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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2023
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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. |
format | Online Article Text |
id | pubmed-10108001 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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