Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance

• 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 shall initiate a pre-submission consultation with the prospective evaluating body. In addition to the obligation set out in Article 62(2), 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 in accordance with the methods described in Commission Regulation (EC) No 440/2008, or any revised version of these methods not yet included in that Regulation.

• However, if a method is inappropriate or not described in Commission Regulation (EC) No 440/2008, ([^E0059]) other methods shall be used which are scientifically appropriate and their appropriateness shall be justified in the application.

• When test methods are applied to nano-materials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and where applicable, of the technical 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.

Column 1 Information required:	Column 2 All data is CDS unless indicated as ADS	Column 3 Specific rules for adaptation from column 1
1. APPLICANT	1. APPLICANT	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. IDENTITY OF THE BIOCIDAL PRODUCT	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
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. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES	3. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES	3. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES
3.1.  Appearance (at 20 °C and 101,3 kPa)	3.1.  Appearance (at 20 °C and 101,3 kPa)	3.1.  Appearance (at 20 °C and 101,3 kPa)
3.1.1.  Physical state (at 20 °C and 101,3 kPa)
3.1.2.  Colour (at 20 °C and 101,3 kPa)
3.1.3.  Odour (at 20 °C and 101,3 kPa)
3.2.  Acidity/alkalinity The test is applicable when the pH of the biocidal product or its dispersion in water (1 %) is outside the pH range 4-10
3.3.  Relative density (liquids) and bulk, tap density (solids)
3.4.  Storage stability, stability and shelf-life	3.4.  Storage stability, stability and shelf-life	3.4.  Storage stability, stability and shelf-life
3.4.1.  Storage stability tests	3.4.1.  Storage stability tests	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.  Effects on content of the active substance and technical characteristics of the biocidal product	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.  Technical characteristics of the biocidal product	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.  Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised	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. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS	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.  Additional physical indications of hazard	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. METHODS OF DETECTION AND IDENTIFICATION	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. EFFECTIVENESS AGAINST TARGET ORGANISMS	6. EFFECTIVENESS AGAINST TARGET ORGANISMS
6.1.  Function, e.g. fungicide, rodenticide, insecticide, bactericide Mode of control e.g. attracting, killing, inhibiting
6.2.  Representative organism(s) to be controlled and products, organisms or objects to be protected
6.3.  Effects on representative target organisms
6.4.  Likely concentration at which the active substance will be used
6.5.  Mode of action (including time delay)
6.6.  The proposed claims for the product and, where 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.  Any known limitations on efficacy	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 on non-target organisms or on objects and material to be protected
6.9.  Summary and evaluation
7. INTENDED USES AND EXPOSURE	7. INTENDED USES AND EXPOSURE	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.  Exposure data in conformity with Annex VI to this Regulation	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. TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS	8. TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS
8.1.  Skin corrosion or irritation The assessment shall comprise the following tiers: (a) assessment of the 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		Testing of the product or mixture does not need to be conducted if: — there are sufficient valid data on each component of the product or mixture to allow its classification in accordance with Regulation (EC) No 1272/2008, and synergistic effects between any of the components are not expected, — 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.  Serious eye damage or eye irritation The assessment shall comprise the following tiers: (a) assessment of the 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		Testing on the product or mixture does not need to be conducted if: — there are sufficient valid data available on each component of the product or mixture to allow its classification in accordance with Regulation (EC) No 1272/2008, and synergistic effects between any of the components are not expected, — 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 where required The assessment shall comprise the following tiers: (a) assessment of the available human, animal and 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. The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing. Another skin sensitisation test may only be used in exceptional circumstances. If another skin sensitisation test is used, scientific justification shall be provided.		Testing on the product or mixture does not need to be conducted if: — there are sufficient valid data available on each component of the product or mixture to allow its classification in accordance with Regulation (EC) No 1272/2008, and synergistic effects between any of the components are not expected, — the available information indicates that the product or mixture should be classified for skin sensitisation or skin corrosion, — the product or mixture is a strong acid (pH≤ 2,0) or base (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); and (b) a mixture that a substance(s) of concern is a component of 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 or mixture does not need to be conducted 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 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
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. ECOTOXICOLOGICAL STUDIES	9. ECOTOXICOLOGICAL STUDIES
9.1.  Available ecotoxicological data relating 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 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 or mixture does not need to be conducted if all the following conditions are met: — there are valid data available on each of the components in the mixture to allow classification of the mixture in accordance with the rules laid down in Regulation (EC) No 1272/2008, — 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
9.2.  Further Ecotoxicological studies Further studies chosen from among the endpoints referred to in Section 9 of Annex II for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product
9.3.  Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk	ADS	Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment
9.4.  If the biocidal product is in the form of bait or granules the following studies may be required:	9.4.  If the biocidal product is in the form of bait or granules the following studies may be required:	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	10. ENVIRONMENTAL FATE AND BEHAVIOUR	10. ENVIRONMENTAL FATE AND BEHAVIOUR
The test requirements below are applicable only to the relevant components of the biocidal product
10.1.  Foreseeable routes of entry into the environment on the basis of the use envisaged
10.2.  Further studies on fate and behaviour in the environment Further studies chosen from among the endpoints referred to in Section 10 of Annex II for relevant components of the biocidal product or the biocidal product itself may be required. For products that are used outside, with direct emission to soil, water or surfaces, the components in the product may influence the fate and behaviour (and ecotoxicity) of the active substance. Data are required unless it is scientifically justified that the fate of the components in the product is covered by the data provided for the active substance and other identified substances of concern	ADS
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. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT	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.  Possibility of destruction or decontamination following release in or on the following:	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	12. CLASSIFICATION, LABELLING, AND PACKAGING	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 SUMMARY The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed

Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties.

TITLE 2

MICRO-ORGANISMS

Core data set and additional data set

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.

Column 1 Information required:	Column 2 All data is CDS unless indicated as ADS	Column 3 Specific rules for adaptation from column 1
1. APPLICANT	1. APPLICANT	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. IDENTITY OF THE BIOCIDAL PRODUCTS	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, % w/w (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 non-active substances and any other relevant components All relevant information on individual ingredients and the final composition of the biocidal product shall be given
2.4.  Formulation type and nature of the biocidal product
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. BIOLOGICAL, PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT	3. BIOLOGICAL, PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT
3.1.  Biological properties of the micro-organism in the biocidal product
3.2.  Appearance (at 20 °C and 101,3 kPa)	3.2.  Appearance (at 20 °C and 101,3 kPa)	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.  Storage stability, stability and shelf-life	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.  Technical characteristics of the biocidal product	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.  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.  Physical, chemical and biological compatibility with other products including biocidal products with which its use is to be authorised or registered	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. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS	4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS
4.1.  Explosives
4.2.  Flammable aerosols
4.3.  Flammable liquids
4.4.  Flammable solids
4.5.  Oxidising liquids
4.6.  Oxidising solids
4.7.  Corrosive to metals
4.8.  Other physical indications of hazard
4.8.1.  Auto-ignition temperatures of products (liquids and gases)
4.8.2.  Relative self-ignition temperature for solids
4.8.3.  Dust explosion hazard
5. METHODS OF DETECTION AND IDENTIFICATION	5. METHODS OF DETECTION AND IDENTIFICATION	5. METHODS OF DETECTION AND IDENTIFICATION
5.1.  Analytical method for determining the concentration of the micro-organism(s) and substances of concern in the biocidal product
5.2.  Analytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance nor the article treated with it does not come into contact with food-producing animals, food of plant and animal origin or feeding stuffs)	ADS
6. EFFECTIVENESS AGAINST TARGET ORGANISM	6. EFFECTIVENESS AGAINST TARGET ORGANISM	6. EFFECTIVENESS AGAINST TARGET ORGANISM
6.1.  Function and mode of control
6.2.  Representative pest organism(s) to be controlled and products, organisms or objects to be protected
6.3.  Effects on representative target organisms
6.4.  Likely concentration at which micro-organism will be used
6.5.  Mode of action
6.6.  The proposed label claims for the product
6.7.  Efficacy data to support these claims, including any available standard protocols, laboratory tests, or field trials used including performance standards, where appropriate and relevant
6.8.  Any other known limitations on efficacy including resistance	6.8.  Any other known limitations on efficacy including resistance	6.8.  Any other known limitations on efficacy including resistance
6.8.1.  Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies
6.8.2.  Observations on undesirable or unintended side effects
7. INTENDED USES AND EXPOSURE	7. INTENDED USES AND EXPOSURE	7. INTENDED USES AND EXPOSURE
7.1.  Field of use envisaged
7.2.  Product-type
7.3.  Detailed description of intended use
7.4.  User e.g. industrial, trained professional, professional or general public (non-professional)
7.5.  Method of application and a description of this method
7.6.  Application rate and if appropriate the final concentration of the biocidal product or the micro-organism active substance in a treated article or the system in which the product is to be used (e.g. in the application device or bait)
7.7.  Number and timing of applications and duration of protection Any particular information relating to the geographical location or climatic variations including necessary waiting periods for re-entry or necessary withdrawal period or other precautions to protect human health, animal health and the environment
7.8.  Proposed instructions for use
7.9.  Exposure data	7.9.  Exposure data	7.9.  Exposure data
7.9.1.  Information on human exposure associated with the proposed/expected uses and disposal
7.9.2.  Information on environmental exposure associated with the proposed/expected uses and disposal
8. TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS		Testing on the product/mixture does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP) and synergistic effects between any of the components are not expected
8.1.  Skin corrosion or irritation
8.2.  Eye irritation
8.3.  Skin sensitisation
8.4.  Respiratory sensitisation	ADS
8.5.  Acute toxicity — Classification using the tiered approach to classification of mixtures for acute toxicity in Regulation (EC) No 1272/2008 is the default approach
8.5.1.  Oral
8.5.2.  Inhalation
8.5.3.  Dermal
8.5.4.  Additional acute toxicity studies
8.6.  Information on dermal absorption if required
8.7.  Available toxicological data relating to: — non-active substance(s) (i.e. substance(s) of concern), or — a mixture that a substance(s) of concern is a component of — If insufficient data are available for a non-active substance(s) and cannot be inferred through read-across or other accepted non-testing approaches, targeted test(s) described in Annex II, shall be carried out for the substance(s) of concern or a mixture that a substance(s) of concern is a component of		Testing on the product/mixture does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected
8.8.  Supplementary studies for combinations of biocidal products For biocidal products that are intended to be authorised for use with other biocidal products, the risks to humans, animals and the environment arising from the use of these product combinations shall be assessed. As an alternative to acute toxicity studies, calculations can be used. In some cases, for example where there are no valid data available of the kind set out in column 3, this may require a limited number of acute toxicity studies to be carried using combinations of the products		Testing on the mixture of products does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected
8.9.  Residues in or on treated articles, food and feedingstuffs	ADS
9. ECOTOXICOLOGICAL STUDIES	9. ECOTOXICOLOGICAL STUDIES	9. ECOTOXICOLOGICAL STUDIES
9.1.  Information relating to the ecotoxicity of the biocidal product which is sufficient to enable a decision to be made concerning the classification of the product is required — Where there are valid data available on each of the components in the mixture and synergistic effects between any of the components are not expected, classification of the mixture can be made according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP) — Where valid data on the components are not available or where synergistic effects may be expected then testing of components and/or the biocidal product itself may be necessary
9.2.  Further ecotoxicological studies Further studies chosen from among the endpoints referred to in Section 8 of Annex II ‘Micro-organisms’ for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product
9.3.  Effects on any other specific non-target organisms (flora and fauna) believed to be at risk	ADS	Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment
9.4.  If the biocidal product is in the form of bait or granules	ADS
9.4.1.  Supervised trials to assess risks to non-target organisms under field conditions	ADS
9.4.2.  Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought to be at risk	ADS
9.5.  Secondary ecological effect e.g. when a large proportion of a specific habitat type is treated	ADS
10. ENVIRONMENTAL FATE AND BEHAVIOUR	10. ENVIRONMENTAL FATE AND BEHAVIOUR	10. ENVIRONMENTAL FATE AND BEHAVIOUR
10.1.  Foreseeable routes of entry into the environment on the basis of the use envisaged
10.2.  Further studies on fate and behaviour in the environment Where relevant, all the information required in Section 9 of Annex II ‘Micro-organisms’ may be required for the product For products that are used outside, with direct emission to soil, water or surfaces, the components in the product may influence the fate and behaviour (and ecotoxicity) of the active substance. Data are required unless it is scientifically justified that the fate of the components in the product is covered by the data provided for the active substance and other identified substances of concern	ADS
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. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT	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.  Procedures for destruction or decontamination of the biocidal product and its packaging	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	12. CLASSIFICATION, LABELLING AND PACKAGING	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

ANNEX IV

GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS

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.

1. TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY

1.1.   Use of existing data

• 1.1.1. Data on physical-chemical properties from experiments not carried out according to GLP or the relevant test methods.

Data shall be considered to be equivalent to data generated by the corresponding test methods if the following conditions are met:

• (1) adequacy of the data for the purpose of classification and labelling and risk assessment;

• (2) sufficient adequate and reliable documentation is provided to assess the equivalency of the study; and

• (3) the data are valid for the endpoint being investigated and the study is performed using an acceptable level of quality assurance.

• 1.1.2. Data on human health and environmental properties from experiments not carried out according to GLP or the relevant test methods.

Data shall be considered to be equivalent to data generated by the corresponding test methods if the following conditions are met:

• (1) adequacy of the data for the purpose of classification and labelling and risk assessment;

• (2) adequate and reliable coverage of the key parameters/endpoints foreseen to be investigated in the corresponding test methods;

• (3) exposure duration comparable to or longer than the corresponding test methods if exposure duration is a relevant parameter;

• (4) adequate and reliable documentation of the study is provided; and

• (5) the study is performed using a system of quality assurance.

• 1.1.3. Historical human data

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:

• (1) the proper selection and characterisation of the exposed and control groups;

• (2) adequate characterisation of exposure;

• (3) sufficient length of follow-up for disease occurrence;

• (4) valid method for observing an effect;

• (5) proper consideration of bias and confounding factors; and

• (6) a reasonable statistical reliability to justify the conclusion.

In all cases adequate and reliable documentation shall be provided.

1.2.   Weight of evidence

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.

1.3.   Qualitative or Quantitative structure-activity relationship ((Q)SAR)

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.

1.4.   In vitro methods

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:

• (1) results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles;

• (2) results are adequate for the purpose of classification and labelling and risk assessment; and

• (3) 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.

1.5.   Grouping of substances and read-across approach

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:

• (1) a common functional group indicating the presence of dangerous properties;

• (2) 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

• (3) 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.

2. TESTING IS TECHNICALLY NOT POSSIBLE

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.

3. PRODUCT-TAILORED EXPOSURE-DRIVEN TESTING

• 3.1. Testing in accordance with some endpoints in Sections 8 and 9 of Annexes II and III, notwithstanding Article 6(2), may be omitted based on exposure considerations, where exposure data in accordance with Annex II or III are available.

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).

• 3.2. In all cases, adequate justification and documentation shall be provided. The justification shall be based on an exposure assessment, in accordance with the relevant Technical Notes for Guidance where available.

ANNEX V

BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)

MAIN GROUP 1:   Disinfectants

These product-types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.

Product-type 1:   Human hygiene

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.

Product-type 2:   Disinfectants and algaecides not intended for direct application to humans or animals

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.

Product-type 3:   Veterinary hygiene

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.

Product-type 4:   Food and feed area

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 be incorporated into materials which may enter into contact with food.

Product-type 5:   Drinking water

Products used for the disinfection of drinking water for both humans and animals.

MAIN GROUP 2:   Preservatives

Unless otherwise stated these product-types include only products to prevent microbial and algal development.

Product-type 6:   Preservatives for products during storage

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.

Product-type 7:   Film preservatives

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.

Product-type 8:   Wood preservatives

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.

Product-type 9:   Fibre, leather, rubber and polymerised materials preservatives

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.

Product-type 10:   Construction material preservatives

Products used for the preservation of masonry, composite materials, or other construction materials other than wood by the control of microbiological, and algal attack.

Product-type 11:   Preservatives for liquid-cooling and processing systems

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.

Product-type 12:   Slimicides

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.

Product-type 13:   Working or cutting fluid preservatives

Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials.

MAIN GROUP 3:   Pest control

Product-type 14:   Rodenticides

Products used for the control of mice, rats or other rodents, by means other than repulsion or attraction.

Product-type 15:   Avicides

Products used for the control of birds, by means other than repulsion or attraction.

Product-type 16:   Molluscicides, vermicides and products to control other invertebrates

Products used for the control of molluscs, worms and invertebrates not covered by other product-types, by means other than repulsion or attraction.

Product-type 17:   Piscicides

Products used for the control of fish, by means other than repulsion or attraction.

Product-type 18:   Insecticides, acaricides and products to control other arthropods

Products used for the control of arthropods (e.g. insects, arachnids and crustaceans), by means other than repulsion or attraction.

Product-type 19:   Repellents and attractants

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.

Product-type 20:   Control of other vertebrates

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.

MAIN GROUP 4:   Other biocidal products

Product-type 21:   Antifouling products

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.

Product-type 22:   Embalming and taxidermist fluids

Products used for the disinfection and preservation of human or animal corpses, or parts thereof.

ANNEX VI

COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS

CONTENTS	CONTENTS
	Terms and definitions
	Introduction
	Assessment
—	General principles
—	Effects on human and animal health
—	Effects on the environment
—	Effects on target organisms
—	Efficacy
—	Summary
	Conclusions
—	General principles
—	Effects on human and animal health
—	Effects on the environment
—	Effects on target organisms
—	Efficacy
—	Summary
	Overall integration of conclusions

TERMS AND DEFINITIONS

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 ([^E0061]), 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’.

Technical definitions

(a) Hazard identification

The identification of the adverse effects which a biocidal product has an inherent capacity to cause.

(b) Dose (concentration) — response (effect) assessment