Dossier Preparation and Risk Assessment
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 info@kerona.ie or contact the team on +353 1 849 5284.
In summary, we provide the following range of services for dossier preparation:
- Active substance and representative product dossiers for renewal of active substances under the AIR programmes including comprehensive literature searches according to the EFSA 2011 criteria and identification of endocrine disrupting properties according to the EFSA guidance (June, 2018)
- dRR dossiers (Part A, Part B, Part C for all sections) with summary, risk assessment and evaluation in the required format for:
- Zonal authorisation of a product (Article 33)
- Label extension (LEX) dossiers
- Product re-authorisation (Article 43)
- Generic registration (‘me-too’ approach, Article 34)
- Extension of authorisation for minor uses (Article 51)
- National addenda (e.g. consideration of spray drift, drain-flow and TMDI calculations for the UK)
- Preparation of all required risk assessments:
- Consumer (dietary risk assessment)
- Toxicology (operator, worker, bystander)
- Environmental fate and behaviour modelling as required, e.g.:
- FOCUS GW modelling (e.g. FOCUS PEARL 4.4.4, FOCUS PELMO)
- PECsw (FOCUSsw steps 1 – 4, TOXSWA, spray drift, drainflow)
- PEC soil
- Ecotoxicology (birds, mammals, aquatic and soil species, non-target arthropods and non-target plants)
- Biological assessment dossiers (BAD)
- Comparative assessment where the active substance is a candidate for substitution (CfS)
- Peer review of draft dossiers
- Screening of uses in GAP table for all risk assessments to identify passing/failing scenarios and options for refinement