Reasoned opinion on the modification of the existing MRLs for dicamba in herbs and herbal infusions (leaves and flowers)

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta Agro S.A.S. to modify the existing MRLs for the active substance dicamba in herbs and herbal infusions (leaves and flowers)....

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Main Author: European Food Safety Authority
Format: Article
Language:English
Published: Wiley 2013-11-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2013.3470
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spelling doaj-fcdd296b9d5d42799ba349b7fac501472021-05-03T02:55:55ZengWileyEFSA Journal1831-47322013-11-011111n/an/a10.2903/j.efsa.2013.3470Reasoned opinion on the modification of the existing MRLs for dicamba in herbs and herbal infusions (leaves and flowers)European Food Safety AuthorityAbstract In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta Agro S.A.S. to modify the existing MRLs for the active substance dicamba in herbs and herbal infusions (leaves and flowers). In order to accommodate for the intended uses of dicamba, France proposed to raise the default MRL from the limit of quantification of 0.05* mg/kg to 4 mg/kg in herbs and 40 mg/kg in herbal infusions (leaves and flowers). France drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. EFSA concludes that the data are sufficient to derive a MRL proposal of 4 mg/kg for herbs. For herbal infusions (leaves) a MRL proposal of 40 mg/kg is derived by extrapolation from the residue trials conducted on oregano, considering a default dehydration factor of 10. Taking into account that the nature of the other crops classified in this group (hibiscus flowers, rose petals, jasmine flowers, elderflowers and lime) is not comparable, and that the notified GAP seems to be inappropriate for these crops, no MRL proposal is made for herbal infusions (flowers). A validated analytical enforcement method was submitted to control residues of dicamba in fresh herbs. For herbal infusions, a matrix which is considered as difficult to analyse, specific validation data should be provided. However, taking into account the successful validation in different matrix types, the analytical method is accepted on a provisional basis also for herbal infusion. Based on the risk assessment results, EFSA concludes that the proposed use of dicamba on herbs and herbal infusions (leaves) will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.https://doi.org/10.2903/j.efsa.2013.3470dicambaherbs and herbal infusionsMRL applicationRegulation (EC) No 396/2005consumer risk assessmentbenzoic acid herbicide
collection DOAJ
language English
format Article
sources DOAJ
author European Food Safety Authority
spellingShingle European Food Safety Authority
Reasoned opinion on the modification of the existing MRLs for dicamba in herbs and herbal infusions (leaves and flowers)
EFSA Journal
dicamba
herbs and herbal infusions
MRL application
Regulation (EC) No 396/2005
consumer risk assessment
benzoic acid herbicide
author_facet European Food Safety Authority
author_sort European Food Safety Authority
title Reasoned opinion on the modification of the existing MRLs for dicamba in herbs and herbal infusions (leaves and flowers)
title_short Reasoned opinion on the modification of the existing MRLs for dicamba in herbs and herbal infusions (leaves and flowers)
title_full Reasoned opinion on the modification of the existing MRLs for dicamba in herbs and herbal infusions (leaves and flowers)
title_fullStr Reasoned opinion on the modification of the existing MRLs for dicamba in herbs and herbal infusions (leaves and flowers)
title_full_unstemmed Reasoned opinion on the modification of the existing MRLs for dicamba in herbs and herbal infusions (leaves and flowers)
title_sort reasoned opinion on the modification of the existing mrls for dicamba in herbs and herbal infusions (leaves and flowers)
publisher Wiley
series EFSA Journal
issn 1831-4732
publishDate 2013-11-01
description Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta Agro S.A.S. to modify the existing MRLs for the active substance dicamba in herbs and herbal infusions (leaves and flowers). In order to accommodate for the intended uses of dicamba, France proposed to raise the default MRL from the limit of quantification of 0.05* mg/kg to 4 mg/kg in herbs and 40 mg/kg in herbal infusions (leaves and flowers). France drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. EFSA concludes that the data are sufficient to derive a MRL proposal of 4 mg/kg for herbs. For herbal infusions (leaves) a MRL proposal of 40 mg/kg is derived by extrapolation from the residue trials conducted on oregano, considering a default dehydration factor of 10. Taking into account that the nature of the other crops classified in this group (hibiscus flowers, rose petals, jasmine flowers, elderflowers and lime) is not comparable, and that the notified GAP seems to be inappropriate for these crops, no MRL proposal is made for herbal infusions (flowers). A validated analytical enforcement method was submitted to control residues of dicamba in fresh herbs. For herbal infusions, a matrix which is considered as difficult to analyse, specific validation data should be provided. However, taking into account the successful validation in different matrix types, the analytical method is accepted on a provisional basis also for herbal infusion. Based on the risk assessment results, EFSA concludes that the proposed use of dicamba on herbs and herbal infusions (leaves) will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.
topic dicamba
herbs and herbal infusions
MRL application
Regulation (EC) No 396/2005
consumer risk assessment
benzoic acid herbicide
url https://doi.org/10.2903/j.efsa.2013.3470
work_keys_str_mv AT europeanfoodsafetyauthority reasonedopiniononthemodificationoftheexistingmrlsfordicambainherbsandherbalinfusionsleavesandflowers
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