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Evaluation of confirmatory data following the Article 12 MRL review for myclobutanil.

Authors :
Bellisai, Giulia
Bernasconi, Giovanni
Carrasco Cabrera, Luis
Castellan, Irene
del Aguila, Monica
Ferreira, Lucien
Santonja, German Giner
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Mioč, Andrea
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Ruocco, Silvia
Scarlato, Alessia Pia
Szot, Marta
Theobald, Anne
Tiramani, Manuela
Verani, Alessia
Source :
EFSA Journal; Apr2024, Vol. 22 Issue 4, p1-41, 41p
Publication Year :
2024

Abstract

The applicant Corteva Agriscience submitted a request to the competent national authority in Austria to evaluate the confirmatory data that were identified for myclobutanil in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gap related to the lack of information on the triazole derivative metabolites (TDMs), new residue trials analysing for TDMs were submitted on apples, grapes, strawberries, tomatoes and melons. Following the assessment of the submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for pome fruits, grapes, cucurbits with inedible peel, strawberries and tomatoes. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No information was provided to address the Article 12 confirmatory data referred to in Regulation (EU) 2020/770 for blackberries, gooseberries, bananas, aubergines/eggplants, lamb's lettuces/corn salads, beans (with pods), globe artichokes, hops, sugar beet roots and products of animal origin. For these commodities, the existing EU MRL could be lowered to the enforcement limit of quantification (LOQ). For kaki/Japanese persimmon and azararoles/mediterranean medlars, the existing EU MRL is set on the basis of Codex MRL in pome fruits. The applicant did not request maintaining a Codex MRL in these commodities, but should risk managers decide otherwise, the Article 12 data gap is considered addressed for kaki/Japanese persimmon while for azaroles/Mediterranean medlars, a risk management decision might be required. No consumer intake concerns were identified. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
18314732
Volume :
22
Issue :
4
Database :
Complementary Index
Journal :
EFSA Journal
Publication Type :
Academic Journal
Accession number :
176928078
Full Text :
https://doi.org/10.2903/j.efsa.2024.8746