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 for humans and the environment. The text was adopted on 22 May 2012 and was applicable from 1 September 2013, with a transitional period for certain provisions.
BRF comprises significant changes
The Regulation replaces the Biocidal Products Directive and builds on many of the principles of the Directive, but also comprises significant changes:
- Simplified authorisation of less harmful products
- Articles treated with biocides are covered by the BPR
- Products may be authorised in the entire EU in one go
- An authorisation may be granted for a biocidal product family
- In-situ generated active substances are covered by the BPR
All biocidal products require an authorisation
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. There are, however, certain exceptions to this principle. For example, active substances under the review programme as well as biocidal products containing these active substances can be placed on the market while awaiting the final decision on the approval. Provisional product authorisations for new active substances that are still under assessment are also allowed on the market.
The BPR aims to harmonise the market at Union level; simplify the approval of active substances and authorisation of biocidal products; and introduce timelines for Member State evaluations, opinion-forming and decision-making. It also promotes the reduction of animal testing by introducing mandatory data sharing obligations and encouraging the use of alternative testing methods.
Approval of active substances takes place at Union level
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).
IT-tools for your application
A dedicated IT platform, the Register for Biocidal Products (R4BP 3), is be used for submitting applications, exchanging data and information between the applicant, ECHA, Member State competent authorities and the European Commission. Another IT tool, IUCLID 5, is used for preparing the applications.