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Updated: Jul 17, 2025

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
Published on: August 22, 2017
Evaluation of confirmatory data following the Article 12 MRL review for flonicamid
Abstract:
The applicant ISK Biosciences Europe N.V, submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flonicamid in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. In order to address the data gaps, the applicant provided method validation data for hops, residue trials on cherries, plums, tomatoes and melons and referred to results from trials in cucumbers and storage stability and hydrolysis studies which have been assessed in previous EFSA outputs. The provided information was considered sufficient to address the confirmatory data gaps for hops, cherries, plums, tomatoes and aubergines, courgettes and cucurbits with inedible peel. EFSA updated the most recent consumer risk assessment for flonicamid and concluded that for the crops under assessment, the long-term and short-term dietary intake is unlikely to present a risk to consumer health.
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