Normativa UEAbr. 10, 2013
UE: autoridad alimentaria revisa límites máximos de residuo para flusilazole
According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance flusilazole. In order to assess the occurrence of flusilazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.
© European Food Safety Authority, 2013
Flusilazole was included in Annex I to Directive 91/414/EEC on 01 January 2007, 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 Ireland, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 13 May 2010 and, after having considered several comments made by EFSA, the RMS provided on 14 May 2012 a revised PROFile.
Based on the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS, EFSA issued on 12 November 2012 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 11 January 2013 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of flusilazole was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.002 mg/kg bw per d and 0.005 mg/kg bw, respectively.
Primary crop metabolism of flusilazole was investigated in four different crop groups following foliar applications. Based on these studies, EFSA proposes parent flusilazole as a provisional residue definition for enforcement and risk assessment purpose for all plants pending a harmonized approach on how to consider triazole derivative metabolites (TDMs) in the risk assessment. Validated analytical methods for enforcement of this provisional residue definition are available with an LOQ of 0.01 mg/kg in high water content, high fat content, acidic and dry commodities.
Regarding the magnitude of residues in primary crops, the available residue data are considered acceptable to derive MRL proposals as well as risk assessment values for all commodities under evaluation. Tentative MRLs were also derived for sugar beet tops, fodder beet tops, fodder beet roots and cereal straw in view of the future need to set MRLs in feed items.
In processed commodities, parent flusilazole residues were shown to be stable during pasteurisation, cooking, boiling/brewing/baking and sterilisation and no formation of toxicologically relevant metabolites occurs. Studies investigating the magnitude of residues in some processed products were available. Robust processing factors could only be derived for grape juice, white wine and raisins. With regard to the risk assessment of flusilazole, further processing studies are not required as they are not expected to affect the outcome of the risk assessment. However, if there would be the intention to derive more robust processing factors, in particular for enforcement purposes, additional processing studies would be required.
The potential incorporation of soil residues into succeeding and rotational crops was investigated in barley, wheat, cabbage, beet and soya bean during the peer review. This study showed comparable metabolic patterns in primary and succeeding crops and significant residues of parent flusilazole in rotational crops are not expected considering the application rates proposed in the framework of this MRL review. Nevertheless, triazole derivative metabolites might be of concern in rotational crops and this situation will be reconsidered as soon as a global approach on TDMs will be defined.
Based on the uses reported by the RMS, significant intakes were calculated for ruminants and pigs. Metabolism in lactating ruminants and poultry was sufficiently investigated and findings can be extrapolated to pigs as well. The relevant residue definition for enforcement and risk assessment was defined as the sum of flusilazole and its metabolite IN-F7321 ([bis-(4-fluorophenyl)methyl]silanol), expressed as flusilazole. Available feeding studies in livestock also demonstrated that significant residues of flusilazole in edible matrices of ruminants and pigs are expected, and that MRLs for these commodities can be established above the LOQ. The MRLs however should be considered on a tentative basis only as further validation of the analytical method for enforcement is still required. MRLs are not required for poultry products because poultry is not expected to be exposed to significant levels of flusilazole residues.
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. For milk, bovine kidney and liver, an exceedance of the ARfD was identified representing 159 %, 204 % and 117 % of the ARfD, respectively. MRLs and risk assessment values for commodities of animal origin were therefore recalculated assuming that livestock would not be fed with wheat/rye straw (particularly in southern Europe) or sugar beet leaves (both in northern and southern Europe). In this case, the highest chronic exposure represented 40.0 % of the ADI (Dutch children) and the highest acute exposure amounted to 83.9 % of the ARfD (bovine kidney).
Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for flusilazole. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out and exceedances of the ARfD were identified for the existing CXLs in bovine liver, kidney and meat (271, 127 and 187 %), sheep and swine meat (151 and 124 %), apples (255 %), pears (237 %), table grapes (144 %), apple juice (133 %) and peaches (119 %). An additional calculation was carried out excluding these CXLs as well as the CXLs on bovine, sheep and swine fat, because the CXLs on bovine, sheep and swine meat lead to an exceedance of the ARfD and the residue in commodities of animal origin is fat soluble. The highest chronic exposure then represented 44.0 % of the ADI (Dutch children) and the highest acute exposure amounted to 83.9 % of the ARfD (bovine kidney).
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 values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see summary table footnotes for details). In particular, some tentative MRLs, existing MRLs or CXLs still need to be confirmed by the following data:
· an analytical method fully validated (with its ILV) for enforcement of the residue in animal products;
· a study investigating storage stability of flusilazole in kidney.
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.
It is also highlighted that MRLs for commodities of animal origin are based on the assumption that straw in southern Europe and sugar beet leaves in northern and southern Europe would not be fed to livestock because livestock commodities from animals exposed to these feed items may lead to exceedances of the ARfD for the final consumer. Therefore, MS should consider defining restrictions to avoid exposure of livestock to these feed items or, if such restrictions are not considered feasible, withdrawal of the following authorisations at national level:
· Wheat and rye: critical southern GAP with 2 applications at the rate of 0.2 kg a.s./ha and PHI of 28 days;
· Sugar beet: critical northern and southern GAPs with 2 applications at the rate of 0.15 kg a.s./ha and PHI of 42 days and with 3 applications at the rate of 0.10 kg a.s./ha and PHI of 15 days, respectively.
EFSA also emphasises that the above assessment does not yet take into consideration triazole derivative metabolites (TDMs). Since these metabolites may be generated by several pesticides belonging to the group of triazole fungicides, EFSA recommends that a separate risk assessment should be performed for TDMs as soon as the confirmatory data requested for triazole compounds in the framework of Directive 91/414/EEC have been evaluated and a general methodology on the risk assessment of triazole compounds and their triazole derivative metabolites is available.