TRIFLOXYSTROBIN (213) The first draft was prepared by Dr U Banasiak, Federal Institute for Risk Assessment, Berlin, Germany

Transcription

1 Trifloxystrobin 2 TRIFLOXYSTROBIN (2) The first draft was prepared by Dr U Banasiak, Federal Institute for Risk Assessment, Berlin, Germany EXPLANATION Trifloxystrobin was first evaluated for toxicology and residues by the JMPR in 24. The Meeting derived an ADI of.4 mg/kg bw per day and decided that an ARfD is unnecessary. Maximum residue levels, STMRs and STMR-Ps for commodities or commodity groups were estimated. In 24 the Meeting agreed that the residue definition for enforcement purposes for plant commodities should be trifloxystrobin per se, and that for animal commodities the residue definition should be parent compound and CGA 2 (expressed as trifloxystrobin equivalents). The Meeting agreed that the residue definition for consideration of dietary intake should consist of the parent compound and CGA 2 (expressed as trifloxystrobin equivalents). The compound was listed by the Forty-third Session of the CCPR for the review of additional MRLs. The 22 JMPR received residue data for strawberries, papaya, olives, tomato, lettuce, radish and asparagus. A re-consideration of the CXL of Brussels sprouts was requested by the company. RESIDUE ANALYSIS Analytical methods The Meeting received information on analytical methods for trifloxystrobin residues and its acid metabolite CGA 2 in plant materials. Some of the methods were evaluated by the 24 JMPR (de Haan, 22, Report No 2; Nuesslein, 22, method No 42, Report No MR -8/2; Nuesslein, 2, method No 42/E, Report No MR -2/). New submitted methods are briefly described below. The recoveries are summarised in Table. Method: 42/M Reference: Commodity: MR-/4, Edition No M Olive fruit, oil, pomace Analyte: Trifloxystrobin, CGA 2 LOQ: Determination: Description:.2 mg/kg HPLC-MS/MS Samples are extracted with acetonitrile/water. The extract is purified by liquid-liquid partition on ChemElut cartridge, thereby partitioning the analytes in a mixture of cyclohexane/ethyl acetate. The modification consists of use of stable isotopically labelled internal standard. The residues are quantified by reversed-phase HPLC with Turbo-Ionspray MS/MS-detection. Method: Reference: Commodity: MR-6/8, Edition No M Citrus fruit, pea green seed, wheat grain, rape seed, maize green material Analyte: Trifloxystrobin, CGA 2 LOQ: Determination: Description:. mg/kg HPLC-MS/MS Samples are extracted with acetonitrile/water. After filtration of the extract, the stable isotopically labelled analytes were added. The solution was made up to volume, diluted and subjected to reverse phase HPLC-MS/MS without a further clean-up step.

2 28 Trifloxystrobin Method: Reference: Commodity: ATM-./4 ATM-., ATM-.4 Strawberry Analyte: Trifloxystrobin, CGA 2 LOQ: Determination: Description:. mg/kg, recoveries were not reported GC-MS/MS Samples are extracted with acetonitrile/water (8:2 v/v). After cleaning with dichloromethane and water and a C8 solid phase extraction column with acetonitrile, the quantitation of residues was performed by GC-MS/MS. Method: Batelle Study No N Reference: RATFY2 Analytical Report, Batelle Study No N Commodity: Strawberry Analyte: Trifloxystrobin, CGA 2 LOQ:. mg/kg Determination: LC-MS/MS Description: Samples are extracted with acetonitrile/water (4:, v/v). After cleaning with.% formic acid in water and a C8 solid phase extraction column with acetonitrile, the quantitation of residues was performed by HPLC-electrospray ionisation/tandem mass spectrometry. Table Recoveries of trifloxystrobin and CGA 2 Analyte Matrix Fortification (mg/kg) Trifloxystrobin Citrus fruit.. Olive fruit Olive oil.2.2 Olive pomace Peas fruit.. Rape seed.. Strawberries Wheat grain.. Maize green. material. CGA 2 Citrus fruit.. Olive fruit Olive oil.2.2 Olive pomace n Recovery mean (%) RSD (%) Reference MR-6/8 MR-/4 MR-/4 MR-/4 MR-6/8 MR-6/8 RATFY2 Batelle Study No N MR-6/8 MR-6/8 MR-6/8 MR-/4 MR-/4 MR-/4

3 Trifloxystrobin 29 Analyte Matrix Fortification (mg/kg) Peas fruit.. Rape seed.. Strawberries Wheat grain.. Maize green. material. n Recovery mean (%) RSD (%) Reference MR-6/8 MR-6/8 RATFY2 Batelle Study No N MR-6/8 MR-6/8 Stability of residues in stored analytical samples Storage stability studies were conducted with trifloxystrobin in various plant materials. Results show that no significant decrease of residues was observed after the tested period of 8 or 24 months. Thus the residues of trifloxystrobin and CGA 2 are stable under freezer storage conditions for at least 24 months (grape fruit, cucumber fruit, potato, and wheat grain, straw and whole plant) or 8 months (apple fruit, apple wet pomace, peanut nutmeat, peanut oil, and grape juice). Hence, the results of storage stability studies validate the results from the residue trials with respect to the stability of trifloxystrobin and CGA 2 in frozen samples. Individual data on storage stability and the reports were reported by JMPR in 24. New storage stability data at temperatures of - to -2 C were submitted for papaya and asparagus. The data are summarised in Table 2. Table 2 Storage stability data for papaya and asparagus Matrix Analyte Fortification Residues remaining Storage Study No level (mg/kg) (mg/kg) (%) Papaya Trifloxystrobin IR-4-PR No CGA Asparagus Trifloxystrobin No CGA USE PATTERN The information available to the 22 JMPR on registered uses of trifloxystrobin is summarised in Table. Copies of labels were made available to the Meeting. Table Registered uses of trifloxystrobin. Crop Country Form Method F/G Application PHI, No kg ai/hl kg ai/ha days Asparagus USA WG foliar F PHI 9 days for California,.. 9/ 8 max.42 kg ai/ha per season Egg plant USA WG foliar F/G max.6 kg ai/ha..

4 24 Trifloxystrobin Crop Country Form Method F/G Application PHI, No kg ai/hl kg ai/ha days per season, e.g. 4. kg ai/ha Lettuce Netherlands WG foliar G.2 Switzerland WG foliar F.2.2 Switzerland WG foliar G Olives Spain WG foliar F st app. in spring, 2 nd in autumn 2. Papaya USA WG foliar F max..6 kg ai/ha 4. per season Radish USA WG foliar F max..28 kg ai/ha 4.. per year Strawberry Australia WG foliar.. Netherlands WG foliar.62 Switzerland WG foliar.2.2 USA WG foliar 6..2 Tomato USA WG foliar F/G max.6 kg ai/ha per season, e.g. 4. kg ai/ha.. RESIDUES RESULTING FROM SUPERVISED TRIALS ON CROPS The Meeting received information on supervised field trials for trifloxystrobin uses that produced residues in the following commodities. Commodity Codex No Group Table No Strawberry FB 2 Berries and other small fruits 4 Olives FT Assorted tropical and sub-tropical fruit edible peel Papaya FI Assorted tropical and sub-tropical fruit inedible peel 6 Tomatoes VO 448 Fruiting vegetables, other than cucurbits Lettuce, head VL 482 Leafy vegetables 8 Radish, leaves VL Radish VR 494 Root and tuber vegetables Asparagus VS 62 Stalk and stem vegetables Trials were well documented with laboratory and field reports. Laboratory reports included method validation with procedural recoveries from spiking at residue levels similar to those occurring in samples from the supervised trials. Dates of analysis or duration of residue sample storage were also provided. Undetected residues were generally reported lower than the LOQ. The corresponding data on the parent compound (molecular mass 48) and the trifloxystrobin acid CGA2 (molecular mass 94) are reported. The use of a conversion factor (.6) is not necessary for calculation of total residues. The sum of trifloxystrobin and CGA 2 was calculated according to the procedure described by 24 JMPR: As CGA 2 does not generally constitute a significant portion of the residues in crops, when the levels of trifloxystrobin or CGA 2 were below the LOQ, their sum was calculated as the examples below. Trifloxystrobin (mg/kg) CGA 2 (mg/kg) Total (mg/kg)

5 Trifloxystrobin 24 Residue values from the trials conducted according to maximum GAP have been used for the estimation of maximum residue levels. Those results included in the evaluation are underlined. If two field samples were taken or results of two replicate plots were submitted, the mean value was calculated for trifloxystrobin and the total residue only for trials according to GAP. Strawberry The use of trifloxystrobin in strawberry is registered in Australia, the USA, Switzerland, the Netherlands, and other countries. The Swiss use pattern and corresponding residue trials were previously submitted in 24 and resulted in the establishment of a Codex MRL of.2 mg/kg. The Australian and the US uses required a revision of that Codex MRL. Residue data are summarised below. The majority of the Australian trials were carried out with two replicated plots per treatment. Additionally, further replicates were conducted with different spray concentrations. In cases of replicates with the same application rate but different spray concentration, the highest residue value was used for the evaluation. Table 4 Trifloxystrobin residues in strawberries Country, year, location, (variety) Australia, 22 Bli Bli, QLD (Adina) Australia, 22 Bli Bli, QLD (Camarossa) Australia, 22 Wamuran, QLD Application Residues in mg/kg Report No. Form No kg ai/ha kg ai/hl PHI 2 Total Study No. WG.2.44 a WG.2.2 a a WG.2.44 a a WG a a WG.2. a BCS- AUS-BCS--A No GLP 2 replicate plots BCS- AUS-BCS--B No GLP 2 replicate plots BCS-2 AUS-BCS-2-A No GLP 2 replicate plots BCS-2 AUS-BCS-2-B No GLP 2 replicate plots BCS- AUS-BCS--A

6 242 Trifloxystrobin Country, year, location, (variety) Application Residues in mg/kg Report No. Form No kg ai/ha kg ai/hl PHI 2 Total Study No... (Camarossa) WG Australia, 22 Wamuran, QLD (Sweet Charlie) Australia, 22 Silvan, VIC (Selva) Australia, 2 Silvan, VIC (Selva) Australia, 2 Seville, VIC (Selva) a WG.2. a WG.2.4 a WG a WG.2.4 a WG..9.2 a WG.2. a WG.2. a /.8 b BCS- AUS-BCS--B BCS-4 AUS-BCS-4-A BCS- AUS-BCS--V AUS-BCS--V- A.appl BCS- AUS-BCS--V AUS-BCS--V- B.appl BCS- AUS-BCS--V2 AUS-BCS--V2- A.appl BCS- AUS-BCS--V2 AUS-BCS--V2- B.appl BCS- AUS-BCS--V AUS-BCS--V- A.appl. -- BCS- AUS-BCS--V4 AUS-BCS--V4- A.appl. -- Replicate to V-A Australia, 2 Seville, VIC (Selva).48.6 of V-A, V4-A WG.24.2 a.4. BCS-.4. AUS-BCS--V...8 AUS-BCS--V-.. B.6..appl WG.24.2 a.49. BCS-

7 Trifloxystrobin 24 Country, year, location, (variety) France 22 Germany 22 Germany 22 Switzerland 999 Switzerland 2 USA, 2 Penn Yan, NY (Honeye) USA, 26 Quitman, GA (Chandler) Application Residues in mg/kg Report No. Form No kg ai/ha kg ai/hl PHI 2 Total Study No. WG.2.4 WG.2.4 WG.2.4 WG.2.2 WG.2. WG 6..2 WG AUS-BCS--V4 AUS-BCS--V4- B.appl. -- Replicate to V-B of V-B, V4-B RA-28/2 8-2 Reported by 24 JMPR RA-28/2 8-2 Reported by 24 JMPR RA-28/ Reported by 24 JMPR 28/99 SWZ Reported by 24 JMPR 24/ SWZ-24- Reported by 24 JMPR RATFY2 TF2-H Duplicate samples RATFY2 TF22-H Duplicate samples USA, 2 Oviedo, FL (Sweet Charlie) WG RATFY2 TF2-H Duplicate samples USA, 2 New Era, MI (Allstar) WG RATFY2 TF24-H Duplicate samples USA, 2 Madera, CA (Quinalt) WG RATFY2 TF2-D Duplicate samples

8 244 Trifloxystrobin Country, year, location, (variety) USA, 26 Sanger, CA (Camarosa) USA, 26 Porterville, CA (Ozark Beauty) USA, 2 Covallis, OR (Puget Summer) Application Residues in mg/kg Report No. Form No kg ai/ha kg ai/hl PHI 2 Total Study No. a Residues before last treatment b Residues in untreated control WG WG WG , RATFY2 TF26-H samples RATFY2 TF2-H Duplicate samples RATFY2 TF28-H Duplicate samples Olives Eight trials on olives were carried out in Southern Europe in 2/4. Samples were analysed by analytical method 42/M at an LOQ of.2 mg/kg. In 28 and 29, four trials were conducted in Southern Europe. Residues were quantified by method with a LOQ of. mg/kg. The results are shown in Table. Due to the fact that residues of CGA 2 were below the LOQ at the recommended PHI, the trifloxystrobin data were used for the estimation of the STMR (total residues). Table Trifloxystrobin residues in olives Country, year, location, (variety) Spain, 24, E-4 St. Barbara (Morrut) Greece, 2, GR-28 Kovtalas- Korinthia (Manaki) Spain, 2, E-464 Osuna (Martena) Italy, 2, I- Andria (Coratina) Spain, 24, E-8292 Esparraguera (Vera) Trial No Form No kg ai/ha kg ai/hl Sample PHI WG.2.6 fruit 28 WG.6. fruit a 28 WG.6. fruit WG.6. fruit WG.6. fruit RA-2/ 9- RA-2/ 8- RA-2/ 8- RA-2/ 82- RA-2/4 4-4 Greece, 24, WG.6. fruit.2 RA-2/4

9 Trifloxystrobin 24 Country, year, location, (variety) GR- Livanates (Kalamon) Italy, 24, I- Andria (Coratina) Portugal, 24, P-2 Povoa de Santarem (Galega) Spain, 28, E-4 St. Barbara (Morrut) Trial No Form No kg ai/ha kg ai/hl Sample PHI WG.6. fruit 28 WG.6. fruit 28 WG fruit a Italy, 28, WG fruit a I-9 Catania (Bella die Spagna) Spain, 29, WG fruit a E-89 St.Llorenc d Hortons (Arbequina) Portugal, WG fruit a 29, P-2-2 Santarem (Galega) a before last treatment RA-2/ RA-2/ Spraying interval 82 days Spraying interval 84 days Spraying interval 99 days Spraying interval days Papaya Four trials on papaya located in the USA were submitted (see Table 6). In each trial, four applications of trifloxystrobin to 8 days apart were made. The application rates ranged from. to. kg ai/ha per treatment for a total rate range of.6 to.84 kg ai/ha per season. The samples were harvested on the day of the last application and analysed by method No. AG-69A, as reported by the 24 JMPR. The storage interval for field-treated samples ranged from 468 days to 4 days. Storage stability data were submitted and show that the residues are stable under the storage conditions. Table 6 Trifloxystrobin residues in papaya fruits Country, year, location, (variety) USA, 2, Homestead, FL (Red Lady) Form No kg ai/ha kg ai/hl PHI 2 Total Field-ID-No, WG IR-4-PR No.9, 9.-FL, Last appl. --2,

10 246 Trifloxystrobin Country, year, location, (variety) USA, 2, Homestead, FL, (Red Lady) USA, 2, Haleiwa, HI 962, (Gold) USA, 2, Keaau, HI 9649, (Kapoho) Form No kg ai/ha kg ai/hl PHI 2 Total Field-ID-No, WG WG WG IR-4-PR No.9, 9.-FL8, Last appl , IR-4-PR No.9, 9.-HI, Last appl. -6-2, IR-4-PR No.9 9.-HI4 Last appl. -- 2, Tomatoes The 24 JMPR evaluated 8 trials on tomatoes. Six further trials were conducted in the USA in 28, three each with WG and SC formulation. The residues of trifloxystrobin and CGA 2 were determined according to method No. 2 with a LOQ of. mg/kg (JMPR 24). The results are shown in Table. Due to the fact that residues of CGA 2 were below the LOQ at the recommended PHI, the trifloxystrobin data were used for the estimation of the STMR (total residues). Table Trifloxystrobin residues in tomatoes Country, Year, Location, (Variety) USA, 28, San Joaquin, CA, (Heinz) USA, 28, San Joaquin, CA, (Heinz) USA, 28, Kettleman City, CA (CXD-8) USA, 28, Kettleman City, CA, (CXD-8) USA, 28, Oviedo,FL (Better Boy) USA, 28, Oviedo, FL (Better Boy) Form No kg ai/ha kg ai/hl Sample PHI 2 Trial No, WG 4..2 Fruit SC 4.. WG SC Fruit Fruit Fruit WG 4..9 Fruit SC Fruit RAGMP26, GM-8BA 2 replicate plots RAGMP26 GM-8BA 2 replicate plots RAGMP26 GM2-8BA 2 replicate plots RAGMP26 GM2-8BA 2 replicate plots RAGMP26 GM-8BA 2 replicate plots RAGMP26 GM-8BA 2 replicate plots

11 Trifloxystrobin 24 Lettuce, Head Indoor residue trials on lettuce were carried out in 22 in European countries. The spray intervals between applications were days. The residues of trifloxystrobin and its metabolite CGA 2 were determined according to method 42 with a LOQ of.2 mg/kg. The results are summarised in Table 8. Table 8 Residues of trifloxystrobin in head lettuce, carried out in greenhouse Country, Year, Location, (Variety) France, 22, F-9 St Jory, (Garuda) France, 22, F-84 Montfavet, (Sansai) Germany, 22, D-464 Langenfeld, (Roderick) Germany, 22, D-4299 Leichlingen, (Histor) Italy, 22, I- Zapponeta, (Rosella) Italy, 22, I- Palidoro- Fumicino, (Romaserra) Netherlands, 22, NL-69 Wefershoof, (Alexandria) Portugal, 22, P-2-68 Povoa (Angiew) Form No kg ai/ha Growth stage PHI 2 Total Trial No WG.2 4 WG.2 48 WG.2 4 WG.2 4 WG.2 4 WG.2 48 WG.2 42 WG RA-26/2 2-2 RA-26/2-2 RA-26/2-2 RA-26/2-2 RA-26/2 8-2 RA-26/2-2 RA-26/2-2 RA-26/2 6-2 Radish Six trials on radish located in the USA were submitted. At each trial, two foliar directed applications of trifloxystrobin to 8 days apart were made. The application rates ranged from. to. kg ai/ha per treatment for a total rate range of.28 to. kg ai/ha per season or from.28 to. kg ai/ha per treatment for a total rate range of. to.9 kg ai/ha per season. Samples were taken for tops (leaves) and roots, the results are shown in tables 9 and, respectively. Table 9 Trifloxystrobin residues in radish tops Country, Year, Location, (Variety) USA, 22, Holtville, CA, Form No kg ai/ha PHI 2 Total Trial No, WDG No. 86,

12 248 Trifloxystrobin Country, Year, Location, (Variety) Form No kg ai/ha PHI 2 Total Trial No, (Cherry Belle) CA6 WDG USA, 22, Citra, FL, (Cabernet F) WDG USA, 22, Citra, FL, (Cabernet F) USA, 22, Freeville, NY, (Cherriette F) USA, 22, Aurora, OR, (Rebel) USA, 22, Arlington, WI, (Cornet) WDG WDG 2.. WDG WDG 2.. WDG WDG 2.. WDG WDG 2.. WDG No. 86, FL48 Last application /9/2 No. 86, FL49 Last application //2 No. 86, NY9 No. 86, OR22 No. 86, WI Table Trifloxystrobin residues in radish roots Country, Year, Location, (Variety) USA, 22, Holtville, CA, (Cherry Belle) USA, 22, Citra, FL, (Cabernet F) USA, 22, Citra, FL, (Cabernet F) USA, 22, Freeville, NY, (Cherriette F) USA, 22, Aurora, OR, (Rebel) Form No kg ai/ha PHI 2 Total Trial No, WDG 2.. WDG 2.. WDG 2.. WDG WDG 2.. WDG WDG 2.. WDG WDG No. 86, CA6 No. 86, FL48 Last application /9/2 No. 86, FL49 Last application //2 No. 86, NY9 No. 86, OR22

13 Trifloxystrobin 249 Country, Year, Location, (Variety) USA, 22, Arlington, WI, (Cornet) Form No kg ai/ha PHI 2 Total Trial No, WDG WDG 2.. WDG No. 86, WI Asparagus Seven trials on asparagus located in the USA were submitted. At each trial, three foliar directed applications of trifloxystrobin to days apart were made. The application rates ranged from. to. kg ai/ha per treatment for a total rate range of.42 to.4 kg ai/ha per season. Samples were analysed by method AG-69A which was reported by the 24 JMPR. Table Trifloxystrobin residues in asparagus. Country, Year, Location, (Variety) USA, 22, Stockton, CA, (UC) USA, 22, San Ardo, CA, (UC) USA, 22, Caldwell, ID, (Jersey King) USA, 22, Holt, MI, (Jersey Knight) USA, 22, East Lancing, MI, (Jersey Gigant) USA, 22, Bridgeton, NJ, (New Jersey Male Hybrids) USA, 22, Moxee, WA, (Mary Washington) Form No kg ai/ha PHI Sample 2 Trial No, WG... WG... WG... WG... WG... WG... WG Spears <. <. <. <. Spears <. <. 6 Spears <. <. 8 Spears <. <. 6 Spears <. <. 8 Spears <. < Spears <. <. No. 822, CA No. 822, CA8 No. 822, ID No. 822, MI2 No. 822, MI26 No. 822, NJ29 No. 822, WA FATES OF RESIDUES IN STORAGE AND PROCESSING In processing The effect of processing on trifloxystrobin residues was investigated in strawberries and olives. Strawberries One processing study (RA-8/2, 2 European trials) was reported by the 24 JMPR. One further study was conducted in 26 in the USA to determine trifloxystrobin residues in strawberry washed or cooked fruit (jam) following treatment with trifloxystrobin WG. Six spray applications at a rate of. kg ai/ha were made with a to -day interval between applications. Strawberry fruits were harvested at the day of the last application (PHI of days). The harvested fruits were washed and cooked with fruit pectin and sugar. The results are shown in Table 2.

14 2 Trifloxystrobin Table 2 Residues of trifloxystrobin in strawberry fruit and processed products, report RATFY2 Country, Year, Location, (Variety) USA, 26, Sanger, CA (Camarosa) Application Form No kg ai/ha Growth stage Residues in mg/kg Sample WG Fruit Fruit, washed Jam PHI Trifloxystr obin CGA Total residue.2..2 Olives The purpose of the studies submitted was to determine the magnitude of residues of trifloxystrobin in/on olive fruit and processed products as washed fruit, press cake (pomace, wet), crude oil, preclarified crude oil, neutralised crude oil and refined oil. Trifloxystrobin WG was applied once to olive trees at about.% spray concentration (product rate of about.2 kg/ha, water rate of 2L/ha), corresponding to a rate of active substance of about.6 kg ai/ha. The application was carried out at days prior to the expected date of harvest (PHI days). The olives were washed in standing water by moving them around slowly. The washed olives were crushed into olive pulp in a cutter. Salt was added to the olive pulp and then the olive pulp was pressed into press cake and a water/oil emulsion. The wet pomace was sampled. The water/oil emulsion was separated into crude oil and vegetation water in a separating funnel (further cleaning by centrifugation). Crude oil was pre-clarified by heating ( min at approx. 8 9 C) in the presence of water and citric acid solution. The remaining part of the pre-clarified oil was transferred into the neutralization apparatus and heated up to 9 C while stirring. After addition of 6% (w/w) sodium hydroxide, the stirring was stopped. Within a few minutes, the free fatty acids are converted into their sodium soaps and soap stock is formed. After removal of the soap stock the oil was centrifuged in order to remove remaining rests of the soap stock. Neutralised crude oil was transferred into a bleaching flask and heated up to 8 9 C while stirring. After the addition of. 2.% (w/w) fuller's earth, the oil was stirred for about minutes. Basically, the following distillation (. h, 22 C) was a steam distillation. The steam is formed in a steam-generating tube which extends into the hot oil. The steam removes the constituents that are volatile in water vapour from the oil. It condenses in a separate flask via a cooler. After cooling, the refined oil was sampled. The results are shown in Table. Because of the fact that the CGA 2 residues were below or at the LOQ at the recommended PHI, the trifloxystrobin data corresponded to the total residues. Table Residues of trifloxystrobin in olives and processed products, PHI fruits days Country, Year, Location, (Variety) Spain, 24, E-4 St. Barbara (Morrut) Greece, 2, GR-28 Kovtalas- Korinthia (Manaki) Form No kg ai/ha kg ai/hl Sample Trifloxystr obin CGA 2 Trial No WG..6 Fruit Whole fruit, washed Separation water Washings Pomace, wet Oil, crude Crude oil, pre-clarified Crude oil, neutralised Oil, refined WG.6. Fruit Whole fruit, washed Separation water Washings Pomace, wet Oil, crude Crude oil, pre-clarified RA-/ 9- RA-/ 8-

15 Trifloxystrobin 2 Country, Year, Location, (Variety) Italy, 24, I- Andria (Coratina) Portugal, 24, P-2 Povoa de Santarem (Galega) Form No kg ai/ha kg ai/hl Sample Trifloxystr obin CGA 2 Trial No Crude oil, neutralised Oil, refined WG.6. Fruit Whole fruit, washed Separation water Washings Pomace, wet Oil, crude Crude oil, pre-clarified WG.6. Fruit Whole fruit, washed Separation water Washings Pomace, wet Oil, crude Crude oil, pre-clarified RA / RA /4-4 The processing factors shown below were calculated from the total residue levels (sum of trifloxystrobin and CGA 2). Table Summary of processing factors for trifloxystrobin total residues Raw agricultural commodity Best estimate Processed commodity Calculated processing factors (RAC) (mean or median) Strawberry Strawberry jam.2,.8 a,.66 a.8 Strawberry preserves.2 a,. a.29 Olives Olive oil, crude.9, 2.,.,.. Olive oil, refined., a reported by JMPR in 24 APPRAISAL Trifloxystrobin was first evaluated for toxicology and residues by the JMPR in 24. The Meeting derived an ADI of.4 mg/kg bw per day and decided that an ARfD is unnecessary. Maximum residue levels, STMRs and STMR-Ps for commodities or commodity groups were estimated. In 24 the Meeting agreed that the residue definition for enforcement purposes for plant commodities should be trifloxystrobin per se. For enforcement of animal commodities and for consideration of dietary intake of plant or animal commodities the residue definition should be parent compound and (E,E)-methoxyimino-{2-[-(-trifluoromethyl-phenyl) ethylideneaminooxymethyl]- phenyl}acetic acid) (expressed as trifloxystrobin equivalents). The metabolite is also known as CGA 2. The compound was listed by the Forty-third Session of the CCPR for the review of additional MRLs. The 22 JMPR received residue data for strawberries, papaya, olives, tomato, lettuce, radish and asparagus. Methods of analysis The Meeting received information on analytical methods used for the determination of trifloxystrobin residues and its acid metabolite CGA 2 in samples derived from supervised trials on asparagus, lettuce, olives, papaya, radish, strawberry and tomatoes. The residues were determined by LC-MS/MS or GC-MS/MS with LOQs of..2 mg/kg. The freezer storage stability studies carried out with asparagus and papaya showed that the trifloxystrobin residues and the metabolite CGA 2 were stable for the longest period for which

16 22 Trifloxystrobin the samples were stored at or below - C. The studies reported by the 24 JMPR cover the other sample materials evaluated by the present Meeting. Results of supervised residue trials on crops The OECD calculator was used as a tool in the estimation of the maximum residue level from the selected residue data set obtained from trials conducted according to GAP. As a first step, the Meeting reviewed all relevant factors related to each data set in arriving at a best estimate of the maximum residue level using expert judgment. Then, the OECD calculator was employed. If the statistical calculation spreadsheet suggested a different value from that recommended by the JMPR, a brief explanation of the deviation was provided. Strawberry Based on the Swiss GAP (.2 kg ai/ha, PHI days) and five European supervised trials, the 24 JMPR estimated a maximum residue level of.2 mg/kg and an STMR of. mg/kg. The 22 Meeting received additional residue data from the USA and Australia. The Australian trials were carried out with.2 kg ai/ha and did not match the GAP (. kg ai/ha, PHI day). The registered GAP in the USA is 6. kg ai/ha and a -day PHI. In eight trials matching GAP conditions, the residue levels of trifloxystrobin per se were (n=8):.,.9,.2,.28,.,.44,.4 and. mg/kg. The residue concentrations of the sum of trifloxystrobin and CGA 2 were:.2,.2,.2,.,.6,.4,. and.6 mg/kg. The Meeting estimated a maximum residue level of mg/kg and an STMR of. mg/kg for trifloxystrobin in strawberries to replace the former recommendation. Olives The Spanish GAP is 2. kg ai/hl and a PHI of days. The first application is recommended in spring, the second in autumn. Eight trials conducted in Southern Europe with one treatment of. kg ai/hl in autumn and a PHI of days showed residues of trifloxystrobin per se of.4,.,.,.,.,.,.2 and. mg/kg. In four Southern European trials with two applications (one in spring and one in autumn with.6 kg ai/hl, spraying interval of 99 days between the two treatments), the residue levels of trifloxystrobin per se were.2,.4,. and. mg/kg. The Meeting noticed that the first spray treatment did not influence the residue concentration and decided to combine the two datasets. The trifloxystrobin residues (n=2) were:.2,.4,.4,.,.,.,.,.,.,.2,. and. mg/kg. Because the residues of CGA 2 were below the LOQ, for estimation of STMR (sum of parent and CGA 2), the trifloxystrobin data were used. The Meeting estimated a maximum residue level of. mg/kg and an STMR of.8 mg/kg for trifloxystrobin in olives. Papaya The GAP in the USA is maximal four foliar applications of. kg ai/ha at a maximal seasonal rate of.6 kg ai/ha and a PHI of days. Four trials were conducted on papaya in the USA in 2 with foliar treatment by 4.. kg ai/ha, PHI days. The trifloxystrobin residues were.,.,.22 and.2 mg/kg. The residue concentrations of the sum of trifloxystrobin and CGA 2 were:.,.,.2 and. mg/kg. The Meeting estimated a maximum residue level of.6 mg/kg and an STMR of.2 mg/kg for trifloxystrobin in papaya. Brussels sprouts The 24 JMPR estimated a maximum residue level of. mg/kg and a STMR of. mg/kg for residues of trifloxystrobin in flowerhead brassica, Brussels sprouts and head cabbage but in the CCPR

17 Trifloxystrobin 2 reports, a CXL of. mg/kg was listed for Brussels sprouts. The company requested a clarification. No new data were submitted. The current Meeting noted that the value of. mg/kg as CXL for Brussels sprouts is an administrative error in the Codex System. The MRL recommendation made by the 24 JMPR was. mg/kg. Tomatoes Based on the US GAP (4. kg ai/ha, PHI days) and 8 supervised trials, the 24 JMPR estimated a maximum residue level of. mg/kg and an STMR of.8 mg/kg. The 22 JMPR received six further US outdoor trials according to US GAP. The residue concentrations of the sum of trifloxystrobin and CGA 2 were:.,.4,.6,.6,.9 and. mg/kg. The Meeting agreed that a new recommendation for trifloxystrobin on tomatoes based on the data submitted to the 22 JMPR was not necessary. Therefore, the previous recommendations for a maximum residue level and STMR were maintained. Egg plant The US GAP of trifloxystrobin on eggplant is.. kg ai/ha at a maximum of.6 kg ai/ha per season and a day PHI, the same GAP is registered for tomatoes. The Meeting agreed to extrapolate from tomato to eggplant and recommended a maximum residue level of. mg/kg and an STMR of.8 mg/kg for trifloxystrobin in egg plant. Lettuce, Head The GAP for greenhouse grown lettuce is in the Netherlands.2 kg ai/ha and a PHI of days. Eight indoor European trials (France (2), Germany (2), Italy (2), Portugal (), the Netherlands ()) treated with.2 kg ai/ha were received. In eight trials on head lettuce matching the GAP conditions of the Netherlands (application rate +2 %), the residue levels of trifloxystrobin per se were: 2.4, 2., 2.,.4,.6,., 6.6 and.2 mg/kg. The residue concentrations of the sum of trifloxystrobin and CGA 2 were: 2.4, 2., 2.,.4,.,.8, 6. and.2 mg/kg. The Meeting estimated a maximum residue level of mg/kg and an STMR of. mg/kg for trifloxystrobin in lettuce, head. Radish leaves (including Radish tops) The registered GAP on radish in the USA is 4.. kg ai/ha at a maximal rate of.28 kg ai/ha per year and a PHI of days. Six field trials were conducted with 2.. kg ai/ha and a PHI of 6 8 days. In radish tops, the residue levels of trifloxystrobin per se were:.,.22,.26, 2.,. and 6.8 mg/kg. The residue concentrations of the sum of trifloxystrobin and CGA 2 were:.,.2,., 2.4,.4 and.2 mg/kg. The Meeting estimated a maximum residue level of mg/kg and an STMR of.4 mg/kg for trifloxystrobin in radish leaves. Radish The registered GAP on radish in the USA is 4.. kg ai/ha at a maximal rate of.28 kg ai/ha per year and a PHI of days. Six field trials were conducted with 2.. kg ai/ha and a PHI of 6 8 days.

18 24 Trifloxystrobin In radish roots, the residue levels of trifloxystrobin per se were: (),.,.4 and. mg/kg. The residue concentrations of the sum of trifloxystrobin and CGA 2 were:,.6,.6 and. () mg/kg. The Meeting estimated a maximum residue level of.8 mg/kg and an STMR of.6 mg/kg for trifloxystrobin in radish. Asparagus The GAP in the USA is.. kg ai/ha at a maximal seasonal rate of.42 kg ai/ha and a PHI of 8 days (California 9 days). Seven trials were conducted on asparagus in the USA in 22 with foliar treatment by.. kg ai/ha and PHIs of days. In the sprouts, neither residues of trifloxystrobin (<. mg/kg) nor the metabolite CGA 2 ( mg/kg) were detected. The Meeting estimated a maximum residue level of.* mg/kg and an STMR of for trifloxystrobin in asparagus. Fate of residues during processing The effect of processing on the level of residues of trifloxystrobin and the metabolite CGA 2 has been studied for strawberries and olives. The processing factors (PF) were calculated from the total residue levels (sum of trifloxystrobin and CGA 2). The best estimates of the processing factors are shown below. Processes included in the table are those that lead to STMR-P values useful for dietary intake estimations. Raw agricultural Best estimate RAC Processed commodity commodity (RAC) processing factor (PF) STMR STMR-P Strawberry Strawberry jam Strawberry preserves.29.9 Olives Olive oil, crude.8.2 Olive oil, refined 4.. The Meeting estimated the following STMR-P values:.94 mg/kg for strawberry jam,.9 mg/kg for strawberry, canned,.2 mg/kg for olive oil, crude and. for olive oil, refined. A maximum residue level for the processed commodity will only be recommended if the resulting residue value is higher than the maximum residue level proposed for the corresponding RAC. Because of the fact that the PF is > for olive oils and the oils are commodities in trade, maximum residue levels were proposed for olive oil, crude and olive oil, refined. The Meeting estimated a maximum residue level for olive oil, crude of.9 mg/kg and for olive oil, refined of.2 mg/kg. Residues in animal commodities As the commodities evaluated by the 22 JMPR are not included in the OECD farm animal feeding table, there is no need to re-calculate the farm animal dietary burden. The Meeting concluded that a re-evaluation of the maximum residue levels for animal commodities was not necessary. RECOMMENDATIONS On the basis of the data from supervised trials the Meeting concluded that the residue levels listed below are suitable for establishing maximum residue limits and for IEDI assessment. Definition of the residue for plant commodities for compliance with the MRL: Trifloxystrobin Definition of the residue for plant commodities for estimation of dietary intake: Sum of trifloxystrobin and (E,E)-methoxyimino-{2-[-(-trifluoromethyl-phenyl) ethylideneaminooxymethyl]- phenyl}acetic acid) (CGA 2), expressed as trifloxystrobin.

19 Trifloxystrobin 2 Definition of the residue for animal commodities for compliance with the MRL and for dietary intake: Sum of trifloxystrobin and (E,E)-methoxyimino-{2-[-(-trifluoromethyl-phenyl) ethylideneaminooxymethyl]-phenyl}acetic acid) (CGA 2), expressed as trifloxystrobin. The residue is fat-soluble. Commodity Recommended MRL, mg/kg STMR or STMR-P CCN Name proposed previous mg/kg VS 62 Asparagus.* VO 44 Egg plant..8 VL 482 Lettuce, head. FT Olives..8 OC Olive oil, crude.9.2 OR Olive oil, refined.2. FI Papaya.6.2 VL 494 Radish leaves (including.4 Radish tops) VR 494 Radish.8.6 FB 2 Strawberry.2. Strawberry, canned.9 Strawberry jam.94 Long-term intake DIETARY RISK ASSESSMENT The International Estimated Daily Intakes (IEDIs) of trifloxystrobin were calculated for the GEMS/Food cluster diets using STMRs and STMR-Ps estimated by the JMPR in 24 and 22. The results are shown in Annex of the JMPR 22 Report. The ADI is.4 mg/kg bw and the calculated IEDIs were % of the maximum ADI. The Meeting concluded that the long-term intake of residues of trifloxystrobin from the uses considered by the JMPR is unlikely to present a public health concern. Short-term intake The 24 JMPR decided that it was unnecessary to establish an ARfD. The present Meeting therefore concluded that the short-term intake of trifloxystrobin residues is unlikely to present a public health concern. REFERENCES Code Author Year Title, Institute, Report reference 8-22 Schmeer, K & Kuppels, U 2 Determination of the residues of trifloxystrobin in/on olive after spraying of trifloxystrobin WG in the field in Italy, Portugal and Spain. Bayer CropScience AG, Edition No M-6--. Unpublished. 9-2 Bomke, S 2 Determination of the residues of trifloxystrobin in/on olive after spraying of trifloxystrobin WG in the field in Greece, Italy, Portugal and Spain. Bayer CropScience AG, Edition No M Unpublished. ATM-. Anonymous 2 Determination of trifloxystrobin (CGA 2922) and metabolite CGA 2 in water crops, codex group 2 (strawberries), by GC MS/MS. Analytical test method ATM-./MO-4-6. Issued: 6/4/, revision:. Bayer CropScience AG, Edition No MO-4-6. Unpublished. ATM-.4 Anonymous 2 Determination of trifloxystrobin (CGA 2922) and metabolite CGA

20 26 Trifloxystrobin Code Author Year Title, Institute, Report reference 2 in water crops, codex group 2 (strawberries), by GC MS/MS. Analytical test method ATM-.4/MO Issued: 29/9/, revision: 4. Bayer CropScience AG, Edition No MO Unpublished. BCS- Radunz, L 2 Determination of residues of trifloxystrobin in strawberries following three applications of Flint WG at two rates sprayed by concentrate or dilute application at weekly intervals. Bayer CropScience AG, Edition No MO-4-8. Unpublished. BCS-2 Radunz, L 2 Determination of residues of trifloxystrobin in strawberries following three applications of Flint WG at two rates sprayed by concentrate or dilute application at weekly intervals. Bayer CropScience AG, Edition No MO Unpublished. BCS- Radunz, L 2 Determination of residues of trifloxystrobin in strawberries following three applications of Flint WG at two rates sprayed by concentrate or dilute application at weekly intervals. Bayer CropScience AG, Edition No MO-4-8. Unpublished. BCS-4 Radunz, L 2 Determination of residues of trifloxystrobin in strawberries following three applications of Flint WG at two rates sprayed by concentrate or dilute application at weekly intervals. Bayer CropScience AG, Edition No MO Unpublished. BCS- Radunz, L 2 Determination of residues of trifloxystrobin in strawberries following three applications of Flint WG at two rates sprayed by concentrate or dilute application at weekly intervals. Bayer CropScience AG, Edition No MO-4-8. Unpublished. IR-4-PR No. 9 Corley, J 26 Trifloxystrobin: Magnitude of the residues on papaya. IR-4 Project No 9. Unpublished. No. 822 Corley, J 26 Trifloxystrobin: Magnitude of the residues on asparagus. No 822. Unpublished. No. 86 Corley,. 26 Trifloxystrobin: Magnitude of the residues on radish. No 86. Unpublished. MR-/4 MR-6/8 RA-2/4 Zimmer, D & Kuppels, U Brumhard, B & Stuke, S Zimmer, D & Eberhardt, R. 2 Modification M of the method 42 for the determination of residues of Trifloxystrobin and its metabolite CGA 2 in/on sample materials of olive by HPLC-MS/MS. Bayer CropScience AG, Edition No M Unpublished. 2 Analytical method for the simultaneous determination of residues of the active items BYF8, prothioconazole, tebuconazole, trifloxystrobin and the metabolites BYF8-desmethyl, JAU646- desthio (SXX66) and CGA 2 in/on plant material by HPLC- MS/MS. Bayer CropScience AG, Edition No M Unpublished. 26 Determination of the residues of trifloxystrobin in/on olive after spraying of Flint ( WG) in the field in Spain, Greece, Italy and Portugal. Bayer CropScience AG, Edition No M Unpublished. RA-26/2 Nuesslein, F 2 Determination of residues of trifloxystrobin and CGA 2 in/on lettuce following spray application of Flint WG in the greenhouse in Southern France, Germany, Italy, Netherlands and Portugal.. Bayer CropScience AG, Edition No MO--2. Unpublished. RA-2/ Zimmer, D 2 Determination of the residues of trifloxystrobin in/on olive after spraying of Flint ( WG) in the field in Spain, Greece and Italy. Bayer CropScience AG, Edition No MO--46. Unpublished. RA-/4 Zimmer, D & Eberhardt, R 26 Determination of the residues of trifloxystrobin in/on olive and the processed fractions (crude oil; vegetation water; washings; pomace, wet; crude oil, pre-clarified; fruit, washed) after spraying of Flint ( WG) in the field in Italy and Portugal. Bayer CropScience AG, Edition No M Unpublished.

21 Trifloxystrobin 2 Code Author Year Title, Institute, Report reference RA-/ Zimmer, D 2 Determination of the residues of trifloxystrobin in/on olive and processed commodities after spraying of Flint ( WG) in the field in Spain and Greece. Bayer CropScience AG, Edition No MO--48. Unpublished. RAGMP26 Netzband, D & Abele, R 29 Gem SC and Flint WG Magnitude of the residue in/on tomatoes. Bayer CropScience AG, Edition No M-8--. Unpublished. RATFY2 Krolski, ME 26 Flint WG Magnitude of the residue in/on strawberries. Bayer CropScience AG, Edition No M Unpublished. Klein, O 22 Letter by Otto Klein, Bayer CropScience, to Yang, YongZhen, May 22. CXL for trifloxystrobin on Brussels sprouts.