| 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 |
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| 1. APPLICANT |
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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 |
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2.1.Common name of the micro-organism (including alternative and superseded names) | | |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 |
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| 3.1. General information on the micro-organism |
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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 |
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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 |
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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
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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 |
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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 |
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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 |
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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 |
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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
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| 7.2. Basic studies |
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7.2.1.Sensitisation | | |
| 7.2.2. Acute toxicity, pathogenicity, and infectiveness |
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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 |
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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 |
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| 9.1. Persistence and multiplication |
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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 |
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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 |
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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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