Reasoned opinion on the modification of the existing MRLs for isopyrazam in various crops

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(1):3994 [25 pp.].
doi
10.2903/j.efsa.2015.3994
Type
Reasoned Opinion
On request from
European Commission
Question Number
No EFSA-Q-2014-00399
Approved
18 December 2014
Published
16 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, France, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta France SAS to modify the existing MRLs for the active substance isopyrazam in tomatoes, aubergines, cucurbits-edible peel and cucurbits-inedible peel. In order to accommodate for the intended uses of isopyrazam, France proposed to raise the existing MRLs from the limit of quantification of 0.01 mg/kg to 0.5 mg/kg for tomatoes and aubergines, from 0.06 mg/kg to 0.4 mg/kg for cucurbits-edible peel and from 0.07 mg/kg to 0.3 mg/kg for cucurbits-inedible peel. 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. According to EFSA the data are sufficient to derive an MRL proposal of 0.5 mg/kg on tomatoes extrapolated to aubergines and MRL proposals of 0.4 mg/kg and 0.3 mg/kg for cucurbits-edible peel and cucurbits-inedible peel respectively, to cover the proposed indoor and NEU and SEU outdoor uses of isopyrazam. Based on the risk assessment results, EFSA concludes that the proposed uses of isopyrazam on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore, is unlikely to pose a consumer health risk.

Summary

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 France SAS to modify the existing MRLs for the active substance isopyrazam in tomatoes, aubergines, cucurbits-edible peel and cucurbits-inedible peel. In order to accommodate for the intended uses of isopyrazam, France proposed to raise the existing MRLs from the limit of quantification of 0.01* mg/kg to 0.5 mg/kg for tomatoes and aubergines, from 0.06 mg/kg to 0.4 mg/kg for cucurbits-edible peel and from 0.07 mg/kg to 0.3 mg/kg for cucurbits-inedible peel. 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 on 21 May 2014.

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

The metabolism in primary crops was investigated in grape (fruit crop), lettuce (leafy crop) and in wheat (cereal). From these studies the peer review established the residue definition for enforcement as isopyrazam (sum of isomers) and as sum of isopyrazam (sum of isomers) and hydroxy-isopyrazam (free and conjugated, sum of isomers), expressed as isopyrazam for risk assessment. For the uses on the crops under consideration, EFSA concludes that the metabolism of isopyrazam is sufficiently addressed and that the residue definitions are applicable.

EFSA concludes that the submitted supervised residue trials are sufficient to derive an MRL proposal of 0.5 mg/kg on tomatoes extrapolated to aubergines and MRL proposals of 0.4 mg/kg and 0.3 mg/kg for cucurbits-edible peel and cucurbits-inedible peel respectively, to cover the proposed indoor and NEU and SEU outdoor uses of isopyrazam. An unusual residue behaviour of isopyrazam in cucumbers and melons has to be highlighted. Based on the same GAPs, significantly higher residues were observed in the northern outdoor trials compared to the indoor and southern outdoor trials. No rationale was provided to explain such a situation. An overall conversion factor for risk assessment (CF) of 1.3 is proposed for the fruiting vegetables crop group. An adequate analytical enforcement method is available to determine the residues of isopyrazam at the validated LOQ of 0.01 mg/kg. An ILV validated in high water content matrices is however required according to the current guidance documents.

Isopyrazam residues are stable under standard hydrolysis conditions representative of pasteurisation, boiling/cooking and sterilisation. Therefore for processed commodities the same residue definitions as for raw agricultural commodities (RAC) are applicable. Several processing studies were provided and the data were sufficient to derive the following processing factors, which are recommended to be included in Annex VI of Regulation (EC) No 396/2005:

  • Melon, peeled:          0.3
  • Tomato, juice:           0.4
  • Tomato, canned:       0.2
  • Tomato, puree:         5
  • Tomato, paste:          7
  • Tomato, ketchup:      3.6
  • Tomato, sun-dried     11

 

In the course of the peer review, EFSA was unable to conclude on the possible residue levels of isopyrazam and its metabolites in the rotational crops. Since additional information was not submitted in the framework of this MRL application, the magnitude of isopyrazam residues in rotational crops could not be addressed.

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

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). No long-term consumer intake concerns were identified for any of the European diets incorporated in the model. The total calculated chronic intake accounted for up to 12 % of the ADI (DE, child). The contribution of residues in the crops under consideration to the total consumer exposure accounted for ca 1 % of the ADI (WHO cluster B). No acute consumer risk was identified in relation to the MRL proposals, the maximum acute exposure was calculated to be 7 % of the ARfD for cucumber (NL, child). EFSA concludes that isopyrazam on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore, is unlikely to pose a consumer health risk.

No significant shift in the syn- and anti-isomer ratio was observed within 7 days after application in the residue trials. However, since isopyrazam consists of two enantiomeric pairs of syn- and anti-isomers respectively, the preferential metabolism/degradation of each enantiomer and its possible impact on the consumer risk assessment was not addressed. The additional contribution to the consumer intakes of isopyrazam residues in rotational crops could indeed not be addressed. Nevertheless, in view of the limited estimated consumer exposure (12 % ADI), EFSA is of the opinion that there is a sufficient large margin of safety to conclude that the missing information on enantiomers and rotational crops has no significant impact on the consumer exposure assessment.

Thus EFSA proposes to amend the existing MRLs as reported in the summary table.

Keywords
isopyrazam, fruiting vegetables, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, hydroxy-isopyrazam, pyrazole-carboxamide fungicide
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Number of Pages
25