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Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for metazachlor in various commodities
The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for active substance metazachlor in the framework of the review of maximum residue levels (MRLs) under Article 12 of Regulation (EC) No 396/2005 as...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008858/ https://www.ncbi.nlm.nih.gov/pubmed/32626119 http://dx.doi.org/10.2903/j.efsa.2019.5819 |
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author | Anastassiadou, Maria 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 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 | The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for active substance metazachlor in the framework of the review of maximum residue levels (MRLs) under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps identified during the MRL review were satisfactorily addressed for flowering brassica, head cabbages, kales and kohlrabies. The applicant no longer supported the uses on radishes, turnips, horseradishes and swedes assessed during the MRL review. In addition, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant submitted a request to modify the existing MRLs in turnips, swedes, horseradishes and leeks to reflect intended new uses. Nevertheless, the residue data submitted were not fully compliant with the currently applicable data requirements. For turnips, horseradishes and swedes, the applicant and the Netherlands requested EFSA to present the data and the deficiencies identified to allow risk managers to take an informed decision on the appropriate MRLs. A change of the existing MRLs for liver of swine and ruminants resulting from the authorised and intended uses of metazachlor is also proposed. EFSA updated the most recent consumer risk assessment for metazachlor and concluded that the long‐term and short‐term dietary intake is unlikely to present a risk to consumer health. |
format | Online Article Text |
id | pubmed-7008858 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70088582020-07-02 Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for metazachlor in various commodities Anastassiadou, Maria 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 The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for active substance metazachlor in the framework of the review of maximum residue levels (MRLs) under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps identified during the MRL review were satisfactorily addressed for flowering brassica, head cabbages, kales and kohlrabies. The applicant no longer supported the uses on radishes, turnips, horseradishes and swedes assessed during the MRL review. In addition, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant submitted a request to modify the existing MRLs in turnips, swedes, horseradishes and leeks to reflect intended new uses. Nevertheless, the residue data submitted were not fully compliant with the currently applicable data requirements. For turnips, horseradishes and swedes, the applicant and the Netherlands requested EFSA to present the data and the deficiencies identified to allow risk managers to take an informed decision on the appropriate MRLs. A change of the existing MRLs for liver of swine and ruminants resulting from the authorised and intended uses of metazachlor is also proposed. EFSA updated the most recent consumer risk assessment for metazachlor and concluded that the long‐term and short‐term dietary intake is unlikely to present a risk to consumer health. John Wiley and Sons Inc. 2019-10-15 /pmc/articles/PMC7008858/ /pubmed/32626119 http://dx.doi.org/10.2903/j.efsa.2019.5819 Text en © 2019 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 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 metazachlor in various commodities |
title | Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for metazachlor in various commodities |
title_full | Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for metazachlor in various commodities |
title_fullStr | Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for metazachlor in various commodities |
title_full_unstemmed | Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for metazachlor in various commodities |
title_short | Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for metazachlor in various commodities |
title_sort | evaluation of confirmatory data following the article 12 mrl review and modification of the existing maximum residue levels for metazachlor in various commodities |
topic | Reasoned Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008858/ https://www.ncbi.nlm.nih.gov/pubmed/32626119 http://dx.doi.org/10.2903/j.efsa.2019.5819 |
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