Division 9.2.5 Estimation of concentrations in surface water and sediment

The surface water and sediment contamination routes shall be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions. Suitable estimations (calculations) of predicted environmental concentration in surface water PEC_SW and sediment PEC_SED of active substance shall be submitted, unless the applicant shows that contamination will not occur. PEC_SW and PEC_SED estimations shall relate to the maximum number and highest rates of application, at the shortest interval, for which authorisation is sought, and be relevant to ditches, ponds, and streams.

Relevant F1... surface water modelling tools shall be run. The factors which shall be considered in making PEC_SW and PEC_SED estimations relate to direct application to water, drift, run-off, discharge via drains and atmospheric deposition, and include processes such as volatilisation, adsorption, advection, hydrolysis, photolysis, biodegradation, sedimentation and re-suspension, and transfer between water and sediment. Initial maximum concentration following an application (global maximum), short-term and long-term PEC_SW calculations for relevant water bodies (time weighted averages) shall be provided. Corresponding initial maximum concentration following an application (global maximum), short-term and long-term PEC_SED calculations for relevant water bodies (time weighted averages) shall also be provided. These PEC values shall be provided for the active substance and all metabolites, breakdown and reaction products identified as a part of the residue definition for the risk assessment with respect to surface water and sediment. They shall be used to complete risk assessments, through a comparison with the endpoints derived from data from ecotoxicological studies.

Short-term and long-term PEC_SW and corresponding short-term and long-term PEC_SED calculations for relevant static water bodies (ponds; time weighted averages) and for relevant slow moving water bodies (ditches and streams; time weighted averages), shall be calculated with the aid of a moving time-window. Appropriate time windows with respect to data from ecotoxicological studies shall be applied.

The need to perform additional higher tier tests and the type and conditions of the tests to be performed shall be discussed with the F2... competent authorities.