{
  "url": "https://openlegislation.uk/eu-regulation-2006-1907/annex-IX/division-9",
  "json_url": "https://openlegislation.uk/eu-regulation-2006-1907/annex-IX/division-9.json",
  "legislation": "eur/2006/1907",
  "legislation_title": "Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2006-1907",
  "path": "annex/IX/division/9",
  "kind": "division",
  "number": "9",
  "heading": "ECOTOXICOLOGICAL INFORMATION",
  "text": "COLUMN 1 STANDARD INFORMATION REQUIRED\nCOLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1\n9.1.\nAquatic toxicity\n9.1.\nLong-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.\n9.1.5.\nLong-term toxicity testing on invertebrates (preferred species Daphnia ), (unless already provided as part of Annex VII requirements)\n9.1.6.\nLong-term toxicity testing on fish, (unless already provided as part of Annex VIII requirements)\nThe information shall be provided for one of the Sections 9.1.6.1, 9.1.6.2 or 9.1.6.3.\n9.1.6.1.\nFish early-life stage (FELS) toxicity test\n9.1.6.2.\nFish short-term toxicity test on embryo and sac-fry stages\n9.1.6.3.\nFish, juvenile growth test\n9.2.\nDegradation\n9.2.\nFurther biotic degradation testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil).\n9.2.1.\nBiotic\n9.2.1.2.\nSimulation testing on ultimate degradation in surface water\n9.2.1.2.\nThe study need not be conducted if:\nthe substances is highly insoluble in water, or\nthe substance is readily biodegradable.\nFor nanoforms, the study may not be waived on the basis of high insolubility in water alone.\n9.2.1.3.\nSoil simulation testing (for substances with a high potential for adsorption to soil)\n9.2.1.3.\nThe study need not be conducted:\nif the substance is readily biodegradable, or\nif direct and indirect exposure of soil is unlikely.\n9.2.1.4.\nSediment simulation testing (for substances with a high potential for adsorption to sediment)\n9.2.1.4.\nThe study need not be conducted:\nif the substance is readily biodegradable, or\nif direct and indirect exposure of sediment is unlikely.\n9.2.3.\nIdentification of degradation products\n9.2.3.\nUnless the substance is readily biodegradable\n9.3.\nFate and behaviour in the environment\n9.3.2.\nBioaccumulation in aquatic species, preferably fish\n9.3.2.\nThe study need not be conducted if:\nthe substance has a low potential for bioaccumulation (for instance a log Kow ≤ 3) and/or a low potential to cross biological membranes, or\ndirect and indirect exposure of the aquatic compartment is unlikely.\nFor nanoforms, use of any physicochemical property (e.g. octanol water partition coefficient, dissolution rate, dispersion stability) as a reason for waiving the study shall include adequate justification of its relevance to low potential for bioaccumulation or unlikely direct and indirect exposure of the aquatic compartment.\n9.3.3.\nFurther information on adsorption/desorption depending on the results of the study required in Annex VIII\n9.3.3.\nThe study need not be conducted if:\nbased on the physicochemical properties, the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient), or\nthe substance and its degradation products decompose rapidly.\nFor nanoforms, use of any physicochemical property (e.g. octanol water partition coefficient, dissolution rate, dispersion stability) as a reason for waiving the study shall include adequate justification of its relevance to low potential for adsorption.\n9.4.\nEffects on terrestrial organisms\n9.4.\nThese studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.\nIn the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. Where the equilibrium partitioning method is applied to nanoforms, this shall be scientifically justified.\nThe choice of the appropriate tests depends on the outcome of the chemical safety assessment.\nIn particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall consider long-term toxicity testing instead of short-term.\n9.4.1.\nShort-term toxicity to invertebrates\n9.4.2.\nEffects on soil micro-organisms\n9.4.3.\nShort-term toxicity to plants",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Text with EEA relevance)."
    },
    {
      "type": "X",
      "label": "X1",
      "text": "Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2006/1907/annex/IX/division/9",
    "retrieved_at": "2026-11-01T14:53:13.283023+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}