Board for the Authorisation of Plant Protection Products and Biocides

Evaluation Manual version 2.1

April 2017

Product authorisation under the BPR

The Ctgb regularly publishes Evaluation Manuals, which are technical work instructions developed mainly for internal use. 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 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 as PDF-files in English. In these versions of the Evaluation Manual 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. You can use the index below to brows to the different chapters in the complete PDF-file.

General introduction

The general introduction provides background information on the Biocidal Products Regulation (BPR) for products based on active substances already approved as well as active substance approval, and the Dutch transitional law for products based on active substances that are still under review. This general introduction chapter explains the differences between both legislations and makes clear under which legislations products must be notified.

Evaluation manual European framework; published June 2017

  1. Introduction EU framework
  2. Physical-Chemical-Properties
  3. Efficacy
  4. Human Health
  5. Environment

In addition to the European evaluation framework there is a National framework. Requirements related to national specific elements are listed in this National framework.

Evaluation manual National framework; published April 2017

  1. Introduction NL Framework
  2. Mutual recognitions
  3. The application of national specific elements 
  4. National data requirements
  5. Approval
  6. Developments NL framework

Former Evaluation manual National framework was published October 2016​

When an active substance is approved under the BPR (EU) 528/2012 consequently the authorisation of biocidal products resigns under the legislative framework of the BPR.

To check which substance/product type combinations are included in the Review Programme and still under review, please refer to the ECHA website.

Product authorisation under transitional legislation

The BPR 528/2012 provides a number of transitional measures that allow a Member State to continue to apply its current system or practice, to facilitate the transition from the system of the Directive to that of the Regulation. Transitional measures concern (BPR, art. 89) the authorisation of biocidal products with an active substance in the European review programme that is not yet included on the Union list of Approved Active Substances or Annex I of the BPR and (BPR, art. 93) the authorisation of biocidal products not covered by the scope of the BPD 98/8/EC. Information and guidance on national authorisations under transitional legislation is provided in a separate Evaluation Manual:

Transitional Legislation framework; published June 2017

  1. Introduction Transitional Legislation Framework
  2. General data requirements
  3. Aspect specific data requirements
  4. Risk assessment
  5. Approval
  6. Developments Transitional legislation framework
  7. Appendices