Annex
United Kingdom
The Annex to Directive 95/31/EC is amended and corrected as follows:
- 1..
The following text concerning E 968 erythritol is inserted after E 967 xylitol:
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E 968 ERYTHRITOL Synonyms Meso-erythritol, tetrahydroxybutane, erythrite Definition Obtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such as Moniliella pollinis or Trichosporonoides megachilensis, followed by purification and drying Chemical name 1,2,3,4-Butanetetrol Einecs 205-737-3 Chemical formula C4H10O4 Molecular weight 122,12 Assay Not less than 99 % after drying Description White, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80 % that of sucrose. Identification A.
Solubility
Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether. B.
Melting range
119-123 °C Purity Loss on drying Not more than 0,2 % (70 °C, six hours, in a vacuum desiccator) Sulphated ash Not more than 0,1 % Reducing substances Not more than 0,3 % expressed as D-glucose Ribitol and glycerol Not more than 0,1 % Lead Not more than 0,5 mg/kg ’
- 2..
The text concerning E 954 saccharin and its Na, K and Ca salts is replaced by the following:
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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 ’
- 3..
The text concerning E 955 sucralose is replaced by the following:
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E 955 SUCRALOSE Synonyms 4,1′,6′-Trichlorogalactosucrose Definition Chemical name 1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside Einecs 259-952-2 Chemical formula C12H19Cl3O8 Molecular weight 397,64 Assay Content not less than 98 % and not more than 102 % of C12H19Cl3O8 calculated on an anhydrous basis. Description White to off-white, practically odourless crystalline powder. Identification A.
Solubility
Freely soluble in water, methanol and ethanol
Slightly soluble in ethyl acetate
B.
Infrared absorption
The infrared spectrum of a potassium bromide dispersion of the sample exhibits relative maxima at similar wave numbers as those shown in the reference spectrum obtained using a sucralose reference standard C.
Thin layer chromatography
The main spot in the test solution has the same Rf value as that of the main spot of standard solution A referred to in the test for other chlorinated disaccharides. This standard solution is obtained by dissolving 1,0 g of sucralose reference standard in 10 ml of methanol D.
Specific rotation
[α]D20 = + 84,0° to + 87,5° calculated on the anhydrous basis (10 % w/v solution) Purity Water Not more than 2,0 % (Karl Fischer method) Sulphated ash Not more than 0,7 % Other chlorinated disaccharides Not more than 0,5 % Chlorinated monosaccharides Not more than 0,1 % Triphenylphosphine oxide Not more than 150 mg/kg Methanol Not more than 0,1 % Lead Not more than 1 mg/kg ’
- 4..
The text concerning E 962 salt of aspartame-acesulfame is replaced by the following:
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E 962 SALT OF ASPARTAME-ACESULFAME Synonyms Aspartame-acesulfame, aspartame-acesulfame salt Definition The salt is prepared by heating an approximately 2:1 ratio (w/w) of aspartame and acesulfame K in solution at acidic pH and allowing crystallisation to occur. The potassium and moisture are eliminated. The product is more stable than aspartame alone Chemical name 6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phenylalanyl-2-methyl-L-α-aspartic acid Chemical formula C18H23O9N3S Molecular weight 457,46 Assay 63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37 % acesulfame (acid form on a dry basis) Description A white, odourless, crystalline powder Identification A.
Solubility
Sparingly soluble in water, slightly soluble in ethanol B.
Transmittance
The transmittance of a 1 % solution in water determined in a 1 cm cell at 430 nm with a suitable spectrophotometer using water as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022 C.
Specific rotation
[α]D20 = + 14,5° to + 16,5°
Determine at concentration of 6,2 g in 100 ml formic acid (15N) within 30 min of preparation of the solution. Divide the calculated specific rotation by 0,646 to correct for the aspartame content of the salt of aspartame-acesulfame
Purity Loss on drying Not more than 0,5 % (105 °C, four hours) 5-Benzyl-3,6-dioxo-2-piperazineacetic acid Not more than 0,5 % Lead Not more than 1 mg/kg ’
- 5..
The text concerning E 965 (i) maltitol is replaced by the following:
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E 965 (i) MALTITOL Synonyms D-Maltitol, hydrogenated maltose Definition Chemical name (α)-D-Glucopyranosyl-1,4-D-glucitol Einecs 209-567-0 Chemical formula C12H24O11 Relative molecular mass 344,31 Assay Content not less than 98 % of D-maltitol
C12H24O11 on the anhydrous basis
Description Sweet tasting, white crystalline powder Identification A.
Solubility
Very soluble in water, slightly soluble in ethanol B.
Melting range
148 to 151 °C C.
Specific rotation
[α]D20 = + 105,5° to + 108,5° (5 % w/v solution) Purity Water Not more than 1 % (Karl Fischer method) Sulphated ash Not more than 0,1 % expressed on dry weight basis Reducing sugars Not more than 0,1 % expressed as glucose on dry weight basis Chlorides Not more than 50 mg/kg expressed on dry weight basis Sulphates Not more than 100 mg/kg expressed on dry weight basis Nickel Not more than 2 mg/kg expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis ’
- 6..
The text concerning E 965 (ii) maltitol syrup is replaced by the following:
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E 965 (ii) MALTITOL SYRUP Synonyms Hydrogenated high-maltose glucose syrup, hydrogenated glucose syrup Definition A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is manufactured by the catalytic hydrogenation of high maltose-content glucose syrup or by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product Assay Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis Description Colourless and odourless, clear viscous liquids or white crystalline masses Identification A.
Solubility
Very soluble in water, slightly soluble in ethanol B.
Thin layer chromatography
Passes test Purity Water Not more than 31 % (Karl Fischer) Reducing sugars Not more than 0,3 % (as glucose) Sulphated ash Not more than 0,1 % Chlorides Not more than 50 mg/kg Sulphate Not more than 100 mg/kg Nickel Not more than 2 mg/kg Lead Not more than 1 mg/kg ’
- 7..
The text concerning E 966 lactitol is replaced by the following:
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E 966 LACTITOL Synonyms Lactit, lactositol, lactobiosit Definition Chemical name 4-O-β-D-Galactopyranosyl-D-glucitol Einecs 209-566-5 Chemical formula C12H24O11 Relative molecular mass 344,32 Assay Not less than 95 % on the dry weight basis Description Sweet-tasting crystalline powders or colourless solutions. Crystalline products occur in anhydrous, monohydrate and dihydrate forms Identification A.
Solubility
Very soluble in water B.
Specific rotation
[α]D20 = + 13° to + 16° calculated on the anhydrous basis (10 % w/v aqueous solution) Purity Water Crystalline products; not more than 10,5 % (Karl Fischer method) Other polyols Not more than 2,5 % on the anhydrous basis Reducing sugars Not more than 0,2 % expressed as glucose on dry weight basis Chlorides Not more than 100 mg/kg expressed on dry weight basis Sulphates Not more than 200 mg/kg expressed on dry weight basis Sulphated ash Not more than 0,1 % expressed on dry weight basis Nickel Not more than 2 mg/kg expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis ’