2.

The text concerning E 954 saccharin and its Na, K and Ca salts is replaced by the following: ‘E 954 SACCHARIN AND ITS Na, K AND Ca SALTS (I) SACCHARIN Definition Chemical name 3-Oxo-2,3-dihydrobenzo(d)isothiazol-1,1-dioxide Einecs 201-321-0 Chemical formula C7H5NO3S Relative molecular mass 183,18 Assay Not less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis Description White crystals or a white crystalline powder, odourless or with a faint, aromatic odour, having a sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose Identification Solubility Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol Purity Loss on drying Not more than 1 % (105 °C, two hours) Melting range 226-230 °C Sulphated ash Not more than 0,2 % expressed on dry weight basis Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis Benzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basis Readily carbonisable substances Absent Arsenic Not more than 3 mg/kg expressed on dry weight basis Selenium Not more than 30 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis. (II) SODIUM SACCHARIN Synonyms Saccharin, sodium salt of saccharin Definition Chemical name Sodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole, oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide sodium salt dihydrate Einecs 204-886-1 Chemical formula C7H4NNaO3S·2H2O Relative molecular mass 241,19 Assay Not less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis Description White crystals or a white crystalline efflorescent powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions Identification Solubility Freely soluble in water, sparingly soluble in ethanol Purity Loss on drying Not more than 15 % (120 °C, four hours) Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis Benzoic acid p-sulphonamide Not more than 25 mg/kg expressed on dry weight basis Readily carbonisable substances Absent Arsenic Not more than 3 mg/kg expressed on dry weight basis Selenium Not more than 30 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis (III) CALCIUM SACCHARIN Synonyms Saccharin, calcium salt of saccharin Definition Chemical name Calcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulfonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7) Einecs 229-349-9 Chemical formula C14H8CaN2O6S2·31/2H2O Relative molecular mass 467,48 Assay Not less than 95 % of C14H8CaN2O6S2 on the anhydrous basis Description White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions Identification Solubility Freely soluble in water, soluble in ethanol Purity Loss on drying Not more than 13,5 % (120 °C, four hours) Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis Benzoic acid p-sulphonamide Not more than 25 mg/kg expressed on dry weight basis Readily carbonisable substances Absent Arsenic Not more than 3 mg/kg expressed on dry weight basis Selenium Not more than 30 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis (IV) POTASSIUM SACCHARIN Synonyms Saccharin, potassium salt of saccharin Definition Chemical name Potassium o-benzosulphimide, potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate Einecs Chemical formula C7H4KNO3S·H2O Relative molecular mass 239,77 Assay Not less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis Description White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose Identification Solubility Freely soluble in water, sparingly soluble in ethanol Purity Loss on drying Not more than 8 % (120 °C, four hours) Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis Benzoic acid p-sulphonamide Not more than 25 mg/kg expressed on dry weight basis Readily carbonisable substances Absent Arsenic Not more than 3 mg/kg expressed on dry weight basis Selenium Not more than 30 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis’