Reasoned opinion on the modification of the existing MRLs for tebuconazole in cucumbers and courgettes

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(1):4000 [24 pp.].
doi
10.2903/j.efsa.2015.4000
Type
Reasoned Opinion
On request from
European Commission
Question Number
No EFSA-Q-2014-00601
Approved
20 January 2015
Published
30 January 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, hereafter referred to as the evaluating Member State (EMS), received an application from Oxon Italia S.p.A. to modify the existing MRLs for the active substance tebuconazole in cucumbers and courgettes. In order to accommodate for the intended uses of tebuconazole, Italy proposed to raise the MRL from 0.2 mg/kg to 0.5 mg/kg. Italy 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. According to EFSA the data are sufficient to derive an MRL proposal of 0.6 mg/kg for the proposed uses on cucumbers and courgettes. Adequate analytical enforcement methods are available to control the residues of tebuconazole in the plant matrices under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of tebuconazole on cucumbers and courgettes will not result in a consumer exposure exceeding the toxicological reference values.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, hereafter referred to as the evaluating Member State (EMS), received an application from Oxon Italia S.p.A. to modify the existing MRLs for the active substance tebuconazole in cucumbers and courgettes. In order to accommodate for the intended uses of tebuconazole, Italy proposed to raise the MRL from 0.2 mg/kg to 0.5 mg/kg. Italy 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 on 1 September 2014. 

EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) and its addenda prepared under Council Directive 91/414/EEC, the Commission Review Report, the conclusion on the peer review of the pesticide risk assessment of the active substance tebuconazole, the JMPR Evaluation reports as well as the conclusions from previous EFSA opinions on tebuconazole.

The toxicological profile of tebuconazole was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to propose an ADI of 0.03 mg/kg bw per day and an ARfD of 0.03 mg/kg bw.

The metabolism of tebuconazole in primary crops was investigated in the cereal (wheat), oilseed (peanut) and fruit crop groups (grape). From these studies the residue definition for monitoring was provisionally proposed as tebuconazole (sum of enantiomers), pending the outcome of a global risk assessment approach for triazole derivative metabolites (TMDs). For risk assessment, the residue definition was proposed as tebuconazole (sum of enantiomers), but it was highlighted that an additional separate residue definition is needed for TDMs, harmonised for all active substances of the triazole chemical class. 

EFSA concludes that the submitted supervised residue trials are sufficient to derive an MRL proposal of 0.6 mg/kg for the proposed uses on cucumbers and courgettes. Adequate analytical enforcement methods are available to control the residues of tebuconazole in the plant matrices under consideration at the validated LOQ of 0.02 mg/kg.

Specific studies investigating the magnitude of tebuconazole residues in processed commodities were not provided and are not required, as the contribution of the residues in cucumbers and courgettes to overall dietary consumer exposure is low.

Based on the available information, EFSA concluded that residues of tebuconazole are not expected to be present in significant levels in rotational crops when the active substance is applied on cucumbers and courgettes according to the proposed GAPs. In contrast, the magnitude of the TDMs residues in rotational crops could not be addressed.

Residues of tebuconazole in commodities of animal origin were not assessed in the framework of this application, since the crops under consideration are not fed to livestock.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). In the framework of the Article 12 MRL review, a comprehensive acute and long-term exposure assessment was performed, taking into account all existing uses of tebuconazole at EU level. EFSA now updates this risk assessment considering the median and highest residue values derived from the residue trials conducted on courgettes and cucumbers and the median and highest residue values reported in EFSA reasoned opinions issued after Article 12 review. Codex values (CXLx) implemented in the EU legislation were also taken into account.

No long term consumer intake concern was identified. The maximum International Estimated Daily Intake (IEDI) was calculated to be 15 % of the ADI (WHO cluster B). The contribution of tebuconazole residues in cucumbers and courgettes the overall dietary exposure, was estimated to be 0.4 % and 0.2 % of the ADI, respectively. No short term consumer intake concern was identified. The maximum International Estimated Short Term Intake (IESTI) was calculated to be 57 % of the ARfD for cucumbers (NL Child).

However, EFSA emphasises that the above assessment does not take into consideration triazole derivative metabolites. Since these metabolites may be generated by several pesticides belonging to the group of triazole fungicides, EFSA recommends that a separate risk assessment should be performed for TDMs as soon as the confirmatory data requested for triazole compounds in the framework of Regulation (EC) No 1107/2009 have been evaluated and a general methodology on the risk assessment of triazole compounds and their triazole derivative metabolites is available.

EFSA concludes that the proposed use of tebuconazole on cucumbers and courgettes will not result in a consumer exposure exceeding the toxicological reference values and therefore, is unlikely to pose a consumer health risk. Thus EFSA proposes to amend the existing MRLs as reported in the summary table.

Keywords
tebuconazole, cucumbers and courgettes, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, triazole, triazole derivative metabolites
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Number of Pages
24