BPR - The new Biocidal Product Regulation

  • The old Biocidal Products Directive (98/8/EC; abbreviated as BPD) established a two-step process of approval:
    • evaluation of the active substance (AS) at the Union level, and 
    • biocidal product (BP) authorisation at Member State level
  • From 1 September 2013, the new European Biocidal Products Regulation (Regulation (EU) No 528/2012; abbreviated as BPR) will replace the current BPD.
  • Under the BPR, the two-tier procedure for regulating the placing of Biocidal Products on the market is continued, consisting of (1) AS approval and (2) BP authorisation
  • The BPR provides, next to the traditional national authorisation, the possibility that biocidal products are authorised at the Union level giving them direct access to the entire Union market. This new measure simplifies and streamlines the requirements for approving active substances and authorizing products. The new provisions will also reduce animal testing by making data sharing compulsory and encouraging a more flexible and intelligent approach to testing.
  • The European Chemicals Agency (ECHA) will provide a strong scientific and technical back-up to the Commission and the Member States under this new Regulation. In particular, ECHA will be responsible for the assessment of applications for the Union authorisation of biocidal products.
  • Key elements of the BPR in a nutshell:
    • Possibility for authorisation of biocidal products at the Union level;
    • Improving the functioning of national authorisations and mutual recognition procedures by introducing binding deadlines and strengthening the system of mutual recognition dispute settlement;
    • Reducing the number of animal tests by obligatory data sharing with respect to vertebrate animal studies;
    • Strengthening the rules on data waiving;
    • Extending the scope to cover “treated articles” and “in situ” generated active substances;
    • Harmonised fee structure which will harmonise the conditions and criteria for setting the fees in all Member States;
    • The European Chemicals Agency (ECHA) will be involved in the scientific work on biocides;
    • Companies placing biocidal products on the market will need to possess the data on the active substances within the biocidal products (for each BP authorisation dossier a Letter of Access (LoA) covering each active substance/product-type combination is required)