Evaluation Manuals

Evaluation Manual – version 2025-3 the latest version

The Evaluation Manual describes the assessment framework used by the Ctgb for the assessment of applications for authorization of plant protection products. Data requirements, risk assessment methodologies and approval criteria are discussed in the Evaluation Manual, which combines the collective context of laws and regulations, policies, and the guidance documents that describe the methodology for assessment of plant protection products and active substances. The Evaluation Manual presents the European evaluation framework, with an additional section on the national framework. Requirements related to Dutch specific elements are listed in the latter section.

The manuals are periodically updated in accordance with new legislation and guidances. They are published in English. In this version of the Evaluation Manual for each chapter a change log is added in which the adjustments in comparison to the previous version are disclosed. In the manuals reference is made to external sources by hyperlinks.

Version 2025-3, published April 2025

The EU Parts of the Evaluation Manual Chapters Environmental fate and behaviour: fate and behaviour in soil (persistence and leaching); fate and behaviour in water and fate and behaviour in air have been revised. From 1^st of September 2024 onwards the assessment of protected uses in greenhouses should follow the Interim working document on the interzonal core assessment of greenhouse uses - environmental fate that was published in March 2024. The RA required for the izCA of greenhouse uses is based on recommendations by the EFSA GD on protected crops (2014) and FOCUS Air (2008) using workable, agreed standard models and simple calculations. The proposed assessment is intended to cover all types of greenhouses and cultivation types. It should always be included in the izCA.

Chapter Environmental fate and behaviour: fate and behaviour in soil (persistence)

From 1^st of September 2024 onwards the assessment of protected uses in greenhouses should follow the Interim working document on the interzonal core assessment of greenhouse uses - environmental fate that was published in March 2024. According to the working document, the risk assessment for persistent substances should be performed for all cultivation systems or methods falling under ‘greenhouse uses’. This includes both soil-bound and soilless cultivation systems.

Chapter Environmental fate and behaviour: fate and behaviour in soil (leaching)

From 1^st of September 2024 onwards the assessment of protected uses in greenhouses should follow the Interim working document on the interzonal core assessment of greenhouse uses - environmental fate that was published in March 2024. The working document requires all nine standard FOCUS leaching scenarios to be considered for all active substances and metabolites. Additionally, the risk assessment should be performed for all cultivation systems or methods falling under ‘greenhouse uses’. This includes both soil-bound and soilless cultivation systems.

Chapter Environmental fate and behaviour: fate and behaviour in water

From 1^st of September 2024 onwards the assessment of protected uses in greenhouses should follow the Interim working document on the interzonal core assessment of greenhouse uses - environmental fate that was published in March 2024. According to the working document, two following distinct approaches for calculation of predicted environmental concentrations in surface water (PECsw) and sediment (PECsed) are both to be presented in the interzonal core dossier: 1) Standard tiered FOCUS SW approach considering drainage only for entry to surface water and sediment; 2) Simulation of ‘0.2 % dose rate-entry’ to surface water and sediment.

Chapter Environmental fate and behaviour: fate and behaviour in air

From 1^st of September 2024 onwards the assessment of protected uses in greenhouses should follow the Interim working document on the interzonal core assessment of greenhouse uses - environmental fate that was published in March 2024. For semi-volatile and volatile substances exposure via air is covered by the assessment of exposure to surface water and sediment (‘0.2% dose rate-entry’ calculations).

EU Evaluation framework and national parts:

1. General Introduction
2. Physical-Chemical properties and Analytical Methods
   In March 2024 Chapters 2 and 3 Anallytical Methods were combined.
3. Human Toxicology
4. Residues
5. Environmental Fate & Behaviour
6. Ecotoxicology
7. Efficacy

Previous versions of the Evaluation manual

• Version 2025-2, published March and valid till April
• Version 2025-1, published February and valid till March 2025
   
• Version 2024-4, published December 2024 and valid till February 2025.
• Version 2024-3, published August 1 and valid till December 2024.
• Version 2024-2, was published June 1, and valid till August 1.
• Version 2024-1, was published March 1 2023 and valid till June 1.
   
• Version 2023-4, was published in September 2024 and valid till March 1, 2023.
• Version 2023-3, was published July 1 and valid till September 20th.
• Version 2023-2, was published February 15th and valid till July 17th.
• Version 2023-1, was published in January 2023 and valid till February 15th 2023.
   
• Version 2022-4, was published in October 2022 and valid till January 2023.
• Version 2022-3, was published in July and valid till October2022.
• Version 2022-2, was published in April and valid till July 2022.
• Version 2022-1, was published in February and valid till April 2022.
   
• Version 2021-4, was published in August 2021 and valid till February 2022
• Version 2021-3, was published in July and valid till August 2021.
• Version 2021-2, was published in April and valid till July 2021.
• Version 2021-1, was published in January and valid till April 2021.
   
• Version 2020-5, was published in September 2020 and valid till January 2021.
• Version 2020-4, was published in July and valid till September.
• Version 2020-3, was published in June and valid till July.
• Version 2020-2, was published in April and valid till June.
• Version 2020-1, was published in January and valid till April 2020.
   
• Version 2019-4, was published in October 2019 and valid till January 2020. 
• Version 2019-3, was published in June and valid till October.
• Version 2019-2, was published in March and valid till May.
• Version 2019-1, was published and valid in February 2019.
   
• Version 2.1/2.2/2.3-E, was published in September 2018 and valid till February 2019.
• Version 2.1/2.2/2.3-D, was published in July and valid till September.
• Version 2.1/2.2/2.3-C, was published in May and valid till July.
• Version 2.1/2.2/2.3-B was published in April and valid till May.
• Version 2.1/2.2/2.3-A was published in February and valid till April.
• Version 2.1/2.2-D was published in January 2018 and valid till February.
• Version 2.1/2.2-C was published in November 2017 and valid till January 2018.
• Version 2.1/2.2-B was published in April and valid till November.
• Version 2.1/2.2-A was published in March and valid till April.
• Version 2.1 was published in October 2016 and valid till March 2017.
• For plant protection product applications submitted before October 2016, see version 2.0 of the manual.

Version Control 2025

Version control

EU Chapters	February	March	April
1. General introduction and Generic aspects
2. Physical chemical properties and Analytical Methods
In March 2024 Chapters 2 Physical chemical properties and Chapter Analytical Methods were combined.
3. Human toxicology; mammalian toxicology
3. Human toxicology; risk operator, worker, bystander and resident
4. Residues; residue dossier
4. Residues; risk consumer
5. Fate and behaviour in the environment; behaviour in soil; persistence			version 2.4
5. Fate and behaviour in the environment; behaviour in soil; leaching			version 2.9
5. Fate and behaviour in the environment; behaviour in surface water, sediment and sewage treatment plants (STP)			version 2.6
5. Fate and behaviour in the environment; behaviour in air			version 2.3
6. Ecotox General intro and overarching issues
6. Ecotoxicology; aquatic
6. Ecotoxicology; terrestrial; bees
6. Ecotoxicology; terrestrial; birds and mammals
6. Ecotoxicology; terrestrial; soil organisms
6. Ecotoxicology; terrestrial; non target arthropods and plants		version 3.0
7. Efficacy
NL Chapters
1. General introduction and Generic aspects
2. Physical chemical properties and Analytical Methods
In March 2024 Chapters 2 Physical chemical properties and Chapter Analytical Methods were combined.
3. Human toxicology; mammalian toxicology
3. Human toxicology; risk operator, worker and bystander
Appendix 1 to chapter 4 Human toxicology; Risk operator, worker and bystander; field use scenario list
4. Residues; residue dossier
4. Residues; risk consumer
5. Fate and behaviour in the environment; behaviour in soil; persistence
5. Fate and behaviour in the environment; behaviour in soil; leaching
5. Fate and behaviour in the environment; behaviour in surface water, sediment and sewage treatment plants (STP)	version 2.8
6. Fate and behaviour in the environment; behaviour in air
6. Ecotox General intro and overarching issues
6. Ecotoxicology; aquatic	version 2.4
6. Ecotoxicology; terrestrial; bees
6. Ecotoxicology; terrestrial; birds and mammals
6. Ecotoxicology; terrestrial; soil organisms
6. Ecotoxicology; terrestrial; non target arthropods and plants	version 2.9
7. Efficacy
7. Efficacy; crop definition DTG v 2.2; to be used from September 2019
7. Efficacy; crop definition DTG v 2.1; to be used till September 2019
7. Efficacy; guidance for updating to DTG vesion 2.2 (was-wordt lijst)
7. Efficacy; crop definition DTG 2.0
7. Efficacy; crop cycle list NL/Eng
7. Efficacy; DTW lijst v 4.0
7. Efficacy; DTW lijst v 3.0
7. Efficacy; DTW lijst v 2.0
7. Efficacy; spray volume list v 2.0
7. Efficacy; dipping fluid up take by flower bulbs
7. Efficacy; extrapolation document for ornamentals (in Dutch, translation follows a.s.a.p.)
7. Efficacy; extrapolation document for crops other then ornamentals (in Dutch, translation follows a.s.a.p.)
7. Efficacy; Sowing denities list (in Dutch)
Version number	2025-1	2025-2