Guidance on the Biocidal Products Regulation Version 4.0
Volume III Human Health - Assessment & Evaluation (Parts B+C)
The text has been revised as follows:
-To add a new section 6
-To revise section 3.4.2 to cross refer to this new section..
The Guidance on the Biocidal Products Regulation (BPR) is to be applied to applications for active substance approval and product authorisation as submitted from 1 September 2013, the date of application (DoA) of the Biocidal Product Regulation (the BPR).
This document describes the BPR obligations and how to fulfil them. The scientific guidance provides technical scientific advice on how to fulfil the information requirements set by the BPR (Part A), how to perform the risk assessment and the exposure assessment for the evaluation of the human health and environmental aspects and how to asses and evaluate the efficacy to establish the benefit arising from the use of biocidal products and that it is sufficiently effective (Parts B e C).
In addition to the BPR guidance, the Biocidal Products Directive (BPD) guidance and other related documents are still considered applicable for new submissions under the BPR in the areas where the BPR guidance is under preparation. Furthermore these documents are still valid in relation to the evaluation of applications for active substance approval or applications for product authorization submitted for the purposes of Directive 98/8/EC (BPD) which may be still under evaluation under the Biocidal Products Regulation (BPR)).
Documentazione di riferimento: