Evaluation Manual

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.

Evaluation Manual (latest version)

Version 2019-2, published February 2019

The Evaluation Manual describes the assessment framework used by the Ctgb for the assessment of applications for authorization of biocidal 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 biocidal products. The Evaluation Manual contains a general introduction and three parts:

  1. the European evaluation framework
  2. the national framework on requirements related to Dutch specific elements
  3. Product authorisations under transitional legislation

The manuals are periodically updated in accordance with new legislation and guidances. They are published as PDF-files and only available in English.

Evaluation Manual version 2019-2: the latest version

Evaluation Manual version 2019-2 is used for the assessment of application submitted from February 2019.

Evaluation Manual version 2019-1

Evaluation Manual version 2019-1 is used for the assessment of application submitted in January 2019.

Evaluation Manual version 2.1/2.2/2.3/w

Evaluation Manual version 2.1/2.2/2.3/w is used for the assessment of application submitted from November 2018 to January 2019.

Evaluation Manual version 2.1/2.2/2.3/2.5

Evaluation Manual version 2.1/2.2/2.3/2.5 is used for the assessment of application submitted from July to November 2018.

Evaluation Manual version 2.1/2.2/2.3/2.4

Evaluation Manual version 2.1/2.2/2.3/2.4 is used for the assessment of application submitted in May 2018.

Evaluation Manual version 2.1/2.2/2.3

Evaluation Manual version 2.1/2.2/2.3 is used for the assessment of application submitted from January to May 2018.

Evaluation Manual version 2.1/2.2

Evaluation Manual version 2.1/2.2 is used for the assessment of application submitted from November 2017 to December 2017.

Evaluation Manual version 2.1

Evaluation Manual version 2.1 is used for the assessment of application submitted from Juli 2017 to October 2017.

Evaluation Manual version 2.0/2.1-B

Evaluation Manual version 2.0/2.1-B is used for the assessment of application submitted in June 2017.

Evaluation Manual version 2.0/2.1-A

Evaluation Manual version 2.0/2.1-A is used for the assessment of application submitted from April 2017 to May 2017.

Evaluation Manual version 2.0

Evaluation Manual version 2.0 is used for the assessment of application submitted from October 2016 to March 2017.

Evaluation Manual version 1.0

For the assessment of application submitted before October 2016 Ctgb uses:

Version control

Version control Evaluation manual
Chapter Oct '16 Apr '17 Jun '17

Jul '17

Nov. '17 Jan '18 May'18 Jul '18

Nov '18

Jan '19

 Feb '19

General introduction

Version 2.0 Version 2.0 Version 2.0 Version 2.1 Version 2.2 Version 2.3 Version 2.4 Version2.5 Webbased Webbased Webbased
Active substance approval and product authorisation under BPR Version 2.0 Version 2.0 Version 2.1 Version 2.1 Version 2.2 Version 2.3 Version 2.3 Version 2.3 Version 2.3 Version 3.0 Version 3.0
NL specific part Version 2.0 Version 2.1 Version 2.1 Version 2.1 Version 2.1 Version 2.1 Version 2.1 Version 2.1 Version 2.1 Version 3.0 Version 3.1
NL Transitional legislation part Version 2.0 Version 2.0 Version 2.1 Version 2.1 Version 2.2 Version 2.2 Version 2.2 Version 2.2 Version 2.2 Version 3.0 Version 3.0
EM version V,2.0 V,2.0/2.1-A V.2.0/2.1-B V.2.1 V.2.1/2.2 V.2.1/2.2/2.3 V.2.1/2.2/2.3/2.4 V.2.1/2.2/2.3/2.5 V.2.1/2.2/2.3/w Version 2019-1 Version 2019-2