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Document 52023XC0929(01)
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
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
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
C/2023/6285
OJ C 344, 29.9.2023, p. 1–36
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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:
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have been endorsed by the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) before the publication of this Communication, |
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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 |
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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:
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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; |
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Administrative/procedural guidance documents if they are relevant for the implementation of the data requirements; |
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Models or calculation tools, if they are relevant for the data requirements and can be linked to or are supportive to a guidance document; |
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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 |
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General guidance |
EFSA Guidance on Uncertainty Analysis in Scientific Assessments (EFSA Journal 2018;16(1):5123) |
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General guidance |
EFSA Guidance on the assessment of the biological relevance of data in scientific assessments (EFSA Journal 2017;15(8):4970) |
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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) |
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General guidance |
OECD Guidance Document for Describing Non-Guideline In-vitro Test Methods, Series on Testing and Assessment, No 211 |
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General guidance |
Guidance document for environmental risk assessments of active substances used on rice in the EU for Annex 1 inclusion (SANCO/1090/2000) |
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General guidance |
Guidance document on botanical active substances used in plant protection products (SANCO/11470/2012) |
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General guidance |
Guidance document on semiochemical active substances used and plant protection products (SANTE/12815/2014) |
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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) |
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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 |
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General guidance |
OECD Consideration for assessing the risk of combined exposure to multiple chemicals. Series on Testing and Assessment, No 296 |
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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) |
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General guidance |
ECHA Guidance on the Application of the CLP Criteria |
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General guidance |
OECD Guidance Documents on the Validation of (Quantitative) Structure-Activity Relationship [(Q)SAR] Models. Series on Testing and Assessment No 69 |
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General guidance |
ECHA Practical Guide – how to use and report (Q)SARs |
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General guidance |
OECD Guidance on Grouping of Chemicals, Second Edition. Series on Testing and Assessment, No 194 |
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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 |
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General guidance |
OECD Guidance Document on Developing and Assessing Adverse Outcome Pathways. Series on Testing and Assessment No 184 |
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General guidance |
OECD Guidance Document on Good In Vitro Method Practices (GIVIMP) |
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General guidance |
OECD Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests Series on Testing & Assessment No 237 |
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General guidance |
EFSA Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Journal 2019;17(6):5708) |
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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) |
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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) |
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General guidance |
ECHA. Read-Across Assessment Framework (RAAF), ECHA-17-R-01-EN |
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WHO/FAO Pesticide Specifications. Manual on development and use of FAO and WHO specifications for chemical pesticides |
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EU Guidance Document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No 1107/2009 (SANCO/10597/2003) |
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WHO/FAO Pesticide Specifications. Manual on development and use of FAO and WHO specifications for chemical pesticides |
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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) |
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ECHA Guidance on the Application of the CLP Criteria |
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OECD Guidance Document for flammability testing of plant protection and biocidal products Series on Testing and Assessment, No 330 |
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FAO Guidelines for the packaging and storage of pesticides (FAO, Rome, 1985) |
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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) |
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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 |
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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) |
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Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE/2017/10632) |
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Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830) |
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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 |
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Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE/2017/10632) |
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Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830) |
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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 |
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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) |
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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) |
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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. |
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OECD Guidance document on acute oral toxicity testing. OECD Series on Testing and Assessment, No 24 |
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OECD Guidance Document on using Cytotoxicity Tests to Estimate Starting Doses for Acute Oral Systemic Toxicity Tests. Series on Testing and Assessment, No 129 |
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OECD Guidance Document for the Derivation of an Acute Reference Concentration (Arfc). Series on Testing and Assessment, No 153 |
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OECD Guidance Document on inhalation toxicity studies. Series on Testing and Assessment No 39 |
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OECD Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation, Series on Testing and Assessment, No 203 |
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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 |
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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 |
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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) |
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OECD Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application. Series on Testing and Assessment No 9 |
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OECD Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application. Series on Testing and Assessment No 9 |
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EFSA Guidance on dermal absorption (SANTE/2018/10591) |
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Guidance documents reported in Section 6 of Annex I to Commission Communication C(2023) 6245 apply |
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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) |
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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. |
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DG SANCO Working Document on ‘Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides’ |
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OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides No 82. Series on Testing and Assessment, No 232 |
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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) |
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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. |
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Soil persistence models and EU registration, final report of the FOCUS Soil modelling workgroup (SANCO/7617/VI/96) |
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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) |
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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. |
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DG SANCO Working Document on ‘Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides’ |
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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. |
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DG SANCO Working Document on ‘Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides’ |
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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. |
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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) |
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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) |
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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) |
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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. |
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‘Pesticides in Air: Considerations for Exposure Assessment’. Report of the FOCUS Working Group on Pesticides in Air (SANCO/10553/2006) |
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‘Pesticides in Air: Considerations for Exposure Assessment’. Report of the FOCUS Working Group on Pesticides in Air (SANCO/10553/2006) |
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OECD Current approaches in the statistical analysis of ecotoxicity data: a guidance to application. Series of testing and assessment, No 54 |
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EFSA Risk assessment for birds and mammals (EFSA Journal 2009; 7(12):1438) |
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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) |
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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) |
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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. |
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|
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. |
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— |
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EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) |
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— |
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— |
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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 |
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De Jong et al. (2010) Guidance for summarising and evaluating field studies with non-target arthropods |
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— |
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— |
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— |
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— |
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— |
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EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) |
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— |
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De Jong et al. (2006): Guidance for summarizing earthworm field studies. RIVM report No 601506006/2006 |
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— |
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— |
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— |
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|
EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) |
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|
EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) |
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— |
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— |
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— |
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— |
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EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) |
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— |
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|
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) |
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EFSA Application of systematic review methodology to food and feed safety assessments to support decision making (EFSA Journal 2010;8(6):1637) |
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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 |
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Guidance for certain classes of substances |
— |
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— |
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Test methods according to Test series 1-3, Part I of the UN RTDG Manual of Tests and Criteria |
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Method A.14: Explosive properties (Annex of Regulation (EC) No 440/2008) |
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Test method according to Section 2.4.4 of Part 2 of Annex I to Regulation (EC) No 1272/2008 |
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Test O.2: Test for oxidizing liquids, Part III of UN RTDG Manual of Tests and Criteria |
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Test O.1: Test for oxidizing solids, Part III of UN RTDG Manual of Tests and Criteria |
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Test O.3: Gravimetric test for oxidising solids, Part III of UN RTDG Manual of Tests and Criteria |
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Method A.17: Oxidising properties (solids) (Annex of Regulation (EC) No 440/2008) |
For solid preparations |
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Method A.21: Oxidising properties (liquids) (Annex of Regulation (EC) No 440/2008) |
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Method A.9: Flash-point (liquids) (Annex of Regulation (EC) No 440/2008) |
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Test methods according to table 2.6.3 of Annex I, Part 2, of Regulation (EC) No 1272/2008 (liquids) |
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Test N.1: Test method for flammable solids, Part III of UN RTDG Manual of Tests and Criteria (solids) |
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Method A.10: Flammability (Annex of Regulation (EC) No 440/2008) for solids (solids) |
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Method A.11: Flammability (Annex of Regulation (EC) No 440/2008) for gaseous materials (gaseous materials) |
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Method A.12 (Annex of Regulation (EC) No 440/2008) for contact with water (solids and liquids) |
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Test methods according to Section 2.2.4.1 of Annex I, Part 2, of Regulation (EC) No 1272/2008 |
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Test L.2: sustained combustibility test, Part III of the UN RTDG Manual of Tests and Criteria |
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Method A.15 (Annex of Regulation (EC) No 440/2008) for liquids and Gases (liquids and gases) |
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Method A.16 (Annex of Regulation (EC) No 440/2008) for solids (solids) |
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Test N.4: Test method for self-heating substances, Part III of UN RTDG Manual of Tests and Criteria |
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||
|
ISO/IEC 80079-20-1:2017 – Explosive atmospheres – Part 20-1: Material characteristics for gas and vapour classification – Test methods and data |
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|
CIPAC Method MT 75: Determination of pH values |
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CIPAC Method MT 31: Free acidity or alkalinity |
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CIPAC Method MT 191: Acidity or alkalinity of formulations |
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|
Test methods according to Part III of the UN RTDG Manual of Tests and Criteria |
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|
OECD Test Guideline 122: Determination of pH, Acidity and Alkalinity |
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||
|
OECD Test Guideline 114: Viscosity of Liquids |
Applicable for newtonian or non-newtonian liquids |
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|
CIPAC method MT 192: Viscosity of liquids by rotational viscosimetry |
Applicable for newtonian or non-newtonian liquids |
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OECD Test Guideline 115: Surface Tension of Aqueous Solutions |
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Method A.5: Surface tension, (Annex of Regulation (EC) No 440/2008) |
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Method A.3: Relative density (Annex of Regulation (EC) No 440/2008) |
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OECD Test Guideline 109 – Density of Liquids and Solids |
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CIPAC Method MT 186: Bulk density |
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CIPAC Method MT 46: Accelerated storage procedure |
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CIPAC Method MT 39: Low temperature stability of liquid formulations |
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— |
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CIPAC Method MT 53: Wettability, wetting of wettable powders |
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CIPAC Method MT 47: Persistent foam |
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CIPAC Method MT 184: Suspensibility of formulations forming suspensions on dilution with water |
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CIPAC Method MT 160: Spontaneity of dispersion of suspension concentrates |
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CIPAC Method MT 174: Dispersibility of water dispersible granules |
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CIPAC Method MT 180: Dispersion stability of suspo-emulsion |
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CIPAC Method MT 41: Dilution stability of aqueous solutions |
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CIPAC Method MT 179: Degree of Dissolution and Solution Stability |
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CIPAC Method MT 196: Solution Properties of Water Soluble Tablets (ST) |
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— |
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|
CIPAC Method MT 185: Wet sieve test |
Applicable for water dispersible products |
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|
CIPAC Method MT 187: Particle size analysis by laser diffraction |
Applicable for powders and granules |
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|
CIPAC Method MT 170: Dry sieve analysis of water dispersible granules |
Applicable for granules |
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CIPAC Method MT 171: Dustiness of granular products |
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|
CIPAC Method MT 178: Attrition resistance of granules |
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|
CIPAC Method MT 193: Attrition of tablets |
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CIPAC Method MT 197: Disintegration of tablets |
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CIPAC Method MT 36: Emulsion characteristics and re-emulsification properties |
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|
CIPAC Method MT 172: Flowability of granular preparations after accelerated storage under pressure |
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|
CIPAC Method MT 148: Pourability of suspension concentrates |
|
||
|
ASTM E1518 – 05: Standard Practice for Evaluation of Physical Compatibility of Pesticides in Aqueous Tank Mixtures by the Dynamic Shaker Method |
|
||
|
CIPAC Method MT 175: Determination of seed-to-seed uniformity of distribution for liquid seed-treatment formulations |
|
||
|
CIPAC Method MT 194: Adhesion to Treated Seed |
|
||
|
European Seed Association, 2011. Assessment of free floating dust and abrasion particles of treated seeds as a parameter of the quality of treated seeds: Heubach test. ESA STAT Dust Working Group. |
|
||
|
Test methods reported in Annex I, Part II to Regulation (EC) No 1272/2008 |
|
||
|
CIPAC Method MT 176: Dissolution rate of water soluble bags |
|
||
|
CIPAC Method MT 23: Miscibility with hydrocarbon oil |
|
||
|
EPPO Standard PP1/239: Dose expression of plant protection products |
|
||
|
EPPO Standard PP1/240: Harmonized basic information for databases on plant protection products |
|
||
|
EPPO Standard PP1/248: Harmonized system for classification and coding of the uses of plant protection products |
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. |
||
|
EPPO Standard PP1/291: Evaluation of the influence of tank mix adjuvants on the efficacy of plant protection products |
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||
|
EPPO Standard PP1/306: General principles for the development of co-formulated mixtures of plant protection products |
|
||
|
EPPO Global Database on Crops and Pests (EPPO, 2017) |
Database available online: https://gd.eppo.int |
||
|
EPPO Standard PP1/292: Cleaning pesticide application equipment (PAE) – Efficacy aspects |
|
||
|
— |
|
||
|
EPPO standard series PP1 (Efficacy evaluation of plant protection products) |
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||
|
— |
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— |
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— |
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— |
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— |
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— |
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— |
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|
— |
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||
|
ISTA Methods |
For seeds harvested from treated plants |
||
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— |
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— |
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— |
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— |
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||
|
— |
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|
— |
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||
|
OECD Test Guideline 420: Acute oral toxicity: fixed dose procedure |
|
||
|
OECD Test Guideline 423: Acute oral toxicity: acute toxic class method |
|
||
|
OECD Test Guideline 425: Acute oral toxicity: up-and-down procedure |
|
||
|
OECD Test Guideline 401: Acute oral toxicity (only acceptable, if performed before December 2002) |
|
||
|
OECD Test Guideline 402: Acute Dermal Toxicity |
|
||
|
OECD Test Guideline 433: Acute Inhalation Toxicity: Fixed Concentration Procedure |
|
||
|
OECD Test Guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method |
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||
|
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. |
||
|
OECD Test Guideline 431: In vitro Skin Corrosion: reconstructed human epidermis (RHE) test method |
|
||
|
OECD Test Guideline 435: In vitro Membrane Barrier Test Method for Skin Corrosion |
|
||
|
OECD Test Guideline 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method |
|
||
|
OECD Test Guideline 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) |
|
||
|
OECD Test Guideline 404: Acute Dermal Irritation/Corrosion |
|
||
|
OECD Test Guideline 492B: Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification |
|
||
|
OECD Test Guideline 467: Defined Approaches for Serious Eye Damage and Eye Irritation |
|
||
|
OECD Test Guideline 496: In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage |
|
||
|
OECD Test No. 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage |
|
||
|
OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying (i) Chemicals Inducing Serious Eye Damage and (ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage |
|
||
|
OECD Test Guideline 438: Isolated Chicken Eye Test Method for Identifying (i) Chemicals Inducing Serious Eye Damage and (ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage |
|
||
|
OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants |
|
||
|
OECD Test Guideline 491: Short Time Exposure In Vitro Test Method for Identifying (i) Chemicals Inducing Serious Eye Damage and (ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage |
|
||
|
OECD Test Guideline 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage |
|
||
|
OECD Test Guideline 405: Acute eye irritation/corrosion |
|
||
|
OECD Test Guideline 442B: Skin Sensitisation – Local Lymph Node Assay: BrdU-ELISA |
|
||
|
OECD Test Guideline 429: Skin Sensitisation – Local Lymph Node Assay |
|
||
|
OECD Test Guideline 406: Skin sensitisation |
As the Buehler test is considered less sensitive than the maximization test, there is a preference of choice of assay for the maximisation test |
||
|
OECD Test Guideline 442A: Skin Sensitisation – Local Lymph Node Assay: DA |
|
||
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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|
— |
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||
|
— |
|
||
|
OECD Test Guideline 428: Skin absorption: in vitro method |
|
||
|
OECD Test Guideline 427: Skin absorption: in vivo method |
|
||
|
— |
|
||
|
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. |
||
|
— |
|
||
|
OECD Test Guideline 307: Aerobic and anaerobic transformation in soil |
|
||
|
ISO 10381-6:2009: Soil quality. Sampling. Guidance on the collection, handling and storage of soil under aerobic conditions for the assessment of microbiological processes, biomass and diversity in the laboratory |
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 |
||
|
ISO 18400-102:2017 ISO 18400-104:2018 ISO 18400-105:2017 ISO 18400-206:2018 |
|
||
|
— |
|
||
|
OECD Test Guideline 307: Aerobic and anaerobic transformation in soil |
|
||
|
OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides, No 82. Series on Testing and Assessmen,t No 232 |
|
||
|
— |
|
||
|
OECD Test Guideline 106: Adsorption – Desorption Using a Batch Equilibrium Method |
|
||
|
OECD Test Guideline 121: Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC) |
|
||
|
OECD Test Guideline 312: Leaching in Soil Columns |
|
||
|
OECD Test Guideline 307: Aerobic and anaerobic transformation in soil |
|
||
|
OECD Guidance Document for the Performance of Out-door Monolith Lysimeter Studies. Series on Testing and Assessment, No 22 |
|
||
|
OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides, No 82. Series on Testing and Assessment, No 232 |
|
||
|
— |
|
||
|
— |
|
||
|
OECD Test Guideline 309: Aerobic Mineralisation in Surface Water – Simulation Biodegradation Test |
|
||
|
OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems |
|
||
|
OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems |
|
||
|
EFSA guidance document on soil phototransformation products in groundwater – Consideration, parameterisation and simulation in the exposure assessment of plant protection products (PAFF-PPL-Dec 22-Doc.A.07.02) |
|
||
|
— |
|
||
|
OECD ENV/JM/MONO(2016)6 Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies Series on Pesticides No 82/Series on Testing and Assessment No 232 |
|
||
|
— |
|
||
|
— |
|
||
|
— |
|
||
|
— |
|
||
|
— |
|
||
|
— |
|
||
|
— |
|
||
|
OECD Test Guideline 223: Avian Acute oral toxicity study |
|
||
|
US EPA OCSPP 850.2100: Avian Acute Oral Toxicity Test |
|
||
|
— |
|
||
|
— |
|
||
|
Please refer to 7.1.1 |
|
||
|
— |
|
||
|
OECD Test Guideline 248: Xenopus Eleutheroembryonic Thyroid Assay (XETA) |
|
||
|
OECD Test Guideline 231: Amphibian Metamorphosis Assay |
|
||
|
OECD Test Guideline 241: Larval Amphibian Growth and Development Test |
|
||
|
— |
|
||
|
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. |
||
|
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. |
||
|
— |
|
||
|
— |
|
||
|
— |
|
||
|
— |
|
||
|
EPPO 170(4) Side-effects on honeybees |
|
||
|
OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test |
|
||
|
OECD Test Guideline 247: Bumblebee, Acute Oral Toxicity Test |
|
||
|
EPPO 170(4) Side-effects on honeybees |
|
||
|
OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test |
|
||
|
OECD Test Guideline 246: Bumblebee, Acute Contact Toxicity Test |
|
||
|
OECD Test Guideline 245: Honey bee (Apis mellifera l.), chronic oral toxicity test (10-day feeding) |
|
||
|
OECD Guidance Document on the honeybee (Apis mellifera L.) brood test under semi-field conditions (only for spray applications). Series on Testing and Assessment, No 75 |
|
||
|
OECD Guidance Document on Honey Bee Larval Toxicity Test following Repeated Exposure, Series on Testing and Assessment No 239 |
|
||
|
OECD Test Guideline No 237: Honey Bee (Apis mellifera) Larval Toxicity Test, Single Exposure |
|
||
|
Oomen PA, de Ruijter A and van der Steen J, 1992. Method for honeybee brood feeding tests with insect growth – regulating insecticides. Bulletin OEPP/EPPO Bulletin 22, 613-616 |
|
||
|
Lückmann, J. and Schmitzer, S. (2019), The Oomen bee brood feeding test – revision of the method to current needs and developments. EPPO Bulletin, 49: 137-146 |
|
||
|
OECD Guidance document on honey bee (Apis mellifera l.) homing flight test, using single oral exposure to sublethal doses of test chemical, Series on Testing and Assessment, No 332 |
|
||
|
EPPO 170(4) Side-effects on honeybees |
|
||
|
OECD Guidance Document on the Honey Bee (Apis mellifera L.) Brood test Under Semi-field Conditions. Series on Testing and Assessment, No 75 |
|
||
|
EPPO 170(4) Side-effects on honeybees |
|
||
|
Oomen PA, de Ruijter A and van der Steen J, 1992. Method for honeybee brood feeding tests with insect growth – regulating insecticides. Bulletin OEPP/EPPO Bulletin 22, 613-616 |
|
||
|
Lückmann, J. and Schmitzer, S. (2019), The Oomen bee brood feeding test – revision of the method to current needs and developments. EPPO Bulletin, 49: 137-146 |
|
||
|
— |
|
||
|
Guidelines to evaluate side-effects of plant protection products to non-target arthropods. (IOBC, BART and EPPO Joint Initiative. M.P. Candolfi, S. Blümel, R. Forster et al. (2000). ISBN: 92-9067-129-7) |
|
||
|
Guidelines to evaluate side-effects of plant protection products to non-target arthropods. (IOBC, BART and EPPO Joint Initiative. M.P. Candolfi, S. Blümel, R. Forster et al. (2000). ISBN: 92-9067-129-7) |
|
||
|
An extended laboratory test for evaluating the effects of plant protection products on the parasitic wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae) – (Mead-Briggs, M.A., Moll, M., Grimm, et al. (2010). BioControl 55:329-338) |
|
||
|
Guidelines to evaluate side-effects of plant protection products to non-target arthropods. (IOBC, BART and EPPO Joint Initiative. M.P. Candolfi, S. Blümel, R. Forster et al. (2000). ISBN: 92-9067-129-7) |
|
||
|
Guidelines to evaluate side-effects of plant protection products to non-target arthropods. (IOBC, BART and EPPO Joint Initiative. M.P. Candolfi, S. Blümel, R. Forster et al. (2000). ISBN: 92-9067-129-7) |
|
||
|
— |
|
||
|
— |
|
||
|
— |
|
||
|
OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) |
|
||
|
ISO 11268-3:2014: Soil quality – Effects of pollutants on earthworms – Part 3: Guidance on the determination of effects in field situations |
|
||
|
ISO 23611-1:2018: Soil quality – Sampling of soil invertebrates – Part 1: Hand-sorting and extraction of earthworms |
|
||
|
ISO 23611-2:2006: Soil Quality – Sampling of soil invertebrates – Part 2: Sampling and extraction of micro-arthropods (Collembola and Acarina) |
|
||
|
OECD Test Guideline 232: Collembolan Reproduction Test in Soil |
|
||
|
OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil |
|
||
|
— |
|
||
|
OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test |
|
||
|
— |
|
||
|
— |
|
||
|
OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test |
|
||
|
OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test |
|
||
|
— |
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— |
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— |
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— |
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— |
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