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

flutolanil, confirmatory data, pesticide, MRL, consumer risk assessment
First published in the EFSA Journal
4. Februar 2019
14. Januar 2019
Reasoned Opinion


The applicant Nihon Nohyaku Co. Ltd. submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flutolanil in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to new residue trials for globe artichokes and beans with pods and for storage stability data in products of animal origin were addressed. Further risk management consideration is required regarding the tentative MRL on peppers and on certain products of animal origin, since the data gaps identified in the MRL review were not addressed or only partially addressed. A new metabolism study on ruminants was provided which will be assessed in the framework of the renewal of the active substance flutolanil; formally, this data gap is considered to be addressed. EFSA updated the most recent consumer risk assessment for flutolanil and concluded that the long‐term dietary intake is unlikely to present a risk to consumer health. The conclusion reported in this reasoned opinion may need to be reconsidered in light of the outcome of the EU pesticides peer review.

European Food Safety Authority
pesticides.mrl [at] efsa.europa.eu
EFSA Journal 2018;17(2):5593
Question Number
On request from
European Commission

Background documents