{
  "url": "https://openlegislation.uk/eu-regulation-2012-528/annex-II/title-n11/division-1",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-528/annex-II/title-n11/division-1.json",
  "legislation": "eur/2012/528",
  "legislation_title": "Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2012-528",
  "path": "annex/II/title/n11/division/1",
  "kind": "division",
  "number": null,
  "heading": "Core data set and additional data set for active substances",
  "text": "Information required to support the approval of an active substance is listed in the table below.\nConditions for not requiring a specific test that are set out in the appropriate test methods in Regulation (EC) No 440/2008 that are not repeated in column 3, also apply.\nColumn 1\nInformation required\nColumn 2\nAll data is CDS unless indicated as ADS\nColumn 3\nSpecific rules for adaption from Column 1\n1. APPLICANT\n1.1.\nName and address\n1.2.\nContact person\n1.3.\nManufacturer (name, address and location of manufacturing plant)\n2. IDENTITY OF THE MICRO-ORGANISM\n2.1.\nCommon name of the micro-organism (including alternative and superseded names)\n2.2.\nTaxonomic name and strain\n2.3.\nCollection and culture reference number where the culture is deposited\n2.4\nSpecification of the technical grade active ingredient.\n2.4.1\nContent of the active micro-organism and identity and content of relevant metabolites or toxins.\n2.4.2\nIdentity and content of impurities, additives, contaminating micro-organisms.\n2.4.3\nAnalytical profile of batches.\n2.5\nMethod of production and quality control.\n2.6.\n...\n2.7.\n...\n2.8.\n...\n2.9.\n...\n3. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM\n3.1. General information on the micro-organism\n3.1.1.\nHistorical background\n3.1.2.\nHistorical uses\n3.1.3.\nOrigin, natural occurrence and geographical distribution\n3.2.\nDevelopment stages/life cycle of the micro-organism\n3.3.\nRelationships to known plant or animal or human pathogens\n3.4.\nGenetic stability and factors affecting it\n3.5\nInformation on the production of relevant metabolites and toxins.\n3.6.\nProduction and resistance to antibiotics and other anti-microbial agents\n3.7.\nRobustness to environmental factors\n3.8.\nFurther information on the micro-organism\n4. METHODS OF DETECTION AND IDENTIFICATION\n4.1\nMethods, procedures and criteria used to establish the presence and identity of the micro-organism.\n4.2\nAnalytical methods for the analysis of the micro-organism as manufactured.\n4.3\nMethods used for monitoring purposes to determine and quantify residues (viable or non-viable).\n5. EFFECTIVENESS AGAINST TARGET ORGANISM\n5.1.\nFunction and mode of control e.g. attracting, killing, inhibiting\n5.2.\nInfectiveness, dispersal and colonisation ability\n5.3.\nRepresentative organism(s) controlled and products, organisms or objects to be protected\n5.4.\nEffects on representative target organism(s)\nEffects on materials, substances and products\n5.5.\nLikely concentration at which the micro-organism will be used\n5.6.\nMode of action (including time delay)\n5.7.\nEfficacy data\n5.8. Any known limitations on efficacy\n5.8.1.\nInformation on the occurrence or possible occurrence of the development of resistance of the target organism(s) and appropriate management strategies\n5.8.2.\nObservations on undesirable or unintended side effects\n5.8.3.\nHost specificity, range and effects on species other than the target organism\n5.9.\nMethods to prevent loss of virulence of seed stock of the micro-organism\n6. INTENDED USES AND EXPOSURE\n6.1.\nField of use(s) envisaged\n6.2.\nProduct-type(s)\n6.3.\nDetailed description of the use pattern(s)\n6.4.\nCategory of users for which the micro-organism should be approved\n6.5. Exposure data applying, as appropriate, the methodologies described in Section 5 of Annex I to Regulation (EC) No 1907/2006\n6.5.1.\nInformation on human exposure associated with the intended uses and disposal of the active substance\n6.5.2.\nInformation on environmental exposure associated with the intended uses and disposal of the active substance\n6.5.3.\nInformation on exposure of food-producing animals and food and feeding stuffs associated with the intended uses of the active substance\n7.\nEFFECT ON HUMAN AND ANIMAL HEALTH\nInformation requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex.\n7.1. Basic information\n7.1.1.\nMedical data\n7.1.2.\nMedical surveillance on manufacturing plant personnel\n7.1.3.\nSensitisation/allergenicity observations\n7.1.4.\nDirect observation, e.g. clinical cases\nAny pathogenicity and infectiveness to humans and other mammals under conditions of immunosuppression\n7.2. Basic studies\n7.2.1.\nSensitisation\n7.2.2. Acute toxicity, pathogenicity, and infectiveness\n7.2.2.1.\nAcute oral toxicity, pathogenicity and infectiveness\n7.2.2.2.\nAcute inhalatory toxicity, pathogenicity and infectiveness\nADS\n7.2.2.3.\nIntraperitoneal/subcutaneous single dose\nADS\n7.2.3.\nIn vitro genotoxicity testing\n7.2.4.\nCell culture study\n7.2.5.\nInformation on short-term toxicity and pathogenicity\nADS\n7.2.5.1.\nHealth effects after repeated inhalatory exposure\nADS\n7.2.6.\nProposed treatment: first aid measures, medical treatment\n7.3.\nSpecific toxicity, pathogenicity and infectiveness studies\nADS\n7.4.\nGenotoxicity — in vivo studies in somatic cells\nADS\n7.5.\nGenotoxicity — in vivo studies in germ cells\nADS\n7.6.\nSummary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation\n7.7.\nResidues in or on treated articles, food and feedingstuffs\nADS\n7.7.1.\nPersistence and likelihood of multiplication in or on treated articles, feedingstuffs or foodstuffs\nADS\n7.7.2.\nFurther information required\nADS\n7.7.2.1.\nNon-viable residues\nADS\n7.7.2.2.\nViable residues\nADS\n7.8.\nSummary and evaluation of residues in or on treated articles, food and feedingstuffs\nADS\n8.\nEFFECTS ON NON-TARGET ORGANISMS\nInformation requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex.\n8.1. Effects on aquatic organisms\n8.1.1.\nEffects on fish\n8.1.2.\nEffects on freshwater invertebrates\n8.1.3.\nEffects on algae growth\n8.1.4.\nEffects on plants other than algae\nADS\n8.2.\nEffects on earthworms\n8.3.\nEffects on soil micro-organisms\n8.4.\nEffects on birds\n8.5.\nEffects on bees\n8.6.\nEffects on arthropods other than bees\n8.7.\nFurther studies\nADS\n8.7.1.\nTerrestrial plants\nADS\n8.7.2.\nMammals\nADS\n8.7.3.\nOther relevant species and processes\nADS\n8.8.\nSummary and evaluation of effects on non-target organisms\n9. ENVIRONMENTAL FATE AND BEHAVIOUR\n9.1. Persistence and multiplication\n9.1.1.\nSoil\n9.1.2.\nWater\n9.1.3.\nAir\n9.1.4.\nMobility\n9.1.5.\nSummary and evaluation of fate and behaviour in the environment\n10. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT\n10.1.\nRecommended methods and precautions concerning handling, storage, transport or fire\n10.2.\nEmergency measures in case of an accident\n10.3.\nProcedures for destruction or decontamination\n10.4.\nProcedures for waste management\n10.5.\nMonitoring plan to be used for the active micro-organism including handling, storage, transport and use\n11. CLASSIFICATION, LABELLING AND PACKAGING OF THE MICRO-ORGANISM\n11.1.\nRelevant risk group specified in Article 2 of Directive 2000/54/EC\n12.\nSUMMARY AND EVALUATION\nThe key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Annex 2 Title 2 table substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(a) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Annex 2 Title 2 table row 2.4 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(b) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Annex 2 Title 2 table rows 2.4.1-2.4.3 inserted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(c) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Annex 2 Title 2 table row 2.5 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(d) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Annex 2 Title 2 table rows 2.6-2.9 omitted (6.4.2024) by virtue of The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(e) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Annex 2 Title 2 table row 3.5 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(f) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Annex 2 Title 2 table row 4.1 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(g) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Annex 2 Title 2 table row 4.2 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(h) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Annex 2 Title 2 table row 4.3 inserted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(i) (with reg. 3)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2012/528/annex/II/title/n11/division/1",
    "retrieved_at": "2026-11-01T14:49:22.826342+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."
}