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Commission Regulation (EU) No 544/2011 (repealed)Show full title

Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)

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Aim of the tests

The soil degradation studies shall provide best possible estimates of the time taken for degradation of 50 % and 90 % (DT50lab and DT90lab), of the active substance, and of relevant metabolites, degradation and reaction products under laboratory conditions.

Aerobic degradation
Circumstances in which required

The rate of degradation in soil must always be reported, except where the nature and manner of use of plant protection products containing the active substance preclude soil contamination such as uses on stored products or wound healing treatments for trees.

Test conditions

The rate of aerobic degradation of the active substance in three soil types additional to that referred to in point 7.1.1.1.1 must be reported.

In order to investigate the influence of temperature on degradation, one additional study at 10 °C has to be performed on one of the soils used for the investigation of degradation at 20 °C until a validated EU calculation model for the extrapolation of degradation rates at low temperatures is available.

The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires.

Similar studies for three soil types must be reported for all relevant metabolites, degradation and reaction products which occur in soil and which at any time during the studies account for more than 10 % of the amount of active substance added, except where their DT50 values were able to be determined from the results of the degradation studies with the active substance.

Test guideline

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

Anaerobic degradation
Circumstances in which required

The rate of anaerobic degradation of the active substance must be reported where an anaerobic study has to be performed in accordance with point 7.1.1.1.2.

Test conditions

The rate of anaerobic degradation of the active substance must be carried out in the soil used in the anaerobic study performed in accordance with point 7.1.1.1.2.

The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires.

Similar studies for one soil must be reported for all relevant metobolites, degradation and reaction products which occur in soil and which at any time during the studies account for more than 10 % of the amount of active substance added, except where their DT50 values were able to be determined from the results of the degradation studies with the active substance.

Test guideline

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

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