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9.6.2023 |
EN |
Official Journal of the European Union |
C 202/2 |
Communication from the Commission concerning Part B of the Annex to 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 202/02)
This guidance has been developed in consultation with the Member States. It does not intend to produce any legally-binding effects and, by its nature, cannot prejudice any measure taken by a Member State in the implementation of Regulation (EC) No 1107/2009, 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 Regulation (EU) No 284/2013 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 list below represents this list for Part B of the Annex to Regulation (EU) No 284/2013, as amended by Commission Regulation (EU) 2022/1440 (1), and will be updated regularly.
Where provisions of Part B of the Annex to Regulation (EU) No 284/2013 require generation of data based on requirements laid down in Part A of the Annex to Regulation (EU) No 284/2013, the relevant test methods and guidance are listed in the Commission Communication relevant to the implementation of Part A of the Annex to Regulation (EU) No 284/2013 (i.e. regarding plant protection products containing chemical active substances).
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.
Test methods
Where Commission Regulation (EC) No 440/2008 (2) provides for cross-reference to an OECD test guideline (by indicating that a test method is replicate, analogous to or equivalent to, an OECD test guideline) only the OECD test guideline is listed to avoid duplication.
Only test methods that have been validated (i.e. ring-tested by the 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 the study.
For plant protection products containing an active substance that is a micro-organism, ad-hoc test protocols may be needed to address some data requirements. During the pre-submission phase (3), applicants, the Rapporteur Member State, and EFSA may discuss this kind of ad-hoc test protocols, in particular if test protocols listed in the Commission Communication relevant to the implementation of Part A of the Annex to Regulation (EU) No 284/2013 can be used as surrogates or whether they can be adapted to be more suitable for plant protection products containing an active substance that is a micro-organism.
In view of minimising testing on vertebrate animals, tests already carried out based on older test methods should be considered as part of the risk assessment, as provided for in Article 62 of Regulation (EC) No 1107/2009. However, during the pre-submission meeting, applicants, the Rapporteur Member State and EFSA may consider whether new test according to newer test methods are needed, if scientifically justified.
In all cases, in accordance with Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (4), Regulation (EC) No 1107/2009 (Recitals 11 and 40, Articles 8.1(d), 18(b), 33.3(c) and 62.1) and Commission Regulation (EU) No 283/2013 (5), 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 products 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 (6). Furthermore, availability of guidance documents on non-animal testing and validated and reliable in–vitro study protocols should be considered as a valid scientific justification when considering point 1.5 of the Introduction of the Annex to Regulation (EU) No 283/2013.
If several test methods are available to fulfil a data requirement, the order of test methods listed indicates a preference in case a new test is needed. The order prioritises methods where no or fewer test animals are needed and/or this method is associated with less severe suffering of the test animals. However, during the pre-submission meeting, upon advice by EFSA and the Rapporteur Member State, the order of priority can be changed when scientifically justified (e.g. due to limitations of the applicability domain of some methods) in order to ensure the scientific quality of the assessment.
Guidance documents
Guidance documents qualify to be listed when they:
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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. |
The following types of guidance documents have been considered for listing:
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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 are generally not included in the list below, except for some which were subject to a public consultation.
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 the study.
As regards the EPPO standards series concerning the efficacy evaluation of plant protection products, the most relevant standards are indicated in the list below. However, the list must be considered not exhaustive since the EPPO global database is updated regularly and other standards may be needed on a case-by-case approach. Therefore, the EPPO global database, the General Standards of the EPPO standard series PP1 and the Specific Standards of the EPPO standard series PP1 are also included in the list.
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Reference to Part B of the Annex to Regulation (EU) No 284/2013 |
Test methods (7) |
Guidance documents (8) |
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General test methods and guidance documents |
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EFSA Guidance on the use of the weight of evidence approach in scientific assessments (EFSA Journal 2017;15(8):4971) |
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General test methods and guidance documents |
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ECHA Guidance on the Application of the CLP Criteria |
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General test methods and guidance documents |
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OECD Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA) No. 260 |
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General test methods and guidance documents |
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OECD Guidance Document on Good In Vitro Method Practices (GIVIMP) |
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EU Guidance document for the assessment of the equivalence of technical grade active ingredients for identical microbial strains or isolates approved under Regulation (EC) No. 1107/2009 (SANCO/12823/2012) |
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OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 |
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EU Guidance document on significant and non-significant changes of the chemical composition of authorised plant protection products under Regulation (EC) No 1107/2009 of the EU Parliament and Council on placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (SANCO/12638/2011) |
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OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65. |
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OECD Guidance document on storage stability of microbial pest control products. Series on Pesticides No. 85 (ENV/JM/MONO(2016)54) |
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CIPAC MT 39 Stability of liquid formulations at 0°C |
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CIPAC MT 46 Accelerated storage procedure |
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CIPAC MT 53 Wettability |
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CIPAC MT 47 Persistent foaming |
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CIPAC MT 41 Dilution stability of herbicide aqueous solutions |
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CIPAC MT 160 Spontaneity of dispersion of suspension concentrates |
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CIPAC MT 174 Dispersibility of water dispersible granules |
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CIPAC MT 179 Dissolution degree and solution stability |
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CIPAC MT 180 Dispersion stability Suspo-emulsions |
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CIPAC MT 184 Suspensibility of formulations forming suspensions on dilution with water |
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CIPAC MT 196 Solution Properties of Water Soluble Tablets |
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CIPAC MT 170 Dry sieve analysis of water dispersible granules |
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CIPAC MT 187 Particle size analysis by laser diffraction |
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CIPAC MT 185 Wet sieve test |
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CIPAC MT 170 Dry sieve analysis of water dispersible granules |
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CIPAC MT 171 Dustiness of granular products |
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CIPAC MT 178 Attrition resistance of granules |
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CIPAC MT 185 Wet sieve test |
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CIPAC MT 187 Particle size analysis by laser diffraction |
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CIPAC MT 193 Attrition of tablets |
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CIPAC MT 197 Disintegration of Tablets |
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CIPAC MT 36 Emulsion characteristics of emulsifiable concentrates |
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CIPAC MT 148 Pourability of suspension concentrates |
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CIPAC MT 171 Dustiness of granular products |
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CIPAC MT 172 Flowability of water dispersible granules after heat test under pressure |
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ASTM E1518 – 05 Standard Practice for Evaluation of Physical Compatibility of Pesticides in Aqueous Tank Mixtures by the Dynamic Shaker Method |
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CIPAC MT 194 Adhesion to Treated Seed |
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CIPAC MT 175 Seed treatment formulations, liquid, determination of seed-seed uniformity of distribution |
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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 |
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EPPO Global Database (9) |
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EPPO PP 1/248 Harmonized classification and coding of the uses of plant protection products (10) |
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EPPO PP1/239 Dose expression of plant protection products |
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EPPO PP1/292 Cleaning pesticide application equipment (PAE) – efficacy aspects |
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EU Guidance document: Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/2013 (SANCO/3030/99) |
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OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 |
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Residues Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830) |
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Specific Standards of the EPPO standard series PP1 (11) |
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EU guidance document on data requirements on efficacy for the dossier to be submitted for the approval of new active substances contained in plant protection products. (SANCO/10054/2013) |
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EU Guidance document on the efficacy composition of core dossier and national addenda submitted to support the authorization of plant protection products under regulation (EC) No 1107/2009 of the EU parliament and council on placing of plant protection products on the market. (SANCO/10055/2013) |
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General Standards of the EPPO standard series PP1 (12) (Efficacy evaluation of plant protection products), in particular: EPPO PP1/276 Principles of efficacy evaluation for microbial plant protection products, EPPO PP1/296 principles of efficacy evaluation for low-risk plant protection products, and, EPPO PP1/319 General principles for efficacy evaluation of plant protection products with a mode of action as plant defence inducers. |
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OECD Guidelines for Testing of Chemicals No. 208 ‘Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test’ (2006) |
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EPPO PP1/207 Effects on succeeding crops |
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EPPO PP1/256 Effects on adjacent crops |
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OECD (2006) Guidelines for the Testing of Chemicals No. 227 ‘Terrestrial Plant Test: Vegetative Vigour Test’ |
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OECD (2006) Guidelines for Testing of Chemicals No. 208 ‘Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test’ |
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EFSA Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products (EFSA Journal 2022;20(1):7032) |
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OECD (2016) Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests Series on Testing & Assessment No. 237 |
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OECD Test Guideline 423: Acute Oral toxicity - Acute Toxic Class Method |
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OECD Test Guideline 420: Acute Oral Toxicity - Fixed Dose Procedure |
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OECD Test Guideline 402: Acute Dermal Toxicity - Fixed Dose Procedure |
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OECD Test Guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method |
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OECD Test Guideline 403: Acute Inhalation Toxicity |
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OECD Test Guideline 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method |
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OECD Test Guideline 404: Acute Dermal Irritation/Corrosion |
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OECD Test Guideline 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER) |
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OECD Test Guideline 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method |
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OECD Test Guideline 435: In vitro Membrane Barrier Test Method for Skin Corrosion |
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OECD Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation, No. 203 |
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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 |
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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 |
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OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants |
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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 |
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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 |
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OECD Test Guideline 405: Acute eye irritation/corrosion |
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OECD Test Guideline 442A: Skin Sensitisation – Local Lymph Node Assay: DA |
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OECD Test Guideline 442B: Skin Sensitisation - Local Lymph Node Assay: BrdU-ELISA or –FCM |
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OECD Test Guideline 442C: In Chemico Skin Sensitisation |
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OECD Test Guideline 442D: In Vitro Skin Sensitisation |
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OECD Test Guideline 442E: In Vitro Skin Sensitisation: In Vitro Skin Sensitisation Assays Addressing the Key Event on Activation of Dendritic Cells on the Adverse Outcome Pathway for Skin Sensitisation |
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OECD Guideline No. 497: Defined Approaches on Skin Sensitisation |
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OECD Test Guideline 406: Skin Sensitisation Guinea Pig Maximisation Test and Buehler Test |
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OECD Test Guideline 429: Skin Sensitisation – Local Lymph Node Assay |
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OECD Test Guideline 428: Skin Absorption: In Vitro Method |
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OECD Test Guideline 427: Skin Absorption: In Vivo Method |
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EU Guidance on dermal absorption (SANTE/2018/10591) |
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EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) |
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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) |
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EFSA Guidance on dermal absorption (EFSA Journal 2017;15(6):4873) |
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FAO Operator exposure models and local risk assessment (13) |
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EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) |
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EFSA Guidance on the establishment of the residue definition for dietary risk assessment (EFSA Journal 2016;14(12):4549) |
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EFSA Reporting data on pesticide residues in food and feed according to Regulation (EC) No 396/2005 (2018 data collection) (EFSA Journal 2019;17(4):5655) |
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Test methods indicated either in the Commission Communication for the implementation of Part B of the Annex to Regulation (EU) No 283/2013, or in the Communication relevant to the implementation of Part A of the Annex to Commission Regulation (EU) No 284/2013 may be used as a basis and re-adapted. The applicability of the methods selected, or adaptations of them, must be justified in light of the specificities of the case at stake and it may be discussed in pre-submission meetings. |
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EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) |
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OECD Guidance to the environmental safety evaluation of microbial biocontrol agents, Series on Pesticides No. 67 (ENV/JM/MONO(2012)1) |
(1) Commission Regulation (EU) 2022/1440 of 31 August 2022 amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms (OJ L 227, 1.9.2022, p. 38).
(2) 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).
(3) Article 32a of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31 1.2.2002, p. 1).
(4) OJ L 276, 20.10.2010, p. 33.
(6) Available at https://publications.jrc.ec.europa.eu/repository/
(7) With exception of methods described in Regulation (EC) No 440/2008, most of the test methods cited are only available in English (some also in French). Detailed information about the test methods:
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CIPAC http://www.cipac.org/ |
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ASTM http://www.astm.org/Standard/index.shtml |
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ISO http://www.iso.org/iso/home/store/catalogue_ics.htm |
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OECD http://www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/ |
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EPPO http://www.eppo.int/STANDARDS/standards.htm |
(8) Most of the guidance documents cited are available only in English. Detailed information about the guidance documents:
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European Commission: https://food.ec.europa.eu/plants/pesticides/approval-active-substances/guidelines-active-substances-and-plant-protection-products_en |
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OECD http://www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/ |
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EPPO: http://www.eppo.int/STANDARDS/standards.htm |
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ECHA: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation |
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EFSA: http://www.efsa.europa.eu/en/publications.htm |
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FOCUS: https://esdac.jrc.ec.europa.eu/projects/focus-dg-sante |
(9) https://gd.eppo.int/
(10) Please consider only those uses which are deemed relevant under the scope of Reg (EC) No 1107/2009, and not those in EPPO PP 1/248 which refer to biostimulant claims as defined both under the scope of Reg (EU) No 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.
(11) EPPO standards are available at http://pp1.eppo.org/ - EPPO standards of series PP1 describe how to evaluate the efficacy of plant protection products. The series contain General Standards and Specific Standards. Specific Standards should be used together with relevant General Standards and vice versa.
(12) https://pp1.eppo.int/standards/general
(13) http://www.fao.org/pesticide-registration-toolkit/registration-tools/assessment-methods/method-detail/en/c/1187029/