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Modification of the existing maximum residue levels for acibenzolar‐S‐methyl in beans with pods and peas with pods

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France SAS submitted a request to the competent national authority in France to amend the residue definition for risk assessment and to modify the existing maximum residue levels (MRLs) for the active substance acibe...

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Autores principales: 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
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/PMC7908853/
https://www.ncbi.nlm.nih.gov/pubmed/33680135
http://dx.doi.org/10.2903/j.efsa.2021.6430
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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 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France SAS submitted a request to the competent national authority in France to amend the residue definition for risk assessment and to modify the existing maximum residue levels (MRLs) for the active substance acibenzolar‐S‐methyl in beans (with pods) and peas (with pods). The toxicological data submitted in support of this MRL application were found to be sufficient to conclude that the plant metabolite 4‐OH acibenzolar acid is not genotoxic in vitro, however lacking investigation of the general toxicity, a definitive conclusion cannot be derived whether 4‐OH acibenzolar acid (free and conjugated) should be included or excluded from the residue definition for risk assessment for all commodities belonging to the groups of leafy crops and pulses/oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals on the basis of the current residue definition (sum of acibenzolar‐S‐methyl and acibenzolar acid (free and conjugated), expressed as acibenzolar‐S‐methyl) for the intended uses on lettuces and salad plants, beans (with pods) and peas (with pods). The available residue trials are sufficient to derive MRL proposals of 1 mg/kg for beans with pods and peas with pods. The submitted information did not provide evidence that the existing MRL has to be changed for the intended uses on lettuces and other salad plants. For herbs and edible flowers, data gaps were identified which precluded the derivation of MRL proposals. The consumer risk assessment for the current residue definition did not identify an unacceptable risk for consumers. The indicative exposure calculations performed for the metabolite 4‐OH acibenzolar indicate that exposure to this metabolite is lower than the exposure to acibenzolar‐S‐methyl and acibenzolar acid (free and conjugated). However, considering the data gaps identified, a definitive conclusion cannot be derived by EFSA on the risk for consumers related to the intake of residues of 4‐OH acibenzolar acid. The reliable end points appropriate for use in regulatory risk assessment are presented.
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spelling pubmed-79088532021-03-05 Modification of the existing maximum residue levels for acibenzolar‐S‐methyl in beans with pods and peas with pods 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 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France SAS submitted a request to the competent national authority in France to amend the residue definition for risk assessment and to modify the existing maximum residue levels (MRLs) for the active substance acibenzolar‐S‐methyl in beans (with pods) and peas (with pods). The toxicological data submitted in support of this MRL application were found to be sufficient to conclude that the plant metabolite 4‐OH acibenzolar acid is not genotoxic in vitro, however lacking investigation of the general toxicity, a definitive conclusion cannot be derived whether 4‐OH acibenzolar acid (free and conjugated) should be included or excluded from the residue definition for risk assessment for all commodities belonging to the groups of leafy crops and pulses/oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals on the basis of the current residue definition (sum of acibenzolar‐S‐methyl and acibenzolar acid (free and conjugated), expressed as acibenzolar‐S‐methyl) for the intended uses on lettuces and salad plants, beans (with pods) and peas (with pods). The available residue trials are sufficient to derive MRL proposals of 1 mg/kg for beans with pods and peas with pods. The submitted information did not provide evidence that the existing MRL has to be changed for the intended uses on lettuces and other salad plants. For herbs and edible flowers, data gaps were identified which precluded the derivation of MRL proposals. The consumer risk assessment for the current residue definition did not identify an unacceptable risk for consumers. The indicative exposure calculations performed for the metabolite 4‐OH acibenzolar indicate that exposure to this metabolite is lower than the exposure to acibenzolar‐S‐methyl and acibenzolar acid (free and conjugated). However, considering the data gaps identified, a definitive conclusion cannot be derived by EFSA on the risk for consumers related to the intake of residues of 4‐OH acibenzolar acid. The reliable end points appropriate for use in regulatory risk assessment are presented. John Wiley and Sons Inc. 2021-02-26 /pmc/articles/PMC7908853/ /pubmed/33680135 http://dx.doi.org/10.2903/j.efsa.2021.6430 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
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
Modification of the existing maximum residue levels for acibenzolar‐S‐methyl in beans with pods and peas with pods
title Modification of the existing maximum residue levels for acibenzolar‐S‐methyl in beans with pods and peas with pods
title_full Modification of the existing maximum residue levels for acibenzolar‐S‐methyl in beans with pods and peas with pods
title_fullStr Modification of the existing maximum residue levels for acibenzolar‐S‐methyl in beans with pods and peas with pods
title_full_unstemmed Modification of the existing maximum residue levels for acibenzolar‐S‐methyl in beans with pods and peas with pods
title_short Modification of the existing maximum residue levels for acibenzolar‐S‐methyl in beans with pods and peas with pods
title_sort modification of the existing maximum residue levels for acibenzolar‐s‐methyl in beans with pods and peas with pods
topic Reasoned Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7908853/
https://www.ncbi.nlm.nih.gov/pubmed/33680135
http://dx.doi.org/10.2903/j.efsa.2021.6430
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