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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

E 283 POTASSIUM PROPIONATE
Synonyms
Definition Definition
Einecs 206-323-5
Chemical name Potassium propionate; Potassium propanoate
Chemical formula C3H5KO2
Molecular weight 112,17
Assay Content not less than 99 % after drying for two hours at 105 °C
Description White crystalline powder
Identification Identification
Test for propionate Passes test
Test for potassium Passes test
Purity Purity
Loss on drying Not more than 4 % (105 °C, 2 hours)
Water insoluble matter Not more than 0,1 %
Iron Not more than 30 mg/kg
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg

E 284 BORIC ACID
Synonyms Boracic acid; Orthoboric acid; Borofax
Definition Definition
Einecs 233-139-2
Chemical name
Chemical formula H3BO3
Molecular weight 61,84
Assay Content not less than 99,5 %
Description Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite
Identification Identification
Melting point At approximately 171 °C
Burning test Burns with a nice green flame
pH 3,8-4,8 (3,3 % aqueous solution)
Purity Purity
Peroxides No colour develops with added KI-solution
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg

E 285 SODIUM TETRABORATE (BORAX)
Synonyms Sodium borate
Definition Definition
Einecs 215-540-4
Chemical name Sodium tetraborate; Sodium biborate; Sodium pyroborate; Anhydrous tetraborate
Chemical formula Na2B4O7 Na2B4O7·10H2O
Molecular weight 201,27
Assay
Description Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water
Identification Identification
Melting range Between 171 °C and 175 °C with decomposition
Purity Purity
Peroxides No colour develops with added KI-solution
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg

E 290 CARBON DIOXIDE
Synonyms Carbonic acid gas; Dry ice (solid form); Carbonic anhydride
Definition Definition
Einecs 204-696-9
Chemical name Carbon dioxide
Chemical formula CO2
Molecular weight 44,01
Assay Content not less than 99 % v/v on the gaseous basis
Description A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised cylinders or bulk storage systems, or in compressed solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders
Identification 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 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 which has been added 3 ml of ammonia must not cause clouding or blackening of this solution
Carbon monoxide Not more than 10 μl/l
Oil content Not more than 5 mg/kg

E 296 MALIC ACID
Synonyms Pomalous acid
Definition Definition
Einecs 230-022-8, 210-514-9, 202-601-5
Chemical name hydroxybutanedioic acid; hydroxysuccinic acid
Chemical formula C4H6O5
Molecular weight 134,09
Assay Content not less than 99,0 %
Description White or nearly white crystalline powder or granules
Identification Identification
Melting range 127-132 °C
Test for malate Passes test
Purity 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 Definition
Einecs 203-743-0
Chemical name trans-Butenedioic acid; trans-1,2-Ethylene-dicarboxylic acid
Chemical formula C4H4O4
Molecular weight 116,07
Assay Content not less than 99,0 % on the anhydrous basis
Description White crystalline powder or granules
Identification Identification
Melting range 286-302 °C (closed capillary, rapid heating)
Test for double bonds Passes test
Test for 1,2-dicarboxylic acid Passes test
pH 3,0-3,2 (0,05 % solution at 25 °C)
Purity Purity
Loss on drying Not more than 0,5 % (120 °C, 4 hours)
Sulphated ash Not more than 0,1 %
Maleic acid Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 300 ASCORBIC ACID, L-ASCORBIC ACID
Synonyms L-xylo-Ascorbic acid; L(+)- Ascorbic acid
Definition Definition
Einecs 200-066-2
Chemical name L-ascorbic acid; Ascorbic acid; 2,3-Didehydro-L-threo-hexono-1,4-lactone; 3-Keto-L-gulofuranolactone
Chemical formula C6H8O6
Molecular weight 176,13
Assay contains not less than 99 % of C6H8O6 after drying in a vacuum desiccator over sulphuric acid for 24 hours,
Description White to pale yellow, odourless crystalline powder
Melting range Between 189 °C and 193 °C with decomposition
Identification Identification
Test for ascorbic acid Passes test
pH Between 2,4 and 2,8 (2 % aqueous solution)
Specific rotation [α]D 20 between + 20,5° and + 21,5° (10 % w/v aqueous solution)
Purity 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 Definition
Einecs 205-126-1
Chemical name Sodium ascorbate; Sodium L-ascorbate; 2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate; 3-Keto-L-gulofurano-lactone sodium enolate
Chemical formula C6H7O6Na
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 C6H7O6Na
Description White or almost white, odourless crystalline powder which darkens on exposure to light
Identification Identification
Test for ascorbate Passes test
Test for sodium Passes test
pH Between 6,5 and 8,0 (10 % aqueous solution)
Specific rotation [α]D 20 between + 103° and + 106° (10 % w/v aqueous solution)
Purity Purity
Loss on drying Not more than 0,25 % (in vacuum over sulphuric acid, 24 hours)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 302 CALCIUM ASCORBATE
Synonyms Calcium ascorbate dihydrate
Definition Definition
Einecs 227-261-5
Chemical name Calcium ascorbate dihydrate; Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate
Chemical formula C12H14O12Ca·2H2O
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 Identification
Test for ascorbate Passes test
Test for calcium Passes test
pH Between 6,0 and 7,5 (10 % aqueous solution)
Specific rotation [α]D 20 between + 95° and + 97° (5 % w/v aqueous solution)
Purity 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 Definition
Einecs 205-305-4
Chemical name Ascorbyl palmitate; L-ascorbyl palmitate; 2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate; 6-palmitoyl-3-keto-L-gulofuranolactone
Chemical formula C22H38O7
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 Identification
Melting range Between 107 °C and 117 °C
Specific rotation [α]D 20 between + 21° and + 24° (5 % w/v in methanol solution)
Purity Purity
Loss on drying Not more than 2,0 % (vacuum oven, 56-60 °C, 1 hour)
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 304 (ii) ASCORBYL STEARATE
Synonyms
Definition Definition
Einecs 246-944-9
Chemical name Ascorbyl stearate; L-ascorbyl stearate; 2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate; 6-stearoyl-3-keto-L-gulofuranolactone
Chemical formula C24H42O7
Molecular weight 442,6
Assay Content not less than 98 %
Description White or yellowish, white powder with a citrus-like odour
Identification Identification
Melting point About 116 °C
Purity Purity
Loss on drying Not more than 2,0 % (vacuum oven, 56-60 °C, 1 hour)
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 306 TOCOPHEROL-RICH EXTRACT
Synonyms
Definition Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols Contains tocopherols such as d-α-, d-β-, d-γ- and d-δ-tocopherols
Einecs
Chemical name
Chemical formula
Molecular weight 430,71 (d-α-tocopherol)
Assay Content not less than 34 % of total tocopherols
Description Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form
Identification Identification
By suitable gas liquid chromatographic method
Specific rotation [α]D 20 not less than + 20°
Solubility Insoluble in water. Soluble in ethanol. Miscible in ether
Purity 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 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 C29H50O2
Molecular weight 430,71
Assay Content not less than 96 %
Description Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidises and darkens on exposure to air or light
Identification Identification
Solubility Insoluble in water, freely soluble in ethanol, miscible in ether
Spectrophotometry In absolute ethanol the maximum absorption is about 292 nm
Specific rotation [α]D 25 0° ± 0,05° (1 in 10 solution in chloroform)
Purity Purity
Refractive index [n]D 20 1,503-1,507
Specific absorption in ethanol Image omitted; see official source (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 Definition
Einecs 231-523-4
Chemical name 2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Chemical formula C28H48O2
Molecular weight 416,69
Assay Content not less than 97 %
Description Clear, viscous, pale yellow oil which oxidises and darkens on exposure to air or light
Identification Identification
Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
Purity Purity
Specific absorption in ethanol Image omitted; see official source (298 nm) between 91 and 97Image omitted; see official source (257 nm) between 5,0 and 8,0
Refractive index [n]D 20 1,503-1,507
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 309 DELTA-TOCOPHEROL
Synonyms
Definition Definition
Einecs 204-299-0
Chemical name 2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Chemical formula C27H46O2
Molecular weight 402,7
Assay Content not less than 97 %
Description Clear, viscous, pale yellowish or orange oil which oxidises and darkens on exposure to air or light
Identification Identification
Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
Purity Purity
Specific absorption Image omitted; see official source in ethanol Image omitted; see official source (298 nm) between 89 and 95Image omitted; see official source (257 nm) between 3,0 and 6,0
Refractive index [n]D 20 1,500-1,504
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 310 PROPYL GALLATE
Synonyms
Definition Propyl gallate is produced by the esterification of gallic acid with propanol. The reaction is catalysed by sulphuric acid.
Einecs 204-498-2
Chemical name Propyl gallate; Propyl ester of gallic acid; n-propyl ester of 3,4,5-trihydroxybenzoic acid
Chemical formula C10H12O5
Molecular weight 212,20
Assay Content not less than 98 % on the anhydrous basis
Description White to creamy-white, crystalline, odourless solid
Identification 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 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)
Specific absorption in ethanol Image omitted; see official source (275 nm) not less than 485 and not more than 520
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,3 mg/kg
Mercury Not more than 0,1 mg/kg

E 315 ERYTHORBIC ACID
Synonyms Isoascorbic acid; D-Araboascorbic acid
Definition Definition
Einecs 201-928-0
Chemical name D-Erythro-hex-2-enoic acid γ-lactone; Isoascorbic acid; D-Isoascorbic acid
Chemical formula C6H8O6
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 Identification
Melting range About 164 °C to 172 °C with decomposition
Test for ascorbic acid/colour reaction Passes test
Specific rotation [α]D 25 10 % (w/v) aqueous solution between – 16,5° to – 18,0°
Purity 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 Definition
Einecs 228-973-9
Chemical name Sodium isoascorbate; Sodium D-isoascorbic acid; Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone; 3-keto-D-gulofurano-lactone sodium enolate monohydrate
Chemical formula C6H7O6Na·H2O
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 Identification
Solubility Freely soluble in water, very slightly soluble in ethanol
Test for ascorbic acid/colour reaction Passes test
Test for sodium Passes test
pH 5,5 to 8,0 (10 % aqueous solution)
Specific rotation [α]D 25 10 % (w/v) aqueous solution between + 95° and + 98°
Purity Purity
Loss on drying Not more than 0,25 % after drying (in vacuum over sulphuric acid, 24 hours)
Oxalate To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear.
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)
Synonyms TBHQ
Definition Definition
Einecs 217-752-2
Chemical name Tert-butyl-1,4-benzenediol; 2-(1,1-Dimethylethyl)-1,4-benzenediol
Chemical formula C10H14O2
Molecular weight 166,22
Assay Content not less than 99 % of C10H14O2
Description White crystalline solid having a characteristic odour
Identification 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 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 HYDROXYANISOLE (BHA)
Synonyms BHA
Definition 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 C11H16O2
Molecular weight 180,25
Assay Content not less than 98,5 % of C11H16O2 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 Identification
Solubility Insoluble in water, freely soluble in ethanol
Melting range Between 48 °C and 63 °C
Colour reaction Passes test for phenol groups
Purity Purity
Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 °C
Phenolic impurities Not more than 0,5 %
Specific absorption Image omitted; see official source (290 nm) not less than 190 and not more than 210Image omitted; see official source (228 nm) not less than 326 and not more than 345
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 321 BUTYLATED HYDROXYTOLUENE (BHT)
Synonyms BHT
Definition Definition
Einecs 204-881-4
Chemical name 2,6-Ditertiary-butyl-p-cresol; 4-Methyl-2,6-ditertiarybutylphenol
Chemical formula C15H24O
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 Identification
Solubility Insoluble in water and propane- 1,2-diol Freely soluble in ethanol
Melting point At 70 °C
Spectrometry The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm
Purity Purity
Sulphated ash Not more than 0,005 %
Phenolic impurities Not more than 0,5 %
Specific absorption in ethanol Image omitted; see official source (278 nm) not less than 81 and not more than 88
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 322 LECITHINS
Synonyms Phosphatides; Phospholipids
Definition Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides
Einecs 232-307-2
Chemical name
Chemical formula
Molecular weight
Assay Lecithins: not less than 60,0 % of substances insoluble in acetone Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone
Description Lecithins: brown liquid or viscous semi-liquid or powder Hydrolysed lecithins: light brown to brown viscous liquid or paste
Identification Identification
Test for choline Passes test
Test for phosphorus Passes test
Test for fatty acids Passes test
Test for hydrolysed lecithin To a 800 ml beaker add 500 ml of water (30-35 °C). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g
Purity 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 322a OAT LECITHIN
Synonyms Fractionated oat oil
Definition Oat lecithin is a fractionated oat oil rich in polar lipids, mainly galactolipids. Oat lecithin is produced from food grade oat kernels that are sieved and extracted using ethanol at an elevated temperature to produce a crude lipid extract. This crude extract undergoes multistage evaporation and filtration, yielding crude oat oil, which is separated, evaporated and filtered to produce oat lecithin. Only ethanol may be used in the extraction as extraction solvent.
Einecs 281-672-4
Assay Not less than 30 % of polar lipids insoluble in acetone
Description Yellowish-brown viscous liquid
Identification
Choline Not more than 2 g/100 g
Phosphorous Not less than 0,5 %
Polar lipids Not less than 35 % w/w
Neutral lipids 55–65 % w/w
Saturated 17–20 % w/w
Monounsaturated 38–42 % w/w
Polyunsaturated 38–42 % w/w
Purity
Loss of drying Not more than 2 %
Toluene-insoluble matter Not more than 1 % w/w
Acid value Not more than 30 mg KOH/g
Peroxide value less than 10 meq O2/kg fat
Solvent residues Ethanol: not more than 300 mg/kg
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,05 mg/kg
Mercury Not more than 0,02 mg/kg
Cadmium Not more than 0,05 mg/kg
Microbiological criteria
Aerobic plate count Not more than 1 000 CFU/g
Yeast Not more than 100 CFU/g
Moulds Not more than 100 CFU/g
Enterobacteriaceae Not more than 10 CFU/g
Aerobic spores Not more than 1 CFU/g
Other
Gluten Not more than 20 mg/kg

E 325 SODIUM LACTATE
Synonyms
Definition Definition
Einecs 200-772-0
Chemical name Sodium lactate; Sodium 2-hydroxypropanoate
Chemical formula C3H5NaO3
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 Identification
Test for lactate Passes test
Test for sodium Passes test
pH 6,5 to 7,5 (20 % aqueous solution)
Purity Purity
Acidity Not more than 0,5 % after drying expressed as lactic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Reducing substances No reduction of Fehling's solution

Note: This specification refers to a 60 % aqueous solution

E 326 POTASSIUM LACTATE
Synonyms
Definition Definition
Einecs 213-631-3
Cheminal name Potassium lactate; Potassium 2-hydroxypropanoate
Chemical formula C3H5O3K
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 slight, characteristic odour
Identification Identification
Ignition Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added
Colour reaction Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact
Test for potassium Passes test
Test for lactate Passes test
Purity 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 Definition
Einecs 212-406-7
Chemical name Calcium dilactate; Calcium dilactate hydrate; 2-Hydroxypropanoic acid calcium salt
Chemical formula (C3H5O2)2 Ca·nH2O (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 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 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, by fermentation of carbohydrate solutions or other suitable media using Candida spp. or non-toxicogenic strains of Aspergillus niger
Einecs 201-069-1
Chemical name Citric acid; 2-Hydroxy-1,2,3-propanetricarboxylic acid; β-Hydroxytricarballylic 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 anhydrous or it may contain 1 molecule of water. Citric acid contains not less than 99,5 % of C6H8O7, 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 Identification
Solubility Very soluble in water; freely soluble in ethanol; soluble in ether
Purity Purity
Water content Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method)
Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 °C
Arsenic Not more than 1 mg/kg
Lead Not more than 0,5 mg/kg
Mercury Not more than 1 mg/kg
Oxalates Not more than 100 mg/kg, expressed as oxalic acid, after drying
Readily carbonisable substances Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 °C in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)

E 331 (i) MONOSODIUM CITRATE
Synonyms Monobasic sodium citrate
Definition 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 Identification
Test for citrate Passes test
Test for sodium Passes test
pH Between 3,5 and 3,8 (1 % aqueous solution)
Purity Purity
Loss on drying anhydrous: not more than 1,0 % (140 °C, 0,5 hour) monohydrate: not more than 8,8 % (180 °C, 4 hours)
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg

E 331 (ii) DISODIUM CITRATE
Synonyms Dibasic sodium citrate
Definition Definition
Einecs 205-623-3
Chemical name Disodium citrate; Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Disodium salt of citric acid with 1,5 molecules of water
Chemical formula C6H6O7Na2·1,5H2O
Molecular weight 263,11
Assay Content not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification Identification
Test for citrate Passes test
Test for sodium Passes test
pH Between 4,9 and 5,2 (1 % aqueous solution)
Purity 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 Definition
Einecs 200-675-3
Chemical name Trisodium citrate; Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form
Chemical formula Anhydrous: C6H5O7Na3 Hydrated: C6H5O7Na3·nH2O (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 Identification
Test for citrate Passes test
Test for sodium Passes test
pH Between 7,5 and 9,0 (5 % aqueous solution)
Purity Purity
Loss of drying Anhydrous: not more than 1,0 % (180 °C, 18 hours) Dihydrate: 10,0 to 13,0 % (180 °C, 18 hours) Pentahydrate: not more than 30,3 % (180 °C, 4 hours)
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 332 (i) MONOPOTASSIUM CITRATE
Synonyms Monobasic potassium citrate
Definition Definition
Einecs 212-753-4
Chemical name Monopotassium citrate; Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Anhydrous monopotassium salt of citric acid
Chemical formula C6H7O7K
Molecular weight 230,21
Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent crystals
Identification Identification
Test for citrate Passes test
Test for potassium Passes test
pH Between 3,5 and 3,8 (1 % aqueous solution)
Purity 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 Definition
Einecs 212-755-5
Chemical name Tripotassium citrate; Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Monohydrated tripotassium salt of citric acid
Chemical formula C6H5O7K3·H2O
Molecular weight 324,42
Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent crystals
Identification Identification
Test for citrate Passes test
Test for potassium Passes test
pH Between 7,5 and 9,0 (5 % aqueous solution)
Purity 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 Definition
Einecs
Chemical name Monocalcium citrate; Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Monohydrate monocalcium salt of citric acid
Chemical formula (C6H7O7)2Ca·H2O
Molecular weight 440,32
Assay Content not less than 97,5 % on the anhydrous basis
Description Fine white powder
Identification Identification
Test for citrate Passes test
Test for calcium Passes test
pH Between 3,2 and 3,5 (1 % aqueous solution)
Purity Purity
Loss on drying Not more than 7,0 % (180 °C, 4 hours)
Oxalates Not more than 100 mg/kg (expressed as oxalic acid, after drying)
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 30 mg/kg (only if added to food for infants and young children) Not more than 200 mg/kg (for all uses except food for infants and young children)
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

E 333 (ii) DICALCIUM CITRATE
Synonyms Dibasic calcium citrate
Definition Definition
Einecs
Chemical name Dicalcium citrate; Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Trihydrated dicalcium salt of citric acid
Chemical formula (C6H7O7)2Ca2·3H2O
Molecular weight 530,42
Assay Not less than 97,5 % on the anhydrous basis
Description Fine white powder
Identification Identification
Test for citrate Passes test
Test for calcium Passes test
Purity Purity
Loss on drying Not more than 20,0 % (180 °C, 4 hours)
Oxalates Not more than 100 mg/kg (expressed as oxalic acid, after drying)
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 30 mg/kg (only if added to food for infants and young children) Not more than 200 mg/kg (for all uses except food for infants and young children)
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

E 333 (iii) TRICALCIUM CITRATE
Synonyms Tribasic calcium citrate
Definition Definition
Einecs 212-391-7
Chemical name Tricalcium citrate; Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Tetrahydrated tricalcium salt of citric acid
Chemical formula (C6H6O7)2Ca3·4H2O
Molecular weight 570,51
Assay Not less than 97,5 % on the anhydrous basis
Description Fine white powder
Identification Identification
Test for citrate Passes test
Test for calcium Passes test
Purity 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 calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

E 334 L(+)-TARTARIC ACID, TARTARIC ACID
Synonyms
Definition Definition
Einecs 201-766-0
Chemical name L-tartaric acid; L-2,3-dihydroxybutanedioic acid; d-α,β-dihydroxysuccinic acid
Chemical formula C4H6O6
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 Identification
Melting range Between 168 °C and 170 °C
Test for tartrate Passes test
Specific rotation [α]D 20 between + 11,5° and + 13,5° (20 % w/v aqueous solution)
Purity Purity
Loss on drying Not more than 0,5 % (over P2O5, 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 Definition
Einecs
Chemical name Monosodium salt of L-2,3-dihydroxybutanedioic acid; Monohydrated monosodium salt of L-(+)-tartaric acid
Chemical formula C4H5O6Na·H2O
Molecular weight 194,05
Assay Content not less than 99 % on the anhydrous basis
Description Transparent colourless crystals
Identification Identification
Test for tartrate Passes test
Test for sodium Passes test
Purity 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 Definition
Einecs 212-773-3
Chemical name Disodium L-tartrate; Disodium (+)-tartrate; Disodium salt of (+)-2,3-dihydroxybutanedioic acid; Dihydrated disodium salt of L-(+)-tartaric acid
Chemical formula C4H4O6Na2·2H2O
Molecular weight 230,8
Assay Content not less than 99 % on the anhydrous basis
Description Transparent, colourless crystals
Identification 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 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 Definition
Einecs
Chemical name Anhydrous monopotassium salt of L-(+)-tartaric acid; Monopotassium salt of L-2,3-dihydroxybutanedioic acid
Chemical formula C4H5O6K
Molecular weight 188,16
Assay Content not less than 98 % on the anhydrous basis
Description White crystalline or granulated powder
Identification Identification
Test for tartrate Passes test
Test for potassium Passes test
Melting point 230 °C
pH 3,4 (1 % aqueous solution)
Purity 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 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 C4H4O6K2·½H2O
Molecular weight 235,2
Assay Content not less than 99 % on the anhydrous basis
Description White crystalline or granulated powder
Identification Identification
Test for tartrate Passes test
Test for potassium Passes test
pH Between 7,0 and 9,0 (1 % aqueous solution)
Purity 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 Definition
Einecs 206-156-8
Chemical name Potassium sodium salt of L-2,3-dihydroxybutanedioic acid; Potassium sodium L-(+)-tartrate
Chemical formula C4H4O6KNa·4H2O
Molecular weight 282,23
Assay Content not less than 99 % on the anhydrous basis
Description Colourless crystals or white crystalline powder
Identification 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 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 Definition
Einecs 231-633-2
Chemical name Phosphoric acid
Chemical formula H3PO4
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 Identification
Test for acid Passes test
Test for phosphate Passes test
Purity 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 NaNO3)
Sulphates Not more than 1 500  mg/kg (as CaSO4)
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 Definition
Einecs 231-449-2
Chemical name Sodium dihydrogen monophosphate
Chemical formula Anhydrous: NaH2PO4 Monohydrate: NaH2PO4 · H2O Dihydrate: NaH2PO4 · 2H2O
Molecular weight Anhydrous: 119,98 Monohydrate: 138,00 Dihydrate: 156,01
Assay After drying at 60 °C for one hour and then at 105 °C for four hours, contains not less than 97 % of NaH2PO4 P2O5 content between 58,0 % and 60,0 % on the anhydrous basis
Description A white odourless, slightly deliquescent powder, crystals or granules
Identification 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 Purity
Loss on drying The anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, the dihydrate not more than 25 % (60 °C, 1 hour then 105 °C, 4 hours)
Water insoluble matter Not more than 0,2 % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)
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 Definition
Einecs 231-448-7
Chemical name Disodium hydrogen monophosphate; Disodium hydrogen orthophosphate
Chemical formula Anhydrous:Na2HPO4 Hydrate: Na2HPO4 · nH2O (n = 2, 7 or 12)
Molecular weight 141,98 (anhydrous)
Assay After drying at 40 °C for three hours and subsequently at 105 °C for five hours, contains not less than 98 % of Na2HPO4 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 heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals
Identification 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 Purity
Loss on drying The anhydrous salt loses not more than 5,0 %, the dihydrate not more than 22,0 %, the heptahydrate not more than 50,0 %, the dodecahydrate not more than 61,0 % (40 °C, 3 hours then 105 °C, 5 hours)
Water insoluble matter Not more than 0,2 % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg

E 339 (iii) TRISODIUM PHOSPHATE
Synonyms Sodium phosphate; Tribasic sodium phosphate; Trisodium orthophosphate
Definition Trisodium phosphate is obtained from aqueous solutions and crystallises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H2O. 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: Na3PO4 Hydrated: Na3PO4 nH2O (n = 1/2, 1, 6, 8, or 12)
Molecular weight 163,94 (anhydrous)
Assay Sodium phosphate anhydrous and the hydrated forms, with the exception of the dodecahydrate, contain not less than 97,0 % of Na3PO4 calculated on the dried basis. Sodium phosphate dodecahydrate contains not less than 92,0 % of Na3PO4 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 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 Purity
Loss on ignition When dried at 120 °C for two hours and then ignited at about 800 °C for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 %
Water insoluble matter Not more than 0,2 % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg

E 340 (i) MONOPOTASSIUM PHOSPHATE
Synonyms Monobasic potassium phosphate; Monopotassium monophosphate; Mono potassium orthophosphate
Definition Definition
Einecs 231-913-4
Chemical name Potassium dihydrogen phosphate; Monopotassium dihydrogen orthophosphate; Monopotassium dihydrogen monophosphate
Chemical formula KH2PO4
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 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 Purity
Loss on drying Not more than 2,0 % (105 °C, 4 hours)
Water insoluble matter Not more than 0,2 % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg

E 340 (ii) DIPOTASSIUM PHOSPHATE
Synonyms Dipotassium monophosphate; Secondary potassium phosphate; Dipotassium orthophosphate; Dibasic potassium phosphate
Definition Definition
Einecs 231-834-5
Chemical name Dipotassium hydrogen monophosphate; Dipotassium hydrogen phosphate; Dipotassium hydrogen orthophosphate
Chemical formula K2HPO4
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 granular powder, crystals or masses; deliquescent substance, hygroscopic
Identification 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 Purity
Loss on drying Not more than 2,0 % (105 °C, 4 hours)
Water insoluble matter Not more than 0,2 % (on the anhydrous basis)
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg

E 340 (iii) TRIPOTASSIUM PHOSPHATE
Synonyms Tribasic potassium phosphate; Tripotassium orthophosphate
Definition Definition
Einecs 231-907-1
Chemical name Tripotassium monophosphate; Tripotassium phosphate; Tripotassium orthophosphate
Chemical formula Anhydrous: K3PO4 Hydrated: K3PO4 · nH2O (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 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 Purity
Loss on ignition Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 % (determined by drying at 105 °C for one hour and then ignite at about 800 °C ± 25 °C for 30 minutes)
Water insoluble matter Not more than 0,2 % (on the anhydrous basis)
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg

E 341 (i) MONOCALCIUM PHOSPHATE
Synonyms Monobasic calcium phosphate; Monocalcium orthophosphate
Definition Definition
Einecs 231-837-1
Chemical name Calcium dihydrogen phosphate
Chemical formula Anhydrous: Ca(H2PO4)2 Monohydrate: Ca(H2PO4)2 · H2O
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 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 Purity
Loss on drying Anhydrous: not more than 14 % (105 °C, 4 hours) Monohydrate: not more than 17,5 % (105 °C, 4 hours)
Loss on ignition Anhydrous: not more than 17,5 % (after ignition at 800 °C ± 25 °C for 30 minutes) Monohydrate: not more than 25,0 % (determined by drying at 105 °C for one hour, then ignite at 800 °C ± 25 °C for 30 minutes)
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 70 mg/kg (only if added to food for infants and young children) Not more than 200 mg/kg (for all uses except food for infants and young children)

E 341 (ii) DICALCIUM PHOSPHATE
Synonyms Dibasic calcium phosphate; Dicalcium orthophosphate
Definition Definition
Einecs 231-826-1
Chemical name Calcium monohydrogen phosphate; Calcium hydrogen orthophosphate; Secondary calcium phosphate
Chemical formula Anhydrous: CaHPO4 Dihydrate: CaHPO4 · 2H2O
Molecular weight 136,06 (anhydrous) 172,09 (dihydrate)
Assay Dicalcium phosphate, after drying at 200 °C for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4 P2O5 content between 50,0 % and 52,5 % on the anhydrous basis
Description White crystals or granules, granular powder or powder
Identification Identification
Test for calcium Passes test
Test for phosphate Passes test
Solubility Sparingly soluble in water. Insoluble in ethanol
Purity Purity
Loss on ignition Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 °C ± 25 °C for 30 minutes
Fluoride Not more than 50 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 100 mg/kg for the anhydrous form and not more than 80 mg/kg for the dihydrated form (only if added to food for infants and young children) Not more than 600 mg/kg for the anhydrous form and not more than 500 mg/kg for the dihydrated form (for all uses except food for infants and young children). This applies until 31 March 2015. Not more than 200 mg/kg for the anhydrous form and the dihydrated form (for all uses except food for infants and young children). This applies from 1 April 2015.

E 341 (iii) TRICALCIUM PHOSPHATE
Synonyms Calcium phosphate, tribasic; Calcium orthophosphate; Pentacalcium hydroxy monophosphate; Calcium hydroxyapatite
Definition Tricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of phosphoric acid with calcium hydroxide or calcium carbonate and having the approximate composition of 10CaΟ·3P2O5·Η2O
Einecs 235-330-6 (Pentacalcium hydroxy monophosphate) 231-840-8 (Calcium orthophosphate)
Chemical name Pentacalcium hydroxy monophosphate; Tricalcium monophosphate
Chemical formula Ca5(PO4)3 ·OH or Ca3(PO4)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 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 Purity
Loss on ignition Not more than 8 % after ignition at 800 °C ± 25 °C for 0,5 hour
Fluoride Not more than 50 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 150 mg/kg (only if added to food for infants and young children) Not more than 500 mg/kg (for all uses except food for infants and young children). This applies until 31 March 2015 Not more than 200 mg/kg (for all uses except food for infants and young children). This applies from 1 April 2015.

E 343 (i) MONOMAGNESIUM PHOSPHATE
Synonyms Magnesiumdihydrogenphosphate; Magnesiumphosphate, monobasic; Monomagnesium orthophosphate
Definition Definition
Einecs 236-004-6
Chemical name Monomagnesiumdihydrogenmonophosphate
Chemical formula Mg(H2PO4)2 nH2O (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 Identification
Test for magnesium Passes test
Test for phosphate Passes test
MgO content Not less than 21,5 % after ignition or at an anhydrous basis (105 °C, 4 hours)
Purity 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 Definition
Einecs 231-823-5
Chemical name Dimagnesiummonohydrogenmonophosphate
Chemical formula MgHPO4 · nH2O (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 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 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 345 (i) TRIMAGNESIUM DICITRATE
Synonyms Magnesium citrate; trimagnesium citrate
Definition Definition
Einecs 222-093-9
Chemical name Trimagnesium bis (2-hydroxypropane-1,2,3- tricarboxylate), anhydrous
Chemical formula (C6H5O7)2 Mg3
Molecular weight 451,12 (anhydrous)
Assay 15,0-16,5 % Mg on dry substance/matter equal to 92,8-102,1 % trimagnesium dicitrate anhydrous
Description White or almost white, fine, slightly hygroscopic powder
Appearance of a solution Not more opalescent than ref. susp. III and not more intensely coloured than ref. sol. Y7 or BY6
Identification Identification
Test for citrate Positive
Test for magnesium Positive
pH (5 % solution) 6,0-8,5
Solubility Soluble in water, practically insoluble in ethanol (96 %), it dissolves in diluted hydrochloric acid.
Particle size by STEM method – Median (D50) particle size (number-based) not below 130 nm by laser diffraction method – Median (D50) particle size (mass-based) not below 50 μm
Purity Purity
Loss on drying Maximum 3,5 %, determined on 1 000 g by drying in an oven at 180 ± 10 °C for 5 h
Oxalic/oxalate ≤ 280 mg/kg (0,028 %) as oxalic acid
Sulfates ≤ 2 000 mg/kg (0,2 %)
Calcium ≤ 2 000 mg/kg (0,2 %)
Iron ≤ 100 mg/kg
Mercury ≤ 0,1 mg/kg
Lead ≤ 1 mg/kg
Cadmium ≤ 0,1 mg/kg
Arsenic ≤ 1 mg/kg
Not identified material No process or product related impurities. The unintended presence of hydrated forms of trimagnesium dicitrate such as the nonahydrate cannot be excluded.

E 350 (i) SODIUM MALATE
Synonyms Sodium salt of malic acid
Definition Definition
Einecs
Chemical name Disodium DL-malate; disodium salt of hydroxybutanedioic acid
Chemical formula Hemihydrate: C4H4Na2O5 ½ H2O Trihydrate: C4H4Na2O5 3H2O
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 Identification
Test for 1,2-dicarboxylic acid Passes test
Test for sodium Passes test
Azo dye formation Positive
Solubility Freely soluble in water
Purity 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 Na2CO3
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 Definition
Einecs
Chemical name Monosodium DL-malate; monosodium 2-DL-hydroxy succinate
Chemical formula C4H5NaO5
Molecular weight 156,07
Assay Content not less than 99,0 % on the anhydrous basis
Description White powder
Identification Identification
Test for 1,2-dicarboxylic acid Passes test
Test for sodium Passes test
Azo dye formation Positive
Purity Purity
Loss on drying Not more than 2,0 % (110 °C, 3 hours)
Maleic acid Not more than 0,05 %
Fumaric acid Not more than 1,0 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 351 POTASSIUM MALATE
Synonyms Potassium salt of malic acid
Definition Definition
Einecs
Chemical name Dipotassium DL-malate; dipotassium salt of hydroxybutanedioic acid
Chemical formula C4H4K2O5
Molecular weight 210,27
Assay Content not less than 59,5 %
Description Colourless or almost colourless aqueous solution
Identification Identification
Test for 1,2-dicarboxylic acid Passes test
Test for potassium Passes test
Azo dye formation Positive
Purity Purity
Alkalinity Not more than 0,2 % as K2CO3
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 Definition
Einecs
Chemical name Calcium DL-malate; calcium-α-hydroxysuccinate; calcium salt of hydroxybutanedioic acid
Chemical formula C4H5CaO5
Molecular weight 172,14
Assay Content not less than 97,5 % on the anhydrous basis
Description White powder
Identification Identification
Test for malate Passes test
Test 1,2-dicarboxylic acid Passes test
Test for calcium Passes test
Azo dye formation Positive
Solubility Slightly soluble in water
Purity Purity
Loss on drying Not more than 2 % (100 °C, 3 hours)
Alkalinity Not more than 0,2 % as CaCO3
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 Definition
Einecs
Chemical name Monocalcium DL-malate; monocalcium 2-DL-hydroxysuccinate
Chemical formula (C4H5O5)2Ca
Molecular weight
Assay Content not less than 97,5 % on the anhydrous basis
Description White powder
Identification Identification
Test for 1,2-dicarboxylic acid Passes test
Test for calcium Passes test
Azo dye formation Positive
Purity 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

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