{
  "url": "https://openlegislation.uk/eu-directive-2006-128/annex",
  "json_url": "https://openlegislation.uk/eu-directive-2006-128/annex.json",
  "legislation": "eudr/2006/128",
  "legislation_title": "Commission Directive 2006/128/EC of 8 December 2006 amending and correcting Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2006-128",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "The Annex to Directive 95/31/EC is amended and corrected as follows:\n1.. The following text concerning E 968 erythritol is inserted after E 967 xylitol:\n‘\nE 968 ERYTHRITOL\nSynonyms\nMeso-erythritol, tetrahydroxybutane, erythrite\nDefinition\nObtained 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\nChemical name\n1,2,3,4-Butanetetrol\nEinecs\n205-737-3\nChemical formula\nC4H10O4\nMolecular weight\n122,12\nAssay\nNot less than 99 % after drying\nDescription\nWhite, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80 % that of sucrose.\nIdentification\nA.\nSolubility\nFreely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether.\nB.\nMelting range\n119-123 °C\nPurity\nLoss on drying\nNot more than 0,2 % (70 °C, six hours, in a vacuum desiccator)\nSulphated ash\nNot more than 0,1 %\nReducing substances\nNot more than 0,3 % expressed as D-glucose\nRibitol and glycerol\nNot more than 0,1 %\nLead\nNot more than 0,5 mg/kg\n’\n2.. The text concerning E 954 saccharin and its Na, K and Ca salts is replaced by the following:\n‘\nE 954 SACCHARIN AND ITS Na, K AND Ca SALTS\n(I) SACCHARIN\nDefinition\nChemical name\n3-Oxo-2,3-dihydrobenzo(d)isothiazol-1,1-dioxide\nEinecs\n201-321-0\nChemical formula\nC7H5NO3S\nRelative molecular mass\n183,18\nAssay\nNot less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis\nDescription\nWhite 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\nIdentification\nSolubility\nSlightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol\nPurity\nLoss on drying\nNot more than 1 % (105 °C, two hours)\nMelting range\n226-230 °C\nSulphated ash\nNot more than 0,2 % expressed on dry weight basis\nBenzoic and salicylic acid\nTo 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\no-Toluenesulphonamide\nNot more than 10 mg/kg expressed on dry weight basis\np-Toluenesulphonamide\nNot more than 10 mg/kg expressed on dry weight basis\nBenzoic acid p-sulfonamide\nNot more than 25 mg/kg expressed on dry weight basis\nReadily carbonisable substances\nAbsent\nArsenic\nNot more than 3 mg/kg expressed on dry weight basis\nSelenium\nNot more than 30 mg/kg expressed on dry weight basis\nLead\nNot more than 1 mg/kg expressed on dry weight basis.\n(II) SODIUM SACCHARIN\nSynonyms\nSaccharin, sodium salt of saccharin\nDefinition\nChemical name\nSodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole, oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide sodium salt dihydrate\nEinecs\n204-886-1\nChemical formula\nC7H4NNaO3S·2H2O\nRelative molecular mass\n241,19\nAssay\nNot less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis\nDescription\nWhite 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\nIdentification\nSolubility\nFreely soluble in water, sparingly soluble in ethanol\nPurity\nLoss on drying\nNot more than 15 % (120 °C, four hours)\nBenzoic and salicylic acid\nTo 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\no-Toluenesulphonamide\nNot more than 10 mg/kg expressed on dry weight basis\np-Toluenesulphonamide\nNot more than 10 mg/kg expressed on dry weight basis\nBenzoic acid p-sulphonamide\nNot more than 25 mg/kg expressed on dry weight basis\nReadily carbonisable substances\nAbsent\nArsenic\nNot more than 3 mg/kg expressed on dry weight basis\nSelenium\nNot more than 30 mg/kg expressed on dry weight basis\nLead\nNot more than 1 mg/kg expressed on dry weight basis\n(III) CALCIUM SACCHARIN\nSynonyms\nSaccharin, calcium salt of saccharin\nDefinition\nChemical name\nCalcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulfonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)\nEinecs\n229-349-9\nChemical formula\nC14H8CaN2O6S2·31/2H2O\nRelative molecular mass\n467,48\nAssay\nNot less than 95 % of C14H8CaN2O6S2 on the anhydrous basis\nDescription\nWhite 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\nIdentification\nSolubility\nFreely soluble in water, soluble in ethanol\nPurity\nLoss on drying\nNot more than 13,5 % (120 °C, four hours)\nBenzoic and salicylic acid\nTo 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\no-Toluenesulphonamide\nNot more than 10 mg/kg expressed on dry weight basis\np-Toluenesulphonamide\nNot more than 10 mg/kg expressed on dry weight basis\nBenzoic acid p-sulphonamide\nNot more than 25 mg/kg expressed on dry weight basis\nReadily carbonisable substances\nAbsent\nArsenic\nNot more than 3 mg/kg expressed on dry weight basis\nSelenium\nNot more than 30 mg/kg expressed on dry weight basis\nLead\nNot more than 1 mg/kg expressed on dry weight basis\n(IV) POTASSIUM SACCHARIN\nSynonyms\nSaccharin, potassium salt of saccharin\nDefinition\nChemical name\nPotassium o-benzosulphimide, potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate\nEinecs\nChemical formula\nC7H4KNO3S·H2O\nRelative molecular mass\n239,77\nAssay\nNot less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis\nDescription\nWhite 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\nIdentification\nSolubility\nFreely soluble in water, sparingly soluble in ethanol\nPurity\nLoss on drying\nNot more than 8 % (120 °C, four hours)\nBenzoic and salicylic acid\nTo 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\no-Toluenesulphonamide\nNot more than 10 mg/kg expressed on dry weight basis\np-Toluenesulphonamide\nNot more than 10 mg/kg expressed on dry weight basis\nBenzoic acid p-sulphonamide\nNot more than 25 mg/kg expressed on dry weight basis\nReadily carbonisable substances\nAbsent\nArsenic\nNot more than 3 mg/kg expressed on dry weight basis\nSelenium\nNot more than 30 mg/kg expressed on dry weight basis\nLead\nNot more than 1 mg/kg expressed on dry weight basis\n’\n3.. The text concerning E 955 sucralose is replaced by the following:\n‘\nE 955 SUCRALOSE\nSynonyms\n4,1′,6′-Trichlorogalactosucrose\nDefinition\nChemical name\n1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside\nEinecs\n259-952-2\nChemical formula\nC12H19Cl3O8\nMolecular weight\n397,64\nAssay\nContent not less than 98 % and not more than 102 % of C12H19Cl3O8 calculated on an anhydrous basis.\nDescription\nWhite to off-white, practically odourless crystalline powder.\nIdentification\nA.\nSolubility\nFreely soluble in water, methanol and ethanol\nSlightly soluble in ethyl acetate\nB.\nInfrared absorption\nThe 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\nC.\nThin layer chromatography\nThe 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\nD.\nSpecific rotation\n[α]D20 = + 84,0° to + 87,5° calculated on the anhydrous basis (10 % w/v solution)\nPurity\nWater\nNot more than 2,0 % (Karl Fischer method)\nSulphated ash\nNot more than 0,7 %\nOther chlorinated disaccharides\nNot more than 0,5 %\nChlorinated monosaccharides\nNot more than 0,1 %\nTriphenylphosphine oxide\nNot more than 150 mg/kg\nMethanol\nNot more than 0,1 %\nLead\nNot more than 1 mg/kg\n’\n4.. The text concerning E 962 salt of aspartame-acesulfame is replaced by the following:\n‘\nE 962 SALT OF ASPARTAME-ACESULFAME\nSynonyms\nAspartame-acesulfame, aspartame-acesulfame salt\nDefinition\nThe 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\nChemical name\n6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phenylalanyl-2-methyl-L-α-aspartic acid\nChemical formula\nC18H23O9N3S\nMolecular weight\n457,46\nAssay\n63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37 % acesulfame (acid form on a dry basis)\nDescription\nA white, odourless, crystalline powder\nIdentification\nA.\nSolubility\nSparingly soluble in water, slightly soluble in ethanol\nB.\nTransmittance\nThe 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\nC.\nSpecific rotation\n[α]D20 = + 14,5° to + 16,5°\nDetermine 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\nPurity\nLoss on drying\nNot more than 0,5 % (105 °C, four hours)\n5-Benzyl-3,6-dioxo-2-piperazineacetic acid\nNot more than 0,5 %\nLead\nNot more than 1 mg/kg\n’\n5.. The text concerning E 965 (i) maltitol is replaced by the following:\n‘\nE 965 (i) MALTITOL\nSynonyms\nD-Maltitol, hydrogenated maltose\nDefinition\nChemical name\n(α)-D-Glucopyranosyl-1,4-D-glucitol\nEinecs\n209-567-0\nChemical formula\nC12H24O11\nRelative molecular mass\n344,31\nAssay\nContent not less than 98 % of D-maltitol\nC12H24O11 on the anhydrous basis\nDescription\nSweet tasting, white crystalline powder\nIdentification\nA.\nSolubility\nVery soluble in water, slightly soluble in ethanol\nB.\nMelting range\n148 to 151 °C\nC.\nSpecific rotation\n[α]D20 = + 105,5° to + 108,5° (5 % w/v solution)\nPurity\nWater\nNot more than 1 % (Karl Fischer method)\nSulphated ash\nNot more than 0,1 % expressed on dry weight basis\nReducing sugars\nNot more than 0,1 % expressed as glucose on dry weight basis\nChlorides\nNot more than 50 mg/kg expressed on dry weight basis\nSulphates\nNot more than 100 mg/kg expressed on dry weight basis\nNickel\nNot more than 2 mg/kg expressed on dry weight basis\nArsenic\nNot more than 3 mg/kg expressed on dry weight basis\nLead\nNot more than 1 mg/kg expressed on dry weight basis\n’\n6.. The text concerning E 965 (ii) maltitol syrup is replaced by the following:\n‘\nE 965 (ii) MALTITOL SYRUP\nSynonyms\nHydrogenated high-maltose glucose syrup, hydrogenated glucose syrup\nDefinition\nA 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\nAssay\nContent not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis\nDescription\nColourless and odourless, clear viscous liquids or white crystalline masses\nIdentification\nA.\nSolubility\nVery soluble in water, slightly soluble in ethanol\nB.\nThin layer chromatography\nPasses test\nPurity\nWater\nNot more than 31 % (Karl Fischer)\nReducing sugars\nNot more than 0,3 % (as glucose)\nSulphated ash\nNot more than 0,1 %\nChlorides\nNot more than 50 mg/kg\nSulphate\nNot more than 100 mg/kg\nNickel\nNot more than 2 mg/kg\nLead\nNot more than 1 mg/kg\n’\n7.. The text concerning E 966 lactitol is replaced by the following:\n‘\nE 966 LACTITOL\nSynonyms\nLactit, lactositol, lactobiosit\nDefinition\nChemical name\n4-O-β-D-Galactopyranosyl-D-glucitol\nEinecs\n209-566-5\nChemical formula\nC12H24O11\nRelative molecular mass\n344,32\nAssay\nNot less than 95 % on the dry weight basis\nDescription\nSweet-tasting crystalline powders or colourless solutions. Crystalline products occur in anhydrous, monohydrate and dihydrate forms\nIdentification\nA.\nSolubility\nVery soluble in water\nB.\nSpecific rotation\n[α]D20 = + 13° to + 16° calculated on the anhydrous basis (10 % w/v aqueous solution)\nPurity\nWater\nCrystalline products; not more than 10,5 % (Karl Fischer method)\nOther polyols\nNot more than 2,5 % on the anhydrous basis\nReducing sugars\nNot more than 0,2 % expressed as glucose on dry weight basis\nChlorides\nNot more than 100 mg/kg expressed on dry weight basis\nSulphates\nNot more than 200 mg/kg expressed on dry weight basis\nSulphated ash\nNot more than 0,1 % expressed on dry weight basis\nNickel\nNot more than 2 mg/kg expressed on dry weight basis\nArsenic\nNot more than 3 mg/kg expressed on dry weight basis\nLead\nNot more than 1 mg/kg expressed on dry weight basis\n’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2006/128/annex",
    "retrieved_at": "2026-11-01T15:22:29.617008+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}