Column 1
Information required
| Column 2
All data is CDS unless indicated as ADS
| Column 3
Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates
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1.
APPLICANT
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| 1.3. | Active substance manufacturer (name, address and location of manufacturing plant(s)) |
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2.
IDENTITY OF THE ACTIVE SUBSTANCE
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| For the active substance, the information given in this Section shall 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 information on one or more of the items below, the reasons shall be clearly stated | | |
| 2.1. | Common name proposed or accepted by ISO and synonyms (usual name, trade name, abbreviation) |
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| 2.2. | Chemical name (IUPAC and CA nomenclature or other international chemical name(s)) |
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| 2.3. | Manufacturer’s development code number(s) |
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| 2.4. | CAS number plus EC, INDEX and CIPAC numbers |
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| 2.5. | Molecular and structural formula (including SMILES notation, if available and appropriate) |
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| 2.6. | Information on optical activity and full details of any isomeric composition (if applicable and appropriate) |
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| 2.8. | Method of manufacture (syntheses pathway) of active substance including information on starting materials and solvents including suppliers, specifications and commercial availability |
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| 2.9. | Specification 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 |
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| 2.10. | The 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 |
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| 2.11. | Analytical profile of at least five representative batches (g/kg active substance) including information on content of the impurities referred to in 2.10. |
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| 2.12. | The origin of the natural active substance or the precursor(s) of the active substance, e.g. an extract of a flower |
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3.
PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE
|
3.1.
Appearance (4)
|
| 3.1.1. | Aggregate state (at 20 °C and 101,3 kPa) |
| | |
| 3.1.2. | Physical state (i.e. viscous, crystalline, powder) (at 20 °C and 101,3 kPa) |
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| 3.1.3. | Colour (at 20 °C and 101,3 kPa) |
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| 3.1.4. | Odour (at 20 °C and 101,3 kPa) |
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| 3.2. | Melting/freezing point (5) |
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| 3.6. | Absorption spectra data (UV/VIS, IR, NMR) and a mass spectrum, molar extinction coefficient at relevant wavelengths, where relevant (5) |
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3.7.
Vapour pressure (5)
|
| 3.7.1. | Henry’s law constant must always be stated for solids and liquids if it can be calculated |
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| 3.10. | Partition coefficient (n-octanol/water) and its pH dependency (5) |
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| 3.11. | Thermal stability, identity of breakdown products (5) |
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| 3.12. | Reactivity towards container material |
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| 3.13. | Dissociation constant |
| ADS | |
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| ADS | |
| 3.16. | Solubility in organic solvents, including effect of temperature on solubility (5) |
| ADS | |
| 3.17. | Stability in organic solvents used in biocidal products and identity of relevant breakdown products (4) |
| ADS | |
4.
PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS
|
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| 4.8. | Self-reactive substances and mixtures |
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| 4.11. | Self-heating substances and mixtures |
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| 4.12. | Substances and mixtures which in contact with water emit flammable gases |
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4.17.
Additional physical indicators for hazards
|
| 4.17.1. | Auto-ignition temperature (liquids and gases) |
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| 4.17.2. | Relative self ignition temperature for solids |
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| 4.17.3. | Dust explosion hazard |
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5.
METHODS OF DETECTION AND IDENTIFICATION
|
| 5.1. | Analytical 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)
For impurities other than relevant impurities this only applies if they are present at ≥ 1 g/kg
|
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5.2.
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
|
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| 5.2.3. | Water (surface, drinking etc.) and sediment |
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| 5.2.4. | Animal and human body fluids and tissues |
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| 5.3. | Analytical 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 otherproducts 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) |
| ADS | |
6.
EFFECTIVENESS AGAINST TARGET ORGANISMS
|
| 6.1. | Function, e.g. fungicide, rodenticide, insecticide, bactericide and mode of control e.g. attracting, killing, inhibiting |
| | |
| 6.2. | Representative organism(s) to be controlled and products, organisms or objects to be protected |
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| 6.3. | Effects on representative target organism(s) |
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| 6.4. | Likely concentration at which the active substance will be used in products and, where appropriate, in treated articles |
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| 6.5. | Mode of action (including time delay) |
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| 6.6. | Efficacy data to support these claims on biocidal products and, where label claims are made, on treated articles, including any available standard protocols, laboratory tests or field trials used including performance standards where appropriate |
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6.7.
Any known limitations on efficacy
|
| 6.7.1. | Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies |
| | |
| 6.7.2. | Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms |
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7.
INTENDED USES AND EXPOSURE
|
| 7.1. | Field of use(s) envisaged for biocidal products and, where appropriate, treated articles |
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| 7.3. | Detailed description of the intended use pattern(s) including in treated articles |
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| 7.4. | Users e.g. industrial, trained professional, professional or general public (non-professional) |
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| 7.5. | Likely tonnage to be placed on the market per year and, where relevant, for the envisaged major use categories |
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7.6.
Exposure data in conformity with Annex VI to this Regulation
|
| 7.6.1. | Information on human exposure associated with the intended uses and disposal of the active substance |
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| 7.6.2. | Information on environmental exposure associated with the intended uses and disposal of the active substance |
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| 7.6.3. | Information on exposure of food- producing animals and food and feeding stuffs associated with the intended uses of the active substance |
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| 7.6.4. | Information on exposure from treated articles including leaching data (either laboratory studies or model data) |
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8.
TOXICOLOGICAL PROFILE FOR HUMAN AND ANIMAL INCLUDING METABOLISM
|
| 8.1. | Skin irritation or skin corrosion
The assessment of this endpoint shall be carried out according to the sequential testing strategy for dermal irritation and corrosion set out in the Appendix to Test Guideline B.4. Acute Toxicity-Dermal Irritation/Corrosion (Annex B.4. to Regulation (EC) No 440/2008)
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| 8.2. | Eye irritation
The assessment of this endpoint shall be carried out according to the sequential testing strategy for eye irritation and corrosion as set down in the Appendix to Test Guideline B.5.Acute Toxicity: Eye Irritation/Corrosion (Annex B.5. to Regulation (EC) No 440/2008)
|
| | |
| 8.3. | Skin sensitisation
The assessment of this endpoint shall comprise the following consecutive steps:
| 1. | an assessment of the available human, animal and alternative data |
| 2. | in vivo testing
The Murine Local Lymph Node Assay (LLNA) including, where appropriate, the reduced variant of the assay, is the first-choice method for in vivo testing. If another skin sensitisation test is used justification shall be provided
|
|
| | Step 2 does not need to be conducted if:
| — | the available information indicates that the substance should be classified for skin sensitisation or corrosivity, or |
| — | the substance is a strong acid (pH < 2,0) or base (pH > 11,5) |
|
| 8.4. | Respiratory sensitisation |
| ADS | |
8.5.
Mutagenicity
|
The assessment of this endpoint shall comprise the following consecutive steps:
| — | an assessment of the available in vivo genotoxicity data |
| — | an 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 |
| — | appropriate in vivo genotoxicity studies shall be considered in case of a positive result in any of the in vitro genotoxicity studies |
| | |
| 8.5.1. | In vitro gene mutation study in bacteria |
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| 8.5.2. | In vitro cytogenicity study in mammalian cells |
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| 8.5.3. | In vitro gene mutation study in mammalian cells |
| | |
| 8.6. | In vivo genotoxicity study
The assessment of this endpoint shall comprise the following consecutive steps:
| — | If there is a positive result in any of the in vitro genotoxicity studies and there are no results available from an in vivo study already, an appropriate in vivo somatic cell genotoxicity study shall be proposed/conducted by the applicant |
| — | If either of the in vitro gene mutation tests is positive, an in vivo test to investigate unscheduled DNA synthesis shall be conducted |
| — | A second in vivo somatic cell test may be necessary, depending on the results, quality and relevance of all the available data |
| — | If there is a positive result from an in vivo somatic cell study available, the potential for germ cell mutagenicity should be considered on the basis of all available data, including toxicokinetic evidence to demonstrate that the substance reached the tested organ. If no clear conclusions about germ cell mutagenicity can be made, additional investigations shall be considered |
|
| ADS | The study/ies do(es) not generally need to be conducted if:
| — | the results are negative for the three in vitro tests and if no metabolites of concern are formed in mammals or |
| — | valid in vivo micronucleus data is generated within a repeat dose study and the in vivo micronucleus test is the appropriate test to be conducted to address this information requirement |
| — | the substance is known to be carcinogenic category 1A or 1B or mutagenic category 1A, 1B or 2. |
|
| 8.7. | Acute toxicity
In 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
| — | The choice for the second route will depend on the nature of the substance and the likely route of human exposure |
| — | Gases and volatile liquids should be administered by the inhalation route |
| — | If 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 |
| — | There may be exceptional circumstances where all routes of administration are deemed necessary |
|
| | The study/ies do(es) not generally need to be conducted if:
| — | the substance is classified as corrosive to the skin |
|
| 8.7.1. | By oral route
The Acute Toxic Class Method is the preferred method for the determination of this endpoint
|
| | The study need not be conducted if:
| — | the substance is a gas or a highly volatile substance |
|
| 8.7.2. | By inhalation
Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account:
| — | the vapour pressure of the substance (a volatile substance has vapour pressure > 1 × 10–2 Pa at 20 °C) and/or |
| — | the 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 |
| — | the 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) |
| — | the Acute Toxic Class Method is the preferred method for the determination of this endpoint |
|
| | |
| 8.7.3. | By dermal route
Testing by the dermal route is necessary only if:
| — | inhalation of the substance is unlikely, or |
| — | skin contact in production and/or use is likely, and either |
| — | the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin, or |
| — | the results of an in vitro dermal penetration study (OECD 428) demonstrate high dermal absorption and bioavailability |
|
| | |
8.8.
Toxicokinetics and metabolism studies in mammals
|
| The 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 | | |
| 8.8.1. | Further toxicokinetic and metabolism studies in mammals
Additional studies might be required based on the outcome of the toxicokinetic and metabolism study conducted in rat. These further studies shall be required if:
| — | there is evidence that metabolism in the rat is not relevant for human exposure |
| — | route-to-route extrapolation from oral to dermal/inhalation exposure is not feasible |
Where 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
|
| ADS | |
| 8.9. | Repeated dose toxicity
In 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.
For 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
Testing by the dermal route shall be considered if:
| — | skin contact in production and/or use is likely, and |
| — | inhalation of the substance is unlikely, and |
| — | one of the following conditions is met:
| (i) | toxicity is observed in an acute dermal toxicity test at lower doses than in the oral toxicity test, or |
| (ii) | information or test data indicate dermal absorption is comparable or higher than oral absorption, or |
| (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 |
|
Testing by the inhalation route shall be considered if:
| — | exposure 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 |
| — | there is the possibility of exposure to aerosols, particles or droplets of an inhalable size (MMAD < 50 micrometers) |
|
| | The repeated dose toxicity study (28 or 90 days) does not need to be conducted if:
| — | a 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 |
| — | relevant human exposure can be excluded in accordance with Section 3 of Annex IV |
In 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
|
| 8.9.1. | Short-term repeated dose toxicity study (28 days), preferred species is rat |
| | The short-term toxicity study (28 days) does not need to be conducted if:
| (i) | a reliable sub-chronic (90 day) study is available, provided that the most appropriate species, dosage, solvent and route of administration were used, |
| (ii) | the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met:
| — | other available data indicate that the substance may have a dangerous property that cannot be detected in a short-term toxicity study, or |
| — | appropriately 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 |
|
|
| 8.9.2. | Sub-chronic repeated dose toxicity study (90 days), preferred species is rat |
| | The sub-chronic toxicity study (90 days) does not need to be conducted if:
| — | a 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 |
| — | a reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used, or |
| — | the 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 |
|
| 8.9.3. | Long-term repeated dose toxicity (≥ 12 months) |
| | The long-term toxicity study (≥ 12 months) does not need to be conducted if:
| — | Long-term exposure can be excluded and no effects have been seen at the limit dose in the 90-day study or |
| — | a combined long-term repeated dose/carcinogenicity study (8.11.1) is undertaken |
|
| 8.9.4. | Further repeat dose studies
Further 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:
| — | no other information on toxicity for a second non-rodent species is provided for, or |
| — | failure 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 |
| — | substances bearing positive structural alerts for effects for which the rat or mouse is an inappropriate or insensitive model, or |
| — | toxicity of particular concern (e.g. serious/severe effects), or |
| — | indications 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 |
| — | concern regarding local effects for which a risk characterisation cannot be performed by route-to route extrapolation, or |
| — | particular concern regarding exposure (e.g. use in biocidal products leading to exposure levels which are close to the toxicologically relevant dose levels), or |
| — | effects 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 |
| — | the 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. |
|
| ADS | |
| 8.10. | Reproductive toxicity
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
|
| | The studies need not be conducted if:
| — | the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented including measures related to reproductive toxicity, or |
| — | the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented including measures related to reproductive toxicity, or |
| — | 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/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 there is no or no significant human exposure |
| — | If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as Reproductive toxicity Cat 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered |
| — | If a substance is known to cause developmental toxicity, meeting the criteria for classification as Reproductive toxicity Cat 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. However, testing for effects on fertility must be considered |
|
| 8.10.1. | Pre-natal developmental toxicity study, preferred species is rabbit; oral route of administration is the preferred route.
The study shall be initially performed on one species
|
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| 8.10.2. | Two-generation reproductive toxicity study, rat, oral route of administration is the preferred route.
If another reproductive toxicity test is used justification shall be provided. The extended one-generation reproductive toxicity study adopted at OECD level shall be considered as an alternative approach to the multi-generation study
|
| | |
| 8.10.3. | Further pre-natal developmental toxicity study. A decision on the need to perform additional studies on a second species or mechanistic studies should be based on the outcome of the first test (8.10.1) and all other relevant available data (in particular rodent reprotox studies). Preferred species is rat, oral route of administration |
| ADS | |
| 8.11. | Carcinogenicity
See 8.11.1 for new study requirements
|
| | A carcinogenicity study does not need to be conducted if:
| — | the 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 |
|
| 8.11.1. | Combined carcinogenicity study and long-term repeated dose toxicity
Rat, oral route of administration is the preferred route. If an alternative route is proposed a justification must be provided.
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
|
| | |
| 8.11.2. | Carcinogenicity testing in a second species
| — | A second carcinogenicity study should normally be conducted using the mouse as test species |
| — | 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 |
|
| | |
8.12.
Relevant health data, observations and treatments
|
| Justification should be provided if data is not available | | |
| 8.12.1. | Medical surveillance data on manufacturing plant personnel |
| | |
| 8.12.2. | Direct observation, e.g. clinical cases, poisoning incidents |
| | |
| 8.12.3. | Health records, both from industry and any other available sources |
| | |
| 8.12.4. | Epidemiological studies on the general population |
| | |
| 8.12.5. | Diagnosis of poisoning including specific signs of poisoning and clinical tests |
| | |
| 8.12.6. | Sensitisation/allergenicity observations |
| | |
| 8.12.7. | Specific treatment in case of an accident or poisoning: first aid measures, antidotes and medical treatment, if known |
| | |
| 8.12.8. | Prognosis following poisoning |
| | |
| 8.13. | Additional studies
Additional data which may be required depending on the characteristics and intended use of the active substance
Other 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
|
| ADS | |
| ADS | |
| 8.13.2. | Neurotoxicity including developmental neurotoxicity
| — | The preferred test species is the rat unless another test species is justified to be more appropriate |
| — | For delayed neurotoxicity tests the preferred species will be the adult hen |
| — | If anticholinesterase activity is detected a test for response to reactivating agents should be considered |
If the active substance is an organophosphorus compound or if there is any evidence e.g. knowledge of the mechanism of action or from repeat dose studies that the active substance may have neurotoxic or developmental neurotoxic properties then additional information or specific studies will be required.
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
|
| ADS | |
| 8.13.3. | Endocrine disruption
If there is any evidence from in vitro, repeat dose or reproduction toxicity studies, that the active substance may have endocrine disrupting properties then additional information or specific studies shall be required to:
| — | elucidate the mode/mechanism of action |
| — | provide sufficient evidence for relevant adverse effects |
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
|
| ADS | |
| 8.13.4. | Immunotoxicity including developmental immunotoxicity
If there is any evidence, from skin sensitisation, repeat dose or reproduction toxicity studies, that the active substance may have immunotoxic properties then additional information or specific studies shall be required to:
| — | elucidate the mode/mechanism of action |
| — | provide sufficient evidence for relevant adverse effects in humans |
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
|
| ADS | |
| 8.13.5. | Mechanistic data — any studies necessary to clarify effects reported in toxicity studies |
| ADS | |
| 8.14. | Studies related to the exposure of humans to the active substance |
| ADS | |
| 8.15. | Toxic effects on livestock and pets |
| ADS | |
| 8.16. | Food and feeding stuffs studies including for food-producing animals and their products (milk, eggs and honey)
Additional information related to the exposure of humans to the active substance contained in biocidal products
|
| ADS | |
| 8.16.1. | Proposed acceptable residue levels i.e. maximum residue limits (MRL) and the justification of their acceptability |
| ADS | |
| 8.16.2. | Behaviour of the residue of the active substance on the treated or contaminated food or feeding stuffs including the kinetics of disappearance
Residue 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
|
| ADS | |
| 8.16.3. | Overall material balance for the active substance
Sufficient 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
|
| ADS | |
| 8.16.4. | Estimation of potential or actual exposure of humans to the active substance and residues through diet and other means |
| ADS | |
| 8.16.5. | If 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 |
| ADS | |
| 8.16.6. | Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the active substance |
| ADS | |
| 8.16.7. | Any other available information that is relevant
It may be appropriate to include information on migration into food, especially in the case of treatment of food contact materials
|
| ADS | |
| 8.16.8. | Summary and evaluation of data submitted under 8.16.1 to 8.16.8
It 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
|
| ADS | |
| 8.17. | If 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 |
| ADS | |
| 8.18. | Summary of mammalian toxicology
Provide overall evaluation and conclusion with regard to all toxicological data and any other information concerning the active substances including NOAEL
|
| | |
9.
ECOTOXICOLOGICAL STUDIES
|
9.1.
Toxicity to Aquatic Organisms
|
| 9.1.1. | Short-term toxicity testing on fish
When short-term fish toxicity data is required the threshold approach (tiered strategy) should be applied
|
| | The study does not need to be conducted if:
| — | a valid long-term aquatic toxicity study on fish is available |
|
9.1.2.
Short-term toxicity testing on aquatic invertebrates
|
| | |
| ADS | |
9.1.3.
Growth inhibition study on algae
|
| 9.1.3.1. | Effects on growth rate of green algae |
| | |
| 9.1.3.2. | Effects on growth rate of cyanobacteria or diatoms |
| | |
| | The experimental determination may not need to be carried out if:
| — | it 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 |
|
| 9.1.4.1. | Estimation methods |
|
| 9.1.4.2. | Experimental determination |
|
| 9.1.5. | Inhibition of microbial activity
The 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
|
| | |
| 9.1.6. | Further Toxicity Studies on Aquatic Organisms
If 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
|
| ADS | |
| 9.1.6.1. | Long term toxicity testing on Fish
| (a) | Fish Early Life Stage (FELS) Test |
| (b) | Fish short term toxicity test on embryo and sack fry stages |
| (c) | Fish juvenile growth test |
| (d) | Fish full life cycle test |
|
| ADS | |
| 9.1.6.2. | Long term toxicity testing on invertebrates
| (a) | Daphnia growth and reproduction study |
| (b) | Other species reproduction and growth (e.g. Mysid) |
| (c) | Other species development and emergence (e.g. Chironomus) |
|
| ADS | |
| 9.1.7. | Bioaccumulation in an appropriate aquatic species |
| ADS | |
| 9.1.8. | Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk |
| ADS | |
| 9.1.9. | Studies on sediment- dwelling organisms |
| ADS | |
| 9.1.10. | Effects on aquatic macrophytes |
| ADS | |
| 9.2. | Terrestrial toxicity, initial tests |
| ADS | |
| 9.2.1. | Effects on soil micro-organisms |
|
| 9.2.2. | Effects on earthworms or other soil- dwelling non-target invertebrates |
|
| 9.2.3. | Acute toxicity to plants |
|
| 9.3. | Terrestrial tests, long term |
| ADS | |
| 9.3.1. | Reproduction study with earthworms or other soil-dwelling non-target invertebrates |
|
| ADS | For endpoint 9.4.3 the study does not need to be conducted if:
| — | the dietary toxicity study shows that the LC50 is above 2 000 mg/kg |
|
| 9.4.1. | Acute oral toxicity |
|
| 9.4.2. | Short-term toxicity — eight-day dietary study in at least one species (other than chickens, ducks and geese) |
|
| 9.4.3. | Effects on reproduction |
|
| 9.5. | Effects on arthropods |
| ADS | |
| 9.5.1. | Effects on honeybees |
|
| 9.5.2. | Other non-target terrestrial arthropods, e.g. predators |
|
| 9.6. | Bioconcentration, terrestrial |
| ADS | |
| 9.7. | Bioaccumulation, terrestrial |
| ADS | |
| 9.8. | Effects on other non-target, non-aquatic organisms |
| ADS | |
| ADS | Data 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 |
| 9.9.1. | Acute oral toxicity |
|
| 9.9.2. | Short term toxicity |
|
|
| 9.9.4. | Effects on reproduction |
|
| 9.10. | Identification of endocrine activity |
| ADS | |
10.
ENVIRONMENTAL FATE AND BEHAVIOUR
|
10.1.
Fate and behaviour in water and sediment
|
10.1.1.
Degradation, initial studies
|
| If 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 | | |
| | |
| (a) | Hydrolysis as a function of pH and identification of breakdown products
| — | The identification of breakdown products is required when the breakdown products at any sampling time are present at ≥ 10 % |
|
| | |
| (b) | Phototransformation in water, including identification of transformation products |
| | |
| | |
| (a) | Ready biodegradability |
| | |
| (b) | Inherent biodegradability (where appropriate) |
| | |
| 10.1.2. | Adsorption/desorption |
| | |
10.1.3.
Rate and route of degradation including identification of metabolites and degradation products
|
| 10.1.3.1. | Biological sewage treatment |
| | |
| (a) | Aerobic biodegradation |
| ADS | |
| (b) | Anaerobic biodegradation |
| ADS | |
| ADS | |
| 10.1.3.2. | Biodegradation in freshwater |
| | |
| (a) | Aerobic aquatic degradation study |
| ADS | |
| (b) | Water/sediment degradation test |
| ADS | |
| 10.1.3.3. | Biodegradation in sea water |
| ADS | |
| 10.1.3.4. | Biodegradation during manure storage |
| ADS | |
| 10.1.4. | Adsorption and desorption in water/aquatic sediment systems and, where relevant, adsorption and desorption of metabolites and degradation products |
| ADS | |
| 10.1.5. | Field study on accumulation in sediment |
| ADS | |
| 10.1.6. | Inorganic substances: information on fate and behaviour in water |
| ADS | |
| 10.2. | Fate and behaviour in soil |
| ADS | |
| 10.2.1. | Laboratory 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
Laboratory studies on rate of degradation in three additional soil types
|
| ADS | |
| 10.2.2. | Field studies, two soil types |
| ADS | |
| 10.2.3. | Soil accumulation studies |
| ADS | |
| 10.2.4. | Adsorption and desorption in at least three soil types and, where relevant, adsorption and desorption of metabolites and degradation products |
| ADS | |
| 10.2.5. | Further studies on sorption |
| | |
| 10.2.6. | Mobility in at least three soil types and where relevant mobility of metabolites and degradation products |
| ADS | |
| 10.2.6.1. | Column leaching studies |
| | |
| 10.2.6.2. | Lysimeter studies |
| | |
| 10.2.6.3. | Field leaching studies |
| | |
| 10.2.7. | Extent and nature of bound residues
The determination and characteristics of bound residues is recommended to be combined with a soil simulation study
|
| ADS | |
| 10.2.8. | Other soil degradation studies |
| ADS | |
| 10.2.9. | Inorganic substances: information on fate and behaviour in soil |
| | |
10.3.
Fate and behaviour in air
|
| 10.3.1. | Phototransformation in air (estimation method)
Identification of transformation products
|
| | |
| 10.3.2. | Fate and behaviour in air, further studies |
| ADS | |
| 10.4. | Additional studies on fate and behaviour in the environment |
| ADS | |
| 10.5. | Definition of the residue |
| ADS | |
| 10.5.1. | Definition of the residue for risk assessment |
|
| 10.5.2. | Definition of the residue for monitoring |
| | |
| ADS | |
| 10.6.1. | Identification of all degradation products (> 10 %) must be included in the studies on degradation in soil, water and sediments |
| | |
11.
MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT
|
| 11.1. | Recommended methods and precautions concerning handling, use, storage, transport or fire |
| | |
| 11.2. | In case of fire, nature of reaction products, combustion gases etc. |
| | |
| 11.3. | Emergency measures in case of accident |
| | |
| 11.4. | Possibility of destruction or decontamination following release in or on the following:
| (b) | water, including drinking water |
|
| | |
| 11.5. | Procedures for waste management of the active substance for industry or professional users |
| | |
| 11.6. | Possibility of reuse or recycling |
| | |
| 11.7. | Possibility of neutralisation of effects |
| | |
| 11.8. | Conditions for controlled discharge including leachate qualities on disposal |
| | |
| 11.9. | Conditions for controlled incineration |
| | |
| 11.10. | Identification 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 (6), 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 (7), 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 (8), of Part B of Annex I to Directive 98/83/EC or Annexes VIII and X to Directive 2000/60/EC |
| | |
12.
CLASSIFICATION, LABELLING AND PACKAGING
|
| 12.1. | State any existing classification and labelling |
| | |
12.2.
The hazard classification of the substance resulting from the application of Regulation (EC) No 1272/2008
|
| In addition, for each entry, the reasons why no classification is given for an endpoint should be provided | | |
| 12.2.1. | Hazard classification |
| | |
| | |
| | |
| | |
| 12.2.5. | Precautionary statements including prevention, response, storage and disposal |
| | |
| 12.3. | Specific concentration limits, where applicable, resulting from the application of Regulation (EC) No 1272/2008 |
| | |
| 13. | SUMMARY AND EVALUATION
The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed
|
| | |
Column 1
Information required
| Column 2
All data is CDS unless indicated as ADS
| Column 3
Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates
|
1.
APPLICANT
|
| | |
| | |
| 1.3. | Manufacturer (name, address and location of manufacturing plant) |
| | |
2.
IDENTITY OF THE MICRO-ORGANISM
|
| 2.1. | Common name of the micro-organism (including alternative and superseded names) |
| | |
| 2.2. | Taxonomic name and strain |
| | |
| 2.3. | Collection and culture reference number where the culture is deposited |
| | |
| 2.4. | Methods, procedures and criteria used to establish the presence and identity of the micro-organism |
| | |
| 2.5. | Specification of the technical grade active ingredient |
| | |
| 2.6. | Method of production and quality control |
| | |
| 2.7. | Content of the micro-organism |
| | |
| 2.8. | Identity and content of impurities, additives, contaminating micro-organisms |
| | |
| 2.9. | Analytical profile of batches |
| | |
3.
BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM
|
3.1.
General information on the micro-organism
|
| 3.1.1. | Historical background |
| | |
| | |
| 3.1.3. | Origin, natural occurrence and geographical distribution |
| | |
| 3.2. | Development stages/life cycle of the micro-organism |
| | |
| 3.3. | Relationships to known plant or animal or human pathogens |
| | |
| 3.4. | Genetic stability and factors affecting it |
| | |
| 3.5. | Information on the production of metabolites (especially toxins) |
| | |
| 3.6. | Production and resistance to antibiotics and other anti-microbial agents |
| | |
| 3.7. | Robustness to environmental factors |
| | |
| 3.8. | Further information on the micro-organism |
| | |
4.
METHODS OF DETECTION AND IDENTIFICATION
|
| 4.1. | Analytical methods for the analysis of the micro-organism as manufactured |
| | |
| 4.2. | Methods used for monitoring purposes to determine and quantify residues (viable or non-viable) |
| | |
5.
EFFECTIVENESS AGAINST TARGET ORGANISM
|
| 5.1. | Function and mode of control e.g. attracting, killing, inhibiting |
| | |
| 5.2. | Infectiveness, dispersal and colonisation ability |
| | |
| 5.3. | Representative organism(s) controlled and products, organisms or objects to be protected |
| | |
| 5.4. | Effects on representative target organism(s)
Effects on materials, substances and products
|
| | |
| 5.5. | Likely concentration at which the micro-organism will be used |
| | |
| 5.6. | Mode of action (including time delay) |
| | |
| | |
5.8.
Any known limitations on efficacy
|
| 5.8.1. | Information on the occurrence or possible occurrence of the development of resistance of the target organism(s) and appropriate management strategies |
| | |
| 5.8.2. | Observations on undesirable or unintended side effects |
| | |
| 5.8.3. | Host specificity, range and effects on species other than the target organism |
| | |
| 5.9. | Methods to prevent loss of virulence of seed stock of the micro-organism |
| | |
6.
INTENDED USES AND EXPOSURE
|
| 6.1. | Field of use(s) envisaged |
| | |
| | |
| 6.3. | Detailed description of the use pattern(s) |
| | |
| 6.4. | Category of users for which the micro-organism should be approved |
| | |
6.5.
Exposure data applying, as appropriate, the methodologies described in Section 5 of Annex I to Regulation (EC) No 1907/2006
|
| 6.5.1. | Information on human exposure associated with the intended uses and disposal of the active substance |
| | |
| 6.5.2. | Information on environmental exposure associated with the intended uses and disposal of the active substance |
| | |
| 6.5.3. | Information on exposure of food-producing animals and food and feeding stuffs associated with the intended uses of the active substance |
| | |
| 7. | EFFECT ON HUMAN AND ANIMAL HEALTH |
| | Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. |
7.1.
Basic information
|
| | |
| 7.1.2. | Medical surveillance on manufacturing plant personnel |
| | |
| 7.1.3. | Sensitisation/allergenicity observations |
| | |
| 7.1.4. | Direct observation, e.g. clinical cases
Any pathogenicity and infectiveness to humans and other mammals under conditions of immunosuppression
|
| | |
7.2.
Basic studies
|
| | |
7.2.2.
Acute toxicity, pathogenicity, and infectiveness
|
| 7.2.2.1. | Acute oral toxicity, pathogenicity and infectiveness |
| | |
| 7.2.2.2. | Acute inhalatory toxicity, pathogenicity and infectiveness |
| ADS | |
| 7.2.2.3. | Intraperitoneal/subcutaneous single dose |
| ADS | |
| 7.2.3. | In vitro genotoxicity testing |
| | |
| | |
| 7.2.5. | Information on short-term toxicity and pathogenicity |
| ADS | |
| 7.2.5.1. | Health effects after repeated inhalatory exposure |
| ADS | |
| 7.2.6. | Proposed treatment: first aid measures, medical treatment |
| | |
| 7.3. | Specific toxicity, pathogenicity and infectiveness studies |
| ADS | |
| 7.4. | Genotoxicity — in vivo studies in somatic cells |
| ADS | |
| 7.5. | Genotoxicity — in vivo studies in germ cells |
| ADS | |
| 7.6. | Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation |
| | |
| 7.7. | Residues in or on treated articles, food and feedingstuffs |
| ADS | |
| 7.7.1. | Persistence and likelihood of multiplication in or on treated articles, feedingstuffs or foodstuffs |
| ADS | |
| 7.7.2. | Further information required |
| ADS | |
| 7.7.2.1. | Non-viable residues |
| ADS | |
| ADS | |
| 7.8. | Summary and evaluation of residues in or on treated articles, food and feedingstuffs |
| ADS | |
| 8. | EFFECTS ON NON-TARGET ORGANISMS |
| | Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. |
8.1.
Effects on aquatic organisms
|
| | |
| 8.1.2. | Effects on freshwater invertebrates |
| | |
| 8.1.3. | Effects on algae growth |
| | |
| 8.1.4. | Effects on plants other than algae |
| ADS | |
| 8.2. | Effects on earthworms |
| | |
| 8.3. | Effects on soil micro-organisms |
| | |
| | |
| | |
| 8.6. | Effects on arthropods other than bees |
| | |
| ADS | |
| ADS | |
| ADS | |
| 8.7.3. | Other relevant species and processes |
| ADS | |
| 8.8. | Summary and evaluation of effects on non-target organisms |
| | |
9.
ENVIRONMENTAL FATE AND BEHAVIOUR
|
9.1.
Persistence and multiplication
|
| | |
| | |
| | |
| | |
| 9.1.5. | Summary and evaluation of fate and behaviour in the environment |
| | |
10.
MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT
|
| 10.1. | Recommended methods and precautions concerning handling, storage, transport or fire |
| | |
| 10.2. | Emergency measures in case of an accident |
| | |
| 10.3. | Procedures for destruction or decontamination |
| | |
| 10.4. | Procedures for waste management |
| | |
| 10.5. | Monitoring plan to be used for the active micro-organism including handling, storage, transport and use |
| | |
11.
CLASSIFICATION, LABELLING AND PACKAGING OF THE MICRO-ORGANISM
|
| 11.1. | Relevant risk group specified in Article 2 of Directive 2000/54/EC |
| | |
| 12. | SUMMARY AND EVALUATION
The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed
|
| | |
Column 1
Information required:
| Column 2
All data is CDS unless indicated as ADS
| Column 3
Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates
|
1.
APPLICANT
|
| 1.1. | Name and address, etc. |
| | |
| | |
| 1.3. | Manufacturer and formulator of the biocidal product and the active substance(s) (names, addresses, including location of plant(s)) |
| | |
2.
IDENTITY OF THE BIOCIDAL PRODUCT
|
| 2.1. | Trade name or proposed trade name |
| | |
| 2.2. | Manufacturer’s development code and number of the product, if appropriate |
| | |
| 2.3. | Complete 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.
In 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
|
| | |
| 2.4. | Formulation type and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder, solution |
| | |
3.
PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES
|
3.1.
Appearance (at 20 °C and 101,3 kPa)
|
| 3.1.1. | Physical state (at 20 °C and 101,3 kPa) |
| | |
| 3.1.2. | Colour (at 20 °C and 101,3 kPa) |
| | |
| 3.1.3. | Odour (at 20 °C and 101,3 kPa) |
| | |
| 3.2. | Acidity/alkalinity
The test is applicable when the pH of the biocidal product or its dispersion in water (1 %) is outside the pH range 4-10
|
| | |
| 3.3. | Relative density (liquids) and bulk, tap density (solids) |
| | |
3.4.
Storage stability, stability and shelf-life
|
3.4.1.
Storage stability tests
|
| 3.4.1.1. | Accelerated storage test |
| | |
| 3.4.1.2. | Long term storage test at ambient temperature |
| | |
| 3.4.1.3. | Low temperature stability test (liquids) |
| | |
3.4.2.
Effects on content of the active substance and technical characteristics of the biocidal product
|
| | |
| 3.4.2.2. | Temperature and humidity |
| | |
| 3.4.2.3. | Reactivity towards container material |
| | |
3.5.
Technical characteristics of the biocidal product
|
| | |
| 3.5.2. | Suspensibility, spontaneity and dispersion stability |
| | |
| 3.5.3. | Wet sieve analysis and dry sieve test |
| | |
| 3.5.4. | Emulsifiability, re-emulsifiability and emulsion stability |
| | |
| 3.5.5. | Disintegration time |
| | |
| 3.5.6. | Particle size distribution, content of dust/fines, attrition, friability |
| | |
| | |
| 3.5.8. | Flowability/Pourability/Dustability |
| | |
| 3.5.9. | Burning rate — smoke generators |
| | |
| 3.5.10. | Burning completeness — smoke generators |
| | |
| 3.5.11. | Composition of smoke — smoke generators |
| | |
| 3.5.12. | Spraying pattern — aerosols |
| | |
| 3.5.13. | Other technical characteristics |
| | |
3.6.
Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised
|
| 3.6.1. | Physical compatibility |
| | |
| 3.6.2. | Chemical compatibility |
| | |
| 3.7. | Degree of dissolution and dilution stability |
| | |
| | |
| | |
4.
PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS
|
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| 4.8. | Self-reactive substances and mixtures |
| | |
| | |
| | |
| 4.11. | Self-heating substances and mixtures |
| | |
| 4.12. | Substances and mixtures which in contact with water emit flammable gases |
| | |
| | |
| | |
| | |
| | |
4.17.
Additional physical indications of hazard
|
| 4.17.1. | Auto-ignition temperatures of products (liquids and gases) |
| | |
| 4.17.2. | Relative self-ignition temperature for solids |
| | |
| 4.17.3. | Dust explosion hazard |
| | |
5.
METHODS OF DETECTION AND IDENTIFICATION
|
| 5.1. | Analytical method including validation parameters for determining the concentration of the active substance(s), residues, relevant impurities and substances of concern in the biocidal product |
| | |
| 5.2. | In 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: |
| ADS | |
| ADS | |
| ADS | |
| 5.2.3. | Water (including drinking water) and sediment |
| ADS | |
| 5.2.4. | Animal and human body fluids and tissues |
| ADS | |
| 5.3. | Analytical 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) |
| ADS | |
6.
EFFECTIVENESS AGAINST TARGET ORGANISMS
|
| 6.1. | Function, e.g. fungicide, rodenticide, insecticide, bactericide
Mode of control e.g. attracting, killing, inhibiting
|
| | |
| 6.2. | Representative organism(s) to be controlled and products, organisms or objects to be protected |
| | |
| 6.3. | Effects on representative target organisms |
| | |
| 6.4. | Likely concentration at which the active substance will be used |
| | |
| 6.5. | Mode of action (including time delay) |
| | |
| 6.6. | The proposed label claims for the product and, where label claims are made, for treated articles |
| | |
| 6.7. | Efficacy data to support these claims, including any available standard protocols, laboratory tests or field trials used including performance standards where appropriate and relevant |
| | |
6.8.
Any known limitations on efficacy
|
| 6.8.1. | Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies |
| | |
| 6.8.2. | Observations on undesirable or unintended side effects e.g. on beneficial and other non-target organisms |
| | |
| 6.9. | Summary and evaluation |
| | |
7.
INTENDED USES AND EXPOSURE
|
| 7.1. | Field(s) of use envisaged for biocidal products and, where appropriate, treated articles |
| | |
| | |
| 7.3. | Detailed description of intended use pattern(s) for biocidal products and, where appropriate, treated articles |
| | |
| 7.4. | User e.g. industrial, trained professional, professional or general public (non-professional) |
| | |
| 7.5. | Likely tonnage to be placed on the market per year and, where relevant, for different use categories |
| | |
| 7.6. | Method of application and a description of this method |
| | |
| 7.7. | Application 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 |
| | |
| 7.8. | Number 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 |
| | |
| 7.9. | Proposed instructions for use |
| | |
7.10.
Exposure data in conformity with Annex VI to this Regulation
|
| 7.10.1. | Information on human exposure associated with production and formulation, proposed/expected uses and disposal |
| | |
| 7.10.2. | Information on environmental exposure associated with production and formulation, proposed/expected uses and disposal |
| | |
| 7.10.3. | Information on exposure from treated articles including leaching data (either laboratory studies or model data) |
| | |
| 7.10.4. | Information 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 |
| | |
8.
TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS
|
| 8.1. | Skin corrosion or skin irritation
The assessment of this endpoint shall be carried out according to the sequential testing strategy for dermal irritation and corrosion set out in the Appendix to Test Guideline B.4. Acute Toxicity-Dermal Irritation/Corrosion (Annex B.4. to Regulation (EC) No 440/2008)
|
| | Testing on the product/mixture does not need to be conducted if:
| — | there are valid data available on each of the components in the mixture sufficient 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 |
|
| 8.2. | Eye irritation (1)
The assessment of this endpoint shall be carried out according to the sequential testing strategy for eye irritation and corrosion as set down in the Appendix to Test Guideline B.5.Acute Toxicity: Eye Irritation/Corrosion (Annex B.5. to Regulation (EC) No 440/2008)
|
| | Testing on the product/mixture does not need to be conducted if:
| — | 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 Directive 1999/45/ECand Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
|
| 8.3. | Skin sensitisationThe assessment of this endpoint shall comprise the following consecutive steps:
| 1. | an assessment of the available human, animal and alternative data |
| 2. | in vivo testing
The Murine Local Lymph Node Assay (LLNA) including, where appropriate, the reduced variant of the assay, is the first-choice method for in vivo testing. If another skin sensitisation test is used justification shall be provided
|
|
| | Testing on the product/mixture does not need to be conducted if:
| — | 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 Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
| — | the available information indicates that the product should be classified for skin sensitisation or corrosivity; or |
| — | the substance is a strong acid (pH < 2,0) or base (pH > 11,5) |
|
| 8.4. | Respiratory sensitisation |
| ADS | Testing on the product/mixture does not need to be conducted if:
| — | 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 Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
|
| 8.5. | Acute toxicity
| — | Classification using the tiered approach to classification of mixtures for acute toxicity in Regulation (EC) No 1272/2008 is the default approach |
|
| | Testing on the product/mixture does not need to be conducted if:
| — | 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 Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
|
| | |
| | |
| | |
| 8.5.4. | For 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 |
| | Testing on the mixture of products does not need to be conducted if:
| — | 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 Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
|
| 8.6. | Information on dermal absorption
Information on dermal absorption when exposure occurs to the biocidal product. The assessment of this endpoint shall proceed using a tiered approach
|
| | |
| 8.7. | Available toxicological data relating to:
| — | non-active substance(s) (i.e. substance(s) of concern), or |
| — | a mixture that a substance(s) of concern is a component of |
If 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
|
| | Testing on the product/mixture does not need to be conducted if:
| — | 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 Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP) |
|
| 8.8. | Food and feedingstuffs studies |
| ADS | |
| 8.8.1. | If 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 |
| ADS | |
| 8.9. | Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the biocidal product |
| ADS | |
| 8.10. | Other test(s) related to the exposure to humans
Suitable test(s) and a reasoned case will be required for the biocidal product
In addition, for certain biocides which are applied directly or around livestock (including horses) residue studies might be needed
|
| ADS | |
9.
ECOTOXICOLOGICAL STUDIES
|
| 9.1. | Information 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
| — | Where 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) |
| — | Where 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 |
|
| | |
| 9.2. | Further Ecotoxicological studies
Further 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
|
| | |
| 9.3. | Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk |
| ADS | Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment |
9.4.
If the biocidal product is in the form of bait or granules the following studies may be required:
|
| 9.4.1. | Supervised trials to assess risks to non-target organisms under field conditions |
| | |
| 9.4.2. | Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought to be at risk |
| | |
| 9.5. | Secondary ecological effect e.g. when a large proportion of a specific habitat type is treated |
| ADS | |
10.
ENVIRONMENTAL FATE AND BEHAVIOUR
|
| The test requirements below are applicable only to the relevant components of the biocidal product | | |
| 10.1. | Foreseeable routes of entry into the environment on the basis of the use envisaged |
| | |
| 10.2. | Further studies on fate and behaviour in the environment
Further 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.
For 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
|
| ADS | |
| ADS | |
| 10.4. | Testing for distribution and dissipation in the following: |
| ADS | |
| ADS | |
| 10.4.2. | Water and sediment |
| ADS | |
| ADS | |
| 10.5. | If 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 |
| ADS | |
| 10.6. | If 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 |
| ADS | |
11.
MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT
|
| 11.1. | Recommended methods and precautions concerning handling, use, storage, disposal, transport or fire |
| | |
| 11.2. | Identity of relevant combustion products in cases of fire |
| | |
| 11.3. | Specific treatment in case of an accident, e.g. first-aid measures, antidotes, medical treatment if available; emergency measures to protect the environment |
| | |
11.4.
Possibility of destruction or decontamination following release in or on the following:
|
| | |
| 11.4.2. | Water, including drinking water |
| | |
| | |
| 11.5. | Procedures 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) |
| | |
| 11.6. | Procedures for cleaning application equipment where relevant |
| | |
| 11.7. | Specify any repellents or poison control measures included in the product that are present to prevent action against non-target organisms |
| | |
12.
CLASSIFICATION, LABELLING, AND PACKAGING
|
As 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.
Example labels, instructions for use and safety data sheets shall be provided
| | |
| 12.1. | Hazard classification |
| | |
| | |
| | |
| | |
| 12.5. | Precautionary statements including prevention, response, storage and disposal |
| | |
| 12.6. | Proposals for safety-data sheets should be provided, where appropriate |
| | |
| 12.7. | Packaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included |
| | |
| 13. | EVALUATION AND SUMMARY
The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed
|
| | |
Column 1
Information required:
| Column 2
All data is CDS unless indicated as ADS
| Column 3
Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates
|
1.
APPLICANT
|
| | |
| | |
| 1.3. | Manufacturer and formulator of the biocidal product and the micro-organism(s) (names, addresses, including location of plant(s)) |
| | |
2.
IDENTITY OF THE BIOCIDAL PRODUCTS
|
| 2.1. | Trade name or proposed trade name |
| | |
| 2.2. | Manufacturer’s development code and number of the biocidal product, if appropriate |
| | |
| 2.3. | Detailed quantitative (g/kg, g/l or % w/w (v/v)) and qualitative information on the constitution, composition and function of the biocidal product, e.g. micro-organism, active substance(s) and product non-active substances and any other relevant components.
All relevant information on individual ingredients and the final composition of the biocidal product shall be given
|
| | |
| 2.4. | Formulation type and nature of the biocidal product |
| | |
3.
BIOLOGICAL, PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT
|
| 3.1. | Biological properties of the micro-organism in the biocidal product |
| | |
3.2.
Appearance (at 20 °C and 101,3 kPa)
|
| 3.2.1. | Colour (at 20 °C and 101,3 kPa) |
| | |
| 3.2.2. | Odour (at 20 °C and 101,3 kPa) |
| | |
| 3.3. | Acidity, alkalinity and pH value |
| | |
| | |
3.5.
Storage stability, stability and shelf-life
|
| | |
| 3.5.2. | Effects of temperature and humidity |
| | |
| 3.5.3. | Reactivity towards the container |
| | |
| 3.5.4. | Other factors affecting stability |
| | |
3.6.
Technical characteristics of the biocidal product
|
| | |
| 3.6.2. | Suspensibility and suspension stability |
| | |
| 3.6.3. | Wet sieve analysis and dry sieve test |
| | |
| 3.6.4. | Emulsifiability, re-emulsifiability, emulsion stability |
| | |
| 3.6.5. | Particle size distribution content of dust/fines, attrition and friability |
| | |
| | |
| 3.6.7. | Flowability/Pourability/Dustability |
| | |
| 3.6.8. | Burning rate — smoke generators |
| | |
| 3.6.9. | Burning completeness — smoke generators |
| | |
| 3.6.10. | Composition of smoke — smoke generators |
| | |
| 3.6.11. | Spraying patterns — aerosols |
| | |
| 3.6.12. | Other technical characteristics |
| | |
3.7.
Physical, chemical and biological compatibility with other products including biocidal products with which its use is to be authorised or registered
|
| 3.7.1. | Physical compatibility |
| | |
| 3.7.2. | Chemical compatibility |
| | |
| 3.7.3. | Biological compatibility |
| | |
| | |
| | |
4.
PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS
|
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
4.12.
Other physical indications of hazard
|
| 4.12.1. | Auto-ignition temperatures of products (liquids and gases) |
| | |
| 4.12.2. | Relative self-ignition temperature for solids |
| | |
| 4.12.3. | Dust explosion hazard |
| | |
5.
METHODS OF DETECTION AND IDENTIFICATION
|
| 5.1. | Analytical method for determining the concentration of the micro-organism(s) and substances of concern in the biocidal product |
| | |
| 5.2. | Analytical 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) |
| ADS | |
6.
EFFECTIVENESS AGAINST TARGET ORGANISM
|
| 6.1. | Function and mode of control |
| | |
| 6.2. | Representative pest organism(s) to be controlled and products, organisms or objects to be protected |
| | |
| 6.3. | Effects on representative target organisms |
| | |
| 6.4. | Likely concentration at which micro-organism will be used |
| | |
| | |
| 6.6. | The proposed label claims for the product |
| | |
| 6.7. | Efficacy data to support these claims, including any available standard protocols, laboratory tests, or field trials used including performance standards, where appropriate and relevant |
| | |
6.8.
Any other known limitations on efficacy including resistance
|
| 6.8.1. | Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies |
| | |
| 6.8.2. | Observations on undesirable or unintended side effects |
| | |
7.
INTENDED USES AND EXPOSURE
|
| 7.1. | Field of use envisaged |
| | |
| | |
| 7.3. | Detailed description of intended use |
| | |
| 7.4. | User e.g. industrial, trained professional, professional or general public (non-professional) |
| | |
| 7.5. | Method of application and a description of this method |
| | |
| 7.6. | Application 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) |
| | |
| 7.7. | Number and timing of applications and duration of protection
Any 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
|
| | |
| 7.8. | Proposed instructions for use |
| | |
7.9.
Exposure data
|
| 7.9.1. | Information on human exposure associated with the proposed/expected uses and disposal |
| | |
| 7.9.2. | Information on environmental exposure associated with the proposed/expected uses and disposal |
| | |
| 8. | TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS |
| | Testing on the product/mixture does not need to be conducted if:
| — | 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 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 |
|
| 8.1. | Skin corrosion or irritation |
| | |
| | |
| | |
| 8.4. | Respiratory sensitisation |
| ADS | |
| 8.5. | Acute toxicity
| — | Classification using the tiered approach to classification of mixtures for acute toxicity in Regulation (EC) No 1272/2008 is the default approach |
|
| | |
| | |
| | |
| | |
| 8.5.4. | Additional acute toxicity studies |
| | |
| 8.6. | Information on dermal absorption if required |
| | |
| 8.7. | Available toxicological data relating to:
| — | non-active substance(s) (i.e. substance(s) of concern), or |
| — | a mixture that a substance(s) of concern is a component of
If 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
|
|
| | Testing on the product/mixture does not need to be conducted if:
| — | 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 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 |
|
| 8.8. | Supplementary studies for combinations of biocidal products
For 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
|
| | Testing on the mixture of products does not need to be conducted if:
| — | 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 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 |
|
| 8.9. | Residues in or on treated articles, food and feedingstuffs |
| ADS | |
9.
ECOTOXICOLOGICAL STUDIES
|
| 9.1. | Information 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
| — | Where 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) |
| — | Where 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 |
|
| | |
| 9.2. | Further ecotoxicological studies
Further 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
|
| | |
| 9.3. | Effects on any other specific non-target organisms (flora and fauna) believed to be at risk |
| ADS | Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment |
| 9.4. | If the biocidal product is in the form of bait or granules |
| ADS | |
| 9.4.1. | Supervised trials to assess risks to non-target organisms under field conditions |
|
| 9.4.2. | Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought to be at risk |
|
| 9.5. | Secondary ecological effect e.g. when a large proportion of a specific habitat type is treated |
| ADS | |
10.
ENVIRONMENTAL FATE AND BEHAVIOUR
|
| 10.1. | Foreseeable routes of entry into the environment on the basis of the use envisaged |
| | |
| 10.2. | Further studies on fate and behaviour in the environment
Where relevant, all the information required in Section 9 of Annex II ‘Micro-organisms’ may be required for the product
For 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
|
| ADS | |
| ADS | |
| 10.4. | If 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 |
| ADS | |
11.
MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT
|
| 11.1. | Recommended methods and precautions concerning: handling, storage, transport or fire |
| | |
| 11.2. | Measures in the case of an accident |
| | |
11.3.
Procedures for destruction or decontamination of the biocidal product and its packaging
|
| 11.3.1. | Controlled incineration |
| | |
| | |
| 11.4. | Packaging and compatibility of the biocidal product with proposed packaging materials |
| | |
| 11.5. | Procedures for cleaning application equipment where relevant |
| | |
| 11.6. | Monitoring 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 |
| | |
12.
CLASSIFICATION, LABELLING AND PACKAGING
|
| Example labels, instructions for use and safety data sheets shall be provided | | |
| 12.1. | Indication on the need for the biocidal product to carry the biohazard sign specified in Annex II to Directive 2000/54/EC |
| | |
| 12.2. | Precautionary statements including prevention, response, storage and disposal |
| | |
| 12.3. | Proposals for safety-data sheets should be provided, where appropriate |
| | |
| 12.4. | Packaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included |
| | |
| 13. | SUMMARY AND EVALUATION
The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed
|
| | |
