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Document 32011R1130

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

OJ L 295, 12.11.2011, p. 178–204 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
Special edition in Croatian: Chapter 15 Volume 020 P. 132 - 158

In force

ELI: http://data.europa.eu/eli/reg/2011/1130/oj

12.11.2011   

EN

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.

2.

“preparation” for the purposes of this Annex means a formulation consisting of one or more food additives, food enzymes and/or nutrients in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardisation, dilution or dissolution.

PART 1

Carriers in food additives

E number of the carrier

Name of the carrier

Maximum level

Food additives to which the carrier may be added

E 1520

Propane-1, 2-diol (propylene glycol)

1 000 mg/kg in final food (as carry-over) (1)

Colours, emulsifiers and antioxidants

E 422

Glycerol

quantum satis

All food additives

E 420

Sorbitol

E 421

Mannitol

E 953

Isomalt

E 965

Maltitol

E 966

Lactitol

E 967

Xylitol

E 968

Erythritol

E 400 – E 404

Alginic acid – alginates (Table 7 of Part 6)

E 405

Propane-1, 2-diol alginate

E 406

Agar

E 407

Carrageenan

E 410

Locust bean gum

E 412

Guar gum

E 413

Tragacanth

E 414

Gum arabic (acacia gum)

E 415

Xanthan gum

E 440

Pectins

E 432 – E 436

Polysorbates (Table 4 of Part 6)

quantum satis

Antifoaming agents

E 442

Ammoniumphosphatides

quantum satis

Antioxidants

E 460

Cellulose

quantum satis

All food additives

E 461

Methyl cellulose

E 462

Ethyl cellulose

E 463

Hydroxypropyl cellulose

E 464

Hydroxypropyl methyl cellulose

E 465

Ethyl methyl cellulose

E 466

Carboxy methyl cellulose, Sodium carboxy methyl cellulose, Cellulose gum

E 322

Lecithins

quantum satis

Colours and fat-soluble antioxidants

E 432 – E 436

Polysorbates (Table 4 of Part 6)

E 470b

Magnesium salts of fatty acids

E 471

Mono- and diglycerides of fatty acids

E 472a

Acetic acid esters of mono- and diglycerides of fatty acids

E 472c

Citric acid esters of mono- and diglycerides of fatty acids

E 472e

Mono and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids

E 473

Sucrose esters of fatty acids

E 475

Polyglycerol esters of fatty acids

E 491 – E 495

Sorbitan esters (Table 5 of Part 6)

quantum satis

Colours and antifoaming agents

E 1404

Oxidised starch

quantum satis

All food additives

E 1410

Monostarch phosphate

E 1412

Distarch phosphate

E 1413

Phosphated distarch phosphate

E 1414

Acetylated distarch phosphate

E 1420

Acetylated starch

E 1422

Acetylated distarch adipate

E 1440

Hydroxy propyl starch

E 1442

Hydroxy propyl distarch phosphate

E 1450

Starch sodium octenyl succinate

E 1451

Acetylated oxidised starch

E 170

Calcium carbonate

E 263

Calcium acetate

E 331

Sodium citrates

E 332

Potassium citrates

E 341

Calcium phosphates

E 501

Potassium carbonates

E 504

Magnesium carbonates

E 508

Potassium chloride

E 509

Calcium chloride

E 511

Magnesium chloride

E 514

Sodium sulphates

E 515

Potassium sulphates

E 516

Calcium sulphate

E 517

Ammonium sulphate

E 577

Potassium gluconate

E 640

Glycine and its sodium salt

E 1505 (1)

Triethyl citrate

E 1518 (1)

Glyceryl triacetate (triacetin)

E 551

Silicon dioxide

quantum satis

Emulsifiers and colours

E 552

Calcium silicate

E 553b

Talc

50 mg/kg in the colour preparation

Colours

E 901

Beeswax, white and yellow

quantum satis

Colours

E 1200

Polydextrose

quantum satis

All food additives

E 1201

Polyvinylpyrrolidone

quantum satis

Sweeteners

E 1202

Polyvinylpolypyrrolidone

E 322

Lecithins

quantum satis

Glazing agents for fruit

E 432 – E 436

Polysorbates

E 470a

Sodium, potassium and calcium salts of fatty acids

E 471

Mono- and diglycerides of fatty acids

E 491 – E 495

Sorbitan esters

E 570

Fatty acids

E 900

Dimethyl polysiloxane

E 1521

Polyethylene glycol

quantum satis

Sweeteners

E 425

Konjac

quantum satis

All food additives

E 459

Beta-cyclodextrin

1 000 mg/kg in final food

All food additives

E 468

Crosslinked sodium carboxy methyl cellulose

Cross-linked cellulose gum

quantum satis

Sweeteners

E 469

Enzymatically hydrolysed carboxymethylcellulose

Enzymatically hydrolysed cellulose gum

quantum satis

All food additives

E 555

Potassium aluminium silicate

90 % relative to the pigment

In E 171 titanium dioxide and E 172 iron oxides and hydroxides

PART 2

Food additives other than carriers in food additives  (2)

E number of the added food additive

Name of the added food additive

Maximum level

Food additive preparations to which the food additive may be added

Table 1

 

quantum satis

All food additive preparations

E 200 – E 203

Sorbic acid — sorbates (Table 2 of Part 6)

1 500 mg/kg singly or in combination in the preparation 15 mg/kg in the final product expressed as the free acid

Colour preparations

E 210

Benzoic acid

E 211

Sodium benzoate

E 212

Potassium benzoate

E 220 – E 228

Sulphur dioxide — sulphites (Table 3 of Part 6)

100 mg/kg in the preparation and 2 mg/kg expressed as 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

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) (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

2 mg/kg in final food

In vitamin A and D preparations

E 475

Polyglycerol esters of fatty acids

quantum satis

In beta carotene, lutein, lycopene and vitamin E preparations

Yes

2 mg/kg in final food

In vitamin A and D preparations

E 491 – E 495

Sorbitan esters (Table 5 of Part 6)

quantum satis

In beta carotene, lutein, lycopene and vitamin E preparations

Yes

2 mg/kg in final food

In vitamin A and D preparations

E 500

Sodium carbonates

quantum satis

All nutrients

Yes

E 501

Potassium carbonates

quantum satis

All nutrients

Yes

E 503

Ammonium carbonates

quantum satis

All nutrients

Yes

E 504

Magnesium carbonates

quantum satis

All nutrients

Yes

E 507

Hydrochloric acid

quantum satis

All nutrients

Yes

E 508

Potassium chloride

quantum satis

All nutrients

 

E 509

Calcium chloride

quantum satis

All nutrients

 

E 511

Magnesium chloride

quantum satis

All nutrients

 

E 513

Sulphuric acid

quantum satis

All nutrients

 

E 514

Sodium sulphates

quantum satis

All nutrients

 

E 515

Potassium sulphates

quantum satis

All nutrients

 

E 516

Calcium sulphate

quantum satis

All nutrients

 

E 524

Sodium hydroxide

quantum satis

All nutrients

 

E 525

Potassium hydroxide

quantum satis

All nutrients

 

E 526

Calcium hydroxide

quantum satis

All nutrients

 

E 527

Ammonium hydroxide

quantum satis

All nutrients

 

E 528

Magnesium hydroxide

quantum satis

All nutrients

 

E 529

Calcium oxide

quantum satis

All nutrients

Yes

E 530

Magnesium oxide

quantum satis

All nutrients

Yes

E 551,

E 552

Silicon dioxide

Calcium silicate

50 000 mg/kg in the dry powdered preparation (singly or in combination)

In dry powdered preparations of all nutrients

 

10 000 mg/kg in the preparation (E 551 only)

In potassium chloride preparations used in salt substitutes

E 554

Sodium aluminium silicate

15 000 mg/kg in the preparation

In fat soluble vitamin preparations

 

E 570

Fatty acids

quantum satis

All nutrients except nutrients containing unsaturated fatty acids

 

E 574

Gluconic acid

quantum satis

All nutrients

 

E 575

Glucono-delta-lactone

quantum satis

All nutrients

 

E 576

Sodium gluconate

quantum satis

All nutrients

 

E 577

Potassium gluconate

quantum satis

All nutrients

 

E 578

Calcium gluconate

quantum satis

All nutrients

 

E 640

Glycine and its sodium salt

quantum satis

All nutrients

 

E 900

Dimethyl polysiloxane

200 mg/kg in the preparation, 0,2 mg/l in final food

In preparations of beta-carotene and lycopene

 

E 901

Beeswax, white and yellow

quantum satis

All nutrients

Yes, only as a carrier

E 938

Argon

quantum satis

All nutrients

 

E 939

Helium

quantum satis

All nutrients

 

E 941

Nitrogen

quantum satis

All nutrients

 

E 942

Nitrous oxide

quantum satis

All nutrients

 

E 948

Oxygen

quantum satis

All nutrients

 

E 949

Hydrogen

quantum satis

All nutrients

 

E 953

Isomalt

quantum satis

All nutrients

Yes, only as a carrier

E 965

Maltitol

quantum satis

All nutrients

Yes, only as a carrier

E 966

Lactitol

quantum satis

All nutrients

Yes, only as a carrier

E 967

Xylitol

quantum satis

All nutrients

Yes, only as a carrier

E 968

Erythritol

quantum satis

All nutrients

Yes, only as a carrier

E 1103

Invertase

quantum satis

All nutrients

 

E 1200

Polydextrose

quantum satis

All nutrients

Yes

E 1404

Oxidised starch

quantum satis

All nutrients

Yes

E 1410

Monostarch phosphate

quantum satis

All nutrients

Yes

E 1412

Distarch phosphate

quantum satis

All nutrients

Yes

E 1413

Phosphated distarch phosphate

quantum satis

All nutrients

Yes

E 1414

Acetylated distarch phosphate

quantum satis

All nutrients

Yes

E 1420

Acetylated starch

quantum satis

All nutrients

Yes

E 1422

Acetylated distarch adipate

quantum satis

All nutrients

Yes

E 1440

Hydroxy propyl starch

quantum satis

All nutrients

Yes

E 1442

Hydroxy propyl distarch phosphate

quantum satis

All nutrients

Yes

E 1450

Starch sodium octenyl succinate

quantum satis

All nutrients

Yes

E 1451

Acetylated oxidised starch

quantum satis

All nutrients

Yes

E 1452

Starch Aluminium Octenyl Succinate

35 000 mg/kg in final food

In food supplements as defined in Directive 2002/46/EC due to its use in vitamin preparations for encapsulation purposes only

Yes

E 1518

Glyceryl triacetate (triacetin)

 (8)

All nutrients

Yes, only as a carrier

E 1520 (8)

Propane-1, 2-diol (propylene glycol)

1 000 mg/kg in final food (as carry-over)

All nutrients

Yes, only as a carrier

Section B

Food additives added in nutrients intended to be used in foodstuffs for infants and young children listed in Point 13.1 of Part E of Annex II:

E number of the food additive

Name of the food additive

Maximum level

Nutrient to which the food additive may be added

Food category

E 301

Sodium ascorbate

Total carry-over 75 mg/l

Coatings of nutrient preparations containing polyunsaturated fatty acids

Foods for infants and young children

E 304 (i)

Ascorbyl palmitate

For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded

All nutrients

Foods for infants and young children

E 306

E 307

E 308

E 309

Tocopherol-rich extract

Alpha-tocopherol

Gamma-tocopherol

Delta-tocopherol

For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded

All nutrients

Foods for infants and young children

E 322

Lecithins

For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded

All nutrients

Foods for infants and young children

E 330

Citric acid

quantum satis

All nutrients

Foods for infants and young children

E 331

Sodium citrates

For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded and the conditions of use specified therein are respected

All nutrients

Foods for infants and young children

E 332

Potassium citrates

For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded and the conditions of use specified therein are respected

All nutrients

Foods for infants and young children

E 333

Calcium citrates

Total carry-over 0,1 mg/kg expressed as calcium and within the limit of calcium level and calcium/phosphorus ratio as set for the food category

All nutrients

Foods for infants and young children

E 341 (iii)

Tricalcium phosphate

Maximum level of 1 000 mg/kg expressed as 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’


(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.


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