Commission Regulation (EU) No 284/2013Show full title

1. Introductory Text

2. Article 1. Data requirements for plant protection products

3. Article 2. Repeal

4. Article 3. Transitional measures as regards procedures concerning active substances

5. Article 4. Transitional measures as regards procedures concerning plant protection products

6. Article 5. Entry into force and date of application

7. Signature

8. 1. ANNEX

      1. INTRODUCTION Information to be submitted, its generation and its presentation

         1. 1. The information submitted shall meet the following requirements.

            1. 1.1. The information shall be sufficient to evaluate efficacy and the...

            2. 1.2. Any information on potentially harmful effects of the plant protection...

            3. 1.3. Any information on potentially unacceptable effects of the plant protection...

            4. 1.4. The information shall include all relevant data from the scientific...

            5. 1.5. The information shall include a full and unbiased report of...

            6. 1.6. Where relevant, the information shall be generated using test methods,...

            7. 1.7. The information shall include a full description of the test...

            8. 1.8. Where relevant, the information shall be generated in accordance with...

            9. 1.9. The information shall include a list of endpoints for the...

            10. 1.10. The information shall include the proposed classification and labelling of...

            11. 1.11. Information as provided for in Commission Regulation (EU) No 283/2013...

            12. 1.12. The information provided for the plant protection product and that...

            13. 1.13. Where relevant, tests shall be designed and data analysed using...

            14. 1.14. Exposure calculations shall refer to scientific methods accepted by the...

         2. 2. The requirements set out in this Regulation shall represent the...

         3. 3. Good laboratory practice (GLP)

            1. 3.1. Tests and analyses shall be conducted in accordance with the...

            2. 3.2. By way of derogation from point 3.1, tests and analyses,...

            3. 3.3. Officially recognised testing facilities and organisations, and, where requested by...

            4. 3.4. By way of derogation from point 3.1:

         4. 4. Test material

            1. 4.1. Due to the influence that impurities and other components can...

            2. 4.2. Where radio-labelled test material is used, radio-labels shall be positioned...

         5. 5. Tests on vertebrate animals

            1. 5.1. Tests on vertebrate animals shall be undertaken only where no...

            2. 5.2. The principles of replacement, reduction and refinement of the use...

            3. 5.3. Tests involving the deliberate administration of the active substance or...

            4. 5.4 For ethical reasons, study designs shall be carefully considered, taking...

         6. 6. For purposes of information and of harmonisation the list of...

      2. PART A CHEMICAL PLANT PROTECTION PRODUCTS

         1. SECTION 1 Identity of the plant protection product

            1. 1.1. Applicant

            2. 1.2. Producer of the plant protection product and of the active...

            3. 1.3. Trade name or proposed trade name and producer’s development code...

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

               1. 1.4.1. Composition of the plant protection product

               2. 1.4.2. Information on the active substances

               3. 1.4.3. Information on safeners, synergists and co-formulants

            5. 1.5. Type and code of the plant protection product

            6. 1.6. Function

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

            1. 2.1. Appearance

            2. 2.2. Explosive and oxidising properties

            3. 2.3. Flammability and self-heating

            4. 2.4. Acidity/alkalinity and pH value

            5. 2.5. Viscosity and surface tension

            6. 2.6. Relative density and bulk density

            7. 2.7. Storage stability and shelf-life: effects of temperature on technical characteristics...

            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, spontaneity of dispersion and dispersion stability

               4. 2.8.4. Degree of dissolution and dilution stability

               5. 2.8.5. Particle size distribution, dust content, attrition and mechanical stability

                  1. 2.8.5.1. Particle size distribution

                  2. 2.8.5.2. Dust content

                  3. 2.8.5.3. Attrition

                  4. 2.8.5.4. Hardness and integrity

               6. 2.8.6. Emulsifiability, re-emulsifiability, emulsion stability

               7. 2.8.7. Flowability, pourability and dustability

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

            10. 2.10. Adherence and distribution to seeds

            11. 2.11. Other studies

         3. SECTION 3 Data on application

            1. 3.1. Field of use envisaged

            2. 3.2. Effects on harmful organisms

            3. 3.3. Details of intended use

            4. 3.4. Application rate and concentration of the active substance

            5. 3.5. Method of application

            6. 3.6. Number and timing of applications and duration of protection

            7. 3.7. Necessary waiting periods or other precautions to avoid phytotoxic effects...

            8. 3.8. Proposed instructions for use

         4. SECTION 4 Further information on the plant protection product

            1. 4.1. Safety intervals and other precautions to protect humans, animals and...

            2. 4.2. Recommended methods and precautions

            3. 4.3. Emergency measures in the case of an accident

            4. 4.4. Packaging, compatibility of the plant protection product with proposed packaging...

            5. 4.5. Procedures for destruction or decontamination of the plant protection product...

               1. 4.5.1. Neutralisation procedures

               2. 4.5.2. Controlled incineration

         5. SECTION 5 Analytical methods

            1. Introduction

            2. 5.1. Methods used for the generation of pre-authorisation data

               1. 5.1.1. Methods for the analysis of the plant protection product

               2. 5.1.2. Methods for the determination of residues

            3. 5.2. Methods for post-authorisation control and monitoring purposes

         6. SECTION 6 Efficacy data

            1. Introduction

               1. 1. The data supplied shall be sufficient to permit an evaluation...

               2. 2. The number of trials to be conducted and reported shall...

               3. 3. Sufficient data shall be submitted to confirm that patterns of...

               4. 4. In order to assess seasonal differences, if any, sufficient data...

               5. 5. If the trials from the first season adequately confirm the...

            2. 6.1. Preliminary tests

            3. 6.2. Testing effectiveness

               1. Test conditions

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

            5. 6.4. Adverse effects on treated crops

               1. 6.4.1. Phytotoxicity to target plants (including different cultivars), or to target...

                  1. Test conditions

               2. 6.4.2. Effects on the yield of treated plants or plant products...

                  1. Circumstances in which required

               3. 6.4.3. Effects on the quality of plants or plant product

               4. 6.4.4. Effects on transformation processes

               5. 6.4.5. Impact on treated plants or plant products to be used...

                  1. Circumstances in which required

            6. 6.5. Observations on other undesirable or unintended side-effects

               1. 6.5.1. Impact on succeeding crops

                  1. Circumstances in which required

               2. 6.5.2. Impact on other plants, including adjacent crops

                  1. Circumstances in which required

               3. 6.5.3. Effects on beneficial and other non-target organisms

         7. SECTION 7 Toxicological studies

            1. Introduction

               1. 1. For the evaluation of the toxicity of the plant protection...

               2. 2. Consideration shall be given to the possible effects of components...

            2. 7.1. Acute toxicity

               1. 7.1.1. Oral toxicity

                  1. Circumstances in which required

               2. 7.1.2. Dermal toxicity

                  1. Circumstances in which required

               3. 7.1.3. Inhalation toxicity

                  1. Circumstances in which required

               4. 7.1.4. Skin irritation

                  1. Circumstances in which required

               5. 7.1.5. Eye irritation

                  1. Circumstances in which required

               6. 7.1.6. Skin sensitisation

                  1. Circumstances in which required

               7. 7.1.7. Supplementary studies on the plant protection product

               8. 7.1.8. Supplementary studies for combinations of plant protection products

            3. 7.2. Data on exposure

               1. 7.2.1. Operator exposure

                  1. 7.2.1.1. Estimation of operator exposure

                     1. Circumstances in which required

                     2. Estimation conditions

                  2. 7.2.1.2. Measurement of operator exposure

                     1. Circumstances in which required

               2. 7.2.2. Bystander and resident exposure

                  1. 7.2.2.1 Estimation of bystander and resident exposure

                     1. Circumstances in which required

                     2. Estimation conditions

                  2. 7.2.2.2. Measurement of bystander and resident exposure

                     1. Circumstances in which required

               3. 7.2.3. Worker exposure

                  1. 7.2.3.1. Estimation of worker exposure

                     1. Circumstances in which required

                     2. Estimation conditions

                  2. 7.2.3.2. Measurement of worker exposure

                     1. Circumstances in which required

            4. 7.3. Dermal absorption

               1. Circumstances in which required

               2. Test conditions

            5. 7.4. Available toxicological data relating to co-formulants

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

         9. SECTION 9 Fate and behaviour in the environment

            1. Introduction

               1. 1. Predicted environmental concentrations (PEC).

               2. 1.1. A realistic worst-case estimation shall be made of the expected...

               3. 1.2. For the purposes of the estimation of such concentrations the...

               4. 1.3. For the estimation of these concentrations all relevant information on...

               5. 1.4. When models are used for estimation of predicted environmental concentrations...

               6. 1.5. The information provided shall, where relevant, include that referred to...

               7. 2. For solid plant protection products, treated and coated seeds there...

            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. Circumstances in which required

                     2. Test conditions

                  2. 9.1.1.2. Field studies

                     1. 9.1.1.2.1. Soil dissipation studies

                        1. Circumstances in which required

                        2. Test conditions

                     2. 9.1.1.2.2. Soil accumulation studies

                        1. Circumstances in which required

                        2. Test conditions

               2. 9.1.2. Mobility in soil

                  1. 9.1.2.1. Laboratory studies

                     1. Circumstances in which required

                     2. Test conditions

                  2. 9.1.2.2. Lysimeter studies

                     1. Circumstances in which required

                     2. Test conditions

                  3. 9.1.2.3. Field leaching studies

                     1. Circumstances in which required

                     2. Test conditions

               3. 9.1.3. Estimation of concentrations in soil

            3. 9.2. Fate and behaviour in water and sediment

               1. 9.2.1. Aerobic mineralisation in surface water

                  1. Circumstances in which required

                  2. Test conditions

               2. 9.2.2. Water/sediment study

                  1. Circumstances in which required

                  2. Test conditions

               3. 9.2.3. Irradiated water/sediment study

                  1. Test conditions

               4. 9.2.4. Estimation of concentrations in groundwater

                  1. 9.2.4.1. Calculation of concentrations in groundwater

                  2. 9.2.4.2. Additional field tests

               5. 9.2.5. Estimation of concentrations in surface water and sediment

            4. 9.3. Fate and behaviour in air

               1. 9.3.1. Route and rate of degradation in air and transport via...

            5. 9.4. Estimation of concentrations for other routes of exposure

         10. SECTION 10 Ecotoxicological studies

             1. Introduction

                1. 1. Testing of the plant protection product shall be necessary where...

                2. 2. All potentially adverse effects found during routine ecotoxicological investigations shall...

                3. 3. Whenever a study implies the use of different doses, the...

                4. 4. Where exposure data are necessary to decide whether a study...

                5. 5. The requirements laid down in this Section shall include certain...

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

                7. 7. In order to facilitate the assessment of the significance of...

                8. 8. The ecotoxicological assessment shall be based on the risk that...

                9. 9. For those guidelines which allow for study to be designed...

                10. 10. For solid formulations an assessment of the risk from dust...

                11. 11. Higher tier studies using a plant protection product shall be...

                12. 12. Pending the validation and adoption of new studies and of...

             2. 10.1. Effects on birds and other terrestrial vertebrates

                1. 10.1.1. Effects on birds

                   1. 10.1.1.1. Acute oral toxicity to birds

                      1. Circumstances in which required

                      2. Test conditions

                   2. 10.1.1.2. Higher tier data on birds

                2. 10.1.2. Effects on terrestrial vertebrates other than birds

                   1. 10.1.2.1. Acute oral toxicity to mammals

                      1. Circumstances in which required

                   2. 10.1.2.2. Higher tier data on mammals

                3. 10.1.3. Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)

             3. 10.2. Effects on aquatic organisms

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

                   1. Circumstances in which required

                   2. Test conditions

                2. 10.2.2. Additional long-term and chronic toxicity studies on fish, aquatic invertebrates...

                3. 10.2.3. Further testing on aquatic organisms

             4. 10.3. Effects on arthropods

                1. 10.3.1. Effects on bees

                   1. 10.3.1.1. Acute toxicity to bees

                      1. 10.3.1.1.1. Acute oral toxicity

                         1. Test conditions

                      2. 10.3.1.1.2. Acute contact toxicity

                         1. Test conditions

                   2. 10.3.1.2. Chronic toxicity to bees

                      1. Circumstances in which required

                      2. Test conditions

                   3. 10.3.1.3. Effects on honey bee development and other honey bee life...

                   4. 10.3.1.4. Sub-lethal effects

                   5. 10.3.1.5. Cage and tunnel tests

                      1. Circumstances in which required

                      2. Test conditions

                   6. 10.3.1.6. Field tests with honeybees

                      1. Circumstances in which required

                      2. Test conditions

                      3. Test guideline

                2. 10.3.2. Effects on non-target arthropods other than bees

                   1. Circumstances in which required

                   2. 10.3.2.1. Standard laboratory testing for non-target arthropods

                   3. 10.3.2.2. Extended laboratory testing, aged residue studies with non-target arthropods

                      1. Circumstances in which required

                      2. Test conditions

                         1. (a) Extended laboratory studies

                         2. (b) Aged residue studies

                   4. 10.3.2.3. Semi-field studies with non-target arthropods

                      1. Circumstances in which required

                      2. Test conditions

                   5. 10.3.2.4. Field studies with non-target arthropods

                      1. Circumstances in which required

                      2. Test conditions

                   6. 10.3.2.5. Other routes of exposure for non-target arthropods

             5. 10.4. Effects on non-target soil meso- and macrofauna

                1. 10.4.1. Earthworms

                   1. 10.4.1.1. Earthworms — sub-lethal effects

                      1. Circumstances in which required

                      2. Test conditions

                   2. 10.4.1.2. Earthworms — field studies

                      1. Circumstances in which required

                      2. Test conditions

                2. 10.4.2. Effects on non-target soil meso- and macrofauna (other than earthworms)...

                   1. Circumstances in which required

                   2. 10.4.2.1. Species level testing

                      1. Test conditions

                   3. 10.4.2.2. Higher tier testing

                      1. Circumstances in which required

                      2. Test conditions

             6. 10.5. Effects on soil nitrogen transformation

                1. Circumstances in which required

             7. 10.6. Effects on terrestrial non-target higher plants

                1. 10.6.1. Summary of screening data

                   1. Circumstances in which required

                   2. Test conditions

                2. 10.6.2. Testing on non-target plants

                   1. Circumstances in which required

                   2. Test conditions

                3. 10.6.3. Extended laboratory studies on non-target plants

                4. 10.6.4. Semi-field and field tests on non-target plants

             8. 10.7. Effects on other terrestrial organisms (flora and fauna)

             9. 10.8. Monitoring data

         11. SECTION 11 Literature data

         12. SECTION 12 Classification and labelling

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

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

            4. (iv) Whenever a study implies the use of different doses, the...

            5. (v) Where testing is done, a detailed description (specification) of the...

            6. (vi) In cases where a new preparation is to be dealt...

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

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

               3. (iii) Co-formulants must where possible, be identified either by their International...

               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) The physical and biological stability of the preparation at the...

                  2. (ii) Additionally in the case of liquid preparations, the effect of...

                  3. (iii) The shelf life of the preparation at the recommended storage...

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

                  3. (iii) The friability and attrition characteristics of granules, must be determined...

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

                  1. (i) The emulsifiability, emulsion stability and re-emulsifiability of preparations which form...

                  2. (ii) The stability of dilute emulsions and of preparations which are...

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

                  1. (i) The flowability of granular preparations must be determined and reported...

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

                  3. (iii) The dustability of dustable powders must be determined and reported...

            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) Packaging to be used must be fully described and specified...

               2. (ii) The suitability of the packaging, including closures, in terms of...

               3. (iii) The resistance of the packaging material to its contents must...

            2. 4.2. Procedures for cleaning application equipment

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

               1. (i) Where relevant pre-harvest intervals, re-entry periods or withholding periods necessary...

               2. (ii) Where necessary, in the light of the test results, information...

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

            5. 4.5. 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...

               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) The information provided, taken together with that for the micro-organism(s),...

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

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

                4. (iv) There is a need to report all potentially adverse effects...

                5. (v) In general, much of the data relating to impact on...

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

                7. (vii) In order to facilitate the assessment of the significance of...

             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