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Modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Certis Europe B.V. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance imazalil in cucumbers, courgettes and gherkins. The d...

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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/PMC10114095/
https://www.ncbi.nlm.nih.gov/pubmed/37089184
http://dx.doi.org/10.2903/j.efsa.2023.7980
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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 Certis Europe B.V. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance imazalil in cucumbers, courgettes and gherkins. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 0.08 mg/kg for the whole group of cucurbits with edible peel. It is noted that the derived MRL is proposed to replace the existing tentative MRL of 0.1 mg/kg for courgettes, thus also addressing the data gap identified in the context of the MRL review. As regards to cucumbers and gherkins, it is noted that the MRL proposal derived in the current application is covered by the MRL of 0.5 mg/kg currently in place for these commodities. Nevertheless, it is also noted that the aforementioned MRLs are based on Codex maximum residue limits (CXLs) which were revoked in 2019 following the JMPR proposal. Should this proposal be implemented in the EU regulation in the future, the proposed MRL of 0.08 mg/kg as derived in the current application would be considered an appropriate fall‐back option for the whole group of cucurbits with edible peel. Further risk management considerations are therefore required. Adequate analytical methods for enforcement are available to control the residues of imazalil on the commodities under consideration at the validated limit of quantification (LOQ) of 0.005 mg/kg (QuEChERS method based on LC–MS/MS) and 0.01 mg/kg (HPLC–MS/MS method). Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of imazalil according to the reported agricultural practices is unlikely to present a risk to consumer health. However, it should be noted that a high degree of uncertainty on the overall long‐term exposure calculation remains due to the data gaps identified in the context of the MRL review on full toxicological assessment of the metabolite R014821, which is expected to occur following post‐harvest uses of imazalil, and animal metabolites FK‐772 and FK‐284.
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spelling pubmed-101140952023-04-20 Modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins 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 Certis Europe B.V. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance imazalil in cucumbers, courgettes and gherkins. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 0.08 mg/kg for the whole group of cucurbits with edible peel. It is noted that the derived MRL is proposed to replace the existing tentative MRL of 0.1 mg/kg for courgettes, thus also addressing the data gap identified in the context of the MRL review. As regards to cucumbers and gherkins, it is noted that the MRL proposal derived in the current application is covered by the MRL of 0.5 mg/kg currently in place for these commodities. Nevertheless, it is also noted that the aforementioned MRLs are based on Codex maximum residue limits (CXLs) which were revoked in 2019 following the JMPR proposal. Should this proposal be implemented in the EU regulation in the future, the proposed MRL of 0.08 mg/kg as derived in the current application would be considered an appropriate fall‐back option for the whole group of cucurbits with edible peel. Further risk management considerations are therefore required. Adequate analytical methods for enforcement are available to control the residues of imazalil on the commodities under consideration at the validated limit of quantification (LOQ) of 0.005 mg/kg (QuEChERS method based on LC–MS/MS) and 0.01 mg/kg (HPLC–MS/MS method). Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of imazalil according to the reported agricultural practices is unlikely to present a risk to consumer health. However, it should be noted that a high degree of uncertainty on the overall long‐term exposure calculation remains due to the data gaps identified in the context of the MRL review on full toxicological assessment of the metabolite R014821, which is expected to occur following post‐harvest uses of imazalil, and animal metabolites FK‐772 and FK‐284. John Wiley and Sons Inc. 2023-04-19 /pmc/articles/PMC10114095/ /pubmed/37089184 http://dx.doi.org/10.2903/j.efsa.2023.7980 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
Modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins
title Modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins
title_full Modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins
title_fullStr Modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins
title_full_unstemmed Modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins
title_short Modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins
title_sort modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10114095/
https://www.ncbi.nlm.nih.gov/pubmed/37089184
http://dx.doi.org/10.2903/j.efsa.2023.7980
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