The persistence and behaviour of plant protection products in open water (freshwater, estuarine and marine) shall be investigated unless it is possible to extrapolate from data obtained on the active substance and metabolites, breakdown and reaction products in accordance with the requirements set out in point 7.2.2.2 of Part A of the Annex to Regulation (EU) No 283/2013.
The test shall be reported unless the applicant shows that contamination of open water will not occur.
The rate of degradation and the pathway or pathways shall be reported either for a ‘pelagic’ test system or for a ‘suspended sediment’ system. Where relevant, additional test systems, which differ with respect to organic carbon content, texture or pH shall be used.
Results obtained shall be presented in the form of schematic drawings showing the pathways involved, and in the form of balance sheets which show the distribution of radio-label in water and, where relevant, sediment as a function of time, as between:
active substance;
CO2;
volatile compounds other than CO2;
individual identified transformation products;
extractable substances not identified; and
non-extractable residues in sediment.
The duration of the study shall not exceed 60 days unless the semi-continuous procedure with periodical renewal of the test suspension is applied. However, the period for the batch test may be extended to a maximum of 90 days, if the degradation of the test substance has started within the first 60 days.
The persistence and behaviour of plant protection products in aquatic systems shall be investigated unless it is possible to extrapolate from data obtained on the active substance and metabolites, breakdown and reaction products in accordance with the requirements set out in point 7.2.2.3 of Part A of the Annex to Regulation (EU) No 283/2013.
The test shall be reported unless the applicant shows that contamination of surface water will not occur.
The degradation pathway or pathways shall be reported for two water/sediment systems. The two sediments selected shall differ with respect to organic carbon content and texture, and where relevant, with respect to pH.
Results obtained shall be presented in the form of schematic drawings showing the pathways involved, and in the form of balance sheets which show the distribution of radio-label in water and sediment as a function of time, as between:
active substance;
CO2;
volatile compounds other than CO2;
individual identified transformation products;
extractable substances not identified; and
non-extractable residues in sediment.
The duration of the study shall be at least 100 days. It shall be longer where this is necessary to establish the degradation pathway and water/sediment distribution pattern of the active substance and its metabolites, breakdown and reaction products. If more than 90% of the active substance is degraded before the period of 100 days expires, the test duration may be shorter.
The degradation pattern of potentially relevant metabolites occurring within the water/sediment study shall be established by extension of the study for the active substance, when it is not possible to extrapolate from point 7.2.2.3 of Part A of the Annex to Regulation (EU) No 283/2013.
If photochemical degradation is of importance, a water/sediment study under influence of a light/dark regime may additionally be reported.
The type and conditions of the study to be performed shall be discussed with the national competent authorities.
The groundwater contamination routes shall be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions.
PECGW estimations shall relate to the maximum number and highest rates of application, at the shortest interval, and to the time of application for which authorisation is sought.
Relevant EU groundwater models shall be run. Where specific crops and circumstances are relevant, specific scenarios for typical use situations for the regions of use, for the respective crop or other situation of use shall be used. In case the behaviour in soil is dependent on soil parameters, respective parameters on degradation and adsorption in soil (DegT50 and Koc values) reflecting this dependency shall be used. If identified metabolites, breakdown or reaction products are found to occur in concentrations above 0,1 μg/L in the leachate, an assessment of their relevance shall be required.
Suitable estimations (calculations) of predicted environmental concentration in groundwater PECGW, of active substance shall be submitted, unless it is clearly evident from the data on degradation or adsorption, taking worst case values, that leaching would be negligible under the intended areas of use.
For all metabolites, breakdown or reaction products identified as a part of the residue definition for risk assessment with respect to groundwater (see point 7.4.1 of Part A of the Annex to Regulation (EU) No 283/2013) a PECGW calculation shall be required for assessing their relevance.
Where identified metabolites, breakdown or reaction products are found to occur in concentrations above 0,1 μg/L in the leachate, an assessment of their relevance shall be required.
The need to perform additional field tests and the type and conditions of the tests to be performed shall be discussed with the national competent authorities.
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 PECSW and sediment PECSED of active substance shall be submitted, unless the applicant shows that contamination will not occur. PECSW and PECSED 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 EU surface water modelling tools shall be run. The factors which shall be considered in making PECSW and PECSED 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 PECSW 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 PECSED 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 PECSW and corresponding short-term and long-term PECSED 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 national competent authorities.