Normativa UEAbr. 4, 2012
UE: autoridad alimentaria modifica límites máximos de residuo para diflufenican en aceitunas para producción de aceite
According to Article 6 of the Regulation (EC) No 396/2005, Spain, herewith referred to as the Evaluating Member State (EMS), received an application from the company SAPEC Agro S.A.U. to modify the existing MRL for diflufenican in olives for oil production. In order to accommodate for the intended use of diflufenican on olives in Spain, the EMS proposes to raise the existing MRL from 0.05* (set at the limit of the quantification (LOQ)) to 0.2 mg/kg. The EMS Spain 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 13 September 2011.
EFSA derives the following conclusions based on the submitted evaluation report prepared by the EMS, the Draft Assessment Report (DAR) prepared by the rapporteur Member State (RMS) United Kingdom under Directive 91/414/EEC as well as the EFSA conclusion on the peer review of the active substance diflufenican.
The toxicological profile of diflufenican was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.2 mg/kg bw/day. Due to the low acute toxicity of the active substance the setting of an ARfD was considered not necessary.
The metabolism of diflufenican in primary crops was investigated in wheat in the framework of the peer review. The peer review concluded that diflufenican is the main residue in cereals for the risk assessment and enforcement. In support of the current MRL application, the applicant submitted and the EMS assessed an additional metabolism study on olives. The study investigated the nature of diflufenican in olives both when harvested from the tree and when picked up from the treated ground/soil. Parent diflufenican is the main residue in olives in both cases. EFSA concludes that the metabolism of diflufenican in olives is sufficiently investigated and the same residue definitions as derived by the peer review are applicable. The existing residue definition in Regulation (EC) No 396/2005 is set as parent diflufenican. An adequate analytical enforcement method is available for the determination of diflufenican residues in plant matrices with high oil content.
The applicant submitted residue trials where the residue situation has been investigated in olives sampled in two different ways. In four studies olives were harvested from the tree (tree harvest) and contained residues below the LOQ of 0.01 mg/kg. In 8 studies olives were shaken off the tree 1 day after the soil treatment and remained on the treated soil until the harvest 33-35 days later (ground harvest). These olive samples contained residues up to 0.13 mg/kg. The EMS claims that the ground harvest represents the worst case situation when, during the harvesting, some olives roll off the blanket/net which is usually placed under olive trees to facilitate the collection of olives fallen off the branches. By this direct contact with the soil a cross-contamination of olives may occur. EFSA concludes that the MRL of 0.01*mg/kg (LOQ) reflecting tree harvest would be sufficient for the use of diflufenican on olives in Spain according to the intended GAP. An alternative MRL proposal of 0.2 mg/kg is derived reflecting ground harvest as the worst case cross-contamination situation.
Specific studies investigating the nature of diflufenican residues in processed commodities have not been performed and are also not required, as the total theoretical maximum daily intake (TMDI) is below the trigger value of 10 % of the ADI. In the framework of the current application, the applicant submitted studies investigating the effects of processing on the magnitude of diflufenican residues in olive oil which was produced from olives collected from the treated soil. Olives were processed into crude oil where a significant concentration of residues was observed (median processing factor of 5). Further study details were not available to explain the disproportional concentration of residues. Given the uncertainties of the study, the derived processing factor is not proposed for the inclusion in Annex VI of Regulation (EC) No 396/2005.
Since the proposed use of diflufenican is on permanent crops, investigations of residues in rotational crops are not required. Olives and/or their by-products are not fed to livestock and therefore the nature of diflufenican residues livestock and potential carry-over of residues into the food of animal origin were not further assessed in the framework of the current application.
The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. For the calculation of the chronic exposure EFSA used the median residue value representing ground harvest as derived from the residue trials on olives for oil production. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annex IIIA of Regulation (EC) No 396/2005 were used as input values. Acute exposure calculations were not undertaken due to the low acute toxicity of the active substance.
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 a maximum of 1.7% of the ADI (maximum for UK infant diet). The contribution of residues in olives for oil production to the total consumer exposure was insignificant (maximum of 0.02 % of the ADI for WHO Cluster diet B).
EFSA concludes that the intended use of diflufenican on olives for oil production will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern.