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 l... (European Union)

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 additive

Published: 2011-11-11

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12.11.2011

Official Journal of the European Union

L 295/178

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 (1), 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 (2) 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 (3) 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 (4) 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 (5), Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (6), 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 (7), 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 (8).

(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 (9) 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 (10) 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 (11), 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs (12) and 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (13).

(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:

Article 1

Amendment to Regulation (EC) No 1333/2008

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

Article 2

Transitional measures

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.

Article 3

Entry into force

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

(1) OJ L 354, 31.12.2008, p. 16.

(2) OJ L 61, 18.3.1995, p. 1.

(3) OJ L 354, 31.12.2008, p. 7.

(4) OJ L 404, 30.12.2006, p. 26.

(5) OJ L 183, 12.7.2002, p. 51.

(6) OJ L 124, 20.5.2009, p. 21.

(7) OJ L 269, 14.10.2009, p. 9.

(8) Opinion of the Scientific Committee on Food on Additives in nutrient preparations for use in infant formulae, follow-on formulae and weaning food, Reports of SCF (40th series, 1998).

(9) Report from the Commission on Dietary Food Additive Intake in the European Union COM(2001) 542 final.

(10) OJ L 80, 26.3.2010, p. 19.

(11) OJ L 6, 10.1.2009, p. 20.

(12) OJ L 158, 18.6.2008, p. 17.

(13) OJ L 253, 20.9.2008, p. 1.

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.

“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	quantum satis	Emulsifiers and colours
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	quantum satis	Sweeteners
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 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) (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 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 (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		20 mg/kg	10 mg/l
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		1,7 mg/kg 5 mg/kg in cheese where rennet has been used
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) (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 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 (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 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
E 473	Sucrose esters of fatty acids	2 mg/kg in final food	In vitamin A and D preparations	Yes
E 475	Polyglycerol esters of fatty acids	quantum satis	In beta carotene, lutein, lycopene and vitamin E preparations	Yes
E 475	Polyglycerol esters of fatty acids	2 mg/kg in final food	In vitamin A and D preparations	Yes
E 491 – E 495	Sorbitan esters (Table 5 of Part 6)	quantum satis	In beta carotene, lutein, lycopene and vitamin E preparations	Yes
E 491 – E 495	Sorbitan esters (Table 5 of Part 6)	2 mg/kg in final food	In vitamin A and D preparations	Yes
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
E 551, E 552	Silicon dioxide Calcium silicate	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 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
E 1450	Starch sodium octenyl succinate	Carry-over 1 000 mg/kg	Polyunsaturated fatty acid preparations	Foods for infants and young children
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.