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Modification of existing maximum residue levels in various crops and evaluation of confirmatory data following the Article 12 MRL review for trifloxystrobin

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted two applications to the competent national authorities appointed in the United Kingdom and Greece to modify the existing maximum residue levels (MRLs) for the active substance trifloxystrobin in va...

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Autores principales: Bellisai, Giulia, Bernasconi, Giovanni, Brancato, Alba, Carrasco Cabrera, Luis, Ferreira, Lucien, Giner, German, Greco, Luna, Jarrah, Samira, Leuschner, Renata, Magrans, Jose Oriol, Miron, Ileana, Nave, Stefanie, Pedersen, Ragnor, Reich, Hermine, Ruocco, Silvia, Santos, Miguel, Scarlato, Alessia Pia, Theobald, Anne, Vagenende, Benedicte, Verani, Alessia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8771287/
https://www.ncbi.nlm.nih.gov/pubmed/35079285
http://dx.doi.org/10.2903/j.efsa.2022.7048
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author Bellisai, Giulia
Bernasconi, Giovanni
Brancato, Alba
Carrasco Cabrera, Luis
Ferreira, Lucien
Giner, German
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
author_facet Bellisai, Giulia
Bernasconi, Giovanni
Brancato, Alba
Carrasco Cabrera, Luis
Ferreira, Lucien
Giner, German
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
collection PubMed
description In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted two applications to the competent national authorities appointed in the United Kingdom and Greece to modify the existing maximum residue levels (MRLs) for the active substance trifloxystrobin in various crops and in sweet peppers/bell peppers, respectively. Moreover, in the application submitted to the United Kingdom, the applicant also included a request 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. In the framework of the assessment process, these applications were re‐allocated to the Netherlands. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for sweet peppers/bell peppers, kales, escaroles, herbs and edible flowers, beans with pods, oat and chicory roots. Since the data gaps identified in the MRL review were not addressed, risk managers might consider lowering the tentative MRLs in passion fruits/maracujas and leafy brassica other than kales to the limit of quantification (LOQ), and the implementation of the Codex MRL (CXL) in the EU legislation for cucumbers and gherkins. The new intended use on witloof/Belgian endives was not adequately supported by residue data and therefore an MRL proposal cannot be derived. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin on the commodities under consideration. Based on the results of the risk assessment performed, considering the exposure to residues of trifloxystrobin and its metabolites CGA 321113 (apart for passion fruits), EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of trifloxystrobin under consideration is unlikely to present a risk to consumer health, except for escaroles. For the intended indoor use on escaroles, a risk from short‐term intake cannot be excluded, hence a modification of the existing EU MRL is not proposed for this commodity. The consumer risk assessment shall be regarded as indicative and affected by uncertainties.
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spelling pubmed-87712872022-01-24 Modification of existing maximum residue levels in various crops and evaluation of confirmatory data following the Article 12 MRL review for trifloxystrobin Bellisai, Giulia Bernasconi, Giovanni Brancato, Alba Carrasco Cabrera, Luis Ferreira, Lucien Giner, German Greco, Luna Jarrah, Samira Leuschner, Renata Magrans, Jose Oriol Miron, Ileana Nave, Stefanie Pedersen, Ragnor Reich, Hermine Ruocco, Silvia Santos, Miguel Scarlato, Alessia Pia Theobald, Anne Vagenende, Benedicte Verani, Alessia EFSA J Reasoned Opinion In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted two applications to the competent national authorities appointed in the United Kingdom and Greece to modify the existing maximum residue levels (MRLs) for the active substance trifloxystrobin in various crops and in sweet peppers/bell peppers, respectively. Moreover, in the application submitted to the United Kingdom, the applicant also included a request 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. In the framework of the assessment process, these applications were re‐allocated to the Netherlands. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for sweet peppers/bell peppers, kales, escaroles, herbs and edible flowers, beans with pods, oat and chicory roots. Since the data gaps identified in the MRL review were not addressed, risk managers might consider lowering the tentative MRLs in passion fruits/maracujas and leafy brassica other than kales to the limit of quantification (LOQ), and the implementation of the Codex MRL (CXL) in the EU legislation for cucumbers and gherkins. The new intended use on witloof/Belgian endives was not adequately supported by residue data and therefore an MRL proposal cannot be derived. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin on the commodities under consideration. Based on the results of the risk assessment performed, considering the exposure to residues of trifloxystrobin and its metabolites CGA 321113 (apart for passion fruits), EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of trifloxystrobin under consideration is unlikely to present a risk to consumer health, except for escaroles. For the intended indoor use on escaroles, a risk from short‐term intake cannot be excluded, hence a modification of the existing EU MRL is not proposed for this commodity. The consumer risk assessment shall be regarded as indicative and affected by uncertainties. John Wiley and Sons Inc. 2022-01-20 /pmc/articles/PMC8771287/ /pubmed/35079285 http://dx.doi.org/10.2903/j.efsa.2022.7048 Text en © 2022 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
Bellisai, Giulia
Bernasconi, Giovanni
Brancato, Alba
Carrasco Cabrera, Luis
Ferreira, Lucien
Giner, German
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
Modification of existing maximum residue levels in various crops and evaluation of confirmatory data following the Article 12 MRL review for trifloxystrobin
title Modification of existing maximum residue levels in various crops and evaluation of confirmatory data following the Article 12 MRL review for trifloxystrobin
title_full Modification of existing maximum residue levels in various crops and evaluation of confirmatory data following the Article 12 MRL review for trifloxystrobin
title_fullStr Modification of existing maximum residue levels in various crops and evaluation of confirmatory data following the Article 12 MRL review for trifloxystrobin
title_full_unstemmed Modification of existing maximum residue levels in various crops and evaluation of confirmatory data following the Article 12 MRL review for trifloxystrobin
title_short Modification of existing maximum residue levels in various crops and evaluation of confirmatory data following the Article 12 MRL review for trifloxystrobin
title_sort modification of existing maximum residue levels in various crops and evaluation of confirmatory data following the article 12 mrl review for trifloxystrobin
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8771287/
https://www.ncbi.nlm.nih.gov/pubmed/35079285
http://dx.doi.org/10.2903/j.efsa.2022.7048
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