Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

Core data set and additional data set for chemical products U.K.

Information required to support the authorisation of a biocidal product is listed in the table below.

For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply.

a Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties.
Column 1Information required:	Column 2All data is CDS unless indicated as ADS	Column 3Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates
1. APPLICANT
1.1. Name and address, etc.
1.2. Contact person
1.3. Manufacturer and formulator of the biocidal product and the active substance(s) (names, addresses, including location of plant(s))
2. IDENTITY OF THE BIOCIDAL PRODUCT
2.1. Trade name or proposed trade name
2.2. Manufacturer’s development code and number of the product, if appropriate
2.3. Complete quantitative (g/kg, g/l or % w/w (v/v)) composition of the biocidal product, i.e. declaration of all active substances and non-active substances (substance or mixture according to Article 3 of Regulation (EC) No 1907/2006), which are intentionally added to the biocidal product (formulation) as well as detailed quantitative and qualitative information on the composition of the active substance(s) contained in the biocidal product. For non-active substances, a safety data sheet in compliance with Article 31 of Regulation (EC) No 1907/2006 has to be provided. In addition, all relevant information on individual ingredients, their function and, in the case of a reaction mixture, the final composition of the biocidal product shall be given
2.4. Formulation type and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder, solution
[F1 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
3.1. Appearance (at 20 °C and 101,3 kPa)
3.1.1. Physical state (at 20 °C and 101,3 kPa)
3.1.2. Colour (at 20 °C and 101,3 kPa)
3.1.3. Odour (at 20 °C and 101,3 kPa)
3.2. Acidity/alkalinity The test is applicable when the pH of the biocidal product or its dispersion in water (1 %) is outside the pH range 4-10
3.3. Relative density (liquids) and bulk, tap density (solids)
3.4. Storage stability, stability and shelf-life
3.4.1. Storage stability tests
3.4.1.1. Accelerated storage test
3.4.1.2. Long term storage test at ambient temperature
3.4.1.3. Low temperature stability test (liquids)
3.4.2. Effects on content of the active substance and technical characteristics of the biocidal product
3.4.2.1. Light
3.4.2.2. Temperature and humidity
3.4.2.3. Reactivity towards container material
3.5. Technical characteristics of the biocidal product
3.5.1. Wettability
3.5.2. Suspensibility, spontaneity and dispersion stability
3.5.3. Wet sieve analysis and dry sieve test
3.5.4. Emulsifiability, re-emulsifiability and emulsion stability
3.5.5. Disintegration time
3.5.6. Particle size distribution, content of dust/fines, attrition, friability
3.5.7. Persistent foaming
3.5.8. Flowability/Pourability/Dustability
3.5.9. Burning rate — smoke generators
3.5.10. Burning completeness — smoke generators
3.5.11. Composition of smoke — smoke generators
3.5.12. Spraying pattern — aerosols
3.5.13. Other technical characteristics
3.6. Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised
3.6.1. Physical compatibility
3.6.2. Chemical compatibility
3.7. Degree of dissolution and dilution stability
3.8. Surface tension
3.9. Viscosity
4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS
4.1. Explosives
4.2. Flammable gases
4.3. Flammable aerosols
4.4. Oxidising gases
4.5. Gases under pressure
4.6. Flammable liquids
4.7. Flammable solids
4.8. Self-reactive substances and mixtures
4.9. Pyrophoric liquids
4.10. Pyrophoric solids
4.11. Self-heating substances and mixtures
4.12. Substances and mixtures which in contact with water emit flammable gases
4.13. Oxidising liquids
4.14. Oxidising solids
4.15. Organic peroxides
4.16. Corrosive to metals
4.17. Additional physical indications of hazard
4.17.1. Auto-ignition temperatures of products (liquids and gases)
4.17.2. Relative self-ignition temperature for solids
4.17.3. Dust explosion hazard
5. METHODS OF DETECTION AND IDENTIFICATION
5.1. Analytical method including validation parameters for determining the concentration of the active substance(s), residues, relevant impurities and substances of concern in the biocidal product
5.2. In so far as not covered by Annex II 5.2 and 5.3, analytical methods for monitoring purposes including recovery rates and the limits of determination of relevant components of the biocidal product and/or residues thereof, where relevant in or on the following:	ADS
5.2.1. Soil	ADS
5.2.2. Air	ADS
5.2.3. Water (including drinking water) and sediment	ADS
5.2.4. Animal and human body fluids and tissues	ADS
5.3. Analytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance nor the material treated with it come into contact with food- producing animals, food of plant and animal origin or feeding stuffs)	ADS
6. EFFECTIVENESS AGAINST TARGET ORGANISMS
6.1. Function, e.g. fungicide, rodenticide, insecticide, bactericide Mode of control e.g. attracting, killing, inhibiting
6.2. Representative organism(s) to be controlled and products, organisms or objects to be protected
6.3. Effects on representative target organisms
6.4. Likely concentration at which the active substance will be used
6.5. Mode of action (including time delay)
6.6. The proposed label claims for the product and, where label claims are made, for treated articles
6.7. Efficacy data to support these claims, including any available standard protocols, laboratory tests or field trials used including performance standards where appropriate and relevant
6.8. Any known limitations on efficacy
6.8.1. Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies
6.8.2. Observations on undesirable or unintended side effects e.g. on beneficial and other non-target organisms
6.9. Summary and evaluation
7. INTENDED USES AND EXPOSURE
7.1. Field(s) of use envisaged for biocidal products and, where appropriate, treated articles
7.2. 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 of this endpoint shall be carried out according to the sequential testing strategy for dermal irritation and corrosion set out in the Appendix to Test Guideline B.4. Acute Toxicity-Dermal Irritation/Corrosion (Annex B.4. to Regulation (EC) No 440/2008)		Testing on the product/mixture does not need to be conducted if: there are valid data available on each of the components in the mixture sufficient to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected
8.2. Eye irritationa The assessment of this endpoint shall be carried out according to the sequential testing strategy for eye irritation and corrosion as set down in the Appendix to Test Guideline B.5.Acute Toxicity: Eye Irritation/Corrosion (Annex B.5. to Regulation (EC) No 440/2008)		Testing on the product/mixture does not need to be conducted if: there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/ECand Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected
8.3. Skin sensitisation The assessment of this endpoint shall comprise the following consecutive steps: 1. an assessment of the available human, animal and alternative data 2. in vivo testing The Murine Local Lymph Node Assay (LLNA) including, where appropriate, the reduced variant of the assay, is the first-choice method for in vivo testing. If another skin sensitisation test is used justification shall be provided		Testing on the product/mixture does not need to be conducted if: there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected the available information indicates that the product should be classified for skin sensitisation or corrosivity; or the substance is a strong acid (pH < 2,0) or base (pH > 11,5)
8.4. Respiratory sensitisation	ADS	Testing on the product/mixture does not need to be conducted if: there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected
8.5. Acute toxicity Classification using the tiered approach to classification of mixtures for acute toxicity in Regulation (EC) No 1272/2008 is the default approach		Testing on the product/mixture does not need to be conducted if: there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected
8.5.1. 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: non-active substance(s) (i.e. substance(s) of concern), or a mixture that a substance(s) of concern is a component of If insufficient data are available for a non-active substance(s) and cannot be inferred through read-across or other accepted non-testing approaches, targeted test(s) described in Annex II shall be carried out for the substance(s) of concern or a mixture that a substance(s) of concern is a component of		Testing on the product/mixture does not need to be conducted if: there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP)
8.8. Food and feedingstuffs studies	ADS
8.8.1. If residues of the biocidal product remain in or on feedingstuffs for a significant period of time, then feeding and metabolism studies in livestock shall be required to permit evaluation of residues in food of animal origin	ADS
8.9. Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the biocidal product	ADS
8.10. Other test(s) related to the exposure to humans Suitable test(s) and a reasoned case will be required for the biocidal product In addition, for certain biocides which are applied directly or around livestock (including horses) residue studies might be needed	ADS
9. ECOTOXICOLOGICAL STUDIES
9.1. Information relating to the ecotoxicity of the biocidal product which is sufficient to enable a decision to be made concerning the classification of the product is required Where there are valid data available on each of the components in the mixture and synergistic effects between any of the components are not expected, classification of the mixture can be made according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP) Where valid data on the components are not available or where synergistic effects may be expected then testing of components and/or the biocidal product itself may be necessary
9.2. Further Ecotoxicological studies Further studies chosen from among the endpoints referred to in Section 9 of Annex II for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product
9.3. Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk	ADS	Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment
9.4. If the biocidal product is in the form of bait or granules the following studies may be required:
9.4.1. Supervised trials to assess risks to non-target organisms under field conditions
9.4.2. Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought to be at risk
9.5. Secondary ecological effect e.g. when a large proportion of a specific habitat type is treated	ADS
10. ENVIRONMENTAL FATE AND BEHAVIOUR
The test requirements below are applicable only to the relevant components of the biocidal product
10.1. Foreseeable routes of entry into the environment on the basis of the use envisaged
10.2. Further studies on fate and behaviour in the environment Further studies chosen from among the endpoints referred to in Section 10 of Annex II for relevant components of the biocidal product or the biocidal product itself may be required. For products that are used outside, with direct emission to soil, water or surfaces, the components in the product may influence the fate and behaviour (and ecotoxicity) of the active substance. Data are required unless it is scientifically justified that the fate of the components in the product is covered by the data provided for the active substance and other identified substances of concern	ADS
10.3. Leaching behaviour	ADS
10.4. Testing for distribution and dissipation in the following:	ADS
10.4.1. Soil	ADS
10.4.2. Water and sediment	ADS
10.4.3. Air	ADS
10.5. If the biocidal product is to be sprayed near to surface waters then an overspray study may be required to assess risks to aquatic organisms or plants under field conditions	ADS
10.6. If the biocidal product is to be sprayed outside or if potential for large scale formation of dust is given then data on overspray behaviour may be required to assess risks to bees and non-target arthropods under field conditions	ADS
11. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT
11.1. Recommended methods and precautions concerning handling, use, storage, disposal, transport or fire
11.2. Identity of relevant combustion products in cases of fire
11.3. Specific treatment in case of an accident, e.g. first-aid measures, antidotes, medical treatment if available; emergency measures to protect the environment
11.4. Possibility of destruction or decontamination following release in or on the following:
11.4.1. Air
11.4.2. Water, including drinking water
11.4.3. Soil
11.5. Procedures for waste management of the biocidal product and its packaging for industrial use, use by trained professionals, professional users and non-professional users (e.g. possibility of reuse or recycling, neutralisation, conditions for controlled discharge, and incineration)
11.6. Procedures for cleaning application equipment where relevant
11.7. Specify any repellents or poison control measures included in the product that are present to prevent action against non-target organisms
12. CLASSIFICATION, LABELLING, AND PACKAGING
As established in point (b) of Article 20(1), proposals including justification for the hazard and precautionary statements in accordance with the provisions set in Directive 1999/45/EC and Regulation (EC) No 1272/2008 must be submitted. Example labels, instructions for use and safety data sheets shall be provided
12.1. Hazard classification
12.2. Hazard pictogram
12.3. Signal word
12.4. Hazard statements
12.5. Precautionary statements including prevention, response, storage and disposal
12.6. Proposals for safety-data sheets should be provided, where appropriate
12.7. Packaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included
13. EVALUATION AND SUMMARY The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed

Textual Amendments

F1 Inserted by Commission Delegated Regulation (EU) No 837/2013 of 25 June 2013 amending Annex III to Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the information requirements for authorisation of biocidal products (Text with EEA relevance).