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Modification of the existing maximum residue levels for difenoconazole in leafy brassica

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in commodities belonging to t...

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Autores principales: Anastassiadou, Maria, Bernasconi, Giovanni, Brancato, Alba, Carrasco Cabrera, Luis, Ferreira, Lucien, Greco, Luna, Jarrah, Samira, Kazocina, Aija, Leuschner, Renata, Magrans, Jose Oriol, Miron, Ileana, Nave, Stefanie, Pedersen, Ragnor, Reich, Hermine, Rojas, Alejandro, Sacchi, Angela, Santos, Miguel, Scarlato, Alessia Pia, Theobald, Anne, Vagenende, Benedicte, Verani, Alessia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7871204/
https://www.ncbi.nlm.nih.gov/pubmed/33603896
http://dx.doi.org/10.2903/j.efsa.2021.6407
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author Anastassiadou, Maria
Bernasconi, Giovanni
Brancato, Alba
Carrasco Cabrera, Luis
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Rojas, Alejandro
Sacchi, Angela
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
author_facet Anastassiadou, Maria
Bernasconi, Giovanni
Brancato, Alba
Carrasco Cabrera, Luis
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Rojas, Alejandro
Sacchi, Angela
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 Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in commodities belonging to the group of leafy brassica. The data submitted in support of the request were found to be sufficient to derive MRL proposals for leafy brassica. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in plant matrices under consideration at the validated LOQ of 0.01 mg/kg and for difenoconazole and metabolite CGA205375 in animal matrices at the validated LOQ of 0.01 mg/kg for meat muscle, fat, liver, kidney and eggs and at the validated LOQ of 0.005 mg/kg for milk. Based on the risk assessment results, EFSA concluded that for the crops assessed in this application the short‐term intake of residues resulting from the use of difenoconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. Long‐term consumer intake concerns cannot be excluded for the intended and existing difenoconazole uses as they are affected by uncertainties associated with the toxicity of metabolite CGA205375 and the lack of information on all existing difenoconazole uses in the EU. Overall, this risk assessment is considered provisional, pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and has to be re‐considered when the missing data become available. Additionally, this assessment does not take into consideration triazole derivative metabolites (TDMs) which may be generated by several pesticides belonging to the group of triazole fungicides as this application was submitted before September 2019 which is the date of application of the new strategy endorsed by the risk managers for the assessment of TDMs.
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spelling pubmed-78712042021-02-17 Modification of the existing maximum residue levels for difenoconazole in leafy brassica Anastassiadou, Maria Bernasconi, Giovanni Brancato, Alba Carrasco Cabrera, Luis Ferreira, Lucien Greco, Luna Jarrah, Samira Kazocina, Aija Leuschner, Renata Magrans, Jose Oriol Miron, Ileana Nave, Stefanie Pedersen, Ragnor Reich, Hermine Rojas, Alejandro Sacchi, Angela 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 Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in commodities belonging to the group of leafy brassica. The data submitted in support of the request were found to be sufficient to derive MRL proposals for leafy brassica. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in plant matrices under consideration at the validated LOQ of 0.01 mg/kg and for difenoconazole and metabolite CGA205375 in animal matrices at the validated LOQ of 0.01 mg/kg for meat muscle, fat, liver, kidney and eggs and at the validated LOQ of 0.005 mg/kg for milk. Based on the risk assessment results, EFSA concluded that for the crops assessed in this application the short‐term intake of residues resulting from the use of difenoconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. Long‐term consumer intake concerns cannot be excluded for the intended and existing difenoconazole uses as they are affected by uncertainties associated with the toxicity of metabolite CGA205375 and the lack of information on all existing difenoconazole uses in the EU. Overall, this risk assessment is considered provisional, pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and has to be re‐considered when the missing data become available. Additionally, this assessment does not take into consideration triazole derivative metabolites (TDMs) which may be generated by several pesticides belonging to the group of triazole fungicides as this application was submitted before September 2019 which is the date of application of the new strategy endorsed by the risk managers for the assessment of TDMs. John Wiley and Sons Inc. 2021-02-09 /pmc/articles/PMC7871204/ /pubmed/33603896 http://dx.doi.org/10.2903/j.efsa.2021.6407 Text en © 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://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
Anastassiadou, Maria
Bernasconi, Giovanni
Brancato, Alba
Carrasco Cabrera, Luis
Ferreira, Lucien
Greco, Luna
Jarrah, Samira
Kazocina, Aija
Leuschner, Renata
Magrans, Jose Oriol
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Rojas, Alejandro
Sacchi, Angela
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
Modification of the existing maximum residue levels for difenoconazole in leafy brassica
title Modification of the existing maximum residue levels for difenoconazole in leafy brassica
title_full Modification of the existing maximum residue levels for difenoconazole in leafy brassica
title_fullStr Modification of the existing maximum residue levels for difenoconazole in leafy brassica
title_full_unstemmed Modification of the existing maximum residue levels for difenoconazole in leafy brassica
title_short Modification of the existing maximum residue levels for difenoconazole in leafy brassica
title_sort modification of the existing maximum residue levels for difenoconazole in leafy brassica
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7871204/
https://www.ncbi.nlm.nih.gov/pubmed/33603896
http://dx.doi.org/10.2903/j.efsa.2021.6407
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