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Evaluation of confirmatory data following Article 12 MRL review and modification of the existing MRLs in pome fruits for pyridaben

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe SAS submitted a request to the competent national authority in the Czech Republic to modify the existing maximum residue levels (MRLs) in pome fruits and to evaluate the confirmatory data identified in...

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Autores principales: Bellisai, Giulia, Bernasconi, Giovanni, Brancato, Alba, Cabrera, Luis Carrasco, Castellan, Irene, Del Aguila, Monica, Ferreira, Lucien, Santonja, German Giner, Greco, Luna, Jarrah, Samira, Leuschner, Renata, Magrans, Jose Oriol, Miron, Ileana, Nave, Stefanie, Pedersen, Ragnor, Reich, Hermine, Robinson, Tobin, Ruocco, Silvia, Santos, Miguel, Scarlato, Alessia Pia, Theobald, Anne, Verani, Alessia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10108001/
https://www.ncbi.nlm.nih.gov/pubmed/37077298
http://dx.doi.org/10.2903/j.efsa.2023.7970
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author Bellisai, Giulia
Bernasconi, Giovanni
Brancato, Alba
Cabrera, Luis Carrasco
Castellan, Irene
Del Aguila, Monica
Ferreira, Lucien
Santonja, German Giner
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Robinson, Tobin
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Verani, Alessia
author_facet Bellisai, Giulia
Bernasconi, Giovanni
Brancato, Alba
Cabrera, Luis Carrasco
Castellan, Irene
Del Aguila, Monica
Ferreira, Lucien
Santonja, German Giner
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Robinson, Tobin
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Verani, Alessia
collection PubMed
description In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe SAS submitted a request to the competent national authority in the Czech Republic to modify the existing maximum residue levels (MRLs) in pome fruits and to evaluate the confirmatory data identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps on residue trials, new trials according to the Good Agricultural Practices (GAPs) on apples, pears, medlars, quinces, loquats/Japanese medlars, apricots, peaches and beans with pods evaluated during the MRL review were not provided. These data gaps are not addressed. However, residue trials on apples and pears for an alternative GAP were provided and resulted by extrapolation in an MRL proposal for pome fruits lower than the current (tentative) MRL in EU legislation. The provided information may require a revision of the existing MRLs for pome fruits, apricots, peaches and beans with pods. Information on storage temperature of samples from the feeding study and a validated analytical method for animal commodities were submitted. The two data gaps on animal commodities were satisfactorily addressed. Adequate analytical methods for enforcement are available to control the residues of pyridaben in plant matrices under consideration and in all animal matrices, where currently an limit of quantification (LOQ) of 0.02 mg/kg is considered at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of pyridaben according to the reported agricultural practices is unlikely to present a risk to consumer health.
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spelling pubmed-101080012023-04-18 Evaluation of confirmatory data following Article 12 MRL review and modification of the existing MRLs in pome fruits for pyridaben Bellisai, Giulia Bernasconi, Giovanni Brancato, Alba Cabrera, Luis Carrasco Castellan, Irene Del Aguila, Monica Ferreira, Lucien Santonja, German Giner Greco, Luna Jarrah, Samira Leuschner, Renata Magrans, Jose Oriol Miron, Ileana Nave, Stefanie Pedersen, Ragnor Reich, Hermine Robinson, Tobin Ruocco, Silvia Santos, Miguel Scarlato, Alessia Pia Theobald, Anne Verani, Alessia EFSA J Reasoned Opinion In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe SAS submitted a request to the competent national authority in the Czech Republic to modify the existing maximum residue levels (MRLs) in pome fruits and to evaluate the confirmatory data identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps on residue trials, new trials according to the Good Agricultural Practices (GAPs) on apples, pears, medlars, quinces, loquats/Japanese medlars, apricots, peaches and beans with pods evaluated during the MRL review were not provided. These data gaps are not addressed. However, residue trials on apples and pears for an alternative GAP were provided and resulted by extrapolation in an MRL proposal for pome fruits lower than the current (tentative) MRL in EU legislation. The provided information may require a revision of the existing MRLs for pome fruits, apricots, peaches and beans with pods. Information on storage temperature of samples from the feeding study and a validated analytical method for animal commodities were submitted. The two data gaps on animal commodities were satisfactorily addressed. Adequate analytical methods for enforcement are available to control the residues of pyridaben in plant matrices under consideration and in all animal matrices, where currently an limit of quantification (LOQ) of 0.02 mg/kg is considered at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of pyridaben according to the reported agricultural practices is unlikely to present a risk to consumer health. John Wiley and Sons Inc. 2023-04-17 /pmc/articles/PMC10108001/ /pubmed/37077298 http://dx.doi.org/10.2903/j.efsa.2023.7970 Text en © 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH 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
Bellisai, Giulia
Bernasconi, Giovanni
Brancato, Alba
Cabrera, Luis Carrasco
Castellan, Irene
Del Aguila, Monica
Ferreira, Lucien
Santonja, German Giner
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Robinson, Tobin
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Verani, Alessia
Evaluation of confirmatory data following Article 12 MRL review and modification of the existing MRLs in pome fruits for pyridaben
title Evaluation of confirmatory data following Article 12 MRL review and modification of the existing MRLs in pome fruits for pyridaben
title_full Evaluation of confirmatory data following Article 12 MRL review and modification of the existing MRLs in pome fruits for pyridaben
title_fullStr Evaluation of confirmatory data following Article 12 MRL review and modification of the existing MRLs in pome fruits for pyridaben
title_full_unstemmed Evaluation of confirmatory data following Article 12 MRL review and modification of the existing MRLs in pome fruits for pyridaben
title_short Evaluation of confirmatory data following Article 12 MRL review and modification of the existing MRLs in pome fruits for pyridaben
title_sort evaluation of confirmatory data following article 12 mrl review and modification of the existing mrls in pome fruits for pyridaben
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10108001/
https://www.ncbi.nlm.nih.gov/pubmed/37077298
http://dx.doi.org/10.2903/j.efsa.2023.7970
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