{
  "url": "https://openlegislation.uk/eu-directive-2006-129/annex",
  "json_url": "https://openlegislation.uk/eu-directive-2006-129/annex.json",
  "legislation": "eudr/2006/129",
  "legislation_title": "Commission Directive 2006/129/EC of 8 December 2006 amending and correcting Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2006-129",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "The Annex to Directive 96/77/EC is amended and corrected as follows:\n1.. The texts concerning E 216 propyl p-hydroxybenzoate and E 217 sodium propyl p-hydroxybenzoate are deleted.\n2.. The text concerning E 307 alpha-tocopherol is replaced by the following:\n‘\nE 307 ALPHA-TOCOPHEROL\nSynonyms\nDL-α-Tocopherol\nDefinition\nChemical name\nDL-5,7,8-Trimethyltocol\nDL-2,5,7,8-Tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol\nEinecs\n233-466-0\nChemical formula\nC29H50O2\nMolecular weight\n430,71\nAssay\nContent not less than 96 %\nDescription\nSlightly yellow to amber, nearly odourless, clear, viscous oil which oxidizes and darkens on exposure to air or light\nIdentification\nA.\nSolubility tests\nInsoluble in water, freely soluble in ethanol, miscible in ether\nB.\nSpectrophotometry\nIn absolute ethanol the maximum absorption is about 292 nm\nPurity\nRefractive index\nnD 20 1,503 to 1,507\nSpecific absorption E1 % 1 cm in ethanol\nE1 % 1 cm (292 nm) 72 to 76\n(0,01 g in 200 ml of absolute ethanol)\nSulphated ash\nNot more than 0,1 %\nSpecific rotation\n[α]25 D0° ± 0,05° (1 in 10 solution in chloroform)\nLead\nNot more than 2 mg/kg\n’\n3.. The text concerning E 315 erythorbic acid is replaced by the following:\n‘\nE 315 ERYTHORBIC ACID\nSynonyms\nIsoascorbic acid\nD-Araboascorbic acid\nDefinition\nChemical name\nD-Erythro-hex-2-enoic acid γ-lactone\nIsoascorbic acid\nD-Isoascorbic acid\nEinecs\n201-928-0\nChemical formula\nC6H8O6\nMolecular weight\n176,13\nAssay\nContent not less than 98 % on the anhydrous basis\nDescription\nWhite to slightly yellow crystalline solid which darkens gradually on exposure to light\nIdentification\nA.\nMelting range\nAbout 164 °C to 172 °C with decomposition\nB.\nPositive test for ascorbic acid/colour reaction\nPurity\nLoss on drying\nNot more than 0,4 % after drying under reduced pressure on silica gel for 3 hours\nSulphated ash\nNot more than 0,3 %\nSpecific rotation\n[α]25 D10 % (w/v) aqueous solution between – 16,5° to – 18,0°\nOxalate\nTo 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\nLead\nNot more than 2 mg/kg\n’\n4.. The following text concerning E 319 tertiary-butylhydroquinone (TBHQ) is inserted after E 316 sodium erythorbate:\n‘\nE 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)\nSynonyms\nTBHQ\nDefinition\nChemical names\nTert-butyl-1,4-benzenediol\n2-(1,1-Dimethylethyl)-1,4-benzenediol\nEinecs\n217-752-2\nChemical formula\nC10H14O2\nMolecular weight\n166,22\nAssay\nContent not less than 99 % of C10H14O2\nDescription\nWhite crystalline solid having a characteristic odour\nIdentification\nA.\nSolubility\nPractically insoluble in water; soluble in ethanol\nB.\nMelting point\nNot less than 126,5 °C\nC.\nPhenolics\nDissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced\nPurity\nTertiary-Butyl-p-benzoquinone\nNot more than 0,2 %\n2,5-Di-tertiary-butyl hydroquinone\nNot more than 0,2 %\nHydroxyquinone\nNot more than 0,1 %\nToluene\nNot more than 25 mg/kg\nLead\nNot more than 2 mg/kg\n’\n5.. The text concerning E 415 xanthan gum is replaced by the following:\n‘\nE 415 XANTHAN GUM\nDefinition\nXanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with natural strains of Xanthomonas campestris, purified by recovery with ethanol or propan-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral\nMolecular weight\nApproximately 1 000 000\nEinecs\n234-394-2\nAssay\nYields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gum\nDescription\nCream-coloured powder\nIdentification\nA.\nSolubility\nSoluble in water. Insoluble in ethanol\nPurity\nLoss on drying\nNot more than 15 % (105 °C, 21/2hours)\nTotal ash\nNot more than 16 % on the anhydrous basis determined at 650 °C after drying at 105 °C for four hours\nPyruvic acid\nNot less than 1,5 %\nNitrogen\nNot more than 1,5 %\nEthanol and propan-2-ol\nNot more than 500 mg/kg singly or in combination\nLead\nNot more than 2 mg/kg\nTotal plate count\nNot more than 5 000 colonies per gram\nYeast and mould\nNot more than 300 colonies per gram\nE. coli\nAbsent in 5 g\nSalmonella spp.\nAbsent in 10 g\nXanthomonas campestris\nViable cells absent in 1 g\n’\n6.. The following text concerning E 426 soybean hemicellulose is inserted after E 425(ii) konjac glucomannan:\n‘\nE 426 SOYBEAN HEMICELLULOSE\nSynonyms\nDefinition\nSoybean hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extraction\nChemical names\nWater soluble soybean polysaccharides\nWater soluble soybean fibre\nAssay\nNot less than 74 % carbohydrate\nDescription\nFree flowing spray-dried white powder\nIdentification\nA.\nSolubility\nSoluble in hot and cold water without gel formation\npH of 1 % solution\n5,5 ± 1,5\nB.\nViscosity of 10 % solution\nNot more than 200 mPa.s\nPurity\nLoss on drying\nNot more than 7 % (105 °C, 4 h)\nProtein\nNot more than 14 %\nTotal ash\nNot more than 9,5 % (600 °C, 4 h)\nArsenic\nNot more than 2 mg/kg\nLead\nNot more than 5 mg/kg\nMercury\nNot more than 1 mg/kg\nCadmium\nNot more than 1 mg/kg\nStandard plate count\nNot more than 3 000 colonies per gram\nYeast and mould\nNot more than 100 colonies per gram\nE. Coli\nNegative in 10 g\n’\n7.. The following text concerning E 462 ethyl cellulose is inserted after E 461 methyl cellulose:\n‘\nE 462 ETHYL CELLULOSE\nSynonyms\nCellulose ethyl ether\nDefinition\nEthyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groups\nChemical names\nEthyl ether of cellulose\nChemical formula\nThe polymers contain substituted anhydroglucose units with the following general formula:\nC6H7O2(OR1)(OR2) where R1 and R2 may be any of the following:\nH\nCH2CH3\nAssay\nContent not less than 44 % and not more than 50 % of ethoxyl groups (-OC2H5) on the dried basis (equivalent to not more than 2,6 ethoxyl groups per anhydroglucose unit)\nDescription\nSlightly hygroscopic, white to off white, odourless and tasteless powder\nIdentification\nA.\nSolubility\nPractically insoluble in water, in glycerol and in propane-1,2-diol but soluble in varying proportions in certain organic solvents depending upon the ethoxyl content. Ethyl cellulose containing less than 46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydrocarbon ethanol mixtures. Ethyl cellulose containing 46 to 48 % or more of ethoxyl groups is freely soluble in ethanol, in methanol, in toluene, in chloroform and in ethyl acetate\nB.\nFilm forming test\nDissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of toluene ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml of the solution onto a glass plate and allow the solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable\nPurity\nLoss on drying\nNot more than 3 % (105 °C, 2 h)\nSulphated ash\nNot more than 0,4 %\npH of a 1 % colloidal solution\nNeutral to litmus\nArsenic\nNot more than 3 mg/kg\nLead\nNot more than 2 mg/kg\nMercury\nNot more than 1 mg/kg\nCadmium\nNot more than 1 mg/kg\n’\n8.. The text concerning E 472c citric acid esters of mono- and diglycerides of fatty acids is replaced by the following:\n‘\nE 472c CITRIC ACID ESTERS OF MONO- AND DIGLYCYERIDES OF FATTY ACIDS\nSynonyms\nCitrem\nCitric acid esters of mono- and diglycerides\nCitroglycerides\nMono- and diglycerides of fatty acids esterified with citric acid\nDefinition\nEsters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium hydroxide or with potassium hydroxide\nDescription\nYellowish or light brown liquids to waxy solids or semi-solids\nIdentification\nA.\nPositive test for glycerol, for fatty acids and for citric acid\nB.\nSolubility\nInsoluble in cold water\nDispersible in hot water\nSoluble in oils and fats\nIn soluble in cold ethanol\nPurity\nAcids other than citric and fatty acids\nNot detectable\nFree glycerol\nNot more than 2 %\nTotal glycerol\nNot less than 8 % and not more than 33 %\nTotal citric acid\nNot less than 13 % and not more than 50 %\nSulphated ash (determined at 800 ± 25 °C)\nNon-neutralised products: not more than 0,5 %\nPartially or wholly neutralised products: not more than 10 %\nLead\nNot more than 2 mg/kg\nFree fatty acids\nNot more than 3 % estimated as oleic acid\nPurity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).\n’\n9.. The text concerning E 559 aluminium silicate (kaolin) is replaced by the following:\n‘\nE 559 ALUMINIUM SILICATE (KAOLIN)\nSynonyms\nKaolin, light or heavy\nDefinition\nAluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption\nEinecs\n215-286-4 (kaolinite)\nChemical formula\nAl2Si2O5(OH)4 (kaolinite)\nMolecular weight\n264\nAssay\nContent not less than 90 % (sum of silica and alumina, after ignition)\nSilica (SiO2) Between 45 % and 55 %\nAlumina (A12O3) Between 30 % and 39 %\nDescription\nFine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes.\nIdentification\nA.\nPositive test for alumina and for silicate\nB.\nX-ray diffraction\nCharacteristic peaks at 7,18/3,58/2,38/1,78 Å\nC.\nIR absorption\nPeaks at 3 700 and 3 620 cm–1\nPurity\nLoss on ignition\nBetween 10 and 14 % (1 000 °C, constant weight)\nWater soluble matter\nNot more than 0,3 %\nAcid soluble matter\nNot more than 2 %\nIron\nNot more than 5 %\nPotassium oxide (K2O)\nNot more than 5 %\nCarbon\nNot more than 0,5 %\nArsenic\nNot more than 3 mg/kg\nLead\nNot more than 5 mg/kg\nMercury\nNot more than 1 mg/kg\n’\n10.. The following text concerning E 586 4-hexylresorcinol is inserted after E 578 calcium gluconate:\n‘\nE 586 4-HEXYLRESORCINOL\nSynonyms\n4-Hexyl-1,3-benzenediol\nHexylresorcinol\nDefinition\nChemical names\n4-Hexylresorcinol\nEinecs\n205-257-4\nChemical formula\nC12H18O2\nMolecular weight\n197,24\nAssay\nNot less than 98,0 % on the dried basis\nDescription\nWhite powder\nIdentification\nA.\nSolubility\nFreely soluble in ether and acetone; very slightly soluble in water\nB.\nNitric acid test\nTo 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears\nC.\nBromine test\nTo 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution\nD.\nMelting range\n62 to 67 °C\nPurity\nAcidity\nNot more than 0,05 %\nSulphated ash\nNot more than 0,1 %\nResorcinol and other phenols\nShake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is produced\nNickel\nNot more than 2 mg/kg\nLead\nNot more than 2 mg/kg\nMercury\nNot more than 3 mg/kg\n’\n11.. The following text concerning E 1204 pullulan is inserted after E 1200 polydextrose:\n‘\nE 1204 PULLULAN\nDefinition\nLinear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food grade hydrolysed starch using a non-toxin producing strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography\nEinecs\n232-945-1\nChemical formula\n(C6H10O5)x\nAssay\nNot less than 90 % of glucan on the dried basis\nDescription\nWhite to off-white odourless powder\nIdentification\nA.\nSolubility\nSoluble in water, practically insoluble in ethanol.\nB.\npH of 10 % solution\n5,0 to 7,0\nC.\nPrecipitation with polyethylene glycol 600\nAdd 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed\nD.\nDepolymerisation with pullulanase\nPrepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1 ml pullulanase solution having activity 10 units/g to one test tube, and 0,1 ml water to the other. After incubation at about 25 °C for 20 min, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution\nPurity\nLoss on drying\nNot more than 6 % (90 °C, pressure not more than 50 mm Hg, 6 h)\nMono-, di- and oligosaccharides\nNot more than 10 % expressed as glucose\nViscosity\n100 to 180 mm2/s (10 % w/w aqueous solution at 30 °C)\nLead\nNot more than 1 mg/kg\nYeast and moulds\nNot more than 100 colonies per gram\nColiforms\nAbsent in 25 g\nSalmonella\nAbsent in 25 g\n’\n12.. The following text concerning E 1452 starch aluminium octenyl succinate is inserted after E 1451 acetylated oxidised starch:\n‘\nE 1452 STARCH ALUMINIUM OCTENYL SUCCINATE\nSynonyms\nSAOS\nDefinition\nStarch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate\nDescription\nWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles\nIdentification\nA.\nIf not pregelatinised: by miscroscopic observation\nB.\nIodine staining positive (dark blue to light red colour)\nPurity\n(all values expressed on an anhydrous basis except for loss on drying)\nLoss on drying\nNot more than 21 %\nOctenylsuccinyl groups\nNot more than 3 %\nOctenylsuccinic acid residue\nNot more than 0,3 %\nSulphur dioxide\nNot more than 50 mg/kg for modified cereal starches\nNot more than 10 mg/kg for the other modified starches unless otherwise specified\nArsenic\nNot more than 1 mg/kg\nLead\nNot more than 2 mg/kg\nMercury\nNot more than 0,1 mg/kg\nAluminium\nNot more than 0,3 %\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/2006/129/annex",
    "retrieved_at": "2026-11-01T15:22:29.573318+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."
}