Upućivanje na dio B Priloga Uredbi (EU) br. 284/2013

Metode istraživanja (7)

Smjernice (8)

Opće metode istraživanja i smjernice

EFSA Guidance on the use of the weight of evidence approach in scientific assessments (EFSA Journal 2017;15(8):4971)

Opće metode istraživanja i smjernice

ECHA Guidance on the Application of the CLP Criteria

Opće metode istraživanja i smjernice

OECD Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA) No. 260

Opće metode istraživanja i smjernice

OECD Guidance Document on Good In Vitro Method Practices (GIVIMP)

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)

OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65

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)

OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65.

OECD Guidance document on storage stability of microbial pest control products. Series on Pesticides No. 85 (ENV/JM/MONO(2016)54)

CIPAC MT 39 Stability of liquid formulations at 0°C

CIPAC MT 46 Accelerated storage procedure

CIPAC MT 53 Wettability

CIPAC MT 47 Persistent foaming

CIPAC MT 41 Dilution stability of herbicide aqueous solutions

CIPAC MT 160 Spontaneity of dispersion of suspension concentrates

CIPAC MT 174 Dispersibility of water dispersible granules

CIPAC MT 179 Dissolution degree and solution stability

CIPAC MT 180 Dispersion stability Suspo-emulsions

CIPAC MT 184 Suspensibility of formulations forming suspensions on dilution with water

CIPAC MT 196 Solution Properties of Water Soluble Tablets

CIPAC MT 170 Dry sieve analysis of water dispersible granules

CIPAC MT 187 Particle size analysis by laser diffraction

CIPAC MT 185 Wet sieve test

CIPAC MT 170 Dry sieve analysis of water dispersible granules

CIPAC MT 171 Dustiness of granular products

CIPAC MT 178 Attrition resistance of granules

CIPAC MT 185 Wet sieve test

CIPAC MT 187 Particle size analysis by laser diffraction

CIPAC MT 193 Attrition of tablets

CIPAC MT 197 Disintegration of Tablets

CIPAC MT 36 Emulsion characteristics of emulsifiable concentrates

CIPAC MT 148 Pourability of suspension concentrates

CIPAC MT 171 Dustiness of granular products

CIPAC MT 172 Flowability of water dispersible granules after heat test under pressure

ASTM E1518 – 05 Standard Practice for Evaluation of Physical Compatibility of Pesticides in Aqueous Tank Mixtures by the Dynamic Shaker Method

CIPAC MT 194 Adhesion to Treated Seed

CIPAC MT 175 Seed treatment formulations, liquid, determination of seed-seed uniformity of distribution

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

EPPO Global Database (9)

EPPO PP 1/248 Harmonized classification and coding of the uses of plant protection products (10)

EPPO PP1/239 Dose expression of plant protection products

EPPO PP1/292 Cleaning pesticide application equipment (PAE) – efficacy aspects

EU Guidance document: 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)

OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65

Residues Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830)

Posebne norme iz EPPO-ove serije normi PP1 (11)

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)

EU 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)

Opće norme iz EPPO-ove serije normi PP1 (12) (ocjenjivanje učinkovitosti sredstava za zaštitu bilja), konkretno: 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.

OECD Guidelines for Testing of Chemicals No. 208 „Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test” (2006)

EPPO PP1/207 Effects on succeeding crops

EPPO PP1/256 Effects on adjacent crops

OECD (2006) Guidelines for the Testing of Chemicals No. 227 „Terrestrial Plant Test: Vegetative Vigour Test”

OECD (2006) Guidelines for Testing of Chemicals No. 208 „Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test”

EFSA Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products (EFSA Journal 2022;20(1):7032)

OECD (2016) Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests Series on Testing & Assessment No. 237

OECD Test Guideline 423: Acute Oral toxicity - Acute Toxic Class Method

OECD Test Guideline 420: Acute Oral Toxicity - Fixed Dose Procedure

OECD Test Guideline 402: Acute Dermal Toxicity - Fixed Dose Procedure

OECD Test Guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method

OECD Test Guideline 403: Acute Inhalation Toxicity

OECD Test Guideline 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method

OECD Test Guideline 404: Acute Dermal Irritation/Corrosion

OECD Test Guideline 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER)

OECD Test Guideline 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method

OECD Test Guideline 435: In vitro Membrane Barrier Test Method for Skin Corrosion

OECD Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation, No. 203

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

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

OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants

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

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

OECD Test Guideline 405: Acute eye irritation/corrosion

OECD Test Guideline 442A: Skin Sensitisation – Local Lymph Node Assay: DA

OECD Test Guideline 442B: Skin Sensitisation - Local Lymph Node Assay: BrdU-ELISA or –FCM

OECD Test Guideline 442C: In Chemico Skin Sensitisation

OECD Test Guideline 442D: In Vitro Skin Sensitisation

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

OECD Guideline No. 497: Defined Approaches on Skin Sensitisation

OECD Test Guideline 406: Skin Sensitisation Guinea Pig Maximisation Test and Buehler Test

OECD Test Guideline 429: Skin Sensitisation – Local Lymph Node Assay

OECD Test Guideline 428: Skin Absorption: In Vitro Method

OECD Test Guideline 427: Skin Absorption: In Vivo Method

EU Guidance on dermal absorption (SANTE/2018/10591)

EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258)

EFSA Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products (SANTE-10832-2015)

EFSA Guidance on dermal absorption (EFSA Journal 2017;15(6):4873)

FAO Operator exposure models and local risk assessment (13)

EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258)

EFSA Guidance on the establishment of the residue definition for dietary risk assessment (EFSA Journal 2016;14(12):4549)

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)

Metode istraživanja navedene u Komunikaciji Komisije za provedbu dijela B Priloga Uredbi (EU) br. 283/2013 ili u Komunikaciji relevantnoj za provedbu dijela A Priloga Uredbi Komisije (EU) br. 284/2013 mogu se upotrijebiti kao osnova i ponovno prilagoditi. Primjenjivost odabranih metoda ili njihovih prilagodbi mora biti opravdana s obzirom na posebnosti predmetnog slučaja i o tome se može raspravljati na sastancima prije podnošenja zahtjeva.

EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258)

OECD Guidance to the environmental safety evaluation of microbial biocontrol agents, Series on Pesticides No. 67 (ENV/JM/MONO(2012)1)