Open AccessEvaluation of confirmatory data following the Article 12 MRL review for flutolanil
Author(s) -
Abdourahime Himdata,
Anastassiadou Maria,
Brancato Alba,
Brocca Daniela,
Carrasco Cabrera Luis,
De Lentdecker Chloe,
Ferreira Lucien,
Greco Luna,
Jarrah Samira,
Kardassi Dimitra,
Leuschner Renata,
Lostia Alfonso,
Lythgo Christopher,
Medina Paula,
Miron Ileana,
Molnar Tunde,
Nave Stefanie,
Pedersen Ragnor,
Raczyk Marianna,
Reich Hermine,
Ruocco Silvia,
Sacchi Angela,
Santos Miguel,
Stanek Alois,
Sturma Juergen,
Tarazona Jose,
Theobald Anne,
Vagenende Benedicte,
Verani Alessia,
VillamarBouza Laura
Publication year - 2019
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2019.5593
Subject(s) - risk assessment , microbiology and biotechnology , business , environmental health , medicine , biology , computer science , computer security
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.