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Commission Regulation (EU) No 544/2011 (repealed)Show full title

Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)

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  1. Introductory Text

  2. Article 1.. . . . . . . . . ....

  3. Article 2.. . . . . . . . . ....

  4. Signature

    1. ANNEX

      DATA REQUIREMENTS FOR ACTIVE SUBSTANCES, AS PROVIDED FOR IN ARTICLE 8(1)(b) OF REGULATION (EC) No 1107/2009

      1. INTRODUCTION

        1. 1. . . . . . . . . . ....

        2. 2. Test and analyses

          1. 2.1. . . . . . . . . . ....

          2. 2.2. By way of derogation from point 2.1, Member States may...

          3. 2.3. By way of derogation from point 2.1, Member States may...

          4. 2.4. . . . . . . . . . ....

      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, EC 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. stabilisers), together with...

          11. 1.11. Analytical profile of batches

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

          1. (i) The information provided, must describe the physical and chemical properties...

          2. (ii) . . . . . . . . . ....

          3. (iii) . . . . . . . . . ....

          4. (iv) In certain specified instances, tests must be conducted using purified...

          5. 2.1. Melting point and boiling point

            1. 2.1.1. . . . . . . . . . ....

            2. 2.1.2. . . . . . . . . . ....

            3. 2.1.3. . . . . . . . . . ....

          6. 2.2. Relative density

          7. 2.3. Vapour pressure (in Pa), volatility (e.g. Henry’s law constant)

            1. 2.3.1. . . . . . . . . . ....

            2. 2.3.2. . . . . . . . . . ....

          8. 2.4. Appearance (physical state, colour and odour; if known)

            1. 2.4.1. . . . . . . . . . ....

            2. 2.4.2. . . . . . . . . . ....

          9. 2.5. Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths...

            1. 2.5.1. . . . . . . . . . ....

            2. 2.5.2. . . . . . . . . . ....

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

          11. 2.7. Solubility in organic solvents

          12. 2.8. Partition coefficient n-octanol/water including effect of pH (4 to 10)...

          13. 2.9. Stability in water, hydrolysis rate, photochemical degradation, quantum yield and...

            1. 2.9.1. . . . . . . . . . ....

            2. 2.9.2. . . . . . . . . . ....

            3. 2.9.3. . . . . . . . . . ....

            4. 2.9.4. . . . . . . . . . ....

          14. 2.10. Stability in air, photochemical degradation, identity of breakdown product(s)

          15. 2.11. Flammability including auto-flammability

            1. 2.11.1. . . . . . . . . . ....

            2. 2.11.2. . . . . . . . . . ....

          16. 2.12. Flash point

          17. 2.13. Explosive properties

          18. 2.14. Surface tension

          19. 2.15. Oxidising properties

        3. 3. Further information on the active substance

          1. (i) . . . . . . . . . ....

          2. (ii) . . . . . . . . . ....

          3. (iii) . . . . . . . . . ....

          4. (iv) . . . . . . . . . ....

          5. (v) . . . . . . . . . ....

          6. 3.1. Function, e.g. fungicide, herbicide, insecticide, repellent, growth regulator

          7. 3.2. Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach...

            1. 3.2.1. . . . . . . . . . ....

            2. 3.2.2. . . . . . . . . . ....

          8. 3.3. Field of use envisaged, e.g. field, protected crops, storage of...

          9. 3.4. Harmful organisms controlled and crops or products protected or treated...

            1. 3.4.1. . . . . . . . . . ....

            2. 3.4.2. . . . . . . . . . ....

            3. 3.4.3. . . . . . . . . . ....

          10. 3.5. Mode of action

            1. 3.5.1. . . . . . . . . . ....

            2. 3.5.2. . . . . . . . . . ....

            3. 3.5.3. . . . . . . . . . ....

          11. 3.6. Information on the occurrence or possible occurrence of the development...

          12. 3.7. Recommended methods and precautions concerning handling, storage, transport or fire...

          13. 3.8. Procedures for destruction or decontamination

            1. 3.8.1. Controlled incineration

            2. 3.8.2. Others

          14. 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. (i) Specificity

            2. (ii) Linearity

            3. (iii) Accuracy

            4. (iv) Precision

            5. 4.1.1. . . . . . . . . . ....

            6. 4.1.2. . . . . . . . . . ....

            7. 4.1.3. Specificity, linearity, accuracy and repeatability

              1. 4.1.3.1. . . . . . . . . . ....

              2. 4.1.3.2. . . . . . . . . . ....

              3. 4.1.3.3. . . . . . . . . . ....

              4. 4.1.3.4. . . . . . . . . . ....

          3. 4.2. Methods for the determination of residues

            1. (i) Specificity

            2. (ii) Precision

            3. (iii) Recovery

            4. (iv) Limit of determination

            5. 4.2.1. Residues in and/or on plants, plant products, foodstuffs (of plant...

            6. 4.2.2. Residues in soil

            7. 4.2.3. Residues in water (including drinking water, ground water and surface...

            8. 4.2.4. Residues in air

            9. 4.2.5. Residues in body fluids and tissues

        5. 5. Toxicological and metabolism studies

          1. Introduction

            1. (i) The information provided, taken together with that provided for one...

            2. (ii) . . . . . . . . . ....

            3. (iii) . . . . . . . . . ....

            4. (iv) . . . . . . . . . ....

            5. (v) . . . . . . . . . ....

            6. (vi) . . . . . . . . . ....

            7. (vii) . . . . . . . . . ....

            8. (viii) . . . . . . . . . ....

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

            1. Circumstances in which required

            2. Test guideline

          3. 5.2. Acute toxicity

            1. 5.2.1. Oral

              1. Circumstances 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 sensitisation

              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

            1. (i) The information provided, taken together with that provided for one...

            2. (ii) . . . . . . . . . ....

            3. (iii) . . . . . . . . . ....

            4. (iv) . . . . . . . . . ....

            5. (v) Stability of residues during storage.

          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 definition

          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

            1. (i) . . . . . . . . . ....

            2. (ii) In particular, the information provided for the active substance, together...

            3. (iii) A detailed description (specification) of the material used, as provided...

            4. (iv) . . . . . . . . . ....

            5. (v) . . . . . . . . . ....

            6. (vi) Where relevant, tests shall be designed and data analysed using...

          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. Aim of the tests

                2. 7.1.1.1.1. Aerobic degradation

                  1. Circumstances in which required

                  2. Test conditions

                  3. Test guideline

                3. 7.1.1.1.2. Supplementary studies

                  1. — Anaerobic degradation

                    1. Circumstances in which required

                    2. Test conditions and test guideline

                  2. — Soil photolysis

                    1. Circumstances in which required

                    2. Test guideline

              2. 7.1.1.2. Rate of degradation

                1. 7.1.1.2.1. Laboratory studies

                  1. Aim of the tests

                    1. — Aerobic degradation

                      1. Circumstances in which required

                      2. Test conditions

                      3. Test guideline

                    2. — Anaerobic degradation

                      1. Circumstances in which required

                      2. Test conditions

                      3. Test guideline

                2. 7.1.1.2.2. Field studies

                  1. — Soil dissipation studies

                    1. Aim of the test

                    2. Circumstances in which required

                    3. Test conditions

                    4. Test guideline

                  2. — Soil residue studies

                    1. Aim of the test

                    2. Circumstances in which required

                    3. Test conditions

                    4. Test guideline

                  3. — Soil accumulation studies

                    1. Aim of the tests

                    2. Circumstances in which required

                    3. Test conditions

            2. 7.1.2. Adsorption and desorption

              1. Aim of the test

              2. Circumstances in which required

              3. Test conditions

              4. Test guideline

            3. 7.1.3. Mobility in the soil

              1. 7.1.3.1. Column leaching studies

                1. Aim of the test

                2. Circumstances in which required

                3. Test guideline

              2. 7.1.3.2. Aged residue column leaching

                1. Aim of the test

                2. Circumstances in which required

                3. Test conditions

                4. Test guideline

              3. 7.1.3.3. Lysimeter studies or field leaching studies

                1. Aim of the tests

                2. Circumstances in which required

                3. Test conditions

                  1. — Lysimeter studies

                    1. Test conditions

                  2. — Field leaching studies

                    1. Test conditions

                    2. Test guideline

          3. 7.2. Fate and behaviour in water and air

            1. Aim of the tests

            2. 7.2.1. Route and rate of degradation in aquatic systems (as far...

              1. Aim of the tests

              2. 7.2.1.1. Hydrolytic degradation

                1. Circumstances in which required

                2. Test conditions and test guideline

              3. 7.2.1.2. Photochemical degradation

                1. Circumstances in which required

                2. Test conditions and test guideline

              4. 7.2.1.3. Biological degradation

                1. 7.2.1.3.1. ‘Ready biodegradability’

                  1. Circumstances in which required

                  2. Test guideline

                2. 7.2.1.3.2. Water/sediment study

                  1. Circumstances in which required

                  2. Test guideline

              5. 7.2.1.4. Degradation in the saturated zone

                1. Circumstances in which required

                2. Test conditions

            3. 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

            1. (i) . . . . . . . . . ....

            2. (ii) In particular, the information provided for the active substance, together...

            3. (iii) . . . . . . . . . ....

            4. (iv) . . . . . . . . . ....

            5. (v) . . . . . . . . . ....

          2. Test substance

            1. (vi) . . . . . . . . . ....

            2. (vii) . . . . . . . . . ....

            3. (viii) In the case of studies in which dosing extends over...

            4. (ix) . . . . . . . . . ....

            5. (x) . . . . . . . . . ....

          3. Test organisms

            1. (xi) . . . . . . . . . ....

          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 arthropods

              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 Sections 7 and 8

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

        11. 11. A dossier as referred to in Part A of the...

      3. PART B MICRO-ORGANISMS INCLUDING VIRUSES

        1. Introduction

          1. (i) Active substances are defined in Article 2(2) of Regulation (EC)...

          2. (ii) For all micro-organisms that are subject to application all available...

          3. (iii) . . . . . . . . . ....

          4. (iv) Where testing is done, a detailed description (specification) of the...

          5. (v) . . . . . . . . . ....

          6. (vi) . . . . . . . . . ....

          7. (vii) In the case of studies in which dosing extends over...

          8. (viii) . . . . . . . . . ....

        2. 1. Identity of the micro-organism

          1. 1.1. Applicant

          2. 1.2. Producer

          3. 1.3. Name and species description, strain characterisation

            1. (i) . . . . . . . . . ....

            2. (ii) Each micro-organism that is subject to the application shall be...

            3. (iii) . . . . . . . . . ....

            4. (iv) . . . . . . . . . ....

            5. (v) . . . . . . . . . ....

          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

            1. (i) . . . . . . . . . ....

            2. (ii) . . . . . . . . . ....

            3. (iii) . . . . . . . . . ....

            4. (iv) . . . . . . . . . ....

          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

            1. (i) . . . . . . . . . ....

            2. (ii) The information provided, taken together with that provided for one...

            3. (iii) . . . . . . . . . ....

            4. (iv) . . . . . . . . . ....

            5. (v) Evaluation of the micro-organism shall be carried out in a...

          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. 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. 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

            1. (i) . . . . . . . . . ....

            2. (ii) In addition, the information provided must be sufficient to:

            3. (iii) . . . . . . . . . ....

          2. 6.1. Persistence 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

            1. (i) Information on the origin, the properties, and the survival of...

            2. (ii) . . . . . . . . . ....

            3. (iii) In particular, the information provided shall be sufficient to:

            4. (iv) Any relevant metabolites (i.e. of concern for human health and/or...

            5. (v) . . . . . . . . . ....

            6. (vi) . . . . . . . . . ....

          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

            1. (i) The information on identity, biological properties and further information in...

            2. (ii) . . . . . . . . . ....

            3. (iii) . . . . . . . . . ....

            4. (iv) In particular, the information provided for the micro-organism, together with...

            5. (v) . . . . . . . . . ....

            6. (vi) . . . . . . . . . ....

            7. (vii) . . . . . . . . . ....

            8. (viii) . . . . . . . . . ....

            9. (ix) . . . . . . . . . ....

          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

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