CELEX: 31996L0077
Language: mt
Date: 1996-12-02 00:00:00
Title: Id-Direttiva tal-Kummissjoni 96/77/KE tat-2 ta’ Diċembru 1996 li tispeċifika l-kriterja tal-purità rigward l-addittivi ta’ l-ikel apparti mill-kuluri u s-sustanzi li jagħtu l-ħlewwaTest b’rilevanza għaż-ŻEE

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31996L0077

Official Journal L 339 , 30/12/1996 P. 0001 - 0069

		Id-Direttiva tal-Kummissjoni 96/77/KEtat-2 ta’ Diċembru 1996li tispeċifika l-kriterja tal-purità rigward l-addittivi ta’ l-ikel apparti mill-kuluri u s-sustanzi li jagħtu l-ħlewwa(Test b’rilevanza għaż-ŻEE)IL-KUMMISSJONI TAL-KOMUNITAJIET EWROPEJ,Wara li kkunsidrat it-Trattat li jistabbilixxi l-Komunità Ewropea,Wara li kkunsidrat id-Direttiva tal-Kunsill 89/107/KEE tal-21 ta’ Diċembru 1988 dwar l-approssimazzjoni tal-liġijiet tal-Istati Membri li jirrigwardaw l-addittivi ma’ l-ikel awtorizzati għall-użu fl-oġġetti ta’ l-ikel maħsuba għall-konsum mill-bniedem [1], kif emendata bid-Direttiva 94/34/KE tal-Parlament Ewropew u tal-Kunsill [2], u partikolarment l-Artikolu 3(3)(a) tagħha,Wara li kkonsultat lill-Kumitat Xjentifiku dwar l-Ikel,Billi huwa meħtieġ li jkunu stabbiliti l-kriterja tal-purità għall-addittivi kollha minbarra l-kuluri u s-sustanzi li jagħtu l-ħlewwa msemmija fid-Direttiva tal-Parlament Ewropew u tal-Kunsill 95/2/KE ta’ l-20 ta’ Frar 1995 dwar addittivi ta’ l-ikel għajr il-kuluri u s-sustanzi li jagħtu l-ħlewwa [3];Billi huwa meħtieġ li jinbidlu l-kriterja tal-purità stabbiliti fid-Direttiva tal-Kunsill 65/66/KEE tas-26 ta’ Jannar 1965 li tistabbilixxi l-kriterja speċifika tal-purità għall-preservattivi awtorizzati għall-użu fl-ikel intiż għal konsum uman [4], kif l-aħħar emendata bid-Direttiva 86/604/KEE [5];Billi huwa meħtieġ li jinbidlu il-kriterji tal-purita stabbiliti fid-Direttiva tal-Kunsill 78/664/KEE tas-25 ta’ Lulju 1978 li tistabbilixxi l-kriterji speċifiċi tal-purità għal antiossidanti li jistgħu jintużaw fl-ikel intiż għal konsum uman [6], kif l-aħħar emendata bid-Direttiva 82/712/KEE [7];Billi d-Direttivi 65/66/KEE u 78/664/KEE għandhom ikunu mħassra kif xieraq;Billi huwa meħtieġ li tittieħed konsiderazzjoni tal-ispeċifikazzjonijiet u t-tekniki analitiċi għall-addittivi kif stabbiliti fil-Codex Alimentarius kif abbozzati mill-Kumitat Konġunt ta’ l-Esperti tal-FAO/WHO dwar l-Additivi ta’ l-Ikel (Jecfa);Billi l-addittivi ta’ l-ikel, jekk imħejjija b’metodi ta’ preparazzjoni jew materjali tal-bidu sinifikantament differenti minn dawk inklużi fl-evalwazzjoni tal-Kumitat Xjentifiku ta’ l-Ikel, jew jekk differenti minn dawk imsemmija f’din id-Direttiva, għandhom ikunu ippreżentati għall-valutazzjoni tal-Kumitat Xjentifiku dwar l-Ikel għall-iskopijiet ta’ l-valutazzjoni sħiħa b’enfasi fuq il-kriterji tal-purità;Billi l-miżuri li hemm disposizzjoniji dwarhom f’din id-Direttiva huma bi qbil ma l-opinjoni tal-Kumitat Permanenti dwar l-oġġetti ta’ l-ikel,ADOTTAT DIN ID-DIRETTIVA:L-Artikolu 1Il-kriterji tal-purità msemmija fl-Artikolu 3(3)(a) tad-Direttiva 89/107/KEE għall-addittivi ta’ l-ikel apparti mill-kuluri u s-sustanzi li jagħtu l-ħlewwa, kif imsemmija fid-Direttiva 95/2/KE, huma stabbiliti fl-Anness ma’ din.L-Artikolu 2Id-Direttivi 65/66/KEE u 78/664/KEE huma b’hekk imħassra.L-Artikolu 31. L-Istati Membri għandhom idaħħlu fis-seħħ il-liġijiet, ir-regolamenti u d-dispożizzjonijiet amministrativi meħtieġa sabiex ikunu konformi ma’ din id-Direttiva qabel l-1 ta’ Lulju 1997. Huma għandhom immedjatament jinfurmaw b’dan lill-Kummissjoni.Meta l-Istati Membri jadottaw dawn id-dispożizzjonijiet, dawn għandhom ikollhom referenza għal din id-Direttiva jew għandhom ikunu akkumpanjati b’din ir-referenza fil-waqt tal-pubblikazzjoni uffiċjali tagħhom. Il-proċedura għal din ir-referenza għandha tkun adottata mill-Istati Membri.2. Il-prodotti mqiegħda fis-suq jew ittikkettjati qabel l-1 ta’ Lulju 1997 li ma jkunux konformi ma din id-Direttiva jistgħu jkunu kummerċjalizzati sa kemm il-ħażniet ikunu eżawriti.L-Artikolu 4Din id-Direttiva għandha tidħol fis-seħħ fil-20 jum li jiġi wara dak tal-pubblikazzjoni tagħha fil-Ġurnal Uffiċjali tal-Komunitajiet Ewropej.L-Artikolu 5Din id-Direttiva hija indirizzata lill-Istati Membri.Magħmula fi Brussel, fit-2 ta’ Diċembru 1996.Għall-KummissjoniMartin bangemannMembru tal-Kummissjoni[1] OJ No L 40, 11.2.1989, p.27.[2] OJ No L 237, 10.9.1994, p.1.[3] OJ No L 61, 18.3.1995, p.1.[4] OJ No L 22, 9.2.1965, p.373.[5] OJ No L 352, 13.12.1986, p.45.[6] OJ No L 223, 14.8.1978, p.30.[7] OJ No L 297, 23.10.1982, p.31.--------------------------------------------------L-ANNESSI| || |E 200 SORBIC ACIDDefinitionChemical name | Sorbic acid Trans, trans-2,4-hexadienoic acid |Einecs | 203-768-7 |Chemical formula | C6H8O2 |Molecular weight | 112,12 |Assay | Content not less than 99 % on the anhydrous basis |Description | Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 °C |IdentificationA.Melting range | Between 133 °C and 135 °C, after vacuum drying for four hours in a sulphuric acid desiccator |B.Spectrometry | An isopropanol solution (1 in 4000000) shows absorbance maximum at 254 ± 2 nm |C.Positive test for double bonds | | |D.Sublimation point | 80 °C |PurityWater content | Not more than 0,5 % (Karl Fischer method) |Sulphated ash | Not more than 0,2 % |Aldehydes | Not more than 0,1 % (as formaldehyde) |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 202 POTASSIUM SORBATEDefinitionChemical name | Potassium sorbate Potassium (E,E)-2,4-hexadienoate Potassium salt of trans, trans 2,4-hexadienoic acid |Einecs | 246-376-1 |Chemical formula | C6H7O2K |Molecular weight | 150,22 |Assay | Content not less than 99 % on the dried basis |Description | White crystalline powder showing no change in colour after heating for 90 minutes at 105 °C |IdentificationA.Melting range of sorbic acid isolated by acidification and not recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator | | |B.Positive tests for potassium and for double bonds | | |PurityLoss on drying | Not more than 1,0 % (105 °C, 3h) |Acidity or alkalinity | Not more than about 1,0 % (as sorbic acid or K2CO3) |Aldehydes | Not more than 0,1 %, calculated as formaldehyde |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 203 CALCIUM SORBATEDefinitionChemical name | Calcium sorbate Calcium salts of trans, trans-2,4-hexadienoic acid |Einecs | 231-321-6 |Chemical formula | C12H14O4Ca |Molecular weight | 262,32 |Assay | Content not less than 98 % on the dried basis |Description | Fine white crystalline powder not showing any change in colour after heating at 105 °C for 90 minutes |IdentificationA.Melting range of sorbic acid isolated by acidification and not recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator | | |B.Positive tests for calcium and for double bonds | | |PurityLoss on drying | Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator |Aldehydes | Not more than 0,1 % (as formaldehyde) |Fluoride | Not more than 10 mg/kg |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 210 BENZOIC ACIDDefinitionChemical name | Benzoic acid Benzenecarboxylic acid Phenylcarboxylic acid |Einecs | 200-618-2 |Chemical formula | C7H6O2 |Molecular weight | 122,12 |Assay | Content not less than 99,5 % on the anhydrous basis |Description | White crystalline powder |IdentificationA.Melting range | 121,5 °C to 123,5 °C |B.Positive sublimation test and test for benzoate | | |PurityLoss on drying | Not more than 0,5 % after drying for three hours over sulphuric acid |pH | About 4 (solution in water) |Sulphated ash | Not more than 0,05 % |Chlorinated organic compounds | Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid |Readily oxidizable substances | Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required |Readily carbonizable substances | A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSCand 4,4 ml of water |Polycyclic acids | On fractional acidification of a neutralized solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 211 SODIUM BENZOATEDefinitionChemical name | Sodium benzoate Sodium salt of benzenecarboxylic acid Sodium salt of phenylcarboxylic acid |Einecs | 208-534-8 |Chemical formula | C7H5O2Na |Molecular weight | 144,11 |Assay | Not less than 99 % of C7H5O2Na, after drying at 105 °C for four hours |Description | A white, almost odourless, crystalline powder or granules |IdentificationA.Solubility | Freely soluble in water, sparingly soluble in ethanol |B.Melting range for benzoic acid | Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after drying in a sulphuric acid desiccator |C.Positive tests for benzoate and for sodium | | |PurityLoss on drying | Not more than 1,5 % after drying at 105 °C for four hours |Readily oxidizable substances | Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required |Polycyclic acids | On fractional acidification of a (neutralized) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid |Chlorinated organic compounds | Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid |Degree of acidity or alkalinity | Neutralization of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 212 POTASSIUM BENZOATEDefinitionChemical name | Potassium benzoate Potassium salt of benzenecarboxylic acid Potassium salt of phenylcarboxylic acid |Einecs | 209-481-3 |Chemical formula | C7H5KO2·3H2O |Molecular weight | 214,27 |Assay | Content not less than 99 % C7H5O2K after drying at 105 °C to constant weight |Description | White crystalline powder |IdentificationA.Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator | | |B.Positive tests for benzoate and for potassium | | |PurityLoss on drying | Not more than 26,5 %, determined by drying at 105 °C |Chlorinated organic compounds | Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid |Readily oxidizable substances | Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required |Readily carbonizable substances | A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water |Polycyclic acids | On fractional acidification of a (neutralized) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid |Degree of acidity or alkalinity | Neutralization of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 213 CALCIUM BENZOATESynonyms | Monocalcium benzoate |DefinitionChemical name | Calcium benzoate Calcium dibenzoate |Einecs | 218-235-4 |Chemical formula | Anhydrous: | C14H10O4Ca |Monohydrate: | C14H10O4Ca·H2O |Trihydrate: | C14H10O4CA·3H2O |Molecular weight | Anhydrous: | 282,31 |Monohydrate: | 300,32 |Trihydrate: | 336,36 |Assay | Content not less than 99 % after drying at 105 °C |Description | White or colourless crystals, or white powder |IdentificationA.Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator | | |B.Positive tests for benzoate and for calcium | | |PurityLoss on drying | Not more than 17,5 % determined by drying at 105 °C to constant weight |Water insoluble matter | Not more than 0,3 % |Chlorinated organic compounds | Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acids |Readily oxidizable substances | Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required |Readily carbonizable substances | Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water |Polycyclic acids | On fractional acidification of a (neutralized) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid |Degree of acidity or alkalinity | Neutralization of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl |Fluoride | Not more than 10 mg/kg |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 214 ETHYL p-HYDROXYBENZOATESynonyms | Ethylparaben Ethyl p-oxybenzoate |DefinitionChemical name | Ethyl-p-hydroxybenzoate Ethyl ester of p-hydroxybenzoic acid |Einecs | 204-399-4 |Chemical formula | C9H10O3 |Molecular weight | 166,8 |Assay | Content not less than 99,5 % after drying for two hours at 80 °C |Description | Almost odourless, small, colourless crystals or a white, crystalline powder |IdentificationA.Melting range | 115 °C to 118 °C |B.Positive test for p-hydroxybenzoate | Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallized: 213 °C to 217 °C, after vacuum drying in a sulphuric acid desiccator |C.Positive test for alcohol | | |PurityLoss on drying | Not more than 0,5 % after drying for two hours at 80 °C |Sulphated ash | Not more than 0,05 % |p-Hydroxybenzoic acid and salicylic acid | Not more than 0,35 % expressed as p-hydroxybenzoic acid |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 215 SODIUM ETHYL p-HYDROXYBENZOATEDefinitionChemical name | Sodium ethyl p-hydroxybenzoate Sodium compound of the ethyl ester of p-hydroxybenzoic acid |Einecs | 252-487-6 |Chemical formula | C9H9O3Na |Molecular weight | 188,8 |Assay | Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis |Description | White, crystalline hygroscopic powder |IdentificationA.Melting range | 115 °C to 118 °C, after vacuum drying in a sulphuric acid desiccator |B.Positive test for p-hydroxybenzoate | Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C |C.Positive test for sodium | | |D.pH of a 0,1 % aqueous solution must be between 9,9 and 10,3 | | |PurityLoss on drying | Not more than 5 %, determined by vacuum drying in a sulphuric acid desiccator |Sulphated ash | 37 to 39 % |p-Hydroxybenzoic acid and salicylic acid | Not more than 0,35 % expressed as p-hydroxybenzoic acid |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 216 PROPYL p-HYDROXYBENZOATESynonyms | Propylparaben Propyl p-oxybenzoate |DefinitionChemical name | Propyl p-hydroxybenzoate n-Propyl p-hydroxybenzoic acid |Einecs | 202-307-7 |Chemical formula | C10H12O3 |Molecular weight | 180,21 |Assay | Content not less than 99,5 % after drying for two hours at 80 °C |Description | Almost odourless, small, colourless crystals or a white, crystalline powder |IdentificationA.Melting range | 95 °C to 97 °C after drying for two hours at 80 °C |B.Positive test for p-hydroxybenzoate | Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C |PurityLoss on drying | Not more than 0,5 % after drying for two hours at 80 °C |Sulphated ash | Not more than 0,05 % |p-Hydroxybenzoic acid and salicylic acid | Not more than 0,35 % expressed as p-hydroxybenzoic acid |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 217 SODIUM PROPYL p-HYDROXYBENZOATEDefinitionChemical name | Sodium n-propyl p-hydroxybenzoate Sodium compound of the n-propylester of p-hydroxybenzoic acid |Einecs | 252-488-1 |Chemical formula | C10H11O3Na |Molecular weight | 202,21 |Assay | Content of the propyl ester of p-hydroxybenzoic acid not less than 85 % on the anhydrous basis |Description | White, or almost white, crystalline hygroscopic powder |IdentificationA.Melting range of ester isolated by acidification and not recrystallized: 94 °C to 97 °C, after vacuum drying in a sulphuric acid desiccator | | |B.Positive test for sodium | | |C.pH of a 0,1 % aqueous solution must be between 9,8 and 10,2 | | |PurityLoss on drying | Not more than 5 %, determined by vacuum drying in a sulphuric acid desiccator |Sulphated ash | 34 to 36 % |p-Hydroxybenzoic acid and salicylic acid | Not more than 0,35 % expressed as p-hydroxybenzoic acid |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 218 METHYL p-HYDROXYBENZOATESynonyms | Methylparaben Methyl-p-oxybenzoate |DefinitionChemical name | Methyl p-hydroxybenzoate Methyl ester of p-hydroxybenzoic acid |Einecs | 243-171-5 |Chemical formula | C8H8O3 |Molecular weight | 152,15 |Assay | Content not less than 99 % after drying for two hours at 80 °C |Description | Almost odourless, small colourless crystals or white crystalline powder |IdentificationA.Melting range | 125 °C to 128 °C |B.Positive test for p-hydroxybenzoate | Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C after drying for two hours at 80 °C |PurityLoss on drying | Not more than 0,5 %, after drying for two hours at 80 °C |Sulphated ash | Not more than 0,05 % |p-Hydroxybenzoic acid and salicylic acid | Not more than 0,35 % expressed as p-hydroxybenzoic acid |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 219 SODIUM METHYL p-HYDROXYBENZOATEDefinitionChemical name | Sodium methyl p-hydroxybenzoate Sodium compound of the methylester of p-hydroxybenzoic acid |Chemical formula | C8H7O3Na |Molecular weight | 174,15 |Assay | Content not less than 99,5 % on the anhydrous basis |Description | White, hygroscopic powder |IdentificationA.The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methyl p-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80 °C for two hours, have a melting range of 125 °C to 128 °C | | |B.Positive test for sodium | | |C.pH of a 0,1 % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3 | | |PurityWater content | Not more than 5 % (Karl Fischer method) |Sulphated ash | 40 % to 44,5 % on the anhydrous basis |p-Hydroxybenzoic acid and salicylic acid | Not more than 0,35 % expressed as p-hydroxybenzoic acid |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 220 SULPHUR DIOXIDEDefinitionChemical name | Sulphur dioxide Sulphurous acid anhydride |Einecs | 231-195-2 |Chemical formula | SO2 |Molecular weight | 64,07 |Assay | Content not less than 99 % |Description | Colourless, non-flammable gas with strong pungent suffocating odour |IdentificationA.Positive test for sulphurous substances | | |PurityWater content | Not more than 0,05 % |Non-volatile residue | Not more than 0,01 % |Sulphur trioxide | Not more than 0,1 % |Selenium | Not more than 10 mg/kg |Other gases not normally present in the air | No trace |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 221 SODIUM SULPHITEDefinitionChemical name | Sodium sulphite (anhydrous or heptahydrate) |Einecs | 231-821-4 |Chemical formula | Anhydrous: | Na2SO3 |Heptahydrate: | Na2SO37H2O |Molecular weight | Anhydrous: | 126,04 |Heptahydrate: | 252,16 |Assay | Anhydrous: | Not less than 95 % of Na2SO3 and not less than 48 % of SO2 |Heptahydrate: | Not less than 48 % of Na2SO3 and not less than 24 % of SO2 |Description | White crystalline powder or colourless crystals |IdentificationA.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 | | |PurityThiosulphate | Not more than 0,1 % based on the SO2 content |Iron | Not more than 50 mg/kg based on the SO2 content |Selenium | Not more than 10 mg/kg based on the SO2 content |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 222 SODIUM BISULPHITEDefinitionChemical name | Sodium bisulphite Sodium hydrogen sulphite |Einecs | 231-921-4 |Chemical formula | NaHSO3 in aqueous solution |Molecular weight | 104,06 |Assay | Content not less than 32 % w/w NaHSO3 |Description | A clear, colourless to yellow solution |IdentificationA.Positive tests for sulphite and for sodium | | |B.pH of a 10 % aqueous solution between 2,5 and 5,5 | | |PurityIron | Not more than 50 mg/kg of Na2SO3 based on the SO2 content |Selenium | Not more than 10 mg/kg based on the SO2 content |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 223 SODIUM METABISULPHITESynonyms | Pyrosulphite Sodium pyrosulphite |DefinitionChemical name | Sodium disulphite Disodium pentaoxodisulphate |Einecs | 231-673-0 |Chemical formula | Na2S2O5 |Molecular weight | 190,11 |Assay | Content not less than 95 % Na2S2O5 and not less than 64 % of SO2 |Description | White crystals or crystalline powder |IdentificationA.Positive tests for sulphite and for sodium | | |B.pH of a 10 % aqueous solution between 4,0 and 5,5 | | |PurityThiosulphate | Not more than 0,1 % based on the SO2 content |Iron | Not more than 50 mg/kg based on the SO2 content |Selenium | Not more than 10 mg/kg based on the SO2 content |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 224 POTASSIUM METABISULPHITESynonyms | Potassium pyrosulphite |DefinitionChemical name | Potassium disulphite Potassium pentaoxo disulphate |Einecs | 240-795-3 |Chemical formula | K2S2O5 |Molecular weight | 222,33 |Assay | Content not less than 90 % of K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate |Description | Colourless crystals or white crystalline powder |IdentificationA.Positive tests for sulphite and for potassium | | |PurityThiosulphate | Not more than 0,1 % based on the SO2 content |Iron | Not more than 50 mg/kg based on the SO2 content |Selenium | Not more than 10 mg/kg based on the SO2 content |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 226 CALCIUM SULPHITEDefinitionChemical name | Calcium sulphite |Einecs | 218-235-4 |Chemical formula | CaSO3·2H2O |Molecular weight | 156,17 |Assay | Content not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2 |Description | White crystals or white crystalline powder |IdentificationA.Positive tests for sulphite and for calcium | | |PurityIron | Not more than 50 mg/kg based on the SO2 content |Selenium | Not more than 10 mg/kg based on the SO2 content |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 227 CALCIUM BISULPHITEDefinitionChemical name | Calcium bisulphite Calcium hydrogen sulphite |Einecs | 237-423-7 |Chemical formula | Ca(HSO3)2 |Molecular weight | 202,22 |Assay | 6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO3)2] |Description | Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide |IdentificationA.Positive tests for sulphite and for calcium | | |PurityIron | Not more than 50 mg/kg based on the SO2 content |Selenium | Not more than 10 mg/kg based on the SO2 content |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 228 POTASSIUM BISULPHITEDefinitionChemical name | Potassium bisulphite Potassium hydrogen sulphite |Einecs | 231-870-1 |Chemical formula | KHSO3 in aqueous solution |Molecular weight | 120,17 |Assay | Content not less than 280 g KHSO3 per litre (or 150 g SO2 per litre) |Description | Clear colourless aqueous solution |IdentificationA.Positive tests for sulphite and for potassium | | |PurityIron | Not more than 50 mg/kg based on the SO2 content |Selenium | Not more than 10 mg/kg based on the SO2 content |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 230 BIPHENYLSynonyms | Diphenyl |DefinitionChemical name | 1,1′-biphenyl Phenylbenzene |Einecs | 202-163-5 |Chemical formula | C12H10 |Molecular weight | 154,20 |Assay | Content not less than 99,8 % |Description | White or pale yellow to amber crystalline solid having a characteristic odour |IdentificationA.Melting range | 68,5 °C to 70,5 °C |B.Distillation range | It distils completely within a 2,5 °C range between 252,5 °C and 257,5 °C |PurityBenzene | Not more than 10 mg/kg |Aromatic amines | Not more than 2 mg/kg (as aniline) |Phenol derivatives | Not more than 5 mg/kg (as phenol) |Readily carbonizable substances | Cold solution of 0,5 g of biphenyl in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water |Terphenyl and higher polyphenyl derivatives | Not more than 0,2 % |Polycyclic aromatic hydrocarbons | Absent |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 231 ORTHOPHENYLPHENOLSynonyms | Orthoxenol |DefinitionChemical name | (1,1'-Biphenyl)-2-ol 2-Hydroxydiphenyl o-Hydroxydiphenyl |Einecs | 201-993-5 |Chemical formula | C12H10O |Molecular weight | 170,20 |Assay | Content not less than 99 % |Description | White or slightly yellowish crystalline powder |IdentificationA.Melting range | 56 °C to 58 °C |B.Positive test for phenolate | An ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solution |PuritySulphated ash | Not more than 0,05 % |Diphenyl ether | Not more than 0,3 % |p-Phenylphenol | Not more than 0,1 % |1-Naphthol | Not more than 0,01 % |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 232 SODIUM ORTHOPHENYLPHENOLSynonyms | Sodium orthophenylphenate Sodium salt of o-phenylphenol |DefinitionChemical name | Sodium orthophenylphenol |Einecs | 205-055-6 |Chemical formula | C12H9ONa·4H2O |Molecular weight | 264,26 |Assay | Content not less than 97 % of C12H9ONa·4H2O |Description | White or slightly yellowish crystalline powder |IdentificationA.Positive tests for phenolate and for sodium | | |B.Melting range of orthophenylphenol isolated by acidification and not recrystallized derived from the sample 56 °C to 58 °C after drying in a sulphuric acid desiccator | | |C.pH of a 2 % aqueous solution must be between 11,1 and 11,8 | | |PurityDiphenylether | Not more than 0,3 % |p-phenylphenol | Not more than 0,1 % |1-naphthol | Not more than 0,01 % |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 233 THIABENDAZOLEDefinitionChemical name | 4-(2-benzimidazolyl)thiazole 2-(4-thiazolyl)-1H-benzimidazole |Einecs | 1205-725-8 |Chemical formula | C10H7N3S |Molecular weight | 201,26 |Assay | Content not less than 98 % on the anhydrous basis |Description | White, or almost white, odourless powder |IdentificationA.Melting range | 296 °C to 303 °C |B.Spectrometry | Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nm E 1 cm1 % at 302 nm ± 2 nm: approximately 1230 E 1 cm1 % at 258 nm ± 2 nm: approximately 200 E 1 cm1 % at 243 nm ± 2 nm: approximately 620 Ratio of absorption 243 nm/302 nm = 0,47 to 0,53 Ratio of absorption 258 nm/302 nm = 0,14 to 0,18 |PurityWater content | Not more than 0,5 % (Karl Fischer method) |Sulphated ash | Not more than 0,2 % |Selenium | Not more than 3 mg/kg |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 234 NISINDefinition | Nisin consists of several closely related polypeptides produced by natural strains of Streptococcus lactis, Lancefield group N |Einecs | 215-807-5 |Chemical formula | C143H230N42O37S7 |Molecular weight | 3354,12 |Assay | Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 % |Description | White powder |PurityLoss on drying | Not more than 3 % when dried to constant weight at 102 °C to 103 °C |Arsenic | Not more than 1 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 235 NATAMYCINSynonyms | Pimaricin |Definition | Natamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis |Einecs | 231-683-5 |Chemical formula | C33H47O13N |Molecular weight | 665,74 |Assay | Content not less than 95 % on the anhydrous basis |Description | White to creamy-white crystalline powder |IdentificationA.Colour reactions | On adding a few crystals of natamycin on a spot plate, to a drop of: concentrated hydrochloric acid, a blue colour develops,concentrated phosphoric acid, a green colour develops,which changes into pale red after a few minutes |B.Spectrometry | A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm |C.pH | 5,5 to 7,5 (1 % w/v solution in previously neutralized mixture of 20 parts dimethylformamide and 80 parts of water) |D.Specific rotation | αD20+ 250 ° to + 295 ° (a 1 % w/v solution in glacial acetic acid, at 20 °C and calculated with reference to the dried material) |PurityLoss on drying | Not more than 8 % (over P2O5, in vacuum at 60 °C to constant weight) |Sulphated ash | Not more than 0,5 % |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |Microbiological criteria: total viable count | Not more than 100/g |E 239 HEXAMETHYLENE TETRAMINESynonyms | Hexamine Methenamine |DefinitionChemical name | 1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine |Einecs | 202-905-8 |Chemical formula | C6H12N4 |Molecular weight | 140,19 |Assay | Content not less than 99 % on the anhydrous basis |Description | Colourless or white crystalline powder |IdentificationA.Positive tests for formaldehyde and for ammonia | | |B.Sublimation point approximately 260 °C | | |PurityLoss on drying | Not more than 0,5 % after drying at 105 °C in vacuum over P2O5 for two hours |Sulphated ash | Not more than 0,05 % |Sulphates | Not more than 0,005 % expressed as SO4 |Chlorides | Not more than 0,005 % expressed as Cl |Ammonium salts | Not detectable |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 242 DIMETHYL DICARBONATESynonyms | DMDC Dimethyl pyrocarbonate |DefinitionEinecs | 224-859-8 |Chemical name | Dimethyl dicarbonate Pyrocarbonic acid dimethyl ester |Chemical formula | C4H6O5 |Molecular weight | 134,09 |Assay | Content not less than 99,8 % |Description | Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion |IdentificationA.Decomposition | After dilution positive tests for CO2 and methanol |B. Melting point Boiling point | 17 °C 172 °C with decomposition |C.Density 20 °C | Approximately 1,25 g/cm3 |D.Infrared spectrum | Maxima at 1156 and 1832 cm− 1 |PurityDimethyl carbonate | Not more than 0,2 % |Chlorine, total | Not more than 3 mg/kg |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 249 POTASSIUM NITRITEDefinitionChemical name | Potassium nitrite |Einecs | 231-832-4 |Chemical formula | KNO2 |Molecular weight | 85,11 |Assay | Content not less than 95 % on the anhydrous basis |Description | White or slightly yellow, deliquescent granules |IdentificationA.Positive tests for nitrite and for potassium | | |B.pH of a 5 % solution: not less than 6,0 and not more than 9,0 | | |PurityLoss on drying | Not more than 3 % after drying for four hours over silica gel |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 250 SODIUM NITRITEDefinitionChemical name | Sodium nitrite |Einecs | 231-555-9 |Chemical formula | NaNO2 |Molecular weight | 69,00 |Assay | Content not less than 97 % on the anhydrous basis |Description | White crystalline powder or yellowish lumps |IdentificationA.Positive tests for nitrite and for sodium | | |PurityLoss on drying | Not more than 0,25 % after drying over silica gel for four hours |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 251 SODIUM NITRATESynonyms | Chile saltpetre Cubic or soda nitre |DefinitionChemical name | Sodium nitrate |Einecs | 231-554-3 |Chemical formula | NaNO3 |Molecular weight | 85,00 |Assay | Content not less than 99 % after drying at 105 °C for four hours |Description | White crystalline, slightly hygroscopic powder |IdentificationA.Positive tests for nitrate and for sodium | | |B.pH of a 5 % solution | Not less than 5,5 and more than 8,3 |C.Melting point: ± 308 °C | | |PurityLoss on drying | Not more than 2 % after drying at 105 °C for four hours |Nitrites | Not more than 30 mg/kg expressed as NaNO2 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 252 POTASSIUM NITRATESynonyms | Chile saltpetre Cubic or soda nitre |DefinitionChemical name | Potassium nitrate |Einecs | 231-818-8 |Chemical formula | KNO3 |Molecular weight | 101,11 |Assay | Content not less than 99 % on the anhydrous basis |Description | White crystalline powder or transparent prisms having a cooling, saline, pungent taste |IdentificationA.Positive tests for nitrate and for potassium | | |B.pH of a 5 % solution | Not less than 4,5 and not more than 8,5 |PurityLoss on drying | Not more than 1 % after drying at 105 °C for four hours |Nitrites | Not more than 20 mg/kg expressed as KNO2 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 260 ACETIC ACIDDefinitionChemical name | Acetic acid Ethanoic acid |Einecs | 200-580-7 |Chemical formula | C2H4O2 |Molecular weight | 60,05 |Assay | Content not less than 99,8 % |Description | Clear, colourless liquid having a pungent, characteristic odour |IdentificationA.Boiling point | 118 °C at 760 mm pressure (of mercury) |B.Specific gravity | About 1,049 |C.A one in three solution gives positive tests for acetate | | |D.Solidification point | Not lower than 14,5 °C |PurityNon-volatile residue | Not more than 100 mg/kg |Formic acid, formates and other oxidizable substances | Not more than 1000 mg/kg expressed as formic acid |Readily oxidizable substances | Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes |Arsenic | Not more than 1 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 261 POTASSIUM ACETATEDefinitionChemical name | Potassium acetate |Einecs | 204-822-2 |Chemical formula | C2H3O2K |Molecular weight | 98,14 |Assay | Content not less than 99 % on the anhydrous basis |Description | Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour |IdentificationA.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 drying | Not more than 8 % after drying at 150 °C for two hours |Formic acid, formates and other oxidizable substances | Not more than 1000 mg/kg expressed as formic acid |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 262 (i) SODIUM ACETATEDefinitionChemical name | Sodium acetate |Einecs | 204-823-8 |Chemical formula | C2H3NaO2·nH2O (n = 0 or 3) |Molecular weight | Anhydrous: | 82,03 |Trihydrate: | 136,08 |Assay | Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis |Description | Anhydrous: | White, odourless, granular, hygroscopic powder |Trihydrate: | Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air |IdentificationA.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 drying | Anhydrous: | Not more than 2 % (120 °C, 4 hours) |Trihydrate: | Between 36 and 42 % (120 °C, 4 hours) |Formic acid, formates and other oxidizable substances | Not more than 1000 mg/kg expressed as formic acid |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 262 (ii) SODIUM DIACETATEDefinition | Sodium diacetate is a molecular compound of sodium acetate and acetic acid |Chemical name | Sodium hydrogen diacetate |Einecs | 204-814-9 |Chemical formula | C4H7NaO4·nH2O (n = 0 or 3) |Molecular weight | 142,09 (anhydrous) |Assay | Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate |Description | White, hygroscopic crystalline solid with an acetic odour |IdentificationA.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 content | Not more than 2 % (Karl Fischer method) |Formic acid, formates and other oxidizable substances | Not more than 1000 mg/kg expressed as formic acid |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 263 CALCIUM ACETATEDefinitionChemical name | Calcium acetate |Einecs | 200-540-9 |Chemical formula | Anhydrous: | C4H6O4Ca |Monohydrate: | C4H6O4Ca·H2O |Molecular weight | Anhydrous: | 158,17 |Monohydrate: | 176,18 |Assay | Content not less than 98 % on the anhydrous basis |Description | Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder |IdentificationA.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 drying | Not more than 11 % after drying (155 °C to constant weight, for the monohydrate) |Water insoluble matter | Not more than 0,3 % |Formic acid, formates and other oxidizable substances | Not more than 1000 mg/kg expressed as formic acid |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 270 LACTIC ACIDDefinitionChemical name | Lactic acid 2-Hydroxypropionic acid 1-Hydroxyethane-1-carboxylic acid |Einecs | 200-018-0 |Chemical formula | C3H6O3 |Molecular weight | 90,08 |Assay | Content not less than 76 % and not more than 84 % |Description | Colourless or yellowish, nearly odourless, syrupy liquid with an acid taste, consisting of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically |Note:Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid | | |IdentificationA.Positive test for lactate | | |PuritySulphated ash | Not more than 0,1 % |Chloride | Not more than 0,2 % |Sulphate | Not more than 0,25 % |Iron | Not more than 10 mg/kg |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |Note:This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content | | |E 280 PROPIONIC ACIDDefinitionChemical name | Propionic acid Propanoic acid |Einecs | 201-176-3 |Chemical formula | C3H6O2 |Molecular weight | 74,08 |Assay | Content not less than 99,5 % |Description | Colourless or slightly yellowish, oily liquid with a slightly pungent odour |IndentificationA.Melting point | − 22 °C |B.Distillation range | 138,5 °C to 142,5 °C |PurityNon-volatile residue | Not more than 0,01 % when dried at 140 °C to constant weight |Aldehydes | Not more than 0,1 % expressed as formaldehyde |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 281 SODIUM PROPIONATEDefinitionChemical name | Sodium propionate Sodium propanoate |Einecs | 205-290-4 |Chemical formula | C3H5O2Na |Molecular weight | 96,06 |Assay | Content not less than 99 % after drying for two hours at 105 °C |Description | White crystalline hygroscopic powder, or a fine white powder |IdentificationA.Positive tests for propionate and for sodium | | |B.pH of a 10 % aqueous solution | Not less than 7,5 and not more than 10,5 |PurityLoss on drying | Not more than 4 % determined by drying for two hours at 105 °C |Water insolubles | Not more than 0,1 % |Iron | Not more than 50 mg/kg |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 282 CALCIUM PROPIONATEDefinitionChemical name | Calcium propionate |Einecs | 223-795-8 |Chemical formula | C6H10O4Ca |Molecular weight | 186,22 |Assay | Content not less than 99 %, after drying for two hours at 105 °C |Description | White crystalline powder |IdentificationA.Positive tests for propionate and for calcium | | |B.pH of a 10 % aqueous solution | Between 6,0 and 9,0 |PurityLoss on drying | Not more than 4 %, determined by drying for two hours at 105 °C |Water insolubles | Not more than 0,3 % |Iron | Not more than 50 mg/kg |Fluoride | Not more than 10 mg/kg |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 283 POTASSIUM PROPIONATEDefinitionChemical name | Potassium propionate Potassium propanoate |Einecs | 206-323-5 |Chemical formula | C3H5KO2 |Molecular weight | 112,17 |Assay | Content not less than 99 % after drying for two hours at 105 °C |Description | White crystalline powder |IdentificationA.Positive tests for propionate and for potassium | | |PurityLoss on drying | Not more than 4 %, determined by drying for two hours at 105 °C |Water-insoluble substances | Not more than 0,3 % |Iron | Not more than 30 mg/kg |Fluoride | Not more than 10 mg/kg |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 284 BORIC ACIDSynonyms | Boracic acid Orthoboric acid Borofax |DefinitionEinecs | 233-139-2 |Chemical formula | H3BO3 |Molecular weight | 61,84 |Assay | Content not less than 99,5 % |Description | Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite |IdentificationA.Melting point | At approximately 171 °C |B.Burns with a nice green flame | | |C.pH of a 3,3 % aqueous solution | Between 3,8 and 4,8 |PurityPeroxides | No colour develops with added KI-solution |Arsenic | Not more than 1 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 285 SODIUM TETRABORATE (BORAX)Synonyms | Sodium borate |DefinitionChemical name | Sodium tetraborate Sodium biborate Sodium pyroborate Anhydrous tetraborate |Einecs | 215-540-4 |Chemical formula | Na2B4O7 Na2B4O7·10H2O |Molecular weight | 201,27 |Description | Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water |IdentificationA.Melting range | Between 171 °C and 175 °C with decomposition |PurityPeroxides | No colour develops with added KI-solution |Arsenic | Not more than 1 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 290 CARBON DIOXIDESynonyms | Carbonic acid gas Dry ice (solid form) Carbonic anhydride |DefinitionChemical name | Carbon dioxide |Einecs | 204-696-9 |Chemical formula | CO2 |Molecular weight | 44,01 |Assay | Content not less than 99 % v/v on the gaseous basis |Description | A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurized cylinders or bulk storage systems, or in compressed solid blocks of dry ice. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders |IdentificationA. Precipitation (Precipitate formation) | When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid |PurityAcidity | 915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N) |Reducing substances, hydrogen phosphide and sulphide | 915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to which has been added 3 ml of ammonia must not cause clouding or blackening of this solution |Carbon monoxide | Not more than 10 μl/l |Oil content | Not more than 0,1 mg/l |E 300 ASCORBIC ACIDDefinitionChemical name | L-ascorbic acid Ascorbic acid 2,3-Didehydro-L-threo-hexono-1,4-lactone 3-Keto-L-gulofuranolactone |Einecs | 200-066-2 |Chemical formula | C6H8O6 |Molecular weight | 176,13 |Assay | Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6 |Description | White to pale yellow, odourless crystalline solid |IdentificationA.Melting range | Between 189 °C and 193 °C with decomposition |B.Positive tests for ascorbic acid | | |PurityLoss on drying | Not more than 0,4 % after drying in a vacuum desiccator over sulphuric acid for 24 hours |Sulphated ash | Not more than 0,1 % |Specific rotation | αD20 between + 20,5° and + 21,5° (10 % w/v aqueous solution) |pH of a 2 % aqueous solution | Between 2,4 and 2,8 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 301 SODIUM ASCORBATEDefinitionChemical name | Sodium ascorbate Sodium L-ascorbate 2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate 3-Keto-L-gulofurano-lactone sodium enolate |Einecs | 205-126-1 |Chemical formula | C6H7O6Na |Molecular weight | 198,11 |Assay | Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na |Description | White or almost white, odourless crystalline solid which darkens on exposure to light |IdentificationA.Positive tests for ascorbate and for sodium | | |PurityLoss on drying | Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours |Specific rotation | αD20 between + 103 ° and + 106 ° (10 % w/v aqueous solution) |pH of 10 % aqueous solution | Between 6,5 and 8,0 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 302 CALCIUM ASCORBATEDefinitionChemical name | Calcium ascorbate dihydrate Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate |Einecs | 227-261-5 |Chemical formula | C12H14O12Ca·2H2O |Molecular weight | 426,35 |Assay | Content not less than 98 % on a volatile matter-free basis |Description | White to slightly pale greyish-yellow odourless crystalline powder |IdentificationA.Positive tests for ascorbate and for calcium | | |PurityFluoride | Not more than 10 mg/kg (expressed as fluorine) |Specific rotation | αD20 between + 95 ° and + 97 ° (5 % w/v aqueous solution) |pH of 10 % aqueous solution | Between 6,0 and 7,5 |Volatile matter | Not more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 304 (i) ASCORBYL PALMITATEDefinitionChemical name | Ascorbyl palmitate L-ascorbyl palmitate 2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate 6-palmitoyl-3-keto-L-gulofuranolactone |Einecs | 205-305-4 |Chemical formula | C22H38O7 |Molecular weight | 414,55 |Assay | Content not less than 98 % on the dried basis |Description | White or yellowish-white solid with a citrus-like odour |IdentificationA.Melting range | Between 107 °C and 117 °C |PurityLoss on drying | Not more than 2,0 % after drying in a vacuum oven at 56 °C and 60 °C for one hour |Sulphated ash | Not more than 0,1 % |Specific rotation | αD20 between + 21 ° and + 24 ° (5 % w/v in methanol solution) |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 304 (ii) ASCORBYL STEARATEDefinitionChemical name | Ascorbyl stearate L-ascorbyl stearate 2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate 6-stearoyl-3-keto-L-gulofuranolactone |Einecs | 246-944-9 |Chemical formula | C24H42O7 |Molecular weight | 442,6 |Assay | Content not less than 98 % |Description | White or yellowish, white solid with a citrus-like odour |IdentificationA.Melting point | About 116 °C |PurityLoss on drying | Not more than 2,0 % after drying in a vacuum oven at 56 °C to 60 °C for one hour |Sulphated ash | Not more than 0,1 % |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 306 TOCOPHEROL-RICH EXTRACTDefinition | Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols Contains tocopherols such as d-α-, d-β-, d-γ- and d-ς-tocopherols |Molecular weight | 430,71 (d-α-tocopherol) |Assay | Content not less than 34 % of total tocopherols |Description | Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form |IdentificationA.By suitable gas liquid chromatographic method | | |B.Solubility tests | Insoluble in water. Soluble in ethanol. Miscible in ether |PuritySulphated ash | Not more than 0,1 % |Specific rotation | αD20 not less than + 20 ° |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 307 ALPHA-TOCOPHEROLSynonyms | dl-α-Tocopherol |DefinitionChemical name | dl-5,7,8-Trimethyltocol dl-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol |Einecs | 200-412-2 |Chemical formula | C29H50O2 |Molecular weight | 430,71 |Assay | Content not less than 96 % |Description | Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidizes and darkens on exposure to air or light |IdentificationA.Solubility tests | Insoluble in water, freely soluble in ethanol, miscible in ether |B.Spectrophotometry | In absolute ethanol the maximum absorption is about 292 nm |PurityRefractive index | n D20 1,503 — 1,507 |Specific absorption E 1 cm1 % in ethanol | E 1 cm1 %__NEWLINE__(292 nm) 72—76__NEWLINE__(0,01 g in 200 ml of absolute ethanol) |Sulphated ash | Not more than 0,1 % |Specific rotation | αD20 0° ± 0,05° (1 in 10 solution in chloroform) |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 308 GAMMA-TOCOPHEROLSynonyms | dl-γ-Tocopherol |DefinitionChemical name | 2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol |Einecs | 231-523-4 |Chemical formula | C28H48O2 |Molecular weight | 416,69 |Assay | Content not less than 97 % |Description | Clear, viscous, pale yellow oil which oxidizes and darkens on exposure to air or light |IdentificationA.Spectrometry | Maximum absorptions in absolute ethanol at about 298 nm and 257 nm |PuritySpecific absorption E 1 cm1 % in ethanol | E 1 cm1 % (298 nm) between 91 and 97 E 1 cm1 % (257 nm) between 5,0 and 8,0 |Refractive index | n D20 1,503—1,507 |Sulphated ash | Not more than 0,1 % |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 309 DELTA-TOCOPHEROLDefinitionChemical name | 2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol |Einecs | 204-299-0 |Chemical formula | C27H46O2 |Molecular weight | 402,7 |Assay | Content not less than 97 % |Description | Clear, viscous, pale yellowish or orange oil which oxidizes and darkens on exposure to air or light |IdentificationA.Spectrometry | Maximum absorptions in absolute ethanol at about 298 nm and 257 nm |PuritySpecific absorption E 1 cm1 % in ethanol | E 1 cm1 % (298 nm) between 89 and 95 E 1 cm1 % (257 nm) between 3,0 and 6,0 |Refractive index | n D20 1,500—1,504 |Sulphated ash | Not more than 0,1 % |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 310 PROPYL GALLATEDefinitionChemical name | Propyl gallate Propyl ester of gallic acid n-propyl ester of 3,4,5-trihydroxybenzoic acid |Einecs | 204-498-2 |Chemical formula | C10H12O5 |Molecular weight | 212,20 |Assay | Content not less than 98 % on the anhydrous basis |Description | White to creamy-white, crystalline, odourless solid |IdentificationA.Solubility tests | Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol |B.Melting range | Between 146 °C and 150 °C after drying at 110 °C for four hours |PurityLoss on drying | Not more than 1,0 % (110 °C, four hours) |Sulphated ash | Not more than 0,1 % |Free acid | Not more than 0,5 % (as gallic acid) |Chlorinated organic compound | Not more than 100 mg/kg (as C1) |Specific absorption E 1 cm1 % in ethanol | E 1 cm1 % (275 nm) not less than 485 and not more than 520 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 311 OCTYL GALLATEDefinitionChemical name | Octyl gallate Octyl ester of gallic acid n-octyl ester of 3,4,5-trihydroxybenzoic acid |Einecs | 213-853-0 |Chemical formula | C15H22O5 |Molecular weight | 282,34 |Assay | Content not less than 98 % after drying at 90 °C for six hours |Description | White to creamy-white odourless solid |IdentificationA.Solubility tests | Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol |B.Melting range | Between 99 °C and 102 °C after drying at 90 °C for six hours |PurityLoss on drying | Not more than 0,5 % (90 °C, six hours) |Sulphated ash | Not more than 0,05 % |Free acid | Not more than 0,5 % (as gallic acid) |Chlorinated organic compound | Not more than 100 mg/kg (as C1) |Specific absorption E 1 cm1 % in ethanol | E 1 cm1 % (275 nm) not less than 375 and not more than 390 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 312 DODECYL GALLATESynonyms | Lauryl gallate |DefinitionChemical name | Dodecyl gallate n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid Dodecyl ester of gallic acid |Einecs | 214-620-6 |Chemical formula | C19H30O5 |Molecular weight | 338,45 |Assay | Content not less than 98 % after drying at 90 °C for six hours |Description | White or creamy-white odourless solid |IdentificationA.Solubility tests | Insoluble in water, freely soluble in ethanol and ether |B.Melting range | Between 95 °C and 98 °C after drying at 90 °C for six hours |PurityLoss on drying | Not more than 0,5 % (90 °C, six hours) |Sulphated ash | Not more than 0,05 % |Free acid | Not more than 0,5 % (as gallic acid) |Chlorinated organic compound | Not more than 100 mg/kg (as Cl) |Specific absorption E 1 cm1 % in ethanol | E 1 cm1 % (275 nm) not less than 300 and not more than 325 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 10 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 30 mg/kg |E 315 ERYTHORBIC ACIDSynonyms | Isoascorbic acid D-araboascorbic acid |DefinitionChemical name | D-Erythro-hex-2-enoic acid γ-lactone Isoascorbic acid D-isoascorbic acid |Einecs | 201-928-0 |Chemical formula | C6H8O6 |Molecular weight | 176,13 |Assay | Content not less than 98 % on the anhydrous basis |Description | White to slightly yellow crystalline solid which darkens gradually on exposure to light |IdentificationA.Melting range | About 164 °C to 172 °C with decomposition |B.Positive test for ascorbic acid/colour reaction | | |PurityLoss on drying | Not more than 0,4 % after drying under reduced pressure on silica gel for 3 hours |Sulphated ash | Not more than 0,3 % |Specific rotation | αD25 10 % (w/v) aqueous solution between − 16,5° to − 18,0 ° |Oxalate | To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 316 SODIUM ERYTHORBATESynonyms | Sodium isoascorbate |DefinitionChemical name | Sodium isoascorbate Sodium D-isoascorbic acid Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone 3-keto-D-gulofurano-lactone sodium enolate monohydrate |Einecs | 228-973-9 |Chemical formula | C6H7O6Na·H2O |Molecular weight | 216,13 |Assay | Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis |Description | White crystalline solid |IdentificationA.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 drying | Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours |Specific rotation | αD25 10 % (w/v) aqueous solution between + 95 ° and + 98 ° |pH of a 10 % aqueous solution | 5,5 to 8,0 |Oxalate | To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 320 BUTYLATED HYDROXYANISOLE (BHA)Synonyms | BHA |DefinitionChemical name | 3-Tertiary-butyl-4-hydroxyanisole A mixture of 2-tertiarybutyl-4-hydroxyanisole and 3-tertiarybutyl-4-hydroxyanisole |Einecs | 246-563-8 |Chemical formula | C11H16O2 |Molecular weight | 180,25 |Assay | Content not less than 98,5 % of C11H16O2 and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer |Description | White or slightly yellow crystals or waxy solid with a slight aromatic smell |IdentificationA.Solubility tests | Insoluble in water |B.Melting range | Between 48 °C and 55 °C |PuritySulphated ash | Not more than 0,05 % after calcination at 800 ± 25 °C |Phenolic impurities | Not more than 0,5 % |Specific absorption E 1 cm1 % in ethanol | E 1 cm1 % (290 nm) not less than 190 and not more than 210 |E 1 cm1 % (228 nm) not less than 326 and not more than 345 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 321 BUTYLATED HYDROXYTOLUENE (BHT)Synonyms | BHT |DefinitionChemical name | 2,6-Ditertiary-butyl-p-cresol 4-Methyl-2,6-ditertiarybutylphenol |Einecs | 204-881-4 |Chemical formula | C15H24O |Molecular weight | 220,36 |Assay | Content not less than 99 % |Description | White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour |IdentificationA.Solubility tests | Insoluble in water and propane- 1,2-diol Freely soluble in ethanol |B.Melting point | At 70 °C |C.Absorbance maximum | The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100000 solution in dehydrated ethanol exhibits a maximum only at 278 nm |PuritySulphated ash | Not more than 0,005 % |Phenolic impurities | Not more than 0,5 % |Specific absorption E 1 cm1 % in ethanol | E 1 cm1 % (278 nm) not less than 81 and not more than 88 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 322 LECITHINSSynonyms | Phosphatides Phospholipids |Definition | Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides |Einecs | 232-307-2 |Assay | Lecithins: not less than 60,0 % of substances insoluble in acetoneHydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone |Description | Lecithins: brown liquid or viscous semi-liquid or powderHydrolysed lecithins: light brown to brown viscous liquid or paste |IdentificationA.Positive tests for choline, for phosphorus and fatty acids | | |B.Test for hydrolysed lecithin | To a 800 ml beaker add 500 ml of water (30 °C—35 °C). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g |PurityLoss on drying | Not more than 2,0 % determined by drying at 105 °C for one hour |Toluene-insoluble matter | Not more than 0,3 % |Acid value | Lecithins: not more than 35 mg of potassium hydroxide per gramHydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram |Peroxide value | Equal to or less than 10 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 325 SODIUM LACTATEDefinitionChemical name | Sodium lactate Sodium 2-hydroxypropanoate |Einecs | 200-772-0 |Chemical formula | C3H5NaO3 |Molecular weight | 112,06 (anhydrous) |Assay | Content not less than 57 % and not more than 66 % |Description | Colourless, transparent, liquid Odourless, or with a slight, characteristic odour |IdentificationA.Positive test for lactate | | |B.Positive test for potassium | | |PurityAcidity | Not more than 0,5 % after drying expressed as lactic acid |pH of a 20 % aqueous solution | 6,5 to 7,5 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |Reducing substances | No reduction of Fehling's solution |Note:This specification refers to a 60 % aqueous solution | | |E 326 POTASSIUM LACTATEDefinitionCheminal name | Potassium lactate Potassium 2-hydroxypropanoate |Einecs | 213-631-3 |Chemical formula | C3H5O3K |Molecular weight | 128,17 (anhydrous) |Assay | Content not less than 57 % and not more than 66 % |Description | Slightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour |IdentificationA.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 | | |PurityArsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |Acidity | Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required |Reducing substances | Potassium lactate solution shall not cause any reduction of Fehling's solution |Note:This specification refers to a 60 % aqueous solution | | |E 327 CALCIUM LACTATEDefinitionChemical name | Calcium dilactate Calcium dilactate hydrate 2-Hydroxypropanoic acid calcium salt |Einecs | 212-406-7 |Chemical formula | (C3H5O2)2 Ca·nH2O (n = 0—5) |Molecular weight | 218,22 (anhydrous) |Assay | Content not less than 98 % on the anhydrous basis |Description | Almost odourless, white crystalline powder or granules |IdentificationA.Positive tests for lactate and for calcium | | |B.Solubility tests | Soluble in water and practically insoluble in ethanol |PurityLoss on drying | Determined by drying at 120 °C for four hours: anhydrous: not more than 3,0 %with 1 molecule of water: not more than 8,0 %with 3 molecules of water: not more than 20,0 %with 4,5 molecules of water: not more than 27,0 % |Acidity | Not more than 0,5 % of the dry matter expressed as lactic acid |Fluoride | Not more than 30 mg/kg (expressed as fluorine) |pH of a 5 % solution | Between 6,0 and 8,0 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |Reducing substances | No reduction of Fehling's solution |E 330 CITRIC ACIDDefinitionChemical name | Citric acid 2-Hydroxy-1,2,3-propanetricarboxylic acid β-Hydroxytricarballytic acid |Einecs | 201-069-1 |Chemical formula | (a)C6H8O7 (anhydrous)(b)C6H8O7·H2O (monohydrate) |Molecular weight | (a)192,13 (anhydrous)(b)210,15 (monohydrate) |Assay | Citric acid may be anhydrous or it may contain 1 molecule of water. Citric acid contains not less than 99,5 % of C6H8O7, calculated on the anhydrous basis |Description | Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air |IdentificationA.Solubility tests | Very soluble in water; freely soluble in ethanol; soluble in ether |PurityWater content | Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method) |Sulphated ash | Not more than 0,05 % after calcination at 800 ± 25 °C |Arsenic | Not more than 1 mg/kg |Lead | Not more than 1 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 5 mg/kg |Oxalates | Not more than 100 mg/kg, expressed as oxalic acid, after drying |Readily carbonizable substances | Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 °C in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K) |E 331 (i) MONOSODIUM CITRATESynonyms | Monosodium citrate Monobasic sodium citrate |DefinitionChemical name | Monosodium citrate Monosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid |Chemical formula | (a)C6H7O7Na (anhydrous)(b)C6H7O7Na·H2O (monohydrate) |Molecular weight | (a)214,11 (anhydrous)(b)232,23 (monohydrate) |Assay | Content not less than 99 % on the anhydrous basis |Description | Crystalline white powder or colourless crystals |IdentificationA.Positive tests for citrate and for sodium | | |PurityLoss on drying | Determined by drying at 180 °C for four hours: anhydrous: not more than 1,0 %monohydrate: not more than 8,8 % |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |pH of a 1 % aqueous solution | Between 3,5 and 3,8 |Arsenic | Not more than 1 mg/kg |Lead | Not more than 1 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 5 mg/kg |E 331 (ii) DISODIUM CITRATESynonyms | Disodium citrate Dibasic sodium citrate |DefinitionChemical name | Disodium citrate Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Disodium salt of citric acid with 1,5 molecules of water |Einecs | 205-623-3 |Chemical formula | C6H6O7Na2·1,5H2O |Molecular weight | 263,11 |Assay | Content not less than 99 % on the anhydrous basis |Description | Crystalline white powder or colourless crystals |IdentificationA.Positive tests for citrate and for sodium | | |PurityLoss on drying | Not more than 13,0 % by drying at 180 °C for four hours |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |pH of a 1 % aqueous solution | Between 4,9 and 5,2 |Arsenic | Not more than 1 mg/kg |Lead | Not more than 1 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 5 mg/kg |E 331 (iii) TRISODIUM CITRATESynonyms | Trisodium citrate Tribasic sodium citrate |DefinitionChemical name | Trisodium citrate Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form |Einecs | 200-675-3 |Chemical formula | Anhydrous: | C6H5O7Na3 |Hydrated: | C6H5O7Na3·nH2O (n = 2 or 5) |Molecular weight | 258,07 (anhydrous) |Assay | Not less than 99 % on the anhydrous basis |Description | Crystalline white powder or colourless crystals |IdentificationA.Positive tests for citrate and for sodium | | |PurityLoss on drying | Determined by drying at 180 °C for four hours: |— anhydrous: | not more than 1,0 % |— dihydrate: | not more than 13,5 % |— pentahydrate: | not more than 30,3 % |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |pH of a 5 % aqueous solution | Between 7,5 and 9,0 |Arsenic | Not more than 1 mg/kg |Lead | Not more than 1 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 5 mg/kg |E 332 (i) MONOPOTASSIUM CITRATESynonyms | Monopotassium citrate Monobasic potassium citrate |DefinitionChemical name | Monopotassium citrate Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Anhydrous monopotassium salt of citric acid |Einecs | 212-753-4 |Chemical formula | C6H7O7K |Molecular weight | 230,21 |Assay | Content not less than 99 % on the anhydrous basis |Description | White, hygroscopic, granular powder or transparent crystals |IdentificationA.Positive tests for citrate and for potassium | | |PurityLoss on drying | Not more than 1,0 % determined by drying at 180 °C for four hours |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |pH of a 1 % aqueous solution | Between 3,5 and 3,8 |Arsenic | Not more than 1 mg/kg |Lead | Not more than 1 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 5 mg/kg |E 332 (ii) TRIPOTASSIUM CITRATESynonyms | Tripotassium citrate Tribasic potassium citrate |DefinitionChemical name | Tripotassium citrate Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Monohydrated tripotassium salt of citric acid |Einecs | 212-755-5 |Chemical formula | C6H5O7K3·H2O |Molecular weight | 324,42 |Assay | Content not less than 99 % on the anhydrous basis |Description | White, hygroscopic, granular powder or transparent crystals |IdentificationA.Positive tests for citrate and for potassium | | |PurityLoss on drying | Not more than 6,0 % determined by drying at 180 °C for four hours |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |pH of a 5 % aqueous solution | Between 7,5 and 9,0 |Arsenic | Not more than 1 mg/kg |Lead | Not more than 1 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 5 mg/kg |E 333 (i) MONOCALCIUM CITRATESynonyms | Monocalcium citrate Monobasic calcium citrate |DefinitionChemical name | Monocalcium citrate Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Monohydrate monocalcium salt of citric acid |Chemical formula | (C6H7O7)2Ca·H2O |Molecular weight | 440,32 |Assay | Content not less than 97,5 % on the anhydrous basis |Description | Fine white powder |IdentificationA.Positive tests for citrate and for calcium | | |PurityLoss on drying | Not more than 7,0 % determined by drying at 180 °C for four hours |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |pH of a 1 % aqueous solution | Between 3,2 and 3,5 |Fluoride | Not more than 30 mg/kg (expressed as fluorine) |Arsenic | Not more than 1 mg/kg |Lead | Not more than 1 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 5 mg/kg |Carbonates | Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles |E 333 (ii) DICALCIUM CITRATESynonyms | Dicalcium citrate Dibasic calcium citrate |DefinitionChemical name | Dicalcium citrate Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Trihydrated dicalcium salt of citric acid |Chemical formula | (C6H7O7)2Ca2·3H2O |Molecular weight | 530,42 |Assay | Not less than 97,5 % on the anhydrous basis |Description | Fine white powder |IdentificationA.Positive tests for citrate and for calcium | | |PurityLoss on drying | Not more than 20,0 % determined by drying at 180 °C for four hours |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |Fluoride | Not more than 30 mg/kg (expressed as fluorine) |Arsenic | Not more than 1 mg/kg |Lead | Not more than 1 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 5 mg/kg |Carbonates | Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles |E 333 (iii) TRICALCIUM CITRATESynonyms | Tricalcium citrate Tribasic calcium citrate |DefinitionChemical name | Tricalcium citrate Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Tetrahydrated tricalcium salt of citric acid |Einecs | 212-391-7 |Chemical formula | (C6H6O7)2Ca3·4H2O |Molecular weight | 570,51 |Assay | Not less than 97,5 % on the anhydrous basis |Description | Fine white powder |IdentificationA.Positive tests for citrate and for calcium | | |PurityLoss on drying | Not more than 14,0 % determined by drying at 180 °C for four hours |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |Fluoride | Not more than 30 mg/kg (expressed as fluorine) |Arsenic | Not more than 1 mg/kg |Lead | Not more than 1 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 5 mg/kg |Carbonates | Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles |E 334 L(+)-TARTARIC ACIDDefinitionChemical name | L-tartaric acid L-2,3-dihydroxybutanedioic acid d-α,β-dihydroxysuccinic acid |Einecs | 201-766-0 |Chemical formula | C4H6O6 |Molecular weight | 150,09 |Assay | Content not less than 99,5 % on the anhydrous basis |Description | Colourless or translucent crystalline solid or white crystalline powder |IdentificationA.Melting range | Between 168 °C and 170 °C |B.Positive test for tartrate | | |PurityLoss on drying | Not more than 0,5 % (over P2O5, three hours) |Sulphated ash | Not more than 1000 mg/kg after calcination at 800 ± 25 °C |Specific optical rotation of a 20 % w/v aqueous solution | αD20 between + 11,5° and + 13,5 ° |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |E 335 (i) MONOSODIUM TARTRATESynonyms | Monosodium salt of L-(+)-tartaric acid |DefinitionChemical name | Monosodium salt of L-2,3-dihydroxybutanedioic acid Monohydrated monosodium salt of L-(+)-tartaric acid |Chemical formula | C4H5O6Na·H2O |Molecular weight | 194,05 |Assay | Content not less than 99 % on the anhydrous basis |Description | Transparent colourless crystals |IdentificationA.Positive tests for tartrate and for sodium | | |PurityLoss on drying | Not more than 10,0 % determined by drying at 105 °C for four hours |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 335 (ii) DISODIUM TARTRATEDefinitionChemical name | Disodium L-tartrate Disodium (+)-tartrate Disodium (+)-2,3-dihydroxybutanedioic acid Dihydrated disodium salt of L-(+)-tartaric acid |Einecs | 212-773-3 |Chemical formula | C4H4O6Na2·2H2O |Molecular weight | 230,8 |Assay | Content not less than 99 % on the anhydrous basis |Description | Transparent, colourless crystals |IdentificationA.Positive tests for tartrate and for sodium | | |B.Solubility tests | 1 gram is insoluble in 3 ml of water. Insoluble in ethanol |PurityLoss on drying | Not more than 17,0 % determined by drying at 150 °C for four hours |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |pH of a 1 % aqueous solution | Between 7,0 and 7,5 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 336 (i) MONOPOTASSIUM TARTRATESynonyms | Monobasic potassium tartrate |DefinitionChemical name | Anhydrous monopotassium salt of L-(+)-tartaric acid Monopotassium salt of L-2,3-dihydroxybutanedioic acid |Chemical formula | C4H5O6K |Molecular weight | 188,16 |Assay | Content not less than 98 % on the anhydrous basis |Description | White crystalline or granulated powder |IdentificationA.Positive tests for tartrate and for potassium | | |B.Melting point | 230 °C |PuritypH of a 1 % aqueous solution | 3,4 |Loss on drying | Not more than 1,0 % determined by drying at 105 °C for four hours |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 336 (ii) DIPOTASSIUM TARTRATESynonyms | Dibasic potassium tartrate |DefinitionChemical name | Dipotassium salt of L-2,3-dihydroxybutanedioic acid Dipotassium salt with half a molecule of water of L-(+)-tartaric acid |Einecs | 213-067-8 |Chemical formula | C4H4O6K2·½H2O |Molecular weight | 235,2 |Assay | Content not less than 99 % on the anhydrous basis |Description | White crystalline or granulated powder |IdentificationA.Positive tests for tartrate and for potassium | | |PuritypH of a 1 % aqueous solution | Between 7,0 and 9,0 |Loss on drying | Not more than 4,0 % determined by drying at 150 °C for four hours |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 337 POTASSIUM SODIUM TARTRATESynonyms | Potassium sodium L-(+)-tartrate Rochelle salt Seignette salt |DefinitionChemical name | Potassium sodium salt of L-2,3-dihydroxybutanedioic acid Potassium sodium L-(+)-tartrate |Einecs | 206-156-8 |Chemical formula | C4H4O6KNa·4H2O |Molecular weight | 282,23 |Assay | Content not less than 99 % on the anhydrous basis |Description | Colourless crystals or white crystalline powder |IdentificationA.Positive tests for tartrate, for potassium and for sodium | | |B.Solubility tests | 1 gram is soluble in 1 ml of water, insoluble in ethanol |C.Melting range | Between 70 and 80 °C |PurityLoss on drying | Not more than 26,0 % and not less than 21,0 % determined by drying at 150 °C for three hours |Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying |pH of 1 % aqueous solution | Between 6,5 and 8,5 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 338 PHOSPHORIC ACIDSynonyms | Orthophosphoric acid Monophosphoric acid |DefinitionChemical name | Phosphoric acid |Einecs | 231-633-2 |Chemical formula | H3PO4 |Molecular weight | 98,00 |Assay | Content not less than 71 % and not more than 83 % |Description | Clear, colourless, viscous liquid |IdentificationA.Positive tests for acid and for phosphate | | |PurityVolatile acids | Not more than 10 mg/kg (as acetic acid) |Chlorides | Not more than 200 mg/kg (expressed as chlorine) |Nitrates | Not more than 5 mg/kg (as NaNO3) |Sulphates | Not more than 1500 mg/kg (as CaSO4) |Fluoride | Not more than 10 mg/kg (expressed as fluorine) |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |Note:This specification refers to a 75 % aqueous solution | | |E 339 (i) MONOSODIUM PHOSPHATESynonyms | Monosodium monophosphate Acid monosodium monophosphate Monosodium orthophosphate Monobasic sodium phosphate |DefinitionChemical name | Sodium dihydrogen monophosphate |Einecs | 231-449-2 |Chemical formula | Anhydrous: | NaH2PO4 |Monohydrate: | NaH2PO4·H2O |Dihydrate: | NaH2PO4·2H2O |Molecular weight | Anhydrous: | 119,98 |Monohydrate: | 138,00 |Dihydrate: | 156,01 |Assay | After drying at 6,0 °C for one hour and then at 105 °C for four hours, contains not less than 97 % of NaH2PO4 |Description | A white odourless, slightly deliquescent powder, crystals or granules |IdentificationA.Positive tests for sodium and for phosphate | | |B.Solubility tests | Freely soluble in water. Insoluble in ethanol, ether or chloroform |C.P2O5 content | Between 58,0% and 60,0% |PurityLoss on drying | The anhydrous salt loses no more than 2,0 %, the monohydrate no more than 15,0 %, and the dihydrate no more than 25 % when dried first at 60 °C for one hour, then at 105 °C for four hours |Water-insoluble substances | Not more than 0,2 % on the anhydrous basis |Fluoride | Not more than 10 mg/kg (expressed as fluorine) |pH of a 1 % aqueous solution | Between 4,1 and 5,0 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 339 (ii) DISODIUM PHOSPHATESynonyms | Disodium monophosphate Secondary sodium phosphate Disodium orthophosphate Acid disodium phosphate |DefinitionChemical name | Disodium hydrogen monophosphate Disodium hydrogen orthophosphate |Einecs | 231-448-7 |Chemical formula | Anhydrous: | Na2HPO4 |Hydrated: | Na2HPO4·nH2O (n = 2, 7 or 12) |Molecular weight | 141,98 (anhydrous) |Assay | After drying at 40 °C for three hours and subsequently at 105 °C for five hours, contains not less than 98 % of Na2HPO4 |Description | Anhydrous disodium hydrogen phosphate is a white, hygroscopic, odourless powder. Hydrated forms available include the dihydrate: a white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals |IdentificationA.Positive tests for sodium and for phosphate | | |B.Solubility tests | Freely soluble in water. Insoluble in ethanol |C.P2O5 content | Between 49 % and 51 % (anhydrous) |PurityLoss on drying | When dried at 40 °C for three hours and then at 105 °C for five hours, the losses in weight are as follows: anhydrous not more than 5,0 %, dihydrate not more than 22,0 %, heptahydrate not more than 50,0 %, dodecahydrate not more than 61,0 % |Water-insoluble substances | Not more than 0,2 % on the anhydrous basis |Fluoride | Not more than 10 mg/kg (expressed as fluorine) |pH of a 1,0 % aqueous solution | Between 8,4 and 9,6 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 339 (iii) TRISODIUM PHOSPHATESynonyms | Sodium phosphate Tribasic sodium phosphate Trisodium orthophosphate |DefinitionChemical name | Trisodium monophosphate Trisodium phosphate Trisodium orthophosphate |Einecs | 231-509-8 |Chemical formula | Anhydrous: | Na3PO4 |Hydrated: | Na3PO4·nH2O (n = 0,5, 1 or 12) |Molecular weight | 163,94 (anhydrous) |Assay | Sodium phosphate anhydrous, and also the hemi- and monohydrates, contains not less than 97,0 % of Na3PO4, calculated on the dried basis. Sodium phosphate dodecahydrate contains not less than 92,0 % of Na3PO4, calculated on the ignited basis |Description | White odourless crystals, granules or a crystalline powder. Hydrated forms available include hemi- and monohydrates, hexahydrate, octahydrate, decahydrate and dodecahydrate. The dodecahydrate contains ¼ molecule of sodium hydroxide |IdentificationA.Positive tests for sodium and for phosphate | | |B.Solubility tests | Freely soluble in water. Insoluble in ethanol |C.P2O5 content | Between 40,5 % and 43,5 % (anhydrous) |PurityLoss on ignition | When dried at 120 °C for two hours and then ignited at about 800 °C for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate: not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 % |Water-insoluble substances | Not more than 0,2 % on the anhydrous basis |Fluoride | Not more than 10 mg/kg (expressed as fluorine) |pH of a 1,0 % aqueous solution | Between 11,5 and 12,5 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 340 (i) MONOPOTASSIUM PHOSPHATESynonyms | Monobasic potassium phosphate Monopotassium monophosphate Potassium acid phosphate Potassium orthophosphate |DefinitionChemical name | Potassium dihydrogen phosphate Monopotassium dihydrogen orthophosphate Monopotassium dihydrogen monophosphate |Einecs | 231-913-4 |Chemical formula | KH2PO4 |Molecular weight | 136,09 |Assay | Content not less than 98,0 % after drying at 105 °C for four hours |Description | Odourless, colourless crystals or white granular or crystalline powder, hygroscopic |IdentificationA.Positive tests for potassium and for phosphate | | |B.Solubility tests | Freely soluble in water. Insoluble in ethanol |C.P2O5 content | Between 51,0 % and 53,0 % |PurityLoss on drying | Not more than 2,0 % determined by drying at 105 °C for four hours |Water-insoluble substances | Not more than 0,2 % on the anhydrous basis |Fluoride | Not more than 10 mg/kg (expressed as fluorine) |pH of a 1 % aqueous solution | Between 4,2 and 4,8 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 340 (ii) DIPOTASSIUM PHOSPHATESynonyms | Dipotassium monophosphate Secondary potassium phosphate Dipotassium acid phosphate Dipotassium orthophosphate Dibasic potassium phosphate |DefinitionChemical name | Dipotassium hydrogen monophosphate Dipotassium hydrogen phosphate Dipotassium hydrogen orthophosphate |Einecs | 231-834-5 |Chemical formula | K2HPO4 |Molecular weight | 174,18 |Assay | Content not less than 98 % after drying at 105 °C for four hours |Description | Colourless or white granular powder, crystals or masses; deliquescent substance |IdentificationA.Positive tests for potassium and for phosphate | | |B.Solubility tests | Freely soluble in water. Insoluble in ethanol |C.P2O5 content | Between 40,3 % and 41,5 % |PurityLoss on drying | Not more than 2,0 % determined by drying at 105 °C for four hours |Water-insoluble substances | Not more than 0,2 % on the anhydrous basis |Fluoride | Not more than 10 mg/kg (expressed as fluorine) |pH of a 1 % aqueous solution | Between 8,7 and 9,4 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 340 (iii) TRIPOTASSIUM PHOSPHATESynonyms | Potassium phosphate Tribasic potassium phosphate Tripotassium orthophosphate |DefinitionChemical name | Tripotassium monophosphate Tripotassium phosphate Tripotassium orthophosphate |Einecs | 231-907-1 |Chemical formula | Anhydrous: | K3PO4 |Hydrated: | K3PO4·nH2O (n = 1 or 3) |Molecular weight | 212,27 (anhydrous) |Assay | Content not less than 97 % calculated on the ignited basis |Description | Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate |IdentificationA.Positive tests for potassium and for phosphate | | |B.Solubility tests | Freely soluble in water. Insoluble in ethanol |C.P2O5 content | Between 30,5 % and 33,0 % (anhydrous on ignited basis) |PurityLoss on ignition | Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %. Determined by drying at 105 °C for one hour and then ignite at about 800 °C ± 25 °C for 30 minutes |Water-insoluble substances | Not more than 0,2 % on the anhydrous basis |Fluoride | Not more than 10 mg/kg (expressed as fluorine) |pH of a 1 % aqueous solution | Between 11,5 and 12,3 |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 341 (i) MONOCALCIUM PHOSPHATESynonyms | Monobasic calcium phosphate Monocalcium orthophosphate |DefinitionChemical name | Calcium dihydrogen phosphate |Einecs | 231-837-1 |Chemical formula | Anhydrous: | Ca(H2PO4)2 |Monohydrate: | Ca(H2PO4)2·H2O |Molecular weight | 234,05 (anhydrous) 252,08 (monohydrate) |Assay | Content not less than 95 % on the dried basis |Description | Granular powder or white, deliquescent crystals or granules |IdentificationA.Positive tests for calcium and for phosphate | | |B.P2O5 content | Between 55,5 % and 61,1 % (anhydrous) |C.CaO content | Between 23,0 % and 27,5 % (anhydrous) Between 19,0 % and 24,8 % (monohydrate) |PurityLoss on drying | Not less than 14 % determined by drying at 105 °C for four hours (anhydrous) Not more than 17,5 % determined by drying at 60 °C for one hour, then at 105 °C for four hours (monohydrate) |Loss on ignition | Not more than 17,5 % after ignition at 800 °C ± 25 °C for 30 minutes (anhydrous) Not more than 25,0 % determined by drying at 105 °C for one hour, then ignite at 800 °C ± 25 °C for 30 minutes (monohydrate) |Fluoride | Not more than 30 mg/kg (expressed as fluorine) |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 341 (ii) DICALCIUM PHOSPHATESynonyms | Dibasic calcium phosphate Dicalcium orthophosphate |DefinitionChemical name | Calcium monohydrogen phosphate Calcium hydrogen orthophosphate Secondary calcium phosphate |Einecs | 231-826-1 |Chemical formula | Anhydrous: | CaHPO4 |Dihydrate: | CaHPO4·2H2O |Molecular weight | 136,06 (anhydrous) 172,09 (dihydrate) |Assay | Dicalcium phosphate, after drying at 200 °C for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4 |Description | White crystals or granules, granular powder or powder |IdentificationA.Positive tests for calcium and for phosphate | | |B.Solubility tests | Sparingly soluble in water. Insoluble in ethanol |C.P2O5 content | Between 50,0 % and 52,5 % (anhydrous) |PurityLoss on ignition | Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 °C ± 25 °C for 30 minutes |Fluoride | Not more than 50 mg/kg |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 341 (iii) TRICALCIUM PHOSPHATESynonyms | Calcium phosphate, tribasic Calcium orthophosphate |DefinitionChemical name | Tricalcium monophosphate |Einecs | 231-840-8 |Chemical formula | Ca3(PO4)2 |Molecular weight | 310,17 |Assay | Not less than 90 % calculated on the ignited basis |Description | A white, odourless and tasteless powder which is stable in air |IdentificationA.Positive tests for calcium and for phosphate | | |B.Solubility tests | Practically insoluble in water; insoluble in ethanol, soluble in dilute hydrochloric and nitric acid |C.P2O5 content | Between 38,5 % and 48,0 % (anhydrous) |PurityLoss on ignition | Not more than 8 % after ignition at 800 °C ± 25 °C, to constant weight |Fluoride | Not more than 50 mg/kg (expressed as fluorine) |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATESynonyms | Calcium disodium EDTA Calcium disodium edetate |DefinitionChemical name | N,N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]calciate(2)-disodium Calcium disodium ethylenediaminetetra acetate Calcium disodium (ethylenedinitrilo)tetra acetate |Einecs | 200-529-9 |Chemical formula | C10H12O8CaN2Na2·2H2O |Molecular weight | 410,31 |Assay | Content not less than 97 % on the anhydrous basis |Description | White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic |IdentificationA.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 content | 5 to 13 % (Karl Fischer method) |Arsenic | Not more than 3 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |E 1105 LYSOZYMESynonyms | Lysozyme hydrochloride Muramidase |Definition | Lysozyme 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 hydrochloride |Chemical name | Enzyme Commission (EC) No: 3.2.1.17 |Einecs | 232-620-4 |Molecular weight | About 14000 |Assay | Content not less than 950 mg/g on the anhydrous basis |Description | White, odourless powder having a slightly sweet taste |IdentificationA.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 content | Not more than 6,0 % (Karl Fischer method) (powder form only) |Residue on ignition | Not more than 1,5 % |Nitrogen | Not less than 16,8 % and not more than 17,8 % |Arsenic | Not more than 1 mg/kg |Lead | Not more than 5 mg/kg |Mercury | Not more than 1 mg/kg |Heavy metals (as Pb) | Not more than 10 mg/kg |Microbiological criteriaTotal bacterial count | Not more than 5 × 104 col/g |Salmonellae | Absent in 25 g |Staphylococcus aureus | Absent in 1 g |Escherichia coli | Absent in 1 g |--------------------------------------------------