Regulatory Consulting Services for Agrochemical Plant Protection Products in Europe

Registration Dossier Preparation & Submission
Product registration guidance for compliance with Plant Protection Product legislation. Preparation and submission of active substance and product dossiers for EU-wide, zonal and Member State registrations as applicable. Data gap analysis, literature search and evaluation. Preparation of data waivers. OECD format dossiers. Post Annex I (re-)registration.

Data Development / Study Monitoring
Identification of required studies to support registration objectives. Placement and monitoring of tests at contract research organizations. Review and interpretation of study results.

Environmental Fate and Ecotoxicology Data Review
Classification, packaging and labeling (CLP); soil, water, sediment and air DT50 values; adsorption/desorption and leaching potential; non-target organism toxicity endpoints and no observed effect concentrations (NOECs).

Toxicology Data Review
Classification, packaging and labeling (CPL). Acceptable operator exposure level (AOEL). Acceptable daily intake (ADI). Acute reference dose (ARfD).

Risk Assessment for Aquatic Organisms
Predicted environmental concentrations (PECs) in groundwater, surface water and sediment. Toxicity:exposure ratios (TERs).

Risk Assessment for Terrestrial Organisms
PECs in short/long grass, broadleaved plants, seeds, small and large insects, soil, worms, surface water, fish and other feed and drinking water sources. Estimated theoretical exposures (ETEs). TERs/hazard quotients (HQs).

Dietary Risk Assessment
Maximum residue levels (MRLs). Theoretical maximum daily intakes (TMDIs). National estimates of daily intake (NEDI). National estimates of short-term intake (NESTI).

Non-dietary Risk Assessment
UK predictive operator exposure model (POEM). German (BBA) model.