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Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (repealed)
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- Directives originating from the EU
- 1998 No. 8
- ANNEX IVA
- Dossier requirements
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[F1Dossier requirements U.K.
SECTIONS:
I.
Identity of the micro-organism
II.
Biological properties of the micro-organism
III.
Further information on the micro-organism
IV.
Analytical methods
V.
Effects on human health
VI.
Residues in or on treated materials, food and feed
VII.
Fate and behaviour in the environment
VIII.
Effects on non-target organisms
IX.
Classification and labelling
X.
Summary and evaluation of sections I to IX including conclusions of the risk assessment and recommendations
The following data will be required to support submissions on the above points.
I. IDENTITY OF THE MICRO-ORGANISM U.K.
1.1. Applicant U.K.
1.2. Manufacturer U.K.
1.3. Name and species description, strain characterisation U.K.
1.3.1. Common name of the micro-organism (including alternative and superseded names) U.K.
1.3.2. Taxonomic name and strain indicating whether it is a stock variant, a mutant strain or a genetically modified organism (GMO); for viruses, taxonomic designation of the agent, serotype, strain or mutant U.K.
1.3.3. Collection and culture reference number where the culture is deposited U.K.
1.3.4. Methods, procedures and criteria used to establish the presence and identity of the micro-organism (e.g. morphology, biochemistry, serology, etc.) U.K.
1.4. Specification of the material used for manufacturing of formulated products U.K.
1.4.1. Content of the micro-organism U.K.
1.4.2. Identity and content of impurities, additives, contaminating micro-organisms U.K.
1.4.3. Analytical profile of batches U.K.
II. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM U.K.
2.1. History of the micro-organism and its uses. Natural occurrence and geographical distribution U.K.
2.1.1. Historical background U.K.
2.1.2. Origin and natural occurrence U.K.
2.2. Information on target organism(s) U.K.
2.2.1. Description of the target organism(s) U.K.
2.2.2. Mode of action U.K.
2.3. Host specificity range and effects on species other than the target organism U.K.
2.4. Development stages/life cycle of the micro-organism U.K.
2.5. Infectiveness, dispersal and colonisation ability U.K.
2.6. Relationships to known plant or animal or human pathogens U.K.
2.7. Genetic stability and factors affecting it U.K.
2.8. Information on the production of metabolites (especially toxins) U.K.
2.9. Antibiotics and other anti-microbial agents U.K.
2.10. Robustness to environmental factors U.K.
2.11. Effects on materials, substances and products U.K.
III. FURTHER INFORMATION ON THE MICRO-ORGANISM U.K.
3.1. Function U.K.
3.2. Field of use envisaged U.K.
3.3. Product type(s) and category of users for which the micro-organism should be listed in Annex I, IA or IB U.K.
3.4. Method of production and quality control U.K.
3.5. Information on the occurrence or possible occurrence of the development of resistance of the target organism(s) U.K.
3.6. Methods to prevent loss of virulence of seed stock of the micro-organism U.K.
3.7. Recommended methods and precautions concerning handling, storage, transport or fire U.K.
3.8. Procedures for destruction or decontamination U.K.
3.9. Measures in case of an accident U.K.
3.10. Procedures for waste management U.K.
3.11. Monitoring plan to be used for the active micro-organism including handling, storage, transport and use U.K.
IV. ANALYTICAL METHODS U.K.
4.1. Methods for the analysis of the micro-organism as manufactured U.K.
4.2. Methods to determine and quantify residues (viable or non-viable) U.K.
V. EFFECTS ON HUMAN HEALTH U.K.
TIER I U.K.
5.1. Basic information U.K.
5.1.1. Medical data U.K.
5.1.2. Medical surveillance on manufacturing plant personnel U.K.
5.1.3. Sensitisation/allergenicity observations U.K.
5.1.4. Direct observation, e.g. clinical cases U.K.
5.2. Basic studies U.K.
5.2.1. Sensitisation U.K.
5.2.2. Acute toxicity, pathogenicity, and infectiveness U.K.
5.2.2.1. Acute oral toxicity, pathogenicity and infectiveness U.K.
5.2.2.2. Acute inhalation toxicity, pathogenicity and infectiveness U.K.
5.2.2.3. Intraperitoneal/subcutaneous single dose U.K.
5.2.3. In vitro genotoxicity testing U.K.
5.2.4. Cell culture study U.K.
5.2.5. Information on short-term toxicity and pathogenicity U.K.
5.2.5.1. Health effects after repeated inhalatory exposure U.K.
5.2.6. Proposed treatment: first aid measures, medical treatment U.K.
5.2.7. Any pathogenicity and infectiveness to humans and other mammals under conditions of immunosuppression U.K.
END OF TIER I U.K.
TIER II U.K.
5.3. Specific toxicity, pathogenicity and infectiveness studies U.K.
5.4. Genotoxicity — In vivo studies in somatic cells U.K.
5.5. Genotoxicity — In vivo studies in germ cells U.K.
END OF TIER II U.K.
5.6. Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation U.K.
VI. RESIDUES IN OR ON TREATED MATERIALS, FOOD AND FEED U.K.
6.1. Persistence and likelihood of multiplication in or on treated materials, feedingstuffs or foodstuffs U.K.
6.2. Further information required U.K.
6.2.1. Non-viable residues U.K.
6.2.2. Viable residues U.K.
6.3. Summary and evaluation of residues in or on treated materials, food and feed U.K.
VII. FATE AND BEHAVIOUR IN THE ENVIRONMENT U.K.
7.1. Persistence and multiplication U.K.
7.1.1. Soil U.K.
7.1.2. Water U.K.
7.1.3. Air U.K.
7.2. Mobility U.K.
7.3. Summary and evaluation of fate and behaviour in the environment U.K.
VIII. EFFECTS ON NON-TARGET ORGANISMS U.K.
8.1. Effects on birds U.K.
8.2. Effects on aquatic organisms U.K.
8.2.1. Effects on fish U.K.
8.2.2. Effects on freshwater invertebrates U.K.
8.2.3. Effects on algae growth U.K.
8.2.4. Effects on plants other than algae U.K.
8.3. Effects on bees U.K.
8.4. Effects on arthropods other than bees U.K.
8.5. Effects on earthworms U.K.
8.6. Effects on soil micro-organisms U.K.
8.7. Further studies U.K.
8.7.1. Terrestrial plants U.K.
8.7.2. Mammals U.K.
8.7.3. Other relevant species and processes U.K.
8.8. Summary and evaluation of effects on non-target organisms U.K.
IX. CLASSIFICATION AND LABELLING U.K.
The dossier shall be accompanied by a reasoned proposals for allocating an active substance which is a micro-organism to one of the risk groups specified in Article 2 of Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (1) together with indications on the need for products to carry the biohazard sign specified in Annex II to that Directive.
X. SUMMARY AND EVALUATION OF SECTIONS I TO IX INCLUDING CONCLUSIONS OF THE RISK ASSESSMENT AND RECOMMENDATIONS] U.K.
Textual Amendments
(1)
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