Modification of the existing MRLs for propamocarb in various crops

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(11):4266
doi
10.2903/j.efsa.2015.4266
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2014-00932
EFSA-Q-2015-00421
Approved
9 October 2015
Published
6 November 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 States (EMS), Germany and Belgium, sent an application to change the existing maximum residue levels (MRLs) for the active substance propamocarb in celeriacs, Florence fennel, purslanes and chards, and to maintain the MRL in celery leaves. Germany and Belgium drafted the evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive an MRL proposal at the limit of quantification LOQ of 0.01 mg/kg for Florence fennel, 0.09 mg/kg for the celeriacs, 30 mg/kg for chards, 40 mg/kg for purslanes and to maintain the MRL of 30 mg/kg for celery leaves. Adequate analytical enforcement methods are available to control the residues of propamocarb on the commodities under consideration at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concludes that the proposed use of propamocarb on celeriacs, celery leaves, Florence fennel, purslanes and chards 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 Landwirtschaftskammer Nordrhein-Westfalen to change the existing maximum residue levels (MRLs) for the active substance propamocarb in celeriacs, celery leaves and Florence fennel. In addition the EMS Belgium, compiled an application to modify the existing MRLs for propamocarb in purslanes and chards. The EMS (Germany and Belgium) drafted two evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 19 December 2014 and 7 June 2015 respectively.

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 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 and 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 following foliar applications on fruit, root and leafy crop groups and following soil application on fruit and leafy crop groups. From these studies the peer review concluded to establish the residue definitions for enforcement and for risk assessment as the sum of propamocarb and its salts expressed as propamocarb. For the use on the crops under consideration, EFSA concludes that the metabolism of propamocarb in primary crops is sufficiently addressed and the residue definitions are applicable.

EFSA concludes that the submitted supervised residue trials are sufficient to derive an MRL proposal of 0.01 mg/kg for Florence fennels, 0.09 mg/kg on celeriacs, 30 mg/kg on chards, 40 mg/kg on purslanes and to maintain the current MRL value of 30 mg/kg on celery leaves. Adequate analytical enforcement methods are available to monitor the residues of propamocarb in the commodities under consideration at the validated LOQ of 0.01 mg/kg.

Studies investigating the nature of propamocarb hydrochloride residues under standard hydrolysis conditions were assessed in the framework of the previous Article 10 application and showed the active substance to be hydrolytically stable under standard processing conditions. Consequently, the same residue definition as for raw commodities (RAC) is applicable. Several processing factors were derived for tomatoes, spinaches and head cabbages during the Article 12 MRL review. Additional studies were not submitted and are not requested.

Since the DT90 value of propamocarb is lower than 100 days, data on residues in succeeding crops were not provided and are not requested.

Residues of propamocarb in commodities of animal origin were not assessed, 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). No long-term or acute consumer intake risks were identified. For propamocarb the highest estimated chronic intake accounted for 5% of the ADI (FR toddler) and the highest acute exposure was calculated to be 38% for chards and purslanes.

EFSA concludes that the proposed use of propamocarb on celeriacs, celery leaves, Florence fennel, purslanes and chards will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a health risk to consumers.

Keywords
propamocarb, various crops, MRL application, consumer risk assessment, propamocarb hydrochloride