PMID- 37485252 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230725 IS - 1831-4732 (Electronic) IS - 1831-4732 (Linking) VI - 21 IP - 7 DP - 2023 Jul TI - Evaluation of confirmatory data following the Article 12 MRL review for napropamide. PG - e08125 LID - 10.2903/j.efsa.2023.8125 [doi] LID - e08125 AB - The applicant UPL Europe Ltd submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for napropamide in the framework of the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new storage stability study on grapes (high acid content commodity) was submitted while a metabolism study in fruit crops following foliar treatment, residue trials on fresh herbs and edible flowers and an analytical method for matrices difficult to analyse were not submitted. Therefore, only the data gap for storage stability was satisfactorily addressed. The new information provided required a revision of the tentative MRLs for commodities where confirmatory data were indicated. An update of the consumer risk assessment for napropamide was performed considering the new data submitted and it did not indicate any consumer intake concerns in relation to the chronic exposure. CI - (c) 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority. CN - European Food Safety Authority (EFSA) FAU - Bellisai, Giulia AU - Bellisai G FAU - Bernasconi, Giovanni AU - Bernasconi G FAU - Carrasco Cabrera, Luis AU - Carrasco Cabrera L FAU - Castellan, Irene AU - Castellan I FAU - Del Aguila, Monica AU - Del Aguila M FAU - Ferreira, Lucien AU - Ferreira L FAU - Giner Santonja, German AU - Giner Santonja G FAU - Greco, Luna AU - Greco L FAU - Jarrah, Samira AU - Jarrah S FAU - Leuschner, Renata AU - Leuschner R FAU - Perez, Javier Martinez AU - Perez JM 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 - Ruocco, Silvia AU - Ruocco S FAU - Santos, Miguel AU - Santos M FAU - Scarlato, Alessia Pia AU - Scarlato AP FAU - Theobald, Anne AU - Theobald A FAU - Tiramani, Manuela AU - Tiramani M FAU - Verani, Alessia AU - Verani A LA - eng PT - Journal Article DEP - 20230720 PL - United States TA - EFSA J JT - EFSA journal. European Food Safety Authority JID - 101642076 PMC - PMC10358196 OTO - NOTNLM OT - MRL review OT - confirmatory data OT - napropamide OT - pesticide OT - risk assessment EDAT- 2023/07/24 06:42 MHDA- 2023/07/24 06:43 PMCR- 2023/07/20 CRDT- 2023/07/24 04:55 PHST- 2023/07/24 06:43 [medline] PHST- 2023/07/24 06:42 [pubmed] PHST- 2023/07/24 04:55 [entrez] PHST- 2023/07/20 00:00 [pmc-release] AID - EFS28125 [pii] AID - 10.2903/j.efsa.2023.8125 [doi] PST - epublish SO - EFSA J. 2023 Jul 20;21(7):e08125. doi: 10.2903/j.efsa.2023.8125. eCollection 2023 Jul.