Commission Regulation (EU) No 545/2011 (repealed)Show full title

1. Introductory Text

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

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

4. Signature

5. 1. ANNEX

      DATA REQUIREMENTS FOR PLANT PROTECTION PRODUCTS, AS PROVIDED FOR IN ARTICLE 8(1)(c) OF REGULATION (EC) No 1107/2009

      1. INTRODUCTION

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

         2. 2. Tests and analyses

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

            2. 2.2. Tests and analyses, required under points 6.2 to 6.7 of...

            3. 2.3. Officially recognised testing facilities and organisations, and, where requested, official...

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

            5. 2.5. . . . . . . . . . ....

            6. 2.6. . . . . . . . . . ....

         3. 3. . . . . . . . . . ....

         4. 4. . . . . . . . . . ....

      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. . . . . . . . . . ....

               2. 1.4.2. . . . . . . . . . ....

               3. 1.4.3. . . . . . . . . . ....

               4. 1.4.4. . . . . . . . . . ....

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

               1. 1.5.1. . . . . . . . . . ....

            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 oxidising properties

               1. 2.2.1. . . . . . . . . . ....

               2. 2.2.2. . . . . . . . . . ....

            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. . . . . . . . . . ....

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

            5. 2.5. Viscosity and surface tension

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

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

               3. 2.5.3. . . . . . . . . . ....

            6. 2.6. Relative density and bulk density

               1. 2.6.1. . . . . . . . . . ....

               2. 2.6.2. . . . . . . . . . ....

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

               1. 2.7.1. . . . . . . . . . ....

               2. 2.7.2. . . . . . . . . . ....

               3. 2.7.3. . . . . . . . . . ....

            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. . . . . . . . . . ....

                  2. 2.8.6.2. . . . . . . . . . ....

                  3. 2.8.6.3. . . . . . . . . . ....

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

                  1. 2.8.7.1. . . . . . . . . . ....

                  2. 2.8.7.2. . . . . . . . . . ....

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

                  1. 2.8.8.1. . . . . . . . . . ....

                  2. 2.8.8.2. . . . . . . . . . ....

                  3. 2.8.8.3. . . . . . . . . . ....

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

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

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

            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. . . . . . . . . . ....

               2. 4.1.2. . . . . . . . . . ....

               3. 4.1.3. . . . . . . . . . ....

            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. . . . . . . . . . ....

               2. 4.3.2. . . . . . . . . . ....

            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 neutralisation

               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. . . . . . . . . . ....

               2. 5.1.2. . . . . . . . . . ....

               3. 5.1.3. Specificity, linearity, accuracy and repeatability

                  1. 5.1.3.1. . . . . . . . . . ....

                  2. 5.1.3.2. . . . . . . . . . ....

                  3. 5.1.3.3. . . . . . . . . . ....

                  4. 5.1.3.4. . . . . . . . . . ....

            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 products

                  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 and...

               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 method

               2. 7.1.2. Percutaneous

                  1. Circumstances in which required

                  2. Test method

               3. 7.1.3. Inhalation

                  1. Aim of the test

                  2. Circumstances in which required

                  3. Test method

               4. 7.1.4. Skin irritation

                  1. Aim of the test

                  2. Circumstances in which required

                  3. Test method

               5. 7.1.5. Eye irritation

                  1. Aim of the test

                  2. Circumstances in which required

                  3. Test method

               6. 7.1.6. Skin sensitisation

                  1. Aim of the test

                  2. Circumstances in which required

                  3. Test method

               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

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

               2. (ii) In particular, the information provided for the plant protection product,...

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

               4. (iv) Where relevant tests shall be designed and data analysed using...

               5. (v) Predicted environmental concentrations in soil (PECS), water (PECSW and PECGW)...

            2. 9.1. Fate and behaviour in soil

               1. 9.1.1. Rate of degradation in soil

                  1. 9.1.1.1. Laboratory studies

                     1. Aim of the test

                     2. Circumstances in which required

                     3. Test conditions

                     4. Test guideline

                  2. 9.1.1.2. Field studies

                     1. — Soil dissipation studies

                        1. Aim of the test

                        2. Circumstances in which required

                        3. Test conditions and 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

                        4. Test guideline

               2. 9.1.2. Mobility in the soil

                  1. Aim of the test

                  2. 9.1.2.1. Laboratory studies

                     1. Circumstances in which required

                     2. Test guideline

                  3. 9.1.2.2. Lysimeter studies or field leaching studies

                     1. Aim of the tests

                     2. Circumstances in which required

                     3. Test conditions

               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

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

                2. (ii) In particular, the information provided for the plant protection product,...

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

                4. (iv) In general, much of the data relating to impact on...

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

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

                7. (vii) Where exposure data are necessary to decide whether a study...

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

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

             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 mesocosm 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 Sections 9 and 10

         12. 12. Further information

             1. 12.1. Information on authorisations in other countries

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

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

             4. 12.4. . . . . . . . . . ....

             5. 12.5. Specimens of proposed packaging

      3. PART B PREPARATIONS OF MICRO-ORGANISMS INCLUDING VIRUSES

         1. Introduction

            1. (i) This Part provides data requirements for the authorisation of a...

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

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

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

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

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

         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...

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

               2. (ii) For preparations the following information must be reported:

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

               4. (iv) For co-formulants the function must be given:

               5. (v) Identification of contaminating micro-organisms and other components derived from production...

            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...

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

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

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

               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...

                  1. (i) The size distribution of particles in the case of powders,...

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

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

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

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

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

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

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

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

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

            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...

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

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

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

            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

            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 products

                  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 and...

               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...

         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 method

               2. 7.1.2. Acute inhalation toxicity

                  1. Aim of the test

                  2. Circumstances in which required

                  3. Test method

               3. 7.1.3. Acute percutaneous toxicity

                  1. Circumstances in which required

                  2. Test method

            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 method

               2. 7.2.2. Eye irritation

                  1. Aim of the test

                  2. Circumstances in which required

                  3. Test method

               3. 7.2.3. Skin sensitisation

                  1. Aim of the test

                  2. Circumstances in which required

                  3. Test method

            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

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

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

                3. (iii) In particular, the information provided for the plant protection product,...

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

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

                6. (vi) Where exposure data are necessary to decide whether a study...

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

             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