1.<Strong>Identity of the plant protection product</Strong>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.<Emphasis>Applicant (name and address, etc.)</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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1.2.<Emphasis>Manufacturer of the preparation and the active substance(s) (names and addresses etc. including location of plants)</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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1.3.<Emphasis>Trade name or proposed trade name, and manufacturer’s development code number of the preparation if appropriate</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.<Emphasis>Detailed quantitative and qualitative information on the composition of the preparation (active substance(s), and co-formulants)</Emphasis>1.4.1.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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1.4.2.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.3.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.4.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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1.5.<Emphasis>Physical state and nature of the preparation (emulsifiable concentrate, wettable powder, solution, etc.)</Emphasis>1.5.1.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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1.6.<Emphasis>Function (herbicide, insecticide, etc.)</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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3.<Strong>Data on application</Strong>3.1.<Emphasis>Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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3.2.<Emphasis>Effects on harmful organisms, e.g. contact, inhalation or stomach poison, fungitoxic or fungistatic, etc. systemic or not in plants</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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3.3.<Emphasis>Details of intended use, e.g. types of harmful organisms controlled and/or plants or plant products to be protected</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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3.4.<Emphasis>Application rate</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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3.5.<Emphasis>Concentration of active substance in material used (e.g. in the diluted spray, baits or treated seed)</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.6.<Emphasis>Method of application</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.7.<Emphasis>Number and timing of applications and duration of protection</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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3.8.<Emphasis>Necessary waiting periods or other precautions to avoid phytotoxic effects on succeeding crops</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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3.9.<Emphasis>Proposed instructions for use</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.<Strong>Further information on the plant protection product</Strong>4.1.<Emphasis>Packaging (type, materials, size, etc.), compatibility of the preparation with proposed packaging materials</Emphasis>4.1.1.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1.2.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1.3.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2.<Emphasis>Procedures for cleaning application equipment</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3.<Emphasis>Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3.1.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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4.3.2.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.4.<Emphasis>Recommended methods and precautions concerning: handling, storage, transport or fire</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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4.5.<Emphasis>Emergency measures in the case of an accident</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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4.6.<Emphasis>Procedures for destruction or decontamination of the plant protection product and its packaging</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.6.1.<Expanded>Possibility of neutralisation</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.6.2.<Expanded>Controlled incineration</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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4.6.3.<Expanded>Others</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.<Strong>Analytical methods</Strong><Emphasis>Introduction</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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5.1.<Emphasis>Methods for the analysis of the preparation</Emphasis>5.1.1.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.2.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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5.1.3.<Expanded>Specificity, linearity, accuracy and repeatability</Expanded>5.1.3.1.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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5.1.3.2.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.3.3.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.3.4.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.<Emphasis>Analytical methods for the determination of residues</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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6.<Strong>Efficacy data</Strong><Emphasis>General</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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6.1.<Emphasis>Preliminary tests</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2.<Emphasis>Testing effectiveness</Emphasis><Expanded>Aim of the tests</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Test conditions</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Expanded>Test guideline</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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6.3.<Emphasis>Information on the occurrence or possible occurrence of the development of resistance</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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6.4.<Emphasis>Effects on the yield of treated plants or plant products in terms of quantity and/or quality</Emphasis>6.4.1.<Expanded>Effects on the quality of plants or plant products</Expanded><Emphasis><Expanded>Aim of the tests</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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6.4.2.<Expanded>Effects on transformation processes</Expanded><Emphasis><Expanded>Aim of the tests</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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6.4.3.<Expanded>Effects on the yield of treated plants or plant products</Expanded><Emphasis><Expanded>Aim of the tests</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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6.5.<Emphasis>Phytotoxicity to target plants (including different cultivars), or to target plant products</Emphasis><Expanded>Aim of the tests</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Circumstances in which required</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Expanded>Test guideline</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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6.6.<Emphasis>Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms, on succeeding crops, other plants or parts of treated plants used for propagating purposes (e.g. seeds, cuttings, runners)</Emphasis>6.6.1.<Expanded>Impact on succeeding crops</Expanded><Emphasis><Expanded>Aim of the information required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.2.<Expanded>Impact on other plants, including adjacent crops</Expanded><Emphasis><Expanded>Aim of the information required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.3.<Expanded>Impact on treated plants or plant products to be used for propagation</Expanded><Emphasis><Expanded>Aim of the information required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test guideline</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.4.<Expanded>Effects on beneficial and other non-target organisms</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7.<Emphasis>Summary and evaluation of data presented under 6.1 to 6.6</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.<Strong>Toxicological studies</Strong>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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7.1.<Emphasis>Acute toxicity</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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7.1.1.<Expanded>Oral</Expanded><Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test method</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1.2.<Expanded>Percutaneous</Expanded><Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test method</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1.3.<Expanded>Inhalation</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test method</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1.4.<Expanded>Skin irritation</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test method</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1.5.<Expanded>Eye irritation</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test method</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1.6.<Expanded>Skin sensitisation</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test method</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1.7.<Expanded>Supplementary studies for combinations of plant protection products</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2.<Emphasis>Data on exposure</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2.1.<Expanded>Operator exposure</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2.1.1.<Emphasis><Expanded>Estimation of operator exposure</Expanded></Emphasis>Aim of the estimation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Circumstances in which required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Estimation conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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7.2.1.2.<Emphasis><Expanded>Measurement of operator exposure</Expanded></Emphasis>Aim of the test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Circumstances in which required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Test conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2.2.<Expanded>Bystander exposure</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Aim of the estimation</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Estimation conditions</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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7.2.3.<Expanded>Worker exposure</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2.3.1.<Emphasis><Expanded>Estimation of worker exposure</Expanded></Emphasis>Aim of the estimation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Circumstances in which required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Estimation conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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7.2.3.2.<Emphasis><Expanded>Measurement of worker exposure</Expanded></Emphasis>Aim of the test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Circumstances in which required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Test conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.3.<Emphasis>Dermal absorption</Emphasis><Expanded>Aim of the test</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Circumstances in which required</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Expanded>Test conditions</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Test guideline</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.4.<Emphasis>Available toxicological data relating to non-active substances</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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8.<Strong>Residues in or on treated products, food and feed</Strong><Emphasis>Introduction</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.1.<Emphasis>Metabolism, distribution and expression of residue in plants or livestock</Emphasis><Expanded>Aim of the tests</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Expanded>Circumstances in which required</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Test conditions</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.2.<Emphasis>Residue trials</Emphasis><Expanded>Aim of the tests</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Expanded>Circumstances in which required</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Test conditions</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.3.<Emphasis>Livestock feeding studies</Emphasis><Expanded>Aim of the tests</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Circumstances in which required</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Test conditions</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.4.<Emphasis>Effects of industrial processing and/or household preparations</Emphasis><Expanded>Aim of the tests</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Expanded>Circumstances in which required</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Test conditions</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.5.<Emphasis>Residues in succeeding crops</Emphasis><Expanded>Aim of the test</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Circumstances in which required</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Test conditions</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.6.<Emphasis>Proposed maximum residue levels (MRLs) and residue definition</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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8.7.<Emphasis>Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses.</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.8.<Emphasis>Estimation of the potential and actual exposure through diet and other means</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.9.<Emphasis>Summary and evaluation of residue behaviour</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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10.<Strong>Ecotoxicological studies</Strong><Emphasis>Introduction</Emphasis>(i). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(ii)In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, shall be sufficient to:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(iii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(iv)In general, much of the data relating to impact on non-target species, required for authorisation of plant protection products, will have been submitted and evaluated for the approval of the active substance. The information on fate and behaviour in the environment, generated and submitted in accordance with points 9.1 to 9.3, and on residue levels in plants generated and submitted in accordance with point 8 is central to the assessment of impact on non-target species, in that it provides information on the nature and extent of potential or actual exposure. The final PEC estimations are to be adapted in accordance with the different groups of organisms taking in particular into consideration the biology of the most sensitive species.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(v). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(vi). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(vii)Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 of this Annex shall be used.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(viii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(ix). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1.<Emphasis>Effects on birds</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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10.1.1.<Expanded>Acute oral toxicity</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test conditions</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1.2.<Expanded>Supervised cage or field trials</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test conditions</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1.3.<Expanded>Acceptance of bait, granules or treated seeds by birds</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1.4.<Expanded>Effects of secondary poisoning</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.2.<Emphasis>Effects on aquatic organisms</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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10.2.1.<Expanded>Acute toxicity to fish, aquatic invertebrates or effects on algal growth</Expanded><Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test conditions and test guidelines</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.2.2.<Expanded>Microcosm or mesocosm study</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test conditions</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test guideline</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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10.2.3.<Expanded>Residue data in fish</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test guideline</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.2.4.<Expanded>Additional studies</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.3.<Emphasis>Effects on terrestrial vertebrates other than birds</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Expanded>Aim of the test</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Expanded>Circumstances in which required</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Expanded>Test conditions</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.4.<Emphasis>Effects on bees</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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10.4.1.<Expanded>Acute oral and contact toxicity</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test guideline</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.4.2.<Expanded>Residue test</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test conditions</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.4.3.<Expanded>Cage tests</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test conditions</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test guideline</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.4.4.<Expanded>Field tests</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test conditions</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test guideline</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.4.5.<Expanded>Tunnel tests</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test conditions</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test guideline</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.5.<Emphasis>Effects on arthropods other than bees</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.5.1.<Expanded>Laboratory, extended laboratory and semi-field tests</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test conditions</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test guideline</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.5.2.<Expanded>Field tests</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test conditions</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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<Emphasis><Expanded>Test guideline</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.6.<Emphasis>Effects on earthworms and other soil non-target macro-organisms, believed to be at risk</Emphasis>10.6.1.<Expanded>Effects on earthworms</Expanded>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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10.6.1.1.<Emphasis><Expanded><Emphasis>Acute toxicity tests</Emphasis></Expanded></Emphasis>Aim of the test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Circumstances in which required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Test guideline. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.6.1.2.<Emphasis><Expanded>Tests for sublethal effects</Expanded></Emphasis>Aim of the test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Circumstances in which required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Test conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.6.1.3.<Emphasis><Expanded>Field studies</Expanded></Emphasis>Aim of the test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Circumstances in which required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Test conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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10.6.2.<Expanded>Effects on other soil non-target macro-organisms</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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10.7.<Emphasis>Effects on soil non-target micro-organisms</Emphasis>10.7.1.<Expanded>Laboratory testing</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Test guideline</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.7.2.<Expanded>Additional testing</Expanded><Emphasis><Expanded>Aim of the test</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
<Emphasis><Expanded>Circumstances in which required</Expanded></Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.8.<Emphasis>Available data from biological primary screening in summary form</Emphasis>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .