Previous version and overview changes

European evalution framework to version 3.4 was update.

Transitional legislation part was updated.

European evalution framework to version 3.5 was update.

European evalution framework to version 3.3 was update.

European evalution framework to version 3.2 was update.

European evalution framework to version 3.2 was update on:

• Efficacy: TAB and status of PT19 guidance update, several references;
• Implementation of CA-July19-Doc.4.1-rev.2 on the product authorization of in situ generated substances (APCP)
• Environment: iImplementation of the new Environment TAB ; notes on the applicability of TAB-entries are added as well as additional information on SimpleTreat;
• Human Health: general revision and textual aupdate

The general introduction of the Evaluation Manual Biocides is updated. Chapter 5.14 How to use and report (Q)SARs is added.

An overview of the changes in comparison with the previous versions is presented below.

Information on TAB and CA documents was updated.

Implementation of agreement from CG-30 on simplified procedures added to the European evaluation framework for active substance approval and product authorisation under BPR.

Update part 2 National framework on requirements related to Dutch specific elements.

In Chapter 5 of the introduction information is added on semiochemicals.

Update part 2 National framework on requirements related to Dutch specific elements.

All parts of the Evaluation manual are updated and published as version 3.0.

General introduction published as webpage instead of PDF-files.

Version 2.5

Added paragraph 5.11 Endocrine disruption.

Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009.

Version 2.4

Edited paragraph 5.10 Label claims

Addition of the way forward described in the minutes of the 70th CA-meeting (March 2017) on linking biocidal label claims and the product authorization.

Version 2.3

Edited paragraph 5.4

Addition of the Recommendation of the BPC Working Groups with regard to in situ generated active substances.

Version 2.2

Edited paragraph 5.8 Products based on carriers

Inclusion of CA-Nov16-Doc.4.3, Note for guidance on handling ‘carriers’ in the authorization of biocidal products.

Edited paragraph 5.9 Harmonised sentences SPC

Inclusion of ECHA documents with harmonised sentences for SPCs (‘Frequently used sentences in the SPC and translations’ and ‘SPC AVKs translations’)

Version 2.1

The subject on Biocidal products based on micro-organisms has been amended to emphasize that the “Guidance on the Biocidal Products Regulation Volume V, Guidance on Active Micro-organisms and Biocidal Products” describes the procedures following data requirements, hazard and exposure assessment and risk characterisation for all aspects as physical chemical, efficacy, human toxicology, and environment.

As the information presented in the introduction of the evaluation manuals is sufficient enough the subject is not described further anymore in the evaluation manual.

Edited paragraph 5.6 Disinfection By-Products

Update of the situation on Disinfection By-Products.

Version 2.0 Initial version of the document General Introduction Evaluation Manual Biocides.