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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2023
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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. |
format | Online Article Text |
id | pubmed-10416013 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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