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Reasoned opinion on the review of the existing maximum residue levels (MRLs) for flurtamone according to Article 12 of Regulation (EC) No 396/2005
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 flurtamone. In order to assess the occurrence of flurtamone residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC 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. No information required by the regulatory framework was found to be missing and no risk to consumers was identified.
© European Food Safety Authority, 2012
Flurtamone was included in Annex I to Directive 91/414/EEC on 01 January 2004, 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 afore mentioned 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 23 June 2009 and, after having considered several comments made by EFSA, the RMS provided on 23 April 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 20 June 2012 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 24 August 2012 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of flurtamone was already evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI being established at 0.03 mg/kg bw per d. An ARfD was not deemed necessary.
The metabolism of flurtamone was investigated for pre-emergence and early post-emergence applications in barley and wheat and for pre-emergence applications in sunflower and peanut. In all studies, flurtamone was demonstrated to be extensively degraded through several hydrolytic and oxidative steps to finally form trifluoromethyl benzoate with incorporation into natural plant sugars or triglycerides. As residues of this metabolite are not expected above 0.01 mg/kg the relevant residue for enforcement and risk assessment in cereals, pulses and oilseeds is defined as the parent compound only. Validated analytical methods are available for enforcement of this residue definition in food of plant origin with a LOQ of 0.01 mg/kg in dry and high oil content commodities.
Regarding the magnitude of residues in primary crops, a sufficient number of supervised residue trials are available for the GAPs reported by the RMS, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive tentative MRLs.
As quantifiable residues of flurtamone are not expected in the treated crops, 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.
Following Annex I inclusion, a rotational crop metabolism study, which was carried out on radish, lettuce and wheat, was evaluated by the RMS and demonstrated that degradation of residues in primary crops and rotational crops will proceed through a similar pattern and residues exceeding 0.01 mg/kg are also not expected.
Since the calculated dietary burdens for all groups of livestock were found to be below the trigger value of 0.1 mg/kg DM, further investigation of residues as well as the setting of MRLs in commodities of animal origin is not necessary.
Chronic consumer exposure resulting from the authorisations reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. Considering these crops, the highest chronic exposure represented 0.3 % 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 summary table). All MRL values listed in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation.
It is highlighted 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 gap which is not expected to impact on the validity of the MRLs derived but which might have an impact on national authorisations:
- 8 residues trials analysing for flurtamone residues in straw and supporting the southern outdoor GAP on cereals.
flurtamone, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, pyridazinone, herbicide.