This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents  
►B COMMISSION REGULATION (EU) No 231/2012  
of 9 March 2012  
laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 
1333/2008 of the European Parliament and of the Council  
(Text with EEA relevance)  
(OJ L 83, 22.3.2012, p. 1)  
Amended by:  
Official Journal  
No page  date  
►M1 Commission Regulation (EU) No 1050/2012 of 8 November 2012  L 310  45  9.11.2012  
►M2 Commission Regulation (EU) No 25/2013 of 16 January 2013  L 13  1  17.1.2013  
►M3 Commission Regulation (EU) No 497/2013 of 29 May 2013  L 143  20  30.5.2013  
►M4 Commission Regulation (EU) No 724/2013 of 26 July 2013  L 202  11  27.7.2013  
►M5 Commission Regulation (EU) No 739/2013 of 30 July 2013  L 204  35  31.7.2013  
►M6 Commission Regulation (EU) No 816/2013 of 28 August 2013  L 230  1  29.8.2013  
►M7 Commission Regulation (EU) No 817/2013 of 28 August 2013  L 230  7  29.8.2013  
►M8 Commission Regulation (EU) No 1274/2013 of 6 December 2013  L 328  79  7.12.2013  
►M9 Commission Regulation (EU) No 264/2014 of 14 March 2014  L 76  22  15.3.2014  
►M10  Commission Regulation (EU) No 298/2014 of 21 March 2014  L 89  36  25.3.2014  
►M11  Commission Regulation (EU) No 497/2014 of 14 May 2014  L 143  6  15.5.2014  
►M12  Commission Regulation (EU) No 506/2014 of 15 May 2014  L 145  35  16.5.2014  
►M13  Commission Regulation (EU) No 685/2014 of 20 June 2014  L 182  23  21.6.2014  2012R0231 — EN — 11.07.2014 — 008.001 — 1
COMMISSION REGULATION (EU) No 231/2012  
of 9 March 2012  
laying down specifications for food additives listed in Annexes II 
and III to Regulation (EC) No 1333/2008 of the European 
Parliament and of the Council  
(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 14 and 30(4) thereof, and Regu ­
lation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (
 2 ), 
and in particular Article 7(5) thereof,  
Whereas:  
(1) Specifications relating to origin, purity criteria and any other 
necessary information should be adopted for food additives listed in the Union lists in Annex II and III to Regulation (EC) No 1333/2008.
 
(2) To that end, specifications previously developed for food 
additives in Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs (
 3 ), Commission Directive 2008/84/EC of 
27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (
 4 ) and Commission 
Directive 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs (
 5 ) 
should be updated and taken over to this Regulation. As a consequence, those Directives should be repealed.
 
(3) It is necessary to take into account the specifications and 
analytical techniques as set out in the Codex Alimentarius drafted by the Joint FAO/WHO Expert Committee on Food Additives (hereafter JECFA).
 
(4) The European Food Safety Authority (hereinafter ‘the Authority’) 
expressed its opinion on the safety of basic methacrylate copolymer (
 6 ) as a glazing agent. That food additive has 
subsequently been authorised on the basis of specific uses and has been allocated the number E 1205. Therefore specifications should be adopted for that food additive.  ▼
B 2012R0231 — EN — 11.07.2014 — 008.001 — 2  
( 1 ) OJ L 354, 31.12.2008, p. 16. 
( 2 ) OJ L 354, 31.12.2008, p. 1. 
( 3 ) OJ L 6, 10.1.2009, p. 20. 
( 4 ) OJ L 253, 20.9.2008, p. 1. 
( 5 ) OJ L 158, 18.6.2008, p. 17. 
( 6 ) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); 
Scientific Opinion on the use of Basic Methacrylate Copolymer as a food additive on request from the European Commission.  EFSA Journal  2010; 
8(2):1513.
 (5) Food colours ethyl ester of beta-apo-8'-carotenic acid (E 160 f), 
and brown FK (E 154), as well as the aluminium containing carrier bentonite (E 558) are not used any more according to information submitted by food manufacturers. Therefore, current specifications for those food additives should not be taken over to this Regulation.
 
(6) On 10 February 2010 the Authority expressed an opinion on the 
safety of sucrose esters of fatty acids (E 473) prepared from vinyl esters of fatty acids (
 1 ). Current specifications should be adapted 
accordingly in particular by reducing maximum limits for impurities of safety concern.
 
(7) Specific purity criteria currently applicable should be adapted by 
reducing maximum limits for individual heavy metals of interest where feasible and where the JECFA limits are lower than those 
currently in force. Pursuant to that approach maximum limits for 
the contaminant 4-methylimidazole in ammonia caramel (E 150 c), sulphated ash in beta-carotene (E 160 a (i)), and magnesium and alkali salts in calcium carbonate (E 170), should be lowered. That approach should be departed from only for additives trisodium citrate (E 331 (iii)) (lead content), carrageenan (E 407) and processed euchema seaweed (E407 a) (cadmium content), as manufacturers have declared that compliance with stricter Union provisions, reflecting JECFA limits, would not be technically feasible. The contribution to the total intake of those two contaminants (lead and cadmium) in those three indi ­
vidual food additives is not considered to be significant. On the contrary for phosphates (E 338-E 341 and E 450-E 452) new significantly lower values, compared to the ones indicated by JECFA, should be established due to new developments of the manufacturing processes, by taking into account the recent recommendations of the Authority on a reduction of the intake 
of arsenic, especially in the inorganic form (
 2 ). In addition, a new 
provision on arsenic for glutamic acid (E 620) should be introduced for safety reasons. The total balance of those adap ­
tations benefits the consumers as maximum limits for heavy metals are becoming stricter in general and in most of the food additives. Detailed information on the production process and starting materials of a food additive should be included in the specifications to facilitate any future decision pursuant to Article 12 of Regulation (EC) No 1333/2008.
 
(8) Specifications should not make reference to organoleptic tests 
related to the taste as it cannot be expected by the control auth ­
orities to take the risk to taste a chemical substance.  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 3  
( 1 ) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); 
Scientific Opinion on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of 
fatty acids in flavourings on request from the European Commission.  EFSA 
Journal  2010; 8(3):1512. 
(
 2 ) EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific 
Opinion on Arsenic in Food.  EFSA Journal  2009; 7(10):1351.
 (9) Specifications should not make reference to classes as there is no 
added value in this reference.  
(10) Specifications should not make reference to the general parameter 
‘Heavy metals’ as this parameter does not relate with toxicity, but rather with a generic analytical method. Parameters related to 
individual heavy metals are toxicity related and are included in 
the specifications.
 
(11) Some food additives are currently listed under various names 
(carboxy methyl cellulose (E 466), cross-linked sodium carboxy ­
methylcellulose (E 468), enzymatically hydrolised carboxy ­
methylcellulose (E 469) and beeswax, white and yellow (E 901)) in various provisions of Directive 95/2/EC of the European Parliament and of the Council (
 1 ). Therefore the spec ­
ifications established by this Regulation should refer to those various names.
 
(12) Current provisions on Polycyclic Aromatic Hydrocarbons (PAHs) 
are too generic and not relevant to safety and should be replaced 
by maximum limits for individual PAHs of concern for food additives vegetable carbon (E 153) and microcrystalline wax (E 905). Similar maximum limits should be established for formal ­
dehyde in carageenan (E 407) and processed euchema seaweed (E 407 a), for particular microbiological criteria in agar (E 406) and for  Salmonella  spp. content in mannitol (E 421 (ii)) manu ­
factured by fermentation.
 
(13) The use of propan-2-ol (isopropanol, isopropyl alcohol) should be 
allowed for manufacturing the additives curcumin (E 100) and paprika extract (E 160 c), in line with JECFA specifications, as this particular use has been considered safe by the Authority (
 2 ). 
The use of ethanol in replacement of propan-2-ol in the manu ­
facturing of gellan gum (E 418) should be permitted where the 
final product still complies with all other specifications and 
ethanol is considered to be of less safety concern.  
(14) The percentage of the colouring principle in cochineal, carminic 
acid, carmines (E 120) should be specified, as maximum limits are to apply to quantities of that principle.
 
(15) The numbering system for subcategories of carotenes (E 160 a) 
should be updated in order to bring it in line with the Codex Alimentarius numbering system.
 
(16) The solid form of lactic acid (E 270) should also be included in 
the specifications, as it can now be manufactured in the solid 
form and there is no safety concern.  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 4  
( 1 ) OJ L 61, 18.3.1995, p. 1. 
( 2 ) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); 
Scientific Opinion on the re-evaluation of curcumin (E 100) as a food additive.  EFSA Journal  2010; 8(9):1679.
 (17) The current temperature value in loss on drying for monosodium 
citrate (E 331 (i)), anhydrous form should be adjusted as under the currently listed conditions the substance decomposes. Drying conditions for trisodium citrate (E 331 (iii)) should also be adjusted to improve the reproducibility of the method.
 
(18) The current specific absorption value for alpha-tocopherol (E 
307) should be corrected and the sublimation point for sorbic acid (E 200) should be replaced by a ‘solubility test’ as the former is not relevant. The specification of bacterial sources for the manufacturing of nisin (E 234) and natamycin (E 235) should be updated according to the current taxonomic nomenclature.
 
(19) As new innovative manufacturing techniques resulting in less 
contaminated food additives are now available, the presence of aluminium in food additives should be restricted. In order to enhance legal certainty and non-discrimination it is appropriate to provide the manufacturers of food additives with a transitional period to adapt gradually to those restrictions.
 
(20) Maximum limits for aluminium should be established for food 
additives where relevant, and particularly for calcium phosphates (E 341 (i)-(iii)) intended to be used in food for infants and young children (
 1 ), according to the relevant opinion of Scientific 
Committee on Food expressed on 7 June 1996 (  2 ). In this 
framework a maximum limit for aluminum in calcium citrate (E 333) should also be established.
 
(21) The maximum limits for aluminium in calcium phosphates (E 
341 (i)-(iii)), disodium diphosphate (E 450 (i)) and calcium dihy ­
drogen diphosphate (E 450 (vii)) should be in accordance with 
the opinion of the Authority of 22 May 2008 (  3 ). Current limits 
should be reduced, where this is technically feasible, and where the contribution to the total aluminium intake is significant. In this framework aluminium lakes of individual food colours should be authorised only if technically needed.
 
(22) Provisions on maximum limits for aluminium in dicalcium 
phosphate (E 341 (ii)), tricalcium phosphate (E 341 (iii)) and calcium dihydrogen diphosphate (E 450 (vii)) should not cause any disruption of the market, due to a possible lack of supplies.  ▼
B 2012R0231 — EN — 11.07.2014 — 008.001 — 5  
( 1 ) As defined in Commission Directive 2006/125/EC of 5 December 2006 on 
processed cereal-based foods and baby foods for infants and young children (codified version), OJ L 339, 6.12.2006, p. 16. 
(
 2 ) Opinion on Additives in nutrient preparations for use in infant formulae, 
follow-on formulae and weaning foods. Reports of the Scientific 
Committee on food (40th Series), p. 13-30, (1997). 
( 3 ) Scientific Opinion of the Panel on Food Additives, Flavourings, Processing 
Aids and Food Contact Materials on a request from European Commission on Safety of aluminium from dietary intake.  EFSA Journal  (2008) 754, 1-34.
 (23) According to Commission Regulation (EU) No 258/2010 of 
25 March 2010 imposing special conditions on the imports of guar gum originating in or consigned from India due to contami ­
nation risks by pentachlorophenol and dioxins (
 1 ), maximum 
limits should be set for the contaminant pentachlorophenol in guar gum (E 412).
 
(24) According to recital 48 of Commission Regulation (EC) No 
1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (
 2 ) Member States are 
requested to examine other foodstuffs than the ones included in that Regulation for the occurrence of contaminant 3-MCPD in order to consider the need to set maximum levels for that substance. French authorities have submitted data on high concentrations of 3-MCPD in the food additive glycerol (E 422) and the average use level of this food additive in various 
food categories. Maximum limits for 3-MCPD in this particular 
food additive should be set in order to avoid contamination of the final food at a higher than permissible level, taking into account the dilution factor.
 
(25) Due to the development of analytical methods certain current 
specifications should be updated. The current limit value ‘not detectable’ is linked to the evolution of analytical methodologies 
and should be replaced by a specific number for additives acid 
esters of mono- and diglycerides (E 472 a-f), polyglycerol esters of fatty acids (E 475) and propane-1,2-diol esters of fatty acids (E 477).
 
(26) Specifications relating to the manufacturing procedure should be 
updated for citric acid esters of mono- and diglycerides of fatty acids (E 472 c), as the use of alkaline bases is replaced today by 
the use of their milder acting salts.
 
(27) The current criterion ‘free fatty acids’ for additives citric acid 
esters of mono- and diglycerides of fatty acids (E 472 c) and mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids (E 472 e) is not appropriate. It should be replaced by the criterion ‘acid value’ as the latter expresses better the titrimetric estimation of the free acidic groups. This is in 
accordance with the 71st report on food additives from 
JECFA (
 3 ) where such change was adopted for mono- and diace ­
tyltartaric acid esters of mono- and diglycerides of fatty acids (E 472 e).
 
(28) The current erroneous description of additive magnesium oxide 
(E 530) should be corrected according to information submitted by the manufacturers, in order to bring it in line with the Phar ­
macopoeia Europea (
 4 ). The current maximum value for the 
reducing matter in additive gluconic acid (E 574) should also  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 6  
( 1 ) OJ L 80, 26.3.2010, p. 28. 
( 2 ) OJ L 364, 20.12.2006, p. 5. 
( 3 ) WHO Technical Report Series, No 956, 2010. 
( 4 ) EP 7.0 volume 2, p. 2415-2416.
 be updated as this limit is not technically feasible. For the esti ­
mation of the water content of xylitol (E 967) the current method based on ‘loss on drying’, should be replaced by a more appro ­
priate method.
 
(29) Some current specifications for additive candelilla wax (E 902) 
should not be taken over to this Regulation since they are erratic. For calcium dihydrogen diphosphate (E 450 (vii)) the current entry concerning P
 2 O 5 content should be corrected.  
(30) In the current entry ‘assay’ for thaumatin (E 957) a calculation 
factor should be corrected. That factor is to be used in the Kjeldahl method for the estimation of the total content of the substance based on the measurement of nitrogen. The calculation factor should be updated according to the relevant published literature for thaumatin (E 957).
 
(31) The Authority evaluated the safety of steviol glycosides, as a 
sweetener and expressed its opinion of 10 March 2010 (  1 ). The 
use of steviol glycosides, which have been allocated number E 960, has subsequently been permitted on the basis of well defined conditions of use. Therefore specifications should be adopted for this food additive.
 
(32) Due to a taxonomic change, current specifications for source 
materials (yeasts) used in the manufacturing of erythritol (E 
968) should be updated.  
(33) For quillaia extract (E 999) the current specification relating to 
the pH range should be adjusted in order to bring it in line with JECFA.
 
(34) The combination of citric acid and phosphoric acid (which are 
currently both individually authorised for use in the manufac ­
turing of additive polydextrose (E 1200)), should be allowed, where the final product still complies with the purity specifi ­
cations, as it improves yields and results to more controllable reaction kinetics. There is no safety concern involved in such amendment.
 
(35) Unlike for small molecules, the molecular mass of a polymer is 
not one unique value. A given polymer may have a distribution of molecules with different masses. The distribution may depend on the way the polymer is produced. Polymer physical properties and behaviors are related to the mass and to the distribution of molecules with a certain mass in the mixture. A group of math ­
ematical models describe the mixture in different ways in order to clarify the distribution of molecules in the mixture. Among the different models available, it is recommended in scientific literature to use the weight average molecular weight (Mw) to describe polymers. The specifications for polyvinylpyrrolidone (E 1201) should be adjusted accordingly.  ▼
B 2012R0231 — EN — 11.07.2014 — 008.001 — 7  
( 1 ) EFSA Panel on Food Additives and Nutrient Sources (ANS); Scientific 
Opinion on the safety of steviol glycosides for the proposed uses as a food additive.  EFSA Journal  (2010); 8(4):1537.
 (36) The criterion ‘Distillation range’ referred to in current specifi ­
cations for propane-1,2 diol (E 1520) leads to contradictory conclusions compared to results from the assay. That criterion should therefore be corrected and renamed into ‘Distillation test’.
 
(37) 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  
Specifications for food additives  
Specifications for food additives including colours and sweeteners listed 
in Annex II and III to Regulation (EC) No 1333/2008 are laid down in 
the Annex to this Regulation.  
Article 2  
Repeals  
Directives 2008/60/EC, 2008/84/EC and 2008/128/EC are repealed with 
effect from 1 December 2012.  
Article 3  
Transitional measures  
Foodstuffs containing food additives that have been lawfully placed on 
the market before 1 December 2012, but do not comply with this Regulation, may continue to be marketed until stocks are exhausted.
 
Article 4  
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 1 December 2012.  
However, the specifications laid down in the Annex for additives steviol 
glycosides (E 960) and basic methacrylate copolymer (E 1205) shall apply from the date of entry into force of this Regulation.
 
This Regulation shall be binding in its entirety and directly applicable in 
the Member States.  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 8
 
ANNEX  
Note : Ethylene oxide may not be used for sterilising purposes in food additives  
Aluminium lakes for use in colours only where explicitly stated. 
Definition:  Aluminium lakes are prepared by reacting colours complying with 
the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium 
sulphate or chloride with sodium or calcium carbonate or bicar ­
bonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product.
 
HCl insoluble matter  Not more than 0,5 %  
ΝaΟΗ insoluble matter  Νot more than 0,5 %, for Ε 127 erythrosine only  
Ether extractable matter  Not more than 0,2 % (under neutral conditions) 
Specific purity criteria for the corresponding colours are applicable.  
E 100 CURCUMIN 
Synonyms  CI Natural Yellow 3; Turmeric Yellow; Diferoyl Methane  
Definition  Curcumin is obtained by solvent extraction of turmeric i.e. the 
ground rhizomes of strains of  Curcuma longa  L. In order to 
obtain a concentrated curcumin powder, the extract is purified by 
crystallization. The product consists essentially of curcumins; i.e. 
the colouring principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta- 1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occurring in 
turmeric may be present. 
Curcumin is also used as the aluminium lake; the aluminium 
content is less than 30 %. 
Only the following solvents may be used in the extraction: ethy ­
lacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane, propan-2-ol.
 
Colour Index No  75300  
Einecs  207-280-5  
Chemical name  I 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione 
II 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta- 
1,6-diene-3,5-dione 
III 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione  
Chemical formula  I C  21 H 20 O 6 
II C  20 H 18 O 5 
III C  19 H 16 O 4 
Molecular weight  I. 368,39  II. 338,39  III. 308,39  
Assay  Content not less than 90 % total colouring matters  
E 1% 
1cm 1 607 at ca. 426 nm in ethanol  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 9
 
Description  Orange-yellow crystalline powder  
Identification  
Spectrometry  Maximum in ethanol at ca. 426 nm  
Melting range  179 °C-182 °C  
Purity  
Solvent residues  Ethylacetate  
Not more than 50 mg/kg, singly or in 
combination  Acetone  
n-butanol  
Methanol  
Ethanol  
Hexane  
Propan-2-ol 9 
> > > > > > > > > > > > > > > > > > = 
> > > > > > > > > > > > > > > > > > ;
 
Dichloromethane: not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 10 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 101 (i) RIBOFLAVIN 
Synonyms  Lactoflavin;  
Definition  
Colour Index No  
Einecs  201-507-1  
Chemical name  7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypen ­
tyl)benzo(g)pteridine-2,4(3H,10H)-dione; 7,8-dimethyl-10-(1 ′-D- 
ribityl)isoalloxazine  
Chemical formula  C  17 H 20 N 4 O 6 
Molecular weight  376,37  
Assay  Content not less than 98 % on the anhydrous basis  
E 1% 
1cm 328 at ca. 444 nm in aqueous solution  
Description  Yellow to orange-yellow crystalline powder, with slight odour  
Identification  
Spectrometry  The ratio A  375 /A 267 is between 0,31 and 
0,33 
in aqueous solution  
The ratio A  444 /A 267 is between 0,36 and 
0,39 9 
> > > > = 
> > > > ; 
Maximum in water at ca. 375 nm  
Specific rotation  [ α] D 20 between – 115° and – 140° in a 0,05 N sodium hydroxide 
solution  
Purity  
Loss on drying  Not more than 1,5 % (105 °C, 4 hours)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 10
 
Sulphated ash  Not more than 0,1 %  
Primary aromatic amines  Not more than 100 mg/kg (calculated as aniline)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 101 (ii) RIBOFLAVIN-5 ′-PHOSPHATE 
Synonyms  Riboflavin-5 ′-phosphate sodium  
Definition  These specifications apply to riboflavin 5 ′-phosphate together with 
minor amounts of free riboflavin and riboflavin diphosphate.  
Colour Index No  
Einecs  204-988-6  
Chemical name  Monosodium(2R,3R,4S)-5-(3 ′)10′-dihydro-7 ′,8′-dimethyl-2 ′,4′- 
dioxo-10′-benzo[γ]pteridinyl)-2,3,4-trihydroxypentyl phosphate; 
monosodium salt of 5 ′-monophosphate ester of riboflavin  
Chemical formula  For the dihydrate form: C  17 H 20 N 4 NaO  9 P · 2H  2 O 
For the anhydrous form: C  17 H 20 N 4 NaO  9 P 
Molecular weight  514,36  
Assay  Content not less than 95 % total colouring matters calculated as 
C 17 H 20 N 4 NaO  9 P.2H  2 O 
E 1% 
1cm 250 at ca. 375 nm in aqueous solution  
Description  Yellow to orange crystalline hygroscopic powder, with slight odour  
Identification  
Spectrometry  The ratio A  375 /A 267 is between 0,30 and 
0,34 
in aqueous solution  
The ratio A  444 /A 267 is between 0,35 and 
0,40 9 
>> > > > = 
>> > > > ;
 
Maximum in water at ca. 375 nm  
Specific rotation  [ α] D 20 between + 38° and + 42° in a 5 molar HCl solution  
Purity  
Loss on drying  Not more than 8 % (100 °C, 5 hours in vacuum over P  2 O 5 ) for the 
dihydrate form  
Sulphated ash  Not more than 25 %  
Inorganic phosphate  Not more than 1,0 % (calculated as PO  4 on the anhydrous basis)  
Subsidiary colouring matters  Riboflavin (free): Not more than 6 % 
Riboflavine diphosphate: Not more than 6 %  
Primary aromatic amines  Not more than 70 mg/kg (calculated as aniline)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 11
 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 102 TARTRAZINE 
Synonyms  CI Food Yellow 4  
Definition  Tartrazine is prepared from 4-amino-benzenesulphonic acid, which is 
diazotized using hydrochloric acid and sodium nitrite. The diazo 
compound is then coupled with 4,5-dihydro-5-oxo-1-(4sulphop ­
henyl)-1H-pyrazole-3-carboxylic acid or with the methyl ester, the 
ethyl ester, or a salt of this carboxylic acid. The resulting dye is 
purified and isolated as the sodium salt. Tartrazine consists essen ­
tially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatop ­
henylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters 
together with sodium chloride and/or sodium sulphate as the 
principal uncoloured components. 
Tartrazine is described as the sodium salt. The calcium and the 
potassium salt are also permitted.  
Colour Index No  19140  
Einecs  217-699-5  
Chemical name  Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatopheny ­
lazo)-H-pyrazole-3-carboxylate  
Chemical formula  C  16 H 9 N 4 Na 3 O 9 S 2 
Molecular weight  534,37  
Assay  Content not less than 85 % total colouring matters calculated as the 
sodium salt  
E 1% 
1cm 530 at ca. 426 nm in aqueous solution  
Description  Light orange powder or granules  
Appearance of the aqueous solution  Yellow  
Identification  
Spectrometry  Maximum in water at ca. 426 nm  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 1,0 %  
Organic compounds other than colouring 
matters:  
4-hydrazinobenzene sulfonic acid  
Total not more than 0,5 %  4-aminobenzene-1-sulfonic acid  
5-oxo-1-(4-sulfophenyl)-2-pyra ­
zoline-3-carboxylic acid  
4,4′-diazoaminodi(benzene sulfonic 
acid)  
Tetrahydroxysuccinic acid  9 
>> > > > > > > > > > > > > > > > = 
>> > > > > > > > > > > > > > > > ;
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 12
 
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  Not more than 0,2 % under neutral conditions  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 104 QUINOLINE YELLOW 
Synonyms  CI Food Yellow 13  
Definition  Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan- 
1,3-dione or a mixture containing about two thirds 2-(2-quino ­
lyl)indane-1,3-dione and one third 2-(2-(6-methylquinolyl))indane- 1,3-dione. Quinoline Yellow consists essentially of sodium salts of 
a mixture of disulfonates (principally), monosulfonates and trisul ­
fonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. 
Quinoline Yellow is described as the sodium salt. The calcium and 
the potassium salt are also permitted.
 
Colour Index No  47005  
Einecs  305-897-5  
Chemical name  The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3- 
dione (principal component)  
Chemical formula  C  18 H 9 N Na  2 O 8 S 2 (principal component)  
Molecular weight  477,38 (principal component)  
Assay  Content not less than 70 % total colouring matters calculated as the 
sodium salt 
Quinoline Yellow shall have the following composition: 
Of the total colouring matters present: 
— not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3- 
dione-disulfonates 
— not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3- 
dione-monosulfonates 
— not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3- 
dione-trisulfonate  
E 1% 
1cm 865 (principal component) at ca. 411 nm in aqueous acetic acid 
solution  
Description  Yellow powder or granules  
Appearance of the aqueous solution  Yellow  
Identification  
Spectrometry  Maximum in aqueous acetic acid solution of pH 5 at ca. 411 nm  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 13
 
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 4,0 %  
Organic compounds other than colouring 
matters:  
2-methylquinoline  
Total not more than 0,5 %  2-methylquinoline-sulfonic acid  
Phthalic acid  
2,6-dimethyl quinoline  
2,6-dimethyl quinoline sulfonic acid  9 
>> > > > > > > > > > > > > = 
>> > > > > > > > > > > > > ;
 
2-(2-quinolyl)indan-1,3-dione  Not more than 4 mg/kg  
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  Not more than 0,2 % under neutral conditions  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 110 SUNSET YELLOW FCF 
Synonyms  CI Food Yellow 3; Orange Yellow S  
Definition  Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4- 
sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary 
colouring matters together with sodium chloride and/or sodium 
sulphate as the principal uncoloured components. Sunset Yellow FCF is manufactured by diazotizing 4-aminobenzenesulphonic acid using hydrochloric acid and sodium nitrite or sulphuric acid and 
sodium nitrite. The diazo compound is coupled with 6-hydroxy-2- 
naphthalene-sulphonic acid. The dye is isolated as the sodium salt and dried. 
Sunset Yellow FCF is described as the sodium salt. The calcium and 
the potassium salt are also permitted.
 
Colour Index No  15985  
Einecs  220-491-7  
Chemical name  Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6- 
sulfonate  
Chemical formula  C  16 H 10 N 2 Na 2 O 7 S 2 
Molecular weight  452,37  
Assay  Content not less than 85 % total colouring matters calculated as the 
sodium salt  
E 1% 
1cm 555 at ca. 485 nm in aqueous solution at pH 7  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 14
 
Description  Orange-red powder or granules  
Appearance of the aqueous solution  Orange  
Identification  
Spectrometry  Maximum in water at ca. 485 nm at pH 7  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 5,0 %  
1-(Phenylazo)-2-naphthalenol (Sudan I)  Not more than 0,5 mg/kg  
Organic compounds other than colouring 
matters:  
4-aminobenzene-1-sulfonic acid  
Total not more than 0,5 %  3-hydroxynaphthalene-2,7-disulfonic 
acid 
6-hydroxynaphthalene-2-sulfonic 
acid 
7-hydroxynaphthalene-1,3-disulfonic 
acid 
4,4′-diazoaminodi(benzene sulfonic 
acid)  
6,6′-oxydi(naphthalene-2-sulfonic 
acid) 9 
> > > > > > > > > > > > > > > > > > > > > > > > > > = 
> > > > > > > > > > > > > > > > > > > > > > > > > > ;
 
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  Not more than 0,2 % under neutral conditions  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 120 COCHINEAL, CARMINIC ACID, CARMINES 
Synonyms  CI Natural Red 4  
Definition  Carmines and carminic acid are obtained from aqueous, aqueous 
alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insect  Dactylopius coccus  Costa. 
The colouring principle is carminic acid. 
Aluminium lakes of carminic acid (carmines) can be formed in 
which aluminium and carminic acid are thought to be present in 
the molar ratio 1:2. 
In commercial products the colouring principle is present in 
association with ammonium, calcium, potassium or sodium cations, 
singly or in combination, and these cations may also be present in excess. 
Commercial products may also contain proteinaceous material 
derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations.
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 15
 
Colour Index No  75470  
Einecs  Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724- 
4 
Chemical name  7- β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoan ­
thracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid
 
Chemical formula  C  22 H 20 O 13 (carminic acid)  
Molecular weight  492,39 (carminic acid)  
Assay  Content not less than 2,0 % carminic acid in the extracts containing 
carminic acid; not less than 50 % carminic acid in the chelates.  
Description  Red to dark red, friable, solid or powder. Cochineal extract is 
generally a dark red liquid but can also be dried as a powder.  
Identification  
Spectrometry  Maximum in aqueous ammonia solution at ca. 518 nm 
Maximum in dilute hydrochloric solution at ca. 494 nm for carminic 
acid 
E 1% 
1cm 139 at peak around 494 nm in dilute hydrochloric acid for 
carminic acid  
Purity  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 122 AZORUBINE, CARMOISINE 
Synonyms  CI Food Red 3  
Definition  Azorubine consists essentially of disodium 4-hydroxy-3-(4-sulfonato- 
1-naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. 
Azorubine is described as the sodium salt. The calcium and the 
potassium salt are also permitted.
 
Colour Index No  14720  
Einecs  222-657-4  
Chemical name  Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1- 
sulfonate  
Chemical formula  C  20 H 12 N 2 Na 2 O 7 S 2 
Molecular weight  502,44  
Assay  Content not less than 85 % total colouring matters, calculated as the 
sodium salt  
E 1% 
1cm 510 at ca. 516 nm in aqueous solution  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 16
 
Description  Red to maroon powder or granules  
Appearance of the aqueous solution  Red  
Identification  
Spectrometry  Maximum in water at ca. 516 nm  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 1 %  
Organic compounds other than colouring 
matters:  
4-aminonaphthalene-1-sulfonic acid  
Total not more than 0,5 %  
4-hydroxynaphthalene-1-sulfonic acid  9 
> = 
> ; 
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  Not more than 0,2 % under neutral conditions  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 123 AMARANTH 
Synonyms  CI Food Red 9  
Definition  Amaranth consists essentially of trisodium 2-hydroxy-1-(4-sulfonato- 
1-naphthylazo) naphthalene-3,6-disulfonate and subsidiary colouring 
matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Amaranth is manufactured by coupling 4-amino-1-naphthalenesulphonic acid with 3-hydroxy-2,7- 
naphthalenedisulphonic acid. 
Amaranth is described as the sodium salt. The calcium and the 
potassium salt are also permitted.
 
Colour Index No  16185  
Einecs  213-022-2  
Chemical name  Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6- 
disulfonate  
Chemical formula  C  20 H 11 N 2 Na 3 O 10 S 3 
Molecular weight  604,48  
Assay  Content not less than 85 % total colouring matters, calculated as the 
sodium salt  
E 1% 
1cm 440 at ca. 520 nm in aqueous solution  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 17
 
Description  Reddish-brown powder or granules  
Appearance of the aqueous solution  Red  
Identification  
Spectrometry  Maximum in water at ca. 520 nm  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 3,0 %  
Organic compounds other than colouring 
matters:  
4-aminonaphthalene-1-sulfonic acid  
Total not more than 0,5 %  3-hydroxynaphthalene-2,7-disulfonic 
acid 
6-hydroxynaphthalene-2-sulfonic acid  
7-hydroxynaphthalene-1,3-disulfonic 
acid 
7-hydroxynaphthalene-1,3-6- 
trisulfonic acid  9 
>> > > > > > > > > > > > > > > > > > = 
>> > > > > > > > > > > > > > > > > > ;
 
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  Not more than 0,2 % under neutral conditions  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 124 PONCEAU 4R, COCHINEAL RED A 
Synonyms  CI Food Red 7; New Coccine  
Definition  Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4- 
sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary 
colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Ponceau 4R is manufactured by coupling diazotized naphthionic acid to G acid 
(2-naphthol-6,8- disulphonic acid) and converting the coupling 
product to the trisodium salt. 
Ponceau 4R is described as the sodium salt. The calcium and the 
potassium salt are also permitted.
 
Colour Index No  16255  
Einecs  220-036-2  
Chemical name  Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8- 
disulfonate  
Chemical formula  C  20 H 11 N 2 Na 3 O 10 S 3 
Molecular weight  604,48  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 18
 
Assay  Content not less than 80 % total colouring matters, calculated as the 
sodium salt.  
E 1% 
1cm 430 at ca. 505 nm in aqueous solution  
Description  Reddish powder or granules  
Appearance of the aqueous solution  Red  
Identification  
Spectrometry  Maximum in water at ca. 505 nm  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 1,0 %  
Organic compounds other than colouring 
matters:  
4-aminonaphthalene-1-sulfonic acid  
Total not more than 0,5 %  7-hydroxynaphthalene-1,3-disulfonic 
acid 
3-hydroxynaphthalene-2,7-disulfonic 
acid 
6-hydroxynaphthalene-2-sulfonic acid  
7-hydroxynaphthalene-1,3-6- 
trisulfonic acid  9 
> > > > > > > > > > > > > > > > > > = 
> > > > > > > > > > > > > > > > > > ;
 
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  Not more than 0,2 % under neutral conditions  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 127 ERYTHROSINE 
Synonyms  CI Food Red 14  
Definition  Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3- 
oxido-6-oxoxanthen-9-yl) benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or 
sodium sulphate as the principal uncoloured components. 
Erythrosine is manufactured by iodination of fluorescein, the condensation product of resorcinol and phthalic anhydride 
Erythrosine is described as the sodium salt. The calcium and the 
potassium salt are also permitted.
 
Colour Index No  45430  
Einecs  240-474-8  
Chemical name  Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate 
monohydrate  
Chemical formula  C  20 H 6 I 4 Na 2 O 5 H 2 O ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 19
 
Molecular weight  897,88  
Assay  Content not less than 87 % total colouring matters, calculated as the 
anhydrous sodium salt  
E 1% 
1cm 1 100 at ca. 526 nm in aqueous solution at pH 7  
Description  Red powder or granules.  
Appearance of the aqueous solution  Red  
Identification  
Spectrometry  Maximum in water at ca. 526 nm at pH 7  
Purity  
Inorganic iodides  Not more than 0,1 % (calculated as sodium iodide)  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters (except 
fluorescein)  Not more than 4,0 %  
Fluorescein  Not more than 20 mg/kg  
Organic compounds other than colouring 
matters:  
Tri-iodoresorcinol  Not more than 0,2 %  
2-(2,4-dihydroxy-3,5-diiodobenzoyl) 
benzoic acid  Not more than 0,2 %  
Ether extractable matter  From a solution of pH from 7 through 8, not more than 0,2 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium Lakes of this colour may be used.  
E 129 ALLURA RED AC 
Synonyms  CI Food Red 17  
Definition  Allura Red AC consists essentially of disodium 2-hydroxy-1-(2- 
methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate 
and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Allura Red AC is manufactured by coupling diazotized 5-amino-4- 
methoxy-2-toluenesulphonic acid with 6-hydroxy-2-naphthalene 
sulphonic acid 
Allura Red AC is described as the sodium salt. The calcium and the 
potassium salt are also permitted.
 
Colour Index No  16035  
Einecs  247-368-0  
Chemical name  Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) 
naphthalene-6-sulfonate  
Chemical formula  C  18 H 14 N 2 Na 2 O 8 S 2 
Molecular weight  496,42  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 20
 
Assay  Content not less than 85 % total colouring matters, calculated as the 
sodium salt  
E 1% 
1cm 540 at ca. 504 nm in aqueous solution at pH 7  
Description  Dark red powder or granules  
Appearance of the aqueous solution  Red  
Identification  
Spectrometry  Maximum in water at ca. 504 nm  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 3,0 %  
Organic compounds other than colouring 
matters:  
6-hydroxy-2-naphthalene sulfonic 
acid, sodium salt  Not more than 0,3 %  
4-amino-5-methoxy-2-methyl ­
benezene sulfonic acid  Not more than 0,2 %  
6,6-oxybis (2-naphthalene sulfonic 
acid) disodium salt  Not more than 1,0 %  
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  From a solution of pH 7, not more than 0,2 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 131 PATENT BLUE V 
Synonyms  CI Food Blue 5  
Definition  Patent Blue V consists essentially of the calcium or sodium 
compound of [4-( α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfop ­
henyl-methylidene)2,5-cyclohexadien-1-ylidene] diethylammonium 
hydroxide inner salt and subsidiary colouring matters together with 
sodium chloride and/or sodium sulphate and/or calcium sulphate as the principal uncoloured components. 
The potassium salt is also permitted.
 
Colour Index No  42051  
Einecs  222-573-8  
Chemical name  The calcium or sodium compound of [4-( α-(4-diethylaminophenyl)- 
5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1- ylidene] diethyl-ammonium hydroxide inner salt
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 21
 
Chemical formula  Calcium compound: C  27 H 31 N 2 O 7 S 2 Ca 1/2 
Sodium compound: C  27 H 31 N 2 O 7 S 2 Na 
Molecular weight  Calcium compound: 579,72 
Sodium compound: 582,67  
Assay  Content not less than 85 % total colouring matters, calculated as the 
sodium salt  
E 1% 
1cm 2 000 at ca. 638 nm in aqueous solution at pH 5  
Description  Dark blue powder or granules  
Appearance of the aqueous solution  Blue  
Identification  
Spectrometry  Maximum in water at 638 nm at pH 5  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 2,0 %  
Organic compounds other than colouring 
matters:  
3-hydroxy benzaldehyde  
Total not more than 0,5 %  3-hydroxy benzoic acid  
3-hydroxy-4-sulfobenzoic acid  
N,N-diethylamino benzene sulfonic 
acid 9 
> > > > > > > > > > = 
> > > > > > > > > > ;
 
Leuco base  Not more than 4,0 %  
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  From a solution of pH 5 not more than 0,2 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 132 INDIGOTINE, INDIGO CARMINE 
Synonyms  CI Food Blue 1  
Definition  Indigotine consists essentially of a mixture of disodium 3,3 ′dioxo- 
2,2′-bi-indolylidene-5,5 ′-disulfonate, and disodium 3,3 ′-dioxo-2,2 ′-bi- 
indolylidene-5,7 ′-disulfonate and subsidiary colouring matters 
together with sodium chloride and/or sodium sulphate as the principal uncoloured components. 
Indigotine is described as the sodium salt. The calcium and the 
potassium salt are also permitted. 
Indigo carmine is obtained by sulphonation of indigo. This is accom ­
plished by heating indigo (or indigo paste) in the presence of 
sulphuric acid. The dye is isolated and subjected to purification procedures.
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 22
 
Colour Index No  73015  
Einecs  212-728-8  
Chemical name  Disodium 3,3 ′-dioxo-2,2 ′-bi-indolylidene-5,5 ′-disulfonate  
Chemical formula  C  16 H 8 N 2 Na 2 O 8 S 2 
Molecular weight  466,36  
Assay  Content not less than 85 % total colouring matters, calculated as the 
sodium salt; 
disodium 3,3 ′-dioxo-2,2 ′-bi-indolylidene-5,7 ′-disulfonate: not more 
than 18 %  
E 1% 
1cm 480 at ca. 610 nm in aqueous solution  
Description  Dark-blue powder or granules  
Appearance of the aqueous solution  Blue  
Identification  
Spectrometry  Maximum in water at ca. 610 nm  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Excluding disodium 3,3 ′-dioxo-2,2 ′-bi-indolylidene-5,7 ′-disulfonate: 
not more than 1,0 %  
Organic compounds other than colouring 
matters:  
Isatin-5-sulfonic acid  
Total not more than 0,5 % 5-sulfoanthranilic acid  
Anthranilic acid  9 
> > > > = 
> > > > ; 
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  Not more than 0,2 % under neutral conditions  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 133 BRILLIANT BLUE FCF 
Synonyms  CI Food Blue 2  
Definition  Brilliant Blue FCF consists essentially of disodium α-(4-(N-ethyl-3- 
sulfonatobenzylamino) phenyl)- α-(4-N-ethyl-3-sulfonatobenzy ­
lamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium 
chloride and/or sodium sulphate as the principal uncoloured 
components. 
Brilliant Blue FCF is described as the sodium salt. The calcium and 
the potassium salt are also permitted.
 
Colour Index No  42090  
Einecs  223-339-8  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 23
 
Chemical name  Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)- α-(4-N- 
ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene- 2-sulfonate
 
Chemical formula  C  37 H 34 N 2 Na 2 O 9 S 3 
Molecular weight  792,84  
Assay  Content not less than 85 % total colouring matters, calculated as the 
sodium salt  
E 1% 
1cm 1 630 at ca. 630 nm in aqueous solution  
Description  Reddish-blue powder or granules  
Appearance of the aqueous solution  Blue  
Identification  
Spectrometry  Maximum in water at ca. 630 nm  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 6,0 %  
Organic compounds other than colouring 
matters:  
Sum of 2-, 3- and 4-formyl benzene 
sulfonic acids  Not more than 1,5 %  
3-((ethyl)(4-sulfophenyl) amino) 
methyl benzene sulfonic acid  Not more than 0,3 %  
Leuco base  Not more than 5,0 %  
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  Not more than 0,2 % at pH 7  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 140 (i) CHLOROPHYLLS 
Synonyms  CI Natural Green 3; Magnesium Chlorophyll; Magnesium Phaeo ­
phytin  
Definition  Chlorophylls are obtained by solvent extraction of strains of edible 
plant material, grass, lucerne and nettle. During the subsequent 
removal of solvent, the naturally present coordinated magnesium may be wholly or partly removed from the chlorophylls to give the corresponding phaeophytins. The principal colouring matters are 
the phaeophytins and magnesium chlorophylls. The extracted 
product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following 
solvents may be used for the extraction: acetone, methyl ethyl 
ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 24
 
Colour Index No  75810  
Einecs  Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 
208-272-4  
Chemical name  The major colouring principles are: 
Phytyl (13  2 R,17S,18S)-3-(8-ethyl-13  2 -methoxycarbonyl-2,7,12,18- 
tetramethyl-13 ′-oxo-3-vinyl-13  1 -13 2 -17,18-tetrahydrocyclopenta 
[at]-porphyrin-17-yl)propionate, (Phaeophytin a), or as the magnesium complex (Chlorophyll a) 
Phytyl (13
 2 R,17S,18S)-3-(8-ethyl-7-formyl-13  2 -methoxycarbonyl- 
2,12,18-trimethyl-13 ′-oxo-3-vinyl-13  1 -13 2 -17,18-tetrahydrocyclo ­
penta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the 
magnesium complex (Chlorophyll b)  
Chemical formula  Chlorophyll a (magnesium complex): C  55 H 72 MgN  4 O 5 
Chlorophyll a: C  55 H 74 N 4 O 5 
Chlorophyll b (magnesium complex): C  55 H 70 MgN  4 O 6 
Chlorophyll b: C  55 H 72 N 4 O 6 
Molecular weight  Chlorophyll a (magnesium complex): 893,51 
Chlorophyll a: 871,22 
Chlorophyll b (magnesium complex): 907,49 
Chlorophyll b: 885,20  
Assay  Content of total combined Chlorophylls and their magnesium 
complexes is not less than 10 %  
E 1% 
1cm 700 at ca. 409 nm in chloroform  
Description  Waxy solid ranging in colour from olive green to dark green 
depending on the content of coordinated magnesium  
Identification  
Spectrometry  Maximum in chloroform at ca. 409 nm  
Purity  
Solvent residues  Acetone  
Not more than 50 mg/kg, 
singly or in combination  Methyl Ethyl ketone  
Methanol  
Ethanol  
Propan-2-ol  
Hexane 9 
>> > > > > > > > > > > > > > > > > > > = 
>> > > > > > > > > > > > > > > > > > > ;
 
Dichloromethane:  Not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 25
 
E 140 (ii) CHLOROPHYLLINS 
Synonyms  CI Natural Green 5; Sodium Chlorophyllin; Potassium Chloro ­
phyllin  
Definition  The alkali salts of chlorophyllins are obtained by the saponification 
of a solvent extract of strains of edible plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid 
groups are neutralised to form the salts of potassium and/or sodium. 
Only the following solvents may be used for the extraction: 
acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, 
methanol, ethanol, propan-2-ol and hexane.
 
Colour Index No  75815  
Einecs  287-483-3  
Chemical name  The major colouring principles in their acid forms are: 
— 3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinyl ­
phorbin-7-yl)propionate (chlorophyllin a) 
and 
— 3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2- 
vinylphorbin-7-yl)propionate (chlorophyllin b) 
Depending on the degree of hydrolysis the cyclopentenyl ring may 
be cleaved with the resultant production of a third carboxyl function. 
Magnesium complexes may also be present.
 
Chemical formula  Chlorophyllin a (acid form): C  34 H 34 N 4 O 5 
Chlorophyllin b (acid form): C  34 H 32 N 4 O 6 
Molecular weight  Chlorophyllin a: 578,68 
Chlorophyllin b: 592,66 Each may be increased by 18 daltons if the cyclopentenyl ring is 
cleaved.
 
Assay  Content of total chlorophyllins is not less than 95 % of the sample 
dried at ca. 100 °C for 1 hour.  
E 1% 
1cm 700 at ca. 405 nm in aqueous solution at pH 9  
E 1% 
1cm 140 at ca. 653 nm in aqueous solution at pH 9  
Description  Dark green to blue/black powder  
Identification  
Spectrometry  Maximum in aqueous phosphate buffer at pH 9 at ca. 405 nm and 
at ca. 653 nm  
Purity  
Solvent residues  Acetone  
Not more than 50 mg/kg, singly or in 
combination  Methyl ethyl ketone  
Methanol  
Ethanol  
Propan-2-ol  
Hexane 9 
> > > > > > > > > > > > > = 
> > > > > > > > > > > > > ;
 
Dichloromethane:  not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 10 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 26
 
E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS 
Synonyms  CI Natural Green 3; Copper Chlorophyll; Copper Phaeophytin  
Definition  Copper chlorophylls are obtained by addition of a salt of copper to 
the substance obtained by solvent extraction of strains of edible 
plant material, grass, lucerne, and nettle. The product, from 
which the solvent has been removed, contains other pigments such as carotenoids as well as fats and waxes derived from the source material. The principal colouring matters are the copper 
phaeophytins. Only the following solvents may be used for the 
extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
 
Colour Index No  75810  
Einecs  Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5  
Chemical name  [Phytyl (13  2 R,17S,18S)-3-(8-ethyl-13  2 -methoxycarbonyl-2,7,12,18- 
tetramethyl-13 ′-oxo-3-vinyl-13  1 -13 2 -17,18-tetrahydrocyclopenta[at]- 
porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a) 
[Phytyl (13  2 R,17S,18S)-3-(8-ethyl-7-formyl-13  2 -methoxycarbonyl- 
2,12,18-trimethyl-13 ′-oxo-3-vinyl-13  1 -13 2 -17,18-tetrahydrocyclo ­
penta[at]-porphyrin-17-yl)propionate] copper (II) (Copper chlorophyll b)
 
Chemical formula  Copper chlorophyll a: C  55 H 72 Cu N  4 O 5 
Copper chlorophyll b: C  55 H 70 Cu N  4 O 6 
Molecular weight  Copper chlorophyll a: 932,75 
Copper chlorophyll b: 946,73  
Assay  Content of total copper chlorophylls is not less than 10 %.  
E 1% 
1cm 540 at ca. 422 nm in chloroform  
E 1% 
1cm 300 at ca. 652 nm in chloroform  
Description  Waxy solid ranging in colour from blue green to dark green 
depending on the source material  
Identification  
Spectrometry  Maximum in chloroform at ca. 422 nm and at ca. 652 nm  
Purity  
Solvent residues  Acetone  
Not more than 50 mg/kg, 
singly or in combination  Methyl ethyl ketone  
Methanol  
Ethanol  
Propan-2-ol  
Hexane 9 
>> > > > > > > > > > > > > > > > > = 
>> > > > > > > > > > > > > > > > > ;
 
Dichloromethane:  not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 27
 
Copper ions  Not more than 200 mg/kg  
Total copper  Not more than 8,0 % of the total copper phaeophytins  
Aluminium lakes of this colour may be used.  
E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS 
Synonyms  Sodium Copper Chlorophyllin; Potassium Copper Chlorophyllin; CI 
Natural Green 5  
Definition  The alkali salts of copper chlorophyllins are obtained by the 
addition of copper to the product obtained by the saponification of a solvent extraction of strains of edible plant material, grass, 
lucerne, and nettle; the saponification removes the methyl and 
phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the 
acid groups are neutralised to form the salts of potassium and/or 
sodium. 
Only the following solvents may be used for the extraction: 
acetone, methyl ethyl ketone, dichloromethane, carbon dioxide 
methanol, ethanol, propan-2-ol and hexane.
 
Colour Index No  75815  
Einecs  
Chemical name  The major colouring principles in their acid forms are 3-(10- 
Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7- yl)propionate, copper complex (Copper chlorophyllin a) and 3-(10- 
Carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin- 
7-yl) propionate, copper complex (Copper chlorophyllin b)
 
Chemical formula  Copper chlorophyllin a (acid form): C  34 H 32 Cu N  4 O 5 
Copper chlorophyllin b (acid form): C  34 H 30 Cu N  4 O 6 
Molecular weight  Copper chlorophyllin a: 640,20 
Copper chlorophyllin b: 654,18 
Each may be increased by 18 daltons if the cyclopentenyl ring is 
cleaved.  
Assay  Content of total copper chlorophyllins is not less than 95 % of the 
sample dried at 100 °C for 1 h.  
E 1% 
1cm 565 at ca. 405 nm in aqueous phosphate buffer at pH 7,5  
E 1% 
1cm 145 at ca. 630 nm in aqueous phosphate buffer at pH 7,5  
Description  Dark green to blue/black powder  
Identification  
Spectrometry  Maximum in aqueous phosphate buffer at pH 7,5 at ca. 405 nm and 
at 630 nm  
Purity  
Solvent residues  Acetone  
Not more than 50 mg/kg, 
singly or in combination  Methyl ethyl ketone  
Methanol  
Ethanol  
Propan-2-ol  
Hexane 9 
> > > > > > > > > > > > > > > > > = 
> > > > > > > > > > > > > > > > > ;
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 28
 
Dichloromethane:  not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Copper ions  Not more than 200 mg/kg  
Total copper  Not more than 8,0 % of the total copper chlorophyllins  
Aluminium lakes of this colour may be used.  
E 142 GREEN S 
Synonyms  CI Food Green 4, Brilliant Green BS  
Definition  Green S consists essentially of sodium N-[4-[[4-(dimethyl ­
amino)phenyl] 2-hydroxy-3,6-disulfo-1-naphthalenyl)methylene]-2,5- 
cyclohexadien-1-ylidene]-N-methylmethanaminium and subsidiary 
colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds. 
Green S is described as the sodium salt. The calcium and the 
potassium salt are also permitted.
 
Colour Index No  44090  
Einecs  221-409-2  
Chemical name  Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1- 
naphthalenyl)-methylene]2,5-cyclohexadien-1-ylidene]-N-methyl ­
methanaminium; Sodium 5-[4-dimethylamino- α-(4-dimethylimino ­
cyclohexa-2,5-dienylidene) benzyl]-6-hydroxy-7-sulfonato-naph ­
thalene-2-sulfonate (alternative chemical name).  
Chemical formula  C  27 H 25 N 2 NaO  7 S 2 
Molecular weight  576,63  
Assay  Content not less than 80 % total colouring matters calculated as the 
sodium salt  
E 1% 
1cm 1 720 at ca. 632 nm in aqueous solution  
Description  Dark blue or dark green powder or granules  
Appearance of the aqueous solution  Blue or green  
Identification  
Spectrometry  Maximum in water at ca. 632 nm  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 1,0 %  
Organic compounds other than colouring 
matters:  
4,4′-bis(dimethylamino)-benzhydryl 
alcohol  Not more than 0,1 %  
4,4′-bis(dimethylamino)-benzop ­
henone  Not more than 0,1 %  
3-hydroxynaphthalene-2,7-disulfonic 
acid Not more than 0,2 %  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 29
 
Leuco base  Not more than 5,0 %  
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  Not more than 0,2 % under neutral conditions  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 150a PLAIN CARAMEL 
Synonyms  Caustic caramel  
Definition  Plain caramel is prepared by the controlled heat treatment of carbo ­
hydrates (commercially available food grade nutritive sweeteners 
which are the monomers glucose and fructose and/or polymers 
thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelisation, acids, alkalis and salts may be employed, with the exception of ammonium compounds and 
sulphites.
 
Colour Index No  
Einecs  232-435-9  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Dark brown to black liquids or solids  
Identification  
Purity  
Colour bound by DEAE cellulose  Not more than 50 %  
Colour bound by phosphoryl cellulose  Not more than 50 %  
Colour intensity (  1 ) 0,01-0,12  
Total nitrogen  Not more than 0,1 %  
Total sulphur  Not more than 0,2 %  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
_____________ 
( 1 ) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 6 10 nm.  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 30
 
E 150b CAUSTIC SULPHITE CARAMEL 
Synonyms  
Definition  Caustic sulphite caramel is prepared by the controlled heat treatment 
of carbohydrates (commercially available food grade nutritive swee ­
teners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of 
sulphite compounds (sulphurous acid, potassium sulphite, 
potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used.
 
Colour Index No  
Einecs  232-435-9  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Dark brown to black liquids or solids  
Identification  
Purity  
Colour bound by DEAE cellulose  More than 50 %  
Colour intensity (  1 ) 0,05-0,13  
Total nitrogen  Not more than 0,3 % (  2 ) 
Sulphur dioxide  Not more than 0,2 % (  2 ) 
Total sulphur  0,3-3,5 % (  2 ) 
Sulphur bound by DEAE cellulose  More than 40 %  
Absorbance ratio of colour bound by 
DEAE cellulose  19-34  
Absorbance ratio (A  280/560  ) Greater than 50  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 150c AMMONIA CARAMEL 
Synonyms  
Definition  Ammonia caramel is prepared by the controlled heat treatment of 
carbohydrates (commercially available food grade nutritive swee ­
teners which are the monomers glucose and fructose and/or 
polymers thereof, e.g. glucose syrups, sucrose, and/or invert 
syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and 
ammonium phosphate); no sulphite compounds are used.
 
_____________  
( 1 ) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 6 10 nm. 
( 2 ) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance unit s. ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 31
 
Colour Index No  
Einecs  232-435-9  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Dark brown to black liquids or solids  
Identification  
Purity  
Colour bound by DEAE cellulose  Not more than 50 %  
Colour bound by phosphoryl cellulose  More than 50 %  
Colour intensity (  1 ) 0,08-0,36  
Ammoniacal nitrogen  Not more than 0,3 % (  2 ) 
4-methylimidazole  Not more than 200 mg/kg (  2 ) 
2-acetyl-4-tetrahydroxy-butylimidazole  Not more than 10 mg/kg (  2 ) 
Total sulphur  Not more than 0,2 % (  2 ) 
Total nitrogen  0,7-3,3 % (  2 ) 
Absorbance ratio of colour bound by 
phosphoryl cellulose  13-35  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 150d SULPHITE AMMONIA CARAMEL 
Synonyms  
Definition  Sulphite ammonia caramel is prepared by the controlled heat 
treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof (e.g. glucose syrups, sucrose, and/or invert 
syrups, and dextrose) with or without acids or alkalis in the presence 
of both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, 
ammonium hydrogen carbonate, ammonium phosphate, ammonium 
sulphate, ammonium sulphite and ammonium hydrogen sulphite).
 
Colour Index No  
Einecs  232-435-9  
Chemical name  
Chemical formula  
_____________  
( 1 ) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 6 10 nm. 
( 2 ) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance unit s. ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 32
 
Molecular weight  
Assay  
Description  Dark brown to black liquids or solids  
Identification  
Purity  
Colour bound by DEAE cellulose  More than 50 %  
Colour intensity (  1 ) 0,10-0,60  
Ammoniacal nitrogen  Not more than 0,6 % (  2 ) 
Sulphur dioxide  Not more than 0,2 % (  2 ) 
4-methylimidazole  Not more than 250 mg/kg (  2 ) 
Total nitrogen  0,3-1,7 % (  2 ) 
Total sulphur  0,8-2,5 % (  2 ) 
Nitrogen/sulphur ratio of alcohol 
precipitate  0,7-2,7  
Absorbance ratio of alcohol precipitate (  3 ) 8-14  
Absorbance ratio (A  280/560  ) Not more than 50  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
▼M8 
E 151 BRILLIANT BLACK PN  
▼B 
Synonyms  CI Food Black 1  
▼M8 
Definition  Brilliant Black PN consists essentially of tetrasodium-4-acetamido-5- 
hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate and subsidiary colouring matters 
together with sodium chloride and/or sodium sulphate as the 
principal uncoloured components. 
Brilliant Black PN is described as the sodium salt. 
The calcium and the potassium salt are also permitted.
 
▼B 
Colour Index No  28440  
Einecs  219-746-5  
Chemical name  Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatop ­
henylazo)-1-naphthylazo] naphthalene-1,7-disulfonate  
Chemical formula  C  28 H 17 N 5 Na 4 O 14 S 4 
Molecular weight  867,69  
_____________  
( 1 ) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 6 10 nm. 
( 2 ) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance unit s. 
( 3 ) Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance a t 
560 nm (1 cm cell).  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 33
 
Assay  Content not less than 80 % total colouring matters calculated as the 
sodium salt  
E 1% 
1cm 530 at ca. 570 nm in solution  
Description  Black powder or granules  
Appearance of the aqueous solution  Black-bluish  
Identification  
Spectrometry  Maximum in water at ca. 570 nm  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 4 % (expressed on the dye content)  
Organic compounds other than colouring 
matters:  
4-acetamido-5-hydroxynaphthalene- 
1,7-disulfonic acid  
Total not more than 0,8 %  4-amino-5-hydroxynaphthalene-1,7- 
disulfonic acid  
8-aminonaphthalene-2-sulfonic acid-  
4,4′-diazoaminodi-(benzenesulfonic 
acid) 9 
>> > > > > > > > > > > > > > > > > = 
>> > > > > > > > > > > > > > > > > ;
 
Unsulfonated primary aromatic amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  Not more than 0,2 % under neutral conditions  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 153 VEGETABLE CARBON 
Synonyms  Vegetable black  
Definition  Vegetable activated carbon is produced by the carbonisation of 
vegetable material such as wood, cellulose residues, peat and 
coconut and other shells. The activated carbon thus produced is 
milled by a roller mill and the resulting highly activated powdered carbon is treated by a cyclone. The fine fractio40800n from the cyclone is purified by hydrochloric acid washing, neutralised and 
then dried. The resulting product is what is known traditionally as 
vegetable black. Products with a higher colouring power are produced from the fine fraction by a further cyclone treatment or by extra milling, followed by acid washing, neutralising and drying. 
It consists essentially of finely divided carbon. It may contain minor 
amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manufacture.
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 34
 
Colour Index No  77266  
Einecs  231-153-3  
Chemical name  Carbon  
Chemical formula  C  
Atomic weight  12,01  
Assay  Content not less than 95 % of carbon calculated on an anhydrous 
and ash-free basis  
Loss on drying  Not more than 12 % (120 °C 4 h)  
Description  Black, odourless powder  
Identification  
Solubility  Insoluble in water and organic solvents  
Burning  When heated to redness it burns slowly without a flame  
Purity  
Ash (Total)  Not more than 4,0 % (ignition temperature: 625 °C)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Polycyclic aromatic hydrocarbons  Benzo(a)pyrene less than 50 μg/kg in the extract obtained by 
extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction.
 
Alkali soluble matter  The filtrate obtained by boiling 2 g of the sample with 20 ml N 
sodium hydroxide and filtering shall be colourless  
E 155 BROWN HT 
Synonyms  CI Food Brown 3  
Definition  Brown HT consists essentially of disodium 4,4 ′-(2,4-dihydroxy-5- 
hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) 
and subsidiary colouring matters together with sodium chloride and/or sulphate as the principal uncoloured components. 
Brown HT is described as the sodium salt. The calcium and 
potassium salt are also permitted.
 
Colour Index No  20285  
Einecs  224-924-0  
Chemical name  Disodium 4,4 ′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene 
bisazo)di (naphthalene-1-sulfonate)  
Chemical formula  C  27 H 18 N 4 Na 2 O 9 S 2 
Molecular weight  652,57  
Assay  Content not less than 70 % total colouring matters calculated as the 
sodium salt.  
E 1% 
1cm 403 at ca. 460 nm in aqueous solution at pH 7  
Description  Reddish-brown powder or granules  
Appearance of the aqueous solution  Brown  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 35
 
Identification  
Spectrometry  Maximum in water of pH 7 at ca. 460 nm  
Purity  
Water insoluble matter  Not more than 0,2 %  
Subsidiary colouring matters  Not more than 10 % (TLC method)  
Organic compounds other than colouring 
matters:  
4-aminonaphthalene- 1-sulfonic acid  Not more than 0,7 %  
Unsulfonated primary aromatic 
amines  Not more than 0,01 % (calculated as aniline)  
Ether extractable matter  Not more than 0,2 % in a solution of pH 7  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 160 a (i) BETA-CAROTENE 
Synonyms  CI Food Orange 5  
Definition  These specifications apply predominantly to all trans isomer of beta- 
carotene together with minor amounts of other carotenoids. Diluted 
and stabilised preparations may have different trans-cis isomer ratios.  
Colour Index No  40800  
Einecs  230-636-6  
Chemical name  Beta-carotene; beta, beta-carotene  
Chemical formula  C  40 H 56 
Molecular weight  536,88  
Assay  Not less than 96 % total colouring matters (expressed as beta- 
carotene)  
E 1% 
1cm 2 500 at approximately by 440 nm to 457 nm in cyclohexane  
Description  Red to brownish-red crystals or crystalline powder  
Identification  
Spectrometry  Maximum in cyclohexane at 453 nm to 456 nm  
Purity  
Sulphated ash  Not more than 0,1 %  
Subsidiary colouring matters  Carotenoids other than beta-carotene: not more than 3,0 % of total 
colouring matters  
Lead  Not more than 2 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 36
 
E 160 a (ii) PLANT CAROTENES 
Synonyms  CI Food Orange 5  
Definition  Plant carotenes are obtained by solvent extraction of strains of 
edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and 
nettle. 
The main colouring principle consists of carotenoids of which beta- 
carotene accounts for the major part. Alpha, gamma-carotene and 
other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material. 
Only the following solvents may be used in the extraction: acetone, 
methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane (
 1 ), 
dichloromethane and carbon dioxide.  
Colour Index No  75130  
Einecs  230-636-6  
Chemical name  
Chemical formula  Beta-carotene: C  40 H 56 
Molecular weight  Beta-carotene: 536,88  
Assay  Content of carotenes (calculated as beta-carotene) is not less than 
5 %. For products obtained by extraction of vegetables oils: not less than 0,2 % in edible fats
 
E 1% 
1cm 2 500 at approximately 440 nm to 457 nm in cyclohexane  
Description  
Identification  
Spectrometry  Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 
486 nm  
Purity  
Solvent residues  Acetone  
Not more than 50 mg/kg, 
singly or in combination  Methyl ethyl ketone  
Methanol  
Propan-2-ol  
Hexane  
Ethanol 9 
> > > > > > > > > > > > > > > = 
> > > > > > > > > > > > > > > ;
 
Dichloromethane  Not more than 10 mg/kg  
Lead  Not more than 2 mg/kg  
E 160 a (iii) BETA-CAROTENE FROM  Blakeslea trispora  
Synonyms  CI Food Orange 5  
Definition  Obtained by a fermentation process using a mixed culture of the 
two sexual mating types (+) and (–) of strains of the fungus  
Blakeslea trispora . The beta-carotene is extracted from the 
biomass with ethyl acetate or isobutyl acetate followed by 
propan-2-ol and crystallised. The crystallised product consists 
mainly of trans beta-carotene. Because of the natural process approximately 3 % of the product consists of mixed carotenoids, which is specific for the product.
 
_____________  
( 1 ) Benzene not more than 0,05 % v/v.  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 37
 
Colour Index No  40800  
Einecs  230-636-6  
Chemical name  Beta-carotene; beta, beta-carotene  
Chemical formula  C  40 H 56 
Molecular weight  536,88  
Assay  Not less than 96 % total colouring matters (expressed as beta- 
carotene)  
E 1% 
1cm 2 500 at approximately 440 nm to 457 nm in cyclohexane  
Description  Red, brownish-red or purple-violet crystals or crystalline powder 
(colour varies according to extraction solvent used and conditions 
of crystallisation)  
Identification  
Spectrometry  Maximum in cyclohexane at 453 nm to 456 nm  
Purity  
Solvent residues  Ethyl acetate  Not more than 0,8 %, singly 
or in combination  Ethanol 9 
= 
; 
Isobutyl acetate: Not more than 1,0 %  
Propan-2-ol: Not more than 0,1 %  
Sulphated ash  Not more than 0,2 %  
Subsidiary colouring matters  Carotenoids other than beta-carotene: not more than 3,0 % of total 
colouring matters  
Lead  Not more than 2 mg/kg  
Microbiological criteria  
Moulds  Not more than 100 colonies per gram  
Yeasts  Not more than 100 colonies per gram  
Salmonella  spp.  Absent in 25 g  
Escherichia coli  Absent in 5 g  
E 160 a (iv) ALGAL CAROTENES 
Synonyms  CI Food Orange 5  
▼M8 
Definition  Mixed carotenes may also be produced from strains of the algae  
Dunaliella salina . Beta-carotene is extracted using an essential oil. 
The preparation is a 20 to 30 % suspension in edible oil. The ratio of 
trans-cis isomers is in the range of 50/50 to 71/29. 
The main colouring principle consists of carotenoids of which beta- 
carotene accounts for the major part. Alpha-carotene, lutein, zeax ­
anthin and beta-cryptoxanthin may be present. Besides the colour 
pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.
 
▼B 
Colour Index No  75130  
Einecs  
Chemical name  
Chemical formula  Beta-Carotene: C  40 H 56 
Molecular weight  Beta-Carotene: 536,88  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 38
 
Assay  Content of carotenes (calculated as beta-carotene) is not less than 
20 %  
E 1% 
1cm 2 500 at approximately by 440 nm to 457 nm in cyclohexane  
Description  
Identification  
Spectrometry  Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 
486 nm  
Purity  
Natural tocopherols in edible oil  Not more than 0,3 %  
Lead  Not more than 2 mg/kg  
E 160 b ANNATTO, BIXIN, NORBIXIN  
(i) SOLVENT-EXTRACTED BIXIN AND NORBIXIN  
Synonyms  CI Natural Orange 4  
Definition  Bixin is prepared by the extraction of the outer coating of the seeds 
of the annatto tree ( Bixa orellana  L.) with one or more of the 
following solvents: acetone, methanol, hexane or dichloromethane, 
carbon dioxide followed by the removal of the solvent. 
Norbixin is prepared by hydrolysis by aqueous alkali of the 
extracted bixin. 
Bixin and norbixin may contain other materials extracted from the 
annatto seed. 
The bixin powder contains several coloured components, the major 
single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present. 
The norbixin powder contains the hydrolysis product of bixin, in 
the form of the sodium or potassium salts as the major colouring principle. Both cis- and trans-forms may be present.
 
Colour Index No  75120  
Einecs  Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230- 
248-7  
Chemical name  
Bixin:  6′-Methylhydrogen-9 ′-cis- 
6,6′-diapocarotene-6,6 ′-dioate  
6′-Methylhydrogen-9 ′-trans - 
6,6′-diapocarotene-6,6 ′-dioate 8 
> > > > > < 
> > > > > :
 
Norbixin:  9′cis-6,6′-Diapocarotene-6,6 ′- 
dioic acid  
9′-trans -6,6′-Diapocarotene- 
6,6′-dioic acid 8 
> > > > > < 
> > > > > :
 
Chemical formula  Bixin:  C  25 H 30 O 4 
Norbixin:  C  24 H 28 O 4 
Molecular weight  Bixin:  394,51  
Norbixin:  380,48  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 39
 
Assay  Content of bixin powders not less than 75 % total carotenoids 
calculated as bixin.  
Content of norbixin powders not less than 25 % total carotenoids 
calculated as norbixin  
Bixin:  E  1% 
1cm 2 870 at ca. 502 nm in 
chloroform  
Norbixin:  E  1% 
1cm 2 870 at ca. 482 nm in 
KOH solution  
Description  Reddish-brown powder, suspension or solution  
Identification  
Spectrometry  Bixin:  maximum in chloroform at 
ca. 502 nm  
Norbixin:  maximum in dilute KOH 
solution at ca. 482 nm  
Purity  
Solvent residues  Acetone  
not more than 50 mg/kg, 
singly or in combination  Methanol  
Hexane 9 
>> > > > > = 
>> > > > > ;
 
Dichloromethane:  not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
(ii) ALKALI EXTRACTED ANNATTO  
Synonyms  CI Natural Orange 4  
Definition  Water soluble annatto is prepared by extraction with aqueous alkali 
(sodium or potassium hydroxide) of the outer coating of the seeds 
of the annatto tree ( Bixa orellana  L.) 
Water soluble annatto contains norbixin, the hydrolysis product of 
bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present.
 
Colour Index No  75120  
Einecs  Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230- 
248-7  
Chemical name  
Bixin:  6′-Methylhydrogen-9 ′-trans - 
6,6′-diapocarotene-6,6 ′-dioate  
6′-Methylhydrogen-9 ′-trans - 
6,6′-diapocarotene-6,6 ′-dioate 8 
> > > < 
> > > : 
Norbixin:  9′cis-6,6′-Diapocarotene-6,6 ′- 
dioic acid  
6′-Methylhydrogen-9 ′-trans - 
6,6′-diapocarotene-6,6 ′-dioate 8 
> > > < 
> > > : ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 40
 
Chemical formula  Bixin:  C  25 H 30 O 4 
Norbixin:  C  24 H 28 O 4 
Molecular weight  Bixin:  394,51  
Norbixin:  380,48  
Assay  Contains not less than 0,1 % of total carotenoids expressed as 
norbixin  
Norbixin:  E  1% 
1cm 2 870 at ca. 482 nm in 
KOH solution  
Description  Reddish-brown powder, suspension or solution  
Identification  
Spectrometry  Bixin:  maximum in chloroform at 
ca. 502 nm  
Norbixin:  maximum in dilute KOH 
solution at ca. 482 nm  
Purity  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
(iii) OIL EXTRACTED ANNATTO  
Synonyms  CI Natural Orange 4  
Definition  Annatto extracts in oil, as solution or suspension, are prepared by 
extraction of the outer coating of the seeds of the annatto tree ( Bixa 
orellana  L.) with edible vegetable oil. Annatto extract in oil 
contains several coloured components, the major single one being bixin, which may be present in both cis- and trans-forms. Thermal degradation products of bixin may also be present.
 
Colour Index No  75120  
Einecs  Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230- 
248-7  
Chemical name  
Bixin:  6′-Methylhydrogen-9 ′-cis- 
6,6′-diapocarotene-6,6 ′-dioate  
6′-Methylhydrogen-9 ′-trans - 
6,6′-diapocarotene-6,6 ′-dioate 8 
> > > > > < 
> > > > > :
 
Norbixin:  9′cis-6,6′-Diapocarotene-6,6 ′- 
dioic acid  
9′-trans -6,6′-Diapocarotene- 
6,6′-dioic acid 8 
> > > > > < 
> > > > > :
 
Chemical formula  Bixin:  C  25 H 30 O 4 
Norbixin:  C  24 H 28 O 4 
Molecular weight  Bixin:  394,51  
Norbixin:  380,48  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 41
 
Assay  Contains not less than 0,1 % of total carotenoids expressed as bixin  
Bixin:  E  1% 
1cm 2 870 at ca. 502 nm in 
chloroform  
Description  Reddish-brown powder, suspension or solution  
Identification  
Spectrometry  Bixin:  maximum in chloroform at 
ca. 502 nm  
Norbixin:  maximum in dilute KOH 
solution at ca. 482 nm  
Purity  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 160 c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN 
Synonyms  Paprika Oleoresin  
Definition  Paprika extract is obtained by solvent extraction of the strains of 
paprika, which consists of the ground fruits pods, with or without seeds, of  Capsicum annuum  L., and contains the major colouring 
principles of this spice. The major colouring principles are caps ­
anthin and capsorubin. A wide variety of other coloured 
compounds is known to be present. 
Only the following solvents may be used in the extraction: 
methanol, ethanol, acetone, hexane, dichloromethane, ethyl 
acetate, propan-2-ol and carbon dioxide.
 
Colour Index No  
Einecs  Capsanthin: 207-364-1, capsorubin: 207-425-2  
Chemical name  Capsanthin: (3R, 3 ′S, 5′R)-3,3′-dihydroxy- β,κ-carotene-6-one 
Capsorubin: (3S, 3 ′S, 5R, 5R ′)-3,3′-dihydroxy- κ,κ-carotene-6,6 ′- 
dione  
Chemical formula  Capsanthin:  C  40 H 56 O 3 
Capsorubin:  C  40 H 56 O 4 
Molecular weight  Capsanthin:  584,85  
Capsorubin:  600,85  
Assay  Paprika extract: content not less than 7,0 % carotenoids 
Capsanthin/capsorubin: not less than 30 % of total carotenoids  
E 1% 
1cm 2 100 at ca. 462 nm in acetone  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 42
 
Description  Dark-red viscous liquid  
Identification  
Spectrometry  Maximum in acetone at ca. 462 nm  
Colour reaction  A deep blue colour is produced by adding one drop of sulphuric 
acid to one drop of sample in 2-3 drops of chloroform  
Purity  
Solvent residues  Ethyl acetate  
Not more than 50 mg/kg, 
singly or in combination  Methanol  
Ethanol  
Acetone  
Hexane  
Propan-2-ol 9 
> > > > > > > > > > > > > > > > > = 
> > > > > > > > > > > > > > > > > ;
 
Dichloromethane:  not more than 10 mg/kg  
Capsaicin  Not more than 250 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 160 d LYCOPENE  
(i) SYNTHETIC LYCOPENE  
Synonyms  Lycopene from chemical synthesis  
Definition  Synthetic lycopene is a mixture of geometric isomeres of lycopenes 
and is produced by the Wittig condensation of synthetic inter ­
mediates commonly used in the production of other carotenoids 
used in food. Synthetic lycopene consists predominantly of all-  
trans -lycopene together with 5- cis-lycopene and minor quantities 
of other isomers. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water- 
dispersible or water-soluble powder.
 
Colour Index No  75125  
Einecs  207-949-1  
Chemical name  ψ,ψ-carotene, all- trans -lycopene, (all-E)-lycopene, (all-E)- 
2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14 ,16,18,20,22,24,26, 
30-dotriacontatridecaene  
Chemical formula  C  40 H 56 
Molecular weight  536,85  
Assay  Not less than 96 % total lycopenes (not less than 70 % all- trans - 
lycopene)  
E 1% 
1cm at 465-475 nm in hexane (for 100 % pure all- trans -lycopene) is 
3 450  
Description  Red crystalline powder  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 43
 
Identification  
Spectrophotometry  A solution in hexane shows an absorption maximum at approxi ­
mately 470 nm  
Test for carotenoids  The colour of the solution of the sample in acetone disappears after 
successive additions of a 5 % solution of sodium nitrite and 1N sulphuric acid
 
Solubility  Insoluble in water, freely soluble in chloroform  
Properties of 1 % solution in chloroform  Is clear and has intensive red-orange colour  
Purity  
Loss on drying  Not more than 0,5 % (40 °C, 4 h at 20 mm Hg)  
Apo-12’-lycopenal  Not more than 0,15 %  
Triphenyl phosphine oxide  Not more than 0,01 %  
Solvent residues  Methanol not more than 200 mg/kg, 
Hexane, Propan-2-ol: Not more than 10 mg/kg each. 
Dichloromethane: Not more than 10 mg/kg (in commercial prep ­
arations only)  
Lead  Not more than 1 mg/kg  
(ii) LYCOPENE FROM RED TOMATOES 
Synonyms  Natural Yellow 27  
Definition  Lycopene is obtained by solvent extraction of red tomatoes ( Lyco­
persicon esculentum  L.) with subsequent removal of the solvent. 
Only the following solvent may be used: carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol and hexane. The 
major colouring principle of tomatoes is lycopene; minor amounts 
of other carotenoid pigments may be present. Besides the colour pigments the product may contain oil, fats, waxes and flavour 
components naturally occurring in tomatoes.
 
Colour Index No  75125  
Einecs  207-949-1  
Chemical name  Ψ,Ψ-carotene, all- trans -lycopene, (all-E)-lycopene, (all-E)- 
2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,2 0,22,24,26, 30-dotriacontatridecaene
 
Chemical formula  C  40 H 56 
Molecular weight  536,85  
Assay  E  1% 
1cm at 465-475 nm in hexane (for 100 % pure all- trans -lycopene) 
is 3 450. 
Content not less than 5 % total colouring matters  
Description  Dark red viscous liquid  
Identification  
Spectrophotometry  Maximum in hexane at ca. 472 nm  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 44
 
Purity  
Solvent residues  Propan-2-ol  
Not more than 50 mg/kg, 
singly or in combination  Hexane  
Acetone  
Ethanol  
Methanol  
Ethylacetate 9 
> > > > > > > > > > > > > > > > > = 
> > > > > > > > > > > > > > > > > ;
 
Sulphated ash  Not more than 1 %  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
(iii) LYCOPENE FROM  BLAKESLEA TRISPORA  
Synonyms  Natural Yellow 27  
Definition  Lycopene from  Blakeslea trispora  is extracted from the fungal 
biomass and purified by crystallisation and filtration. It consists predominantly of all- trans -lycopene. It also contains minor quantities 
of other carotenoids. Propan-2-ol and isobutyl acetate are the only 
solvents used in the manufacture. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water-soluble powder.
 
Colour Index No  75125  
Einecs  207-949-1  
Chemical name  Ψ,Ψ-carotene, all- trans -lycopene, (all-E)-lycopene, ((all-E)- 
2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14 ,16,18,20,22,24,26, 
30-dotriacontatridecaene  
Chemical formula  C  40 H 56 
Molecular weight  536,85  
Assay  Not less than 95 % total lycopenes and not less than 90 % all- trans - 
lycopene of all colouring matters  
E 1% 
1cm at 465-475 nm in hexane (for 100 % pure all- trans -lycopene) is 
3 450  
Description  Red crystalline powder  
Identification  
Spectrophotometry  A solution in hexane shows an absorption maximum at approxi ­
mately 470 nm  
Test of carotenoids  The colour of the solution of the sample in acetone disappears after 
successive additions of a 5 % solution of sodium nitrite and 1N 
sulphuric acid  
Solubility  Insoluble in water, freely soluble in chloroform  
Properties of 1 % solution in chloroform  Is clear and has intensive red-orange colour  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 45
 
Purity  
Loss on drying  Not more than 0,5 % (40 °C, 4 h at 20 mm Hg)  
Other carotenoids  Not more than 5 %  
Solvent residues  Propan-2-ol: not more than 0,1 % 
Isobutyl acetate: not more than 1,0 % 
Dichloromethane: not more than 10 mg/kg (in commercial prep ­
arations only)  
Sulphated ash  Not more than 0,3 %  
Lead  Not more than 1 mg/kg  
E 160 e BETA-APO-8 ′-CAROTENAL (C30) 
Synonyms  CI Food Orange 6  
Definition  These specifications apply predominantly to the all- trans  isomer of 
β-apo-8′-carotenal together with minor amounts of other carotenoids. 
Diluted and stabilised forms are prepared from β-apo-8′-carotenal 
meeting these specifications and include solutions or suspensions of ß-apo-8 ′carotenal in edible fats or oils, emulsions and water 
dispersible powders. These preparations may have different cis/ 
trans isomer ratios.
 
Colour Index No  40820  
Einecs  214-171-6  
Chemical name  β-Apo-8′-carotenal;  trans -β-Apo-8′carotene-aldehyde  
Chemical formula  C  30 H 40 O 
Molecular weight  416,65  
Assay  Not less than 96 % of total colouring matters  
E 1% 
1cm 2 640 at 460-462 nm in cyclohexane  
Description  Dark violet crystals with metallic lustre or crystalline powder  
Identification  
Spectrometry  Maximum in cyclohexane at 460-462 nm  
Purity  
Sulphated ash  Not more than 0,1 %  
Subsidiary colouring matters  Carotenoids other than β-apo-8′-carotenal: 
not more than 3,0 % of total colouring matters  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 161 b LUTEIN 
Synonyms  Mixed Carotenoids; Xanthophylls  
Definition  Lutein is obtained by solvent extraction of the strains of edible 
fruits and plants, grass, lucerne (alfalfa) and  Tagetes erecta . The 
main colouring principle consists of carotenoids of which lutein  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 46
 
and its fatty acid esters account for the major part. Variable 
amounts of carotenes will also be present. Lutein may contain 
fats, oils and waxes naturally occurring in the plant material. 
Only the following solvents may be used for the extraction: 
methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl 
ketone and carbon dioxide  
Colour Index No  
Einecs  204-840-0  
Chemical name  3,3 ′-dihydroxy-d-carotene  
Chemical formula  C  40 H 56 O 2 
Molecular weight  568,88  
Assay  Content of total colouring matter not less than 4 % calculated as 
lutein  
E 1% 
1cm 2 550 at ca. 445 nm in chloroform/ethanol (10 + 90) or in 
hexane/ethanol/acetone (80 + 10 + 10)  
Description  Dark, yellowish brown liquid  
Identification  
Spectrometry  Maximum in chloroform/ethanol (1:9) at ca. 445 nm  
Purity  
Solvent residues  Acetone  
Not more than 50 mg/kg, 
singly or in combination  Methyl ethyl ketone  
Methanol  
Ethanol  
Propan-2-ol  
Hexane 9 
> > > > > > > > > > > > > > > > > > > = 
> > > > > > > > > > > > > > > > > > > ;
 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 3 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 161g CANTHAXANTHIN 
Synonyms  CI Food Orange 8  
Definition  These specifications apply to predominantly all- trans  isomers of 
canthaxanthin together with minor amounts of other carotenoids. 
Diluted and stabilised forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water 
dispersible powders. These preparations may have different cis/ 
trans isomer ratios.
 
Colour Index No  40850  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 47
 
Einecs  208-187-2  
Chemical name  β-Carotene-4,4 ′-dione; canthaxanthin; 4,4 ′-dioxo-β-carotene  
Chemical formula  C  40 H 52 O 2 
Molecular weight  564,86  
Assay  Not less than 96 % of total colouring matters (expressed as 
canthaxanthin)  
E 1% 
1cm 2 200  at ca. 485 nm in chloroform  
at 468-472 nm in cyclo ­
hexane  
at 464-467 nm in petroleum 
ether 8 
> > > > > > > > < 
> > > > > > > > :
 
Description  Deep violet crystals or crystalline powder  
Identification  
Spectrometry  Maximum in chloroform at ca. 485 nm 
Maximum in cyclohexane at 468-472 nm 
Maximum in petroleum ether at 464-467 nm  
Purity  
Sulphated ash  Not more than 0,1 %  
Subsidiary colouring matters  Carotenoids other than canthaxanthin: not more than 5,0 % of total 
colouring matters  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 162 BEETROOT RED, BETANIN 
Synonyms  Beet Red  
Definition  Beet red is obtained from the roots of strains of red beets ( Beta 
vulgaris  L. var.  rubra ) by pressing crushed beet as press juice or 
by aqueous extraction of shredded beet roots and subsequent 
enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin 
accounts for 75-95 %. Minor amounts of betaxanthin (yellow) and 
degradation products of betalaines (light brown) may be present. 
Besides the colour pigments the juice or extract consists of sugars, 
salts, and/or proteins naturally occurring in red beets. The solution 
may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins.
 
Colour Index No  
Einecs  231-628-5  
Chemical name  (S-(R ′,R′)-4-(2-(2-Carboxy-5( β-D-glucopyranosyloxy)-2,3-dihydro-6- 
hydroxy-1H-indol-1-yl)ethenyl)-2,3-dihydro-2,6-pyridine-dicar ­
boxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4-pyridyli ­
dene)ethylidene)-5- β-D-glucopyranosyloxy)-6-hydroxyindolium-2- 
carboxylate  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 48
 
Chemical formula  Betanin: C  24 H 26 N 2 O 13 
Molecular weight  550,48  
Assay  Content of red colour (expressed as betanine) is not less than 0,4 %  
E 1% 
1cm 1 120 at ca. 535 nm in aqueous solution at pH 5  
Description  Red or dark red liquid, paste, powder or solid  
Identification  
Spectrometry  Maximum in water of pH 5 at ca. 535 nm  
Purity  
Nitrate  Not more than 2 g nitrate anion/g of red colour (as calculated from 
assay).  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 163 ANTHOCYANINS 
Synonyms  
Definition  Anthocyanins are obtained by maceration or extraction with 
sulphited water, acidified water, carbon dioxide, methanol or 
ethanol from the strains of vegetables and edible fruits, with 
subsequent concentration and/or purification if necessary. The resulting product can be transformed into powder by an industrial drying process. Anthocyanins contain common components of the 
source material, namely anthocyanine, organic acids, tannins, 
sugars, minerals etc., but not necessarily in the same proportions as found in the source material. Ethanol may naturally be present as a result of the maceration process. The colouring principle is antho ­
cyanin. Products are marketed according to their colour strength as 
determined by the assay. Colour content is not expressed using quantitative units.
 
Colour Index No  
Einecs  208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (del ­
phinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin); 215- 849-4 (petunidin)
 
Chemical name  3,3 ′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin) 
3,4′,5,7-Tetrahydroxy-3 ′-methoxyflavylium chloride (peonidin) 
3,4′,5,7-Tetrahydroxy-3 ′,5′-dimethoxyflavylium chloride (malvidin) 
3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium 
chloride (delphinidin) 
3,3′4′,5,7-Pentahydroxy-5 ′-methoxyflavylium chloride (petunidin) 
3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride 
(pelargonidin)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 49
 
Chemical formula  Cyanidin: C  15 H 11 O 6 Cl 
Peonidin: C  16 H 13 O 6 Cl 
Malvidin: C  17 H 15 O 7 Cl 
Delphinidin: C  15 H 11 O 7 Cl 
Petunidin: C  16 H 13 O 7 Cl 
Pelargonidin: C  15 H 11 O 5 Cl 
Molecular weight  Cyanidin: 322,6 
Peonidin: 336,7 
Malvidin: 366,7 
Delphinidin: 340,6 
Petunidin: 352,7 
Pelargonidin: 306,7  
Assay  E  1% 
1cm 300 for the pure pigment at 515-535 nm at pH 3,0  
Description  Purplish-red liquid, powder or paste, having a slight characteristic 
odour  
Identification  
Spectrometry  Maximum in methanol with 0,01 % conc. HCl 
Cyanidin: 535 nm Peonidin: 532 nm 
Malvidin: 542 nm 
Delphinidin: 546 nm 
Petunidin: 543 nm 
Pelargonidin: 530 nm
 
Purity  
Solvent residues  Methanol  Not more than 50 mg/kg  
Ethanol  Not more than 200 mg/kg  
Sulfur dioxide  Not more than 1 000 mg/kg per percent pigment  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 170 CALCIUM CARBONATE 
Synonyms  CI Pigment White 18; Chalk  
Definition  Calcium carbonate is the product obtained from ground limestone or 
by the precipitation of calcium ions with carbonate ions.  
Colour Index No  77220  
Einecs  Calcium carbonate: 207-439-9 
Limestone: 215-279-6  
Chemical name  Calcium carbonate  
Chemical formula  CaCO  3 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 50
 
Molecular weight  100,1  
Assay  Content not less than 98 % on the anhydrous basis  
Description  White crystalline or amorphous, odourless and tasteless powder  
Identification  
Solubility  Practically insoluble in water and in alcohol. Dissolves with effer ­
vescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium.
 
Purity  
Loss on drying  Not more than 2,0 % (200 °C, 4 hours)  
Acid-insoluble substances  Not more than 0,2 %  
Magnesium and alkali salts  Not more than 1 %  
Fluoride  Not more than 50 mg/kg  
Antimony (as Sb)  
Not more than 100 mg/kg, singly or in combination  Copper (as Cu)  
Chromium (as Cr)  
Zinc (as Zn)  
Barium (as Ba)  9 
> > > > > > > > > > > > > > = 
> > > > > > > > > > > > > > ;
 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 3 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 171 TITANIUM DIOXIDE 
Synonyms  CI Pigment White 6  
Definition  Titanium dioxide consists essentially of pure anatase and/or rutile 
titanium dioxide which may be coated with small amounts of 
alumina and/or silica to improve the technological properties of 
the product. 
The anatase grades of pigmentary titanium dioxide can only be made 
by the sulphate process which creates a large amount of sulphuric 
acid as a by-product. The rutile grades of titanium dioxide are typically made by the chloride process. 
Certain rutile grades of titanium dioxide are produced using mica 
(also known as potassium aluminum silicate) as a template to form the basic platelet structure. The surface of the mica is coated with titanium dioxide using a specialised patented process. 
Rutile titanium dioxide, platelet form is manufactured by subjecting 
titanium dioxide (rutile) coated mica nacreous pigment to an extractive dissolution in acid followed by an extractive dissolution 
in alkali. All of the mica is removed during this process and the 
resulting product is a platelet form of rutile titanium dioxide.
 
Colour Index No  77891  
Einecs  236-675-5  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 51
 
Chemical name  Titanium dioxide  
Chemical formula  TiO  2 
Molecular weight  79,88  
Assay  Content not less than 99 % on an alumina and silica-free basis  
Description  White to slightly coloured powder  
Identification  
Solubility  Insoluble in water and organic solvents. Dissolves slowly in hydro ­
fluoric acid and in hot concentrated sulphuric acid.  
Purity  
Loss on drying  Not more than 0,5 % (105 °C, 3 hours)  
Loss on ignition  Not more than 1,0 % on a volatile matter free basis (800 °C)  
Aluminium oxide and/or silicon dioxide  Total not more than 2,0 %  
Matter soluble in 0,5 N HCl  Not more than 0,5 % on an alumina and silica-free basis and, in 
addition, for products containing alumina and/or silica, not more 
than 1,5 % on the basis of the product as sold.  
Water soluble matter  Not more than 0,5 %  
Cadmium  Not more than 1 mg/kg after an extraction with 0,5 N HCl.  
Antimony  Not more than 2 mg/kg after an extraction with 0,5 N HCl.  
Arsenic  Not more than 1 mg/kg after an extraction with 0,5 N HCl.  
Lead  Not more than 10 mg/kg after an extraction with 0,5 N HCl.  
Mercury  Not more than 1 mg/kg after an extraction with 0,5 N HCl.  
E 172 IRON OXIDES AND IRON HYDROXIDES 
Synonyms  Iron Oxide Yellow: CI Pigment Yellow 42 and 43  
Iron Oxide Red: CI Pigment Red 101 and 102  
Iron Oxide Black: CI Pigment Black 11  
Definition  Iron oxides and iron hydroxides are produced synthetically and 
consist essentially of anhydrous and/or hydrated iron oxides. The 
range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other 
metals. This is achieved by the selection and control of the source 
of the iron and/or by the extent of chemical purification during the manufacturing process.
 
Colour Index No  Iron Oxide Yellow:  77492  
Iron Oxide Red:  77491  
Iron Oxide Black:  77499  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 52
 
Einecs  Iron Oxide Yellow:  257-098-5  
Iron Oxide Red:  215-168-2  
Iron Oxide Black:  235-442-5  
Chemical name  Iron Oxide Yellow: hydrated ferric oxide, hydrated iron (III) oxide  
Iron Oxide Red: anhydrous ferric oxide, anhydrous iron (III) oxide  
Iron Oxide Black: ferroso ferric oxide, iron (II, III) oxide  
Chemical formula  Iron Oxide Yellow:  FeO(OH) · H 2 O 
Iron Oxide Red:  Fe  2 O 3 
Iron Oxide Black:  FeO.Fe  2 O 3 
Molecular weight  88,85:  FeO(OH)  
159,70:  Fe  2 O 3 
231,55:  FeO.Fe  2 O 3 
Assay  Yellow not less than 60 %, red and black not less than 68 % total 
iron, expressed as iron  
Description  Powder; yellow, red, brown or black in hue  
Identification  
Solubility  Insoluble in water and in organic solvents 
Soluble in concentrated mineral acids  
Purity  
Water soluble matter  Not more than 1,0 %  
By total dissolution  Arsenic  Not more than 3 mg/kg  
Cadmium  Not more than 1 mg/kg  
Chromium  Not more than 100 mg/kg  
Copper  Not more than 50 mg/kg  
Lead  Not more than 10 mg/kg  
Mercury  Not more than 1 mg/kg  
Nickel  Not more than 200 mg/kg  
Zinc Not more than 100 mg/kg  9 
> > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > = 
> > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > ;
 
E 173 ALUMINIUM 
Synonyms  CI Pigment Metal  
Definition  Aluminium powder is composed of finely divided particles of 
aluminium. The grinding may or may not be carried out in the 
presence of edible vegetable oils and/or food additive quality fatty 
acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids.
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 53
 
Colour Index No  77000  
Einecs  231-072-3  
Chemical name  Aluminium  
Chemical formula  Al  
Atomic weight  26,98  
Assay  Not less than 99 % calculated as Al on an oil-free basis  
Description  A silvery-grey powder or tiny sheets  
Identification  
Solubility  Insoluble in water and in organic solvents. Soluble in dilute hydro ­
chloric acid.  
Test for aluminium  A sample dissolved in dilute hydrochloric acid passes test  
Purity  
Loss on drying  Not more than 0,5 % (105 °C, to constant weight)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 10 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 174 SILVER 
Synonyms  Argentum  
Definition  
Colour Index No  77820  
Einecs  231-131-3  
Chemical name  Silver  
Chemical formula  Ag  
Atomic weight  107,87  
Assay  Content not less than 99,5 % Ag  
Description  Silver-coloured powder or tiny sheets  
Identification  
Purity  
E 175 GOLD 
Synonyms  Pigment Metal 3; Aurum  
Definition  
Colour Index No  77480  
Einecs  231-165-9  
Chemical name  Gold  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 54
 
Chemical formula  Au  
Atomic weight  197,0  
Assay  Content not less than 90 % Au  
Description  Gold-coloured powder or tiny sheets  
Identification  
Purity  
Silver  Not more than 7 %  After complete dissol ­
ution  Copper  Not more than 4 %  9 
> = 
> ; 
E 180 LITHOLRUBINE BK 
Synonyms  CI Pigment Red 57; Rubinpigment; Carmine 6B  
Definition  Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4- 
methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and 
subsidiary colouring matters together with water, calcium chloride and/or calcium sulphate as the principal uncoloured components.
 
Colour Index No  15850:1  
Einecs  226-109-5  
Chemical name  Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naph ­
thalene-carboxylate  
Chemical formula  C  18 H 12 CaN  2 O 6 S 
Molecular weight  424,45  
Assay  Content not less than 90 % total colouring matters  
E 1% 
1cm 200 at ca. 442 nm in dimethylformamide  
Description  Red powder  
Identification  
Spectrometry  Maximum in dimethylformamide at ca. 442 nm  
Purity  
Subsidiary colouring matters  Not more than 0,5 %  
Organic compounds other than colouring 
matters:  
2-Amino-5-methylbenzenesulfonic 
acid, calcium salt  Not more than 0,2 %  
3-hydroxy-2-naphthalenecarboxylic 
acid, calcium salt  Not more than 0,4 %  
Unsulfonated primary aromatic amines  Not more than 0,01 % (expressed as aniline)  
Ether extractable matter  From a solution of pH 7, not more than 0,2 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 55
 
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Aluminium lakes of this colour may be used.  
E 200 SORBIC ACID 
Synonyms  
Definition  
Einecs  203-768-7  
Chemical name  Sorbic acid;  trans , trans -2,4-Hexadienoic acid  
Chemical formula  C  6 H 8 O 2 
Molecular weight  112,12  
Assay  Content not less than 99 % on the anhydrous basis  
Description  Colourless needles or white free flowing powder, having a slight 
characteristic odour and showing no change in colour after heating for 90 minutes at 105 °C
 
Identification  
Melting range  Between 133 °C and 135 °C, after vacuum drying for four hours in a 
sulphuric acid desiccator  
Spectrometry  A propan-2-ol solution (1 in 4 000 000) shows absorbance maximum 
at 254 ± 2 nm  
Test for double bonds  Passes test  
Solubility  Slightly soluble in water, soluble in ethanol.  
Purity  
Water content  Not more than 0,5 % (Karl Fischer method)  
Sulphated ash  Not more than 0,2 %  
Aldehydes  Not more than 0,1 % (as formaldehyde)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 202 POTASSIUM SORBATE 
Synonyms  
Definition  
Einecs  246-376-1  
Chemical name  Potassium sorbate; Potassium (E,E)-2,4-hexadienoate; Potassium salt 
of trans , trans  2,4-hexadienoic acid  
Chemical formula  C  6 H 7 O 2 K 
Molecular weight  150,22  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 56
 
Assay  Content not less than 99 % on the dried basis  
Description  White crystalline powder showing no change in colour after heating 
for 90 minutes at 105 °C  
Identification  
Melting range for sorbic acid  Melting range of sorbic acid isolated by acidification and not recryst ­
allised 133 °C to 135 °C after vacuum drying in a sulphuric acid 
desiccator  
Test for potassium  Passes test  
Test for double bonds  Passes test  
Purity  
Loss on drying  Not more than 1,0 % (105 °C, 3 hours)  
Acidity or alkalinity  Not more than about 1,0 % (as sorbic acid or K  2 CO 3 ) 
Aldehydes  Not more than 0,1 %, calculated as formaldehyde  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 203 CALCIUM SORBATE 
Synonyms  
Definition  
Einecs  231-321-6  
Chemical name  Calcium sorbate; Calcium salts of  trans , trans -2,4-hexadienoic acid  
Chemical formula  C  12 H 14 O 4 Ca 
Molecular weight  262,32  
Assay  Content not less than 98 % on the dried basis  
Description  Fine white crystalline powder not showing any change in colour 
after heating at 105 °C for 90 minutes  
Identification  
Melting range for sorbic acid  Melting range of sorbic acid isolated by acidification and not recryst ­
allised 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator
 
Test for calcium  Passes test  
Test for double bonds  Passes test  
Purity  
Loss on drying  Not more than 2,0 %, determined by vacuum drying for four hours 
in a sulphuric acid desiccator  
Aldehydes  Not more than 0,1 % (as formaldehyde)  
Fluoride  Not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 57
 
E 210 BENZOIC ACID 
Synonyms  
Definition  
Einecs  200-618-2  
Chemical name  Benzoic acid; Benzenecarboxylic acid; Phenylcarboxylic acid  
Chemical formula  C  7 H 6 O 2 
Molecular weight  122,12  
Assay  Content not less than 99,5 % on the anhydrous basis  
Description  White crystalline powder  
Identification  
Melting range  121,5 °C -123,5 °C  
Sublimation test  Passes test  
Test for benzoate  Passes test  
pH About 4 (solution in water)  
Purity  
Loss on drying  Not more than 0,5 % (3 hours, over sulphuric acid)  
Sulphated ash  Not more than 0,05 %  
Chlorinated organic compounds  Not more than 0,07 % expressed as chloride corresponding to 0,3 % 
expressed as monochlorobenzoic acid  
Readily oxidisable substances  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling 
point and add 0,1 N KMnO  4 in drops, until the pink colour persists 
for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest 
mg, in the heated solution, and titrate with 0,1 N KMnO  4 to a pink 
colour that persists for 15 seconds. Not more than 0,5 ml should be required
 
Readily carbonisable substances  A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % 
sulphuric acid must not show a stronger colouring than that of a 
reference liquid containing 0,2 ml of cobalt chloride TSC (  1 ), 0,3 ml 
of ferric chloride TSC (  2 ), 0,1 ml of copper sulphate TSC (  3 ) and 
4,4 ml of water  
Polycyclic acids  On fractional acidification of a neutralised solution of benzoic acid, 
the first precipitate must not have a different melting point from that 
of the benzoic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
_____________ 
( 1 ) Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl  2 ·6H 2 O in a sufficient quantity of a mixture of 25 ml 
hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottome d flask 
containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boi l 
for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completel y 
dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulph ate 
(0,1 N) corresponds to 23,80 mg of CoCl  2 ·6H 2 O. Adjust final volume of solution by the addition of a sufficient quantity of the 
hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl  2 ·6H 2 O per ml. 
( 2 ) Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydroch loric 
acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 2 50 ml 
of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of 
water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulph ate 
(0,1 N) corresponds to 27,03 mg of FeCl  3 ·6H 2 O. Adjust final volume of solution by the addition of a sufficient quantity of the 
hydrochloric acid/water to give a solution containing 45,0 mg of FeCl  3 ·6H 2 O per ml. 
( 3 ) Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO  4 ·5H 2 O in a sufficient quantity of a mixture of 25 ml 
of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed fl ask 
containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberate d 
iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (*). 1 ml of sodium thiosulphate (0,1 N) corresponds to 
24,97 mg of CuSO  4 ·5H 2 O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water 
mixture to give a solution containing 62,4 mg of CuSO  4 ·5H 2 O per ml. 
(*) Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluable starch) with 5 ml of water; to the resulting pas te add a 
sufficient quantity of water to give a total volume of 100 ml, stirring all the time. Boil for a few minutes, allow to cool, fi lter. The 
starch must be freshly prepared.  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 58
 
E 211 SODIUM BENZOATE 
Synonyms  
Definition  
Einecs  208-534-8  
Chemical name  Sodium benzoate; Sodium salt of benzenecarboxylic acid; Sodium 
salt of phenylcarboxylic acid  
Chemical formula  C  7 H 5 O 2 Na 
Molecular weight  144,11  
Assay  Not less than 99 % of C  7 H 5 O 2 Na, after drying at 105 °C for four 
hours  
Description  A white, almost odourless, crystalline powder or granules  
Identification  
Solubility  Freely soluble in water, sparingly soluble in ethanol  
Melting range for benzoic acid  Melting range of benzoic acid isolated by acidification and not 
recrystallised 121,5 °C to 123,5 °C, after drying in a sulphuric 
acid desiccator  
Test for benzoate  Passes test  
Test for sodium  Passes test  
Purity  
Loss on drying  Not more than 1,5 % (105 °C, 4 hours)  
Readily oxidisable substances  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling 
point and add 0,1 N KMnO  4 in drops, until the pink colour persists 
for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO
 4 to a pink 
colour that persists for 15 seconds. Not more than 0,5 ml should be 
required  
Polycyclic acids  On fractional acidification of a (neutralised) solution of sodium 
benzoate, the first precipitate must not have a different melting range from that of benzoic acid
 
Chlorinated organic compounds  Not more than 0,06 % expressed as chloride, corresponding to 
0,25 % expressed as monochlorobenzoic acid  
Acidity or alkalinity  Neutralisation of 1 g of sodium benzoate, in the presence of 
phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 212 POTASSIUM BENZOATE 
Synonyms  
Definition  
Einecs  209-481-3  
Chemical name  Potassium benzoate; Potassium salt of benzenecarboxylic acid; 
Potassium salt of phenylcarboxylic acid  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 59
 
Chemical formula  C  7 H 5 KO  2 ·3H 2 O 
Molecular weight  214,27  
Assay  Content not less than 99 % C  7 H 5 KO  2 after drying at 105 °C to 
constant weight  
Description  White crystalline powder  
Identification  
Melting range for benzoic acid  Melting range of benzoic acid isolated by acidification and not 
recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a 
sulphuric acid desiccator  
Test for benzoate  Passes test  
Test for potassium  Passes test  
Purity  
Loss on drying  Not more than 26,5 % (105 °C, 4 hours)  
Chlorinated organic compounds  Not more than 0,06 % expressed as chloride, corresponding to 
0,25 % expressed as monochlorobenzoic acid  
Readily oxidisable substances  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling 
point and add 0,1 N KMnO  4 in drops, until the pink colour persists 
for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO
 4 to a pink 
colour that persists for 15 seconds. Not more than 0,5 ml should be 
required  
Readily carbonisable substances  A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % 
sulphuric acid must not show a stronger colouring than that of a 
reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
 
Polycyclic acids  On fractional acidification of a (neutralised) solution of potassium 
benzoate, the first precipitate must not have a different melting range from that of benzoic acid
 
Acidity or alkalinity  Neutralisation of 1 g of potassium benzoate, in the presence of 
phenolphthalein, must not require more than 0,25 ml of 0,1 N 
NaOH or 0,1 N HCl  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 213 CALCIUM BENZOATE 
Synonyms  Monocalcium benzoate  
Definition  
Einecs  218-235-4  
Chemical name  Calcium benzoate; Calcium dibenzoate  
Chemical formula  Anhydrous:  C  14 H 10 O 4 Ca 
Monohydrate:  C  14 H 10 O 4 Ca·H 2 O 
Trihydrate:  C  14 H 10 O 4 Ca·3H 2 O ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 60
 
Molecular weight  Anhydrous:  282,31  
Monohydrate:  300,32  
Trihydrate:  336,36  
Assay  Content not less than 99 % after drying at 105 °C  
Description  White or colourless crystals, or white powder  
Identification  
Melting range for benzoic acid  Melting range of benzoic acid isolated by acidification and not 
recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator
 
Test for benzoate  Passes test  
Test for calcium  Passes test  
Purity  
Loss on drying  Not more than 17,5 % (105 °C, to constant weight)  
Water insoluble matter  Not more than 0,3 %  
Chlorinated organic compounds  Not more than 0,06 % expressed as chloride, corresponding to 
0,25 % expressed as monochlorobenzoic acid  
Readily oxidisable substances  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling 
point and add 0,1 N KMnO  4 in drops, until the pink colour persists 
for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest 
mg, in the heated solution, and titrate with 0,1 N KMnO  4 to a pink 
colour that persists for 15 seconds. Not more than 0,5 ml should be required
 
Readily carbonisable substances  Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % 
sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of 
ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of 
water
 
Polycyclic acids  On fractional acidification of a (neutralised) solution of calcium 
benzoate, the first precipitate must not be a different melting 
range from that of benzoic acid  
Acidity or alkalinity  Neutralisation of 1 g of calcium benzoate, in the presence of 
phenolphthalein, must not require more than 0,25 ml of 0,1 N 
NaOH or 0,1 N HCl  
Fluoride  Not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 214 ETHYL p-HYDROXYBENZOATE 
Synonyms  Ethylparaben; Ethyl  p-oxybenzoate  
Definition  
Einecs  204-399-4  
Chemical name  Ethyl- p-hydroxybenzoate; Ethyl ester of  p-hydroxybenzoic acid  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 61
 
Chemical formula  C  9 H 10 O 3 
Molecular weight  166,8  
Assay  Content not less than 99,5 % after drying for two hours at 80 °C  
Description  Almost odourless, small, colourless crystals or a white, crystalline 
powder  
Identification  
Melting range  115-118 °C  
Test for  p-hydroxybenzoate  Melting range of  p-hydroxybenzoic acid isolated by acidification and 
not recrystallised: 213 °C to 217 °C, after vacuum drying in a sulphuric acid desiccator
 
Test for alcohol  Passes test  
Purity  
Loss on drying  Not more than 0,5 % (80 °C, 2 hours)  
Sulphated ash  Not more than 0,05 %  
p-Hydroxybenzoic acid and salicylic acid  Not more than 0,35 % expressed as  p-hydroxybenzoic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 215 SODIUM ETHYL p-HYDROXYBENZOATE 
Synonyms  
Definition  
Einecs  252-487-6  
Chemical name  Sodium ethyl  p-hydroxybenzoate; Sodium compound of the ethyl 
ester of  p-hydroxybenzoic acid  
Chemical formula  C  9 H 9 O 3 Na 
Molecular weight  188,8  
Assay  Content of ethylester of  p-hydroxybenzoic acid not less than 83 % 
on the anhydrous basis  
Description  White, crystalline hygroscopic powder  
Identification  
Melting range  115 °C to 118 °C, after vacuum drying in a sulphuric acid desiccator  
Test for  p-hydroxybenzoate  Melting range of  p-hydroxybenzoic acid derived from the sample is 
213 °C to 217 °C  
Test for sodium  Passes test  
pH 9,9-10,3 (0,1 % aqueous solution)  
Purity  
Loss on drying  Not more than 5 %, (by vacuum drying in a sulphuric acid desic ­
cator)  
Sulphated ash  37 to 39 %  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 62
 
p-Hydroxybenzoic acid and salicylic acid  Not more than 0,35 % expressed as  p-hydroxybenzoic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 218 METHYL p-HYDROXYBENZOATE 
Synonyms  Methylparaben; Methyl- p-oxybenzoate  
Definition  
Einecs  243-171-5  
Chemical name  Methyl  p-hydroxybenzoate; Methyl ester of  p-hydroxybenzoic acid  
Chemical formula  C  8 H 8 O 3 
Molecular weight  152,15  
Assay  Content not less than 99 % after drying for two hours at 80 °C  
Description  Almost odourless, small colourless crystals or white crystalline 
powder  
Identification  
Melting range  125 °C - 128 °C  
Test for  p-hydroxybenzoate  Melting range of  p-hydroxybenzoic acid derived from the sample is 
213 °C to 217 °C after drying for two hours at 80 °C  
Purity  
Loss on drying  Not more than 0,5 % (80 °C, 2 hours)  
Sulphated ash  Not more than 0,05 %  
p-Hydroxybenzoic acid and salicylic acid  Not more than 0,35 % expressed as  p-hydroxybenzoic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 219 SODIUM METHYL p-HYDROXYBENZOATE 
Synonyms  
Definition  
Einecs  
Chemical name  Sodium methyl  p-hydroxybenzoate; Sodium compound of the 
methylester of  p-hydroxybenzoic acid  
Chemical formula  C  8 H 7 O 3 Na 
Molecular weight  174,15  
Assay  Content not less than 99,5 % on the anhydrous basis  
Description  White, hygroscopic powder  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 63
 
Identification  
Melting range  The white precipitate formed by acidifying with hydrochloric acid a 
10 % (w/v) aqueous solution of the sodium derivative of methyl  p- 
hydroxybenzoate (using litmus paper as indicator) shall, when 
washed with water and dried at 80 °C for two hours, have a melting range of 125 °C to 128 °C
 
Test for sodium  Passes test  
pH 9,7-10,3 (0,1 % solution in carbon dioxide free water)  
Purity  
Water content  Not more than 5 % (Karl Fischer method)  
Sulphated ash  40 % to 44,5 % on the anhydrous basis  
p-Hydroxybenzoic acid and salicylic acid  Not more than 0,35 % expressed as  p-hydroxybenzoic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 220 SULPHUR DIOXIDE 
Synonyms  
Definition  
Einecs  231-195-2  
Chemical name  Sulphur dioxide; Sulphurous acid anhydride  
Chemical formula  SO  2 
Molecular weight  64,07  
Assay  Content not less than 99 %  
Description  Colourless, non-flammable gas with strong pungent suffocating 
odour  
Identification  
Test for sulphurous substances  Passes test  
Purity  
Water content  Not more than 0,05 % (Karl Fischer method)  
Non-volatile residue  Not more than 0,01 %  
Sulphur trioxide  Not more than 0,1 %  
Selenium  Not more than 10 mg/kg  
Other gases not normally present in the 
air No trace  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 64
 
E 221 SODIUM SULPHITE 
Synonyms  
Definition  
Einecs  231-821-4  
Chemical name  Sodium sulphite (anhydrous or heptahydrate)  
Chemical formula  Anhydrous:  Na  2 SO 3 
Heptahydrate:  Na  2 SO 3 7H 2 O 
Molecular weight  Anhydrous:  126,04  
Heptahydrate:  252,16  
Assay  Anhydrous:  Not less than 95 % of 
Na 2 SO 3 and not less than 
48 % of SO  2 
Heptahydrate:  Not less than 48 % of 
Na 2 SO 3 and not less than 
24 % of SO  2 
Description  White crystalline powder or colourless crystals  
Identification  
Test for sulphite  Passes test  
Test for sodium  Passes test  
pH 8,5-11,5 (anhydrous: 10 % solution; heptahydrate: 20 % solution)  
Purity  
Thiosulphate  Not more than 0,1 % based on the SO  2 content  
Iron Not more than 10 mg/kg based on the SO  2 content  
Selenium  Not more than 5 mg/kg based on the SO  2 content  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
▼M3 
E 222 SODIUM HYDROGEN SULPHITE  
▼B 
Synonyms  
Definition  
Einecs  231-921-4  
Chemical name  Sodium bisulphite; Sodium hydrogen sulphite  
Chemical formula  NaHSO  3 in aqueous solution  
Molecular weight  104,06  
Assay  Content not less than 32 % w/w NaHSO  3 
Description  A clear, colourless to yellow solution  
Identification  
Test for sulphite  Passes test  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 65
 
Test for sodium  Passes test  
pH 2,5-5,5 (10 % aqueous solution)  
Purity  
▼M3 
Iron Not more than 10 mg/kg based on the SO  2 content  
▼B 
Selenium  Not more than 5 mg/kg based on the SO  2 content  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 223 SODIUM METABISULPHITE 
Synonyms  Pyrosulphite; Sodium pyrosulphite  
Definition  
Einecs  231-673-0  
Chemical name  Sodium disulphite; Disodium pentaoxodisulphate  
Chemical formula  Na  2 S 2 O 5 
Molecular weight  190,11  
Assay  Content not less than 95 % Na  2 S 2 O 5 and not less than 64 % of SO  2 
Description  White crystals or crystalline powder  
Identification  
Test for sulphite  Passes test  
Test for sodium  Passes test  
pH 4,0-5,5 (10 % aqueous solution)  
Purity  
Thiosulphate  Not more than 0,1 % based on the SO  2 content  
Iron Not more than 10 mg/kg based on the SO  2 content  
Selenium  Not more than 5 mg/kg based on the SO  2 content  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 224 POTASSIUM METABISULPHITE 
Synonyms  Potassium pyrosulphite  
Definition  
Einecs  240-795-3  
Chemical name  Potassium disulphite; Potassium pentaoxo disulphate  
Chemical formula  K  2 S 2 O 5 
Molecular weight  222,33  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 66
 
Assay  Content not less than 90 % K  2 S 2 O 5 and not less than 51,8 % of SO  2 , 
the remainder being composed almost entirely of potassium sulphate  
Description  Colourless crystals or white crystalline powder  
Identification  
Test for sulphite  Passes test  
Test for potassium  Passes test  
Purity  
Thiosulphate  Not more than 0,1 % based on the SO  2 content  
Iron Not more than 10 mg/kg based on the SO  2 content  
Selenium  Not more than 5 mg/kg based on the SO  2 content  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 226 CALCIUM SULPHITE 
Synonyms  
Definition  
Einecs  218-235-4  
Chemical name  Calcium sulphite  
Chemical formula  CaSO  3 ·2H 2 O 
Molecular weight  156,17  
Assay  Content not less than 95 % of CaSO  3 ·2H 2 O and not less than 39 % 
of SO  2 
Description  White crystals or white crystalline powder  
Identification  
Test for sulphite  Passes test  
Test for calcium  Passes test  
Purity  
Iron Not more than 10 mg/kg based on the SO  2 content  
Selenium  Not more than 5 mg/kg based on the SO  2 content  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
▼M8 
E 227 CALCIUM HYDROGEN SULPHITE  
▼B 
Synonyms  
Definition  
Einecs  237-423-7  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 67
 
Chemical name  Calcium bisulphite; Calcium hydrogen sulphite  
Chemical formula  Ca(HSO  3 ) 2 
Molecular weight  202,22  
Assay  6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium 
dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO
 3 ) 2 ] 
Description  Clear greenish-yellow aqueous solution having a distinct odour of 
sulphur dioxide  
Identification  
Test for sulphite  Passes test  
Test for calcium  Passes test  
Purity  
Iron Not more than 10 mg/kg based on the SO  2 content  
Selenium  Not more than 5 mg/kg based on the SO  2 content  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
▼M8 
E 228 POTASSIUM HYDROGEN SULPHITE  
▼B 
Synonyms  
Definition  
Einecs  231-870-1  
Chemical name  Potassium bisulphite; Potassium hydrogen sulphite  
Chemical formula  KHSO  3 in aqueous solution  
Molecular weight  120,17  
Assay  Content not less than 280 g KHSO  3 per litre (or 150 g SO  2 per litre)  
Description  Clear colourless aqueous solution  
Identification  
Test for sulphite  Passes test  
Test for potassium  Passes test  
Purity  
Iron Not more than 10 mg/kg based on the SO  2 content  
Selenium  Not more than 5 mg/kg based on the SO  2 content  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 68
 
E 234 NISIN 
Synonyms  
Definition  Nisin consists of several closely related polypeptides produced by 
strains of  Lactococcus lactis  subsp.  lactis  
Einecs  215-807-5  
Chemical name  
Chemical formula  C  143 H 230 N 42 O 37 S 7 
Molecular weight  3 354,12  
Assay  Nisin concentrate contains not less than 900 units per mg in a 
mixture of non-fat milk solids and a minimum sodium chloride 
content of 50 %  
Description  White powder  
Identification  
Purity  
Loss on drying  Not more than 3 % (102 °C to 103 °C, to constant weight)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 235 NATAMYCIN 
Synonyms  Pimaricin  
Definition  Natamycin is a fungicide of the polyene macrolide group, and is 
produced by strains of  Streptomyces natalensis  and other relevant 
species  
Einecs  231-683-5  
Chemical name  A stereoisomer of 22-(3-Amino-3,6-dideoxy- β-D- mannopyr ­
anosyloxy)-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatri ­
cyclo[22.3.1.0  5,7 ]octacosa-8,14,16,18,20-pentaene-25-carboxylic 
acid.  
Chemical formula  C  33 H 47 O 13 N 
Molecular weight  665,74  
Assay  Content not less than 95 % on the dried basis  
Description  White to creamy-white crystalline powder  
Identification  
Colour reactions  On adding a few crystals of natamycin on a spot plate, to a drop of: 
concentrated hydrochloric acid, a blue colour develops, 
concentrated phosphoric acid, a green colour develops,which 
changes into pale red after a few minutes  
Spectrometry  A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has 
absorption maxima at about 290 nm, 303 nm and 318 nm, a 
shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 69
 
pH 5,5-7,5 (1 % w/v solution in previously neutralised mixture of 20 
parts dimethylformamide and 80 parts of water)  
Specific rotation  [ α] D 20 + 250° to + 295° (a 1 % w/v solution in glacial acetic acid, at 
20 °C and calculated with reference to the dried material)  
Purity  
Loss on drying  Not more than 8 % (over P  2 O 5 , in vacuum at 60 °C to constant 
weight)  
Sulphated ash  Not more than 0,5 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 100 colonies per gram  
E 239 HEXAMETHYLENE TETRAMINE 
Synonyms  Hexamine; Methenamine  
Definition  
Einecs  202-905-8  
Chemical name  1,3,5,7-Tetraazatricyclo [3.3.1.1  3,7 ]-decane, hexamethylenetetramine  
Chemical formula  C  6 H 12 N 4 
Molecular weight  140,19  
Assay  Content not less than 99 % on the anhydrous basis  
Description  Colourless or white crystalline powder  
Identification  
Test for formaldehyde  Passes test  
Test for ammonia  Passes test  
Sublimation point:  Approximately 260 °C  
Purity  
Loss on drying  Not more than 0,5 % (at 105 °C in vacuum over P  2 O 5 for 2 hours)  
Sulphated ash  Not more than 0,05 %  
Sulphates  Not more than 0,005 % expressed as SO  4 
Chlorides  Not more than 0,005 % expressed as Cl  
Ammonium salts  Not detectable  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 70
 
E 242 DIMETHYL DICARBONATE 
Synonyms  DMDC; Dimethyl pyrocarbonate  
Definition  
Einecs  224-859-8  
Chemical name  Dimethyl dicarbonate; Pyrocarbonic acid dimethyl ester  
Chemical formula  C  4 H 6 O 5 
Molecular weight  134,09  
Assay  Content not less than 99,8 %  
Description  Colourless liquid, decomposes in aqueous solution. It is corrosive to 
skin and eyes and toxic by inhalation and ingestion  
Identification  
Decomposition  After dilution positive tests for CO  2 and methanol  
Melting point  17 °C  
Boiling point  172 °C with decomposition  
Density 20 °C  Approximately 1,25 g/cm  3 
Infrared absorption spectrum  Maxima at 1 156 and 1 832 cm  -1 
Purity  
Dimethyl carbonate  Not more than 0,2 %  
Chlorine, total  Not more than 3 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
▼M12  
E 243 ETHYL LAUROYL ARGINATE 
Synonyms  Lauric arginate ethyl ester; lauramide arginine ethyl ester; ethyl- Να- 
lauroyl-L-arginate ·HCl; LAE;  
Definition  Ethyl lauroyl arginate is synthesized by esterifying arginine with 
ethanol, followed by reacting the ester with lauroyl chloride. The resultant ethyl lauroyl arginate is recovered as the hydrochloride salt, which is filtered and dried.
 
ELINCS  434-630-6  
Chemical name  Ethyl- Να-dodecanoyl-L-arginate ·HCl 
Chemical formula  C20H41N4O3Cl  
Molecular Weight  421,02  
Assay  Not less than 85 % and not more than 95 %  
Description  White powder  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 71
 
Identification  
Solubility  Freely soluble in water, ethanol, propylene glycol and glycerol  
Purity  
Να-Lauroyl-L-arginine  Not more than 3 %  
Lauric acid  Not more than 5 %  
Ethyl laurate  Not more than 3 %  
L-Arginine ·HCl Not more than 1 %  
Ethyl arginate ·2HCl  Not more than 1 %  
Lead  Not more than 1 mg/kg  
Arsenic  Not more than 3 mg/kg  
Cadmium  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
▼B 
E 249 POTASSIUM NITRITE 
Synonyms  
Definition  
Einecs  231-832-4  
Chemical name  Potassium nitrite  
Chemical formula  KNO  2 
Molecular weight  85,11  
Assay  Content not less than 95 % on the anhydrous basis (  1 ) 
Description  White or slightly yellow, deliquescent granules  
Identification  
Test for nitrite  Passes test  
Test for potassium  Passes test  
pH 6,0-9,0 (5 % solution)  
_____________  
( 1 ) May only be sold in a mixture with salt or a salt substitute.  ▼M12  2012R0231 — EN — 11.07.2014 — 008.001 — 72
 
Purity  
Loss on drying  Not more than 3 % (4 hours, over silica gel)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 250 SODIUM NITRITE 
Synonyms  
Definition  
Einecs  231-555-9  
Chemical name  Sodium nitrite  
Chemical formula  NaNO  2 
Molecular weight  69,00  
Assay  Content not less than 97 % on the anhydrous basis (  1 ) 
Description  White crystalline powder or yellowish lumps  
Identification  
Test for nitrite  Passes test  
Test for sodium  Passes test  
Purity  
Loss on drying  Not more than 0,25 % (4 hours, over silica gel)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 251 SODIUM NITRATE  
(i) SOLID SODIUM NITRATE  
Synonyms  Chile saltpetre; Cubic or soda nitre  
Definition  
Einecs  231-554-3  
Chemical name  Sodium nitrate  
Chemical formula  NaNO  3 
Molecular weight  85,00  
Assay  Content not less than 99 % on the anhydrous basis  
Description  White crystalline, slightly hygroscopic powder  
_____________  
( 1 ) May only be sold in a mixture with salt or a salt substitute.  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 73
 
Identification  
Test for nitrate  Passes test  
Test for sodium  Passes test  
pH 5,5-8,3 (5 % solution)  
Purity  
Loss on drying  Not more than 2 % (105 °C, 4 hours)  
Nitrites  Not more than 30 mg/kg expressed as NaNO  2 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
(ii) LIQUID SODIUM NITRATE  
Synonyms  
Definition  Liquid sodium nitrate is an aqueous solution of sodium nitrate as the 
direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystalli ­
sation. Standardised forms prepared from liquid sodium nitrate 
meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.
 
Einecs  231-554-3  
Chemical name  Sodium nitrate  
Chemical formula  NaNO  3 
Molecular weight  85,00  
Assay  Content between 33,5 % and 40,0 % of NaNO  3 
Description  Clear colourless liquid  
Identification  
Test for nitrate  Passes test  
Test for sodium  Passes test  
pH 1,5-3,5  
Purity  
Free nitric acid  Not more than 0,01 %  
Nitrites  Not more than 10 mg/kg expressed as NaNO  2 
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 0,3 mg/kg  
This specification refers to a 35 % aqueous solution.  
E 252 POTASSIUM NITRATE 
Synonyms  Chile saltpetre; Cubic or soda nitre  
Definition  
Einecs  231-818-8  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 74
 
Chemical name  Potassium nitrate  
Chemical formula  KNO  3 
Molecular weight  101,11  
Assay  Content not less than 99 % on the anhydrous basis  
Description  White crystalline powder or transparent prisms having a cooling, 
saline, pungent taste  
Identification  
Test for nitrate  Passes test  
Test for potassium  Passes test  
pH 4,5-8,5 (5 % solution)  
Purity  
Loss on drying  Not more than 1 % (105 °C, 4 hours)  
Nitrites  Not more than 20 mg/kg expressed as KNO  2 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 260 ACETIC ACID 
Synonyms  
Definition  
Einecs  200-580-7  
Chemical name  Acetic acid; Ethanoic acid  
Chemical formula  C  2 H 4 O 2 
Molecular weight  60,05  
Assay  Content not less than 99,8 %  
Description  Clear, colourless liquid having a pungent, characteristic odour  
Identification  
Boiling point  118 °C at 760 mm pressure (of mercury)  
Specific gravity  About 1,049  
Test for acetate  A one in three solution gives positive tests for acetate  
Solidification point  Not lower than 14,5 °C  
Purity  
Non-volatile residue  Not more than 100 mg/kg  
Formic acid, formates and other 
oxidisable substances  Not more than 1 000 mg/kg expressed as formic acid  
Readily oxidisable substances  Dilute 2 ml of the sample in a glass-stoppered container with 10 ml 
of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 75
 
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 0,5 mg/kg  
Mercury  Not more than 1 mg/kg  
▼M2 
E 261 (i) POTASSIUM ACETATE  
▼B 
Synonyms  
Definition  
Einecs  204-822-2  
Chemical name  Potassium acetate  
Chemical formula  C  2 H 3 O 2 K 
Molecular weight  98,14  
Assay  Content not less than 99 % on the anhydrous basis  
Description  Colourless, deliquescent crystals or a white crystalline powder, 
odourless or with a faint acetic odour  
Identification  
pH 7,5-9,0 (5 % aqueous solution)  
Test for acetate  Passes test  
Test for potassium  Passes test  
Purity  
Loss on drying  Not more than 8 % (150 °C, 2 hours)  
Formic acid, formates and other 
oxidisable substances  Not more than 1 000 mg/kg expressed as formic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
▼M2 
E 261 (ii) POTASSIUM DIACETATE 
Synonyms  
Definition  Potassium diacetate is a molecular compound of potassium acetate 
and acetic acid  
Einecs  224-217-7  
Chemical name  Potassium hydrogen diacetate  
Chemical formula  C  4 H 7 KO  4 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 76
 
Molecular weight  158,2  
Assay  Content 36 to 38 % of free acetic acid and 61 to 64 % of potassium 
acetate  
Description  White crystals  
Identification  
pH 4,5-5 (10 % aqueous solution)  
Test for acetate  Passes test  
Test for potassium  Passes test  
Purity  
Water content  Not more than 1 % (Karl Fischer method)  
Formic acid, formates and other 
oxidisable substances  Not more than 1 000 mg/kg expressed as formic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
▼B 
E 262 (i) SODIUM ACETATE 
Synonyms  
Definition  
Einecs  204-823-8  
Chemical name  Sodium acetate  
Chemical formula  C  2 H 3 NaO  2 ·nH 2 O (n = 0 or 3)  
Molecular weight  Anhydrous:  82,03  
Trihydrate:  136,08  
Assay  Content (for both of anhydrous and trihydrate form) not less than 
98,5 % on the anhydrous basis  
Description  Anhydrous:  White, odourless, granular, hygro ­
scopic powder  
Trihydrate:  Colourless, transparent crystals or a 
granular crystalline powder, 
odourless or with a faint, acetic odour. Effloresces in warm, dry air
 ▼M2 2012R0231 — EN — 11.07.2014 — 008.001 — 77
 
Identification  
pH 8,0-9,5 (1 % aqueous solution)  
Test for acetate  Passes test  
Test for sodium  Passes test  
Purity  
Loss on drying  Anhydrous:  Not more than 2 % (120 °C, 4 
hours)  
Trihydrate:  Between 36 and 42 % (120 °C, 4 
hours)  
Formic acid, formates and other 
oxidisable substances  Not more than 1 000 mg/kg expressed as formic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 262 (ii) SODIUM DIACETATE 
Synonyms  
Definition  Sodium diacetate is a molecular compound of sodium acetate and 
acetic acid  
Einecs  204-814-9  
Chemical name  Sodium hydrogen diacetate  
Chemical formula  C  4 H 7 NaO  4 ·nH 2 O (n = 0 or 3)  
Molecular weight  142,09 (anhydrous)  
Assay  Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium 
acetate  
Description  White, hygroscopic crystalline solid with an acetic odour  
Identification  
pH 4,5-5,0 (10 % aqueous solution)  
Test for acetate  Passes test  
Test for sodium  Passes test  
Purity  
Water content  Not more than 2 % (Karl Fischer method)  
Formic acid, formates and other 
oxidisable substances  Not more than 1 000 mg/kg expressed as formic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 263 CALCIUM ACETATE 
Synonyms  
Definition  
Einecs  200-540-9  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 78
 
Chemical name  Calcium acetate  
Chemical formula  Anhydrous:  C  4 H 6 O 4 Ca 
Monohydrate:  C  4 H 6 O 4 Ca·H 2 O 
Molecular weight  Anhydrous:  158,17  
Monohydrate:  176,18  
Assay  Content not less than 98 % on the anhydrous basis  
Description  Anhydrous calcium acetate is a white, hygroscopic, bulky, 
crystalline solid with a slightly bitter taste. A slight odour of 
acetic acid may be present. The monohydrate may be needles, 
granules or powder  
Identification  
pH 6,0-9,0 (10 % aqueous solution)  
Test for acetate  Passes test  
Test for calcium  Passes test  
Purity  
Loss on drying  Not more than 11 % (155 °C to constant weight, for the monohy ­
drate)  
Water insoluble matter  Not more than 0,3 %  
Formic acid, formates and other 
oxidisable substances  Not more than 1 000 mg/kg expressed as formic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 270 LACTIC ACID 
Synonyms  
Definition  Consists of a mixture of lactic acid (C  3 H 6 O 3 ) and lactic acid lactate 
(C 6 H 10 O 5 ). It is obtained by the lactic fermentation of sugars or is 
prepared synthetically. 
Lactic acid is hygroscopic and when concentrated by boiling, it 
condenses to form lactic acid lactate, which on dilution and heating hydrolyses to lactic acid.
 
Einecs  200-018-0  
Chemical name  Lactic acid; 2-Hydroxypropionic acid; 1-Hydroxyethane-1-carboxylic 
acid 
Chemical formula  C  3 H 6 O 3 
Molecular weight  90,08  
Assay  Content not less than 76 %  
Description  Colourless or yellowish, nearly odourless, syrupy liquid to solid  
Identification  
Test for lactate  Passes test  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 79
 
Purity  
Sulphated ash  Not more than 0,1 %  
Chloride  Not more than 0,2 %  
Sulphate  Not more than 0,25 %  
Iron Not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Note:  This specification refers to a 80 % aqueous solution; for weaker aqueous 
solutions, calculate values corresponding to their lactic acid content  
E 280 PROPIONIC ACID 
Synonyms  
Definition  
Einecs  201-176-3  
Chemical name  Propionic acid; Propanoic acid  
Chemical formula  C  3 H 6 O 2 
Molecular weight  74,08  
Assay  Content not less than 99,5 %  
Description  Colourless or slightly yellowish, oily liquid with a slightly pungent 
odour  
Identification  
Melting point  – 22 °C  
Distillation range  138,5 °C to 142,5 °C  
Purity  
Non-volatile residue  Not more than 0,01 % when dried at 140 °C to constant weight  
Aldehydes  Not more than 0,1 % expressed as formaldehyde  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 281 SODIUM PROPIONATE 
Synonyms  
Definition  
Einecs  205-290-4  
Chemical name  Sodium propionate; Sodium propanoate  
Chemical formula  C  3 H 5 O 2 Na 
Molecular weight  96,06  
Assay  Content not less than 99 % after drying for two hours at 105 °C  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 80
 
Description  White crystalline hygroscopic powder, or a fine white powder  
Identification  
Test for propionate  Passes test  
Test for sodium  Passes test  
pH 7,5-10,5 (10 % aqueous solution)  
Purity  
Loss on drying  Not more than 4 % (105 °C, 2 hours)  
Water insoluble matter  Not more than 0,1 %  
Iron Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 282 CALCIUM PROPIONATE 
Synonyms  
Definition  
Einecs  223-795-8  
Chemical name  Calcium propionate  
Chemical formula  C  6 H 10 O 4 Ca 
Molecular weight  186,22  
Assay  Content not less than 99 %, after drying for two hours at 105 °C  
Description  White crystalline powder  
Identification  
Test for propionate  Passes test  
Test for calcium  Passes test  
pH 6,0-9,0 (10 % aqueous solution)  
Purity  
Loss on drying  Not more than 4 % (105 °C, 2 hours)  
Water insoluble matter  Not more than 0,3 %  
Iron Not more than 50 mg/kg  
Fluoride  Not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 283 POTASSIUM PROPIONATE 
Synonyms  
Definition  
Einecs  206-323-5  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 81
 
Chemical name  Potassium propionate; Potassium propanoate  
Chemical formula  C  3 H 5 KO  2 
Molecular weight  112,17  
Assay  Content not less than 99 % after drying for two hours at 105 °C  
Description  White crystalline powder  
Identification  
Test for propionate  Passes test  
Test for potassium  Passes test  
Purity  
Loss on drying  Not more than 4 % (105 °C, 2 hours)  
Water insoluble matter  Not more than 0,1 %  
Iron Not more than 30 mg/kg  
Fluoride  Not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 284 BORIC ACID 
Synonyms  Boracic acid; Orthoboric acid; Borofax  
Definition  
Einecs  233-139-2  
Chemical name  
Chemical formula  H  3 BO 3 
Molecular weight  61,84  
Assay  Content not less than 99,5 %  
Description  Colourless, odourless, transparent crystals or white granules or 
powder; slightly unctuous to the touch; occurs in nature as the 
mineral sassolite  
Identification  
Melting point  At approximately 171 °C  
Burning test  Burns with a nice green flame  
pH 3,8-4,8 (3,3 % aqueous solution)  
Purity  
Peroxides  No colour develops with added KI-solution  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 82
 
E 285 SODIUM TETRABORATE (BORAX) 
Synonyms  Sodium borate  
Definition  
Einecs  215-540-4  
Chemical name  Sodium tetraborate; Sodium biborate; Sodium pyroborate; 
Anhydrous tetraborate  
Chemical formula  Na  2 B 4 O 7 
Na 2 B 4 O 7 ·10H  2 O 
Molecular weight  201,27  
Assay  
Description  Powder or glass-like plates becoming opaque on exposure to air; 
slowly soluble in water  
Identification  
Melting range  Between 171 °C and 175 °C with decomposition  
Purity  
Peroxides  No colour develops with added KI-solution  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 290 CARBON DIOXIDE 
Synonyms  Carbonic acid gas; Dry ice (solid form); Carbonic anhydride  
Definition  
Einecs  204-696-9  
Chemical name  Carbon dioxide  
Chemical formula  CO  2 
Molecular weight  44,01  
Assay  Content not less than 99 % v/v on the gaseous basis  
Description  A colourless gas under normal environmental conditions with a 
slight pungent odour. Commercial carbon dioxide is shipped and 
handled as a liquid in pressurised cylinders or bulk storage 
systems, or in compressed solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders
 
Identification  
Precipitate formation  When a stream of the sample is passed through a solution of barium 
hydroxide, a white precipitate is produced which dissolves with 
effervescence in dilute acetic acid  
Purity  
Acidity  915 ml of gas bubbled through 50 ml of freshly boiled water must 
not render the latter more acid to methylorange than is 50 ml freshly 
boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 83
 
Reducing substances, hydrogen 
phosphide and sulphide  915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate 
reagent to which has been added 3 ml of ammonia must not cause 
clouding or blackening of this solution  
Carbon monoxide  Not more than 10 μl/l 
Oil content  Not more than 5 mg/kg  
E 296 MALIC ACID 
Synonyms  Pomalous acid  
Definition  
Einecs  230-022-8, 210-514-9, 202-601-5  
Chemical name  hydroxybutanedioic acid; hydroxysuccinic acid  
Chemical formula  C  4 H 6 O 5 
Molecular weight  134,09  
Assay  Content not less than 99,0 %  
Description  White or nearly white crystalline powder or granules  
Identification  
Melting range  127-132 °C  
Test for malate  Passes test  
Purity  
Sulphated ash  Not more than 0,1 %  
Fumaric acid  Not more than 1,0 %  
Maleic acid  Not more than 0,05 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 297 FUMARIC ACID 
Synonyms  
Definition  
Einecs  203-743-0  
Chemical name  trans -Butenedioic acid;  trans -1,2-Ethylene-dicarboxylic acid  
Chemical formula  C  4 H 4 O 4 
Molecular weight  116,07  
Assay  Content not less than 99,0 % on the anhydrous basis  
Description  White crystalline powder or granules  
Identification  
Melting range  286-302 °C (closed capillary, rapid heating)  
Test for double bonds  Passes test  
Test for 1,2-dicarboxylic acid  Passes test  
pH 3,0-3,2 (0,05 % solution at 25 °C)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 84
 
Purity  
Loss on drying  Not more than 0,5 % (120 °C, 4 hours)  
Sulphated ash  Not more than 0,1 %  
Maleic acid  Not more than 0,1 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 300 ASCORBIC ACID, L-ASCORBIC ACID 
Synonyms  L-xylo-Ascorbic acid; L(+)- Ascorbic acid  
Definition  
Einecs  200-066-2  
Chemical name  L-ascorbic acid; Ascorbic acid; 2,3-Didehydro-L-threo-hexono-1,4- 
lactone; 3-Keto-L-gulofuranolactone  
Chemical formula  C  6 H 8 O 6 
Molecular weight  176,13  
Assay  contains not less than 99 % of C  6 H 8 O 6 after drying in a vacuum 
desiccator over sulphuric acid for 24 hours,  
Description  White to pale yellow, odourless crystalline powder  
Melting range  Between 189 °C and 193 °C with decomposition  
Identification  
Test for ascorbic acid  Passes test  
pH Between 2,4 and 2,8 (2 % aqueous solution)  
Specific rotation  [ α] D 20 between + 20,5° and + 21,5° (10 % w/v aqueous solution)  
Purity  
Loss on drying  Not more than 0,4 % (in vacuum over sulphuric acid, 24 hours)  
Sulphated ash  Not more than 0,1 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 301 SODIUM ASCORBATE 
Synonyms  Sodium L-ascorbate; L-Ascorbic acid monosodium salt  
Definition  
Einecs  205-126-1  
Chemical name  Sodium ascorbate; Sodium L-ascorbate; 2,3-Didehydro-L-threo- 
hexono-1,4-lactone sodium enolate; 3-Keto-L-gulofurano-lactone 
sodium enolate  
Chemical formula  C  6 H 7 O 6 Na ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 85
 
Molecular weight  198,11  
Assay  Sodium ascorbate, after drying in a vacuum desiccator over sulphuric 
acid for 24 hours, contains not less than 99 % of C  6 H 7 O 6 Na 
Description  White or almost white, odourless crystalline powder which darkens 
on exposure to light  
Identification  
Test for ascorbate  Passes test  
Test for sodium  Passes test  
pH Between 6,5 and 8,0 (10 % aqueous solution)  
Specific rotation  [ α] D 20 between + 103° and + 106° (10 % w/v aqueous solution)  
Purity  
Loss on drying  Not more than 0,25 % (in vacuum over sulphuric acid, 24 hours)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 302 CALCIUM ASCORBATE 
Synonyms  Calcium ascorbate dihydrate  
Definition  
Einecs  227-261-5  
Chemical name  Calcium ascorbate dihydrate; Calcium salt of 2,3-didehydro-L-threo- 
hexono-1,4-lactone dihydrate  
Chemical formula  C  12 H 14 O 12 Ca·2H 2 O 
Molecular weight  426,35  
Assay  Content not less than 98 % on a volatile matter-free basis  
Description  White to slightly pale greyish-yellow odourless crystalline powder  
Identification  
Test for ascorbate  Passes test  
Test for calcium  Passes test  
pH Between 6,0 and 7,5 (10 % aqueous solution)  
Specific rotation  [ α] D 20 between + 95° and + 97° (5 % w/v aqueous solution)  
Purity  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Volatile matter  Not more than 0,3 % determined by drying at room temperature for 
24 hours in a desiccator containing sulphuric acid or phosphorus 
pentoxide  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 86
 
E 304 (i) ASCORBYL PALMITATE 
Synonyms  L-ascorbyl palmitate  
Definition  
Einecs  205-305-4  
Chemical name  Ascorbyl palmitate; L-ascorbyl palmitate; 2,3-didehydro-L-threo- 
hexono-1,4-lactone-6-palmitate; 6-palmitoyl-3-keto-L-gulofuranol ­
actone  
Chemical formula  C  22 H 38 O 7 
Molecular weight  414,55  
Assay  Content not less than 98 % on the dried basis  
Description  White or yellowish-white powder with a citrus-like odour  
Identification  
Melting range  Between 107 °C and 117 °C  
Specific rotation  [ α] D 20 between + 21° and + 24° (5 % w/v in methanol solution)  
Purity  
Loss on drying  Not more than 2,0 % (vacuum oven, 56-60 °C, 1 hour)  
Sulphated ash  Not more than 0,1 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 304 (ii) ASCORBYL STEARATE 
Synonyms  
Definition  
Einecs  246-944-9  
Chemical name  Ascorbyl stearate; L-ascorbyl stearate; 2,3-didehydro-L-threo- 
hexono-1,4-lactone-6-stearate; 6-stearoyl-3-keto-L-gulofuranolactone  
Chemical formula  C  24 H 42 O 7 
Molecular weight  442,6  
Assay  Content not less than 98 %  
Description  White or yellowish, white powder with a citrus-like odour  
Identification  
Melting point  About 116 °C  
Purity  
Loss on drying  Not more than 2,0 % (vacuum oven, 56-60 °C, 1 hour)  
Sulphated ash  Not more than 0,1 %  
Arsenic  Not more than 3 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 87
 
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 306 TOCOPHEROL-RICH EXTRACT 
Synonyms  
Definition  Product obtained by the vacuum steam distillation of edible 
vegetable oil products, comprising concentrated tocopherols and tocotrienols 
Contains tocopherols such as d- α-, d-β-, d-γ- and d-δ-tocopherols
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  430,71 (d- α-tocopherol)  
Assay  Content not less than 34 % of total tocopherols  
Description  Brownish red to red, clear, viscous oil having a mild, characteristic 
odour and taste. May show a slight separation of wax-like consti ­
tuents in microcrystalline form  
Identification  
By suitable gas liquid chromatographic 
method  
Specific rotation  [ α] D 20 not less than + 20°  
Solubility  Insoluble in water. Soluble in ethanol. Miscible in ether  
Purity  
Sulphated ash  Not more than 0,1 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 307 ALPHA-TOCOPHEROL 
Synonyms  dl- α-Tocopherol; (all rac)- α-Tocopherol  
Definition  
Einecs  233-466-0  
Chemical name  DL-5,7,8-Trimethyltocol; DL-2,5,7,8-tetramethyl-2-(4 ′,8′,12′- 
trimethyltridecyl)-6-chromanol  
Chemical formula  C  29 H 50 O 2 
Molecular weight  430,71  
Assay  Content not less than 96 %  
Description  Slightly yellow to amber, nearly odourless, clear, viscous oil which 
oxidises and darkens on exposure to air or light  
Identification  
Solubility  Insoluble in water, freely soluble in ethanol, miscible in ether  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 88
 
Spectrophotometry  In absolute ethanol the maximum absorption is about 292 nm  
Specific rotation  [ α] D 25 0° ± 0,05° (1 in 10 solution in chloroform)  
Purity  
Refractive index  [n]  D 20 1,503-1,507  
Specific absorption in ethanol  E  1% 
1cm (292 nm) 71-76 
(0,01 g in 200 ml of absolute ethanol)  
Sulphated ash  Not more than 0,1 %  
Lead  Not more than 2 mg/kg  
E 308 GAMMA-TOCOPHEROL 
Synonyms  dl- γ-Tocopherol  
Definition  
Einecs  231-523-4  
Chemical name  2,7,8-trimethyl-2-(4 ′,8′,12′-trimethyltridecyl)-6-chromanol  
Chemical formula  C  28 H 48 O 2 
Molecular weight  416,69  
Assay  Content not less than 97 %  
Description  Clear, viscous, pale yellow oil which oxidises and darkens on 
exposure to air or light  
Identification  
Spectrometry  Maximum absorptions in absolute ethanol at about 298 nm and 
257 nm  
Purity  
Specific absorption in ethanol  E  1% 
1cm (298 nm) between 91 and 97  
E 1% 
1cm (257 nm) between 5,0 and 8,0  
Refractive index  [n]  D 20 1,503-1,507  
Sulphated ash  Not more than 0,1 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 309 DELTA-TOCOPHEROL 
Synonyms  
Definition  
Einecs  204-299-0  
Chemical name  2,8-dimethyl-2-(4 ′,8′,12′-trimethyltridecyl)-6-chromanol  
Chemical formula  C  27 H 46 O 2 
Molecular weight  402,7  
Assay  Content not less than 97 %  
Description  Clear, viscous, pale yellowish or orange oil which oxidises and 
darkens on exposure to air or light  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 89
 
Identification  
Spectrometry  Maximum absorptions in absolute ethanol at about 298 nm and 
257 nm  
Purity  
Specific absorption  E 1% 
1cm in ethanol  E  1% 
1cm (298 nm) between 89 and 95  
E 1% 
1cm (257 nm) between 3,0 and 6,0  
Refractive index  [n]  D 20 1,500-1,504  
Sulphated ash  Not more than 0,1 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 310 PROPYL GALLATE 
Synonyms  
Definition  
Einecs  204-498-2  
Chemical name  Propyl gallate; Propyl ester of gallic acid; n-propyl ester of 3,4,5- 
trihydroxybenzoic acid  
Chemical formula  C  10 H 12 O 5 
Molecular weight  212,20  
Assay  Content not less than 98 % on the anhydrous basis  
Description  White to creamy-white, crystalline, odourless solid  
Identification  
Solubility  Slightly soluble in water, freely soluble in ethanol, ether and 
propane-1,2-diol  
Melting range  Between 146 °C and 150 °C after drying at 110 °C for four hours  
Purity  
Loss on drying  Not more than 0,5% (110 °C, 4 hours)  
Sulphated ash  Not more than 0,1 %  
Free acid  Not more than 0,5 % (as gallic acid)  
Chlorinated organic compound  Not more than 100 mg/kg (as C1)  
Specific absorption in ethanol  E  1% 
1cm (275 nm) not less than 485 and not more than 520  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 311 OCTYL GALLATE 
Synonyms  
Definition  
Einecs  213-853-0  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 90
 
Chemical name  Octyl gallate; Octyl ester of gallic acid; n-octyl ester of 3,4,5-trihy ­
droxybenzoic acid  
Chemical formula  C  15 H 22 O 5 
Molecular weight  282,34  
Assay  Content not less than 98 % after drying at 90 °C for six hours  
Description  White to creamy-white odourless solid  
Identification  
Solubility  Insoluble in water, freely soluble in ethanol, ether and propane-1,2- 
diol 
Melting range  Between 99 °C and 102 °C after drying at 90 °C for six hours  
Purity  
Loss on drying  Not more than 0,5 % (90 °C, 6 hours)  
Sulphated ash  Not more than 0,05 %  
Free acid  Not more than 0,5 % (as gallic acid)  
Chlorinated organic compound  Not more than 100 mg/kg (as C1)  
Specific absorption in ethanol  E  1% 
1cm (275 nm) not less than 375 and not more than 390  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 312 DODECYL GALLATE 
Synonyms  Lauryl gallate  
Definition  
Einecs  214-620-6  
Chemical name  Dodecyl gallate; n-dodecyl (or lauryl) ester of 3,4,5-trihydroxy ­
benzoic acid; Dodecyl ester of gallic acid  
Chemical formula  C  19 H 30 O 5 
Molecular weight  338,45  
Assay  Content not less than 98 % after drying at 90 °C for six hours  
Description  White or creamy-white odourless solid  
Identification  
Solubility  Insoluble in water, freely soluble in ethanol and ether  
Melting range  Between 95 °C and 98 °C after drying at 90 °C for six hours  
Purity  
Loss on drying  Not more than 0,5 % (90 °C, 6 hours)  
Sulphated ash  Not more than 0,05 %  
Free acid  Not more than 0,5 % (as gallic acid)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 91
 
Chlorinated organic compound  Not more than 100 mg/kg (as Cl)  
Specific absorption in ethanol  E  1% 
1cm (275 nm) not less than 300 and not more than 325  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 315 ERYTHORBIC ACID 
Synonyms  Isoascorbic acid; D-Araboascorbic acid  
Definition  
Einecs  201-928-0  
Chemical name  D-Erythro-hex-2-enoic acid γ-lactone; Isoascorbic acid; D-Isoas ­
corbic acid  
Chemical formula  C  6 H 8 O 6 
Molecular weight  176,13  
Assay  Content not less than 98 % on the anhydrous basis  
Description  White to slightly yellow crystalline solid which darkens gradually on 
exposure to light  
Identification  
Melting range  About 164 °C to 172 °C with decomposition  
Test for ascorbic acid/colour reaction  Passes test  
Specific rotation  [ α] D 25 10 % (w/v) aqueous solution between – 16,5° to – 18,0°  
Purity  
Loss on drying  Not more than 0,4 % after drying under (reduced pressure on silica 
gel, 3 hours)  
Sulphated ash  Not more than 0,3 %  
Oxalate  To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic 
acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear
 
Lead  Not more than 2 mg/kg  
E 316 SODIUM ERYTHORBATE 
Synonyms  Sodium isoascorbate  
Definition  
Einecs  228-973-9  
Chemical name  Sodium isoascorbate; Sodium D-isoascorbic acid; Sodium salt of 
2,3-didehydro-D-erythro-hexono-1,4-lactone; 3-keto-D-gulofurano- lactone sodium enolate monohydrate
 
Chemical formula  C  6 H 7 O 6 Na·H 2 O 
Molecular weight  216,13  
Assay  Content not less than 98 % after drying in a vacuum desiccator over 
sulphuric acid for 24 hours expressed on the monohydrate basis  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 92
 
Description  White crystalline solid  
Identification  
Solubility  Freely soluble in water, very slightly soluble in ethanol  
Test for ascorbic acid/colour reaction  Passes test  
Test for sodium  Passes test  
pH 5,5 to 8,0 (10 % aqueous solution)  
Specific rotation  [ α] D 25 10 % (w/v) aqueous solution between + 95° and + 98°  
Purity  
Loss on drying  Not more than 0,25 % after drying (in vacuum over sulphuric acid, 
24 hours)  
Oxalate  To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic 
acid and 5 ml of 10 % calcium acetate solution. The solution should 
remain clear.  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ) 
Synonyms  TBHQ  
Definition  
Einecs  217-752-2  
Chemical name  Tert-butyl-1,4-benzenediol; 2-(1,1-Dimethylethyl)-1,4-benzenediol  
Chemical formula  C  10 H 14 O 2 
Molecular weight  166,22  
Assay  Content not less than 99 % of C  10 H 14 O 2 
Description  White crystalline solid having a characteristic odour  
Identification  
Solubility  Practically insoluble in water; soluble in ethanol  
Melting point  Not less than 126,5 °C  
Phenolics  Dissolve about 5 mg of the sample in 10 ml of methanol and add 
10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is 
produced  
Purity  
Tertiary-Butyl- p-benzoquinone  Not more than 0,2 %  
2,5-Di-tertiary-butyl hydroquinone  Not more than 0,2 %  
Hydroxyquinone  Not more than 0,1 %  
Toluene  Not more than 25 mg/kg  
Lead  Not more than 2 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 93
 
E 320 BUTYLATED HYDROXYANISOLE (BHA) 
Synonyms  BHA  
Definition  
Einecs  246-563-8  
Chemical name  3-Tertiary-butyl-4-hydroxyanisole; A mixture of 2-tertiary-butyl-4- 
hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole  
Chemical formula  C  11 H 16 O 2 
Molecular weight  180,25  
Assay  Content not less than 98,5 % of C  11 H 16 O 2 and not less than 85 % of 
3-tertiary-butyl-4-hydroxyanisole isomer  
Description  White or slightly yellow flakes or waxy solid with a slight aromatic 
smell  
Identification  
Solubility  Insoluble in water, freely soluble in ethanol  
Melting range  Between 48 °C and 63 °C  
Colour reaction  Passes test for phenol groups  
Purity  
Sulphated ash  Not more than 0,05 % after calcination at 800 ± 25 °C  
Phenolic impurities  Not more than 0,5 %  
Specific absorption  E  1% 
1cm (290 nm) not less than 190 and not more than 210  
E 1% 
1cm (228 nm) not less than 326 and not more than 345  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 321 BUTYLATED HYDROXYTOLUENE (BHT) 
Synonyms  BHT  
Definition  
Einecs  204-881-4  
Chemical name  2,6-Ditertiary-butyl- p-cresol; 4-Methyl-2,6-ditertiarybutylphenol  
Chemical formula  C  15 H 24 O 
Molecular weight  220,36  
Assay  Content not less than 99 %  
Description  White, crystalline or flaked solid, odourless or having a characteristic 
faint aromatic odour  
Identification  
Solubility  Insoluble in water and propane- 1,2-diol 
Freely soluble in ethanol  
Melting point  At 70 °C  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 94
 
Spectrometry  The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 
100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm
 
Purity  
Sulphated ash  Not more than 0,005 %  
Phenolic impurities  Not more than 0,5 %  
Specific absorption in ethanol  E  1% 
1cm (278 nm) not less than 81 and not more than 88  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 322 LECITHINS 
Synonyms  Phosphatides; Phospholipids  
Definition  Lecithins are mixtures or fractions of phosphatides obtained by 
physical procedures from animal or vegetable foodstuffs; they also 
include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity 
The lecithins may be slightly bleached in aqueous medium by means 
of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides
 
Einecs  232-307-2  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Lecithins: not less than 60,0 % of substances insoluble in acetone 
Hydrolysed lecithins: not less than 56,0 % of substances insoluble in 
acetone  
Description  Lecithins: brown liquid or viscous semi-liquid or powder 
Hydrolysed lecithins: light brown to brown viscous liquid or paste  
Identification  
Test for choline  Passes test  
Test for phosphorus  Passes test  
Test for fatty acids  Passes test  
Test for hydrolysed lecithin  To a 800 ml beaker add 500 ml of water (30-35 °C). Then slowly 
add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will 
form a distinct mass of about 50 g
 
Purity  
Loss on drying  Not more than 2,0 % (105 °C, 1 hour)  
Toluene-insoluble matter  Not more than 0,3 %  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 95
 
Acid value  Lecithins: not more than 35 mg of potassium hydroxide per gram 
Hydrolysed lecithins: not more than 45 mg of potassium hydroxide 
per gram  
Peroxide value  Equal to or less than 10  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 325 SODIUM LACTATE 
Synonyms  
Definition  
Einecs  200-772-0  
Chemical name  Sodium lactate; Sodium 2-hydroxypropanoate  
Chemical formula  C  3 H 5 NaO  3 
Molecular weight  112,06 (anhydrous)  
Assay  Content not less than 57 % and not more than 66 %  
Description  Colourless, transparent, liquid. Odourless, or with a slight, char ­
acteristic odour  
Identification  
Test for lactate  Passes test  
▼M3 
Test for sodium  Passes test  
▼B 
pH 6,5 to 7,5 (20 % aqueous solution)  
Purity  
Acidity  Not more than 0,5 % after drying expressed as lactic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Reducing substances  No reduction of Fehling's solution  
Note:  This specification refers to a 60 % aqueous solution  
E 326 POTASSIUM LACTATE 
Synonyms  
Definition  
Einecs  213-631-3  
Cheminal name  Potassium lactate; Potassium 2-hydroxypropanoate  
Chemical formula  C  3 H 5 O 3 K 
Molecular weight  128,17 (anhydrous)  
Assay  Content not less than 57 % and not more than 66 %  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 96
 
Description  Slightly viscous, almost odourless clear liquid. Odourless, or with a 
slight, characteristic odour  
Identification  
Ignition  Ignite potassium lactate solution to an ash. The ash is alkaline, and 
an effervescence occurs when acid is added  
Colour reaction  Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 
solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact
 
Test for potassium  Passes test  
Test for lactate  Passes test  
Purity  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Acidity  Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 
drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required
 
Reducing substances  No reduction of Fehling's solution  
Note:  This specification refers to a 60 % aqueous solution  
E 327 CALCIUM LACTATE 
Synonyms  
Definition  
Einecs  212-406-7  
Chemical name  Calcium dilactate; Calcium dilactate hydrate; 2-Hydroxypropanoic 
acid calcium salt  
Chemical formula  (C  3 H 5 O 2 ) 2 Ca·nH 2 O (n = 0 - 5)  
Molecular weight  218,22 (anhydrous)  
Assay  Content not less than 98 % on the anhydrous basis  
Description  Almost odourless, white crystalline powder or granules  
Identification  
Test for lactate  Passes test  
Test for calcium  Passes test  
Solubility  Soluble in water and practically insoluble in ethanol  
pH Between 6,0 and 8,0 (5 % solution)  
Purity  
Loss on drying  anhydrous: not more than 3,0 % (120 °C, 4 hours) 
with 1 molecule of water: not more than 8,0 % (120 °C, 4 hours) 
with 3 molecules of water: not more than 20,0 % (120 °C, 4 hours) 
with 4,5 molecules of water: not more than 27,0 % (120 °C, 4 
hours)  
Acidity  Not more than 0,5 % of the dry matter expressed as lactic acid  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 97
 
Fluoride  Not more than 30 mg/kg (expressed as fluorine)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Reducing substances  No reduction of Fehling's solution  
E 330 CITRIC ACID 
Synonyms  
Definition  Citric acid is produced from lemon or pineapple juice, by fermen ­
tation of carbohydrate solutions or other suitable media using  
Candida  spp. or non-toxicogenic strains of  Aspergillus niger  
Einecs  201-069-1  
Chemical name  Citric acid; 2-Hydroxy-1,2,3-propanetricarboxylic acid; β-Hydroxy ­
tricarballylic acid  
Chemical formula  (a) C  6 H 8 O 7 (anhydrous) 
(b) C  6 H 8 O 7 ·H2O (monohydrate)  
Molecular weight  (a) 192,13 (anhydrous) 
(b) 210,15 (monohydrate)  
Assay  Citric acid may be anhydrous or it may contain 1 molecule of water. 
Citric acid contains not less than 99,5 % of C  6 H 8 O 7 , calculated on 
the anhydrous basis  
Description  Citric acid is a white or colourless, odourless, crystalline solid, 
having a strongly acid taste. The monohydrate effloresces in dry air  
Identification  
Solubility  Very soluble in water; freely soluble in ethanol; soluble in ether  
Purity  
Water content  Anhydrous citric acid contains not more than 0,5 % water; citric acid 
monohydrate contains not more than 8,8 % water (Karl Fischer method)
 
Sulphated ash  Not more than 0,05 % after calcination at 800 ± 25 °C  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 0,5 mg/kg  
Mercury  Not more than 1 mg/kg  
Oxalates  Not more than 100 mg/kg, expressed as oxalic acid, after drying  
Readily carbonisable substances  Heat 1 g of powdered sample with 10 ml of 98 % minimum 
sulphuric acid in a water bath at 90 °C in the dark for one hour. Not more than a pale brown colour should be produced (Matching 
Fluid K)
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 98
 
E 331 (i) MONOSODIUM CITRATE 
Synonyms  Monobasic sodium citrate  
Definition  
Einecs  242-734-6  
Chemical name  Monosodium citrate; Monosodium salt of 2-hydroxy-1,2,3-propane ­
tricarboxylic acid  
Chemical formula  (a) C  6 H 7 O 7 Na (anhydrous) 
(b) C  6 H 7 O 7 Na·H 2 O (monohydrate)  
Molecular weight  (a) 214,11 (anhydrous) 
(b) 232,23 (monohydrate)  
Assay  Content not less than 99 % on the anhydrous basis  
Description  Crystalline white powder or colourless crystals  
Identification  
Test for citrate  Passes test  
Test for sodium  Passes test  
pH Between 3,5 and 3,8 (1 % aqueous solution)  
Purity  
Loss on drying  anhydrous: not more than 1,0 % (140 °C, 0,5 hour) 
monohydrate: not more than 8,8 % (180 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg expressed as oxalic acid, after drying  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 331 (ii) DISODIUM CITRATE 
Synonyms  Dibasic sodium citrate  
Definition  
Einecs  205-623-3  
Chemical name  Disodium citrate; Disodium salt of 2-hydroxy-1,2,3-propanetricar ­
boxylic acid; Disodium salt of citric acid with 1,5 molecules of 
water  
Chemical formula  C  6 H 6 O 7 Na 2 ·1,5H  2 O 
Molecular weight  263,11  
Assay  Content not less than 99 % on the anhydrous basis  
Description  Crystalline white powder or colourless crystals  
Identification  
Test for citrate  Passes test  
Test for sodium  Passes test  
pH Between 4,9 and 5,2 (1 % aqueous solution)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 99
 
Purity  
Loss on drying  Not more than 13,0 % (180 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg expressed as oxalic acid, after drying  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 331 (iii) TRISODIUM CITRATE 
Synonyms  Tribasic sodium citrate  
Definition  
Einecs  200-675-3  
Chemical name  Trisodium citrate; Trisodium salt of 2-hydroxy-1,2,3-propanetricar ­
boxylic acid; Trisodium salt of citric acid, in anhydrous, dihydrate or 
pentahydrate form  
Chemical formula  Anhydrous: C  6 H 5 O 7 Na 3 
Hydrated: C  6 H 5 O 7 Na 3 ·nH 2 O (n = 2 or 5)  
Molecular weight  258,07 (anhydrous) 
294,10 (hydrated n = 2) 
348,16 (hydrated n = 5)  
Assay  Not less than 99 % on the anhydrous basis  
Description  Crystalline white powder or colourless crystals  
Identification  
Test for citrate  Passes test  
Test for sodium  Passes test  
pH Between 7,5 and 9,0 (5 % aqueous solution)  
Purity  
Loss of drying  Anhydrous: not more than 1,0 % (180 °C, 18 hours) 
Dihydrate: 10,0 to 13,0 % (180 °C, 18 hours) 
Pentahydrate: not more than 30,3 % (180 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg expressed as oxalic acid, after drying  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 332 (i) MONOPOTASSIUM CITRATE 
Synonyms  Monobasic potassium citrate  
Definition  
Einecs  212-753-4  
Chemical name  Monopotassium citrate; Monopotassium salt of 2-hydroxy-1,2,3- 
propanetricarboxylic acid; Anhydrous monopotassium salt of citric acid
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 100
 
Chemical formula  C  6 H 7 O 7 K 
Molecular weight  230,21  
Assay  Content not less than 99 % on the anhydrous basis  
Description  White, hygroscopic, granular powder or transparent crystals  
Identification  
Test for citrate  Passes test  
Test for potassium  Passes test  
pH Between 3,5 and 3,8 (1 % aqueous solution)  
Purity  
Loss on drying  Not more than 1,0 % (180 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg expressed as oxalic acid, after drying  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 332 (ii) TRIPOTASSIUM CITRATE 
Synonyms  Tribasic potassium citrate  
Definition  
Einecs  212-755-5  
Chemical name  Tripotassium citrate; Tripotassium salt of 2-hydroxy-1,2,3-propane ­
tricarboxylic acid; Monohydrated tripotassium salt of citric acid  
Chemical formula  C  6 H 5 O 7 K 3 ·H 2 O 
Molecular weight  324,42  
Assay  Content not less than 99 % on the anhydrous basis  
Description  White, hygroscopic, granular powder or transparent crystals  
Identification  
Test for citrate  Passes test  
Test for potassium  Passes test  
pH Between 7,5 and 9,0 (5 % aqueous solution)  
Purity  
Loss on drying  Not more than 6,0 % (180 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg (expressed as oxalic acid, after drying)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 101
 
E 333 (i) MONOCALCIUM CITRATE 
Synonyms  Monobasic calcium citrate  
Definition  
Einecs  
Chemical name  Monocalcium citrate; Monocalcium salt of 2-hydroxy-1,2,3-propane ­
tricarboxylic acid; Monohydrate monocalcium salt of citric acid  
Chemical formula  (C  6 H 7 O 7 ) 2 Ca·H 2 O 
Molecular weight  440,32  
Assay  Content not less than 97,5 % on the anhydrous basis  
Description  Fine white powder  
Identification  
Test for citrate  Passes test  
Test for calcium  Passes test  
pH Between 3,2 and 3,5 (1 % aqueous solution)  
Purity  
Loss on drying  Not more than 7,0 % (180 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg (expressed as oxalic acid, after drying)  
Fluoride  Not more than 30 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Aluminium  Not more than 30 mg/kg (only if added to food for infants and 
young children) 
Not more than 200 mg/kg (for all uses except food for infants and 
young children)  
Carbonates  Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid 
must not liberate more than a few isolated bubbles  
E 333 (ii) DICALCIUM CITRATE 
Synonyms  Dibasic calcium citrate  
Definition  
Einecs  
Chemical name  Dicalcium citrate; Dicalcium salt of 2-hydroxy-1,2,3-propanetricar ­
boxylic acid; Trihydrated dicalcium salt of citric acid  
Chemical formula  (C  6 H 7 O 7 ) 2 Ca 2 ·3H 2 O 
Molecular weight  530,42  
Assay  Not less than 97,5 % on the anhydrous basis  
Description  Fine white powder  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 102
 
Identification  
Test for citrate  Passes test  
Test for calcium  Passes test  
Purity  
Loss on drying  Not more than 20,0 % (180 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg (expressed as oxalic acid, after drying)  
Fluoride  Not more than 30 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Aluminium  Not more than 30 mg/kg (only if added to food for infants and 
young children) 
Not more than 200 mg/kg (for all uses except food for infants and 
young children)  
Carbonates  Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid 
must not liberate more than a few isolated bubbles  
E 333 (iii) TRICALCIUM CITRATE 
Synonyms  Tribasic calcium citrate  
Definition  
Einecs  212-391-7  
Chemical name  Tricalcium citrate; Tricalcium salt of 2-hydroxy-1,2,3-propanetricar ­
boxylic acid; Tetrahydrated tricalcium salt of citric acid  
Chemical formula  (C  6 H 6 O 7 ) 2 Ca 3 ·4H 2 O 
Molecular weight  570,51  
Assay  Not less than 97,5 % on the anhydrous basis  
Description  Fine white powder  
Identification  
Test for citrate  Passes test  
Test for calcium  Passes test  
Purity  
Loss on drying  Not more than 14,0 % (180 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg (expressed as oxalic acid, after drying)  
Fluoride  Not more than 30 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 103
 
Aluminium  Not more than 30 mg/kg (only if added to food for infants and 
young children) 
Not more than 200 mg/kg (for all uses except food for infants and 
young children)  
Carbonates  Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid 
must not liberate more than a few isolated bubbles  
E 334 L(+)-TARTARIC ACID, TARTARIC ACID 
Synonyms  
Definition  
Einecs  201-766-0  
Chemical name  L-tartaric acid; L-2,3-dihydroxybutanedioic acid; d- α,β-dihydroxy ­
succinic acid  
Chemical formula  C  4 H 6 O 6 
Molecular weight  150,09  
Assay  Content not less than 99,5 % on the anhydrous basis  
Description  Colourless or translucent crystalline solid or white crystalline powder  
Identification  
Melting range  Between 168 °C and 170 °C  
Test for tartrate  Passes test  
Specific rotation  [ α] D 20 between + 11,5° and + 13,5° (20 % w/v aqueous solution)  
Purity  
Loss on drying  Not more than 0,5 % (over P  2 O 5 , 3 hours)  
Sulphated ash  Not more than 1 000 mg/kg (after calcination at 800 ± 25 °C)  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Oxalates  Not more than 100 mg/kg expressed as oxalic acid, after drying  
E 335 (i) MONOSODIUM TARTRATE 
Synonyms  Monosodium salt of L-(+)-tartaric acid  
Definition  
Einecs  
Chemical name  Monosodium salt of L-2,3-dihydroxybutanedioic acid; Monohy ­
drated monosodium salt of L-(+)-tartaric acid  
Chemical formula  C  4 H 5 O 6 Na·H 2 O 
Molecular weight  194,05  
Assay  Content not less than 99 % on the anhydrous basis  
Description  Transparent colourless crystals  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 104
 
Identification  
Test for tartrate  Passes test  
Test for sodium  Passes test  
Purity  
Loss on drying  Not more than 10,0 % (105 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg (expressed as oxalic acid, after drying)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 335 (ii) DISODIUM TARTRATE 
Synonyms  
Definition  
Einecs  212-773-3  
Chemical name  Disodium L-tartrate; Disodium (+)-tartrate; Disodium salt of (+)-2,3- 
dihydroxybutanedioic acid; Dihydrated disodium salt of L- 
(+)-tartaric acid  
Chemical formula  C  4 H 4 O 6 Na 2 ·2H 2 O 
Molecular weight  230,8  
Assay  Content not less than 99 % on the anhydrous basis  
Description  Transparent, colourless crystals  
Identification  
Test for tartrate  Passes test  
Test for sodium  Passes test  
Solubility  1 gram is insoluble in 3 ml of water. Insoluble in ethanol  
pH Between 7,0 and 7,5 (1 % aqueous solution)  
Purity  
Loss on drying  Not more than 17,0 % (150 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg (expressed as oxalic acid, after drying)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 336 (i) MONOPOTASSIUM TARTRATE 
Synonyms  Monobasic potassium tartrate  
Definition  
Einecs  
Chemical name  Anhydrous monopotassium salt of L-(+)-tartaric acid; Monopot ­
assium salt of L-2,3-dihydroxybutanedioic acid  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 105
 
Chemical formula  C  4 H 5 O 6 K 
Molecular weight  188,16  
Assay  Content not less than 98 % on the anhydrous basis  
Description  White crystalline or granulated powder  
Identification  
Test for tartrate  Passes test  
Test for potassium  Passes test  
Melting point  230 °C  
pH 3,4 (1 % aqueous solution)  
Purity  
Loss on drying  Not more than 1,0 % (105 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg (expressed as oxalic acid, after drying)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 336 (ii) DIPOTASSIUM TARTRATE 
Synonyms  Dibasic potassium tartrate  
Definition  
Einecs  213-067-8  
Chemical name  Dipotassium salt of L-2,3-dihydroxybutanedioic acid; Dipotassium 
salt with half a molecule of water of L-(+)-tartaric acid  
Chemical formula  C  4 H 4 O 6 K 2 ·½H  2 O 
Molecular weight  235,2  
Assay  Content not less than 99 % on the anhydrous basis  
Description  White crystalline or granulated powder  
Identification  
Test for tartrate  Passes test  
Test for potassium  Passes test  
pH Between 7,0 and 9,0 (1 % aqueous solution)  
Purity  
Loss on drying  Not more than 4,0 % (150 °C, 4 hours)  
Oxalates  Not more than 100 mg/kg (expressed as oxalic acid, after drying)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 106
 
E 337 POTASSIUM SODIUM TARTRATE 
Synonyms  Potassium sodium L-(+)-tartrate; Rochelle salt; Seignette salt  
Definition  
Einecs  206-156-8  
Chemical name  Potassium sodium salt of L-2,3-dihydroxybutanedioic acid; 
Potassium sodium L-(+)-tartrate  
Chemical formula  C  4 H 4 O 6 KNa·4H 2 O 
Molecular weight  282,23  
Assay  Content not less than 99 % on the anhydrous basis  
Description  Colourless crystals or white crystalline powder  
Identification  
Test for tartrate  Passes test  
Test for potassium  Passes test  
Test for sodium  Passes test  
Solubility  1 gram is soluble in 1 ml of water, insoluble in ethanol  
Melting range  70-80 °C  
pH Between 6,5 and 8,5 (1 % aqueous solution)  
Purity  
Loss on drying  Not more than 26,0 % and not less than 21,0 % (150 °C, 3 hours)  
Oxalates  Not more than 100 mg/kg (expressed as oxalic acid, after drying)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 338 PHOSPHORIC ACID 
Synonyms  Orthophosphoric acid; Monophosphoric acid  
Definition  
Einecs  231-633-2  
Chemical name  Phosphoric acid  
Chemical formula  H  3 PO 4 
Molecular weight  98,00  
Assay  Content not less than 67,0 % and not more than 85,7 %. Phosphoric 
acid is commercially available as an aqueous solution at variable concentrations.
 
Description  Clear, colourless, viscous liquid  
Identification  
Test for acid  Passes test  
Test for phosphate  Passes test  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 107
 
Purity  
Volatile acids  Not more than 10 mg/kg (as acetic acid)  
Chlorides  Not more than 200 mg/kg (expressed as chlorine)  
Nitrates  Not more than 5 mg/kg (as NaNO  3 ) 
Sulphates  Not more than 1 500 mg/kg (as CaSO  4 ) 
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Note:  This specification refers to a 75 % aqueous solution  
E 339 (i) MONOSODIUM PHOSPHATE 
Synonyms  Monosodium monophosphate; Acid monosodium monophosphate; 
Monosodium orthophosphate; Monobasic sodium phosphate; Sodium dihydrogen monophosphate
 
Definition  
Einecs  231-449-2  
Chemical name  Sodium dihydrogen monophosphate  
Chemical formula  Anhydrous: NaH  2 PO 4 
Monohydrate: NaH  2 PO 4 · H 2 O 
Dihydrate: NaH  2 PO 4 · 2H  2 O 
Molecular weight  Anhydrous: 119,98 
Monohydrate: 138,00 
Dihydrate: 156,01  
Assay  After drying at 60 °C for one hour and then at 105 °C for four 
hours, contains not less than 97 % of NaH  2 PO 4 
P 2 O 5 content between 58,0 % and 60,0 % on the anhydrous basis  
Description  A white odourless, slightly deliquescent powder, crystals or granules  
Identification  
Test for sodium  Passes test  
Test for phosphate  Passes test  
Solubility  Freely soluble in water. Insoluble in ethanol or ether  
pH Between 4,1 and 5,0 (1 % solution)  
Purity  
Loss on drying  The anhydrous salt loses not more than 2,0 %, the monohydrate not 
more than 15,0 %, the dihydrate not more than 25 % (60 °C, 1 hour then 105 °C, 4 hours)
 
Water insoluble matter  Not more than 0,2 % on the anhydrous basis  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 108
 
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 339 (ii) DISODIUM PHOSPHATE 
Synonyms  Disodium monophosphate; Secondary sodium phosphate; Disodium 
orthophosphate;  
Definition  
Einecs  231-448-7  
Chemical name  Disodium hydrogen monophosphate; Disodium hydrogen orthophos ­
phate  
Chemical formula  Anhydrous:Na  2 HPO  4 
Hydrate: Na  2 HPO  4 · nH  2 O (n = 2, 7 or 12)  
Molecular weight  141,98 (anhydrous)  
Assay  After drying at 40 °C for three hours and subsequently at 105 °C for 
five hours, contains not less than 98 % of Na  2 HPO  4 
P 2 O 5 content between 49 % and 51 % on the anhydrous basis  
Description  Anhydrous disodium hydrogen phosphate is a white, hygroscopic, 
odourless powder. Hydrated forms available include the dihydrate: a 
white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals
 
Identification  
Test for sodium  Passes test  
Test for phosphate  Passes test  
Solubility  Freely soluble in water. Insoluble in ethanol  
pH Between 8,4 and 9,6 (1 % solution)  
Purity  
Loss on drying  The anhydrous salt loses not more than 5,0 %, the dihydrate not 
more than 22,0 %, the heptahydrate not more than 50,0 %, the 
dodecahydrate not more than 61,0 % (40 °C, 3 hours then 105 °C, 5 hours)
 
Water insoluble matter  Not more than 0,2 % on the anhydrous basis  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 339 (iii) TRISODIUM PHOSPHATE 
Synonyms  Sodium phosphate; Tribasic sodium phosphate; Trisodium ortho ­
phosphate  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 109
 
Definition  Trisodium phosphate is obtained from aqueous solutions and cryst ­
allises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H  2 O. The 
dodecahydrate always crystallises from aqueous solutions with an 
excess of sodium hydroxide. It contains ¼ molecule of NaOH  
Einecs  231-509-8  
Chemical name  Trisodium monophosphate; Trisodium phosphate; Trisodium ortho ­
phosphate  
Chemical formula  Anhydrous: Na  3 PO 4 
Hydrated: Na  3 PO 4 nH 2 O (n = 1/2, 1, 6, 8, or 12)  
Molecular weight  163,94 (anhydrous)  
Assay  Sodium phosphate anhydrous and the hydrated forms, with the 
exception of the dodecahydrate, contain not less than 97,0 % of Na
 3 PO 4 calculated on the dried basis. Sodium phosphate 
dodecahydrate contains not less than 92,0 % of Na  3 PO 4 calculated 
on the ignited basis 
P 2 O 5 content between 40,5 % and 43,5 % on the anhydrous basis  
Description  White odourless crystals, granules or crystalline powder  
Identification  
Test for sodium  Passes test  
Test for phosphate  Passes test  
Solubility  Freely soluble in water. Insoluble in ethanol  
pH Between 11,5 and 12,5 (1 % solution)  
Purity  
Loss on ignition  When dried at 120 °C for two hours and then ignited at about 
800 °C for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 %
 
Water insoluble matter  Not more than 0,2 % on the anhydrous basis  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 340 (i) MONOPOTASSIUM PHOSPHATE 
Synonyms  Monobasic potassium phosphate; Monopotassium monophosphate; 
Mono potassium orthophosphate  
Definition  
Einecs  231-913-4  
Chemical name  Potassium dihydrogen phosphate; Monopotassium dihydrogen ortho ­
phosphate; Monopotassium dihydrogen monophosphate  
Chemical formula  KH  2 PO 4 
Molecular weight  136,09  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 110
 
Assay  Content not less than 98,0 % after drying at 105 °C for four hours 
P 2 O 5 content between 51,0 % and 53,0 % on the anhydrous basis  
Description  Odourless, colourless crystals or white granular or crystalline powder  
Identification  
Test for potassium  Passes test  
Test for phosphate  Passes test  
Solubility  Freely soluble in water. Insoluble in ethanol  
pH Between 4,2 and 4,8 (1 % solution)  
Purity  
Loss on drying  Not more than 2,0 % (105 °C, 4 hours)  
Water insoluble matter  Not more than 0,2 % on the anhydrous basis  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 340 (ii) DIPOTASSIUM PHOSPHATE 
Synonyms  Dipotassium monophosphate; Secondary potassium phosphate; 
Dipotassium orthophosphate; Dibasic potassium phosphate  
Definition  
Einecs  231-834-5  
Chemical name  Dipotassium hydrogen monophosphate; Dipotassium hydrogen phos ­
phate; Dipotassium hydrogen orthophosphate  
Chemical formula  K  2 HPO  4 
Molecular weight  174,18  
Assay  Content not less than 98 % after drying at 105 °C for four hours 
P 2 O 5 content between 40,3 % and 41,5 % on the anhydrous basis  
Description  Colourless or white granular powder, crystals or masses; deli ­
quescent substance, hygroscopic  
Identification  
Test for potassium  Passes test  
Test for phosphate  Passes test  
Solubility  Freely soluble in water. Insoluble in ethanol  
pH Between 8,7 and 9,4 (1 % solution)  
Purity  
Loss on drying  Not more than 2,0 % (105 °C, 4 hours)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 111
 
Water insoluble matter  Not more than 0,2 % (on the anhydrous basis)  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 340 (iii) TRIPOTASSIUM PHOSPHATE 
Synonyms  Tribasic potassium phosphate; Tripotassium orthophosphate  
Definition  
Einecs  231-907-1  
Chemical name  Tripotassium monophosphate; Tripotassium phosphate; Tripotassium 
orthophosphate  
Chemical formula  Anhydrous: K  3 PO 4 
Hydrated: K  3 PO 4 · nH  2 O (n = 1 or 3)  
Molecular weight  212,27 (anhydrous)  
Assay  Content not less than 97 % calculated on the ignited basis 
P 2 O 5 content between 30,5 % and 34,0 % on the ignited basis  
Description  Colourless or white, odourless hygroscopic crystals or granules. 
Hydrated forms available include the monohydrate and trihydrate  
Identification  
Test for potassium  Passes test  
Test for phosphate  Passes test  
Solubility  Freely soluble in water. Insoluble in ethanol  
pH Between 11,5 and 12,3 (1 % solution)  
Purity  
Loss on ignition  Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 % 
(determined by drying at 105 °C for one hour and then ignite at 
about 800 °C ± 25 °C for 30 minutes)  
Water insoluble matter  Not more than 0,2 % (on the anhydrous basis)  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 341 (i) MONOCALCIUM PHOSPHATE 
Synonyms  Monobasic calcium phosphate; Monocalcium orthophosphate  
Definition  
Einecs  231-837-1  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 112
 
Chemical name  Calcium dihydrogen phosphate  
Chemical formula  Anhydrous: Ca(H  2 PO 4 ) 2 
Monohydrate: Ca(H  2 PO 4 ) 2 · H 2 O 
Molecular weight  234,05 (anhydrous) 
252,08 (monohydrate)  
Assay  Content not less than 95 % on the dried basis 
P 2 O 5 content between 55,5 % and 61,1 % on the anhydrous basis  
Description  Granular powder or white, deliquescent crystals or granules  
Identification  
Test for calcium  Passes test  
Test for phosphate  Passes test  
CaO content  Between 23,0 % and 27,5 % (anhydrous) 
Between 19,0 % and 24,8 % (monohydrate)  
Purity  
Loss on drying  Anhydrous: not more than 14 % (105 °C, 4 hours) 
Monohydrate: not more than 17,5 % (105 °C, 4 hours)  
Loss on ignition  Anhydrous: not more than 17,5 % (after ignition at 800 °C ± 25 °C 
for 30 minutes) 
Monohydrate: not more than 25,0 % (determined by drying at 
105 °C for one hour, then ignite at 800 °C ± 25 °C for 30 minutes)  
Fluoride  Not more than 30 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Aluminium  Not more than 70 mg/kg (only if added to food for infants and 
young children) 
Not more than 200 mg/kg (for all uses except food for infants and 
young children)  
E 341 (ii) DICALCIUM PHOSPHATE 
Synonyms  Dibasic calcium phosphate; Dicalcium orthophosphate  
Definition  
Einecs  231-826-1  
Chemical name  Calcium monohydrogen phosphate; Calcium hydrogen orthophos ­
phate; Secondary calcium phosphate  
Chemical formula  Anhydrous: CaHPO  4 
Dihydrate: CaHPO  4 · 2H  2 O 
Molecular weight  136,06 (anhydrous) 
172,09 (dihydrate)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 113
 
Assay  Dicalcium phosphate, after drying at 200 °C for three hours, contains 
not less than 98 % and not more than the equivalent of 102 % of CaHPO
 4 
P 2 O 5 content between 50,0 % and 52,5 % on the anhydrous basis  
Description  White crystals or granules, granular powder or powder  
Identification  
Test for calcium  Passes test  
Test for phosphate  Passes test  
Solubility  Sparingly soluble in water. Insoluble in ethanol  
Purity  
Loss on ignition  Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after 
ignition at 800 °C ± 25 °C for 30 minutes  
Fluoride  Not more than 50 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Aluminium  Not more than 100 mg/kg for the anhydrous form and not more than 
80 mg/kg for the dihydrated form (only if added to food for infants and young children) 
Not more than 600 mg/kg for the anhydrous form and not more than 
500 mg/kg for the dihydrated form (for all uses except food for infants and young children). This applies until 31 March 2015. 
Not more than 200 mg/kg for the anhydrous form and the dihydrated 
form (for all uses except food for infants and young children). This applies from 1 April 2015.
 
E 341 (iii) TRICALCIUM PHOSPHATE 
Synonyms  Calcium phosphate, tribasic; Calcium orthophosphate; Pentacalcium 
hydroxy monophosphate; Calcium hydroxyapatite  
Definition  Tricalcium phosphate consists of a variable mixture of calcium phos ­
phates obtained from neutralisation of phosphoric acid with calcium 
hydroxide and having the approximate composition of 10CaO ·3P 2 O 5 
·H 2 O 
Einecs  235-330-6 (Pentacalcium hydroxy monophosphate) 
231-840-8 (Calcium orthophosphate)  
Chemical name  Pentacalcium hydroxy monophosphate; Tricalcium monophosphate  
Chemical formula  Ca  5 (PO  4 ) 3 ·OH or Ca  3 (PO  4 ) 2 
Molecular weight  502 or 310  
Assay  Content not less than 90 % calculated on the ignited basis 
P 2 O 5 content between 38,5 % and 48,0 % on the anhydrous basis  
Description  A white, odourless powder which is stable in air  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 114
 
Identification  
Test for calcium  Passes test  
Test for phosphate  Passes test  
Solubility  Practically insoluble in water; insoluble in ethanol, soluble in dilute 
hydrochloric and nitric acid  
Purity  
Loss on ignition  Not more than 8 % after ignition at 800 °C ± 25 °C for 0,5 hour  
Fluoride  Not more than 50 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Aluminium  Not more than 150 mg/kg (only if added to food for infants and 
young children) 
Not more than 500 mg/kg (for all uses except food for infants and 
young children). This applies until 31 March 2015 
Not more than 200 mg/kg (for all uses except food for infants and 
young children). This applies from 1 April 2015.  
E 343 (i) MONOMAGNESIUM PHOSPHATE 
Synonyms  Magnesiumdihydrogenphosphate; Magnesiumphosphate, monobasic; 
Monomagnesium orthophosphate  
Definition  
Einecs  236-004-6  
Chemical name  Monomagnesiumdihydrogenmonophosphate  
Chemical formula  Mg(H  2 PO 4 ) 2 nH 2 O (where n = 0 to 4)  
Molecular weight  218,30 (anhydrous)  
Assay  Not less than 51,0 % after ignition calculated as P2O5 at the ignited 
basis (800 °C ± 25 °C for 30 minutes)  
Description  White, odourless, crystalline powder, slightly soluble in water  
Identification  
Test for magnesium  Passes test  
Test for phosphate  Passes test  
MgO content  Not less than 21,5 % after ignition or at an anhydrous basis (105 °C, 
4 hours)  
Purity  
Fluoride  Not more than 10 mg/kg (as fluorine)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 115
 
E 343 (ii) DIMAGNESIUM PHOSPHATE 
Synonyms  Magnesiumhydrogenphosphate; Magnesiumphosphate, dibasic; 
Dimagnesium orthophosphate; Secondary magnesiumphosphate  
Definition  
Einecs  231-823-5  
Chemical name  Dimagnesiummonohydrogenmonophosph ate  
Chemical formula  MgHPO  4 · nH  2 O (where n = 0-3)  
Molecular weight  120,30 (anhydrous)  
Assay  Not less than 96 % after ignition (800 °C ± 25 °C for 30 minutes)  
Description  White, odourless, crystalline powder, slightly soluble in water  
Identification  
Test for magnesium  Passes test  
Test for phosphate  Passes test  
MgO content  Not less than 33,0 % calculated on the anhydrous basis (105 °C, 4 
hours)  
Purity  
Fluoride  Not more than 10 mg/kg (as fluorine)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 350 (i) SODIUM MALATE 
Synonyms  Sodium salt of malic acid  
Definition  
Einecs  
Chemical name  Disodium DL-malate; disodium salt of hydroxybutanedioic acid  
Chemical formula  Hemihydrate: C  4 H 4 Na 2 O 5 ½ H  2 O 
Trihydrate: C  4 H 4 Na 2 O 5 3H 2 O 
Molecular weight  Hemihydrate: 187,05 
Trihydrate: 232,10  
Assay  Content not less than 98,0 % on the anhydrous basis  
Description  White crystalline powder or lumps  
Identification  
Test for 1,2-dicarboxylic acid  Passes test  
Test for sodium  Passes test  
Azo dye formation  Positive  
Solubility  Freely soluble in water  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 116
 
Purity  
Loss on drying  Hemihydrate: Not more than 7,0 % (130 °C, 4 hours) 
Trihydrate: 20,5-23,5 % (130 °C, 4 hours)  
Alkalinity  Not more than 0,2 % as Na  2 CO 3 
Fumaric acid  Not more than 1,0 %  
Maleic acid  Not more than 0,05 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 350 (ii) SODIUM HYDROGEN MALATE 
Synonyms  Monosodium salt of DL-malic acid  
Definition  
Einecs  
Chemical name  Monosodium DL-malate; monosodium 2-DL-hydroxy succinate  
Chemical formula  C  4 H 5 NaO  5 
Molecular weight  156,07  
Assay  Content not less than 99,0 % on the anhydrous basis  
Description  White powder  
Identification  
Test for 1,2-dicarboxylic acid  Passes test  
Test for sodium  Passes test  
Azo dye formation  Positive  
Purity  
Loss on drying  Not more than 2,0 % (110 °C, 3 hours)  
Maleic acid  Not more than 0,05 %  
Fumaric acid  Not more than 1,0 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 351 POTASSIUM MALATE 
Synonyms  Potassium salt of malic acid  
Definition  
Einecs  
Chemical name  Dipotassium DL-malate; dipotassium salt of hydroxybutanedioic acid  
Chemical formula  C  4 H 4 K 2 O 5 
Molecular weight  210,27  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 117
 
Assay  Content not less than 59,5 %  
Description  Colourless or almost colourless aqueous solution  
Identification  
Test for 1,2-dicarboxylic acid  Passes test  
Test for potassium  Passes test  
Azo dye formation  Positive  
Purity  
Alkalinity  Not more than 0,2 % as K  2 CO 3 
Fumaric acid  Not more than 1,0 %  
Maleic acid  Not more than 0,05 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 352 (i) CALCIUM MALATE 
Synonyms  Calcium salt of malic acid  
Definition  
Einecs  
Chemical name  Calcium DL-malate; calcium- α-hydroxysuccinate; calcium salt of 
hydroxybutanedioic acid  
Chemical formula  C  4 H 5 CaO  5 
Molecular weight  172,14  
Assay  Content not less than 97,5 % on the anhydrous basis  
Description  White powder  
Identification  
Test for malate  Passes test  
Test 1,2-dicarboxylic acid  Passes test  
Test for calcium  Passes test  
Azo dye formation  Positive  
Solubility  Slightly soluble in water  
Purity  
Loss on drying  Not more than 2 % (100 °C, 3 hours)  
Alkalinity  Not more than 0,2 % as CaCO  3 
Maleic acid  Not more than 0,05 %  
Fumaric acid  Not more than 1,0 %  
Fluoride  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 118
 
E 352 (ii) CALCIUM HYDROGEN MALATE 
Synonyms  Monocalcium salt of DL-malic acid  
Definition  
Einecs  
Chemical name  Monocalcium DL-malate; monocalcium 2-DL-hydroxysuccinate  
Chemical formula  (C  4 H 5 O 5 ) 2 Ca 
Molecular weight  
Assay  Content not less than 97,5 % on the anhydrous basis  
Description  White powder  
Identification  
Test for 1,2-dicarboxylic acid  Passes test  
Test for calcium  Passes test  
Azo dye formation  Positive  
Purity  
Loss on drying  Not more than 2,0 % (110 °C, 3 hours)  
Maleic acid  Not more than 0,05 %  
Fumaric acid  Not more than 1,0 %  
Fluoride  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 353 METATARTARIC ACID 
Synonyms  Ditartaric acid  
Definition  
Einecs  
Chemical name  Metatartaric acid  
Chemical formula  C  4 H 6 O 6 
Molecular weight  
Assay  Not less than 99,5 %  
Description  Crystalline or powder form with a white or yellowish colour. Very 
deliquescent with a faint odour of caramel  
Identification  
Solubility  Very soluble in water and ethanol  
Identification test  Place a sample of 1 to 10 mg of this substance in a test tube with 
2 ml of concentrated sulphuric acid and 2 drops of sulpho-resorcinol 
reagent. When heated to 150 °C, an intense violet coloration appears  
Purity  
Arsenic  Not more than 3 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 119
 
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 354 CALCIUM TARTRATE 
Synonyms  L-Calcium tartrate  
Definition  
Einecs  
Chemical name  Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate  
Chemical formula  C  4 H 4 CaO  6 · 2H  2 O 
Molecular weight  224,18  
Assay  Not less than 98,0 %  
Description  Fine crystalline powder with a white or off-white colour  
Identification  
Solubility  Slightly soluble in water. Solubility approximately 0,01 g/100 ml 
water (20 °C). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids
 
Specific rotation  [ α] D 20 + 7,0° to + 7,4° (0,1 % in a 1N HCl solution)  
pH Between 6,0 and 9,0 (5 % slurry)  
Purity  
Sulphates  Not more than 1 g/kg (as H  2 SO 4 ) 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 355 ADIPIC ACID 
Synonyms  
Definition  
Einecs  204-673-3  
Chemical name  Hexanedioic acid; 1,4-butanedicarboxylic acid  
Chemical formula  C  6 H 10 O 4 
Molecular weight  146,14  
Assay  Content not less than 99,6 %  
Description  White odourless crystals or crystalline powder  
Identification  
Melting range  151,5-154,0 °C  
Solubility  Slightly soluble in water. Freely soluble in ethanol  
Purity  
Water  Not more than 0,2 % (Karl Fischer method)  
Sulphated ash  Not more than 20 mg/kg  
Arsenic  Not more than 3 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 120
 
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 356 SODIUM ADIPATE 
Synonyms  
Definition  
Einecs  231-293-5  
Chemical name  Sodium adipate  
Chemical formula  C  6 H 8 Na 2 O 4 
Molecular weight  190,11  
Assay  Content not less than 99,0 % (on anhydrous basis)  
Description  White odourless crystals or crystalline powder  
Identification  
Melting range  151-152 °C (for adipic acid)  
Solubility  Approximately 50 g/100 ml water (20 °C)  
Test for sodium  Passes test  
Purity  
Water content  Not more than 3 % (Karl Fischer)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 357 POTASSIUM ADIPATE 
Synonyms  
Definition  
Einecs  242-838-1  
Chemical name  Potassium adipate  
Chemical formula  C  6 H 8 K 2 O 4 
Molecular weight  222,32  
Assay  Content not less than 99,0 % (on anhydrous basis)  
Description  White odourless crystals or crystalline powder  
Identification  
Melting range  151-152 °C (for adipic acid)  
Solubility  Approximately 60 g/100 ml water (20 °C)  
Test for potassium  Passes test  
Purity  
Water  Not more than 3 % (Karl Fischer)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 121
 
E 363 SUCCINIC ACID 
Synonyms  
Definition  
Einecs  203-740-4  
Chemical name  Butanedioic acid  
Chemical formula  C  4 H 6 O 4 
Molecular weight  118,09  
Assay  Content no less than 99,0 %  
Description  Colourless or white, odourless crystals  
Identification  
Melting range  185,0-190,0 °C  
Purity  
Residue on ignition  Not more than 0,025 % (800 °C, 15 min)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 380 TRIAMMONIUM CITRATE 
Synonyms  Tribasic ammonium citrate  
Definition  
Einecs  222-394-5  
Chemical name  Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid  
Chemical formula  C  6 H 17 N 3 O 7 
Molecular weight  243,22  
Assay  Content not less than 97,0 %  
Description  White to off-white crystals or powder  
Identification  
Test for ammonium  Passes test  
Test for citrate  Passes test  
Solubility  Freely soluble in water  
Purity  
Oxalate  Not more than 0,04 % (as oxalic acid)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 122
 
E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE 
Synonyms  Calcium disodium EDTA; Calcium disodium edetate  
Definition  
Einecs  200-529-9  
Chemical name  N,N ′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)- 
O,O′,O N ,O N ]calciate(2)-disodium; Calcium disodium ethylenedia ­
minetetra acetate; Calcium disodium (ethylenedinitrilo)tetra acetate  
Chemical formula  C  10 H 12 O 8 CaN  2 Na 2 ·2H 2 O 
Molecular weight  410,31  
Assay  Content not less than 97 % on the anhydrous basis  
Description  White, odourless crystalline granules or white to nearly white 
powder, slightly hygroscopic  
Identification  
Test for sodium  Passes test  
Test for calcium  Passes test  
Chelating activity to metal ions  Positive  
pH Between 6,5 and 7,5 (1 % solution)  
Purity  
Water content  5 to 13 % (Karl Fischer method)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 392 EXTRACTS OF ROSEMARY 
Synonyms  Extract of rosemary leaf (antioxidant)  
Definition  Extracts of rosemary contain several components, which have been 
proven to exert antioxidative functions. These components belong 
mainly to the classes of phenolic acids, flavonoids, diterpenoids. Besides the antioxidant compounds, the extracts can also contain triterpenes and organic solvent extractable material specifically 
defined in the following specification.
 
Einecs  283-291-9  
Chemical name  Rosemary extract ( Rosmarinus officinalis ) 
Description  Rosemary leaf extract antioxidant is prepared by extraction of the 
leaves of  Rosmarinus officinalis  using a food approved solvent 
system. Extracts may then be deodorised and decolourised. 
Extracts may be standardised.  
Identification  
Reference antioxidative compounds: 
phenolic diterpenes  Carnosic acid (C  20 H 28 O 4 ) and Carnosol (C  20 H 26 O 4 ) 
(which comprise not less than 90 % of the total phenolic diterpenes)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 123
 
Reference key volatiles  Borneol, Bornyl Acetate, Camphor, 1,8-Cineol, Verbenone  
Density  > 0,25 g/ml  
Solubility  Insoluble in water  
Purity  
Loss of drying  < 5 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
1 — Extracts of rosemary produced from dried rosemary leaves by acetone 
extraction. 
Description  Extracts of rosemary are produced from dried rosemary leaves by 
acetone extraction, filtration, purification and solvent evaporation, 
followed by drying and sieving to obtain a fine powder or a liquid.  
Identification  
Content of reference antioxidative 
compounds  ≥ 10 % w/w, expressed as the total of carnosic acid and carnosol  
Antioxidant/Volatiles — Ratio  (Total % w/w of carnosic acid and carnosol) ≥ 15 
(% w/w of reference key volatiles)* 
(* as a percentage of total volatiles in the extract, measured by Gas 
Chromatography — Mass Spectrometry Detection, ‘GC-MSD’)  
Purity  
Residual solvents  Acetone: Not more than 500 mg/kg  
2 — Extracts of rosemary prepared by extraction of dried rosemary leaves 
by means of supercritical carbon dioxide. 
Description  Extracts of rosemary produced from dried rosemary leaves extracted 
by means of supercritical carbon dioxide with a small amount of 
ethanol as entrainer.  
Identification  
Content of reference antioxidative 
compounds  ≥ 13 % w/w, expressed as the total of carnosic acid and carnosol  
Antioxidant/Volatiles – Ratio  (Total % w/w of carnosic acid and carnosol) ≥ 15 
(% w/w of reference key volatiles)* 
(* as a percentage of total volatiles in the extract, measured by Gas 
Chromatography — Mass Spectrometry Detection, ‘GC-MSD’)  
Purity  
Residual solvents  Ethanol: not more than 2 %  
3 — Extracts of rosemary prepared from a deodorised ethanolic extract of 
rosemary. 
Description  Extracts of rosemary which are prepared from a deodorised ethanolic 
extract of rosemary. The extracts may be further purified, for 
example by treatment with active carbon and/or molecular distil ­
lation. The extracts may be suspended in suitable and approved carriers or spray dried.
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 124
 
Identification  
Content of reference antioxidative 
compounds  ≥ 5 % w/w, expressed as the total of carnosic acid and carnosol  
Antioxidant/Volatiles – Ratio  (Total % w/w of carnosic acid and carnosol) ≥ 15 
(% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas 
Chromatography – Mass Spectrometry Detection, ‘GC-MSD’)
 
Purity  
Residual solvents  Ethanol: not more than 500 mg/kg  
4 — Extracts of rosemary decolourised and deodorised, obtained by a two- 
step extraction using hexane and ethanol. 
Description  Extracts of rosemary which are prepared from a deodorised ethanolic 
extract of rosemary, undergone a hexane extraction. The extract may be further purified, for example by treatment with active carbon and/ 
or molecular distillation. They may be suspended in suitable and 
approved carriers or spray dried.
 
Identification  
Content of reference antioxidative 
compounds  ≥ 5 % w/w, expressed as the total of carnosic acid and carnosol  
Antioxidant/Volatiles – Ratio  (Total % w/w of carnosic acid and carnosol) ≥ 15 
(% w/w of reference key volatiles)* 
(* as a percentage of total volatiles in the extract, measured by Gas 
Chromatography – Mass Spectrometry Detection, ‘GC-MSD’)  
Purity  
Residual solvents  Hexane: not more than 25 mg/kg 
Ethanol: not more than 500 mg/kg  
E 400 ALGINIC ACID 
Synonyms  
Definition  Linear glycuronoglycan consisting mainly of β-(1-4) linked D- 
mannuronic and α-(1-4) linked L-guluronic acid units in pyranose 
ring form. Hydrophilic colloidal carbohydrate extracted by the use of 
dilute alkali from strains of various species of brown seaweeds (Phaeophyceae )
 
Einecs  232-680-1  
Chemical name  
Chemical formula  (C  6 H 8 O 6 ) n 
Molecular weight  10 000-600 000 (typical average)  
Assay  Alginic acid yields, on the anhydrous basis, not less than 20 % and 
not more than 23 % of carbon dioxide (CO  2 ), equivalent to not less 
than 91 % and not more than 104,5 % of alginic acid (C  6 H 8 O 6 ) n 
(calculted on equivalent weight basis of 200)  
Description  Alginic acid occurs in filamentous, grainy, granular and powdered 
forms. It is a white to yellowish brown and nearly odourless  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 125
 
Identification  
Solubility  Insoluble in water and organic solvents, slowly soluble in solutions 
of sodium carbonate, sodium hydroxide and trisodium phosphate  
Calcium chloride precipitation test  To a 0,5 % solution of the sample in 1 M sodium hydroxide solution 
add one fifth of its volume of a 2,5 % solution of calcium chloride. 
A voluminous, gelatinous precipitate is formed. This test distin ­
guishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, 
karaya gum, locust bean gum, methyl cellulose and tragacanth gum.
 
Ammonium sulphate precipitation test  To a 0,5 % solution of the sample in 1 M sodium hydroxide solution 
add one half of its volume of a saturated solution of ammonium 
sulphate. No precipitate is formed. This test distinguishes alginic 
acid from agar, sodium carboxymethyl cellulose, carrageenan, de- esterified pectin, gelatin, locust bean gum, methyl cellulose and starch.
 
Colour reaction  Dissolve as completely as possible 0,01 g of the sample by shaking 
with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric 
sulphate solution. Within 5 minutes a cherry-red colour develops that 
finally becomes deep purple.  
pH Between 2,0 and 3,5 (3 % suspension)  
Purity  
Loss on drying  Not more than 15 % (105 °C, 4 hours)  
Sulphated ash  Not more than 8 % on the anhydrous basis  
Sodium hydroxide (1 M solution) 
insoluble matter  Not more than 2 % on the anhydrous basis  
Formaldehyde  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 5 000 colonies per gram  
Yeast and moulds  Not more than 500 colonies per gram  
Escherichia coli  Absent in 5 g  
Salmonella  spp.  Absent in 10 g  
E 401 SODIUM ALGINATE 
Synonyms  
Definition  
Einecs  
Chemical name  Sodium salt of alginic acid  
Chemical formula  (C  6 H 7 NaO  6 ) n 
Molecular weight  10 000-600 000 (typical average)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 126
 
Assay  Yields, on the anhydrous basis, not less than 18 % and not more 
than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on 
equivalent weight basis of 222)
 
Description  Nearly odourless, white to yellowish fibrous or granular powder  
Identification  
Test for sodium  Passes test  
Test for alginic acid  Passes test  
Purity  
Loss on drying  Not more than 15 % (105 °C, 4 hours)  
Water insoluble matter  Not more than 2 % on the anhydrous basis  
Formaldehyde  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 5 000 colonies per gram  
Yeast and moulds  Not more than 500 colonies per gram  
Escherichia coli  Absent in 5 g  
Salmonella  spp.  Absent in 10 g  
E 402 POTASSIUM ALGINATE 
Synonyms  
Definition  
Einecs  
Chemical name  Potassium salt of alginic acid  
Chemical formula  (C  6 H 7 KO  6 ) n 
Molecular weight  10 000-600 000 (typical average)  
Assay  Yields, on the anhydrous basis, not less than 16,5 % and not more 
than 19,5 % of carbon dioxide corresponding to not less than 89,2 % 
and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)
 
Description  Nearly odourless, white to yellowish fibrous or granular powder  
Identification  
Test for potassium  Passes test  
Test for alginic acid  Passes test  
Purity  
Loss on drying  Not more than 15 % (105 °C, 4 hours)  
Water insoluble matter  Not more than 2 % on the anhydrous basis  
Formaldehyde  Not more than 50 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 127
 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 5 000 colonies per gram  
Yeast and moulds  Not more than 500 colonies per gram  
Escherichia coli  Absent in 5 g  
Salmonella  spp.  Absent in 10 g  
E 403 AMMONIUM ALGINATE 
Synonyms  
Definition  
Einecs  
Chemical name  Ammonium salt of alginic acid  
Chemical formula  (C  6 H 11 NO  6 ) n 
Molecular weight  10 000-600 000 (typical average)  
Assay  Yields, on the anhydrous basis, not less than 18 % and not more 
than 21 % of carbon dioxide corresponding to not less than 88,7 % 
and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217)
 
Description  White to yellowish fibrous or granular powder  
Identification  
Test for ammonium  Passes test  
Test for alginic acid  Passes test  
Purity  
Loss on drying  Not more than 15 % (105 °C, 4 hours)  
Sulphated ash  Not more than 7 % on the dried basis  
Water insoluble matter  Not more than 2 % on the anhydrous basis  
Formaldehyde  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 5 000 colonies per gram  
Yeast and moulds  Not more than 500 colonies per gram  
Escherichia coli  Absent in 5 g  
Salmonella  spp.  Absent in 10 g  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 128
 
E 404 CALCIUM ALGINATE 
Synonyms  Calcium salt of alginate  
Definition  
Einecs  
Chemical name  Calcium salt of alginic acid  
Chemical formula  (C  6 H 7 Ca 1/2 O 6 ) n 
Molecular weight  10 000-600 000 (typical average)  
Assay  Yields, on the anhydrous basis, not less than 18 % and not more 
than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219)
 
Description  Nearly odourless, white to yellowish fibrous or granular powder  
Identification  
Test for calcium  Passes test  
Test for alginic acid  Passes test  
Purity  
Loss on drying  Not more than 15,0 % (105 °C, 4 hours)  
Formaldehyde  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 5 000 colonies per gram  
Yeast and moulds  Not more than 500 colonies per gram  
Escherichia coli  Absent in 5 g  
Salmonella  spp.  Absent in 10 g  
E 405 PROPANE-1,2-DIOL ALGINATE 
Synonyms  Hydroxypropyl alginate; 1,2-Propanediol ester of alginic acid; 
Propylene glycol alginate  
Definition  
Einecs  
Chemical name  1,2-Propanediol ester of alginic acid; varies in composition 
according to its degree of esterification and the percentage of free 
and neutralised carboxyl groups in the molecule  
Chemical formula  (C  9 H 14 O 7 ) n (esterified)  
Molecular weight  10 000-600 000 (typical average)  
Assay  Yields, on the anhydrous basis, not less than 16 % and not more 
than 20 % of carbon dioxide (CO  2) 
Description  Nearly odourless, white to yellowish brown fibrous or granular 
powder  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 129
 
Identification  
Test for 1,2-propanediol  Passes test (after hydrolysis)  
Test for alginic acid  Passes test (after hydrolysis)  
Purity  
Loss on drying  Not more than 20 % (105 °C, 4 hours)  
Total propane-1,2-diol content  Not less than 15 % and not more than 45 %  
Free propane-1,2-diol content  Not more than 15 %  
Water insoluble matter  Not more than 2 % on the anhydrous basis  
Formaldehyde  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 5 000 colonies per gram  
Yeast and moulds  Not more than 500 colonies per gram  
Escherichia coli  Absent in 5 g  
Salmonella  spp.  Absent in 10 g  
E 406 AGAR 
Synonyms  Gelose; Kanten, Bengal, Ceylon, Chinese or Japanese isinglass; 
Layor Carang  
Definition  Agar is a hydrophilic colloidal polysaccharide consisting mainly of 
galactose units with a regular alternation of L and D isomeric forms. 
These hexoses are alternately linked with alpha-1,3 and beta-1,4 bonds in the copolymer. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid 
which is neutralised by calcium, magnesium, potassium or sodium. 
It is extracted from certain strains of marine algae of the families  
Gelidiaceae  and Gracilariaceae  and relevant red algae of the class  
Rhodophyceae
 
Einecs  232-658-1  
Chemical name  
Chemical formula  
Molecular weight  
Assay  The threshold gel concentration should not be higher than 0,25 %  
Description  Agar is odourless or has a slight characteristic odour. Unground agar 
usually occurs in bundles consisting of thin, membranous, agglu ­
tinated strips, or in cut, flaked or granulated forms. It may be light yellowish-orange, yellowish-grey to pale yellow, or colourless. 
It is tough when damp, brittle when dry. Powdered agar is white to 
yellowish-white or pale yellow. When examined in water under a microscope, agar powder appears more transparent. In chloral hydrate solution, the powdered agar appears more transparent than 
in water, more or less granular, striated, angular and occasionally 
contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltodextrines or sucrose
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 130
 
Identification  
Solubility  Insoluble in cold water; soluble in boiling water  
Purity  
Loss on drying  Not more than 22 % (105 °C, 5 hours)  
Ash Not more than 6,5 % on the anhydrous basis determined at 550 °C  
Acid-insoluble ash (insoluble in approxi ­
mately 3N Hydrochloric acid)  Not more than 0,5 % determined at 550 °C on the anhydrous basis  
Insoluble matter (after stirring for 10 
minutes in hot water)  Not more than 1,0 %  
Starch  Not detectable by the following method: to a 1 in 10 solution of the 
sample add a few drops of iodine solution. No blue colour is 
produced  
Gelatin and other proteins  Dissolve about 1 g of agar in 100 ml of boiling water and allow to 
cool of about 50 °C. To 5 ml of the solution add 5 ml of trinitro ­
phenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes
 
Water absorption  Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark 
with water, mix and allow to stand at about 25 °C for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing 
the water to drain into a second 100 ml graduated cylinder. Not 
more than 75 ml of water is obtained
 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 5 000 colonies per gram  
Yeast and moulds  Not more than 300 colonies per gram  
Escherichia coli  Absent in 5 g  
Salmonella  spp.  Absent in 5 g  
E 407 CARRAGEENAN 
Synonyms  Products of commerce are sold under different names such as: 
Irish moss gelose; Eucheuman (from  Eucheuma  spp.); Iridophycan 
(from  Iridaea  spp.); Hypnean (from  Hypnea  spp.); Furcellaran or 
Danish agar (from  Furcellaria fastigiata ); Carrageenan (from  
Chondrus  and  Gigartina  spp.)  
Definition  Carrageenan is obtained by extraction with water or dilute aqueous 
alkali of strains of seaweeds of  Gigartinaceae , Solieriaceae , 
Hypneaceae  and  Furcellariaceae , families of the class  Rhodo­
phyceae  (red seaweeds). 
Carrageenan consists chiefly of the potassium, sodium, magnesium 
and calcium sulphate esters of galactose and 3,6-anhydrogalactose 
polysacharide. These hexoses are alternately linked α-1,3 and β-1,4 
in the copolymer.  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 131
 
The prevalent polysaccharides in carrageenan are designated as 
kappa, iota, lambda depending on the number of sulphate by 
repeating unit (i.e. 1,2,3 sulphate). Between kappa and iota there 
is a continuum of intermediate compositions differing in number of sulphates per repeat units between 1 and 2. 
During the process, no organic precipitant shall be used other than 
methanol, ethanol and propan-2-ol. 
The wording carrageenan is reserved for the non hydrolysed or 
otherwise chemically degraded polymer. 
Formaldehyde may be present as an adventitious impurity up to a 
maximum of 5 mg/kg.
 
Einecs  232-524-2  
Chemical name  Sulphate esters of polygalactose  
Chemical formula  
Molecular weight  
Assay  
Description  Yellowish to colourless, coarse to fine powder which is practically 
odourless  
Identification  
Test for galactose  Passes test  
Test for anhydrogalactose  Passes test  
Test for sulphate  Passes test  
Solubility  Soluble in hot water; insoluble in alcohol for a 1,5 % dilution  
Purity  
Solvent residues  Not more than 0,1 % of methanol, ethanol, propan-2-ol, singly or in 
combination  
Viscosity  Not less than 5 mPa.s (1,5 % solution at 75 °C)  
Loss on drying  Not more than 12 % (105 °C, 4 hours)  
Sulphates  Not less than 15 % and not more than 40 % on the dried basis (as 
SO 4 ) 
Ash Not less than 15 % and not more than 40 % determined on the dried 
basis at 550 °C  
Acid-insoluble ash  Not more than 1 % on the dried basis (insoluble in 10 % hydro ­
chloric acid)  
Acid-insoluble matter  Not more than 2 % on the dried basis (insoluble in 1 % v/v 
sulphuric acid)  
Low molecular weight carrageenan (Mol ­
ecular weight fraction below 50 kDa)  Not more than 5 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 2 mg/kg  
Microbiological criteria  
Total plate count  Not more than 5 000 colonies per gram  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 132
 
Yeast and moulds  Not more than 300 colonies per gram  
Escherichia coli  Absent in 5 g  
Salmonella  spp.  Absent in 10 g  
E 407a PROCESSED EUCHEUMA SEAWEED 
Synonyms  PES (acronym for processed eucheuma seaweed). The PES obtained 
from  Euchema cottonii  is generally called kappa PES and the PES 
from  Euchema spinosum  iota PES.  
Definition  Processed eucheuma seaweed is obtained by aqueous alkaline 
(KOH) treatment at high temperature of the strains of seaweeds  
Eucheuma cottonii  and  Eucheuma spinosum , of the class  Rhodo­
phyceae  (red seaweeds) followed by fresh water washing to 
remove impurities and drying to obtain the product. Further purifi ­
cation may be achieved by washing with an alcohol. The alcohols 
authorised are restricted to methanol, ethanol or propan-2-ol. The 
product consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose poly ­
saccharide. Up to 15 % algal cellulose is also present in the product. 
The wording processed eucheuma seaweed is reserved to the non 
hydrolysed or otherwise chemically degraded polymer. Formal ­
dehyde may be present up to a maximum of 5 mg/kg.
 
Description  Tan to yellowish, coarse to fine powder which is practically 
odourless  
Identification  
Test for galactose  Passes test  
Test for anhydrogalactose  Passes test  
Test for sulphate  Passes test  
Solubility  Forms cloudy viscous suspensions in water. Insoluble in ethanol for 
a 1,5 % solution.  
Purity  
Solvent residues  Not more than 0,1 % of methanol, ethanol, propan-2-ol, singly or in 
combination  
Viscosity  Not less than 5 mPa.s (1,5 % solution at 75 °C)  
Loss on drying  Not more than 12 % (105 °C, 4 hours)  
Sulphate  Not less than 15 % and not more than 40 % on the dried basis (as 
SO 4 ) 
Ash Not less than 15 % and not more than 40 % determined on the dried 
basis at 550 °C  
Acid-insoluble ash  Not more than 1 % on the dried basis (insoluble in 10 % hydro ­
chloric acid)  
Acid-insoluble matter  Not less than 8 % and not more than 15 % on the dried basis 
(insoluble in 1 % v/v sulphuric acid)  
Low molecular weight carrageenan (Mol ­
ecular weight fraction below 50 kDa)  Not more than 5 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 133
 
Cadmium  Not more than 2 mg/kg  
Microbiological criteria  
Total plate count  Not more than 5 000 colonies per gram  
Yeast and moulds  Not more than 300 colonies per gram  
Escherichia coli  Absent in 5 g  
Salmonella  spp.  Absent in 10 g  
E 410 LOCUST BEAN GUM 
Synonyms  Carob bean gum; Algaroba gum  
Definition  Locust bean gum is the ground endosperm of the seeds of the strains 
of carob tree,  Cerationia siliqua  (L.) Taub. (family  Leguminosae ). 
Consists mainly of a high molecular weight hydrocolloidal polysac ­
charide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
 
Einecs  232-541-5  
Chemical name  
Chemical formula  
Molecular weight  50 000-3 000 000  
Assay  Galactomannan content not less than 75 %  
Description  White to yellowish-white, nearly odourless powder  
Identification  
Test for galactose  Passes test  
Test for mannose  Passes test  
Microscopic examination  Place some ground sample in an aqueous solution containing 0,5 % 
iodine and 1 % potassium iodide on a glass slide and examine under microscope. Locust bean gum contains long stretched tubiform cells, 
separated or slightly interspaced. Their brown contents are much less 
regularly formed than in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown
 
Solubility  Soluble in hot water, insoluble in ethanol  
Purity  
Loss on drying  Not more than 15 % (105 °C, 5 hours)  
Ash Not more than 1,2 % determined at 800 °C  
Protein (N × 6,25)  Not more than 7 %  
Acid-insoluble matter  Not more than 4 %  
Starch  Not detectable by the following method: to a 1 in 10 solution of the 
sample add a few drops of iodine solution. No blue colour is 
produced  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 134
 
Cadmium  Not more than 1 mg/kg  
Ethanol and propan-2-ol  Not more than 1 %, single or in combination  
E 412 GUAR GUM 
Synonyms  Gum cyamopsis; Guar flour  
Definition  Guar gum is the ground endosperm of the seeds of strains of the 
guar plant,  Cyamopsis tetragonolobus  (L.) Taub. (family  Legumi­
nosae ). Consists mainly of a high molecular weight hydrocolloidal 
polysaccharide composed of galactopyranose and mannopyranose 
units combined through glycosidic linkages, which may be 
described chemically as galactomannan. The gum may be partially hydrolysed by either heat treatment, mild acid or alcaline oxidative treatment for viscosity adjustment.
 
Einecs  232-536-0  
Chemical name  
Chemical formula  
Molecular weight  50 000-8 000 000  
Assay  Galactomannan content not less than 75 %  
Description  A white to yellowish-white, nearly odourless powder  
Identification  
Test for galactose  Passes test  
Test for mannose  Passes test  
Solubility  Soluble in cold water  
Purity  
Loss on drying  Not more than 15 % (105 °C, 5 hours)  
Ash Not more than 5,5 % determined at 800 °C  
Acid-insoluble matter  Not more than 7 %  
Protein  Not more than 10 % (factor N x 6,25)  
Starch  Not detectable by the following method: to a 1 in 10 solution of the 
sample add a few drops of iodine solution. (No blue colour is 
produced)  
Organic peroxides  Not more than 0,7 meq active oxygen/kg sample  
Furfural  Not more than 1 mg/kg  
Pentachlorophenol  Not more than 0,01 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 413 TRAGACANTH 
Synonyms  Tragacanth gum; Tragant  
Definition  Tragacanth is a dried exudation obtained from the stems and 
branches of strains of  Astragalus gummifer  Labillardiere and other 
Asiatic species of  Astragalus  (family  Leguminosae ). It consists 
mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic 
acid, galactose, arabinose, xylose and fucose. Small amounts of 
rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 135
 
Einecs  232-252-5  
Chemical name  
Chemical formula  
Molecular weight  Approximately 800 000  
Assay  
Description  Unground Tragacanth gum occurs as flattened, lamellated, straight or 
curved fragments or as spirally twisted pieces 0,5-2,5 mm thick and 
up to 3 cm in length. It is white to pale yellow in colour but some 
pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid muci ­
laginous taste. Powdered tragacanth is white to pale yellow or 
pinkish brown (pale tan) in colour
 
Identification  
Solubility  1 g of the sample in 50 ml of water swells to form a smooth, stiff, 
opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol
 
Purity  
Test for Karaya gum  Negative. Boil 1 g with 20 ml of water until a mucilage is formed. 
Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops
 
Loss on drying  Not more than 16 % (105 °C, 5 hours)  
Total ash  Not more than 4 %  
Acid insoluble ash  Not more than 0,5 %  
Acid insoluble matter  Not more than 2 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Microbiological criteria  
Salmonella  spp.  Absent in 10 g  
Escherichia coli  Absent in 5 g  
E 414 ACACIA GUM 
Synonyms  Gum arabic  
Definition  Acacia gum is a dried exudation obtained from the stems and 
branches of strains of  Acacia senegal  (L) Willdenow or closely 
related species of Acacia (family  Leguminosae ). It consists mainly 
of high molecular weight polysaccharides and their calcium, 
magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid
 
Einecs  232-519-5  
Chemical name  
Chemical formula  
Molecular weight  Approximately 350 000  
Assay  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 136
 
Description  Unground acacia gum occurs as white or yellowish-white spheroidal 
tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of 
white to yellowish-white flakes, granules, powder or spray-dried 
material.
 
Identification  
Solubility  1 g dissolves in 2 ml of cold water forming a solution which flows 
readily and is acid to litmus, insoluble in ethanol  
Purity  
Loss on drying  Not more than 17 % (105 °C, 5 hours) for granular and not more 
than 10 % (105 °C, 4 hours) for spray-dried material  
Total ash  Not more than 4 %  
Acid insoluble ash  Not more than 0,5 %  
Acid insoluble matter  Not more than 1 %  
Starch or dextrin  Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of 
iodine solution. No bluish or reddish colours are produced  
Tannin  To 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride 
solution (9 g FeCl  3 .6H  2 O made up to 100 ml with water). No 
blackish colouration or blackish precipitate is formed  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Hydrolysis products  Mannose, xylose and galacturonic acid are absent (determined by 
chromatography)  
Microbiological criteria  
Salmonella  spp.  Absent in 10 g  
Escherichia coli  Absent in 5 g  
E 415 XANTHAN GUM 
Synonyms  
Definition  Xanthan gum is a high molecular weight polysaccharide gum 
produced by a pure-culture fermentation of a carbohydrate with 
strains of  Xanthomonas campestris , purified by recovery with 
ethanol or propan-2-ol, dried and milled. It contains D-glucose and 
D-mannose as the dominant hexose units, along with D-glucuronic 
acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral
 
Einecs  234-394-2  
Chemical name  
Chemical formula  
Molecular weight  Approximately 1 000 000  
Assay  Yields, on dried basis, not less than 4,2 % and not more than 5 % of 
CO 2 corresponding to between 91 % and 108 % of xanthan gum  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 137
 
Description  Cream-coloured powder  
Identification  
Solubility  Soluble in water. Insoluble in ethanol  
Purity  
Loss on drying  Not more than 15 % (105 °C, 2,5 hours)  
Total ash  Not more than 16 % on the anhydrous basis determined at 650 °C 
after drying at 105 °C for four hours  
Pyruvic acid  Not less than 1,5 %  
Nitrogen  Not more than 1,5 %  
Ethanol and propan-2-ol  Not more than 500 mg/kg singly or in combination  
Lead  Not more than 2 mg/kg  
Microbiological criteria  
Total plate count  Not more than 5 000 colonies per gram  
Yeast and moulds  Not more than 300 colonies per gram  
Escherichia coli  Absent in 5 g  
Salmonella  spp.  Absent in 10 g  
Xanthomonas campestris  Viable cells absent in 1 g  
E 416 KARAYA-GUM 
Synonyms  Katilo; Kadaya; Gum  sterculia ; Sterculia ; Karaya, gum karaya; 
Kullo; Kuterra  
Definition  Karaya gum is a dried exudation from the stems and branches of 
strains of:  Sterculia urens  Roxburgh and other species of  Sterculia  
(family  Sterculiaceae ) or from  Cochlospermum gossypium  A.P. De 
Candolle or other species of  Cochlospermum  (family  Bixaceae ). It 
consists mainly of high molecular weight acetylated polysaccharides, 
which on hydrolysis yield galactose, rhamnose, and galacturonic 
acid, together with minor amounts of glucuronic acid  
Einecs  232-539-4  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Karaya gum occurs in tears of variable size and in broken irregular 
pieces having a characteristic semi-crystalline appearance. It is pale yellow to pinkish brown in colour, translucent and horny. Powdered karaya gum is a pale grey to pinkish brown. The gum has a 
distinctive odour of acetic acid
 
Identification  
Solubility  Insoluble in ethanol  
Swelling in ethanol solution  Karaya gum swells in 60 % ethanol distinguishing it from other 
gums  
Purity  
Loss on drying  Not more than 20 % (105 °C, 5 hours)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 138
 
Total ash  Not more than 8 %  
Acid insoluble ash  Not more than 1 %  
Acid insoluble matter  Not more than 3 %  
Volatile acid  Not less than 10 % (as acetic acid)  
Starch  Not detectable  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Microbiological criteria  
Salmonella  spp.  Absent in 10 g  
Escherichia coli  Absent in 5 g  
E 417 TARA GUM 
Definition  Tara gum is obtained by grinding the endosperm of the seeds of 
strains of  Caesalpinia spinosa  (family  Leguminosae ). It consists 
chiefly of polysaccharides of high molecular weight composed 
mainly of galactomannans. The principal component consists of a linear chain of (1-4)- β-D-mannopyranose units with α-D-galactopy ­
ranose units attached by (1-6) linkages. The ratio of mannose to 
galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 
and in guar gum 2:1)
 
Einecs  254-409-6  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  A white to white-yellow odourless powder  
Identification  
Solubility  Soluble in water, insoluble in ethanol  
Gel formation  To an aqueous solution of the sample add small amounts of sodium 
borate. A gel is formed  
Purity  
Loss on drying  Not more than 15 %  
Ash Not more than 1,5 %  
Acid insoluble matter  Not more than 2 %  
Protein  Not more than 3,5 % (factor N x 5,7)  
Starch  Not detectable  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 139
 
E 418 GELLAN GUM 
Synonyms  
Definition  Gellan gum is a high molecular weight polysaccharide gum 
produced by a pure culture fermentation of a carbohydrate by strains of  Pseudomonas elodea , purified by recovery with propan- 
2-ol or ethanol, dried, and milled. The high molecular weight poly ­
saccharide is principally composed of a tetrasaccharide repeating unit 
of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O-glyco ­
sidically linked esters. The glucuronic acid is neutralised to a mixed 
potassium, sodium, calcium, and magnesium salt
 
Einecs  275-117-5  
Chemical name  
Chemical formula  
Molecular weight  Approximately 500 000  
Assay  Yields, on the dried basis, not less than 3,3 % and not more than 
6,8 % of CO  2 
Description  An off-white powder  
Identification  
Solubility  Soluble in water, forming a viscous solution. 
Insoluble in ethanol  
Purity  
Loss on drying  Not more than 15 % after drying (105 °C, 2,5 hours)  
Nitrogen  Not more than 3 %  
Propan-2-ol  Not more than 750 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 10 000 colonies per gram  
Yeast and moulds  Not more than 400 colonies per gram  
Escherichia coli  Negative in 5 g  
Salmonella  spp.  Negative in 10 g  
E 420 (i) SORBITOL 
Synonyms  D-glucitol; D-sorbitol  
Definition  Sorbitol is obtained by hydrogenation of D-glucose. It is mainly 
composed of D-sorbitol. According to the level of D-glucose, the 
part of the products which is not D-sorbitol is composed of related 
substances such as mannitol, iditol, maltitol.  
Einecs  200-061-5  
Chemical name  D-glucitol  
Chemical formula  C  6 H 14 O 6 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 140
 
Molecular weight  182,2  
Assay  Content not less than 97 % of total glycitols and not less than 91 % 
of D-sorbitol on dry weight basis (glycitols are compounds with the structural formula CH
 2 OH-(CHOH)  n -CH  2 OH, where ‘ n’ is an 
integer).  
Description  White hygroscopic powder, crystalline powder, flakes or granules.  
Appearance of the aqueous solution:  The solution is clear.  
Identification  
Solubility  Very soluble in water, slightly soluble in ethanol  
Melting range  88 to 102 °C  
Sorbitol monobenzylidene derivative  To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde 
and 1 ml of hydrochloric acid. Mix and shake in a mechanical 
shaker until crystals appear. Filter with the aid of suction, dissolve 
the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, 
wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. 
The crystals so obtained melt between 173 and 179 °C
 
▼M4 
Purity  
Water content  Not more than 1,5 % (Karl Fischer Method)  
Conductivity  Not more than 20 μS/cm (on 20 % dry solids solution) at 
temperature 20 °C  
Reducing sugars  Not more than 0,3 % (expressed as glucose on dry weight basis)  
Total sugars  Not more than 1 % (expressed as glucose on dry weight basis)  
Nickel  Not more than 2 mg/kg (expressed on dry weight basis)  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
▼B 
E 420 (ii) SORBITOL SYRUP 
Synonyms  D-glucitol syrup  
Definition  Sorbitol syrup formed by hydrogenation of glucose syrup is 
composed of D-sorbitol, D-mannitol and hydrogenated saccharides. 
The part of the product which is not D-sorbitol is composed mainly 
of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is 
non-crystallising) or mannitol. Minor quantities of glycitols where  
n ≤ 4 may be present (glycitols are compounds with the structural 
formula CH
 2 OH-(CHOH)  n -CH  2 OH, where ‘ n’ is an integer)  
Einecs  270-337-8  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 69 % total solids and not less than 50 % of D- 
sorbitol on the anhydrous basis  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 141
 
Description  Clear and colourless aqueous solution  
Identification  
Solubility  Miscible with water, with glycerol, and with propane-1,2-diol  
Sorbitol monobenzylidene derivative  To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde 
and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve 
the crystals in 20 ml of boiling water containing 1 g of sodium 
bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C
 
▼M4 
Purity  
Water content  Not more than 31 % (Karl Fischer Method)  
Conductivity  Not more than 10 μS/cm (on the product as such) at temperature 
20 °C  
Reducing sugars  Not more than 0,3 % (expressed as glucose on dry weight basis)  
Nickel  Not more than 2 mg/kg (expressed on dry weight basis)  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
E 421 (i) MANNITOL BY HYDROGENATION  
▼B 
(i) MANNITOL  
Synonyms  D-mannitol  
▼M4 
Definition  Manufactured by catalytic hydrogenation of carbohydrate solutions 
containing glucose and/or fructose. 
The product contains min. 96 % mannitol. The part of the product 
which is not mannitol is mainly composed of sorbitol (2 % max), 
maltitol (2 % max) and isomalt (1,1 GPM (1-O-alpha-D-Glucopy ­
ranosyl-D-mannitol dehydrate): 2 % max and 1,6 GPS (6-O-alpha-D- Glucopyranosyl-D-Sorbitol): 2 % max). Unspecified impurities shall 
not represent more than 0,1 % of each.
 
▼B 
Einecs  200-711-8  
Chemical name  D-mannitol  
Chemical formula  C  6 H 14 O 6 
Molecular weight  182,2  
Assay  Content not less than 96,0 % D-mannitol and not more than 102 % 
on the dried basis  
Description  White, odourless, crystalline powder  
Identification  
Solubility  Soluble in water, very slightly soluble in ethanol, practically 
insoluble in ether  
Melting range  Between 164 and 169 °C  
Infrared absorption spectrometry  Comparison with a reference standard e.g. EP or USP  
Specific rotation  [ α] D 20 + 23° to + 25° (borate solution)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 142
 
pH Between 5 and 8. Add 0,5 ml of a saturated solution of potassium 
chloride to 10 ml of a 10 % w/v solution of the sample, then 
measure the pH  
▼M4 
Purity  
Water content  Not more than 0,5 % (Karl Fischer Method)  
Conductivity  Not more than 20 μS/cm (on 20 % dry solids solution) at 
temperature 20 °C  
Reducing sugars  Not more than 0,3 % (expressed as glucose)  
Total sugars  Not more than 1 % (expressed as glucose)  
Nickel  Not more than 2 mg/kg  
Lead  Not more than 1 mg/kg  
▼B 
(ii) MANNITOL MANUFACTURED BY FERMENTATION  
Synonyms  D-mannitol  
Definition  Manufactured by discontinuous fermentation under aerobic 
conditions using a conventional strain of the yeast  Zygosacchar ­
omyces rouxii.  The part of the product which is not mannitol is 
mainly composed of sorbitol, maltitol and isomalt.  
Einecs  200-711-8  
Chemical name  D-mannitol  
Chemical formula  C  6 H 14 O 6 
Molecular weight  182,2  
Assay  Not less than 99 % on the dried basis  
Description  White, odourless crystalline powder  
Identification  
Solubility  Soluble in water, very slightly soluble in ethanol, practically 
insoluble in ether  
Melting range  Between 164 and 169 °C  
Infrared absorption spectrometry  Comparison with a reference standard e.g. EP or USP  
Specific rotation  [ α] D 20 + 23° to + 25° (borate solution)  
pH Between 5 and 8 
Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of 
a 10 % w/v solution of the sample, then measure the pH  
▼M4 
Purity  
Arabitol  Not more than 0,3 %  
Water content  Not more than 0,5 % (Karl Fischer Method)  
Conductivity  Not more than 20 μS/cm (on 20 % dry solids solution) at 
temperature 20 °C  
Reducing sugars  Not more than 0,3 % (expressed as glucose)  
Total sugars  Not more than 1 % (expressed as glucose)  
Lead  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 143
 
Microbiological criteria  
Aerobic mesophilic bacteria  Not more than 1 000 colonies per gram  
Coliforms  Absent in 10 g  
Salmonella  spp.  Absent in 25 g  
Escherichia coli  Absent in 10 g  
Staphylococcus aureus  Absent in 10 g  
Pseudomonas aeruginosa  Absent in 10 g  
Moulds  Not more than 100 colonies per gram  
Yeasts  Not more than 100 colonies per gram  
E 422 GLYCEROL 
Synonyms  Glycerin; Glycerine  
Definition  
Einecs  200-289-5  
Chemical name  1,2,3-propanetriol; Glycerol; Trihydroxypropane  
Chemical formula  C  3 H 8 O 3 
Molecular weight  92,10  
Assay  Content not less than 98 % of glycerol on the anhydrous basis  
Description  Clear, colourless hygroscopic syrupy liquid with not more than a 
slight characteristic odour, which is neither harsh nor disagreeable  
Identification  
Acrolein formation on heating  Heat a few drops of the sample in a test tube with about 0,5 g of 
potassium bisulphate. The characteristic pungent vapours of acrolein 
are evolved  
Specific gravity (25 °C/25 °C)  Not less than 1,257  
Refractive index  [n]  D 20 between 1,471 and 1,474  
Purity  
Water content  Not more than 5 % (Karl Fischer method)  
Sulphated ash  Not more than 0,01 % determined at 800 ± 25 °C  
Butanetriols  Not more than 0,2 %  
Acrolein, glucose and ammonium 
compounds  Heat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide 
solution (1 in 10) at 60 °C for five minutes. It neither becomes 
yellow nor emits an odour of ammonia  
Fatty acids and esters  Not more than 0,1 % calculated as butyric acid  
Chlorinated compounds  Not more than 30 mg/kg (as chlorine)  
3-Monochloropropane-1,2-diol (3- 
MCPD)  Not more than 0,1 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 144
 
E 423 OCTENYL SUCCINIC ACID MODIFIED GUM ARABIC 
Synonyms  Gum arabic hydrogen octenylbutandioate; Gum arabic hydrogen 
octenylsuccinate; OSA modified gum arabic; OSA modified gum 
acacia  
Definition  Octenyl succinic acid modified gum arabic is produced by este ­
rifying gum arabic ( Acacia seyal ), or gum arabic ( Acacia senegal ) 
in aqueous solution with not more than 3 % of octenyl succinic acid 
anhydride. It is subsequently spray dried.  
Einecs  
Chemical name  
Chemical formula  
Weight Average Molecular Weight  Fraction (i): 3,105 g/mol 
Fraction (ii) 1,106 g/mol  
Assay  
Description  Off-white to light tan, free flowing powder  
Identification  
Viscosity of a 5 % solution at 25 °C  Not more than 30 mPa.s.  
Precipitation reaction  Forms flocculent precipitate in lead sub-acetate solution (TS)  
Solubility  Freely soluble in water; insoluble in ethanol  
pH for a 5 % aqueous solution  3,5 to 6,5  
Purity  
Loss on drying  Not more than 15 % (105 °C, 5 h)  
Degree of esterification  Not more than 0,6 %  
Total ash  Not more than 10 % (530 °C)  
Acid-insoluble ash  Not more than 0,5 %  
Water insoluble matter  Not more than 1,0 %  
Test for starch or dextrine  Boil a 1 in 50 aqueous solution of the sample, add about 0,1 ml 
iodine TS. No bluish or reddish colour should be produced.  
Test for tannin-bearing gums  To 10 ml of a 1 in 50 aqueous solution of the sample add about 
0,1 ml ferric chloride TS. No blackish coloration or blackish precipitate should be formed.
 
Residual octenyl succinic acid  Not more than 0,3 %  
Lead  Not more than 2 mg/kg  
Microbiological criteria  
Salmonella  sp. Absent in 25 g  
Escherichia coli  Absent in 1 g  ▼M7 2012R0231 — EN — 11.07.2014 — 008.001 — 145
 
E 425 (i) KONJAC GUM 
Synonyms  
Definition  Konjac gum is a water-soluble hydrocolloid obtained from the 
Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plant  Amorphophallus 
konjac.  The main component of Konjac gum is the water-soluble 
high-molecular-weight polysaccharide glucomannan, which consists 
of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds. Shorter side chains are 
attached through β(1-3)-glycosidic bonds, and acetyl groups occur 
at random at a ratio of about 1 group per 9 to 19 sugar units
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  The main component, glucomannan, has an average molecular 
weight of 200 000 to 2 000 000  
Assay  Not less than 75 % carbohydrate  
Description  A white to cream to light tan powder  
Identification  
Solubility  Dispersible in hot or cold water forming a highly viscous solution 
with a pH between 4,0 and 7,0  
Gel formation  Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the 
sample in a test tube, and shake vigorously. A gel forms  
Formation of heat-stable gel  Prepare a 2 % solution of the sample by heating it in a boiling water 
bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium 
carbonate solution to the fully hydrated sample at ambient 
temperature. Heat the mixture in a water bath to 85 °C, and maintain for 2 h without agitation. Under these conditions a 
thermally stable gel is formed
 
Purity  
Loss on drying  Not more than 12 % (105 °C, 5 hours)  
Starch  Not more than 3 %  
Protein  Not more than 3 % (factor N × 5,7)  
Viscosity (1 % solution)  Not less than 3 kgm  – 1 s – 1 at 25 °C  
Ether-soluble material  Not more than 0,1 %  
Total ash  Not more than 5,0 % (800 °C, 3 to 4 hours)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Microbiological criteria  
Salmonella  spp.  Absent in 12,5 g  
Escherichia coli  Absent in 5 g  
E 425 (ii) KONJAC GLUCOMANNAN 
Synonyms  
Definition  Konjac glucomannan is a water-soluble hydrocolloid obtained from 
Konjac flour by washing with water-containing ethanol. Konjac flour 
is the unpurified raw product from the tuber of the perennial plant  
Amorphophallus konjac . The main component is the water-soluble 
high-molecular-weight polysaccharide glucomannan, which consists 
of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, 
connected by β(1-4)-glycosidic bonds with a branch at about each 
50th or 60th unit. About each 19th sugar residue is acetylated  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 146
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  500 000 to 2 000 000  
Assay  Total dietary fibre: not less than 95 % on a dry weight basis  
Description  White to slightly brownish fine particle size, free flowing and 
odourless powder  
Identification  
Solubility  Dispersible in hot or cold water forming a highly viscous solution 
with a pH between 5,0 and 7,0. Solubility is increased by heat and 
mechanical agitation  
Formation of heat-stable gel  Prepare a 2 % solution of the sample by heating it in a boiling water 
bath for 30 min, with continuous agitation and then cooling the 
solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium 
carbonate solution to the fully hydrated sample at ambient 
temperature. Heat the mixture in a water bath to 85 °C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
 
Purity  
Loss on drying  Not more than 8 % (105 °C, 3 hours)  
Starch  Not more than 1 %  
Viscosity (1 % solution)  Not less than 20 kgm  – 1 s – 1 at 25 °C  
Protein  Not more than 1,5 % (N × 5,7) 
Determine nitrogen by Kjeldahl method. The percentage of nitrogen 
in the sample multiplied by 5,7 gives the percent of protein in the sample
 
Ether-soluble material  Not more than 0,5 %  
Sulphite (as SO  2 ) Not more than 4 mg/kg  
Chloride  Not more than 0,02 %  
50 % Alcohol-soluble material  Not more than 2,0 %  
Total ash  Not more than 2,0 % (800 °C, 3 to 4 hours)  
Lead  Not more than 1 mg/kg  
Microbiological criteria  
Salmonella  spp.  Absent in 12,5 g  
Escherichia coli  Absent in 5 g  
E 426 SOYBEAN HEMICELLULOSE 
Synonyms  
Definition  Soybean Hemicellulose is a refined water-soluble polysaccharide 
obtained from strain soybean fibre by hot water extraction. No organic precipitant shall be used other than ethanol
 
Einecs  
Chemical name  Water soluble soybean polysaccharides; Water soluble soybean fibre  
Chemical formula  
Molecular weight  
Assay  Not less than 74 % carbohydrate  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 147
 
Description  Free flowing white or yellowish white powder  
Identification  
Solubility  Soluble in hot and cold water without gel formation  
pH 5,5 ± 1,5 (1% solution)  
Purity  
Loss on drying  Not more than 7 % (105 °C, 4 hours)  
Protein  Not more than 14 %  
Viscosity  Not more than 200 mPa.s (10 % solution)  
Total ash  Not more than 9,5 % (600 °C, 4 hours)  
Arsenic  Not more than 2 mg/kg  
Ethanol  Not more than 2%  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 3 000 colonies per gram  
Yeast and moulds  Not more than 100 colonies per gram  
Escherichia coli  Absent in 10 g  
E 427 CASSIA GUM 
Synonyms  
Definition  Cassia gum is the ground purified endosperm of the seeds of  Cassia 
tora and  Cassia obtusifoli  (Leguminosae ) containing less than 
0,05 % of  Cassia occidentalis . It consists mainly of high 
molecular weight polysaccharides composed primarily of a linear 
chain of 1,4- β-D-mannopyranose units linked with 1,6- α-D- 
galactopyranose units. The ratio of mannose to galactose is about 5:1. 
In the manufacture the seeds are dehusked and degermed by thermal 
mechanical treatment followed by milling and screening of the endosperm. The ground endosperm is further purified by extraction with propan-2-ol.
 
Assay  Not less than 75 % of Galactomannan  
Description  Pale yellow to off-white, odourless powder  
Identification  
Solubility  Insoluble in ethanol. Disperses well in cold water forming a colloidal 
solution.  
Gel formation with borate  To an aqueous dispersion of the sample add sufficient sodium borate 
test solution (TS) to raise the pH to above 9; a gel is formed.  
Gel formation with xanthan gum  Weigh 1,5 g of the sample and 1,5 g of xanthan gum and blend 
them. Add this blend (with rapid stirring) into 300 ml water at 80 °C in a 400 ml beaker. Stir until the mixture is dissolved and continue stirring for an extra 30 min after dissolution (maintain the 
temperature above 60 °C during the stirring process). Discontinue 
stirring and allow the mixture to cool at room temperature for at least 2 h.
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 148
 
A firm, viscoelastic gel forms after the temperature drops below 
40 °C, but no such gel forms in a 1 % control solution of cassia 
gum or xanthan gum alone prepared in a similar manner.  
Viscosity  Less than 500 mPa.s (25 °C, 2h, 1 % solution) corresponding to an 
average molecular weight of 200 000-300 000 Da  
Purity  
Acid insoluble matter  Not more than 2,0 %  
pH 5,5-8 (1 % aqueous solution)  
Crude fat  Not more than 1 %  
Protein  Not more than 7 %  
Total ash  Not more than 1,2 %  
Loss on drying  Not more than 12 % (5h, 105 °C)  
Total anthraquinones  Not more than 0,5 mg/kg(detection limit)  
Solvent residues  Not more than 750 mg/kg Propan-2-ol  
Lead  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 5 000 colony forming units per gram  
Yeast and moulds  Not more than 100 colony forming units per gram  
Salmonella  spp.  Absent in 25 g  
Escherichia coli  Absent in 1 g  
E 431 POLYOXYETHYLENE (40) STEARATE 
Synonyms  Polyoxyl (40) stearate; Polyoxyethylene (40) monostearate  
Definition  A mixture of the mono- and diesters of edible commercial stearic 
acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 97,5 % on the anhydrous basis  
Description  Cream-coloured flakes or waxy solid at 25 °C with a faint odour  
Identification  
Solubility  Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in 
mineral oil  
Congealing range  39-44 °C  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a polyoxyethylated 
polyol  
Purity  
Water content  Not more than 3 % (Karl Fischer method)  
Acid value  Not more than 1  
Saponification value  Not less than 25 and not more than 35  
Hydroxyl value  Not less than 27 and not more than 40  
1,4-Dioxane  Not more than 5 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 149
 
Ethylene oxide  Not more than 0,2 mg/kg  
Ethylene glycols (mono- and di-)  Not more than 0,25 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLY ­
SORBATE 20) 
Synonyms  Polysorbate 20; Polyoxyethylene (20) sorbitan monolaurate  
Definition  A mixture of the partial esters of sorbitol and its mono- and dian ­
hydrides with edible commercial lauric acid and condensed with 
approximately 20 moles of ethylene oxide per mole of sorbitol 
and its anhydrides  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 70 % of oxyethylene groups, equivalent to not 
less than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on 
the anhydrous basis  
Description  A lemon to amber-coloured oily liquid at 25 °C with a faint char ­
acteristic odour  
Identification  
Solubility  Soluble in water, ethanol, methanol, ethyl acetate and dioxane. 
Insoluble in mineral oil and petroleum ether  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a polyoxyethylated 
polyol  
Purity  
Water content  Not more than 3 % (Karl Fischer method)  
Acid value  Not more than 2  
Saponification value  Not less than 40 and not more than 50  
Hydroxyl value  Not less than 96 and not more than 108  
1,4-dioxane  Not more than 5 mg/kg  
Ethylene oxide  Not more than 0,2 mg/kg  
Ethylene glycols (mono- and di-)  Not more than 0,25 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLY ­
SORBATE 80) 
Synonyms  Polysorbate 80; Polyoxyethylene (20) sorbitan monooleate  
Definition  A mixture of the partial esters of sorbitol and its mono- and dian ­
hydrides with edible commercial oleic acid and condensed with 
approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 150
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 65 % of oxyethylene groups, equivalent to not 
less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis
 
Description  A lemon to amber-coloured oily liquid at 25 °C with a faint char ­
acteristic odour  
Identification  
Solubility  Soluble in water, ethanol, methanol, ethyl acetate and toluene. 
Insoluble in mineral oil and petroleum ether  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a polyoxyethylated 
polyol  
Purity  
Water content  Not more than 3 % (Karl Fischer method)  
Acid value  Not more than 2  
Saponification value  Not less than 45 and not more than 55  
Hydroxyl value  Not less than 65 and not more than 80  
1,4-dioxane  Not more than 5 mg/kg  
Ethylene oxide  Not more than 0,2 mg/kg  
Ethylene glycols (mono- and di-)  Not more than 0,25 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLY ­
SORBATE 40) 
Synonyms  Polysorbate 40; Polyoxyethylene (20) sorbitan monopalmitate  
Definition  A mixture of the partial esters of sorbitol and its mono- and dian ­
hydrides with edible commercial palmitic acid and condensed with 
approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 66 % of oxyethylene groups, equivalent to not 
less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basis
 
Description  A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a 
faint characteristic odour  
Identification  
Solubility  Soluble in water, ethanol, methanol, ethyl acetate and acetone. 
Insoluble in mineral oil  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 151
 
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a polyoxyethylated 
polyol  
Purity  
Water content  Not more than 3 % (Karl Fischer method)  
Acid value  Not more than 2  
Saponification value  Not less than 41 and not more than 52  
Hydroxyl value  Not less than 90 and not more than 107  
1,4-dioxane  Not more than 5 mg/kg  
Ethylene oxide  Not more than 0,2 mg/kg  
Ethylene glycols (mono- and di-)  Not more than 0,25 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLY ­
SORBATE 60) 
Synonyms  Polysorbate 60; Polyoxyethylene (20) sorbitan monostearate  
Definition  A mixture of the partial esters of sorbitol and its mono- and dian ­
hydrides with edible commercial stearic acid and condensed with 
approximately 20 moles of ethylene oxide per mole of sorbitol 
and its anhydrides  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 65 % of oxyethylene groups, equivalent to not 
less than 97 % of polyoxyethylene (20) sorbitan monostearate on the 
anhydrous basis  
Description  A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a 
faint characteristic odour  
Identification  
Solubility  Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil 
and vegetable oils  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a polyoxyethylated 
polyol  
Purity  
Water content  Not more than 3 % (Karl Fischer method)  
Acid value  Not more than 2  
Saponification value  Not less than 45 and not more than 55  
Hydroxyl value  Not less than 81 and not more than 96  
1,4-dioxane  Not more than 5 mg/kg  
Ethylene oxide  Not more than 0,2 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 152
 
Ethylene glycols (mono- and di-)  Not more than 0,25 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLY ­
SORBATE 65) 
Synonyms  Polysorbate 65; Polyoxyethylene (20) sorbitan tristearate  
Definition  A mixture of the partial esters of sorbitol and its mono- and dian ­
hydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 46 % of oxyethylene groups, equivalent to not 
less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis
 
Description  A tan-coloured, waxy solid at 25 °C with a faint characteristic odour  
Identification  
Solubility  Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum 
ether, acetone, ether, dioxane, ethanol and methanol  
Congealing range  29-33 °C  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a polyoxyethylated 
polyol  
Purity  
Water content  Not more than 3 % (Karl Fischer method)  
Acid value  Not more than 2  
Saponification value  Not less than 88 and not more than 98  
Hydroxyl value  Not less than 40 and not more than 60  
1,4-dioxane  Not more than 5 mg/kg  
Ethylene oxide  Not more than 0,2 mg/kg  
Ethylene glycols (mono- and di-)  Not more than 0,25 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 153
 
E 440 (i) PECTIN 
Synonyms  
Definition  Pectin consists mainly of the partial methyl esters of polygal ­
acturonic acid and their ammonium, sodium, potassium and 
calcium salts. It is obtained by extraction in an aqueous medium 
of strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propan-2-ol
 
Einecs  232-553-0  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 65 % of galacturonic acid on the ash-free and 
anhydrous basis after washing with acid and alcohol  
Description  White, light yellow, light grey or light brown powder  
Identification  
Solubility  Soluble in water forming a colloidal, opalescent solution. Insoluble 
in ethanol  
Purity  
Loss on drying  Not more than 12 % (105 °C, 2 hours)  
Acid insoluble ash  Not more than 1 % (insoluble in approximately 3N hydrochloric 
acid)  
Sulphur dioxide  Not more than 50 mg/kg on the anhydrous basis  
Nitrogen content  Not more than 1,0 % after washing with acid and ethanol  
Total insolubles  Not more than 3 %  
Solvent residues  Not more than 1 % of free methanol, ethanol and propan-2-ol, singly 
or in combination, on the volatile matter-free basis  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 440 (ii) AMIDATED PECTIN 
Synonyms  
Definition  Amidated pectin consists mainly of the partial methyl esters and 
amides of polygalacturonic acid and their ammonium, sodium, 
potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under 
alkaline conditions. No organic precipitant shall be used other than 
methanol, ethanol and propan-2-ol
 
Einecs  
Chemical name  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 154
 
Chemical formula  
Molecular weight  
Assay  Content not less than 65 % of galacturonic acid on the ash-free and 
anhydrous basis after washing with acid and alcohol  
Description  White, light yellow, light greyish or light brownish powder  
Identification  
Solubility  Soluble in water forming a colloidal, opalescent solution. Insoluble 
in ethanol  
Purity  
Loss on drying  Not more than 12 % (105 °C, 2 hours)  
Acid-insoluble ash  Not more than 1 % (insoluble in approximately 3N hydrochloric 
acid)  
Degree of amidation  Not more than 25 % of total carboxyl groups  
Sulphur dioxide residue  Not more than 50 mg/kg on the anhydrous basis  
Nitrogen content  Not more than 2,5 % after washing with acid and ethanol  
Total insolubles:  Not more than 3 %  
Solvent residues  Not more than 1 % of methanol, ethanol and propan-2-ol, singly or 
in combination, on a volatile matter-free basis  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 442 AMMONIUM PHOSPHATIDES 
Synonyms  Ammonium salts of phosphatidic acid; Mixed ammonium salts of 
phoshorylated glycerides  
Definition  A mixture of the ammonium compounds of phosphatidic acids 
derived from edible fat and oil. One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus 
esters may be linked together as phosphatidyl phosphatides
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  The phosphorus content is not less than 3 % and not more than 
3,4 % by weight; the ammonium content is not less than 1,2 % 
and not more than 1,5 % (calculated as N)  
▼M3 
Description  Unctuous semi-solid to oily liquid  
▼B 
Identification  
Solubility  Soluble in fats. Insoluble in water. Partially soluble in ethanol and in 
acetone  
Test for glycerol  Passes test  
Test fatty acids  Passes test  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 155
 
Test for phosphate  Passes test  
Purity  
Petroleum ether insoluble matter  Not more than 2,5 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 444 SUCROSE ACETATE ISOBUTYRATE 
Synonyms  SAIB  
Definition  Sucrose acetate isobutyrate is a mixture of the reaction products 
formed by the esterification of food grade sucrose with acetic acid 
anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6
 
Einecs  204-771-6  
Chemical name  Sucrose diacetate hexaisobutyrate  
Chemical formula  C  40 H 62 O 19 
Molecular weight  832-856 (approximate), C  40 H 62 O 19 : 846,9  
Assay  Content not less than 98,8 % and not more than 101,9 % of 
C 40 H 62 O 19 
Description  A pale straw-coloured liquid, clear and free of sediment and having 
a bland odour  
Identification  
Solubility  Insoluble in water. Soluble in most organic solvents  
Refractive index  [n]  D 40 : 1,4492-1,4504  
Specific gravity  [d]  25 D : 1,141-1,151  
Purity  
Triacetin  Not more than 0,1 %  
Acid value  Not more than 0,2  
Saponification value  Not less than 524 and not more than 540  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 445 GLYCEROL ESTERS OF WOOD ROSIN 
Synonyms  Ester gum  
Definition  A complex mixture of tri- and diglycerol esters of resin acids from 
wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. 
Excluded from these specifications are substances derived from 
gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper)
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 156
 
pulp processing. The final product is composed of approximately 
90 % resin acids and 10 % neutrals (non-acidic compounds). The 
resin acid fraction is a complex mixture of isomeric diterpenoid 
monocarboxylic acids having the empirical molecular formula of C
 20 H 30 O 2 , chiefly abietic acid. The substance is purified by steam 
stripping or by countercurrent steam distillation  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Hard, yellow to pale amber-coloured solid  
Identification  
Solubility  Insoluble in water, soluble in acetone  
Infrared absorption spectrum  Characteristic of the compound  
Purity  
Specific gravity of solution  [d]  20 25 not less than 0,935 when determined in a 50 % solution in d- 
limonene (97 %, boiling point 175,5-176 °C, d  20 4 : 0,84)  
Ring and ball softening range  Between 82 °C and 90 °C  
Acid value  Not less than 3 and not more than 9  
Hydroxyl value  Not less than 15 and not more than 45  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Test for absence of tall oil rosin (sulphur 
test) When sulphur-containing organic compounds are heated in the 
presence of sodium formate, the sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of 
wood rosin
 
E 450 (i) DISODIUM DIPHOSPHATE 
Synonyms  Disodium dihydrogen diphosphate; Disodium dihydrogen pyrophos ­
phate; Sodium acid pyrophosphate; Disodium pyrophosphate  
Definition  
Einecs  231-835-0  
Chemical name  Disodium dihydrogen diphosphate  
Chemical formula  Na  2 H 2 P 2 O 7 
Molecular weight  221,94  
Assay  Content not less than 95 % of disodium diphosphate 
P 2 O 5 content not less than 63,0 % and not more than 64,5 %  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 157
 
Description  White powder or grains  
Identification  
Test for sodium  Passes test  
Test for phosphate  Passes test  
Solubility  Soluble in water  
pH Between 3,7 and 5,0 (1 % solution)  
Purity  
Loss on drying  Not more than 0,5 % (105 °C, 4 hours)  
Water insoluble matter  Not more than 1 %  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Aluminium  Not more than 200 mg/kg  
E 450 (ii) TRISODIUM DIPHOSPHATE 
Synonyms  Trisodium pyrophosphate; Trisodium monohydrogen diphosphate; 
Trisodium monohydrogen pyrophosphate; Trisodium diphosphate  
Definition  
Einecs  238-735-6  
Chemical name  
Chemical formula  Monohydrate: Na  3 HP 2 O 7 · H 2 O 
Anhydrous: Na  3 HP 2 O 7 
Molecular weight  Monohydrate: 261,95 
Anhydrous: 243,93  
Assay  Content not less than 95 % on the dried basis 
P 2 O 5 content not less than 57 % and not more than 59 %  
Description  White powder or grains, occurs anhydrous or as a monohydrate  
Identification  
Test for sodium  Passes test  
Test for phosphate  Passes test  
Solubility  Soluble in water  
pH Between 6,7 and 7,5 (1 % solution)  
Purity  
Loss on ignition  Not more than 4,5 % on the anhydrous compound (450-550 °C). 
Not more than 11,5 % on the monohydrate basis  
Loss on drying  Not more than 0,5 % (105 °C, 4 hours) for anhydrous 
Not more than 1,0 % (105 °C, 4 hours) for monohdyrate  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 158
 
Water insoluble matter  Not more than 0,2 %  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 450 (iii) TETRASODIUM DIPHOSPHATE 
Synonyms  Tetrasodium pyrophosphate; Tetrasodium disphosphate; Tetrasodium 
phosphate  
Definition  
Einecs  231-767-1  
Chemical name  Tetrasodium diphosphate  
Chemical formula  Anhydrous: Na  4 P 2 O 7 
Decahydrate: Na  4 P 2 O 7 · 10H  2 O 
Molecular weight  Anhydrous: 265,94 
Decahydrate: 446,09  
Assay  Content not less than 95 % of Na  4 P 2 O 7 on the ignited basis 
P 2 O 5 content not less than 52,5 % and not more than 54,0 %  
Description  Colourless or white crystals, or a white crystalline or granular 
powder. The decahydrate effloresces slightly in dry air  
Identification  
Test for sodium  Passes test  
Test for phosphate  Passes test  
Solubility  Soluble in water. Insoluble in ethanol  
pH Between 9,8 and 10,8 (1 % solution)  
Purity  
Loss on ignition  Not more than 0,5 % for the anhydrous salt, not less than 38 % and 
not more than 42 % for the decahydrate (105 °C, 4 hours then 
550 °C, 30 minutes)  
Water insoluble matter  Not more than 0,2 %  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1mg/kg  
Mercury  Not more than 1 mg/kg  
E 450 (v) TETRAPOTASSIUM DIPHOSPHATE 
Synonyms  Tetrapotassium pyrophosphate  
Definition  
Einecs  230-785-7  
Chemical name  Tetrapotassium diphosphate  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 159
 
Chemical formula  K  4 P 2 O 7 
Molecular weight  330,34 (anhydrous)  
Assay  Content not less than 95 % (800 °C for 0,5 hours) 
P 2 O 5 content not less than 42,0 % and not more than 43,7 % on the 
anhydrous basis  
Description  Colourless crystals or white, very hygroscopic powder  
Identification  
Test for potassium  Passes test  
Test for phosphate  Passes test  
Solubility  Soluble in water, insoluble in ethanol  
pH Between 10,0 and 10,8 (1 % solution)  
Purity  
Loss on ignition  Not more than 2 % (105 °C, 4 hours then 550 °C, 30 minutes)  
Water insoluble matter  Not more than 0,2 %  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 450 (vi) DICALCIUM DIPHOSPHATE 
Synonyms  Calcium pyrophosphate  
Definition  
Einecs  232-221-5  
Chemical name  Dicalcium diphosphate 
Dicalcium pyrophosphate  
Chemical formula  Ca  2 P 2 O 7 
Molecular weight  254,12  
Assay  Content not less than 96 % 
P 2 O 5 content not less than 55 % and not more than 56 %  
Description  A fine, white, odourless powder  
Identification  
Test for calcium  Passes test  
Test for phosphate  Passes test  
Solubility  Insoluble in water. Soluble in dilute hydrochloric and nitric acids  
pH Between 5,5 and 7,0 (10 % suspension in water)  
Purity  
Loss on ignition  Not more than 1,5 % (800 °C ± 25 °C, 30 minutes  
Fluoride  Not more than 50 mg/kg (expressed as fluorine)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 160
 
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE 
Synonyms  Acid calcium pyrophosphate; Monocalcium dihydrogen pyrophos ­
phate  
Definition  
Einecs  238-933-2  
Chemical name  Calcium dihydrogen diphosphate  
Chemical formula  CaH  2 P 2 O 7 
Molecular weight  215,97  
Assay  Content not less than 90 % on the anhydrous basis 
P 2 O 5 content not less than 61 % and not more than 66 %  
Description  White crystals or powder  
Identification  
Test for calcium  Passes test  
Test for phosphate  Passes test  
Purity  
Acid-insoluble matter  Not more than 0,4 %  
Fluoride  Not more than 30 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Aluminium  Not more than 800 mg/kg. This applies until 31 March 2015. 
Not more than 200 mg/kg. This applies from 1 April 2015.  
▼M10  
E 450 (ix) MAGNESIUM DIHYDROGEN DIPHOSPHATE 
Synonyms  Acid magnesium pyrophosphate, monomagnesium dihydrogen 
pyrophosphate; magnesium diphosphate, magnesium pyrophosphate  
Definition  Magnesium dihydrogen diphosphate is the acidic magnesium salt of 
diphosphoric acid. It is manufactured by adding an aqueous dispersion of magnesium hydroxide slowly to phosphoric acid, until a molar ratio about 1:2 between Mg and P is reached. The 
temperature is held under 60 °C during the reaction. About 0,1 % 
hydrogen peroxide is added to the reaction mixture and the slurry is then heated and milled.
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 161
 
EINECS  244-016-8  
Chemical name  Mono magnesium dihydrogen diphosphate  
Chemical formula  MgH  2 P 2 O 7 
Molecular Weight  200,25  
Assay  P  2 O 5 content not less than 68,0 % and not more than 70,5 % 
expressed as P  2 O 5 
MgO content not less than 18,0 % and not more than 20,5 % 
expressed as MgO  
Description  White crystals or powder  
Identification  
Solubility  Slightly soluble in water, practically insoluble in ethanol  
Particle size:  The average particle size will deviate between 10 and 50 μm 
Purity  
Loss on ignition  Not more than 12 % (800 °C, 0,5 hours)  
Fluoride  Not more than 20 mg/kg (expressed as fluorine)  
Aluminium  Not more than 50 mg/kg  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg.  
Lead  Not more than 1 mg/kg  
▼B 
E 451 (i) PENTASODIUM TRIPHOSPHATE 
Synonyms  Pentasodium tripolyphosphate; Sodium tripolyphosphate  
Definition  
Einecs  231-838-7  
Chemical name  Pentasodium triphosphate  
Chemical formula  Na  5 O 10 P 3 · nH  2 O (n = 0 or 6)  
Molecular weight  367,86  
Assay  Content not less than 85,0 % (anhydrous) or 65,0 % (hexahydrate) 
P 2 O 5 content not less than 56 % and not more than 59 % 
(anhydrous) or not less than 43 % and not more than 45 % (hex ­
ahydrate)  ▼M10  2012R0231 — EN — 11.07.2014 — 008.001 — 162
 
Description  White, slightly hygroscopic granules or powder  
Identification  
Solubility  Freely soluble in water. Insoluble in ethanol  
Test for sodium  Passes test  
Test for phosphate  Passes test  
pH Between 9,1 and 10,2 (1 % solution)  
Purity  
Loss on drying  Anhydrous: Not more than 0,7 % (105 °C, 1 hour) 
Hexahydrate: Not more than 23,5 % (60 °C, 1 hour, then 105 °C, 4 
hours)  
Water insoluble matter  Not more than 0,1 %  
Higher polyphosphates  Not more than 1 %  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE 
Synonyms  Pentapotassium tripolyphosphate; Potassium triphosphate; Potassium 
tripolyphosphate  
Definition  
Einecs  237-574-9  
Chemical name  Pentapotassium triphosphate; Pentapotassium tripolyphosphate  
Chemical formula  K  5 O 10 P 3 
Molecular weight  448,42  
Assay  Content not less than 85 % on the anhydrous basis 
P 2 O 5 content not less than 46,5 % and not more than 48 %  
Description  White, very hygroscopic powder or granules  
Identification  
Solubility  Very soluble in water  
Test for potassium  Passes test  
Test for phosphate  Passes test  
pH Between 9,2 and 10,5 (1 % solution)  
Purity  
Loss on ignition  Not more than 0,4 % (105 °C, 4 hours, then 550 °C, 30 minutes)  
Water insoluble matter  Not more than 2 %  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 163
 
Mercury  Not more than 1 mg/kg  
E 452 (i) SODIUM POLYPHOSPHATE  
I. SOLUBLE POLYPHOSPHATE 
Synonyms  Sodium hexametaphosphate; Sodium tetrapolyphosphate; Graham's 
salt; Sodium polyphosphates, glassy; Sodium polymetaphosphate; Sodium metaphosphate
 
Definition  Soluble sodium polyphosphates are obtained by fusion and 
subsequent chilling of sodium orthophosphates. These compounds 
are a class consisting of several amorphous, water-soluble polyphos ­
phates composed of linear chains of metaphosphate units, (NaPO  3 ) x 
where x ≥ 2, terminated by Na  2 PO 4 groups. These substances are 
usually identified by their Na  2 O/P  2 O 5 ratio or their P  2 O 5 content. 
The Na  2 O/P  2 O 5 ratios vary from about 1,3 for sodium tetrapolyphos ­
phate, where x = approximately 4; to about 1,1 for Graham's salt, commonly called sodium hexametaphosphate, where x = 13 to 18; 
and to about 1,0 for the higher molecular weight sodium polyphos ­
phates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0
 
Einecs  272-808-3  
Chemical name  Sodium polyphosphate  
Chemical formula  Heterogenous mixtures of sodium salts of linear condensed poly ­
phosphoric acids of general formula H  (n + 2)  P n O (3n + 1)  where ‘n’ 
is not less than 2  
Molecular weight  (102)  n 
Assay  P  2 O 5 content not less than 60 % and not more than 71 % on the 
ignited basis  
Description  Colourless or white, transparent platelets, granules, or powders  
Identification  
Solubility  Very soluble in water  
Test for sodium  Passes test  
Test for phosphate  Passes test  
pH Between 3,0 and 9,0 (1 % solution)  
Purity  
Loss on ignition  Not more than 1 %  
Water insoluble matter  Not more than 0,1 %  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
II. INSOLUBLE POLYPHOSPHATE 
Synonyms  Insoluble sodium metaphosphate; Maddrell's salt; Insoluble sodium 
polyphosphate; IMP  
Definition  Insoluble sodium metaphosphate is a high molecular weight sodium 
polyphosphate composed of two long metaphosphate chains 
(NaPO  3 ) x that spiral in opposite directions about a common axis. 
The Na  2 O/P  2 O 5 ratio is about 1,0. The pH of 1 in 3 suspension in 
water is about 6,5  
Einecs  272-808-3  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 164
 
Chemical name  Sodium polyphosphate  
Chemical formula  Heterogenous mixtures of sodium salts of linear condensed poly ­
phosphoric acids of general formula H  (n + 2)  P n O (3n + 1)  where ‘n’ 
is not less than 2  
Molecular weight  (102)  n 
Assay  P  2 O 5 content not less than 68,7 % and not more than 70,0 %  
Description  White crystalline powder  
Identification  
Solubility  Insoluble in water, soluble in mineral acids and in solutions of 
potassium and ammonium (but not sodium) chlorides  
Test for sodium  Passes test  
Test for phosphate  Passes test  
pH About 6,5 (1 in 3 suspension in water)  
Purity  
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 452 (ii) POTASSIUM POLYPHOSPHATE 
Synonyms  Potassium metaphosphate; Potassium polymetaphosphate; Kurrol salt  
Definition  
Einecs  232-212-6  
Chemical name  Potassium polyphosphate  
Chemical formula  (KPO  3 )n 
Heterogenous mixtures of potassium salts of linear condensed poly ­
phosphoric acids of general formula H  (n + 2)  P n O (3n + 1)  where ‘n’ is 
not less than 2  
Molecular weight  (118)  n 
Assay  P  2 O 5 content not less than 53,5 % and not more than 61,5 % on the 
ignited basis  
Description  Fine white powder or crystals or colourless glassy platelets  
Identification  
Solubility  1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate  
Test for potassium  Passes test  
Test for phosphate  Passes test  
pH Not more than 7,8 (1 % suspension)  
Purity  
Loss on ignition  Not more than 2 % (105 °C, 4 hours then 550 °C, 30 minutes)  
Cyclic phosphate  Not more than 8 % on P  2 O 5 content  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 165
 
Fluoride  Not more than 10 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 452(iii) SODIUM CALCIUM POLYPHOSPHATE 
Synonyms  Sodium calcium polyphosphate, glassy  
Definition  
Einecs  233-782-9  
Chemical name  Sodium calcium polyphosphate  
Chemical formula  (NaPO  3 ) n CaO where n is typically 5  
Molecular weight  
Assay  P  2 O 5 content not less than 61 % and not more than 69 % on the 
ignited basis  
Description  White glassy crystals, spheres  
Identification  
pH Approximately 5 to 7 (1 % m/m slurry)  
CaO content  7 % - 15 % m/m  
Purity  
Fluoride  Not more than 10 mg/kg  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 452 (iv) CALCIUM POLYPHOSPHATE 
Synonyms  Calcium metaphosphate; Calcium polymetaphosphate  
Definition  
Einecs  236-769-6  
Chemical name  Calcium polyphosphate  
Chemical formula  (CaP  2 O 6 )n 
Heterogenous mixtures of calcium salts of condensed polyphos ­
phoric acids of general formula H  (n + 2)  P n O (n + 1)  where ‘n’ is not 
less than 2  
Molecular weight  (198)  n 
Assay  P  2 O 5 content not less than 71 % and not more than 73 % on the 
ignited basis  
Description  Odourless, colourless crystals or white powder  
Identification  
Solubility  Usually sparingly soluble in water. Soluble in acid medium  
Test for calcium  Passes test  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 166
 
Test for phosphate  Passes test  
CaO content  27 to 29,5 %  
Purity  
Loss on ignition  Not more than 2 % (105 °C, 4 hours then 550 °C, 30 minutes)  
Cyclic phosphate  Not more than 8 % (on P  2 O 5 content)  
Fluoride  Not more than 30 mg/kg (expressed as fluorine)  
Arsenic  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 459 BETA-CYCLODEXTRIN 
Synonyms  
Definition  Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of 
seven α-1,4-linked D-glucopyranosyl units. The product is manu ­
factured by the action of the enzyme cycloglycosyltransferase 
(CGTase) obtained from  Bacillus circulans, Paenibacillus 
macerans  or recombinant  Bacillus licheniformis  strain SJ1608 on 
partially hydrolysed starch  
Einecs  231-493-2  
Chemical name  Cycloheptaamylose  
Chemical formula  (C  6 H 10 O 5 ) 7 
Molecular weight  1 135  
Assay  Content not less than 98,0 % of (C  6 H 10 O 5 ) 7 on an anhydrous basis  
Description  Virtually odourless white or almost white crystalline solid  
Appearance of the aqueous solution  Clear and colourless  
Identification  
Solubility  Sparingly soluble in water; freely soluble in hot water; slightly 
soluble in ethanol  
Specific rotation  [ α] D 25 + 160° to + 164° (1 % solution)  
pH value:  5,0-8,0 (1 % solution)  
Purity  
Water content  Not more than 14 % (Karl Fischer method)  
Other cyclodextrins  Not more than 2 % on an anhydrous basis  
Solvent residues  Not more than 1 mg/kg of each of toluene and trichloroethylene  
Sulphated ash  Not more than 0,1 %  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
▼M8 
E 460 (i) MICROCRYSTALLINE CELLULOSE, CELLULOSE GEL  
Synonyms  
▼B 
Definition  Microcrystalline cellulose is purified, partially depolymerised 
cellulose prepared by treating alpha-cellulose, obtained as a pulp 
from strains of fibrous plant material, with mineral acids. The 
degree of polymerisation is typically less than 400  
Einecs  232-674-9  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 167
 
Chemical name  Cellulose  
Chemical formula  (C  6 H 10 O 5 ) n 
Molecular weight  About 36 000  
Assay  Not less than 97 % calculated as cellulose on the anhydrous basis  
Particle size  Not less than 5  μm (not more than 10 % of particles of less than 
5 μm) 
Description  A fine white or almost white odourless powder  
Identification  
Solubility  Insoluble in water, ethanol, ether and dilute mineral acids. Slightly 
soluble in sodium hydroxide solution  
Colour reaction  To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a 
water bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyro ­
catechol in phosphoric acid and heat for 30 minutes. A red colour is 
produced  
Infrared absorption spectroscopy  To be identified  
Suspension test  Mix 30 g of the sample with 270 ml of water in a high-speed 
(12 000 rpm) power blender for 5 minutes. The resultant mixture 
will be either a free-following suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is 
obtained, transfer 100 ml into a 100-ml graduated cylinder and allow 
to stand for 1 hour. The solids settles and a supernatant liquid appears
 
pH The pH of the supernatant liquid is between 5,0 and 7,5 (10 % 
suspension in water)  
Purity  
Loss on drying  Not more than 7 % (105 °C, 3 hours)  
Water soluble matter  Not more than 0,24 %  
Sulphated ash  Not more than 0,5 % (800 ± 25 °C)  
Starch  Not detectable 
To 20 ml of the dispersion obtained in Identification, suspension 
test, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
 
Carboxyl groups  Not more than 1 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 460 (ii) POWDERED CELLULOSE 
Definition  Purified, mechanically disintegrated cellulose prepared by processing 
alpha-cellulose obtained as a pulp from strains of fibrous plant materials
 
Einecs  232-674-9  
Chemical name  Cellulose; Linear polymer of 1:4 linked glucose residues  
Chemical formula  (C  6 H 10 O 5 ) n 
Molecular weight  (162)  n (n is predominantly 1 000 and greater)  
Assay  Content not less than 92 %  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 168
 
Particle size  Not less than 5  μm (not more than 10 % of particles of less than 5  
μm) 
Description  A white, odourless powder  
Identification  
Solubility  Insoluble in water, ethanol, ether and dilute mineral acids. Slightly 
soluble in sodium hydroxide solution  
Suspension test  Mix 30 g of the sample with 270 ml of water in a high-speed 
(12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-flowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and 
contains many trapped air bubbles. If a free-flowing suspension is 
obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears
 
pH The pH of the supernatant liquid is between 5,0 and 7,5 (10 % 
suspension in water)  
Purity  
Loss on drying  Not more than 7 % (105 °C, 3 hours)  
Water soluble matter  Not more than 1,0 %  
Sulphated ash  Not more than 0,3 % (800 ± 25 °C)  
Starch  Not detectable 
To 20 ml of the dispersion obtained in Identification, suspension 
test, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 461 METHYL CELLULOSE 
Synonyms  Cellulose methyl ether  
Definition  Methyl cellulose is cellulose obtained directly from strains of fibrous 
plant material and partially etherified with methyl groups  
Einecs  
Chemical name  Methyl ether of cellulose  
Chemical formula  The polymers contain substituted anhydroglucose units with the 
following general formula: 
C 6 H 7 O 2 (OR  1 )(OR  2 )(OR  3 ) where R  1 , R 2 , R 3 each may be one of the 
following: 
— H 
— CH  3 or 
— CH  2 CH 3 
Molecular weight  From about 20 000 to 380 000  
Assay  Content not less than 25 % and not more than 33 % of methoxyl 
groups (-OCH  3 ) and not more than 5 % of hydroxyethoxyl groups 
(-OCH  2 CH 2 OH) ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 169
 
Description  Slightly hygroscopic white or slightly yellowish or greyish odourless 
and tasteless, granular or fibrous powder  
Identification  
Solubility  Swelling in water, producing a clear to opalescent, viscous, colloidal 
solution. 
Insoluble in ethanol, ether and chloroform. 
Soluble in glacial acetic acid  
pH Not less than 5,0 and not more than 8,0 (1 % colloidal solution)  
Purity  
Loss on drying  Not more than 10 % (105 °C, 3 hours)  
Sulphated ash  Not more than 1,5 % (800 ± 25 °C)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 462 ETHYL CELLULOSE 
Synonyms  Cellulose ethyl ether  
Definition  Ethyl cellulose is cellulose obtained directly from fibrous plant 
material and partially etherified with ethyl groups  
Einecs  
Chemical name  Ethyl ether of cellulose  
Chemical formula  The polymers contain substituted anhydroglucose units with the 
following general formula: 
C 6 H 7 O 2 (OR  1 )(OR  2 ) where R  1 and R  2 may be any of the following: 
— H 
— CH  2 CH 3 
Molecular weight  
Assay  Content not less than 44 % and not more than 50 % of ethoxyl 
groups (-OC  2 H 5 ) on the dried basis (equivalent to not more than 2,6 
ethoxyl groups per anhydroglucose unit)  
Description  Slightly hygroscopic white to off-white, odourless and tasteless 
powder  
Identification  
Solubility  Practically insoluble in water, in glycerol and in propane-1,2-diol but 
soluble in varying proportions in certain organic solvents depending 
upon the ethoxyl content. Ethyl cellulose containing less than 46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydrocarbon ethanol 
mixtures. Ethyl cellulose containing 46 to 48 % or more of ethoxyl 
groups is freely soluble in ethanol, in methanol, in toluene, in chloroform and in ethyl acetate
 
Film forming test  Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of 
toluene ethanol. A clear, stable, slightly yellow solution is formed. 
Pour a few ml of the solution onto a glass plate and allow the 
solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 170
 
pH Neutral to litmus (1 % colloidal solution)  
Purity  
Loss on drying  Not more than 3 % (105 °C, 2 hours)  
Sulphated ash  Not more than 0,4 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 463 HYDROXYPROPYL CELLULOSE 
Synonyms  Cellulose hydroxypropyl ether  
Definition  Hydroxypropylcellulose is cellulose obtained directly from strains of 
fibrous plant material and partially etherified with hydroxypropyl 
groups  
Einecs  
Chemical name  Hydroxypropyl ether of cellulose  
Chemical formula  The polymers contain substituted anhydroglucose units with the 
following general formula: 
C 6 H 7 O 2 (OR  1 )(OR  2 )(OR  3 ), where R  1 , R 2 , R 3 each may be one of the 
following: 
— H 
— CH  2 CHOHCH  3 
— CH  2 CHO(CH  2 CHOHCH  3 )CH  3 
— CH  2 CHO[CH  2 CHO(CH  2 CHOHCH  3 )CH  3 ]CH  3 
Molecular weight  From about 30 000 to 1 000 000  
Assay  Content not more than 80,5 % of hydroxypropoxyl groups 
(-OCH  2 CHOHCH  3 ) equivalent to not more than 4,6 hydroxypropyl 
groups per anhydroglucose unit on the anhydrous basis  
Description  Slightly hygroscopic white or slightly yellowish or greyish odourless 
and tasteless, granular or fibrous powder  
Identification  
Solubility  Swelling in water, producing a clear to opalescent, viscous, colloidal 
solution. Soluble in ethanol. Insoluble in ether  
Gas chromatography  Determine the substituents by gas chromotography  
pH Not less than 5,0 and not more than 8,0 (1 % colloidal solution)  
Purity  
Loss on drying  Not more than 10 % (105 °C, 3 hours)  
Sulphated ash  Not more than 0,5 % determined at 800 ± 25 °C  
Propylene chlorohydrins  Not more than 0,1 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 171
 
E 464 HYDROXYPROPYL METHYL CELLULOSE 
Synonyms  
Definition  Hydroxypropyl methyl cellulose is cellulose obtained directly from 
strains of fibrous plant material and partially etherified with methyl 
groups and containing a small degree of hydroxypropyl substitution  
Einecs  
Chemical name  2-Hydroxypropyl ether of methylcellulose  
Chemical formula  The polymers contain substituted anhydroglucose units with the 
following general formula: 
C 6 H 7 O 2 (OR  1 )(OR  2 )(OR  3 ), where R  1 , R 2 , R 3 each may be one of the 
following: 
— H 
— CH  3 
— CH  2 CHOHCH  3 
— CH  2 CHO (CH  2 CHOHCH  3 ) CH  3 
— CH  2 CHO[CH  2 CHO (CH  2 CHOHCH  3 ) CH  3 ]CH  3 
Molecular weight  From about 13 000 to 200 000  
Assay  Content not less than 19 % and not more than 30 % methoxyl 
groups (-OCH  3 ) and not less than 3 % and not more than 12 % 
hydroxypropoxyl groups (-OCH  2 CHOHCH  3 ), on the anhydrous 
basis  
Description  Slightly hygroscopic white or slightly yellowish or greyish odourless 
and tasteless, granular or fibrous powder  
Identification  
Solubility  Swelling in water, producing a clear to opalescent, viscous, colloidal 
solution. Insoluble in ethanol  
Gas chromatography  Determine the substituents by gas chromatography  
pH Not less than 5,0 and not more than 8,0 (1 % colloidal solution)  
Purity  
Loss on drying  Not more than 10 % (105 °C, 3 hours)  
Sulphated ash  Not more than 1,5 % for products with viscosities of 50 mPa.s or 
above 
Not more than 3 % for products with viscosities below 50 mPa.s  
Propylene chlorohydrins  Not more than 0,1 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 465 ETHYL METHYL CELLULOSE 
Synonyms  Methylethylcellulose  
Definition  Ethyl methyl cellulose is cellulose obtained directly from strains of 
fibrous plant material and partially etherified with methyl and ethyl 
groups  
Einecs  
Chemical name  Ethyl methyl ether of cellulose  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 172
 
Chemical formula  The polymers contain substituted anhydroglucose units with the 
following general formula: 
C 6 H 7 O 2 (OR  1 )(OR  2 )(OR  3 ), where R  1 , R 2 , R 3 each may be one of the 
following: 
— H 
— CH  3 
— CH  2 CH 3 
Molecular weight  From about 30 000 to 40 000  
Assay  Content on the anhydrous basis not less than 3,5 % and not more 
than 6,5 % of methoxyl groups (-OCH  3 ) and not less than 14,5 % 
and not more than 19 % of ethoxyl groups (-OCH  2 CH 3 ), and not 
less than 13,2 % and not more than 19,6 % of total alkoxyl groups, 
calculated as methoxyl  
Description  Slightly hygroscopic white or slightly yellowish or greyish odourless 
and tasteless, granular or fibrous powder  
Identification  
Solubility  Swelling in water, producing a clear to opalescent, viscous, colloidal 
solution. Soluble in ethanol. Insoluble in ether  
pH Not less than 5,0 and not more than 8,0 (1 % colloidal solution)  
Purity  
Loss on drying  Not more than 15 % for the fibrous form, and not more than 10 % 
for the powdered form (105 °C to constant weight)  
Sulphated ash  Not more than 0,6 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
▼M8 
E 466 SODIUM CARBOXY METHYL CELLULOSE, CELLULOSE GUM  
Synonyms  NaCMC; Sodium CMC  
Definition  Sodium carboxy methyl cellulose is the partial sodium salt of a 
carboxymethyl ether of cellulose, the cellulose being obtained 
directly from strains of fibrous plant material  
▼B 
Einecs  
Chemical name  Sodium salt of the carboxymethyl ether of cellulose  
Chemical formula  The polymers contain substituted anhydroglucose units with the 
following general formula: 
C 6 H 7 O 2 (OR  1 )(OR  2 )(OR  3 ), where R  1 , R 2 , R 3 each may be one of the 
following: 
— H 
— CH  2 COONa 
— CH  2 COOH  
Molecular weight  Higher than approximately 17 000 (degree of polymerisation 
approximately 100)  
Assay  Content on the anhydrous basis not less than 99,5 %  
Description  Slightly hygroscopic white or slightly yellowish or greyish odourless 
and tasteless, granular or fibrous powder  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 173
 
Identification  
Solubility  Yields a viscous colloidal solution with water. Insoluble in ethanol  
Foam test  A 0,1 % solution of the sample is shaken vigorously. No layer of 
foam appears. (This test permits the distinction of sodium carboxy ­
methyl cellulose from other cellulose ethers)  
Precipitate formation  To 5 ml of a 0,5 % solution of the sample, add 5 ml of 5 % solution 
of copper sulphate or of aluminium sulphate. A precipitate appears. 
(This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth)
 
Colour reaction  Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of 
water, while stirring to produce an uniform dispersion. Continue the 
stirring until a clear solution is produced, and use the solution for the 
following test: 
To 1 mg of the sample, diluted with an equal volume of water, in a 
small test tube, add 5 drops of 1-naphthol solution. Incline the test 
tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
 
pH Not less than 5,0 and not more than 8,5 (1 % colloidal solution)  
Purity  
Degree of substitution  Not less than 0,2 and not more than 1,5 carboxymethyl groups 
(-CH  2 COOH) per anhydroglucose unit  
Loss on drying  Not more than 12 % (105 °C to constant weight)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Total glycolate  Not more than 0,4 %, calculated as sodium glycolate on the 
anhydrous basis  
Sodium  Not more than 12,4 % on the anhydrous basis  
E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE, 
CROSS-LINKED CELLULOSE GUM 
Synonyms  Cross-linked carboxymethyl cellulose; Cross-linked CMC; Cross- 
linked sodium CMC;  
Definition  Cross-linked sodium carboxymethyl cellulose is the sodium salt of 
thermally cross-linked partly O-carboxymethylated cellulose  
Einecs  
Chemical name  Sodium salt of the cross-linked carboxymethyl ether cellulose  
Chemical formula  The polymers containing substituted anhydroglucose units with the 
general formula: 
C 6 H 7 O 2 (OR  1 )(OR  2 )(OR  3 ) where R  1 , R 2 and R  3 may be any of the 
following: 
— H 
— CH  2 COONa 
— CH  2 COOH  
Molecular weight  
Assay  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 174
 
Description  Slightly hygroscopic, white to off white, odourless powder  
Identification  
Precipitate formation  Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene 
blue and allow to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass
 
Colour reaction  Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test 
tube, add 1 ml water and 0,05 ml of freshly prepared 40 g/l solution 
of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of sulphuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface
 
Test for sodium  Passes test  
pH Not less than 5,0 and not more than 7,0 (1 % solution)  
Purity  
Loss on drying  Not more than 6 % (105 °C, 3 hours)  
Water soluble matter  Not more than 10 %  
Degree of substitution  Not less than 0,2 and not more than 1,5 carboxymethyl groups per 
anhydroglucose unit  
Sodium content  Not more than 12,4 % on anhydrous basis  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Cadmium  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCEL ­
LULOSE, ENZYMATICALLY HYDROLISED CELLULOSE GUM 
Synonyms  Sodium carboxymethyl cellulose, enzymatically hydrolysed  
Definition  Enzymatically hydrolysed carboxymethylcellulose is obtained from 
carboxymethylcellulose by enzymatic digestion with a cellulase produced by  Trichoderma longibrachiatum  (formerly  T. reesei )
 
Einecs  
Chemical name  Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed  
Chemical formula  Sodium salts of polymers containing substituted anhydroglucose 
units with the general formula: 
[C 6 H 7 O 2 (OH)  x (OCH  2 COONa)  y ] n 
where n is the degree of polymerisation 
x = 1,50 to 2,80 
y = 0,2 to 1,50 
x + y = 3,0 
(y = degree of substitution)  
Molecular weight  178,14 where y = 0,20 
282,18 where y = 1,50 
Macromolecules: Not less than 800 (n about 4)  
Assay  Not less than 99,5 %, including mono- and disaccharides, on the 
dried basis  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 175
 
Description  White or slightly yellowish or greyish, odourless, slightly hygro ­
scopic granular or fibrous powder  
Identification  
Solubility  Soluble in water, insoluble in ethanol  
Foam test  Vigorously shake a 0,1 % solution of the sample. No layer of foam 
appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and natural gums
 
Precipitate formation  To 5 ml of a 0,5 % solution of the sample add 5 ml of a 5 % 
solution of copper or aluminium sulphate. A precipitate appears. 
This test distinguishes sodium carboxymethyl cellulose, whether 
hydrolysed or not, from other cellulose ethers and from gelatine, carob bean gum and tragacanth gum
 
Colour reaction  Add 0,5 g of the powdered sample to 50 ml of water, while stirring 
to produce a uniform dispersion. Continue the stirring until a clear solution is produced. Dilute 1 ml of the solution with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, 
and carefully introduce down the side of the tube 2 ml of sulphuric 
acid so that it forms a lower layer. A red-purple colour develops at the interface
 
Viscosity (60 % solids)  Not less than 2 500 kgm  – 1 s – 1 at 25 °C corresponding to an average 
molecule weight of 5 000 Da  
pH Not less than 6,0 and not more than 8,5 (1 % colloidal solution)  
Purity  
Loss on drying  Not more than 12 % (105 °C to constant weight)  
Degree of substitution  Not less than 0,2 and not more than 1,5 carboxymethyl groups per 
anhydroglucose unit on the dried basis  
Sodium chloride and sodium glycolate  Not more than 0,5 % singly or in combination  
Residual enzyme activity  Passes test. No change in viscosity of test solution occurs, which 
indicates hydrolysis of the sodium carboxymethyl cellulose  
Lead  Not more than 3 mg/kg  
E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY 
ACIDS 
Synonyms  
Definition  Sodium, potassium and calcium salts of fatty acids occurring in food 
oils and fats, these salts being obtained either from edible fats and 
oils or from distilled food fatty acids.  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content on the anhydrous basis not less than 95 % (105 °C till a 
constant weight)  
Description  White or creamy white light powders, flakes or semi-solids  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 176
 
Identification  
Solubility  Sodium and potassium salts: soluble in water and ethanol. Calcium 
salts: insoluble in water, ethanol and ether  
Test for cations  Passes test  
Test for fatty acids  Passes test  
Purity  
Sodium  Not less than 9 % and not more than 14 % expressed as Na  2 O 
Potassium  Not less than 13 % and not more than 21,5 % expressed as K  2 O 
Calcium  Not less than 8,5 % and not more than 13 % expressed as CaO  
Unsaponifiable matter  Not more than 2 %  
Free fatty acids  Not more than 3 % estimated as oleic acid  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Free alkali  Not more than 0,1 % expressed as NaOH  
Matter insoluble in alcohol  Not more than 0,2 % (sodium and potassium salts only)  
E 470b MAGNESIUM SALTS OF FATTY ACIDS 
Synonyms  
Definition  Magnesium salts of fatty acids occurring in foods oils and fats, these 
salts being obtained either from edible fats and oils or from distilled food fatty acids
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content on the anhydrous basis not less than 95 % (105 °C till a 
constant weight)  
Description  White or creamy-white light powders, flakes or semi-solids  
Identification  
Solubility  Insoluble in water, partially soluble in ethanol and ether  
Test for magnesium  Passes test  
Test for fatty acids  Passes test  
Purity  
Magnesium  Not less than 6,5 % and not more than 11 % expressed as MgO  
Free alkali  Not more than 0,1 % expressed as MgO  
Unsaponifiable matter  Not more than 2 %  
Free fatty acids  Not more than 3 % estimated as oleic acid  
Arsenic  Not more than 3 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 177
 
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS 
Synonyms  Glyceryl monostearate; Glyceryl monopalmitate; Glyceryl mono ­
oleate, etc.; Monostearin; Monopalmitin; Monoolein, etc.; GMS (for glyceryl monostearate)
 
Definition  Mono- and diglycerides of fatty acids consist of mixtures of glycerol 
mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content of mono- and diesters: not less than 70 %  
Description  The product varies from a pale yellow to pale brown oily liquid to a 
white or slightly off-white hard waxy solid. The solids may be in the 
form of flakes, powders or small beads  
Identification  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a polyol  
Test for glycerol  Passes test  
Test for fatty acids  Passes test  
Solubility  Insoluble in water, soluble in ethanol and toluene at 50 °C  
Purity  
Water content  Not more than 2 % (Karl Fischer method)  
Acid value  Not more than 6  
Free glycerol  Not more than 7 %  
Polyglycerols  Not more than 4 % diglycerol and not more than 1 % higher poly ­
glycerols both based on total glycerol content  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Total glycerol  Not less than 16 % and not more than 33 %  
Sulphated ash  Not more than 0,5 % determined at 800 ± 25 °C  
Purity criteria apply to the additive free of sodium, potassium and calcium salts 
of fatty acids, however these substances may be present up to a maximum level 
of 6 % (expressed as sodium oleate)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 178
 
E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF 
FATTY ACIDS 
Synonyms  Acetic acid esters of mono- and diglycerides; Acetoglycerides; 
Acetylated mono- and diglycerides; Acetic and fatty acid esters of glycerol
 
Definition  Esters of glycerol with acetic and fatty acids occurring in food fats 
and oils. They may contain small amounts of free glycerol, free fatty 
acids, free acetic acid and free glycerides  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Clear, mobile liquids to solids, from white to pale yellow in colour  
Identification  
Test for glycerol  Passes test  
Test for fatty acids  Passes test  
Test for acetic acid  Passes test  
Solubility  Insoluble in water. Soluble in ethanol  
Purity  
Acids other than acetic and fatty acids  Less than 1 %  
Free glycerol  Not more than 2 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Total acetic acid  Not less than 9 % and not more than 32 %  
Free fatty acids (and acetic acid)  Not more than 3 % estimated as oleic acid  
Total glycerol  Not less than 14 % and not more than 31 %  
Sulphated ash  Not more than 0,5 % determined at 800 ± 25 °C  
Purity criteria apply to the additive free of sodium, potassium and calcium salts 
of fatty acids, however these substances may be present up to a maximum level 
of 6 % (expressed as sodium oleate)  
E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF 
FATTY ACIDS 
Synonyms  Lactic acid esters of mono- and diglycerides; Lactoglycerides; 
Mono- and diglycerides of fatty acids esterified with lactic acid  
Definition  Esters of glycerol with lactic acid and fatty acids occurring in food 
fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 179
 
Description  Clear, mobile liquids to waxy solids of variable consistency, from 
white to pale yellow in colour  
Identification  
Test for glycerol,  Passes test  
Test for fatty acids  Passes test  
Test for lactic acid  Passes test  
Solubility  Insoluble in cold water but dispersible in hot water  
Purity  
Acids other than lactic and fatty acids  Less than 1 %  
Free glycerol  Not more than 2 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Total lactic acid  Not less than 13 % and not more than 45 %  
Free fatty acids (and lactic acid)  Not more than 3 % estimated as oleic acid  
Total glycerol  Not less than 13 % and not more than 30 %  
Sulphated ash  Not more than 0,5 % (800 ± 25 °C)  
Purity criteria apply to the additive free of sodium, potassium and calcium salts 
of fatty acids, however these substances may be present up to a maximum level 
of 6 % (expressed as sodium oleate)  
E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF 
FATTY ACIDS 
Synonyms  Citrem; Citric acid esters of mono- and diglycerides; Citroglycerides; 
Mono- and diglycerides of fatty acids esterified with citric acid  
Definition  Esters of glycerol with citric acid and fatty acids occurring in food 
oils and fats. They may contain small amounts of free glycerol, free 
fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium, potassium or calcium salts suitable for the purpose and authorised as food additives according 
to this Regulation.
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Yellowish or light brown liquids to waxy solids or semi-solids  
Identification  
Test for glycerol  Passes test  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 180
 
Test for fatty acids  Passes test  
Test for citric acid  Passes test  
Solubility  Insoluble in cold water, dispersible in hot water, soluble in oils and 
fats, insoluble in cold ethanol  
Purity  
Acids other than citric and fatty acids  Less than 1 %  
Free glycerol  Not more than 2 %  
Total glycerol  Not less than 8 % and not more than 33 %  
Total citric acid  Not less than 13 % and not more than 50 %  
Sulphated ash  Non-neutralised products: not more than 0,5 % (800 ± 25 °C) 
Partially or wholly neutralised products: not more than 10 % (800 ± 
25 °C)  
Lead  Not more than 2 mg/kg  
Acid value  Not more than 130  
Purity criteria apply to the additive free of sodium, potassium and calcium salts 
of fatty acids, however, these substances may be present up to a maximum level 
of 6 % (expressed as sodium oleate)  
E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES 
OF FATTY ACIDS 
Synonyms  Tartaric acid esters of mono- and diglycerides; Mono- and 
diglycerides of fatty acids esterified with tartaric acid  
Definition  Esters of glycerol with tartaric acid and fatty acids occurring in food 
fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Sticky viscous yellowish liquids to hard yellow waxes  
Identification  
Test for glycerol  Passes test  
Test for fatty acids  Passes test  
Test for tartaric acid  Passes test  
Purity  
Acids other than tartaric and fatty acids  Less than 1,0 %  
Free glycerol  Not more than 2 %  
Total glycerol  Not less than 12 % and not more than 29 %  
Arsenic  Not more than 3 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 181
 
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Total tartaric acid  Not less than 15 % and not more than 50 %  
Free fatty acids  Not more than 3 % estimated as oleic acid  
Sulphated ash  Not more than 0,5 % (800 ± 25 °C)  
Purity criteria apply to the additive free of sodium, potassium and calcium salts 
of fatty acids, however these substances may be present up to a maximum level 
of 6 % (expressed as sodium oleate)  
E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- 
AND DIGLYCERIDES OF FATTY ACIDS 
Synonyms  Diacetyltartaric acid esters of mono- and diglycerides; Mono-and 
diglycerides of fatty acids esterified with mono- and diacetyltartaric 
acid; Diacetyltartaric and fatty acid esters of glycerol  
Definition  Mixed esters of glycerol with mono- and diacetyltartaric acids 
(obtained from tartaric acid) and fatty acids occurring in food fats 
and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Sticky viscous liquids through a fat-like consistency to yellow waxes 
which hydrolyse in moist air to liberate acetic acid  
Identification  
Test for glycerol  Passes test  
Test for fatty acids  Passes test  
Test for tartaric acid  Passes test  
Test for acetic acid  Passes test  
Purity  
Acids other than acetic, tartaric and fatty 
acids  Less than 1 %  
Free glycerol  Not more than 2 %  
Total glycerol  Not less than 11 % and not more than 28 %  
Sulphated ash  Not more than 0,5 % determined at 800 ± 25 °C  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 182
 
Total tartaric acid  Not less than 10 % and not more than 40 %  
Total acetic acid  Not less than 8 % and not more than 32 %  
Acid value  Not less than 40 and not more than 130  
Purity criteria apply to the additive free of sodium, potassium and calcium salts 
of fatty acids, however these substances may be present up to a maximum level 
of 6 % (expressed as sodium oleate)  
E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- 
AND DIGLYCERIDES OF FATTY ACIDS 
Synonyms  Mono- and diglycerides of fatty acids esterified with acetic acid and 
tartaric acid  
Definition  Esters of glycerol with acetic and tartaric acids and fatty acids 
occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids, and 
free glycerides. May contain mono- and diacetyltartaric esters of 
mono- and diglycerides of fatty acids
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Sticky liquids to solids, from white to pale-yellow in colour  
Identification  
Test for glycerol  Passes test  
Test for fatty acids  Passes test  
Test for tartaric acid  Passes test  
Test for acetic acid  Passes test  
Purity  
Acids other than acetic, tartaric and fatty 
acids  Less than 1,0 %  
Free glycerol  Not more than 2 %  
Total glycerol  Not less than 12 % and not more than 27 %  
Sulphated ash  Not more than 0,5 % (800 ± 25 °C)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Total acetic acid  Not less than 10 % and not more than 20 %  
Total tartaric acid  Not less than 20 % and not more than 40 %  
Free fatty acids  Not more than 3 % estimated as oleic acid  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 183
 
Purity criteria apply to the additive free of sodium, potassium and calcium salts 
of fatty acids, however these substances may be present up to a maximum level 
of 6 % (expressed as sodium oleate)  
E 473 SUCROSE ESTERS OF FATTY ACIDS 
Synonyms  Sucroesters; Sugar esters  
Definition  Essentially the mono-, di- and triesters of sucrose with fatty acids 
occurring in food fats and oils. They may be prepared from sucrose 
and the methyl, ethyl and vinyl esters of food fatty acids (including 
lauric acid) or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propan-2-ol, 2-methyl-1-propanol, propylene glycol, methyl 
ethyl ketone and supercritical carbondioxide may be used for their 
preparation.  p-methoxy phenol can be used as a stabiliser during the 
manufacturing procedure.
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 80 %  
Description  Stiff gels, soft solids or white to slightly greyish-white powders  
Identification  
Test for sugar  Passes test  
Test for fatty acids  Passes test  
Solubility  Sparingly soluble in water, soluble in ethanol  
Purity  
Sulphated ash  Not more than 2 % (800 ± 25 °C)  
Free sugar  Not more than 5 %  
Free fatty acids  Not more than 3 % estimated as oleic acid  
p-methoxy-phenol  Not more than 100 μg/kg 
Acetaldehyde  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Methanol  Not more than 10 mg/kg  
Dimethylsulphoxide  Not more than 2 mg/kg  
Dimethylformamide  Not more than 1 mg/kg  
2-methyl-1-propanol  Not more than 10 mg/kg  
Ethyl acetate  
Not more than 350 mg/kg, singly or in combination Propan-2-ol  
Propylene glycol  9 
> > > > = 
> > > > ; 
Methyl ethyl ketone Not more than 10 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 184
 
Purity criteria apply to the additive free of sodium, potassium and calcium salts 
of fatty acids, however these substances may be present up to a maximum level 
of 6 % (expressed as sodium oleate)  
E 474 SUCROGLYCERIDES 
Synonyms  Sugar glycerides  
Definition  Sucroglycerides are produced by reacting sucrose with an edible fat 
or oil to produce a mixture of essentially mono-, di- and triesters of 
sucrose and fatty acids (including lauric acid) together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethyl ­
formamide, ethyl acetate, 2-methyl-1-propanol and propan-2-ol
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 40 % and not more than 60 % of sucrose fatty 
acid esters  
Description  Soft solid masses, stiff gels or white to off-white powders  
Identification  
Test for sugar  Passes test  
Test for fatty acids  Passes test  
Solubility  Insoluble in cold water, soluble in ethanol  
Purity  
Sulphated ash  Not more than 2 % (800 ± 25 °C)  
Free sugar  Not more than 5 %  
Free fatty acids  Not more than 3 % (estimated as oleic acid)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Methanol  Not more than 10 mg/kg  
Dimethylformamide  Not more than 1 mg/kg  
2-Methyl-1-propanol  
Not more than 10 mg/kg, single or in combination  
Cyclohexane 9 
> = 
> ; 
Ethyl acetate  
Not more than 350 mg/kg, single or in combination  
Propan-2-ol 9 
> = 
> ; 
Purity criteria apply to the additive free of sodium, potassium and calcium salts 
of fatty acids, however these substances may be present up to a maximum level 
of 6 % (expressed as sodium oleate)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 185
 
E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS 
Synonyms  Polyglycerol fatty acid esters; Polyglycerin esters of fatty acid esters  
Definition  Polyglycerol esters of fatty acids are produced by the esterification 
of polyglycerol with food fats and oils or with fatty acids occurring 
in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of poly ­
glycerols equal to or higher than heptaglycerol
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content of total fatty acid ester not less than 90 %  
Description  Light yellow to amber, oily to very viscous liquids; light tan to 
medium brown, plastic or soft solids; and light tan to brown, hard, 
waxy solids  
Identification  
Test for glycerol,  Passes test  
Test for polyglycerols  Passes test  
Test for fatty acids  Passes test  
Solubility  The esters range from very hydrophilic to very lipophilic, but as a 
class tend to be dispersible in water and soluble in organic solvents 
and oils  
Purity  
Sulphated ash  Not more than 0,5 % (800 ± 25 °C)  
Acids other than fatty acids  Less than 1 %  
Free fatty acids  Not more than 6 % estimated as oleic acid  
Total glycerol and polyglycerol  Not less than 18 % and not more than 60 %  
Free glycerol and polyglycerol  Not more than 7 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Purity criteria apply to the additive free of sodium, potassium and calcium salts 
of fatty acids, however these substances may be present up to a maximum level 
of 6 % (expressed as sodium oleate)  
E 476 POLYGLYCEROL POLYRICINOLEATE 
Synonyms  Glycerol esters of condensed castor oil fatty acids; Polyglycerol 
esters of polycondensed fatty acids from castor oil; Polyglycerol esters of interesterified ricinoleic acid; PGPR
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 186
 
Definition  Polyglycerol polyricinoleate is prepared by the esterification of poly ­
glycerol with condensed castor oil fatty acids  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Clear, highly viscous liquid  
Identification  
Solubility  Insoluble in water and in ethanol; soluble in ether, hydrocarbons and 
halogenated hydrocarbons  
Test for glycerol  Passes test  
Test for polyglycerol  Passes test  
Test for ricinoleic acid  Passes test  
Refractive index  [n]  D 65 between 1,4630 and 1,4665  
Purity  
Polyglycerols  The polyglycerol moiety shall be composed of not less than 75 % of 
di-, tri- and tetraglycerols and shall contain not more than 10 % of 
polyglycerols equal to or higher than heptaglycerol  
Hydroxyl value  Not less than 80 and not more than 100  
Acid value  Not more than 6  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDS 
Synonyms  Propylene glycol esters of fatty acids  
Definition  Consists of mixtures of propane-1,2-diol mono- and diesters of fatty 
acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of 
trimer. Organic acids other than food fatty acids are absent
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content of total fatty acid ester not less than 85 %  
Description  Clear liquids or waxy white flakes, beads or solids having a bland 
odour  
Identification  
Test for propylene glycol  Passes test  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 187
 
Test for fatty acids  Passes test  
Purity  
Sulphated ash  Not more than 0,5 % (800 ± 25 °C)  
Acids other than fatty acids  Less than 1 %  
Free fatty acids  Not more than 6 % estimated as oleic acid  
Total propane-1,2-diol  Not less than 11 % and not more than 31 %  
Free propane-1,2-diol  Not more than 5 %  
Dimer and trimer of propylene glycol  Not more than 0,5 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Purity criteria apply to the additive free of sodium, potassium and calcium salts 
of fatty acids, however these substances may be present up to a maximum level 
of 6 % (expressed as sodium oleate)  
E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED 
WITH MONO- AND DIGLYCERIDES OF FATTY ACIDS 
Synonyms  TOSOM  
Definition  Thermally oxidised soya bean oil interacted with mono- and 
diglycerides of fatty acids is a complex mixture of esters of 
glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and deodorisation under vacuum at 130 °C of 10 % of thermally 
oxidised soya bean oil and 90 % mono- and diglycerides of food 
fatty acids. Soya bean oil is exclusively made from strains of soya beans
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Pale yellow to light brown a waxy or solid consistency  
Identification  
Solubility  Insoluble in water. Soluble in hot oil or fat  
Purity  
Melting range  55-65 °C  
Free fatty acids  Not more than 1,5 % estimated as oleic acid  
Free glycerol  Not more than 2 %  
Total fatty acids  83-90 %  
Total glycerol  16-22 %  
Fatty acid methyl esters, not forming 
adduct with urea  Not more than 9 % of total fatty acid methyl esters  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 188
 
Fatty acids, insoluble in petroleum ether  Not more than 2 % of total fatty acids  
Peroxide value  Not more than 3  
Epoxides  Not more than 0,03 % oxirane oxygen  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 481 SODIUM STEAROYL-2-LACTYLATE 
Synonyms  Sodium stearoyl lactylate; Sodium stearoyl lactate  
Definition  A mixture of the sodium salts of stearoyl lactylic acids and its 
polymers and minor amounts of sodium salts of other related 
acids, manufactured by the reaction of stearic acid and lactic acid. 
Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
 
Einecs  246-929-7  
Chemical name  Sodium di-2-stearoyl lactate 
Sodium di(2-stearoyloxy)propionate  
Chemical formula  C  21 H 39 O 4 Na; C  19 H 35 O 4 Na (major components)  
Molecular weight  
Assay  
Description  White or slightly yellowish powder or brittle solid with a char ­
acteristic odour  
Identification  
Test for sodium  Passes test  
Test for fatty acids  Passes test  
Test for lactic acid  Passes test  
Solubility  Insoluble in water. Soluble in ethanol  
Purity  
Sodium  Not less than 2,5 % and not more than 5 %  
Ester value  Not less than 90 and not more than 190  
Acid value  Not less than 60 and not more than 130  
Total lactic acid  Not less than 15 % and not more than 40 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 482 CALCIUM STEAROYL-2-LACTYLATE 
Synonyms  Calcium stearoyl lactate  
Definition  A mixture of the calcium salts of stearoyl lactylic acids and its 
polymers and minor amounts of calcium salts of other related 
acids, manufactured by the reaction of stearic acid and lactic acid. 
Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 189
 
Einecs  227-335-7  
Chemical name  Calcium di-2-stearoyl lactate 
Calcium di(2-stearoyloxy)propionate  
Chemical formula  C  42 H 78 O 8 Ca; C  38 H 70 O 8 Ca, C  40 H 74 O 8 Ca (major components)  
Molecular weight  
Assay  
Description  White or slightly yellowish powder or brittle solid with a char ­
acteristic odour  
Identification  
Test for calcium  Passes test  
Test for fatty acids  Passes test  
Test for lactid acid  Passes test  
Solubility  Slightly soluble in hot water  
Purity  
Calcium  Not less than 1 % and not more than 5,2 %  
Ester value  Not less than 125 and not more than 190  
Total lactic acid  Not less than 15 % and not more than 40 %  
Acid value  Not less than 50 and not more than 130  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 483 STEARYL TARTRATE 
Synonyms  Stearyl palmityl tartrate  
Definition  Product of the esterification of tartaric acid with commercial stearyl 
alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materials
 
Einecs  
Chemical name  Distearyl tartrate 
Dipalmityl tartrate 
Stearylpalmityl tartrate  
Chemical formula  C  40 H 78 O 6 (Distearyl tartrate) 
C 36 H 70 O 6 (Dipalmityl tartrate) 
C 38 H 74 O 6 (Stearylpalmityl tartrate)  
Molecular weight  655 (Distearyl tartrate) 
599 (Dipalmityl tartrate) 
627 (Stearylpalmityl tartrate)  
Assay  Content of total ester not less than 90 % corresponding to an ester 
value of not less than 163 and not more than 180  
Description  Cream-coloured unctuous solid (at 25 °C)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 190
 
Identification  
Test for tartrate  Passes test  
Melting range  Between 67 °C and 77 °C. After saponification the saturated long 
chain fatty alcohols have a melting range of 49 °C to 55 °C  
Purity  
Hydroxyl value  Not less than 200 and not more than 220  
Acid value  Not more than 5,6  
Total tartaric acid  Not less than 18 % and not more than 35 %  
Sulphated ash  Not more than 0,5 % (800 ± 25 °C)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Unsaponifiable matter  Not less than 77 % and not more than 83 %  
Iodine value  Not more than 4 (Wijs method)  
E 491 SORBITAN MONOSTEARATE 
Synonyms  
Definition  A mixture of the partial esters of sorbitol and its anhydrides with 
edible, commercial stearic acid  
Einecs  215-664-9  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 95 % of a mixture of sorbitol, sorbitan, and 
isosorbide esters  
Description  Light, cream- to tan-coloured beads or flakes or a hard, waxy solid 
with a slight characteristic odour  
Identification  
Solubility  Soluble at temperatures above its melting point in toluene, dioxane, 
carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble 
in petroleum ether and acetone; insoluble in cold water but 
dispersible in warm water; soluble with haze at temperatures above 50 °C in mineral oil and ethyl acetate
 
Congealing range  50-52 °C  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a polyol  
Purity  
Water content  Not more than 2 % (Karl Fischer method)  
Sulphated ash  Not more than 0,5 %  
Acid value  Not more than 10  
Saponification value  Not less than 147 and not more than 157  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 191
 
Hydroxyl value  Not less than 235 and not more than 260  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 492 SORBITAN TRISTEARATE 
Synonyms  
Definition  A mixture of the partial esters of sorbitol and its anhydrides with 
edible, commercial stearic acid  
Einecs  247-891-4  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 95 % of a mixture of sorbitol, sorbitan, and 
isosorbide esters  
Description  Light, cream- to tan-coloured beads or flakes or hard, waxy solid 
with a slight odour  
Identification  
Solubility  Slightly soluble in toluene, ether, carbon tetrachloride and ethyl 
acetate; dispersible in petroleum ether, mineral oil, vegetable oils, 
acetone and dioxane; insoluble in water, methanol and ethanol  
Congealing range  47-50 °C  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a polyol  
Purity  
Water content  Not more than 2 % (Karl Fischer method)  
Sulphated ash  Not more than 0,5 %  
Acid value  Not more than 15  
Saponification value  Not less than 176 and not more than 188  
Hydroxyl value  Not less than 66 and not more than 80  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 493 SORBITAN MONOLAURATE 
Synonyms  
Definition  A mixture of the partial esters of sorbitol and its anhydrides with 
edible, commercial lauric acid  
Einecs  215-663-3  
Chemical name  
Chemical formula  
Molecular weight  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 192
 
Assay  Content not less than 95 % of a mixture of sorbitol, sorbitan, and 
isosorbide esters  
Description  Amber-coloured oily viscous liquid, light cream to tan-coloured 
beads or flakes or a hard, waxy solid with a slight odour  
Identification  
Solubility  Dispersible in hot and cold water  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a polyol  
Purity  
Water content  Not more than 2 % (Karl Fischer method)  
Sulphated ash  Not more than 0,5 %  
Acid value  Not more than 7  
Saponification value  Not less than 155 and not more than 170  
Hydroxyl value  Not less than 330 and not more than 358  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 494 SORBITAN MONOOLEATE 
Synonyms  
Definition  A mixture of the partial esters of sorbitol and its anhydrides with 
edible, commercial oleic acid. Major constituent is 1,4-sorbitan 
monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate
 
Einecs  215-665-4  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 95 % of a mixture of sorbitol, sorbitan and 
isosorbide esters  
Description  Amber-coloured viscous liquid, light cream to tan-coloured beads or 
flakes or a hard, waxy solid with a slight characteristic odour  
Identification  
Solubility  Soluble at temperatures above its melting point in ethanol, ether, 
ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetra-chloride. Insoluble in cold water, dispersible in warm water
 
Iodine value  The residue of oleic acid, obtained from the saponification of the 
sorbitan monooleate in assay, has a iodine value between 80 and 100  
Purity  
Water content  Not more than 2 % (Karl Fischer method)  
Sulphated ash  Not more than 0,5 %  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 193
 
Acid value  Not more than 8  
Saponification value  Not less than 145 and not more than 160  
Hydroxyl value  Not less than 193 and not more than 210  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 495 SORBITAN MONOPALMITATE 
Synonyms  Sorbitan palmitate  
Definition  A mixture of the partial esters of sorbitol and its anhydrides with 
edible, commercial palmitic acid  
Einecs  247-568-8  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 95 % of a mixture of sorbitol, sorbitan, and 
isosorbide esters  
Description  Light cream to tan-coloured beads or flakes or a hard, waxy solid 
with a slight characteristic odour  
Identification  
Solubility  Soluble at temperatures above its melting point in ethanol, methanol, 
ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and 
carbon tetrachloride. Insoluble in cold water but dispersible in warm water
 
Congealing range  45-47 °C  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of polyol  
Purity  
Water content  Not more than 2 % (Karl Fischer method)  
Sulphate ash  Not more than 0,5 %  
Acid value  Not more than 7,5  
Saponification value  Not less than 140 and not more than 150  
Hydroxyl value  Not less than 270 and not more than 305  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
▼M5 
E 499 STIGMASTEROL-RICH PLANT STEROLS 
Synonyms  
Definition  Stigmasterol-rich plant sterols are derived from soybeans and are a 
chemically defined simple mixture that comprises not less than 95 % 
of plant sterols (stigmasterol, β-sitosterol, campesterol and brassi ­
casterol), with stigmasterol representing not less than 85 % of the stigmasterol-rich plant sterols.
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 194
 
Einecs  
Chemical name  
Stigmasterol  (3S,8S,9S,10R,13R,14S,17R)-17-(5-ethyl-6-methyl-hept-3-en-2-yl)- 
10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17 -dodecahydro-1Hcyclo ­
penta[a]phenanthren-3-ol  
β-Sitosterol  (3S,8S,9S,10R,13R,14S,17R)-17-[(2S,5S)-5-ethyl-6-methylheptan-2- 
yl]-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,1 6,17-dodecahydro-1Hcy ­
clopenta[a]phenanthren-3-ol  
Campesterol  (3S,8S,9S,10R,13R,14S,17R)-17-(5,6-dimethylheptan-2-yl)-10,13- 
dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dode cahydro-1Hcyclo ­
penta[a]phenanthren-3-ol  
Brassicasterol  (3S,8S,9S,10R,13R,14S,17R)-17-[(E,2R,5R)-5,6- dimethylhept-3-en- 
2-yl]-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16 ,17-dodecahydro- 1Hcyclopenta[a]phenanthren-3-ol
 
Chemical formula  
Stigmasterol  C  29 H 48 O 
β-Sitosterol  C  29 H 50 O 
Campesterol  C  28 H 48 O 
Brassicasterol  C  28 H 46 O 
Molecular weight  
Stigmasterol  412,6 g/mol  
β-Sitosterol  414,7 g/mol  
Campesterol  400,6 g/mol  
Brassicasterol  398,6 g/mol  
Assay (products containing only free 
sterols and stanols)  Content not less than 95 % on a total free sterol/stanol basis on the 
anhydrous basis  
Description  Free-flowing, white to off-white powders, pills or pastilles; 
colourless to pale yellow liquids  
Identification  
Solubility  Practically insoluble in water. Phytosterols and phytostanols are 
soluble in acetone and ethyl acetate.  
Stigmasterol content  Not less than 85 % (w/w)  
Other plant sterols/stanols: either 
singularly or in combination including Brassicasterol, campestanol, campesterol, 
Δ-7-campesterol, cholesterol, chleros ­
terol, sitostanol and β-sitosterol.
 Not more than 15 % (w/w)  
Purity  
Total Ash  Not more than 0,1 %  
Residual Solvents  Ethanol: Not more than 5 000 mg/kg  
Methanol: Not more than 50 mg/kg  
Water content  Not more than 4 % (Karl Fischer method)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 1 mg/kg  
Microbiological criteria  
Total plate count  Not more than 1 000 CFU/g  
Yeasts  Not more than 100 CFU/g  
Moulds  Not more than 100 CFU/g  ▼M5 2012R0231 — EN — 11.07.2014 — 008.001 — 195
 
Escherichia coli  Not more than 10 CFU/g  
Salmonella  spp.  Absent in 25 g  
▼B 
E 500 (i) SODIUM CARBONATE 
Synonyms  Soda ash  
Definition  
Einecs  207-838-8  
Chemical name  Sodium carbonate  
Chemical formula  Na  2 CO 3 · nH  2 O (n = 0, 1 or 10)  
Molecular weight  106,00 (anhydrous)  
Assay  Content not less than 99 % of Na  2 CO 3 on the anhydrous basis  
Description  Colourless crystals or white, granular or crystalline powder 
The anhydrous form is hygroscopic, the decahydrate efflorescent  
Identification  
Test for sodium  Passes test  
Test for carbonate  Passes test  
Solubility  Freely soluble in water. Insoluble in ethanol  
Purity  
Loss on drying  Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % 
(decahydrate) (70 °C raising gradually to 300 °C, to constant weight)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 500 (ii) SODIUM HYDROGEN CARBONATE 
Synonyms  Sodium bicarbonate; sodium acid carbonate; Bicarbonate of soda; 
Baking soda  
Definition  
Einecs  205-633-8  
Chemical name  Sodium hydrogen carbonate  
Chemical formula  NaHCO  3 
Molecular weight  84,01  
Assay  Content not less than 99 % on the anhydrous basis  
Description  Colourless or white crystalline masses or crystalline powder  
Identification  
Test for sodium  Passes test  
Test for carbonate  Passes test  
pH Between 8,0 and 8,6 (1 % solution)  
Solubility  Soluble in water. Insoluble in ethanol  
Purity  
Loss on drying  Not more than 0,25 % (over silica gel, 4 hours)  
Ammonium salts  No odour of ammonia detectable after heating  ▼M5 2012R0231 — EN — 11.07.2014 — 008.001 — 196
 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 500 (iii) SODIUM SESQUICARBONATE 
Synonyms  
Definition  
Einecs  208-580-9  
Chemical name  Sodium monohydrogen dicarbonate  
Chemical formula  Na  2 CO 3 · NaHCO  3 · 2H  2 O 
Molecular weight  226,03  
Assay  Content between 35,0 % and 38,6 % of NaHCO  3 and between 
46,4 % and 50,0 % of Na  2 CO 3 
Description  White flakes, crystals or crystalline powder  
Identification  
Test for sodium  Passes test  
Test for carbonate  Passes test  
Solubility  Freely soluble in water  
Purity  
Sodium chloride  Not more than 0,5 %  
Iron Not more than 20 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 501 (i) POTASSIUM CARBONATE 
Synonyms  
Definition  
Einecs  209-529-3  
Chemical name  Potassium carbonate  
Chemical formula  K  2 CO 3 · nH  2 O (n = 0 or 1,5)  
Molecular weight  138,21 (anhydrous)  
Assay  Content not less than 99,0 % on the anhydrous basis  
Description  White, very deliquescent powder. 
The hydrate occurs as small, white, translucent crystals or granules  
Identification  
Test for potassium  Passes test  
Test for carbonate  Passes test  
Solubility  Very soluble in water. Insoluble in ethanol  
Purity  
Loss on drying  Not more than 5 % (anhydrous) or 18 % (hydrate) (180 °C, 4 hours)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 197
 
Mercury  Not more than 1 mg/kg  
E 501 (ii) POTASSIUM HYDROGEN CARBONATE 
Synonyms  Potassium bicarbonate; Acid potassium carbonate  
Definition  
Einecs  206-059-0  
Chemical name  Potassium hydrogen carbonate  
Chemical formula  KHCO  3 
Molecular weight  100,11  
Assay  Content not less than 99,0 % and not more than 101,0 % KHCO  3 on 
the anhydrous basis  
Description  Colourless crystals or white powder or granules  
Identification  
Test for potassium  Passes test  
Test for carbonate  Passes test  
Solubility  Freely soluble in water. Insoluble in ethanol  
Purity  
Loss on drying  Not more than 0,25 % (over silica gel, 4 hours)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 503 (i) AMMONIUM CARBONATE 
Synonyms  
Definition  Ammonium carbonate consists of ammonium carbamate, ammonium 
carbonate and ammonium hydrogen carbonate in varying proportions  
Einecs  233-786-0  
Chemical name  Ammonium carbonate  
Chemical formula  CH  6 N 2 O 2 , CH  8 N 2 O 3 and CH  5 NO  3 
Molecular weight  Ammonium carbamate 78,06; ammonium carbonate 98,73; 
ammonium hydrogen carbonate 79,06  
Assay  Content not less than 30,0 % and not more than 34,0 % of NH  3 
Description  White powder or hard, white or translucent masses or crystals. 
Becomes opaque on exposure to air and is finally converted into white porous lumps or powder (of ammonium bicarbonate) due to 
loss of ammonia and carbon dioxide
 
Identification  
Test for ammonium  Passes test  
Test for carbonate  Passes test  
pH About 8,6 (5 % solution)  
Solubility  Soluble in water  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 198
 
Purity  
Non-volatile matter  Not more than 500 mg/kg  
Chlorides  Not more than 30 mg/kg  
Sulphate  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 503 (ii) AMMONIUM HYDROGEN CARBONATE 
Synonyms  Ammonium bicarbonate  
Definition  
Einecs  213-911-5  
Chemical name  Ammonium hydrogen carbonate  
Chemical formula  CH  5 NO  3 
Molecular weight  79,06  
Assay  Content not less than 99,0 %  
Description  White crystals or crystalline powder  
Identification  
Test for ammonium  Passes test  
Test for carbonate  Passes test  
pH About 8,0 (5 % solution)  
Solubility  Freely soluble in water. Insoluble in ethanol  
Purity  
Non-volatile matter  Not more than 500 mg/kg  
Chlorides  Not more than 30 mg/kg  
Sulphate  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 504 (i) MAGNESIUM CARBONATE 
Synonyms  Hydromagnesite  
Definition  Magnesium carbonate is a basic hydrated or a monohydrated 
magnesium carbonate or a mixture of the two.  
Einecs  208-915-9  
Chemical name  Magnesium carbonate  
Chemical formula  MgCO  3 · nH  2 O 
Assay  Not less than 24 % and not more than 26,4 % of Mg  
Description  Odourless, light, white friable masses or as a bulky white powder  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 199
 
Identification  
Test for magnesium  Passes test  
Test for carbonate  Passes test  
Solubility  Practically insoluble both in water or ethanol  
Purity  
Acid insoluble matter  Not more than 0,05 %  
Water soluble matter  Not more than 1,0 %  
Calcium  Not more than 0,4 %  
Arsenic  Not more than 4 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 504 (ii) MAGNESIUM HYDROXIDE CARBONATE 
Synonyms  Magnesium hydrogen carbonate; Magnesium subcarbonate (light or 
heavy); Hydrated basic magnesium carbonate; Magnesium carbonate 
hydroxide  
Definition  
Einecs  235-192-7  
Chemical name  Magnesium carbonate hydroxide hydrated  
Chemical formula  4MgCO  3 Mg(OH)  2 · 5H  2 O 
Molecular weight  485  
Assay  Mg content not less than 40,0 % and not more than 45,0 % 
calculated as MgO  
Description  Light, white friable mass or bulky white powder  
Identification  
Test for magnesium  Passes test  
Test for carbonate  Passes test  
Solubility  Practically insoluble in water. Insoluble in ethanol  
Purity  
Acid insoluble matter  Not more than 0,05 %  
Water soluble matter  Not more than 1,0 %  
Calcium  Not more than 1,0 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 507 HYDROCHLORIC ACID 
Synonyms  Hydrogen chloride; Muriatic acid  
Definition  
Einecs  231-595-7  
Chemical name  Hydrochloric acid  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 200
 
Chemical formula  HCl  
Molecular weight  36,46  
Assay  Hydrochloric acid is commercially available in varying concen ­
trations. Concentrated hydrochloric acid contains not less than 
35,0 % HCl  
Description  Clear, colourless or slightly yellowish, corrosive liquid having a 
pungent odour  
Identification  
Test for acid  Passes test  
Test for chloride  Passes test  
Solubility  Soluble in water and in ethanol  
Purity  
Total organic compounds  Total organic compounds (non-fluorine containing): not more than 
5 mg/kg 
Benzene: not more than 0,05 mg/kg 
Fluorinated compounds (total): not more than 25 mg/kg  
Non-volatile matter  Not more than 0,5 %  
Reducing substances  Not more than 70 mg/kg (as SO  2 ) 
Oxidising substances  Not more than 30 mg/kg (as Cl  2 ) 
Sulphate  Not more than 0,5 %  
Iron Not more than 5 mg/kg  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 508 POTASSIUM CHLORIDE 
Synonyms  Sylvine; Sylvite  
Definition  
Einecs  231-211-8  
Chemical name  Potassium chloride  
Chemical formula  KCl  
Molecular weight  74,56  
Assay  Content not less than 99 % on the dried basis  
Description  Colourless, elongated, prismatic or cubital crystals or white granular 
powder. Odourless  
Identification  
Solubility  Freely soluble in water. Insoluble in ethanol  
Test for potassium  Passes test  
Test for chloride  Passes test  
Purity  
Loss on drying  Not more than 1 % (105 °C, 2 hours)  
Test for sodium  Negative  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 201
 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 509 CALCIUM CHLORIDE 
Synonyms  
Definition  
Einecs  233-140-8  
Chemical name  Calcium chloride  
Chemical formula  CaCl  2 · nH  2 O (n = 0,2 or 6)  
Molecular weight  110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate)  
Assay  Content not less than 93,0 % on the anhydrous basis  
Description  White, odourless, hygroscopic powder or deliquescent crystals  
Identification  
Test for calcium  Passes test  
Test for chloride  Passes test  
Solubility  Soluble in water and in ethanol  
Purity  
Magnesium and alkali salts  Not more than 5 % on the dried basis (calculated as sulphates)  
Fluoride  Not more than 40 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 511 MAGNESIUM CHLORIDE 
Synonyms  
Definition  
Einecs  232-094-6  
Chemical name  Magnesium chloride  
Chemical formula  MgCl  2 · 6H  2 O 
Molecular weight  203,30  
Assay  Content not less than 99,0 %  
Description  Colourless, odourless, very deliquescent flakes or crystals  
Identification  
Test for magnesium  Passes test  
Test for chloride  Passes test  
Solubility  Very soluble in water, freely soluble in ethanol  
Purity  
Ammonium  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 202
 
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 512 STANNOUS CHLORIDE 
Synonyms  Tin chloride; Tin dichloride  
Definition  
Einecs  231-868-0  
Chemical name  Stannous chloride dihydrate  
Chemical formula  SnCl  2 · 2H  2 O 
Molecular weight  225,63  
Assay  Content not less than 98,0 %  
Description  Colourless or white crystals 
May have a slight odour of hydrochloric acid  
Identification  
Test for tin (II)  Passes test  
Test for chloride  Passes test  
Solubility  Water: soluble in less than its own weight of water, but it forms an 
insoluble basic salt with excess water 
Ethanol: soluble  
Purity  
Sulphate  Not more than 30 mg/kg  
Arsenic  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg  
E 513 SULPHURIC ACID 
Synonyms  Oil of vitriol; Dihydrogen sulphate  
Definition  
Einecs  231-639-5  
Chemical name  Sulphuric acid  
Chemical formula  H  2 SO 4 
Molecular weight  98,07  
Assay  Sulphuric acid is commercially available in varying concentrations. 
The concentrated form contains not less than 96,0 %  
Description  Clear, colourless or slightly brown, very corrosive oily liquid  
Identification  
Test for acid  Passes test  
Test for sulphate  Passes test  
Solubility  Miscible with water, with generation of much heat, also with ethanol  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 203
 
Purity  
Ash Not more than 0,02 %  
Reducing matter  Not more than 40 mg/kg (as SO  2 ) 
Nitrate  Not more than 10 mg/kg (on H  2 SO 4 basis)  
Chloride  Not more than 50 mg/kg  
Iron Not more than 20 mg/kg  
Selenium  Not more than 20 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 514 (i) SODIUM SULPHATE 
Synonyms  
Definition  
Einecs  
Chemical name  Sodium sulphate  
Chemical formula  Na  2 SO 4 · nH  2 O (n = 0 or 10)  
Molecular weight  142,04 (anhydrous) 
322,04 (decahydrate)  
Assay  Content not less than 99,0 % on the anhydrous basis  
Description  Colourless crystals or a fine, white, crystalline powder 
The decahydrate is efflorescent  
Identification  
Test for sodium  Passes test  
Test for sulphate  Passes test  
pH Neutral or slightly alkaline to litmus paper (5 % solution)  
Purity  
Loss on drying  Not more than 1,0 % (anhydrous) or not more than 57 % (decahy ­
drate) at 130 °C  
Selenium  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 514 (ii) SODIUM HYDROGEN SULPHATE 
Synonyms  Acid sodium sulphate; Sodium bisulphate; Nitre cake  
Definition  
Chemical name  Sodium hydrogen sulphate  
Chemical formula  NaHSO  4 
Molecular weight  120,06  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 204
 
Assay  Content not less than 95,2 %  
Description  White, odourless crystals or granules  
Identification  
Test for sodium  Passes test  
Test for sulphate  Passes test  
pH Solutions are strongly acidic  
Purity  
Loss on drying  Not more than 0,8 %  
Water insoluble matter  Not more than 0,05 %  
Selenium  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 515 (i) POTASSIUM SULPHATE 
Synonyms  
Definition  
Einecs  
Chemical name  Potassium sulphate  
Chemical formula  K  2 SO 4 
Molecular weight  174,25  
Assay  Content not less than 99,0 %  
Description  Colourless or white crystals or crystalline powder  
Identification  
Test for potassium  Passes test  
Test for sulphate  Passes test  
pH Between 5,5 and 8,5 (5 % solution)  
Solubility  Freely soluble in water, insoluble in ethanol  
Purity  
Selenium  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 515 (ii) POTASSIUM HYDROGEN SULPHATE 
Synonyms  Potassium bisulphate; Potassium acid sulphate  
Definition  
Einecs  
Chemical name  Potassium hydrogen sulphate  
Chemical formula  KHSO  4 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 205
 
Molecular weight  136,17  
Assay  Content not less than 99 %  
Description  White deliquescent crystals, pieces or granules  
Identification  
Melting point  197 °C  
Test for potassium  Passes test  
Solubility  Freely soluble in water, insoluble in ethanol  
Purity  
Selenium  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 516 CALCIUM SULPHATE 
Synonyms  Gypsum; Selenite; Anhydrite  
Definition  
Einecs  231-900-3  
Chemical name  Calcium sulphate  
Chemical formula  CaSO  4 · nH  2 O (n = 0 or 2)  
Molecular weight  136,14 (anhydrous), 172,18 (dihydrate)  
Assay  Content not less than 99,0 % on the anhydrous basis  
Description  Fine, white to slightly yellowish-white odourless powder  
Identification  
Test for calcium  Passes test  
Test for sulphate  Passes test  
Solubility  Slightly soluble in water, insoluble in ethanol  
Purity  
Loss on drying  Anhydrous: not more than 1,5 % (250 °C, constant weight) 
Dihydrate: not more than 23 % (250 °C, constant weight)  
Fluoride  Not more than 30 mg/kg  
Selenium  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 517 AMMONIUM SULPHATE 
Synonyms  
Definition  
Einecs  231-984-1  
Chemical name  Ammonium sulphate  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 206
 
Chemical formula  (NH  4 ) 2 SO 4 
Molecular weight  132,14  
Assay  Content not less than 99,0 % and not more than 100,5 %  
Description  White powder, shining plates or crystalline fragments  
Identification  
Test for ammonium  Passes test  
Test for sulphate  Passes test  
Solubility  Freely soluble in water, insoluble in ethanol  
Purity  
Loss on ignition  Not more than 0,25 %  
Selenium  Not more than 30 mg/kg  
Lead  Not more than 3 mg/kg  
E 520 ALUMINIUM SULPHATE 
Synonyms  Alum  
Definition  
Einecs  
Chemical name  Aluminium sulphate  
Chemical formula  Al  2 (SO  4 ) 3 
Molecular weight  342,13  
Assay  Content not less than 99,5 % on the ignited basis  
Description  White powder, shining plates or crystalline fragments  
Identification  
Test for aluminium  Passes test  
Test for sulphate  Passes test  
pH 2,9 or above (5 % solution)  
Solubility  Freely soluble in water, insoluble in ethanol  
Purity  
Loss on ignition  Not more than 5 % (500 °C, 3 hours)  
Alkalies and alkaline earths  Not more than 0,4 %  
Selenium  Not more than 30 mg/kg  
Fluoride  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 521 ALUMINIUM SODIUM SULPHATE 
Synonyms  Soda alum; Sodium alum  
Definition  
Einecs  233-277-3  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 207
 
Chemical name  Aluminium sodium sulphate  
Chemical formula  AlNa(SO  4 ) 2 · nH  2 O (n = 0 or 12)  
Molecular weight  242,09 (anhydrous)  
Assay  Content on the anhydrous basis not less than 96,5 % (anhydrous) 
and 99,5 % (dodecahydrate)  
Description  Transparent crystals or white crystalline powder  
Identification  
Test for aluminium  Passes test  
Test for sodium  Passes test  
Test for sulphate  Passes test  
Solubility  Dodecahydrate is freely soluble in water. The anhydrous form is 
slowly soluble in water. Both forms are insoluble in ethanol  
Purity  
Loss on drying  Anhydrous form: not more than 10,0 % (220 °C, 16 hours) 
Dodecahydrate: not more than 47,2 % (50-55 °C, 1 hour then 
200 °C, 16 hours)  
Ammonium salts  No odour of ammonia detectable after heating  
Selenium  Not more than 30 mg/kg  
Fluoride  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 522 ALUMINIUM POTASSIUM SULPHATE 
Synonyms  Potassium alum; Potash alum  
Definition  
Einecs  233-141-3  
Chemical name  Aluminium potassium sulphate dodecahydrate  
Chemical formula  AlK(SO  4 ) 2 · 12 H  2 O 
Molecular weight  474,38  
Assay  Content not less than 99,5 %  
Description  Large, transparent crystals or white crystalline powder  
Identification  
Test for aluminium  Passes test  
Test for potassium  Passes test  
Test for sulphate  Passes test  
pH Between 3,0 and 4,0 (10 % solution)  
Solubility  Freely soluble in water, insoluble in ethanol  
Purity  
Ammonium salts  No odour of ammonia detectable after heating  
Selenium  Not more than 30 mg/kg  
Fluoride  Not more than 30 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 208
 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 523 ALUMINIUM AMMONIUM SULPHATE 
Synonyms  Ammonium alum  
Definition  
Einecs  232-055-3  
Chemical name  Aluminium ammonium sulphate  
Chemical formula  AlNH  4 (SO  4 ) 2 · 12 H  2 O 
Molecular weight  453,32  
Assay  Content not less than 99,5 %  
Description  Large, colourless crystals or white powder  
Identification  
Test for aluminium  Passes test  
Test for ammonium  Passes test  
Test for sulphate  Passes test  
Solubility  Freely soluble in water, soluble in ethanol  
Purity  
Alkali metals and alkaline earths  Not more than 0,5 %  
Selenium  Not more than 30 mg/kg  
Fluoride  Not more than 30 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 3 mg/kg  
Mercury  Not more than 1 mg/kg  
E 524 SODIUM HYDROXIDE 
Synonyms  Caustic soda; Lye  
Definition  
Einecs  215-185-5  
Chemical name  Sodium hydroxide  
Chemical formula  NaOH  
Molecular weight  40,0  
Assay  Content of solid forms not less than 98,0 % of total alkali (as 
NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH
 
Description  White or nearly white pellets, flakes, sticks, fused masses or other 
forms. Solutions are clear or slightly turbid, colourless or slightly 
coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 209
 
Identification  
Test for sodium  Passes test  
pH Strongly alkaline (1 % solution)  
Solubility  Very soluble in water. Freely soluble in ethanol  
Purity  
Water insoluble and organic matter  A 5 % solution is completely clear and colourless to slightly 
coloured  
Carbonate  Not more than 0,5 % (as Na  2 CO 3 ) 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 0,5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 525 POTASSIUM HYDROXIDE 
Synonyms  Caustic potash  
Definition  
Einecs  215-181-3  
Chemical name  Potassium hydroxide  
Chemical formula  KOH  
Molecular weight  56,11  
Assay  Content not less than 85,0 % of alkali calculated as KOH  
Description  White or nearly white pellets, flakes, sticks, fused masses or other 
forms  
Identification  
Test for potassium  Passes test  
pH Strongly alkaline (1 % solution)  
Solubility  Very soluble in water. Freely soluble in ethanol  
Purity  
Water insoluble matter  A 5 % solution is completely clear and colourless  
Carbonate  Not more than 3,5 % (as K  2 CO 3 ) 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 526 CALCIUM HYDROXIDE 
Synonyms  Slaked lime; Hydrated lime  
Definition  
Einecs  215-137-3  
Chemical name  Calcium hydroxide  
Chemical formula  Ca(OH)  2 
Molecular weight  74,09  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 210
 
Assay  Content not less than 92,0 %  
Description  White powder  
Identification  
Test for alkali  Passes test  
Test for calcium  Passes test  
Solubility  Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol  
Purity  
Acid insoluble ash  Not more than 1,0 %  
Magnesium and alkali salts  Not more than 2,7 %  
Barium  Not more than 300 mg/kg  
Fluoride  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
E 527 AMMONIUM HYDROXIDE 
Synonyms  Aqua ammonia; Strong ammonia solution  
Definition  
Einecs  
Chemical name  Ammonium hydroxide  
Chemical formula  NH  4 OH 
Molecular weight  35,05  
Assay  Content not less than 27 % of NH  3 
Description  Clear, colourless solution, having an exceedingly pungent, char ­
acteristic odour  
Identification  
Test for ammonia  Passes test  
Purity  
Non-volatile matter  Not more than 0,02 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
E 528 MAGNESIUM HYDROXIDE 
Synonyms  
Definition  
Einecs  
Chemical name  Magnesium hydroxide  
Chemical formula  Mg(OH)  2 
Molecular weight  58,32  
Assay  Content not less than 95,0 % on the anhydrous basis  
Description  Odourless, white bulky powder  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 211
 
Identification  
Test for magnesium  Passes test  
Test for alkali  Passes test  
Solubility  Practically insoluble in water and in ethanol  
Purity  
Loss on drying  Not more than 2,0 % (105 °C, 2 hours)  
Loss on ignition  Not more than 33 % (800 °C to constant weight)  
Calcium oxide  Not more than 1,5 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
E 529 CALCIUM OXIDE 
Synonyms  Burnt lime  
Definition  
Einecs  215-138-9  
Chemical name  Calcium oxide  
Chemical formula  CaO  
Molecular weight  56,08  
Assay  Content not less than 95,0 % on the ignited basis  
Description  Odourless, hard, white or greyish white masses of granules, or white 
to greyish powder  
Identification  
Test for alkali  Passes test  
Test for calcium  Passes test  
Reaction with water  Heat is generated on moistening the sample with water  
Solubility  Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol  
Purity  
Loss on ignition  Not more than 10,0 % (ca. 800 °C to constant weight)  
Acid insoluble matter  Not more than 1,0 %  
Barium  Not more than 300 mg/kg  
Magnesium and alkali salts  Not more than 3,6 %  
Fluoride  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
E 530 MAGNESIUM OXIDE 
Synonyms  
Definition  
Einecs  215-171-9  
Chemical name  Magnesium oxide  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 212
 
Chemical formula  MgO  
Molecular weight  40,31  
Assay  Content not less than 98,0 % on the ignited basis  
Description  A very bulky, white powder known as light magnesium oxide or a 
relative dense, white powder known as heavy magnesium oxide. 5 g 
of light magnesium oxide occupy a volume of at least 33 ml, while 5 g of heavy magnesium oxide occupy a volume of not more than 20 ml
 
Identification  
Test for alkali  Passes test  
Test for magnesium  Passes test  
Solubility  Practically insoluble in water. Insoluble in ethanol  
Purity  
Loss on ignition  Not more than 5,0 % (ca. 800 °C to constant weight)  
Calcium oxide  Not more than 1,5 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
E 535 SODIUM FERROCYANIDE 
Synonyms  Yellow prussiate of soda; Sodium hexacyanoferrate  
Definition  
Einecs  237-081-9  
Chemical name  Sodium ferrocyanide  
Chemical formula  Na  4 Fe(CN)  6 · 10 H  2 O 
Molecular weight  484,1  
Assay  Content not less than 99,0 %  
Description  Yellow crystals or crystalline powder  
Identification  
Test for sodium  Passes test  
Test for ferrocyanide  Passes test  
Purity  
Free moisture  Not more than 1,0 %  
Water insoluble matter  Not more than 0,03 %  
Chloride  Not more than 0,2 %  
Sulphate  Not more than 0,1 %  
Free cyanide  Not detectable  
Ferricyanide  Not detectable  
Lead  Not more than 5 mg/kg  
E 536 POTASSIUM FERROCYANIDE 
Synonyms  Yellow prussiate of potash; Potassium hexacyanoferrate  
Definition  
Einecs  237-722-2  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 213
 
Chemical name  Potassium ferrocyanide  
Chemical formula  K  4 Fe(CN)  6 · 3 H  2 O 
Molecular weight  422,4  
Assay  Content not less than 99,0 %  
Description  Lemon yellow crystals  
Identification  
Test for potassium  Passes test  
Test for ferrocyanide  Passes test  
Purity  
Free moisture  Not more than 1,0 %  
Water insoluble matter  Not more than 0,03 %  
Chloride  Not more than 0,2 %  
Sulphate  Not more than 0,1 %  
Free cyanide  Not detectable  
Ferricyanide  Not detectable  
Lead  Not more than 5 mg/kg  
E 538 CALCIUM FERROCYANIDE 
Synonyms  Yellow prussiate of lime; Calcium hexacyanoferrate  
Definition  
Einecs  215-476-7  
Chemical name  Calcium ferrocyanide  
Chemical formula  Ca  2 Fe(CN)  6 · 12H  2 O 
Molecular weight  508,3  
Assay  Content not less than 99,0 %  
Description  Yellow crystals or crystalline powder  
Identification  
Test for calcium  Passes test  
Test for ferrocyanide  Passes test  
Purity  
Free moisture  Not more than 1,0 %  
Water insoluble matter  Not more than 0,03 %  
Chloride  Not more than 0,2 %  
Sulphate  Not more than 0,1 %  
Free cyanide  Not detectable  
Ferricyanide  Not detectable  
Lead  Not more than 5 mg/kg  
E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC 
Synonyms  SALP  
Definition  
Einecs  232-090-4  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 214
 
Chemical name  Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate 
(A); Trisodium dialuminium pentadecahydrogen octaphosphate (B)  
Chemical formula  NaAl  3 H 14 (PO  4 ) 8 · 4H  2 O (A) 
Na 3 Al 2 H 15 (PO  4 ) 8 (B) 
Molecular weight  949,88 (A) 
897,82 (B)  
Assay  Content not less than 95,0 % (both forms)  
Description  White odourless powder  
Identification  
Test for sodium  Passes test  
Test for aluminium  Passes test  
Test for phosphate  Passes test  
pH Acid to litmus  
Solubility  Insoluble in water. Soluble in hydrochloric acid  
Purity  
Loss on ignition  19,5-21,0 % (A) (750-800 °C, 2 hours) 
15-16 % (B) (750-800 °C, 2 hours)  
Fluoride  Not more than 25 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 4 mg/kg  
Cadmium  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 551 SILICON DIOXIDE 
Synonyms  Silica; Silicium dioxide  
Definition  Silicon dioxide is an amorphous substance, which is produced 
synthetically by either a vapour-phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica 
gel, or hydrous silica. Fumed silica is produced in essentially an 
anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed water
 
Einecs  231-545-4  
Chemical name  Silicon dioxide  
Chemical formula  (SiO  2 ) n 
Molecular weight  60,08 (SiO  2 ) 
Assay  Content after ignition not less than 99,0 % (fumed silica) or 94,0 % 
(hydrated forms)  
Description  White, fluffy powder or granules. Hygroscopic  
Identification  
Test for silica  Positive  
Purity  
Loss on drying  Not more than 2,5 % (fumed silica, 105 °C, 2 hours) 
Not more than 8,0 % (precipitated silica and silica gel, 105 °C, 2 
hours)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 215
 
Not more than 70 % (hydrous silica, 105 °C, 2 hours)  
Loss on ignition  Not more than 2,5 % after drying (1 000 °C, fumed silica) 
Not more than 8,5 % after drying (1 000 °C, hydrated forms)  
Soluble ionisable salts  Not more than 5,0 % (as Na  2 SO 4 ) 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 552 CALCIUM SILICATE 
Synonyms  
Definition  Calcium silicate is a hydrous or anhydrous silicate with varying 
proportions of CaO and SiO  2 . The product should be free of 
asbestos.  
Einecs  215-710-8  
Chemical name  Calcium silicate  
Chemical formula  
Molecular weight  
Assay  Content on the anhydrous basis: 
— as SiO  2 not less than 50 % and not more than 95 % 
— as CaO not less than 3 % and not more than 35 %  
Description  White to off-white free-flowing powder that remains so after 
absorbing relatively large amounts of water or other liquids  
Identification  
Test for silicate  Passes test  
Test for calcium  Passes test  
Gel formation  Forms a gel with mineral acids  
Purity  
Loss on drying  Not more than 10 % (105 °C, 2 hours)  
Loss on ignition  Not less than 5 % and not more than 14 % (1 000 °C, constant 
weight)  
Sodium  Not more than 3 %  
Fluoride  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 553a (i) MAGNESIUM SILICATE 
Synonyms  
Definition  Magnesium silicate is a synthetic compound of which the molar ratio 
of magnesium oxide to silicon dioxide is approximately 2:5  
Einecs  
Chemical name  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 216
 
Chemical formula  
Molecular weight  
Assay  Content not less than 15 % of MgO and not less than 67 % of SiO  2 
on the ignited basis  
Description  Very fine, white, odourless powder, free from grittiness  
Identification  
Test for magnesium  Passes test  
Test for silicate  Passes test  
pH Between 7,0 and 10,8 (10 % slurry)  
Purity  
Loss on drying  Not more than 15 % (105 °C, 2 hours)  
Loss on ignition  Not more than 15 % after drying (1 000 °C, 20 min)  
Water soluble salts  Not more than 3 %  
Free alkali  Not more than 1 % (as NaOH)  
Fluoride  Not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 553a (ii) MAGNESIUM TRISILICATE 
Synonyms  
Definition  
Einecs  239-076-7  
Chemical name  Magnesium trisilicate  
Chemical formula  Mg  2 Si 3 O 8 · nH  2 O (approximate composition)  
Molecular weight  
Assay  Content not less than 29,0 % of MgO and not less than 65,0 % of 
SiO  2 both on the ignited basis  
Description  Fine, white powder, free from grittiness  
Identification  
Test for magnesium  Passes test  
Test for silicate  Passes test  
pH Between 6,3 and 9,5 (5 % slurry)  
Purity  
Loss on ignition  Not less than 17 % and not more than 34 % (1 000 °C)  
Water soluble salts  Not more than 2 %  
Free alkali  Not more than 1 % (as NaOH)  
Fluoride  Not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 217
 
E 553b TALC 
Synonyms  Talcum  
Definition  Naturally occurring form of hydrous magnesium silicate containing 
varying proportions of such associated minerals as alpha-quartz, 
calcite, chlorite, dolomite, magnesite, and phlogopite. The product should be free of asbestos.
 
Einecs  238-877-9  
Chemical name  Magnesium hydrogen metasilicate  
Chemical formula  Mg  3 (Si 4 O 10 )(OH)  2 
Molecular weight  379,22  
Assay  
Description  Light, homogeneous, white or almost white powder, greasy to the 
touch  
Identification  
Infrared absorption spectrum  Characteristic peaks at 3 677, 1 018 and 669 cm  -1 
X-ray diffraction  Peaks at 9,34/4,66/3,12 Å  
Solubility  Insoluble in water and ethanol  
Purity  
Loss on drying  Not more than 0,5 % (105 °C, 1 hour)  
Acid soluble matter  Not more than 6 %  
Water soluble matter  Not more than 0,2 %  
Acid-soluble iron  Not detectable  
Arsenic  Not more than 10 mg/kg  
Lead  Not more than 2 mg/kg  
E 554 SODIUM ALUMINIUM SILICATE 
Synonyms  Sodium silicoaluminate; Sodium aluminosilicate; Aluminium sodium 
silicate  
Definition  
Einecs  
Chemical name  Sodium aluminium silicate  
Chemical formula  
Molecular weight  
Assay  Content on the anhydrous basis: 
— as SiO  2 not less than 66,0 % and not more than 88,0 % 
— as Al  2 O 3 not less than 5,0 % and not more than 15,0 %  
Description  Fine white amorphous powder or beads  
Identification  
Test for sodium  Passes test  
Test for aluminium  Passes test  
Test for silicate  Passes test  
pH Between 6,5 and 11,5 (5 % slurry)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 218
 
Purity  
Loss on drying  Not more than 8,0 % (105 °C, 2 hours)  
Loss on ignition  Not less than 5,0 % and not more than 11,0 % on the anhydrous 
basis (1 000 °C to constant weight)  
Sodium  Not less than 5 % and not more than 8,5 % (as Na  2 O) on the 
anhydrous basis  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 555 POTASSIUM ALUMINIUM SILICATE 
Synonyms  Mica  
Definition  Natural mica consists of mainly potassium aluminium silicate (mus ­
covite)  
Einecs  310-127-6  
Chemical name  Potassium aluminium silicate  
Chemical formula  KAl  2 [AlSi  3 O 10 ](OH)  2 
Molecular weight  398  
Assay  Content not less than 98 %  
Description  Light grey to white crystalline platelets or powder  
Identification  
Solubility  Insoluble in water, diluted acids and alkali and organic solvents  
Purity  
Loss on drying  Not more than 0,5 % (105 °C, 2 hours)  
Antimony  Not more than 20 mg/kg  
Zinc Not more than 25 mg/kg  
Barium  Not more than 25 mg/kg  
Chromium  Not more than 100 mg/kg  
Copper  Not more than 25 mg/kg  
Nickel  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 2 mg/kg  
Lead  Not more than 5 mg/kg  
▼M3 
E 556 CALCIUM ALUMINIUM SILICATE  ( 1 ) 
▼B 
Synonyms  Calcium aluminosilicate; Calcium silicoaluminate; Aluminium 
calcium silicate  
Definition  
Einecs  
Chemical name  Calcium aluminium silicate  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 219  
( 1 ) Period of application: until 31 January 2014.
 Chemical formula  
Molecular weight  
Assay  Content on the anhydrous basis: 
— as SiO  2 not less than 44,0 % and not more than 50,0 % 
— as Al  2 O 3 not less than 3,0 % and not more than 5,0 % 
— as CaO not less than 32,0 % and not more than 38,0 %  
Description  Fine white, free-flowing powder  
Identification  
Test for calcium  Passes test  
Test for aluminium  Passes test  
Test for silicate  Passes test  
Purity  
Loss on drying  Not more than 10,0 % (105 °C, 2 hours)  
Loss on ignition  Not less than 14,0 % and not more than 18,0 on the anhydrous basis 
(1 000 °C, constant weight)  
Fluoride  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
▼M3 
E 559 ALUMINIUM SILICATE (KAOLIN)  ( 1 ) 
▼B 
Synonyms  Kaolin, light or heavy  
Definition  Aluminium silicate hydrous (kaolin) is a purified white plastic clay 
composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw 
kaolinitic clay used in the production of aluminium silicate shall 
have a level of dioxin which does not make it injurious to health or unfit for human consumption. The product should be free of asbestos
 
Einecs  215-286-4 (kaolinite)  
Chemical name  
Chemical formula  Al  2 Si 2 O 5 (OH)  4 (kaolinite)  
Molecular weight  264  
Assay  Content not less than 90 % (sum of silica and alumina, after igni ­
tion)  
Silica (SiO  2 ) Between 45 % and 55 %  
Alumina (Al  2 O 3 ) Between 30 % and 39 %  
Description  Fine, white or greyish white, unctuous powder. Kaolin is made up 
of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes
 
Identification  
Test for alumina  Passes test  
Test for silicate  Passes test  
X-ray diffraction  Characteristic peaks at 7,18/3,58/2,38/1,78 Å  
Infrared absorption spectrum  Peaks at 3 700 and 3 620 cm  -1 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 220  
( 1 ) Period of application: until 31 January 2014.
 Purity  
Loss on ignition  Between 10 and 14 % (1 000 °C, constant weight)  
Water soluble matter  Not more than 0,3 %  
Acid soluble matter  Not more than 2 %  
Iron Not more than 5 %  
Potassium oxide (K  2 O) Not more than 5 %  
Carbon  Not more than 0,5 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 570 FATTY ACIDS 
Synonyms  
Definition  Linear fatty acids, caprylic acid (C  8 ), capric acid (C  10 ), lauric acid 
(C 12 ), myristic acid (C  14 ), palmitic acid (C  16 ), stearic acid (C  18 ), 
oleic acid (C  18:1 ) 
Einecs  
Chemical name  Octanoic acid (C  8 ); decanoic acid (C  10 ); dodecanoic acid (C  12 ); 
tetradecanoic acid (C  14 ); hexadecanoic acid (C  16 ); octadecanoic 
acid (C  18 ); 9-octadecenoic acid (C  18:1 ) 
Chemical formula  
Molecular weight  
Assay  Not less than 98 % by chromatography  
Description  A colourless liquid or white solid obtained from oils and fats  
Identification  
Identification test  Individual fatty acids can be identified by acid value, iodine value, 
gas chromatography  
Purity  
Residue on ignition  Not more than 0,1 %  
Unsaponifiable matter  Not more than 1,5 %  
Water content  Not more than 0,2 % (Karl Fischer method)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 574 GLUCONIC ACID 
Synonyms  D-gluconic acid; Dextronic acid  
Definition  Gluconic acid is an aqueous solution of gluconic acid and glucono- 
delta-lactone  
Einecs  
Chemical name  Gluconic acid  
Chemical formula  C  6 H 12 O 7 (gluconic acid)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 221
 
Molecular weight  196,2  
Assay  Content not less than 49,0 % (as gluconic acid)  
Description  Colourless to light yellow, clear syrupy liquid  
Identification  
Formation of phenylhydrazine derivative  Positive. Compound formed melts between 196 °C and 202 °C with 
decomposition  
Purity  
Residue on ignition  Not more than 1,0 % 550 °C +/– 20 °C till disappearance of organic 
residues (black spots).  
Reducing matter  Not more than 2,0 % (as D-glucose)  
Chloride  Not more than 350 mg/kg  
Sulphate  Not more than 240 mg/kg  
Sulphite  Not more than 20 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 575 GLUCONO-DELTA-LACTONE 
Synonyms  Gluconolactone; GDL; D-Gluconic acid delta-lactone; Delta-gluco ­
nolactone  
Definition  Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D- 
gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 % - 66 %) and the delta- and gamma-lactones
 
Einecs  202-016-5  
Chemical name  D-Glucono-1,5-lactone  
Chemical formula  C  6 H 10 O 6 
Molecular weight  178,14  
Assay  Content not less than 99,0 % on the anhydrous basis  
Description  Fine, white, nearly odourless, crystalline powder  
Identification  
Formation of phenylhydrazine derivative 
of gluconic acid  Positive. Compound formed melts between 196 °C and 202 °C with 
decomposition  
Solubility  Freely soluble in water. Sparingly soluble in ethanol  
Purity  
Water content  Not more than 0,2 % (Karl Fischer method)  
Reducing substances  Not more than 0,5 % (as D-glucose)  
Lead  Not more than 1 mg/kg  
E 576 SODIUM GLUCONATE 
Synonyms  Sodium salt of D-gluconic acid  
Definition  Manufactured by fermentation or chemical catalytic oxidation  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 222
 
Einecs  208-407-7  
Chemical name  Sodium D-gluconate  
Chemical formula  C  6 H 11 NaO  7 (anhydrous)  
Molecular weight  218,14  
Assay  Content not less than 99,0 %  
Description  White to tan, granular to fine, crystalline powder  
Identification  
Test for sodium  Passes test  
Test for gluconate  Passes test  
Solubility  Very soluble in water. Sparingly soluble in ethanol  
pH Between 6,5 and 7,5 (10 % solution)  
Purity  
Reducing matter  Not more than 1,0 % (as D-glucose)  
Lead  Not more than 1 mg/kg  
E 577 POTASSIUM GLUCONATE 
Synonyms  Potassium salt of D-gluconic acid  
Definition  
Einecs  206-074-2  
Chemical name  Potassium D-gluconate  
Chemical formula  C  6 H 11 KO  7 (anhydrous) 
C 6 H 11 KO  7 · H 2 O (monohydrate)  
Molecular weight  234,25 (anhydrous) 
252,26 (monohydrate)  
Assay  Content not less than 97,0 % and not more than 103,0 % on dried 
basis  
Description  Odourless, free flowing white to yellowish white, crystalline powder 
or granules  
Identification  
Test for potassium  Passes test  
Test for gluconate  Passes test  
pH Between 7,0 and 8,3 (10 % solution)  
Purity  
Loss on drying  Anhydrous: not more than 3,0 % (105 °C, 4 hours, vacuum) 
Monohydrate: not less than 6 % and not more than 7,5 % (105 °C, 4 
hours, vacuum)  
Reducing substances  Not more than 1,0 % (as D-glucose)  
Lead  Not more than 2 mg/kg  
E 578 CALCIUM GLUCONATE 
Synonyms  Calcium salt of D-gluconic acid  
Definition  
Einecs  206-075-8  
Chemical name  Calcium di-D-gluconate  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 223
 
Chemical formula  C  12 H 22 CaO  14 (anhydrous) 
C 12 H 22 CaO  14 · H 2 O (monohydrate)  
Molecular weight  430,38 (anhydrous form) 
448,39 (monohydrate)  
Assay  anhydrous: Content not less than 98 % and not more than 102 % on 
the dried basis 
monohydrate: not less than 98 % and not more than 102 % on the 
‘as is’ basis.  
Description  Odourless, white crystalline granules or powder, stable in air  
Identification  
Test for calcium  Passes test  
Test for gluconate  Passes test  
Solubility  Soluble in water, insoluble in ethanol  
pH Between 6,0 and 8,0 (5 % solution)  
Purity  
Loss on drying  Not more than 3,0 % (105 °C, 16 hours) (anhydrous) 
Not more than 2,0 % (105 °C, 16 hours) (monohydrate)  
Reducing substances  Not more than 1,0 % (as D-glucose)  
Lead  Not more than 2 mg/kg  
E 579 FERROUS GLUCONATE 
Synonyms  
Definition  
Einecs  206-076-3  
Chemical name  Ferrous di-D-gluconate dihydrate; Iron(II) di-gluconate dihydrate  
Chemical formula  C  12 H 22 FeO  14 ·2H 2 O 
Molecular weight  482,17  
Assay  Content not less than 95 % on the dried basis  
Description  Pale greenish-yellow to yellowish-grey powder or granules, which 
may have a faint odour of burnt sugar  
Identification  
Solubility  Soluble with slight heating in water. Practically insoluble in ethanol  
Test for ferrous ion  Passes test  
Formation of phenylhy-drazine derivative 
of gluconic acid  Positive  
pH Between 4 and 5,5 (10 % solution)  
Purity  
Loss on drying  Not more than 10 % (105 °C, 16 hours)  
Oxalic acid  Not detectable  
Iron (Fe III)  Not more than 2 %  
Arsenic  Not more than 3 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 224
 
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
Reducing substances  Not more than 0,5 % expressed as glucose  
E 585 FERROUS LACTATE 
Synonyms  Iron(II) lactate; Iron(II) 2-hydroxy propanoate; 
Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1)  
Definition  
Einecs  227-608-0  
Chemical name  Ferrous 2-hydroxy propanoate  
Chemical formula  C  6 H 10 FeO  6 · nH  2 O (n = 2 or 3)  
Molecular weight  270,02 (dihydrate) 
288,03 (trihydrate)  
Assay  Content not less than 96 % on the dried basis  
Description  Greenish-white crystals or light green powder having a characteristic 
smell  
Identification  
Solubility  Soluble in water. Practically insoluble in ethanol  
Test for ferrous ion  Passes test  
Test for lactate  Passes test  
pH Between 4 and 6 (2 % solution)  
Purity  
Loss on drying  Not more than 18 % (100 °C, under vacuum, approximately 700 mm 
Hg) 
Iron (Fe III)  Not more than 0,6 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 586 4-HEXYLRESORCINOL 
Synonyms  4-Hexyl-1,3-benzenediol; Hexylresorcinol  
Definition  
Einecs  205-257-4  
Chemical name  4-Hexylresorcinol  
Chemical formula  C  12 H 18 O 2 
Molecular weight  197,24  
Assay  Not less than 98 % on the dried basis (4 hours at room temperature)  
Description  White powder  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 225
 
Identification  
Solubility  Freely soluble in ether and acetone; very slightly soluble in water  
Nitric acid test  To 1 ml of a saturated solution of the sample, add 1 ml of nitric 
acid. A light red colour appears  
Bromine test  To 1 ml of saturated solution of the sample, add 1 ml of bromine 
TS. A yellow, flocculent precipitate dissolves producing a yellow solution
 
Purity  
Melting range  62 to 67 °C  
Acidity  Not more than 0,05 %  
Sulphated ash  Not more than 0,1 %  
Resorcinol and other phenols  Shake about 1 g of the sample with 50 ml of water for a few 
minutes, filter, and to the filtrate add 3 drops of ferric chloride 
TS. No red or blue colour is produced  
Nickel  Not more than 2 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 3 mg/kg  
E 620 GLUTAMIC ACID 
Synonyms  L-Glutamic acid; L- α-Aminoglutaric acid  
Definition  
Einecs  200-293-7  
Chemical name  L-Glutamic acid; L-2-amino-pentanedioic acid  
Chemical formula  C  5 H 9 NO  4 
Molecular weight  147,13  
Assay  Content not less than 99,0 % and not more than 101,0 % on the 
anhydrous basis  
Solubility  Sparingly soluble in water; practically insoluble in ethanol or ether  
Description  White crystals or crystalline powder  
Identification  
Test for glutamic acid (by thin layer 
chromatography)  Passes test  
Specific rotation  [ α] D 20 between + 31,5° and + 32,2° 
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)  
pH Between 3,0 and 3,5 (saturated solution)  
Purity  
Loss on drying  Not more than 0,2 % (80 °C, 3 hours)  
Sulphated ash  Not more than 0,2 %  
Chloride  Not more than 0,2 %  
Pyrrolidone carboxylic acid  Not more than 0,2 %  
Arsenic  Not more than 2,5 mg/kg  
Lead  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 226
 
E 621 MONOSODIUM GLUTAMATE 
Synonyms  Sodium glutamate; MSG  
Definition  
Einecs  205-538-1  
Chemical name  Monosodium L-glutamate monohydrate  
Chemical formula  C  5 H 8 NaNO  4 · H 2 O 
Molecular weight  187,13  
Assay  Content not less than 99,0 % and not more than 101,0 % on the 
anhydrous basis  
Solubility  Freely soluble in water; practically insoluble in ethanol or ether  
Description  White, practically odourless crystals or crystalline powder  
Identification  
Test for sodium  Passes test  
Test for glutamic acid (by thin-layer 
chromatography)  Passes test  
Specific rotation  [ α] D 20 between + 24,8° and + 25,3° 
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)  
pH Between 6,7 and 7,2 (5 % solution)  
Purity  
Loss on drying  Not more than 0,5 % (98 °C, 5 hours)  
Chloride  Not more than 0,2 %  
Pyrrolidone carboxylic acid  Not more than 0,2 %  
Lead  Not more than 1 mg/kg  
E 622 MONOPOTASSIUM GLUTAMATE 
Synonyms  Potassium glutamate; MPG  
Definition  
Einecs  243-094-0  
Chemical name  Monopotassium L-glutamate monohydrate  
Chemical formula  C  5 H 8 KNO  4 · H 2 O 
Molecular weight  203,24  
Assay  Content not less than 99,0 % and not more than 101,0 % on the 
anhydrous basis  
Solubility  Freely soluble in water; practically insoluble in ethanol or ether  
Description  White, practically odourless crystals or crystalline powder  
Identification  
Test for potassium  Passes test  
Test for glutamic acid (by thin-layer 
chromatography)  Passes test  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 227
 
Specific rotation  [ α] D 20 between + 22,5° and + 24,0° 
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)  
pH Between 6,7 and 7,3 (2 % solution)  
Purity  
Loss on drying  Not more than 0,2 % (80 °C, 5 hours)  
Chloride  Not more than 0,2 %  
Pyrrolidone carboxylic acid  Not more than 0,2 %  
Lead  Not more than 1 mg/kg  
E 623 CALCIUM DIGLUTAMATE 
Synonyms  Calcium glutamate  
Definition  
Einecs  242-905-5  
Chemical name  Monocalcium di-L-glutamate  
Chemical formula  C  10 H 16 CaN  2 O 8 · nH  2 O (n = 0, 1, 2 or 4)  
Molecular weight  332,32 (anhydrous)  
Assay  Content not less than 98,0 % and not more than 102,0 % on the 
anhydrous basis  
Solubility  Freely soluble in water; practically insoluble in ethanol or ether  
Description  White, practically odourless crystals or crystalline powder  
Identification  
Test for calcium  Passes test  
Test for glutamic acid (by thin-layer 
chromatography)  Passes test  
Specific rotation  [ α] D 20 between + 27,4° and + 29,2° (for calcium diglutamate with n 
= 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)  
Purity  
Water content  Not more than 19,0 % (for calcium diglutamate with n = 4) (Karl 
Fischer)  
Chloride  Not more than 0,2 %  
Pyrrolidone carboxylic acid  Not more than 0,2 %  
Lead  Not more than 1 mg/kg  
E 624 MONOAMMONIUM GLUTAMATE 
Synonyms  Ammonium glutamate  
Definition  
Einecs  231-447-1  
Chemical name  Monoammonium L-glutamate monohydrate  
Chemical formula  C  5 H 12 N 2 O 4 · H 2 O 
Molecular weight  182,18  
Assay  Content not less than 99,0 % and not more 101,0 % on the 
anhydrous basis  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 228
 
Solubility  Freely soluble in water; practically insoluble in ethanol or ether  
Description  White, practically odourless crystals or crystalline powder  
Identification  
Test for ammonium  Passes test  
Test for glutamic acid (by thin-layer 
chromatography)  Passes test  
Specific rotation  [ α] D 20 between + 25,4° and + 26,4° 
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)  
pH Between 6,0 and 7,0 (5 % solution)  
Purity  
Loss on drying  Not more than 0,5 % (50 °C, 4 hours)  
Sulphated ash  Not more than 0,1 %  
Pyrrolidone carboxylic acid  Not more than 0,2 %  
Lead  Not more than 1 mg/kg  
E 625 MAGNESIUM DIGLUTAMATE 
Synonyms  Magnesium glutamate  
Definition  
Einecs  242-413-0  
Chemical name  Monomagnesium di-L-glutamate tetrahydrate  
Chemical formula  C  10 H 16 MgN  2 O 8 · 4H  2 O 
Molecular weight  388,62  
Assay  Content not less than 95,0 % and not more than 105,0 % on the 
anhydrous basis  
Solubility  Very soluble in water; practically insoluble in ethanol or ether  
Description  Odourless, white or off-white crystals or powder  
Identification  
Test for magnesium  Passes test  
Test for glutamic acid (by thin-layer 
chromatography)  Passes test  
Specific rotation  [ α] D 20 between + 23,8° and + 24,4° 
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)  
pH Between 6,4 and 7,5 (10 % solution)  
Purity  
Water content  Not more than 24 % (Karl Fischer)  
Chloride  Not more than 0,2 %  
Pyrrolidone carboxylic acid  Not more than 0,2 %  
Lead  Not more than 1 mg/kg  
E 626 GUANYLIC ACID 
Synonyms  5'-Guanylic acid  
Definition  
Einecs  201-598-8  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 229
 
Chemical name  Guanosine-5'-monophosphoric acid  
Chemical formula  C  10 H 14 N 5 O 8 P 
Molecular weight  363,22  
Assay  Content not less than 97,0 % on the anhydrous basis  
Solubility  Slightly soluble in water, practically insoluble in ethanol  
Description  Odourless, colourless or white crystals or white crystalline powder  
Identification  
Test for ribose  Passes test  
Test for organic phosphate  Passes test  
pH Between 1,5 and 2,5 (0,25 % solution)  
Spectrometry  Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm  
Purity  
Loss on drying  Not more than 1,5 % (120 °C, 4 hours)  
Other nucleotides  Not detectable by thin-layer chromatography  
Lead  Not more than 1 mg/kg  
E 627 DISODIUM GUANYLATE 
Synonyms  Sodium guanylate; Sodium 5'-guanylate  
Definition  
▼M3 
Einecs  226-914-1  
▼B 
Chemical name  Disodium guanosine-5'-monophosphate  
Chemical formula  C  10 H 12 N 5 Na 2 O 8 P · nH  2 O (n = ca. 7)  
Molecular weight  407,19 (anhydrous)  
Assay  Content not less than 97,0 % on the anhydrous basis  
Solubility  Soluble in water, sparingly soluble in ethanol, practically insoluble 
in ether  
Description  Odourless, colourless or white crystals or white crystalline powder  
Identification  
Test for ribose  Passes test  
Test for organic phosphate  Passes test  
Test for sodium  Passes test  
pH Between 7,0 and 8,5 (5 % solution)  
Spectrometry  maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm  
Purity  
Loss on drying  Not more than 25 % (120 °C, 4 hours)  
Other nucleotides  Not detectable by thin-layer chromatography  
Lead  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 230
 
E 628 DIPOTASSIUM GUANYLATE 
Synonyms  Potassium guanylate; Potassium 5'-guanylate  
Definition  
▼M3 
Einecs  221-849-5  
▼B 
Chemical name  Dipotassium guanosine-5'-monophosphate  
Chemical formula  C  10 H 12 K 2 N 5 O 8 P 
Molecular weight  439,40  
Assay  Content not less than 97,0 % on the anhydrous basis  
Solubility  Freely soluble in water, practically insoluble in ethanol  
Description  Odourless, colourless or white crystals or white crystalline powder  
Identification  
Test for ribose  Passes test  
Test for organic phosphate  Passes test  
Test for potassium  Passes test  
pH Between 7,0 and 8,5 (5 % solution)  
Spectrometry  Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm  
Purity  
Loss on drying  Not more than 5 % (120 °C, 4 hours)  
Other nucleotides  Not detectable by thin-layer chromatography  
Lead  Not more than 1 mg/kg  
E 629 CALCIUM GUANYLATE 
Synonyms  Calcium 5'-guanylate  
Definition  
Einecs  
Chemical name  Calcium guanosine-5'-monophosphate  
Chemical formula  C  10 H 12 CaN  5 O 8 P · nH  2 O 
Molecular weight  401,20 (anhydrous)  
Assay  Content not less than 97,0 % on the anhydrous basis  
Solubility  Sparingly soluble in water  
Description  Odourless, white or off-white crystals or powder  
Identification  
Test for ribose  Passes test  
Test for organic phosphate  Passes test  
Test for calcium  Passes test  
pH Between 7,0 and 8,0 (0,05 % solution)  
Spectrometry  Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 231
 
Purity  
Loss on drying  Not more than 23,0 % (120 °C, 4 hours)  
Other nucleotides  Not detectable by thin-layer chromatography  
Lead  Not more than 1 mg/kg  
E 630 INOSINIC ACID 
Synonyms  5'-Inosinic acid  
Definition  
Einecs  205-045-1  
Chemical name  Inosine-5'-monophosphoric acid  
Chemical formula  C  10 H 13 N 4 O 8 P 
Molecular weight  348,21  
Assay  Content not less than 97,0 % on the anhydrous basis  
Solubility  Freely soluble in water, slightly soluble in ethanol  
Description  Odourless, colourless or white crystals or powder  
Identification  
Test for ribose  Passes test  
Test for organic phosphate  Passes test  
pH Between 1,0 and 2,0 (5 % solution)  
Spectrometry  Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm  
Purity  
Loss on drying  Not more than 3,0 % (120 °C, 4 hours)  
Other nucleotides  Not detectable by thin-layer chromatography  
Lead  Not more than 1 mg/kg  
E 631 DISODIUM INOSINATE 
Synonyms  Sodium inosinate; Sodium 5'-inosinate  
Definition  
Einecs  225-146-4  
Chemical name  Disodium inosine-5'-monophosphate  
Chemical formula  C  10 H 11 N 4 Na 2 O 8 P · H 2 O 
Molecular weight  392,17 (anhydrous)  
Assay  Content not less than 97,0 % on the anhydrous basis  
Solubility  Soluble in water, sparingly soluble in ethanol, practically insoluble 
in ether  
Description  Odourless, colourless or white crystals or powder  
Identification  
Test for ribose  Passes test  
Test for organic phosphate  Passes test  
Test for sodium  Passes test  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 232
 
pH Between 7,0 and 8,5  
Spectrometry  Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm  
Purity  
Water content  Not more than 28,5 % (Karl Fischer)  
Other nucleotides  Not detectable by thin-layer chromatography  
Lead  Not more than 1 mg/kg  
E 632 DIPOTASSIUM INOSINATE 
Synonyms  Potassium inosinate; Potassium 5'-inosinate  
Definition  
Einecs  243-652-3  
Chemical name  Dipotassium inosine-5'-monophosphate  
Chemical formula  C  10 H 11 K 2 N 4 O 8 P 
Molecular weight  424,39  
Assay  Content not less than 97,0 % on the anhydrous basis  
Solubility  Freely soluble in water; practically insoluble in ethanol  
Description  Odourless, colourless or white crystals or powder  
Identification  
Test for ribose  Passes test  
Test for organic phosphate  Passes test  
Test for potassium  Passes test  
pH Between 7,0 and 8,5 (5 % solution)  
Spectrometry  Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm  
Purity  
Water content  Not more than 10,0 % (Karl Fischer)  
Other nucleotides  Not detectable by thin-layer chromatography  
Lead  Not more than 1 mg/kg  
E 633 CALCIUM INOSINATE 
Synonyms  Calcium 5'-inosinate  
Definition  
Einecs  
Chemical name  Calcium inosine-5'-monophosphate  
Chemical formula  C  10 H 11 CaN  4 O 8 P · nH  2 O 
Molecular weight  386,19 (anhydrous)  
Assay  Content not less than 97,0 % on the anhydrous basis  
Solubility  Sparingly soluble in water  
Description  Odourless, colourless or white crystals or powder  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 233
 
Identification  
Test for ribose  Passes test  
Test for organic phosphate  Passes test  
Test for calcium  Passes test  
pH Between 7,0 and 8,0 (0,05 % solution)  
Spectrometry  Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm  
Purity  
Water content  Not more than 23,0 % (Karl Fischer)  
Other nucleotides  Not detectable by thin-layer chromatography  
Lead  Not more than 1 mg/kg  
E 634 CALCIUM 5'-RIBONUCLEOTIDE 
Synonyms  
Definition  
Einecs  
Chemical name  Calcium 5 ′-ribonucleotide is essentially a mixture of calcium 
inosine-5′-monophosphate and calcium guanosine-5 ′-monophosphate  
Chemical formula  C  10 H 11 N 4 CaO  8 P · nH  2 O 
C 10 H 12 N 5 CaO  8 P · nH  2 O 
Molecular weight  
Assay  Content of both major components not less than 97,0 %, and of each 
component not less than 47,0 % and not more than 53 %, in every 
case on the anhydrous basis  
Solubility  Sparingly soluble in water  
Description  Odourless, white or nearly white crystals or powder  
Identification  
Test for ribose  Passes test  
Test for organic phosphate  Passes test  
Test for calcium  Passes test  
pH Between 7,0 and 8,0 (0,05 % solution)  
Purity  
Water content  Not more than 23,0 % (Karl Fischer)  
Other nucleotides  Not detectable by thin-layer chromatography  
Lead  Not more than 1 mg/kg  
E 635 DISODIUM 5'-RIBONUCLEOTIDE 
Synonyms  Sodium 5'-ribonucleotide  
Definition  
Einecs  
Chemical name  Disodium 5'-ribonucleotide is essentially a mixture of disodium 
inosine-5'-monophosphate and disodium guanosine-5'-monophos ­
phate  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 234
 
Chemical formula  C  10 H 11 N 4 O 8 P · nH  2 O 
C 10 H 12 N 5 Na 2 O 8 P · nH  2 O 
Molecular weight  
Assay  Content of both major components not less than 97,0 %, and of each 
component not less than 47,0 % and not more than 53 %, in every 
case on the anhydrous basis  
Solubility  Soluble in water, sparingly soluble in ethanol practically insoluble in 
ether  
Description  Odourless, white or nearly white crystals or powder  
Identification  
Test for ribose  Passes test  
Test for organic phosphate  Passes test  
Test for sodium  Passes test  
pH Between 7,0 and 8,5 (5 % solution)  
Purity  
Water content  Not more than 26,0 % (Karl Fischer)  
Other nucleotides  Not detectable by thin-layer chromatography  
Lead  Not more than 1 mg/kg  
E 640 GLYCINE AND ITS SODIUM SALT  
(i) GLYCINE  
Synonyms  Aminoacetic acid; Glycocoll  
Definition  
Einecs  200-272-2  
Chemical name  Aminoacetic acid  
Chemical formula  C  2 H 5 NO  2 
Molecular weight  75,07  
Assay  Content not less than 98,5 % on the anhydrous basis  
Description  White crystals or crystalline powder  
Identification  
Test for amino acid  Passes test  
Purity  
Loss on drying  Not more than 0,2 % (105 °C, 3 hours)  
Residue on ignition  Not more than 0,1 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
(ii) SODIUM GLYCINATE  
Synonyms  
Definition  
Einecs  227-842-3  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 235
 
Chemical name  Sodium glycinate  
Chemical formula  C  2 H 5 NO  2 Na 
Molecular weight  98  
Assay  Content not less than 98,5 % on the anhydrous basis  
Description  White crystals or crystalline powder  
Identification  
Test for amino acid  Passes test  
Test for sodium  Passes test  
Purity  
Loss on drying  Not more than 0,2 % (105 °C, 3 hours)  
Residue on ignition  Not more than 0,1 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
E 650 ZINC ACETATE 
Synonyms  Acetic acid, zinc salt, dihydrate  
Definition  
Einecs  
Chemical name  Zinc acetate dihydrate  
Chemical formula  C  4 H 6 O 4 Zn · 2H  2 O 
Molecular weight  219,51  
Assay  Content not less than 98 % and not more than 102 % of C  4 H 6 O 4 Zn 
· 2H  2 O 
Description  Colourless crystals or fine, off-white powder  
Identification  
Test for acetate  Passes test  
Test for zinc  Passes test  
pH Between 6,0 and 8,0 (5 % solution)  
Purity  
Water insoluble matter  Not more than 0,005 %  
Chlorides  Not more than 50 mg/kg  
Sulphates  Not more than 100 mg/kg  
Alkalines and alkaline earths  Not more than 0,2 %  
Organic volatile impurities  Passes test  
Iron Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 20 mg/kg  
Cadmium  Not more than 5 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 236
 
E 900 DIMETHYL POLYSILOXANE 
Synonyms  Polydimethyl siloxane; Silicone fluid; Silicone oil; Dimethyl silicone  
Definition  Dimethylpolysiloxane is a mixture of fully methylated linear 
siloxane polymers containing repeating units of the formula (CH  3 ) 2 
SiO and stabilised with trimethylsiloxy end-blocking units of the 
formula (CH  3 ) 3 SiO 
Einecs  
Chemical name  Siloxanes and silicones, di-methyl  
Chemical formula  (CH  3 ) 3 -Si-[O-Si(CH  3 ) 2 ] n -O-Si(CH  3 ) 3 
Molecular weight  
Assay  Content of total silicon not less than 37,3 % and not more than 
38,5 %  
Description  Clear, colourless, viscous liquid  
Identification  
Specific gravity (25° C/25 °C)  Between 0,964 and 0,977  
Refractive index  [n]  D 25 between 1,400 and 1,405  
Infrared absorption spectrum  The infrared absorption spectrum of a liquid film of the sample 
between two sodium chloride plates exhibits relative maxima at 
the same wavelengths as those of a similar preparation of Dimethyl ­
polysiloxane Reference Standard  
Purity  
Loss on drying  Not more than 0,5 % (150 °C, 4h)  
Viscosity  Not less than 1,00 · 10 – 4 m 2 s – 1 at 25 °C  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 901 BEESWAX, WHITE AND YELLOW 
Synonyms  White wax; Yellow wax  
Definition  Yellow bees wax is the wax obtained by melting the walls of the 
honeycomb made by the honey bee,  Apis mellifera  L., with hot 
water and removing foreign matter 
White beeswax is obtained by bleaching yellow beeswax  
Einecs  232-383-7  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Yellowish white (white form) or yellowish to greyish brown (yellow 
form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour
 
Identification  
Melting range  Between 62 °C and 65 °C  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 237
 
Specific gravity  About 0,96  
Solubility  Insoluble in water, sparingly soluble in alcohol, very soluble in 
chloroform and ether  
Purity  
Acid value  Not less than 17 and not more than 24  
Saponification value  87-104  
Peroxide value  Not more than 5  
Glycerol and other polyols  Not more than 0,5 % (as glycerol)  
Ceresin, paraffins and certain other 
waxes  Transfer 3,0 g of the sample to a 100 ml round-bottomed flask, add 
30 ml of a 4% w/v solution of potassium hydroxide in aldehyde-free 
ethanol and boil gently under a reflux condenser for 2 h. Remove the condenser and immediately insert a thermometer. Place the flask in water at 80 °C and allow to cool, swirling the solution continu ­
ously. No precipitate is formed before the temperature reaches 
65 °C, although the solution may be opalescent.
 
Fats, Japan wax, rosin and soaps  Boil 1 g of the sample for 30 min with 35 ml of a 1 in 7 solution of 
sodium hydroxide, maintaining the volume by the occasional 
addition of water, and cool the mixture. The wax separates and 
the liquid remains clear. Filter the cold mixture and acidify the filtrate with hydrochloric acid. No precipitate is formed.
 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 902 CANDELILLA WAX 
Synonyms  
Definition  Candelilla wax is a purified wax obtained from the leaves of the 
candelilla plant,  Euphorbia antisyphilitica  
Einecs  232-347-0  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Hard, yellowish brown, opaque to translucent wax  
Identification  
Specific gravity  About 0,98  
Melting range  Between 68,5 °C and 72,5 °C  
Solubility  Insoluble in water, soluble in chloroform and toluene  
Purity  
Acid value  Not less than 12 and not more than 22  
Saponification value  Not less than 43 and not more than 65  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 238
 
E 903 CARNAUBA WAX 
Synonyms  
Definition  Carnauba wax is a purified wax obtained from the leaf buds and 
leaves of the Brazilian Mart wax palm,  Copernicia cerifera  
Einecs  232-399-4  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Light brown to pale yellow powder or flakes or hard and brittle solid 
with a resinous fracture  
Identification  
Specific gravity  About 0,997  
Melting range  Between 82 °C and 86 °C  
Solubility  Insoluble in water, partly soluble in boiling ethanol, soluble in 
chloroform and diethyl ether  
Purity  
Sulphated ash  Not more than 0,25 %  
Acid value  Not less than 2 and not more than 7  
Ester value  Not less than 71 and not more than 88  
Unsaponifiable matter  Not less than 50 % and not more than 55 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 904 SHELLAC 
Synonyms  Bleached shellac; White shellac  
Definition  Shellac is the purified and bleached lac, the resinous secretion of the 
insect  Laccifer (Tachardia) lacca  Kerr (Fam.  Coccidae ) 
Einecs  232-549-9  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Bleached shellac — off-white, amorphous, granular resin 
Wax-free bleached shellac — light yellow, amorphous, granular 
resin  
Identification  
Solubility  Insoluble in water; freely (though very slowly) soluble in alcohol; 
slightly soluble in acetone  
Acid value  Between 60 and 89  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 239
 
Purity  
Loss on drying  Not more than 6,0 % (40 °C, over silica gel, 15 hours)  
Rosin  Absent  
Wax  Bleached shellac: not more than 5,5 % 
Wax-free bleached shellac: not more than 0,2 %  
Lead  Not more than 2 mg/kg  
E 905 MICROCRYSTALLINE WAX 
Synonyms  Petroleum wax; Hydrocarbon wax; Fischer-Tropsch wax; Synthetic 
wax; Synthetic paraffin  
Definition  Refined mixtures of solid, saturated hydrocarbons, obtained from 
petroleum or synthetic feedstocks  
Description  White to amber, odourless wax  
Identification  
Solubility  Insoluble in water, very slightly soluble in ethanol  
Refractive index  [n]  D 100 1,434-1,448 
Alternative [n]  D 120 1,426-1,440  
Purity  
Molecular weight  Average not less than 500  
Viscosity  Not less than 1,1 × 10  – 5 m 2 s – 1 at 100 °C 
Alternative: Not less than 0,8 × 10  – 5 m 2 s – 1 at 120 °C, if solid at 
100 °C  
Residue on ignition  Not more than 0,1 %  
Carbon number at 5 % distillation point  Not more than 5 % of molecules with carbon number less than 25  
Colour  Passes test  
Sulphur  Not more than 0,4 wt %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 3 mg/kg  
Polycyclic aromatic compounds  Benzo(a)pyrene no more than 50 μg/kg 
E 907 HYDROGENATED POLY-1-DECENE 
Synonyms  Hydrogenated polydec-1-ene; Hydrogenated poly-alpha-olefin  
Definition  
Einecs  
Chemical name  
Chemical formula  C  10n H 20n+2  where n = 3-6  
Molecular weight  560 (average)  
Assay  Not less than 98,5 % of hydrogenated poly-1-decene, having the 
following oligomer distribution: 
C 30 : 13-37 % 
C 40 : 35-70 % 
C 50 : 9-25 % 
C 60 : 1-7 %  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 240
 
Description  
Identification  
Solubility  Insoluble in water; slightly soluble in ethanol; soluble in toluene  
Burning  Burns with a bright flame and a paraffin-like characteristic smell  
Viscosity  Between 5,7 × 10  – 6 and 6,1 × 10  – 6 m 2 s – 1 at 100 °C  
Purity  
Compounds with carbon number less 
than 30  Not more than 1,5 %  
Readily carbonisable substances  After 10 minutes shaking in a boiling water bath, a tube of sulphuric 
acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour
 
Nickel  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
E 912 MONTAN ACID ESTERS 
Synonyms  
Definition  Montan acids and/or esters with ethylene glycol and/or 1,3- 
butanediol and/or glycerol  
Einecs  
Chemical name  Montan acid esters  
Chemical formula  
Molecular weight  
Assay  
Description  Almost white to yellowish flakes, powder, granules or pellets  
Identification  
Density  Between 0,98 and 1,05 (20 °C)  
Drop point  Greater than 77 °C  
Purity  
Acid value  Not more than 40  
Glycerol  Not more than 1 % (by gas chromatography)  
Other polyols  Not more than 1 % (by gas chromatography)  
Other wax types  Not detectable (by differential scanning calorimetry and/or infrared 
spectroscopy)  
Arsenic  Not more than 2 mg/kg  
Chromium  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
E 914 OXIDISED POLYETHYLENE WAX 
Synonyms  
Definition  Polar reaction products from mild oxidation of polyethylene  
Einecs  
Chemical name  Oxidised polyethylene  
Chemical formula  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 241
 
Molecular weight  
Assay  
Description  Almost white flakes, powder, granules or pellets  
Identification  
Density  Between 0,92 and 1,05 (20 °C)  
Drop point  Greater than 95 °C  
Purity  
Acid value  Not more than 70  
Viscosity  Not less than 8,1 · 10 – 5 m 2 s – 1 at 120 °C  
Other wax types  Not detectable (by differential scanning calorimetry and/or infrared 
spectroscopy)  
Oxygen  Not more than 9,5 %  
Chromium  Not more than 5 mg/kg  
Lead  Not more than 2 mg/kg  
E 920 L-CYSTEINE 
Synonyms  
Definition  L-cysteine hydrochloride or hydrochloride monohydrate. Human hair 
may not be used as a source for this substance  
Einecs  200-157-7 (anhydrous)  
Chemical name  
Chemical formula  C  3 H 7 NO  2 S · HCl · nH  2 O (where n = 0 or 1)  
Molecular weight  157,62 (anhydrous)  
Assay  Content not less than 98,0 % and not more than 101,5 % on the 
anhydrous basis  
Description  White powder or colourless crystals  
Identification  
Solubility  Freely soluble in water and in ethanol  
Melting range  Anhydrous form melts at about 175 °C  
Specific rotation  [ α] D 20 : between + 5,0° and + 8,0° or 
[α] D 25 : between + 4,9° and 7,9°  
Purity  
Loss on drying  Between 8,0 % and 12,0 % 
Not more than 2,0 % (anhydrous form)  
Residue on ignition  Not more than 0,1 %  
Ammonium-ion  Not more than 200 mg/kg  
Arsenic  Not more than 1,5 mg/kg  
Lead  Not more than 5 mg/kg  
E 927b CARBAMIDE 
Synonyms  Urea  
Definition  
Einecs  200-315-5  
Chemical name  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 242
 
Chemical formula  CH  4 N 2 O 
Molecular weight  60,06  
Assay  Content not less than 99,0 % on the anhydrous basis  
Description  Colourless to white, prismatic, crystalline powder or small, white 
pellets  
Identification  
Solubility  Very soluble in water 
Soluble in ethanol  
Precipitation with nitric acid  To pass the test a white, crystalline precipitate is formed  
Colour reaction  To pass the test a reddish-violet colour is produced  
Melting range  132 °C to 135 °C  
Purity  
Loss on drying  Not more than 1,0 % (105 °C, 1 hour)  
Sulphated ash  Not more than 0,1 %  
Ethanol-insoluble matter  Not more than 0,04 %  
Alkalinity  Passes test  
Ammonium-ion  Not more than 500 mg/kg  
Biuret  Not more than 0,1 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
E 938 ARGON 
Synonyms  
Definition  
Einecs  231-147-0  
Chemical name  Argon  
Chemical formula  Ar  
Atomic weight  40  
Assay  Not less than 99 %  
Description  Colourless, odourless, non-flammable gas  
Identification  
Purity  
Water content  Not more than 0,05 %  
Methane and other hydrocarbons  Not more than 100 μl/l (calculated as methane)  
E 939 HELIUM 
Synonyms  
Definition  
Einecs  231-168-5  
Chemical name  Helium  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 243
 
Chemical formula  He  
Atomic weight  4  
Assay  Not less than 99 %  
Description  Colourless, odourless, non-flammable gas  
Identification  
Purity  
Water content  Not more than 0,05 %  
Methane and other hydrocarbons  Not more than 100 μl/l (calculated as methane)  
E 941 NITROGEN 
Synonyms  
Definition  
Einecs  231-783-9  
Chemical name  Nitrogen  
Chemical formula  N  2 
Molecular weight  28  
Assay  Not less than 99 %  
Description  Colourless, odourless, non-flammable gas  
Identification  
Purity  
Water content  Not more than 0,05 %  
Carbon monoxide  Not more than 10 μl/l 
Methane and other hydrocarbons  Not more than 100 μl/l (calculated as methane)  
Nitrogen dioxide and nitrogen oxide  Not more than 10 μl/l 
Oxygen  Not more than 1 %  
E 942 NITROUS OXIDE 
Synonyms  
Definition  
Einecs  233-032-0  
Chemical name  Nitrous oxide  
Chemical formula  N  2 O 
Molecular weight  44  
Assay  Not less than 99 %  
Description  Colourless, non-flammable gas, sweetish odour  
Identification  
Purity  
Water content  Not more than 0,05 %  
Carbon monoxide  Not more than 30 μl/l 
Nitrogen dioxide and nitrogen oxide  Not more than 10 μl/l ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 244
 
E 943a BUTANE 
Synonyms  n-Butane  
Definition  
Einecs  
Chemical name  Butane  
Chemical formula  CH  3 CH 2 CH 2 CH 3 
Molecular weight  58,12  
Assay  Content not less than 96 %  
Description  Colourless gas or liquid with mild, characteristic odour  
Identification  
Vapour pressure  108,935 kPa at 20 °C  
Purity  
Methane  Not more than 0,15 % v/v  
Ethane  Not more than 0,5 % v/v  
Propane  Not more than 1,5 % v/v  
Isobutane  Not more than 3,0 % v/v  
1,3-butadiene  Not more than 0,1 % v/v  
Moisture  Not more than 0,005 %  
E 943b ISOBUTANE 
Synonyms  2-Methyl propane  
Definition  
Einecs  
Chemical name  2-methyl propane  
Chemical formula  (CH  3 ) 2 CH CH  3 
Molecular weight  58,12  
Assay  Content not less than 94 %  
Description  Colourless gas or liquid with mild, characteristic odour  
Identification  
Vapour pressure  205,465 kPa at 20 °C  
Purity  
Methane  Not more than 0,15 % v/v  
Ethane  Not more than 0,5 % v/v  
Propane  Not more than 2,0 % v/v  
n-Butane  Not more than 4,0 % v/v  
1,3-butadiene  Not more than 0,1 % v/v  
Moisture  Not more than 0,005 %  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 245
 
E 944 PROPANE 
Synonyms  
Definition  
Einecs  
Chemical name  Propane  
Chemical formula  CH  3 CH 2 CH 3 
Molecular weight  44,09  
Assay  Content not less than 95 %  
Description  Colourless gas or liquid with mild, characteristic odour  
Identification  
Vapour pressure  732,910 kPa at 20 °C  
Purity  
Methane  Not more than 0,15 % v/v  
Ethane  Not more than 1,5 % v/v  
Isobutane  Not more than 2,0 % v/v  
n-Butane  Not more than 1,0 % v/v  
1,3-butadiene  Not more than 0,1 % v/v  
Moisture  Not more than 0,005 %  
E 948 OXYGEN 
Synonyms  
Definition  
Einecs  231-956-9  
Chemical name  Oxygen  
Chemical formula  O  2 
Molecular weight  32  
Assay  Not less than 99 %  
Description  Colourless, odourless, non-flammable gas  
Identification  
Purity  
Water content  Not more than 0,05 %  
Methane and other hydrocarbons  Not more than 100 μl/l (calculated as methane)  
E 949 HYDROGEN 
Synonyms  
Definition  
Einecs  215-605-7  
Chemical name  Hydrogen  
Chemical formula  H  2 
Molecular weight  2  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 246
 
Assay  Content not less than 99,9 %  
Description  Colourless, odourless, highly flammable gas  
Identification  
Purity  
Water content  Not more than 0,005 % v/v  
Oxygen  Not more than 0,001 % v/v  
Nitrogen  Not more than 0,07 % v/v  
E 950 ACESULFAME K 
Synonyms  Acesulfame potassium; Potassium salt of 3,4-dihydro-6-methyl- 
1,2,3-oxathiazin-4-one-2,2-dioxide  
Definition  
Einecs  259-715-3  
Chemical name  6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt  
Chemical formula  C  4 H 4 KNO  4 S 
Molecular weight  201,24  
Assay  Content not less than 99 % of C  4 H 4 KNO  4 S on the anhydrous basis  
Description  Odourless, white, crystalline powder. Approximately 200 times as 
sweet as sucrose  
Identification  
Solubility  Very soluble in water, very slightly soluble in ethanol  
Ultraviolet absorption  Maximum 227 ± 2 nm for a solution of 10 mg in 1 000 ml of water  
Test for potassium  Passes test (test the residue obtained by igniting 2 g of the sample)  
Precipitation test  Add a few drops of a 10 % solution of sodium cobaltnitrite to a 
solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced
 
Purity  
Loss on drying  Not more than 1 % (105 °C, 2 hours)  
Organic impurities  Passes test for 20 mg/kg of UV active components  
Fluoride  Not more than 3 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
E 951 ASPARTAME 
Synonyms  Aspartyl phenylalanine methyl ester  
Definition  
Einecs  245-261-3  
Chemical name  N-L- α-Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-( α- 
carbomethoxy-phenethyl)-succinamic acid-N-methyl ester  
Chemical formula  C  14 H 18 N 2 O 5 
Molecular weight  294,31  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 247
 
Assay  Not less than 98 % and not more than 102 % of C  14 H 18 N 2 O 5 on the 
anhydrous basis  
Description  White, odourless, crystalline powder having a sweet taste. Approxi ­
mately 200 times as sweet as sucrose  
Identification  
Solubility  Slightly soluble in water and in ethanol  
pH Between 4,5 and 6,0 (1 in 125 solution)  
Specific rotation  [ α] D 20 : + 14,5° to + 16,5° 
Determine in a 4 in 100/15 N formic acid solution within 30 minutes 
after preparation of the sample solution  
Purity  
Loss on drying  Not more than 4,5 % (105 °C, 4 hours)  
Sulphated ash  Not more than 0,2 % (expressed on dry weight basis)  
Transmittance  The transmittance of a 1 % solution in 2N hydrochloric acid, 
determined in a 1-cm cell at 430 nm with a suitable spectrophoto ­
meter, using 2N hydrochloric acid as a reference, is not less than 
0,95, equivalent to an absorbance of not more than approximately 0,022
 
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
5-Benzyl-3,6-dioxo-2-piperazineacetic 
acid Not more than 1,5 % (expressed on dry weight basis)  
E 952 CYCLAMIC ACID AND ITS Na AND Ca SALTS  
(i) CYCLAMIC ACID  
Synonyms  Cyclohexylsulphamic acid; Cyclamate  
Definition  
Einecs  202-898-1  
Chemical name  Cyclohexanesulphamic acid; cyclohexylaminosulphonic acid  
Chemical formula  C  6 H 13 NO  3 S 
Molecular weight  179,24  
Assay  Cyclohexylsulphamic acid contains not less than 98 % and not more 
than the equivalent of 102 % of C  6 H 13 NO  3 S, calculated on the 
anhydrous basis  
Description  A practically colourless, white crystalline powder. Approximately 40 
times as sweet as sucrose  
Identification  
Solubility  Soluble in water and in ethanol  
Precipitation test  Acidify a 2 % solution with hydrochloric acid, add 1 ml of an 
approximately molar solution of barium chloride in water and 
filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms.
 
Purity  
Loss on drying  Not more than 1 % (105 °C, 1 hour)  
Selenium  Not more than 30 mg/kg (expressed as selenium on dry weight 
basis)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 248
 
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Cyclohexylamine  Not more than 10 mg/kg (expressed on dry weight basis)  
Dicyclohexylamine  Not more than 1 mg/kg (expressed on dry weight basis)  
Aniline  Not more than 1 mg/kg (expressed on dry weight basis)  
(ii) SODIUM CYCLAMATE  
Synonyms  Cyclamate; Sodium salt of cyclamic acid  
Definition  
Einecs  205-348-9  
Chemical name  Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate  
Chemical formula  C  6 H 12 NNaO  3 S and the dihydrate form C  6 H 12 NNaO  3 S·2H 2 O 
Molecular weight  201,22 calculated on the anhydrous form 
237,22 calculated on the hydrated form  
Assay  Not less than 98 % and not more than 102 % on the dried basis 
Dihydrate form: not less than 84 % on the dried basis  
Description  White, odourless crystals or crystalline powder. Approximately 30 
times as sweet as sucrose  
Identification  
Solubility  Soluble in water, practically insoluble in ethanol  
Purity  
Loss on drying  Not more than 1 % (105 °C, 1 hour) 
Not more than 15,2 % (105 °C, 2 hours) for the dihydrate form  
Selenium  Not more than 30 mg/kg (expressed as selenium on dry weight 
basis)  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
Cyclohexylamine  Not more than 10 mg/kg (expressed on dry weight basis)  
Dicyclohexylamine  Not more than 1 mg/kg (expressed on dry weight basis)  
Aniline  Not more than 1 mg/kg (expressed on dry weight basis)  
(iii) CALCIUM CYCLAMATE  
Synonyms  Cyclamate; Calcium salt of cyclamic acid  
Definition  
Einecs  205-349-4  
Chemical name  Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate  
Chemical formula  C  12 H 24 CaN  2 O 6 S 2 · 2H  2 O 
Molecular weight  432,57  
Assay  Not less than 98 % and not more than 101 % on the dried basis  
Description  White, colourless crystals or crystalline powder. Approximately 30 
times as sweet as sucrose  
Identification  
Solubility  Soluble in water, sparingly soluble in ethanol  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 249
 
Purity  
Loss on drying  Not more than 1 % (105 °C, 1 hour) 
Not more than 8,5 % (140 °C, 4 hours) for the dihydrate form  
Selenium  Not more than 30 mg/kg (expressed as selenium on dry weight 
basis)  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
Cyclohexylamine  Not more than 10 mg/kg (expressed on dry weight basis)  
Dicyclohexylamine  Not more than 1 mg/kg (expressed on dry weight basis)  
Aniline  Not more than 1 mg/kg (expressed on dry weight basis)  
E 953 ISOMALT 
Synonyms  Hydrogenated isomaltulose.  
Definition  Manufactured by enzymatic conversion of sucrose with nonviable 
cells of  Protaminobacter rubrum  followed by catalytic hydroge ­
nation  
Einecs  
Chemical name  Isomalt is a mixture of hydrogenated mono- and disaccharides whose 
principal components are the disaccharides: 
6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and 
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)  
Chemical formula  6-O- α-D-Glucopyranosyl-D-sorbitol: C  12 H 24 O 11 
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C  12 H 24 O 11 .2H  2 O 
Molecular weight  6-O- α-D-Glucopyranosyl-D-sorbitol: 344,3 
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,3  
Assay  Content not less than 98 % of hydrogenated mono- and 
disaccharides and not less than 86 % of the mixture of 6-O- α-D- 
Glucopyranosyl-D-sorbitol and 1-O- α-D-Glucopyranosyl-D-mannitol 
dihydrate determined on the anhydrous basis.  
▼M4 
Description  Odourless, white, slightly hygroscopic, crystalline mass or aqueous 
solution with a minimum concentration of 60 %  
▼B 
Identification  
Solubility  Soluble in water, very slightly soluble in ethanol.  
HPLC test  Comparison with an appropriate reference standard of Isomalt shows 
that the 2 principal peaks in the chromatogram of the test solution are similar in retention time to the 2 principal peaks in the chroma ­
togram obtained with the reference solution.
 
▼M4 
Purity  
Water content  Not more than 7 % for solid product (Karl Fischer Method)  
Conductivity  Not more than 20 μS/cm (on 20 % dry solids solution) at 
temperature 20 °C  
D-Mannitol  Not more than 3 %  
D-Sorbitol  Not more than 6 %  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 250
 
Reducing sugars  Not more than 0,3 % (expressed as glucose on dry weight basis)  
Nickel  Not more than 2 mg/kg (expressed on dry weight basis)  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
▼B 
E 954 SACCHARIN AND ITS Na. K AND Ca SALTS  
(i) SACCHARIN  
Synonyms  
Definition  
Einecs  201-321-0  
Chemical name  3-Oxo-2,3dihydrobenzo(d)isothiazol-1,1-dioxide  
Chemical formula  C  7 H 5 NO  3 S 
Molecular weight  183,18  
Assay  Not less than 99 % and not more than 101 % of C  7 H 5 NO  3 S on the 
anhydrous basis  
Description  White crystals or a white crystalline powder, odourless or with a 
faint, aromatic odour. Approximately between 300 and 500 times as 
sweet as sucrose  
Identification  
Solubility  Slightly soluble in water, soluble in basic solutions, sparingly soluble 
in ethanol  
Purity  
Loss on drying  Not more than 1 % (105 °C, 2 hours)  
Melting range  226 to 230 °C  
Sulphated ash  Not more than 0,2 % (expressed on dry weight basis)  
Benzoic and salicylic acid  To 10 ml of a 1 in 20 solution, previously acidified with five drops 
of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
 
o-Toluenesulphonamide  Not more than 10 mg/kg (expressed on dry weight basis)  
p-Toluenesulphonamide  Not more than 10 mg/kg (expressed on dry weight basis)  
Benzoic acid  p-sulphonamide  Not more than 25 mg/kg (expressed on dry weight basis)  
Readily carbonisable substances  Absent  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Selenium  Not more than 30 mg/kg (expressed on dry weight basis)  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
(ii) SODIUM SACCHARIN  
Synonyms  Saccharin; Sodium salt of saccharin  
Definition  
Einecs  204-886-1  
Chemical name  Sodium o-benzosulphimide; sodium salt of 2,3-dihydro-3-oxobenzi ­
sosulphonazole; oxobenzisosulphonazole; 1,2-benzisothiazolin-3- one-1, 1-dioxide sodium salt dihydrate
 ▼M4 2012R0231 — EN — 11.07.2014 — 008.001 — 251
 
Chemical formula  C  7 H 4 NNaO  3 S·2H 2 O 
Molecular weight  241,19  
Assay  Not less than 99 % and not more than 101 % of C  7 H 4 NNaO  3 S on 
the anhydrous basis  
Description  White crystals or a white crystalline efflorescent powder, odourless 
or with a faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
 
Identification  
Solubility  Freely soluble in water, sparingly soluble in ethanol  
Purity  
Loss on drying  Not more than 15 % (120 °C, 4 hours)  
Benzoic and salicylic acid  To 10 ml of a 1 in 20 solution, previously acidified with five drops 
of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
 
o-Toluenesulphonamide  Not more than 10 mg/kg (expressed on dry weight basis)  
p-Toluenesulphonamide  Not more than 10 mg/kg (expressed on dry weight basis)  
Benzoic acid  p-sulphonamide  Not more than 25 mg/kg (expressed on dry weight basis)  
Readily carbonisable substances  Absent  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Selenium  Not more than 30 mg/kg (expressed on dry weight basis)  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
(iii) CALCIUM SACCHARIN  
Synonyms  Saccharin; Calcium salt of saccharin  
Definition  
Chemical name  Calcium o-benzosulphimide; calcium salt of 2,3-dihydro-3-oxoben ­
zisosulphonazole; 1,2-benzisothiazolin-3-one-1,1-dioxide calcium 
salt hydrate (2:7)  
Einecs  229-349-9  
Chemical formula  C  14 H 8 CaN  2 O 6 S 2 ·3½H  2 O 
Molecular weight  467,48  
Assay  Not less than 95 % of C  14 H 8 CaN  2 O 6 S 2 on the anhydrous basis  
Description  White crystals or a white crystalline powder, odourless or with a 
faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
 
Identification  
Solubility  Freely soluble in water, soluble in ethanol  
Purity  
Loss on drying  Not more than 13,5 % (120 °C, 4 hours)  
Benzoic and salicylic acid  To 10 ml of a 1 in 20 solution, previously acidified with five drops 
of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 252
 
o-Toluenesulphonamide  Not more than 10 mg/kg expressed (on dry weight basis)  
p-Toluenesulphonamide  Not more than 10 mg/kg expressed (on dry weight basis)  
Benzoic acid  p-sulphonamide  Not more than 25 mg/kg expressed (on dry weight basis)  
Readily carbonisable substances  Absent  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Selenium  Not more than 30 mg/kg (expressed on dry weight basis)  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
(iv) POTASSIUM SACCHARIN  
Synonyms  Saccharin; Potassium salt of saccharin  
Definition  
Einecs  
Chemical name  Potassium o-benzosulphimide; potassium salt of 2,3-dihydro-3- 
oxobenzisosulphonazole; potassium salt of 1,2-benzisothiazolin-3- 
one-1,1-dioxide monohydrate  
Chemical formula  C  7 H 4 KNO  3 S·H 2 O 
Molecular weight  239,77  
Assay  Not less than 99 % and not more than 101 % of C  7 H 4 KNO  3 S on the 
anhydrous basis  
Description  White crystals or a white crystalline powder, odourless or with a 
faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose
 
Identification  
Solubility  Freely soluble in water, sparingly soluble in ethanol  
Purity  
Loss on drying  Not more than 8 % (120 °C, 4 hours)  
Benzoic and salicylic acid  To 10 ml of a 1 in 20 solution, previously acidified with five drops 
of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
 
o-Toluenesulphonamide  Not more than 10 mg/kg (expressed on dry weight basis)  
p-Toluenesulphonamide  Not more than 10 mg/kg (expressed on dry weight basis)  
Benzoic acid  p-sulphonamide  Not more than 25 mg/kg (expressed on dry weight basis)  
Readily carbonisable substances  Absent  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Selenium  Not more than 30 mg/kg (expressed on dry weight basis)  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
E 955 SUCRALOSE 
Synonyms  4,1’,6’-Trichlorogalactosucrose  
Definition  
Einecs  259-952-2  
Chemical name  1,6-Dichloro-1,6-dideoxy- β-D-fructofuranosyl-4-chloro-4-deoxy- α-D- 
galactopyranoside  
Chemical formula  C  12 H 19 Cl 3 O 8 
Molecular weight  397,64  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 253
 
Assay  Content not less than 98 % and not more than 102 % C  12 H 19 Cl 3 O 8 
calculated on an anhydrous basis.  
Description  White to off-white, practically odourless, crystalline powder.  
Identification  
Solubility  Freely soluble in water, methanol and ethanol 
Slightly soluble in ethyl acetate  
Infrared absorption spectrum  The infrared spectrum of a potassium bromide dispersion of the 
sample exhibits relative maxima at similar wave numbers as those 
shown in the reference spectrum obtained using a sucralose reference standard.
 
Thin layer chromatography  The main spot in the test solution has the same Rf value as that of 
the main spot of standard solution A referred to in the test for other chlorinated disaccharides. This standard solution is obtained by dissolving 1,0g of sucralose reference standard in 10 ml of methanol.
 
Specific rotation  [ α] D 20 + 84,0° to + 87,5° calculated on the anhydrous basis (10 % 
w/v solution)  
Purity  
Water content  Not more than 2,0 % (Karl Fischer method)  
Sulphated ash  Not more than 0,7 %  
Other chlorinated disaccharides  Not more than 0,5 %  
Chlorinated monosaccharides  Not more than 0,1 %  
Triphenylphosphine oxide  Not more than 150 mg/kg  
Methanol  Not more than 0,1 %  
Lead  Not more than 1 mg/kg  
E 957 THAUMATIN 
Synonyms  
Definition  
Einecs  258-822-2  
Chemical name  Thaumatin is obtained by aqueous extraction (pH 2,5 to 4) of the 
arils of the fruit of strains of  Thaumatococcus daniellii  (Benth) and 
consists essentially of the proteins thaumatin I and thaumatin II 
together with minor amounts of plant constituents derived from the source material
 
Chemical formula  Polypeptide of 207 amino acids  
Molecular weight  Thaumatin I 22209 
Thaumatin II 22293  
Assay  Not less than 15,1 % nitrogen on the dried basis equivalent to not 
less than 93 % proteins (N × 6,2)  
Description  Odourless, cream-coloured powder. Approximately 2 000 to 3 000 
times as sweet as sucrose  
Identification  
Solubility  Very soluble in water, insoluble in acetone  
Purity  
Loss on drying  Not more than 9 % (105 °C to constant weight)  
Carbohydrates  Not more than 3 % (expressed on dry weight basis)  
Sulphated ash  Not more than 2 % (expressed on dry weight basis)  
Aluminium  Not more than 100 mg/kg (expressed on dry weight basis)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 254
 
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Lead  Not more than 3 mg/kg (expressed on dry weight basis)  
Microbiological criteria  
Total aerobic microbial count  Not more than 1 000 colonies per gram  
Escherichia coli  Absent in 1 g  
E 959 NEOHESPERIDINE DIHYDROCHALCONE 
Synonyms  Neohesperidin dihydrochalcone; NHDC; Hesperetin dihydro ­
chalcone-4 ′-β-neohesperidoside; Neohesperidin DC  
Definition  It is obtained by catalytic hydrogenation of neohesperidin  
Einecs  243-978-6  
Chemical name  2-O- α-L-rhamnopyranosyl-4 ′-β-D-glucopyranosyl hesperetin dihy ­
drochalcone.  
Chemical formula  C  28 H 36 O 15 
Molecular weight  612,6  
Assay  Content not less than 96 % on the dried basis  
Description  Off-white, odourless, crystalline powder. Approximately between 
1 000 and 1 800 times as sweet as sucrose  
Identification  
Solubility  Freely soluble in hot water, very slightly soluble in cold water, 
practically insoluble in ether and benzene  
Ultraviolet absorption maximum  282 to 283 nm for a solution of 2 mg in 100 ml methanol  
Neu's test  Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 
1 ml of a 1 % 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is produced
 
Purity  
Loss on drying  Not more than 11 % (105 °C, 3 hours)  
Sulphated ash  Not more than 0,2 % (expressed on dry weight basis)  
Arsenic  Not more than 3 mg/kg expressed on dry weight basis  
Lead  Not more than 2 mg/kg (expressed on dry weight basis)  
E 960 STEVIOL GLYCOSIDES 
Synonyms  
Definition  The manufacturing process comprises two main phases: the first 
involving water extraction of the leaves of the  Stevia rebaudiana  
Bertoni plant and preliminary purification of the extract by 
employing ion exchange chromatography to yield a steviol 
glycoside primary extract, and the second involving recrystallisation of the steviol glycosides from methanol or aqueous ethanol resulting in a final product consisting mainly (at least 75 %) of 
stevioside and/or rebaudioside A. 
The additive may contain residues of ion-exchange resins used in 
the manufacturing process. Several other related steviol glycosides 
that may be generated as a result of the production process, but do 
not occur naturally in the  Stevia rebaudiana  plant have been 
identified in small amounts (0,10 to 0,37 % w/w).
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 255
 
Chemical name  Stevioside: 13-[(2-O- β-D-glucopyranosyl- β-D-glucopyrano ­
syl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester 
Rebaudioside A: 13-[(2-O- β-D-glucopyranosyl-3-O- β-D-glucopy ­
ranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D- 
glucopyranosyl ester  
Chemical formula  Trivial name  Formula  Conversion factor  
Steviol  C  20 H 30 O 3 1,00 
Stevioside  C  38 H 60 O 18 0,40 
Rebaudioside A  C  44 H 70 O 23 0,33 
Rebaudioside C  C  44 H 70 O 22 0,34 
Dulcoside A  C  38 H 60 O 17 0,40 
Rubusoside  C  32 H 50 O 13 0,50 
Steviolbioside  C  32 H 50 O 13 0,50 
Rebaudioside B  C  38 H 60 O 18 0,40 
Rebaudioside D  C  50 H 80 O 28 0,29 
Rebaudioside E  C  44 H 70 O 23 0,33 
Rebaudioside F  C  43 H 68 O 22 0,34 
Molecular weight and CAS No  Trivial name  CAS Number  Molecular weight  
Stevioside  57817-89-7  804,87  
Rebaudioside A  58543-16-1  967,01  
Assay  Not less than 95 % stevioside, rebaudiosides A, B, C, D, E and F, 
steviolbioside, rubusoside and dulcoside on the dried basis.  
Description  White to light yellow powder, approximately between 200 and 300 
times sweeter than sucrose  
Identification  
Solubility  Freely soluble to slightly soluble in water  
Stevioside and rebaudioside A  The main peak in the chromatogram obtained following the 
procedure in Method of Assay corresponds to either stevioside or 
rebaudioside A  
pH Between 4,5 and 7,0 (1 in 100 solution)  
Purity  
Total ash  Not more than 1 %  
Loss on drying  Not more than 6 % (105 °C, 2h)  
Residual solvents  Not more than 200 mg/kg methanol 
Not more than 5 000 mg/kg ethanol  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
E 961 NEOTAME 
Synonyms  N-[N-(3,3-dimethylbutyl)-L- α-aspartyl]-L-phenylalanine 1-methyl 
ester; 
N(3,3-dimethylbutyl)-L-aspartyl-L-phenylalanine methyl ester.  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 256
 
Definition  Neotame is manufactured by reaction under hydrogen pressure of 
aspartame with 3,3,-dimethylbutyraldehyde in methanol in presence of a palladium/carbon catalyst. It is isolated and purified by filtration, where diatomaceous earth may be used. After solvent 
removal via distillation, neotame is washed with water, isolated by 
centrifugation and finally vacuum dried.
 
CAS Nr.  165450-17-9  
Chemical name  N-[N-(3,3-dimethylbutyl)-L- α-aspartyl]-L-phenylalanine 1-methyl 
ester  
Chemical formula  C  20 H 30 N 2 O 5 
Molecular weight  378,47  
Description  white to off-white powder  
Assay  Not less than 97,0 % on the dried basis  
Identification  
Solubility  4,75 % (w/w) at 60 °C in water, soluble in ethanol and ethyl acetate  
Purity  
Water content  Not more than 5 % (Karl Fischer, sample size 25 ± 5mg)  
pH 5,0-7,0 (0,5 % aqueous solution)  
Melting range  81 °C to 84 °C  
N-[(3,3-dimethylbutyl)-L- α-aspartyl]-L- 
phenylalanine  Not more than 1,5 %  
Lead  Not more than 1 mg/kg  
E 962 SALT OF ASPARTAME-ACESULFAME 
Synonyms  Aspartame-acesulfame; Aspartame-acesulfame salt  
Definition  The salt is prepared by heating an approximately 2:1 ratio (w/w) of 
aspartame and acesulfame K in solution at acidic pH and allowing 
crystallisation to occur. The potassium and moisture are eliminated. The product is more stable than aspartame alone.
 
Einecs  
Chemical name  6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-pheny ­
lalanyl-2-methyl-L- α-aspartic acid  
Chemical formula  C  18 H 23 O 9 N 3 S 
Molecular weight  457,46  
Assay  63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37,0 % 
acesulfame (acid form on a dry basis)  
Description  A white, odourless, crystalline powder  
Identification  
Solubility  Sparingly soluble water; slightly soluble in ethanol  
Transmittance  The transmittance of a 1 % solution in water determined in a 1 cm 
cell at 430 nm with a suitable spectrophotometer using water as a reference, is not less than 0,95, equivalent to an absorbance of not 
more than approximately 0,022.
 
Specific rotation  [ α] D 20 + 14,5° to + 16,5° 
Determine at a concentration of 6,2 g in 100 ml formic acid (15N) 
within 30 min of preparation of the solution. Divide the calculated 
specific rotation by 0,646 to correct for the aspartame content of the salt of aspartame-acesulfame
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 257
 
Purity  
Loss on drying  Not more than 0,5 % (105 °C, 4 hours)  
5-Benzyl-3,6-dioxo-2-piperazineacetic 
acid Not more than 0,5 %  
Lead  Not more than 1 mg/kg  
▼M1 
E 964 POLYGLYCITOL SYRUP 
Synonyms  Hydrogenated starch hydrolysate, hydrogenated glucose syrup and 
polyglucitol  
Definition  A mixture consisting mainly of maltitol and sorbitol and lesser 
amounts of hydrogenated oligo- and polysaccharides and maltro ­
triitol. It is manufactured by the catalytic hydrogenation of a 
mixture of starch hydrolysates consisting of glucose, maltose and higher glucose polymers, similar to the catalytic hydrogenation process used for the manufacture of maltitol syrup. The resulting 
syrup is desalted by ion exchange and concentrated to the desired 
level.
 
Einecs  
Chemical name  Sorbitol: D-glucitol  
Maltitol: ( α)-D-Glucopyranosyl-1,4-D-glucitol  
Chemical formula  Sorbitol: C  6 H 14 O 6 
Maltitol: C  12 H 24 O 11 
Molecular weight  Sorbitol: 182,2  
Maltitol: 344,3  
Assay  Content not less than 99 % of total hydrogenated saccharides on the 
anhydrous basis, not less than 50 % higher molecular weight polyols, not more than 50 % of maltitol and not more than 20 % of sorbitol on the anhydrous basis.
 
Description  Colourless and odourless clear viscous liquid  
Identification  
Solubility  Very soluble in water and slightly soluble in ethanol  
Test for maltitol  Passes test  
Test for sorbitol  To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde 
and 1 ml of hydrochloric acid. Mix and shake in a mechanical 
shaker until crystals appear. Filter the crystals and dissolve in 20 ml of boiling water containing 1 g of sodium bicarbonate. Filter the crystals, wash with 5 ml of a water-methanol mixture (1 
in 2) and dry in the air. The crystals of the monobenzylidine 
derivative of sorbitol so obtained melt between 173 and 179 °C.
 
Purity  
Water content  Not more than 31 % (Karl Fischer method)  
Chlorides  Not more than 50 mg/kg  
Sulphates  Not more than 100 mg/kg  
Reducing sugars  Not more than 0,3 %  
Nickel  Not more than 2 mg/kg  
Lead  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 258
 
E 965 (i) MALTITOL 
Synonyms  D-Maltitol; Hydrogenated maltose  
Definition  Maltitol is obtained by hydrogenation of D-maltose. It is mainly 
composed of D-maltitol. It may contain small amounts of sorbitol 
and related polyhydric alcohols.  
Einecs  209-567-0  
Chemical name  ( α)-D-Glucopyranosyl-1,4-D-glucitol  
Chemical formula  C  12 H 24 O 11 
Molecular weight  344,3  
Assay  Content not less than 98 % D-maltitol C  12 H 24 O 11 on the anhydrous 
basis  
Description  White crystalline powder  
Identification  
Solubility  Very soluble in water, slightly soluble in ethanol  
Melting range  148 to 151 °C  
Specific rotation  [ α] D 20 + 105,5° to + 108,5° (5 % w/v solution)  
▼M4 
Purity  
Appearance of the aqueous solution  The solution is clear and colourless  
Water content  Not more than 1 % (Karl Fischer Method)  
Conductivity  Not more than 20 μS/cm (on 20 % dry solids solution) at 
temperature 20 °C  
Reducing sugars  Not more than 0,1 % (expressed as glucose on an anhydrous basis)  
Nickel  Not more than 2 mg/kg (expressed on anhydrous basis)  
Arsenic  Not more than 3 mg/kg (expressed on anhydrous basis)  
Lead  Not more than 1 mg/kg (expressed on anhydrous basis)  
▼B 
E 965 (ii) MALTITOL SYRUP 
Synonyms  Hydrogenated high-maltose-glucose syrup; Hydrogenated glucose 
syrup; Maltitol liquid  
Definition  A mixture consisting of mainly maltitol with sorbitol and hydro ­
genated oligo- and polysaccharides. It is manufactured by the 
catalytic hydrogenation of high maltose-content glucose syrup or 
by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product.
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 99 % of total hydrogenated saccharides on the 
anhydrous basis and not less than 50 % of maltitol on the anhydrous 
basis  
Description  Colourless and odourless, clear viscous liquids or white crystalline 
masses  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 259
 
Identification  
Solubility  Very soluble in water, slightly soluble in ethanol  
HPLC test  Comparison with an appropriate reference standard of Maltitol shows 
that the principle peak in the chromatogram of the test solution is 
similar in retention time to the principal peak in the chromatogram obtained with the reference solution (ISO 10504:1998).
 
▼M4 
Purity  
Appearance of the aqueous solution  The solution is clear and colourless  
Water content  Not more than 31 % (Karl Fischer Method)  
Conductivity  Not more than 10 μS/cm (on the product as such) at temperature 
20 °C  
Reducing sugars  Not more than 0,3 % (expressed as glucose on an anhydrous basis)  
Nickel  Not more than 2 mg/kg  
Lead  Not more than 1 mg/kg  
▼B 
E 966 LACTITOL 
Synonyms  Lactit; Lactositol; Lactobiosit  
Definition  Lactitol is manufactured via catalytic hydrogenation of lactose  
Einecs  209-566-5  
Chemical name  4-O- β-D-Galactopyranosyl-D-glucitol  
Chemical formula  C  12 H 24 O 11 
Molecular weight  344,3  
Assay  Not less than 95 % on the dry weight basis  
Description  Crystalline powder or colourless solution. Crystalline products occur 
in anhydrous, monohydrate and dihydrate forms. Nickel is used as a catalyst.
 
Identification  
Solubility  Very soluble in water  
Specific rotation  [ α] D 20 = + 13° to + 16° calculated on the anhydrous basis (10 % w/v 
aqueous solution)  
Purity  
Water content  Crystalline products; not more than 10,5 % (Karl Fischer method)  
Other polyols  Not more than 2,5 % (on the anhydrous basis)  
Reducing sugars  Not more than 0,2 % (expressed as glucose on dry weight basis)  
Chlorides  Not more than 100 mg/kg (expressed on dry weight basis)  
Sulphates  Not more than 200 mg/kg (expressed on dry weight basis)  
Sulphated ash  Not more than 0,1 % (expressed on dry weight basis)  
Nickel  Not more than 2 mg/kg (expressed on dry weight basis)  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 260
 
E 967 XYLITOL 
Synonyms  Xylitol  
Definition  Xylitol is mainly composed of D-xylitol. The part which is not D- 
xylitol is composed of related substances such as L-arabinitol, 
galactitol, mannitol, sorbitol  
Einecs  201-788-0  
Chemical name  D-xylitol  
Chemical formula  C  5 H 12 O 5 
Molecular weight  152,2  
Assay  Not less than 98,5 % as xylitol on the anhydrous basis  
Description  White, crystalline powder, practically odourless.  
Identification  
Solubility  Very soluble in water, sparingly soluble in ethanol  
Melting range  92 to 96 °C  
pH 5 to 7 (10 % w/v aqueous solution)  
Infrared absorption spectroscopy  Comparison with a reference standard e.g. EP or USP.  
▼M4 
Purity  
Water content  Not more than 1 % (Karl Fischer Method)  
Conductivity  Not more than 20 μS/cm (on 20 % dry solids solution) at 
temperature 20 °C  
Reducing sugars  Not more than 0,2 % (expressed as glucose on dry weight basis)  
Other polyhydric alcohols  Not more than 1 % (expressed on dry weight basis)  
Nickel  Not more than 2 mg/kg (expressed on dry weight basis)  
Arsenic  Not more than 3 mg/kg (expressed on dry weight basis)  
Lead  Not more than 1 mg/kg (expressed on dry weight basis)  
▼B 
E 968 ERYTHRITOL 
Synonyms  Meso-erythritol; Tetrahydroxybutane; Erythrite  
Definition  Obtained by fermentation of carbohydrate source by safe and 
suitable food grade osmophilic yeasts such as  Moniliella pollinis  
or Moniliella megachilensis , followed by purification and drying  
Einecs  205-737-3  
Chemical name  1,2,3,4-Butanetetrol  
Chemical formula  C  4 H 10 O 4 
Molecular weight  122,12  
Assay  Not less than 99 % after drying  
Description  White, odourless, non-hygroscopic, heat-stable crystals with a 
sweetness of approximately 60-80 % that of sucrose.  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 261
 
Identification  
Solubility  Freely soluble in water, slightly soluble in ethanol, insoluble in 
diethyl ether.  
Melting range  119-123 °C  
▼M4 
Purity  
Loss on drying  Not more than 0,2 % (70 °C, 6 hours, in a vacuum desiccator)  
Conductivity  Not more than 20 μS/cm (on 20 % dry solids solution) at 
temperature 20 °C  
Reducing substances  Not more than 0,3 % expressed as D-glucose  
Ribitol and glycerol  Not more than 0,1 %  
Lead  Not more than 0,5 mg/kg  
▼M11  
E 969 ADVANTAME 
Synonyms  
Definition  Advantame (ANS9801) is produced by chemical synthesis in a three- 
step process; production of the principal manufacturing intermediate, 
3-hydroxy-4-methoxycinnamaldehyde (HMCA), followed by hydrogenation to form 3-(3-hydroxy-4-methoxyphenyl) propional ­
dehyde (HMPA). In the final step, the HMPA methanol solution 
(filtrate) is combined with aspartame to give the imine that under 
selective hydrogenation forms advantame. The solution is allowed to crystallise and crude crystals are washed. The product is re-cryst ­
allised and crystals are separated, washed and dried.
 
CAS No.  714229-20-6  
Chemical name  N-[ N-[3-(3-hydroxy-4-methoxyphenyl) propyl]- α-aspartyl]-L-pheny ­
lalanine 1-methyl ester, monohydrate (IUPAC); 
L-phenylalanine, N-[3-(3-hydroxy-4-methoxyphenyl)propyl]-L- 
alpha-aspartyl-, 2-methyl ester, monohydrate (CA)  
Molecular formula  C24H30N2O7 ·H 2 O 
Molecular weight  476,52 g/mol (monohydrate)  
Assay  Not less than 97,0 % and not more than 102,0 % on an anhydrous 
basis  
Description  White to yellow powder  
Identification  
Melting Point  101,5 °C  
Purity  
N-[N-[3-(3-hydroxy-4-methoxyphe ­
nyl)propyl- α-aspartyl]-L-phenylalanine 
(ANS9801-acid)  Not more than 1,0 %  
Total other related substances  Not more than 1,5 %  
Residual Solvents  Isopropyl acetate: Not more than 2 000 mg/kg 
Methyl acetate: Not more than 500 mg/kg 
Methanol: Not more than 500 mg/kg 
2-Propanol: Not more than 500 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 262
 
Water content  Not more than 5,0 % (Karl Fischer method)  
Residue on ignition  Not more than 0,2 %  
Arsenic  Not more than 2 mg/kg  
Lead  Not more than 1 mg/kg  
Palladium  Not more than 5,3 mg/kg  
Platinum  Not more than 1,7 mg/kg  
▼B 
E 999 QUILLAIA EXTRACT 
Synonyms  Soapbark extract; Quillay bark extract; Panama bark extract; Quillai 
extract; Murillo bark extract; China bark extract  
Definition  Quillaia extract is obtained by aqueous extraction of  Quillaia 
saponaria Molina , or other  Quillaia  species, trees of the family  
Rosaceae . It contains a number of triterpenoid saponins consisting 
of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along 
with tannin, calcium oxalate and other minor components
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  Quillaia extract in the powder form is light brown with a pink tinge. 
It is also available as an aqueous solution  
Identification  
pH Between 3,7 and 5,5 (4 % solution)  
Purity  
Water content  Not more than 6,0 % (Karl Fischer method) (powder form only)  
Arsenic  Not more than 2 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
E 1103 INVERTASE 
Synonyms  
Definition  Invertase is produced from  Saccharomyces cerevisiae  
Einecs  232-615-7  
Enzyme Commission No  EC 3.2.1.26  
Systematic name  β-D-Fructofuranoside fructohydrolase  ▼M11  2012R0231 — EN — 11.07.2014 — 008.001 — 263
 
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  
Identification  
Purity  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Cadmium  Not more than 0,5 mg/kg  
Microbiological criteria  
Total bacterial count  Not more than 50 000 colonies per gram  
Salmonella  spp.  Absent in 25 g  
Coliforms  Not more than 30 colonies per gram  
Escherichia coli  Absent in 25 g  
E 1105 LYSOZYME 
Synonyms  Lysozyme hydrochloride; Muramidase  
Definition  Lysozyme is a linear polypeptide obtained from hens' egg whites 
consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic 
acid and N-acetylglucosamine in the outer membranes of bacterial 
species, in particular gram-positive organisms. Is usually obtained as 
the hydrochloride
 
Einecs  232-620-4  
Enzyme Commission No  EC 3.2.1.17  
Chemical name  
Chemical formula  
Molecular weight  About 14 000  
Assay  Content not less than 950 mg/g on the anhydrous basis  
Description  White, odourless powder having a slightly sweet taste  
Identification  
Isoelectric point  10,7  
pH Between 3,0 and 3,6 (2 % aqueous solution)  
Spectrophotometry  Absorption maximum of an aqueous solution (25 mg/100 ml) at 
281 nm, a minimum at 252 nm  
Purity  
Water content  Not more than 6,0 % (Karl Fischer method) (powder form only)  
Residue on ignition  Not more than 1,5 %  
Nitrogen  Not less than 16,8 % and not more than 17,8 %  
Arsenic  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 264
 
Lead  Not more than 5 mg/kg  
Mercury  Not more than 1 mg/kg  
Microbiological criteria  
Total bacterial count  Not more than 5 × 10  4 colonies per gram  
Salmonella  spp.  Absent in 25 g  
Staphylococcus aureus  Absent in 1 g  
Escherichia coli  Absent in 1 g  
E 1200 POLYDEXTROSE 
Synonyms  Modified polydextroses  
Definition  Randomly bonded glucose polymers with some sorbitol end-groups, 
and with citric acid or phosphoric acid residues attached to the 
polymers by mono or diester bonds. They are obtained by melting 
and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid and/or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the 
polymers but other linkages are present. The products contain small 
quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D- glucose) and citric acid and may be neutralised with any food grade base and/or decolourised and deionised for further purification. 
The products may also be partially hydrogenated with Raney nickel 
catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextrose
 
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  Content not less than 90 % of polymer on the ash free and 
anhydrous basis  
Description  White to light tan-coloured solid. Polydextroses dissolve in water to 
give a clear, colourless to straw coloured solution  
Identification  
Test for sugar  Passes test  
Test for reducing sugar  Passes test  
pH Between 2,5 and 7,0 for polydextrose (10 % solution) 
Between 5,0 and 6,0 for polydextrose-N (10 % solution)  
Purity  
Water content  Not more than 4,0 % (Karl Fischer method)  
Sulphated ash  Not more than 0,3 % (polydextrose) 
Not more than 2,0 % (polydextrose N)  
Nickel  Not more than 2 mg/kg for hydrogenated polydextroses  
1,6-Anhydro-D-glucose  Not more than 4,0 % on the ash-free and the dried basis  
Glucose and sorbitol  Not more than 6,0 % combined on the ash-free and the dried basis; 
glucose and sorbitol are determined separately  
Molecular weight limit  Negative test for polymers of molecular weight greater than 22 000  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 265
 
5-Hydroxy-methylfurfural  Not more than 0,1 % (polydextrose) 
Not more than 0,05 % (polydextrose-N)  
Lead  Not more than 0,5 mg/kg  
E 1201 POLYVINYLPYRROLIDONE 
Synonyms  Povidone; PVP; Soluble polyvinylpyrrolidone  
Definition  
Einecs  
Chemical name  Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]  
Chemical formula  (C  6 H 9 NO)  n 
Average molecular weight  Not less than 25 000  
Assay  Content not less than 11,5 % and not more than 12,8 % of nitrogen 
(N) on the anhydrous basis  
Description  White or nearly white powder  
Identification  
Solubility  Soluble in water and in ethanol. Insoluble in ether  
pH Between 3,0 and 7,0 (5 % solution)  
Purity  
Water content  Not more than 5 % (Karl Fischer)  
Total ash  Not more than 0,1 %  
Aldehyde  Not more than 500 mg/kg (as acetaldehyde)  
Free-N-vinylpyrrolidone  Not more than 10 mg/kg  
Hydrazine  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg  
E 1202 POLYVINYLPOLYPYRROLIDONE 
Synonyms  Crospovidone; Cross-linked polyvidone; Insoluble polyvinylpyr ­
rolidone  
Definition  Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethy ­
lene], cross linked in a random fashion. It is produced by the poly ­
merisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to 
analytical determination
 
Einecs  
Chemical name  Polyvinylpyrrolidone; poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]  
Chemical formula  (C  6 H 9 NO)  n 
Molecular weight  
Assay  Content not less than 11 % and not more than 12,8 % nitrogen (N) 
on the anhydrous basis  
Description  A white hygroscopic powder with a faint, non-objectionable odour  
Identification  
Solubility  Insoluble in water, ethanol and ether  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 266
 
pH Between 5,0 and 8,0 (1 % suspension in water)  
Purity  
Water content  Not more than 6 % (Karl Fischer)  
Sulphated ash  Not more than 0,4 %  
Water-soluble matter  Not more than 1 %  
Free-N-vinylpyrrolidone  Not more than 10 mg/kg  
Free-N,N'-divinyl-imidazolidone  Not more than 2 mg/kg  
Lead  Not more than 2 mg/kg  
E 1203 POLYVINYL ALCOHOL 
Synonyms  Vinyl alcohol polymer, PVOH  
Definition  Polyvinyl alcohol is a synthetic resin prepared by the polymerisation 
of vinyl acetate, followed by partial hydrolysis of the ester in the 
presence of an alkaline catalyst. The physical characteristics of the 
product depend on the degree of polymerisation and the degree of hydrolysis.
 
Chemical name  Ethenol homopolymer  
Chemical formula  (C  2 H 3 OR)  n where R = H or COCH  3 
Description  Odourless, tasteless, translucent, white or cream-coloured granular 
powder  
Identification  
Solubility  Soluble in water; sparingly soluble in ethanol  
Precipitation reaction  Dissolve 0,25 g of the sample in 5 ml of water with warming and let 
the solution cool to room temperature. The addition of 10 ml of ethanol to this solution leads to a white, turbid or flocculent precipi ­
tate.
 
Colour reaction  Dissolve 0,01 g of the sample in 100 ml of water with warming and 
let the solution cool to room temperature. A blue colour is produced 
when adding (to 5 ml solution) one drop of iodine test solution (TS) 
and a few drops of boric acid solution 
Dissolve 0,5 g of the sample in 10 ml of water with warming and let 
the solution cool to room temperature. A dark red to blue colour is 
produced after adding one drop of iodine TS to 5 ml of solution.  
Viscosity  4,8 to 5,8 mPa.s (4 % solution at 20 °C) corresponding to an 
average molecular weight of 26 000-30 000 Da  
Purity  
Water insoluble matter  Not more than 0,1 %  
Ester value  Between 125 and 153 mg KOH/g  
Degree of hydrolysis  86,5 to 89,0%  
Acid value  Not more than 3,0  
Solvent residues  Not more than 1,0 % Methanol, 1,0 % Methyl acetate  
pH 5,0 to 6,5 (4 % solution)  
Loss on drying  Not more than 5,0 % (105 °C, 3 hours)  
Residue in ignition  Not more than 1,0 %  
Lead  Not more than 2 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 267
 
E 1204 PULLULAN 
Synonyms  
Definition  Linear, neutral glucan consisting mainly of maltotriose units 
connected by -1,6 glycosidic bonds. It is produced by fermentation 
from a food-grade hydrolysed starch using a non-toxin-producing strain of  Aureobasidium pullulans . After completion of the fermen ­
tation, the fungal cells are removed by microfiltration, the filtrate is 
heat-sterilised and pigments and other impurities are removed by 
adsorption and ion exchange chromatography
 
Einecs  232-945-1  
Chemical name  
Chemical formula  (C  6 H 10 O 5 ) n 
Molecular weight  
Assay  Not less than 90 % of glucan on the dried basis  
Description  White to off-white odourless powder  
Identification  
Solubility  Soluble in water, practically insoluble in ethanol  
pH 5,0 to 7,0 (10 % solution)  
Precipitation with polyethylene glycol 
600 Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous 
solution of pullulan. A white precipitate is formed  
Depolymerisation with pullulanase  Prepare two test tubes each with 10 ml of a 10 % pullulan solution. 
Add 0,1 ml pullulanase solution having activity 10 units/g to one 
test tube, and 0,1 ml water to the other. After incubation at about 
25 °C for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution
 
Viscosity  100 to 180 mm  2 /s (10 % w/w aqueous solution at 30 °C)  
Purity  
Loss on drying  Not more than 6 % (90 °C, pressure not more than 50 mm Hg, 6 
hours)  
Mono-, di- and oligosaccharides  Not more than 10 % expressed as glucose  
Lead  Not more than 1 mg/kg  
Microbiological criteria  
Yeast and moulds  Not more than 100 colonies per gram  
Coliforms  Absent in 25 g  
Salmonella  spp.  Absent in 25 g  
E 1205 BASIC METHACRYLATE COPOLYMER 
Synonyms  Basic butylated methacrylate copolymer; amino methacrylate 
copolymer; aminoalkyl methacrylate copolymer E; butyl metha ­
crylate, dimethylaminoethyl methacrylate, methyl methacrylate 
polymer; butyl methacrylate, methyl methacrylate, dimethylami ­
noethyl methacrylate polymer  
Definition  Basic methacrylate copolymer is manufactured by thermic controlled 
polymerisation of the monomers methyl methacrylate, butyl metha ­
crylate and dimethylaminoethyl methacrylate, dissolved in propan-2- 
ol) by using a free radical donor initiator system. An alkyl mercaptane is used as chain modifying agent. The solid polymer is milled (first milling step) and extruded and granulated under vacuum 
to remove residual volatile components. The granules resulting are 
commercialised as such or undergo a second milling step (microni ­
sation).
 ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 268
 
Chemical name  Poly(butyl methacrylate- co-(2-dimethylaminoethyl)methacrylate- co- 
methyl methacrylate) 1:2:1  
Chemical formula  Poly[(CH  2 :C(CH  3 )CO  2 (CH  2 ) 2 N(CH  3 ) 2 )-co-(CH  2 :C(CH  3 )CO  2 CH 3 )- 
co-(CH  2 :C(CH  3 )CO  2 (CH  2 ) 3 CH 3 )] 
Weight average molecular weight 
estimated by gel permeation chroma ­
tography  Approximately 47 000 g/mol  
Particle size of powder (when used forms 
a film)  < 50 μm more than 50 % 
< 0,1 μm 5,1-5,5 %  
Assay  
(according to Ph. Eur. 2.2.20 ‘potentio ­
metric titration’)  20,8-25,5 % dimethylaminoethyl (DMAE) groups on dry substance  
Description  Granules are colourless to yellow tinged, the powder is white  
Identification  
Infrared absorption spectroscopy  To be identified  
Viscosity of a 12,5 % solution in 60:40 
(w/w/) propan-2-ol to acetone  3-6 mPa.s  
Refractive index  [n]  D 20 1,380-1,385  
Solubility  1 g dissolves in 7 g Methanol, Ethanol, propan-2-ol, dichlorome ­
thane, aqueous Hydrochloric acid 1N. 
Not soluble in petroleum ether.  
▼M6 
Purity  
Loss of drying  Not more than 2,0 % (105 °C, 3 h)  
Alkali value  162-198 mg KOH/g of dried substance  
Sulphated ash  Not more than 0,1 %  
Residual monomers  Butylmethacrylate < 1 000 mg/kg 
Methyl methacrylate < 1 000 mg/kg 
Dimethylaminoethyl methacrylate < 1 000 mg/kg  
Solvent residues  propan-2-ol < 0,5 % 
Butanol < 0,5 % 
Methanol < 0,1 %  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 3 mg/kg  
Mercury  Not more than 0,1 mg/kg  
Cadmium  Not more than 1 mg/kg  
E 1206 NEUTRAL METHACRYLATE COPOLYMER 
Synonyms  Ethyl acrylate methyl methacrylate polymer; Ethyl acrylate, methyl 
methacrylate polymer; Ethyl acrylate, polymer with methyl metha ­
crylate; Methyl methacrylate, ethyl acrylate polymer; Methyl metha ­
crylate, polymer with ethyl acrylate  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 269
 
Definition  Neutral methacrylate copolymer is a fully polymerised copolymer of 
methyl methacrylate and ethyl acrylate. It is produced using a process of emulsion polymerisation. It is manufactured by redox initiated polymerisation of the monomers ethyl acrylate, methyl 
methacrylate by using a free radical donor redox initiator system 
stabilised with polyethylene glycol monostearyl ether and vinylic acid/sodium hydroxide. Residual monomers are removed by means of water vapour distillation.
 
CAS No  9010-88-2  
Chemical name  Poly(ethylacrylate-co-methyl methacrylate) 2:1  
Chemical formula  Poly[(CH  2 :CHCO  2 CH 2 CH 3 )-co-(CH  2 :C(CH  3 )CO  2 CH 3 )] 
Weight average molecular weight  Approximately 600 000 g/mol  
Assay/Residue on evaporation  28,5–31,5 % 
1 g dispersion is dried in an oven for 3 hours at 110 °C.  
Description  Milky-white dispersion (the commercial form is a 30 % dispersion of 
the dry substance in water) of low viscosity with a faint char ­
acteristic odour.  
Identification  
Infrared absorption spectroscopy  Characteristic of the compound  
Viscosity  Max. 50 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry)  
pH-value  5,5–8,6  
Relative density (at 20 °C)  1,037–1,047  
Solubility  The dispersion is miscible with water in any proportion. The 
polymer and the dispersion are freely soluble in acetone, ethanol 
and isopropyl alcohol. Not soluble when mixed with 1 N sodium 
hydroxide in a ratio of 1:2.  
Purity  
Sulphated ash  Not more than 0,4 % in the dispersion  
Residual monomers  Total of monomers (sum of methyl methacrylate and ethyl acrylate): 
not more than 100 mg/kg in the dispersion  
Residual emulsifier  Polyethylene glycol monostearyl ether (macrogol stearyl ether 20) 
not more than 0,7 % in the dispersion  
Solvent residues  Ethanol not more than 0,5 % in the dispersion 
Methanol not more than 0,1 % in the dispersion  
Arsenic  Not more than 0,3 mg/kg in the dispersion  
Lead  Not more than 0,9 mg/kg in the dispersion  
Mercury  Not more than 0,03 mg/kg in the dispersion  
Cadmium  Not more than 0,3 mg/kg in the dispersion  
E 1207 ANIONIC METHACRYLATE COPOLYMER 
Synonyms  Methyl acrylate, methyl methacrylate, methacrylic acid polymer; 
Methacrylic acid, polymer with methyl acrylate and methyl metha ­
crylate  ▼M6 2012R0231 — EN — 11.07.2014 — 008.001 — 270
 
Definition  Anionic methacrylate copolymer is a fully polymerised copolymer of 
methacrylic acid, methyl methacrylate and methyl acrylate. It is 
manufactured in aqueous medium by emulsion polymerisation of 
methyl methacrylate, methyl acrylate and methacrylic acid using a free radical initiator stabilised with sodium lauryl sulphate and poly ­
oxyethylene sorbitan monooleate (polysorbate 80). Residual 
monomers are removed by means of water vapour distillation.
 
CAS No  26936-24-3  
Chemical name  Poly (methyl acrylate-co-methylmethacrylate-co-methacrylic acid) 
7:3:1  
Chemical formula  Poly[(CH  2 :CHCO  2 CH 3 )-co-(CH  2 :C(CH  3 )CO  2 CH 3 )-co- 
(CH  2 :C(CH  3 )COOH)]  
Weight average molecular weight  Approximately 280 000 g/mol  
Assay/Residue on evaporation  28,5–31,5 % 
1 g of the dispersion is dried in an oven for 5 hours at 110 °C. 
9,2–12,3 % methacrylic acid units on dry substance.  
Description  Milky-white dispersion (the commercial form is a 30 % dispersion of 
the dry substance in water) of low viscosity with a faint char ­
acteristic odour.  
Identification  
Infrared absorption spectroscopy  Characteristic of the compound  
Viscosity  Max. 20 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry)  
pH-value  2,0–3,5  
Relative density (at 20 °C)  1,058–1,068  
Solubility  The dispersion is miscible with water in any proportion. The 
polymer and the dispersion are freely soluble in acetone, ethanol and isopropyl alcohol. Soluble when mixed with 1 N sodium hydroxide in a ratio of 1:2. Soluble above pH 7,0.
 
Purity  
Acid value  60–80 mg KOH/g of dried substance  
Sulphated ash  Not more than 0,2 % in the dispersion  
Residual monomers  Total of monomers (sum of methacrylic acid, methyl methacrylate 
and methyl acrylate): not more than 100 mg/kg in the dispersion  
Residual emulsifiers  Sodium lauryl sulphate not more than 0,3 % on the dry substance 
Polysorbate 80 not more than 1,2 % on the dry substance  
Solvent residues  Methanol not more than 0,1 % in the dispersion  
Arsenic  Not more than 0,3 mg/kg in the dispersion  
Lead  Not more than 0,9 mg/kg in the dispersion  
Mercury  Not more than 0,03 mg/kg in the dispersion  
Cadmium  Not more than 0,3 mg/kg in the dispersion  ▼M6 2012R0231 — EN — 11.07.2014 — 008.001 — 271
 
E 1208 POLYVINYLPYRROLIDONE-VINYL ACETATE COPOLYMER 
Synonyms  Copolyvidon; copovidone; 1-vinyl-2-pyrrolidone-vinyl acetate 
copolymer; 2-pyrrolidinone, 1-ethenyl-, polymer with ethenyl acetate  
Definition  It is produced by free radical copolymerisation of N-vinyl-2- 
pyrrolidone and vinyl acetate in solution in propan-2-ol, in the 
presence of initiators.  
Einecs  
Chemical name  Acetic acid, ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone  
Chemical formula  (C  6 H 9 NO)  n .(C 4 H 6 O 2 ) m 
Average Viscosity Molecular Weight  Between 26 000 and 46 000 g/mol.  
Assay  Nitrogen content 7,0-8,0 %  
Description  The physical state is described as a white to yellowish-white powder 
or flakes with an average particle size of 50-130 μm. 
Identification  
Solubility  Freely soluble in water, ethanol, ethylene chloride and ether.  
Infrared absorption spectroscopy  To be identified  
European Colour Test (BY Colour)  Minimum BY5  
K-value (  1 ) (1 % solids in aqueous 
solution)  25,2-30,8  
pH value  3,0-7,0 (10 % aqueous solution)  
Purity  
Vinylacetate component in copolymer  Not more than 42,0 %  
Free vinyl acetate  Not more than 5 mg/kg  
Total ash  Not more than 0,1 %  
Aldehyde  Not more than 2 000 mg/kg (as acetaldehyde)  
Free-N-vinylpyrrolidone  Not more than 5 mg/kg  
Hydrazine  Not more than 0,8 mg/kg  
Peroxide content  Not more than 400 mg/kg  
Propan-2-ol  Not more than 150 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
_____________ 
( 1 ) K-value: dimensionless index, calculated from kinematic viscosity measurements of dilute solutions, used to indicate the like ly 
degree of polymerisation or molecular size of a polymer.  ▼M9 2012R0231 — EN — 11.07.2014 — 008.001 — 272
 
E 1209 POLYVINYL ALCOHOL-POLYETHYLENE GLYCOL- GRAFT - 
COPOLYMER 
Synonyms  Macrogol poly(vinyl alcohol) grafted co-polymer; poly(ethan-1,2- 
diol-graft-ethanol); ethenol, polymer with oxirane, graft; oxirane, 
polymer with ethanol, graft; ethylene oxide-vinyl alcohol graft co- polymer
 
Definition  Polyvinyl alcohol-polyethylene glycol-graft-co-polymer is a synthetic 
co-polymer that consists of approximately 75 % PVA units and 25 % PEG units.
 
CAS number  96734-39-3  
Chemical name  Polyvinyl alcohol-polyethylene glycol- graft -co-polymer  
Chemical formula  
Weight Average Molecular Weight  40 000 to 50 000 g/mol  
Description  White to faintly yellow powder  
Identification  
Solubility  Freely soluble in water and dilute acids and dilute solutions of alkali 
hydroxides; practically insoluble in ethanol, acetic acid, acetone, and chloroform
 
IR Spectrum  Must comply  
pH value  5,0-8,0  
Purity  
Ester Value  10 to 75 mg/g KOH  
Dynamic viscosity  50 to 250 mPa ·s 
Loss on drying  Not more than 5 %  
Sulphated Ash  Not more than 2 %  
Vinyl Acetate  Not more than 20 mg/kg  
Acetic acid/Total Acetate  Not more than 1,5 %  
Ethylene glycol  Not more than 50 mg/kg  
Diethylene glycol  Not more than 50 mg/kg  
1,4-Dioxane  Not more than 10 mg/kg  
Ethylene oxide  Not more than 0,2 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 1 mg/kg  
▼B 
E 1404 OXIDISED STARCH 
Synonyms  
Definition  Oxidised starch is starch treated with sodium hypochlorite  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  ▼M13  2012R0231 — EN — 11.07.2014 — 008.001 — 273
 
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  
Purity  
Loss on drying  Not more than 15,0 % for cereal starch 
Not more than 21,0 % for potato starch 
Not more than 18,0 % for other starches  
Carboxyl groups  Not more than 1,1 % (on an anhydrous basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for other modified starches, unless 
otherwise specified (on an anhydrous basis)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  
E 1410 MONOSTARCH PHOSPHATE 
Synonyms  
Definition  Monostarch phosphate is starch esterified with ortho-phosphoric 
acid, or sodium or potassium ortho-phosphate or sodium tripolyphos ­
phate  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  
Purity  
Loss on drying  Not more than 15,0 % for cereal starch 
Not more than 21,0 % for potato starch 
Not more than 18,0 % for other starches  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 274
 
Residual phosphate  Not more than 0,5 % (as P) for wheat or potato starch (on an 
anhydrous basis) 
Not more than 0,4 % (as P) for other starches (on an anhydrous 
basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for other modified starches, unless 
otherwise specified (on an anhydrous basis)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  
E 1412 DISTARCH PHOSPHATE 
Synonyms  
Definition  Distarch phosphate is starch cross-linked with sodium trimeta ­
phosphate or phosphorus oxychloride  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  
Purity  
Loss on drying  Not more than 15,0 % for cereal starch 
Not more than 21,0 % for potato starch 
Not more than 18,0 % for other starches  
Residual phosphate  Not more than 0,5 % (as P) for wheat or potato starch (on an 
anhydrous basis) 
Not more than 0,4 % (as P) for other starches (on an anhydrous 
basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for other modified starches, unless 
otherwise specified (on an anhydrous basis)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 275
 
E 1413 PHOSPHATED DISTARCH PHOSPHATE 
Synonyms  
Definition  Phosphated distarch phosphate is starch having undergone a 
combination of treatments as described for monostarch phosphate 
and for distarch phosphate  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  
Purity  
Loss on drying  Not more than 15,0 % for cereal starch 
Not more than 21,0 % for potato starch 
Not more than 18,0 % for other starches  
Residual phosphate  Not more than 0,5 % (as P) for wheat or potato starch (on an 
anhydrous basis) 
Not more than 0,4 % (as P) for other starches (on an anhydrous 
basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for other modified starches, unless 
otherwise specified (on an anhydrous basis)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  
E 1414 ACETYLATED DISTARCH PHOSPHATE 
Synonyms  
Definition  Acetylated distarch phosphate is starch cross-linked with sodium 
trimetaphosphate or phosphorus oxychloride and esterified by 
acetic anhydride or vinyl acetate  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 276
 
Purity  
Loss on drying  Not more than 15,0 % for cereal starch 
Not more than 21,0 % for potato starch 
Not more than 18,0 % for other starches  
Acetyl groups  Not more than 2,5 % (on an anhydrous basis)  
Residual phosphate  Not more than 0,14 % (as P) for wheat or potato starch (on an 
anhydrous basis) 
Not more than 0,04 % (as P) for other starches (on an anhydrous 
basis)  
Vinyl acetate  Not more than 0,1 mg/kg (on an anhydrous basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for other modified starches, unless 
otherwise specified (on an anhydrous basis)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  
E 1420 ACETYLATED STARCH 
Synonyms  Starch acetate  
Definition  Acetylated starch is starch esterified with acetic anhydride or vinyl 
acetate  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  
Purity  
Loss on drying  Not more than 15,0 % for cereal starch 
Not more than 21,0 % for potato starch 
Not more than 18,0 % for other starches  
Acetyl groups  Not more than 2,5 % (on an anhydrous basis)  
Vinyl acetate  Not more than 0,1 mg/kg (on an anhydrous basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for other modified starches, unless 
otherwise specified (on an anhydrous basis)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 277
 
E 1422 ACETYLATED DISTARCH ADIPATE 
Synonyms  
Definition  Acetylated distarch adipate is starch cross-linked with adipic 
anhydride and esterified with acetic anhydride  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  
Purity  
Loss on drying  Not more than 15,0 % for cereal starch 
Not more than 21,0 % for potato starch 
Not more than 18,0 % for other starches  
Acetyl groups  Not more than 2,5 % (on an anhydrous basis)  
Adipate groups  Not more than 0,135 % (on an anhydrous basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for other modified starches, unless 
otherwise specified (on an anhydrous basis)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  
E 1440 HYDROXYPROPYL STARCH 
Synonyms  
Definition  Hydroxypropyl starch is starch etherified with propylene oxide  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 278
 
Purity  
Loss on drying  Not more than 15,0 % for cereal starch 
Not more than 21,0 % for potato starch 
Not more than 18,0 % for other starches  
Hydroxypropyl groups  Not more than 7,0 % (on an anhydrous basis)  
Propylene chlorohydrin  Not more than 1 mg/kg (on an anhydrous basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for other modified starches, unless 
otherwise specified (on an anhydrous basis)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  
E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE 
Synonyms  
Definition  Hydroxypropyl distarch phosphate is starch cross-linked with sodium 
trimetaphosphate or phosphorus oxychloride and etherified with 
propylene oxide  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  
Purity  
Loss on drying  Not more than 15,0 % for cereal starch 
Not more than 21,0 % for potato starch 
Not more than 18,0 % for other starches  
Hydroxypropyl groups  Not more than 7,0 % (on an anhydrous basis)  
Residual phosphate  Not more than 0,14 % (as P) for wheat or potato starch (on an 
anhydrous basis) 
Not more than 0,04 % (as P) for other starches (on an anhydrous 
basis)  
Propylene chlorohydrin  Not more than 1 mg/kg (on an anhydrous basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for other modified starches, unless 
otherwise specified (on an anhydrous basis)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 279
 
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  
E 1450 STARCH SODIUM OCTENYL SUCCINATE 
Synonyms  SSOS  
Definition  Starch sodium octenyl succinate is starch esterified with octe ­
nylsuccinic anhydride  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  
Purity  
Loss on drying  Not more than 15,0 % for cereal starch 
Not more than 21,0 % for potato starch 
Not more than 18,0 % for other starches  
Octenylsuccinyl groups  Not more than 3 % (on an anhydrous basis)  
Octenylsuccinic acid residue  Not more than 0,3 % (on an anhydrous basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for other modified starches, unless 
otherwise specified (on an anhydrous basis)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  
E 1451 ACETYLATED OXIDISED STARCH 
Synonyms  
Definition  Acetylated oxidised starch is starch treated with sodium hypochlorite 
followed by esterification with acetic anhydride  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 280
 
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  
Purity  
Loss on drying  Not more than 15,0 % for cereal starch 
Not more than 21,0 % for potato starch 
Not more than 18,0 % for other starches  
Carboxyl groups  Not more than 1,3 % (on an anhydrous basis)  
Acetyl groups  Not more than 2,5 % (on an anhydrous basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for other modified starches, unless 
otherwise specified (on an anhydrous basis)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  
E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE 
Synonyms  
Definition  Starch aluminium octenyl succinate is starch esterified with octe ­
nylsuccinic anhydride and treated with aluminium sulphate  
Einecs  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powder or granules or (if pregelatinised) 
flakes, amorphous powder or coarse particles  
Identification  
Microscopic observation  Passes test (if not pregelatinised)  
Iodine staining  Passes test (dark blue to light red colour)  
Purity  
Loss on drying  Not more than 21,0 %  
Octenylsuccinyl groups  Not more than 3 % (on an anhydrous basis)  
Octenylsuccinic acid residue  Not more than 0,3 % (on an anhydrous basis)  
Sulphur dioxide  Not more than 50 mg/kg for modified cereal starches (on an 
anhydrous basis) 
Not more than 10 mg/kg for the other modified starches, unless 
otherwise specified (on an anhydrous basis)  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg (on an anhydrous basis)  
Mercury  Not more than 0,1 mg/kg  
Aluminium  Not more than 0,3 % (on an anhydrous basis)  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 281
 
E 1505 TRIETHYL CITRATE 
Synonyms  Ethyl citrate  
Definition  
Einecs  201-070-7  
Chemical name  Triethyl-2-hydroxypropan-1,2,3-tricarboxylate  
Chemical formula  C  12 H 20 O 7 
Molecular weight  276,29  
Assay  Content not less than 99,0 %  
Description  Odourless, practically colourless, oily liquid  
Identification  
Specific gravity (25° C/25 °C)  1,135-1,139  
Refractive index  [n]  D 20 : 1,439-1,441  
Purity  
Water content  Not more than 0,25 % (Karl Fischer method)  
Acidity  Not more than 0,02 % (as citric acid)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
E 1517 GLYCERYL DIACETATE 
Synonyms  Diacetin  
Definition  Glyceryl diacetate consist predominantly of a mixture of the 1, 2- 
and 1,3-diacetates of glycerol, with minor amounts of the mono- and tri-esters
 
Einecs  
Chemical name  Glyceryl diacetate; 1, 2, 3-propanetriol diacetate  
Chemical formula  C  7 H 12 O 5 
Molecular weight  176,17  
Assay  Not less than 94,0 %  
Description  Clear, colourless, hygroscopic, somewhat oily liquid with a slight, 
fatty odour  
Identification  
Solubility  Soluble in water. Miscible with ethanol  
Test for glycerol  Passes test  
Test for acetate  Passes test  
Specific gravity (20° C/20 °C)  1,175-1,195  
Boiling range  Between 259 and 261 °C  
Purity  
Total ash  Not more than 0,02 %  
Acidity  Not more than 0,4 % (as acetic acid)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 282
 
E 1518 GLYCERYL TRIACETATE 
Synonyms  Triacetin  
Definition  
Einecs  203-051-9  
Chemical name  Glyceryl triacetate  
Chemical formula  C  9 H 14 O 6 
Molecular weight  218,21  
Assay  Content not less than 98,0 %  
Description  Colourless, somewhat oily liquid having a slightly fatty odour  
Identification  
Test for acetate  Passes test  
Test for glycerol  Passes test  
Refractive index  [n]  D 25 between 1,429 and 1,431  
Specific gravity (25 °C/25 °C)  Between 1,154 and 1,158  
Boiling range  Between 258 and 270 °C  
Purity  
Water content  Not more than 0,2 % (Karl Fischer method)  
Sulphated ash  Not more than 0,02 % (as citric acid)  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
E 1519 BENZYL ALCOHOL 
Synonyms  Phenylcarbinol; Phenylmethyl alcohol; Benzenemethanol; Alpha- 
hydroxytoluene  
Definition  
Einecs  
Chemical name  Benzyl alcohol; Phenylmethanol  
Chemical formula  C  7 H 8 O 
Molecular weight  108,14  
Assay  Not less than 98,0 %  
Description  Colourless, clear liquid with a faint, aromatic odour  
Identification  
Solubility  Soluble in water, ethanol and ether  
Refractive index  [n]  D 20 1,538-1,541  
Specific gravity (25° C/25 °C)  1,042-1,047  
Test for peroxides  Passes test  
Distillation range  Not less than 95 % v/v distils between 202 and 208 °C  
Purity  
Acid value  Not more than 0,5  
Aldehydes  Not more than 0,2 % v/v (as benzaldehyde)  
Lead  Not more than 2 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 283
 
E 1520 PROPANE-1,2-DIOL 
Synonyms  Propylene glycol  
Definition  
Einecs  200-338-0  
Chemical name  1,2-dihydroxypropane  
Chemical formula  C  3 H 8 O 2 
Molecular weight  76,10  
Assay  Content not less than 99,5 % on the anhydrous basis  
Description  Clear, colourless, hygroscopic, viscous liquid  
Identification  
Solubility  Soluble in water, ethanol and acetone  
Specific gravity (20° C/20 °C)  1,035-1,040  
Refractive index  [n]  D 20 : 1,431-1,433  
Purity  
Distillation test  99,5% of the product distils between 185-189 °C. The remaining 
0,5% consists mainly of dimers and traces of trimers from propylene glycol.
 
Sulphated ash  Not more than 0,07 %  
Water content  Not more than 1,0 % (Karl Fischer method)  
Lead  Not more than 2 mg/kg  
E 1521 POLYETHYLENE GLYCOL 
Synonyms  PEG; Macrogol; Polyethylene oxide  
Definition  Addition polymers of ethylene oxide and water usually designated 
by a number roughly corresponding to the molecular weight.  
Chemical name  alpha-Hydro-omega-hydroxypoly (oxy-1,2-ethanediol)  
Chemical formula  (C  2 H 4 O) n H 2 O (n = number of ethylene oxide units corresponding to 
a molecular weight of 6 000, about 140)  
Average molecular weight  380 to 9 000 Da  
Assay  PEG 400: Not less than 95 % and not more than 105 % 
PEG 3000: Not less than 90 % and not more than 110 % 
PEG 3350: Not less than 90 % and not more than 110 % 
PEG 4000: Not less than 90 % and not more than 110 % 
PEG 6000:Not less than 90 % and not more than 110 % 
PEG 8000: Not less than 87,5 % and not more than 112,5 %  
Description  PEG 400 is a clear, viscous, colourless or almost colourless hygro ­
scopic liquid 
PEG 3000, PEG 3350, PEG 4000, PEG 6000 and PEG 8000 are 
white or almost white solids with a waxy or paraffin-like appearance  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 284
 
Identification  
Melting range  PEG 400: 4-8 °C 
PEG 3000: 50-56 °C 
PEG 3350: 53-57 °C 
PEG 4000: 53-59 °C 
PEG 6000:55-61 °C 
PEG 8000: 55-62 °C  
Viscosity  PEG 400: 105 to 130 mPa.s at 20 °C 
PEG 3000: 75 to 100 mPa.s at 20 °C 
PEG 3350: 83 to 120 mPa.s at 20 °C 
PEG 4000: 110 to 170 mPa.s at 20 °C 
PEG 6000: 200 to 270 mPa.s at 20 °C 
PEG 8000: 260 to 510 mPa.s at 20 °C 
For polyethylene glycols having a average molecular weight greater 
than 400, the viscosity is determined on a 50 per cent m/m solution of the candidate substance in water
 
Solubility  PEG 400 is miscible with water, very soluble in acetone, in alcohol 
and in methylene chloride, practically insoluble in fatty oils and in 
mineral oils 
PEG 3000 and PEG 3350: very soluble in water and in methylene 
chloride, very slightly soluble in alcohol, practically insoluble in 
fatty oils and in mineral oils 
PEG 4000, PEG 6000 and PEG 8000: very soluble in water and in 
methylene chloride, practically insoluble in alcohol and in fatty oils 
and in mineral oils.  
Purity  
Hydroxyl value  PEG 400: 264-300 
PEG 3000: 34-42 
PEG 3350: 30-38 
PEG 4000: 25-32 
PEG 6000: 16-22 
PEG 8000: 12-16  
Sulphated ash  Not more than 0,2 %  
1,4-Dioxane  Not more than 10 mg/kg  
Ethylene oxide  Not more than 0,2 mg/kg  
Ethylene glycol and diethylene glycol  Total not more than 0,25 % °w/w individually or in combination  
Lead  Not more than 1 mg/kg  ▼B 2012R0231 — EN — 11.07.2014 — 008.001 — 285