EN    EN EN 
 SANCO/13103/2010EN 1   EN  EUROPEAN COMMISSION 
Brussels,  
 WORKING DOCUMENT ON Draft 
 COMMISSION REGULATION (EU) No  
of […] 
amending Annex III to Regulation (EC) No  1333/2008 of the European Parliament and 
of the Council on food additives by establishi ng  a Union list of food additives approved 
for use in food additives, food enzy mes, food flavourings and nutrients  
(Text with EEA relevance) EN 2   EN Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
amending  Annex III to Regulation (EC) No  1333/2008 of the European Parliament and 
of the Council on food additives by establis hing a Union list of food additives approved 
for use in food additives, food enzy mes, 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 
Community 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 la id 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 f unctional 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 Direc tive No 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 as their compliance with general 
conditions for inclusion and use of food additives in Community lists and 
particularly with Article 6( 1)(a) has been reviewed.  
                                                 
1 OJ L 354, 31.12.2008, p. 16. 
 
2  OJ L 61, 18.3.1995, p. 1. 
 EN 3   EN (4) Food additives listed as permitted carriers and carrier solvents in Directive No 
95/2/EC having a function as a food additiv e other than carrier, should be included 
in Part 2 of Annex III to Regulation (E C) No 1333/2008 with the same conditions 
of use. Other food additives having a func tion other than carri ers should also be 
included in this list. 
(5) Food additives and carriers authorised for us e in food enzymes as referred to in  
Regulation (EC) No 1332/2008 of the Europ ean Parliament and of the Council of 
16 December 2008 on enzymes and their conditions of use 3 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 No 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 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 a nd of certain other substances to foods4 
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 4, Directive 2009/39/EC of the European Parliament and of the 
Council of 6 May 2009 on foodstuffs inte nded for particular  nutritional uses 5, and 
Regulation (EC) No 953/2009 of the European  Parliament and of the Council of 6 
May 2009 on foodstuffs intended for particular nutritional uses 6, and their 
conditions of use should be included in Part 5 Section A of Annex III to Regulation (EC) No 1333/2008. Other food a dditives 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 for infants and young children by 
Directive No 95/2/EC and having a functi on 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 Scien tific Committee on Food on additives in 
nutrient preparations for us e in infant formulae, follow-on formulae and weaning 
food of 13 June 1997
7.  
                                                 
3  OJ L 354, 31.12.2008, p. 7. 
4  OJ L 183, 12.07.2002, p. 51. 
 
5  OJ L 404, 30.12.2006, p. 26.  
 
6  OJ L 269, 14.10.2009, p. 9. 
 
7 Opinion of the Scientific Committee on Food on Nutr ients on 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.
 
 EN 4   EN (9)  For the reasons of transparency and c onsistency specific rules for conditions of 
use of food additives in food additive/en zyme/nutrient preparation should be laid 
down.  
(10)  Substances like sulphites, benzoates, pol ysorbates, sorbitan esters and sucrose 
esters should be listed in Parts 1, 2, 3 and 5 of Annex III to Regulation (EC) No 
1333/2008; those substances are subject to tier 3 screeni ng according to  
Commission Report of 2001 on Dietary Food Additive Intake in the European 
Union 8  and are raising concerns  with respect to the ADI value. The conditions of 
use of those substances may be revised by European Food Safety Authority as a 
follow-up of the intake assessment estimated in the framework of the re-evaluation program as established by Regulation (EC) No 257/2010 setting up a program for 
the re-evaluation of approved additives
9. 
(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  
should be  taken over from Directives  2008/128/EC of 22 December 2008 laying 
down specific purity criteria concer ning colours for use in foodstuffs 10, 
2008/60/EC of 17 June 2008 laying down sp ecific purity criteria concerning 
sweeteners for use in foodstuffs 11 and 2008/84/EC laying down specific purity 
criteria on food additives othe r than colours and sweeteners 12. 
(12)  Due to the fact that some of preparations have been used since decades, a 
transitional period of twenty four months following the entry into force of this 
Regulation should be provided to enable th e food business operator s 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 Re gulation. A transitional period of six 
months following the entry into force of this Regula tion should be provided to 
enable the food business operato rs 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 Re gulation are in accordance with the opinion 
of the […] Committee, and neither the Eu ropean Parliament nor the Council has 
opposed them, 
   
 HAS ADOPTED THIS REGULATION: 
 
                                                 
 
9  OJ L 80, 26.3.2010, p. 19. 
 
10   OJ L 6, 10.1.2009, p. 20. 
 
11  OJ L 158, 18.06.2008, p. 17. 
 
12   OJ L 253, 20.09.2008, p. 1.  
 EN 5   EN Article 1 
 
Amendment to Regulation (EC) No 1333/2008 
Annex III to Regulation (EC) No 1333/2008 is re placed in accordance with the text in 
the Annex to this Regulation.  
  
Article 2 
Transitional measures 
Preparations not complying with Parts 2, 3 a nd/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 twenty four months from the date of en try into force of this Regulation. Foods 
containing such preparations that have been lawfully pl aced 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 Annexe s I to VI to Directive No 95/2/EC during 
a period of six months from the date of entry into force of this Regulation. Foods 
containing such preparations that have been lawfully pl aced 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 twentieth day following that of its publication in 
the Official Journal of  the European Union . It shall apply from […]. . 
 
This Regulation shall be binding in its entirety a nd directly applicable in the Member States in 
accordance with the Treaties. 
Done at Brussels, […] 
 For the Commission 
 José Manuel BARROSO  The President EN 6   EN ANNEX  
Annex III to Regulation (EC) No 1333/ 2008 is replaced by the following:  
"ANNEX III 
Union list of food additives including carrier s approved for use in food additives, food 
enzymes, food flavourings, nutrien ts and their conditions of use. 
 
Definitions: 
1."nutrients" means vitamins, minerals and othe r substances added for nutritional purposes, as 
well as for 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 A nnex 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 inco rporated to facilitate  their storage, sale, 
standardisation, dilu tion or dissolution. 
 
 Part 1 Carriers in food additives 
 
E No 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 * 
 Colours, emulsifiers and 
antioxidants 
E 422 Glycerol 
E 420 Sorbitol 
E 421 Mannitol 
E 953 Isomalt 
E 965 Maltitol 
E 966 Lactitol 
E 967 Xylitol 
E 968 Erythritol "Quantum satis" All food additives EN 7   EN E 400 – E 
404 Alginic acid – alginates (Table 7) 
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) "Quantum satis" Antifoaming agents 
E 442 Ammoniumphosphatides "Quantum satis" Antioxidants 
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 metyl cellulose 
  Cellulose gum 
E 462 Ethyl cellulose "Quantum satis" All food additives 
E 322 Lecithins 
E 432 - 436 Polysorbates (Table 4) 
E 470b Magnesium salts of fatty acids 
E 471 Mono- and diglycerides of fatty 
acids "Quantum satis" Colours and fat-soluble 
antioxidants 
 EN 8   EN 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 diacety 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 - 495 Sorbitan esters (Table 5) "Quantum satis" Colours and antifoaming 
agents 
E 1404 Oxidized starch 
E 1410 Monostarch phosphate 
E 1412 Distarch phosphate 
E 1413 Phospated 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 carbonates 
E 263 Calcium acetate 
E 331 Sodium citrates 
E 332 Potassium citrates 
E 341 Calcium phosphates 
E 501 Potassium carbonates "Quantum satis" All food additives EN 9   EN 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 salts 
E 1505* Triethyl citrate 
E 1518* Glyceryl triacetate (triacetin) 
E 551 Silicon dioxide 
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 
E 1202 Polyvinylpropylpyrrolidone "Quantum satis" 
 Sweeteners 
 
E 322 Lecithins 
E 432 - 436 Polysorbates 
E 470a Sodium, potassium and calcium 
salts of fatty acids 
E 471 Mono- and diglycerides of fatty 
acids 
E 491 - 495 Sorbitan esters 
E 570 Fatty acids "Quantum satis" Glazing agents for fruit 
 EN 10   EN E 900 Dimethyl polysiloxane 
 E 1521 Polyethylene glycol  "Quantum satis" Sweeteners 
E 425 Konjac "Quantum satis" All food additives 
E 459 Beta-cyclodextrin 1000 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 
 
*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.  
 
 EN 11   EN Part 2. Food additives other th an carriers in food additives*  
 
E No 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 - 203 Sorbic acid – sorbates  
(Table 3) 
E 210 Benzoic acid 
E 211 Sodium benzoate 
E 212 Potassium benzoate 1.500 mg/kg single or in 
combination in preparations 
15 mg/kg in final product 
expressed as the free acid Colour preparations 
E 220 - 228 Sulphur dioxide – sulphites 
(Table 3) 100 mg/kg in preparations 
and 2 mg/kg expressed as 
SO2 in final product as 
calculated  Colour preparations (except 
E163 anthocyanins, E 150 b 
caustic sulphite caramel and E 
150 d sulphite ammonia 
caramel)** 
E 320 Butylated hydroxyanisole 
(BHA) 
E 321 Butylated hydroxytoluene 
(BHT) 20 mg/kg single or in 
combination (expressed on 
fat) in the preparation, 0,4 
mg/kg in final product 
(single or in combination) emulsifiers containing fatty acids  
E 338 Phosphoric acid 
E 339 Sodium phosphates 
E 340 Potassium phosphates 
E 343 Magnesium phosphates 
E 450 Diphosphates 
E 451 Triphosphates 40.000 mg/kg single or in 
combination in preparations 
(expressed as P2O5) Preparations of the colour E 163 
anthocyanins 
E 341 
 Calcium phosphates 
 40.000 mg/kg in 
preparations (expressed as 
P2O5)  colour and emulsifier 
preparations  EN 12   EN 10.000 mg/kg in 
preparations (expressed as 
P2O5) polyol preparations 
10.000 mg/kg in 
preparations (expressed as 
P2O5) E 412 guar gum preparations 
E 392 Extracts of rosemary 1.000 mg/kg in 
preparations, 5 mg/kg in 
final product expressed as 
the summary of carnosoic 
acid and carnosol Colour preparations 
E 416 Karaya gum 50.000 mg/kg in 
preparations, 1 mg/kg in 
final product Colour preparations  
E 432-436 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 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), EN 13   EN E 491-495 Sorbitan esters 
 Table 5 'Quantum satis'  Preparations of colours , anti-
foaming agent preparations and 
glazing agents for fruit 
50.000 mg/kg in 
preparations Dry powdered colour 
preparations E 551 Silicon dioxide 
10.000 mg/kg in 
preparations E 508 potassium chloride and  
E 412 guar gum preparations 
E 551 Silicon dioxide 
E 552 Calcium silicate 50.000 mg/kg in 
preparations Dry powdered preparations of 
emulsifiers 
E 551 Silicon dioxide 
E 552 Calcium silicate 
E 553a Magnesium silicate 
E 553b Talc 10.000 mg/kg in 
preparations Dry powdered preparations of 
polyols 
E 900 Dimethyl polysiloxane 200 mg/kg in preparations, 
0,2 mg/l in final food.  Colour preparations of E 160 a 
carotens, 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 
preparations, 1200 mg/kg in 
final product from all 
sources. As stabiliser in preparations of 
sweeteners and /or acids 
intended to be used in chewing 
gum 
*=except enzymes currently authorised as food additives  
**=E 163 anthocyanins may contain up to 100.000 mg/kg sulphites. E 150 b caustic sulphite 
caramel and E 150 d sulphite ammonia caram el may contain 2000 mg/kg according to the 
purity criteria (Directive 2008/128/EC) 
Note: General rules for conditions of use of Food additives in part 2:  
(1) Food Additives listed in food additives ge nerally permitted fo r use in foodstuffs 
not referred in Article 2 (3 ) of Directive 95/2/EC (by derogation of  E 920 (L-EN 14   EN cysteine)), presented in Table 1 of this  Annex, are used as  food additives (not 
carriers) under the general 'Quantum satis' principle, unless differently stated,  
(2) For phosphates and silicates maximum limits were set only in food additive 
preparation and not in final food. 
(3) For all other food additives with a num erical ADI value maximum limits were 
set for food additive/enzyme/nutrient pr eparation and the final food as well. 
(4) No food additives are authorised for th eir function as colour, sweetener of 
flavour enhancer.  EN 15   EN Part 3: Food additives includi ng carriers in food enzymes*    
E No of 
the added 
food 
additive Name of the added  food 
additives  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 
E 202 Potassium sorbate 20.000 mg/kg 
(single or in 
combination 
expressed as the 
free acid) 
 20 mg/kg 
  10 mg/l 
   
E 210 Benzoic acid 
E 211 Sodium benzoate 5.000 mg/kg (single 
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 214 Ethyl-p-hydroxybenzoate 
E 215 Sodium ethyl p-
hydroxybenzoate 
E 218 Methyl p-hydroxybenzoate 
E 219 Sodium methyl p-
hydroxybenzoate 2.000 mg/kg (single 
or in combination 
expressed as the 
free acid) 
   2 mg/kg 
  
  
   1 mg/l 
  
  
   
E 220 Sulphur dioxide 
E 221 Sodium sulphite 
E 222 Sodium hydrogen sulphite 
E 223 Sodium metabisulphite 
E 224 Potassium metabisulphite 2.000 mg/kg (single 
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 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 100.000 mg/kg 100 mg/kg 50 mg/L  EN 16   EN 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 
E 340 Potassium phosphates 
E 341 Calcium phosphates 
E 343 Magnesium phosphates 50.000 mg/kg 
(single or in 
combination, 
expressed as P2O5) 'Quantum 
satis'? 'Quantum 
satis'? Yes 
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 eucheuma 
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 EN 17   EN 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 
E 451 Triphosphates 
E 452 Polyphosphates 50.000 mg/kg 
(single or in 
combination 
expressed as 
P2O5)  'Quantum satis' 'Quantum satis'  
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 EN 18   EN 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'  EN 19   EN 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 Oxidized 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  500 mg/kg 250 mg/L Yes, only 
as a 
carrier 
*=including enzymes currently authorised as food additives 
**=maximum level from all sources] in foodstuffs 3.000 mg/kg (individually or in combination with 
E 1505, E 1517 and E 1518) . In the case of beverages, with th e exception of cream liqueurs, the 
maximum level of E 1520 shall be 1.000 mg/l from all sources 
 
Note: General rules for conditions of use of Food additives in part 3:  
1. Food Additives listed in food additives gene rally permitted for use in foodstuffs not 
referred in Article 2 (3) of Directive 95/2/EC (by derogati on of  E 920 (L-cysteine)), 
presented in Table 1 of this Annex, are used  as food additives (not  carriers) under the 
general 'Quantum satis' principle, unless differently stated,  
2. For phosphates and silicates, when used as a dditives, maximum limits were set only in 
food enzyme/ preparation and not in final food. 
3. For all other food additives with a numerical ADI value maximum limits were set for 
food additive/enzyme/nutrient preparation and the final food as well. 
4. No food additives are authorised for their function as colour, sweetener of flavour 
enhancer.  
 EN 20   EN Part 4 Food additives including  carriers in food flavourings:  
 
E No 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 
Erythrytol All Flavourings  "Quantum satis" for 
purposes other than 
sweetening, not as 
flavour enhancers 
E 200- 203  
E 210 
E 211 
E 212 
E 213 Sorbic acid and sorbates,  
(Table 2),  
Benzoic acid,  
Sodium benzoate,  
Potassium benzoate  
Calcium benzoate All Flavourings 1.500 mg/kg (single or in 
combination expressed as 
the free acid) in 
flavourings 
Essential oils  1 000 mg/kg (gallates, 
TBHQ and BHA, 
individually or in 
combination) in the 
essential oils E 310 
E311 
E 312 
E 319 
 
E 320 Propyl gallate 
Octyl gallate 
Dodecyl gallate 
Tertiary-butyl hydroquinone 
(TBHQ) 
Butylated hydroxyanisole 
(BHA) Flavourings other than 
essential oils  100 mg/kg* (gallates, 
individually or in 
combination) 
200 mg*/kg (TBHQ and 
BHA, 
individually or in 
combination) in 
flavourings  
E 338 – 452 Phosphoric acid - phosphates - 
di - tri-  and polyphosphates 
(Table 6) All Flavourings 40.000 mg/kg (single 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 Konjak All Flavourings "Quantum satis" 
All Flavourings, except liquid 
smoke flavourings and 
flavourings based on spice 
oleoresins (**)  
 
10.000 mg/kg in 
flavourings E 432 –E 436 Polysorbates (Table 4)  
Foodstuffs containing liquid 
smoke 
flavourings and flavourings 
based on spice oleoresins 
1.000 mg/kg in final food EN 21   EN Encapsulated flavourings in: 
— flavoured teas and 
flavoured powdered instant 
drinks 500 mg/l in final food E 459 Beta-cyclodextrin 
— 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 
E 1517 Glyceryl diacetate (diacetin) 
E 1518 Glyceryl triacetate (triacetin) 
E 1520 Propane-1, 2-diol (propylene 
glycol) 
All Flavourings 3.000 mg/kg from all 
sources in foodstuffs as 
consumed or as 
reconstituted according to 
the instructions of the 
manufacturer; 
individuallyor 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.  
Flavourings for:  
— liqueurs, aromatised wines, 
aromatised wine-based drinks 
and aromatised wine-products 
cocktails 100 mg/l in final food E 1519 
  
  Benzyl alcohol 
  
  
— confectionery including 
chocolate and fine bakery 
wares 250 mg/kg from all 
sources in foodstuffs as 
consumed or as 
reconstituted according to 
instruction of the 
manufacturer 
 
The * in the table refers to the proportionality rule : when combinations of gallates, TBHQ, and BHA are 
used, the individual levels must be reduced proportionally. 
** Spice oleoresins are defined as extracts of spices fr om which the extraction solvent has been evaporated 
leaving a mixture of the volatile oil and resinous material from the spice. EN 22   EN  
Part 5 Food additives in nutrients  
 
 
Section A: FOOD ADDITIVES IN NUTRIE NTS EXCEPT NUTRIENTS INTENDED TO 
BE USED IN FOODSTUFFS FOR INFANT S AND YOUNG CHILDREN LISTED IN 
POINT 13.1 OF PART E OF ANNEX II 
 
E No 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  EN 23   EN 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 -452  Table 6 ( Phosphoric acid 
- Phosphates - Di-, tri-and 
polyphosphates)  40.000 mg/kg 
expressed as P2O5 
in nutrient 
preparations 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 
preparations of beta-
carotene and 
lycopene, 5 mg/kg 
in final product 
expressed as the 
summary of 
carnosoic acid and 
carnosol   
E 400 – E 404 Alginic acid – alginates 
(Table 7) 'Quantum satis' All nutrients Yes 
E 406 Agar 'Quantum satis' All nutrients Yes 
E 407 Carrageenan 'Quantum satis' All nutrients Yes 
E 407a Processed eucheuma 'Quantum satis' All nutrients Yes EN 24   EN seaweed 
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 432-436 Polysorbates (Table 4) '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    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 
product 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 EN 25   EN 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 
'Quantum satis' 
 In beta carotene, lutein, 
lycopene and vitamin E 
preparations.  E 473 Sucrose esters of fatty 
acids 
2 mg/kg in final 
food  In vitamin A and D 
preparations  Yes EN 26   EN 'Quantum satis' 
 In beta carotene, lutein, 
lycopene and vitamin E 
preparations.  E 475 Polyglycerol esters of 
fatty acids 
2 mg/kg in final 
food  In vitamin A and D 
preparations  Yes 
'Quantum satis' 
 In beta carotene, lutein, 
lycopene and vitamin E 
preparations.  E 491 - 495 Sorbitan esters (Table 
5) 
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 EN 27   EN 50.000 mg/kg in the 
dry powdered 
preparation (single 
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 Max. 15.000 mg/kg 
in preparations  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 
preparations, 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 EN 28   EN 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 Oxidized 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/EC13due to its 
use in vitamin 
preparations for Yes 
                                                 
13  OJ L 183, 12.7.2002, p.51 
 EN 29   EN encapsulation purposes 
only 
E 1518* Glyceryl triacetate 
(triacetin) Max. 3.000 mg/kg 
in final food All nutrients Yes, only as 
a carrier 
E 1520* Propane-1, 2-diol 
(propylene glycol) Max.1.000 mg/kg in 
final food All nutrients Yes, only as 
a carrier 
 
*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 15 20 shall be 1.000 mg/l from all sources  
 
Section B: FOOD ADDITIVE S ADDED IN NUTRIENTS INTENDED TO BE USED IN 
FOODSTUFFS FOR INFANTS AND YOUNG CH ILDREN LISTED IN POINT 13.1 OF 
PART E OF ANNEX II." 
 
E No 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 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 Total carry-over 0,5 
mg/kg  All nutrients Foods for infants 
and young children EN 30   EN E 330 Citric acid Total carry-over 0,1 
mg/kg  All nutrients Foods for infants 
and young children 
E 331 Sodium citrate Total carry-over 0,1 
mg/kg expressed as 
Sodium All nutrients Foods for infants 
and young children 
E 332 Potassium citrate Total carry-over 0,1 
mg/kg expressed as 
Potassium All nutrients Foods for infants 
and young children 
E 333 Calcium citrate Total carry-over 0,1 
mg/kg expressed as 
Calcium All nutrients Foods for infants 
and young children 
E 341iii Tricalcium 
phosphate Maximum level of 
1.000 mg/kg as P2O5 
from all uses in final 
food should be 
respected (only for E 
341 iii with a 
provision on a 
maximum level on 
aluminium) All nutrients Processed cereal 
based foods and 
baby foods for 
infants and young 
children in good 
health 
E 401 Sodium 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 in good 
health 
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 in good 
health 
E 404 Calcium 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 in good 
health EN 31   EN E 414 Gum arabic (acacia 
gum) 150.000 mg/kg in 
nutrient preparations 
and 10 mg/kg carry-
over in final product.  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 of Part E 
of Annex II is not 
exceeded All nutrients Processed cereal 
based foods and 
baby foods for 
infants and young 
children in good 
health 
E 421 Mannitol 1.000 times more 
than vitamin B12,   
3 mg/kg total carry-
over  As carrier for biotin  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 in good 
health 
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/EC14 
Total carry-over 
4.000 mg/l  All nutrients Infant formulae and 
follow-on formulae 
for infants and 
young children in 
good health E 471 Mono- and 
diglycerides of 
fatty acids 
Total carry-over 
5.000 mg/kg  All nutrients In processed cereal 
based foods and 
baby foods for 
infants and young 
children in good 
health 
                                                 
14  OJ L 91, 7.4.1999, p. 29 EN 32   EN 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 g/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 of Part E 
of Annex II is not 
exceeded All nutrients Processed cereal 
based foods and 
baby foods for 
infants and young 
children in good 
health 
Carry-over 100 
mg/kg  Vitamin preparations  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 of Part E 
of Annex II is not 
exceeded All nutrients Processed cereal 
based foods and 
baby foods for 
infants and young 
children in good 
health 
 
Note: General rules for conditions of use of Food additives in part 5  
1. Food Additives listed in food additives ge nerally permitted for use in foodstuffs 
not referred in Article 2 (3) of Directiv e 95/2/EC (by derogation of  E 920 (L-
cysteine)), presented in Table 1 of pa rt 6 of this Annex, are used as food 
additives (not carriers) under the general 'Quantum satis' principle, unless differently stated. 
2. For phosphates and silicates, when used as  additives, maximum limits were set 
only in food nutrient preparat ion and not in final food. 
3. For all other food additives with a numerical ADI value maximum limits were set 
for food additive/enzyme/nutrient preparation and the final food as well. EN 33   EN 4. No food additives are authorised for thei r function as colour, sweetener of flavour 
enhancer.  
 
 
PART 6:  Definitions of groups of food additives for the purposed of Parts 1 to 5  
Table 1: List of  food additives authorised to  be used as food additives or carriers under 
the 'Quantum satis' principle (e xcept from Part 5 Section B).  
 
E No  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 EN 34   EN E 401 Sodium alginate 
E 402 Potassium alginate 
E 403 Ammonium alginate 
E 404 Calcium alginate 
E 406 Agar 
E 407 Carrageenan 
E 407a Processed eucheuma seaweed 
E 410 Locust bean gum  
E 412 Guar gum  
E 413 Tragacanth 
E 414 Acacia gum (gum arabic) 
E 415 Xanthan gum  
E 417 Tara gum  
E 418 Gellan gum 
E 422 Glycerol 
E 440 Pectins 
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 EN 35   EN 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 Oxidized starch 
E 1410 Monostarch phosphate 
E 1412 Distarch phosphate 
E 1413 Phosphated distarch phosphate 
E 1414 Acetylated distarch phosphate 
E 1420 Acetylated starch 
E 1422 Acetylated distarch adipate 
E 1440 Hydroxy propyl starch 
E 1442 Hydroxy propyl distarch phosphate 
E 1450 Starch sodium octenyl succinate 
E 1451 Acetylated oxidised starch 
 
Table 2:  Sorbic acid -  Sorbates  
E-number Name 
E 200 Sorbic acid 
E 202 Potassium sorbate 
E 203 Calcium sorbate 
 EN 36   EN 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 m onolaurate (polysorbate 20) 
E 433 Polyoxyethylene sorbitan monooleate (polysorbate 80) 
E 434 Polyoxyethylene sorbitan m onopalmitate (polysorbate 40) 
E 435 Polyoxyethylene sorbitan monostearate (polysorbate 60) 
E 436 Polyoxyethylene sorbitan monot ristearate (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 
 EN 37   EN  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 Alginic Acid -Alginates
E 400 Alginic acid 
E 401 Sodium alginate 
E 402 Potassium alginate 
E 403 Ammonium alginate