Division Core data set and additional data set for active substances

Name and address

Contact person

Manufacturer (name, address and location of manufacturing plant)

Common name of the micro-organism (including alternative and superseded names)

Taxonomic name and strain

Collection and culture reference number where the culture is deposited

F5...

...

...

...

Historical background

Historical uses

Origin, natural occurrence and geographical distribution

Development stages/life cycle of the micro-organism

Relationships to known plant or animal or human pathogens

Genetic stability and factors affecting it

Production and resistance to antibiotics and other anti-microbial agents

Robustness to environmental factors

Further information on the micro-organism

Function and mode of control e.g. attracting, killing, inhibiting

Infectiveness, dispersal and colonisation ability

Representative organism(s) controlled and products, organisms or objects to be protected

Effects on materials, substances and products

Likely concentration at which the micro-organism will be used

Mode of action (including time delay)

Efficacy data

Information on the occurrence or possible occurrence of the development of resistance of the target organism(s) and appropriate management strategies

Observations on undesirable or unintended side effects

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

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

Field of use(s) envisaged

Product-type(s)

Detailed description of the use pattern(s)

Category of users for which the micro-organism should be approved

Information on human exposure associated with the intended uses and disposal of the active substance

Information on environmental exposure associated with the intended uses and disposal of the active substance

Information on exposure of food-producing animals and food and feeding stuffs associated with the intended uses of the active substance

EFFECT ON HUMAN AND ANIMAL HEALTH

Medical data

Medical surveillance on manufacturing plant personnel

Sensitisation/allergenicity observations

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

Sensitisation

Acute oral toxicity, pathogenicity and infectiveness

Acute inhalatory toxicity, pathogenicity and infectiveness

Intraperitoneal/subcutaneous single dose

In vitro genotoxicity testing

Cell culture study

Information on short-term toxicity and pathogenicity

Health effects after repeated inhalatory exposure

Proposed treatment: first aid measures, medical treatment

Specific toxicity, pathogenicity and infectiveness studies

Genotoxicity — in vivo studies in somatic cells

Genotoxicity — in vivo studies in germ cells

Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation

Residues in or on treated articles, food and feedingstuffs

Persistence and likelihood of multiplication in or on treated articles, feedingstuffs or foodstuffs

Further information required

Non-viable residues

Viable residues

Summary and evaluation of residues in or on treated articles, food and feedingstuffs

EFFECTS ON NON-TARGET ORGANISMS

Effects on fish

Effects on freshwater invertebrates

Effects on algae growth

Effects on plants other than algae

Effects on earthworms

Effects on soil micro-organisms

Effects on birds

Effects on bees

Effects on arthropods other than bees

Further studies

Terrestrial plants

Mammals

Other relevant species and processes

Summary and evaluation of effects on non-target organisms

Soil

Water

Air

Mobility

Summary and evaluation of fate and behaviour in the environment

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

Emergency measures in case of an accident

Procedures for destruction or decontamination

Procedures for waste management

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

Relevant risk group specified in Article 2 of Directive 2000/54/EC

The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed