{
  "url": "https://openlegislation.uk/eu-regulation-2011-544",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-544.json",
  "id": "eur/2011/544",
  "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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)",
  "short_title": "Regulation (EU) No 544/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the…",
  "long_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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)",
  "citation": "EU Regulation No 544/2011",
  "type": "eur",
  "year": "2011",
  "number": "544",
  "version": "current",
  "date": "2011-06-10",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 4,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/A1",
      "kind": "article",
      "number": "A1",
      "heading": "Scope and interpretation",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/article-A1",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/article-2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex",
      "kind": "annex",
      "number": null,
      "heading": "DATA REQUIREMENTS FOR ACTIVE SUBSTANCES, AS PROVIDED FOR IN ARTICLE 8(1)(b) OF REGULATION (EC) No 1107/2009",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/division/1",
      "kind": "division",
      "number": null,
      "heading": "INTRODUCTION",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex"
    },
    {
      "path": "annex/division/1/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/division-1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/1"
    },
    {
      "path": "annex/division/1/division/2",
      "kind": "division",
      "number": "2",
      "heading": "Test and analyses",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/1"
    },
    {
      "path": "annex/division/1/division/2/division/2.1",
      "kind": "division",
      "number": "2.1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/division-1/division-2/division-2.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/1/division/2"
    },
    {
      "path": "annex/division/1/division/2/division/2.2",
      "kind": "division",
      "number": "2.2",
      "heading": "By way of derogation from point 2.1, the competent authority may provide that tests and analyses, performed on their constituent territory in order to obtain data on the properties and/or safety of the active substances with respect to honey-bees and beneficial arthropods other than bees shall be conducted by official or officially-recognised testing facilities or organisations which satisfy at least the requirements as set out under points 2.2 and 2.3 of the introduction to the Annex to Commission Regulation (EU) No 545/2011.",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/division-1/division-2/division-2.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/1/division/2"
    },
    {
      "path": "annex/division/1/division/2/division/2.3",
      "kind": "division",
      "number": "2.3",
      "heading": "By way of derogation from point 2.1, the competent authority may provide that supervised residue trials performed on their constituent territory in accordance with Section 6 ‘Residues in or on treated products, food and feed’ on plant protection products containing active substances already on the market on or before 25th July 1993 shall be conducted by official or officially-recognised testing facilities or organisations which satisfy at least the requirements under points 2.2 and 2.3 of the introduction to the Annex to Regulation (EU) No 545/2011.",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/division-1/division-2/division-2.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/1/division/2"
    },
    {
      "path": "annex/division/1/division/2/division/2.4",
      "kind": "division",
      "number": "2.4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/division-1/division-2/division-2.4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/1/division/2"
    },
    {
      "path": "annex/part/A",
      "kind": "part",
      "number": "A",
      "heading": "CHEMICAL SUBSTANCES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex"
    },
    {
      "path": "annex/part/A/division/1",
      "kind": "division",
      "number": "1",
      "heading": "Identity of the active substance",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A"
    },
    {
      "path": "annex/part/A/division/1/division/1.1",
      "kind": "division",
      "number": "1.1",
      "heading": "Applicant (name, address, etc.)",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/1/division/1.2",
      "kind": "division",
      "number": "1.2",
      "heading": "Manufacturer (name, address, including location of plant)",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/1/division/1.3",
      "kind": "division",
      "number": "1.3",
      "heading": "Common name proposed or ISO-accepted, and synonyms",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/1/division/1.4",
      "kind": "division",
      "number": "1.4",
      "heading": "Chemical name (IUPAC and CA nomenclature)",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/1/division/1.4.1",
      "kind": "division",
      "number": "1.4.1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.4.1",
      "extent": null,
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/1/division/1.5",
      "kind": "division",
      "number": "1.5",
      "heading": "Manufacturer’s development code number(s)",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/1/division/1.6",
      "kind": "division",
      "number": "1.6",
      "heading": "CAS, EC and CIPAC numbers (if available)",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/1/division/1.7",
      "kind": "division",
      "number": "1.7",
      "heading": "Molecular and structural formula, molecular mass",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/1/division/1.8",
      "kind": "division",
      "number": "1.8",
      "heading": "Method of manufacture (synthesis pathway) of the active substance",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/1/division/1.9",
      "kind": "division",
      "number": "1.9",
      "heading": "Specification of purity of the active substance in g/kg",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/1/division/1.10",
      "kind": "division",
      "number": "1.10",
      "heading": "Identity of isomers, impurities and additives (e.g. stabilisers), together with the structural formula and the content expressed as g/kg",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/1/division/1.11",
      "kind": "division",
      "number": "1.11",
      "heading": "Analytical profile of batches",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/1"
    },
    {
      "path": "annex/part/A/division/2",
      "kind": "division",
      "number": "2",
      "heading": "Physical and chemical properties of the active substance",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A"
    },
    {
      "path": "annex/part/A/division/2/division/i",
      "kind": "division",
      "number": "(i)",
      "heading": "The information provided, must describe the physical and chemical properties of active substances and together with relevant information, must serve to characterise them. In particular, the information provided must permit:",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-i",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/ii",
      "kind": "division",
      "number": "(ii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-ii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/iii",
      "kind": "division",
      "number": "(iii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-iii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/iv",
      "kind": "division",
      "number": "(iv)",
      "heading": "In certain specified instances, tests must be conducted using purified active substance of stated specification. In such cases the principles of the method(s) of purification must be reported. The purity of such test material, which must be as high as can be achieved using the best available technology, must be reported. A reasoned justification must be provided in cases where the degree of purity achieved is less than 980 g/kg.",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-iv",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/2.1",
      "kind": "division",
      "number": "2.1",
      "heading": "Melting point and boiling point",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/2.1/division/2.1.1",
      "kind": "division",
      "number": "2.1.1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.1/division-2.1.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2/division/2.1"
    },
    {
      "path": "annex/part/A/division/2/division/2.1/division/2.1.2",
      "kind": "division",
      "number": "2.1.2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.1/division-2.1.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2/division/2.1"
    },
    {
      "path": "annex/part/A/division/2/division/2.1/division/2.1.3",
      "kind": "division",
      "number": "2.1.3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.1/division-2.1.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2/division/2.1"
    },
    {
      "path": "annex/part/A/division/2/division/2.2",
      "kind": "division",
      "number": "2.2",
      "heading": "Relative density",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/2.3",
      "kind": "division",
      "number": "2.3",
      "heading": "Vapour pressure (in Pa), volatility (e.g. Henry’s law constant)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/2.3/division/2.3.1",
      "kind": "division",
      "number": "2.3.1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.3/division-2.3.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2/division/2.3"
    },
    {
      "path": "annex/part/A/division/2/division/2.3/division/2.3.2",
      "kind": "division",
      "number": "2.3.2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.3/division-2.3.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2/division/2.3"
    },
    {
      "path": "annex/part/A/division/2/division/2.4",
      "kind": "division",
      "number": "2.4",
      "heading": "Appearance (physical state, colour and odour; if known)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/2.4/division/2.4.1",
      "kind": "division",
      "number": "2.4.1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.4/division-2.4.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2/division/2.4"
    },
    {
      "path": "annex/part/A/division/2/division/2.4/division/2.4.2",
      "kind": "division",
      "number": "2.4.2",
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      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.4/division-2.4.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2/division/2.4"
    },
    {
      "path": "annex/part/A/division/2/division/2.5",
      "kind": "division",
      "number": "2.5",
      "heading": "Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
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    {
      "path": "annex/part/A/division/2/division/2.5/division/2.5.1",
      "kind": "division",
      "number": "2.5.1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.5/division-2.5.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2/division/2.5"
    },
    {
      "path": "annex/part/A/division/2/division/2.5/division/2.5.2",
      "kind": "division",
      "number": "2.5.2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.5/division-2.5.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2/division/2.5"
    },
    {
      "path": "annex/part/A/division/2/division/2.6",
      "kind": "division",
      "number": "2.6",
      "heading": "Solubility in water including effect of pH (4 to 10) on solubility",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/2.7",
      "kind": "division",
      "number": "2.7",
      "heading": "Solubility in organic solvents",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/2.8",
      "kind": "division",
      "number": "2.8",
      "heading": "Partition coefficient n-octanol/water including effect of pH (4 to 10)",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/2.9",
      "kind": "division",
      "number": "2.9",
      "heading": "Stability in water, hydrolysis rate, photochemical degradation, quantum yield and identity of breakdown product(s), dissociation constant including effect of pH (4 to 9)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2"
    },
    {
      "path": "annex/part/A/division/2/division/2.9/division/2.9.1",
      "kind": "division",
      "number": "2.9.1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.9/division-2.9.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2/division/2.9"
    },
    {
      "path": "annex/part/A/division/2/division/2.9/division/2.9.2",
      "kind": "division",
      "number": "2.9.2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.9/division-2.9.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/2/division/2.9"
    },
    {
      "path": "annex/part/A/division/2/division/2.9/division/2.9.3",
      "kind": "division",
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      "path": "annex/part/A/division/6/division/6.4/division/1",
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      "path": "annex/part/A/division/6/division/6.4/division/2",
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      "path": "annex/part/A/division/6/division/6.5/division/1",
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      "path": "annex/part/A/division/6/division/6.5/division/6.5.1/division/1",
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      "heading": "Residues in succeeding crops",
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      "path": "annex/part/A/division/6/division/6.6/division/1",
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      "heading": "Aim of the test",
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      "path": "annex/part/A/division/6/division/6.6/division/2",
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      "path": "annex/part/A/division/6/division/6.8",
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      "path": "annex/part/A/division/6/division/6.9",
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      "path": "annex/part/A/division/7/division/1",
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      "heading": "In particular, the information provided for the active substance, together with other relevant information, and that provided for one or more preparations containing it shall be sufficient to:",
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      "kind": "division",
      "number": "(iii)",
      "heading": "A detailed description (specification) of the material used, as provided for under point 1.11 must be provided. Where testing is done using active substance the material used shall be of that specification that will be used in the manufacture of preparations to be authorised except where radio-labelled material is used.",
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      "path": "annex/part/A/division/7/division/7.1/division/7.1.1/division/7.1.1.1/division/7.1.1.1.1/division/3",
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      "heading": "Test guideline",
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      "number": "(ii)",
      "heading": "In particular, the information provided for the active substance, together with other relevant information, and that provided for one or more preparations containing it, shall be sufficient to:",
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    {
      "path": "annex/part/A/division/8/division/1/division/iii",
      "kind": "division",
      "number": "(iii)",
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      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-8/division-1/division-iii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/8/division/1"
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      "path": "annex/part/A/division/8/division/1/division/iv",
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      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-8/division-1/division-iv",
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    {
      "path": "annex/part/A/division/8/division/2",
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      "heading": "Test substance",
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      "extent": "E+W+S+N.I.",
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      "path": "annex/part/A/division/8/division/2/division/vi",
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      "extent": "E+W+S+N.I.",
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      "path": "annex/part/A/division/8/division/8.1/division/8.1.1",
      "kind": "division",
      "number": "8.1.1",
      "heading": "Acute oral toxicity",
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      "extent": "E+W+S+N.I.",
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    },
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      "path": "annex/part/A/division/8/division/8.1/division/8.1.1/division/1",
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      "parent": "annex/part/A/division/8/division/8.1/division/8.1.1"
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      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-8/division-8.1/division-8.1.1/division-2",
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      "path": "annex/part/A/division/8/division/8.1/division/8.1.1/division/3",
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      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-8/division-8.1/division-8.1.1/division-3",
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      "parent": "annex/part/A/division/8/division/8.1/division/8.1.1"
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      "path": "annex/part/A/division/8/division/8.1/division/8.1.1/division/4",
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      "heading": "Test guideline",
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      "heading": "Short-term dietary toxicity",
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      "path": "annex/part/A/division/8/division/8.1/division/8.1.2/division/2",
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      "heading": "Subchronic toxicity and reproduction",
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      "heading": "Acute toxicity to fish",
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      "path": "annex/part/A/division/8/division/8.2/division/8.2.1/division/2",
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      "path": "annex/part/A/division/8/division/8.6",
      "kind": "division",
      "number": "8.6",
      "heading": "Effects on other non-target organisms (flora and fauna) believed to be at risk",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-8/division-8.6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/8"
    },
    {
      "path": "annex/part/A/division/8/division/8.7",
      "kind": "division",
      "number": "8.7",
      "heading": "Effects on biological methods for sewage treatment",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-8/division-8.7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A/division/8"
    },
    {
      "path": "annex/part/A/division/9",
      "kind": "division",
      "number": "9",
      "heading": "Summary and evaluation of Sections 7 and 8",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A"
    },
    {
      "path": "annex/part/A/division/10",
      "kind": "division",
      "number": "10",
      "heading": "Proposals including justification for the proposals for the classification and labelling of the active substance in accordance with Regulation (EC) No 1272/2008",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A"
    },
    {
      "path": "annex/part/A/division/11",
      "kind": "division",
      "number": "11",
      "heading": "A dossier as referred to in Part A of the Annex to Regulation (EU) No 545/2011, for a representative plant protection product",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A"
    },
    {
      "path": "annex/part/B",
      "kind": "part",
      "number": "B",
      "heading": "MICRO-ORGANISMS INCLUDING VIRUSES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex"
    },
    {
      "path": "annex/part/B/division/n1",
      "kind": "division",
      "number": null,
      "heading": "Introduction",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B"
    },
    {
      "path": "annex/part/B/division/n1/division/i",
      "kind": "division",
      "number": "(i)",
      "heading": "Active substances are defined in Article 2(2) of Regulation (EC) No 1107/2009 and include chemical substances and micro-organisms including viruses.",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-n1/division-i",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/n1"
    },
    {
      "path": "annex/part/B/division/n1/division/ii",
      "kind": "division",
      "number": "(ii)",
      "heading": "For all micro-organisms that are subject to application all available relevant knowledge and information in literature should be provided.",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-n1/division-ii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/n1"
    },
    {
      "path": "annex/part/B/division/n1/division/iii",
      "kind": "division",
      "number": "(iii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-n1/division-iii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/n1"
    },
    {
      "path": "annex/part/B/division/n1/division/iv",
      "kind": "division",
      "number": "(iv)",
      "heading": "Where testing is done, a detailed description (specification) of the material used and its impurities, in accordance with point 1.4, must be provided. The material used shall be of that specification that will be used in the manufacture of preparations to be authorised.",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-n1/division-iv",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/n1"
    },
    {
      "path": "annex/part/B/division/n1/division/v",
      "kind": "division",
      "number": "(v)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-n1/division-v",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/n1"
    },
    {
      "path": "annex/part/B/division/n1/division/vi",
      "kind": "division",
      "number": "(vi)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-n1/division-vi",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/n1"
    },
    {
      "path": "annex/part/B/division/n1/division/vii",
      "kind": "division",
      "number": "(vii)",
      "heading": "In the case of studies in which dosing extends over a period, dosing shall preferably be done using a single batch of the micro-organism, if stability permits.",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-n1/division-vii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/n1"
    },
    {
      "path": "annex/part/B/division/n1/division/viii",
      "kind": "division",
      "number": "(viii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-n1/division-viii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/n1"
    },
    {
      "path": "annex/part/B/division/1",
      "kind": "division",
      "number": "1",
      "heading": "Identity of the micro-organism",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B"
    },
    {
      "path": "annex/part/B/division/1/division/1.1",
      "kind": "division",
      "number": "1.1",
      "heading": "Applicant",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1"
    },
    {
      "path": "annex/part/B/division/1/division/1.2",
      "kind": "division",
      "number": "1.2",
      "heading": "Producer",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1"
    },
    {
      "path": "annex/part/B/division/1/division/1.3",
      "kind": "division",
      "number": "1.3",
      "heading": "Name and species description, strain characterisation",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1"
    },
    {
      "path": "annex/part/B/division/1/division/1.3/division/i",
      "kind": "division",
      "number": "(i)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.3/division-i",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1/division/1.3"
    },
    {
      "path": "annex/part/B/division/1/division/1.3/division/ii",
      "kind": "division",
      "number": "(ii)",
      "heading": "Each micro-organism that is subject to the application shall be identified and named at the species level. The scientific name and taxonomic grouping, i.e. family, genus, species, strain, serotype, pathovar or any other denomination relevant to the micro-organism, must be stated.",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.3/division-ii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1/division/1.3"
    },
    {
      "path": "annex/part/B/division/1/division/1.3/division/iii",
      "kind": "division",
      "number": "(iii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.3/division-iii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1/division/1.3"
    },
    {
      "path": "annex/part/B/division/1/division/1.3/division/iv",
      "kind": "division",
      "number": "(iv)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.3/division-iv",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1/division/1.3"
    },
    {
      "path": "annex/part/B/division/1/division/1.3/division/v",
      "kind": "division",
      "number": "(v)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.3/division-v",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1/division/1.3"
    },
    {
      "path": "annex/part/B/division/1/division/1.4",
      "kind": "division",
      "number": "1.4",
      "heading": "Specification of the material used for manufacturing of formulated products",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1"
    },
    {
      "path": "annex/part/B/division/1/division/1.4/division/1.4.1",
      "kind": "division",
      "number": "1.4.1",
      "heading": "Content of the micro-organism",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.4/division-1.4.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1/division/1.4"
    },
    {
      "path": "annex/part/B/division/1/division/1.4/division/1.4.2",
      "kind": "division",
      "number": "1.4.2",
      "heading": "Identity and content of impurities, additives, contaminating micro-organisms",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.4/division-1.4.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1/division/1.4"
    },
    {
      "path": "annex/part/B/division/1/division/1.4/division/1.4.3",
      "kind": "division",
      "number": "1.4.3",
      "heading": "Analytical profile of batches",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.4/division-1.4.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/1/division/1.4"
    },
    {
      "path": "annex/part/B/division/2",
      "kind": "division",
      "number": "2",
      "heading": "Biological properties of the micro-organism",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B"
    },
    {
      "path": "annex/part/B/division/2/division/2.1",
      "kind": "division",
      "number": "2.1",
      "heading": "History of the micro-organism and its uses. Natural occurrence and geographical distribution",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2"
    },
    {
      "path": "annex/part/B/division/2/division/2.1/division/2.1.1",
      "kind": "division",
      "number": "2.1.1",
      "heading": "Historical background",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.1/division-2.1.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2/division/2.1"
    },
    {
      "path": "annex/part/B/division/2/division/2.1/division/2.1.2",
      "kind": "division",
      "number": "2.1.2",
      "heading": "Origin and natural occurrence",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.1/division-2.1.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2/division/2.1"
    },
    {
      "path": "annex/part/B/division/2/division/2.2",
      "kind": "division",
      "number": "2.2",
      "heading": "Information on target organism(s)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2"
    },
    {
      "path": "annex/part/B/division/2/division/2.2/division/2.2.1",
      "kind": "division",
      "number": "2.2.1",
      "heading": "Description of the target organism(s)",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.2/division-2.2.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2/division/2.2"
    },
    {
      "path": "annex/part/B/division/2/division/2.2/division/2.2.2",
      "kind": "division",
      "number": "2.2.2",
      "heading": "Mode of action",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.2/division-2.2.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2/division/2.2"
    },
    {
      "path": "annex/part/B/division/2/division/2.3",
      "kind": "division",
      "number": "2.3",
      "heading": "Host specificity range and effects on species other than the target harmful organism",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2"
    },
    {
      "path": "annex/part/B/division/2/division/2.4",
      "kind": "division",
      "number": "2.4",
      "heading": "Development stages/life cycle of the micro-organism",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2"
    },
    {
      "path": "annex/part/B/division/2/division/2.5",
      "kind": "division",
      "number": "2.5",
      "heading": "Infectiveness, dispersal and colonisation ability",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2"
    },
    {
      "path": "annex/part/B/division/2/division/2.6",
      "kind": "division",
      "number": "2.6",
      "heading": "Relationships to known plant or animal or human pathogens",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2"
    },
    {
      "path": "annex/part/B/division/2/division/2.7",
      "kind": "division",
      "number": "2.7",
      "heading": "Genetic stability and factors affecting it",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2"
    },
    {
      "path": "annex/part/B/division/2/division/2.8",
      "kind": "division",
      "number": "2.8",
      "heading": "Information on the production of metabolites (especially toxins)",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2"
    },
    {
      "path": "annex/part/B/division/2/division/2.9",
      "kind": "division",
      "number": "2.9",
      "heading": "Antibiotics and other anti-microbial agents",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-2/division-2.9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2"
    },
    {
      "path": "annex/part/B/division/3",
      "kind": "division",
      "number": "3",
      "heading": "Further information on the micro-organism",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B"
    },
    {
      "path": "annex/part/B/division/3/division/1",
      "kind": "division",
      "number": null,
      "heading": "Introduction",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/3"
    },
    {
      "path": "annex/part/B/division/3/division/1/division/i",
      "kind": "division",
      "number": "(i)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-3/division-1/division-i",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/3/division/1"
    },
    {
      "path": "annex/part/B/division/3/division/1/division/ii",
      "kind": "division",
      "number": "(ii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-3/division-1/division-ii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/3/division/1"
    },
    {
      "path": "annex/part/B/division/3/division/1/division/iii",
      "kind": "division",
      "number": "(iii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-3/division-1/division-iii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/3/division/1"
    },
    {
      "path": "annex/part/B/division/3/division/1/division/iv",
      "kind": "division",
      "number": "(iv)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-3/division-1/division-iv",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/3/division/1"
    },
    {
      "path": "annex/part/B/division/3/division/3.1",
      "kind": "division",
      "number": "3.1",
      "heading": "Function",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-3/division-3.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/3"
    },
    {
      "path": "annex/part/B/division/3/division/3.2",
      "kind": "division",
      "number": "3.2",
      "heading": "Field of use envisaged",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-3/division-3.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/3"
    },
    {
      "path": "annex/part/B/division/3/division/3.3",
      "kind": "division",
      "number": "3.3",
      "heading": "Crops or products protected or treated",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-3/division-3.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/3"
    },
    {
      "path": "annex/part/B/division/3/division/3.4",
      "kind": "division",
      "number": "3.4",
      "heading": "Method of production and quality control",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-3/division-3.4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/3"
    },
    {
      "path": "annex/part/B/division/3/division/3.5",
      "kind": "division",
      "number": "3.5",
      "heading": "Information on the occurrence or possible occurrence of the development of resistance of the target organism(s)",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-3/division-3.5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/3"
    },
    {
      "path": "annex/part/B/division/3/division/3.6",
      "kind": "division",
      "number": "3.6",
      "heading": "Methods to prevent loss of virulence of seed stock of the micro-organism",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-3/division-3.6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/3"
    },
    {
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      "path": "annex/part/B/division/5/division/3/division/5.4/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-5/division-3/division-5.4/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5/division/3/division/5.4"
    },
    {
      "path": "annex/part/B/division/5/division/3/division/5.5",
      "kind": "division",
      "number": "5.5",
      "heading": "Genotoxicity — In vivo studies in germ cells",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5/division/3"
    },
    {
      "path": "annex/part/B/division/5/division/3/division/5.5/division/1",
      "kind": "division",
      "number": null,
      "heading": "Aim of the test and test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-5/division-3/division-5.5/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5/division/3/division/5.5"
    },
    {
      "path": "annex/part/B/division/5/division/3/division/5.5/division/2",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-5/division-3/division-5.5/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5/division/3/division/5.5"
    },
    {
      "path": "annex/part/B/division/5/division/5.6",
      "kind": "division",
      "number": "5.6",
      "heading": "Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-5/division-5.6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5"
    },
    {
      "path": "annex/part/B/division/6",
      "kind": "division",
      "number": "6",
      "heading": "Residues in or on treated products, food and feed",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B"
    },
    {
      "path": "annex/part/B/division/6/division/1",
      "kind": "division",
      "number": null,
      "heading": "Introduction",
      "url": null,
      "extent": "E+W+S+N.I.",
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      "parent": "annex/part/B/division/6"
    },
    {
      "path": "annex/part/B/division/6/division/1/division/i",
      "kind": "division",
      "number": "(i)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-6/division-1/division-i",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/6/division/1"
    },
    {
      "path": "annex/part/B/division/6/division/1/division/ii",
      "kind": "division",
      "number": "(ii)",
      "heading": "In addition, the information provided must be sufficient to:",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-6/division-1/division-ii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/6/division/1"
    },
    {
      "path": "annex/part/B/division/6/division/1/division/iii",
      "kind": "division",
      "number": "(iii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-6/division-1/division-iii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/6/division/1"
    },
    {
      "path": "annex/part/B/division/6/division/6.1",
      "kind": "division",
      "number": "6.1",
      "heading": "Persistence and likelihood of multiplication in or on crops, feedingstuffs or foodstuffs",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-6/division-6.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/6"
    },
    {
      "path": "annex/part/B/division/6/division/6.2",
      "kind": "division",
      "number": "6.2",
      "heading": "Further information required",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-6/division-6.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/6"
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    {
      "path": "annex/part/B/division/6/division/6.2/division/6.2.1",
      "kind": "division",
      "number": "6.2.1",
      "heading": "Non-viable residues",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-6/division-6.2/division-6.2.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/6/division/6.2"
    },
    {
      "path": "annex/part/B/division/6/division/6.2/division/6.2.2",
      "kind": "division",
      "number": "6.2.2",
      "heading": "Viable residues",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-6/division-6.2/division-6.2.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/6/division/6.2"
    },
    {
      "path": "annex/part/B/division/6/division/6.3",
      "kind": "division",
      "number": "6.3",
      "heading": "Summary and evaluation of residue behaviour resulting from data submitted under points 6.1 and 6.2",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/6"
    },
    {
      "path": "annex/part/B/division/7",
      "kind": "division",
      "number": "7",
      "heading": "Fate and behaviour in the environment",
      "url": null,
      "extent": "E+W+S+N.I.",
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      "parent": "annex/part/B"
    },
    {
      "path": "annex/part/B/division/7/division/1",
      "kind": "division",
      "number": null,
      "heading": "Introduction",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7"
    },
    {
      "path": "annex/part/B/division/7/division/1/division/i",
      "kind": "division",
      "number": "(i)",
      "heading": "Information on the origin, the properties, and the survival of the micro-organism and its residual metabolites as well as its intended use form the basis for an assessment of environmental fate and behaviour.",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-7/division-1/division-i",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7/division/1"
    },
    {
      "path": "annex/part/B/division/7/division/1/division/ii",
      "kind": "division",
      "number": "(ii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-7/division-1/division-ii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7/division/1"
    },
    {
      "path": "annex/part/B/division/7/division/1/division/iii",
      "kind": "division",
      "number": "(iii)",
      "heading": "In particular, the information provided shall be sufficient to:",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-7/division-1/division-iii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7/division/1"
    },
    {
      "path": "annex/part/B/division/7/division/1/division/iv",
      "kind": "division",
      "number": "(iv)",
      "heading": "Any relevant metabolites (i.e. of concern for human health and/or the environment) formed by the test organism under any relevant environmental conditions shall be characterised. If relevant metabolites are present in or produced by the micro-organism, data as outlined under Section 7 of Part A of this Annex may be required, if all of the following conditions are met:",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-7/division-1/division-iv",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7/division/1"
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    {
      "path": "annex/part/B/division/7/division/1/division/v",
      "kind": "division",
      "number": "(v)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-7/division-1/division-v",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7/division/1"
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    {
      "path": "annex/part/B/division/7/division/1/division/vi",
      "kind": "division",
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      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-7/division-1/division-vi",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7/division/1"
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    {
      "path": "annex/part/B/division/7/division/7.1",
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      "number": "7.1",
      "heading": "Persistence and multiplication",
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      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7"
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    {
      "path": "annex/part/B/division/7/division/7.1/division/7.1.1",
      "kind": "division",
      "number": "7.1.1",
      "heading": "Soil",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-7/division-7.1/division-7.1.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7/division/7.1"
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    {
      "path": "annex/part/B/division/7/division/7.1/division/7.1.2",
      "kind": "division",
      "number": "7.1.2",
      "heading": "Water",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-7/division-7.1/division-7.1.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7/division/7.1"
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    {
      "path": "annex/part/B/division/7/division/7.1/division/7.1.3",
      "kind": "division",
      "number": "7.1.3",
      "heading": "Air",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-7/division-7.1/division-7.1.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7/division/7.1"
    },
    {
      "path": "annex/part/B/division/7/division/7.2",
      "kind": "division",
      "number": "7.2",
      "heading": "Mobility",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-7/division-7.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/7"
    },
    {
      "path": "annex/part/B/division/8",
      "kind": "division",
      "number": "8",
      "heading": "Effects on non-target organisms",
      "url": null,
      "extent": "E+W+S+N.I.",
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      "parent": "annex/part/B"
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    {
      "path": "annex/part/B/division/8/division/1",
      "kind": "division",
      "number": null,
      "heading": "Introduction",
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      "extent": "E+W+S+N.I.",
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      "parent": "annex/part/B/division/8"
    },
    {
      "path": "annex/part/B/division/8/division/1/division/i",
      "kind": "division",
      "number": "(i)",
      "heading": "The information on identity, biological properties and further information in Sections 1, 2, 3 and 7 is central to the assessment of impact on non-target species. Additional useful information may be found on fate and behaviour in the environment in Section 7 and on residue levels in plants in Section 6 which, together with information on the nature of the preparation and its manner of use, defines the nature and extent of potential exposure. The information submitted in accordance with Section 5 will provide essential information as to effects to mammals and the mechanisms involved.",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-1/division-i",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/1"
    },
    {
      "path": "annex/part/B/division/8/division/1/division/ii",
      "kind": "division",
      "number": "(ii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-1/division-ii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/1"
    },
    {
      "path": "annex/part/B/division/8/division/1/division/iii",
      "kind": "division",
      "number": "(iii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-1/division-iii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/1"
    },
    {
      "path": "annex/part/B/division/8/division/1/division/iv",
      "kind": "division",
      "number": "(iv)",
      "heading": "In particular, the information provided for the micro-organism, together with other relevant information, and that provided for one or more preparations containing it, shall be sufficient to:",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-1/division-iv",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/1"
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    {
      "path": "annex/part/B/division/8/division/1/division/v",
      "kind": "division",
      "number": "(v)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-1/division-v",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/1"
    },
    {
      "path": "annex/part/B/division/8/division/1/division/vi",
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      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-1/division-vi",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/1"
    },
    {
      "path": "annex/part/B/division/8/division/1/division/vii",
      "kind": "division",
      "number": "(vii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-1/division-vii",
      "extent": "E+W+S+N.I.",
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    {
      "path": "annex/part/B/division/8/division/1/division/viii",
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      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-1/division-viii",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/1"
    },
    {
      "path": "annex/part/B/division/8/division/1/division/ix",
      "kind": "division",
      "number": "(ix)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-1/division-ix",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/1"
    },
    {
      "path": "annex/part/B/division/8/division/8.1",
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      "number": "8.1",
      "heading": "Effects on birds",
      "url": null,
      "extent": "E+W+S+N.I.",
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      "parent": "annex/part/B/division/8"
    },
    {
      "path": "annex/part/B/division/8/division/8.1/division/1",
      "kind": "division",
      "number": null,
      "heading": "Aim of the test",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-8.1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/8.1"
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    {
      "path": "annex/part/B/division/8/division/8.2",
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      "number": "8.2",
      "heading": "Effects on aquatic organisms",
      "url": null,
      "extent": "E+W+S+N.I.",
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    },
    {
      "path": "annex/part/B/division/8/division/8.2/division/1",
      "kind": "division",
      "number": null,
      "heading": "Aim of the test",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-8.2/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/8.2"
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    {
      "path": "annex/part/B/division/8/division/8.2/division/8.2.1",
      "kind": "division",
      "number": "8.2.1",
      "heading": "Effects on fish",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/8.2"
    },
    {
      "path": "annex/part/B/division/8/division/8.2/division/8.2.1/division/1",
      "kind": "division",
      "number": null,
      "heading": "Aim of the test",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-8.2/division-8.2.1/division-1",
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      "status": null,
      "parent": "annex/part/B/division/8/division/8.2/division/8.2.1"
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    {
      "path": "annex/part/B/division/8/division/8.2/division/8.2.2",
      "kind": "division",
      "number": "8.2.2",
      "heading": "Effects on freshwater invertebrates",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/8.2"
    },
    {
      "path": "annex/part/B/division/8/division/8.2/division/8.2.2/division/1",
      "kind": "division",
      "number": null,
      "heading": "Aim of the test",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-8.2/division-8.2.2/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/8.2/division/8.2.2"
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    {
      "path": "annex/part/B/division/8/division/8.2/division/8.2.3",
      "kind": "division",
      "number": "8.2.3",
      "heading": "Effects on algae growth",
      "url": null,
      "extent": "E+W+S+N.I.",
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      "parent": "annex/part/B/division/8/division/8.2"
    },
    {
      "path": "annex/part/B/division/8/division/8.2/division/8.2.3/division/1",
      "kind": "division",
      "number": null,
      "heading": "Aim of the test",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-8.2/division-8.2.3/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/8.2/division/8.2.3"
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    {
      "path": "annex/part/B/division/8/division/8.2/division/8.2.4",
      "kind": "division",
      "number": "8.2.4",
      "heading": "Effects on plants other than algae",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/8.2"
    },
    {
      "path": "annex/part/B/division/8/division/8.2/division/8.2.4/division/1",
      "kind": "division",
      "number": null,
      "heading": "Aim of the test",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-8.2/division-8.2.4/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/8.2/division/8.2.4"
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    {
      "path": "annex/part/B/division/8/division/8.3",
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      "number": "8.3",
      "heading": "Effects on bees",
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      "extent": "E+W+S+N.I.",
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    },
    {
      "path": "annex/part/B/division/8/division/8.3/division/1",
      "kind": "division",
      "number": null,
      "heading": "Aim of the test",
      "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-8/division-8.3/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/8/division/8.3"
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    {
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