{
  "url": "https://openlegislation.uk/eu-directive-2000-54/annex-VI/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2000-54/annex-VI/division-1.json",
  "legislation": "eudr/2000/54",
  "legislation_title": "Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2000-54",
  "path": "annex/VI/division/1",
  "kind": "division",
  "number": null,
  "heading": "Preliminary note",
  "text": "In the table, ‘ Recommended ’ means that the measures should in principle be applied, unless the results of the assessment referred to in Article 3(2) indicate otherwise.\nGroup 1 biological agents\nFor work with group 1 biological agents including live attenuated vaccines, the principles of good occupational safety and hygiene should be observed.\nGroups 2, 3 and 4 biological agents\nIt may be appropriate to select and combine containment requirements from different categories below on the basis of a risk assessment related to any particular process or part of a process.\nHEPA: High efficiency particulate air\nClosed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.).\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.\nA. Containment measures\nB. Containment levels\n2\n3\n4\nGeneral\n1. Viable organisms should be handled in a system which physically separates the process from the environment\nYes\nYes\nYes\n2. Exhaust gases from the closed system should be treated so as to:\nMinimise release\nPrevent release\nPrevent release\n3. Sample collection, addition of materials to a closed system and transfer of viable organisms to another closed system, should be performed so as to:\nMinimise release\nPrevent release\nPrevent release\n4. Bulk culture fluids should not be removed from the closed system unless the viable organisms have been:\nInactivated by validated chemical or physical means\nInactivated by validated chemical or physical means\nInactivated by validated chemical or physical means\n5. Seals should be designed so as to:\nMinimise release\nPrevent release\nPrevent release\n6. The controlled area should be designed to contain spillage of the entire contents of the closed system\nNo\nRecommended\nYes\n7. The controlled area should be sealable to permit fumigation\nNo\nRecommended\nYes\nFacilities\n8. Decontamination and washing facilities should be provided for personnel\nYes\nYes\nYes\nEquipment\n9. Input air and extract air to the controlled area should be HEPA filtered\nNo\nRecommended\nYes\n10. The controlled area should be maintained at an air pressure negative to atmosphere\nNo\nRecommended\nYes\n11. The controlled area should be adequately ventilated to minimise air contamination\nRecommended\nRecommended\nYes\nSystem of work\n12. Closed systems should be located within a controlled area\nRecommended\nRecommended\nYes, and purpose-built\n13. Biohazard signs should be posted\nRecommended\nYes\nYes\n14. Access should be restricted to nominated personnel only\nRecommended\nYes\nYes, via an airlock\n15. Personnel should shower before leaving the controlled area\nNo\nRecommended\nYes\n16. Personnel should wear protective clothing\nYes, work clothing\nYes\nYes, complete change\nWaste\n17. Effluent from sinks and showers should be collected and inactivated before release\nNo\nRecommended\nYes\n18. Effluent treatment before final discharge\nInactivated by validated chemical or physical means\nInactivated by validated chemical or physical means\nInactivated by validated chemical or physical means",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Directive (EU) 2019/1833 of 24 October 2019 amending Annexes I, III, V and VI to Directive 2000/54/EC of the European Parliament and of the Council as regards purely technical adjustments."
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "HEPA: High efficiency particulate air"
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Closed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.)."
    },
    {
      "type": "footnote",
      "label": "f3",
      "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."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2000/54/annex/VI/division/1",
    "retrieved_at": "2026-11-01T15:23:02.086169+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."
}