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

fludioxonil, confirmatory data, pesticide, MRL review, risk assessment
First published in the EFSA Journal
17. September 2019
7. August 2019
Reasoned Opinion


The applicant Syngenta submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The applicant provided residue trials on strawberries representative for an adjusted Good Agricultural Practice (GAP) and a new feeding study in ruminants. The data gaps identified in the MRL review were considered satisfactorily addressed, except for the southern adjusted GAP on strawberries. The new residue data confirm the existing tentative MRL for strawberries; EFSA proposed – based on the new feeding study in ruminants – amendments of the existing MRLs for certain animal products for further risk management consideration. EFSA updated the most recent consumer risk assessment for fludioxonil and concluded that the long‐term dietary intake is unlikely to present a risk to consumer health.

European Food Safety Authority
pesticides.mrl [at] efsa.europa.eu
EFSA Journal 2019;17(9):5812
Question Number
On request from
European Commission

Background documents