INHALT

Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, 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 283/2013
of 1 March 2013
setting out the data requirements for active substances, 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 active substances
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 ACTIVE SUBSTANCES
SECTION 1
Identity of the active substance
1.1.
Applicant
1.2.
Producer
1.3.
Common name proposed or ISO-accepted, and synonyms
1.4.
Chemical name (IUPAC and CA nomenclature)
1.5.
Producer's development code numbers
1.6.
CAS, EC and CIPAC numbers
1.7.
Molecular and structural formula, molar mass
1.8.
Method of manufacture (synthesis pathway) of the active substance
1.9.
Specification of purity of the active substance in g/kg
1.10.
Identity and content of additives (such as stabilisers) and impurities
1.10.1.
Additives
1.10.2.
Significant impurities
1.10.3.
Relevant impurities
1.11.
Analytical profile of batches
SECTION 2
Physical and chemical properties of the active substance
2.1.
Melting point and boiling point
2.2.
Vapour pressure, volatility
2.3.
Appearance (physical state, colour)
2.4.
Spectra (UV/VIS, IR, NMR, MS), molar extinction at relevant wavelengths, optical purity
2.5.
Solubility in water
2.6.
Solubility in organic solvents
2.7.
Partition coefficient n-octanol/water
2.8
Dissociation in water
2.9.
Flammability and self-heating
2.10.
Flash point
2.11.
Explosive properties
2.12.
Surface tension
2.13.
Oxidising properties
2.14.
Other studies
SECTION 3
Further information on the active substance
3.1.
Use of the active substance
3.2.
Function
3.3.
Effects on harmful organisms
3.4.
Field of use envisaged
3.5.
Harmful organisms controlled and crops or products protected or treated
3.6.
Mode of action
3.7.
Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies
3.8.
Methods and precautions concerning handling, storage, transport or fire
3.9.
Procedures for destruction or decontamination
3.10.
Emergency measures in case of an accident
SECTION 4
Analytical methods
Introduction
4.1.
Methods used for the generation of pre-approval data
4.1.1.
Methods for the analysis of the active substance as manufactured
4.1.2.
Methods for risk assessment
4.2.
Methods for post-approval control and monitoring purposes
SECTION 5
Toxicological and metabolism studies
Introduction
5.1.
Studies on absorption, distribution, metabolism and excretion in mammals
5.1.1.
Absorption, distribution, metabolism and excretion after exposure by oral route
5.1.2.
Absorption, distribution, metabolism and excretion after exposure by other routes
5.2.
Acute toxicity
5.2.1.
Oral
Circumstances in which required
5.2.2.
Dermal
Circumstances in which required
5.2.3.
Inhalation
Circumstances in which required
5.2.4.
Skin irritation
Circumstances in which required
5.2.5.
Eye irritation
Circumstances in which required
5.2.6.
Skin sensitisation
Circumstances in which required
5.2.7.
Phototoxicity
Circumstances in which required
5.3.
Short-term toxicity
5.3.1.
Oral 28-day study
Circumstances in which required
5.3.2.
Oral 90-day study
Circumstances in which required
5.3.3.
Other routes
Circumstances in which required
5.4.
Genotoxicity testing
5.4.1. In vitro
studies
Circumstances in which required
5.4.2. In vivo
studies in somatic cells
Circumstances in which required
5.4.3. In vivo
studies in germ cells
Circumstances in which required
5.5.
Long-term toxicity and carcinogenicity
Circumstances in which required
Test conditions
5.6.
Reproductive toxicity
5.6.1.
Generational studies
Circumstances in which required
5.6.2.
Developmental toxicity studies
Circumstances in which required
Test conditions
5.7.
Neurotoxicity studies
5.7.1.
Neurotoxicity studies in rodents
Circumstances in which required
5.7.2.
Delayed polyneuropathy studies
Circumstances in which required
5.8.
Other toxicological studies
5.8.1.
Toxicity studies of metabolites
5.8.2.
Supplementary studies on the active substance
5.8.3.
Endocrine disrupting properties
5.9.
Medical data
5.9.1.
Medical surveillance on manufacturing plant personnel and monitoring studies
5.9.2.
Data collected on humans
5.9.3.
Direct observations
5.9.4.
Epidemiological studies
5.9.5.
Diagnosis of poisoning (determination of active substance, metabolites), specific signs of poisoning, clinical tests
5.9.6.
Proposed treatment: first aid measures, antidotes, medical treatment
5.9.7.
Expected effects of poisoning
SECTION 6
Residues in or on treated products, food and feed
6.1.
Storage stability of residues
Circumstances in which required
Test conditions
6.2.
Metabolism, distribution and expression of residues
6.2.1.
Plants
Circumstances in which required
Test conditions
6.2.2.
Poultry
Circumstances in which required
Test conditions
6.2.3.
Lactating ruminants
Circumstances in which required
Test conditions
6.2.4.
Pigs
Circumstances in which required
Test conditions
6.2.5.
Fish
Circumstances in which required
6.3.
Magnitude of residue trials in plants
Circumstances in which required
Test conditions
6.4.
Feeding studies
Circumstances in which required
6.4.1.
Poultry
6.4.2.
Ruminants
6.4.3.
Pigs
6.4.4.
Fish
6.5.
Effects of processing
6.5.1.
Nature of the residue
Circumstances in which required
Test conditions
6.5.2.
Distribution of the residue in inedible peel and pulp
Circumstances in which required
Test conditions
6.5.3.
Magnitude of residues in processed commodities
Circumstances in which required
Industrial processing
Domestic processing
Test conditions
6.6.
Residues in rotational crops
6.6.1.
Metabolism in rotational crops
Circumstances in which required
Test conditions
6.6.2.
Magnitude of residues in rotational crops
Circumstances in which required
Test conditions
6.7.
Proposed residue definitions and maximum residue levels
6.7.1.
Proposed residue definitions
6.7.2.
Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed
6.7.3.
Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed for imported products (import tolerance)
6.8.
Proposed safety intervals
6.9.
Estimation of the potential and actual exposure through diet and other sources
6.10.
Other studies
6.10.1.
Residue level in pollen and bee products
SECTION 7
Fate and behaviour in the environment
7.1.
Fate and behaviour in soil
7.1.1.
Route of degradation in soil
7.1.1.1.
Aerobic degradation
Circumstances in which required
Test conditions
7.1.1.2.
Anaerobic degradation
Circumstances in which required
Test conditions
7.1.1.3.
Soil photolysis
Circumstances in which required
7.1.2.
Rate of degradation in soil
7.1.2.1.
Laboratory studies
7.1.2.1.1.
Aerobic degradation of the active substance
Circumstances in which required
Test conditions
7.1.2.1.2.
Aerobic degradation of metabolites, breakdown and reaction products
Circumstances in which required
Test conditions
7.1.2.1.3.
Anaerobic degradation of the active substance
Circumstances in which required
Test conditions
7.1.2.1.4.
Anaerobic degradation of metabolites, breakdown and reaction products
Circumstances in which required
Test conditions
7.1.2.2.
Field studies
7.1.2.2.1.
Soil dissipation studies
Circumstances in which required
Test conditions
7.1.2.2.2.
Soil accumulation studies
Circumstances in which required
Test conditions
7.1.3.
Adsorption and desorption in soil
7.1.3.1.
Adsorption and desorption
7.1.3.1.1.
Adsorption and desorption of the active substance
Circumstances in which required
Test conditions
7.1.3.1.2.
Adsorption and desorption of metabolites, breakdown and reaction products
Circumstances in which required
Test conditions
7.1.3.2.
Aged sorption
Circumstances in which required
Test conditions
7.1.4.
Mobility in soil
7.1.4.1.
Column leaching studies
7.1.4.1.1.
Column leaching of the active substance
Circumstances in which required
7.1.4.1.2.
Column leaching of metabolites, breakdown and reaction products
Circumstances in which required
7.1.4.2.
Lysimeter studies
Circumstances in which required
Test conditions
7.1.4.3.
Field leaching studies
Circumstances in which required
Test conditions
7.2.
Fate and behaviour in water and sediment
7.2.1.
Route and rate of degradation in aquatic systems (chemical and photochemical degradation)
7.2.1.1.
Hydrolytic degradation
Circumstances in which required
Test conditions
7.2.1.2.
Direct photochemical degradation
Circumstances in which required
Test conditions
7.2.1.3.
Indirect photochemical degradation
Circumstances in which required
Test conditions
7.2.2.
Route and rate of biological degradation in aquatic systems
7.2.2.1. ‘
Ready biodegradability
’
Circumstances in which required
7.2.2.2.
Aerobic mineralisation in surface water
Circumstances in which required
Test conditions
7.2.2.3.
Water/sediment study
Circumstances in which required
Test conditions
7.2.2.4.
Irradiated water/sediment study
Circumstances in which required
Test conditions
7.2.3.
Degradation in the saturated zone
7.3.
Fate and behaviour in air
7.3.1.
Route and rate of degradation in air
7.3.2.
Transport via air
Circumstances in which required
7.3.3.
Local and global effects
7.4.
Definition of the residue
7.4.1.
Definition of the residue for risk assessment
7.4.2.
Definition of the residue for monitoring
7.5.
Monitoring data
SECTION 8
Ecotoxicological studies
Introduction
8.1.
Effects on birds and other terrestrial vertebrates
8.1.1.
Effects on birds
8.1.1.1.
Acute oral toxicity to birds
Circumstances in which required
Test conditions
8.1.1.2.
Short-term dietary toxicity to birds
Circumstances in which required
Test conditions
8.1.1.3.
Sub-chronic and reproductive toxicity to birds
Circumstances in which required
Test conditions
8.1.2.
Effects on terrestrial vertebrates other than birds
8.1.2.1.
Acute oral toxicity to mammals
Circumstances in which required
8.1.2.2.
Long-term and reproductive toxicity to mammals
Circumstances in which required
8.1.3.
Active substance bioconcentration in prey of birds and mammals
8.1.4.
Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)
8.1.5.
Endocrine disrupting properties
8.2.
Effects on aquatic organisms
8.2.1.
Acute toxicity to fish
Circumstances in which required
Test conditions
8.2.2.
Long-term and chronic toxicity to fish
Circumstances in which required
8.2.2.1.
Fish early life stage toxicity test
8.2.2.2.
Fish full life cycle test
Test conditions
8.2.2.3.
Bioconcentration in fish
Circumstances in which required
8.2.3.
Endocrine disrupting properties
8.2.4.
Acute toxicity to aquatic invertebrates
Circumstances in which required
8.2.4.1.
Acute toxicity to
Daphnia magna
Test conditions
8.2.4.2.
Acute toxicity to an additional aquatic invertebrate species
Test conditions
8.2.5.
Long-term and chronic toxicity to aquatic invertebrates
Circumstances in which required
8.2.5.1.
Reproductive and development toxicity to
Daphnia magna
8.2.5.2.
Reproductive and development toxicity to an additional aquatic invertebrate species
8.2.5.3.
Development and emergence in
Chironomus riparius
Test conditions
8.2.5.4.
Sediment dwelling organisms
Test conditions
8.2.6.
Effects on algal growth
Circumstances in which required
8.2.6.1.
Effects on growth of green algae
Test conditions
8.2.6.2.
Effects on growth of an additional algal species
Test conditions
8.2.7.
Effects on aquatic macrophytes
Circumstances in which required
Test conditions
8.2.8.
Further testing on aquatic organisms
Circumstances in which required
Test conditions
8.3.
Effect on arthropods
8.3.1.
Effects on bees
8.3.1.1.
Acute toxicity to bees
8.3.1.1.1.
Acute oral toxicity
Test conditions
8.3.1.1.2.
Acute contact toxicity
Test conditions
8.3.1.2.
Chronic toxicity to bees
Circumstances in which required
Test conditions
8.3.1.3.
Effects on honeybee development and other honeybee life stages
Circumstances in which required
8.3.1.4.
Sub-lethal effects
8.3.2.
Effects on non-target arthropods other than bees
Circumstances in which required
8.3.2.1.
Effects on
Aphidius rhopalosiphi
Test conditions
8.3.2.2.
Effects on
Typhlodromus pyri
Test conditions
8.4.
Effects on non-target soil meso- and macrofauna
8.4.1.
Earthworm — sub-lethal effects
Circumstances in which required
Test conditions
8.4.2.
Effects on non-target soil meso- and macrofauna (other than earthworms)
Circumstances in which required
8.4.2.1.
Species level testing
Test conditions
8.5.
Effects on soil nitrogen transformation
Circumstances in which required
Test conditions
8.6.
Effects on terrestrial non-target higher plants
8.6.1.
Summary of screening data
Circumstances in which required
Test conditions
8.6.2.
Testing on non-target plants
Circumstances in which required
Test conditions
8.7.
Effects on other terrestrial organisms (flora and fauna)
8.8.
Effects on biological methods for sewage treatment
Circumstances in which required
8.9.
Monitoring data
SECTION 9
Literature data
SECTION 10
Classification and labelling
PART B
MICRO-ORGANISMS INCLUDING VIRUSES
Introduction
1. IDENTITY OF THE MICRO-ORGANISM
1.1.
Applicant
1.2.
Producer
1.3.
Name and species description, strain characterisation
1.4.
Specification of the material used for manufacturing of formulated products
1.4.1.
Content of the micro-organism
1.4.2.
Identity and content of impurities, additives, contaminating micro-organisms
1.4.3.
Analytical profile of batches
2. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM
2.1.
History of the micro-organism and its uses. Natural occurrence and geographical distribution
2.1.1.
Historical background
2.1.2.
Origin and natural occurrence
2.2.
Information on target organism(s)
2.2.1.
Description of the target organism(s)
2.2.2.
Mode of action
2.3.
Host specificity range and effects on species other than the target harmful organism
2.4.
Development stages/life cycle of the micro-organism
2.5.
Infectiveness, dispersal and colonisation ability
2.6.
Relationships to known plant or animal or human pathogens
2.7.
Genetic stability and factors affecting it
2.8.
Information on the production of metabolites (especially toxins)
2.9.
Antibiotics and other anti-microbial agents
3. FURTHER INFORMATION ON THE MICRO-ORGANISM
Introduction
3.1.
Function
3.2.
Field of use envisaged
3.3.
Crops or products protected or treated
3.4.
Method of production and quality control
3.5.
Information on the occurrence or possible occurrence of the development of resistance of the target organism(s)
3.6.
Methods to prevent loss of virulence of seed stock of the micro-organism
3.7.
Recommended methods and precautions concerning handling, storage, transport or fire
3.8.
Procedures for destruction or decontamination
3.9.
Measures in case of an accident
4. ANALYTICAL METHODS
Introduction
4.1.
Methods for the analysis of the micro-organism as manufactured
4.2.
Methods to determine and quantify residues (viable or non-viable)
5. EFFECTS ON HUMAN HEALTH
Introduction
TIER I
5.1.
Basic information
5.1.1.
Medical data
5.1.2.
Medical surveillance on manufacturing plant personnel
5.1.3.
Sensitisation/allergenicity observations, if appropriate
5.1.4.
Direct observation, e.g. clinical cases
5.2.
Basic studies
5.2.1.
Sensitisation
(20)
Aim of the test
Circumstances in which required
(21)
5.2.2.
Acute toxicity, pathogenicity and infectiveness
5.2.2.1.
Acute oral toxicity, pathogenicity and infectiveness
Circumstances in which required
5.2.2.2.
Acute inhalation toxicity, pathogenicity and infectiveness
Circumstances in which required
5.2.2.3.
Intraperitoneal/subcutaneous single dose
Circumstances in which required
5.2.3.
Genotoxicity testing
Circumstances in which required
Aim of the test
Test conditions
(23)
5.2.3.1.
In vitro
studies
Circumstances in which required
5.2.4.
Cell culture study
5.2.5.
Information on short-term toxicity and pathogenicity
Aim of the test
Circumstances in which required
5.2.5.1.
Health effects after repeated inhalatory exposure
Circumstances in which required
5.2.6.
Proposed treatment: first aid measures, medical treatment
TIER II
5.3.
Specific toxicity, pathogenicity and infectiveness studies
5.4.
In vivo
studies in somatic cells
Circumstances in which required
5.5.
Genotoxicity —
In vivo
studies in germ cells
Aim of the test and test conditions
Circumstances in which required
5.6.
Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation
6. RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED
Introduction
6.1.
Persistence and likelihood of multiplication in or on crops, feedingstuffs or foodstuffs
6.2.
Further information required
6.2.1.
Non-viable residues
6.2.2.
Viable residues
6.3.
Summary and evaluation of residue behaviour resulting from data submitted under points 6.1 and 6.2
7. FATE AND BEHAVIOUR IN THE ENVIRONMENT
Introduction
7.1.
Persistence and multiplication
7.1.1.
Soil
7.1.2.
Water
7.1.3.
Air
7.2.
Mobility
8. EFFECTS ON NON-TARGET ORGANISMS
Introduction
8.1.
Effects on birds
Aim of the test
8.2.
Effects on aquatic organisms
Aim of the test
8.2.1.
Effects on fish
Aim of the test
8.2.2.
Effects on freshwater invertebrates
Aim of the test
8.2.3.
Effects on algae growth
Aim of the test
8.2.4.
Effects on plants other than algae
Aim of the test
8.3.
Effects on bees
Aim of the test
8.4.
Effects on arthropods other than bees
Aim of the test
8.5.
Effects on earthworms
Aim of the test
8.6.
Effects on non-target soil micro-organisms
8.7.
Additional studies
9. SUMMARY AND EVALUATION OF ENVIRONMENTAL IMPACT