The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA’s scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for napropamide are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State the United Kingdom and presents EFSA’s scientific views and conclusions on the individual comments received.
Napropamide was included in Annex I to Directive 91/414/EEC on 1 January 2011 by Commission Directive 2010/83/EU, 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. It was a specific provision of the approval that the applicant was required to submit to the European Commission further studies confirming the surface water exposure assessment as regards the photolysis metabolites and the metabolite NOPA and information for the risk assessment of aquatic plants by 31 December 2012.
In accordance with the specific provision, the applicant, United Phosphorus, submitted an updated dossier in September 2013, which was evaluated by the designated rapporteur Member State (RMS), the United Kingdom, in the form of an addendum to the draft assessment report. In compliance with guidance document SANCO 5634/2009-rev.6.1, the RMS distributed the addendum to Member States, the applicant and EFSA for comments on 28 October 2015. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 28 January 2016. EFSA added its scientific views on the specific points raised during the commenting phase in column 4 of the reporting table.
The current report summarises the outcome of the consultation process organised by the RMS, the United Kingdom, and presents EFSA’s scientific views and conclusions on the individual comments received.
EFSA considers that the environmental exposure assessment provided in response to the European Commission’s request for further studies was inadequate and was not in accordance with agreed FOCUS guidance that is usually used as the basis for EU level assessment.
The submitted confirmatory data were not sufficient for addressing the risk assessment: a high risk to aquatic plants is still identified for napropamide (all scenarios for the three crops) and for the metabolites Dimer and MNF (screening based on the assumption that metabolites are 10-times more toxic than the parent). As no FOCUS step 4 calculations were provided for napropamide and its metabolites, no reliable conclusion could be drawn regarding the efficacy of mitigation measures. No new information was available to estimate the exposure of NOPA groundwater leachate reaching surface water. Consequently, no risk assessment could be performed.
The RMS considers that the confirmatory data requirements have been satisfactorily addressed and the remaining issues can be dealt with at Member State level.
Background documents are available in the Register of Questions