Normativa UEMay. 22, 2013
UE: revisan límites máximos de residuo para flupyrsulfuron-methyl
Flupyrsulfuron-methyl was included in Annex I to Directive 91/414/EEC on 01 July 2001, which is before the entry into force of Regulation (EC) No 396/2005 on 02 September 2008. EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(2) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked France, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 14 August 2009 and, after having considered several comments made by EFSA, the RMS provided on 05 November 2012 a revised PROFile.
Based on the conclusions derived in the framework of Directive 91/414/EEC and the additional information provided by the RMS, EFSA issued on 24 January 2013 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 29 March 2013 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of flupyrsulfuron-methyl was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI being established at 0.035 mg/kg bw per d. An ARfD was not deemed necessary.
The metabolism of flupyrsulfuron-methyl was investigated in field and glasshouse grown wheat following foliar spray application of radiolabelled flupyrsulfuron-methyl at the application rate of up to 16.8 g a.s./ha at the 3-4 leaf stage. The elimination of flupyrsulfuron-methyl in wheat was rapid. There were no detectable residues of flupyrsulfuron-methyl or its metabolites (< 0.01 mg/kg) in mature field-wheat grain. The residue definition for risk assessment and enforcement was flupyrsulfuron-methyl. This residue definition is limited to the evaluated foliar use on cereals as the nature of the residues was not investigated in pulses and oilseeds. A validated analytical method for enforcement of the residue definition is not available and therefore is still required. As co-RMS for the renewal of the approval of flupyrsulfuron-methyl under Regulation (EC) No 1107/2009, France informed EFSA that several additional studies (including a metabolism study on linseed and enforcement methods in dry, acidic, high fat and high water content commodities) which would address the data gaps identified in this MRL review have already been evaluated. However as the Renewal Assessment Report (RAR) is not yet finalised, the additional data reported by France have not been considered in the framework of this MRL review, in order to avoid anticipating the conclusions of the renewal process.
Regarding the magnitude of residues in primary crops, a sufficient number of supervised residue trials are available for most of the GAPs reported by the RMS, which allowed EFSA to estimate the expected residue concentration in the relevant plant commodities and to derive MRLs. However, all MRLs are considered tentative due to the data gaps identified regarding analytical methods for enforcement, metabolism in oilseeds and storage stability in high oil content commodities.
As quantifiable residues of flupyrsulfuron-methyl are not expected in the treated crops, there is no need to investigate the effect of industrial or household processing. In addition, the chronic exposure does not exceed 10 % of the ADI.
In the framework of the peer review, field soil dissipation studies indicated that <0.001 mg/kg flupyrsulfuron-methyl or its metabolites remain in the soil 100 days after application. Flupyrsulfuron methyl was applied at a rate of 10 g a.s./ha which is approximately equivalent to a soil level of 0.01 mg/kg in the root zone of most crops (the upper 10-15 cm). Therefore a level of <0.001 mg/kg is less than 10 % of the initial application, and studies on succeeding crops are not required due to low levels of parent in the soil.
The calculated dietary burden for all groups of livestock were found to be below the trigger value of 0.1 mg/kg DM, therefore further investigation of residues as well as setting of MRLs in commodities of animal origin is not necessary.
Chronic consumer exposure resulting from the authorized uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. The highest chronic exposure represented 0.6 % of the ADI (Danish child). Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance.
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 table below for a summary). The MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see table footnotes for details). In particular, some tentative MRLs still need to be confirmed by the following data:
a representative study investigating primary crop metabolism in pulses and oilseeds (including investigation of residues at a forage stage);
a residues storage stability study for high oil content commodities supporting the periods of storage of linseed in the residue trials described in the PROFile;
a validated analytical method for enforcement of residues in oilseeds and cereals (including ILV and confirmatory method);
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. During the MS consultation France informed EFSA that studies addressing these data gaps will be addressed in the framework of the renewal of the approval under Regulation (EC) No 1107/2009.
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:
an evaluation report which provides details of the storage stability study of flupyrsulfuron-methyl in dry commodities.