OpenLegislation

Division Introduction

United Kingdom

Original text. Later amendments are not shown.

  1. 1Testing of the plant protection product shall be necessary where its toxicity cannot be predicted on the basis of data on the active substance. Where testing is necessary, the aim shall be to demonstrate whether the plant protection product, taking account of content of active substance, is more toxic than the active substance. Thus bridging studies or a limit test may be sufficient. However, where a plant protection product is more toxic than the active substance (expressed in comparable units), definitive testing shall be required. Possible effects on organisms/ecosystems shall be investigated, unless the applicant shows that exposure of the organisms or ecosystems does not occur.
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  4. 4Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 shall be used.
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  9. 9For those guidelines which allow for study to be designed to determine an effective concentration (ECx), the study shall be conducted to determine an EC10 and EC20 along with corresponding 95 % confidence intervals. If an ECx approach is used, a NOEC shall still be determined.
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  12. 12Division 12