ANNEX  
 Note: Ethylene oxide may not be used fo r sterilising purposes in food additives
 
 Aluminium lakes for use in colour s 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 ma terial made by reacting 
aluminium sulphate or chloride with sodium or calcium 
carbonate or bicarbonate or ammonia. Following lake 
formation, the product is filtered, washed with water 
and dried. Unreacted alumina may also be present in the 
finished product. 
HCI insoluble matter 
ΝaΟΗ insoluble matter Not more than 0,5 % 
Νot more than 0,5 %, for Ε 127 erythrosine only 
Not more than 0,2 % (under neutral conditions) Ether extractable matter 
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 solv ent extraction of turmeric 
i.e. the ground rhizomes of strains of Curcuma longa  L. 
In order to obtain a concen trated 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 dismethoxy 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: ethylacetat e, acetone, carbon dioxide, 
dichloromethane, n-butanol, methanol, ethanol, hexane, 
isopropanol. 
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 21H20O6 
II C 20H18O5 
III C 19H16O4 
Molecular weight I. 368,39 II. 338,39 III. 308,39 
Content not less than 90 % total colouring matters Assay 
E1cm1 %  1607 at ca 426 nm in ethanol 
Description  Orange-yellow crystalline powder 
Identification   
Spectrometry Maximum in ethanol at ca 426 nm 
Melting Range 179 °C—182 °C 
Purity   
Ethylacetate 
Acetone 
n-butanol 
Methanol 
Ethanol 
Hexane 
Isopropanol Not more than 50 mg/kg, singly or in 
combination Solvent residues 
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-
tetrahydroxypentyl)benzo(g )pteridine-2,4(3H,10H)-
dione; 7,8-dimethyl-10-(1 ′-D-ribityl)isoalloxazine 
Chemical formula C 17H20N4O6 
Molecular weight 376,37 
Content not less than 98 % on the anhydrous basis Assay 
E1 cm1 % 328 at ca 444 nm in aqueous solution 
Description  Yellow to orange-yellow crysta lline powder, with slight 
odour 
Identification   
The ratio A 375/A267 is 
between 0,31 and 0,33 
The ratio A 444/A267 is 
between 0,36 and 0,39 in aqueous solution Spectrometry 
Maximum in water at ca 375 nm 
Specific rotation [ α]D20 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) 
Sulphated ash Not more than 0,1 % 
Primary aromatic amines Not more th an 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 amo unts 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 
For the dihydrate form: C 17H20N4NaO 9P · 2H 2O Chemical formula 
For the anhydrous form: C 17H20N4NaO 9P 
Molecular weight 514,36 
Content not less than 95 % total colouring matters 
calculated as C 17H20N4NaO 9P.2H 2O Assay 
E1 cm1 % 250 at ca 375 nm in aqueous solution 
Description  Yellow to orange crystalline hygroscopic powder, with 
slight odour  
Identification  
The ratio A 375/A267 is 
between 0,30 and 0,34 
The ratio A 444/A267 is 
between 0,35 and 0,40 in aqueous solution Spectrometry 
Maximum in water at ca 375 nm 
Specific rotation [ α]D20 between + 38° and + 42° in a 5 molar HCI 
solution 
Purity  
Loss on drying Not more than 8 % (100 °C, 5 hours in vacuum over 
P2O5) 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) 
Riboflavin (free): Not more than 6 % Subsidiary colouring matters 
Riboflavine diphosphate: Not more than 6 % 
Primary aromatic amines Not more th an 70 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 102 TARTRAZINE 
Synonyms  CI Food Yellow 4 
Definition  Tartrazine is prepared fr om 4-amino-benzenesulphonic 
acid, which is diazotized us ing hydrochloric acid and 
sodium nitrite. The diazo compound is then coupled with 4,5-dihydro-5-oxo-1-(4sulphophenyl)-1H-pyrazole-3-carboxylic acid or w ith the methyl ester, the 
ethyl ester, or a salt of  this carboxylic acid. The 
resulting dye is purified and is olated as the sodium salt. 
Tartrazine consists essen tially of trisodium 5-hydroxy-
1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principa l 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-sulf onatophenyl)-4-(4-
sulfonatophenylazo)-H- pyrazole-3-carboxylate 
Chemical formula C 16H9N4Na3O9S2 
Molecular weight 534,37 
Content not less than 85 % total colouring matters 
calculated as the sodium salt Assay 
E1cm1 % 530 at ca 426 nm in aqueous solution 
Description  Light orange powder or granules Appearance of a water  
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 
 4-aminobenzene-1-
sulfonic acid 
 5-oxo-1-(4-
sulfophenyl)-2-pyrazoline-3-carboxylic acid 
 4,4′-
diazoaminodi(benzene sulfonic acid) 
 Tetrahydroxysuccini
c acid  
Total not more than 0,5 % 
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-quinolyl)inda ne-1,3-dione and one third 
2-(2-(6-methylquinolyl))i ndane-1,3-dione. Quinoline 
Yellow consists essentially of  sodium salts of a mixture 
of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together w ith 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 18H9N Na 2O8S2 (principal component) 
Molecular weight 477,38 (principal component) 
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 % sha ll 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 % sha ll be trisodium 2-(2-
quinolyl) indan-1,3-dione-trisulfonate Assay 
E1cm1 % 865 (principal component) at ca 411 nm in 
aqueous acetic acid solution 
Description  Yellow powder or granules 
Appearance of a water 
solution  Yellow 
Identification  
Spectrometry Maximum in aqueous a cetic acid solution of pH 5 at ca 
411 nm 
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 
 2-methylquinoline-
sulfonic acid 
Phthalic acid 
 2,6-dimethyl 
quinoline 
 2,6-dimethyl 
quinoline sulfonic acid  
Total not more than 0,5 % 
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 aci d 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)napht halene-6-sulfonate 
Chemical formula C 16H10N2Na2O7S2 
Molecular weight 452,37 
Content not less than 85 % total colouring matters 
calculated as the sodium salt Assay 
E1cm1 %  555 at ca 485 nm in aqueous solution at pH 7 
Description  Orange-red powder or granules 
Appearance of a water 
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) 
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 carmini c 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 th e colouring principle is 
present in association wi th ammonium, calcium, 
potassium or sodium cations, singly or in combination, 
and these cations may also be present in excess. 
Commercial products may al so contain proteinaceous 
material derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations. 
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-dioxoanthracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid 
Chemical formula C 22H20O13 (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   
Maximum in aqueous ammonia solution at ca 518 nm Spectrometry 
Maximum in dilute hydrochloric solution at ca 494 nm 
for carminic acid 
E1cm1 % 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 essentia lly of disodium 4-hydroxy-
3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium su lphate as the principal 
uncoloured components. 
Azorubine is described as th e 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 20H12N2Na2O7S2 
Molecular weight 502,44 
Content not less than 85 % total colouring matters, 
calculated as the sodium salt Assay 
E1 cm1 % 510 at ca 516 nm in aqueous solution 
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 Not more than 1 % matters 
Organic compounds other 
than colouring matters:  
 4-aminonaphthalene-
1-sulfonic acid 
 4-
hydroxynaphthalene-1-sulfonic acid  
Total not more than 0,5 % 
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 essentia lly 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 20H11N2Na3O10S3 Molecular weight 604,48 
Content not less than 85 % total colouring matters, 
calculated as the sodium salt Assay 
E1 cm1 % 440 at ca 520 nm in aqueous solution 
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 
 3-
hydroxynaphthalene-2,7-disulfonic acid 
 6-
hydroxynaphthalene-2-sulfonic acid 
 7-
hydroxynaphthalene-1,3-disulfonic acid 
 7-
hydroxynaphthalene-1,3-6-trisulfonic acid  
Total not more than 0,5 % 
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 
Ponceau 4R consists essentially of trisodium 2-
hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chlori de and/or sodium sulphate 
as the principal uncoloured components. Ponceau 4R is manufactured by coupling di azotized naphthionic acid 
to G acid (2-naphthol-6,8- disulphonic acid) and converting the coupling produc t to the trisodium salt. Definition  
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 20H11N2Na3O10S3 
Molecular weight 604,48 
Content not less than 80 % total colouring matters, 
calculated as the sodium salt. Assay 
E1 cm1 % 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 
 7-
hydroxynaphthalene-1,3-disulfonic acid 
 3-
hydroxynaphthalene-2,7-disulfonic acid 
 6-
hydroxynaphthalene-2-sulfonic acid 
 7-
hydroxynaphthalene-1,3-6-trisulfonic acid  
Total not more than 0,5 % 
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 essen tially of disodium 2-(2,4,5,7-
tetraiodo-3-oxido-6-oxoxa nthen-9-yl) benzoate 
monohydrate and subsidiary co louring matters together 
with water, sodium chloride and/or sodium sulphate as the principal uncoloured co mponents. Erythrosine is 
manufactured by iodination of fluorescein, the condensation product of re sorcinol 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 20H6I4Na2O5 2H 2O 
Molecular weight 897,88 
Content not less than 87 % total colouring matters, 
calculated as the anhydrous sodium salt Assay 
E1 cm1 %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 mo re than 20 mg/kg 
Organic compounds other 
than colouring matters:  
 Tri-iodoresorcinol Not more than 0,2 % 
 2-(2,4-dihydroxy-
3,5-diodobenzoyl) 
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 e ssentially of disodium 2-
hydroxy-1-(2-methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together w ith 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) napht halene-6-sulfonate 
Chemical formula C 18H14N2Na2O8S2 
Molecular weight 496,42 
Content not less than 85 % total colouring matters, 
calculated as the sodium salt Assay 
E1 cm1 % 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-methylbenezene 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 solu tion 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 esse ntially of the calcium or 
sodium compound of [4-( α-(4-diethylaminophenyl)-5-
hydroxy-2,4-disulfophenyl-methylidene)2,5-cyclohexadien-1-ylidene] di ethylammonium hydroxide 
inner salt and subsidiary colouring matters together with 
sodium chloride and/or sodium sulphate and/or calcium sulphate as the principa l 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-hydr oxy-2,4-disulfophenyl-
methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt Chemical formula Calcium compound: C 27H31N2O7S2Ca1/2 
Sodium compound: C 27H31N2O7S2Na 
Molecular weight Calcium compound: 579,72 
Sodium compound: 582,67 
Content not less than 85 % total colouring matters, 
calculated as the sodium salt Assay 
E1 cm1 % 2 000 at ca 638 nm in aqueous solution at pH 5 
Description  Dark-blue powder or granules 
Appearance of a solution 
in water  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 
 3-hydroxy benzoic 
acid 
 3-hydroxy-4-
sulfobenzoic acid 
 N,N-diethylamino 
benzene sulfonic 
acid  
Total not more than 0,5 % 
Leuco base Not more than 4,0 % 
Unsulfonated primary 
aromatic amines Not more than 0,01 % (calculated as aniline) 
Ether extractable matter From a solu tion 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 accomplished by hea ting indigo (or indigo paste) 
in the presence of sulphuric acid. The dye is isolated and subjected to purification procedures. 
Colour Index No 73015 
EINECS 212-728-8 
Chemical name Disodium 3,3 ′-dioxo-2,2 ′-bi-indolylidene-5,5 ′-
disulfonate 
Chemical formula C 16H8N2Na2O8S2 
Molecular weight 466,36 
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 % Assay 
E1 cm1 % 480 at ca 610 nm in aqueous solution 
Description  Dark-blue powder or granules 
Appearance of a solution 
in water  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 
 5-sulfoanthranilic 
acid 
Anthranilic acid  
Total not more than 0,5 % 
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-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and 
subsidiary colouring matters together with sodium 
chloride and/or sodium su lphate as the principal 
uncoloured components. 
Brilliant Blue FCF is descri bed as the sodium salt. The 
calcium and the potassium salt are also permitted. 
Colour Index No 42090 
EINECS 223-339-8 
Chemical name Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulf onatobenzylamino) 
cyclohexa-2,5-dienylidene)  toluene-2-sulfonate 
Chemical formula C 37H34N2Na2O9S3 
Molecular weight 792,84 
Content not less than 85 % total colouring matters, 
calculated as the sodium salt Assay 
E1 cm1 %1 630 at ca 630 nm in aqueous solution 
Description  Reddish-blue powder or granules 
Appearance of a solution 
in water  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 Phaeophytin 
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 co-ordinated magne sium 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. 
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 (132R,17S,18S)-3-(8-ethyl-132-
methoxycarbonyl-2,7,12,18-tetramethyl-13 ′-oxo-3-
vinyl-131-132-17,18-tetrahydrocyclopenta [at]-
porphyrin-17-yl)propi onate, (Pheophytin a), or as the 
magnesium complex (Chlorophyll a) 
Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-
methoxycarbonyl-2,12,18-trimethyl-13 ′-oxo-3-vinyl-
131-132-17,18-tetrahydrocycl openta[at]-porphyrin-17-
yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b) 
Chemical formula Chlorophyll a (magnesium complex): C 55H72MgN 4O5 
Chlorophyll a: C 55H74N4O5 
Chlorophyll b (magnesium complex): C 55H70MgN 4O6 
Chlorophyll b: C 55H72N4O6 
Molecular weight Chlorophyll a (magnesium complex): 893,51 
Chlorophyll a: 871,22 Chlorophyll b (magnesium complex): 907,49 
Chlorophyll b: 885,20 
Content of total combined  Chlorophylls and their 
magnesium complexes is not less than 10 % Assay 
E1 cm1 % 700 at ca 409 nm in chloroform 
Description  Waxy solid ranging in colour from olive green to dark 
green depending on the content of co-ordinated magnesium 
Identification   
Spectrometry Maximum in chloroform at ca 409 nm 
Purity  
Acetone 
Methyl Ethyl ketone 
Methanol 
Ethanol 
Propan-2-ol 
Hexane Not more than 50 mg/kg, 
singly or in combination Solvent residues 
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 
 
E 140 (ii) CHLOROPHYLLINS  
Synonyms CI Natural Green 5; Sodium Chlorophyllin; Potassium 
Chlorophyllin Definition  The alkali salts of chlorophyllins are obtained by the 
saponification of a solvent extr act of strains of edible 
plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cl eave the cyclopentenyl ring. 
The acid groups are neutrali zed 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 
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 
(chlorophyllin a) 
 and – 3-(10-carboxylato-4- ethyl-3-formyl-1,5,8-
trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b) Chemical name 
Depending on the degree of hydrolysis the 
cyclopentenyl ring may be cl eaved with the resultant 
production of a third carboxyl function. 
Magnesium complexes may also be present. 
Chemical formula Chlorophyllin a (acid form): C 34H34N4O5 
Chlorophyllin b (acid form): C 34H32N4O6 
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 chlorophy llins is not less than 95 % of 
the sample dried at ca 100 °C for 1 hour. 
 E1 cm1 % 700 at ca 405 nm in aqueous solution at pH 9 
 E1 cm1 % 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  
Acetone 
Methyl ethyl ketone 
Methanol 
Ethanol 
Propan-2-ol 
Hexane Not more than 50 mg/kg, singly 
or in combination Solvent residues 
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 
 
E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS  
Synonyms  CI Natural Green 3; Copper Chlorophyll; Copper 
Phaeophytin 
Definition  Copper chlorophylls are obtai ned by addition of a salt 
of copper to the substance obtained by solvent extraction of strains of edib le 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: 23 9-830-5; copper chlorophyll b: 
246-020-5 [Phytyl (132R,17S,18S)-3-(8-ethyl-132-
methoxycarbonyl-2,7,12,18-tetramethyl-13 ′-oxo-3-
vinyl-131-132-17,18-tetrahydrocyclopenta[at]-
porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a) Chemical name 
[Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-
methoxycarbonyl-2,12,18-trimethyl-13 ′-oxo-3-vinyl-
131-132-17,18-tetrahydrocycl openta[at]-porphyrin-17-
yl)propionate] copper (II) (Copper chlorophyll b) 
Chemical formula Copper chlorophyll a: C 55H72Cu N 4O5 
Copper chlorophyll b: C 55H70Cu N 4O6 
Molecular weight Coppe r chlorophyll a: 932,75 
Copper chlorophyll b: 946,73 
Content of total copper ch lorophylls is not less than 
10 %. 
E1 cm1 % 540 at ca 422 nm in chloroform Assay 
E1 cm1 % 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  
Acetone 
Methyl ethyl ketone 
Methanol 
Ethanol 
Propan-2-ol 
Hexane Not more than 50 mg/kg, singly 
or in combination Solvent residues 
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 
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 ch lorophyllins are obtained by 
the addition of copper to the product obtained by the 
saponification of a solvent extr action of strain s of edible 
plant material, grass, lu cerne, and nettle; the 
saponification removes the methyl and phytol ester groups and may partially cl eave the cyclopentenyl ring. 
After addition of copper to the purified chlorophyllins, the acid groups are neutrali zed 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 34H32Cu N 4O5 
Copper chlorophyllin b (acid form): C 34H30Cu N 4O6 
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 ch lorophyllins is not less than 
95 % of the sample dried at 100 °C for 1 h. E1 cm1 % 565 at ca 405 nm in aqueous phosphate buffer 
at pH 7,5 
E1 cm1 % 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   
Acetone 
Methyl ethyl ketone 
Methanol 
Ethanol 
Propan-2-ol 
Hexane Not more than 50 mg/kg, singly 
or in combination Solvent residues 
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 essent ially of sodium N-[4-
(dimethylamino)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-naphtha lenyl)-methylene]2,5-
cyclohexadien-1-ylidene]-N-methylmethanaminium; Sodium 5-[4-dimethylamino- α-(4-
dimethyliminocyclohexa-2,5- dienylidene) benzyl]-6-
hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name). 
Chemical formula C 27H25N2NaO 7S2 
Molecular weight 576,63 
Content not less than 80 % total colouring matters calculated as the sodium salt Assay 
E1 cm1 % 1 720 at ca 632 nm in aqueous solution 
Description  Dark blue or dark green powder or granules 
Appearance of a solution 
in water 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)-benzophenone Not more than 0,1 % 
 3-
hydroxynaphthalene-Not more than 0,2 % 2,7-disulfonic acid 
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 carbohydrates (commercially available 
food grade nutritive sweet eners 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 ma y be employed, with the 
exception of ammonium co mpounds 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 Not more than 50 % phosphoryl cellulose 
Colour intensity1 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 
 
E 150b CAUSTIC SULPHITE CARAMEL  
Synonyms  
Definition  Caustic sulphite caramel is prepared by the controlled 
heat treatment of carbohydrates (commercially available food grade nutritive sweet eners 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 bi sulphite); 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 % 
                                                 
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 610 nm. Colour intensity2 0,05—0,13 
Total nitrogen Not more than 0,3 %3 
Sulphur dioxide Not more than 0,2 %4 
Total sulphur 0,3—3,5 %5 
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 sweet eners 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. 
Colour Index No  
EINECS 232-435-9 
Chemical name  
                                                 
2 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 610 nm. 
3 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. 
4 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. 
5 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. 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 intensity6 0,08—0,36 
Ammoniacal nitrogen Not more than 0,3 %7 
4-methylimidazole Not more than 200 mg/kg 
2-acetyl-4-tetrahydroxy-
butylimidazole Not more than 10 mg/kg8 
Total sulphur Not more than 0,2 %9 
Total nitrogen 0,7—3,3 %10 
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  
                                                 
6 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 610 nm. 
7 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. 
8 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. 
9 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. 
10 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. Synonyms  
Definition  Sulphite ammonia caramel is prepared by the controlled 
heat treatment of carbohydrates (commercially available food grade nutritive sweet eners which are the 
monomers glucose and fructo se 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  
Molecular weight  
Assay  
Description  Dark brown to black liquids or solids 
Identification  
Purity   
Colour bound by DEAE 
cellulose More than 50 % 
Colour intensity11 0,10 - 0,60 
Ammoniacal nitrogen Not more than 0,6 %12 
Sulphur dioxide Not more than 0,2 %13 
4-methylimidazole Not more than 250 mg/kg14 
Total nitrogen 0,3 - 1,7 %15 
                                                 
11 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 610 nm. 
12 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. 
13 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. 
14 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. Total sulphur 0,8 - 2,5 %16 
Nitrogen/sulphur ratio of 
alcohol precipitate 0,7 - 2,7 
Absorbance ratio of 
alcohol precipitate17 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 
 
E 151 BRILLIANT BLACK BN, BLACK PN  
Synonyms  CI Food Black 1 
Brilliant Black PN consists essentially of tetrasodium-4-
acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-napht hylazo] naphthalene-1,7-
disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Definition  
Brilliant Black PN is described as the sodium salt. The 
calcium and the potassium salt are also permitted. 
Colour Index No 28440 
EINECS 219-746-5 
Chemical name Tetrasodium 4-ace tamido-5-hydroxy-6-[7-sulfonato-4-
(4-sulfonatophenylazo)-1-na phthylazo] naphthalene-
1,7-disulfonate 
Chemical formula C 28H17N5Na4O14S4 
Molecular weight 867,69 
Assay Content not less than 80 % total colouring matters 
calculated as the sodium salt 
                                                                                                                                                         
15 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. 
16 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 
0,1 absorbance units. 
17 Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided 
by the absorbance at 560 nm (1 cm cell). E1 cm1 % 530 at ca 570 nm in solution 
Description  Black powder or granules 
Appearance of a solution 
in water 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 % (expre ssed on the dye content) 
Organic compounds other 
than colouring matters:  
 4-acetamido-5-
hydroxynaphthalene-1,7-disulfonic acid 
 4-amino-5-
hydroxynaphthalene-1,7-disulfonic acid 
 8-aminonaphthalene-
2-sulfonic acid 
 4,4′-diazoaminodi-
(benzenesulfonic acid)  
Total not more than 0,8 % 
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 
carbonization of vegetable material such as wood, cellulose residues, peat and coconut and other shells. . 
The highest activity of activ ated carbon thus produced 
is milled by a roller mill and the resulting highly activated powdered carbon is treated by a cyclone. The fine fraction from the cyclone is purified by hydrochloric acid washing, ne utralised 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 dryi ng. 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. 
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% (120oC 4 h)  
Description  Black, odourless powder 
Identification   
Solubility Insoluble in wa ter and organic solvents 
Burning When heated to redne ss 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 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 
Brown HT consists esse ntially 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. Definition  
Brown HT is described as th e 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 27H18N4Na2O9S2 
Molecular weight 652,57 
Assay Content not less than 70 % total colouring matters 
calculated as the sodium salt. 
 E 1 cm1 % 403 at ca 460 nm in aqueous solution at pH 7 
Description  Reddish-brown powder or granules 
Appearance of a water 
solution  Brown 
Identification   
Spectrometry Maximum in water of pH 7 at ca 460 nm 
Purity   
Water insoluble matter Not more than 0,2 % 
Subsidiary colouring Not mo re than 10 % (TLC method) matters 
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. D iluted and stabilised 
preparations may have differe nt trans-cis isomer ratios. 
Colour index No 40800 
EINECS 230-636-6 
Chemical name Beta-carotene; beta, beta-carotene 
Chemical formula C 40H56 
Molecular weight 536,88 
Assay Not less than 96 % total colouring matters (expressed 
as beta-carotene) 
E 1 %
1 cm 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 
 
E 160 a (ii) PLANT CAROTENES  
Synonyms  CI Food Orange 5 
Definition  Mixed carotenes are obtained  by solvent extraction of 
strains of edible plants, ca rrots, 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
18, dichloromethane and 
carbon dioxide. 
Colour index No 75130 
EINECS 230-636-6 
Chemical name  
Chemical formula Beta-carotene: C 40H56 
Molecular weight Beta-carotene: 536,88 
Assay Content of carotenes (cal culated 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 %
1 cm 2 500 at approximately 440 nm to 457 nm in 
cyclohexane 
Description   
Identification   
Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and 
                                                 
18 Benzene not more than 0,05 % v/v. 470 nm to 486 nm 
Purity   
Acetone 
Methyl ethyl ketone 
Methanol 
Propan-2-ol 
Hexane 
Ethanol Not more than 50 mg/kg, 
singly or in combination Solvent residues 
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 aceta te followed by isopropyl 
alcohol 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. 
Colour Index No 40800 
EINECS 230-636-6 
Chemical name Beta-carotene; beta,beta-carotene 
Chemical formula C 40H56 
Molecular weight 536,88 
Assay Not less than 96 % total colouring matters (expressed 
as beta-carotene) 
E 1 %
1 cm 2 500 at approximately 440 nm to 457 nm in 
cyclohexane 
Description  Red, brownish-red or purpl e-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   
Ethyl acetate 
Ethanol Not more than 0,8 %, singly or in 
combination 
Isobutyl acetate: Not more than 1,0% Solvent residues 
Isopropyl alcohol: 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 
Definition  Mixed carotenes may also be produced from strains of 
the algae Dunaliella salina , grown in large saline lakes 
located in Whyalla, South Australia. 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, zeaxanthin and beta-cryptoxanthin may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material. 
Colour Index No 75130 
EINECS  Chemical name  
Chemical formula Beta-Carotene: C 40H56 
Molecular weight Beta-Carotene: 536,88 
Assay Content of carotenes (cal culated as beta-carotene) is 
not less than 20 % 
E 1 %
1 cm 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 extr action 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 bixi n 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, anna tto 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 
 Norbixin: 9 ′Cis-6,6′-diapocarotene-6,6 ′-dioic 
acid 9′-Trans-6,6 ′-diapocarotene-6,6 ′-
dioic acid 
Chemical formula Bixin: C 25H30O4 
 Norbixin: C 24H28O4 
Molecular weight Bixin: 394,51 
 Norbixin: 380,48 
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 cm1 % 2 870 at ca 502 nm in chloroform Assay 
Norbixin: E 1 cm1 % 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 d ilute KOH solution at ca 
482 nm 
Purity  
Acetone 
Methanol 
Hexane not more than 50 mg/kg, singly 
or in combination Solvent residues 
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 seed s 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, anna tto 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 
 Norbixin: 9 ′Cis-6,6′-diapocarotene-6,6 ′-dioic 
acid 9′-Trans-6,6 ′-diapocarotene-6,6 ′-
dioic acid 
Chemical formula Bixin: C 25H30O4 
 Norbixin: C 24H28O4 
Molecular weight Bixin: 394,51 
 Norbixin: 380,48 
Contains not less than 0, 1 % of total carotenoids 
expressed as norbixin Assay 
Norbixin: E 1 cm1 % 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 d ilute 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 ma jor single one being bixin, 
which may be present in bot h cis- and trans- forms. 
Thermal degradation products of bixin may also be present. 
  
Colour Index No 75120 
EINECS Annatto: 215-735-4, anna tto 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 
 Norbixin: 9 ′Cis-6,6′-diapocarotene-6,6 ′-dioic 
acid 
9′-Trans-6,6 ′-diapocarotene-6,6 ′-
dioic acid 
Chemical formula Bixin: C 25H30O4 
 Norbixin: C 24H28O4 
Molecular weight Bixin: 394,51 
 Norbixin: 380,48 
Assay Contains not less than 0,1 % of total carotenoids 
expressed as bixin Bixin: E 1 cm1 % 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 d ilute 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 capsanthin 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, propane-2-oland 
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,k-
carotene-6-one 
Capsorubin: (3S, 3 ′S, 5R, 5R ′)-3,3′-dihydroxy-k,k-
carotene-6,6 ′-dione 
Chemical formula Capsanthin: C 40H56O3 
Capsorubin: C 40H56O4 
Molecular weight Capsanthin: 584,85 Capsorubin: 600,85 
Paprika extract: content not less than 7,0 % carotenoids 
Capsanthin/capsorubin: not  less than 30 % of total 
carotenoids Assay 
E1 cm1 % 2 100 at ca 462 nm in acetone 
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   
Ethyl acetate 
Methanol 
Ethanol 
Acetone 
Hexane 
Propane-2-ol Not more than 50 mg/kg, singly or 
in combination Solvent residues 
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 mixt ure of geometric isomeres 
of lycopenes and is produced by the Wittig condensation of synthetic intermediates 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-lyc opene, (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 40H56 
Molecular weight 536.85 
Assay Not less than 96% total lycopenes (not less than 70% 
all-translycopene) 
E1 cm1 %at 465 - 475 nm in hexane (for 100% pure 
all-translycopen) is 3450 
Description Red crystalline powder 
Identification  
Spectrophotometry A solution in hexane  shows an absorption maximum at 
approximately 470 nm 
Test for carotenoids The colour of th e solution of the sample in acetone 
disappears after successive a dditions 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 oxid e 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 preparations only)  
Lead Not more than 1 mg/kg 
 
ii Lycopene from red tomatoes  
Synonyms Natural Yellow 27  
Definition Lycopene is obtained by so lvent extraction of red 
tomatoes ( Lycopersicon 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, hexane. The major colouring principle of tomatoes is lycopene, minor amounts of other car otenoid pigments may be 
present. Besides the colour  pigments the product may 
contain oil, fats, waxe s 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-
2,6,8,10,12,14,16,18,20,22,24,26,30-
dotriacontatridecaene 
Chemical formula C 40H56 
Molecular weight 536.85 
Assay E1 cm1 % at 465 - 475 nm in hexane (for 100% pure all-
trans-lycopene) is 3450. 
Content not less than 5% total colouring matters 
Description Dark red viscous liquid 
Identification  
Spectrophotometry  
Maximum in hexane at ca 472 nm 
Purity   
Solvent residues Propane − 2 − ol 
Hexane Not more than 50 mg/kg, Acetone 
Ethanol Methanol Ethylacetate singly or in combination 
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 cr ystallization and filtration. It 
consists predominantly of all-tr ans-lycopene. It also contains 
minor quantities of other carotenoids. Isopropanol and isobutyl acetate are the only solv ents used in the manufacture. 
Commercial lycopene prepara tions 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 C40H56 
Molecular weight 536.85 
Assay  Not less than 95% total lycope nes and not less than 90% all-
trans-lycopene of all colouring matters E
1 cm1 % at 465 - 475 nm in hexane  (for 100% pure all-trans-
lycopene) is 3450  
Description  Red crystalline powder  
Identification   
Spectrophotometry A solution in hexane shows an absorption maximum at 
approximately 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%  Is clear and has intensive red-orange colour solution in chloroform   
Purity   
Loss on drying  Not more than 0.5% (40oC, 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 preparations 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 to predominantly all trans 
isomer of β-apo-8′-carotenal together with minor 
amounts of other carotenoids . Diluted and stabilized 
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 differe nt 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 30H40O 
Molecular weight 416,65 
Not less than 96 % of total colouring matters Assay 
E1 cm1 % 2 640 at 460—462 nm in cyclohexane 
Description  Dark violet crystals with me tallic 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 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, etha nol, 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 40H56O2 
Molecular weight 568,88 
Content of total colouring matter not less than 4 % 
calculated as lutein Assay 
E1 cm1 % 2 550 at ca 445 nm in chloroform/ethanol 
(10 + 90) or in hexane/eth anol/acetone (80 + 10 + 10) 
Description  Dark, yellowish brown liquid 
Identification   
Spectrometry Maximum in chloroform/ethanol (1:9) at ca 445 nm 
Purity  Acetone 
Methyl ethyl ketone 
Methanol 
Ethanol 
Propan-2-ol Solvent residues 
Hexane Not more than 50 mg/kg, singly 
or in combination 
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 stabilized forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fa ts or oils, emulsions and 
water dispersible powders. These preparations may 
have different cis/trans isomer ratios. 
Colour Index No 40850 
EINECS 208-187-2 
Chemical name β-Carotene-4,4 ′-dione; canthaxanthin; 4,4 ′-dioxo-β-
carotene 
Chemical formula C 40H52O2 
Molecular weight 564,86 
Not less than 96 % of total colouring matters (expressed as canthaxanthin) 
E1 cm1 % 2 200 at ca 485 nm in chloroform  
 at 468—472 nm in cyclohexane Assay 
 at 464—467 nm in petroleum ether 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 cant haxanthin: 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 
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 subs equent 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) a nd degradation products of 
betalaines (light brown) may be present. Definition  
Besides the colour pigmen ts 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 th e 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-di hydro-6-hydroxy-1H-indol-1-yl)ethenyl)-2,3-dihydro-2,6- pyridine-dicarboxylic 
acid; 1-(2-(2,6-dicar boxy-1,2,3,4-tetrahydro-4-
pyridylidene)ethylidene)-5- β-D-glucopyranosyloxy)-6-
hydroxyindolium-2-carboxylate 
Chemical formula Betanin: C 24H26N2O13 
Molecular weight 550,48 
Content of red colour (expr essed as betanine) is not 
less than 0,4 % Assay 
E1 cm1 % 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 nitr ate 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 subseq uent concentration and /or 
purification if necessary. Th e 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 anthocyanin. 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 (delphinidin); 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 chlori de (pelargonidin) 
Chemical formula Cyanidin: C 15H11O6Cl 
Peonidin: C 16H13O6Cl 
Malvidin: C 17H15O7Cl 
Delphinidin: C 15H11O7Cl 
Petunidin: C 16H13O7Cl 
Pelargonidin: C 15H11O5Cl 
Molecular weight Cyanidin: 322,6 
Peonidin: 336,7 Malvidin: 366,7 Delphinidin: 340,6 Petunidin: 352,7 
Pelargonidin: 306,7 
Assay E 1 cm1 % 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   
Methanol Solvent residues 
 Ethanol Not more than 50 mg/kg 
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 
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 effervescence in diluted acetic acid, in diluted hydrochloric acid and in d iluted nitric acid, and the 
resulting solutions, after bo iling, 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) 
Copper (as Cu) 
Chromium (as Cr) 
Zinc (as Zn) 
Barium (as Ba)  
Not more than 100 mg/kg, singly or in combination 
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 dioxi de 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 tit anium 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 specia lised patented process.  
Rutile titanium dioxide, platelet form is manufactured 
by subjecting titanium dioxi de (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 
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 solv ents. Dissolves 
slowly in hydrofluoric 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 th an 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 hyd roxides 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 prim arily 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 
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 Oxid e Yellow: FeO(OH) · H2O 
Iron Oxide Red: Fe2O3 Iron Oxide Black: FeO.Fe2O3 
Molecular weight 88,85: FeO(OH) 
159,70: Fe2O3 231,55: FeO.Fe2O3 
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 wate r and in organic solvents 
Soluble in concentrated mineral acids 
Purity   
Water soluble matter Not more than 1,0 % 
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 By total dissolution 
 
E 173 ALUMINIUM  
Synonyms  CI Pigment Metal  
Definition  Aluminium powder is composed of finely divided 
particles of aluminium. Th e grinding may or may not 
be carried out in the presen ce of edible vegetable oils 
and/or food additive quality fa tty acids. It is free from admixture with substances ot her than edible vegetable 
oils and/or food additive quality fatty acids. 
Colour Index No 77000 
EINECS 231-072-3 
Chemical name Aluminium 
Chemical formula Al 
Atomic weight 26,98 
Assay Not less than 99 % calculate d 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 hydrochloric 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 pow der 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 
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 % 
Copper Not more than 4 % After complete 
dissolution 
 
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-n aphthalene-carboxylate 
Chemical formula C 18H12CaN 2O6S 
Molecular weight 424,45 
Content not less than 90 % total colouring matters Assay 
E1 cm1 % 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 solu tion 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 200 SORBIC ACID  
Synonyms  Definition  
EINECS 203-768-7 
Chemical name Sorbic acid;  Tr ans, trans-2,4-hexadienoic acid 
Chemical  formula C 6H8O2 
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 character istic 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 An isopropanol solu tion (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 6H7O2K 
Molecular weight 150,22 
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 aci d isolated by acidification 
and not recrystallized 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 2CO 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 12H14O4Ca 
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 sulphuric acid desiccator Melting range of sorbic aci d isolated by acidification 
and not recrystallized 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 
 
E 210 BENZOIC ACID 
Synonyms  
Definition  
EINECS 200-618-2 
Chemical name Benzoic acid; Benzenecarboxylic acid; 
Phenylcarboxylic acid 
Chemical formula C 7H6O2 
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 th at of a reference liquid 
containing 0,2 ml of cobalt chloride TSC
19, 0,3 ml of 
ferric chloride TSC20, 0,1 ml of copper sulphate 
TSC21 and 4,4 ml of water 
                                                 
19 Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl 2·6H 2O 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-bottomed flask containing  250 ml of iodine solution, add 
5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the 
precipitate is completely dissolved, titrate the liberated  iodine with sodium thiosulphate (0,1 N) in the 
presence of starch TS(*). 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl
2·6H 2O. 
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 2O per ml. 
20 Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture 
of 25 ml of hydrochloric acid and 97 5 ml of water to give a total volume of 1 litre. Place 10 ml of this 
solution in a round-bottomed flask containing 250 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 
thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl
3·6H 2O. Adjust final volume of solution by the Polycyclic acids On fractional acidification of a neutralized solution of 
benzoic acid, the first prec ipitate must not have a 
different melting point from th at 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 
 
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 7H5O2Na 
Molecular weight 144,11 
Assay Not less than 99 % of C 7H5O2Na, after drying at 
105 °C for four hours 
Description A white, almost odourless, crystalline powder or 
granules 
Identification  
Solubility Freely soluble in wate r, sparingly soluble in ethanol 
Melting range for benzoic 
acid Melting range of benzoic acid isolated by 
acidification and not recr ystallized 121,5 °C to 
123,5 °C, after drying in a sulphuric acid desiccator 
                                                                                                                                                         
addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of 
FeCl 3·6H 2O per ml. 
21 Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO 4·5H 2O in a sufficient 
quantity of a mixture of 25 ml of hydrochloric acid an d 975 ml of water to give a total volume of 1 litre. 
Place 10 ml of this solution in a round-bottomed flask containing 250 ml of i odine solution, add 40 ml 
of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated 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 2O. 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 2O per ml. 
(*) Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluab le starch) with 5 ml of water; to 
the resulting paste 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, filter. The starch must be freshly prepared. 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 (neutralized) solution 
of sodium benzoate, the firs t 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 Neutralization 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 
Chemical formula C 7H5KO 2·3H 2O 
Molecular weight 214,27 Assay Content not less than 99 % C 7H5KO 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 recr ystallized 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 (neutralized) solution 
of potassium benzoate, the first precipitate must not 
have a different melting range  from that of benzoic 
acid 
Acidity or alkalinity Neutralization 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 
Anhydrous: C 14H10O4Ca 
Monohydrate: C 14H10O4Ca·H 2O Chemical formula 
Trihydrate: C 14H10O4Ca·3H 2O 
Anhydrous: 282,31 
Monohydrate: 300,32 Molecular weight 
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 recr ystallized 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 acids 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 (neutralized) solution 
of calcium benzoate, the firs t precipitate must not be a 
different melting range from that of benzoic acid 
Acidity or alkalinity Neutralization 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 
Chemical formula C 9H10O3 
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 °C - 118 °C 
Test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid isolated by 
acidification and not recrys tallized: 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 9H9O3Na 
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 desiccator) 
Sulphated ash 37 to 39 % 
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 8H8O3 
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 8H7O3Na 
Molecular weight 174,15 
Assay Content not less than 99,5 % on the anhydrous basis 
Description White, hygroscopic powder 
Identification  
Melting point 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 indi cator) 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 dioxid e; 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 
 
E 221 SODIUM SULPHITE 
Synonyms  
Definition  
EINECS 231-821-4 
Chemical name Sodium sulph ite (anhydrous or heptahydrate) 
Anhydrous: Na 2SO 3 Chemical formula 
Heptahydrate: Na 2SO 37H2O 
Anhydrous: 126,04 Molecular weight 
Heptahydrate: 252,16 
Anhydrous: Not less than 95 % of Na 2SO 3 
and not less than 48 % of SO 2 Assay 
Heptahydrate: Not less than 48 % of Na 2SO 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 
 
E 222 SODIUM BISULPHITE 
Synonyms  
Definition   
EINECS 231-921-4 
Chemical name Sodium bisul phite; 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 
Test for sodium Passes test 
pH  2,5 - 5,5 (10 % aqueous solution) 
Purity  
Iron Not more than 10 mg/kg of Na 2SO 3 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 223 SODIUM METABISULPHITE 
Synonyms  Pyrosulphite; Sodium pyrosulphite 
Definition  
EINECS 231-673-0 
Chemical name Sodium disulphi te; Disodium pentaoxodisulphate 
Chemical formula Na 2S2O5 
Molecular weight 190,11 
Assay Content not less than 95 % Na 2S2O5 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 disulphi te; Potassium pentaoxo disulphate 
Chemical formula K 2S2O5 
Molecular weight 222,33 
Assay Content not le ss than 90 % of K 2S2O5 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 2O 
Molecular weight 156,17 Assay Content not less than 95 % of CaSO 3·2H 2O 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 
 
E 227 CALCIUM BISULPHITE 
Synonyms  
Definition  
EINECS 237-423-7 
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 
 
E 228 POTASSIUM BISULPHITE 
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  
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 143H230N42O37S7 
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-     
mannopyranosyloxy)-1,3,26-tr ihydroxy-12-methyl-
10-oxo-6,11,28-trioxatricyclo[22.3.1.05,7]octacosa-8,14,16,18,20-pentaene-25-carboxylic acid. Chemical formula C 33H47O13N 
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 crys tals 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 
pH 5,5 - 7,5 (1 % w/v solution in previously neutralized 
mixture of 20 parts dimethylformamide and 80 parts of water) 
Specific rotation [ α]D20 = + 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 2O5, 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  colonies per gram 
 E 239 HEXAMETHYLENE TETRAMINE 
Synonyms  Hexamine; Methenamine 
Definition   
EINECS 202-905-8 
Chemical name 1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, 
hexamethylenetetramine 
Chemical formula C 6H12N4 
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 2O5 
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 
 
E 242 DIMETHYL DICARBONATE Synonyms  DMDC; Dimethyl pyrocarbonate 
Definition   
EINECS 224-859-8 
Chemical name Dimethyl dicarbona te; Pyrocarbonic acid dimethyl 
ester 
Chemical formula C 4H6O5 
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/cm3 
Infrared 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 
 
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 basis22 
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) 
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 basis23 
                                                 
22 May only be sold in a mixture with salt or a salt substitute. 
23 May only be sold in a mixture with salt or a salt substitute. 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 
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 hydr oxide and nitric acid in 
stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeti ng these specifications may 
contain nitric acid in exce ssive 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 
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 2H4O2 
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 No t lower than 14,5 °C 
Purity   
Non-volatile residue No t more than 100 mg/kg 
Formic acid, formates and 
other oxidizable 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 wa ter and add 0,1 ml of 0,1 N 
potassium permanganate. The pink colour does not change to brown within 30 minutes 
Arsenic Not more than 1 mg/kg 
Lead Not more than 0,5 mg/kg 
Mercury Not more than 1 mg/kg 
 
E 261 POTASSIUM ACETATE Synonyms   
Definition   
EINECS 204-822-2 
Chemical name Potassium acetate 
Chemical formula C 2H3O2K 
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 oxidizable 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 (i) SODIUM ACETATE 
Synonyms   
Definition   
EINECS 204-823-8 
Chemical name Sodium acetate Chemical formula C 2H3NaO 2·nH 2O (n = 0 or 3) 
Anhydrous: 82,03 Molecular weight 
Trihydrate: 136,08 
Assay Content (for both of anhydrous and trihydrate form) 
not less than 98,5 % on the anhydrous basis 
Anhydrous: White, odourless, granular, 
hygroscopic powder Description  
Trihydrate: Colourless, transparent crystals 
or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air 
Identification   
pH  8,0 – 9,5 (1 % aqueous solution) 
Test for acetate  Passes test 
Test for sodium  Passes test 
Purity   
Anhydrous: Not more than 2 % (120 °C, 4 
hours) Loss on drying 
Trihydrate: Between 36 and 42 % (120 °C, 4 
hours) 
Formic acid, formates and other oxidizable 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 4H7NaO 4·nH 2O (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 crystallin e 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 oxidizable 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 
Chemical name Calcium acetate 
Anhydrous: C 4H6O4Ca Chemical formula 
Monohydrate: C 4H6O4Ca·H 2O Anhydrous: 158,17 Molecular weight 
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 monohydrate) 
Water insoluble matter Not more than 0,3 % 
Formic acid, formates and 
other oxidizable 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 (C3H6O3) and 
lactic acid lactate (C6H10O 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 hydr olyzes to lactic acid. 
EINECS 200-018-0 Chemical name Lactic aci d; 2-Hydroxypropionic acid; 1-
Hydroxyethane-1-carboxylic acid 
Chemical formula C 3H6O3 
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 
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 % aqu eous 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 3H6O2 
Molecular weight 74,08 Assay Content not less than 99,5 % 
Description  Colourless or slightly yell owish, 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 3H5O2Na 
Molecular weight 96,06 
Assay Content not less than 99 % after drying for two hours 
at 105 °C 
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 insolubles 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 6H10O4Ca 
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 insolubles 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 
Chemical name Potassium propionate; Potassium propanoate 
Chemical formula C 3H5KO 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 substances 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 3BO 3 
Molecular weight 61,84 
Assay Content not less than 99,5 % 
Description  Colourless, odourless, transp arent crystals or white 
granules or powder; sligh tly unctuous to the touch; 
occurs in nature as the mineral sassolite 
Identification   
Melting point At approximately 171 °C 
Burns with a nice green 
flame  
pH  3,8 – 4,8 (3,3 % aqueous solution) 
Purity   
Peroxides No colour devel ops 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 285 SODIUM TETRABORATE (BORAX) 
Synonyms  Sodium borate 
Definition   EINECS 215-540-4 
Chemical name Sodium tetrabor ate; Sodium biborate; Sodium 
pyroborate; Anhydrous tetraborate 
Chemical formula Na 2B4O7 
Na2B4O7·10H 2O 
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 devel ops 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 pressurized cylinders or bul k 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) 
Reducing substances, hydrogen phosphide and sulphide 915 ml of gas bubbled through 25 ml of ammoniacal 
silver nitrate reagent to wh ich 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  hydroxybutanedio ic acid; hydroxysuccinic acid  
Chemical formula  C 4H6O5  
Molecular weight  134,09  
Assay  Content not less than 99,0 %  
Description   White or nearly white crysta lline powder or granules  
Identification   Melting range  127 °C - 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-butened ioic acid; trans-1,2-ethylene-
dicarboxylic acid  
Chemical formula  C 4H4O4  
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 °C - 302 °C (clo sed 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) 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-Aascorbic acid, L(+)- ascorbic acid 
Definition   
EINECS 200-066-2 
Chemical name L-ascorbic acid ; Ascorbic acid; 2,3-Didehydro-L-
threo-hexono-1,4-lact one; 3-Keto-L-
gulofuranolactone 
Chemical formula C 6H8O6 
Molecular weight 176,13 
Assay contains not less than 99 % of C 6H8O6 after drying in 
a vacuum desiccator over sulphuric acid for 24 hours,  
Description  White to pale yellow, od ourless 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]D20 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 ascorbat e; Sodium L-ascorbate; 2,3-
Didehydro-L-threo-hexono-1,4-lactone sodium enolate; 3-Keto-L-gulofurano-lactone sodium enolate 
Chemical formula C 6H7O6Na 
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
6H7O6Na 
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]D20 between + 103° and + 106° (10 % w/v aqueous 
solution) 
Purity  
Loss on drying Not more than 0,25 % (i n 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 ascorbat e dihydrate; Calc ium salt of 2,3-
didehydro-L-threo-hexo no-1,4-lactone dihydrate 
Chemical formula C 12H14O12Ca·2H 2O 
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]D20 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 
 
E 304 (i) ASCORBYL PALMITATE 
Synonyms  L-ascorbyl palmitate 
Definition   
EINECS 205-305-4 
Chemical name Ascorbyl palm itate; L-ascorbyl palmitate; 2,3-
didehydro-L-threo-hexono-1,4- lactone-6-palmitate; 6-
palmitoyl-3-keto-L-gulofuranolactone 
Chemical formula C 22H38O7 
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]D20 between + 21° and + 24° (5 % w/v in methanol 
solution) 
Purity  
Loss on drying Not more than 2,0 % (vacuum oven, 56 °C - 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-s tearate; 6-stearoyl-3-
keto-L-gulofuranolactone 
Chemical formula C 24H42O7 
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 °C - 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 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-ς-
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 ta ste. May show a slight 
separation of wax-like constituents in microcrystalline form 
Identification   
By suitable gas liquid 
chromatographic method  
Specific rotation [ α]D20 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 29H50O2 
Molecular weight 430,71 
Assay Content not less than 96 % 
Description  Slightly yellow to amber, nearly odourless, clear, 
viscous oil which oxidizes a nd darkens on exposure to air or light 
Identification   
Solubility Insoluble in water, fr eely soluble in ethanol, miscible 
in ether 
Spectrophotometry In absolute ethanol  the maximum absorption is about 
292 nm 
Specific rotation [ α]D25 0° ± 0,05° (1 in 10 solution in chloroform) 
Purity  
Refractive index n D20 1,503 — 1,507 
Specific absorption 1cm1%E 
in ethanol 1cm1%E (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 28H48O2 
Molecular weight 416,69 
Assay Content not less than 97 % 
Description  Clear, viscous, pale yell ow oil which oxidizes 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 1cm1%E 
in ethanol 1cm1%E (298 nm) between 91 and 97 
1cm1%E (257 nm) between 5,0 and 8,0 
Refractive index n D20 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 27H46O2 
Molecular weight 402,7 
Assay Content not less than 97 % 
Description  Clear, viscous, pale yellow ish or orange oil which 
oxidizes and darkens on e xposure to air or light 
Identification   
Spectrometry Maximum absorptions in absolute ethanol at about 
298 nm and 257 nm 
Purity   
Specific absorption 1cm1%E 
in ethanol 1cm1%E (298 nm) between 89 and 95 
1cm1%E (257 nm) between 3,0 and 6,0 Refractive index n D20 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; Propy l ester of gallic acid; n-propyl 
ester of 3,4,5-trih ydroxybenzoic acid 
Chemical formula C 10H12O5 
Molecular weight 212,20 
Assay Content not less than 98 % on the anhydrous basis 
Description  White to creamy-white, cr ystalline, 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 1cm1%E (275 nm) not less than 485 and not more than 1cm1%E520 
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 
Chemical name Octyl gallate; Octyl ester of gallic acid; n-octyl ester 
of 3,4,5-trihydroxybenzoic acid 
Chemical formula C 15H22O5 
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, fr eely soluble in ethanol, ether and 
propane-1,2-diol 
Melting range Between 99 °C and 1 02 °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 1cm1%E (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-
trihydroxybenzoic acid; Dodecyl ester of gallic acid 
Chemical formula C 19H30O5 
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, fr eely 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) 
Chlorinated organic 
compound Not more than 100 mg/kg (as Cl) 
Specific absorption  in 
ethanol 1cm1%E (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-Eryt hro-hex-2-enoic acid γ-lactone; Isoascorbic 
acid; D-Isoascorbic acid 
Chemical formula C 6H8O6 
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]25
D10 % (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 isoascorba te; Sodium D-isoascorbic acid; 
Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone; 3-keto-D-gulofuran o-lactone sodium enolate 
monohydrate 
Chemical formula C 6H7O6Na·H 2O 
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 
Description  White crystalline solid 
Identification   
Solubility  Freely soluble in wa ter, 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]25
D10 % (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-BUTYLHY DROQUINONE (TBHQ) 
Synonyms  TBHQ 
Definition   
EINECS 217-752-2 
Chemical name Tert-butyl-1,4-ben zenediol 2-(1,1-Dimethylethyl)-1,4-
benzenediol 
Chemical formula C 10H14O2 
Molecular weight 166,22 
Assay Content not less than 99 % of C 10H14O2 
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 
 
E 320 BUTYLATED HYDRO XYANISOLE (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 11H16O2  
Molecular weight  180,25  
Assay  Content not le ss than 98,5 % of C 11H16O2 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 oC and 63 oC  
Colour reaction  Passes test for phenol groups  
Purity   
Sulphated ash  Not more than 0,05 % after calcination at 800 ± 25 oC  
Phenolic impurities  Not more than 0,5 %  
Specific absorption   
1cm1%E (290 nm) not less than 190 and not more than 
210  
 
1cm1%E (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 HYDRO XYTOLUENE (BHT) 
Synonyms  BHT 
Definition   EINECS 204-881-4 
Chemical name 2,6-Ditertiary-butyl- p-cresol; 4-Methyl-2,6-
ditertiarybutylphenol 
Chemical formula C 15H24O 
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 
Absorbance maximum The absorption in the range 230 to 320 nm of a 2 cm 
layer of a 1 in 100 000 so lution 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 
1cm1%E (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 proced ures from animal or 
vegetable foodstuffs; they also include hydrolysed products obtained throug h the use of harmless and appropriate enzymes. The fi nal 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: ligh t 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 °C—
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 % 
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 3H5NaO 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, characteristic odour 
Identification   
Test for lactate Passes test 
Test for potassium Passes test 
pH  6,5 to 7,5 (20 % aqueous solution) 
Purity   
Acidity Not more than 0,5 % af ter 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 lactat e; Potassium 2-hydroxypropanoate 
Chemical formula C 3H5O3K 
Molecular weight 128,17 (anhydrous) 
Assay Content not less than 57 % and not more than 66 % 
Description  Slightly viscous, almost odourless clear liquid. 
Odourless, or with a s light, 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 po tassium 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 dilactat e; Calcium dil actate hydrate; 2-
Hydroxypropanoic acid calcium salt 
Chemical formula (C 3H5O2)2 Ca·nH 2O (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 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, 
fermentation of carbohydrat e 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-Hydroxytricarballytic acid 
Chemical formula (a) C6H8O7 (anhydrous) 
(b) C6H8O7·H2O (monohydrate) 
Molecular weight (a) 192,13 (anhydrous) 
(b) 210,15 (monohydrate) 
Assay Citric acid may be anhy drous or it may contain 1 
molecule of water. Citric acid contains not less than 99,5 % of C
6H8O7, 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 monohydrat e 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 samp le 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) 
 
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-propanetricarboxylic acid 
Chemical formula (a) C6H7O7Na (anhydrous) 
b) C6H7O7Na·H2O (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 hours) 
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-
propanetricarboxylic acid; Dis odium salt of citric acid 
with 1,5 molecules of water 
Chemical formula C 6H6O7Na2·1,5H 2O 
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) 
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-
propanetricarboxylic acid; Tr isodium salt of citric 
acid, in anhydrous, dihydr ate or pentahydrate form 
Anhydrous: C 6H5O7Na3 Chemical formula 
Hydrated: C 6H5O7Na3·nH 2O (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   
Anhydrous: not more than 1,0 % (180 °C, 18 hours) 
Dihydrate: 10,0 to 13,0  % (180 °C, 18 hours) Loss of drying 
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 c itrate; Monopotassium salt of 2-
hydroxy-1,2,3-propanetricar boxylic acid; Anhydrous 
monopotassium salt of citric acid 
Chemical formula C 6H7O7K 
Molecular weight 230,21 
Assay Content not less than 99 % on the anhydrous basis 
Description  White, hygroscopic, granul ar powder or transparent 
crystals 
Identification   
Test for citrate and for 
potassium 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 citrat e; Tripotassium salt of 2-hydroxy-
1,2,3-propanetricarboxylic acid; Monohydrated tripotassium salt of citric acid 
Chemical formula C 6H5O7K3·H2O 
Molecular weight 324,42 
Assay Content not less than 99 % on the anhydrous basis 
Description  White, hygroscopic, granul ar 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 
 
E 333 (i) MONOCALCIUM CITRATE 
Synonyms  Monobasic calcium citrate 
Definition   
EINECS  Chemical name Monocalcium citrate; Monocalcium salt of 2-
hydroxy-1,2,3-propanetricarboxylic acid; Monohydrate monocalcium salt of citric acid 
Chemical formula (C 6H7O7)2Ca·H 2O 
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 cal cium 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-
propanetricarboxylic acid; Tr ihydrated dicalcium salt 
of citric acid 
Chemical formula (C 6H7O7)2Ca2·3H 2O 
Molecular weight 530,42 
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  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 cal cium 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 citrat e; Tricalcium salt of 2-hydroxy-
1,2,3-propanetricarboxylic acid; Tetrahydrated 
tricalcium salt of citric acid 
Chemical formula (C 6H6O7)2Ca3·4H 2O 
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 
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 cal cium 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-dihydroxysuccinic acid 
Chemical formula C 4H6O6 
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 optical rotation  [ α] 20
D between + 11,5° and + 13,5° (20 % w/v 
aqueous solution) 
Purity  
Loss on drying Not more than 0,5 % (over P 2O5, 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; 
Monohydrated monosodium salt of L-(+)-tartaric acid 
Chemical formula C 4H5O6Na·H 2O 
Molecular weight 194,05 
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 
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 
(+)-2,3-dihydroxybutanedioic acid; Dihydrated disodium salt of L-(+)-tartaric acid 
Chemical formula C 4H4O6Na2·2H 2O 
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 monopotassi um salt of L-(+)-tartaric acid; 
Monopotassium salt of L-2,3-dihydroxybutanedioic acid 
Chemical formula C 4H5O6K 
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 4H4O6K2·½H 2O 
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 
 
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 4H4O6KNa·4H 2O 
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 3PO 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 
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 2PO 4 
Monohydrate: NaH 2PO 4 · H 2O 
Dihydrate: NaH 2PO 4 · 2H 2O 
Molecular weight Anhydrous: 119,98 
Monohydrate: 138,00 Dihydrate: 156,01 
Assay After drying at 60 °C fo r one hour and then at 105 °C 
for four hours, contains  not less than 97 % of 
NaH 2PO 4 
P2O5 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 substances 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 (ii) DISODIUM PHOSPHATE 
Synonyms  Disodium monophosphate; Secondary sodium 
phosphate; Disodium orthophosphate;  
Definition   
EINECS 231-448-7 
Chemical name Disodium hydrogen monophosphate; Disodium 
hydrogen orthophosphate 
Anhydrous:Na 2HPO 4 Chemical formula 
Hydrate: Na 2HPO 4 · nH 2O (n = 2,7 or 12) 
Molecular weight 141,98 (anhydrous) 
Assay After drying at 40 °C fo r three hours and subsequently 
at 105 °C for five hours, co ntains not less than 98 % 
of Na 2HPO 4 
P2O5 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 heptahydr ate: 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 substances 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 orthophosphate 
Definition  Trisodium phosphate is obtained from aqueous 
solutions and crystallises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H
2O. 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 orthophosphate 
Chemical formula Anhydrous: Na 3PO 4 
Hydrated: Na 3PO 4 nH 2O (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 th e dodecahydrate, contain not 
less than 97,0 % of Na 3PO 4 calculated on the dried 
basis. Sodium phosphate dodecahydrate contains not less than 92,0 % of Na
3PO 4 calculated on the ignited basis 
P2O5 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 substances 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 dih ydrogen phosphate; Monopotassium 
dihydrogen orthophosphate; Monopotassium dihydrogen monophosphate 
Chemical formula KH 2PO 4 Molecular weight 136,09 
Assay Content not less than 98, 0 % after drying at 105 °C 
for four hours 
P2O5 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 substances 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 phosphate; Dipotassium hydrogen orthophosphate 
Chemical formula K 2HPO 4 Molecular weight 174,18 
Assay Content not less than 98 % after drying at 105°C for 
four hours 
P2O5 content between 40,3 % and 41,5 % on the 
anhydrous basis 
Description  Colourless or white granul ar powder, crystals or 
masses; deliquescent 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) 
Water-insoluble substances 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 3PO 4 
Hydrated: K 3PO 4 · nH 2O (n = 1 or 3) Molecular weight 212,27 (anhydrous) 
Assay Content not less than 97 % calculated on the ignited 
basis 
P2O5 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 substances 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 
Chemical name Calcium dihydrogen phosphate Chemical formula Anhydrous: Ca(H 2PO 4)2 
Monohydrate: Ca(H 2PO 4)2 · H 2O 
Molecular weight 234,05 (anhydrous) 
252,08 (monohydrate) 
Assay Content not less than  95 % on the dried basis 
P2O5 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)  
Anhydrous: not more than 25,0 % (determined by 
drying at 105 °C for one h our, 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 
Aluminium Not more than 1 mg/kg 
Not more than 70 mg/kg (o nly 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 orthophosphate; Secondary calcium phosphate 
Chemical formula Anhydrous: CaHPO 4 
Dihydrate: CaHPO 4 · 2H 2O 
Molecular weight 136,06 (anhydrous) 
172,09 (dihydrate) 
Assay Dicalcium phosphate, afte r drying at 200 °C for three 
hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO
4 
P2O5 content between 50,0 % and 52,5 % on the 
anhydrous basis 
Description  White crystals or granul es, 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 
Aluminium Not more than 1 mg/kg 
Not more than 100 mg/kg fo r 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 fo r 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 fo r 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, tribas ic; Calcium orthophosphate; 
Pentacalcium hydroxy monophosphate; Calcium hydroxyapatite 
Definition  Tricalcium phosphate consists  of a variable mixture of 
calcium phosphates obtained  from neutralisation of 
phosphoric acid with calciu m hydroxide and having 
the approximate composition of 10CaO· ·3P 2O5  ·H 2O 
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 
P2O5 content between 38,5 % and 48,0 % on the 
anhydrous basis 
Description  A white, odourless powder which is stable in air 
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 hours 
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 
Aluminium Not more than 1 mg/kg 
Not more than 150 mg/kg (o nly 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 2PO 4)2 nH 2O (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 (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 343(ii) DIMAGNESIUM PHOSPHATE 
Synonyms   Magnesiumhydrogenphosphate; 
Magnesiumphosphate, dibasic; Dimagnesium orthophosphate; Secondary magnesiumphosphate  
Definition   
EINECS 231-823-5  
Chemical name  Dimagnesiummonohydrogenmonophosphate  
Chemical formula  MgHPO 4 · nH 2O (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 4H4Na2O5 ½ H 2O 
Trihydrate: C 4H4Na2O5 3H 2O  
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  
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 2CO 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 4H5NaO 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, 3h)  
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 4H4K2O5  
Molecular weight  210,27  
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 2CO 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 4H5CaO 5  
Molecular weight  172,14  
Assay  Content not less than 97,5 % on the anhydrous basis  
Description  White powder  
Identification   
Test for malate, 1,2-
dicarboxylic acid and for calcium  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  
 
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 4H5O5)2Ca  
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 4H6O6 
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 c oncentrated 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 
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 -dihydroxybutanedio ate di-hydrate 
Chemical formula C 4H4CaO 6 · 2H 2O 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]20D + 7,0° to + 7,4° (0,1 % in a 1N de HCl solution) 
pH  Between 6,0 and 9,0 (5 % slurry) 
Purity  
Sulphates  Not more than 1 g/kg (as H 2SO 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 6H10O4  
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  
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 6H8Na2O4 
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 °C - 152 °C (for adipic acid) 
Solubility Approximately 50 g/100 ml water (20 °C) 
Test for sodium 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 
 
E 357 POTASSIUM ADIPATE 
Synonyms   
Definition   
EINECS 242-838-1 
Chemical  name Potassium adipate 
Chemical formula C 6H8K2O4 
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 °C - 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 
 
E 363 SUCCINIC ACID 
Synonyms   
Definition   
EINECS 203-740-4  Chemical name  Butanedioic acid  
Chemical formula  C 4H6O4  
Molecular weight  118,09  
Assay  Content no less than 99,0 %  
Description  Colourless or white, odourless crystals  
Identification   
Melting range  185,0 °C - 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 6H17N3O7  
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  
 
E 385 CALCIUM DISODIUM ETH YLENEDIAMINETETRAACETATE 
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 ′,ON,ON]calciate(2)-disodium; 
Calcium disodium ethylenediaminetetra acetate; Calcium disodium (ethylenedinitrilo)tetra acetate 
Chemical formula C 10H12O8CaN 2Na2·2H 2O 
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 antio xidant 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
20H28O4) and Carnosol (C 20H26O4) 
(which comprise not less than 90% of the total phenolic diterpenes) 
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 dr ied 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 carno sic 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 extrac tion 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 carno sic 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 ca rbon and/or molecular 
distillation. The extracts may be suspended in 
suitable and approved ca rriers 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 carno sic 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 deod orised, 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 tr eatment with active carbon 
and/or molecular distillati on. 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 carno sic 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 extrac ted by the use of dilute 
alkali from strains of various species of brown seaweeds ( Phaeophyceae )  
EINECS  232-680-1  
Chemical name  
Chemical formula  (C 6H8O6)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 6H8O6)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  
Identification   
Solubility  Insoluble in wate r 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 distinguishes 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 p ectin, 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)  Not more than 2 % on th e anhydrous basis insoluble 
matter  
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 6H7NaO 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 90,8 % a nd not more than 106,0 % of 
sodium alginate (calculate d 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 6H7KO 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 
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 6H11NO 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 (calcu lated 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  
 E 404 CALCIUM ALGINATE 
Synonyms   Calcium salt of alginate  
Definition   
EINECS  
Chemical name  Calcium salt of alginic acid  
Chemical formula  (C 6H7Ca1/2O6)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 (calculate d 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  Propane-1,2-diol 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 9H14O7)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 CO 2 of carbon dioxide  
Description   Nearly odourless, white to yellowish brown fibrous or 
granular powder  
Identification   
Test for 1,2-propanediol  Pa sses 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 alternatively linked alpha -1,3 and beta-1,4 in the 
copolymer. On about every tenth D-galactopyranose unit one of the hydroxyl gr oups 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 Gracilriaceae  red algae of the class 
Rhodophyceae  
EINECS  232-658-1  
Chemical name   
Chemical formula   
Molecular weight   
Assay  The threshold gel concen tration 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, agglutinated strips, or in cut, flaked or granulated forms.  It may be light yellowish-
orange, yellowish-grey to pa le 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 mo re transparent than in 
water, more or less granul ar, striated, angular and 
occasionally contains frustules of diatoms. Gel strength may be standard ised by the addition of 
dextrose and maltodextrines or sucrose  
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 approximately 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 th e 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 abou t 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 trinitrophenol 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 5g  
Salmonella spp.   Absent in 5g  
 
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); Ca rrageenan (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 Rhodophyceae  
(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. 
The prevalent polysaccharid es in carrageenan are 
designated as kappa, iota, lambda depending on the number of sulphate by re peating unit (i.e. 1,2,3 
sulphate). Between kappa and iota there is a continuum of intermediate compositions differing in number of sulphates per repe at units between 1 and 2. 
During the process, no organic precipitant shall be 
used other than methanol, ethanol and propane-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, propane-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 
% hydrochloric acid)  
Acid-insoluble matter  Not more than 2 % on the dried basis (insoluble in 1 
% v/v sulphuric acid)  
Low molecular weight carrageenan (Molecular 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  
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 E UCHEUMA 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 Rhodophyceae  (red seaweeds) 
followed by fresh water washi ng to remove impurities 
and drying to obtain the pro duct. Further purification 
may be achieved by washing with an alcohol. The alcohols authorised are restri cted to methanol, ethanol 
or propane-2-ol. The product consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose polysaccharide. Up to 15 % algal cellulose is also present in the product. The wordingprocessed eucheuma seaweed is reserved to the non  hydrolysed 
or otherwise chemically degraded Formaldehyde 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, propane-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 
% hydrochloric 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 (Molecular 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  
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  stra ins of carob tree, Cerationia siliqua  
(L.) Taub. (family Leguminosae ). 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  
EINECS  232-541-5  
Chemical name   
Chemical formula   
Molecular weight  50 000 - 3 000 000  
Assay  Galactomannan cont ent 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 a nd 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 in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown  
Solubility  Soluble in hot wa ter, 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 th e 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  
Cadmium  Not more than 1 mg/kg  
Ethanol and propane-2-ol  Not more th an 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 Leguminosae ). 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 cont ent 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 th e 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 mo re 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 othe r Asiatic species of Astragalus  
(family Leguminosae ). It consists mainly of high 
molecular weight polysaccharides (galactoarabans and acidic polysaccharides) whic h, 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  
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 mucilaginous 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 swe ll 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 polysacch arides 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   
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, gr anules, 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 2O 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 carbohy drate with strains of 
Xanthomonas campestris , purified by recovery with 
ethanol or propane-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuron ic acid and pyruvic acid, 
and is prepared as the so dium, 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  
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)  
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 gr inding 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 principa l component consists of a linear chain of (1-4)- β-D-mannopyranose units with 
α-D-galactopyranose units atta ched 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  
 
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 isopropyl alcohol or ethanol, dried, and milled. The high molecular weight polysaccharide 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-
glycosidically 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 %  
Propane-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 6H14O6 
Molecular weight 182,2 
Assay  Content not less than 97 % of total glycitols and not less than 91 % of D-sorb itol on dry weight basis 
(glycitols are compounds w ith the structural formula 
CH
2OH-(CHOH) n-CH 2OH, where “ n” is an 
integer). 
Description White hygroscopic powder, crystalline powder, flakes or granules.  
Appearance of a solution: The solution is clear . 
Identification   
Solubility Very soluble in wate r, 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 bo iling 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 
Purity   
Water content Not more than 1,5 % (Karl Fischer method) 
Sulphated ash Not more than 0,1 % expressed on dry weight basis 
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 
Chlorides Not more than 50 mg/kg expressed on dry weight 
basis 
Sulphates Not more than 100 mg /kg expressed on dry weight 
basis 
Nickel Not more than 2 mg/kg expressed on dry weight 
basis 
Arsenic Not more than 3 mg/k g expressed on dry weight 
basis 
Lead Not more than 1 mg/kg expressed on dry weight 
basis 
 
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 hydr ogenated 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 2OH-
(CHOH) n-CH 2OH, 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 
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 bo iling 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 
Purity   
Water content Not more than 31 % (Karl Fischer method) 
Sulphated ash Not more than 0,1 % (on dry weight basis) 
Reducing sugars Not more than 0,3 % (expressed as glucose on dry 
weight basis) 
Chlorides Not more than 50 mg/kg (on dry weight basis) 
Sulphates Not more than 100 mg/kg (on dry weight basis) 
Nickel Not more than 2 mg /kg (on dry weight basis) 
Arsenic Not more than 3 mg/kg on dry weight basis 
Lead Not more than 1 mg/kg (on dry weight basis) 
 
E 421 — MANNITOL 
(I)MANNITOL  Synonyms D-mannitol 
Definition The part of the product which is not mannitol is 
mainly composed of sorbitol, maltitol and isomalt. 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 (1-0-alpha-D-Glucopyranosyl-D-mannitol dehydrate): 2 % max and 1,6 GPS (6-0-alpha -D-Glucopyranosyl-D-
Sorbitol): 2 % max). Unspecified impurities shall not represent more than 0.1 % of each.  
Manufactured by catalytic hydrogenation of 
carbohydrate solutions containing glucose and/or fructose 
EINECS 200-711-8 
Chemical name D-mannitol 
Chemical formula C 6H14O6 
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 
Infra Red Absorption Spectrometry  Comparison with a reference standard e.g. EP or 
USP 
Specific rotation [ α] 20
D: + 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 
Purity  
Water content  Not more than 0,5 % (Karl Fischer method) 
Reducing sugars Not more than 0,3 % (as glucose) 
Total sugars Not more than 1 % (expressed as glucose) Sulphated ash Not more than 0,1 % 
Chlorides Not more than 70 mg/kg 
Sulphate Not more than 100 mg/kg 
Nickel Not more than 2 mg/kg 
Lead Not more than 1 mg/kg 
(II)MANNITOL MANUFACTURED BY FERMENTATION  
Synonyms D-mannitol 
Definition Manufactured by discontinuous fermentation under 
aerobic conditions using a conventional strain of the 
yeast Zygosaccharomyces 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 6H14O6 
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 
Infra Red Absorption Spectrometry  Comparison with a reference standard e.g. EP or 
USP 
Specific rotation [ α] 20
D: + 23° to + 25° (borate solution) 
pH Between 5 and 8 
Add 0,5 ml of a saturate d solution of potassium 
chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH 
Purity  Arabitol Not more than 0,3 % 
Water content  Not more than 0,5 % (Karl Fischer method) 
Reducing sugars Not more than 0,3 % (expressed as glucose) 
Total sugars Not more than 1 % (as glucose) 
Sulphated ash Not more than 0,1 % 
Chlorides Not more than 70 mg/kg 
Sulphate Not more than 100 mg/kg 
Lead Not more than 1 mg/kg 
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-propanetrio l; Glycerol; Trihydroxypropane  
Chemical formula  C 3H8O3  
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 charac teristic 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 (25/25 °C)  Not less than 1,257  
Refractive index [n]D20  Between 1,471 and 1,474  
Purity  
Water  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  
 
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 grou p per 9 to 19 sugar units 
EINECS   
Chemical name  
Chemical formula   
Molecular weight The main componen t, 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 % so lution 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-1s-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) KONJ AC GLUCOMANNAN 
Synonyms  
Definition  Konjac glucomannan is a water-soluble 
hydrocolloid obtained fr om 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 bran ch at about each 50th or 
60th unit. About each 19th sugar residue is acetylated 
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 % so lution 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-1s-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 
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 th an 3000 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 isopropanol. 
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° in a 400 ml 
beaker. Stir until the mixture is dissolved and continue stirring for an extra 30 min after dissolution (maintain th e temperature above 60°
 C 
during the stirring proces s). Discontinue stirring 
and allow the mixture to co ol at room temperature 
for at least 2 h. 
A firm, viscoelastic gel forms after the temperature 
drops below 40°, 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 D 
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 Isopropyl alcohol 
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 25g 
Escherichia coli Absent in 1 g 
 
E 431 POLYOXYETHYLENE (40) STEARATE 
Synonyms   Polyoxyl (40) stearate; polyoxyethylene (40) 
monostearate  
Definition   A mixture of the mono- a nd 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 °C - 44 °C  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a 
polyoxyethylated polyol 
Purity   
Water  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  
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 (POLYSORBATE 20) 
Synonyms   Polysorbate 20; Polyoxyethylene (20) sorbitan 
monolaurate  Definition   A mixture of the partial esters of sorbitol and its 
mono- and dianhydrides 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 characteristic 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  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 (POLYSORBATE 80) 
Synonyms   Polysorbate 80; Polyoxyethylene (20) sorbitan 
monooleate  
Definition   A mixture of the partial esters of sorbitol and its 
mono- and dianhydrides with edible commercial oleic 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 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 characteristic 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  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 (POLYSORBATE 
40) 
Synonyms   Polysorbate 40; Polyoxyethylene (20) sorbitan 
monopalmitate   
Definition   A mixture of the partial esters of sorbitol and its 
mono- and dianhydrides 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 mon opalmitate 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  
Infrared absorption spectrum  Characteristic of a partial fatty acid ester of a 
polyoxyethylated polyol  Purity   
Water  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 (POLYSORBATE 
60) 
Synonyms   Polysorbate 60; Polyoxyethylene (20) sorbitan 
monostearate  
Definition   A mixture of the partial esters of sorbitol and its 
mono- and dianhydrides 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  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  
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 (POLYSORBATE 65) 
Synonyms   Polysorbate 65; Polyoxyethylene (20) sorbitan 
tristearate  
Definition   A mixture of the partial esters of sorbitol and its 
mono- and dianhydrides 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  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  
 E 440 (i) PECTIN  
Synonyms  
Definition   Pectin consists mainly of the partial methyl esters of 
polygalacturonic 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, etha nol and propane-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 
propane-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 und er alkaline conditions. 
No organic precipitant sh all be used other than 
methanol, ethanol and propane-2-ol  
EINECS   
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 gr eyish 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 th an 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 
propane-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 ph osphatidic acid, mixed 
ammonium salts of phos horylated glycerides  
Definition   A mixture of the ammo nium compounds of 
phosphatidic acids derived fr om 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)  
Description  Unctuous semi-solid to oily solid Identification   
Solubility  Soluble in fats. Inso luble in water. Partially soluble 
in ethanol and in acetone  
Test for glycerol  Passes test 
Test fatty acids  Passes test 
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 di acetate hexaisobutyrate  
Chemical formula  C 40H62O19  
Molecular weight  832-856 (approximate), C 40H62O19: 846,9  
Assay  Content not less than  98,8 % and not more than 
101,9 % of C 40H62O19  
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]40
D: 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 rosi n. 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, an d exudate of living pine 
trees, and substances derived from tall oil rosin, a by-product of kraft (pape r) 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
20H30O2, 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 %, boilding 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-containin g 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 pyrophosphate; Sodium acid pyrophosphate; Disodium pyrophosphate 
Definition   EINECS 231-835-0 
Chemical name Disodium dihydrogen diphosphate 
Chemical formula Na 2H2P2O7 
Molecular weight 221,94 
Assay Content not less than 95 % of disodium diphosphate 
P2O5 content not less than 63,0 % and not more than 
64,5 % 
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  Ttrisodium pyrophosphate; Trisodium 
monohydrogen diphosphate, Trisodium 
monohydrogen pyrophosphate, Trisodium 
diphosphate 
Definition   
EINECS 238-735-6 Chemical name  
Chemical formula Monohydrate: Na 3HP 2O7 · H 2O 
Anhydrous: Na 3HP 2O7 
Molecular weight Monohydrate: 261,95 
Anhydrous: 243,93 
Assay Content not less than  95 % on the dried basis 
P2O5 content not less than 57 % and not more than 
59 % 
Description  White powder or grains, o ccurs 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 oC). 
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  
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 4P2O7 
Decahydrate: Na 4P2O7 · 10H 2O 
Molecular weight Anhydrous: 265,94 
Decahydrate: 446,09 
Assay Content not less than 95 % of Na 4P2O7 on the 
ignited basis 
P2O5 content not less than 52,5 % and not more than 
54,0 % 
Description  Colourless or white crystals, or a white crystalline 
or granular powder. Th e 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 
Chemical formula K 4P2O7 
Molecular weight 330,34 (anhydrous) 
Assay Content not less than 95 % (800°C for 0,5 hours)  
P2O5 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 substances 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 2P2O7 
Molecular weight 254,12 
Assay Content not less than 96 % 
P2O5 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) 
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 pyrophosphate Definition   
EINECS 238-933-2 
Chemical name Calcium dihydrogen diphosphate 
Chemical formula CaH 2P2O7 
Molecular weight 215,97 
Assay Content not less than 90 % on the anhydrous basis 
P2O5 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. 
 
E 451 (i) PENTASODIUM TRIPHOSPHATE 
Synonyms  Pentasodium tripolyphosphate; Sodium 
tripolyphosphate 
Definition   
EINECS 231-838-7 
Chemical name Pentasodium triphosphate Chemical formula Na 5O10P3 · nH 2O (n = 0 or 6) 
Molecular weight 367,86 
Assay Content not less than 85,0 % (anhydrous) or 65,0 % 
(hexahydrate) 
P2O5 content not less than 56 % and not more than 
59 % (anhydrous) or not less than 43 % and not 
more than 45 % (hexahydrate) 
Description  White, slightly hygrosco pic 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 substances 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 5O10P3 
Molecular weight 448,42 
Assay Content not less than 85 % on the anhydrous basis 
P2O5 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 
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 
polyphosphates composed of linear chains of metaphosphate units, (NaPO
3)x where x ≥ 2, 
terminated by Na 2PO 4 groups. These substances are 
usually identified by their Na 2O/P 2O5 ratio or their 
P2O5 content. The Na 2O/P 2O5 ratios vary from about 
1,3 for sodium tetrapolyphosphate, 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 polyphosphates, 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 mixt ures of sodium salts of linear 
condensed polyphosphoric acids of general formula H
(n + 2)PnO(3n + 1)  where “n” is not less than 2 
Molecular weight (102) n 
Assay P 2O5 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 metaphos phate; Maddrell's salt; 
Insoluble sodium polyphosphate, IMP 
Definition  Insoluble sodium metaphos phate 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
2O/P 2O5 ratio is about 1,0. The pH of 1 in 3 
suspension in water is about 6,5 
EINECS 272-808-3 
Chemical name Sodium polyphosphate 
Chemical formula Heterogenous mixt ures of sodium salts of linear 
condensed polyphosphoric acids of general formula H
(n + 2)PnO(3n + 1)  where «n» is not less than 2 
Molecular weight (102) n 
Assay P 2O5 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 polyphosphoric acids of general formula H
(n + 2)PnO(3n + 1) where «n» is not less than 2 
Molecular weight (118) n 
Assay P 2O5 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 2O5 content 
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 2O5 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 2O6)n Heterogenous mixtures of calcium salts of 
condensed polyphosphoric acids of general formula H
(n + 2)PnO(n + 1) where «n» is not less than 2 
Molecular weight (198) n 
Assay P 2O5 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 solu ble in water. Soluble in acid 
medium 
Test for calcium  Passes test 
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 2O5 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 manufactured 
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 6H10O5)7  
Molecular weight  1 135  
Assay  Content not le ss than 98,0 % of (C 6H10O5)7 on an 
anhydrous basis  
Description  
Appearance of aqueous solution Virtually odourless white or almost white crystalline 
solid  
Clear and colourless 
Identification   
Solubility  Sparingly soluble in water; freely soluble in hot 
water; slightly soluble in ethanol  
Specific rotation 
pH value:   [α]25
D: + 160o to + 164o (1 % solution)  
5,0-8,0 (1 % solution)  
Purity  
Water  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  
 
E 460 (i) MICROCRYSTALLINE CELLULOSE 
Synonyms   Cellulose gel  
Definition   Microcrystalline cellulose is purified, partally 
depolymerised cellulose pr epared 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  
Chemical name  Cellulose  
Chemical formula   (C 6H10O5)n  
Molecular weight  About 36 000  
Assay  Not less than 97 % cal culated 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 pyrocatechol in phosphoric acid and heat for 30 minutes. A red colour is produced  
IR 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 ai r 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 su pernatant 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 th an 0,5 %  (800 ± 25 °C)  
Starch  Not detectable To 20 ml of the disp ersion 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 celluslose 
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 6H10O5)n  
Molecular weight  (162) n (n is predominantly 1 000 and greater)  
Assay  Content not less than 92 %  
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 ai r 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 su pernatant 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 disp ersion 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: 
C6H7O2(OR 1)(OR 2)(OR 3) where R 1, R2, R 3 
each may be one of the following: 
– H 
– CH 3 or – CH 2CH 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 2CH 2OH)  
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: 
C6H7O2(OR 1)(OR 2) where R 1 and R 2 may 
be any of the following: 
– H 
– CH 2CH 3  
Molecular weight   
Assay Content not less than 44 % and not more than 50 % 
of ethoxyl groups (-OC 2H5) 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 solv ents depending upon the 
ethoxyl content. Ethyl cellu lose containing less than 
46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydroc arbon 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 
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 wi th hydroxypropyl groups  
EINECS  
Chemical name  Hydroxypropyl ether of cellulose  
Chemical formula  The polymers contain substituted anhydroglucose 
units with the following general formula: 
C6H7O2(OR 1)(OR 2)(OR 3), where R 1, R2, R3 
each may be one of the following: 
- H - CH
2CHOHCH 3 
- 
CH 2CHO(CH 2CHOHCH 3)CH 3 
- 
CH 2CHO[CH 2CHO(CH 2CHO
HCH 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 2CHOHCH 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  
 
E 464 HYDROXYPROPYL METHYL CELLULOSE 
Synonyms  
Definition   Hydroxypropyl methyl cellulose is cellulose obtained 
directly from  strains of fibrous plant material and partially etherified wi th 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: 
C6H7O2(OR 1)(OR 2)(OR 3), where R 1, R 2 R3 
each may be one of the following: 
– - H 
– - CH 3 
– - CH 2CHOHCH 3 
– - CH 2CHO 
(CH 2CHOHCH 3) CH 3 – - CH 2CHO[CH 2CHO 
(CH 2CHOHCH 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
2CHOHCH 3), on the anhydrous basis  
Description   Slightly hygroscopic white or slightly yellowish or 
greyish odourless and tastel ess, 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 pl ant material and partially 
etherified with methyl and ethyl groups  
EINECS  
Chemical name  Ethyl methyl ether of cellulose  
Chemical formula  The polymers contain substituted anhydroglucose 
units with the following general formula: 
C6H7O2(OR 1)(OR 2)(OR 3), where R 1, R2 R3 each may 
be one of the following: 
– H 
– CH 3 
– CH 2CH 3  
Molecular weight  From about 30 000 to 40 000  
Assay  Content on the anhydr ous 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 2CH 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 tastel ess, 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  
 
E 466 SODIUM CARBOXY METHYL C ELLULOSE, CARBOXY METHYL 
CELLULOSE, CELLULOSE GUM 
Synonyms   CMC; NaCMC; Sodium CMC;  
Definition  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  
EINECS  
Chemical name  Sodium salt of the carboxymethyl ether of cellulose  
Chemical formula  The polymers contain substituted anhydroglucose 
units with the following general formula: 
C6H7O2(OR 1)(OR 2)(OR 3), where R 1, R2 R3 each may 
be one of the following: 
– H 
– CH 2COONa 
– CH 2COOH  
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  
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 car boxymethyl 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 car boxymethyl 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 2COOH) 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 CAR BOXYMETHYLCELLULOSE, CROSS-
LINKED CELLULOSE GUM 
Synonyms   Cross-linked carboxymethyl cellulose; Cross-linked 
CMC; Cross-linked sodium CMC;  
Definition   Cross-linked sodium carboxy methyl cellulose is the 
sodium salt of thermally cross-linked partly O-carboxymethylated cellulose  EINECS  
Chemical name  Sodium salt of th e cross-linked carboxymethyl ether 
cellulose  
Chemical formula  The polymers co ntaining substituted anhydroglucose 
units with the general formula: 
C6H7O2(OR 1)(OR 2)(OR 3) 
where R 1, R2 and R 3 may be any of the following: 
– H 
– CH 2COONa 
– CH 2COOH  
Molecular weight   
Assay   
Description  Slightly hygroscopic, wh ite 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 so lution 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 oC, 3 hours)  
Water solubles  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  CARBOXYMETHYLCELLULOSE, 
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: 
[C6H7O2(OH) x(OCH 2COONa) 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  
Description   White or slightly yellowish or greyish, odourless, slightly hygroscopic 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 intr oduce 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-1s-1 at 25 °C corresponding to 
an average molecule weight of 5 000 D  
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 CALC IUM 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  
Identification   
Solubility  Sodium and potassi um 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 
Na2O  
Potassium  Not less than 13 % and not more than 21,5 % expressed 
as K 2O  
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 anhydr ous 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  
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 monooleate, 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 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 polyglycerols 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 so dium, potassium and calcium salts of fatty 
acids, however these substances may be pres ent up to a maximum level of 6 % (expressed 
as sodium oleate)  
 
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 acet ic 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 so dium, potassium and calcium salts of fatty 
acids, however these substances may be pres ent up to a maximum level of 6 % (expressed 
as sodium oleate)  
 
E 472 b LACTIC ACID ESTERS OF MO NO- AND DIGLYCERIDES OF FATTY 
ACIDS 
Synonyms   Lactic acid esters of mono- and diglycerides; 
Lactoglycerides; Mono- and di glycerides 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, fr ee fatty acids, free lactic 
acid and free glycerides  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 wa ter 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 so dium, potassium and calcium salts of fatty 
acids, however these substances may be pres ent up to a maximum level of 6 % (expressed 
as sodium oleate)  
 
E 472 c CITRIC ACID ESTERS OF MO NO- AND DIGLYCERIDES OF FATTY 
ACIDS 
Synonyms   Citrem; Citric acid esters of mono- and diglycerides; 
Citroglycerides; Mono- and di glycerides 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, fr ee 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 
Test for fatty acids Passes test 
Test for citric acid  Passes test 
Solubility  Insoluble in cold wa ter, dispersible in hot water, 
soluble in oils and fats, in soluble 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 produ cts: 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 so dium, potassium and calcium salts of fatty 
acids, however, these substances may be pres ent up to a maximum level of 6 % (expressed 
as sodium oleate)   
E 472 d TARTARIC ACID ESTERS OF  MONO- AND DIGLYCE RIDES OF FATTY 
ACIDS  
Synonyms   Tartaric acid esters of m ono- 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 liqui ds 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  
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 so dium, potassium and calcium salts of fatty 
acids, however these substances may be pres ent up to a maximum level of 6 % (expressed 
as sodium oleate)  
 
E 472 e MONO- AND DIACETYLTARTARI C 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 aci d; Diacetyltartaric and 
fatty acid esters of glycerol  
Definition   Mixted esters of glycerol with mono- and 
diacetyltartaric acids (obtaine d 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 acid s 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  
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 so dium, potassium and calcium salts of fatty 
acids, however these substances may be pres ent up to a maximum level of 6 % (expressed 
as sodium oleate)  
 
E 472 f MIXED ACETIC AND TARTARIC ACID ES TERS OF MONO- AND 
DIGLYCERIDES OF FATTY ACIDS 
Synonyms   Mono- and diglycerides of fa tty acids esterified with 
acetic acid and tartaric acid  
Definition   Esters of glycerol with a cetic 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 ecetic acids, and free glycerides. May contain mono- and diacetyltart aric 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  
Purity criteria apply to the additive free of so dium, potassium and calcium salts of fatty 
acids, however these substances may be pres ent 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- an d 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 (i ncluding lauric acid) or by 
extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propane-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  
⎪⎭⎪⎬⎫
glycol Prolyleneol-2- Propaneacetate Ethyl
 
 Not more than 350 mg/kg, singly or in combination 
Methyl ethyl ketone  Not more than 10 mg/kg  
Purity criteria apply to the additive free of so dium, potassium and calcium salts of fatty 
acids, however these substances may be pres ent 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) togeth er with residual mono-, di- 
and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propane-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  
⎭⎬⎫
 e Cyclohexanpropanol-1- methyl-2
  
Not more than 10 mg/kg, single or in combination  
⎭⎬⎫
 ol-2- Propane acetate Ethyl
  
Not more than 350 mg/kg, single or in combination  
Purity criteria apply to the additive free of so dium, potassium and calcium salts of fatty 
acids, however these substances may be pres ent up to a maximum level of 6 % (expressed 
as sodium oleate)  
 
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 polyglycerols 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 so dium, potassium and calcium salts of fatty 
acids, however these substances may be pres ent 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  
Definition   Polyglycerol polyricinoleate is prepared by the 
esterification of polyglycerol  with condensed castor oil 
fatty acids  
EINECS  
Chemical name   
Chemical formula   
Molecular weight   
Assay   
Description  Clear, highly viscous liquid  
Identification   
Solubility  Insoluble in water a nd 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]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 
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 th an 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 so dium, potassium and calcium salts of fatty 
acids, however these substances may be pres ent 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 desodorisation 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  
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 am ounts of sodium salts of 
other related acids, manufact ured 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 21H39O4Na ; C 19H35O4Na  (major components) 
Molecular weight   
Assay   
Description  White or slightly yellowish powder or brittle solid with 
a characteristic 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 am ounts of calcium salts of 
other related acids, manufact ured 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  227-335-7  
Chemical name  Calcium di-2-stearoyl lactate 
Calcium di(2-stearoyloxy)propionate  
Chemical formula  C 42H78O8Ca ; C 38H70O8Ca, C 40H74O8Ca (major 
components) 
Molecular weight   
Assay   Description   White or slightly yellowish powder or brittle solid with 
a characteristic 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 amou nts of monoester and of 
unchanged starting materials  
EINECS  
Chemical name  Distearyl tartrate 
Dipalmityl tartrate  Stearylpalmityl tartrate  Chemical formula  C40H78O6 (Distearyl tartrate) 
C36H70O6 (Dipalmityl tartrate) 
C38H74O6 (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)  
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 temperat ures above its melting point in 
toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insol uble 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  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  
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; dispersi ble 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  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, co mmercial lauric acid  
EINECS  215-663-3  
Chemical name  
Chemical formula   
Molecular weight  
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  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-so rbitan monooleate. Other 
constituents include isosor bide 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 temperat ures above its melting point in 
ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water, dispersible in warm water  
Iodine value  The residue of  oleic acid, obtained from the 
saponification of the sorbitan monoleate in assay, has a iodine value between 80 and 100  
Purity   
Water  Not more than 2 % (Karl Fischer method)  
Sulphated ash  Not more than 0,5 %  
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 temperat ures above its melting point in 
ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ethe r 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  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  
 
E 500(i) SODIUM CARBONATE 
Synonyms   Soda ash  
Definition   
EINECS 207-838-8  
Chemical name  Sodium carbonate  
Chemical formula  Na 2CO 3 · nH 2O (n = 0, 1 or 10)  
Molecular weight  106,00 (anhydrous)  
Assay  Content not less than 99 % of Na 2CO 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 a mmonia detectable after heating  
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 2O  
Molecular weight  226,03  
Assay  Content between 35,0 % and 38,6 % of NaHCO 3 and 
between 46,4 % and 50,0 % of Na 2CO 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 2CO 3 · nH 2O (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  
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 wh ite 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 cons ists of ammonium 
carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions  
EINECS 233-786-0  
Chemical name  Ammonium carbonate  
Chemical formula  CH 6N2O2, CH 8N2O3 and CH 5NO 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  
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 5NO 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 2O 
Assay Not less than 24 % and not more than 26,4 % of Mg 
Description  Odourless, light, white friable masses or as a bulky 
white 
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 3Mg(OH) 2 · 5H 2O 
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  
Chemical formula  HCl  
Molecular weight  36,46  
Assay  Hydrochloric acid is co mmercially available in varying 
concentrations. 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 organi c 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)  
Sodium  Negative test  
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 2O (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 and for 
chloride  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 2O  
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  
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 2O  
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) and for 
chloride  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 2SO 4  
Molecular weight  98,07  
Assay  Sulphuric acid is comm ercially 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  
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 2SO 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 2SO 4 · nH 2O (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 % (decahydrate) at 130 oC  
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  
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  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 2SO 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  
Molecular weight  136,17  
Assay  Content not less than 99 %  
Description  White deliquescent crystals, pieces or granules  
Identification   
A. 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 2O (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  
Chemical formula  (NH 4)2SO 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) 
C. Solubility  Freely soluble in water, insoluble in ethanol  
Purity   
Loss on ignition  Not more th an 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  
Chemical name  Aluminium sodium sulphate  
Chemical formula  AlNa(SO 4)2 · nH 2O (n = 0 or 12)  
Molecular weight  242,09 (anhydrous)  
Assay  Content on the anhydr ous 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 °C - 55 °C, 1 
hour then 200 °C, 16 hours)  
Ammonium salts  No odour of a mmonia 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 2O  
Molecular weight  474,38 
Assay  Content not less than 99,5 %  
Description  Large, transparent crystals or  white crystalline powder  
Identification   
Test for aluminium, for 
potassium and for sulphate 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 a mmonia 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 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 2O  
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. Soluti ons 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  
Identification   
Test for sodium Passes test 
pH  Strongly alkaline (1 % solution) 
Solubility  Very soluble in wa ter. 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 2CO 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 wa ter. Freely soluble in ethanol  
Purity   
Water insoluble matter  A 5 % solution is completely clear and colourless  
Carbonate  Not more than 3,5 % (as K 2CO 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  
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 wa ter. 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 4OH  
Molecular weight  35,05  
Assay  Content not less than 27 % of NH 3  
Description  Clear, colourless solution, having an exceedingly 
pungent, characteristic 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  Identification   
Test for magnesium  Passes test 
Test for alkali  Passes test 
Solubility  Practically insolu ble 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 generate d on moistening the sample with water Solubility  Slightly soluble in wa ter. 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  
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 dens e, 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 vo lume 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 4Fe(CN) 6 · 10 H 2O  
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  
Chemical name  Potassium ferrocyanide  
Chemical formula  K 4Fe(CN) 6 · 3 H 2O  
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 2Fe(CN) 6 · 12H 2O  
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  
Chemical name  Sodium trialumini um tetradecahydrogen octaphosphate 
tetrahydrate (A); Tr isodium dialuminium 
pentadecahydrogen octaphosphate (B)  Chemical formula  NaAl 3H14(PO 4)8 · 4H 2O (A) 
Na3Al2H15(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 °C - 800 °C, 2 hours) 
15 % - 16 % (B) (750 °C - 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, yieldi ng 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  Possitive 
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) 
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 % afte r drying (1 000 °C, hydrated 
forms)  
Soluble ionisable salts  Not more than 5,0 % (as Na 2SO 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 
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 sy nthetic compound of which 
the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5  
EINECS  
Chemical name   
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 2Si3O8 · nH 2O (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 % a nd 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  
 
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(Si4O10)(OH) 2 
Molecular weight 379,22 
Assay   
Description  Light, homogeneous, white or almost white powder, 
greasy to the touch 
Identification   
IR absorption 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 2O3 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) 
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, constant weight) 
Sodium Not less than 5 % and not more than 8,5 % (as Na 2O) 
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 (muscovite) 
EINECS 310-127-6 
Chemical name Potassium aluminium silicate 
Chemical formula KAl 2[AlSi 3O10](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, di luted 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 
 
E 556 CALCIUM ALUMINIUM SILICATE 
Synonyms  Calcium aluminosilicate; calcium silicoaluminate; 
aluminium calcium silicate 
Definition   
EINECS  
Chemical name Calcium aluminium silicate 
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 2O3 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 
 
E 559 ALUMINIUM SILICATE (KAOLIN) 
Synonyms  Kaolin, light or heavy 
Definition  Aluminium silicate hydrous (k aolin) 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 al uminium 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 2Si2O5(OH) 4 (kaolinite) 
Molecular weight 264 
Content not less than 90 % (sum of silica and alumina, 
after ignition) 
Silica (SiO 2) Between 45 % 
and 55 % Assay 
Alumina (Al 2O3) 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 
IR absorption: Peaks at 3 700 and 3 620 cm-1 
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 2O) 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), 
laurinc acid (C 12), myristic acid (C 14), palmitic acid 
(C16), stearic acid (C 18), oleic acid (C 18:1)  
EINECS  
Chemical name  octanoic acid (C 8); decanoic acid (C 10); dodecanoic acid 
(C12); 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   
Individual fatty acids can be 
identified by acid value, iodine value, gas chromatog-raphy 
  
Purity   
Residue on ignition  Not more than 0,1 %  
Unsaponifiable matter  Not more than 1,5 %  
Water  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 aque ous solution of gluconic acid 
and glucono-delta-lactone  
EINECS  
Chemical name  Gluconic acid  
Chemical formula  C 6H12O7 (gluconic acid)  
Molecular weight  196,2  
Assay  Content not less than 49,0 % (as gluconic acid)  
Description  Colourless to light yello w, 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-gluc onic acid delta-lactone; 
delta-gluconolactone  
Definition   Glucono-delta-lactone is the cyclic 1,5-intramolecular 
ester of D-gluconic acid . In aqueous media it is 
hydrolysed to an equilibr ium 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 6H10O6  
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  
B. Solubility  Freely soluble in wa ter. Sparingly soluble in ethanol  
Purity   
Water  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 
EINECS 208-407-7  
Chemical name  Sodium D-gluconate  
Chemical formula  C 6H11NaO 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 6H11KO 7 (anhydrous) 
C6H11KO 7 · H 2O (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  
Chemical formula  C 12H22CaO 14 (anhydrous) 
C12H22CaO 14 · H 2O (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 and for 
gluconate  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-glucona te dihydrate; Iron(II) di-gluconate 
dihydrate  
Chemical formula C 12H22FeO 14·2H 2O  
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  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 th an 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 6H10FeO 6· nH 2O (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. Pr actically 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 12H18O2 
Molecular weight  197,24  
Assay  Not less than 98 % on the dried basis (4 hours at room 
temperature) 
Description  White powder  
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, floccu lent precipitate dissolves 
producing a yellow solution 
Purity   
Melting range 
Acidity  62 to 67 °C 
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 5H9NO 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]D20 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 
 
E 621 MONOSODIUM GLUTAMATE 
Synonyms  Sodium glutamate; MSG 
Definition   
EINECS 205-538-1 
Chemical name Monosodium  L-glutamate monohydrate 
Chemical formula C 5H8NaNO 4 · H 2O 
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]D20 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 Monopotassi um L-glutamate monohydrate 
Chemical formula C 5H8KNO 4 · H 2O 
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 
Specific rotation [ α]D20 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 10H16CaN 2O8 · nH 2O (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]D20 Between + 27,4° and + 29,2° (for calcium diglutamate 
with n = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) 
Purity  
Water Not more than 19,0 % (f or calcium diglutamate with 
n = 4) (Karl Fischer) 
Chloride Not more than 0,2 % 
Pyrrolidone carboxylic Not more than 0,2 % acid 
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 5H12N2O4 · H 2O 
Molecular weight 182,18 
Assay Content not less than 99 ,0 % and not more 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 ammonium Passes test 
Test for glutamic acid (by 
thin-layer chromatography) Passes test 
Specific rotation [ α]D20 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 10H16MgN 2O8 · 4H 2O 
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]D20 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 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  Guanylic acid 
Definition   
EINECS 201-598-8 
Chemical name Guanosine-5'-monophosphoric acid 
Chemical formula C 10H14N5O8P 
Molecular weight 363,22 
Assay Content not less than 97 ,0 % on the anhydrous basis 
Solubility Slightly soluble in wate r, practically insoluble in ethanol 
Description  Odourless, colourless or white crystals or white 
crystalline powder 
Identification   
Test for ribose and for 
organic phosphate 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   
EINECS 221-849-5 
Chemical name Disodium guanosine-5'-monophosphate 
Chemical formula C 10H12N5Na2O8P · nH 2O (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 
 
E 628 DIPOTASSIUM GUANYLATE 
Synonyms  Potassium guanylate; potassium 5'-guanylate 
Definition   EINECS 226-914-1 
Chemical name Dipotassium guanosine-5'-monophosphate 
Chemical formula C 10H12K2N5O8P 
Molecular weight 439,40 
Assay Content not less than 97 ,0 % on the anhydrous basis 
Solubility Freely soluble in water,  practicaly insoluble in ethanol 
Description  Odourless, colourless or white crystals or white 
crystalline powder 
Identification   
Test for ribose, for 
organic phosphate, and for potassium 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 10H12CaN 5O8P · nH 2O 
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 
Purity   
Loss on drying Not more th an 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 10H13N4O8P 
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 10H11N4Na2O8P · H 2O 
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 
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 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 10H11K2N4O8P 
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 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 10H11CaN 4O8P · nH 2O 
Molecular weight 386,19 (anhydrous) 
Assay Content not less than 97 ,0 % on the anhydrous basis 
Solubility Sparingy soluble in water 
Description  Odourless, colourless or white crystals or powder 
Identification   
Test for ribose, and for 
organic phosphate and for calcium 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 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'-ribonucleo tide is essentially a mixture of 
calcium inosine-5'-monophosphate and calcium guanosine-5'-monophosphate 
Chemical formula C 10H11N4CaO 8P · nH 2O 
C10H12N5CaO 8P · nH 2O 
Molecular weight  
Assay Content of both major comp onents 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 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'-ribonucle otide is essentially a mixture of 
disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate 
Chemical formula C 10H11N4O8P · nH 2O  
C10H12N5Na2O8P · nH 2O 
Molecular weight  
Assay Content of both major comp onents 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, sparin gy solyble 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 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 2H5NO 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 Sodium glycinate  
Definition   
EINECS  227-842-3 
Chemical name Sodium glycinate 
Chemical formula C 2H5NO 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 4H6O4 Zn · 2H 2O 
Molecular weight 219,51 
Assay Content not less than 98 % and not more than 102 % of 
C4H6O4 Zn · 2H 2O 
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   
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 
 
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 stablised 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 silic on not less than 37,3 % and not 
more than 38,5 %  
Description   Clear, colourless, viscous liquid  
Identification   
Specific gravity 
(25°/25 °C)  Between 0,964 and 0,977  Refractive index [n]D25  Between 1,400 and 1,405  
Infrared spectrum  The infrared abso rption 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 Dimethylpolysiloxane Reference Standard  
Purity  
Loss on drying  Not more than 0,5 % (150 °C, 4h)  
Viscosity  Not less than 1,00 · 10-4 m2s-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  Specific gravity  About 0,96  
Solubility  Insoluble in water, sp aringly 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 et hanol and boil gently under 
a reflux condenser for 2 h. Remove the condenser and immediately insert a thermometer. Place the flask in water at 80o and allow to cool, swirling the solution continuously. No precipitate is formed before the temperature reaches 65o, 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, so luble 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  
 
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 cereferia   
EINECS 232-399-4  
Chemical name   
Chemical formula   
Molecular weight  
Assay   
Description  Light brown to pale yellow po wder 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  
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, ve ry slightly soluble in ethanol 
Refractive Index n D100 1,434-1,448 
Alternative n D120 1,426-1,440 
Purity  
Molecular weight  Average not less than 500 
Viscosity at 100 °C Not less than 1,1 x 10-5 m2s-1-1at 100 °C 
Alternative: Not less than 0,8 x 10-5 m2s-1-1at 120 °C, if 
solid at 100 °C 
Residue on ignition Not more than 0,1  wt% 
Carbon number at 5 % distillation point Not more than 5 % of mol ecules 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 10nH20n+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: 
C30: 13 – 37 % 
C40: 35 – 70 % 
C50: 9 – 25 % 
C60: 1 – 7 % 
Description  
Identification   
Solubility Insoluble in water; slig htly soluble in ethanol; soluble in 
toluene 
Burning Burns with a bright flame and a paraffin-like 
characteristic smell 
Viscosity Between 5,7 x 10-6 and 6,1 x 10-6 m2s-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 w ith 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  
Molecular weight  
Assay  
Description  Almost white flakes, powd er, 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 at 120 °C Not less than 8,1 · 10-5 m2s-1 
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 3H7NO 2S · HCl · nH 2O (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]20
D: between + 5,0° and + 8,0° or 
[α]25
D: 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  
Chemical formula  CH 4N2O  
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, crys talline 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  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  
Chemical formula  He  
Atomic weight  4  
Assay  Not less than 99 %  
Description   Colourless, odourless, non-flammable gas  
Identification   
Purity   
Water  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  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 2O  
Molecular weight  44  Assay  Not less than 99 %  
Description  Colourless, non-flammable gas, sweetish odour  
Identification   
Purity   
Water  Not more than 0,05 %  
Carbon monoxide  Not more than 30 µl/l  
Nitrogen dioxide and 
nitrogen oxide  Not more than 10 µl/l  
 
E 943a BUTANE 
Synonyms  n-Butane 
Definition   
EINECS  
Chemical name Butane 
Chemical formula CH 3CH 2CH 2CH 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)2CH 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 % 
 
E 944 PROPANE 
Synonyms   
Definition   
EINECS  
Chemical name Propane 
Chemical formula CH 3CH 2CH 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  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 
Assay Content not less than 99,9 % 
Description  Colourless, odourless, highly flammable gas 
Identification   
Purity   
Water 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; potassi um 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-o xathiazin-4(3H)- one-2,2-dioxide 
potassium salt 
Chemical formula C 4H4KNO 4S 
Molecular weight 201,24 
Assay  Content not less than 99 % of C 4H4KNO 4S 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 
Mercury Not more than 1 mg/kg 
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 14H18N2O5 
Molecular weight 294,31 
Assay Not less than 98 % and not more than 102 % of 
C14H18N2O5 on the anhydrous basis 
Description White, odourless, crystalline powder having a sweet taste. Approximately 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]D20: + 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 spectrophotometer, 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 6H13NO 3S 
Molecular weight 179,24 
Assay Cyclohexylsulphamic acid contains not less than 98 % 
and not more than the equivalent of 102 % of C
6H13NO 3S, 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 % soluti on with hydrochloric acid, add 1 ml 
of an approximately molar solution of barium chloride 
in water and filter if any h aze 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/k g (expressed as selenium on dry 
weight basis) 
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 6H12NNaO 3S and the dihydrate form 
C6H12NNaO 3S·2H 2O 
Molecular weight 201,22 calcu lated 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, pr actically 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/k g (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 12H24CaN 2O6S2· 2H 2O 
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 
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/k g (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 hydrogenation  
EINECS  
Chemical name Isomalt is a mixt ure 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 12H24O11 
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 
C12H24O11.2H 2O 
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. 
Description Odourless, white, slightly hygroscopic, crystalline mass.
Identification   
Solubility Soluble in water, very slightly soluble in ethanol. 
HPLC Passes 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 chromatogram obtained with the reference solution. 
Purity   
Water content Not more than 7 % (Karl Fischer Method) 
Sulphated ash Not more than 0,05 % expressed on dry weight basis 
D-Mannitol Not more than 3 % 
D-Sorbitol Not more than 6 % 
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 e xpressed on dry weight basis 
 
E 954 SACCHARIN AND IT S 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 7H5NO 3S 
Molecular weight 183,18 Assay Not less than 99 % and not more than 101 % of 
C7H5NO 3S 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 th an 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-benzosulph imide; sodium salt of 2,3-dihydro-
3-oxobenzisosulphonazole; oxobenzisosulphonazole; 1,2-benzisothiazolin-3-one- 1, 1-dioxide sodium salt 
dihydrate 
Chemical formula C 7H4NNaO 3S·2H 2O 
Molecular weight 241,19 
Assay Not less than 99 % and not more than 101 % of 
C7H4NNaO 3S 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-oxobenzisosulphonazole; 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7) 
EINECS 229-349-9 
Chemical formula C 14H8CaN 2O6S2·3½H 2O 
Molecular weight 467,48 
Assay Not less than 95 % of C 14H8CaN 2O6S2 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 
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-oxobenzisosulphon azole; potassium salt of 
1,2-benzisothiazolin-3-one- 1,1-dioxide monohydrate 
Chemical formula C 7H4KNO 3S·H 2O 
Molecular weight 239,77 
Assay Not less than 99 % and not more than 101 % of 
C7H4KNO 3S 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 solu tions. 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 th an 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 12H19Cl3O8 
Molecular weight 397,64 
Assay Content not less than 98 % and not more than 102 % 
C12H19Cl3O8 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 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] 20D + 84,0° to + 87,5° calcu lated on the anhydrous 
basis (10 % w/v solution) 
Purity  Water 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 aminoacids 
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) 
Arsenic Not more than 3 mg/kg expressed on dry weight basis 
Lead 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 
dihydrochalcone-4 ′-β-neohesperidoside; neohesperidin 
DC 
Definition  Is is obtained by catalytic hydrogenation of 
neohesperidin 
EINECS 243-978-6 
Chemical name 2-O- α-L-rhamnopyranosyl-4 ′-β-D-glucopyranosyl 
hesperetin dihydrochalcone. 
Chemical formula C 28H36O15 
Molecular weight 612,6 
Assay Content not less than  96 % on the dried basis 
Description Off-white, odourless, crys talline powder having a 
characteristic. 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 282 to 283 nm  for a solution of 2 mg in 100 ml maximum 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 invol ving 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 amount s (0.10 to 0.37% w/w).  
Chemical name Stevioside: 13-[(2-O- β-D-glucopyranosyl- β-D-
glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-
glucopyranosyl ester 
Rebaudioside A: 13-[(2-O- β-D-glucopyranosyl-3-O- β-
D-glucopyranosyl- β-D-glucopyranosyl)oxy]kaur-16-en-
18-oic acid, β-D-glucopyranosyl ester 
Chemical formula  Trivial name                      Formula          Conversion 
factor  
Steviol                                 C 20H30O3                 1,00  
Stevioside                            C 38H60O18                       0,40 
Rebaudioside A                    C 44H70O23                       0,33  
Rebaudioside C                    C 44H70O22                        0,34  
Dulcoside A                          C 38H60O17                       0,40  Rubusoside                           C 32H50O13                      0,50  
Steviolbioside                       C 32H50O13              0,50 
Rebaudioside B                    C 38H60O18               0,40  
Rebaudioside D                    C 50H80O28               0,29  
Rebaudioside E                    C 44H70O23                0,33  
Rebaudioside F                     C 43H68O22               0,34 
Molecular weight and CAS Nr. 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, rubu soside 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 ch romatogram obtained by the 
following 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 5000 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-asp artyl-L-phenylalanine methyl 
ester. 
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 C20H30N2O5 
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-phenylalanyl-2-methyl-L- α-aspartic acid 
Chemical formula C 18H23O9N3S 
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] 20D + 14,5° to + 16,5° 
Determine at a concentration of 6,2 g in 100ml formic 
acid (15N) within 30 min of preparation of the solution. 
Divide the calculated speci fic rotation by 0,646 to 
correct for the aspartame content of the salt of 
aspartame-acesulfame 
Purity  
Loss on drying Not more than 0,5 % (105°C, 4 hours) 
5-Benzyl-3,6-dioxo-2-piper-azineacetic acid Not more than 0,5 %  
Lead Not more than 1 mg/kg  
 
E 965 (i) MALTITOL 
Synonyms D-Maltitol; hydrogenated maltose 
Definition  Maltitol is obtained by hydr ogenation 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 12H24O11 
Molecular weight 344,3 
Assay Content not less than 98 % D-maltitol C 12H24O11 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]D20 = + 105,5° to + 108,5° (5 % w/v solution)  
Purity   
Appearance of the 
aqueous solution  The solution is clear and colourless 
Water content Not more than  1 % (Karl Fischer method) 
Sulphated ash Not more than 0,1 % (expressed on an anhydrous  
weight basis) 
Reducing sugars Not more than 0,1 % (expressed as glucose on an 
anhydrous  weight basis) 
Chlorides Not more than 50 mg/kg (expressed on anhydrous 
weight basis) 
Sulphates Not more than 100 mg/kg (expressed on anhydrous 
weight basis) 
Nickel Not more than 2 mg/kg (expressed on anhydrous weight 
basis) 
Arsenic Not more than 3 mg/kg expressed on anhydrous weight 
basis 
Lead Not more than 1 mg/kg (expressed on anhydrous weight 
basis) 
 
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 hydrogenated oligo- a nd polysaccharides. It is 
manufactured by the cataly tic 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 anhydrou s basis and not less than 
50 % of maltitol on the anhydrous basis 
Description Colourless and odourless, clear viscous liquids or white crystalline masses 
Identification   
Solubility Very soluble in wate r, slightly soluble in ethanol 
HPLC passes 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).  
Purity   
Appearance of the 
solution  The solution is clear and colourless 
Water Not more than 31 % (Karl Fischer method) 
Reducing sugars Not more than 0,3 % (expressed as glucose on an 
anhydrous weight basis) 
Sulphated ash Not more than 0,1 % 
Chlorides Not more than 50 mg/kg 
Sulphate Not more than 100 mg/kg Nickel Not more than 2 mg/kg 
Lead Not more than 1 mg/kg 
 
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 12H24O11 
Molecular weight 344,3 
Assay Not less than 95 % on the dry weight basis 
Description Crystalline powderor 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]D20 = + 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 (e xpressed 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 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 5H12O5 
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 
spectrophotometry Comparison with a reference standard e.g. EP or USP.  
Purity  
Water content Not more than  1% (Karl-Fischer method) 
Sulphated ash Not more than 0,1 % expressed on dry weight basis 
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 e xpressed on dry weight basis 
Chlorides Not more than 100 mg/k g expressed on dry weight basis
Sulphates Not more than 200 mg/k g expressed on dry weight basis
 
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 4H10O4 
Molecular weight 122,12 
Assay Not less than 99% after drying 
Description  White, odourless, non-hygrosc opic, heat-stable crystals 
with a sweetness of approx imately 60-80% that of 
sucrose. 
Identification   
Solubility Freely soluble in water, slightly soluble in ethanol, 
insoluble in diethyl ether. 
Melting range 119-123 °C 
Purity   
Loss on drying Not more than 0,2 % (70 °C, 6 hours, in a vacuum 
desiccator) 
Sulphated ash Not more than 0,1 % 
Reducing substances Not more th an 0,3 % expressed as D-glucose Ribitol and glycerol Not more than 0,1 % 
Lead Not more than 0,5 mg/kg 
 
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 consisti ng of glycosides of quillaic 
acid. Some sugars includ ing 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  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  
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 95 0 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 
Lead Not more than 5 mg/kg 
Mercury Not more than 1 mg/kg 
Microbiological criteria   
Total bacterial count Not more than 5 × 104 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. Th e 1,6-glucosidic linkage 
predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucos an (1,6-anhydro-D-glucose) 
and citric acid and may be  neutralised with any food 
grade base and/or decolorised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce 
residual glucose. Polydext rose-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  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  
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 6H9NO) n 
Weight 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 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 
polyvinylpyrrolidone 
Definition  Polyvinylpolypyrrolidone is  a poly-[1-(2-oxo-1-
pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the pol ymerisation of N-vinyl-2-
pyrrolidone in the presence of e ither 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 6H9NO) 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 
pH  Between 5,0 and 8,0 (1 % suspension in water) 
Purity   
Water 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 synthe tic resin prepared by the 
polymerisation of vinyl acetate, followed by partial hydrolysis of the ester in the presence of an alkaline catalyst. The physical characte ristics of the product depend 
on the degree of polymerisation and the degree of hydrolysis. 
Chemical name Ethenol homopolymer 
Chemical formula (C2H3OR) 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 0.25g 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 precipitate. 
Colour reaction Dissolve 0.01g 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 0.5g 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 26000-30000 D 
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 % Metha nol, 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 2.0 mg/kg 
 
E 1204 PULLULAN 
Synonyms   
Definition  Linear, neutral glucan consisting mainly of maltotriose 
units connected by -1,6 glycos idic 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 fermentation, the fungal cells are removed by mi crofiltration, 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 6H10O5)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, pr actically insoluble in ethanol 
pH  5,0 to 7,0 (10 % solution) 
Precipitation with 
polyethylene glycol 600 Add 2 ml of polyethylene glyc ol 600 to 10 ml of a 2 % 
aqueous solution of pullulan. A white precipitate is 
formed 
Depolymerisation with pullulanase Prepare two test tubes each w ith 10 ml of a 10 % pullulan 
solution. Add 0,1 ml pullula nase solution having activity 
10 units/g to one test tube, a nd 0,1 ml water to the other. 
After incubation at about 25 °C for 20 minutes, the viscosity of the pullulanase-t reated solution is visibly 
lower than that of the untreated solution Viscosity 100 to 180 mm2/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 methacrylate, dimethylaminoethyl methacrylate, methyl methacrylate polymer; butyl methacrylate, methyl methac rylate, dimethylaminoethyl 
methacrylate polymer 
Definition   Basic methacrylate copolymer is manufactured by 
thermic controlled polymerisation of the monomers methyl methacrylate, butyl methacrylate and dimethylaminoethyl methacrylate, dissolved in 2-propanol) by using a free ra dical donor ini tiator 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. Th e granules resulting are 
commercialised as such or undergo a second milling step (micronisation). 
Chemical name Poly(butyl methacrylate- co-(2-
dimethylaminoethyl)methacrylate- co-methyl methacrylate) 
1:2:1  
Chemical formula  Poly[(CH2:C(CH3)CO2(CH2)2N(CH3)2)-co-(CH2:C(CH3)CO2CH3)-co-
(CH2:C(CH3)CO2(CH2)3CH3)]
 
Weight Average 
Molecular Weight estimated by Gel Permeation Approximately 47000g/mol Chromatography  
Particle size of powder 
(when used forms a 
film) < 50 µm   more than 50%  
< 0,1 µm  5,1 – 5,5 %   
Assay:  
(Ph. Eur. 2.2.20 "Potentiometric 
titration")  20.8 - 25.5% dimethylaminoethyl (DMAE) groups on dry 
substance 
Description   Granules are colourless to yellow tinged, the powder is 
white  
Identification  
IR spectroscopy To be identified 
Viscosity of a 12,5% solution in 60:40 (w/w/) isopropyl alcohol to acetone 3 – 6 mPa.s  
Refractive index  nD20 1.380 – 1.385 
Solubility  1 gr dissolves in 7 g Methanol, Ethanol, 2-propanol, 
dichloromethane, aqueous Hydrochloric acid 1N. 
Not soluble in petroleum ether. 
Purity  
Loss of drying  Not more than 2.0 % (105°C, 3H) 
Alkali value  162 – 198 mg KOH/ g of Dried Substance 
Sulphated ash  Not more than 0,1 %  
Residual monomers Butylmethacrylate < 1000 mg/kg 
Methyl methacrylate < 1000 mg/kg 
Dimethylaminoethyl methacrylate < 1000 mg/kg 
Solvent residues 2-Propanol < 0.5% 
Butanol      < 0.5% Methanol  < 0.1% 
Arsenic  Not more than 2 mg/kg  
Lead  Not more than 2 mg/kg  
Mercury Not more than 2 mg/kg 
Copper Not more than 10 mg/kg 
 E 1404 OXIDISED STARCH 
Synonyms  
Definition   Oxidised starch is starch treated with sodium hypochlorite 
EINECS  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description   White or nearly white powd er or granules or (if 
pregelatinised) flakes, amorphous powder or coarse particles  
Identification   
Microscopic observation Passes test (if not pregelatinised) 
Iodine staining  Passes test (d ark 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 star ch esterified with ortho-
phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate  
EINECS  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description   White or nearly white powd er or granules or (if 
pregelatinised) flakes, am orphous powder or coarse 
particles  
Identification   
Microscopic observation Passes test (if not pregelatinised) 
Iodine staining  Passes test (d ark 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 1412 DISTARCH PHOSPHATE 
Synonyms  
Definition   Distarch phosphate is starch  cross-linked with sodium 
trimetaphosphate or phosphorus oxychloride  
EINECS  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powd er or granules or (if 
pregelatinised) flakes, am orphous powder or coarse 
particles  
Identification   
Microscopic observation Passes test (if not pregelatinised) 
Iodine staining  Passes test (d ark 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 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 powd er or granules or (if 
pregelatinised) flakes, am orphous powder or coarse 
particles  
Identification   
Microscopic observation Passes test (if not pregelatinised) 
Iodine staining  Passes test (d ark 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 powd er or granules or (if 
pregelatinised) flakes, am orphous powder or coarse 
particles  
Identification   
Microscopic observation Passes test (if not pregelatinised) 
Iodine staining  Passes test (d ark 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)  
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 star ch esterified with acetic 
anhydride or vinyl acetate  
EINECS  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description   White or nearly white powd er or granules or (if 
pregelatinised) flakes, am orphous powder or coarse 
particles  
Identification   
Microscopic observation Passes test (if not pregelatinised) Iodine staining  Passes test (d ark 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  
 
E 1422 ACETYLATED DI STARCH ADIPATE 
Synonyms   
Definition  Acetylated distarch adipate is starch cross-linked with 
adipic anhydride and esterifi ed with acetic anhydride  
EINECS  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powd er or granules or (if 
pregelatinised) flakes, amorphous powder or coarse particles  Identification   
Microscopic observation Passes test (if not pregelatinised) 
Iodine staining  Passes test (d ark 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 powd er or granules or (if 
pregelatinised) flakes, am orphous powder or coarse 
particles  
Identification   
Microscopic observation Passes test (if not pregelatinised) 
Iodine staining  Passes test (d ark 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)  
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 phospha te 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 powd er or granules or (if 
pregelatinised) flakes, am orphous powder or coarse 
particles  
Identification   
Microscopic observation Passes test (if not pregelatinised) 
Iodine staining  Passes test (d ark 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)  
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 
octenylsuccinic anhydride  
EINECS  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description   White or nearly white powd er or granules or (if 
pregelatinised) flakes, am orphous powder or coarse 
particles  
Identification   
Microscopic observation Passes test (if not pregelatinised) 
Iodine staining  Passes test (d ark 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 th an 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 powd er or granules or (if 
pregelatinised) flakes, amorphous powder or coarse particles  
Identification   
Microscopic observation Passes test (if not pregelatinised) 
Iodine staining  Passes test (d ark 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 succ inate is starch esterified 
with octenylsuccinic anhydride and treated with aluminium sulphate 
EINECS  
Chemical name  
Chemical formula  
Molecular weight  
Assay  
Description  White or nearly white powd er or granules or (if 
pregelatinised) flakes, am orphous powder or coarse 
particles 
Identification   
Microscopic observation Passes test (if not pregelatinised) 
Iodine staining  Passes test (d ark blue to light red colour) 
Purity    
Loss on drying  Not more than 21,0 %  
Octenylsuccinyl groups Not more th an 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) 
 
E 1505 TRIETHYL CITRATE  
Synonyms   Ethyl citrate  
Definition   
EINECS 201-070-7  
Chemical name  Triethyl-2-hydr oxypropan-1,2,3-tricarboxylate  
Chemical formula  C 12H20O7  
Molecular weight  276,29  
Assay  Content not less than 99,0 %  
Description  Odourless, practically colourless, oily liquid  
Identification   
Specific gravity  d 2525: 1,135-1,139  
Refractive index  [n] D20: 1,439-1,441  
Purity   
Water  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 pr edominantly 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 7H12O5 
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 d 2020: 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 ascetic acid) 
Arsenic Not more than 3 mg/kg 
Lead Not more than 2 mg/kg 
 
E 1518 GLYCERYL TRIACETATE 
Synonyms   Triacetin 
Definition   
EINECS  203-051-9  
Chemical name  Glyceryl triacetate  
Chemical formula  C 9H14O6  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  Between 1,429 and 1,431 at 25 °C  
Specific gravity 
(25 °C/25 °C) Between 1,154 and 1,158  
Boiling range  Between 258° and 270 °C  
Purity   
Water  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 7H8O 
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] D20: 1,538 - 1,541 
Specific gravity d 2525: 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 bezaldehyde) 
Lead Not more than 2 mg/kg 
 
E 1520 PROPANE-1,2-DIOL 
Synonyms   Propylene glycol  
Definition   
EINECS 200-338-0  
Chemical name 1,2-dihydroxypropane  
Chemical formula  C 3H8O2  
Molecular weight  76,10  
Assay  Content not less than 99,5 % on the anhydrous basis  
Description  Clear, colourless, hygros copic, viscous liquid  
Identification   
Solubility  Soluble in water, ethanol and acetone  
Specific gravity  d 2020: 1,035 - 1,040  
Refractive index   [n]20
D: 1,431 - 1,433  Purity  
Distillation test 99,5% of the pro duct distils between 185 °C - 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  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-omeg a-hydroxypoly (oxy-1,2-ethanediol) 
Chemical formula  (C 2H4O)n H2O (n = number of ethylene oxide units 
corresponding to a molecular weight of 6 000, about 140) 
Average Molecular 
weight  380 to 9000 D  
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 hygroscopic 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  
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 sli ghtly 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