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
Definition Anthocyanins are obtained by maceration or extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the strains of vegetables and edible fruits, with subsequent concentration and/or purification if necessary. The resulting product can be transformed into powder by an industrial drying process. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material. Ethanol may naturally be present as a result of the maceration process. The colouring principle is anthocyanin. Products are marketed according to their colour strength as determined by the assay. Colour content is not expressed using quantitative units. Anthocyanins are obtained by maceration or extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the strains of vegetables and edible fruits, with subsequent concentration and/or purification if necessary. The resulting product can be transformed into powder by an industrial drying process. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material. Ethanol may naturally be present as a result of the maceration process. The colouring principle is anthocyanin. Products are marketed according to their colour strength as determined by the assay. Colour content is not expressed using quantitative units.
Colour Index No
Einecs 208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin); 215-849-4 (petunidin) 208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin); 215-849-4 (petunidin)
Chemical name 3,3′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin) 3,4′,5,7-Tetrahydroxy-3′-methoxyflavylium chloride (peonidin) 3,4′,5,7-Tetrahydroxy-3′,5′-dimethoxyflavylium chloride (malvidin) 3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium chloride (delphinidin) 3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin) 3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pelargonidin) 3,3′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin) 3,4′,5,7-Tetrahydroxy-3′-methoxyflavylium chloride (peonidin) 3,4′,5,7-Tetrahydroxy-3′,5′-dimethoxyflavylium chloride (malvidin) 3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium chloride (delphinidin) 3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin) 3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pelargonidin)
Chemical formula Cyanidin: C15H11O6Cl Peonidin: C16H13O6Cl Malvidin: C17H15O7Cl Delphinidin: C15H11O7Cl Petunidin: C16H13O7Cl Pelargonidin: C15H11O5Cl Cyanidin: C15H11O6Cl Peonidin: C16H13O6Cl Malvidin: C17H15O7Cl Delphinidin: C15H11O7Cl Petunidin: C16H13O7Cl Pelargonidin: C15H11O5Cl
Molecular weight Cyanidin: 322,6 Peonidin: 336,7 Malvidin: 366,7 Delphinidin: 340,6 Petunidin: 352,7 Pelargonidin: 306,7 Cyanidin: 322,6 Peonidin: 336,7 Malvidin: 366,7 Delphinidin: 340,6 Petunidin: 352,7 Pelargonidin: 306,7
Assay Image omitted; see official source 300 for the pure pigment at 515-535 nm at pH 3,0 Image omitted; see official source 300 for the pure pigment at 515-535 nm at pH 3,0
Description Purplish-red liquid, powder or paste, having a slight characteristic odour Purplish-red liquid, powder or paste, having a slight characteristic odour
Identification Identification Identification
Spectrometry Maximum in methanol with 0,01 % conc. HCl Cyanidin: 535 nm Peonidin: 532 nm Malvidin: 542 nm Delphinidin: 546 nm Petunidin: 543 nm Pelargonidin: 530 nm Maximum in methanol with 0,01 % conc. HCl Cyanidin: 535 nm Peonidin: 532 nm Malvidin: 542 nm Delphinidin: 546 nm Petunidin: 543 nm Pelargonidin: 530 nm
Purity Purity Purity
Solvent residues Methanol Not more than 50 mg/kg
Solvent residues Ethanol Not more than 200 mg/kg
Sulfur dioxide Not more than 1 000  mg/kg per percent pigment Not more than 1 000  mg/kg per percent pigment
Arsenic Not more than 3 mg/kg Not more than 3 mg/kg
Lead Not more than 2 mg/kg Not more than 2 mg/kg
Mercury Not more than 1 mg/kg Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 170 CALCIUM CARBONATE

Synonyms CI Pigment White 18; Chalk
Definition Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.
Colour Index No 77220
Einecs Calcium carbonate: 207-439-9 Limestone: 215-279-6
Chemical name Calcium carbonate
Chemical formula CaCO3
Molecular weight 100,1
Assay Content not less than 98 % on the anhydrous basis
Description White crystalline or amorphous, odourless and tasteless powder
Identification Identification
Solubility Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium.
Purity Purity
Loss on drying Not more than 2,0 % (200 °C, 4 hours)
Acid-insoluble substances Not more than 0,2 %
Magnesium and alkali salts Not more than 1 %
Fluoride Not more than 50 mg/kg
Antimony (as Sb) Image omitted; see official source Not more than 100 mg/kg, singly or in combination
Copper (as Cu) Image omitted; see official source Not more than 100 mg/kg, singly or in combination
Chromium (as Cr) Image omitted; see official source Not more than 100 mg/kg, singly or in combination
Zinc (as Zn) Image omitted; see official source Not more than 100 mg/kg, singly or in combination
Barium (as Ba) Image omitted; see official source Not more than 100 mg/kg, singly or in combination
Arsenic Not more than 3 mg/kg
Lead Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg

E 171 TITANIUM DIOXIDE

Synonyms CI Pigment White 6
Definition Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product. The anatase grades of pigmentary titanium dioxide can only be made by the sulphate process which creates a large amount of sulphuric acid as a by-product. The rutile grades of titanium dioxide are typically made by the chloride process. Certain rutile grades of titanium dioxide are produced using mica (also known as potassium aluminum silicate) as a template to form the basic platelet structure. The surface of the mica is coated with titanium dioxide using a specialised patented process. Rutile titanium dioxide, platelet form is manufactured by subjecting titanium dioxide (rutile) coated mica nacreous pigment to an extractive dissolution in acid followed by an extractive dissolution in alkali. All of the mica is removed during this process and the resulting product is a platelet form of rutile titanium dioxide.
Colour Index No 77891
Einecs 236-675-5
Chemical name Titanium dioxide
Chemical formula TiO2
Molecular weight 79,88
Assay Content not less than 99 % on an alumina and silica-free basis
Description White to slightly coloured powder
Identification Identification
Solubility Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulphuric acid.
Purity Purity
Loss on drying Not more than 0,5 % (105 °C, 3 hours)
Loss on ignition Not more than 1,0 % on a volatile matter free basis (800 °C)
Aluminium oxide and/or silicon dioxide Total not more than 2,0 %
Matter soluble in 0,5 N HCl Not more than 0,5 % on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold.
Water soluble matter Not more than 0,5 %
Cadmium Not more than 1 mg/kg after an extraction with 0,5 N HCl.
Antimony Not more than 2 mg/kg after an extraction with 0,5 N HCl.
Arsenic Not more than 1 mg/kg after an extraction with 0,5 N HCl.
Lead Not more than 10 mg/kg after an extraction with 0,5 N HCl.
Mercury Not more than 1 mg/kg after an extraction with 0,5 N HCl.

E 172 IRON OXIDES AND IRON HYDROXIDES

Synonyms Iron Oxide Yellow: CI Pigment Yellow 42 and 43 Iron Oxide Yellow: CI Pigment Yellow 42 and 43
Synonyms Iron Oxide Red: CI Pigment Red 101 and 102 Iron Oxide Red: CI Pigment Red 101 and 102
Synonyms Iron Oxide Black: CI Pigment Black 11 Iron Oxide Black: CI Pigment Black 11
Synonyms Definition Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process. Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process.
Colour Index No Iron Oxide Yellow: 77492
Colour Index No Iron Oxide Red: 77491
Colour Index No Iron Oxide Black: 77499
Einecs Iron Oxide Yellow: 257-098-5
Einecs Iron Oxide Red: 215-168-2
Einecs Iron Oxide Black: 235-442-5
Chemical name Iron Oxide Yellow: hydrated ferric oxide, hydrated iron (III) oxide Iron Oxide Yellow: hydrated ferric oxide, hydrated iron (III) oxide
Chemical name Iron Oxide Red: anhydrous ferric oxide, anhydrous iron (III) oxide Iron Oxide Red: anhydrous ferric oxide, anhydrous iron (III) oxide
Chemical name Iron Oxide Black: ferroso ferric oxide, iron (II, III) oxide Iron Oxide Black: ferroso ferric oxide, iron (II, III) oxide
Chemical formula Iron Oxide Yellow: FeO(OH) · H2O
Chemical formula Iron Oxide Red: Fe2O3
Chemical formula Iron Oxide Black: FeO.Fe2O3
Molecular weight 88,85: FeO(OH)
Molecular weight 159,70: Fe2O3
Molecular weight 231,55: FeO.Fe2O3
Assay Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron
Description Powder; yellow, red, brown or black in hue Powder; yellow, red, brown or black in hue
Identification Identification Identification
Solubility Insoluble in water and in organic solvents Soluble in concentrated mineral acids Insoluble in water and in organic solvents Soluble in concentrated mineral acids
Purity Purity Purity
Water soluble matter Not more than 1,0 % Image omitted; see official source By total dissolution
Arsenic Not more than 3 mg/kg Image omitted; see official source By total dissolution
Cadmium Not more than 1 mg/kg Image omitted; see official source By total dissolution
Chromium Not more than 100 mg/kg Image omitted; see official source By total dissolution
Copper Not more than 50 mg/kg Image omitted; see official source By total dissolution
Lead Not more than 10 mg/kg Image omitted; see official source By total dissolution
Mercury Not more than 1 mg/kg Image omitted; see official source By total dissolution
Nickel Not more than 200 mg/kg Image omitted; see official source By total dissolution
Zinc Not more than 100 mg/kg Image omitted; see official source By total dissolution

E 173 ALUMINIUM

Synonyms CI Pigment Metal
Definition Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids.
Colour Index No 77000
Einecs 231-072-3
Chemical name Aluminium
Chemical formula Al
Atomic weight 26,98
Assay Not less than 99 % calculated as Al on an oil-free basis
Description A silvery-grey powder or tiny sheets
Identification Identification
Solubility Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid.
Test for aluminium A sample dissolved in dilute hydrochloric acid passes test
Purity Purity
Loss on drying Not more than 0,5 % (105 °C, to constant weight)
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg

E 174 SILVER

Synonyms Argentum
Definition Definition
Colour Index No 77820
Einecs 231-131-3
Chemical name Silver
Chemical formula Ag
Atomic weight 107,87
Assay Content not less than 99,5 % Ag
Description Silver-coloured powder or tiny sheets
Identification
Purity

E 175 GOLD

Synonyms Pigment Metal 3; Aurum Pigment Metal 3; Aurum
Definition Definition Definition
Colour Index No 77480 77480
Einecs 231-165-9 231-165-9
Chemical name Gold Gold
Chemical formula Au Au
Atomic weight 197,0 197,0
Assay Content not less than 90 % Au Content not less than 90 % Au
Description Gold-coloured powder or tiny sheets Gold-coloured powder or tiny sheets
Identification
Purity Purity Purity
Silver Not more than 7 % Image omitted; see official source After complete dissolution
Copper Not more than 4 % Image omitted; see official source After complete dissolution

E 180 LITHOLRUBINE BK

Synonyms CI Pigment Red 57; Rubinpigment; Carmine 6B
Definition Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulphate as the principal uncoloured components.
Colour Index No 15850:1
Einecs 226-109-5
Chemical name Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylate
Chemical formula C18H12CaN2O6S
Molecular weight 424,45
Assay Content not less than 90 % total colouring matters Image omitted; see official source 200 at ca. 442 nm in dimethylformamide
Description Red powder
Identification Identification
Spectrometry Maximum in dimethylformamide at ca. 442 nm
Purity Purity
Subsidiary colouring matters Not more than 0,5 %
Organic compounds other than colouring matters:
2-Amino-5-methylbenzenesulfonic acid, calcium salt Not more than 0,2 %
3-hydroxy-2-naphthalenecarboxylic acid, calcium salt Not more than 0,4 %
Unsulfonated primary aromatic amines Not more than 0,01 % (expressed as aniline)
Ether extractable matter From a solution of pH 7, not more than 0,2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 200 SORBIC ACID

Synonyms
Definition Definition
Einecs 203-768-7
Chemical name Sorbic acid; trans, trans-2,4-Hexadienoic acid
Chemical formula C6H8O2
Molecular weight 112,12
Assay Content not less than 99 % on the anhydrous basis
Description Colourless needles or white free flowing crystalline powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 °C
Identification Identification
Melting range Between 133 °C and 135 °C, after vacuum drying for four hours in a sulphuric acid desiccator
Spectrometry A propan-2-ol solution (1 in 4 000 000 ) shows absorbance maximum at 254 ± 2 nm
Test for double bonds Passes test
Solubility Slightly soluble in water, soluble in ethanol.
Purity Purity
Water content Not more than 0,5 % (Karl Fischer method)
Sulphated ash Not more than 0,2 %
Aldehydes Not more than 0,1 % (as formaldehyde)
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,01 mg/kg
Zinc Not more than 0,1 mg/kg

E 202 POTASSIUM SORBATE

Synonyms
Definition Definition
Einecs 246-376-1
Chemical name Potassium sorbate; Potassium (E,E)-2,4-hexadienoate; Potassium salt of trans, trans 2,4-hexadienoic acid
Chemical formula C6H7O2K
Molecular weight 150,22
Assay Content not less than 99 % on the dried basis
Description White crystalline powder or granules showing no change in colour after heating for 90 minutes at 105 °C
Identification Identification
Melting range for sorbic acid Melting range of sorbic acid isolated by acidification and not recrystallised 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator
Test for potassium Passes test
Test for double bonds Passes test
Purity Purity
Loss on drying Not more than 1,0 % (105 °C, 3 hours)
Acidity or alkalinity Not more than about 1,0 % (as sorbic acid or K2CO3)
Aldehydes Not more than 0,1 %, calculated as formaldehyde
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,01 mg/kg
Zinc Not more than 0,1 mg/kg

E 210 BENZOIC ACID

Synonyms
Definition Definition
Einecs 200-618-2
Chemical name Benzoic acid; Benzenecarboxylic acid; Phenylcarboxylic acid
Chemical formula C7H6O2
Molecular weight 122,12
Assay Content not less than 99,5 % on the anhydrous basis
Description White crystalline powder
Identification Identification
Melting range 121,5 °C -123,5 °C
Sublimation test Passes test
Test for benzoate Passes test
pH About 4 (solution in water)
Purity Purity
Loss on drying Not more than 0,5 % (3 hours, over sulphuric acid)
Sulphated ash Not more than 0,05 %
Chlorinated organic compounds Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid
Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonisable substances A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC [^E0011], 0,3 ml of ferric chloride TSC [^E0012], 0,1 ml of copper sulphate TSC [^E0013] and 4,4 ml of water
Polycyclic acids On fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl2·6H2O in a sufficient quantity of a mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl2·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl2·6H2O per ml.

Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl3·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of FeCl3·6H2O per ml.

Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS [^E0014]. 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO4·5H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 62,4 mg of CuSO4·5H2O per ml.

Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluable starch) with 5 ml of water; to the resulting paste add a sufficient quantity of water to give a total volume of 100 ml, stirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be freshly prepared.

E 211 SODIUM BENZOATE

Synonyms
Definition Definition
Einecs 208-534-8
Chemical name Sodium benzoate; Sodium salt of benzenecarboxylic acid; Sodium salt of phenylcarboxylic acid
Chemical formula C7H5O2Na
Molecular weight 144,11
Assay Not less than 99 % of C7H5O2Na, after drying at 105 °C for four hours
Description A white, almost odourless, crystalline powder or granules
Identification Identification
Solubility Freely soluble in water, sparingly soluble in ethanol
Melting range for benzoic acid Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after drying in a sulphuric acid desiccator
Test for benzoate Passes test
Test for sodium Passes test
Purity Purity
Loss on drying Not more than 1,5 % (105 °C, 4 hours)
Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Polycyclic acids On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid
Acidity or alkalinity Neutralisation of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 212 POTASSIUM BENZOATE

Synonyms
Definition Definition
Einecs 209-481-3
Chemical name Potassium benzoate; Potassium salt of benzenecarboxylic acid; Potassium salt of phenylcarboxylic acid
Chemical formula C7H5KO2·3H2O
Molecular weight 214,27
Assay Content not less than 99 % C7H5KO2 after drying at 105 °C to constant weight
Description White crystalline powder
Identification Identification
Melting range for benzoic acid Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator
Test for benzoate Passes test
Test for potassium Passes test
Purity Purity
Loss on drying Not more than 26,5 % (105 °C, 4 hours)
Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid
Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonisable substances A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
Acidity or alkalinity Neutralisation of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 213 CALCIUM BENZOATE

Synonyms Monocalcium benzoate Monocalcium benzoate
Definition Definition Definition
Einecs 218-235-4 218-235-4
Chemical name Calcium benzoate; Calcium dibenzoate Calcium benzoate; Calcium dibenzoate
Chemical formula Anhydrous: C14H10O4Ca
Chemical formula Monohydrate: C14H10O4Ca·H2O
Chemical formula Trihydrate: C14H10O4Ca·3H2O
Molecular weight Anhydrous: 282,31
Molecular weight Monohydrate: 300,32
Molecular weight Trihydrate: 336,36
Assay Content not less than 99 % after drying at 105 °C Content not less than 99 % after drying at 105 °C
Description White or colourless crystals, or white powder White or colourless crystals, or white powder
Identification Identification Identification
Melting range for benzoic acid Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator
Test for benzoate Passes test Passes test
Test for calcium Passes test Passes test
Purity Purity Purity
Loss on drying Not more than 17,5 % (105 °C, to constant weight) Not more than 17,5 % (105 °C, to constant weight)
Water insoluble matter Not more than 0,3 % Not more than 0,3 %
Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid
Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonisable substances Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid
Acidity or alkalinity Neutralisation of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl Neutralisation of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Fluoride Not more than 10 mg/kg Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg Not more than 3 mg/kg
Lead Not more than 2 mg/kg Not more than 2 mg/kg
Mercury Not more than 1 mg/kg Not more than 1 mg/kg

E 214 ETHYL p-HYDROXYBENZOATE

Synonyms Ethylparaben; Ethyl p-oxybenzoate
Definition Definition
Einecs 204-399-4
Chemical name Ethyl-p-hydroxybenzoate; Ethyl ester of p-hydroxybenzoic acid
Chemical formula C9H10O3
Molecular weight 166,8
Assay Content not less than 99,5 % after drying for two hours at 80 °C
Description Almost odourless, small, colourless crystals or a white, crystalline powder
Identification Identification
Melting range 115-118 °C
Test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 °C to 217 °C, after vacuum drying in a sulphuric acid desiccator
Test for alcohol Passes test
Purity Purity
Loss on drying Not more than 0,5 % (80 °C, 2 hours)
Sulphated ash Not more than 0,05 %
p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 215 SODIUM ETHYL p-HYDROXYBENZOATE

Synonyms
Definition Definition
Einecs 252-487-6
Chemical name Sodium ethyl p-hydroxybenzoate; Sodium compound of the ethyl ester of p-hydroxybenzoic acid
Chemical formula C9H9O3Na
Molecular weight 188,8
Assay Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis
Description White, crystalline hygroscopic powder
Identification Identification
Melting range 115 °C to 118 °C, after vacuum drying in a sulphuric acid desiccator
Test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C
Test for sodium Passes test
pH 9,9-10,3 (0,1 % aqueous solution)
Purity Purity
Loss on drying Not more than 5 %, (by vacuum drying in a sulphuric acid desiccator)
Sulphated ash 37 to 39 %
p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 218 METHYL p-HYDROXYBENZOATE

Synonyms Methylparaben; Methyl-p-oxybenzoate
Definition Definition
Einecs 243-171-5
Chemical name Methyl p-hydroxybenzoate; Methyl ester of p-hydroxybenzoic acid
Chemical formula C8H8O3
Molecular weight 152,15
Assay Content not less than 99 % after drying for two hours at 80 °C
Description Almost odourless, small colourless crystals or white crystalline powder
Identification Identification
Melting range 125 °C - 128 °C
Test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C after drying for two hours at 80 °C
Purity Purity
Loss on drying Not more than 0,5 % (80 °C, 2 hours)
Sulphated ash Not more than 0,05 %
p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 219 SODIUM METHYL p-HYDROXYBENZOATE

Synonyms
Definition Definition
Einecs
Chemical name Sodium methyl p-hydroxybenzoate; Sodium compound of the methylester of p-hydroxybenzoic acid
Chemical formula C8H7O3Na
Molecular weight 174,15
Assay Content not less than 99,5 % on the anhydrous basis
Description White, hygroscopic powder
Identification Identification
Melting range The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methyl p-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80 °C for two hours, have a melting range of 125 °C to 128 °C
Test for sodium Passes test
pH 9,7-10,3 (0,1 % solution in carbon dioxide free water)
Purity Purity
Water content Not more than 5 % (Karl Fischer method)
Sulphated ash 40 % to 44,5 % on the anhydrous basis
p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 220 SULPHUR DIOXIDE

Synonyms
Definition Definition
Einecs 231-195-2
Chemical name Sulphur dioxide; Sulphurous acid anhydride
Chemical formula SO2
Molecular weight 64,07
Assay Content not less than 99 %
Description Colourless, non-flammable gas with strong pungent suffocating odour
Identification Identification
Test for sulphurous substances Passes test
Purity Purity
Water content Not more than 0,05 % (Karl Fischer method)
Non-volatile residue Not more than 0,01 %
Sulphur trioxide Not more than 0,1 %
Selenium Not more than 10 mg/kg
Other gases not normally present in the air No trace
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg

E 221 SODIUM SULPHITE

Synonyms
Definition Definition Definition
Einecs 231-821-4 231-821-4
Chemical name Sodium sulphite (anhydrous or heptahydrate) Sodium sulphite (anhydrous or heptahydrate)
Chemical formula Anhydrous: Na2SO3
Chemical formula Heptahydrate: Na2SO37H2O
Molecular weight Anhydrous: 126,04
Molecular weight Heptahydrate: 252,16
Assay Anhydrous: Not less than 95 % of Na2SO3 and not less than 48 % of SO2
Assay Heptahydrate: Not less than 48 % of Na2SO3 and not less than 24 % of SO2
Description White crystalline powder or colourless crystals White crystalline powder or colourless crystals
Identification Identification Identification
Test for sulphite Passes test Passes test
Test for sodium Passes test Passes test
pH 8,5-11,5 (anhydrous: 10 % solution; heptahydrate: 20 % solution) 8,5-11,5 (anhydrous: 10 % solution; heptahydrate: 20 % solution)
Purity Purity Purity
Thiosulphate Not more than 0,1 % based on the SO2 content Not more than 0,1 % based on the SO2 content
Iron Not more than 10 mg/kg based on the SO2 content Not more than 10 mg/kg based on the SO2 content
Selenium Not more than 5 mg/kg based on the SO2 content Not more than 5 mg/kg based on the SO2 content
Arsenic Not more than 3 mg/kg Not more than 3 mg/kg
Lead Not more than 2 mg/kg Not more than 2 mg/kg
Mercury Not more than 1 mg/kg Not more than 1 mg/kg

E 222 SODIUM HYDROGEN SULPHITE

Synonyms
Definition Definition
Einecs 231-921-4
Chemical name Sodium bisulphite; Sodium hydrogen sulphite
Chemical formula NaHSO3 in aqueous solution
Molecular weight 104,06
Assay Content not less than 32 % w/w NaHSO3
Description A clear, colourless to yellow solution
Identification Identification
Test for sulphite Passes test
Test for sodium Passes test
pH 2,5-5,5 (10 % aqueous solution)
Purity Purity
Iron Not more than 10 mg/kg based on the SO2 content
Selenium Not more than 5 mg/kg based on the SO2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 223 SODIUM METABISULPHITE

Synonyms Pyrosulphite; Sodium pyrosulphite
Definition Definition
Einecs 231-673-0
Chemical name Sodium disulphite; Disodium pentaoxodisulphate
Chemical formula Na2S2O5
Molecular weight 190,11
Assay Content not less than 95 % Na2S2O5 and not less than 64 % of SO2
Description White crystals or crystalline powder
Identification Identification
Test for sulphite Passes test
Test for sodium Passes test
pH 4,0-5,5 (10 % aqueous solution)
Purity Purity
Thiosulphate Not more than 0,1 % based on the SO2 content
Iron Not more than 10 mg/kg based on the SO2 content
Selenium Not more than 5 mg/kg based on the SO2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 224 POTASSIUM METABISULPHITE

Synonyms Potassium pyrosulphite
Definition Definition
Einecs 240-795-3
Chemical name Potassium disulphite; Potassium pentaoxo disulphate
Chemical formula K2S2O5
Molecular weight 222,33
Assay Content not less than 90 % K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate
Description Colourless crystals or white crystalline powder
Identification Identification
Test for sulphite Passes test
Test for potassium Passes test
Purity Purity
Thiosulphate Not more than 0,1 % based on the SO2 content
Iron Not more than 10 mg/kg based on the SO2 content
Selenium Not more than 5 mg/kg based on the SO2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 226 CALCIUM SULPHITE

Synonyms
Definition Definition
Einecs 218-235-4
Chemical name Calcium sulphite
Chemical formula CaSO3·2H2O
Molecular weight 156,17
Assay Content not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2
Description White crystals or white crystalline powder
Identification Identification
Test for sulphite Passes test
Test for calcium Passes test
Purity Purity
Iron Not more than 10 mg/kg based on the SO2 content
Selenium Not more than 5 mg/kg based on the SO2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 227 CALCIUM HYDROGEN SULPHITE

Synonyms
Definition Definition
Einecs 237-423-7
Chemical name Calcium bisulphite; Calcium hydrogen sulphite
Chemical formula Ca(HSO3)2
Molecular weight 202,22
Assay 6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO3)2]
Description Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide
Identification Identification
Test for sulphite Passes test
Test for calcium Passes test
Purity Purity
Iron Not more than 10 mg/kg based on the SO2 content
Selenium Not more than 5 mg/kg based on the SO2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 228 POTASSIUM HYDROGEN SULPHITE

Synonyms
Definition Definition
Einecs 231-870-1
Chemical name Potassium bisulphite; Potassium hydrogen sulphite
Chemical formula KHSO3 in aqueous solution
Molecular weight 120,17
Assay Content not less than 280 g KHSO3 per litre (or 150 g SO2 per litre)
Description Clear colourless aqueous solution
Identification Identification
Test for sulphite Passes test
Test for potassium Passes test
Purity Purity
Iron Not more than 10 mg/kg based on the SO2 content
Selenium Not more than 5 mg/kg based on the SO2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 234 NISIN

Synonyms
Definition Nisin consists of several closely related polypeptides produced by strains of Lactococcus lactis subsp. lactis
Einecs 215-807-5
Chemical name
Chemical formula C143H230N42O37S7
Molecular weight 3 354,12
Assay Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 %
Description White powder
Identification
Purity Purity
Loss on drying Not more than 3 % (102 °C to 103 °C, to constant weight)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg

E 235 NATAMYCIN

Synonyms Pimaricin
Definition Natamycin is a fungicide of the polyene macrolide group, and is produced by strains of Streptomyces natalensis and other relevant species
Einecs 231-683-5
Chemical name A stereoisomer of 22-(3-Amino-3,6-dideoxy-β-D- mannopyranosyloxy)-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatricyclo[22.3.1.05,7]octacosa-8,14,16,18,20-pentaene-25-carboxylic acid.
Chemical formula C33H47O13N
Molecular weight 665,74
Assay Content not less than 95 % on the dried basis
Description White to creamy-white crystalline powder
Identification Identification
Colour reactions On adding a few crystals of natamycin on a spot plate, to a drop of: concentrated hydrochloric acid, a blue colour develops, concentrated phosphoric acid, a green colour develops,which changes into pale red after a few minutes
Spectrometry A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm
pH 5,5-7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water)
Specific rotation [α]D 20 + 250° to + 295° (a 1 % w/v solution in glacial acetic acid, at 20 °C and calculated with reference to the dried material)
Purity Purity
Loss on drying Not more than 8 % (over P2O5, in vacuum at 60 °C to constant weight)
Sulphated ash Not more than 0,5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Microbiological criteria Microbiological criteria
Total plate count Not more than 100 colonies per gram

E 239 HEXAMETHYLENE TETRAMINE

Synonyms Hexamine; Methenamine
Definition Definition
Einecs 202-905-8
Chemical name 1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine
Chemical formula C6H12N4
Molecular weight 140,19
Assay Content not less than 99 % on the anhydrous basis
Description Colourless or white crystalline powder
Identification Identification
Test for formaldehyde Passes test
Test for ammonia Passes test
Sublimation point: Approximately 260 °C
Purity Purity
Loss on drying Not more than 0,5 % (at 105 °C in vacuum over P2O5 for 2 hours)
Sulphated ash Not more than 0,05 %
Sulphates Not more than 0,005 % expressed as SO4
Chlorides Not more than 0,005 % expressed as Cl
Ammonium salts Not detectable
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 242 DIMETHYL DICARBONATE

Synonyms DMDC; Dimethyl pyrocarbonate
Definition Definition
Einecs 224-859-8
Chemical name Dimethyl dicarbonate; Pyrocarbonic acid dimethyl ester
Chemical formula C4H6O5
Molecular weight 134,09
Assay Content not less than 99,8 %
Description Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion
Identification Identification
Decomposition After dilution positive tests for CO2 and methanol
Melting point 17 °C
Boiling point 172 °C with decomposition
Density 20 °C Approximately 1,25 g/cm3
Infrared absorption spectrum Maxima at 1 156 and 1 832  cm-1
Purity Purity
Dimethyl carbonate Not more than 0,2 %
Chlorine, total Not more than 3 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 243 ETHYL LAUROYL ARGINATE

Synonyms Lauric arginate ethyl ester; lauramide arginine ethyl ester; ethyl-Να-lauroyl-L-arginate·HCl; LAE;
Definition Ethyl lauroyl arginate is synthesized by esterifying arginine with ethanol, followed by reacting the ester with lauroyl chloride, in aqueous media at a controlled temperature between 10 and 15 °C and at a pH between 6,7 and 6,9. The resultant ethyl lauroyl arginate is recovered as the hydrochloride salt, which is filtered and dried.
ELINCS 434-630-6
Chemical name Ethyl-Να-dodecanoyl-L-arginate·HCl
Chemical formula C20H41N4O3Cl
Molecular Weight 421,02
Assay Not less than 85 % and not more than 95 %
Description White powder
Identification
Solubility Freely soluble in water, ethanol, propylene glycol and glycerol
Purity
Να-Lauroyl-L-arginine Not more than 3 %
Lauric acid Not more than 5 %
Ethyl laurate Not more than 3 %
L-Arginine·HCl Not more than 1 %
Ethyl arginate·2HCl Not more than 1 %
Lead Not more than 1 mg/kg
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg

E 246 GLYCOLIPIDS

Synonyms
Definition The naturally occurring glycolipids are obtained by a fermentation process using the wild type strain MUCL 53181 of the fungus Dacryopinax spathularia (edible sweet osmanthus ear mushroom). Glucose is used as a carbon source. The solvent-free downstream process includes filtration and microfiltration to remove microbial cells, precipitation and washing with buffered water to purify. The product is pasteurized and spray-dried. The production process does not chemically modify the glycolipids or change their innate composition.
CAS number 2205009-17-0
Chemical name Glycolipids from Dacryopinax spathularia
Assay Not less than 93 % total glycolipid content on the dried basis.
Description Beige to light brown powder, weak characteristic odour
Identification
Solubility Complies (10 g/l in water)
pH Between 5,0 and 7,0 (10 g/l in water)
Turbidity Not more than 28 NTU (10 g/l in water)
Purity
Water content Not more than 5 % (Karl Fischer Method)
Protein Not more than 3 % (factor N x 6,25)
Fat Not more than 2 % (gravimetric)
Sodium Not more than 3,3 %
Arsenic Not more than 1 mg/kg
Lead Not more than 0,7 mg/kg
Cadmium Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg
Nickel Not more than 2 mg/kg
Microbiological criteria
Total aerobic count Not more than 100 colonies per gram
Yeast and moulds Not more than 10 colonies per gram
Coliforms Not more than 3 MPN per gram
Salmonella spp. Absent in 25 g

E 249 POTASSIUM NITRITE

Synonyms
Definition Definition
Einecs 231-832-4
Chemical name Potassium nitrite
Chemical formula KNO2
Molecular weight 85,11
Assay Content not less than 95 % on the anhydrous basis [^E0015]
Description White or slightly yellow, deliquescent granules
Identification Identification
Test for nitrite Passes test
Test for potassium Passes test
pH 6,0-9,0 (5 % solution)
Purity Purity
Loss on drying Not more than 3 % (4 hours, over silica gel)
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg

May only be sold in a mixture with salt or a salt substitute.

E 250 SODIUM NITRITE

Synonyms
Definition Definition
Einecs 231-555-9
Chemical name Sodium nitrite
Chemical formula NaNO2
Molecular weight 69,00
Assay Content not less than 97 % on the anhydrous basis [^E0016]
Description White crystalline powder or yellowish lumps
Identification Identification
Test for nitrite Passes test
Test for sodium Passes test
Purity Purity
Loss on drying Not more than 0,25 % (4 hours, over silica gel)
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg

May only be sold in a mixture with salt or a salt substitute.

E 251 SODIUM NITRATE

(i) SOLID SODIUM NITRATE

Synonyms Chile saltpetre; Cubic or soda nitre
Definition Definition
Einecs 231-554-3
Chemical name Sodium nitrate
Chemical formula NaNO3
Molecular weight 85,00
Assay Content not less than 99 % on the anhydrous basis
Description White crystalline, slightly hygroscopic powder
Identification Identification
Test for nitrate Passes test
Test for sodium Passes test
pH 5,5-8,3 (5 % solution)
Purity Purity
Loss on drying Not more than 2 % (105 °C, 4 hours)
Nitrites Not more than 30 mg/kg expressed as NaNO2
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg

(ii) LIQUID SODIUM NITRATE

Synonyms
Definition Liquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.
Einecs 231-554-3
Chemical name Sodium nitrate
Chemical formula NaNO3
Molecular weight 85,00
Assay Content between 33,5 % and 40,0 % of NaNO3
Description Clear colourless liquid
Identification Identification
Test for nitrate Passes test
Test for sodium Passes test
pH 1,5-3,5
Purity Purity
Free nitric acid Not more than 0,01 %
Nitrites Not more than 10 mg/kg expressed as NaNO2
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg

This specification refers to a 35 % aqueous solution.

E 252 POTASSIUM NITRATE

Synonyms Chile saltpetre; Cubic or soda nitre
Definition Definition
Einecs 231-818-8
Chemical name Potassium nitrate
Chemical formula KNO3
Molecular weight 101,11
Assay Content not less than 99 % on the anhydrous basis
Description White crystalline powder or transparent prisms having a cooling, saline, pungent taste
Identification Identification
Test for nitrate Passes test
Test for potassium Passes test
pH 4,5-8,5 (5 % solution)
Purity Purity
Loss on drying Not more than 1 % (105 °C, 4 hours)
Nitrites Not more than 20 mg/kg expressed as KNO2
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercury Not more than 0,1 mg/kg

E 260 ACETIC ACID

Synonyms
Definition Definition
Einecs 200-580-7
Chemical name Acetic acid; Ethanoic acid
Chemical formula C2H4O2
Molecular weight 60,05
Assay Content not less than 99,8 %
Description Clear, colourless liquid having a pungent, characteristic odour
Identification Identification
Boiling point 118 °C at 760 mm pressure (of mercury)
Specific gravity About 1,049
Test for acetate A one in three solution gives positive tests for acetate
Solidification point Not lower than 14,5 °C
Purity Purity
Non-volatile residue Not more than 100 mg/kg
Formic acid, formates and other oxidisable substances Not more than 1 000  mg/kg expressed as formic acid
Readily oxidisable substances Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes
Arsenic Not more than 1 mg/kg
Lead Not more than 0,5 mg/kg
Mercury Not more than 1 mg/kg

E 261 (i) POTASSIUM ACETATE

Synonyms
Definition Definition
Einecs 204-822-2
Chemical name Potassium acetate
Chemical formula C2H3O2K
Molecular weight 98,14
Assay Content not less than 99 % on the anhydrous basis
Description Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour
Identification Identification
pH 7,5-9,0 (5 % aqueous solution)
Test for acetate Passes test
Test for potassium Passes test
Purity Purity
Loss on drying Not more than 8 % (150 °C, 2 hours)
Formic acid, formates and other oxidisable substances Not more than 1 000  mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 261 (ii) POTASSIUM DIACETATE

Synonyms
Definition Potassium diacetate is a molecular compound of potassium acetate and acetic acid
Einecs 224-217-7
Chemical name Potassium hydrogen diacetate
Chemical formula C4H7KO4
Molecular weight 158,2
Assay Content 36 to 38 % of free acetic acid and 61 to 64 % of potassium acetate
Description White crystals
Identification Identification
pH 4,5-5 (10 % aqueous solution)
Test for acetate Passes test
Test for potassium Passes test
Purity Purity
Water content Not more than 1 % (Karl Fischer method)
Formic acid, formates and other oxidisable substances Not more than 1 000  mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 262 (i) SODIUM ACETATE

Synonyms
Definition Definition Definition
Einecs 204-823-8 204-823-8
Chemical name Sodium acetate Sodium acetate
Chemical formula C2H3NaO2·nH2O (n = 0 or 3) C2H3NaO2·nH2O (n = 0 or 3)
Molecular weight Anhydrous: 82,03
Molecular weight Trihydrate: 136,08
Assay Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis
Description Anhydrous: White, odourless, granular, hygroscopic powder
Description Trihydrate: Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air
Description Identification Identification Identification
Description pH 8,0-9,5 (1 % aqueous solution) 8,0-9,5 (1 % aqueous solution)
Test for acetate Passes test Passes test
Test for sodium Passes test Passes test
Purity Purity Purity
Loss on drying Anhydrous: Not more than 2 % (120 °C, 4 hours)
Loss on drying Trihydrate: Between 36 and 42 % (120 °C, 4 hours)
Formic acid, formates and other oxidisable substances Not more than 1 000  mg/kg expressed as formic acid Not more than 1 000  mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg Not more than 3 mg/kg
Lead Not more than 2 mg/kg Not more than 2 mg/kg
Mercury Not more than 1 mg/kg Not more than 1 mg/kg

E 262 (ii) SODIUM DIACETATE

Synonyms
Definition Sodium diacetate is a molecular compound of sodium acetate and acetic acid
Einecs 204-814-9
Chemical name Sodium hydrogen diacetate
Chemical formula C4H7NaO4·nH2O (n = 0 or 3)
Molecular weight 142,09 (anhydrous)
Assay Content 39 to 43 % of free acetic acid and 57 to 60 % of sodium acetate
Description White, hygroscopic crystalline solid with an acetic odour
Identification Identification
pH 4,5-5,0 (10 % aqueous solution)
Test for acetate Passes test
Test for sodium Passes test
Purity Purity
Water content Not more than 2 % (Karl Fischer method)
Formic acid, formates and other oxidisable substances Not more than 1 000  mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 263 CALCIUM ACETATE

Synonyms
Definition Definition Definition
Einecs 200-540-9 200-540-9
Chemical name Calcium acetate Calcium acetate
Chemical formula Anhydrous: C4H6O4Ca
Chemical formula Monohydrate: C4H6O4Ca·H2O
Molecular weight Anhydrous: 158,17
Molecular weight Monohydrate: 176,18
Assay Content not less than 98 % on the anhydrous basis Content not less than 98 % on the anhydrous basis
Description Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder
Identification Identification Identification
pH 6,0-9,0 (10 % aqueous solution) 6,0-9,0 (10 % aqueous solution)
Test for acetate Passes test Passes test
Test for calcium Passes test Passes test
Purity Purity Purity
Loss on drying Not more than 11 % (155 °C to constant weight, for the monohydrate) Not more than 11 % (155 °C to constant weight, for the monohydrate)
Water insoluble matter Not more than 0,3 % Not more than 0,3 %
Formic acid, formates and other oxidisable substances Not more than 1 000  mg/kg expressed as formic acid Not more than 1 000  mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg Not more than 3 mg/kg
Lead Not more than 2 mg/kg Not more than 2 mg/kg
Mercury Not more than 1 mg/kg Not more than 1 mg/kg

E 267 BUFFERED VINEGAR

Synonyms Buffered vinegar (liquid); buffered vinegar (powder)
Definition Buffered vinegar is a liquid or dried product prepared by adding buffering agents to vinegar. The buffering agents used are sodium/potassium hydroxides (E 524 to E 525) and sodium/potassium carbonates (E 500 to E 501). The vinegar is compliant with the European Standard EN 13188:2000 and is exclusively obtained from an agricultural source origin (except wood/cellulose) by double fermentation, alcoholic and acetous. The primary constituents of buffered vinegar are acetic acid and its salts.
Assay Liquid: 15–40 % (w/w) acetic acid equivalents
Assay Powder: 55–75 % (w/w) acetic acid equivalents
Assay 2 to 20 % (w/w) free acetic acid
Description Liquid: colourless to brown viscous liquid
Description Powder: white to creamy-white crystalline powder
Identification Liquid: pH 4,75–7,5
Identification Powder: pH 4,75–6,75 (10 % aqueous solution)
Purity Purity
Cations Liquid: Not more than 10 % sodium and 30 % potassium
Cations Powder: Not more than 30 % sodium and 40 % potassium
Water content Powder: Not more than 18 % (Karl Fischer Method)
Ethanol Not more than 0,5 % w/w
Arsenic Not more than 0,05 mg/kg
Lead Not more than 0,05 mg/kg
Cadmium Not more than 0,05 mg/kg
Mercury Not more than 0,05 mg/kg

E 270 LACTIC ACID

Synonyms
Definition Consists of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically. Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyses to lactic acid.
Einecs 200-018-0
Chemical name Lactic acid; 2-Hydroxypropionic acid; 1-Hydroxyethane-1-carboxylic acid
Chemical formula C3H6O3
Molecular weight 90,08
Assay Content not less than 76 %
Description Colourless or yellowish, nearly odourless, syrupy liquid to solid
Identification Identification
Test for lactate Passes test
Purity Purity
Sulphated ash Not more than 0,1 %
Chloride Not more than 0,2 %
Sulphate Not more than 0,25 %
Iron Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

Note: This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content

E 280 PROPIONIC ACID

Synonyms
Definition Definition
Einecs 201-176-3
Chemical name Propionic acid; Propanoic acid
Chemical formula C3H6O2
Molecular weight 74,08
Assay Content not less than 99,5 %
Description Colourless or slightly yellowish, oily liquid with a slightly pungent odour
Identification Identification
Melting point – 22 °C
Distillation range 138,5 °C to 142,5 °C
Purity Purity
Non-volatile residue Not more than 0,01 % when dried at 140 °C to constant weight
Aldehydes Not more than 0,1 % expressed as formaldehyde
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg

E 281 SODIUM PROPIONATE

Synonyms
Definition Definition
Einecs 205-290-4
Chemical name Sodium propionate; Sodium propanoate
Chemical formula C3H5O2Na
Molecular weight 96,06
Assay Content not less than 99 % after drying for two hours at 105 °C
Description White crystalline hygroscopic powder, or a fine white powder
Identification Identification
Test for propionate Passes test
Test for sodium Passes test
pH 7,5-10,5 (10 % aqueous solution)
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 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg

E 282 CALCIUM PROPIONATE

Synonyms
Definition Definition
Einecs 223-795-8
Chemical name Calcium propionate
Chemical formula C6H10O4Ca
Molecular weight 186,22
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 calcium Passes test
pH 6,0-9,0 (10 % aqueous solution)
Purity Purity
Loss on drying Not more than 4 % (105 °C, 2 hours)
Water insoluble matter Not more than 0,3 %
Iron Not more than 50 mg/kg
Fluoride Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg

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