Normativa UEMay. 22, 2013
UE: revisan límites máximos de residuo para flumioxazin
Based on the conclusions derived in the framework of Directive 91/414/EEC and the additional information provided by the RMS, EFSA issued on 19 December 2012 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 22 February 2013 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of flumioxazin was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.009 mg/kg bw per d and 0.05 mg/kg bw, respectively.
Primary crop metabolism of flumioxazin was investigated following pre-mergence soil application on fruits and fruiting vegetables and on pulses and oilseeds. Metabolism following foliar application on sugar cane was also investigated and the relevant residue for enforcement and risk assessment in all commodities of plant origin is defined as flumioxazin only. Analytical methods for enforcement of the residue definition are available in foods of plant origin with an LOQ of 0.02 mg/kg in high water content and dry commodities and an LOQ of 0.05 mg/kg in acidic and high fat content commodities.
Regarding the magnitude of residues in all crops reported by the RMS, at least one GAP was supported by a sufficient number of supervised residue trials, which allowed EFSA to estimate the expected residue concentrations in all the relevant plant commodities and to derive appropriate MRLs, except for onions where a tentative MRL is derived.
Significant residues of flumioxazin are not expected in the treated crops that are consumed in a processed form, therefore there is no need to investigate the effect of industrial and/or household processing. In addition, the chronic exposure does not exceed 10 % of the ADI. Specific processing factors for enforcement of processed commodities are therefore not proposed.
As DT90 values of flumioxazin are expected to be lower than 100 days and no relevant soil metabolites were identified, investigation of residues in rotational crops is not required and relevant residues in these crops are not expected.
Based on the uses reported by the RMS, the calculated dietary burden for meat ruminants was the only one to slightly exceed the trigger value of 0.1 mg/kg DM. This calculation is also overestimated because it included several crops where residues are expected to be well below the LOQ. Moreover, metabolism was investigated in goats and laying hens. Considering that the goat metabolism studies were conducted at a dose rate of almost 100N and, in those conditions, TRR in organs and milk never exceeded 0.33 mg eq./kg, EFSA concludes that there is no need to define a residue in commodities of animal origin and that MRLs are not required.
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. The highest chronic exposure represented 5.2 % of the ADI (German children) and the highest acute exposure was calculated for table grapes, representing 6.5 % 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 of the reasoned opinion (see summary table). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL value listed in the table is not recommended for inclusion in Annex II because it requires further consideration by risk managers (see summary table footnotes for details). In particular, a tentative MRL needs to be confirmed by the following data:
eight trials complying with the GAP on onions.
It is highlighted, however, that some of the MRLs derived result from a GAP in one climatic zone only, while other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the validity of the MRLs derived but which might have an impact on national authorisations:
eight trials complying with the southern GAP on sunflower seeds;
eight trials complying with the southern GAP on maize.
If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level.
Minor deficiencies were also identified in the assessment but these deficiencies are not expected to impact either on the validity of the MRLs derived or on the national authorisations. The following data are therefore considered desirable but not essential:
additional residue trials on pome and stone fruit with an LOQ of 0.02 mg/kg;
a detailed evaluation report for the storage stability studies on high water content (soya bean forage, peanut forage, cherries and apples) and high oil content (soya bean and peanut) commodities.