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Guidelines and supporting documents on Active Substances and Plant Protection Products
Guidelines and supporting documents on Active Substances and Plant Protection Products
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Active Substance Part A (chemicals)
Active Substance Part B (micro-organisms)
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Section(s)
0: General Guidance (283-A)
1: Identity of the active substance (283-A)
1.1: Applicant (283-A)
1.2: Producer (283-A)
1.3: Common name proposed or ISO-accepted and synonyms (283-A)
1.4: Chemical name (IUPAC and CA nomenclature) (283-A)
1.5: Producer's development code numbers (283-A)
1.6: CAS, EC and CIPAC numbers (283-A)
1.7: Molecular and structural formula, molar mass (283-A)
1.8: Method of manufacture (synthesis pathway) of the active substance (283-A)
1.9: Specification of purity of the active substance in g/kg (283-A)
1.10: Identity and content of additives (such as stabilisers) and impurities (283-A)
1.10.1: Additives (283-A)
1.10.2: Significant impurities (283-A)
1.10.3: Relevant impurities (283-A)
1.11: Analytical profile of batches (283-A)
2: Physical and chemical properties of the active substance (283-A)
2.1: Melting point and boiling point (283-A)
2.2: Vapour pressure, volatility (283-A)
2.3: Appearance (physical state, colour) (283-A)
2.4: Spectra (UV/VIS, IR, NMR, MS), molar extinction at relevant wavelengths, optical purity (283-A)
2.5: Solubility in water (283-A)
2.6: Solubility in organic solvents (283-A)
2.7: Partition coefficient n-octanol/water (283-A)
2.8: Dissociation in water (283-A)
2.9: Flammability and self-heating (283-A)
2.10: Flash point (283-A)
2.11: Explosive properties (283-A)
2.12: Surface tension (283-A)
2.13: Oxidising properties (283-A)
2.14: Other studies (283-A)
3: Further information on the active substance (283-A)
3.1: Use of the active substance (283-A)
3.2: Function (283-A)
3.3: Effects on harmful organisms (283-A)
3.4: Field of use envisaged (283-A)
3.5: Harmful organisms controlled and crops or products protected or treated (283-A)
3.6: Mode of action (283-A)
3.7: Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies (283-A)
3.8: Methods and precautions concerning handling, storage, transport or fire (283-A)
3.9: Procedures for destruction or decontamination (283-A)
3.10: Emergency measures in case of an accident (283-A)
4: Analytical methods (283-A)
4.1: Methods used for the generation of pre-approval data (283-A)
4.1.1: Methods for the analysis of the active substance as manufactured (283-A)
4.1.2: Methods for risk assessment (283-A)
4.2: Methods for post-approval control and monitoring purposes (283-A)
5: Toxicological and metabolism studies (283-A)
5.1: Studies on absorption, distribution, metabolism and excretion in mammals (283-A)
5.1.1: Absorption, distribution, metabolism and excretion after exposure by oral route (283-A)
5.1.2: Absorption, distribution, metabolism and excretion after exposure by other routes (283-A)
5.2: Acute toxicity (283-A)
5.2.1: Oral (283-A)
5.2.2: Dermal (283-A)
5.2.3: Inhalation (283-A)
5.2.4: Skin irritation (283-A)
5.2.5: Eye irritation (283-A)
5.2.6: Skin sensitisation (283-A)
5.2.7: Phototoxicity (283-A)
5.3: Short-term toxicity (283-A)
5.3.1: Oral 28-day study (283-A)
5.3.2: Oral 90-day study (283-A)
5.3.3: Other routes (283-A)
5.4: Genotoxicity testing (283-A)
5.4.1: In vitro studies (283-A)
5.4.2: In vivo studies in somatic cells (283-A)
5.4.3: In vivo studies in germ cells (283-A)
5.5: Long-term toxicity and carcinogenicity (283-A)
5.6: Reproductive toxicity (283-A)
5.6.1: Generational studies (283-A)
5.6.2: Developmental toxicity studies (283-A)
5.7: Neurotoxicity studies (283-A)
5.7.1: Neurotoxicity studies in rodents (283-A)
5.7.2: Delayed polyneuropathy studies (283-A)
5.8: Other toxicological studies (283-A)
5.8.1: Toxicity studies of metabolites (283-A)
5.8.2: Supplementary studies on the active substance (283-A)
5.8.3: Endocrine disrupting properties (283-A)
5.9: Medical data (283-A)
5.9.1: Medical surveillance on manufacturing plant personnel and monitoring studies (283-A)
5.9.2: Data collected on humans (283-A)
5.9.3: Direct observations (283-A)
5.9.4: Epidemiological studies (283-A)
5.9.5: Diagnosis of poisoning (determination of active substance, metabolites), specific signs of poisoning, clinical tests (283-A)
5.9.6: Proposed treatment: first aid measures, antidotes, medical treatment (283-A)
5.9.7: Expected effects of poisoning (283-A)
6: Residues in or on treated products, food and feed (283-A)
6.1: Storage stability of residues (283-A)
6.2: Metabolism, distribution and expression of residues (283-A)
6.2.1: Plants (283-A)
6.2.2: Poultry (283-A)
6.2.3: Lactating ruminants (283-A)
6.2.4: Pigs (283-A)
6.2.5: Fish (283-A)
6.3: Magnitude of residue trials in plants (283-A)
6.4: Feeding studies (283-A)
6.4.1: Poultry (283-A)
6.4.2: Ruminants (283-A)
6.4.3: Pigs (283-A)
6.4.4: Fish (283-A)
6.5: Effects of processing (283-A)
6.5.1: Nature of the residue (283-A)
6.5.2: Distribution of the residue in inedible peel and pulp (283-A)
6.5.3: Magnitude of residues in processed commodities (283-A)
6.6: Residues in rotational crops (283-A)
6.6.1: Metabolism in rotational crops (283-A)
6.6.2: Magnitude of residues in rotational crops (283-A)
6.7: Proposed residue definitions and maximum residue levels (283-A)
6.7.1: Proposed residue definitions (283-A)
6.7.2: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed (283-A)
6.7.3: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed for imported products (import tolerance) (283-A)
6.8: Proposed safety intervals (283-A)
6.9: Estimation of the potential and actual exposure through diet and other sources (283-A)
6.10: Other studies (283-A)
6.10.1: Residue level in pollen and bee products (283-A)
7: Fate and behaviour in the environment (283-A)
7.1: Fate and behaviour in soil (283-A)
7.1.1: Route of degradation in soil (283-A)
7.1.1.1: Aerobic degradation (283-A)
7.1.1.2: Anaerobic degradation (283-A)
7.1.1.3: Soil photolysis (283-A)
7.1.2: Rate of degradation in soil (283-A)
7.1.2.1: Laboratory studies (283-A)
7.1.2.1.1: Aerobic degradation of the active substance (283-A)
7.1.2.1.2: Aerobic degradation of metabolites, breakdown and reaction products (283-A)
7.1.2.1.3: Anaerobic degradation of the active substance (283-A)
7.1.2.1.4: Anaerobic degradation of metabolites, breakdown and reaction products (283-A)
7.1.2.2: Field studies (283-A)
7.1.2.2.1: Soil dissipation studies (283-A)
7.1.2.2.2: Soil accumulation studies (283-A)
7.1.3: Adsorption and desorption in soil (283-A)
7.1.3.1: Adsorption and desorption (283-A)
7.1.3.1.1: Adsorption and desorption of the active substance (283-A)
7.1.3.1.2: Adsorption and desorption of metabolites, breakdown and reaction products (283-A)
7.1.3.2: Aged sorption (283-A)
7.1.4: Mobility in soil (283-A)
7.1.4.1: Column leaching studies (283-A)
7.1.4.1.1: Column leaching of the active substance (283-A)
7.1.4.1.2: Column leaching of metabolites, breakdown and reaction products (283-A)
7.1.4.2: Lysimeter studies (283-A)
7.1.4.3: Field leaching studies (283-A)
7.2: Fate and behaviour in water and sediment (283-A)
7.2.1: Route and rate of degradation in aquatic systems (chemical and photochemical degradation) (283-A)
7.2.1.1: Hydrolytic degradation (283-A)
7.2.1.2: Direct photochemical degradation (283-A)
7.2.1.3: Indirect photochemical degradation (283-A)
7.2.2: Route and rate of biological degradation in aquatic systems (283-A)
7.2.2.1: ‘Ready biodegradability’ (283-A)
7.2.2.2: Aerobic mineralisation in surface water (283-A)
7.2.2.3: Water/sediment study (283-A)
7.2.2.4: Irradiated water/sediment study (283-A)
7.2.3: Degradation in the saturated zone (283-A)
7.3: Fate and behaviour in air (283-A)
7.3.1: Route and rate of degradation in air (283-A)
7.3.2: Transport via air (283-A)
7.3.3: Local and global effects (283-A)
7.4: Definition of the residue (283-A)
7.4.1: Definition of the residue for risk assessment (283-A)
7.4.2: Definition of the residue for monitoring (283-A)
7.5: Monitoring data (283-A)
8: Ecotoxicological studies (283-A)
8.1: Effects on birds and other terrestrial vertebrates (283-A)
8.1.1: Effects on birds (283-A)
8.1.1.1: Acute oral toxicity to birds (283-A)
8.1.1.2: Short-term dietary toxicity to birds (283-A)
8.1.1.3: Sub-chronic and reproductive toxicity to birds (283-A)
8.1.2: Effects on terrestrial vertebrates other than birds (283-A)
8.1.2.1: Acute oral toxicity to mammals (283-A)
8.1.2.2: Long-term and reproductive toxicity to mammals (283-A)
8.1.3: Active substance bioconcentration in prey of birds and mammals (283-A)
8.1.4: Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians) (283-A)
8.1.5: Endocrine disrupting properties (283-A)
8.2: Effects on aquatic organisms (283-A)
8.2.1: Acute toxicity to fish (283-A)
8.2.2: Long-term and chronic toxicity to fish (283-A)
8.2.2.1: Fish early life stage toxicity test (283-A)
8.2.2.2: Fish full life cycle test (283-A)
8.2.2.3: Bioconcentration in fish (283-A)
8.2.3: Endocrine disrupting properties (283-A)
8.2.4: Acute toxicity to aquatic invertebrates (283-A)
8.2.4.1: Acute toxicity to Daphnia magna (283-A)
8.2.4.2: Acute toxicity to an additional aquatic invertebrate species (283-A)
8.2.5: Long-term and chronic toxicity to aquatic invertebrates (283-A)
8.2.5.1: Reproductive and development toxicity to Daphnia magna (283-A)
8.2.5.2: Reproductive and development toxicity to an additional aquatic invertebrate species (283-A)
8.2.5.3: Development and emergence in Chironomus riparius (283-A)
8.2.5.4: Sediment dwelling organisms (283-A)
8.2.6: Effects on algal growth (283-A)
8.2.6.1: Effects on growth of green algae (283-A)
8.2.6.2: Effects on growth of an additional algal species (283-A)
8.2.7: Effects on aquatic macrophytes (283-A)
8.2.8: Further testing on aquatic organisms (283-A)
8.3: Effect on arthropods (283-A)
8.3.1: Effects on bees (283-A)
8.3.1.1: Acute toxicity to bees (283-A)
8.3.1.1.1: Acute oral toxicity (283-A)
8.3.1.1.2: Acute contact toxicity (283-A)
8.3.1.2: Chronic toxicity to bees (283-A)
8.3.1.3: Effects on honeybee development and other honeybee life stages (283-A)
8.3.1.4: Sub-lethal effects (283-A)
8.3.2: Effects on non-target arthropods other than bees (283-A)
8.3.2.1: Effects on Aphidius rhopalosiphi (283-A)
8.3.2.2: Effects on Typhlodromus pyri (283-A)
8.4: Effects on non-target soil meso- and macrofauna (283-A)
8.4.1: Earthworm — sub-lethal effects (283-A)
8.4.2: Effects on non-target soil meso- and macrofauna (other than earthworms) (283-A)
8.4.2.1: Species level testing (283-A)
8.5: Effects on soil nitrogen transformation (283-A)
8.6: Effects on terrestrial non-target higher plants (283-A)
8.6.1: Summary of screening data (283-A)
8.6.2: Testing on non-target plants (283-A)
8.7: Effects on other terrestrial organisms (flora and fauna) (283-A)
8.8: Effects on biological methods for sewage treatment (283-A)
8.9: Monitoring data (283-A)
9: Literature data (283-A)
10: Classification and labelling (283-A)
0: General Guidance (283-B)
1: Identity of the applicant, identity of the active substance and manufacturing information (283-B)
1.1: Applicant (283-B)
1.2: Producer (283-B)
1.3: Identity, taxonomy and phylogeny of the micro-organism (283-B)
1.4: Specification of the microbial pest control agent as manufactured (283-B)
1.4.1: Content of the active substance (283-B)
1.4.2: Identity and quantification of additives, relevant contaminating micro-organisms and relevant impurities (283-B)
1.4.2.1: Identity and quantification of additives (283-B)
1.4.2.2: Identity and content of relevant contaminating micro-organisms (283-B)
1.4.2.3: Identity and quantification of relevant impurities (283-B)
1.4.3: Analytical profile of batches (283-B)
1.5: Information on manufacturing process and control measures for the active substance (283-B)
1.5.1: Production and quality control (283-B)
1.5.2: Recommended methods and precautions concerning handling, storage, transport or fire (283-B)
1.5.3: Procedures for destruction or decontamination (283-B)
2: Biological properties of the micro-organism (283-B)
2.1: Origin, occurrence and history of use (283-B)
2.1.1: Origin and isolation source (283-B)
2.1.2: Occurrence (283-B)
2.1.3: History of use (283-B)
2.2: Ecology and life cycle of the micro-organism (283-B)
2.3: Mode of action on the target organism and host range (283-B)
2.4: Growth requirements (283-B)
2.5: Infectivity to the target organism (283-B)
2.6: Relationship to known human pathogens and to pathogens to non-target organisms (283-B)
2.7: Genetic stability and factors affecting it (283-B)
2.8: Information on metabolites of concern (283-B)
2.9: Presence of transferable antimicrobial resistance genes (283-B)
3: Further information (283-B)
3.1: Function and target organism (283-B)
3.2: Field of use envisaged (283-B)
3.3: Crops or products protected or treated (283-B)
3.4: Information on possible development of resistance in the target organism(s) (283-B)
3.5: Literature data (283-B)
4: Analytical methods (283-B)
4.1: Methods for the analysis of the MPCA as manufactured (283-B)
4.2: Methods to determine the density of the micro-organism and quantify residues (283-B)
5: Effects on human health (283-B)
5.1: Medical data (283-B)
5.1.1: Therapeutic and first aid measures (283-B)
5.1.2: Medical surveillance (283-B)
5.1.3: Information on sensitisation and allergenicity (283-B)
5.1.4: Direct observation (283-B)
5.2: Assessment on potential infectivity and pathogenicity of the micro-organism to humans (283-B)
5.3: Infectivity and pathogenicity studies on the micro-organism (283-B)
5.3.1: Infectivity and pathogenicity (283-B)
5.3.1.1: Oral infectivity and pathogenicity (283-B)
5.3.1.2: Intratracheal/ intranasal infectivity and pathogenicity (283-B)
5.3.1.3: Intravenous, intraperitoneal or subcutaneous single exposure (283-B)
5.3.2: Cell culture study (283-B)
5.4: Specific infectivity and pathogenicity studies on the micro-organism (283-B)
5.5: Information and toxicity studies on metabolites (283-B)
5.5.1: Information on metabolites (283-B)
5.5.2: Additional toxicity studies on metabolites of concern (283-B)
6: Residues in or on treated products, food and feed (283-B)
6.1: Estimation of consumer exposure to residues (283-B)
6.2: Data generation on residues (283-B)
7: Environmental occurrence of the micro-organism, including fate and behaviour of metabolites of concern (283-B)
7.1: Environmental occurrence of the micro-organism (283-B)
7.1.1: Predicted environmental density of the micro-organism (283-B)
7.1.1.1: Soil (283-B)
7.1.1.2: Water (283-B)
7.1.2: Exposure to micro-organisms known to be pathogenic either for plants or for other organisms (283-B)
7.1.3: Qualitative exposure assessment of the micro-organism (283-B)
7.1.4: Experimental exposure data of the micro-organism (283-B)
7.2: Fate and behaviour of metabolite(s) of concern (283-B)
7.2.1: Predicted environmental concentration (283-B)
7.2.2: Qualitative exposure assessment (283-B)
7.2.3: Experimental exposure data (283-B)
8: Ecotoxicological studies (283-B)
8.1: Effects on terrestrial vertebrates (283-B)
8.2: Effects on aquatic organisms (283-B)
8.2.1: Effects on fish (283-B)
8.2.2: Effects on aquatic invertebrates (283-B)
8.2.3: Effects on algae (283-B)
8.2.4: Effects on aquatic macrophytes (283-B)
8.3: Effects on bees (283-B)
8.4: Effects on non-target arthropods other than bees (283-B)
8.5: Effects on non-target meso- and macro-organisms in soil (283-B)
8.6: Effects on non-target terrestrial plants (283-B)
8.7: Additional studies on the micro-organism (283-B)
8.8: Information and toxicity studies on metabolites (283-B)
8.8.1: Information on metabolites (283-B)
8.8.2: Additional toxicity studies on metabolites of concern (283-B)
0: General Guidance (284-A)
1: Identity of the plant protection product (284-A)
1.1: Applicant (284-A)
1.2: Producer of the plant protection product and the active substances (284-A)
1.3: Trade name or proposed trade name and producer’s development code number of the plant protection product if appropriate (284-A)
1.4: Detailed quantitative and qualitative information on the composition of the plant protection product (284-A)
1.4.1: Composition of the plant protection product (284-A)
1.4.2: Information on the active substances (284-A)
1.4.3: Information on safeners, synergists and co-formulants (284-A)
1.5: Type and code of the plant protection product (284-A)
1.6: Function (284-A)
2: Physical, chemical and technical properties of the plant protection product (284-A)
2.1: Appearance (284-A)
2.2: Explosive and oxidising properties (284-A)
2.3: Flammability and self-heating (284-A)
2.4: Acidity/alkalinity and pH value (284-A)
2.5: Viscosity and surface tension (284-A)
2.6: Relative density and bulk density (284-A)
2.7: Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection product (284-A)
2.8: Technical characteristics of the plant protection product (284-A)
2.8.1: Wettability (284-A)
2.8.2: Persistent foaming (284-A)
2.8.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-A)
2.8.4: Degree of dissolution and dilution stability (284-A)
2.8.5: Particle size distribution, dust content, attrition and mechanical stability (284-A)
2.8.5.1: Particle size distribution (284-A)
2.8.5.2: Dust content (284-A)
2.8.5.3: Attrition (284-A)
2.8.5.4: Hardness and integrity (284-A)
2.8.6: Emulsifiability, re-emulsifiability, emulsion stability (284-A)
2.8.7: Flowability, pourability and dustability (284-A)
2.9: Physical and chemical compatibility with other products including plant protection products with which its use is to be authorised (284-A)
2.10: Adherence and distribution to seeds (284-A)
2.11: Other studies (284-A)
3: Data on application (284-A)
3.1: Field of use envisaged (284-A)
3.2: Effects on harmful organisms (284-A)
3.3: Details of intended use (284-A)
3.4: Application rate and concentration of the active substance (284-A)
3.5: Method of application (284-A)
3.6: Number and timing of applications and duration of protection (284-A)
3.7: Necessary waiting periods or other precautions to avoid phytotoxic effects on succeeding crops (284-A)
3.8: Proposed instructions for use (284-A)
4: Further information on the plant protection product (284-A)
4.1: Safety intervals and other precautions to protect humans, animals and the environment (284-A)
4.2: Recommended methods and precautions (284-A)
4.3: Emergency measures in the case of an accident (284-A)
4.4: Packaging, compatibility of the plant protection product with proposed packaging materials (284-A)
4.5: Procedures for destruction or decontamination of the plant protection product and its packaging (284-A)
4.5.1: Neutralisation procedures (284-A)
4.5.2: Controlled incineration (284-A)
5: Analytical methods (284-A)
5.1: Methods used for the generation of pre-authorisation data (284-A)
5.1.1: Methods for the analysis of the plant protection product (284-A)
5.1.2: Methods for the determination of residues (284-A)
5.2: Methods for post-authorisation control and monitoring purposes (284-A)
6: Efficacy data (284-A)
6.1: Preliminary tests (284-A)
6.2: Testing effectiveness (284-A)
6.3: Information on the occurrence or possible occurrence of the development of resistance (284-A)
6.4: Adverse effects on treated crops (284-A)
6.4.1: Phytotoxicity to target plants (including different cultivars), or to target plant products (284-A)
6.4.2: Effects on the yield of treated plants or plant products (284-A)
6.4.3: Effects on the quality of plants or plant product (284-A)
6.4.4: Effects on transformation processes (284-A)
6.4.5: Impact on treated plants or plant products to be used for propagation (284-A)
6.5: Observations on other undesirable or unintended side-effects (284-A)
6.5.1: Impact on succeeding crops (284-A)
6.5.2: Impact on other plants, including adjacent crops (284-A)
6.5.3: Effects on beneficial and other non-target organisms (284-A)
7: Toxicological studies (284-A)
7.1: Acute toxicity (284-A)
7.1.1: Oral toxicity (284-A)
7.1.2: Dermal toxicity (284-A)
7.1.3: Inhalation toxicity (284-A)
7.1.4: Skin irritation (284-A)
7.1.5: Eye irritation (284-A)
7.1.6: Skin sensitisation (284-A)
7.1.7: Supplementary studies on the plant protection product (284-A)
7.1.8: Supplementary studies for combinations of plant protection products (284-A)
7.2: Data on exposure (284-A)
7.2.1: Operator exposure (284-A)
7.2.1.1: Estimation of operator exposure (284-A)
7.2.1.2: Measurement of operator exposure (284-A)
7.2.2: Bystander and resident exposure (284-A)
7.2.2.1: Estimation of bystander and resident exposure (284-A)
7.2.2.2: Measurement of bystander and resident exposure (284-A)
7.2.3: Worker exposure (284-A)
7.2.3.1: Estimation of worker exposure (284-A)
7.2.3.2: Measurement of worker exposure (284-A)
7.3: Dermal absorption (284-A)
7.4: Available toxicological data relating to co-formulants (284-A)
8: Residues in or on treated products, food and feed (284-A)
9: Fate and behaviour in the environment (284-A)
9.1: Fate and behaviour in soil (284-A)
9.1.1: Rate of degradation in soil (284-A)
9.1.1.1: Laboratory studies (284-A)
9.1.1.2: Field studies (284-A)
9.1.1.2.1: Soil dissipation studies (284-A)
9.1.1.2.2: Soil accumulation studies (284-A)
9.1.2: Mobility in the soil (284-A)
9.1.2.1: Laboratory studies (284-A)
9.1.2.2: Lysimeter studies (284-A)
9.1.2.3: Field leaching studies (284-A)
9.1.3: Estimation of concentrations in soil (284-A)
9.2: Fate and behaviour in water and sediment (284-A)
9.2.1: Aerobic mineralisation in surface water (284-A)
9.2.2: Water/sediment study (284-A)
9.2.3: Irradiated water/sediment study (284-A)
9.2.4: Estimation of concentrations in groundwater (284-A)
9.2.4.1: Calculation of concentrations in groundwater (284-A)
9.2.4.2: Additional field tests (284-A)
9.2.5: Estimation of concentrations in surface water and sediment (284-A)
9.3: Fate and behaviour in air (284-A)
9.3.1: Route and rate of degradation in air and transport via air (284-A)
9.4: Estimation of concentrations for other routes of exposure (284-A)
10: Ecotoxicological studies (284-A)
10.1: Effects on birds and other terrestrial vertebrates (284-A)
10.1.1: Effects on birds (284-A)
10.1.1.1: Acute oral toxicity to birds (284-A)
10.1.1.2: Higher tier data on birds (284-A)
10.1.2: Effects on terrestrial vertebrates other than birds (284-A)
10.1.2.1: Acute oral toxicity to mammals (284-A)
10.1.2.2: Higher tier data on mammals (284-A)
10.1.3: Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (284-A)
10.2: Effects on aquatic organisms (284-A)
10.2.1: Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes (284-A)
10.2.2: Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms (284-A)
10.2.3: Further testing on aquatic organisms (284-A)
10.3: Effects on arthropods (284-A)
10.3.1: Effects on bees (284-A)
10.3.1.1: Acute toxicity to bees (284-A)
10.3.1.1.1: Acute oral toxicity (284-A)
10.3.1.1.2: Acute contact toxicity (284-A)
10.3.1.2: Chronic toxicity to bees (284-A)
10.3.1.3: Effects on honey bee development and other honey bee life stages (284-A)
10.3.1.4: Sub-lethal effects (284-A)
10.3.1.5: Cage and tunnel tests (284-A)
10.3.1.6: Field tests with honeybees (284-A)
10.3.2: Effects on non-target arthropods other than bees (284-A)
10.3.2.1: Standard laboratory testing for non-target arthropods (284-A)
10.3.2.2: Extended laboratory testing, aged residue studies with non-target arthropods (284-A)
10.3.2.3: Semi-field studies with non-target arthropods (284-A)
10.3.2.4: Field studies with non-target arthropods (284-A)
10.3.2.5: Other routes of exposure for non-target arthropods (284-A)
10.4: Effects on non-target soil meso- and macrofauna (284-A)
10.4.1: Earthworms (284-A)
10.4.1.1: Earthworms — sub-lethal effects (284-A)
10.4.1.2: Earthworms — field studies (284-A)
10.4.2: Effects on non-target soil meso- and macrofauna (other than earthworms) (284-A)
10.4.2.1: Species level testing (284-A)
10.4.2.2: Higher tier testing (284-A)
10.5: Effects on soil nitrogen transformation (284-A)
10.6: Effects on terrestrial non-target higher plants (284-A)
10.6.1: Summary of screening data (284-A)
10.6.2: Testing on non-target plants (284-A)
10.6.3: Extended laboratory studies on non-target plants (284-A)
10.6.4: Semi-field and field tests on non-target plants (284-A)
10.7: Effects on other terrestrial organisms (flora and fauna) (284-A)
10.8: Monitoring data (284-A)
11: Literature data (284-A)
12: Classification and labelling (284-A)
0: General Guidance (284-B)
1: Identity of the applicant, identity of the plant protection product and manufacturing information (284-B)
1.1: Applicant (284-B)
1.2: Producer of the preparation and the micro-organism(s) (284-B)
1.3: Trade name or proposed trade name, and producer’s development code number of the preparation if appropriate (284-B)
1.4: Detailed quantitative and qualitative information on the composition of the preparation (284-B)
1.5: Physical state and nature of the preparation (284-B)
1.6: Method of production of the preparation and quality control (284-B)
1.7: Packaging and compatibility of the preparation with proposed packaging materials (284-B)
2: Physical, chemical and technical properties of the plant protection product (284-B)
2.1: Appearance (colour and odour) (284-B)
2.2: Explosivity and oxidising properties (284-B)
2.3: Flash point and other indications of flammability or spontaneous ignition (284-B)
2.4: Acidity, alkalinity and if necessary pH value (284-B)
2.5: Viscosity and surface tension (284-B)
2.6: Storage stability and shelf life (284-B)
2.6.1: Use concentration (284-B)
2.6.2: Effects of temperature and packaging (284-B)
2.6.3: Other factors affecting stability (284-B)
2.7: Technical characteristics of the plant protection product (284-B)
2.7.1: Wettability (284-B)
2.7.2: Persistent foaming (284-B)
2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-B)
2.7.4: Dry sieve test and wet sieve test (284-B)
2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) (284-B)
2.7.6: Emulsifiability, re-emulsifiability and emulsion stability (284-B)
2.7.7: Flowability, pourability (rinsability) and dustability (284-B)
2.8: Physical and chemical compatibility with other plant protection products including plant protection products with which its use is to be authorised (284-B)
2.8.1: Physical compatibility (284-B)
2.8.2: Chemical compatibility (284-B)
2.9: Adherence and distribution to seeds (284-B)
3: Data on application (284-B)
3.1: Field of use envisaged (284-B)
3.2: Mode of action on the target organism (284-B)
3.3: Function, target organisms and plants or plants products to be protected and possible risk mitigation measures (284-B)
3.4: Application rate (284-B)
3.5: Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed) (284-B)
3.6: Method of application (284-B)
3.7: Number and timing of applications on the same crop, duration of protection and waiting period(s) (284-B)
3.8: Proposed instructions for use (284-B)
3.9: Safety intervals and other precautions to protect human health, animal health and the environment (284-B)
4: Further information on the plant protection product (284-B)
4.1: Procedures for cleaning and decontaminating of application equipment (284-B)
4.2: Recommended methods and precautions concerning: handling, storage, transport, fire or use (284-B)
4.3: Measures in case of accident (284-B)
4.4: Procedures for destruction or decontamination of the plant protection product and its packaging (284-B)
4.4.1: Controlled incineration (284-B)
4.4.2: Others (284-B)
5: Analytical methods (284-B)
5.1: Methods for the analysis of the preparation (284-B)
5.2: Methods to determine and quantify residues (284-B)
6: Efficacy data (284-B)
6.1: Preliminary tests (284-B)
6.2: Minimum effective dose (284-B)
6.3: Testing effectiveness (284-B)
6.4: Information on possible development of resistance in target organisms (284-B)
6.5: Adverse effects on treated crops (284-B)
6.5.1: Phytotoxicity to target plants (including different cultivars), or to target plant products (284-B)
6.5.2: Effects on the yield of treated plants or plant products (284-B)
6.5.3: Effects on the quality of plants or plant products (284-B)
6.5.4: Effects on transformation processes (284-B)
6.5.5: Impact on treated plants or plant propagating material (284-B)
6.6: Observations on undesirable or unintended side-effects on succeeding crops and other plants (284-B)
6.6.1: Impact on succeeding crops (284-B)
6.6.2: Impact on other plants, including adjacent crops (284-B)
6.7: Compatibility in plant protection programmes (284-B)
7: Effect on human health (284-B)
7.1: Medical data (284-B)
7.2: Assessment of potential toxicity of the plant protection product (284-B)
7.3: Acute toxicity (284-B)
7.3.1: Acute oral toxicity (284-B)
7.3.2: Acute dermal toxicity (284-B)
7.3.3: Acute inhalation toxicity (284-B)
7.3.4: Skin irritation (284-B)
7.3.5: Eye irritation (284-B)
7.3.6: Skin sensitisation (284-B)
7.4: Additional toxicity information (284-B)
7.5: Data on exposure (284-B)
7.6: Available toxicological data relating to non-active substances (284-B)
7.7: Supplementary studies for combinations of plant protection products (284-B)
8: Residues in or on treated products, food and feed (284-B)
9: Fate and behaviour in the environment (284-B)
10: Effects on non-target organisms (284-B)
10.1: Effects on terrestrial vertebrates (284-B)
10.2: Effects on aquatic organisms (284-B)
10.2.1: Effects on fish (284-B)
10.2.2: Effects on aquatic invertebrates (284-B)
10.2.3: Effects on algae (284-B)
10.2.4: Effects on aquatic macrophytes (284-B)
10.3: Effects on bees (284-B)
10.4: Effects on non-target arthropods other than bees (284-B)
10.5: Effects on non-target meso- and macroorganisms in soil (284-B)
10.6: Effects on non-target terrestrial plants (284-B)
10.7: Additional toxicity studies (284-B)
Author(s)
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AGRI
CANADA
CIPAC
COM
COMMISSION
CRC
Croplife
DE
ECHA
EFSA
EPA
EPPO
EURL
FAO
FOCUS
ICH
ISO
NAFTA
OECD
RIVM
SANTE
SETAC
UN RTDG
Unknown
WHO
WHO/FAO
ZONALNORTH
new author
Document type(s)
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Procedural guidance document- dossier and draft assessment report
Procedural guidance document- other
Procedural guidance document- post approval issues
external scientific report
monitoring
scientific opinion
scientific report
statement
technical GD
technical report
working document
workshop report
zonal GD
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Yes
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1255
Compendium of conditions of use to reduce exposure and risk from plant protection products (PAFF-PPL-March 2024-Doc.A.07.02)
No
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guidance document
COMMISSION
https://food.ec.europa.eu/document/download/cdd9b6c4-29dc-4077-a118-3e51c0abeb80_en?filename=pesticides_ppp_app-proc_guide_horiz_comp-cond.pdf
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