Reasoned opinion on the modification of the existing MRL for fipronil in poultry fat

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From the livestock feeding studies it becomes evident that the use of fipronil on potatoes requires not only the amendment of the existing MRLs for poultry fat but also for ruminant meat, ruminant fat, ruminant liver, pig meat, pig liver, pig kidney, poultry meat and for milk. The results of the risk assessment show that the dietary exposure of consumers might exceed the toxicological reference value for long-term exposure (ADI). Thus, EFSA concludes that for the use of fipronil on potatoes, which requires the amendment of MRLs for food of animal origin, a potential long-term consumer health risk cannot be excluded, resulting from the residues in animal commodities. Further refinements of the chronic consumer risk assessment or application of risk management options to ensure that the consumer exposure is acceptable are proposed.

In accordance with Article 18(4) of Regulation (EC) No 396/2005 the request from Germany to raise the maximum residue level (MRLs) for fipronil in poultry fat resulting from an emergency authorisation of fipronil on potatoes in accordance with Article 53 of Regulation (EC) No 1107/2009 was submitted to the European Commission who forwarded the request, the evaluation report and the supporting dossier to EFSA on 30 April 2012.

EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) and its addendum prepared under Council Directive 91/414/EEC, the Draft Addendum to the DAR, the Commission Review Report on fipronil, the conclusion on the peer review of the pesticide risk assessment of the active substance fipronil, the JMPR Evaluation as well as the previous EFSA opinion on the MRL review of fipronil.

The toxicological profile of fipronil was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.0002 mg/kg bw per day and an ARfD of 0.009 mg/kg bw.

The metabolism of fipronil in primary crops was investigated in five different crops following soil application or seed treatment. From these studies the peer review concluded to establish the residue definitions for enforcement and risk assessment as sum of fipronil and its sulfone metabolite (MB43136) expressed as fipronil. For the use on potatoes (soil treatment) the metabolism of fipronil is sufficiently addressed and the derived residue definitions are applicable.

EFSA considers that the submitted supervised residue trials are sufficient to derive an MRL proposal of 0.01 mg/kg for the proposed use on potatoes. Adequate analytical enforcement methods are available to control the residues of fipronil and its sulfone metabolite in the commodity under consideration at the validated LOQ of 0.005 mg/kg for each individual component of the residue definition.

Studies investigating the nature of fipronil residues in processed products demonstrate that the compound is hydrolytically stable. Therefore for processed commodities the same residue definitions as for raw agricultural commodities (RAC) are applicable. Several processing studies for potatoes were provided and the data were sufficient to derive the following processing factors, which are recommended to be included in Annex VI of Regulation (EC) No 396/2005:

The occurrence of fipronil 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 in succeeding crops, it is concluded that significant residue levels are unlikely to occur in rotational crops provided that the compound is used according to the authorised GAP for potatoes.

Since potatoes are used as feed product and fipronil is known to accumulate in fat tissue, a potential carry-over of fipronil residues into food of animal origin was assessed, although the calculated livestock dietary burden did not exceed the trigger value of 0.1 mg/kg (dry matter) for the relevant species. The nature of fipronil residues in livestock has been sufficiently investigated to propose the enforcement and risk assessment residue definition as sum of fipronil and its sulfone metabolite (MB46136) expressed as fipronil. The residue is considered fat soluble. The calculated livestock dietary burden was driven by the livestock intake of potatoes and the residues expected on kale and cabbage. From the livestock feeding studies EFSA concluded that the use of fipronil on potatoes requires not only the amendment of the existing MRLs for poultry fat (0.03 mg/kg) but also for ruminant meat (0.15 mg/kg), ruminant fat (0.15 mg/kg), ruminant liver (0.05 mg/kg), pig meat (0.1 mg/kg), pig liver (0.03 mg/kg), pig kidney (0.015 mg/kg), poultry meat (0.03 mg/kg) and for milk (0.015 mg/kg).

The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo) taking into account the use on potatoes and the proposed amendments for animal commodities. For the long-term consumer risk assessment EFSA included the input values derived in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005.

No acute consumer risk was identified in relation to the MRL proposals for the commodities assessed. The calculated maximum exposure in percentage of the ARfD was 16.6 % for milk (UK infant).

The total calculated long-term exposure accounted for up to 149 % of the ADI (FR toddler). The major contributor to the overall dietary exposure is milk which accounted for 119 % and 116 % of the long-term consumer intake for French toddlers and UK infants. The other animal commodities for which MRL modifications were considered necessary contributed to a significantly lower extent to the consumer exposure (maximum bovine meat: 8.5 % of the ADI). The contribution of residues in potatoes to the total consumer exposure accounted for a maximum of 8.8 % of the ADI (NL child).

The consumer risk assessment demonstrated that based on the available data it can not be excluded that the consumer exposure might exceed the toxicological reference value for long-term exposure (ADI). Thus, EFSA concludes that for the use of fipronil on potatoes, which requires the amendment of MRLs for food of animal origin, a potential long-term consumer health risk cannot be excluded.

The consumer risk assessment is calculated by using conservative assumption and therefore is affected by uncertainties. Further refinements of the chronic consumer risk assessment would be possible, in particular with regard to the contribution of milk to the overall dietary intake. A feeding study with lactating ruminants performed with the appropriate dose levels and more sensitive analytical methods (LOQ for fipronil and its sulfone lower than 0.01 mg/kg) would allow a better estimation of the expected median residue concentration in milk. Considering that feeding studies are time intensive and costly, alternative risk management options could be considered, e.g. the withdrawal of authorisations for crops which have a significant influence on the dietary burden for milk ruminants such as the use on cabbage and kale.

EFSA proposes to amend the MRLs as reported in the previous reasoned opinion issued by EFSA on the MRL review under Article 12, without amendment of the MRL for potatoes (0.005 mg/kg).