{
  "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-4/division-1",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-4/division-1.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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)",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/B/division/4/division/1",
  "kind": "division",
  "number": null,
  "heading": "Introduction",
  "text": "The provisions of this Section only cover analytical methods required for post-registration control and monitoring purposes.\nPost-approval monitoring might be considered for all areas of risk assessment. This is particularly the case when (strains of) micro-organisms that are non-indigenous to the intended area of application are considered for approval. For analytical methods used for generation of data as required in this Regulation or for other purposes the applicant has to provide a justification for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes.\nDescriptions of methods must be provided and include details of equipment, materials and conditions used. The applicability of any internationally recognised method must be reported.\nAs far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment.\nData on specificity, linearity, accuracy and repeatability, as defined in points 4.1 and 4.2 of Part A of this Annex, are also required for methods used to analyse micro-organisms and their residues.\nFor this Section the following applies:\nImpurities, Metabolites, Relevant metabolites, Residues\nAs defined in Regulation (EC) No 1107/2009\nRelevant impurities\nImpurities, as defined above, that are of concern for human or animal health and/or the environment\nOn request the following samples must be provided:\n(i)samples of the micro-organism as manufactured;\n(ii)analytical standards of relevant metabolites (especially toxins) and all other components included in the residue definition;\n(iii)if available, samples of reference substances for the relevant impurities.",
  "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/B/division/4/division/1",
    "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."
}