Imidacloprid was included in Annex I to Directive 91/414/EEC on 1 August 2009 by Commission Directive 2008/116/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011 and Commission Implementing Regulation (EU) No 485/2013.
In accordance with Article 21 of Regulation (EC) No 1107/2009 to review the approval of active substances in light of new scientific and technical knowledge and monitoring data, in January 2014 the European Commission requested the EFSA to perform an evaluation of imidacloprid and provide conclusions as regards the risk to aquatic organisms following consideration of a new study on the toxicity of imidacloprid on aquatic organisms.
The conclusions laid down in this report were reached on the basis of the evaluation of the existing studies that were submitted by the applicant in support of the original approval of imidacloprid, the recent study on the toxicity of imidacloprid on aquatic organisms together with its evaluation undertaken by the Netherlands. In addition, higher tier microcosm/mesocosm studies not available for the original approval of imidacloprid were submitted by the applicant and three other companies and were taken into account, as well as any other data that were judged to be relevant to the assessment. For the latter purpose, EFSA requested the applicant to conduct a systematic literature review in accordance with the EFSA Guidance on the submission of scientific peer-reviewed open literature (EFSA Journal 2011;9(2):2092). The EFSA guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters (EFSA Journal 2013;11(7):3290) was considered in the current evaluation.
Definitive Regulatory Acceptable Concentrations (RACs) to be used for the acute and chronic risk assessment for aquatic organisms could not be established on the basis of the available data. However, in the absence of further data, the provisional tier-2 RACs should be considered currently as the most suitable approach for addressing the risk to the most sensitive aquatic species. Overall, based on these provisional tier-2 RACs and by following a conservative approach, a high acute and chronic risk could not be excluded for the representative uses in apple and field tomato and a high chronic risk could not be excluded for the representative use in glasshouse tomato, while a low risk may be concluded for the representative use in sugar beet based on a weight of evidence approach. Overall, further data would be needed to draw a firm conclusion and/or to refine the risk assessment.