Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1783667838564696064 |
---|---|
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. |
format | Online Article Text |
id | pubmed-7983034 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT anastassiadoumaria modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT bellisaigiulia modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT bernasconigiovanni modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT brancatoalba modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT carrascocabreraluis modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT ferreiralucien modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT grecoluna modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT jarrahsamira modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT kazocinaaija modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT leuschnerrenata modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT magransjoseoriol modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT mironileana modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT navestefanie modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT pedersenragnor modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT reichhermine modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT santosmiguel modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT scarlatoalessiapia modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT theobaldanne modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT vagenendebenedicte modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac AT veranialessia modificationoftheexistingmaximumresiduelevelforphenmediphaminceleriac |