{
  "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.6",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.6.json",
  "legislation": "eur/2011/544",
  "legislation_title": "Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2011-544",
  "path": "annex/part/A/division/5/division/5.6",
  "kind": "division",
  "number": "5.6",
  "heading": "Reproductive toxicity",
  "text": "The adverse reproductive effects are of two main types:\nimpairment of male or female fertility, and\nimpacts on the normal development of progeny (developmental toxicity).\nPossible effects on all aspects of reproductive physiology in both males and females, as well as possible effects on pre-natal and post-natal development, must be investigated and reported. If in exceptional circumstances, it is claimed that such testing is unnecessary, that claim must be fully justified.\nWhile the standard reference point for treatment responses are concurrent control data, historical control data may be helpful in the interpretation of particular reproductive studies. Where submitted, historical control data shall be from the same species and strain, maintained under similar conditions and shall be from contemporaneous studies. The information on historical control data provided must include:\nidentification of species and strain, name of the supplier, and specific colony identification, if the supplier has more than one geographical location,\nname of the laboratory and the dates when the study was performed,\ndescription of the general conditions under which animals were maintained, including the type or brand of diet and, where possible, the amount consumed,\napproximate age, in days, of the control animals at the beginning of the study and at the time of killing or death,\ndescription of the control group mortality pattern observed during or at the end of the study, and other pertinent observations (e.g. diseases, infections), and\nname of the laboratory and the examining scientist responsible for gathering and interpreting the toxicological data from the study.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Repealed (subject to transitional measures in Arts. 3, 4) by Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Text with EEA relevance."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/5/division/5.6",
    "retrieved_at": "2026-11-01T14:50:06.051752+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."
}