Modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins

• Published in: EFSA journal Vol. 21; no. 4; pp. e07980 - n/a
• Main Authors: Bellisai, Giulia, Bernasconi, Giovanni, Brancato, Alba, Cabrera, Luis Carrasco, Castellan, Irene, Del Aguila, Monica, Ferreira, Lucien, Santonja, German Giner, Greco, Luna, Jarrah, Samira, Leuschner, Renata, Magrans, Jose Oriol, Miron, Ileana, Nave, Stefanie, Pedersen, Ragnor, Reich, Hermine, Robinson, Tobin, Ruocco, Silvia, Santos, Miguel, Scarlato, Alessia Pia, Theobald, Anne, Verani, Alessia
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.04.2023; John Wiley and Sons Inc; Wiley
• Subjects: Agricultural commodities; Agricultural practices; Cattle; Chromatography; Commodities; consumer risk assessment; Consumers; Context; courgettes; Cucumbers; Enforcement; gherkins; Harvest; imazalil; Investigations; Liquid chromatography; Mass spectrometry; Metabolism; Metabolites; MRL; Peer review; pesticide; Reasoned Opinion; Residues; Risk assessment; Risk management; Scientific imaging; Netherlands; gherkins; cucumbers; consumer risk assessment; MRL; imazalil; pesticide; courgettes
• ISSN: 1831-4732; 1831-4732; 2314-9396
• DOI: 10.2903/j.efsa.2023.7980

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Certis Europe B.V. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance imazalil in cucumbers, courgettes and gherkins. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 0.08 mg/kg for the whole group of cucurbits with edible peel. It is noted that the derived MRL is proposed to replace the existing tentative MRL of 0.1 mg/kg for courgettes, thus also addressing the data gap identified in the context of the MRL review. As regards to cucumbers and gherkins, it is noted that the MRL proposal derived in the current application is covered by the MRL of 0.5 mg/kg currently in place for these commodities. Nevertheless, it is also noted that the aforementioned MRLs are based on Codex maximum residue limits (CXLs) which were revoked in 2019 following the JMPR proposal. Should this proposal be implemented in the EU regulation in the future, the proposed MRL of 0.08 mg/kg as derived in the current application would be considered an appropriate fall‐back option for the whole group of cucurbits with edible peel. Further risk management considerations are therefore required. Adequate analytical methods for enforcement are available to control the residues of imazalil on the commodities under consideration at the validated limit of quantification (LOQ) of 0.005 mg/kg (QuEChERS method based on LC–MS/MS) and 0.01 mg/kg (HPLC–MS/MS method). Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of imazalil according to the reported agricultural practices is unlikely to present a risk to consumer health. However, it should be noted that a high degree of uncertainty on the overall long‐term exposure calculation remains due to the data gaps identified in the context of the MRL review on full toxicological assessment of the metabolite R014821, which is expected to occur following post‐harvest uses of imazalil, and animal metabolites FK‐772 and FK‐284.