Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

ANNEX IVA DATA SET FOR ACTIVE SUBSTANCESFUNGI, MICRO-ORGANISMS AND VIRUSES

1. Dossiers on active organisms are required to address at least all the points listed under ‘Dossier requirements’ below. Responses are required to be supported by data. The dossier requirements must be in line with technical development.

2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases, a justification, acceptable to the competent authority must be submitted. Such a justification may be the existence of a frame-formulation to which the applicant has the right of access.

Dossier requirements

I.

Applicant details

II.

Identity of the active organism

III.

Source of active organism

IV.

Methods of detection and identification

V.

Biological properties of active organism including pathogenicity and infectivity for target and non-target organisms including man

VI.

Effectiveness and intended uses

VII.

Toxicological profile for man and animals including metabolism of toxins

VIII.

Ecotoxicological profile including environmental fate and behaviour of the organisms and of toxins it produces

IX.

Measures necessary to protect man, non-target organisms and the environment

X.

Classification and labelling

XI.

Summary and evaluation of Sections II to X

The following data will be required to support submissions on the above points.

I. APPLICANT

1.1. Applicant (name, address, etc.)

1.2. Manufacturer (name, address, plant location)

II. IDENTITY OF THE ORGANISM

2.1. Common name of organism (including alternative and superseded names)

2.2. Taxonomic name and strain indicating whether it is a stock variant or a mutant strain; for viruses, taxonomic designation of the agent, serotype, strain or mutant

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 organism (e.g. morphology, biochemistry, serology, etc.)

III. SOURCE OF THE ORGANISM

3.1. Occurrence in nature or otherwise

3.2. Isolation methods for organism or active strain

3.3. Culture methods

3.4. Production methods including details of containment and procedure to maintain quality and ensure a uniform source of active organism. For mutant strains detailed information should be provided on production and isolation, together with all known differences between the mutant strains and parent and naturally occurring strains

3.5. Composition of the final active organism material i.e. nature, purity, identity, properties, content of any impurities and extraneous organisms

3.6. Methods to prevent contamination of seed stock and loss of virulence of seed stock

3.7. Procedures for waste management

IV. METHODS OF DETECTION AND IDENTIFICATION

4.1. Methods for establishing the presence and identity of the organism

4.2. Methods for establishing the identity and purity of seed stock from which batches are produced and results obtained, including information on variability

4.3. Methods to show the microbiological purity of the final product and showing that contaminants have been controlled to an acceptable level, the results obtained and information on variability

4.4. Methods used to show that there are no human or other mammalian pathogens as contaminants in the active agent, including in the case of protozoa and fungi, the effects of temperature (35 ^oC and other relevant temperatures)

4.5. Methods to determine viable and non-viable (e.g. toxins) residues in or on treated products, foodstuffs, feedingstuffs, animal and human body fluids and tissues, soil, water and air, where relevant

V. BIOLOGICAL PROPERTIES OF THE ORGANISM

5.1. History of the organism and its uses including as far as is known its general natural history and, if relevant, its geographical distribution

5.2. Relationship to existing pathogens of vertebrates, invertebrates, plants or other organisms

5.3. Effects on target organism. Pathogenicity or kind of antagonism to the host. Details of host specificity range should be included

5.4. Transmissibility, infective dose and mode of action including information on presence, absence or production of toxins with, if appropriate, information on their nature, identity, chemical structure and stability and potency

5.5. Possible effects on non-target organisms closely related to the target organism including infectivity, pathogenicity, and transmissibility

5.6. Transmissibility to other non-target organisms

5.7. Any other biological effects on non-target organisms when properly used

5.8. Infectivity and physical stability when properly used

5.9. Genetic stability under environmental conditions of proposed use

5.10. Any pathogenicity and infectivity to man and animals under conditions of immunosuppression

5.11. Pathogenicity and infectivity for known parasites/predators of the target species

VI. EFFECTIVENESS AND INTENDED USES

6.1. Harmful organisms controlled and materials, substances, organisms or products to be treated or protected

6.2. Uses envisaged (e.g. insecticide, disinfectant, anti-fouling product, etc.)

6.3. Information or observations on undesirable or unintended side effects

6.4. Information on the occurrence or possible occurrence of the development of resistance and possible management strategies to deal with this

6.5. Effects on target organisms

6.6. Category of user

VII. TOXICOLOGICAL AND METABOLIC STUDIES

7.1. Acute toxicity

In cases where a single dose is not appropriate, a set of range finding tests must be carried out to reveal highly toxic agents and infectivity

1.

oral

2.

dermal

3.

inhalation

4.

skin and where necessary eye irritation

5.

skin sensitisation and, where necessary, respiratory sensitisation and

6.

for viruses and viroids, cell culture studies using purified infective virus and primary cell cultures of mammalian, avian and fish cells

7.2. Sub-chronic toxicity

40-day study, two species, one rodent, one non-rodent

1.

oral administration

2.

other routes (inhalation, dermal) as appropriate and

3.

for viruses and viroids test for infectivity carried out by bio assay or on a suitable cell culture at least seven days after administration to test animals

7.3. Chronic toxicity

Two species, rodent and one other mammal, oral administration unless another route is more appropriate

7.4. Carcinogenicity study

May be combined with studies in 6.3. One rodent and one other mammal

7.5. Mutagenicity studies

As specified in Annex IIA, Section VI, part 6.6

7.6. Reproductive toxicity

Teratogenicity test — rabbit and one rodent species. Fertility study — one species, minimum of two generations, male and female

7.7. Metabolism studies

Basic toxicokinetics, absorption (including dermal absorption) distribution and excretion in mammals including elucidation of metabolic pathways

7.8. Neurotoxicity studies: required where there is any indication of anticholinerterase activity or other neurotoxic effects. Delayed neurotoxicity tests using adult hens should be performed where appropriate

7.9. Immunotoxicity studies (e.g. allergenicity)

7.10. Incidental exposure studies: required where the active substance will be in products for use where human food or animal feedingstuffs are prepared, consumed or stored and where humans, livestock or pets are likely to be exposed to treated areas or materials

7.11. Human exposure data including:

1.

Medical data in anonymous form (if available)

2.

Health records, medical surveillance data on manufacturing plants personnel (if available)

3.

Epidemiological data (if available)

4.

Poisoning incidents data

5.

Poisoning diagnosis (signs, symptoms) including details of any analytical tests

6.

Proposed treatment of poisoning and prognoses

7.12. Summary of mammalian toxicology — conclusions (including NOAEL, NOEL and if appropriate ADI), overall evaluation with regard to all toxicological, pathogenicity and infectivity data and any other information concerning the active organism. Where possible suggested user protection measures should be included in summary form

VIII. ECOTOXICOLOGICAL STUDIES

8.1. Acute toxicity to fish

8.2. Acute toxicity to Daphnia magna

8.3. Effects on algae growth (inhibition test)

8.4. Acute toxicity on one other, non-aquatic, non-target organism

8.5. Pathogenicity and infectivity for honeybees and earthworms

8.6. Acute toxicity and/or pathogenicity and infectivity for other non-target organisms believed to be at risk

8.7. Effects (if any) on other flora and fauna

8.8. In cases where toxins are produced, data as outlined in Annex IIA, Section VII, parts 7.1 to 7.5 should be produced

Fate and behaviour in the environment

8.9. Spread, mobility, multiplication and persistence in air, soil and water

8.10. In cases where toxins are produced, data as outlined in Annex IIA, Section VII, parts 7.6 to 7.8

IX. MEASURES NECESSARY TO PROTECT HUMANS, NON-TARGET ORGANISMS AND THE ENVIRONMENT

9.1. Methods and precautions to be taken for storage, handling, transport and use; or in the event of fire or other likely incident

9.2. Any circumstances or environmental conditions under which the active organism should not be used

9.3. The possibility of rendering the active organism non-infective and any method for doing this

9.4. Consequences of the contamination of air, soil and water, particularly drinking water

9.5. Emergency measures in case of accident

9.6. Procedures for waste management of the active organism including leachate qualities on disposal

9.7. Possibility of destruction or decontamination following release in or into the following: air, water, soil, others if appropriate

X. CLASSIFICATION AND LABELLING

Proposals for allocation to one of the risk groups outlined in Article 2(d) of Directive 90/679/EEC with justifications for the proposal together with indications on the need for products to carry the biohazard sign specified in Annex II to Directive 90/679/EEC

XI. SUMMARY AND EVALUATION OF SECTIONS II TO X