{
  "url": "https://openlegislation.uk/eu-regulation-2012-528/annex-III/title-n11/division-1",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-528/annex-III/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/III/title/n11/division/1",
  "kind": "division",
  "number": null,
  "heading": "Core data set and additional data set",
  "text": "Information required to support the authorisation of a biocidal product is listed in the table below.\nFor each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall 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 and formulator of the biocidal product and the micro-organism(s) (names, addresses, including location of plant(s))\n2. IDENTITY OF THE BIOCIDAL PRODUCTS\n2.1.\nTrade name or proposed trade name\n2.2.\nManufacturer’s development code and number of the biocidal product, if appropriate\n2.3\nDetailed quantitative (g/kg, g/l, % w/w (v/v), cfu/g, cfu/l or IU/mg or any other appropriate unit) and qualitative information on the constitution, composition and function of the biocidal product, e.g. micro-organism, active substances and non-active substances and any other relevant components.\nAll relevant information on individual ingredients and the final composition of the biocidal product must be given.\n2.4.\nFormulation type and nature of the biocidal product\n2.5.\nWhere the biocidal product contains an active substance that has been manufactured in locations or according to processes or from starting materials other than those of the active substance evaluated for the purpose of approval pursuant to Article 9 of this Regulation, evidence has to be provided that technical equivalence has been established in accordance with Article 54 of this Regulation or has been established, following an evaluation having started before 1 September 2013, by a competent authority designated in accordance with Article 26 of Directive 98/8/EC\n3. BIOLOGICAL, PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT\n3.1.\nBiological properties of the micro-organism in the biocidal product\n3.2. Appearance (at 20 °C and 101,3 kPa)\n3.2.1.\nColour (at 20 °C and 101,3 kPa)\n3.2.2.\nOdour (at 20 °C and 101,3 kPa)\n3.3.\nAcidity, alkalinity and pH value\n3.4.\nRelative density\n3.5. Storage stability, stability and shelf-life\n3.5.1.\nEffects of light\n3.5.2.\nEffects of temperature and humidity\n3.5.3.\nReactivity towards the container\n3.5.4.\nOther factors affecting stability\n3.6. Technical characteristics of the biocidal product\n3.6.1.\nWettability\n3.6.2.\nSuspensibility and suspension stability\n3.6.3.\nWet sieve analysis and dry sieve test\n3.6.4.\nEmulsifiability, re-emulsifiability, emulsion stability\n3.6.5.\nParticle size distribution content of dust/fines, attrition and friability\n3.6.6.\nPersistent foaming\n3.6.7.\nFlowability/Pourability/Dustability\n3.6.8\nSpraying patterns – aerosols\n3.6.9\nOther technical characteristics\n3.6.10.\n...\n3.6.11.\n...\n3.6.12.\n...\n3.7. Physical, chemical and biological compatibility with other products including biocidal products with which its use is to be authorised or registered\n3.7.1.\nPhysical compatibility\n3.7.2.\nChemical compatibility\n3.7.3.\nBiological compatibility\n3.8.\nSurface tension\n3.9.\nViscosity\n4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS\n4.1\nExplosives\n4.2\nFlammable aerosols\n4.3\nFlammable liquids\n4.4\nFlammable solids\n4.5\nOxidising liquids\n4.6\nOxidising solids\n4.7\nCorrosive to metals\n4.8\nOther physical indications of hazard\n4.8.1\nAuto-ignition temperatures of products (liquids and gases)\n4.8.2\nRelative self-ignition temperature for solids\n4.8.3\nDust explosion hazard\n...\n5. METHODS OF DETECTION AND IDENTIFICATION\n5.1.\nAnalytical method for determining the concentration of the micro-organism(s) and substances of concern in the biocidal product\n5.2.\nAnalytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance nor the article treated with it does not come into contact with food-producing animals, food of plant and animal origin or feeding stuffs)\nADS\n6. EFFECTIVENESS AGAINST TARGET ORGANISM\n6.1.\nFunction and mode of control\n6.2.\nRepresentative pest organism(s) to be controlled and products, organisms or objects to be protected\n6.3.\nEffects on representative target organisms\n6.4.\nLikely concentration at which micro-organism will be used\n6.5.\nMode of action\n6.6.\nThe proposed label claims for the product\n6.7.\nEfficacy data to support these claims, including any available standard protocols, laboratory tests, or field trials used including performance standards, where appropriate and relevant\n6.8. Any other known limitations on efficacy including resistance\n6.8.1.\nInformation on the occurrence or possible occurrence of the development of resistance and appropriate management strategies\n6.8.2.\nObservations on undesirable or unintended side effects\n7. INTENDED USES AND EXPOSURE\n7.1.\nField of use envisaged\n7.2.\nProduct-type\n7.3.\nDetailed description of intended use\n7.4.\nUser e.g. industrial, trained professional, professional or general public (non-professional)\n7.5.\nMethod of application and a description of this method\n7.6.\nApplication rate and if appropriate the final concentration of the biocidal product or the micro-organism active substance in a treated article or the system in which the product is to be used (e.g. in the application device or bait)\n7.7.\nNumber and timing of applications and duration of protection\nAny particular information relating to the geographical location or climatic variations including necessary waiting periods for re-entry or necessary withdrawal period or other precautions to protect human health, animal health and the environment\n7.8.\nProposed instructions for use\n7.9. Exposure data\n7.9.1.\nInformation on human exposure associated with the proposed/expected uses and disposal\n7.9.2.\nInformation on environmental exposure associated with the proposed/expected uses and disposal\n8.\nTOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS\nTesting on the product/mixture does not need to be conducted if:\nthere are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP) and synergistic effects between any of the components are not expected\n8.1.\nSkin corrosion or irritation\n8.2.\nEye irritation\n8.3.\nSkin sensitisation\n8.4.\nRespiratory sensitisation\nADS\n8.5.\nAcute toxicity\nClassification using the tiered approach to classification of mixtures for acute toxicity in Regulation (EC) No 1272/2008 is the default approach\n8.5.1.\nOral\n8.5.2.\nInhalation\n8.5.3.\nDermal\n8.5.4.\nAdditional acute toxicity studies\n8.6.\nInformation on dermal absorption if required\n8.7.\nAvailable toxicological data relating to:\nnon-active substance(s) (i.e. substance(s) of concern), or\na mixture that a substance(s) of concern is a component of\nIf insufficient data are available for a non-active substance(s) and cannot be inferred through read-across or other accepted non-testing approaches, targeted test(s) described in Annex II, shall be carried out for the substance(s) of concern or a mixture that a substance(s) of concern is a component of\nTesting on the product/mixture does not need to be conducted if:\nthere are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected\n8.8.\nSupplementary studies for combinations of biocidal products\nFor biocidal products that are intended to be authorised for use with other biocidal products, the risks to humans, animals and the environment arising from the use of these product combinations shall be assessed. As an alternative to acute toxicity studies, calculations can be used. In some cases, for example where there are no valid data available of the kind set out in column 3, this may require a limited number of acute toxicity studies to be carried using combinations of the products\nTesting on the mixture of products does not need to be conducted if:\nthere are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected\n8.9.\nResidues in or on treated articles, food and feedingstuffs\nADS\n9. ECOTOXICOLOGICAL STUDIES\n9.1.\nInformation relating to the ecotoxicity of the biocidal product which is sufficient to enable a decision to be made concerning the classification of the product is required\nWhere there are valid data available on each of the components in the mixture and synergistic effects between any of the components are not expected, classification of the mixture can be made according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP)\nWhere valid data on the components are not available or where synergistic effects may be expected then testing of components and/or the biocidal product itself may be necessary\n9.2.\nFurther ecotoxicological studies\nFurther studies chosen from among the endpoints referred to in Section 8 of Annex II ‘Micro-organisms’ for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product\n9.3.\nEffects on any other specific non-target organisms (flora and fauna) believed to be at risk\nADS\nData for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment\n9.4.\nIf the biocidal product is in the form of bait or granules\nADS\n9.4.1.\nSupervised trials to assess risks to non-target organisms under field conditions\n9.4.2.\nStudies on acceptance by ingestion of the biocidal product by any non-target organisms thought to be at risk\n9.5.\nSecondary ecological effect e.g. when a large proportion of a specific habitat type is treated\nADS\n10. ENVIRONMENTAL FATE AND BEHAVIOUR\n10.1.\nForeseeable routes of entry into the environment on the basis of the use envisaged\n10.2.\nFurther studies on fate and behaviour in the environment\nWhere relevant, all the information required in Section 9 of Annex II ‘Micro-organisms’ may be required for the product\nFor products that are used outside, with direct emission to soil, water or surfaces, the components in the product may influence the fate and behaviour (and ecotoxicity) of the active substance. Data are required unless it is scientifically justified that the fate of the components in the product is covered by the data provided for the active substance and other identified substances of concern\nADS\n10.3\nLeaching behaviour or mobility\nADS\n10.4.\nIf the biocidal product is to be sprayed outside or if potential for large scale formation of dust is given then data on overspray behaviour may be required to assess risks to bees under field conditions\nADS\n11. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT\n11.1.\nRecommended methods and precautions concerning: handling, storage, transport or fire\n11.2.\nMeasures in the case of an accident\n11.3. Procedures for destruction or decontamination of the biocidal product and its packaging\n11.3.1.\nControlled incineration\n11.3.2.\nOthers\n11.4.\nPackaging and compatibility of the biocidal product with proposed packaging materials\n11.5.\nProcedures for cleaning application equipment where relevant\n11.6.\nMonitoring plan to be used for the active micro-organism and other micro-organism(s) contained in the biocidal product including handling, storage, transport and use\n12. CLASSIFICATION, LABELLING AND PACKAGING\nExample labels, instructions for use and safety data sheets shall be provided\n12.1.\nIndication on the need for the biocidal product to carry the biohazard sign specified in Annex II to Directive 2000/54/EC\n12.2.\nPrecautionary statements including prevention, response, storage and disposal\n12.3.\nProposals for safety-data sheets should be provided, where appropriate\n12.4.\nPackaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included\n13.\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 3 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. 2 para. 1(6)(a) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Annex 3 Title 2 table row 2.3 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. 2 para. 1(5)(b) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Inserted by Commission Delegated Regulation (EU) No 837/2013 of 25 June 2013 amending Annex III to Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the information requirements for authorisation of biocidal products (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Annex 3 Title 2 table row 3.6.8 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. 2 para. 1(5)(c) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Annex 3 Title 2 table row 3.6.9 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. 2 para. 1(5)(d) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Annex 3 Title 2 table rows 3.6.10-3.6.12 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. 2 para. 1(5)(e) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Annex 3 Title 2 table rows 4.1-4.8.3 substituted for rows 4.1-4.12.3 (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. 2 para. 1(5)(f) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Annex 3 Title 2 table row 10.3 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. 2 para. 1(5)(g) (with reg. 3)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2012/528/annex/III/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."
}