Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels in citrus fruits for imazalil

Abstract

The applicant Janssen Pharmaceutica N.V. submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for imazalil in the framework of the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005. In addition, a request for raising the MRL for citrus fruits was made. To address the data gaps additional information on the toxicity of the metabolites R014821, FK-722 and FK-284 and storage stability for imazalil and FK-772 in ruminant matrices were submitted. The data gaps implemented in the MRL legislation were considered satisfactorily addressed with the information submitted in this application and in a previous MRL application on courgettes. The available residue data support the intended post-harvest uses in citrus fruits and allow deriving an MRL proposal. The implementation of the Codex MRL for bananas and the maintenance of the existing tentative MRL for melons are proposed for risk management consideration. Based on the risk assessment results, noting that data on unit-to-unit variability of residues to refine the acute consumer risk assessment for citrus were provided, EFSA concluded that the short term and long-term intake of residues resulting from the uses of imazalil according to the intended agricultural practices is unlikely to present a risk to consumer health.