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Evaluation of confirmatory data following the Article 12 MRL review for napropamide
The applicant UPL Europe Ltd submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for napropamide in the framework of the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005 as not available. To ad...
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/PMC10358196/ https://www.ncbi.nlm.nih.gov/pubmed/37485252 http://dx.doi.org/10.2903/j.efsa.2023.8125 |
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author | Bellisai, Giulia Bernasconi, Giovanni Carrasco Cabrera, Luis Castellan, Irene Del Aguila, Monica Ferreira, Lucien Giner Santonja, German 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 Giner Santonja, German 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 UPL Europe Ltd submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for napropamide in the framework of the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new storage stability study on grapes (high acid content commodity) was submitted while a metabolism study in fruit crops following foliar treatment, residue trials on fresh herbs and edible flowers and an analytical method for matrices difficult to analyse were not submitted. Therefore, only the data gap for storage stability was satisfactorily addressed. The new information provided required a revision of the tentative MRLs for commodities where confirmatory data were indicated. An update of the consumer risk assessment for napropamide was performed considering the new data submitted and it did not indicate any consumer intake concerns in relation to the chronic exposure. |
format | Online Article Text |
id | pubmed-10358196 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-103581962023-07-21 Evaluation of confirmatory data following the Article 12 MRL review for napropamide Bellisai, Giulia Bernasconi, Giovanni Carrasco Cabrera, Luis Castellan, Irene Del Aguila, Monica Ferreira, Lucien Giner Santonja, German 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 UPL Europe Ltd submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for napropamide in the framework of the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new storage stability study on grapes (high acid content commodity) was submitted while a metabolism study in fruit crops following foliar treatment, residue trials on fresh herbs and edible flowers and an analytical method for matrices difficult to analyse were not submitted. Therefore, only the data gap for storage stability was satisfactorily addressed. The new information provided required a revision of the tentative MRLs for commodities where confirmatory data were indicated. An update of the consumer risk assessment for napropamide was performed considering the new data submitted and it did not indicate any consumer intake concerns in relation to the chronic exposure. John Wiley and Sons Inc. 2023-07-20 /pmc/articles/PMC10358196/ /pubmed/37485252 http://dx.doi.org/10.2903/j.efsa.2023.8125 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 Giner Santonja, German 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 napropamide |
title | Evaluation of confirmatory data following the Article 12 MRL review for napropamide |
title_full | Evaluation of confirmatory data following the Article 12 MRL review for napropamide |
title_fullStr | Evaluation of confirmatory data following the Article 12 MRL review for napropamide |
title_full_unstemmed | Evaluation of confirmatory data following the Article 12 MRL review for napropamide |
title_short | Evaluation of confirmatory data following the Article 12 MRL review for napropamide |
title_sort | evaluation of confirmatory data following the article 12 mrl review for napropamide |
topic | Reasoned Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10358196/ https://www.ncbi.nlm.nih.gov/pubmed/37485252 http://dx.doi.org/10.2903/j.efsa.2023.8125 |
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