{
  "url": "https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-4/division-4.1/division-4.1.3/division-4.1.3.2",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-4/division-4.1/division-4.1.3/division-4.1.3.2.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/III/division/4/division/4.1/division/4.1.3/division/4.1.3.2",
  "kind": "division",
  "number": "4.1.3.2",
  "heading": "Studies concerning the safety of use of the additive for consumer",
  "text": "(1)Metabolic and residue studies\nThese studies are not required if:\nthe substance or its metabolites can be demonstrated to be excreted unchanged and essentially to be not absorbed; or\nthe substance is absorbed in physiological form and physiological level of compound(s).\nNo metabolic studies are needed if the substance is naturally present in significant amounts in food or feedingstuffs or if the substance is a normal constituent of body fluids or tissues. However, in these cases, there is a requirement for residue studies which can be limited to a comparison of the levels in the tissues or products in an untreated group to the levels found in the group supplemented with the highest recommended dose.\nIn all other cases the whole of subsection 3.2.1 of Annex II applies.\n(2)Toxicological studies\nToxicological studies are not required if the substance is absorbed in the form of physiological compound(s).\nFor xenobiotic substances the whole of subsection 3.2.2 of Annex II applies.\nFor other substances, a case by case approach shall be used, taking into account the level and means of exposure, and any omission of data prescribed in this section must be fully justified.\n(3)Assessment of consumer safety\nThe whole of subsection 3.2.3 of Annex II applies for food producing animals.",
  "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/III/division/4/division/4.1/division/4.1.3/division/4.1.3.2",
    "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."
}