Communication from the Commission in the framework of the implementation of Part A of the Annex of the Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance) 2023/C 344/02
Date: 2023-09-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: alternatives to animal testing, animal experimentation, market approval, plant health legislation, plant health product, testing








C_2023344EN.01003701.xml










29.9.2023   


EN


Official Journal of the European Union


C 344/37







Communication from the Commission in the framework of the implementation of Part A of the Annex of the Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
(Text with EEA relevance)
(2023/C 344/02)


This guidance has been developed in consultation with the Member States. It does not intend to produce any legally-binding effects and, by its nature, cannot prejudice any measure taken by a Member State in the implementation of Regulation (EC) No 1107/2009 of the European Parliament and of the Council
          (1)
, nor any case law developed with regard to this provision. Only the Court of Justice is empowered to authoritatively interpret and apply Union law.

The present Commission Communication fulfils Point 6 of the Introduction of the Annex to Commission Regulation (EU) No 283/2013 (2) that provides that, for purposes of information and of harmonisation, the list of test methods and guidance documents relevant to the implementation of this Regulation must be published in the Official Journal of the European Union. The Annexes below represent this list for Part A of the Annex to this Regulation and will be updated regularly.
Guidance documents and test methods (e.g. OECD) are referred to by their number and not by their year or revision number.
Listing of a document for a section means that it is relevant for all the sub-sections. In case there is no document listed for a section, no agreed test method or guidance document is currently available. In these cases, potential applicants should discuss proposals during the pre-submission meeting with the Rapporteur Member State and the European Food Safety Authority (EFSA), e.g. based on draft test methods.
To reduce testing on vertebrate animals, the Adverse Outcome Pathway approach is supported and relevant test methods and guidance documents are listed.

Test methods

Where Commission Regulation (EC) No 440/2008 (3) provides for a cross-reference to an OECD test method (by indicating that a test method is replicate, analogous to or equivalent to an OECD test method) in most cases only the OECD test guideline is listed to avoid duplication.
Only test methods that have been validated (e.g. ring-tested by OECD or equivalent international organisations) are listed. Test methods only described in scientific publications have not been included.
The listing of a test method should be read as referring to the most updated version of that test method available at the time of the initiation of a study.
In view of minimising testing on vertebrate animals, tests already carried out based on older test methods should be considered as part of the risk assessment, as provided for in Article 62 of Regulation (EC) No 1107/2009. However, during the pre-submission meeting, applicants, the Rapporteur Member State and EFSA may consider whether a new test according to newer test methods are needed, if scientifically justified.
In all cases, in accordance with Directive 2010/63/EU of the European Parliament and of the Council (4); Regulation (EC) No 1107/2009 (Recitals 11 and 40, Articles 8.1(d), 18(b), 33.3(c) and 62.1) and Regulation (EU) No 283/2013, unnecessary animal testing must be avoided. More specifically, Article 62 of Regulation (EC) No 1107/2009 provides that testing on vertebrate animals for the purposes of the approval of active substances for plant protection shall be undertaken only where no other methods are available. Alternative methods include in-vitro testing, in-silico methods or other approaches such as read-across, as described for instance in the EURL ECVAM Status report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches and the EURL ECVAM Status report on Non-animal Methods in Science and Regulation (5). Furthermore, availability of guidance documents on non-animal testing and validated in–vitro study protocols should be considered as a valid scientific justification (6) when considering point 1.5 of the Introduction of the Annex to Regulation (EU) No 283/2013.
If a new test is needed and several test methods are available to fulfil a data requirement, the order of test methods listed indicates a preference. The order prioritises methods where no or fewer test animals are needed and/or this method is associated with less severe suffering of the test animals. However, during the pre-submission meeting, upon advice by EFSA and the Rapporteur Member State, the order of priority can be changed when scientifically justified (e.g. due to limitations of the applicability domain of some methods) in order to ensure the scientific quality of the assessment.

Guidance documents

Guidance documents qualify to be listed when they:






—


have been endorsed by the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) before the publication of this Communication,










—


have been developed under the auspices of an official body (e.g. EFSA, the Commission, national authorities) with the aim to address a certain area of risk assessment or procedural issues, and were consulted with relevant stakeholders, or










—


have been endorsed by an intergovernmental organisation (such as OECD, FAO, WHO, or EPPO) where the Member States take part in the endorsement process.




Guidance documents not yet endorsed by the SCoPAFF before being listed under this Communication shall be considered endorsed with the endorsement of this Communication.
The following types of guidance documents have been listed:






—


Technical guidance documents, including guidance documents that are of horizontal nature that are relevant for several or all sections of the data requirements, including implementation of point 1.5 of the Introduction of the Annex to Regulation (EU) No 283/2013;










—


Administrative/procedural guidance documents if they are relevant for the implementation of the data requirements;










—


Models or calculation tools, if they are relevant for the data requirements and can be linked to or are supportive to a guidance document;










—


Scientific Opinions of the EFSA Panels and guidance documents from the interzonal Steering Committee relevant for all the Member States have been listed following a consideration on a case by case basis, if they are relevant for the implementation of specific data requirements.




Documents such as zonal guidance documents, EFSA statements, peer reviewed publications, technical reports, scientific reports, or strategies have not been listed.
The listing of a guidance document should be read as referring to the most updated version of that guidance document available at the time of the initiation of a study.


(1)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

(2)  Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1).

(3)  Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ( OJ L 142, 31.5.2008, p. 1).

(4)  Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

(5)  Available at https://publications.jrc.ec.europa.eu/repository/.

(6)  If relevant, see also: 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 (Annex 1, Annex 2); US EPA Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals and Supporting Retrospective Analysis (2020) ID: EPA 705-G-2020-3722; OECD Guideline No 497: Defined Approaches on Skin Sensitisation; 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 the Dendritic Cells on the Adverse Outcome Pathways for Skin Sensitisation; OECD Test No 236: Fish Embryo Acute Toxicity (FET) Test; OECD Test No 249: Fish Cell Line Acute Toxicity – The RTgill-W1 cell line assay.




ANNEX I

Guidance documents recommended for fulfilling the data requirements according to Regulation (EU) No 283/2013








Reference to Part A of the Annex to Regulation (EU) No 283/2013


Guidance documents


Notes





General guidance



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


 





General guidance



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)


 





General guidance



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


 





General guidance



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


 





General guidance



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


 





General guidance



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


 





General guidance



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)


 





General guidance



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


 





General guidance



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


 





General guidance



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


 





General guidance



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. No 19


 





General guidance



ECHA Guidance on the Application of the CLP Criteria


 





General guidance



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


 





General guidance



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


 





General guidance



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


 





General guidance



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)


 





General guidance



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)


 





General guidance



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


 





General guidance



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


 





General guidance



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


 





General guidance



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


 





General guidance



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


 





General guidance



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


 





General guidance



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)


 





General guidance



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


 










1.


IDENTITY OF THE ACTIVE SUBSTANCE






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


 










1.


IDENTITY OF THE ACTIVE SUBSTANCE






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


 










2.


PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE






ECHA Guidance on the Application of the CLP Criteria


 










2.1.


Melting point and boiling point






—


 










2.2.


Vapour pressure, volatility






—


 










2.3.


Appearance (physical state, colour)






—


 










2.4.


Spectra (UV/VIS, IR, NMR, MS), molar extinction at relevant wavelengths, optical purity






—


 










2.5.


Solubility in water






—


 










2.6.


Solubility in organic solvents






—


 










2.7.


Partition coefficient n-octanol/water






—


 










2.8.


Dissociation in water






—


 










2.9.


Flammability and self-heating






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


 










2.10.


Flash point






—


 










2.11.


Explosive properties






—


 










2.12.


Surface tension






—


 










2.13.


Oxidising properties






—


 










2.14.


Other studies






—


 










3.


FURTHER INFORMATION ON THE ACTIVE SUBSTANCE






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)


 










3.1.


Use of the active substance






—


 










3.2.


Function






—


 










3.3.


Effects on harmful organisms






—


 










3.4.


Field of use envisaged






—


 










3.5.


Harmful organisms controlled and crops or products protected or treated






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


Database available online: https://gd.eppo.int










3.6.


Mode of action






—


 










3.7.


Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies






—


 










3.8.


Methods and precautions concerning handling, storage, transport or fire






—


 










3.9.


Procedures for destruction or decontamination






—


 










3.10.


Emergency measures in case of an accident






—


 










4.


ANALYTICAL METHODS






 


 










4.1.


Methods used for the generation of pre-approval data






 


 










4.1.1.


Methods for the analysis of the active substance 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)


 










4.1.2.


Methods for the risk assessment






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


 










4.1.2.


Methods for the risk assessment






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


 










4.1.2.


Methods for the risk assessment






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.


 










4.2.


Methods for post-approval control and monitoring purposes






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


 










4.2.


Methods for post-approval control and monitoring purposes






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


 










4.2.


Methods for post-approval control and monitoring purposes






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.


 










5.


TOXICOLOGICAL AND METABOLISM STUDIES






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


 










5.


TOXICOLOGICAL AND METABOLISM STUDIES






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)


 










5.


TOXICOLOGICAL AND METABOLISM STUDIES






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


 










5.1.


Studies on absorption, distribution, metabolism and excretion in mammals






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


 










5.1.


Studies on absorption, distribution, metabolism and excretion in mammals






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)


 










5.1.


Studies on absorption, distribution, metabolism and excretion in mammals






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


 










5.1.1.


Absorption, distribution, metabolism and excretion by oral route






—


 










5.1.2.


Absorption, distribution, metabolism and excretion by other routes






—


 










5.2.


Acute toxicity






 


 










5.2.1.


Oral






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


 










5.2.1.


Oral






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


 










5.2.2.


Dermal






—


 










5.2.3.


Inhalation






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


 










5.2.3.


Inhalation






OECD Guidance document on inhalation toxicity studies. Series on testing and assessment, No 39


 










5.2.4.


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


 










5.2.5.


Eye irritation






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


 










5.2.5.


Eye irritation






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.


 










5.2.6.


Skin sensitisation






—


 










5.2.7.


Phototoxicity






ICH Safety Guidelines S10 Photosafety Evaluation of Pharmacetuticals


 










5.3.


Short-term toxicity






OECD Guidance Notes for Analysis and Evaluation of Repeat-Dose Toxicity Studies. Series on Testing and Assessment, No 32


 










5.3.1.


Oral 28-day study






—


 










5.3.2.


Oral 90-day study






—


 










5.3.3.


Other routes






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


 










5.4.


Genotoxicity testing






EFSA Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment. (EFSA Journal 2011;9(9):2379)


 










5.4.


Genotoxicity testing






EFSA Scientific Opinion, Clarification of some aspects related to genotoxicity assessment (EFSA Journal 2017;15(12):5113)


 










5.4.


Genotoxicity testing






EFSA Guidance on aneugenicity assessment (PAFF-PPL-May22-Doc.A.07.02, EFSA Journal 2021;19(8):6770)


 










5.4.


Genotoxicity testing






ICH Safety Guidelines S10 Photosafety Evaluation of Pharmacetuticals


 










5.4.1.



In vitro studies






—


 










5.4.2.



In vivo studies in somatic cells






—


 










5.4.3.



In vivo studies in germ cells






—


 










5.5.


Long term toxicity and carcinogenicity






OECD Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting Test Guidelines 451, 452 and 453


 










5.6.


Reproductive toxicity






OECD Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting Test Guidelines 451, 452 and 453


 










5.6.


Reproductive toxicity






OECD Guidance Document for Histologic Evaluation of Endocrine and Reproductive Tests in Rodents. Series on Testing and Assessment, No 106


 










5.6.


Reproductive toxicity






OECD Guidance Document on Mammalian Reproductive Toxicity Testing and Assessment. Series on Testing and Assessment, No 43


 










5.6.1.


Generational studies






—


 










5.6.2.


Developmental toxicity studies






North American Free Trade Agreement (NAFTA) Technical Working Group on Pesticides (TWG) Developmental Neurotoxicity Study Guidance Document


 










5.6.2.


Developmental toxicity studies






OECD Developmental Neurotoxicity Study (OECD TG 426), Chapter 3.8 in Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption


 










5.7.


Neurotoxicity studies






OECD Guidance Document for Neurotoxicity Testing. Series on Testing and Assessment, No 20


 










5.7.1.


Neurotoxicity studies in rodents






—


 










5.7.2.


Delayed polyneuropathy studies






—


 










5.8.


Other toxicological studies






—


 










5.8.1.


Toxicity studies of metabolites






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)


 










5.8.2.


Supplementary studies on the active substance






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


 










5.8.3.


Endocrine disrupting properties






Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 (C/2018/6040)


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.










5.8.3.


Endocrine disrupting properties






OECD Revised Guidance Document No 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption


This guidance contains information about the relevant test methods and is regularly updated.










5.9.


Medical data






—


 










6.


RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED






OECD Guidance Document on Overview of Residue Chemistry Studies. Series on Testing and Assessment, No 64 and Series on Pesticides, No 32


This document is partially outdated.










6.1.


Storage stability of residues






—


 










6.2.


Metabolism, distribution and expression of residues






 


 










6.2.1.


Plants






—


 










6.2.2.


Poultry






—


 










6.2.3.


Lactating ruminants






—


 










6.2.4.


Pigs






—


 










6.2.5.


Fish






—


 










6.3.


Magnitude of residues in plants






OECD Guidance Document on Crop Field Trials. Series on Testing and Assessment, No 164 and Series on Pesticides, No 66


 










6.3.


Magnitude of residues in plants






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)


 










6.4.


Feeding studies






OECD Guidance Document on Residues in Livestock. Series on Pesticides, No 73


 










6.4.


Feeding studies






EFSA Estimation of animal intakes and HR, STMR and MRL calculations for products of animal origin


 










6.4.


Feeding studies






EFSA Spreadsheet for HR, STMR and MRL calculations for products of animal origin; EU Animal burden calculator – animals


 










6.4.1.


Poultry






—


 










6.4.2.


Ruminants






—


 










6.4.3.


Pigs






—


 










6.4.4.


Fish






—


 










6.5.


Effects of processing






—


 










6.5.1.


Nature of the residue






—


 










6.5.2.


Distribution of the residue in inedible peel and pulp






—


 










6.5.3.


Magnitude of residues in processed commodities






OECD Guidance document on magnitude of pesticide residues in processed commodities. Environment, Health and Safety Publications. Series on Testing and Assessment, No 96


 










6.6.


Residues in rotational crops






OECD Guidance document on residues in rotational crops. Series on Pesticides, No 97. and Series on Testing and Assessment, No. 279


 










6.6.1.


Metabolism in rotational crops






—


 










6.6.2.


Magnitude of residues in rotational crops






—


 










6.7.


Proposed residue definition and maximum residue levels






—


 










6.7.1.


Proposed residue definitions






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


 










6.7.2.


Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed






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)


 










6.7.2.


Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed






OECD MRL calculator: user guide


 










6.7.3.


Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed for imported products (import tolerance)






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)


 










6.7.3.


Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed for imported products (import tolerance)






OECD MRL calculator: user Guide


 










6.8.


Proposed safety intervals






EU guidance document ‘Calculation of Maximum Residue Levels and Safety Intervals e.g. Pre-harvest Intervals’ (SANCO 7039/VI/95)


Only applicable for PHI classes










6.9.


Estimation of the potential and actual exposure through diet and other sources






EFSA calculation model Pesticide Residue Intake Model ‘PRIMo’


 










6.9.


Estimation of the potential and actual exposure through diet and other sources






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 )


 










6.9.


Estimation of the potential and actual exposure through diet and other sources






WHO Guidelines for drinking water quality


 










6.10.


Other studies






—


 










6.10.1.


Effect on the residue level in pollen and bee products






EU guidance document ‘Technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels in honey’ (SANTE/11956/2016 )


 










7.


FATE AND BEHAVIOUR IN THE ENVIRONMENT






—


 










7.1.


Fate and behaviour in soil






—


 










7.1.1.


Route of degradation in soil






—


 










7.1.1.1.


Aerobic degradation






—


 










7.1.1.2.


Anaerobic degradation






—


 










7.1.1.3.


Soil photolysis






SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides


 










7.1.1.3.


Soil photolysis






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)


 










7.1.2.


Rate of degradation in soil






—


 










7.1.2.


Rate of degradation in soil







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))


The generic FOCUS guidance documents that are based on the relevant, more specific guidance documents and regularly updated are listed.










7.1.2.


Rate of degradation in soil






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


 










7.1.2.


Rate of degradation in soil







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))


The generic FOCUS guidance documents that are based on the relevant, more specific guidance documents and regularly updated are listed.










7.1.2.1.


Laboratory studies






—


 










7.1.2.2.


Field studies






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


 










7.1.3.


Adsorption and desorption in soil







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))


The generic FOCUS guidance documents that are based on the relevant, more specific guidance documents and regularly updated are listed.










7.1.3.1.


Adsorption and desorption






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


 










7.1.3.2.


Aged sorption






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


 










7.1.4.


Mobility in soil






—


 










7.1.4.1.


Column leaching studies






—


 










7.1.4.2.


Lysimeter studies






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)


 










7.1.4.3.


Field leaching studies






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)


 










7.2.


Fate and behaviour in water and sediment






—


 










7.2.1.


Route and rate of degradation in aquatic systems (chemical and photochemical degradation)






—


 










7.2.1.1.


Hydrolytic degradation






—


 










7.2.1.2.


Direct photochemical degradation






—


 










7.2.1.3.


Indirect photochemical degradation






—


 










7.2.2.


Route and rate of biological degradation in aquatic systems






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


 










7.2.2.1.


‘Ready biodegradability’






—


 










7.2.2.2.


Aerobic mineralisation in surface water






 


 










7.2.2.3.


Water/sediment study







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))


The generic FOCUS guidance documents that are based on the relevant, more specific guidance documents and regularly updated are listed.










7.2.2.4.


Irradiated water/sediment study






—


 










7.2.3.


Degradation in the saturated zone






—


 










7.3.


Fate and behaviour in air






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


 










7.3.1.


Route and rate of degradation in air






—


 










7.3.2.


Transport via air






—


 










7.3.3.


Local and global effects






—


 










7.4.


Definition of the residue






—


 










7.4.1.


Definition of the residue for risk assessment






—


 










7.4.2.


Definition of the residue for monitoring






—


 










7.5.


Monitoring data






—


 










8.


ECOTOXICOLOGICAL STUDIES






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


 










8.1.


Effects on birds and other terrestrial vertebrates






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


 










8.1.1.


Effects on birds






—


 










8.1.1.1.


Acute oral toxicity to birds






—


 










8.1.1.2.


Short-term dietary toxicity to birds






—


 










8.1.1.3.


Sub-chronic and reproductive toxicity to birds






—


 










8.1.2.


Effects on terrestrial vertebrates other than birds






—


 










8.1.2.1.


Acute oral toxicity to mammals






—


 










8.1.2.2.


Long-term and reproductive toxicity to mammals






—


 










8.1.3.


Active substance bioconcentration in prey of birds and mammals






—


 










8.1.4.


Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)






—


 










8.1.5.


Endocrine disrupting properties






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)


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.










8.1.5.


Endocrine disrupting properties






OECD Revised Guidance Document No 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption


This guidance contains information about the relevant test methods and is regularly updated.










8.2.


Effects on aquatic organisms






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)


 










8.2.1.


Acute toxicity to fish






OECD Short guidance on the threshold approach for acute fish toxicity. Series on Testing and Assessment, No 126


 










8.2.1.


Acute toxicity to fish






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)


 










8.2.2.


Long-term and chronic toxicity to fish






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)


 










8.2.2.1.


Fish early life stage toxicity test






—


 










8.2.2.2.


Fish full life cycle test






—


 










8.2.2.3.


Bioconcentration in fish






—


 










8.2.3.


Endocrine disrupting properties






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)


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.










8.2.3.


Endocrine disrupting properties






OECD Revised Guidance Document No 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption


This guidance contains information about the relevant test methods and is regularly updated.










8.2.4.


Acute toxicity to aquatic invertebrates






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)


 










8.2.4.1.


Acute toxicity to Daphnia magna







—


 










8.2.4.2.


Acute toxicity to an additional aquatic invertebrate species






—


 










8.2.5.


Long-term and chronic toxicity to aquatic invertebrates






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)


 










8.2.5.1.


Reproductive and development toxicity to Daphnia magna







—


 










8.2.5.2.


Reproductive and development toxicity to an additional aquatic invertebrate species






—


 










8.2.5.3.


Development and emergence in Chironomus riparius







—


 










8.2.5.4.


Sediment dwelling organisms






—


 










8.2.6.


Effects on algal growth






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)


 










8.2.6.1.


Effects on growth of green algae






—


 










8.2.6.2.


Effects on growth of an additional algal species






—


 










8.2.7.


Effects on aquatic macrophytes






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)


 










8.2.8.


Further testing on aquatic organisms






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)


 










8.3.


Effect on arthropods






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


 










8.3.1.


Effects on bees






—


 










8.3.1.1.


Acute toxicity to bees






—


 










8.3.1.1.1.


Acute oral toxicity






—


 










8.3.1.1.2.


Acute contact toxicity






—


 










8.3.1.2.


Chronic toxicity to bees






—


 










8.3.1.3.


Effects on honeybee development and other honeybee life stages






—


 










8.3.1.4.


Sub-lethal effects






—


 










8.3.2.


Effects on non-target arthropods other than bees






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


 










8.3.2.


Effects on non-target arthropods other than bees






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


 










8.3.2.1.


Effects on Aphidius rhopalosiphi







—


 










8.3.2.2.


Effects on Typhlodromus pyri







—


 










8.4.


Effects on non-target soil meso- and macrofauna






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


 










8.4.


Effects on non-target soil meso- and macrofauna






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


 










8.4.1.


Earthworm – sub-lethal effects






—


 










8.4.2.


Effects on non-target soil mesofauna (other than earthworms)






—


 










8.4.2.1.


Species level testing






—


 










8.5.


Effects on soil nitrogen transformation






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


 










8.6.


Effects on terrestrial non-target higher plants






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


 










8.6.1.


Summary of screening data






—


 










8.6.2.


Testing on non-target plants






—


 










8.7.


Effects on other terrestrial organisms (flora and fauna)






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


 










8.8.


Effects on biological methods for sewage treatment






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


 










9.


LITERATURE DATA






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)


 










9.


LITERATURE DATA






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


 










10.


CLASSIFICATION AND LABELLING






ECHA Guidance on the Application of the CLP Criteria


 









ANNEX II

Test methods recommended for fulfilling the data requirements according to Regulation (EU) No 283/2013








Reference to Part A of the Annex to Regulation (EU) No 283/2013


Test methods


Notes





Guidance for certain classes of substances



—


 










1.


IDENTITY OF THE ACTIVE SUBSTANCE






—


 










2.


PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE






—


 










2.1.


Melting point and boiling point






OECD Test Guideline 102: Melting Point/Melting Range


 










2.1.


Melting point and boiling point






OECD Test Guideline 103: Boiling point


 










2.2.


Vapour pressure, volatility






OECD Test Guideline 104: Vapour Pressure


 










2.3.


Appearance (physical state, colour)






—


 










2.4.


Spectra (UV/VIS, IR, NMR, MS), molar extinction at relevant wavelengths, optical purity






OECD Test Guideline 101: UV-VIS Absorption Spectra


 










2.5.


Solubility in water






OECD Test Guideline 105: Water Solubility


 










2.5.


Solubility in water






Method A.6: Water solubility, Part A of Regulation (EC) No 440/2008


 










2.6.


Solubility in organic solvents






CIPAC Method MT 181: Solubility in organic solvents


 










2.6.


Solubility in organic solvents






CIPAC Method MT 157: Water solubility


May be adapted in some circumstances.










2.6.


Solubility in organic solvents






OECD Test Guideline 105: Water Solubility


May be adapted in some circumstances.










2.7.


Partition coefficient n-octanol/water






OECD Test Guideline 107: Partition coefficient, shake-flask method


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.










2.7.


Partition coefficient n-octanol/water






OECD Test Guideline 117: Partition Coefficient (n-octanol/water), HPLC method


 










2.7.


Partition coefficient n-octanol/water






OECD Test Guideline 123: Partition coefficient (1-octanol/water): slow-stirring method


 










2.7.


Partition coefficient n-octanol/water






Method A.23: Partition coefficient (1-octanol/water): Slow stirring method, Part A of Regulation (EC) No 440/2008


 










2.7.


Partition coefficient n-octanol/water






Method A.24: Partition coefficient (n-octanol/water), High performance liquid chromatography (HPLC) method, Part A of Regulation (EC) No 440/2008


 










2.8.


Dissociation in water






OECD Test Guideline 112: Dissociation Constants in Water


 










2.9.


Flammability and self-heating – Flammability






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


 










2.9.


Flammability and self-heating – Flammability






Method A.15: Auto-ignition temperature (liquids and gases), Part A of Regulation (EC) No 440/2008


 










2.9.


Flammability and self-heating – Flammability






Method A.16: Relative self-ignition temperature for solids, Part A of Regulation (EC) No 440/2008


 










2.9.


Flammability and self-heating – Flammability






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


 










2.9.


Flammability and self-heating – Flammability






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


 










2.9.


Flammability and self-heating – Flammability






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


 










2.9.


Flammability and self-heating – Flammability






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


 










2.9.


Flammability and self-heating – Flammability






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


 










2.9.


Flammability and self-heating – Flammability






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


 










2.9.


Flammability and self-heating – Self-heating






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


 










2.9.


Flammability and self-heating – Self-heating






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


 










2.9.


Flammability and self-heating – Self-heating






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


 










2.10.


Flash point






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


 










2.10.


Flash point






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


Only closed cup methods should be used.










2.10.


Flash point






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


 










2.11.


Explosive properties






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


 










2.11.


Explosive properties






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


 










2.12.


Surface tension






OECD Test Guideline 115: Surface tension of aqueous solutions


 










2.12.


Surface tension






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


 










2.13.


Oxidising properties






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


 










2.13.


Oxidising properties






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


 










2.13.


Oxidising properties






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


 










2.13.


Oxidising properties






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


 










2.13.


Oxidising properties






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


 










2.13.


Oxidising properties






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


 










2.13.


Oxidising properties






Transport of Dangerous Goods (UN RTDG) Manual of Tests and Criteria ST/SG/AC.10/11/


 










2.14.


Other studies






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


 










3.


FURTHER INFORMATION ON THE ACTIVE SUBSTANCE






EPPO standard series PP1: Efficacy evaluation of plant protection products


Please consider only those uses which are deemed relevant under the scope of Regulation (EC) No 1107/2009, and not those in EPPO PP1/248 which refer to biostimulant claims as defined both under the scope of Regulation (EU) 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.










3.1.


Use of the active substance






—


 










3.2.


Function






—


 










3.3.


Effects on harmful organisms






—


 










3.4.


Field of use envisaged






—


 










3.5.


Harmful organisms controlled and crops or products protected or treated






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


Database available online: https://gd.eppo.int










3.6.


Mode of action






—


 










3.7.


Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies






EPPO standard PP1/213: Resistance risk analysis


 










3.8.


Methods and precautions concerning handling, storage, transport or fire






—


 










3.9.


Procedures for destruction or decontamination






—


 










3.10.


Emergency measures in case of an accident






—


 










4.


ANALYTICAL METHODS






—


 










5.


TOXICOLOGICAL AND METABOLISM STUDIES






—


 










5.1.


Studies on absorption, distribution, metabolism and excretion in mammals






OECD Test Guideline 417: Toxicokinetics


 










5.1.1.


Absorption, distribution, metabolism and excretion by oral route






 


 










5.1.2.


Absorption, distribution, metabolism and excretion by other routes






 


 










5.2.


Acute toxicity






—


 










5.2.1.


Oral






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


 










5.2.1.


Oral






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


 










5.2.1.


Oral






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


 










5.2.1.


Oral






OECD Test Guideline No 401: Acute oral toxicity


Only acceptable, if performed before December 2002.










5.2.2.


Dermal






OECD Test Guideline 402: Acute Dermal Toxicity


 










5.2.3.


Inhalation






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


 










5.2.3.


Inhalation






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


 










5.2.3.


Inhalation






OECD Test Guideline 403: Acute Inhalation Toxicity


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.










5.2.4.


Skin irritation






OECD Test Guideline 431: In vitro Skin Corrosion: reconstructed human epidermis (RHE) test methodt


 










5.2.4.


Skin irritation






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


 










5.2.4.


Skin irritation






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


 










5.2.4.


Skin irritation






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


 










5.2.4.


Skin irritation






OECD Test Guideline 404: Acute Dermal Irritation/Corrosion


 










5.2.5.


Eye irritation






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


 










5.2.5.


Eye irritation






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


 










5.2.5.


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


 










5.2.5.


Eye irritation






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


 










5.2.5.


Eye irritation






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


 










5.2.5.


Eye irritation






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


 










5.2.5.


Eye irritation






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


 










5.2.5.


Eye irritation






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


 










5.2.5.


Eye irritation






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


 










5.2.5.


Eye irritation






OECD Test Guideline 405: Acute eye irritation/corrosion


 










5.2.6.


Skin sensitisation






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


 










5.2.6.


Skin sensitisation






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


 










5.2.6.


Skin sensitisation






OECD Test Guideline 406: Skin sensitisation


As the Buehler test is considered less sensitive than the maximization test, there is a preference of choice of assay for the maximisation test










5.2.6.


Skin sensitisation






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


 










5.2.7.


Phototoxicity






OECD Test Guideline 101: UV-VIS Absorption Spectra


 










5.2.7.


Phototoxicity






OECD Test No 495: Ros (Reactive Oxygen Species) Assay for Photoreactivity


 










5.2.7.


Phototoxicity






OECD Test Guideline 432: In vitro 3T3 NRU Phototoxicity Test


 










5.2.7.


Phototoxicity






OECD Test No 498: In vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity test method


 










5.3.


Short-term toxicity






OECD Test Guideline 422: Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test


 










5.3.


Short-term toxicity






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


 










5.3.1.


Oral 28-day study






OECD Test Guideline 407: Repeated dose 28-day oral toxicity study in rodents


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.










5.3.2.


Oral 90-day study






OECD Test Guideline 408: Repeated dose 90-day oral toxicity study in rodents


 










5.3.2.


Oral 90-day study






OECD Test Guideline 409: Repeated dose 90-day oral toxicity study in non-rodents


 










5.3.3.


Other routes






OECD Test Guideline 410: Repeated dose dermal toxicity: 21/28-day study


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.










5.3.3.


Other routes






OECD Test Guideline 411: Subchronic dermal toxicity: 90-day study


 










5.3.3.


Other routes






OECD Test Guideline 412: Subacute inhalation toxicity: 28-day study


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.










5.3.3.


Other routes






OECD Test Guideline 413: Subchronic inhalation toxicity: 90-day study


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.










5.4.


Genotoxicity testing






—


 










5.4.1.



In vitro studies






OECD Test Guideline 471: Bacterial Reverse Mutation Test


 










5.4.1.



In vitro studies






OECD Test Guideline 487 In vitro Mammalian Cell Micronucleus Test


 










5.4.1.



In vitro studies






OECD Test Guideline 473: In vitro Mammalian Chromosome Aberration Test


 










5.4.1.



In vitro studies






OECD Test Guideline 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes


 










5.4.1.



In vitro studies






OECD Test Guideline 490: In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene


 










5.4.2.



In vivo studies in somatic cells






OECD 470 Test Guideline on the Mammalian Erythrocyte Pig-a Gene Mutation Assay


The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested










5.4.2.



In vivo studies in somatic cells






OECD Test Guideline 474: Mammalian Erythrocyte Micronucleus Test


The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested










5.4.2.



In vivo studies in somatic cells






OECD Test Guideline 475: Mammalian Bone Marrow Chromosome Aberration Test


The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested










5.4.2.



In vivo studies in somatic cells






OECD Test Guideline 486: Unscheduled DNA synthesis (UDS) – Test with mammalian liver cells in vivo



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).










5.4.2.



In vivo studies in somatic cells






OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays


The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested.










5.4.2.



In vivo studies in somatic cells






OECD test guideline 489: In Vivo Mammalian Alkaline Comet Assay


The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested.










5.4.3.



In vivo studies in germ cells






OECD Test Guideline 483: Mammalian Spermatogonial Chromosome Aberration Test


The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested.










5.4.3.



In vivo studies in germ cells






OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays


The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested.










5.4.3.



In vivo studies in germ cells






OECD Test Guideline 478: Rodent Dominant Lethal Test


The possibility of integrating in vivo genotoxicity testing with repeated dose toxicity studies should be explored to reduce the number of animals tested.










5.5.


Long term toxicity and carcinogenicity






OECD Test Guideline 453: Combined Chronic Toxicity/Carcinogenicity Studies


 










5.5.


Long term toxicity and carcinogenicity






OECD Test Guideline 451: Carcinogenicity Studies


 










5.5.


Long term toxicity and carcinogenicity






OECD Test Guideline 452: Chronic Toxicity Studies


 










5.6.


Reproductive toxicity






OECD Series on Testing and Assessment No 151: Guidance document supporting OECD test guideline 443 on the extended one-generation reproductive toxicity test


 










5.6.1.


Generational studies






OECD Test Guideline 443: Extended One-generation Reproductive Toxicity


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 .










5.6.1.


Generational studies






OECD Test Guideline 416: Two-Generation Reproduction Toxicity


It has been only listed, as it was used in the past. Preference should be given to the EOGRTS.










5.6.2.


Developmental toxicity studies






OECD Test Guideline 414: Prenatal developmental toxicity study


 










5.6.2.


Developmental toxicity studies






OECD Test Guideline 426: Developmental neurotoxicity study


 










5.7.


Neurotoxicity studies






—


 










5.7.1.


Neurotoxicity studies in rodents






OECD Test Guideline 424: Neurotoxicity study in rodents


 










5.7.2.


Delayed polyneuropathy studies






OECD Test Guideline 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure


 










5.7.2.


Delayed polyneuropathy studies






OECD Test Guideline 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study


 










5.8.


Other toxicological studies






—


 










5.8.1.


Toxicity studies of metabolites






—


 










5.8.2.


Supplementary studies on the active substance






Health Effects Test Guidelines: OPPTS 870.7800 Immunotoxicity [EPA 712–C–98–351]


Conditional requirement: only if effects indicate immunotoxicological potential observed in toxicological and metabolism studies










5.8.2.


Supplementary studies on the active substance






ICH Safety Guidelines S8 Immunotoxicity Studies for Human Pharmacetuticals


 










5.8.3.


Endocrine disrupting properties






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


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










5.9.


Medical data






—


 










6.


RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED






—


 










6.1.


Storage stability of residues






OECD Test Guideline 506: Stability of Pesticide Residues in Stored Commodities


 










6.2.


Metabolism, distribution and expression of residues






—


 










6.2.1.


Plants






OECD Test Guideline 501: Metabolism in crops


 










6.2.2.


Poultry






OECD Test Guideline 503: Metabolism in livestock


 










6.2.3.


Lactating ruminants






OECD Test Guideline 503: Metabolism in livestock


 










6.2.4.


Pigs






OECD Test Guideline 503: Metabolism in livestock


 










6.2.5.


Fish






 


 










6.3.


Magnitude of residues in plants






OECD Test Guideline 509: Crop field trials


 










6.4.


Feeding studies






—


 










6.4.1.


Poultry






OECD Test Guideline 505: Residues in livestock


 










6.4.2.


Ruminants






OECD Test Guideline 505: Residues in livestock


 










6.4.3.


Pigs






OECD Test Guideline 505: Residues in livestock


 










6.4.4.


Fish






—


 










6.5.


Effects of processing






—


 










6.5.1.


Nature of the residue






OECD Test Guideline 507: Nature of the pesticide residues in processed commodities – High temperature hydrolysis


 










6.5.2.


Distribution of the residue in inedible peel and pulp






OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities


 










6.5.2.


Distribution of the residue in inedible peel and pulp






OECD Test Guideline 509: Crop field trials


 










6.5.3.


Magnitude of residues in processed commodities






OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities


 










6.6.


Residues in rotational crops






—


 










6.6.1.


Metabolism in rotational crops






OECD Test Guideline 502: Metabolism in rotational crops


 










6.6.2.


Magnitude of residues in rotational crops






OECD Test Guideline 504: Residues in rotational crops (limited field studies)


 










6.6.2.


Magnitude of residues in rotational crops






OECD Test Guideline 509: Crop field trials


 










6.7.


Proposed residue definition and maximum residue levels






—


 










6.7.1.


Proposed residue definitions






—


 










6.7.2.


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)






—


 










6.8.


Proposed safety intervals






—


 










6.9.


Estimation of the potential and actual exposure through diet and other sources






—


 










6.10.


Other studies






—


 










6.10.1.


Effect on the residue level in pollen and bee products






EU guidance document ‘Technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels in honey’ (SANTE/11956/2016 )


 










7.


FATE AND BEHAVIOUR IN THE ENVIRONMENT






—


 










7.1.


Fate and behaviour in soil






OECD Test Guideline 307: Aerobic and anaerobic transformation in soil


 










7.1.


Fate and behaviour 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


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










7.1.


Fate and behaviour in soil






ISO 18400-102:2017
ISO 18400-104:2018
ISO 18400-105:2017
ISO 18400-206:2018


 










7.1.1.


Route of degradation in soil






—


 










7.1.1.1.


Aerobic degradation






OECD Test Guideline 307: Aerobic and anaerobic transformation in soil


 










7.1.1.2.


Anaerobic degradation






OECD Test Guideline 307: Aerobic and anaerobic transformation in soil


 










7.1.1.3.


Soil photolysis






US EPA Test Guideline OPPTS 835.2410 Photodegradation on Soil. EPA 712-C-08-015, October 2008


 










7.1.2.


Rate of degradation in soil






—


 










7.1.2.1.


Laboratory studies






OECD Test Guideline 307: Aerobic and anaerobic transformation in soil


 










7.1.2.2.


Field studies






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


 










7.1.2.2.


Field studies






US EPA OCSPP 835.6100: Terrestrial field dissipation


 










7.1.3.


Adsorption and desorption in soil






—


 










7.1.3.1.


Adsorption and desorption






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


 










7.1.3.1.


Adsorption and desorption






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


 










7.1.3.2.


Aged sorption






—


 










7.1.4.


Mobility in soil






—


 










7.1.4.1.


Column leaching studies






OECD Test Guideline 312: Leaching in Soil Columns


 










7.1.4.2.


Lysimeter studies






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


 










7.1.4.3.


Field leaching studies






—


 










7.2.


Fate and behaviour in water and sediment






—


 










7.2.1.


Route and rate of degradation in aquatic systems (chemical and photochemical degradation)






—


 










7.2.1.1.


Hydrolytic degradation






OECD Test Guideline 111: Hydrolysis as a Function of pH


 










7.2.1.2.


Direct photochemical degradation






OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis


 










7.2.1.3.


Indirect photochemical degradation






—


 










7.2.2.


Route and rate of biological degradation in aquatic systems






—


 










7.2.2.1.


‘Ready biodegradability’






OECD Guideline Test 301: Ready Biodegradability (301 A - F)


 










7.2.2.1.


‘Ready biodegradability’






OECD Test Guideline 310: Ready Biodegradability – CO2 in sealed vessels (Headspace Test)


 










7.2.2.2.


Aerobic mineralisation in surface water






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


 










7.2.2.3.


Water/sediment study






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


 










7.2.2.4.


Irradiated water/sediment study






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


 










7.2.3.


Degradation in the saturated zone






—


 










7.3.


Fate and behaviour in air






—


 










7.3.1.


Route and rate of degradation in air






—


 










7.3.2.


Transport via air






—


 










7.3.3.


Local and global effects






—


 










7.4.


Definition of the residue






—


 










7.4.1.


Definition of the residue for risk assessment






—


 










7.4.2.


Definition of the residue for monitoring






—


 










7.5.


Monitoring data






—


 










8.


ECOTOXICOLOGICAL STUDIES






—


 










8.1.


Effects on birds and other terrestrial vertebrates






—


 










8.1.1.


Effects on birds






—


 










8.1.1.1.


Acute oral toxicity to birds






OECD Test Guideline 223: Avian acute oral toxicity study


 










8.1.1.1.


Acute oral toxicity to birds






US EPA OCSPP 850.2100: Avian oral toxicity test


 










8.1.1.2.


Short-term dietary toxicity to birds






OECD Test Guideline 205: Avian Dietary Toxicity Test


 










8.1.1.2.


Short-term dietary toxicity to birds






US EPA OCSPP 850.2200: Avian dietary toxicity test


 










8.1.1.3.


Sub-chronic and reproductive toxicity to birds






OECD Test Guideline 206: Avian Reproduction Test


 










8.1.1.3.


Sub-chronic and reproductive toxicity to birds






US EPA OCSPP 850.2300: Avian Reproduction Test


 










8.1.2.


Effects on terrestrial vertebrates other than birds






—


 










8.1.2.1.


Acute oral toxicity to mammals






Please, refer to 5.2.1


 










8.1.2.2.


Long-term and reproductive toxicity to mammals






Please, refer to 5.3.1, 5.3.2, 5.6.1 and 5.6.2


 










8.1.3.


Active substance bioconcentration in prey of birds and mammals






—


 










8.1.4.


Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)






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


 










8.1.4.


Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)






OECD Test Guideline 231: Amphibian Metamorphosis Assay


 










8.1.4.


Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)






OECD Test Guideline 241: Larval Amphibian Growth and Development Test


 










8.1.5.


Endocrine disrupting properties






Test guidelines are listed in OECD Revised Guidance Document No. 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption.


 










8.2.


Effects on aquatic organisms






—


 










8.2.1.


Acute toxicity to fish






OECD Test Guideline 203: Fish, Acute Toxicity Test


 










8.2.2.


Long-term and chronic toxicity to fish






—


 










8.2.2.1.


Fish early life stage toxicity test






OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test


 










8.2.2.1.


Fish early life stage toxicity test






OECD Test No 234: Fish Sexual Development Test


 










8.2.2.2.


Fish full life cycle test






US EPA protocol OCSPP 850.1500 Fish life cycle toxicity


 










8.2.2.3.


Bioconcentration in fish






OECD Test Guideline 305: Bioaccumulation in Fish: Aqueous and Dietary Exposure


 










8.2.3.


Endocrine disrupting properties






Test guidelines are listed in OECD Revised Guidance Document No 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption


 










8.2.4.


Acute toxicity to aquatic invertebrates






—


 










8.2.4.1.


Acute toxicity to Daphnia magna







OECD Test Guideline 202: Daphnia sp., Acute Immobilisation Test


 










8.2.4.2.


Acute toxicity to an additional aquatic invertebrate species






OECD Test Guideline 235: Chironomus sp., Acute Immobilisation Test


Only one of the three species needs to be tested.










8.2.4.2.


Acute toxicity to an additional aquatic invertebrate species






US EPA OCSPP 850.1035 Mysid Acute Toxicity Test


Only one of the three species needs to be tested.










8.2.4.2.


Acute toxicity to an additional aquatic invertebrate species






US EPA 850.1025 (Oyster acute toxicity test)


Only one of the three species needs to be tested.










8.2.5.


Long-term and chronic toxicity to aquatic invertebrates






—


 










8.2.5.1.


Reproductive and development toxicity to Daphnia magna







OECD Test Guideline 211: Daphnia magna Reproduction Test


 










8.2.5.2.


Reproductive and development toxicity to an additional aquatic invertebrate species






US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test


Only one of the three species needs to be tested.










8.2.5.2.


Reproductive and development toxicity to an additional aquatic invertebrate species






OECD Test Guideline 242: Potamopyrgus antipodarum Reproduction Test


Only one of the three species needs to be tested










8.2.5.2.


Reproductive and development toxicity to an additional aquatic invertebrate species






OECD Test Guideline 243: Lymnaea stagnalis Reproduction Test


Only one of the three species needs to be tested










8.2.5.3.


Development and emergence in Chironomus riparius







OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water


 










8.2.5.4.


Sediment dwelling organisms






OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment


 










8.2.5.4.


Sediment dwelling organisms






OECD Test Guideline 233: Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment


 










8.2.5.4.


Sediment dwelling organisms






OECD Test Guideline 225: Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment


 










8.2.6.


Effects on algal growth






—


 










8.2.6.1.


Effects on growth of green algae






OECD Test Guideline 201: Algae growth inhibition test


 










8.2.6.2.


Effects on growth of an additional algal species






OECD Test Guideline 201: Algae growth inhibition test


 










8.2.7.


Effects on aquatic macrophytes






OECD Test Guideline 221: Lemna sp. Growth Inhibition Test


 










8.2.7.


Effects on aquatic macrophytes






ASTM E1913-04: Standard Guide for Conducting Static, Axenic, 14-Day Phytotoxicity Tests in Test Tubes with the Submersed Aquatic Macrophyte, Myriophyllum sibiricum Komarov



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.










8.2.7.


Effects on aquatic macrophytes






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, pp. 46-56


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.










8.2.7.


Effects on aquatic macrophytes






OECD Test Guideline 238: Sediment-Free Myriophyllum Spicatum Toxicity Test


 










8.2.7.


Effects on aquatic macrophytes






OECD Test Guideline 239: Water-Sediment Myriophyllum Spicatum Toxicity Test


 










8.2.8.


Further testing on aquatic organisms






—


 










8.3.


Effect on arthropods






—


 










8.3.1.


Effects on bees






—


 










8.3.1.1.


Acute toxicity to bees






—


 










8.3.1.1.1.


Acute oral toxicity






EPPO 170(4) Side-effects on honeybees


 










8.3.1.1.1.


Acute oral toxicity






OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test


 










8.3.1.1.1.


Acute oral toxicity






OECD Test Guideline 247: Bumblebee, Acute Oral Toxicity Test


 










8.3.1.1.2.


Acute contact toxicity






EPPO 170(4) Side-effects on honeybees


 










8.3.1.1.2.


Acute contact toxicity






OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test


 










8.3.1.1.2.


Acute contact toxicity






OECD Test Guideline 246: Bumblebee, Acute Contact Toxicity Test


 










8.3.1.2.


Chronic toxicity to bees






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


 










8.3.1.3.


Effects on honeybee development and other honeybee life stages






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


 










8.3.1.3.


Effects on honeybee development and other honeybee life stages






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


 










8.3.1.3.


Effects on honeybee development and other honeybee life stages






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


 










8.3.1.3.


Effects on honeybee development and other honeybee life stages






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


 










8.3.1.3.


Effects on honeybee development and other honeybee life stages






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


 










8.3.1.4.


Sub-lethal effects






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


 










8.3.2.


Effects on non-target arthropods other than bees






 


 










8.3.2.1.


Effects on Aphidius rhopalosiphi







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


 










8.3.2.2.


Effects on Typhlodromus pyri







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


 










8.4.


Effects on non-target soil meso- and macrofauna






—


 










8.4.1.


Earthworm – sub-lethal effects






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


 










8.4.1.


Earthworm – sub-lethal effects






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


 










8.4.1.


Earthworm – sub-lethal effects






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


 










8.4.2.


Effects on non-target soil mesofauna (other than earthworms)






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


 










8.4.2.1.


Species level testing – collembola






OECD Test Guideline 232: Collembolan Reproduction Test in Soil


 










8.4.2.1.


Species level testing – predatory mites






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


 










8.5.


Effects on soil nitrogen transformation






OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test


 










8.6.


Effects on terrestrial non-target higher plants






—


 










8.6.1.


Summary of screening data






—


 










8.6.2.


Testing on non-target plants – seedling emergence and seedling growth






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


 










8.6.2.


Testing on non-target plants – terrestrial plant vegetative vigor testing






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


 










8.7.


Effects on other terrestrial organisms (flora and fauna)






—


 










8.8.


Effects on biological methods for sewage treatment






OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test


 










9.


LITERATURE DATA






 


 










10.


CLASSIFICATION AND LABELLING