Evaluation of confirmatory data following the Article 12 MRL review for napropamide
2023
European Food Safety Authority (EFSA) | Giulia Bellisai | Giovanni Bernasconi | Luis Carrasco Cabrera | Irene Castellan | Monica Del Aguila | Lucien Ferreira | German Giner Santonja | Luna Greco | Samira Jarrah | Renata Leuschner | Javier Martinez Perez | Ileana Miron | Stefanie Nave | Ragnor Pedersen | Hermine Reich | Silvia Ruocco | Miguel Santos | Alessia Pia Scarlato | Anne Theobald | Manuela Tiramani | Alessia Verani
Abstract 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.
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