In order to accommodate for the intended use of fluazinam in SEU (Italy), France proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.05 mg/kg to 0.3 mg/kg. The EMS 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.
The submitted data are sufficient to derive a MRL proposal of 0.3 mg/kg for the proposed use of fluazinam on apples in the SEU (Italy). An adequate analytical enforcement method is available to control fluazinam residues in apples at the LOQ of 0.01 mg/kg.
EFSA concludes that the intended use of fluazinam on apples will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern.
In accordance with Article 6 of Regulation (EC) No 396/2005, France, herewith referred to as the evaluating Member State (EMS), received an application from ISK Biosciences Europe N.V. to modify the existing MRL for the active substance fluazinam in apples. In order to accommodate for the intended use of fluazinam in SEU (Italy), France proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.05 mg/kg to 0.3 mg/kg. The EMS 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 29 February 2012.
EFSA bases its assessment on the evaluation report submitted by the EMS (France, 2011), the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC (Austria, 2005) and the conclusion on the peer review of the pesticide risk assessment of the active substance fluazinam (EFSA, 2008).
The toxicological profile of fluazinam was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.01 mg/kg bw per day and an ARfD of 0.07 mg/kg bw.
The metabolism of fluazinam in primary crops was investigated in tuber vegetables, oilseeds and fruits. Based on the metabolic pattern in potato tubers the peer review proposed to define parent fluazinam as the relevant residue for enforcement. This definition was restricted to potatoes as the representative use for the peer review. In apples the main residue after foliar application is parent fluazinam and therefore EFSA concludes that the enforcement residue definition as proposed by the peer review is also applicable for apples and no additional metabolism studies are required. The current residue definition in Regulation (EC) No 396/2005 is set as fluazinam.
Regarding the risk assessment residue definition, the peer review noted a concern related to the formation of trifluoroacetic acid (TFAA) in primary crops (peanuts) and rotational crops. However, the available studies were not sufficient to conclude on the toxicological properties of the TFAA. The peer review therefore concluded to set a provisional risk assessment residue definition for all plant commodities as “fluazinam, AMPA-fluazinam, AMGT, expressed as fluazinam”. Low concentration of TFAA was observed in apple juice and pomace extract, but in raw apples TFAA was not identified. Considering that the application rate in metabolism studies is significantly higher than the application rate in the intended use under consideration, EFSA concludes that TFAA will be of no concern in apples treated according to the intended use. Therefore for apples the provisional risk assessment residue definition as agreed by the peer review is applicable. EFSA notes that clear provisions have to be agreed between EU Member States, European Commission and EFSA on how to address the toxicity of the TFAA and how to assess the consumer exposure to this compound not only from the use of fluazinam but any other pesticides containing the trifluoromethyl moiety.
EFSA considers that the submitted supervised residue trials data are sufficient to derive a MRL proposal of 0.3 mg/kg for the proposed use of fluazinam on apples in the SEU (Italy). An adequate analytical enforcement method is available to control fluazinam residues in apples at the LOQ of 0.01 mg/kg.
The effect of processing on the nature of fluazinam has not been investigated in a standard hydrolysis study and adequate studies would therefore be desirable. Specific studies to assess the magnitude of fluazinam residues during the processing of apples are not available and are not currently required.
Since the proposed use of fluazinam is on permanent crops, investigations of residues in rotational crops are not required.
Since the apple pomace can be fed to livestock, a potential carry-over of fluazinam residues into food of animal origin has to be assessed. The calculated dietary burdens indicate that the trigger value of 0.1 mg/kg dry matter (DM) is exceeded for meat ruminants and pigs and is mainly driven by the existing use on potatoes. However, taking into account that in the supervised field trials the residues in potatoes were below the LOQ, the peer review concluded that in practice the intake of fluazinam residues by livestock is likely to be insignificant and a carry-over of fluazinam residues to food of animal origin is not expected. As the contribution of residues in apple pomace to the total livestock dietary burden is low, EFSA did not investigate further the nature and magnitude of fluazinam residues in livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used the median residue value multiplied by the conversion factor of 1.68 for risk assessment as derived from the residue trials on apples. The risk assessment values were also available for potatoes and wine grapes to refine the exposure calculation. For the remaining commodities of plant and animal origin, the existing MRLs are set at the LOQ of 0.05 mg/kg and it was assumed that no uses on these crops exist, and fluazinam metabolites, as included in the risk assessment residue definition, are not present. The existing MRLs were thus used as input values without applying a conversion factor. The acute exposure assessment was performed only with regard to apples, assuming the consumption of a large portion of the food item as reported in the national food surveys containing residues at the highest level as observed in supervised field trials. The estimated exposure was then compared with the toxicological reference values derived for fluazinam.
No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 33.3% of the ADI (UK infant diet). The contribution of residues in apples to the total consumer exposure accounted for a maximum of 6.1 % of the ADI.
No acute consumer risk was identified in relation to the intended use on apples. The calculated maximum exposure in percentage of the ARfD was 35.3% for apples.
EFSA concludes that the intended use of fluazinam on apples will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern.
