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 Column 3 Specific 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 (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 Common name of the micro-organism (including alternative and superseded names) 2.2.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 2.4. Methods, procedures and criteria used to establish the presence and identity of the micro-organism 2.5. Specification of the technical grade active ingredient 2.6. Method of production and quality control 2.7. Content of the micro-organism 2.8. Identity and content of impurities, additives, contaminating micro-organisms 2.9. Analytical profile of batches 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 3.5. Information on the production of metabolites (especially toxins) 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 4.1. Analytical methods for the analysis of the micro-organism as manufactured 4.2. Methods used for monitoring purposes to determine and quantify residues (viable or non-viable) 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 8.7. Further studies ADS 8.7.1. Terrestrial plants ADS 8.7.2. Mammals ADS 8.7.3. Other relevant species and processes ADS 8.8. Summary and evaluation of effects on non-target organisms 9. ENVIRONMENTAL FATE AND BEHAVIOUR 9.1. Persistence and multiplication 9.1.1. Soil 9.1.2. Water 9.1.3. Air 9.1.4. Mobility 9.1.5. Summary and evaluation of fate and behaviour in the environment 10. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT 10.1. Recommended methods and precautions concerning handling, storage, transport or fire 10.2. Emergency measures in case of an accident 10.3. Procedures for destruction or decontamination 10.4. Procedures for waste management 10.5. Monitoring plan to be used for the active micro-organism including handling, storage, transport and use 11. CLASSIFICATION, LABELLING AND PACKAGING OF THE MICRO-ORGANISM 11.1. Relevant risk group specified in Article 2 of Directive 2000/54/EC 12. 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

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.