Normativa UEJul. 25, 2014
UE: modifican límites máximos de residuo de tepraloxydim en alcachofas
In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing MRLs for the active substance tepraloxydim in Jerusalem artichoke and radishes. In order to accommodate for the intended uses of tepraloxydim, Belgium proposed to raise the existing MRLs from the limit of quantification of 0.1 mg/kg to 0.4 mg/kg. Belgium 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 27 February 2014.
EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the Commission Review Report on tepraloxydim, as well as the conclusions from the EFSA Reasoned Opinion on the review of the existing MRLs according Article 12 of Regulation (EC) No 396/2005.
The toxicological profile of tepraloxydim was assessed in the framework of the peer review and the data were sufficient to derive an ADI 0.025 mg/kg bw per day and an ARfD of 0.4 mg/kg bw.
The metabolism of tepraloxydim in primary crops was investigated on root/tuber vegetables and on pulses/oilseeds. Based on these studies the peer review established the residue definition for enforcement and risk assessment as the sum of tepraloxydim and its metabolites that can be hydrolysed either to the 3-(tetrahydro-pyran-4-yl)-glutaric acid moiety or to the 3-hydroxy-(tetrahydro-pyran-4-yl)-glutaric acid moiety, expressed as tepraloxydim. For the use on crops under consideration, EFSA concludes that the metabolism of tepraloxydim in primary crops is sufficiently addressed and the residue definitions are applicable.
EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals of 0.4 mg/kg for the proposed uses on Jerusalem artichoke and radishes. Study to confirm the stability of tepraloxydim residues under frozen conditions in high water content matrices is however requested. Adequate analytical enforcement methods are available to control the residues of tepraloxydim on the commodities under consideration at the validated LOQ of 0.1 mg/kg.
Studies investigating the nature of tepraloxydim residues in processed commodities were assessed in the peer review and showed that tepraloxydim is degraded during pasteurisation, cooking, brewing and sterilisation. During the degradation of tepraloxydim no new metabolites are expected, therefore the residue definitions for enforcement and risk assessment as for raw commodities are applicable.
The occurrence of tepraloxydim residues in rotational crops was investigated during the peer review. Based on the available information, it was concluded that significant residues are unlikely to occur in rotational crops, provided that the active substance is applied according to the GAP (Good Agricultural Practice) proposed on Jerusalem artichoke and radishes.
Residues of tepraloxydim in commodities of animal origin were not assessed in the framework of this application, since the crops under consideration are normally not fed to livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). In the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 a comprehensive dietary exposure assessment was performed, taking into account the existing uses of tepraloxydim. The long-term consumer exposure assessment was now updated including the median residue concentration for Jerusalem artichoke and radishes. The total calculated intake accounted for up to 12 % of the ADI (UK toddler). The contribution of residues in Jerusalem artichoke and radishes to the total consumer exposure accounted for lower than 0.1 % of the ADI.
No acute consumer risk was identified in relation to the MRL proposals for crops under consideration. The calculated maximum exposure was 1 % of the ARfD for radishes (UK toddler).
EFSA concludes that the proposed uses of tepraloxydim on Jerusalem artichoke and radishes will not result in a consumer exposure exceeding the toxicological reference values and therefore, is unlikely to pose a consumer health risk.