{
  "url": "https://openlegislation.uk/eu-regulation-2020-2116/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-2116/annex.json",
  "legislation": "eur/2020/2116",
  "legislation_title": "Commission Implementing Regulation (EU) 2020/2116 of 16 December 2020 concerning the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive for salmonids and its extension of use to other finfish, and repealing Regulation (EC) No 244/2007 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2020-2116",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports\nIdentification number of the additive\nName of the holder of authorisation\nAdditive\nComposition, chemical formula, description, analytical method.\nSpecies or category of animal\nMaximum age\nMinimum content\nMaximum content\nOther provisions\nEnd of period of authorisation\nmg/kg of complete feed with a moisture content of 12 %\nCategory of nutritional additives. Functional group: amino acids, their salts and analogues.\n3c351\n-\nL-histidine monohydrochloride monohydrate\nAdditive composition:\nPowder with a minimum content of\n98 % L-histidine monohydrochloride monohydrate and\n72 % histidine and\na maximum content of 100 ppm histamine\nFinfish\n-\n-\n-\n1.. L-histidine monohydrochloride monohydrate may be placed on the market and used as an additive consisting of a preparation.\n2.. In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.\n3.. Declaration to be made on the label of the additive and premixture:\n‘The supplementation with L-histidine monohydrochloride monohydrate shall be limited to the nutritional requirements of the target animal, which depend on the species, the physiological state of the animal, the performance level, the environmental conditions, the level of other amino acids in the diet and the level essential trace elements such as copper and zinc.’\nHistidine content.\n4.. For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks for the eyes and skin and by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.\n6 January 2031\nCharacterisation of the active substance:\nL-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268\nChemical formula: C3H3N2-CH2-CH(NH2)-COΟΗ· HCl· H2O\nCAS number: 5934-29-2\nEinecs number 211-438-9\nAnalytical method\nFor the quantification of histidine in the feed additive:\nhigh performance liquid chromatography coupled with photometric detection (HPLC-UV)\nion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)\nFor the quantification of histidine in premixtures, feed materials and compound feed:\nion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)\nFor the quantification of histamine in the feed additive:\nhigh performance liquid chromatography coupled to a spectrophotometric detection (HPLC-UV)",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2020/2116/annex",
    "retrieved_at": "2026-11-01T14:42:12.119472+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."
}