Odniesienie do części A załącznika do rozporządzenia (UE) nr 284/2013

Wytyczne

Uwagi

Wytyczne ogólne

EFSA Guidance on Uncertainty Analysis in Scientific Assessments. (EFSA Journal 2018;16(1):5123)

Wytyczne ogólne

EFSA Guidance on the assessment of the biological relevance of data in scientific assessments (EFSA Journal 2017;15(8):4970)

Wytyczne ogólne

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

Wytyczne ogólne

OECD Guidance Document for Describing Non-Guideline In-vitro Test Methods, . Series on Testing and Assessment, No 211

Wytyczne ogólne

Guidance document for environmental risk assessments of active substances used on rice in the EU for Annex 1 inclusion (SANCO/1090/2000)

Wytyczne ogólne

Guidance document on botanical active substances used in plant protection products (SANCO/11470/2012)

Wytyczne ogólne

Guidance document on semiochemical active substances used and plant protection products (SANTE/12815/2014)

Wytyczne ogólne

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)

Wytyczne ogólne

OECD Guidance document on the recognition, assessment, and use of clinical signs as human endpoints for experimental animals used in safety evaluation. Series on Testing and Assessment, No 19

Wytyczne ogólne

OECD Consideration for assessing the risk of combined exposure to multiple chemicals. Series on Testing and Assessment, No 296

Wytyczne ogólne

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)

Wytyczne ogólne

ECHA Guidance on the Application of the CLP Criteria

Wytyczne ogólne

OECD Guidance Documents on the Validation of (Quantitative) Structure-Activity Relationship [(Q)SAR] Models. Series on Testing and Assessment No 69.

Wytyczne ogólne

ECHA Practical Guide – how to use and report (Q)SARs

Wytyczne ogólne

OECD Guidance on Grouping of Chemicals, Second Edition. Series on Testing and Assessment, No 194

Wytyczne ogólne

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

Wytyczne ogólne

OECD Guidance Document on Developing and Assessing Adverse Outcome Pathways. Series on Testing and Assessment No 184

Wytyczne ogólne

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

Wytyczne ogólne

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

Wytyczne ogólne

EFSA Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Journal 2019;17(6):5708)

Wytyczne ogólne

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)

Wytyczne ogólne

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)

Wytyczne ogólne

ECHA. Read-Across Assessment Framework (RAAF), ECHA-17-R-01-EN

WHO/FAO Pesticide Specifications. Manual on development and use of FAO and WHO specifications for chemical pesticides

EU Guidance Document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No 1107/2009 (SANCO/10597/2003)

WHO/FAO Pesticide Specifications. Manual on development and use of FAO and WHO specifications for chemical pesticides

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)

ECHA Guidance on the Application of the CLP Criteria

-

-

OECD Guidance Document for flammability testing of plant protection and biocidal products Series on Testing and Assessment, No 330

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

—

FAO Guidelines for the packaging and storage of pesticides (FAO, Rome, 1985)

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)

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.

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)

Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE/2017/10632)

Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830)

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.

Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE/2017/10632)

Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830)

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.

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)

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)

EPPO standard series PP1: Efficacy evaluation of plant protection products

Należy uwzględnić wyłącznie zastosowania uznane za istotne na podstawie rozporządzenia (WE) nr 1107/2009, a nie zastosowania określone w EPPO PP1/248, które dotyczą określenia „biostymulator” zarówno zgodnie z rozporządzeniem (UE) 2019/1009, jak i ze specyfikacjami technicznymi CEN/TS 17724, CEN/TS 17700-1, CEN/TS 17700-2, CEN/TS 17700-3, CEN/TS 17700-4, CEN/TS 17700-5, nawet jeśli te biostymulatory zostały zidentyfikowane jako regulatory wzrostu w EPPO PP1/248.

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

OECD Guidance document on acute oral toxicity testing. OECD Series on Testing and Assessment, No 24

OECD Guidance Document on using Cytotoxicity Tests to Estimate Starting Doses for Acute Oral Systemic Toxicity Tests. Series on Testing and Assessment, No 129

-

OECD Guidance Document for the Derivation of an Acute Reference Concentration (Arfc). Series on Testing and Assessment, No 153

OECD Guidance Document on inhalation toxicity studies. Series on Testing and Assessment No 39:

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

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

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 & Assessment, No 160.

-

-

-

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)

OECD Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application. Series on Testing and Assessment No 9

-

-

-

-

-

OECD Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application. Series on Testing and Assessment No 9

-

-

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

-

Zastosowanie mają wytyczne zgłoszone w sekcji 6 załącznika I do komunikatu C(2023) 6245.

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)

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))

Wymieniono ogólne wytyczne FOCUS, które opierają się na odpowiednich, bardziej szczegółowych wytycznych i są regularnie aktualizowane.

-

DG SANCO Working Document on „Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides”

OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides No 82. Series on Testing and Assessment, No 232.

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)

Zastosowanie mają wytyczne zgłoszone w sekcji 7.1.2 i 7.1.3.1 załącznika I do komunikatu C(2023) 6245.

Zgodnie z sekcją 9.1.2.1 części A załącznika do

rozporządzenia (UE) nr 284/2013, zastosowanie mają przepisy zawarte w części A pkt 7.1.2 i 7.1.3.1 załącznika do rozporządzenia (UE) nr 283/2013.

-

-

Soil persistence models and EU registration, final report of the FOCUS Soil modelling workgroup, SANCO/7617/VI/96

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)

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))

Wymieniono ogólne wytyczne FOCUS, które opierają się na odpowiednich, bardziej szczegółowych wytycznych i są regularnie aktualizowane.

DG SANCO Working Document on „Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides”

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))

Wymieniono ogólne wytyczne FOCUS, które opierają się na odpowiednich, bardziej szczegółowych wytycznych i są regularnie aktualizowane.

DG SANCO Working Document on „Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides”

-

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 EFSA. 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))

Wymieniono ogólne wytyczne FOCUS, które opierają się na odpowiednich, bardziej szczegółowych wytycznych i są regularnie aktualizowane.

Higher tiers: 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)

Higher tiers: Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments EC Document Reference (SANTE/12586/2020)

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)

-

-

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))

Wymieniono ogólne wytyczne FOCUS, które opierają się na odpowiednich, bardziej szczegółowych wytycznych i są regularnie aktualizowane.

Pesticides in Air: Considerations for Exposure Assessment". Report of the FOCUS Working Group on Pesticides in Air (SANCO/10553/2006)

Pesticides in Air: Considerations for Exposure Assessment". Report of the FOCUS Working Group on Pesticides in Air (SANCO/10553/2006)

-

OECD Current approaches in the statistical analysis of ecotoxicity data: a guidance to application. . Series of testing and assessment, No 54

EFSA Risk assessment for birds and mammals (EFSA Journal 2009; 7(12):1438)

-

-

-

-

-

-

-

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)

OECD Guidance document on aqueous-phase aquatic toxicity testing of difficult test chemicals. Series on Testing and Assessment, No 23 (Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures)

Zastosowanie mają wytyczne zgłoszone w pkt 8.2 załącznika I do komunikatu C(2023) 6245.

Zgodnie z sekcją 10.2.1 części A załącznika do rozporządzenia (UE) nr. 284/2013 badania należy przeprowadzić na jednym gatunku z każdej z trzech/czterech grup organizmów wodnych, czyli na rybach, bezkręgowcach wodnych, algach i – w stosownych przypadkach – makrofitach, o czym mowa w części A pkt 8.2 załącznika do rozporządzenia (UE) nr 283/2013, jeżeli środek ochrony roślin jako taki może skazić wodę.

Zastosowanie mają wytyczne zgłoszone w pkt 8.2.2 i 8.2.5 załącznika I do komunikatu C(2023) 6245.

Zgodnie z sekcją 10.2.2 części A załącznika do rozporządzenia (UE) nr. 284/2013, badania, o których mowa w pkt 8.2.2 i 8.2.5 części A załącznika do rozporządzenia (UE) nr 283/2013 należy przeprowadzić dla poszczególnych środków ochrony roślin, jeśli nie można przeprowadzić ekstrapolacji z danych uzyskanych z odpowiednich badań substancji czynnej (np. toksyczność ostra środka ochrony roślin w postaci produkowanej jest 10 razy wyższa w stosunku do substancji czynnej), chyba że wykazano, że narażenie nie nastąpi.

-

EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002)

-

-

-

-

-

-

-

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

De Jong et al. (2010) Guidance for summarising and evaluating field studies with non-target arthropods

-

-

-

-

-

EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002)

-

De Jong et al. (2006): Guidance for summarizing earthworm field studies. RIVM report No 601506006/2006

-

-

-

EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002)

EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002)

-

-

-

-

EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002)

-

EFSA 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):209)

EFSA Application of systematic review methodology to food and feed safety assessments to support decision making (EFSA Journal 2010;8(6):1637)

ECHA Guidance on the Application of the CLP Criteria

Odniesienie do części A załącznika do rozporządzenia (UE) nr 284/2013

Metody badania

Uwagi

Wytyczne dotyczące niektórych klas substancji

-

-

Test methods according to Test series 1-3, Part I of the UN RTDG Manual of Tests and Criteria

Method A.14 Explosive properties (Annex of Regulation (EC) No 440/2008).

Test method according to Section 2.4.4. of Part 2 of Annex I to Regulation (EC) No 1272/2008

Test O.2: Test for oxidizing liquids, Part III of UN RTDG Manual of Tests and Criteria

Test O.1: Test for oxidizing solids, Part III of UN RTDG Manual of Tests and Criteria

Test O.3: Gravimetric test for oxidising solids, Part III of UN RTDG Manual of Tests and Criteria

Method A.17 Oxidising properties (solids) (Annex of Regulation (EC) No 440/2008)

Dla stałych preparatów

Method A.21 Oxidising properties (liquids) (Annex of Regulation (EC) No 440/2008)

Method A.9 Flash-point (liquids) (Annex of Regulation (EC) No 440/2008)

Test methods according to table 2.6.3 of Annex I, Part 2 of Regulation (EC) No 1272/2008 (liquids)

Test N.1: Test method for flammable solids, Part III of UN RTDG Manual of Tests and Criteria (solids)

Method A.10 Flammability (Annex of Regulation (EC) No 440/2008) for solids (solids)

Method A.11 Flammability (Annex of of Regulation (EC) No 440/2008) for gaseous materials (gaseous materials)

Method A.12 (Annex of of Regulation (EC) No 440/2008) for contact with water (solids and liquids)

Test methods according to Section 2.2.4.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008

Test L.2: sustained combustibility test, Part III of the UN RTDG Manual of Tests and Criteria

Method A.15 (Annex of of Regulation (EC) No 440/2008) for liquids and Gases (liquids and gases)

Method A.16 (Annex of of Regulation (EC) No 440/2008) for solids (solids)

Test N.4: test method for self-heating substances, Part III of UN RTDG Manual of Tests and Criteria

ISO/IEC 80079-20-1:2017 – Explosive atmospheres - Part 20-1: Material characteristics for gas and vapour classification - Test methods and data

CIPAC Method MT 75: Determination of pH values

CIPAC Method MT 31: free acidity or alkalinity

CIPAC Method MT 191: Acidity or alkalinity of formulations

Test methods according to Part III of the UN RTDG Manual of Tests and Criteria

OECD Test Guideline 122: Determination of pH, Acidity and Alkalinity

OECD Test Guideline 114: Viscosity of Liquids

Ma zastosowanie do cieczy newtonowskich i nienewtonowskich

CIPAC method MT 192: Viscosity of liquids by rotational viscosimetry

Ma zastosowanie do cieczy newtonowskich i nienewtonowskich

OECD Test Guideline 115: Surface Tension of Aqueous Solutions

Method A.5 Surface tension, (Annex of Commission Regulation (EC) No 440/2008)

Method A.3 Relative density (Annex of Regulation (EC) No 440/2008).

OECD Test Guideline 109 - Density of Liquids and Solids

CIPAC Method MT 186: Bulk density

CIPAC Method MT 46: Accelerated storage procedure

CIPAC Method MT 39: Low temperature stability of liquid formulations

-

CIPAC Method MT 53: Wettability, wetting of wettable powders

CIPAC Method MT 47 Persistent foam

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

CIPAC Method MT 160: Spontaneity of dispersion of suspension concentrates

CIPAC Method MT 174: Dispersibility of water dispersible granules

CIPAC Method MT 180: Dispersion stability of suspo-emulsion

CIPAC Method MT 41: Dilution stability of aqueous solutions

CIPAC Method MT 179: Degree of Dissolution and Solution Stability

CIPAC Method MT 196: Solution Properties of Water Soluble Tablets (ST)

-

CIPAC Method MT 185: Wet sieve test

Dotyczy środków dyspergowanych w wodzie.

CIPAC Method MT 187: Particle size analysis by laser diffraction

Dotyczy proszków i granul

CIPAC Method MT 170: Dry sieve analysis of water dispersible granules

Dotyczy granul

CIPAC Method MT 171: Dustiness of granular products

CIPAC Method MT 178: Attrition resistance of granules

CIPAC Method MT 193: Attrition of tablets

CIPAC Method MT 197: Disintegration of tablets

CIPAC Method MT 36: Emulsion characteristics and re-emulsification properties

CIPAC Method MT 172: Flowability of granular preparations after accelerated storage under pressure

CIPAC Method MT 148: Pourability of suspension concentrates

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

CIPAC Method MT 175: Determination of seed-to-seed uniformity of distribution for liquid seed-treatment formulations

CIPAC Method MT 194: Adhesion to Treated Seed

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.

Test methods reported in Annex I, Part II to Regulation (EC) No 1272/2008

CIPAC Method MT 176 Dissolution rate of water soluble bags

CIPAC Method MT 23 Miscibility with hydrocarbon oil

EPPO Standard PP1/239: Dose expression of plant protection products

EPPO Standard PP1/240: Harmonized basic information for databases on plant protection products

EPPO Standard PP1/248: Harmonized system for classification and coding of the uses of plant protection products

Należy uwzględnić wyłącznie zastosowania uznane za istotne na podstawie rozporządzenia (WE) nr 1107/2009, a nie zastosowania określone w EPPO PP1/248, które dotyczą określenia „biostymulator” zarówno zgodnie z rozporządzeniem (UE) 2019/1009, jak i ze specyfikacjami technicznymi CEN/TS 17724, CEN/TS 17700-1, CEN/TS 17700-2, CEN/TS 17700-3, CEN/TS 17700-4, CEN/TS 17700-5, nawet jeśli te biostymulatory zostały zidentyfikowane jako regulatory wzrostu w EPPO PP1/248.

EPPO Standard PP1/291: Evaluation of the influence of tank mix adjuvants on the efficacy of plant protection products

EPPO Standard PP1/306: General principles for the development of co-formulated mixtures of plant protection products

EPPO Global Database on Crops and Pests (EPPO, 2017)

Baza danych dostępna w internecie: https://gd.eppo.int

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

—

EPPO standard series PP1 (Efficacy evaluation of plant protection products)

-

-

-

-

-

-

-

-

ISTA Methods

W przypadku nasion zebranych z roślin poddanych działaniu środka

-

-

-

-

-

-

OECD Test Guideline 420: Acute oral toxicity: fixed dose procedure

OECD Test Guideline 423: Acute oral toxicity: acute toxic class method

OECD Test Guideline 425: Acute oral toxicity: up-and-down procedure

OECD Test Guideline 401: Acute oral toxicity (only acceptable, if performed before December 2002)

OECD Test Guideline 402: Acute Dermal Toxicity

OECD Test Guideline 433: Acute Inhalation Toxicity: Fixed Concentration Procedure

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

OECD Test Guideline 403: Acute Inhalation Toxicity

Istniejące badania są dopuszczalne, ale jeżeli ma zostać przeprowadzone nowe badanie, pierwszeństwo należy przyznać wytycznym OECD dotyczącym badań nr 433, ponieważ wymagana jest mniejsza liczba zwierząt laboratoryjnych lub metoda ta wiąże się z mniej dotkliwym cierpieniem zwierząt laboratoryjnych.

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

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

OECD Test Guideline 404: Acute Dermal Irritation/Corrosion

OECD Test Guideline 492B. Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification

OECD Test Guideline 467. Defined Approaches for Serious Eye Damage and Eye Irritation

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

OECD Test No 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage

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 442B: Skin Sensitisation – Local Lymph Node Assay: BrdU-ELISA

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

OECD Test Guideline 406: Skin sensitisation

Ponieważ test Buehlera jest uważany za mniej czuły niż test maksymalizacji, preferowany jest wybór testu maksymalizacji.

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

-

-

-

-

-

-

-

-

-

-

-

-

OECD Test Guideline 428: Skin absorption: in vitro method

OECD Test Guideline 427: Skin absorption: in vivo method

-

W stosownych przypadkach zastosowanie mają te same metody badań, o których mowa w sekcji 6 załącznika II do komunikatu Komisji C(2023) 6245.

Zgodnie z sekcją 8 części A załącznika do rozporządzenia Komisji (UE) nr 284/2013 należy przedłożyć dane i informacje dotyczące pozostałości w lub na produktach, żywności i paszy poddanych działaniu środka, zgodne z częścią A sekcja 6 załącznika do rozporządzenia (UE) nr 283/2013, chyba że wnioskodawca wykaże, że można zastosować dane lub informacje uprzednio przedłożone, dotyczące danej substancji czynnej.

-

OECD Test Guideline 307: Aerobic and anaerobic transformation in soil.

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

Badanie przeprowadzone do dnia publikacji niniejszego komunikatu jest nadal ważne, jednak nowe badanie należy przeprowadzić zgodnie z normą ISO 18400

ISO 18400-102:2017

ISO 18400-104:2018

ISO 18400-105:2017

ISO 18400-206:2018

-

OECD Test Guideline 307: Aerobic and anaerobic transformation in soil.

OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides, No 82. Series on Testing and Assessmen,t No 232.

-

OECD Test Guideline 106: Adsorption - Desorption Using a Batch Equilibrium Method

OECD Test Guideline 121: Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC)

OECD Test Guideline 312: Leaching in Soil Columns

OECD Test Guideline 307: Aerobic and anaerobic transformation in soil.

OECD Guidance Document for the Performance Of Out-door Monolith Lysimeter Studies. Series on Testing and Assessment, No 22

OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides, No 82. Series on Testing and Assessment, No 232.

-

-

OECD Test Guideline 309: Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test

OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems

OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems

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)

-

OECD ENV/JM/MONO(2016)6 Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies Series on Pesticides No 82 / Series on Testing and Assessment No 232.

-

-

-

-

-

-

-

OECD Test Guideline 223: Avian Acute oral toxicity study

US EPA OCSPP 850.2100: Avian Acute Oral Toxicity Test

-

-

Zob. 7.1.1.

-

OECD Test Guideline 248: Xenopus Eleutheroembryonic Thyroid Assay (XETA)

OECD Test Guideline 231: Amphibian Metamorphosis Assay

OECD Test Guideline 241: Larval Amphibian Growth and Development Test

-

W stosownych przypadkach zastosowanie mają te same metody badań, o których mowa w sekcji 8.2 załącznika II do komunikatu Komisji C(2023) 6245.

Zgodnie z sekcją 10.2.1 części A załącznika do rozporządzenia Komisji (UE) nr. 284/2013 badania należy przeprowadzić na jednym gatunku z każdej z trzech/czterech grup organizmów wodnych, czyli na rybach, bezkręgowcach wodnych, algach i – w stosownych przypadkach – makrofitach, o czym mowa w części A pkt 8.2 załącznika do rozporządzenia (UE) nr 283/2013, jeżeli środek ochrony roślin jako taki może skazić wodę.

W stosownych przypadkach zastosowanie mają te same metody badań, o których mowa w pkt 8.2.2 i 8.2.5 załącznika II do komunikatu Komisji C(2023) 6245.

Zgodnie z sekcją 10.2.2 części A załącznika do rozporządzenia Komisji (UE) nr. 284/2013, badania, o których mowa w pkt 8.2.2 i 8.2.5 części A załącznika do rozporządzenia (UE) nr 283/2013. należy przeprowadzić dla poszczególnych środków ochrony roślin, jeśli nie można przeprowadzić ekstrapolacji z danych uzyskanych z odpowiednich badań substancji czynnej (np. toksyczność ostra środka ochrony roślin w postaci produkowanej jest 10 razy wyższa w stosunku do substancji czynnej), chyba że wykazano, że narażenie nie nastąpi.

-

-

-

-

EPPO 170(4) Side-effects on honeybees

OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test

OECD Test Guideline 247: Bumblebee, Acute Oral Toxicity Test

EPPO 170(4) Side-effects on honeybees

OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test

OECD Test Guideline 246: Bumblebee, Acute Contact Toxicity Test

OECD Test Guideline 245: Honey bee (Apis mellifera l.), chronic oral toxicity test (10-day feeding)

OECD Guidance Document on the honeybee (Apis mellifera L.) brood test under semi-field conditions (only for spray applications). Series on Testing and Assessment, No 75

OECD Guidance Document on Honey Bee Larval Toxicity Test following Repeated Exposure, Series on Testing and Assessment No 239

OECD Test Guideline No 237 Honey Bee (Apis mellifera) Larval Toxicity Test, Single Exposure

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.

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.

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

EPPO 170(4) Side-effects on honeybees

OECD Guidance Document on the Honey Bee (Apis mellifera L.) Brood test Under Semi-field Conditions . Series on Testing and Assessment, No 75

EPPO 170(4) Side-effects on honeybees

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.

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.

-

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)

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)

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)

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)

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)

-

-

-

OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

ISO 11268-3:2014: Soil quality - Effects of pollutants on earthworms -- Part 3: Guidance on the determination of effects in field situations

ISO 23611-1:2018: Soil quality - Sampling of soil invertebrates - Part 1: Hand-sorting and extraction of earthworms

ISO 23611-2:2006 Soil Quality - Sampling of soil invertebrates - Part 2: Sampling and extraction of micro-arthropods (Collembola and Acarina)

OECD Test Guideline 232: Collembolan Reproduction Test in Soil

OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

-

OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test

-

-

OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test

OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test

-

-

-

-

-

Odniesienie do części A załącznika do rozporządzenia (UE) nr 283/2013

Wytyczne

Uwagi

Wytyczne ogólne

EFSA Guidance on the use of the benchmark dose approach in risk assessment (EFSA Journal 2017;15(1):4658)

Wytyczne ogólne

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)

Wytyczne ogólne

EFSA Guidance on Uncertainty Analysis in Scientific Assessments (EFSA Journal 2018;16(1):5123)

Wytyczne ogólne

EFSA Guidance on the assessment of the biological relevance of data in scientific assessments (EFSA Journal 2017;15(8):4970)

Wytyczne ogólne

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

Wytyczne ogólne

OECD Consideration for assessing the risk of combined exposure to multiple chemicals. Series on Testing and Assessment No 296

Wytyczne ogólne

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)

Wytyczne ogólne

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

Wytyczne ogólne

OECD Guidance Document on Developing and Assessing Adverse Outcome Pathways. Series on Testing and Assessment No 184

Wytyczne ogólne

OECD Guidance Document for Describing Non-Guideline In-vitro Test Methods. Series on Testing and Assessment, No 211

Wytyczne ogólne

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

Wytyczne ogólne

ECHA Guidance on the Application of the CLP Criteria

Wytyczne ogólne

Guidance document for environmental risk assessments of active substances used on rice in the EU for Annex 1 inclusion (SANCO/1090/2000)

Wytyczne ogólne

Guidance document on botanical active substances used in plant protection products (SANCO/11470/2012)

Wytyczne ogólne

Guidance document on semiochemical active substances used and plant protection products (SANTE/12815/2014)

Wytyczne ogólne

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)

Wytyczne ogólne

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)

Wytyczne ogólne

OECD Guidance Documents on the Validation of (Quantitative) Structure-Activity Relationship [(Q)SAR] Models. Series on Testing and Assessment No 69.

Wytyczne ogólne

ECHA Practical Guide – how to use and report (Q)SARs

Wytyczne ogólne

OECD Guidance on Grouping of Chemicals, Second Edition. Series on Testing and Assessment, No 194

Wytyczne ogólne

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

Wytyczne ogólne

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

Wytyczne ogólne

EFSA Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Journal 2019;17(6):5708)

Wytyczne ogólne

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)

Wytyczne ogólne

ECHA. Read-Across Assessment Framework (RAAF), ECHA-17-R-01-EN

WHO/FAO Pesticide Specifications. Manual on development and use of FAO and WHO specifications for chemical pesticides

EU Guidance Document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No 1107/2009 (SANCO/10597/2003)

ECHA Guidance on the Application of the CLP Criteria

—

—

—

—

—

—

—

—

OECD Guidance Document for flammability testing of plant protection and biocidal products. Series on Testing and Assessment, No 330

—

—

—

—

—

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)

—

—

—

—

EPPO Global Database on Crops and Pests (EPPO, 2017)

Baza danych dostępna w internecie: https://gd.eppo.int

—

—

—

—

—

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)

Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE/2017/10632)

Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830)

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.

Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE/2017/10632)

Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830)

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.

EU Working Document. Draft Guidance for the Setting and Application of Acceptable Operator Exposure Levels (AOEL’s) (SANCO/7531/2006)

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)

OECD Guidance for the Derivation of an Acute Reference Dose. Series on testing and assessment, No 124

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

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)

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

—

—

OECD Guidance document on acute oral toxicity testing. Series on Testing and Assessment, No 24

OECD Guidance Document on using Cytotoxicity Tests to Estimate Starting Doses for Acute Oral Systemic Toxicity Tests. Series on Testing and Assessment, No 129