{
  "url": "https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.2/division-3.2.2/division-3.2.2.5/division-3.2.2.5.1",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.2/division-3.2.2/division-3.2.2.5/division-3.2.2.5.1.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/3.2/division/3.2.2/division/3.2.2.5/division/3.2.2.5.1",
  "kind": "division",
  "number": "3.2.2.5.1",
  "heading": "Two generation reproduction toxicity study",
  "text": "Studies of reproductive function must be carried out and extend over at least two filial generations (F1, F2) in at least one species, usually a rodent, and may be combined with a teratogenicity study. The substance under investigation shall be administered orally to males and females at an appropriate time prior to mating. Administration shall continue until the weaning of the F2 generation.\nAll relevant fertility, gestation, parturition, maternal behaviour, suckling, growth and development of the F1 offspring from fertilisation to maturity and the development of the F2 offspring to weaning must be carefully observed and reported. Protocols for the reproduction toxicity study should be in line with OECD Guideline 416.",
  "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/3.2/division/3.2.2/division/3.2.2.5/division/3.2.2.5.1",
    "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."
}