case studies
country specific registrations and a choice of format

Our client wanted to register a herbicide for use on arable crops in Greece. The parent compound degraded rapidly giving rise to a relevant metabolite. Initially we consulted with our regulatory affairs expert, Dr Andrew Craven, to identify the requirements set out by the Greek regulatory authorities. Enviresearch then prepared a standard PEC report using model scenarios appropriate for the member state in question.

One of the aquatic risk assessments failed at the first tier. Because the concentration of the test substance was maintained throughout the duration of the aquatic toxicity tests, we used time weighted average concentrations.

The risk assessment calculations were in accordance with directive 91/414/EC. We presented our findings in OECD dossier point formats:

•    MIII Section 5 point 9 – fate and behavior in environment
•    MIII Section 6 point 10 – ecotoxicological studies
•    NIII Chapter 5 and 6 – overall summary and assessment