Active Substances Services

• 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.