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laying down specific purity criteria on food additives other than colours and sweeteners

The purity criteria referred to in Article 3 (3) (a) of Directive 89/107/EEC for food additives other than colours and sweeteners, as mentioned in Directive 95/2/EC, are set out in the Annex hereto.

The purity criteria referred to in Article 1 replace the purity criteria set out in Directives 65/66/EEC, 78/663/EEC and 78/664/EEC.

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1997. They shall immediately inform the Commission thereof.

When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

2. Products put on the market or labelled before 1 July 1997 which do not comply with this Directive may be marketed until stocks are exhausted.

This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.

E 200 SORBIC ACID
Definition
Chemical name	Sorbic acid Trans, trans-2,4-hexadienoic acid
Einecs	203-768-7
Chemical formula	C6H8O2
Molecular weight	112,12
Assay	Content not less than 99 % on the anhydrous basis
Description	Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 °C
Identification
A. Melting range	Between 133 °C and 135 °C, after vacuum drying for four hours in a sulphuric acid desiccator
B. Spectrometry	An isopropanol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm
C. Positive test for double bonds
D. Sublimation point	80 °C
Purity
Water content	Not more than 0,5 % (Karl Fischer method)
Sulphated ash	Not more than 0,2 %
Aldehydes	Not more than 0,1 % (as formaldehyde)
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 202 POTASSIUM SORBATE
Definition
Chemical name	Potassium sorbate Potassium (E,E)-2,4-hexadienoate Potassium salt of trans, trans 2,4-hexadienoic acid
Einecs	246-376-1
Chemical formula	C6H7O2K
Molecular weight	150,22
Assay	Content not less than 99 % on the dried basis
Description	White crystalline powder showing no change in colour after heating for 90 minutes at 105 °C
Identification
A. Melting range of sorbic acid isolated by acidification and not recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator
B. Positive tests for potassium and for double bonds
Purity
Loss on drying	Not more than 1,0 % (105 °C, 3h)
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 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 203 CALCIUM SORBATE
Definition
Chemical name	Calcium sorbate Calcium salts of trans, trans-2,4-hexadienoic acid
Einecs	231-321-6
Chemical formula	C12H14O4Ca
Molecular weight	262,32
Assay	Content not less than 98 % on the dried basis
Description	Fine white crystalline powder not showing any change in colour after heating at 105 °C for 90 minutes
Identification
A. Melting range of sorbic acid isolated by acidification and not recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator
B. Positive tests for calcium and for double bonds
Purity
Loss on drying	Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator
Aldehydes	Not more than 0,1 % (as formaldehyde)
Fluoride	Not more than 10 mg/kg
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 210 BENZOIC ACID
Definition
Chemical name	Benzoic acid Benzenecarboxylic acid Phenylcarboxylic acid
Einecs	200-618-2
Chemical formula	C7H6O2
Molecular weight	122,12
Assay	Content not less than 99,5 % on the anhydrous basis
Description	White crystalline powder
Identification
A. Melting range	121,5 °C to 123,5 °C
B. Positive sublimation test and test for benzoate
Purity
Loss on drying	Not more than 0,5 % after drying for three hours over sulphuric acid
pH	About 4 (solution in water)
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 oxidizable 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 carbonizable substances	A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC (1), 0,3 ml of ferric chloride TSC (2), 0,1 ml of copper sulphate TSC (3) and 4,4 ml of water
Polycyclic acids	On fractional acidification of a neutralized 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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 211 SODIUM BENZOATE
Definition
Chemical name	Sodium benzoate Sodium salt of benzenecarboxylic acid Sodium salt of phenylcarboxylic acid
Einecs	208-534-8
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
A. Solubility	Freely soluble in water, sparingly soluble in ethanol
B. Melting range for benzoic acid	Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after drying in a sulphuric acid desiccator
C. Positive tests for benzoate and for sodium
Purity
Loss on drying	Not more than 1,5 % after drying at 105 °C for four hours
Readily oxidizable 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 (neutralized) 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
Degree of acidity or alkalinity	Neutralization of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 212 POTASSIUM BENZOATE
Definition
Chemical name	Potassium benzoate Potassium salt of benzenecarboxylic acid Potassium salt of phenylcarboxylic acid
Einecs	209-481-3
Chemical formula	C7H5KO2·3H2O
Molecular weight	214,27
Assay	Content not less than 99 % C7H5O2K after drying at 105 °C to constant weight
Description	White crystalline powder
Identification
A. Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator
B. Positive tests for benzoate and for potassium
Purity
Loss on drying	Not more than 26,5 %, determined by drying at 105 °C
Chlorinated organic compounds	Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid
Readily oxidizable 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 carbonizable substances	A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids	On fractional acidification of a (neutralized) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
Degree of acidity or alkalinity	Neutralization of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 213 CALCIUM BENZOATE
Synonyms	Monocalcium benzoate
Definition
Chemical name	Calcium benzoate Calcium dibenzoate
Einecs	218-235-4
Chemical formula	Anhydrous:	C14H10O4Ca
	Monohydrate:	C14H10O4Ca·H2O
	Trihydrate:	C14H10O4CA·3H2O
Molecular weight	Anhydrous:	282,31
	Monohydrate:	300,32
	Trihydrate:	336,36
Assay	Content not less than 99 % after drying at 105 °C
Description	White or colourless crystals, or white powder
Identification
A. Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator
B. Positive tests for benzoate and for calcium
Purity
Loss on drying	Not more than 17,5 % determined by drying at 105 °C to constant weight
Water insoluble matter	Not more than 0,3 %
Chlorinated organic compounds	Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acids
Readily oxidizable 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 carbonizable substances	Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids	On fractional acidification of a (neutralized) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid
Degree of acidity or alkalinity	Neutralization of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Fluoride	Not more than 10 mg/kg
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 214 ETHYL p-HYDROXYBENZOATE
Synonyms	Ethylparaben Ethyl p-oxybenzoate
Definition
Chemical name	Ethyl-p-hydroxybenzoate Ethyl ester of p-hydroxybenzoic acid
Einecs	204-399-4
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
A. Melting range	115 °C to 118 °C
B. Positive test for p-hydroxybenzoate	Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallized: 213 °C to 217 °C, after vacuum drying in a sulphuric acid desiccator
C. Positive test for alcohol
Purity
Loss on drying	Not more than 0,5 % after drying for two hours at 80 °C
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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 215 SODIUM ETHYL p-HYDROXYBENZOATE
Definition
Chemical name	Sodium ethyl p-hydroxybenzoate Sodium compound of the ethyl ester of p-hydroxybenzoic acid
Einecs	252-487-6
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
A. Melting range	115 °C to 118 °C, after vacuum drying in a sulphuric acid desiccator
B. Positive test for p-hydroxybenzoate	Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C
C. Positive test for sodium
D. pH of a 0,1 % aqueous solution must be between 9,9 and 10,3
Purity
Loss on drying	Not more than 5 %, determined 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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
▼M7 —————
▼B
E 218 METHYL p-HYDROXYBENZOATE
Synonyms	Methylparaben Methyl-p-oxybenzoate
Definition
Chemical name	Methyl p-hydroxybenzoate Methyl ester of p-hydroxybenzoic acid
Einecs	243-171-5
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
A. Melting range	125 °C to 128 °C
B. Positive test for p-hydroxybenzoate	Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C after drying for two hours at 80 °C
Purity
Loss on drying	Not more than 0,5 %, after drying for two hours at 80 °C
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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 219 SODIUM METHYL p-HYDROXYBENZOATE
Definition
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
A. 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
B. Positive test for sodium
C. pH of a 0,1 % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3
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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 220 SULPHUR DIOXIDE
Definition
Chemical name	Sulphur dioxide Sulphurous acid anhydride
Einecs	231-195-2
Chemical formula	SO2
Molecular weight	64,07
Assay	Content not less than 99 %
Description	Colourless, non-flammable gas with strong pungent suffocating odour
Identification
A. Positive test for sulphurous substances
Purity
Water content	Not more than 0,05 %
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
Heavy metals (as Pb)	Not more than 10 mg/kg
E 221 SODIUM SULPHITE
Definition
Chemical name	Sodium sulphite (anhydrous or heptahydrate)
Einecs	231-821-4
Chemical formula	Anhydrous:	Na2SO3
	Heptahydrate:	Na2SO37H2O
Molecular weight	Anhydrous:	126,04
	Heptahydrate:	252,16
Assay	Anhydrous:	Not less than 95 % of Na2SO3 and not less than 48 % of SO2
	Heptahydrate:	Not less than 48 % of Na2SO3 and not less than 24 % of SO2
Description	White crystalline powder or colourless crystals
Identification
A. Positive tests for sulphite and for sodium
B. pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5
Purity
Thiosulphate	Not more than 0,1 % based on the SO2 content
Iron	Not more than 50 mg/kg based on the SO2 content
Selenium	Not more than 10 mg/kg based on the SO2 content
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 222 SODIUM BISULPHITE
Definition
Chemical name	Sodium bisulphite Sodium hydrogen sulphite
Einecs	231-921-4
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
A. Positive tests for sulphite and for sodium
B. pH of a 10 % aqueous solution between 2,5 and 5,5
Purity
Iron	Not more than 50 mg/kg of Na2SO3 based on the SO2 content
Selenium	Not more than 10 mg/kg based on the SO2 content
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 223 SODIUM METABISULPHITE
Synonyms	Pyrosulphite Sodium pyrosulphite
Definition
Chemical name	Sodium disulphite Disodium pentaoxodisulphate
Einecs	231-673-0
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
A. Positive tests for sulphite and for sodium
B. pH of a 10 % aqueous solution between 4,0 and 5,5
Purity
Thiosulphate	Not more than 0,1 % based on the SO2 content
Iron	Not more than 50 mg/kg based on the SO2 content
Selenium	Not more than 10 mg/kg based on the SO2 content
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 224 POTASSIUM METABISULPHITE
Synonyms	Potassium pyrosulphite
Definition
Chemical name	Potassium disulphite Potassium pentaoxo disulphate
Einecs	240-795-3
Chemical formula	K2S2O5
Molecular weight	222,33
Assay	Content not less than 90 % of 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
A. Positive tests for sulphite and for potassium
Purity
Thiosulphate	Not more than 0,1 % based on the SO2 content
Iron	Not more than 50 mg/kg based on the SO2 content
Selenium	Not more than 10 mg/kg based on the SO2 content
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 226 CALCIUM SULPHITE
Definition
Chemical name	Calcium sulphite
Einecs	218-235-4
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
A. Positive tests for sulphite and for calcium
Purity
Iron	Not more than 50 mg/kg based on the SO2 content
Selenium	Not more than 10 mg/kg based on the SO2 content
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 227 CALCIUM BISULPHITE
Definition
Chemical name	Calcium bisulphite Calcium hydrogen sulphite
Einecs	237-423-7
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
A. Positive tests for sulphite and for calcium
Purity
Iron	Not more than 50 mg/kg based on the SO2 content
Selenium	Not more than 10 mg/kg based on the SO2 content
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 228 POTASSIUM BISULPHITE
Definition
Chemical name	Potassium bisulphite Potassium hydrogen sulphite
Einecs	231-870-1
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
A. Positive tests for sulphite and for potassium
Purity
Iron	Not more than 50 mg/kg based on the SO2 content
Selenium	Not more than 10 mg/kg based on the SO2 content
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 230 BIPHENYL
Synonyms	Diphenyl
Definition
Chemical name	1,1′-biphenyl Phenylbenzene
Einecs	202-163-5
Chemical formula	C12H10
Molecular weight	154,20
Assay	Content not less than 99,8 %
Description	White or pale yellow to amber crystalline solid having a characteristic odour
Identification
A. Melting range	68,5 °C to 70,5 °C
B. Distillation range	It distils completely within a 2,5 °C range between 252,5 °C and 257,5 °C
Purity
Benzene	Not more than 10 mg/kg
Aromatic amines	Not more than 2 mg/kg (as aniline)
Phenol derivatives	Not more than 5 mg/kg (as phenol)
Readily carbonizable substances	Cold solution of 0,5 g of biphenyl 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
Terphenyl and higher polyphenyl derivatives	Not more than 0,2 %
Polycyclic aromatic hydrocarbons	Absent
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 231 ORTHOPHENYLPHENOL
Synonyms	Orthoxenol
Definition
Chemical name	(1,1'-Biphenyl)-2-ol 2-Hydroxydiphenyl o-Hydroxydiphenyl
Einecs	201-993-5
Chemical formula	C12H10O
Molecular weight	170,20
Assay	Content not less than 99 %
Description	White or slightly yellowish crystalline powder
Identification
A. Melting range	56 °C to 58 °C
B. Positive test for phenolate	An ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solution
Purity
Sulphated ash	Not more than 0,05 %
Diphenyl ether	Not more than 0,3 %
p-Phenylphenol	Not more than 0,1 %
1-Naphthol	Not more than 0,01 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 232 SODIUM ORTHOPHENYLPHENOL
Synonyms	Sodium orthophenylphenate Sodium salt of o-phenylphenol
Definition
Chemical name	Sodium orthophenylphenol
Einecs	205-055-6
Chemical formula	C12H9ONa·4H2O
Molecular weight	264,26
Assay	Content not less than 97 % of C12H9ONa·4H2O
Description	White or slightly yellowish crystalline powder
Identification
A. Positive tests for phenolate and for sodium
B. Melting range of orthophenylphenol isolated by acidification and not recrystallized derived from the sample 56 °C to 58 °C after drying in a sulphuric acid desiccator
C. pH of a 2 % aqueous solution must be between 11,1 and 11,8
Purity
Diphenylether	Not more than 0,3 %
p-phenylphenol	Not more than 0,1 %
1-naphthol	Not more than 0,01 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 233 THIABENDAZOLE
Definition
Chemical name	4-(2-benzimidazolyl)thiazole 2-(4-thiazolyl)-1H-benzimidazole
Einecs	1205-725-8
Chemical formula	C10H7N3S
Molecular weight	201,26
Assay	Content not less than 98 % on the anhydrous basis
Description	White, or almost white, odourless powder
Identification
A. Melting range	296 °C to 303 °C
B. Spectrometry	Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nm at 302 nm ± 2 nm: approximately 1 230 at 258 nm ± 2 nm: approximately 200 at 243 nm ± 2 nm: approximately 620 Ratio of absorption 243 nm/302 nm = 0,47 to 0,53 Ratio of absorption 258 nm/302 nm = 0,14 to 0,18
Purity
Water content	Not more than 0,5 % (Karl Fischer method)
Sulphated ash	Not more than 0,2 %
Selenium	Not more than 3 mg/kg
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 234 NISIN
Definition	Nisin consists of several closely related polypeptides produced by natural strains of Streptococcus lactis, Lancefield group N
Einecs	215-807-5
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
Purity
Loss on drying	Not more than 3 % when dried to constant weight at 102 °C to 103 °C
Arsenic	Not more than 1 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 235 NATAMYCIN
Synonyms	Pimaricin
Definition	Natamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis
Einecs	231-683-5
Chemical formula	C33H47O13N
Molecular weight	665,74
Assay	Content not less than 95 % on the anhydrous basis
Description	White to creamy-white crystalline powder
Identification
A. 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
B. 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
C. pH	5,5 to 7,5 (1 % w/v solution in previously neutralized mixture of 20 parts dimethylformamide and 80 parts of water)
D. Specific rotation	= + 250 °to + 295 ° (a 1 % w/v solution in glacial acetic acid, at 20 °C and calculated with reference to the dried material)
Purity
Loss on drying	Not more than 8 % (over 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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
Microbiological criteria: total viable count	Not more than 100/g
E 239 HEXAMETHYLENE TETRAMINE
Synonyms	Hexamine Methenamine
Definition
Chemical name	1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine
Einecs	202-905-8
Chemical formula	C6H12N4
Molecular weight	140,19
Assay	Content not less than 99 % on the anhydrous basis
Description	Colourless or white crystalline powder
Identification
A. Positive tests for formaldehyde and for ammonia
B. Sublimation point approximately 260 °C
Purity
Loss on drying	Not more than 0,5 % after drying at 105 °C in vacuum over P2O5 for two 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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 242 DIMETHYL DICARBONATE
Synonyms	DMDC Dimethyl pyrocarbonate
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
A. Decomposition	After dilution positive tests for CO2 and methanol
B. Melting point Boiling point	17 °C 172 °C with decomposition
C. Density 20 °C	Approximately 1,25 g/cm3
D. Infrared spectrum	Maxima at 1 156 and 1 832 cm- 1
Purity
Dimethyl carbonate	Not more than 0,2 %
Chlorine, total	Not more than 3 mg/kg
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 249 POTASSIUM NITRITE
Definition
Chemical name	Potassium nitrite
Einecs	231-832-4
Chemical formula	KNO2
Molecular weight	85,11
Assay	Content not less than 95 % on the anhydrous basis (5)
Description	White or slightly yellow, deliquescent granules
Identification
A. Positive tests for nitrite and for potassium
B. pH of a 5 % solution: not less than 6,0 and not more than 9,0
Purity
Loss on drying	Not more than 3 % after drying for four hours over silica gel
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 250 SODIUM NITRITE
Definition
Chemical name	Sodium nitrite
Einecs	231-555-9
Chemical formula	NaNO2
Molecular weight	69,00
Assay	Content not less than 97 % on the anhydrous basis (5)
Description	White crystalline powder or yellowish lumps
Identification
A. Positive tests for nitrite and for sodium
Purity
Loss on drying	Not more than 0,25 % after drying over silica gel for four hours
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
▼M5
E 251 SODIUM NITRATE
1. SOLID SODIUM NITRATE
Synonyms	Chile saltpetre
	Cubic or soda nitre
Definition
Chemical name	Sodium nitrate
EINECS	231-554-3
Chemical formula	NaNO3
Molecular weight	85,00
Assay	Content not less than 99 % after drying
Description	White crystalline, slightly hygroscopic powder
Identification
A. Positive tests for nitrate and for sodium
B. pH of a 5 % solution	Not less than 5,5 and not more than 8,3
Purity
Loss on drying	Not more than 2 % after drying at 105 °C for four hours
Nitrites	Not more than 30 mg/kg expressed as NaNO2
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
E 251 SODIUM NITRATE
2. LIQUID SODIUM NITRATE
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.
Chemical name	Sodium nitrate
EINECS	231-554-3
Chemical formula	NaNO3
Molecular weight	85,00
Assay	Content between 33,5 % and 40,0 % of NaNO3
Description	Clear colourless liquid
Identification
A. Positive tests for nitrate and for sodium
B. pH	Not less than 1,5 and not more than 3,5
Purity
Free nitric acid	Not more than 0,01 %
Nitrites	Not more than 10 mg/kg expressed as NaNO2
Arsenic	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 0,3 mg/kg
This specification refers to a 35 % aqueous solution.
▼B
E 252 POTASSIUM NITRATE
Synonyms	Chile saltpetre Cubic or soda nitre
Definition
Chemical name	Potassium nitrate
Einecs	231-818-8
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
A. Positive tests for nitrate and for potassium
B. pH of a 5 % solution	Not less than 4,5 and not more than 8,5
Purity
Loss on drying	Not more than 1 % after drying at 105 °C for four hours
Nitrites	Not more than 20 mg/kg expressed as KNO2
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 260 ACETIC ACID
Definition
Chemical name	Acetic acid Ethanoic acid
Einecs	200-580-7
Chemical formula	C2H4O2
Molecular weight	60,05
Assay	Content not less than 99,8 %
Description	Clear, colourless liquid having a pungent, characteristic odour
Identification
A. Boiling point	118 °C at 760 mm pressure (of mercury)
B. Specific gravity	About 1,049
C. A one in three solution gives positive tests for acetate
D. Solidification point	Not lower than 14,5 °C
Purity
Non-volatile residue	Not more than 100 mg/kg
Formic acid, formates and other oxidizable substances	Not more than 1 000 mg/kg expressed as formic acid
Readily oxidizable 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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 261 POTASSIUM ACETATE
Definition
Chemical name	Potassium acetate
Einecs	204-822-2
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
A. pH of a 5 % aqueous solution	Not less than 7,5 and not more than 9,0
B. Positive tests for acetate and for potassium
Purity
Loss on drying	Not more than 8 % after drying at 150 °C for two hours
Formic acid, formates and other oxidizable substances	Not more than 1 000 mg/kg expressed as formic acid
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 262 (i) SODIUM ACETATE
Definition
Chemical name	Sodium acetate
Einecs	204-823-8
Chemical formula	C2H3NaO2·nH2O (n = 0 or 3)
Molecular weight	Anhydrous:	82,03
	Trihydrate:	136,08
Assay	Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis
Description	Anhydrous:	White, odourless, granular, hygroscopic powder
	Trihydrate:	Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air
Identification
A. pH of a 1 % aqueous solution	Not less than 8,0 and not more than 9,5
B. Positive tests for acetate and for sodium
Purity
Loss on drying	Anhydrous:	Not more than 2 % (120 °C, 4 hours)
	Trihydrate:	Between 36 and 42 % (120 °C, 4 hours)
Formic acid, formates and other oxidizable substances	Not more than 1 000 mg/kg expressed as formic acid
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 262 (ii) SODIUM DIACETATE
Definition	Sodium diacetate is a molecular compound of sodium acetate and acetic acid
Chemical name	Sodium hydrogen diacetate
Einecs	204-814-9
Chemical formula	C4H7NaO4·nH2O (n = 0 or 3)
Molecular weight	142,09 (anhydrous)
Assay	Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate
Description	White, hygroscopic crystalline solid with an acetic odour
Identification
A. pH of a 10 % aqueous solution	Not less than 4,5 and not more than 5,0
B. Positive tests for acetate and for sodium
Purity
Water content	Not more than 2 % (Karl Fischer method)
Formic acid, formates and other oxidizable substances	Not more than 1 000 mg/kg expressed as formic acid
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 263 CALCIUM ACETATE
Definition
Chemical name	Calcium acetate
Einecs	200-540-9
Chemical formula	Anhydrous:	C4H6O4Ca
	Monohydrate:	C4H6O4Ca·H2O
Molecular weight	Anhydrous:	158,17
	Monohydrate:	176,18
Assay	Content not less than 98 % on the anhydrous basis
Description	Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder
Identification
A. pH of a 10 % aqueous solution	Not less than 6,0 and not more than 9,0
B. Positive tests for acetate and for calcium
Purity
Loss on drying	Not more than 11 % after drying (155 °C to constant weight, for the monohydrate)
Water insoluble matter	Not more than 0,3 %
Formic acid, formates and other oxidizable substances	Not more than 1 000 mg/kg expressed as formic acid
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 270 LACTIC ACID
Definition
Chemical name	Lactic acid 2-Hydroxypropionic acid 1-Hydroxyethane-1-carboxylic acid
Einecs	200-018-0
Chemical formula	C3H6O3
Molecular weight	90,08
Assay	Content not less than 76 % and not more than 84 %
Description	Colourless or yellowish, nearly odourless, syrupy liquid with an acid taste, consisting 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
Note: Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid
Identification
A. Positive test for lactate
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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 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
Definition
Chemical name	Propionic acid Propanoic acid
Einecs	201-176-3
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
Indentification
A. Melting point	- 22 °C
B. Distillation range	138,5 °C to 142,5 °C
Purity
Non-volatile residue	Not more than 0,01 % when dried at 140 °C to constant weight
Aldehydes	Not more than 0,1 % expressed as formaldehyde
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 281 SODIUM PROPIONATE
Definition
Chemical name	Sodium propionate Sodium propanoate
Einecs	205-290-4
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
A. Positive tests for propionate and for sodium
B. pH of a 10 % aqueous solution	Not less than 7,5 and not more than 10,5
Purity
Loss on drying	Not more than 4 % determined by drying for two hours at 105 °C
Water insolubles	Not more than 0,1 %
Iron	Not more than 50 mg/kg
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 282 CALCIUM PROPIONATE
Definition
Chemical name	Calcium propionate
Einecs	223-795-8
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
A. Positive tests for propionate and for calcium
B. pH of a 10 % aqueous solution	Between 6,0 and 9,0
Purity
Loss on drying	Not more than 4 %, determined by drying for two hours at 105 °C
Water insolubles	Not more than 0,3 %
Iron	Not more than 50 mg/kg
Fluoride	Not more than 10 mg/kg
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 283 POTASSIUM PROPIONATE
Definition
Chemical name	Potassium propionate Potassium propanoate
Einecs	206-323-5
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
A. Positive tests for propionate and for potassium
Purity
Loss on drying	Not more than 4 %, determined by drying for two hours at 105 °C
Water-insoluble substances	Not more than 0,3 %
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
Heavy metals (as Pb)	Not more than 10 mg/kg
E 284 BORIC ACID
Synonyms	Boracic acid Orthoboric acid Borofax
Definition
Einecs	233-139-2
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
A. Melting point	At approximately 171 °C
B. Burns with a nice green flame
C. pH of a 3,3 % aqueous solution	Between 3,8 and 4,8
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
Heavy metals (as Pb)	Not more than 10 mg/kg
E 285 SODIUM TETRABORATE (BORAX)
Synonyms	Sodium borate
Definition
Chemical name	Sodium tetraborate Sodium biborate Sodium pyroborate Anhydrous tetraborate
Einecs	215-540-4
Chemical formula	Na2B4O7 Na2B4O7·10H2O
Molecular weight	201,27
Description	Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water
Identification
A. Melting range	Between 171 °C and 175 °C with decomposition
Purity
Peroxides	No colour develops with added KI-solution
Arsenic	Not more than 1 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 290 CARBON DIOXIDE
Synonyms	Carbonic acid gas Dry ice (solid form) Carbonic anhydride
Definition
Chemical name	Carbon dioxide
Einecs	204-696-9
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 pressurized 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
A. Precipitation (Precipitate formation)	When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid
Purity
Acidity	915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)
Reducing substances, hydrogen phosphide and sulphide	915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to 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 0,1 mg/l
E 300 ASCORBIC ACID
Definition
Chemical name	L-ascorbic acid Ascorbic acid 2,3-Didehydro-L-threo-hexono-1,4-lactone 3-Keto-L-gulofuranolactone
Einecs	200-066-2
Chemical formula	C6H8O6
Molecular weight	176,13
Assay	Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6
Description	White to pale yellow, odourless crystalline solid
Identification
A. Melting range	Between 189 °C and 193 °C with decomposition
B. Positive tests for ascorbic acid
Purity
Loss on drying	Not more than 0,4 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Sulphated ash	Not more than 0,1 %
Specific rotation	between + 20,5 ° and + 21,5 ° (10 % w/v aqueous solution)
pH of a 2 % aqueous solution	Between 2,4 and 2,8
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 301 SODIUM ASCORBATE
Definition
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
Einecs	205-126-1
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 solid which darkens on exposure to light
Identification
A. Positive tests for ascorbate and for sodium
Purity
Loss on drying	Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Specific rotation	between + 103 ° and + 106 ° (10 % w/v aqueous solution)
pH of 10 % aqueous solution	Between 6,5 and 8,0
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 302 CALCIUM ASCORBATE
Definition
Chemical name	Calcium ascorbate dihydrate Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate
Einecs	227-261-5
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
A. Positive tests for ascorbate and for calcium
Purity
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Specific rotation	between + 95 ° and + 97 ° (5 % w/v aqueous solution)
pH of 10 % aqueous solution	Between 6,0 and 7,5
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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 304 (i) ASCORBYL PALMITATE
Definition
Chemical name	Ascorbyl palmitate L-ascorbyl palmitate 2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate 6-palmitoyl-3-keto-L-gulofuranolactone
Einecs	205-305-4
Chemical formula	C22H38O7
Molecular weight	414,55
Assay	Content not less than 98 % on the dried basis
Description	White or yellowish-white solid with a citrus-like odour
Identification
A. Melting range	Between 107 °C and 117 °C
Purity
Loss on drying	Not more than 2,0 % after drying in a vacuum oven at 56 °C and 60 °C for one hour
Sulphated ash	Not more than 0,1 %
Specific rotation	between + 21 °and + 24 ° (5 % w/v in methanol solution)
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 304 (ii) ASCORBYL STEARATE
Definition
Chemical name	Ascorbyl stearate L-ascorbyl stearate 2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate 6-stearoyl-3-keto-L-gulofuranolactone
Einecs	246-944-9
Chemical formula	C24H42O7
Molecular weight	442,6
Assay	Content not less than 98 %
Description	White or yellowish, white solid with a citrus-like odour
Identification
A. Melting point	About 116 °C
Purity
Loss on drying	Not more than 2,0 % after drying in a vacuum oven at 56 °C to 60 °C for one hour
Sulphated ash	Not more than 0,1 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 306 TOCOPHEROL-RICH EXTRACT
Definition	Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols Contains tocopherols such as d-α-, d-β-, d-γ- and d-ς-tocopherols
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
A. By suitable gas liquid chromatographic method
B. Solubility tests	Insoluble in water. Soluble in ethanol. Miscible in ether
Purity
Sulphated ash	Not more than 0,1 %
Specific rotation	not less than + 20 °
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
▼M7
E 307 ALPHA-TOCOPHEROL
Synonyms	DL-α-Tocopherol
Definition
Chemical name	DL-5,7,8-Trimethyltocol DL-2,5,7,8-Tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs	233-466-0
Chemical formula	C29H50O2
Molecular weight	430,71
Assay	Content not less than 96 %
Description	Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidizes and darkens on exposure to air or light
Identification
A. Solubility tests	Insoluble in water, freely soluble in ethanol, miscible in ether
B. Spectrophotometry	In absolute ethanol the maximum absorption is about 292 nm
Purity
Refractive index	n D 201,503to 1,507
Specific absorption E1 % 1 cm in ethanol	E1 % 1 cm (292 nm) 72 to 76 (0,01 g in 200 ml of absolute ethanol)
Sulphated ash	Not more than 0,1 %
Specific rotation	[α]25 D0° ± 0,05° (1 in 10 solution in chloroform)
Lead	Not more than 2 mg/kg
▼B
E 308 GAMMA-TOCOPHEROL
Synonyms	dl-γ-Tocopherol
Definition
Chemical name	2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
EINECS	231-523-4
Chemical formula	C28H48O2
Molecular weight	416,69
Assay	Content not less than 97 %
Description	Clear, viscous, pale yellow oil which oxidizes and darkens on exposure to air or light
Identification
A. Spectrometry	Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
Purity
Specific absorption in ethanol	(298 nm) between 91 and 97 (257 nm) between 5,0 and 8,0
Refractive index	1,503—1,507
Sulphated ash	Not more than 0,1 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 309 DELTA-TOCOPHEROL
Definition
Chemical name	2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs	204-299-0
Chemical formula	C27H46O2
Molecular weight	402,7
Assay	Content not less than 97 %
Description	Clear, viscous, pale yellowish or orange oil which oxidizes and darkens on exposure to air or light
Identification
A. Spectrometry	Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
Purity
Specific absorption in ethanol	(298 nm) between 89 and 95 (257 nm) between 3,0 and 6,0
Refractive index	1,500—1,504
Sulphated ash	Not more than 0,1 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 310 PROPYL GALLATE
Definition
Chemical name	Propyl gallate Propyl ester of gallic acid n-propyl ester of 3,4,5-trihydroxybenzoic acid
Einecs	204-498-2
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
A. Solubility tests	Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol
B. Melting range	Between 146 °C and 150 °C after drying at 110 °C for four hours
Purity
Loss on drying	Not more than 1,0 % (110 °C, four hours)
Sulphated ash	Not more than 0,1 %
Free acid	Not more than 0,5 % (as gallic acid)
Chlorinated organic compound	Not more than 100 mg/kg (as C1)
Specific absorption in ethanol	(275 nm) not less than 485 and not more than 520
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 311 OCTYL GALLATE
Definition
Chemical name	Octyl gallate Octyl ester of gallic acid n-octyl ester of 3,4,5-trihydroxybenzoic acid
Einecs	213-853-0
Chemical formula	C15H22O5
Molecular weight	282,34
Assay	Content not less than 98 % after drying at 90 °C for six hours
Description	White to creamy-white odourless solid
Identification
A. Solubility tests	Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol
B. Melting range	Between 99 °C and 102 °C after drying at 90 °C for six hours
Purity
Loss on drying	Not more than 0,5 % (90 °C, six hours)
Sulphated ash	Not more than 0,05 %
Free acid	Not more than 0,5 % (as gallic acid)
Chlorinated organic compound	Not more than 100 mg/kg (as C1)
Specific absorption in ethanol	(275 nm) not less than 375 and not more than 390
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 312 DODECYL GALLATE
Synonyms	Lauryl gallate
Definition
Chemical name	Dodecyl gallate n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid Dodecyl ester of gallic acid
Einecs	214-620-6
Chemical formula	C19H30O5
Molecular weight	338,45
Assay	Content not less than 98 % after drying at 90 °C for six hours
Description	White or creamy-white odourless solid
Identification
A. Solubility tests	Insoluble in water, freely soluble in ethanol and ether
B. Melting range	Between 95 °C and 98 °C after drying at 90 °C for six hours
Purity
Loss on drying	Not more than 0,5 % (90 °C, six hours)
Sulphated ash	Not more than 0,05 %
Free acid	Not more than 0,5 % (as gallic acid)
Chlorinated organic compound	Not more than 100 mg/kg (as Cl)
Specific absorption in ethanol	(275 nm) not less than 300 and not more than 325
Arsenic	Not more than 3 mg/kg
Lead	Not more than 10 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 30 mg/kg
▼M7
E 315 ERYTHORBIC ACID
Synonyms	Isoascorbic acid D-Araboascorbic acid
Definition
Chemical name	D-Erythro-hex-2-enoic acid γ-lactone Isoascorbic acid D-Isoascorbic acid
Einecs	201-928-0
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
A. Melting range	About 164 °C to 172 °C with decomposition
B. Positive test for ascorbic acid/colour reaction
Purity
Loss on drying	Not more than 0,4 % after drying under reduced pressure on silica gel for 3 hours
Sulphated ash	Not more than 0,3 %
Specific rotation	[α]25 D10 % (w/v) aqueous solution between – 16,5° to – 18,0°
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
▼B
E 316 SODIUM ERYTHORBATE
Synonyms	Sodium isoascorbate
Definition
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
Einecs	228-973-9
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
A. Solubility tests	Freely soluble in water, very slightly soluble in ethanol
B. Positive test for ascorbic acid/colour reaction
C. Positive test for sodium
Purity
Loss on drying	Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Specific rotation	10 % (w/v) aqueous solution between + 95 ° and + 98 °
pH of a 10 % aqueous solution	5,5 to 8,0
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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
▼M7
E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)
Synonyms	TBHQ
Definition
Chemical names	Tert-butyl-1,4-benzenediol 2-(1,1-Dimethylethyl)-1,4-benzenediol
Einecs	217-752-2
Chemical formula	C10H14O2
Molecular weight	166,22
Assay	Content not less than 99 % of C10H14O2
Description	White crystalline solid having a characteristic odour
Identification
A. Solubility	Practically insoluble in water; soluble in ethanol
B. Melting point	Not less than 126,5 °C
C. Phenolics	Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced
Purity
Tertiary-Butyl-p-benzoquinone	Not more than 0,2 %
2,5-Di-tertiary-butyl hydroquinone	Not more than 0,2 %
Hydroxyquinone	Not more than 0,1 %
Toluene	Not more than 25 mg/kg
Lead	Not more than 2 mg/kg
▼M2
E 320 BUTYLATED HYDROXYANISOLE (BHA)
Synonyms	BHA
Definition
Chemical names	3-Tertiary-butyl-4-hydroxyanisole A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole
EINECS	246-563-8
Chemical formula

Formula weight	180,25
Assay	Content not less than 98,5 % of and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer
Description	White or slightly yellow crystals or waxy solid with a slight aromatic smell
Identification
A. Solubility	Insoluble in water, freely soluble in ethanol
B. Melting range	Between 48 °C and 63 °C
C. Colour reaction	Passes test for phenol groups
Purity
Sulphated ash	Not more than 0,05 % after calcination at 800 ± 25 °C
Phenolic impurities	Not more than 0,5 %
Specific absorption	(290 nm) not less than 190 and not more than 210
Specific absorption	(228 nm) not less than 326 and not more than 345
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
▼B
E 321 BUTYLATED HYDROXYTOLUENE (BHT)
Synonyms	BHT
Definition
Chemical name	2,6-Ditertiary-butyl-p-cresol 4-Methyl-2,6-ditertiarybutylphenol
Einecs	204-881-4
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
A. Solubility tests	Insoluble in water and propane- 1,2-diol Freely soluble in ethanol
B. Melting point	At 70 °C
C. Absorbance maximum	The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm
Purity
Sulphated ash	Not more than 0,005 %
Phenolic impurities	Not more than 0,5 %
Specific absorption in ethanol	(278 nm) not less than 81 and not more than 88
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 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
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
A. Positive tests for choline, for phosphorus and fatty acids
B. Test for hydrolysed lecithin	To a 800 ml beaker add 500 ml of water (30 °C—35 °C). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g
Purity
Loss on drying	Not more than 2,0 % determined by drying at 105 °C for one 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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 325 SODIUM LACTATE
Definition
Chemical name	Sodium lactate Sodium 2-hydroxypropanoate
Einecs	200-772-0
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
A. Positive test for lactate
B. Positive test for potassium
Purity
Acidity	Not more than 0,5 % after drying expressed as lactic acid
pH of a 20 % aqueous solution	6,5 to 7,5
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
Reducing substances	No reduction of Fehling's solution
Note: This specification refers to a 60 % aqueous solution
E 326 POTASSIUM LACTATE
Definition
Cheminal name	Potassium lactate Potassium 2-hydroxypropanoate
Einecs	213-631-3
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
A. Ignition	Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added
B. 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
C. Positive tests for potassium and for lactate
Purity
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 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	Potassium lactate solution shall not cause any reduction of Fehling's solution
Note: This specification refers to a 60 % aqueous solution
E 327 CALCIUM LACTATE
Definition
Chemical name	Calcium dilactate Calcium dilactate hydrate 2-Hydroxypropanoic acid calcium salt
Einecs	212-406-7
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
A. Positive tests for lactate and for calcium
B. Solubility tests	Soluble in water and practically insoluble in ethanol
Purity
Loss on drying	Determined by drying at 120 °C for four hours: — anhydrous: not more than 3,0 % — with 1 molecule of water: not more than 8,0 % — with 3 molecules of water: not more than 20,0 % — with 4,5 molecules of water: not more than 27,0 %
Acidity	Not more than 0,5 % of the dry matter expressed as lactic acid
Fluoride	Not more than 30 mg/kg (expressed as fluorine)
pH of a 5 % solution	Between 6,0 and 8,0
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
Reducing substances	No reduction of Fehling's solution
E 330 CITRIC ACID
Definition
Chemical name	Citric acid 2-Hydroxy-1,2,3-propanetricarboxylic acid β-Hydroxytricarballytic acid
Einecs	201-069-1
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
A. Solubility tests	Very soluble in water; freely soluble in ethanol; soluble in ether
Purity
Water content	Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method)
Sulphated ash	Not more than 0,05 % after calcination at 800 ± 25 °C
Arsenic	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 5 mg/kg
Oxalates	Not more than 100 mg/kg, expressed as oxalic acid, after drying
Readily carbonizable 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	Monosodium citrate Monobasic sodium citrate
Definition
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
A. Positive tests for citrate and for sodium
Purity
Loss on drying	Determined by drying at 180 °C for four hours: — anhydrous: not more than 1,0 % — monohydrate: not more than 8,8 %
Oxalates	Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution	Between 3,5 and 3,8
Arsenic	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 5 mg/kg
E 331 (ii) DISODIUM CITRATE
Synonyms	Disodium citrate Dibasic sodium citrate
Definition
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
Einecs	205-623-3
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
A. Positive tests for citrate and for sodium
Purity
Loss on drying	Not more than 13,0 % by drying at 180 °C for four hours
Oxalates	Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution	Between 4,9 and 5,2
Arsenic	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 5 mg/kg
E 331 (iii) TRISODIUM CITRATE
Synonyms	Trisodium citrate Tribasic sodium citrate
Definition
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
Einecs	200-675-3
Chemical formula	Anhydrous:	C6H5O7Na3
	Hydrated:	C6H5O7Na3·nH2O (n = 2 or 5)
Molecular weight	258,07 (anhydrous)
Assay	Not less than 99 % on the anhydrous basis
Description	Crystalline white powder or colourless crystals
Identification
A. Positive tests for citrate and for sodium
Purity
Loss on drying	Determined by drying at 180 °C for four hours:
	— anhydrous:	not more than 1,0 %
	— dihydrate:	not more than 13,5 %
	— pentahydrate:	not more than 30,3 %
Oxalates	Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solution	Between 7,5 and 9,0
Arsenic	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 5 mg/kg
E 332 (i) MONOPOTASSIUM CITRATE
Synonyms	Monopotassium citrate Monobasic potassium citrate
Definition
Chemical name	Monopotassium citrate Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Anhydrous monopotassium salt of citric acid
Einecs	212-753-4
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
A. Positive tests for citrate and for potassium
Purity
Loss on drying	Not more than 1,0 % determined by drying at 180 °C for four hours
Oxalates	Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution	Between 3,5 and 3,8
Arsenic	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 5 mg/kg
E 332 (ii) TRIPOTASSIUM CITRATE
Synonyms	Tripotassium citrate Tribasic potassium citrate
Definition
Chemical name	Tripotassium citrate Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Monohydrated tripotassium salt of citric acid
Einecs	212-755-5
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
A. Positive tests for citrate and for potassium
Purity
Loss on drying	Not more than 6,0 % determined by drying at 180 °C for four hours
Oxalates	Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solution	Between 7,5 and 9,0
Arsenic	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 5 mg/kg
E 333 (i) MONOCALCIUM CITRATE
Synonyms	Monocalcium citrate Monobasic calcium citrate
Definition
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
A. Positive tests for citrate and for calcium
Purity
Loss on drying	Not more than 7,0 % determined by drying at 180 °C for four hours
Oxalates	Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution	Between 3,2 and 3,5
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
Heavy metals (as Pb)	Not more than 5 mg/kg
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	Dicalcium citrate Dibasic calcium citrate
Definition
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
A. Positive tests for citrate and for calcium
Purity
Loss on drying	Not more than 20,0 % determined by drying at 180 °C for four 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
Heavy metals (as Pb)	Not more than 5 mg/kg
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	Tricalcium citrate Tribasic calcium citrate
Definition
Chemical name	Tricalcium citrate Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Tetrahydrated tricalcium salt of citric acid
Einecs	212-391-7
Chemical formula	(C6H6O7)2Ca3·4H2O
Molecular weight	570,51
Assay	Not less than 97,5 % on the anhydrous basis
Description	Fine white powder
Identification
A. Positive tests for citrate and for calcium
Purity
Loss on drying	Not more than 14,0 % determined by drying at 180 °C for four 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
Heavy metals (as Pb)	Not more than 5 mg/kg
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
Definition
Chemical name	L-tartaric acid L-2,3-dihydroxybutanedioic acid d-α,β-dihydroxysuccinic acid
Einecs	201-766-0
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
A. Melting range	Between 168 °C and 170 °C
B. Positive test for tartrate
Purity
Loss on drying	Not more than 0,5 % (over P2O5, three hours)
Sulphated ash	Not more than 1 000 mg/kg after calcination at 800 ± 25 °C
Specific optical rotation of a 20 % w/v aqueous solution	between + 11,5 ° and + 13,5 °
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 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
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
A. Positive tests for tartrate and for sodium
Purity
Loss on drying	Not more than 10,0 % determined by drying at 105 °C for four 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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 335 (ii) DISODIUM TARTRATE
Definition
Chemical name	Disodium L-tartrate Disodium (+)-tartrate Disodium (+)-2,3-dihydroxybutanedioic acid Dihydrated disodium salt of L-(+)-tartaric acid
Einecs	212-773-3
Chemical formula	C4H4O6Na2·2H2O
Molecular weight	230,8
Assay	Content not less than 99 % on the anhydrous basis
Description	Transparent, colourless crystals
Identification
A. Positive tests for tartrate and for sodium
B. Solubility tests	1 gram is insoluble in 3 ml of water. Insoluble in ethanol
Purity
Loss on drying	Not more than 17,0 % determined by drying at 150 °C for four hours
Oxalates	Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution	Between 7,0 and 7,5
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 336 (i) MONOPOTASSIUM TARTRATE
Synonyms	Monobasic potassium tartrate
Definition
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
A. Positive tests for tartrate and for potassium
B. Melting point	230 °C
Purity
pH of a 1 % aqueous solution	3,4
Loss on drying	Not more than 1,0 % determined by drying at 105 °C for four 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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 336 (ii) DIPOTASSIUM TARTRATE
Synonyms	Dibasic potassium tartrate
Definition
Chemical name	Dipotassium salt of L-2,3-dihydroxybutanedioic acid Dipotassium salt with half a molecule of water of L-(+)-tartaric acid
Einecs	213-067-8
Chemical formula	C4H4O6K2·H2O
Molecular weight	235,2
Assay	Content not less than 99 % on the anhydrous basis
Description	White crystalline or granulated powder
Identification
A. Positive tests for tartrate and for potassium
Purity
pH of a 1 % aqueous solution	Between 7,0 and 9,0
Loss on drying	Not more than 4,0 % determined by drying at 150 °C for four 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 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 337 POTASSIUM SODIUM TARTRATE
Synonyms	Potassium sodium L-(+)-tartrate Rochelle salt Seignette salt
Definition
Chemical name	Potassium sodium salt of L-2,3-dihydroxybutanedioic acid Potassium sodium L-(+)-tartrate
Einecs	206-156-8
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
A. Positive tests for tartrate, for potassium and for sodium
B. Solubility tests	1 gram is soluble in 1 ml of water, insoluble in ethanol
C. Melting range	Between 70 and 80 °C
Purity
Loss on drying	Not more than 26,0 % and not less than 21,0 % determined by drying at 150 °C for three hours
Oxalates	Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of 1 % aqueous solution	Between 6,5 and 8,5
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
▼M4
E 338 PHOSPHORIC ACID
Synonyms	Orthophosphoric acid Monophosphoric acid
Definition
Chemical name	Phosphoric acid
Einecs	231-633-2
Chemical formula	H3PO4
Molecular weight	98,00
Assay	Phosphoric acid is commercially available as an aqueous solution at variable concentrations. Content not less than 67,0 % and not more than 85,7 %.
Description	Clear, colourless, viscous liquid
Identification
A. Positive tests for acid and for phosphate
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 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 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
Chemical name	Sodium dihydrogen monophosphate
Einecs	231-449-2
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
A. Positive tests for sodium and for phosphate
B. Solubility	Freely soluble in water. Insoluble in ethanol or ether
C. pH of a 1 % solution	Between 4,1 and 5,0
Purity
Loss on drying	The anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, and the dihydrate not more than 25 % when dried first at 60 °C for one hour, then at 105 °C for four hours
Water-insoluble substances	Not more than 0,2 % on the anhydrous basis
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 339 (ii) DISODIUM PHOSPHATE
Synonyms	Disodium monophosphate Secondary sodium phosphate Disodium orthophosphate Acid disodium phosphate
Definition
Chemical name	Disodium hydrogen monophosphate Disodium hydrogen orthophosphate
Einecs	231-448-7
Chemical formula	Anhydrous: Na2HPO4 Hydrat: 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
A. Positive tests for sodium and for phosphate
B. Solubility	Freely soluble in water. Insoluble in ethanol
C. pH of a 1 % solution	Between 8,4 and 9,6
Purity
Loss on drying	When dried at 40 °C for three hours and then at 105°C for five hours, the losses in weight are as follows: anhydrous not more than 5,0 %, dihydrate not more than 22,0 %, heptahydrate not more than 50,0 %, dodecahydrate not more than 61,0 %
Water-insoluble substances	Not more than 0,2 % on the anhydrous basis
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 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 molecule of NaOH
Chemical name	Trisodium monophosphate Trisodium phosphate Trisodium orthophosphate
Einecs	231-509-8
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
A. Positive tests for sodium and for phosphate
B. Solubility	Freely soluble in water. Insoluble in ethanol
C. pH of a 1 % solution	Between 11,5 and 12,5
Purity
Loss on ignition	When dried at 120 °C for two hours and then ignited at about 800 °C for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 %
Water insoluble substances	Not more than 0,2 % on the anhydrous basis
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 340 (i) MONOPOTASSIUM PHOSPHATE
Synonyms	Monobasic potassium phosphate Monopotassium monophosphate Potassium orthophosphate
Definition
Chemical name	Potassium dihydrogen phosphate Monopotassium dihydrogen orthophosphate Monopotassium dihydrogen monophosphate
Einecs	231-913-4
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, hygroscopic
Identification
A. Positive tests for potassium and for phosphate
B. Solubility	Freely soluble in water. Insoluble in ethanol
C. pH of a 1 % solution	Between 4,2 and 4,8
Purity
Loss on drying	Not more than 2,0 % determined by drying at 105 °C for four hours
Water-insoluble substances	Not more than 0,2 % on the anhydrous basis
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 340 (ii) DIPOTASSIUM PHOSPHATE
Synonyms	Dipotassium monophosphate Secondary potassium phosphate Dipotassium acid phosphate Dipotassium orthophosphate Dibasic potassium phosphate
Definition
Chemical name	Dipotassium hydrogen monophosphate Dipotassium hydrogen phosphate Dipotassium hydrogen orthophosphate
Einecs	231-834-5
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
Identification
A. Positive tests for potassium and for phosphate
B. Solubility	Freely soluble in water. Insoluble in ethanol
C. pH of a 1 % solution	Between 8,7 and 9,4
Purity
Loss on drying	Not more than 2,0 % determined by drying at 105 °C for four hours
Water-insoluble substances	Not more than 0,2 % on the anhydrous basis
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 340 (iii) TRIPOTASSIUM PHOSPHATE
Synonyms	Potassium phosphate Tribasic potassium phosphate Tripotassium orthophosphate
Definition
Chemical name	Tripotassium monophosphate Tripotassium phosphate Tripotassium orthophosphate
Einecs	231-907-1
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 33,0 % on the ignited basis
Description	Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate
Identification
A. Positive tests for potassium and for phosphate
B. Solubility	Freely soluble in water. Insoluble in ethanol
C. pH of a 1 % solution	Between 11,5 and 12,3
Purity
Loss on ignition	Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %. Determined by drying at 105 °C for one hour and then ignite at about 800 °C ± 25 °C for 30 minutes
Water insoluble substances	Not more than 0,2 % on the anhydrous basis
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 341 (i) MONOCALCIUM PHOSPHATE
Synonyms	Monobasic calcium phosphate Monocalcium orthophosphate
Definition
Chemical name	Calcium dihydrogen phosphate
Einecs	231-837-1
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
A. Positive tests for calcium and for phosphate
B. CaO content	Between 23,0 % and 27,5 % (anhydrous) Between 19,0 % and 24,8 % (monohydrate)
Purity
Loss on drying	Not more than 14 % determined by drying at 105 °C for four hours (anhydrous) Not more than 17,5 % determined by drying at 60 °C for one hour, then at 105 °C for four hours (monohydrate)
Loss on ignition	Not more than 17,5 % after ignition at 800 °C ± 25 °C for 30 minutes (anhydrous) Not more than 25,0 % determined by drying at 105 °C for one hour, then ignite at 800 °C ± 25 °C for 30 minutes (monohydrate)
Fluoride	Not more than 30 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 341 (ii) DICALCIUM PHOSPHATE
Synonyms	Dibasic calcium phosphate Dicalcium orthophosphate
Definition
Chemical name	Calcium monohydrogen phosphate Calcium hydrogen orthophosphate Secondary calcium phosphate
Einecs	231-826-1
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
A. Positive tests for calcium and for phosphate
B. Solubility tests	Sparingly soluble in water. Insoluble in ethanol
Purity
Loss on ignition	Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 °C ± 25 °C for 30 minutes
Fluoride	Not more than 50 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
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 and having the approximate composition of 10CaO · 3P2O5 · H2O
Chemical name	Pentacalcium hydroxy monophosphate Tricalcium monophosphate
Einecs	235-330-6 (Pentacalcium hydroxy monophosphate) 231-840-8 (Calcium orthophosphate)
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
A. Positive tests for calcium and for phosphate
B. Solubility	Practically insoluble in water; insoluble in etanol, soluble in dilute hydrochloric and nitric acid
Purity
Loss on ignition	Not more than 8 % after ignition at 800 °C ± 25 °C, to constant weight
Fluoride	Not more than 50 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
▼B
E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE
Synonyms	Calcium disodium EDTA Calcium disodium edetate
Definition
Chemical name	N,N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]calciate(2)-disodium Calcium disodium ethylenediaminetetra acetate Calcium disodium (ethylenedinitrilo)tetra acetate
Einecs	200-529-9
Chemical formula	C10H12O8CaN2Na2·2H2O
Molecular weight	410,31
Assay	Content not less than 97 % on the anhydrous basis
Description	White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic
Identification
A. Positive tests for sodium and for calcium
B. Chelating activity to metal ions positive
C. pH of a 1 % solution between 6,5 and 7,5
Purity
Water content	5 to 13 % (Karl Fischer method)
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
▼M1
Ethylene oxide may not be used for sterilising purposes in food additives
E 400 ALGINIC ACID
Definition	Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae)
Einecs	232-680-1
Chemical formula	(C6H8O6)n
Molecular weight	10 000—600 000 (typical average)
Assay	Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculted on equivalent weight basis of 200)
Description	Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless
Identification
A. Solubility	Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate
B. Calcium chloride precipitation test	To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum
C. Ammonium sulphate precipitation test	To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch
D. Colour reaction	Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple
Purity
pH of a 3 % suspension	Between 2,0 and 3,5
Loss on drying	Not more than 15 % (105 °C, 4 hours)
Sulphated ash	Not more than 8 % on the anhydrous basis
Sodium hydroxide (1 M solution)	Not more than 2 % on the anhydrous basis insoluble matter
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
Total plate count	Not more than 5 000 colonies per gram
Yeast and moulds	Not more than 500 colonies per gram
E. coli	Negative in 5 g
Salmonella spp.	Negative in 10 g
E 401 SODIUM ALGINATE
Definition
Chemical name	Sodium salt of alginic acid
Chemical formula	(C6H7NaO6)n
Molecular weight	10 000-600 000 (typical average)
Assay	Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222)
Description	Nearly odourless, white to yellowish fibrous or granular powder
Identification
A. Positive test for sodium and alginic acid
Purity
Loss on drying	Not more than 15 % (105 °C, 4 hours)
Water-insoluble matter	Not more than 2 % on the anhydrous basis
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
Total plate count	Not more than 5 000 colonies per gram
Yeast and moulds	Not more than 500 colonies per gram
E. coli	Negative in 5 g
Salmonella spp.	Negative in 10 g
E 402 POTASSIUM ALGINATE
Definition
Chemical name	Potassium salt of alginic acid
Chemical formula	(C6H7KO6)n
Molecular weight	10 000-600 000 (typical average)
Assay	Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)
Description	Nearly odourless, white to yellowish fibrous or granular powder
Identification
A. Positive test for potassium and for alginic acid
Purity
Loss on drying	Not more than 15 % (105 °C, 4 hours)
Water-insoluble matter	Not more than 2 % on the anhydrous basis
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
Total plate count	Not more than 5 000 colonies per gram
Yeast and moulds	Not more than 500 colonies per gram
E. coli	Negative in 5 g
Salmonella spp.	Negative in 10 g
E 403 AMMONIUM ALGINATE
Definition
Chemical name	Ammonium salt of alginic acid
Chemical formula	(C6H11NO6)n
Molecular weight	10 000-600 000 (typical average)
Assay	Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217)
Description	White to yellowish fibrous or granular powder
Identification
A. Positive test for ammonium and alginic acid
Purity
Loss on drying	Not more than 15 % (105 °C, 4 hours)
Sulphated ash	Not more than 7 % on the dried basis
Water-insoluble matter	Not more than 2 % on the anhydrous basis
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals	Not more than 20 mg/kg
Total plate count	Not more than 5 000 colonies per gram
Yeast and moulds	Not more than 500 colonies per gram
E. coli	Negative in 5 g
Salmonella spp.	Negative in 10 g
E 404 CALCIUM ALGINATE
Synonyms	Calcium salt of alginate
Definition
Chemical name	Calcium salt of alginic acid
Chemical formula	(C6H7Ca1/2O6)n
Molecular weight	10 000-600 000 (typical average)
Assay	Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219)
Description	Nearly odourless, white to yellowish fibrous or granular powder
Identification
A. Positive test for calcium and alginic acid
Purity
Loss on drying	Not more than 15,0 % (105 °C, 4 hours)
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
Total plate count	Not more than 5 000 colonies per gram
Yeast and moulds	Not more than 500 colonies per gram
E. coli	Negative in 5 g
Salmonella spp.	Negative in 10 g
E 405 PROPANE-1,2-DIOL ALGINATE
Synonyms	Hydroxypropyl alginate 1,2-propanediol ester of alginic acid Propylene glycol alginate
Definition
Chemical name	Propane-1,2-diol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule
Chemical formula	(C9H14O7)n (esterified)
Molecular weight	10 000—600 000 (typical average)
Assay	Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of CO2 of carbon dioxide
Description	Nearly odourless, white to yellowish brown fibrous or granular powder
Identification
A. Positive test for 1,2-propanediol and alginic acid after hydrolysis
Purity
Loss on drying	Not more than 20 % (105 °C, 4 hours)
Total propane-1,2-diol content	Not less than 15 % and not more than 45 %
Free propane-1,2-diol content	Not more than 15 %
Water-insoluble matter	Not more than 2 % on the anhydrous basis
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
Total plate count	Not more than 5 000 colonies per gram
Yeast and moulds	Not more than 500 colonies per gram
E. coli	Negative in 5 g
Salmonella spp.	Negative in 10 g
E 406 AGAR
Synonyms	Gelose Japan agar Bengal, Ceylon, Chinese or Japanese isinglass Layor Carang
Definition
Chemical name	Agar is a hydrophilic colloidal polysaccharide consisting mainly of D-galactose units. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain natural strains of marine algae of the families Gelidiaceae und Sphaerococcaceae and related red algae of the class Rhodophyceae
Einecs	232-658-1
Assay	The threshold gel concentration should not be higher than 0,25 %
Description	Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, agglutinated strips, or in cut, flaked or granulated forms. It may be light yellowish-orange, yellowish-grey to pale yellow, or colourless. It is tough when damp, brittle when dry. Powdered agar is white to yellowish-white or pale yellow. When examined in water under a microscope, the agar appears granular and somewhat filamentous. A few fragments of the spicules of sponges and a few frustules of diatoms may be present. In chloral hydrate solution, the powdered agar appears more transparent than in water, more or less granular, striated, angular and occasionally contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltodextrines or sucrose
Identification
A. Solubility	Insoluble in cold water; soluble in boiling water
Purity
Loss on drying	Not more than 22 % (105 °C, 5 hours)
Ash	Not more than 6,5 % on the anhydrous basis determined at 550 °C
Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid)	Not more than 0,5 % determined at 550 °C on the anhydrous basis
Insoluble matter (in hot water)	Not more than 1,0 %
Starch	Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced
Gelatin and other proteins	Dissolve about 1 g of agar in 100 ml of boiling water and allow to cool of about 50 °C. To 5 ml of the solution add 5 ml of trinitrophenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes
Water absorption	Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with water, mix and allow to stand at about 25 °C for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100 ml graduated cylinder. Not more than 75 ml of water is obtained
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
▼M6
E 407 CARRAGEENAN
Synonyms	Products of commerce are sold under different names such as: Irish moss gelose Eucheuman (from Eucheuma spp.) Iridophycan (from Iridaea spp.) Hypnean (from Hypnea spp.) Furcellaran or Danish agar (from Furcellaria fastigiata) Carrageenan (from Chondrus and Gigartina spp.)
Definition	Carrageenan is obtained by aqueous extraction of natural strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaeceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded
EINECS	232-524-2
Description	Yellowish to colourless, coarse to fine powder which is practically odourless
Identification
A. Positive tests for galactose, for anhydrogalactose and for sulphate
Purity
Methanol, ethanol, propane-2-ol content	Not more than 0,1 % singly or in combination
Viscosity of a 1,5 % solution at 75 oC	Not less than 5 mPa.s
Loss on drying	Not more than 12 % (105 oC, four hours)
Sulphate	Not less than 15 % and not more than 40 % on the dried basis (as SO4)
Ash	Not less than 15 % and not more than 40 % determined on the dried basis at 550 oC
Acid-insoluble ash	Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)
Acid-insoluble matter	Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid)
Low molecular weight carrageenan (Molecular weight fraction below 50 kDa)	Not more than 5 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Total plate count	Not more than 5 000 colonies per gram
Yeast and moulds	Not more than 300 colonies per gram
E. coli	Negative in 5 g
Salmonella spp.	Negative in 10 g
E 407a PROCESSED EUCHEUMA SEAWEED
Synonyms	PES (acronym for processed eucheuma seaweed)
Definition	Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consist chiefly of the potassium salt of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded
Description	Tan to yellowish, coarse to fine powder which is practically odourless
Identification
A. Positive tests for galactose, for anhydrogalactose and for sulphate
B. Solubility	Forms cloudy viscous suspensions in water. Insoluble in ethanol
Purity
Methanol, ethanol, propane-2-ol content	Not more than 0,1 % singly or in combination
Viscosity of a 1,5 % solution at 75 oC	Not less than 5 mPa.s
Loss on drying	Not more than 12 % (105 oC, four hours)
Sulphate	Not less than 15 % and not more than 40 % on the dried basis (as SO4)
Ash	Not less than 15 % and not more than 40 % determined on the dried basis at 550 oC
Acid-insoluble ash	Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)
Acid-insoluble matter	Not less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid)
Low molecular weight carrageenan (Molecular weight fraction below 50 kDa)	Not more than 5 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Total plate count	Not more than 5 000 colonies per gram
Yeast and moulds	Not more than 300 colonies per gram
E. coli	Negative in 5 g
Salmonella spp.	Negative in 10 g
▼M1
E 410 LOCUST BEAN GUM
Synonyms	Carob bean gum Algaroba gum
Definition	Locust bean gum is the ground endosperm of the seeds of the natural strains of carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
Molecular weight	50 000—3 000 000
Einecs	232-541-5
Assay	Galactomannan content not less than 75 %
Description	White to yellowish-white, nearly odourless powder
Identification
A. Positive tests for galactose mannose
B. Microscopic examination	Place some ground sample in an aqueous solution containing 0,5 % iodine and 1 % potassium iodide on a glass slide and examine under microscope. Locust bean gum contains long stretched tubiform cells, separated or slightly interspaced. Their brown contents are much less regularly formed in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown
C. Solubility	Soluble in hot water, insoluble in ethanol
Purity
Loss on drying	Not more than 15 % (105 °C, 5 hours)
Ash	Not more than 1,2 % determined at 800 °C
Protein (N × 6,25)	Not more than 7 %
Acid-insoluble matter	Not more than 4 %
Starch	Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
Ethanol and propane-2-ol	Not more than 1 %, single or in combination
E 412 GUAR GUM
Synonyms	Gum cyamopsis Guar flour
Definition	Guar gum is the ground endosperm of the seeds of natural strains of the guar plant, Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
Einecs	232-536-0
Molecular weight	50 000—8 000 000
Assay	Galactomannan content not less than 75 %
Description	A white to yellowish-white, nearly odourless powder
Identification
A. Positive tests for galactose and for mannose
B. Solubility	Soluble in cold water
Purity
Loss on drying	Not more than 15 % (105 °C, 5 hours)
Ash	Not more than 1,5 % determined at 800 °C
Acid-insoluble matter	Not more than 7 %
Protein (N × 6,25)	Not more than 10 %
Starch	Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. (No blue colour is produced)
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
E 413 TRAGACANTH
Synonyms	Tragacanth gum Tragant
Definition	Tragacanth is a dried exudation obtained from the stems and branches of natural strains of Astragalus gummifer Labillardiere and other Asiatic species of Astragalus (family Leguminosae). It consists mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose and fucose. Small amounts of rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present
Molecular weight	Approximately 8 000 000
Einecs	232-252-5
Description	Unground Tragacanth gum occurs as flattened, lamellated, straight or curved fragments or as spirally twisted pieces 0,5-2,5 mm thick and up to 3 cm in length. It is white to pale yellow in colour but some pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid mucilaginous taste. Powdered tragacanth is white to pale yellow or pinkish brown (pale tan) in colour
Identification
A. Solubility	1 g of the sample in 50 ml of water swells to form a smooth, stiff, opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol
Purity
Negative test for Karaya gum	Boil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops
Loss on drying	Not more than 16 % (105 °C, 5 hours)
Total ash	Not more than 4 %
Acid insoluble ash	Not more than 0,5 %
Acid insoluble matter	Not more than 2 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
Salmonella spp.	Negative in 10 g
E. coli	Negative in 5 g
E 414 ACACIA GUM
Synonyms	Gum arabic
Definition	Acacia gum is a dried exudation obtained from the stems and branches of natural strains of Acacia senegal (L) Willdenow or closely related species of Acacia (family Leguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid
Molecular weight	Approximately 350 000
Einecs	232-519-5
Description	Unground acacia gum occurs as white or yellowish-white spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spray-dried material.
Identification
A. Solubility	1 g dissolves in 2 ml of cold water forming a solution which flows readily and is acid to litmus, insoluble in ethanol
Purity
Loss on drying	Not more than 17 % (105 °C, 5 hours) for granular and not more than 10 % (105 °C, 4 hours) for spray-dried material
Total ash	Not more than 4 %
Acid insoluble ash	Not more than 0,5 %
Acid insoluble matter	Not more than 1 %
Starch or dextrin	Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced
Tannin	To 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride solution (9 g FeCl3.6H2O made up to 100 ml with water). No blackish colouration or blackish precipitate is formed
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
Hydrolysis products	Mannose, xylose and galacturonic acid are absent (determined by chromatography)
Salmonella spp.	Negative in 10 g
E. coli	Negative in 5 g
▼M7
E 415 XANTHAN GUM
Definition	Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with natural strains of Xanthomonas campestris, purified by recovery with ethanol or propan-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral
Molecular weight	Approximately 1 000 000
Einecs	234-394-2
Assay	Yields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gum
Description	Cream-coloured powder
Identification
A. Solubility	Soluble in water. Insoluble in ethanol
Purity
Loss on drying	Not more than 15 % (105 °C, 21/2hours)
Total ash	Not more than 16 % on the anhydrous basis determined at 650 °C after drying at 105 °C for four hours
Pyruvic acid	Not less than 1,5 %
Nitrogen	Not more than 1,5 %
Ethanol and propan-2-ol	Not more than 500 mg/kg singly or in combination
Lead	Not more than 2 mg/kg
Total plate count	Not more than 5 000 colonies per gram
Yeast and mould	Not more than 300 colonies per gram
E. coli	Absent in 5 g
Salmonella spp.	Absent in 10 g
Xanthomonas campestris	Viable cells absent in 1 g
▼M1
E 416 KARAYA-GUM
Synonyms	Katilo Kadaya Gum sterculia Sterculia Karaya, gum karaya Kullo Kuterra
Definition	Karaya gum is a dried exudation from the stems and branches of natural strains of: Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other species of Cochlospermum (family Bixaceae). It consists mainly of high molecular weight acetylated polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid, together with minor amounts of glucuronic acid
Einecs	232-539-4
Description	Karaya gum occurs in tears of variable size and in broken irregular pieces having a characteristic semi-crystalline appearance. It is pale yellow to pinkish brown in colour, translucent and horny. Powdered karaya gum is a pale grey to pinkish brown. The gum has a distinctive odour of acetic acid
Identification
A. Solubility	Insoluble in ethanol
B. Swelling in ethanol solution	Karaya gum swells in 60 % ethanol distinguishing it from other gums
Purity
Loss on drying	Not more than 20 % (105 °C, 5 hours)
Total ash	Not more than 8 %
Acid insoluble ash	Not more than 1 %
Acid insoluble matter	Not more than 3 %
Volatile acid	Not less than 10 % (as acetic acid)
Starch	Not detectable
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
Salmonella spp.	Negative in 10 g
E. coli	Negative in 5 g
E 417 TARA GUM
Definition	Tara gum is obtained by grinding the endosperm of the seeds of natural strains of Caesalpinia spinosa (family Leguminosae). It consists chiefly of polysaccharides of high molecular weight composed mainly of galactomannans. The principal component consists of a linear chain of (1-4)-β-D-mannopyranose units with α-D-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1)
Einecs	254-409-6
Description	A white to white-yellow odourless powder
Identification
A. Solubility	Soluble in water Insoluble in ethanol
B. Gel formation	To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed
Purity
Loss on drying	Not more than 15 %
Ash	Not more than 1,5 %
Acid insoluble matter	Not more than 2 %
Protein	Not more than 3,5 % (factor N x 5,7)
Starch	Not detectable
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
E 418 GELLAN GUM
Definition	Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by natural strains of Pseudomonas elodea, purified by recovery with isopropyl alcohol, dried, and milled. The high molecular weight polysaccharide is principally composed of a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. The glucuronic acid is neutralised to a mixed potassium, sodium, calcium, and magnesium salt
Einecs	275-117-5
Molecular weight	Approximately 500 000
Assay	Yields, on the dried basis, not less than 3,3 % and not more than 6,8 % of CO2
Description	An off-white powder
Identification
A. Solubility	Soluble in water, forming a viscous solution. Insoluble in ethanol
Purity
Loss on drying	Not more than 15 % after drying (105 °C, 2½ hours)
Nitrogen	Not more than 3 %
Propane-2-ol	Not more than 750 mg/kg
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
Total plate count	Not more than 10 000 colonies per gram
Yeast and mould	Not more than 400 colonies per gram
E. coli	Negative in 5 g
Salmonella spp.	Negative in 10 g
E 422 GLYCEROL
Synonyms	Glycerin Glycerine
Definition
Chemical names	1,2,3-propanetriol Glycerol Trihydroxypropane
Einecs	200-289-5
Chemical formula	C3H8O3
Molecular weight	92,10
Assay	Content not less than 98 % of glycerol on the anhydrous basis
Description	Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable
Identification
A. Acrolein formation on heating	Heat a few drops of the sample in a test tube with about 0,5 g of potassium bisulphate. The characteristic pungent vapours of acrolein are evolved
B. Specific gravity (25/25 °C)	Not less than 1,257
C. Refractive index [n]D20	Between 1,471 and 1,474
Purity
Water	Not more than 5 % (Karl Fischer method)
Sulphated ash	Not more than 0,01 % determined at 800 ± 25 °C
Butanetriols	Not more than 0,2 %
Acrolein, glucose and ammonium compounds	Heat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide solution (1 in 10) at 60 °C for five minutes. It neither becomes yellow nor emits an odour of ammonia
Fatty acids and esters	Not more than 0,1 % calculated as butyric acid
Chlorinated compounds	Not more than 30 mg/kg (as chlorine)
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
Heavy metals (as Pb)	Not more than 5 mg/kg
▼M5
E 431 POLYOXYETHYLENE (40) STEARATE
Synonyms	Polyoxyl (40) stearate
	polyoxyethylene (40) monostearate
Definition	A mixture of the mono- and diesters of edible commercial stearic acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol
Assay	Content not less than 97,5 % on the anhydrous basis
Description	Cream-coloured flakes or waxy solid at 25 °C with a faint odour
Identification
A. Solubility	Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil
B. Congealing range	39 °C — 44 °C
C. Infrared absorption spectrum	Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water	Not more than 3 % (Karl Fischer method)
Acid value	Not more than 1
Saponification value	Not less than 25 and not more than 35
Hydroxyl value	Not less than 27 and not more than 40
1,4-dioxane	Not more than 5 mg/kg
Ethylene oxide	Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-)	Not more than 0,25 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)
Synonyms	Polysorbate 20 Polyoxyethylene (20) sorbitan monolaurate
Definition	A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial lauric acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay	Content not less than 70 % of oxyethylene groups, equivalent to not less than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on the anhydrous basis
Description	A lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour
Identification
A. Solubility	Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether
B. Infrared absorption spectrum	Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water	Not more than 3 % (Karl Fischer method)
Acid value	Not more than 2
Saponification value	Not less than 40 and not more than 50
Hydroxyl value	Not less than 96 and not more than 108
1,4-Dioxane	Not more than 5 mg/kg
Free ethylene oxide	Not more than 1 mg/kg
Ethylene glycols (mono- and di-)	Not more than 0,25 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)
Synonyms	Polysorbate 80
	Polyoxyethylene (20) sorbitan monooleate
Definition	A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay	Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis
Description	A lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour
Identification
A. Solubility	Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether
B. Infrared absorption spectrum	Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water	Not more than 3 % (Karl Fischer method)
Acid value	Not more than 2
Saponification value	Not less than 45 and not more than 55
Hydroxyl value	Not less than 65 and not more than 80
1,4-dioxane	Not more than 5 mg/kg
Ethylene oxide	Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-)	Not more than 0,25 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)
Synonyms	Polysorbate 40
	Polyoxyethylene (20) sorbitan monopalmitate
Definition	A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial palmitic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay	Content not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basis
Description	A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic odour
Identification
A. Solubility	Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil
B. Infrared absorption spectrum	Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water	Not more than 3 % (Karl Fischer method)
Acid value	Not more than 2
Saponification value	Not less than 41 and not more than 52
Hydroxyl value	Not less than 90 and not more than 107
1,4-dioxane	Not more than 5 mg/kg
Ethylene oxide	Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-)	Not more than 0,25 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)
Synonyms	Polysorbate 60 Polyoxyethylene (20) sorbitan monostearate
Definition	A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay	Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis
Description	A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic odour
Identification
A. Solubility	Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils
B. Infrared absorption spectrum	Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water	Not more than 3 % (Karl Fischer method)
Acid value	Not more than 2
Saponification value	Not less than 45 and not more than 55
Hydroxyl value	Not less than 81 and not more than 96
1,4-Dioxane	Not more than 5 mg/kg
Free ethylene oxide	Not more than 1 mg/kg
Ethylene glycols (mono- and di-)	Not more than 0,25 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)
Synonyms	Polysorbate 65
	Polyoxyethylene (20) sorbitan tristearate
Definition	A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay	Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis
Description	A tan-coloured, waxy solid at 25 °C with a faint characteristic odour
Identification
A. Solubility	Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol
B. Congealing range	29 — 33 °C
C. Infrared absorption spectrum	Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water	Not more than 3 % (Karl Fischer method)
Acid value	Not more than 2
Saponification value	Not less than 88 and not more than 98
Hydroxyl value	Not less than 40 and not more than 60
1,4-dioxane	Not more than 5 mg/kg
Ethylene oxide	Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-)	Not more than 0,25 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
▼M1
E 440 (i) PECTIN
Definition	Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of natural strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol
Einecs	232-553-0
Assay	Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
Description	White, light yellow, light grey or light brown powder
Identification
A. Solubility	Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
Purity
Loss on drying	Not more than 12 % (105 °C, 2 hours)
Acid insoluble ash	Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Sulphur dioxide	Not more than 50 mg/kg on the anhydrous basis
Nitrogen content	Not more than 1,0 % after washing with acid and ethanol
Free methanol, ethanol and propane-2-ol	Not more than 1 %, singly or in combination, on the anhydrous basis
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
E 440 (ii) AMIDATED PECTIN
Definition	Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate natural strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol
Assay	Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
Description	White, light yellow, light greyish or light brownish powder
Identification
A. Solubility	Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
Purity
Loss on drying	Not more than 12 % (105 °C, 2 hours)
Acid-insoluble ash	Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Degree of amidation	Not more than 25 % of total carboxyl groups
Sulphur dioxide residue	Not more than 50 mg/kg on the anhydrous basis
Nitrogen content	Not more than 2,5 % after washing with acid and ethanol
Free methanol, ethanol and propane-2-ol	Not more than 1 % single or in combination, on a volatile matter-free basis
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
E 442 AMMONIUM PHOSPHATIDES
Synonyms	Ammonium salts of phosphatidic acid, mixed ammonium salts of phoshorylated glycerides
Definition	A mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil (usually partially hardened rapeseed oil). One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides
Assay	The phosphorus content is not less than 3 % and not more than 3,4 % by weight; the ammonium content is not less than 1,2 % and not more than 1,5 % (calculated as N)
Description	Unctuous semi-solid
Identification
A. Solubility	Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone
B. Positive tests for glycerol, for fatty acid and for phosphate
Purity
Petroleum ether insoluble matter	Not more than 2,5 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 444 SUCROSE ACETATE ISOBUTYRATE
Synonyms	SAIB
Definition	Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6
Einecs	204-771-6
Chemical name	Sucrose diacetate hexaisobutyrate
Chemical formulae	C40H62O19
Molecular weight	832-856 (approximate), C40H62O19: 846,9
Assay	Content not less than 98,8 % and not more than 101,9 % of C40H62O19
Description	A pale straw-coloured liquid, clear and free of sediment and having a bland odour
Identification
A. Solubility	Insoluble in water. Soluble in most organic solvents
B. Refractive index	D: 1,4492 - 1,4504
C. Specific gravity	D: 1,141 - 1,151
Purity
Triacetin	Not more than 0,1 %
Acid value	Not more than 0,2
Saponification value	Not less than 524 and not more than 540
Arsenic	Not more than 3 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 3 mg/kg
Heavy metals (as Pb)	Not more than 5 mg/kg
E 445 GLYCEROL ESTERS OF WOOD ROSIN
Synonyms	Ester gum
Definition	A complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C20H30O2, chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation
Description	Hard, yellow to pale amber-coloured solid
Identification
A. Solubility	Insoluble in water, soluble in acetone
B. Infrared absorption spectrum	Characteristic of the compound
Purity
Specific gravity of solution	25 not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, boilding point 175,5-176 °C, 4: 0,84)
Ring and ball softening range	Between 82 °C and 90 °C
Acid value	Not less than 3 and not more than 9
Hydroxyl value	Not less than 15 and not more than 45
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
Test for absence of tall oil rosin (sulphur test)	When sulphur-containing organic compounds are heated in the presence of sodium formate, the sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of wood rosin
▼M4
E 450 (i) DISODIUM DIPHOSPHATE
Synonyms	Disodium dihydrogen diphosphate Disodium dihydrogen pyrophosphate Sodium acid pyrophosphate Disodium pyrophosphate
Definition
Chemical name	Disodium dihydrogen diphosphate
Einecs	231-835-0
Chemical formula	Na2H2P2O7
Molecular weight	221,94
Assay	Content not less than 95 % of disodium diphosphate.
P2O5 Content	Not less than 63,0 % and not more than 64,5 %
Description	White powder or grains
Identification
A. Positive tests for sodium and for phosphate
B. Solubility	Soluble in water
C. pH of a 1 % solution	Between 3,7 and 5,0
Purity
Loss on drying	Not more than 0,5 % (105 °C, four hours)
Water-insoluble matter	Not more than 1 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 450 (ii) TRISODIUM DIPHOSPHATE
Synonyms	Acid trisodium pyrophosphate Trisodium monohydrogen diphosphate
Definition
Einecs	238-735-6
Chemical formula	Monohydrate: Na3HP2O7 · H2O Anhydrous: Na3HP2O7
Molecular weight	Monohydrate: 261,95 Anhydrous: 243,93
Assay	Content not less than 95 % on the anhydrous basis
P2O5 content	Not less than 57 % and not more than 59 %
Description	White powder or grains, occurs anhydrous or as a monohydrate
Identification
A. Positive tests for sodium and for phosphate
B. Soluble in water
C. pH of a 1 % solution	Between 6,7 and 7,5
Purity
Loss on ignition	Not more than 4,5 % on the anhydrous compound Not more than 11,5 % on the monohydrous basis
Loss on drying	Not more than 0,5 % (105 °C, four hours)
Water-insoluble matter	Not more than 0,2 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 450 (iii) TETRASODIUM DIPHOSPHATE
Synonyms	Tetrasodium pyrophosphate Sodium pyrophosphate
Definition
Chemical name	Tetrasodium diphosphate
Einecs	231-767-1
Chemical formula	Anhydrous: Na4P2O7 Decahydrate: Na4P2O7 · 10H2O
Molecular weight	Anhydrous: 265,94 Decahydrate: 446,09
Assay	Content not less than 95 % of Na4P2O7 on the ignited basis
P2O5 content	Not less than 52,5 % and not more than 54,0 %
Description	Colourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces slightly in dry air
Identification
A. Positive tests for sodium and for phosphate
B. Solubility	Soluble in water. Insoluble in ethanol
C. pH of a 1 % solution	Between 9,8 and 10,8
Purity
Loss on ignition	Not more than 0,5 % for the anhydrous salt, not less than 38 % and not more than 42 % for the decahydrate, in both cases determined after drying at 105 °C for four hours, followed by ignition at 550 °C for 30 minutes
Water-insoluble matter	Not more than 0,2 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 450 (v) TETRAPOTASSIUM DIPHOSPHATE
Synonyms	Potassium pyrophosphate Tetrapotassium pyrophosphate
Definition
Chemical name	Tetrapotassium diphosphate
Einecs	230-785-7
Chemical formula	K4P2O7
Molecular weight	330,34 (anhydrous)
Assay	Content not less than 95 % on the ignited basis
P2O5 content	Not less than 42,0 % and not more than 43,7 % on the anhydrous basis
Description	Colourless crystals or white, very hygroscopic powder
Identification
A. Positive tests for potassium and for phosphate
B. Solubility	Soluble in water, insoluble in ethanol
C. pH of a 1 % solution	Between 10,0 and 10,8
Purity
Loss on ignition	Not more than 2 % after drying at 105 °C for four hours and then ignition at 550 °C for 30 minutes
Water-insoluble substances	Not more than 0,2 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 450 (vi) DICALCIUM DIPHOSPHATE
Synonyms	Calcium pyrophosphate
Definition
Chemical name	Dicalcium diphosphate Dicalcium pyrophosphate
Einecs	232-221-5
Chemical formula	Ca2P2O7
Molecular weight	254,12
Assay	Content not less than 96 %
P2O5 content	Not less than 55 % and not more than 56 %
Description	A fine, white, odourless powder
Identification
A. Positive tests for calcium and for phosphate
B. Solubility	Insoluble in water. Soluble in dilute hydrochloric and nitric acids
C. pH of a 10 % suspension in water	Between 5,5 and 7,0
Purity
Loss on ignition	Not more than 1,5 % at 800 °C ± 25 °C for 30 minutes
Fluoride	Not more than 50 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE
Synonyms	Acid calcium pyrophosphate Monocalcium dihydrogen pyrophosphate
Definition
Chemical name	Calcium dihydrogen diphosphate
Einecs	238-933-2
Chemical formula	CaH2P2O7
Molecular weight	215,97
Assay	Content not less than 90 % on the anhydrous basis
P2O5 content	Not less than 61 % and not more than 64 %
Description	White crystals or powder
Identification
A. Positive tests for calcium and for phosphate
Purity
Acid-insoluble matter	Not more than 0,4 %
Fluoride	Not more than 30 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 451 (i) PENTASODIUM TRIPHOSPHATE
Synonyms	Pentasodium tripolyphosphate Sodium tripolyphosphate
Definition
Chemical name	Pentasodium triphosphate
Einecs	231-838-7
Chemical formula	Na5O10P3 · nH2O (n = 0 or 6)
Molecular weight	367,86
Assay	Content not less than 85,0 % (anhydrous) or 65,0 % (hexahydrate)
P2O5 content	Not less than 56 % and not more than 59 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate)
Description	White, slightly hygroscopic granules or powder
Identification
A. Solubility	Freely soluble in water. Insoluble in ethanol
B. Positive tests for sodium and for phosphate
C. pH of a 1 % solution	Between 9,1 and 10,2
Purity
Loss on drying	Anhydrous: Not more than 0,7 % (105 °C, one hour) Hexahydrate: Not more than 23,5 % (60 °C, one hour, followed by drying at 105 °C, four hours)
Water-insoluble substances	Not more than 0,1 %
Higher polyphosphates	Not more than 1 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE
Synonyms	Pentapotassium tripolyphosphate Potassium triphosphate Potassium tripolyphosphate
Definition
Chemical name	Pentapotassium triphosphate Pentapotassium tripolyphosphate
Einecs	237-574-9
Chemical formula	K5O10P3
Molecular weight	448,42
Assay	Content not less than 85 % on the anhydrous basis
P2O5 content	Not less than 46,5 % and not more than 48 %
Description	White, very hygroscopic powder or granules
Identification
A. Solubility	Very soluble in water
B. Positive tests for potassium and for phosphate
C. pH of a 1 % solution	Between 9,2 and 10,5
Purity
Loss on ignition	Not more than 0,4 % (after drying at 105 °C, four hours, followed by ignition at 550 °C, 30 minutes)
Water-insoluble matter	Not more than 2 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 452 (i) SODIUM POLYPHOSPHATE
1. SOLUBLE POLYPHOSPHATE
Synonyms	Sodium hexametaphosphate Sodium tetrapolyphosphate Graham's salt Sodium polyphosphates, glassy Sodium polymetaphosphate Sodium metaphosphate
Definition	Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (NaPO3)x where x ≥ 2, terminated by Na2PO4 groups. These substances are usually identified by their Na2O/P2O5 ratio or their P2O5 content. The Na2O/P2O5 ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham's salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0
Chemical name	Sodium polyphosphate
Einecs	272-808-3
Chemical formula	Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2
Molecular weight	(102)n
Assay P2O5 content	Not less than 60 % and not more than 71 % on the ignited basis
Description	Colourless or white, transparent platelets, granules, or powders
Identification
A. Solubility	Very soluble in water
B. Positive tests for sodium and for phosphate
C. pH of a 1 % solution	Between 3,0 and 9,0
Purity
Loss on ignition	Not more than 1 %
Water-insoluble matter	Not more than 0,1 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
2. INSOLUBLE POLYPHOSPHATE I
Synonyms	Insoluble sodium metaphosphate Maddrell's salt Insoluble sodium polyphosphate, IMP
Definition	Insoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two long metaphosphate chains (NaPO3)x that spiral in opposite directions about a common axis. The Na2O/P2O5 ratio is about 1,0. The pH of 1 in 3 suspension in water is about 6,5
Chemical name	Sodium polyphosphate
Einecs	272-808-3
Chemical formula	Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2
Molecular weight	(102)n
P2O5 content	Not less than 68,7 % and not more than 70,0 %
Description	White crystalline powder
Identification
A. Solubility	Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides
B. Positive tests for sodium and for phosphate
C. pH of 1 in 3 suspension in water	About 6,5
Purity
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 452 (ii) POTASSIUM POLYPHOSPHATE
Synonyms	Potassium metaphosphate Potassium polymetaphosphate Kurrol salt
Definition
Chemical name	Potassium polyphosphate
Einecs	232-212-6
Chemical formula	(KPO3)n Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1)where ‘n’ is not less than 2
Molecular weight	(118)n
P2O5 content	Not less than 53,5 % and not more than 61,5 % on the ignited basis
Description	Fine white powder or crystals or colourless glassy platelets
Identification
A. Solubility	1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate
B. Positive tests for potassium and for phosphate
C. pH of a 1 % suspension	Not more than 7,8
Purity
Loss on ignition	Not more than 2 % (105 °C, four hours followed by ignition at 550 °C, 30 minutes)
Cyclic phosphate	Not more than 8 % on P2O5 content
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
E 452 (iv) CALCIUM POLYPHOSPHATE
Synonyms	Calcium metaphosphate Calcium polymetaphosphate
Definition
Chemical name	Calcium polyphosphate
Einecs	236-769-6
Chemical formula	(CaP2O6)n Heterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1) where ‘n’ is not less than 2
Molecular weight	(198)n
P2O5 content	Not less than 71 % and not more than 73 % on the ignited basis
Description	Odourless, colourless crystals or white powder
Identification
A. Solubility	Usually sparingly soluble in water. Soluble in acid medium
B. Positive tests for calcium and for phosphate
C. CaO content	27 to 29,5 %
Purity
Loss on ignition	Not more than 2 % (105 °C, four hours followed by ignition at 550 °C, 30 minutes)
Cyclic phosphate	Not more than 8 % on P2O5 content
Fluoride	Not more than 30 mg/kg (expressed as fluorine)
Arsenic	Not more than 3 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 4 mg/kg
Mercury	Not more than 1 mg/kg
▼M1
E 460 (i) MICROCRISTALLINE CELLULOSE
Synonyms	Cellulose gel
Definition	Microcrystalline cellulose is purified, partally depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from natural strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400
Chemical name	Cellulose
Einecs	232-674-9
Chemical formula	(C6H10O5)n
Molecular weight	About 36 000
Assay	Not less than 97 % calculated as cellulose on the anhydrous basis
Description	A fine white or almost white odourless powder
Identification
A. Solubility	Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
B. Colour reaction	To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyrocatechol in phosphoric acid and heat for 30 minutes, A red colour is produced
C. To be identified by IR spectroscopy
D. Suspension test	Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-following suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears
Purity
Loss on drying	Not more than 7 % (105 °C, 3 hours)
Water-soluble matter	Not more than 0,24%
Sulphated ash	Not more than 0,5 % determined at 800 ± 25 °C
pH of a 10 % suspension in water	The pH of the supernatant liquid is between 5,0 and 7,5
Starch	Not detectable To 20 ml of the dispersion obtained in identification, test D, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
Particle size	Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
Carboxyl groups	Not more than 1 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
E 460 (ii) POWDERED CELLULOSE
Definition	Purified, mechanically disintegrated celluslose prepared by processing alpha-cellulose obtained as a pulp from natural strains of fibrous plant materials
Chemical name	Cellulose Linear polymer of 1:4 linked glucose residues
Einecs	232-674-9
Chemical formula	(C6H10O5)n
Molecular weight	(162)n (n is predominantly 1 000 and greater)
Assay	Content not less than 92 %
Description	A white, odourless powder
Identification
A. Solubility	Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
B. Suspension test	Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-flowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears
Purity
Loss on drying	Not more than 7 % (105 °C, 3 hours)
Water-soluble matter	Not more than 1,0 %
Sulphated ash	Not more than 0,3 % determined at 800 ± 25 °C
pH of a 10 % suspension in water	The pH of the supernatant liquid is between 5,0 and 7,5
Starch	Not detectable To 20 ml of the dispersion obtained in identification, test B, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
Particle size	Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
E 461 METHYL CELLULOSE
Synonyms	Cellulose methyl ether
Definition	Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups
Chemical name	Methyl ether of cellulose
Chemical formula	The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following: — H — CH3 or — CH2CH3
Molecular weight	From about 20 000 to 380 000
Assay	Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)
Description	Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification
A. Solubility	Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ehtanol, ether and chloroform. Soluble in glacial acetic acid
Purity
Loss on drying	Not more than 10 % (105 °C, 3 hours)
Sulphated ash	Not more than 1,5 % determined at 800 ± 25 °C
pH of a 1 % colloidal solution	Not less than 5,0 and not more than 8,0
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 20 mg/kg
▼M7
E 462 ETHYL CELLULOSE
Synonyms	Cellulose ethyl ether
Definition	Ethyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groups
Chemical names	Ethyl ether of cellulose
Chemical formula	The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2) where R1 and R2 may be any of the following: — H — CH2CH3
Assay	Content not less than 44 % and not more than 50 % of ethoxyl groups (-OC2H5) on the dried basis (equivalent to not more than 2,6 ethoxyl groups per anhydroglucose unit)
Description	Slightly hygroscopic, white to off white, odourless and tasteless powder
Identification
A. Solubility	Practically insoluble in water, in glycerol and in propane-1,2-diol but soluble in varying proportions in certain organic solvents depending upon the ethoxyl content. Ethyl cellulose containing less than 46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydrocarbon ethanol mixtures. Ethyl cellulose containing 46 to 48 % or more of ethoxyl groups is freely soluble in ethanol, in methanol, in toluene, in chloroform and in ethyl acetate
B. Film forming test	Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of toluene ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml of the solution onto a glass plate and allow the solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable
Purity
Loss on drying

		Official Journal
		No	page	date
►M1	COMMISSION DIRECTIVE 98/86/EC Text with EEA relevance of 11 November 1998	L 334	1	9.12.1998
►M2	COMMISSION DIRECTIVE 2000/63/EC Text with EEA relevance of 5 October 2000	L 277	1	30.10.2000
►M3	COMMISSION DIRECTIVE 2001/30/EC Text with EEA relevance of 2 May 2001	L 146	1	31.5.2001
►M4	COMMISSION DIRECTIVE 2002/82/EC Text with EEA relevance of 15 October 2002	L 292	1	28.10.2002
►M5	COMMISSION DIRECTIVE 2003/95/EC Text with EEA relevance of 27 October 2003	L 283	71	31.10.2003
►M6	COMMISSION DIRECTIVE 2004/45/EC Text with EEA relevance of 16 April 2004	L 113	19	20.4.2004
►M7	COMMISSION DIRECTIVE 2006/129/EC Text with EEA relevance of 8 December 2006	L 346	15	9.12.2006