Modification of the existing maximum residue levels for propaquizafop in various crops

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(2):4402 [31 pp.].
doi
10.2903/j.efsa.2016.4402
Type
Reasoned Opinion
Question Number
EFSA-Q-2013-00980
EFSA-Q-2015-00702
Approved
3 February 2016
Published
19 February 2016
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) Austria, received an application from the company Makhteshim Agan Industries Ltd to modify the existing maximum residue levels (MRL) for the active substance propaquizafop in cauliflowers and various root and oilseed crops. In addition, the EMS Italy received an application from the company ADAMA Quena N.V. to modify the existing MRLs in head cabbages and the group ‘lettuces and salad plants’. Considering that propaquizafop is an ester variant of quizalofop and since two different MRL datasets are proposed for propaquizafop and quizalofop (including quizalofop-P) under Regulation (EC) No 396/2005, EFSA suggests the two following options: 1) to set specific MRL values for propaquizafop for the crops under consideration; 2) to delete the MRLs for propaquizafop from the EU legislation and to report all MRLs for all quizalofop ester variants in the EU legislation as ‘quizalofop’, considering that the current residue definition reported as ‘quizalofop incl. quizalofop-P’ would have to be amended to ‘quizalofop and quizalofop esters, including propaquizafop expressed as quizalofop (sum of isomers)’. Sufficient data were submitted to propose specific MRLs for propaquizafop for the crops under consideration, except for the group ‘lettuces and salad plants’ since a sufficient number of trials on open leaf varieties of lettuce has not been provided to support an extrapolation. The deletion of the MRLs for propaquizafop as proposed under option 2 would only request to increase the MRL for mustard seeds from the limit of quantification (LOQ) of 0.05 to 0.06 mg/kg. Based on the risk assessment results, EFSA concludes that the proposed uses of propaquizafop 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) Austria, received an application from Makhteshim Agan Industries Ltd to modify some existing MRLs for the active substance propaquizafop. In addition, the EMS Italy received an application from the company ADAMA Quena N.V. to modify the existing MRLs in head cabbages and the group ‘lettuces and salad plants’. Austria proposed to set MRLs at 0.1 mg/kg in celeriacs, parsnips, parsley roots, radishes, poppy seeds, soya beans and mustard seeds and at 0.5 mg/kg in cauliflowers. Italy proposed to increase the MRL from 0.2 to 0.3 mg/kg in head cabbages and from 0.1 to 0.2 mg/kg in lettuces and salad plants. Austria and Italy drafted evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005 which were submitted to the European Commission and forwarded to EFSA on 4 December 2013 and 9 November 2015 respectively.

EFSA bases its assessment on the evaluation reports submitted by the EMS Austria and Italy. Since propaquizafop is an ester variant of the active substance quizalofop-P, the Draft Assessment Reports (DAR) prepared under Directive 91/414/EEC, the Commission Review Reports, the conclusions on the peer review of the pesticide risk assessment and reasoned opinions issued for both active substances propaquizafop and quizalofop-P were considered in this evaluation.

The toxicological profile of propaquizafop was assessed in the framework of the peer review under Directive 91/414/EEC (hereafter peer review) and the data were sufficient to derive an acceptable daily intake (ADI) of 0.015 mg/kg body weight (bw) per day. No acute reference dose (ARfD) was deemed necessary. Separate toxicological reference values were set for the other quizalofop ester variants. Expressed as quizalofop equivalent, the lowest ADI was proposed at 0.0083 mg/kg bw per day and the lowest ARfD at 0.08 mg/kg bw.

The metabolism of propaquizafop in primary crops was investigated in the oilseeds/pulses (cotton, soybean), leafy (lettuce) and root (sugar beet) crop groups. The residue definitions for enforcement and risk assessment were proposed as ‘sum propaquizafop and quizalofop, expressed as quizalofop (sum of isomers)’ in the conclusion of the peer review. Considering that once applied, all ester variants (including propaquizafop) are hydrolysed to quizalofop, EFSA proposed an overall residue definition covering all esters as ‘sum quizalofop esters, quizalofop, expressed as quizalofop (sum of isomers)’. Several analytical methods were proposed to monitor propaquizafop residues in plants. Most of them refer to methods where propaquizafop residues are analysed and quantified as quizalofop (propaquizafop acid) and not as propaquizafop. Additional validation data were submitted in the framework of these MRL applications. Provisionally, EFSA proposes to conclude that sufficient enforcement methods are available, considering that all analytical methods for all ester variants will be reconsidered during the review of the existing MRLs under Article 12 of Regulation (EC) No 396/2005 (hereafter Article 12 MRL review) that will be initiated by 2016 for all quizalofop ester variants. The current residue definition set in Regulation (EC) No 396/2005 is limited to propaquizafop only. EFSA proposes the following options for the setting of MRLs:

Option 1: MRLs are proposed as propaquizafop.

Option 2: Since the residue in plants following the application of the active substance propaquizafop is quizalofop (as for the other ester variants), it is proposed to withdraw the MRLs set for propaquizafop in Regulation (EC) 396/2005 and to report the MRLs for all quizalofop ester variants under ‘quizalofop’, considering that the current residue definition ‘quizalofop incl. quizalofop-P’ would have to be amended to ‘sum quizalofop and quizalofop esters, including propaquizafop expressed as quizalofop (sum of isomers)’.

Under option 1 and when expressed as propaquizafop equivalent, EFSA concludes that a sufficient number of residue trials were submitted to derive MRL proposals of 0.15 mg/kg on celeriacs, parsley roots and radishes, of 0.3 mg/kg on cauliflowers and head cabbages and of 0.08 mg/kg on poppy and mustard seeds and soya beans. In contrast, a sufficient number of trials conducted on open leaf varieties of lettuce has not been provided to propose an MRL for ‘lettuces and salad plants’.

Under option 2, no changes in the MRL values currently listed for quizalofop under Regulation (EC) 396/2005 are requested, except for mustard seeds, whose MRL would need to be increased from limit of quantification (LOQ) of 0.05 mg/kg to 0.06 mg/kg.

Processing studies on cauliflower and head cabbages were submitted. However, since standard hydrolysis studies on the nature of the residues of propaquizafop are not available, EFSA does not recommend the listing of the derived processing factors in Annex IV of Regulation (EC) 396/2005.

Based on the available information, EFSA concludes that significant residue levels are unlikely to occur in rotational crops, provided that the active substance is used according to the proposed uses.

The residues levels observed in the crops under consideration do not request an amendment of the MRLs for animal commodities listed as propaquizafop or as quizalofop in the current EU Regulations.

The consumer risk assessment was performed with the revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). Two different assessments were conducted taking into account the two options proposed for the setting of MRLs for propaquizafop.

Option 1: The chronic consumer risk assessment was conducted taking into account the median residue levels (STMR) derived for the crops under consideration in this reasoned opinion and the MRLs set for propaquizafop in the EU legislation for the other plant and animal commodities. Based on the ADI of 0.015 mg/kg bw per day, no chronic concern was identified, the highest calculated intake being 30% of the ADI (UK, Toddler). An acute risk assessment was not conducted as the setting of an ARfD was concluded to be not necessary for propaquizafop. This assessment should however be considered as a large underestimation, since not considering the additional contribution to the consumer exposure resulting from the uses of the other quizalofop ester variants.

Option 2: The consumer risk assessment was conducted considering all MRLs set for quizalofop under the current EU Regulation (except mustard seeds where the supervised trials median residue (STMR) and highest residue (HR) values were used as input values) and the lowest ADI and lowest ARfD derived during the peer review for the different quizalofop ester variants. Based on this worst case scenario and considering all possible uses of the different quizalofop esters variants, no intake concerns were identified for the consumers, the highest chronic intake accounting for 90% of the ADI (WHO, cluster B) and the highest acute intake for the crops under consideration in the MRL applications for 33% of the ARfD for cauliflower (NL child).

EFSA concludes that the intended uses of propaquizafop on celeriacs, parsnips, parsley roots, radishes, cauliflowers, head cabbages, poppy seeds, mustard seeds and soya beans will not result in a consumer exposure exceeding the lowest toxicological reference values set for the different quizalofop ester variants and therefore are unlikely to pose a consumer health risk.

Keywords
propaquizafop, quizalofop, various crops, MRL application, consumer risk assessment
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Number of Pages
31