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Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole

The applicant Corteva Agrosciences submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for fenbuconazole in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the Article...

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Autores principales: Bellisai, Giulia, Bernasconi, Giovanni, Carrasco Cabrera, Luis, Castellan, Irene, del Aguila, Monica, Ferreira, Lucien, Giner Santonja, German, Greco, Luna, Jarrah, Samira, Leuschner, Renata, Perez, Javier Martinez, Miron, Ileana, Nave, Stefanie, Pedersen, Ragnor, Reich, Hermine, Ruocco, Silvia, Santos, Miguel, Scarlato, Alessia Pia, Theobald, Anne, Tiramani, Manuela, Verani, Alessia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10416013/
https://www.ncbi.nlm.nih.gov/pubmed/37575616
http://dx.doi.org/10.2903/j.efsa.2023.8205
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author Bellisai, Giulia
Bernasconi, Giovanni
Carrasco Cabrera, Luis
Castellan, Irene
del Aguila, Monica
Ferreira, Lucien
Giner Santonja, German
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Perez, Javier Martinez
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Tiramani, Manuela
Verani, Alessia
author_facet Bellisai, Giulia
Bernasconi, Giovanni
Carrasco Cabrera, Luis
Castellan, Irene
del Aguila, Monica
Ferreira, Lucien
Giner Santonja, German
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Perez, Javier Martinez
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Tiramani, Manuela
Verani, Alessia
collection PubMed
description The applicant Corteva Agrosciences submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for fenbuconazole in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the Article 12 confirmatory data gaps, new residue trials analysing triazole derivative metabolites (TDMs) were submitted on grapefruits, lemons, apples, pears, peaches, cherries and blueberries. Following the assessment of submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for grapefruits, oranges, lemons, limes, pome fruits, peaches, cherries and blueberries. The calculated livestock dietary burdens indicated that for the individual TDMs, the trigger value of 0.004 mg/kg bw day is not exceed from the intake of apple pomace and citrus dried pulp. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No data were submitted to address the Article 12 confirmatory data gaps for tree nuts, apricots, plums, table grapes, wine grapes, cranberries, bananas, sweet peppers/bell peppers, cucurbits with edible/inedible peel, peanuts/groundnuts, sunflower seeds and rapeseeds/canola seeds, barley, rye and wheat. For these commodities, the existing EU MRL could be lowered to the enforcement LOQ.
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spelling pubmed-104160132023-08-12 Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole Bellisai, Giulia Bernasconi, Giovanni Carrasco Cabrera, Luis Castellan, Irene del Aguila, Monica Ferreira, Lucien Giner Santonja, German Greco, Luna Jarrah, Samira Leuschner, Renata Perez, Javier Martinez Miron, Ileana Nave, Stefanie Pedersen, Ragnor Reich, Hermine Ruocco, Silvia Santos, Miguel Scarlato, Alessia Pia Theobald, Anne Tiramani, Manuela Verani, Alessia EFSA J Reasoned Opinion The applicant Corteva Agrosciences submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for fenbuconazole in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the Article 12 confirmatory data gaps, new residue trials analysing triazole derivative metabolites (TDMs) were submitted on grapefruits, lemons, apples, pears, peaches, cherries and blueberries. Following the assessment of submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for grapefruits, oranges, lemons, limes, pome fruits, peaches, cherries and blueberries. The calculated livestock dietary burdens indicated that for the individual TDMs, the trigger value of 0.004 mg/kg bw day is not exceed from the intake of apple pomace and citrus dried pulp. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No data were submitted to address the Article 12 confirmatory data gaps for tree nuts, apricots, plums, table grapes, wine grapes, cranberries, bananas, sweet peppers/bell peppers, cucurbits with edible/inedible peel, peanuts/groundnuts, sunflower seeds and rapeseeds/canola seeds, barley, rye and wheat. For these commodities, the existing EU MRL could be lowered to the enforcement LOQ. John Wiley and Sons Inc. 2023-08-11 /pmc/articles/PMC10416013/ /pubmed/37575616 http://dx.doi.org/10.2903/j.efsa.2023.8205 Text en © 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Reasoned Opinion
Bellisai, Giulia
Bernasconi, Giovanni
Carrasco Cabrera, Luis
Castellan, Irene
del Aguila, Monica
Ferreira, Lucien
Giner Santonja, German
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Perez, Javier Martinez
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Tiramani, Manuela
Verani, Alessia
Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole
title Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole
title_full Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole
title_fullStr Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole
title_full_unstemmed Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole
title_short Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole
title_sort evaluation of confirmatory data following the article 12 mrl review for fenbuconazole
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10416013/
https://www.ncbi.nlm.nih.gov/pubmed/37575616
http://dx.doi.org/10.2903/j.efsa.2023.8205
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