Commission Directive 2006/50/EC (repealed)Dangos y teitl llawn

“ANNEX IVA

DATA SET FOR ACTIVE SUBSTANCES MICRO-ORGANISMS INCLUDING VIRUSES AND FUNGI

1. For the purposes of this Annex, the term micro-organisms shall be understood as including also viruses and fungi. Dossiers on active micro-organisms shall address at least all the points listed under “Dossier requirements” below. For all micro-organisms subject to an application for inclusion into Annex I or IA, all available relevant knowledge and information in literature must be provided. The information related to the identification and characterisation of a micro-organism including mode of action is particularly important and must be entered in sections I to IV and provides the basis for an assessment of potential impacts on human health and of environmental effects.

2. Where information is not necessary owing to the nature of the micro-organism Article 8(5) shall apply.

3. A dossier within the meaning of Article 11(1) shall be prepared on strain level of the micro-organism unless information is submitted that shows that the species is known to be sufficiently homogeneous regarding all characteristics, or the applicant provides other arguments in accordance with Article 8(5).

4. Where the micro-organism has been genetically modified within the meaning of Article 2(2) of Directive 2001/18/EC, a copy of the evaluation of the data concerning the assessment of the risks to the environment as established in Article 4(2) of that Directive, shall also be submitted.

5. If the biocidal product action is known to be partly or entirely due to the effect of a toxin/metabolite, or if significant residues of toxins/metabolites are to be expected not related to the effect of the active micro-organism, a dossier for the toxin/metabolite shall be submitted in accordance with the requirements of Annexes IIA and, where specified, the relevant parts of Annex IIIA.

Dossier requirements

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

1.1. Applicant

1.2. Manufacturer

1.3. Name and species description, strain characterisation

1.3.1. Common name of the micro-organism (including alternative and superseded names)

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

1.3.3. Collection and culture reference number where the culture is deposited

1.3.4. Methods, procedures and criteria used to establish the presence and identity of the micro-organism (e.g. morphology, biochemistry, serology, etc.)

1.4. Specification of the material used for manufacturing of formulated products

1.4.1. Content of the micro-organism

1.4.2. Identity and content of impurities, additives, contaminating micro-organisms

1.4.3. Analytical profile of batches

II. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM

2.1. History of the micro-organism and its uses. Natural occurrence and geographical distribution

2.1.1. Historical background

2.1.2. Origin and natural occurrence

2.2. Information on target organism(s)

2.2.1. Description of the target organism(s)

2.2.2. Mode of action

2.3. Host specificity range and effects on species other than the target organism

2.4. Development stages/life cycle of the micro-organism

2.5. Infectiveness, dispersal and colonisation ability

2.6. Relationships to known plant or animal or human pathogens

2.7. Genetic stability and factors affecting it

2.8. Information on the production of metabolites (especially toxins)

2.9. Antibiotics and other anti-microbial agents

2.10. Robustness to environmental factors

2.11. Effects on materials, substances and products

III. FURTHER INFORMATION ON THE MICRO-ORGANISM

3.1. Function

3.2. Field of use envisaged

3.3. Product type(s) and category of users for which the micro-organism should be listed in Annex I, IA or IB

3.4. Method of production and quality control

3.5. Information on the occurrence or possible occurrence of the development of resistance of the target organism(s)

3.6. Methods to prevent loss of virulence of seed stock of the micro-organism

3.7. Recommended methods and precautions concerning handling, storage, transport or fire

3.8. Procedures for destruction or decontamination

3.9. Measures in case of an accident

3.10. Procedures for waste management

3.11. Monitoring plan to be used for the active micro-organism including handling, storage, transport and use

IV. ANALYTICAL METHODS

4.1. Methods for the analysis of the micro-organism as manufactured

4.2. Methods to determine and quantify residues (viable or non-viable)

V. EFFECTS ON HUMAN HEALTH

TIER I

5.1. Basic information

5.1.1. Medical data

5.1.2. Medical surveillance on manufacturing plant personnel

5.1.3. Sensitisation/allergenicity observations

5.1.4. Direct observation, e.g. clinical cases

5.2. Basic studies

5.2.1. Sensitisation

5.2.2. Acute toxicity, pathogenicity, and infectiveness

5.2.2.1. Acute oral toxicity, pathogenicity and infectiveness

5.2.2.2. Acute inhalation toxicity, pathogenicity and infectiveness

5.2.2.3. Intraperitoneal/subcutaneous single dose

5.2.3. In vitro genotoxicity testing

5.2.4. Cell culture study

5.2.5. Information on short-term toxicity and pathogenicity

5.2.5.1. Health effects after repeated inhalatory exposure

5.2.6. Proposed treatment: first aid measures, medical treatment

5.2.7. Any pathogenicity and infectiveness to humans and other mammals under conditions of immunosuppression

END OF TIER I

TIER II

5.3. Specific toxicity, pathogenicity and infectiveness studies

5.4. Genotoxicity — In vivo studies in somatic cells

5.5. Genotoxicity — In vivo studies in germ cells

END OF TIER II

5.6. Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation

VI. RESIDUES IN OR ON TREATED MATERIALS, FOOD AND FEED

6.1. Persistence and likelihood of multiplication in or on treated materials, feedingstuffs or foodstuffs

6.2. Further information required

6.2.1. Non-viable residues

6.2.2. Viable residues

6.3. Summary and evaluation of residues in or on treated materials, food and feed

VII. FATE AND BEHAVIOUR IN THE ENVIRONMENT

7.1. Persistence and multiplication

7.1.1. Soil

7.1.2. Water

7.1.3. Air

7.2. Mobility

7.3. Summary and evaluation of fate and behaviour in the environment

VIII. EFFECTS ON NON-TARGET ORGANISMS

8.1. Effects on birds

8.2. Effects on aquatic organisms

8.2.1. Effects on fish

8.2.2. Effects on freshwater invertebrates

8.2.3. Effects on algae growth

8.2.4. Effects on plants other than algae

8.3. Effects on bees

8.4. Effects on arthropods other than bees

8.5. Effects on earthworms

8.6. Effects on soil micro-organisms

8.7. Further studies

8.7.1. Terrestrial plants

8.7.2. Mammals

8.7.3. Other relevant species and processes

8.8. Summary and evaluation of effects on non-target organisms

IX. CLASSIFICATION AND LABELLING

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

(1)

OJ L 262, 17.10.2000, p. 21.