{
  "url": "https://openlegislation.uk/eu-regulation-2013-283",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-283.json",
  "id": "eur/2013/283",
  "title": "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)",
  "short_title": "Regulation (EU) No 283/2013 setting out the data requirements for active substances, in accordance with…",
  "long_title": "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)",
  "citation": "EU Regulation No 283/2013",
  "type": "eur",
  "year": "2013",
  "number": "283",
  "version": "current",
  "date": "2013-03-01",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 1,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Data requirements for active substances",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Repeal",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/article-2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Transitional measures as regards procedures concerning active substances",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/article-3",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Transitional measures as regards procedures concerning plant protection products",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/article-4",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Entry into force and date of application",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/article-5",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex",
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      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "annex/division/INTRODUCTION",
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      "status": null,
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    },
    {
      "path": "annex/division/INTRODUCTION/division/1",
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      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/division-INTRODUCTION/division-1",
      "extent": "E+W+S+N.I.",
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      "parent": "annex/division/INTRODUCTION"
    },
    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.1",
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    },
    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.2",
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    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.3",
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      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/INTRODUCTION/division/1"
    },
    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.4",
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      "number": "1.4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/division-INTRODUCTION/division-1/division-1.4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/INTRODUCTION/division/1"
    },
    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.5",
      "kind": "division",
      "number": "1.5",
      "heading": "The information shall include a full and unbiased report of the studies conducted as well as a full description of them. Such information shall not be required, where one of the following conditions is fulfilled:",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/division-INTRODUCTION/division-1/division-1.5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/INTRODUCTION/division/1"
    },
    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.6",
      "kind": "division",
      "number": "1.6",
      "heading": "The simultaneous use of the active substance as a biocide or in veterinary medicine shall be reported.",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/division-INTRODUCTION/division-1/division-1.6",
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      "status": null,
      "parent": "annex/division/INTRODUCTION/division/1"
    },
    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.7",
      "kind": "division",
      "number": "1.7",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/division-INTRODUCTION/division-1/division-1.7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/INTRODUCTION/division/1"
    },
    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.8",
      "kind": "division",
      "number": "1.8",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/division-INTRODUCTION/division-1/division-1.8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/INTRODUCTION/division/1"
    },
    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.9",
      "kind": "division",
      "number": "1.9",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/division-INTRODUCTION/division-1/division-1.9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/INTRODUCTION/division/1"
    },
    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.10",
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      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/division-INTRODUCTION/division-1/division-1.10",
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    },
    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.11",
      "kind": "division",
      "number": "1.11",
      "heading": "The information on the active substance, taken together with the information concerning one or more plant protection products containing the active substance and together, if appropriate, with the information concerning safeners and synergists and other components of the plant protection product, shall be sufficient to:",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/division-INTRODUCTION/division-1/division-1.11",
      "extent": "E+W+S+N.I.",
      "status": null,
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      "path": "annex/division/INTRODUCTION/division/1/division/1.12",
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      "path": "annex/division/INTRODUCTION/division/1/division/1.13",
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    {
      "path": "annex/division/INTRODUCTION/division/1/division/1.14",
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    {
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      "parent": "annex/division/INTRODUCTION"
    },
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      "path": "annex/division/INTRODUCTION/division/3",
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      "heading": "Good laboratory practice (GLP)",
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      "extent": "E+W+S+N.I.",
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    },
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      "heading": "By way of derogation from point 3.1:",
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    },
    {
      "path": "annex/division/INTRODUCTION/division/5",
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      "extent": "E+W+S+N.I.",
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      "path": "annex/division/INTRODUCTION/division/6",
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    },
    {
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      "heading": "CHEMICAL ACTIVE SUBSTANCES",
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      "status": null,
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    {
      "path": "annex/section/1",
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      "heading": "Identity of the active substance",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-1",
      "extent": "E+W+S+N.I.",
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      "parent": "annex/part/A"
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      "heading": "Applicant",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-1/division-1.1",
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      "heading": "Common name proposed or ISO-accepted, and synonyms",
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      "heading": "Chemical name (IUPAC and CA nomenclature)",
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      "heading": "Producer's development code numbers",
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      "extent": "E+W+S+N.I.",
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      "path": "annex/section/1/division/1.6",
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      "heading": "CAS, EC and CIPAC numbers",
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      "extent": "E+W+S+N.I.",
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    },
    {
      "path": "annex/section/1/division/1.7",
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      "number": "1.7",
      "heading": "Molecular and structural formula, molar mass",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-1/division-1.7",
      "extent": "E+W+S+N.I.",
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    },
    {
      "path": "annex/section/1/division/1.8",
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      "heading": "Method of manufacture (synthesis pathway) of the active substance",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-1/division-1.8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/1"
    },
    {
      "path": "annex/section/1/division/1.9",
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      "number": "1.9",
      "heading": "Specification of purity of the active substance in g/kg",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-1/division-1.9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/1"
    },
    {
      "path": "annex/section/1/division/1.10",
      "kind": "division",
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      "heading": "Identity and content of additives (such as stabilisers) and impurities",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-1/division-1.10",
      "extent": "E+W+S+N.I.",
      "status": null,
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    {
      "path": "annex/section/1/division/1.10/division/1.10.1",
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      "heading": "Additives",
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      "parent": "annex/section/1/division/1.10"
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      "path": "annex/section/1/division/1.10/division/1.10.2",
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      "heading": "Significant impurities",
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    },
    {
      "path": "annex/section/1/division/1.10/division/1.10.3",
      "kind": "division",
      "number": "1.10.3",
      "heading": "Relevant impurities",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-1/division-1.10/division-1.10.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/1/division/1.10"
    },
    {
      "path": "annex/section/1/division/1.11",
      "kind": "division",
      "number": "1.11",
      "heading": "Analytical profile of batches",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-1/division-1.11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/1"
    },
    {
      "path": "annex/section/2",
      "kind": "section",
      "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/section/2/division/2.1",
      "kind": "division",
      "number": "2.1",
      "heading": "Melting point and boiling point",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.2",
      "kind": "division",
      "number": "2.2",
      "heading": "Vapour pressure, volatility",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.3",
      "kind": "division",
      "number": "2.3",
      "heading": "Appearance (physical state, colour)",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.4",
      "kind": "division",
      "number": "2.4",
      "heading": "Spectra (UV/VIS, IR, NMR, MS), molar extinction at relevant wavelengths, optical purity",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.5",
      "kind": "division",
      "number": "2.5",
      "heading": "Solubility in water",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.6",
      "kind": "division",
      "number": "2.6",
      "heading": "Solubility in organic solvents",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.7",
      "kind": "division",
      "number": "2.7",
      "heading": "Partition coefficient n-octanol/water",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.8",
      "kind": "division",
      "number": "2.8",
      "heading": "Dissociation in water",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.9",
      "kind": "division",
      "number": "2.9",
      "heading": "Flammability and self-heating",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.10",
      "kind": "division",
      "number": "2.10",
      "heading": "Flash point",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.11",
      "kind": "division",
      "number": "2.11",
      "heading": "Explosive properties",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.12",
      "kind": "division",
      "number": "2.12",
      "heading": "Surface tension",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.13",
      "kind": "division",
      "number": "2.13",
      "heading": "Oxidising properties",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/2/division/2.14",
      "kind": "division",
      "number": "2.14",
      "heading": "Other studies",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-2/division-2.14",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/2"
    },
    {
      "path": "annex/section/3",
      "kind": "section",
      "number": "3",
      "heading": "Further information on the active substance",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A"
    },
    {
      "path": "annex/section/3/division/3.1",
      "kind": "division",
      "number": "3.1",
      "heading": "Use of the active substance",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-3/division-3.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/3"
    },
    {
      "path": "annex/section/3/division/3.2",
      "kind": "division",
      "number": "3.2",
      "heading": "Function",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-3/division-3.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/3"
    },
    {
      "path": "annex/section/3/division/3.3",
      "kind": "division",
      "number": "3.3",
      "heading": "Effects on harmful organisms",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-3/division-3.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/3"
    },
    {
      "path": "annex/section/3/division/3.4",
      "kind": "division",
      "number": "3.4",
      "heading": "Field of use envisaged",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-3/division-3.4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/3"
    },
    {
      "path": "annex/section/3/division/3.5",
      "kind": "division",
      "number": "3.5",
      "heading": "Harmful organisms controlled and crops or products protected or treated",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-3/division-3.5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/3"
    },
    {
      "path": "annex/section/3/division/3.6",
      "kind": "division",
      "number": "3.6",
      "heading": "Mode of action",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-3/division-3.6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/3"
    },
    {
      "path": "annex/section/3/division/3.7",
      "kind": "division",
      "number": "3.7",
      "heading": "Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-3/division-3.7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/3"
    },
    {
      "path": "annex/section/3/division/3.8",
      "kind": "division",
      "number": "3.8",
      "heading": "Methods and precautions concerning handling, storage, transport or fire",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-3/division-3.8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/3"
    },
    {
      "path": "annex/section/3/division/3.9",
      "kind": "division",
      "number": "3.9",
      "heading": "Procedures for destruction or decontamination",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-3/division-3.9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/3"
    },
    {
      "path": "annex/section/3/division/3.10",
      "kind": "division",
      "number": "3.10",
      "heading": "Emergency measures in case of an accident",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-3/division-3.10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/3"
    },
    {
      "path": "annex/section/4",
      "kind": "section",
      "number": "4",
      "heading": "Analytical methods",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A"
    },
    {
      "path": "annex/section/4/division/1",
      "kind": "division",
      "number": null,
      "heading": "Introduction",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-4/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/4"
    },
    {
      "path": "annex/section/4/division/4.1",
      "kind": "division",
      "number": "4.1",
      "heading": "Methods used for the generation of pre-approval data",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/4"
    },
    {
      "path": "annex/section/4/division/4.1/division/4.1.1",
      "kind": "division",
      "number": "4.1.1",
      "heading": "Methods for the analysis of the active substance as manufactured",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-4/division-4.1/division-4.1.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/4/division/4.1"
    },
    {
      "path": "annex/section/4/division/4.1/division/4.1.2",
      "kind": "division",
      "number": "4.1.2",
      "heading": "Methods for risk assessment",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-4/division-4.1/division-4.1.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/4/division/4.1"
    },
    {
      "path": "annex/section/4/division/4.2",
      "kind": "division",
      "number": "4.2",
      "heading": "Methods for post-approval control and monitoring purposes",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-4/division-4.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/4"
    },
    {
      "path": "annex/section/5",
      "kind": "section",
      "number": "5",
      "heading": "Toxicological and metabolism studies",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A"
    },
    {
      "path": "annex/section/5/division/1",
      "kind": "division",
      "number": null,
      "heading": "Introduction",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5"
    },
    {
      "path": "annex/section/5/division/1/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/1"
    },
    {
      "path": "annex/section/5/division/1/division/2",
      "kind": "division",
      "number": "2",
      "heading": "All potentially adverse effects found during toxicological investigations (including effects on organs/systems such as the immune system, the nervous system, or the endocrine system) shall be reported. Additional studies may be necessary to investigate the mechanisms underlying effects that could be critical to hazard identification or risk assessment.",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-1/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/1"
    },
    {
      "path": "annex/section/5/division/1/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-1/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/1"
    },
    {
      "path": "annex/section/5/division/1/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-1/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/1"
    },
    {
      "path": "annex/section/5/division/1/division/5",
      "kind": "division",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-1/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/1"
    },
    {
      "path": "annex/section/5/division/1/division/6",
      "kind": "division",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-1/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/1"
    },
    {
      "path": "annex/section/5/division/1/division/7",
      "kind": "division",
      "number": "7",
      "heading": "Where, as a result of metabolism or other processes in or on treated plants, in livestock, in soil, in ground water, open air, or as a result of processing of treated products, the terminal residue to which humans will be exposed contains a substance which is not the active substance itself and is not identified as a significant metabolite in mammals, toxicity studies shall, where technically possible, be carried out on that substance unless it can be demonstrated that human exposure to that substance does not constitute a relevant risk to health.",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-1/division-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/1"
    },
    {
      "path": "annex/section/5/division/1/division/8",
      "kind": "division",
      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-1/division-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/1"
    },
    {
      "path": "annex/section/5/division/1/division/9",
      "kind": "division",
      "number": "9",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-1/division-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/1"
    },
    {
      "path": "annex/section/5/division/5.1",
      "kind": "division",
      "number": "5.1",
      "heading": "Studies on absorption, distribution, metabolism and excretion in mammals",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5"
    },
    {
      "path": "annex/section/5/division/5.1/division/5.1.1",
      "kind": "division",
      "number": "5.1.1",
      "heading": "Absorption, distribution, metabolism and excretion after exposure by oral route",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.1/division-5.1.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/5.1"
    },
    {
      "path": "annex/section/5/division/5.1/division/5.1.2",
      "kind": "division",
      "number": "5.1.2",
      "heading": "Absorption, distribution, metabolism and excretion after exposure by other routes",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.1/division-5.1.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/5.1"
    },
    {
      "path": "annex/section/5/division/5.2",
      "kind": "division",
      "number": "5.2",
      "heading": "Acute toxicity",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5"
    },
    {
      "path": "annex/section/5/division/5.2/division/5.2.1",
      "kind": "division",
      "number": "5.2.1",
      "heading": "Oral",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/5.2"
    },
    {
      "path": "annex/section/5/division/5.2/division/5.2.1/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.2/division-5.2.1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/5.2/division/5.2.1"
    },
    {
      "path": "annex/section/5/division/5.2/division/5.2.2",
      "kind": "division",
      "number": "5.2.2",
      "heading": "Dermal",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/5.2"
    },
    {
      "path": "annex/section/5/division/5.2/division/5.2.2/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.2/division-5.2.2/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/5.2/division/5.2.2"
    },
    {
      "path": "annex/section/5/division/5.2/division/5.2.3",
      "kind": "division",
      "number": "5.2.3",
      "heading": "Inhalation",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/5.2"
    },
    {
      "path": "annex/section/5/division/5.2/division/5.2.3/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.2/division-5.2.3/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/5.2/division/5.2.3"
    },
    {
      "path": "annex/section/5/division/5.2/division/5.2.4",
      "kind": "division",
      "number": "5.2.4",
      "heading": "Skin irritation",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.2/division-5.2.4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/5.2"
    },
    {
      "path": "annex/section/5/division/5.2/division/5.2.4/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.2/division-5.2.4/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/5/division/5.2/division/5.2.4"
    },
    {
      "path": "annex/section/5/division/5.2/division/5.2.5",
      "kind": "division",
      "number": "5.2.5",
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      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.2/division-5.2.5",
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      "parent": "annex/section/8/division/1"
    },
    {
      "path": "annex/section/8/division/1/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-1/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/1"
    },
    {
      "path": "annex/section/8/division/1/division/3",
      "kind": "division",
      "number": "3",
      "heading": "It may be necessary to conduct separate studies for metabolites, breakdown or reaction products derived from the active substance where non-target organisms may be exposed and where their effects cannot be evaluated by the available results relating to the active substance. Before such studies are performed, the applicant shall take into account the information from Sections 5, 6 and 7.",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-1/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/1"
    },
    {
      "path": "annex/section/8/division/1/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-1/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/1"
    },
    {
      "path": "annex/section/8/division/1/division/5",
      "kind": "division",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-1/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/1"
    },
    {
      "path": "annex/section/8/division/1/division/6",
      "kind": "division",
      "number": "6",
      "heading": "For those guidelines which allow for the study to be designed to determine an effective concentration (ECx), the study shall be conducted to determine an EC10, EC20 and EC50, when required, along with corresponding 95 % confidence intervals. If an ECx approach is used, a no observed effect concentration (NOEC) shall still be determined.",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-1/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/1"
    },
    {
      "path": "annex/section/8/division/1/division/7",
      "kind": "division",
      "number": "7",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-1/division-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/1"
    },
    {
      "path": "annex/section/8/division/1/division/8",
      "kind": "division",
      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-1/division-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/1"
    },
    {
      "path": "annex/section/8/division/1/division/9",
      "kind": "division",
      "number": "9",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-1/division-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/1"
    },
    {
      "path": "annex/section/8/division/1/division/10",
      "kind": "division",
      "number": "10",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-1/division-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/1"
    },
    {
      "path": "annex/section/8/division/8.1",
      "kind": "division",
      "number": "8.1",
      "heading": "Effects on birds and other terrestrial vertebrates",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.1",
      "kind": "division",
      "number": "8.1.1",
      "heading": "Effects on birds",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.1",
      "kind": "division",
      "number": "8.1.1.1",
      "heading": "Acute oral toxicity to birds",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.1/division-8.1.1.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.1"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.1/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.1/division-8.1.1.1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.1"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.1/division/2",
      "kind": "division",
      "number": null,
      "heading": "Test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.1/division-8.1.1.1/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.1"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.2",
      "kind": "division",
      "number": "8.1.1.2",
      "heading": "Short-term dietary toxicity to birds",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.1/division-8.1.1.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.1"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.2/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.1/division-8.1.1.2/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.2"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.2/division/2",
      "kind": "division",
      "number": null,
      "heading": "Test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.1/division-8.1.1.2/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.2"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.3",
      "kind": "division",
      "number": "8.1.1.3",
      "heading": "Sub-chronic and reproductive toxicity to birds",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.1/division-8.1.1.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.1"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.3/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.1/division-8.1.1.3/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.3"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.3/division/2",
      "kind": "division",
      "number": null,
      "heading": "Test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.1/division-8.1.1.3/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.1/division/8.1.1.3"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.2",
      "kind": "division",
      "number": "8.1.2",
      "heading": "Effects on terrestrial vertebrates other than birds",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.2/division/8.1.2.1",
      "kind": "division",
      "number": "8.1.2.1",
      "heading": "Acute oral toxicity to mammals",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.2/division-8.1.2.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.2"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.2/division/8.1.2.1/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.2/division-8.1.2.1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.2/division/8.1.2.1"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.2/division/8.1.2.2",
      "kind": "division",
      "number": "8.1.2.2",
      "heading": "Long-term and reproductive toxicity to mammals",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.2"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.2/division/8.1.2.2/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.2/division-8.1.2.2/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1/division/8.1.2/division/8.1.2.2"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.3",
      "kind": "division",
      "number": "8.1.3",
      "heading": "Active substance bioconcentration in prey of birds and mammals",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.4",
      "kind": "division",
      "number": "8.1.4",
      "heading": "Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1"
    },
    {
      "path": "annex/section/8/division/8.1/division/8.1.5",
      "kind": "division",
      "number": "8.1.5",
      "heading": "Endocrine disrupting properties",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.1/division-8.1.5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.1"
    },
    {
      "path": "annex/section/8/division/8.2",
      "kind": "division",
      "number": "8.2",
      "heading": "Effects on aquatic organisms",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.1",
      "kind": "division",
      "number": "8.2.1",
      "heading": "Acute toxicity to fish",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.1/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.1"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.1/division/2",
      "kind": "division",
      "number": null,
      "heading": "Test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.1/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.1"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.2",
      "kind": "division",
      "number": "8.2.2",
      "heading": "Long-term and chronic toxicity to fish",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.2/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.2/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.2"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.2/division/8.2.2.1",
      "kind": "division",
      "number": "8.2.2.1",
      "heading": "Fish early life stage toxicity test",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.2/division-8.2.2.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.2"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.2/division/8.2.2.2",
      "kind": "division",
      "number": "8.2.2.2",
      "heading": "Fish full life cycle test",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.2/division-8.2.2.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.2"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.2/division/8.2.2.2/division/1",
      "kind": "division",
      "number": null,
      "heading": "Test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.2/division-8.2.2.2/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.2/division/8.2.2.2"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.2/division/8.2.2.3",
      "kind": "division",
      "number": "8.2.2.3",
      "heading": "Bioconcentration in fish",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.2/division-8.2.2.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.2"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.2/division/8.2.2.3/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.2/division-8.2.2.3/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.2/division/8.2.2.3"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.3",
      "kind": "division",
      "number": "8.2.3",
      "heading": "Endocrine disrupting properties",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.4",
      "kind": "division",
      "number": "8.2.4",
      "heading": "Acute toxicity to aquatic invertebrates",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.4/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.4/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.4"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.4/division/8.2.4.1",
      "kind": "division",
      "number": "8.2.4.1",
      "heading": "Acute toxicity to Daphnia magna",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.4/division-8.2.4.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.4"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.4/division/8.2.4.1/division/1",
      "kind": "division",
      "number": null,
      "heading": "Test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.4/division-8.2.4.1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.4/division/8.2.4.1"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.4/division/8.2.4.2",
      "kind": "division",
      "number": "8.2.4.2",
      "heading": "Acute toxicity to an additional aquatic invertebrate species",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.4/division-8.2.4.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.4"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.4/division/8.2.4.2/division/1",
      "kind": "division",
      "number": null,
      "heading": "Test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.2/division-8.2.4/division-8.2.4.2/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.2/division/8.2.4/division/8.2.4.2"
    },
    {
      "path": "annex/section/8/division/8.2/division/8.2.5",
      "kind": "division",
      "number": "8.2.5",
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      "path": "annex/section/8/division/8.4/division/8.4.2/division/8.4.2.1",
      "kind": "division",
      "number": "8.4.2.1",
      "heading": "Species level testing",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.4/division-8.4.2/division-8.4.2.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.4/division/8.4.2"
    },
    {
      "path": "annex/section/8/division/8.4/division/8.4.2/division/8.4.2.1/division/1",
      "kind": "division",
      "number": null,
      "heading": "Test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.4/division-8.4.2/division-8.4.2.1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.4/division/8.4.2/division/8.4.2.1"
    },
    {
      "path": "annex/section/8/division/8.5",
      "kind": "division",
      "number": "8.5",
      "heading": "Effects on soil nitrogen transformation",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8"
    },
    {
      "path": "annex/section/8/division/8.5/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.5/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.5"
    },
    {
      "path": "annex/section/8/division/8.5/division/2",
      "kind": "division",
      "number": null,
      "heading": "Test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.5/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.5"
    },
    {
      "path": "annex/section/8/division/8.6",
      "kind": "division",
      "number": "8.6",
      "heading": "Effects on terrestrial non-target higher plants",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8"
    },
    {
      "path": "annex/section/8/division/8.6/division/8.6.1",
      "kind": "division",
      "number": "8.6.1",
      "heading": "Summary of screening data",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.6/division-8.6.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.6"
    },
    {
      "path": "annex/section/8/division/8.6/division/8.6.1/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.6/division-8.6.1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.6/division/8.6.1"
    },
    {
      "path": "annex/section/8/division/8.6/division/8.6.1/division/2",
      "kind": "division",
      "number": null,
      "heading": "Test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.6/division-8.6.1/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.6/division/8.6.1"
    },
    {
      "path": "annex/section/8/division/8.6/division/8.6.2",
      "kind": "division",
      "number": "8.6.2",
      "heading": "Testing on non-target plants",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.6/division-8.6.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.6"
    },
    {
      "path": "annex/section/8/division/8.6/division/8.6.2/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.6/division-8.6.2/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.6/division/8.6.2"
    },
    {
      "path": "annex/section/8/division/8.6/division/8.6.2/division/2",
      "kind": "division",
      "number": null,
      "heading": "Test conditions",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.6/division-8.6.2/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.6/division/8.6.2"
    },
    {
      "path": "annex/section/8/division/8.7",
      "kind": "division",
      "number": "8.7",
      "heading": "Effects on other terrestrial organisms (flora and fauna)",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8"
    },
    {
      "path": "annex/section/8/division/8.8",
      "kind": "division",
      "number": "8.8",
      "heading": "Effects on biological methods for sewage treatment",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8"
    },
    {
      "path": "annex/section/8/division/8.8/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.8/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8/division/8.8"
    },
    {
      "path": "annex/section/8/division/8.9",
      "kind": "division",
      "number": "8.9",
      "heading": "Monitoring data",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-8/division-8.9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/section/8"
    },
    {
      "path": "annex/section/9",
      "kind": "section",
      "number": "9",
      "heading": "Literature data",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/A"
    },
    {
      "path": "annex/section/10",
      "kind": "section",
      "number": "10",
      "heading": "Classification and labelling",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-10",
      "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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/annex/part-B/division-2/division-2.7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/2"
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    {
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      "heading": "Methods for the analysis of the micro-organism as manufactured",
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      "parent": "annex/part/B/division/5/division/2/division/5.2/division/5.2.3"
    },
    {
      "path": "annex/part/B/division/5/division/2/division/5.2/division/5.2.3/division/5.2.3.1/division/1",
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      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-5/division-2/division-5.2/division-5.2.3/division-5.2.3.1/division-1",
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    {
      "path": "annex/part/B/division/5/division/2/division/5.2/division/5.2.4",
      "kind": "division",
      "number": "5.2.4",
      "heading": "Cell culture study",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-5/division-2/division-5.2/division-5.2.4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5/division/2/division/5.2"
    },
    {
      "path": "annex/part/B/division/5/division/2/division/5.2/division/5.2.5",
      "kind": "division",
      "number": "5.2.5",
      "heading": "Information on short-term toxicity and pathogenicity",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5/division/2/division/5.2"
    },
    {
      "path": "annex/part/B/division/5/division/2/division/5.2/division/5.2.5/division/1",
      "kind": "division",
      "number": null,
      "heading": "Aim of the test",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-5/division-2/division-5.2/division-5.2.5/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5/division/2/division/5.2/division/5.2.5"
    },
    {
      "path": "annex/part/B/division/5/division/2/division/5.2/division/5.2.5/division/2",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-5/division-2/division-5.2/division-5.2.5/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5/division/2/division/5.2/division/5.2.5"
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      "path": "annex/part/B/division/5/division/2/division/5.2/division/5.2.5/division/5.2.5.1",
      "kind": "division",
      "number": "5.2.5.1",
      "heading": "Health effects after repeated inhalatory exposure",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-5/division-2/division-5.2/division-5.2.5/division-5.2.5.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5/division/2/division/5.2/division/5.2.5"
    },
    {
      "path": "annex/part/B/division/5/division/2/division/5.2/division/5.2.5/division/5.2.5.1/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-5/division-2/division-5.2/division-5.2.5/division-5.2.5.1/division-1",
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      "parent": "annex/part/B/division/5/division/2/division/5.2/division/5.2.5/division/5.2.5.1"
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    {
      "path": "annex/part/B/division/5/division/2/division/5.2/division/5.2.6",
      "kind": "division",
      "number": "5.2.6",
      "heading": "Proposed treatment: first aid measures, medical treatment",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-5/division-2/division-5.2/division-5.2.6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5/division/2/division/5.2"
    },
    {
      "path": "annex/part/B/division/5/division/3",
      "kind": "division",
      "number": null,
      "heading": "TIER II",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/part/B/division/5"
    },
    {
      "path": "annex/part/B/division/5/division/3/division/5.3",
      "kind": "division",
      "number": "5.3",
      "heading": "Specific toxicity, pathogenicity and infectiveness studies",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-5/division-3/division-5.3",
      "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/5.4",
      "kind": "division",
      "number": "5.4",
      "heading": "In vivo studies in somatic 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/5.4/division/1",
      "kind": "division",
      "number": null,
      "heading": "Circumstances in which required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/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-2013-283/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-2013-283/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-2013-283/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"
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    {
      "path": "annex/part/B/division/6/division/1/division/i",
      "kind": "division",
      "number": "(i)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/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-2013-283/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-2013-283/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-2013-283/annex/part-B/division-6/division-6.1",
      "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",
      "kind": "division",
      "number": "6.2",
      "heading": "Further information required",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/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-2013-283/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-2013-283/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"
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    {
      "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"
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    {
      "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.",
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      "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-2013-283/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-2013-283/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-2013-283/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-2013-283/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-2013-283/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",
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      "url": "https://openlegislation.uk/eu-regulation-2013-283/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",
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-7/division-7.1",
      "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-2013-283/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-2013-283/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-2013-283/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-2013-283/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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      "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-2013-283/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-2013-283/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-2013-283/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-2013-283/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"
    },
    {
      "path": "annex/part/B/division/8/division/1/division/v",
      "kind": "division",
      "number": "(v)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/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",
      "kind": "division",
      "number": "(vi)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-8/division-1/division-vi",
      "extent": "E+W+S+N.I.",
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      "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-2013-283/annex/part-B/division-8/division-1/division-vii",
      "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/viii",
      "kind": "division",
      "number": "(viii)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-283/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-2013-283/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",
      "kind": "division",
      "number": "8.1",
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