Date: 15.01.2026

Summary :

The document presents EFSA’s protocol for assessing emergency authorisations of insecticides and acaricides under Article 53 of Regulation (EC) No 1107/2009, providing structured flowcharts, decision criteria, and guidance for competent authorities. It emphasises consistency, transparency, time efficiency, and alignment with EU sustainability strategies while distinguishing cases by active substance status and pest risk.

The protocol details evaluation steps for product suitability, availability of chemical and non‑chemical alternatives, resistance management, repeated authorisations, spatial/temporal restrictions, and transition to regular authorisation, and includes inventories, examples, appendices, and templates to support national-level decisions.

Key Insights and Themes

Protocol Purpose is to provide a structured, harmonised approach for assessing emergency authorisations of insecticides and acaricides, ensuring alignment with EU sustainability and biodiversity strategies.

Scope covers emergency authorisations for insecticides and acaricides, with similar protocols under development for other pesticide categories.

Flowcharts are central tools in the protocol, guiding authorities through stepwise decision-making processes to ensure consistency and efficiency.

Emergency Authorisation Definition refers to the time-limited use of pesticides in situations where no other reasonable means are available to manage the emergency.

Alternative Control Methods are systematically evaluated for effectiveness and feasibility, with only those rated highly in both areas considered viable alternatives.

Eligibility Criteria require that alternative control methods must reach level 4 effectiveness (high and consistent) and level 3 feasibility (applicable under most circumstances) to be considered suitable substitutes for emergency authorisation.

National-Level Assessment is required for alternative control methods due to the influence of local agro-environmental and socio-economic conditions.

Inventory of Alternatives is provided as supporting information to assist competent authorities in evaluating potential non-chemical solutions.

Transition to Regular Authorisation is emphasised, with emergency authorisation intended as a temporary measure and applicants expected to present action plans for long-term solutions.

Repeated Authorisations are subject to structured, time-bound action plans, with progress monitored and typically limited to a period not exceeding five years unless justified.

Resistance Management can justify emergency authorisation when resistance to existing PPPs has developed and the product under evaluation offers a different mode of action.

Integrated Pest Management (IPM) is prioritised, and emergency authorisations may be granted to maintain established IPM programmes when no alternatives exist.

Concurrent Requests for the same emergency situation are compared, with preference given to PPPs with approved active substances, higher effectiveness, better safety profiles, and lower resistance risks.

Spatial and Temporal Restrictions are applied to emergency authorisations, limiting use to affected areas and specific timeframes, with possible conditions on application methods and end-user groups.

Post-Authorisation Obligations may include implementation of non-chemical methods, monitoring of intervention success, and reporting on the range and frequency of PPP use.

Transparency and Stakeholder Input are integral, with workshops and consultations informing protocol development and criteria.

Flexibility is built into the protocol to accommodate a variety of emergency scenarios and to adapt to evolving threats, technologies, and alternative solutions.

Regular Review of the protocol and alternative methods inventory is recommended to ensure alignment with scientific advances and changing circumstances.

Implementing this protocol is expected to strengthen the EU’s ability to respond effectively to agricultural emergencies while advancing sustainable plant protection practices.

SOURCE DOCUMENT

Reference n° ENV/CBC/MONO(2025)18

Date: 31.10.2025

Overview:

This OECD Guidance Document sets out best-practice approaches to improve generation, reporting, sharing and regulatory use of research data for chemical hazard and risk assessments. It defines reporting, reliability and relevance principles, and emphasises FAIR data, tailored reporting templates, and tools to bridge non-standard academic data with regulatory evidence needs.

The Guidance describes workflows for researchers and assessors: designing studies for regulatory utility, structured literature searching and screening, use of evaluation tools (e.g., SciRAP, CRED), systematic review methods, and case studies illustrating integration of research data into regulatory decisions and recommendations for harmonised practices.

Main points

- Regulatory Uptake of Research Data: Improving the use of non-standard research data in regulatory chemical assessments enhances scientific robustness and supports legal requirements to consider all available evidence.

• - Stakeholder Responsibilities: Researchers, funders, publishers, reviewers, repository managers, and risk assessors all share responsibility to increase the regulatory utility and uptake of research data throughout its lifecycle.
• - Principles of Data Quality: High-quality reporting, reliability (internal validity), and regulatory relevance (external validity) are essential for research data to be useful in regulatory contexts.
• - Reporting Standards and Templates: Adhering to established reporting standards (such as OECD Harmonised Templates, ARRIVE, STROBE, SciRAP, CRED) and using structured data repositories maximises data accessibility, transparency, and reuse.
• - Systematic Review and Evidence Integration: Structured approaches such as systematic reviews and systematic evidence maps (SEMs) are recommended for identifying, screening, evaluating, and integrating research data in regulatory assessments.
• - Fit-for-Purpose Evaluation Tools: Use of clear, context-appropriate evaluation tools and critical appraisal methods is necessary for transparent, consistent assessment of study reliability and relevance; qualitative tools are preferred over simple scoring systems.
• - Publication of All Results: Both positive and negative (no-effect) results should be published and made accessible to avoid bias, support model development, and prevent unnecessary repetition of studies, especially animal studies.
• - Recommendations for Harmonisation and Training: Adoption of harmonised reporting, evaluation tools, and ongoing training for all stakeholders is critical to improve the quality, consistency, and regulatory acceptance of research data.

Citations:

Please cite this publication as:
OECD (2025), OECD Guidance Document on the Generation, Reporting and

Use of Research Data for Regulatory Assessments, OECD Series on Testing and Assessment, No. 417, OECD Environment, Health and Safety, Paris, https://one.oecd.org/document/ENV/CBC/MONO(2025)18/en/pdf

SOURCE DOCUMENT

Reference n° ENV/CBC/MONO(2025)19

Date: 30.10.2025

Overview:

This OECD guidance details a comprehensive, updated framework for grouping chemicals—via analogue and category approaches—to support hazard assessment, reduce animal testing, and inform regulatory decisions. It integrates traditional methods with New Approach Methodologies (NAMs), (Q)SARs, omics, AOPs, and IATA/Defined Approaches to improve read-across, trend analysis, and uncertainty characterization.

The third edition provides stepwise workflows, reporting templates, tools, and case studies for selecting analogues, forming categories, and documenting read-across justifications across diverse substance types (including UVCBs, metals, nanomaterials), emphasizing applicability domains, data quality, and iterative review.

Main points:

Chemical Grouping Approaches : Grouping chemicals enables hazard assessment by considering structurally or mechanistically similar chemicals together, using either analogue (one-to-one or few-to-few) or category (many-to-many) approaches to fill data gaps and reduce animal testing.

Read-Across and Data Gap Filling : Read-across uses data from one or more source chemicals to predict properties or hazards of a target chemical lacking data, and can be qualitative (binary) or quantitative (numerical value); it is central to both analogue and category approaches.

Category Formation and Trends : Categories are defined by common structural, physicochemical, or mechanistic features, and allow for the identification of trends (e.g., toxicity, potency) across members, which supports interpolation and extrapolation to fill data gaps.

Uncertainty Assessment : Evaluation of uncertainties is essential in grouping and read-across, considering data quality, similarity rationale (structural, physicochemical, metabolic, bioactivity, MOA), and robustness of predictions; multiple frameworks and templates exist for systematic uncertainty assessment.

Role of New Approach Methodologies (NAMs) : NAMs, including in vitro assays, omics (transcriptomics, metabolomics), high-throughput/content screening (HTS/HCS), and computational models ((Q)SARs), provide supporting evidence for similarity, mechanistic justification, and can increase confidence in grouping.

Applicability Domain and Boundaries : Clearly defining the applicability domain—structural, physicochemical, and mechanistic boundaries—determines which chemicals can be reliably included in a group or category and supports regulatory acceptance.

Reporting and Documentation : Transparent documentation is required, including the rationale, data matrices, justification for inclusion/ exclusion, uncertainty analysis, and reporting formats for analogue and category approaches, often using modular templates and data matrices.

Special Considerations for Complex Substances and Nanomaterials : Grouping and read-across principles apply to substances of unknown or variable composition (UVCBs), metals, inorganics, and nanomaterials, but require additional attention to compositional, physicochemical, and transformation characteristics due to their complexity and variability.

Summary

Introduction

This document provides comprehensive guidance on the grouping of chemicals for hazard assessment, offering methodologies to increase efficiency, reduce animal testing, and ensure scientific robustness in regulatory and scientific contexts.

Key Insights and Themes

• Grouping Approaches enable the assessment of chemicals as analogues or categories, allowing data from tested chemicals to predict properties of untested ones, thus reducing the need for extensive testing.

• Analogue Approach uses empirical data from one or more structurally or mechanistically similar chemicals to predict properties for a specific target chemi- cal, emphasizing the importance of shared mode or mechanism of action.

• Category Approach organizes chemicals into groups with similar or regularly patterned properties, supporting hazard assessment through trend analysis and read-across within the group.

• Read-Across and Data Gap Filling are central techniques, where information from one chemical or group is used to fill data gaps for others, and can be applied qualitatively or quantitatively.

• Uncertainty Analysis is integral, requiring systematic identification, characteri- zation, and documentation of uncertainties in both data and similarity rationales to ensure robust predictions.

• New Approach Methodologies (NAMs), such as in vitro assays, omics tech- nologies, high-throughput screening, and computational models, are increasingly used to substantiate similarity and support grouping hypotheses.

• Bioactivity Similarity leverages biological response data (e.g., from omics or HTS/HCS) as evidence for grouping, with confidence strengthened by mechanistic links to endpoints or adverse outcome pathways.

• Adverse Outcome Pathways (AOPs) provide mechanistic frameworks linking molecular events to adverse effects, supporting grouping and read-across by clari- fying the biological plausibility of groupings.

• Integrated Approaches to Testing and Assessment (IATA) and Defined Ap- proaches (DA) combine multiple evidence sources, including grouping, to guide hazard and risk assessment in a structured manner.

• Applicability Domains and Boundaries must be clearly defined for both ana- logues and categories, specifying structural, physicochemical, and mechanistic cri- teria for group membership and reliable predictions.

• Subcategories and Breakpoints may arise within categories when trends do not apply uniformly, requiring endpoint-specific justifications and potentially lead- ing to subcategorization for regulatory clarity.

• Regulatory Context and Evolution drive the development of grouping guid- ance, with frameworks like EU REACH and ECHA’s Read-Across Assessment Frame- work (RAAF) shaping scientific and documentation standards.

• Reporting Formats for analogue and category approaches are standardized to ensure transparency, reproducibility, and comprehensive justification, including data matrices and explicit uncertainty assessments.

• Computational Tools such as the OECD QSAR Toolbox, GenRA, and others support analogue identification, trend analysis, and category development by pro- viding systematic and reproducible methods.

• Special Considerations are addressed for complex substances (UVCBs), met- als, inorganic compounds, and nanomaterials, with tailored grouping and read- across strategies reflecting their unique characteristics and data challenges.

• Weight of Evidence (WoE) Approaches are recommended to integrate multi- ple lines of evidence, address data gaps, and support regulatory decision-making with transparent confidence assessments.

• Continuous Evolution of the guidance is expected, reflecting advances in sci- ence, technology, and regulatory experience, with periodic updates to incorporate new data sources, methodologies, and case studies.

• International Collaboration underpins the development and harmonization of grouping approaches, with contributions from global regulatory agencies, scientif- ic experts, and industry stakeholders.

Conclusion

Grouping of chemicals, supported by robust methodologies, uncertainty analysis, and evolving scientific tools, enables more efficient, ethical, and scientifically sound hazard assessment for regulatory and research purposes.

Citation: not available

SOURCE DOCUMENT

Reference n°: ENV/CBC/MONO(2025)17

Date: 24.10.2025

Overview:

The document presents OECD findings from the ninth review cycle (2023) of Integrated Approaches for Testing and Assessment (IATA) case studies, summarising lessons from three submissions on agrochemical carcinogenicity read-across, surfactant eye-irritation defined approaches, and bioaccumulation IATAs. It explains project aims, templates, review processes, and the scope of OECD guidance linking New Approach Methods (NAMs), AOPs, and weight-of-evidence (WoE) applications.

Key takeaways include methodological strengths and uncertainties for analogue selection by mode of action, the Defined Approach for Surfactants (DASF) performance and limits, and approaches to scoring and integrating evidence for bioaccumulation. The report identifies priority topics for further guidance, such as uncertainty analysis, applicability domains, PBK/IVIVE, and confidence-building with limited reference chemicals.

Summary

This document reviews the ninth cycle (2023) of OECD case studies on Integrated Approaches for Testing and Assessment (IATA) for chemical safety, highlighting new methodologies, lessons learned, and future guidance needs.

Key Insights and Themes

Global Expansion of NAMs reflects the increased use of New Approach Methods (NAMs) for chemical safety assessment, driven by the need to reduce animal testing and leverage advances in biotechnology.

OECD Guidance Development includes creation of documents and tools supporting NAMs, such as in silico, in chemico, in vitro, and in vivo methods, and guidance for Adverse Outcome Pathways (AOPs).

IATA Case Study Project (CSP) was launched to facilitate sharing and review of real-world applications of IATAs and promote regulatory acceptance.

Annual Review Cycle involves expert review and discussion of submit- ted case studies, focusing on strengths, uncertainties, and regulatory relevance, with findings published for transparency.

Ninth Review Cycle (2023) examined three case studies: chronic toxicity and carcinogenicity of agrochemicals, eye hazard identification of surfactants, and bioaccumulation assessment.

Analogue Selection for Read-Across in carcinogenicity assessment prioritizes mode of action (MoA) or biological response over structural similarity, with detailed justification and uncertainty analysis required.

Defined Approach for Surfactants (DASF) was developed for eye irritation testing, demonstrating high predictive accuracy across surfactant classes but limited by the small number of Cat. 2 reference chemicals.

Weight of Evidence (WoE) Scoring is context-dependent; transparent, fit-for-purpose scoring and weighting of lines of evidence are essential for integrating diverse data in bioaccumulation assessments.

Uncertainty Assessment is a recurring challenge, with frameworks and templates provided to systematically document and communicate uncertainty in read-across and WoE approaches.

Regulatory Applicability varies by country and sector; while many approaches are promising, barriers include data availability, validation of new methods, and regulatory requirements for specific endpoints.

IATA Framework Template was introduced to standardize and facilitate the reuse of IATA case studies, with ongoing improvements planned for endpoint-specific applications.

Guidance Priorities Identified include increasing confidence in IATA/ DA performance with limited reference chemicals, integrating multiple data streams, defining applicability domains, and improving uncertainty analysis.

Limitations and Needs highlight the need for further validation, broader chemical coverage, improved reporting, and harmonization of approaches for complex endpoints like carcinogenicity and bioaccumulation.

Examples and Templates for reporting, data matrices, and uncertainty assessment are provided to enhance reproducibility and clarity in future case studies.

Stakeholder Engagement in the review process ensures diverse regulatory perspectives and identifies practical challenges in applying IATAs to real-world assessments.

Continuous Improvement is driven by lessons learned from each review cycle, with feedback informing updates to templates, guidance documents, and regulatory practices.

Transparency and Documentation are emphasized throughout, with detailed templates and reporting formats to support regulatory acceptance and scientific rigor.

International Harmonization is an overarching goal, with the OECD facilitating the development of common frameworks and guidance to support global regulatory use of IATAs and NAMs.

Conclusion

The ninth review cycle advances the development and regulatory application of IATAs and NAMs, identifying key challenges and priorities for future guidance to support global chemical safety assessment.

Citation:

OECD (2025), REPORT ON CONSIDERATIONS FROM CASE STUDIES ON INTEGRATED APPROACHES FOR TESTING AND ASSESSMENT (IATA) Ninth Review Cycle (2023), OECD Series on Testing and Assessment, No 416, OECD Environment, Health and Safety, Paris, https://one.oecd.org/official-document/ENV/CBC/ MONO(2025)17/en

SOURCE DOCUMENT

Reference n° ENV/CBC/MONO(2025)16

Date: 14.10.2025

Overview:

The OECD monograph presents Integrated Approaches for Testing and Assessment (IATA) using combined bioinformatics tools to extrapolate chemical toxicity across species. It details the complementary use of SeqAPASS and G2P-SCAN to evaluate protein and pathway conservation, supporting hazard identification, prioritization, and regulatory decision-making while reducing animal testing.

The document describes workflows, case studies (PPARα, ESR1, GABRA1), tool inputs/outputs, uncertainties, and regulatory applications (ERA, endocrine disruption, endangered species). It provides method guidance, software instructions, and evidence synthesis strategies for implementing NAMs in cross-species chemical safety assessments.

Main points:

Bioinformatics Integration: Combining the SeqAPASS and G2P-SCAN computational tools enables robust cross-species extrapolation of chemical toxicity by assessing both protein target and biological pathway conservation, supporting more informed chemical safety assessments while reducing animal testing.

Key Tools: SeqAPASS predicts species susceptibility to chemicals by evaluating protein sequence and structural conservation across thousands of species, while G2P-SCAN analyzes the conservation of biological pathways using human gene inputs and model organisms.

Regulatory Relevance: These approaches align with global regulatory trends favoring New Approach Methodologies (NAMs), facilitating mechanistic, transparent, and ethical chemical risk assessments that minimize reliance on animal testing.

Workflow Process: The integrated workflow involves identifying a chemical’s molecular target, mapping its associated biological pathways, prioritizing key pathway proteins, and using both tools to predict conservation and susceptibility across species, which informs regulatory decision-making.

Expert Judgment Requirement: Critical steps such as target identification, isoform selection, and pathway prioritization rely on expert judgment, often requiring literature review, evaluation of empirical evidence, and knowledge of protein structure-function relationships.

Limitations: The approach is limited by the availability and quality of protein and gene sequence data, incomplete pathway annotation in non-model species, and is most applicable when the chemical’s molecular target is known and well characterized.

Regulatory Applications: Results are used for hazard identification, prioritization, and as additional lines of evidence in weight-of-evidence evaluations for regulatory frameworks such as the Endangered Species Act, endocrine disruptor screening, and pesticide registration.

Case Study Outcomes: Application to chemicals like 2-ethylhexanoic acid, diethylstilbestrol, and topiramate demonstrated that consensus between SeqAPASS and G2P-SCAN enhances confidence in predicting pathway conservation and chemical susceptibility across mammalian and other vertebrate species.

Summary

Introduction

This document presents integrated bioinformatics approaches for extrapolating chemical toxicity knowledge across species to inform chemical safety assessments, aiming to reduce reliance on animal testing and improve regulatory decision-making.

Key Insights and Themes

• Global regulatory shift increasingly favors New Approach Methodologies (NAMs), such as computational and cell-based tools, to assess chemical safety in an ethical, efficient, and scientifically robust manner.

• Cross-species extrapolation is essential for chemical risk assessment, enabling predictions about chemical effects in untested or protected species based on data from surrogate organisms.

• Traditional methods like safety factors and species sensitivity distributions have limitations due to assumptions about interspecies relatedness and data availability.

• Bioinformatics tools—notably SeqAPASS (Sequence Alignment to Predict Across Species Susceptibility) and G2P-SCAN (Genes-to-Pathways Species Conser- vation Analysis)—enable systematic evaluation of protein and pathway conservation across species.

• SeqAPASS assesses protein sequence and structural conservation to predict potential chemical-protein interactions across thousands of species, supporting chemical susceptibility predictions.

• G2P-SCAN analyzes conservation of biological pathways using human gene inputs, mapping orthologs and functional families across key model species to infer pathway conservation.

• Combined application of SeqAPASS and G2P-SCAN strengthens the weight of evidence by integrating molecular (protein) and pathway-level data, enhancing confidence in species extrapolation.

• Integrated approach supports hazard assessment, prioritization in early screening, and intelligent test design by identifying the most biologically relevant species for further testing.

• Regulatory context is evolving to accept mechanistic, cell-based, and computational data, requiring transparent, scientifically robust methods for cross-species extrapolation.

• Applicability domain for these approaches requires a known chemical-biomolecule interaction in at least one species and relies on high-quality sequence and annotation data.

• Workflow involves identifying chemical targets, mapping pathways, prioritizing key proteins, and combining evidence from both tools to generate lists of susceptible species.

• Expert judgment is critical at multiple decision points, including target selection, isoform choice, and interpretation of orthology and pathway conservation results.

• Uncertainties arise from incomplete knowledge of chemical-protein interactions, taxonomic coverage, and lack of empirical evidence for some pathways or species, but can be reduced by integrating multiple data sources.

• Case studies demonstrate the approach using chemicals such as 2-ethylhexanoic acid (PPARα target), diethylstilbestrol and butylparaben (ESR1 target), and topiramate (GABRA1 target), showing practical application and limitations.

• Results from combined approaches provide lists of species likely to be susceptible based on pathway and protein conservation, supporting regulatory decisions for hazard identification, prioritization, and species protection.

• Links to Adverse Outcome Pathways (AOPs) allow mapping of molecular and functional data to regulatory-relevant outcomes, helping to define the biologically plausible taxonomic domain of applicability (tDOA) for AOPs.

• Regulatory applications include support for the Endangered Species Act, endocrine disruptor screening, and pesticide registration, by identifying at-risk species and guiding intelligent testing strategies.

• Open-source and accessibility of tools like SeqAPASS and G2P-SCAN, along with transparent workflows, facilitate broader adoption and continuous improvement as more sequence data become available.

Conclusion

Integrating computational bioinformatics tools like SeqAPASS and G2P-SCAN enables more transparent, scientifically robust, and ethically responsible cross-species extrapolation for chemical safety assessment, supporting regulatory decisions and reducing reliance on animal testing.

Citation:

OECD (2025), Case Studies for the Integrated Approaches for Testing and Assessment in the Application of Combined Bioinformatics Approaches for Cross Species Extrapolation of Toxicity Knowledge to inform Chemical Safety. Tenth Review Cycle (2024), OECD Series on Testing and Assessment, No 415, OECD Environment, Health and Safety, Paris, https://one.oecd.org/official-document/ENV/CBC/ MONO(2025)16/en

SOURCE DOCUMENT (link)

Reference n°254

Date: 25.06.2025

Summary :

This OECD test guideline specifies a laboratory method to assess acute contact toxicity of chemicals to adult solitary mason bees (Osmia spp.), aiming to determine 48 h LD50 values and record sublethal effects. It defines organism selection, dosing by topical thoracic application, controls, reference substance use, and validity criteria for reliable toxicity estimation.

The document details experimental procedures including hatching and handling, feeding and cage requirements, analytical verification, test conditions, observation schedules, statistical analysis, reporting requirements, and special notes for difficult substances and limit tests to ensure reproducible, regulatory-quality results.

Main points

Test Purpose : Assesses acute contact toxicity (LD50) of chemicals to adult solitary bees, primarily Osmia bicornis and Osmia cornuta, by topical application to determine inherent toxicity and inform risk assessments for pollinators.

Test Organism Selection : Uses recently emerged, healthy female solitary bees of similar size and weight, with selection based on visual inspection and individual weighing to minimize susceptibility variation.

Exposure Method: Applies 1–3 µL of test solution directly to the dorsal thorax of anesthetized bees, followed by housing in groups with ad libitum access to 50% sucrose solution; mortality and sublethal effects are monitored for 48–96 hours.

Controls And Reference: Includes both water and solvent/wetting agent controls, plus a reference substance (e.g., dimethoate at 2.0 µg/bee) to validate test sensitivity (≥50% mortality in reference group).

SOURCE DOCUMENT

European Food Safety Authority (EFSA)

Date: LAST UPDATE: 3 June 2024

Introduction :

This document provides updated administrative guidance for the preparation, submission, and assessment of dossiers and reports for the peer-review of pesticide active substances and maximum residue level (MRL) applications in the EU.

Key insights and themes :

Scope covers applications for the approval, amendment, or renewal of pesticide active substances and MRLs, applying to all submissions from 27 March 2021 onwards, reflecting regulatory changes and enhanced transparency requirements.

Legal framework is based on Regulation (EC) No 1107/2009, Regulation (EC) No 396/2005, and the Transparency Regulation (EU) 2019/1381, incorporating new provisions into the General Food Law.

Transparency Regulation introduces mandatory pre-submission activities, public consultations, and proactive disclosure of non-confidential information, aiming to increase transparency in the risk assessment process.

Pre-submission Phase requires applicants to register in Connect.EFSA, obtain a pre-application ID, and, for renewals, notify EFSA of intended studies with sufficient lead time for public consultation and advice.

General Pre-submission Advice (GPSA) can be requested by applicants from EFSA or rapporteur/Evaluating Member States to clarify procedural or data requirements before dossier submission; advice is documented and made publicly available.

Study Notification Obligations mandate that all studies commissioned or performed from 27 March 2021 must be notified to EFSA before their start, with unique study IDs included in dossiers; non-compliance affects admissibility.

Dossier Preparation must use the IUCLID software, following specific data formats, templates, and guidance; dossiers must include full study reports, summaries, literature, confidentiality requests, and relevant notifications.

Submission Process uses the EFSA Application Submission Portal, automatically notifying all relevant authorities and making non-confidential versions available on the OpenEFSA portal upon admissibility.

Admissibility Checks are performed by rapporteur/Evaluating Member States using checklists; applications lacking proper study notification or required elements are deemed inadmissible but may be resubmitted with corrections.

Confidentiality Requests must be justified by applicants and are assessed either by the RMS (for new approvals) or EFSA (for renewals and MRLs), with rejected claims requiring dossier updates and public disclosure of non-confidential information.

Public Consultation occurs on admissible dossiers and assessment reports, allowing third parties to submit comments; all feedback is made public and must be addressed in the assessment process.

Assessment Report Preparation is the responsibility of the RMS, using IUCLID report generator tools and standardized formats; reports must clearly distinguish applicant data from RMS conclusions and address all public comments.

Re-submission Procedures are defined for cases where applications are found inadmissible or require updates due to new information, administrative changes, or confidentiality decisions.

MRL Applications follow a similar process but include specific guidance for confirmatory data, evaluation by the Evaluating Member State, and additional reporting requirements.

Interaction with EFSA is supported throughout the application life-cycle, with dedicated tools, user guides, and special support for SMEs.

Withdrawal of Applications can occur at any stage, with clear rules on handling confidential information and the effects on public records and regulatory processes.

Continuous Updates to the guidance are planned in line with legislative changes and experience, and applicants are advised to always consult the latest version.

Conclusion

The guidance establishes a transparent, harmonized, and efficient process for the EU peer-review of pesticide active substances and MRL applications, clarifying roles, timelines, and requirements to improve dossier quality, regulatory compliance, and stakeholder engagement.

SOURCE DOCUMENT

Reference n°doi: 10.2903/j.efsa.2023.8194

Date: 14.07.2023

Overview:

This guidance establishes a tiered framework for assessing how drinking-water treatment processes transform residues of active substances (from plant protection and biocidal products) and their environmental metabolites, determining whether harmful treatment transformation products (tTPs) may form in surface water, groundwater or bank filtrate used for drinking‑water production. It prescribes exposure screening, PEC calculations, dilution factors per EU regulatory zone, and criteria to identify substances that trigger further tTP assessment.

It then details laboratory and in‑silico approaches to predict and confirm tTP formation across common processes (chlorination, chloramination, ClO2, ozonation, UV, advanced oxidation, sand/GAC filtration), and provides a three‑tiered human and domesticated‑animal hazard and risk assessment pathway emphasizing genotoxicity screening, avoidance of unnecessary vertebrate testing, and use of weight‑of‑evidence and alternative methods.

Summary of key points impacting PPPs

The guidance document introduces several critical requirements and procedures that directly impact the approval and authorisation of PPPs, particularly regarding their residues and transformation products in drinking water:

Tiered Risk Assessment Framework

A tiered framework is established to assess the risk of PPP active substances (AS) and their environmental transformation products (eTPs) in water abstracted for drinking water production. This aims to identify whether harmful treatment transformation products (tTPs) may form during water treatment and how to assess their impact on human and animal health (pages 1, 3 and 9).

The framework is designed to avoid unnecessary testing, especially vertebrate testing, and to use weight-of-evidence and alternative methods whenever possible (pages 3 and 10).

Exposure Assessment and Trigger Values

The guidance requires calculation of Predicted Environmental Concentrations (PECs) for AS and eTPs in both surface water and groundwater that may be used for drinking water (p.3 and 11).

Dilution factors are applied to surface water PECs to estimate concentrations at drinking water abstraction points. These factors differ by European regulatory zone (Central: 2, South: 5, North: 10) and are further refined by land-use type (pages 4, 18 and 86).

Substances with PECs above 0.1 μg/L at the abstraction point must be assessed for their potential to form tTPs during water treatment (p. 3, 14 and 29).

Identification and Assessment of Transformation Products

Both the parent AS and their main eTPs must be considered for literature review, modelling, and experimental testing to determine if tTPs are formed during drinking water treatment (p. 33, 34).

Experimental approaches involve first testing at high concentrations to detect possible tTPs, then repeating at environmentally relevant concentrations. Only tTPs detected above 0.075 μg/L in the final water require full identification and risk assessment (p. 33, 34, 35).

Common treatment processes considered include rapid sand filtration, chlorination, chloramination, chlorine dioxide, ozonation, and UV disinfection (p. 32, 36).

Hazard and Risk Assessment of tTPs

A three-tiered risk assessment is applied to tTPs:

Tier 1: Genotoxicity screening (using QSARs, read-across, or experimental data). Non-identified tTPs above 0.075 μg/L are considered genotoxic unless proven otherwise (p.44).

Tier 2: General toxicity assessment, comparing aggregate exposure to health-based guidance values (HBGVs) or Thresholds of Toxicological Concern (TTC) (p.48).

Tier 3: Further targeted testing if specific hazards (e.g., neurotoxicity, endocrine disruption) are suspected (p.50).

If a tTP does not pass the hazard or risk assessment, its presence at relevant concentrations is unacceptable and may preclude PPP approval or trigger mitigation (p. 44, 49, 50).

Data Requirements and Modelling Tools

Applicants must use agreed EU models (e.g., FOCUS Surface Water and Groundwater Scenarios, TOXSWA, PEARL, PELMO, PRZM) for PEC calculations (p. 13, 16, 20).

Substance-specific data, including degradation rates, sorption coefficients, and transformation pathways, must be provided (p. 13, 16).

Existing data from environmental fate and metabolism studies should be utilised before conducting new tests (p. 23).

Mitigation and National Considerations

If risks are identified, mitigation measures (e.g., buffer zones, application restrictions) must be considered and implemented in the risk assessment (p. 17, 49).

Note that national authorities may require additional scenario assessments.

SOURCE DOCUMENT

Date: July 2023

Original title (NL) : Species Sensitivity Distributions (SSD) in de risicobeoordeling van gewasbeschermingsmiddelen.

Verkenning van het gebruik voor terrestrische niet doelwit arthropoden en bodem organismen

Overview:

This report evaluates the applicability of Species Sensitivity Distributions (SSD) for assessing risks of pesticides to terrestrial non-target arthropods (NTA) and soil organisms, using toxicity endpoints extracted from the US EPA ECOTOX database for five insecticides. It compares acute (2–10 d) and chronic (11–35 d) NOEC data, evaluates dataset sufficiency, and derives HC5 values to assess protection thresholds.

Findings show SSDs can be constructed for NTA for the selected substances, but soil organisms often lack enough independent NOECs to form robust SSDs. Combining NTA and soil endpoints can change HC5 outcomes—sometimes yielding more conservative thresholds—highlighting SSDs’ potential to refine Tier‑1 risk assessment and the need for broader substance coverage and harmonized endpoints.

Summary

Introduction

This report explores whether Species Sensitivity Distributions (SSDs) can improve pesticide risk assessment for terrestrial non-target arthropods and soil organisms.

Key Insights and Themes

- Aim of the assessment is to test whether enough data exist to build SSDs, compare sensitivities of soil organisms vs above-ground non-target arthropods (NTA), and see what changes when both groups are combined for estimating the HC5 (threshold affecting <5% of species).

- Data source is the US EPA ECOTOX database, from which terrestrial invertebrate toxicity endpoints were extracted for both soil-dwelling and above-ground species.

- Endpoint choice focuses on NOEC/NOEL values (instead of 50% effect values) and includes both lab and field studies.

- Time-window stratification splits endpoints into acute (2–10 days) and chronic (11–35 days) to keep exposure durations comparable; 56-day earthworm tests were excluded by this filter.

- Unit harmonization enables combining soil and NTA endpoints by converting to an exposure metric of grams active substance per hectare (g a.s./ha).

- Chemical selection covers five insecticides with differing sorption/hydrophobicity: dimethoate, imidacloprid, chlorpyrifos, lambda-cyhalothrin, and deltamethrin.

- NTA SSD feasibility is demonstrated for all five insecticides for both acute and chronic periods, meaning sufficient NTA endpoints were available to construct SSDs.

- Soil-organism SSD feasibility is not achieved per substance because too few soil endpoints were available to meet the minimum requirement (noted as at least eight independent endpoints).

- Data-type imbalance shows soil endpoints are mostly from lab studies, while NTA endpoints are mostly from field studies, limiting the possibility to analyze only one study type without losing overlap.

- Sensitivity pattern (pyrethroids) indicates tested NTAs are clearly more sensitive than soil organisms for lambda-cyhalothrin and deltamethrin in both acute and chronic SSDs.

- Sensitivity pattern (other insecticides) shows soil-organism sensitivity generally falls within the overall NTA range for dimethoate, imidacloprid, and chlorpyrifos, rather than consistently being among the least sensitive species.

- Most-sensitive endpoint exception occurs for chlorpyrifos, where the most sensitive endpoint in both acute and chronic SSDs is a soil organism; in most other cases the most sensitive endpoint is an NTA.

- Combined SSD interpretation treats selecting the most sensitive endpoint per species (when multiple exist) as a conservative approach when merging NTA and soil endpoints.

- Acute HC5 effect of combining datasets yields an HC5 that is similar or more sensitive than NTA-only for dimethoate, imidacloprid, chlorpyrifos, and lambda-cyhalothrin; deltamethrin is the exception noted.

- Deltamethrin HC5 artefact arises because adding extremely high (insensitive) soil NOECs flattens the SSD curve, lowering the HC5 without adding very low (highly sensitive) values.

- Chronic HC5 effect of combining datasets consistently shifts HC5 to a more sensitive value for all five substances when soil endpoints are added, with the same deltamethrin caveat about curve flattening.

- Tier-1 coverage gap is suggested when soil organisms have sensitivities comparable to NTAs, because this may not be captured by current Tier-1 approaches; combining NTA and soil data in SSDs is presented as a promising extension needing testing across more active substances.

Conclusion

SSDs can be constructed for above-ground non-target arthropods for the five insecticides, but soil-organism data are often too sparse per substance, and combining soil and NTA endpoints can yield more sensitive HC5 thresholds—highlighting potential gaps in current Tier-1 risk assessment.

SOURCE DOCUMENT (NL)

Reference : 10.2903/j.efsa.2022.7032

Date: 30/11/2021

This updated EFSA guidance explains how to assess and calculate non-dietary (systemic) exposure to plant protection products (PPPs) for four exposed groups: operators, workers, residents, and bystanders, for use in EU regulatory risk assessment, and it is accompanied by an updated online exposure calculator. This 2021 update (published 2022) supersedes the earlier EFSA guidance (2014). It explicitly notes that the European Commission will decide timing for mandatory use in regulatory context.

What the guidance is about:

This 2021 guidance supports risk assessors/applicants in quantifying potential systemic exposure (mainly dermal and inhalation) as part of regulatory risk assessment for PPP uses under Good Agricultural Practice (GAP) and it standardises routine assessments using deterministic methods within a tiered approach (first-tier standardised methods, with higher-tier/ad hoc refinement when justified).

It defines and provides assessment methods for operators (mixing/loading, applying, cleaning/maintenance during application), workers (re-entry into treated areas / handling treated crops), bystanders (short-duration, incidental presence near application—acute exposure focus), and residents (people living/working/schooling adjacent—potential repeated presence—short-term exposure focus).

The 2021 guidance uses acute vs short-term (repeated) risk assessment concepts, linked to comparison with AAOEL (acute) and AOEL (short-term). Default percentile choices are 95th percentile for acute exposure estimates and 75th percentile as starting point for longer-term/short-term estimates.

The 2014 guidance had scenarios mainly for operators during outdoor uses; the update adds greenhouse scenarios.

The update also revises defaults using additional evidence and more recent sources: Crop-related defaults updated, including revised approaches/defaults for DFR (dislodgeable foliar residue), DT50 (foliar dissipation half-life), and TC (transfer coefficients).

A part from that, human default values are updated for items such as inhalation rates and surface areas, with alignment to more recent international/EU sources and harmonisation with other EU frameworks.

Compared with the earlier annexed calculator approach, the tool was further developed into an online tool with additional capabilities, including new scenarios and updated defaults (including greenhouse-related), calculation for multiple active substances in one product, safe re-entry interval calculation for workers and automated report generation with detailed results.

The updated guidance highlights improvements such as revised crop groupings and expanded re-entry activities (e.g. inspection extended more broadly), additional functionality related to worker re-entry and dermal absorption, and inclusion of exposure to soil-borne residue (with an appendix and calculator implementation).

The update provides explicit recommendations for design/conduct/interpretation of higher-tier field studies (human exposure studies and studies for refining crop parameters), collected in a dedicated appendix.

It specifies that for combined exposure from ≥2 active substances in a PPP, dose addition is assumed by default unless justified otherwise.

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SOURCE DOCUMENT

Reference n°247

Date: 9.10.2017

Overview:

This OECD test guideline specifies a laboratory method to determine acute oral toxicity (LD50, NOED) of pesticides and chemicals to adult worker bumblebees (Bombus spp.) using single-housed workers fed treated 50% sucrose solution. It covers test design, dosing, controls, analytical verification, observation times up to 96 hours, validity criteria, and data reporting requirements for regulatory risk assessment.

The protocol details colony selection, acclimatisation, feeding procedures, housing, environmental conditions, non-feeder handling, limit and dose-response tests, use of reference substances, and required study-report content including raw data, measured concentrations, statistical analyses, and documentation of deviations

Main points

Purpose: Assesses acute oral toxicity of chemicals (e.g., pesticides) to adult worker bumblebees using laboratory tests to determine LD50 and evaluate potential pollinator risk.

Test Species: Uses adult worker bumblebees, primarily Bombus terrestris and Bombus impatiens, collected from medium-sized colonies with active brood and a laying queen; excludes drones, queens, and very small or large individuals.

Exposure Method: Individual bumblebees are housed singly and fed 50% (w/v) sucrose solution containing the test chemical; exposure lasts up to 4 hours, followed by ad libitum feeding with untreated sucrose solution.

Controls and Reference: Includes water and, if needed, solvent controls, plus a toxic reference substance (e.g., dimethoate) to confirm test system sensitivity.

Replication and Randomization: Requires at least 30 replicates per treatment (50 for limit tests), with bumblebees randomized across treatments and sourced from at least three different colonies to avoid colony effects.

Validity Criteria: Test is valid if control mortality is ≤10% and reference substance mortality is ≥50% at the end of the test.

Data Recording: Mortality and sublethal effects are recorded at 4–5 h, 24 h, and 48 h (extended to 72/96 h if needed); non-feeders (consuming <80% of aver- age) are excluded from endpoint calculations.

Key Endpoints: LD50 (median lethal dose) and NOED (no observed effect dose) are calculated based on actual chemical intake per bumblebee, using statistical models and corrections for control mortality.

Summary

Introduction

This document outlines the OECD Guideline 247 for conducting laboratory tests to assess the acute oral toxicity of chemicals, particularly pesticides, on adult worker bumblebees.

Key Insights and Themes

- Test Purpose is to determine the acute oral toxicity (LD50) of chemicals to adult worker bumblebees, supporting pollinator risk assessments and regulatory requirements.

- Test Species primarily include Bombus terrestris and Bombus impatiens, though the method may be applicable to other bumblebee species.

- Exposure Routes considered are oral ingestion of contaminated food, simulating real-world chemical exposure for pollinators.

- Test Design involves exposing individually housed adult worker bumblebees to a single dose of a test chemical via a 50% sucrose solution for up to 4 hours, followed by observation for at least 48 hours (up to 96 hours if needed).

- Control Groups include water control, solvent control (if applicable), and a toxic reference substance (e.g., dimethoate) to verify test sensitivity and reliability.

- Colony Source requires bumblebee workers collected from mediumsized colonies with brood and a laying queen, excluding very small, large, newly emerged, male, or queen bees.

- Randomization and Weighing ensures unbiased allocation of bumblebees to treatment groups and accurate dose calculations.

- Acclimatization of bumblebees for at least 8 hours in single housing with untreated sucrose solution is mandatory to discard unhealthy individuals before testing.

- Starvation Period of 2–4 hours before dosing ensures full consumption of the treated diet within a maximum of 4 hours.

- Dose Preparation involves dissolving the test chemical in sucrose solution, using water or an organic solvent as appropriate, and preparing appropriate control solutions.

- Analytical Verification of test solution concentrations is required at least once for the lowest and highest doses, and for new chemical batches.

- Replicates and Dosing typically require five doses in a geometric series with at least 30 bumblebees per dose group, and at least three colonies to avoid colony effects.

- Non-feeders (bumblebees consuming <80% of mean food intake) are excluded from endpoint calculations to ensure accurate toxicity values.

- Test Conditions include constant darkness, 25 ± 2 °C temperature, and 60 ± 20% relative humidity, with continuous monitoring.

- Observations include daily mortality and sublethal effects, with specific behavioral criteria for affected and moribund bees.

- Limit Test may be conducted for low-toxicity chemicals using 50 replicates per group and a high dose, proceeding to full dose-response if significant mortality occurs.

- Data Analysis requires statistical methods (e.g., Probit analysis) to determine LD50 with 95% confidence limits, correction for control mortality, and reporting of NOED if possible.

- Reporting Requirements specify detailed documentation of test chemicals, bumblebee sources, conditions, methods, raw data, and deviations from guidelines.

Conclusion

The guideline establishes a standardized, robust procedure for assessing the acute oral toxicity of chemicals to bumblebees, supporting pollinator risk assessment and regulatory decisions

SOURCE DOCUMENT

Reference : EFSA Journal 2013;11(7):3295

Date: 2013

The EFSA Guidance Document establishes a tiered framework to assess risks of plant protection products to bees (Apis mellifera, Bombus spp., solitary bees) under Regulation (EC) 1107/2009, defining Specific Protection Goals and trigger values. It prescribes screening and progressively refined exposure and effect assessments (HQ/ETR), covering spray, seed and granule applications, metabolites, guttation and water routes, plus laboratory, semi‑field and field study protocols.

The Risk Assessment (RA) explicitly covers honey bees (Apis mellifera), bumble bees (Bombus spp.) and solitary bees and it uses a tiered approach: a simple, cost-effective first tier to screen out negligible-risk uses, with refinement and higher-tier semi-field/field studies when triggers are exceeded.

The RA combines exposure assessment (deriving predicted environmental concentrations, PECs) with effect assessment against specific protection goals (SPGs); first-tier decisions use trigger comparisons.

Targets include colony survival/development and related attributes; effect limits include ≤ 7% reduction in colony size and constraints on increased forager mortality (e.g., 1.5× for 6 days; 2× for 3 days; 3× for 2 days).

First-tier decision metrics

The approach uses HQ (hazard quotient) and ETR (exposure toxicity ratio) triggers comparing PEC-based exposure to toxicity endpoints (e.g., adult LD50, chronic 10‑day endpoint, larval NOEL), with bespoke trigger values aligned to SPGs.

Exposure routes/scenarios

In the RA multiple routes are assessed including contact from spray/dust drift and oral exposure via nectar/pollen from treated crop, weeds, field margins, adjacent crops, and potential following-year exposure; also addresses contaminated water (including guttation, surface water, puddles), metabolites, and accumulative effects.

Data/protocol gaps & future needs

The document identifies a lack of validated test protocols for bumble bees and solitary bees and proposes interim protocols in appendices, and notes future need for fully validated methods.

Overall, the document concludes that bee protection should be ensured through a tiered, SPG-driven risk assessment that uses conservative screening triggers and progressively refined exposure/effects evidence (plus mitigation where needed) to determine whether pesticide uses can avoid unacceptable harm to honey bees, bumble bees, and solitary bees.

SOURCE DOCUMENT

Date: 10/06/2011

Commission Regulation (EU) No 546/2011 sets out the uniform principles that EU Member States must apply when evaluating and authorising plant protection products. It implements Regulation (EC) No 1107/2009 and carries over, essentially unchanged, the rules previously held in Annex VI of Directive 91/414/EEC. Its purpose is to harmonise not only how national authorities assess an application dossier, but also the specific thresholds that determine whether a product can be placed on the market — ensuring that decisions across the EU reach a consistently high level of protection for human and animal health and for the environment.

The regulation is built in two parts. Part I covers chemical plant protection products; Part II covers products based on micro-organisms, which follow a distinct logic because micro-organisms can replicate, persist and be infective rather than merely toxic. Each part is structured the same way: an evaluation section describing how the competent authority examines the submitted data, followed by a decision-making section setting out the pass-or-fail criteria and the conditions attached to any authorisation.

Across both parts, the assessment spans the same core themes — efficacy, absence of unacceptable effects on treated and neighbouring crops, impact on human and animal health from both the product and its residues, environmental fate in soil, water and air, effects on non-target species, analytical methods, and physical-chemical properties. A recurring feature is the tiered approach: an initial realistic assessment, followed by a worst-case re-evaluation, with many refusal thresholds able to be overturned by a higher-tier risk assessment that demonstrates no unacceptable effect under field conditions.

For chemical products under Part I, the decision-making thresholds are largely numerical. To take a few examples: an authorisation cannot be granted if operator exposure exceeds the Acceptable Operator Exposure Level, or if the best estimate of dietary exposure exceeds the Acceptable Daily Intake. On the environmental side, a substance that persists in soil beyond defined limits, or whose concentration in groundwater would exceed the applicable limit, is refused. For non-target species, fixed trigger values apply — such as the toxicity-exposure ratios for birds, fish and earthworms, or the hazard quotient for honeybees — each of which blocks authorisation unless a suitable risk assessment shows the risk is acceptable in practice.

Part II applies a comparable framework to microbial products, but with an important difference: alongside the toxicity-based triggers inherited from Part I, pathogenicity and infectivity are assessed as standalone grounds for refusal. For example, no authorisation may be granted if the micro-organism is pathogenic to humans, non-target animals, bees or earthworms, or if it could colonise or cause adverse effects in people under realistic worst-case use. Two further refusal grounds have no equivalent in Part I: an authorisation is blocked where the micro-organism could interfere with the effectiveness of an antimicrobial agent used in human or veterinary medicine, and where the transfer of genetic material to other organisms could lead to adverse health or environmental effects.

In short, 546/2011 is the decision-making backbone that competent authorities such as France's ANSES apply when authorising a plant protection product. It remains legally in force, though it should be read alongside the more recent guidance and amendments that have evolved since 2011 — particularly in areas such as bee risk assessment, where scientific practice has moved beyond the original provisions.

SOURCE DOCUMENT

Reference : SANCO/10329/2002 rev 2 final

Date: 17 October 2002

Purpose & Scope

This guidance document supports Rapporteurs, Member States, notifiers and applicants in interpreting the terrestrial ecotoxicology sections of Annexes II and III of Directive 91/414/EEC, promoting consistency and transparency in risk assessment for Annex I active substance inclusion.

General Principles

Risk assessment uses toxicity/exposure ratios (TER) for vertebrates and earthworms, and hazard quotients (HQ) for bees (trigger HQ < 50) and non-target arthropods (trigger HQ < 2). A tiered approach applies throughout: standard laboratory tests first, followed by refined assessments and higher-tier (semi-)field studies where needed. Persistent substances (DT90f > 365 d or DT50f > 3 months) require heightened scrutiny. Metabolites formed at ≥10% of applied dose (major metabolites) must be assessed; minor metabolites (<10%) are generally covered if the parent compound is safe.

Terrestrial Vertebrates

Acute oral, short-term dietary and reproductive toxicity studies are required. Avian reproductive studies are triggered by use during breeding season or for persistent/bioaccumulative substances. TERa trigger: ≥10; TERlt trigger: ≥5. Regurgitation in acute tests must be evaluated and may require re-testing with non-regurgitating species for high-risk uses (e.g. seed treatments).

Bees

Acute oral and contact toxicity tests are required where honeybee exposure is likely. The HQ (application rate / LD50) must be <50 for both routes; if exceeded, higher-tier cage/tunnel/field studies are required. For systemic/seed-applied products, realistic residue concentrations in nectar and pollen must be considered. Risk mitigation includes restricting application timing, excluding use during flowering, or confining use to inaccessible glasshouses.

Non-target Arthropods (ESCORT 2 approach)

Tier 1: glass-plate rate-response studies with Aphidius rhopalosiphi and Typhlodromus pyri to derive LR50 values. In-field HQ = (application rate × MAF) / LR50; off-field HQ applies additional drift and correction factors (default ×10). If HQ ≥2 for either species, higher-tier extended laboratory, aged-residue, semi-field or field studies are required. Recovery within one year must be demonstrable.

Soil Organisms

Acute earthworm toxicity (OECD 207) is always required where soil contamination is possible. Reproduction testing (ISO 11268-2) is triggered by DT90f > 100 d and/or ≥3 applications. TERa trigger: ≥10; TERlt trigger: ≥5. For persistent substances (DT90f 100–365 d), a Collembola/mite reproduction test is required if standard arthropod HQ >2; a litter-bag field decomposition test is required if DT90f >365 d or if soil microorganism effects exceed 25% after 100 days. Soil nitrification and carbon mineralisation tests (OECD 216/217) are always required.

Non-target Plants

A tiered approach applies. Tier 1 uses existing screening data (≥6 species; >50% effect at maximum rate triggers Tier 2). Tier 2 requires dose-response bioassays on 6–10 species; a deterministic TER >5 or probabilistic approach (ED50 for <5% of species below maximum predicted exposure) indicates acceptable risk. Tier 3 field/semi-field studies apply where Tier 2 indicates unacceptable risk. Key exposure route is spray drift, quantified using BBA drift tables at 1 m (field crops) or 3 m (orchards/vineyards).

Risk Mitigation Options

Options include: reduced application rate or frequency, timing restrictions (e.g. evening application, outside flowering), buffer zones, drift-reducing equipment, unsprayed headlands, and glasshouse-only restrictions. Risk mitigation measures must be realistic; unrealistic restrictions to circumvent higher-tier testing are not acceptable for Annex I listing purposes.

SOURCE DOCUMENT

Reference : EFSA Journal 2022;20(1):7032

Date: 30 November 2021

Supersedes the 2014 guidance (published April 2015). Mandatory implementation date to be set by the European Commission. An annexed online calculator implements the methodology.

Purpose & Scope

The guidance assists risk assessors and applicants in quantifying non-dietary, systemic exposure of the four OWRB groups as part of plant protection product (PPP) risk assessment under Regulation (EC) No 1107/2009. It applies to all exposure scenarios that can be expected under Good Agricultural Practices. Standardised methods now cover both outdoor and greenhouse uses; scenarios outside these standardised categories require an ad hoc approach judged most appropriate by the assessor.

Core Principles

Routine risk assessment for individual PPPs continues to rely on deterministic methods within a tiered framework, and an acute risk assessment is introduced where a PPP is acutely toxic, in addition to the longer-term assessment. Exposure estimates are normally based on the 95th percentile of the relevant dataset for acute assessments and on the 75th percentile for longer-term assessments. Where two or more active substances are present in a product, dose addition is assumed by default; a different toxicological profile must be justified in the assessment report if this default is not applied.

Overall approach

Assessment proceeds in three steps: first, identifying which risk assessments are required; second, applying standardised first-tier methods wherever the scenario is covered; and third, moving to a higher-tier or ad hoc assessment where no standardised method exists, or where a more realistic estimate can be justified. A higher-tier method should replace a standard first-tier one only where there are good grounds to expect a more reliable and realistic result for the proposed uses.

What the 2021 update introduced

The most significant addition is a full set of greenhouse scenarios for operators, workers and residents/bystanders, built on the BfR model. Crop parameters were revised across dislodgeable foliar residue (DFR), dissipation rate (DT50) and transfer coefficients (TC), including new TC values for bolting sugar beet and peach harvesting. Human default values — body weights, inhalation rates, body-part surface areas and PPE assumptions — were updated for harmonisation with EU regulations and EFSA guidance, notably the 2017 dermal absorption guidance. The online calculator was rebuilt to handle multiple active substances in one product, calculate safe re-entry intervals, apply revised crop groupings, account for soil-borne residue and generate a detailed report. New recommendations were added for the design, conduct and interpretation of higher-tier field studies.

Known deficiencies and open data gaps

The update is a substantial step toward EU-level harmonisation, but several gaps remain and are expected to be addressed in future revisions as raw data become available. The most relevant for practical dossier work are:

No acute risk assessment method exists for workers — data remain insufficient, and this is flagged as a deficiency.

Several operator scenarios are still uncovered: seed treatment and handling of treated seed, post-harvest, single-plant and paintbrush application, and home/allotment garden uses.

Further TC, DFR and DT50 data are needed, including for crop-to-crop and formulation extrapolation and for greenhouse re-entry inhalation.

Resident and bystander estimates need more data on drift from high crops, air concentrations, dust from treated-seed sowing, and age-specific human parameters.

Oral (hand-to-mouth) secondary exposure, aggregate exposure across products, and the statistics of small higher-tier datasets (n ≈ 10) all require further work.

Risk-mitigation credits for PPE and technical equipment (closed transfer systems, drift-reducing technology) need more real-condition data to be supported.

Practical note

EFSA accepts only raw data and original study reports — including for any models submitted — on transparency and precautionary grounds. This is worth flagging early to clients who intend to rely on literature-only DFR or DT50 values, since such data may not be admissible without the underlying reports.

SOURCE DOCUMENT

Reference : EFSA Journal 2014;12(10):3874

Date: 24.4.2025

Purpose & Scope

The Guidance supports risk assessors and applicants in quantifying non-dietary, systemic exposure to plant protection products under Regulation (EC) No 1107/2009. It replaces the fragmented national approaches (UK POEM, German model, etc.) with a more harmonised, deterministic, tiered methodology, and comes with an annexed exposure calculator (Appendix E). It isn't legally binding, but any departure needs sound scientific justification.

The four exposed groups are defined distinctly: operators (mixing/loading, application, cleaning), workers (re-entry into treated crops), bystanders (incidental, short-term/acute exposure adjacent to application), and residents (living/working/schooling nearby, up to 24 h/day, longer-term). A key logic point: for acutely toxic products, the bystander acute assessment covers residents; for non-acutely-toxic products, the resident longer-term assessment covers bystanders (Table 2).

Tiered approach: Step 1 identify which assessments are needed; Step 2 apply standardised first-tier methods; Step 3 use ad hoc methods where no standard exists or where they're more realistic; Step 4 higher-tier (e.g. probabilistic). Acute assessments default to the 95th percentile, longer-term to the 75th percentile.

Default values include adult bw 60 kg / child 10 kg, inhalation 100% absorbed, breathing rates by age (Tables 3–4), area treated per day by crop and equipment (Table 5), exposure durations, and PPE penetration factors (Table 7 — e.g. gloves 10% for liquids, certified coverall 5%).

Methods by group:

- Operators — now based on the AOEM (Großkopf 2012), replacing older models, with mixing/loading and application scenarios at 75th (Table 8) and 95th percentiles (Table 9); plus granule models from PHED (Tables 10–11).

- Workers — dermal exposure = DFR × TC × task duration, with a conservative default DFR₀ of 3 µg/cm²/kg a.s./ha, MAF for multiple applications (default 30-day half-life, Table 12), and crop-specific transfer coefficients (Table 13).

- Residents/bystanders — four pathways (spray drift, vapour, surface deposits, entry into treated crops), using the BREAM calculator for arable crops and Lloyd et al. (1987) for orchards/vines. Residents sum the mean values across pathways; bystanders use 95th percentiles but keep pathways separate. Includes specific hand-to-mouth and object-to-mouth equations for young children.

Conclusions and gaps: EFSA frames it as a major harmonisation step but flags substantial remaining data gaps — seed treatment, greenhouse and amateur scenarios, worker acute assessment (unreliable TC/DFR data), resident/bystander drift in high crops, vapour data, dust drift from treated seed, and the notably dropped AAOEL concept (the WoG removed the Acute Acceptable Operator Exposure Level for lack of an agreed derivation methodology). So while the guidance is a step forward, the following gaps are also highlighted:

Operator: seed treatment, greenhouse, home/allotment garden scenarios "are not covered by the Guidance."

Workers: "Available data are not reliable enough to proceed with the acute exposure assessment (in particular with regard to the TC and DFR values)" — this is also why Table 2 carries footnote (a) for workers: an acute assessment is in principle needed but insufficient data exist to perform it.

Residents/bystanders: explicit recommendations to collect data on drift after application in high crops, on daily air concentrations (vapour), and on dust drift from sowing treated seed ("no reference is made... because of a lack of data").

AAOEL: the WoG confirms it "decided to remove the concept from the final version," citing the comments received and "the lack of an appropriate methodology to derive such a reference value."

SOURCE

Date: 15.01.2026

Purpose and scope

- Provides a standardised, flowchart-driven framework for Member States assessing Article 53 emergency authorisation requests, making the existing SANCO/10087/2013 rev.1 guidance more explicit and actionable.

- Aims to align emergency use with the EU Biodiversity and Farm to Fork strategies, prioritise sustainable alternatives, and push transition toward regular authorisation.

- Only covers agronomic/plant-health considerations. Consumer safety and human/animal/environmental risk assessment are explicitly out of scope.

Core evaluation logic

The methodology hinges on identifying two things up front, which determine the flowchart used:

1 : Approval/hazard status of the active substance, in ascending order of scrutiny required: approved low-risk → approved (other than low-risk) → non-approved. Non-approved substances demand field-trial evidence; approved ones can often rely on expert judgement. A "pending" substance can be treated as approved if EU evaluation is advanced with no concerns raised.

2 : Pest status: common pest vs. regulated pest (under Reg. 2016/2031). Regulated pests get a streamlined path (Chart B), skipping steps typical for common pests.

Four evaluation charts (A–D) route each case; a separate "Necessity" chart is triggered when other PPPs already exist for the pest.

Key principles

- Necessity clause: if authorised alternatives exist, emergency use is justified only for resistance management (reactive, not proactive), superior/more consistent efficacy, or protecting an established IPM programme.

- Alternative control methods (chemical and non-chemical, including IPM) are scored on effectiveness (Levels 1–4) and feasibility (Levels 1–3). Only effectiveness Level 4 + feasibility Level 3 counts as a viable eligible alternative (feasibility takes the lowest score across scientific/technical/economic/agronomic/regulatory aspects). Time-to-effectiveness and prerequisites can modify the decision (Table 9 cases). Eligibility must rest on real-world evidence, never theoretical combinations. Assessment must be done at national level.

- Repeated authorisations require a structured, time-bound action plan toward a permanent solution, generally capped at five years.

- Concurrent applications for the same emergency are compared, favouring approved a.s., higher efficacy, better (eco)tox profile, and lower resistance risk. Usually one PPP suffices.

Conditions and restrictions

- Legal maximum of 120 days, but shorter is encouraged; spatial/temporal restrictions and mode-of-application limits should be applied where justified.

- Authorities may mandate non-chemical methods alongside the PPP, request a list of other pests controlled, and require post-authorisation monitoring (optional).

Supporting materials

An EU-wide inventory of alternatives is published on Zenodo; Annexes provide public-consultation results and three worked fictitious examples (Aleurocanthus spiniferus, Delottococcus aberiae, Drosophila suzukii).

SOURCE DOCUMENT