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Modification of the existing maximum residue level for phenmedipham in celeriac

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant UPL Europe Ltd. submitted an application to the competent national authority in Germany (evaluating Member State, EMS) to raise the existing maximum residue level (MRL) to 0.15 mg/kg for the active substance phenmedipham in c...

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Autores principales: Anastassiadou, Maria, Bellisai, Giulia, 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, 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/PMC7983034/
https://www.ncbi.nlm.nih.gov/pubmed/33777235
http://dx.doi.org/10.2903/j.efsa.2021.6482
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author Anastassiadou, Maria
Bellisai, Giulia
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
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
author_facet Anastassiadou, Maria
Bellisai, Giulia
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
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 UPL Europe Ltd. submitted an application to the competent national authority in Germany (evaluating Member State, EMS) to raise the existing maximum residue level (MRL) to 0.15 mg/kg for the active substance phenmedipham in celeriac. The submitted residue trials are sufficient to derive a tentative MRL of 0.15 mg/kg, pending further investigation of nature of phenmedipham residues in root crops. For this assessment EFSA considered that the available sugar beet metabolism data can be extrapolated to celeriac on a tentative basis. The acceptability of such proposal shall be further considered by risk managers. Adequate analytical methods for enforcement are available to control the residues of phenmedipham in celeriac at the validated limit of quantification (LOQ) of 0.01 mg/kg. Since the current MRL application was submitted before the finalisation of the EU pesticides peer review of the renewal of the approval of phenmedipham, the consumer exposure assessment was performed according to the conclusions on the toxicity of phenmedipham from the first approval under Directive 91/414/EEC. Accordingly, the long‐term intake of residues of phenmedipham resulting from the existing and the intended uses does not indicate a risk to consumer health. The present assessment does not consider the data gaps identified in the context of the renewal of the approval of phenmedipham under Regulation (EC) No 1107/2009 which prevented experts to derive toxicological reference values (TRVs) for phenmedipham, to derive the risk assessment residue definition for root crops other than sugar beet and to conclude on the toxicity of relevant metabolites.
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spelling pubmed-79830342021-03-25 Modification of the existing maximum residue level for phenmedipham in celeriac Anastassiadou, Maria Bellisai, Giulia 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 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 UPL Europe Ltd. submitted an application to the competent national authority in Germany (evaluating Member State, EMS) to raise the existing maximum residue level (MRL) to 0.15 mg/kg for the active substance phenmedipham in celeriac. The submitted residue trials are sufficient to derive a tentative MRL of 0.15 mg/kg, pending further investigation of nature of phenmedipham residues in root crops. For this assessment EFSA considered that the available sugar beet metabolism data can be extrapolated to celeriac on a tentative basis. The acceptability of such proposal shall be further considered by risk managers. Adequate analytical methods for enforcement are available to control the residues of phenmedipham in celeriac at the validated limit of quantification (LOQ) of 0.01 mg/kg. Since the current MRL application was submitted before the finalisation of the EU pesticides peer review of the renewal of the approval of phenmedipham, the consumer exposure assessment was performed according to the conclusions on the toxicity of phenmedipham from the first approval under Directive 91/414/EEC. Accordingly, the long‐term intake of residues of phenmedipham resulting from the existing and the intended uses does not indicate a risk to consumer health. The present assessment does not consider the data gaps identified in the context of the renewal of the approval of phenmedipham under Regulation (EC) No 1107/2009 which prevented experts to derive toxicological reference values (TRVs) for phenmedipham, to derive the risk assessment residue definition for root crops other than sugar beet and to conclude on the toxicity of relevant metabolites. John Wiley and Sons Inc. 2021-03-22 /pmc/articles/PMC7983034/ /pubmed/33777235 http://dx.doi.org/10.2903/j.efsa.2021.6482 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
Bellisai, Giulia
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
Santos, Miguel
Scarlato, Alessia Pia
Theobald, Anne
Vagenende, Benedicte
Verani, Alessia
Modification of the existing maximum residue level for phenmedipham in celeriac
title Modification of the existing maximum residue level for phenmedipham in celeriac
title_full Modification of the existing maximum residue level for phenmedipham in celeriac
title_fullStr Modification of the existing maximum residue level for phenmedipham in celeriac
title_full_unstemmed Modification of the existing maximum residue level for phenmedipham in celeriac
title_short Modification of the existing maximum residue level for phenmedipham in celeriac
title_sort modification of the existing maximum residue level for phenmedipham in celeriac
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983034/
https://www.ncbi.nlm.nih.gov/pubmed/33777235
http://dx.doi.org/10.2903/j.efsa.2021.6482
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