Evaluation Manuals

The Evaluation Manual is a technical instructions and gives information on assessment standards, assessment framework, and calculation models that are used to conduct the assessments.

Ctgb developed a special evaluation manual for Biopesticides; below you will find the EM for conventional PPP.

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 1st 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 1st 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 1st 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 1st 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 1st 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 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

Version control 2016 - 2023