All biocidal products, which are used to protect against harmful organisms like pests or bacteria, require an authorisation before they can be placed on the EU market, and the active substances contained in that biocidal product must be previously approved to ensure a high level of protection for humans and the environment.
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012), applicable from 1 September 2013 and repealing the Biocidal Products Directive (Directive 98/8/EC) aims to harmonise the market at Union level; simplify the approval of active substances and authorisation of biocidal products and promotes the reduction of animal testing by introducing mandatory data sharing obligations and encouraging the use of alternative testing methods.
The approval of active substances takes place at Union level under the remit of ECHA and the subsequent authorisation of the biocidal products at Member State level that can be extended to other Member States by mutual recognition. The new regulation also provides applicants with the possibility of a new type of authorisation at Union level (Union authorisation).
DERAC has previous experience in reviewing or developing environmental risk assessment for active substances registered for PTs 1, 2, 3, 4, 5, 6, 8, 11, 12, 14, 18 and 21 biocidal products.
DERAC understanding of environmental sciences, industrial processes and regulatory authorities expectations enables to make the best use of existing information, to ensure that testing programmes are appropriate and to provide convicing justifications to the authorities.
DERAC offers its main and specific skills in support of BPR compliance with many aspects of the BPR requirements.
As regulatory authorities (European Chemicals Bureau)
As an applicant for industry (manufacturer)