Modification of the existing maximum residue levels for acetamiprid in leafy brassicas

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(9):4229 [20 pp.].
doi
10.2903/j.efsa.2015.4229
Type
Reasoned Opinion
Question Number
EFSA-Q-2015-00356
Approved
4 September 2015
Published
1 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 Nisso Chemical Europe to modify the existing maximum residue levels (MRL) for the active substance acetamiprid in leafy brassica (Chinese cabbages, kales). In order to accommodate for the intended uses of acetamiprid, Germany proposed to raise the existing MRLs from the limit of quantification of 0.01 mg/kg to 1.5 mg/kg. 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. The intended use on leafy brassica is adequately supported by residue data but no MRL is recommended by EFSA since an acute consumer intake concern cannot be excluded when considering the acute reference dose for acetamiprid proposed by the EFSA PPR panel in a previous assessment.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Germany, received an application from Nisso Chemical Europe to modify the existing maximum residue level (MRL) for the active substance acetamiprid in leafy brassicas. In order to accommodate for the intended use of acetamiprid, Germany proposed to raise the existing MRL from the limit of quantification (LOQ) to 1.5 mg/kg. 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 3 June 2015.

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 acetamiprid, the JMPR Evaluation report, the Scientific Opinion of the EFSA PPR Panel as well as the conclusions from previous EFSA opinions on acetamiprid.

The toxicological profile of acetamiprid 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 0.07 mg/kg bw per day and an acute reference dose (ARfD) of 0.1 mg/kg bw. However, in 2013, based on additional information on the developmental neurotoxicity potential, the EFSA PPR Panel recommended to lower the ADI and ARfD to a value of 0.025 mg/kg bw per day.

The metabolism of acetamiprid in primary crops was investigated in the fruit, root, leafy and pulses/oilseeds crop groups following foliar applications. From these studies the residue definition for enforcement and for risk assessment was proposed as acetamiprid. These residue definitions were confirmed during the MRL review. EFSA concluded that the metabolism of acetamiprid in primary crops has been sufficiently addressed and that the residue definitions derived are applicable.

The submitted supervised residue trials would be sufficient to derive an MRL proposal of 1.5 mg/kg on leafy brassica, however since an acute risk for the consumers cannot be excluded, EFSA does not recommend changing of the MRL for the crops under consideration.

Studies investigating the nature of acetamiprid residues under standard hydrolysis conditions were assessed during peer review and showed the active substance to be hydrolytically stable. Therefore, the same residue definitions as for raw commodities are applicable to process commodities.

The occurrence of acetamiprid residues in rotational crops was investigated in the framework of the peer review. During Article 12 MRL review and due to insufficient information on the persistent soil metabolite IM-1-5, EFSA recommended for Member States granting an authorisation for acetamiprid, to take the necessary risk mitigation measures in order to avoid residues in rotational crops.

Since EFSA does not recommend the change of the MRL for kales, crop used as feed product, a potential carry-over into food of animal origin was not assessed in the framework of this MRL application.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). In the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 a comprehensive dietary exposure assessment was performed, taking into account the existing uses for acetamiprid. EFSA updates the long-term consumer exposure assessment taking into account the median residue level (STMR) derived for leafy brassicas, and including the STMRs calculated for bananas pulp, the median residue values for the commodities assessed in the two previous EFSA reasoned opinions under art 10 of the Regulation (EU) 396/2005 and the STMR values corresponding to the CXLs that have been taken over in the EU legislation in 2012.

The consumer risk assessment calculations were performed considering the current and the new recommended toxicological reference values, respectively. No long term consumer intake concerns were identified, the highest chronic intake accounting for 18 % of the ADI (DE child) while an acute consumer intake concern was identified using the more conservative toxicological reference value of 0.025 mg/kg bw, accounting 197 % of the ARfD for kales and 108 % for Chinese cabbages.

Consequently, EFSA does not recommend changing the MRL for leafy brassicas (Chinese cabbage and kales) since an acute intake concern cannot be excluded for consumers.

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Number of Pages
20