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Modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted an application to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for bentazone in soyabeans and poppy seeds. The data submitted in support of the req...

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Autores principales: Anastassiadou, Maria, Brancato, Alba, Carrasco Cabrera, Luis, Ferreira, Lucien, Greco, Luna, Jarrah, Samira, Kazocina, Aija, Leuschner, Renata, Magrans, Jose Oriol, Miron, Ileana, Nave, Stefanie, Pedersen, Ragnor, Reich, Hermine, Sacchi, Angela, Santos, Miguel, Stanek, Alois, Theobald, Anne, Vagenende, Benedicte, 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/PMC7009028/
https://www.ncbi.nlm.nih.gov/pubmed/32626412
http://dx.doi.org/10.2903/j.efsa.2019.5798
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author Anastassiadou, Maria
Brancato, Alba
Carrasco Cabrera, Luis
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
author_facet Anastassiadou, Maria
Brancato, Alba
Carrasco Cabrera, Luis
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
collection PubMed
description In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted an application to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for bentazone in soyabeans and poppy seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for both commodities. Adequate analytical methods for enforcement are available to control the residues of bentazone and its metabolites in plant matrices under consideration. The studies requested by EFSA in the framework of the peer review to address the toxicological properties of metabolite 6‐hydroxy‐bentazone were only partially provided. Instead of studies investigating the general toxicity of this metabolite, the applicant provided an argumentation to justify read‐across from the available information on parent bentazone and 8‐hydroxy‐bentazone. EFSA did not agree with the provided reasoning for read‐across. Therefore, the EMS asked EFSA to continue the assessment despite the data gap. EFSA performed an indicative short‐term and long‐term dietary risk assessment; the calculated dietary exposure was well below the toxicological reference values. The risk assessment however is affected by additional, non‐standard uncertainties resulting from data gap related to the toxicological properties for 6‐hydroxy‐bentazone.
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spelling pubmed-70090282020-07-02 Modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds Anastassiadou, Maria Brancato, Alba Carrasco Cabrera, Luis Ferreira, Lucien Greco, Luna Jarrah, Samira Kazocina, Aija Leuschner, Renata Magrans, Jose Oriol Miron, Ileana Nave, Stefanie Pedersen, Ragnor Reich, Hermine Sacchi, Angela Santos, Miguel Stanek, Alois Theobald, Anne Vagenende, Benedicte Verani, Alessia EFSA J Reasoned Opinion In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted an application to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for bentazone in soyabeans and poppy seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for both commodities. Adequate analytical methods for enforcement are available to control the residues of bentazone and its metabolites in plant matrices under consideration. The studies requested by EFSA in the framework of the peer review to address the toxicological properties of metabolite 6‐hydroxy‐bentazone were only partially provided. Instead of studies investigating the general toxicity of this metabolite, the applicant provided an argumentation to justify read‐across from the available information on parent bentazone and 8‐hydroxy‐bentazone. EFSA did not agree with the provided reasoning for read‐across. Therefore, the EMS asked EFSA to continue the assessment despite the data gap. EFSA performed an indicative short‐term and long‐term dietary risk assessment; the calculated dietary exposure was well below the toxicological reference values. The risk assessment however is affected by additional, non‐standard uncertainties resulting from data gap related to the toxicological properties for 6‐hydroxy‐bentazone. John Wiley and Sons Inc. 2019-08-02 /pmc/articles/PMC7009028/ /pubmed/32626412 http://dx.doi.org/10.2903/j.efsa.2019.5798 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
Carrasco Cabrera, Luis
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
Modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds
title Modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds
title_full Modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds
title_fullStr Modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds
title_full_unstemmed Modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds
title_short Modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds
title_sort modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009028/
https://www.ncbi.nlm.nih.gov/pubmed/32626412
http://dx.doi.org/10.2903/j.efsa.2019.5798
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