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Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

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  1. Introductory Text

  2. Scope

    1. Article 1.(1) This Directive concerns the authorization, placing on the market,...

  3. Definitions

    1. Article 2.For the purposes of this Directive the following definitions shall...

  4. General provisions

    1. Article 3.(1) Member States shall prescribe that plant protection products may...

  5. Packaging and labelling of plant protection products

    1. Article 15.Article 5 (1) of Directive 78/631/EEC shall apply to all...

    2. Article 16.Member States shall take all necessary measures to ensure that...

  6. Control measures

    1. Article 17.Member States shall make the necessary arrangements for plant protection...

  7. Administrative provisions

    1. Article 18.(1) The Council, acting by a qualified majority on a...

    2. Article 19.(1) The Commission shall be assisted by the Standing Committee...

    3. Article 20.(1) The Commission shall be assisted by the Standing Committee...

    4. Article 21.(1) The Commission shall be assisted by the Standing Committee...

  8. Research and development

    1. Article 22.(1) The Member States shall prescribe that any experiment or...

  9. Implementation of the Directive

    1. Article 23.(1) Member States shall bring into force the laws, regulations...

    2. Article 24.This Directive is addressed to the Member States.

    1. ANNEX I

    2. ANNEX II

      REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE INCLUSION OF AN ACTIVE SUBSTANCE IN ANNEX I

      1. INTRODUCTION

        1. 1.1. include a technical dossier supplying the information necessary for evaluating...

        2. 1.2. where relevant, be generated using test guidelines, according to the...

        3. 1.3. in the event of a test guideline being inappropriate or...

        4. 1.4. include, when required by the competent authority, a full description...

        5. 1.5. include a full and unbiased report of the studies conducted...

        6. 1.6. where relevant, have been generated in accordance with the requirements...

        7. 2.1. Tests and analyses must be conducted in accordance with the...

        8. 2.2. By way of derogation from point 2.1, Member States may...

        9. 2.3. By way of derogation from point 2.1, Member States may...

        10. 2.4. By way of derogation from point 2.1, for active substances...

      2. PART A Chemical substances

        1. 1. Identity of the active substance

          1. 1.1. Applicant (name, address, etc.)

          2. 1.2. Manufacturer (name, address, including location of plant)

          3. 1.3. Common name proposed or ISO-accepted, and synonyms

          4. 1.4. Chemical name (IUPAC and CA nomenclature)

          5. 1.5. Manufacturer's development code number(s)

          6. 1.6. CAS, EEC and CIPAC numbers (if available)

          7. 1.7. Molecular and structural formula, molecular mass

          8. 1.8. Method of manufacture (synthesis pathway) of the active substance

          9. 1.9. Specification of purity of the active substance in g/kg

          10. 1.10. Identity of isomers, impurities and additives (e.g. stabilizers), together with...

          11. 1.11. Analytical profile of batches

        2. 2. Physical and chemical properties of the active substance

          1. 2.1. Melting point and boiling point

            1. 2.1.1. The melting point or where appropriate the freezing or solidification...

            2. 2.1.2. Where appropriate the boiling point of purified active substances must...

            3. 2.1.3. Where melting point and/or boiling point cannot be determined because...

          2. 2.2. Relative density

          3. 2.3. Vapour pressure (in Pa), volatility (e.g. Henry's law constant)

            1. 2.3.1. The vapour pressure of purified active substance must be reported...

            2. 2.3.2. In the case of active substances which are solids or...

          4. 2.4. Appearance (physical state, colour and odour; if known)

            1. 2.4.1. A description of both the colour, if any, and the...

            2. 2.4.2. A description of any odour associated with the active substance...

          5. 2.5. Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths...

            1. 2.5.1. The following specta including a table of signal characteristica needed...

            2. 2.5.2. The UV/visible absorption spectra, IR, NMR and MS spectra, where...

          6. 2.6. Solubility in water including effect of pH (4 to 10)...

          7. 2.7. Solubility in organic solvents

          8. 2.8. Partition coefficient n-octanol/water including effect of pH (4 to 10)...

          9. 2.9. Stability in water, hydrolysis rate, photochemical degradation, quantum yield and...

            1. 2.9.1. The hydrolysis rate of purified active substances (usually radiolabelled active...

            2. 2.9.2. For compounds with a molar (decadic) absorption coefficient (ε) > 10...

            3. 2.9.3. Where necessary to investigate direct phototrans-formation, the quantum yield of...

            4. 2.9.4. Where dissociation in water occurs, the dissociation constant(s) (pKa values)...

          10. 2.10. Stability in air, photochemical degradation, identity of breakdown product(s)

          11. 2.11. Flammability including auto-flammability

            1. 2.11.1. The flammability of active substances as manufactured, which are solids,...

            2. 2.11.2. The auto-flamability of active substances as manufactured must be determined...

          12. 2.12. Flash point

          13. 2.13. Explosive properties

          14. 2.14. Surface tension

          15. 2.15 Oxidizing properties

        3. 3. Further information on the active substance

          1. 3.1. Function, e.g. fungicide, herbicide, insecticide, repellant, growth regulator

          2. 3.2. Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach...

            1. 3.2.1. The nature of the effects on harmful organisms must be...

            2. 3.2.2. It must be stated whether or not the active substance...

          3. 3.3. Field of use envisaged, e.g. field, protected crops, storage of...

          4. 3.4. Harmful organisms controlled and crops or products protected or treated...

            1. 3.4.1. Details of existing and the intended use in terms of...

            2. 3.4.2. Where relevant, details of harmful organisms against which protection is...

            3. 3.4.3 Where relevant, effects achieved e.g. sprout suppression, retardation of ripening,...

          5. 3.5. Mode of action

            1. 3.5.1. To the extent that is has elucidated, a statement must...

            2. 3.5.2. Where it is known that to exert its intended effect,...

            3. 3.5.3. Available information relating to the formation of active metabolites and...

          6. 3.6. Information on the occurrence or possible occurrence of the development...

          7. 3.7. Recommended methods and precautions concerning handling, storage, transport or fire...

          8. 3.8. Procedures for destruction or decontamination

            1. 3.8.1. Controlled incineration

            2. 3.8.2. Others

          9. 3.9. Emergency measures in case of an accident

        4. 4. Analytical methods

          1. Introduction

          2. 4.1. Methods for the analysis of the active substance as manufactured...

            1. 4.1.1. Methods, which must be described in full, must be provided...

            2. 4.1.2. Methods must also be provided for the determination of significant...

            3. 4.1.3. Specificity, linearity, accuracy and repeatability

              1. 4.1.3.1. Specificity of methods submitted, must be demonstrated and reported. In...

              2. 4.1.3.2. The linearity of proposed methods over an appropriate range must...

              3. 4.1.3.3. Accuracy is required for methods for the determination of pure...

              4. 4.1.3.4. For the repeatability in the determination of the pure active...

          3. 4.2. Methods for the determination of residues

            1. 4.2.1. Residues in and/or on plants, plant products, foodstuffs (of plant...

            2. 4.2.2. Residues in soil

            3. 4.2.3. Residues in water (including drinking water, ground water and surface...

            4. 4.2.4. Residues in air

            5. 4.2.5. Residues in body fluids and tissues

        5. 5. Toxicological and metabolism studies

          1. Introduction

          2. 5.1. Studies on absorption, distribution, excretion and metabolism in mammals

            1. Aim of the test:

            2. Circumstances in which required

            3. Test guideline

          3. 5.2. Acute toxicity

            1. 5.2.1. Oral

              1. Circumtances in which required

              2. Test guideline

            2. 5.2.2. Percutaneous

              1. Circumstances in which required

              2. Test guideline

            3. 5.2.3. Inhalation

              1. Circumstances in which required

              2. Test guideline

            4. 5.2.4. Skin irritation

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            5. 5.2.5. Eye irritation

              1. Aim of test

              2. Circumstances in which required

              3. Test guidelines

            6. 5.2.6. Skin sensitization

              1. Aim of test

              2. Circumstances in which required

              3. Test guideline

          4. 5.3. Short-term toxicity

            1. 5.3.1. Oral 28-day study

              1. Circumstances in which required

              2. Test guideline

            2. 5.3.2. Oral 90-day study

              1. Circumstances in which required

              2. Test guidelines

            3. 5.3.3. Other routes

              1. Circumstances in which required

              2. Test guidelines

          5. 5.4. Genotoxicity testing

            1. Aim of the test

            2. 5.4.1. In vitro studies

              1. Circumstances in which required

              2. Test guidelines

            3. 5.4.2. In vivo studies in somatic cells

              1. Circumstances in which required

              2. Test guidelines

            4. 5.4.3. In vivo studies in germ cells

              1. Circumstances in which required

          6. 5.5. Long term toxicity and carcinogenicity

            1. Aim of the test

            2. Circumstances in which required

            3. Test conditions

            4. Test guideline

          7. 5.6. Reproductive toxicity

            1. 5.6.1. Multi-generation studies

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

              4. Supplementary studies

            2. 5.6.2. Developmental toxicity studies

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

          8. 5.7. Delayed neurotoxicity studies

            1. Aim of the test

            2. Circumstances in which required

            3. Test guidelines

          9. 5.8. Other toxicological studies

            1. 5.8.1. Toxicity studies of metabolites as referred to in the introduction...

            2. 5.8.2. Supplementary studies on the active substance

          10. 5.9. Medical data

            1. 5.9.1. Medicinal surveillance on manufacturing plant personnel

            2. 5.9.2. Direct observation, e.g.: clinical cases and poisoning incidents

            3. 5.9.3. Observations on exposure of the general population and epidemiological studies...

            4. 5.9.4. Diagnosis of poisoning (determination of active substance, metabolites), specific signs...

            5. 5.9.5. Proposed treatment: first aid measures, antidotes, medical treatment

            6. 5.9.6. Expected effects of poisoning

          11. 5.10. Summary of mammalian toxicity and overall evaluation

        6. 6. Residues in or on treated products, food and feed

          1. Introduction

          2. 6.1. Metabolism, distribution and expression of residue in plants

            1. Aim of the tests

            2. Circumstances in which required

            3. Test conditions

          3. 6.2. Metabolism, distribution and expression of residue in livestock

            1. Aim of tests

            2. Circumstances in which required

          4. 6.3. Residue trials

            1. Aim of the tests

            2. Circumstances in which required

            3. Test conditions

          5. 6.4. Livestock feeding studies

            1. Aim of the tests

            2. Circumstances in which required

            3. Test conditions

          6. 6.5. Effects of industrial processing and/or household preparations

            1. Circumstances in which required

            2. 6.5.1. Effects on the nature of the residue

              1. Aim of the tests

              2. Test conditions

            3. 6.5.2. Effects on the residue levels

              1. Aim of the tests

              2. Test conditions

          7. 6.6. Residues in succeeding crops

            1. Aim of the test

            2. Circumstances in which required

            3. Test conditions

          8. 6.7. Proposed maximum residue levels (MRLs) and residue definiton

          9. 6.8. Proposed pre-harvest intervals for envisaged uses, or withholding periods or...

          10. 6.9. Estimation of the potential and actual exposure through diet and...

          11. 6.10. Summary and evaluation of residue behaviour

        7. 7. Fate and behaviour in the environment

          1. Introduction

          2. 7.1. Fate and behaviour in soil

            1. 7.1.1. Route and rate of degradation

              1. 7.1.1.1. Route of degradation

                1. 7.1.1.1.1. Aerobic degradation

                2. 7.1.1.1.2. Supplementary studies

              2. 7.1.1.2. Rate of degradation

                1. 7.1.1.2.1. Laboratory studies

                2. 7.1.1.2.2. Field studies

            2. 7.1.2. Adsorption and desorption

            3. 7.1.3. Mobility in the soil

              1. 7.1.3.1. Column leaching studies

              2. 7.1.3.2. Aged residue column leaching

              3. 7.1.3.3. Lysimeter studies or field leaching studies

          3. 7.2. Fate and behaviour in water and air

            1. 7.2.1. Route and rate of degradation in aquatic systemes (as far...

              1. 7.2.1.1. Hydrolytic degradation

              2. 7.2.1.2. Photochemical degradation

              3. 7.2.1.3. Biological degradation

                1. 7.2.1.3.1. ‘ Ready biodegradability ’

                2. 7.2.1.3.2. Water/sediment study

              4. 7.2.1.4. Degradation in the saturated zone

            2. 7.2.2. Route and rate of degradation in air (as far as...

          4. 7.3. Definition of the residue

          5. 7.4. Monitoring data

        8. 8. Ecotoxicological studies

          1. Introduction

          2. Test substance

          3. Test organisms

          4. 8.1. Effects on birds

            1. 8.1.1. Acute oral toxicity

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

            2. 8.1.2. Short-term dietary toxicity

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

            3. 8.1.3. Subchronic toxicity and reproduction

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

          5. 8.2. Effects on aquatic organisms

            1. 8.2.1. Acute toxicity to fish

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

            2. 8.2.2. Chronic toxicity to fish

              1. Circumstances in which required

              2. 8.2.2.1. Chronic toxicity test on juvenile fish

                1. Aim of the test

                2. Test conditions

              3. 8.2.2.2. Fish early life stage toxicity test

                1. Aim of the test

                2. Test guideline

              4. 8.2.2.3. Fish life cycle test

                1. Aim of the test

                2. Test conditions

            3. 8.2.3. Bioconcentration in fish

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            4. 8.2.4. Acute toxicity to aquatic invertebrates

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            5. 8.2.5. Chronic toxicity to aquatic invertebrates

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

            6. 8.2.6. Effects on algal growth

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            7. 8.2.7. Effects on sediment dwelling organisms

              1. Aim of test

              2. Circumstances in which required

              3. Test conditions

            8. 8.2.8. Aquatic plants

          6. 8.3. Effect on arthropods

            1. 8.3.1. Bees

              1. 8.3.1.1. Acute toxicity

                1. Aim of the test

                2. Circumstances in which required

                3. Test guideline

              2. 8.3.1.2. Bee brood feeding test

                1. Aim of the test

                2. Circumstances in which required

                3. Test guideline

            2. 8.3.2. Other arethropods

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

          7. 8.4. Effects on earthworms

            1. 8.4.1. Acute toxicity

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            2. 8.4.2. Sublethal effects

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

          8. 8.5. Effects on soil non-target micro-organisms

            1. Aim of the test

            2. Circumstances in which required

            3. Test conditions

            4. Test guideline

          9. 8.6. Effects on other non-target organisms (flora and fauna) believed to...

          10. 8.7. Effects on biological methods for sewage treatment

        9. 9. Summary and evaluation of points 7 and 8

        10. 10. Proposals including justification for the proposals for the classification and...

        11. 11. A dossier as referred to in Annex III, part A,...

      3. PART B

        1. Introduction

        2. 1. IDENTITY OF THE MICRO-ORGANISM

          1. 1.1. Applicant

          2. 1.2. Producer

          3. 1.3. Name and species description, strain characterisation

          4. 1.4. Specification of the material used for manufacturing of formulated products...

            1. 1.4.1. Content of the micro-organism

            2. 1.4.2. Identity and content of impurities, additives, contaminating micro-organisms

            3. 1.4.3. Analytical profile of batches

        3. 2. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM

          1. 2.1. History of the micro-organism and its uses. Natural occurrence and...

            1. 2.1.1. Historical background

            2. 2.1.2. Origin and natural occurrence

          2. 2.2. Information on target organism(s)

            1. 2.2.1. Description of the target organism(s)

            2. 2.2.2. Mode of action

          3. 2.3. Host specificity range and effects on species other than the...

          4. 2.4. Development stages/life cycle of the micro-organism

          5. 2.5. Infectiveness, dispersal and colonisation ability

          6. 2.6. Relationships to known plant or animal or human pathogens

          7. 2.7. Genetic stability and factors affecting it

          8. 2.8. Information on the production of metabolites (especially toxins)

          9. 2.9. Antibiotics and other anti-microbial agents

        4. 3. FURTHER INFORMATION ON THE MICRO-ORGANISM

          1. Introduction

          2. 3.1. Function

          3. 3.2. Field of use envisaged

          4. 3.3. Crops or products protected or treated

          5. 3.4. Method of production and quality control

          6. 3.5. Information on the occurrence or possible occurrence of the development...

          7. 3.6. Methods to prevent loss of virulence of seed stock of...

          8. 3.7. Recommended methods and precautions concerning handling, storage, transport or fire...

          9. 3.8. Procedures for destruction or decontamination

          10. 3.9. Measures in case of an accident

        5. 4. ANALYTICAL METHODS

          1. Introduction

          2. 4.1. Methods for the analysis of the micro-organism as manufactured

          3. 4.2. Methods to determine and quantify residues (viable or non-viable)

        6. 5. EFFECTS ON HUMAN HEALTH

          1. Introduction

          2. TIER I

            1. 5.1. Basic information

              1. 5.1.1. Medical data

              2. 5.1.2. Medical surveillance on manufacturing plant personnel

              3. 5.1.3. Sensitisation/allergenicity observations, if appropriate

              4. 5.1.4. Direct observation, e.g. clinical cases

            2. 5.2. Basic studies

              1. 5.2.1. Sensitisation

                1. Aim of the test

                2. Circumstances in which required

              2. 5.2.2. Acute toxicity, pathogenicity and infectiveness

                1. 5.2.2.1. Acute oral toxicity, pathogenicity and infectiveness

                  1. Circumstances in which required

                2. 5.2.2.2. Acute inhalation toxicity, pathogenicity and infectiveness

                  1. Circumstances in which required

                3. 5.2.2.3. Intraperitoneal/subcutaneous single dose

                  1. Circumstances in which required

              3. 5.2.3. Genotoxicity testing

                1. Circumstances in which required

                2. Aim of the test

                3. Test conditions

                4. 5.2.3.1. In vitro studies

                  1. Circumstances in which required

              4. 5.2.4. Cell culture study

              5. 5.2.5. Information on short-term toxicity and pathogenicity

                1. Aim of the test

                2. Circumstances in which required

                3. 5.2.5.1. Health effects after repeated inhalatory exposure

                  1. Circumstances in which required

              6. 5.2.6. Proposed treatment: first aid measures, medical treatment

            3. (END OF TIER I)

          3. TIER II

            1. 5.3. Specific toxicity, pathogenicity and infectiveness studies

            2. 5.4. In vivo studies in somatic cells

              1. Circumstances in which required

            3. 5.5. Genotoxicity — In vivo studies in germ cells

              1. Aim of the test and test conditions

              2. Circumstances in which required

            4. (END OF TIER II)

          4. 5.6. Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation...

        7. 6. RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED

          1. Introduction

          2. 6.1. Persistance and likelihood of multiplication in or on crops, feedingstuffs...

          3. 6.2. Further information required

            1. 6.2.1. Non-viable residues

            2. 6.2.2. Viable residues

          4. 6.3. Summary and evaluation of residue behaviour resulting from data submitted...

        8. 7. FATE AND BEHAVIOUR IN THE ENVIRONMENT

          1. Introduction

          2. 7.1. Persistence and multiplication

            1. 7.1.1. Soil

            2. 7.1.2. Water

            3. 7.1.3. Air

          3. 7.2. Mobility

        9. 8. EFFECTS ON NON-TARGET ORGANISMS

          1. Introduction

          2. 8.1. Effects on birds

            1. Aim of the test

          3. 8.2. Effects on aquatic organisms

            1. Aim of the test

            2. 8.2.1. Effects on fish

              1. Aim of the test

            3. 8.2.2. Effects on freshwater invertebrates

              1. Aim of the test

            4. 8.2.3. Effects on algae growth

              1. Aim of the test

            5. 8.2.4. Effects on plants other than algae

              1. Aim of the test

          4. 8.3. Effects on bees

            1. Aim of the test

          5. 8.4. Effects on arthropods other than bees

            1. Aim of the test

          6. 8.5. Effects on earthworms

            1. Aim of the test

          7. 8.6. Effects on non-target soil micro-organisms

          8. 8.7. Additional studies

        10. 9. SUMMARY AND EVALUATION OF ENVIRONMENTAL IMPACT

    3. ANNEX III

      REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE AUTHORIZATION OF A PLANT PROTECTION PRODUCT

      1. INTRODUCTION

        1. 1.1. include a technical dossier supplying the information necessary for evaluating...

        2. 1.2. where relevant, be generated using test guidelines, according to the...

        3. 1.3. in the event of a test guideline being inappropriate or...

        4. 1.4. include when required by the competent authority, a full description...

        5. 1.5. include a full and unbiased report of the studies conducted...

        6. 1.6. where relevant, have been generated in accordance with the requirements...

        7. 2.1. Tests and analyses must be conducted in accordance with the...

        8. 2.2. Tests and analyses, required under the provisions of Section 6...

        9. 2.3. Member States shall require that officially recognized testing facilities and...

        10. 2.4. By way of derogation from point 2.1, Member States may...

        11. 2.5. By way of derogation from point 2.1, Member States may...

        12. 2.6. By way of derogation from point 2.1, for active substances...

        13. 3. The information required shall include the proposed classification and labelling...

        14. 4. In individial cases it may be necessary to require certain...

      2. PART A Chemical preparations

        1. 1. Identity of the plant protection product

          1. 1.1. Applicant (name and address, etc.)

          2. 1.2. Manufacturer of the preparation and the active substance(s) (names and...

          3. 1.3. Trade name or proposed trade name, and manufacturer's development code...

          4. 1.4. Detailed quantitative and qualitative information on the composition of the...

            1. 1.4.1. For preparations the following information must be reported:

            2. 1.4.2. For active substances their ISO common names or proposed ISO...

            3. 1.4.3. Formulants must where possible, be identified both by their chemical...

            4. 1.4.4. For formulants the function must be given:

          5. 1.5. Physical state and nature of the preparation (emulsifiable concentrate, wettable...

            1. 1.5.1. The type and code of preparation must be designated according...

          6. 1.6. Function (herbicide, insecticide, etc.)

        2. 2. Physical, chemical and technical properties of the plant protection product...

          1. 2.1. Appearance (colour and odour)

          2. 2.2. Explosivity and oxidizing properties

            1. 2.2.1. The explosive properties of preparations must be reported according to...

            2. 2.2.2. Oxidizing properties of preparations which are solids must be determined...

          3. 2.3. Flash point and other indications of flammability or spontaneous ignition...

          4. 2.4. Acidity/alkalinity and if necessary pH value

            1. 2.4.1. In the case of preparations which are acidic (pH < 4)...

            2. 2.4.2. Where relevant (if to be applied as aqueous dilution) the...

          5. 2.5. Viscosity and surface tension

            1. 2.5.1. In the case of liquid preparations for Ultra Low Volume...

            2. 2.5.2. For non newtonian liquids the viscosity must be determined and...

            3. 2.5.3. In the case of liquid preparations the surface tension has...

          6. 2.6. Relative density and bulk density

            1. 2.6.1. The relative density of liquid preparations must be determined and...

            2. 2.6.2. The bulk (tap) density of preparations which are powders or...

          7. 2.7. Storage — stability and shelf-life: Effects of light, temperature and...

            1. 2.7.1. The stability of the preparation after storage for 14 days...

            2. 2.7.2. Additionally in the case of liquid preparations, the effect of...

            3. 2.7.3. The shelf life of the preparation at ambient temperature must...

          8. 2.8. Technical characteristics of the plant protection product

            1. 2.8.1. Wettability

            2. 2.8.2. Persistent foaming

            3. 2.8.3. Suspensibility and suspension stability

            4. 2.8.4. Dilution stability

            5. 2.8.5. Dry sieve test and wet sieve test

            6. 2.8.6. Particle size distribution (dustable and wettable powders, granules), content of...

              1. 2.8.6.1. The size distribution of particles in the case of powders,...

              2. 2.8.6.2. The dust content of granular preparations, must be determined and...

              3. 2.8.6.3. The friability and attrition characteristics of granules, must be determined...

            7. 2.8.7. Emulsifiability, Re-emulsifiability, emulsion stability

              1. 2.8.7.1. The emulsifiability, emulsion stability and re-emul-sifiability of preparations which form...

              2. 2.8.7.2. The stability of dilute emulsions and of preparations which are...

            8. 2.8.8. Flowability, pourability (rinsability) and dustability

              1. 2.8.8.1. The flowability of granular preparations must be determined and reported...

              2. 2.8.8.2. The pourability (including rinsed residue) of suspensions (e.g. suspension concentrates,...

              3. 2.8.8.3. The dustability of dustable powders following accelerated storage according 2.7.1...

          9. 2.9. Physical and chemical compatibility with other products including plant protection...

            1. 2.9.1. The physical compatibility of tank mixes must be reported based...

            2. 2.9.2. The chemical compatibility of tank mixes must be determined and...

          10. 2.10. Adherence and distribution to seeds

          11. 2.11. Summary and evaluation of data presented under points 2.1. to...

        3. 3. Data on application

          1. 3.1. Field of use envisaged, e.g. field, protected crops, storage of...

          2. 3.2. Effects on harmful organisms, e.g. contact, inhalation or stomach poison,...

          3. 3.3. Details of intended use e.g. types of harmful organisms controlled...

          4. 3.4. Application rate

          5. 3.5. Concentration of active substance in material used (e.g. in the...

          6. 3.6. Method of application

          7. 3.7. Number and timing of applications and duration of protection

          8. 3.8. Necessary waiting periods or other precautions to avoid phytotoxic effects...

          9. 3.9. Proposed instructions for use

        4. 4. Further information on the plant protection product

          1. 4.1. Packaging (type, materials, size etc.), compatibility of the preparation with...

            1. 4.1.1. Packaging to be used must be fully described and specified...

            2. 4.1.2. The suitability of the packaging, including closures, in terms of...

            3. 4.1.3. The resistance of the packaging material to its contents must...

          2. 4.2. Procedures for cleaning application equipment

          3. 4.3. Re-entry periods, necessary waiting periods or other precautions to protect...

            1. 4.3.1. Where relevant pre-harvest intervals, re-entry periods or withholding periods necessary...

            2. 4.3.2. Where necessary, in the light of the test results, information...

          4. 4.4. Recommended methods and precautions concerning: handling, storage, transport or fire...

          5. 4.5. Emergency measures in the case of an accident

          6. 4.6. Procedures for destruction or decontamination of the plant protection product...

            1. 4.6.1. Possibility of neutralization

            2. 4.6.2. Controlled incineration

            3. 4.6.3. Others

        5. 5. Analytical methods

          1. Introduction

          2. 5.1. Methods for the analysis of the preparation

            1. 5.1.1. Methods, which must be described in full, must be provided...

            2. 5.1.2. Methods must also be provided for the determination in the...

            3. 5.1.3. Specificity, linearity, accuracy and repeatability

              1. 5.1.3.1. Specificity of methods submitted, must be demonstrated and reported. In...

              2. 5.1.3.2. The linearity of proposed methods over an appropriate range, must...

              3. 5.1.3.3. Accuracy will normally only be required for methods for the...

              4. 5.1.3.4. For the repeatability in principle a minimum of five determinations...

          3. 5.2. Analytical methods for the determination of residues

        6. 6. Efficacy data

          1. General

          2. 6.1. Preliminary tests

          3. 6.2. Testing effectiveness

            1. Aim of the tests

            2. Test conditions

            3. Test guideline

          4. 6.3. Information on the occurrence or possible occurrence of the development...

          5. 6.4. Effects on the yield of treated plants or plant products...

            1. 6.4.1. Effects on the quality of plants or plant product

              1. Aim of the tests

              2. Circumstances in which required

            2. 6.4.2. Effects on transformation processes

              1. Aim of the tests

              2. Circumstances in which required

            3. 6.4.3. Effects on the yield of treated plants or plant products...

              1. Aim of the tests

              2. Circumstances in which required

          6. 6.5. Phytotoxicity to target plants (including different cultivars), or to target...

            1. Aim of the tests

            2. Circumstances in which required

            3. Test guideline

          7. 6.6. Observations on undesirable or unintended side-effects, e. g. on beneficial...

            1. 6.6.1. Impact on succeeding crops

              1. Aim of the information required

              2. Circumstances in which required

            2. 6.6.2. Impact on other plants, including adjacent crops

              1. Aim of the information required

              2. Circumstances in which required

            3. 6.6.3. Impact on treated plants or plant products to be used...

              1. Aim of the information required

              2. Circumstances in which required

              3. Test guideline

            4. 6.6.4. Effects on beneficial and other non-target organisms

          8. 6.7. Summary and evaluation of data presented under 6.1 to 6.6...

        7. 7. Toxicological studies

          1. 7.1. Acute toxicity

            1. 7.1.1. Oral

              1. Circumstances in which required

              2. Test guidelines

            2. 7.1.2. Percutaneous

              1. Circumstances in which required

              2. Test guideline

            3. 7.1.3. Inhalation

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            4. 7.1.4. Skin irritation

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            5. 7.1.5. Eye irritation

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            6. 7.1.6. Skin sensitization

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            7. 7.1.7. Supplementary studies for combinations of plant protection products

              1. Aim of the test

          2. 7.2. Data on exposure

            1. 7.2.1. Operator exposure

              1. 7.2.1.1. Estimation of operator exposure

                1. Aim of the estimation

                2. Circumstances in which required

                3. Estimation conditions

              2. 7.2.1.2. Measurement of operator exposure

                1. Aim of the test

                2. Circumstances in which required

                3. Test conditions

            2. 7.2.2. Bystander exposure

              1. Aim of the estimation

              2. Circumstances in which required

              3. Estimation conditions

            3. 7.2.3. Worker exposure

              1. 7.2.3.1. Estimation of worker exposure

                1. Aim of the estimation

                2. Circumstances in which required

                3. Estimation conditions

              2. 7.2.3.2. Measurement of worker exposure

                1. Aim of the test

                2. Circumstances in which required

                3. Test conditions

          3. 7.3. Dermal absorption

            1. Aim of the test

            2. Circumstances in which required

            3. Test conditions

            4. Test guideline

          4. 7.4. Available toxicological data relating to non-active substances

        8. 8. Residues in or on treated products, food and feed

          1. Introduction

          2. 8.1. Metabolism, distribution and expression of residue in plants or livestock...

            1. Aim of the tests

            2. Circumstances in which required

            3. Test conditions

          3. 8.2. Residue trials

            1. Aim of the tests

            2. Circumstances in which required

            3. Test conditions

          4. 8.3. Livestock feeding studies

            1. Aim of the tests

            2. Circumstances in which required

            3. Test conditions

          5. 8.4. Effects of industrial processing and/or household preparations

            1. Aim of the tests

            2. Circumstances in which required

            3. Test conditions

          6. 8.5. Residues in succeeding crops

            1. Aim of the test

            2. Circumstances in which required

            3. Test conditions

          7. 8.6. Proposed maximum residue levels (MRLs) and residue definition

          8. 8.7. Proposed pre-harvest intervals for envisaged uses, or withholding periods or...

          9. 8.8. Estimation of the potential and actual exposure through diet and...

          10. 8.9. Summary and evaluation of residue behaviour

        9. 9. Fate and behaviour in the environment

          1. Introduction

          2. 9.1 Fate and behaviour in soil

            1. 9.1.1. Rate of degradation in soil

              1. 9.1.1.1. Laboratory studies

              2. 9.1.1.2. Field studies

            2. 9.1.2. Mobility in the soil

              1. 9.1.2.1. Laboratory studies

              2. 9.1.2.2. Lysimeter studies or field leaching studies

            3. 9.1.3. Estimation of expected concentrations in soil

          3. 9.2. Fate and behaviour in water

            1. 9.2.1. Estimation of concentrations in groundwater

            2. 9.2.2. Impact on water treatment procedures

            3. 9.2.3. Estimation of concentrations in surface water

          4. 9.3. Fate and behaviour in air

        10. 10. Ecotoxicological studies

          1. Introduction

          2. 10.1. Effects on birds

            1. 10.1.1. Acute oral toxicity

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

            2. 10.1.2. Supervised cage or field trials

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

            3. 10.1.3. Acceptance of bait, granules or treated seeds by birds

              1. Aim of the test

              2. Circumstances in which required

            4. 10.1.4. Effects of secondary poisoning

          3. 10.2. Effects on aquatic organisms

            1. 10.2.1. Acute toxicity to fish, aquatic invertebrates or effects on algal...

              1. Circumstances in which required

              2. Test conditions and test guidelines

            2. 10.2.2. Microcosm or mesocom study

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

            3. 10.2.3. Residue data in fish

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            4. 10.2.4. Additional studies

          4. 10.3. Effects on terrestrial vertebrates other than birds

            1. Aim of the test

            2. Circumstances in which required

            3. Test conditions

          5. 10.4. Effects on bees

            1. 10.4.1. Acute oral and contact toxicity

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            2. 10.4.2. Residue test

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

            3. 10.4.3. Cage tests

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

            4. 10.4.4. Field tests

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

            5. 10.4.5. Tunnel tests

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

          6. 10.5. Effects on arthropods other than bees

            1. 10.5.1. Laboratory, extended laboratory and semi-field tests

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

            2. 10.5.2. Field tests

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

          7. 10.6. Effects on earthworms and other soil non-target macro-organisms, believed to...

            1. 10.6.1. Effects on earthworms

              1. 10.6.1.1. Acute toxicity tests

                1. Aim of the test

                2. Circumstances in which required

                3. Test guideline

              2. 10.6.1.2. Tests for sublethal effects

                1. Aim of the test

                2. Circumstances in which required

                3. Test conditions

              3. 10.6.1.3. Field studies

                1. Aim of the test

                2. Circumstances in which required

                3. Test conditions

            2. 10.6.2. Effects on other soil non-target macro-organisms

              1. Aim of the test

              2. Circumstances in which required

          8. 10.7. Effects on soil non-target micro-organisms

            1. 10.7.1. Laboratory testing

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            2. 10.7.2. Additional testing

              1. Aim of the test

              2. Circumstances in which required

          9. 10.8. Available data from biological primary screening in summary form

        11. 11. Summary and evaluation of points 9 and 10

        12. 12. Further information

          1. 12.1. Information on authorizations in other countries

          2. 12.2. Information on established maximum residue limits (MRL) in other countries...

          3. 12.3. Proposals including justification for the classification and labelling proposed in...

          4. 12.4. Proposals for risk and safety phrases in accordance with Article...

          5. 12.5. Specimens of proposed packaging

      3. PART B

        1. Introduction

        2. 1. IDENTITY OF THE PLANT PROTECTION PRODUCT

          1. 1.1. Applicant

          2. 1.2. Manufacturer of the preparation and the micro-organism(s)

          3. 1.3. Trade name or proposed trade name, and manufacturer's development code...

          4. 1.4. Detailed quantitative and qualitative information on the composition of the...

          5. 1.5. Physical state and nature of the preparation

          6. 1.6. Function

        3. 2. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT...

          1. 2.1. Appearance (colour and odour)

          2. 2.2. Storage stability and shelf-life

            1. 2.2.1. Effects of light, temperature and humidity on technical characteristics of...

            2. 2.2.2. Other factors affecting stability

          3. 2.3. Explosivity and oxidising properties

          4. 2.4. Flash point and other indications of flammability or spontaneous ignition...

          5. 2.5. Acidity, alkalinity and if necessary pH value

          6. 2.6. Viscosity and surface tension

          7. 2.7. Technical characteristics of the plant protection product

            1. 2.7.1. Wettability

            2. 2.7.2. Persistent foaming

            3. 2.7.3. Suspensibility and suspension stability

            4. 2.7.4. Dry sieve test and wet sieve test

            5. 2.7.5. Particle size distribution (dustable and wettable powders, granules), content of...

            6. 2.7.6. Emulsifiability, re-emulsifiability, emulsion stability

            7. 2.7.7. Flowability, pourability (rinsability) and dustability

          8. 2.8. Physical, chemical and biological compatibility with other products including plant...

            1. 2.8.1. Physical compatibility

            2. 2.8.2. Chemical compatibility

            3. 2.8.3. Biological compatibility

          9. 2.9. Adherence and distribution to seeds

          10. 2.10. Summary and evaluation of data presented under points 2.1 to...

        4. 3. DATA ON APPLICATION

          1. 3.1. Field of use envisaged

          2. 3.2. Mode of action

          3. 3.3. Details of intended use

          4. 3.4. Application rate

          5. 3.5. Content of micro-organism in material used (e.g. in the diluted...

          6. 3.6. Method of application

          7. 3.7. Number and timing of applications and duration of protection

          8. 3.8. Necessary waiting periods or other precautions to avoid phytopathogenic effects...

          9. 3.9. Proposed instructions for use

        5. 4. FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT

          1. 4.1. Packaging and compatibility of the preparation with proposed packaging materials...

          2. 4.2. Procedures for cleaning application equipment

          3. 4.3. Re-entry periods, necessary waiting periods or other precautions to protect...

          4. 4.4. Recommended methods and precautions concerning: handling, storage, transport or fire...

          5. 4.5. Measures in the case of an accident

          6. 4.6. Procedures for destruction or decontamination of the plant protection product...

            1. 4.6.1. Controlled incineration

            2. 4.6.2. Others

        6. 5. ANALYTICAL METHODS

          1. Introduction

          2. 5.1. Methods for the analysis of the preparation

          3. 5.2. Methods to determine and quantify residues

        7. 6. EFFICACY DATA

        8. 7. EFFECTS ON HUMAN HEALTH

          1. 7.1. Basic acute toxicity studies

            1. 7.1.1. Acute oral toxicity

              1. Circumstances in which required

              2. Test guideline

            2. 7.1.2. Acute inhalation toxicity

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            3. 7.1.3. Acute percutaneous toxicity

              1. Circumstances in which required

              2. Test guideline

          2. 7.2. Additional acute toxicity studies

            1. 7.2.1. Skin irritation

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            2. 7.2.2. Eye irritation

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

            3. 7.2.3. Skin sensitisation

              1. Aim of the test

              2. Circumstances in which required

              3. Test guideline

          3. 7.3. Data on exposure

          4. 7.4. Available toxicological data relating to non-active substances

          5. 7.5. Supplementary studies for combinations of plant protection products

            1. Aim of the test

          6. 7.6. Summary and evaluation of health effects

        9. 8. RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED

        10. 9. FATE AND BEHAVIOUR IN THE ENVIRONMENT

        11. 10. EFFECTS ON NON-TARGET ORGANISMS

          1. Introduction

          2. 10.1. Effects on birds

          3. 10.2. Effects on aquatic organisms

          4. 10.3. Effects on bees

          5. 10.4. Effects on arthropods other than bees

          6. 10.5. Effects on earthworms

          7. 10.6. Effects on soil micro-organisms

          8. 10.7. Additional studies

        12. 11. SUMMARY AND EVALUATION OF ENVIRONMENTAL IMPACT

    4. ANNEX IV

      STANDARD PHRASES FOR SPECIAL RISKS FOR HUMANS OR THE ENVIRONMENT AS REFERRED TO IN ARTICLE 16

      1. INTRODUCTION

      2. 1. Standard phrases for special risks

        1. 1.1. Special risks related to humans (RSh)

          1. RSh 1

          2. RSh 2

          3. RSh 3

        2. 1.2. Special risks related to the environment (RSe)

      3. 2. Attribution criteria for standard phrases for special risks

        1. 2.1. Attribution criteria for standard phrases related to humans

          1. RSh 1 Toxic by eye contact.

          2. RSh 2 May cause photosensitisation.

          3. RSh 3 Contact with vapour causes burns to skin and eyes and...

        2. 2.2. Attribution criteria for standard phrases related to the environment

    5. ANNEX V

      STANDARD PHRASES FOR SAFETY PRECAUTIONS FOR THE PROTECTION OF HUMANS OR THE ENVIRONMENT AS REFERRED TO IN ARTICLE 16

      1. INTRODUCTION

      2. 1. General provisions

        1. SP 1

      3. 2. Specific safety precautions

        1. 2.1. Safety precautions for operators (SPo)

          1. General provisions

            1. 1. Member States may identify suitable personal protective equipment for operators...

            2. 2. Member States may further identify the specific tasks which require...

            3. 3. Member States may add specifications of engineering controls, such as:...

          2. Specific provisions

            1. SPo 1

            2. SPo 2

            3. SPo 3

            4. SPo 4

            5. SPo 5

        2. 2.2. Safety precautions related to the environment (SPe)

          1. SPe 1

          2. SPe 2

          3. SPe 3

          4. SPe 4

          5. SPe 5

          6. SPe 6

          7. SPe 7

          8. SPe 8

        3. 2.3. Safety precautions related to good agricultural practice

          1. SPa 1

        4. 2.4. Specific safety precautions for rodenticides (SPr)

          1. SPr 1

          2. SPr 2

          3. SPr 3

      4. 3. Attribution criteria for standard phrases for specific safety precautions

        1. 3.1. INTRODUCTION

        2. 3.2. Attribution criteria for standard phrases for safety precautions for operators...

          1. SPo 1

          2. SPo 2

          3. SPo 3

          4. SPo 4

          5. SPo 5

        3. 3.3. Attribution criteria for standard phrases for safety precautions for the...

          1. SPe 1

          2. SPe 2

          3. SPe 3

          4. SPe 4

          5. SPe 5

          6. SPe 6

          7. SPe 7

          8. SPe 8

        4. 3.4. Attribution criteria for standard phrases for safety precautions for good...

          1. SPa 1

        5. 3.5. Attribution criteria for standard phrases for specific safety precautions for...

          1. SPr 1

          2. SPr 2

          3. SPr 3

    6. ANNEX VI

      1. PART I UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF CHEMICAL PLANT PROTECTION PRODUCTS

        1. CONTENTS

          1. A. INTRODUCTION

          2. B. EVALUATION

            1. 1. General principles

            2. 2. Specific principles

              1. 2.1. Efficacy

              2. 2.2. Absence of unacceptable effects on plants or plant products

              3. 2.3. Impact on vertebrates to be controlled

              4. 2.4. Impact on human or animal health

                1. 2.4.1. arising from the plant protection product

                2. 2.4.2. arising from residues

              5. 2.5. Influence on the environment

                1. 2.5.1. Fate and distribution in the environment

                2. 2.5.2. Impact on non-target species

              6. 2.6. Analytical methods

              7. 2.7. Physical and chemical properties

          3. C. DECISION-MAKING

            1. 1. General principles

            2. 2. Specific principles

              1. 2.1. Efficacy

              2. 2.2. Absence of unacceptable effects on plants or plant products

              3. 2.3. Impact on vertebrates to be controlled

              4. 2.4. Impact on human or animal health

                1. 2.4.1. arising from the plant protection product

                2. 2.4.2. arising from residues

              5. 2.5. Influence on the environment

                1. 2.5.1. Fate and distribution in the environment

                2. 2.5.2. Impact on non-target species

              6. 2.6. Analytical methods

              7. 2.7. Physical and chemical properties

        2. A. INTRODUCTION

          1. 1. The principles developed in this Annex aim to ensure that...

          2. 2. In evaluating applications and granting authorizations Member States shall:

          3. 3. Where in the specific principles on evaluation reference is made...

          4. 4. Where the data and information provided are sufficient to permit...

          5. 5. During the process of evaluation and decision-making, Member States shall...

          6. 6. The judgements made by the competent authorities of the Member...

        3. B. EVALUATION

          1. 1. General principles

            1. 1. Having regard to current scientific and technical knowledge, Member States...

            2. 2. In accordance with the terms of Article 4 of this...

            3. 3. In the evaluation of applications submitted, Member States shall have...

            4. 4. In interpreting the results of evaluations, Member States shall take...

            5. 5. Where specific principles of Section 2 provide for the use...

            6. 6. Where metabolites, degradation or reaction products are referred to in...

          2. 2. Specific priciples

            1. 2.1. Efficacy

              1. 2.1.1. Where the proposed use concerns the control of or protection...

              2. 2.1.2. Where the proposed use concerns an effect other than the...

              3. 2.1.3. Member States shall evaluate the efficacy data on the plant...

              4. 2.1.4. Member States shall evaluate the performance of the plant protection...

              5. 2.1.5. Where the product label includes requirements for use of the...

            2. 2.2. Absence of unacceptable effects on plants or plant products

              1. 2.2.1. Member States shall evaluate the degree of adverse effects on...

              2. 2.2.2. Where the available data indicate that the active substance or...

              3. 2.2.3. Where the product label includes requirements for use of the...

            3. 2.3. Impact on vertebrates to be controlled

            4. 2.4. Impact on human or animal health

              1. 2.4.1. arising from the plant protection product

                1. 2.4.1.1. Member States shall evaluate operator exposure to the active substance...

                2. 2.4.1.2. Member States shall examine information relating to the nature and...

                3. 2.4.1.3. Member States shall examine the nature and characteristics of the...

                4. 2.4.1.4. Member States shall evaluate the possibility of exposure of other...

              2. 2.4.2. Arising from residues

                1. 2.4.2.1. Member States shall evaluate the specific information on toxicology as...

                2. 2.4.2.2. Prior to evaluating the residue levels in the reported trials...

                3. 2.4.2.3. On the basis of suitable statistical models Member States shall...

                4. 2.4.2.4. Member States shall evaluate the residue levels observed in products...

                5. 2.4.2.5. Member States shall estimate the potential exposure of consumers through...

                6. 2.4.2.6. Member States shall, where relevant, estimate the exposure of animals,...

            5. 2.5. Influence on the environment

              1. 2.5.1. Fate and distribution in the environment

                1. 2.5.1.1. Member States shall evaluate the possibility of the plant protection...

                2. 2.5.1.2. Member States shall evaluate the possibility of the plant protection...

                3. 2.5.1.3. Member States shall evaluate the possibility of the plant protection...

                4. 2.5.1.4. Member States shall evaluate the possibility of the plant protection...

                5. 2.5.1.5. Member States shall evaluate the procedures for destruction or decontamination...

              2. 2.5.2. Impact on non-target species

                1. 2.5.2.1. Member States shall evaluate the possibility of exposure of birds...

                2. 2.5.2.2. Member States shall evaluate the possibility of exposure of aquatic...

                3. 2.5.2.3. Member States shall evaluate the possibility of exposure of honeybees...

                4. 2.5.2.4. Member States shall evaluate the possibility of exposure of beneficial...

                5. 2.5.2.5. Member States shall evaluate the possibility of exposure of earthworms...

                6. 2.5.2.6. Member States shall, where the evaluation carried out under Part...

            6. 2.6. Analytical methods

              1. 2.6.1. for formulation analysis:

              2. 2.6.2. for residue analysis:

            7. 2.7. Physical and chemical properties

              1. 2.7.1. Member States shall evaluate the actual active substance content of...

              2. 2.7.2. Member States shall evaluate the physical and chemical properties of...

              3. 2.7.3. Where proposed label claims include requirements or recommendations for use...

        4. C. DECISION-MAKING

          1. 1. General principles

            1. 1. Where appropriate, Member States shall impose conditions or restrictions with...

            2. 2. Member States shall ensure that, where necessary, decisions taken with...

            3. 3. Member States shall ensure that the authorized amounts, in terms...

            4. 4. Member States shall ensure that decisions respect the principles of...

            5. 5. Since the evaluation is to be based on data concerning...

            6. 6. Before issuing an authorization, Member States shall ensure that the...

            7. 7. Before issuing authorizations, Member States shall:

            8. 8. No authorization shall be granted unless all the requirements referred...

            9. 9. Where an authorization has been granted according to the requirements...

          2. 2. Specific principles

            1. 2.1. Efficacy

              1. 2.1.1. Where the proposed uses include recommendations for the control of...

              2. 2.1.2. The level, consistency and duration of control or protection or...

              3. 2.1.3. Where relevant, yield response when the product is used and...

              4. 2.1.4. Conclusions as to the performance of the preparation must be...

              5. 2.1.5. Where proposed label claims include requirements for use of the...

            2. 2.2. Absence of unacceptable effects on plants or plant products

              1. 2.2.1. There must be no relevant phytotoxic effects on treated plants...

              2. 2.2.2. There must be no reduction of yield at harvest due...

              3. 2.2.3. There must be no unacceptable adverse effects on the quality...

              4. 2.2.4. There must be no unacceptable adverse effects on treated plants...

              5. 2.2.5. There must be no unacceptable impact on succeeding crops, except...

              6. 2.2.6. There must be no unacceptable impact on adjacent crops, except...

              7. 2.2.7. Where proposed label claims include requirements for use of the...

              8. 2.2.8. The proposed instructions for cleaning the application equipment must be...

            3. 2.3. Impact on vertebrates to be controlled

            4. 2.4. Impact on human or animal health

              1. 2.4.1. arising from the plant protection product

                1. 2.4.1.1. No authorization shall be granted if the extent of operator...

                2. 2.4.1.2. Where the proposed conditions of use require use of items...

                3. 2.4.1.3. Plant protection products which because of particular properties or if...

                4. 2.4.1.4. Waiting and re-entry safety periods or other precautions must be...

                5. 2.4.1.5. Waiting and re-entry safety periods or other precautions must be...

                6. 2.4.1.6. Waiting and re-entry periods or other precautions to ensure that...

              2. 2.4.2. arising from residues

                1. 2.4.2.1. Authorizations must ensure that residues occurring reflect the minimum quantities...

                2. 2.4.2.2. Where no Community maximum residue limit (MRL) or provisional MRL...

                3. 2.4.2.3. Where the new circumstances under which the plant protection product...

                4. 2.4.2.4. Where a Community MRL exists Member States shall not grant...

                5. 2.4.2.5. In the cases referred to in points 2.4.2.2 and 2.4.2.3,...

                6. 2.4.2.6. Where the nature of residues is affected during processing, a...

                7. 2.4.2.7. Where the treated plants or plant products are intended to...

            5. 2.5. Influence on the environment

              1. 2.5.1. Fate and distribution in the environment

                1. 2.5.1.1. No authorization shall be granted if the active substance and,...

                2. 2.5.1.2. No authorization shall be granted if the concentration of the...

                3. 2.5.1.3. No authorization shall be granted if the concentration of the...

                4. 2.5.1.4. No authorization shall be granted if the airborne concentration of...

              2. 2.5.2. Impact on non-target species

                1. 2.5.2.1. Where there is a possibility of birds and other non-target...

                2. 2.5.2.2. Where there is a possibility of aquatic organisms being exposed,...

                3. 2.5.2.3. Where there is a possibility of honeybees being exposed, no...

                4. 2.5.2.4. Where there is a possibility of beneficial arthropods other than...

                5. 2.5.2.5. Where there is a possibility of earthworms being exposed, no...

                6. 2.5.2.6. Where there is a possibility of non-target soil micro-organisms being...

            6. 2.6. Analytical methods

              1. 2.6.1. for formulation analysis:

              2. 2.6.2. for residue analysis:

            7. 2.7. Physical and chemical properties

              1. 2.7.1. Where an appropriate FAO specification exists, that specification must be...

              2. 2.7.2. Where no appropriate FAO specification exists, the physical and chemical...

              3. 2.7.3. Where the proposed label claims include requirements or recommendations for...

      2. PART II UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTAINING MICRO-ORGANISMS

        2. A. INTRODUCTION

          1. 1. The principles developed in Part II of this Annex aim to...

          2. 2. In evaluating applications for granting authorisations Member States shall:

          3. 3. Where, in the specific principles on evaluation, reference is made...

          4. 4. Where the data and information provided are sufficient to permit...

          5. 5. During the process of evaluation and decision-making, the Member State...

          6. 6. The judgements made by the competent authorities of the Member...

          7. 7. A microbial plant protection product may contain viable and non-viable...

          8. 8. Member States must take into account those guidance documents taken...

          9. 9. For genetically modified micro-organisms, Directive 2001/18/EC of the European Parliament...

          10. 10. Definitions and explanations of microbiological terms

        3. B. EVALUATION

          1. 1. General principles

            1. 1.1. Having regard to current scientific and technical knowledge, Member States...

            2. 1.2. The quality/methodology of tests, where there are no standardised test...

            3. 1.3. In interpreting the results of evaluations, Member States shall take...

            4. 1.4. Member States shall evaluate each microbial plant protection product for...

            5. 1.5. In evaluating applications and granting authorisations Member States shall consider...

            6. 1.6. In the evaluation, Member States shall consider the agricultural, plant...

            7. 1.7. Where specific principles in Section 2 provide for the use of...

            8. 1.8. The data requirements, specified in Annex IIB and IIIB, contain guidance...

          2. 2. Specific principles

            1. 2.1. Identity

              1. 2.1.1. Identity of the micro-organism in the plant protection product

              2. 2.1.2. Identity of the plant protection product

            2. 2.2. Biological, physical, chemical, and technical properties

              1. 2.2.1. Biological properties of the micro-organism in the plant protection product...

                1. 2.2.1.1. The origin of the strain, where relevant, its natural habitat...

                2. 2.2.1.2. The ability of micro-organisms to adapt to the environment must...

                3. 2.2.1.3. The mode of action of the micro-organism should be evaluated...

                4. 2.2.1.4. In order to evaluate possible effects on non-target organisms, information...

                5. 2.2.1.5. Many micro-organisms produce antibiosis substances that cause normal interferences in...

              2. 2.2.2. Physical, chemical and technical properties of the plant protection product...

                1. 2.2.2.1. Depending on the nature of the micro-organism and the formulation...

                2. 2.2.2.2. Shelf-life and storage stability of the preparation must be evaluated,...

                3. 2.2.2.3. Member States shall evaluate the physical and chemical properties of...

                4. 2.2.2.4. Where the proposed label claims include requirements or recommendations for...

            3. 2.3. Further information

              1. 2.3.1. Quality control of the production of the micro-organism in the...

              2. 2.3.2. Quality control of the plant protection product

            4. 2.4. Efficacy

              1. 2.4.1. Where the proposed use concerns the control of or protection...

              2. 2.4.2. Member States shall evaluate whether significant damage, loss or inconvenience...

              3. 2.4.3. Member States shall evaluate the efficacy data provided for in...

              4. 2.4.4. Member States shall evaluate the performance of the plant protection...

              5. 2.4.5. Member States shall evaluate the degree of adverse effects on...

              6. 2.4.6. Where the plant protection product label includes requirements for use...

              7. 2.4.7. Where the available data indicate that the micro-organism or significant...

              8. 2.4.8. Where the proposed use of a plant protection product is...

            5. 2.5. Identification/detection and quantification methods

              1. 2.5.1. Analytical methods for the plant protection product

                1. 2.5.1.1. Non-viable components

                2. 2.5.1.2. Viable components

              2. 2.5.2. Analytical methods for the determination of residues

                1. 2.5.2.1. Non-viable residues

                2. 2.5.2.2. Viable residues

            6. 2.6. Impact on human or animal health

              1. 2.6.1. Effects on human or animal health arising from the plant...

                1. 2.6.1.1. Member States shall evaluate operator exposure to the micro-organism, and/or...

                2. 2.6.1.2. Member States shall examine information relating to the nature and...

                3. 2.6.1.3. Member States shall examine the nature and characteristics of the...

                4. 2.6.1.4. Member States shall evaluate the possibility of exposure of other...

              2. 2.6.2. Effects on human or animal health arising from residues

                1. 2.6.2.1. Non-viable residues

                2. 2.6.2.2. Viable residues

            7. 2.7. Fate and behaviour in the environment

              1. 2.7.1. Member States shall evaluate the possibility of contamination of ground...

              2. 2.7.2. Member States shall evaluate the risk for the aquatic compartment...

              3. 2.7.3. Member States shall evaluate the possibility of exposure of organisms...

              4. 2.7.4. Member States shall evaluate the possibility of exposure of organisms...

            8. 2.8. Effects on and exposure of non-target organisms

              1. 2.8.1. Member States shall evaluate the possibility of exposure of and...

                1. 2.8.1.1. A micro-organism may give rise to risks because of its...

                2. 2.8.1.2. A plant protection product may give rise to toxic effects...

              2. 2.8.2. Member States shall evaluate the possibility of exposure of and...

                1. 2.8.2.1. A micro-organism may give rise to risks because of its...

                2. 2.8.2.2. A plant protection product may give rise to toxic effects...

              3. 2.8.3. Member States shall evaluate the possibility of exposure of and...

                1. 2.8.3.1. A micro-organism may give rise to risks because of its...

                2. 2.8.3.2. A plant protection product may give rise to toxic effects...

              4. 2.8.4. Member States shall evaluate the possibility of exposure of and...

                1. 2.8.4.1. A micro-organism may give rise to risks because of its...

                2. 2.8.4.2. A plant protection product may give rise to toxic effects...

              5. 2.8.5. Member States shall evaluate the possibility of exposure of and...

                1. 2.8.5.1. A micro-organism may give rise to risks because of its...

                2. 2.8.5.2. A plant protection product may give rise to toxic effects...

              6. 2.8.6. Member States shall evaluate the possibility of exposure of and...

                1. 2.8.6.1. A micro-organism may give rise to risks because of its...

                2. 2.8.6.2. Member States shall evaluate the impact of exotic/non-indigenous micro-organisms on...

                3. 2.8.6.3. A plant protection product may give rise to toxic effects...

            9. 2.9. Conclusions and proposals

        4. C. DECISION-MAKING

          1. 1. General principles

            1. 1.1. Where appropriate, Member States shall impose conditions or restrictions on...

            2. 1.2. Member States shall ensure that decisions taken to grant authorisations,...

            3. 1.3. Member States shall ensure that the authorised amounts, in terms...

            4. 1.4. Member States shall ensure that decisions respect the principles of...

            5. 1.5. Since the evaluation is to be based on data concerning...

            6. 1.6. Before issuing an authorisation, Member States shall ensure that the...

            7. 1.7. Before issuing authorisations, Member States shall:

            8. 1.8. No authorisation shall be granted unless all the requirements referred...

            9. 1.9. Where an authorisation has been granted according to the requirements...

            10. 1.10. Member States shall ensure, as far as is practically possible,...

            11. 1.11. Where the micro-organism has been genetically modified, as defined in...

            12. 1.12. In accordance with Article 1(3) of this Directive, no authorisation shall...

            13. 1.13. No authorisation shall be granted if relevant metabolites/toxins (i.e. those...

            14. 1.14. Member States shall ensure that adequate quality control measures are...

          2. 2. Specific principles

            1. 2.1. Identity

            2. 2.2. Biological and technical properties

              1. 2.2.1. There must be sufficient information to permit assessment of the...

              2. 2.2.2. No authorisation shall be granted if, at any stage in...

            3. 2.3. Further information

            4. 2.4. Efficacy

              1. 2.4.1. Performance

                1. 2.4.1.1. No authorisation shall be granted where the proposed uses include...

                2. 2.4.1.2. The level, consistency and duration of control or protection or...

                3. 2.4.1.3. Where relevant, yield response when the plant protection product is...

                4. 2.4.1.4. Conclusions as to the performance of the preparation must be...

                5. 2.4.1.5. Where proposed label claims include requirements for use of the...

                6. 2.4.1.6. If there is evidence of a development of resistance of...

                7. 2.4.1.7. Only plant protection products containing non-viable micro-organisms may be authorised...

              2. 2.4.2. Absence of unacceptable effects on plants and plant products

                1. 2.4.2.1. There must be no relevant phytotoxic effects on treated plants...

                2. 2.4.2.2. There must be no reduction of yield at harvest due...

                3. 2.4.2.3. There must be no unacceptable adverse effects on the quality...

                4. 2.4.2.4. There must be no unacceptable adverse effects on treated plants...

                5. 2.4.2.5. There must be no unacceptable impact on succeeding crops, except...

                6. 2.4.2.6. There must be no unacceptable impact on adjacent crops, except...

                7. 2.4.2.7. Where proposed label claims include requirements for use of the...

                8. 2.4.2.8. The proposed instructions for cleaning the application equipment must be...

            5. 2.5. Identification/detection and quantification methods

              1. 2.5.1. No authorisation shall be granted unless there is an adequate...

              2. 2.5.2. No authorisation shall be granted unless there are adequate methods...

            6. 2.6. Impact on human and animal health

              1. 2.6.1. Effects on human and animal health arising from the plant...

                1. 2.6.1.1. No authorisation shall be granted if on the basis of...

                2. 2.6.1.2. No authorisation shall be granted if the micro-organism and/or the...

                3. 2.6.1.3. All micro-organisms should be regarded as potential sensitisers, unless it...

                4. 2.6.1.4. No authorisation shall be granted if it is known that...

                5. 2.6.1.5. Plant protection products which, because of particular properties, or which,...

                6. 2.6.1.6. Waiting and re-entry safety periods or other precautions must be...

                7. 2.6.1.7. Waiting and re-entry safety periods or other precautions must be...

                8. 2.6.1.8. Waiting and re-entry periods or other precautions to ensure that...

                9. 2.6.1.9. The conditions of authorisation shall be in compliance with Council...

              2. 2.6.2. Effects on human and animal health arising from residues

                1. 2.6.2.1. No authorisation shall be granted unless there is sufficient information...

                2. 2.6.2.2. No authorisation shall be granted unless viable residues and/or non-viable...

            7. 2.7. Fate and behaviour in the environment

              1. 2.7.1. No authorisation shall be granted if the available information indicates...

              2. 2.7.2. No authorisation shall be granted if contamination of ground water,...

              3. 2.7.3. No authorisation shall be granted if the contamination of groundwater...

              4. 2.7.4. No authorisation shall be granted if the contamination of surface...

              5. 2.7.5. No authorisation shall be granted if it is known that...

              6. 2.7.6. No authorisation shall be granted unless there is sufficient information...

              7. 2.7.7. No authorisation shall be granted if it can be expected...

            8. 2.8. Effects on non-target organisms

              1. 2.8.1. Where there is a possibility of birds and other non-target...

              2. 2.8.2. Where there is a possibility of aquatic organisms being exposed,...

              3. 2.8.3. Where there is a possibility of bees being exposed, no...

              4. 2.8.4. Where there is a possibility of arthropods other than bees...

              5. 2.8.5. Where there is a possibility of earthworms being exposed, no...

              6. 2.8.6. Where there is a possibility of non-target soil micro-organisms being...

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