The Kerona team has extensive experience in the preparation of dossiers to support plant protection products under Regulation (EC) No 1107/2009, both for active substances and formulated products. We manage the renewal of active substances under the AIR Programme, preparing full dossiers and risk assessments for all sections (toxicology, residues, environmental fate, ecotoxicology), addressing comments and queries from the RMS, EFSA and other MS as they arise. We also prepare full dossiers for zonal authorisation of plant protection products, including the core dossier and national addenda, Biological Assessment Dossier (BAD) and comparative assessment dossiers for candidates for substitution.
Our team has experience in a range of substances, including chemical, microbial, plant extracts and low-risk substances. We are equally happy to support our clients in completing only certain sections of the dossier where expertise is required, and in the review of finished dossier sections.
If you require assistance with dossier preparation and risk assessment, please send an email to firstname.lastname@example.org or contact the team on +353 1 849 5284.
In summary, we provide the following range of services for dossier preparation: