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Evaluation of confirmatory data following the Article 12 MRL review and setting of import tolerances for bifenthrin in maize grain and sweet corn
The applicant FMC Agricultural Solutions A/S submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To addre...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7757675/ https://www.ncbi.nlm.nih.gov/pubmed/33376554 http://dx.doi.org/10.2903/j.efsa.2020.6361 |
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author | Anastassiadou, Maria 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 Rojas, Alejandro Sacchi, Angela Santos, Miguel Scarlato, Alessia Pia Theobald, Anne Vagenende, Benedicte Verani, Alessia |
author_facet | Anastassiadou, Maria 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 Rojas, Alejandro Sacchi, Angela Santos, Miguel Scarlato, Alessia Pia Theobald, Anne Vagenende, Benedicte Verani, Alessia |
collection | PubMed |
description | The applicant FMC Agricultural Solutions A/S submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified 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 storage stability study was submitted and information on an analytical method for determination of bifenthrin in eggs was made available. The data gaps were sufficiently addressed. The new information provided, did not require a revision of the existing MRLs. In addition, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant submitted a request to set import tolerances for bifenthrin in sweet corn and maize grain. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for maize grain only. For sweet corn, data gaps were identified which precluded the derivation of an MRL proposal. Adequate analytical methods for enforcement are available to control the residues of bifenthrin (sum of isomers) in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices. EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of bifenthrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment is affected by additional non‐standard uncertainty related to the expiry of EU authorisation for a number of crops for which previously EU MRLs were established, and which are still included in the risk assessment. |
format | Online Article Text |
id | pubmed-7757675 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-77576752020-12-28 Evaluation of confirmatory data following the Article 12 MRL review and setting of import tolerances for bifenthrin in maize grain and sweet corn Anastassiadou, Maria 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 Rojas, Alejandro Sacchi, Angela Santos, Miguel Scarlato, Alessia Pia Theobald, Anne Vagenende, Benedicte Verani, Alessia EFSA J Reasoned Opinion The applicant FMC Agricultural Solutions A/S submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified 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 storage stability study was submitted and information on an analytical method for determination of bifenthrin in eggs was made available. The data gaps were sufficiently addressed. The new information provided, did not require a revision of the existing MRLs. In addition, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant submitted a request to set import tolerances for bifenthrin in sweet corn and maize grain. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for maize grain only. For sweet corn, data gaps were identified which precluded the derivation of an MRL proposal. Adequate analytical methods for enforcement are available to control the residues of bifenthrin (sum of isomers) in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices. EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of bifenthrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment is affected by additional non‐standard uncertainty related to the expiry of EU authorisation for a number of crops for which previously EU MRLs were established, and which are still included in the risk assessment. John Wiley and Sons Inc. 2020-12-23 /pmc/articles/PMC7757675/ /pubmed/33376554 http://dx.doi.org/10.2903/j.efsa.2020.6361 Text en © 2020 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 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 Rojas, Alejandro Sacchi, Angela Santos, Miguel Scarlato, Alessia Pia Theobald, Anne Vagenende, Benedicte Verani, Alessia Evaluation of confirmatory data following the Article 12 MRL review and setting of import tolerances for bifenthrin in maize grain and sweet corn |
title | Evaluation of confirmatory data following the Article 12 MRL review and setting of import tolerances for bifenthrin in maize grain and sweet corn |
title_full | Evaluation of confirmatory data following the Article 12 MRL review and setting of import tolerances for bifenthrin in maize grain and sweet corn |
title_fullStr | Evaluation of confirmatory data following the Article 12 MRL review and setting of import tolerances for bifenthrin in maize grain and sweet corn |
title_full_unstemmed | Evaluation of confirmatory data following the Article 12 MRL review and setting of import tolerances for bifenthrin in maize grain and sweet corn |
title_short | Evaluation of confirmatory data following the Article 12 MRL review and setting of import tolerances for bifenthrin in maize grain and sweet corn |
title_sort | evaluation of confirmatory data following the article 12 mrl review and setting of import tolerances for bifenthrin in maize grain and sweet corn |
topic | Reasoned Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7757675/ https://www.ncbi.nlm.nih.gov/pubmed/33376554 http://dx.doi.org/10.2903/j.efsa.2020.6361 |
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