Evaluation of confirmatory data following the Article 12 MRL review for flonicamid

flonicamid, confirmatory data, pesticide, MRL review, risk assessment
First published in the EFSA Journal
13 May 2020
17 April 2020
Reasoned Opinion


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.

European Food Safety Authority
pesticides.mrl [at] efsa.europa.eu
EFSA Journal 2020;18(5):6117
Question Number
On request from
European Commission

Background documents