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Abstract
Conducting groundwater monitoring studies in Europe for pesticide active substances and their metabolites in the context of Regulation (EC) 1107/2009
Highlights
In the European Union, placing a plant protection product on the market is regulated by Regulation (EC) No 1107/2009 and its associated implementing Regulations (i.e., 546/2011 on uniform principles, plus 283/2013 and 284/2013 on data requirements)
The decision-making in the uniform principles (Regulation 546/2011, Annex C 2.5.1.2, corrected by Regulation 2018/676) states that ‘‘no authorisation of a Plant Protection Product (PPP) should be granted if the concentration of the active substance or of relevant metabolites, degradation or reaction products in groundwater, may be expected to exceed the lower of (i) the maximum permissible concentration laid down by Directive 2006/118/EU according to Regulation (EC) Council Directive 98/83/EC or (ii) the maximum concentration laid down when approving the active substance with Regulation (EC) No 1107/2009 or the concentration corresponding to one tenth of the ADI laid down when the active substance was approved in accordance with Regulation (EC) No 1107/ 2009, unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded’’
While this chapter focuses on the strengths and weaknesses of various monitoring approaches, all monitoring in areas of product use can be helpful in determining whether the drinking water is being protected
Summary
In the European Union, placing a plant protection product on the market is regulated by Regulation (EC) No 1107/2009 and its associated implementing Regulations (i.e., 546/2011 on uniform principles, plus 283/2013 and 284/2013 on data requirements). Regulation 284/2013 requires estimating the concentration of the active substances and their metabolites in groundwater (PECgw), identified as part of the residue definition for risk assessment with respect to groundwater. The decision-making in the uniform principles (Regulation 546/2011, Annex C 2.5.1.2, corrected by Regulation 2018/676) states that ‘‘no authorisation of a Plant Protection Product (PPP) should be granted if the concentration of the active substance or of relevant metabolites, degradation or reaction products in groundwater, may be expected to exceed the lower of (i) the maximum permissible concentration laid down by Directive 2006/118/EC Council Directive 98/83/EC or (ii) the maximum concentration laid down when approving the active substance with Regulation (EC) No 1107/2009 or the concentration corresponding to one tenth of the ADI laid down when the active substance was approved in accordance with Regulation (EC) No 1107/ 2009, unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded’’. This requirement for information on rejected wells is probably more important in monitoring studies using existing wells that are selected from general monitoring networks, but could be useful for sites in which new wells are installed for the study
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