Commission Regulation (EU) No 544/2011 (repealed)Show full title

1. Introductory Text

2. Article A1. Scope and interpretation

3. Article 1. The data requirements for the approval of an active substance...

4. Article 2. This Regulation shall enter into force on the 20th day...

5. Signature

6. 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. The information required shall:

         2. 2. Test and analyses

            1. 2.1. Tests and analyses must be conducted in accordance with the...

            2. 2.2. By way of derogation from point 2.1, the competent authority...

            3. 2.3. By way of derogation from point 2.1, the competent authority...

            4. 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. 1.4.1 In point 1.4, “ the GB mandatory classification and labelling...

            6. 1.5. Manufacturer’s development code number(s)

            7. 1.6. CAS, EC and CIPAC numbers (if available)

            8. 1.7. Molecular and structural formula, molecular mass

            9. 1.8. Method of manufacture (synthesis pathway) of the active substance

            10. 1.9. Specification of purity of the active substance in g/kg

            11. 1.10. Identity of isomers, impurities and additives (e.g. stabilisers), together with...

            12. 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) The information provided, taken together with that provided for relevant...

            3. (iii) The extent to which active substances of which approval is...

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

            5. 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...

            6. 2.2. Relative density

            7. 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...

            8. 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...

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

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

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

            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. 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)...

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

            15. 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-flammability of active substances as manufactured must be determined...

            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) The information provided must describe the intended purposes for which...

            2. (ii) The information provided must specify the normal methods and precautions...

            3. (iii) The studies, data and information submitted, together with other relevant...

            4. (iv) The studies, data and information submitted, together with other relevant...

            5. (v) The information and data referred to are required for all...

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

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

            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. 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,...

            10. 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...

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

               6. 4.1.2. Methods must also be provided for the determination of significant...

               7. 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. (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) There is a need to investigate and report all potentially...

               3. (iii) In the context of the influence that impurities can have...

               4. (iv) Where studies are conducted using an active substance produced in...

               5. (v) In the case of studies in which dosing extends over...

               6. (vi) For all studies actual achieved dose in mg/kg body weight,...

               7. (vii) Where, as a result of metabolism or other processes in...

               8. (viii) The way of administration of the test substance depends on...

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

               3. (iii) Studies shall be performed in accordance with guidance issued under...

               4. (iv) Where relevant, data shall be analysed using appropriate statistical methods....

               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) The information provided, taken together with that for one or...

               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) Where radio-labelled test material is used, radio-labels shall be positioned...

               5. (v) It may be necessary to conduct separate studies for metabolites,...

               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) The information provided, taken together with that for one or...

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

               3. (iii) There is a need to report all potentially adverse effects...

               4. (iv) The information on fate and behaviour in the environment, generated...

               5. (v) Where relevant, tests shall be designed and data analysed using...

            2. Test substance

               1. (vi) A detailed description (specification) of the material used, as provided...

               2. (vii) Where studies are conducted using active substance produced in the...

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

               4. (ix) For all feeding studies, average achieved dose must be reported,...

               5. (x) It may be necessary to conduct separate studies for metabolites,...

            3. Test organisms

               1. (xi) In order to facilitate the assessment of the significance of...

            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) Pending the acceptance of specific guidelines at international level, the...

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

            5. (v) Where the micro-organism has been genetically modified, a copy of...

            6. (vi) Where relevant, data shall be analysed using appropriate statistical methods....

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

            8. (viii) If the plant protection action is known to be due...

         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) The micro-organism should be deposited at an internationally recognised culture...

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

               3. (iii) Best available technology should be used to identify and characterise...

               4. (iv) Common name or alternative and superseded names and code names...

               5. (v) Relationships to known pathogens shall be indicated.

            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) The information provided must describe the intended purposes for which...

               2. (ii) The information provided must specify the normal methods and precautions...

               3. (iii) The studies, data and information submitted, must demonstrate the suitability...

               4. (iv) The information and data referred to are required for each...

            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) Available information based on the properties of the micro-organism and...

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

               3. (iii) All effects found during investigations shall be reported. Investigations which...

               4. (iv) For all studies actual achieved dose in colony forming units...

               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) The information provided, taken together with that for one or...

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

               3. (iii) For the evaluation of risk arising from residues, experimental data...

            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) The information provided, taken together with other relevant information, and...

               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) Available information on the relationship with naturally occurring wild type...

               6. (vi) Before performing studies as referred to below, the applicant shall...

            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) The choice of the appropriate non-target organisms for testing of...

               3. (iii) The information provided, taken together with that for one or...

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

               5. (v) There is a need to report all potentially adverse effects...

               6. (vi) For all studies, average achieved dose in cfu/kg body weight...

               7. (vii) It may be necessary to conduct separate studies for relevant...

               8. (viii) In order to facilitate the assessment of the significance of...

               9. (ix) Tests must be performed unless it can be justified that...

            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