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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2023
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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. |
format | Online Article Text |
id | pubmed-10598600 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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