Plant Protection Products
PPP Part B (micro-organisms)
- ECHA Guidance on the Application of the CLP Criteria Website guidance document
- EFSA Scientific Opinion on the guidance on the use of the weight of evidence approach in scientific assessments (EFSA Journal 2017;15(8):4971) Website Noted by SCoPAFF guidance document
- OECD Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA) No. 260 Website guidance document
- OECD Guidance Document on Good In Vitro Method Practices (GIVIMP) Website guidance document
- EU Guidance document for the assessment of the equivalence of technical grade active ingredients for identical microbial strains or isolates approved under Regulation (EC) No. 1107/2009 (SANCO/12823/2012) Website guidance document
1.4: Detailed quantitative and qualitative information on the composition of the preparation
- EU Guidance document on significant and non-significant changes of the chemical composition of authorised plant protection products under Regulation (EC) No 1107/2009 of the EU Parliament and Council on placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (SANCO/12638/2011) Website guidance document
- OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 Website guidance document
2.6: Storage stability and shelf life
- OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 Website guidance document
- OECD Guidance document on storage stability of microbial pest control products. Series on Pesticides No. 85 (ENV/JM/MONO(2016)54) Website guidance document
2.6.2: Effects of temperature and packaging
- CIPAC Method MT 46: Accelerated storage procedure Website test method
- CIPAC MT 39 Stability of liquid formulations at 0˚C Website test method
2.7: Technical characteristics of the plant protection product
2.7.1: Wettability
- CIPAC Method MT 53: Wettability Website test method
2.7.2: Persistent foaming
- CIPAC Method MT 47 Persistent foaming Website test method
2.7.3: Suspensibility, spontaneity of dispersion and dispersion stability
- CIPAC MT 41 Dilution stability of herbicide aqueous solutions Website test method
- CIPAC MT 179 Dissolution degree and solution stability Website test method
- CIPAC Method MT 196: Solution Properties of Water Soluble Tablets Website test method
- CIPAC Method MT 184: Suspensibility of formulations forming suspensions on dilution with water Website test method
- CIPAC Method MT 160: Spontaneity of dispersion of suspension concentrates Website test method
- CIPAC Method MT 174: Dispersibility of water dispersible granules Website test method
- CIPAC Method MT 180: Dispersion stability of suspo-emulsion Website test method
2.7.4: Dry sieve test and wet sieve test
- CIPAC Method MT 185: Wet sieve test Website test method
- CIPAC Method MT 187: Particle size analysis by laser diffraction Website test method
- CIPAC Method MT 170: Dry sieve analysis of water dispersible granules Website test method
2.7.5: Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)
- CIPAC Method MT 185: Wet sieve test Website test method
- CIPAC Method MT 187: Particle size analysis by laser diffraction Website test method
- CIPAC Method MT 170: Dry sieve analysis of water dispersible granules Website test method
- CIPAC Method MT 171: Dustiness of granular products Website test method
- CIPAC Method MT 178: Attrition resistance of granules Website test method
- CIPAC Method MT 193: Attrition of tablets Website test method
- CIPAC Method MT 197: Disintegration of tablets Website test method
2.7.6: Emulsifiability, re-emulsifiability and emulsion stability
2.7.7: Flowability, pourability (rinsability) and dustability
- CIPAC Method MT 171: Dustiness of granular products Website test method
- CIPAC Method MT 148: Pourability of suspension concentrates, Website test method
- CIPAC Method MT 172: Flowability of granular preparations after accelerated storage under pressure Website test method
2.8: Physical and chemical compatibility with other plant protection products including plant protection products with which its use is to be authorised
- ASTM E1518 – 05: Standard Practice for Evaluation of Physical Compatibility of Pesticides in Aqueous Tank Mixtures by the Dynamic Shaker Method Website test method
2.9: Adherence and distribution to seeds
- CIPAC MT 175: Seed treatment formulations, liquid, determination of seed-seed uniformity of distribution Website test method
- CIPAC Method MT 194: Adhesion to Treated Seed Website test method
- European Seed Association, 2011. Assessment of free floating dust and abrasion particles of treated seeds as a parameter of the quality of treated seeds: Heubach test. ESA STAT Dust Working Group. Website test method
- EPPO Global Database on Crops and Pests (EPPO, 2017) Website guidance document test method
3.3: Function, target organisms and plants or plants products to be protected and possible risk mitigation measures
- EPPO Standard PP1/248: Harmonized system for classification and coding of the uses of plant protection products Website guidance document test method
3.4: Application rate
- EPPO Standard PP1/239: Dose expression of plant protection products Website guidance document test method
4.1: Procedures for cleaning and decontaminating of application equipment
- EPPO Standard PP1/292: Cleaning pesticide application equipment (PAE) – efficacy aspects Website guidance document test method
5.1: Methods for the analysis of the preparation
- Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/2013. (SANCO/3030/99) Website guidance document
- OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 Website guidance document
5.2: Methods to determine and quantify residues
- Guidance document on the efficacy composition of core dossier and national addenda submitted to support the authorization of plant protection products under regulation (EC) No 1107/2009 of the EU Parliament and Council on placing of plant protection products on the market SANCO/10055/2013 Website guidance document
- EU guidance document on data requirements on efficacy for the dossier to be submitted for the approval of new active substances contained in plant protection products. (SANCO/10054/2013) Website guidance document
- General EPPO standard series PP1 (Efficacy evaluation of plant protection products), in particular: EPPO PP1/276 Principles of efficacy evaluation for microbial plant protection products, EPPO PP1/296 principles of efficacy evaluation for low-risk plant protection products, and, EPPO PP1/319 General principles for efficacy evaluation of plant protection products with a mode of action as plant defence inducers. Website guidance document
- Specific Standards of the EPPO standard series PP1 Website test method
6.6.1: Impact on succeeding crops
- EPPO PP1/207 Effects on succeeding crops Website guidance document
- OECD Test No. 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Website guidance document test method
6.6.2: Impact on other plants, including adjacent crops
- EPPO PP1/256 Effects on adjacent crops Website guidance document
- OECD Test No. 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Website guidance document test method
- OECD Test No. 227 : Terrestrial Plant Test: Vegetative Vigour Test Website guidance document test method
7.2: Assessment of potential toxicity of the plant protection product
- EFSA Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products (SANTE-10832-2015, EFSA Journal 2022;20(1):7032) Website Noted by SCoPAFF guidance document
7.3: Acute toxicity
- OECD Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests. Series on Testing & Assessment, No. 237 Website guidance document
7.3.1: Acute oral toxicity
- OECD Test Guideline 420: Acute oral toxicity: fixed dose procedure Website test method
- OECD Test Guideline 423: Acute oral toxicity: acute toxic class method Website test method
7.3.2: Acute dermal toxicity
7.3.3: Acute inhalation toxicity
- OECD Test Guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method Website test method
- OECD Test Guideline 403: Acute Inhalation Toxicity Website test method
7.3.4: Skin irritation
- OECD Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation. Series on Testing and Assessment, No. 203 Website guidance document
- OECD Test Guideline 431: In vitro Skin Corrosion: reconstructed human epidermis (RHE) test method Website test method
- OECD Test Guideline 435: In vitro Membrane Barrier Test Method for Skin Corrosion Website test method
- OECD Test Guideline 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method Website test method
- OECD Test Guideline 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) Website test method
- OECD Test Guideline 404: Acute Dermal Irritation/Corrosion Website test method
7.3.5: Eye irritation
- OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants Website test method
- OECD Test Guideline 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage Website test method
- OECD Test Guideline 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage Website test method
- OECD Test Guideline 405: Acute eye irritation/corrosion Website test method
- OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage Website test method
- OECD Test Guideline 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage Website test method
7.3.6: Skin sensitisation
- OECD Test Guideline 442B: Skin Sensitisation – Local Lymph Node Assay: BrdU-ELISA Website test method
- OECD Test Guideline 429: Skin Sensitisation – Local Lymph Node Assay Website test method
- OECD Test Guideline 406: Skin sensitisation Website test method
- OECD Test Guideline 442A: Skin Sensitisation – Local Lymph Node Assay: DA Website test method
- OECD Guideline No. 497: Defined Approaches on Skin Sensitisation Website test method
- OECD Test Guideline 442D: In Vitro Skin Sensitisation Website test method
- OECD Test Guideline 442E: In Vitro Skin Sensitisation: In Vitro Skin Sensitisation Assays Addressing the Key Event on Activation of Dendritic Cells on the Adverse Outcome Pathway for Skin Sensitisation Website test method
- OECD Test Guideline 442C: In Chemico Skin Sensitisation Website test method
7.5: Data on exposure
- EU Guidance on dermal adsorption (SANTE/2018/10591) Website Noted by SCoPAFF guidance document
- EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) Website guidance document
- EFSA Guidance on dermal absorption (EFSA Journal 2017;15(6):4873) Website Noted by SCoPAFF guidance document
- FAO Operator exposure models and local risk assessment Website guidance document
- OECD Test Guideline 428: Skin absorption: in vitro method Website test method
- OECD Test Guideline 427: Skin absorption: in vivo method Website test method
- EFSA Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products (SANTE-10832-2015, EFSA Journal 2022;20(1):7032) Website Noted by SCoPAFF guidance document
- EFSA Guidance on the establishment of the residue definition for dietary risk assessment (EFSA Journal 2016;14(12):4549) Website guidance document
- EFSA Reporting data on pesticide residues in food and feed according to Regulation (EC) No 396/2005 (2018 data collection) (EFSA Journal 2019;17(4):5655) Website guidance document
- EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) Website guidance document
- EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) Website guidance document
- Test methods indicated either in the Commission's Communication for the implementation of Part B of the Annex to Commission Regulation (EU) No 283/2013, or in the Commission's Communication for the implementation of Part A of the Annex to Commission Regulation (EU) No 284/2013 may be used as a basis and re-adapted. The applicability of the methods selected, or adaptations of them, shall be justified in light of the specificities of the case at stake and it may be discussed in pre-submission meetings.
- OECD Guidance to the environmental safety evaluation of microbial biocontrol agents, Series on Pesticides No. 67 (ENV/JM/MONO(2012)1) Website guidance document
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