The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection to humans and the environment.
The new text was adopted on 22 May 2012 and will be applicable from 1 September 2013, with a transitional period for certain provisions. It will repeal the Biocidal Products Directive (Directive 98/8/EC).
All biocidal products to be placed on the market require an authorisation, and the active substances contained in that biocidal product should be previously approved. The BPR intends to harmonise the market at Union level, simplify the authorisation and approval of active substances and introduce timelines for Member State evaluations, opinion-forming and decision-making. It also promotes reduction in animal testing by mandatory data sharing and encouraging the use of alternative testing methods.
As in the previous directive, the approval of active substances takes place at Union level and the subsequent authorisation of the biocidal products at Member State level. This authorisation can be extended to other Member States by mutual recognition. However, the new regulation also provides applicants with the possibility of a new type of authorisation at Union level (Union authorisation).
A dedicated IT platform, the Register for Biocidal Products (R4BP), will be used for submitting applications, exchanging data and information between the applicant, ECHA, Member State competent authorities and the European Commission. It will also document decisions and help to disseminate information to the public.