Active Substances
Active Substance 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 use of the benchmark dose approach in risk assessment (EFSA Journal 2017;15(1):4658) Website 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 on the assessment of new substances falling into the group of Straight Chain Lepidopteran Pheromones (SCLPs) included in Annex I of Council Directive 91/414/EEC, (SANCO 5272/2009) Website 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
- Guidance of EFSA on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers (SANTE/12278/2020) Website Noted by SCoPAFF 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
2.1: Melting point and boiling point
- OECD Test Guideline 102: Melting Point/ Melting Range Website test method
- OECD Test Guideline 103: Boiling point Website test method
2.2: Vapour pressure, volatility
- OECD Test Guideline 104: Vapour Pressure Website test method
2.4: Spectra (UV/VIS, IR, NMR, MS), molar extinction at relevant wavelengths, optical purity
2.5: Solubility in water
- OECD Test Guideline 105: Water Solubility Website test method
- Method A.6 Water solubility, Part A of Commission Regulation (EC) No 440/2008 Website test method
2.6: Solubility in organic solvents
- CIPAC Method MT 181: Solubility in organic solvents Website test method
- CIPAC Method MT 157: Water solubility Website test method
- OECD Test Guideline 105: Water Solubility Website test method
2.7: Partition coefficient n-octanol/water
- OECD Test Guideline 117: Partition Coefficient (n-octanol/water), HPLC method Website test method
- OECD Test Guideline 123: Partition coefficient (1-octanol/water): slow-stirring method Website test method
- OECD Test Guideline 107: Partition coefficient, shake-flask method Website test method
- Method A.23 Partition coefficient (1-octanol/water): Slow stirring method, Part A of Commission Regulation (EC) No 440/2008 Website test method
- Method A.24 Partition coefficient (n-octanol/water), High performance liquid chromatography (HPLC) method, Part A of Commission Regulation (EC) No 440/2008 Website test method
2.8: Dissociation in water
2.9: 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.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 N.5: test method for substances which in contact with water emit flammable gases, Part III of the UN RTDG Manual of Tests and Criteria 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
- Test L.2: sustained combustibility test, Part III of the UN RTDG Manual of Tests and Criteria Website test method
2.10: Flash point
- 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
2.11: Explosive properties
- Test methods according to Test series 1-3, Part I of the 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
2.12: Surface tension
- OECD Test Guideline 115: Surface tension of aqueous solutions Website test method
- Method A.5 Surface tension, (Annex of Commission Regulation (EC) No 440/2008) Website test method
2.13: Oxidising properties
- 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.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
- Transport of Dangerous Goods (UN RTDG) Manual of Tests and Criteria ST/SG/AC.10/11 Website test method
2.14: Other studies
- Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 (the Renewal Regulation) (SANCO/2012/11251) Website guidance document
- EPPO standard series PP1: Efficacy evaluation of plant protection products Website guidance document test method
3.5: Harmful organisms controlled and crops or products protected or treated
- EPPO Global Database on Crops and Pests (EPPO, 2017) Website guidance document test method
3.7: Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies
- EPPO standard PP1/213: Resistance risk analysis Website guidance document test method
4.1.1: Methods for the analysis of the active substance as manufactured
- 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
4.1.2: Methods for risk assessment
- 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
4.2: Methods for post-approval 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
- OECD Guidance for the Derivation of an Acute Reference Dose. Series on testing and assessment, No. 124 Website guidance document
- EU Working Document. Draft Guidance for the Setting and Application of Acceptable Operator Exposure Levels (AOEL’s) (SANCO/7531/2006) Website guidance document
- 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
5.1: Studies on absorption, distribution, metabolism and excretion in mammals
- OECD Guidance document on the characterisation, validation and reporting of Physiologically Based Kinetic (PBK) models for regulatory purposes. Series on Testing and Assessment, No. 331 Website guidance document
- OECD Test Guideline 417: Toxicokinetics Website test method
- Scientific Opinion of the Scientific Panel on Plant Protection Products and their Residues (PPR panel) on testing and interpretation of comparative in vitro metabolism studies (EFSA Journal 2021;19(12):6970) Website guidance document
- ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling Questions and Answers Guidance for Industry, 2018 Website guidance document
5.2.1: Oral
- 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
5.2.2: Dermal
5.2.3: Inhalation
- 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
5.2.4: 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
5.2.5: 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
5.2.6: 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
5.2.7: Phototoxicity
- ICH Safety Guidelines S10 Photosafety Evaluation of Pharmacetuticals Website guidance document
- OECD Test Guideline 101: UV-VIS Absorption Spectra Website test method
- OECD Test Guideline 432: In vitro 3T3 NRU Phototoxicity Test Website test method
- OECD Test No. 498: In vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity test method Website test method
- OECD Test No. 495: Ros (Reactive Oxygen Species) Assay for Photoreactivity Website test method
5.3: Short-term toxicity
- OECD Guidance Notes for Analysis and Evaluation of Repeat-Dose Toxicity Studies. Series on Testing and Assessment, No. 32 Website guidance document
- OECD Test Guideline 422: Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test Website test method
- ECHA. Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, 2012, ECHA-2010-G-19-EN Website test method
5.3.1: Oral 28-day study
5.3.2: Oral 90-day study
- OECD Test Guideline 408: Repeated dose 90-day oral toxicity study in rodents Website test method
- OECD Test Guideline 409: Repeated dose 90-day oral toxicity study in non-rodents Website test method
5.3.3: Other routes
- OECD Guidance Document on Histopathology for Inhalation Toxicity Studies, Supporting TG 412 (Subacute Inhalation Toxicity: 28-Day Study) and TG 413 (Subchronic Inhalation Toxicity: 90-Day Study). Series on Testing and Assessment, No. 125 Website guidance document
- OECD Test Guideline 410: Repeated dose dermal toxicity: 21/28-day study Website test method
- OECD Test Guideline 411: Subchronic dermal toxicity: 90-day study Website test method
- OECD Test Guideline 412: Subacute inhalation toxicity: 28-day study Website test method
- OECD Test Guideline 413: Subchronic inhalation toxicity: 90-day study Website test method
5.4: Genotoxicity testing
- EFSA Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment. (EFSA Journal 2011;9(9):2379) Website guidance document
- EFSA Scientific Opinion, Clarification of some aspects related to genotoxicity assessment (EFSA Journal 2017;15(12):5113) Website guidance document
- ICH Safety Guidelines S10 Photosafety Evaluation of Pharmacetuticals Website guidance document
- EFSA Guidance on aneugenicity assessment (PAFF-PPL-May22-Doc.A.07.02, EFSA Journal 2021;19(8):6770) Website Noted by SCoPAFF guidance document
5.4.1: In vitro studies
- OECD Test Guideline 471: Bacterial Reverse Mutation Test Website test method
- OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test Website test method
- OECD Test Guideline 473: In vitro Mammalian Chromosome Aberration Test Website test method
- OECD Test Guideline 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes Website test method
- OECD Test Guideline 490: In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene Website test method
5.4.2: In vivo studies in somatic cells
- OECD 470 Test Guideline on the Mammalian Erythrocyte Pig-a Gene Mutation Assay Website test method
- OECD Test Guideline 474: Mammalian Erythrocyte Micronucleus Test Website test method
- OECD Test Guideline 475: Mammalian Bone Marrow Chromosome Aberration Test Website test method
- OECD Test Guideline 486: Unscheduled DNA synthesis (UDS) - Test with mammalian liver cells in vivo Website test method
- OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays Website test method
- OECD test guideline 489: In Vivo Mammalian Alkaline Comet Assay Website test method
5.4.3: In vivo studies in germ cells
- OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays Website test method
- OECD Test Guideline 483: Mammalian Spermatogonial Chromosome Aberration Test Website test method
- OECD Test Guideline 478: Rodent Dominant Lethal Test Website test method
5.5: Long-term toxicity and carcinogenicity
- OECD Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting test methods 451, 452 and 453 Website guidance document
- OECD Test Guideline 453: Combined Chronic Toxicity/Carcinogenicity Studies Website test method
- OECD Test Guideline 451: Carcinogenicity Studies Website test method
- OECD Test Guideline 452: Chronic Toxicity Studies Website test method
5.6: Reproductive toxicity
- OECD Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting test methods 451, 452 and 453 Website guidance document
- OECD Guidance Document for Histologic Evaluation of Endocrine and Reproductive Tests in Rodents. Series on Testing and Assessment No. 106 Website guidance document
- OECD Guidance Document on Mammalian Reproductive Toxicity Testing and Assessment. Series on Testing and Assessment, No 43 Website guidance document
- OECD Series on Testing and Assessment No. 151: Guidance document supporting OECD test guideline 443 on the extended one-generation reproductive toxicity test Website test method
5.6.1: Generational studies
- OECD Test Guideline 416: Two-Generation Reproduction Toxicity Website test method
- OECD Test Guideline 443: Extended One-generation Reproductive Toxicity Website test method
5.6.2: Developmental toxicity studies
- North American Free Trade Agreement (NAFTA) Technical Working Group on Pesticides (TWG) Developmental Neurotoxicity Study Guidance Document Website guidance document
- OECD Developmental Neurotoxicity Study (OECD TG 426), Chapter.3.8 in Revised Guidance Document 150 on Standardised test methods for Evaluating Chemicals for Endocrine Disruption Website guidance document
- OECD Test Guideline 414: Prenatal developmental toxicity study Website test method
- OECD Test Guideline 426: Developmental neurotoxicity study Website test method
5.7: Neurotoxicity studies
- OECD Guidance Document for Neurotoxicity Testing. OECD Series on Testing and Assessment, No 20 Website guidance document
5.7.1: Neurotoxicity studies in rodents
5.7.2: Delayed polyneuropathy studies
- OECD Test Guideline 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure Website test method
- OECD Test Guideline 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study Website test method
5.8.1: Toxicity studies of metabolites
- EU Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council Directive 91/414/EEC (SANCO/221/2000) Website guidance document
5.8.2: Supplementary studies on the active substance
- ICH Safety Guidelines S8 Immunotoxicity studies for Human Pharmaceuticals Website test method
- Health Effects Test Guidelines: OPPTS 870.7800 Immunotoxicity [EPA 712–C–98–351] Website test method
- OECD Guidance for conducting a single exposure toxicity study. IN: OECD (2010) Guidance for the Derivation of an Acute Reference Dose”. Series on testing and assessment, No. 124 Website guidance document
5.8.3: Endocrine disrupting properties
- Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 (C/2018/6040, EFSA Journal 2018;16(6):5311) Website guidance document
- OECD Revised Guidance Document No. 150 on Standardised test methods for Evaluating Chemicals for Endocrine Disruption. Website guidance document
- Test guidelines are listed in OECD Revised Guidance Document No. 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption. Some of these test guidelines (OECD 407,408,409,414,443,416,426, 451-3) are already requested under 5.3.1; 5.3.2; 5.6.1;5.6.2;5.5 Website test method
- OECD Guidance Document on Overview of Residue Chemistry Studies . Series on Testing and Assessment, No. 64 and Series on Pesticides, No. 32 Website guidance document
6.1: Storage stability of residues
6.2.1: Plants
- OECD Test Guideline 501: Metabolism in crops Website test method
6.2.2: Poultry
6.2.3: Lactating ruminants
6.2.4: Pigs
6.3: Magnitude of residue trials in plants
- OECD Guidance Document on Crop Field Trials. Series on Testing and Assessment, No. 164 and Series on Pesticides No. 66 Website guidance document
- Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolations of residue data on products from plant and animal origin (SANTE/2019/12752) Website guidance document
- OECD Test Guideline 509: Crop field trials Website test method
6.4: Feeding studies
- EFSA Estimation of animal intakes and HR, STMR and MRL calculations for products of animal origin Website guidance document
- EFSA Spreadsheet for HR, STMR and MRL calculations for products of animal origin; EU Animal burden calculator - animals Website guidance document
- OECD Guidance Document on Residues in Livestock. Series on Pesticides, No. 73 Website guidance document
6.4.1: Poultry
6.4.2: Ruminants
6.4.3: Pigs
6.5.1: Nature of the residue
- OECD Test Guideline 507: Nature of the pesticide residues in processed commodities – High temperature hydrolysis. Website test method
6.5.2: Distribution of the residue in inedible peel and pulp
- OECD Test Guideline 509: Crop field trials Website test method
- OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. Website test method
6.5.3: Magnitude of residues in processed commodities
- OECD Guidance document on magnitude of pesticide residues in processed commodities. Environment, Health and Safety Publications. Series on Testing and Assessment No. 96. Website guidance document
- OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. Website test method
6.6: Residues in rotational crops
- OECD Guidance document on residues in rotational crops. Series on Pesticides, No. 97. and Series on Testing and Assessment, No. 279. Website guidance document
6.6.1: Metabolism in rotational crops
6.6.2: Magnitude of residues in rotational crops
- OECD Test Guideline 509: Crop field trials Website test method
- OECD Test Guideline 504: Residues in rotational crops (limited field studies) Website test method
6.7.1: Proposed residue definitions
- OECD Guidance Document on the Definition of Residues. Environment, Health and Safety Publications. Series on Testing and Assessment, No. 63 and Series on Pesticides, No. 31 Website guidance document
6.7.2: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed
- OECD MRL calculator : User guide Website guidance document
- Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolations of residue data on products from plant and animal origin (SANTE/2019/12752) Website guidance document
6.7.3: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed for imported products (import tolerance)
- OECD MRL calculator : User guide Website guidance document
- Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolations of residue data on products from plant and animal origin (SANTE/2019/12752) Website guidance document
6.8: Proposed safety intervals
- EU guidance document "Calculation of Maximum Residue Levels and Safety Intervals e.g. Pre-harvest Intervals" (SANCO 7039/VI/95) Website guidance document
6.9: Estimation of the potential and actual exposure through diet and other sources
- EU Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council Directive 91/414/EEC (SANCO/221/2000) Website guidance document
- WHO Guidelines for drinking water quality Website guidance document
- EFSA calculation model Pesticide Residue Intake Model "PRIMo" Website guidance document
6.10.1: Residue level in pollen and bee products
7.1: Fate and behaviour in soil
- 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
7.1.1.1: Aerobic degradation
7.1.1.2: Anaerobic degradation
7.1.1.3: Soil photolysis
- SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides Website guidance document
- 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
- US EPA Test Guideline OPPTS 835.2410 Photodegradation on Soil. EPA 712-C-08-015, October 2008 Website test method
7.1.2: Rate of degradation 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
- DG SANCO Working Document on "Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides" Website 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
7.1.2.1: Laboratory studies
7.1.2.2: Field studies
- US EPA OCSPP 835.6100: Terrestrial field dissipation Website test method
- 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
7.1.3: Adsorption and desorption in soil
- 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
7.1.3.1: Adsorption and desorption
- European Commission. Scientific Committee on plants SCP/KOC/002-Final. Opinion of the Scientific Committee on Plants on methods for the determination of the organic carbon adsorption coefficient (Koc) for a plant protection product active substance in the context of Council Directive 91/414/EEC (18 July 2002)[3] Website guidance document
- 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
7.1.3.2: Aged sorption
- Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments EC Document Reference (SANTE/12586/2020) Website guidance document
7.1.4.1: Column leaching studies
7.1.4.2: Lysimeter studies
- 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
- OECD Guidance Document for the Performance Of Out-door Monolith Lysimeter Studies. Series on Testing and Assessment, No. 22 Website test method
7.1.4.3: Field leaching studies
- 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
7.2.1.1: Hydrolytic degradation
7.2.1.2: Direct photochemical degradation
- OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis Website test method
7.2.2: Route and rate of biological degradation in aquatic systems
- DG SANCO Working Document on "Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides" Website guidance document
7.2.2.1: ‘Ready biodegradability’
- OECD Guideline Test 301: Ready Biodegradability (301 A - F) Website test method
- OECD Test Guideline 310: Ready Biodegradability - CO2 in sealed vessels (Headspace Test) Website test method
7.2.2.2: Aerobic mineralisation in surface water
- OECD Test Guideline 309: Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test Website test method
7.2.2.3: Water/sediment study
- 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 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems Website test method
7.2.2.4: Irradiated water/sediment study
- OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems Website test method
7.3: 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
8.1: Effects on birds and other terrestrial vertebrates
- EFSA Risk assessment for birds and mammals (EFSA Journal 2009; 7(12):1438) Website guidance document
8.1.1.1: 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
8.1.1.2: Short-term dietary toxicity to birds
- OECD Test Guideline 205: Avian Dietary Toxicity Test Website test method
- US EPA OCSPP 850.2200: Avian dietary toxicity test Website test method
8.1.1.3: Sub-chronic and reproductive toxicity to birds
- OECD Test Guideline 206: Avian Reproduction Test Website test method
- US EPA OCSPP 850.2300: Avian Reproduction Test Website test method
8.1.4: Effects on terrestrial vertebrate wildlife (birds, mammals, 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
8.1.5: Endocrine disrupting properties
- Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 (C/2018/6040, EFSA Journal 2018;16(6):5311) Website guidance document
- OECD Revised Guidance Document No. 150 on Standardised test methods for Evaluating Chemicals for Endocrine Disruption. Website guidance document
- Test guidelines are listed in OECD Revised Guidance Document No. 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption. test method
8.2: Effects on aquatic organisms
- 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
8.2.1: Acute toxicity to fish
- 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 Short guidance on the threshold approach for acute fish toxicity. Series on Testing and Aassessment, No 126 Website guidance document
- OECD Test Guideline 203: Fish, Acute Toxicity Test Website test method
8.2.2: Long-term and chronic toxicity to fish
- 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
8.2.2.1: Fish early life stage toxicity test
- OECD Test Guideline 210: Fish, Early-life Stage Toxicity Test Website test method
- OECD Test No. 234: Fish Sexual Development Test Website test method
8.2.2.2: Fish full life cycle test
8.2.2.3: Bioconcentration in fish
8.2.3: Endocrine disrupting properties
- Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 (C/2018/6040, EFSA Journal 2018;16(6):5311) Website guidance document
- OECD Revised Guidance Document No. 150 on Standardised test methods for Evaluating Chemicals for Endocrine Disruption. Website guidance document
- Test guidelines are listed in OECD Revised Guidance Document No. 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption. test method
8.2.4: Acute toxicity to aquatic invertebrates
- 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
8.2.4.1: Acute toxicity to Daphnia magna
8.2.4.2: Acute toxicity to an additional aquatic invertebrate species
- OECD Test Guideline 235: Chironomus sp., Acute Immobilisation Test Website test method
- US EPA OCSPP 850.1035 Mysid Acute Toxicity Test Website test method
- US EPA 850.1025 (Oyster acute toxicity test) Website test method
8.2.5: Long-term and chronic toxicity to aquatic invertebrates
- 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
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
- US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test Website test method
- OECD Test Guideline 242: Potamopyrgus antipodarum Reproduction Test Website test method
- OECD Test Guideline 243: Lymnaea stagnalis Reproduction Test Website test method
8.2.5.3: Development and emergence in Chironomus riparius
8.2.5.4: Sediment dwelling organisms
- OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment Website test method
- OECD Test No. 233 (2010) Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment Website test method
- OECD Test Guideline 225: Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment Website test method
8.2.6: Effects on algal growth
- 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
8.2.6.1: Effects on growth of green algae
8.2.6.2: Effects on growth of an additional algal species
8.2.7: Effects on aquatic macrophytes
- 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 Test No. 221 Lemna sp. Growth Inhibition Test Website test method
- ASTM E1913-04: Standard Guide for Conducting Static, Axenic, 14-Day Phytotoxicity Tests in Test Tubes with the Submersed Aquatic Macrophyte, Myriophyllum sibiricum Komarov Website test method
- Development of a proposed test method for the rooted aquatic macrophyte Myriophyllum sp. In: Maltby L, Arnold D, Arts G, et al (2010). Aquatic Macrophyte Risk Assessment for pesticides (AMRAP). SETAC Press & CRC Press, Taylor & -Francis Group, Boca Raton, London, New York, p. 46-56. Website test method
- OECD Test No. 238: Sediment-Free Myriophyllum Spicatum Toxicity Test Website test method
- OECD Test No. 239: Water-Sediment Myriophyllum Spicatum Toxicity Test Website test method
8.2.8: Further testing 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
8.3: Effect on arthropods
- EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) Website guidance document
8.3.1.1.1: 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
8.3.1.1.2: 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
8.3.1.2: Chronic toxicity to bees
- OECD Test Guideline 245 Honey Bee (Apis mellifera l.), Chronic Oral Toxicity Test Website test method
8.3.1.3: Effects on honeybee development and other honeybee 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
8.3.1.4: 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
8.3.2: 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
8.3.2.1: Effects on Aphidius rhopalosiphi
- M.P. Candolfi, S. Blümel, R. Forster et al. (2000): Guidelines to evaluate side-effects of plant protection products to non-target arthropods. IOBC, BART and EPPO Joint Initiative. ISBN: 92-9067 129-7. Website test method
8.3.2.2: Effects on Typhlodromus pyri
- M.P. Candolfi, S. Blümel, R. Forster et al. (2000): Guidelines to evaluate side-effects of plant protection products to non-target arthropods. IOBC, BART and EPPO Joint Initiative. ISBN: 92-9067 129-7. Website test method
8.4: Effects on non-target soil meso- and macrofauna
- EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) Website guidance document
- De Jong et al (2006): Guidance for summarizing earthworm field studies. RIVM report No 601506006/2006 Website guidance document
8.4.1: Earthworm — sub-lethal effects
- OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) Website test method
- ISO 23611-1:2018: Soil quality - Sampling of soil invertebrates - Part 1: Hand-sorting and extraction of earthworms Website test method
- 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
8.4.2: 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
8.4.2.1: 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
8.5: 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
8.6: Effects on terrestrial non-target higher plants
- EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) Website guidance document
8.6.2: 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
8.7: Effects on other terrestrial organisms (flora and fauna)
- EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) Website guidance document
8.8: Effects on biological methods for sewage treatment
- 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
Active Substance Part B (micro-organisms)
- 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
- 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
- OECD Guidance Document on Good In Vitro Method Practices (GIVIMP) Website guidance document
- EU Guidance document on the assessment of new isolates of baculovirus species already included in Annex I of Council Directive 91/414/EEC (SANCO/0253/2008) Website guidance document
- EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) Website guidance document
- OECD Guidance Document for the Regulatory Framework for the Microorganism Group: Bacteriophages Series on Pesticides No. 108 Website guidance document
- EU Guidance document for the assessment of the equivalence of technical grade active ingredients for identical microbial strains or isolates approved under Regulation (EC) No. 1107/2009 (SANCO/12823/2012) Website guidance document
1.4.2.2: Identity and content of relevant contaminating micro-organisms
2.7: Genetic stability and factors affecting it
- EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) Website guidance document
2.8: Information on metabolites of concern
- EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) Website guidance document
- EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) Website guidance document
2.9: Presence of transferable antimicrobial resistance genes
3.1: Function and target organism
- EPPO Standard PP1/248: Harmonized system for classification and coding of the uses of plant protection products Website guidance document test method
3.3: Crops or products protected or treated
- EPPO Global Database on Crops and Pests (EPPO, 2017) Website guidance document test method
- EPPO Standard PP1/248: Harmonized system for classification and coding of the uses of plant protection products Website guidance document test method
3.4: Information on possible development of resistance in the target organism(s)
- EPPO standard PP1/213: Resistance risk analysis Website guidance document test method
3.5: Literature data
4.1: Methods for the analysis of the MPCA as manufactured
- 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
- OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 Website guidance document
4.2: Methods to determine the density of the micro-organism and quantify residues
5.1.3: Information on sensitisation and allergenicity
5.3.1.1: Oral infectivity and pathogenicity
5.3.1.2: Intratracheal/ intranasal infectivity and pathogenicity
5.3.1.3: Intravenous, intraperitoneal or subcutaneous single exposure
- US EPA OPPTS 885.3200 Microbial pesticide test methods. Acute injection toxicity/pathogenicity Website test method
5.3.2: Cell culture study
- US EPA OPPTS 885.3500 Cell culture Website test method
5.4: Specific infectivity and pathogenicity studies on the micro-organism
- US EPA OPPTS 885.3600 Subchronic Toxicity/Pathogenicity Website test method
- US EPA OPPTS 885.3650 Reproductive/fertility effects Website test method
5.5: Information and toxicity studies on metabolites
- European Commission draft guidance document Guidance for the setting of an acute reference dose (ARfD) (7199/VI/99) Website guidance document
- OECD Guidance for the Derivation of an Acute Reference Dose. Series on testing and assessment, No. 124 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
6.1: Estimation of consumer exposure to residues
7.1.1: Predicted environmental density of the micro-organism
- EFSA Guidance document on clustering and ranking of emissions of active substances of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments, Section 2 (EFSA Journal 2014;12(3):3615) Website Noted by SCoPAFF guidance document
7.1.1.1: Soil
- EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents, section 3.1.2 (SANCO/12117/2012) Website guidance document
7.1.1.2: Water
- EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents, section 3.1.2 (SANCO/12117/2012) Website guidance document
7.2.1: Predicted environmental concentration
- 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
- 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
- EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents, section 3.1.2 (SANCO/12117/2012) Website guidance document
- Environment and Climate Change Canada (2016), guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS1/RM/44) Website guidance document
- The relevant methods indicated under this Section may need to be adapted on a case-by-case basis. Hence the applicability of the methods selected, or adaptations of them, shall be justified in light of the biological and ecological characteristcs of the active substance to be assessed and it may be discussed in pre-submission meetings. Website
- US EPA 885.4000 (1996) Background for non-target organism testing of microbial pest control agents Website guidance document
8.1: Effects on terrestrial vertebrates
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS1/RM/44), 14.1 Birds Website guidance document test method
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 14.2 Small Mammals Website guidance document test method
8.2: Effects on aquatic organisms
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 11.1 Freshwater Fish Website guidance document test method
8.2.1: Effects on fish
- OECD Test Guideline 203: Fish, Acute Toxicity Test Website test method
- OECD Test Guideline 210: Fish, Early-life Stage Toxicity Test Website test method
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 11.1 Freshwater Fish Website guidance document test method
- US EPA OCSPP 885.4200 freshwater fish Tier I Website test method
8.2.2: Effects on aquatic invertebrates
- OECD Test No. 233 (2010) Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment Website test method
- US EPA OCSPP 885.4240 Freshwater invertebrate Tier I Website test method
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 10.1 Freshwater Invertebrates Website guidance document test method
8.2.3: Effects on algae
- OECD Test No. 201 Freshwater Alga and Cyanobacteria, Growth Inhibition Test Website test method
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 9.1 Freshwater plants Website guidance document test method
- US EPA OCSPP 885.4300 Non target plant studies Tier I Website test method
8.2.4: Effects on aquatic macrophytes
- OECD Test No. 221 Lemna sp. Growth Inhibition Test Website test method
- OECD Test No. 238: Sediment-Free Myriophyllum Spicatum Toxicity Test Website test method
- OECD Test No. 239: Water-Sediment Myriophyllum Spicatum Toxicity Test Website test method
8.3: Effects on bees
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.1 Honey bees Website guidance document test method
- OECD Guidance Document on the Honey Bee (Apis mellifera L.) Brood test Under Semi-field Conditions. Series on Testing and Assessment, No. 75 Website test method
- OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test Website test method
- OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test Website test method
- OECD Test Guideline 245 Honey Bee (Apis mellifera l.), Chronic Oral Toxicity Test 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
- EPPO Bulletin (2010) 40 Side-Effects On Honeybees Website test method
- OECD Test No. 247 Bumblebee, Acute Oral Toxicity Test Website test method
- US EPA OCSPP 885.4380 Honey bee Tier I Website test method
- EPPO Bulletin (2019) 49 Oomen Bee Brood Feeding Test Website test method
8.4: Effects on non-target arthropods other than bees
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.1 Tests for Plant-Dwelling Invertebrates Website guidance document test method
- US EPA OCSPP 885.4340 Non-target Insect Tier I Website test method
8.5: Effects on non-target meso- and macro-organisms in soil
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.2 Springtails Website guidance document test method
- OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) Website test method
- 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
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.2 Earthworms Website guidance document test method
8.6: Effects on non-target terrestrial 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
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 12.2 Terrestrial plants Website guidance document test method
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
PPP Part B (micro-organisms)
- ECHA Guidance on the Application of the CLP Criteria Website 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
- 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 Guidance Document on Good In Vitro Method Practices (GIVIMP) Website guidance document
- EU Guidance document for the assessment of the equivalence of technical grade active ingredients for identical microbial strains or isolates approved under Regulation (EC) No. 1107/2009 (SANCO/12823/2012) Website guidance document
1.4: Detailed quantitative and qualitative information on the composition of the preparation
- 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 Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 Website guidance document
2.6: Storage stability and shelf life
- OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 Website guidance document
- OECD Guidance document on storage stability of microbial pest control products. Series on Pesticides No. 85 (ENV/JM/MONO(2016)54) Website guidance document
2.6.2: Effects of temperature and packaging
- CIPAC Method MT 46: Accelerated storage procedure Website test method
- CIPAC MT 39 Stability of liquid formulations at 0˚C Website test method
2.7: Technical characteristics of the plant protection product
2.7.1: Wettability
- CIPAC Method MT 53: Wettability Website test method
2.7.2: Persistent foaming
- CIPAC Method MT 47 Persistent foaming Website test method
2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability
- CIPAC MT 41 Dilution stability of herbicide aqueous solutions Website test method
- CIPAC MT 179 Dissolution degree and solution stability Website test method
- CIPAC Method MT 196: Solution Properties of Water Soluble Tablets Website test method
- 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
2.7.4: Dry sieve test and wet sieve test
- 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
2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)
- 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
- CIPAC Method MT 171: Dustiness of granular products Website test method
- CIPAC Method MT 178: Attrition resistance of granules Website test method
- CIPAC Method MT 193: Attrition of tablets Website test method
- CIPAC Method MT 197: Disintegration of tablets Website test method
2.7.6: Emulsifiability, re-emulsifiability and emulsion stability
2.7.7: Flowability, pourability (rinsability) and dustability
- CIPAC Method MT 171: Dustiness of granular products Website test method
- 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
2.8: Physical and chemical compatibility with other plant protection 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
2.9: 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
- EPPO Global Database on Crops and Pests (EPPO, 2017) Website guidance document test method
3.3: Function, target organisms and plants or plants products to be protected and possible risk mitigation measures
- EPPO Standard PP1/248: Harmonized system for classification and coding of the uses of plant protection products Website guidance document test method
3.4: Application rate
- EPPO Standard PP1/239: Dose expression of plant protection products Website guidance document test method
4.1: Procedures for cleaning and decontaminating of application equipment
- EPPO Standard PP1/292: Cleaning pesticide application equipment (PAE) – efficacy aspects Website guidance document test method
5.1: Methods for the analysis of the preparation
- 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
- OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 Website guidance document
5.2: Methods to determine and quantify residues
- 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
- General EPPO standard series PP1 (Efficacy evaluation of plant protection products), in particular: EPPO PP1/276 Principles of efficacy evaluation for microbial plant protection products, EPPO PP1/296 principles of efficacy evaluation for low-risk plant protection products, and, EPPO PP1/319 General principles for efficacy evaluation of plant protection products with a mode of action as plant defence inducers. Website guidance document
- Specific Standards of the EPPO standard series PP1 Website test method
6.6.1: Impact on succeeding crops
- EPPO PP1/207 Effects on succeeding crops Website guidance document
- OECD Test No. 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Website guidance document test method
6.6.2: Impact on other plants, including adjacent crops
- EPPO PP1/256 Effects on adjacent crops Website guidance document
- 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
7.2: Assessment of potential toxicity of the plant protection product
- 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
7.3: Acute toxicity
- OECD Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests. Series on Testing & Assessment, No. 237 Website guidance document
7.3.1: Acute oral toxicity
- 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
7.3.2: Acute dermal toxicity
7.3.3: Acute 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
7.3.4: 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
7.3.5: Eye irritation
- 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 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
7.3.6: 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
- OECD Guideline No. 497: Defined Approaches on Skin Sensitisation Website test method
- OECD Test Guideline 442D: In Vitro Skin Sensitisation Website test method
- OECD Test Guideline 442E: In Vitro Skin Sensitisation: In Vitro Skin Sensitisation Assays Addressing the Key Event on Activation of Dendritic Cells on the Adverse Outcome Pathway for Skin Sensitisation Website test method
- OECD Test Guideline 442C: In Chemico Skin Sensitisation Website test method
7.5: Data on exposure
- EU Guidance on dermal adsorption (SANTE/2018/10591) Website Noted by SCoPAFF guidance document
- EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) Website guidance document
- EFSA Guidance on dermal absorption (EFSA Journal 2017;15(6):4873) Website Noted by SCoPAFF guidance document
- FAO Operator exposure models and local risk assessment Website guidance document
- OECD Test Guideline 428: Skin absorption: in vitro method Website test method
- OECD Test Guideline 427: Skin absorption: in vivo method Website test method
- 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
- EFSA Guidance on the establishment of the residue definition for dietary risk assessment (EFSA Journal 2016;14(12):4549) Website guidance document
- EFSA Reporting data on pesticide residues in food and feed according to Regulation (EC) No 396/2005 (2018 data collection) (EFSA Journal 2019;17(4):5655) Website guidance document
- EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) Website guidance document
- EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) Website guidance document
- Test methods indicated either in the Commission's Communication for the implementation of Part B of the Annex to Commission Regulation (EU) No 283/2013, or in the Commission's Communication for the implementation of Part A of the Annex to Commission Regulation (EU) No 284/2013 may be used as a basis and re-adapted. The applicability of the methods selected, or adaptations of them, shall be justified in light of the specificities of the case at stake and it may be discussed in pre-submission meetings.
- OECD Guidance to the environmental safety evaluation of microbial biocontrol agents, Series on Pesticides No. 67 (ENV/JM/MONO(2012)1) Website guidance document
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