In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Austria, compiled an application to modify the existing maximum residue level (MRL) for the active substance fluazifop-P in pumpkin seeds. To accommodate for the intended use of fluazifop-P, Austria proposed to set the MRL to the value of 5 mg/kg. Austria 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 the European Food Safety Authority (EFSA) on 5 February 2016.
EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) and its additional reports prepared under Council Directive 91/414/EEC, the revised Commission review report, the conclusions on the peer review of the pesticide risk assessment (RA) of the active substance fluazifop-P as well as previous EFSA reasoned opinions of which one opinion on the review of existing MRLs according to Article 12 (hereafter, Article 12 MRL review).
The toxicological profile of fluazifop-P was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.01 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.017 mg/kg bw.
The metabolism in primary crops has been studied in fruit, leafy, root and oilseeds/pulses crop groups following foliar applications and the residue definition (RD) for enforcement and RA were established as ‘sum of all constituent isomers of fluazifop, its esters and its conjugates expressed as fluazifop (sum of isomers)’. For the use on pumpkin seed, EFSA concludes that the metabolism of fluazifop-P has been sufficiently addressed and that the RDs derived are applicable.
EFSA concludes that the submitted supervised residue trials are sufficient to derive an MRL proposal of 5 mg/kg on pumpkin seeds. Adequate analytical enforcement methods are available to monitor fluazifop-P residues on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01–0.05 mg/kg.
Processing studies were not submitted and are not required with regard to the low contribution of pumpkin seeds to the consumer intake. However, during the peer review several processing factors were derived for rapeseed that can be extrapolated to pumpkin seed.
The occurrence of fluazifop-P residues in rotational crops was investigated in the framework of the peer review and of the Article 12 MRL review. Based on the available information, it was concluded that the RD set for primary crops is applicable to rotational crops and that significant residue levels are unlikely to occur in succeeding crops, provided that the compound is used according to the proposed good agricultural practice (GAP). Residues of fluazifop-P in commodities of animal origin were not assessed as pumpkin seeds are not fed to livestock.
The consumer RA was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). No long-term or acute consumer intake concerns were identified. For fluazifop-P, the highest estimated chronic intake accounted for 42% of the ADI (World Health Organization (WHO) Cluster E). The contribution of residues in the crops under consideration to the total consumer exposure is insignificant (lower than 0.1% of the ADI) and the maximum acute exposure was calculated to be 12% of the ARfD.
EFSA concludes that the proposed use of fluazifop-P on pumpkin seeds will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a health risk to consumers.
