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

The applicant Proplan Plant Protection Company submitted a request to the competent national authority in Austria (originally the United Kingdom) to evaluate the confirmatory data that were identified for paclobutrazol in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, two new metabolism studies performed on apples were submitted. In addition, two studies on the magnitude of residues in apples and pears providing data for triazole derivative metabolites were also submitted. The data gaps were considered satisfactorily addressed. The new information provided did not require a revision of the existing MRLs for pome fruits, apricots and peaches. An update of the risk assessment was performed for paclobutrazol and for the triazole derivative metabolites in light of the new data submitted and did not indicate any consumer intake concerns. [ABSTRACT FROM AUTHOR]