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Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels in citrus fruits for imazalil.

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Title: Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels in citrus fruits for imazalil.
Authors: Leite, Sofia Batista (AUTHOR), Bellisai, Giulia (AUTHOR), Bernasconi, Giovanni (AUTHOR), Binaglia, Marco (AUTHOR), Cabrera, Luis Carrasco (AUTHOR), Castellan, Irene (AUTHOR), Castoldi, Anna Federica (AUTHOR), Chiusolo, Arianna (AUTHOR), Colas, Mathilde (AUTHOR), Crivellente, Federica (AUTHOR), Del Aguila, Monica (AUTHOR), Ferreira, Lucien (AUTHOR), Greco, Luna (AUTHOR), Istace, Frederique (AUTHOR), Jarrah, Samira (AUTHOR), Lanzoni, Anna (AUTHOR), Leuschner, Renata (AUTHOR), Louisse, Jochem (AUTHOR), Mangas, Iris (AUTHOR), Mioč, Andrea (AUTHOR)
Source: EFSA Journal. Aug2025, Vol. 23 Issue 8, p1-37. 37p.
Subject Terms: *Food safety, *Toxicology, *Agriculture, *Pesticides, Citrus fruits, Risk assessment, Food safety laws, European Union law
Company/Entity: European Food Safety Authority , Janssen Pharmaceutica NV
Abstract: The applicant Janssen Pharmaceutica N.V. submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for imazalil in the framework of the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005. In addition, a request for raising the MRL for citrus fruits was made. To address the data gaps additional information on the toxicity of the metabolites R014821, FK‐722 and FK‐284 and storage stability for imazalil and FK‐772 in ruminant matrices were submitted. The data gaps implemented in the MRL legislation were considered satisfactorily addressed with the information submitted in this application and in a previous MRL application on courgettes. The available residue data support the intended post‐harvest uses in citrus fruits and allow deriving an MRL proposal. The implementation of the Codex MRL for bananas and the maintenance of the existing tentative MRL for melons are proposed for risk management consideration. Based on the risk assessment results, noting that data on unit‐to‐unit variability of residues to refine the acute consumer risk assessment for citrus were provided, EFSA concluded that the short term and long‐term intake of residues resulting from the uses of imazalil according to the intended agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels in citrus fruits for imazalil.
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  Data: <searchLink fieldCode="AR" term="%22Leite%2C+Sofia+Batista%22">Leite, Sofia Batista</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bellisai%2C+Giulia%22">Bellisai, Giulia</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bernasconi%2C+Giovanni%22">Bernasconi, Giovanni</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Binaglia%2C+Marco%22">Binaglia, Marco</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cabrera%2C+Luis+Carrasco%22">Cabrera, Luis Carrasco</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Castellan%2C+Irene%22">Castellan, Irene</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Castoldi%2C+Anna+Federica%22">Castoldi, Anna Federica</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Chiusolo%2C+Arianna%22">Chiusolo, Arianna</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Colas%2C+Mathilde%22">Colas, Mathilde</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Crivellente%2C+Federica%22">Crivellente, Federica</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Del+Aguila%2C+Monica%22">Del Aguila, Monica</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ferreira%2C+Lucien%22">Ferreira, Lucien</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Greco%2C+Luna%22">Greco, Luna</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Istace%2C+Frederique%22">Istace, Frederique</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Jarrah%2C+Samira%22">Jarrah, Samira</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lanzoni%2C+Anna%22">Lanzoni, Anna</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Leuschner%2C+Renata%22">Leuschner, Renata</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Louisse%2C+Jochem%22">Louisse, Jochem</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mangas%2C+Iris%22">Mangas, Iris</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mioč%2C+Andrea%22">Mioč, Andrea</searchLink> (AUTHOR)
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  Data: The applicant Janssen Pharmaceutica N.V. submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for imazalil in the framework of the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005. In addition, a request for raising the MRL for citrus fruits was made. To address the data gaps additional information on the toxicity of the metabolites R014821, FK‐722 and FK‐284 and storage stability for imazalil and FK‐772 in ruminant matrices were submitted. The data gaps implemented in the MRL legislation were considered satisfactorily addressed with the information submitted in this application and in a previous MRL application on courgettes. The available residue data support the intended post‐harvest uses in citrus fruits and allow deriving an MRL proposal. The implementation of the Codex MRL for bananas and the maintenance of the existing tentative MRL for melons are proposed for risk management consideration. Based on the risk assessment results, noting that data on unit‐to‐unit variability of residues to refine the acute consumer risk assessment for citrus were provided, EFSA concluded that the short term and long‐term intake of residues resulting from the uses of imazalil according to the intended agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.2903/j.efsa.2025.9614
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