Reasoned opinion on the modification of the existing MRLs for propamocarb in spring onions and Chinese cabbage

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(8):3811 [18 pp.].
doi
10.2903/j.efsa.2014.3811
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2014-00135
Approved
5 August 2014
Published
8 August 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 MRLs for the active substance propamocarb in spring onions and Chinese cabbage. In order to accommodate for the intended uses of propamocarb, Belgium proposed to raise the existing MRLs from the value of 0.1* mg/kg to 30 mg/kg for spring onions and from 10 mg/kg to 20 mg/kg for Chinese cabbage. 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 MRL proposal of 30 mg/kg for the proposed uses on spring onions and of 20 mg/kg for Chinese cabbage. Adequate analytical enforcement methods are available to control the residues of propamocarb in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of propamocarb on spring onions and Chinese cabbage 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, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing MRLs for the active substance propamocarb in spring onions and Chinese cabbage. In order to accommodate for the intended uses of propamocarb, Belgium proposed to raise the existing MRLs from the value of 0.1* mg/kg to 30 mg/kg for spring onions and from 10 mg/kg to 20 mg/kg for Chinese cabbage. 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 27 February 2014.

EFSA bases its assessment on the evaluation report submitted by EMS, the draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the Review Report on propamocarb, the conclusion on the peer review of the pesticide risk assessment of the active substance propamocarb, the JMPR evaluation report as well as the conclusions from the previous EFSA reasoned opinions on the modification of MRLs on certain crops and the review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005.

The toxicological profile of propamocarb was assessed in the framework of the peer review under Directive 91/414/EEC. For propamocarb hydrochloride, the data were sufficient to derive an ADI of 0.29 mg/kg bw per day and an ARfD of 1 mg/kg bw.

The metabolism was investigated on fruit crops, root/tuber crops and leafy crops following foliar applications and on fruit crops and leafy crops following soil application. From these studies the peer review concluded to establish the residue definition for enforcement and for risk assessment as the sum of propamocarb and its salts expressed as propamocarb. For the use on spring onions and Chinese cabbage, EFSA concludes that the metabolism of propamocarb in primary crops is sufficiently addressed and that the residue definitions are applicable.

EFSA concludes that the residue trials conducted on leeks and kale are sufficient to support the MRL proposals of 30 mg/kg for spring onions and of 20 mg/kg for Chinese cabbage for the intended uses on these crops. Adequate analytical enforcement methods are available to control the residues of propamocarb in the commodities under consideration at the validated LOQ of 0.01 mg/kg.

Studies investigating the nature of propamocarb residues in processed commodities are not available and were not submitted in the framework of MRL review. EFSA is of the opinion that standard hydrolysis study investigating the effect of processing on the nature of the residues would be desirable.

As the DT90 value of propamocarb is lower than 100 days, the occurrence of residues in succeeding crops is unlikely, provided that the compound is used according to the proposed GAP (Good Agricultural Practice).

Residues of propamocarb 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 (PRIMo). In the framework of the review of the existing MRLs for propamocarb 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 propamocarb at the EU level and CXLs set for some commodities at Codex level. EFSA now updates this risk assessment with median residue values on spring onions and Chinese cabbage derived from the supervised residue trials and the proposals for rocket and rucola from the previous application under art 10 of the Regulation (EU) 396/2005.

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 4 % of the ADI (FR toddler).The contribution of residues in Chinese cabbage to the total consumer exposure accounted for a maximum of 0.3 % of the ADI (SE general population) and for spring onions the contribution was lower than 0.1 % of the ADI.

No acute consumer risk was identified in relation to the MRL proposals for crops under consideration. The calculated maximum exposure in percentage of the ARfD was 55 % for Chinese cabbage and 8 % for spring onions.

EFSA concludes that the proposed uses of propamocarb on spring onions and Chinese cabbage will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

Thus EFSA proposes to amend the existing MRLs as reported in the summary table.

Keywords
Propamocarb, spring onions and Chinese cabbage, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, carbamate fungicides, propamocarb hydrochloride
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