{
  "url": "https://openlegislation.uk/eu-decision-2017-1281/annex-I/division-2",
  "json_url": "https://openlegislation.uk/eu-decision-2017-1281/annex-I/division-2.json",
  "legislation": "eudn/2017/1281",
  "legislation_title": "Commission Implementing Decision (EU) 2017/1281 of 13 July 2017 authorising the placing on the market of L-ergothioneine as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 4844) (Only the English text is authentic)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2017-1281",
  "path": "annex/I/division/2",
  "kind": "division",
  "number": null,
  "heading": "Specifications",
  "text": "Lit. [α]D = (+) 126,6° (c = 1, H20)\nAnalyses conducted on each batch\nMaximum levels in accordance with Commission Regulation (EC) No 1881/2006 (OJ L 364, 20.12.2006, p. 5).\nEur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC: gel permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy;\nCFU: colony-forming units.\nParameter\nSpecification\nMethod\nAppearance\nWhite powder\nVisual\nOptical rotation\n[α]D ≥ (+) 122° (c = 1, H20)\nPolarimetry\nChemical purity\n≥ 99,5 %\nHPLC [Eur. Ph. 2.2.29]\n≥ 99 %\n1H-NMR\nIdentification\nCompliant with the structure\n1H-NMR\nC: 47,14 ± 0,4 %\nH: 6,59 ± 0,4 %\nN: 18,32 ± 0,4 %\nElemental analysis\nTotal residual solvents\n(methanol, ethyl acetate, isopropanol, ethanol)\n[Eur. Ph. 01/2008:50400]\n< 1 000 ppm\nGas chromatography\n[Eur. Ph. 01/2008:20424]\nLoss on drying\nInternal standard < 0,5 %\n[Eur. Ph. 01/2008:20232]\nImpurities\n< 0,8 %\nHPLC/GPC or 1H-NMR\nHeavy metals\nLead\n< 3 ppm\nICP/AES\n(Pb, Cd)\nAtomic fluorescence (Hg)\nCadmium\n< 1 ppm\nMercury\n< 0,1 ppm\nMicrobiological specifications\nTotal viable aerobic count (TVAC)\n≤ 1 × 103 CFU/g\n[Eur. Ph. 01/2011:50104]\nTotal yeast and mould count (TYMC)\n≤ 1 × 102 CFU/g\nEscherichia coli\nAbsent in 1 g",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Lit. [α]D = (+) 126,6° (c = 1, H20)"
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Analyses conducted on each batch"
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Maximum levels in accordance with Commission Regulation (EC) No 1881/2006 (OJ L 364, 20.12.2006, p. 5)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2017/1281/annex/I/division/2",
    "retrieved_at": "2026-11-01T15:13:25.599273+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."
}