Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
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/PMC10358196/
https://www.ncbi.nlm.nih.gov/pubmed/37485252
http://dx.doi.org/10.2903/j.efsa.2023.8125
_version_ 1785075611976335360
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
work_keys_str_mv AT evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT bellisaigiulia evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT bernasconigiovanni evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT carrascocabreraluis evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT castellanirene evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT delaguilamonica evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT ferreiralucien evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT ginersantonjagerman evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT grecoluna evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT jarrahsamira evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT leuschnerrenata evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT perezjaviermartinez evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT mironileana evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT navestefanie evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT pedersenragnor evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT reichhermine evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT ruoccosilvia evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT santosmiguel evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT scarlatoalessiapia evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT theobaldanne evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT tiramanimanuela evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide
AT veranialessia evaluationofconfirmatorydatafollowingthearticle12mrlreviewfornapropamide