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

The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for bentazone in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To addres...

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Autores principales: Anastassiadou, Maria, Brancato, Alba, Brocca, Daniela, Carrasco Cabrera, Luis, Ferreira, Lucien, Greco, Luna, Jarrah, Samira, Kazocina, Aija, Leuschner, Renata, Lostia, Alfonso, Magrans, Jose Oriol, Medina, Paula, Miron, Ileana, Pedersen, Ragnor, Raczyk, Marianna, Reich, Hermine, Ruocco, Silvia, Sacchi, Angela, Santos, Miguel, Stanek, Alois, Tarazona, Jose, Theobald, Anne, Verani, Alessia
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/PMC7009258/
https://www.ncbi.nlm.nih.gov/pubmed/32626326
http://dx.doi.org/10.2903/j.efsa.2019.5704
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author Anastassiadou, Maria
Brancato, Alba
Brocca, Daniela
Carrasco Cabrera, Luis
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Lostia, Alfonso
Magrans, Jose Oriol
Medina, Paula
Miron, Ileana
Pedersen, Ragnor
Raczyk, Marianna
Reich, Hermine
Ruocco, Silvia
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Tarazona, Jose
Theobald, Anne
Verani, Alessia
author_facet Anastassiadou, Maria
Brancato, Alba
Brocca, Daniela
Carrasco Cabrera, Luis
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Lostia, Alfonso
Magrans, Jose Oriol
Medina, Paula
Miron, Ileana
Pedersen, Ragnor
Raczyk, Marianna
Reich, Hermine
Ruocco, Silvia
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Tarazona, Jose
Theobald, Anne
Verani, Alessia
collection PubMed
description The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for bentazone in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new livestock feeding study and storage stability data for bentazone and 6‐hydroxy bentazone in animal matrices were submitted. To address the data gap for potatoes, adjusted less critical good agricultural practices (GAPs) were reported and supporting residue data were provided. The data gap related to analytical methods in fat and herbal infusions were addressed in the framework of the peer review. The data gap for residue trials on leek has not been addressed. Further confirmation from the applicant/Member States are needed for the clarification of the GAP for herbal infusions. Based on the information submitted in support of the confirmatory data request, the existing EU MRLs for bentazone need to be modified for potato and leek, for swine fat and kidney and for bovine, equine, goat and sheep fat, liver and milk. The consumer risk assessment performed in the MRL review was updated, using new toxicological reference values derived by the peer review. No consumer intake concerns were identified.
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spelling pubmed-70092582020-07-02 Evaluation of confirmatory data following the Article 12 MRL review for bentazone Anastassiadou, Maria Brancato, Alba Brocca, Daniela Carrasco Cabrera, Luis Ferreira, Lucien Greco, Luna Jarrah, Samira Kazocina, Aija Leuschner, Renata Lostia, Alfonso Magrans, Jose Oriol Medina, Paula Miron, Ileana Pedersen, Ragnor Raczyk, Marianna Reich, Hermine Ruocco, Silvia Sacchi, Angela Santos, Miguel Stanek, Alois Tarazona, Jose Theobald, Anne Verani, Alessia EFSA J Reasoned Opinion The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for bentazone in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new livestock feeding study and storage stability data for bentazone and 6‐hydroxy bentazone in animal matrices were submitted. To address the data gap for potatoes, adjusted less critical good agricultural practices (GAPs) were reported and supporting residue data were provided. The data gap related to analytical methods in fat and herbal infusions were addressed in the framework of the peer review. The data gap for residue trials on leek has not been addressed. Further confirmation from the applicant/Member States are needed for the clarification of the GAP for herbal infusions. Based on the information submitted in support of the confirmatory data request, the existing EU MRLs for bentazone need to be modified for potato and leek, for swine fat and kidney and for bovine, equine, goat and sheep fat, liver and milk. The consumer risk assessment performed in the MRL review was updated, using new toxicological reference values derived by the peer review. No consumer intake concerns were identified. John Wiley and Sons Inc. 2019-05-22 /pmc/articles/PMC7009258/ /pubmed/32626326 http://dx.doi.org/10.2903/j.efsa.2019.5704 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
Anastassiadou, Maria
Brancato, Alba
Brocca, Daniela
Carrasco Cabrera, Luis
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Lostia, Alfonso
Magrans, Jose Oriol
Medina, Paula
Miron, Ileana
Pedersen, Ragnor
Raczyk, Marianna
Reich, Hermine
Ruocco, Silvia
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Tarazona, Jose
Theobald, Anne
Verani, Alessia
Evaluation of confirmatory data following the Article 12 MRL review for bentazone
title Evaluation of confirmatory data following the Article 12 MRL review for bentazone
title_full Evaluation of confirmatory data following the Article 12 MRL review for bentazone
title_fullStr Evaluation of confirmatory data following the Article 12 MRL review for bentazone
title_full_unstemmed Evaluation of confirmatory data following the Article 12 MRL review for bentazone
title_short Evaluation of confirmatory data following the Article 12 MRL review for bentazone
title_sort evaluation of confirmatory data following the article 12 mrl review for bentazone
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009258/
https://www.ncbi.nlm.nih.gov/pubmed/32626326
http://dx.doi.org/10.2903/j.efsa.2019.5704
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