Open AccessEvaluation of confirmatory data following the Article 12 MRL review for imazamox
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.2019.5584
Subject(s) - library science , computer science
The applicant BASF SE submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified for imazamox in the framework of the maximum residue level ( MRL ) review under Article 12 of Regulation ( EC ) No 396/2005 as not available. To address the data gaps, the applicant submitted new residue trials on rice. Since the number of trials was not sufficient, the data gap was considered only partially addressed. The remaining data gaps related to metabolism studies and analytical enforcement methods have been addressed in the framework of the renewal of the approval for imazamox. New enforcement and risk assessment residue definitions for plant commodities were derived and the toxicological reference values for imazamox were revised. The previous consumer risk assessment was updated using the residue data submitted on rice and the new revised toxicological reference values. No consumer intake concerns were identified. The current reasoned opinion is intended to give risk managers the necessary information to take a decision on the amendment of the tentative MRL s established in the EU MRL legislation. Furthermore, EFSA recommends to review all existing EU MRL s for imazamox, considering the new residue definitions derived in the framework of the peer review.