Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

ANNEX IVB DATA SET FOR BIOCIDAL PRODUCTSFUNGI, MICRO-ORGANISMS AND VIRUSES

1. Dossiers on biocidal products are required to address at least all the points listed under ‘Dossier requirements’. 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.

3. Information may be derived from existing data where a justification acceptable to the competent authority is provided. In particular, the provisions of Directive 88/379/EEC should be used wherever possible to minimise animal testing.

Dossier requirements

I.

Applicant

II.

Identity and composition of the biocidal product

III.

Technical properties of the biocidal product and any biocidal properties additional to those of the active organism

IV.

Methods for identification and analysis of the biocidal product

V.

Intended uses and efficacy for those uses

VI.

Toxicological information (additional to that for the active organism)

VII.

Ecotoxicological information (additional to that for the active organism)

VIII.

Measures to be adopted to protect humans, non-target organisms and the environment

IX.

Classification, packaging and labelling of the biocidal product

X.

Summary of Sections II to IX

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

I. APPLICANT

1.1. Name and address, etc.

1.2. Manufacturers of biocidal products and active organisms including location of plants

II. IDENTITY OF BIOCIDAL PRODUCT

2.1. Trade name or proposed trade name and manufacturer's development code number for biocidal product, if appropriate

2.2. Detailed quantitative and qualitative information on the composition of the biocidal product (active organisms, inert components, extraneous organisms, etc.)

2.3. Physical state and nature of the biocidal product (emulsifiable concentrate, wettable powder, etc.)

2.4. Concentration of active organism in material used

III. TECHNICAL AND BIOLOGICAL PROPERTIES

3.1. Appearance (colour and odour)

3.2. Storage — stability and shelf-life. Effects of temperature, method of packaging and storage, etc. on retention of biological activity

3.3. Methods for establishing storage and shelf-life stability

3.4. Technical characteristics of the biocidal product

3.4.1. Wettability

3.4.2. Persistent foaming

3.4.3. Suspensibility and suspension stability

3.4.4. Wet sieve test and dry sieve test

3.4.5. Particle size distribution, content of dust/fines, attrition and friability

3.4.6. In the case of granules, sieve test and indications of weight distribution of the granules, at least of the fraction with particle sizes bigger than 1 mm

3.4.7. Content of active substance in or on bait particles, granules or treated material

3.4.8. Emulsifiability, re-emulsifiability, emulsion stability

3.4.9. Flowability, pourability and dustability

3.5. Physical and chemical compatibility with other products including biocidal products with which its use is to be authorised

3.6. Wetting, adherence and distribution following application

3.7. Any changes to biological properties of the organism is a result of formulation. In particular changes in pathogenicity on infectivity

IV. METHOD FOR IDENTIFICATION AND ANALYSIS

4.1. Analytical methods for determining the composition of the biocidal product

4.2. Methods for determining residues (e.g. biotest)

4.3. Methods used to show microbiological purity of the biocidal product

4.4. Methods used to show the biocidal product to be free from any human and other mammalian pathogens or, if need be, from pathogens harmful to non-target organisms and the environment

4.5. Techniques used to ensure a uniform product and assay methods for its standardisation

V. INTENDED USES AND EFFICACY FOR THESE USES

5.1. Use

Product-type (e.g. wood preservative, insecticide, etc.)

5.2. Details of intended use, (e.g. types of harmful organism controlled, materials to be treated, etc.)

5.3. Application rate

5.4. Where necessary, in the light of the test results, any specific circumstances or environmental conditions under which the product may or may not be used

5.5. Method of application

5.6. Number and timing of applications

5.7. Proposed instructions for use

Efficacy data

5.8. Preliminary range-finding tests

5.9. Field experimentation

5.10. Information on the possible occurrence of the development of resistance

5.11. Effects on the quality of materials or products treated

VI. TOXICITY INFORMATION ADDITIONAL TO THAT REQUIRED FOR THE ACTIVE ORGANISM

6.1. Oral single dose

6.2. Percutaneous single dose

6.3. Inhalation

6.4. Skin and where relevant eye irritation

6.5. Skin sensitisation

6.6. Available toxicological data relating to non-active substances

6.7. Operator exposure

6.7.1. Percutaneous absorption/inhalation depending on formulation and method of application

6.7.2. Likely operator exposure under field conditions, including where relevant quantitative analysis of operator exposure

VII. ECOTOXICITY INFORMATION ADDITIONAL TO THAT REQUIRED FOR THE ACTIVE ORGANISM

7.1. Observations concerning undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms or persistence in the environment

VIII. MEASURES TO BE ADOPTED TO PROTECT MAN, NON-TARGET ORGANISMS AND THE ENVIRONMENT

8.1. Recommended methods and precautions concerning handling, storage, transport and use

8.2. Re-entry periods, necessary waiting periods or other precautions to protect humans and animals

8.3. Emergency measures in case of an accident

8.4. Procedures for destruction or decontamination of the biocidal product and its packaging

IX. CLASSIFICATION, PACKAGING AND LABELLING

9.1. Proposals including justification for the classification, packaging and labelling

I.

With regard to non-biological components of the product in accordance with Directive 88/379/EEC

• Hazard symbol(s)

• Indications of danger

• Risk phrases

• Safety phrases

II.

With regard to the active organisms labelling with the appropriate risk group as outlined in Article 2(d) of Directive 90/679/EEC together with the biohazard sign specified in that Directive if appropriate

9.2. Packaging (type, materials, size, etc.), compatibility of the biocidal product with proposed packaging materials

9.3. Specimens of proposed packaging

X. SUMMARY OF SECTIONS II to IX