Modification of the existing maximum residue level for kresoxim-methyl in leeks

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(8):4215 [18 pp.].
doi
10.2903/j.efsa.2015.4215
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2015-00284
Approved
18 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), the Netherlands, received an application from BASF SE to modify the existing maximum residue level (MRL) for the active substance kresoxim-methyl in leeks. In order to accommodate for the intended use of kresoxim-methyl, the Netherlands proposed to raise the value of existing MRL to 9 mg/kg. The Netherlands 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 a MRL proposal of 10 mg/kg for the proposed use on leeks. An adequate analytical enforcement method is available to control the residues of kresoxim-methyl on the commodity under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of kresoxim-methyl on leeks will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the Netherlands received an application from BASF SE to modify the existing maximum residue level (MRL) for the active substance kresoxim-methyl in leeks. In order to accommodate for the intended use of kresoxim-methyl, the Netherlands proposed to raise the existing MRL to 9 mg/kg. The Netherlands 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 24 April 2015.

EFSA bases its assessment on the evaluation report, the assessment report and its final addendum prepared for the renewal of the inclusion of kresoxim-methyl in Annex I to Directive 91/414/EEC, the Commission review reports on kresoxim-methyl, the JMPR evaluation report, the conclusion on the peer review of the pesticide risk assessment of the active substance kresoxim-methyl as well as the conclusions from previous EFSA opinions on kresoxim-methyl.

The toxicological profile of kresoxim-methyl 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 0.4 mg/kg bw per day. No acute reference dose (ARfD) was deemed necessary.

The metabolism of kresoxim-methyl in primary crops was investigated in three crop groups following foliar applications. The review of the existing MRLs for kresoxim-methyl performed under Article 12 of Regulation (EC) No 396/2005 confirmed the conclusion of the peer review that the relevant residue definition for enforcement is kresoxim-methyl. For risk assessment, the residue definition is the sum of kresoxim-methyl and the metabolites BF 490-2 and BF 490-9, free and conjugated, expressed as parent compound. For the use on leeks, EFSA concludes that the metabolism of kresoxim-methyl in primary crops has been sufficiently addressed and that the residue definitions derived are applicable.

EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 10 mg/kg on leeks. An adequate analytical enforcement method is available to monitor the residues of kresoxim-methyl on the commodity under consideration at the validated LOQ of 0.05 mg/kg.

Since kresoxim-methyl was almost totally degraded to the acid metabolite BF 490-1 under sterilisation conditions, this metabolite was added to the residue definition for enforcement and risk assessment set in primary crops. Studies investigating the magnitude of kresoxim-methyl residues in processed leek products were not provided and are not required.

The occurrence of kresoxim-methyl residues in rotational crops was investigated in the framework of the peer review and the same residue definition as for primary crops was established for rotational crops. The conclusion of the Article 12 MRL review that sufficient information is not available to confirm that the use of the active substance on leeks as primary crop will not result in the presence of significant residues in rotational crops is still valid. Under the Article 12 MRL review, EFSA identified a data gap for field crop rotational trials which is also relevant for the current application. Meanwhile, Member States should consider this point when granting authorisations and, where relevant, take appropriate risk mitigation measures in order to avoid the presence of kresoxim-methyl residues in rotational crops.

Residues of kresoxim-methyl in commodities of animal origin were not assessed, since leeks are normally not fed to livestock.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). EFSA updated the chronic consumer risk assessment conducted under the Article 12 MRL review taking into account the median residue level (STMR) derived from the residue trials on leeks assessed in this opinion. No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for 1.1 % of the ADI. No acute consumer exposure assessment was performed, since the setting of an ARfD was not necessary for kresoxim-methyl.

EFSA concludes that the proposed use of kresoxim-methyl on leeks will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a health risk to consumers.

Keywords
kresoxim-methyl, leeks, MRL application, consumer risk assessment
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Number of Pages
18