Flutolanil is an existing active substance. The residue profile presented below is based on the Draft Assessment Report (DAR) prepared by the RMS Finland. The final List of
Endpoints presented below is taken from the EFSA Scientific report on flutolanil (2008) 126;
1-63 (d.d. 3 March 2008).
List of Endpoints Residues
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6) Plant groups covered Seed treatment : Potato (R)
Foliar treatment : peanut (P/O) and rice (C).
Rotational crops Oats (C), wheat (C), raddish (R), lettuce (L).
Metabolism in rotational crops similar to metabolism in primary crops?
Yes
Processed commodities Study on the effect of processing not required, considering the low residue level in raw potatoes
Residue pattern in processed commodities similar to residue pattern in raw
commodities?
Yes
Plant residue definition for monitoring Flutolanil.
Plant residue definition for risk assessment
Sum of flutolanil, metabolites M2 and M4 and their conjugates, expressed as flutolanil Conversion factor (monitoring to risk
assessment)
3 (for potatoes)
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
Animals covered Not required
Time needed to reach a plateau
concentration in milk and eggs Not required Animal residue definition for monitoring Not required Animal residue definition for risk
assessment Not required
Conversion factor (monitoring to risk
assessment) Not required
Metabolism in rat and ruminant similar (yes/no)
Not required
Fat soluble residue: (yes/no) Not required
Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
No residues of flutolanil were found in wheat and rape cultivated as rotational crops under field conditions.
Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 Introduction) 18 months for potato, wheat (grain and straw) and rape (grain)
Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3) Ruminant: Poultry: Pig:
Conditions of requirement of feeding studies Expected intakes by livestock ≥ 0.1 mg/kg
diet (dry weight basis) (yes/no - If yes, specify the level)
No No No
Potential for accumulation (yes/no): No No No
Metabolism studies indicate potential level of residues ≥ 0.01 mg/kg in edible tissues (yes/no)
No No No
Feeding studies (Specify the feeding rate in cattle and poultry studies considered as
relevant)
Residue levels in matrices : Mean (max) mg/kg
Muscle Not relevant Not relevant Not
relevant
Liver Not relevant Not relevant Not
relevant
Kidney Not relevant Not relevant Not
relevant
Fat Not relevant Not relevant Not
relevant
Milk Not relevant
Eggs Not relevant
Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4) Crop/ process/ processed product Number of
studies
Processing factors Amount transferred (%)
(Optional) Transfer
factor
Yield factor Potato tuber/distribution in the
edible/non edible portion /peel
1 Not
required as residue level is low
Not relevant
Not calculated
Comments on/additions to List of Endpoints No comments.
5.1 Summary of residue data
The following assessment is based on the DAR and relevant addenda, a summary and evaluation of supervised residue trials by Ctgb (October 2012) and EFSA Scientific report on flutolanil (2008) 126; 1-63 (d.d. 3 March 2008). Flutolanil was discussed by the experts in residues in the PRAPeR meeting 25 (round 5, June 2007). Only the use on potatoes is assessed as the other crops in the intended use are not used for food or feed.
5.1.1 Metabolism in plants
A metabolism study in potatoes was conducted were potatoes underwent a seed treatment.
This metabolism study covers the intended use. Foliar and seed treatments result in similar metabolic pathways.
5.1.2 Metabolism in livestock
Due to low residue levels in treated crops. livestock exposure resulting from the representative use of flutolanil is very low and livestock metabolism studies are not necessary.
A goat metabolism study was nevertheless presented in the Annex II dossier. The study was not accepted by the peer review, but the same study was accepted by the JMPR (FAO, 2002). The Annex II dossier also contained a metabolism study in laying hen, which was considered acceptable.
5.1.3 Residue definition (plant and animal) Plant
The residue definition for monitoring is restricted to the parent compound as it can be
considered as a valid indicator for enforcement purposes. The expert meeting discussed the residue definition for risk assessment and agreed on the inclusion of metabolites M2 and M4 and their conjugates as they are considered, in the absence of any toxicological data, of the same level of toxicity as the parent compound, and expected to be present in consumer diet at levels similar to those of parent compound. A conversion factor from monitoring to risk assessment residue definition is also proposed, i.e. 3 for potatoes only.
Animal
According to the peer review, residue definitions in animal commodities are not proposed and not necessary. However, based on the available animal metabolism studies, the residue definition for enforcement and risk assessment for animal products is flutolanil and all
metabolites containing the 2-trifluromethylbenzoic acid moiety, expressed as flutolanil.
5.1.4 Stability of residues See LoEP.
5.1.5 Supervised residue trials
The DAR contains eight acceptable supervised residue trials in seed potato performed in Northern Europe. Seed potatoes received one treatment with flutolanil as an FS formulation of 87.7-131.5 g/tonne potatoes.
The cGAP-NL is one application of 90 g a.s. /tonne (25% deviation: +/- 22.5 g).
For this application for re-registration, two additional supervised residue trials were submitted where seed potatoes were treated with one application of 96.87 g as/tonne. Trials are
considered acceptable as they were performed in accordance with the current guidelines.
The residue levels selected for MRL setting and risk assessment are presented in table R1.
Table R1: Selected residue levels from trials with flutolanil Crop Residue levels selected for MRL setting
(mg/kg)
STMR (mg/kg)
HR (mg/kg) Potatoes
DAR <0.01 (2x), <0.022, 0.014 (2x), 0.022, 0.03, 0.035
0.014 0.035
Additional trials <0.01 (2x)
5.1.6 Residues in succeeding crops
Confined rotational crop studies indicated that the metabolic pathway in rotational crops is similar to that observed in primary crops although an additional route consisting in oxidation of the isopropyl moiety to alcohol and acid derivatives was observed. Parent compound under free or conjugated form was the major component of the residue. The residue
definitions proposed for primary crops would be evenly valid for rotational crops. A field study has been conducted and no residues were found in wheat and rape cultivated as
rotational crops.
No significant residues are expected in rotational crops. No label restriction related to rotational crops is needed.
5.1.7 Residues from livestock feeding studies
Feeding studies are not required as the trigger of 0.1 mg/kg diet was not exceeded.
5.1.8 Processing factors
Studies are not necessary as the theoretical daily intake (TDI) for potatoes is less than 10%
of the ADI.
5.1.9 Calculation of the ADI and the ARfD Calculation of the ADI
The ADI is based on the NOAEL of 8.7 mg/kg bw/d in the 2-year rat study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ADI of 0.09 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).
Calculation of the ARfD
No ARfD is derived, since flutolanil has no acute toxic properties.
5.2 Maximum Residue Levels
Temporary EU-MRLs are present in Annex IIIa of Regulation (EC) 396/2005. Recently, UK has submitted an MRL application to increase the MRL from 0.5 mg/kg to 0.6 mg/kg. This MRL application does not influence the assessment of Symphonie.
The product complies with the MRL Directives/Regulation.
5.3 Consumer risk assessment
Risk assessment for chronic exposure through diet
A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA PRIMo rev. 2.0, containing all available Member State diets, and the temporary EU-MRLs (including the MRLs at the LOQ for not supported uses) and the conversion factor of 3 for potatoes. The maximum TMDI is 13.9% of the ADI for Dutch children. The TMDI is 6.0% of the ADI for the Dutch general population.
Risk assessment for acute exposure through diet
As no ARfD was derived for flutolanil, a risk assessment for acute exposure was not performed.
Conclusion
Based on the assessment for residues, no risk for the consumer due to the exposure to flutolanil is currently expected. The product complies with the Uniform Principles.
5.4 Data requirements
No data requirements were identified.