Communication from the Commission in the framework of the implementation of Part A of the Annex of the Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products, 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 344/01
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.01000101.xml










29.9.2023   


EN


Official Journal of the European Union


C 344/1







Communication from the Commission in the framework of the implementation of Part A of the Annex of the Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products, 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 344/01)


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 284/2013 (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, CIPAC) 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 guidance documents and test methods are listed.

Test methods

Where Commission Regulation (EC) No 440/2008 (3) provides for cross-reference to an OECD test method (by indicating that a test method is replicated, analogous to or equivalent to an OECD test method) in most cases only the OECD 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 can consider whether new tests 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 284/2013, 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 284/2013.
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 will prioritise 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 284/2013;










—


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, 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 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, 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. 85).

(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); 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 according to Regulation (EU) No 284/2013







Reference to Part A of the Annex to Regulation (EU) No 284/2013


Guidance documents


Notes





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


 





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



Commission Notice of 10 October 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



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


 





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



ECHA Guidance on the Application of the CLP Criteria


 





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 for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA). Series on Testing and Assessment, 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 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 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)


 





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 PLANT PROTECTION PRODUCT






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


 










1.


IDENTITY OF THE PLANT PROTECTION PRODUCT






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 PLANT PROTECTION PRODUCT






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


 










2.


PHYSICAL AND CHEMICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT






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)


 










2.


PHYSICAL AND CHEMICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT






ECHA Guidance on the Application of the CLP Criteria


 










2.1.


Appearance






—


 










2.2.


Explosive and oxidising properties






—


 










2.3.


Flammability and self-heating






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


 










2.4.


Acidity/alkalinity and pH value






—


 










2.5.


Viscosity and surface tension






—


 










2.6.


Relative density and bulk density






—


 










2.7.


Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection product






—


 










2.8.


Technical characteristics of the plant protection product






—


 










2.8.1.


Wettability






—


 










2.8.2.


Persistent foaming






—


 










2.8.3.


Suspensibility, spontaneity of dispersion and dispersion stability






—


 










2.8.4.


Degree of dissolution and dilution stability






—


 










2.8.5.


Particle size distribution, dust content, attrition and mechanical stability






—


 










2.8.5.1.


Particle size distribution






—


 










2.8.5.2.


Dust content






—


 










2.8.5.3.


Attrition






—


 










2.8.5.4.


Hardness and integrity






—


 










2.8.6.


Emulsifiability, re-emulsifiability, emulsion stability






—


 










2.8.7.


Flowability, pourability and dustability






—


 










2.9.


Physical compatibility with other products including plant protection products with which its use is to be authorized






—


 










2.10.


Adherence and distribution to seeds






—


 










2.11.


Other studies






—


 










3.


DATA ON APPLICATION







—



 










4.


FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT






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


 










4.


FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT






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)


 










5.


ANALYTICAL METHODS






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


 










5.1.


Methods used for the generation of pre-authorisation data






 


 










5.1.1.


Methods for the analysis of the plant protection product






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)


 










5.1.2.


Methods for the determination of residues






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


 










5.1.2.


Methods for the determination of residues






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


 










5.1.2.


Methods for the determination of residues






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


 










5.2.


Methods for post-authorisation control and monitoring purposes






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


 










5.2.


Methods for post-authorisation control and monitoring purposes






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


 










5.2.


Methods for post-authorisation 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


 










6.


EFFICACY DATA






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)


 










6.


EFFICACY DATA






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)


 










6.


EFFICACY DATA






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.










6.1.


Preliminary tests






—


 










6.2.


Testing effectiveness






—


 










6.3.


Information on the occurrence or possible occurrence of the development of resistance






—


 










6.4.


Adverse effects on treated crops






—


 










6.4.1.


Phytotoxicity to target plants (including different cultivars), or to target plant products






—


 










6.4.2.


Effects on the yield of treated plants or plant products






—


 










6.4.3.


Effects on the quality of plants or plant product






—


 










6.4.4.


Effects on transformation processes






—


 










6.4.5.


Impact on treated plants or plant products to be used for propagation






—


 










6.5.


Observations on other undesirable or unintended side-effects






—


 










6.5.1.


Impact on succeeding crops






—


 










6.5.2.


Impact on other plants, including adjacent crops






—


 










6.5.3.


Effects on beneficial and other non-target organisms






—


 










7.


TOXICOLOGICAL STUDIES






—


 










7.1.


Acute toxicity






—


 










7.1.1.


Oral toxicity






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


 










7.1.1.


Oral toxicity






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


 










7.1.2.


Dermal toxicity






—


 










7.1.3.


Inhalation toxicity






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


 










7.1.3.


Inhalation toxicity






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


 










7.1.4.


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


 










7.1.5.


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


 










7.1.5.


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 & Assessment, No 160


 










7.1.6.


Skin sensitisation






—


 










7.1.7.


Supplementary studies on the plant protection product






—


 










7.1.8.


Supplementary studies for combinations of plant protection products






—


 










7.2.


Data on exposure






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)


 










7.2.1.


Operator exposure






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


 










7.2.1.1.


Estimation of operator exposure






—


 










7.2.1.2.


Measurement of operator exposure






—


 










7.2.2.


Bystander and resident exposure






—


 










7.2.2.1.


Estimation of bystander and resident exposure






—


 










7.2.2.2.


Measurement of bystander and resident exposure






—


 










7.2.3.


Worker exposure






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


 










7.2.3.1.


Estimation of worker exposure






—


 










7.2.3.2.


Measurement of worker exposure






—


 










7.3.


Dermal absorption






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


 










7.4.


Available toxicological data relating to co-formulants






—


 










8.


RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED






Guidance documents reported in Section 6 of Annex I to Commission Communication C(2023) 6245 apply


 










9.


FATE AND BEHAVIOUR IN THE ENVIRONMENT






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)


 










9.1.


Fate and behaviour 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.










9.1.1.


Rate of degradation in soil






—


 










9.1.1.1.


Laboratory studies






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


 










9.1.1.2.


Field studies






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


 










9.1.2.


Mobility in the soil






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)


 










9.1.2.1.


Laboratory studies






Guidance documents reported in Section 7.1.2 and 7.1.3.1 of Annex I to Communication C(2023) 6245 apply


According to Section 9.1.2.1 of Part A of the Annex to
Regulation (EU) No 284/2013, the same provisions as provided under points 7.1.2 and 7.1.3.1 of Part A of the Annex to Regulation (EU) No 283/2013 apply.










9.1.2.2.


Lysimeter studies






—


 










9.1.2.3.


Field leaching studies






—


 










9.1.3.


Estimation of concentrations in soil – Guidance on PEC calculation






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


 










9.1.3.


Estimation of concentrations in soil – Guidance on PEC calculation






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)


 










9.2.


Fate and behaviour in water and sediment







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.










9.2.1.


Aerobic mineralisation in surface water






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


 










9.2.2.


Water/sediment study







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))


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










9.2.2.


Water/sediment study






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


 










9.2.3.


Irradiated water/sediment study






—


 










9.2.4.


Estimation of concentrations in groundwater







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.










9.2.4.


Estimation of concentrations in groundwater






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)


 










9.2.4.


Estimation of concentrations in groundwater






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)


 










9.2.4.


Estimation of concentrations in groundwater






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)


 










9.2.4.1.


Calculation of concentrations in groundwater






—


 










9.2.4.2.


Additional field tests






—


 










9.2.5.


Estimation of concentrations in surface water and sediment.







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))


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










9.2.5.


Estimation of concentrations in surface water and sediment






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


 










9.3.


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)


 










9.4.


Estimation of concentrations for other routes of exposure






—


 










10.


ECOTOXICOLOGICAL STUDIES






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


 










10.1.


Effects on birds and other terrestrial vertebrates






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


 










10.1.1.


Effects on birds






—


 










10.1.1.1.


Acute oral toxicity to birds






—


 










10.1.1.2.


Higher tier data on birds






—


 










10.1.2.


Effects on terrestrial vertebrates other than birds






—


 










10.1.2.1.


Acute oral toxicity to mammals






—


 










10.1.2.2.


Higher tier data on mammals






—


 










10.1.3.


Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)






—


 










10.2.


Effects 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)


 










10.2.


Effects on aquatic organisms






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)


 










10.2.1.


Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes






Guidance documents reported in point 8.2 of Annex I to Communication C(2023) 6245 apply


According to Section 10.2.1 of Part A of the Annex to Regulation (EU) No 284/2013, tests must be carried out on one species from each of the three/four groups of aquatic organisms, that is to say fish, aquatic invertebrates, algae and, where relevant, macrophytes as referred to in point 8.2 of Part A of the Annex to Regulation (EU) No 283/2013, if the plant protection product itself may contaminate water.










10.2.2.


Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms






Guidance documents reported in point 8.2.2 and 8.2.5 of Annex I to Communication C(2023) 6245 apply


According to Section 10.2.2 of Part A of the Annex to Regulation (EU) No 284/2013, the studies referred to in points 8.2.2 and 8.2.5 of Part A of the Annex to Regulation (EU) No 283/2013 must be conducted for particular plant protection products, where it is not possible to extra polate from data obtained in the corresponding studies on the active substance (for example the plant protection product is more acutely toxic than the active substance as manufactured by a factor of 10), unless it is demonstrated that exposure will not occur.










10.2.3.


Further testing on aquatic organisms






—


 










10.3.


Effects on arthropods






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


 










10.3.1.


Effects on bees






—


 










10.3.1.1.


Acute toxicity to bees






—


 










10.3.1.1.1.


Acute oral toxicity






—


 










10.3.1.1.2.


Acute contact toxicity






—


 










10.3.1.2.


Chronic toxicity to bees






—


 










10.3.1.3.


Effects on honey bee development and other honey bee life stages






 


 










10.3.1.4.


Sub-lethal effects






 


 










10.3.1.5.


Cage and tunnel tests






—


 










10.3.1.6.


Field tests with honeybees






—


 










10.3.2.


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


 










10.3.2.


Effects on non-target arthropods other than bees






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


 










10.3.2.1.


Standard laboratory testing for non-target arthropods






—


 










10.3.2.2.


Extended laboratory testing, aged residue studies with non-target arthropods






—


 










10.3.2.3.


Semi-field studies with non-target arthropods






—


 










10.3.2.4.


Field studies with non-target arthropods






—


 










10.3.2.5.


Other routes of exposure for non-target arthropods






—


 










10.4.


Effects on non-target soil meso- and macrofauna






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


 










10.4.1.


Earthworms






 


 










10.4.1.1.


Earthworms – sub-lethal effects






—


 










10.4.1.2.


Earthworms – field studies






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


 










10.4.2.


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






—


 










10.4.2.1.


Species level testing






—


 










10.4.2.2.


Higher tier testing






—


 










10.5.


Effects on soil nitrogen transformation






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


 










10.6.


Effects on terrestrial non-target higher plants






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


 










10.6.1.


Summary of screening data






—


 










10.6.2.


Testing on non-target plants






—


 










10.6.3.


Extended laboratory studies on non-target plants






—


 










10.6.4.


Semi-field and field tests on non-target plants






—


 










10.7.


Effects on other terrestrial organisms (flora and fauna)






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


 










10.8.


Monitoring data






—


 










11.


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)


 










11.


LITERATURE DATA






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


 










12.


CLASSIFICATION AND LABELLING






ECHA Guidance on the Application of the CLP Criteria


 









ANNEX II
Test methods recommended according to Regulation (EU) No 284/2013







Reference to Part A of the Annex to Regulation (EU) No 284/2013


Test methods


Notes





Guidance for certain classes of substances



—


 










1.


IDENTITY OF THE PLANT PROTECTION PRODUCT






 


 










2.


PHYSICAL AND CHEMICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT






 


 










2.1.


Appearance






—


 










2.2.


Explosive and oxidising properties – Explosive properties






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


 










2.2.


Explosive and oxidising properties – Explosive properties






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


 










2.2.


Explosive and oxidising properties – Oxidising properties






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


 










2.2.


Explosive and oxidising properties – Oxidising properties






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


 










2.2.


Explosive and oxidising properties – Oxidising properties






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


 










2.2.


Explosive and oxidising properties – Oxidising properties






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


 










2.2.


Explosive and oxidising properties – Oxidising properties






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


For solid preparations










2.2.


Explosive and oxidising properties – Oxidising properties






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


 










2.3.


Flammability and self-heating – Flammability






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


 










2.3.


Flammability and self-heating – Flammability






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


 










2.3.


Flammability and self-heating – Flammability






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


 










2.3.


Flammability and self-heating – Flammability






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


 










2.3.


Flammability and self-heating – Flammability






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


 










2.3.


Flammability and self-heating – Flammability






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


 










2.3.


Flammability and self-heating – Flammability






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


 










2.3.


Flammability and self-heating – Flammability






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


 










2.3.


Flammability and self-heating – Self-heating






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


 










2.3.


Flammability and self-heating – Self-heating






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


 










2.3.


Flammability and self-heating – Self-heating






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


 










2.3.


Flammability and self-heating – Self-heating






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


 










2.4.


Acidity/alkalinity and pH value






CIPAC Method MT 75: Determination of pH values


 










2.4.


Acidity/alkalinity and pH value






CIPAC Method MT 31: Free acidity or alkalinity


 










2.4.


Acidity/alkalinity and pH value






CIPAC Method MT 191: Acidity or alkalinity of formulations


 










2.4.


Acidity/alkalinity and pH value






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


 










2.4.


Acidity/alkalinity and pH value






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


 










2.5.


Viscosity and surface tension – viscosity






OECD Test Guideline 114: Viscosity of Liquids


Applicable for newtonian or non-newtonian liquids










2.5.


Viscosity and surface tension – viscosity






CIPAC method MT 192: Viscosity of liquids by rotational viscosimetry


Applicable for newtonian or non-newtonian liquids










2.5.


Viscosity and surface tension






OECD Test Guideline 115: Surface Tension of Aqueous Solutions


 










2.5.


Viscosity and surface tension






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


 










2.6.


Relative density and bulk density – relative density






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


 










2.6.


Relative density and bulk density – relative density






OECD Test Guideline 109 – Density of Liquids and Solids


 










2.6.


Relative density and bulk density – bulk density






CIPAC Method MT 186: Bulk density


 










2.7.


Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection product – stability






CIPAC Method MT 46: Accelerated storage procedure


 










2.7.


Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection product – effects of low temperatures on liquid preparations






CIPAC Method MT 39: Low temperature stability of liquid formulations


 










2.8.


Technical characteristics of the plant protection product






—


 










2.8.1.


Wettability






CIPAC Method MT 53: Wettability, wetting of wettable powders


 










2.8.2.


Persistent foaming






CIPAC Method MT 47: Persistent foam


 










2.8.3.


Suspensibility, spontaneity of dispersion and dispersion stability – suspensibility






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


 










2.8.3.


Suspensibility, spontaneity of dispersion and dispersion stability – spontaneity of dispersion






CIPAC Method MT 160: Spontaneity of dispersion of suspension concentrates


 










2.8.3.


Suspensibility, spontaneity of dispersion and dispersion stability – spontaneity of dispersion






CIPAC Method MT 174: Dispersibility of water dispersible granules


 










2.8.3.


Suspensibility, spontaneity of dispersion and dispersion stability – dispersion stability






CIPAC Method MT 180: Dispersion stability of suspo-emulsion


 










2.8.4.


Degree of dissolution and dilution stability






CIPAC Method MT 41: Dilution stability of aqueous solutions


 










2.8.4.


Degree of dissolution and dilution stability






CIPAC Method MT 179: Degree of Dissolution and Solution Stability


 










2.8.4.


Degree of dissolution and dilution stability






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


 










2.8.5.


Particle size distribution, dust content, attrition and mechanical stability






—


 










2.8.5.1.


Particle size distribution






CIPAC Method MT 185: Wet sieve test


Applicable for water dispersible products










2.8.5.1.


Particle size distribution






CIPAC Method MT 187: Particle size analysis by laser diffraction


Applicable for powders and granules










2.8.5.1.


Particle size distribution






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


Applicable for granules










2.8.5.2.


Dust content






CIPAC Method MT 171: Dustiness of granular products


 










2.8.5.3.


Attrition






CIPAC Method MT 178: Attrition resistance of granules


 










2.8.5.3.


Attrition






CIPAC Method MT 193: Attrition of tablets


 










2.8.5.4.


Hardness and integrity






CIPAC Method MT 197: Disintegration of tablets


 










2.8.6.


Emulsifiability, re-emulsifiability, emulsion stability






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


 










2.8.7.


Flowability, pourability and dustability – flowability






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


 










2.8.7.


Flowability, pourability and dustability – pourability






CIPAC Method MT 148: Pourability of suspension concentrates


 










2.9.


Physical compatibility with other products including plant protection products with which its use is to be authorized






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


 










2.10.


Adherence and distribution to seeds – distribution






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


 










2.10.


Adherence and distribution to seeds – adhesion






CIPAC Method MT 194: Adhesion to Treated Seed


 










2.10.


Adherence and distribution to seeds – adhesion






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.


 










2.11.


Other studies






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


 










2.11.


Other studies






CIPAC Method MT 176: Dissolution rate of water soluble bags


 










2.11.


Other studies






CIPAC Method MT 23: Miscibility with hydrocarbon oil


 










3.


DATA ON APPLICATION






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


 










3.


DATA ON APPLICATION






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


 










3.


DATA ON APPLICATION






EPPO Standard PP1/248: Harmonized system for classification and coding of the uses 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.


DATA ON APPLICATION






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


 










3.


DATA ON APPLICATION






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


 










3.


DATA ON APPLICATION






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


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










4.


FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT






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


 










5.


ANALYTICAL METHODS







—



 










6.


EFFICACY DATA






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


 










6.1.


Preliminary tests






—


 










6.2.


Testing effectiveness






—


 










6.3.


Information on the occurrence or possible occurrence of the development of resistance






—


 










6.4.


Adverse effects on treated crops






—


 










6.4.1.


Phytotoxicity to target plants (including different cultivars), or to target plant products






—


 










6.4.2.


Effects on the yield of treated plants or plant products






—


 










6.4.3.


Effects on the quality of plants or plant product






—


 










6.4.4.


Effects on transformation processes






—


 










6.4.5.


Impact on treated plants or plant products to be used for propagation






ISTA Methods


For seeds harvested from treated plants










6.5.


Observations on other undesirable or unintended side-effects






—


 










6.5.1.


Impact on succeeding crops






—


 










6.5.2.


Impact on other plants, including adjacent crops






—


 










6.5.3.


Effects on beneficial and other non-target organisms






—


 










7.


TOXICOLOGICAL STUDIES






—


 










7.1.


Acute toxicity






—


 










7.1.1.


Oral toxicity






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


 










7.1.1.


Oral toxicity






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


 










7.1.1.


Oral toxicity






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


 










7.1.1.


Oral toxicity






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


 










7.1.2.


Dermal toxicity






OECD Test Guideline 402: Acute Dermal Toxicity


 










7.1.3.


Inhalation toxicity






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


 










7.1.3.


Inhalation toxicity






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


 










7.1.3.


Inhalation toxicity






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.










7.1.4.


Skin irritation






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


 










7.1.4.


Skin irritation






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


 










7.1.4.


Skin irritation






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


 










7.1.4.


Skin irritation






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


 










7.1.4.


Skin irritation






OECD Test Guideline 404: Acute Dermal Irritation/Corrosion


 










7.1.5.


Eye irritation






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


 










7.1.5.


Eye irritation






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


 










7.1.5.


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


 










7.1.5.


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


 










7.1.5.


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


 










7.1.5.


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


 










7.1.5.


Eye irritation






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


 










7.1.5.


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


 










7.1.5.


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


 










7.1.5.


Eye irritation






OECD Test Guideline 405: Acute eye irritation/corrosion


 










7.1.6.


Skin sensitisation






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


 










7.1.6.


Skin sensitisation






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


 










7.1.6.


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










7.1.6.


Skin sensitisation






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


 










7.1.7.


Supplementary studies on the plant protection product






—


 










7.1.8.


Supplementary studies for combinations of plant protection products






—


 










7.2.


Data on exposure






—


 










7.2.1.


Operator exposure






—


 










7.2.1.1.


Estimation of operator exposure






—


 










7.2.1.2.


Measurement of operator exposure






—


 










7.2.2.


Bystander and resident exposure






—


 










7.2.2.1.


Estimation of bystander and resident exposure






—


 










7.2.2.2.


Measurement of bystander and resident exposure






—


 










7.2.3.


Worker exposure






—


 










7.2.3.1.


Estimation of worker exposure






—


 










7.2.3.2.


Measurement of worker exposure






—


 










7.3.


Dermal absorption






OECD Test Guideline 428: Skin absorption: in vitro method


 










7.3.


Dermal absorption






OECD Test Guideline 427: Skin absorption: in vivo method


 










7.4.


Available toxicological data relating to co-formulants






—


 










8.


RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED






Where relevant, same test methods as reported in Section 6 of the Annex II to Communication C(2023) 6245 apply


According to Section 8 of Part A of the Annex to Regulation (EU) No 284/2013, data and information on residues in or on treated products, food and feed in accordance with Section 6 of Part A of the Annex to Regulation (EU) No 283/2013 must be submitted, unless the applicant shows that the data and information already submitted for the active substance can be applied.










9.


FATE AND BEHAVIOUR IN THE ENVIRONMENT






—


 










9.1.


Fate and behaviour in soil






OECD Test Guideline 307: Aerobic and anaerobic transformation in soil


 










9.1.


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










9.1.


Fate and behaviour in soil






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


 










9.1.1.


Rate of degradation in soil






—


 










9.1.1.1.


Laboratory studies






OECD Test Guideline 307: Aerobic and anaerobic transformation in soil


 










9.1.1.2.


Field studies






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


 










9.1.2.


Mobility in the soil






—


 










9.1.2.1.


Laboratory studies






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


 










9.1.2.1.


Laboratory studies






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


 










9.1.2.1.


Laboratory studies






OECD Test Guideline 312: Leaching in Soil Columns


 










9.1.2.1.


Laboratory studies






OECD Test Guideline 307: Aerobic and anaerobic transformation in soil


 










9.1.2.2.


Lysimeter studies






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


 










9.1.2.3.


Field leaching studies






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


 










9.1.3.


Estimation of concentrations in soil






—


 










9.2.


Fate and behaviour in water and sediment






—


 










9.2.1.


Aerobic mineralisation in surface water






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


 










9.2.2.


Water/sediment study






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


 










9.2.3.


Irradiated water/sediment study






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


 










9.2.4.


Estimation of concentrations in groundwater






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)


 










9.2.4.1.


Calculation of concentrations in groundwater






—


 










9.2.4.2.


Additional field tests






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


 










9.2.5.


Estimation of concentrations in surface water and sediment.






—


 










9.3.


Fate and behaviour in air






—


 










9.3.1.


Route and rate of degradation in air and transport via air






—


 










9.4.


Estimation of concentrations for other routes of exposure






—


 










10.


ECOTOXICOLOGICAL STUDIES






—


 










10.1.


Effects on birds and other terrestrial vertebrates






—


 










10.1.1.


Effects on birds






—


 










10.1.1.1.


Acute oral toxicity to birds






OECD Test Guideline 223: Avian Acute oral toxicity study


 










10.1.1.1.


Acute oral toxicity to birds






US EPA OCSPP 850.2100: Avian Acute Oral Toxicity Test


 










10.1.1.2.


Higher tier data on birds






—


 










10.1.2.


Effects on terrestrial vertebrates other than birds






—


 










10.1.2.1.


Acute oral toxicity to mammals






Please refer to 7.1.1


 










10.1.2.2.


Higher tier data on mammals






—


 










10.1.3.


Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)






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


 










10.1.3.


Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)






OECD Test Guideline 231: Amphibian Metamorphosis Assay


 










10.1. 3.


Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)






OECD Test Guideline 241: Larval Amphibian Growth and Development Test


 










10.2.


Effects on aquatic organisms






—


 










10.2.1.


Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes – fish






Where relevant, same test methods as reported in Section 8.2 of the Annex II to Communication C(2023) 6245 apply


According to Section 10.2.1 of Part A of the Annex to Regulation (EU) No 284/2013, tests shall be carried out on one species from each of the three/four groups of aquatic organisms, that is to say fish, aquatic invertebrates, algae and, where relevant, macrophytes as referred to in point 8.2 of Part A of the Annex to Regulation (EU) No 283/2013, if the plant protection product itself may contaminate water.










10.2.2.


Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms – fish






Where relevant, same test methods as reported in points 8.2.2 and 8.2.5 of the Annex II to Communication C(2023) 6245 apply


According to section 10.2.2 Part A of the Annex to Regulation (EU) No 284/2013, the studies referred to in points 8.2.2 and 8.2.5 of Part A of the Annex to Regulation (EU) No 283/2013 must be conducted for particular plant protection products, where it is not possible to extra polate from data obtained in the corresponding studies on the active substance (for example the plant protection product is more acutely toxic than the active substance as manufactured by a factor of 10), unless it is demonstrated that exposure will not occur.










10.2.3.


Further testing on aquatic organisms






—


 










10.3.


Effects on arthropods






—


 










10.3.1.


Effects on bees






—


 










10.3.1.1.


Acute toxicity to bees






—


 










10.3.1.1.1.


Acute oral toxicity






EPPO 170(4) Side-effects on honeybees


 










10.3.1.1.1.


Acute oral toxicity






OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test


 










10.3.1.1.1.


Acute oral toxicity






OECD Test Guideline 247: Bumblebee, Acute Oral Toxicity Test


 










10.3.1.1.2.


Acute contact toxicity






EPPO 170(4) Side-effects on honeybees


 










10.3.1.1.2.


Acute contact toxicity






OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test


 










10.3.1.1.2.


Acute contact toxicity






OECD Test Guideline 246: Bumblebee, Acute Contact Toxicity Test


 










10.3.1.2.


Chronic toxicity to bees






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


 










10.3.1.3.


Effects on honey bee development and other honey bee life stages






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


 










10.3.1.3.


Effects on honey bee development and other honey bee life stages






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


 










10.3.1.3.


Effects on honey bee development and other honey bee life stages






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


 










10.3.1.3.


Effects on honey bee development and other honey bee 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


 










10.3.1.3.


Effects on honey bee development and other honey bee 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


 










10.3.1.4.


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


 










10.3.1.5.


Cage and tunnel tests






EPPO 170(4) Side-effects on honeybees


 










10.3.1.5.


Cage and tunnel tests






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


 










10.3.1.6.


Field tests with honeybees






EPPO 170(4) Side-effects on honeybees


 










10.3.1.6.


Field tests with 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


 










10.3.1.6.


Field tests with honeybees






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


 










10.3.2.


Effects on non-target arthropods other than bees






—


 










10.3.2.1.


Standard laboratory testing for non-target arthropods






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)


 










10.3.2.2.


Extended laboratory testing, aged residue studies with non-target arthropods






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)


 










10.3.2.2.


Extended laboratory testing, aged residue studies with non-target arthropods






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)


 










10.3.2.3.


Semi-field studies with non-target arthropods






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)


 










10.3.2.4.


Field studies with non-target arthropods






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)


 










10.3.2.5.


Other routes of exposure for non-target arthropods






—


 










10.4.


Effects on non-target soil meso- and macrofauna






—


 










10.4.1.


Earthworms






—


 










10.4.1.1.


Earthworms – sub-lethal effects






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


 










10.4.1.2.


Earthworms – field studies






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


 










10.4.1.2.


Earthworms – field studies






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


 










10.4.2.


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)


 










10.4.2.1.


Species level testing – collembola






OECD Test Guideline 232: Collembolan Reproduction Test in Soil


 










10.4.2.1.


Species level testing – predatory mites






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


 










10.4.2.2.


Higher tier testing






—


 










10.5.


Effects on soil nitrogen transformation






OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test


 










10.6.


Effects on terrestrial non-target higher plants






—


 










10.6.1.


Summary of screening data






—


 










10.6.2.


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






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


 










10.6.2.


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






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


 










10.6.3.


Extended laboratory studies on non-target plants






—


 










10.6.4.


Semi-field and field tests on non-target plants






—


 










10.7.


Effects on other terrestrial organisms (flora and fauna)






—


 










10.8.


Monitoring data






—


 










11.


LITERATURE DATA






—


 










12.


CLASSIFICATION AND LABELLING