Normativa UEMay. 8, 2014
UE: modifican límite máximo de residuo de triflumuron en duraznos, ciruelas, naranjas y mandarinas
In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, hereafter referred to as the evaluating Member State (EMS), received an application from Bayer CropScience AG to modify the existing MRLs for the active substance triflumuron in stone fruits and citrus. Italy proposed to lower the existing MRLs from 1 mg/kg to 0.3 mg/kg in peaches and plums. The data were considered as not sufficient to raise the existing MRLs from 1 mg/kg to 2 mg/kg in oranges and mandarins to accommodate for their import from South Africa. Italy 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 4 December 2013.
EFSA bases its assessment on the evaluation report, the Draft Assessment Report (DAR), its addendum and the Additional Report (AR) prepared under Council Directive 91/414/EEC, the Commission review report on triflumuron and the conclusion on the peer review of the pesticide risk assessment of the active substance triflumuron.
The toxicological profile of triflumuron was assessed in the framework of the peer review under Council Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.014 mg/kg bw per day. No ARfD was deemed necessary for triflumuron. An ARfD of 0.005 mg/kg bw was derived for the metabolite M07 which was observed in metabolism studies in soya bean and potato and which is expected to be formed during food processing (sterilisation).
The metabolism of triflumuron in primary crops was investigated after foliar applications on three different crop groups: fruit and fruiting vegetables (apples, tomatoes), root/tuber vegetables (potatoes) and pulses/oilseeds (soya bean) in the framework of the peer review under Council Directive 91/414/EEC. For the uses on the crops under consideration (fruit and fruiting vegetables group), EFSA concludes that the metabolism of triflumuron is sufficiently addressed and the residue definition for enforcement and risk assessment as triflumuron agreed in the peer review is applicable.
EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals of 0.4 mg/kg and 0.08 mg/kg for the proposed use on peaches and plums, respectively. The import tolerance request for oranges and mandarins is not sufficiently supported by data and no amendment of the existing MRL is proposed. An adequate analytical enforcement method is available to control the residues of triflumuron in the commodities under consideration at the validated LOQ of 0.01 mg/kg.
The effect of processing on the nature of triflumuron residues was assessed in the framework of the peer review. Although hydrolysis of triflumuron was observed under sterilization conditions, with formation of degradation products M07 and M08 in relevant amounts, the parent compound still represented a significant part of the radioactivity. Thus, the same enforcement residue definition as for raw agricultural commodities (RAC) was proposed for processed products. EFSA does not recommend the inclusion of the processing factors derived for peach and plum preserve during the peer review in Annex VI of Regulation (EC) No 396/2005 as not sufficiently robust.
Investigations of residues in rotational crops are not required since the proposed use of triflumuron is on permanent crops.
Residues of triflumuron in commodities of animal origin were not assessed in the framework of this application, since stone fruits are normally not fed to livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For the calculation of the chronic exposure EFSA used the median residue values as derived from the residue trials on peaches and plums and the existing MRLs as established in Annex IIIA of Regulation (EC) No 396/2005. 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 28 % of the ADI. The contribution of residues to the total consumer exposure accounted for a maximum of 0.37 % of the ADI for peaches and 0.07 % of the ADI for plums.
For the active substance triflumuron no acute consumer exposure assessment was performed since no ARfD was established. However, to take into account the acute toxicity of M07 in processed peach and plum products after sterilisation, a separate acute risk assessment was performed for M07. The short-term exposure was calculated using the highest residue concentration for triflumuron observed in the RAC, corrected for the percentage of M07 formed in the hydrolysis study. Although the calculations are just indicative, the approach is sufficiently conservative as it is assumed that the large portion consumed consists of sterilised processed products which were produced without peeling. No acute consumer risk was identified in relation to the potential exposure to the metabolite M07 from processed products undergoing a sterilisation process. The calculated maximum exposure in percentage of the ARfD was 81 % for processed peaches and 9 % for processed plums.
It should be noted that the short and long-term exposure assessments are preliminary and affected by uncertainty resulting from the lack of appropriate information on the magnitude of M07 and M08 in crops different than the fruits and fruiting vegetable and in processed products (sterilised). A more realistic risk assessment will be performed in the framework of Article 12 of Regulation (EC) No 396/2005 when full information on authorised uses of triflumuron and additional data will be available to EFSA.
EFSA concludes that the proposed use of triflumuron on peaches and plums will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk .
Thus EFSA proposes to amend the existing MRLs as reported in the summary table