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

TITLE 2 U.K. MICRO-ORGANISMS U.K.

Core data set and additional data set 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.

Column 1Information required:	Column 2All data is CDS unless indicated as ADS	Column 3Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates
1. APPLICANT
1.1. Name and address
1.2. Contact person
1.3. Manufacturer and formulator of the biocidal product and the micro-organism(s) (names, addresses, including location of plant(s))
2. IDENTITY OF THE BIOCIDAL PRODUCTS
2.1. Trade name or proposed trade name
2.2. Manufacturer’s development code and number of the biocidal product, if appropriate
2.3. Detailed quantitative (g/kg, g/l or % w/w (v/v)) and qualitative information on the constitution, composition and function of the biocidal product, e.g. micro-organism, active substance(s) and product non-active substances and any other relevant components. All relevant information on individual ingredients and the final composition of the biocidal product shall be given
2.4. Formulation type and nature of the biocidal product
[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. 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
3.7. 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
4.3. Flammable aerosols
4.4. Oxidising gases
4.5. Gases under pressure
4.6. Flammable liquids
4.7. Flammable solids
4.8. Oxidising liquids
4.9. Oxidising solids
4.10. Organic peroxides
4.11. Corrosive to metals
4.12. Other physical indications of hazard
4.12.1. Auto-ignition temperatures of products (liquids and gases)
4.12.2. Relative self-ignition temperature for solids
4.12.3. Dust explosion hazard
5. METHODS OF DETECTION AND IDENTIFICATION
5.1. Analytical method for determining the concentration of the micro-organism(s) and substances of concern in the biocidal product
5.2. Analytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance nor the article treated with it does not come into contact with food-producing animals, food of plant and animal origin or feeding stuffs)	ADS
6. EFFECTIVENESS AGAINST TARGET ORGANISM
6.1. Function and mode of control
6.2. Representative pest organism(s) to be controlled and products, organisms or objects to be protected
6.3. Effects on representative target organisms
6.4. Likely concentration at which micro-organism will be used
6.5. 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
6.8.1. Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies
6.8.2. Observations on undesirable or unintended side effects
7. INTENDED USES AND EXPOSURE
7.1. Field of use envisaged
7.2. 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
7.9.1. 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
9.1. Information relating to the ecotoxicity of the biocidal product which is sufficient to enable a decision to be made concerning the classification of the product is required Where there are valid data available on each of the components in the mixture and synergistic effects between any of the components are not expected, classification of the mixture can be made according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP) Where valid data on the components are not available or where synergistic effects may be expected then testing of components and/or the biocidal product itself may be necessary
9.2. Further ecotoxicological studies Further studies chosen from among the endpoints referred to in Section 8 of Annex II ‘Micro-organisms’ for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product
9.3. Effects on any other specific non-target organisms (flora and fauna) believed to be at risk	ADS	Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment
9.4. If the biocidal product is in the form of bait or granules	ADS
9.4.1. Supervised trials to assess risks to non-target organisms under field conditions
9.4.2. Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought to be at risk
9.5. Secondary ecological effect e.g. when a large proportion of a specific habitat type is treated	ADS
10. ENVIRONMENTAL FATE AND BEHAVIOUR
10.1. Foreseeable routes of entry into the environment on the basis of the use envisaged
10.2. Further studies on fate and behaviour in the environment Where relevant, all the information required in Section 9 of Annex II ‘Micro-organisms’ may be required for the product For products that are used outside, with direct emission to soil, water or surfaces, the components in the product may influence the fate and behaviour (and ecotoxicity) of the active substance. Data are required unless it is scientifically justified that the fate of the components in the product is covered by the data provided for the active substance and other identified substances of concern	ADS
10.3. Leaching behaviour	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

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).