PMID- 32625729 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240328 IS - 1831-4732 (Electronic) IS - 1831-4732 (Linking) VI - 16 IP - 10 DP - 2018 Oct TI - Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information. PG - e05453 LID - 10.2903/j.efsa.2018.5453 [doi] LID - e05453 AB - In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK-772 and FK-284. EFSA did not derive MRL proposals from the post-harvest uses reported on citrus fruits, apples, pears, potatoes, bananas and melons because the assessment of the toxicological properties of the metabolite R014821 (expected to occur following post-harvest application of imazalil) could not be finalised. Risk managers should be made aware that the genotoxic potential of the metabolite R014821 could not be ruled out. For all these commodities, a decision on the residue definition for risk assessment could not be taken, which is a perquisite to perform a reliable dietary risk assessment. For the other commodities and considering fall-back Good Agricultural Practices (GAPs) when possible, some information required by the regulatory framework was missing. Hence, although no apparent risk to consumers was identified, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. It is noted that MRL proposals in commodities of animal origin were not derived because, provided that GAPs with post-harvest applications would be withdrawn, the livestock exposure is not expected to exceed the trigger value. Nevertheless, it is noted that lacking of information/data (in particular on the toxicity of metabolites FK-772 ad FK-284) was also identified, which prevent from proposing residue definition for enforcement and risk assessment in livestock commodities. CI - (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. CN - European Food Safety Authority (EFSA) FAU - Brancato, Alba AU - Brancato A FAU - Brocca, Daniela AU - Brocca D FAU - Carrasco Cabrera, Luis AU - Carrasco Cabrera L FAU - De Lentdecker, Chloe AU - De Lentdecker C FAU - Erdos, Zoltan AU - Erdos Z FAU - Ferreira, Lucien AU - Ferreira L FAU - Greco, Luna AU - Greco L FAU - Jarrah, Samira AU - Jarrah S FAU - Kardassi, Dimitra AU - Kardassi D FAU - Leuschner, Renata AU - Leuschner R FAU - Lostia, Alfonso AU - Lostia A FAU - Lythgo, Christopher AU - Lythgo C FAU - Medina, Paula AU - Medina P FAU - Miron, Ileana AU - Miron I FAU - Molnar, Tunde AU - Molnar T FAU - Pedersen, Ragnor AU - Pedersen R FAU - Reich, Hermine AU - Reich H FAU - Sacchi, Angela AU - Sacchi A FAU - Santos, Miguel AU - Santos M FAU - Stanek, Alois AU - Stanek A FAU - Sturma, Juergen AU - Sturma J FAU - Tarazona, Jose AU - Tarazona J FAU - Theobald, Anne AU - Theobald A FAU - Vagenende, Benedicte AU - Vagenende B FAU - Villamar-Bouza, Laura AU - Villamar-Bouza L LA - eng PT - Journal Article DEP - 20181030 PL - United States TA - EFSA J JT - EFSA journal. European Food Safety Authority JID - 101642076 PMC - PMC7009713 OTO - NOTNLM OT - MRL review OT - Regulation (EC) No 396/2005 OT - consumer risk assessment OT - fungicide OT - imazalil OT - imidazole OT - pesticide EDAT- 2018/10/30 00:00 MHDA- 2018/10/30 00:01 PMCR- 2018/10/30 CRDT- 2020/07/07 06:00 PHST- 2020/07/07 06:00 [entrez] PHST- 2018/10/30 00:00 [pubmed] PHST- 2018/10/30 00:01 [medline] PHST- 2018/10/30 00:00 [pmc-release] AID - EFS25453 [pii] AID - 10.2903/j.efsa.2018.5453 [doi] PST - epublish SO - EFSA J. 2018 Oct 30;16(10):e05453. doi: 10.2903/j.efsa.2018.5453. eCollection 2018 Oct.