{
  "url": "https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.3/division-3.3.1/division-3.3.1.1",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.3/division-3.3.1/division-3.3.1.1.json",
  "legislation": "eur/2008/429",
  "legislation_title": "Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2008-429",
  "path": "annex/II/division/3/division/3.3/division/3.3.1/division/3.3.1.1",
  "kind": "division",
  "number": "3.3.1.1",
  "heading": "Effects on the respiratory system",
  "text": "Evidence shall be provided that airborne levels of dust or mist of the additive will not constitute a hazard to the health of users/workers. This evidence shall include, where necessary:\ninhalation tests in laboratory animals;\npublished epidemiological data and/or the applicants own data on its work plant and/or irritancy; and\nrespiratory system sensitisation tests.\nAcute inhalation toxicity studies shall be performed if particles or droplets with a diameter of less than 50 μm constitute more than 1 % on a weight basis of the product.\nProtocols for acute inhalation toxicity studies should be in line with OECD Guideline 403. If sub-chronic toxicity studies are considered necessary, they should follow OECD Guidelines 412 (Repeated Dose Inhalation Toxicity: 28-day or 14-day study) or 413 (Sub-chronic Inhalation Toxicity: 90-day study).",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2008/429/annex/II/division/3/division/3.3/division/3.3.1/division/3.3.1.1",
    "retrieved_at": "2026-11-01T14:52:17.021143+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."
}