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Reasoned opinion on the modification of the existing MRLs for quizalofop-P in oilseed rape, sunflower, cotton and soybean
In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, hereafter referred to as the evaluating Member State (EMS), received from Nissan Chemical Europe an application to modify the existing MRLs of quizalofop-P in rapeseed, sunflower, cotton and soybean. Spain 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. The submitted residue trials lead to MRL proposals of 0.3 mg/kg for rapeseed and 0.4 mg/kg for sunflower. These proposals are already covered by the existing EU MRL of 0.5 mg/kg for rapeseed and by the proposals of 0.7 mg/kg made by EFSA for sunflower in an application related to the ester variant quizalofop-P-tefuryl. EFSA is therefore of the opinion that the uses of quizalofop-P-ethyl on oilseed rape and sunflower do not necessitate any change to the existing EU MRLs or to the proposals done in a previous MRL application. The extrapolations to cotton and soybean are not recommended, since not in line with the rules defined in the current EU guideline. An enforcement method referenced AN34 validated to control quizalofop-P-ethyl residues in oily matrices has been submitted. This method is however an outdated method using techniques no longer in use in laboratories for routine analyses. Considering that a LC-MS/MS method corresponding to the current analytical standards has been developed to analyse the samples from the trials performed from 2007, EFSA is of the opinion that validation data, including an ILV, have to be requested for such an analytical method. Based on the risk assessment results, EFSA concludes that the proposed uses of quizalofop-P-ethyl on oilseed rape and sunflower will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.
© European Food Safety Authority, 2012
In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, hereafter referred to as the evaluating Member State (EMS), received from Nissan Chemical Europe an application to modify the existing MRLs for the active substance quizalofop-P in oilseed rape, sunflower, cotton and soybean. Spain 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 13 September 2011.
EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Reports (DAR) prepared under Council Directive 91/414/EEC for the active substances quizalofop-P-ethyl, quizalofop-P-tefuryl and propaquizafop, the Commission Review Report on quizalofop-P, the conclusion on the peer review of the pesticide risk assessment of the active substance quizalofop-P and propaquizafop, as well as the conclusions from a previous EFSA opinion on quizalofop-P.
The toxicological profile of quizalofop-P-ethyl was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to propose an ADI of 0.009 mg/kg bw per day (0.0083 mg/kg bw per day when expressed as quizalofop-P equivalent). No ARfD was deemed necessary.
The metabolism of quizalofop-P-ethyl in primary crops was investigated in sugar beet (root vegetables), cotton and soybean (pulses/oilseeds group). From these data and from the additional studies conducted with the other ester variants, the peer review concluded to establish a general residue definition for the different quizalofop-P esters as "sum of quizalofop-esters, quizalofop and quizalofop conjugates, expressed as quizalofop (sum of isomers)" both, for enforcement and risk assessment. Therefore EFSA concludes that the metabolism in primary crops was sufficiently addressed to support the use of quizalofop-P-ethyl on oilseeds. The enforcement residue definition established in Regulation (EC) No 396/2005 2005 is set as “quizalofop (including quizalofop-P)”.
The submitted residue trials conducted with quizalofop-P-ethyl according to the intended GAPs lead to MRL proposals of 0.3 mg/kg for oilseed rape and 0.4 mg/kg for sunflower. These MRL proposals refer to the wider residue definition derived in the peer review. However, on a provisional basis these MRLs can be included in the current residue definition, noting that the MRLs are slightly overestimating the expected residues for quizalofop since also the esters and conjugates are covered by the MRLs. EFSA notes that the existing MRL for rape seed is 0.5 mg/kg; thus, the uses of quizalofop-P-ethyl on oilseed rape according to the intended GAPs do not necessitate a change to the existing EU. For sunflower seed the proposed MRL is lower than the MRL proposal of 0.7 mg/kg derived in a previous MRL assessment related to the ester variant quizalofop-P-tefuryl; this MRL proposal has not yet been taken over in EU legislation. The extrapolation of the MRL proposals derived in this assessment to cotton and soybean is not recommended by EFSA, since not in line with the extrapolation rules defined in the current EU guidelines.
A validated analytical enforcement method referenced AN34 to control the residues of quizalofop-P-ethyl in high oil content matrices has been submitted. This method is however an outdated method using techniques no longer in use in laboratories for routine analyses, as more appropriate approaches are nowadays available. Considering that a LC-MS/MS method (AN41) corresponding to the current routine analytical standards has been recently developed by the applicant to analyse the samples from the residues trials performed from 2007, EFSA is of the opinion that full validation data including ILV, have to be requested for such an analytical method.
Studies investigating the nature of quizalofop-P-ethyl residues in processed commodities are not available. Taking into account the overall consumer exposure which exceeds the trigger value of 10% of the ADI, studies investigating the nature of residues in processed food should be provided. One processing study on sunflower was submitted, providing some evidence that the residues in refined sunflower seed oil are significantly reduced. However, EFSA does not recommend the inclusion of the processing factors derived for sunflower meal and sunflower oil in Annex VI of Regulation (EC) No 396/2005, as based on one study only.
The occurrence of quizalofop-P-ethyl residues in rotational crops was investigated in the framework of the peer review. Based on the available information on the nature and magnitude of residues in succeeding crops, it was concluded that significant residue levels are unlikely to occur in rotational crops, provided that the compound is used on oilseeds according to the proposed GAPs.
Residues in commodities of animal origin were not assessed in the framework of this application, since the supported uses of quizalofop-P-ethyl on oilseed crops do not result in changes to the existing or proposed MRL values and the intended uses will not have an impact on the dietary exposure of livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). Since information to perform a complete dietary consumer risk assessment for quizalofop-P was not available to EFSA, the calculation of chronic exposure was conducted using the MRL values currently into force under Regulation (EC) No 396/2005, except for sunflower and cotton where the MRL proposals of 0.7 mg/kg and 0.15 mg/kg made in a EFSA reasoned opinion related to the ester variant quizalofop-P-tefuryl were used as input values. Considering this worst case assessment, no long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo, as the highest calculated intake value accounted for 90 % of the ADI (WHO Cluster B). The contribution of residues in rapeseed and sunflower to the total consumer exposure is limited to a maximum of 6 % of the ADI.
Therefore, EFSA concludes that the proposed uses of quizalofop-P-ethyl on oilseed rape and sunflower will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.
Since the use of quizalofop-P-ethyl on oilseed rape and sunflower according to the intended GAPs results in residue levels already covered by the existing MRLs or by the proposals already made in a former reasoned opinion, EFSA does not recommend to amend the existing MRLs or MRL proposals for quizalofop-P, as summarized in the table below.
Quizalofop-P-ethyl, oilseeds, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, aryloxyphenoxypropionic herbicide.