{
  "url": "https://openlegislation.uk/eu-regulation-2012-528/annex-II/title-n10/division-1",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-528/annex-II/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/II/title/n10/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 the Regulation (EC) No 440/2008 and are not repeated in column 3, also apply.\nThe information provided should be for the purified active substance of stated specification or for the active substance as manufactured, if different.\nThe information provided should be for the purified active substance of stated specification.\nOJ L 20, 26.1.1980, p. 43.\nOJ L 372, 27.12.2006, p. 19.\nOJ L 348, 24.12.2008, p. 84.\nColumn 1\nInformation required\nColumn 2\nAll data is CDS unless indicated as ADS\nColumn 3\nSpecific rules for adaptation from Column 1\n1. APPLICANT\n1.1.\nName and address\n1.2.\nContact person\n1.3.\nActive substance manufacturer (name, address and location of manufacturing plant(s))\n2. IDENTITY OF THE ACTIVE SUBSTANCE (AND ITS PRECURSOR OR PRECURSORS IF THE ACTIVE SUBSTANCE IS GENERATED IN SITU)\nFor the active substance and, if applicable, its precursor or precursors, the information given in this Section must be sufficient to enable the active substance to be identified. If it is not technically possible, or if it does not appear scientifically necessary to give the information on one or more of the items listed in this Section, the reasons must be clearly stated.\n2.1.\nCommon name proposed or accepted by ISO and synonyms (usual name, trade name, abbreviation)\n2.2.\nChemical name (IUPAC and CA nomenclature or other international chemical name(s))\n2.3.\nManufacturer’s development code number(s)\n2.4.\nCAS number plus EC, INDEX and CIPAC numbers\n2.5\nMolecular and structural formula (including SMILES notation, if available and appropriate). For precursor or precursors and for active substances generated in situ, information about all generated chemical substances (intended and unintended).\nThe molecular and structural formula does not need to be provided in cases where it is not possible to exactly define the molecular structure of the precursor or the active substance.\n2.6.\nInformation on optical activity and full details of any isomeric composition (if applicable and appropriate)\n2.7.\nMolar mass\n2.8\nMethod of manufacture (syntheses pathways) of active substance including information on starting materials and solvents including suppliers, specifications and commercial availability. For active substances generated in situ, a description of the reaction schemes including all intermediate reactions and their associated chemical substances (intended and unintended) must be provided.\n2.9.\nSpecification of purity of the active substance as manufactured in g/kg, g/l or %w/w (v/v) as appropriate, providing inclusively the upper and lower limit\n2.10.\nThe identity of any impurities and additives including by-products of synthesis, optical isomers, degradation products (if the substance is unstable) un-reacted and end-groups etc. of polymers and un-reacted starting materials of UVC-substances\n2.11.\nAnalytical profile of at least five representative batches (g/kg active substance) including information on content of the impurities referred to in 2.10.\n2.11.1\nAnalytical profile of at least five representative samples taken from the in situ generated substance or substances, providing information on the content of the active substance or substances, any other constituent above 0.1 % w/w, including residues of precursor or precursors, and where relevant any additional impurities referred to in 2.10.\n2.12.\nThe origin of the natural active substance or the precursor(s) of the active substance, e.g. an extract of a flower\n3. PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE\n3.1. Appearance\n3.1.1.\nAggregate state (at 20 °C and 101,3 kPa)\n3.1.2.\nPhysical state (i.e. viscous, crystalline, powder) (at 20 °C and 101,3 kPa)\n3.1.3.\nColour (at 20 °C and 101,3 kPa)\n3.1.4.\nOdour (at 20 °C and 101,3 kPa)\n3.2.\nMelting/freezing point\n3.3.\nAcidity, alkalinity\n3.4.\nBoiling point\n3.5.\nRelative Density\n3.6.\nAbsorption spectra data (UV/VIS, IR, NMR) and a mass spectrum, molar extinction coefficient at relevant wavelengths, where relevant\n3.7. Vapour pressure\n3.7.1.\nHenry’s law constant must always be stated for solids and liquids if it can be calculated\n3.8.\nSurface tension\n3.9.\nWater solubility\n3.10.\nPartition coefficient (n-octanol/water) and its pH dependency\n3.11.\nThermal stability, identity of breakdown products\n3.12.\nReactivity towards container material\n3.13.\nDissociation constant\nADS\n3.14.\nGranulometry\n3.15.\nViscosity\nADS\n3.16.\nSolubility in organic solvents, including effect of temperature on solubility\nADS\n3.17.\nStability in organic solvents used in biocidal products and identity of relevant breakdown products\nADS\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 indicators for hazards\n4.17.1.\nAuto-ignition temperature (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 methods including validation parameters for the determination of active substance as manufactured and where appropriate, for relevant residues, isomers and impurities of the active substance and additives (e.g. stabilisers)\nFor impurities other than relevant impurities this only applies if they are present at ≥ 1 g/kg\n5.2. Analytical methods for monitoring purposes including recovery rates and the limits of quantification and detection for the active substance, and for residues thereof in/on the following where relevant\n5.2.1.\nSoil\n5.2.2.\nAir\n5.2.3.\nWater (surface, drinking etc.) and sediment\n5.2.4.\nAnimal and human body fluids and tissues\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 articles treated with it come into contact with food-producing animals, food of plant or animal origin or feeding stuffs)\nADS\n6. EFFECTIVENESS AGAINST TARGET ORGANISMS\n6.1.\nFunction, e.g. fungicide, rodenticide, insecticide, bactericide and mode 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 organism(s)\n6.4.\nLikely concentration at which the active substance will be used in products and, where appropriate, in treated articles\n6.5.\nMode of action (including time delay)\n6.6\nEfficacy data to support the innate activity of the active substance for the intended use or uses.\nEfficacy data submitted may include any available standard protocols, laboratory tests or field trials and performance standards where appropriate, or data similar to those available for suitable reference products.\n6.7. Any known limitations on efficacy\n6.7.1.\nInformation on the occurrence or possible occurrence of the development of resistance and appropriate management strategies\n6.7.2\nObservations on undesirable or unintended side effects on non-target organisms or on objects and material to be protected.\n7. INTENDED USES AND EXPOSURE\n7.1.\nField of use(s) envisaged for biocidal products and, where appropriate, treated articles\n7.2.\nProduct-type(s)\n7.3.\nDetailed description of the intended use pattern(s) including in treated articles\n7.4.\nUsers 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 the envisaged major use categories\n7.6. Exposure data in conformity with Annex VI to this Regulation\n7.6.1.\nInformation on human exposure associated with the intended uses and disposal of the active substance\n7.6.2.\nInformation on environmental exposure associated with the intended uses and disposal of the active substance\n7.6.3.\nInformation on exposure of food- producing animals and food and feeding stuffs associated with the intended uses of the active substance\n7.6.4.\nInformation on exposure from treated articles including leaching data (either laboratory studies or model data)\n8. TOXICOLOGICAL PROFILE FOR HUMAN AND ANIMAL INCLUDING METABOLISM\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.\nThe studies in column 1 do not need to be conducted if:\n- the available information indicates that the substance meets the criteria for classification for skin corrosion or irritation,\n- the substance is a strong acid (pH≤ 2.0) or base (pH≥ 11.5),\n- the substance is spontaneously flammable in air or in contact with water or moisture at room temperature,\n- the substance 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 point (b) or point (c) in column 1 of this row already allow a conclusive decision on the classification of a substance 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.\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.\nThe studies in column 1 do not need to be conducted if:\n- the available information indicates that the substance meets the criteria for classification for eye irritation or causing serious damage to eyes,\n- the substance is a strong acid (pH≤ 2.0) or base (pH≥ 11.5),\n- the substance is spontaneously flammable in air or in contact with water or moisture at room temperature, or\n- the substance meets the classification criteria for skin corrosion leading to classification of the substance 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 substance 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 listed 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.\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.\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 cases. If another skin sensitisation test is used, justification must be provided.\nThe studies in column 1 do not need to be conducted if:\n- the available information indicates that the substance meets the criteria for classification for skin sensitisation or skin corrosion,\n- the substance is a strong acid (pH≤ 2.0) or base (pH≥ 11.5), or\n- the substance 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) of 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 substance.\nAn in vivo study for skin sensitisation must not be conducted unless the in vitro or in chemico test methods of OECD TG 497 are not applicable, or the results obtained from those studies are not adequate for classification and risk assessment.\nIn vivo skin sensitisation studies that were initiated before 6th October 2025 will be considered appropriate to address this information requirement.\n8.4.\nRespiratory sensitisation\nADS\n8.5. Mutagenicity\nThe assessment of this endpoint shall comprise the following consecutive steps:\nan assessment of the available in vivo genotoxicity data\nan in vitro test for gene mutations in bacteria, an in vitro cytogenicity test in mammalian cells and an in vitro gene mutation test in mammalian cells are required\nappropriate in vivo genotoxicity studies shall be considered in case of a positive result in any of the in vitro genotoxicity studies\n8.5.1.\nIn vitro gene mutation study in bacteria\n8.5.2.\nIn vitro cytogenicity study in mammalian cells\n8.5.3.\nIn vitro gene mutation study in mammalian cells\n8.6\nIn vivo genotoxicity study.\nThe assessment must comprise the following tiers:\n(a) if there is a positive result in any of the in vitro genotoxicity studies as listed in 8.5 and there are no reliable results available from an appropriate in vivo somatic cell genotoxicity study, an appropriate in vivo somatic cell genotoxicity study must be conducted;\n(b) a second in vivo somatic cell genotoxicity study may be necessary depending on the in vitro and in vivo results, type of effects, quality and relevance of all available data;\n(c) if there is a positive result from an in vivo somatic cell genotoxicity study available, the potential for germ cell mutagenicity should be considered based on all available data, including toxicokinetic evidence to demonstrate whether the substance has the capacity to reach germ cells. If no clear conclusions about germ cell mutagenicity can be made, additional investigations must be considered.\nADS\nThe studies in column 1 do not need to be conducted if:\n- the results are negative for the three in vitro tests listed in 8.5 and no other concern has been identified (e.g. metabolites of concern formed in mammals), or\n- the substance meets the criteria to be classified as a germ cell mutagen Category 1A or 1B.\nThe germ cell genotoxicity test does not need to be conducted if the substance meets the criteria to be classified as a carcinogen, Category 1A or 1B and a germ cell mutagen Category 2.\nWhere in vivo genotoxicity testing is required, repeated dose toxicity studies should be integrated with appropriate genotoxicity tests where possible.\n8.7.\nAcute toxicity\nIn addition to the oral route of administration (8.7.1), for substances other than gases, the information mentioned under 8.7.2 to 8.7.3 shall be provided for at least one other route of administration\nThe choice for the second route will depend on the nature of the substance and the likely route of human exposure\nGases and volatile liquids should be administered by the inhalation route\nIf the only route of exposure is the oral route, then information for only that route need be provided. If either the dermal or inhalation route is the only route of exposure to humans then an oral test may be considered. Before a new dermal acute toxicity study is carried out, an in vitro dermal penetration study (OECD 428) should be conducted to assess the likely magnitude and rate of dermal bioavailability\nThere may be exceptional circumstances where all routes of administration are deemed necessary\nThe study/ies do(es) not generally need to be conducted if:\nthe substance is classified as corrosive to the skin\n8.7.1.\nBy oral route\nThe Acute Toxic Class Method is the preferred method for the determination of this endpoint\nThe study need not be conducted if:\nthe substance is a gas or a highly volatile substance\n8.7.2.\nBy inhalation\nTesting by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account:\nthe vapour pressure of the substance (a volatile substance has vapour pressure > 1 × 10–2 Pa at 20 °C) and/or\nthe active substance is a powder containing a significant proportion (e.g. 1 % on a weight basis) of particles with particle size MMAD < 50 micrometers or\nthe active substance is included in products that are powders or are applied in a manner that generates exposure to aerosols, particles or droplets of an inhalable size (MMAD < 50 micrometers)\nthe Acute Toxic Class Method is the preferred method for the determination of this endpoint\n8.7.3.\nBy dermal route\nTesting by the dermal route is necessary only if:\ninhalation of the substance is unlikely, or\nskin contact in production and/or use is likely, and either\nthe physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin, or\nthe results of an in vitro dermal penetration study (OECD 428) demonstrate high dermal absorption and bioavailability\n8.8. Toxicokinetics and metabolism studies in mammals\nThe toxicokinetics and metabolism studies should provide basic data about the rate and extent of absorption, the tissue distribution and the relevant metabolic pathway including the degree of metabolism, the routes and rate of excretion and the relevant metabolites\n8.8.1.\nFurther toxicokinetic and metabolism studies in mammals\nAdditional studies might be required based on the outcome of the toxicokinetic and metabolism study conducted in rat. These further studies shall be required if:\nthere is evidence that metabolism in the rat is not relevant for human exposure\nroute-to-route extrapolation from oral to dermal/inhalation exposure is not feasible\nWhere it is considered appropriate to obtain information on dermal absorption, the assessment of this endpoint shall proceed using a tiered approach for assessment of dermal absorption\nADS\n8.9.\nRepeated dose toxicity\nIn general, only one route of administration is necessary and the oral route is the preferred route. However, in some cases it may be necessary to evaluate more than one route of exposure.\nFor the evaluation of the safety of consumers in relation to active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route\nTesting by the dermal route shall be considered if:\nskin contact in production and/or use is likely, and\ninhalation of the substance is unlikely, and\none of the following conditions is met:\n(i)toxicity is observed in an acute dermal toxicity test at lower doses than in the oral toxicity test, or\n(ii)information or test data indicate dermal absorption is comparable or higher than oral absorption, or\n(iii)dermal toxicity is recognised for structurally related substances and for example is observed at lower doses than in the oral toxicity test or dermal absorption is comparable or higher than oral absorption\nTesting by the inhalation route shall be considered if:\nexposure of humans via inhalation is likely taking into account the vapour pressure of the substance (volatile substances and gases have vapour pressure > 1 × 10–2 Pa at 20 °C), and/or\nthere is the possibility of exposure to aerosols, particles or droplets of an inhalable size (MMAD < 50 micrometers)\nThe repeated dose toxicity study (28 or 90 days) does not need to be conducted if:\na substance undergoes immediate disintegration and there are sufficient data on the cleavage products for systemic and local effects and no synergistic effects are expected, or\nrelevant human exposure can be excluded in accordance with Section 3 of Annex IV\nIn order to reduce testing carried out on vertebrates and in particular the need for free-standing single-endpoint studies, the design of the repeated dose toxicity studies shall take account of the possibility to explore several endpoints within the framework of one study\n8.9.1.\nShort-term repeated dose toxicity study (28 days), preferred species is rat\nThe short-term toxicity study (28 days) does not need to be conducted if:\n(i)a reliable sub-chronic (90 day) study is available, provided that the most appropriate species, dosage, solvent and route of administration were used,\n(ii)the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met:\nother available data indicate that the substance may have a dangerous property that cannot be detected in a short-term toxicity study, or\nappropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites in certain tissues or organs which would possibly remain undetected in a short term toxicity study but which are liable to result in adverse effects after prolonged exposure\n8.9.2.\nSub-chronic repeated dose toxicity study (90 days), preferred species is rat\nThe sub-chronic toxicity study (90 days) does not need to be conducted if:\na reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the criteria for classifying the substance as H372 and H373 (Regulation (EC) No 1272/2008), for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor allows the extrapolation towards the NOAEL-90 days for the same route of exposure, and\na reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used, or\nthe substance is unreactive, insoluble, not bioaccumulative and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day ‘limit test’, particularly if such a pattern is coupled with limited human exposure\n8.9.3.\nLong-term repeated dose toxicity (≥ 12 months)\nThe long-term toxicity study (≥ 12 months) does not need to be conducted if:\nLong-term exposure can be excluded and no effects have been seen at the limit dose in the 90-day study or\na combined long-term repeated dose/carcinogenicity study (8.11.1) is undertaken\n8.9.4.\nFurther repeat dose studies\nFurther repeat dose studies including testing on a second species (non-rodent), studies of longer duration or through a different route of administration shall be undertaken in case of:\nno other information on toxicity for a second non-rodent species is provided for, or\nfailure to identify a no observed adverse effect level (NOAEL) in the 28- or the 90-day study, unless the reason is that no effects have been observed at the limit dose, or\nsubstances bearing positive structural alerts for effects for which the rat or mouse is an inappropriate or insensitive model, or\ntoxicity of particular concern (e.g. serious/severe effects), or\nindications of an effect for which the available data is inadequate for toxicological and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity, hormonal activity), or\nconcern regarding local effects for which a risk characterisation cannot be performed by route-to route extrapolation, or\nparticular concern regarding exposure (e.g. use in biocidal products leading to exposure levels which are close to the toxicologically relevant dose levels), or\neffects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28- or the 90-day study, or\nthe route of administration used in the initial repeated dose study was inappropriate in relation to the expected route of human exposure and route-to-route extrapolation cannot be made.\nADS\n8.10\nReproductive toxicity.\nFor evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route.\nThe studies do not need to be conducted if:\n- the substance meets the criteria to be classified as a genotoxic carcinogen (classified both as germ cell mutagen Category 2, 1A or 1B and carcinogenic Category 1A or 1B), and appropriate risk management measures are implemented including measures related to reproductive toxicity,\n- the substance meets the criteria to be classified as a germ cell mutagen Category 1A or 1B and appropriate risk management measures are implemented including measures related to reproductive toxicity,\n- the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available provided that the dataset is sufficiently comprehensive and informative), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma or blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and the pattern of use indicates that there is no or negligible human or animal exposure,\n- the substance meets the criteria to be classified as reproductive toxicity Category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for sexual function and fertility will be necessary. A full justification must be provided and documented if investigations for developmental toxicity are not conducted, or\n- the substance is known to cause developmental toxicity, meeting the criteria for classification as reproductive toxicity Category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. A full justification must be provided and documented if investigations for sexual function and fertility are not conducted.\nNotwithstanding the provisions of this column of this row, studies on reproductive toxicity may need to be conducted to obtain information on endocrine disrupting properties as laid down in 8.13.3.1.\n8.10.1\nPrenatal Developmental Toxicity Study (OECD TG 414) on two species, preferred first species is rabbit (non-rodent) and preferred second species is rat (rodent); oral route of administration is the preferred route.\nThe study on the second species must not be conducted if the study performed on the first species or other available data indicate that the substance causes developmental toxicity meeting the criteria for classification as toxic for reproduction Category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment.\n8.10.2\nExtended One-Generation Reproductive Toxicity Study (OECD TG 443), with cohorts 1A and 1B and extension of cohort 1B to include the F2 generation with the aim to produce 20 litters per dose group, F2 pups must be followed to weaning and investigated similarly as F1 pups. Rat is the preferred species and oral route of administration is the preferred route.\nThe highest dose level should be based on toxicity and selected with the aim to induce reproductive or other systemic toxicity.\nA two-generation reproductive toxicity study conducted in accordance with OECD TG 416 (adopted 2001 or later) or equivalent information will be considered appropriate to address this information requirement, if the study is available and was initiated before 6th October 2025.\nWherever possible, the storage of organ samples (including serum samples) from any of the cohorts and generations of the extended one-generation reproductive toxicity study is highly recommended. These samples may be useful for follow-up investigations, without the need for further animal testing.\n8.10.3\nDevelopmental neurotoxicity.\nDevelopmental Neurotoxicity Study in accordance with OECD TG 426, or any relevant study (set) providing equivalent information, or cohorts 2A and 2B of an Extended One-Generation Reproductive Toxicity Study (OECD TG 443) with additional investigation for cognitive functions.\nADS\nThe study must not be conducted if the available data:\n- indicate that the substance causes developmental toxicity and meets the criteria to be classified as toxic for reproduction Category 1A or 1B: May damage the unborn child (H360D), and\n- are adequate to support a robust risk assessment.\nThe study must only be conducted if triggered by one of the following:\n- neurotoxicity occurs in adult animals,\n- the active substance interacts with molecules in the nervous system of the target organism, or\n- thyroid toxicity (including changes in thyroid hormones) occurs in adult animals.\n8.10.4\nFurther studies.\nA decision on the need to perform additional studies, including those providing information on the mechanisms, should be based on the outcomes of the studies listed in 8.10.1, 8.10.2, 8.10.3 and all other relevant available data.\nADS\nAny additional in vivo study must be scientifically justified.\n8.11.\nCarcinogenicity\nSee 8.11.1 for new study requirements\nA carcinogenicity study does not need to be conducted if:\nthe substance is classified as mutagen category 1A or 1B. The default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be required\n8.11.1.\nCombined carcinogenicity study and long-term repeated dose toxicity\nRat, oral route of administration is the preferred route. If an alternative route is proposed a justification must be provided.\nFor evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route\n8.11.2\nCarcinogenicity testing in a second species.\n(a) A second carcinogenicity study should be conducted using the mouse as test species.\n(b) For evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route.\nThe second carcinogenicity study does not need to be conducted if the applicant can justify on the basis of scientific grounds that it is not necessary.\n8.12. Relevant health data, observations and treatments\nJustification should be provided if data is not available\n8.12.1\nInformation on signs of poisoning, clinical tests, first aid measures, antidotes, medical treatment and prognosis following poisoning.\n8.12.2\nEpidemiological studies.\n8.12.3\nMedical surveillance data, health records and case reports.\n8.13.\nAdditional studies\nAdditional data which may be required depending on the characteristics and intended use of the active substance\nOther available data: Available data from emerging methods and models, including toxicity pathway-based risk assessment, in vitro and ‘omic’ (genomic, proteomic, metabolomic, etc.) studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening shall be submitted in parallel\nADS\n8.13.1.\nPhototoxicity\nADS\n8.13.2\nNeurotoxicity.\nIf the active substance is an organophosphorus compound or if there is an indication, knowledge of the mechanism of action or knowledge from acute or repeated dose studies that the active substance may have neurotoxic properties, additional information or specific studies (such as OECD TG 424 or OECD TG 418 or OECD TG 419 or equivalent) will be required.\nIf anticholinesterase activity is detected, a test for response to reactivating agents should be considered.\nFor evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route.\nADS\n8.13.3\nEndocrine disruption.\nThe assessment of endocrine disruption must comprise the following tiers:\n(a) an assessment of the available information from the following studies, where available, and any other relevant information, including in vitro and in silico methods:\n(i) 8.9.1 a 28-day oral toxicity study in rodents (OECD TG 407);\n(ii) 8.9.2 a 90-day oral toxicity study in rodents (OECD TG 408);\n(iii) 8.9.4 a repeated dose oral toxicity study in non-rodents (OECD TG 409);\n(iv) 8.10.1 a prenatal developmental toxicity study (OECD TG 414);\n(v) 8.10.2 an extended one-generation reproductive toxicity study (OECD TG 443) or two-generation reproductive toxicity study (OECD TG 416);\n(vi) 8.10.3 a developmental neurotoxicity study (OECD TG 426);\n(vii) 8.11.1 a combined carcinogenicity study and long-term repeated dose toxicity study (OECD TG 451-3);\n(viii) a systematic review of the literature including studies on mammals and non-mammalian organisms.\n(b) If there is any information suggesting that the active substance may have endocrine disrupting properties, or if there is incomplete information on key parameters relevant for concluding on endocrine disruption, then additional information or specific studies must be provided which elucidate one or more of the following, as appropriate:\n(i) the mode or the mechanism of action;\n(ii) potentially relevant adverse effects in humans or animals.\nFor evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to consider the oral route and conduct animal studies by the oral route.\nWhere sufficient weight of evidence to conclude on the presence or absence of a particular endocrine disrupting mode of action is available:\n- further testing on vertebrate animals for that effect must be omitted for that mode of action;\n- further testing not involving vertebrate animals may be omitted for that mode of action.\nIn all cases, adequate and reliable documentation must be provided.\n8.13.3.1\nSpecific additional studies to investigate potential endocrine disrupting properties may include, but are not limited to, the following:\n(a) the mammalian toxicity studies listed in 8.13.3(a);\n(b) the in vitro assays:\n(i) estrogen receptor transactivation assay (OECD TG 455);\n(ii) androgen receptor transactivation assay, (OECD TG 458);\n(iii) H295R steroidogenesis assay (OECD TG 456);\n(iv) the aromatase assay (human recombinant) OPPTS 890.1200;\n(c) uterotrophic bioassay in rodents (OECD TG 440) and Hershberger bioassay in rats (OECD TG 441);\n(d) pubertal development and thyroid function in intact juvenile or peripubertal male rats (OPPTS 890.1500).\nThe decision to carry out studies in mammals must be taken based on all available information, including a systematic review of the literature (including information on endocrine disrupting effects in non-target organisms) and the availability of suitable in silico or in vitro methods.\nADS\n8.13.4\nImmunotoxicity and developmental immunotoxicity.\nIf there is any evidence from repeat dose or reproductive toxicity studies that the active substance may have immunotoxic properties, additional information or specific studies must be provided which elucidate one or more of the following, as appropriate:\n(i) the mode or the mechanism of action;\n(ii) potentially relevant adverse effects in humans or animals.\nFor evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to consider the oral route and conduct animal studies by the oral route.\nADS\n8.13.5\nFurther mechanistic studies.\nA decision on the need to perform additional studies should be based on all relevant data.\nADS\n8.14.\nStudies related to the exposure of humans to the active substance\nADS\n8.15.\nToxic effects on livestock and pets\nADS\n8.16.\nFood and feeding stuffs studies including for food-producing animals and their products (milk, eggs and honey)\nAdditional information related to the exposure of humans to the active substance contained in biocidal products\nADS\n8.16.1.\nProposed acceptable residue levels i.e. maximum residue limits (MRL) and the justification of their acceptability\nADS\n8.16.2.\nBehaviour of the residue of the active substance on the treated or contaminated food or feeding stuffs including the kinetics of disappearance\nResidue definitions should be provided where relevant. It is also important to compare residues found in toxicity studies with residues formed in food-producing animals and their products, as well as food and feed\nADS\n8.16.3.\nOverall material balance for the active substance\nSufficient residue data from supervised trials on food- producing animals and their products, as well as food and feed, to demonstrate that residues likely to arise from the proposed use would not be of concern for human or animal health\nADS\n8.16.4.\nEstimation of potential or actual exposure of humans to the active substance and residues through diet and other means\nADS\n8.16.5.\nIf residues of the active substance occur in or on feeding stuffs for a significant period of time or are found in food of animal origin after treatment on or around food-producing animals (e.g. direct treatment on animals or indirect treatment of animal houses or surroundings) then feeding and metabolism studies in livestock shall be required to permit evaluation of residues in food of animal origin\nADS\n8.16.6.\nEffects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the active substance\nADS\n8.16.7.\nAny other available information that is relevant\nIt may be appropriate to include information on migration into food, especially in the case of treatment of food contact materials\nADS\n8.16.8.\nSummary and evaluation of data submitted under 8.16.1 to 8.16.8\nIt is important to establish whether the metabolites found in food (from animals or plants) are the same as those tested in toxicity studies. Otherwise values for risk assessment (e.g. ADI) are not valid for the residues found\nADS\n8.17.\nIf the active substance is to be used in products for action against plants including algae then tests shall be required to assess toxic effects of metabolites from treated plants, if any, where different from those identified in animals\nADS\n8.18.\n...\n9. ECOTOXICOLOGICAL STUDIES\n9.1. Toxicity to Aquatic Organisms\n9.1.1\nShort-term toxicity testing on fish.\nWhen short-term fish toxicity data is required, the threshold approach (tiered strategy) should be applied.\nLong-term toxicity testing on fish in accordance with point 9.1.6.1. will be considered if the substance is poorly water soluble, i.e. below 1 mg/l.\nThe study does not need to be conducted if:\n- a valid long-term aquatic toxicity study on fish is available;\n- sufficient weight of evidence including the use of other data such as the Fish Embryo Acute Toxicity (FET, OECD TG 236) or results obtained from non-animal methods is available for this data requirement.\n9.1.2. Short-term toxicity testing on aquatic invertebrates\n9.1.2.1.\nDaphnia magna\n9.1.2.2.\nOther species\nADS\n9.1.3. Growth inhibition study on algae\n9.1.3.1.\nEffects on growth rate of green algae\n9.1.3.2.\nEffects on growth rate of cyanobacteria or diatoms\n9.1.4.\nBioconcentration\nThe experimental determination may not need to be carried out if:\nit can be demonstrated on the basis of physico-chemical properties (e.g. log Kow < 3) or other evidence that the substance has a low potential for bioconcentration\n9.1.4.1.\nEstimation methods\n9.1.4.2.\nExperimental determination\n9.1.5.\nInhibition of microbial activity\nThe study may be replaced by a nitrification inhibition test if available data show that the substance is likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria\n9.1.6.\nFurther Toxicity Studies on Aquatic Organisms\nIf the results of the ecotoxicological studies, studies on fate and behaviour and/or the intended use(s) of the active substance indicate a risk for the aquatic environment, or if long-term exposure is expected, then one or more of the tests described in this Section shall be conducted\nADS\n9.1.6.1\nLong term toxicity testing on fish.\nThe information must be provided from long-term toxicity testing on fish in which early life-stages (eggs, larvae or juveniles) are exposed.\nADS\n9.1.6.2.\nLong term toxicity testing on invertebrates\n(a)Daphnia growth and reproduction study\n(b)Other species reproduction and growth (e.g. Mysid)\n(c)Other species development and emergence (e.g. Chironomus)\nADS\n9.1.7.\nBioaccumulation in an appropriate aquatic species\nADS\n9.1.8.\nEffects on any other specific, non-target organisms (flora and fauna) believed to be at risk\nADS\n9.1.9.\nStudies on sediment- dwelling organisms\nADS\n9.1.10.\nEffects on aquatic macrophytes\nADS\n9.2.\nTerrestrial toxicity, initial tests\nADS\n9.2.1.\nEffects on soil micro-organisms\n9.2.2.\nEffects on earthworms or other soil- dwelling non-target invertebrates\n9.2.3.\nAcute toxicity to plants\n9.3.\nTerrestrial tests, long term\nADS\n9.3.1.\nReproduction study with earthworms or other soil-dwelling non-target invertebrates\n9.4.\nEffects on birds\nADS\nFor endpoint 9.4.3 the study does not need to be conducted if:\nthe dietary toxicity study shows that the LC50 is above 2 000 mg/kg\n9.4.1.\nAcute oral toxicity\n9.4.2.\nShort-term toxicity — eight-day dietary study in at least one species (other than chickens, ducks and geese)\n9.4.3.\nEffects on reproduction\n9.5.\nEffects on arthropods\nADS\n9.5.1.\nEffects on honeybees\n9.5.2.\nOther non-target terrestrial arthropods, e.g. predators\n9.6.\nBioconcentration, terrestrial\nADS\n9.7.\nBioaccumulation, terrestrial\nADS\n9.8.\nEffects on other non-target, non-aquatic organisms\nADS\n9.9.\nEffects on mammals\nADS\nData are derived from the mammalian toxicological assessment. The most sensitive relevant mammalian long-term toxicological endpoint (NOAEL) expressed as mg test compound/kg bw/day shall be reported\n9.9.1.\nAcute oral toxicity\n9.9.2.\nShort term toxicity\n9.9.3.\nLong term toxicity\n9.9.4.\nEffects on reproduction\n9.10\nEndocrine disruption.\nThe assessment of endocrine disruption properties must comprise the following tiers:\n(a) an assessment of the mammalian data set in accordance with 8.13.3 to assess whether the substance has endocrine disrupting properties based on data in relation to mammals;\n(b) if it cannot be concluded based on the mammalian data in accordance with 8.13.3 or 9.1.6.1 that the substance has endocrine disrupting properties, the studies set out in 9.10.1 or 9.10.2 will be considered taking account of any other available relevant information, including a systematic review of the literature.\n9.10.1\nEndocrine disruption in fish.\nSpecific studies to investigate potential endocrine disrupting properties may include, but are not limited to, the following data requirements:\n(a) Medaka Extended One-Generation Reproduction Test (MEOGRT, OECD TG 240);\n(b) Fish life cycle toxicity test (FLCTT, OPPTS 850.1500) covering all the ‘estrogen-, androgen- and steroidogenic-mediated’ (EAS) parameters foreseen to be measured in the MEOGRT study.\nThe study does not need to be carried out if:\n- there is no indication for endocrine activity or endocrine related effects from a sufficient mammalian data set in accordance with 8.13.3 or from any other relevant information (e.g. literature), and\n- valid in vivo data is available, with no information suggesting that the active substance may elicit endocrine activity or effects potentially related to endocrine activity in either the Fish Short Term Reproduction Assay (FSTRA; OECD TG 229), or the 21-days Fish Assay (OECD TG 230) or Fish Sexual Developmental Test (FSDT, OECD TG 234).\nIf other data are available covering the estrogenic, androgenic and steroidogenic, (EAS) related modalities or parameters investigated in OECD TG 229 or OECD TG 230 or OECD TG 234, those data can be used instead.\n9.10.2\nEndocrine disruption in amphibians.\nSpecific additional studies to investigate potential endocrine disrupting properties may include, but are not limited to Larval Amphibian Growth and Development Assay (LAGDA; OECD TG 241).\nThe study does not need to be carried out if:\n- there is no indication for endocrine activity or endocrine related effects from a sufficient mammalian data set in accordance with 8.13.3 or from any other relevant information (e.g. literature), and\n- valid in vivo data is available, with no information suggesting that the active substance may have endocrine disrupting properties in an Amphibian Metamorphosis Assay (AMA; OECD 231).\n9.10.3\nIf there is information suggesting that the active substance may have endocrine disrupting properties, or if there is incomplete information on key parameters relevant for concluding on endocrine disruption, additional information or specific studies, as necessary, must be provided which elucidate one or more of the following:\n(a) the mode or the mechanism of action;\n(b) potentially relevant adverse effects in humans or animals.\nADS\n10. ENVIRONMENTAL FATE AND BEHAVIOUR\n10.1. Fate and behaviour in water and sediment\n10.1.1. Degradation, initial studies\nIf the assessment performed indicates the need to investigate further the degradation of the substance and its degradation products or the active substance has an overall low or absent abiotic degradation, then the tests described in 10.1.3 and 10.3.2 and where appropriate — in 10.4 shall be required. The choice of the appropriate test(s) depends on the results of the initial assessment performed\n10.1.1.1.\nAbiotic\n(a)\nHydrolysis as a function of pH and identification of breakdown products\nThe identification of breakdown products is required when the breakdown products at any sampling time are present at ≥ 10 %\n(b)\nPhototransformation in water, including identification of transformation products\n10.1.1.2.\nBiotic\n(a)\nReady biodegradability\n(b)\nInherent biodegradability (where appropriate)\n10.1.2.\nAdsorption/desorption\n10.1.3. Rate and route of degradation including identification of metabolites and degradation products\n10.1.3.1.\nBiological sewage treatment\n(a)\nAerobic biodegradation\nADS\n(b)\nAnaerobic biodegradation\nADS\n(c)\nSTP simulation test\nADS\n10.1.3.2.\nBiodegradation in freshwater\n(a)\nAerobic aquatic degradation study\nADS\n(b)\nWater/sediment degradation test\nADS\n10.1.3.3.\nBiodegradation in sea water\nADS\n10.1.3.4.\nBiodegradation during manure storage\nADS\n10.1.4.\nAdsorption and desorption in water/aquatic sediment systems and, where relevant, adsorption and desorption of metabolites and degradation products\nADS\n10.1.5.\nField study on accumulation in sediment\nADS\n10.1.6.\nInorganic substances: information on fate and behaviour in water\nADS\n10.2.\nFate and behaviour in soil\nADS\n10.2.1.\nLaboratory study on rate and route of degradation including identification of the processes involved and identification of any metabolites and degradation products in one soil type (unless pH dependent route) under appropriate conditions\nLaboratory studies on rate of degradation in three additional soil types\nADS\n10.2.2.\nField studies, two soil types\nADS\n10.2.3.\nSoil accumulation studies\nADS\n10.2.4.\nAdsorption and desorption in at least three soil types and, where relevant, adsorption and desorption of metabolites and degradation products\nADS\n10.2.5.\nFurther studies on sorption\n10.2.6.\nMobility in at least three soil types and where relevant mobility of metabolites and degradation products\nADS\n10.2.6.1.\nColumn leaching studies\n10.2.6.2.\nLysimeter studies\n10.2.6.3.\nField leaching studies\n10.2.7.\nExtent and nature of bound residues\nThe determination and characteristics of bound residues is recommended to be combined with a soil simulation study\nADS\n10.2.8.\nOther soil degradation studies\nADS\n10.2.9.\nInorganic substances: information on fate and behaviour in soil\n10.3. Fate and behaviour in air\n10.3.1.\nPhototransformation in air (estimation method)\nIdentification of transformation products\n10.3.2.\nFate and behaviour in air, further studies\nADS\n10.4.\nAdditional studies on fate and behaviour in the environment\nADS\n10.5.\nDefinition of the residue\nADS\n10.5.1.\nDefinition of the residue for risk assessment\n10.5.2.\nDefinition of the residue for monitoring\n10.6.\nMonitoring data\nADS\n10.6.1.\nIdentification of all degradation products (> 10 %) must be included in the studies on degradation in soil, water and sediments\n11. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT\n11.1.\nRecommended methods and precautions concerning handling, use, storage, transport or fire\n11.2.\nIn case of fire, nature of reaction products, combustion gases etc.\n11.3.\nEmergency measures in case of accident\n11.4.\nPossibility of destruction or decontamination following release in or on the following:\n(a)air\n(b)water, including drinking water\n(c)soil\n11.5.\nProcedures for waste management of the active substance for industry or professional users\n11.6.\nPossibility of reuse or recycling\n11.7.\nPossibility of neutralisation of effects\n11.8.\nConditions for controlled discharge including leachate qualities on disposal\n11.9.\nConditions for controlled incineration\n11.10.\nIdentification of any substances falling within the scope of List I or List II of the Annex to Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances, of Annexes I and II to Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration, of Annex I to Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, of Part B of Annex I to Directive 98/83/EC or Annexes VIII and X to Directive 2000/60/EC\n12. CLASSIFICATION, LABELLING AND PACKAGING\n12.1.\nState any existing classification and labelling\n12.2. The hazard classification of the substance resulting from the application of Regulation (EC) No 1272/2008\nIn addition, for each entry, the reasons why no classification is given for an endpoint should be provided\n12.2.1.\nHazard classification\n12.2.2.\nHazard pictogram\n12.2.3.\nSignal word\n12.2.4.\nHazard statements\n12.2.5.\nPrecautionary statements including prevention, response, storage and disposal\n12.3.\nSpecific concentration limits, where applicable, resulting from the application of Regulation (EC) No 1272/2008\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 2 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. 1 para. 1(4)(a) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Annex 2 Title 1 table row 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(4)(b) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Annex 2 Title 1 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(4)(c) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Annex 2 Title 1 table row 2.8 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. 1 para. 1(4)(d) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Annex 2 Title 1 table row 2.11.1 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(4)(e) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Annex 2 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. 1 para. 1(4)(f) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Annex 2 Title 1 table row 6.7.2 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(4)(g) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Annex 2 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. 1 para. 1(4)(h) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Annex 2 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. 1 para. 1(4)(i) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Annex 2 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. 1 para. 1(4)(j) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F11",
      "text": "Annex 2 Title 1 table row 8.6 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. 1 para. 1(4)(k) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F12",
      "text": "Annex 2 Title 1 table row 8.10 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(4)(l) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F13",
      "text": "Annex 2 Title 1 table row 8.10.1 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(4)(m) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F14",
      "text": "Annex 2 Title 1 table row 8.10.2 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(4)(n) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F15",
      "text": "Annex 2 Title 1 table row 8.10.3 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. 1 para. 1(4)(o) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F16",
      "text": "Annex 2 Title 1 table row 8.10.4 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(4)(p) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F17",
      "text": "Annex 2 Title 1 table row 8.11.2 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(4)(q) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F18",
      "text": "Annex 2 Title 1 table rows 8.12.1-8.12.3 substituted for rows 8.12.1-8.12.8 (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(4)(r) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F19",
      "text": "Annex 2 Title 1 table row 8.13.2 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(4)(s) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F20",
      "text": "Annex 2 Title 1 table row 8.13.3 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. 1 para. 1(4)(t) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F21",
      "text": "Annex 2 Title 1 table row 8.13.3.1 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(4)(u) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F22",
      "text": "Annex 2 Title 1 table row 8.13.4 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(4)(v) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F23",
      "text": "Annex 2 Title 1 table row 8.13.5 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(4)(w) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F24",
      "text": "Annex 2 Title 1 table row 8.18 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(4)(x) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F25",
      "text": "Annex 2 Title 1 table row 9.1.1 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(4)(y) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F26",
      "text": "Annex 2 Title 1 table row 9.1.6.1 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(4)(z) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F27",
      "text": "Annex 2 Title 1 table row 9.10 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(4)(z1) (with reg. 3)"
    },
    {
      "type": "F",
      "label": "F28",
      "text": "Annex 2 Title 1 table rows 9.10.1-9.10.3 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(4)(z2) (with reg. 3)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "The information provided should be for the purified active substance of stated specification or for the active substance as manufactured, if different."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "The information provided should be for the purified active substance of stated specification."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ L 20, 26.1.1980, p. 43."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ L 372, 27.12.2006, p. 19."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "OJ L 348, 24.12.2008, p. 84."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2012/528/annex/II/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."
}