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Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for prothioconazole in celeriacs and rapeseeds
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Bayer SAS Crop Science and the Agriculture and Horticulture Development Board submitted two requests to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for prothioc...
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/PMC7448029/ https://www.ncbi.nlm.nih.gov/pubmed/32874214 http://dx.doi.org/10.2903/j.efsa.2020.5999 |
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author | Anastassiadou, Maria Bernasconi, Giovanni Brancato, Alba Carrasco Cabrera, Luis 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 Stanek, Alois Theobald, Anne Vagenende, Benedicte Verani, Alessia |
author_facet | Anastassiadou, Maria Bernasconi, Giovanni Brancato, Alba Carrasco Cabrera, Luis 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 Stanek, Alois Theobald, Anne Vagenende, Benedicte Verani, Alessia |
collection | PubMed |
description | In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Bayer SAS Crop Science and the Agriculture and Horticulture Development Board submitted two requests to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for prothioconazole in rapeseeds and celeriacs, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for these crops. The applicant Bayer SAS Crop Science additionally submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on carrots, onions, rapeseeds and wheat, and storage stability studies were submitted. The data gaps are considered fully addressed for the root and tuber vegetables, the oilseeds concerned and wheat. The data gaps have been partially addressed for onions, shallots, flowering brassica, Brussels sprouts, head cabbages, leeks, rye, barely and oat. The data gaps were not addressed for pulses and grass. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the existing and intended uses of prothioconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. For the triazole derivative metabolites (TDMs), only an indicative exposure assessment was performed considering celeriacs and rapeseeds; the results showed that the expected exposure to TDMs in these commodities is well below the toxicological reference values derived for the TDMs. |
format | Online Article Text |
id | pubmed-7448029 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-74480292020-08-31 Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for prothioconazole in celeriacs and rapeseeds Anastassiadou, Maria Bernasconi, Giovanni Brancato, Alba Carrasco Cabrera, Luis 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 Stanek, Alois Theobald, Anne Vagenende, Benedicte Verani, Alessia EFSA J Reasoned Opinion In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Bayer SAS Crop Science and the Agriculture and Horticulture Development Board submitted two requests to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for prothioconazole in rapeseeds and celeriacs, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for these crops. The applicant Bayer SAS Crop Science additionally submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on carrots, onions, rapeseeds and wheat, and storage stability studies were submitted. The data gaps are considered fully addressed for the root and tuber vegetables, the oilseeds concerned and wheat. The data gaps have been partially addressed for onions, shallots, flowering brassica, Brussels sprouts, head cabbages, leeks, rye, barely and oat. The data gaps were not addressed for pulses and grass. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the existing and intended uses of prothioconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. For the triazole derivative metabolites (TDMs), only an indicative exposure assessment was performed considering celeriacs and rapeseeds; the results showed that the expected exposure to TDMs in these commodities is well below the toxicological reference values derived for the TDMs. John Wiley and Sons Inc. 2020-02-21 /pmc/articles/PMC7448029/ /pubmed/32874214 http://dx.doi.org/10.2903/j.efsa.2020.5999 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 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 Stanek, Alois Theobald, Anne Vagenende, Benedicte Verani, Alessia Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for prothioconazole in celeriacs and rapeseeds |
title | Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for prothioconazole in celeriacs and rapeseeds |
title_full | Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for prothioconazole in celeriacs and rapeseeds |
title_fullStr | Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for prothioconazole in celeriacs and rapeseeds |
title_full_unstemmed | Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for prothioconazole in celeriacs and rapeseeds |
title_short | Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for prothioconazole in celeriacs and rapeseeds |
title_sort | evaluation of confirmatory data following the article 12 mrl review and modification of the existing maximum residue levels for prothioconazole in celeriacs and rapeseeds |
topic | Reasoned Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448029/ https://www.ncbi.nlm.nih.gov/pubmed/32874214 http://dx.doi.org/10.2903/j.efsa.2020.5999 |
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