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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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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. |
format | Online Article Text |
id | pubmed-7009047 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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