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

The applicant Nihon Nohyaku Co. Ltd. submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flutolanil in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. T...

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Autores principales: Abdourahime, Himdata, Anastassiadou, Maria, Brancato, Alba, Brocca, Daniela, Carrasco Cabrera, Luis, De Lentdecker, Chloe, Ferreira, Lucien, Greco, Luna, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, Lythgo, Christopher, Medina, Paula, Miron, Ileana, Molnar, Tunde, Nave, Stefanie, Pedersen, Ragnor, Raczyk, Marianna, Reich, Hermine, Ruocco, Silvia, Sacchi, Angela, Santos, Miguel, Stanek, Alois, Sturma, Juergen, Tarazona, Jose, Theobald, Anne, Vagenende, Benedicte, Verani, Alessia, Villamar‐Bouza, Laura
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009047/
https://www.ncbi.nlm.nih.gov/pubmed/32626220
http://dx.doi.org/10.2903/j.efsa.2019.5593
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author Abdourahime, Himdata
Anastassiadou, Maria
Brancato, Alba
Brocca, Daniela
Carrasco Cabrera, Luis
De Lentdecker, Chloe
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kardassi, Dimitra
Leuschner, Renata
Lostia, Alfonso
Lythgo, Christopher
Medina, Paula
Miron, Ileana
Molnar, Tunde
Nave, Stefanie
Pedersen, Ragnor
Raczyk, Marianna
Reich, Hermine
Ruocco, Silvia
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Sturma, Juergen
Tarazona, Jose
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
Villamar‐Bouza, Laura
author_facet Abdourahime, Himdata
Anastassiadou, Maria
Brancato, Alba
Brocca, Daniela
Carrasco Cabrera, Luis
De Lentdecker, Chloe
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kardassi, Dimitra
Leuschner, Renata
Lostia, Alfonso
Lythgo, Christopher
Medina, Paula
Miron, Ileana
Molnar, Tunde
Nave, Stefanie
Pedersen, Ragnor
Raczyk, Marianna
Reich, Hermine
Ruocco, Silvia
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Sturma, Juergen
Tarazona, Jose
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
Villamar‐Bouza, Laura
collection PubMed
description The applicant Nihon Nohyaku Co. Ltd. submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flutolanil in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to new residue trials for globe artichokes and beans with pods and for storage stability data in products of animal origin were addressed. Further risk management consideration is required regarding the tentative MRL on peppers and on certain products of animal origin, since the data gaps identified in the MRL review were not addressed or only partially addressed. A new metabolism study on ruminants was provided which will be assessed in the framework of the renewal of the active substance flutolanil; formally, this data gap is considered to be addressed. EFSA updated the most recent consumer risk assessment for flutolanil and concluded that the long‐term dietary intake is unlikely to present a risk to consumer health. The conclusion reported in this reasoned opinion may need to be reconsidered in light of the outcome of the EU pesticides peer review.
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spelling pubmed-70090472020-07-02 Evaluation of confirmatory data following the Article 12 MRL review for flutolanil Abdourahime, Himdata Anastassiadou, Maria Brancato, Alba Brocca, Daniela Carrasco Cabrera, Luis De Lentdecker, Chloe Ferreira, Lucien Greco, Luna Jarrah, Samira Kardassi, Dimitra Leuschner, Renata Lostia, Alfonso Lythgo, Christopher Medina, Paula Miron, Ileana Molnar, Tunde Nave, Stefanie Pedersen, Ragnor Raczyk, Marianna Reich, Hermine Ruocco, Silvia Sacchi, Angela Santos, Miguel Stanek, Alois Sturma, Juergen Tarazona, Jose Theobald, Anne Vagenende, Benedicte Verani, Alessia Villamar‐Bouza, Laura EFSA J Reasoned Opinion The applicant Nihon Nohyaku Co. Ltd. submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flutolanil in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to new residue trials for globe artichokes and beans with pods and for storage stability data in products of animal origin were addressed. Further risk management consideration is required regarding the tentative MRL on peppers and on certain products of animal origin, since the data gaps identified in the MRL review were not addressed or only partially addressed. A new metabolism study on ruminants was provided which will be assessed in the framework of the renewal of the active substance flutolanil; formally, this data gap is considered to be addressed. EFSA updated the most recent consumer risk assessment for flutolanil and concluded that the long‐term dietary intake is unlikely to present a risk to consumer health. The conclusion reported in this reasoned opinion may need to be reconsidered in light of the outcome of the EU pesticides peer review. John Wiley and Sons Inc. 2019-02-04 /pmc/articles/PMC7009047/ /pubmed/32626220 http://dx.doi.org/10.2903/j.efsa.2019.5593 Text en © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://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
Abdourahime, Himdata
Anastassiadou, Maria
Brancato, Alba
Brocca, Daniela
Carrasco Cabrera, Luis
De Lentdecker, Chloe
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kardassi, Dimitra
Leuschner, Renata
Lostia, Alfonso
Lythgo, Christopher
Medina, Paula
Miron, Ileana
Molnar, Tunde
Nave, Stefanie
Pedersen, Ragnor
Raczyk, Marianna
Reich, Hermine
Ruocco, Silvia
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Sturma, Juergen
Tarazona, Jose
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
Villamar‐Bouza, Laura
Evaluation of confirmatory data following the Article 12 MRL review for flutolanil
title Evaluation of confirmatory data following the Article 12 MRL review for flutolanil
title_full Evaluation of confirmatory data following the Article 12 MRL review for flutolanil
title_fullStr Evaluation of confirmatory data following the Article 12 MRL review for flutolanil
title_full_unstemmed Evaluation of confirmatory data following the Article 12 MRL review for flutolanil
title_short Evaluation of confirmatory data following the Article 12 MRL review for flutolanil
title_sort evaluation of confirmatory data following the article 12 mrl review for flutolanil
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009047/
https://www.ncbi.nlm.nih.gov/pubmed/32626220
http://dx.doi.org/10.2903/j.efsa.2019.5593
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