INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS
1. This Annex sets out the information requirements that shall be included in the dossier for the biocidal product accompanying an application for the approval of an active substance in accordance with point (b) of Article 6(1) and the dossier accompanying an application for the authorisation of a biocidal product in accordance with point (a) of Article 20(1).
2. The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS). The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all biocidal products.
With regard to the ADS, the data elements to be provided for a specific biocidal product shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the product, existing data, information which is part of the CDS and the types of products and the exposure patterns related to these uses.
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex III table. The general considerations regarding adaptation of information requirements as set out in Annex IV to this Regulation shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates.
For some of the information requirements set out in this Annex, it may be possible to satisfy these requirements based on available information of the properties of the active substance(s) contained in the product and the properties of non-active substance(s) included in the product. For non-active substances, applicants shall use the information provided to them in the context of Title IV of Regulation (EC) No 1907/2006, where relevant, and the information made available by the Agency in accordance with point (e) of Article 77(2) of that Regulation. However, the information may be not sufficient or adequate to determine whether a non-active substance contained in a biocidal product has hazardous properties and the evaluating body may conclude that further data are required.
The relevant calculation methods used for the classification of mixtures as laid down in Regulation (EC) No 1272/2008 shall, where appropriate, be applied in the hazard assessment of the biocidal product. Such calculation methods shall not be used if, in relation to a particular hazard, synergistic and antagonistic effects between the different substances contained in the product are considered likely.
Detailed technical guidance regarding the application of this Annex and the preparation of the dossier is available on the website of the Agency.
The applicant 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, (42) 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 | ►M12 Column 3 Specific rules for adaptation from column 1 ◄ |
1. APPLICANT | ||
1.1. Name and address, etc. | ||
1.2. Contact person | ||
1.3. Manufacturer and formulator of the biocidal product and the active substance(s) (names, addresses, including location of plant(s)) | ||
2. IDENTITY OF THE BIOCIDAL PRODUCT | ||
2.1. Trade name or proposed trade name | ||
2.2. 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 | ||
▼M2 | ||
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 | ||
▼B | ||
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) | ||
▼M12 | ||
6.6. The proposed claims for the product and, where claims are made, for treated articles regarding the biocidal properties conferred to the article | ||
▼B | ||
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 | ||
▼M12 | ||
6.8.2. Observations on undesirable or unintended side-effects on non-target organisms or on objects and material to be protected | ||
▼B | ||
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 | ||
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 | ►M12 Column 3 Specific rules for adaptation from column 1 ◄ |
1. APPLICANT | ||
1.1. Name and address | ||
1.2. Contact person | ||
1.3. Manufacturer and formulator of the biocidal product and the micro-organism(s) (names, addresses, including location of plant(s)) | ||
2. IDENTITY OF THE BIOCIDAL PRODUCTS | ||
2.1. Trade name or proposed trade name | ||
2.2. Manufacturer’s development code and number of the biocidal product, if appropriate | ||
▼M12 | ||
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 | ||
▼B | ||
2.4. Formulation type and nature of the biocidal product | ||
▼M2 | ||
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 | ||
▼B | ||
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 | ||
▼M12 ————— | ||
▼M12 | ||
3.6.8. Spraying patterns – aerosols | ||
3.6.9. Other technical characteristics | ||
▼B | ||
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 | ||
▼M12 | ||
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 | ||
▼B | ||
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 | |