Reasoned opinion on the modification of the existing MRLs for tebuconazole in citrus (except oranges), lettuce and other salad plants, parsley and chives

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Article
EFSA Journal 2012;10(9):2898 [37 pp.].
doi
10.2903/j.efsa.2012.2898
European Food Safety Authority
Type
Reasoned Opinion
On Request From
European Commission
Question Number
EFSA-Q-2011-01023
EFSA-Q-2012-00610
EFSA-Q-2012-00779
Approved
24 Septembre 2012
Published
27 Septembre 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (716.18 KB)716.18 KB
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Spain received an application from Makhteshim Agan Espana, S.A. to modify the existing MRLs for the active substance tebuconazole in citrus fruit (except oranges). Spain also received an application from Bayer CropScience to modify the existing MRL for tebuconazole for lettuce and other salad plants including Brassicaceae. Germany received an application from the plant protection service LSA (Landesanstalt für Landwirtschaft, Forsten und Gartenbau Sachsen-Anhalt) to modify the MRLs for tebuconazole on parsley and chives. Spain and Germany drafted the evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA. For reasons of efficiency EFSA combined the three applications in one reasoned opinion. According to EFSA the data are sufficient to derive MRL proposals for the crops under consideration. Adequate analytical enforcement methods are available to control residues of tebuconazole on the commodities for which a MRL is proposed at the validated LOQ of 0.02 mg/kg. Based on the risk assessment results, EFSA concludes that the proposed uses of tebuconazole on citrus fruit (except oranges), lettuce and other salad plants including Brassicaceae, chives and parsley will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.

Summary

According to Article 6 of the Regulation (EC) No 396/2005, Spain, herewith referred as the evaluating Member State (EMS-ES), received an application from Makhteshim Agan Espana, S.A. to modify the existing MRLs for the active substance tebuconazole in citrus fruits (except oranges). In order to accommodate for the intended use of tebuconazole, Spain proposed to raise the existing MRL from 0.9 mg/kg to 5 mg/kg for grapefruit, lemons, limesand other citrus fruit (except oranges) and from 3 mg/kg to 5 mg/kg for mandarins. The EMS-ES drafted an evaluation report according to Article 8 of that regulation, which was submitted to the European Commission and forwarded to EFSA on 19 September 2011.

Spain also received an application from Bayer CropScience to modify the existing MRL for tebuconazole for lettuce and other salad plants including Brassicaceae. In order to accommodate for the intended use of tebuconazole, Spain proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.05 mg/kg to 0.5 mg/kg. Spain drafted an evaluation report which was submitted to the European Commission and forwarded to EFSA on 3 September 2012.

Germany, herewith referred to as the EMS-DE, received an application from the plant protection service LSA (Landesanstalt für Landwirtschaft, Forsten und Gartenbau Sachsen-Anhalt) to raise the existing MRLs for tebuconazole on parsley and chives to 2 mg/kg. The EMS-DE 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 16 April 2012.

For reasons of efficiency EFSA combined the three applications in one reasoned opinion. EFSA derives the following conclusions based on the submitted evaluation reports prepared by Spain and Germany, the Draft Assessment Report and its addendum prepared under Council Directive 91/414/EEC, the Commission Review Report on tebuconazole, the conclusion of EFSA on the peer review of the risk assessment, the JMPR evaluation reports on tebuconazole as well as the previously issued EFSA reasoned opinions on tebuconazole.

The toxicological profile of tebuconazole was evaluated in the framework of Directive 91/414/EEC. The ADI and the ARfD were established at 0.03 mg/kg bw per day and 0.03 mg/kg bw respectively.

The metabolism of tebuconazole in plants after foliar application was investigated in three crop groups: fruit crops (grapes), pulses/oilseeds (peanuts) and cereals (wheat). In the peer review, parent tebuconazole was proposed as residue definition for risk assessment and enforcement. In addition, it was recommended to perform a risk assessment also for the triazole derivative metabolites (TDMs), a group of metabolites which may be formed in certain crops treated with fungicides belonging to the triazole class. The metabolic behaviour of tebuconazole depicted in the three crop categories is representative for the intended spray application on leafy crops; for the intended use as a post-harvest treatment on citrus fruits no specific metabolism studies are available. However, as it is unlikely that a differentmetabolic pattern occurs in fruits which were subject to a post-harvest treatment, the residue definition derived for spray applications is considered appropriate also for the post-harvest treatment of citrus.

The supervised residue trials are sufficient and adequate to derive MRL proposals for the crops under consideration. The studies demonstrated that a MRL of 5 mg/kg would be appropriate for citrus fruits (except oranges), 0.5 mg/kg for lettuce and other salad plants including Brassicaceae and 2 mg/kg for parsley and chives. Adequate analytical methods are available to control tebuconazole residues in the crops under consideration at or above the LOQ of 0.02 mg/kg.

Tebuconazole was demonstrated to be stable under conditions simulating pasteurisation, baking/ brewing/boiling and sterilisation. Thus, for processed commodities, parent tebuconazole is proposed as residue definition for risk assessment and enforcement. Based on residue trials a peeling factor of 0.18 was derived for citrus fruit.

Regarding the possible occurrence of tebuconazole residues in rotational and/or succeeding crops EFSA concluded that no tebuconazole residues exceeding the LOQ of 0.02 mg/kg are expected in the edible parts of the rotational crops provided that tebuconazole is applied according to the intended GAPs for lettuce and fresh herbs.

Since by products of citrus (citrus pomace) may be used as a feed for livestock, the potential carry over of residues to food products of animal origin was assessed. EFSA concluded that the contribution of the residues on citrus pomace to the overall dietary intake of food producing animals is insignificant. Thus, the modification of the MRLs for certain citrus crops does not trigger an amendment of the MRLs for food of animal origin proposed by EFSA in the previous reasoned opinion (MRL review under Article 12 of Regulation (EC) No 396/2005).    

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo) taking into account the residue concentrations expected for the intended uses assessed in the framework of this assessment and the recommendations of EFSA derived in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005. Under the assumption that the MRLs will be amended as proposed in the Article 12 review, the  total calculated exposure ranged from 2.7% to 17.2% of the ADI (WHO cluster diet B). Regarding the crops under consideration, mandarins and grapefruit were found to contribute to the overall dietary exposure max. 0.6% of the ADI, respectively; the exposure for the other crops under consideration did not exceed 0.1% of the ADI.

No acute consumer risk was identified in relation to the MRL proposals for citrus fruit, lettuce and other salad plants including Brassicaceae, parsley and chives. The calculated maximum exposure in percentage of the ARfD was 95.1% for grapefruit (DE child), 72.9% for scarole, 59.4% for mandarins, 36.7% for lemons, 22.4% for lettuce, 21.5% for lime, 2.6% for rucola, 3.9% for parsley and 2.3% for lamb’s lettuce. For chives and cress the exposure was less than 1% of the ARfD.

As recommended previously, 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 intended use of tebuconazole on grapefruits, lemons, limes, other citrus fruits (except oranges), lettuce and other salad plants including Brassicaceae (i.e. lettuce, lamb’s lettuce, scarole, cress, land cress, rucola, red mustard, leaves and sprouts of Brassica spp.) as well as on parsley and chives will not result in a consumer exposure posing a consumer health risk.

Thus EFSA proposes to amend the current MRLs as proposed in the summary table.

Keywords
Tebuconazole, citrus fruit, lettuce, chives, parsley, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, triazole fungicide, triazole derivative metabolites
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Number of Pages
37