Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweetenersText with EEA relevance (Codified version)

Den Europæiske UnionDirektiv2008

European Union

Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance) (Codified version) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption OJ L 40, 11.2.1989, p. 27. , and in particular Article 3(3)(a) thereof, Whereas: (1) Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners OJ L 339, 30.12.1996, p. 1. has been substantially amended several times See Annex II, part A. . In the interests of clarity and rationality the said Directive should be codified. (2) It is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners OJ L 61, 18.3.1995, p. 1. . (3) It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). (4) Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health. (6) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, part B, HAS ADOPTED THIS DIRECTIVE:

Article 1

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 Annex I to this Directive.

Article 2

Directive 96/77/EC, as amended by the Directives listed in Annex II, part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law set out in Annex II, part B. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 3

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

Article 4

This Directive is addressed to the Member States. Done at Brussels, 27 August 2008. For the Commission The President José Manuel Barroso

Annex

ANNEX I Ethylene oxide may not be used for sterilising purposes in food additives. E 170 (i) CALCIUM CARBONATE Purity criteria for this additive are the same as set out for this additive in the Annex to Commission Directive 95/45/EC OJ L 226, 22.9.1995, p. 1. . E 200 SORBIC ACID DefinitionChemical nameSorbic acidTrans, trans-2,4-hexadienoic acidEinecs203-768-7Chemical formulaC6H8O2Molecular weight112,12AssayContent not less than 99 % on the anhydrous basisDescriptionColourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 oCIdentification A. Melting range Between 133 oC and 135 oC, after vacuum drying for four hours in a sulphuric acid desiccator B. Spectrometry An isopropanol solution (1 in 4000000) shows absorbance maximum at 254 ± 2 nm C. Positive test for double bonds D. Sublimation point 80 oCPurityWater contentNot more than 0,5 % (Karl Fischer method)Sulphated ashNot more than 0,2 %AldehydesNot more than 0,1 % (as formaldehyde)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 202 POTASSIUM SORBATE DefinitionChemical namePotassium sorbatePotassium (E, E)-2,4-hexadienoatePotassium salt of trans, trans 2,4-hexadienoic acidEinecs246-376-1Chemical formulaC6H7O2KMolecular weight150,22AssayContent not less than 99 % on the dried basis DescriptionWhite crystalline powder showing no change in colour after heating for 90 minutes at 105 oCIdentification A. Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator B. Positive tests for potassium and for double bonds PurityLoss on dryingNot more than 1,0 % (105 oC, 3h)Acidity or alkalinityNot more than about 1,0 % (as sorbic acid or K2CO3)AldehydesNot more than 0,1 %, calculated as formaldehydeArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 203 CALCIUM SORBATE DefinitionChemical nameCalcium sorbateCalcium salts of trans, trans-2,4-hexadienoic acidEinecs231-321-6Chemical formulaC12H14O4CaMolecular weight262,32AssayContent not less than 98 % on the dried basisDescriptionFine white crystalline powder not showing any change in colour after heating at 105 oC for 90 minutesIdentification A. Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator B. Positive tests for calcium and for double bonds PurityLoss on dryingNot more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccatorAldehydesNot more than 0,1 % (as formaldehyde)FluorideNot more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 210 BENZOIC ACID Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluable starch) with 5 ml of water; to the resulting paste add a sufficient quantity of water to give a total volume of 100 ml, stirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be freshly prepared.

Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl2·6H2O in a sufficient quantity of a mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl2·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl2·6H2O per ml. Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl3·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of FeCl3·6H2O per ml. Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO4·5H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 62,4 mg of CuSO4·5H2O per ml. DefinitionChemical nameBenzoic acidBenzenecarboxylic acidPhenylcarboxylic acidEinecs200-618-2Chemical formulaC7H6O2Molecular weight122,12AssayContent not less than 99,5 % on the anhydrous basisDescriptionWhite crystalline powderIdentification A. Melting range 121,5 oC to 123,5 oC B. Positive sublimation test and test for benzoate PurityLoss on dryingNot more than 0,5 % after drying for three hours over sulphuric acidpHAbout 4 (solution in water)Sulphated ashNot more than 0,05 %Chlorinated organic compoundsNot more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acidReadily oxidisable substancesAdd 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 requiredReadily carbonisable substancesA 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 waterPolycyclic acidsOn fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg

E 211 SODIUM BENZOATE DefinitionChemical nameSodium benzoateSodium salt of benzenecarboxylic acidSodium salt of phenylcarboxylic acidEinecs208-534-8Chemical formulaC7H5O2NaMolecular weight144,11AssayNot less than 99 % of C7H5O2Na, after drying at 105 oC for four hoursDescriptionA white, almost odourless, crystalline powder or granulesIdentification 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 recrystallised 121,5 oC to 123,5 oC, after drying in a sulphuric acid desiccator C. Positive tests for benzoate and for sodium PurityLoss on dryingNot more than 1,5 % after drying at 105 oC for four hoursReadily oxidisable substancesAdd 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 requiredPolycyclic acidsOn fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acidChlorinated organic compoundsNot more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acidDegree of acidity or alkalinityNeutralisation 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 HClArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 212 POTASSIUM BENZOATE DefinitionChemical namePotassium benzoatePotassium salt of benzenecarboxylic acidPotassium salt of phenylcarboxylic acidEinecs209-481-3Chemical formulaC7H5KO2·3H2OMolecular weight214,27AssayContent not less than 99 % C7H5KO2 after drying at 105 oC to constant weightDescriptionWhite crystalline powder Identification A. Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator B. Positive tests for benzoate and for potassium PurityLoss on dryingNot more than 26,5 %, determined by drying at 105 oCChlorinated organic compoundsNot more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acidReadily oxidisable substancesAdd 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 requiredReadily carbonisable substancesA 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 waterPolycyclic acidsOn fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acidDegree of acidity or alkalinityNeutralisation 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 HClArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg

E 213 CALCIUM BENZOATE SynonymsMonocalcium benzoateDefinitionChemical nameCalcium benzoateCalcium dibenzoateEinecs218-235-4Chemical formulaAnhydrous:C14H10O4CaMonohydrate:C14H10O4Ca· H2OTrihydrate:C14H10O4Ca· 3H2OMolecular weightAnhydrous:282,31Monohydrate:300,32Trihydrate:336,36AssayContent not less than 99 % after drying at 105 oCDescriptionWhite or colourless crystals, or white powderIdentification A. Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator B. Positive tests for benzoate and for calcium PurityLoss on dryingNot more than 17,5 % determined by drying at 105 oC to constant weightWater insoluble matterNot more than 0,3 %Chlorinated organic compoundsNot more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acidsReadily oxidisable substancesAdd 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 requiredReadily carbonisable substancesCold 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 waterPolycyclic acidsOn fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acidDegree of acidity or alkalinityNeutralisation 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 HClFluorideNot more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 214 ETHYL p-HYDROXYBENZOATE SynonymsEthylparabenEthyl p-oxybenzoateDefinitionChemical nameEthyl-p-hydroxybenzoateEthyl ester of p-hydroxybenzoic acidEinecs204-399-4Chemical formulaC9H10O3Molecular weight166,8AssayContent not less than 99,5 % after drying for two hours at 80 oCDescriptionAlmost odourless, small, colourless crystals or a white, crystalline powderIdentification A. Melting range 115 oC to 118 oC B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 oC to 217 oC, after vacuum drying in a sulphuric acid desiccator C. Positive test for alcohol PurityLoss on dryingNot more than 0,5 % after drying for two hours at 80 oCSulphated ashNot more than 0,05 %p-Hydroxybenzoic acid and salicylic acidNot more than 0,35 % expressed as p-hydroxybenzoic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kg MercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg

E 215 SODIUM ETHYL p-HYDROXYBENZOATE DefinitionChemical nameSodium ethyl p-hydroxybenzoateSodium compound of the ethyl ester of p-hydroxybenzoic acidEinecs252-487-6Chemical formulaC9H9O3NaMolecular weight188,8AssayContent of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basisDescriptionWhite, crystalline hygroscopic powderIdentification A. Melting range 115 oC to 118 oC, 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 oC to 217 oC C. Positive test for sodium D. pH of a 0,1 % aqueous solution must be between 9,9 and 10,3 PurityLoss on dryingNot more than 5 %, determined by vacuum drying in a sulphuric acid desiccatorSulphated ash37 to 39 %p-Hydroxybenzoic acid and salicylic acidNot more than 0,35 % expressed as p-hydroxybenzoic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 218 METHYL p-HYDROXYBENZOATE SynonymsMethylparabenMethyl-p-oxybenzoateDefinitionChemical nameMethyl p-hydroxybenzoateMethyl ester of p-hydroxybenzoic acidEinecs243-171-5Chemical formulaC8H8O3Molecular weight152,15AssayContent not less than 99 % after drying for two hours at 80 oCDescriptionAlmost odourless, small colourless crystals or white crystalline powder Identification A. Melting range 125 oC to 128 oC B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC after drying for two hours at 80 oCPurityLoss on dryingNot more than 0,5 %, after drying for two hours at 80 oCSulphated ashNot more than 0,05 %p-Hydroxybenzoic acid and salicylic acidNot more than 0,35 % expressed as p-hydroxybenzoic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 219 SODIUM METHYL p-HYDROXYBENZOATE DefinitionChemical nameSodium methyl p-hydroxybenzoateSodium compound of the methylester of p-hydroxybenzoic acidChemical formulaC8H7O3NaMolecular weight174,15AssayContent not less than 99,5 % on the anhydrous basisDescriptionWhite, hygroscopic powderIdentification 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 oC for two hours, have a melting range of 125 oC to 128 oC 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 PurityWater contentNot more than 5 % (Karl Fischer method)Sulphated ash40 % to 44,5 % on the anhydrous basisp-Hydroxybenzoic acid and salicylic acidNot more than 0,35 % expressed as p-hydroxybenzoic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 220 SULPHUR DIOXIDE DefinitionChemical nameSulphur dioxideSulphurous acid anhydrideEinecs231-195-2Chemical formulaSO2Molecular weight64,07AssayContent not less than 99 %DescriptionColourless, non-flammable gas with strong pungent suffocating odourIdentification

A. Positive test for sulphurous substances PurityWater contentNot more than 0,05 %Non-volatile residueNot more than 0,01 %Sulphur trioxideNot more than 0,1 %SeleniumNot more than 10 mg/kgOther gases not normally present in the airNo traceArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 221 SODIUM SULPHITE DefinitionChemical nameSodium sulphite (anhydrous or heptahydrate)Einecs231-821-4Chemical formulaAnhydrous:Na2SO3Heptahydrate:Na2SO37H2OMolecular weightAnhydrous:126,04Heptahydrate:252,16AssayAnhydrous:Not less than 95 % of Na2SO3 and not less than 48 % of SO2Heptahydrate:Not less than 48 % of Na2SO3 and not less than 24 % of SO2DescriptionWhite crystalline powder or colourless crystalsIdentification 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 PurityThiosulphateNot more than 0,1 % based on the SO2 contentIronNot more than 50 mg/kg based on the SO2 contentSeleniumNot more than 10 mg/kg based on the SO2 contentArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 222 SODIUM BISULPHITE DefinitionChemical nameSodium bisulphiteSodium hydrogen sulphiteEinecs231-921-4Chemical formulaNaHSO3 in aqueous solutionMolecular weight104,06AssayContent not less than 32 % w/w NaHSO3DescriptionA clear, colourless to yellow solutionIdentification A. Positive tests for sulphite and for sodium B. pH of a 10 % aqueous solution between 2,5 and 5,5 PurityIronNot more than 50 mg/kg of Na2SO3 based on the SO2 contentSeleniumNot more than 10 mg/kg based on the SO2 contentArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 223 SODIUM METABISULPHITE SynonymsPyrosulphiteSodium pyrosulphiteDefinitionChemical nameSodium disulphiteDisodium pentaoxodisulphateEinecs231-673-0Chemical formulaNa2S2O5Molecular weight190,11AssayContent not less than 95 % Na2S2O5 and not less than 64 % of SO2DescriptionWhite crystals or crystalline powderIdentification A. Positive tests for sulphite and for sodium B. pH of a 10 % aqueous solution between 4,0 and 5,5 PurityThiosulphateNot more than 0,1 % based on the SO2 contentIronNot more than 50 mg/kg based on the SO2 contentSeleniumNot more than 10 mg/kg based on the SO2 contentArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 224 POTASSIUM METABISULPHITE SynonymsPotassium pyrosulphiteDefinitionChemical namePotassium disulphitePotassium pentaoxo disulphateEinecs240-795-3Chemical formulaK2S2O5Molecular weight222,33AssayContent not less than 90 % of K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphateDescriptionColourless crystals or white crystalline powderIdentification A. Positive tests for sulphite and for potassium

PurityThiosulphateNot more than 0,1 % based on the SO2 contentIronNot more than 50 mg/kg based on the SO2 contentSeleniumNot more than 10 mg/kg based on the SO2 contentArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 226 CALCIUM SULPHITE DefinitionChemical nameCalcium sulphiteEinecs218-235-4Chemical formulaCaSO3·2H2OMolecular weight156,17AssayContent not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2DescriptionWhite crystals or white crystalline powderIdentification A. Positive tests for sulphite and for calcium PurityIronNot more than 50 mg/kg based on the SO2 contentSeleniumNot more than 10 mg/kg based on the SO2 contentArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 227 CALCIUM BISULPHITE DefinitionChemical nameCalcium bisulphiteCalcium hydrogen sulphiteEinecs237-423-7Chemical formulaCa(HSO3)2Molecular weight202,22Assay6 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]DescriptionClear greenish-yellow aqueous solution having a distinct odour of sulphur dioxideIdentification A. Positive tests for sulphite and for calcium PurityIronNot more than 50 mg/kg based on the SO2 contentSeleniumNot more than 10 mg/kg based on the SO2 contentArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 228 POTASSIUM BISULPHITE DefinitionChemical namePotassium bisulphitePotassium hydrogen sulphiteEinecs231-870-1Chemical formulaKHSO3 in aqueous solutionMolecular weight120,17AssayContent not less than 280 g KHSO3 per litre (or 150 g SO2 per litre)DescriptionClear colourless aqueous solutionIdentification A. Positive tests for sulphite and for potassium PurityIronNot more than 50 mg/kg based on the SO2 contentSeleniumNot more than 10 mg/kg based on the SO2 content ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 230 BIPHENYL SynonymsDiphenylDefinitionChemical name1,1′-biphenylPhenylbenzeneEinecs202-163-5Chemical formulaC12H10Molecular weight154,20AssayContent not less than 99,8 %DescriptionWhite or pale yellow to amber crystalline solid having a characteristic odourIdentification A. Melting range 68,5 oC to 70,5 oC B. Distillation range It distils completely within a 2,5 oC range between 252,5 oC and 257,5 oCPurityBenzeneNot more than 10 mg/kgAromatic aminesNot more than 2 mg/kg (as aniline)Phenol derivativesNot more than 5 mg/kg (as phenol)Readily carbonisable substancesCold 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 waterTerphenyl and higher polyphenyl derivativesNot more than 0,2 %Polycyclic aromatic hydrocarbonsAbsentArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg

E 231 ORTHOPHENYLPHENOL SynonymsOrthoxenolDefinitionChemical name(1,1'-Biphenyl)-2-ol2-Hydroxydiphenylo-HydroxydiphenylEinecs201-993-5Chemical formulaC12H10OMolecular weight170,20AssayContent not less than 99 %DescriptionWhite or slightly yellowish crystalline powder Identification A. Melting range 56 oC to 58 oC B. Positive test for phenolate An ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solutionPuritySulphated ashNot more than 0,05 %Diphenyl etherNot more than 0,3 %p-PhenylphenolNot more than 0,1 %1-NaphtholNot more than 0,01 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 232 SODIUM ORTHOPHENYLPHENOL SynonymsSodium orthophenylphenateSodium salt ofo-phenylphenolDefinitionChemical nameSodium orthophenylphenolEinecs205-055-6Chemical formulaC12H9ONa· 4H2OMolecular weight264,26AssayContent not less than 97 % of C12H9ONa· 4H2ODescriptionWhite or slightly yellowish crystalline powderIdentification A. Positive tests for phenolate and for sodium B. Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56 oC to 58 oC after drying in a sulphuric acid desiccator C. pH of a 2 % aqueous solution must be between 11,1 and 11,8 PurityDiphenyletherNot more than 0,3 %p-phenylphenolNot more than 0,1 %1-naphtholNot more than 0,01 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 233 THIABENDAZOLE DefinitionChemical name4-(2-benzimidazolyl)thiazole2-(4-thiazolyl)-1H-benzimidazole Einecs205-725-8Chemical formulaC10H7N3SMolecular weight201,26AssayContent not less than 98 % on the anhydrous basisDescriptionWhite, or almost white, odourless powderIdentification A. Melting range 296 oC to 303 oC B. Spectrometry Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nmE 1%1cmat 302 nm ± 2 nm: approximately 1230E 1%1cmat 258 nm ± 2 nm: approximately 200E 1%1cmat 243 nm ± 2 nm: approximately 620Ratio of absorption 243 nm/302 nm = 0,47 to 0,53Ratio of absorption 258 nm/302 nm = 0,14 to 0,18PurityWater contentNot more than 0,5 % (Karl Fischer method)Sulphated ashNot more than 0,2 %SeleniumNot more than 3 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 234 NISIN DefinitionNisin consists of several closely related polypeptides produced by natural strains of Streptococcus lactis, Lancefield group NEinecs215-807-5Chemical formulaC143H230N42O37S7Molecular weight3 354 ,12AssayNisin 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 %DescriptionWhite powderPurityLoss on dryingNot more than 3 % when dried to constant weight at 102 oC to 103 oCArsenicNot more than 1 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg

E 235 NATAMYCIN SynonymsPimaricinDefinitionNatamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis Einecs231-683-5Chemical formulaC33H47O13NMolecular weight665,74AssayContent not less than 95 % on the anhydrous basisDescriptionWhite to creamy-white crystalline powderIdentification 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 neutralised mixture of 20 parts dimethylformamide and 80 parts of water) D. Specific rotation [α]D20 = + 250o to + 295o (a 1 % w/v solution in glacial acetic acid, at 20 oC and calculated with reference to the dried material)PurityLoss on dryingNot more than 8 % (over P2O5, in vacuum at 60 oC to constant weight)Sulphated ashNot more than 0,5 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgMicrobiological criteria: total viable countNot more than 100/g E 239 HEXAMETHYLENE TETRAMINE SynonymsHexamineMethenamineDefinitionChemical name1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramineEinecs202-905-8Chemical formulaC6H12N4Molecular weight140,19AssayContent not less than 99 % on the anhydrous basisDescriptionColourless or white crystalline powderIdentification A. Positive tests for formaldehyde and for ammonia B. Sublimation point approximately 260 oC PurityLoss on dryingNot more than 0,5 % after drying at 105 oC in vacuum over P2O5 for two hoursSulphated ashNot more than 0,05 %SulphatesNot more than 0,005 % expressed as SO4 ChloridesNot more than 0,005 % expressed as ClAmmonium saltsNot detectableArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 242 DIMETHYL DICARBONATE SynonymsDMDCDimethyl pyrocarbonateDefinitionChemical nameDimethyl dicarbonatePyrocarbonic acid dimethyl esterEinecs224-859-8Chemical formulaC4H6O5Molecular weight134,09AssayContent not less than 99,8 %DescriptionColourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestionIdentification A. Decomposition After dilution positive tests for CO2 and methanol B. Melting point 17 oCBoiling point172 oC with decomposition C. Density 20 oC Approximately 1,25 g/cm3 D. Infrared spectrum Maxima at 1156 and 1832 cm- 1PurityDimethyl carbonateNot more than 0,2 %Chlorine, totalNot more than 3 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg

E 249 POTASSIUM NITRITE When labelled for food use, nitrite may only be sold in a mixture with salt or a salt substitute. DefinitionChemical namePotassium nitriteEinecs231-832-4Chemical formulaKNO2Molecular weight85,11AssayContent not less than 95 % on the anhydrous basisDescriptionWhite 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 9,0PurityLoss on dryingNot more than 3 % after drying for four hours over silica gelArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 250 SODIUM NITRITE When labelled for food use, nitrite may only be sold in a mixture with salt or a salt substitute. DefinitionChemical nameSodium nitriteEinecs231-555-9Chemical formulaNaNO2Molecular weight69,00AssayContent not less than 97 % on the anhydrous basisDescriptionWhite crystalline powder or yellowish lumpsIdentification A. Positive tests for nitrite and for sodium PurityLoss on dryingNot more than 0,25 % after drying over silica gel for four hoursArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 251 SODIUM NITRATE

SOLID SODIUM NITRATE SynonymsChile saltpetreCubic or soda nitreDefinitionChemical nameSodium nitrateEinecs231-554-3Chemical formulaNaNO3Molecular weight85,00AssayContent not less than 99 % after dryingDescriptionWhite 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 more than 8,3PurityLoss on dryingNot more than 2 % after drying at 105 oC for four hoursNitritesNot more than 30 mg/kg expressed as NaNO2ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 251 SODIUM NITRATE
LIQUID SODIUM NITRATE DefinitionLiquid 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 nameSodium nitrateEinecs231-554-3Chemical formulaNaNO3Molecular weight85,00AssayContent between 33,5 % and 40,0 % of NaNO3DescriptionClear colourless liquidIdentification A. Positive tests for nitrate and for sodium B. pH Not less than 1,5 and not more than 3,5PurityFree nitric acidNot more than 0,01 %NitritesNot more than 10 mg/kg expressed as NaNO2ArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 0,3 mg/kgThis specification refers to a 35 % aqueous solution E 252 POTASSIUM NITRATE Synonyms Chile saltpetre Cubic or soda nitre DefinitionChemical namePotassium nitrateEinecs231-818-8Chemical formulaKNO3Molecular weight101,11AssayContent not less than 99 % on the anhydrous basis

DescriptionWhite crystalline powder or transparent prisms having a cooling, saline, pungent tasteIdentification A. Positive tests for nitrate and for potassium B. pH of a 5 % solution Not less than 4,5 and not more than 8,5PurityLoss on dryingNot more than 1 % after drying at 105 oC for four hoursNitritesNot more than 20 mg/kg expressed as KNO2ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 260 ACETIC ACID DefinitionChemical nameAcetic acidEthanoic acidEinecs200-580-7Chemical formulaC2H4O2Molecular weight60,05AssayContent not less than 99,8 %DescriptionClear, colourless liquid having a pungent, characteristic odourIdentification A. Boiling point 118 oC 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 oCPurityNon-volatile residueNot more than 100 mg/kgFormic acid, formates and other oxidisable substancesNot more than 1000 mg/kg expressed as formic acidReadily oxidisable substancesDilute 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 minutesArsenicNot more than 1 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 261 POTASSIUM ACETATE DefinitionChemical namePotassium acetateEinecs204-822-2Chemical formulaC2H3O2KMolecular weight98,14 AssayContent not less than 99 % on the anhydrous basisDescriptionColourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odourIdentification 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 PurityLoss on dryingNot more than 8 % after drying at 150 oC for two hoursFormic acid, formates and other oxidisable substancesNot more than 1000 mg/kg expressed as formic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 262 (i) SODIUM ACETATE DefinitionChemical nameSodium acetateEinecs204-823-8Chemical formulaC2H3NaO2·nH2O (n = 0 or 3)Molecular weightAnhydrous:82,03Trihydrate:136,08AssayContent (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basisDescriptionAnhydrous:White, odourless, granular, hygroscopic powderTrihydrate:Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry airIdentification 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 PurityLoss on dryingAnhydrous:Not more than 2 % (120 oC, 4 hours)Trihydrate:Between 36 and 42 % (120 oC, 4 hours)Formic acid, formates and other oxidisable substancesNot more than 1000 mg/kg expressed as formic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg

E 262 (ii) SODIUM DIACETATE DefinitionSodium diacetate is a molecular compound of sodium acetate and acetic acidChemical nameSodium hydrogen diacetate Einecs204-814-9Chemical formulaC4H7NaO4·nH2O (n = 0 or 3)Molecular weight142,09 (anhydrous)AssayContent 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetateDescriptionWhite, hygroscopic crystalline solid with an acetic odourIdentification 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 PurityWater contentNot more than 2 % (Karl Fischer method)Formic acid, formates and other oxidisable substancesNot more than 1000 mg/kg expressed as formic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 263 CALCIUM ACETATE DefinitionChemical nameCalcium acetateEinecs200-540-9Chemical formulaAnhydrous:C4H6O4CaMonohydrate:C4H6O4Ca· H2OMolecular weightAnhydrous:158,17Monohydrate:176,18AssayContent not less than 98 % on the anhydrous basisDescriptionAnhydrous 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 powderIdentification 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 PurityLoss on dryingNot more than 11 % after drying (155 oC to constant weight, for the monohydrate)Water insoluble matterNot more than 0,3 %Formic acid, formates and other oxidisable substancesNot more than 1000 mg/kg expressed as formic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 270 LACTIC ACID DefinitionChemical nameLactic acid2-Hydroxypropionic acid1-Hydroxyethane-1-carboxylic acidEinecs200-018-0Chemical formulaC3H6O3Molecular weight90,08AssayContent not less than 76 % and not more than 84 %DescriptionColourless 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 PuritySulphated ashNot more than 0,1 %ChlorideNot more than 0,2 %SulphateNot more than 0,25 %IronNot more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy 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 DefinitionChemical namePropionic acidPropanoic acidEinecs201-176-3Chemical formulaC3H6O2Molecular weight74,08AssayContent not less than 99,5 %DescriptionColourless or slightly yellowish, oily liquid with a slightly pungent odour

Indentification A. Melting point

22 oC B. Distillation range 138,5 oC to 142,5 oCPurityNon-volatile residueNot more than 0,01 % when dried at 140 oC to constant weightAldehydesNot more than 0,1 % expressed as formaldehydeArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 281 SODIUM PROPIONATE DefinitionChemical nameSodium propionateSodium propanoateEinecs205-290-4Chemical formulaC3H5O2NaMolecular weight96,06AssayContent not less than 99 % after drying for two hours at 105 oCDescriptionWhite crystalline hygroscopic powder, or a fine white powderIdentification A. Positive tests for propionate and for sodium B. pH of a 10 % aqueous solution Not less than 7,5 and not more than 10,5PurityLoss on dryingNot more than 4 % determined by drying for two hours at 105 oCWater insolublesNot more than 0,1 %IronNot more than 50 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 282 CALCIUM PROPIONATE DefinitionChemical nameCalcium propionateEinecs223-795-8Chemical formulaC6H10O4CaMolecular weight186,22AssayContent not less than 99 %, after drying for two hours at 105 oCDescriptionWhite crystalline powderIdentification A. Positive tests for propionate and for calcium B. pH of a 10 % aqueous solution Between 6,0 and 9,0 PurityLoss on dryingNot more than 4 %, determined by drying for two hours at 105 oCWater insolublesNot more than 0,3 %IronNot more than 50 mg/kgFluorideNot more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 283 POTASSIUM PROPIONATE DefinitionChemical namePotassium propionatePotassium propanoateEinecs206-323-5Chemical formulaC3H5KO2Molecular weight112,17AssayContent not less than 99 % after drying for two hours at 105 oCDescriptionWhite crystalline powderIdentification A. Positive tests for propionate and for potassium PurityLoss on dryingNot more than 4 %, determined by drying for two hours at 105 oCWater-insoluble substancesNot more than 0,3 %IronNot more than 30 mg/kgFluorideNot more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 284 BORIC ACID SynonymsBoracic acidOrthoboric acidBorofaxDefinitionEinecs233-139-2Chemical formulaH3BO3Molecular weight61,84AssayContent not less than 99,5 %DescriptionColourless, 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 oC B. Burns with a nice green flame C. pH of a 3,3 % aqueous solution Between 3,8 and 4,8PurityPeroxidesNo colour develops with added KI-solutionArsenicNot more than 1 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 285 SODIUM TETRABORATE (BORAX) SynonymsSodium borateDefinitionChemical nameSodium tetraborateSodium biborateSodium pyroborateAnhydrous tetraborateEinecs215-540-4Chemical formulaNa2B4O7Na2B4O7·10H2OMolecular weight201,27DescriptionPowder or glass-like plates becoming opaque on exposure to air; slowly soluble in waterIdentification

A. Melting range Between 171 oC and 175 oC with decompositionPurityPeroxidesNo colour develops with added KI-solutionArsenicNot more than 1 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 290 CARBON DIOXIDE SynonymsCarbonic acid gasDry ice (solid form)Carbonic anhydrideDefinitionChemical nameCarbon dioxideEinecs204-696-9Chemical formulaCO2Molecular weight44,01AssayContent not less than 99 % v/v on the gaseous basis DescriptionA colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised cylinders or bulk storage systems, or in compressed solid blocks of dry ice. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as bindersIdentification 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 acidPurityAcidity915 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 sulphide915 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 solutionCarbon monoxideNot more than 10 μl/lOil contentNot more than 0,1 mg/l E 296 MALIC ACID SynonymsDL-Malic acid, pomalous acidDefinitionChemical nameDL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acidEinecs230-022-8Chemical formulaC4H6O5Molecular weight134,09AssayContent not less than 99,0 %DescriptionWhite or nearly white crystalline powder or granulesIdentification A. Melting range between 127 oC and 132 oC B. Positive test for malate C. Solutions of this substance are optically inactive in all concentrations PuritySulphated ashNot more than 0,1 %Fumaric acidNot more than 1,0 %Maleic acidNot more than 0,05 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 297 FUMARIC ACID DefinitionChemical nameTrans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acidEinecs203-743-0Chemical formulaC4H4O4 Molecular weight116,07AssayContent not less than 99,0 % on the anhydrous basisDescriptionWhite crystalline powder or granulesIdentification A. Melting range 286 oC-302 oC (closed capillary, rapid heating) B. Positive tests for double bonds and for 1,2-dicarboxylic acid C. pH of a 0,05 % solution at 25 oC 3,0-3,2PurityLoss on dryingNot more than 0,5 % (120 oC, 4h)Sulphated ashNot more than 0,1 %Maleic acidNot more than 0,1 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 300 ASCORBIC ACID DefinitionChemical nameL-ascorbic acidAscorbic acid2,3-Didehydro-L-threo-hexono-1,4-lactone3-Keto-L-gulofuranolactoneEinecs200-066-2Chemical formulaC6H8O6Molecular weight176,13AssayAscorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6DescriptionWhite to pale yellow, odourless crystalline solidIdentification

A. Melting range Between 189 oC and 193 oC with decomposition B. Positive tests for ascorbic acid PurityLoss on dryingNot more than 0,4 % after drying in a vacuum desiccator over sulphuric acid for 24 hoursSulphated ashNot more than 0,1 %Specific rotation[α]D20 between +20,5o and +21,5o (10 % w/v aqueous solution)pH of a 2 % aqueous solutionBetween 2,4 and 2,8ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 301 SODIUM ASCORBATE DefinitionChemical nameSodium ascorbateSodium L-ascorbate2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate3-Keto-L-gulofurano-lactone sodium enolateEinecs205-126-1Chemical formulaC6H7O6NaMolecular weight198,11AssaySodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6NaDescriptionWhite or almost white, odourless crystalline solid which darkens on exposure to lightIdentification A. Positive tests for ascorbate and for sodium PurityLoss on dryingNot more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hoursSpecific rotation[α]D20 between + 103o and + 106o (10 % w/v aqueous solution)pH of 10 % aqueous solutionBetween 6,5 and 8,0ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 302 CALCIUM ASCORBATE DefinitionChemical nameCalcium ascorbate dihydrateCalcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrateEinecs227-261-5Chemical formulaC12H14O12Ca· 2H2OMolecular weight426,35AssayContent not less than 98 % on a volatile matter-free basisDescriptionWhite to slightly pale greyish-yellow odourless crystalline powderIdentification A. Positive tests for ascorbate and for calcium PurityFluorideNot more than 10 mg/kg (expressed as fluorine)Specific rotation[α]D20 between + 95o and + 97o (5 % w/v aqueous solution)pH of 10 % aqueous solutionBetween 6,0 and 7,5Volatile matterNot more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxideArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 304 (i) ASCORBYL PALMITATE DefinitionChemical nameAscorbyl palmitateL-ascorbyl palmitate2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate6-palmitoyl-3-keto-L-gulofuranolactoneEinecs205-305-4Chemical formulaC22H38O7Molecular weight414,55AssayContent not less than 98 % on the dried basisDescriptionWhite or yellowish-white solid with a citrus-like odourIdentification A. Melting range Between 107 oC and 117 oCPurityLoss on dryingNot more than 2,0 % after drying in a vacuum oven at 56 oC and 60 oC for one hourSulphated ashNot more than 0,1 %Specific rotation[α]D20 between + 21o and + 24o (5 % w/v in methanol solution)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 304 (ii) ASCORBYL STEARATE

DefinitionChemical nameAscorbyl stearateL-ascorbyl stearate2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate6-stearoyl-3-keto-L-gulofuranolactoneEinecs246-944-9Chemical formulaC24H42O7Molecular weight442,6AssayContent not less than 98 %DescriptionWhite or yellowish, white solid with a citrus-like odourIdentification A. Melting point About 116 oCPurityLoss on dryingNot more than 2,0 % after drying in a vacuum oven at 56 oC to 60 oC for one hourSulphated ashNot more than 0,1 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 306 TOCOPHEROL-RICH EXTRACT DefinitionProduct obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienolsContains tocopherols such as d-α-, d-β-, d-γ- and d-ς-tocopherolsMolecular weight430,71 (d-α-tocopherol)AssayContent not less than 34 % of total tocopherolsDescriptionBrownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline formIdentification A. By suitable gas liquid chromatographic method B. Solubility tests Insoluble in water. Soluble in ethanol. Miscible in etherPuritySulphated ashNot more than 0,1 %Specific rotation[α]D20 not less than + 20oArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 307 ALPHA-TOCOPHEROL SynonymsDL-α-TocopherolDefinitionChemical nameDL-5,7,8-TrimethyltocolDL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanolEinecs233-466-0Chemical formulaC29H50O2Molecular weight430,71AssayContent not less than 96 %DescriptionSlightly yellow to amber, nearly odourless, clear, viscous oil which oxidises and darkens on exposure to air or lightIdentification A. Solubility tests Insoluble in water, freely soluble in ethanol, miscible in ether B. Spectro-photometry In absolute ethanol the maximum absorption is about 292 nmPurityRefractive indexn D201,503-1,507Specific absorption E 1%1cm in ethanol E 1%1cm(292 nm) 72-76 (0,01 g in 200 ml of absolute ethanol) Sulphated ashNot more than 0,1 %Specific rotation[α]D25 0o±0,05o (1 in 10 solution in chloroform)LeadNot more than 2 mg/kg E 308 GAMMA-TOCOPHEROL Synonymsdl-γ-TocopherolDefinitionChemical name2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanolEinecs231-523-4Chemical formulaC28H48O2Molecular weight416,69AssayContent not less than 97 %DescriptionClear, viscous, pale yellow oil which oxidises and darkens on exposure to air or lightIdentification A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nmPuritySpecific absorption E 1%1cm in ethanolE 1%1cm(298 nm) between 91 and 97E 1%1cm(257 nm) between 5,0 and 8,0Refractive index[n]D201,503-1,507Sulphated ashNot more than 0,1 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 309 DELTA-TOCOPHEROL

DefinitionChemical name2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanolEinecs204-299-0Chemical formulaC27H46O2Molecular weight402,7AssayContent not less than 97 %DescriptionClear, viscous, pale yellowish or orange oil which oxidises and darkens on exposure to air or lightIdentification A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nmPuritySpecific absorption E 1%1cm in ethanolE 1%1cm(298 nm) between 89 and 95E 1%1cm(257 nm) between 3,0 and 6,0Refractive indexn 20D1,500-1,504Sulphated ashNot more than 0,1 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 310 PROPYL GALLATE DefinitionChemical namePropyl gallatePropyl ester of gallic acidn-propyl ester of 3,4,5-trihydroxybenzoic acidEinecs204-498-2Chemical formulaC10H12O5Molecular weight212,20AssayContent not less than 98 % on the anhydrous basisDescriptionWhite to creamy-white, crystalline, odourless solidIdentification A. Solubility tests Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol B. Melting range Between 146 oC and 150 oC after drying at 110 oC for four hoursPurityLoss on dryingNot more than 1,0 % (110 oC, four hours)Sulphated ashNot more than 0,1 %Free acidNot more than 0,5 % (as gallic acid)Chlorinated organic compoundNot more than 100 mg/kg (as C1)Specific absorption E 1%1cm in ethanolE 1%1cm(275 nm) not less than 485 and not more than 520ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 311 OCTYL GALLATE DefinitionChemical nameOctyl gallateOctyl ester of gallic acidn-octyl ester of 3,4,5-trihydroxybenzoic acidEinecs213-853-0Chemical formulaC15H22O5Molecular weight282,34AssayContent not less than 98 % after drying at 90 oC for six hoursDescriptionWhite to creamy-white odourless solidIdentification A. Solubility tests Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol B. Melting range Between 99 oC and 102 oC after drying at 90 oC for six hoursPurityLoss on dryingNot more than 0,5 % (90 oC, six hours)Sulphated ashNot more than 0,05 %Free acidNot more than 0,5 % (as gallic acid)Chlorinated organic compoundNot more than 100 mg/kg (as C1)Specific absorption E 1%1cm in ethanolE 1%1cm(275 nm) not less than 375 and not more than 390 ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 312 DODECYL GALLATE SynonymsLauryl gallateDefinitionChemical nameDodecyl gallaten-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acidDodecyl ester of gallic acidEinecs214-620-6Chemical formulaC19H30O5Molecular weight338,45AssayContent not less than 98 % after drying at 90 oC for six hoursDescriptionWhite or creamy-white odourless solidIdentification A. Solubility tests Insoluble in water, freely soluble in ethanol and ether B. Melting range Between 95 oC and 98 oC after drying at 90 oC for six hoursPurityLoss on dryingNot more than 0,5 % (90 oC, six hours)Sulphated ashNot more than 0,05 %Free acidNot more than 0,5 % (as gallic acid)Chlorinated organic compoundNot more than 100 mg/kg (as Cl)Specific absorption E 1%1cm in ethanolE 1%1cm(275 nm) not less than 300 and not more than 325ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 30 mg/kg

E 315 ERYTHORBIC ACID SynonymsIsoascorbic acidD-Araboascorbic acidDefinitionChemical nameD-Erythro-hex-2-enoic acid γ-lactoneIsoascorbic acidD-Isoascorbic acidEinecs201-928-0Chemical formulaC6H8O6Molecular weight176,13AssayContent not less than 98 % on the anhydrous basisDescriptionWhite to slightly yellow crystalline solid which darkens gradually on exposure to light Identification A. Melting range About 164 oC to 172 oC with decomposition B. Positive test for ascorbic acid/colour reaction PurityLoss on dryingNot more than 0,4 % after drying under reduced pressure on silica gel for 3 hoursSulphated ashNot more than 0,3 %Specific rotation[α]10 % (w/v) aqueous solution between -16,5o to -18,0oOxalateTo 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 clearLeadNot more than 2 mg/kg E 316 SODIUM ERYTHORBATE SynonymsSodium isoascorbateDefinitionChemical nameSodium isoascorbateSodium D-isoascorbic acidSodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone3-keto-D-gulofurano-lactone sodium enolate monohydrateEinecs228-973-9Chemical formulaC6H7O6Na· H2OMolecular weight216,13AssayContent not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basisDescriptionWhite crystalline solidIdentification 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 PurityLoss on dryingNot more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hoursSpecific rotation[α]10 % (w/v) aqueous solution between + 95o and + 98opH of a 10 % aqueous solution5,5 to 8,0OxalateTo 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 clearArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ) SynonymsTBHQDefinitionChemical namesTert-butyl-1,4-benzenediol2-(1,1-Dimethylethyl)-1,4-benzenediolEinecs217-752-2Chemical formulaC10H14O2Molecular weight166,22AssayContent not less than 99 % of C10H14O2DescriptionWhite crystalline solid having a characteristic odourIdentification A. Solubility Practically insoluble in water; soluble in ethanol B. Melting point Not less than 126,5 oC 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 producedPurityTertiary-Butyl-p-benzoquinoneNot more than 0,2 %2,5-Di-tertiary-butyl hydroquinoneNot more than 0,2 %HydroxyquinoneNot more than 0,1 %TolueneNot more than 25 mg/kgLeadNot more than 2 mg/kg E 320 BUTYLATED HYDROXYANISOLE (BHA) SynonymsBHADefinitionChemical names3-Tertiary-butyl-4-hydroxyanisoleA mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisoleEinecs246-563-8Chemical formulaC11H16O2Formula weight180,25AssayContent not less than 98,5 % of C11H16O2 and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomerDescriptionWhite or slightly yellow crystals or waxy solid with a slight aromatic smellIdentification

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 groupsPuritySulphated ashNot more than 0,05 % after calcination at 800 ± 25 °CPhenolic impuritiesNot more than 0,5 %Specific absorptionE 1%1cmE 1%1cm (290 nm) not less than 190 and not more than 210Specific absorptionE 1%1cmE 1%1cm (228 nm) not less than 326 and not more than 345ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 321 BUTYLATED HYDROXYTOLUENE (BHT) SynonymsBHTDefinitionChemical name2,6-Ditertiary-butyl-p-cresol4-Methyl-2,6-ditertiarybutylphenolEinecs204-881-4Chemical formulaC15H24OMolecular weight220,36AssayContent not less than 99 %DescriptionWhite, crystalline or flaked solid, odourless or having a characteristic faint aromatic odourIdentification A. Solubility tests Insoluble in water and propane- 1,2-diolFreely soluble in ethanol B. Melting point At 70 oC C. Absorbance maximum The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100000 solution in dehydrated ethanol exhibits a maximum only at 278 nmPuritySulphated ashNot more than 0,005 %Phenolic impuritiesNot more than 0,5 %Specific absorption E1%1cm in ethanolE 1%1cm (278 nm) not less than 81 and not more than 88ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 322 LECITHINS SynonymsPhosphatidesPhospholipidsDefinitionLecithins 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 phosphatidesEinecs232-307-2Assay 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 oC-35 oC). 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 PurityLoss on dryingNot more than 2,0 % determined by drying at 105 oC for one hourToluene-insoluble matterNot 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 valueEqual to or less than 10ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 325 SODIUM LACTATE

DefinitionChemical nameSodium lactateSodium 2-hydroxypropanoateEinecs200-772-0Chemical formulaC3H5NaO3Molecular weight112,06 (anhydrous)AssayContent not less than 57 % and not more than 66 %DescriptionColourless, transparent, liquid. Odourless, or with a slight, characteristic odourIdentification A. Positive test for lactate B. Positive test for sodium PurityAcidityNot more than 0,5 % after drying expressed as lactic acidpH of a 20 % aqueous solution6,5 to 7,5ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgReducing substancesNo reduction of Fehling's solution Note: This specification refers to a 60 % aqueous solution E 326 POTASSIUM LACTATE DefinitionCheminal namePotassium lactatePotassium 2-hydroxypropanoateEinecs213-631-3Chemical formulaC3H5O3KMolecular weight128,17 (anhydrous)AssayContent not less than 57 % and not more than 66 % DescriptionSlightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odourIdentification 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 PurityArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgAcidityDissolve 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 requiredReducing substancesPotassium lactate solution shall not cause any reduction of Fehling's solution Note: This specification refers to a 60 % aqueous solution E 327 CALCIUM LACTATE DefinitionChemical nameCalcium dilactateCalcium dilactate hydrate2-Hydroxypropanoic acid calcium saltEinecs212-406-7Chemical formula(C3H5O2)2 Ca· nH2O (n = 0-5)Molecular weight218,22 (anhydrous)AssayContent not less than 98 % on the anhydrous basisDescriptionAlmost odourless, white crystalline powder or granulesIdentification A. Positive tests for lactate and for calcium B. Solubility tests Soluble in water and practically insoluble in ethanolPurityLoss on dryingDetermined by drying at 120 oC 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 % AcidityNot more than 0,5 % of the dry matter expressed as lactic acidFluorideNot more than 30 mg/kg (expressed as fluorine)pH of a 5 % solutionBetween 6,0 and 8,0ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kg MercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgReducing substancesNo reduction of Fehling's solution E 330 CITRIC ACID DefinitionChemical nameCitric acid2-Hydroxy-1,2,3-propanetricarboxylic acidβ-Hydroxytricarballytic acidEinecs201-069-1Chemical formula

(a) C6H8O7 (anhydrous) (b) C6H8O7·H2O (monohydrate) Molecular weight (a) 192,13 (anhydrous) (b) 210,15 (monohydrate) AssayCitric 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 basisDescriptionCitric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry airIdentification A. Solubility tests Very soluble in water; freely soluble in ethanol; soluble in etherPurityWater contentAnhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method)Sulphated ashNot more than 0,05 % after calcination at 800 ± 25 oCArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 5 mg/kgOxalatesNot more than 100 mg/kg, expressed as oxalic acid, after dryingReadily carbonisable substancesHeat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 oC 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 DefinitionChemical nameMonosodium citrateMonosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidChemical formula (a) C6H7O7Na (anhydrous) (b) C6H7O7Na· H2O (monohydrate) Molecular weight (a) 214,11 (anhydrous) (b) 232,23 (monohydrate) AssayContent not less than 99 % on the anhydrous basisDescriptionCrystalline white powder or colourless crystals Identification A. Positive tests for citrate and for sodium PurityLoss on drying Determined by drying at 180 oC for four hours: anhydrous: not more than 1,0 % monohydrate: not more than 8,8 % OxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingpH of a 1 % aqueous solutionBetween 3,5 and 3,8ArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 5 mg/kg E 331 (ii) DISODIUM CITRATE Synonyms Disodium citrate Dibasic sodium citrate DefinitionChemical nameDisodium citrateDisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidDisodium salt of citric acid with 1,5 molecules of waterEinecs205-623-3Chemical formulaC6H6O7Na2·1,5H2OMolecular weight263,11AssayContent not less than 99 % on the anhydrous basisDescriptionCrystalline white powder or colourless crystalsIdentification A. Positive tests for citrate and for sodium PurityLoss on dryingNot more than 13,0 % by drying at 180 oC for four hoursOxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingpH of a 1 % aqueous solutionBetween 4,9 and 5,2ArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 5 mg/kg E 331 (iii) TRISODIUM CITRATE Synonyms Trisodium citrate Tribasic sodium citrate DefinitionChemical nameTrisodium citrateTrisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidTrisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form

Einecs200-675-3Chemical formulaAnhydrous:C6H5O7Na3Hydrated:C6H5O7Na3·nH2O (n = 2 or 5)Molecular weight258,07 (anhydrous)AssayNot less than 99 % on the anhydrous basisDescriptionCrystalline white powder or colourless crystalsIdentification A. Positive tests for citrate and for sodium PurityLoss on dryingDetermined by drying at 180 oC for four hours: anhydrous: not more than 1,0 % dihydrate: not more than 13,5 % pentahydrate: not more than 30,3 %OxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingpH of a 5 % aqueous solutionBetween 7,5 and 9,0ArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 5 mg/kg E 332 (i) MONOPOTASSIUM CITRATE Synonyms Monopotassium citrate Monobasic potassium citrate DefinitionChemical nameMonopotassium citrateMonopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidAnhydrous monopotassium salt of citric acidEinecs212-753-4Chemical formulaC6H7O7KMolecular weight230,21AssayContent not less than 99 % on the anhydrous basisDescriptionWhite, hygroscopic, granular powder or transparent crystalsIdentification A. Positive tests for citrate and for potassium PurityLoss on dryingNot more than 1,0 % determined by drying at 180 oC for four hoursOxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingpH of a 1 % aqueous solutionBetween 3,5 and 3,8ArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 5 mg/kg E 332 (ii) TRIPOTASSIUM CITRATE Synonyms Tripotassium citrate Tribasic potassium citrate DefinitionChemical nameTripotassium citrateTripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidMonohydrated tripotassium salt of citric acidEinecs212-755-5Chemical formulaC6H5O7K3·H2OMolecular weight324,42AssayContent not less than 99 % on the anhydrous basisDescriptionWhite, hygroscopic, granular powder or transparent crystalsIdentification A. Positive tests for citrate and for potassium PurityLoss on dryingNot more than 6,0 % determined by drying at 180 oC for four hoursOxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingpH of a 5 % aqueous solutionBetween 7,5 and 9,0ArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 5 mg/kg E 333 (i) MONOCALCIUM CITRATE Synonyms Monocalcium citrate Monobasic calcium citrate DefinitionChemical nameMonocalcium citrateMonocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidMonohydrate monocalcium salt of citric acidChemical formula(C6H7O7)2Ca· H2OMolecular weight440,32AssayContent not less than 97,5 % on the anhydrous basisDescriptionFine white powderIdentification A. Positive tests for citrate and for calcium PurityLoss on dryingNot more than 7,0 % determined by drying at 180 oC for four hoursOxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingpH of a 1 % aqueous solutionBetween 3,2 and 3,5FluorideNot more than 30 mg/kg (expressed as fluorine)ArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 5 mg/kgCarbonatesDissolving 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 DefinitionChemical nameDicalcium citrateDicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidTrihydrated dicalcium salt of citric acidChemical formula(C6H7O7)2Ca2·3H2OMolecular weight530,42AssayNot less than 97,5 % on the anhydrous basisDescriptionFine white powderIdentification A. Positive tests for citrate and for calcium PurityLoss on dryingNot more than 20,0 % determined by drying at 180 oC for four hoursOxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingFluorideNot more than 30 mg/kg (expressed as fluorine)ArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 5 mg/kgCarbonatesDissolving 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 DefinitionChemical nameTricalcium citrateTricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidTetrahydrated tricalcium salt of citric acidEinecs212-391-7Chemical formula(C6H6O7)2Ca3·4H2OMolecular weight570,51AssayNot less than 97,5 % on the anhydrous basisDescriptionFine white powderIdentification A. Positive tests for citrate and for calcium PurityLoss on dryingNot more than 14,0 % determined by drying at 180 oC for four hoursOxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingFluorideNot more than 30 mg/kg (expressed as fluorine)ArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 5 mg/kgCarbonatesDissolving 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 DefinitionChemical nameL-tartaric acidL-2,3-dihydroxybutanedioic acidd-α, β-dihydroxysuccinic acidEinecs201-766-0Chemical formulaC4H6O6Molecular weight150,09AssayContent not less than 99,5 % on the anhydrous basisDescriptionColourless or translucent crystalline solid or white crystalline powderIdentification A. Melting range Between 168 oC and 170 oC B. Positive test for tartrate PurityLoss on dryingNot more than 0,5 % (over P2O5, three hours)Sulphated ashNot more than 1000 mg/kg after calcination at 800 ± 25 oCSpecific optical rotation of a 20 % w/v aqueous solution[α] 20D between +11,5o and +13,5oLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgOxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying E 335 (i) MONOSODIUM TARTRATE SynonymsMonosodium salt of L-(+)-tartaric acidDefinitionChemical nameMonosodium salt of L-2,3-dihydroxybutanedioic acidMonohydrated monosodium salt of L-(+)-tartaric acidChemical formulaC4H5O6Na· H2OMolecular weight194,05AssayContent not less than 99 % on the anhydrous basisDescriptionTransparent colourless crystalsIdentification A. Positive tests for tartrate and for sodium PurityLoss on dryingNot more than 10,0 % determined by drying at 105 oC for four hoursOxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg

E 335 (ii) DISODIUM TARTRATE DefinitionChemical nameDisodium L-tartrateDisodium (+)-tartrateDisodium (+)-2,3-dihydroxybutanedioic acidDihydrated disodium salt of L-(+)-tartaric acidEinecs212-773-3Chemical formulaC4H4O6Na2·2H2OMolecular weight230,8AssayContent not less than 99 % on the anhydrous basisDescriptionTransparent, colourless crystalsIdentification A. Positive tests for tartrate and for sodium B. Solubility tests 1 gram is insoluble in 3 ml of water. Insoluble in ethanolPurityLoss on dryingNot more than 17,0 % determined by drying at 150 oC for four hoursOxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingpH of a 1 % aqueous solutionBetween 7,0 and 7,5ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 336 (i) MONOPOTASSIUM TARTRATE SynonymsMonobasic potassium tartrateDefinitionChemical nameAnhydrous monopotassium salt of L-(+)-tartaric acidMonopotassium salt of L-2,3-dihydroxybutanedioic acidChemical formulaC4H5O6KMolecular weight188,16AssayContent not less than 98 % on the anhydrous basisDescriptionWhite crystalline or granulated powderIdentification A. Positive tests for tartrate and for potassium B. Melting point 230 oCPuritypH of a 1 % aqueous solution3,4Loss on dryingNot more than 1,0 % determined by drying at 105 oC for four hoursOxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 336 (ii) DIPOTASSIUM TARTRATE SynonymsDibasic potassium tartrateDefinitionChemical nameDipotassium salt of L-2,3-dihydroxybutanedioic acidDipotassium salt with half a molecule of water of L-(+)-tartaric acidEinecs213-067-8Chemical formulaC4H4O6K2·1/2H2OMolecular weight235,2AssayContent not less than 99 % on the anhydrous basisDescriptionWhite crystalline or granulated powderIdentification A. Positive tests for tartrate and for potassium PuritypH of a 1 % aqueous solutionBetween 7,0 and 9,0Loss on dryingNot more than 4,0 % determined by drying at 150 oC for four hoursOxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 337 POTASSIUM SODIUM TARTRATE SynonymsPotassium sodium L-(+)-tartrateRochelle saltSeignette saltDefinitionChemical namePotassium sodium salt of L-2,3-dihydroxybutanedioic acidPotassium sodium L-(+)-tartrateEinecs206-156-8Chemical formulaC4H4O6KNa· 4H2OMolecular weight282,23AssayContent not less than 99 % on the anhydrous basisDescriptionColourless crystals or white crystalline powderIdentification 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 oCPurityLoss on dryingNot more than 26,0 % and not less than 21,0 % determined by drying at 150 oC for three hoursOxalatesNot more than 100 mg/kg expressed as oxalic acid, after dryingpH of 1 % aqueous solutionBetween 6,5 and 8,5ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kg

MercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 338 PHOSPHORIC ACID SynonymsOrthophosphoric acidMonophosphoric acidDefinitionChemical namePhosphoric acidEinecs231-633-2Chemical formulaH3PO4Molecular weight98,00AssayPhosphoric acid is commercially available as an aqueous solution at variable concentrations. Content not less than 67,0 % and not more than 85,7 %.DescriptionClear, colourless, viscous liquidIdentification A. Positive tests for acid and for phosphate PurityVolatile acidsNot more than 10 mg/kg (as acetic acid)ChloridesNot more than 200 mg/kg (expressed as chlorine)NitratesNot more than 5 mg/kg (as NaNO3)SulphatesNot more than 1500 mg/kg (as CaSO4)FluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg Note: This specification refers to a 75 % aqueous solution E 339 (i) MONOSODIUM PHOSPHATE SynonymsMonosodium monophosphateAcid monosodium monophosphateMonosodium orthophosphateMonobasic sodium phosphateSodium dihydrogen monophosphateDefinitionChemical nameSodium dihydrogen monophosphateEinecs231-449-2Chemical formulaAnhydrous: NaH2PO4Monohydrate: NaH2PO4 · H2ODihydrate: NaH2PO4 · 2H2O Molecular weightAnhydrous: 119,98Monohydrate: 138,00Dihydrate: 156,01AssayAfter drying at 60 oC for one hour and then at 105 oC for four hours, contains not less than 97 % of NaH2PO4P2O5 contentBetween 58,0 % and 60,0 % on the anhydrous basisDescriptionA white odourless, slightly deliquescent powder, crystals or granulesIdentification 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 5,0PurityLoss on dryingThe 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 oC for one hour, then at 105 oC for four hoursWater-insoluble substancesNot more than 0,2 % on the anhydrous basisFluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 339 (ii) DISODIUM PHOSPHATE SynonymsDisodium monophosphateSecondary sodium phosphateDisodium orthophosphateAcid disodium phosphateDefinitionChemical nameDisodium hydrogen monophosphateDisodium hydrogen orthophosphateEinecs231-448-7Chemical formulaAnhydrous: Na2HPO4Hydrat: Na2HPO4 · nH2O (n = 2,7 or 12)Molecular weight141,98 (anhydrous)AssayAfter drying at 40 oC for three hours and subsequently at 105 oC for five hours, contains not less than 98 % of Na2HPO4P2O5 contentBetween 49 % and 51 % on the anhydrous basisDescriptionAnhydrous 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 crystalsIdentification

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 PurityLoss on dryingWhen dried at 40 oC for three hours and then at 105 oC 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 substancesNot more than 0,2 % on the anhydrous basisFluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 339 (iii) TRISODIUM PHOSPHATE SynonymsSodium phosphateTribasic sodium phosphateTrisodium orthophosphateDefinitionTrisodium 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 1/4 molecule of NaOHChemical nameTrisodium monophosphateTrisodium phosphateTrisodium orthophosphateEinecs231-509-8Chemical formulaAnhydrous: Na3PO4Hydrated: Na3PO4 · nH2O (n = 1/2, 1, 6, 8, or 12)Molecular weight163,94 (anhydrous)AssaySodium 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 basisP2O5 contentBetween 40,5 % and 43,5 % on the anhydrous basisDescriptionWhite odourless crystals, granules or crystalline powderIdentification 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 12,5PurityLoss on ignitionWhen dried at 120 oC for two hours and then ignited at about 800 oC 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 substancesNot more than 0,2 % on the anhydrous basisFluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 340 (i) MONOPOTASSIUM PHOSPHATE SynonymsMonobasic potassium phosphateMonopotassium monophosphatePotassium orthophosphateDefinitionChemical namePotassium dihydrogen phosphateMonopotassium dihydrogen orthophosphateMonopotassium dihydrogen monophosphateEinecs231-913-4Chemical formulaKH2PO4Molecular weight136,09AssayContent not less than 98,0 % after drying at 105 oC for four hoursP2O5 contentBetween 51,0 % and 53,0 % on the anhydrous basisDescriptionOdourless, colourless crystals or white granular or crystalline powder, hygroscopicIdentification 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 4,8PurityLoss on dryingNot more than 2,0 % determined by drying at 105 oC for four hoursWater-insoluble substancesNot more than 0,2 % on the anhydrous basisFluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg

E 340 (ii) DIPOTASSIUM PHOSPHATE SynonymsDipotassium monophosphateSecondary potassium phosphateDipotassium acid phosphateDipotassium orthophosphateDibasic potassium phosphateDefinitionChemical nameDipotassium hydrogen monophosphateDipotassium hydrogen phosphateDipotassium hydrogen orthophosphateEinecs231-834-5Chemical formulaK2HPO4Molecular weight174,18AssayContent not less than 98 % after drying at 105 oC for four hoursP2O5 contentBetween 40,3 % and 41,5 % on the anhydrous basisDescriptionColourless 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 9,4PurityLoss on dryingNot more than 2,0 % determined by drying at 105 oC for four hoursWater-insoluble substancesNot more than 0,2 % on the anhydrous basisFluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 340 (iii) TRIPOTASSIUM PHOSPHATE SynonymsPotassium phosphateTribasic potassium phosphateTripotassium orthophosphateDefinitionChemical nameTripotassium monophosphateTripotassium phosphateTripotassium orthophosphateEinecs231-907-1Chemical formulaAnhydrous: K3PO4Hydrated: K3PO4 · nH2O (n = 1 or 3)Molecular weight212,27 (anhydrous)AssayContent not less than 97 % calculated on the ignited basisP2O5 contentBetween 30,5 % and 33,0 % on the ignited basisDescriptionColourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrateIdentification 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 12,3PurityLoss on ignitionAnhydrous: not more than 3,0 %; hydrated: not more than 23,0 %. Determined by drying at 105 oC for one hour and then ignite at about 800 oC ± 25 oC for 30 minutesWater insoluble substancesNot more than 0,2 % on the anhydrous basisFluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 341 (i) MONOCALCIUM PHOSPHATE SynonymsMonobasic calcium phosphateMonocalcium orthophosphateDefinitionChemical nameCalcium dihydrogen phosphateEinecs231-837-1Chemical formulaAnhydrous: Ca(H2PO4)2Monohydrate: Ca(H2PO4)2 · H2OMolecular weight234,05 (anhydrous)252,08 (monohydrate)AssayContent not less than 95 % on the dried basisP2O5 contentBetween 55,5 % and 61,1 % on the anhydrous basisDescriptionGranular powder or white, deliquescent crystals or granulesIdentification 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)PurityLoss on dryingNot more than 14 % determined by drying at 105 oC for four hours (anhydrous)Not more than 17,5 % determined by drying at 60 oC for one hour, then at 105 oC for four hours (monohydrate)Loss on ignitionNot more than 17,5 % after ignition at 800 oC ± 25 oC for 30 minutes (anhydrous)Not more than 25,0 % determined by drying at 105 oC for one hour, then ignite at 800 oC ± 25 oC for 30 minutes (monohydrate)FluorideNot more than 30 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg

E 341 (ii) DICALCIUM PHOSPHATE SynonymsDibasic calcium phosphateDicalcium orthophosphateDefinitionChemical nameCalcium monohydrogen phosphateCalcium hydrogen orthophosphateSecondary calcium phosphateEinecs231-826-1Chemical formulaAnhydrous: CaHPO4Dihydrate: CaHPO4 · 2H2OMolecular weight136,06 (anhydrous)172,09 (dihydrate)AssayDicalcium phosphate, after drying at 200 oC for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4P2O5 contentBetween 50,0 % and 52,5 % on the anhydrous basisDescriptionWhite 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 ethanolPurityLoss on ignitionNot more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 oC ± 25 oC for 30 minutesFluorideNot more than 50 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 341 (iii) TRICALCIUM PHOSPHATE SynonymsCalcium phosphate, tribasicCalcium orthophosphatePentacalcium hydroxy monophosphateCalcium hydroxyapatiteDefinitionTricalcium 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 · H2OChemical namePentacalcium hydroxy monophosphateTricalcium monophosphateEinecs235-330-6 (Pentacalcium hydroxy monophosphate)231-840-8 (Calcium orthophosphate)Chemical formulaCa5(PO4)3· OH or Ca3(PO4)2Molecular weight502 or 310AssayContent not less than 90 % calculated on the ignited basisP2O5 contentBetween 38,5 % and 48,0 % on the anhydrous basisDescriptionA white, odourless powder which is stable in airIdentification A. Positive tests for calcium and for phosphate B. Solubility Practically insoluble in water; insoluble in ethanol soluble in dilute hydrochloric and nitric acidPurityLoss on ignitionNot more than 8 % after ignition at 800 oC ± 25 oC, to constant weightFluorideNot more than 50 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 343(i) MONOMAGNESIUM PHOSPHATE SynonymsMagnesiumdihydrogenphosphateMagnesiumphosphate, monobasicMonomagnesium orthophosphateDefinitionChemical nameMonomagnesiumdihydrogenmonophosphateEinecs236-004-6Chemical formulaMg(H2PO4)2 · nH2O (where n = 0 to 4)Molecular weight218,30 (anhydrous)AssayNot less than 51,0 % after ignitionDescriptionWhite, odourless, crystalline powder, slightly soluble in waterIdentification A. Positive test for magnesium and for phosphate B. MgO content Not less than 21,5 % after ignitionPurityFluorideNot more than 10 mg/kg (as fluorine)ArsenicNot more than 3 mg/kgLeadNot more than 4 mg/kgCadmiumNot more than 1 mg/kgMercuryNot more than 1 mg/kg E 343(ii) DIMAGNESIUM PHOSPHATE SynonymsMagnesiumhydrogenphosphateMagnesiumphosphate, dibasicDimagnesium orthophosphateSecondary magnesiumphosphateDefinitionChemical nameDimagnesiummonohydrogenmonophosphateEinecs231-823-5Chemical formulaMgHPO4 · nH2O (where n = 0-3)Molecular weight120,30 (anhydrous)AssayNot less than 96 % after ignitionDescriptionWhite, odourless, crystalline powder, slightly soluble in waterIdentification

A. Positive test for magnesium and for phosphate B. MgO content: Not less than 33,0 % calculated on an anhydrous basisPurityFluorideNot more than 10 mg/kg (as fluorine)ArsenicNot more than 3 mg/kgLeadNot more than 4 mg/kgCadmiumNot more than 1 mg/kgMercuryNot more than 1 mg/kg E 350 (i) SODIUM MALATE SynonymsSodium salt of malic acidDefinitionChemical nameDisodium DL-malate, disodium salt of hydroxybutanedioic acidChemical formulaHemihydrate: C4H4Na2O5 · 1/2 H2OTrihydrate: C4H4Na2O5 · 3H2OMolecular weightHemihydrate: 187,05Trihydrate: 232,10AssayContent not less than 98,0 % on the anhydrous basisDescriptionWhite crystalline powder or lumpsIdentification A. Positive tests for 1,2-dicarboxylic acid and for sodium B. Azo dye formation Positive C. Solubility Freely soluble in waterPurityLoss on dryingNot more than 7,0 % (130 oC, 4h) for the hemihydrate, or 20,5 %-23,5 % (130 oC, 4h) for the trihydrateAlkalinityNot more than 0,2 % as Na2CO3Fumaric acidNot more than 1,0 %Maleic acidNot more than 0,05 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 350 (ii) SODIUM HYDROGEN MALATE SynonymsMonosodium salt of DL-malic acidDefinitionChemical nameMonosodium DL-malate, monosodium 2-DL-hydroxy succinateChemical formulaC4H5NaO5Molecular weight156,07AssayContent not less than 99,0 % on the anhydrous basisDescriptionWhite powderIdentification A. Positive tests for 1,2-dicarboxylic acid and for sodium B. Azo dye formation PositivePurityLoss on dryingNot more than 2,0 % (110 oC, 3h)Maleic acidNot more than 0,05 %Fumaric acidNot more than 1,0 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 351 POTASSIUM MALATE SynonymsPotassium salt of malic acidDefinitionChemical nameDipotassium DL-malate, dipotassium salt of hydroxybutanedioic acidChemical formulaC4H4K2O5Molecular weight210,27AssayContent not less than 59,5 %DescriptionColourless or almost colourless aqueous solutionIdentification A. Positive tests for 1,2-dicarboxylic acid and for potassium B. Azo dye formation PositivePurityAlkalinityNot more than 0,2 % as K2CO3Fumaric acidNot more than 1,0 %Maleic acidNot more than 0,05 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 352 (i) CALCIUM MALATE SynonymsCalcium salt of malic acidDefinitionChemical nameCalcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydroxybutanedioic acidChemical formulaC4H5CaO5Molecular weight172,14AssayContent not less than 97,5 % on the anhydrous basisDescriptionWhite powderIdentification A. Positive tests for malate, 1,2-dicarboxylic acid and for calcium B. Azo dye formation Positive C. Solubility Slightly soluble in waterPurityLoss on dryingNot more than 2 % (100 oC, 3h)AlkalinityNot more than 0,2 % as CaCO3Maleic acidNot more than 0,05 %Fumaric acidNot more than 1,0 %FluorideNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 352 (ii) CALCIUM HYDROGEN MALATE SynonymsMonocalcium salt of DL-malic acidDefinitionChemical nameMonocalcium DL-malate, monocalcium 2-DL-hydroxysuccinateChemical formula(C4H5O5)2CaAssayContent not less than 97,5 % on the anhydrous basisDescriptionWhite powderIdentification

A. Positive tests for 1,2-dicarboxylic acid and for calcium B. Azo dye formation PositivePurityLoss on dryingNot more than 2,0 % (110 oC, 3h)Maleic acidNot more than 0,05 %Fumaric acidNot more than 1,0 %FluorideNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 353 METATARTARIC ACID SynonymsDitartaric acidDefinitionChemical nameMetatartaric acidChemical formulaC4H6O6AssayNot less than 99,5 %DescriptionCrystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of caramelIdentificationA.Very soluble in water and ethanolB.Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulfuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 oC, an intense violet coloration appearsPurityArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 354 CALCIUM TARTRATE SynonymsL-Calcium tartrateDefinitionChemical nameCalcium L(+)-2,3-dihydroxybutanedioate di-hydrateChemical formulaC4H4CaO6 · 2H2OMolecular weight224,18AssayNot less than 98,0 % DescriptionFine crystalline powder with a white or off-white colourIdentification A. Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids B. Specific rotation [α]20D +7,0o to +7,4o (0,1 % in a 1N de HCl solution) C. pH of a 5 % slurry Between 6,0 and 9,0PuritySulphates (as H2SO4)Not more than 1 g/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 355 ADIPIC ACID DefinitionChemical nameHexanedioic acid, 1,4-butanedicarboxylic acidEinecs204-673-3Chemical formulaC6H10O4Molecular weight146,14AssayContent not less than 99,6 %DescriptionWhite odourless crystals or crystalline powderIdentification A. Melting range 151,5 oC-154,0 oC B. Solubility Slightly soluble in water. Freely soluble in ethanolPurityWaterNot more than 0,2 % (Karl Fischer method)Sulphated ashNot more than 20 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 356 SODIUM ADIPATE DefinitionChemical nameSodium adipateEinecs231-293-5Chemical formulaC6H8Na2O4Molecular weight190,11AssayContent not less than 99,0 % (on anhydrous basis)DescriptionWhite odourless crystals or crystalline powderIdentification A. Melting range 151 oC-152 oC (for adipic acid) B. Solubility Approximately 50 g/100 ml water (20 oC) C. Positive test for sodium PurityWaterNot more than 3 % (Karl Fischer)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 357 POTASSIUM ADIPATE DefinitionChemical namePotassium adipateEinecs242-838-1Chemical formulaC6H8K2O4Molecular weight222,32AssayContent not less than 99,0 % (on anhydrous basis)DescriptionWhite odourless crystals or crystalline powderIdentification A. Melting range 151 oC-152 oC (for adipic acid) B. Solubility Approximately 60 g/100 ml water (20 oC) C. Positive test for potassium

PurityWaterNot more than 3 % (Karl Fischer)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 363 SUCCINIC ACID DefinitionChemical nameButanedioic acidEinecs203-740-4Chemical formulaC4H6O4Molecular weight118,09AssayContent no less than 99,0 %DescriptionColourless or white, odourless crystalsIdentification A. Melting range Between 185,0 oC and 190,0 oCPurityResidue on ignitionNot more than 0,025 % (800 oC, 15 min)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 380 TRIAMMONIUM CITRATE SynonymsTribasic ammonium citrateDefinitionChemical nameTriammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acidEinecs222-394-5Chemical formulaC6H17N3O7Molecular weight243,22AssayContent not less than 97,0 %DescriptionWhite to off-white crystals or powderIdentification A. Positive tests for ammonium and for citrate B. Solubility Freely soluble in waterPurityOxalateNot more than 0,04 % (as oxalic acid)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE SynonymsCalcium disodium EDTACalcium disodium edetateDefinitionChemical nameN, N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]calciate(2)-disodiumCalcium disodium ethylenediaminetetra acetate Calcium disodium (ethylenedinitrilo)tetra acetateEinecs200-529-9Chemical formulaC10H12O8CaN2Na2·2H2OMolecular weight410,31AssayContent not less than 97 % on the anhydrous basisDescriptionWhite, odourless crystalline granules or white to nearly white powder, slightly hygroscopicIdentification 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 PurityWater content5 to 13 % (Karl Fischer method)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 400 ALGINIC ACID DefinitionLinear 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)Einecs232-680-1Chemical formula(C6H8O6)nMolecular weight10000-600000 (typical average)AssayAlginic 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)DescriptionAlginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourlessIdentification 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 purplePuritypH of a 3 % suspensionBetween 2,0 and 3,5Loss on dryingNot more than 15 % (105 oC, 4 hours)Sulphated ashNot more than 8 % on the anhydrous basisSodium hydroxide (1 M solution)Not more than 2 % on the anhydrous basis insoluble matterArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kgTotal plate countNot more than 5000 colonies per gramYeast and mouldsNot more than 500 colonies per gramE. coliNegative in 5 gSalmonella spp.Negative in 10 g E 401 SODIUM ALGINATE DefinitionChemical nameSodium salt of alginic acidChemical formula(C6H7NaO6)nMolecular weight10000-600000 (typical average)AssayYields, 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)DescriptionNearly odourless, white to yellowish fibrous or granular powderIdentification A. Positive test for sodium and alginic acid PurityLoss on dryingNot more than 15 % (105 oC, 4 hours)Water-insoluble matterNot more than 2 % on the anhydrous basisArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kgTotal plate countNot more than 5000 colonies per gramYeast and mouldsNot more than 500 colonies per gramE. coliNegative in 5 gSalmonella spp.Negative in 10 g E 402 POTASSIUM ALGINATE DefinitionChemical namePotassium salt of alginic acidChemical formula(C6H7KO6)nMolecular weight10000-600000 (typical average)AssayYields, 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)DescriptionNearly odourless, white to yellowish fibrous or granular powderIdentification A. Positive test for potassium and for alginic acid PurityLoss on dryingNot more than 15 % (105 oC, 4 hours)Water-insoluble matterNot more than 2 % on the anhydrous basisArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kgTotal plate countNot more than 5000 colonies per gram Yeast and mouldsNot more than 500 colonies per gramE. coliNegative in 5 gSalmonella spp.Negative in 10 g

E 403 AMMONIUM ALGINATE DefinitionChemical nameAmmonium salt of alginic acidChemical formula(C6H11NO6)nMolecular weight10000 — 600000 (typical average)AssayYields, 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)DescriptionWhite to yellowish fibrous or granular powderIdentification A. Positive test for ammonium and alginic acid PurityLoss on dryingNot more than 15 % (105 oC, 4 hours)Sulphated ashNot more than 7 % on the dried basisWater-insoluble matterNot more than 2 % on the anhydrous basisArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metalsNot more than 20 mg/kgTotal plate countNot more than 5000 colonies per gramYeast and mouldsNot more than 500 colonies per gramE. coliNegative in 5 gSalmonella spp.Negative in 10 g E 404 CALCIUM ALGINATE SynonymsCalcium salt of alginateDefinitionChemical nameCalcium salt of alginic acidChemical formula(C6H7Ca1/2O6)nMolecular weight10000-600000 (typical average)AssayYields, 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)DescriptionNearly odourless, white to yellowish fibrous or granular powderIdentification A. Positive test for calcium and alginic acid PurityLoss on dryingNot more than 15,0 % (105 oC, 4 hours)ArsenicNot more than 3 mg/kg LeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kgTotal plate countNot more than 5000 colonies per gramYeast and mouldsNot more than 500 colonies per gramE. coliNegative in 5 gSalmonella spp.Negative in 10 g E 405 PROPANE-1,2-DIOL ALGINATE SynonymsHydroxypropyl alginate1,2-propanediol ester of alginic acidPropylene glycol alginateDefinitionChemical namePropane-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 moleculeChemical formula(C9H14O7)n (esterified)Molecular weight10000-600000 (typical average)AssayYields, on the anhydrous basis, not less than 16 % and not more than 20 % of CO2 of carbon dioxideDescriptionNearly odourless, white to yellowish brown fibrous or granular powderIdentification A. Positive test for 1,2-propanediol and alginic acid after hydrolysis PurityLoss on dryingNot more than 20 % (105 oC, 4 hours)Total propane-1,2-diol contentNot less than 15 % and not more than 45 %Free propane-1,2-diol contentNot more than 15 %Water-insoluble matterNot more than 2 % on the anhydrous basisArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kgTotal plate countNot more than 5000 colonies per gramYeast and mouldsNot more than 500 colonies per gramE. coliNegative in 5 gSalmonella spp.Negative in 10 g

E 406 AGAR SynonymsGeloseJapan agarBengal, Ceylon, Chinese or Japanese isinglassLayor CarangDefinitionChemical nameAgar 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 and Sphaerococcaceae and related red algae of the class RhodophyceaeEinecs232-658-1AssayThe threshold gel concentration should not be higher than 0,25 %DescriptionAgar 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 sucroseIdentification A. Solubility Insoluble in cold water; soluble in boiling waterPurityLoss on dryingNot more than 22 % (105 oC, 5 hours)AshNot more than 6,5 % on the anhydrous basis determined at 550 oCAcid-insoluble ash (insoluble in approximately 3N Hydrochloric acid)Not more than 0,5 % determined at 550 oC on the anhydrous basisInsoluble matter (in hot water)Not more than 1,0 %StarchNot 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 producedGelatin and other proteinsDissolve about 1 g of agar in 100 ml of boiling water and allow to cool of about 50 oC. 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 minutesWater absorptionPlace 5 g to agar in a 100 ml graduated cylinder, fill to the mark with water, mix and allow to stand at about 25 oC 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 obtainedArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kg E 407 CARRAGEENAN SynonymsProducts of commerce are sold under different names such as:Irish moss geloseEucheuman (from Eucheuma spp.)Iridophycan (from Iridaea spp.)Hypnean (from Hypnea spp.)Furcellaran or Danish agar (from Furcellaria fastigiata)Carrageenan (from Chondrus and Gigartina spp.)DefinitionCarrageenan is obtained by aqueous extraction of natural strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae 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 degradedEinecs232-524-2DescriptionYellowish to colourless, coarse to fine powder which is practically odourlessIdentification

A. Positive tests for galactose, for anhydrogalactose and for sulphate PurityMethanol, ethanol propane-2-ol contentNot more than 0,1 % singly or in combinationViscosity of a 1,5 % solution at 75 oCNot less than 5 mPa.sLoss on dryingNot more than 12 % (105 oC, four hours)SulphateNot less than 15 % and not more than 40 % on the dried basis (as SO4)AshNot less than 15 % and not more than 40 % determined on the dried basis at 550 oCAcid-insoluble ashNot more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)Acid-insoluble matterNot 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 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgTotal plate countNot more than 5000 colonies per gramYeast and mouldsNot more than 300 colonies per gramE. coliNegative in 5 gSalmonella spp.Negative in 10 g E 407a PROCESSED EUCHEUMA SEAWEED SynonymsPES (acronym for processed eucheuma seaweed)DefinitionProcessed 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 consists chiefly of the potassium salts 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 degradedDescriptionTan to yellowish, coarse to fine powder which is practically odourlessIdentification A. Positive tests for galactose, for anhydrogalactose and for sulphate B. Solubility Forms cloudy viscous suspensions in water. Insoluble in ethanolPurityMethanol, ethanol, propane-2-ol contentNot more than 0,1 % singly or in combinationViscosity of a 1,5 % solution at 75 oCNot less than 5 mPa.sLoss on dryingNot more than 12 % (105 oC, four hours)SulphateNot less than 15 % and not more than 40 % on the dried basis (as SO4)AshNot less than 15 % and not more than 40 % determined on the dried basis at 550 oCAcid-insoluble ashNot more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)Acid-insoluble matterNot 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 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgTotal plate countNot more than 5000 colonies per gramYeast and mouldsNot more than 300 colonies per gramE. coliNegative in 5 gSalmonella spp.Negative in 10 g

E 410 LOCUST BEAN GUM SynonymsCarob bean gumAlgaroba gumDefinitionLocust 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 galactomannanMolecular weight50000-3000000 Einecs232-541-5AssayGalactomannan content not less than 75 %DescriptionWhite to yellowish-white, nearly odourless powderIdentification 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 ethanolPurityLoss on dryingNot more than 15 % (105 oC, 5 hours)AshNot more than 1,2 % determined at 800 oCProtein (N × 6,25)Not more than 7 %Acid-insoluble matterNot more than 4 %StarchNot 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 producedArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kgEthanol and propane-2-olNot more than 1 %, single or in combination E 412 GUAR GUM SynonymsGum cyamopsisGuar flourDefinitionGuar 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 galactomannanEinecs232-536-0Molecular weight50000-8000000AssayGalactomannan content not less than 75 %DescriptionA white to yellowish-white, nearly odourless powderIdentification A. Positive tests for galactose and for mannose B. Solubility Soluble in cold waterPurityLoss on dryingNot more than 15 % (105 oC, 5 hours)AshNot more than 1,5 % determined at 800 oCAcid-insoluble matterNot more than 7 %Protein (N × 6,25)Not more than 10 % StarchNot 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)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kg E 413 TRAGACANTH SynonymsTragacanth gumTragantDefinitionTragacanth 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 presentMolecular weightApproximately 800000Einecs232-252-5DescriptionUnground 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 colourIdentification

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 ethanolPurityNegative test for Karaya gumBoil 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 developsLoss on dryingNot more than 16 % (105 oC, 5 hours)Total ashNot more than 4 %Acid insoluble ashNot more than 0,5 %Acid insoluble matterNot more than 2 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kgSalmonella spp.Negative in 10 gE. coliNegative in 5 g E 414 ACACIA GUM SynonymsGum arabicDefinitionAcacia 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 acidMolecular weightApproximately 350000Einecs232-519-5DescriptionUnground 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 ethanolPurityLoss on dryingNot more than 17 % (105 oC, 5 hours) for granular and not more than 10 % (105 oC, 4 hours) for spray-dried materialTotal ashNot more than 4 %Acid insoluble ashNot more than 0,5 %Acid insoluble matterNot more than 1 %Starch or dextrinBoil 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 producedTanninTo 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 formedArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kgHydrolysis productsMannose, xylose and galacturonic acid are absent (determined by chromatography)Salmonella spp.Negative in 10 gE. coliNegative in 5 g E 415 XANTHAN GUM DefinitionXanthan 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 propane-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 neutralMolecular weightApproximately 1000000Einecs234-394-2AssayYields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gumDescriptionCream-coloured powder

Identification A. Solubility Soluble in water. Insoluble in ethanolPurityLoss on dryingNot more than 15 % (105 oC, 21/2 hours)Total ashNot more than 16 % on the anhydrous basis determined at 650 oC after drying at 105 oC for four hoursPyruvic acidNot less than 1,5 %NitrogenNot more than 1,5 %Ethanol and propan-2-olNot more than 500 mg/kg singly or in combinationLeadNot more than 2 mg/kgTotal plate countNot more than 5000 colonies per gramYeast and mouldNot more than 300 colonies per gramE. coliAbsent in 5 gSalmonella spp.Absent in 10 gXanthomonas campestrisViable cells absent in 1 g E 416 KARAYA-GUM SynonymsKatiloKadayaGum sterculiaSterculiaKaraya, gum karayaKulloKuterraDefinitionKaraya 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 acidEinecs232-539-4DescriptionKaraya 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 acidIdentification A. Solubility Insoluble in ethanol B. Swelling in ethanol solution Karaya gum swells in 60 % ethanol distinguishing it from other gumsPurityLoss on dryingNot more than 20 % (105 oC, 5 hours)Total ashNot more than 8 %Acid insoluble ashNot more than 1 %Acid insoluble matterNot more than 3 %Volatile acidNot less than 10 % (as acetic acid)StarchNot detectableArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kg MercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kgSalmonella spp.Negative in 10 gE. coliNegative in 5 g E 417 TARA GUM DefinitionTara 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)Einecs254-409-6DescriptionA white to white-yellow odourless powderIdentification A. Solubility Soluble in waterInsoluble in ethanol B. Gel formation To an aqueous solution of the sample add small amounts of sodium borate. A gel is formedPurityLoss on dryingNot more than 15 %AshNot more than 1,5 %Acid insoluble matterNot more than 2 %ProteinNot more than 3,5 % (factor N × 5,7)StarchNot detectableArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kg

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E 418 GELLAN GUM DefinitionGellan 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 saltEinecs275-117-5Molecular weightApproximately 500000AssayYields, on the dried basis, not less than 3,3 % and not more than 6,8 % of CO2DescriptionAn off-white powder Identification A. Solubility Soluble in water, forming a viscous solution.Insoluble in ethanolPurityLoss on dryingNot more than 15 % after drying (105 oC, 21/2 hours)NitrogenNot more than 3 %Propane-2-olNot more than 750 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kgTotal plate countNot more than 10000 colonies per gramYeast and mouldNot more than 400 colonies per gramE. coliNegative in 5 gSalmonella spp.Negative in 10 g E 420(i) SORBITOL Purity criteria for this additive are the same as set out for this additive in Annex I to Commission Directive 2008/60/EC OJ L 158, 18.6.2008, p. 17. . E 420(ii) SORBITOL SYRUP Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC. E 421 MANNITOL Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC. E 422 GLYCEROL SynonymsGlycerinGlycerineDefinitionChemical names1,2,3-propanetriolGlycerolTrihydroxypropaneEinecs200-289-5Chemical formulaC3H8O3Molecular weight92,10AssayContent not less than 98 % of glycerol on the anhydrous basisDescriptionClear, 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 oC) Not less than 1,257 C. Refractive index [n]D20 Between 1,471 and 1,474PurityWaterNot more than 5 % (Karl Fischer method)Sulphated ashNot more than 0,01 % determined at 800 ± 25 oCButanetriolsNot more than 0,2 %Acrolein, glucose and ammonium compoundsHeat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide solution (1 in 10) at 60 oC for five minutes. It neither becomes yellow nor emits an odour of ammoniaFatty acids and estersNot more than 0,1 % calculated as butyric acidChlorinated compoundsNot more than 30 mg/kg (as chlorine)ArsenicNot more than 3 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 5 mg/kg

E 425(i) KONJAC GUM DefinitionKonjac gum is a water-soluble hydrocolloid obtained from the Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plant Amorphophallus konjac. The main component of Konjac gum is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds. Shorter side chains are attached through β(1-3)-glycosidic bonds, and acetyl groups occur at random at a ratio of about 1 group per 9 to 19 sugar unitsMolecular weightThe main component, glucomannan, has an average molecular weight of 200000 to 2000000AssayNot less than 75 % carbohydrateDescriptionA white to cream to light tan powderIdentification A. Solubility Dispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0 B. Gel formation Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the sample in a test tube, and shake vigorously. A gel forms C. Formation of heat-stable gel Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed D. Viscosity (1 % solution) Not less than 3 kgm-1s-1 at 25 oCPurityLoss on dryingNot more than 12 % (105 oC, 5 h)StarchNot more than 3 %ProteinNot more than 3 % (N × 5,7)Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample Ether-soluble materialNot more than 0,1 %Total ashNot more than 5,0 % (800 oC, 3 to 4h)ArsenicNot more than 3 mg/kgLeadNot more than 2 mg/kgSalmonella spp.Absent in 12,5 gE. coliAbsent in 5 g E 425(ii) KONJAC GLUCOMANNAN DefinitionKonjac glucomannan is a water-soluble hydrocolloid obtained from Konjac flour by washing with water-containing ethanol. Konjac flour is the unpurified raw product from the tuber of the perennial plant Amorphophallus konjac. The main component is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is acetylatedMolecular weight500000 to 2000000AssayTotal dietary fibre: not less than 95 % on a dry weight basisDescriptionWhite to slightly brownish fine particle size, free flowing and odourless powderIdentification A. Solubility Dispersible in hot or cold water forming a highly viscous solution with a pH between 5,0 and 7,0. Solubility is increased by heat and mechanical agitation B. Formation of heat-stable gel

Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed C. Viscosity (1 % solution) Not less than 20 kgm-1s-1 at 25 oCPurityLoss on dryingNot more than 8 % (105 oC, 3h)StarchNot more than 1 %ProteinNot more than 1,5 % (N × 5,7)Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sampleEther-soluble materialNot more than 0,5 %Sulphite (as SO2)Not more than 4 mg/kgChlorideNot more than 0,02 %50 % Alcohol-solubleNot more than 2,0 % materialTotal ashNot more than 2,0 % (800 oC, 3 to 4h)LeadNot more than 1 mg/kgSalmonella spp.Absent in 12,5 gE. coliAbsent in 5 g E 426 SOYBEAN HEMICELLULOSE DefinitionSoybean hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extractionChemical namesWater soluble soybean polysaccharidesWater soluble soybean fibreAssayNot less than 74 % carbohydrateDescriptionFree flowing spray-dried white powderIdentification A. Solubility pH of 1 % solution Soluble in hot and cold water without gel formation5,5±1,5 B. Viscosity of 10 % solution Not more than 200 mPa.sPurityLoss on dryingNot more than 7 % (105 oC, 4h)ProteinNot more than 14 %Total ashNot more than 9,5 % (600 oC, 4h)ArsenicNot more than 2 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgStandard plate countNot more than 3000 colonies per gramYeast and mouldNot more than 100 colonies per gramE. coliNegative in 10 g E 431 POLYOXYETHYLENE (40) STEARATE SynonymsPolyoxyl (40) stearatepolyoxyethylene (40) monostearateDefinitionA 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 polyolAssayContent not less than 97,5 % on the anhydrous basisDescriptionCream-coloured flakes or waxy solid at 25 oC with a faint odourIdentification A. Solubility Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil B. Congealing range 39 oC-44 oC C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyolPurityWaterNot more than 3 % (Karl Fischer method)Acid valueNot more than 1Saponification valueNot less than 25 and not more than 35Hydroxyl valueNot less than 27 and not more than 401,4-DioxaneNot more than 5 mg/kgEthylene oxideNot more than 0,2 mg/kgEthylene glycols (mono- and di-)Not more than 0,25 %ArsenicNot more than 3 mg/kg LeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kg E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)

SynonymsPolysorbate 20Polyoxyethylene (20) sorbitan monolaurateDefinitionA 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 anhydridesAssayContent not less than 70 % of oxyethylene groups, equivalent to not less than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on the anhydrous basisDescriptionA lemon to amber-coloured oily liquid at 25 oC with a faint characteristic odourIdentification 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 polyolPurityWaterNot more than 3 % (Karl Fischer method)Acid valueNot more than 2Saponification valueNot less than 40 and not more than 50Hydroxyl valueNot less than 96 and not more than 1081,4-dioxaneNot more than 5 mg/kgEthylene oxideNot more than 0,2 mg/kgEthylene glycols (mono- and di-)Not more than 0,25 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kg E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80) SynonymsPolysorbate 80Polyoxyethylene (20) sorbitan monooleateDefinitionA 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 anhydridesAssayContent not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basisDescriptionA lemon to amber-coloured oily liquid at 25 oC with a faint characteristic odourIdentification 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 PurityWaterNot more than 3 % (Karl Fischer method)Acid valueNot more than 2Saponification valueNot less than 45 and not more than 55Hydroxyl valueNot less than 65 and not more than 801,4-dioxaneNot more than 5 mg/kgEthylene oxideNot more than 0,2 mg/kgEthylene glycols (mono- and di-)Not more than 0,25 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kg E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40) SynonymsPolysorbate 40Polyoxyethylene (20) sorbitan monopalmitateDefinitionA 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 anhydridesAssayContent not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basisDescriptionA lemon to orange-coloured oily liquid or semi-gel at 25 oC with a faint characteristic odourIdentification

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 polyolPurityWaterNot more than 3 % (Karl Fischer method)Acid valueNot more than 2Saponification valueNot less than 41 and not more than 52Hydroxyl valueNot less than 90 and not more than 1071,4-dioxaneNot more than 5 mg/kgEthylene oxideNot more than 0,2 mg/kgEthylene glycols (mono- and di-)Not more than 0,25 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kg E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60) SynonymsPolysorbate 60Polyoxyethylene (20) sorbitan monostearateDefinitionA 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 AssayContent not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basisDescriptionA lemon to orange-coloured oily liquid or semi-gel at 25 oC with a faint characteristic odourIdentification 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 polyolPurityWaterNot more than 3 % (Karl Fischer method)Acid valueNot more than 2Saponification valueNot less than 45 and not more than 55Hydroxyl valueNot less than 81 and not more than 961,4-dioxaneNot more than 5 mg/kgEthylene oxideNot more than 0,2 mg/kgEthylene glycols (mono- and di-)Not more than 0,25 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kg E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65) SynonymsPolysorbate 65Polyoxyethylene (20) sorbitan tristearateDefinitionA 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 anhydridesAssayContent not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basisDescriptionA tan-coloured, waxy solid at 25 oC with a faint characteristic odourIdentification A. Solubility Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol B. Congealing range 29-33 oC C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyolPurityWaterNot more than 3 % (Karl Fischer method)Acid valueNot more than 2Saponification valueNot less than 88 and not more than 98Hydroxyl valueNot less than 40 and not more than 601,4-dioxaneNot more than 5 mg/kgEthylene oxideNot more than 0,2 mg/kgEthylene glycols (mono- and di-)Not more than 0,25 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kg

E 440 (i) PECTIN DefinitionPectin 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-olEinecs232-553-0AssayContent not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcoholDescriptionWhite, light yellow, light grey or light brown powderIdentification A. Solubility Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanolPurityLoss on dryingNot more than 12 % (105 oC, 2 hours)Acid insoluble ashNot more than 1 % (insoluble in approximately 3N hydrochloric acid)Sulphur dioxideNot more than 50 mg/kg on the anhydrous basisNitrogen contentNot more than 1,0 % after washing with acid and ethanolFree methanol, ethanol and propane-2-olNot more than 1 %, singly or in combination, on the anhydrous basisArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kg E 440 (ii) AMIDATED PECTIN DefinitionAmidated 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-olAssayContent not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcoholDescriptionWhite, light yellow, light greyish or light brownish powderIdentification A. Solubility Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanolPurityLoss on dryingNot more than 12 % (105 oC, 2 hours)Acid-insoluble ashNot more than 1 % (insoluble in approximately 3N hydrochloric acid)Degree of amidationNot more than 25 % of total carboxyl groupsSulphur dioxide residueNot more than 50 mg/kg on the anhydrous basisNitrogen contentNot more than 2,5 % after washing with acid and ethanolFree methanol, ethanol and propane-2-olNot more than 1 % single or in combination, on a volatile matter-free basisArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg CadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kg E 442 AMMONIUM PHOSPHATIDES SynonymsAmmonium salts of phosphatidic acid, mixed ammonium salts of phoshorylated glyceridesDefinitionA 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 phosphatidesAssayThe 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)DescriptionUnctuous semi-solidIdentification

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 PurityPetroleum ether insoluble matterNot more than 2,5 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 444 SUCROSE ACETATE ISOBUTYRATE SynonymsSAIBDefinitionSucrose 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 2:6Einecs204-771-6Chemical nameSucrose diacetate hexaisobutyrateChemical formulaeC40H62O19Molecular weight832-856 (approximate), C40H62O19: 846,9AssayContent not less than 98,8 % and not more than 101,9 % of C40H62O19DescriptionA pale straw-coloured liquid, clear and free of sediment and having a bland odourIdentification A. Solubility Insoluble in water. Soluble in most organic solvents B. Refractive index [n]40D: 1,4492-1,4504 C. Specific gravity [d]25D: 1,141-1,151PurityTriacetinNot more than 0,1 %Acid valueNot more than 0,2Saponification valueNot less than 524 and not more than 540 ArsenicNot more than 3 mg/kgLeadNot more than 3 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 5 mg/kg E 445 GLYCEROL ESTERS OF WOOD ROSIN SynonymsEster gumDefinitionA 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 distillationDescriptionHard, yellow to pale amber-coloured solidIdentification A. Solubility Insoluble in water, soluble in acetone B. Infrared absorption spectrum Characteristic of the compoundPuritySpecific gravity of solution[d]2025 not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, boilding point 175,5-176 oC, d204: 0,84)Ring and ball softening rangeBetween 82 oC and 90 oCAcid valueNot less than 3 and not more than 9Hydroxyl valueNot less than 15 and not more than 45ArsenicNot more than 3 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgTest 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 SynonymsDisodium dihydrogen diphosphateDisodium dihydrogen pyrophosphateSodium acid pyrophosphateDisodium pyrophosphateDefinitionChemical nameDisodium dihydrogen diphosphateEinecs231-835-0Chemical formulaNa2H2P2O7 Molecular weight221,94AssayContent not less than 95 % of disodium diphosphateP2O5 ContentNot less than 63,0 % and not more than 64,5 %DescriptionWhite powder or grainsIdentification A. Positive tests for sodium and for phosphate B. Solubility Soluble in water C. pH of a 1 % solution Between 3,7 and 5,0PurityLoss on dryingNot more than 0,5 % (105 oC, four hours)Water-insoluble matterNot more than 1 %FluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 450 (ii) TRISODIUM DIPHOSPHATE SynonymsAcid trisodium pyrophosphateTrisodium monohydrogen diphosphateDefinitionEinecs238-735-6Chemical formulaMonohydrate: Na3HP2O7 · H2OAnhydrous: Na3HP2O7Molecular weightMonohydrate: 261,95Anhydrous: 243,93AssayContent not less than 95 % on the anhydrous basisP2O5 contentNot less than 57 % and not more than 59 %DescriptionWhite powder or grains, occurs anhydrous or as a monohydrateIdentification A. Positive tests for sodium and for phosphate B. Solubility Soluble in water C. pH of a 1 % solution Between 6,7 and 7,5PurityLoss on ignitionNot more than 4,5 % on the anhydrous compoundNot more than 11,5 % on the monohydrous basisLoss on dryingNot more than 0,5 % (105 oC, four hours)Water-insoluble matterNot more than 0,2 %FluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 450 (iii) TETRASODIUM DIPHOSPHATE SynonymsTetrasodium pyrophosphateSodium pyrophosphateDefinitionChemical nameTetrasodium diphosphateEinecs231-767-1Chemical formulaAnhydrous: Na4P2O7Decahydrate: Na4P2O7 · 10H2OMolecular weightAnhydrous: 265,94Decahydrate: 446,09AssayContent not less than 95 % of Na4P2O7 on the ignited basisP2O5 contentNot less than 52,5 % and not more than 54,0 %DescriptionColourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces slightly in dry airIdentification 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 10,8PurityLoss on ignitionNot 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 oC for four hours, followed by ignition at 550 oC for 30 minutesWater-insoluble matterNot more than 0,2 %FluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 450 (v) TETRAPOTASSIUM DIPHOSPHATE SynonymsPotassium pyrophosphateTetrapotassium pyrophosphateDefinitionChemical nameTetrapotassium diphosphateEinecs230-785-7Chemical formulaK4P2O7Molecular weight330,34 (anhydrous)AssayContent not less than 95 % on the ignited basisP2O5 contentNot less than 42,0 % and not more than 43,7 % on the anhydrous basisDescriptionColourless crystals or white, very hygroscopic powderIdentification

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 PurityLoss on ignitionNot more than 2 % after drying at 105 oC for four hours and then ignition at 550 oC for 30 minutesWater-insoluble substancesNot more than 0,2 %FluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 450 (vi) DICALCIUM DIPHOSPHATE SynonymsCalcium pyrophosphateDefinitionChemical nameDicalcium diphosphateDicalcium pyrophosphateEinecs232-221-5Chemical formulaCa2P2O7Molecular weight254,12AssayContent not less than 96 %P2O5 contentNot less than 55 % and not more than 56 %DescriptionA fine, white, odourless powderIdentification 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 7,0PurityLoss on ignitionNot more than 1,5 % at 800 oC ± 25 oC for 30 minutesFluorideNot more than 50 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE SynonymsAcid calcium pyrophosphateMonocalcium dihydrogen pyrophosphateDefinitionChemical nameCalcium dihydrogen diphosphateEinecs238-933-2Chemical formulaCaH2P2O7Molecular weight215,97AssayContent not less than 90 % on the anhydrous basisP2O5 contentNot less than 61 % and not more than 64 % DescriptionWhite crystals or powderIdentification A. Positive tests for calcium and for phosphate PurityAcid-insoluble matterNot more than 0,4 %FluorideNot more than 30 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 451 (i) PENTASODIUM TRIPHOSPHATE SynonymsPentasodium tripolyphosphateSodium tripolyphosphateDefinitionChemical namePentasodium triphosphateEinecs231-838-7Chemical formulaNa5O10P3 · nH2O (n = 0 or 6)Molecular weight367,86AssayContent not less than 85,0 % (anhydrous) or 65,0 % (hexahydrate)P2O5 contentNot less than 56 % and not more than 59 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate)DescriptionWhite, slightly hygroscopic granules or powderIdentification 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 10,2PurityLoss on dryingAnhydrous: Not more than 0,7 % (105 oC, one hour)Hexahydrate: Not more than 23,5 % (60 oC, one hour, followed by drying at 105 oC, four hours)Water-insoluble substancesNot more than 0,1 %Higher polyphosphatesNot more than 1 %FluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE SynonymsPentapotassium tripolyphosphatePotassium triphosphatePotassium tripolyphosphate

DefinitionChemical namePentapotassium triphosphatePentapotassium tripolyphosphateEinecs237-574-9Chemical formulaK5O10P3Molecular weight448,42AssayContent not less than 85 % on the anhydrous basisP2O5 contentNot less than 46,5 % and not more than 48 %DescriptionWhite, very hygroscopic powder or granulesIdentification A. Solubility Very soluble in water B. Positive tests for potassium and for phosphate C. pH of a 1 % solution Between 9,2 and 10,5PurityLoss on ignitionNot more than 0,4 % (after drying at 105 oC, four hours, followed by ignition at 550 oC, 30 minutes)Water-insoluble matterNot more than 2 %FluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 452 (i) SODIUM POLYPHOSPHATE

SOLUBLE POLYPHOSPHATE SynonymsSodium hexametaphosphateSodium tetrapolyphosphateGraham's saltSodium polyphosphates, glassySodium polymetaphosphateSodium metaphosphateDefinitionSoluble 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 9,0Chemical nameSodium polyphosphateEinecs272-808-3Chemical formulaHeterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where n is not less than 2Molecular weight(102)nAssay P2O5 contentNot less than 60 % and not more than 71 % on the ignited basis DescriptionColourless or white, transparent platelets, granules, or powdersIdentification A. Solubility Very soluble in water B. Positive tests for sodium and for phosphate C. pH of a 1 % solution Between 3,0 and 9,0PurityLoss on ignitionNot more than 1 %Water-insoluble matterNot more than 0,1 %FluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg
INSOLUBLE POLYPHOSPHATE SynonymsInsoluble sodium metaphosphateMaddrell's saltInsoluble sodium polyphosphate, IMPDefinitionInsoluble 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 6,5Chemical nameSodium polyphosphateEinecs272-808-3Chemical formulaHeterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where n is not less than 2Molecular weight(102)nP2O5 contentNot less than 68,7 % and not more than 70,0 %DescriptionWhite crystalline powderIdentification

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 6,5PurityFluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 452 (ii) POTASSIUM POLYPHOSPHATE SynonymsPotassium metaphosphatePotassium polymetaphosphateKurrol saltDefinitionChemical namePotassium polyphosphateEinecs232-212-6Chemical formula(KPO3)nHeterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where n is not less than 2Molecular weight(118)nP2O5 contentNot less than 53,5 % and not more than 61,5 % on the ignited basisDescriptionFine white powder or crystals or colourless glassy plateletsIdentification 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 7,8PurityLoss on ignitionNot more than 2 % (105 oC, four hours followed by ignition at 550 oC, 30 minutes)Cyclic phosphateNot more than 8 % on P2O5 contentFluorideNot more than 10 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 452(iii) SODIUM CALCIUM POLYPHOSPHATE SynonymSodium calcium polyphosphate, glassyDefinitionChemical nameSodium calcium polyphosphateEinecs233-782-9Chemical formula(NaPO3)n CaO where n is typically 5AssayNot less than 61 % and not more than 69 % as P2O5DescriptionWhite glassy crystals, spheresIdentification A. pH of a 1 % m/m slurry Approximately 5 to 7 B. CaO content 7 %-15 % m/mPurityFluorideNot more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 4 mg/kgCadmiumNot more than 1 mg/kgMercuryNot more than 1 mg/kg E 452 (iv) CALCIUM POLYPHOSPHATE SynonymsCalcium metaphosphateCalcium polymetaphosphateDefinitionChemical nameCalcium polyphosphateEinecs236-769-6Chemical formula(CaP2O6)nHeterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1) where n is not less than 2Molecular weight(198)nP2O5 contentNot less than 71 % and not more than 73 % on the ignited basisDescriptionOdourless, colourless crystals or white powderIdentification 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 %PurityLoss on ignitionNot more than 2 % (105 oC, four hours followed by ignition at 550 oC, 30 minutes)Cyclic phosphateNot more than 8 % on P2O5 contentFluorideNot more than 30 mg/kg (expressed as fluorine)ArsenicNot more than 3 mg/kgCadmiumNot more than 1 mg/kgLeadNot more than 4 mg/kgMercuryNot more than 1 mg/kg E 459 BETA-CYCLODEXTRIN DefinitionBeta-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 starchChemical nameCycloheptaamyloseEinecs231-493-2Chemical formula(C6H10O5)7Molecular weight1135AssayContent not less than 98,0 % of (C6H10O5)7 on an anhydrous basisDescriptionVirtually odourless white or almost white crystalline solidIdentification

A. Solubility Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol B. Specific rotation [α]25D: + 160o to + 164o (1 % solution)PurityWaterNot more than 14 % (Karl Fischer method)Other cyclodextrinsNot more than 2 % on an anhydrous basisResidual solvents (toluene and trichloroethylene)Not more than 1 mg/kg for each solvent Sulphated ashNot more than 0,1 %ArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kg E 460 (i) MICROCRISTALLINE CELLULOSE SynonymsCellulose gelDefinitionMicrocrystalline 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 400Chemical nameCelluloseEinecs232-674-9Chemical formula(C6H10O5)nMolecular weightAbout 36000AssayNot less than 97 % calculated as cellulose on the anhydrous basisDescriptionA fine white or almost white odourless powderIdentification 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 (12000 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 appearsPurityLoss on dryingNot more than 7 % (105 oC, 3 hours)Water-soluble matterNot more than 0,24 %Sulphated ashNot more than 0,5 % determined at 800 ± 25 oCpH of a 10 % suspension in waterThe pH of the supernatant liquid is between 5,0 and 7,5StarchNot detectableTo 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 producedParticle sizeNot less than 5 μm (not more than 10 % of particles of less than 5 μm)Carboxyl groupsNot more than 1 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 460 (ii) POWDERED CELLULOSE DefinitionPurified, mechanically disintegrated celluslose prepared by processing alpha-cellulose obtained as a pulp from natural strains of fibrous plant materialsChemical nameCelluloseLinear polymer of 1:4 linked glucose residuesEinecs232-674-9Chemical formula(C6H10O5)nMolecular weight(162)n (n is predominantly 1000 and greater)AssayContent not less than 92 %DescriptionA white, odourless powderIdentification 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 (12000 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 settle and a supernatant liquid appearsPurityLoss on dryingNot more than 7 % (105 oC, 3 hours)Water-soluble matterNot more than 1,0 %Sulphated ashNot more than 0,3 % determined at 800 ± 25 oCpH of a 10 % suspension in waterThe pH of the supernatant liquid is between 5,0 and 7,5StarchNot detectableTo 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 producedArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgParticle sizeNot less than 5 μm (not more than 10 % of particles of less than 5 μm) E 461 METHYL CELLULOSE SynonymsCellulose methyl etherDefinitionMethyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groupsChemical nameMethyl ether of celluloseChemical formulaThe 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 weightFrom about 20000 to 380000AssayContent not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)DescriptionSlightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powderIdentification A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution.Insoluble in ethanol, ether and chloroform.Soluble in glacial acetic acidPurityLoss on dryingNot more than 10 % (105 oC, 3 hours)Sulphated ashNot more than 1,5 % determined at 800 ± 25 oCpH of a 1 % colloidal solutionNot less than 5,0 and not more than 8,0ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kg E 462 ETHYL CELLULOSE SynonymsCellulose ethyl etherDefinitionEthyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groupsChemical nameEthyl ether of celluloseChemical formulaThe 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 AssayContent 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)DescriptionSlightly hygroscopic white to off-white, odourless and tasteless powderIdentification

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 flammablePurityLoss on dryingNot more than 3 % (105 oC, 2 hours)Sulphated ashNot more than 0,4 % pH of a 1 % colloidal solutionNeutral to litmusArsenicNot more than 3 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kg E 463 HYDROXYPROPYL CELLULOSE SynonymsCellulose hydroxypropyl etherDefinitionHydroxypropylcellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with hydroxypropyl groupsChemical nameHydroxypropyl ether of celluloseChemical formulaThe 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 weightFrom about 30000 to 1000000AssayContent not less than 80,5 % of hydroxypropoxyl groups (-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basisDescriptionSlightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powderIdentification A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether B. Gas chromatography Determine the substituents by gas chromotographyPurityLoss on dryingNot more than 10 % (105 oC, 3 hours)Sulphated ashNot more than 0,5 % determined at 800 ± 25 oCpH of a 1 % colloidal solutionNot less than 5,0 and not more than 8,0Propylene chlorohydrinsNot more than 0,1 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kg E 464 HYDROXYPROPYL METHYL CELLULOSE DefinitionHydroxypropyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitutionChemical name2-Hydroxypropyl ether of methylcellulose Chemical formulaThe 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 weightFrom about 13000 to 200000AssayContent 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 basisDescriptionSlightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powderIdentification A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol B. Gas chromatography Determine the substituents by gas chromatographyPurityLoss on dryingNot more than 10 % (105 oC, 3 hours)Sulphated ashNot more than 1,5 % for products with viscosities of 50 mPa.s or aboveNot more than 3 % for products with viscosities below 50 mPa.spH of a 1 % colloidal solutionNot less than 5,0 and not more than 8,0Propylene chlorohydrinsNot more than 0,1 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kg E 465 ETHYL METHYL CELLULOSE SynonymsMethylethylcelluloseDefinitionEthyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl and ethyl groupsChemical nameEthyl methyl ether of celluloseChemical formulaThe 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 weightFrom about 30000 to 40000 AssayContent 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 methoxylDescriptionSlightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powderIdentification A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in etherPurityLoss on dryingNot more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 oC to constant weight)Sulphated ashNot more than 0,6 %pH of a 1 % colloidal solutionNot less than 5,0 and not more than 8,0ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kg E 466 SODIUM CARBOXY METHYL CELLULOSE SynonymsCarboxy methyl celluloseCMCNaCMCSodium CMCCellulose gumDefinitionCarboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from natural strains of fibrous plant materialChemical nameSodium salt of the carboxymethyl ether of celluloseChemical formulaThe 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 weightHigher than approximately 17000 (degree of polymerisation approximately 100)AssayContent on the anhydrous basis not less than 99,5 %DescriptionSlightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powderIdentification A. Solubility Yields a viscous colloidal solution with water. Insoluble in ethanol B. Foam test A 0,1 % solution of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers) C. Precipitate formation To 5 ml of a 0,5 % solution 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) D. Colour reaction Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce an uniform dispersion. Continue the stirring until a clear solution is produced, and use the solution 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 PurityDegree of substitutionNot less than 0,2 and not more than 1,5 carboxymethyl groups (-CH2COOH) per anhydroglucose unitLoss on dryingNot more than 12 % (105 oC to constant weight)pH of a 1 % colloidal solutionNot less than 5,0 and not more than 8,5ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 20 mg/kgTotal glycolateNot more than 0,4 %, calculated as sodium glycolate on the anhydrous basisSodiumNot more than 12,4 % on the anhydrous basis E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE SynonymsCross-linked carboxymethyl celluloseCross-linked CMCCross-linked sodium CMCCross-linked cellulose gumDefinitionCross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated celluloseChemical nameSodium salt of the cross-linked carboxymethyl ether celluloseChemical formulaThe 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 DescriptionSlightly hygroscopic, white to off white, odourless powderIdentificationA.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 massB.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 interfaceC.It gives the reaction of sodium

PurityLoss on dryingNot more than 6 % (105 oC, 3h)Water solublesNot more than 10 %Degree of substitutionNot less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unitpH of 1 %Not less than 5,0 and not more than 7,0Sodium contentNot more than 12,4 % on anhydrous basisArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgCadmiumNot more than 1 mg/kgMercuryNot more than 1 mg/kg E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE SynonymsSodium carboxymethyl cellulose, enzymatically hydrolysedDefinitionEnzymatically hydrolysed carboxymethylcellulose is obtained from carboxymethylcellulose by enzymatic digestion with a cellulase produced by Trichoderma longibrachiatum (formerly T. reesei)Chemical nameCarboxymethyl cellulose, sodium, partially enzymatically hydrolysedChemical formulaSodium salts of polymers containing substituted anhydroglucose units with the general formula:[C6H7O2(OH)x(OCH2COONa)y]nwhere n is the degree of polymerisationx = 1,50 to 2,80y = 0,2 to 1,50x + y = 3,0(y = degree of substitution)Formula weight178,14 where y = 0,20282,18 where y = 1,50Macromolecules: Not less than 800 (n about 4)AssayNot less than 99,5 %, including mono- and disaccharides, on the dried basisDescriptionWhite or slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous powderIdentification A. Solubility Soluble in water, insoluble in ethanol B. Foam test Vigorously shake a 0,1 % solution 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 C. Precipitate formation To 5 ml of a 0,5 % solution 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 D. 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 solution is produced. Dilute 1 ml of the solution 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 E. Viscosity (60 % solids) Not less than 2,500 kgm-1s-1 at 25 oC corresponding to an average molecule weight of 5000 D PurityLoss on dryingNot more than 12 % (105 oC to constant weight)Degree of substitutionNot less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit on the dried basispH of a 1 % colloidal solutionNot less than 6,0 and not more than 8,5Sodium chloride and sodium glycolateNot more than 0,5 % singly or in combinationResidual enzyme activityPasses test. No change in viscosity of test solution occurs, which indicates hydrolysis of the sodium carboxymethyl celluloseLeadNot more than 3 mg/kg

E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDS DefinitionSodium, 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 acidsAssayContent on the anhydrous basis not less than 95 %DescriptionWhite or creamy white light powders, flakes or semi-solidsIdentification A. Solubility Sodium and potassium salts: soluble in water and ethanol calcium salts:insoluble in water, ethanol and ether B. Positive tests for cations and for fatty acids PuritySodiumNot less than 9 % and not more than 14 % expressed as Na2OPotassiumNot less than 13 % and not more than 21,5 % expressed as K2OCalciumNot less than 8,5 % and not more than 13 % expressed as CaOUnsaponifiable matterNot more than 2 %Free fatty acidsNot more than 3 % estimated as oleic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgFree alkaliNot more than 0,1 % expressed as NaOHMatter insoluble in alcoholNot more than 0,2 % (sodium and potassium salts only) E 470b MAGNESIUM SALTS OF FATTY ACIDS DefinitionMagnesium 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 acidsAssayContent on the anhydrous basis not less than 95 %DescriptionWhite or creamy-white light powders, flakes or semi-solidsIdentification A. Solubility Insoluble in water, partially soluble in ethanol and ether B. Positive tests for magnesium and for fatty acids PurityMagnesiumNot less than 6,5 % and not more than 11 % expressed as MgOFree alkaliNot more than 0,1 % expressed as MgOUnsaponifiable matterNot more than 2 %Free fatty acidsNot more than 3 % estimated as oleic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS Note: 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). SynonymsGlyceryl monostearateGlyceryl monopalmitateGlyceryl monooleate, etc.Monostearin, monopalmitin, monoolein, etc.GMS (for glyceryl monostearate)DefinitionMono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerolAssayContent of mono- and diesters: not less than 70 %DescriptionThe 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 beadsIdentification A. Infrared spectrum Characteristic of a partial fatty acid ester of a polyol B. Positive tests for glycerol and for fatty acids C. Solubility Insoluble in water, soluble in ethanol and toluenePurityWater contentNot more than 2 % (Karl Fischer method)Acid valueNot more than 6Free glycerolNot more than 7 %PolyglycerolsNot more than 4 % diglycerol and not more than 1 % higher polyglycerols both based on total glycerol contentArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgTotal glycerolNot less than 16 % and not more than 33 %Sulphated ashNot more than 0,5 % determined at 800 ± 25 oC

E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Note: 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). SynonymsAcetic acid esters of mono- and diglyceridesAcetoglyceridesAcetylated mono- and diglyceridesAcetic and fatty acid esters of glycerolDefinitionEsters 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 glyceridesDescriptionClear, mobile liquids to solids, from white to pale yellow in colourIdentification A. Positive tests for glycerol, for fatty acids and for acetic acid B. Solubility Insoluble in water. Soluble in ethanolPurityAcids other than acetic and fatty acidsNot detectableFree glycerolNot more than 2 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgTotal acetic acidNot less than 9 % and not more than 32 %Free fatty acids (and acetic acid)Not more than 3 % estimated as oleic acidTotal glycerolNot less than 14 % and not more than 31 %Sulphated ashNot more than 0,5 % determined at 800 ± 25 oC E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Note: 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). SynonymsLactic acid esters of mono- and diglyceridesLactoglyceridesMono- and diglycerides of fatty acids esterified with lactic acidDefinitionEsters 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 glyceridesDescriptionClear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colourIdentification A. Positive tests for glycerol, for fatty acids and for lactic acid B. Solubility Insoluble in cold water but dispersible in hot waterPurityAcids other than lactic and fatty acidsNot detectableFree glycerolNot more than 2 %ArsenicNot more than 3 mg/kg LeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgTotal lactic acidNot less than 13 % and not more than 45 %Free fatty acids (and lactic acid)Not more than 3 % estimated as oleic acidTotal glycerolNot less than 13 % and not more than 30 %Sulphated ashNot more than 0,5 % determined at 800 ± 25 oC E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Note: 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). SynonymsCitremCitric acid esters of mono- and diglyceridesCitroglyceridesMono- and diglycerides of fatty acids esterified with citric acidDefinitionEsters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium hydroxide or with potassium hydroxideDescriptionYellowish or light brown liquids to waxy solids or semi-solidsIdentification

A. Positive tests for glycerol, for fatty acids and for citric acid B. Solubility Insoluble in cold waterDispersible in hot waterSoluble in oils and fatsInsoluble in cold ethanolPurityAcids other than citric and fatty acidsNot detectableFree glycerolNot more than 2 %Total glycerolNot less than 8 % and not more than 33 %Total citric acidNot less than 13 % and not more than 50 %Sulphated ash (determined at 800 ± 25 oC)Non-neutralised products: not more than 0,5 %Partially or wholly neutralised products: not more than 10 %LeadNot more than 2 mg/kgFree fatty acidsNot more than 3 % estimated as oleic acid E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Note: 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). SynonymsTartaric acid esters of mono- and diglyceridesMono- and diglycerides of fatty acids esterified with tartaric acidDefinitionEsters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides DescriptionSticky viscous yellowish liquids to hard yellow waxesIdentification A. Positive tests for glycerol, for fatty acids and for tartaric acid PurityAcids other than tartaric and fatty acidsNot detectableFree glycerolNot more than 2 %Total glycerolNot less than 12 % and not more than 29 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgTotal tartaric acidNot less than 15 % and not more than 50 %Free fatty acidsNot more than 3 % estimated as oleic acidSulphated ashNot more than 0,5 % determined at 800 ± 25 oC E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Note: 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). SynonymsDiacetyltartaric acid esters of mono- and diglyceridesMono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acidDiacetyltartaric and fatty acid esters of glycerolDefinitionMixted esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acidsDescriptionSticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acidIdentification A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid PurityAcids other than acetic, tartaric and fatty acidsNot detectableFree glycerolNot more than 2 %Total glycerolNot less than 11 % and not more than 28 %Sulphated ashNot more than 0,5 % determined at 800 ± 25 oCArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgTotal tartaric acidNot less than 10 % and not more than 40 %

Total acetic acidNot less than 8 % and not more than 32 %Free fatty acidsNot more than 3 % estimated as oleic acid E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Note: 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). SynonymsMono- and diglycerides of fatty acids esterified with acetic acid and tartaric acidDefinitionEsters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and ecetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acidsDescriptionSticky liquids to solids, from white to pale-yellow in colourIdentification A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid PurityAcids other than acetic, tartaric and fatty acidsNot detectableFree glycerolNot more than 2 %Total glycerolNot less than 12 % and not more than 27 %Sulphated ashNot more than 0,5 % determined at 800 ± 25 oCArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgTotal acetic acidNot less than 10 % and not more than 20 %Total tartaric acidNot less than 20 % and not more than 40 %Free fatty acidsNot more than 3 % estimated as oleic acid E 473 SUCROSE ESTERS OF FATTY ACIDS Note: 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). SynonymsSucroestersSugar estersDefinitionEssentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl and ethyl esters of food fatty acids or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propane-2-ol, 2-methyl-1-propanol, propylene glycol and methyl ethyl ketone may be used for their preparationAssayContent not less than 80 %DescriptionStiff gels, soft solids or white to slightly greyish-white powdersIdentification A. Positive tests for sugar for fatty acids B. Solubility Sparingly soluble in waterSoluble in ethanolPuritySulphated ashNot more than 2 % determined at 800 ± 25 oCFree sugarNot more than 5 %Free fatty acidsNot more than 3 % estimated as oleic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgMethanolNot more than 10 mg/kgDimethylsulphoxideNot more than 2 mg/kgDimethylformamideNot more than 1 mg/kg2-methyl-1-propanolNot more than 10 mg/kgEthylacetateNot more than 350 mg/kg, singly or in combinationPropane-2-olProlyleneglycolMethyl ethyl ketoneNot more than 10 mg/kg

E 474 SUCROGLYCERIDES Note: 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). SynonymsSugar glyceridesDefinitionSucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propane-2-olAssayContent not less than 40 % and not more than 60 % of sucrose fatty acid estersDescriptionSoft solid masses, stiff gels or white to off-white powdersIdentification A. Positive tests for sugar and for fatty acids B. Solubility Insoluble in cold waterSoluble in ethanolPuritySulphated ashNot more than 2 % determined at 800 ± 25 oCFree sugarNot more than 5 %Free fatty acidsNot more than 3 % estimated as oleic acidArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgMethanolNot more than 10 mg/kgDimethylformamideNot more than 1 mg/kg 2-methyl-1-propanolNot more than 10 mg/kg, single or in combinationCyclohexaneEthylacetateNot more than 350 mg/kg, single or in combinationPropane-2-ol E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS Note: 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). SynonymsPolyglycerol fatty acid estersPolyglycerin esters of fatty acid estersDefinitionPolyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerolAssayContent of total fatty acid ester not less than 90 %DescriptionLight yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solidsIdentification A. Positive tests for glycerol, for polyglycerols and for fatty acids B. Solubility The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oilsPuritySulphated ashNot more than 0,5 % determined at 800 ± 25 oCAcids other than fatty acidsNot detectableFree fatty acidsNot more than 6 % estimated as oleic acidTotal glycerol and polyglycerolNot less than 18 % and not more than 60 %Free glycerol and polyglycerolNot more than 7 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 476 POLYGLYCEROL POLYRICINOLEATE

SynonymsGlycerol esters of condensed castor oil fatty acidsPolyglycerol esters of polycondensed fatty acids from castor oilPolyglycerol esters of interesterified ricinoleic acidPGPRDefinitionPolyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acidsDescriptionClear, highly viscous liquid Identification A. Solubility Insoluble in water and in ethanol.Soluble in ether, hydrocarbons and halogenated hydrocarbons B. Positive tests for glycerol, polyglycerol and for ricinoleic acid C. Refractive index [n]65 Between 1,4630 and 1,4665PurityPolyglycerolsThe polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerolHydroxyl valueNot less than 80 and not more than 100Acid valueNot more than 6ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDS Note: 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). SynonymsPropylene glycol esters of fatty acidsDefinitionConsists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absentAssayContent of total fatty acid ester not less than 85 %DescriptionClear liquids or waxy white flakes, beads or solids having a bland odourIdentification A. Positive tests for propylene glycol and for fatty acids PuritySulphated ashNot more than 0,5 % determined at 800 ± 25 oCAcids other than fatty acidsNot detectableFree fatty acidsNot more than 6 % estimated as oleic acidTotal propane-1,2-diolNot less than 11 % and not more than 31 %Free propane-1,2-diolNot more than 5 %Dimer and trimer of propylene glycolNot more than 0,5 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF FATTY ACIDS SynonymsTOSOMDefinitionThermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and desodorisation under vacuum at 130 oC of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from natural strains of soya beansDescriptionPale yellow to light brown a waxy or solid consistencyIdentification A. Solubility Insoluble in water. Soluble in hot oil or fatPurityMelting range55-65 oCFree fatty acidsNot more than 1,5 % estimated as oleic acidFree glycerolNot more than 2 %Total fatty acids83-90 %Total glycerol16-22 %Fatty acid methyl esters, not forming adduct with ureaNot more than 9 % of total fatty acid methyl estersFatty acids, insoluble in petroleum etherNot more than 2 % of total fatty acidsPeroxide valueNot more than 3EpoxidesNot more than 0,03 % oxirane oxygenArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg

E 481 SODIUM STEAROYL-2-LACTYLATE SynonymsSodium stearoyl lactylateSodium stearoyl lactateDefinitionA mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid usedChemical namesSodium di-2-stearoyl lactateSodium di(2-stearoyloxy)propionateEinecs246-929-7Chemical formula (major components)C21H39O4NaC19H35O4NaDescriptionWhite or slightly yellowish powder or brittle solid with a characteristic odourIdentification A. Positive tests for sodium, for fatty acids and for lactic acid B. Solubility Insoluble in water. Soluble in ethanol PuritySodiumNot less than 2,5 % and not more than 5 %Ester valueNot less than 90 and not more than 190Acid valueNot less than 60 and not more than 130Total lactic acidNot less than 15 % and not more than 40 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 482 CALCIUM STEAROYL-2-LACTYLATE SynonymsCalcium stearoyl lactateDefinitionA mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid usedChemical nameCalcium di-2-stearoyl lactateCalcium di(2-stearoyloxy)propionateEinecs227-335-7Chemical formulaC42H78O8CaC38H70O8CaDescriptionWhite or slightly yellowish powder or brittle solid with a characteristic odourIdentification A. Positive tests for calcium, for fatty acids and for lactid acid B. Solubility Slightly soluble in hot waterPurityCalciumNot less than 1 % and not more than 5,2 %Ester valueNot less than 125 and not more than 190Total lactic acidNot less than 15 % and not more than 40 %Acid valueNot less than 50 and not more than 130ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 483 STEARYL TARTRATE SynonymsStearyl palmityl tartrateDefinitionProduct of the esterification of tartaric acid with commercial stearyl alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materialsChemical nameDistearyl tartrateDipalmityl tartrate Chemical formulaC38H74O6 to C40H78O6Molecular weight627 to 655AssayContent of total ester not less than 90 % corresponding to an ester value of not less than 163 and not more than 180DescriptionCream-coloured unctuous solid (at 25 oC)Identification A. Positive tests for tartare B. Melting range Between 67 oC and 77 oC. After saponification the saturated long chain fatty alcohols have a melting range of 49 oC to 55 oCPurityHydroxyl valueNot less than 200 and not more than 220Acid valueNot more than 5,6Total tartaric acid contentNot less than 18 % and not more than 35 %Sulphated ashNot more than 0,5 % determined at 800 ± 25 oCArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgUnsaponifiable matterNot less than 77 % and not more than 83 %Iodine valueNot more than 4 (Wijs method)

E 491 SORBITAN MONOSTEARATE DefinitionA mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acidEinecs215-664-9AssayContent not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide estersDescriptionLight, cream- to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odourIdentification A. Solubility Soluble at temperatures above its melting point in toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in petroleum ether and acetone; insoluble in cold water but dispersible in warm water; soluble with haze at temperatures above 50 oC in mineral oil and ethyl acetate B. Congealing range 50-52 oC C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyolPurityWaterNot more than 2 % (Karl Fischer method)Sulphated ashNot more than 0,5 %Acid valueNot more than 10Saponification valueNot less than 147 and not more than 157Hydroxyl valueNot less than 235 and not more than 260ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 492 SORBITAN TRISTEARATE DefinitionA mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acidEinecs247-891-4AssayContent not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide estersDescriptionLight, cream- to tan-coloured beads or flakes or hard, waxy solid with a slight odourIdentification A. Solubility Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether, mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol B. Congealing range 47-50 oC C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyolPurityWaterNot more than 2 % (Karl Fischer method)Sulphated ashNot more than 0,5 %Acid valueNot more than 15Saponification valueNot less than 176 and not more than 188Hydroxyl valueNot less than 66 and not more than 80ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 493 SORBITAN MONOLAURATE DefinitionA mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acidEinecs215-663-3AssayContent not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide estersDescriptionAmber-coloured oily viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight odourIdentification A. Solubility Dispersible in hot and cold water B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyolPurityWaterNot more than 2 % (Karl Fischer method)Sulphated ashNot more than 0,5 %Acid valueNot more than 7Saponification valueNot less than 155 and not more than 170Hydroxyl valueNot less than 330 and not more than 358ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg

E 494 SORBITAN MONOOLEATE DefinitionA mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleateEinecs215-665-4AssayContent not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide estersDescriptionAmber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odourIdentification A. Solubility Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water, dispersible in warm water B. Iodine value The residue of oleic acid, obtained from the saponification of the sorbitan monoleate in assay, has a iodine value between 80 and 100PurityWaterNot more than 2 % (Karl Fischer method)Sulphated ashNot more than 0,5 %Acid valueNot more than 8Saponification valueNot less than 145 and not more than 160Hydroxyl valueNot less than 193 and not more than 210ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 495 SORBITAN MONOPALMITATE SynonymsSorbitan palmitateDefinitionA mixture of the partial esters of sorbitol and its anhydrides with edible, commercial palmitic acidEinecs247-568-8AssayContent not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide estersDescriptionLight cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odourIdentification A. Solubility Soluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water B. Congealing range 45-47 oC C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of polyolPurityWaterNot more than 2 % (Karl Fischer method)Sulphate ashNot more than 0,5 %Acid valueNot more than 7,5Saponification valueNot less than 140 and not more than 150Hydroxyl valueNot less than 270 and not more than 305ArsenicNot more than 3 mg/kg LeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 500(i) SODIUM CARBONATE SynonymsSoda ashDefinitionChemical nameSodium carbonateEinecs207-838-8Chemical formulaNa2CO3 · nH2O (n = 0, 1 or 10)Molecular weight106,00 (anhydrous)AssayContent not less than 99 % of Na2CO3 on the anhydrous basisDescriptionColourless crystals or white, granular or crystalline powderThe anhydrous form is hygroscopic, the decahydrate efflorescentIdentification A. Positive tests for sodium and for carbonate B. Solubility Freely soluble in water. Insoluble in ethanolPurityLoss on dryingNot more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % (decahydrate) (70 oC raising gradually to 300 oC, to constant weight)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg

E 500(ii) SODIUM HYDROGEN CARBONATE SynonymsSodium bicarbonate, sodium acid carbonate, bicarbonate of soda, baking sodaDefinitionChemical nameSodium hydrogen carbonateEinecs205-633-8Chemical formulaNaHCO3Molecular weight84,01AssayContent not less than 99 % on the anhydrous basisDescriptionColourless or white crystalline masses or crystalline powderIdentification A. Positive tests for sodium and for carbonate B. pH of a 1 % solution Between 8,0 and 8,6 C. Solubility Soluble in water. Insoluble in ethanolPurityLoss on dryingNot more than 0,25 % (over silica gel, 4h)Ammonium saltsNo odour of ammonia detectable after heating ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 500(iii) SODIUM SESQUICARBONATE DefinitionChemical nameSodium monohydrogen dicarbonateEinecs208-580-9Chemical formulaNa2(CO)3 · NaHCO3 · 2H2OMolecular weight226,03AssayContent between 35,0 % and 38,6 % of NaHCO3 and between 46,4 % and 50,0 % of Na2CO3DescriptionWhite flakes, crystals or crystalline powderIdentification A. Positive tests for sodium and for carbonate B. Solubility Freely soluble in waterPuritySodium chlorideNot more than 0,5 %IronNot more than 20 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 501(i) POTASSIUM CARBONATE DefinitionChemical namePotassium carbonateEinecs209-529-3Chemical formulaK2CO3 · nH2O (n = 0 or 1,5)Molecular weight138,21 (anhydrous)AssayContent not less than 99,0 % on the anhydrous basisDescriptionWhite, very deliquescent powder.The hydrate occurs as small, white, translucent crystals or granulesIdentification A. Positive tests for potassium and for carbonate B. Solubility Very soluble in water. Insoluble in ethanolPurityLoss on dryingNot more than 5 % (anhydrous) or 18 % (hydrate) (180 oC, 4h)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 501(ii) POTASSIUM HYDROGEN CARBONATE SynonymsPotassium bicarbonate, acid potassium carbonateDefinitionChemical namePotassium hydrogen carbonateEinecs206-059-0Chemical formulaKHCO3Molecular weight100,11AssayContent not less than 99,0 % and not more than 101,0 % KHCO3 on the anhydrous basisDescriptionColourless crystals or white powder or granulesIdentification A. Positive tests for potassium and for carbonate B. Solubility Freely soluble in water. Insoluble in ethanolPurityLoss on dryingNot more than 0,25 % (over silica gel, 4h)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 503(i) AMMONIUM CARBONATE DefinitionAmmonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportionsChemical nameAmmonium carbonateEinecs233-786-0Chemical formulaCH6N2O2, CH8N2O3 and CH5NO3Molecular weightAmmonium carbamate 78,06; ammonium carbonate 98,73; ammonium hydrogen carbonate 79,06AssayContent not less than 30,0 % and not more than 34,0 % of NH3DescriptionWhite powder or hard, white or translucent masses or crystals. Becomes opaque on exposure to air and is finally converted into white porous lumps or powder (of ammonium bicarbonate) due to loss of ammonia and carbon dioxideIdentification

A. Positive tests for ammonium and for carbonate B. pH of a 5 % solution about 8,6 C. Solubility Soluble in waterPurityNon-volatile matterNot more than 500 mg/kgChloridesNot more than 30 mg/kgSulphateNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 503(ii) AMMONIUM HYDROGEN CARBONATE SynonymsAmmonium bicarbonateDefinitionChemical nameAmmonium hydrogen carbonateEinecs213-911-5Chemical formulaCH5NO3Molecular weight79,06AssayContent not less than 99,0 %DescriptionWhite crystals or crystalline powderIdentification A. Positive tests for ammonium and for carbonate B. pH of a 5 % solution about 8,0 C. Solubility Freely soluble in water. Insoluble in ethanolPurityNon-volatile matterNot more than 500 mg/kgChloridesNot more than 30 mg/kgSulphateNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 504(ii) MAGNESIUM HYDROXIDE CARBONATE SynonymsMagnesium hydrogen carbonate, magnesium subcarbonate (light or heavy), hydrated basic magnesium carbonate, magnesium carbonate hydroxideDefinitionChemical nameMagnesium carbonate hydroxide hydratedEinecs235-192-7Chemical formula4MgCO3Mg(OH)25H2OMolecular weight485AssayMg content not less than 40,0 % and not more than 45,0 % calculated as MgODescriptionLight, white friable mass or bulky white powderIdentification A. Positive tests for magnesium and for carbonate B. Solubility Practically insoluble in water. Insoluble in ethanolPurityAcid insoluble matterNot more than 0,05 %Water soluble matterNot more than 1,0 %CalciumNot more than 1,0 %ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kg E 507 HYDROCHLORIC ACID SynonymsHydrogen chloride, muriatic acidDefinitionChemical nameHydrochloric acidEinecs231-595-7Chemical formulaHClMolecular weight36,46AssayHydrochloric acid is commercially available in varying concentrations. Concentrated hydrochloric acid contains not less than 35,0 % HClDescriptionClear, colourless or slightly yellowish, corrosive liquid having a pungent odourIdentification A. Positive tests for acid and for chloride B. Solubility Soluble in water and in ethanolPurityTotal organic compoundsTotal organic compounds (non-fluorine containing): not more than 5 mg/kgBenzene: not more than 0,05 mg/kgFluorinated compounds (total): not more than 25 mg/kgNon-volatile matterNot more than 0,5 %Reducing substancesNot more than 70 mg/kg (as SO2)Oxidising substancesNot more than 30 mg/kg (as Cl2)SulphateNot more than 0,5 %IronNot more than 5 mg/kgArsenicNot more than 1 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 1 mg/kg E 508 POTASSIUM CHLORIDE SynonymsSylvineSylviteDefinitionChemical namePotassium chlorideEinecs231-211-8Chemical formulaeKClMolecular weight74,56AssayContent not less than 99 % on the dried basisDescriptionColourless, elongated, prismatic or cubital crystals or white granular powder. OdourlessIdentification A. Solubility Freely soluble in water. Insoluble in ethanol

B. Positive tests for potassium and for chloride PurityLoss on dryingNot more than 1 % (105 oC, 2 hours)SodiumNegative testArsenicNot more than 3 mg/kg LeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kg E 509 CALCIUM CHLORIDE DefinitionChemical nameCalcium chlorideEinecs233-140-8Chemical formulaCaCl2 · nH2O (n = 0,2 or 6)Molecular weight110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate)AssayContent not less than 93,0 % on the anhydrous basisDescriptionWhite, odourless, hygroscopic powder or deliquescent crystalsIdentification A. Positive tests for calcium and for chloride B. Solubility Anhydrous calcium chloride: freely soluble in water and ethanolDihydrate: freely soluble in water, soluble in ethanolHexahydrate: very soluble in water and ethanolPurityMagnesium and alkali saltsNot more than 5 % on the anhydrous basisFluorideNot more than 40 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kg E 511 MAGNESIUM CHLORIDE DefinitionChemical nameMagnesium chlorideEinecs232-094-6Chemical formulaMgCl2 · 6H2OMolecular weight203,30AssayContent not less than 99,0 %DescriptionColourless, odourless, very deliquescent flakes or crystalsIdentification A. Positive tests for magnesium and for chloride B. Solubility Very soluble in water, freely soluble in ethanolPurityAmmoniumNot more than 50 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kg E 512 STANNOUS CHLORIDE SynonymsTin chloride, tin dichlorideDefinitionChemical nameStannous chloride dihydrateEinecs231-868-0Chemical formulaSnCl2 · 2H2OMolecular weight225,63AssayContent not less than 98,0 %DescriptionColourless or white crystalsMay have a slight odour of hydrochloric acidIdentification A. Positive tests for tin (II) and for chloride B. Solubility Water: soluble in less than its own weight of water, but it forms an insoluble basic salt with excess waterEthanol: solublePuritySulphateNot more than 30 mg/kgArsenicNot more than 2 mg/kgMercuryNot more than 1 mg/kgLeadNot more than 5 mg/kg E 513 SULPHURIC ACID SynonymsOil of vitriol, dihydrogen sulphateDefinitionChemical nameSulphuric acidEinecs231-639-5Chemical formulaH2SO4Molecular weight98,07AssaySulphuric acid is commercially available in varying concentrations. The concentrated form contains not less than 96,0 %DescriptionClear, colourless or slightly brown, very corrosive oily liquidIdentification A. Positive tests for acid and for sulphate B. Solubility Miscible with water, with generation of much heat, also with ethanolPurityAshNot more than 0,02 %Reducing matterNot more than 40 mg/kg (as SO2)NitrateNot more than 10 mg/kg (on H2SO4 basis)ChlorideNot more than 50 mg/kgIronNot more than 20 mg/kgSeleniumNot more than 20 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 514(i) SODIUM SULPHATE DefinitionChemical nameSodium sulphateChemical formulaNa2SO4 · nH2O (n = 0 or 10)Molecular weight142,04 (anhydrous)322,04 (decahydrate)AssayContent not less than 99,0 % on the anhydrous basisDescriptionColourless crystals or a fine, white, crystalline powderThe decahydrate is efflorescentIdentification

A. Positive tests for sodium and for sulphate B. Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper PurityLoss on dryingNot more than 1,0 % (anhydrous) or not more than 57 % (decahydrate) at 130 °CSeleniumNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 514(ii) SODIUM HYDROGEN SULPHATE SynonymsAcid sodium sulphate, sodium bisulphate, nitre cakeDefinitionChemical nameSodium hydrogen sulphateChemical formulaNaHSO4Molecular weight120,06AssayContent not less than 95,2 %DescriptionWhite, odourless crystals or granulesIdentification A. Positive tests for sodium and for sulphate B. Solutions are strongly acidic PurityLoss on dryingNot more than 0,8 %Water insolubleNot more than 0,05 %SeleniumNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 515(i) POTASSIUM SULPHATE DefinitionChemical namePotassium sulphateChemical formulaK2SO4Molecular weight174,25AssayContent not less than 99,0 %DescriptionColourless or white crystals or crystalline powderIdentification A. Positive tests for potassium and for sulphate B. pH of a 5 % solution Between 5,5 and 8,5 C. Solubility Freely soluble in water, insoluble in ethanolPuritySeleniumNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 515(ii) POTASSIUM HYDROGEN SULPHATE DefinitionSynonymsPotassium bisulphate, potassium acid sulphateChemical namePotassium hydrogen sulphateChemical formulaKHSO4Molecular weight136,17AssayContent not less than 99 %Melting point197 oCDescriptionWhite deliquescent crystals, pieces or granulesIdentification A. Positive test for potassium B. Solubility Freely soluble in water, insoluble in ethanolPuritySeleniumNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 516 CALCIUM SULPHATE SynonymsGypsum, selenite, anhydriteDefinitionChemical nameCalcium sulphateEinecs231-900-3Chemical formulaCaSO4 · nH2O (n = 0 or 2)Molecular weight136,14 (anhydrous), 172,18 (dihydrate)AssayContent not less than 99,0 % on the anhydrous basis DescriptionFine, white to slightly yellowish-white odourless powderIdentification A. Positive tests for calcium and for sulphate B. Solubility Slightly soluble in water, insoluble in ethanolPurityLoss on dryingAnhydrous: not more than 1,5 % (250 oC, constant weight)Dihydrate: not more than 23 % (ibid.)FluorideNot more than 30 mg/kgSeleniumNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 517 AMMONIUM SULPHATE DefinitionChemical nameAmmonium sulphateEinecs231-984-1Chemical formula(NH4)2SO4Molecular weight132,14AssayContent not less than 99,0 % and not more than 100,5 %DescriptionWhite powder, shining plates or crystalline fragmentsIdentification A. Positive tests for ammonium and for sulphate B. Solubility Freely soluble in water, insoluble in ethanolPurityLoss on ignitionNot more than 0,25 %SeleniumNot more than 30 mg/kgLeadNot more than 5 mg/kg

E 520 ALUMINIUM SULPHATE SynonymsAlumDefinitionChemical nameAluminium sulphateEinecs233-135-0Chemical formulaAl2(SO4)3Molecular weight342,13AssayContent not less than 99,5 % on the ignited basisDescriptionWhite powder, shining plates or crystalline fragmentsIdentification A. Positive tests for aluminium and for sulphate B. pH of a 5 % solution 2,9 or above C. Solubility Freely soluble in water, insoluble in ethanol PurityLoss on ignitionNot more than 5 % (500 oC, 3h)Alkalies and alkaline earthsNot more than 0,4 %SeleniumNot more than 30 mg/kgFluorideNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kg E 521 ALUMINIUM SODIUM SULPHATE SynonymsSoda alum, sodium alumDefinitionChemical nameAluminium sodium sulphateEinecs233-277-3Chemical formulaAlNa(SO4)2 · nH2O (n = 0 or 12)Molecular weight242,09 (anhydrous)AssayContent on the anhydrous basis not less than 96,5 % (anhydrous) and 99,5 % (dodecahydrate)DescriptionTransparent crystals or white crystalline powderIdentification A. Positive tests for aluminium, for sodium and for sulphate B. Solubility Dodecahydrate is freely soluble in water. The anhydrous form is slowly soluble in water. Both forms are insoluble in ethanolPurityLoss on dryingAnhydrous form: not more than 10,0 % (220 oC, 16h)Dodecahydrate: not more than 47,2 % (50 oC-55 oC, 1h then 200 oC, 16h)Ammonium saltsNo odour of ammonia detectable after heatingSeleniumNot more than 30 mg/kgFluorideNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 522 ALUMINIUM POTASSIUM SULPHATE SynonymsPotassium alum, potash alumDefinitionChemical nameAluminium potassium sulphate dodecahydrateEinecs233-141-3Chemical formulaAlK(SO4)2 · 12 H2OMolecular weight474,38AssayContent not less than 99,5 %DescriptionLarge, transparent crystals or white crystalline powderIdentification A. Positive tests for aluminium, for potassium and for sulphate B. pH of a 10 % solution between 3,0 and 4,0 C. Solubility Freely soluble in water, insoluble in ethanolPurityAmmonium saltsNo odour of ammonia detectable after heatingSeleniumNot more than 30 mg/kgFluorideNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 523 ALUMINIUM AMMONIUM SULPHATE SynonymsAmmonium alumDefinitionChemical nameAluminium ammonium sulphateEinecs232-055-3Chemical formulaAlNH4(SO4)2 · 12 H2OMolecular weight453,32AssayContent not less than 99,5 %DescriptionLarge, colourless crystals or white powderIdentification A. Positive tests for aluminium, for ammonium and for sulphate B. Solubility Freely soluble in water, soluble in ethanolPurityAlkali metals and alkaline earthsNot more than 0,5 %SeleniumNot more than 30 mg/kgFluorideNot more than 30 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 524 SODIUM HYDROXIDE SynonymsCaustic soda, lyeDefinitionChemical nameSodium hydroxideEinecs215-185-5Chemical formulaNaOHMolecular weight40,0AssayContent of solid forms not less than 98,0 % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOHDescriptionWhite or nearly white pellets, flakes, sticks, fused masses or other forms. Solutions are clear or slightly turbid, colourless or slightly coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate

Identification A. Positive tests for sodium B. A 1 % solution is strongly alkaline C. Solubility Very soluble in water. Freely soluble in ethanolPurityWater insoluble and organic matterA 5 % solution is completely clear and colourless to slightly colouredCarbonateNot more than 0,5 % (as Na2CO3)ArsenicNot more than 3 mg/kgLeadNot more than 0,5 mg/kgMercuryNot more than 1 mg/kg E 525 POTASSIUM HYDROXIDE SynonymsCaustic potashDefinitionChemical namePotassium hydroxideEinecs215-181-3Chemical formulaKOHMolecular weight56,11AssayContent not less than 85,0 % of alkali calculated as KOHDescriptionWhite or nearly white pellets, flakes, sticks, fused masses or other formsIdentification A. Positive tests for potassium B. A 1 % solution is strongly alkaline C. Solubility Very soluble in water. Freely soluble in ethanolPurityWater insoluble matterA 5 % solution is completely clear and colourlessCarbonateNot more than 3,5 % (as K2CO3)ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kg E 526 CALCIUM HYDROXIDE SynonymsSlaked lime, hydrated limeDefinitionChemical nameCalcium hydroxideEinecs215-137-3Chemical formulaCa(OH)2Molecular weight74,09AssayContent not less than 92,0 % DescriptionWhite powderIdentification A. Positive tests for alkali and for calcium B. Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerolPurityAcid insoluble ashNot more than 1,0 %Magnesium and alkali saltsNot more than 1,0 %BariumNot more than 300 mg/kgFluorideNot more than 50 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kg E 527 AMMONIUM HYDROXIDE SynonymsAqua ammonia, strong ammonia solutionDefinitionChemical nameAmmonium hydroxideChemical formulaNH4OHMolecular weight35,05AssayContent not less than 27 % of NH3DescriptionClear, colourless solution, having an exceedingly pungent, characteristic odourIdentification A. Positive tests for ammonia PurityNon-volatile matterNot more than 0,02 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kg E 528 MAGNESIUM HYDROXIDE DefinitionChemical nameMagnesium hydroxideEinecs215-170-3Chemical formulaMg(OH)2Molecular weight58,32AssayContent not less than 95,0 % on the anhydrous basisDescriptionOdourless, white bulky powderIdentification A. Positive test for magnesium and for alkali B. Solubility Practically insoluble in water and in ethanol PurityLoss on dryingNot more than 2,0 % (105 oC, 2h)Loss on ignitionNot more than 33 % (800 oC to constant weight)Calcium oxideNot more than 1,5 %ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kg E 529 CALCIUM OXIDE SynonymsBurnt limeDefinitionChemical nameCalcium oxideEinecs215-138-9Chemical formulaCaOMolecular weight56,08AssayContent not less than 95,0 % on the ignited basisDescriptionOdourless, hard, white or greyish white masses of granules, or white to greyish powderIdentification A. Positive test for alkali and for calcium B. Heat is generated on moistening the sample with water C. Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerolPurityLoss on ignitionNot more than 10,0 % (ca 800 oC to constant weight)Acid insoluble matterNot more than 1,0 %BariumNot more than 300 mg/kgMagnesium and alkali saltsNot more than 1,5 %FluorideNot more than 50 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kg

E 530 MAGNESIUM OXIDE DefinitionChemical nameMagnesium oxideEinecs215-171-9Chemical formulaMgOMolecular weight40,31AssayContent not less than 98,0 % on the ignited basisDescriptionA very bulky, white powder known as light magnesium oxide or a relative dense, white powder known as heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of 40 to 50 ml, while 5 g of heavy magnesium oxide occupy a volume of 10 to 20 mlIdentification A. Positive test for alkali and for magnesium B. Solubility Practically insoluble in water. Insoluble in ethanol PurityLoss on ignitionNot more than 5,0 % (ca 800 oC to constant weight)Calcium oxideNot more than 1,5 %ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kg E 535 SODIUM FERROCYANIDE SynonymsYellow prussiate of soda, sodium hexacyanoferrateDefinitionChemical nameSodium ferrocyanideEinecs237-081-9Chemical formulaNa4Fe(CN)6 · 10 H2OMolecular weight484,1AssayContent not less than 99,0 %DescriptionYellow crystals or crystalline powderIdentification A. Positive test for sodium and for ferrocyanide PurityFree moistureNot more than 1,0 %Water insoluble matterNot more than 0,03 %ChlorideNot more than 0,2 %SulphateNot more than 0,1 %Free cyanideNot detectableFerricyanideNot detectableLeadNot more than 5 mg/kg E 536 POTASSIUM FERROCYANIDE SynonymsYellow prussiate of potash, potassium hexacyanoferrateDefinitionChemical namePotassium ferrocyanideEinecs237-722-2Chemical formulaK4Fe(CN)6· 3 H2OMolecular weight422,4AssayContent not less than 99,0 %DescriptionLemon yellow crystalsIdentification A. Positive test for potassium and for ferrocyanide PurityFree moistureNot more than 1,0 %Water insoluble matterNot more than 0,03 %ChlorideNot more than 0,2 %SulphateNot more than 0,1 %Free cyanideNot detectable FerricyanideNot detectableLeadNot more than 5 mg/kg E 538 CALCIUM FERROCYANIDE SynonymsYellow prussiate of lime, calcium hexacyanoferrateDefinitionChemical nameCalcium ferrocyanideEinecs215-476-7Chemical formulaCa2Fe(CN)6 · 12H2OMolecular weight508,3AssayContent not less than 99,0 %DescriptionYellow crystals or crystalline powderIdentification A. Positive test for calcium and for ferrocyanide PurityFree moistureNot more than 1,0 %Water insoluble matterNot more than 0,03 %ChlorideNot more than 0,2 %SulphateNot more than 0,1 %Free cyanideNot detectableFerricyanideNot detectableLeadNot more than 5 mg/kg E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC SynonymsSALPDefinitionChemical nameSodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A) orTrisodium dialuminium pentadecahydrogen octaphosphate (B)Einecs232-090-4Chemical formulaNaAl3H14(PO4)8 · 4H2O (A)Na3Al2H15(PO4)8 (B)Molecular weight949,88 (A)897,82 (B)AssayContent not less than 95,0 % (both forms)DescriptionWhite odourless powderIdentification A. Positive test for sodium, for aluminium and for phosphate B. pH Acid to litmus C. Solubility Insoluble in water. Soluble in hydrochloric acidPurityLoss on ignition19,5 %-21,0 % (A) } (750 oC-800 oC, 2h)15 %-16 % (B) } (750 oC-800 oC, 2h)FluorideNot more than 25 mg/kg

ArsenicNot more than 3 mg/kgLeadNot more than 4 mg/kgCadmiumNot more than 1 mg/kgMercuryNot more than 1 mg/kg E 551 SILICON DIOXIDE SynonymsSilica, silicium dioxideDefinitionSilicon dioxide is an amorphous substance, which is produced synthetically by either a vapour-phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. Fumed silica is produced in essentially an anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed waterChemical nameSilicon dioxideEinecs231-545-4Chemical formula(SiO2)nMolecular weight60,08 (SiO2)AssayContent after ignition not less than 99,0 % (fumed silica) or 94,0 % (hydrated forms)DescriptionWhite, fluffy powder or granulesHygroscopicIdentification A. Positive test for silica PurityLoss on dryingNot more than 2,5 % (fumed silica, 105 oC, 2h)Not more than 8,0 % (precipitated silica and silica gel, 105 oC, 2h)Not more than 70 % (hydrous silica, 105 oC, 2h)Loss on ignitionNot more than 2,5 % after drying (1000 oC, fumed silica)Not more than 8,5 % after drying (1000 oC, hydrated forms)Soluble ionisable saltsNot more than 5,0 % (as Na2SO4)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 552 CALCIUM SILICATE DefinitionCalcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO2Chemical nameCalcium silicateEinecs215-710-8Assay Content on the anhydrous basis: as SiO2 not less than 50 % and not more than 95 % as CaO not less than 3 % and not more than 35 % DescriptionWhite to off-white free-flowing powder that remains so after absorbing relatively large amounts of water or other liquids Identification A. Positive test for silicate and for calcium B. Forms a gel with mineral acids PurityLoss on dryingNot more than 10 % (105 oC, 2h)Loss on ignitionNot less than 5 % and not more than 14 % (1000 oC, constant weight)SodiumNot more than 3 %FluorideNot more than 50 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 553a(i) MAGNESIUM SILICATE DefinitionMagnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5AssayContent not less than 15 % of MgO and not less than 67 % of SiO2 on the ignited basisDescriptionVery fine, white, odourless powder, free from grittinessIdentification A. Positive test for magnesium and for silicate B. pH of a 10 % slurry Between 7,0 and 10,8PurityLoss on dryingNot more than 15 % (105 oC, 2h)Loss on ignitionNot more than 15 % after drying (1000 oC, 20 min)Water soluble saltsNot more than 3 %Free alkaliNot more than 1 % (as NaOH)FluorideNot more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 553a(ii) MAGNESIUM TRISILICATE DefinitionChemical nameMagnesium trisilicateChemical formulaMg2Si3O8 · xH2O (approximate composition)Einecs239-076-7AssayContent not less than 29,0 % of MgO and not less than 65,0 % of SiO2 both on the ignited basisDescriptionFine, white powder, free from grittinessIdentification

A. Positive test for magnesium and for silicate B. pH of a 5 % slurry Between 6,3 and 9,5 PurityLoss on ignitionNot less than 17 % and not more than 34 % (1000 oC)Water soluble saltsNot more than 2 %Free alkaliNot more than 1 % (as NaOH)FluorideNot more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 553b TALC SynonymsTalcumDefinitionNaturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha-quartz, calcite, chlorite, dolomite, magnesite, and phlogopiteChemical nameMagnesium hydrogen metasilicateEinecs238-877-9Chemical formulaMg3(Si4O10)(OH)2Molecular weight379,22DescriptionLight, homogeneous, white or almost white powder, greasy to the touchIdentification A. IR absorption Characteristic peaks at 3677, 1018 and 669 cm-1 B. X-ray diffraction Peaks at 9,34/4,66/3,12 Å C. Solubility Insoluble in water and ethanolPurityLoss on dryingNot more than 0,5 % (105 oC, 1h)Acid-soluble matterNot more than 6 %Water-soluble matterNot more than 0,2 %Acid-soluble ironNot detectableArsenicNot more than 10 mg/kgLeadNot more than 5 mg/kg E 554 SODIUM ALUMINIUM SILICATE SynonymsSodium silicoaluminate, sodium aluminosilicate, aluminium sodium silicateDefinitionChemical nameSodium aluminium silicateAssay Content on the anhydrous basis: as SiO2 not less than 66,0 % and not more than 88,0 % as Al2O3 not less than 5,0 % and not more than 15,0 % DescriptionFine white amorphous powder or beadsIdentification A. Positive tests for sodium, for aluminium and for silicate B. pH of a 5 % slurry Between 6,5 and 11,5 PurityLoss on dryingNot more than 8,0 % (105 oC, 2h)Loss on ignitionNot less than 5,0 % and not more than 11,0 % on the anhydrous basis (1000 oC, constant weight)SodiumNot less than 5 % and not more than 8,5 % (as Na2O) on the anhydrous basisArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 555 POTASSIUM ALUMINIUM SILICATE SynonymsMicaDefinitionNatural mica consists of mainly potassium aluminium silicate (muscovite)Einecs310-127-6Chemical namePotassium aluminium silicateChemical formulaeKAl2AlSi3O102Molecular weight398AssayContent not less than 98 %DescriptionLight grey to white crystalline platelets or powderIdentification A. Solubility Insoluble in water, diluted acids and alkali and organic solventsPurityLoss on dryingNot more than 0,5 % (105 oC, 2h)AntimonyNot more than 20 mg/kgZincNot more than 25 mg/kgBariumNot more than 25 mg/kgChromiumNot more than 100 mg/kgCopperNot more than 25 mg/kgNickelNot more than 50 mg/kgArsenicNot more than 3 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 2 mg/kgLeadNot more than 10 mg/kg E 556 CALCIUM ALUMINIUM SILICATE SynonymsCalcium aluminosilicate, calcium silicoaluminate, aluminium calcium silicateDefinitionChemical nameCalcium aluminium silicateAssay Content on the anhydrous basis: as SiO2 not less than 44,0 % and not more than 50,0 % as Al2O3 not less than 3,0 % and not more than 5,0 %

as CaO not less than 32,0 % and not more than 38,0 % DescriptionFine white, free-flowing powderIdentification A. Positive tests for calcium, for aluminium and for silicate PurityLoss on dryingNot more than 10,0 % (105 oC, 2h)Loss on ignitionNot less than 14,0 % and not more than 18,0 on the anhydrous basis (1000 oC, constant weight)FluorideNot more than 50 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kg E 558 BENTONITE DefinitionBentonite is a natural clay containing a high proportion of montmorillonite, a native hydrated aluminium silicate in which some aluminium and silicon atoms were naturally replaced by other atoms such as magnesium and iron. Calcium and sodium ions are trapped between the mineral layers. There are four common types of bentonite: natural sodium bentonite, natural calcium bentonite, sodium-activated bentonite and acid-activated bentoniteEinecs215-108-5Chemical formula(Al, Mg)8(Si4O10) 4(OH)8 · 12H2OMolecular weight819AssayMontmorillonite content not less than 80 %DescriptionVery fine, yellowish or greyish white powder or granules. The structure of bentonite allows it to absorb water in its structure and on its external surface (swelling properties)Identification A. Methylene blue test B. X-Ray diffraction Characteristic peaks at 12,5/15 A C. IR absorption Peaks at 428/470/530/1110-1020/3750 — 3400 cm-1PurityLoss on dryingNot more than 15,0 % (105 oC, 2h)ArsenicNot more than 2 mg/kgLeadNot more than 20 mg/kg E 559 ALUMINIUM SILICATE (KAOLIN) SynonymsKaolin, light or heavyDefinitionAluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumptionEinecs215-286-4 (kaolinite)Chemical formulaAl2Si2O5(OH)4 (kaolinite)Molecular weight264 AssayContent not less than 90 % (sum of silica and alumina, after ignition)Silica (SiO2)Between 45 % and 55 %Alumina (Al2O3)Between 30 % and 39 %DescriptionFine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakesIdentification A. Positive tests for alumina and for silicate B. X-ray diffraction: Characteristic peaks at 7,18/3,58/2,38/1,78 Å C. IR absorption: Peaks at 3700 and 3620 cm-1PurityLoss on ignitionBetween 10 and 14 % (1000 oC, constant weight)Water soluble matterNot more than 0,3 %Acid soluble matterNot more than 2 %IronNot more than 5 %Potassium oxide (K2O)Not more than 5 %CarbonNot more than 0,5 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 570 FATTY ACIDS DefinitionLinear fatty acids, caprylic acid (C8), capric acid (C10), laurinc acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1)Chemical nameoctanoic acid (C8), decanoic acid (C10), dodecanoic acid (C12), tetradecanoic acid (C14), hexadecanoic acid (C16), octadecanoic acid (C18), 9-octadecenoic acid (C18:1)AssayNot less than 98 % by chromatographyDescriptionA colourless liquid or white solid obtained from oils and fatsIdentification

A. Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight PurityResidue on ignitionNot more than 0,1 %Unsaponifiable matterNot more than 1,5 %WaterNot more than 0,2 % (Karl Fischer method)ArsenicNot more than 3 mg/kgLeadNot more than 1 mg/kgMercuryNot more than 1 mg/kg E 574 GLUCONIC ACID SynonymsD-gluconic acid, dextronic acidDefinitionGluconic acid is an aqueous solution of gluconic acid and glucono-delta-lactoneChemical nameGluconic acid Chemical formulaC6H12O7 (gluconic acid)Molecular weight196,2AssayContent not less than 50,0 % (as gluconic acid)DescriptionColourless to light yellow, clear syrupy liquidIdentification A. Formation of phenylhydrazine derivative positive Compound formed melts between 196 oC and 202 oC with decompositionPurityResidue on ignitionNot more than 1,0 %Reducing matterNot more than 0,75 % (as D-glucose)ChlorideNot more than 350 mg/kgSulphateNot more than 240 mg/kgSulphiteNot more than 20 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 575 GLUCONO-DELTA-LACTONE SynonymsGluconolactone, GDL, D-gluconic acid delta-lactone, delta-gluconolactoneDefinitionGlucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 %-66 %) and the delta- and gamma-lactonesChemical nameD-Glucono-1,5-lactoneEinecs202-016-5Chemical formulaC6H10O6Molecular weight178,14AssayContent not less than 99,0 % on the anhydrous basisDescriptionFine, white, nearly odourless, crystalline powderIdentification A. Formation of phenylhydrazine derivative of gluconic acid positive Compound formed melts between 196 oC and 202 oC with decomposition B. Solubility Freely soluble in water. Sparingly soluble in ethanol C. Melting point 152 oC ± 2 oCPurityWaterNot more than 1,0 % (Karl Fischer method)Reducing substancesNot more than 0,75 % (as D-glucose)LeadNot more than 2 mg/kg E 576 SODIUM GLUCONATE SynonymsSodium salt of D-gluconic acidDefinitionChemical nameSodium D-gluconateEinecs208-407-7Chemical formulaC6H11NaO7 (anhydrous) Molecular weight218,14AssayContent not less than 98,0 %DescriptionWhite to tan, granular to fine, crystalline powderIdentification A. Positive test for sodium and for gluconate B. Solubility Very soluble in water. Sparingly soluble in ethanol C. pH of a 10 % solution Between 6,5 and 7,5PurityReducing matterNot more than 1,0 % (as D-glucose)LeadNot more than 2 mg/kg E 577 POTASSIUM GLUCONATE SynonymsPotassium salt of D-gluconic acidDefinitionChemical namePotassium D-gluconateEinecs206-074-2Chemical formulaC6H11KO7 (anhydrous)C6H11KO7 · H2O (monohydrate)Molecular weight234,25 (anhydrous)252,26 (monohydrate)AssayContent not less than 97,0 % and not more than 103,0 % on dried basisDescriptionOdourless, free flowing white to yellowish white, crystalline powder or granulesIdentification A. Positive test for potassium and for gluconate B. pH of a 10 % solution

Between 7,0 and 8,3PurityLoss on drying Anhydrous: not more than 3,0 % (105 oC, 4h, vacuum) Monohydrate: not less than 6 % and not more than 7,5 % (105 oC, 4h, vacuum) Reducing substancesNot more than 1,0 % (as D-glucose)LeadNot more than 2 mg/kg E 578 CALCIUM GLUCONATE SynonymsCalcium salt of D-gluconic acidDefinitionChemical nameCalcium di-D-gluconateEinecs206-075-8Chemical formulaC12H22CaO14 (anhydrous)C12H22CaO14 · H2O (monohydrate)Molecular weight430,38 (anhydrous form)448,39 (monohydrate) AssayContent not less than 98,0 % and not more than 102 % on the anhydrous and monohydrate basisDescriptionOdourless, white crystalline granules or powder, stable in airIdentification A. Positive test for calcium and for gluconate B. Solubility Soluble in water, insoluble in ethanol C. pH of a 5 % solution Between 6,0 and 8,0PurityLoss on dryingNot more than 3,0 % (105 oC, 16h) (anhydrous)Not more than 2,0 % (105 oC, 16h) (monohydrate)Reducing substancesNot more than 1,0 % (as D-glucose)LeadNot more than 2 mg/kg E 579 FERROUS GLUCONATE DefinitionChemical nameFerrous di-D-gluconate dihydrateIron(II) di-gluconate dihydrateEinecs206-076-3Chemical formulaeC12H22FeO14·2H2OMolecular weight482,17AssayContent not less than 95 % on the dried basisDescriptionPale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugarIdentification A. Solubility Soluble with slight heating in water. Practically insoluble in ethanol B. Positive test for ferrous ion C. Formation of phenylhy-drazine derivative of gluconic acid positive D. pH of a 10 % solution Between 4 and 5,5PurityLoss on dryingNot more than 10 % (105 oC, 16 hours)Oxalic acidNot detectableIron (Fe III)Not more than 2 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgReducing substancesNot more than 0,5 % expressed as glucose E 585 FERROUS LACTATE SynonymsIron(II) lactateIron(II) 2-hydroxy propanoatePropanoic acid, 2-hydroxy-iron(2 +) salt (2:1) DefinitionChemical nameFerrous 2-hydroxy propanoateEinecs227-608-0Chemical formulaeC6H10FeO6·xH2O (x = 2 or 3)Molecular weight270,02 (dihydrate)288,03 (trihydrate)AssayContent not less than 96 % on the dried basisDescriptionGreenish-white crystals or light green powder having a characteristic smellIdentification A. Solubility Soluble in water. Practically insoluble in ethanol B. Positive test for ferrous ion and for lactate C. pH of a 2 % solution Between 4 and 6PurityLoss on dryingNot more than 18 % (100 oC, under vacuum, approximately 700 mm Hg)Iron (Fe III)Not more than 0,6 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kg E 586 4-HEXYLRESORCINOL Synonyms4-Hexyl-1,3-benzenediolHexylresorcinolDefinitionChemical name4-HexylresorcinolEinecs205-257-4Chemical formulaC12H18O2Molecular weight197,24AssayNot less than 98 % on the dried basisDescriptionWhite powderIdentification A. Solubility Freely soluble in ether and acetone; very slightly soluble in water

B. Nitric acid test To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears C. Bromine test To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution D. Melting range 62 to 67 oCPurityAcidityNot more than 0,05 %Sulphated ashNot more than 0,1 %Resorcinol and other phenolsShake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is producedNickelNot more than 2 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 3 mg/kg E 620 GLUTAMIC ACID SynonymsL-Glutamic acid, L-α-aminoglutaric acidDefinitionChemical nameL-Glutamic acid, L-2-amino-pentanedioic acidEinecs200-293-7Chemical formulaC5H9NO4Molecular weight147,13AssayContent not less than 99,0 % and not more than 101,0 % on the anhydrous basisDescriptionWhite crystals or crystalline powderIdentification A. Positive test for glutamic acid by thin layer chromatography B. Specific rotation [α]D20 Between +31,5o and +32,2o(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) C. pH of a saturated solution Between 3,0 and 3,5PurityLoss on dryingNot more than 0,2 % (80 oC, 3h)Sulphated ashNot more than 0,2 %ChlorideNot more than 0,2 %Pyrrolidone carboxylic acidNot more than 0,2 %LeadNot more than 2 mg/kg E 621 MONOSODIUM GLUTAMATE SynonymsSodium glutamate, MSGDefinitionChemical nameMonosodium L-glutamate monohydrateEinecs205-538-1Chemical formulaC5H8NaNO4 · H2OMolecular weight187,13AssayContent not less than 99,0 % and not more than 101,0 % on the anhydrous basisDescriptionWhite, practically odourless crystals or crystalline powderIdentification A. Positive test for sodium B. Positive test for glutamic acid by thin-layer chromatography C. Specific rotation [α]D20 Between +24,8o and +25,3o(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) D. pH of a 5 % solution Between 6,7 and 7,2PurityLoss on dryingNot more than 0,5 % (98 oC, 5h)ChlorideNot more than 0,2 %Pyrrolidone carboxylic acidNot more than 0,2 %LeadNot more than 2 mg/kg E 622 MONOPOTASSIUM GLUTAMATE SynonymsPotassium glutamate, MPGDefinitionChemical nameMonopotassium L-glutamate monohydrateEinecs243-094-0Chemical formulaC5H8KNO4 · H2OMolecular weight203,24AssayContent not less than 99,0 % and not more than 101,0 % on the anhydrous basisDescriptionWhite, practically odourless crystals or crystalline powderIdentification A. Positive test for potassium B. Positive test for glutamic acid by thin-layer chromatog-raphy C. Specific rotation [α]D20 Between +22,5o and +24,0o(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) D. pH of a 2 % solution Between 6,7 and 7,3PurityLoss on dryingNot more than 0,2 % (80 oC, 5h)ChlorideNot more than 0,2 %Pyrrolidone carboxylic acidNot more than 0,2 %LeadNot more than 2 mg/kg E 623 CALCIUM DIGLUTAMATE SynonymsCalcium glutamateDefinitionChemical nameMonocalcium di-L-glutamateEinecs242-905-5Chemical formulaC10H16CaN2O8 · x H2O (x = 0, 1, 2 or 4)Molecular weight332,32 (anhydrous)AssayContent not less than 98,0 % and not more than 102,0 % on the anhydrous basisDescriptionWhite, practically odourless crystals or crystalline powderIdentification

A. Positive test for calcium B. Positive test for glutamic acid by thin-layer chromatog-raphy C. Specific rotation [α]D20 Between +27,4 and +29,2 (for calcium diglutamate with x = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)PurityWaterNot more than 19,0 % (for calcium diglutamate with x = 4) (Karl Fischer)ChlorideNot more than 0,2 %Pyrrolidone carboxylic acidNot more than 0,2 %LeadNot more than 2 mg/kg E 624 MONOAMMONIUM GLUTAMATE SynonymsAmmonium glutamateDefinitionChemical nameMonoammonium L-glutamate monohydrateEinecs231-447-1Chemical formulaC5H12N2O4 · H2OMolecular weight182,18AssayContent not less than 99,0 % and not more 101,0 % on the anhydrous basisDescriptionWhite, practically odourless crystals or crystalline powderIdentification A. Positive test for ammonium B. Positive test for glutamic acid by thin-layer chromatog-raphy C. Specific rotation [α]D20 Between +25,4o and +26,4o(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) D. pH of a 5 % solution Between 6,0 and 7,0PurityLoss on dryingNot more than 0,5 % (50 oC, 4h)Sulphated ashNot more than 0,1 %Pyrrolidone carboxylic acidNot more than 0,2 %LeadNot more than 2 mg/kg E 625 MAGNESIUM DIGLUTAMATE SynonymsMagnesium glutamateDefinitionChemical nameMonomagnesium di-L-glutamate tetrahydrateEinecs242-413-0Chemical formulaC10H16MgN2O8 · 4H2OMolecular weight388,62AssayContent not less than 95,0 % and not more than 105,0 % on the anhydrous basisDescriptionOdourless, white or off-white crystals or powderIdentification A. Positive test for magnesium B. Positive test for glutamic acid by thin-layer chromatog-raphy C. Specific rotation [α]D20 Between +23,8o and +24,4o(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) D. pH of a 10 % solution Between 6,4 and 7,5PurityWaterNot more than 24 % (Karl Fischer)ChlorideNot more than 0,2 %Pyrrolidone carboxylic acidNot more than 0,2 %LeadNot more than 2 mg/kg E 626 GUANYLIC ACID SynonymsGuanylic acidDefinitionChemical nameGuanosine-5'-monophosphoric acidEinecs201-598-8Chemical formulaC10H14N5O8PMolecular weight363,22AssayContent not less than 97,0 % on the anhydrous basisDescriptionOdourless, colourless or white crystals or white crystalline powderIdentification A. Positive test for ribose and for organic phosphate B. pH of a 0,25 % solution Between 1,5 and 2,5 C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nmPurityLoss on dryingNot more than 1,5 % (120 oC, 4h)Other nucleotidesNot detectable by thin-layer chromatographyLeadNot more than 2 mg/kg E 627 DISODIUM GUANYLATE SynonymsSodium guanylate, sodium 5'-guanylateDefinitionChemical nameDisodium guanosine-5'-monophosphateEinecs221-849-5Chemical formulaC10H12N5Na2O8P· x H2O (x = ca. 7)Molecular weight407,19 (anhydrous)AssayContent not less than 97,0 % on the anhydrous basisDescriptionOdourless, colourless or white crystals or white crystalline powderIdentification A. Positive test for ribose, for organic phosphate, and for sodium B. pH of a 5 % solution

Between 7,0 and 8,5 C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nmPurityLoss on dryingNot more than 25 % (120 oC, 4h)Other nucleotidesNot detectable by thin-layer chromatographyLeadNot more than 2 mg/kg E 628 DIPOTASSIUM GUANYLATE SynonymsPotassium guanylate, potassium 5'-guanylateDefinitionChemical nameDipotassium guanosine-5'-monophosphateEinecs226-914-1 Chemical formulaC10H12K2N5O8PMolecular weight439,40AssayContent not less than 97,0 % on the anhydrous basisDescriptionOdourless, colourless or white crystals or white crystalline powderIdentification A. Positive test for ribose, for organic phosphate, and for potassium B. pH of a 5 % solution Between 7,0 and 8,5 C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nmPurityLoss on dryingNot more than 5 % (120 oC, 4h)Other nucleotidesNot detectable by thin-layer chromatographyLeadNot more than 2 mg/kg E 629 CALCIUM GUANYLATE SynonymsCalcium 5'-guanylateDefinitionChemical nameCalcium guanosine-5'-monophosphateChemical formulaC10H12CaN5O8P· nH2OMolecular weight401,20 (anhydrous)AssayContent not less than 97,0 % on the anhydrous basisDescriptionOdourless, white or off-white crystals or powderIdentification A. Positive test for ribose, for organic phosphate, and for calcium B. pH of a 0,05 % solution Between 7,0 and 8,0 C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nmPurityLoss on dryingNot more than 23,0 % (120 oC, 4h)Other nucleotidesNot detectable by thin-layer chromatographyLeadNot more than 2 mg/kg E 630 INOSINIC ACID Synonyms5'-Inosinic acidDefinitionChemical nameInosine-5'-monophosphoric acidEinecs205-045-1Chemical formulaC10H13N4O8PMolecular weight348,21AssayContent not less than 97,0 % on the anhydrous basisDescriptionOdourless, colourless or white crystals or powder Identification A. Positive test for ribose, and for organic phosphate B. pH of a 5 % solution Between 1,0 and 2,0 C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nmPurityLoss on dryingNot more than 3,0 % (120 oC, 4h)Other nucleotidesNot detectable by thin-layer chromatographyLeadNot more than 2 mg/kg E 631 DISODIUM INOSINATE SynonymsSodium inosinate, sodium 5'-inosinateDefinitionChemical nameDisodium inosine-5'-monophosphateEinecs225-146-4Chemical formulaC10H11N4Na2O8P· H2OMolecular weight392,17 (anhydrous)AssayContent not less than 97,0 % on the anhydrous basisDescriptionOdourless, colourless or white crystals or powderIdentification A. Positive test for ribose, and for organic phosphate and for sodium B. pH of a 5 % solution Between 7,0 and 8,5 C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nmPurityWaterNot more than 28,5 % (Karl Fischer)Other nucleotidesNot detectable by thin-layer chromatographyLeadNot more than 2 mg/kg E 632 DIPOTASSIUM INOSINATE SynonymsPotassium inosinate, potassium 5'-inosinateDefinitionChemical nameDipotassium inosine-5'-monophosphateEinecs243-652-3Chemical formulaC10H11K2N4O8PMolecular weight424,39AssayContent not less than 97,0 % on the anhydrous basisDescriptionOdourless, colourless or white crystals or powderIdentification

A. Positive test for ribose, and for organic phosphate and for potassium B. pH of a 5 % solution Between 7,0 and 8,5 C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm PurityWaterNot more than 10,0 % (Karl Fischer)Other nucleotidesNot detectable by thin-layer chromatographyLeadNot more than 2 mg/kg E 633 CALCIUM INOSINATE SynonymsCalcium 5'-inosinateDefinitionChemical nameCalcium inosine-5'-monophosphateChemical formulaC10H11CaN4O8P· nH2OMolecular weight386,19 (anhydrous)AssayContent not less than 97,0 % on the anhydrous basisDescriptionOdourless, colourless or white crystals or powderIdentification A. Positive test for ribose, and for organic phosphate and for calcium B. pH of a 0,05 % solution Between 7,0 and 8,0 C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nmPurityWaterNot more than 23,0 % (Karl Fischer)Other nucleotidesNot detectable by thin-layer chromatographyLeadNot more than 2 mg/kg E 634 CALCIUM 5'-RIBONUCLEOTIDE DefinitionChemical nameCalcium 5'-ribonucleotide is essentially a mixture of calcium inosine-5'-monophosphate and calcium guanosine-5'-monophosphateChemical formulaC10H11N4CaO8P· nH2O yC10H12N5CaO8P· nH2OAssayContent of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basisDescriptionOdourless, white or nearly white crystals or powderIdentification A. Positive test for ribose, and for organic phosphate and for calcium B. pH of a 0,05 % solution Between 7,0 and 8,0PurityWaterNot more than 23,0 % (Karl Fischer)Other nucleotidesNot detectable by thin-layer chromatographyLeadNot more than 2 mg/kg E 635 DISODIUM 5'-RIBONUCLEOTIDE SynonymsSodium 5'-ribonucleotideDefinitionChemical nameDisodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphateChemical formulaC10H11N4Na2O8P · nH2O andC10H12N5Na2O8P· nH2OAssayContent of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basisDescriptionOdourless, white or nearly white crystals or powderIdentification A. Positive test for ribose, and for organic phosphate and for sodium B. pH of a 5 % solution Between 7,0 and 8,5PurityWaterNot more than 26,0 % (Karl Fischer)Other nucleotidesNot detectable by thin-layer chromatographyLeadNot more than 2 mg/kg E 640 GLYCINE AND ITS SODIUM SALT Synonyms(gly)Aminoacetic acid, glycocoll(Na salt)Sodium glycinateDefinitionChemical name (gly)Aminoacetic acid(Na salt)Sodium glycinateChemical formula (gly)C2H5NO2(Na salt)C2H5NO2 NaEinecs (gly)200-272-2(Na salt)227-842-3Molecular weight (gly)75,07(Na salt)98AssayContent not less than 98,5 % on the anhydrous basisDescriptionWhite crystals or crystalline powderIdentification A. Positive test for amino acid (gly and Na salt) B. Positive test for sodium (Na salt) PurityLoss on drying (gly)Not more than 0,2 % (105 oC, 3h)(Na salt)Not more than 0,2 % (105 oC, 3h)Residue on ignition (gly)Not more than 0,1 %(Na salt)Not more than 0,1 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg

E 650 ZINC ACETATE SynonymsAcetic acid, zinc salt, dihydrateDefinitionChemical nameZinc acetate dihydrateChemical formulaC4H6O4 Zn· 2H2OMolecular weight219,51AssayContent not less than 98 % and not more than 102 % of C4H6O4 Zn · 2H2ODescriptionColourless crystals or fine, off-white powderIdentification A. Positive tests for acetate and for zinc B. pH of a 5 % solution Between 6,0 and 8,0PurityInsoluble matterNot more than 0,005 %ChloridesNot more than 50 mg/kgSulphatesNot more than 100 mg/kgAlkalines and alkaline earthsNot more than 0,2 %Organic volatile impuritiesPasses testIronNot more than 50 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 20 mg/kgCadmiumNot more than 5 mg/kg E 900 DIMETHYL POLYSILOXANE SynonymsPolydimethyl siloxane, silicone fluid, silicone oil, dimethyl siliconeDefinitionDimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of the formula (CH3)2 SiO and stablised with trimethylsiloxy end-blocking units of the formula (CH3)3 SiOChemical nameSiloxanes and silicones, di-methylChemical formula(CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3AssayContent of total silicon not less than 37,3 % and not more than 38,5 %DescriptionClear, colourless, viscous liquidIdentification A. Specific gravity (25o/25 oC) Between 0,964 and 0,977 B. Refractive index [n]D25 Between 1,400 and 1,405 C. Infrared spectrum characteristic of the compound PurityLoss on dryingNot more than 0,5 % (150 oC, 4h)ViscosityNot less than 1,00 · 10-4 m2s-1 at 25 oCArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 901 BEESWAX SynonymsWhite wax, yellow waxDefinitionYellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matterWhite beeswax is obtained by bleaching yellow beeswaxEinecs232-383-7 (beeswax)DescriptionYellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odourIdentification A. Melting range Between 62 oC and 65 oC B. Specific gravity About 0,96 C. Solubility Insoluble in waterSparingly soluble in alcoholVery soluble in chloroform and etherPurityAcid valueNot less than 17 and not more than 24Saponification value87-104Peroxide valueNot more than 5Glycerol and other polyolsNot more than 0,5 % (as glycerol)Ceresin, paraffins and certain other waxesAbsentFats, Japan wax, rosin and soapsAbsentArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 902 CANDELILLA WAX DefinitionCandelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphiliticaEinecs232-347-0DescriptionHard, yellowish brown, opaque to translucent waxIdentification A. Specific gravity About 0,983 B. Melting range Between 68,5 oC and 72,5 oC C. Solubility Insoluble in waterSoluble in chloroform and toluenePurityAcid valueNot less than 12 and not more than 22Saponification valueNot less than 43 and not more than 65Glycerol and other polyolsNot more than 0,5 % (as glycerol)Ceresin, paraffins and certain other waxesAbsentFats, Japan wax, rosin and soapsAbsentArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg

E 903 CARNAUBA WAX DefinitionCarnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm, Copernicia ceriferaEinecs232-399-4DescriptionLight brown to pale yellow powder or flakes or hard and brittle solid with a resinous fractureIdentification A. Specific gravity About 0,997 B. Melting range Between 82 oC and 86 oC C. Solubility Insoluble in waterPartly soluble in boiling ethanolSoluble in chloroform and diethyl etherPuritySulphated ashNot more than 0,25 %Acid valueNot less than 2 and not more than 7Ester valueNot less than 71 and not more than 88Unsaponifiable matterNot less than 50 % and not more than 55 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 904 SHELLAC SynonymsBleached shellac, white shellacDefinitionShellac is the purified and bleached lac, the resinous secretion of the insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae)Einecs232-549-9DescriptionBleached shellac — off-white, amorphous, granular resinWax-free bleached shellac — light yellow, amorphous, granular resinIdentification A. Solubility Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone B. Acid value Between 60 and 89PurityLoss on dryingNot more than 6,0 % (40 oC, over silica gel, 15h)RosinAbsentWaxBleached shellac: not more than 5,5 %Wax-free bleached shellac: not more than 0,2 %LeadNot more than 2 mg/kg E 905 MICROCRYSTALLINE WAX SynonymsPetroleum waxDefinitionMicrocrystalline wax is a refined mixture of solid, saturated hydrocarbons, mainly branched paraffin, obtained from petroleumDescriptionWhite to amber, odourless wax Identification A. Solubility Insoluble in water, very slightly soluble in ethanol B. Refractive Index n D1001,434-1,448PurityMolecular weightAverage not less than 500Viscosity at 100 oCNot less than 1,1 · 10-5 m2s-1Residue on ignitionNot more than 0,1 %Carbon number at 5 % distillation pointNot more than 5 % of molecules with carbon number less than 25ColourPasses testSulphurNot more than 0,4 %ArsenicNot more than 3 mg/kgLeadNot more than 3 mg/kgPolycyclic aromatic compoundsThe polycyclic aromatic hydrocarbons, obtained by extraction with dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits:nmMaximum absorbance per cm path length280-2890,15290-2990,12300-3590,08360-4000,02 E 907 HYDROGENATED POLY-1-DECENE SynonymsHydrogenated polydec-1-eneHydrogenated poly-alpha-olefinDefinitionChemical formulaC10nH20n+2 where n = 3-6Molecular weight560 (average)AssayNot less than 98,5 % of hydrogenated poly-1-decene, having the following oligomer distribution:C30: 13-37 %C40: 35-70 %C50: 9-25 %C60: 1-7 %DescriptionIdentification A. Solubility Insoluble in water; slightly soluble in ethanol; soluble in toluene B. Burning Burns with a bright flame and a paraffin-like characteristic smellPurityViscosityBetween 5,7 × 10-6 and 6,1 × 10-6 m2s-1 at 100 oCCompounds with carbon number less than 30Not more than 1,5 %Readily carbonisable substancesAfter 10 minutes shaking in a boiling water bath, a tube of sulphuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colourNickelNot more than 1 mg/kgLeadNot more than 1 mg/kg

E 912 MONTAN ACID ESTERS DefinitionMontan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerolChemical nameMontan acid estersDescriptionAlmost white to yellowish flakes, powder, granules or pelletsIdentification A. Density (20 oC) Between 0,98 and 1,05 B. Drop point Greater than 77 oCPurityAcid valueNot more than 40GlycerolNot more than 1 % (by gas chromatography)Other polyolsNot more than 1 % (by gas chromatography)Other wax typesNot detectable (by differential scanning calorimetry and/or infrared spectroscopy)ArsenicNot more than 2 mg/kgChromiumNot more than 3 mg/kgLeadNot more than 2 mg/kg E 914 OXIDISED POLYETHYLENE WAX DefinitionPolar reaction products from mild oxidation of polyethyleneChemical nameOxidised polyethyleneDescriptionAlmost white flakes, powder, granules or pelletsIdentification A. Density (20 oC) Between 0,92 and 1,05 B. Drop point Greater than 95 oCPurityAcid valueNot more than 70Viscosity at 120 oCNot less than 8,1 · 10-5 m2s-1Other wax typesNot detectable (by differential scanning calorimetry and/or infrared spectroscopy)OxygenNot more than 9,5 %ChromiumNot more than 5 mg/kgLeadNot more than 2 mg/kg E 920 L-CYSTEINE DefinitionL-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this substanceEinecs200-157-7 (anhydrous)Chemical formulaC3H7NO2S· HCl· n H20 (where n = 0 or 1)Molecular weight157,62 (anhydrous)AssayContent not less than 98,0 % and not more than 101,5 % on the anhydrous basisDescriptionWhite powder or colourless crystalsIdentification A. Solubility Freely soluble in water and in ethanol B. Melting range Anhydrous form melts at about 175 oC C. Specific rotation [α]20D: between +5,0o and +8,0o or[α]25D: between +4,9o and 7,9oPurityLoss on dryingBetween 8,0 % and 12,0 %Not more than 2,0 % (anhydrous form)Residue on ignitionNot more than 0,1 %Ammonium-ionNot more than 200 mg/kgArsenicNot more than 1,5 mg/kgLeadNot more than 5 mg/kg E 927b CARBAMIDE SynonymsUreaDefinitionEinecs200-315-5Chemical formulaCH4N2OMolecular weight60,06AssayContent not less than 99,0 % on the anhydrous basisDescriptionColourless to white, prismatic, crystalline powder or small, white pelletsIdentification A. Solubility Very soluble in waterSoluble in ethanol B. Precipitation with nitric acid To pass the test a white, crystalline precipitate is formed C. Colour reaction To pass the test a reddish-violet colour is produced D. Melting range 132 oC to 135 oCPurityLoss on dryingNot more than 1,0 % (105 oC, 1h)Sulphated ashNot more than 0,1 %Ethanol-insoluble matterNot more than 0,04 %AlkalinityPasses testAmmonium-ionNot more than 500 mg/kgBiuretNot more than 0,1 %ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kg E 938 ARGON DefinitionChemical nameArgonEinecs231-147-0Chemical formulaArMolecular weight40AssayNot less than 99 %DescriptionColourless, odourless, non-flammable gas PurityWaterNot more than 0,05 %Methane and other hydrocarbons calculated as methaneNot more than 100 μl/l

E 939 HELIUM DefinitionChemical nameHeliumEinecs231-168-5Chemical formulaHeMolecular weight4AssayNot less than 99 %DescriptionColourless, odourless, non-flammable gasPurityWaterNot more than 0,05 %Methane and other hydrocarbons calculated as methaneNot more than 100 μl/l E 941 NITROGEN DefinitionChemical nameNitrogenEinecs231-783-9Chemical formulaN2Molecular weight28AssayNot less than 99 %DescriptionColourless, odourless, non-flammable gasPurityWaterNot more than 0,05 %Carbon monoxideNot more than 10 μl/lMethane and other hydrocarbons calculated as methaneNot more than 100 μl/lNitrogen dioxide and nitrogen oxideNot more than 10 μl/lOxygenNot more than 1 % E 942 NITROUS OXIDE DefinitionChemical nameNitrous oxideEinecs233-032-0Chemical formulaN2OMolecular weight44AssayNot less than 99 %DescriptionColourless, non-flammable gas, sweetish odour PurityWaterNot more than 0,05 %Carbon monoxideNot more than 30 μl/lNitrogen dioxide and nitrogen oxideNot more than 10 μl/l E 943a BUTANE Synonymsn-ButaneDefinitionChemical nameButaneChemical formulaCH3CH2CH2CH3Molecular weight58,12AssayContent not less than 96 %DescriptionColourless gas or liquid with mild, characteristic odourIdentification A. Vapour pressure 108,935 kPa at 20 oCPurityMethaneNot more than 0,15 % v/vEthaneNot more than 0,5 % v/vPropaneNot more than 1,5 % v/vIsobutaneNot more than 3,0 % v/v1,3-butadieneNot more than 0,1 % v/vMoistureNot more than 0,005 % E 943b ISOBUTANE Synonyms2-methyl propaneDefinitionChemical name2-methyl propaneChemical formula(CH3)2CH CH3Molecular weight58,12AssayContent not less than 94 %DescriptionColourless gas or liquid with mild, characteristic odourIdentification A. Vapour pressure 205,465 kPa at 20 oCPurityMethaneNot more than 0,15 % v/vEthaneNot more than 0,5 % v/vPropaneNot more than 2,0 % v/vn-ButaneNot more than 4,0 % v/v1,3-butadieneNot more than 0,1 % v/vMoistureNot more than 0,005 % E 944 PROPANE DefinitionChemical namePropaneChemical formulaCH3CH2CH3Molecular weight44,09AssayContent not less than 95 %DescriptionColourless gas or liquid with mild, characteristic odourIdentification A. Vapour pressure 732,910 kPa at 20 oCPurityMethaneNot more than 0,15 % v/vEthaneNot more than 1,5 % v/vIsobutaneNot more than 2,0 % v/vn-ButaneNot more than 1,0 % v/v1,3-butadieneNot more than 0,1 % v/vMoistureNot more than 0,005 % E 948 OXYGEN DefinitionChemical nameOxygenEinecs231-956-9Chemical formulaO2Molecular weight32AssayNot less than 99 %DescriptionColourless, odourless, non-flammable gasPurityWaterNot more than 0,05 %Methane and other hydrocarbons calculated as methaneNot more than 100 μl/l E 949 HYDROGEN DefinitionChemical nameHydrogenEinecs215-605-7Chemical formulaH2Molecular weight2AssayContent not less than 99,9 %DescriptionColourless, odourless, highly flammable gasPurityWaterNot more than 0,005 % v/vOxygenNot more than 0,001 % v/vNitrogenNot more than 0,75 % v/v E 950 ACESULFAME K Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.

E 951 ASPARTAME Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC. E 953 ISOMALT Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC. E 957 THAUMATIN Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC. E 959 NEOHESPERIDINE DIHYDROCHALCONE Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC. E 965(i) MALTITOL Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC. E 965(ii) MALTITOL SYRUP Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC. E 966 LACTITOL Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC. E 967 XYLITOL Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC. E 999 QUILLAIA EXTRACT SynonymsSoapbark extract, Quillay bark extract, Panama bark extract, Quillai extract, Murillo bark extract, China bark extractDefinitionQuillaia extract is obtained by aqueous extraction of Quillaia saponaria Molina, or other Quillaia species, trees of the family Rosaceae. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and other minor componentsDescriptionQuillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution Identification A. pH of a 2,5 % solution Between 4,5 and 5,5PurityWaterNot more than 6,0 % (Karl Fischer method) (powder form only)ArsenicNot more than 2 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg E 1103 INVERTASE DefinitionInvertase is produced from Saccharomyces cerevisiaeSystematic nameβ-D-Fructofuranoside fructohydrolaseEnzyme Commission NoEC 3.2.1.26Einecs232-615-7PurityArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kgCadmiumNot more than 0,5 mg/kgTotal bacterial countNot more than 50000/gSalmonella spp.Absent by test in 25 gColiformsNot more than 30/gE. coliAbsent by test in 25 g E 1105 LYSOZYME SynonymsLysozyme hydrochlorideMuramidaseDefinitionLysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochlorideChemical nameEnzyme Commission (EC) No: 3.2.1.17Einecs232-620-4Molecular weightAbout 14000AssayContent not less than 950 mg/g on the anhydrous basisDescriptionWhite, odourless powder having a slightly sweet tasteIdentification A. Isoelectric point 10,7 B.

pH of a 2 % aqueous solution between 3,0 and 3,6 C. Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm PurityWater contentNot more than 6,0 % (Karl Fischer method) (powder form only)Residue on ignitionNot more than 1,5 % NitrogenNot less than 16,8 % and not more than 17,8 %ArsenicNot more than 1 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgHeavy metals (as Pb)Not more than 10 mg/kgMicrobiological criteriaTotal bacterial countNot more than 5 × 104 col/gSalmonellaeAbsent in 25 gStaphylococcus aureusAbsent in 1 gEscherichia coliAbsent in 1 g E 1200 POLYDEXTROSE SynonymsModified polydextrosesDefinitionRandomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may be neutralised with any food grade base and/or decolorised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextroseAssayContent not less than 90 % of polymer on the ash free and anhydrous basisDescriptionWhite to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured solutionIdentification A. Positive tests for sugar and for reducing sugar B. pH of a 10 % solution Between 2,5 and 7,0 for polydextroseBetween 5,0 and 6,0 for polydextrose-NPurityWaterNot more than 4,0 % (Karl Fischer method)Sulphated ashNot more than 0,3 % (polydextrose)Not more than 2,0 % (polydextrose N)NickelNot more than 2 mg/kg for hydrogenated polydextroses1,6-Anhydro-D-glucoseNot more than 4,0 % on the ash-free and the dried basisGlucose and sorbitolNot more than 6,0 % combined on the ash-free and the dried basis; glucose and sorbitol are determined separatelyMolecular weight limitNegative test for polymers of molecular weight greater than 220005-Hydroxy-methylfurfuralNot more than 0,1 % (polydextrose)Not more than 0,05 % (polydextrose-N)LeadNot more than 0,5 mg/kg E 1201 POLYVINYLPYRROLIDONE SynonymsPovidonePVPSoluble polyvinylpyrrolidoneDefinitionChemical namePolyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]Chemical formula(C6H9NO)nMolecular weightNot less than 25000AssayContent not less than 11,5 % and not more than 12,8 % of nitrogen (N) on the anhydrous basisDescriptionWhite or nearly white powderIdentification A. Solubility Soluble in water and in ethanol. Insoluble in ether B. pH of a 5 % solution Between 3,0 and 7,0PurityWaterNot more than 5 % (Karl Fischer)Total ashNot more than 0,1 %AldehydeNot more than 500 mg/kg (as acetaldehyde)Free-N-vinylpyrrolidoneNot more than 10 mg/kgHydrazineNot more than 1 mg/kgLeadNot more than 5 mg/kg

E 1202 POLYVINYLPOLYPYRROLIDONE SynonymsCrospovidoneCross linked polyvidoneInsoluble polyvinylpyrrolidoneDefinitionPolyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determinationChemical namePolyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]Chemical formula(C6H9NO)nAssayContent not less than 11 % and not more than 12,8 % nitrogen (N) on the anhydrous basisDescriptionA white hygroscopic powder with a faint, non-objectionable odourIdentification A. Solubility Insoluble in water, ethanol and ether B. pH of a 1 % suspension in water Between 5,0 and 8,0PurityWaterNot more than 6 % (Karl Fischer)Sulphated ashNot more than 0,4 %Water-soluble matterNot more than 1 %Free-N-vinylpyrrolidoneNot more than 10 mg/kgFree-N, N'-divinyl-imidazolidoneNot more than 2 mg/kgLeadNot more than 5 mg/kg E 1204 PULLULAN DefinitionLinear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food-grade hydrolysed starch using a non-toxin-producing strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatographyEinecs232-945-1Chemical formula(C6H10O5)xAssayNot less than 90 % of glucan on the dried basisDescriptionWhite to off-white odourless powderIdentification A. Solubility Soluble in water, practically insoluble in ethanol B. pH of 10 % solution 5,0 to 7,0 C. Precipitation with polyethylene glycol 600 Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed D. Depoly-merisation with pullulanase Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1 ml pullulanase solution having activity 10 units/g to one test tube, and 0,1 ml water to the other. After incubation at about 25 oC for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solutionPurityLoss on dryingNot more than 6 % (90 oC, pressure not more than 50 mm Hg, 6 h)Mono-, di- and oligosaccharidesNot more than 10 % expressed as glucoseViscosity100 to 180 mm2/s (10 % w/w aqueous solution at 30 oC)LeadNot more than 1 mg/kgYeast and mouldsNot more than 100 colonies per gramColiformsAbsent in 25 gSalmonellaAbsent in 25 g E 1404 OXIDISED STARCH DefinitionOxidised starch is starch treated with sodium hypochloriteDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starchesCarboxyl groupsNot more than 1,1 %Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specifiedArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kg E 1410 MONOSTARCH PHOSPHATE DefinitionMonostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphateDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour) Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starchesResidual phosphateNot more than 0,5 % (as P) for wheat or potato starchNot more than 0,4 % (as P) for other starchesSulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specifiedArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kg E 1412 DISTARCH PHOSPHATE DefinitionDistarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychlorideDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour) Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starchesResidual phosphateNot more than 0,5 % (as P) for wheat or potato starchNot more than 0,4 % (as P) for other starchesSulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specifiedArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kg E 1413 PHOSPHATED DISTARCH PHOSPHATE DefinitionPhosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphateDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour) Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starchesResidual phosphateNot more than 0,5 % (as P) for wheat or potato starchNot more than 0,4 % (as P) for other starchesSulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specifiedArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kg

E 1414 ACETYLATED DISTARCH PHOSPHATE DefinitionAcetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetateDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour) Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starchesAcetyl groupsNot more than 2,5 %Residual phosphateNot more than 0,14 % (as P) for wheat or potato starchNot more than 0,04 % (as P) for other starchesVinyl acetateNot more than 0,1 mg/kgSulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specifiedArsenicNot more than 1 mg/kg LeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kg E 1420 ACETYLATED STARCH SynonymsStarch acetateDefinitionAcetylated starch is starch esterified with acetic anhydride or vinyl acetateDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour) Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starchesAcetyl groupsNot more than 2,5 %Vinyl acetateNot more than 0,1 mg/kgSulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specifiedArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kg E 1422 ACETYLATED DISTARCH ADIPATE DefinitionAcetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydrideDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour) Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starchesAcetyl groupsNot more than 2,5 %Adipate groupsNot more than 0,135 %Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified ArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kg E 1440 HYDROXYPROPYL STARCH DefinitionHydroxypropyl starch is starch etherified with propylene oxideDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification

A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour) Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starchesHydroxypropyl groupsNot more than 7,0 %Propylene chlorohydrinNot more than 1 mg/kgSulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specifiedArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kg E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE DefinitionHydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxideDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour) Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starchesHydroxypropyl groupsNot more than 7,0 %Residual phosphateNot more than 0,14 % (as P) for wheat or potato starchNot more than 0,04 (as P) for other starchesPropylene chlorohydrinNot more than 1 mg/kg Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specifiedArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kg E 1450 STARCH SODIUM OCTENYL SUCCINATE SynonymsSSOSDefinitionStarch sodium octenyl succinate is starch esterified with octenylsuccinic anhydrideDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour) Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starchesOctenylsuccinyl groupsNot more than 3 %Octenylsuccinic acid residueNot more than 0,3 %Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specifiedArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kg E 1451 ACETYLATED OXIDISED STARCH DefinitionAcetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydrideDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starchesCarboxyl groupsNot more than 1,3 % Acetyl groupsNot more than 2,5 %Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specifiedArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kg E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE SynonymsSAOSDefinitionStarch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphateDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification A. If not pregelatinised: by microscopic observation B. Iodine staining positive (dark blue to light red colour) Purity (all values expressed on an anhydrous basis except for loss on drying)Loss on dryingNot more than 21,0 %Octenylsuccinyl groupsNot more than 3 %Octenylsuccinic acid residueNot more than 0,3 %Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for the other modified starches, unless otherwise specifiedArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kgAluminiumNot more than 0,3 % E 1505 TRIETHYL CITRATE SynonymsEthyl citrateDefinitionChemical nameTriethyl-2-hydroxypropan-1,2,3-tricarboxylateEinecs201-070-7Chemical formulaC12H20O7Molecular weight276,29AssayContent not less than 99,0 %DescriptionOdourless, practically colourless, oily liquidIdentification A. Specific gravity d2525: 1,135-1,139 B. Refractive index [n]D20: 1,439-1,441PurityWaterNot more than 0,25 % (Karl Fischer method)AcidityNot more than 0,02 % (as citric acid) ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kg E 1517 GLYCERYL DIACETATE SynonymsDiacetinDefinitionGlyceryl diacetate consist predominantly of a mixture of the 1,2- and 1,3-diacetates of glycerol, with minor amounts of the mono- and tri-estersChemical namesGlyceryl diacetate1, 2, 3-propanetriol diacetateChemical formulaC7H12O5Molecular weight176,17AssayNot less than 94,0 %DescriptionClear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odourIdentification A. Solubility Soluble in water. Miscible with ethanol B. Positive tests for glycerol and acetate C. Specific gravity d2020: 1,175-1,195 D. Boiling range Between 259 and 261 oCPurityTotal ashNot more than 0,02 %AcidityNot more than 0,4 % (as ascetic acid)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kg E 1518 GLYCERYL TRIACETATE SynonymsTriacetinDefinitionChemical nameGlyceryl triacetateEinecs203-051-9Chemical formulaC9H14O6Molecular weight218,21AssayContent not less than 98,0 %DescriptionColourless, somewhat oily liquid having a slightly fatty odourIdentification A. Positive tests for acetate and for glycerol B. Refractive index Between 1,429 and 1,431 at 25 oC

C. Specific gravity (25 oC/25 oC) Between 1,154 and 1,158 D. Boiling range Between 258 and 270 oCPurityWaterNot more than 0,2 % (Karl Fischer method)Sulphated ashNot more than 0,02 % (as citric acid)ArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kg E 1519 BENZYL ALCOHOL SynonymsPhenylcarbinolPhenylmethyl alcoholBenzenemethanolAlpha-hydroxytolueneDefinitionChemical namesBenzyl alcoholPhenylmethanolChemical formulaC7H8OMolecular weight108,14AssayNot less than 98,0 %DescriptionColourless, clear liquid with a faint, aromatic odourIdentification A. Solubility Soluble in water, ethanol and ether B. Refractive index [n]D20: 1,538-1,541 C. Specific gravity d2525: 1,042-1,047 D. Positive test for peroxides PurityDistillation rangeNot less than 95 % v/v distils between 202 and 208 oCAcid valueNot more than 0,5AldehydesNot more than 0,2 % v/v (as bezaldehyde)LeadNot more than 5 mg/kg E 1520 PROPANE-1,2-DIOL SynonymsPropylene glycolDefinitionChemical names1,2-dihydroxypropaneEinecs200-338-0Chemical formulaC3H8O2Molecular weight76,10AssayContent not less than 99,5 % on the anhydrous basisDescriptionClear, colourless, hygroscopic, viscous liquidIdentification A. Solubility Soluble in water, ethanol and acetone B. Specific gravity d2020: 1,035-1,040 C. Refractive index [n]20D: 1,431-1,433PurityDistillation range99 % v/v distils between 185 oC-189 oCSulphated ashNot more than 0,07 %WaterNot more than 1,0 % (Karl Fischer method)LeadNot more than 5 mg/kg POLYETHYLENE GLYCOL 6000 SynonymsPEG 6000Macrogol 6000DefinitionPolyethylene glycol 6000 is a mixture of polymers with the general formula H-(OCH2-CH)-OH corresponding to an average relative molecular mass of approximately 6000Chemical formula(C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6000, about 140)Molecular weight5600-7000AssayNot less than 90,0 % and not more than 110,0 %DescriptionA white or almost white solid with a waxy or paraffin-like appearanceIdentification A. Solubility Very soluble in water and in methylene chloride. Practically insoluble in alcohol, in ether and in fatty and mineral oils B. Melting range Between 55 oC and 61 oCPurityViscosityBetween 0,220 and 0,275 kgm-1s-1 at 20 oCHydroxyl valueBetween 16 and 22Sulphated ashNot more than 0,2 %Ethylene oxideNot more than 0,2 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 5 mg/kg

Annex

ANNEX II PART A Repealed Directive with list of its successive amendments (referred to in Article 2) Commission Directive 96/77/EC Commission Directive 98/86/EC Commission Directive 2000/63/EC Commission Directive 2001/30/EC Commission Directive 2002/82/EC Commission Directive 2003/95/EC Commission Directive 2004/45/EC Commission Directive 2006/129/EC (OJ L 339, 30.12.1996, p. 1) (OJ L 334, 9.12.1998, p. 1) (OJ L 277, 30.10.2000, p. 1) (OJ L 146, 31.5.2001, p. 1) (OJ L 292, 28.10.2002, p. 1) (OJ L 283, 31.10.2003, p. 71) (OJ L 113, 20.4.2004, p. 19) (OJ L 346, 9.12.2006, p. 15) PART B List of time-limits for transposition into national law

(referred to in Article 2) According to Article 3(2) of Directive 96/77/EC, 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. According to Article 2(2) of Directive 98/86/EC, products put on the market or labelled before 1 July 1999 which do not comply with this Directive may be marketed until stocks are exhausted. According to Article 2(3) of Directive 2000/63/EC, products put on the market or labelled before 31 March 2001 which do not comply with this Directive may be marketed until stocks are exhausted. According to Article 2(3) of Directive 2001/30/EC, products put on the market or labelled before 1 June 2002 which do not comply with this Directive may be marketed until stocks are exhausted. According to Article 3 of Directive 2003/95/EC, products put on the market or labelled before 1 November 2004 which do not comply with this Directive may be marketed until stocks are exhausted. According to Article 3 of Directive 2004/45/EC, products put on the market or labelled before 1 April 2005 which do not comply with this Directive may be marketed until stocks are exhausted. DirectiveTime-limit for transposition96/77/EC1 July 199798/86/EC1 July 19992000/63/EC31 March 20012001/30/EC1 June 20022002/82/EC31 August 20032003/95/EC1 November 20042004/45/EC1 April 20052006/129/EC15 February 2008

Annex

ANNEX III Correlation table Directive 96/77/ECThis DirectiveArticle 1Article 1Article 2—Article 3——Article 2Article 4Article 3Article 5Article 4AnnexAnnex I—Annex II—Annex III

Metadata

Type: Direktiv
År: 2008
Ikrafttrædelsesdato: 1. januar 1970