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

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

PMC · DOI: 10.2903/j.efsa.2025.9231 · EFSA Journal · 2025-02-19

## TL;DR

This paper evaluates confirmatory data for terbuthylazine, confirming maximum residue levels in some crops but not others, with no consumer risk identified.

## Contribution

The study confirms tentative maximum residue levels for terbuthylazine in specific crops and livestock, while identifying data gaps in others.

## Key findings

- Tentative MRLs for terbuthylazine are confirmed in sweet corn and sunflower seeds.
- Consumer risk assessment shows no concerns with current MRLs.
- Metabolism in ruminants remains partially unclear due to data shortcomings.

## 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.

## Linked entities

- **Chemicals:** terbuthylazine (PubChem CID 22206)

## Full-text entities

- **Species:** Bos taurus (bovine, species) [taxon 9913], Helianthus annuus (common sunflower, species) [taxon 4232]

## Full text

_Full body text omitted from this summary view._ Fetch the complete paper as Markdown: https://tomesphere.com/paper/PMC11836617/full.md

## Figures

16 figures with captions in the complete paper: https://tomesphere.com/paper/PMC11836617/full.md

## References

22 references — full list in the complete paper: https://tomesphere.com/paper/PMC11836617/full.md

---
Source: https://tomesphere.com/paper/PMC11836617