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
Date: 2011-11-11
Institutions: European Commission
Subjects: enzyme, food additive, food safety, food standard, human nutrition, market approval, processed food product, processed foodstuff




L_2011295EN.01017801.xml










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.