Modification of the existing maximum residue levels for mepanipyrim in blackberries, raspberries and peppers

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(9):4218 [19 pp.].
doi
10.2903/j.efsa.2015.4218
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2015-00359
Approved
19 August 2015
Published
4 September 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, the evaluating Member State (EMS), Spain, received an application from Sipcam Inagra S.A. to modify the existing maximum residue levels (MRLs) for the active substance mepanipyrim in blackberries, raspberries, peppers and cucumbers. In order to accommodate for the intended uses of mepanipyrim, Spain proposed to raise the existing MRLs to 4 mg/kg on raspberries and blackberries, 1 mg/kg on peppers and 0.5 mg/kg on cucumbers. EFSA assessed only the request for cane fruits and peppers since an MRL proposal of 0.5 mg/kg has already been made for cucumbers in a previous Reasoned Opinion considering the same good agricultural practices (GAP). According to EFSA the data are sufficient to derive MRL proposals of 4 mg/kg on raspberries and blackberries and 1.5 mg/kg on peppers. Adequate analytical enforcement methods are available to control the residues of mepanipyrim on the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of mepanipyrim on blackberries, raspberries and peppers will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Spain, received an application from Sipcam Inagra S.A. to modify the existing maximum residue levels (MRLs) for the active substance mepanipyrim in blackberries, raspberries, peppers and cucumbers. In order to accommodate for the intended uses of mepanipyrim, Spain proposed to raise the existing MRLs from the limit of quantification (LOQ) to 4 mg/kg on raspberries and blackberries, 1 mg/kg on peppers and 0.5 mg/kg on cucumbers. Spain 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 the European Food Safety Authority (EFSA) on 3 June 2015. The MRL request for cucumbers has not been considered in the framework of this MRL application, since an MRL proposal of 0.5 mg/kg has already been made for cucumbers by EFSA in a previous Reasoned Opinion, considering the same good agricultural practices (GAP)

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

The toxicological profile of mepanipyrim was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.02 mg/kg bw per day and an acute reference dose (ARfD) of 0.3 mg/kg bw.

The metabolism of mepanipyrim in primary crops was investigated in the fruit crop group following foliar applications. The review of the existing MRLs performed under Article 12 of Regulation (EC) No 396/2005 concluded on the residue definitions for enforcement and risk assessment as mepanipyrim, which are applicable to the use on the crops under consideration.

According to EFSA the data are sufficient to derive MRL proposals of 4 mg/kg on blackberries and raspberries and 1.5 mg/kg on peppers. Adequate analytical enforcement methods are available to control the residues of mepanipyrim on the commodities under consideration at the validated LOQ of 0.01 mg/kg.

Studies investigating the nature of mepanipyrim assessed in a previous reasoned opinion showed that the active substance is stable under standard hydrolysis conditions. Therefore for processed commodities the same residue definition as for raw agricultural commodities (RAC) is applicable. Processing studies were not provided and are not required.

The occurrence of mepanipyrim residues in rotational crops was investigated in the framework of the peer review and the Article 12 MRL review. Based on the available information, EFSA concludes that significant residue levels are unlikely to occur in rotational crops provided that the active substance is used according to the proposed Good Agricultural Practice (GAP).

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. For the calculation of the chronic exposure, EFSA used the supervised trials median residue (STMR) values derived from the residue trials conducted on raspberries and peppers. The assessment was further refined with the STMR values reported in a previous EFSA reasoned opinion and in the Article 12 MRL review. The acute exposure assessment was performed only with regard to the commodities under consideration. The highest chronic exposure was calculated to be 12 % of the ADI (French, all population) and the highest acute exposure 0.7 % of the ARfD for raspberries.

EFSA concludes that the proposed uses of mepanipyrim on blackberries, raspberries and peppers will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a health risk to consumers.

Keywords
mepanipyrim, blackberries, raspberries, peppers, MRL application, consumer risk assessment
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Number of Pages
19