Agrochemicals | Services

Further regulatory support

  • Initial completeness checks and identification of data gaps
  • Planning and monitoring of experimental studies
  • Critical assessment and comparison of applicants’ data with EU data (monographs, draft assessesment and EC review report) on properties of the active substance and the formulation
  • Assessment of the (toxicological and ecotoxicological) equivalence of active substances from different sources (SANCO/10597/2003)
  • Assessment on the extent of formulation changes (minor / major) and identification of data requirements
  • Justified proposals for classification and labelling of products
  • QSAR model calculations:
    EBRC maintains a large selection of validated QSAR models for the calculation of relevant physico-chemical and thermodynamic parameters of compounds. This service is useful for example in deciding whether a particular parameter requires experimental establishment or justification for non-submission, and for the prediction of explosive or oxidative properties of a compound/preparation.
  • Literature surveys
  • Electronic Dossier compilation (CADDY Format) and archiving services
  • Submission of electronical applications to German BVL
  • Maintenance of reference databases
  • Management of several task forces and consortia