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

The applicant Corteva Agriscience International Sàrl submitted a request to the competent national authority in Sweden to evaluate the confirmatory data that were identified for isoxaben in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new analytical method for enforcement and its independent laboratory validation (ILV), plus additional studies on the magnitude of residues were submitted by the applicant. The outstanding data gaps were sufficiently addressed. The new information provided confirmed a no-residue situation in cotton seed and herbal infusions from flowers. The current MRL of 0.01 mg/kg for cotton seeds can therefore be confirmed. Since a more sensitive analytical enforcement method is now available, a lowering of the existing MRLs (0.05 mg/kg) for herbal infusions (flowers and roots) and hops to an limit of quantification (LOQ) of 0.01 mg/kg can be considered. The updated exposure calculations did not indicate a risk to consumers health.