A Report about Flutriafol
Flutriafol is one of the 84 substances of the third stage part B of the review programme . In accordance with the Regulation, at the request of the Commission of the European Communities, the EFSA organised a peer review of the initial evaluation,, provided by the United Kingdom, being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicant’s decision.
One of the important applications of Flutriafol(CAS NO: 76674-21-0) is Fertiliser Application. Treated fertiliser should be sown in the same furrow as the seed, not broadcast. Note that the flow rate of fertiliser may be changed after treatment, and the seeder should be calibrated with the treated material to ensure that the correct rates of fertiliser and fungicide are delivered. Do not mix seed with treated fertiliser.
Data gaps were identified in the section identity, physical and chemical properties of the active substance and analytical methods. Data gaps were also identified in the mammalian toxicology section to address the relevance of the impurities present in the technical specification, to set reference values for the plant metabolites triazole alanine and triazole acetic acid, and to characterise the isomer ratio found in residues to which workers are exposed.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of flutriafol as a fungicide on wheat, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.
Flutriafol(CAS NO: 76674-21-0) is very stable in soil and the aquatic environment. It is expected to exhibit medium to high mobility in soil. A critical area of concern has been identified for potential groundwater contamination.
Two data gaps were identified in the ecotoxicology section. Further information should be provided to address the long-term risk to insectivorous birds. The ecotoxicological relevance of the impurities should be addressed. A high long-term risk to insectivorous birds was identified, based on the available data.
Based on the metabolism studies conducted on cereals, oilseed/pulse crops and root crops, the residue for monitoring was limited to the parent flutriafol only. Two separate definitions were proposed for risk assessment; 1) flutriafol and 2) Triazole derivative metabolites (TDM), since TDM were seen to be present in significant proportions and levels in primary and rotational crops. A default MRL value of 0.05 mg/kg was proposed for the crops usually rotated with wheat as there is clear evidence that residues above 0.01 mg/kg are expected in rotational crops.
No residue definition could be proposed for animal products and a new metabolism study on ruminant was identified as a data gap. A data gap was also identified concerning the TDM, since no information was provided to include these metabolites in the consumer risk assessment.
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