With regard to the ADS, the data elements to be provided for a specific active substance shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the substance, existing data, information which is part of the CDS and the types of products in which the active substance will be used and the exposure patterns related to these uses.
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex II table. The general considerations regarding adaptation of information requirements as set out in Annex IV shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the Annex II table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates. The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria referred to in Article 4(1) are met.
The applicant should consult the detailed technical guidance regarding the application of this Annex and the preparation of the dossier referred to in point (a) of Article 6(1), which is available on the website of the Agency.
The applicant has the obligation to initiate a pre-submission consultation. In addition to the obligation set down in Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out.
Additional information may need to be submitted if it is necessary to carry out the evaluation as indicated in Article 8(2).
Information required to support the approval of an active substance is listed in the table below.
Conditions 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.
a The information provided should be for the purified active substance of stated specification or for the active substance as manufactured, if different. | ||
b The information provided should be for the purified active substance of stated specification. | ||
Column 1Information required | Column 2All data is CDS unless indicated as ADS | Column 3Specific 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 | ||
1.2.Contact person | ||
1.3.Active substance manufacturer (name, address and location of manufacturing plant(s)) | ||
2. IDENTITY OF THE ACTIVE SUBSTANCE | ||
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) | ||
2.2.Chemical name (IUPAC and CA nomenclature or other international chemical name(s)) | ||
2.3.Manufacturer’s development code number(s) | ||
2.4.CAS number plus EC, INDEX and CIPAC numbers | ||
2.5.Molecular and structural formula (including SMILES notation, if available and appropriate) | ||
2.6.Information on optical activity and full details of any isomeric composition (if applicable and appropriate) | ||
2.7.Molar mass | ||
2.8.Method of manufacture (syntheses pathway) of active substance including information on starting materials and solvents including suppliers, specifications and commercial availability | ||
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 | ||
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 | ||
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. | ||
2.12.The origin of the natural active substance or the precursor(s) of the active substance, e.g. an extract of a flower | ||
3. PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE | ||
3.1. Appearancea | ||
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) | ||
3.1.3.Colour (at 20 °C and 101,3 kPa) | ||
3.1.4.Odour (at 20 °C and 101,3 kPa) | ||
3.2.Melting/freezing pointb | ||
3.3.Acidity, alkalinity | ||
3.4.Boiling pointb | ||
3.5.Relative Densityb | ||
3.6.Absorption spectra data (UV/VIS, IR, NMR) and a mass spectrum, molar extinction coefficient at relevant wavelengths, where relevantb | ||
3.7. Vapour pressureb | ||
3.7.1.Henry’s law constant must always be stated for solids and liquids if it can be calculated | ||
3.8.Surface tensionb | ||
3.9.Water solubilityb | ||
3.10.Partition coefficient (n-octanol/water) and its pH dependencyb | ||
3.11.Thermal stability, identity of breakdown productsb | ||
3.12.Reactivity towards container material | ||
3.13.Dissociation constant | ADS | |
3.14.Granulometry | ||
3.15.Viscosity | ADS | |
3.16.Solubility in organic solvents, including effect of temperature on solubilityb | ADS | |
3.17.Stability in organic solvents used in biocidal products and identity of relevant breakdown productsa | ADS | |
4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS | ||
4.1.Explosives | ||
4.2.Flammable gases | ||
4.3.Flammable aerosols | ||
4.4.Oxidising gases | ||
4.5.Gases under pressure | ||
4.6.Flammable liquids | ||
4.7.Flammable solids | ||
4.8.Self-reactive substances and mixtures | ||
4.9.Pyrophoric liquids | ||
4.10.Pyrophoric solids | ||
4.11.Self-heating substances and mixtures | ||
4.12.Substances and mixtures which in contact with water emit flammable gases | ||
4.13.Oxidising liquids | ||
4.14.Oxidising solids | ||
4.15.Organic peroxides | ||
4.16.Corrosive to metals | ||
4.17. Additional physical indicators for hazards | ||
4.17.1.Auto-ignition temperature (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 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 | ||
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 | ||
5.2.1.Soil | ||
5.2.2.Air | ||
5.2.3.Water (surface, drinking etc.) and sediment | ||
5.2.4.Animal and human body fluids and tissues | ||
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 | ||
6.3.Effects on representative target organism(s) | ||
6.4.Likely concentration at which the active substance will be used in products and, where appropriate, in treated articles | ||
6.5.Mode of action (including time delay) | ||
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 | ||
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 | ||
7. INTENDED USES AND EXPOSURE | ||
7.1.Field of use(s) envisaged for biocidal products and, where appropriate, treated articles | ||
7.2.Product-type(s) | ||
7.3.Detailed description of the intended use pattern(s) including in treated articles | ||
7.4.Users 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 the envisaged major use categories | ||
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 | ||
7.6.2.Information on environmental exposure associated with the intended uses and disposal of the active substance | ||
7.6.3.Information on exposure of food- producing animals and food and feeding stuffs associated with the intended uses of the active substance | ||
7.6.4.Information on exposure from treated articles including leaching data (either laboratory studies or model data) | ||
8. TOXICOLOGICAL PROFILE FOR HUMAN AND ANIMAL INCLUDING METABOLISM | ||
8.1.Skin irritation or skin corrosionThe 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) | ||
8.2.Eye irritationThe 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 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 | Step 2 does not need to be conducted if:
| |
8.4.Respiratory sensitisation | ADS | |
8.5. Mutagenicity | ||
The assessment of this endpoint shall comprise the following consecutive steps:
| ||
8.5.1.In vitro gene mutation study in bacteria | ||
8.5.2.In vitro cytogenicity study in mammalian cells | ||
8.5.3.In vitro gene mutation study in mammalian cells | ||
8.6.In vivo genotoxicity studyThe assessment of this endpoint shall comprise the following consecutive steps:
| ADS | The study/ies do(es) not generally need to be conducted if:
|
8.7.Acute toxicityIn 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 study/ies do(es) not generally need to be conducted if:
| |
8.7.1.By oral routeThe Acute Toxic Class Method is the preferred method for the determination of this endpoint | The study need not be conducted if:
| |
8.7.2.By inhalationTesting by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account:
| ||
8.7.3.By dermal routeTesting by the dermal route is necessary only if:
| ||
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 mammalsAdditional studies might be required based on the outcome of the toxicokinetic and metabolism study conducted in rat. These further studies shall be required if:
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 toxicityIn 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:
Testing by the inhalation route shall be considered if:
| The repeated dose toxicity study (28 or 90 days) does not need to be conducted if:
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:
| |
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:
| |
8.9.3.Long-term repeated dose toxicity (≥ 12 months) | The long-term toxicity study (≥ 12 months) does not need to be conducted if:
| |
8.9.4.Further repeat dose studiesFurther 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:
| ADS | |
8.10.Reproductive toxicityFor 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:
| |
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 | ||
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.CarcinogenicitySee 8.11.1 for new study requirements | A carcinogenicity study does not need to be conducted if:
| |
8.11.1.Combined carcinogenicity study and long-term repeated dose toxicityRat, 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
| ||
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 studiesAdditional 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 | |
8.13.1.Phototoxicity | ADS | |
8.13.2.Neurotoxicity including developmental neurotoxicity
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 disruptionIf 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:
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 immunotoxicityIf 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:
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 disappearanceResidue 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 substanceSufficient 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 relevantIt 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 8.16.8It 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 toxicologyProvide 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 fishWhen short-term fish toxicity data is required the threshold approach (tiered strategy) should be applied | The study does not need to be conducted if:
| |
9.1.2. Short-term toxicity testing on aquatic invertebrates | ||
9.1.2.1.Daphnia magna | ||
9.1.2.2.Other species | 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 | ||
9.1.4.Bioconcentration | The experimental determination may not need to be carried out if:
| |
9.1.4.1.Estimation methods | ||
9.1.4.2.Experimental determination | ||
9.1.5.Inhibition of microbial activityThe 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 OrganismsIf 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 | ||
9.4.Effects on birds | ADS | For endpoint 9.4.3 the study does not need to be conducted if:
|
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 | |
9.9.Effects on mammals | 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 | ||
9.9.3.Long 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 | ||
10.1.1.1.Abiotic | ||
(a)Hydrolysis as a function of pH and identification of breakdown products
| ||
(b)Phototransformation in water, including identification of transformation products | ||
10.1.1.2.Biotic | ||
(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 | |
(c)STP simulation test | 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 conditionsLaboratory 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 residuesThe 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 | ||
10.6.Monitoring data | 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:(a) air (b) water, including drinking water (c) soil | ||
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 substancesc, 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 deteriorationd, 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 policye, 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 | ||
12.2.2.Hazard pictogram | ||
12.2.3.Signal word | ||
12.2.4.Hazard statements | ||
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 EVALUATIONThe key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed |
Information required to support the approval of an active substance is listed in the table below.
Conditions for not requiring a specific test that are set out in the appropriate test methods in Regulation (EC) No 440/2008 that are not repeated in column 3, also apply.
With regard to the ADS, the data elements to be provided for a specific biocidal product shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the product, existing data, information which is part of the CDS and the types of products and the exposure patterns related to these uses.
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex III table. The general considerations regarding adaptation of information requirements as set out in Annex IV to this Regulation shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates.
For some of the information requirements set out in this Annex, it may be possible to satisfy these requirements based on available information of the properties of the active substance(s) contained in the product and the properties of non-active substance(s) included in the product. For non-active substances, applicants shall use the information provided to them in the context of Title IV of Regulation (EC) No 1907/2006, where relevant, and the information made available by the Agency in accordance with point (e) of Article 77(2) of that Regulation.
The relevant calculation methods used for the classification of mixtures as laid down in Regulation (EC) No 1272/2008 shall, where appropriate, be applied in the hazard assessment of the biocidal product. Such calculation methods shall not be used if, in relation to a particular hazard, synergistic and antagonistic effects between the different substances contained in the product are considered likely.
Detailed technical guidance regarding the application of this Annex and the preparation of the dossier is available on the website of the Agency.
The applicant has the obligation to initiate a pre-submission consultation. In addition to the obligation set out in Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out.
Additional information may need to be submitted if necessary to carry out the evaluation as indicated in Article 29(3) or Article 44(2).
The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria in Article 19(1)(b) are met.
Information required to support the authorisation of a biocidal product is listed in the table below.
For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply.
a Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties. | ||
Column 1Information required: | Column 2All data is CDS unless indicated as ADS | Column 3Specific 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. | ||
1.2.Contact person | ||
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/alkalinityThe 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 | ||
3.4.2.1.Light | ||
3.4.2.2.Temperature and humidity | ||
3.4.2.3.Reactivity towards container material | ||
3.5. Technical characteristics of the biocidal product | ||
3.5.1.Wettability | ||
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 | ||
3.5.7.Persistent foaming | ||
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 | ||
3.8.Surface tension | ||
3.9.Viscosity | ||
4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS | ||
4.1.Explosives | ||
4.2.Flammable gases | ||
4.3.Flammable aerosols | ||
4.4.Oxidising gases | ||
4.5.Gases under pressure | ||
4.6.Flammable liquids | ||
4.7.Flammable solids | ||
4.8.Self-reactive substances and mixtures | ||
4.9.Pyrophoric liquids | ||
4.10.Pyrophoric solids | ||
4.11.Self-heating substances and mixtures | ||
4.12.Substances and mixtures which in contact with water emit flammable gases | ||
4.13.Oxidising liquids | ||
4.14.Oxidising solids | ||
4.15.Organic peroxides | ||
4.16.Corrosive to metals | ||
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 | |
5.2.1.Soil | ADS | |
5.2.2.Air | 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, bactericideMode 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 | ||
7.2.Product-type | ||
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 irritationThe 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:
| |
8.2.Eye irritationaThe 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:
| |
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:
| |
8.4.Respiratory sensitisation | ADS | Testing on the product/mixture does not need to be conducted if:
|
8.5.Acute toxicity
| Testing on the product/mixture does not need to be conducted if:
| |
8.5.1.By oral route | ||
8.5.2.By inhalation | ||
8.5.3.By dermal route | ||
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:
| |
8.6.Information on dermal absorptionInformation 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:
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:
| |
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 humansSuitable 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
| ||
9.2.Further Ecotoxicological studiesFurther 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 environmentFurther 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 | |
10.3.Leaching behaviour | ADS | |
10.4.Testing for distribution and dissipation in the following: | ADS | |
10.4.1.Soil | ADS | |
10.4.2.Water and sediment | ADS | |
10.4.3.Air | 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: | ||
11.4.1.Air | ||
11.4.2.Water, including drinking water | ||
11.4.3.Soil | ||
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 | ||
12.2.Hazard pictogram | ||
12.3.Signal word | ||
12.4.Hazard statements | ||
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 SUMMARYThe key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed |
Information required to support the authorisation of a biocidal product is listed in the table below.
For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply.
This Annex sets out rules to be followed when the applicant proposes to adapt the data requirements set out in Annexes II and III in accordance with Article 6(2) and (3) or Article 21(1) and (2), without prejudice to the specific rules set out in Annex III on the use of the calculation methods for classification of mixtures to avoid testing on vertebrates.
The reasons for such adaptations to the data requirements must be clearly stated under the appropriate heading of the dossier referring to the specific rule(s) of this Annex.
Data shall be considered to be equivalent to data generated by the corresponding test methods if the following conditions are met:
adequacy of the data for the purpose of classification and labelling and risk assessment;
sufficient adequate and reliable documentation is provided to assess the equivalency of the study; and
the data are valid for the endpoint being investigated and the study is performed using an acceptable level of quality assurance.
Data shall be considered to be equivalent to data generated by the corresponding test methods if the following conditions are met:
adequacy of the data for the purpose of classification and labelling and risk assessment;
adequate and reliable coverage of the key parameters/endpoints foreseen to be investigated in the corresponding test methods;
exposure duration comparable to or longer than the corresponding test methods if exposure duration is a relevant parameter;
adequate and reliable documentation of the study is provided; and
the study is performed using a system of quality assurance.
As a general rule, in accordance with Article 7(3) of Regulation (EC) No 1272/2008, tests on humans shall not be performed for the purposes of this Regulation. However, existing historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data, biomonitoring studies, clinical studies and human volunteer studies performed in accordance with internationally accepted ethical standards shall be considered.
Data collected on humans shall not be used to lower the safety margins resulting from tests or studies on animals.
The strength of the data for a specific human health effect depends, among other things, on the type of analysis and the parameters covered, and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include:
the proper selection and characterisation of the exposed and control groups;
adequate characterisation of exposure;
sufficient length of follow-up for disease occurrence;
valid method for observing an effect;
proper consideration of bias and confounding factors; and
a reasonable statistical reliability to justify the conclusion.
In all cases adequate and reliable documentation shall be provided.
There may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or does not have a particular dangerous property, while the information from each single source alone is considered insufficient to support this notion. There may be sufficient weight of evidence from the use of positive results of newly developed test methods, not yet included in the relevant test methods or from an international test method recognised by the Commission as being equivalent, leading to the conclusion that a substance has a particular dangerous property. However, if the newly developed test method has been approved by the Commission, but has not yet been published, its results may be taken into account even where this leads to the conclusion that a substance does not have a particular dangerous property.
Where consideration of all the available data provides sufficient weight of evidence for the presence or absence of a particular dangerous property:
further testing on vertebrates for that property shall not be undertaken,
further testing not involving vertebrates may be omitted.
In all cases adequate and reliable documentation shall be provided.
Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence, but not the absence of a given dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:
the results are derived from a (Q)SAR model whose scientific validity has been established,
the substance falls within the applicability domain of the (Q)SAR model,
the results are adequate for the purpose of classification and labelling and risk assessment, and
adequate and reliable documentation of the applied method is provided.
The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide guidance on the use of (Q)SARs.
Results obtained from suitable in vitro methods may indicate the presence of a given dangerous property or may be important in relation to a mechanistic understanding, which may be important for the assessment. In this context, ‘suitable’ means sufficiently well-developed according to internationally agreed test development criteria.
Where such in vitro tests are positive, it is necessary to confirm the dangerous property by adequate in vivo tests. However, such confirmation may be waived if the following conditions are met:
results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles;
results are adequate for the purpose of classification and labelling and risk assessment; and
adequate and reliable documentation of the applied method is provided.
In the case of negative results, these exemptions do not apply. A confirmation test may be requested on a case-by-case basis.
Substances whose physico-chemical, toxicological and ecotoxicological properties are similar or follow a regular pattern as a result of structural similarity may be considered as a group or ‘category’ of substances. Application of the group concept requires that physico-chemical properties, human and animal health effects, and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). This avoids the need to test every substance for every endpoint.
The similarities may be based on:
a common functional group indicating the presence of dangerous properties;
common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals and indicates the presence of dangerous properties; or
a constant pattern in the changing of the potency of the properties across the category.
If the group concept is applied, substances shall be classified and labelled on this basis.
In all cases results shall:
be adequate for the purpose of classification and labelling and risk assessment,
have adequate and reliable coverage of the key parameters addressed in the corresponding test method, and
cover an exposure duration comparable to or longer than the corresponding test method if exposure duration is a relevant parameter.
In all cases, adequate and reliable documentation of the applied method shall be provided.
The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide guidance on technically and scientifically justified methodology for the grouping of substances.
Testing for a specific endpoint may be omitted if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion, or the radio-labelling of the substance required in certain studies may not be possible. The guidance given in the relevant test methods, more specifically on the technical limitations of a specific method, shall always be respected.
In that case, the following conditions shall be met:
An exposure assessment shall be performed, covering primary and secondary exposure under realistic worst case for all intended uses of the biocidal product that contains the active substance for which approval is applied, or of the biocidal product for which the authorisation is sought.
If a new exposure scenario is introduced at a later stage, during the product authorisation process, additional data shall be submitted to assess whether the justification for data adaptation still applies.
The reasons why the outcome of the exposure assessment justifies waiving of data requirements shall be clearly and transparently explained.
However, testing cannot be omitted for non-threshold effects. As a consequence, certain core data shall always be obligatory, e.g. genotoxicity testing.
If relevant, the Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide further guidance on the criteria established in accordance with Article 6(4) and Article 21(3).
These product-types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.
Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp.
Products used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs.
Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas and in other areas for professional activities.
Products used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil.
Products used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of construction materials.
Products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.
Products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function.
Products used to disinfect the materials and surfaces associated with the housing or transportation of animals.
Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals.
Products used to impregnate materials which may enter into contact with food.
Products used for the disinfection of drinking water for both humans and animals.
Unless otherwise stated these product-types include only products to prevent microbial and algal development.
Products used for the preservation of manufactured products, other than foodstuffs, feedingstuffs, cosmetics or medicinal products or medical devices by the control of microbial deterioration to ensure their shelf life.
Products used as preservatives for the storage or use of rodenticide, insecticide or other baits.
Products used for the preservation of films or coatings by the control of microbial deterioration or algal growth in order to protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, wall adhesives, binders, papers, art works.
Products used for the preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms, including insects.
This product-type includes both preventive and curative products.
Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products by the control of microbiological deterioration.
This product-type includes biocidal products which antagonise the settlement of micro-organisms on the surface of materials and therefore hamper or prevent the development of odour and/or offer other kinds of benefits.
Products used for the preservation of masonry, composite materials, or other construction materials other than wood by the control of microbiological, and algal attack.
Products used for the preservation of water or other liquids used in cooling and processing systems by the control of harmful organisms such as microbes, algae and mussels.
Products used for the disinfection of drinking water or of water for swimming pools are not included in this product-type.
Products used for the prevention or control of slime growth on materials, equipment and structures, used in industrial processes, e.g. on wood and paper pulp, porous sand strata in oil extraction.
Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials.
Products used for the control of mice, rats or other rodents, by means other than repulsion or attraction.
Products used for the control of birds, by means other than repulsion or attraction.
Products used for the control of molluscs, worms and invertebrates not covered by other product-types, by means other than repulsion or attraction.
Products used for the control of fish, by means other than repulsion or attraction.
Products used for the control of arthropods (e.g. insects, arachnids and crustaceans), by means other than repulsion or attraction.
Products used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds, fish, rodents), by repelling or attracting, including those that are used for human or veterinary hygiene either directly on the skin or indirectly in the environment of humans or animals.
Products used for the control of vertebrates other than those already covered by the other product-types of this main group, by means other than repulsion or attraction.
Products used to control the growth and settlement of fouling organisms (microbes and higher forms of plant or animal species) on vessels, aquaculture equipment or other structures used in water.
Products used for the disinfection and preservation of human or animal corpses, or parts thereof.
Correspondence with the criteria set out in Article 19(1)(b)
The subheadings ‘Effects on human and animal health’, ‘Effects on the Environment’, ‘Effects on Target Organisms’ and ‘Efficacy’ used in the Sections ‘Assessment’ and ‘Conclusions’ correspond to the four criteria set out in Article 19(1)(b) as follows:
‘Efficacy’ corresponds to criterion (i): ‘is sufficiently effective’.
‘Effects on target organisms’ corresponds to criterion (ii): ‘has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross resistance or unnecessary suffering and pain for vertebrates’.
‘Effects on human and animal health’ corresponds to criterion (iii): ‘has no immediate or delayed unacceptable effects itself, or as a result of its residues, on human health, including that of vulnerable groups(4), or animal health, directly or through drinking water, food, feed, air, or through other indirect effects’.
‘Effects on the environment’ corresponds to criterion iv: ‘has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations:
its fate and distribution in the environment,
contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation,
its impact on non-target organisms,
its impact on biodiversity and the ecosystem’.
The identification of the adverse effects which a biocidal product has an inherent capacity to cause.
The estimate of the relationship between the dose, or level of exposure, of an active substance or substance of concern in a biocidal product and the incidence and severity of an effect.
The determination of the emissions, pathways and rates of movement of an active substance or a substance of concern in a biocidal product and its transformation or degradation in order to estimate the concentration/doses to which human populations, animals or environmental compartments are or may be exposed.
The estimation of the incidence and severity of the adverse effects likely to occur in a human population, animals or environmental compartments due to actual or predicted exposure to any active substance or substance of concern in a biocidal product. This may include ‘risk estimation’, i.e. the quantification of that likelihood.
Water, including sediment, air, soil, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms.
take into consideration other relevant technical or scientific information which is reasonably available to them with regard to the properties of the biocidal product, its components, metabolites, or residues;
evaluate, where relevant, justifications submitted by the applicant for not supplying certain data.
the hazards due to the physico-chemical properties,
the risk to humans and animals,
the risk to the environment,
the measures necessary to protect humans, animals and the environment, both during the proposed normal use of the biocidal product and in a realistic worst-case situation.
acute toxicity,
irritation,
corrosivity,
sensitisation,
repeated dose toxicity,
mutagenicity,
carcinogenicity,
reproductive toxicity,
neurotoxicity,
immunotoxicity,
disruption of the endocrine system,
any other special properties of the active substance or substance of concern,
other effects due to physico-chemical properties.
professional users,
non-professional users,
humans exposed directly or indirectly via the environment.
In considering these populations, particular attention should be given to the need to protect vulnerable groups within these populations.
adequately measured exposure data,
the form in which the biocidal product is marketed,
the type of biocidal product,
the application method and application rate,
the physico-chemical properties of the biocidal product,
the likely routes of exposure and potential for absorption,
the frequency and duration of exposure,
maximum residue levels,
the type and size of specific exposed populations, where such information is available.
These models shall:
make a best possible estimation of all relevant processes taking into account realistic parameters and assumptions,
be subjected to an analysis taking into account possible elements of uncertainty,
be reliably validated with measurements carried out under circumstances relevant for the use of the model,
be relevant to the conditions in the area of use.
Relevant monitoring data from substances with analogous use and exposure patterns or analogous properties shall also be considered.
Assessment factors account for the extrapolation from animal toxicity to the exposed human population. The setting of an overall assessment factor considers the degree of uncertainty in inter-species and intra-species extrapolation. In the absence of suitable chemical-specific data, a default assessment factor of 100 is applied to the relevant reference value. Additional elements can also be considered for assessment factors, including toxicokinetics and toxicodynamics, the nature and severity of the effect, human (sub-)populations, exposure deviations between study results and human exposure with regard to frequency and duration, study duration extrapolation (e.g. sub-chronic to chronic), dose-response relationship and the overall quality of the toxicity data package.
adequately measured exposure data,
the form in which the product is marketed,
the type of biocidal product,
the application method and application rate,
the physico-chemical properties,
breakdown/transformation products,
likely pathways to environmental compartments and potential for adsorption/desorption and degradation,
the frequency and duration of exposure,
long range environmental transportation.
ISO, CEN or other international standard method
national standard method
industry standard method (if accepted by the evaluating body)
individual producer standard method (if accepted by the evaluating body)
data from the actual development of the biocidal product (if accepted by the evaluating body).
that the biocidal product complies with the criteria;
that, subject to specific conditions/restrictions, the biocidal product can comply with the criteria;
that it is not possible, without additional data, to establish if the biocidal product complies with the criteria;
that the biocidal product does not comply with the criteria.
In the determination of the PEC, the most appropriate model should be used taking into account the environmental fate and behaviour of the biocidal product.
Directive 2000/60/EC,
Directive 2006/118/EC,
Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy(5),
Directive 2008/105/EC, or
international agreements on the protection of river systems or marine waters from pollution.
the maximum permissible concentration laid down by Directive 98/83/EC, or
the maximum concentration as laid down following the procedure for approving the active substance under this Regulation, on the basis of appropriate data, in particular toxicological data,
unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.
exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking water, the values fixed by:
Directive 2000/60/EC,
Directive 98/83/EC, or
has an impact deemed unacceptable on non-target organisms,
unless it is scientifically demonstrated that under relevant field conditions this concentration is not exceeded.
the PEC/PNEC is above 1, or
the concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products, has an unacceptable impact on non-target species, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.
death is synchronous with the extinction of consciousness, or
death occurs immediately, or
vital functions are reduced gradually without signs of obvious suffering.
For repellent products, the intended effect shall be obtained without unnecessary suffering and pain for the target vertebrate.
The evaluating body shall, on the basis of the evaluation carried out in accordance with the principles set down in this Annex, come to a conclusion as to whether or not it is established that the biocidal product complies with the criteria laid down under point (b) of Article 19(1).
Directive 98/8/EC | This Regulation |
---|---|
— | Article 1 |
Article 1 | Article 2 |
Article 2 | Article 3 |
Article 10 | Article 4 |
Article 10 | Article 5 |
— | Article 6 |
Article 11(1)(a) | 6(1) |
Article 11(1)(a)(i) and (ii) | 6(2) |
— | 6(3) |
— | 6(4) |
— | Article 7 |
Article 11(1)(a) | 7(1) |
— | 7(2) |
— | 7(3) |
— | 7(4) |
— | 7(5) |
— | 7(6) |
— | Article 8 |
Article 11(2), first subparagraph | 8(1) |
Article 11(2), second subparagraph | 8(2) |
Article 10(1), first subparagraph | 8(3) |
— | 8(4) |
— | Article 9 |
11(4) | 9(1) |
— | 9(2) |
— | Article 10 |
Article 33 | Article 11 |
Article 10(4) | Article 12 |
— | 12(1) |
— | 12(2) |
— | 12(3) |
— | Article 13 |
— | Article 14 |
— | Article 15 |
— | Article 16 |
— | Article 17 |
Article 3(1) | 17(1) |
Article 8(1) | 17(2) |
— | 17(3) |
Article 3(6) | 17(4) |
Article 3(7) | 17(5) |
— | 17(6) |
— | Article 18 |
— | Article 19 |
Article 5(1) | 19(1) |
Article 5(1)(b) | 19(2) |
— | 19(3) |
Article 5(2) | 19(4) |
— | 19(5) |
Article 2(1)(j) | 19(6) |
— | 19(7) |
— | 19(8) |
— | 19(9) |
— | Article 20 |
Article 8(2) | 20(1) |
Article 8(12) | 20(2) |
— | 20(3) |
— | Article 21 |
— | Article 22 |
Article 5(3) | 22(1) |
— | 22(2) |
— | Article 23 |
— | 23(1) |
Article 10(5)(i) | 23(2) |
— | 23(3) |
— | 23(4) |
— | 23(5) |
— | 23(6) |
Article 33 | Article 24 |
— | Article 25 |
— | Article 26 |
— | Article 27 |
— | Article 28 |
— | Article 29 |
— | Article 30 |
— | Article 31 |
Article 4 | Article 32 |
— | Article 33 |
— | Article 34 |
— | Article 35 |
Article 4(4) | Article 36 |
— | Article 37 |
— | Article 38 |
— | Article 39 |
— | Article 40 |
— | Article 41 |
— | Article 42 |
— | Article 43 |
— | Article 44 |
— | Article 45 |
— | Article 46 |
— | Article 47 |
Article 7 | Article 48 |
Article 7 | Article 49 |
Article 7 | Article 50 |
— | Article 51 |
— | Article 52 |
— | Article 53 |
— | Article 54 |
Article 15 | Article 55 |
Article 17 | Article 56 |
— | Article 57 |
— | Article 58 |
Article 12 | Article 59 |
— | Article 60 |
— | 60(1) |
Article 12(1)(c)(ii) and (1)(b) and (1)(d)(ii) | 60(2) |
Article 12(2)(c)(i) and (ii) | 60(3) |
— | Article 61 |
— | Article 62 |
— | Article 63 |
Article 13(2) | 63(1) |
— | 63(2) |
— | 63(3) |
Article 13(1) | Article 64 |
— | Article 65 |
Article 24 | 65(1) |
— | 65(2) |
Article 24 | 65(3) |
— | 65(4) |
— | Article 66 |
— | 66(1) |
— | 66(2) |
— | 66(3) |
Article 19(1) | 66(4) |
— | Article 67 |
— | Article 68 |
— | Article 69 |
Article 20(1) and 20(2) | Article 69(1) |
Article 20(3) | Article 69(2) |
Article 20(6) | Article 69(2) |
Article 21, second subparagraph | Article 70 |
— | Article 71 |
— | Article 72 |
Article 22(1), first and second subparagraphs | 72(1) |
Article 22(1), third subparagraph | 72(2) |
Article 22(2) | 72(3) |
— | Article 73 |
— | Article 74 |
— | Article 75 |
— | Article 76 |
— | Article 77 |
— | Article 78 |
— | Article 79 |
— | Article 80 |
— | 80(1) |
Article 25 | 80(2) |
— | 80(3) |
Article 26 | Article 81 |
Article 28 | Article 82 |
— | Article 83 |
— | Article 84 |
Article 29 | Article 85 |
— | Article 86 |
— | Article 87 |
Article 32 | Article 88 |
— | Article 89 |
— | Article 90 |
— | Article 91 |
— | Article 92 |
— | Article 93 |
— | Article 94 |
— | Article 95 |
— | Article 96 |
— | Article 97 |
Annex IA | Annex I |
Annex II A, III A and IV A | Annex II |
Annex II B, III B and IV B | Annex III |
— | Annex IV |
Annex V | Annex V |
Annex VI | Annex VI |
See definition of vulnerable groups in Article 3.