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Evaluation of confirmatory data following the Article 12 MRL review for S‐metolachlor

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for S‐metolachlor in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not avai...

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Autores principales: Bellisai, Giulia, Bernasconi, Giovanni, Carrasco Cabrera, Luis, Castellan, Irene, del Aguila, Monica, Ferreira, Lucien, Santonja, German Giner, Greco, Luna, Jarrah, Samira, Leuschner, Renata, Perez, Javier Martinez, Miron, Ileana, Nave, Stefanie, Pedersen, Ragnor, Reich, Hermine, Ruocco, Silvia, Santos, Miguel, Scarlato, Alessia Pia, Theobald, Anne, Tiramani, Manuela, 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/PMC10598600/
https://www.ncbi.nlm.nih.gov/pubmed/37886612
http://dx.doi.org/10.2903/j.efsa.2023.8374
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author Bellisai, Giulia
Bernasconi, Giovanni
Carrasco Cabrera, Luis
Castellan, Irene
del Aguila, Monica
Ferreira, Lucien
Santonja, German Giner
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Perez, Javier Martinez
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Tiramani, Manuela
Verani, Alessia
author_facet Bellisai, Giulia
Bernasconi, Giovanni
Carrasco Cabrera, Luis
Castellan, Irene
del Aguila, Monica
Ferreira, Lucien
Santonja, German Giner
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Perez, Javier Martinez
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Tiramani, Manuela
Verani, Alessia
collection PubMed
description The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for S‐metolachlor in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new freezer storage stability study for S‐metolachlor in commodities with high acid content was submitted. However, the data gap on storage stability was considered only partially addressed for strawberries because, in the absence of information on the storage time interval of the samples of the residue trials performed on strawberries, no conclusion on the validity of these trials could be drawn. The data gap on the lack of trials to support the good agricultural practice (GAP) on pineapples was not addressed. Consequently, the existing tentative MRLs for strawberries and pineapple cannot be confirmed and EFSA recommends lowering these MRLs to the enforcement limit of quantification (LOQ). Since a new lower LOQ for enforcement in high acid content commodities of 0.01 mg/kg has been validated, it is proposed to change the existing MRL value from 0.05* to 0.01* mg/kg for these two commodities.
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spelling pubmed-105986002023-10-26 Evaluation of confirmatory data following the Article 12 MRL review for S‐metolachlor Bellisai, Giulia Bernasconi, Giovanni Carrasco Cabrera, Luis Castellan, Irene del Aguila, Monica Ferreira, Lucien Santonja, German Giner Greco, Luna Jarrah, Samira Leuschner, Renata Perez, Javier Martinez Miron, Ileana Nave, Stefanie Pedersen, Ragnor Reich, Hermine Ruocco, Silvia Santos, Miguel Scarlato, Alessia Pia Theobald, Anne Tiramani, Manuela Verani, Alessia EFSA J Reasoned Opinion The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for S‐metolachlor in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new freezer storage stability study for S‐metolachlor in commodities with high acid content was submitted. However, the data gap on storage stability was considered only partially addressed for strawberries because, in the absence of information on the storage time interval of the samples of the residue trials performed on strawberries, no conclusion on the validity of these trials could be drawn. The data gap on the lack of trials to support the good agricultural practice (GAP) on pineapples was not addressed. Consequently, the existing tentative MRLs for strawberries and pineapple cannot be confirmed and EFSA recommends lowering these MRLs to the enforcement limit of quantification (LOQ). Since a new lower LOQ for enforcement in high acid content commodities of 0.01 mg/kg has been validated, it is proposed to change the existing MRL value from 0.05* to 0.01* mg/kg for these two commodities. John Wiley and Sons Inc. 2023-10-25 /pmc/articles/PMC10598600/ /pubmed/37886612 http://dx.doi.org/10.2903/j.efsa.2023.8374 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
Carrasco Cabrera, Luis
Castellan, Irene
del Aguila, Monica
Ferreira, Lucien
Santonja, German Giner
Greco, Luna
Jarrah, Samira
Leuschner, Renata
Perez, Javier Martinez
Miron, Ileana
Nave, Stefanie
Pedersen, Ragnor
Reich, Hermine
Ruocco, Silvia
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Tiramani, Manuela
Verani, Alessia
Evaluation of confirmatory data following the Article 12 MRL review for S‐metolachlor
title Evaluation of confirmatory data following the Article 12 MRL review for S‐metolachlor
title_full Evaluation of confirmatory data following the Article 12 MRL review for S‐metolachlor
title_fullStr Evaluation of confirmatory data following the Article 12 MRL review for S‐metolachlor
title_full_unstemmed Evaluation of confirmatory data following the Article 12 MRL review for S‐metolachlor
title_short Evaluation of confirmatory data following the Article 12 MRL review for S‐metolachlor
title_sort evaluation of confirmatory data following the article 12 mrl review for s‐metolachlor
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10598600/
https://www.ncbi.nlm.nih.gov/pubmed/37886612
http://dx.doi.org/10.2903/j.efsa.2023.8374
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