Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requi... (32013R0283)
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
Feedback