| Document | Title | Listed * | Endorsed * | Category | Author | Type | Website | Noted by SCoPAFF | Template | Sections | Sections | Communication notes | Public comments | Further information |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 321 | 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 | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_efficacy_ppp.pdf | PPP Part A (chemicals)6: Efficacy dataPPP Part B (micro-organisms)6: Efficacy data |
6: Efficacy data (284-A), 6: Efficacy data (284-B) | ||||||
| 324 | EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_ecotox_terrestrial.pdf | Active Substance Part A (chemicals)8.3: Effect on arthropods8.4: Effects on non-target soil meso- and macrofauna 8.5: Effects on soil nitrogen transformation 8.6: Effects on terrestrial non-target higher plants 8.7: Effects on other terrestrial organisms (flora and fauna) 8.8: Effects on biological methods for sewage treatment PPP Part A (chemicals)10.3: Effects on arthropods10.4: Effects on non-target soil meso- and macrofauna 10.5: Effects on soil nitrogen transformation 10.6: Effects on terrestrial non-target higher plants 10.7: Effects on other terrestrial organisms (flora and fauna) |
8.3: Effect on arthropods (283-A), 8.4: Effects on non-target soil meso- and macrofauna (283-A), 8.5: Effects on soil nitrogen transformation (283-A), 8.6: Effects on terrestrial non-target higher plants (283-A), 8.7: Effects on other terrestrial organisms (flora and fauna) (283-A), 8.8: Effects on biological methods for sewage treatment (283-A), 10.3: Effects on arthropods (284-A), 10.4: Effects on non-target soil meso- and macrofauna (284-A), 10.5: Effects on soil nitrogen transformation (284-A), 10.6: Effects on terrestrial non-target higher plants (284-A), 10.7: Effects on other terrestrial organisms (flora and fauna) (284-A) | ||||||
| 325 | Pesticides in Air: Considerations for Exposure Assessment”. Report of the FOCUS Working Group on Pesticides in Air (SANCO/10553/2006) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2007.513 | Active Substance Part A (chemicals)7.3: Fate and behaviour in airPPP Part A (chemicals)9.2.5: Estimation of concentrations in surface water and sediment9.3: Fate and behaviour in air |
7.3: Fate and behaviour in air (283-A), 9.2.5: Estimation of concentrations in surface water and sediment (284-A), 9.3: Fate and behaviour in air (284-A) | ||||||
| 327 | EU Guidance Document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No. 1107/2009 (SANCO/10597/2003) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_subst-tech_201207.pdf | Active Substance Part A (chemicals)1: Identity of the active substancePPP Part A (chemicals)1: Identity of the plant protection product |
1: Identity of the active substance (283-A), 1: Identity of the plant protection product (284-A) | ||||||
| 328 | Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE/2017/10632) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2023-05/pesticides_mrl_guidelines_wrkdoc_2017-10632.pdf | Active Substance Part A (chemicals)4.1.2: Methods for risk assessment4.2: Methods for post-approval control and monitoring purposes PPP Part A (chemicals)5.1.2: Methods for the determination of residues5.2: Methods for post-authorisation control and monitoring purposes |
4.1.2: Methods for risk assessment (283-A), 4.2: Methods for post-approval control and monitoring purposes (283-A), 5.1.2: Methods for the determination of residues (284-A), 5.2: Methods for post-authorisation control and monitoring purposes (284-A) | ||||||
| 331 | 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) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2019-03/pesticides_ppp_app-proc_guide_pai_11251.pdf | Active Substance Part A (chemicals)3: Further information on the active substance |
3: Further information on the active substance (283-A) | ||||||
| 332 | Guidance Document on botanical active substances used in plant protection products (SANCO/11470/2012) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_doss_botanicals-rev-8.pdf | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 333 | EU guidance document “Technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels in honey” (SANTE/11956/2016 ) | Yes | Yes | guidance document,
test method |
SANTE | https://food.ec.europa.eu/system/files/2018-10/pesticides_mrl_guidelines_honey.pdf | Active Substance Part A (chemicals)6.10.1: Residue level in pollen and bee products |
6.10.1: Residue level in pollen and bee products (283-A) | ||||||
| 334 | EFSA Panel on Plant Protection Products; Guidance for evaluating laboratory and field dissipation studies to obtain DegT 50 values of plant protection products in soil. EFSA Journal 2010;8(12):1936. | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/1936 | ||||||||
| 335 | 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)) | Yes | Yes | guidance document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/3662 | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_fate_efsa_degt50.pdf | Active Substance Part A (chemicals)7.1.2: Rate of degradation in soil7.2.2.3: Water/sediment study Active Substance Part B (micro-organisms)7.2.1: Predicted environmental concentrationPPP Part A (chemicals)9.1: Fate and behaviour in soil9.2: Fate and behaviour in water and sediment |
7.1.2: Rate of degradation in soil (283-A), 7.2.2.3: Water/sediment study (283-A), 7.2.1: Predicted environmental concentration (283-B), 9.1: Fate and behaviour in soil (284-A), 9.2: Fate and behaviour in water and sediment (284-A) | The generic FOCUS guidance documents that are based on the relevant, more specific guidance documents and regularly updated are listed. | ||||
| 338 | Guidance document on semiochemical active substances and plant protection products (SANTE/12815/2014) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/document/download/ae787d28-356b-4e42-8c15-89ed8c91faf2_en?filename=pesticides_ppp_app-proc_guide_doss_semiochemicals_202401.pdf | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 339 | Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2023-04/pesticides_mrl_guidelines_2020-12830.pdf | Active Substance Part A (chemicals)4.1.2: Methods for risk assessment4.2: Methods for post-approval control and monitoring purposes Active Substance Part B (micro-organisms)4.2: Methods to determine the density of the micro-organism and quantify residuesPPP Part A (chemicals)5.1.2: Methods for the determination of residues5.2: Methods for post-authorisation control and monitoring purposes PPP Part B (micro-organisms)5.2: Methods to determine and quantify residues |
4.1.2: Methods for risk assessment (283-A), 4.2: Methods for post-approval control and monitoring purposes (283-A), 4.2: Methods to determine the density of the micro-organism and quantify residues (283-B), 5.1.2: Methods for the determination of residues (284-A), 5.2: Methods for post-authorisation control and monitoring purposes (284-A), 5.2: Methods to determine and quantify residues (284-B) | Part B of Communication 283/2013: if relevant for residues of metabolites of concern. | |||||
| 340 | 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) | Yes | Yes | guidance document | SANTE | https://esdac.jrc.ec.europa.eu/public_path/projects_data/focus/gw/NewDocs/focusGWReportOct2014.pdf | Active Substance Part A (chemicals)7.1.4.2: Lysimeter studies7.1.4.3: Field leaching studies PPP Part A (chemicals)9.1.2: Mobility in the soil9.1.3: Estimation of concentrations in soil |
7.1.4.2: Lysimeter studies (283-A), 7.1.4.3: Field leaching studies (283-A), 9.1.2: Mobility in the soil (284-A), 9.1.3: Estimation of concentrations in soil (284-A) | ||||||
| 341 | 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) | Yes | Yes | guidance document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/3290 | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_ecotox_aquatic.pdf | Active Substance Part A (chemicals)8.2.1: Acute toxicity to fish8.2.2: Long-term and chronic toxicity to fish 8.2.4: Acute toxicity to aquatic invertebrates 8.2.5: Long-term and chronic toxicity to aquatic invertebrates 8.2.6: Effects on algal growth 8.2.7: Effects on aquatic macrophytes 8.2.8: Further testing on aquatic organisms PPP Part A (chemicals)10.2: Effects on aquatic organisms |
8.2.1: Acute toxicity to fish (283-A), 8.2.2: Long-term and chronic toxicity to fish (283-A), 8.2.4: Acute toxicity to aquatic invertebrates (283-A), 8.2.5: Long-term and chronic toxicity to aquatic invertebrates (283-A), 8.2.6: Effects on algal growth (283-A), 8.2.7: Effects on aquatic macrophytes (283-A), 8.2.8: Further testing on aquatic organisms (283-A), 10.2: Effects on aquatic organisms (284-A) | |||||
| 373 | European Commission draft guidance document Guidance for the setting of an acute reference dose (ARfD) (7199/VI/99) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_tox_acute-ref-dose.pdf | Active Substance Part B (micro-organisms)5.5: Information and toxicity studies on metabolites |
5.5: Information and toxicity studies on metabolites (283-B) | ||||||
| 376 | US EPA OCSPP 835.6100: Terrestrial field dissipation | Yes | N/A | test method | EPA | https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0152-0040 | Active Substance Part A (chemicals)7.1.2.2: Field studies |
7.1.2.2: Field studies (283-A) | ||||||
| 378 | ECHA Guidance on the Application of the CLP Criteria | Yes | Yes | guidance document | ECHA | https://echa.europa.eu/documents/10162/2324906/clp_en.pdf/58b5dc6d-ac2a-4910-9702-e9e1f5051cc5 | Active Substance Part A (chemicals)0: General Guidance2: Physical and chemical properties of the active substance 10: Classification and labelling PPP Part A (chemicals)0: General Guidance2: Physical, chemical and technical properties of the plant protection product 12: Classification and labelling PPP Part B (micro-organisms)0: General Guidance |
0: General Guidance (283-A), 2: Physical and chemical properties of the active substance (283-A), 10: Classification and labelling (283-A), 0: General Guidance (284-A), 2: Physical, chemical and technical properties of the plant protection product (284-A), 12: Classification and labelling (284-A), 0: General Guidance (284-B) | ||||||
| 379 |
Alix et al, 2012. ESCORT 3 – linking non-target arthropod testing and risk assessment with protection goals. CRC SETAC Press, 1–151.
|
No | N/A | supporting document | SETAC | |||||||||
| 380 | 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] | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2020-12/sci-com_scp_out95_ppp_en.pdf | Active Substance Part A (chemicals)7.1.3.1: Adsorption and desorption |
7.1.3.1: Adsorption and desorption (283-A) | ||||||
| 382 | FAO Guidelines for the packaging and storage of pesticides (FAO, Rome, 1985) | Yes | Yes | guidance document | FAO | https://www.fao.org/pest-and-pesticide-management/pesticide-risk-reduction/code-conduct/packaging-labelling-and-advertising/en/ | PPP Part A (chemicals)4: Further information on the plant protection product |
4: Further information on the plant protection product (284-A) | ||||||
| 383 | DG SANCO Working Document on "Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides" | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_fate_evidence_identify-pop-pbt-vpvb-props.pdf | Active Substance Part A (chemicals)7.1.2: Rate of degradation in soil7.2.2: Route and rate of biological degradation in aquatic systems PPP Part A (chemicals)9.1.1.1: Laboratory studies9.2.1: Aerobic mineralisation in surface water 9.2.2: Water/sediment study |
7.1.2: Rate of degradation in soil (283-A), 7.2.2: Route and rate of biological degradation in aquatic systems (283-A), 9.1.1.1: Laboratory studies (284-A), 9.2.1: Aerobic mineralisation in surface water (284-A), 9.2.2: Water/sediment study (284-A) | ||||||
| 385 |
Schaeffer et al (2017): Semi-Field Methods for the Environmental Risk Assessment of Pesticides in Soil, CRC Press
|
No | N/A | supporting document | CRC | |||||||||
| 400 | 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) | Yes | Yes | guidance document | COMMISSION | https://food.ec.europa.eu/system/files/2017-10/pesticides_sup_monitoring-guidance_en.pdf | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 401 | WHO/FAO Pesticide Specifications. Manual on development and use of FAO and WHO specifications for chemical pesticides | Yes | Yes | guidance document | WHO/FAO | https://www.fao.org/documents/card/fr?details=CB8401EN | Active Substance Part A (chemicals)1: Identity of the active substancePPP Part A (chemicals)1: Identity of the plant protection product2: Physical, chemical and technical properties of the plant protection product |
1: Identity of the active substance (283-A), 1: Identity of the plant protection product (284-A), 2: Physical, chemical and technical properties of the plant protection product (284-A) | ||||||
| 403 | EPPO Global Database on Crops and Pests (EPPO, 2017) | Yes | Yes | guidance document,
test method |
EPPO | https://gd.eppo.int | Active Substance Part A (chemicals)3.5: Harmful organisms controlled and crops or products protected or treatedActive Substance Part B (micro-organisms)3.3: Crops or products protected or treatedPPP Part A (chemicals)3: Data on applicationPPP Part B (micro-organisms)3: Data on application |
3.5: Harmful organisms controlled and crops or products protected or treated (283-A), 3.3: Crops or products protected or treated (283-B), 3: Data on application (284-A), 3: Data on application (284-B) | Listed as guidance document in section 3.3 of Communication 283/2013 Part B and section 3 of Communication 284/2013 Part B and as test method in section 3.5 of Communication 283/2013 Part A and section 3 of Communication 284/2013 Part A | |||||
| 406 | 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) | Yes | Yes | guidance document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/5311 | Active Substance Part A (chemicals)5.8.3: Endocrine disrupting properties8.1.5: Endocrine disrupting properties 8.2.3: Endocrine disrupting properties |
5.8.3: Endocrine disrupting properties (283-A), 8.1.5: Endocrine disrupting properties (283-A), 8.2.3: Endocrine disrupting properties (283-A) | This guidance document provides that the identification of endocrine disrupting properties should be performed on a weight-of-evidence approach, taking into account all the data available, regardless of the taxa used to generate these data. | |||||
| 407 | EFSA Estimation of animal intakes and HR, STMR and MRL calculations for products of animal origin | Yes | Yes | guidance document | EFSA | https://food.ec.europa.eu/system/files/2016-10/pesticides_mrl_guidelines_animal_intake_mrl_2015_en.pdf | Active Substance Part A (chemicals)6.4: Feeding studies |
6.4: Feeding studies (283-A) | ||||||
| 408 | EFSA Spreadsheet for HR, STMR and MRL calculations for products of animal origin; EU Animal burden calculator - animals | Yes | Yes | guidance document | EFSA | https://food.ec.europa.eu/document/download/8a840d8f-b419-4755-9f22-158f0d344d8a_en?filename=pesticides_mrl_guidelines_animal_model_2017.xls | Active Substance Part A (chemicals)6.4: Feeding studies |
6.4: Feeding studies (283-A) | ||||||
| 410 | OECD MRL calculator : User guide | Yes | Yes | guidance document | OECD | https://www.oecd-ilibrary.org/docserver/9789264221567-en.pdf?expires=1675165193&id=id&accname=oid031827&checksum=3022FE1F3C9334B1548AB3E41B7301CA | Active Substance Part A (chemicals)6.7.2: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed6.7.3: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed for imported products (import tolerance) |
6.7.2: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed (283-A), 6.7.3: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed for imported products (import tolerance) (283-A) | ||||||
| 411 | ECHA Guidance on information requirements and chemical safety assessment Chapter R 11: PBT Assessment | No | N/A | supporting document | ECHA | https://echa.europa.eu/documents/10162/13632/information_requirements_r11_en.pdf/a8cce23f-a65a-46d2-ac68-92fee1f9e54f | ||||||||
| 281 | OECD Guidance Document on Overview of Residue Chemistry Studies . Series on Testing and Assessment, No. 64 and Series on Pesticides, No. 32 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/ENV/JM/MONO(2009)31/en/pdf | Active Substance Part A (chemicals)6: Residues in or on treated products, food and feed |
6: Residues in or on treated products, food and feed (283-A) | This document is partially outdated. | |||||
| 282 | 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. | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/ENV/JM/MONO(2007)17/en/pdf | Active Substance Part A (chemicals)4.1.2: Methods for risk assessment4.2: Methods for post-approval control and monitoring purposes PPP Part A (chemicals)5: Analytical methods5.1.2: Methods for the determination of residues 5.2: Methods for post-authorisation control and monitoring purposes |
4.1.2: Methods for risk assessment (283-A), 4.2: Methods for post-approval control and monitoring purposes (283-A), 5: Analytical methods (284-A), 5.1.2: Methods for the determination of residues (284-A), 5.2: Methods for post-authorisation control and monitoring purposes (284-A) | ||||||
| 283 | OECD Guidance Document on Residues in Livestock. Series on Pesticides, No. 73 | Yes | Yes | guidance document | OECD | https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2013)8&doclanguage=en | Active Substance Part A (chemicals)6.4: Feeding studies |
6.4: Feeding studies (283-A) | ||||||
| 284 | OECD Guidance document on magnitude of pesticide residues in processed commodities. Environment, Health and Safety Publications. Series on Testing and Assessment No. 96. | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/env/jm/mono(2008)23/en/pdf | Active Substance Part A (chemicals)6.5.3: Magnitude of residues in processed commodities |
6.5.3: Magnitude of residues in processed commodities (283-A) | ||||||
| 285 | OECD Guidance document on residues in rotational crops. Series on Pesticides, No. 97. and Series on Testing and Assessment, No. 279. | Yes | Yes | guidance document | OECD | https://www.oecd.org/chemicalsafety/guidance-document-on-residues-in-rotational-crops-99457f3f-en.htm | Active Substance Part A (chemicals)6.6: Residues in rotational crops |
6.6: Residues in rotational crops (283-A) | ||||||
| 286 | OECD Guidance for the Derivation of an Acute Reference Dose. Series on testing and assessment, No. 124 | Yes | Yes | guidance document | OECD | https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2010)15&doclanguage=en | Active Substance Part A (chemicals)5: Toxicological and metabolism studiesActive Substance Part B (micro-organisms)5.5: Information and toxicity studies on metabolites |
5: Toxicological and metabolism studies (283-A), 5.5: Information and toxicity studies on metabolites (283-B) | ||||||
| 287 | OECD Short guidance on the threshold approach for acute fish toxicity. Series on Testing and Aassessment, No 126 | Yes | Yes | guidance document | OECD | https://ntp.niehs.nih.gov/iccvam/suppdocs/feddocs/oecd/oecd-gd126.pdf | Active Substance Part A (chemicals)8.2.1: Acute toxicity to fish |
8.2.1: Acute toxicity to fish (283-A) | ||||||
| 288 | OECD Series on Testing and Assessment: No 148: Guidance document on the androgenised female stickleback screen | No | N/A | supporting document | OECD | https://one.oecd.org/document/ENV/JM/MONO(2011)29/en/pdf | ||||||||
| 290 | OECD Guidance notes on dermal absorption (OECD, Series on Testing and Assessment No. 156, ENV/JM/MONO (2011)36, 2011) | No | N/A | guidance document,
supporting document |
OECD | https://www.oecd.org/chemicalsafety/testing/48532204.pdf | ||||||||
| 291 | OECD Guidance Document on Crop Field Trials. Series on Testing and Assessment, No. 164 and Series on Pesticides No. 66 | Yes | Yes | guidance document | OECD | https://www.oecd.org/env/guidance-document-on-crop-field-trials-2794fdd6-en.htm | Active Substance Part A (chemicals)6.3: Magnitude of residue trials in plants |
6.3: Magnitude of residue trials in plants (283-A) | ||||||
| 292 | OECD Guidance Document on Developing and Assessing Adverse Outcome Pathways. Series on Testing and Assessment No. 184 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/env/jm/mono(2013)6/en/pdf | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 293 |
OECD (2014) "Report on Statistical Issues Related to OECD test methods (TGs) on Genotoxicity", No. 198 (ENV/JM/MONO(2014)12)
|
No | N/A | supporting document | OECD | |||||||||
| 294 | OECD Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation. Series on Testing and Assessment, No. 203 | Yes | Yes | guidance document | OECD | https://www.oecd-ilibrary.org/environment/guidance-document-on-an-integrated-approach-on-testing-and-assessment-iata-for-skin-corrosion-and-irritation_9789264274693-en | Active Substance Part A (chemicals)5.2.4: Skin irritationPPP Part A (chemicals)7.1.4: Skin irritationPPP Part B (micro-organisms)7.3.4: Skin irritation |
5.2.4: Skin irritation (283-A), 7.1.4: Skin irritation (284-A), 7.3.4: Skin irritation (284-B) | ||||||
| 295 | OECD Guidance Document for Describing Non-Guideline In-vitro Test Methods,. Series on Testing and Assessment, No. 211 | Yes | Yes | guidance document | OECD | https://www.oecd.org/publications/guidance-document-for-describing-non-guideline-in-vitro-test-methods-9789264274730-en.htm | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 296 | 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) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2021-10/pesticides_ppp_app-proc_guide_fate_metabolites-groundwtr-rev11.pdf | Active Substance Part A (chemicals)5.8.1: Toxicity studies of metabolites6.9: Estimation of the potential and actual exposure through diet and other sources |
5.8.1: Toxicity studies of metabolites (283-A), 6.9: Estimation of the potential and actual exposure through diet and other sources (283-A) | ||||||
| 297 | WHO, 2006. Environmental Health Criteria, 235. Dermal Absorption | No | N/A | supporting document | WHO | https://www.who.int/publications/i/item/9241572353 | ||||||||
| 298 | 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 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/ENV/JM/MONO(2017)15/REV1/en/pdf | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A) | ||||||
| 299 | EFSA Guidance on Uncertainty Analysis in Scientific Assessments (EFSA Journal 2018;16(1):5123) | Yes | Yes | guidance document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/5123 | https://food.ec.europa.eu/document/download/1699d805-16d7-44fe-b97a-a3435ba59446_en?filename=pesticides_ppp_app-proc_guide_horiz_uncertain-analysis.pdf | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | Guidance of EFSA on uncertainty analysis 14 July 2022 (PAFF-PPL-July22-Doc.A.07.02): https://food.ec.europa.eu/system/files/2022-08/pesticides_ppp_app-proc_guide_horiz_uncertain-analysis.pdf | ||||
| 302 | EFSA (2017). Technical report on the outcome of the pesticides peer review meeting on the OECD 106 evaluators checklist. EFSA supporting publication 2017:EN-1326 | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/supporting/pub/en-1326 | ||||||||
| 303 | EFSA Application of systematic review methodology to food and feed safety assessments to support decision making (EFSA Journal 2010;8(6):1637) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2010.1637 | Active Substance Part A (chemicals)9: Literature dataPPP Part A (chemicals)11: Literature data |
9: Literature data (283-A), 11: Literature data (284-A) | ||||||
| 304 | 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) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2011.2092 | Active Substance Part A (chemicals)9: Literature dataActive Substance Part B (micro-organisms)0: General Guidance3.5: Literature data PPP Part A (chemicals)11: Literature data |
9: Literature data (283-A), 0: General Guidance (283-B), 3.5: Literature data (283-B), 11: Literature data (284-A) | ||||||
| 305 | EFSA Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment. (EFSA Journal 2011;9(9):2379) | Yes | Yes | guidance document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/2379 | Active Substance Part A (chemicals)5.4: Genotoxicity testing |
5.4: Genotoxicity testing (283-A) | ||||||
| 308 | 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) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2019-03/pesticides_ppp_app-proc_guide_phys-chem-ana_3030.pdf | Active Substance Part A (chemicals)4.1.1: Methods for the analysis of the active substance as manufacturedActive Substance Part B (micro-organisms)4.1: Methods for the analysis of the MPCA as manufacturedPPP Part A (chemicals)5.1.1: Methods for the analysis of the plant protection productPPP Part B (micro-organisms)5.1: Methods for the analysis of the preparation |
4.1.1: Methods for the analysis of the active substance as manufactured (283-A), 4.1: Methods for the analysis of the MPCA as manufactured (283-B), 5.1.1: Methods for the analysis of the plant protection product (284-A), 5.1: Methods for the analysis of the preparation (284-B) | ||||||
| 310 | EFSA Guidance on the use of the benchmark dose approach in risk assessment (EFSA Journal 2017;15(1):4658) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4658 | Active Substance Part A (chemicals)0: General Guidance |
0: General Guidance (283-A) | ||||||
| 311 | 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)) | Yes | Yes | guidance document | SANTE | https://esdac.jrc.ec.europa.eu/projects/surface-water | PPP Part A (chemicals)9.2.2: Water/sediment study9.2.5: Estimation of concentrations in surface water and sediment |
9.2.2: Water/sediment study (284-A), 9.2.5: Estimation of concentrations in surface water and sediment (284-A) | The generic FOCUS guidance documents that are based on the relevant, more specific guidance documents and regularly updated are listed. | |||||
| 312 | EFSA Guidance on the assessment of the biological relevance of data in scientific assessments (EFSA Journal 2017;15(8):4970) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4970 | https://food.ec.europa.eu/document/download/0983fd29-ddca-4d6f-b6d1-544f2eb2e10c_en?filename=pesticides_ppp_app-proc_guide_horiz_bio-relev-data.pdf | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | Guidance on the assessment of the biological relevance of data in scientific assessments. PAFF-PPL-July22-Doc.A.07.03: https://food.ec.europa.eu/system/files/2022-08/pesticides_ppp_app-proc_guide_horiz_bio-relev-data.pdf | ||||
| 313 | EFSA Scientific Opinion on the guidance on the use of the weight of evidence approach in scientific assessments (EFSA Journal 2017;15(8):4971) | Yes | Yes | guidance document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/4971 | https://food.ec.europa.eu/document/download/41bd0309-16b9-4882-961d-4ae8f4a934e7_en?filename=pesticides_ppp_app-proc_guide_horiz_weight-ev.pdf | Active Substance Part A (chemicals)0: General GuidanceActive Substance Part B (micro-organisms)0: General GuidancePPP Part A (chemicals)0: General GuidancePPP Part B (micro-organisms)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (283-B), 0: General Guidance (284-A), 0: General Guidance (284-B) | Guidance on the use of the weight of evidence approach in scientific assessments. PAFF-PPL-July22-Doc.A.07.01: https://food.ec.europa.eu/system/files/2022-08/pesticides_ppp_app-proc_guide_horiz_weight-ev.pdf | ||||
| 314 | EFSA Scientific Opinion, Clarification of some aspects related to genotoxicity assessment (EFSA Journal 2017;15(12):5113) | Yes | Yes | guidance document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/5113 | Active Substance Part A (chemicals)5.4: Genotoxicity testing |
5.4: Genotoxicity testing (283-A) | ||||||
| 315 | 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) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_aas_guidance_sclps_en.pdf | Active Substance Part A (chemicals)0: General Guidance |
0: General Guidance (283-A) | ||||||
| 316 | EU guidance document "Calculation of Maximum Residue Levels and Safety Intervals e.g. Pre-harvest Intervals" (SANCO 7039/VI/95) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_mrl_guidelines_app-i.pdf | Active Substance Part A (chemicals)6.8: Proposed safety intervals |
6.8: Proposed safety intervals (283-A) | ||||||
| 317 | EU Working Document. Draft Guidance for the Setting and Application of Acceptable Operator Exposure Levels (AOEL’s) (SANCO/7531/2006) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_tox_accpt-exp-levs-2006.pdf | Active Substance Part A (chemicals)5: Toxicological and metabolism studies |
5: Toxicological and metabolism studies (283-A) | ||||||
| 318 | Soil persistence models and EU registration, final report of the FOCUS Soil modelling workgroup, Sanco/7617/VI/96 | Yes | Yes | guidance document | SANTE | https://esdac.jrc.ec.europa.eu/public_path/u891/Soil%20persistence%20models%20and%20EU%20registration%E2%80%99%20%281997%29.pdf | PPP Part A (chemicals)9.1.3: Estimation of concentrations in soil |
9.1.3: Estimation of concentrations in soil (284-A) | ||||||
| 320 | 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) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_efficacy_nas.pdf | PPP Part A (chemicals)6: Efficacy dataPPP Part B (micro-organisms)6: Efficacy data |
6: Efficacy data (284-A), 6: Efficacy data (284-B) | ||||||
| 602 | OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-460-fluorescein-leakage-test-method-for-identifying-ocular-corrosives-and-severe-irritants_9789264185401-en | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritationPPP Part B (micro-organisms)7.3.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A), 7.3.5: Eye irritation (284-B) | ||||||
| 603 | 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 | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264242432-en.pdf?expires=1673877664&id=id&accname=guest&checksum=AE68F550BDAAE7D97E99CCD85A9C7F01 | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritationPPP Part B (micro-organisms)7.3.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A), 7.3.5: Eye irritation (284-B) | ||||||
| 604 | 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 | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264242548-en.pdf?expires=1673877694&id=id&accname=oid031827&checksum=5A55F5D29CCF5B8F4EFF91BD5BFDC806 | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritationPPP Part B (micro-organisms)7.3.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A), 7.3.5: Eye irritation (284-B) | ||||||
| 605 | OECD Test Guideline 405: Acute eye irritation/corrosion | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264185333-en.pdf?expires=1673877716&id=id&accname=guest&checksum=E7F7535CAACDF677F1D4FE9A45D108D5 | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritationPPP Part B (micro-organisms)7.3.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A), 7.3.5: Eye irritation (284-B) | ||||||
| 606 | OECD Test Guideline 442B: Skin Sensitisation – Local Lymph Node Assay: BrdU-ELISA | Yes | N/A | test method | OECD | https://www.oecd.org/env/test-no-442b-skin-sensitization-9789264090996-en.htm | Active Substance Part A (chemicals)5.2.6: Skin sensitisationPPP Part A (chemicals)7.1.6: Skin sensitisationPPP Part B (micro-organisms)7.3.6: Skin sensitisation |
5.2.6: Skin sensitisation (283-A), 7.1.6: Skin sensitisation (284-A), 7.3.6: Skin sensitisation (284-B) | ||||||
| 419 | Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances (SANTE/10182/2021) | No | Yes | guidance document | EFSA | Procedural guidance document- dossier and draft assessment report | https://efsa.onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6464 | https://food.ec.europa.eu/document/download/56b8229b-e013-4d0a-ab38-b31bfeb88038_en?filename=pesticides_ppp_app-proc_guide_peer-review-active-subs_en.pdf | ||||||
| 423 | Basic substances – Working document on the procedure for application of basic substances to be approved in compliance with Article 23 of Regulation (EC) No 1107/2009 (SANCO/10363/2012) | No | N/A | supporting document | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/document/download/653f031e-a7c8-415b-9705-8531a13829dc_en?filename=pesticides_ppp_app-proc_guide_doss_swd-10363-2012.pdf | ||||||||
| 425 | ECHA (2017) "Guidance on Information Requirements and Chemical Safety Assessment - Chapter R.7a: Endpoint Specific Guidance" | No | N/A | supporting document | ECHA | https://op.europa.eu/en/publication-detail/-/publication/182ca463-f427-11e7-9d43-01aa75ed71a1/language-en | ||||||||
| 429 | OECD Revised Guidance Document No. 150 on Standardised test methods for Evaluating Chemicals for Endocrine Disruption. | Yes | Yes | guidance document | OECD | https://www.oecd-ilibrary.org/docserver/9789264304741-en.pdf?expires=1675352787&id=id&accname=oid031827&checksum=C644AB9D07B893EBC910D4E12A40DED3 | Active Substance Part A (chemicals)5.8.3: Endocrine disrupting properties8.1.5: Endocrine disrupting properties 8.2.3: Endocrine disrupting properties |
5.8.3: Endocrine disrupting properties (283-A), 8.1.5: Endocrine disrupting properties (283-A), 8.2.3: Endocrine disrupting properties (283-A) | This guidance contains information about the relevant test methods and is regularly updated. | |||||
| 430 | Technical guidance on the interpretation of points 3.6.3. to 3.6.5, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, in particular regarding the assessment of negligible exposure to an active substance in a plant protection product under realistic conditions of use (SANCO-2014-12096) | No | N/A | guidance document | COM | https://food.ec.europa.eu/system/files/2017-02/adv-grp_wg_20150625_tech-guidance.pdf | Commission Notice | |||||||
| 431 | EFSA Guidance on the establishment of the residue definition for dietary risk assessment (EFSA Journal 2016;14(12):4549) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2016.4549 | PPP Part B (micro-organisms)8: Residues in or on treated products, food and feed |
8: Residues in or on treated products, food and feed (284-B) | ||||||
| 433 |
Zonal (North) Guidance on risk assessment Birds and Mammals
|
No | N/A | guidance document | zonal GD | |||||||||
| 346 | 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) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2021-12/pesticides_ppp_app-proc_guide_phys-chem-ana_chem-subst.pdf | PPP Part A (chemicals)2: Physical, chemical and technical properties of the plant protection product4: Further information on the plant protection product |
2: Physical, chemical and technical properties of the plant protection product (284-A), 4: Further information on the plant protection product (284-A) | ||||||
| 347 | EU Guidance on dermal adsorption (SANTE/2018/10591) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2017.4873 | https://food.ec.europa.eu/system/files/2018-11/pesticides_ppp_app-proc_guide_tox_dermal-absorp-2018-paff.pdf | PPP Part A (chemicals)7.3: Dermal absorptionPPP Part B (micro-organisms)7.5: Data on exposure |
7.3: Dermal absorption (284-A), 7.5: Data on exposure (284-B) | link to EFSA document: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4873 | ||||
| 348 | Guidance document for environmental risk assessments of active substances used on rice in the EU for Annex 1 inclusion (SANCO/1090/2000) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_crop_rice.pdf | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 349 | Risk assessment for birds and mammals: Joint working group report on the birds and mammals guidance document - 31 July 2009 | No | N/A | supporting document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_ecotox_ra_birds-mammals-jwg.pdf | ||||||||
| 351 | EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents, section 3.1.2 (SANCO/12117/2012) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_fate_wd-env-sft-eval-mbca.pdf | Active Substance Part B (micro-organisms)7.1.1.1: Soil7.1.1.2: Water 8: Ecotoxicological studies |
7.1.1.1: Soil (283-B), 7.1.1.2: Water (283-B), 8: Ecotoxicological studies (283-B) | ||||||
| 352 | 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) | Yes | Yes | guidance document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/3615 | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_fate_efsa_protected-crops.pdf | PPP Part A (chemicals)9: Fate and behaviour in the environment |
9: Fate and behaviour in the environment (284-A) | |||||
| 353 | 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) | Yes | Yes | guidance document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/5804 | https://food.ec.europa.eu/document/download/40be858d-c378-4d58-958c-cf0ee2a1f5cc_en?filename=pesticides_ppp_app-proc_guide_horiz_stereoisomers.pdf | Active Substance Part A (chemicals)0: General Guidance |
0: General Guidance (283-A) | |||||
| 354 | Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments EC Document Reference (SANTE/12586/2020) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2022-02/pesticides_ppp_app-proc_guide_fate_aged-sorption_0.pdf | Active Substance Part A (chemicals)7.1.3.2: Aged sorption |
7.1.3.2: Aged sorption (283-A) | ||||||
| 355 | Short guidance on the threshold approach for acute fish toxicity (OECD. Series on testing and assessment No 126. ENV/JM/MONO(2010)17) | No | N/A | supporting document | OECD | https://one.oecd.org/document/env/jm/mono(2010)17/en/pdf | ||||||||
| 356 | 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) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_formulation-change.pdf | PPP Part A (chemicals)0: General GuidancePPP Part B (micro-organisms)1.4: Detailed quantitative and qualitative information on the composition of the preparation |
0: General Guidance (284-A), 1.4: Detailed quantitative and qualitative information on the composition of the preparation (284-B) | ||||||
| 358 | 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) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2023-05/pesticides_mrl_guidelines_app-d.pdf | Active Substance Part A (chemicals)6.3: Magnitude of residue trials in plants6.7.2: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed 6.7.3: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed for imported products (import tolerance) |
6.3: Magnitude of residue trials in plants (283-A), 6.7.2: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed (283-A), 6.7.3: Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed for imported products (import tolerance) (283-A) | ||||||
| 359 | 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) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_equiv_micro-organisms.pdf | Active Substance Part B (micro-organisms)1: Identity of the applicant, identity of the active substance and manufacturing informationPPP Part B (micro-organisms)1: Identity of the applicant, identity of the plant protection product and manufacturing information |
1: Identity of the applicant, identity of the active substance and manufacturing information (283-B), 1: Identity of the applicant, identity of the plant protection product and manufacturing information (284-B) | ||||||
| 360 | EFSA Risk assessment for birds and mammals (EFSA Journal 2009; 7(12):1438) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2009.1438 | Active Substance Part A (chemicals)8.1: Effects on birds and other terrestrial vertebratesPPP Part A (chemicals)10.1: Effects on birds and other terrestrial vertebrates |
8.1: Effects on birds and other terrestrial vertebrates (283-A), 10.1: Effects on birds and other terrestrial vertebrates (284-A) | ||||||
| 363 | Risk assessment for birds and mammals - 25 September 2002 | No | N/A | supporting document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_ecotox_ra_birds-mammals.pdf | ||||||||
| 364 | OECD Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting test methods 451, 452 and 453 | Yes | Yes | guidance document | OECD | https://www.oecd-ilibrary.org/docserver/9789264221475-en.pdf?expires=1673861877&id=id&accname=oid031827&checksum=89FA4EFDCCC8D1A67A155680E5D1B1F6 | Active Substance Part A (chemicals)5.5: Long-term toxicity and carcinogenicity5.6: Reproductive toxicity |
5.5: Long-term toxicity and carcinogenicity (283-A), 5.6: Reproductive toxicity (283-A) | ||||||
| 365 | Guidance document on the finalisation of the reference specification for technical active substances after the peer review (SANCO/6075/2009) | No | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_sanco-2009-6075_rev-03.pdf | ||||||||
| 275 | OECD Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application, Series on Testing and Assessment No. 9 | Yes | Yes | guidance document | OECD | https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ocde/gd(97)148&doclanguage=en | PPP Part A (chemicals)7.2.1: Operator exposure7.2.3: Worker exposure |
7.2.1: Operator exposure (284-A), 7.2.3: Worker exposure (284-A) | ||||||
| 276 | Technical Monograph N° 17. Guidelines for Specifying the Shelf Life of Plant Protection Products (2nd edition, CropLife International, 2009) | No | N/A | supporting document | Croplife | https://croplife.org/wp-content/uploads/2021/04/CLI-TM-17-Guideline-for-Shelf-Life_FINAL.pdf | ||||||||
| 277 | 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) | Yes | Yes | guidance document | OECD | https://www.oecd-ilibrary.org/docserver/0ed2f88e-en.pdf?expires=1673865235&id=id&accname=oid031827&checksum=1A13F3B796FCCFC8EBC0C517A726DE1D | Active Substance Part A (chemicals)8.2: Effects on aquatic organismsPPP Part A (chemicals)10.2: Effects on aquatic organisms |
8.2: Effects on aquatic organisms (283-A), 10.2: Effects on aquatic organisms (284-A) | ||||||
| 278 | OECD Guidance Notes for Analysis and Evaluation of Repeat-Dose Toxicity Studies. Series on Testing and Assessment, No. 32 | Yes | Yes | guidance document | OECD | https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2000)18&doclanguage=en | Active Substance Part A (chemicals)5.3: Short-term toxicity |
5.3: Short-term toxicity (283-A) | ||||||
| 279 | OECD Current approaches in the statistical analysis of ecotoxicity data: a guidance to application. Series of testing and assessment, No 54 | Yes | Yes | guidance document | OECD | https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2006)18&doclanguage=en | Active Substance Part A (chemicals)8: Ecotoxicological studiesPPP Part A (chemicals)10: Ecotoxicological studies |
8: Ecotoxicological studies (283-A), 10: Ecotoxicological studies (284-A) | ||||||
| 280 | 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 | Yes | N/A | guidance document | OECD | https://one.oecd.org/document/ENV/JM/MONO(2009)30/en/pdf | Active Substance Part A (chemicals)6.7.1: Proposed residue definitions |
6.7.1: Proposed residue definitions (283-A) | ||||||
| 439 | Guidance document for applicants on preparing dossiers for the approval of a chemical new active substance and for the renewal of approval of a chemical active substance according to Regulation (EU) No 283/2013 and Regulation (EU) No 284/2013 (SANCO/10181/2013) | No | Yes | guidance document | SANTE | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/document/download/22155148-272d-4784-8d38-02daaca4f557_en?filename=pesticides_ppp_app-proc_guide_doss_10181.pdf | word version can be found here: https://food.ec.europa.eu/document/download/e1c99be3-e686-4afd-9122-dde937f1700b_en?filename=pesticides_ppp_app-proc_guide_doss_10181.doc | ||||||
| 440 | Guidance document on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009 (SANCO/13169/2010) | No | No | guidance document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/system/files/2021-01/pesticides_aas_guidance_mut_rec_en.pdf | |||||||
| 441 | Guidance document on the preparation and submission of dossiers for plant protection products according to the “risk envelope approach” (SANCO/11244/2011) | No | Yes | guidance document,
supporting document |
SANTE | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_doss_risk-env_20110314.pdf | |||||||
| 444 | Good Laboratory Practice - detailed requirements for Part A, Annexes II and III - 7109/VI/94 - July 1995 | No | N/A | supporting document | COM | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/document/download/1e9d1207-60f2-4053-8798-502c2ac92b0c_en?filename=pesticides_ppp_app-proc_guide_doss_glp_7109-vi-94.pdf | |||||||
| 445 | 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 | Yes | Yes | guidance document | SETAC | https://www.worldcat.org/title/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-a-joint-bart-eppocoe-oecd-and-iobc-workshop-organised-in-conjunction-with-setac-europe-and-ec-held-at-wageningen-international-conference-centre-wageningen-the-netherlands-21-23-march-2000/oclc/51023953 | Active Substance Part A (chemicals)8.3.2: Effects on non-target arthropods other than beesPPP Part A (chemicals)10.3.2: Effects on non-target arthropods other than bees |
8.3.2: Effects on non-target arthropods other than bees (283-A), 10.3.2: Effects on non-target arthropods other than bees (284-A) | website is not accesible for reading the document | |||||
| 446 | SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides | Yes | Yes | guidance document | SETAC | https://www.setac.org/resource/assessing-fate-ecotox-pesticides-1995.html | Active Substance Part A (chemicals)7.1.1.3: Soil photolysis |
7.1.1.3: Soil photolysis (283-A) | ||||||
| 452 | OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides, No. 82 / Series on Testing and Assessment, No. 232. | Yes | Yes | guidance document,
test method |
OECD | https://one.oecd.org/document/ENV/JM/MONO(2016)6/en/pdf | Active Substance Part A (chemicals)7.1.2.2: Field studiesPPP Part A (chemicals)9.1.1.2: Field studies9.1.2.3: Field leaching studies 9.2.4.2: Additional field tests |
7.1.2.2: Field studies (283-A), 9.1.1.2: Field studies (284-A), 9.1.2.3: Field leaching studies (284-A), 9.2.4.2: Additional field tests (284-A) | ||||||
| 454 | OECD Guidance Documents on the Validation of (Quantitative) Structure-Activity Relationship [(Q)SAR] Models. Series on Testing and Assessment No. 69. | Yes | Yes | guidance document | OECD | https://www.oecd.org/env/guidance-document-on-the-validation-of-quantitative-structure-activity-relationship-q-sar-models-9789264085442-en.htm | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 455 | OECD Guidance on Grouping of Chemicals, Second Edition. Series on Testing and Assessment, No. 194 | Yes | Yes | guidance document | OECD | https://www.oecd.org/publications/guidance-on-grouping-of-chemicals-second-edition-9789264274679-en.htm | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 458 | De Jong et al. (2010) Guidance for summarising and evaluating field studies with non-target arthropods | Yes | Yes | guidance document | RIVM | https://rivm.openrepository.com/bitstream/handle/10029/259135/601712006.pdf?sequence=3&isAllowed=y | Active Substance Part A (chemicals)8.3.2: Effects on non-target arthropods other than beesPPP Part A (chemicals)10.3.2: Effects on non-target arthropods other than bees |
8.3.2: Effects on non-target arthropods other than bees (283-A), 10.3.2: Effects on non-target arthropods other than bees (284-A) | ||||||
| 459 | EFSA European Food Safety Authority 2020. Scientific report of EFSA on the ‘repair action’ of the FOCUS surface water scenarios. EFSA Journal 2020;18(5):6119, 294 | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/6119 | ||||||||
| 460 | OECD Guidance Document for flammability testing of plant protection and biocidal products, Series on Testing and Assessment, No. 330 | Yes | Yes | guidance document | OECD | https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2020)31&doclanguage=en | Active Substance Part A (chemicals)2.9: Flammability and self-heatingPPP Part A (chemicals)2.3: Flammability and self-heating |
2.9: Flammability and self-heating (283-A), 2.3: Flammability and self-heating (284-A) | ||||||
| 461 | OECD Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA) No. 260 | Yes | Yes | guidance document | OECD | https://www.oecd-ilibrary.org/environment/guidance-document-for-the-use-of-adverse-outcome-pathways-in-developing-integrated-approaches-to-testing-and-assessment-iata_44bb06c1-en | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General GuidancePPP Part B (micro-organisms)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A), 0: General Guidance (284-B) | ||||||
| 462 | EFSA Scientific Committee, 2019. Statement on the genotoxicity assessment of chemical mixtures. EFSA Journal 2019;17(1):5519 | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/5519 | ||||||||
| 463 | OECD Consideration for assessing the risk of combined exposure to multiple chemicals. Series on Testing and Assessment No. 296 | Yes | Yes | guidance document | OECD | https://www.oecd.org/chemicalsafety/considerations-for-assessing-the-risks-of-combined-exposure-to-multiple-chemicals-ceca15a9-en.htm | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 464 | 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) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5634 | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 465 | 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 | Yes | Yes | guidance document | OECD | https://www.oecd.org/chemicalsafety/risk-assessment/guidance-document-on-the-characterisation-validation-and-reporting-of-physiologically-based-kinetic-models-for-regulatory-purposes.pdf | Active Substance Part A (chemicals)5.1: Studies on absorption, distribution, metabolism and excretion in mammals |
5.1: Studies on absorption, distribution, metabolism and excretion in mammals (283-A) | ||||||
| 467 | OECD Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests. Series on Testing & Assessment, No. 237 | Yes | Yes | guidance document | OECD | https://web-archive.oecd.org/2016-08-03/410809-mono%202016%2032.pdf | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General GuidancePPP Part B (micro-organisms)7.3: Acute toxicity |
0: General Guidance (283-A), 0: General Guidance (284-A), 7.3: Acute toxicity (284-B) | ||||||
| 468 | OECD Guidance Document for Neurotoxicity Testing. OECD Series on Testing and Assessment, No 20 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/env/jm/mono(2004)25/en/pdf | Active Substance Part A (chemicals)5.7: Neurotoxicity studies |
5.7: Neurotoxicity studies (283-A) | ||||||
| 469 | OECD Guidance document on acute oral toxicity testing. Series on Testing and Assessment, No. 24 | Yes | Yes | guidance document | OECD | https://www.oecd-ilibrary.org/environment/guidance-document-on-acute-oral-toxicity-testing_9789264078413-en | Active Substance Part A (chemicals)5.2.1: OralPPP Part A (chemicals)7.1.1: Oral toxicity |
5.2.1: Oral (283-A), 7.1.1: Oral toxicity (284-A) | ||||||
| 470 | OECD Guidance Document on using Cytotoxicity Tests to Estimate Starting Doses for Acute Oral Systemic Toxicity Tests. Series on Testing and Assessment, No. 129 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/env/jm/mono(2010)20/en/pdf | Active Substance Part A (chemicals)5.2.1: OralPPP Part A (chemicals)7.1.1: Oral toxicity |
5.2.1: Oral (283-A), 7.1.1: Oral toxicity (284-A) | ||||||
| 471 | 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 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/ENV/JM/MONO(2011)45/en/pdf | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A) | ||||||
| 472 | OECD. The Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent Binding to Proteins. Series on Testing and Assessment No. 168. | No | N/A | supporting document | OECD | https://www.oecd.org/env/the-adverse-outcome-pathway-for-skin-sensitisation-initiated-by-covalent-binding-to-proteins-9789264221444-en.htm | ||||||||
| 473 | OECD. Guidance Document on the Reporting of Defined Approaches and Individual Information Sources to be used within Integrated Approaches to Testing and Assessment (IATA) for Skin Sensitisation. Series on Testing and Assessment No. 256 | No | N/A | guidance document | OECD | https://www.oecd.org/publications/guidance-document-on-the-reporting-of-defined-approaches-and-individual-information-sources-to-be-used-within-integrated-9789264279285-en.htm | ||||||||
| 474 | 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 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/env/jm/mono(2010)16/en/pdf | Active Substance Part A (chemicals)5.3.3: Other routes |
5.3.3: Other routes (283-A) | ||||||
| 475 | OECD Guidance Document for Histologic Evaluation of Endocrine and Reproductive Tests in Rodents. Series on Testing and Assessment No. 106 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/env/jm/mono(2009)11/en/pdf | Active Substance Part A (chemicals)5.6: Reproductive toxicity |
5.6: Reproductive toxicity (283-A) | ||||||
| 476 | OECD Guidance Document on Mammalian Reproductive Toxicity Testing and Assessment. Series on Testing and Assessment, No 43 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/env/jm/mono(2008)16/en/pdf | Active Substance Part A (chemicals)5.6: Reproductive toxicity |
5.6: Reproductive toxicity (283-A) | ||||||
| 477 | North American Free Trade Agreement (NAFTA) Technical Working Group on Pesticides (TWG) Developmental Neurotoxicity Study Guidance Document | Yes | Yes | guidance document | NAFTA | https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/developmental-neurotoxicity-study-guidance | Active Substance Part A (chemicals)5.6.2: Developmental toxicity studies |
5.6.2: Developmental toxicity studies (283-A) | ||||||
| 478 | 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 | Yes | Yes | guidance document | OECD | https://www.oecd-ilibrary.org/environment/revised-guidance-document-150-on-standardised-test-guidelines-for-evaluating-chemicals-for-endocrine-disruption/developmental-neurotoxicity-study-oecd-tg-426_9789264304741-27-en | Active Substance Part A (chemicals)5.6.2: Developmental toxicity studies |
5.6.2: Developmental toxicity studies (283-A) | ||||||
| 479 | EFSA Literature review and appraisal on alternative neurotoxicity testing methods, doi:10.2903/sp.efsa.2018.EN-1410 | No | N/A | supporting document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/sp.efsa.2018.EN-1410 | ||||||||
| 480 | Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/supporting/pub/en-1837 | ||||||||
| 484 | ICH Safety Guidelines S10 Photosafety Evaluation of Pharmacetuticals | Yes | Yes | guidance document | ICH | https://www.ema.europa.eu/en/ich-s10-photosafety-evaluation-pharmaceuticals-scientific-guideline | Active Substance Part A (chemicals)5.2.7: Phototoxicity5.4: Genotoxicity testing |
5.2.7: Phototoxicity (283-A), 5.4: Genotoxicity testing (283-A) | ||||||
| 485 | ICH Safety Guidelines S8 Immunotoxicity studies for Human Pharmaceuticals | Yes | N/A | test method | ICH | https://www.ema.europa.eu/en/ich-s8-immunotoxicity-studies-human-pharmaceuticals-scientific-guideline#:~:text=This%20document%20provides%20recommendations%20on%20non-clinical%20testing%20for,immunosuppression%20and%20immunoenhancement%2C%20excluding%20allergenicity%20or%20drug-specific%20autoimmunity. | Active Substance Part A (chemicals)5.8.2: Supplementary studies on the active substance |
5.8.2: Supplementary studies on the active substance (283-A) | ||||||
| 489 | Statement of the PPR Panel on a framework for conducting the environmental exposure and risk assessment for transition metals when used as active substances in plant protec-tion products (PPP)´ (EFSA Journal 2021;19(3):6498) | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/6498 | ||||||||
| 547 | Guidance document on the procedures relating to the authorisation of plant protection products following inclusion of an existing active substance in Annex I of Council Directive 91/414/EEC (Sanco/10796/2003) | No | No | guidance document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/document/download/ccdf56ad-62a3-4dfe-99d6-2df6b43bf005_en?filename=pesticides_aas_guidance_re_reg_guidance_10_4_as_noted_on_2_10_2009.pdf | |||||||
| 549 | Guidance document concerning the parallel trade of plant protection products (SANCO/10524/2012) | No | No | guidance document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/system/files/2016-10/pesticides_aas_guidance_wrkdoc18_en.pdf | |||||||
| 550 | Renewal Guidance on implementation of Regulation (EU) No 1141/2010 (SANCO/10387/2010) | No | Yes | guidance document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/document/download/7d72a8b5-fc06-4f1c-b53c-6a3205d07978_en?filename=pesticides_aas_guidance_air_2_rev_8102010.pdf | |||||||
| 551 | Guidance document on data matching for applications for plant protection product authorisations according to Articles 33 and 43 of Regulation (EC) No 1107/2009 (SANTE/2016/11449) | No | No | guidance document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/document/download/5dbc19d2-59f6-46b9-ad8b-ea2dad62daa9_en?filename=pesticides_aas_guidance_proc_sante-2016-11449.pdf | |||||||
| 552 | Template for Submission Demonstrating Access to a Complete Package According to Regulation (EU) 283/2013 and for the Data Matching Step (SANTE/2016/11449) | No | N/A | supporting document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/system/files/2017-06/pesticides_aas_guidance_template_data-matching-table.pdf | |||||||
| 553 | Technical Guidelines on Data Protection according to Regulation (EC) No 1107/2009 | No | N/A | supporting document | SANTE | Procedural guidance document- other | https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2019:229:FULL | |||||||
| 556 | WHO Guidelines for drinking water quality | Yes | Yes | guidance document | WHO | https://www.who.int/publications/i/item/9789241549950 | Active Substance Part A (chemicals)6.9: Estimation of the potential and actual exposure through diet and other sources |
6.9: Estimation of the potential and actual exposure through diet and other sources (283-A) | ||||||
| 557 | 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) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.7119 | https://food.ec.europa.eu/document/download/6b7b3dd2-b668-423f-b365-33019f27b588_en?filename=pesticides_ppp_app-proc_guide_phototransformation-groundwater.pdf | Active Substance Part A (chemicals)7.1.1.3: Soil photolysisPPP Part A (chemicals)9.2.4: Estimation of concentrations in groundwater |
7.1.1.3: Soil photolysis (283-A), 9.2.4: Estimation of concentrations in groundwater (284-A) | |||||
| 558 | OECD Test Guideline 102: Melting Point/ Melting Range | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264069527-en.pdf?expires=1673867070&id=id&accname=ocid194935&checksum=8DC5FC41E19162EF2EB1CB35BA9F5663 | Active Substance Part A (chemicals)2.1: Melting point and boiling point |
2.1: Melting point and boiling point (283-A) | ||||||
| 559 | OECD Test Guideline 103: Boiling point | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-103-boiling-point_9789264069541-en#:~:text=Test%20No.%20103%3A%20Boiling%20Point%20This%20Test%20Guideline,pressure%20equals%20the%20standard%20atmospheric%20pressure%20101.325%20kPa. | Active Substance Part A (chemicals)2.1: Melting point and boiling point |
2.1: Melting point and boiling point (283-A) | ||||||
| 560 | OECD Test Guideline 104: Vapour Pressure | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-104-vapour-pressure_9789264069565-en#:~:text=Test%20No.%20104%3A%20Vapour%20Pressure.%20This%20Test%20Guideline,and%20is%20determined%20at%20various%20temperatures%20%28in%20Kelvin%29. | Active Substance Part A (chemicals)2.2: Vapour pressure, volatility |
2.2: Vapour pressure, volatility (283-A) | ||||||
| 562 | OECD Test Guideline 101: UV-VIS Absorption Spectra | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-101-uv-vis-absorption-spectra_9789264069503-en | Active Substance Part A (chemicals)2.4: Spectra (UV/VIS, IR, NMR, MS), molar extinction at relevant wavelengths, optical purity5.2.7: Phototoxicity |
2.4: Spectra (UV/VIS, IR, NMR, MS), molar extinction at relevant wavelengths, optical purity (283-A), 5.2.7: Phototoxicity (283-A) | ||||||
| 563 | CIPAC Method MT 181: Solubility in organic solvents | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/158-mt-181-solubility-in-organic-solvents?catid=2:uncategorised&Itemid=210#:~:text=The%20solubility%20-%20within%20predefined%20ranges%20-%20of,determine%20the%20approximate%20solubility%20of%20the%20test%20substance. | Active Substance Part A (chemicals)2.6: Solubility in organic solvents |
2.6: Solubility in organic solvents (283-A) | ||||||
| 564 | CIPAC Method MT 157: Water solubility | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/109-mt-157-water-solubility?Itemid=210 | Active Substance Part A (chemicals)2.6: Solubility in organic solvents |
2.6: Solubility in organic solvents (283-A) | may be adapted in some circumstances | |||||
| 566 | OECD Test Guideline 117: Partition Coefficient (n-octanol/water), HPLC method | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-117-partition-coefficient-n-octanol-water-hplc-method_9789264069824-en#:~:text=Test%20No.%20117%3A%20Partition%20Coefficient%20%28n-octanol%2Fwater%29%2C%20HPLC%20Method,containing%20long%20hydrocarbon%20chains%20chemically%20bound%20onto%20silica. | Active Substance Part A (chemicals)2.7: Partition coefficient n-octanol/water |
2.7: Partition coefficient n-octanol/water (283-A) | ||||||
| 567 | OECD Test Guideline 123: Partition coefficient (1-octanol/water): slow-stirring method | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264015845-en.pdf?expires=1673868180&id=id&accname=guest&checksum=1C5F42575C318C466A892888B1B3B11D | Active Substance Part A (chemicals)2.7: Partition coefficient n-octanol/water |
2.7: Partition coefficient n-octanol/water (283-A) | ||||||
| 568 | OECD Test Guideline 112: Dissociation Constants in Water. | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-112-dissociation-constants-in-water_9789264069725-en | Active Substance Part A (chemicals)2.8: Dissociation in water |
2.8: Dissociation in water (283-A) | ||||||
| 569 | Test N.1: test method for flammable solids, Part III of UN RTDG Manual of Tests and Criteria | Yes | N/A | test method | UN RTDG | https://unece.org/sites/default/files/2023-11/ST_SG_AC.10_11_Rev.8e_WEB.pdf | Active Substance Part A (chemicals)2.9: Flammability and self-heatingPPP Part A (chemicals)2.3: Flammability and self-heating |
2.9: Flammability and self-heating (283-A), 2.3: Flammability and self-heating (284-A) | ||||||
| 570 | Method A.15 Auto-ignition temperature (liquids and gases), Part A of Commission Regulation (EC) No. 440/2008 | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.9: Flammability and self-heatingPPP Part A (chemicals)2.3: Flammability and self-heating |
2.9: Flammability and self-heating (283-A), 2.3: Flammability and self-heating (284-A) | title of the method for the section 2.9 Flammability and self-heating- self-heating in the Communication 283/2013: Method A.15(Annex of Regulation (EC) No. 440/2008) for liquids and Gases (liquids and gases) | |||||
| 571 | Method A.16 Relative self-ignition temperature for solids, Part A of Commission Regulation (EC) No. 440/2008) | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.9: Flammability and self-heatingPPP Part A (chemicals)2.3: Flammability and self-heating |
2.9: Flammability and self-heating (283-A), 2.3: Flammability and self-heating (284-A) | title of the method for the section 2.9 Flammability and self-heating- self-heating in the Communication 283/2013: Method A.16(Annex of Regulation (EC) No. 440/2008) for solids (solids) | |||||
| 572 | Test N.4: test method for self-heating substances Part III of of UN RTDG Manual of Tests and Criteria | Yes | N/A | test method | UN RTDG | https://unece.org/sites/default/files/2023-11/ST_SG_AC.10_11_Rev.8e_WEB.pdf | Active Substance Part A (chemicals)2.9: Flammability and self-heatingPPP Part A (chemicals)2.3: Flammability and self-heating |
2.9: Flammability and self-heating (283-A), 2.3: Flammability and self-heating (284-A) | ||||||
| 573 | Method A.9 Flash-point (Annex to Regulation (EC) No 440/2008) | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32008R0440 | Active Substance Part A (chemicals)2.10: Flash pointPPP Part A (chemicals)2.3: Flammability and self-heating |
2.10: Flash point (283-A), 2.3: Flammability and self-heating (284-A) | Only closed cup methods should be used. | |||||
| 574 | Test methods according to Table 2.6.3 of Part 2 of Annex I, Regulation (EC) No 1272/2008 (liquids) | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02008R1272-20231201 | Active Substance Part A (chemicals)2.10: Flash pointPPP Part A (chemicals)2.3: Flammability and self-heating |
2.10: Flash point (283-A), 2.3: Flammability and self-heating (284-A) | ||||||
| 575 | Test methods according to Test series 1-3, Part I of the UN RTDG Manual of Tests and Criteria | Yes | N/A | test method | UN RTDG | https://unece.org/sites/default/files/2023-11/ST_SG_AC.10_11_Rev.8e_WEB.pdf | Active Substance Part A (chemicals)2.11: Explosive propertiesPPP Part A (chemicals)2.2: Explosive and oxidising properties |
2.11: Explosive properties (283-A), 2.2: Explosive and oxidising properties (284-A) | ||||||
| 576 | OECD Test Guideline 115: Surface tension of aqueous solutions | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-115-surface-tension-of-aqueous-solutions_9789264069787-en | Active Substance Part A (chemicals)2.12: Surface tensionPPP Part A (chemicals)2.5: Viscosity and surface tension |
2.12: Surface tension (283-A), 2.5: Viscosity and surface tension (284-A) | ||||||
| 578 | Test O.1: Test for oxidizing solids , Part III of UN RTDG Manual of Tests and Criteria | Yes | N/A | test method | UN RTDG | https://unece.org/sites/default/files/2023-11/ST_SG_AC.10_11_Rev.8e_WEB.pdf | Active Substance Part A (chemicals)2.13: Oxidising propertiesPPP Part A (chemicals)2.2: Explosive and oxidising properties |
2.13: Oxidising properties (283-A), 2.2: Explosive and oxidising properties (284-A) | ||||||
| 579 | Test O.2: Test for oxidizing liquids , Part III of UN RTDG Manual of Tests and Criteria | Yes | N/A | test method | UN RTDG | https://unece.org/sites/default/files/2023-11/ST_SG_AC.10_11_Rev.8e_WEB.pdf | Active Substance Part A (chemicals)2.13: Oxidising propertiesPPP Part A (chemicals)2.2: Explosive and oxidising properties |
2.13: Oxidising properties (283-A), 2.2: Explosive and oxidising properties (284-A) | ||||||
| 581 | EPPO standard PP1/213: Resistance risk analysis | Yes | Yes | guidance document,
test method |
EPPO | https://pp1.eppo.int/standards/PP1-213-4 | Active Substance Part A (chemicals)3.7: Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategiesActive Substance Part B (micro-organisms)3.4: Information on possible development of resistance in the target organism(s) |
3.7: Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies (283-A), 3.4: Information on possible development of resistance in the target organism(s) (283-B) | listed as guidance document in section 3.7 of Communication 283/2013 Part B and as test method in section 3.4 of Communication 283/2013 Part A | |||||
| 582 | OECD Test Guideline 417: Toxicokinetics | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070882-en.pdf?expires=1674491864&id=id&accname=oid031827&checksum=EDB1333FDBF5F2757384A6A59706A602 | Active Substance Part A (chemicals)5.1: Studies on absorption, distribution, metabolism and excretion in mammals |
5.1: Studies on absorption, distribution, metabolism and excretion in mammals (283-A) | ||||||
| 583 | OECD Test Guideline 420: Acute oral toxicity: fixed dose procedure | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-420-acute-oral-toxicity-fixed-dose-procedure_9789264070943-en | Active Substance Part A (chemicals)5.2.1: OralPPP Part A (chemicals)7.1.1: Oral toxicityPPP Part B (micro-organisms)7.3.1: Acute oral toxicity |
5.2.1: Oral (283-A), 7.1.1: Oral toxicity (284-A), 7.3.1: Acute oral toxicity (284-B) | ||||||
| 584 | OECD Test Guideline 423: Acute oral toxicity: acute toxic class method | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-423-acute-oral-toxicity-acute-toxic-class-method_9789264071001-en | Active Substance Part A (chemicals)5.2.1: OralPPP Part A (chemicals)7.1.1: Oral toxicityPPP Part B (micro-organisms)7.3.1: Acute oral toxicity |
5.2.1: Oral (283-A), 7.1.1: Oral toxicity (284-A), 7.3.1: Acute oral toxicity (284-B) | ||||||
| 585 | OECD Test Guideline 425: Acute oral toxicity: up-and-down procedure | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/search?value1=test+no.+425%3A+acute+oral+toxicity%3A+up-and-down+procedure&option1=quicksearch&facetOptions=51&facetNames=pub_igoId_facet&operator51=AND&option51=pub_igoId_facet&value51=%27igo%2Foecd%27&publisherId=%2Fcontent%2Figo%2Foecd&searchType=quick | Active Substance Part A (chemicals)5.2.1: OralPPP Part A (chemicals)7.1.1: Oral toxicity |
5.2.1: Oral (283-A), 7.1.1: Oral toxicity (284-A) | ||||||
| 586 | OECD Test Guideline No 401: Acute oral toxicity | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-401-acute-oral-toxicity_9789264040113-en | Active Substance Part A (chemicals)5.2.1: OralPPP Part A (chemicals)7.1.1: Oral toxicity |
5.2.1: Oral (283-A), 7.1.1: Oral toxicity (284-A) | only acceptable, if performed before December 2002 | |||||
| 587 | OECD Test Guideline 402: Acute Dermal Toxicity | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/fr/environment/test-no-402-acute-dermal-toxicity_9789264070585-en#:~:text=Test%20No.-,402%3A%20Acute%20Dermal%20Toxicity,corrosive%20or%20severely%20irritant%20actions. | Active Substance Part A (chemicals)5.2.2: DermalPPP Part A (chemicals)7.1.2: Dermal toxicityPPP Part B (micro-organisms)7.3.2: Acute dermal toxicity |
5.2.2: Dermal (283-A), 7.1.2: Dermal toxicity (284-A), 7.3.2: Acute dermal toxicity (284-B) | ||||||
| 588 | OECD Test Guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method | Yes | N/A | test method | OECD | https://www.oecd.org/env/test-no-436-acute-inhalation-toxicity-acute-toxic-class-method-9789264076037-en.htm | Active Substance Part A (chemicals)5.2.3: InhalationPPP Part A (chemicals)7.1.3: Inhalation toxicityPPP Part B (micro-organisms)7.3.3: Acute inhalation toxicity |
5.2.3: Inhalation (283-A), 7.1.3: Inhalation toxicity (284-A), 7.3.3: Acute inhalation toxicity (284-B) | ||||||
| 589 | OECD Test Guideline 403: Acute Inhalation Toxicity | Yes | N/A | test method | OECD | https://www.oecd.org/env/test-no-403-acute-inhalation-toxicity-9789264070608-en.htm | Active Substance Part A (chemicals)5.2.3: InhalationPPP Part A (chemicals)7.1.3: Inhalation toxicityPPP Part B (micro-organisms)7.3.3: Acute inhalation toxicity |
5.2.3: Inhalation (283-A), 7.1.3: Inhalation toxicity (284-A), 7.3.3: Acute inhalation toxicity (284-B) | Part A of Communication 283/2013: Existing tests are acceptable, but if new test is to be carried out, preference should be given to OECD Test Guidelines 433 as fewer test animals are needed and/or this method is associated with less severe suffering of the test animals. | |||||
| 591 | OECD Test Guideline 431: In vitro Skin Corrosion: reconstructed human epidermis (RHE) test method | Yes | N/A | test method | OECD | https://www.oecd.org/env/ehs/testing/test-no-431-in-vitro-skin-corrosion-reconstructed-human-epidermis-rhe-test-method-9789264264618-en.htm | Active Substance Part A (chemicals)5.2.4: Skin irritationPPP Part A (chemicals)7.1.4: Skin irritationPPP Part B (micro-organisms)7.3.4: Skin irritation |
5.2.4: Skin irritation (283-A), 7.1.4: Skin irritation (284-A), 7.3.4: Skin irritation (284-B) | ||||||
| 592 | OECD Test Guideline 435: In vitro Membrane Barrier Test Method for Skin Corrosion | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/fr/environment/test-no-435-in-vitro-membrane-barrier-test-method-for-skin-corrosion_9789264242791-en | Active Substance Part A (chemicals)5.2.4: Skin irritationPPP Part A (chemicals)7.1.4: Skin irritationPPP Part B (micro-organisms)7.3.4: Skin irritation |
5.2.4: Skin irritation (283-A), 7.1.4: Skin irritation (284-A), 7.3.4: Skin irritation (284-B) | ||||||
| 593 | OECD Test Guideline 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-439-in-vitro-skin-irritation-reconstructed-human-epidermis-test-method_9789264242845-en | Active Substance Part A (chemicals)5.2.4: Skin irritationPPP Part A (chemicals)7.1.4: Skin irritationPPP Part B (micro-organisms)7.3.4: Skin irritation |
5.2.4: Skin irritation (283-A), 7.1.4: Skin irritation (284-A), 7.3.4: Skin irritation (284-B) | ||||||
| 594 | OECD Test Guideline 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/fr/environment/test-no-430-in-vitro-skin-corrosion-transcutaneous-electrical-resistance-test-method-ter_9789264242739-en | Active Substance Part A (chemicals)5.2.4: Skin irritationPPP Part A (chemicals)7.1.4: Skin irritationPPP Part B (micro-organisms)7.3.4: Skin irritation |
5.2.4: Skin irritation (283-A), 7.1.4: Skin irritation (284-A), 7.3.4: Skin irritation (284-B) | ||||||
| 595 | OECD Test Guideline 404: Acute Dermal Irritation/Corrosion | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264242678-en.pdf?expires=1673877381&id=id&accname=oid031827&checksum=04267461086993273DA32E436EE3D823 | Active Substance Part A (chemicals)5.2.4: Skin irritationPPP Part A (chemicals)7.1.4: Skin irritationPPP Part B (micro-organisms)7.3.4: Skin irritation |
5.2.4: Skin irritation (283-A), 7.1.4: Skin irritation (284-A), 7.3.4: Skin irritation (284-B) | ||||||
| 596 | OECD Test Guideline 492B. Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-492b-reconstructed-human-cornea-like-epithelium-rhce-test-method-for-eye-hazard-identification_0d603916-en | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A) | ||||||
| 597 | OECD Test Guideline 467. Defined Approaches for Serious Eye Damage and Eye Irritation | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-467-defined-approaches-for-serious-eye-damage-and-eye-irritation_28fe2841-en#:~:text=Test%20No.%20467%3A%20Defined%20Approaches%20for%20Serious%20Eye,methods%2C%20with%20information%20sources%20such%20as%20physicochemical%20properties. | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A) | ||||||
| 598 | 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 | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/970e5cd9-en.pdf?expires=1673877123&id=id&accname=oid031827&checksum=4B6B6420E6FE23889D94CDB3D5338C5B | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A) | ||||||
| 599 | OECD Test No. 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9f20068a-en.pdf?expires=1673877340&id=id&accname=guest&checksum=B1E33CF014C9539BB30D8225373F6358 | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A) | ||||||
| 600 | 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 | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264203846-en.pdf?expires=1673877442&id=id&accname=guest&checksum=05102D9F1039A5EB8C2EA9A4AECDFFBC | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritationPPP Part B (micro-organisms)7.3.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A), 7.3.5: Eye irritation (284-B) | ||||||
| 601 | 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 | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264203860-en.pdf?expires=1673877603&id=id&accname=oid031827&checksum=BD6F5ECAD62A7A32AC32DDCCE775E112 | Active Substance Part A (chemicals)5.2.5: Eye irritationPPP Part A (chemicals)7.1.5: Eye irritationPPP Part B (micro-organisms)7.3.5: Eye irritation |
5.2.5: Eye irritation (283-A), 7.1.5: Eye irritation (284-A), 7.3.5: Eye irritation (284-B) | ||||||
| 626 | OECD 470 Test Guideline on the Mammalian Erythrocyte Pig-a Gene Mutation Assay | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/4faea90e-en.pdf?expires=1673878856&id=id&accname=guest&checksum=9D0485DFBEA60AC9F27BA83589120F06 | Active Substance Part A (chemicals)5.4.2: In vivo studies in somatic cells |
5.4.2: In vivo studies in somatic cells (283-A) | The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested | |||||
| 627 | OECD Test Guideline 474: Mammalian Erythrocyte Micronucleus Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-474-mammalian-erythrocyte-micronucleus-test_9789264264762-en | Active Substance Part A (chemicals)5.4.2: In vivo studies in somatic cells |
5.4.2: In vivo studies in somatic cells (283-A) | The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested | |||||
| 491 | Scientific Opinion on the effect assessment for pesticides on sediment organisms in edge-of-field surface water´ (EFSA Journal 2015;13(7):4176) | No | N/A | supporting document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4176 | ||||||||
| 493 | Cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system (EFSA, 2020) | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/6087 | ||||||||
| 494 | Comparison of cumulative dietary exposure to pesticide residues for the reference periods 2014–2016 and 2016–2018 | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/6394 | ||||||||
| 495 | Potential impact of prioritisation methods on the outcome of cumulative exposure assessments of pesticides (EFSA, 2021) | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/supporting/pub/en-6559 | ||||||||
| 497 | ECHA Practical Guide – how to use and report (Q)SARs | Yes | Yes | guidance document | ECHA | https://echa.europa.eu/documents/10162/13655/pg_report_qsars_en.pdf/407dff11-aa4a-4eef-a1ce-9300f8460099 | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 498 | De Jong et al (2006): Guidance for summarizing earthworm field studies. RIVM report No 601506006/2006 | Yes | Yes | guidance document | RIVM | https://www.rivm.nl/bibliotheek/rapporten/601506006.pdf | Active Substance Part A (chemicals)8.4: Effects on non-target soil meso- and macrofaunaPPP Part A (chemicals)10.4.1.2: Earthworms — field studies |
8.4: Effects on non-target soil meso- and macrofauna (283-A), 10.4.1.2: Earthworms — field studies (284-A) | ||||||
| 499 | OECD (2018) Adverse Outcome Pathway on Androgen receptor agonism leading to reproductive dysfunction (in repeat-spawning fish) OECD Series on Adverse Outcome Pathways, No. 9, OECD Publishing, Paris. | No | N/A | supporting document | OECD | http://dx.doi.org/10.1787/b0c6838a-en | ||||||||
| 500 |
OECD (2016) Report of Pre-validation and Inter-laboratory Validation Studies For Androgen Receptor (AR) Mediated Stably Transfected Transcriptional Activation (AR-STTA) Assay to Detect Androgenic and Antiandrogenic Activities of Chemicals: AR EcoScreenTM Series on Testing & Assessment No. 241 ENV/JM/MONO(2016)36
|
No | N/A | supporting document | OECD | |||||||||
| 501 | OECD (2016) Report of the validation of the (anti-) ERα CALUX bioassay: U2-OS cells Transcriptional ERalpha CALUX- assay for the detection of estrogenic and anti-estrogenic chemicals for inclusion in TG455 Series on Testing & Assessment No. 240 ENV/JM/MONO(2016)35 | No | N/A | supporting document | OECD | https://one.oecd.org/document/ENV/JM/MONO(2016)35/en/pdf | ||||||||
| 502 | OECD (2015) GUIDANCE DOCUMENT ON HISTOPATHOLOGY TECHNIQUES AND EVALUATION (PART 1) FOR THE LARVAL AMPHIBIAN GROWTH AND DEVELOPMENT ASSAY (LAGDA) Series on Testing & Assessment No. 228 ENV/JM/MONO(2015)37/PART1 | No | N/A | supporting document | OECD | https://web-archive.oecd.org/2015-11-24/379259-37_PART1.pdf | ||||||||
| 503 | OECD (2015) INTEGRATED SUMMARY REPORT: Validation of Two Binding Assays Using Human Recombinant Estrogen Receptor Alpha (hrERa) Series on Testing & Assessment No. 226 ENV/JM/MONO(2015)35 | No | N/A | supporting document | OECD | https://web-archive.oecd.org/2015-11-24/379272-MONO(2015)35.pdf | ||||||||
| 504 | OECD (2015) REPORT OF THE INTER-LABORATORY VALIDATION FOR STABLY TRANSFECTED TRANSACTIVATION ASSAY TO DETECT ESTROGENIC AND ANTI-ESTROGENIC ACTIVITY Series on Testing & Assessment No. 225 Unclassified ENV/JM/MONO(2015)34 | No | N/A | supporting document | OECD | https://web-archive.oecd.org/2015-11-24/379271-MONO(2015)34.pdf | ||||||||
| 505 | OECD (2015) PERFORMANCE STANDARDS FOR THE HUMAN RECOMBINANT ESTROGEN RECEPTOR BINDING ASSAY (INTENDED FOR THE DEVELOPERS OF NEW OR MODIFIED SIMILAR TEST METHODS) Series on Testing & Assessment No. 222 ENV/JM/MONO(2015)29 | No | N/A | supporting document | OECD | https://one.oecd.org/document/ENV/JM/MONO(2015)29/en/pdf | ||||||||
| 506 | OECD (2014) NEW SCOPING DOCUMENT ON IN VITRO AND EX VIVO ASSAYS FOR THE IDENTIFICATION OF MODULATORS OF THYROID HORMONE SIGNALLING Series on Testing and Assessment No. 207 ENV/JM/MONO(2014)23 | No | N/A | supporting document | OECD | https://one.oecd.org/document/ENV/JM/MONO(2014)23/en/pdf | ||||||||
| 507 | OECD (2012) DETAILED REVIEW PAPER ON THE STATE OF THE SCIENCE ON NOVEL IN VITRO AND IN VIVO SCREENING AND TESTING METHODS AND ENDPOINTS FOR EVALUATING ENDOCRINE DISRUPTORS Series on Testing & Assessment No. 178 ENV/JM/MONO(2012)23 | No | N/A | supporting document | OECD | https://one.oecd.org/document/env/jm/mono(2012)23/en/pdf | ||||||||
| 509 | OECD (2012) PERFORMANCE STANDARDS FOR STABLY TRANSFECTED TRANSACTIVATION IN VITRO ASSAYS TO DETECT ESTROGEN AGONISTS FOR TG 455 Series on Testing and Assessment No. 173 ENV/JM/MONO(2012)18 | No | N/A | supporting document | OECD | https://one.oecd.org/document/env/jm/mono(2012)18/en/pdf | ||||||||
| 511 | EFSA (2014). Scientific Opinion on good modelling practice in the context of mechanistic effect models for risk assessment of plant protection products (Accessed Nov 2018). | No | N/A | supporting document | EFSA | http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3589/abstract | ||||||||
| 513 | Outcome of the pesticides peer review meeting on general recurring issues in physical and chemical properties and analytical methods. | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/supporting/pub/en-1221 | ||||||||
| 515 | OECD Guidance Document for the Derivation of an Acute Reference Concentration (Arfc). Series on Testing and Assessment, No. 153 | Yes | Yes | guidance document | OECD | https://web-archive.oecd.org/2012-06-14/93080-48542016.pdf | Active Substance Part A (chemicals)5.2.3: InhalationPPP Part A (chemicals)7.1.3: Inhalation toxicity |
5.2.3: Inhalation (283-A), 7.1.3: Inhalation toxicity (284-A) | ||||||
| 516 | OECD Overview of the set of OECD Genetic Toxicology test methods and updates performed in 2014-2015. Series on Testing & Assessment. No. 238 - 2nd edition. Published 22 August 2017. | No | N/A | supporting document | OECD | https://one.oecd.org/document/ENV/JM/MONO(2016)33/REV1/en/pdf | ||||||||
| 518 | EFSA supporting publication 2019. Evaluation of the applicability of existing (Q)SAR models for predicting the genotoxicity of pesticides and similarity analysis related with genotoxicity of pesticides for facilitating of grouping and read across. EN-1598 | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/supporting/pub/en-1598 | ||||||||
| 520 | ECHA, 2008. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R6. | No | N/A | supporting document | ECHA | https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment | ||||||||
| 521 | EFSA Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Journal 2019;17(6):5708) | Yes | Yes | guidance document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/5708 | Active Substance Part A (chemicals)0: General GuidanceActive Substance Part B (micro-organisms)5.5: Information and toxicity studies on metabolites6.1: Estimation of consumer exposure to residues PPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 5.5: Information and toxicity studies on metabolites (283-B), 6.1: Estimation of consumer exposure to residues (283-B), 0: General Guidance (284-A) | ||||||
| 522 | 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) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6768 | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 523 | 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) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6970 | Active Substance Part A (chemicals)5.1: Studies on absorption, distribution, metabolism and excretion in mammals |
5.1: Studies on absorption, distribution, metabolism and excretion in mammals (283-A) | ||||||
| 524 | EFSA. Development of Integrated Approaches to Testing and Assessment (IATA) case studies on developmental neurotoxicity (DNT) risk assessment. 2021, EFSA Journal 2021;19(6):6599 | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/6599 | ||||||||
| 525 | Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments, EFSA Journal 2021;19(10):6877 | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/6877 | ||||||||
| 528 | Regulation (EC) No 1107/2009 – Scope and borderline issues (SANCO Doc 6621-99) | No | N/A | supporting document | SANTE | https://food.ec.europa.eu/document/download/0a630eff-9622-4f24-916c-33ead41e6724_en?filename=pesticides_ppp_app-proc_guide_scope_reg-1107-2019_1.pdf | ||||||||
| 532 | Guidance document on preparing list of test and study reports according to Article 60 of Regulation (EC) No 1107/2009 (SANCO/12580/2012) | No | Yes | guidance document | SANTE | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/document/download/40b9280f-9746-4515-9d0b-70940b343af1_en?filename=pesticides_ppp_app-proc_guide_doss_12580.pdf | |||||||
| 533 | Guidance document on rules for revision of assessment reports (SANCO/10180/2013) | No | Yes | guidance document | SANTE | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/document/download/b1ebcff8-d728-494d-ba87-bd4ee42cd979_en?filename=pesticides_ppp_app-proc_guide_doss_rules-for-revision.pdf | |||||||
| 534 | Combined Template to be used for Assessment Reports according to Regulation (EC) No 1107/2009 and Proposals for Harmonised Classification and Labelling according to Regulation (EC) No 1272/2008 (SANCO/12592/2012) | No | N/A | guidance document | SANTE | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/document/download/5a067575-40fa-4fb3-93f1-640d0a8a6984_en?filename=pesticides_ppp_app-proc_guide_doss_12592-2012.zip | cover page is available: https://food.ec.europa.eu/document/download/ce98e221-65dc-4014-902b-d0d96a68b65a_en?filename=pesticides_ppp_app-proc_guide_doss_12592-2012.pdf | ||||||
| 537 | Terms of reference of the Working Group on Post Approval Issues from the Standing Committee on Animals, Plants, Food and Feed (SANTE-11102-2017) | No | N/A | supporting document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/system/files/2021-01/pesticides_aas_notification_tor-wg.pdf | |||||||
| 538 | Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009 (SANCO/13170/2010) | No | Yes | guidance document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/system/files/2016-11/pesticides_aas_guidance_renewal_1107-2009.pdf | |||||||
| 539 | Guidance document on Comparative Assessment and Substitution of Plant Protection Products in accordance with Regulation (EC) No 1107/2009 (SANCO/11507/2013) | No | No | guidance document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/document/download/be440357-ae1f-4e57-8ca7-3690f50c08cf_en?filename=pesticides_aas_guidance_comparative_assessment_substitution_rev_1107-2009.pdf | |||||||
| 540 | Guidance on emergency authorisations according to Article 53 (under review) | No | No | guidance document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/document/download/1b2f26fc-59bd-465d-976e-0f1c366bafc8_en?filename=pesticides_aas_guidance_wd_emergency_authorisations_article53_post-210301.pdf | |||||||
| 541 | Working document on emergency authorisations according to Article 53 (SANCO/10087/2013) - for application submitted before 1 March 2021 | No | Yes | guidance document | COM | Procedural guidance document- post approval issues | https://food.ec.europa.eu/system/files/2016-10/pesticides_aas_guidance_wd_emergency_authorisations_article53_en.pdf | |||||||
| 542 | OECD Guidance Document on Good In Vitro Method Practices (GIVIMP) | Yes | Yes | guidance document | OECD | https://www.oecd-ilibrary.org/environment/guidance-document-on-good-in-vitro-method-practices-givimp/reporting-of-results_9789264304796-14-en#:~:text=Key%20message%3A%20Good%20reporting%20of%20in%20vitro%20methods,improve%20the%20method%20and%20the%20rational%20for%20them. | Active Substance Part A (chemicals)0: General GuidanceActive Substance Part B (micro-organisms)0: General GuidancePPP Part A (chemicals)0: General GuidancePPP Part B (micro-organisms)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (283-B), 0: General Guidance (284-A), 0: General Guidance (284-B) | Series on Testing and Assessment, No. 286. | |||||
| 543 | Guidance document on the Interpretation of the Transitional Measures for the Data Requirements for active substances and plant protection products according to Regulation (EU) No 283/2013 and Regulation (EU) No 284/2013 (SANTE/11509 /2013) | No | Yes | guidance document | SANTE | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/document/download/f71328a4-3734-4b33-9272-743f3985bb63_en?filename=pesticides_ppp_app-proc_guide_doss_new-data-req_rev-3.pdf | |||||||
| 544 | Comparison list A (chemicals) - Annex II and Annex III points (OECD vs. former EC system) | No | N/A | supporting document | SANTE | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_doss_comparison-list_chem.pdf | |||||||
| 545 | Comparison list B (microbials) - Annex II and Annex III points (OECD vs. former EC system) | No | N/A | supporting document | SANTE | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_doss_comparison-list_micros.pdf | |||||||
| 607 | OECD Test Guideline 429: Skin Sensitisation – Local Lymph Node Assay | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264071100-en.pdf?expires=1673878093&id=id&accname=ocid194935&checksum=0CDF573D616D505C955642D4F4515F4E | Active Substance Part A (chemicals)5.2.6: Skin sensitisationPPP Part A (chemicals)7.1.6: Skin sensitisationPPP Part B (micro-organisms)7.3.6: Skin sensitisation |
5.2.6: Skin sensitisation (283-A), 7.1.6: Skin sensitisation (284-A), 7.3.6: Skin sensitisation (284-B) | ||||||
| 608 | OECD Test Guideline 406: Skin sensitisation | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070660-en.pdf?expires=1673878098&id=id&accname=guest&checksum=CF9D0DCD2239103D69700957CAE02F28 | Active Substance Part A (chemicals)5.2.6: Skin sensitisationPPP Part A (chemicals)7.1.6: Skin sensitisationPPP Part B (micro-organisms)7.3.6: Skin sensitisation |
5.2.6: Skin sensitisation (283-A), 7.1.6: Skin sensitisation (284-A), 7.3.6: Skin sensitisation (284-B) | As the Buehler test is considered less sensitive than the maximization test, there is a preference of choice of assay for the maximisation test | |||||
| 609 | OECD Test Guideline 442A: Skin Sensitisation – Local Lymph Node Assay: DA | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264090972-en.pdf?expires=1673878196&id=id&accname=ocid194935&checksum=9F82C29941D8FF864CCFACE418E40647 | Active Substance Part A (chemicals)5.2.6: Skin sensitisationPPP Part A (chemicals)7.1.6: Skin sensitisationPPP Part B (micro-organisms)7.3.6: Skin sensitisation |
5.2.6: Skin sensitisation (283-A), 7.1.6: Skin sensitisation (284-A), 7.3.6: Skin sensitisation (284-B) | ||||||
| 611 | OECD Test Guideline 432: In vitro 3T3 NRU Phototoxicity Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-432-in-vitro-3t3-nru-phototoxicity-test_9789264071162-en | Active Substance Part A (chemicals)5.2.7: Phototoxicity |
5.2.7: Phototoxicity (283-A) | ||||||
| 612 | OECD Test No. 498: In vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity test method | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/7b2f9ea0-en.pdf?expires=1673878244&id=id&accname=guest&checksum=6AD7C8FD762D5F60EBCDEC717B8E537E | Active Substance Part A (chemicals)5.2.7: Phototoxicity |
5.2.7: Phototoxicity (283-A) | ||||||
| 613 | OECD Test Guideline 422: Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-422-combined-repeated-dose-toxicity-study-with-the-reproduction-developmental-toxicity-screening-test_9789264264403-en | Active Substance Part A (chemicals)5.3: Short-term toxicity |
5.3: Short-term toxicity (283-A) | ||||||
| 614 | OECD Test Guideline 407: Repeated dose 28-day oral toxicity study in rodents | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070684-en.pdf?expires=1673878306&id=id&accname=ocid194935&checksum=920578B1C7655F9A1E0EB86706A8B148 | Active Substance Part A (chemicals)5.3.1: Oral 28-day study |
5.3.1: Oral 28-day study (283-A) | According to Regulation (EU) No 283/2013 in conjunction with Article 62(1) of Regulation (EC) No 1107/2009, this study shall not be generated for an application but should only be submitted if available. | |||||
| 615 | OECD Test Guideline 408: Repeated dose 90-day oral toxicity study in rodents | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-408-repeated-dose-90-day-oral-toxicity-study-in-rodents_9789264070707-en | Active Substance Part A (chemicals)5.3.2: Oral 90-day study |
5.3.2: Oral 90-day study (283-A) | ||||||
| 616 | OECD Test Guideline 409: Repeated dose 90-day oral toxicity study in non-rodents | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-409-repeated-dose-90-day-oral-toxicity-study-in-non-rodents_9789264070721-en | Active Substance Part A (chemicals)5.3.2: Oral 90-day study |
5.3.2: Oral 90-day study (283-A) | ||||||
| 617 | OECD Test Guideline 410: Repeated dose dermal toxicity: 21/28-day study | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070745-en.pdf?expires=1673878392&id=id&accname=ocid194935&checksum=4157533FFC567AD78E45E984816F3961 | Active Substance Part A (chemicals)5.3.3: Other routes |
5.3.3: Other routes (283-A) | According to Regulation (EU) No 283/2013 in conjunction with Article 62(1) of Regulation (EC) No 1107/2009, this study shall only be submitted if experts judge it necessary. | |||||
| 618 | OECD Test Guideline 411: Subchronic dermal toxicity: 90-day study | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-411-subchronic-dermal-toxicity-90-day-study_9789264070769-en | Active Substance Part A (chemicals)5.3.3: Other routes |
5.3.3: Other routes (283-A) | ||||||
| 619 | OECD Test Guideline 412: Subacute inhalation toxicity: 28-day study | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-412-subacute-inhalation-toxicity-28-day-study_9789264070783-en | Active Substance Part A (chemicals)5.3.3: Other routes |
5.3.3: Other routes (283-A) | According to Regulation (EU) No 283/2013 in conjunction of Article 62(1) of Regulation (EC) No 1107/2009, this study shall not be generated for an application but should only be submitted if available. | |||||
| 620 | OECD Test Guideline 413: Subchronic inhalation toxicity: 90-day study | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-413-subchronic-inhalation-toxicity-90-day-study_9789264070806-en | Active Substance Part A (chemicals)5.3.3: Other routes |
5.3.3: Other routes (283-A) | According to Regulation (EU) No 283/2013 in conjunction of Article 62(1) of Regulation (EC) No 1107/2009, this study shall only be submitted if experts judge it necessary. | |||||
| 621 | OECD Test Guideline 471: Bacterial Reverse Mutation Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264071247-en.pdf?expires=1673878746&id=id&accname=guest&checksum=1884BBD2396CD74D94C95FC6AB49349B | Active Substance Part A (chemicals)5.4.1: In vitro studies |
5.4.1: In vitro studies (283-A) | ||||||
| 622 | OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264861-en.pdf?expires=1673878768&id=id&accname=oid031827&checksum=AB84D30B00BBCDD74C8AD185F7A00A1F | Active Substance Part A (chemicals)5.4.1: In vitro studies |
5.4.1: In vitro studies (283-A) | ||||||
| 623 | OECD Test Guideline 473: In vitro Mammalian Chromosome Aberration Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-473-in-vitro-mammalian-chromosomal-aberration-test_9789264264649-en | Active Substance Part A (chemicals)5.4.1: In vitro studies |
5.4.1: In vitro studies (283-A) | ||||||
| 624 | OECD Test Guideline 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264809-en.pdf?expires=1673878818&id=id&accname=oid031827&checksum=3B62E8329C32A3EE8FE620BBF96187C8 | Active Substance Part A (chemicals)5.4.1: In vitro studies |
5.4.1: In vitro studies (283-A) | ||||||
| 625 | OECD Test Guideline 490: In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264908-en.pdf?expires=1673878835&id=id&accname=oid031827&checksum=E5DF137CEBEC77D2859C24B01728AC0E | Active Substance Part A (chemicals)5.4.1: In vitro studies |
5.4.1: In vitro studies (283-A) | ||||||
| 434 | 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) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5655 | PPP Part B (micro-organisms)8: Residues in or on treated products, food and feed |
8: Residues in or on treated products, food and feed (284-B) | ||||||
| 436 | Protocol for the evaluation of data concerning the necessity of the application of insecticide active substances to control a serious danger to plant health which cannot be contained by other available means, including non-chemical methods | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/supporting/pub/en-1201 | ||||||||
| 645 | 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 | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264304741-en.pdf?expires=1675352787&id=id&accname=oid031827&checksum=C644AB9D07B893EBC910D4E12A40DED3 | Active Substance Part A (chemicals)5.8.3: Endocrine disrupting properties |
5.8.3: Endocrine disrupting properties (283-A) | Tests should be conducted as appropriate in order to elucidate a possible endocrine mode of action following the EFSA/ECHA guidance. Where sufficient weight of evidence to conclude on the presence or absence of a particular endocrine disrupting mode of action is available: — further testing on vertebrate animals for that effect shall be omitted for that mode of action, — further testing not involving vertebrate animals may be omitted for that mode of action. For OECD 443, check requirements under notes in 5.6.1.Generational studies | |||||
| 807 | 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. | Yes | Yes | guidance document | EPPO | https://pp1.eppo.int/standards/general | PPP Part B (micro-organisms)6: Efficacy data |
6: Efficacy data (284-B) | ||||||
| 808 | EPPO PP1/207 Effects on succeeding crops | Yes | Yes | guidance document | EPPO | https://pp1.eppo.int/standards/PP1-207-2 | PPP Part B (micro-organisms)6.6.1: Impact on succeeding crops |
6.6.1: Impact on succeeding crops (284-B) | ||||||
| 809 | EPPO PP1/256 Effects on adjacent crops | Yes | Yes | guidance document | EPPO | https://pp1.eppo.int/standards/PP1-256-1 | PPP Part B (micro-organisms)6.6.2: Impact on other plants, including adjacent crops |
6.6.2: Impact on other plants, including adjacent crops (284-B) | ||||||
| 811 | OECD Guideline No. 497: Defined Approaches on Skin Sensitisation | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/b92879a4-en.pdf?expires=1674482759&id=id&accname=guest&checksum=EAFE26B5409FD6DC1799F5819FB3B8A4 | PPP Part B (micro-organisms)7.3.6: Skin sensitisation |
7.3.6: Skin sensitisation (284-B) | ||||||
| 812 | EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/document/download/ffdf09b5-77a5-45b5-95f9-b16272f7535a_en?filename=pesticides_ppp_app-proc_guide_180653_microorganism-metabolites-concern.pdf | Active Substance Part B (micro-organisms)2.8: Information on metabolites of concernPPP Part B (micro-organisms)7.5: Data on exposure8: Residues in or on treated products, food and feed 10: Effects on non-target organisms |
2.8: Information on metabolites of concern (283-B), 7.5: Data on exposure (284-B), 8: Residues in or on treated products, food and feed (284-B), 10: Effects on non-target organisms (284-B) | ||||||
| 813 | EFSA Guidance on dermal absorption (EFSA Journal 2017;15(6):4873) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4873 | https://food.ec.europa.eu/document/download/a7a59c8a-5539-429a-9f93-a434882a726f_en?filename=pesticides_ppp_app-proc_guide_tox_dermal-absorp-2018-paff.pdf | PPP Part B (micro-organisms)7.5: Data on exposure |
7.5: Data on exposure (284-B) | |||||
| 814 | FAO Operator exposure models and local risk assessment | Yes | Yes | guidance document | FAO | https://www.fao.org/pesticide-registration-toolkit/registration-tools/assessment-methods/method-detail/en/c/1187029/ | PPP Part B (micro-organisms)7.5: Data on exposure |
7.5: Data on exposure (284-B) | ||||||
| 815 |
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.
|
Yes | No | PPP Part B (micro-organisms)10: Effects on non-target organisms |
10: Effects on non-target organisms (284-B) | |||||||||
| 816 | OECD Guidance to the environmental safety evaluation of microbial biocontrol agents, Series on Pesticides No. 67 (ENV/JM/MONO(2012)1) | Yes | Yes | guidance document | OECD | https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2012)1&doclanguage=en | PPP Part B (micro-organisms)10: Effects on non-target organisms |
10: Effects on non-target organisms (284-B) | ||||||
| 818 | 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) | Yes | Yes | guidance document | CANADA | https://publications.gc.ca/collections/collection_2017/eccc/En49-7-1-44-2016-eng.pdf | Active Substance Part B (micro-organisms)8: Ecotoxicological studies |
8: Ecotoxicological studies (283-B) | ||||||
| 819 | 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 | Yes | Yes | guidance document,
test method |
CANADA | https://publications.gc.ca/collections/collection_2017/eccc/En49-7-1-44-2016-eng.pdf | Active Substance Part B (micro-organisms)8.1: Effects on terrestrial vertebrates |
8.1: Effects on terrestrial vertebrates (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 820 | 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 | Yes | Yes | guidance document,
test method |
CANADA | https://publications.gc.ca/collections/collection_2017/eccc/En49-7-1-44-2016-eng.pdf | Active Substance Part B (micro-organisms)8.1: Effects on terrestrial vertebrates |
8.1: Effects on terrestrial vertebrates (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 823 | 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 | Yes | Yes | guidance document,
test method |
CANADA | https://publications.gc.ca/collections/collection_2017/eccc/En49-7-1-44-2016-eng.pdf | Active Substance Part B (micro-organisms)8.3: Effects on bees |
8.3: Effects on bees (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 825 | 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 | Yes | Yes | guidance document,
test method |
CANADA | https://publications.gc.ca/collections/collection_2017/eccc/En49-7-1-44-2016-eng.pdf | Active Substance Part B (micro-organisms)8.5: Effects on non-target meso- and macro-organisms in soil |
8.5: Effects on non-target meso- and macro-organisms in soil (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 646 | OECD Test Guideline 506: Stability of Pesticide Residues in Stored Commodities | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264061927-en.pdf?expires=1673880228&id=id&accname=ocid194935&checksum=06F9034864AE8ED42BE56E31335DD7CE | Active Substance Part A (chemicals)6.1: Storage stability of residues |
6.1: Storage stability of residues (283-A) | ||||||
| 647 | OECD Test Guideline 501: Metabolism in crops | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-501-metabolism-in-crops_9789264061835-en | Active Substance Part A (chemicals)6.2.1: Plants |
6.2.1: Plants (283-A) | ||||||
| 648 | OECD Test Guideline 503: Metabolism in livestock | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-503-metabolism-in-livestock_9789264061873-en | Active Substance Part A (chemicals)6.2.2: Poultry6.2.3: Lactating ruminants 6.2.4: Pigs |
6.2.2: Poultry (283-A), 6.2.3: Lactating ruminants (283-A), 6.2.4: Pigs (283-A) | ||||||
| 649 | OECD Test Guideline 509: Crop field trials | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264076457-en.pdf?expires=1673880288&id=id&accname=guest&checksum=3512175DCEF61DB312C50594ECF04F60 | Active Substance Part A (chemicals)6.3: Magnitude of residue trials in plants6.5.2: Distribution of the residue in inedible peel and pulp 6.6.2: Magnitude of residues in rotational crops |
6.3: Magnitude of residue trials in plants (283-A), 6.5.2: Distribution of the residue in inedible peel and pulp (283-A), 6.6.2: Magnitude of residues in rotational crops (283-A) | ||||||
| 650 | OECD Test Guideline 505: Residues in livestock. | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264061903-en.pdf?expires=1673880475&id=id&accname=ocid194935&checksum=C0292BB6F944BEAF00B645142CF2E20D | Active Substance Part A (chemicals)6.4.1: Poultry6.4.2: Ruminants 6.4.3: Pigs |
6.4.1: Poultry (283-A), 6.4.2: Ruminants (283-A), 6.4.3: Pigs (283-A) | ||||||
| 651 | OECD Test Guideline 507: Nature of the pesticide residues in processed commodities – High temperature hydrolysis. | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264067431-en.pdf?expires=1673880496&id=id&accname=ocid194935&checksum=593AEF7CA5AFF10095400701B6D8005A | Active Substance Part A (chemicals)6.5.1: Nature of the residue |
6.5.1: Nature of the residue (283-A) | ||||||
| 652 | OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264067622-en.pdf?expires=1673880513&id=id&accname=ocid194935&checksum=D6B3FD29F5CD2387FA452385BF8E8C80 | Active Substance Part A (chemicals)6.5.2: Distribution of the residue in inedible peel and pulp6.5.3: Magnitude of residues in processed commodities |
6.5.2: Distribution of the residue in inedible peel and pulp (283-A), 6.5.3: Magnitude of residues in processed commodities (283-A) | ||||||
| 653 | OECD Test Guideline 502: Metabolism in rotational crops. | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-502-metabolism-in-rotational-crops_9789264061859-en | Active Substance Part A (chemicals)6.6.1: Metabolism in rotational crops |
6.6.1: Metabolism in rotational crops (283-A) | ||||||
| 654 | OECD Test Guideline 504: Residues in rotational crops (limited field studies) | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264013384-en.pdf?expires=1673880556&id=id&accname=ocid194935&checksum=FFEB8F1C26526CFACBE59349A52837BC | Active Substance Part A (chemicals)6.6.2: Magnitude of residues in rotational crops |
6.6.2: Magnitude of residues in rotational crops (283-A) | ||||||
| 655 | OECD Test Guideline 307: Aerobic and anaerobic transformation in soil | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070509-en.pdf?expires=1673880752&id=id&accname=ocid194935&checksum=69C5A2221801C4D6C4FBDD9354EAB9B1 | Active Substance Part A (chemicals)7.1: Fate and behaviour in soil7.1.1.1: Aerobic degradation 7.1.1.2: Anaerobic degradation 7.1.2.1: Laboratory studies PPP Part A (chemicals)9.1: Fate and behaviour in soil9.1.1.1: Laboratory studies 9.1.2.1: Laboratory studies |
7.1: Fate and behaviour in soil (283-A), 7.1.1.1: Aerobic degradation (283-A), 7.1.1.2: Anaerobic degradation (283-A), 7.1.2.1: Laboratory studies (283-A), 9.1: Fate and behaviour in soil (284-A), 9.1.1.1: Laboratory studies (284-A), 9.1.2.1: Laboratory studies (284-A) | ||||||
| 656 |
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
|
Yes | N/A | test method | - | Active Substance Part A (chemicals)7.1: Fate and behaviour in soilPPP Part A (chemicals)9.1: Fate and behaviour in soil |
7.1: Fate and behaviour in soil (283-A), 9.1: Fate and behaviour in soil (284-A) | Test carried out until the date of publication of this Communication still valid, however new test shall be carried out in accordance with ISO 18400 | ||||||
| 657 | ISO 18400-206:2018 | Yes | N/A | test method | ISO | https://www.iso.org/standard/68249.html | Active Substance Part A (chemicals)7.1: Fate and behaviour in soilPPP Part A (chemicals)9.1: Fate and behaviour in soil |
7.1: Fate and behaviour in soil (283-A), 9.1: Fate and behaviour in soil (284-A) | ||||||
| 658 | US EPA Test Guideline OPPTS 835.2410 Photodegradation on Soil. EPA 712-C-08-015, October 2008 | Yes | N/A | test method | EPA | https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0152-0015 | Active Substance Part A (chemicals)7.1.1.3: Soil photolysis |
7.1.1.3: Soil photolysis (283-A) | ||||||
| 659 | OECD Test Guideline 106: Adsorption - Desorption Using a Batch Equilibrium Method | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264069602-en.pdf?expires=1673882841&id=id&accname=ocid194935&checksum=899FA2B2CB8CE5C548585E005409A76C | Active Substance Part A (chemicals)7.1.3.1: Adsorption and desorptionPPP Part A (chemicals)9.1.2.1: Laboratory studies |
7.1.3.1: Adsorption and desorption (283-A), 9.1.2.1: Laboratory studies (284-A) | ||||||
| 660 | OECD Test Guideline 121: Estimation of the Adsorption Coefficient (Koc ) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC) | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264069909-en.pdf?expires=1673882913&id=id&accname=ocid194935&checksum=FDF50A41DC25E136E7085C7DA2BB4519 | Active Substance Part A (chemicals)7.1.3.1: Adsorption and desorptionPPP Part A (chemicals)9.1.2.1: Laboratory studies |
7.1.3.1: Adsorption and desorption (283-A), 9.1.2.1: Laboratory studies (284-A) | ||||||
| 661 | OECD Test Guideline 312: Leaching in Soil Columns | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070561-en.pdf?expires=1673883046&id=id&accname=ocid194935&checksum=486143E834314921A4E3E4E7C737CEEA | Active Substance Part A (chemicals)7.1.4.1: Column leaching studiesPPP Part A (chemicals)9.1.2.1: Laboratory studies |
7.1.4.1: Column leaching studies (283-A), 9.1.2.1: Laboratory studies (284-A) | ||||||
| 662 | OECD Guidance Document for the Performance Of Out-door Monolith Lysimeter Studies. Series on Testing and Assessment, No. 22 | Yes | N/A | test method | OECD | https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2000)8&doclanguage=en | Active Substance Part A (chemicals)7.1.4.2: Lysimeter studiesPPP Part A (chemicals)9.1.2.2: Lysimeter studies |
7.1.4.2: Lysimeter studies (283-A), 9.1.2.2: Lysimeter studies (284-A) | ||||||
| 663 | OECD Test Guideline 111: Hydrolysis as a Function of pH | Yes | N/A | test method | OECD | https://read.oecd-ilibrary.org/environment/test-no-111-hydrolysis-as-a-function-of-ph_9789264069701-en#page1 | Active Substance Part A (chemicals)7.2.1.1: Hydrolytic degradation |
7.2.1.1: Hydrolytic degradation (283-A) | ||||||
| 664 | OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis | Yes | N/A | test method | OECD | https://read.oecd-ilibrary.org/environment/test-no-316-phototransformation-of-chemicals-in-water-direct-photolysis_9789264067585-en#page1 | Active Substance Part A (chemicals)7.2.1.2: Direct photochemical degradation |
7.2.1.2: Direct photochemical degradation (283-A) | ||||||
| 665 | OECD Guideline Test 301: Ready Biodegradability (301 A - F) | Yes | N/A | test method | OECD | https://read.oecd-ilibrary.org/environment/test-no-301-ready-biodegradability_9789264070349-en#page1 | Active Substance Part A (chemicals)7.2.2.1: ‘Ready biodegradability’ |
7.2.2.1: ‘Ready biodegradability’ (283-A) | ||||||
| 666 | OECD Test Guideline 310: Ready Biodegradability - CO2 in sealed vessels (Headspace Test) | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264224506-en.pdf?expires=1673883337&id=id&accname=oid031827&checksum=3174D7F5931BF220CC834DC5BA1772AF | Active Substance Part A (chemicals)7.2.2.1: ‘Ready biodegradability’ |
7.2.2.1: ‘Ready biodegradability’ (283-A) | ||||||
| 667 | OECD Test Guideline 309: Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test | Yes | N/A | test method | OECD | https://read.oecd-ilibrary.org/environment/test-no-309-aerobic-mineralisation-in-surface-water-simulation-biodegradation-test_9789264070547-en#page1 | Active Substance Part A (chemicals)7.2.2.2: Aerobic mineralisation in surface waterPPP Part A (chemicals)9.2.1: Aerobic mineralisation in surface water |
7.2.2.2: Aerobic mineralisation in surface water (283-A), 9.2.1: Aerobic mineralisation in surface water (284-A) | ||||||
| 668 | OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070523-en.pdf?expires=1673883376&id=id&accname=ocid194935&checksum=FBFCE55A55D34F5C520920F7AB0FF122 | Active Substance Part A (chemicals)7.2.2.3: Water/sediment study7.2.2.4: Irradiated water/sediment study PPP Part A (chemicals)9.2.2: Water/sediment study9.2.3: Irradiated water/sediment study |
7.2.2.3: Water/sediment study (283-A), 7.2.2.4: Irradiated water/sediment study (283-A), 9.2.2: Water/sediment study (284-A), 9.2.3: Irradiated water/sediment study (284-A) | ||||||
| 669 | OECD Test Guideline No 223: Avian acute oral toxicity study | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264519-en.pdf?expires=1673883622&id=id&accname=oid031827&checksum=193A9B83729E3B0CEFF16DDD28D7DBD0 | Active Substance Part A (chemicals)8.1.1.1: Acute oral toxicity to birdsPPP Part A (chemicals)10.1.1.1: Acute oral toxicity to birds |
8.1.1.1: Acute oral toxicity to birds (283-A), 10.1.1.1: Acute oral toxicity to birds (284-A) | ||||||
| 670 | US EPA OCSPP 850.2100: Avian oral toxicity test | Yes | N/A | test method | EPA | https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0154-0010 | Active Substance Part A (chemicals)8.1.1.1: Acute oral toxicity to birdsPPP Part A (chemicals)10.1.1.1: Acute oral toxicity to birds |
8.1.1.1: Acute oral toxicity to birds (283-A), 10.1.1.1: Acute oral toxicity to birds (284-A) | ||||||
| 671 | OECD Test Guideline 205: Avian Dietary Toxicity Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070004-en.pdf?expires=1673883648&id=id&accname=ocid194935&checksum=7400BA9F393BA9909D77ECB4E8C568F9 | Active Substance Part A (chemicals)8.1.1.2: Short-term dietary toxicity to birds |
8.1.1.2: Short-term dietary toxicity to birds (283-A) | ||||||
| 672 | US EPA OCSPP 850.2200: Avian dietary toxicity test | Yes | N/A | test method | EPA | https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0154-0011 | Active Substance Part A (chemicals)8.1.1.2: Short-term dietary toxicity to birds |
8.1.1.2: Short-term dietary toxicity to birds (283-A) | ||||||
| 673 | OECD Test Guideline 206: Avian Reproduction Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070028-en.pdf?expires=1673883771&id=id&accname=ocid194935&checksum=7BAC3288E5B80A78BB8CA0B8C3F092EC | Active Substance Part A (chemicals)8.1.1.3: Sub-chronic and reproductive toxicity to birds |
8.1.1.3: Sub-chronic and reproductive toxicity to birds (283-A) | ||||||
| 674 | US EPA OCSPP 850.2300: Avian Reproduction Test | Yes | N/A | test method | EPA | https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0154-0012 | Active Substance Part A (chemicals)8.1.1.3: Sub-chronic and reproductive toxicity to birds |
8.1.1.3: Sub-chronic and reproductive toxicity to birds (283-A) | ||||||
| 675 | OECD Test Guideline 248: Xenopus Eleutheroembryonic Thyroid Assay (XETA) | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/a13f80ee-en.pdf?expires=1673883949&id=id&accname=oid031827&checksum=6C46746E16552DE8D77B09B116012A1E | Active Substance Part A (chemicals)8.1.4: Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)PPP Part A (chemicals)10.1.3: Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) |
8.1.4: Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians) (283-A), 10.1.3: Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (284-A) | ||||||
| 676 | OECD Test Guideline 231: Amphibian Metamorphosis Assay | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264076242-en.pdf?expires=1673883970&id=id&accname=ocid194935&checksum=D1F96A2F2091BEB2CAB138872050AE97 | Active Substance Part A (chemicals)8.1.4: Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)PPP Part A (chemicals)10.1.3: Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) |
8.1.4: Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians) (283-A), 10.1.3: Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (284-A) | ||||||
| 677 | OECD Test Guideline 241: Larval Amphibian Growth and Development Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264242340-en.pdf?expires=1673883994&id=id&accname=oid031827&checksum=9ED1E20FE0AE545EDD868A480BEFD785 | Active Substance Part A (chemicals)8.1.4: Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)PPP Part A (chemicals)10.1.3: Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) |
8.1.4: Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians) (283-A), 10.1.3: Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (284-A) | ||||||
| 678 | OECD Test Guideline 203: Fish, Acute Toxicity Test | Yes | N/A | test method | OECD | https://read.oecd-ilibrary.org/environment/test-no-203-fish-acute-toxicity-test_9789264069961-en#page1 | Active Substance Part A (chemicals)8.2.1: Acute toxicity to fishActive Substance Part B (micro-organisms)8.2.1: Effects on fish |
8.2.1: Acute toxicity to fish (283-A), 8.2.1: Effects on fish (283-B) | Part B: For micro-organisms, 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 680 | US EPA protocol OCSPP 850.1500 Fish life cycle toxicity | Yes | N/A | test method | EPA | https://www.epa.gov/sites/default/files/2015-07/documents/850-1500.pdf | Active Substance Part A (chemicals)8.2.2.2: Fish full life cycle test |
8.2.2.2: Fish full life cycle test (283-A) | ||||||
| 681 | OECD Test Guideline 305: Bioaccumulation in Fish: Aqueous and Dietary Exposure | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264185296-en.pdf?expires=1673884791&id=id&accname=oid031827&checksum=8FE75F0F92CB39802E561BDFDCAC9DBC | Active Substance Part A (chemicals)8.2.2.3: Bioconcentration in fish |
8.2.2.3: Bioconcentration in fish (283-A) | ||||||
| 682 | OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264069947-en.pdf?expires=1673884879&id=id&accname=ocid194935&checksum=07A39F4B06F5AEAE74F0B6E78F1CAF0B | Active Substance Part A (chemicals)8.2.4.1: Acute toxicity to Daphnia magna |
8.2.4.1: Acute toxicity to Daphnia magna (283-A) | ||||||
| 683 | OECD Test Guideline 235: Chironomus sp., Acute Immobilisation Test | Yes | N/A | test method | OECD | https://read.oecd-ilibrary.org/environment/test-no-235-chironomus-sp-acute-immobilisation-test_9789264122383-en#page1 | Active Substance Part A (chemicals)8.2.4.2: Acute toxicity to an additional aquatic invertebrate species |
8.2.4.2: Acute toxicity to an additional aquatic invertebrate species (283-A) | Only one of the three species needs to be tested | |||||
| 684 | US EPA OCSPP 850.1035 Mysid Acute Toxicity Test | Yes | N/A | test method | EPA | https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0154-0038 | Active Substance Part A (chemicals)8.2.4.2: Acute toxicity to an additional aquatic invertebrate species |
8.2.4.2: Acute toxicity to an additional aquatic invertebrate species (283-A) | Only one of the three species needs to be tested | |||||
| 685 | US EPA 850.1025 (Oyster acute toxicity test) | Yes | N/A | test method | EPA | https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0154-0039 | Active Substance Part A (chemicals)8.2.4.2: Acute toxicity to an additional aquatic invertebrate species |
8.2.4.2: Acute toxicity to an additional aquatic invertebrate species (283-A) | Only one of the three species needs to be tested | |||||
| 686 | OECD Test Guideline 211: Daphnia magna Reproduction Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264304741-12-en.pdf?expires=1673884993&id=id&accname=oid031827&checksum=74D3B7FB040BA39353D501D0A69C8D7A | Active Substance Part A (chemicals)8.2.5.1: Reproductive and development toxicity to Daphnia magna |
8.2.5.1: Reproductive and development toxicity to Daphnia magna (283-A) | ||||||
| 687 | US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test | Yes | N/A | test method | EPA | https://www.regulations.gov/document/EPA-HQ-OPPT-2014-0766-0009 | Active Substance Part A (chemicals)8.2.5.2: Reproductive and development toxicity to an additional aquatic invertebrate species |
8.2.5.2: Reproductive and development toxicity to an additional aquatic invertebrate species (283-A) | Only one of the three species needs to be tested | |||||
| 688 | OECD Test Guideline 242: Potamopyrgus antipodarum Reproduction Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264311-en.pdf?expires=1673885065&id=id&accname=oid031827&checksum=948EDBDD690D1320DD42B86EA78D36F5 | Active Substance Part A (chemicals)8.2.5.2: Reproductive and development toxicity to an additional aquatic invertebrate species |
8.2.5.2: Reproductive and development toxicity to an additional aquatic invertebrate species (283-A) | Only one of the three species needs to be tested | |||||
| 689 | OECD Test Guideline 243: Lymnaea stagnalis Reproduction Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264335-en.pdf?expires=1673885088&id=id&accname=oid031827&checksum=994274E04D0FB1C781540EFEA7A517AB | Active Substance Part A (chemicals)8.2.5.2: Reproductive and development toxicity to an additional aquatic invertebrate species |
8.2.5.2: Reproductive and development toxicity to an additional aquatic invertebrate species (283-A) | Only one of the three species needs to be tested | |||||
| 690 | OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water | Yes | N/A | test method | OECD | https://read.oecd-ilibrary.org/environment/test-no-219-sediment-water-chironomid-toxicity-using-spiked-water_9789264070288-en#page1 | Active Substance Part A (chemicals)8.2.5.3: Development and emergence in Chironomus riparius |
8.2.5.3: Development and emergence in Chironomus riparius (283-A) | ||||||
| 691 | OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070264-en.pdf?expires=1673885980&id=id&accname=ocid194935&checksum=AE3E7EFF9D8D242116EEA8B0684D503E | Active Substance Part A (chemicals)8.2.5.4: Sediment dwelling organisms |
8.2.5.4: Sediment dwelling organisms (283-A) | ||||||
| 692 | OECD Test No. 233 (2010) Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264090910-en.pdf?expires=1673886004&id=id&accname=oid031827&checksum=32C21505BD4927E55EFEA221DC183E9D | Active Substance Part A (chemicals)8.2.5.4: Sediment dwelling organismsActive Substance Part B (micro-organisms)8.2.2: Effects on aquatic invertebrates |
8.2.5.4: Sediment dwelling organisms (283-A), 8.2.2: Effects on aquatic invertebrates (283-B) | Part B of Communication 283/2013 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 693 | OECD Test Guideline 225: Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264067356-en.pdf?expires=1673886032&id=id&accname=ocid194935&checksum=74150ECF5CD4F0DA0A8BE40B053A6BA1 | Active Substance Part A (chemicals)8.2.5.4: Sediment dwelling organisms |
8.2.5.4: Sediment dwelling organisms (283-A) | ||||||
| 695 | OECD Test No. 221 Lemna sp. Growth Inhibition Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264016194-en.pdf?expires=1673886077&id=id&accname=ocid194935&checksum=22FE7138996159A4022238CACCB39A94 | Active Substance Part A (chemicals)8.2.7: Effects on aquatic macrophytesActive Substance Part B (micro-organisms)8.2.4: Effects on aquatic macrophytes |
8.2.7: Effects on aquatic macrophytes (283-A), 8.2.4: Effects on aquatic macrophytes (283-B) | In Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 696 | ASTM E1913-04: Standard Guide for Conducting Static, Axenic, 14-Day Phytotoxicity Tests in Test Tubes with the Submersed Aquatic Macrophyte, Myriophyllum sibiricum Komarov | Yes | N/A | test method | https://www.astm.org/e1913-04.html | Active Substance Part A (chemicals)8.2.7: Effects on aquatic macrophytes |
8.2.7: Effects on aquatic macrophytes (283-A) | Test carried out until the date of publication of this Communication still valid, however new test shall be carried out in accordance with OECD 238 and 239 | ||||||
| 697 | 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. | Yes | N/A | test method | OECD | https://www.oecd.org/env/ehs/testing/OECD%20draft%20TG%20Myriophyllum%20water-sediment_July%202013.pdf | Active Substance Part A (chemicals)8.2.7: Effects on aquatic macrophytes |
8.2.7: Effects on aquatic macrophytes (283-A) | Test carried out until the date of publication of this Communication still valid, however new test shall be carried out in accordance with OECD 238 and 239 | |||||
| 700 | EPPO 170(4) Side-effects on honeybees | Yes | N/A | test method | EPPO | https://onlinelibrary.wiley.com/doi/10.1111/j.1365-2338.2010.02418.x | Active Substance Part A (chemicals)8.3.1.1.1: Acute oral toxicity8.3.1.1.2: Acute contact toxicity PPP Part A (chemicals)10.3.1.1.1: Acute oral toxicity10.3.1.1.2: Acute contact toxicity 10.3.1.5: Cage and tunnel tests |
8.3.1.1.1: Acute oral toxicity (283-A), 8.3.1.1.2: Acute contact toxicity (283-A), 10.3.1.1.1: Acute oral toxicity (284-A), 10.3.1.1.2: Acute contact toxicity (284-A), 10.3.1.5: Cage and tunnel tests (284-A) | ||||||
| 751 | CIPAC MT 41 Dilution stability of herbicide aqueous solutions | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/311-mt-41-dilution-stability-of-herbicide-aqueous-solutions?Itemid=210 | PPP Part A (chemicals)2.8.4: Degree of dissolution and dilution stabilityPPP Part B (micro-organisms)2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability |
2.8.4: Degree of dissolution and dilution stability (284-A), 2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-B) | ||||||
| 752 | CIPAC MT 179 Dissolution degree and solution stability | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/69-mt-179-1-degree-of-dissolution-and-solution-stability?Itemid=210 | PPP Part B (micro-organisms)2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability |
2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-B) | ||||||
| 753 | CIPAC Method MT 196: Solution Properties of Water Soluble Tablets | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/63-mt-196-solution-properties-of-water-soluble-tablets-st?Itemid=210 | PPP Part A (chemicals)2.8.4: Degree of dissolution and dilution stabilityPPP Part B (micro-organisms)2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability |
2.8.4: Degree of dissolution and dilution stability (284-A), 2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-B) | ||||||
| 754 | CIPAC Method MT 185: Wet sieve test | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/m-p/alphabetical-search | PPP Part A (chemicals)2.8.5.1: Particle size distributionPPP Part B (micro-organisms)2.7.4: Dry sieve test and wet sieve test2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) |
2.8.5.1: Particle size distribution (284-A), 2.7.4: Dry sieve test and wet sieve test (284-B), 2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) (284-B) | Applicable for water dispersible products | |||||
| 755 | CIPAC Method MT 187: Particle size analysis by laser diffraction | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/203-mt-187-particle-size-analysis-by-laser-diffraction?catid=2:uncategorised&Itemid=210 | PPP Part A (chemicals)2.8.5.1: Particle size distributionPPP Part B (micro-organisms)2.7.4: Dry sieve test and wet sieve test2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) |
2.8.5.1: Particle size distribution (284-A), 2.7.4: Dry sieve test and wet sieve test (284-B), 2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) (284-B) | Applicable for powders and granules | |||||
| 756 | CIPAC Method MT 170: Dry sieve analysis of water dispersible granules | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/98-mt-170-dry-sieve-analysis-of-water-dispersible-granules?Itemid=210 | PPP Part A (chemicals)2.8.5.1: Particle size distributionPPP Part B (micro-organisms)2.7.4: Dry sieve test and wet sieve test2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) |
2.8.5.1: Particle size distribution (284-A), 2.7.4: Dry sieve test and wet sieve test (284-B), 2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) (284-B) | Applicable for granules | |||||
| 757 | CIPAC Method MT 171: Dustiness of granular products | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/293-mt-171-dustiness-of-granulated-products?Itemid=210 | PPP Part A (chemicals)2.8.5.2: Dust contentPPP Part B (micro-organisms)2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)2.7.7: Flowability, pourability (rinsability) and dustability |
2.8.5.2: Dust content (284-A), 2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) (284-B), 2.7.7: Flowability, pourability (rinsability) and dustability (284-B) | ||||||
| 758 | CIPAC Method MT 178: Attrition resistance of granules | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/456-mt-178-attrition-resistance-of-granules?Itemid=210 | PPP Part A (chemicals)2.8.5.3: AttritionPPP Part B (micro-organisms)2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) |
2.8.5.3: Attrition (284-A), 2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) (284-B) | ||||||
| 759 | CIPAC Method MT 193: Attrition of tablets | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/65-mt-193-attrition-of-tablet?Itemid=210 | PPP Part A (chemicals)2.8.5.3: AttritionPPP Part B (micro-organisms)2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) |
2.8.5.3: Attrition (284-A), 2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) (284-B) | ||||||
| 760 | CIPAC Method MT 197: Disintegration of tablets | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/62-mt-197-disintegration-of-tablets?Itemid=210 | PPP Part A (chemicals)2.8.5.4: Hardness and integrityPPP Part B (micro-organisms)2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) |
2.8.5.4: Hardness and integrity (284-A), 2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) (284-B) | ||||||
| 763 | CIPAC Method MT 148: Pourability of suspension concentrates, | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/189-mt-148-1-pourability-of-suspension-concentrates?Itemid=210 | PPP Part A (chemicals)2.8.7: Flowability, pourability and dustabilityPPP Part B (micro-organisms)2.7.7: Flowability, pourability (rinsability) and dustability |
2.8.7: Flowability, pourability and dustability (284-A), 2.7.7: Flowability, pourability (rinsability) and dustability (284-B) | ||||||
| 764 | ASTM E1518 – 05: Standard Practice for Evaluation of Physical Compatibility of Pesticides in Aqueous Tank Mixtures by the Dynamic Shaker Method | Yes | N/A | test method | https://www.astm.org/e1518-05r19.html | PPP Part A (chemicals)2.9: Physical and chemical compatibility with other products including plant protection products with which its use is to be authorisedPPP Part B (micro-organisms)2.8: Physical and chemical compatibility with other plant protection products including plant protection products with which its use is to be authorised |
2.9: Physical and chemical compatibility with other products including plant protection products with which its use is to be authorised (284-A), 2.8: Physical and chemical compatibility with other plant protection products including plant protection products with which its use is to be authorised (284-B) | |||||||
| 765 | CIPAC MT 175: Seed treatment formulations, liquid, determination of seed-seed uniformity of distribution | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/326-mt-175-determination-of-seed-to-seed-uniformity-of-distribution-for-liquid-seed-treatment-formulations?catid=2:uncategorised&Itemid=210 | PPP Part A (chemicals)2.10: Adherence and distribution to seedsPPP Part B (micro-organisms)2.9: Adherence and distribution to seeds |
2.10: Adherence and distribution to seeds (284-A), 2.9: Adherence and distribution to seeds (284-B) | referred as CIPAC Method MT 175: Determination of seed-to-seed uniformity of distribution for liquid seed-treatment formulations in the Communication 284/2013 Part A | |||||
| 766 | CIPAC Method MT 194: Adhesion to Treated Seed | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/483-mt-194-adhesion-to-treated-seeds?Itemid=210 | PPP Part A (chemicals)2.10: Adherence and distribution to seedsPPP Part B (micro-organisms)2.9: Adherence and distribution to seeds |
2.10: Adherence and distribution to seeds (284-A), 2.9: Adherence and distribution to seeds (284-B) | ||||||
| 767 | 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. | Yes | N/A | test method | new author | https://www.abakusitsolutions.eu/ESTA/ESA_11.0387.1.pdf | PPP Part A (chemicals)2.10: Adherence and distribution to seedsPPP Part B (micro-organisms)2.9: Adherence and distribution to seeds |
2.10: Adherence and distribution to seeds (284-A), 2.9: Adherence and distribution to seeds (284-B) | ||||||
| 768 | Test methods reported in Annex I, Part II to Regulation (EC) No 1272/2008 | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32008R1272 | Active Substance Part A (chemicals)2.14: Other studiesPPP Part A (chemicals)2.11: Other studies |
2.14: Other studies (283-A), 2.11: Other studies (284-A) | ||||||
| 769 | CIPAC Method MT 176 Dissolution rate of water soluble bags | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/299-mt-176-dissolution-rate-of-water-soluble-bags?Itemid=210 | PPP Part A (chemicals)2.11: Other studies |
2.11: Other studies (284-A) | ||||||
| 770 | CIPAC Method MT 23 Miscibility with hydrocarbon oil | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/210-mt-23-miscibility-with-hydrocarbon-oil?Itemid=210 | PPP Part A (chemicals)2.11: Other studies |
2.11: Other studies (284-A) | ||||||
| 771 | EPPO Standard PP1/239: Dose expression of plant protection products | Yes | Yes | guidance document,
test method |
EPPO | https://pp1.eppo.int/standards/PP1-239-3 | PPP Part A (chemicals)3: Data on applicationPPP Part B (micro-organisms)3.4: Application rate |
3: Data on application (284-A), 3.4: Application rate (284-B) | ||||||
| 772 | EPPO Standard PP1/240: Harmonized basic information for databases on plant protection products | Yes | N/A | test method | EPPO | https://pp1.eppo.int/standards/PP1-240-1 | PPP Part A (chemicals)3: Data on application |
3: Data on application (284-A) | ||||||
| 773 | EPPO Standard PP1/248: Harmonized system for classification and coding of the uses of plant protection products | Yes | Yes | guidance document,
test method |
EPPO | https://pp1.eppo.int/standards/PP1-248-3 | Active Substance Part B (micro-organisms)3.1: Function and target organism3.3: Crops or products protected or treated PPP Part A (chemicals)3: Data on applicationPPP Part B (micro-organisms)3.3: Function, target organisms and plants or plants products to be protected and possible risk mitigation measures |
3.1: Function and target organism (283-B), 3.3: Crops or products protected or treated (283-B), 3: Data on application (284-A), 3.3: Function, target organisms and plants or plants products to be protected and possible risk mitigation measures (284-B) | Please consider only those uses which are deemed relevant under the scope of Reg (EC) No 1107/2009, and not those in EPPO PP 1/248 which refer to biostimulant claims as defined both under the scope of Reg (EU) No 2019/1009 and under the technical specifications CEN/TS 17724, CEN/TS 17700-1, CEN/TS 17700-2, CEN/TS 17700-3, CEN/TS 17700-4, CEN/TS 17700-5, even if these biostimulants are identified as plant growth regulators in EPPO PP1/248. | referred as guidance document and test method in the Communication 284/2013-Part A and as guidance document in the Communication 283/2013-Part B | ||||
| 774 | EPPO Standard PP1/291: Evaluation of the influence of tank mix adjuvants on the efficacy of plant protection products | Yes | N/A | test method | EPPO | https://pp1.eppo.int/standards/PP1-291-1 | PPP Part A (chemicals)3: Data on application |
3: Data on application (284-A) | ||||||
| 775 | EPPO Standard PP1/306: General principles for the development of co-formulated mixtures of plant protection products | Yes | N/A | test method | EPPO | https://pp1.eppo.int/standards/PP1-306-1 | PPP Part A (chemicals)3: Data on application |
3: Data on application (284-A) | ||||||
| 779 | ISTA Methods | Yes | N/A | test method | https://ista.org/docs/ISTA_2017_Guidelines.pdf | PPP Part A (chemicals)6.4.5: Impact on treated plants or plant products to be used for propagation |
6.4.5: Impact on treated plants or plant products to be used for propagation (284-A) | For seeds harvested from treated plants | ||||||
| 780 | OECD Test Guideline 428: Skin absorption: in vitro method | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264071087-en.pdf?expires=1674145266&id=id&accname=ocid194935&checksum=5900E884914C3E8432AEB5714473C9CC | PPP Part A (chemicals)7.3: Dermal absorptionPPP Part B (micro-organisms)7.5: Data on exposure |
7.3: Dermal absorption (284-A), 7.5: Data on exposure (284-B) | ||||||
| 781 | OECD Test Guideline 427: Skin absorption: in vivo method | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264071063-en.pdf?expires=1674145287&id=id&accname=ocid194935&checksum=93FF9B7A7CF0114EAB53D91D9822C0D8 | PPP Part A (chemicals)7.3: Dermal absorptionPPP Part B (micro-organisms)7.5: Data on exposure |
7.3: Dermal absorption (284-A), 7.5: Data on exposure (284-B) | ||||||
| 782 | OECD Guidance Document on the Honey Bee (Apis mellifera L.) Brood test Under Semi-field Conditions. Series on Testing and Assessment, No. 75 | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264085510-en.pdf?expires=1674145365&id=id&accname=oid031827&checksum=C73858681174432AD072AE6E973C77C8 | Active Substance Part B (micro-organisms)8.3: Effects on bees |
8.3: Effects on bees (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 784 | 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) | Yes | N/A | test method | https://link.springer.com/article/10.1007/s10526-009-9260-7 | PPP Part A (chemicals)10.3.2.2: Extended laboratory testing, aged residue studies with non-target arthropods |
10.3.2.2: Extended laboratory testing, aged residue studies with non-target arthropods (284-A) | |||||||
| 785 | US EPA Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals and Supporting Retrospective Analysis (2020) ID: EPA 705-G-2020-3722 | No | N/A | supporting document | EPA | https://www.epa.gov/sites/default/files/2021-01/documents/guidance-for-waiving-acute-dermal-toxicity.pdf | ||||||||
| 787 | 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) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2016-10/pesticides_aas_guidance_baculovirus.pdf | Active Substance Part B (micro-organisms)0: General Guidance |
0: General Guidance (283-B) | ||||||
| 788 | EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6506 | Active Substance Part B (micro-organisms)0: General Guidance2.7: Genetic stability and factors affecting it 2.8: Information on metabolites of concern |
0: General Guidance (283-B), 2.7: Genetic stability and factors affecting it (283-B), 2.8: Information on metabolites of concern (283-B) | ||||||
| 789 | OECD Guidance Document for the Regulatory Framework for the Microorganism Group: Bacteriophages Series on Pesticides No. 108 | Yes | Yes | guidance document | OECD | https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/CBC/MONO(2022)40&docLanguage=en | Active Substance Part B (micro-organisms)0: General Guidance |
0: General Guidance (283-B) | ||||||
| 790 | OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 | Yes | Yes | guidance document | OECD | https://www.oecd-ilibrary.org/docserver/9789264221642-en.pdf?expires=1674481457&id=id&accname=guest&checksum=A1300366D50234660C459D1480A5B8BC | Active Substance Part B (micro-organisms)1.4.2.2: Identity and content of relevant contaminating micro-organisms4.1: Methods for the analysis of the MPCA as manufactured PPP Part B (micro-organisms)1.4: Detailed quantitative and qualitative information on the composition of the preparation2.6: Storage stability and shelf life 5.1: Methods for the analysis of the preparation |
1.4.2.2: Identity and content of relevant contaminating micro-organisms (283-B), 4.1: Methods for the analysis of the MPCA as manufactured (283-B), 1.4: Detailed quantitative and qualitative information on the composition of the preparation (284-B), 2.6: Storage stability and shelf life (284-B), 5.1: Methods for the analysis of the preparation (284-B) | ||||||
| 791 | US EPA OPPTS 885.3400 hypersensitivity Incidents | Yes | N/A | test method | EPA | https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0159-0023 | Active Substance Part B (micro-organisms)5.1.3: Information on sensitisation and allergenicity |
5.1.3: Information on sensitisation and allergenicity (283-B) | ||||||
| 792 | US EPA OPPTS 885.3050 Acute Oral Toxicity/ Pathogenicity | Yes | N/A | test method | EPA | https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0159-0019 | Active Substance Part B (micro-organisms)5.3.1.1: Oral infectivity and pathogenicity |
5.3.1.1: Oral infectivity and pathogenicity (283-B) | ||||||
| 793 | US EPA OPPTS 885.3150 Acute pulmonary toxicity/ pathogenicity | Yes | N/A | test method | EPA | https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0159-0021 | Active Substance Part B (micro-organisms)5.3.1.2: Intratracheal/ intranasal infectivity and pathogenicity |
5.3.1.2: Intratracheal/ intranasal infectivity and pathogenicity (283-B) | ||||||
| 794 | US EPA OPPTS 885.3200 Microbial pesticide test methods. Acute injection toxicity/pathogenicity | Yes | N/A | test method | EPA | https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0159-0022 | Active Substance Part B (micro-organisms)5.3.1.3: Intravenous, intraperitoneal or subcutaneous single exposure |
5.3.1.3: Intravenous, intraperitoneal or subcutaneous single exposure (283-B) | ||||||
| 795 | US EPA OPPTS 885.3500 Cell culture | Yes | N/A | test method | EPA | https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0159-0024 | Active Substance Part B (micro-organisms)5.3.2: Cell culture study |
5.3.2: Cell culture study (283-B) | ||||||
| 796 | US EPA OPPTS 885.3600 Subchronic Toxicity/Pathogenicity | Yes | N/A | test method | EPA | https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0159-0026 | Active Substance Part B (micro-organisms)5.4: Specific infectivity and pathogenicity studies on the micro-organism |
5.4: Specific infectivity and pathogenicity studies on the micro-organism (283-B) | ||||||
| 797 | US EPA OPPTS 885.3650 Reproductive/fertility effects | Yes | N/A | test method | EPA | https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0159-0027 | Active Substance Part B (micro-organisms)5.4: Specific infectivity and pathogenicity studies on the micro-organism |
5.4: Specific infectivity and pathogenicity studies on the micro-organism (283-B) | ||||||
| 799 | 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) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2014.3615 | https://food.ec.europa.eu/document/download/8b3db10c-005d-4e1e-b2f7-1d426aa23c93_en?filename=pesticides_ppp_app-proc_guide_fate_efsa_protected-crops.pdf | Active Substance Part B (micro-organisms)7.1.1: Predicted environmental density of the micro-organism |
7.1.1: Predicted environmental density of the micro-organism (283-B) | |||||
| 800 | EU Guidance document on the approval and low-risk criteria linked to “antimicrobial resistance" applicable to microorganisms used for plant protection in accordance with Regulation (EC) No 1107/2009 (SANTE/2020/12260) | Yes | Yes | guidance document | SANTE | https://food.ec.europa.eu/system/files/2020-11/pesticides_ppp_app-proc_guide_180652_microorganism-amr_202011.pdf | Active Substance Part B (micro-organisms)2.9: Presence of transferable antimicrobial resistance genes |
2.9: Presence of transferable antimicrobial resistance genes (283-B) | ||||||
| 801 | 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. | Yes | No | https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_fate_wd-env-sft-eval-mbca.pdf https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0159-0028 https://publications.gc.ca/site/eng/9.827958/publication.html | Active Substance Part B (micro-organisms)8: Ecotoxicological studies |
8: Ecotoxicological studies (283-B) | ||||||||
| 802 | US EPA OCSPP 885.4240 Freshwater invertebrate Tier I | Yes | N/A | test method | EPA | https://nepis.epa.gov/Exe/ZyNET.exe/P100I7A1.txt?ZyActionD=ZyDocument&Client=EPA&Index=1995%20Thru%201999&Docs=&Query=&Time=&EndTime=&SearchMethod=1&TocRestrict=n&Toc=&TocEntry=&QField=&QFieldYear=&QFieldMonth=&QFieldDay=&UseQField=&IntQFieldOp=0&ExtQFieldOp=0&XmlQuery=&File=D%3A%5CZYFILES%5CINDEX%20DATA%5C95THRU99%5CTXT%5C00000034%5CP100I7A1.txt&User=ANONYMOUS&Password=anonymous&SortMethod=h%7C-&MaximumDocuments=1&FuzzyDegree=0&ImageQuality=r75g8/r75g8/x150y150g16/i425&Display=hpfr&DefSeekPage=x&SearchBack=ZyActionL&Back=ZyActionS&BackDesc=Results%20page&MaximumPages=1&ZyEntry=3 | Active Substance Part B (micro-organisms)8.2.2: Effects on aquatic invertebrates |
8.2.2: Effects on aquatic invertebrates (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 805 | Test O.3: Gravimetric test for oxidising solids, Part III of UN RTDG Manual of Tests and Criteria | Yes | N/A | test method | UN RTDG | https://unece.org/sites/default/files/2023-11/ST_SG_AC.10_11_Rev.8e_WEB.pdf | Active Substance Part A (chemicals)2.13: Oxidising propertiesPPP Part A (chemicals)2.2: Explosive and oxidising properties |
2.13: Oxidising properties (283-A), 2.2: Explosive and oxidising properties (284-A) | ||||||
| 701 | OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test | Yes | N/A | test method | OECD | https://read.oecd-ilibrary.org/environment/test-no-213-honeybees-acute-oral-toxicity-test_9789264070165-en#page1 | Active Substance Part A (chemicals)8.3.1.1.1: Acute oral toxicityActive Substance Part B (micro-organisms)8.3: Effects on beesPPP Part A (chemicals)10.3.1.1.1: Acute oral toxicity |
8.3.1.1.1: Acute oral toxicity (283-A), 8.3: Effects on bees (283-B), 10.3.1.1.1: Acute oral toxicity (284-A) | In Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 703 | OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070189-en.pdf?expires=1673952282&id=id&accname=oid031827&checksum=F785B4EEDCDDF4E08CF4473F5ACF6382 | Active Substance Part A (chemicals)8.3.1.1.2: Acute contact toxicityActive Substance Part B (micro-organisms)8.3: Effects on beesPPP Part A (chemicals)10.3.1.1.2: Acute contact toxicity |
8.3.1.1.2: Acute contact toxicity (283-A), 8.3: Effects on bees (283-B), 10.3.1.1.2: Acute contact toxicity (284-A) | In Part B of the Communication 283/2013: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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 704 | OECD Test Guideline 246: Bumblebee, Acute Contact Toxicity Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264284104-en.pdf?expires=1673952368&id=id&accname=oid031827&checksum=BBFD08C35D48D81F17228DB11E354DE9 | Active Substance Part A (chemicals)8.3.1.1.2: Acute contact toxicityPPP Part A (chemicals)10.3.1.1.2: Acute contact toxicity |
8.3.1.1.2: Acute contact toxicity (283-A), 10.3.1.1.2: Acute contact toxicity (284-A) | ||||||
| 705 | OECD Test Guideline 245 Honey Bee (Apis mellifera l.), Chronic Oral Toxicity Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264284081-en.pdf?expires=1673952317&id=id&accname=oid031827&checksum=D7ED2313A12F8422C799F7C80EAC83B4 | Active Substance Part A (chemicals)8.3.1.2: Chronic toxicity to beesActive Substance Part B (micro-organisms)8.3: Effects on beesPPP Part A (chemicals)10.3.1.2: Chronic toxicity to bees |
8.3.1.2: Chronic toxicity to bees (283-A), 8.3: Effects on bees (283-B), 10.3.1.2: Chronic toxicity to bees (284-A) | In Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 706 | 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 | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264085510-en.pdf?expires=1673952414&id=id&accname=oid031827&checksum=47CB7A4224F8B19A00158A461B354706 | Active Substance Part A (chemicals)8.3.1.3: Effects on honeybee development and other honeybee life stagesPPP Part A (chemicals)10.3.1.3: Effects on honey bee development and other honey bee life stages10.3.1.5: Cage and tunnel tests 10.6.3: Extended laboratory studies on non-target plants |
8.3.1.3: Effects on honeybee development and other honeybee life stages (283-A), 10.3.1.3: Effects on honey bee development and other honey bee life stages (284-A), 10.3.1.5: Cage and tunnel tests (284-A), 10.6.3: Extended laboratory studies on non-target plants (284-A) | ||||||
| 708 | OECD Test Guideline No. 237 - Honey Bee (Apis mellifera) Larval Toxicity Test, Single Exposure | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264203723-en.pdf?expires=1673952504&id=id&accname=oid031827&checksum=FDC3B3DDC74F1941EE49F71B3556FFB0 | Active Substance Part A (chemicals)8.3.1.3: Effects on honeybee development and other honeybee life stagesPPP Part A (chemicals)10.3.1.3: Effects on honey bee development and other honey bee life stages |
8.3.1.3: Effects on honeybee development and other honeybee life stages (283-A), 10.3.1.3: Effects on honey bee development and other honey bee life stages (284-A) | ||||||
| 709 | 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. | Yes | N/A | test method | EPPO | https://onlinelibrary.wiley.com/doi/10.1111/j.1365-2338.1992.tb00546.x | Active Substance Part A (chemicals)8.3.1.3: Effects on honeybee development and other honeybee life stagesPPP Part A (chemicals)10.3.1.3: Effects on honey bee development and other honey bee life stages10.3.1.6: Field tests with honeybees |
8.3.1.3: Effects on honeybee development and other honeybee life stages (283-A), 10.3.1.3: Effects on honey bee development and other honey bee life stages (284-A), 10.3.1.6: Field tests with honeybees (284-A) | ||||||
| 710 | 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. | Yes | N/A | test method | OECD | https://one.oecd.org/document/ENV/CBC/MONO(2021)7/en/pdf | Active Substance Part A (chemicals)8.3.1.4: Sub-lethal effectsPPP Part A (chemicals)10.3.1.4: Sub-lethal effects |
8.3.1.4: Sub-lethal effects (283-A), 10.3.1.4: Sub-lethal effects (284-A) | ||||||
| 711 | 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) | Yes | N/A | test method | EPPO | https://www.researchgate.net/profile/Elisa-Vinuela/publication/286239858_Laboratory_method_to_test_effects_of_plant_protection_products_on_larvae_of_Chrysoperla_carnea_Neuroptera_Chrysopidae/links/5f7c2b5d92851c14bcb16eb8/Laboratory-method-to-test-effects-of-plant-protection-products-on-larvae-of-Chrysoperla-carnea-Neuroptera-Chrysopidae.pdf | PPP Part A (chemicals)10.3.2.1: Standard laboratory testing for non-target arthropods10.3.2.2: Extended laboratory testing, aged residue studies with non-target arthropods 10.3.2.3: Semi-field studies with non-target arthropods 10.3.2.4: Field studies with non-target arthropods |
10.3.2.1: Standard laboratory testing for non-target arthropods (284-A), 10.3.2.2: Extended laboratory testing, aged residue studies with non-target arthropods (284-A), 10.3.2.3: Semi-field studies with non-target arthropods (284-A), 10.3.2.4: Field studies with non-target arthropods (284-A) | ||||||
| 712 | OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264496-en.pdf?expires=1673953315&id=id&accname=oid031827&checksum=F97C5A36A58FF3D47213920B346D557E | Active Substance Part A (chemicals)8.4.1: Earthworm — sub-lethal effectsActive Substance Part B (micro-organisms)8.5: Effects on non-target meso- and macro-organisms in soilPPP Part A (chemicals)10.4.1.1: Earthworms — sub-lethal effects |
8.4.1: Earthworm — sub-lethal effects (283-A), 8.5: Effects on non-target meso- and macro-organisms in soil (283-B), 10.4.1.1: Earthworms — sub-lethal effects (284-A) | In Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 714 | ISO 23611-1:2018: Soil quality - Sampling of soil invertebrates - Part 1: Hand-sorting and extraction of earthworms | Yes | N/A | test method | https://www.iso.org/standard/70449.html | Active Substance Part A (chemicals)8.4.1: Earthworm — sub-lethal effects |
8.4.1: Earthworm — sub-lethal effects (283-A) | |||||||
| 715 | ISO 23611-2:2006 Soil Quality - Sampling of soil invertebrates - Part 2: Sampling and extraction of micro-arthropods (Collembola and Acarina) | Yes | N/A | test method | https://www.iso.org/standard/37027.html | Active Substance Part A (chemicals)8.4.2: Effects on non-target soil meso- and macrofauna (other than earthworms)PPP Part A (chemicals)10.4.2: Effects on non-target soil meso- and macrofauna (other than earthworms) |
8.4.2: Effects on non-target soil meso- and macrofauna (other than earthworms) (283-A), 10.4.2: Effects on non-target soil meso- and macrofauna (other than earthworms) (284-A) | |||||||
| 717 | OECD Test No. 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264557-en.pdf?expires=1673954815&id=id&accname=oid031827&checksum=4A3A5A60743AED752E3B5B69ACD1CBBC | Active Substance Part A (chemicals)8.4.2.1: Species level testingActive Substance Part B (micro-organisms)8.5: Effects on non-target meso- and macro-organisms in soilPPP Part A (chemicals)10.4.2.1: Species level testing |
8.4.2.1: Species level testing (283-A), 8.5: Effects on non-target meso- and macro-organisms in soil (283-B), 10.4.2.1: Species level testing (284-A) | In Part B of the Communication 283/2013: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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 718 | OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070226-en.pdf?expires=1673954865&id=id&accname=ocid194935&checksum=AF982AF23BBC1E85B64105056A53ED09 | Active Substance Part A (chemicals)8.5: Effects on soil nitrogen transformationPPP Part A (chemicals)10.5: Effects on soil nitrogen transformation |
8.5: Effects on soil nitrogen transformation (283-A), 10.5: Effects on soil nitrogen transformation (284-A) | ||||||
| 721 | OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070080-en.pdf?expires=1673955009&id=id&accname=oid031827&checksum=BA6EA440CC389C9D78ABF264AB4AFA54 | Active Substance Part A (chemicals)8.8: Effects on biological methods for sewage treatment |
8.8: Effects on biological methods for sewage treatment (283-A) | ||||||
| 722 |
Guidance documents reported in Section 6 of Annex I to Commission Communication C(2023) 6245
|
Yes | Yes | guidance document,
test method |
PPP Part A (chemicals)8: Residues in or on treated products, food and feed |
8: Residues in or on treated products, food and feed (284-A) | for the test method: According to Section 8 of Part A of the Annex to Commission Regulation (EU) No 284/2013, data and information on residues in or on treated products, food and feed in accordance with Section 6 of Part A of the Annex to Regulation (EU) No 283/2013 must be submitted, unless the applicant shows that the data and information already submitted for the active substance can be applied. | |||||||
| 723 |
Guidance documents reported in Section 7.1.2 and 7.1.3.1 of Annex I to Commission Communication C(2023) 6245
|
Yes | Yes | guidance document | PPP Part A (chemicals)9.1.2.1: Laboratory studies |
9.1.2.1: Laboratory studies (284-A) | According to Section 9.1.2.1. of Part A of the Annex to Commission Regulation (EU) No 284/2013, the same provisions as provided under points 7.1.2 and 7.1.3.1. of Part A of the Annex to Regulation (EU) No 283/2013 apply. | |||||||
| 724 |
Guidance documents reported in point 8.2. of Annex I to Commission Communication C(2023) 6245
|
Yes | Yes | guidance document | PPP Part A (chemicals)10.2.1: Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes |
10.2.1: Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes (284-A) | According to Section 10.2.1. of Part A of the Annex to Commission Regulation (EU) No 284/2013, tests must be carried out on one species from each of the three/four groups of aquatic organisms, that is to say fish, aquatic invertebrates, algae and, where relevant, macrophytes as referred to in point 8.2 of Part A of the Annex to Regulation (EU) No 283/2013, if the plant protection product itself may contaminate water. | |||||||
| 727 | Method A.14 Explosive properties (Annex of Regulation (EC) No 440/2008). | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.11: Explosive propertiesPPP Part A (chemicals)2.2: Explosive and oxidising properties |
2.11: Explosive properties (283-A), 2.2: Explosive and oxidising properties (284-A) | ||||||
| 728 | Method A.17 Oxidising properties (solids) (Annex of Regulation (EC) No 440/2008) | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.13: Oxidising propertiesPPP Part A (chemicals)2.2: Explosive and oxidising properties |
2.13: Oxidising properties (283-A), 2.2: Explosive and oxidising properties (284-A) | For solid preparations | |||||
| 729 | Method A.21 Oxidising properties (liquids) (Annex of Regulation (EC) No 440/2008) | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.13: Oxidising propertiesPPP Part A (chemicals)2.2: Explosive and oxidising properties |
2.13: Oxidising properties (283-A), 2.2: Explosive and oxidising properties (284-A) | ||||||
| 730 | Method A.10 Flammability (Annex of Regulation (EC) No. 440/2008) for solids (solids) | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.9: Flammability and self-heatingPPP Part A (chemicals)2.3: Flammability and self-heating |
2.9: Flammability and self-heating (283-A), 2.3: Flammability and self-heating (284-A) | ||||||
| 731 | Method A.11 Flammability (Annex of Regulation (EC) No. 440/2008) for gaseous materials | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.9: Flammability and self-heatingPPP Part A (chemicals)2.3: Flammability and self-heating |
2.9: Flammability and self-heating (283-A), 2.3: Flammability and self-heating (284-A) | ||||||
| 732 | Method A.12 (Annex of Regulation (EC) No. 440/2008) for contact with water | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.9: Flammability and self-heatingPPP Part A (chemicals)2.3: Flammability and self-heating |
2.9: Flammability and self-heating (283-A), 2.3: Flammability and self-heating (284-A) | ||||||
| 733 | 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 | Yes | N/A | test method | UN RTDG | https://unece.org/sites/default/files/2023-11/ST_SG_AC.10_11_Rev.8e_WEB.pdf | Active Substance Part A (chemicals)2.9: Flammability and self-heating |
2.9: Flammability and self-heating (283-A) | ||||||
| 734 | CIPAC Method MT 75: Determination of pH values | Yes | N/A | test method | OECD | https://www.oecd.org/chemicalsafety/testing/49070189.pdf | PPP Part A (chemicals)2.4: Acidity/alkalinity and pH value |
2.4: Acidity/alkalinity and pH value (284-A) | ||||||
| 735 | CIPAC Method MT 31: free acidity or alkalinity | Yes | N/A | test method | OECD | https://www.cipac.org/index.php/component/content/article/271-mt-31-free-acidity-or-alkalinity?catid=2:uncategorised&Itemid=210 | PPP Part A (chemicals)2.4: Acidity/alkalinity and pH value |
2.4: Acidity/alkalinity and pH value (284-A) | ||||||
| 736 | CIPAC Method MT 191: Acidity or alkalinity of formulations | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/482-mt-191-acidity-or-alkalinity-of-formulations?Itemid=210 | PPP Part A (chemicals)2.4: Acidity/alkalinity and pH value |
2.4: Acidity/alkalinity and pH value (284-A) | ||||||
| 737 | OECD Test Guideline 122 - Determination of pH, Acidity and Alkalinity | Yes | N/A | test method | OECD | https://read.oecd-ilibrary.org/environment/test-no-122-determination-of-ph-acidity-and-alkalinity_9789264203686-en#page1 | PPP Part A (chemicals)2.4: Acidity/alkalinity and pH value |
2.4: Acidity/alkalinity and pH value (284-A) | ||||||
| 738 | OECD Test Guideline 114 - Viscosity of Liquids | Yes | N/A | test method | OECD | https://one.oecd.org/document/env/jm/mono(2010)6/en/pdf | PPP Part A (chemicals)2.5: Viscosity and surface tension |
2.5: Viscosity and surface tension (284-A) | Applicable for newtonian or non-newtonian liquids | |||||
| 739 | CIPAC method MT 192: Viscosity of liquids by rotational viscosimetry | Yes | N/A | test method | CIPAC | https://www.cipac.org/images/pdf/CE_MT%20192_final.pdf#:~:text=%2AMT%20192%20VISCOSITY%20OF%20LIQUIDS%20BY%20ROTATIONAL%20VISCOMETRY,liquids%20is%20best%20carried%20out%20by%20rotational%20viscosimeters. | PPP Part A (chemicals)2.5: Viscosity and surface tension |
2.5: Viscosity and surface tension (284-A) | Applicable for newtonian or non-newtonian liquids | |||||
| 740 | Method A.3 Relative density (Annex of Regulation (EC) No 440/2008). | Yes | N/A | test method | https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32008R0440 | PPP Part A (chemicals)2.6: Relative density and bulk density |
2.6: Relative density and bulk density (284-A) | |||||||
| 741 | OECD Test Guideline 109 - Density of Liquids and Solids | Yes | N/A | test method | OECD | https://read.oecd-ilibrary.org/environment/test-no-109-density-of-liquids-and-solids_9789264123298-en#page1 | PPP Part A (chemicals)2.6: Relative density and bulk density |
2.6: Relative density and bulk density (284-A) | ||||||
| 742 | CIPAC Method MT 186: Bulk density | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php?option=com_content&view=article&id=432:metsulfuron-methyl&catid=432&Itemid=881 | PPP Part A (chemicals)2.6: Relative density and bulk density |
2.6: Relative density and bulk density (284-A) | ||||||
| 743 | CIPAC Method MT 46: Accelerated storage procedure | Yes | N/A | test method | CIPAC | https://cipac.org/index.php/a2/2-uncategorised/37-mt-46-4-accelerated-storage-procedure | PPP Part A (chemicals)2.7: Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection productPPP Part B (micro-organisms)2.6.2: Effects of temperature and packaging |
2.7: Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection product (284-A), 2.6.2: Effects of temperature and packaging (284-B) | ||||||
| 744 | CIPAC MT 39 Stability of liquid formulations at 0˚C | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/335-mt-39-stability-of-liquid-formulations-at-0-c?Itemid=210 | PPP Part A (chemicals)2.7: Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection productPPP Part B (micro-organisms)2.6.2: Effects of temperature and packaging |
2.7: Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection product (284-A), 2.6.2: Effects of temperature and packaging (284-B) | referred as CIPAC Method MT 39: Low temperature stability of liquid formulations in the Communication 284/2013- Part A | |||||
| 745 | CIPAC Method MT 53: Wettability | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/103-mt-53-wettability?Itemid=210 | PPP Part A (chemicals)2.8.1: WettabilityPPP Part B (micro-organisms)2.7.1: Wettability |
2.8.1: Wettability (284-A), 2.7.1: Wettability (284-B) | ||||||
| 746 | CIPAC Method MT 47 Persistent foaming | Yes | N/A | test method | CIPAC | https://drugdevelopment.labcorp.com/catalog/persistent-foaming-for-physicochemical-properties-testing.html#:~:text=The%20persistent%20foaming%20test%20(CIPAC,use%2C%20putting%20operators%20at%20risk. | PPP Part A (chemicals)2.8.2: Persistent foamingPPP Part B (micro-organisms)2.7.2: Persistent foaming |
2.8.2: Persistent foaming (284-A), 2.7.2: Persistent foaming (284-B) | ||||||
| 747 | CIPAC Method MT 184: Suspensibility of formulations forming suspensions on dilution with water | Yes | N/A | test method | CIPAC | https://cipac.org/index.php/a1/2-uncategorised/34-mt-184-1-suspensibility-of-formulations-forming-suspensions-on-dilution-with-water | PPP Part A (chemicals)2.8.3: Suspensibility, spontaneity of dispersion and dispersion stabilityPPP Part B (micro-organisms)2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability |
2.8.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-A), 2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-B) | ||||||
| 748 | CIPAC Method MT 160: Spontaneity of dispersion of suspension concentrates | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/150-mt-160-spontaneity-of-dispersion-of-suspension-concentrates?Itemid=210 | PPP Part A (chemicals)2.8.3: Suspensibility, spontaneity of dispersion and dispersion stabilityPPP Part B (micro-organisms)2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability |
2.8.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-A), 2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-B) | ||||||
| 749 | CIPAC Method MT 174: Dispersibility of water dispersible granules | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/149-mt-174-dispersibility-of-water-dispersible-granules?Itemid=210 | PPP Part A (chemicals)2.8.3: Suspensibility, spontaneity of dispersion and dispersion stabilityPPP Part B (micro-organisms)2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability |
2.8.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-A), 2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-B) | ||||||
| 750 | CIPAC Method MT 180: Dispersion stability of suspo-emulsion | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/2-uncategorised/68-mt-180-dispersion-stability-of-suspo-emulsions?Itemid=210 | PPP Part A (chemicals)2.8.3: Suspensibility, spontaneity of dispersion and dispersion stabilityPPP Part B (micro-organisms)2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability |
2.8.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-A), 2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability (284-B) | ||||||
| 628 | OECD Test Guideline 475: Mammalian Bone Marrow Chromosome Aberration Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264786-en.pdf?expires=1673878908&id=id&accname=oid031827&checksum=6C15A2AFE8D2C655B06901CB583E10C3 | Active Substance Part A (chemicals)5.4.2: In vivo studies in somatic cells |
5.4.2: In vivo studies in somatic cells (283-A) | The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested | |||||
| 629 | OECD Test Guideline 486: Unscheduled DNA synthesis (UDS) - Test with mammalian liver cells in vivo | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264071520-en.pdf?expires=1673878928&id=id&accname=ocid194935&checksum=ACFAF8B89CF66572E5DBF25482C6671C | Active Substance Part A (chemicals)5.4.2: In vivo studies in somatic cells |
5.4.2: In vivo studies in somatic cells (283-A) | The results of a UDS test may be considered as adequate to assess genotoxic potential only in cases of positive results Existing tests are acceptable, but no new test carried out according to this guideline is recommended - EFSA Opinion of the Scientific Committee (2017) | |||||
| 630 | OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264203907-en.pdf?expires=1673879380&id=id&accname=guest&checksum=3B6CC3ADDD5AF2C0A3C5C9A88AAC92F1 | Active Substance Part A (chemicals)5.4.2: In vivo studies in somatic cells5.4.3: In vivo studies in germ cells |
5.4.2: In vivo studies in somatic cells (283-A), 5.4.3: In vivo studies in germ cells (283-A) | The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested | |||||
| 631 | OECD test guideline 489: In Vivo Mammalian Alkaline Comet Assay | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264885-en.pdf?expires=1673879401&id=id&accname=oid031827&checksum=261DF53936EEE5D2C21DEB552A8FA206 | Active Substance Part A (chemicals)5.4.2: In vivo studies in somatic cells |
5.4.2: In vivo studies in somatic cells (283-A) | The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested | |||||
| 632 | OECD Test Guideline 483: Mammalian Spermatogonial Chromosome Aberration Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264847-en.pdf?expires=1673879437&id=id&accname=oid031827&checksum=9BBD6C42C65181617B397A250D83B186 | Active Substance Part A (chemicals)5.4.3: In vivo studies in germ cells |
5.4.3: In vivo studies in germ cells (283-A) | The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested | |||||
| 633 | OECD Test Guideline 478: Rodent Dominant Lethal Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264823-en.pdf?expires=1673879533&id=id&accname=oid031827&checksum=A3828C77AD1F758308D0A9CF093B10A3 | Active Substance Part A (chemicals)5.4.3: In vivo studies in germ cells |
5.4.3: In vivo studies in germ cells (283-A) | The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested | |||||
| 634 | OECD Test Guideline 453: Combined Chronic Toxicity/Carcinogenicity Studies | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-453-combined-chronic-toxicity-carcinogenicity-studies_9789264071223-en | Active Substance Part A (chemicals)5.5: Long-term toxicity and carcinogenicity |
5.5: Long-term toxicity and carcinogenicity (283-A) | ||||||
| 635 | OECD Test Guideline 451: Carcinogenicity Studies | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-451-carcinogenicity-studies_9789264071186-en | Active Substance Part A (chemicals)5.5: Long-term toxicity and carcinogenicity |
5.5: Long-term toxicity and carcinogenicity (283-A) | ||||||
| 636 | OECD Test Guideline 452: Chronic Toxicity Studies | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-452-chronic-toxicity-studies_9789264071209-en | Active Substance Part A (chemicals)5.5: Long-term toxicity and carcinogenicity |
5.5: Long-term toxicity and carcinogenicity (283-A) | ||||||
| 638 | OECD Test Guideline 416: Two-Generation Reproduction Toxicity | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070868-en.pdf?expires=1673879658&id=id&accname=ocid194935&checksum=75B154A2866A5C0C14E17A9B846A18C3 | Active Substance Part A (chemicals)5.6.1: Generational studies |
5.6.1: Generational studies (283-A) | It has been only listed, as it was used in the past. Preference should be given to the EOGRTS. | |||||
| 639 | OECD Test Guideline 414: Prenatal developmental toxicity study | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070820-en.pdf?expires=1673879691&id=id&accname=oid031827&checksum=9DAD07E454CC9B2159633C6B7CF2065E | Active Substance Part A (chemicals)5.6.2: Developmental toxicity studies |
5.6.2: Developmental toxicity studies (283-A) | ||||||
| 640 | OECD Test Guideline 426: Developmental neurotoxicity study | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264067394-en.pdf?expires=1673879712&id=id&accname=ocid194935&checksum=DED9A0FFF5D5360058E6C51DD159F309 | Active Substance Part A (chemicals)5.6.2: Developmental toxicity studies |
5.6.2: Developmental toxicity studies (283-A) | ||||||
| 641 | OECD Test Guideline 424: Neurotoxicity study in rodents | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264071025-en.pdf?expires=1673879775&id=id&accname=ocid194935&checksum=81E323AFAC3AF9255E05172ED880EEAC | Active Substance Part A (chemicals)5.7.1: Neurotoxicity studies in rodents |
5.7.1: Neurotoxicity studies in rodents (283-A) | ||||||
| 642 | OECD Test Guideline 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070905-en.pdf?expires=1673879794&id=id&accname=ocid194935&checksum=9C8B85A4B5C16DFE57B9F07FF62C0EDD | Active Substance Part A (chemicals)5.7.2: Delayed polyneuropathy studies |
5.7.2: Delayed polyneuropathy studies (283-A) | ||||||
| 643 | OECD Test Guideline 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264070929-en.pdf?expires=1673879819&id=id&accname=ocid194935&checksum=CA273525721F88C05E9B4B29B0FCCD47 | Active Substance Part A (chemicals)5.7.2: Delayed polyneuropathy studies |
5.7.2: Delayed polyneuropathy studies (283-A) | ||||||
| 644 | Health Effects Test Guidelines: OPPTS 870.7800 Immunotoxicity [EPA 712–C–98–351] | Yes | N/A | test method | EPA | https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0156-0049 | Active Substance Part A (chemicals)5.8.2: Supplementary studies on the active substance |
5.8.2: Supplementary studies on the active substance (283-A) | Conditional requirement: only if effects indicate immunotoxicological potential observed in toxicological and metabolism studies | |||||
| 679 | OECD Test Guideline 210: Fish, Early-life Stage Toxicity Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264203785-en.pdf?expires=1673884467&id=id&accname=oid031827&checksum=09D95179A7DE394E9975C1724D6875DA | Active Substance Part A (chemicals)8.2.2.1: Fish early life stage toxicity testActive Substance Part B (micro-organisms)8.2.1: Effects on fish |
8.2.2.1: Fish early life stage toxicity test (283-A), 8.2.1: Effects on fish (283-B) | Part B: For micro-organisms, 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 817 | 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 | Yes | Yes | guidance document,
test method |
CANADA | https://publications.gc.ca/collections/collection_2017/eccc/En49-7-1-44-2016-eng.pdf | Active Substance Part B (micro-organisms)8.2: Effects on aquatic organisms8.2.1: Effects on fish |
8.2: Effects on aquatic organisms (283-B), 8.2.1: Effects on fish (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 846 | Test methods according to Section 2.2.4.1. of Part 2 of Annex I, to Regulation (EC) No 1272/2008 | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02008R1272-20231201&qid=1706625887814 | Active Substance Part A (chemicals)2.9: Flammability and self-heatingPPP Part A (chemicals)2.3: Flammability and self-heating |
2.9: Flammability and self-heating (283-A), 2.3: Flammability and self-heating (284-A) | ||||||
| 847 | ISO/IEC 80079-20-1:2017 – Explosive atmospheres - Part 20-1: Material characteristics for gas and vapour classification - Test methods and data | Yes | N/A | test method | - | https://www.iso.org/standard/69556.html | PPP Part A (chemicals)2.3: Flammability and self-heating |
2.3: Flammability and self-heating (284-A) | ||||||
| 848 | Test method according to section 2.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008 | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02008R1272-20231201&qid=1706625887814 | Active Substance Part A (chemicals)2.13: Oxidising propertiesPPP Part A (chemicals)2.2: Explosive and oxidising properties |
2.13: Oxidising properties (283-A), 2.2: Explosive and oxidising properties (284-A) | ||||||
| 849 | OECD Test No. 234: Fish Sexual Development Test | Yes | N/A | test method | - | https://www.oecd-ilibrary.org/docserver/9789264122369-en.pdf?expires=1682088709&id=id&accname=oid031827&checksum=6211E1608E1BE5D00485122C154A68CF | Active Substance Part A (chemicals)8.2.2.1: Fish early life stage toxicity test |
8.2.2.1: Fish early life stage toxicity test (283-A) | ||||||
| 850 | Test L.2: sustained combustibility test, Part III of the UN RTDG Manual of Tests and Criteria | Yes | N/A | test method | UN RTDG | https://unece.org/sites/default/files/2023-11/ST_SG_AC.10_11_Rev.8e_WEB.pdf | Active Substance Part A (chemicals)2.9: Flammability and self-heatingPPP Part A (chemicals)2.3: Flammability and self-heating |
2.9: Flammability and self-heating (283-A), 2.3: Flammability and self-heating (284-A) | ||||||
| 851 | 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 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/env/jm/mono(2000)7/en/pdf | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 853 | Transport of Dangerous Goods (UN RTDG) Manual of Tests and Criteria ST/SG/AC.10/11 | Yes | N/A | test method | UN RTDG | https://unece.org/transport/dangerous-goods/rev7-files | Active Substance Part A (chemicals)2.13: Oxidising properties |
2.13: Oxidising properties (283-A) | ||||||
| 854 | 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)) | Yes | Yes | guidance document | SANTE | https://esdac.jrc.ec.europa.eu/projects/ground-water | Active Substance Part A (chemicals)7.1.2: Rate of degradation in soil7.1.3: Adsorption and desorption in soil Active Substance Part B (micro-organisms)7.2.1: Predicted environmental concentrationPPP Part A (chemicals)9.2.4: Estimation of concentrations in groundwater |
7.1.2: Rate of degradation in soil (283-A), 7.1.3: Adsorption and desorption in soil (283-A), 7.2.1: Predicted environmental concentration (283-B), 9.2.4: Estimation of concentrations in groundwater (284-A) | The generic FOCUS guidance documents that are based on the relevant, more specific guidance documents and regularly updated are listed. | |||||
| 855 | EFSA calculation model Pesticide Residue Intake Model "PRIMo" | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2019.EN-1605 | Active Substance Part A (chemicals)6.9: Estimation of the potential and actual exposure through diet and other sources |
6.9: Estimation of the potential and actual exposure through diet and other sources (283-A) | ||||||
| 637 | OECD Test Guideline 443: Extended One-generation Reproductive Toxicity | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264185371-en.pdf?expires=1673879637&id=id&accname=oid031827&checksum=718F90217ED2321325436A75F7D150EF | Active Substance Part A (chemicals)5.6.1: Generational studies |
5.6.1: Generational studies (283-A) | Existing studies conducted in accordance with OECD TG 416 (adopted 2001 or later) or equivalent information shall be considered appropriate to address this information requirement. But if new test is to be carried out, preference should be given to Extended One-Generation Reproductive Toxicity Study (OECD TG 443). Extended One-Generation Reproductive Toxicity Study (OECD TG 443), with cohorts 1A and 1B and extension of cohort 1B to include the F2 generation with the aim to produce 20 litters per dose group. F2 pups must be followed to weaning and investigated similarly as F1 pups. Rat is the preferred species and oral route of administration is the preferred route. The highest dose level should be based on toxicity and selected with the aim to induce reproductive and/or other systemic toxicity . | |||||
| 725 |
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.
|
Yes | Yes | guidance document | PPP Part A (chemicals)10.2.2: Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms |
10.2.2: Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms (284-A) | According to Section 10.2.2 of Part A of the Annex to Commission Regulation (EU) No 284/2013, the studies referred to in points 8.2.2 and 8.2.5 of Part A of the Annex to Regulation (EU) No 283/2013 must be conducted for particular plant protection products, where it is not possible to extra polate from data obtained in the corresponding studies on the active substance (for example the plant protection product is more acutely toxic than the active substance as manufactured by a factor of 10), unless it is demonstrated that exposure will not occur. | |||||||
| 694 | OECD Test No. 201 Freshwater Alga and Cyanobacteria, Growth Inhibition Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264069923-en.pdf?expires=1673886053&id=id&accname=oid031827&checksum=284B74C8D89A084FAD71174086C94E12 | Active Substance Part A (chemicals)8.2.6.1: Effects on growth of green algae8.2.6.2: Effects on growth of an additional algal species Active Substance Part B (micro-organisms)8.2.3: Effects on algae |
8.2.6.1: Effects on growth of green algae (283-A), 8.2.6.2: Effects on growth of an additional algal species (283-A), 8.2.3: Effects on algae (283-B) | In Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 698 | OECD Test No. 238: Sediment-Free Myriophyllum Spicatum Toxicity Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264224131-en.pdf?expires=1673886115&id=id&accname=oid031827&checksum=F8954CD2028BF429F2F387D853CD2153 | Active Substance Part A (chemicals)8.2.7: Effects on aquatic macrophytesActive Substance Part B (micro-organisms)8.2.4: Effects on aquatic macrophytes |
8.2.7: Effects on aquatic macrophytes (283-A), 8.2.4: Effects on aquatic macrophytes (283-B) | In Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 707 | OECD Guidance Document on Honey Bee Larval Toxicity Test following Repeated Exposure. Series on Testing and Assessment, No. 239 | Yes | N/A | test method | OECD | https://one.oecd.org/document/ENV/JM/MONO(2016)34/en/pdf | Active Substance Part A (chemicals)8.3.1.3: Effects on honeybee development and other honeybee life stagesActive Substance Part B (micro-organisms)8.3: Effects on beesPPP Part A (chemicals)10.3.1.3: Effects on honey bee development and other honey bee life stages |
8.3.1.3: Effects on honeybee development and other honeybee life stages (283-A), 8.3: Effects on bees (283-B), 10.3.1.3: Effects on honey bee development and other honey bee life stages (284-A) | In Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 804 | EPPO Bulletin (2010) 40 Side-Effects On Honeybees | Yes | N/A | test method | EPPO | https://pp1.eppo.int/standards/PP1-170-4 | Active Substance Part B (micro-organisms)8.3: Effects on bees |
8.3: Effects on bees (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 702 | OECD Test No. 247 Bumblebee, Acute Oral Toxicity Test | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264284128-en.pdf?expires=1673886177&id=id&accname=oid031827&checksum=A42DF4CDAC1A58869D031EF61D0EC7F9 | Active Substance Part A (chemicals)8.3.1.1.1: Acute oral toxicityActive Substance Part B (micro-organisms)8.3: Effects on beesPPP Part A (chemicals)10.3.1.1.1: Acute oral toxicity |
8.3.1.1.1: Acute oral toxicity (283-A), 8.3: Effects on bees (283-B), 10.3.1.1.1: Acute oral toxicity (284-A) | In Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 824 | 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 | Yes | Yes | guidance document,
test method |
CANADA | https://publications.gc.ca/collections/collection_2017/eccc/En49-7-1-44-2016-eng.pdf | Active Substance Part B (micro-organisms)8.4: Effects on non-target arthropods other than bees |
8.4: Effects on non-target arthropods other than bees (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 937 |
Test guidelines are listed in OECD Revised Guidance Document No. 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption.
|
Yes | N/A | test method | OECD | Active Substance Part A (chemicals)8.1.5: Endocrine disrupting properties8.2.3: Endocrine disrupting properties |
8.1.5: Endocrine disrupting properties (283-A), 8.2.3: Endocrine disrupting properties (283-A) | |||||||
| 957 | OECD Test Guideline 442D: In Vitro Skin Sensitisation | Yes | N/A | test method | OECD | https://www.oecd.org/env/test-no-442d-in-vitro-skin-sensitisation-9789264229822-en.htm#:~:text=This%20Test%20Guideline%20(TG)%20provides,accordance%20with%20the%20UN%20GHS. | PPP Part B (micro-organisms)7.3.6: Skin sensitisation |
7.3.6: Skin sensitisation (284-B) | ||||||
| 958 | 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 | Yes | N/A | test method | OECD | https://www.oecd.org/env/test-no-442e-in-vitro-skin-sensitisation-9789264264359-en.htm | PPP Part B (micro-organisms)7.3.6: Skin sensitisation |
7.3.6: Skin sensitisation (284-B) | ||||||
| 402 | EPPO standard series PP1: Efficacy evaluation of plant protection products | Yes | Yes | guidance document,
test method |
EPPO | https://pp1.eppo.int/ | Active Substance Part A (chemicals)3: Further information on the active substancePPP Part A (chemicals)6: Efficacy data |
3: Further information on the active substance (283-A), 6: Efficacy data (284-A) | Please consider only those uses which are deemed relevant under the scope of Reg (EC) No 1107/2009, and not those in EPPO PP1/248 which refer to biostimulant claims as defined both under the scope of Reg (EU) No 2019/1009 and under the technical specifications CEN/TS 17724, CEN/TS 17700-1, CEN/TS 17700-2, CEN/TS 17700-3, CEN/TS 17700-4, CEN/TS 17700-5, even if these biostimulants are identified as plant growth regulators in EPPO PP1/248. | in case of the Communication 283/2013, it is listed as test method, in case of the Communication 284/2013 as guidance document and test method | ||||
| 1035 | 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. | Yes | N/A | test method | https://iobc-wprs.org/product/guidelines-to-evaluate-side-effects-of-plant-protection-products-to-non-target-arthropods/ | Active Substance Part A (chemicals)8.3.2.1: Effects on Aphidius rhopalosiphi8.3.2.2: Effects on Typhlodromus pyri |
8.3.2.1: Effects on Aphidius rhopalosiphi (283-A), 8.3.2.2: Effects on Typhlodromus pyri (283-A) | |||||||
| 761 | CIPAC Method MT 36: Emulsion characteristics of emulsifiable concentrates | Yes | N/A | test method | CIPAC | https://www.cipac.org/index.php/component/content/article/104-mt-36-3-emulsion-characteristics-of-emulsifiable-concentrates?catid=2:uncategorised&Itemid=210 | PPP Part A (chemicals)2.8.6: Emulsifiability, re-emulsifiability, emulsion stabilityPPP Part B (micro-organisms)2.7.6: Emulsifiability, re-emulsifiability and emulsion stability |
2.8.6: Emulsifiability, re-emulsifiability, emulsion stability (284-A), 2.7.6: Emulsifiability, re-emulsifiability and emulsion stability (284-B) | ||||||
| 719 | OECD Test No. 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test | Yes | N/A | guidance document,
test method |
OECD | https://www.oecd-ilibrary.org/docserver/9789264070066-en.pdf?expires=1673954914&id=id&accname=ocid194935&checksum=4AE7F0A89C98566A98A84410833E932D | Active Substance Part A (chemicals)8.6.2: Testing on non-target plantsActive Substance Part B (micro-organisms)8.6: Effects on non-target terrestrial plantsPPP Part A (chemicals)10.6.2: Testing on non-target plantsPPP Part B (micro-organisms)6.6.1: Impact on succeeding crops6.6.2: Impact on other plants, including adjacent crops |
8.6.2: Testing on non-target plants (283-A), 8.6: Effects on non-target terrestrial plants (283-B), 10.6.2: Testing on non-target plants (284-A), 6.6.1: Impact on succeeding crops (284-B), 6.6.2: Impact on other plants, including adjacent crops (284-B) | Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | In 284-B, it is a GD under 6.6.2, and a test method under 6.6.1. In 283-B, it is a test method under 8.6. In 283-A, it is test method under 8.6.2.Testing on non-target plants - seedling emergence and seedling growth In 284-A, it is test method under 10.6.2.Testing on non-target plants - seedling emergence and seedling growth | ||||
| 590 | OECD Test Guideline 433: Acute Inhalation Toxicity: Fixed Concentration Procedure | Yes | N/A | test method | OECD | https://www.oecd.org/env/ehs/testing/test-no-433-acute-inhalation-toxicity-fixed-concentration-procedure-9789264284166-en.htm | Active Substance Part A (chemicals)5.2.3: InhalationPPP Part A (chemicals)7.1.3: Inhalation toxicity |
5.2.3: Inhalation (283-A), 7.1.3: Inhalation toxicity (284-A) | ||||||
| 821 | 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 | Yes | Yes | guidance document,
test method |
CANADA | https://publications.gc.ca/collections/collection_2017/eccc/En49-7-1-44-2016-eng.pdf | Active Substance Part B (micro-organisms)8.2.2: Effects on aquatic invertebrates |
8.2.2: Effects on aquatic invertebrates (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 1055 | EU Explanatory notes for the implementation of the data requirements on micro-organisms and plant protection products containing them in the framework of Reg. (EC) No 1107/2009 (PAFF-PPL-October 2023-Doc.A.07.01) | to be listed | Yes | guidance document | SANTE | General | https://food.ec.europa.eu/system/files/2023-10/pesticides_ppp_app-proc_guide_imp-data-req_micro-organisms-ppp_imp-reg-11072009.pdf | |||||||
| 555 | List of obsolete Guidance Documents | No | N/A | supporting document | SANTE | https://food.ec.europa.eu/system/files/2023-06/pesticides_ppp_app-list-obselete-guid-docs.pdf | ||||||||
| 1116 | ISO 18400-104:2018 | Yes | N/A | test method | ISO | https://www.iso.org/standard/65223.html | Active Substance Part A (chemicals)7.1: Fate and behaviour in soilPPP Part A (chemicals)9.1: Fate and behaviour in soil |
7.1: Fate and behaviour in soil (283-A), 9.1: Fate and behaviour in soil (284-A) | ||||||
| 1136 | Notification according to Art. 36(3) of Regulation (EC) No 1107/2009 (SANCO/10532/2013) | No | N/A | supporting document | COM | Procedural guidance document- post approval issues | https://food.ec.europa.eu/document/download/e4b77678-1fad-4c9e-8d36-b67878b7db00_en?filename=pesticides_aas_guidance_notification_art_36_3_en.doc | |||||||
| 1137 | Template to notify intended zonal applications under Article 33 of Regulation (EC) No 1107/2009 (SANCO/12544/2014) | No | N/A | supporting document | COM | Procedural guidance document- post approval issues | https://food.ec.europa.eu/document/download/fb9ea88b-7fb9-44a0-a7d4-4e0ad81abc42_en?filename=pesticides_aas_guidance_template_notification_form.doc | |||||||
| 548 | Guidance document on a process for intra & inter-zonal work-sharing to facilitate the registration and re-registration of plant protection products following inclusion of an active substance in Annex I of Council Directive 91/414/EEC (SANCO/6896/2009) | No | Yes | guidance document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/system/files/2016-10/pesticides_aas_guidance_intra-inter-zonal-worksharing_sanco-6896-2009.pdf | |||||||
| 1139 | Guidance document on the procedures for submission and assessment of confirmatory information following approval of an active substance in accordance with Regulation (EC) No 1107/2009 (SANCO/5634/2009) | No | No | guidance document | COM | Procedural guidance document- post approval issues | https://food.ec.europa.eu/document/download/d962a879-0571-4616-ac92-4ef43e518a3a_en?filename=pesticides_aas_guidance_confirmatory-data_rev6-1_201312_en.pdf | |||||||
| 481 | Outcome of pesticides peer review meeting on recurring issues in ecotoxicology | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/supporting/pub/en-924 | ||||||||
| 1195 | Guidance document on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water (PAFF-PPL-March 2024-Doc.A.07.03) | to be listed | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8194 | https://food.ec.europa.eu/document/download/8829c80e-4576-4548-b0e6-ba54b09af225_en?filename=pesticides_ppp_app-proc_guide_fate_impact-water-treatment.pdf | |||||||
| 1255 | Compendium of conditions of use to reduce exposure and risk from plant protection products (PAFF-PPL-March 2024-Doc.A.07.02) | No | Yes | guidance document | COMMISSION | https://food.ec.europa.eu/document/download/cdd9b6c4-29dc-4077-a118-3e51c0abeb80_en?filename=pesticides_ppp_app-proc_guide_horiz_comp-cond.pdf | ||||||||
| 490 | EFSA Guidance on aneugenicity assessment (PAFF-PPL-May22-Doc.A.07.02, EFSA Journal 2021;19(8):6770) | Yes | Yes | guidance document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/6770 | https://food.ec.europa.eu/document/download/f83d82c9-f819-4181-8e31-66c26d1ce854_en?filename=pesticides_ppp_app-proc_guide_tox_aneug-assess_2022.pdf | Active Substance Part A (chemicals)5.4: Genotoxicity testing |
5.4: Genotoxicity testing (283-A) | |||||
| 915 | 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. | Yes | N/A | test method | EPPO | https://doi.org/10.1111/epp.12553 | Active Substance Part A (chemicals)8.3.1.3: Effects on honeybee development and other honeybee life stagesPPP Part A (chemicals)10.3.1.3: Effects on honey bee development and other honey bee life stages10.3.1.6: Field tests with honeybees |
8.3.1.3: Effects on honeybee development and other honeybee life stages (283-A), 10.3.1.3: Effects on honey bee development and other honey bee life stages (284-A), 10.3.1.6: Field tests with honeybees (284-A) | ||||||
| 831 | US EPA OCSPP 885.4380 Honey bee Tier I | Yes | N/A | test method | EPA | https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0159-0037 | Active Substance Part B (micro-organisms)8.3: Effects on bees |
8.3: Effects on bees (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 832 | US EPA OCSPP 885.4340 Non-target Insect Tier I | Yes | N/A | test method | EPA | https://nepis.epa.gov/Exe/ZyNET.exe/P100I7AM.TXT?ZyActionD=ZyDocument&Client=EPA&Index=1995+Thru+1999&Docs=&Query=&Time=&EndTime=&SearchMethod=1&TocRestrict=n&Toc=&TocEntry=&QField=&QFieldYear=&QFieldMonth=&QFieldDay=&IntQFieldOp=0&ExtQFieldOp=0&XmlQuery=&File=D%3A%5Czyfiles%5CIndex%20Data%5C95thru99%5CTxt%5C00000034%5CP100I7AM.txt&User=ANONYMOUS&Password=anonymous&SortMethod=h%7C-&MaximumDocuments=1&FuzzyDegree=0&ImageQuality=r75g8/r75g8/x150y150g16/i425&Display=hpfr&DefSeekPage=x&SearchBack=ZyActionL&Back=ZyActionS&BackDesc=Results%20page&MaximumPages=1&ZyEntry=1&SeekPage=x&ZyPURL | Active Substance Part B (micro-organisms)8.4: Effects on non-target arthropods other than bees |
8.4: Effects on non-target arthropods other than bees (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 720 | OECD Test No. 227 : Terrestrial Plant Test: Vegetative Vigour Test | Yes | Yes | guidance document,
test method |
OECD | https://read.oecd-ilibrary.org/environment/test-no-227-terrestrial-plant-test-vegetative-vigour-test_9789264067295-en#page1 | Active Substance Part A (chemicals)8.6.2: Testing on non-target plantsActive Substance Part B (micro-organisms)8.6: Effects on non-target terrestrial plantsPPP Part A (chemicals)10.6.2: Testing on non-target plantsPPP Part B (micro-organisms)6.6.2: Impact on other plants, including adjacent crops |
8.6.2: Testing on non-target plants (283-A), 8.6: Effects on non-target terrestrial plants (283-B), 10.6.2: Testing on non-target plants (284-A), 6.6.2: Impact on other plants, including adjacent crops (284-B) | Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | In 283-A, it is a test method under 8.2.6. In 284-A, it is a test method under 10.6.2. In 283-B, it is a guidance document under 6.6.2. In 284-B, it is a test method under 6.6.2. | ||||
| 956 | OECD Test Guideline 442C: In Chemico Skin Sensitisation | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-442c-in-chemico-skin-sensitisation_9789264229709-en | PPP Part B (micro-organisms)7.3.6: Skin sensitisation |
7.3.6: Skin sensitisation (284-B) | ||||||
| 996 | ISO 11268-3:2014: Soil quality - Effects of pollutants on earthworms -- Part 3: Guidance on the determination of effects in field situations | Yes | N/A | test method | ISO | https://www.iso.org/standard/57583.html | Active Substance Part A (chemicals)8.4.1: Earthworm — sub-lethal effectsPPP Part A (chemicals)10.4.1.2: Earthworms — field studies |
8.4.1: Earthworm — sub-lethal effects (283-A), 10.4.1.2: Earthworms — field studies (284-A) | ||||||
| 1075 | EU Technical guidelines on the presentation and evaluation of plant protection product dossiers in the format of a (draft) Registration Report (SANCO/6895/2009) | to be listed | Yes | guidance document | SANTE | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/document/download/cec5c62c-7753-4f5b-99db-3e40774d1933_en?filename=pesticides_ppp_app-proc_guide_doss_drr.zip | guidance document: https://food.ec.europa.eu/document/download/c30b9158-5f9f-46f4-8df3-e103720b4f42_en?filename=pesticides_ppp_app-proc_guide_doss_drr-20091002.pdf | ||||||
| 1115 | ISO 18400-102:2017 | Yes | N/A | test method | ISO | https://www.iso.org/standard/62843.html | Active Substance Part A (chemicals)7.1: Fate and behaviour in soilPPP Part A (chemicals)9.1: Fate and behaviour in soil |
7.1: Fate and behaviour in soil (283-A), 9.1: Fate and behaviour in soil (284-A) | ||||||
| 483 | Scientific Opinion on the state of the art of TKTD effect models for regulatory risk assessment of pesticides for aquatic organisms´ (EFSA Journal 2018;16(8):5377) | No | N/A | supporting document | EFSA | https://www.efsa.europa.eu/en/efsajournal/pub/5377 | ||||||||
| 508 | OECD (2012) PERFORMANCE STANDARDS FOR STABLY TRANSFECTED TRANSACTIVATION IN VITRO ASSAYS TO DETECT ESTROGEN RECEPTOR ANTAGONISTS Series on Testing & Assessment No. 174 – Second edition ENV/JM/MONO(2012)19/REV1 | No | N/A | supporting document | OECD | https://web-archive.oecd.org/2015-10-29/377095-19_REV1.pdf | ||||||||
| 329 | 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) | Yes | Yes | guidance document | EFSA | https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2022.7032 | https://food.ec.europa.eu/system/files/2022-08/pesticides_ppp_app-proc_guide_tox_accpt-exp-levs-2015.pdf | Active Substance Part A (chemicals)5: Toxicological and metabolism studiesPPP Part A (chemicals)7.2: Data on exposurePPP Part B (micro-organisms)7.2: Assessment of potential toxicity of the plant protection product7.5: Data on exposure |
5: Toxicological and metabolism studies (283-A), 7.2: Data on exposure (284-A), 7.2: Assessment of potential toxicity of the plant protection product (284-B), 7.5: Data on exposure (284-B) | link to the EFSA document: https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2022.7032 | ||||
| 1235 | Proposed priority list for development and updates of guidance documents (in the context of Regulations (EC) No 1107/2009 and Regulation (EC) No 396/2005) PAFF-PPL-Jan 2023-Doc.A.07.01.b | No | Yes | guidance document | COM | https://food.ec.europa.eu/document/download/f383f32c-1e42-468c-a70a-85cc51337fe4_en?filename=pesticides_ppp_app-list-guidance_priority-list.pdf | ||||||||
| 822 | 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 | Yes | Yes | guidance document,
test method |
CANADA | https://publications.gc.ca/collections/collection_2017/eccc/En49-7-1-44-2016-eng.pdf | Active Substance Part B (micro-organisms)8.2.3: Effects on algae |
8.2.3: Effects on algae (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 699 | OECD Test No. 239: Water-Sediment Myriophyllum Spicatum Toxicity Test | Yes | N/A | test method | OECD | https://read.oecd-ilibrary.org/environment/test-no-239-water-sediment-myriophyllum-spicatum-toxicity-test_9789264224155-en#page1 | Active Substance Part A (chemicals)8.2.7: Effects on aquatic macrophytesActive Substance Part B (micro-organisms)8.2.4: Effects on aquatic macrophytes |
8.2.7: Effects on aquatic macrophytes (283-A), 8.2.4: Effects on aquatic macrophytes (283-B) | In Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 803 | EPPO Bulletin (2019) 49 Oomen Bee Brood Feeding Test | Yes | N/A | test method | EPPO | https://onlinelibrary.wiley.com/toc/13652338/2019/49/1 | Active Substance Part B (micro-organisms)8.3: Effects on bees |
8.3: Effects on bees (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 777 | EPPO Standard PP1/292: Cleaning pesticide application equipment (PAE) – efficacy aspects | Yes | Yes | guidance document,
test method |
EPPO | https://pp1.eppo.int/standards/PP1-292-1 | PPP Part A (chemicals)4: Further information on the plant protection productPPP Part B (micro-organisms)4.1: Procedures for cleaning and decontaminating of application equipment |
4: Further information on the plant protection product (284-A), 4.1: Procedures for cleaning and decontaminating of application equipment (284-B) | referred as guidance document in the Communication 284/2013 Part B and as test method in the Communication 284/2013 Part A | |||||
| 995 |
Where relevant, same test methods as reported in Section 6 of the Annex II to Commission Communication C(2023) 6245
|
Yes | N/A | test method | PPP Part A (chemicals)8: Residues in or on treated products, food and feed |
8: Residues in or on treated products, food and feed (284-A) | According to Section 8 of Part A of the Annex to Commission Regulation (EU) No 284/2013, data and information on residues in or on treated products, food and feed in accordance with Section 6 of Part A of the Annex to Regulation (EU) No 283/2013 must be submitted, unless the applicant shows that the data and information already submitted for the active substance can be applied. | |||||||
| 1015 |
Please refer to 7.1.1.
|
Yes | N/A | test method | PPP Part A (chemicals)10.1.2.1: Acute oral toxicity to mammals |
10.1.2.1: Acute oral toxicity to mammals (284-A) | ||||||||
| 1016 |
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.
|
Yes | N/A | test method | PPP Part A (chemicals)10.2.1: Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes |
10.2.1: Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes (284-A) | According to Section 10.2.1. of Part A of the Annex to Commission Regulation (EU) No 284/2013, tests shall be carried out on one species from each of the three/four groups of aquatic organisms, that is to say fish, aquatic invertebrates, algae and, where relevant, macrophytes as referred to in point 8.2 of Part A of the Annex to Regulation (EU) No 283/2013, if the plant protection product itself may contaminate water. | |||||||
| 1017 |
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.
|
Yes | N/A | test method | PPP Part A (chemicals)10.2.2: Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms |
10.2.2: Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms (284-A) | According to section 10.2.2 Part A of the Annex to Commission Regulation (EU) No 284/2013, the studies referred to in points 8.2.2 and 8.2.5 of Part A of the Annex to Regulation (EU) No 283/2013 must be conducted for particular plant protection products, where it is not possible to extra polate from data obtained in the corresponding studies on the active substance (for example the plant protection product is more acutely toxic than the active substance as manufactured by a factor of 10), unless it is demonstrated that exposure will not occur. | |||||||
| 565 | OECD Test Guideline 107: Partition coefficient, shake-flask method | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-107-partition-coefficient-n-octanol-water-shake-flask-method_9789264069626-en#:~:text=Test%20No.%20107%3A%20Partition%20Coefficient%20%28n-octanol%2Fwater%29%3A%20Shake%20Flask,method%20can%20not%20be%20used%20with%20surface-active%20materials. | Active Substance Part A (chemicals)2.7: Partition coefficient n-octanol/water |
2.7: Partition coefficient n-octanol/water (283-A) | If a compound is surface active (as defined by OECD 115 Surface tension) the shake-flask method described in OECD 107 can be applicable if in the report it is clear that no problems occurred (e.g. phase separations). The HPLC method described in OECD 107 is not applicable to surface active compounds. | |||||
| 535 | Template to be used for assessment reports regarding level 3 of volume 1 (SANCO/11114/2012) | No | N/A | supporting document | SANTE | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/document/download/63d3a8a9-f4c9-4c22-90f0-4398edcde86b_en?filename=pesticides_ppp_app-proc_guide_doss_temp-assess-rprts_lvl-3-v1.pdf | word document: https://food.ec.europa.eu/document/download/275de12b-9a7d-4e4a-a474-d1191c1a0bff_en?filename=pesticides_ppp_app-proc_guide_doss_temp-assess-rprts_lvl-3-v1.doc | ||||||
| 442 | Good Laboratory Practice (GLP) | No | No | COM | Procedural guidance document- dossier and draft assessment report | https://food.ec.europa.eu/document/download/888eba25-f5ae-4b66-b17a-92c7e4f6bef8_en?filename=pesticides_ppp_app-proc_guide_doss_glp_7017-vi-95.pdf | ||||||||
| 1135 | Notification according to Art. 44(4) of Regulation (EC) 1107/2009 (SANCO-2012-12293) | No | N/A | supporting document | COM | Procedural guidance document- post approval issues | https://food.ec.europa.eu/document/download/df17968f-3a74-4dc5-9b0e-ed6245729c8a_en?filename=pesticides_aas_notification_2012-12293.docx | |||||||
| 1138 | Guidance Document on the renewal of active substances included in Annex I of Council Directive 91/414/EEC to be assessed in compliance with Regulation 1141/2010 (the renewal regulation) (SANCO/10387/2010) | No | N/A | guidance document | Procedural guidance document- post approval issues | https://food.ec.europa.eu/document/download/7d72a8b5-fc06-4f1c-b53c-6a3205d07978_en?filename=pesticides_aas_guidance_air_2_rev_8102010.pdf | ||||||||
| 519 | ECHA, 2013. Grouping of substances and read across approach | No | N/A | supporting document | ECHA | https://echa.europa.eu/support/registration/how-to-avoid-unnecessary-testing-on-animals/grouping-of-substances-and-read-across | ||||||||
| 1155 | CIPAC code numbers | No | N/A | supporting document | https://www.cipac.org/index.php/code-numbers/navigate-code-numbers | |||||||||
| 716 | OECD Test Guideline 232: Collembolan Reproduction Test in Soil | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/9789264264601-en.pdf?expires=1673954781&id=id&accname=oid031827&checksum=462061CD80A72FFAA6072F1E0D38E782 | Active Substance Part A (chemicals)8.4.2.1: Species level testingActive Substance Part B (micro-organisms)8.5: Effects on non-target meso- and macro-organisms in soilPPP Part A (chemicals)10.4.2.1: Species level testing |
8.4.2.1: Species level testing (283-A), 8.5: Effects on non-target meso- and macro-organisms in soil (283-B), 10.4.2.1: Species level testing (284-A) | In Part B of the Communication 283/2013: 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 935 | 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 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/env/jm/mono(2010)15/en/pdf | Active Substance Part A (chemicals)5.8.2: Supplementary studies on the active substance |
5.8.2: Supplementary studies on the active substance (283-A) | ||||||
| 936 | 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 | Yes | N/A | test method | ECHA | https://echa.europa.eu/documents/10162/13632/information_requirements_r8_en.pdf/e153243a-03f0-44c5-8808-88af66223258 | Active Substance Part A (chemicals)5.3: Short-term toxicity |
5.3: Short-term toxicity (283-A) | ||||||
| 955 | Specific Standards of the EPPO standard series PP1 | Yes | N/A | test method | EPPO | http://pp1.eppo.org/ | PPP Part B (micro-organisms)6: Efficacy data |
6: Efficacy data (284-B) | EPPO standards of series PP1 describe how to evaluate the efficacy of plant protection products. The series contain General Standards and Specific Standards. Specific Standards should be used together with relevant General Standards and vice versa. | |||||
| 975 | Test methods according to Part III of the UN RTDG Manual of Tests and Criteria | Yes | N/A | test method | - | https://unece.org/sites/default/files/2023-11/ST_SG_AC.10_11_Rev.8e_WEB.pdf | PPP Part A (chemicals)2.4: Acidity/alkalinity and pH value |
2.4: Acidity/alkalinity and pH value (284-A) | ||||||
| 561 | OECD Test Guideline 105: Water Solubility | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/environment/test-no-105-water-solubility_9789264069589-en#:~:text=Test%20No.%20105%3A%20Water%20Solubility%20This%20Test%20Guideline,the%20substance%20in%20water%20at%20a%20given%20temperature. | Active Substance Part A (chemicals)2.5: Solubility in water2.6: Solubility in organic solvents |
2.5: Solubility in water (283-A), 2.6: Solubility in organic solvents (283-A) | in case of section 2.6 of Communication 283/2013: may be adapted in some circumstances | |||||
| 762 | CIPAC Method MT 172: Flowability of granular preparations after accelerated storage under pressure | Yes | N/A | test method | CIPAC | https://www.bing.com/ck/a?!&&p=682c30420ed74388JmltdHM9MTY5NTY4NjQwMCZpZ3VpZD0zOTRiNjVhOC0xMGU2LTY5MmItMDE5Ny03NmJiMTE5NDY4ZTImaW5zaWQ9NTQ2MA&ptn=3&hsh=3&fclid=394b65a8-10e6-692b-0197-76bb119468e2&psq=CIPAC+Method+MT+172%3a+Flowability+of+granular+preparations+after+accelerated+storage+under+pressure&u=a1aHR0cHM6Ly9jaXBhYy5vcmcvaW1hZ2VzL21lbWJlcnMtYXJlYS8yMDE4LzUxNTVtX0NJUEFDJTIwTVRfMTcyXzJfdjEyX2ZpbmFsX0Zsb3dhYmlsaXR5LmRvY3gjOn46dGV4dD1PVVRMSU5FJTIwT0YlMjBNRVRIT0QlMjBBZnRlciUyMGFjY2VsZXJhdGVkJTIwc3RvcmFnZSUyMHVuZGVyJTIwYSxpcyUyMGFwcGxpZWQlMjB0byUyMGRldGVybWluZSUyMHRoZSUyMGZsb3dhYmlsaXR5JTIwYWZ0ZXIlMjB0YXBwaW5nLg&ntb=1 | PPP Part A (chemicals)2.8.7: Flowability, pourability and dustabilityPPP Part B (micro-organisms)2.7.7: Flowability, pourability (rinsability) and dustability |
2.8.7: Flowability, pourability and dustability (284-A), 2.7.7: Flowability, pourability (rinsability) and dustability (284-B) | ||||||
| 1056 | OECD Guidance document on Baculoviruses as plant protection products Series on Pesticides No. 111 | to be listed | No | guidance document | OECD | General | https://one.oecd.org/document/ENV/CBC/MONO(2023)21/en/pdf | |||||||
| 1117 | ISO 18400-105:2017 | Yes | N/A | test method | ISO | https://www.iso.org/standard/62364.html | Active Substance Part A (chemicals)7.1: Fate and behaviour in soilPPP Part A (chemicals)9.1: Fate and behaviour in soil |
7.1: Fate and behaviour in soil (283-A), 9.1: Fate and behaviour in soil (284-A) | ||||||
| 1140 | Guidance to provide justifications as referred in point 1.5 of the Introduction of the Annexes of Regulations (EU) No 283/2013 and No 284/2013: Problem formulation for environmental risk assessment in the context of Regulation (EC) No 1107/2009 (PAFF-PPL-January 2024-Doc.A.07.01) | to be listed | Yes | guidance document | COM | https://food.ec.europa.eu/document/download/c4d6b7df-b7f9-4b3b-8ce5-b823ccdcf98c_en?filename=pesticides_ppp_app-proc_guide_horiz_problem-formulation-era.pdf | template word document is available: https://food.ec.europa.eu/document/download/08d45dfa-48bc-499a-97e7-0d895dae7fff_en?filename=pesticides_ppp_app-proc_guide_horiz_problem-formulation-era_template.docx | |||||||
| 546 | Guidance on the evaluation of new active substance data post (renewal of) approval (SANCO/10328/2004) | No | No | guidance document | SANTE | Procedural guidance document- post approval issues | https://food.ec.europa.eu/document/download/fe0e4302-6c28-4927-851c-ab7903ae55b5_en?filename=pesticides_aas_guidance_annex2_10328-2004.pdf | |||||||
| 1177 | Mode of Action of Microbial Biological Control Agents Against Plant Diseases: Relevance Beyond Efficacy (2019). Front Plant Sci. 2019; 10: 845. | No | N/A | supporting document | - | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6658832/ | ||||||||
| 1215 | OECD Working Document on the Risk Assessment of Secondary Metabolites of Microbial Biocontrol Agents Series on Pesticides No. 98 | No | N/A | supporting document | OECD | https://one.oecd.org/document/env/jm/mono(2018)33/en/pdf | ||||||||
| 806 | OECD Guidance document on storage stability of microbial pest control products. Series on Pesticides No. 85 (ENV/JM/MONO(2016)54) | Yes | Yes | guidance document | OECD | https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2016)54&doclanguage=en | PPP Part B (micro-organisms)2.6: Storage stability and shelf life |
2.6: Storage stability and shelf life (284-B) | ||||||
| 826 | 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 | Yes | Yes | guidance document,
test method |
CANADA | https://publications.gc.ca/collections/collection_2017/eccc/En49-7-1-44-2016-eng.pdf | Active Substance Part B (micro-organisms)8.5: Effects on non-target meso- and macro-organisms in soil |
8.5: Effects on non-target meso- and macro-organisms in soil (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 827 | 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 | Yes | Yes | guidance document,
test method |
CANADA | https://publications.gc.ca/collections/collection_2017/eccc/En49-7-1-44-2016-eng.pdf | Active Substance Part B (micro-organisms)8.6: Effects on non-target terrestrial plants |
8.6: Effects on non-target terrestrial plants (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 828 | US EPA 885.4000 (1996) Background for non-target organism testing of microbial pest control agents | Yes | Yes | guidance document | EPA | https://nepis.epa.gov/Exe/ZyNET.exe/P100I78P.TXT?ZyActionD=ZyDocument&Client=EPA&Index=1995+Thru+1999&Docs=&Query=&Time=&EndTime=&SearchMethod=1&TocRestrict=n&Toc=&TocEntry=&QField=&QFieldYear=&QFieldMonth=&QFieldDay=&IntQFieldOp=0&ExtQFieldOp=0&XmlQuery=&File=D%3A%5Czyfiles%5CIndex%20Data%5C95thru99%5CTxt%5C00000034%5CP100I78P.txt&User=ANONYMOUS&Password=anonymous&SortMethod=h%7C-&MaximumDocuments=1&FuzzyDegree=0&ImageQuality=r75g8/r75g8/x150y150g16/i425&Display=hpfr&DefSeekPage=x&SearchBack=ZyActionL&Back=ZyActionS&BackDesc=Results%20page&MaximumPages=1&ZyEntry=1&SeekPage=x&ZyPURL | Active Substance Part B (micro-organisms)8: Ecotoxicological studies |
8: Ecotoxicological studies (283-B) | ||||||
| 829 | US EPA OCSPP 885.4200 freshwater fish Tier I | Yes | N/A | test method | EPA | https://nepis.epa.gov/Exe/ZyNET.exe/P100I79V.TXT?ZyActionD=ZyDocument&Client=EPA&Index=1995+Thru+1999&Docs=&Query=&Time=&EndTime=&SearchMethod=1&TocRestrict=n&Toc=&TocEntry=&QField=&QFieldYear=&QFieldMonth=&QFieldDay=&IntQFieldOp=0&ExtQFieldOp=0&XmlQuery=&File=D%3A%5Czyfiles%5CIndex%20Data%5C95thru99%5CTxt%5C00000034%5CP100I79V.txt&User=ANONYMOUS&Password=anonymous&SortMethod=h%7C-&MaximumDocuments=1&FuzzyDegree=0&ImageQuality=r75g8/r75g8/x150y150g16/i425&Display=hpfr&DefSeekPage=x&SearchBack=ZyActionL&Back=ZyActionS&BackDesc=Results%20page&MaximumPages=1&ZyEntry=1&SeekPage=x&ZyPURL | Active Substance Part B (micro-organisms)8.2.1: Effects on fish |
8.2.1: Effects on fish (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 830 | US EPA OCSPP 885.4300 Non target plant studies Tier I | Yes | N/A | test method | EPA | https://nepis.epa.gov/Exe/ZyNET.exe/P100I7AG.TXT?ZyActionD=ZyDocument&Client=EPA&Index=1995+Thru+1999&Docs=&Query=&Time=&EndTime=&SearchMethod=1&TocRestrict=n&Toc=&TocEntry=&QField=&QFieldYear=&QFieldMonth=&QFieldDay=&IntQFieldOp=0&ExtQFieldOp=0&XmlQuery=&File=D%3A%5Czyfiles%5CIndex%20Data%5C95thru99%5CTxt%5C00000034%5CP100I7AG.txt&User=ANONYMOUS&Password=anonymous&SortMethod=h%7C-&MaximumDocuments=1&FuzzyDegree=0&ImageQuality=r75g8/r75g8/x150y150g16/i425&Display=hpfr&DefSeekPage=x&SearchBack=ZyActionL&Back=ZyActionS&BackDesc=Results%20page&MaximumPages=1&ZyEntry=1&SeekPage=x&ZyPURL | Active Substance Part B (micro-organisms)8.2.3: Effects on algae |
8.2.3: Effects on algae (283-B) | 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, must be justified in light of the biological and ecological characteristics of the active substance to be assessed and it may be discussed in pre-submission meetings. | |||||
| 835 | Process for prioritisation of development and updates of guidance documents (in the context of Regulations (EC) No 1107/2009 and Regulation (EC) No 396/2005) PAFF-PPL-Jan 2023-Doc.A.07.01.a | No | Yes | guidance document | COM | https://food.ec.europa.eu/system/files/2023-08/pesticides_ppp_app-list-guidance_priority-list-process.pdf | ||||||||
| 837 | ECHA. Read-Across Assessment Framework (RAAF), ECHA-17-R-01-EN | Yes | Yes | guidance document | ECHA | https://echa.europa.eu/documents/10162/13628/raaf_en.pdf/614e5d61-891d-4154-8a47-87efebd1851a | Active Substance Part A (chemicals)0: General GuidancePPP Part A (chemicals)0: General Guidance |
0: General Guidance (283-A), 0: General Guidance (284-A) | ||||||
| 838 | 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 | Yes | Yes | guidance document | ICH | https://www.fda.gov/regulatory-information/search-fda-guidance-documents/s3a-guidance-note-guidance-toxicokinetics-assessment-systemic-exposure-toxicity-studies-focus | Active Substance Part A (chemicals)5.1: Studies on absorption, distribution, metabolism and excretion in mammals |
5.1: Studies on absorption, distribution, metabolism and excretion in mammals (283-A) | ||||||
| 839 | OECD Guidance document on inhalation toxicity studies. Series on testing and assessment, No. 39 | Yes | Yes | guidance document | OECD | https://one.oecd.org/document/env/jm/mono(2009)28/rev1/en/pdf | Active Substance Part A (chemicals)5.2.3: InhalationPPP Part A (chemicals)7.1.3: Inhalation toxicity |
5.2.3: Inhalation (283-A), 7.1.3: Inhalation toxicity (284-A) | ||||||
| 840 | Method A.23 Partition coefficient (1-octanol/water): Slow stirring method, Part A of Commission Regulation (EC) No 440/2008 | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.7: Partition coefficient n-octanol/water |
2.7: Partition coefficient n-octanol/water (283-A) | ||||||
| 841 | Method A.24 Partition coefficient (n-octanol/water), High performance liquid chromatography (HPLC) method, Part A of Commission Regulation (EC) No 440/2008 | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.7: Partition coefficient n-octanol/water |
2.7: Partition coefficient n-octanol/water (283-A) | ||||||
| 842 | Method A.5 Surface tension, (Annex of Commission Regulation (EC) No 440/2008) | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.12: Surface tensionPPP Part A (chemicals)2.5: Viscosity and surface tension |
2.12: Surface tension (283-A), 2.5: Viscosity and surface tension (284-A) | ||||||
| 843 | OECD Test No. 495: Ros (Reactive Oxygen Species) Assay for Photoreactivity | Yes | N/A | test method | OECD | https://www.oecd-ilibrary.org/docserver/915e00ac-en.pdf?expires=1695640495&id=id&accname=oid031827&checksum=3D64F57A6752B78E332468E958B99EC4 | Active Substance Part A (chemicals)5.2.7: Phototoxicity |
5.2.7: Phototoxicity (283-A) | ||||||
| 844 | OECD Series on Testing and Assessment No. 151: Guidance document supporting OECD test guideline 443 on the extended one-generation reproductive toxicity test | Yes | N/A | test method | OECD | https://one.oecd.org/document/ENV/JM/MONO(2013)10/en/pdf | Active Substance Part A (chemicals)5.6: Reproductive toxicity |
5.6: Reproductive toxicity (283-A) | ||||||
| 845 | Method A.6 Water solubility, Part A of Commission Regulation (EC) No 440/2008 | Yes | N/A | test method | - | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304 | Active Substance Part A (chemicals)2.5: Solubility in water |
2.5: Solubility in water (283-A) |
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