PMID- 33603896 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210220 IS - 1831-4732 (Electronic) IS - 1831-4732 (Linking) VI - 19 IP - 2 DP - 2021 Feb TI - Modification of the existing maximum residue levels for difenoconazole in leafy brassica. PG - e06407 LID - 10.2903/j.efsa.2021.6407 [doi] LID - e06407 AB - In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in commodities belonging to the group of leafy brassica. The data submitted in support of the request were found to be sufficient to derive MRL proposals for leafy brassica. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in plant matrices under consideration at the validated LOQ of 0.01 mg/kg and for difenoconazole and metabolite CGA205375 in animal matrices at the validated LOQ of 0.01 mg/kg for meat muscle, fat, liver, kidney and eggs and at the validated LOQ of 0.005 mg/kg for milk. Based on the risk assessment results, EFSA concluded that for the crops assessed in this application the short-term intake of residues resulting from the use of difenoconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. Long-term consumer intake concerns cannot be excluded for the intended and existing difenoconazole uses as they are affected by uncertainties associated with the toxicity of metabolite CGA205375 and the lack of information on all existing difenoconazole uses in the EU. Overall, this risk assessment is considered provisional, pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and has to be re-considered when the missing data become available. Additionally, this assessment does not take into consideration triazole derivative metabolites (TDMs) which may be generated by several pesticides belonging to the group of triazole fungicides as this application was submitted before September 2019 which is the date of application of the new strategy endorsed by the risk managers for the assessment of TDMs. CI - (c) 2021 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 - Anastassiadou, Maria AU - Anastassiadou M FAU - Bernasconi, Giovanni AU - Bernasconi G FAU - Brancato, Alba AU - Brancato A FAU - Carrasco Cabrera, Luis AU - Carrasco Cabrera L FAU - Ferreira, Lucien AU - Ferreira L FAU - Greco, Luna AU - Greco L FAU - Jarrah, Samira AU - Jarrah S FAU - Kazocina, Aija AU - Kazocina A FAU - Leuschner, Renata AU - Leuschner R FAU - Magrans, Jose Oriol AU - Magrans JO FAU - Miron, Ileana AU - Miron I FAU - Nave, Stefanie AU - Nave S FAU - Pedersen, Ragnor AU - Pedersen R FAU - Reich, Hermine AU - Reich H FAU - Rojas, Alejandro AU - Rojas A FAU - Sacchi, Angela AU - Sacchi A FAU - Santos, Miguel AU - Santos M FAU - Scarlato, Alessia Pia AU - Scarlato AP FAU - Theobald, Anne AU - Theobald A FAU - Vagenende, Benedicte AU - Vagenende B FAU - Verani, Alessia AU - Verani A LA - eng PT - Journal Article DEP - 20210209 PL - United States TA - EFSA J JT - EFSA journal. European Food Safety Authority JID - 101642076 PMC - PMC7871204 OTO - NOTNLM OT - MRL OT - consumer risk assessment OT - difenoconazole OT - kale OT - leafy brassica OT - pesticide EDAT- 2021/02/20 06:00 MHDA- 2021/02/20 06:01 PMCR- 2021/02/09 CRDT- 2021/02/19 06:06 PHST- 2021/02/19 06:06 [entrez] PHST- 2021/02/20 06:00 [pubmed] PHST- 2021/02/20 06:01 [medline] PHST- 2021/02/09 00:00 [pmc-release] AID - EFS26407 [pii] AID - 10.2903/j.efsa.2021.6407 [doi] PST - epublish SO - EFSA J. 2021 Feb 9;19(2):e06407. doi: 10.2903/j.efsa.2021.6407. eCollection 2021 Feb.