INHALT

Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Text with EEA relevance

COMMISSION REGULATION (EU) No 284/2013
of 1 March 2013
setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
(Text with EEA relevance)
Article 1
Data requirements for plant protection products
Article 2
Repeal
Article 3
Transitional measures as regards procedures concerning active substances
Article 4
Transitional measures as regards procedures concerning plant protection products
Article 5
Entry into force and date of application
ANNEX
INTRODUCTION
Information to be submitted, its generation and its presentation
3.
Good laboratory practice (GLP)
4.
Test material
5.
Tests on vertebrate animals
PART A
CHEMICAL PLANT PROTECTION PRODUCTS
SECTION 1
Identity of the plant protection product
1.1.
Applicant
1.2.
Producer of the plant protection product and of the active substances
1.3.
Trade name or proposed trade name and producer’s development code number of the plant protection product if appropriate
1.4.
Detailed quantitative and qualitative information on the composition of the plant protection product
1.4.1.
Composition of the plant protection product
1.4.2.
Information on the active substances
1.4.3.
Information on safeners, synergists and co-formulants
1.5.
Type and code of the plant protection product
1.6.
Function
SECTION 2
Physical, chemical and technical properties of the plant protection product
2.1.
Appearance
2.2.
Explosive and oxidising properties
2.3.
Flammability and self-heating
2.4.
Acidity/alkalinity and pH value
2.5.
Viscosity and surface tension
2.6.
Relative density and bulk density
2.7.
Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection product
2.8.
Technical characteristics of the plant protection product
2.8.1.
Wettability
2.8.2.
Persistent foaming
2.8.3.
Suspensibility, spontaneity of dispersion and dispersion stability
2.8.4.
Degree of dissolution and dilution stability
2.8.5.
Particle size distribution, dust content, attrition and mechanical stability
2.8.5.1.
Particle size distribution
2.8.5.2.
Dust content
2.8.5.3.
Attrition
2.8.5.4.
Hardness and integrity
2.8.6.
Emulsifiability, re-emulsifiability, emulsion stability
2.8.7.
Flowability, pourability and dustability
2.9.
Physical and chemical compatibility with other products including plant protection products with which its use is to be authorised
2.10.
Adherence and distribution to seeds
2.11.
Other studies
SECTION 3
Data on application
3.1.
Field of use envisaged
3.2.
Effects on harmful organisms
3.3.
Details of intended use
3.4.
Application rate and concentration of the active substance
3.5.
Method of application
3.6.
Number and timing of applications and duration of protection
3.7.
Necessary waiting periods or other precautions to avoid phytotoxic effects on succeeding crops
3.8.
Proposed instructions for use
SECTION 4
Further information on the plant protection product
4.1.
Safety intervals and other precautions to protect humans, animals and the environment
4.2.
Recommended methods and precautions
4.3.
Emergency measures in the case of an accident
4.4.
Packaging, compatibility of the plant protection product with proposed packaging materials
4.5.
Procedures for destruction or decontamination of the plant protection product and its packaging
4.5.1.
Neutralisation procedures
4.5.2.
Controlled incineration
SECTION 5
Analytical methods
Introduction
5.1.
Methods used for the generation of pre-authorisation data
5.1.1.
Methods for the analysis of the plant protection product
5.1.2.
Methods for the determination of residues
5.2.
Methods for post-authorisation control and monitoring purposes
SECTION 6
Efficacy data
Introduction
6.1.
Preliminary tests
6.2.
Testing effectiveness
Test conditions
6.3.
Information on the occurrence or possible occurrence of the development of resistance
6.4.
Adverse effects on treated crops
6.4.1.
Phytotoxicity to target plants (including different cultivars), or to target plant products
Test conditions
6.4.2.
Effects on the yield of treated plants or plant products
Circumstances in which required
6.4.3.
Effects on the quality of plants or plant product
6.4.4.
Effects on transformation processes
6.4.5.
Impact on treated plants or plant products to be used for propagation
Circumstances in which required
6.5.
Observations on other undesirable or unintended side-effects
6.5.1.
Impact on succeeding crops
Circumstances in which required
6.5.2.
Impact on other plants, including adjacent crops
Circumstances in which required
6.5.3.
Effects on beneficial and other non-target organisms
SECTION 7
Toxicological studies
Introduction
7.1.
Acute toxicity
7.1.1.
Oral toxicity
Circumstances in which required
7.1.2.
Dermal toxicity
Circumstances in which required
7.1.3.
Inhalation toxicity
Circumstances in which required
7.1.4.
Skin irritation
Circumstances in which required
7.1.5.
Eye irritation
Circumstances in which required
7.1.6.
Skin sensitisation
Circumstances in which required
7.1.7.
Supplementary studies on the plant protection product
7.1.8.
Supplementary studies for combinations of plant protection products
7.2.
Data on exposure
7.2.1.
Operator exposure
7.2.1.1.
Estimation of operator exposure
Circumstances in which required
Estimation conditions
7.2.1.2.
Measurement of operator exposure
Circumstances in which required
7.2.2.
Bystander and resident exposure
7.2.2.1
Estimation of bystander and resident exposure
Circumstances in which required
Estimation conditions
7.2.2.2.
Measurement of bystander and resident exposure
Circumstances in which required
7.2.3.
Worker exposure
7.2.3.1.
Estimation of worker exposure
Circumstances in which required
Estimation conditions
7.2.3.2.
Measurement of worker exposure
Circumstances in which required
7.3.
Dermal absorption
Circumstances in which required
Test conditions
7.4.
Available toxicological data relating to co-formulants
SECTION 8
Residues in or on treated products, food and feed
SECTION 9
Fate and behaviour in the environment
Introduction
9.1.
Fate and behaviour in soil
9.1.1.
Rate of degradation in soil
9.1.1.1.
Laboratory studies
Circumstances in which required
Test conditions
9.1.1.2.
Field studies
9.1.1.2.1.
Soil dissipation studies
Circumstances in which required
Test conditions
9.1.1.2.2.
Soil accumulation studies
Circumstances in which required
Test conditions
9.1.2.
Mobility in soil
9.1.2.1.
Laboratory studies
Circumstances in which required
Test conditions
9.1.2.2.
Lysimeter studies
Circumstances in which required
Test conditions
9.1.2.3.
Field leaching studies
Circumstances in which required
Test conditions
9.1.3.
Estimation of concentrations in soil
9.2.
Fate and behaviour in water and sediment
9.2.1.
Aerobic mineralisation in surface water
Circumstances in which required
Test conditions
9.2.2.
Water/sediment study
Circumstances in which required
Test conditions
9.2.3.
Irradiated water/sediment study
Test conditions
9.2.4.
Estimation of concentrations in groundwater
9.2.4.1.
Calculation of concentrations in groundwater
9.2.4.2.
Additional field tests
9.2.5.
Estimation of concentrations in surface water and sediment
9.3.
Fate and behaviour in air
9.3.1.
Route and rate of degradation in air and transport via air
9.4.
Estimation of concentrations for other routes of exposure
SECTION 10
Ecotoxicological studies
Introduction
10.1.
Effects on birds and other terrestrial vertebrates
10.1.1.
Effects on birds
10.1.1.1.
Acute oral toxicity to birds
Circumstances in which required
Test conditions
10.1.1.2.
Higher tier data on birds
10.1.2.
Effects on terrestrial vertebrates other than birds
10.1.2.1.
Acute oral toxicity to mammals
Circumstances in which required
10.1.2.2.
Higher tier data on mammals
10.1.3.
Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)
10.2.
Effects on aquatic organisms
10.2.1.
Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes.
Circumstances in which required
Test conditions
10.2.2.
Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms
10.2.3.
Further testing on aquatic organisms
10.3.
Effects on arthropods
10.3.1.
Effects on bees
10.3.1.1.
Acute toxicity to bees
10.3.1.1.1.
Acute oral toxicity
Test conditions
10.3.1.1.2.
Acute contact toxicity
Test conditions
10.3.1.2.
Chronic toxicity to bees
Circumstances in which required
Test conditions
10.3.1.3.
Effects on honey bee development and other honey bee life stages
10.3.1.4.
Sub-lethal effects
10.3.1.5.
Cage and tunnel tests
Circumstances in which required
Test conditions
10.3.1.6.
Field tests with honeybees
Circumstances in which required
Test conditions
Test guideline
10.3.2.
Effects on non-target arthropods other than bees
Circumstances in which required
10.3.2.1.
Standard laboratory testing for non-target arthropods
10.3.2.2.
Extended laboratory testing, aged residue studies with non-target arthropods
Circumstances in which required
Test conditions
(a) Extended laboratory studies
(b) Aged residue studies
10.3.2.3.
Semi-field studies with non-target arthropods
Circumstances in which required
Test conditions
10.3.2.4.
Field studies with non-target arthropods
Circumstances in which required
Test conditions
10.3.2.5.
Other routes of exposure for non-target arthropods
10.4.
Effects on non-target soil meso- and macrofauna
10.4.1.
Earthworms
10.4.1.1.
Earthworms — sub-lethal effects
Circumstances in which required
Test conditions
10.4.1.2.
Earthworms — field studies
Circumstances in which required
Test conditions
10.4.2.
Effects on non-target soil meso- and macrofauna (other than earthworms)
Circumstances in which required
10.4.2.1.
Species level testing
Test conditions
10.4.2.2.
Higher tier testing
Circumstances in which required
Test conditions
10.5.
Effects on soil nitrogen transformation
Circumstances in which required
10.6.
Effects on terrestrial non-target higher plants
10.6.1.
Summary of screening data
Circumstances in which required
Test conditions
10.6.2.
Testing on non-target plants
Circumstances in which required
Test conditions
10.6.3.
Extended laboratory studies on non-target plants
10.6.4.
Semi-field and field tests on non-target plants
10.7.
Effects on other terrestrial organisms (flora and fauna)
10.8.
Monitoring data
SECTION 11
Literature data
SECTION 12
Classification and labelling
PART B
PREPARATIONS OF MICRO-ORGANISMS INCLUDING VIRUSES
INTRODUCTION
1. IDENTITY OF THE PLANT PROTECTION PRODUCT
1.1.
Applicant
1.2.
Manufacturer of the preparation and the micro-organism(s)
1.3.
Trade name or proposed trade name, and manufacturer's development code number of the preparation if appropriate
1.4.
Detailed quantitative and qualitative information on the composition of the preparation
1.5.
Physical state and nature of the preparation
1.6.
Function
2. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT
2.1.
Appearance (colour and odour)
2.2.
Storage stability and shelf-life
2.2.1.
Effects of light, temperature and humidity on technical characteristics of the plant protection product
2.2.2.
Other factors affecting stability
2.3.
Explosivity and oxidising properties
2.4.
Flash point and other indications of flammability or spontaneous ignition
2.5.
Acidity, alkalinity and if necessary pH value
2.6.
Viscosity and surface tension
2.7.
Technical characteristics of the plant protection product
2.7.1.
Wettability
2.7.2.
Persistent foaming
2.7.3.
Suspensibility and suspension stability
2.7.4.
Dry sieve test and wet sieve test
2.7.5.
Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)
2.7.6.
Emulsifiability, re-emulsifiability, emulsion stability
2.7.7.
Flowability, pourability (rinsability) and dustability
2.8.
Physical, chemical and biological compatibility with other products including plant protection products with which its use is to be authorised
2.8.1.
Physical compatibility
2.8.2.
Chemical compatibility
2.8.3.
Biological compatibility
2.9.
Adherence and distribution to seeds
2.10.
Summary and evaluation of data presented under points 2.1 to 2.9
3. DATA ON APPLICATION
3.1.
Field of use envisaged
3.2.
Mode of action
3.3.
Details of intended use
3.4.
Application rate
3.5.
Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed)
3.6.
Method of application
3.7.
Number and timing of applications and duration of protection
3.8.
Necessary waiting periods or other precautions to avoid phytopathogenic effects on succeeding crops
3.9.
Proposed instructions for use
4. FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT
4.1.
Packaging and compatibility of the preparation with proposed packaging materials
4.2.
Procedures for cleaning application equipment
4.3.
Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment
4.4.
Recommended methods and precautions concerning: handling, storage, transport or fire
4.5.
Measures in the case of an accident
4.6.
Procedures for destruction or decontamination of the plant protection product and its packaging
4.6.1.
Controlled incineration
4.6.2.
Others
5. ANALYTICAL METHODS
Introduction
5.1.
Methods for the analysis of the preparation
5.2.
Methods to determine and quantify residues
6. EFFICACY DATA
General
6.1.
Preliminary tests
6.2.
Testing effectiveness
Aim of the tests
Test conditions
Test guideline
6.3.
Information on the occurrence or possible occurrence of the development of resistance
6.4.
Effects on the yield of treated plants or plant products in terms of quantity and/or quality
6.4.1.
Effects on the quality of plants or plant products
Aim of the tests
Circumstances in which required
6.4.2.
Effects on transformation processes
Aim of the tests
Circumstances in which required
6.4.3.
Effects on the yield of treated plants or plant products
Aim of the tests
Circumstances in which required
6.5.
Phytotoxicity to target plants (including different cultivars), or to target plant products
Aim of the tests
Circumstances in which required
Test guideline
6.6.
Observations on undesirable or unintended side-effects, e. g. on beneficial and other non-target organisms, on succeeding crops, other plants or parts of treated plants used for propagating purposes (e. g. seeds, cuttings, runners)
6.6.1.
Impact on succeeding crops
Aim of the information required
Circumstances in which required
6.6.2.
Impact on other plants, including adjacent crops
Aim of the information required
Circumstances in which required
6.6.3.
Impact on treated plants or plant products to be used for propagation
Aim of the information required
Circumstances in which required
Test guideline
6.6.4.
Effects on beneficial and other non-target organisms
6.7.
Summary and evaluation of data presented under 6.1 to 6.6
7. EFFECTS ON HUMAN HEALTH
7.1.
Basic acute toxicity studies
7.1.1.
Acute oral toxicity
Circumstances in which required
Test method
7.1.2.
Acute inhalation toxicity
Aim of the test
Circumstances in which required
Test method
7.1.3.
Acute percutaneous toxicity
Circumstances in which required
Test method
7.2.
Additional acute toxicity studies
7.2.1.
Skin irritation
Aim of the test
Circumstances in which required
Test method
7.2.2.
Eye irritation
Aim of the test
Circumstances in which required
Test method
7.2.3.
Skin sensitisation
Aim of the test
Circumstances in which required
Test method
7.3.
Data on exposure
7.4.
Available toxicological data relating to non-active substances
7.5.
Supplementary studies for combinations of plant protection products
Aim of the test
7.6.
Summary and evaluation of health effects
8. RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED
9. FATE AND BEHAVIOUR IN THE ENVIRONMENT
10. EFFECTS ON NON-TARGET ORGANISMS
Introduction
10.1.
Effects on birds
10.2.
Effects on aquatic organisms
10.3.
Effects on bees
10.4.
Effects on arthropods other than bees
10.5.
Effects on earthworms
10.6.
Effects on soil micro-organisms
10.7.
Additional studies
11. SUMMARY AND EVALUATION OF ENVIRONMENTAL IMPACT