INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES
1. This Annex sets out the information requirements for the preparation of the dossier referred to in point (a) of Article 6(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 active substances. However, in some cases the physical or chemical properties of the substance may mean that it is impossible or unnecessary to provide specific data elements belonging to the CDS.
With regard to the ADS, the data elements to be provided for a specific active substance 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 substance, existing data, information which is part of the CDS and the types of products in which the active substance will be used 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 II table. The general considerations regarding adaptation of information requirements as set out in Annex IV shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the Annex II table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates. The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria referred to in Article 4(1) are met.
The applicant should consult the detailed technical guidance regarding the application of this Annex and the preparation of the dossier referred to in point (a) of Article 6(1), which 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), 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 it is necessary to carry out the evaluation as indicated in Article 8(2).
3. A detailed and full description of the studies conducted or referred to 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. Evidence should also be provided to demonstrate that the active substance upon which the tests have been carried out is the same as the substance for which the application has been submitted.
4. The formats made available by the Agency must be used for submission of the dossiers. In addition, IUCLID must 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 website of the Agency.
5. Tests submitted for the purpose of the approval of an active substance shall be conducted in accordance with the methods described in Commission Regulation (EC) No 440/2008 (39), 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, 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 of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes (40) and in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances (41) 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 description (specification) of the active substance used and its impurities must be provided. Testing should be performed with the active substance as manufactured or, in the case of some of the physical and chemical properties (see indications given in column I of the table), with a purified form of the active substance.
8. Where test data exist that have been generated before 1 September 2013 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 concerned, on a case-by-case basis, taking into account, among other factors, the need to minimise testing on vertebrates.
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 SUBSTANCES
Core data set and additional data set for active substances
Information required to support the approval of an active substance is listed in the table below.
Conditions for not requiring a specific test that are set out in the appropriate test methods in the Regulation (EC) No 440/2008 and are not repeated in column 3, 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. Active substance manufacturer (name, address and location of manufacturing plant(s)) | ||
▼M12 | ||
2. IDENTITY OF THE ACTIVE SUBSTANCE (AND ITS PRECURSOR(S) IF THE ACTIVE SUBSTANCE IS GENERATED IN SITU) | ||
For the active substance and, if applicable, its precursors, the information given in this Section shall be sufficient to enable the active substance to be identified. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items listed in this Section, the reasons shall be clearly stated | ||
▼B | ||
2.1. Common name proposed or accepted by ISO and synonyms (usual name, trade name, abbreviation) | ||
2.2. Chemical name (IUPAC and CA nomenclature or other international chemical name(s)) | ||
2.3. Manufacturer’s development code number(s) | ||
2.4. CAS number plus EC, INDEX and CIPAC numbers | ||
▼M12 | ||
2.5. Molecular and structural formula (including SMILES notation, if available and appropriate). For precursor(s) and for active substances generated in situ, information about all generated chemical substances (intended and unintended) | In case it is not possible to exactly define the molecular structure of the precursor(s) and/or active substance, the molecular and structural formulas do not need to be provided | |
▼B | ||
2.6. Information on optical activity and full details of any isomeric composition (if applicable and appropriate) | ||
2.7. Molar mass | ||
▼M12 | ||
2.8. Method of manufacture (syntheses pathways) of active substance including information on starting materials and solvents including suppliers, specifications and commercial availability. For active substances generated in situ, a description of the reaction schemes including all intermediate reactions and their associated chemical substances (intended and unintended) shall be provided | ||
▼B | ||
2.9. Specification of purity of the active substance as manufactured in g/kg, g/l or %w/w (v/v) as appropriate, providing inclusively the upper and lower limit | ||
2.10. The identity of any impurities and additives including by-products of synthesis, optical isomers, degradation products (if the substance is unstable) un-reacted and end-groups etc. of polymers and un-reacted starting materials of UVC-substances | ||
2.11. Analytical profile of at least five representative batches (g/kg active substance) including information on content of the impurities referred to in 2.10. | ||
▼M12 | ||
2.11.1. Analytical profile of at least five representative samples taken from the in situ generated substance(s), providing information on the content of the active substance(s) and any other constituent above 0,1 % w/w, including residues of precursor(s) | ||
▼B | ||
2.12. The origin of the natural active substance or the precursor(s) of the active substance, e.g. an extract of a flower | ||
3. PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE | ||
3.1. Appearance (1) | ||
3.1.1. Aggregate state (at 20 °C and 101,3 kPa) | ||
3.1.2. Physical state (i.e. viscous, crystalline, powder) (at 20 °C and 101,3 kPa) | ||
3.1.3. Colour (at 20 °C and 101,3 kPa) | ||
3.1.4. Odour (at 20 °C and 101,3 kPa) | ||
3.2. Melting/freezing point (2) | ||
3.3. Acidity, alkalinity | ||
3.4. Boiling point (2) | ||
3.5. Relative Density (2) | ||
3.6. Absorption spectra data (UV/VIS, IR, NMR) and a mass spectrum, molar extinction coefficient at relevant wavelengths, where relevant (2) | ||
3.7. Vapour pressure (2) | ||
3.7.1. Henry’s law constant must always be stated for solids and liquids if it can be calculated | ||
3.8. Surface tension (2) | ||
3.9. Water solubility (2) | ||
3.10. Partition coefficient (n-octanol/water) and its pH dependency (2) | ||
3.11. Thermal stability, identity of breakdown products (2) | ||
3.12. Reactivity towards container material | ||
3.13. Dissociation constant | ADS | |
3.14. Granulometry | ||
3.15. Viscosity | ADS | |
3.16. Solubility in organic solvents, including effect of temperature on solubility (2) | ADS | |
3.17. Stability in organic solvents used in biocidal products and identity of relevant breakdown products (1) | ADS | |
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 indicators for hazards | ||
4.17.1. Auto-ignition temperature (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 methods including validation parameters for the determination of active substance as manufactured and where appropriate, for relevant residues, isomers and impurities of the active substance and additives (e.g. stabilisers) For impurities other than relevant impurities this only applies if they are present at ≥ 1 g/kg | ||
5.2. Analytical methods for monitoring purposes including recovery rates and the limits of quantification and detection for the active substance, and for residues thereof in/on the following where relevant | ||
5.2.1. Soil | ||
5.2.2. Air | ||
5.2.3. Water (surface, drinking etc.) and sediment | ||
5.2.4. Animal and human body fluids and tissues | ||
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 articles treated with it come into contact with food-producing animals, food of plant or animal origin or feeding stuffs) | ADS | |
6. EFFECTIVENESS AGAINST TARGET ORGANISMS | ||
6.1. Function, e.g. fungicide, rodenticide, insecticide, bactericide and 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 organism(s) | ||
6.4. Likely concentration at which the active substance will be used in products and, where appropriate, in treated articles | ||
6.5. Mode of action (including time delay) | ||
▼M12 | ||
6.6. Efficacy data to support: — the innate activity of the active substance for the intended use(s), and — any claims made on treated articles regarding the biocidal properties conferred to the article. Efficacy data shall include any available standard protocols, laboratory tests or field trials and performance standards where appropriate, or data similar to those available for suitable reference products | ||
▼B | ||
6.7. Any known limitations on efficacy | ||
6.7.1. Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies | ||
▼M12 | ||
6.7.2. Observations on undesirable or unintended side effects on non-target organisms or on objects and material to be protected | ||
▼B | ||
7. INTENDED USES AND EXPOSURE | ||
7.1. Field of use(s) envisaged for biocidal products and, where appropriate, treated articles | ||
7.2. Product-type(s) | ||
7.3. Detailed description of the intended use pattern(s) including in treated articles | ||
7.4. Users 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 the envisaged major use categories | ||
TITLE 2
MICRO-ORGANISMS
Core data set and additional data set for active substances
Information required to support the approval of an active substance is listed in the table below.
Conditions for not requiring a specific test that are set out in the appropriate test methods in Regulation (EC) No 440/2008 that are not repeated in column 3, 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 (name, address and location of manufacturing plant) | ||
2. IDENTITY OF THE MICRO-ORGANISM | ||
2.1. Common name of the micro-organism (including alternative and superseded names) | ||
2.2. Taxonomic name and strain | ||
2.3. Collection and culture reference number where the culture is deposited | ||
▼M12 | ||
2.4. Specification of the technical grade active ingredient | ||
▼M12 | ||
2.4.1. Content of the active micro-organism and identity and content of relevant metabolites or toxins | ||
2.4.2. Identity and content of impurities, additives, contaminating micro-organisms | ||
2.4.3. Analytical profile of batches | ||
▼M12 | ||
2.5. Method of production and quality control | ||
▼M12 ————— | ||
▼B | ||
3. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM | ||
3.1. General information on the micro-organism | ||
3.1.1. Historical background | ||
3.1.2. Historical uses | ||
3.1.3. Origin, natural occurrence and geographical distribution | ||
3.2. Development stages/life cycle of the micro-organism | ||
3.3. Relationships to known plant or animal or human pathogens | ||
3.4. Genetic stability and factors affecting it | ||
▼M12 | ||
3.5. Information on the production of relevant metabolites and toxins | ||
▼B | ||
3.6. Production and resistance to antibiotics and other anti-microbial agents | ||
3.7. Robustness to environmental factors | ||
3.8. Further information on the micro-organism | ||
4. METHODS OF DETECTION AND IDENTIFICATION | ||
▼M12 | ||
4.1. Methods, procedures and criteria used to establish the presence and identity of the micro-organism | ||
4.2. Analytical methods for the analysis of the micro-organism as manufactured | ||
▼M12 | ||
4.3. Methods used for monitoring purposes to determine and quantify residues (viable or non-viable) | ||
▼B | ||
5. EFFECTIVENESS AGAINST TARGET ORGANISM | ||
5.1. Function and mode of control e.g. attracting, killing, inhibiting | ||
5.2. Infectiveness, dispersal and colonisation ability | ||
5.3. Representative organism(s) controlled and products, organisms or objects to be protected | ||
5.4. Effects on representative target organism(s) Effects on materials, substances and products | ||
5.5. Likely concentration at which the micro-organism will be used | ||
5.6. Mode of action (including time delay) | ||
5.7. Efficacy data | ||
5.8. Any known limitations on efficacy | ||
5.8.1. Information on the occurrence or possible occurrence of the development of resistance of the target organism(s) and appropriate management strategies | ||
5.8.2. Observations on undesirable or unintended side effects | ||
5.8.3. Host specificity, range and effects on species other than the target organism | ||
5.9. Methods to prevent loss of virulence of seed stock of the micro-organism | ||
6. INTENDED USES AND EXPOSURE | ||
6.1. Field of use(s) envisaged | ||
6.2. Product-type(s) | ||
6.3. Detailed description of the use pattern(s) | ||
6.4. Category of users for which the micro-organism should be approved | ||
6.5. Exposure data applying, as appropriate, the methodologies described in Section 5 of Annex I to Regulation (EC) No 1907/2006 | ||
6.5.1. Information on human exposure associated with the intended uses and disposal of the active substance | ||
6.5.2. Information on environmental exposure associated with the intended uses and disposal of the active substance | ||
6.5.3. Information on exposure of food-producing animals and food and feeding stuffs associated with the intended uses of the active substance | ||
7. EFFECT ON HUMAN AND ANIMAL HEALTH | Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. | |
7.1. Basic information | ||
7.1.1. Medical data | ||
7.1.2. Medical surveillance on manufacturing plant personnel | ||
7.1.3. Sensitisation/allergenicity observations | ||
7.1.4. Direct observation, e.g. clinical cases Any pathogenicity and infectiveness to humans and other mammals under conditions of immunosuppression | ||
7.2. Basic studies | ||
7.2.1. Sensitisation | ||
7.2.2. Acute toxicity, pathogenicity, and infectiveness | ||
7.2.2.1. Acute oral toxicity, pathogenicity and infectiveness | ||
7.2.2.2. Acute inhalatory toxicity, pathogenicity and infectiveness | ADS | |
7.2.2.3. Intraperitoneal/subcutaneous single dose | ADS | |
7.2.3. In vitro genotoxicity testing | ||
7.2.4. Cell culture study | ||
7.2.5. Information on short-term toxicity and pathogenicity | ADS | |
7.2.5.1. Health effects after repeated inhalatory exposure | ADS | |
7.2.6. Proposed treatment: first aid measures, medical treatment | ||
7.3. Specific toxicity, pathogenicity and infectiveness studies | ADS | |
7.4. Genotoxicity — in vivo studies in somatic cells | ADS | |
7.5. Genotoxicity — in vivo studies in germ cells | ADS | |
7.6. Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation | ||
7.7. Residues in or on treated articles, food and feedingstuffs | ADS | |
7.7.1. Persistence and likelihood of multiplication in or on treated articles, feedingstuffs or foodstuffs | ADS | |
7.7.2. Further information required | ADS | |
7.7.2.1. Non-viable residues | ADS | |
7.7.2.2. Viable residues | ADS | |
7.8. Summary and evaluation of residues in or on treated articles, food and feedingstuffs | ADS | |
8. EFFECTS ON NON-TARGET ORGANISMS | Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. | |
8.1. Effects on aquatic organisms | ||
8.1.1. Effects on fish | ||
8.1.2. Effects on freshwater invertebrates | ||
8.1.3. Effects on algae growth | ||
8.1.4. Effects on plants other than algae | ADS | |
8.2. Effects on earthworms | ||
8.3. Effects on soil micro-organisms | ||
8.4. Effects on birds | ||
8.5. Effects on bees | ||
8.6. Effects on arthropods other than bees | ||