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

Type Regulation

Publication 2012-03-22

Last updated 2026-08-18

State In force

Department European Commission

Source EUR-Lex

articles 4

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Synonyms	Polysorbate 80; Polyoxyethylene (20) sorbitan monooleate
Definition	A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Einecs
Chemical name
Chemical formula
Molecular weight
Assay	Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis
Description	A lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour
Identification	Identification
Solubility	Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether
Infrared absorption spectrum	Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity	Purity
Water content	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 glycols (mono- and di-)	Not more than 0,25 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg

E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)


Synonyms	Polysorbate 40; Polyoxyethylene (20) sorbitan monopalmitate
Definition	A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial palmitic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Einecs
Chemical name
Chemical formula
Molecular weight
Assay	Content not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan 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	Identification
Solubility	Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil
Infrared absorption spectrum	Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity	Purity
Water content	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 glycols (mono- and di-)	Not more than 0,25 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg

E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)


Synonyms	Polysorbate 60; Polyoxyethylene (20) sorbitan monostearate
Definition	A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Einecs
Chemical name
Chemical formula
Molecular weight
Assay	Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis
Description	A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic odour
Identification	Identification
Solubility	Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils
Infrared absorption spectrum	Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity	Purity
Water content	Not more than 3 % (Karl Fischer method)
Acid value	Not more than 2
Saponification value	Not less than 45 and not more than 55
Hydroxyl value	Not less than 81 and not more than 96
1,4-dioxane	Not more than 5 mg/kg
—————	—————

Ethylene glycols (mono- and di-)	Not more than 0,25 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg

E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)


Synonyms	Polysorbate 65; Polyoxyethylene (20) sorbitan tristearate
Definition	A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Einecs
Chemical name
Chemical formula
Molecular weight
Assay	Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis
Description	A tan-coloured, waxy solid at 25 °C with a faint characteristic odour
Identification	Identification
Solubility	Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol
Congealing range	29-33 °C
Infrared absorption spectrum	Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity	Purity
Water content	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 glycols (mono- and di-)	Not more than 0,25 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg

E 440 (I) PECTIN


Synonyms
Definition	Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of strains of appropriate edible plant material, usually citrus fruits or apples. The final product must not show any residual enzyme activity. No organic precipitant shall be used other than methanol, ethanol and propan-2-ol.
Einecs	232-553-0
Chemical name
Chemical formula
Molecular weight
Assay	Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
Description	White, light yellow, light grey or light brown powder
Identification
Solubility	Dispersible in water forming a colloidal, opalescent dispersion. Insoluble in ethanol.
Purity
Loss on drying	Not more than 12 % (105 °C, 2 hours)
Acid insoluble ash	Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Sulphur dioxide	Not more than 50 mg/kg on the anhydrous basis
Nitrogen content	Not more than 1,0 % after washing with acid and ethanol
Total insolubles	Not more than 3 %
Solvent residues	Not more than 1 % of free methanol, ethanol and propan-2-ol, singly or in combination, on the volatile matter-free basis
Arsenic	Not more than 0,1 mg/kg
Lead	Not more than 0,3 mg/kg (only if added to foods for infants and young children) Not more than 1 mg/kg (for all uses except for foods intended for infants and young children)
Mercury	Not more than 0,1 mg/kg
Cadmium	Not more than 0,1 mg/kg (only if added to foods for infants and young children) Not more than 0,5 mg/kg (for all uses except for foods intended for infants and young children)
Aluminium	Not more than 120 mg/kg (only if added to foods for infants and young children) Not more than 200 mg/kg (for all uses except for foods intended for infants and young children)
Microbiological criteria
Enterobacteriaceae	Absent in 10 g (only if added to dried infant formulae, dried foods for special medical purposes intended for infants below 6 months of age and dried follow-on formulae)
Escherichia coli	Absent in 10 g
Salmonella spp.	Absent in 25 g (only if added to dried infant formulae, dried foods for special medical purposes intended for infants below 6 months of age and dried follow-on formulae)
Cronobacter spp. (Enterobacter sakazakii)	Absent in 10 g (only if added to dried infant formulae and dried foods for special medical purposes intended for infants below 6 months of age)

E 440 (II) AMIDATED PECTIN


Synonyms
Definition	Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. The final product must not show any residual enzyme activity. No organic precipitant shall be used other than methanol, ethanol and propan-2-ol.
Einecs
Chemical name
Chemical formula
Molecular weight
Assay	Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
Description	White, light yellow, light greyish or light brownish powder
Identification
Solubility	Dispersible in water forming a colloidal, opalescent dispersion. 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	Not more than 50 mg/kg on the anhydrous basis
Nitrogen content	Not more than 2,5 % after washing with acid and ethanol
Total insolubles:	Not more than 3 %
Solvent residues	Not more than 1 % of methanol, ethanol and propan-2-ol, singly or in combination, on a volatile matter-free basis
Arsenic	Not more than 0,1 mg/kg
Lead	Not more than 0,3 mg/kg (only if added to foods for infants and young children) Not more than 1 mg/kg (for all uses except for foods intended for infants and young children)
Mercury	Not more than 0,1 mg/kg
Cadmium	Not more than 0,1 mg/kg (only if added to foods for infants and young children) Not more than 0,5 mg/kg (for all uses except for foods intended for infants and young children)
Aluminium	Not more than 120 mg/kg (only if added to foods for infants and young children) Not more than 200 mg/kg (for all uses except for foods intended for infants and young children)
Microbiological criteria
Enterobacteriaceae	Absent in 10 g (only if added to dried infant formulae, dried foods for special medical purposes intended for infants below 6 months of age and dried follow-on formulae)
Escherichia coli	Absent in 10 g
Salmonella spp.	Absent in 25 g (only if added to dried infant formulae, dried foods for special medical purposes intended for infants below 6 months of age and dried follow-on formulae)
Cronobacter spp. (Enterobacter sakazakii)	Absent in 10 g (only if added to dried infant formulae and dried foods for special medical purposes intended for infants below 6 months of age)

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. One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides
Einecs
Chemical name
Chemical formula
Molecular weight
Assay	The phosphorus content is not less than 3 % and not more than 3,4 % by weight; the ammonium content is not less than 1,2 % and not more than 1,5 % (calculated as N)

Description	Unctuous semi-solid to oily liquid

Identification	Identification
Solubility	Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone
Test for glycerol	Passes test
Test fatty acids	Passes test
Test for phosphate	Passes test
Purity	Purity
Petroleum ether insoluble matter	Not more than 2,5 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg

E 444 SUCROSE ACETATE ISOBUTYRATE


Synonyms	SAIB
Definition	Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6
Einecs	204-771-6
Chemical name	Sucrose diacetate hexaisobutyrate
Chemical formula	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	Identification
Solubility	Insoluble in water. Soluble in most organic solvents
Refractive index	[n]D ⁴⁰: 1,4492-1,4504
Specific gravity	[d]²⁵ D: 1,141-1,151
Purity	Purity
Triacetin	Not more than 0,1 %
Acid value	Not more than 0,2
Saponification value	Not less than 524 and not more than 540
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg

E 445 GLYCEROL ESTERS OF WOOD ROSIN


Synonyms	Ester gum
Definition	A complex mixture of tri- and diglycerol esters of resin acids from wood 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
Einecs
Chemical name
Chemical formula
Molecular weight
Assay
Description	Hard, yellow to pale amber-coloured solid
Identification	Identification
Solubility	Insoluble in water, soluble in acetone
Infrared absorption spectrum	Characteristic of the compound
Purity	Purity
Specific gravity of solution	[d]²⁰ 25 not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, boiling point 175,5-176 °C, d²⁰ 4: 0,84)
Ring and ball softening range	Between 82 °C and 90 °C
Acid value	Not less than 3 and not more than 9
Hydroxyl value	Not less than 15 and not more than 45
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Test for absence of tall oil rosin (sulphur test)	When sulphur-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

E 450 (i) DISODIUM DIPHOSPHATE


Synonyms	Disodium dihydrogen diphosphate; Disodium dihydrogen pyrophosphate; Sodium acid pyrophosphate; Disodium pyrophosphate
Definition	Definition
Einecs	231-835-0
Chemical name	Disodium dihydrogen diphosphate
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	Identification
Test for sodium	Passes test
Test for phosphate	Passes test
Solubility	Soluble in water
pH	Between 3,7 and 5,0 (1 % solution)
Purity	Purity
Loss on drying	Not more than 0,5 % (105 °C, 4 hours)
Water insoluble matter	Not more than 1 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg
Aluminium	Not more than 200 mg/kg

E 450 (ii) TRISODIUM DIPHOSPHATE


Synonyms	Trisodium pyrophosphate; Trisodium monohydrogen diphosphate; Trisodium monohydrogen pyrophosphate; Trisodium diphosphate
Definition	Definition
Einecs	238-735-6
Chemical name
Chemical formula	Monohydrate: Na3HP2O7 · H2O Anhydrous: Na3HP2O7
Molecular weight	Monohydrate: 261,95 Anhydrous: 243,93
Assay	Content not less than 95 % on the dried basis P2O5 content not less than 57 % and not more than 59 %
Description	White powder or grains, occurs anhydrous or as a monohydrate
Identification	Identification
Test for sodium	Passes test
Test for phosphate	Passes test
Solubility	Soluble in water
pH	Between 6,7 and 7,5 (1 % solution)
Purity	Purity
Loss on ignition	Not more than 4,5 % on the anhydrous compound (450-550 °C). Not more than 11,5 % on the monohydrate basis
Loss on drying	Not more than 0,5 % (105 °C, 4 hours) for anhydrous Not more than 1,0 % (105 °C, 4 hours) for monohdyrate
Water insoluble matter	Not more than 0,2 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg

E 450 (iii) TETRASODIUM DIPHOSPHATE


Synonyms	Tetrasodium pyrophosphate; Tetrasodium disphosphate; Tetrasodium phosphate
Definition	Definition
Einecs	231-767-1
Chemical name	Tetrasodium diphosphate
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	Identification
Test for sodium	Passes test
Test for phosphate	Passes test
Solubility	Soluble in water. Insoluble in ethanol
pH	Between 9,8 and 10,8 (1 % solution)
Purity	Purity
Loss on ignition	Not more than 0,5 % for the anhydrous salt, not less than 38 % and not more than 42 % for the decahydrate (105 °C, 4 hours then 550 °C, 30 minutes)
Water insoluble matter	Not more than 0,2 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1mg/kg
Mercury	Not more than 1 mg/kg

E 450 (v) TETRAPOTASSIUM DIPHOSPHATE


Synonyms	Tetrapotassium pyrophosphate
Definition	Definition
Einecs	230-785-7
Chemical name	Tetrapotassium diphosphate
Chemical formula	K4P2O7
Molecular weight	330,34 (anhydrous)
Assay	Content not less than 95 % (800 °C for 0,5 hours) P2O5 content not less than 42,0 % and not more than 43,7 % on the anhydrous basis
Description	Colourless crystals or white, very hygroscopic powder
Identification	Identification
Test for potassium	Passes test
Test for phosphate	Passes test
Solubility	Soluble in water, insoluble in ethanol
pH	Between 10,0 and 10,8 (1 % solution)
Purity	Purity
Loss on ignition	Not more than 2 % (105 °C, 4 hours then 550 °C, 30 minutes)
Water insoluble matter	Not more than 0,2 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg

E 450 (vi) DICALCIUM DIPHOSPHATE


Synonyms	Calcium pyrophosphate
Definition	Definition
Einecs	232-221-5
Chemical name	Dicalcium diphosphate Dicalcium pyrophosphate
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	Identification
Test for calcium	Passes test
Test for phosphate	Passes test
Solubility	Insoluble in water. Soluble in dilute hydrochloric and nitric acids
pH	Between 5,5 and 7,0 (10 % suspension in water)
Purity	Purity
Loss on ignition	Not more than 1,5 % (800 °C ± 25 °C, 30 minutes
Fluoride	Not more than 50 mg/kg (expressed as fluorine)
Arsenic	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg

E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE


Synonyms	Acid calcium pyrophosphate; Monocalcium dihydrogen pyrophosphate
Definition	Definition
Einecs	238-933-2
Chemical name	Calcium dihydrogen diphosphate
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 66 %
Description	White crystals or powder
Identification	Identification
Test for calcium	Passes test
Test for phosphate	Passes test
Purity	Purity
Acid-insoluble matter	Not more than 0,4 %
Fluoride	Not more than 30 mg/kg (expressed as fluorine)
Arsenic	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg
Aluminium	Not more than 800 mg/kg. This applies until 31 March 2015. Not more than 200 mg/kg. This applies from 1 April 2015.

E 450 (ix) MAGNESIUM DIHYDROGEN DIPHOSPHATE


Synonyms	Acid magnesium pyrophosphate, monomagnesium dihydrogen pyrophosphate; magnesium diphosphate, magnesium pyrophosphate
Definition	Magnesium dihydrogen diphosphate is the acidic magnesium salt of diphosphoric acid. It is manufactured by adding an aqueous dispersion of magnesium hydroxide slowly to phosphoric acid, until a molar ratio about 1:2 between Mg and P is reached. The temperature is held under 60 °C during the reaction. About 0,1 % hydrogen peroxide is added to the reaction mixture and the slurry is then heated and milled.
EINECS	244-016-8
Chemical name	Mono magnesium dihydrogen diphosphate
Chemical formula	MgH2P2O7
Molecular Weight	200,25
Assay	P2O5 content not less than 68,0 % and not more than 70,5 % expressed as P2O5 MgO content not less than 18,0 % and not more than 20,5 % expressed as MgO
Description	White crystals or powder
Identification	Identification
Solubility	Slightly soluble in water, practically insoluble in ethanol
Particle size:	The average particle size will deviate between 10 and 50 μm
Purity	Purity
Loss on ignition	Not more than 12 % (800 °C, 0,5 hours)
Fluoride	Not more than 20 mg/kg (expressed as fluorine)
Aluminium	Not more than 50 mg/kg
Arsenic	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg.
Lead	Not more than 1 mg/kg

E 451 (i) PENTASODIUM TRIPHOSPHATE


Synonyms	Pentasodium tripolyphosphate; Sodium tripolyphosphate
Definition	Definition
Einecs	231-838-7
Chemical name	Pentasodium triphosphate
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	Identification
Solubility	Freely soluble in water. Insoluble in ethanol
Test for sodium	Passes test
Test for phosphate	Passes test
pH	Between 9,1 and 10,2 (1 % solution)
Purity	Purity
Loss on drying	Anhydrous: Not more than 0,7 % (105 °C, 1 hour) Hexahydrate: Not more than 23,5 % (60 °C, 1 hour, then 105 °C, 4 hours)
Water insoluble matter	Not more than 0,1 %
Higher polyphosphates	Not more than 1 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg

E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE


Synonyms	Pentapotassium tripolyphosphate; Potassium triphosphate; Potassium tripolyphosphate
Definition	Definition
Einecs	237-574-9
Chemical name	Pentapotassium triphosphate; Pentapotassium tripolyphosphate
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	Identification
Solubility	Very soluble in water
Test for potassium	Passes test
Test for phosphate	Passes test
pH	Between 9,2 and 10,5 (1 % solution)
Purity	Purity
Loss on ignition	Not more than 0,4 % (105 °C, 4 hours, then 550 °C, 30 minutes)
Water insoluble matter	Not more than 2 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg

E 452 (i) SODIUM POLYPHOSPHATE

I. SOLUBLE POLYPHOSPHATE


Synonyms	Sodium hexametaphosphate; Sodium tetrapolyphosphate; Graham's salt; Sodium polyphosphates, glassy; Sodium polymetaphosphate; Sodium metaphosphate
Definition	Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (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
Einecs	272-808-3
Chemical name	Sodium polyphosphate
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	Identification
Solubility	Very soluble in water
Test for sodium	Passes test
Test for phosphate	Passes test
pH	Between 3,0 and 9,0 (1 % solution)
Purity	Purity
Loss on ignition	Not more than 1 %
Water insoluble matter	Not more than 0,1 %
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg

II. INSOLUBLE POLYPHOSPHATE


Synonyms	Insoluble sodium 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
Einecs	272-808-3
Chemical name	Sodium polyphosphate
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 68,7 % and not more than 70,0 %
Description	White crystalline powder
Identification	Identification
Solubility	Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides
Test for sodium	Passes test
Test for phosphate	Passes test
pH	About 6,5 (1 in 3 suspension in water)
Purity	Purity
Fluoride	Not more than 10 mg/kg (expressed as fluorine)
Arsenic	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg

E 452 (ii) POTASSIUM POLYPHOSPHATE


Synonyms	Potassium metaphosphate; Potassium polymetaphosphate; Kurrol salt
Definition	Definition
Einecs	232-212-6
Chemical name	Potassium polyphosphate
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
Assay	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	Identification
Solubility	1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate
Test for potassium	Passes test
Test for phosphate	Passes test
pH	Not more than 7,8 (1 % suspension)
Purity	Purity
Loss on ignition	Not more than 2 % (105 °C, 4 hours then 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 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg

E 452(iii) SODIUM CALCIUM POLYPHOSPHATE


Synonyms	Sodium calcium polyphosphate, glassy
Definition	Definition
Einecs	233-782-9
Chemical name	Sodium calcium polyphosphate
Chemical formula	(NaPO3)n CaO where n is typically 5
Molecular weight
Assay	P2O5 content not less than 61 % and not more than 69 % on the ignited basis
Description	White glassy crystals, spheres
Identification	Identification
pH	Approximately 5 to 7 (1 % m/m slurry)
CaO content	7 % - 15 % m/m
Purity	Purity
Fluoride	Not more than 10 mg/kg
Arsenic	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg

E 452 (iv) CALCIUM POLYPHOSPHATE


Synonyms	Calcium metaphosphate; Calcium polymetaphosphate
Definition	Definition
Einecs	236-769-6
Chemical name	Calcium polyphosphate
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
Assay	P2O5 content not less than 71 % and not more than 73 % on the ignited basis
Description	Odourless, colourless crystals or white powder
Identification	Identification
Solubility	Usually sparingly soluble in water. Soluble in acid medium
Test for calcium	Passes test
Test for phosphate	Passes test
CaO content	27 to 29,5 %
Purity	Purity
Loss on ignition	Not more than 2 % (105 °C, 4 hours then 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 1 mg/kg
Cadmium	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg
Mercury	Not more than 1 mg/kg

E 456 POTASSIUM POLYASPARTATE


Synonyms	Synonyms
Definition	Potassium polyaspartate is the potassium salt of polyaspartic acid, produced from L-aspartic acid and potassium hydroxide. The thermic process transforms the aspartic acid in polysuccinimide that is insoluble. Polysuccinimide is treated with potassium hydroxide allowing the opening of the ring and polymerisation of the units. The last step is the spray drying phase, which results in a light tan powder
CAS number	64723-18-8
Chemical name	L-aspartic acid, homopolymer, potassium salt
Chemical formula	[C4H4NO3K]n
Weight average molecular weight	Approximately 5 300 g/mol
Assay	Not less than 98 % on dry weight basis
Particle size	Not less than 45 μm (not more than 1 % in weight of particles of less than 45 μm)
Description	A light brown odourless powder
Identification	Identification
Solubility	Very soluble in water and slightly soluble in organic solvents
pH	7,5-8,5 (40 % aqueous solution)
Purity	Purity
Degree of substitutions	Not less than 91,5 % on dry weight basis
Loss on drying	Not more than 11 % (105 °C,12 hours)
Potassium hydroxide	Not more than 2 %
Aspartic acid	Not more than 1 %
Other impurities	Not more than 0,1 %
Arsenic	Not more than 2,5 mg/kg
Lead	Not more than 1,5 mg/kg
Mercury	Not more than 0,5 mg/kg
Cadmium	Not more than 0,1 mg/kg

E 459 BETA-CYCLODEXTRIN


Synonyms
Definition	Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D-glucopyranosyl units. The product is manufactured by the action of the enzyme cycloglycosyltransferase (CGTase) obtained from Bacillus circulans, Paenibacillus macerans or recombinant Bacillus licheniformis strain SJ1608 on partially hydrolysed starch
Einecs	231-493-2
Chemical name	Cycloheptaamylose
Chemical formula	(C6H10O5)7
Molecular weight	1 135
Assay	Content not less than 98,0 % of (C6H10O5)7 on an anhydrous basis
Description	Virtually odourless white or almost white crystalline solid
Appearance of the aqueous solution	Clear and colourless
Identification	Identification
Solubility	Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol
Specific rotation	[α]D ²⁵ + 160° to + 164° (1 % solution)
pH value:	5,0-8,0 (1 % solution)
Purity	Purity
Water content	Not more than 14 % (Karl Fischer method)
Other cyclodextrins	Not more than 2 % on an anhydrous basis
Solvent residues	Not more than 1 mg/kg of each of toluene and trichloroethylene
Sulphated ash	Not more than 0,1 %
Arsenic	Not more than 1 mg/kg
Lead	Not more than 1 mg/kg

E 460 (i) MICROCRYSTALLINE CELLULOSE, CELLULOSE GEL


Synonyms

Definition	Microcrystalline cellulose is purified, partially depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400

CAS number	9004-34-6

Einecs	232-674-9
Chemical name	Cellulose
Chemical formula	(C6H10O5)n
Molecular weight	About 36 000
Assay	Not less than 97 % calculated as cellulose on the anhydrous basis
Particle size	Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
Description	A fine white or almost white odourless powder
Identification	Identification

Solubility	Insoluble in water, ethanol, ether and dilute mineral acids. Practically insoluble or insoluble in sodium hydroxide solution (concentration: 50 g NaOH/L)

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
Infrared absorption spectroscopy	To be identified
Suspension test	Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-following suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped 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
pH	The pH of the supernatant liquid is between 5,0 and 7,5 (10 % suspension in water)

Purity	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 % (800 ± 25 °C)
Starch	Not detectable To 20 ml of the dispersion obtained in Identification, suspension test, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
Carboxyl groups	Not more than 1 %
Arsenic	Not more than 0,1 mg/kg
Lead	Not more than 0,1 mg/kg
Mercury	Not more than 0,1 mg/kg
Cadmium	Not more than 0,1 mg/kg

E 460 (ii) POWDERED CELLULOSE


Definition	Purified, mechanically disintegrated cellulose prepared by processing alpha-cellulose obtained as a pulp from strains of fibrous plant materials

CAS number	9004-34-6

Einecs	232-674-9
Chemical name	Cellulose; Linear polymer of 1:4 linked glucose residues
Chemical formula	(C6H10O5)n
Molecular weight	(162)n (n is predominantly 1 000 and greater)
Assay	Content not less than 92 %
Particle size	Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
Description	A white, odourless powder
Identification	Identification
Solubility	Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
Suspension test	Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-flowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped 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
pH	The pH of the supernatant liquid is between 5,0 and 7,5 (10 % suspension in water)

Purity	Purity
Loss on drying	Not more than 7 % (105 °C, 3 hours)
Water soluble matter	Not more than 1,0 %
Sulphated ash	Not more than 0,3 % (800 ± 25 °C)
Starch	Not detectable To 20 ml of the dispersion obtained in Identification, suspension test, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
Arsenic	Not more than 0,1 mg/kg
Lead	Not more than 0,3 mg/kg
Mercury	Not more than 0,2 mg/kg
Cadmium	Not more than 0,1 mg/kg

E 461 METHYL CELLULOSE


Synonyms	Cellulose methyl ether
Definition	Methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl groups

CAS number	9004-67-5

Einecs	618-391-7

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	Identification
Solubility	Swelling in water, producing a clear to opalescent, viscous, colloidal dispersion. Insoluble in ethanol, ether and chloroform. Soluble in glacial acetic acid
pH	Not less than 5,0 and not more than 8,0 (1 % colloidal dispersion)
Purity	Purity
Loss on drying	Not more than 10 % (105 °C, 3 hours)
Sulphated ash	Not more than 1,5 % (800 ± 25 °C)
Arsenic	Not more than 0,1 mg/kg
Lead	Not more than 0,1 mg/kg
Mercury	Not more than 0,1 mg/kg
Cadmium	Not more than 0,1 mg/kg

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

CAS number	9004-57-3

Einecs	618-384-9

Chemical name	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
Molecular weight
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	Identification
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
Film forming test	Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of toluene ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml of the solution onto a glass plate and allow the solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable

pH	Neutral to litmus (1 % colloidal dispersion)
Purity	Purity
Loss on drying	Not more than 3 % (105 °C, 2 hours)
Sulphated ash	Not more than 0,4 %
Arsenic	Not more than 0,5 mg/kg
Lead	Not more than 0,5 mg/kg
Mercury	Not more than 0,5 mg/kg
Cadmium	Not more than 0,5 mg/kg

E 463 HYDROXYPROPYL CELLULOSE


Synonyms	Cellulose hydroxypropyl ether
Definition	Hydroxypropylcellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with hydroxypropyl groups

CAS number	9004-64-2

Einecs	618-388-0

Chemical name	Hydroxypropyl 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 — CH2CHOHCH3 — CH2CHO(CH2CHOHCH3)CH3 — CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3
Molecular weight	From about 30 000 to 1 000 000
Assay	Content not more than 80,5 % of hydroxypropoxyl groups (-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis
Description	Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

Identification	Identification
Solubility	Swelling in water, producing a clear to opalescent, viscous, colloidal dispersion. Soluble in ethanol. Insoluble in ether
Gas chromatography	Determine the substituents by gas chromotography
pH	Not less than 5,0 and not more than 8,0 (1 % colloidal dispersion)
Purity	Purity
Loss on drying	Not more than 10 % (105 °C, 3 hours)
Sulphated ash	Not more than 0,5 % determined at 800 ± 25 °C
Propylene chlorohydrins	Not more than 0,1 mg/kg
Arsenic	Not more than 0,5 mg/kg
Lead	Not more than 0,5 mg/kg
Mercury	Not more than 0,5 mg/kg
Cadmium	Not more than 0,5 mg/kg

E 463a LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (L-HPC)


Synonyms	Cellulose hydroxypropyl ether, low substituted
Definition	L-HPC is a low-substituted poly (hydroxypropyl) ether of cellulose. L-HPC is manufactured by partial etherification of the anhydroglucose units of pure cellulose (wood pulp) with propylene oxide/hydroxypropyl groups. The resulting product is then purified, dried and milled to yield low-substituted hydroxypropyl cellulose. L-HPC contains not less than 5,0 % and not more than 16,0 % of hydroxypropoxy groups, calculated on the dried basis. L-HPC differs from hydroxypropyl cellulose (E 463) with respect to the degree of molar substitution with hydroxypropoxy groups of the glucose ring unit (0,2 for L-HPC vs 3,5 for E 463) of the cellulose backbone.
IUPAC name	Cellulose, 2-hydroxypropyl ether (low substituted)
CAS number	9004-64-2

Einecs	618-388-0

Chemical name	Hydroxypropyl ether of cellulose, low-substituted
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 — CH2CHOHCH3 — CH2CHO(CH2CHOHCH3)CH3 — CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3
Molecular weight	From about 30 000 to 150 000 g/mol
Assay	The average number of hydroxypropoxy groups (–OCH2CHOHCH3) corresponds to 0,2 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis
Particle size	by laser diffraction method — Not less than 45 μm (not more than 1 % in weight of particles of less than 45 μm) and not more than 65 μm by size-exclusion chromatography (SEC) — Average (D50) particle size between 47,3 μm and 50,3 μm; D90 value (90 % below given value) between 126,2 μm and 138 μm
Description	Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification	Passes test
Solubility	Insoluble in water; swelling in water. It dissolves in a solution of 10 % sodium hydroxide producing a viscous solution.
Assay	Determination of the degree of molar substitution by gas chromatography

pH	Not less than 5,0 and not more than 7,5 (1 % colloidal dispersion)
Purity
Loss on drying	Not more than 5,0 % (105 °C, 1 hour)
Residue on ignition	Not more than 0,8 % determined at 800 °C ± 25 °C
Propylene chlorohydrins	Not more than 0,1 mg/kg (on an anhydrous basis) (gas chromatography–mass spectrometry (GC–MS))
Arsenic	Not more than 0,5 mg/kg
Lead	Not more than 0,5 mg/kg
Mercury	Not more than 0,5 mg/kg
Cadmium	Not more than 0,15 mg/kg

E 464 HYDROXYPROPYL METHYL CELLULOSE


Synonyms
Definition	Hydroxypropyl methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution

CAS number	9004-65-3

Einecs	618-389-6

Chemical name	2-Hydroxypropyl ether of methylcellulose
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 — CH2CHOHCH3 — CH2CHO (CH2CHOHCH3) CH3 — CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3
Molecular weight	From about 13 000 to 200 000
Assay	Content not less than 19 % and not more than 30 % methoxyl groups (-OCH3) and not less than 3 % and not more than 12 % hydroxypropoxyl groups (-OCH2CHOHCH3), on the anhydrous basis
Description	Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

Identification	Identification
Solubility	Swelling in water, producing a clear to opalescent, viscous, colloidal dispersion. Insoluble in ethanol
Gas chromatography	Determine the substituents by gas chromatography
pH	Not less than 5,0 and not more than 8,0 (1 % colloidal dispersion)
Purity	Purity
Loss on drying	Not more than 10 % (105 °C, 3 hours)
Sulphated ash	Not more than 1,5 % for products with viscosities of 50 mPa.s or above Not more than 3 % for products with viscosities below 50 mPa.s
Propylene chlorohydrins	Not more than 0,1 mg/kg
Arsenic	Not more than 0,1 mg/kg
Lead	Not more than 0,1 mg/kg
Mercury	Not more than 0,1 mg/kg
Cadmium	Not more than 0,1 mg/kg

E 465 ETHYL METHYL CELLULOSE


Synonyms	Methylethylcellulose
Definition	Ethyl methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl and ethyl groups

CAS number	9004-59-5. The CAS number 9004-69-7 has also been assigned to ethyl methyl cellulose

Einecs
Chemical name	Ethyl 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 — CH2CH3
Molecular weight	From about 30 000 to 40 000
Assay	Content on the anhydrous basis not less than 3,5 % and not more than 6,5 % of methoxyl groups (-OCH3) and not less than 14,5 % and not more than 19 % of ethoxyl groups (-OCH2CH3), and not less than 13,2 % and not more than 19,6 % of total alkoxyl groups, calculated as methoxyl
Description	Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

Identification	Identification
Solubility	Swelling in water, producing a clear to opalescent, viscous, colloidal dispersion. Soluble in ethanol. Insoluble in ether
pH	Not less than 5,0 and not more than 8,0 (1 % colloidal dispersion)
Purity	Purity
Loss on drying	Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 °C to constant weight)
Sulphated ash	Not more than 0,6 %
Arsenic	Not more than 0,1 mg/kg
Lead	Not more than 0,1 mg/kg
Mercury	Not more than 0,1 mg/kg
Cadmium	Not more than 0,1 mg/kg

E 466 SODIUM CARBOXY METHYL CELLULOSE, CELLULOSE GUM


Synonyms	NaCMC; Sodium CMC
Definition	Sodium carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from strains of fibrous plant material

CAS number	9004-32-4

Einecs	618-378-6

Chemical name	Sodium salt of the carboxymethyl 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 — CH2COONa — CH2COOH
Molecular weight	Higher than approximately 17 000 (degree of polymerisation approximately 100)
Assay	Content on the anhydrous basis not less than 99,5 %
Description	Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

Identification	Identification
Solubility	Yields a viscous colloidal dispersion in water. Insoluble in ethanol
Foam test	A 0,1 % dispersion of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers)
Precipitate formation	To 5 ml of a 0,5 % dispersion of the sample, add 5 ml of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth)
Colour reaction	Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear dispersion is produced, and use the dispersion for the following test: To 1 mg of the sample, diluted with an equal volume of water, in a small test tube, add 5 drops of 1-naphthol solution. Incline the test tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
pH	Not less than 5,0 and not more than 8,5 (1 % colloidal dispersion)
Purity	Purity
Degree of substitution	Not less than 0,2 and not more than 1,5 carboxymethyl groups (-CH2COOH) per anhydroglucose unit
Loss on drying	Not more than 12 % (105 °C to constant weight)
Arsenic	Not more than 0,1 mg/kg
Lead	Not more than 0,1 mg/kg
Mercury	Not more than 0,1 mg/kg
Cadmium	Not more than 0,1 mg/kg
Total glycolate	Not more than 0,4 %, calculated as sodium glycolate on the anhydrous basis
Sodium	Not more than 12,4 % on the anhydrous basis

E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE, CROSS-LINKED CELLULOSE GUM


Synonyms	Cross-linked carboxymethyl cellulose; Cross-linked CMC; Cross-linked sodium CMC;
Definition	Cross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated cellulose

CAS number	74811-65-7

Einecs	629-739-2

Chemical name	Sodium salt of the cross-linked carboxymethyl ether cellulose
Chemical formula	The polymers containing substituted anhydroglucose units with the general formula: C6H7O2(OR1)(OR2)(OR3) where R1, R2 and R3 may be any of the following: — H — CH2COONa — CH2COOH
Molecular weight
Assay
Description	Slightly hygroscopic, white to off white, odourless powder
Identification	Identification
Precipitate formation	Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene blue and allow to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass
Colour reaction	Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test tube, add 1 ml water and 0,05 ml of freshly prepared 40 g/l solution of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of sulphuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface
Test for sodium	Passes test

pH	Not less than 5,0 and not more than 7,0 (1 % dispersion)
Purity	Purity
Loss on drying	Not more than 6 % (105 °C, 3 hours)
Water soluble matter	Not more than 10 %
Degree of substitution	Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit
Sodium content	Not more than 12,4 % on anhydrous basis
Arsenic	Not more than 0,2 mg/kg
Lead	Not more than 0,1 mg/kg
Mercury	Not more than 0,1 mg/kg
Cadmium	Not more than 0,1 mg/kg

E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE, ENZYMATICALLY HYDROLISED CELLULOSE GUM


Synonyms	Sodium carboxymethyl cellulose, enzymatically hydrolysed
Definition	Enzymatically hydrolysed carboxymethylcellulose is obtained from carboxymethylcellulose by enzymatic digestion with a cellulase produced by Trichoderma longibrachiatum (formerly T. reesei)
Einecs
Chemical name	Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed
Chemical formula	Sodium salts of polymers containing substituted anhydroglucose units with the general formula: [C6H7O2(OH)x(OCH2COONa)y]n where n is the degree of polymerisation x = 1,50 to 2,80 y = 0,2 to 1,50 x + y = 3,0 (y = degree of substitution)
Molecular weight	178,14 where y = 0,20 282,18 where y = 1,50 Macromolecules: Not less than 800 (n about 4)
Assay	Not less than 99,5 %, including mono- and disaccharides, on the dried basis
Description	White or slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous powder

Identification	Identification
Solubility	Soluble in water, insoluble in ethanol
Foam test	Vigorously shake a 0,1 % dispersion of the sample. No layer of foam appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and natural gums
Precipitate formation	To 5 ml of a 0,5 % dispersion of the sample, add 5 ml of a 5 % solution of copper or aluminium sulphate. A precipitate appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from gelatine, carob bean gum and tragacanth gum
Colour reaction	Add 0,5 g of the powdered sample to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear dispersion is produced. Dilute 1 ml of the dispersion with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
Viscosity (60 % solids)	Not less than 2 500 kgm– 1s– 1 at 25 °C corresponding to an average molecule weight of 5 000 Da
pH	Not less than 6,0 and not more than 8,5 (1 % colloidal dispersion)
Purity	Purity
Loss on drying	Not more than 12 % (105 °C to constant weight)
Degree of substitution	Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit on the dried basis
Sodium chloride and sodium glycolate	Not more than 0,5 % singly or in combination
Residual enzyme activity	Passes test. No change in viscosity of test dispersion occurs, which indicates hydrolysis of the sodium carboxymethyl cellulose
Arsenic	Not more than 0,1 mg/kg
Lead	Not more than 0,1 mg/kg
Mercury	Not more than 0,1 mg/kg
Cadmium	Not more than 0,1 mg/kg

E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDS


Synonyms
Definition	Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids.
Einecs
Chemical name
Chemical formula
Molecular weight
Assay	Content on the anhydrous basis not less than 95 % (105 °C till a constant weight)
Description	White or creamy white light powders, flakes or semi-solids
Identification	Identification
Solubility	Sodium and potassium salts: soluble in water and ethanol. Calcium salts: insoluble in water, ethanol and ether
Test for cations	Passes test
Test for fatty acids	Passes test
Purity	Purity
Sodium	Not less than 9 % and not more than 14 % expressed as Na2O
Potassium	Not less than 13 % and not more than 21,5 % expressed as K2O
Calcium	Not less than 8,5 % and not more than 13 % expressed as CaO
Unsaponifiable matter	Not more than 2 %
Free fatty acids	Not more than 3 % estimated as oleic acid
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Free alkali	Not more than 0,1 % expressed as NaOH
Matter insoluble in alcohol	Not more than 0,2 % (sodium and potassium salts only)

E 470b MAGNESIUM SALTS OF FATTY ACIDS


Synonyms
Definition	Magnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids
Einecs
Chemical name
Chemical formula
Molecular weight
Assay	Content on the anhydrous basis not less than 95 % (105 °C till a constant weight)
Description	White or creamy-white light powders, flakes or semi-solids
Identification	Identification
Solubility	Insoluble in water, partially soluble in ethanol and ether
Test for magnesium	Passes test
Test for fatty acids	Passes test
Purity	Purity
Magnesium	Not less than 6,5 % and not more than 11 % expressed as MgO
Free alkali	Not more than 0,1 % expressed as MgO
Unsaponifiable matter	Not more than 2 %
Free fatty acids	Not more than 3 % estimated as oleic acid
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg

E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS


Synonyms
Definition	Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and tri-esters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol. Glycerol used for the manufacture of mono- and diglycerides of fatty acids should comply with the specifications for E 422. E 471 shall be produced from fats and oils complying with Union food safety requirements for edible fats and oils.
Einecs
Chemical name
Chemical formula
Molecular weight
Assay	Content of mono- and di-esters: not less than 70 % Content of erucic acid, including erucic acid bound in the mono/diglyceride: Not more than 0,2 % (only if added to food for infants and young children) Not more than 0,5 % (for all uses except for foods intended for infants and young children)
Description	The product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads.
Identification
Infrared absorption spectrum	Characteristic of a partial fatty acid ester of a polyol
Test for glycerol	Passes test
Test for fatty acids	Passes test
Solubility	Insoluble in water, soluble in ethanol and toluene at 50 °C

Purity
Water content	Not more than 2 % (Karl Fischer method)
Acid value	Not more than 6
Free glycerol	Not more than 7 %
Polyglycerols	Not more than 4 % diglycerol and not more than 1 % higher polyglycerols both based on total glycerol content
Arsenic	Not more than 0,1 mg/kg
Lead	Not more than 0,1 mg/kg
Mercury	Not more than 0,1 mg/kg
Cadmium	Not more than 0,1 mg/kg
Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD	Not more than 0,75 mg/kg (only if added to food for infants and young children) Not more than 2,5 mg/kg (for all uses except for foods intended for infants and young children)
Glycidyl esters of fatty acids, expressed as glycidol	From 30 July 2023 until 30 January 2024, not more than 5 mg/kg if added to food for infants and young children) and not more than 10 mg/kg for all other uses. From 30 January 2024, not more than 5 mg/kg for all uses.
Total glycerol	Not less than 16 % and not more than 33 %
Sulphated ash	Not more than 0,5 % determined at 800 ± 25 °C
Soap	—

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

E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS


Synonyms	Acetic acid esters of mono- and diglycerides; Acetoglycerides; Acetylated mono- and diglycerides; Acetic and fatty acid esters of glycerol
Definition	Esters of glycerol with acetic and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free acetic acid and free glycerides
Einecs
Chemical name
Chemical formula
Molecular weight
Assay
Description	Clear, mobile liquids to solids, from white to pale yellow in colour
Identification	Identification
Test for glycerol	Passes test
Test for fatty acids	Passes test
Test for acetic acid	Passes test
Solubility	Insoluble in water. Soluble in ethanol
Purity	Purity
Acids other than acetic and fatty acids	Less than 1 %
Free glycerol	Not more than 2 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Total acetic acid	Not less than 9 % and not more than 32 %
Free fatty acids (and acetic acid)	Not more than 3 % estimated as oleic acid
Total glycerol	Not less than 14 % and not more than 31 %
Sulphated ash	Not more than 0,5 % determined at 800 ± 25 °C

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

E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS


Synonyms	Lactic acid esters of mono- and diglycerides; Lactoglycerides; Mono- and diglycerides of fatty acids esterified with lactic acid
Definition	Esters of glycerol with lactic acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides
Description	Clear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colour
Identification	Identification
Test for glycerol,	Passes test
Test for fatty acids	Passes test
Test for lactic acid	Passes test
Solubility	Insoluble in cold water but dispersible in hot water
Purity	Purity
Acids other than lactic and fatty acids	Less than 1 %
Free glycerol	Not more than 2 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg
Mercury	Not more than 1 mg/kg
Cadmium	Not more than 1 mg/kg
Total lactic acid	Not less than 13 % and not more than 45 %
Free fatty acids (and lactic acid)	Not more than 3 % estimated as oleic acid
Total glycerol	Not less than 13 % and not more than 30 %
Sulphated ash	Not more than 0,5 % (800 ± 25 °C)

E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

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