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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives , and in particular Articles 10 and 30(2), (3) and (5) thereof,
Whereas:
(1)
Annex III to Regulation (EC) No 1333/2008 provides for the establishment of Union lists of approved food additives and their conditions of use in food additives (Parts 1 and 2), in food enzymes (Part 3), in food flavourings (Part 4) and in nutrients or categories thereof (Part 5), to which the food additives may be added according to Article 4(4) of that Regulation. The aim of the use of those food additives is to have a technological function in food additives or enzymes or flavourings or nutrients.
(2)
Food additives included in Annex III to Regulation (EC) No 1333/2008 may be assigned one of the functional classes laid down in Annex I on the basis of the principal technological function of the food additive. However, according to Article 9 of that Regulation, allocating a food additive to a functional class should not preclude it from being used for several functions.
(3)
Food additives authorised having a function as carriers for use in food additives in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners and their conditions of use should be included in Part 1 of Annex III to Regulation (EC) No 1333/2008 as their compliance with general conditions for inclusion and use of food additives in Union lists and particularly with Article 6(1)(a) of that Regulation has been reviewed.
(4)
Food additives listed as permitted carriers and carrier solvents in Directive 95/2/EC and having a function as a food additive other than carrier, should be included in Part 2 of Annex III to Regulation (EC) No 1333/2008 with the same conditions of use. Other food additives having a function other than carriers should also be included in this list.
(5)
Food additives and carriers authorised for use in food enzymes as referred to in Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on enzymes and their conditions of use should be included in Part 3 of Annex III to Regulation (EC) No 1333/2008.
(6)
Food additives authorised for use in food flavourings in Directive 95/2/EC and their conditions of use should be included in Part 4 of Annex III to Regulation (EC) No 1333/2008, as their compliance with Article 6 of that Regulation has been reviewed.
(7)
Food additives and carriers authorised for use in nutrients defined by Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods as well as by Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements , Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses , and Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses , and their conditions of use should be included in Part 5 Section A of Annex III to Regulation (EC) No 1333/2008. Other food additives having a function other than carriers should also be included in that list, because of a technological need, which was not foreseen at the time of the adoption of Regulation (EC) No 1333/2008.
(8)
Food additives listed as food additives permitted in foods for infants and young children by Directive 95/2/EC and having a function as a food additive in nutrients should be included with the same conditions of use in the list set out in Part 5 Section B of Annex III to Regulation (EC) No 1333/2008. That list should be completed by taking into account the opinion of Scientific Committee on Food on additives in nutrient preparations for use in infant formulae, follow-on formulae and weaning food of 13 June 1997 .
(9)
For the reasons of transparency and consistency specific rules for conditions of use of food additives in food additive/enzyme/nutrient preparation should be laid down.
(10)
Substances like sulphites, benzoates, polysorbates, sorbitan esters and sucrose esters should be listed in Annex III to Regulation (EC) No 1333/2008; those substances are subject to tier 3 screening according to Commission Report of 2001 on Dietary Food Additive Intake in the European Union and are raising concerns with respect to the ADI value. The conditions of use of those substances may be revised as a follow-up of the expected opinion of the European Food Safety Authority in the framework of the re-evaluation programme as established by Commission Regulation (EU) No 257/2010 setting up a programme for the re-evaluation of approved additives, which includes among others an intake assessment.
(11)
The specifications of food additives listed in Annex III to Regulation (EC) No 1333/2008 relating to origin, purity criteria and any other necessary information are set out in Commission Directives 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs , 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs and 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners .
(12)
Due to the fact that some of preparations have been used since decades, a transitional period of 24 months following the entry into force of this Regulation should be provided to enable the food business operators to adapt to the requirements laid down in Parts 2, 3 and 5 Section A of Annex III to Regulation (EC) No 1333/2008 as amended by this Regulation. A transitional period of 18 months following the entry into force of this Regulation should be provided to enable the food business operators to adapt to the requirements laid down in Parts 1 and 4 of the Annex III as amended by this Regulation.
(13)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
HAS ADOPTED THIS REGULATION:

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.
This Regulation shall be binding in its entirety and directly applicable in the Member States.
Done at Brussels, 11 November 2011.
For the Commission
The President
José Manuel Barroso
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
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.
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) | 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 | Triethyl citrate
E 1518 | 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
Except enzymes authorised as food additives.
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).
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 SO2 in the final product as calculated | Colour preparations (except E163 anthocyanins, E 150 b caustic sulphite caramel and E 150 d sulphite ammonia caramel)
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 P2O5) | 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 P2O5) | Colour and emulsifier preparations
10 000 mg/kg in the preparation (expressed as P2O5) | Polyol preparations
10 000 mg/kg in the preparation (expressed as P2O5) | 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
Including enzymes authorised as food additives.
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.
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 SO2) 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 P2O5) | quantum satis | quantum satis |
E 339 | Sodium phosphates | 50 000 mg/kg (singly or in combination, expressed as P2O5) | 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 P2O5) | 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) | (see footnote) | 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
Proportionality rule: when combinations of gallates, TBHQ, and BHA are used, the individual levels must be reduced proportionally.
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.
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 (gallates, individually or in combination) 200 mg/kg (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 P2O5) 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 | 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:
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.
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 P2O5 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) | | All nutrients | Yes, only as a carrier
E 1520 | 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 P2O5 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
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