Active Substances
Active Substance Part B (micro-organisms)
- EFSA Guidance on submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA Journal 2011;9(2):2092) Website guidance document
- EFSA Scientific Opinion on the guidance on the use of the weight of evidence approach in scientific assessments (EFSA Journal 2017;15(8):4971) Website Noted by SCoPAFF guidance document
- OECD Guidance Document on Good In Vitro Method Practices (GIVIMP) Website guidance document
- EU Guidance document on the assessment of new isolates of baculovirus species already included in Annex I of Council Directive 91/414/EEC (SANCO/0253/2008) Website guidance document
- EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) Website guidance document
- OECD Guidance Document for the Regulatory Framework for the Microorganism Group: Bacteriophages Series on Pesticides No. 108 Website guidance document
- EU Guidance document for the assessment of the equivalence of technical grade active ingredients for identical microbial strains or isolates approved under Regulation (EC) No. 1107/2009 (SANCO/12823/2012) Website guidance document
1.4.2.2: Identity and content of relevant contaminating micro-organisms
2.7: Genetic stability and factors affecting it
- EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) Website guidance document
2.8: Information on metabolites of concern
- EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) Website guidance document
- EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) Website guidance document
2.9: Presence of transferable antimicrobial resistance genes
3.1: Function and target organism
- EPPO Standard PP1/248: Harmonized system for classification and coding of the uses of plant protection products Website guidance document test method
3.3: Crops or products protected or treated
- EPPO Global Database on Crops and Pests (EPPO, 2017) Website guidance document test method
- EPPO Standard PP1/248: Harmonized system for classification and coding of the uses of plant protection products Website guidance document test method
3.4: Information on possible development of resistance in the target organism(s)
- EPPO standard PP1/213: Resistance risk analysis Website guidance document test method
3.5: Literature data
4.1: Methods for the analysis of the MPCA as manufactured
- Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/2013. (SANCO/3030/99) Website guidance document
- OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 Website guidance document
4.2: Methods to determine the density of the micro-organism and quantify residues
5.1.3: Information on sensitisation and allergenicity
5.3.1.1: Oral infectivity and pathogenicity
5.3.1.2: Intratracheal/ intranasal infectivity and pathogenicity
5.3.1.3: Intravenous, intraperitoneal or subcutaneous single exposure
- US EPA OPPTS 885.3200 Microbial pesticide test methods. Acute injection toxicity/pathogenicity Website test method
5.3.2: Cell culture study
- US EPA OPPTS 885.3500 Cell culture Website test method
5.4: Specific infectivity and pathogenicity studies on the micro-organism
- US EPA OPPTS 885.3600 Subchronic Toxicity/Pathogenicity Website test method
- US EPA OPPTS 885.3650 Reproductive/fertility effects Website test method
5.5: Information and toxicity studies on metabolites
- European Commission draft guidance document Guidance for the setting of an acute reference dose (ARfD) (7199/VI/99) Website guidance document
- OECD Guidance for the Derivation of an Acute Reference Dose. Series on testing and assessment, No. 124 Website guidance document
- EFSA Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Journal 2019;17(6):5708) Website guidance document
6.1: Estimation of consumer exposure to residues
7.1.1: Predicted environmental density of the micro-organism
- EFSA Guidance document on clustering and ranking of emissions of active substances of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments, Section 2 (EFSA Journal 2014;12(3):3615) Website Noted by SCoPAFF guidance document
7.1.1.1: Soil
- EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents, section 3.1.2 (SANCO/12117/2012) Website guidance document
7.1.1.2: Water
- EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents, section 3.1.2 (SANCO/12117/2012) Website guidance document
7.2.1: Predicted environmental concentration
- Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (based on -among others- Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)) Website Noted by SCoPAFF guidance document
- Generic guidance for Tier 1 FOCUS Ground water assessments (based on -–among others-- the European Commission (2014) Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU - Final Report of the Ground Water Work Group of FOCUS (Sanco/13144/2010); FOCUS (2000) “FOCUS groundwater scenarios in the EU review of active substances” Report of the FOCUS Groundwater Scenarios Workgroup (Sanco/321/2000); Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil.(doi: 10.2903/j.efsa.2008.622); Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (including Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)); section 3.3.1 of European Food Safety Authority. Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil (doi:10.2903/j.efsa.2017.4982); section 3.3 of Scientific report of EFSA on the ‘repair action’ of the FOCUS surface water scenarios (doi:10.2903/j.efsa.2020.6119)) Website guidance document
- EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents, section 3.1.2 (SANCO/12117/2012) Website guidance document
- Environment and Climate Change Canada (2016), guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS1/RM/44) Website guidance document
- The relevant methods indicated under this Section may need to be adapted on a case-by-case basis. Hence the applicability of the methods selected, or adaptations of them, shall be justified in light of the biological and ecological characteristcs of the active substance to be assessed and it may be discussed in pre-submission meetings. Website
- US EPA 885.4000 (1996) Background for non-target organism testing of microbial pest control agents Website guidance document
8.1: Effects on terrestrial vertebrates
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS1/RM/44), 14.1 Birds Website guidance document test method
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 14.2 Small Mammals Website guidance document test method
8.2: Effects on aquatic organisms
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 11.1 Freshwater Fish Website guidance document test method
8.2.1: Effects on fish
- OECD Test Guideline 203: Fish, Acute Toxicity Test Website test method
- OECD Test Guideline 210: Fish, Early-life Stage Toxicity Test Website test method
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 11.1 Freshwater Fish Website guidance document test method
- US EPA OCSPP 885.4200 freshwater fish Tier I Website test method
8.2.2: Effects on aquatic invertebrates
- OECD Test No. 233 (2010) Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment Website test method
- US EPA OCSPP 885.4240 Freshwater invertebrate Tier I Website test method
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 10.1 Freshwater Invertebrates Website guidance document test method
8.2.3: Effects on algae
- OECD Test No. 201 Freshwater Alga and Cyanobacteria, Growth Inhibition Test Website test method
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 9.1 Freshwater plants Website guidance document test method
- US EPA OCSPP 885.4300 Non target plant studies Tier I Website test method
8.2.4: Effects on aquatic macrophytes
- OECD Test No. 221 Lemna sp. Growth Inhibition Test Website test method
- OECD Test No. 238: Sediment-Free Myriophyllum Spicatum Toxicity Test Website test method
- OECD Test No. 239: Water-Sediment Myriophyllum Spicatum Toxicity Test Website test method
8.3: Effects on bees
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.1 Honey bees Website guidance document test method
- OECD Guidance Document on the Honey Bee (Apis mellifera L.) Brood test Under Semi-field Conditions. Series on Testing and Assessment, No. 75 Website test method
- OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test Website test method
- OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test Website test method
- OECD Test Guideline 245 Honey Bee (Apis mellifera l.), Chronic Oral Toxicity Test Website test method
- OECD Guidance Document on Honey Bee Larval Toxicity Test following Repeated Exposure. Series on Testing and Assessment, No. 239 Website test method
- EPPO Bulletin (2010) 40 Side-Effects On Honeybees Website test method
- OECD Test No. 247 Bumblebee, Acute Oral Toxicity Test Website test method
- US EPA OCSPP 885.4380 Honey bee Tier I Website test method
- EPPO Bulletin (2019) 49 Oomen Bee Brood Feeding Test Website test method
8.4: Effects on non-target arthropods other than bees
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.1 Tests for Plant-Dwelling Invertebrates Website guidance document test method
- US EPA OCSPP 885.4340 Non-target Insect Tier I Website test method
8.5: Effects on non-target meso- and macro-organisms in soil
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.2 Springtails Website guidance document test method
- OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) Website test method
- OECD Test No. 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil Website test method
- OECD Test Guideline 232: Collembolan Reproduction Test in Soil Website test method
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.2 Earthworms Website guidance document test method
8.6: Effects on non-target terrestrial plants
- OECD Test No. 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Website guidance document test method
- OECD Test No. 227 : Terrestrial Plant Test: Vegetative Vigour Test Website guidance document test method
- Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 12.2 Terrestrial plants Website guidance document test method
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