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

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Spain to evaluate the confirmatory data that were identified for the active substance terbuthylazine in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Based on the information provided by the applicant and assessed by Spain, EFSA concludes that the tentative MRL is confirmed in sweet corn and sunflower seeds, but not in lupins/lupini beans and cotton seeds. Regarding livestock metabolism study, EFSA acknowledges that a new goat metabolism study was submitted. However, due to the shortcomings identified, the metabolism in ruminants cannot be fully depicted. Despite these deficiencies, it can be concluded that at the calculated maximum dietary burdens significant transfer of residues in bovine tissues and milk is not expected and therefore the tentative MRLs can be confirmed. The consumer risk assessment performed in the framework of the MRL review was updated using revision 3.1. of the PRIMo, considering the actual MRL values implemented in Regulation (EU) 2021/1795 and excluding the crops on which the uses are not supported by Article 12 confirmatory data (cotton seed and lupins/lupini beans). No consumer intake concerns were identified.

Authors

Publication Details

Journal
EFSA Journal
Published
2025-02-01
DOI
https://doi.org/10.2903/j.efsa.2025.9231
Primary Topic
Agricultural safety and regulations
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

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

Monica del Aguila, Giulia Bellisai, Manuela Tiramani, Marta Szot et al.
EFSA Journal
Agricultural safety and regulations
article

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

Monica del Aguila, Giulia Bellisai, Manuela Tiramani, Marta Szot, Elena Zioga, Luis Carrasco Cabrera, Irene Castellan, Lucien Ferreira, Renata G.K. Leuschner, Silvia Ruocco, Hermine Reich, Giovanni Bernasconi, Alessia Verani, Samira Jarrah, Anne Theobald, Stefanie Nave, Alessia Pia Scarlato, Luna Greco, Andrea Mioč, Andrea Simonati
article en

Abstract

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Spain to evaluate the confirmatory data that were identified for the active substance terbuthylazine in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Based on the information provided by the applicant and assessed by Spain, EFSA concludes that the tentative MRL is confirmed in sweet corn and sunflower seeds, but not in lupins/lupini beans and cotton seeds. Regarding livestock metabolism study, EFSA acknowledges that a new goat metabolism study was submitted. However, due to the shortcomings identified, the metabolism in ruminants cannot be fully depicted. Despite these deficiencies, it can be concluded that at the calculated maximum dietary burdens significant transfer of residues in bovine tissues and milk is not expected and therefore the tentative MRLs can be confirmed. The consumer risk assessment performed in the framework of the MRL review was updated using revision 3.1. of the PRIMo, considering the actual MRL values implemented in Regulation (EU) 2021/1795 and excluding the crops on which the uses are not supported by Article 12 confirmatory data (cotton seed and lupins/lupini beans). No consumer intake concerns were identified.

EFSA JournalVol. 23(2)
Good health and well-being
Openalex Percentile: Top 97%
Agricultural safety and regulations
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.