Application Form B: Registration of a Biocide
An application under transitional legislation or an extension can be submitted until one year before the approval date of an active substance under the BPR for a regular authorisation, and until 90 days before the re-regsitration date for a minor change.
Form B must also be used for application of an extension / amendment of an authorisation (under transitional legislation).
Form B and all attachments (below) must be sumitted.
Appendix A - Active Substance
Information must be provide on: tests / studies justification confidential data reliability
Appendix B - Product
Information needs to be supplied on the product, especially on efficacy of the product and the physical-chemical properties of ...
Appendix C - Comparative Assessment
In some cases it is possible to use a comparative assessment. A comparative assessment is restricted to products based on ...
Appendix D - WGGA
The limits to the use of the product need to be carefully described in accordance with the instructions as given in enclosed ...
Appendix E - PGB - PUB
The description of the Practical Use of the Biocide should be submitted.
Instruction Appendix F - Composition Statement
A composition statement should be filled in to describe the formulation of the product. Along with the composition ...
Appendix G - Reference list
All documents you submit need to be mentioned, with reference to which part of the application the document is ...
Appendix H - Efficacy studies per biocidal use claim
This justification table has been designed to make it possible to check during the intake phase if all required studies are ...