{
  "url": "https://openlegislation.uk/eu-regulation-2012-528/annex-III/title-n10/division-1",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-528/annex-III/title-n10/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/n10/division/1",
  "kind": "division",
  "number": null,
  "heading": "Core data set and additional data set for chemical products",
  "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.\nEye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties.\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, etc.\n1.2.\nContact person\n1.3.\nManufacturer and formulator of the biocidal product and the active substance(s) (names, addresses, including location of plant(s))\n2. IDENTITY OF THE BIOCIDAL PRODUCT\n2.1.\nTrade name or proposed trade name\n2.2.\nManufacturer’s development code and number of the product, if appropriate\n2.3.\nComplete quantitative (g/kg, g/l or % w/w (v/v)) composition of the biocidal product, i.e. declaration of all active substances and non-active substances (substance or mixture according to Article 3 of Regulation (EC) No 1907/2006), which are intentionally added to the biocidal product (formulation) as well as detailed quantitative and qualitative information on the composition of the active substance(s) contained in the biocidal product. For non-active substances, a safety data sheet in compliance with Article 31 of Regulation (EC) No 1907/2006 has to be provided.\nIn addition, all relevant information on individual ingredients, their function and, in the case of a reaction mixture, the final composition of the biocidal product shall be given\n2.4.\nFormulation type and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder, solution\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. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES\n3.1. Appearance (at 20 °C and 101,3 kPa)\n3.1.1.\nPhysical state (at 20 °C and 101,3 kPa)\n3.1.2.\nColour (at 20 °C and 101,3 kPa)\n3.1.3.\nOdour (at 20 °C and 101,3 kPa)\n3.2.\nAcidity/alkalinity\nThe test is applicable when the pH of the biocidal product or its dispersion in water (1 %) is outside the pH range 4-10\n3.3.\nRelative density (liquids) and bulk, tap density (solids)\n3.4. Storage stability, stability and shelf-life\n3.4.1. Storage stability tests\n3.4.1.1.\nAccelerated storage test\n3.4.1.2.\nLong term storage test at ambient temperature\n3.4.1.3.\nLow temperature stability test (liquids)\n3.4.2. Effects on content of the active substance and technical characteristics of the biocidal product\n3.4.2.1.\nLight\n3.4.2.2.\nTemperature and humidity\n3.4.2.3.\nReactivity towards container material\n3.5. Technical characteristics of the biocidal product\n3.5.1.\nWettability\n3.5.2.\nSuspensibility, spontaneity and dispersion stability\n3.5.3.\nWet sieve analysis and dry sieve test\n3.5.4.\nEmulsifiability, re-emulsifiability and emulsion stability\n3.5.5.\nDisintegration time\n3.5.6.\nParticle size distribution, content of dust/fines, attrition, friability\n3.5.7.\nPersistent foaming\n3.5.8.\nFlowability/Pourability/Dustability\n3.5.9.\nBurning rate — smoke generators\n3.5.10.\nBurning completeness — smoke generators\n3.5.11.\nComposition of smoke — smoke generators\n3.5.12.\nSpraying pattern — aerosols\n3.5.13.\nOther technical characteristics\n3.6. Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised\n3.6.1.\nPhysical compatibility\n3.6.2.\nChemical compatibility\n3.7.\nDegree of dissolution and dilution stability\n3.8.\nSurface tension\n3.9.\nViscosity\n4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS\n4.1.\nExplosives\n4.2.\nFlammable gases\n4.3.\nFlammable aerosols\n4.4.\nOxidising gases\n4.5.\nGases under pressure\n4.6.\nFlammable liquids\n4.7.\nFlammable solids\n4.8.\nSelf-reactive substances and mixtures\n4.9.\nPyrophoric liquids\n4.10.\nPyrophoric solids\n4.11.\nSelf-heating substances and mixtures\n4.12.\nSubstances and mixtures which in contact with water emit flammable gases\n4.13.\nOxidising liquids\n4.14.\nOxidising solids\n4.15.\nOrganic peroxides\n4.16.\nCorrosive to metals\n4.17. Additional physical indications of hazard\n4.17.1.\nAuto-ignition temperatures of products (liquids and gases)\n4.17.2.\nRelative self-ignition temperature for solids\n4.17.3.\nDust explosion hazard\n5. METHODS OF DETECTION AND IDENTIFICATION\n5.1.\nAnalytical method including validation parameters for determining the concentration of the active substance(s), residues, relevant impurities and substances of concern in the biocidal product\n5.2.\nIn so far as not covered by Annex II 5.2 and 5.3, analytical methods for monitoring purposes including recovery rates and the limits of determination of relevant components of the biocidal product and/or residues thereof, where relevant in or on the following:\nADS\n5.2.1.\nSoil\nADS\n5.2.2.\nAir\nADS\n5.2.3.\nWater (including drinking water) and sediment\nADS\n5.2.4.\nAnimal and human body fluids and tissues\nADS\n5.3.\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 material treated with it come into contact with food- producing animals, food of plant and animal origin or feeding stuffs)\nADS\n6. EFFECTIVENESS AGAINST TARGET ORGANISMS\n6.1.\nFunction, e.g. fungicide, rodenticide, insecticide, bactericide\nMode of control e.g. attracting, killing, inhibiting\n6.2.\nRepresentative 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 the active substance will be used\n6.5.\nMode of action (including time delay)\n6.6\nThe proposed claims for the product and, where claims are made, for treated articles regarding the biocidal properties conferred to the article.\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 known limitations on efficacy\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 on non-target organisms or on objects and material to be protected.\n6.9.\nSummary and evaluation\n7. INTENDED USES AND EXPOSURE\n7.1.\nField(s) of use envisaged for biocidal products and, where appropriate, treated articles\n7.2.\nProduct-type\n7.3.\nDetailed description of intended use pattern(s) for biocidal products and, where appropriate, treated articles\n7.4.\nUser e.g. industrial, trained professional, professional or general public (non-professional)\n7.5.\nLikely tonnage to be placed on the market per year and, where relevant, for different use categories\n7.6.\nMethod of application and a description of this method\n7.7.\nApplication rate and, if appropriate, the final concentration of the biocidal product and active substance in a treated article or in the system in which the product is to be used, e.g. cooling water, surface water, water used for heating purposes\n7.8.\nNumber and timing of applications, and where relevant, any particular information relating to geographical location or climatic variations including necessary waiting periods, clearance times, withdrawal periods or other precautions to protect human health, animal health and the environment\n7.9.\nProposed instructions for use\n7.10. Exposure data in conformity with Annex VI to this Regulation\n7.10.1.\nInformation on human exposure associated with production and formulation, proposed/expected uses and disposal\n7.10.2.\nInformation on environmental exposure associated with production and formulation, proposed/expected uses and disposal\n7.10.3.\nInformation on exposure from treated articles including leaching data (either laboratory studies or model data)\n7.10.4.\nInformation regarding other products that the product is likely to be used together with, in particular the identity of the active substances in these products, if relevant, and the likelihood of any interactions\n8. TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS\n8.1\nSkin corrosion or irritation.\nThe assessment must comprise the following tiers:\n(a) assessment of the available human, animal and non-animal data;\n(b) skin corrosion, in vitro testing;\n(c) skin irritation, in vitro testing;\n(d) skin corrosion or irritation, in vivo testing.\nTesting of the product or mixture does not need to be conducted if:\n- there are sufficient valid data on each component of the product or mixture to allow its classification in accordance with Regulation (EC) No 1272/2008, and synergistic effects between any of the components are not expected,\n- the product or mixture is a strong acid (pH≤ 2.0) or base (pH≥ 11.5),\n- the product or mixture is spontaneously flammable in air or in contact with water or moisture at room temperature,\n- the product or mixture meets the classification criteria for acute toxicity Category 1 by the dermal route, or\n- an acute toxicity study by the dermal route provides conclusive evidence on skin corrosion or irritation adequate for classification.\nIf results from one of the two studies listed in points (b) or (c) in column 1 of this row already allow a conclusive decision on the classification of product or mixture or on the absence of skin irritation potential, the second study does not need to be conducted.\nAn in vivo study for skin corrosion or irritation must not be conducted unless the in vitro studies listed in points (b) and (c) in column 1 of this row are not applicable, or the results of these studies are not adequate for classification and risk assessment.\nIn vivo studies for skin corrosion or irritation that were initiated before 6th October 2025 will be considered appropriate to address this information requirement only if they lead to a more severe classification than the calculation method of Regulation (EC) No 1272/2008.\n8.2\nSerious eye damage or eye irritation.\nThe assessment must comprise the following tiers:\n(a) assessment of the available human, animal and non-animal data;\n(b) serious eye damage or eye irritation, in vitro testing;\n(c) serious eye damage or eye irritation, in vivo testing.\nTesting on the product or mixture does not need to be conducted if:\n- there are sufficient valid data available on each component of the product or mixture to allow its classification in accordance with Regulation (EC) No 1272/2008, and synergistic effects between any of the components are not expected,\n- the product or mixture is a strong acid (pH≤ 2.0) or base (pH≥ 11.5),\n- the product or mixture is spontaneously flammable in air or in contact with water or moisture at room temperature, or\n- the product or mixture meets the classification criteria for skin corrosion leading to its classification as “serious eye damage” Category 1.\nIf results from a first in vitro study do not allow a conclusive decision on the classification of the product or mixture or on the absence of eye irritation potential, other in vitro studies for this endpoint must be considered.\nAn in vivo study for serious eye damage or eye irritation must not be conducted unless the in vitro studies under point (b) in column 1 of this row are not applicable, or the results obtained from these studies are not adequate for classification and risk assessment.\nIn vivo studies for serious eye damage or eye irritation that were initiated before 6th October 2025 will be considered appropriate to address this information requirement only if they lead to a more severe classification than the calculation method of Regulation (EC) No 1272/2008.\n8.3\nSkin sensitisation.\nThe information must allow a conclusion as to whether the substance is a skin sensitiser and whether it can be presumed to have the potential to produce significant sensitisation in humans (Category 1A). The information should be sufficient to perform a risk assessment where required.\nThe assessment must comprise the following tiers:\n(a) assessment of the available human, animal and non-animal data;\n(b) skin sensitisation, in vitro testing according to OECD TG 497;\n(c) skin sensitisation in vivo testing. The murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing. Another skin sensitisation test may only be used in exceptional circumstances. If another skin sensitisation test is used, scientific justification must be provided.\nTesting on the product or mixture does not need to be conducted if:\n- there are sufficient valid data available on each component of the product or mixture to allow its classification in accordance with Regulation (EC) No 1272/2008, and synergistic effects between any of the components are not expected,\n- the available information indicates that the product or mixture should be classified for skin sensitisation or skin corrosion,\n- the product or mixture is a strong acid (pH≤ 2.0) or base (pH≥ 11.5), or\n- the product or mixture is spontaneously flammable in air or in contact with water or moisture at room temperature.\nIn vitro tests do not need to be conducted if:\n- an in vivo study referred to in point (c) in column 1 of this row is available, or\n- the available in vitro or in chemico test methods of OECD TG 497 are not applicable for the product or mixture or the results obtained from these studies are not adequate for classification and risk assessment.\nAn in vivo study for skin sensitisation must not be conducted unless the in vitro or in chemico studies of OECD TG 497 referred to in point (b) in column 1 of this row are not applicable, or the results obtained from these studies are not adequate for classification and risk assessment and the calculation method or bridging principles laid down in Regulation (EC) No 1272/2008 are not applicable.\nIn vivo studies for skin sensitisation that were initiated before 6th October 2025 will be considered appropriate to address this information requirement.\n8.4.\nRespiratory sensitisation\nADS\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 and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected\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 and should include an assessment of information from in silico approaches.\nTesting on the product/mixture does not need to be conducted if:\n- there 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 Regulation (EC) No 1272/2008, and synergistic effects between any of the components are not expected.\n8.5.1.\nBy oral route\n8.5.2.\nBy inhalation\n8.5.3.\nBy dermal route\n8.5.4.\nFor biocidal products that are intended to be authorised for use with other biocidal products, the risks to human health, animal health 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 out 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 and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected\n8.6.\nInformation on dermal absorption\nInformation on dermal absorption when exposure occurs to the biocidal product. The assessment of this endpoint shall proceed using a tiered approach\n8.7\nAvailable toxicological data relating to:\n(a) a non-active substance or substances (i.e. substance or substances of concern);\n(b) a mixture containing a substance or substances of concern.\nTargeted tests listed in Section 8 of the table in Title 1 of Annex 2 must be carried out, with consideration of reduction of animal use, for the substance or substances of concern or a mixture containing a substance or substances of concern if insufficient data are available and cannot be inferred through read-across, in silico or other accepted non-testing approaches.\nTesting on the product or mixture does not need to be conducted if all of the following conditions are met:\n- there are valid data available on each of the components in the mixture to allow classification of the mixture in accordance with the rules laid down in Regulation (EC) No 1272/2008;\n- a conclusion can be made as to whether the biocidal product can be considered as having endocrine disrupting properties;\n- synergistic effects between any of the components are not expected.\n8.8.\nFood and feedingstuffs studies\nADS\n8.8.1.\nIf residues of the biocidal product remain in or on feedingstuffs for a significant period of time, then feeding and metabolism studies in livestock shall be required to permit evaluation of residues in food of animal origin\nADS\n8.9.\nEffects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the biocidal product\nADS\n8.10.\nOther test(s) related to the exposure to humans\nSuitable test(s) and a reasoned case will be required for the biocidal product\nIn addition, for certain biocides which are applied directly or around livestock (including horses) residue studies might be needed\nADS\n9. ECOTOXICOLOGICAL STUDIES\n9.1\nAvailable ecotoxicological data relating to:\n(a) a non-active substance or substances (i.e. substance or substances of concern);\n(b) a mixture containing a substance or substances of concern.\nTests listed in Section 9 of Title 1 of Annex 2 must be carried out for the substance or substances of concern or a mixture containing a substance or substances of concern if insufficient data are available and cannot be inferred through read-across, in silico or other accepted non-testing approaches.\nTesting on the product or mixture does not need to be conducted if all the following conditions are met:\n- there are valid data available on each of the components in the mixture to allow classification of the mixture in accordance with the rules laid down in Regulation (EC) No 1272/2008;\n- a conclusion can be made as to whether the biocidal product can be considered as having endocrine disrupting properties;\n- synergistic effects between any of the components are not expected.\n9.2.\nFurther Ecotoxicological studies\nFurther studies chosen from among the endpoints referred to in Section 9 of Annex II 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. If the biocidal product is in the form of bait or granules the following studies may be required:\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\nThe test requirements below are applicable only to the relevant components of the biocidal product\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\nFurther studies chosen from among the endpoints referred to in Section 10 of Annex II for relevant components of the biocidal product or the biocidal product itself may be required.\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\nADS\n10.4.\nTesting for distribution and dissipation in the following:\nADS\n10.4.1.\nSoil\nADS\n10.4.2.\nWater and sediment\nADS\n10.4.3.\nAir\nADS\n10.5.\nIf the biocidal product is to be sprayed near to surface waters then an overspray study may be required to assess risks to aquatic organisms or plants under field conditions\nADS\n10.6.\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 and non-target arthropods under field conditions\nADS\n11. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT\n11.1.\nRecommended methods and precautions concerning handling, use, storage, disposal, transport or fire\n11.2.\nIdentity of relevant combustion products in cases of fire\n11.3.\nSpecific treatment in case of an accident, e.g. first-aid measures, antidotes, medical treatment if available; emergency measures to protect the environment\n11.4. Possibility of destruction or decontamination following release in or on the following:\n11.4.1.\nAir\n11.4.2.\nWater, including drinking water\n11.4.3.\nSoil\n11.5.\nProcedures for waste management of the biocidal product and its packaging for industrial use, use by trained professionals, professional users and non-professional users (e.g. possibility of reuse or recycling, neutralisation, conditions for controlled discharge, and incineration)\n11.6.\nProcedures for cleaning application equipment where relevant\n11.7.\nSpecify any repellents or poison control measures included in the product that are present to prevent action against non-target organisms\n12. CLASSIFICATION, LABELLING, AND PACKAGING\nAs established in point (b) of Article 20(1), proposals including justification for the hazard and precautionary statements in accordance with the provisions set in Directive 1999/45/EC and Regulation (EC) No 1272/2008 must be submitted.\nExample labels, instructions for use and safety data sheets shall be provided\n12.1.\nHazard classification\n12.2.\nHazard pictogram\n12.3.\nSignal word\n12.4.\nHazard statements\n12.5.\nPrecautionary statements including prevention, response, storage and disposal\n12.6.\nProposals for safety-data sheets should be provided, where appropriate\n12.7.\nPackaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included\n13.\nEVALUATION AND SUMMARY\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 1 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(5)(a) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F2",
      "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": "F3",
      "text": "Annex 3 Title 1 table row 6.6 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": "F4",
      "text": "Annex 3 Title 1 table row 6.8.2 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. 2 para. 1(5)(c) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Annex 3 Title 1 table row 8.1 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. 2 para. 1(5)(d) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Annex 3 Title 1 table row 8.2 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. 2 para. 1(5)(e) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Annex 3 Title 1 table row 8.3 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)(f) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Annex 3 Title 1 table row 8.5 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. 2 para. 1(5)(g) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Annex 3 Title 1 table row 8.7 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)(h) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Annex 3 Title 1 table row 9.1 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. 2 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/III/title/n10/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."
}