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

• Main Authors: European Food Safety Authority (EFSA), Himdata Abdourahime, Maria Anastassiadou, Alba Brancato, Daniela Brocca, Luis Carrasco Cabrera, Chloe De Lentdecker, Lucien Ferreira, Luna Greco, Samira Jarrah, Dimitra Kardassi, Renata Leuschner, Alfonso Lostia, Christopher Lythgo, Paula Medina, Ileana Miron, Tunde Molnar, Stefanie Nave, Ragnor Pedersen, Marianna Raczyk, Hermine Reich, Silvia Ruocco, Angela Sacchi, Miguel Santos, Alois Stanek, Juergen Sturma, Jose Tarazona, Anne Theobald, Benedicte Vagenende, Alessia Verani, Laura Villamar‐Bouza
• Format: Article
• Language: English
• Published: Wiley 2019-02-01
• Series: EFSA Journal
• Subjects: flutolanil; confirmatory data; pesticide; MRL; consumer risk assessment
• Online Access: https://doi.org/10.2903/j.efsa.2019.5593

Abstract 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.