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

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Article
EFSA Journal 2012;10(6):2793 [25 pp.].
doi
10.2903/j.efsa.2012.2793
European Food Safety Authority
Type
Reasoned Opinion
On Request From
European Commission
Question Number
EFSA-Q-2009-00364
Approved
25 June 2012
Published
27 June 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (491.49 KB)491.49 KB
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, herewith referred to as the evaluating Member State (EMS), compiled an application to modify the existing MRLs for tebufenpyrad in cucumbers and courgettes. In order to accommodate for the intended indoor and outdoor use of tebufenpyrad in southern and northern Europe, the EMS proposed to raise the existing MRLs in cucumbers and courgettes from 0.1 mg/kg to 0.3 mg/kg. The EMS drafted an evaluation report according to 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 a MRL proposal of 0.3 mg/kg for the proposed indoor and SEU outdoor uses on cucumbers and courgettes. The intended outdoor NEU use is not sufficiently supported by residue data. Based on the risk assessment results, EFSA concludes that the intended indoor use of tebufenpyrad on cucumbers and courgettes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, herewith referred to as the evaluating Member State (EMS), compiled an application to modify the existing MRLs for tebufenpyrad in cucumbers and courgettes. In order to accommodate for the intended indoor and outdoor use of tebufenpyrad in southern and northern Europe, the EMS proposed to raise the existing MRLs in cucumbers and courgettes from 0.1 mg/kg to 0.3 mg/kg. The EMS drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 30 January 2009. On 23 April 2009 some data requirements were identified, which prevented EFSA to conclude on the consumer risk assessment. An updated evaluation report, addressing those data requirements, was submitted by the EMS on 27 March 2012 and taken into consideration by EFSA for finalization of this reasoned opinion.

EFSA bases its assessment on the updated evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the conclusion on the peer review of the pesticide risk assessment of the active substance tebufenpyrad and the conclusions of the previously issued EFSA reasoned opinion on the modification of the existing MRLs for tebufenpyrad.

The toxicological profile of tebufenpyrad was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.01 mg/kg bw per day and an ARfD of 0.02 mg/kg bw.

The metabolism of tebufenpyrad in primary crops was investigated in apples only, representing the crop group of fruits and fruiting vegetables. From these studies the peer review concluded to establish the residue definition for enforcement and risk assessment as parent tebufenpyrad. For the use on the crops under consideration EFSA concludes that the metabolism of tebufenpyrad is sufficiently addressed and that the derived residue definitions are applicable. Adequate analytical enforcement methods are available to control the residues of tebufenpyrad in the crops under consideration.

EFSA considers that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.3 mg/kg for the proposed indoor and SEU outdoor uses on cucumbers and courgettes. The intended outdoor NEU use is not sufficiently supported by residue data.

Studies investigating the nature of tebufenpyrad residues in processed commodities were assessed in the framework of the peer review and showed that the compound is hydrolytically stable. Therefore for processed commodities the same residue definition as for raw agricultural commodities is applicable. Studies investigating the magnitude of tebufenpyrad residues in processed cucumbers and courgettes are not available. Considering the high calculated consumer exposure to tebufenpyrad residues, processing studies would be desirable with the crops that contribute significantly to the total dietary exposure (apples, oranges).

Cucumbers and courgettes can be grown in a crop rotation. The studies demonstrated that the soil degradation rate of tebufenpyrad and its metabolite CL 810 721 exceeds the DT90 trigger value of 100 days. Metabolite CL 810 721 has been observed also in rat metabolism and some toxicological studies that have been performed in the framework of the peer review indicate that the metabolite is of the same or lower toxicity than parent tebufenpyrad. Lacking studies on the nature and magnitude of tebufenpyrad related residues in rotational/succeeding crops EFSA can not estimate if and in which concentration residues resulting from the use of tebufenpyrad on primary crops occur in rotational crops. Consequently, the risk assessment for rotational crops cannot be finalised. EFSA therefore recommends that Member States granting new authorisations for tebufenpyrad define appropriate restrictions in order to avoid contamination of rotational crops.

Residues of tebufenpyrad in commodities of animal origin were not assessed in the framework of this application, since cucumbers and courgettes are normally not fed to livestock.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). It is noted that in this risk assessment the possible occurrence of residues in rotational/succeeding crops resulting from the use of tebufenpyrad on primary crops could not be considered since the relevant studies are not available at the moment. For the calculation of the chronic exposure, EFSA used the median residue value as derived from the outdoor residue trials on cucumbers; the same value was used as an input value for courgettes. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annex IIIA of Regulation (EC) No 396/2005 were used as input values. The acute exposure assessment was performed only with regard to cucumbers and courgettes, assuming the consumption of a large portion of the food items as reported in the national food surveys containing residues at the highest level as observed in supervised field trials.

The estimated exposure was then compared with the toxicological reference values derived for tebufenpyrad.

No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 87.9% of the ADI (maximum for DE child diet). The contribution of residues in the crops under consideration to the total consumer exposure (in percentage of the ADI) accounted for a maximum of 1.31% for cucumbers (DK child diet) and 0.54 % for courgettes (FR infant diet).

No acute consumer risk was identified in relation to the MRL proposals for the crops under consideration. The calculated maximum exposure in percentage of the ARfD was 55% for cucumbers and 44% for courgettes.

EFSA concludes that the intended indoor use of tebufenpyrad on cucumbers and courgettes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.

Keywords
Tebufenpyrad, cucumbers, courgettes, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, pyrazole insecticide and acaricide
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Number of Pages
25