Normativa UEFeb. 6, 2014
UE: autoridad alimentaria modifica límites máximos de residuos para tau-fluvalinate
In accordance with Article 6 of Regulation (EC) No 396/2005, Denmark, hereafter referred to as the evaluating Member State (EMS), received an application from Makhteshim-Agan Holding BV to modify the existing MRLs for the active substance tau-fluvalinate in pome fruits, peaches, apricots, grapes, tomatoes, aubergines, melons, broccoli, Brussels sprouts, kohlrabi, globe artichokes, lettuce and other salad plants. In order to accommodate the intended SEU and NEU uses of tau-fluvalinate, the EMS proposed to raise the existing MRLs in all crops under consideration, except in tomato. EMS 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. According to EFSA the data are sufficient to derive MRL proposals for all crops under consideration. Based on the risk assessment results, EFSA concludes that the intended use of tau-fluvalinate on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. EFSA notes that data gaps regarding toxicity of metabolite 3-phenoxybenzaldehyde and its magnitude in processed commodities were identified and shall be further addressed.
© European Food Safety Authority, 2014
In accordance with Article 6 of Regulation (EC) No 396/2005, Denmark, hereafter referred to as the evaluating Member State (EMS), received an application from Makhteshim-Agan Holding BV to modify the existing MRLs for the active substance tau-fluvalinate in pome fruits, peaches, apricots, grapes, tomatoes, aubergines, melons, broccoli, Brussels sprouts, kohlrabi, globe artichokes, lettuce and other salad plants. In order to accommodate the intended SEU and NEU uses of tau-fluvalinate, the EMS proposed to raise the existing MRLs in all crops under consideration, except in tomato. EMS 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 1 July 2013.
EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR), Additional report and addendum to Additional report prepared under Council Directive 91/414/EEC, and the conclusion on the peer review of the pesticide risk assessment of the active substance tau-fluvalinate.
The toxicological profile of tau-fluvalinate was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.005 mg/kg bw per day and an ARfD of 0.05 mg/kg bw.
The metabolism of tau-fluvalinate in primary crops was investigated in fruits and fruiting vegetables, cereals, pulses and oilseed. From these studies the peer review established the residue definition for risk assessment in all edible crops, except cereal grain, as “tau-fluvalinate”; in cereal grain the residue was defined as “tau-fluvalinate plus anilino acid, including conjugates, calculated as tau-fluvalinate”. The residue definition for enforcement purposes was proposed as “fluvalinate”, considering that the enforcement methods cannot differentiate between fluvalinate and tau-fluvalinate. EFSA concludes that the metabolism of tau-fluvalinate is sufficiently addressed in the crops under consideration and the residue definitions agreed in the peer review are applicable. The current enforcement residue definition in Regulation (EC) No 396/2005 is set as “tau-fluvalinate”. However, as only tau-fluvalinate is approved in the EU, the setting of an enforcement residue definition containing additional isomers is of low relevance for MRL enforcement.
EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals for all crops under consideration. It is noted that the analytical method used in the trials analysed all isomers of fluvalinate. Adequate analytical enforcement methods are available to control the residues of tau-fluvalinate in the commodities under consideration.
Studies investigating the nature of tau-fluvalinate residues in processed commodities were assessed in the peer review, demonstrating almost complete degradation of the active substance to 3-phenoxybenzaldehyde (3-PBAld) and diacid under sterilisation process and to anilino acid under boiling/cooking conditions. Under pasteurisation conditions tau-fluvalinate was relatively stable. Anilino acid and diacid have been observed in the metabolism of rats, goats and plants and anilino acid is included in the risk assessment residue definition for livestock and cereal grain. Metabolite 3-PBAld has been observed in the metabolism of goats and plants; its toxicity has not been investigated. The peer review did not propose the residue definition for processed commodities since the need for processing studies was not triggered. The fruit crops under consideration can be subject to sterilisation process. Since 3-PBAld is a major degradation product under sterilisation conditions and is also a common degradation product of other synthetic pyrethroids (deltamethrin, cypermethrin) under sterilisation conditions, EFSA is of the opinion that 3-PBAld shall be considered for the risk assessment of processed commodities.
The processing studies with peaches were available from the peer review; results demonstrated a reduction of tau-fluvalinate residues in all processed commodities. In peach jam (sterilised commodity) the presence of diacid, anilino acid and 3-PBAld was not confirmed. The applicant submitted two processing studies with grapes where white grapes were processed into young wine and red grapes into raisins, juice, must and wine. A concentration of tau-fluvalinate residues was observed only in grape pomace and raisins.
Since only one processing study on one crop is available investigating the effect of sterilisation on the magnitude of tau-fluvalinate residues, EFSA is of the opinion that additional processing studies involving sterilisation process have to be submitted; various crop matrices shall be tested. In case significant residue concentrations of 3-PBAld are observed, the toxicological relevance of 3-PBAld has to be further investigated. Since toxicity studies with 3-PBAld are not available, on temporary basis it is assumed that toxicity of 3-PBAld is covered by the toxicity of parent compound. The risk assessment residue definition in processed commodities is thus provisionally defined as “tau-fluvalinate”. The derived processing factors are not proposed for the inclusion in Annex VI of Regulation (EC) No 396/2005, taking into account the uncertainties regarding the storage stability, the open questions related to 3-PBAld and insufficient number of processing studies for wine.
Most of the crops under consideration are grown in a crop rotation. The metabolism of tau-fluvalinate in rotational and primary crops was considered to proceed in a similar pathway. Based on the available metabolism study, the peer review concluded that for the representative use rates considered in the peer review, significant residues in rotational crops are not expected. In all intended uses on the crops under consideration, except lettuce, the application rate is the same or lower than the use rate investigated in the peer review. The total seasonal application rate of tau-fluvalinate on lettuce and other salad plants is slightly higher (1.3 N), but, considering the crop interception, EFSA is of the opinion that the use of tau-fluvalinate on lettuce will not result in significant residues in succeeding/rotational crops, provided that the active substance is applied according to the intended GAP. If a crop failure occurs, the authorizing Member State has to ensure that significant residues of tau-fluvalinate do not occur in succeeding crops.
Pome fruit pomace can be fed to livestock and therefore the nature and magnitude of tau-fluvalinate residues in livestock has to be further assessed. The calculated dietary burdens exceed the trigger value of 0.1 mg/kg dry matter (DM) for all relevant livestock species and are mainly driven by the intake of alfalfa and barley grain. The new intended use on pome fruit and subsequent residues in apple pomace will not have a significant impact on the current livestock dietary burden and therefore the possible carry-over of tau-fluvalinate residues in commodities of animal origin was not further investigated in the framework of this application.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For the calculation of chronic exposure, EFSA used the median residue values as derived from the residue trials on the crops under consideration. For several commodities risk assessment values were available as reported by the RMS Denmark in the framework of the setting of temporary MRLs. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annexes IIIA of Regulation (EC) No 396/2005 were used as input values.
The acute exposure assessment was performed only for commodities under consideration. The estimated exposure was then compared with the toxicological reference values derived for tau-fluvalinate.
No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for up to 71% of the ADI (NL diet). The contribution of residues in the crops under consideration to the total consumer exposure (in the percentage of the ADI) accounted for a maximum of 14.5% for apples (DE child diet), 12.8% for wine grapes (FR all population diet), 4.1% for table grapes (DE child diet), 1.5% for tomatoes (WHO Cluster diet B) and was below 1% of the ADI for other crops under consideration.
No acute consumer risk was identified in relation to the intended uses on the crops under consideration. The calculated maximum exposure in percentage of the ARfD was 87% for scarole, 76% for table grapes, 31% for apples and lower for other crops under consideration. EFSA notes a narrow safety margin for scarole and table grapes containing residues at the proposed MRL of 0.7 mg/kg and 1 mg/kg, respectively.
EFSA concludes that using the internationally agreed methodologies for consumer risk assessment the intended use of tau-fluvalinate on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.
EFSA proposes to amend the existing MRLs as reported in the summary table.