In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, herewith referred to as the evaluating Member State (EMS-UK), received an application from Bayer CropScience to set import tolerances for the active substance fluopicolide on carrots, radishes and sugar beet reflecting the authorised uses in the United States of America. The United Kingdom proposed to set the MRLs at the level of 0.2 mg/kg for radishes and carrots and 0.1 mg/kg for sugar beet and drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 6 January 2012.
In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, hereafter referred to as the evaluating Member State (EMS-IT), received an application from Bayer CropScience to modify the existing MRLs for the active substance fluopicolide on certain leaf vegetables and herbs. In order to accommodate the intended uses of fluopicolide, Italy proposed to raise the existing MRLs from 8 mg/kg on lettuce and the limit of quantification (LOQ) of 0.01 mg/kg on the other salad plants and on fresh herbs to 10 mg/kg (except scarole). For spinach and similar (leaves), the EMS-IT proposed to raise the exiting MRL from the LOQ of 0.01 mg/kg to 3 mg/kg. Italy 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 21 March 2012.
For reasons of efficiency EFSA combined both applications in one reasoned opinion. EFSA bases its assessment on the evaluation reports, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EC, the Commission Review Report on fluopicolide, the conclusion on the peer review of the pesticide risk assessment of the active substance fluopicolide, the JMPR evaluation report as well as the conclusions from previous EFSA opinions on fluopicolide.
The toxicological profile of fluopicolide was investigated in the peer review under Council Directive 91/414/EC and data were sufficient to conclude on an ADI of 0.08 mg/kg bw per day and an ARfD of 0.18 mg/kg bw. For the metabolite 2,6-dichlorobenzamide (M-01) separate toxicological reference values were set (ADI: 0.05 mg/kg bw per day; ARfD: 0.3 mg/kg bw).
The metabolism of fluopicolide in primary crops was investigated in three plant groups: leafy crops (lettuce), fruit crops (grapes) and root/tuber crops (potatoes). From these studies the peer review concluded to establish the residue definition for enforcement as the parent compound fluopicolide. For risk assessment two separate residue definitions were proposed: parent fluopicolide and the M-01 (2,6-dichlorobenzamide). For the use on the crops under consideration, EFSA concludes that the metabolism of fluopicolide in primary crops is sufficiently addressed and that the derived residue definitions are applicable.
EFSA concludes that the submitted supervised residue trials are sufficient to derive the following MRL proposals: 0.2 mg/kg for radishes and carrots; 0.15 mg/kg for sugar beet; 9 mg/kg for the crop group of lettuce and other salad plants, including Brassicaceae and for the crop group of herbs; 4 mg/kg for the crop group of spinach and similar (leaves). In accordance with the guidance document applicable at the time when the MRL application was submitted to the EMS-IT, the MRL proposals for the lettuce and herb groups were derived by extrapolation from residue trials on lettuce (open leaf and head forming varieties). Since in the meantime more strict rules are applicable for the extrapolation (a full data set on only open leaf varieties is needed), EFSA recommends conducting additional trials on open-leaf lettuce to complete the dataset as required in the current guidance document. Adequate analytical enforcement methods are available to control the residues of fluopicolide in the crops under consideration at or above the validated LOQ of 0.01 mg/kg.
Fluopicolide showed to be stable under hydrolytic processing conditions representing boiling, pasteurisation and sterilisation. Thus, for processed commodities the same residue definition as for raw agricultural commodities is applicable. For the crops under consideration no processing studies have been submitted and, according to the European requirements, are not necessary.
Based on the available information on the nature and magnitude of residues in succeeding crops assessed during the peer review, EFSA concludes that significant residue levels of fluopicolide and its metabolite are unlikely to occur in rotational crops provided that the compound is used in lettuce and other salad plants, fresh herbs and spinach and similar (leaves) according to the intended GAPs.
Since sugar beet, if imported from the USA, may be used as feed item, the potential carry-over of residues into food of animal origin was assessed. EFSA concludes that a modification of the existing MRLs for the commodities of animal origin is not required in the framework of the import tolerance application.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). Separate consumer exposure assessments were performed for fluopicolide and the metabolite M-01. The calculated exposures were compared with the toxicological reference values as derived for fluopicolide and M-01.
The short-term risk assessment resulted in a potential consumer health risk associated with the exposure to residues of fluopicolide in scarole. For the most critical indoor use and outdoor use in SEU the exposure accounted for 238 % and 165 % of the ARfD, respectively. A third exposure calculation was therefore performed considering the less critical outdoor use in NEU for scarole; in this scenario the maximum exposure for scarole did not lead to a consumer intake concern (39.8 % of the ARfD). With regard to the other crops under consideration no short-term consumer intake concerns were identified. No acute consumer risk was identified in relation to the exposure to the metabolite M-01 from the intake of the crops for which a MRL is proposed.
No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. Regarding fluopicolide, the total calculated intake values accounted for less than 3 % of the ADI (WHO Cluster diet B). Among the crops under consideration, the major contribution of residues to the total consumer exposure was identified for sugar beet which accounted for a maximum of 1.1 % of the ADI. Regarding the metabolite M-01, the total calculated intake values accounted for up to 0.6 % of the ADI (UK toddler diet). The contribution of residues in the crops under consideration to the total consumer exposure accounted for a maximum of 0.5 % of the ADI in sugar beet roots.
EFSA concludes that the intended uses of fluopicolide on the crops under consideration, except the more critical indoor use and outdoor use in Southern Europe on scarole, will not result in a consumer exposure exceeding the toxicological reference values of fluopicolide and the metabolite M-01 and therefore is unlikely to pose a public health risk. For scarole, EFSA proposes a MRL derived from a less critical use, which is not leading to a consumer concern.
Thus EFSA proposes to amend the existing MRLs as reported in the summary table.