Plant Protection Products
PPP Part A (chemicals)
- Guidance Document on botanical active substances used in plant protection products (SANCO/11470/2012) Website guidance document
- Guidance document on semiochemical active substances and plant protection products (SANTE/12815/2014) Website guidance document
- ECHA Guidance on the Application of the CLP Criteria Website guidance document
- Commission Notice of 10.10.2017: Guidance on monitoring and surveying of impacts of pesticide use on human health and the environment under Article 7(3) of Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides (referred to as the Sustainable Use Directive) Website guidance document
- OECD Guidance Document on Developing and Assessing Adverse Outcome Pathways. Series on Testing and Assessment No. 184 Website guidance document
- OECD Guidance Document for Describing Non-Guideline In-vitro Test Methods,. Series on Testing and Assessment, No. 211 Website guidance document
- EFSA Guidance on Uncertainty Analysis in Scientific Assessments (EFSA Journal 2018;16(1):5123) Website Noted by SCoPAFF guidance document
- EFSA Guidance on the assessment of the biological relevance of data in scientific assessments (EFSA Journal 2017;15(8):4970) Website Noted by SCoPAFF guidance document
- EFSA Scientific Opinion on the guidance on the use of the weight of evidence approach in scientific assessments (EFSA Journal 2017;15(8):4971) Website Noted by SCoPAFF guidance document
- Guidance document for environmental risk assessments of active substances used on rice in the EU for Annex 1 inclusion (SANCO/1090/2000) Website guidance document
- EU Guidance document on significant and non-significant changes of the chemical composition of authorised plant protection products under Regulation (EC) No 1107/2009 of the EU Parliament and Council on placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (SANCO/12638/2011) Website guidance document
- OECD Guidance Documents on the Validation of (Quantitative) Structure-Activity Relationship [(Q)SAR] Models. Series on Testing and Assessment No. 69. Website guidance document
- OECD Guidance on Grouping of Chemicals, Second Edition. Series on Testing and Assessment, No. 194 Website guidance document
- OECD Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA) No. 260 Website guidance document
- OECD Consideration for assessing the risk of combined exposure to multiple chemicals. Series on Testing and Assessment No. 296 Website guidance document
- EFSA Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals (EFSA Journal 2019;17(3):5634) Website guidance document
- OECD Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests. Series on Testing & Assessment, No. 237 Website guidance document
- ECHA Practical Guide – how to use and report (Q)SARs Website guidance document
- EFSA Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Journal 2019;17(6):5708) Website guidance document
- Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health. (EFSA Journal 2021;19(8):6768) Website guidance document
- OECD Guidance Document on Good In Vitro Method Practices (GIVIMP) Website guidance document
- OECD Guidance document on the recognition, assessment, and use of clinical signs as humane endpoints for experimental animals used in safety evaluation. Series on Testing and Assessment. No19 Website guidance document
- ECHA. Read-Across Assessment Framework (RAAF), ECHA-17-R-01-EN Website guidance document
- EU Guidance Document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No. 1107/2009 (SANCO/10597/2003) Website guidance document
- WHO/FAO Pesticide Specifications. Manual on development and use of FAO and WHO specifications for chemical pesticides Website guidance document
- ECHA Guidance on the Application of the CLP Criteria Website guidance document
- WHO/FAO Pesticide Specifications. Manual on development and use of FAO and WHO specifications for chemical pesticides Website guidance document
- Guidance document for the generation and evaluation of data on the physical, chemical and technical properties of plant protection products under Regulation (EC) No. 1107/2009 (SANCO/10473/2003) Website guidance document
2.2: Explosive and oxidising properties
- Test methods according to Test series 1-3, Part I of the UN RTDG Manual of Tests and Criteria Website test method
- Test O.1: Test for oxidizing solids , Part III of UN RTDG Manual of Tests and Criteria Website test method
- Test O.2: Test for oxidizing liquids , Part III of UN RTDG Manual of Tests and Criteria Website test method
- Test O.3: Gravimetric test for oxidising solids, Part III of UN RTDG Manual of Tests and Criteria Website test method
- Method A.14 Explosive properties (Annex of Regulation (EC) No 440/2008). Website test method
- Method A.17 Oxidising properties (solids) (Annex of Regulation (EC) No 440/2008) Website test method
- Method A.21 Oxidising properties (liquids) (Annex of Regulation (EC) No 440/2008) Website test method
- Test method according to section 2.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008 Website test method
2.3: Flammability and self-heating
- OECD Guidance Document for flammability testing of plant protection and biocidal products, Series on Testing and Assessment, No. 330 Website guidance document
- Test N.1: test method for flammable solids, Part III of UN RTDG Manual of Tests and Criteria Website test method
- Method A.15 Auto-ignition temperature (liquids and gases), Part A of Commission Regulation (EC) No. 440/2008 Website test method
- Method A.16 Relative self-ignition temperature for solids, Part A of Commission Regulation (EC) No. 440/2008) Website test method
- Test N.4: test method for self-heating substances Part III of of UN RTDG Manual of Tests and Criteria Website test method
- Method A.9 Flash-point (Annex to Regulation (EC) No 440/2008) Website test method
- Test methods according to Table 2.6.3 of Part 2 of Annex I, Regulation (EC) No 1272/2008 (liquids) Website test method
- Method A.10 Flammability (Annex of Regulation (EC) No. 440/2008) for solids (solids) Website test method
- Method A.11 Flammability (Annex of Regulation (EC) No. 440/2008) for gaseous materials Website test method
- Method A.12 (Annex of Regulation (EC) No. 440/2008) for contact with water Website test method
- Test methods according to Section 2.2.4.1. of Part 2 of Annex I, to Regulation (EC) No 1272/2008 Website test method
- ISO/IEC 80079-20-1:2017 – Explosive atmospheres - Part 20-1: Material characteristics for gas and vapour classification - Test methods and data Website test method
- Test L.2: sustained combustibility test, Part III of the UN RTDG Manual of Tests and Criteria Website test method
2.4: Acidity/alkalinity and pH value
- CIPAC Method MT 75: Determination of pH values Website test method
- CIPAC Method MT 31: free acidity or alkalinity Website test method
- CIPAC Method MT 191: Acidity or alkalinity of formulations Website test method
- OECD Test Guideline 122 - Determination of pH, Acidity and Alkalinity Website test method
- Test methods according to Part III of the UN RTDG Manual of Tests and Criteria Website test method
2.5: Viscosity and surface tension
- OECD Test Guideline 115: Surface tension of aqueous solutions Website test method
- OECD Test Guideline 114 - Viscosity of Liquids Website test method
- CIPAC method MT 192: Viscosity of liquids by rotational viscosimetry Website test method
- Method A.5 Surface tension, (Annex of Commission Regulation (EC) No 440/2008) Website test method
2.6: Relative density and bulk density
- Method A.3 Relative density (Annex of Regulation (EC) No 440/2008). Website test method
- OECD Test Guideline 109 - Density of Liquids and Solids Website test method
- CIPAC Method MT 186: Bulk density Website test method
2.7: Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection product
- CIPAC Method MT 46: Accelerated storage procedure Website test method
- CIPAC MT 39 Stability of liquid formulations at 0˚C Website test method
2.8.1: Wettability
- CIPAC Method MT 53: Wettability Website test method
2.8.2: Persistent foaming
- CIPAC Method MT 47 Persistent foaming Website test method
2.8.3: Suspensibility, spontaneity of dispersion and dispersion stability
- CIPAC Method MT 184: Suspensibility of formulations forming suspensions on dilution with water Website test method
- CIPAC Method MT 160: Spontaneity of dispersion of suspension concentrates Website test method
- CIPAC Method MT 174: Dispersibility of water dispersible granules Website test method
- CIPAC Method MT 180: Dispersion stability of suspo-emulsion Website test method
2.8.4: Degree of dissolution and dilution stability
- CIPAC MT 41 Dilution stability of herbicide aqueous solutions Website test method
- CIPAC Method MT 196: Solution Properties of Water Soluble Tablets Website test method
2.8.5: Particle size distribution, dust content, attrition and mechanical stability
2.8.5.1: Particle size distribution
- CIPAC Method MT 185: Wet sieve test Website test method
- CIPAC Method MT 187: Particle size analysis by laser diffraction Website test method
- CIPAC Method MT 170: Dry sieve analysis of water dispersible granules Website test method
2.8.5.2: Dust content
2.8.5.3: Attrition
- CIPAC Method MT 178: Attrition resistance of granules Website test method
- CIPAC Method MT 193: Attrition of tablets Website test method
2.8.5.4: Hardness and integrity
2.8.6: Emulsifiability, re-emulsifiability, emulsion stability
2.8.7: Flowability, pourability and dustability
- CIPAC Method MT 148: Pourability of suspension concentrates, Website test method
- CIPAC Method MT 172: Flowability of granular preparations after accelerated storage under pressure Website test method
2.9: Physical and chemical compatibility with other products including plant protection products with which its use is to be authorised
- ASTM E1518 – 05: Standard Practice for Evaluation of Physical Compatibility of Pesticides in Aqueous Tank Mixtures by the Dynamic Shaker Method Website test method
2.10: Adherence and distribution to seeds
- CIPAC MT 175: Seed treatment formulations, liquid, determination of seed-seed uniformity of distribution Website test method
- CIPAC Method MT 194: Adhesion to Treated Seed Website test method
- European Seed Association, 2011. Assessment of free floating dust and abrasion particles of treated seeds as a parameter of the quality of treated seeds: Heubach test. ESA STAT Dust Working Group. Website test method
2.11: Other studies
- EPPO Global Database on Crops and Pests (EPPO, 2017) Website guidance document test method
- EPPO Standard PP1/239: Dose expression of plant protection products Website guidance document test method
- EPPO Standard PP1/240: Harmonized basic information for databases on plant protection products Website test method
- EPPO Standard PP1/248: Harmonized system for classification and coding of the uses of plant protection products Website guidance document test method
- EPPO Standard PP1/291: Evaluation of the influence of tank mix adjuvants on the efficacy of plant protection products Website test method
- EPPO Standard PP1/306: General principles for the development of co-formulated mixtures of plant protection products Website test method
- FAO Guidelines for the packaging and storage of pesticides (FAO, Rome, 1985) Website guidance document
- Guidance document for the generation and evaluation of data on the physical, chemical and technical properties of plant protection products under Regulation (EC) No. 1107/2009 (SANCO/10473/2003) Website guidance document
- EPPO Standard PP1/292: Cleaning pesticide application equipment (PAE) – efficacy aspects Website guidance document test method
- OECD Guidance Document on Pesticide Residue Analytical Methods. Environment, Health and Safety Publications. Series on Testing and Assessment No. 72. Series on Pesticides No. 39. Website guidance document
5.1.1: Methods for the analysis of the plant protection product
- Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/2013. (SANCO/3030/99) Website guidance document
5.1.2: Methods for the determination of residues
- Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE/2017/10632) Website guidance document
- Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830) Website guidance document
- OECD Guidance Document on Pesticide Residue Analytical Methods. Environment, Health and Safety Publications. Series on Testing and Assessment No. 72. Series on Pesticides No. 39. Website guidance document
5.2: Methods for post-authorisation control and monitoring purposes
- Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE/2017/10632) Website guidance document
- Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830) Website guidance document
- OECD Guidance Document on Pesticide Residue Analytical Methods. Environment, Health and Safety Publications. Series on Testing and Assessment No. 72. Series on Pesticides No. 39. Website guidance document
- Guidance document on the efficacy composition of core dossier and national addenda submitted to support the authorization of plant protection products under regulation (EC) No 1107/2009 of the EU Parliament and Council on placing of plant protection products on the market SANCO/10055/2013 Website guidance document
- EU guidance document on data requirements on efficacy for the dossier to be submitted for the approval of new active substances contained in plant protection products. (SANCO/10054/2013) Website guidance document
- EPPO standard series PP1: Efficacy evaluation of plant protection products Website guidance document test method
6.4.5: Impact on treated plants or plant products to be used for propagation
- ISTA Methods Website test method
7.1.1: Oral toxicity
- OECD Guidance document on acute oral toxicity testing. Series on Testing and Assessment, No. 24 Website guidance document
- OECD Guidance Document on using Cytotoxicity Tests to Estimate Starting Doses for Acute Oral Systemic Toxicity Tests. Series on Testing and Assessment, No. 129 Website guidance document
- OECD Test Guideline 420: Acute oral toxicity: fixed dose procedure Website test method
- OECD Test Guideline 423: Acute oral toxicity: acute toxic class method Website test method
- OECD Test Guideline 425: Acute oral toxicity: up-and-down procedure Website test method
- OECD Test Guideline No 401: Acute oral toxicity Website test method
7.1.2: Dermal toxicity
7.1.3: Inhalation toxicity
- OECD Test Guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method Website test method
- OECD Test Guideline 403: Acute Inhalation Toxicity Website test method
- OECD Guidance Document for the Derivation of an Acute Reference Concentration (Arfc). Series on Testing and Assessment, No. 153 Website guidance document
- OECD Test Guideline 433: Acute Inhalation Toxicity: Fixed Concentration Procedure Website test method
- OECD Guidance document on inhalation toxicity studies. Series on testing and assessment, No. 39 Website guidance document
7.1.4: Skin irritation
- OECD Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation. Series on Testing and Assessment, No. 203 Website guidance document
- OECD Test Guideline 431: In vitro Skin Corrosion: reconstructed human epidermis (RHE) test method Website test method
- OECD Test Guideline 435: In vitro Membrane Barrier Test Method for Skin Corrosion Website test method
- OECD Test Guideline 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method Website test method
- OECD Test Guideline 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) Website test method
- OECD Test Guideline 404: Acute Dermal Irritation/Corrosion Website test method
7.1.5: Eye irritation
- OECD Guidance Document on Integrated Approaches to Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation. Series on Testing and Assessment, No 263 Website guidance document
- OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants Website test method
- OECD Test Guideline 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage Website test method
- OECD Test Guideline 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage Website test method
- OECD Test Guideline 405: Acute eye irritation/corrosion Website test method
- OECD Guidance Document on the Bovine Corneal Opacity (BCOP) and Isolated Chicken Eye (ICE) Test Methods: Collection of Tissues for Histological Evaluation and Collection of Data on Non-severe Irritants. Series on Testing and Assessment, No. 160 Website guidance document
- OECD Test Guideline 492B. Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification Website test method
- OECD Test Guideline 467. Defined Approaches for Serious Eye Damage and Eye Irritation Website test method
- OECD Test Guideline 496: In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage Website test method
- OECD Test No. 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage Website test method
- OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage Website test method
- OECD Test Guideline 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage Website test method
7.1.6: Skin sensitisation
- OECD Test Guideline 442B: Skin Sensitisation – Local Lymph Node Assay: BrdU-ELISA Website test method
- OECD Test Guideline 429: Skin Sensitisation – Local Lymph Node Assay Website test method
- OECD Test Guideline 406: Skin sensitisation Website test method
- OECD Test Guideline 442A: Skin Sensitisation – Local Lymph Node Assay: DA Website test method
7.2: Data on exposure
- EFSA Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products (SANTE-10832-2015, EFSA Journal 2022;20(1):7032) Website Noted by SCoPAFF guidance document
7.2.1: Operator exposure
- OECD Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application, Series on Testing and Assessment No. 9 Website guidance document
7.2.3: Worker exposure
- OECD Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application, Series on Testing and Assessment No. 9 Website guidance document
7.3: Dermal absorption
- Guidance Document on clustering and ranking of emissions of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments (SANCO/12184/2014) Website Noted by SCoPAFF guidance document
9.1: Fate and behaviour in soil
- Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (based on -among others- Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)) Website Noted by SCoPAFF guidance document
- OECD Test Guideline 307: Aerobic and anaerobic transformation in soil Website test method
- ISO 10381-6:2009 Soil quality. Sampling. Guidance on the collection, handling and storage of soil under aerobic conditions for the assessment of microbiological processes, biomass and diversity in the laboratory test method
- ISO 18400-206:2018 Website test method
- ISO 18400-104:2018 Website test method
- ISO 18400-102:2017 Website test method
- ISO 18400-105:2017 Website test method
9.1.1.1: Laboratory studies
- DG SANCO Working Document on "Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides" Website guidance document
- OECD Test Guideline 307: Aerobic and anaerobic transformation in soil Website test method
9.1.1.2: Field studies
- OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides, No. 82 / Series on Testing and Assessment, No. 232. Website guidance document test method
9.1.2: Mobility in the soil
- Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU - Final Report of the Ground Water Work Group of FOCUS (Sanco/13144/2010) Website guidance document
9.1.2.1: Laboratory studies
- OECD Test Guideline 307: Aerobic and anaerobic transformation in soil Website test method
- OECD Test Guideline 106: Adsorption - Desorption Using a Batch Equilibrium Method Website test method
- OECD Test Guideline 121: Estimation of the Adsorption Coefficient (Koc ) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC) Website test method
- OECD Test Guideline 312: Leaching in Soil Columns Website test method
- Guidance documents reported in Section 7.1.2 and 7.1.3.1 of Annex I to Commission Communication C(2023) 6245 guidance document
9.1.2.2: Lysimeter studies
- OECD Guidance Document for the Performance Of Out-door Monolith Lysimeter Studies. Series on Testing and Assessment, No. 22 Website test method
9.1.2.3: Field leaching studies
- OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides, No. 82 / Series on Testing and Assessment, No. 232. Website guidance document test method
9.1.3: Estimation of concentrations in soil
- Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU - Final Report of the Ground Water Work Group of FOCUS (Sanco/13144/2010) Website guidance document
- Soil persistence models and EU registration, final report of the FOCUS Soil modelling workgroup, Sanco/7617/VI/96 Website guidance document
9.2: Fate and behaviour in water and sediment
- Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (based on -among others- Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)) Website Noted by SCoPAFF guidance document
9.2.1: Aerobic mineralisation in surface water
- DG SANCO Working Document on "Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides" Website guidance document
- OECD Test Guideline 309: Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test Website test method
9.2.2: Water/sediment study
- DG SANCO Working Document on "Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides" Website guidance document
- Generic Guidance for Surface Water Scenarios (based on -among others- “FOCUS Surface Water Scenarios in the EU Evaluation Process under 91/414/EEC"". Report of the FOCUS Working Group on Surface Water Scenarios, EC Document Reference (SANCO/4802/2001); Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (including Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)); Guidance Document on Tiered Risk Assessment for Plant Protection products for Aquatic Organisms in Edge-of-field Surface Waters in the Context of Regulation (EC) No 1107/2009 (SANTE-2015-00080); Landscape and Mitigation Factors in Aquatic Ecological Risk Assessment - Volume 1. Extended Summary and Recommendations - Final Report of the FOCUS Working Group on Landscape and Mitigation Factors in Ecological Risk Assessment (SANCO/10422/2005)) Website guidance document
- OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems Website test method
9.2.3: Irradiated water/sediment study
- OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems Website test method
9.2.4: Estimation of concentrations in groundwater
- EFSA guidance document on soil phototransformation products in groundwater – consideration, parameterisation and simulation in the exposure assessment of plant protection products (PAFF-PPL-Dec 22-Doc.A.07.02) Website Noted by SCoPAFF guidance document
- Generic guidance for Tier 1 FOCUS Ground water assessments (based on -–among others-- the European Commission (2014) Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU - Final Report of the Ground Water Work Group of FOCUS (Sanco/13144/2010); FOCUS (2000) “FOCUS groundwater scenarios in the EU review of active substances” Report of the FOCUS Groundwater Scenarios Workgroup (Sanco/321/2000); Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil.(doi: 10.2903/j.efsa.2008.622); Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (including Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)); section 3.3.1 of European Food Safety Authority. Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil (doi:10.2903/j.efsa.2017.4982); section 3.3 of Scientific report of EFSA on the ‘repair action’ of the FOCUS surface water scenarios (doi:10.2903/j.efsa.2020.6119)) Website guidance document
9.2.4.2: Additional field tests
- OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides, No. 82 / Series on Testing and Assessment, No. 232. Website guidance document test method
9.2.5: Estimation of concentrations in surface water and sediment
- Pesticides in Air: Considerations for Exposure Assessment”. Report of the FOCUS Working Group on Pesticides in Air (SANCO/10553/2006) Website guidance document
- Generic Guidance for Surface Water Scenarios (based on -among others- “FOCUS Surface Water Scenarios in the EU Evaluation Process under 91/414/EEC"". Report of the FOCUS Working Group on Surface Water Scenarios, EC Document Reference (SANCO/4802/2001); Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (including Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)); Guidance Document on Tiered Risk Assessment for Plant Protection products for Aquatic Organisms in Edge-of-field Surface Waters in the Context of Regulation (EC) No 1107/2009 (SANTE-2015-00080); Landscape and Mitigation Factors in Aquatic Ecological Risk Assessment - Volume 1. Extended Summary and Recommendations - Final Report of the FOCUS Working Group on Landscape and Mitigation Factors in Ecological Risk Assessment (SANCO/10422/2005)) Website guidance document
9.3: Fate and behaviour in air
- OECD Current approaches in the statistical analysis of ecotoxicity data: a guidance to application. Series of testing and assessment, No 54 Website guidance document
10.1: Effects on birds and other terrestrial vertebrates
- EFSA Risk assessment for birds and mammals (EFSA Journal 2009; 7(12):1438) Website guidance document
10.1.1.1: Acute oral toxicity to birds
- OECD Test Guideline No 223: Avian acute oral toxicity study Website test method
- US EPA OCSPP 850.2100: Avian oral toxicity test Website test method
10.1.2.1: Acute oral toxicity to mammals
- Please refer to 7.1.1. test method
10.1.3: Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)
- OECD Test Guideline 248: Xenopus Eleutheroembryonic Thyroid Assay (XETA) Website test method
- OECD Test Guideline 231: Amphibian Metamorphosis Assay Website test method
- OECD Test Guideline 241: Larval Amphibian Growth and Development Test Website test method
10.2: Effects on aquatic organisms
- Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge of field surface waters in the context of Regulation (EC) No 1107/2009 (SANTE-2015-00080) Website Noted by SCoPAFF guidance document
- OECD Guidance document on aqueous-phase aquatic toxicity testing of difficult test chemicals. Testing and Assessment, No. 23. (Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures) Website guidance document
10.2.1: Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes
- Guidance documents reported in point 8.2. of Annex I to Commission Communication C(2023) 6245 guidance document
- Where relevant, same test methods as reported in Section 8.2. of the Annex II to Commission Communication XXX/XXX [Publication Office: please insert the number of Commission Communication on data requirement for active substances] apply. test method
10.2.2: Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms
- Guidance documents reported in point 8.2.2. and 8.2.5. of Annex I to Commission Communication XXX/XXX [Publication Office: please insert the number of Commission Communication on data requirement for active substances] apply. guidance document
- Where relevant, same test methods as reported in points 8.2.2 and 8.2.5 of the Annex II to Commission Communication XXX/XXX [Publication Office: please insert the number of Commission Communication on data requirement for active substances] apply. test method
10.3: Effects on arthropods
- EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) Website guidance document
10.3.1.1.1: Acute oral toxicity
- EPPO 170(4) Side-effects on honeybees Website test method
- OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test Website test method
- OECD Test No. 247 Bumblebee, Acute Oral Toxicity Test Website test method
10.3.1.1.2: Acute contact toxicity
- EPPO 170(4) Side-effects on honeybees Website test method
- OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test Website test method
- OECD Test Guideline 246: Bumblebee, Acute Contact Toxicity Test Website test method
10.3.1.2: Chronic toxicity to bees
- OECD Test Guideline 245 Honey Bee (Apis mellifera l.), Chronic Oral Toxicity Test Website test method
10.3.1.3: Effects on honey bee development and other honey bee life stages
- OECD Guidance Document on the honeybee (Apis mellifera L.) brood test under semifield conditions (only for spray applications). Series on Testing and Assessment, No. 75 Website test method
- OECD Test Guideline No. 237 - Honey Bee (Apis mellifera) Larval Toxicity Test, Single Exposure Website test method
- Oomen PA, de Ruijter A and van der Steen J, 1992. Method for honeybee brood feeding tests with insect growth - regulating insecticides. Bulletin OEPP/EPPO Bulletin 22, 613-616. Website test method
- OECD Guidance Document on Honey Bee Larval Toxicity Test following Repeated Exposure. Series on Testing and Assessment, No. 239 Website test method
- Lückmann, J. and Schmitzer, S. (2019), The Oomen bee brood feeding test – revision of the method to current needs and developments. EPPO Bulletin, 49: 137– 146. Website test method
10.3.1.4: Sub-lethal effects
- OECD Guidance document on honey bee (Apis mellifera L.) homing flight test, using single oral exposure to sublethal doses of test chemical, Series on Testing and Assessment, No. 332. Website test method
10.3.1.5: Cage and tunnel tests
- EPPO 170(4) Side-effects on honeybees Website test method
- OECD Guidance Document on the honeybee (Apis mellifera L.) brood test under semifield conditions (only for spray applications). Series on Testing and Assessment, No. 75 Website test method
10.3.1.6: Field tests with honeybees
- Oomen PA, de Ruijter A and van der Steen J, 1992. Method for honeybee brood feeding tests with insect growth - regulating insecticides. Bulletin OEPP/EPPO Bulletin 22, 613-616. Website test method
- Lückmann, J. and Schmitzer, S. (2019), The Oomen bee brood feeding test – revision of the method to current needs and developments. EPPO Bulletin, 49: 137– 146. Website test method
10.3.2: Effects on non-target arthropods other than bees
- Candolfi et al (2001). Guidance Document on Regulatory Testing and Risk Assessment Procedures for Plant Protection Products With Non-Target Arthropods: From the Escort 2 Workshop (European Standard Characteristics of Non-Target Arthropod Regulatory Testing). SETAC press, pp 46. ISBN 1-880611-52-x Website guidance document
- De Jong et al. (2010) Guidance for summarising and evaluating field studies with non-target arthropods Website guidance document
10.3.2.1: Standard laboratory testing for non-target arthropods
- Guidelines to evaluate side-effects of plant protection products to non-target arthropods. (IOBC, BART and EPPO Joint Initiative. M.P. Candolfi, S. Blümel, R. Forster et al. (2000). ISBN: 92 9067 129-7) Website test method
10.3.2.2: Extended laboratory testing, aged residue studies with non-target arthropods
- An extended laboratory test for evaluating the effects of plant protection products on the parasitic wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae) - (Mead-Briggs, M.A., Moll, M., Grimm, et al (2010). BioControl 55:329-338) Website test method
- Guidelines to evaluate side-effects of plant protection products to non-target arthropods. (IOBC, BART and EPPO Joint Initiative. M.P. Candolfi, S. Blümel, R. Forster et al. (2000). ISBN: 92 9067 129-7) Website test method
10.3.2.3: Semi-field studies with non-target arthropods
- Guidelines to evaluate side-effects of plant protection products to non-target arthropods. (IOBC, BART and EPPO Joint Initiative. M.P. Candolfi, S. Blümel, R. Forster et al. (2000). ISBN: 92 9067 129-7) Website test method
10.3.2.4: Field studies with non-target arthropods
- Guidelines to evaluate side-effects of plant protection products to non-target arthropods. (IOBC, BART and EPPO Joint Initiative. M.P. Candolfi, S. Blümel, R. Forster et al. (2000). ISBN: 92 9067 129-7) Website test method
10.4: Effects on non-target soil meso- and macrofauna
- EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) Website guidance document
10.4.1.1: Earthworms — sub-lethal effects
- OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) Website test method
10.4.1.2: Earthworms — field studies
- De Jong et al (2006): Guidance for summarizing earthworm field studies. RIVM report No 601506006/2006 Website guidance document
- ISO 11268-3:2014: Soil quality - Effects of pollutants on earthworms -- Part 3: Guidance on the determination of effects in field situations Website test method
10.4.2: Effects on non-target soil meso- and macrofauna (other than earthworms)
- ISO 23611-2:2006 Soil Quality - Sampling of soil invertebrates - Part 2: Sampling and extraction of micro-arthropods (Collembola and Acarina) Website test method
10.4.2.1: Species level testing
- OECD Test No. 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil Website test method
- OECD Test Guideline 232: Collembolan Reproduction Test in Soil Website test method
10.5: Effects on soil nitrogen transformation
- EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) Website guidance document
- OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test Website test method
10.6: Effects on terrestrial non-target higher plants
- EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) Website guidance document
10.6.2: Testing on non-target plants
- OECD Test No. 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Website guidance document test method
- OECD Test No. 227 : Terrestrial Plant Test: Vegetative Vigour Test Website guidance document test method
10.6.3: Extended laboratory studies on non-target plants
- OECD Guidance Document on the honeybee (Apis mellifera L.) brood test under semifield conditions (only for spray applications). Series on Testing and Assessment, No. 75 Website test method
10.7: Effects on other terrestrial organisms (flora and fauna)
- EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) Website guidance document
- EFSA Application of systematic review methodology to food and feed safety assessments to support decision making (EFSA Journal 2010;8(6):1637) Website guidance document
- EFSA Guidance on submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA Journal 2011;9(2):2092) Website guidance document
- ECHA Guidance on the Application of the CLP Criteria Website guidance document
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