Permitted Food Additives Regulations, 2005 (L.N. 54 of 2005)

B 573 L.N. 54 of 2005 FOOD SAFETY ACT (CAP. 448) Permitted Food Additives Regulations, 2005 IN exercise of the powers conferred by article 10 of the Food Safety Act, the Minister of Health, the Elderly and Community Care has made the following regulations> 1.1 The title of these regulations is the Permitted Food Additives Regulations, 2005. 1.2 These regulations shall come into force on the 27th July, 2005, provided that products not conforming with these regulations but which conform with the provisions of the Permitted Food Additives Regulations, 2003, L.N. 347 of 2003 and which have been placed on the market by the 27th January, 2006 at the latest, may be marketed until stocks are exhausted. 1.3 These regulations shall complement the Additives in Food Regulations, 1994. L.N. 89 of 1994 1.4 These regulations implement the provisions of Directive 95 #2 #EC of the European Parliament and of the Council of the 20th February, 1995 on food additives other than colours and sweeteners, as amended by the following Directives> Directive 96 #85 #EC of the European Parliament and of the Council of the 19th December 1996 Directive 98 #72 #EC of the European Parliament and of the Council of the 15th October 1998 Directive 2001 #5 #EC of the European Parliament and of the Council of the 12th February 2001 Directive 2003 #52 #EC of the European Parliament and of the Council of the 18th June 2003 Directive 2003 #114 #EC of the European Parliament and of the Council of the 22nd December 2003. Citation and commencement B 574 2.1 These regulations shall apply to all food additives other than colours, sweeteners, and flavourings. 2.2 These regulations shall apply without prejudice to specific regulations permitting additives listed in the Schedules to these regulations to be used as sweeteners and colours. 2.3 These regulations shall not apply to enzymes other than those mentioned in the Schedules. 3.1 In these regulations, unless the context otherwise requires> 3.1.1 preservatives are substances which prolong the shelf life of foodstuffs by protecting them against deterioration caused by micro-organisms< 3.1.2 antioxidants are substances which prolong the shelf life of foodstuffs by protecting them against deterioration caused by oxidation, such as fat rancidity and colour changes< 3.1.3 carriers, including carrier solvents, are substances used to dissolve, dilute, disperse or otherwise physically modify a food additive without altering its technological function (and without exerting any technological effect themselves) in order to facilitate its handling, application or use< 3.1.4 acids are substances which increase the acidity of a foodstuff and,or impart a sour taste to it< 3.1.5 acidity regulators are substances which alter or control the acidity or alkalinity of a foodstuff< 3.1.6 anti-caking agents are substances which reduce the tendency of individual particles of a foodstuff to adhere to one another< 3.1.7 anti-foaming agents are substances which prevent or reduce foaming< 3.1.8 bulking agents are substances which contribute to the volume of a foodstuff without contributing significantly to its available energy value< 3.1.9 emulsifiers are substances which make it possible to form or maintain a homogenous mixture of two or more immiscible phases such as oil and water in a foodstuff< Applicability of these regulations Interpretation B 575 3.1.10 emulsifying salts are substances which convert proteins contained in cheese into a dispersed form and thereby bring about homogenous distribution of fat and other components< 3.1.11 firming agents are substances which make or keep tissues of fruit or vegetables firm or crisp, or interact with gelling agents to produce or strengthen a gel< 3.1.12 flavour enhancers are substances which enhance the existing taste and,or odour of a foodstuff< 3.1.13 foaming agents are substances which make it possible to form a homogenous dispersion of a gaseous phase in a liquid or solid foodstuff< 3.1.14 gelling agents are substances which give a foodstuff texture through formation of a gel< 3.1.15 glazing agents (including lubricants) are substances which, when applied to the external surface of a foodstuff, impart a shiny appearance or provide a protective coating< 3.1.16 humectants are substances which prevent foodstuffs from drying out by counteracting the effect of an atmosphere having a low degree of humidity, or promote the dissolution of a powder in an aqueous medium< 3.1.17 modified starches are substances obtained by one or more chemical treatments of edible starches, which may have undergone a physical or enzymatic treatment, and may be acid or alkali thinned or bleached< 3.1.18 packaging gases are gases other than air, introduced into a container before, during or after the placing of a foodstuff in that container< 3.1.19 propellants are gases other than air which expel a foodstuff from a container< 3.1.20 raising agents are substances or combinations of substances which liberate gas and thereby increase the volume of a dough or batter< 3.1.21 sequestrants are substances which form chemical complexes with metallic ions< B 576 3.1.22 stabilisers are substances which make it possible to maintain the physico-chemical state of a foodstuff< stabilisers include substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances in a foodstuff and include also substances which stabilise, retain or intensify an existing colour of a foodstuff and substances which increase the binding capacity of the food, including the formation of cross links between proteins enabling the binding of food pieces into reconstituted food< 3.1.23 thickeners are substances which increase the viscosity of a foodstuff< 3.1.24 flour treatment agents other than emulsifiers are substances which are added to flour or dough to improve its baking quality. 3.2 For the purposes of these regulations, the following are not considered as food additives> 3.2.1 substances used for the treatment of drinking water as provided for in Directive 80 #778 #EEC (1)< 3.2.2 products containing pectin and derived from dried apple pomace or peel of citrus fruits, or from a mixture of both, by the action of dilute acid followed by partial neutralisation with sodium or potassium salts (‘liquid pectin’)< 3.2.3 chewing gum bases< 3.2.4 white or yellow dextrin, roasted or dextrinated starch, starch modified by acid or alkali treatment, bleached starch, physically modified starch and starch treated by amylolitic enzymes< 3.2.5 ammonium chloride< 3.2.6 blood plasma, edible gelatine, protein hydrolysates and their salts, milk protein and gluten< 3.2.7 amino acids and their salts other than glutamic acid, glycine, cysteine and cystine and their salts and having no additive function< 3.2.8 caseinates and casein< B 577 3.2.9 inulin. 3.3 Within these regulations, the term ‘unprocessed’ means not having undergone any treatment resulting in a substantial change in the original state of the foodstuffs< however, the foodstuffs may have been, for example, divided, parted, severed, boned, minced, skinned, pared, peeled, ground, cut, cleaned, trimmed, deep-frozen or frozen, chilled, milled or husked, packed or unpacked. 3.4 In these regulations and the Schedules thereto, quantum satis means that no maximum level is specified. However, additives shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided that they do not mislead the consumer. 4.1 Only substances listed in the First, Third, Fourth and Fifth Schedules to these regulations may be used in foodstuffs for the purposes mentioned in regulation 3.1. 4.2 Food additives listed in the First Schedule are permitted in foodstuffs, for the purposes mentioned in regulation 3.1, with the exception of those foodstuffs listed in the Second Schedule, following the quantum satis principle. 4.3 Except where specifically provided for, regulation 4.2 does not apply to> 4.3.1 the following> unprocessed foodstuffs, honey as defined in L.N. 78 #1999, non-emulsified oils and fats of animal or vegetable origin, butter, pasteurised and sterilised (including UHT sterilisation) milk (including skimmed, plain and semi skimmed) and plain pasteurised cream, unflavoured, live fermented milk products, natural mineral water as defined in L.N. 311 #2001 and spring water, Use of additives B 578 coffee (excluding flavoured instant coffee) and coffee extracts, unflavoured leaf tea, sugars as defined in L.N. 77 #1999, dry pasta, excluding gluten-free and #or pasta intended for hypoproteic diets in accordance with L.N. 5 #2002, natural unflavoured buttermilk (excluding sterilised buttermilk)< 4.3.2 foods for infants and young children as referred to in L.N. 5 #2002, including foods for infants and young children not in good health< these foodstuffs are subject to the provisions of the Sixth Schedule< 4.3.3 the foodstuffs listed in the Second Schedule, which may contain only those additives referred to in that Schedule and those additives referred to in the Third and Fourth Schedules under the conditions specified therein. 4.4 Additives listed in the Third and Fourth Schedules may only be used in the foodstuffs referred to in those Schedules and under the conditions specified therein. 4.5 Only those additives listed in the Fifth Schedule may be used as carriers or carrier solvents for food additives and must be used under the conditions specified therein. 4.6 The provisions of these regulations shall also apply to the corresponding foodstuffs intended for particular nutritional uses in accordance with L.N. 5 #2002. 4.7 Maximum levels indicated in the Schedules refer to the foodstuffs as marketed, unless otherwise stated. 4.8 The presence of a food additive in a foodstuff is permissible> 4.8.1 in a compound foodstuff other than one mentioned in regulation 4.3 to the extent to which the food additive is permitted in one of the ingredients of the compound foodstuff, or 4.8.2 in foodstuff where a flavouring has been added, to the extent to which the food additive is permitted in the flavouring B 579 in compliance with these regulations and this has been carried over to the foodstuff via the flavouring, provided the food additive has no technological function in the final foodstuff< 4.8.3 if the foodstuff is destined to be used solely in the preparation of a compound foodstuff and to an extent such that the compound foodstuff conforms to the provisions of these regulations. 4.9 Regulation 4.8 does not apply to infant formulae, follow-on formulae and weaning foods, as referred to in L.N. 5 #2002, except where specifically provided for by these or other Regulations concerning these foods. 4.10 The level of additives in flavourings shall be limited to the minimum necessary to guarantee the safety and quality of flavourings and to facilitate their storage. Furthermore, the presence of additives in flavourings must not mislead consumers or present a hazard to their health. If the presence of an additive in a foodstuff, as a consequence of adding flavourings, has a technological function in the foodstuff, it shall be considered as an additive of the foodstuff and not as an additive of the flavouring. 4.11 No person may import, sell, keep for sale, or supply by way of compensation or otherwise, any food additive or any food containing such additive in either case unless in compliance with the provisions of these regulations. 5.1 The Permitted Food Additives Regulations, 2003 are hereby repealed. 5.2 References in other regulations to the Permitted Food Additives Regulations, 2003 shall henceforth be construed as references to these regulations. 6.1 The additives permitted for use by these regulations must satisfy the purity criteria laid down by Commission Directive 96 #77 #EC as amended by Directives 98 #86 #EC, 2000 #63 #EC, 2001 #30 #EC, 2002 #82 #EC, 2003 #95 #EC and 2004 #45 #EC. A list of the food additives for which purity criteria have been established is given in the Seventh Schedule 6.2 The methods of analysis described in Commission Directive 81 #712 #EEC shall be used in order to ascertain for purposes of official Repeal of L.N. 347 of 2003. Purity criteria and methods of analysis B 580 control whether certain additives permitted for use by these regulations satisfy the prescribed purity criteria. 6.3 The taking of samples and the qualitative and quantitative analysis of biphenyl, orthophenyl phenol and sodium orthophenylphenol in and on citrus fruit shall be carried out in accordance with the provisions of Annexes I, II, III and IV to Council Directive 67 #427 #EEC. B 581 FIRST SCHEDULE Food Additives generally permitted for use in Foodstuffs not referred to in regulation 4.3.1 Note: 1. Substances on this list may be added to all foodstuffs with the exception of those referred to in regulation 4.3.1 following the quantum satis principle. 2. The substances listed under numbers E 407, E 407a and E 440 may be standardized with sugars, on condition that this is stated in addition to the number and designation. 3. Explanation of symbols used: * The substances E 290, E 938, E 939, E 941, E 942, E 948 and E 949 may also be used in the foodstuffs referred to in regulation 4.3.1. # The substances E 410, E 412, E 415 and E 417 may not be used to produce dehydrated foodstuffs intended to rehydrate on ingestion. E No Name B 582 E No Name i) Monosodium citrate ii) Disodium citrate iii) Trisodium citrate E 332 Potassium citrates i) Monopotassium citrate ii) Tripotassium citrate E 333 Calcium citrates i) Monocalcium citrate ii) Dicalcium citrate iii) Tricalcium citrate E 334 Tartaric acid (L(+)-) E 335 Sodium tartrates i) Monosodium tartrate ii) Disodium tartrate E 336 Potassium tartrates i) Monopotassium tartrate ii) Dipotassium tartrate E 337 Sodium potassium tartrate E 350 Sodium malates i) Sodium malate ii) Sodium hydrogen malate E 351 Potassium malate E 352 Calcium malates i) Calcium malate ii) Calcium hydrogen malate E 354 Calcium tartrate E 380 Triammonium citrate E 400 Alginic acid E 401 Sodium alginate E 402 Potassium alginate E 403 Ammonium alginate E 404 Calcium alginate E 406 Agar E 407 Carrageenan E 407a Processed eucheuma seaweed E 410 Locust bean gum E 412 Guar gum E 413 Tragacanth E 414 Acacia gum (gum arabic) E 415 Xanthan gum E 417 Tara gum E 418 Gellan gum E 422 Glycerol E 440 Pectins i) Pectin B 583 E No Name ii) Amidated pectin E 460 Cellulose i) Microcrystalline cellulose ii) Powdered cellulose E 461 Methyl cellulose E 463 Hydroxypropyl cellulose E 464 Hydroxypropyl methyl cellulose E 465 Ethyl methyl cellulose E 466 Carboxy methyl cellulose Sodium carboxy methyl cellulose Cellulose gum E 469 Enzymatically hydrolysed carboxy methyl cellulose Enzymatically hydroloysed cellulose gum E 470a Sodium, potassium and calcium salts of fatty acids E 470b Magnesium salts of fatty acids E 471 Mono- and diglycerides of fatty acids E 472a Acetic acid esters of mono- and diglycerides of fatty acids E 472b Lactic acid esters of mono- and diglycerides of fatty acids E 472c Citric acid esters of mono- and diglycerides of fatty acids E 472d Tartaric acid esters of mono- and diglycerides of fatty acids E 472e Mono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids E 472f Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids E 500 Sodium carbonates i) Sodium carbonate ii) Sodium hydrogen carbonate iii) Sodium sesquicarbonate E 501 Potassium carbonates i) Potassium carbonate ii) Potassium hydrogen carbonate E 503 Ammonium carbonates i) Ammonium carbonate ii) Ammonium hydrogen carbonate E 504 Magnesium carbonates i) Magnesium carbonate ii) Magnesium hydrogen carbonate E 507 Hydrochloric acid E 508 Potassium chloride E 509 Calcium chloride E 511 Magnesium chloride E 513 Sulphuric acid E 514 Sodium sulphates i) Sodium sulphate B 584 E No Name ii) Sodium hydrogen sulphate E 515 Potassium sulphates i) Potassium sulphate ii) Potassium hydrogen sulphate E 516 Calcium sulphate E 524 Sodium hydroxide E 525 Potassium hydroxide E 526 Calcium hydroxide E 527 Ammonium hydroxide E 528 Magnesium hydroxide E 529 Calcium oxide E 530 Magnesium oxide E 570 Fatty acids E 574 Gluconic acid E 575 Glucono-delta-lactone E 576 Sodium gluconate E 577 Potassium gluconate E 578 Calcium gluconate E 640 Glycine and its sodium salt E 920 (2) L-Cysteine E 938 Argon * E 939 Helium * E 941 Nitrogen * E 942 Nitrous oxide * E 948 Oxygen * E 949 Hydrogen * E 1103 Invertase E 1200 Polydextrose E 1404 Oxidized starch E 1410 Monostarch phosphate E 1412 Distarch phosphate E 1413 Phosphated distarch phosphate E 1414 Acetylated distarch phosphate E 1420 Acetylated starch E 1422 Acetylated distarch adipate E 1440 Hydroxy propyl starch E 1442 Hydroxy propyl distarch phosphate E 1450 Starch sodium octenyl succinate E 1451 Acetylated oxidised starch 2 May be used only as a flour treatment agent. B 585 SECOND SCHEDULE Foodstuffs in which a limited number of Additives of the First Schedule may be used Foodstuff Additive Maximum level E 330 Citric acid 0.5 % E 322 Lecithins Quantum satis E 334 Tartaric acid 0.5 % E 422 Glycerol Quantum satis E 471 Mono- and diglycerides of fatty acids Quantum satis E 472c Citric acid esters of mono- and diglycerides of fatty acids Quantum satis E 170 Calcium carbonate E 500 Sodium carbonates E 501 Potassium carbonates E 503 Ammonium carbonates E 504 Magnesium carbonates E 524 Sodium hydroxide E 525 Potassium hydroxide E 526 Calcium hydroxide E 527 Ammonium hydroxide E 528 Magnesium hydroxide E 530 Magnesium oxide 7 % on dry matter without fat expressed as potassium carbonates E 414 Acacia gum Cocoa and chocolate products as defined in L.N. 317/2001 E 440 Pectins As glazing agents only quantum satis Fruit juices and nectars as defined in L.N. 242/1998 E 300 Ascorbic acid Quantum satis Pineapple juice as defined in L.N. 242/1998 E 296 Malic acid 3 g/l E 330 Citric acid 5 g/l Nectars as defined in L.N. 242/1998 E 270 Lactic acid 5 g/l E 170 Calcium carbonate Quantum satis Grape juice as defined in L.N. 242/1998 E 336 Potassium tartrates Quantum satis Fruit juices as defined in L.N. 242/1998 E 330 Citric acid 3 g/l E 440 Pectins E 296 Malic acid Extra jam and extra jelly, as defined in L.N. 79/1999 E 300 Ascorbic acid B 586 Foodstuff Additive Maximum level E 327 Calcium lactate E 330 Citric acid E 331 Sodium citrates E 333 Calcium citrates E 334 Tartaric acid E 335 Sodium tartrates E 350 Sodium malates E 471 Mono- and diglycerides of fatty acids Quantum satis E 440 Pectins Quantum satis E 270 Lactic acid E 296 Malic acid E 300 Ascorbic acid E 327 Calcium lactate E 330 Citric acid E 331 Sodium citrates E 333 Calcium citrates E 334 Tartaric acid E 335 Sodium tartrates E 350 Sodium malates Quantum satis E 400 Alginic acid E 401 Sodium alginate E 402 Potassium alginate E 403 Ammonium alginate E 404 Calcium alginate E 406 Agar E 407 Carrageenan E 410 Locust bean gum E 412 Guar gum E 415 Xanthan gum E 418 Gellan gum 10 g/kg (individually or in combination) E 471 Mono and diglycerides of fatty acids Quantum satis E 509 Calc ium chloride Jams, jellies and marmalades as defined in L.N. 79/1999 and other similar fruit spreads including low-calorie products E 524 Sodium hydroxide Quantum satis E 300 Ascorbic acid E 301 Sodium ascorbate E 304 Fatty acid esters of ascorbic acid E 322 Lecithins E 331 Sodium citrates E 332 Potassium citrates Partially dehydrated and dehydrated milk as defined in L.N. 15/2002 E 407 Carrageenan Quantum satis B 587 Foodstuff Additive Maximum level E 500 ii) Sodium bicarbonate E 501 ii) Potassium bicarbonate E 509 Calcium chloride E 401 Sodium alginate E 402 Potassium alginate E 407 Carrageenan E 466 Sodium carboxy methyl cellulose Plain pasteurised cream E 471 Mono and diglycerides Quantum satis Frozen and deep-frozen unprocessed fruit and vegetables; pre-packed, refrigerated unprocessed fruit and vegetables ready for consumption and pre packed unprocessed and peeled potatoes E 296 Malic acid (only for peeled potatoes) E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates E 333 Calcium citrates Quantum satis Fruit compote E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates E 333 Calcium citrates E 440 Pectin (only for fruit compote other than apple) E 509 Calcium chloride (only for fruit compote other than apple) Quantum satis Unprocessed fish, crustaceans and molluscs, including such products frozen and deep-frozen E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates E 333 Calcium citrates Quantum satis E 471 Mono- and diglycerides of fatty acids Quick cook rice E 472a Acetic acid esters of mono- and diglycerides of fatty acids Quantum satis B 588 Foodstuff Additive Maximum level E 304 Fatty acid esters of ascorbic acid E 306 Tocopherol-rich extract E 307 Alpha-tocopherol E 308 Gamma-tocopherol E 309 Delta-tocopherol Quantum satis E 322 Lecithins 30 g/l E 471 Mono- and diglycerides of fatty acids 10 g/l E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates Non emulsified oils and fats of animal or vegetable origin (except virgin oils and olive oils) E 333 Calcium citrates Quantum satis E 270 Lactic acid E 300 Ascorbic acid E 304 Fatty acid esters of ascorbic acid E 306 Tocopherol-rich extract E 307 Alpha-tocopherol E 308 Gamma-tocopherol E 309 Delta-tocopherol Quantum satis E 322 Lecithins 30 g/l E 471 Mono- and diglycerides of fatty acids 10 g/l E 472c Citric acid esters of mono- and diglycerides of fatty acids E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates Non-emulsified oils and fats of animal or vegetable origin (except virgin oils and olive oils) specifically intended for cooking and/or frying purposes or for the preparation of gravy E 333 Calcium citrates Quantum satis Refined olive oil, including olive pomace oil E 307 Alpha-tocopherol 200 mg/l E 170 Calcium carbonate E 504 Magnesium carbonates E 509 Calcium chloride Ripened cheese E 575 Glucono-delta lactone Quantum satis E 260 Acetic acid E 270 Lactic acid Mozzarella and whey cheese E 330 Citric acid Quantum satis B 589 Foodstuff Additive Maximum level E 460ii Powdered cellulose (only for grated and sliced cheese) E 575 Glucono-delta lactone E 260 Acetic acid E 261 Potassium acetate E 262 Sodium acetates E 263 Calcium acetate E 270 Lactic acid E 296 Malic acid E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 325 Sodium lactate E 326 Potassium lactate E 327 Calcium lactate E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates E 333 Calcium citrates E 334 Tartaric acid E 335 Sodium tartrates E 336 Potassium tartrates E 337 Sodium potassium tartrate E 509 Calcium chloride Canned and bottled fruit and vegetables E 575 Glucono-delta lactone Quantum satis B 590 Foodstuff Additive Maximum level E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates Gehakt E 333 Calcium citrates Quantum satis E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates Pre-packed preparations of fresh minced meat E 333 Calcium citrates Quantum satis E 260 Acetic acid E 261 Potassium acetate E 262 Sodium acetates E 263 Calcium acetate E 270 Lactic acid E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 304 Fatty acid esters of ascorbic acid E 322 Lecithins E 325 Sodium lactate E 326 Potassium lactate E 327 Calcium lactate E 471 Mono- and diglycerides of fatty acids E 472a Acetic acid esters of mono- and diglycerides of fatty acids E 472d Tartaric acid esters of mono- and diglycerides of fatty acids E 472e Mono- and diacetyl tartaric acid esters of mono and diglycerides of fatty acids Bread prepared solely with the following ingredients: wheat flour, water, yeast or leaven, salt E 472f Mixed acetic and tartaric acid esters of mono and diglycerides of fatty acids Quantum satis B 591 Foodstuff Additive Maximum level E 260 Acetic acid E 261 Potassium acetate E 262 Sodium acetates E 263 Calcium acetate E 270 Lactic acid E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 304 Fatty acid esters of ascorbic acid E 322 Lecithins E 325 Sodium lactate E 326 Potassium lactate E 327 Calcium lactate Pain courant français E 471 Mono- and diglycerides of fatty acids Quantum satis E 270 Lactic acid E 300 Ascorbic acid E 301 Sodium ascorbate E 322 Lecithins E 330 Citric acid E 334 Tartaric acid E 471 Mono- and diglycerides of fatty acids Fresh pasta E 575 Glucono-delta lactone Quantum satis Wines and sparkling wines and partially fermented grape must Additives authorised: In accordance with Regulations (EEC) No 822/87 (3), (EEC) No 4252/88 (4), (EEC) No 2332/92 (5) and (EEC) No 1873/84 (6) and their implementing regulations, In accordance with Regulation (EEC) No 1873/84 authorizing the offer or disposal for direct pro memoria 3 OJ No L 84, 27.3.1987,p.1 4 OJ No L 373, 31.12.1988, p.59 5 OJ No L 231, 13.8.1992, p.1 6 OJ No L 176, 3.7.1984, p.6 B 592 Foodstuff Additive Maximum level human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79 E 270 Lactic acid E 300 Ascorbic acid E 301 Sodium ascorbate E 330 Citric acid Beer E 414 Acacia gum Quantum satis E 300 Ascorbic acid Foie gras, foie gras entier, blocs de foie gras E 301 Sodium ascorbate Quantum satis Pineapple and passion fruit juices and nectars E 440 Pectins 3 g/l E 170 Calcium carbonate E 504 Magnesium carbonates E 509 Calcium chloride E 575 Glucono-delta lactone Sliced and grated ripened cheese E 460 Celluloses Quantum satis Soured-cream butter E 500 Sodium carbonates Quantum satis UHT goat milk E 331 Sodium citrates 4 g/l Chestnuts in liquid E 410 Locust bean gum E 412 Guar gum E 415 Xanthan gum Quantum satis B 593 THIRD SCHEDULE Conditionally Permitted Preservatives and Antioxidants PART A Sorbates, benzoates and p-hydroxybenzoates E No Name Abbreviation E 200 Sorbic acid E 202 Potassium sorbate E 203 Calcium sorbate Sa E 210 Benzoic acid E 211 Sodium benzoate E 212 Potassium benzoate E 213 Calcium benzoate Ba (7) E 214 Ethyl p-hydroxybenzoate E 215 Sodium ethyl p-hydroxybenzoate E 216 Propyl p-hydroxybenzoate E 217 Sodium propyl p-hydroxybenzoate E 218 Methyl p-hydroxybenzoate E 219 Sodium methyl p-hydroxybenzoate PHB Note: 1. The levels of all substances mentioned above are expressed as the free acid. 2. The abbreviations used in the table mean the following: — Sa + Ba: Sa and Ba used singly or in combination — Sa+ PHB: Saa nd PHB used singly or in combination — Sa + Ba + PHB: Sa, Ba and PHB used singly or in combination. 3. The maximum levels of use indicated refer to foodstuffs ready for consumption prepared following manufacturers' instructions. 7 Benzoic acid may be present in certain fermented products resulting from the fermentation process following good manufacturing practice. B 594 Maximum level (mg/kg or mg/l as appropriate) Foodstuff Sa Ba PHB Sa+Ba Sa+PHB Sa+Ba+PHB Wine-based flavoured drinks including products covered by Regulation (EEC) No 1601/91 200 Non-alcoholic flavoured drinks (8) 300 150 250 Sa + 150 Ba Liquid tea concentrates and liquid fruit and herbal infusion concentrates 600 Grape juice, unfermented, for sacramental use 2000 Wines as referred to in Regulation (EEC) No 822/87; alcohol- free wine; fruit wine (including alcohol- free); Made wine; cider and perry (including alcohol- free) 200 Sød…Saft or sødet…Saft 500 200 Alcohol- free beer in keg 200 Mead 200 Spirits with less than 15 % alcohol by volume 200 200 400 Fillings of ravioli and similar products 1000 Low-sugar jams, jellies, marmalades and similar low calorie or sugar-free products and other fruit based spreads Mermeladas 500 1000 Candied, crystallized and glace fruit and vegetables 1000 Dried fruit 1000 Frugtgrød and Rote 1000 500 8 This entry does not include dairy-based drinks B 595 Maximum level (mg/kg or mg/l as appropriate) Foodstuff Sa Ba PHB Sa+Ba Sa+PHB Sa+Ba+PHB Grütze Fruit and vegetable preparations including fruit-based sauces, excluding purée, mousse, compote, salads and similar products, canned or bottled 1000 Vegetables in vinegar, brine or oil (excluding olives) 2000 Potato dough and pre fried potato slices 2000 Gnocchi 1000 Polenta 200 Olives and olive-based preparations 1000 500 1000 Jelly coatings of meat products (cooked, cured or dried); Pâté 1000 Surface treatment of dried meat products quantum satis Semi-preserved fish products including fish roe products 2000 Salted, dried fish 200 Shrimps, cooked 2000 Crangon crangon and Crangon vulgaris, cooked 6000 Cheese, pre-packed, sliced 1000 Unripened cheese 1000 Processed cheese 2000 Layered cheese and cheese with added foodstuffs 1000 Non-heat-treated dairy based desserts 300 Curdled milk 1000 Liquid egg (white, yolk or whole egg) 5000 Dehydrated, 1000 B 596 Maximum level (mg/kg or mg/l as appropriate) Foodstuff Sa Ba PHB Sa+Ba Sa+PHB Sa+Ba+PHB concentrated, frozen and deep-frozen egg products Pre-packed sliced bread and rye bread 2000 Partially baked, pre packed bakery wares intended for retail sale and energy reduced bread intended for retail sale 2000 Fine bakery wares with a water activity of more than 0.65 2000 Cereal- or potato-based snacks and coated nuts 1000 (max 300 PHB) Batters 2000 Confectionery (excluding chocolate) 1500 (max 300 PHB) Chewing gum 1500 Toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream; similar products) 1000 Fat emulsions (excluding butter) with a fat content of 60 % or more 1000 Fat emulsions with a fat content less than 60 % 2000 Emulsified sauces with a fat content of 60 % or more 1000 500 1000 Emulsified sauces with a fat content less than 60 % 2000 1000 2000 Non-emulsified sauces 1000 Prepared salads 1500 Mustard 1000 Seasonings and condiments 1000 B 597 Maximum level (mg/kg or mg/l as appropriate) Foodstuff Sa Ba PHB Sa+Ba Sa+PHB Sa+Ba+PHB Liquid soups and broths (excluding canned) 500 Aspic 1000 500 Liquid dietary food supplements 2000 Dietetic foods intended for special medical purposes excluding foods for infants and young children as referred to in Directive 89/398/EEC (9) – dietetic formulae for weight control intended to replace total daily food intake or an individual meal 1500 ..Mehu and Makeutettu…Mehu 500 200 Analogues of meat, fish, crustaceans and cephalopods and cheese based on protein 2000 Dulce de membrillo 1000 Marmelada 1500 Ostkaka 2000 Pasha 1000 Semmelknödelteig 2000 Cheese and cheese analogues (surface treatment only) quantum satis Cooked red beet 2000 Collagen-based casings with a water activity greater than 0.6 quantum satis Crayfish tails, cooked, and prepacked marinated cooked molluscs 2000 Flavourings 1500 9 OJ No L 186, 30.6.1989, p.27 B 598 PART B Sulphur dioxide and sulphites E No Name E 220 Sulphur dioxide E 221 Sodium sulphite E 222 Sodium hydrogen sulphite E 223 Sodium metabisulphite E 224 Potassium metabisulphite E 226 Calcium sulphite E 227 Calcium hydrogen sulphite E 228 Potassium hydrogen sulphite Note: 1. Maximum levels are expressed as SO2 in mg/kg or mg/l as appropriate and relate to the total quantity, available from all sources. 2. An SO2 content of not more than 10 mg/kg or 10 mg/l is not considered to be present. Foodstuff Maximum level (mg/kg or mg/l as appropriate). Expressed as SO2 Burger meat with a minimum vegetable and/or cereal content of 4 % 450 B 599 Foodstuff Maximum level (mg/kg or mg/l as appropriate). Expressed as SO2 Breakfast sausages 450 Longaniza fresca and butifarra fresca 450 Dried salted fish of the ‘Gadidae’ species 200 Crustaceans and cephalopods: fresh, frozen and deep-frozen crustaceans, panaeidae solenceridae, aristeidae family: up to 80 units between 80 and 120 units over 120 units cooked 150 (10) 150 (10) 200 (10) 300 (10) 50 (10) Dry biscuit 50 Starches (excluding starches for weaning foods, follow-on formulae and infant formulae) 50 Sago 30 Pearl barley 30 Dehydrated potatoes 400 Cereal- and potato-based snacks 50 Peeled potatoes 50 Processed potatoes (including frozen and deep-frozen potatoes) 100 Potato dough 100 White vegetables, dried 400 White vegetables, processed (including frozen and deep-frozen white vegetables) 50 Dried ginger 150 Dried tomatoes 200 Horseradish pulp 800 Onion, garlic and shallot pulp 300 Vegetables and fruits in vinegar, oil or brine (except olives and golden peppers in brine) 100 Golden peppers in brine 500 Processed mushrooms (including frozen mushrooms) 50 Dried mushrooms 100 Dried fruits 10 In edible parts. B 600 Foodstuff Maximum level (mg/kg or mg/l as appropriate). Expressed as SO2 apricots, peaches, grapes, prunes and figs bananas apples and pears other (including nuts in shell) 2000 1000 600 500 B 601 Foodstuff Maximum level (mg/kg or mg/l as appropriate). Expressed as SO2 Dried coconut 50 Candied, crystallized or glace fruit, vegetables, angelica and citrus peel 100 Jam, jelly and marmalade as defined in L.N. 79/1999 (except extra jam and extra jelly) and other similar fruit spreads including low-calorie products 50 Jams, jellies and marmalades made with sulphited fruit 100 Fruit-based pie fillings 100 Citrus-juice-based seasonings 200 Concentrated grape juice for home wine-making 2000 Mostarda di frutta 100 Jellying fruit extract, liquid pectin for sale to the final consumer 800 Bottled whiteheart cherries, rehydrated dried fruit and lychees 100 Bottled, sliced lemon 250 Sugars as defined in L.N. 77/1999 except glucose syrup, whether or not dehydrated 10 Glucose syrup, whether or not dehydrated 20 Treacle and molasses 70 Other sugars 40 Toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream; similar products) 40 Orange, grapefruit, apple and pineapple juice for bulk dispensing in catering establishments 50 Lime and lemon juice 350 Concentrates based on fruit juice and containing not less than 2.5 % barley (barley water) 350 Other concentrates based on fruit juice or comminuted fruit; Capilé groselha 250 Non-alcoholic flavoured drinks containing fruit juice 20 (carry-over from concentrates only) Non-alcoholic flavoured drinks containing at least 235 g/l glucose 50 B 602 Foodstuff Maximum level (mg/kg or mg/l as appropriate). Expressed as SO2 syrup Grape juice, unfermented, for sacramental use 70 Glucose syrup-based confectionery 50 (carry-over from the glucose syrup only) Beer including low-alcohol and alcohol- free beer 20 Beer with a second fermentation in the cask 50 Wines In accordance with Regulations (EEC) No 822/87, (EEC) No 4252/88, (EEC) No 2332/92 and (EEC) No 1873/84 and their implementing regulations; (pro memoria) in accordance with Regulation (EEC) No 1873/84 authorizing the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79. Alcohol- free wine 200 Made wine 260 Cider, perry, fruit wine, sparkling fruit wine (including alcohol- free products) 200 Mead 200 Fermentation vinegar 170 Mustard, excluding Dijon mustard 250 Dijon mustard 500 Gelatin 50 Vegetable- and cereal-protein-based meat, fish and crustacean analogues 200 Analogues of meat, fish and crustaceans based on protein 200 Marinated nuts 50 Vacuum packed sweetcorn 100 Distilled alcoholic beverages containing whole pears 50 B 603 PART C Other preservatives E No Name Foodstuff Maximum level E 231 Orthophenyl phenol 11 E 232 Sodium orthophenyl phenol 11 Surface treatment of citrus fruits 12 mg/kg individually or in combination expressed as orthophenyl phenol Semolina and tapioca puddings and similar products 3 mg/kg Ripened cheese and processed cheese 12.5 mg/kg Clotted cream 10 mg/kg E 234 Nisin (12) Mascarpone 10 mg/kg E 235 Natamycin Surface treatment of: hard, semi-hard and semi-soft cheese dried, cured sausages 1 mg/dm2 surface (not present at a depth of 5 mm) E 239 Hexamethylene tetramine Provolone cheese 25 mg/kg residual amount, expressed as formaldehyde E 242 Dimethyl dicarbonate Non-alcoholic flavoured drinks Alcohol- free wine Liquid tea concentrate 250 mg/l ingoing amount, residues not detectable E 284 Boric acid E 285 Sodium tetraborate (Borax) Sturgeons’ eggs (Caviar) 4 g/kg, expressed as boric acid 11 The use of biphenyl (diphenyl) for the surface treatment of citrus fruit is not permitted. The use of E 231 orthophenyl phenol and E 232 sodium orthophenyl phenol for this same purpose shall no longer be permitted as soon as requirements for the labelling of foodstuffs treated with these substances become applicable under the Pesticides Control Act. 12 This substance may be present naturally in certain cheeses as a result of fermentation processes. B 604 E No Name Foodstuff Indicative ingoing amount Residual amount mg/kg Non-heat-treated, cured, dried meat products 150 (14) 50 (15) Other cured meat products Canned meat products Foie gras, foie gras entier, blocs de foie gras 150 (14) 100 (15) E 249 E 250 Potassium nitrite (13) Sodium nitrite (13) Cured bacon 175 (15) Cured meat products Canned meat products 300 250 (16) E 251 Sodium nitrate Foie gras, foie gras entier, blocs de foie gras 50 (16) Hard, semi-hard and semi soft cheese Dairy-based cheese analogue 50 (16) Pickled herring and sprat 200 (17) E 252 Potassium nitrate Foie gras, foie gras entier, blocs de foie gras 50 (16) E No Name Foodstuff Maximum level Pre-packed sliced bread and rye bread 3000 mg/kg expressed as propionic acid Energy-reduced bread Partially baked, pre-packed bread Pre-packed fine bakery wares (including flour confectionery) with a water activity of more than 0.65 Pre-packed Rolls, and pitta 2000 mg/kg expressed as propionic acid Christmas pudding Pre-packed bread 1000 mg/kg expressed as propionic acid E 280 E 281 E 282 E 283 Propionic acid Sodium propionate Calcium propionate Potassium propionate Pre-packed pølsebrød, boller and dansk flutes 2000 mg/kg expressed as propionic acid 13 When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute. 14 Expressed as NaNO2. 15 Residual amount at point of sale to the final consumer, expressed as NaNO2. 16 Expressed as NaNO3. 17 Residual amount, nitrite formed from nitrate included, expressed as NaNO2. B 605 E No Name Foodstuff Maximum level Cheese and cheese analogues (surface treatment only) quantum satis Ripened cheese quantum satis E 1105 Lysozyme Wine in accordance with Regulation (EC) No 1493/1999 (18) and its implementing Regulation (EC) No 1622/2000 (19) pro memoria 18 Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (OJ L 179, 14.7.1999, p.1). Regulation as last amended by Commission Regulation (EC) No 1795/2003 (OJ L 262, 14.10.2003, p.1). 19 Commission Regulation (EC) No 1622/2000 of 24 July 2000 laying down certain detailed rules for implementing Regulation (EC) No 1493/1999 on the common organisation of the market in wine and establishing a Community code of oenological practices and processes (OJ L 194, 31.7.2000, p.1). Regulation as last amended by Regulation (EC) No 1410/2003 (OJ L 201, 8.8.2003, p.9). B 606 PART D Other antioxidants Note: The * in the table refers to the proportionality rule: when combinations of gallates, BHA and BHT are used, the individual levels must be reduced proportionally. E No Name Foodstuff Maximum level (mg/kg) Fats and oils for the professional manufacture of heat-treated foodstuffs Frying oil and frying fat, excluding olive pomace oil Lard; fish oil; beef, poultry and sheep fat 200 * (gallates and BHA, individually or in combination) 100 * (BHT) both expressed on fat Cake mixes Cereal-based snack foods Milk powder for vending machines Dehydrated soups and broths Sauces Dehydrated meat Processed nuts Seasonings and condiments Pre-cooked cereals 200 (gallates and BHA, individually or in combination) Dehydrated potatoes 25 (gallates and BHA, individually or in combination) E 310 E 311 E 312 E 320 E 321 Propyl gallate Octyl gallate Dodecyl gallate Butylated hydroxyanisole (BHA) Butylated hydroxytoluene (BHT) Chewing gum Dietary supplements 400 (gallates, BHT and BHA, individually or in combination) Cured meat products and preserved meat products 500 expressed as erythorbic acid E 315 E 316 Erythorbic acid Sodium erythorbate Preserved and semi -preserved fish products Frozen and deep-frozen fish with red skin 1500 expressed as erythorbic acid Essential oils 1000 mg/kg (gallates and BHA, individually or in combination) E 310 E 311 E 312 E 320 Propyl gallate Octyl gallate Dodecyl gallate Butylated hydroxyanisole (BHA) Flavourings other than essential oils 100 mg/kg (gallates, individually or in combination) or 200 mg/kg (BHA) B 607 FOURTH SCHEDULE Other Permitted Additives The maximum levels of use indicated refer to foodstuffs ready for consumption prepared following manufacturers’ instructions. E No Name Foodstuff Maximum level (pro memoria) Wine in accordance with Regulation (EEC) No 1873/84 authorizing the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79 Fillings and toppings for fine bakery wares 2.5 mg/kg Sugar confectionery 1 g/kg Gel- like desserts Fruit- flavoured desserts Dry powdered dessert mixes 4 g/kg Instant powders for fruit based drinks 1 g/l Instant powders for preparation of flavoured tea and herbal infusions 1 g/kg E 297 Fumaric acid Chewing gum 2 g/kg In the following applications the indicated maximum levels of phosphoric acid and the phosphates E 338, E 339, E 340, E 341, E 343, E 450, E 451 and E 452 may be added individually or in combination (expressed as P2O5): Non-alcoholic flavoured drinks 700 mg/l Sterilised and UHT milk 1 g/l Candied fruits 800 mg/kg Fruit preparations 800 mg/kg E 338 E 339 Phosphoric acid Sodium phosphates i) Monosodium phosphate ii) Disodium phosphate Partly dehydrated milk with less than 28 % solids 1 g/kg B 608 E No Name Foodstuff Maximum level Partly dehydrated milk with more than 28 % solids 1.5 g/kg Dried milk and dried skimmed milk 2.5 g/kg Pasteurised, sterilised and UHT creams 5 g/kg Whipped cream and vegetable fat analogues 5 g/kg Unripened cheese (except Mozzarella) 2 g/kg Processed cheese and processed cheese analogues 20 g/kg Meat products 5 g/kg Sport drinks and prepared table waters 0.5 g/l Dietary supplements quantum satis Salt and its substitutes 10 g/kg Vegetable protein drinks 20 g/l Beverage whiteners 30 g/kg Beverage whiteners for vending machines 50 g/kg Edible ices 1 g/kg Desserts 3 g/kg Dry powdered dessert mixes 7 g/kg Fine bakery wares 20 g/kg Flour 2.5 g/kg Flour, self-raising 20 g/kg Soda bread 20 g/kg Liquid egg (white, yolk or whole egg) 10 g/kg Sauces 5 g/kg Soups and broths 3 g/kg Instant tea and instant herbal infusions 2 g/kg Chewing gum quantum satis Dried powdered foodstuffs 10 g/kg Chocolate and malt dairy based drinks 2 g/l E 340 E341 E 343 E 450 E 451 iii) Trisodium phosphate Potassium phosphates i) Monopotassium phosphate ii) Dipotassium phosphate iii) Tripotassium phosphate Calcium phosphate i) Monocalcium phosphate ii) Dicalcium phosphate iii) Tricalcium phosphate Magnesium phosphates i) Monomagnesium phosphate ii) Dimagnesium phosphate Diphosphates i) Disodium diphosphate ii) Trisodium diphosphate iii) Tetrasodium diphosphate v) Tetrapotassium phosphate vi) Dicalcium diphosphate vii) Calcium dihydrogen diphosphate Triphosphates i) Pentasodium triphosphate ii) Pentapotassium Alcoholic drinks (excluding wine and beer) 1 g/l B 609 E No Name Foodstuff Maximum level Breakfast cereals 5 g/kg Snacks 5 g/kg Surimi 1 g/kg Fish and crustacean paste 5 g/kg Toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream; similar products) 3 g/kg Special formulae for particular nutritional uses 5 g/kg Glazings for meat and vegetable products 4 g/kg Sugar confectionery 5 g/kg Icing sugar 10 g/kg Noodles 2 g/kg Batters 12 g/kg Fillets of unprocessed fish, frozen and deep-frozen 5 g/kg Unprocessed and processed molluscs and crustaceans frozen and deep-frozen 5 g/kg Processed potato products (including frozen, deep frozen, chilled and dried processed products) and pre-fried frozen and deep frozen potatoes 5 g/kg Spreadable fats excluding butter 5 g/kg Beurre de crème acide 2 g/kg Canned crustacean products 1 g/kg Waterbased emulsion sprays for coating baking tins 30 g/kg Coffee based drinks for vending machines 2 g/l E 452 triphosphate Polyphosphates i) Sodium polyphosphate ii) Potassium polyphosphate iii) Sodium calcium polyphosphate iv) Calcium polyphosphate Flavourings 40 g/kg E 468 Crosslinked sodium carboxy methyl cellulose Solid dietary supplements 30 g/kg B 610 E No Name Foodstuff Maximum level E 431 Polyoxyethylene (40) stearate (pro memoria) Wine in accordance with Regulation (EEC) No 1873/84 authorizing the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79 Wine in accordance with Regulations (EEC) No 822/87, (EEC) No 4252/88, (EEC) No 2332/92 and (EEC) No 1873/84 and their implementing regulations E 353 Metatartaric acid Made wine 100 mg/l Fillings and toppings for fine bakery wares 2 g/kg Dry powdered dessert mixes 1 g/kg Gel- like desserts 6 g/kg Fruit- flavoured desserts 1 g/kg E 355 E 356 E 357 Adipic acid Sodium adipate Potassium adipate Powders for home preparation of drinks 10 g/l expressed as adipic acid Desserts 6 g/kg Soups and broths 5 g/kg E 363 Succinic acid Powders for home preparation of drinks 3 g/l Emulsified sauces 75 mg/kg Canned and bottled pulses, legumes, mushrooms and artichokes 250 mg/kg Canned and bottled crustaceans and molluscs 75 mg/kg E 385 Calcium disodium ethylene diamine tetraacetate (Calcium disodium EDTA) Canned and bottled fish 75 mg/kg B 611 E No Name Foodstuff Maximum level Spreadable fats as defined in Annexes B and C of Regulation (EC) No 2991/94 (20), having a fat content of 41 % or less 100 mg/kg Frozen and deep-frozen crustaceans 75 mg/kg Fat emulsions 3 g/kg Fine bakery wares 2 g/kg Fillings, toppings and coatings for fine bakery wares and desserts 5 g/kg Sugar confectionery 1.5 g/kg Water-based edible ices 3 g/kg Cereal- and potato-based snacks 3 g/kg Sauces 8 g/kg Beer 100 mg/l Chewing gum 5 g/kg Fruit and vegetable preparations 5 g/kg Non-alcoholic flavoured drinks 300 mg/l Emulsified liqueur 10 g/l Dietetic foods intended for special medical purposes – Dietetic formulae for weight control intended to replace total daily food intake or an individual meal 1.2 g/kg Dietary food supplements 1 g/kg E 405 Propane-1,2-diol alginate Cider excluding cidre bouché 100 mg/l Cereal- and potato-based snacks 5 g/kg Nut coatings 10 g/kg Fillings, toppings and coatings for fine bakery wares 5 g/kg Desserts 6 g/kg Emulsified sauces 10 g/kg E 416 Karaya gum Egg-based liqueurs 10 g/l 20 OJ L 316, 9.12.1994, p.2 B 612 E No Name Foodstuff Maximum level Dietary food supplements quantum satis Chewing gum 5 g/kg Flavourings 50 g/kg Foodstuffs in general (except drinks and those foodstuffs referred to in regulation 4.3.1) Frozen and deep-frozen unprocessed fish, crustaceans, molluscs and cephalopods E 420 E 421 E 953 E 965 E 966 E 967 Sorbitol (i) Sorbitol (ii) Sorbitol syrup Mannitol Isomalt Maltitol (i) Maltitol (ii) Maltitol syrup Lactitol Xylitol Liqueurs quantum satis (for purposes other than sweetening) Fine bakery wares 3 g/kg Fat emulsions for baking purposes 10 g/kg Milk and cream analogues 5 g/kg Edible ices 1 g/kg Desserts 3 g/kg Sugar confectionery 1 g/kg Emulsified sauces 5 g/kg Soups 1 g/kg Chewing gum 5 g/kg Dietary food supplements quantum satis Dietetic foods intended for special medical purposes – Dietetic formulae for weight control intended to replace total daily food intake or an individual meal 1 g/kg Individually or in combination Flavourings, except liquid smoke flavourings and flavourings based on spice oleoresins (21) 10 g/kg E 432 E 433 E 434 E 435 E 436 Polyoxyethylene sorbitan monolaurate (polysorbate 20) Polyoxyethylene sorbitan monooleate (polysorbate 80) Polyoxyethylene sorbitan monopalmitate (polysorbate 40) Polyoxyethylene sorbitan monostearate (polysorbate 60) Polyoxyethylene sorbitan tristearate (polysorbate 65) Foodstuffs containing liquid smoke flavourings and flavourings based on spice oleoresins 1 g/kg 21 Spice oleoresins are defined as extracts of spices from which the extraction solvent has been evaporated leaving a mixture of the volatile oil and resinous material from the spice. B 613 E No Name Foodstuff Maximum level Cocoa and chocolate products as defined in L.N. 317/2001 including fillings 10 g/kg E 442 Ammonium phosphatides Confectionery based on these products 10 g/kg Non-alcoholic flavoured cloudy drinks 300 mg/l E 444 Sucrose acetate isobutyrate Flavoured cloudy spirit drinks containing less than 15 % alcohol by volume 300 mg/l Non-alcoholic flavoured cloudy drinks 100 mg/l Surface treatment of citrus fruit 50 mg/kg Cloudy spirit drinks in accordance with Council Regulation (EEC) No 1576/89 laying down general rules on the definition, description and presentation of spirit drinks (22) 100 mg/l E 445 Glycerol esters of wood rosins Cloudy spirit drinks containing less than 15 % alcohol by volume 100 mg/l Canned liquid coffee 1 g/l Heat-treated meat products 5 g/kg (on fat) Fat emulsions for baking purposes 10 g/kg Fine bakery wares 10 g/kg Beverage whiteners 20 g/kg Edible ices 5 g/kg Sugar confectionery 5 g/kg Desserts 5 g/kg Sauces 10 g/l Soups and broths 2 g/l Fresh fruits, surface treatment quantum satis E 473 E 474 Sucrose esters of fatty acids Sucroglycerides Non-alcoholic aniseed based drinks 5 g/l 22 OJ L 160,12.6.1989, p.1 B 614 E No Name Foodstuff Maximum level Non-alcoholic coconut and almond drinks 5 g/l Spirituous beverages (excluding wine and beer) 5 g/l Powders for the preparation of hot beverages 10 g/l Dairy-based drinks 5 g/l Dietary food supplements quantum satis Dietetic foods intended for special medical purposes – Dietetic formulae for weight control intended to replace total daily food intake or an individual meal 5 g/kg Chewing gum 10 g/kg Individually or in combination Cream analogues 5 g/kg Sterilised cream and sterilised cream with reduced fat content 5 g/kg Fine bakery wares 10 g/kg Emulsified liqueurs 5 g/l Egg products 1 g/kg Beverage whiteners 0.5 g/kg Chewing gum 5 g/kg Fat emulsions 5 g/kg Milk and cream analogues 5 g/kg Sugar confectionery 2 g/kg Desserts 2 g/kg Dietary food supplements quantum satis Dietetic foods intended for special medical purposes – Dietetic formulae for weight control intended to replace total daily food intake or an individual meal 5 g/kg E 475 Polyglycerol esters of fatty acids Granola-type breakfast cereals 10 g/kg B 615 E No Name Foodstuff Maximum level Spreadable fats as defined in Annexes A, B and C of Regulation (EC) No 2991/94 having a fat content of 41 % or less 4 g/kg Similar spreadable products with a fat content of less than 10 % fat 4 g/kg Dressings 4 g/kg E 476 Polyglycerol polyricinoleate Cocoa-based confectionery, including chocolate 5 g/kg Fine bakery wares 5 g/kg Fat emulsions for baking purposes 10 g/kg Milk and cream analogues 5g/kg Beverage whiteners 1 g/kg Edible ices 3 g/kg Sugar confectionery 5 g/kg Desserts 5 g/kg Whipped dessert toppings other than cream 30 g/kg E 477 Propane-1,2-diol esters of fatty acids Dietetic foods intended for special medical purposes – Dietetic formulae for weight control intended to replace total daily food intake or an individual meal 1 g/kg E 479b Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids Fat emulsions for frying purposes 5 g/kg Fine bakery wares 5 g/kg Quick-cook rice 4 g/kg Breakfast cereals 5 g/kg Emulsified liqueur 8 g/l Spirits with less than 15 % alcohol by volume 8 g/l Cereal-based snacks 2 g/kg Chewing gum 2 g/kg E 481 E 482 Sodium stearoyl-2- lactylate Calcium stearoyl-2- lactylate Fat emulsions 10 g/kg B 616 E No Name Foodstuff Maximum level Desserts 5 g/kg Sugar confectionery 5 g/kg Beverage whiteners 3 g/kg Cereal- and potato-based snacks 5 g/kg Minced and diced canned meat products 4 g/kg Powders for the preparation of hot beverages 2 g/l Dietetic foods intended for special medical purposes – Dietetic formulae for weight control intended to replace total daily food intake or an individual meal 2 g/kg Bread (except that referred to in the Second Schedule) 3 g/kg Mostarda di frutta 2 g/kg Individually or in combination Bakery wares (except breads referred to in the Second Schedule) 4 g/kg E 483 Stearyl tartrate Desserts 5 g/kg Fine bakery wares 10 g/kg Toppings and coatings for fine bakery wares 5 g/kg Jelly marmalade 25 mg/kg (23) Fat emulsions 10 g/kg Milk and cream analogues 5 g/kg Beverage whiteners 5 g/kg Liquid tea concentrates and liquid fruit and herbal infusions concentrates 0.5 g/kg Edible ices 0.5 g/kg Desserts 5 g/kg E 491 E 492 E 493 E 494 E 495 Sorbitan monostearate Sorbitan tristearate Sorbitan monolaurate Sorbitan monooleate Sorbitan monopalmitate Sugar confectionery 5 g/kg 23 E 493 only. B 617 E No Name Foodstuff Maximum level Cocoa-based confectionery, including chocolate 10 g/kg (24) Emulsified sauces 5 g/kg Dietary food supplements quantum satis Yeast for baking quantum satis Chewing gum 5 g/kg Dietetic foods intended for special medical purposes – Dietetic formulae for weight control intended to replace total daily food intake or an individual meal 5 g/kg (pro memoria) For E 491 only, wine in accordance with Regulation (EEC) No 1873/84 authorizing the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79 Individually or in combination E 512 Stannous chloride Canned and bottled white asparagus 25 mg/kg Sn Egg white 30 mg/kg Candied, crystallized and glace fruit and vegetables 200 mg/kg E 520 E 521 E 522 E 523 Aluminium sulphate Aluminium sodium sulphate Aluminium potassium sulphate Aluminium ammonium sulphate Individually or in combination, expressed as aluminium E 541 Sodium aluminium phosphate, acidic Fine bakery wares (scones and sponge wares only) 1 g/kg expressed as aluminium 24 E 492 only. B 618 E No Name Foodstuff Maximum level E 535 E 536 E 538 Sodium ferrocyanide Potassium ferrocyanide Calcium ferrocyanide Salt and its substitutes Individually or in combination, 20 mg/kg as anhydrous potassium ferrocyanide E 551 Silicon dioxide Flavourings 50 g/kg Dried powdered foodstuffs (including sugars) 10 g/kg Salt and its substitutes 10 g/kg Dietary food supplements quantum satis Foodstuffs in tablet and coated tablet form quantum satis Sliced or grated hard, semi-hard and processed cheese 10 g/kg Sliced or grated cheese analogues and processed cheese analogues 10 g/kg Chewing gum quantum satis (26) Rice quantum satis (26) Sausages (surface treatment only) quantum satis (26) Seasonings 30 g/kg Confectionery excluding chocolate (surface treatment only) quantum satis (26) E 551 E 552 E 553a E 553b E 554 E 555 E 556 E 559 Silicon dioxide Calcium silicate i) Magnesium silicate ii) Magnesium trisilicate (25) Talc Sodium aluminium silicate Potassium aluminium silicate Calcium aluminium silicate Aluminium silicate (Kaolin) Tin-greasing products 30 g/kg E 579 E 585 Ferrous gluconate Ferrous lactate Olives darkened by oxidation 150 mg/kg as Fe Foodstuffs in general (except those referred to in regulation 4.3.1) 10 g/kg Individually or in combination E 620 E 621 E 622 E 623 E 624 E 625 Glutamic acid Monosodium glutamate Monopotassium glutamate Calcium diglutamate Monoammonium glutamate Magnesium diglutamate Condiments and seasonings quantum satis E 626 E 627 E 628 E 629 E 630 Guanylic acid Disodium guanylate Dipotassium guanylate Calcium guanylate Inosinic acid Foodstuffs in general (except those referred to in regulation 4.3.1) 500 mg/kg Individually or in combination, expressed as guanylic acid 25 Asbestos free. 26 E 553b only. B 619 E No Name Foodstuff Maximum level E 631 E 632 E 633 E 634 E 635 Disodium inosinate Dipotassium inosinate Calcium inosinate Calcium 5’-ribonucleotides Disodium 5’ ribonucleotides Seasonings and condiments quantum satis Jam, jellies and marmalades as defined in L.N. 79/1999 and similar fruit spreads, including low calorie products 10 mg/kg Soups and broths 10 mg/kg Oils and fats for frying 10 mg/kg Confectionery (excluding chocolate) 10 mg/kg Non-alcoholic flavoured drinks 10 mg/l Pineapple juice 10 mg/l Canned and bottled fruit and vegetables 10 mg/kg Chewing gum 100 mg/kg (pro memoria) For E 491 only, wine in accordance with Regulation (EEC) No 1873/84 authorizing the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79 Sød…Saft 10 mg/l Batters 10 mg/kg Cider excluding cidre bouché 10 mg/l E 900 Dimethyl polysiloxane Flavourings 10 mg/kg B 620 E No Name Foodstuff Maximum level As glazing agents only for: confectionery (including chocolate) small products of fine bakery wares coated with chocolate snacks nuts coffee beans quantum satis Dietary food supplements quantum satis Fresh citrus fruits, melons, apples and pears (surface treatment only) quantum satis E 901 E 902 E 904 Beeswax, white and yellow Candelilla wax Shellac Peaches and pineapples (surface treatment only) quantum satis As glazing agents only: confectionery (including chocolate) 500 mg/kg 1200 mg/kg (only for chewing gum) small products of fine bakery wares coated with chocolate 200 mg/kg snacks 200 mg/kg nuts 200 mg/kg coffee beans 200 mg/kg dietary food supplements 200 mg/kg E 903 Carnauba wax fresh citrus fruits, melons, apples, pears, peaches and pineapples (surface treatment only) 200 mg/kg E 905 Microcrystalline wax Surface treatment of: confectionery excluding chocolate chewing gum melons, papaya, mango and avocado quantum satis Fresh citrus fruits (surface treatment only) quantum satis E 912 E 914 Montan acid esters Oxidised polyethylene wax Fresh melon, mango, papaya, avocado and pineapple (surface treatment only) quantum satis B 621 E No Name Foodstuff Maximum level E 927b Carbamide Chewing gum without added sugars 30 g/kg Chewing gum with added sugars 800 mg/kg (as flavour enhancer only) 27 Water-based flavoured non-alcoholic drinks 0.5 mg/l E 950 Acesulfame-K Desserts – dairy and non dairy 5 mg/kg (as flavour enhancer only) Chewing gum with added sugars 2500 mg/kg (as flavour enhancer only) 27 Water-based flavoured non-alcoholic drinks 0.5 mg/l E 951 Aspartame Desserts – dairy and non dairy 5 mg/kg (as flavour enhancer only) Chewing gum with added sugars 10 mg/kg (as flavour enhancer only) 27 Water-based flavoured non-alcoholic drinks 0.5 mg/l E 957 Thaumatin Desserts – dairy and non dairy 5 mg/kg (as flavour enhancer only) Chewing gum with added sugars 150 mg/kg Spreadable fats as defined in Annexes B and C of Regulation (EC) No 2991/94 5 mg/kg 27 E 959 Neohesperidine DC Meat products Fruit jellies Vegetable proteins 5 mg/kg (as flavour enhancer only) 27 Water-based flavoured non-alcoholic drinks 200 mg/l calculated as anhydrous extract E 999 Quillaia extract Cider excluding cidre bouché 200 mg/l calculated as anhydrous extract 27 If E 950, E 951, E 957 and E 959 are used in combination in chewing gum, the maximum level for each is reduced proportionally. B 622 E No Name Foodstuff Maximum level E 1201 E 1202 Polyvinylpyrolidone Polyvinylpolypyrolidone Dietary food supplements in tablet and coated tablet form quantum satis E 1505 Triethyl citrate Dried egg white quantum satis E 1518 Glyceryl triacetate (triacetin) Chewing gum quantum satis Foodstuffs in tablet and coated tablet form quantum satis Encapsulated flavourings in flavoured teas and flavoured powdered instant drinks 500 mg/kg E 459 Beta-cyclodextrine flavoured snacks 1 g/kg in foodstuffs as consumed or as reconstituted according to the instructions of the manufacturer E 425 Konjac (28) i) Konjac gum ii) Konjac glucomannane Foodstuffs in general (except those referred to in paragraph 4.3 and jelly confectionery including jelly-mini-cups) 10 g/kg individually or in combination E 650 Zinc acetate Chewing gum 1000 mg/kg Vegetable oil pan spray (for professional use only) quantum satis E 943a E 943b E 944 Butane Isobutane Propane Water-based emulsion spray quantum satis As glazing agent for sugar confectionery 2 g/kg E 907 Hydrogenated poly-1 decene dried fruits 2 g/kg E 1505 Triethyl citrate E 1517 Glyceryl diacetate (diacetin) E 1518 Glyceryl triacetate (triacetin) Flavourings 3 g/kg from all sources in foodstuffs as consumed or as 28 These substances may not be used to produce dehydrated foodstuffs intended to rehydrate on ingestion. B 623 E No Name Foodstuff Maximum level E 1520 Propan-1,2-diol (propylene glycol) reconstituted according to the instructions of the manufacturer; individually or in combination. In the case of beverages, the maximum level of E 1520 shall be 1 g/l Flavourings for liqueurs, aromatised wines, aromatised wine based drinks and aromatised wine-products cocktails 100 mg/l E 1519 Benzyl alcohol confectionery including chocolate and fine bakery wares 250 mg/kg from all sources in foodstuffs as consumed or as reconstituted according to the instructions of the manufacturer B 624 FIFTH SCHEDULE Permitted Carriers and Carrier Solvents Note: Not included in this list are: 1. Substances generally considered as foodstuffs; 2. Substances referred to in regulation 4.3; 3. Substances having primarily an acid or acidity regulator function, such as citric acid and ammonium hydroxide. E No Name Restricted Use E 1520 Propane-1,2-diol (propylene glycol) Colours, emulsifiers, antioxidants and enzymes (maximum 1 g/kg in the foodstuff) E 422 E 420 E 421 E 953 E 965 E 966 E 967 Glycerol Sorbitol Mannitol Isomalt Maltitol Lactitol Xylitol E 400 – 404 Alginic acid and its sodium, potassium, calcium and ammonium salts E 405 E 406 E 407 E 410 E 412 E 413 E 414 E 415 E 440 Propan-1,2-diol alginate Agar Carrageenan Locust bean gum Guar gum Tragacanth Acacia gum (gum arabic) Xanthan gum Pectins E 432 E 433 E 434 E 435 E 436 Polyoxyethylene sorbitan monolaurate (polysorbate 20) Polyoxyethylene sorbitan monooleate (polysorbate 80) Polyoxyethylene sorbitan monopalmitate (polysorbate 40) Polyoxyethylene sorbitan monostearate (polysorbate 60) Polyoxyethylene sorbitan tristearate (polysorbate 65) Antifoaming agents B 625 E No Name Restricted Use E 442 Ammonium phosphatides Antioxidants E 460 Cellulose (microcrystalline or powdered) Methyl cellulose Hydroxypropyl cellulose Hydroxypropyl methyl cellulose Ethyl methyl cellulose Carboxy methyl cellulose Sodium carboxy methyl cellulose E 322 E 432 – 436 E 470b E 471 E 472a E 472c E 472e E 473 E 475 Lecithins Polysorbates 20, 40, 60, 65 and 80 Magnesium salts of fatty acids Mono- and diglycerides of fatty acids Acetic acid esters of mono- and diglycerides of fatty acids Citric acid esters of mono- and diglycerides of fatty acids Mono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids Sucrose esters of fatty acids Polyglycerol esters of fatty acids Colours and fat-soluble antioxidants E 491 E 492 E 493 E 494 E 495 Sorbitan monostearate Sorbitan tristearate Sorbitan monolaurate Sorbitan monooleate Sorbitan monopalmitate Colours and anti- foaming agents E 1404 E 1410 E 1412 E 1413 E 1414 E 1420 E 1422 E 1440 E 1442 E 1450 Oxidised starch Monostarch phosphate Distarch phosphate Phosphated distarch phosphate Acetylated distarch phosphate Acetylated starch Acetylated distarch adipate Hydroxy propyl starch Hydroxy propyl distarch phosphate Starch sodium octenyl succinate E 170 E 263 E 331 E 332 E 341 E 501 E 504 E 508 E 509 Calcium carbonates Calcium acetate Sodium citrates Potassium citrates Calcium phosphates Potassium carbonates Magnesium carbonates Potassium chloride Calcium chloride B 626 E No Name Restricted Use E 511 E 514 E 515 E 516 E 517 Magnesium chloride Sodium sulphate Potassium sulphate Calcium sulphate Ammonium sulphate E 577 E 640 E 1505 E 1518 Potassium gluconate Glycine and its sodium salt Triethyl citrate Glyceryl triacetate (triacetin) E 551 E 552 Silicon dioxide Calcium silicate Emulsifiers and colours, max. 5 % E 553b E 558 E 559 Talc Bentonite Aluminium silicate (Kaolin) Colours, max. 5 % E 901 Beeswax Colours E 1200 Polidextrose E 1201 E 1202 Polyvinylpyrrolidone Polyvinylpolypyrrolidone Sweeteners E 322 E 432 436 E 470a E 471 E 491 495 E 570 E 900 Lecithins Polysorbates Sodium, potassium and calcium salts of fatty acids Mono- and diglycerides of fatty acids Sorbitans Fatty acids Dimethylpolysiloxane Glazing agents for fruit Polyethyleneglycol 6000 Sweeteners E 425 Konjac i) Konjac-gum ii) Konjac-glucomannane E 459 Beta-cyclodextrine 1 g/kg E 1451 Acetylated oxidized starch E 468 Cross linked sodium carboxy methyl cellulose Cross-linked cellulose gum Sweeteners E 469 Enzymatically hydrolysed carboxy methyl cellulose E 555 Potassium aluminium silicate In E 171 titanium dioxide and E 172 iron oxides and hydroxides (max 90 % relative to the pigment) B 627 SIXTH SCHEDULE Food Additives Permitted in Foods for Infants and Young Children Note: Formulae and weaning foods for infants and young children may contain E 414 (acacia gum, gum arabic) and E 551 (silicon dioxide) resulting from the addition of nutrient preparations containing not more than 150 g/kg of E 414 and 10 g/kg of E 551, as well as E 421 (mannitol) when used as a carrier for vitamin B12 (not less than one part vitamin B12 to 1 000 parts mannitol). The carry over of E 414 in the product ready for consumption should not be more than 10 mg/kg. Formulae and weaning foods for infants and young children may contain E 1450 starch sodium octenyl succinate resulting from the addition of vitamin preparations or polyunsaturated fatty acid preparations. The carry over of E 1450 in the product ready for consumption is not to be more than 100 mg/kg from vitamin preparations and 1000 mg/kg from polyunsaturated fatty acid preparations. Formulae and weaning foods for infants and young children may contain E 301 (sodium L-ascorbate), used at QS level in coatings of nutrient preparations containing polyunsaturated fatty acids. The carry over of E 301 in the product ready for consumption should not be more than 75 mg/l. The maximum levels of use indicated refer to foodstuffs ready for consumption prepared following manufacturers' instructions. B 628 PART 1 Food Additives Permitted in Infant Formulae for Infants in Good Health Notes: 1. For the manufacture of acidified milks, non-pathogenic L(+)- lactic acid producing cultures may be used. 2. If more than one of the substances E 322, E 471, E 472c and E 473 are added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is present of the other substances together in that foodstuff. E No Name Maximum level E 270 E 330 E 338 Lactic acid (L(+)-form only) Citric acid Phosphoric acid quantum satis quantum satis In conformity with the limits set in the First Schedule to L.N. 208/2002 E 306 E 307 E 308 E 309 Tocopherol-rich extract Alpha-tocopherol Gamma-tocopherol Delta-tocopherol 10 mg/l Individually or in combination E 322 E 471 E 304 Lecithins Mono- and diglycerides L-ascorbyl palmitate 1 g/l 4 g/l 10 mg/l E 331 E 332 Sodium citrates Potassium citrates 2 g/l Individually or in combination and in conformity with the limits set by the First Schedule to L.N. 208/2002 E 339 E 340 Sodium phosphates Potassium phosphates 1 g/l expressed as P2O5 Individually or in combination and in conformity with the limits set by the First Schedule to L.N. 208/2002 E 412 Guar gum 1 g/l, where the liquid product contains partially hydrolysed proteins and is in conformity with the conditions set in the Fourth Schedule to L.N. 208/2002 E 472c Citric acid esters of mono- and diglycerides of fatty acids 7.5 g/l sold as powder 9 g/l sold as liquid where the products contain partially hydrolysed proteins, peptides or amino acids and are in conformity with the conditions set in the Fourth Schedule to L.N. 208/2002 E 473 Sucrose esters of fatty acids 120 mg/l in products containing hydrolysed proteins, peptides or amino B 629 E No Name Maximum level acids B 630 PART 2 FOOD ADDITIVES PERMITTED IN FOLLOW-ON FORMULAE FOR INFANTS IN GOOD HEALTH Note 1. For the manufacture of acidified milks, non-pathogenic L(+)- lactic acid producing cultures may be used. 2. If more than one of the substances E 322, E 471, E 472c and E 473 is added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is present of the other substances together in that foodstuff. 3. If more than one of the substances E 407, E 410 and E 412 is added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is present of the other substances together in that foodstuff. E No Name Maximum level E 270 E 330 Lactic acid (L(+)-form only) Citric acid quantum satis quantum satis E 306 E 307 E 308 E 309 Tocopherol-rich extract Alpha-tocopherol Gamma-tocopherol Delta-tocopherol 10 mg/l individually or in combination E 338 Phosphoric acid In conformity with the limits set in the Second Schedule to L.N. 208/2002 E 440 Pectins 5 g/l in acidified follow-on formulae only E 322 E 471 Lecithins Mono- and diglycerides 1 g/l 4 g/l E 407 E 410 E 412 Carrageenan Locust bean gum Guar gum 0.3 g/l 1 g/l 1 g/l E 304 L-ascorbyl palmitate 10 mg/l E 331 E 332 Sodium citrates Potassium citrates 2 g/l Individually or in combination and in conformity with the limits set by the First Schedule to L.N. 208/2002 E 339 E 340 Sodium phosphates Potassium phosphates 1 g/l expressed as P2O5 Individually or in combination and in conformity with the limits set by the First Schedule to L.N. 208/2002 E 472c Citric acid esters of mono- and diglycerides of fatty acids 7.5 g/l sold as powder 9 g/l sold as liquid where the products B 631 E No Name Maximum level contain partially hydrolysed proteins, peptides or amino acids and are in conformity with the conditions set in the Fourth Schedule of L.N. 208/2002 E 473 Sucrose esters of fatty acids 120 mg/l in products containing hydrolysed proteins, peptides or amino acids B 632 PART 3 Food Additives permitted in Weaning Foods for Infants and Young Children in Good Health E No Name Foodstuff Maximum level E 170 E 260 E 261 E 262 E 263 E 270 E 296 E 325 E 326 E 327 E 330 E 331 E 332 E 333 E 507 E 524 E 525 E 526 Calcium carbonates Acetic acid Potassium acetate Sodium acetates Calcium acetate Lactic acid (1) Malic acid (1) Sodium lactate (1) Potassium lactate (1) Calcium lactate (1) Citric acid Sodium citrates Potassium citrates Calcium citrates Hydrochloric acid Sodium hydroxide Potassium hydroxide Calcium hydroxide Weaning foods quantum satis (only for pH adjustment) E 500 E 501 E 503 Sodium carbonates Potassium carbonates Ammonium carbonates Weaning foods quantum satis (only as raising agents) Individually or in combination, expressed as ascorbic acid Fruit- and vegetable-based drinks, juices and baby foods 0.3 g/kg E 300 E 301 E 302 L-ascorbic acid Sodium L-ascorbate Calcium L-asorbate Fat-containing cereal-based foods including biscuits and rusks 0.2 g/kg E 304 E 306 E 307 E 308 E 309 L-ascorbyl palmitate Tocopherol-rich extract Alpha-tocopherol Gamma-tocopherol Delta-tocopherol Fat-containing cereals, biscuits, rusks and baby foods 0.1 g/kg individually or in combination 1 L(+)-form only. B 633 E No Name Foodstuff Maximum level E 338 Phosphoric acid Weaning foods 1 g/kg as P2O5 E 339 E 340 E 341 Sodium phosphates Potassium phosphates Calcium phosphates Cereals 1 g/kg individually or in combination, expressed as P2O5 Biscuits and rusks Cereal-based foods E 322 Lecithins Baby foods 10 g/kg Biscuits and rusks Cereal-based foods E 471 E 472a E 472b E 472c Mono- and diglycerides of fatty acids Acetic acid esters of mono- and diglycerides of fatty acids Lactic acid esters of mono- and diglycerides of fatty acids Citric acid esters of mono- and diglycerides of fatty acids Baby foods 5 g/kg individually or in combination Desserts E 400 E 401 E 402 E 404 Alginic acid Sodium alginate Potassium alginate Calcium alginate Puddings 0.5 g/kg individually or in combination Weaning foods 10 g/kg individually or in combination E 410 E 412 E 414 E 415 E 440 Locust bean gum Guar gum Acacia gum (gum arabic) Xanthan gum Pectins Gluten-free cereal based foods 20 g/kg individually or in combination E 551 Silicon dioxide Dry cereals 2 g/kg E 334 E 335 E 336 E 354 E 450a E 575 Tartaric acid (2) Sodium tartrate (2) Potassium tartrate (2) Calcium tartrate (2) Disodium diphosphate Glucono-delta-lactone Biscuits and rusks 5 g/kg as a residue E 1404 E 1410 E 1412 E 1413 E 1414 E 1420 E 1422 E 1450 Oxidized starch Monostarch phosphate Distarch phosphate Phosphated distarch phosphate Acetylated distarch phosphate Acetylated starch Acetylated distarch adipate Starch sodium octenyl succinate Weaning foods 50 g/kg E 333 Calcium citrates (3) In low-sugar fruit based products quantum satis 2 L(+)-form only. 3 The note in Part IV does not apply. B 634 E No Name Foodstuff Maximum level E 341 Tricalcium phosphate (3) In fruit-based desserts 1 g/kg as P2O5 E 1451 Acetylated oxidized starch Weaning foods 50 g/kg I I B 635 PART 4 Food Additives permitted in Dietary Foods for Infants and Young Children for Special Medical Purposes as defined in L.N. 309/2001 The tables in Parts 1 to 3 of the Sixth Schedule are applicable. E No Name Maximum level Special conditions E 401 Sodium alginate 1 g/l From four months onwards in special food products with adapted composition, required for metabolic disorders and for general tube-feeding E 405 Propane-1,2-diol alginate 200 mg/l From 12 months onwards in specialised diets intended for young children who have cow’s milk intolerance or inborn errors of metabolism E 410 Locust bean gum 10 g/l From birth onwards in products for reduction of gastro oesophageal reflux E 412 Guar gum 10 g/l From birth onwards in products in liquid formulae containing hydrolysed proteins, peptides or amino acids in conformity with the conditions set in the Fourth Schedule to L.N. 208/2002. E 415 Xanthan gum 1.2 g/l From birth onwards for use in products based on amino acids or peptides intended for patients who have problems with impairment of the gastro intestinal tract, protein malabsorption or inborn errors of metabolism E 440 Pectins 10 g/l From birth onwards in products used in case of gastro- intestinal disorders E 466 Sodium carboxy methyl cellulose 10 g/l or kg From birth onwards in products for the dietary management of metabolic disorders E 471 Mono- and diglycerides of fatty acids 5 g/l From birth onwards in specialised diets, particularly those devoid of proteins E 1450 Starch sodium octenyl succinate 20 g/l In infant formulae and follow on formulae B 636 E No Name Maximum level Special conditions 7.5 g/l sold as powder E 472c Citric acid esters of mono- and diglycerides of fatty acids 9 g/l sold as liquid From birth onwards B 637 SEVENTH SCHEDULE Purity Criteria Purity criteria for the following additives are prescribed in Council Directive 96/77/EC (Off. J. European Communities 1996, 39 (L339), 1-69): E 200 Sorbic acid E 202 Potassium sorbate E 203 Calcium sorbate E 210 Benzoic acid E 211 Sodium benzoate E 212 Potassium benzoate E 213 Calcium benzoate E 214 Ethyl p-hydroxybenzoate E 215 Sodium ethyl p-hydroxybenzoate E 216 Propyl p-hydroxybenzoate E 217 Sodium propyl p-hydroxybenzoate E 218 Methyl p-hydroxybenzoate E 219 Sodium methyl p-hydroxybenzoate E 220 Sulphur dioxide E 221 Sodium sulphite E 222 Sodium hydrogen sulphite E 223 Sodium metabisulphite E 224 Potassium metabisulphite E 226 Calcium sulphite E 227 Calcium hydrogen sulphite E 228 Potassium hydrogen sulphite E 230 Biphenyl E 231 Orthophenyl phenol E 232 Sodium orthophenyl phenol E 233 Thiabendazole E 234 Nisin E 235 Natamycin E 239 Hexamethylene tetramine E 242 Dimethyl dicarbonate E 249 Potassium nitrite E 250 Sodium nitrite E 252 Potassium nitrate E 260 Acetic acid E 261 Potassium acetate E 262 Sodium acetates (i) sodium acetate (ii) sodium hydrogen acetate (sodium diacetate) E 263 Calcium acetate E 270 Lactic acid B 638 E 280 Propionic acid E 281 Sodium propionate E 282 Calcium propionate E 283 Potassium propionate E 284 Boric acid E 285 Sodium tetraborate (borax) E 290 Carbon dioxide E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 304 Fatty acid esters of ascorbic acid (i) ascorbyl palmitate (ii) ascorbyl stearate E 306 Tocopherol-rich extract E 307 Alpha-tocopherol E 308 Gamma-tocopherol E 309 Delta-tocopherol E 310 Propyl gallate E 311 Octyl gallate E 312 Dodecyl gallate E 315 Erythorbic acid E 316 Sodium erythorbate E 320 Butylated hydroxyanisole (BHA) E 321 Butylated hydroxytoluene (BHT) E 322 Lecithins E 325 Sodium lactate E 326 Potassium lactate E 327 Calcium lactate E 330 Citric acid E 331 Sodium citrates (i) monosodium citrate (ii) disodium citrate (iii) trisodium citrate E 332 Potassium citrates (i) monopotassium citrate (ii) tripotassium citrate E 333 Calcium citrates (i) monocalcium citrate (ii) dicalcium citrate (iii) tricalcium citrate E 334 Tartaric acid (L(+)-) E 335 Sodium tartrates (i) monosodium tartrate (ii) disodium tartrate E 336 Potassium tartrates (i) monopotassium tartrate B 639 (ii) dipotassium tartrate E 337 Sodium potassium tartrate E 338 Phosphoric acid E 339 Sodium phosphates (i) monosodium phosphate (ii) disodium phosphate (iii) trisodium phosphate E 340 Potassium phosphates (i) monopotassium phosphate (ii) dipotassium phosphate (iii) tripotassium phosphate E 341 Calcium phosphates (i) monocalcium phosphate (ii) dicalcium phosphate (iii) tricalcium phospha te E 385 Calcium disodium ethylene diamine tetra-acetate (Calcium disodium EDTA) E 1105 Lysozyme Purity criteria for the following are established by amending Council Directive 98/86/EC (Off. J. European Communities 1998, 41 (L334), 1-63): E 400 Alginic acid E 401 Sodium alginate E 402 Potassium alginate E 403 Ammonium alginate E 404 Calcium alginate E 405 Propane-1,2-diol alginate E 406 Agar E 410 Locust bean gum E 412 Guar gum E 413 Tragacanth E 414 Acacia gum E 415 Xanthan gum E 416 Karaya gum E 417 Tara gum E 418 Gellan gum E 422 Glycerol E 440 Pectins (i) pectin (ii) amidated pectin E 442 Ammonium phosphatides E 444 Sucrose acetate isobutyrate E 445 Glycerol esters of wood rosins E 450 Diphosphates (i) disodium diphosphate (ii) trisodium diphosphate B 640 (iii) tetrasodium diphosphate (iv) tetrapotassium diphosphate (v) dicalcium diphosphate (vi) calcium dihydrogen diphosphate E 451 Triphosphates (i) pentasodium triphosphate (ii) pentapotassium triphosphate E 452 Polyphosphates (i) sodium polyphosphate (ii) potassium polyphosphate (iii) calcium polyphosphates E 460 Cellulose (i) microcrystalline cellulose (ii) powdered cellulose E 461 Methyl cellulose E 463 Hydroxypropyl cellulose E 464 Hydroxypropyl methyl cellulose E 465 Ethyl methyl cellulose E 466 (Sodium) carboxy methyl cellulose E 470a Sodium, potassium and calcium salts of fatty acids E 470b Magnesium salts of fatty acids E 471 Mono- and diglycerides of fatty acids E 472a Acetic acid esters of mono- and diglycerides of fatty acids E 472b Lactic acid esters of mono- and diglycerides of fatty acids E 472c Citric acid esters of mono- and diglycerides of fatty acids E 472d Tartaric acid esters of mono- and diglycerides of fatty acids E 472e Mono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids E 472f Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids E 473 Sucrose esters of fatty acids E 474 Sucroglycerides E 475 Polyglycerol esters of fatty acids E 476 Polyglycerol polyricinoleate E 477 Propane-1,2-diol esters of fatty acids E 479b Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids E 481 Sodium stearoyl-2- lactylate E 482 Calcium stearoyl-2- lactylate E 483 Stearyl tartrate E 491 Sorbitan monostearate E 492 Sorbitan tristearate E 493 Sorbitan monolaurate E 494 Sorbitan monooleate E 495 Sorbitan monopalmitate E 508 Potassium chloride E 579 Ferrous gluconate E 585 Ferrous lactate B 641 Purity criteria for the following are established by amending Council Directive 2000/63/EC (Off. J. European Communities 2000, 43 (L277), 1-61): E 320 Butylated hydroxyanisole (BHA) E 296 Malic acid E 297 Fumaric acid E 343(i) Monomagnesium phosphate E 343(ii) Dimagnesium phosphate E 350(i) Sodium malate E 350(ii) Sodium hydrogen malate E 351 Potassium malate E 352(i) Calcium malate E 352(ii) Calcium hydrogen malate E 355 Adipic acid E 363 Succinic acid E 380 Triammonium citrate E 452(iii) Sodium calcium polyphosphate E 468 Cross-linked sodium carboxymethylcellulose E 469 Enzymatically hydrolysed carboxymethylcellulose E 500(i) Sodium carbonate E 500(ii) Sodium hydrogen carbonate E 500(iii) Sodium sesquicarbonate E 501(i) Potassium carbonate E 501(ii) Potassium hydrogen carbonate E 503(i) Ammonium carbonate E 503(ii) Ammonium hydrogen carbonate E 507 Hydrochloric acid E 509 Calcium chloride E 511 Magnesium chloride E 512 Stannous chloride E 513 Sulphuric acid E 514(i) Sodium sulphate E 514(ii) Sodium hydrogen sulphate E 515(i) Potassium sulphate E 515(ii) Potassium hydrogen sulphate E 516 Calcium sulphate E 517 Ammonium sulphate E 520 Aluminium sulphate E 512 Aluminium sodium sulphate E 522 Aluminium potassium sulphate E 523 Aluminium ammonium sulphate E 524 Sodium hydroxide E 525 Potassium hydroxide E 526 Calcium hydroxide E 527 Ammonium hydroxide B 642 E 528 Magnesium hydroxide E 529 Calcium oxide E 530 Magnesium oxide E 535 Sodium ferrocyanide E 536 Potassium ferrocyanide E 538 Calcium ferrocyanide E 541 Sodium aluminium phosphate, acidic E 551 Silicon dioxide E 552 Calcium silicate E 553a(i) Magnesium silicate E 553a(ii) Magnesium trisilicate E 570 Fatty acids E 574 Gluconic acid E 575 Glucono-delta-lactone E 576 Sodium gluconate E 577 Potassium gluconate E 578 Calcium gluconate E 640 Glycine and its sodium salt E 900 Dimethyl polysiloxane E 901 Beeswax E 902 Candelilla wax E 903 Carnauba wax E 904 Shellac E 920 L-cysteine E 927b Carbamide E 938 Argon E 939 Helium E 941 Nitrogen E 942 Nitrous oxide E 948 Oxygen E 999 Quillaia extract E 1103 Invertase E 1200 Polydextrose E 1404 Oxidised starch E 1410 Monostarch phosphate E 1412 Distarch phosphate E 1413 Phosphated distarch phosphate E 1414 Acetylated distarch phosphate E 1420 Acetylated starch E 1422 Acetylated distarch adipate E 1440 Hydroxypropyl starch E 1442 Hydroxypropyl distarch phosphate E 1450 Starch sodium octenyl succinate E 1451 Acetylated oxidised starch E 1505 Triethyl citrate E 1518 Glyceryl triacetate B 643 E 1520 Propane-1,2-diol Purity criteria for the following are established by amending Commission Directive 2001/30/EC (Off. J. European Communities 2001, (L146), 1-23): E 170 (i) Calcium carbonate E 353 Metatartaric acid E 354 Calcium tartrate E 356 Sodium adipate E 357 Potassium adipate E 420 (i) Sorbitol E 420 (ii) Sorbitol syrup E 421 Mannitol E 425 (i) Konjac gum E 425 (ii) Konjac glucomannan E 504 (ii) Magnesium hydroxide carbonate E 553b Talc E 554 Sodium aluminium silicate E 555 Potassium aluminium silicate E 556 Calcium aluminium silicate E 558 Bentonite E 559 Aluminium silicate (Kaolin) E 620 Glutamic acid E 621 Monosodium glutamate E 622 Monopotassium glutamate E 623 Calcium diglutamate E 624 Monoammonium glutamate E 625 Magnesium diglutamate E 626 Guanylic acid E 627 Disodium guanylate E 628 Dipotassium guanylate E 629 Calcium guanylate E 630 Inosinic acid E 631 Disodium inosinate E 632 Dipotassium inosinate E 633 Calcium inosinate E 634 Calcium 5’-ribonucleotide E 635 Disodium 5’-ribonucleotide E 905 Microcrystalline wax E 912 Montan acid esters E 914 Oxidised polyethylene wax E 950 Acesulfame K E 951 Aspartame E 953 Isomalt E 957 Thaumatin E 959 Neohesperidine dihydrochalcone B 644 E 965 (i) Maltitol E 965 (ii) Maltitol syrup E 966 Lactitol E 967 Xylitol Purity criteria for the following are established by amending Commission Directive 2002/82/EC (Off. J. European Communities 2002, (L292), 1-28): E 338 Phosphoric acid E 339(i) Monosodium phosphate E 339(ii) Disodium phosphate E 339(iii) Trisodium phosphate E 340(i) Monopotassium phosphate E 340(ii) Dipotassium phosphate E 340(iii) Tripotassium phosphate E 341(i) Monocalcium phosphate E 341(ii) Dicalcium phosphate E 341(iii) Tricalcium phosphate E 450(i) Disodium diphosphate E 450(ii) Trisodium diphosphate E 450(iii) Tetrasodium diphosphate E 450(v) Tetrapotassium diphosphate E 450(vi) Dicalcium diphosphate E 450(vii) Calcium dihydrogen diphosphate E 451(i) Pentasodium triphosphate E 451(ii) Pentapotassium triphosphate E 452(i) Sodium polyphosphate E 452(ii) Potassium polyphosphate E 452(iv) Calcium polyphosphate E 650 Zinc acetate E 943a Butane E 943b Isobutane E 944 Propane E 949 Hydrogen E 1201 Polyvinylpyrrolidone E 1202 Polyvinylpolypyrrolidone Purity criteria for the following are established by Commission Directive 2003/95/EC (Off. J. European Communities 2003, (L 283), 71-77): E 251 Sodium nitrate E 431 Polyoxyethylene (40) stearate E 432 Polyoxyethylene sorbitan monolaurate (polysorbate 20) E 433 Polyoxyethylene sorbitan monooleate (polysorbate 80) E 434 Polyoxyethylene sorbitan monopalmitate (polysorbate 40) E 435 Polyoxyethylene sorbitan monostearate (polysorbate 60) B 645 E 436 Polyoxyethylene sorbitan tristearate (polysorbate 65) E 459 Beta-cyclodextrin Polyethylene glycol 6000 Purity criteria for the following are established by Commission Directive 2004/45/EC (Off. J. European Communities 2004, (L 113), 19-23): E 407 Carrageenan E 407a Processed eucheuma seaweed E 907 Hydrogenated poly-1-decene E 1517 Glyceryl diacetate E 1519 Benzyl alcohol