Active Substances
Active Substance Part A (chemicals)
- 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 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
- 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
- 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 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
- ECHA. Read-Across Assessment Framework (RAAF), ECHA-17-R-01-EN 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
- 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
- OECD Test Guideline 105: Water Solubility Website test method
- CIPAC Method MT 181: Solubility in organic solvents Website test method
- CIPAC Method MT 157: Water solubility Website test method
2.7: Partition coefficient n-octanol/water
- OECD Test Guideline 107: Partition coefficient, shake-flask method Website test method
- 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
- 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
- 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 O.3: Gravimetric test for oxidising solids, Part III of UN RTDG Manual of Tests and Criteria 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
- 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
- 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
4.2: Methods for post-approval control and monitoring purposes
- 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
- 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 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
- 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
- OECD Test Guideline 417: Toxicokinetics Website test method
- 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 Guidance Document for the Derivation of an Acute Reference Concentration (Arfc). Series on Testing and Assessment, No. 153 Website guidance document
- 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 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 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
- 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
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 443: Extended One-generation Reproductive Toxicity Website test method
- OECD Test Guideline 416: Two-Generation Reproduction 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
- Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Regulation (EC) No 1107/2009 (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
- OECD Guidance Document on Residues in Livestock. Series on Pesticides, No. 73 Website guidance document
- 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
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
- 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 MRL calculator : User guide 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)
- 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 MRL calculator : User guide 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
- Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Regulation (EC) No 1107/2009 (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 18400-102:2017 Website test method
- ISO 18400-104:2018 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
- Guidance document on Risk assessment for Birds and Mammals (PAFF-PPL-3 October 2024-Doc.A.07.01 rev. 1.1) Website Noted by SCoPAFF 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
- OECD Short guidance on the threshold approach for acute fish toxicity. Series on Testing and Aassessment, No 126 Website guidance document
- 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 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 Guidance Document on Honey Bee Larval Toxicity Test following Repeated Exposure. Series on Testing and Assessment, No. 239 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
- 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 Guideline 232: Collembolan Reproduction Test in Soil Website test method
- OECD Test No. 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) 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
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