‘Table of contents

INTRODUCTION TO PART B

1.

Identity of the applicant, identity of the plant protection product and manufacturing information

1.1.

Applicant

1.2.

Producer of the preparation and the micro-organism(s)

1.3.

Trade name or proposed trade name, and producer’s development code number of the preparation if appropriate

1.4.

Detailed quantitative and qualitative information on the composition of the preparation

1.5.

Physical state and nature of the preparation

1.6.

Method of production of the preparation and quality control

1.7.

Packaging and compatibility of the preparation with proposed packaging materials

2.

Physical, chemical and technical properties of the plant protection product

2.1.

Appearance (colour and odour)

2.2.

Explosivity and oxidising properties

2.3.

Flash point and other indications of flammability or spontaneous ignition

2.4.

Acidity, alkalinity and if necessary pH value

2.5.

Viscosity and surface tension

2.6.

Storage stability and shelf life

2.6.1.

Use concentration

2.6.2.

Effects of temperature and packaging

2.6.3.

Other factors affecting stability

2.7.

Technical characteristics of the plant protection product

2.7.1.

Wettability

2.7.2.

Persistent foaming

2.7.3.

Suspensibility, spontaneity of dispersion and dispersion stability

2.7.4.

Dry sieve test and wet sieve test

2.7.5.

Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)

2.7.6.

Emulsifiability, re-emulsifiability and emulsion stability

2.7.7.

Flowability, pourability (rinsability) and dustability

2.8.

Physical and chemical compatibility with other plant protection products including plant protection products with which its use is to be authorised

2.8.1.

Physical compatibility

2.8.2.

Chemical compatibility

2.9.

Adherence and distribution to seeds

3.

Data on application

3.1.

Field of use envisaged

3.2.

Mode of action on the target organism

3.3.

Function, target organisms and plants or plants products to be protected and possible risk mitigation measures

3.4.

Application rate

3.5.

Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed)

3.6.

Method of application

3.7.

Number and timing of applications on the same crop, duration of protection and waiting period(s)

3.8.

Proposed instructions for use

3.9.

Safety intervals and other precautions to protect human health, animal health and the environment

4.

Further information on the plant protection product

4.1.

Procedures for cleaning and decontaminating of application equipment

4.2.

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

4.3.

Measures in case of accident

4.4.

Procedures for destruction or decontamination of the plant protection product and its packaging

4.4.1.

Controlled incineration

4.4.2.

Others

5.

Analytical methods

5.1.

Methods for the analysis of the preparation

5.2.

Methods to determine and quantify residues

6.

Efficacy data

6.1.

Preliminary tests

6.2.

Minimum effective dose

6.3.

Testing effectiveness

6.4.

Information on possible development of resistance in target organisms

6.5.

Adverse effects on treated crops

6.5.1.

Phytotoxicity to target plants (including different cultivars), or to target plant products

6.5.2.

Effects on the yield of treated plants or plant products

6.5.3.

Effects on the quality of plants or plant products

6.5.4.

Effects on transformation processes

6.5.5.

Impact on treated plants or plant propagating material

6.6.

Observations on undesirable or unintended side-effects on succeeding crops and other plants

6.6.1.

Impact on succeeding crops

6.6.2.

Impact on other plants, including adjacent crops

6.7.

Compatibility in plant protection programmes

7.

Effect on human health

7.1.

Medical data

7.2.

Assessment of potential toxicity of the plant protection product

7.3.

Acute toxicity

7.3.1.

Acute oral toxicity

7.3.2.

Acute dermal toxicity

7.3.3.

Acute inhalation toxicity

7.3.4.

Skin irritation

7.3.5.

Eye irritation

7.3.6.

Skin sensitisation

7.4.

Additional toxicity information

7.5.

Data on exposure

7.6.

Available toxicological data relating to non-active substances

7.7.

Supplementary studies for combinations of plant protection products

8.

Residues in or on treated products, food and feed

9.

Fate and behaviour in the environment

10.

Effects on non-target organisms

10.1.

Effects on terrestrial vertebrates

10.2.

Effects on aquatic organisms

10.2.1.

Effects on fish

10.2.2.

Effects on aquatic invertebrates

10.2.3.

Effects on algae

10.2.4.

Effects on aquatic macrophytes

10.3.

Effects on bees

10.4.

Effects on non-target arthropods other than bees

10.5.

Effects on non-target meso- and macroorganisms in soil

10.6.

Effects on non-target terrestrial plants

10.7.

Additional toxicity studies’.