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 (EFSA conclusions, DARs/RARs or monographs, and EC review report) on properties of the active substance and the formulation
  • Equivalence assessment of the of technical materials 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
  • (Quantitative) Structure-activity relationship ((Q)SAR) modelling as non-testing method for the registration of substances:
    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.
    • According to basic data of the target substances/compounds and the specific endpoint, valid, robust and suitable (Q)SAR models will be selected by EBRC. We prefer the use of a combination of a mechanistic model and a model based on databases
    • A feasibility-screening is needed to check the validity of the (Q)SAR model and prediction and to fulfil the requirements for the applicability domain of the model compared to the chemical structure of the target chemical
    • An overall report will be provided including results in the formats as needed, e.g. (Q)SAR Model Reporting Format (QMRF) and (Q)SAR Prediction Reporting Format (QPRF)
  • Literature surveys
  • Electronic Dossier compilation (CADDY or IUCLID Format) and archiving services
  • Submission of electronic applications to German BVL
  • Maintenance of literature databases
  • Management of task forces and consortia