EFSA Proposes Modification of Existing MRLs for Fenamidone

In order to accommodate for the intended uses of fenamidone, it is proposed to raise the existing MRLs from the limit of quantification value of 0.02 mg/kg with the exception of melons (0.01 mg/kg) to 0.3 mg/kg in cucurbits with edible and inedible peel and to 0.05 mg/kg in strawberries.

12 Apr 2010 --- According to Article 6 of the Regulation (EC) No 396/2005, France, herewith referred as the Evaluating Member State (EMS), received an application from Bayer CropScience Europe to modify the existing MRLs for the active substance fenamidone in cucurbits with edible and inedible peel and in strawberries. In order to accommodate for the intended uses of fenamidone, it is proposed to raise the existing MRLs from the limit of quantification value of 0.02 mg/kg with the exception of melons (0.01 mg/kg) to 0.3 mg/kg in cucurbits with edible and inedible peel and to 0.05 mg/kg in strawberries. France 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 19 November 2009.

EFSA derived the following conclusions based on the evaluation report drawn up by France, the Review Report on fenamidone from the European Commission and the Draft Assessment Report (DAR) drafted by France, the Rapporteur Member State (RMS), under the Directive 91/414/EEC. The toxicological profile of fenamidone was investigated in the peer review and the data were sufficient to conclude on an ADI value of 0.03 mg/kg bw/day. This toxicological value was conservatively applied to the fenamidone main metabolite, RPA 405862, which occurred in crops but was not identified in the rat metabolism. Due to the low acute toxicity, an ARfD was not established. The metabolism of fenamidone in plants was evaluated under the peer review in three crop categories (fruits and fruiting, leafy, root and tuber vegetables) and the metabolic pattern showed to be similar in all these crop groups, but differences were noted regarding the quantities of metabolites occurring. In particular, the metabolite RPA 405862 was formed at significant levels in grapes. Therefore, the proposed residue definition for risk assessment was set as the parent compound for all commodities but grapes, where it was defined as the sum of fenamidone and RPA 405862, expressed as fenamidone.

Fenamidone will undergo a full risk assessment in the framework of Article 12(2) of Regulation (EC) No 396/2005 and the RMS, France, is proposing to include RPA 405862 as residue of concern for risk assessment purposes for all crops. In this regard EFSA recommends that the sum of fenamidone and RPA 405862, expressed as fenamidone, shall be applied for the risk assessment of all commodities, including cucurbits with edible and inedible peel and strawberries. The estimated consumer intakes for the crops under consideration were very low, so it should not be necessary to revisit these conclusions in light of a modification of the proposed residue definition for risk assessment. For enforcement purposes, the residue definition can be limited to the parent compound only.

An adequate number of supervised residue trials on cucumbers, melons and strawberries with appropriate geographic representation were submitted to allow both the proposal for MRL setting and the extrapolation from cucumbers and melons to the respective groups of cucurbits with edible and inedible peel. Since the residues of RPA 408056 were also investigated, conversion factors (CF) could be derived and a refined consumer risk assessment based on the residue definition including the fenamidone metabolite was feasible.

Sufficient storage stability data are available and the supervised trial data were generated with adequate analytical methods, which were capable to detect fenamidone and the RPA 405862 metabolite.

The effect of processing on the nature of fenamidone residues was investigated in the framework of the peer review with hydrolysis studies. Fenamidone was considered stable under hydrolytic processing conditions except under pasteurization, where the metabolite RPA 405862 was formed at significant levels. No specific processing studies were submitted with regard to this application but are considered not necessary in view of the low contribution to the dietary exposure (max cucumbers 0.6% of ADI).

Based on the rapid degradation of fenamidone in soil and the rotational crop study submitted by the applicant, it can be concluded that, if fenamidone is used according to the proposed GAP, no significant residues of the parent compound and its metabolites are expected in rotational crops. Since cucurbits and strawberries are not used as livestock feeding items, the nature and magnitude of fenamidone in livestock was not considered with regard to the current application.

The consumer risk assessment was performed with revision 2 of the EFSA PRIMo, Pesticides Residue Intake Model (EFSA, 2007). To predict the expected long-term consumer exposure, EFSA used the median residue values (STMR) together with the conversion factors (CF) derived from the supervised residue trials on cucumbers, melons and strawberries. In addition, for cucurbits with inedible peel, the STMR value (0.05 mg/kg) was further multiplied by the provisional peeling factor derived from the supervised residue trials in melons and for grapes the MRL value (0.5 mg/kg) was multiplied by the CF resulting from the supervised residue trials evaluated in the framework of the peer review. The existing MRLs as established in Annex II and III of Regulation (EC) No 396/2005 were used for the remaining crops. The estimated long-tem dietary exposures were then compared with the ADI.

No long-term intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated dietary intake ranged from 2 to 15 % of the ADI. Among the crops under consideration, the maximum contribution to the total consumer exposure was for cucumbers and accounted for 0.6 % of the ADI (DK child diet). No acute intake calculations were performed since there is no ARfD value established.

Consequently EFSA concludes that the intended use of fenamidone on cucurbits with edible peel, cucurbits with inedible peel and strawberries will not result in an exceedance of the toxicology reference value and derives the following recommendations: Modification of the existing MRLs for fenamidone in strawberries, cucurbits with edible peel and cucurbits with inedible peel.