Normativa UEMar. 21, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para florasulam
Florasulam was included in Annex I to Directive 91/414/EEC on 01 October 2002, 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 afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Belgium, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 21 April 2009 and, after having considered several comments made by EFSA, the RMS provided on 20 January 2010 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 26 September 2011 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 02 December 2011 were considered for finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of florasulam was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.05 mg/kg bw/d. No ARfD was deemed necessary.
Metabolism of florasulam was investigated in the cereal crop group following foliar application. Metabolic pathway suggests metabolisation of the parent compound via hydroxylation on the phenyl ring and subsequent glucose conjugation. Other metabolites were considered as non relevant considering the low TRR in wheat ears and the exaggerated rate tested compared to the critical EU GAPs considered for this exercise. Therefore the residue definition for risk assessment and enforcement purposes in cereals and grass can be established as florasulam. Analytical methods for enforcement of the residue definition are reported 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 cereals and feed crops (cereal straws and grass) reported by the RMS, all GAPs were supported by a sufficient number of supervised residue trials, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive appropriate MRLs.
Studies on the effects of processing on the nature and magnitude of florasulam residues are neither available nor required due to very low residues in raw commodities.
The potential incorporation of soil residues into succeeding and rotational crops was investigated in spring wheat, sunflower, cabbage and carrot. Based on the available studies, total residue levels higher than 0.01 mg/kg are not expected in rotational crops, provided that florasulam is applied according to the GAPs supported in the framework of this review.
Based on the uses reported by the RMS, significant intakes were calculated for meat and dairy ruminant. Metabolism in ruminants and poultry was sufficiently investigated and findings can be extrapolated to pigs as well. The relevant residue definition in food of animal origin, for both enforcement and risk assessment can be defined as florasulam. Available metabolism studies also demonstrated that residues of florasulam are not expected in significant amounts since they are very polar and extensively excreted. Consequently, MRLs in ruminants can tentatively be set at the default MRL of 0.01 mg/kg. It is highlighted however that no analytical method for determination of parent florasulam in food of animal origin is available. MRLs are not required for pigs and poultry products because pigs and poultry are not expected to be exposed to significant levels of florasulam residues.
Chronic consumer exposure resulting from the uses supported in the framework of this review was calculated. The highest chronic exposure represented 0.7 % of ADI for the Dutch children. 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 (see table below for a summary). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and 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 table footnotes for details). In particular, certain tentative MRLs still need to be confirmed by the following data:
• an analytical method for enforcement of florasulam in food of animal origin.
Minor deficiencies were also identified in the assessment but these deficiencies are not expected to impact either on the validity of the ‘Recommended’ MRLs or on the national authorisations. The following data are therefore considered desirable but not essential:
• trials for cereal straws and grass complying with GAP carried out with the enforcement LOQ of 0.01 mg/kg.