Commission Regulation (EU) No 1130/2011 of 11 November 2011 amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives by establishing a Union list of food additives approved for use in food additives, food enzymes, food flavourings and nutrients Text with EEA relevance

Amendment to Regulation (EC) No 1333/2008

Article 1

Annex III to Regulation (EC) No 1333/2008 is replaced by the text of the Annex to this Regulation.

Transitional measures

Article 2

Preparations not complying with Parts 2, 3 and/or Section A of Part 5 of Annex III to Regulation (EC) No 1333/2008, as amended by this Regulation, may continue to be placed on the market in accordance with national provisions during a period of 24 months from the date of entry into force of this Regulation. Foods containing such preparations that have been lawfully placed on the market within that period may be marketed until stocks are exhausted. Preparations not complying with Parts 1 and 4 of Annex III to Regulation (EC) No 1333/2008, as amended by this Regulation, may continue to be placed on the market in accordance with the provisions of Annexes I to VI to Directive 95/2/EC until 31 May 2013. Foods containing such preparations that have been lawfully placed on the market within that period may be marketed until stocks are exhausted.

Entry into force

Article 3

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union . It shall apply from 2 December 2011.

ANNEXSupplementary provisions

ANNEX ‘ANNEX III Union list of food additives including carriers approved for use in food additives, food enzymes, food flavourings, nutrients and their conditions of use Definitions 1. “nutrients” for the purposes of this Annex means vitamins, minerals and other substances added for nutritional purposes, as well as substances added for physiological purposes as covered by Regulation (EC) No 1925/2006, Directive 2002/46/EC, Directive 2009/39/EC and Regulation (EC) No 953/2009. 2. “preparation” for the purposes of this Annex means a formulation consisting of one or more food additives, food enzymes and/or nutrients in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardisation, dilution or dissolution. PART 1 Carriers in food additives E number of the carrier Name of the carrier Maximum level Food additives to which the carrier may be added E 1520 Propane-1, 2-diol (propylene glycol) 1 000  mg/kg in final food (as carry-over)  ( *1 ) Colours, emulsifiers and antioxidants E 422 Glycerol quantum satis All food additives E 420 Sorbitol E 421 Mannitol E 953 Isomalt E 965 Maltitol E 966 Lactitol E 967 Xylitol E 968 Erythritol E 400 – E 404 Alginic acid – alginates (Table 7 of Part 6) E 405 Propane-1, 2-diol alginate E 406 Agar E 407 Carrageenan E 410 Locust bean gum E 412 Guar gum E 413 Tragacanth E 414 Gum arabic (acacia gum) E 415 Xanthan gum E 440 Pectins E 432 – E 436 Polysorbates (Table 4 of Part 6) quantum satis Antifoaming agents E 442 Ammoniumphosphatides quantum satis Antioxidants E 460 Cellulose quantum satis All food additives E 461 Methyl cellulose E 462 Ethyl 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 322 Lecithins quantum satis Colours and fat-soluble antioxidants E 432 – E 436 Polysorbates (Table 4 of Part 6) 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 472c Citric 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 473 Sucrose esters of fatty acids E 475 Polyglycerol esters of fatty acids E 491 – E 495 Sorbitan esters (Table 5 of Part 6) quantum satis Colours and antifoaming agents E 1404 Oxidised starch quantum satis All food additives 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 E 170 Calcium carbonate E 263 Calcium acetate E 331 Sodium citrates E 332 Potassium citrates E 341 Calcium phosphates E 501 Potassium carbonates E 504 Magnesium carbonates E 508 Potassium chloride E 509 Calcium chloride E 511 Magnesium chloride E 514 Sodium sulphates E 515 Potassium sulphates E 516 Calcium sulphate E 517 Ammonium sulphate E 577 Potassium gluconate E 640 Glycine and its sodium salt E 1505  ( *1 ) Triethyl citrate E 1518  ( *1 ) Glyceryl triacetate (triacetin) E 551 Silicon dioxide quantum satis Emulsifiers and colours E 552 Calcium silicate E 553b Talc 50 mg/kg in the colour preparation Colours E 901 Beeswax, white and yellow quantum satis Colours E 1200 Polydextrose quantum satis All food additives E 1201 Polyvinylpyrrolidone quantum satis Sweeteners E 1202 Polyvinylpolypyrrolidone E 322 Lecithins quantum satis Glazing agents for fruit E 432 – E 436 Polysorbates E 470a Sodium, potassium and calcium salts of fatty acids E 471 Mono- and diglycerides of fatty acids E 491 – E 495 Sorbitan esters E 570 Fatty acids E 900 Dimethyl polysiloxane E 1521 Polyethylene glycol quantum satis Sweeteners E 425 Konjac quantum satis All food additives E 459 Beta-cyclodextrin 1 000  mg/kg in final food All food additives E 468 Crosslinked sodium carboxy methyl cellulose Cross-linked cellulose gum quantum satis Sweeteners E 469 Enzymatically hydrolysed carboxymethylcellulose Enzymatically hydrolysed cellulose gum quantum satis All food additives E 555 Potassium aluminium silicate 90 % relative to the pigment In E 171 titanium dioxide and E 172 iron oxides and hydroxides PART 2 Food additives other than carriers in food additives  ( *2 ) E number of the added food additive Name of the added food additive Maximum level Food additive preparations to which the food additive may be added Table 1   quantum satis All food additive preparations E 200 – E 203 Sorbic acid — sorbates (Table 2 of Part 6) 1 500  mg/kg singly or in combination in the preparation 15 mg/kg in the final product expressed as the free acid Colour preparations E 210 Benzoic acid E 211 Sodium benzoate E 212 Potassium benzoate E 220 – E 228 Sulphur dioxide — sulphites (Table 3 of Part 6) 100 mg/kg in the preparation and 2 mg/kg expressed as SO 2 in the final product as calculated Colour preparations (except E163 anthocyanins, E 150 b caustic sulphite caramel and E 150 d sulphite ammonia caramel)  ( *3 ) E 320 Butylated hydroxyanisole (BHA) 20 mg/kg singly or in combination (expressed on fat) in the preparation, 0,4 mg/kg in final product (singly or in combination) Emulsifiers containing fatty acids E 321 Butylated hydroxytoluene (BHT) E 338 Phosphoric acid 40 000  mg/kg singly or in combination in the preparation (expressed as P 2 O 5 ) Preparations of the colour E 163 anthocyanins E 339 Sodium phosphates E 340 Potassium phosphates E 343 Magnesium phosphates E 450 Diphosphates E 451 Triphosphates E 341 Calcium phosphates 40 000  mg/kg in the preparation (expressed as P 2 O 5 ) Colour and emulsifier preparations 10 000  mg/kg in the preparation (expressed as P 2 O 5 ) Polyol preparations 10 000  mg/kg in the preparation (expressed as P 2 O 5 ) E 412 guar gum preparations E 392 Extracts of rosemary 1 000  mg/kg in the preparation, 5 mg/kg in the final product expressed as the sum of carnosic acid and carnosol Colour preparations E 416 Karaya gum 50 000  mg/kg in the preparation, 1 mg/kg in final product Colour preparations E 432 – E 436 Polysorbates quantum satis Preparations of colours, fat soluble antioxidants and glazing agents for fruit E 473 Sucrose esters of fatty acids quantum satis Preparations of colours and fat soluble antioxidants E 475 Polyglycerol esters of fatty acids quantum satis Preparations of colours and fat soluble antioxidants E 476 Polyglycerol polyricinoleate 50 000  mg/kg in the preparation, 500 mg/kg in final food As emulsifier in preparations of colours used in:   Surimi and Japanese type Fish Products (Kamaboko) (E 120 cochineal, carminic acid, carmines)   Meat products, fish pastes and fruit preparations used in flavoured milk products and desserts (E163 anthocyanins, E100 curcumin and E120 cochineal, carminic acid, carmines) E 491 – E 495 Sorbitan esters (Table 5 of Part 6) quantum satis Preparations of colours, anti-foaming agents and glazing agents for fruit E 551 Silicon dioxide 50 000  mg/kg in the preparation Dry powdered colour preparations 10 000  mg/kg in the preparation E 508 potassium chloride and E 412 guar gum preparations E 551 Silicon dioxide 50 000  mg/kg in the preparation Dry powdered preparations of emulsifiers E 552 Calcium silicate E 551 Silicon dioxide 10 000  mg/kg in the preparation Dry powdered preparations of polyols E 552 Calcium silicate E 553a Magnesium silicate E 553b Talc E 900 Dimethyl polysiloxane 200 mg/kg in the preparation, 0,2 mg/l in final food Colour preparations of E 160 a carotenes, E 160 b annatto, bixin, norbixin, E 160 c Paprika extract, capsanthin, capsorubin, E 160 d lycopene and E 160 e beta-apo-8′-carotenal E 903 Carnauba wax 130 000  mg/kg in the preparation, 1 200  mg/kg in final product from all sources As stabiliser in preparations of sweeteners and/or acids intended to be used in chewing gum Note:     General rules for conditions of use of Food additives in Part 2 (1) Food Additives presented in Table 1 of Part 6 of this Annex, which are generally permitted for use in food under the general “ quantum satis ” principle included in Annex II Part C(1) Group I, have been included as food additives (other than for the purpose of carriers) in food additives under the general “ quantum satis ” principle, unless stated otherwise. (2) For phosphates and silicates maximum limits have been set only in the food additive preparation and not in the final food. (3) For all other food additives with a numerical ADI value maximum limits have been set for the food additive preparation and the final food. (4) No food additives are authorised for their function as colour, sweetener or flavour enhancer. PART 3 Food additives including carriers in food enzymes  ( *4 ) E number of the added food additive Name of the added food additive Maximum level in enzyme preparation Maximum level in final food except beverages Maximum level in beverages Can be used as a carrier? E 170 Calcium carbonate quantum satis quantum satis quantum satis Yes E 200 Sorbic acid 20 000  mg/kg (singly or in combination expressed as the free acid) 20  mg/kg 10  mg/l   E 202 Potassium sorbate E 210 Benzoic acid 5 000  mg/kg (singly or in combination expressed as the free acid) 12 000  mg/kg in rennet 1,7 mg/kg 5 mg/kg in cheese where rennet has been used 0,85 mg/l 2,5 mg/l in whey based beverages where rennet has been used   E 211 Sodium benzoate E 214 Ethyl-p-hydroxybenzoate 2 000  mg/kg (singly or in combination expressed as the free acid) 2  mg/kg 1  mg/l   E 215 Sodium ethyl p-hydroxybenzoate E 218 Methyl p-hydroxybenzoate E 219 Sodium methyl p-hydroxybenzoate E 220 Sulphur dioxide 2 000  mg/kg (singly or in combination expressed as SO 2 ) 5 000  mg/kg only in food enzymes for brewing 6 000  mg/kg only for barley beta-amylase 10 000  mg/kg only for papain in solid form 2  mg/kg 2  mg/l   E 221 Sodium sulphite E 222 Sodium hydrogen sulphite E 223 Sodium metabisulphite E 224 Potassium metabisulphite E 250 Sodium nitrite 500  mg/kg 0,01  mg/kg No use   E 260 Acetic acid quantum satis quantum satis quantum satis Yes E 261 Potassium acetate quantum satis quantum satis quantum satis   E 262 Sodium acetates quantum satis quantum satis quantum satis   E 263 Calcium acetate quantum satis quantum satis quantum satis   E 270 Lactic acid quantum satis quantum satis quantum satis Yes E 281 Sodium propionate quantum satis quantum satis 50  mg/l   E 290 Carbon dioxide quantum satis quantum satis quantum satis   E 296 Malic acid quantum satis quantum satis quantum satis Yes E 300 Ascorbic acid quantum satis quantum satis quantum satis Yes E 301 Sodium ascorbate quantum satis quantum satis quantum satis Yes E 302 Calcium ascorbate quantum satis quantum satis quantum satis Yes E 304 Fatty acid esters of ascorbic acid quantum satis quantum satis quantum satis   E 306 Tocopherol-rich extract quantum satis quantum satis quantum satis   E 307 Alpha-tocopherol quantum satis quantum satis quantum satis   E 308 Gamma-tocopherol quantum satis quantum satis quantum satis   E 309 Delta-tocopherol quantum satis quantum satis quantum satis   E 322 Lecithins quantum satis quantum satis quantum satis Yes E 325 Sodium lactate quantum satis quantum satis quantum satis   E 326 Potassium lactate quantum satis quantum satis quantum satis   E 327 Calcium lactate quantum satis quantum satis quantum satis Yes E 330 Citric acid quantum satis quantum satis quantum satis Yes E 331 Sodium citrates quantum satis quantum satis quantum satis Yes E 332 Potassium citrates quantum satis quantum satis quantum satis Yes E 333 Calcium citrates quantum satis quantum satis quantum satis   E 334 Tartaric acid (L(+)-) quantum satis quantum satis quantum satis   E 335 Sodium tartrates quantum satis quantum satis quantum satis Yes E 336 Potassium tartrates quantum satis quantum satis quantum satis Yes E 337 Sodium potassium tartrate quantum satis quantum satis quantum satis   E 350 Sodium malates quantum satis quantum satis quantum satis Yes E 338 Phosphoric acid 10 000  mg/kg (expressed as P 2 O 5 ) quantum satis quantum satis   E 339 Sodium phosphates 50 000  mg/kg (singly or in combination, expressed as P 2 O 5 ) quantum satis quantum satis Yes E 340 Potassium phosphates E 341 Calcium phosphates E 343 Magnesium phosphates E 351 Potassium malate quantum satis quantum satis quantum satis Yes E 352 Calcium malates quantum satis quantum satis quantum satis Yes E 354 Calcium tartrate quantum satis quantum satis quantum satis   E 380 Triammonium citrate quantum satis quantum satis quantum satis   E 400 Alginic acid quantum satis quantum satis quantum satis Yes E 401 Sodium alginate quantum satis quantum satis quantum satis Yes E 402 Potassium alginate quantum satis quantum satis quantum satis Yes E 403 Ammonium alginate quantum satis quantum satis quantum satis   E 404 Calcium alginate quantum satis quantum satis quantum satis Yes E 406 Agar quantum satis quantum satis quantum satis Yes E 407 Carrageenan quantum satis quantum satis quantum satis Yes E 407a Processed euchema seaweed quantum satis quantum satis quantum satis   E 410 Locust bean gum quantum satis quantum satis quantum satis Yes E 412 Guar gum quantum satis quantum satis quantum satis Yes E 413 Tragacanth quantum satis quantum satis quantum satis Yes E 414 Acacia gum (gum arabic) quantum satis quantum satis quantum satis Yes E 415 Xanthan gum quantum satis quantum satis quantum satis Yes E 417 Tara gum quantum satis quantum satis quantum satis Yes E 418 Gellan gum quantum satis quantum satis quantum satis Yes E 420 Sorbitol quantum satis quantum satis quantum satis Yes E 421 Mannitol quantum satis quantum satis quantum satis Yes E 422 Glycerol quantum satis quantum satis quantum satis Yes E 440 Pectins quantum satis quantum satis quantum satis Yes E 450 Diphosphates 50 000  mg/kg (singly or in combination expressed as P 2 O 5 ) quantum satis quantum satis   E 451 Triphosphates E 452 Polyphosphates E 460 Cellulose quantum satis quantum satis quantum satis Yes E 461 Methyl cellulose quantum satis quantum satis quantum satis Yes E 462 Ethyl cellulose quantum satis quantum satis quantum satis   E 463 Hydroxypropyl cellulose quantum satis quantum satis quantum satis Yes E 464 Hydroxypropyl methyl cellulose quantum satis quantum satis quantum satis Yes E 465 Ethyl methyl cellulose quantum satis quantum satis quantum satis   E 466 Carboxy methyl cellulose Sodium carboxy methyl cellulose Cellulose gum quantum satis quantum satis quantum satis Yes E 469 Enzymatically hydrolysed carboxy methyl cellulose quantum satis quantum satis quantum satis   E 470a Sodium, potassium and calcium salts of fatty acids quantum satis quantum satis quantum satis   E 470b Magnesium salts of fatty acids quantum satis quantum satis quantum satis   E 471 Mono- and diglycerides of fatty acids quantum satis quantum satis quantum satis Yes E 472a Acetic acid esters of mono- and diglycerides of fatty acids quantum satis quantum satis quantum satis Yes E 472b Lactic acid esters of mono- and diglycerides of fatty acids quantum satis quantum satis quantum satis Yes E 472c Citric acid esters of mono- and diglycerides of fatty acids quantum satis quantum satis quantum satis Yes E 472d Tartaric acid esters of mono- and diglycerides of fatty acids quantum satis quantum satis quantum satis Yes E 472e Mono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids quantum satis quantum satis quantum satis Yes E 472f Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids quantum satis quantum satis quantum satis Yes E 473 Sucrose esters of fatty acids 50 000  mg/kg 50  mg/kg 25  mg/L Yes, only as a carrier E 500 Sodium carbonates quantum satis quantum satis quantum satis Yes E 501 Potassium carbonates quantum satis quantum satis quantum satis Yes, E 501 (i) potassium carbonate only E 503 Ammonium carbonates quantum satis quantum satis quantum satis Yes E 504 Magnesium carbonates quantum satis quantum satis quantum satis Yes E 507 Hydrochloric acid quantum satis quantum satis quantum satis Yes E 508 Potassium chloride quantum satis quantum satis quantum satis Yes E 509 Calcium chloride quantum satis quantum satis quantum satis Yes E 511 Magnesium chloride quantum satis quantum satis quantum satis Yes E 513 Sulphuric acid quantum satis quantum satis quantum satis Yes E 514 Sodium sulphates quantum satis quantum satis quantum satis Yes, E 514 (i) sodium sulphate only E 515 Potassium sulphates quantum satis quantum satis quantum satis Yes E 516 Calcium sulphate quantum satis quantum satis quantum satis Yes E 517 Ammonium sulphate 100 000  mg/kg 100  mg/kg 50  mg/l Yes E 524 Sodium hydroxide quantum satis quantum satis quantum satis   E 525 Potassium hydroxide quantum satis quantum satis quantum satis Yes E 526 Calcium hydroxide quantum satis quantum satis quantum satis Yes E 527 Ammonium hydroxide quantum satis quantum satis quantum satis Yes E 528 Magnesium hydroxide quantum satis quantum satis quantum satis Yes E 529 Calcium oxide quantum satis quantum satis quantum satis Yes E 530 Magnesium oxide quantum satis quantum satis quantum satis   E 551 Silicon dioxide 50 000  mg/kg in the dry powdered preparation quantum satis quantum satis Yes E 570 Fatty acids quantum satis quantum satis quantum satis   E 574 Gluconic acid quantum satis quantum satis quantum satis Yes E 575 Glucono-delta-lactone quantum satis quantum satis quantum satis Yes E 576 Sodium gluconate quantum satis quantum satis quantum satis   E 577 Potassium gluconate quantum satis quantum satis quantum satis   E 578 Calcium gluconate quantum satis quantum satis quantum satis Yes E 640 Glycine and its sodium salt quantum satis quantum satis quantum satis   E 920 L-cysteine 10 000  mg/kg 10  mg/kg 5  mg/l   E 938 Argon quantum satis quantum satis quantum satis   E 939 Helium quantum satis quantum satis quantum satis   E 941 Nitrogen quantum satis quantum satis quantum satis   E 942 Nitrous oxide quantum satis quantum satis quantum satis   E 948 Oxygen quantum satis quantum satis quantum satis   E 949 Hydrogen quantum satis quantum satis quantum satis   E 965 Maltitol quantum satis quantum satis quantum satis Yes E 966 Lactitol quantum satis quantum satis quantum satis Yes (only as a carrier) E 967 Xylitol quantum satis quantum satis quantum satis Yes (only as a carrier) E 1200 Polydextrose quantum satis quantum satis quantum satis Yes E 1404 Oxidised starch quantum satis quantum satis quantum satis Yes E 1410 Monostarch phosphate quantum satis quantum satis quantum satis Yes E 1412 Distarch phosphate quantum satis quantum satis quantum satis Yes E 1413 Phosphated distarch phosphate quantum satis quantum satis quantum satis Yes E 1414 Acetylated distarch phosphate quantum satis quantum satis quantum satis Yes E 1420 Acetylated starch quantum satis quantum satis quantum satis Yes E 1422 Acetylated distarch adipate quantum satis quantum satis quantum satis Yes E 1440 Hydroxy propyl starch quantum satis quantum satis quantum satis Yes E 1442 Hydroxy propyl distarch phosphate quantum satis quantum satis quantum satis Yes E 1450 Starch sodium octenyl succinate quantum satis quantum satis quantum satis Yes E 1451 Acetylated oxidised starch quantum satis quantum satis quantum satis Yes E 1520 Propane-1, 2-diol (propylene glycol) 500  g/kg (see footnote)  ( *5 ) (see footnote)  ( *5 ) Yes, only as a carrier Note:     General rules for conditions of use of Food additives in Part 3 (1) Food Additives presented in Table 1 of Part 6 of this Annex, which are generally permitted for use in food under the general “ quantum satis ” principle, included in Annex II Part C(1) Group I, have been included as food additives in food enzymes under the general “ quantum satis ” principle, unless stated otherwise. (2) For phosphates and silicates, when used as additives, maximum limits have been set only in the food enzyme preparation and not in the final food. (3) For all other food additives with a numerical ADI value maximum limits have been set for the food enzyme preparation and the final food. (4) No food additives are authorised for their function as colour, sweetener or flavour enhancer. PART 4 Food additives including carriers in food flavourings E number of the additive Name of the additive Flavouring categories to which the additive may be added Maximum level Table 1   All flavourings quantum satis E 420 E 421 E 953 E 965 E 966 E 967 E 968 Sorbitol Mannitol Isomalt Maltitol Lactitol Xylitol Erythritol All flavourings quantum satis for purposes other than sweetening, not as flavour enhancers E 200 – E 203 E 210 E 211 E 212 E 213 Sorbic acid and sorbates (Table 2 of Part 6), Benzoic acid, Sodium benzoate, Potassium benzoate Calcium benzoate All flavourings 1 500  mg/kg (singly or in combination expressed as the free acid) in flavourings E 310 E311 E 312 E 319 E 320 Propyl gallate Octyl gallate Dodecyl gallate Tertiary-butyl hydroquinone (TBHQ) Butylated hydroxyanisole (BHA) Essential oils 1 000  mg/kg (gallates, TBHQ and BHA, individually or in combination) in the essential oils Flavourings other than essential oils 100 mg/kg  ( *6 ) (gallates, individually or in combination) 200 mg/kg  ( *6 ) (TBHQ and BHA, individually or in combination) in flavourings E 338 – E 452 Phosphoric acid — phosphates — di-, tri- and polyphosphates (Table 6 of Part 6) All flavourings 40 000  mg/kg (singly or in combination expressed as P 2 O 5 ) in flavourings E 392 Extracts of rosemary All flavourings 1 000  mg/kg (expressed as the sum of carnosol and carnosic acid) in flavourings E 416 Karaya gum All flavourings 50 000  mg/kg in flavourings E 425 Konjac All flavourings quantum satis E 432 – E 436 Polysorbates (Table 4 of Part 6) All flavourings, except liquid smoke flavourings and flavourings based on spice oleoresins  ( *7 ) 10 000  mg/kg in flavourings Foodstuffs containing liquid smoke flavourings and flavourings based on spice oleoresins 1 000  mg/kg in final food E 459 Beta-cyclodextrin Encapsulated flavourings in: — flavoured teas and flavoured powdered instant drinks 500 mg/l in final food — flavoured snacks 1 000  mg/kg in foodstuffs as consumed or as reconstituted according to the instructions of the manufacturer E 551 Silicon dioxide All flavourings 50 000  mg/kg in flavourings E 900 Dimethyl polysiloxane All flavourings 10 mg/kg in flavourings E 901 Beeswax Flavourings in non-alcoholic flavoured drinks 200 mg/l in flavoured drinks E 1505 Triethyl citrate All flavourings 3 000  mg/kg from all sources in foodstuffs as consumed or as reconstituted according to the instructions of the manufacturer; individually or in combination. In the case of beverages, with the exception of cream liqueurs, the maximum level of E 1520 shall be 1 000  mg/l from all sources E 1517 Glyceryl diacetate (diacetin) E 1518 Glyceryl triacetate (triacetin) E 1520 Propane-1, 2-diol (propylene glycol) E 1519 Benzyl alcohol Flavourings for: — liqueurs, aromatised wines, aromatised wine-based drinks and aromatised wine-products cocktails 100 mg/l in final food — confectionery including chocolate and fine bakery wares 250 mg/kg from all sources in foodstuffs as consumed or as reconstituted according to instruction of the manufacturer PART 5 Food additives in nutrients Section A — Food additives in nutrients except nutrients intended to be used in foodstuffs for infants and young children listed in point 13.1 of Part E of Annex II: E number of the food additive Name of the food additive Maximum level Nutrient to which the food additive may be added Can be used as a carrier? E 170 Calcium carbonate quantum satis All nutrients Yes E 260 Acetic acid quantum satis All nutrients   E 261 Potassium acetate quantum satis All nutrients   E 262 Sodium acetates quantum satis All nutrients   E 263 Calcium acetate quantum satis All nutrients   E 270 Lactic acid quantum satis All nutrients   E 290 Carbon dioxide quantum satis All nutrients   E 296 Malic acid quantum satis All nutrients   E 300 Ascorbic acid quantum satis All nutrients   E 301 Sodium ascorbate quantum satis All nutrients   E 302 Calcium ascorbate quantum satis All nutrients   E 304 Fatty acid esters of ascorbic acid quantum satis All nutrients   E 306 Tocopherol-rich extract quantum satis All nutrients   E 307 Alpha-tocopherol quantum satis All nutrients   E 308 Gamma-tocopherol quantum satis All nutrients   E 309 Delta-tocopherol quantum satis All nutrients   E 322 Lecithins quantum satis All nutrients Yes E 325 Sodium lactate quantum satis All nutrients   E 326 Potassium lactate quantum satis All nutrients   E 327 Calcium lactate quantum satis All nutrients   E 330 Citric acid quantum satis All nutrients   E 331 Sodium citrates quantum satis All nutrients   E 332 Potassium citrates quantum satis All nutrients   E 333 Calcium citrates quantum satis All nutrients   E 334 Tartaric acid (L(+)-) quantum satis All nutrients   E 335 Sodium tartrates quantum satis All nutrients   E 336 Potassium tartrates quantum satis All nutrients   E 337 Sodium potassium tartrate quantum satis All nutrients   E 338 – E 452 Phosphoric acid — phosphates — di-, tri- and polyphosphates (Table 6 of Part 6) 40 000  mg/kg expressed as P 2 O 5 in the nutrient preparation All nutrients   E 350 Sodium malates quantum satis All nutrients   E 351 Potassium malate quantum satis All nutrients   E 352 Calcium malates quantum satis All nutrients   E 354 Calcium tartrate quantum satis All nutrients   E 380 Triammonium citrate quantum satis All nutrients   E 392 Extracts of rosemary 1 000  mg/kg in the preparation of beta-carotene and lycopene, 5 mg/kg in final product expressed as the sum of carnosic acid and carnosol In beta-carotene and lycopene preapartions   E 400 – E 404 Alginic acid — alginates (Table 7 of Part 6) quantum satis All nutrients Yes E 406 Agar quantum satis All nutrients Yes E 407 Carrageenan quantum satis All nutrients Yes E 407a Processed euchema seaweed quantum satis All nutrients Yes E 410 Locust bean gum quantum satis All nutrients Yes E 412 Guar gum quantum satis All nutrients Yes E 413 Tragacanth quantum satis All nutrients Yes E 414 Acacia gum (gum arabic) quantum satis All nutrients Yes E 415 Xanthan gum quantum satis All nutrients Yes E 417 Tara gum quantum satis All nutrients Yes E 418 Gellan gum quantum satis All nutrients Yes E 420 Sorbitol quantum satis All nutrients Yes, only as a carrier E 421 Mannitol quantum satis All nutrients Yes, only as a carrier E 422 Glycerol quantum satis All nutrients Yes E 432 – E 436 Polysorbates (Table 4 of Part 6) quantum satis only in beta carotene, lutein, lycopene and vitamin E preparations. In vitamin A and D preparations maximum level in final food 2 mg/kg In beta carotene, lutein, lycopene and vitamins A, D and E preparations Yes E 440 Pectins quantum satis All nutrients Yes E 459 Beta-cyclodextrin 100 000  mg/kg in the preparation and 1 000  mg/kg in final food All nutrients Yes E 460 Cellulose quantum satis All nutrients Yes E 461 Methyl cellulose quantum satis All nutrients Yes E 462 Ethyl cellulose quantum satis All nutrients Yes E 463 Hydroxypropyl cellulose quantum satis All nutrients Yes E 464 Hydroxypropyl methyl cellulose quantum satis All nutrients Yes E 465 Ethyl methyl cellulose quantum satis All nutrients Yes E 466 Carboxy methyl cellulose Sodium carboxy methyl cellulose Cellulose gum quantum satis All nutrients Yes E 469 Enzymatically hydrolysed carboxy methyl cellulose quantum satis All nutrients Yes E 470a Sodium, potassium and calcium salts of fatty acids quantum satis All nutrients Yes E 470b Magnesium salts of fatty acids quantum satis All nutrients Yes E 471 Mono- and diglycerides of fatty acids quantum satis All nutrients Yes E 472a Acetic acid esters of mono- and diglycerides of fatty acids quantum satis All nutrients Yes E 472b Lactic acid esters of mono- and diglycerides of fatty acids quantum satis All nutrients Yes E 472c Citric acid esters of mono- and diglycerides of fatty acids quantum satis All nutrients Yes E 472d Tartaric acid esters of mono- and diglycerides of fatty acids quantum satis All nutrients Yes E 472e Mono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids quantum satis All nutrients Yes E 472f Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids quantum satis All nutrients Yes E 473 Sucrose esters of fatty acids quantum satis In beta carotene, lutein, lycopene and vitamin E preparations Yes 2 mg/kg in final food In vitamin A and D preparations E 475 Polyglycerol esters of fatty acids quantum satis In beta carotene, lutein, lycopene and vitamin E preparations Yes 2 mg/kg in final food In vitamin A and D preparations E 491 – E 495 Sorbitan esters (Table 5 of Part 6) quantum satis In beta carotene, lutein, lycopene and vitamin E preparations Yes 2 mg/kg in final food In vitamin A and D preparations E 500 Sodium carbonates quantum satis All nutrients Yes E 501 Potassium carbonates quantum satis All nutrients Yes E 503 Ammonium carbonates quantum satis All nutrients Yes E 504 Magnesium carbonates quantum satis All nutrients Yes E 507 Hydrochloric acid quantum satis All nutrients Yes E 508 Potassium chloride quantum satis All nutrients   E 509 Calcium chloride quantum satis All nutrients   E 511 Magnesium chloride quantum satis All nutrients   E 513 Sulphuric acid quantum satis All nutrients   E 514 Sodium sulphates quantum satis All nutrients   E 515 Potassium sulphates quantum satis All nutrients   E 516 Calcium sulphate quantum satis All nutrients   E 524 Sodium hydroxide quantum satis All nutrients   E 525 Potassium hydroxide quantum satis All nutrients   E 526 Calcium hydroxide quantum satis All nutrients   E 527 Ammonium hydroxide quantum satis All nutrients   E 528 Magnesium hydroxide quantum satis All nutrients   E 529 Calcium oxide quantum satis All nutrients Yes E 530 Magnesium oxide quantum satis All nutrients Yes E 551, E 552 Silicon dioxide Calcium silicate 50 000  mg/kg in the dry powdered preparation (singly or in combination) In dry powdered preparations of all nutrients   10 000  mg/kg in the preparation (E 551 only) In potassium chloride preparations used in salt substitutes E 554 Sodium aluminium silicate 15 000  mg/kg in the preparation In fat soluble vitamin preparations   E 570 Fatty acids quantum satis All nutrients except nutrients containing unsaturated fatty acids   E 574 Gluconic acid quantum satis All nutrients   E 575 Glucono-delta-lactone quantum satis All nutrients   E 576 Sodium gluconate quantum satis All nutrients   E 577 Potassium gluconate quantum satis All nutrients   E 578 Calcium gluconate quantum satis All nutrients   E 640 Glycine and its sodium salt quantum satis All nutrients   E 900 Dimethyl polysiloxane 200 mg/kg in the preparation, 0,2 mg/l in final food In preparations of beta-carotene and lycopene   E 901 Beeswax, white and yellow quantum satis All nutrients Yes, only as a carrier E 938 Argon quantum satis All nutrients   E 939 Helium quantum satis All nutrients   E 941 Nitrogen quantum satis All nutrients   E 942 Nitrous oxide quantum satis All nutrients   E 948 Oxygen quantum satis All nutrients   E 949 Hydrogen quantum satis All nutrients   E 953 Isomalt quantum satis All nutrients Yes, only as a carrier E 965 Maltitol quantum satis All nutrients Yes, only as a carrier E 966 Lactitol quantum satis All nutrients Yes, only as a carrier E 967 Xylitol quantum satis All nutrients Yes, only as a carrier E 968 Erythritol quantum satis All nutrients Yes, only as a carrier E 1103 Invertase quantum satis All nutrients   E 1200 Polydextrose quantum satis All nutrients Yes E 1404 Oxidised starch quantum satis All nutrients Yes E 1410 Monostarch phosphate quantum satis All nutrients Yes E 1412 Distarch phosphate quantum satis All nutrients Yes E 1413 Phosphated distarch phosphate quantum satis All nutrients Yes E 1414 Acetylated distarch phosphate quantum satis All nutrients Yes E 1420 Acetylated starch quantum satis All nutrients Yes E 1422 Acetylated distarch adipate quantum satis All nutrients Yes E 1440 Hydroxy propyl starch quantum satis All nutrients Yes E 1442 Hydroxy propyl distarch phosphate quantum satis All nutrients Yes E 1450 Starch sodium octenyl succinate quantum satis All nutrients Yes E 1451 Acetylated oxidised starch quantum satis All nutrients Yes E 1452 Starch Aluminium Octenyl Succinate 35 000  mg/kg in final food In food supplements as defined in Directive 2002/46/EC due to its use in vitamin preparations for encapsulation purposes only Yes E 1518 Glyceryl triacetate (triacetin)  ( *8 ) All nutrients Yes, only as a carrier E 1520  ( *8 ) Propane-1, 2-diol (propylene glycol) 1 000  mg/kg in final food (as carry-over) All nutrients Yes, only as a carrier Section B — Food additives added in nutrients intended to be used in foodstuffs for infants and young children listed in Point 13.1 of Part E of Annex II: E number of the food additive Name of the food additive Maximum level Nutrient to which the food additive may be added Food category E 301 Sodium ascorbate Total carry-over 75 mg/l Coatings of nutrient preparations containing polyunsaturated fatty acids Foods for infants and young children E 304 (i) Ascorbyl palmitate For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded All nutrients Foods for infants and young children E 306 E 307 E 308 E 309 Tocopherol-rich extract Alpha-tocopherol Gamma-tocopherol Delta-tocopherol For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded All nutrients Foods for infants and young children E 322 Lecithins For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded All nutrients Foods for infants and young children E 330 Citric acid quantum satis All nutrients Foods for infants and young children E 331 Sodium citrates For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded and the conditions of use specified therein are respected All nutrients Foods for infants and young children E 332 Potassium citrates For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded and the conditions of use specified therein are respected All nutrients Foods for infants and young children E 333 Calcium citrates Total carry-over 0,1 mg/kg expressed as calcium and within the limit of calcium level and calcium/phosphorus ratio as set for the food category All nutrients Foods for infants and young children E 341 (iii) Tricalcium phosphate Maximum level of 1 000  mg/kg expressed as P 2 O 5 from all uses in final food mentioned in point 13.1.3 of Part E of Annex II should be respected (only for E 341 (iii) with a provision on a maximum level of aluminium) All nutrients Processed cereal based foods and baby foods for infants and young children as defined by Directive 2006/125/EC E 401 Sodium alginate For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded All nutrients Processed cereal based foods and baby foods for infants and young children as defined by Directive 2006/125/EC E 402 Potassium alginate For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded All nutrients Processed cereal based foods and baby foods for infants and young children as defined by Directive 2006/125/EC E 404 Calcium alginate For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded All nutrients Processed cereal based foods and baby foods for infants and young children as defined by Directive 2006/125/EC E 414 Gum arabic (acacia gum) 150 000  mg/kg in the nutrient preparation and 10 mg/kg carry-over in final product All nutrients Foods for infants and young children E 415 Xanthan gum For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded All nutrients Processed cereal based foods and baby foods for infants and young children as defined by Directive 2006/125/EC E 421 Mannitol 1 000 times more than vitamin B12, 3 mg/kg total carry-over As carrier for vitamin B12 Foods for infants and young children E 440 Pectins For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded All nutrients Follow-on formulae and processed cereal based foods and baby foods for infants and young children as defined by Directive 2006/125/EC E 466 Carboxy methyl cellulose, Sodium carboxy methyl cellulose, Cellulose gum For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded All nutrients Dietary foods for infants and young children for special medical purposes as defined in Directive 1999/21/EC E 471 Mono- and diglycerides of fatty acids For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded and the conditions of use specified therein are respected All nutrients Foods for infants and young children E 472c Citric acid esters of mono- and diglycerides of fatty acids For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded All nutrients Infant formulae and follow-on formulae for infants and young children in good health E 551 Silicon dioxide 10 000  mg/kg in nutrient preparations Dry powdered nutrient preparations Foods for infants and young children E 1420 Acetylated starch For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded All nutrients Processed cereal based foods and baby foods for infants and young children as defined by Directive 2006/125/EC E 1450 Starch sodium octenyl succinate Carry-over 100 mg/kg Vitamin preparations Foods for infants and young children Carry-over 1 000  mg/kg Polyunsaturated fatty acid preparations E 1451 Acetylated oxidised starch For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded All nutrients Processed cereal based foods and baby foods for infants and young children as defined by Directive 2006/125/EC Note:     General rules for conditions of use of Food additives in Part 5 (1) Food Additives presented in Table 1 of Part 6 of this Annex, which are generally permitted for use in food under the general “ quantum satis ” principle, included in Annex II Part C(1) Group I, have been included as food additives in nutrients under the general “ quantum satis ” principle, unless stated otherwise. (2) For phosphates and silicates, when used as additives, maximum limits have been set only in the nutrient preparation and not in the final food. (3) For all other food additives with a numerical ADI value maximum limits have been set for the nutrient preparation and the final food. (4) No food additives are authorised for their function as colour, sweetener or flavour enhancer. PART 6 Definitions of groups of food additives for the purposes of Parts 1 to 5 Table 1 E number Name E 170 Calcium carbonate E 260 Acetic acid E 261 Potassium acetate E 262 Sodium acetates E 263 Calcium acetate E 270 Lactic acid E 290 Carbon dioxide E 296 Malic acid E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate 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 E 322 Lecithins 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 (L(+)-) E 335 Sodium tartrates E 336 Potassium tartrates E 337 Sodium potassium tartrate E 350 Sodium malates E 351 Potassium malate E 352 Calcium malates 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 euchema 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 E 460 Cellulose E 461 Methyl cellulose E 462 Ethyl 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 hydrolysed 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 E 501 Potassium carbonates E 503 Ammonium carbonates E 504 Magnesium carbonates E 507 Hydrochloric acid E 508 Potassium chloride E 509 Calcium chloride E 511 Magnesium chloride E 513 Sulphuric acid E 514 Sodium sulphates E 515 Potassium sulphates 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 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 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 Hydroxy propyl starch E 1442 Hydroxy propyl distarch phosphate E 1450 Starch sodium octenyl succinate E 1451 Acetylated oxidised starch Table 2 Sorbic acid — sorbates E-number Name E 200 Sorbic acid E 202 Potassium sorbate E 203 Calcium sorbate Table 3 Sulphur dioxide — sulphites E-number 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 Table 4 Polysorbates E-number Name 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) E 436 Polyoxyethylene sorbitan tristearate (polysorbate 65) Table 5 Sorbitan esters E-number Name E 491 Sorbitan monostearate E 492 Sorbitan tristearate E 493 Sorbitan monolaurate E 494 Sorbitan monooleate E 495 Sorbitan monopalmitate Table 6 Phosphoric acid — phosphates — di-, tri- and polyphosphates E-number Name E 338 Phosphoric acid E 339 Sodium phosphates E 340 Potassium phosphates E 341 Calcium phosphates E 343 Magnesium phosphates E 450 Diphosphates E 451 Triphosphates E 452 Polyphosphates Table 7 Alginic acid — alginates E-number Name E 400 Alginic acid E 401 Sodium alginate E 402 Potassium alginate E 403 Ammonium alginate’ ( *1 )   Maximum level from all sources in foodstuffs 3 000 mg/kg (individually or in combination with E 1505, E 1517 and E 1518). In the case of beverages, with the exception of cream liqueurs, the maximum level of E 1520 shall be 1 000 mg/l from all sources. ( *2 )   Except enzymes authorised as food additives. ( *3 )   E 163 anthocyanins may contain up to 100 000 mg/kg sulphites. E 150 b caustic sulphite caramel and E 150 d sulphite ammonia caramel may contain 2 000 mg/kg according to the purity criteria (Directive 2008/128/EC). ( *4 )   Including enzymes authorised as food additives. ( *5 )   Maximum level from all sources in foodstuffs 3 000 mg/kg (individually or in combination with E 1505, E 1517 and E 1518). In the case of beverages, with the exception of cream liqueurs, the maximum level of E 1520 shall be 1 000 mg/l from all sources. ( *6 )   Proportionality rule: when combinations of gallates, TBHQ, and BHA are used, the individual levels must be reduced proportionally. ( *7 )   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. ( *8 )   Maximum level for E 1518 and E 1520 from all sources in foodstuffs 3 000 mg/kg (individually or in combination with E 1505 and E 1517). In the case of beverages, with the exception of cream liqueurs, the maximum level of E 1520 shall be 1 000 mg/l from all sources.