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

eurovoc_concepts:
approximation of laws
consumer protection
food additive
foodstuffs legislation
human nutrition

text: 50 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 31996L0077 30. 12. 1996 IL-ĠURNAL UFFIĊJALI TAL-KOMUNITAJIET EWROPEJ L 339/1 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-ħlewwa (Test b’rilevanza għaż-ŻEE) IL-KUMMISSJONI TAL-KOMUNITAJIET EWROPEJ, Wara li kkunsidrat it-Trattat li jistabbilixxi l-Komunità Ewropea, Billi huwa meħtieġ li tittieħed konsiderazzjoni tal-ispeċifikaz- zjonijiet u t-tekniki analitiċi għall-addittivi kif stabbiliti fil-Codex Alimentarius kif abbozzati mill-Kumitat Konġunt l-Esperti tal-FAO/WHO dwar l-Additivi ta’ l-Ikel (Jecfa); ta’ Wara li kkunsidrat id-Direttiva tal-Kunsill 89/107/KEE tal-21 ta’ Diċembru 1988 dwar l-approssimazzjoni tal-Istati l-ikel awtorizzati għall- Membri 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, jirrigwardaw l-addittivi ma’ tal-liġijiet li 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-ħlew- wa 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 tistab- l-kriterja speċifika tal-purità għall-preservattivi awtoriz- bilixxi zati għall-użu fl-ikel l-aħħar emendata bid-Direttiva 86/604/KEE (5); intiż għal konsum uman (4), kif Billi huwa meħtieġ li jinbidlu il-kriterji tal-purita stabbiliti fid- Direttiva tal-Kunsill 78/664/KEE tas-25 ta’ Lulju 1978 li tistab- jistgħu l-kriterji speċifiċi tal-purità għal antiossidanti bilixxi jintużaw fl-ikel intiż għal konsum uman (6), kif l-aħħar emen- data bid-Direttiva 82/712/KEE (7); li Billi d-Direttivi 65/66/KEE u 78/664/KEE għandhom ikunu mħassra kif xieraq; l-ikel, l-addittivi ta’ jew materjali jekk imħejjija b’metodi ta’ preparaz- Billi tal-bidu sinifikantament differenti minn zjoni tal-Kumitat Xjentifiku ta’ dawk inklużi 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 l-valutazzjoni sħiħa b’enfasi fuq il-kriterji tal-purità; fl-evalwazzjoni ta’ Billi l-miżuri li hemm disposizzjoniji dwarhom f’din id-Diretti- va huma bi qbil ma l-opinjoni tal-Kumitat Permanenti dwar l- oġġetti ta’ l-ikel, ADOTTAT DIN ID-DIRETTIVA: L-Artikolu 1 Il-kriterji tal-purità msemmija fl-Artikolu 3(3)(a) tad-Direttiva 89/107/KEE għall-addittivi l-ikel apparti mill-kuluri u s- sustanzi fid-Direttiva 95/2/KE, huma stabbiliti fl-Anness ma’ din. jagħtu l-ħlewwa, kif imsemmija ta’ li (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-Artikolu 2 Id-Direttivi 65/66/KEE u 78/664/KEE huma b’hekk imħassra. 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 51 L-Artikolu 3 L-Istati Membri għandhom idaħħlu fis-seħħ il-liġijiet, 1. ir- regolamenti u d-dispożizzjonijiet amministrativi meħtieġa sa- biex 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 għand- hom ikunu akkumpanjati b’din ir-referenza fil-waqt tal-pubbli- Il-proċedura għal din ir-referenza kazzjoni uffiċjali għandha tkun adottata mill-Istati Membri. tagħhom. Il-prodotti mqiegħda fis-suq jew ittikkettjati qabel l-1 ta’ 2. Lulju 1997 li ma jkunux konformi ma din id-Direttiva jistgħu jkunu kummerċjalizzati sa kemm il-ħażniet ikunu eżawriti. L-Artikolu 4 Din id-Direttiva għandha tidħol fis-seħħ fil-20 jum li jiġi wara dak tal-pubblikazzjoni tagħha fil-Ġurnal Uffiċjali tal-Komunitajiet Ewropej. L-Artikolu 5 Din id-Direttiva hija indirizzata lill-Istati Membri. Magħmula fi Brussel, fit-2 ta’ Diċembru 1996. Għall-Kummissjoni Martin BANGEMANN Membru tal-Kummissjoni 52 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 E 200 SORBIC ACID Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Melting range B. Spectrometry L-ANNESSI Sorbic acid Trans, trans‐2,4‐hexadienoic acid 203‐768‐7 C6H8O2 112,12 Content not less than 99 % on the anhydrous basis 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 Between 133 °C and 135 °C, after vacuum drying for four hours in a sulphuric acid desiccator An isopropanol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm C. Positive test for double bonds D. Sublimation point 80 °C Purity Water content Sulphated ash Aldehydes Arsenic Lead Mercury Not more than 0,5 % (Karl Fischer method) Not more than 0,2 % Not more than 0,1 % (as formaldehyde) Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 202 POTASSIUM SORBATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Potassium sorbate Potassium (E,E)‐2,4‐hexadienoate Potassium salt of trans, trans 2,4‐hexadienoic acid 246‐376‐1 C6H7O2K 150,22 Content not less than 99 % on the dried basis White crystalline powder showing no change in colour after heating for 90 minutes at 105 °C 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 53 Identification A. Melting range of sorbic acid isolated by acidification recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator and not B. Positive tests double bonds for potassium and for Purity Loss on drying Acidity or alkalinity Aldehydes Arsenic Lead Mercury Not more than 1,0 % (105 °C, 3h) Not more than about 1,0 % (as sorbic acid or K2CO3) Not more than 0,1 %, calculated as formaldehyde Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 203 CALCIUM SORBATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Calcium sorbate Calcium salts of trans, trans‐2,4‐hexadienoic acid 231‐321‐6 C12H14O4Ca 262,32 Content not less than 98 % on the dried basis Fine white crystalline powder not showing any change in colour after heating at 105 °C for 90 minutes A. Melting range of sorbic acid isolated by acidification recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator and not B. Positive tests for calcium and for double bonds Purity Loss on drying Aldehydes Fluoride Arsenic Lead Mercury Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator Not more than 0,1 % (as formaldehyde) Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 54 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 E 210 BENZOIC ACID Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Benzoic acid Benzenecarboxylic acid Phenylcarboxylic acid 200‐618‐2 C7H6O2 122,12 Content not less than 99,5 % on the anhydrous basis White crystalline powder A. Melting range 121,5 °C to 123,5 °C B. Positive sublimation test and test for benzoate Purity Loss on drying Not more than 0,5 % after drying for three hours over sulphuric acid pH About 4 (solution in water) Sulphated ash Not more than 0,05 % Chlorinated organic compounds Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlo- robenzoic acid Readily oxidizable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required Readily carbonizable substances A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC (1), 0,3 ml of ferric chloride TSC (2), 0,1 ml of copper sulphate TSC (3)and 4,4 ml of water Polycyclic acids On fractional acidification of a neutralized solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 55 E 211 SODIUM BENZOATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Solubility Sodium benzoate Sodium salt of benzenecarboxylic acid Sodium salt of phenylcarboxylic acid 208‐534‐8 C7H5O2Na 144,11 Not less than 99 % of C7H5O2Na, after drying at 105 °C for four hours A white, almost odourless, crystalline powder or granules 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 so- dium Purity Loss on drying Not more than 1,5 % after drying at 105 °C for four hours Readily oxidizable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required Polycyclic acids On fractional acidification of a (neutralized) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monoch- lorobenzoic 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 Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 212 POTASSIUM BENZOATE Definition Chemical name Einecs Chemical formula Potassium benzoate Potassium salt of benzenecarboxylic acid Potassium salt of phenylcarboxylic acid 209‐481‐3 C7H5KO2·3H2O 56 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Molecular weight 214,27 Content not less than 99 % C7H5O2K after drying at 105 °C to constant weight White crystalline powder Assay Description Identification A. Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator B. Positive tests for benzoate and for po- tassium Purity Loss on drying Not more than 26,5 %, determined by drying at 105 °C Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monoch- lorobenzoic 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, require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl in the presence of phenolphthalein, must not Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 213 CALCIUM BENZOATE Synonyms Definition Chemical name Monocalcium benzoate Calcium benzoate Calcium dibenzoate 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 57 218‐235‐4 Anhydrous: Monohydrate: Trihydrate: Anhydrous: Monohydrate: Trihydrate: C14H10O4Ca C14H10O4Ca·H2O C14H10O4CA·3H2O 282,31 300,32 336,36 Content not less than 99 % after drying at 105 °C White or colourless crystals, or white powder Einecs Chemical formula Molecular weight Assay Description Identification A. Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator B. Positive tests for benzoate and for cal- cium Purity Loss on drying Not more than 17,5 % determined by drying at 105 °C to constant weight Water insoluble matter Not more than 0,3 % Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monoch- lorobenzoic 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 Arsenic Lead Mercury Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 214 ETHYL p‐HYDROXYBENZOATE Synonyms Ethylparaben Ethyl p‐oxybenzoate 58 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Ethyl‐p‐hydroxybenzoate Ethyl ester of p‐hydroxybenzoic acid 204‐399‐4 C9H10O3 166,8 Content not less than 99,5 % after drying for two hours at 80 °C Almost odourless, small, colourless crystals or a white, crystalline powder A. Melting range 115 °C to 118 °C B. Positive test for p‐hydroxybenzoate Melting range of p‐hydroxybenzoic acid isolated by acidification and not recrystallized: 213 °C to 217 °C, after vacuum drying in a sulphuric acid desiccator C. Positive test for alcohol Purity Loss on drying Sulphated ash Not more than 0,5 % after drying for two hours at 80 °C Not more than 0,05 % p‐Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p‐hydroxybenzoic acid Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 215 SODIUM ETHYL p‐HYDROXYBENZOATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Sodium ethyl p‐hydroxybenzoate Sodium compound of the ethyl ester of p‐hydroxybenzoic acid 252‐487‐6 C9H9O3Na 188,8 Content of ethylester of p‐hydroxybenzoic acid not less than 83 % on the anhydrous basis White, crystalline hygroscopic powder A. Melting range 115 °C to 118 °C, after vacuum drying in a sulphuric acid desiccator 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 59 B. Positive test for p‐hydroxybenzoate Melting range of p‐hydroxybenzoic acid derived from the sample is 213 °C to 217 °C C. Positive test for sodium D. pH of a 0,1 % aqueous solution must be between 9,9 and 10,3 Purity Loss on drying Sulphated ash Not more than 5 %, determined by vacuum drying in a sulphuric acid desiccator 37 to 39 % p‐Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p‐hydroxybenzoic acid Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 216 PROPYL p‐HYDROXYBENZOATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Propylparaben Propyl p‐oxybenzoate Propyl p‐hydroxybenzoate n‐Propyl p‐hydroxybenzoic acid 202‐307‐7 C10H12O3 180,21 Content not less than 99,5 % after drying for two hours at 80 °C Almost odourless, small, colourless crystals or a white, crystalline powder A. 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 Purity Loss on drying Sulphated ash Not more than 0,5 % after drying for two hours at 80 °C Not more than 0,05 % p‐Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p‐hydroxybenzoic acid Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 60 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 E 217 SODIUM PROPYL p‐HYDROXYBENZOATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Melting range of ester isolated by acidi- fication and not recrystallized: 94 °C to 97 °C, after vacuum drying in a sulp- huric acid desiccator B. Positive test for sodium C. pH of a 0,1 % aqueous solution must be between 9,8 and 10,2 Purity Loss on drying Sulphated ash Sodium n‐propyl p‐hydroxybenzoate Sodium compound of the n‐propylester of p‐hydroxybenzoic acid 252‐488‐1 C10H11O3Na 202,21 Content of the propyl ester of p‐hydroxybenzoic acid not less than 85 % on the anhydrous basis White, or almost white, crystalline hygroscopic powder Not more than 5 %, determined by vacuum drying in a sulphuric acid desiccator 34 to 36 % p‐Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p‐hydroxybenzoic acid Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 218 METHYL p‐HYDROXYBENZOATE Synonyms Definition Chemical name Einecs Chemical formula Methylparaben Methyl‐p‐oxybenzoate Methyl p‐hydroxybenzoate Methyl ester of p‐hydroxybenzoic acid 243‐171‐5 C8H8O3 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 61 Molecular weight 152,15 Assay Description Identification Content not less than 99 % after drying for two hours at 80 °C Almost odourless, small colourless crystals or white crystalline powder A. Melting range 125 °C to 128 °C B. Positive test for p‐hydroxybenzoate Melting range of p‐hydroxybenzoic acid derived from the sample is 213 °C to 217 °C after drying for two hours at 80 °C Purity Loss on drying Sulphated ash Not more than 0,5 %, after drying for two hours at 80 °C Not more than 0,05 % p‐Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p‐hydroxybenzoic acid Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 219 SODIUM METHYL p‐HYDROXYBENZOATE Sodium methyl p‐hydroxybenzoate Sodium compound of the methylester of p‐hydroxybenzoic acid C8H7O3Na 174,15 Content not less than 99,5 % on the anhydrous basis White, hygroscopic powder Definition Chemical name Chemical formula Molecular weight Assay Description Identification A. The white precipitate formed by acidi- fying 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 dio- xide free water, not less than 9,7 and not more than 10,3 62 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Purity Water content Sulphated ash Not more than 5 % (Karl Fischer method) 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 Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 220 SULPHUR DIOXIDE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Sulphur dioxide Sulphurous acid anhydride 231‐195‐2 SO2 64,07 Content not less than 99 % Colourless, non‐flammable gas with strong pungent suffocating odour A. Positive test for sulphurous substances Purity Water content Not more than 0,05 % Non‐volatile residue Not more than 0,01 % Sulphur trioxide Not more than 0,1 % Selenium Not more than 10 mg/kg Other gases not normally present in the air No trace Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 63 E 221 SODIUM SULPHITE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Positive tests for sulphite and for so- dium B. pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5 Purity Thiosulphate Iron Selenium Arsenic Lead Mercury Sodium sulphite (anhydrous or heptahydrate) 231‐821‐4 Anhydrous: Heptahydrate: Anhydrous: Heptahydrate: Anhydrous: Heptahydrate: White crystalline powder or colourless crystals Na2SO3 Na2SO37H2O 126,04 252,16 Not less than 95 % of Na2SO3 and not less than 48 % of SO2 Not less than 48 % of Na2SO3 and not less than 24 % of SO2 Not more than 0,1 % based on the SO2 content Not more than 50 mg/kg based on the SO2 content Not more than 10 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 222 SODIUM BISULPHITE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Sodium bisulphite Sodium hydrogen sulphite 231‐921‐4 NaHSO3 in aqueous solution 104,06 Content not less than 32 % w/w NaHSO3 A clear, colourless to yellow solution 64 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Identification A. Positive tests for sulphite and for so- dium B. pH of a 10 % aqueous solution bet- ween 2,5 and 5,5 Purity Iron Selenium Arsenic Lead Mercury Not more than 50 mg/kg of Na2SO3 based on the SO2 content Not more than 10 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 223 SODIUM METABISULPHITE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Pyrosulphite Sodium pyrosulphite Sodium disulphite Disodium pentaoxodisulphate 231‐673‐0 Na2S2O5 190,11 Content not less than 95 % Na2S2O5 and not less than 64 % of SO2 White crystals or crystalline powder A. Positive tests for sulphite and for so- dium B. pH of a 10 % aqueous solution bet- ween 4,0 and 5,5 Purity Thiosulphate Iron Selenium Arsenic Lead Not more than 0,1 % based on the SO2 content Not more than 50 mg/kg based on the SO2 content Not more than 10 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 5 mg/kg 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 65 Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 224 POTASSIUM METABISULPHITE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Potassium pyrosulphite Potassium disulphite Potassium pentaoxo disulphate 240‐795‐3 K2S2O5 222,33 Content not less than 90 % of K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate Colourless crystals or white crystalline powder Identification A. Positive tests for sulphite and for potas- sium Purity Thiosulphate Iron Selenium Arsenic Lead Mercury Not more than 0,1 % based on the SO2 content Not more than 50 mg/kg based on the SO2 content Not more than 10 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 226 CALCIUM SULPHITE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Calcium sulphite 218‐235‐4 CaSO3·2H2O 156,17 Content not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2 White crystals or white crystalline powder 66 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Identification A. Positive tests for sulphite and for cal- cium Purity Iron Selenium Arsenic Lead Mercury Not more than 50 mg/kg based on the SO2 content Not more than 10 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 227 CALCIUM BISULPHITE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Calcium bisulphite Calcium hydrogen sulphite 237‐423‐7 Ca(HSO3)2 202,22 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] Clear greenish‐yellow aqueous solution having a distinct odour of sulphur dioxide A. Positive tests for sulphite and for cal- cium Purity Iron Selenium Arsenic Lead Mercury Not more than 50 mg/kg based on the SO2 content Not more than 10 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 228 POTASSIUM BISULPHITE Definition Chemical name Potassium bisulphite Potassium hydrogen sulphite 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 67 Einecs Chemical formula Molecular weight Assay Description Identification A. Positive tests for sulphite and for potas- 231‐870‐1 KHSO3 in aqueous solution 120,17 Content not less than 280 g KHSO3 per litre (or 150 g SO2 per litre) Clear colourless aqueous solution sium Purity Iron Selenium Arsenic Lead Mercury Not more than 50 mg/kg based on the SO2 content Not more than 10 mg/kg based on the SO2 content Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 230 BIPHENYL Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Diphenyl 1,1′‐biphenyl Phenylbenzene 202‐163‐5 C12H10 154,20 Content not less than 99,8 % White or pale yellow to amber crystalline solid having a characteristic odour A. Melting range 68,5 °C to 70,5 °C B. Distillation range It distils completely within a 2,5 °C range between 252,5 °C and 257,5 °C Purity Benzene Aromatic amines Phenol derivatives Not more than 10 mg/kg Not more than 2 mg/kg (as aniline) Not more than 5 mg/kg (as phenol) 68 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 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 derivati- ves Not more than 0,2 % Polycyclic aromatic hydrocarbons Absent Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 231 ORTHOPHENYLPHENOL Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Orthoxenol (1,1'‐Biphenyl)‐2‐ol 2‐Hydroxydiphenyl o‐Hydroxydiphenyl 201‐993‐5 C12H10O 170,20 Content not less than 99 % White or slightly yellowish crystalline powder A. Melting range 56 °C to 58 °C B. Positive test for phenolate An ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solution Purity Sulphated ash Diphenyl ether p‐Phenylphenol 1‐Naphthol Arsenic Lead Mercury Not more than 0,05 % Not more than 0,3 % Not more than 0,1 % Not more than 0,01 % Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 69 E 232 SODIUM ORTHOPHENYLPHENOL Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Sodium orthophenylphenate Sodium salt of o‐phenylphenol Sodium orthophenylphenol 205‐055‐6 C12H9ONa·4H2O 264,26 Content not less than 97 % of C12H9ONa·4H2O White or slightly yellowish crystalline powder A. Positive tests for phenolate and for so- dium B. Melting range of orthophenylphenol iso- lated by acidification and not recrystalli- zed derived from the sample 56 °C to 58 °C after drying in a sulphuric acid desiccator C. pH of a 2 % aqueous solution must be between 11,1 and 11,8 Purity Diphenylether p‐phenylphenol 1‐naphthol Arsenic Lead Mercury Not more than 0,3 % Not more than 0,1 % Not more than 0,01 % Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 233 THIABENDAZOLE Definition Chemical name Einecs Chemical formula 4‐(2‐benzimidazolyl)thiazole 2‐(4‐thiazolyl)‐1H‐benzimidazole 1205‐725‐8 C10H7N3S 70 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Molecular weight 201,26 Assay Description Identification A. Melting range B. Spectrometry Purity Water content Sulphated ash Selenium Arsenic Lead Mercury Content not less than 98 % on the anhydrous basis White, or almost white, odourless powder 296 °C to 303 °C Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nm 1 % at 302 nm ± 2 nm: approximately 1 230 E 1 cm 1 % at 258 nm ± 2 nm: approximately 200 E 1 cm 1 % at 243 nm ± 2 nm: approximately 620 E 1 cm Ratio of absorption 243 nm/302 nm = 0,47 to 0,53 Ratio of absorption 258 nm/302 nm = 0,14 to 0,18 Not more than 0,5 % (Karl Fischer method) Not more than 0,2 % Not more than 3 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 234 NISIN Definition Einecs Chemical formula Molecular weight Assay Description Purity Nisin consists of several closely related polypeptides produced by natural strains of Streptococcus lactis, Lancefield group N 215‐807‐5 C143H230N42O37S7 3 354,12 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 % White powder Loss on drying Not more than 3 % when dried to constant weight at 102 °C to 103 °C Arsenic Lead Mercury Not more than 1 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 71 E 235 NATAMYCIN Synonyms Definition Einecs Chemical formula Molecular weight Assay Description Identification A. Colour reactions B. Spectrometry C. pH D. Specific rotation Purity Loss on drying Sulphated ash Arsenic Lead Mercury Pimaricin Natamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis 231‐683‐5 C33H47O13N 665,74 Content not less than 95 % on the anhydrous basis White to creamy‐white crystalline powder 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 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 5,5 to 7,5 (1 % w/v solution in previously neutralized mixture of 20 parts dimethylformamide and 80 parts of water) [α] D 20 = + 250 ° to + 295 ° (a 1 % w/v solution in glacial acetic acid, at 20 °C and calculated with reference to the dried material) Not more than 8 % (over P2O5, in vacuum at 60 °C to constant weight) Not more than 0,5 % Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Microbiological criteria: total viable count Not more than 100/g E 239 HEXAMETHYLENE TETRAMINE Synonyms Definition Chemical name Einecs Hexamine Methenamine 1,3,5,7‐Tetraazatricyclo [3. 3. 1. 13,7]‐decane, hexamethylenetetramine 202‐905‐8 72 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Chemical formula Molecular weight Assay Description Identification A. Positive tests for formaldehyde and for ammonia B. Sublimation point approximately 260 °C Purity Loss on drying Sulphated ash Sulphates Chlorides C6H12N4 140,19 Content not less than 99 % on the anhydrous basis Colourless or white crystalline powder Not more than 0,5 % after drying at 105 °C in vacuum over P2O5 for two hours Not more than 0,05 % Not more than 0,005 % expressed as SO4 Not more than 0,005 % expressed as Cl Ammonium salts Not detectable Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 242 DIMETHYL DICARBONATE Synonyms Definition Einecs Chemical name Chemical formula Molecular weight Assay Description DMDC Dimethyl pyrocarbonate 224‐859‐8 Dimethyl dicarbonate Pyrocarbonic acid dimethyl ester C4H6O5 134,09 Content not less than 99,8 % Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 73 Identification A. Decomposition B. Melting point Boiling point C. Density 20 °C After dilution positive tests for CO2 and methanol 17 °C 172 °C with decomposition Approximately 1,25 g/cm3 D. Infrared spectrum Maxima at 1 156 and 1 832 cm− 1 Purity Dimethyl carbonate Not more than 0,2 % Chlorine, total Not more than 3 mg/kg Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 249 POTASSIUM NITRITE Potassium nitrite 231‐832‐4 KNO2 85,11 Content not less than 95 % on the anhydrous basis (4) White or slightly yellow, deliquescent granules Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Positive tests for nitrite and for potas- sium B. pH of a 5 % solution: not less than 6,0 and not more than 9,0 Purity Loss on drying Not more than 3 % after drying for four hours over silica gel Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 74 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 E 250 SODIUM NITRITE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Sodium nitrite 231‐555‐9 NaNO2 69,00 Content not less than 97 % on the anhydrous basis (4) White crystalline powder or yellowish lumps A. Positive tests for nitrite and for sodium Purity Loss on drying Not more than 0,25 % after drying over silica gel for four hours Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 251 SODIUM NITRATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Chile saltpetre Cubic or soda nitre Sodium nitrate 231‐554‐3 NaNO3 85,00 Content not less than 99 % after drying at 105 °C for four hours White crystalline, slightly hygroscopic powder Identification A. Positive tests for nitrate and for sodium B. pH of a 5 % solution Not less than 5,5 and more than 8,3 C. Melting point: ± 308 °C 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 75 Purity Loss on drying Not more than 2 % after drying at 105 °C for four hours Nitrites Arsenic Lead Mercury Not more than 30 mg/kg expressed as NaNO2 Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 252 POTASSIUM NITRATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Chile saltpetre Cubic or soda nitre Potassium nitrate 231‐818‐8 KNO3 101,11 Content not less than 99 % on the anhydrous basis White crystalline powder or transparent prisms having a cooling, saline, pungent taste A. Positive tests for nitrate and for potas- sium B. pH of a 5 % solution Not less than 4,5 and not more than 8,5 Purity Loss on drying Not more than 1 % after drying at 105 °C for four hours Nitrites Arsenic Lead Mercury Not more than 20 mg/kg expressed as KNO2 Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 260 ACETIC ACID Definition Chemical name Acetic acid Ethanoic acid 76 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Einecs Chemical formula Molecular weight Assay Description Identification A. Boiling point B. Specific gravity 200‐580‐7 C2H4O2 60,05 Content not less than 99,8 % Clear, colourless liquid having a pungent, characteristic odour 118 °C at 760 mm pressure (of mercury) About 1,049 C. A one in three solution gives positive tests for acetate D. Solidification point Not lower than 14,5 °C Purity Non‐volatile residue Not more than 100 mg/kg Formic acid, formates and other oxidizable substances Not more than 1 000 mg/kg expressed as formic acid Readily oxidizable substances Dilute 2 ml of the sample in a glass‐stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes Arsenic Lead Mercury Not more than 1 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 261 POTASSIUM ACETATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Potassium acetate 204‐822‐2 C2H3O2K 98,14 Content not less than 99 % on the anhydrous basis Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour A. pH of a 5 % aqueous solution Not less than 7,5 and not more than 9,0 B. Positive tests for acetate and for potas- sium 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 77 Purity Loss on drying Not more than 8 % after drying at 150 °C for two hours Formic acid, formates and other oxidizable substances Not more than 1 000 mg/kg expressed as formic acid Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 262 (i) SODIUM ACETATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Sodium acetate 204‐823‐8 C2H3NaO2·nH2O (n = 0 or 3) Anhydrous: Trihydrate: 82,03 136,08 Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis Anhydrous: Trihydrate: White, odourless, granular, hygroscopic pow- der Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air A. pH of a 1 % aqueous solution Not less than 8,0 and not more than 9,5 B. Positive tests for acetate and for sodium Purity Loss on drying Anhydrous: Trihydrate: Not more than 2 % (120 °C, 4 hours) Between 36 and 42 % (120 °C, 4 hours) Formic acid, formates and other oxidizable substances Not more than 1 000 mg/kg expressed as formic acid Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 78 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 E 262 (ii) SODIUM DIACETATE Definition Sodium diacetate is a molecular compound of sodium acetate and acetic acid Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Sodium hydrogen diacetate 204‐814‐9 C4H7NaO4·nH2O (n = 0 or 3) 142,09 (anhydrous) Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate White, hygroscopic crystalline solid with an acetic odour A. pH of a 10 % aqueous solution Not less than 4,5 and not more than 5,0 B. Positive tests for acetate and for sodium Purity Water content Not more than 2 % (Karl Fischer method) Formic acid, formates and other oxidizable substances Not more than 1 000 mg/kg expressed as formic acid Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 263 CALCIUM ACETATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Calcium acetate 200‐540‐9 Anhydrous: Monohydrate: Anhydrous: Monohydrate: C4H6O4Ca C4H6O4Ca·H2O 158,17 176,18 Content not less than 98 % on the anhydrous basis 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 A. pH of a 10 % aqueous solution Not less than 6,0 and not more than 9,0 B. Positive tests for acetate and for calcium 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 79 Purity Loss on drying Not more than 11 % after drying (155 °C to constant weight, for the monohydrate) Water insoluble matter Not more than 0,3 % Formic acid, formates and other oxidizable substances Not more than 1 000 mg/kg expressed as formic acid Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 270 LACTIC ACID Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Note: Lactic acid 2‐Hydroxypropionic acid 1‐Hydroxyethane‐1‐carboxylic acid 200‐018‐0 C3H6O3 90,08 Content not less than 76 % and not more than 84 % 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 Lactic acid is hygroscopic and when con- centrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid Identification A. Positive test for lactate Purity Sulphated ash Not more than 0,1 % Chloride Sulphate Iron Arsenic Lead Not more than 0,2 % Not more than 0,25 % Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg 80 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 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, cal- culate values corresponding to their lactic acid content E 280 PROPIONIC ACID Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Indentification A. Melting point Propionic acid Propanoic acid 201‐176‐3 C3H6O2 74,08 Content not less than 99,5 % Colourless or slightly yellowish, oily liquid with a slightly pungent odour − 22 °C B. Distillation range 138,5 °C to 142,5 °C Purity Non‐volatile residue Aldehydes Arsenic Lead Mercury Not more than 0,01 % when dried at 140 °C to constant weight Not more than 0,1 % expressed as formaldehyde Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 281 SODIUM PROPIONATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Sodium propionate Sodium propanoate 205‐290‐4 C3H5O2Na 96,06 Content not less than 99 % after drying for two hours at 105 °C White crystalline hygroscopic powder, or a fine white powder 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 81 Identification A. Positive tests for propionate and for sodium B. pH of a 10 % aqueous solution Not less than 7,5 and not more than 10,5 Purity Loss on drying Water insolubles Iron Arsenic Lead Mercury Not more than 4 % determined by drying for two hours at 105 °C Not more than 0,1 % Not more than 50 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 282 CALCIUM PROPIONATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Calcium propionate 223‐795‐8 C6H10O4Ca 186,22 Content not less than 99 %, after drying for two hours at 105 °C White crystalline powder A. Positive tests calcium for propionate and for B. pH of a 10 % aqueous solution Between 6,0 and 9,0 Purity Loss on drying Water insolubles Iron Fluoride Arsenic Lead Mercury Not more than 4 %, determined by drying for two hours at 105 °C Not more than 0,3 % Not more than 50 mg/kg Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 82 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 E 283 POTASSIUM PROPIONATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Positive tests potassium for propionate and for Purity Potassium propionate Potassium propanoate 206‐323‐5 C3H5KO2 112,17 Content not less than 99 % after drying for two hours at 105 °C White crystalline powder Loss on drying Not more than 4 %, determined by drying for two hours at 105 °C Water‐insoluble substances Not more than 0,3 % Iron Fluoride Arsenic Lead Mercury Not more than 30 mg/kg Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 284 BORIC ACID Synonyms Definition Einecs Chemical formula Molecular weight Assay Description Identification Boracic acid Orthoboric acid Borofax 233‐139‐2 H3BO3 61,84 Content not less than 99,5 % Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite A. Melting point At approximately 171 °C B. Burns with a nice green flame C. pH of a 3,3 % aqueous solution Between 3,8 and 4,8 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 83 Purity Peroxides Arsenic Lead Mercury No colour develops with added KI‐solution Not more than 1 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 285 SODIUM TETRABORATE (BORAX) Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Description Identification Sodium borate Sodium tetraborate Sodium biborate Sodium pyroborate Anhydrous tetraborate 215‐540‐4 Na2B4O7 Na2B4O7·10H2O 201,27 Powder or glass‐like plates becoming opaque on exposure to air; slowly soluble in water A. Melting range Between 171 °C and 175 °C with decomposition Purity Peroxides Arsenic Lead Mercury No colour develops with added KI‐solution Not more than 1 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 290 CARBON DIOXIDE Synonyms Definition Chemical name Einecs Carbonic acid gas Dry ice (solid form) Carbonic anhydride Carbon dioxide 204‐696‐9 84 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Chemical formula Molecular weight Assay Description Identification CO2 44,01 Content not less than 99 % v/v on the gaseous basis 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 A. Precipitation (Precipitate formation) When a stream of precipitate is produced which dissolves with effervescence in dilute acetic acid the sample is passed through a solution of barium hydroxide, a white Purity Acidity 915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N) Reducing substances, hydrogen phosphide and sulphide 915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to which has been added 3 ml of ammonia must not cause clouding or blackening of this solution Carbon monoxide Oil content E 300 ASCORBIC ACID Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Not more than 10 μl/l Not more than 0,1 mg/l L‐ascorbic acid Ascorbic acid 2,3‐Didehydro‐L‐threo‐hexono‐1,4‐lactone 3‐Keto‐L‐gulofuranolactone 200‐066‐2 C6H8O6 176,13 Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6 White to pale yellow, odourless crystalline solid A. Melting range Between 189 °C and 193 °C with decomposition B. Positive tests for ascorbic acid Purity Loss on drying Sulphated ash Not more than 0,4 % after drying in a vacuum desiccator over sulphuric acid for 24 hours Not more than 0,1 % 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 85 Specific rotation [α] D 20 between + 20,5° and + 21,5° (10 % w/v aqueous solution) pH of a 2 % aqueous solution Between 2,4 and 2,8 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 301 SODIUM ASCORBATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Sodium ascorbate Sodium L‐ascorbate 2,3‐Didehydro‐L‐threo‐hexono‐1,4‐lactone sodium enolate 3‐Keto‐L‐gulofurano‐lactone sodium enolate 205‐126‐1 C6H7O6Na 198,11 Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na White or almost white, odourless crystalline solid which darkens on exposure to light A. Positive tests for ascorbate and for so- dium Purity Loss on drying Specific rotation Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours [α] D 20 between + 103 ° and + 106 ° (10 % w/v aqueous solution) pH of 10 % aqueous solution Between 6,5 and 8,0 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 302 CALCIUM ASCORBATE Definition Chemical name Calcium ascorbate dihydrate Calcium salt of 2,3‐didehydro‐L‐threo‐hexono‐1,4‐lactone dihydrate 86 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Einecs Chemical formula Molecular weight Assay Description Identification 227‐261‐5 C12H14O12Ca·2H2O 426,35 Content not less than 98 % on a volatile matter‐free basis White to slightly pale greyish‐yellow odourless crystalline powder A. Positive tests for ascorbate and for cal- cium Purity Fluoride Not more than 10 mg/kg (expressed as fluorine) Specific rotation [α] D 20 between + 95 ° and + 97 ° (5 % w/v aqueous solution) pH of 10 % aqueous solution Between 6,0 and 7,5 Volatile matter Arsenic Lead Mercury Not more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 304 (i) ASCORBYL PALMITATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Ascorbyl palmitate L‐ascorbyl palmitate 2,3‐didehydro‐L‐threo‐hexono‐1,4‐lactone‐6‐palmitate 6‐palmitoyl‐3‐keto‐L‐gulofuranolactone 205‐305‐4 C22H38O7 414,55 Content not less than 98 % on the dried basis White or yellowish‐white solid with a citrus‐like odour A. Melting range Between 107 °C and 117 °C Purity Loss on drying Sulphated ash Not more than 2,0 % after drying in a vacuum oven at 56 °C and 60 °C for one hour Not more than 0,1 % 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 87 Specific rotation [α] D 20 between + 21 ° and + 24 ° (5 % w/v in methanol solution) Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 304 (ii) ASCORBYL STEARATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Ascorbyl stearate L‐ascorbyl stearate 2,3‐didehydro‐L‐threo‐hexono‐1,4‐lactone‐6‐stearate 6‐stearoyl‐3‐keto‐L‐gulofuranolactone 246‐944‐9 C24H42O7 442,6 Content not less than 98 % White or yellowish, white solid with a citrus‐like odour A. Melting point About 116 °C Purity Loss on drying Sulphated ash Arsenic Lead Mercury Not more than 2,0 % after drying in a vacuum oven at 56 °C to 60 °C for one hour Not more than 0,1 % Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 306 TOCOPHEROL‐RICH EXTRACT Definition Molecular weight Assay Description 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 430,71 (d‐α‐tocopherol) Content not less than 34 % of total tocopherols 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 88 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Identification A. By suitable gas liquid chromatographic method B. Solubility tests Insoluble in water. Soluble in ethanol. Miscible in ether Purity Sulphated ash Specific rotation Arsenic Lead Mercury Not more than 0,1 % [α] D 20 not less than + 20 ° Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 307 ALPHA‐TOCOPHEROL Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification dl‐α‐Tocopherol dl‐5,7,8‐Trimethyltocol dl‐2,5,7,8‐tetramethyl‐2‐(4′,8′,12′‐trimethyltridecyl)‐6‐chromanol 200‐412‐2 C29H50O2 430,71 Content not less than 96 % Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidizes and darkens on exposure to air or light A. Solubility tests Insoluble in water, freely soluble in ethanol, miscible in ether B. Spectrophotometry In absolute ethanol the maximum absorption is about 292 nm Purity Refractive index 20 1,503 — 1,507 n D Specific absorption E 1 cm 1 % in ethanol E 1 cm 1 % (292 nm) 72—76 (0,01 g in 200 ml of absolute ethanol) Sulphated ash Specific rotation Arsenic Lead Mercury Not more than 0,1 % [α] D 20 0° ± 0,05° (1 in 10 solution in chloroform) Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 89 E 308 GAMMA‐TOCOPHEROL Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification dl‐γ‐Tocopherol 2,7,8‐trimethyl‐2‐(4′,8′,12′‐trimethyltridecyl)‐6‐chromanol 231‐523‐4 C28H48O2 416,69 Content not less than 97 % Clear, viscous, pale yellow oil which oxidizes and darkens on exposure to air or light A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm Purity Specific absorption E 1 cm 1 % in ethanol E 1 cm E 1 cm 1 % (298 nm) between 91 and 97 1 % (257 nm) between 5,0 and 8,0 Refractive index Sulphated ash Arsenic Lead Mercury 20 1,503—1,507 n D Not more than 0,1 % Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 309 DELTA‐TOCOPHEROL Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification 2,8‐dimethyl‐2‐(4′,8′,12′‐trimethyltridecyl)‐6‐chromanol 204‐299‐0 C27H46O2 402,7 Content not less than 97 % Clear, viscous, pale yellowish or orange oil which oxidizes and darkens on exposure to air or light A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm 90 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Purity Specific absorption E 1 cm 1 % in ethanol E 1 cm E 1 cm 1 % (298 nm) between 89 and 95 1 % (257 nm) between 3,0 and 6,0 Refractive index Sulphated ash Arsenic Lead Mercury 20 1,500—1,504 n D Not more than 0,1 % Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 310 PROPYL GALLATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Solubility tests B. Melting range Purity Loss on drying Sulphated ash Free acid Propyl gallate Propyl ester of gallic acid n‐propyl ester of 3,4,5‐trihydroxybenzoic acid 204‐498‐2 C10H12O5 212,20 Content not less than 98 % on the anhydrous basis White to creamy‐white, crystalline, odourless solid Slightly soluble in water, freely soluble in ethanol, ether and propane‐1,2‐diol Between 146 °C and 150 °C after drying at 110 °C for four hours Not more than 1,0 % (110 °C, four hours) Not more than 0,1 % Not more than 0,5 % (as gallic acid) Chlorinated organic compound Not more than 100 mg/kg (as C1) Specific absorption E 1 cm 1 % in ethanol E 1 cm 1 % (275 nm) not less than 485 and not more than 520 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 91 E 311 OCTYL GALLATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Solubility tests B. Melting range Purity Loss on drying Sulphated ash Free acid Octyl gallate Octyl ester of gallic acid n‐octyl ester of 3,4,5‐trihydroxybenzoic acid 213‐853‐0 C15H22O5 282,34 Content not less than 98 % after drying at 90 °C for six hours White to creamy‐white odourless solid Insoluble in water, freely soluble in ethanol, ether and propane‐1,2‐diol Between 99 °C and 102 °C after drying at 90 °C for six hours Not more than 0,5 % (90 °C, six hours) Not more than 0,05 % Not more than 0,5 % (as gallic acid) Chlorinated organic compound Not more than 100 mg/kg (as C1) Specific absorption E 1 cm 1 % in ethanol E 1 cm 1 % (275 nm) not less than 375 and not more than 390 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 312 DODECYL GALLATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Lauryl gallate Dodecyl gallate n‐dodecyl (or lauryl) ester of 3,4,5‐trihydroxybenzoic acid Dodecyl ester of gallic acid 214‐620‐6 C19H30O5 338,45 Content not less than 98 % after drying at 90 °C for six hours White or creamy‐white odourless solid 92 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Identification A. Solubility tests B. Melting range Purity Loss on drying Sulphated ash Free acid Insoluble in water, freely soluble in ethanol and ether Between 95 °C and 98 °C after drying at 90 °C for six hours Not more than 0,5 % (90 °C, six hours) Not more than 0,05 % Not more than 0,5 % (as gallic acid) Chlorinated organic compound Not more than 100 mg/kg (as Cl) Specific absorption E 1 cm 1 % in ethanol E 1 cm 1 % (275 nm) not less than 300 and not more than 325 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 10 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 30 mg/kg E 315 ERYTHORBIC ACID Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Isoascorbic acid D‐araboascorbic acid D‐Erythro‐hex‐2‐enoic acid γ‐lactone Isoascorbic acid D‐isoascorbic acid 201‐928‐0 C6H8O6 176,13 Content not less than 98 % on the anhydrous basis White to slightly yellow crystalline solid which darkens gradually on exposure to light A. Melting range About 164 °C to 172 °C with decomposition B. Positive reaction test for ascorbic acid/colour Purity Loss on drying Sulphated ash Not more than 0,4 % after drying under reduced pressure on silica gel for 3 hours Not more than 0,3 % 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 93 Specific rotation [α] D 25 10 % (w/v) aqueous solution between − 16,5° to − 18,0 ° Oxalate Arsenic Lead Mercury 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 Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 316 SODIUM ERYTHORBATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Sodium isoascorbate 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 228‐973‐9 C6H7O6Na·H2O 216,13 Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis White crystalline solid A. Solubility tests Freely soluble in water, very slightly soluble in ethanol B. Positive reaction test for ascorbic acid/colour C. Positive test for sodium Purity Loss on drying Specific rotation Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours [α] D 25 10 % (w/v) aqueous solution between + 95 ° and + 98 ° pH of a 10 % aqueous solution 5,5 to 8,0 Oxalate Arsenic Lead Mercury 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 Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 94 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 E 320 BUTYLATED HYDROXYANISOLE (BHA) Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Solubility tests B. Melting range Purity BHA 3‐Tertiary‐butyl‐4‐hydroxyanisole A mixture of 2‐tertiarybutyl‐4‐hydroxyanisole and 3‐tertiarybutyl‐4‐hydroxyanisole 246‐563‐8 C11H16O2 180,25 Content not less than 98,5 % of C11H16O2 and not less than 85 % of 3‐tertiary‐butyl‐4‐hydro- xyanisole isomer White or slightly yellow crystals or waxy solid with a slight aromatic smell Insoluble in water Between 48 °C and 55 °C Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 °C Phenolic impurities Not more than 0,5 % Specific absorption E 1 cm 1 % in ethanol E 1 cm E 1 cm 1 % (290 nm) not less than 190 and not more than 210 1 % (228 nm) not less than 326 and not more than 345 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 321 BUTYLATED HYDROXYTOLUENE (BHT) Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description BHT 2,6‐Ditertiary‐butyl‐p‐cresol 4‐Methyl‐2,6‐ditertiarybutylphenol 204‐881‐4 C15H24O 220,36 Content not less than 99 % White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 95 Identification A. Solubility tests Insoluble in water and propane‐ 1,2‐diol Freely soluble in ethanol B. Melting point At 70 °C C. Absorbance maximum The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm Purity Sulphated ash Not more than 0,005 % Phenolic impurities Not more than 0,5 % Specific absorption E 1 cm 1 % in ethanol E 1 cm 1 % (278 nm) not less than 81 and not more than 88 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 322 LECITHINS Synonyms Definition Einecs Assay Description Identification Phosphatides Phospholipids 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 232‐307‐2 — Lecithins: not less than 60,0 % of substances insoluble in acetone — Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone — Lecithins: brown liquid or viscous semi‐liquid or powder — Hydrolysed lecithins: light brown to brown viscous liquid or paste A. Positive tests for choline, for phospho- rus and fatty acids B. Test for hydrolysed lecithin Purity 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‐hy- drolysed lecithin will form a distinct mass of about 50 g Loss on drying Not more than 2,0 % determined by drying at 105 °C for one hour Toluene‐insoluble matter Not more than 0,3 % Acid value — Lecithins: not more than 35 mg of potassium hydroxide per gram — Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram 96 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Peroxide value Equal to or less than 10 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 325 SODIUM LACTATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Positive test for lactate B. Positive test for potassium Purity Acidity Sodium lactate Sodium 2‐hydroxypropanoate 200‐772‐0 C3H5NaO3 112,06 (anhydrous) Content not less than 57 % and not more than 66 % Colourless, transparent, liquid Odourless, or with a slight, characteristic odour Not more than 0,5 % after drying expressed as lactic acid pH of a 20 % aqueous solution 6,5 to 7,5 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Reducing substances No reduction of Fehling's solution Note: This specification refers to a 60 % aqueous solution E 326 POTASSIUM LACTATE Definition Cheminal name Potassium lactate Potassium 2‐hydroxypropanoate Einecs 213‐631‐3 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 97 Chemical formula Molecular weight Assay Description Identification A. Ignition C3H5O3K 128,17 (anhydrous) Content not less than 57 % and not more than 66 % Slightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour 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 sulphuric acid. A deep red colour is produced at the zone of contact in C. Positive tests for potassium and for lactate Purity Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Acidity Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required Reducing substances Potassium lactate solution shall not cause any reduction of Fehling's solution Note: This specification refers to a 60 % aqueous solution E 327 CALCIUM LACTATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Calcium dilactate Calcium dilactate hydrate 2‐Hydroxypropanoic acid calcium salt 212‐406‐7 (C3H5O2)2 Ca·nH2O (n = 0—5) 218,22 (anhydrous) Content not less than 98 % on the anhydrous basis Almost odourless, white crystalline powder or granules A. Positive tests for lactate and for calcium B. Solubility tests Soluble in water and practically insoluble in ethanol 98 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Purity Loss on drying Determined by drying at 120 °C for four hours: — anhydrous: not more than 3,0 % — with 1 molecule of water: not more than 8,0 % — with 3 molecules of water: not more than 20,0 % — with 4,5 molecules of water: not more than 27,0 % Acidity Fluoride Not more than 0,5 % of the dry matter expressed as lactic acid Not more than 30 mg/kg (expressed as fluorine) pH of a 5 % solution Between 6,0 and 8,0 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Reducing substances No reduction of Fehling's solution E 330 CITRIC ACID Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Citric acid 2‐Hydroxy‐1,2,3‐propanetricarboxylic acid β‐Hydroxytricarballytic acid 201‐069‐1 (a) C6H8O7 (anhydrous) (b) C6H8O7·H2O (monohydrate) (a) 192,13 (anhydrous) (b) 210,15 (monohydrate) 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 Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air A. Solubility tests Very soluble in water; freely soluble in ethanol; soluble in ether Purity Water content Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method) Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 °C Arsenic Lead Mercury Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 99 Heavy metals (as Pb) Not more than 5 mg/kg Oxalates Not more than 100 mg/kg, expressed as oxalic acid, after drying Readily carbonizable substances Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 °C in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K) E 331 (i) MONOSODIUM CITRATE Synonyms Definition Chemical name Chemical formula Molecular weight Assay Description Identification Monosodium citrate Monobasic sodium citrate Monosodium citrate Monosodium salt of 2‐hydroxy‐1,2,3‐propanetricarboxylic acid (a) C6H7O7Na (anhydrous) (b) C6H7O7Na·H2O (monohydrate) (a) 214,11 (anhydrous) (b) 232,23 (monohydrate) Content not less than 99 % on the anhydrous basis Crystalline white powder or colourless crystals A. Positive tests for citrate and for sodium Purity Loss on drying Determined by drying at 180 °C for four hours: — anhydrous: not more than 1,0 % — monohydrate: not more than 8,8 % Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying pH of a 1 % aqueous solution Between 3,5 and 3,8 Arsenic Lead Mercury Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg E 331 (ii) DISODIUM CITRATE Synonyms Definition Chemical name Disodium citrate Dibasic sodium citrate Disodium citrate Disodium salt of 2‐hydroxy‐1,2,3‐propanetricarboxylic acid Disodium salt of citric acid with 1,5 molecules of water 100 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 205‐623‐3 C6H6O7Na2·1,5H2O 263,11 Content not less than 99 % on the anhydrous basis Crystalline white powder or colourless crystals Einecs Chemical formula Molecular weight Assay Description Identification A. Positive tests for citrate and for sodium Purity Loss on drying Not more than 13,0 % by drying at 180 °C for four hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying pH of a 1 % aqueous solution Between 4,9 and 5,2 Arsenic Lead Mercury Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg E 331 (iii) TRISODIUM CITRATE Synonyms Definition Chemical name Einecs Chemical formula Trisodium citrate Tribasic sodium citrate Trisodium citrate Trisodium salt of 2‐hydroxy‐1,2,3‐propanetricarboxylic acid Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form 200‐675‐3 Anhydrous: Hydrated: C6H5O7Na3 C6H5O7Na3·nH2O (n = 2 or 5) Molecular weight 258,07 (anhydrous) Assay Description Identification A. Positive tests for citrate and for sodium Not less than 99 % on the anhydrous basis Crystalline white powder or colourless crystals 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 101 Purity Loss on drying Determined by drying at 180 °C for four hours: — anhydrous: — dihydrate: — pentahydrate: not more than 1,0 % not more than 13,5 % 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 Lead Mercury Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg E 332 (i) MONOPOTASSIUM CITRATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Monopotassium citrate Monobasic potassium citrate Monopotassium citrate Monopotassium salt of 2‐hydroxy‐1,2,3‐propanetricarboxylic acid Anhydrous monopotassium salt of citric acid 212‐753‐4 C6H7O7K 230,21 Content not less than 99 % on the anhydrous basis White, hygroscopic, granular powder or transparent crystals Identification A. Positive tests for citrate and for potas- sium Purity Loss on drying Oxalates Not more than 1,0 % determined by drying at 180 °C for four hours 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 Lead Mercury Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg 102 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 E 332 (ii) TRIPOTASSIUM CITRATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Tripotassium citrate Tribasic potassium citrate Tripotassium citrate Tripotassium salt of 2‐hydroxy‐1,2,3‐propanetricarboxylic acid Monohydrated tripotassium salt of citric acid 212‐755‐5 C6H5O7K3·H2O 324,42 Content not less than 99 % on the anhydrous basis White, hygroscopic, granular powder or transparent crystals A. Positive tests for citrate and for potas- sium Purity Loss on drying Oxalates Not more than 6,0 % determined by drying at 180 °C for four hours 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 Lead Mercury Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg E 333 (i) MONOCALCIUM CITRATE Synonyms Definition Chemical name Chemical formula Molecular weight Assay Description Identification A. Positive tests for citrate and for calcium Monocalcium citrate Monobasic calcium citrate Monocalcium citrate Monocalcium salt of 2‐hydroxy‐1,2,3‐propanetricarboxylic acid Monohydrate monocalcium salt of citric acid (C6H7O7)2Ca·H2O 440,32 Content not less than 97,5 % on the anhydrous basis Fine white powder 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 103 Purity Loss on drying Oxalates Not more than 7,0 % determined by drying at 180 °C for four hours 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 Arsenic Lead Mercury Not more than 30 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles E 333 (ii) DICALCIUM CITRATE Synonyms Definition Chemical name Chemical formula Molecular weight Assay Description Identification A. Positive tests for citrate and for calcium Purity Dicalcium citrate Dibasic calcium citrate Dicalcium citrate Dicalcium salt of 2‐hydroxy‐1,2,3‐propanetricarboxylic acid Trihydrated dicalcium salt of citric acid (C6H7O7)2Ca2·3H2O 530,42 Not less than 97,5 % on the anhydrous basis Fine white powder Loss on drying Not more than 20,0 % determined by drying at 180 °C for four hours Oxalates Fluoride Arsenic Lead Mercury Not more than 100 mg/kg expressed as oxalic acid, after drying Not more than 30 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg 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 104 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 E 333 (iii) TRICALCIUM CITRATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Positive tests for citrate and for calcium Purity Tricalcium citrate Tribasic calcium citrate Tricalcium citrate Tricalcium salt of 2‐hydroxy‐1,2,3‐propanetricarboxylic acid Tetrahydrated tricalcium salt of citric acid 212‐391‐7 (C6H6O7)2Ca3·4H2O 570,51 Not less than 97,5 % on the anhydrous basis Fine white powder Loss on drying Not more than 14,0 % determined by drying at 180 °C for four hours Oxalates Fluoride Arsenic Lead Mercury Not more than 100 mg/kg expressed as oxalic acid, after drying Not more than 30 mg/kg (expressed as fluorine) Not more than 1 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles E 334 L(+)‐TARTARIC ACID Definition Chemical name Einecs Chemical formula Molecular weight Assay Description L‐tartaric acid L‐2,3‐dihydroxybutanedioic acid d‐α,β‐dihydroxysuccinic acid 201‐766‐0 C4H6O6 150,09 Content not less than 99,5 % on the anhydrous basis Colourless or translucent crystalline solid or white crystalline powder 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 105 Identification A. Melting range Between 168 °C and 170 °C B. Positive test for tartrate Purity Loss on drying Sulphated ash Not more than 0,5 % (over P2O5, three hours) Not more than 1 000 mg/kg after calcination at 800 ± 25 °C Specific optical rotation of a 20 % w/v aqueous solution [α] D 20 between + 11,5° and + 13,5 ° Lead Mercury Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying E 335 (i) MONOSODIUM TARTRATE Synonyms Definition Chemical name Chemical formula Molecular weight Assay Description Identification Monosodium salt of L‐(+)‐tartaric acid Monosodium salt of L‐2,3‐dihydroxybutanedioic acid Monohydrated monosodium salt of L‐(+)‐tartaric acid C4H5O6Na·H2O 194,05 Content not less than 99 % on the anhydrous basis Transparent colourless crystals A. Positive tests for tartrate and for so- dium Purity Loss on drying Not more than 10,0 % determined by drying at 105 °C for four hours Oxalates Arsenic Lead Mercury Not more than 100 mg/kg expressed as oxalic acid, after drying Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 106 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 E 335 (ii) DISODIUM TARTRATE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Disodium L‐tartrate Disodium (+)‐tartrate Disodium (+)‐2,3‐dihydroxybutanedioic acid Dihydrated disodium salt of L‐(+)‐tartaric acid 212‐773‐3 C4H4O6Na2·2H2O 230,8 Content not less than 99 % on the anhydrous basis Transparent, colourless crystals A. Positive tests for tartrate and for so- dium B. Solubility tests 1 gram is insoluble in 3 ml of water. Insoluble in ethanol Purity Loss on drying Oxalates Not more than 17,0 % determined by drying at 150 °C for four hours 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 Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 336 (i) MONOPOTASSIUM TARTRATE Synonyms Definition Chemical name Chemical formula Molecular weight Assay Description Monobasic potassium tartrate Anhydrous monopotassium salt of L‐(+)‐tartaric acid Monopotassium salt of L‐2,3‐dihydroxybutanedioic acid C4H5O6K 188,16 Content not less than 98 % on the anhydrous basis White crystalline or granulated powder 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 107 Identification A. Positive tests for tartrate and for potas- sium B. Melting point 230 °C Purity pH of a 1 % aqueous solution 3,4 Loss on drying Not more than 1,0 % determined by drying at 105 °C for four hours Oxalates Arsenic Lead Mercury Not more than 100 mg/kg expressed as oxalic acid, after drying Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 336 (ii) DIPOTASSIUM TARTRATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Dibasic potassium tartrate Dipotassium salt of L‐2,3‐dihydroxybutanedioic acid Dipotassium salt with half a molecule of water of L‐(+)‐tartaric acid 213‐067‐8 C4H4O6K2·½H2O 235,2 Content not less than 99 % on the anhydrous basis White crystalline or granulated powder Identification A. Positive tests for tartrate and for potas- sium Purity pH of a 1 % aqueous solution Between 7,0 and 9,0 Loss on drying Not more than 4,0 % determined by drying at 150 °C for four hours Oxalates Arsenic Lead Mercury Not more than 100 mg/kg expressed as oxalic acid, after drying Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 108 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 E 337 POTASSIUM SODIUM TARTRATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Positive tests for tartrate, for potassium and for sodium B. Solubility tests C. Melting range Purity Loss on drying Potassium sodium L‐(+)‐tartrate Rochelle salt Seignette salt Potassium sodium salt of L‐2,3‐dihydroxybutanedioic acid Potassium sodium L‐(+)‐tartrate 206‐156‐8 C4H4O6KNa·4H2O 282,23 Content not less than 99 % on the anhydrous basis Colourless crystals or white crystalline powder 1 gram is soluble in 1 ml of water, insoluble in ethanol Between 70 and 80 °C 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 Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 338 PHOSPHORIC ACID Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Orthophosphoric acid Monophosphoric acid Phosphoric acid 231‐633‐2 H3PO4 98,00 Content not less than 71 % and not more than 83 % Clear, colourless, viscous liquid 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 109 Identification A. Positive tests for acid and for phosphate Purity Volatile acids Not more than 10 mg/kg (as acetic acid) Chlorides Nitrates Sulphates Fluoride Arsenic Lead Mercury Not more than 200 mg/kg (expressed as chlorine) Not more than 5 mg/kg (as NaNO3) Not more than 1500 mg/kg (as CaSO4) Not more than 10 mg/kg (expressed as fluorine) Not more than 3 mg/kg Not more than 5 mg/kg 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 PHOSPHATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Monosodium monophosphate Acid monosodium monophosphate Monosodium orthophosphate Monobasic sodium phosphate Sodium dihydrogen monophosphate 231‐449‐2 Anhydrous: Monohydrate: Dihydrate: Anhydrous: Monohydrate: Dihydrate: NaH2PO4 NaH2PO4·H2O NaH2PO4·2H2O 119,98 138,00 156,01 After drying at 6,0 °C for one hour and then at 105 °C for four hours, contains not less than 97 % of NaH2PO4 A white odourless, slightly deliquescent powder, crystals or granules A. Positive tests for sodium and for phosp- hate B. Solubility tests C. P2O5 content Freely soluble in water. Insoluble in ethanol, ether or chloroform Between 58,0% and 60,0% 110 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Purity Loss 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 Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 339 (ii) DISODIUM PHOSPHATE Synonyms Definition Chemical name Einecs Chemical formula Disodium monophosphate Secondary sodium phosphate Disodium orthophosphate Acid disodium phosphate Disodium hydrogen monophosphate Disodium hydrogen orthophosphate 231‐448‐7 Anhydrous: Hydrated: Molecular weight 141,98 (anhydrous) Na2HPO4 Na2HPO4·nH2O (n = 2, 7 or 12) Assay Description Identification A. Positive tests for sodium and for phosp- hate B. Solubility tests C. P2O5 content Purity Loss on drying After drying at 40 °C for three hours and subsequently at 105 °C for five hours, contains not less than 98 % of Na2HPO4 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 Freely soluble in water. Insoluble in ethanol Between 49 % and 51 % (anhydrous) 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 % 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 111 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 Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 339 (iii) TRISODIUM PHOSPHATE Synonyms Definition Chemical name Einecs Chemical formula Sodium phosphate Tribasic sodium phosphate Trisodium orthophosphate Trisodium monophosphate Trisodium phosphate Trisodium orthophosphate 231‐509‐8 Anhydrous: Hydrated: Molecular weight 163,94 (anhydrous) Na3PO4 Na3PO4·nH2O (n = 0,5, 1 or 12) Assay Description Identification 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 White odourless crystals, granules or a crystalline powder. Hydrated forms available include hemi‐ and monohydrates, hexahydrate, octahydrate, decahydrate and dodecahydrate. The dode- cahydrate contains ¼ molecule of sodium hydroxide A. Positive tests for sodium and for phosp- hate B. Solubility tests Freely soluble in water. Insoluble in ethanol C. P2O5 content Between 40,5 % and 43,5 % (anhydrous) Purity Loss on ignition When dried at 120 °C for two hours and then ignited at about 800 °C for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate: not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 % Water‐insoluble substances Not more than 0,2 % on the anhydrous basis Fluoride Not more than 10 mg/kg (expressed as fluorine) 112 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 pH of a 1,0 % aqueous solution Between 11,5 and 12,5 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 340 (i) MONOPOTASSIUM PHOSPHATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Monobasic potassium phosphate Monopotassium monophosphate Potassium acid phosphate Potassium orthophosphate Potassium dihydrogen phosphate Monopotassium dihydrogen orthophosphate Monopotassium dihydrogen monophosphate 231‐913‐4 KH2PO4 136,09 Content not less than 98,0 % after drying at 105 °C for four hours Odourless, colourless crystals or white granular or crystalline powder, hygroscopic A. Positive tests phosphate for potassium and for B. Solubility tests Freely soluble in water. Insoluble in ethanol C. P2O5 content Between 51,0 % and 53,0 % Purity Loss on drying Not more than 2,0 % determined by drying at 105 °C for four hours Water‐insoluble substances Not more than 0,2 % on the anhydrous basis Fluoride Not more than 10 mg/kg (expressed as fluorine) pH of a 1 % aqueous solution Between 4,2 and 4,8 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 113 E 340 (ii) DIPOTASSIUM PHOSPHATE Dipotassium monophosphate Secondary potassium phosphate Dipotassium acid phosphate Dipotassium orthophosphate Dibasic potassium phosphate Dipotassium hydrogen monophosphate Dipotassium hydrogen phosphate Dipotassium hydrogen orthophosphate 231‐834‐5 K2HPO4 174,18 Content not less than 98 % after drying at 105 °C for four hours Colourless or white granular powder, crystals or masses; deliquescent substance for potassium and for Freely soluble in water. Insoluble in ethanol Between 40,3 % and 41,5 % Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Positive tests phosphate B. Solubility tests C. P2O5 content Purity Loss on drying Not more than 2,0 % determined by drying at 105 °C for four hours Water‐insoluble substances Not more than 0,2 % on the anhydrous basis Fluoride Not more than 10 mg/kg (expressed as fluorine) pH of a 1 % aqueous solution Between 8,7 and 9,4 Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 340 (iii) TRIPOTASSIUM PHOSPHATE Synonyms Definition Chemical name Potassium phosphate Tribasic potassium phosphate Tripotassium orthophosphate Tripotassium monophosphate Tripotassium phosphate Tripotassium orthophosphate 114 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Einecs Chemical formula 231‐907‐1 Anhydrous: Hydrated: Molecular weight 212,27 (anhydrous) K3PO4 K3PO4·nH2O (n = 1 or 3) Assay Description Identification A. Positive tests phosphate B. Solubility tests C. P2O5 content Purity Loss on ignition Content not less than 97 % calculated on the ignited basis Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate for potassium and for Freely soluble in water. Insoluble in ethanol Between 30,5 % and 33,0 % (anhydrous on ignited basis) 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 Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 341 (i) MONOCALCIUM PHOSPHATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Monobasic calcium phosphate Monocalcium orthophosphate Calcium dihydrogen phosphate 231‐837‐1 Anhydrous: Monohydrate: 234,05 (anhydrous) 252,08 (monohydrate) Ca(H2PO4)2 Ca(H2PO4)2·H2O Content not less than 95 % on the dried basis Granular powder or white, deliquescent crystals or granules 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 115 Identification A. Positive tests for calcium and for phosphate B. P2O5 content C. CaO content Purity Loss on drying Loss on ignition Fluoride Arsenic Lead Mercury Between 55,5 % and 61,1 % (anhydrous) Between 23,0 % and 27,5 % (anhydrous) Between 19,0 % and 24,8 % (monohydrate) 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) 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) Not more than 30 mg/kg (expressed as fluorine) Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 341 (ii) DICALCIUM PHOSPHATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Dibasic calcium phosphate Dicalcium orthophosphate Calcium monohydrogen phosphate Calcium hydrogen orthophosphate Secondary calcium phosphate 231‐826‐1 Anhydrous: Dihydrate: 136,06 (anhydrous) 172,09 (dihydrate) CaHPO4 CaHPO4·2H2O 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 White crystals or granules, granular powder or powder A. Positive tests for calcium and for phosphate B. Solubility tests C. P2O5 content Sparingly soluble in water. Insoluble in ethanol Between 50,0 % and 52,5 % (anhydrous) 116 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Purity Loss on ignition Fluoride Arsenic Lead Mercury Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 °C ± 25 °C for 30 minutes Not more than 50 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 341 (iii) TRICALCIUM PHOSPHATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Calcium phosphate, tribasic Calcium orthophosphate Tricalcium monophosphate 231‐840‐8 Ca3(PO4)2 310,17 Not less than 90 % calculated on the ignited basis A white, odourless and tasteless powder which is stable in air A. 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) Purity Loss on ignition Not more than 8 % after ignition at 800 °C ± 25 °C, to constant weight Fluoride Arsenic Lead Mercury Not more than 50 mg/kg (expressed as fluorine) Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 13/Vol. 18 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 117 E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Calcium disodium EDTA Calcium disodium edetate 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 200‐529‐9 C10H12O8CaN2Na2·2H2O 410,31 Content not less than 97 % on the anhydrous basis White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic A. Positive tests for sodium and for cal- cium B. Chelating activity to metal ions positive C. pH of a 1 % solution between 6,5 and 7,5 Purity Water content 5 to 13 % (Karl Fischer method) Arsenic Lead Mercury Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 1105 LYSOZYME Synonyms Definition Lysozyme hydrochloride Muramidase 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‐acetyl- muramic acid and N‐acetylglucosamine in the outer membranes of bacterial species, in particular gram‐positive organisms. Is usually obtained as the hydrochloride Chemical name Einecs Enzyme Commission (EC) No: 3. 2. 1. 17 232‐620‐4 118 MT Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea 13/Vol. 18 Molecular weight Assay Description Identification A. Isoelectric point 10,7 B. pH of a 2 % aqueous solution between 3,0 and 3,6 C. Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm Purity Water content Residue on ignition Nitrogen Arsenic Lead Mercury About 14 000 Content not less than 950 mg/g on the anhydrous basis White, odourless powder having a slightly sweet taste Not more than 6,0 % (Karl Fischer method) (powder form only) Not more than 1,5 % Not less than 16,8 % and not more than 17,8 % Not more than 1 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Microbiological criteria Total bacterial count Salmonellae Staphylococcus aureus Escherichia coli Not more than 5 × 104 col/g Absent in 25 g Absent in 1 g Absent in 1 g (1) Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl2·6H2O in a sufficient quantity of a mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round‐bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (1). 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl2·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl2·6H2O per ml. (2) Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round‐bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (1). 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl3·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of FeCl3·6H2O per ml. (3) Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round‐bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (1). 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO4·5H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 62,4 mg of CuSO4·5H2O per ml. (*) Starch TS: triturate 0,5 g starch (potato starch, maize starch of soluble starch) with 5 ml of water; to the resulting paste add a sufficient quantity of water to give a total volume of 100 ml, strirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be freshly prepared. (4) When labelled for food use, nitrite may only be sold in a mixture with salt or a salt substitute