Modification of the existing maximum residue levels for acequinocyl in cherries and plums

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(10):4259 [19 pp.].
doi
10.2903/j.efsa.2015.4259
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2014-00930
Approved
5 October 2015
Approved
26 October 2015
Published
23 October 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) Germany, received an application from Landwirtschaftliches Technologiezentrum Augustenberg to modify the existing maximum residue levels (MRLs) for the active substance acequinocyl in cherries and plums. In order to accommodate for the intended Northern Europe (NEU) uses of acequinocyl, Germany proposed to raise the existing MRLs from the limit of quantification of 0.01 mg/kg to 0.1 mg/kg for cherries and to 0.02 mg/kg for plums. Germany 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 0.1 mg/kg for cherries and 0.02 mg/kg for plums in support of the proposed use of acequinocyl in Germany. Based on the risk assessment results, EFSA concludes that the proposed use of acequinocyl on cherries and plums 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 evaluating Member State (EMS) Germany, received an application from Landwirtschaftliches Technologiezentrum Augustenberg to modify the existing maximum residue levels (MRLs) for the active substance acequinocyl in cherries and plum. In order to accommodate for the intended uses of acequinocyl, Germany proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.01 mg/kg to the MRL of 0.1 mg/kg for cherries and to 0.02 mg/kg for plums. Germany 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 1 December 2014.

EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) and its addenda prepared under Council Directive 91/414/EEC, the Commission review report on acequinocyl, the conclusion on the peer review of the pesticide risk assessment of the active substance acequinocyl, as well as the conclusions from previous EFSA reasoned opinions on acequinocyl.

The toxicological profile of acequinocyl 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 0.023 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.08 mg/kg bw.

The metabolism of acequinocyl in primary crops was investigated in fruit crop group following foliar application. For the fruit crop group the residue for the enforcement and risk assessment was defined as parent acequinocyl. EFSA concludes that the metabolism of acequinocyl is sufficiently addressed and that the derived residue definitions are applicable.

EFSA concludes that the submitted residue trials are sufficient to derive a MRL proposal of 0.1 mg/kg for cherries and 0.02 mg/kg for plums. Adequate analytical enforcement methods are available to monitor the residues of acequinocyl in high water and high acid content plant matrices at the validated LOQ of 0.01 mg/kg.

Specific studies investigating the nature and magnitude of acequinocyl residues in processed commodities are not available and are not required, as the total theoretical maximum daily intake (TMDI) is below the trigger value of 10 % of the ADI.

As the proposed uses of acequinocyl are on permanent crops and since the crops under consideration are normally not fed to livestock, investigation of residues in rotational crops and livestock is not required.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). The highest calculated chronic intake accounted for 8 % of the ADI (DE child). An acute consumer risk was not identified in relation to the MRL proposals for plums and cherries (highest acute consumer exposure was calculated to be 1 % of the ARfD for cherries and plums).

EFSA concludes that the intended use of acequinocyl on cherries and plums will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a health risk to consumers.

Keywords
acequinocyl, cherries, plums, MRL application, consumer risk assessment
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Number of Pages
19