New EU legislation (which applied from 1 September 2013) replaces the Biocidal Products Directive (98/8/EC). The Biocidal Products Regulation (BPR) (EU) 528/2012 is designed, like its predecessor, to harmonise the European market for biocidal products and their active substances. At the same time it aims to provide a high level of protection for humans, animals and the environment.
All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. The legislation requires the submission and evaluation of data on the active ingredient(s) and substances of concern, as well as the products themselves, including that relating to the toxicity to humans, and the toxicity and fate in the environment. The new regime is overseen by the European Chemicals Agency (ECHA), and submissions will be made in IUCLID 5 format.
For help in meeting the requirements of the new Biocidal Products Regulation, Contact us
The team at bibra has many years of experience in supporting companies with their biocide regulatory submissions, and working within IUCLID. We can help you through this complex legislative maze.