Normativa UEMay. 4, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para fipronil
Fipronil was included in Annex I to Directive 91/414/EEC on 01 October 2007, which is before the entry into force of Regulation (EC) No 396/2005 on 02 September 2008. EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(1) of the afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked France, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 09 March 2009 and, after having considered several comments made by EFSA, the RMS provided on 01 December 2009 a revised PROFile.
Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, and the additional information provided by the RMS, EFSA issued on 09 November 2011 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 20 January 2012 were considered for finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of fipronil was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.0002 mg/kg bw/d and an ARfD of 0.009 mg/kg bw/d.
Metabolism of fipronil was investigated on five different crops using either soil applications or seed treatment. These crops are representative for cereals (wheat, maize), pulses and oilseed (sunflower, cotton), roots and tubers (sugar beet). Due to the structure of the molecule, metabolism studies were performed with 14C-fipronil labelled on the phenyl ring only. The studies indicate that a common metabolic pathway could be defined for the three crop groups tested. The residue definition for enforcement and risk assessment in all plant commodities is the sum of the parent compound fipronil and its sulfone metabolite, to be expressed as fipronil. The analytical method (DFG S19) has been validated for enforcement of the residue definition in food of plant origin, with a combined LOQ of 0.005 mg/kg in high oil, dry, and high water commodities and also in food of animal origin with a combined LOQ of 0.005 mg/kg in milk, meat, fat, liver, kidney and eggs.
Regarding the magnitude of residues in crops, a sufficient number of supervised residues trials are available for all the crops for which GAPs are supported in the framework of this review. These data allowed EFSA to estimate the expected residue concentrations in these plant commodities and to derive appropriate MRLs.
The effect of processing on the nature of fipronil and the fipronil sulfone metabolite was investigated in the framework of the peer review. Studies were conducted simulating representative hydrolytic conditions for pasteurisation (20 minutes at 90°C, pH 4), boiling/brewing/baking (60 minutes at 100°C, pH 5) and sterilisation (20 minutes at 120°C, pH 6). From these studies, it was concluded that processing by pasteurization, baking/brewing/boiling and sterilization is not expected to have a highly significant impact on the composition of residues in matrices of plant origin. Further processing studies are not required as they are not expected to affect the outcome of the risk assessment. However, if more robust processing factors were to be required by risk managers, in particular for enforcement purposes, additional processing studies would be needed.
Occurrence of fipronil residues in rotational crops was investigated during the peer review. A study showed the metabolism in primary and rotational primary crops is comparable and significant residues in rotational crops are not expected. These studies are considered sufficient by EFSA to demonstrate the absence of residues in rotational crops, provided that fipronil is applied in compliance with the GAPs supported in the framework of this review.
The nature of fipronil residues in commodities of animal origin was also investigated. Reported metabolism studies include one study in lactating goats and one study in laying hens using 14C-phenyl labelled fipronil. These studies demonstrate that fipronil and its sulfone metabolite are the major components of the various investigated matrices, both accounting for more than 70% of the TRR. Therefore the residue definition proposed for both enforcement and risk assessment of animal products is the sum of fipronil and its sulfone metabolite, expressed as fipronil. The magnitude of fipronil residues in both ruminants and poultry was also investigated. Although calculated animal intakes were below the trigger of 0.1 mg/kg, as fipronil residues are fat-soluble and the ADI is low (0.0002 mg/kg bw/day) it was considered that there is a need to consider residues in animal products. Based on the residues in the livestock feeding studies, EFSA was able to derive appropriate MRLs. The available data are considered sufficient for deriving MRLs in ruminants, pigs and hens.
Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo and compared with the toxicological reference value derived for fipronil. The highest chronic exposure was calculated for Dutch children, representing 91.5 % of the ADI, and the highest acute exposure was calculated for milk and milk products, representing 14.0 % of the ARfD.
Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. MRL recommendations were derived in compliance with the decision tree reported in Appendix D (see table below for a summary). All MRL values listed in the table are sufficiently supported by data and therefore proposed for inclusion in Annex II to the Regulation.
A tentative MRL for maize forage is derived in view of the future need to set MRLs in feed items but it needs to be confirmed by 5 additional trials complying with the northern outdoor GAP and 4 additional trials complying with the southern outdoor GAP for maize forage. If this data gap is not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level.