{
  "url": "https://openlegislation.uk/eu-regulation-2020-2121/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-2121/annex.json",
  "legislation": "eur/2020/2121",
  "legislation_title": "Commission Implementing Regulation (EU) 2020/2121 of 16 December 2020 concerning the authorisation of a preparation of 6-phytase produced by Komagataella phaffii DSM 32854 as a feed additive for all poultry species, ornamental birds, piglets, pigs for fattening, sows and minor porcine species for fattening or reproduction (holder of authorisation: Huvepharma EOOD) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2020-2121",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "1 FTU is the amount of enzyme that releases 1 micromole of inorganic phosphate from sodium phytate per minute under reaction conditions of pH 5,5 and 37 °C\nDetails 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\nUnits of activity/kg of complete feedingstuff with a moisture content of 12 %\nCategory of zootechnical additives. Functional group: digestibility enhancers.\n4a32\nHuvepharma EOOD\n6-phytase (EC 3.1.3.26)\nAdditive composition\nPreparation 6-phytase (EC 3.1.3.26) produced by Komagataella phaffii (DSM 32854) with a minimum activity of\n5 000 FTU/g in granular form\n5 000 FTU/g in coated form\n5 000 FTU/g in liquid form\nall poultry species\nornamental birds\npiglets\npigs for fattening\nsows\nminor porcine species for fattening or reproduction\n-\n250 FTU\n-\n1.\nIn the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.\n2.\nFor users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with protective equipment, including breathing, eye and skin protections.\n6.1.2031\nCharacterisation of the active substance\n6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii DSM 32854\nAnalytical method\nFor the quantification of phytase activity in the feed additive:\ncolorimetric method based on the enzymatic reaction of phytase on the phytate – VDLUFA 27.1.4\nFor the quantification of phytase activity in premixtures:\ncolorimetric method based on the enzymatic reaction of phytase on the phytate -VDLUFA 27.1.3\nFor the quantification of phytase activity in feed materials and compound feed:\ncolorimetric method based on the enzymatic reaction of phytase on the phytate – EN ISO 30024",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "1 FTU is the amount of enzyme that releases 1 micromole of inorganic phosphate from sodium phytate per minute under reaction conditions of pH 5,5 and 37 °C"
    },
    {
      "type": "footnote",
      "label": "f2",
      "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/2020/2121/annex",
    "retrieved_at": "2026-11-01T14:42:12.022207+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."
}