Reasoned opinion on the modification of the existing MRL for pyraclostrobin in chicory roots

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(5):3685 [23 pp.].
doi
10.2903/j.efsa.2014.3685
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2013-00820
Approved
30 April 2014
Published
8 May 2014
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, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing MRL for the active substance pyraclostrobin in chicory roots. In order to accommodate for the intended use of pyraclostrobin, Belgium proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.02* mg/kg to 0.09 mg/kg. Belgium 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 0.08 mg/kg for the intended use on chicory roots. Adequate analytical enforcement methods are available to control the residues of pyraclostrobin on the commodity under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of pyraclostrobin on chicory roots 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, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing MRL for the active substance pyraclostrobin in chicory roots. In order to accommodate for the intended use of pyraclostrobin, Belgium proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.02* mg/kg to 0.09 mg/kg. Belgium 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 10 October 2013.

EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) and its addendum prepared under Council Directive 91/414/EEC, the Commission Review Report on pyraclostrobin, the JMPR Evaluation report, as well as the conclusions from previous EFSA opinions on pyraclostrobin.
The toxicological profile of pyraclostrobin was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.03 mg/kg bw per day and an ARfD of 0.03 mg/kg bw.

The metabolism of pyraclostrobin in primary crops was investigated in three different crop groups. The review of the existing MRLs for pyraclostrobin performed under Article 12 of Regulation (EC) No 396/2005 confirmed the conclusion of the peer review that the relevant residue definition for enforcement and risk assessment in all plant commodities treated by foliar application is pyraclostrobin. For the uses on the crop under consideration, EFSA concludes that the metabolism of pyraclostrobin is sufficiently addressed, thus the derived residue definitions are applicable.

EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.08 mg/kg for the intended use on chicory roots. Adequate analytical enforcement methods are available to control the residues of pyraclostrobin on the commodity under consideration at the validated LOQ of 0.02 mg/kg.

Studies investigating the nature of pyraclostrobin residues in processed commodities were assessed in the framework of peer review and showed that the compound is hydrolytically stable under processing conditions representative of pasteurisation, boiling/cooking and sterilisation. Therefore for processed commodities the same residue definition as for raw agricultural commodities (RAC) is applicable.

The occurrence of pyraclostrobin residues in rotational crops was investigated in radish, lettuce and wheat. These studies showed that the metabolism in rotational crops is similar to the metabolism observed in primary crops and that significant residues in rotational crops are not expected. Based on the available information on the nature and magnitude of residues in succeeding crops, EFSA concludes that significant residue levels are unlikely to occur in rotational crops provided that the compound is used on the crops under consideration according to the proposed GAP (Good Agricultural Practice).

Residues of pyraclostrobin in commodities of animal origin were not assessed in the framework of this application, since the chicory roots are normally not fed to livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). In the framework of the review of the existing MRLs for pyraclostrobin according to Article 12 of Regulation (EC) No 396/2005, a comprehensive long term exposure assessment was performed taking into account the existing uses of pyraclostrobin at the EU level. EFSA updates this risk assessment with median residue values on chicory roots derived from the submitted supervised residue trials.
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 up to 14 % of the ADI (DE child). The contribution of residues in chicory roots to the total consumer exposure is insignificant (lower than 0.1 % of the ADI). The calculated maximum exposure in percentage of ARfD was 0.7 % (Belgian adult).

EFSA concludes that the proposed use of pyraclostrobin on chicory roots will not result in a consumer exposure exceeding the toxicological reference value 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
pyraclostrobin, chicory roots, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, strobilurin fungicide and plant growth regulator, desmethoxy metabolite 500M07
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Number of Pages
23