Biocides | Services

Active substances

Approval of new active substances and renewal of substances under the Biocidal Products Regulation (EU) 528/2012. EBRC’s services comprise all activities necessary for a successful application:

  • Product-type specific initial completeness check of data sets
  • Identification of data gaps
  • Evaluation of the validity of existing studies
  • Strategy for closing data gaps, e.g. through comprehensive literature searches or conduct of new experimental studies
  • Planning, coordination and monitoring of experimental studies
  • Development of concepts for data waiving
  • Modelling of physicochemical, toxicological and environmental substance properties [(Q)SAR]
  • Evaluation of physicochemical hazards of active substances
  • Assessment of the basic effectiveness of active substances
  • Evaluation of the toxicological profile of active substances
  • Derivation of safe exposure levels for humans: e.g. A(O)EL, ADI, etc.
  • Evaluation of the environmental fate of active substances
  • Evaluation of the ecotoxicological profile of active substances
  • Derivation of PNECs (predicted no-effect concentrations of active substances)
  • Proposals for classification & labelling
  • Preparation of complete dossiers in support of EU listing of both new and existing active substances, according to product-type specific data requirements, including all relevant risk assessments, and preparation of a comprehensive IUCLID 6 file
  • Submission of dossiers and defence in the review process
  • Performance of non-standard risk assessments (biostatistics, data management, etc.)