Annex III

02012R0528-20210610 → 02012R0528-20220415

ANNEX III INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS 1. This Annex sets out the information requirements that shall be included in the dossier for the biocidal product accompanying an application for the approval of an active substance in accordance with point (b) of Article 6(1) and the dossier accompanying an application for the authorisation of a biocidal product in accordance with point (a) of Article 20(1). 2. The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS). The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all biocidal products. 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. However, the information may be not sufficient or adequate to determine whether a non-active substance contained in a biocidal product has hazardous properties and the evaluating body may conclude that further data are required. 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 shall initiate a pre-submission consultation. consultation with the prospective evaluating body. In addition to the obligation set out in Article 62(2), applicants the applicant 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. The applicant shall document such pre-submission consultations and their outcomes and shall include the relevant documents in the application. 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. 3. A detailed and full description of studies conducted and of the methods used shall be included. It is important to ensure that the data available is relevant and is of sufficient quality to fulfil the requirements. 4. The formats made available by the Agency shall be used for submission of the dossiers. In addition, IUCLID shall be used for those parts of the dossiers to which IUCLID applies. Formats and further guidance on data requirements and dossier preparation are available on the Agency homepage. 5. Tests submitted for the purpose of authorisation shall be conducted according to in accordance with the methods described in Commission Regulation (EC) No 440/2008. 440/2008, or any revised version of these methods not yet included in that Regulation. However, if a method is inappropriate or not described, described in Commission Regulation (EC) No 440/2008, Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1). other methods shall be used which are scientifically appropriate, whenever possible internationally recognised, appropriate and their appropriateness must shall be justified in the application. When test methods are applied to nanomaterials, nano-materials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and, and where applicable, of the technical adaptations/adjustments adaptations or adjustments that have been made in order to respond to the specific characteristics of these materials. 6. Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 2010/63/EU and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC or other international standards recognised as being equivalent by the Commission or the Agency. Tests on physico-chemical properties and safety-relevant substance data should be performed at least according to international standards. 7. Where testing is done, a detailed quantitative and qualitative description (specification) of the product used for each test and its impurities must be provided. 8. Where test data exist that have been generated before 17 July 2012 by methods other than those laid down in Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct new tests according to the Regulation (EC) No 440/2008 must be decided by the competent authority of the Member State, on a case-by-case basis, taking into account, among other factors, the need to avoid unnecessary testing. 9. New tests involving vertebrates shall be conducted as the last available option to comply with the data requirements set out in this Annex when all the other data sources have been exhausted. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall also be avoided. TITLE 1 CHEMICAL PRODUCTS Core data set and additional data set for chemical products 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. Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties. 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 column 1 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. … 731 unchanged words … 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 regarding the biocidal properties conferred to the article 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. side-effects on beneficial and other non-target organisms or on objects and material to be protected 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 irritation The assessment shall comprise the following tiers: (a) assessment of this endpoint shall be carried out according to the sequential available human, animal and non-animal data; (b) skin corrosion, in vitro testing; (c) skin irritation, in vitro testing; (d) skin corrosion or irritation, in vivo testing strategy for dermal irritation and corrosion set out in Testing of 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 product or mixture does not need to be conducted if: there are sufficient valid data available on each component of the components in the product or mixture sufficient to allow its classification of the mixture according to the rules laid down in Directive 1999/45/EC and accordance with Regulation (EC) No 1272/2008 (CLP), 1272/2008, and synergistic effects between any of the components are not expected expected, the product or mixture is a strong acid (pH≤ 2,0) or base (pH≥ 11,5), the product or mixture is spontaneously flammable in air or in contact with water or moisture at room temperature, the product or mixture meets the classification criteria for acute toxicity category 1 by the dermal route, or an acute toxicity study by the dermal route provides conclusive evidence on skin corrosion or irritation adequate for classification. If results from one of the two studies listed in points (b) or (c) in column 1 of this row already allow conclusive decision on the classification of product or mixture or on the absence of skin irritation potential, the second study does not need to be conducted An in vivo study for skin corrosion or irritation shall be considered only if the in vitro studies listed in points (b) and (c) in column 1 of this row are not applicable, or the results of these studies are not adequate for classification and risk assessment and the calculation method or bridging principles laid down in Regulation (EC) No 1272/2008 are not applicable In vivo studies for skin corrosion or irritation that were carried out or initiated before 15 April 2022 shall be considered appropriate to address this information requirement 8.2. Eye Serious eye damage or eye irritation The assessment shall comprise the following tiers: (a) assessment of this endpoint shall be carried out according to the sequential available human, animal and non-animal data; (b) serious eye damage or eye irritation, in vitro testing; (c) serious eye damage or eye irritation, in vivo 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 product or mixture does not need to be conducted if: there are sufficient valid data available on each component of the components in the product or mixture to allow its classification of the mixture according to the rules laid down in Directive 1999/45/ECand accordance with Regulation (EC) No 1272/2008 (CLP), 1272/2008, and synergistic effects between any of the components are not expected expected, the product or mixture is a strong acid (pH≤ 2,0) or base (pH≥ 11,5), the product or mixture is spontaneously flammable in air or in contact with water or moisture at room temperature, or the product or mixture meets the classification criteria for skin corrosion leading to its classification as serious eye damage category 1 If results from a first in vitro study do not allow a conclusive decision on the classification of the product or mixture or on the absence of eye irritation potential (an)other(s) in vitro study(ies) for this endpoint shall be considered An in vivo study for serious eye damage or eye irritation shall be considered only if the in vitro study(ies) under point (b) in column 1 of this row are not applicable, or the results obtained from these studies are not adequate for classification and risk assessment and the calculation method or bridging principles laid down in Regulation (EC) No 1272/2008 are not applicable In vivo studies for serious eye damage or eye irritation that were carried out or initiated before 15 April 2022 shall be considered appropriate to address this information requirement 8.3. Skin sensitisation The information shall allow to conclude whether the substance is a skin sensitiser and whether it can be presumed to have the potential to produce significant sensitisation in humans (Category 1A). The information should be sufficient to perform a risk assessment of this endpoint where required The assessment shall comprise the following consecutive steps: 1. an tiers: (a) assessment of the available human, animal and alternative data 2. non-animal data; (b) skin sensitisation, in vitro testing. Information from in vitro or in chemico test method(s) conducted in accordance with point 5 of the introductory part of this Annex and addressing each of the following key events of skin sensitisation: (i) molecular interaction with skin proteins; (ii) inflammatory response in keratinocytes; (iii) activation of dendritic cells. (c) skin sensitisation in vivo testing 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. Another skin sensitisation test may only be used in exceptional circumstances. If another skin sensitisation test is used used, scientific justification shall be provided provided. Testing on the product/mixture product or mixture does not need to be conducted if: there are sufficient valid data available on each component of the components in the product or mixture to allow its classification of the mixture according to the rules laid down in Directive 1999/45/EC and accordance with Regulation (EC) No 1272/2008 (CLP), 1272/2008, and synergistic effects between any of the components are not expected expected, the available information indicates that the product or mixture should be classified for skin sensitisation or corrosivity; skin corrosion, the product or the substance mixture is a strong acid (pH < (pH≤ 2,0) or base (pH > 11,5) (pH≥ 11,5), or the product or mixture is spontaneously flammable in air or in contact with water or moisture at room temperature. In vitro tests do not need to be conducted if: an in vivo study referred to in point (c) in column 1 of this row is available, or the available in vitro or in chemico test methods are not applicable for the product or mixture or the results obtained from these studies are not adequate for classification and risk assessment. If information from test method(s) addressing one or two of the key events described in point (b) in column 1 of this row already allows for classification of the substance and risk assessment, studies addressing the other key event(s) do not need to be conducted An in vivo study for skin sensitisation shall be considered only if in vitro or in chemico studies referred to in point (b) in column 1 of this row are not applicable, or the results obtained from these studies are not adequate for classification and risk assessment and the calculation method or bridging principles laid down in Regulation (EC) No 1272/2008 are not applicable In vivo studies for skin sensitisation that were carried out or initiated before 15 April 2022 shall be considered appropriate to address this information requirement 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 8.5.1. 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: 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: (a) non-active substance(s) (i.e. substance(s) of concern), or concern); and (b) 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 Tests listed in Section 8 of the table in Title 1 of 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 if insufficient data are available and cannot be inferred through read-across, in silico or other accepted non-testing approaches Testing on the product/mixture product or mixture does not need to be conducted if: if all of the following conditions are met: there are valid data available on each of the components in the mixture to allow classification of the mixture according to in accordance with the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP) 1272/2008, a conclusion can be made whether the biocidal product can be considered as having endocrine disrupting properties, synergistic effects between any of the components are not expected 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 Available ecotoxicological data relating to to: (a) non-active substance(s) (i.e. substance(s) of concern); (b) a mixture that a substance(s) of concern is a component of Tests listed in Section 9 of Title 1 of Annex II shall be carried out for the ecotoxicity substance(s) of concern or a mixture that a substance(s) of concern is a component of if insufficient data are available and cannot be inferred through read-across, in silico or other accepted non-testing approaches Testing on the biocidal product which is sufficient to enable a decision or mixture does not need to be made concerning conducted if all the classification of the product is required Where following conditions are met: there are valid data available on each of the components in the mixture and to allow classification of the mixture in accordance with the rules laid down in Regulation (EC) No 1272/2008, a conclusion can be made whether the biocidal product can be considered as having endocrine disrupting properties, 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 … 643 unchanged words … down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply. 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 column 1 1. APPLICANT 1.1. Name and address 1.2. Contact person 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 g/l, % w/w (v/v)) (v/v), cfu/g, cfu/l or IU/mg or any other appropriate unit) and qualitative information on the constitution, composition and function of the biocidal product, e.g. micro-organism, active substance(s) and product non-active substances and any other relevant components. 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 2.5. Where the biocidal product contains an active substance that has been manufactured in locations or according to processes or from starting materials other than those of the active substance evaluated for the purpose of approval pursuant to Article 9 of this Regulation, evidence has to be provided that technical equivalence has been established in accordance with Article 54 of this Regulation or has been established, following an evaluation having started before 1 September 2013, by a competent authority designated in accordance with Article 26 of Directive 98/8/EC 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 3.4. Relative density 3.5. Storage stability, stability and shelf-life 3.5.1. Effects of light 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 3.6.1. Wettability 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 3.6.6. Persistent foaming 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 3.6.8. Spraying patterns – aerosols 3.6.9. 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 3.8. Surface tension 3.9. Viscosity 4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS 4.1. Explosives 4.2. Flammable gases aerosols 4.3. Flammable aerosols liquids 4.4. Oxidising gases 4.5. Gases under pressure 4.6. Flammable liquids 4.7. Flammable solids 4.8. 4.5. Oxidising liquids 4.9. 4.6. Oxidising solids 4.10. Organic peroxides 4.11. 4.7. Corrosive to metals 4.12. 4.8. Other physical indications of hazard 4.12.1. 4.8.1. Auto-ignition temperatures of products (liquids and gases) 4.12.2. 4.8.2. Relative self-ignition temperature for solids 4.12.3. 4.8.3. 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 … 1,062 unchanged words … 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 and/or mobility 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 11.3.2. Others 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