{
  "url": "https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-4/division-4.1",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-4/division-4.1.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/4/division/4.1",
  "kind": "division",
  "number": "4.1",
  "heading": "In vitro studies",
  "text": "For all technological and some sensory additives affecting the characteristics of feed, efficacy shall be demonstrated using a laboratory-based study. The study shall be designed to cover a representative range of materials to which the additive will be applied. Results shall be evaluated preferably by parameter-free tests, and shall demonstrate expected changes with a probability of P ≤ 0,05.\nIn vitro studies, particularly those which simulate aspects of the gastrointestinal tract, may be used for other types of additives in order to support the efficacy. These studies should be capable of statistical evaluation.",
  "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/4/division/4.1",
    "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."
}