{
  "url": "https://openlegislation.uk/eu-regulation-2018-1461/annex-II",
  "json_url": "https://openlegislation.uk/eu-regulation-2018-1461/annex-II.json",
  "legislation": "eur/2018/1461",
  "legislation_title": "Commission Regulation (EU) 2018/1461 of 28 September 2018 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the use of Low-substituted hydroxypropyl cellulose (L-HPC) in food supplements (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2018-1461",
  "path": "annex/II",
  "kind": "annex",
  "number": "II",
  "heading": null,
  "text": "In the Annex to Regulation (EU) No 231/2012 the following entry for E 463a (Low-substituted hydroxypropyl cellulose (L-HPC)) is inserted after the entry for E 463 (Hydroxypropyl cellulose):\n‘\nE 463a LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (L-HPC)\nSynonyms\nCellulose hydroxypropyl ether, low substituted\nDefinition\nL-HPC is a low-substituted poly (hydroxypropyl) ether of cellulose.\nL-HPC is manufactured by partial etherification of the anhydroglucose units of pure cellulose (wood pulp) with propylene oxide/hydroxypropyl groups. The resulting product is then purified, dried and milled to yield low-substituted hydroxypropyl cellulose.\nL-HPC contains not less than 5,0 % and not more than 16,0 % of hydroxypropoxy groups, calculated on the dried basis.\nL-HPC differs from hydroxypropyl cellulose (E 463) with respect to the degree of molar substitution with hydroxypropoxy groups of the glucose ring unit (0,2 for L-HPC vs 3,5 for E 463) of the cellulose backbone.\nIUPAC name\nCellulose, 2-hydroxypropyl ether (low substituted)\nCAS number\n9004-64-2\nEinecs number\nChemical name\nHydroxypropyl ether of cellulose, low-substituted\nChemical formula\nThe polymers contain substituted anhydroglucose units with the following general formula:\nC6H7O2(OR1)(OR2)(OR3)\nwhere R1, R2, R3 each may be one of the following:\nH\nCH2CHOHCH3\nCH2CHO(CH2CHOHCH3)CH3\nCH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3\nMolecular weight\nFrom about 30 000 to 150 000 g/mol\nAssay\nThe average number of hydroxypropoxy groups\n(–OCH2CHOHCH3) corresponds to 0,2 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis\nParticle size\nby laser diffraction method — Not less than 45 μm (not more than 1 % in weight of particles of less than 45 μm) and not more than 65 μm\nby size-exclusion chromatography (SEC) — Average (D50) particle size between 47,3 μm and 50,3 μm; D90 value (90 % below given value) between 126,2 μm and 138 μm\nDescription\nSlightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder\nIdentification\nPasses test\nSolubility\nInsoluble in water; swelling in water. It dissolves in a solution of 10 % sodium hydroxide producing a viscous solution.\nAssay\nDetermination of the degree of molar substitution by gas chromatography\npH\nNot less than 5,0 and not more than 7,5 (1 % colloidal suspension)\nPurity\nLoss on drying\nNot more than 5,0 % (105 °C, 1 hour)\nResidue on ignition\nNot more than 0,8 % determined at 800 °C ± 25 °C\nPropylene chlorohydrins\nNot more than 0,1 mg/kg (on an anhydrous basis) (gas chromatography–mass spectrometry (GC–MS))\nArsenic\nNot more than 2 mg/kg\nLead\nNot more than 1 mg/kg\nMercury\nNot more than 0,5 mg/kg\nCadmium\nNot more than 0,15 mg/kg\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/eur/2018/1461/annex/II",
    "retrieved_at": "2026-11-01T14:43:56.514636+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."
}