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Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council Text with EEA relevance

Type Regulation
Publication 2012-03-22
Last updated 2026-08-18
State In force
Department European Commission
Source EUR-Lex
articles 4
Reform history JSON API
Synonyms Citrem; Citric acid esters of mono- and diglycerides; Citroglycerides; Mono- and diglycerides of fatty acids esterified with citric acid
Definition Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium, potassium or calcium salts suitable for the purpose and authorised as food additives according to this Regulation.
Einecs
Chemical name
Chemical formula
Molecular weight
Assay
Description Yellowish or light brown liquids to waxy solids or semi-solids
Identification Identification
Test for glycerol Passes test
Test for fatty acids Passes test
Test for citric acid Passes test
Solubility Insoluble in cold water, dispersible in hot water, soluble in oils and fats, insoluble in cold ethanol
Purity Purity
Acids other than citric and fatty acids Less than 1 %
Free glycerol Not more than 2 %
Total glycerol Not less than 8 % and not more than 33 %
Total citric acid Not less than 13 % and not more than 50 %
Sulphated ash Non-neutralised products: not more than 0,5 % (800 ± 25 °C) Partially or wholly neutralised products: not more than 10 % (800 ± 25 °C)
Lead Not more than 2 mg/kg
Acid value Not more than 130

Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Tartaric acid esters of mono- and diglycerides; Mono- and diglycerides of fatty acids esterified with tartaric acid
Definition Esters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides
Einecs
Chemical name
Chemical formula
Molecular weight
Assay
Description Sticky viscous yellowish liquids to hard yellow waxes
Identification Identification
Test for glycerol Passes test
Test for fatty acids Passes test
Test for tartaric acid Passes test
Purity 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 sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Diacetyltartaric acid esters of mono- and diglycerides; Mono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acid; Diacetyltartaric and fatty acid esters of glycerol
Definition Mixed esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids
Einecs
Chemical name
Chemical formula
Molecular weight
Assay
Description Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid
Identification 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 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 sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Mono- and diglycerides of fatty acids esterified with acetic acid and tartaric acid
Definition Esters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids
Einecs
Chemical name
Chemical formula
Molecular weight
Assay
Description Sticky liquids to solids, from white to pale-yellow in colour
Identification 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 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 sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

E 473 SUCROSE ESTERS OF FATTY ACIDS
Synonyms Sucroesters; Sugar esters
Definition Essentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl, ethyl and vinyl esters of food fatty acids (including lauric acid) or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propan-2-ol, 2-methyl-1-propanol, propylene glycol, methyl ethyl ketone and supercritical carbondioxide may be used for their preparation. p-methoxy phenol can be used as a stabiliser during the manufacturing procedure.
Einecs
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 80 %
Description Stiff gels, soft solids or white to slightly greyish-white powders
Identification Identification
Test for sugar Passes test
Test for fatty acids Passes test
Solubility Sparingly soluble in water, soluble in ethanol
Purity Purity
Sulphated ash Not more than 2 % (800 ± 25 °C)
Free sugar Not more than 5 %
Free fatty acids Not more than 3 % estimated as oleic acid
p-methoxy-phenol Not more than 100 μg/kg
Acetaldehyde Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Methanol Not more than 10 mg/kg
Dimethylsulphoxide Not more than 2 mg/kg
Dimethylformamide Not more than 1 mg/kg
2-methyl-1-propanol Not more than 10 mg/kg
Ethyl acetate Image omitted; see official source Not more than 350 mg/kg, singly or in combination
Propan-2-ol Image omitted; see official source Not more than 350 mg/kg, singly or in combination
Propylene glycol Image omitted; see official source 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 sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

E 474 SUCROGLYCERIDES
Synonyms Sugar glycerides
Definition Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids (including lauric acid) together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propan-2-ol
Einecs
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 40 % and not more than 60 % of sucrose fatty acid esters
Description Soft solid masses, stiff gels or white to off-white powders
Identification Identification
Test for sugar Passes test
Test for fatty acids Passes test
Solubility Insoluble in cold water, soluble in ethanol
Purity Purity
Sulphated ash Not more than 2 % (800 ± 25 °C)
Free sugar Not more than 5 %
Free fatty acids Not more than 3 % (estimated as oleic acid)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Methanol Not more than 10 mg/kg
Dimethylformamide Not more than 1 mg/kg
2-Methyl-1-propanol Image omitted; see official source Not more than 10 mg/kg, single or in combination
Cyclohexane Image omitted; see official source Not more than 10 mg/kg, single or in combination
Ethyl acetate Image omitted; see official source Not more than 350 mg/kg, single or in combination
Propan-2-ol Image omitted; see official source Not more than 350 mg/kg, single or in combination

Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

E 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. The polyglycerol is produced from glycerol complying with the specifications for E 422.
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 0,1 mg/kg
Lead Not more than 0,3 mg/kg
Mercury Not more than 0,1 mg/kg
Cadmium Not more than 0,1 mg/kg
Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD Not more than 2,5 mg/kg
Glycidyl fatty acid esters, expressed as glycidol Not more than 10 mg/kg. This applies from 20 July 2023 until 20 January 2024. Not more than 5 mg/kg. This applies from 20 January 2024.
Erucic acid Not more than 2 %

Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

E 476 POLYGLYCEROL POLYRICINOLEATE
Synonyms Glycerol esters of condensed castor oil fatty acids; Polyglycerol esters of polycondensed fatty acids from castor oil; Polyglycerol esters of interesterified ricinoleic acid; PGPR
Definition Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids. Castor oil used for the production of polyglycerol polyricinoleate is free of ricin. The polyglycerol is produced from glycerol complying with the specifications for E 422.
Einecs
Chemical name
Chemical formula
Molecular weight
Assay
Description Clear, highly viscous liquid
Identification
Solubility Insoluble in water and in ethanol; soluble in ether, hydrocarbons and halogenated hydrocarbons
Test for glycerol Passes test
Test for polyglycerols Passes test
Test for ricinoleic acid Passes test
Refractive index [n]D 65 between 1,4630 and 1,4665
Purity
Polyglycerols The polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol
Hydroxyl value Not less than 80 and not more than 100
Acid value Not more than 6
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg
Cadmium Not more than 0,1 mg/kg
Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD) Not more than 2,5 mg/kg
Glycidyl fatty acid esters (expressed as glycidol) 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 Identification
Test for propylene glycol Passes test
Test for fatty acids Passes test
Purity Purity
Sulphated ash Not more than 0,5 % (800 ± 25 °C)
Acids other than fatty acids Less than 1 %
Free fatty acids Not more than 6 % estimated as oleic acid
Total propane-1,2-diol Not less than 11 % and not more than 31 %
Free propane-1,2-diol Not more than 5 %
Dimer and trimer of propylene glycol Not more than 0,5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg

Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms TOSOM
Definition Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and deodorisation under vacuum at 130 °C of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from strains of soya beans
Einecs
Chemical name
Chemical formula
Molecular weight
Assay
Description Pale yellow to light brown a waxy or solid consistency
Identification Identification
Solubility Insoluble in water. Soluble in hot oil or fat
Purity 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 amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
Einecs 246-929-7
Chemical name Sodium di-2-stearoyl lactate Sodium di(2-stearoyloxy)propionate
Chemical formula C21H39O4Na; C19H35O4Na (major components)
Molecular weight
Assay
Description White or slightly yellowish powder or brittle solid with a characteristic odour
Identification 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 Purity
Sodium Not less than 2,5 % and not more than 5 %
Ester value Not less than 90 and not more than 190
Acid value Not less than 60 and not more than 130
Total lactic acid Not less than 15 % and not more than 40 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg

E 482 CALCIUM STEAROYL-2-LACTYLATE
Synonyms Calcium stearoyl lactate
Definition A mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
Einecs 227-335-7
Chemical name Calcium di-2-stearoyl lactate Calcium di(2-stearoyloxy)propionate
Chemical formula C42H78O8Ca; C38H70O8Ca, C40H74O8Ca (major components)
Molecular weight
Assay
Description White or slightly yellowish powder or brittle solid with a characteristic odour
Identification 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 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 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 Identification
Solubility Soluble at temperatures above its melting point in toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in petroleum ether and acetone; insoluble in cold water but dispersible in warm water; soluble with haze at temperatures above 50 °C in mineral oil and ethyl acetate
Identification test By acid value, iodine value (not more than 4), gas chromatography
Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
Purity Purity
Water content Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 10
Saponification value Not less than 147 and not more than 157
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 Identification
Solubility Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether, mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol
Identification test By acid value, iodine value (not more than 4), gas chromatography
Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
Purity Purity
Water content Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 15
Saponification value Not less than 176 and not more than 188
Hydroxyl value Not less than 66 and not more than 80
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg

E 493 SORBITAN MONOLAURATE
Synonyms
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid
Einecs 215-663-3
Chemical name
Chemical formula
Molecular weight
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 Identification
Solubility Dispersible in hot and cold water
Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
Purity Purity
Water content Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 7
Saponification value Not less than 155 and not more than 170
Hydroxyl value Not less than 330 and not more than 358
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg

E 494 SORBITAN MONOOLEATE
Synonyms
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate
Einecs 215-665-4
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide esters
Description Amber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
Identification Identification
Solubility Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetra-chloride. Insoluble in cold water, dispersible in warm water
Iodine value The residue of oleic acid, obtained from the saponification of the sorbitan monooleate in assay, has a iodine value between 80 and 100
Purity Purity
Water content 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 Identification
Solubility Soluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water
Identification test By acid value, iodine value (not more than 4), gas chromatography
Infrared absorption spectrum Characteristic of a partial fatty acid ester of polyol
Purity Purity
Water content Not more than 2 % (Karl Fischer method)
Sulphate ash Not more than 0,5 %
Acid value Not more than 7,5
Saponification value Not less than 140 and not more than 150
Hydroxyl value Not less than 270 and not more than 305
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg

E 499 STIGMASTEROL-RICH PLANT STEROLS
Synonyms
Definition Stigmasterol-rich plant sterols are derived from soybeans and are a chemically defined simple mixture that comprises not less than 95 % of plant sterols (stigmasterol, β-sitosterol, campesterol and brassicasterol), with stigmasterol representing not less than 85 % of the stigmasterol-rich plant sterols.
Einecs
Chemical name
Stigmasterol (3S,8S,9S,10R,13R,14S,17R)-17-(5-ethyl-6-methyl-hept-3-en-2-yl)-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol
β-Sitosterol (3S,8S,9S,10R,13R,14S,17R)-17-[(2S,5S)-5-ethyl-6-methylheptan-2-yl]-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol
Campesterol (3S,8S,9S,10R,13R,14S,17R)-17-(5,6-dimethylheptan-2-yl)-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol
Brassicasterol (3S,8S,9S,10R,13R,14S,17R)-17-[(E,2R,5R)-5,6-dimethylhept-3-en-2-yl]-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol
Chemical formula
Stigmasterol C29H48O
β-Sitosterol C29H50O
Campesterol C28H48O
Brassicasterol C28H46O
Molecular weight
Stigmasterol 412,6 g/mol
β-Sitosterol 414,7 g/mol
Campesterol 400,6 g/mol
Brassicasterol 398,6 g/mol
Assay (products containing only free sterols and stanols) Content not less than 95 % on a total free sterol/stanol basis on the anhydrous basis
Description Free-flowing, white to off-white powders, pills or pastilles; colourless to pale yellow liquids
Identification
Solubility Practically insoluble in water. Phytosterols and phytostanols are soluble in acetone and ethyl acetate.
Stigmasterol content Not less than 85 % (w/w)
Other plant sterols/stanols: either singularly or in combination including Brassicasterol, campestanol, campesterol, Δ-7-campesterol, cholesterol, chlerosterol, sitostanol and β-sitosterol. Not more than 15 % (w/w)
Purity
Total Ash Not more than 0,1 %
Residual Solvents Ethanol: Not more than 5 000  mg/kg
Residual Solvents Methanol: Not more than 50 mg/kg
Water content Not more than 4 % (Karl Fischer method)
Arsenic Not more than 3 mg/kg
Lead Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 1 000 CFU/g
Yeasts Not more than 100 CFU/g
Moulds Not more than 100 CFU/g
Escherichia coli Not more than 10 CFU/g
Salmonella spp. Absent in 25 g

E 500 (i) SODIUM CARBONATE
Synonyms Soda ash
Definition Definition
Einecs 207-838-8
Chemical name Sodium carbonate
Chemical formula Na2CO3 · nH2O (n = 0, 1 or 10)
Molecular weight 106,00 (anhydrous)
Assay Content not less than 99 % of Na2CO3 on the anhydrous basis
Description Colourless crystals or white, granular or crystalline powder The anhydrous form is hygroscopic, the decahydrate efflorescent
Identification Identification
Test for sodium Passes test
Test for carbonate Passes test
Solubility Freely soluble in water. Insoluble in ethanol
Purity 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 Definition
Einecs 205-633-8
Chemical name Sodium hydrogen carbonate
Chemical formula NaHCO3
Molecular weight 84,01
Assay Content not less than 99 % on the anhydrous basis
Description Colourless or white crystalline masses or crystalline powder
Identification 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 Purity
Loss on drying Not more than 0,25 % (over silica gel, 4 hours)
Ammonium salts No odour of ammonia 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 Definition
Einecs 208-580-9
Chemical name Sodium monohydrogen dicarbonate
Chemical formula Na2CO3 · NaHCO3 · 2H2O
Molecular weight 226,03
Assay Content between 35,0 % and 38,6 % of NaHCO3 and between 46,4 % and 50,0 % of Na2CO3
Description White flakes, crystals or crystalline powder
Identification Identification
Test for sodium Passes test
Test for carbonate Passes test
Solubility Freely soluble in water
Purity 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 Definition
Einecs 209-529-3
Chemical name Potassium carbonate
Chemical formula K2CO3 · nH2O (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 Identification
Test for potassium Passes test
Test for carbonate Passes test
Solubility Very soluble in water. Insoluble in ethanol
Purity 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 Definition
Einecs 206-059-0
Chemical name Potassium hydrogen carbonate
Chemical formula KHCO3
Molecular weight 100,11
Assay Content not less than 99,0 % and not more than 101,0 % KHCO3 on the anhydrous basis
Description Colourless crystals or white powder or granules
Identification Identification
Test for potassium Passes test
Test for carbonate Passes test
Solubility Freely soluble in water. Insoluble in ethanol
Purity Purity
Loss on drying Not more than 0,25 % (over silica gel, 4 hours)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 503 (i) AMMONIUM CARBONATE
Synonyms
Definition Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions
Einecs 233-786-0
Chemical name Ammonium carbonate
Chemical formula CH6N2O2, CH8N2O3 and CH5NO3
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 NH3
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 Identification
Test for ammonium Passes test
Test for carbonate Passes test
pH About 8,6 (5 % solution)
Solubility Soluble in water
Purity 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 Definition
Einecs 213-911-5
Chemical name Ammonium hydrogen carbonate
Chemical formula CH5NO3
Molecular weight 79,06
Assay Content not less than 99,0 %
Description White crystals or crystalline powder
Identification 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 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 MgCO3 · nH2O
Assay Not less than 24 % and not more than 26,4 % of Mg
Description Odourless, light, white friable masses or as a bulky white powder
Identification Identification
Test for magnesium Passes test
Test for carbonate Passes test
Solubility Practically insoluble both in water or ethanol
Purity 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 Definition
Einecs 235-192-7
Chemical name Magnesium carbonate hydroxide hydrated
Chemical formula 4MgCO3Mg(OH)2 · 5H2O
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 Identification
Test for magnesium Passes test
Test for carbonate Passes test
Solubility Practically insoluble in water. Insoluble in ethanol
Purity 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 Definition
Einecs 231-595-7
Chemical name Hydrochloric acid
Chemical formula HCl
Molecular weight 36,46
Assay Hydrochloric acid is commercially 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 Identification
Test for acid Passes test
Test for chloride Passes test
Solubility Soluble in water and in ethanol
Purity Purity
Total organic compounds Total organic compounds (non-fluorine containing): not more than 5 mg/kg Benzene: not more than 0,05 mg/kg Fluorinated compounds (total): not more than 25 mg/kg
Non-volatile matter Not more than 0,5 %
Reducing substances Not more than 70 mg/kg (as SO2)
Oxidising substances Not more than 30 mg/kg (as Cl2)
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 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 Identification
Solubility Freely soluble in water. Insoluble in ethanol
Test for potassium Passes test
Test for chloride Passes test
Purity Purity
Loss on drying Not more than 1 % (105 °C, 2 hours)
Test for sodium Negative
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 Definition
Einecs 233-140-8
Chemical name Calcium chloride
Chemical formula CaCl2 · nH2O (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 Identification
Test for calcium Passes test
Test for chloride Passes test
Solubility Soluble in water and in ethanol
Purity 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 Definition
Einecs 232-094-6
Chemical name Magnesium chloride
Chemical formula MgCl2 · 6H2O
Molecular weight 203,30
Assay Content not less than 99,0 %
Description Colourless, odourless, very deliquescent flakes or crystals
Identification Identification
Test for magnesium Passes test
Test for chloride Passes test
Solubility Very soluble in water, freely soluble in ethanol
Purity 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 Definition
Einecs 231-868-0
Chemical name Stannous chloride dihydrate
Chemical formula SnCl2 · 2H2O
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 Identification
Test for tin (II) Passes test
Test for chloride Passes test
Solubility Water: soluble in less than its own weight of water, but it forms an insoluble basic salt with excess water Ethanol: soluble
Purity 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 Definition
Einecs 231-639-5
Chemical name Sulphuric acid
Chemical formula H2SO4
Molecular weight 98,07
Assay Sulphuric acid is commercially available in varying concentrations. The concentrated form contains not less than 96,0 %
Description Clear, colourless or slightly brown, very corrosive oily liquid
Identification Identification
Test for acid Passes test
Test for sulphate Passes test
Solubility Miscible with water, with generation of much heat, also with ethanol
Purity Purity
Ash Not more than 0,02 %
Reducing matter Not more than 40 mg/kg (as SO2)
Nitrate Not more than 10 mg/kg (on H2SO4 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 Definition
Einecs
Chemical name Sodium sulphate
Chemical formula Na2SO4 · nH2O (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 Identification
Test for sodium Passes test
Test for sulphate Passes test
pH Neutral or slightly alkaline to litmus paper (5 % solution)
Purity Purity
Loss on drying Not more than 1,0 % (anhydrous) or not more than 57 % (decahydrate) at 130 °C
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 514 (ii) SODIUM HYDROGEN SULPHATE
Synonyms Acid sodium sulphate; Sodium bisulphate; Nitre cake
Definition Definition
Chemical name Sodium hydrogen sulphate
Chemical formula NaHSO4
Molecular weight 120,06
Assay Content not less than 95,2 %
Description White, odourless crystals or granules
Identification Identification
Test for sodium Passes test
Test for sulphate Passes test
pH Solutions are strongly acidic
Purity Purity
Loss on drying Not more than 0,8 %
Water insoluble matter Not more than 0,05 %
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 515 (i) POTASSIUM SULPHATE
Synonyms
Definition Definition
Einecs
Chemical name Potassium sulphate
Chemical formula K2SO4
Molecular weight 174,25
Assay Content not less than 99,0 %
Description Colourless or white crystals or crystalline powder
Identification 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 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 Definition
Einecs
Chemical name Potassium hydrogen sulphate
Chemical formula KHSO4
Molecular weight 136,17
Assay Content not less than 99 %
Description White deliquescent crystals, pieces or granules
Identification Identification
Melting point 197 °C
Test for potassium Passes test
Solubility Freely soluble in water, insoluble in ethanol
Purity 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 Definition
Einecs 231-900-3
Chemical name Calcium sulphate
Chemical formula CaSO4 · nH2O (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 Identification
Test for calcium Passes test
Test for sulphate Passes test
Solubility Slightly soluble in water, insoluble in ethanol
Purity 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 Definition
Einecs 231-984-1
Chemical name Ammonium sulphate
Chemical formula (NH4)2SO4
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 Identification
Test for ammonium Passes test
Test for sulphate Passes test
Solubility Freely soluble in water, insoluble in ethanol
Purity 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 Definition
Einecs
Chemical name Aluminium sulphate
Chemical formula Al2(SO4)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 Identification
Test for aluminium Passes test
Test for sulphate Passes test
pH 2,9 or above (5 % solution)
Solubility Freely soluble in water, insoluble in ethanol
Purity Purity
Loss on ignition Not more than 5 % (500 °C, 3 hours)
Alkalies and alkaline earths Not more than 0,4 %
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg

E 521 ALUMINIUM SODIUM SULPHATE
Synonyms Soda alum; Sodium alum
Definition Definition
Einecs 233-277-3
Chemical name Aluminium sodium sulphate
Chemical formula AlNa(SO4)2 · nH2O (n = 0 or 12)
Molecular weight 242,09 (anhydrous)
Assay Content on the anhydrous basis not less than 96,5 % (anhydrous) and 99,5 % (dodecahydrate)
Description Transparent crystals or white crystalline powder
Identification 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 Purity
Loss on drying Anhydrous form: not more than 10,0 % (220 °C, 16 hours) Dodecahydrate: not more than 47,2 % (50-55 °C, 1 hour then 200 °C, 16 hours)
Ammonium salts No odour of ammonia detectable after heating
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg

E 522 ALUMINIUM POTASSIUM SULPHATE
Synonyms Potassium alum; Potash alum
Definition Definition
Einecs 233-141-3
Chemical name Aluminium potassium sulphate dodecahydrate
Chemical formula AlK(SO4)2 · 12 H2O
Molecular weight 474,38
Assay Content not less than 99,5 %
Description Large, transparent crystals or white crystalline powder
Identification Identification
Test for aluminium Passes test
Test for potassium Passes test
Test for sulphate Passes test
pH Between 3,0 and 4,0 (10 % solution)
Solubility Freely soluble in water, insoluble in ethanol
Purity Purity
Ammonium salts No odour of ammonia detectable after heating
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg

E 523 ALUMINIUM AMMONIUM SULPHATE
Synonyms Ammonium alum
Definition Definition
Einecs 232-055-3
Chemical name Aluminium ammonium sulphate
Chemical formula AlNH4(SO4)2 · 12 H2O
Molecular weight 453,32
Assay Content not less than 99,5 %
Description Large, colourless crystals or white powder
Identification 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 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 Definition
Einecs 215-185-5
Chemical name Sodium hydroxide
Chemical formula NaOH
Molecular weight 40,0
Assay Content of solid forms not less than 98,0 % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH
Description White or nearly white pellets, flakes, sticks, fused masses or other forms. Solutions are clear or slightly turbid, colourless or slightly coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate
Identification Identification
Test for sodium Passes test
pH Strongly alkaline (1 % solution)
Solubility Very soluble in water. Freely soluble in ethanol
Purity Purity
Water insoluble and organic matter A 5 % solution is completely clear and colourless to slightly coloured
Carbonate Not more than 0,5 % (as Na2CO3)
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 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 Identification
Test for potassium Passes test
pH Strongly alkaline (1 % solution)
Solubility Very soluble in water. Freely soluble in ethanol
Purity Purity
Water insoluble matter A 5 % solution is completely clear and colourless
Carbonate Not more than 3,5 % (as K2CO3)
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 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 Identification
Test for alkali Passes test
Test for calcium Passes test
Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Purity 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 Definition
Einecs
Chemical name Ammonium hydroxide
Chemical formula NH4OH
Molecular weight 35,05
Assay Content not less than 27 % of NH3
Description Clear, colourless solution, having an exceedingly pungent, characteristic odour
Identification Identification
Test for ammonia Passes test
Purity 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 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 Identification
Test for magnesium Passes test
Test for alkali Passes test
Solubility Practically insoluble in water and in ethanol
Purity 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 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 Identification
Test for alkali Passes test
Test for calcium Passes test
Reaction with water Heat is generated on moistening the sample with water
Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Purity 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 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 dense, white powder known as heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of at least 33 ml, while 5 g of heavy magnesium oxide occupy a volume of not more than 20 ml
Identification Identification
Test for alkali Passes test
Test for magnesium Passes test
Solubility Practically insoluble in water. Insoluble in ethanol
Purity 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 534 IRON TARTRATE
Synonyms Iron meso-tartrate; complexation product of sodium tartrate with iron(III) chloride
Definition Iron tartrate is manufactured by the isomerisation of L-tartrate to an equilibrium mixture of D-, L- and meso-tartrate followed by addition of iron(III) chloride.
CAS number 1280193-05-9
Chemical name Iron(III) complexation product of D(+)-, L(-)- and meso-2,3 dihydroxybutanedioic acids
Chemical formula Fe(OH)2 C4H4O6Na
Molecular weight 261,93
Assay Assay
meso-tartrate > 28 %, expressed as the anion on dry basis
D(-)- and L(+)-tartrate > 10 %, expressed as the anion on dry basis
Iron(III) > 8 %, expressed as the anion on dry basis
Description Dark green aqueous solution typically comprising ca 35 % by weight complexation products
Identification Highly soluble in water
Positive tests for tartrate and iron
pH of a 35 % aqueous solution of complexation products between 3,5 and 3,9
Purity Purity
Chloride Not more than 25 %
Sodium Not more than 23 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Oxalate Not more than 1,5 % expressed as oxalate on dry basis

E 535 SODIUM FERROCYANIDE
Synonyms Yellow prussiate of soda; Sodium hexacyanoferrate
Definition Definition
Einecs 237-081-9
Chemical name Sodium ferrocyanide
Chemical formula Na4Fe(CN)6 · 10 H2O
Molecular weight 484,1
Assay Content not less than 99,0 %
Description Yellow crystals or crystalline powder
Identification Identification
Test for sodium Passes test
Test for ferrocyanide Passes test
Purity 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 Definition
Einecs 237-722-2
Chemical name Potassium ferrocyanide
Chemical formula K4Fe(CN)6 · 3 H2O
Molecular weight 422,4
Assay Content not less than 99,0 %
Description Lemon yellow crystals
Identification Identification
Test for potassium Passes test
Test for ferrocyanide Passes test
Purity 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 Definition
Einecs 215-476-7
Chemical name Calcium ferrocyanide
Chemical formula Ca2Fe(CN)6 · 12H2O
Molecular weight 508,3
Assay Content not less than 99,0 %
Description Yellow crystals or crystalline powder
Identification Identification
Test for calcium Passes test
Test for ferrocyanide Passes test
Purity 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 Definition
Einecs 232-090-4
Chemical name Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A); Trisodium dialuminium pentadecahydrogen octaphosphate (B)
Chemical formula NaAl3H14(PO4)8 · 4H2O (A) Na3Al2H15(PO4)8 (B)
Molecular weight 949,88 (A) 897,82 (B)
Assay Content not less than 95,0 % (both forms)
Description White odourless powder
Identification 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 Purity
Loss on ignition 19,5-21,0 % (A) (750-800 °C, 2 hours) 15-16 % (B) (750-800 °C, 2 hours)
Fluoride Not more than 25 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg

E 551 SILICON DIOXIDE
Synonyms Silica; Silicium dioxide
Definition Silicon dioxide is an amorphous substance, which is produced synthetically by either a vapour-phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. Fumed silica is produced in essentially an anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed water
Einecs 231-545-4
Chemical name Silicon dioxide
Chemical formula (SiO2)n
Molecular weight 60,08 (SiO2)
Assay Content after ignition not less than 99,0 % (fumed silica) or 94,0 % (hydrated forms)
Description White, fluffy powder or granules. Hygroscopic
Identification Identification
Test for silica Positive
Purity 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 % after drying (1 000  °C, hydrated forms)
Soluble ionisable salts Not more than 5,0 % (as Na2SO4)
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 SiO2. 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 SiO2 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 Identification
Test for silicate Passes test
Test for calcium Passes test
Gel formation Forms a gel with mineral acids
Purity Purity
Loss on drying Not more than 10 % (105 °C, 2 hours)
Loss on ignition Not less than 5 % and not more than 14 % (1 000  °C, constant weight)
Sodium Not more than 3 %
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 553a (i) MAGNESIUM SILICATE
Synonyms
Definition Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5
Einecs
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 15 % of MgO and not less than 67 % of SiO2 on the ignited basis
Description Very fine, white, odourless powder, free from grittiness
Identification Identification
Test for magnesium Passes test
Test for silicate Passes test
pH Between 7,0 and 10,8 (10 % slurry)
Purity 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 Definition
Einecs 239-076-7
Chemical name Magnesium trisilicate
Chemical formula Mg2Si3O8 · nH2O (approximate composition)
Molecular weight
Assay Content not less than 29,0 % of MgO and not less than 65,0 % of SiO2 both on the ignited basis
Description Fine, white powder, free from grittiness
Identification Identification
Test for magnesium Passes test
Test for silicate Passes test
pH Between 6,3 and 9,5 (5 % slurry)
Purity Purity
Loss on ignition Not less than 17 % and not more than 34 % (1 000  °C)
Water soluble salts Not more than 2 %
Free alkali Not more than 1 % (as NaOH)
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg

E 553b TALC

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