In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) the Netherlands, received an application from Bayer Environmental S.A. for the active substance fluopicolide in valerian. In order to accommodate for the uses of fluopicolide, the Netherlands proposed to raise the existing MRL from the limit of quantification (LOQ) to the proposed MRL of 5 mg/kg. The Netherlands 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 8 May 2015.
EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) (and its addenda) prepared under Council Directive 91/414/EEC, the Commission review report on fluopicolide, the conclusions on the peer review of the pesticide risk assessment of the active substance fluopicolide, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) Evaluation report as well as the conclusions from previous EFSA opinions on fluopicolide.
The toxicological profile of fluopicolide and its transformation product 2,6-dichlorobenzamide (BAM or M-01) were assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive acceptable daily intakes (ADI) of 0.08 mg/kg bw per day for fluopicolide and 0.05 mg/kg body weight (bw) per day for BAM (M-01). The data were also sufficient to derive Acute reference doses (ARfD) of 0.18 mg/kg bw and 0.3 mg/kg bw for fluopicolide and BAM (M01), respectively.
The metabolism of fluopicolide in primary crops was investigated in the fruit, root and leafy crop groups. The residue definitions were concluded as fluopicolide for enforcement and as fluopicolide and 2,6-dichlorobenzamide (BAM, M-01) reported separately for risk assessment. Adequate analytical enforcement methods are available to monitor the residues of fluopicolide in valerian roots at the validated LOQ of 0.01 mg/kg.
Studies investigating the nature of fluopicolide residues under standard hydrolysis conditions were assessed during the peer review and showed the active substance to be hydrolytically stable. Therefore for processed commodities the same residue definition as for raw commodities (RAC) is applicable.
The occurrence of fluopicolide 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, this reasoned opinion concluded that significant residues are likely to occur in rotated root crops, when fluopicolide is used according to the proposed good agricultural practice (GAP) on potatoes, which the EMS proposed would represent the critical primary crop GAP. It was concluded that the residue definition for assessment in following root crops should be the same as that in primary crops (i.e. fluopicolide for enforcement and fluopicolide and 2,6-dichlorobenzamide (BAM, M-01) reported separately for risk assessment).
Rotational field studies on residues in fresh valerian roots following applications of fluopicolide to potato crops as primary crop were provided. As the MRL for valerian according to the crop definition in Annex I of Regulation (EC) No 396/2005 specifies that residues are for the dried product (root), a dehydration factor of 8 was considered to estimate the residues in dried roots from the levels measured in fresh roots. EFSA concludes that the submitted data are sufficient to derive an MRL proposal of 7 mg/kg in valerian (dried).
Residues of fluopicolide in commodities of animal origin were not assessed, since valerian roots are normally not fed to livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). Regarding fluopicolide, a long-term consumer intake concern was not identified for any of the European diets. The total calculated chronic intake accounted for up to 3 % of the ADI (WHO Cluster B). An acute consumer risk was not identified in relation to the MRL proposal for valerian. The highest acute consumer exposure was calculated to be 2.5 % of the ARfD (UK, vegetarian).
Regarding BAM (M-01), a long-term consumer intake concern was not identified for any of the European diets. The contribution of residues in valerian roots to the total consumer exposure accounted for a maximum of 0.1% of the ADI (Irish, adult). An acute consumer risk was not identified in relation to the MRL proposal for valerian. The highest acute consumer exposure was calculated to be 0.8 % of the ARfD (UK, vegetarian).
EFSA concludes that the use of fluopicolide on potatoes preceding a valerian crop will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a concern for public health.