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

The applicant ISK Biosciences Europe N.V, submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flonicamid in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not availab...

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Autores principales: Anastassiadou, Maria, Bernasconi, Giovanni, Brancato, Alba, Carrasco Cabrera, Luis, Greco, Luna, Jarrah, Samira, Kazocina, Aija, Leuschner, Renata, Magrans, Jose Oriol, Miron, Ileana, Nave, Stefanie, Pedersen, Ragnor, Reich, Hermine, Rojas, Alejandro, Sacchi, Angela, Santos, Miguel, Stanek, Alois, Theobald, Anne, Vagenende, Benedicte, Verani, Alessia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10464708/
https://www.ncbi.nlm.nih.gov/pubmed/37649517
http://dx.doi.org/10.2903/j.efsa.2020.6117
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author Anastassiadou, Maria
Bernasconi, Giovanni
Brancato, Alba
Carrasco Cabrera, Luis
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Rojas, Alejandro
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
author_facet Anastassiadou, Maria
Bernasconi, Giovanni
Brancato, Alba
Carrasco Cabrera, Luis
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Rojas, Alejandro
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
collection PubMed
description The applicant ISK Biosciences Europe N.V, submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flonicamid in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. In order to address the data gaps, the applicant provided method validation data for hops, residue trials on cherries, plums, tomatoes and melons and referred to results from trials in cucumbers and storage stability and hydrolysis studies which have been assessed in previous EFSA outputs. The provided information was considered sufficient to address the confirmatory data gaps for hops, cherries, plums, tomatoes and aubergines, courgettes and cucurbits with inedible peel. EFSA updated the most recent consumer risk assessment for flonicamid and concluded that for the crops under assessment, the long‐term and short‐term dietary intake is unlikely to present a risk to consumer health.
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spelling pubmed-104647082023-08-30 Evaluation of confirmatory data following the Article 12 MRL review for flonicamid Anastassiadou, Maria Bernasconi, Giovanni Brancato, Alba Carrasco Cabrera, Luis Greco, Luna Jarrah, Samira Kazocina, Aija Leuschner, Renata Magrans, Jose Oriol Miron, Ileana Nave, Stefanie Pedersen, Ragnor Reich, Hermine Rojas, Alejandro Sacchi, Angela Santos, Miguel Stanek, Alois Theobald, Anne Vagenende, Benedicte Verani, Alessia EFSA J Reasoned Opinion The applicant ISK Biosciences Europe N.V, submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flonicamid in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. In order to address the data gaps, the applicant provided method validation data for hops, residue trials on cherries, plums, tomatoes and melons and referred to results from trials in cucumbers and storage stability and hydrolysis studies which have been assessed in previous EFSA outputs. The provided information was considered sufficient to address the confirmatory data gaps for hops, cherries, plums, tomatoes and aubergines, courgettes and cucurbits with inedible peel. EFSA updated the most recent consumer risk assessment for flonicamid and concluded that for the crops under assessment, the long‐term and short‐term dietary intake is unlikely to present a risk to consumer health. John Wiley and Sons Inc. 2020-05-13 /pmc/articles/PMC10464708/ /pubmed/37649517 http://dx.doi.org/10.2903/j.efsa.2020.6117 Text en © 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd 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
Anastassiadou, Maria
Bernasconi, Giovanni
Brancato, Alba
Carrasco Cabrera, Luis
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Rojas, Alejandro
Sacchi, Angela
Santos, Miguel
Stanek, Alois
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
Evaluation of confirmatory data following the Article 12 MRL review for flonicamid
title Evaluation of confirmatory data following the Article 12 MRL review for flonicamid
title_full Evaluation of confirmatory data following the Article 12 MRL review for flonicamid
title_fullStr Evaluation of confirmatory data following the Article 12 MRL review for flonicamid
title_full_unstemmed Evaluation of confirmatory data following the Article 12 MRL review for flonicamid
title_short Evaluation of confirmatory data following the Article 12 MRL review for flonicamid
title_sort evaluation of confirmatory data following the article 12 mrl review for flonicamid
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10464708/
https://www.ncbi.nlm.nih.gov/pubmed/37649517
http://dx.doi.org/10.2903/j.efsa.2020.6117
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