{
  "url": "https://openlegislation.uk/eu-directive-2009-41/annex-IV/division-CONTAINMENT",
  "json_url": "https://openlegislation.uk/eu-directive-2009-41/annex-IV/division-CONTAINMENT.json",
  "legislation": "eudr/2009/41",
  "legislation_title": "Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2009-41",
  "path": "annex/IV/division/CONTAINMENT",
  "kind": "division",
  "number": "CONTAINMENT AND OTHER PROTECTIVE MEASURES",
  "heading": "General principles",
  "text": "Table I A\nContainment and other protective measures for laboratory activities\nIsolation the laboratory is separated from other areas in the same building or is in a separate building.\nAirlock entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.\nActivities where transmission does not occur via airborne route.\nHEPA High efficiency particulate air.\nWhere viruses which are not retained by HEPA filters are used, extra requirements will be necessary for extract air.\nWith validated procedures, allowing the safe transfer of material into an autoclave outside the lab, and providing an equivalent level of protection.\nSpecifications\nContainment levels\n1\n2\n3\n4\n1\nLaboratory suite: isolation\nNot required\nNot required\nRequired\nRequired\n2\nLaboratory: sealable for fumigation\nNot required\nNot required\nRequired\nRequired\nEquipment\n3\nSurfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents, and easy to clean\nRequired (bench)\nRequired (bench)\nRequired (bench, floor)\nRequired (bench, floor, ceiling, walls)\n4\nEntry to lab via airlock\nNot required\nNot required\nOptional\nRequired\n5\nNegative pressure relative to the pressure of the immediate environment\nNot required\nNot required\nRequired except for\nRequired\n6\nExtract and input air from the laboratory should be HEPA-filtered\nNot required\nNot required\nRequired (HEPA — extract air except for)\nRequired (HEPA— input and extract air)\n7\nMicrobiological safety post\nNot required\nOptional\nRequired\nRequired\n8\nAutoclave\nOn site\nIn the building\nEn suite\nIn lab = double-ended\nSystem of work\n9\nRestricted access\nNot required\nRequired\nRequired\nRequired\n10\nBiohazard sign on the door\nNot required\nRequired\nRequired\nRequired\n11\nSpecific measures to control aerosol dissemination\nNot required\nRequired minimise\nRequired prevent\nRequired prevent\n13\nShower\nNot required\nNot required\nOptional\nRequired\n14\nProtective clothing\nSuitable protective clothing\nSuitable protective clothing\nSuitable protective clothing and (optional) footwear\nComplete change of clothing and footwear before entry and exit\n15\nGloves\nNot required\nOptional\nRequired\nRequired\n18\nEfficient vector control (e.g. for rodents and insects)\nOptional\nRequired\nRequired\nRequired\nWaste\n19\nInactivation of GMMs in effluent from hand-washing sinks or drains and showers and similar effluents\nNot required\nNot required\nOptional\nRequired\n20\nInactivation of GMMs in contaminated material and waste\nOptional\nRequired\nRequired\nRequired\nOther measures\n21\nLaboratory to contain its own equipment\nNot required\nNot required\nOptional\nRequired\n23\nAn observation window or alternative is to be present so that occupants can be seen\nOptional\nOptional\nOptional\nRequired\nTable I B\nContainment and other protective measures for glasshouses and growth-rooms\nThe terms ‘glasshouse’ and ‘growth-room’ refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment.\nAll provisions of Table I A shall apply with the following additions/modifications:\nThe glasshouse shall consist of a permanent structure with a continuous waterproof covering, located on a site graded to prevent entry of surface-water run-off, and with self-closing lockable doors.\nWhere transmission can occur through the ground.\nSpecifications\nContainment levels\n1\n2\n3\n4\nBuilding\n1\nGlasshouse: permanent structure\nNot required\nRequired\nRequired\nRequired\nEquipment\n3\nEntry via a separate room with two interlocking doors\nNot required\nOptional\nOptional\nRequired\n4\nControl of contaminated run-off water\nOptional\nMinimise run-off\nPrevent run-off\nPrevent run-off\nSystem of work\n6\nMeasures to control undesired species such as insects, rodents, arthropods\nRequired\nRequired\nRequired\nRequired\n7\nProcedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of GMMs\nMinimise dissemination\nMinimise dissemination\nPrevent dissemination\nPrevent dissemination\nTable I C\nContainment and other protective measures for activities in animal units\nAll provisions of Table I A shall apply with the following additions/modifications:\nAnimal unit a building or separate area within a building containing facilities and other areas such as changing rooms, showers, autoclaves, food storage areas, etc.\nAnimal facility a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures.\nIsolators transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate.\nSpecifications\nContainment levels\n1\n2\n3\n4\nFacilities\n1\nIsolation of animal unit\nOptional\nRequired\nRequired\nRequired\n2\nAnimal facilities separated by lockable doors\nOptional\nRequired\nRequired\nRequired\n3\nAnimal facilities designed to facilitate decontamination (waterproof and easily washable material (cages, etc.))\nOptional\nOptional\nRequired\nRequired\n4\nFloor and/or walls easily washable\nOptional\nRequired (floor)\nRequired (floor and walls)\nRequired (floor and walls)\n5\nAnimals kept in appropriate containment facilities such as cages, pens or tanks\nOptional\nOptional\nOptional\nOptional\n6\nFilters on isolators or isolated room\nNot required\nOptional\nRequired\nRequired\nTable II\nContainment and other protective measures for other activities\nSpecifications\nContainment levels\n1\n2\n3\n4\nGeneral\n1\nViable micro-organisms should be contained in a system which separates the process from the environment (closed system)\nOptional\nRequired\nRequired\nRequired\n2\nControl of exhaust gases from the closed system\nNot required\nRequired, minimise dissemination\nRequired, prevent dissemination\nRequired, prevent dissemination\n3\nControl of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system\nOptional\nRequired, minimise dissemination\nRequired, prevent dissemination\nRequired, prevent dissemination\n4\nInactivation of bulk culture fluids before removal from the closed system\nOptional\nRequired, by validated means\nRequired, by validated means\nRequired, by validated means\n5\nSeals should be designed so as to minimise or prevent release\nNo specific requirement\nMinimise dissemination\nPrevent dissemination\nPrevent dissemination\n6\nThe controlled area should be designed to contain spillage of the entire contents of the closed system\nOptional\nOptional\nRequired\nRequired\n7\nThe controlled area should be sealable to permit fumigation\nNot required\nOptional\nOptional\nRequired\nEquipment\n8\nEntry via airlock\nNot required\nNot required\nOptional\nRequired\n9\nSurfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents, and easy to clean\nRequired (bench if any)\nRequired (bench if any)\nRequired (bench if any, floor)\nRequired (bench, floor, ceiling, walls)\n10\nSpecific measures to adequately ventilate the controlled area in order to minimise air contamination\nOptional\nOptional\nOptional\nRequired\n11\nThe controlled area should be maintained at an air pressure negative to the immediate surroundings\nNot required\nNot required\nOptional\nRequired\n12\nExtract and input air from the controlled area should be HEPA filtered\nNot required\nNot required\nRequired (extract air, optional for input air)\nRequired (input and extract air)\nSystem of work\n13\nClosed systems should be located within a controlled area\nNot required\nOptional\nRequired\nRequired\n14\nAccess should be restricted to nominated personnel only\nNot required\nRequired\nRequired\nRequired\n15\nBiohazard signs should be posted\nNot required\nRequired\nRequired\nRequired\n17\nPersonnel should shower before leaving the controlled area\nNot required\nNot required\nOptional\nRequired\n18\nPersonnel should wear protective clothing\nRequired (work clothing)\nRequired (work clothing)\nRequired\nComplete change before exit and entry\nWaste\n22\nInactivation of GMMs in effluent from hand-washing sinks and showers or similar effluents\nNot required\nNot required\nOptional\nRequired\n23\nInactivation of GMMs in contaminated material and waste, including those in process effluent before final discharge\nOptional\nRequired, by validated means\nRequired, by validated means\nRequired, by validated means",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Isolation the laboratory is separated from other areas in the same building or is in a separate building."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Airlock entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Activities where transmission does not occur via airborne route."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "HEPA High efficiency particulate air."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "Where viruses which are not retained by HEPA filters are used, extra requirements will be necessary for extract air."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "With validated procedures, allowing the safe transfer of material into an autoclave outside the lab, and providing an equivalent level of protection."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "The glasshouse shall consist of a permanent structure with a continuous waterproof covering, located on a site graded to prevent entry of surface-water run-off, and with self-closing lockable doors."
    },
    {
      "type": "footnote",
      "label": "f8",
      "text": "Where transmission can occur through the ground."
    },
    {
      "type": "footnote",
      "label": "f9",
      "text": "Animal unit a building or separate area within a building containing facilities and other areas such as changing rooms, showers, autoclaves, food storage areas, etc."
    },
    {
      "type": "footnote",
      "label": "f10",
      "text": "Animal facility a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures."
    },
    {
      "type": "footnote",
      "label": "f11",
      "text": "Isolators transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2009/41/annex/IV/division/CONTAINMENT",
    "retrieved_at": "2026-11-01T15:22:13.429635+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."
}