Renewal of Active Substance Approval
Active substance approvals have an expiry date (usually 10-years from the date of approval) and must be renewed at EU level. For substances that were approved but fulfil the Exclusion and/or Substitution “cut-off” criteria the expiry date for the substance is 5- and 7-years from the date of approval, respectively. Application for renewal of approval for each active substance must be made at least 550-days before the expiry of the approval by the company or companies. The application shall be submitted to the European Chemicals Agency (ECHA) via the Register for Biocidal Products (R4BP).
The ECHA Biocide Submission Manuals (BSM) assists applicants/industry with detailed and illustrative technical guidance. The manuals describe how to build IUCLID dossiers for the various Biocidal Product Regulation (BPR) applications and how to submit and manage those applications in the R4BP.
The process of active substance renewal proceeds either with a full or partial evaluation depending on the amount of data generated since the initial approval and the adoption of scientific and technical developments relating to the initial evaluation. The process of renewal proceeds with an evaluation and peer review similar to that of the initial active substance review.
For further queries about the Department of Agriculture, Food and the Marine acting as a RMS and undertaking an active substance renewal evaluation please contact us through the “Contact Us” section.