Commission Regulation (EU) No 544/2011 (repealed)Show full title

7.1.3. Mobility in the soil

7.1.3.1. Column leaching studies

Aim of the test

The test shall provide sufficient data to evaluate the mobility and leaching potential of the active substance and if possible of relevant metabolites, degradation and reaction products.

Circumstances in which required

Studies in four soils must be carried out where in the adsorption and desorption studies provided for under point 7.1.2 it is not possible to obtain reliable adsorption coefficient values.

Test guideline

SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.

7.1.3.2. Aged residue column leaching

Aim of the test

The test shall provide sufficient data to estimate the mobility and leaching potential of relevant metabolites, degradation and reaction products.

Circumstances in which required

The studies must be performed except:

• where the nature and manner of use of preparations containing the active substance, preclude soil contamination such as uses on stored products or wound healing treatments for trees, or

• where a separate study for the metabolite, degradation or reaction product in accordance with point 7.1.2 or point 7.1.3.1 was performed.

Test conditions

The period(s) of ageing shall be determined from inspection of the degradation patterns of active substance and metabolites to ensure that a relevant spectrum of metabolites is present at the time of leaching.

Test guideline

SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.

7.1.3.3. Lysimeter studies or field leaching studies

Aim of the tests

The test shall provide data on:

• the mobility in soil,

• the potential for leaching to ground water,

• the potential distribution in soil.

Circumstances in which required

Expert judgement will be necessary to decide whether lysimeter studies or field leaching studies shall be carried out, taking into account the results of degradation and other mobility studies and the predicted environmental concentrations in groundwater (PEC_GW), calculated in accordance with Section 9 of the Annex to Regulation (EU) No 545/2011. The type and conditions of the study to be conducted shall be discussed with the competent authorities.

Test conditions

Great care is necessary in design of both experimental installations and individual studies, to ensure that results obtained can be used for assessment purposes. Studies shall cover the realistic worst case situation, taking into account the soil type, climatic conditions, the application rate and the frequency and period of application.

Water percolating from soil columns must be analysed at suitable intervals, while residues in plant material must be determined at harvest. Residues in the soil profile in at least five layers must be determined on termination of experimental work. Intermediate sampling must be avoided, since removal of plants (except for harvesting in accordance with normal agricultural practice) and soil cross influences the leaching process.

Precipitation, soil and air temperatures have to be recorded at regular intervals (at least on a weekly base).

— Lysimeter studies

Test conditions

The minimal depth of the lysimeters shall be 100 cm; their maximal depth shall be 130 cm. The soil monolith must be undisturbed. Soil temperatures must be similar to those pertaining in the field. Where necessary, supplementary irrigation must be provided to ensure optimal plant growth and to ensure that the quantity of infiltration water is similar to that in the regions for which authorisation is sought. When during the study the soil has to be disturbed for agricultural reasons it must not be disturbed deeper than 25 cm.

— Field leaching studies

Test conditions

Information on the groundwater table in the experimental fields must be submitted. If soil cracking is observed during the study this must be fully described.

Great attention shall be given to the number and the location of water collection devices. The placement of these devices in the soil shall not result in preferential flow paths.

Test guideline

SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.