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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
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.
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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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