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

TL;DR

This paper evaluates confirmatory data for spinetoram following a regulatory review, focusing on analytical methods and residue trials.

Contribution

The paper confirms the adequacy of analytical methods for spinetoram except for extraction efficiency.

Findings

Confirmatory analytical methods were satisfactorily addressed for most matrices except extraction efficiency.

Residue trials for certain crops were provided, but no longer required due to expired approval period.

No revision of consumer risk assessment was needed.

Abstract

The applicant Corteva Agriscience International Sàrl submitted a request to the competent national authority in Croatia to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005. The applicant submitted, a confirmatory analytical method for high oil content and dry plant commodities, fat, liver, kidney and an enforcement analytical method for eggs (quantification and confirmation) and its ILV in the current application. Furthermore, residue trials for table and wine grapes, apples, pears and apricots were also provided. The data gaps on the analytical methods were considered as satisfactorily addressed for all relevant matrices except for the extraction efficiency which was not satisfactorily addressed. Since the approval period of spinetoram in the EU expired on 30 June 2024, the data gap on residue trials to support EU uses was not considered relevant anymore and a revision of the previous consumer risk assessment was not required.

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