Reasoned opinion on the modification of the existing maximum residue levels (MRLs) for mepanipyrim in tomato, aubergine, strawberry and cucumber

Tabs

Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(3):4037 [24 pp.].
doi
10.2903/j.efsa.2015.4037
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2014-00396
Approved
26 February 2015
Published
5 March 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (458.83 KB)
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, The Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from K-I Chemical Europe SA/NV to modify the existing maximum residue levels (MRLs) for the active substance mepanipyrim in strawberries, tomatoes, aubergines, and cucumbers. In order to accommodate for the intended uses of mepanipyrim, the EMS proposed to raise the existing MRLs from 1.5 mg/kg to 3 mg/kg in strawberries, from 0.8 mg/kg to 1.5 mg/kg in tomatoes and aubergines and from 0.01 mg/kg to 0.5 mg/kg in cucumbers. The EMS 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 MRL proposals of 3 mg/kg on strawberries, 1.5 mg/kg on tomatoes (extrapolated to aubergines) and 0.5 mg/kg on cucumbers. Adequate analytical enforcement methods are available to control the residues of mepanipyrim in on the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of mepanipyrim on strawberry, tomato, aubergine and cucumber 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, The Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from K-I Chemical Europe SA/NV to modify the existing maximum residue levels (MRLs) for the active substance mepanipyrim in strawberries, tomatoes, aubergines, and cucumbers. In order to accommodate for the intended uses of mepanipyrim, the EMS proposed to raise the existing MRLs from 1.5 mg/kg to 3 mg/kg in strawberries, from 0.8 mg/kg to 1.5 mg/kg in tomatoes and aubergines and from 0.01 mg/kg to 0.5 mg/kg in cucumbers. The EMS 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 27 May 2014.

EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) (and its addendum/addenda) prepared under Council Directive 91/414/EEC, the Commission Review Report on mepanipyrim as well as the conclusions from a previous EFSA opinion on the review of the existing MRL for mepanipyrim under Article 12 of Regulation (EC) No 396/2005.

The toxicological profile of mepanipyrim was assessed in the DAR by the rapporteur Member State Italy and the data were sufficient to derive an ADI of 0.02 mg/kg bw per day and an ARfD of 0.3 mg/kg bw.

The metabolism of mepanipyrim in primary crops was investigated in grape, tomato and apple (fruit crop group). From these studies the peer review concluded to establish the residue definition for enforcement and risk assessment as mepanipyrim. For the use on strawberries, tomatoes, aubergines, and cucumbers, EFSA concludes that the metabolism of mepanipyrim in primary crops is sufficiently addressed and that the residue definitions derived are applicable.

EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals of 3 mg/kg on strawberries, 1.5 mg/kg on tomatoes (extrapolated to aubergines) and 0.5 mg/kg on cucumbers. Adequate analytical enforcement methods are available to control the residues of mepanipyrim in on the commodities under consideration at the validated LOQ of 0.01 mg/kg.

Studies investigating the nature of mepanipyrim residues under standard hydrolysis conditions were submitted in the framework of this MRL application. It was concluded that mepanipyrim is hydrolytically stable under processing conditions representative of pasteurisation, boiling and sterilisation. Therefore for processed commodities the same residue definition as for raw agricultural commodities is applicable. Additional processing studies on strawberry and tomato were provided and therefore, EFSA updated the processing factors (PF) derived for strawberry and tomato in its previous assessments and recommends the inclusion of the following PFs in Annex VI of Regulation (EC) No 396/2005.

  • Strawberry/Jam: 0.47
  • Strawberry/Canned: 0.60
  • Tomato/Juice: 0.15
  • Tomato/Ketchup: 0.70
  • Tomato/Canned: 0.06
  • Tomato/Paste: 0.92
  • Tomato/Puree: 0.62

The occurrence of mepanipyrim residues in rotational crops was investigated in the framework of the peer review and under the Article 12 MRL review. Based on the available information, it was concluded that significant residue levels are unlikely to occur in rotational crops provided that the compound is used on crops under consideration according to the proposed Good Agricultural Practice.

Residues of mepanipyrim 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. In the framework of Article 12 MRL review, a comprehensive long-term consumer exposure assessment was performed, taking into account the existing uses of mepanipyrim at European Union level which are supported by data. EFSA updates the risk assessment performed under the Article 12 MRL review including the median (STMR) and highest (HR) residue levels as derived from the residue trials on strawberry, tomato and cucumber. The highest chronic exposure was calculated to be 12 % of the ADI (FR, all population), and the highest acute exposure 17 % of the ARfD for tomatoes.

EFSA concludes that the proposed use of mepanipyrim on strawberry, tomato, aubergine and cucumber 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 MRL as reported in the summary table.

Keywords
mepanipyrim, fruit crops, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, anilino-pyrimidine
Print on demand
Number of Pages
24