Biocides | Services

Active substances

Dossiers in support of inclusion in Annex I of Directive 98/8/EC:

For inclusion into Annex I of Directive 98/8/EC of both new and existing active substances, a comprehensive dossier has to be submitted to EU competent authorities. 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, …
  • 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 Annex I inclusion 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 5 file
  • Submission of dossiers and defence in the review process
  • Performance of non-standard risk assessments (biostatistics, data management, etc.)

Dossiers for existing active substances had to be submitted until October 2008. If you need assistance in developing a dossier for a new active substance, please contact us.