Initial completeness checks and identification of data gaps
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
Exposure and risk assessments for each step of the notification or registration process
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
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.
