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Commission Regulation (EU) No 283/2013Show full title
Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)
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- Revised 17/11/20141.04 MB
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7.1.4.2. Lysimeter studies
Lysimeter studies shall be performed, where necessary, to provide information on:
the mobility in soil,
the potential for leaching to ground water,
the potential distribution in soil.
Circumstances in which required
The decision whether lysimeter studies are to be carried out, as an experimental outdoor study in the framework of a tiered leaching assessment scheme shall take into account the results of degradation and other mobility studies and the predicted environmental concentrations in groundwater (PECGW), calculated in accordance with the provisions of Section 9 of Part A of the Annex to Regulation (EU) No 284/2013. The type and conditions of the study to be performed shall be discussed with the national competent authorities.
Test conditions
Studies shall cover the realistic worst case situation, and the duration necessary for observation of potential leaching, taking into account the soil type, climatic conditions, the application rate and the frequency and period of application.
Water percolating from soil columns shall be analysed at suitable intervals, while residues in plant material shall be determined at harvest. Residues in the soil profile in at least five layers shall be determined on termination of experimental work. Intermediate sampling shall be avoided, since removal of plants (except for harvesting in accordance with normal agricultural practice) and soil influence the leaching process.
Precipitation, soil and air temperatures shall be recorded at regular intervals, at least on a weekly base.
The depth of the lysimeters shall be at least 100 cm. The soil cores shall be undisturbed. Soil temperatures shall be similar to those pertaining in the field. Where necessary, supplementary irrigation shall be provided to ensure optimal plant growth and to ensure that the quantity of percolation 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 shall not be disturbed deeper than 25 cm.
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