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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex B 

Spirotetramat 

B.7 Residue data 

Reviewed by: 

PMRA, Canada (B.7.1, B.7.2, B.7.3, B.7.5, B.7.7.2.1, B.7.8, B.7.9, Annex II) 

AGES, Austria, (B.7.4, B.7.5, B.7.6, B.7.7.1, B.7.7.2.2, B.7.10, B.7.11, B.7.12, 

B.7.13, B.7.14, B.7.15, B.7.16, Annex I) 

PSD, UK (Annex III) 

Peer – reviewed by: 

US EPA, USA 

PMRA, Canada

AGES, Austria
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7 Residue data............................................................................................................................1

B.7.1 Metabolism, distribution and expression of residues in plants (Annex IIA 6.2; Annex 

IIIA, 8.1) ....................................................................................................................................5

B.7.1.1 Metabolism in cotton.................................................................................................................5

B.7.1.2 Metabolism in lettuce ................................................................................................................9

B.7.1.3 Metabolism in potato...............................................................................................................10

B.7.1.4 Metabolism in apple................................................................................................................12

B.7.1.5 Overall conclusion on the metabolic fate on crops.................................................................14

B.7.2 Metabolism, distribution and expression of residues in livestock (Annex IIA 6.2; Annex 

IIIA, 8.1) ..................................................................................................................................16

B.7.2.1 Metabolism in lactating goat ...................................................................................................16

B.7.2.2 Metabolism in laying hen ........................................................................................................18

B.7.2.3 Overall conclusion on the metabolic fate in livestock animals:...............................................19

B.7.3 Definition of the residue (Annex IIA 6.7; Annex IIIA 8.7) ........................................................25

B.7.4 Use pattern for European Trials..............................................................................................25

B.7.5 Intended uses of spirotetramat i.e. supported uses for evaluation under Directive 

91/414/EEC and for NAFTA ...................................................................................................27

B.7.6 Residues resulting from supervised trials (Annex IIA 6.3; Annex IIIA 8.3).............................38

B.7.6.1 Citrus fruits..............................................................................................................................38

B.7.6.2 Lettuce ....................................................................................................................................45

B.7.6.3 Pome fruit................................................................................................................................51

B.7.6.4 Stone fruit................................................................................................................................58

B.7.6.4.1 Peach and apricot...................................................................................................................58

B.7.6.4.2 Plum........................................................................................................................................63

B.7.6.4.3 Cherry .....................................................................................................................................67

B.7.6.5 Berries and small fruits ...........................................................................................................71

B.7.6.5.1 Grapes ....................................................................................................................................71

B.7.6.5.2 Strawberry...............................................................................................................................75

B.7.6.6 Bulb vegetable ........................................................................................................................80

B.7.6.6.1 Onion ......................................................................................................................................80

B.7.6.7 Fruiting vegetables..................................................................................................................84

B.7.6.7.1 Tomato....................................................................................................................................84

B.7.6.7.2 Pepper ....................................................................................................................................88

B.7.6.7.3 Cucumber ...............................................................................................................................94

B.7.6.7.4 Melons ....................................................................................................................................99

B.7.6.8 Brassica vegetables..............................................................................................................105

B.7.6.8.1 Flowering brassica................................................................................................................105

B.7.6.8.2 Head brassica.......................................................................................................................110

B.7.6.8.3 Leafy brassica.......................................................................................................................118

B.7.6.8.4 Kohlrabi.................................................................................................................................122

B.7.6.9 Green bean (fresh, with pods) ..............................................................................................126

B.7.6.10 Hops......................................................................................................................................128

B.7.6.11 Overall conclusion.................................................................................................................132

B.7.6.12 Stability of residues prior to analysis ....................................................................................133

B.7.6.12.1 Storage stability in plant commodities ..................................................................................133

B.7.7 Effects of industrial processing and/or household preparation (Annex IIA 6.5; Annex 

IIIA 8.5) .................................................................................................................................138

B.7.7.1 Effects on the nature of the residue......................................................................................138

B.7.7.1.1 BYI 08330 .............................................................................................................................138

B.7.7.1.2 BYI 08330-enol .....................................................................................................................140
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.7.1.3 BYI 08330-enol-glucoside.....................................................................................................142

B.7.7.1.4 BYI 08330-keto-hydroxy .......................................................................................................144

B.7.7.1.5 BYI 08330-mono-hydroxy.....................................................................................................147

B.7.7.2 Residue levels - balance studies on set of representative processes..................................149

B.7.7.2.1 Residue levels - balance studies on set of representative processes with relevance for 

PMRA (Canada) and USEPA: ..............................................................................................149

B.7.7.2.2 Residue levels - balance studies on set of representative processes with relevance for 

the European Community (EU).............................................................................................158

B.7.8 Livestock feeding studies (Annex IIA 6.4; Annex IIIA 8.4)....................................................188

B.7.9 Residues in succeeding crops or rotational crops (Annex IIA 6.6; Annex IIIA 8.6) ..............192

B.7.9.1 Confined rotational crop study using radiolabelled material.................................................192

B.7.9.2 Crop rotation studies (field test)............................................................................................197

B.7.9.3 Overall conclusion.................................................................................................................200

B.7.10 Proposed pre-harvest intervals for envisaged uses, or withholding periods, in the case 

of post harvest uses (Annex IIA 6.8; Annex IIIA 8.8)............................................................200

B.7.11 Community MRL and MRLs in EU Member States (Annex IIIA 11.2)..................................201

B.7.12 Proposed EU MRLs and justification for the acceptability of those MRLs (Annex IIA 

6.7; Annex IIIA 8.7) ...............................................................................................................201

B.7.12.1 Food of animal origin ............................................................................................................201

B.7.13 Proposed EU import tolerances and justification for the acceptability of those residues.....202

B.7.14 Basis for differences, if any, in conclusions reached having regard to established or 

proposed CAC MRLs............................................................................................................203

B.7.15 Estimates of potential and actual dietary exposure through diet and other means 

(Annex IIA 6.9; Annex IIIA 8.10) ...........................................................................................203

B.7.15.1 Estimation of the potential and actual exposure through diet...............................................203

B.7.15.2 Estimation of chronic exposure through diet ........................................................................203

B.7.15.2.1 Estimation of acute exposure through diet ...........................................................................204

B.7.15.3 Estimation of the potential and actual exposure through other means ................................205

B.7.16 Summary and evaluation of residue behaviour (Annex IIA 6.11.1; Annex IIIA 8.11) ...........205

B.7.17 References relied on.............................................................................................................212

Annex I a: Summary of trial information – citrus fruits....................................................................................247

Annex I b: Summary of trial information - lettuce ...........................................................................................253

Annex I c: Summary of trial information – pome fruit .....................................................................................258

Annex I d: Summary of trial information – Peach and apricot........................................................................263

Annex I e: Summary of trial information – Plum.............................................................................................266

Annex I f: Summary of trial information – Cherry ...........................................................................................269

Annex I g: Summary of trial information – Grapes .........................................................................................272

Annex I h: Summary of trial information – Strawberry....................................................................................275

Annex I i: Summary of trial information – Onion.............................................................................................278

Annex I j: Summary of trial information – tomato ...........................................................................................281

Annex I k: Summary of trial information – pepper ..........................................................................................284

Annex I l: Summary of trial information – cucumber ......................................................................................288

Annex I m: Summary of trial information – melon ..........................................................................................291

Annex I n: Summary of trial information – flowering brassica ........................................................................297

Annex I o: Summary of trial information – Brussels sprouts ..........................................................................300

Annex I p: Summary of trial information – round cabbage, red cabbage and savoy cabbage ......................302

Annex I q: Summary of trial information – leafy brassica ...............................................................................305

Annex I r: Summary of trial information – kohlrabi .........................................................................................307

Annex I s: Summary of trial information – green beans .................................................................................309

Annex I t: Summary of trial information – hop ................................................................................................311

Annex II – Summary of trials conducted in NAFTA Regions..........................................................................313
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex III: Import tolerances (evaluation document of UK):............................................................................336
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.1 Metabolism, distribution and expression of residues in plants (Annex IIA 6.2; Annex 

IIIA, 8.1) 

B.7.1.1 Metabolism in cotton 

Reference: Metabolism of [azaspirodecenyl-3-14C]BYI 08330 in cotton after spray 

application 

Author(s), year: Spiegel, K. 2006 

Report/Doc. number: Report No.: MEF-236/04, 

Edition Number: M-269105-01-2 

Guideline(s): PMRA Regulatory Directive 98-02; DACO 6.3; EPA OPTTS 860.1300 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Material and methods: 

The metabolism of spirotetramat was investigated in cotton (gin trash, lint & undelinted seeds) following two 

spray applications of [azaspirodecenyl-3-14C]-spirotetramat, formulated as a suspension concentrate (240 

SC), at a total rate of 264 g a.i./ha/season (0.23 lbs. a.i./A)). The first application was made at an early 

growth stage (BBCH 15) at a rate of 91.7 g a.i./ha, and the second at growth stage 85 (134 days interval) at 

a rate of 172.3 g a.i./ha. One immature cotton plant sample was collected at 19 days after the first 

application. Cotton gin trash, lint and undelinted seed samples were harvested 39 days after the last

treatment. 

Intermediate samples, gin trash, lint and undelinted seed underwent homogenization and successive 

extractions with acetonitrile (ACN)/water (lint underwent a final extraction with ACN only). Aliquots of 

combined extracts were subjected to analysis by liquid scintillation counting (LSC). The remaining solids 

were air dried, and aliquots were combusted and measured for radioactivity using LSC. TRR values were

calculated by combining the radioactivity detected in the extracts and solids. Further analysis was 

undertaken in which the ACN/water extracts were partitioned with dichloromethane (DCM) to yield an 

organic and aqueous phase. Each phase was measured for radioactivity using LSC and analyzed by highperformance liquid chromatography (HPLC). Fractions containing the purified metabolites were concentrated 

and analyzed by HPLC-mass spectrometry (MS)/MS and/or Fourier Transform (FT)-MS. Resulting 

conjugates were identified by HPLC and/or thin-layer chromatography (TLC) analysis. The conjugates of the 

intermediate sample were cleaved by acidic treatment and enzymatic hydrolysis with ß-glucosidase. 

Findings: 

The total radioactive residue (TRR) was 2.381 mg-equiv./kg in the immature plant sample, 1.641 mgequiv./kg in gin trash, 1.078 mg-equiv./kg in lint, and 0.119 mg-equiv./kg in undelinted seed. Parent 

compound, spirotetramat, was the major residue (46.95% of the TRR, 1.117 mg-equiv./kg) identified in the 

immature cotton plant. 

Also identified were 13 minor metabolites ranging from 0.18% to 9.76% of the TRR (0.004-0.232 mgequiv./kg). The major residues identified in cotton gin trash were BYI 08330-ketohydroxy (29.7% of the TRR; 

0.478 mg-equiv./kg), spirotetramat (19.8% of the TRR; 0.319 mg-equiv./kg), and BYI 08330-enol (12.1% of 

the TRR; 0.196 mg-equiv./kg). The major residues identified in cotton lint were spirotetramat (32.3% of the 

TRR; 0.348 mg-equiv./kg), BYI 08330-mandelic acid amide (11.9% of the TRR; 0.128 mg-equiv./kg), and 

BYI 08330-ketohydroxy (10.5% of the TRR; 0.113 mg-equiv./kg). The major residue found in the cotton 

undelinted seeds was BYI 08330-enol (39.8% of the TRR; 0.047 mg-equiv./kg), while BYI 08330-
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

ketohydroxy represented 9.04% of the TRR (0.011 mg-equiv./kg). Ten metabolites representing 0.6-4.4% of 

the TRR (0.003-0.064 mg-equiv./kg) were also identified in the gin trash, lint and undelinted seeds. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.1.1-1: Summary of Characterization and Identification of Radioactive Residues in Plant Matrices Following Application of Radiolabeled Spirotetramat at 264 g a.i./ha. 

Intermediate Gin Trash Lint Undelinted Seed 

TRR=2.381 

mg-equiv./kg 

TRR=1.614 

mg-equiv./kg 

TRR=1.078 

mg-equiv./kg 

TRR=0.119 

mg-equiv./kg 

TRR=2.381 

mg-equiv./kg 

TRR=1.614 

mg-equiv./kg 

TRR=1.078 

mg-equiv./kg 

TRR=0.119 

mg-equiv./kg Metabolite Fraction 

%TRR mg-equiv./kg %TRR mg-equiv./kg %TRR mg-equiv./kg %TRR mg-equiv./kg 

-enol-Glc 4.65 0.111 - - - - - - -mandelic acid - - - - 0.89 0.010 - - -mandelic acid amide 0.36 0.009 1.65 0.027 11.87 0.128 1.30 0.002 -desmethyl-enol-Glc 3.82 0.091 1.75 0.028 - - 3.46 0.004 -desmethyl-ketohydroxy-Glc (I1) 

3.45 0.082 1.42 0.023 0.14 0.001 - - 

-desmethyl-ketohydroxy-Glc (I2) 

6.31 0.150 2.32 0.038 - - - - 

-hydroxymorpholinedion 0.61 0.014 0.64 0.01 - - - --desmethyl-ketohydroxy 0.18 0.004 0.56 0.009 - - - - -MA-amide 0.58 0.014 1.54 0.025 4.12 0.044 - - -enol 1.98 0.047 12.09 0.196 9.46 0.101 39.811 0.0471 -ketohydroxy 5.40 0.129 29.65 0.478 10.45 0.113 9.04 0.011 BYI 08330-olefine(I1) 0.54 0.013 1.76 0.028 4.08 0.044 - - BYI 08330-olefine(I2) 0.43 0.010 2.04 0.033 4.35 0.047 - - Spirotetramat (a.i.) 46.94 1.117 19.78 0.319 32.32 0.348 0.42 <0.001 Total Identified (conventional extraction methods) 

75.3 1.791 79.2 1.278 77.7 0.837 22.9 0.027 

Total Identified after exhaustive extraction methods 

- - - - - - 34.6 0.041 

Total Identified Overall 75.3 1.791 79.2 1.278 77.7 0.837 57.5 0.068 Total Characterized 8.8 0.210 9.4 0.152 14.8 0.160 13.9 0.017 Not Analyzed - - - - - - 9.1 0.011 Total Extractable 84.1 2.002 88.6 1.430 92.5 0.997 80.5 0.096 Total Bound1 15.9 0.379 11.4 0.184 7.5 0.080 9.6 0.011 Precipitate - - - - - - 9.9 0.012 Total/Accountability 100.0 2.381 100.0 1.614 100.0 1.078 100 0.119 1 Residues remaining after exhaustive extractions. 2 Accountability = (Total extractable + Total unextractable)/(TRR from combustion analysis) * 100. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

# Divides into 4 different phases obtained during partitioning and clean-up, none of the phase exceeded 0.005 mg-equiv./kg; the compounds in the phases are characterized 

by their partitioning behaviour and/or their retention behaviour on an RP18 column. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Conclusion: 

The major metabolic step for spirotetramat in cotton involved the hydrolysis of the ethyl carbonate group to 

form BYI 08330-enol. Oxidation of the pyrroline moiety of BYI 08330-enol led to the formation of BYI 08330-

ketohydroxy. Cleavage of the pyrroline ring of BYI 08330-ketohydroxy followed by decarboxylation and 

hydrolysis yielded BYI 08330-MA-amide, BYI 08330-olefin, BYI 08330-mandelic acid amide, and BYI 08330-

mandelic acid. Demethylation of the cyclohexyl methoxy group of BYI 08330-enol and BYI 08330-

ketohydroxy and conjugation led to the formation of BYI 08330-desmethyl-ketohydroxy and the glucoside 

and BYI 08330-desmethyl-enol-glucoside. Other minor metabolic reactions involved ring closure of BYI 

08330-MA-amide to form a morpholine ring and conjugation of BYI 08330-enol with glucose. 

Comments (RMS):

None. 

B.7.1.2 Metabolism in lettuce 

Reference: Metabolism of [azaspirodecenyl-3-14C]BYI08330 in lettuce 

Author(s), year: Haas, M., Diederich, B. 2004. 

Report/Doc. number: Report No.: MEF-049/04, 

Edition Number: M-242667-01-2 

Guideline(s): PMRA Regulatory Directive 98-02; DACO 6.3; EPA OPTTS 860.1300 

GLP: Yes 

Deviations: No 

Validity: Yes 

Material and methods: 

The metabolism of spirotetramat was investigated in head lettuce following two spray applications of 

[azaspirodecenyl-3-14C]-spirotetramat, formulated as an oil-dispersion formula (100 OD), at a total rate of 

167 g a.i./ha (0.15 lbs a.i./A). The two applications were made at a 14-day retreatment interval. Treated 

lettuce was harvested at maturity 7 days after the last treatment. 

Lettuce plants were harvested by cutting directly above the soil. Heads were weighed and cut into smaller 

pieces using garden secateurs and homogenized in liquid nitrogen. Homogenized sample material was 

separated into aliquots and stored at -20oC. Immediately following harvest, a first extraction was performed. 

Aliquots of homogenized lettuce were successively extracted with ACN/water (80/20, v/v). After each 

extraction, the suspension was centrifuged. Extracts were measured for radioactivity by liquid scintillation 

counting (LSC), after which they were combined and concentrated. The remaining lettuce solids were airdried and aliquots were combusted and radioactivity was measured by LSC. 

TRRs were calculated as the sum of the three extracts and the solids. Further analysis of extracts was 

performed by combining and concentrating the ACN/water extracts and partitioning them successively with 

dichloromethane (DCM), resulting in an organic and an aqueous phase. The phases were measured for 

radioactivity via LSC and analyzed by high-performance liquid chromatography (HPLC). An aliquot of the

remaining solids was exhaustively extracted with ACN/water (1:1) for 30 minutes at 120oC using a 

microwave MARSX (CEM method BYI 083304). The resulting extract was filtered, measured for 

radioactivity, concentrated and analyzed by HPLC. 

Five months after harvest, a larger aliquot of the homogenized lettuce was extracted as described above. 

Isolation of the major compound present in the aqueous phase was achieved by solid-phase extraction 

(SPE) clean-up using a Mega Bond Elut C18 cartridge, and HPLC using methods BD1103A4 to BD1103A6. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The purified metabolite was concentrated and used for structure elucidation by HPLC/mass spectrometry 

(MS)/MS and nuclear-magnetic resonance (NMR) spectroscopy. 

Aliquots of the aqueous remainder and the aqueous phase meant for hydrolysis were transferred into 

reaction vials and brought to the respective pH with base or acid. Prior to analyses, the hydrolyzed samples 

were neutralized, centrifuged, concentrated and diluted with water. Where possible, samples were directly 

analyzed with HPLC. These procedures were used to release glucose conjugates. 

Findings: 

Greater than 95% of the total radioactive residue (TRR) in lettuce was extracted with acetonitrile 

(ACN)/water. The TRR was 3.13 mg-equiv./kg, calculated by summing extracts and post extraction solids. 

Over 91% of the extracted radioactivity was identified. Unchanged parent compound spirotetramat was the 

major residue identified (55.9% of the TRR; 1.75 mg-equiv./kg), followed by BYI 08330-enol (17.8% of the 

TRR; 0.56 mg-equiv./kg), BYI 08330-enol-glucoside (11.4% of the TRR; 0.36 mg-equiv./kg), and BYI 08330-

ketohydroxy (6.2% of the TRR; 0.2 mg-equiv./kg). 

Table B.7.1.2-1: Summary of Characterization and Identification of Radioactive Residues in Plant 

Matrices Following Application of Radiolabeled Spirotetramat at 167 g a.i./ha/season 

Lettuce Heads 

Compound TRR =3.13 mg-equiv./kg 

% TRR mg-equiv./kg 

Spirotetramat 55.9 1.75 

BYI 08330-ketohydroxy 6.2 0.20 

BYI 08330-enol 17.8 0.56 

BYI 08330-enol-glucoside 11.4 0.36 

Total identified 91.4 2.87 

Total characterized 7.3 0.22 

Total extractable 98.7 3.09 

Unextractable (PES)1 1.3 0.04 

Accountability2 100.00 3.13 

1 Residues remaining after extractions. 

2 Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis).

Conclusion:

The metabolism of spirotetramat in lettuce involved the hydrolytic cleavage of the ester bond of the parent 

compound to form BYI 08330-enol and subsequent conjugation to BYI 08330-enol-glucoside. Further 

hydroxylation in the tetramic acid moiety resulted in BYI 08330-ketohydroxy.

B.7.1.3 Metabolism in potato 

Reference: Metabolism of [azaspirodecenyl-3-14C]BYI 08330 in potatoes 

Author(s), year: Sur, R., 2005 

Report/Doc. number: Report No.: MEF-05/320, 

Edition Number: M-267707-01-2 

Guideline(s): PMRA Regulatory Directive 98-02; DACO 6.3; EPA OPTTS 860.1300 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Material and methods: 

The metabolism of spirotetramat was investigated in potatoes (tuber & tops) following three spray 

applications of [azaspirodecenyl-3-14C]-spirotetramat, formulated as an oil dispersion (100 OD), at a total 

rate of 308 g a.i./ha (0.275 lbs. a.i./A). The applications were made at a 21-day re-treatment interval (RTI). 

Potato samples were harvested 14 days after the last treatment. 

Aliquots of tubers and tops were extracted three times with ACN/water (4:1, v/v) and once with ACN. 

Extracts were filtered and the solids were washed with small amounts of ACN. Corresponding extracts were 

combined for determination of radioactivity by LSC. Undissolved solids were air dried yielding solids

samples for radioactivity determination via combustion and LSC. The results of the combined extracts and 

the solids were used in the calculation of the TRR. Further analysis was performed in which the combined 

extracts of tubers and tops were partitioned three times with dichloromethane (DCM), yielding an organic 

and an aqueous phase. Organic and aqueous phases were analyzed by high-performance liquid 

chromatography (HPLC) for quantitation of parent compound and metabolites. A second aliquot of tuber 

was extracted and partitioned with DCM for the isolation of metabolites from the aqueous phase. TLC was 

employed for the sub-quantitation of metabolites in fractions collected from HPLC and for the identification of 

metabolites by co-chromatography with reference compounds. 

Solids resulting from the first extraction of tubers were further extracted by treatment with diastase. Aliquots 

of solids were incubated in a round bottomed flask with 22 mL of a diastase containing solution. The mixture 

was stirred for 6 days at room temperature. Afterwards, it was centrifuged and the supernatant was 

decanted. The solid residue was extracted again in the same manner. Both supernatants were combined 

and aliquots were analyzed by HPLC and LSC. Undissolved residues were air dried at room temperature 

resulting in a secondary set of solids for radioactive analysis via combustion and LSC. 

The enzyme cellulose (1.7 U/mg, type “Onozuka R-10” from the fungus Trichoderma viride) was used to 

selectively cleave the O-1,4 glycoside bond of BYI 08330-desmethyl-enol-glycoside and BYI 08330-

ketohydroxy-alcohol-glycoside to identify the corresponding aglycons. Additionally, the aqueous phase of 

the tubers was also treated with cellulose. For each test, solutions of cellulose were prepared and tested for 

activity using p-nitrophenyl-ß-D-glucopyranoside. Sodium azide at 0.02% was added to minimize microbial 

proliferation. Aliquots of the isolated conjugates or of the aqueous phase were evaporated to dryness and 

reconstituted with the cellulose containing solution or only with buffer (control sample). 

Findings: 

Approximately 80% of the total radioactive residue (TRR) in tuber, and 96% of the TRR in tops were 

extracted with acetonitrile (ACN)/water. Enzymatic treatment of the extracted tuber released approximately 

14% of the TRR. The TRR in tuber and tops was 0.255 mg-equiv./kg and 11.057 mg-equiv./kg, respectively, 

calculated by summing extracts and post extraction solids. 

Parent spirotetramat was not identified in potato tuber. The predominant metabolite identified was BYI

08330-enol (65.8% of the TRR; 0.168 mg-equiv./kg), followed by BYI 08330-ketohydroxy (6.8% of the TRR;

0.018 mg-equiv./kg) and BYI 08330-desmethyl-enol (6.7% of the TRR; 0.018 mg-equiv./kg) and several 

other minor metabolites (≤2.5 % of the TRR; 0.006 mg-equiv./kg). In potato tops, spirotetramat and BYI

08330-ketohydroxy were the major residues identified, represented 49.4% (5.5 mg-equiv./kg) and 24.8% of 

the TRR (2.7 mg-equiv./kg), respectively. BYI 08330-enol (7.8% of the TRR; 0.87 mg-equiv./kg) and several 

other minor metabolites (≤3.6% of the TRR) were also identified. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.1.3-1: Summary of Characterization and Identification of Radioactive Residues in Plant 

Matrices Following Application of Radiolabeled Spirotetramat at 308 g a.i./ha/season. 

Tubers Tops 

Compound TRR = 0.255 mg-equiv./kg TRR = 11.057 mg-equiv./kg 

% TRR mg-equiv./kg % TRR mg-equiv./kg 

Spirotetramat ND ND 49.4 5.455 

BYI 08330-enol 65.8 0.168 7.8 0.870 

BYI 08330-enol-glucoside 2.5 0.006 3.6 0.395 

BYI 08330-desmethyl-enol 6.7 0.018 1.1 0.119 

BYI 08330-desmethyl-enol-glycoside 1.5 0.004 0.5 0.055 

BYI 08330-enol-alcohol 0.6 0.002 0.2 0.020 

BYI 08330-ketohydroxy 6.8 0.018 24.8 2.745 

BYI 08330-ketohydroxy-alcohol 0.5 0.001 ND ND 

BYI 08330-ketohydroxy-alcoholglycoside 0.5 0.001 ND ND 

BYI 08330-dihydroxy 0.2 0.001 ND ND 

Total identified 85.1 0.217 87.4 9.659 

Total characterized 9.4 0.024 8.7 0.957 

Total extractable 94.5 0.241 96.0 10.616 

Unextractable (PES)1 5.5 0.014 4.0 0.442 

Accountability2 100 0.255 100 11.058 

1 Residues remaining after extractions. 

2 Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis). 

ND Not detected 

Conclusion: 

The metabolism of spirotetramat in potatoes mainly involved the hydrolysis of the parent compound to BYI 

08330-enol, followed by the oxidation of BYI 08330-enol to BYI 08330-ketohydroxy. Further conjugation of 

BYI 08330-enol to BYI 08330-enol glucoside occurred with subsequent O-Demethylation of BYI 08330-enol 

to BYI 08330 desmethyl-enol. 

B.7.1.4 Metabolism in apple 

Reference: Metabolism of (azaspirodecenyl-3-14C)BYI08330 in apple after spray 

application 

Author(s), year: Haas, M.; Henk, F., 2005 

Report/Doc. number: Report No.: MEF-028/04, 

Edition Number: M-244827-01-3 

Guideline(s): PMRA Regulatory Directive 98-02; DACO 6.3; EPA OPTTS 860.1300 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Material and methods: 

The metabolism of spirotetramat was investigated in apple (fruits & leaves) following two spray applications 

of [azaspirodecenyl-3-14C]-spirotetramat, formulated as an oil-dispersion formula (100 OD), at a total rate of 

1100 g a.i./ha (0.982 lb a.i./A). The first application was at a growth stage 69 of the current BBCH code and 

the second application was 20 days later at growth stage 71, 2 months (63 days) before harvest. A 

supplementary apple cell culture study was also submitted. This study was conducted to ascertain the 
- 13 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

metabolic fate of spirotetramat in isolated plant cells. As well, from this study, selected metabolites were 

obtained in larger amounts to be used as radioactive reference compounds in guideline nature of the residue 

studies. 

Apples were surface washed using dichloromethane (DCM). Aliquots of wash solution were concentrated 

and used for radioactive measurements using high-performance liquid chromatography (HPLC) analysis. 

Surface washed apples were homogenized and stored frozen until extraction. Aliquots of homogenate were 

extracted with ACN:water (80/20, v/v). After each extraction step, suspensions were filtered and filters were 

washed with ACN. Extracts were measured for radioactivity by liquid-scintillation counting (LSC), combined 

and concentrated. The solids were lyophilized and aliquots of the homogenized solids were combusted and 

measured for radioactivity by LSC. Structure elucidation was achieved by HPLC/mass spectrometry 

(MS)/MS and nuclear-magnetic resonance (NMR) spectroscopy. 

Apple leaves were homogenized with liquid nitrogen and extracted three times with ACN/water (80/20, v/v). 

At each step the leaves were macerated and filtered, after which the radioactivity of each extract was

determined separately prior to being combined. Leaf solids were air-dried, subjected to combustion and 

measured for radioactivity by LSC. 

From the apple cell culture study, samples were taken seven days after application of radiolabelled 

spirotetramat. Cells were separated from the nutrient medium by filtration. The cells were washed 

intensively with water to remove soluble radioactivity from the cell surfaces. The wash solution was 

combined with the nutrient medium. Liquid samples were concentrated at 35oC and re-dissolved in an 

appropriate solvent for further investigation. 

 Findings: 

Total radioactive residue (TRR) amounted to 0.61 mg-equiv./kg (apple) and 36.63 mg-equiv./kg (apple 

leaves). Approximately 49% of the TRR (0.3 mg-equiv./kg) in apple was surface residues washed with 

dichloromethane. Washed apple extracted with acetonitrile (ACN)/water yielded 49.5% of the TRR leaving 

only 2.1% of the TRR (0.01 mg-equiv./kg) as unextractable residues. Unchanged parent spirotetramat was 

the only residue detected in the surface wash. The predominant residue found in the extract was BYI 08330-

mono-hydroxy followed by BYI 08330-ketohydroxy, BYI 08330-di-hydroxy, BYI 08330-desmethylketohydroxy, BYI 08330-enol, and the respective glycosides thereof. As in apple fruits, the major residue in 

apple leaves was the unchanged spirotetramat (72% of the TRR). Other residues detected were BYI 08330-

ketohydroxy, BYI 08330-enol, and glycoside isomers of BYI 08330-desmethyl-ketohydroxy. A BYI 08330-

ketohydroxy-formiate-glycoside was also detected. Approximately 44% of the recovered radioactivity was

found in the cells and ca. 56% in the nutrient medium. The major part of the radioactivity present in the 

extracts of cells and nutrient medium partitioned into the organic phase (ethyl acetate). The formation of 

bound residues observed was minimal (<1% of the recovered radioactivity). 

Table B.7.1.4-1: Summary of Characterization and Identification of Radioactive Residues in Apple 

Matrices Following Target Application of Radiolabeled Spirotetramat at 1152 g a.i./ha. 

Apple Fruit Apple Leaves 

Compound TRR = 0.61 mg-equiv./kg TRR = 36.63 mg-equiv./kg 

% TRR mg-equiv./kg % TRR mg-equiv./kg 

Spirotetramat (parent) 51.3 0.32 72.0 26.37 

BYI 08330-ketohydroxy 7.7 0.05 3.0 1.09 

BYI 08330-enol 2.1 0.01 11.6 4.26 

BYI 08330-mono-hydroxy 15.6 0.10 ND ND 

BYI 08330-desmethyl-ketohydroxy 3.8 0.02 ND ND 

BYI 08330-di-hydroxy 4.4 0.03 ND ND 
- 14 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Apple Fruit Apple Leaves 

Compound TRR = 0.61 mg-equiv./kg TRR = 36.63 mg-equiv./kg 

% TRR mg-equiv./kg % TRR mg-equiv./kg 

BYI 08330-desmethyl-ketohydroxyglucoside (isomers), in leaves also +BYI 

08330-ketohydroxy-formiate-glycoside 

1.9 0.01 8.0 2.92 

BYI 08330-enol-glycoside 5.1 0.03 ND ND 

Total identified 91.9 0.57 94.6 34.65 

Total characterized 6.0 0.04 ND ND 

Total extractable 98.0 0.60 94.6 34.65 

Unextractable (PES)1 2.1 0.01 5.4 1.97 

Accountability2 100.0 0.61 100.0 36.63 

1 Residues remaining after extractions. 

2 Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis). 

ND Not detected 

Conclusion: 

Major reactions involved in the degradation of the parent compound were hydrolysis of the side chain ester 

bond resulting in the BYI 08330-enol. A second hydroxylation detected in the azaspiro moiety of this BYI 

08330-enol gave the BYI 08330-keto-hydroxy. Demethylation of BYI 08330-enol resulted in the 

corresponding BYI 08330-4-hydroxyenol and further hydroxylation correspondingly in the BYI 08330-

hydroxy-keto-hydroxy metabolite. All metabolites were further conjugated to give mono and bis-glycosides. 

In the supplemental study, the degradation of spirotetramat was investigated in heterotrophic apple cell 

suspension cultures to ascertain the metabolic fate of spirotetramat in isolated plant cells. Spirotetramat was 

rapidly degraded by the apple cells to at least 14 compounds. 

B.7.1.5 Overall conclusion on the metabolic fate on crops 

The submitted metabolism data for apple, lettuce, cotton and potato are adequate to elucidate the nature of 

the residue in plants. Major metabolic reaction involved the hydrolytic cleavage of the carbonate ester 

parent bond of the parent compound to form BYI 08330-enol. Further reduction of the double bond in the 

teramic acid moiety of BYI 08330-enol occurred to form the BYI 08330-mono-hydroxy metabolite. 

Hydroxylation in the tetramic acid moiety resulted in BYI 08330-ketohydroxy. Demethylation of the methoxy 

group of the cyclohexyl ring resulted via a proposed intermediate (BYI 08330-desmethyl-enol) in BYI 08330-

desmethyl-ketohydroxy (after the corresponding hydroxylation). Oxidation of the methoxy group resulted in 

BYI 08330-ketohydroxy-formiate. Partly, metabolites bearing a hydroxy group were conjugated with glucose. 

In cotton, cleavage of the pyrrolidine ring of BYI08330-ketohydroxy followed by decarboxylation and further 

cleavage reactions led to the formation of BYI08330-MA-amide, BYI08330-olefin, BYI08330-mandelic acid 

amide, and BYI08330-mandelic acid. Ring closure of the initial cleavage product formed BYI08330-

hydroxymorpholinedione. 
- 15 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Figure B.7.1.5-1: 

Proposed Metabolic Scheme in Plants

NH

O

CH3

CH3

H

OH

O

O

HO

HO

HO

HO

BYI 08330-

desmethyl-enol-Glc

(C, P, Sc)

CH3

CH3

NH

O

H

O

O

O

HO

HO

HO

HO

CH3

BYI 08330-

enol-Glc (C, P, A, Sc)

NH

O

CH3

CH3

H

O

CH3

O

O

H3C

O

BYI 08330 (parent)

e

*

NH

O

CH3

CH3

H

O

CH3

HO

e

BYI 08330-enol

(C, L, P, A, Sc)

NH

O

CH3

CH3

H

OH

HO

e

BYI 08330-

desmethyl-enol

(C, P, A, Sc)

CH3

CH3

NH

O

HO

H

OH

OH

BYI 08330-

dihydroxy (P, A)

CH3

CH3

NH

O

O

H

O

OH

CH3

BYI 08330-

ketohydroxy (C, L, P, A, Sc)

e

BYI 08330-

ketohydroxyformiate (A)

CH3

CH3

NH

O

O

H

OH

OH

BYI 08330-

desmethylketohydroxy (C, A, Sc)

e

CH3

CH3

NH

O

O

H

OH

OH

O

HO

OH

OH

OH

OH

+

-H2O

BYI 08330-

desmethylketohydroxy-Glc (isomers)

C, A, Sc)

BYI 08330-

desmethylketohydroxy-bis-glycoside

(Sc)

NH

O

CH3

CH2OH

HO

H

O

CH3

BYI 08330-

enol-alcohol (P)

CH3

CH3

NH

HO O

O

OH

H

O

CH3

BYI 08330-

MA-amide (C)

CH3

CH3

N

H

H

O

OH

OCH3

CH3

CH3

N

H

OH

O

OCH3

BYI 08330-

olefine (C)

CH3

OH

OH

CH3

O

BYI 08330-

mandelic acid (C)

CH3

NH2

OH

CH3

O

BYI 08330-

mandelic acid amide (C)

CH3

CH2OH

NH

O

O

OH

H

O

CH3

BYI 08330-

ketohydroxy-alcohol (P)

NH

O

OH

CH3

CH3

O

O

H

O

CH3

BYI 08330-

hydroxymorpholinedion (C)

CH3

CH2OH

NH

O

O

OH

H

O

CH3

BYI 08330-

ketohydroxy-alcoholglycoside (P)

+ C6H12O6

 - H2O

CH3

CH3

NH

O

HO

H

O

CH3

e

BYI 08330-

mono-hydroxy (A)

BYI 08330-

ketohydroxyformiate-glycoside (A)

+ hexose,

-H2O

CH3

CH3

NH

O

O

OH

H

O

C

H

O e
- 16 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.2 Metabolism, distribution and expression of residues in livestock (Annex IIA 6.2; Annex 

IIIA, 8.1) 

B.7.2.1 Metabolism in lactating goat 

Reference: [Azaspirodecenyl-3-14C]BYI 08330: Absorption, distribution, excretion, and 

metabolism in the lactating goat 

Author(s), year: Koester, J., Klempner, A., 2006 

Report/Doc. number: Report No.: MEF-05/293, 

Edition Number: M-269256-01-2 

Guideline(s): PMRA Directive 98-02; DACO 6.2/EPA OPPTS 860.1300 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Material and methods: 

The nature of the residue in milk and foodstuffs originating from ruminants was investigated with a lactating 

goat following 4 daily oral administrations of [azaspirodecenyl-3-14C]-spirotetramat at a mean dose rate of 

2.22 mg a.i./kg bw/day (73.03 mg/kg in feed) given by gavage. Milk samples were collected twice daily, 

urine and feces were collected once daily. The treated goat was sacrificed ca. 24 hrs after the last dosage, 

and muscle (round, flank, loin), fat (perirenal, omental subcutaneous), liver, and kidneys were collected. 

Liver, kidney, fat and muscle samples were homogenized 4-5 times in a half-frozen state using a mincing 

machine. Aliquots of the resulting tissue pulp were weighed, freeze-dried, weighed again and homogenized 

prior to radioactivity measurement by combustion/LSC. Perirenal and omental fat also underwent the 

determination of total radioactivity by LSC after solubilization of tissues with Beckman Tissue Solubiliser 

(BTS)-450. The gall bladder was dissected from the liver and punctured for the collection of bile. 

Samples were extracted 3-4 times with acetonitrile (ACN): water. Extracts were combined and defatted by 

reversed-phase solid-phase extraction (SPE). Flow-through fraction and rinse solution were combined and 

concentrated. In the case of fat and kidney, the concentrates were directly analyzed by high-performance 

liquid chromatography (HPLC). All other concentrated aqueous extracts were further purified by partition 

and SPE clean-up procedures. In the case of liver, two final extracts were obtained for each sample which 

were analyzed separately by HPLC. TLC co-chromatography was used for confirmation of metabolites in 

isolated HPLC fractions. 

MS was used to confirm the identity of the delivered radiolabelled test item and of metabolites isolated from 

urine. LC- nuclear-magnetic resonance (NMR)-MS spectroscopy was also performed on some extracts. 

Findings: 

Approximately 90% of the administrated dose (AD) was eliminated via urine (78.4%), feces (11.6%), milk

(0.014%), and edible organs/tissues (0.061%). The highest total radioactive residue (TRR) was observed in 

kidney (0.184 mg-equiv./kg) and liver (0.05 mg-equiv./kg). Significantly lower residues were detected in the 

muscle: round muscle (0.011 mg-equiv./kg), flank muscle (0.009 mg-equiv./kg), and loin muscle (0.008 mgequiv./kg); and fat: subcutaneous fat (0.008 mg-equiv./kg), omental fat (0.003 mg-equiv./kg), and perirenal 

fat (0.003 mg-equiv./kg). The TRR in milk samples was in the range of 0.0038-0.0261 mg-equiv./kg within 

the observation period of 96 hours. 
- 17 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.2.1-1: Total Radioactive Residue (TRR) in Milk 

[Azaspirodecenyl-3-14C] Spirotetramat 

Matrix 

Collection Timing 

(hrs after 1st

dose) % AD+

 mg-equiv./kg 

0 1st dose -- -- 

8 0.0019 0.0113 

24 2nd

dose 

0.0009 0.0038 

32 0.0024 0.0150 

48 3rd dose 0.0013 0.0053 

56 0.0032 0.0261 

72 4th dose 0.0012 0.0061 

80 0.0022 0.0140 

Milk 

96 0.0009 0.0039 

The parent compound was not detected in samples of milk, muscle, fat, liver and kidney. The major 

metabolites detected were BYI 08330-enol (33.7-78.4% of the TRR) and BYI 08330-enol-glucuronide (14.2-

37.4% of the TRR). Three other minor metabolites (BYI 08330-ketohydroxy, BYI 08330-desmethyl-enol, and 

BYI 08330-mono-hydroxy) were found each at less than 10% of the TRR. 

Table B.7.2.1-2: Summary of Characterization/Identification of Radioactive Residues in Livestock 

Matrices Following Application of 14C-Spirotetramat at 2.2 mg/kg bw for 4 consecutive days. 

Muscle Fat Liver Kidney Milk (day 4 pool) 

TRRs = 0.011 mgequiv./kg TRRs = 0.003 

mg-equiv./kg 

TRRs = 0.050 mgequiv./kg TRRs = 0.184 

mg-equiv./kg 

TRRs = 0.008 

mg-equiv./kg Compound 

% TRR 

mgequiv./

kg 

% 

TRR 

mgequi

v./kg 

% TRR 

mgequiv./

kg 

% 

TRR 

mgequi

v./kg 

%TRR 

mgequiv.

/kg 

Parent 

Spirotetramat 

-- -- -- -- -- -- -- -- -- -- 

BYI 08330-enol-GA -- -- 19.4 0.00

1 

37.4 0.019 14.2 0.02

6 

23.9 0.002 

BYI 08330-

desmethyl-enol 

7.4 0.001 -- -- 6.6 0.003 4.4 0.00

8 

7.9 0.001 

BYI 08330-monohydroxy -- -- -- -- 4.1 0.002 -- -- 2.3 <0.00

1 

BYI 08330-enol 72.4 0.008 59.9 0.00

2 

33.7 0.017 78.4 0.14

4 

48.8 0.004 

BYI 08330-

ketohydroxy 

9.7 0.001 -- -- 2.7 0.001 2.1 0.00

4 

2.3 <0.00

1 

Unknown -- -- -- -- 10.7 0.005 0.9 0.00

2 

14.9 0.001 

Total identified 89.6 0.010 79.3 0.00

2 

84.3 0.042 99.1 0.18

2 

85.1 0.007 

Total characterized -- -- -- -- 10.7 0.005 0.9 0.00

2 

14.9 0.001 

Total extractable 89.6 0.10 79.3 0.00

2 

95.0 0.047 100 0.18

4 

100 0.008 

Unextractable -

PES1

-- -- 20.7 0.00

1 

4.7 0.002 -- -- -- -- 

Accountability2 100 0.011 100 0.00

3 

100 0.05 100 0.18

4 

100 0.008 

1 Residues remaining after extractions. 

2 Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis). 
- 18 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Conclusion: 

The metabolism of spirotetramat in ruminants involved cleavage of the ester group to the primary metabolite 

BYI 08330-enol followed by conjugation of the enol hydroxy group with glucuronic acid to BYI 08330-enolGA. Oxidation of the azaspirodecenyl moiety to BYI 08330-ketohydroxy and demethylation of the methoxy

group to BYI 08330-desmethyl-enol were minor metabolic reactions as well as reduction of the 

azaspirodecenyl moiety to BYI 08330-monohydroxy. 

B.7.2.2 Metabolism in laying hen 

Reference: Metabolism of [Azaspirodecenyl-3-14C] BYI 08330 in the Laying Hen 

Author(s), year: Koester, J., Klempner, A., 2006 

Report/Doc. number: Report No.: MEF-05/273, 

Edition Number: M-268574-01-2 

Guideline(s): PMRA Directive 98-02; DACO 6.2/EPA OPPTS 860.1300 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Materials and method: 

The nature of the residue in eggs and tissues was investigated with 6 laying hens dosed orally once daily by 

gavage with [azaspirodecenyl-3-14C]spirotetramat at a rate of 1.01 mg a.i./kg bw/day (12.86 mg/kg in feed) 

for 14 days. Eggs and excreta were collected daily. The treated hens were sacrificed ca. 24 hrs after the 

last dosage. Liver, kidney, muscle (leg, breast), fat (subcutaneous), skin (without fat) were collected. 

Tissues (except fat) were homogenized in half-frozen state using a mincing machine. An aliquot of each 

resulting tissue pulp was weighed, freeze-dried, weighed again, homogenized and determined triply for 

radioactivity by combustion following LSC. Aliquots of subcutaneous fat and skin without fat were weighed 

and solubilized with BTS-450 and measured for radioactivity by LSC. Gall bladders were punctured for the 

collection of the bile fluid. 

Aliquot samples from egg pool, combined muscle, subcutaneous fat, liver and excreta samples were used 

for metabolite analysis. Each tissue type was extracted 3-4 times with ACN water. The extracts of each 

sample were combined and cleaned-up using reverse-phase SPE. Flow through fractions and rinse solution 

of each sample were combined and concentrated prior to HPLC analysis. 

Metabolite identification was carried out via HPLC co-chromatography with reference standards. Normalphase thin-layer chromatography (TLC) co-chromatography was applied as a second method. Individual 

peak fractions were subsequently analyzed by TLC co-chromatography together with the respective 

reference items. MS was used to confirm the identity of the delivered radiolabelled test item. LC- nuclearmagnetic resonance (NMR)-MS spectroscopy was also performed on some extracts. 

Findings: 

The majority of the radioactivity (90% of the administered dose, AD) was detected in the excreta. Only 

0.045% and 0.023% of the total AD were detected in the eggs and edible organs/tissues, respectively. The 

highest total radioactive residue (TRR) was detected in kidneys (0.039 mg-equiv./kg) and liver (0.017 mgequiv./kg), followed by fat (0.004 mg-equiv./kg), and muscle (0.003 mg-equiv./kg). The average TRR in eggs 

was 0.015 mg-equiv./kg. 
- 19 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The parent compound was not detected in any of the samples. BYI 08330-enol was the major metabolite 

detected in eggs, liver, fat and muscle (18-84% of the TRR; 0.001-0.013 mg-equiv./kg). The glucuronic acid 

conjugate BYI 08330-enol-GA was also detected in eggs (6.9% of the TRR, 0.001 mg-equiv./kg), muscle 

(4.2% of the TRR, <0.001 mg-equiv./kg) and liver (15.1% of the TRR, 0.003 mg-equiv./kg). 

Table B.7.2.2-1: Summary of Characterization and Identification of Radioactive Residues in Livestock 

Matrices Following Application of Radiolabelled Spirotetramat at 1.01mg/kg bw for 14 Consecutive 

Days. 

Muscle Fat Liver Eggs 

TRRs = 0.003 mgequiv./kg TRRs = 0.004 mgequiv./kg TRRs = 0.017 mgequiv./kg TRRs = 0.015 mgequiv./kg Compound 

% TRR 

mgequiv./k

g 

% TRR mgequiv./kg % TRR mgequiv./kg %TRR mgequiv./kg 

Spirotetramat -- -- -- -- -- -- -- -- 

BYI 08330-enol-GA 4.2 <0.001 -- -- 15.1 0.003 6.9 0.001 

Unknown 1 6.9 <0.001 -- -- 3.6 0.001 4.7 0.001 

BYI 08330-enol 64.4 0.002 18.4 0.001 50.0 0.009 83.9 0.013 

Unknown 2A -- -- 56.5 0.002 -- -- -- -- 

Total identified 68.6 0.002 18.4 0.001 65.1 0.011 90.8 0.014 

Total characterized 6.9 <0.001 56.5 0.002 3.6 0.001 4.7 0.001 

Total extractable 75.6 0.002 74.9 0.003 68.6 0.012 95.5 0.014 

Unextractable (PES)1 24.4 0.001 25.1 0.001 30.0 0.005 4.5 0.001 

Accountability2 100 0.003 100 0.004 98.6 0.017 100 0.015 

1 Residues remaining after extractions. 

2 Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis). 

A Presumably fatty acid conjugate of BYI 08330-enol or related metabolite. 

Conclusion: 

Laying hens metabolized spirotetramat intensively and no parent compound was detected in any sample. 

Spirotetramat was mainly metabolized in laying hens by: 1) Cleavage of the ester bond of the side chain 

yielding BYI 08330-enol. 2) Conjugation of BYI 08330-enol with glucuronic acid. 3) Demethylation of the 

cyclohexyl-O-methyl group to the respective alcohol and 4) hydroxylation in the pyrrolidine ring of BYI 08330-

enol resulting in BYI 08330-ketohydroxy. 

Comments (RMS):

B.7.2.3 Overall conclusion on the metabolic fate in livestock animals: 

The submitted goat and poultry metabolism data are adequate to satisfy data requirements. The 

biodegradation of spirotetramat in livestock can be characterized as cleavage of the carbonate ester group to 

the primary metabolite BYI 08330-enol followed by conjugation of the enol hydroxy group with glucuronic 

acid to BYI 08330-enol-GA. Oxidation of the azaspirodecenyl moiety to BYI 08330-ketohydroxy and 

demethylation of the methoxy group to BYI 08330-desmethyl-enol were minor metabolic reactions in 

ruminants as well as reduction of the azaspirodecenyl moiety to BYI 08330-monohydroxy. Based on the 

currently proposed uses, the residue definition for the expression of the MRL in livestock commodities is 

spirotetramat and the metabolite BYI 08330-enol. The residue definition for dietary exposure assessment in 

livestock commodities is spirotetramat and the metabolites BYI 08330-enol and BYI 08330-enol-GA. 
- 20 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Figure B.7.2.3-1: Proposed metabolic pathway of spirotetramat in livestock: 

BYI 08330 (parent)

BYI 08330-enol

BYI-08330-

ketohydroxy

BYI-08330-

desmethyl-enol

BYI 08330-

mono-hydroxy (lactating

goats only)

Congugation with

 glucuronic acid

Chemical Names and Structures of Spirotetramat and Metabolites.

Common name/code 

 Chemical name Chemical structure 

Spirotetramat (parent) cis-3-(2,5-dimethylphenyl)-8- 

methoxy-2-oxo-1-azaspiro 

[4.5]dec-3-en-4-yl ethyl 

carbonate 

BYI 08330-ketohydroxy cis-3-(2,5-dimethylphenyl)-3- 

hydroxy-8-methoxy-1- 

azaspiro [4.5]decane-2,4- 

dione 
- 21 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

BYI 08330-enol cis-3-(2,5-dimethylphenyl)-4- 

hydroxy-8-methoxy-1- 

azaspiro [4.5]dec-3-en-2-one 

BYI 08330-enol-alcohol cis-4-hydroxy-3-[5- 

(hydroxymethyl)-2- 

methylphenyl]-8- 

methoxy-1-azaspiro[4.5]dec3-en-2-one 

BYI 08330-monohydroxy 

cis-3-(2,5-dimethylphenyl)-4- 

hydroxy-8-methoxy1-azaspiro[4.5]decan-2-one 

BYI 08330-desmethylketohydroxy 

cis-3-(2,5-dimethylphenyl)- 

3,8-dihydroxy-1-azaspiro[4.5] 

decane-2,4-dione 

BYI 08330-di-hydroxy cis-3-(2,5-dimethylphenyl)- 

3,4-dihydroxy-8-methoxy-1- 

azaspiro[4.5]decan-2-one 
- 22 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

BYI 08330-desmethylketohydroxy-glucoside 

(isomers), in leaves 

also +BYI 08330-

ketohydroxy-formiateglycoside 

(Isomers) 

cis-3-(2,5-dimethylphenyl)-8- 

hydroxy-2,4-dioxo-1- 

azaspiro[4.5]dec-3-yl 

hexopyranoside 

cis-3-(2,5-dimethylphenyl)-3- 

hydroxy-2,4-dioxo-1- 

azaspiro[4.5]dec-8-yl 

hexopyranoside 

+ 

cis-3-(2,5-dimethylphenyl)-3- 

(hexopyranosyloxy)-2,4- 

dioxo-1-azaspiro [4.5]dec-8- 

yl formate 

+ 

BYI 08330-enol-Glc cis-3-(2,5-dimethylphenyl)-8- 

methoxy-2-oxo-1-azaspiro 

[4.5]dec-3-en-4-yl beta-Dglucopyranoside 

BYI 08330-enol-GA glucuronic acid conjugate of 

cis-3-(2,5-dimethylphenyl)-4- 

hydroxy-8-methoxy1-azaspiro[4.5]dec-3-en-2-one 

BYI 08330-desmethylenol 

Or 

BYI 08330-4-hydroxyenol 

cis-3-(2,5-dimethylphenyl)- 

4,8-dihydroxy-1- 

azaspiro[4.5]dec3-en-2-one 

BYI 08330-desmethylenol-Glc 

Glucoside of cis-3-(2,5-

dimethylphenyl)- 

4,8-dihydroxy-1- 

azaspiro[4.5]dec3-en-2-one 
- 23 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

BYI 08330-MA-amide Cis-1-{[(2,5-dimethylphenyl) 

(hydroxy)acetyl]amino}-4- 

methoxycyclohexanecarboxylic 

acid 

BYI 08330-mandelic 

acid amide 

2-(2,5-dimethylphenyl)-2- 

hydroxyacetamide 

BYI 08330-mandelic 

acid 

(2,5-dimethylphenyl)(hydroxy) 

acetic acid 

BYI 08330-

hydroxymorpholinedion 

Cis-3-(2,5-dimethylphenyl)-3- 

hydroxy-9-methoxy-4-oxa1-azaspiro[5.5]undecane-2,5- 

dione 

BYI 08330-olefine 2-(2,5-dimethylphenyl)-2- 

hydroxy-N-(4- 

methoxycyclohex-1-en-1- 

yl)acetamide 

or 

2-(2,5-dimethylphenyl)-2- 

hydroxy-N-(4- 

methoxycyclohexylidene) 

acetamide 

BYI 08330-

ketohydroxy-alcohol 

cis-3-hydroxy-3-[5- 

(hydroxymethyl)-2- 

methylphenyl]-8- 

methoxy-1-azaspiro 

[4.5]decane-2,4-dione 
- 24 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

BYI 08330-

ketohydroxy-alcoholglycoside 

glycoside of cis-3-hydroxy3-[5-(hydroxymethyl)-2- 

methylphenyl]-8- 

methoxy-1-azaspiro 

[4.5]decane-2,4-dione 

BYI 08330-desmethyldi-hydroxy (5s,8s)-3-(2,5-dimethylphenyl)- 

3,4,8-trihydroxy-1- 

azaspiro[4.5]decan-2-one 

BYI 08330-desmethyldihydroxy-Glc-MA glucosyl-malonic acid conjugate 

of (5s,8s)-3-(2,5- 

dimethylphenyl)-3,4,8- 

trihydroxy-1- 

azaspiro[4.5]decan-2-one 

BYI 08330-desmethylenol -alcohol (5s,8s)-4,8-dihydroxy-3-[5- 

(hydroxymethyl)-2- 

methylphenyl]- 

1-azaspiro[4.5]dec-3-en-2-one 

BYI 08330-desmethylketohydroxy-Glc-MA 

(isomer 1 & isomer 2) 

glucosyl-malonic acid conjugate 

of (5s,8s)-3-(2,5- 

dimethylphenyl)-3,8-dihydroxy1-azaspiro[4.5]decane-2,4- 

dione 
- 25 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.3 Definition of the residue (Annex IIA 6.7; Annex IIIA 8.7) 

The nature of the residue in plants, rotational crops, and livestock is adequately understood based on

acceptable metabolism studies conducted on apple, lettuce, cotton, potato, rotational crops, lactating goats, 

and laying hens. 

The residue definition for the expression of the MRL/monitoring and dietary exposure assessment for plant 

commodities is spirotetramat and the metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI08330-enolGlc, and BYI 08330-mono-hydroxy. 

The metabolism of spirotetramat in rotational crops appears to be consistent with the pathway observed in 

the plant metabolism studies. 

The following potential components of the residue definition were identified in the confined rotational crop 

study: BYI08330, BYI08330-ketohydroxy, and free and conjugated BYI08330-desmethyl-ketohydroxy, 

BYI08330-desmethyl-di-hydroxy and BYI-08330-ketohydroxy-alcohol. None of these residues were found in 

the limited rotational crop field trials at a 30-day PBI. The expected residues in rotational crops are covered 

sufficiently by the residue definition for the expression of the MRL/monitoring and risk assessment for plant 

commodities (spirotetramat and the metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI08330-enolGlc, and BYI 08330-mono-hydroxy), based on the outcome of the field trials in succeeding crops, which are 

accepted by RMS Austria as additional information. 

Based on the currently proposed uses, the residue definition for the expression of the MRL/monitoring for 

livestock commodities is spirotetramat and the metabolite BYI 08330-enol and the residue definition for the 

dietary exposure assessment for livestock commodities is spirotetramat and the metabolites BYI 08330-enol 

and BYI 08330-enol-GA. 

Comment by RMS AT:

The BYI 08330 metabolism studies in ruminants and poultry were similar in that the majority of BYI 08330 

was metabolized to BYI 08330-enol. Based on the predominant residue, the residue definition for monitoring 

in animal matrices is the parent spirotetramat (BYI 08330) and the metabolite BYI 08330-enol, expressed as 

spirotetramat (BYI 08330). 

Another major metabolite detected in ruminants (up to 24% TRR in milk; see table B.7.2.1-1) and in poultry 

(up to 7% in eggs; see table B.7.2.1-2) was the BYI 08330-enol glucuronic conjugate, therefore this 

metabolite was also included in the residue definition for risk assessment. 

Considering that the residue definitions for enforcement and for the riskassessment are different, the

conversion factors could be proposed for the riskassessment based on the metabolism studies. Livestock

feeding studies in lactating cows were performed according to the residue definition for riskassessment and 

resulted in average residues of spirotetramat equivalents less than the LOQ (0.01 mg/kg) in fat, muscle and 

liver at the 3-mg/kg dosing level (expected dietary burden: 1.9 mg a.i./kg feed calculated on dry weight 

basis). Only in kidney, residues of 0.022 mg/kg were found resulting in a tissue burden in kidney of 0.014 

mg/kg. Total spirotetramat residue in the milk samples from the 30-mg/kg feeding level were at or below the 

LOQ (0.005 mg/kg) with the exception of a maximum residue of 0.006 mg/kg in one cow on study day 10. 

Residues of parent equivalents did not concentrate in samples of skim milk or milk fat separated from whole 

milk. 

Regarding the low-to-zero residue situation in food of animal origin, it is not considered necessary to propose 

conversion factors.

B.7.4 Use pattern for European Trials 

Spirotetramat (BYI 08330) is an effective insecticide against aphids, scales, mealy bugs, psyllids, white flies 

and selected thrips. It acts mainly against immature stages and requires oral ingestion. 
- 26 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Spirotetramat is highly systemic and possesses not only xylem-, but also phloem-mobility. Once taken up by 

the plant, the active substance moves acropetal in the xylem and acropetal and basipetal in the phloem. 

After treatment, even the new shoots or the roots are protected from sap-sucking pests due to this specific 

biological property. 

Spirotetramat is intended to be used as an insecticide in agriculture on a range of crops such as citrus, pome 

and stone fruits; tree nuts, grape; strawberries, fruiting and leafy vegetables (indoor and outdoor); brassica 

vegetables, hops but also on tubers vegetables and tropical fruits such as pineapple, mangoes, bananas and 

cotton. It is also considered, to use the product on ornamentals and trees. 
- 27 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.5 Intended uses of spirotetramat i.e. supported uses for evaluation under Directive 91/414/EEC and for NAFTA 

Table B.7.5-1: The supported European use pattern of spirotetramat for Annex I – inclusion, and the intended European use pattern for MRL-setting (marked grey): 

Crop and/ 

or situation Country 

F 

G 

or 

I 

Pests or 

Group of 

pests 

controlled 

Formulation Application Application rate per treatment PHI Remarks: 

(a) (b) (c) 

Type 

(d-f) 

Conc. 

of as 

(i) 

method 

kind 

(f-h) 

growth 

stage & 

season 

(j) 

number 

min 

max 

(k) 

interval 

between 

appl. 

(min) 

kg 

as/hL 

min 

max 

water 

L/ha 

min 

max 

kg 

as/ha 

min 

max 

(days) 

(l) 

(m) 

Citrus all types 

EU-S F scales, 

aphids, mealy bugs, mites 

OD 150 spray BBCH 78 

at last application 

2 21 0.0096 1000 

L/ha and m CH*, max 3000 L/ha 

0.096 kg as./ha and m CH*, max 0.288 kg as./ha (3 metres) 

14 representative 

use for the EUevaluation 

Lettuce head and leafy 

EU-N EU-S 

F aphids OD 150 spray BBCH 48 

at last application 

max. 2 14 0.0072 - 

0.0144 

500-1000 

0.072 7 representative 

use for the EUevaluation 

Lettuce, head and leafy 

EU-N EU-S 

G aphids OD 150 spray BBCH 48 

at last application 

max. 2 14 0.0072 - 

0.0144 

500-1000 

0.072 7 representative 

use for the EUevaluation 

pome fruits apple/pears 

EU-N EU-S 

F aphids, 

scales, mites Psylla pyri 

SC 240 

& Mero 

spray BBCH 81 

at last application 

2 14 0.0144 500 

L/ha and m CH*, max 1500 L/ha 

0.072 kg as /ha and m CH*, max 0.216 kg as/ha 

21 all application 

data refer to metre CH* (canopy height, max. height referred to is three (3) metres 
- 28 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Crop and/ 

or situation Country 

F 

G 

or 

I 

Pests or 

Group of 

pests 

controlled 

Formulation Application Application rate per treatment PHI Remarks: 

(a) (b) (c) 

Type 

(d-f) 

Conc. 

of as 

(i) 

method 

kind 

(f-h) 

growth 

stage & 

season 

(j) 

number 

min 

max 

(k) 

interval 

between 

appl. 

(min) 

kg 

as/hL 

min 

max 

water 

L/ha 

min 

max 

kg 

as/ha 

min 

max 

(days) 

(l) 

(m) 

stone fruit plum sour and sweet cherry peach, apricot, nectarine 

EU-N EU-S 

F aphids, 

scales, mites 

SC 240 

& Mero 

spray BBCH 81 

at last application 

2 14 0.0144 500 

L/ha and m CH* max 1500 L/ha 

0.072 kg as /ha and m CH*, max 0.216 kg as./ha 

21 all application 

data refer to metre CH* (canopy height, max. height referred to is three (3) metres 

Grapes EU-N F mealybug, 

phylloxera 

OD 150 spray BBCH 82 2 14 0.0048-

0.0072 

1000-1500 

0.072 14 

Grapes EU-S F mealybugp

hylloxera 

OD 150 spray BBCH 82 2 14 0.0048-

0.0072 

1000-1500 

0.096 14 

Strawberries EU-N 

EU-S 

F aphids, 

whiteflies 

OD 150 spray BBCH 87 2 14 0.0096-

0.0192 

500-1000 

0.096 3 

Strawberries EU-N 

EU-S 

G aphids 

whiteflies 

OD 150 spray BBCH 87 2 14 0.0096-

0.0192 

500-1000 

0.096 3 

Onions EU-N F Thrips 

tabaci 

OD 150 spray BBCH 45 4 7 0.009-

0.012 

600-800 0.072 7 

fruiting vegetables tomatoes, peppers, aubergines 

EU-S F aphids, 

whiteflies, mites 

OD 150 spray BBCH 87 

at last application 

max 4 7 0.0072-

0.0096 

750-1000 

0.072 3 

fruiting vegetables tomatoes, peppers, aubergines 

EU-N EU-S 

G aphids, 

whiteflies, mites 

OD 150 spray BBCH 87 

at last application 

max 4 7 0.0096 750 

L/ha and metre CH*, max. 1500 L/ha 

0.072 kg as/ha and metre CH*, max. 0.144 kg as/ha 

3 all application 

data refers to metre CH* (canopy height), as fruiting vegetables in greenhouses may grow up to two (2) metres 
- 29 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Crop and/ 

or situation Country 

F 

G 

or 

I 

Pests or 

Group of 

pests 

controlled 

Formulation Application Application rate per treatment PHI Remarks: 

(a) (b) (c) 

Type 

(d-f) 

Conc. 

of as 

(i) 

method 

kind 

(f-h) 

growth 

stage & 

season 

(j) 

number 

min 

max 

(k) 

interval 

between 

appl. 

(min) 

kg 

as/hL 

min 

max 

water 

L/ha 

min 

max 

kg 

as/ha 

min 

max 

(days) 

(l) 

(m) 

Cucurbit vegetables cucumbers, courgettes, melon, watermelon 

EU-S F aphids, 

whiteflies, mites 

OD 150 spray BBCH 87 

at last application 

max 4 7 0.0096 750 0.072 3 

Cucurbit vegetables cucumbers, courgettes, 

EU-N EU-S 

G aphids, 

whiteflies, mites 

OD 150 spray BBCH 87 

at last application 

max 4 7 0.0096 750 

L/ha and m CH*, max 1500 L/ha 

0.072 kg as/ha and m CH*, max 0.144 kg as/ha 

3 all application 

data refers to metre CH* (canopy height, as cucumbers in greenhouses may grow up to two (2) metres 

Melon, watermelon 

EU-N EU-S 

G aphids, 

whiteflies, mites 

OD 150 spray BBCH 87 

at last application 

max 4 7 0.0096 750 0.072 3 

Flowering brassica (cauliflower, broccoli), head cabbage (red, white Savoy) 

EU-N EU-S 

F aphids OD 150 spray BBCH 79 

at last application 

max 2 14 0.0072 

– 0.0144 

500-1000 

0.072 3 

Brussels sprouts, kohlrabi 

EU-N F aphids OD 150 spray BBCH 79 

at last application 

max 2 14 0.0072 

– 0.0144 

500-1000 

0.072 3 

Leafy brassica 

EU-N EU-S 

F aphids OD 150 spray BBCH 79 

at last application 

max 3 14 0.0072 

– 0.0144 

500-1000 

0.072 3 
- 30 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Crop and/ 

or situation Country 

F 

G 

or 

I 

Pests or 

Group of 

pests 

controlled 

Formulation Application Application rate per treatment PHI Remarks: 

(a) (b) (c) 

Type 

(d-f) 

Conc. 

of as 

(i) 

method 

kind 

(f-h) 

growth 

stage & 

season 

(j) 

number 

min 

max 

(k) 

interval 

between 

appl. 

(min) 

kg 

as/hL 

min 

max 

water 

L/ha 

min 

max 

kg 

as/ha 

min 

max 

(days) 

(l) 

(m) 

Beans, green 

EU-N EU-S 

G aphids, 

whiteflies, mites 

OD 150 spray BBCH 87 4 7 0.0048-

0.0096 

750 L/ha and m CH*, max 1500 L/ha 

0.072 kg as/ha and m CH*, max 144 kg as/ha 

14 max. 2 metres of 

plant height 

Hops EU-N F aphids, 

scales, mites 

OD 150 spray BBCH 75 1 n.a. 0.007 - 

0.0045 

2200 - 3300- 

0.150 14 

* CH: Canopy Height 

Table B.7.5-2: Summary of representative uses evaluated (spirotetramat), and the intended American use pattern for MRL: Crop and/ or situation 

Member State or Country 

F G or I 

Pests or Group of pests controlled 

Preparation Application 

Application rate per treatment (for explanation see the text in front of this section) 

PHI (days) Remarks 

(a) (b) (c) 

Type (d-f) 

Conc. of as (i) 

method kind (f-h) 

growth stage & season (j) 

number min/ max (k) 

interval between applications (min) 

kg as/hL min – max (l) 

water L/ha min – max 

kg as/ha min – max (l) 

(m) 

Citrus all types 

USA F Scales, 

aphids, mealy bugs, mites, leafminer, whiteflies ,citrus psyllid 

OD SC 

150 240 

Spray 1-3 21 0.088 – 

0.176 

1 Max. dose per 

season is 0.351 kg/ha 
- 31 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Pome Fruits Apples/ pears/ quinces/etc. 

USA/ Canada 

F Aphids, 

scales, mites, mealy bugs, Psylla pyri 

OD SC 

150 240 

spray 1-3 14 0.088 – 

0.154 

7 Max. dose per 

season is 0.439 kg/ha 

Stone fruit Plum, sour and sweet cherry, peach, apricot, nectarine, etc. 

USA/ Canada 

F Aphids, 

scales, mites, mealy bugs 

OD SC 

150 240 

spray 1-3 14 0.088 – 

0.154 

7 Max. dose per 

season is 0.263 kg/ha 

Tree nuts All types 

USA/ Canada 

F Aphids, 

scales, mealy bugs, phylloxera 

OD SC 

150 240 

spray 1-3 14 0.088 – 

0.154 

7 Max. dose per 

season is 0.373 kg/ha 

Fruiting vegetables Tomatoes, peppers, eggplant, chili, ground cherry 

USA Canada 

F Aphids, 

whiteflies, psyllids, mites 

OD SC 

150 240 

spray 1-3 7 0.055 – 

0.088 

1 Max. dose per 

season is 0.176 kg/ha 

Cucurbit vegetables 

USA Canada 

F Aphids, 

whiteflies, spider mites 

OD SC 

150 240 

spray 1-3 7 0.055 – 

0.088 

1 Max. dose per 

season is 0.176 kg/ha 
- 32 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Leafy vegetables Brassicas (all types) and non brassicas (spinach, celery, endive, fennel, head and leaf lettuce, arugula, parsley, cress, radicchio, Swiss chard, rhubarb 

USA Canada 

F Aphids, 

whiteflies, diamondback moth 

OD SC 

150 240 

spray 1-3 7 0.055 – 

0.088 

Brassica crops: 1 Leafy, nonbrassica crops: 3 

Max. dose per season is 0.176 kg/ha 

hops USA F Aphids, 

mites 

OD SC 

150 240 

spray 1 - 2 14 0.088 – 

0.110 

7 Max. dose per 

season is 0.219 

grapes USA 

Canada 

F Mealy bugs, 

phylloxera, mites, scales 

OD SC 

150 240 

spray 1 - 2 30 0.088 – 

0.132 

7 Max. dose per 

season is 0.219 kg/ha 
- 33 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Tuber vegetables Arracacha, arrowroot, artichokes, canna, cassava, chayote, chufa, dasheen, ginger, leren, potato, sweet potato, tanier, tumeric, yam 

USA Canada 

F Aphids, 

psyllids, whiteflies, mites, potato tubeworm 

OD SC 

150 240 

spray 1 - 2 7 0.066 – 

0.088 

7 Max. dose per 

season is 0.176 kg/ha 

∗ For uses where the column "Remarks" is marked in grey further consideration is necessary. Uses should be crossed out when the notifier no longer supports this use(s). ** The rate range listed is the lowest and highest rate approved for use on a crop group. Specific rates for a pest(s) may vary (a) For crops, the EU and Codex classifications (both) should be taken into account; where relevant, the use situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), greenhouse application (G) or indoor application (I) (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds 

(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) 

(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) All abbreviations used must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant- type 

of equipment used must be indicated 

(i) g/kg or g/L. Normally the rate should be given for the active substance (according to ISO) and not for the variant in order to compare the rate for same active substances used in 

different variants (e.g. fluoroxypyr). (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, 

Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application (k) Indicate the minimum and maximum number of application possible under practical conditions of use (l) The values should be given in g or kg whatever gives the more manageable number (e.g. 200 kg/ha instead of 200 000 g/ha or 12.5 g/ha instead of 0.0125 kg/ha 

(m) PHI - minimum pre-harvest interval 
- 34 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.5-3: Summary of the representative uses evaluated (spirotetramat), and the intended Canadian use pattern for MRL: 

Crop and/ 

or 

situation 

Member 

State 

or 

Country 

F 

G 

or 

I 

Pests or 

Group of 

pests 

controlled Preparation Application 

Application rate per 

treatment** 

(for explanation see the text 

in front of this section) 

PHI 

(days) Remarks 

(a) (b) (c) 

Type 

(d-f) 

Conc. 

of as 

(i) 

method 

kind 

(f-h) 

growth 

stage & 

season 

(j) 

number 

min/ 

max 

(k) 

interval 

between 

applicati

ons (min) 

kg 

as/hL min – 

max 

(l) 

water 

L/ha 

min – 

max 

kg 

as/ha 

min – 

max 

(l) 

(m) 

Citrus all types 

USA F Scales, 

aphids, mealy bugs, mites, leafminer, whiteflies ,citrus psyllid 

OD SC 

150 240 

Spray 1-3 21 0.088 – 

0.176 

1 Max. dose per 

season is 0.351 kg/ha 

Pome Fruits Apples/ pears/ quinces/etc. 

Canada F Rosy apple 

aphid, apple aphids, San Jose scale, mealy bugs, pear psylla, whiteflies 

OD SC 

150 240 

spray 1-5 14 0.088 – 

0.140 

7 Max. dose per 

season is 0.440 kg/ha 

Stone fruit Plum, sour and sweet cherry, peach, apricot, nectarine, etc. 

Canada F Aphids, 

Whitelfies, San Jose scale, White peach scale, Lecanium scale, mealy bugs 

OD SC 

150 240 

spray 1-3 14 0.088 – 

0.140 

7 Max. dose per 

season is 0.270 kg/ha 
- 35 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Crop and/ 

or 

situation 

Member 

State 

or 

Country 

F 

G 

or 

I 

Pests or 

Group of 

pests 

controlled Preparation Application 

Application rate per 

treatment** 

(for explanation see the text 

in front of this section) 

PHI 

(days) Remarks 

(a) (b) (c) 

Type 

(d-f) 

Conc. 

of as 

(i) 

method 

kind 

(f-h) 

growth 

stage & 

season 

(j) 

number 

min/ 

max 

(k) 

interval 

between 

applicati

ons (min) 

kg 

as/hL min – 

max 

(l) 

water 

L/ha 

min – 

max 

kg 

as/ha 

min – 

max 

(l) 

(m) 

Tree nuts All types 

Canada F Aphids, 

Whiteflies, San Jose scale, Walnut scale, Lecanium scale, mealy bugs, phylloxera 

OD SC 

150 240 

spray 1-4 14 0.088 – 

0.140 

7 Max. dose per 

season is 0.380kg/ha 

Fruiting vegetables Tomatoes, peppers, eggplant, chili, ground cherry 

Canada F Aphids, 

whiteflies, psyllids, 

OD SC 

150 240 

spray 1-3 7 0.052 – 

0.088 

1 Max. dose per 

season is 0.175 kg/ha 

Cucurbit vegetables 

Canada F Aphids, 

whiteflies, 

OD SC 

150 240 

spray 1-3 7 0.052 – 

0.088 

1 Max. dose per 

season is 0.176 kg/ha 
- 36 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Crop and/ 

or 

situation 

Member 

State 

or 

Country 

F 

G 

or 

I 

Pests or 

Group of 

pests 

controlled Preparation Application 

Application rate per 

treatment** 

(for explanation see the text 

in front of this section) 

PHI 

(days) Remarks 

(a) (b) (c) 

Type 

(d-f) 

Conc. 

of as 

(i) 

method 

kind 

(f-h) 

growth 

stage & 

season 

(j) 

number 

min/ 

max 

(k) 

interval 

between 

applicati

ons (min) 

kg 

as/hL min – 

max 

(l) 

water 

L/ha 

min – 

max 

kg 

as/ha 

min – 

max 

(l) 

(m) 

Leafy vegetables Brassicas (all types) and non brassicas (spinach, celery, endive, fennel, head and leaf lettuce, arugula, parsley, cress, radicchio, Swiss chard, rhubarb 

Canada F Aphids, 

whiteflies, 

OD SC 

150 240 

spray 1-3 7 0.052 – 

0.088 

Brassica crops: 1 Leafy, nonbrassica crops: 3 

Max. dose per season is 0.175 kg/ha 

hops Canada F Hop aphid OD 

SC 

150 240 

spray 1 - 2 14 0.088 – 

0.105 

7 Max. dose per 

season is 0.220 

Grapes and small fruit vine climbing (except kiwifruit) 

Canada F Mealy bugs, 

phylloxera, whiteflies, Lecanium scale 

OD SC 

150 240 

spray 1 - 2 30 0.088 – 

0.140 

7 Max. dose per 

season is 0.220kg/ha 
- 37 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Crop and/ 

or 

situation 

Member 

State 

or 

Country 

F 

G 

or 

I 

Pests or 

Group of 

pests 

controlled Preparation Application 

Application rate per 

treatment** 

(for explanation see the text 

in front of this section) 

PHI 

(days) Remarks 

(a) (b) (c) 

Type 

(d-f) 

Conc. 

of as 

(i) 

method 

kind 

(f-h) 

growth 

stage & 

season 

(j) 

number 

min/ 

max 

(k) 

interval 

between 

applicati

ons (min) 

kg 

as/hL min – 

max 

(l) 

water 

L/ha 

min – 

max 

kg 

as/ha 

min – 

max 

(l) 

(m) 

Tuber vegetables Arracacha, arrowroot, artichokes, canna, cassava, chayote, chufa, dasheen, ginger, leren, potato, sweet potato, tanier, tumeric, yam 

Canada F Aphids, 

psyllids, whiteflies, 

OD SC 

150 240 

spray 1 - 2 7 0.052 – 

0.088 

7 Max. dose per 

season is 0.175 kg/ha 

∗ For uses where the column "Remarks" is marked in grey further consideration is necessary. Uses should be crossed out when the notifier no longer supports this use(s). ** The rate range listed is the lowest and highest rate approved for use on a crop group. Specific rates 

for a pest(s) may vary (a) For crops, the EU and Codex classifications (both) should be taken into account; where relevant, the use situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), greenhouse application (G) or indoor application (I) (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds 

(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) 

(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) All abbreviations used must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant- type of 

equipment used must be indicated 

(i) g/kg or g/L. Normally the rate should be given for the active substance (according to ISO) and not for the variant in order to compare the rate for same active substances used in 

different variants (e.g. fluoroxypyr). (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, 

Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application (k) Indicate the minimum and maximum number of application possible under practical conditions of use (l) The values should be given in g or kg whatever gives the more manageable number (e.g. 200 kg/ha instead of 200 000 g/ha or 12.5 g/ha instead of 0.0125 kg/ha 

(m) PHI - minimum pre-harvest interval 
- 38 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.6 Residues resulting from supervised trials (Annex IIA 6.3; Annex IIIA 8.3) 

Relevant for PMRA (Canada) and USEPA:

Summary information of the residue trials conducted in the NAFTA regions can be found in Annex II of this 

document. 

Relevant for EU:

Results from supervised residue trials in lettuce and citrus are reported representing the designated intended 

uses of this Annex II dossier for Annex I inclusion of spirotetramat (BYI08330). 

In addition, residue data from uses of spirotetramat in pome fruit, stone fruit, grapes, strawberries, onions, 

fruiting vegetables, brassica vegetables and hops are reported and evaluated in order to accelerate the fixing 

of MRLs with respect to Regulation 396/2005/EC. Thus, all possible MRLs are “peer-reviewed” and there is 

no need for additional work load after Annex I – inclusion for spirotetramat (approach supported by EFSA). 

Spirotetramat is applied as a spray solution to the different crops. Different formulations of spirotetramat 

were used: In 2004, residue trials were conducted with the OD 100 formulation of BYI08330. Due to a minor 

change of the final formulation from OD 100 to OD 150, residue trials in 2005 were conducted with the OD 

150 formulation of BYI08330. The composition of both formulations is similar; but the amount of the active 

substance is 100 g as/L in the OD 100 formulation and 150 g as/L in the OD 150 formulation. Applied at

identical use rates for the active substance, both formulations are considered to be comparable with respect 

to residues. 

Results from additional residue trials in lettuce, pome fruit and pepper are reported, which were conducted 

using the SC 240 formulation of BYI08330 with the addition of 0.2 % RME (rape methyl ester) to the spray 

solution. Moreover 4 residue trials, 2 trials in grapes and 2 trials in pepper were conducted with the SC 048 

formulation of BYI08330. The results of these trials are reported to give a complete picture of the BYI08330 

residue behaviour. 

Analysis of residue samples was conducted according to method 00875 (see Chapter IIA 4.3). The single 

analytes (spirotetramat and its metabolites BYI08330-enol, -ketohydroxy, -monohydroxy and -enol-glucoside) 

are determined by HPLC-MS/MS. The results are expressed as parent equivalents. The total residue of 

spirotetramat is calculated by summing up the values determined for the individual analytes expressed as 

parent equivalent. Expressed as parent equivalents the LOQ is 0.01 mg/kg for spirotetramat, 0.012 mg/kg for 

BYI08330-enol, -ketohydroxy and –monohydroxy and 0.08 mg/kg for BYI08330-enol-glucoside. For hop 

cones the respective LOQs are by a factor of 10 higher. The LOQ for the calculated total residue of 

BYI08330 is quoted at 0.054 mg/kg (hops 0.54 mg/kg). 

For each trial residues at the envisage PHI of the critical European GAP were evaluated. If, however, the 

total residue of spirotetramat at later intervals exceeded the total residue at the PHI, the higher values were 

evaluated to cover the worst case residue. The residue data of each trial used for the evaluation are marked 

in bold in the respective tables which summarise the residue results. 

B.7.6.1 Citrus fruits 

Spirotetramat is applied for control of scales, aphids, mealy bugs and mites in citrus. European residue data 

were submitted in two studies on oranges and two studies on mandarins to support the use of BYI08330 in 

citrus in southern Europe. The critical European GAP is summarized in Table B.7.6.1-1: 
- 39 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.1-1: GAP for residue situation in citrus fruits 

Indoor or 

outdoor 

Number of 

applications 

North or 

South of EU 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-S F 2 Spray BBCH 78 0.096 kg a.s./ha and m 

canopy height, max. 0.288 kg 

a.s./ha 

14 

Reference: Determination of residues of BYI08330 in/on orange after spraying of 

BYI08330 (100 OD) in the field in Italy, Portugal and Spain, 

Author(s), year: Schöning R., Helfrich P., 2005 

Report/Doc. number: RA-2032/04, including trials no. R 2004 0139/6, R 2004 0141/8, R 2004 0239/2, 

R 2004 0240/6 

M-263546-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: No 

Validity: yes 

Reference: Determination of residues of BYI08330 in/on orange after spraying of 

BYI08330 (150 OD) in the field in Portugal, Italy and Spain 

Author(s), year: Schöning R.; Wieland K.; 2006 

Report/Doc. number: RA-2003/05, including trials no. R 2005 0046/7, R 2005 0047/5, R 2005 0048/3, 

R 2005 0049/1 

M-269908-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: No 

Validity: yes 

Reference: Determination of residues of BYI08330 in/on mandarin after spraying of 

BYI08330 (100 OD) in the field in Italy, Portugal and Spain 

Author(s), year: Schöning R.; Helfrich P.; 2005 

Report/Doc. number: RA-2033/04, including trials no. R 2004 0142/6, R 2004 0143/6, R 2004 0237/6, 

R 2004 0238/4 

M-264450-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: No 

Validity: yes 
- 40 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of residues of BYI08330 in/on mandarin after spraying of 

BYI08330 (150 OD) in the field in Portugal, Spain and Italy 

Author(s), year: Schöning R.; Wieland K.; 2006 

Report/Doc. number: RA-2002/05, including trials no. R 2005 0041/6, R 2005 0042/4, R 2005 0043/2, 

R 2005 0044/0, R 2005 0045/9 

M-270179-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: yes 

Experimental design:

The magnitude of residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 

08330-mono-hydroxy and BYI 08330-enol-Glc in oranges and mandarins (fruit, peel and pulp) harvested 

following two applications with the formulations BYI 08330 (100 OD, 150 OD) to orange and mandarin trees 

in Southern Europe (Italy, Spain and Portugal) was determined. 

The formulations used were oil based dispersion concentrates containing 100 and 150 g/L spirotetramat. The 

product was used two times at application rates of 0.096 kg a.s./ha and meter canopy height and a water 

volume of 1000 L per ha and meter canopy height (2 – 3 m), this is corresponding to 0.192 – 0.288 kg 

a.s./ha. The last applications were carried out at growth stage between BBCH 79 and BBCH 87. Samples 

were taken before the last application, 0, 7, 14, 21 and 28 days after the last application. The distribution of 

the residues in peel and pulp was determined in specimens sampled 14, 21 and 28 days after application. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc were determined by HPLC-ESI-MS/MS according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on orange (fruit, peel and pulp), calculated as 

spirotetramat equivalent. 

The mean procedural recoveries at the fortification levels of 0.01 to 1.0 mg/kg for spirotetramat and its four 

metabolites ranged between 83 and 107 %; these results indicate that the methods used were suitable for 

this analysis. 

Findings:

A detailed summary of the residue trial for citrus fruits is given in Annex Ia. 

For Southern Europe 8 trials on oranges and 9 trials on mandarins were submitted according the critical 

GAP. The trials were mainly carried out in Italy, Spain and Portugal. All trials were carried out as residue 

decline studies and in addition to the residue results of the whole fruit also the results of peel and pulp were 

reported. The total residue of spirotetramat ranged between 0.064 and 0.233 mg/kg in orange fruit and 

between 0.101 and 0.331 mg/kg in mandarin fruit. Considering the whole citrus group the total residue 

ranged from 0.0645 to 0.331 mg/kg (STMR 0.14 mg/kg). 

In pulp, representing the edible part of citrus, the total residue ranged from <0.054 mg/kg to 0.146 mg/kg. In 

citrus peel, the total residue of spirotetramat was between 0.07 and 0.97 mg/kg. 

Spirotetramat and its enol metabolite were the main metabolites in orange and mandarin fruit, pulp and peel. 

BYI08330-ketohydroxy and the BYI08330-enol-glucoside were minor metabolites. BYI08330-monohydroxy 

was not found. 
- 41 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.1-2: Overview of European residue data for spirotetramat and its metabolites in 

citrus fruits used two times with application rates of 0.096 kg a.s./ha and meter canopy height, 

corresponding to 0.2112 - 0.288 kg a.s./ha: 

crop location portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

keto 

hydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

oranges Mineo, Italy, 

2004 

Fruit 

Fruit 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0* 

0 

7 

14 

14 

14 

21 

21 

21 

28 

28 

28 

0.01 

0.12 

0.03 

0.02 

<0.01 

0.05 

0.02 

<0.01 

0.03 

<0.01 

<0.01 

0.01 

0.012 

0.012 

0.012 

0.012 

<0.012 

0.058 

0.012 

<0.012 

0.037 

<0.012 

<0.012 

0.027 

0.012 

0.012 

0.012 

0.012 

<0.012 

0.030 

0.012 

<0.012 

0.026 

<0.012 

<0.012 

0.024 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.008 

<0.008 

<0.008 

0.008 

<0.008 

<0.008 

0.008 

<0.054 

0.164 

0.074 

0.064

<0.054 

0.158 

0.064 

<0.054 

0.113 

<0.054 

<0.054 

0.081 

oranges Catania, 

Italy, 2004 

Fruit 

Fruit 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0* 

0 

14 

21 

21 

21 

28 

28 

28 

<0.01 

0.11 

0.02 

0.02 

<0.01 

0.02 

0.01 

<0.01 

0.01 

0.012 

0.018 

0.017 

0.014 

<0.012 

0.059 

0.012 

<0.012 

0.025 

0.012 

0.012 

0.012 

0.012 

<0.012 

0.018 

0.012 

<0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.008 

<0.008 

<0.008 

0.008 

<0.054 

0.16 

0.069

0.066 

<0.054 

0.117 

<0.054 

<0.054 

0.067 

oranges Palmela, 

Portugal, 

2004 

Fruit 

Fruit 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0* 

0 

7 

14 

14 

14 

21 

21 

21 

27 

27 

27 

<0.01 

0.13 

0.13 

0.04 

<0.01 

0.04 

0.02 

<0.01 

0.02 

0.01 

<0.01 

0.01 

<0.012 

0.023 

0.044 

0.041 

0.015 

0.11 

0.031 

<0.012 

0.049 

0.033 

0.015 

0.030 

<0.012 

<0.012 

0.014 

0.013 

<0.012 

0.032 

0.013 

<0.012 

0.026 

0.013 

<0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

0.008 

<0.008 

0.008 

0.008 

<0.008 

0.008 

0.008 

<0.008 

0.008 

<0.054 

0.185 

0.208 

0.114

0.057 

0.202 

0.084 

<0.054 

0.115 

0.076 

0.057 

0.072 

oranges Benifaió, 

Spain, 2004 

Fruit 

Fruit 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0* 

0 

15 

21 

21 

21 

28 

28 

28 

0.07 

0.14 

0.10 

0.08 

<0.01 

0.14 

0.05 

<0.01 

0.14 

0.052 

0.062 

0.090 

0.078 

0.063 

0.28 

0.064 

0,056 

0.20 

<0.012 

0.012 

0.015 

0.012 

<0.012 

0.035 

0.012 

<0.012 

0.033 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.011 

0.012 

0.016 

0,016 

0.008 

0.054 

0,017 

0.008 

0.052 

0.157 

0.238 

0.233

0.198 

0.105 

0.521 

0.155 

0.098 

0.437 

oranges Palmela, 

Portugal, 

2005 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel

0 

14 

14 

14 

21 

21 

21 

28 

28 

28

0.10 

0.01 

<0.01 

0.02 

<0.01 

<0.01 

0.01 

0.02 

<0.01 

0.01

0.020 

0.015 

<0.012 

0.031 

<0.012 

<0.012 

0.032 

0.012 

<0.012 

0.029

0.012 

0.012 

<0.012 

0.016 

<0.012 

<0.012 

0.015 

0.012 

<0.012 

0.012

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012

<0.008 

<0.008 

<0.008 

0.008 

<0.008 

<0.008 

0.008 

0.008 

<0.008 

0.008

0.152 

0.057 

<0.054 

0.087 

<0.054 

<0.054 

0.077 

0.064

<0.054 

0.071
- 42 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop location portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

keto 

hydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

oranges Carlentini, 

Italy, 2005 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0 

14 

14 

14 

21 

21 

21 

28 

28 

28 

0.20 

0.01 

<0.01 

0.03 

0.02 

<0.01 

0.05 

<0.01 

<0.01 

0.02 

0.013 

0.012 

<0.012 

0.044 

0.012 

<0.012 

0.044 

<0.012 

<0.012 

0.030 

0.012 

<0.012 

<0.012 

0.016 

0.012 

<0.012 

0.017 

<0.012 

<0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

0.008 

<0.008 

<0.008 

0.008 

<0.008 

<0.008 

0.008 

0.245 

<0.054 

<0.054 

0.11 

0.064

<0.054 

0.131 

<0.054 

<0.054 

0.082 

oranges Cullera, 

Spain, 2005 

Fruit 

Fruit 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0* 

0 

7 

14 

14 

14 

21 

21 

21 

28 

28 

28 

0.02 

0.10 

0.06 

0.05 

<0.01 

0.21 

0.02 

<0.01 

0.04 

0.01 

<0.01 

0.01 

0.036 

0.047 

0.049 

0.039 

0.034 

0.20 

0.038 

0.025 

0.098 

0.032 

0.022 

0.072 

0.012 

0.012 

0.024 

0.013 

<0.012 

0.069 

0.013 

<0.012 

0.044 

0.012 

<0.012 

0.027 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.023 

0.008 

0.008 

0.016 

0.008 

0.008 

0.014 

0.088 

0.179 

0.153 

0.122

0.076 

0.514 

0.091 

0.067 

0.21 

0.074 

0.064 

0.135 

oranges Catania, 

Italy, 2005 

Fruit 

Fruit 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0* 

0 

7 

14 

14 

14 

21 

21 

21 

28 

28 

28 

0.04 

0.11 

0.04 

0.03 

<0.01 

0.06 

0.02 

<0.01 

0.05 

0.02 

<0.01 

0.04 

0.012 

0.012 

0.014 

0.015 

<0.012 

0.090 

0.016 

<0.012 

0.059 

0.013 

<0.012 

0.065 

0.013 

0.012 

0.012 

0.012 

<0.012 

0.042 

0.012 

<0.012 

0.029 

0.012 

<0.012 

0.035 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.008 

<0.008 

<0.008 

0.008 

<0.008 

<0.008 

0.008 

0.085 

0.154 

0.086 

0.077

<0.054 

0.212 

0.068 

<0.054 

0.158 

0.065 

<0.054 

0.16 

Mandarin Misterbianc

o, Italy, 

2004 

Fruit 

Fruit 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0* 

0 

7 

14 

14 

14 

21 

21 

21 

28 

28 

28 

0.02 

0.21 

0.02 

0.01 

<0.01 

0.03 

0.02 

<0.01 

0.03 

0.01 

<0.01 

0.01 

0.073 

0.13 

0.12 

0.075 

0.045 

0.24 

0.076 

0.053 

0.21 

0.069 

0.035 

0.11 

0.015 

0.023 

0.026 

0.019 

<0.012 

0.086 

0.023 

<0.012 

0.080 

0.017 

<0.012 

0.044 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.010 

0.012 

0.015 

0.014 

0.008 

0.048 

0.015 

0.008 

0.061 

0.018 

0.008 

0.044 

0.13 

0.387 

0.193 

0.13 

0.087 

0.416 

0.146

0.095 

0.393 

0.126 

0.077 

0.22 

Mandarin Chamusca, 

Portugal, 

2004 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

15 

15 

15 

21 

21 

21 

29 

29 

29 

0.01 

<0.01 

0.02 

0.01 

<0.01 

0.02 

0.01 

<0.01 

0.02 

0.15 

0.072 

0.21 

0.14 

0.077 

0.18 

0.10 

0.062 

0.13 

<0.012 

<0.012 

0.031 

<0.012 

<0.012 

0.026 

<0.012 

<0.012 

0.016 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.029 

0.008 

0.075 

0.035 

0.008 

0.081 

0.032 

0.008 

0.073 

0.213 

0.114 

0.348 

0.209

0.119 

0.319 

0.166 

0.104 

0.251 
- 43 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop location portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

keto 

hydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Mandarin Cullera, 

Spain, 2004 

Fruit 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0* 

0 

14 

14 

14 

21 

21 

21 

29 

29 

29 

0.03 

0.20 

0.09 

<0.01 

0.29 

0.06 

<0.01 

0.16 

0.03 

<0.01 

0.07 

0.070 

0.12 

0.15 

0.060 

0.43 

0.13 

0.054 

0.34 

0.12 

0.068 

0.20 

0.019 

0.026 

0.035 

0.012 

0.14 

0.036 

<0.012 

0.12 

0.026 

0.012 

0.068 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.020 

0.023 

0.044 

0.011 

0.12 

0.047 

0.011 

0.12 

0.050 

0.015 

0.10 

0.151 

0.381 

0.331

0.105 

0.992 

0.285 

0.099 

0.752 

0.238 

0.117 

0.45 

Mandarin Brenes, 

Spain, 2004 

Fruit 

Fruit 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel

0* 

0 

7 

15 

15 

15 

21 

21 

21 

28 

28 

28

0.03 

0.19 

0.01 

0.01 

<0.01 

0.01 

0.01 

<0.01 

0.01 

0.01 

<0.01 

0.01

0.066 

0.098 

0.088 

0.066 

0.045 

0.14 

0.069 

0.034 

0.11 

0.075 

0.022 

0.071

0.015 

0.016 

0.018 

0.013 

<0.012 

0.057 

0.012 

<0.012 

0.052 

0.013 

<0.012 

0.038

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012

0.018 

0.016 

0.018 

0.016 

0.008 

0.068 

0.021 

0.008 

0.065 

0.030 

0.008 

0.055

0.141 

0.332 

0.146 

0.117 

0.087 

0.287 

0.124 

0.076 

0.249 

0.140

0.064 

0.186

Mandarin Palmela, 

Portugal, 

2005 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0 

14 

14 

14

21 

21 

21 

28 

28 

28 

0.18 

0.01 

<0.01 

0.02 

0.01 

<0.01 

0.02 

0.01 

<0.01 

0.03 

0.084 

0.059 

0.032 

0.14 

0.045 

0.029 

0.11 

0.046 

0.032 

0.094 

0.012 

0.012 

<0.012 

0.026 

0.012 

<0.012 

0.026 

0.012 

<0.012 

0.030 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

<0.008 

0.019 

0.008 

<0.008 

0.020 

0.008 

<0.008 

0.026 

0.296 

0.101

0.074 

0.217 

0.087 

0.071 

0.188 

0.088 

0.074 

0.192 

Mandarin Alfarp, 

Spain, 2005 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0 

14 

14 

14 

21 

21 

21 

28 

28 

28 

0.11 

0.07 

0.01 

0.23 

0.04 

<0.01 

0.14 

0.06 

<0.01 

0.09 

0.078 

0.16 

0.098 

0.57 

0.12 

0.083 

0.30 

0.12 

0.10 

0.33 

0.012 

0.013 

0.012 

0.067 

0.012 

<0.012 

0.040 

0.014 

0.012 

0.051 

<0.012 

<0.012 

<0.012 

<0.012

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.018 

0.008 

0.064 

0.018 

0.008 

0.055 

0.025 

0.012 

0.085 

0.22 

0.273

0.14 

0.943 

0.202 

0.125 

0.547 

0.231 

0.146 

0.568 

Mandarin Vittoria, 

Italy, 2005 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0 

14 

14 

14 

21 

21 

21 

28 

28 

28 

0.15 

0.10 

<0.01 

0.24 

0.02 

<0.01 

0.04 

0.02 

<0.01 

0.04 

0.022 

0.033 

<0.012 

0.16 

0.031 

<0.012 

0.10 

0.034 

<0.012 

0.087 

0.013 

0.032 

<0.012 

0.11 

0.015 

<0.012 

0.064 

0.018 

<0.012 

0.046 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

0.008 

<0.008 

0.012 

0.008 

<0.008 

0.015 

0.008 

<0.008 

0.016 

0.205 

0.185

<0.054 

0.534 

0.086 

<0.054 

0.231 

0.092 

<0.054 

0.201 
- 44 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop location portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

keto 

hydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Mandarin Cullera, 

Spain, 2005 

Fruit 

Fruit 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0* 

0 

7 

14 

14 

14

21 

21 

21 

28 

28 

28 

0.03 

0.23 

0.14 

0.12 

<0.01 

0.25 

0.03 

<0.01 

0.07 

0.01 

<0.01 

0.03 

0.040 

0.086 

0.092 

0.057 

0.022 

0.22 

0.073 

0.028 

0.18 

0.061 

0.025 

0.13 

0.013 

0.019 

0.042 

0.031 

0.012 

0.12 

0.028 

0.012 

0.10 

0.021 

<0.012 

0.077 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.009 

0.10 

0.018 

0.012 

0.008 

0.054 

0.020 

0.008 

0.058 

0.018 

0.008 

0.053 

0.104 

0.447 

0.304 

0.232

0.064 

0.656 

0.163 

0.07 

0.42 

0.122 

0.067 

0.302 

Mandarin Misterbianc

o, Italy, 

2005 

Fruit 

Fruit 

Fruit 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

Fruit 

Pulp 

Peel 

0* 

0 

7 

14 

14 

14 

21 

21 

21 

28 

28 

28 

0.02 

0.19 

0.06 

0.04 

<0.01 

0.06 

0.04 

<0.01 

0.10 

0.03 

<0.01 

0.06 

0.041 

0.072 

0.075 

0.066 

0.016 

0.20 

0.069 

0.022 

0.23 

0.068 

0.023 

0.16 

0.012 

0.021 

0.036 

0.033 

<0.012 

0.11 

0.034 

<0.012 

0.14 

0.036 

<0.012 

0.096 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.011 

0.008 

0.014 

<0.008 

0.043 

0.018 

0.008 

0.064 

0.022 

0.008 

0.065 

0.093 

0.306 

0.191 

0.165 

0.058 

0.425 

0.173

0.064 

0.546 

0.168 

0.065 

0.393 

MRL-calculation based on data obtained from the Southern Region:

Both of the prescribed methods I and II have been used to calculate a proposed MRL for spirotetramat in 

citrus fruits (based on data obtained from trials of Southern Europe). 

Individual data points for oranges are: 

0.064 mg/kg, 0.064 mg/kg, 0.064 mg/kg, 0.069 mg/kg, 0.077 mg/kg, 0.114 mg/kg, 0.122 mg/kg and 

0.233 mg/kg, 

Mean residue: 0.101 mg/kg; standard deviation: 0.058 mg/kg 

STMR: 0.07 mg/kg 

Highest residue: 0.233 mg/kg 

Method I: Rmax = 0.287 mg/kg 

Method II: Rber = 0.240 mg/kg 

Based on the data available for oranges, a MRL of 0.3 mg/kg can be proposed. 

Individual data points for mandarins are: 

0.14 mg/kg, 0.146 mg/kg, 0.173 mg/kg, 0.185 mg/kg, 0.209 mg/kg, 0.232 mg/kg, 0.233 mg/kg, 0.273 mg/kg,

0.331 mg/kg 

Mean residue: 0.214 mg/kg; standard deviation: 0.062 mg/kg 

STMR: 0.209 mg/kg 

Highest residue: 0.331 mg/kg 

Method I: Rmax = 0.401 mg/kg 

Method II: Rber = 0.506 mg/kg 

Based on the data available for mandarins, a MRL of 0.5 mg/kg can be proposed.. 
- 45 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

In the following calculation all available data for citrus fruits (combining oranges and mandarins)were 

considered: 

Mean residue: 0.153 mg/kg; standard deviation: 0.081 mg/kg 

STMR: 0.140 mg/kg 

Highest residue: 0.331 mg/kg 

Method I: Rmax = 0.354 mg/kg 

Method II: Rber = 0.441 mg/kg 

Based on the available data a MRL of 0.5 mg/kg for citrus fruits (whole group) can be proposed. 

Conclusion:

In 17 residue trials on oranges and mandarins were carried out in Southern Europe. The residues in citrus 

fruits (oranges and mandarins) 14 days after last treatment (according to the intended uses) ranged between 

<0.054 mg/kg to 0.331 mg/kg. The different residue trials for citrus fruits were performed as residue decline 

studies with sampling intervals directly before the last application, 0, 7, 14, 21 and 28 days after the last 

treatment. The critical trials with highest residues levels were represented by the trials on mandarins. 

According to the SANCO guidance document 7525/VI/95-rev.7, 12/6/2001 it is possible to extrapolate from 

oranges and mandarins (8 trials each) to the whole group. Therefore the data are sufficient to propose an 

EU-MRL of 0.5 mg/kg for citrus fruits. 

Comments (RMS):

No comments. 

B.7.6.2 Lettuce 

Spirotetramat is applied for control of aphids in lettuce. To demonstrate the residue situation on lettuce in 

Europe four studies in greenhouse (20 residue trials), one field study in Northern Europe (4 trials) and one 

field study in Southern Europe (4 trials) were submitted. Most of the residue trials were performed using 3 

applications compared to 2 applications in the intended GAP. Details of the trial information are summarized 

in Annex Ib. The intended European GAP is summarized in Table B.7.6.2-1: 

Table B.7.6.2-1: GAP for residue situation in lettuce 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 2 Spray BBCH 48 0.072 g a.s./ha 7 

EU-S F 2 Spray BBCH 48 0.072 g a.s./ha 7 

EU-N/S G 2 Spray BBCH 48 0.072 g a.s./ha 7 

Reference: Determination of Residues of BYI08330 in/on Lettuce after Spraying of 

BYI08330 (150 OD) in the Greenhouse in Greece, France, Netherlands, 

Portugal Germany and Spain 

Author(s), year: Schöning R. ; 2006 

Report/Doc. number: RA-2170/05, including trials no. R 2005 1023/3, R 2005 1024/1, R 2005 1026/8, R 

2005 1027/6, R 2005 1028/4, R 2005 1029/2, R 2005 1030/6, R 2005 1031/4 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 
- 46 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of Residues of BYI08330 in/on Lettuce after Spraying of 

BYI08330 (100 OD) in the Greenhouse in Germany, Southern France, Italy 

and Spain 

Author(s), year: Schöning R.; Wolters A.; 2005 

Report/Doc. number: RA-2054/04, including trials no. R 2004 0393/3, R 2004 0394/1, R 2004 0396/8, R 

20040397/6, R 2004 0398/4, R 2004 0399/2, R 2004 0401/8, R 2004 0402/6 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 

Reference: Determination of Residues of BYI08330 in/on Lettuce after Spraying of 

BYI08330 (240 SC) in the Greenhouse in Germany, Italy and Spain 

Author(s), year: Schöning R.; Behn U.; 2005 

Report/Doc. number: RA-2113/04, including trials no. R 2004 0685/1, R 2004 0687/8, R 2004 0688/6, R 

2004 0689/4 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 

Reference: Determination of Residues of BYI08330 in/on Lettuce after Spraying of 

BYI08330 (100 OD) in the Field in the Netherlands and Germany 

Author(s), year: Schöning R.; Wolters A.; 2005 

Report/Doc. number: RA-2052/04, including trials no. R 2004 0385/2, R 2004 0386/0, R 2004 0387/9, R 

2004 0388/7 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 

Reference: Determination of Residues of BYI08330 in/on Lettuce after Spraying of 

BYI08330 (100 OD) in the Field in Southern France, Spain, Portugal and Italy 

Author(s), year: Schöning R.; Behn U.; 2005 

Report/Doc. number: RA-2053/04, including trials no. R 2004 0389/5, R 2004 0390/9, R 2004 0391/7, R 

2004 0392/5 

M-260382-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 

Experimental design:

The magnitude of residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 

08330-mono-hydroxy and BYI 08330-enol-Glc in/on lettuce harvested following the treatment with BYI 08330 
- 47 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

formulations (100 OD, 150 OD and 240 SC) in greenhouse (Greece, France, the Netherlander, Germany, 

Portugal and Spain) and under field conditions (N-EU: the Netherlands and Germany; S-EU: France, Spain, 

Portugal and Italy) was determined. 

Overall 28 residue trials with BYI08330 in lettuce were conducted in 2004 and 2005. An overview on the

supervised residue trials conducted with different formulations of BYI08330 is given in Table B.7.6.2-2 

Table B.7.6.2-2: Overview on European residue trials with BYI08330 in lettuce 

Location Formulation No. of 

trials Year Use rate (g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Greenhouse OD 100 8 2004 72 500-1000 3 7 

Greenhouse OD 150 8 2005 72 500-1000 2 14 

Greenhouse SC 240 + 0.2% 

RME EW500 

4 2004 72 500-1000 3 7 

Field N-EU OD 100 4 2004 72 500-1000 3 7 

Field S-EU OD 100 4 2004 72 500-1000 3 7 

In 2004, residue trials in lettuce were conducted in the greenhouse (12 trials) and in the field in northern (4 

trials) and in southern Europe (4 trials). These trials were not applied according to the intended European 

GAP. The different formulations were applied 3 times with a spray interval of 7 days. The last application was 

carried out at growth stage BBCH 32 – 49. The lettuce samples were taken before the last treatment, 0, 1, 3 

and 6-7 and 13-14 days after the last application. 

The greenhouse trials performed in 2005 were conducted with OD 150 formulation according the intended 

European GAP. The last applications were carried out at growth stage between BBCH 41 and BBCH 48. 

Samples were taken before the last application, 0, 1, 3, 7 and 14 days after the last application 

Different lettuce varieties were included in the residue trials. One half of the trials were conducted with head 

lettuce and the other half with loose-leaf varieties. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc were determined by HPLC-ESI-MS/MS according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on lettuce, calculated as spirotetramat equivalent. 

The mean procedural recoveries at the fortification levels of 0.01 to 10.0 mg/kg for spirotetramat and its four 

metabolites ranged between 84 and 96 %; these results indicate that the methods used were suitable for this 

analysis. 

Findings:

Most of the residue trials on lettuce were carried out with 3 applications per seasons. Number of applications 

and spray interval (6-8 days) in these submitted trials are not in accordance with the intended use for lettuce. 

8 of the greenhouse trials in Europe are performed according to the intended GAP. As Test substance BYI 

08330 100 OD was used in these trials. 

To evaluate the influence of different formulations of BYI 08330 (OD and SC) on the residue behaviour 

results was investigated by 8 greenhouse trials conducted with the OD 100 formulation and 4 greenhouse

trials conducted with the SC 240 formulation. In all these trials 3 spray applications of BYI08330 formulations 

were performed. There is no significant difference between these two formulation types (the results are listed 

in the table below). 

For the magnitude of spirotetramat residues under field conditions 4 trials from Northern Europe and four 

trials from the Southern area were submitted. Although all trials were carried out using 3 spray applications 

and shorter spray intervals of 6-8 days in stead of 14 days, the residues resulting from these trials were 

generally lower as those found in the greenhouse trials according to the intended use. Therefore the 

greenhouse trials are considered as worst case situation concerning the residue behaviour. For MRL 

calculation the 8 residue trials were used, which were conducted with the OD150 formulation in the 
- 48 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

greenhouse according to the critical European use pattern. Total residues of spirotetramat in lettuce of 

between 0.163 and 2.33 mg/kg (STMR 1.23 mg/kg) were determined. 

The total residue of spirotetramat consists mainly of active substance and the enol metabolite. BYI08330-

ketohydroxy and –enol-glucoside are minor metabolites. BYI08330-monohydroxy was not found. 

A detailed summary of the residue results is given in Appendix Ib. 

Table B.7.6.2-3: Overview of European residue data for spirotetramat and its metabolites in lettuce 

used 2-3 times with application rates of 0.076 kg a.s./ha (residues are calculated as spirotetramat 

equivalent): 

crop / 

No of appl./ 

fomulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

keto 

hydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Greenhouse trials 

Lettuce / 2 

appl. 

150 OD 

Kato Souli, 

Greece, 

2005 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

14 

0.10 

1.5 

1.6 

1.4 

0.70 

0.58 

0.12 

0.31 

0.37 

0.40 

0.26 

0.28 

0.026 

0.039 

0.057 

0.063 

0.053 

0.053 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.027 

0.025 

0.033 

0.034 

0.032 

0.046 

0.285 

1.886 

2.072 

1.909 

1.057 

0.971 

Lettuce / 2 

appl. 

150 OD 

Quyilly, 

France, 2005 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

14 

0.11 

2.0 

2.1 

1.6 

0.19 

0.09 

0.038 

0.57 

0.16 

0.18 

0.078 

0.023 

0.063 

0.11 

0.15 

0.17 

0.084 

0.052 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.015 

0.022 

0.017 

0.018 

0.023 

0.013 

0.238 

2.714 

2.439 

1.98 

0.387 

0.19 

Lettuce / 2 

appl. 

150 OD 

RH Heiloo, 

Netherlands, 

2005 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

14 

0.45 

1.6 

1.5 

1.4 

1.3 

0.87 

0.18 

0.34 

0.30 

0.29 

0.35 

0.26 

0.063 

0.067 

0.085 

0.082 

0.086 

0.066 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.713 

2.027 

1.905 

1.792 

1.756 

1.216 

Lettuce / 2 

appl. 

150 OD 

Torres 

Vedras, 

Portugal, 

2005 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

14 

<0.01 

1.4 

1.6 

1.4 

0.17 

0.02 

<0.012 

1.0 

0.38 

0.33 

0.12 

0.043 

<0.012 

0.067 

0.11 

0.099 

0.034 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

0.015 

0.020 

0.045 

0.038 

0.024 

0.054 

2.494 

2.122 

1.886 

0.374 

0.111 

Lettuce / 2 

appl. 

150 OD 

St. Jory, 

France, 2005 

head 

head 

0 

7 

1.8 

1.5 

0.22 

0.23 

0.047 

0.081 

<0.012 

<0.012 

0.008 

0.012 

2.087 

1.835 

Lettuce / 2 

appl. 

150 OD 

Montfavet, 

France, 2005 

head 

head 

0 

7 

1.5 

0.85 

0.66 

0.41 

0.11 

0.12 

<0.012 

<0.012 

0.015 

0.014 

2.297 

1.406 

Lettuce / 2 

appl. 

150 OD 

Langenfeld, 

Germany, 

2005 

head 

head 

0 

7 

1.3 

0.05 

0.30 

0.056 

0.014 

0.031 

<0.012 

<0.012 

0.008 

0.014 

1.634 

0.163 

Lettuce / 2 

appl. 

150 OD 

Bigues i 

Riells, Spain, 

2005 

head 

head 

0 

7 

1.8 

1.6 

0.57 

0.58 

0.12 

0.12 

<0.012 

<0.012 

0.008 

0.015 

2.51 

2.327 

Lettuce / 

3 appl. 

100 OD 

Langenfeld, 

Germany, 

2004 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

13 

0.04 

0.35 

0.38 

0.28 

0.02 

0.01 

0.096 

0.35 

0.27 

0.25 

0.091 

0.053 

0.031 

0.076 

0.043 

0.061 

0.039 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.030 

0.037 

0.037 

0.052 

0.060 

0.081 

0.197

0.813 

0.73 

0.643 

0.21

0.157 
- 49 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

No of appl./ 

fomulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

keto 

hydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Lettuce / 3 

appl. 

100 OD 

Jory, 

Southern 

France, 2004 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

14 

0.07 

0.49 

0.63 

0.06 

0.02 

0.01 

0.12 

0.69 

0.32 

0.18 

0.080 

0.031 

0.041 

0.16 

0.090 

0.047 

0.025 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.022 

0.042 

0.027 

0.038 

0.059 

0.067 

0.253

1.382 

1.067 

0.325 

0.184

0.12 

Lettuce / 3 

appl. 

100 OD 

Leichlingen, 

Germany, 

2004 

head 

head 

head 

head 

0 

1 

3 

6 

2.2 

1.7 

1.5 

1.9 

0.66 

0.50 

0.54 

0.59 

0.079 

0.059 

0.070 

0.079 

<0.012 

<0.012 

<0.012 

<0.012 

0.014 

0.012 

0.017 

0.032 

2.953 

2.271 

2.127 

2.601

Lettuce / 3 

appl. 

100 OD 

Palidoro 

Fiumicino, 

Italy, 2004 

head 

head 

head 

head 

0 

1 

3 

7 

1.9 

1.7 

1.3 

1.2 

0.35 

0.37 

0.28 

0.21 

0.070 

0.072 

0.046 

0.032 

<0.012 

<0.012 

<0.012 

<0.012 

0.037 

0.042 

0.043 

0.048 

2.357 

2.184 

1.669 

1.49

Lettuce / 3 

appl. 

100 OD 

Monopoli, 

Italy, 2004 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

6 

14 

1.7 

5.9 

5.1 

3.7 

2.6 

0.60 

0.49 

0.73 

0.68 

0.76 

0.53 

0.24 

0.13 

0.14 

0.14 

0.17 

0.15 

0.079 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.051 

0.056 

0.052 

0.13 

0.15 

0.093 

2.371

6.826 

5.972 

4.76 

3.43

1.012 

Lettuce / 3 

appl. 

100 OD 

Bigues, 

Spain, 2004 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

14 

0.54 

1.4 

1.2 

0.73 

0.52 

0.39 

0.52 

0.75 

0.71 

0.60 

0.51 

0.22 

0.18 

0.24 

0.22 

0.22 

0.17 

0.081 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.057 

0.058 

0.071 

0.067 

0.084 

0.074 

1.297

2.448 

2.201 

1.617 

1.284

0.765 

Lettuce / 3 

appl. 

100 OD 

Monopoli, 

Italy, 2004 

head 

head 

head 

head 

0 

1 

3 

7 

2.2 

1.1 

1.4 

1.0 

0.55 

0.35 

0.31 

0.27 

0.18 

0.11 

0.093 

0.096 

<0.012 

<0.012 

<0.012 

<0.012 

0.056 

0.037 

0.049 

0.067 

2.986 

1.597 

1.852 

1.433

Lettuce / 3 

appl. 

100 OD 

Brenes, 

Spain, 2004 

head 

head 

head 

head 

0 

1 

3 

7 

2.8 

1.9 

2.6 

1.7 

0.25 

0.20 

0.31 

0.20 

0.041 

0.035 

0.052 

0.038 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

0.008 

3.091 

2.135 

2.962 

1.946

Lettuce / 3 

appl. 

240 SC 

Langenfeld, 

Germany, 

2004 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

13 

0.02 

0.42 

0.5 

0.31 

0.03 

0.01 

0.088 

0.38 

0.29 

0.21 

0.1 

0.054 

0.023 

0.093 

0.048 

0.037 

0.028 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.036 

0.042 

0.051 

0.056 

0.07 

0.084 

0.179 

0.947 

0.901 

0.625 

0.24 

0.172 

Lettuce / 3 

appl. 

240 SC 

Monopoli, 

Italy, 2004 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

14 

1.2 

4.2 

3.2 

1.7 

0.99 

0.21 

0.36 

0.66 

0.49 

0.62 

0.41 

0.23 

0.12 

0.15 

0.12 

0.14 

0.11 

0.069 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.042 

0.043 

0.042 

0.11 

0.12 

0.11 

1.734 

5.065 

3.864 

2.582 

1.642 

0.631 

Lettuce / 3 

appl. 

240 SC 

Brenes, 

Spain, 2004 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

1.1 

1.8 

2.2 

1.7 

1.5 

0.15 

0.21 

0.29 

0.18 

0.21 

0.036 

0.032 

0.05 

0.044 

0.044 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

1.306 

2.062 

2.56 

1.944 

1.774 

Lettuce / 3 

appl. 

240 SC 

Leichlingen, 

Germany, 

2004 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

6 

1.2 

2.1 

1.8 

1.6 

1.5 

0.19 

0.28 

0.25 

0.27 

0.21 

0.064 

0.081 

0.089 

0.08 

0.066 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.01 

0.012 

0.01 

0.13 

0.019 

1.476 

2.485 

2.161 

2.092 

1.807 
- 50 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

No of appl./ 

fomulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

keto 

hydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Field trials – Northern Europe 

Lettuce / 3 

appl. 

150 OD 

ZwaagdijkOost, 

Netherlands, 

2004 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

14 

0.03 

0.53 

0.46 

0.37 

0.17 

0.03 

0.085 

0.15 

0.18 

0.2 

0.1 

0.026 

0.05 

0.05 

0.057 

0.064 

0.082 

0.019 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.033 

0.031 

0.04 

0.057 

0.077 

0.063 

0.21 

0.773 

0.749 

0.703 

0.441 

0.15 

Lettuce / 3 

appl. 

150 OD 

Langenfeld, 

Germany, 

2004 

head 

head 

head 

head 

0 

1 

3 

6 

0.37 

0.39 

0.05 

0.01 

0.3 

0.24 

0.12 

0.055 

0.09 

0.074 

0.049 

0.021 

<0.012 

<0.012 

<0.012 

<0.012 

0.014 

0.015 

0.024 

0.019 

0.786 

0.731 

0.255 

0.117 

Lettuce / 3 

appl. 

150 OD 

BornheimSechten, 

Germany, 

2004 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

14 

0.24 

1.2 

1.2 

0.24 

0.09 

0.01 

0.14 

0.64 

0.46 

0.3 

0.13 

0.027 

0.15 

0.19 

0.18 

0.14 

0.065 

0.018 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.025 

0.028 

0.034 

0.038 

0.044 

0.033 

0.567 

2.07 

1.886 

0.73 

0.341 

0.1 

Lettuce / 3 

appl. 

150 OD 

Langenfeld, 

Germany, 

2004 

head 

head 

head 

head 

0 

1 

3 

6 

0.58 

0.13 

0.01 

0.01 

0.45 

0.26 

0.11 

0.068 

0.062 

0.057 

0.059 

0.028 

<0.012 

<0.012 

<0.012 

<0.012 

0.029 

0.028 

0.039 

0.033 

1.133 

0.487 

0.23 

0.151 

Field trials – Southern Europe 

Lettuce / 3 

appl. 

150 OD 

Lucenay, 

France, 2004 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

6 

14 

0.01 

0.01 

0.04 

0.02 

0.01 

<0.01 

0.046 

0.054 

0.13 

0.076 

0.043 

0.013 

0.022 

0.024 

0.034 

0.028 

0.017 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.011 

0.012 

0.02 

0.024 

0.024 

0.022 

0.101 

0.112 

0.236 

0.16 

0.106 

0.069 

Lettuce / 3 

appl. 

150 OD 

Vilanova del 

Vallés, 

Spain, 2004 

head 

head 

head 

head 

0 

1 

3 

7 

0.74 

0.3 

0.2 

0.04 

0.28 

0.31 

0.13 

0.041 

0.067 

0.086 

0.073 

0.02 

<0.012 

<0.012 

<0.012 

<0.012 

0.045 

0.046 

0.053 

0.042 

1.144 

0.754 

0.468 

0.155 

Lettuce / 3 

appl. 

150 OD 

Azueira, 

Portugal, 

2004 

head 

head 

head 

head 

head 

head 

0* 

0 

1 

3 

7 

14 

0.03 

1.3 

0.4 

0.33 

0.05 

0.02 

0.071 

0.52 

0.32 

0.19 

0.078 

0.029 

0.025 

0.056 

0.083 

0.085 

0.028 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.018 

0.02 

0.021 

0.021 

0.02 

0.014 

0.156 

1.908 

0.836 

0.638 

0.188 

0.087 

Lettuce / 3 

appl. 

150 OD 

Bologna, 

Italy, 2004 

head 

head 

head 

head 

0 

1 

3 

7 

0.85 

0.48 

0.26 

0.04 

0.16 

0.21 

0.2 

0.12 

0.039 

0.056 

0.087 

0.035 

<0.012 

<0.012 

<0.012 

<0.012 

0.037 

0.031 

0.05 

0.058 

1.098 

0.789 

0.609 

0.265 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used for 

spirotetramat in lettuce (based on data obtained from trials from Northern and Southern Europe and 

glasshouse): 

MRL-calculation based on data obtained from the Northern Region:

Individual data points for lettuce are: 

0.117 mg/kg, 0.151 mg/kg, 0.341 mg/kg and 0.441 mg/kg 

Mean residue: 0.263 mg/kg; standard deviation: 0.155 mg/kg 

STMR: 0.25 mg/kg 

Highest residue: 0.441 mg/kg 

Method I: Rmax = 1.057 mg/kg 
- 51 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Method II: Rber = 0.832 mg/kg 

Based on the data available for lettuce in Northern Europe, a MRL of 1 mg/kg can be proposed. 

MRL-calculation based on data obtained from the Southern Region:

Individual data points for lettuce are: 

0.106 mg/kg, 0.155 mg/kg, 0.188 mg/kg and 0.265 mg/kg 

Mean residue: 0.179 mg/kg; standard deviation: 0.067 mg/kg 

STMR: 0.17 mg/kg 

Highest residue: 0.265 mg/kg 

Method I: Rmax = 0.522 mg/kg 

Method II: Rber = 0.492 mg/kg 

Based on the data available for lettuce in Southern Europe, a MRL of 0.5 mg/kg can be proposed. 

MRL-calculation based on data obtained from the greenhouse trials:

Individual data points for lettuce are: 

0.163 mg/kg, 0.374 mg/kg, 0.387 mg/kg, 1.057 mg/kg, 1.406 mg/kg, 1.756 mg/kg, 1.835 mg/kg and 

2.327 mg/kg, 

Mean residue: 0.163 mg/kg; standard deviation: 0.798 mg/kg 

STMR: 1.23 mg/kg 

Highest residue: 2.33 mg/kg 

Method I: Rmax = 3.706 mg/kg 

Method II: Rber = 3.631 mg/kg 

Based on the data available for lettuce, a MRL of 5 mg/kg can be proposed. 

Conclusion:

All field trials and most of the greenhouse trials on lettuce were carried out with 3 applications per seasons. 

The number of applications and spray interval in these submitted trials are not in accordance with the

intended GAP. Although the overdosed application in the field trials, the occurring residues were below the 

residues found in greenhouse trials according the intended GAP. Therefore the 8 the Europe greenhouse 

trials, performed according to the intended use and were taken for MRL calculation. Based on these trials a 

MRL of 5 mg/kg can be proposed. 

Comments (RMS):

No comments. 

B.7.6.3 Pome fruit 

Spirotetramat is applied for control of aphids, scales, and mites in pome fruit. The critical European GAP for 

the use of BYI08330 in pome fruit in northern (N-EU) and southern Europe (S-EU) is summarized in Table

B.7.6.3-1 

Table B.7.6.3-1: GAP for residue situation in pome fruit 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 2 Spray BBCH 81 0.072 kg a.s./ha and m 

canopy height, max. 0.216 kg 

a.s./ha 

21 

EU-S F 2 Spray BBCH 81 0.072 kg a.s./ha and m 

canopy height, max. 0.216 kg 

a.s./ha 

21 
- 52 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of residues of BYI08330 in/on apple and pear after spraying 

and low-volume spraying of BYI08330 (100 OD) in the field in Germany, 

United Kingdom and Northern France 

Author(s), year: KIIA 6.3.1.3/01, Schöning R.; Helfrich P.; 2005 ; amended 12.01.2006 

Report/Doc. number: RA-2135/04, including trials no. R 2004 0795/5, R 2004 0796/3, R 2004 0797/1, 

R 2004 0799/8 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 

Reference: Determination of residues of BYI08330 in/on apple and pear after spraying of 

BYI08330 (150 OD) in the field in United Kingdom and Germany 

Author(s), year: Schöning R.; Eberhardt R ; 2006 

Report/Doc. number: RA-2012/05, including trials no. R 2005 0083/1, R 2005 0085/8, R 2005 0086/6, 

R 2005 0087/4, R 2005 1018/7 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: no 

Validity: yes 

Reference: Determination of residues of BYI08330 in/on apple and pear after spraying 

and low-volume spraying of BYI08330 (240 SC) in the field in Germany, 

United Kingdom and Northern France 

Author(s), year: Schöning R.; Helfrich P.; 2006 

Report/Doc. number: RA-2138/04, including trials no. R 2004 0809/9, R 2004 0810/2, R 2004 0811/0, 

R 2004 0812/9 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 

Reference: Determination of residues of BYI08330 in/on apple and pear after spraying 

and low-volume spraying of BYI08330 (100 OD) in the field in Italy, Spain and 

southern France 

Author(s), year: Schöning R.; Helfrich P.; 2006 

Report/Doc. number: RA-2137/04, including trials no. R 2004 0805/6, R 2004 0806/4, R 2004 0807/2, 

R 2004 0808/0 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 
- 53 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of residues of BYI08330 in/on apple and pear after spraying of 

BYI08330 (150 OD) in the field in United Kingdom and Germany 

Author(s), year: Schöning R.; Eberhardt R ; 2006 

Report/Doc. number: RA-2015/05, including trials no. R 2005 0088/2, R 2005 0089/0, R 2005 0090/4, 

R 2005 0091/2 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: no 

Validity: yes 

Reference: Determination of residues of BYI08330 in/on apple and pear after spraying 

and low-volume spraying of BYI08330 (240 SC) in the field in Italy, Spain and 

southern France 

Author(s), year: Schöning R.; Helfrich P.; 2006 

Report/Doc. number: RA-2136/04, including trials no. R 2004 0800/5, R 2004 0801/3, R 2004 0802/1, 

R 2004 0804/8 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 

Experimental design

For the Northern European region 13 residue decline trials (Germany, France and UK) were conducted. Nine 

of these trials were performed using oil based dispersion concentrates containing 150 g/L and 100 g/L of 

spirotetramat. The remaining four trials were carried out with a suspension concentrate containing 240 g 

spirotetramat/L. In three of these trials the Additive RME 500 EW was added. 

For Southern Europe 12 residue trials were performed in Italy, Spain and S-France. Four trials each were 

performed with the three different formulations mentioned in the table below. 

In 3 of these 8 trials conducted with the SC 240 formulation of spirotetramat the additive RME EW500 was 

not added at the recommended concentration of 0.2 %: RME was not added to the spray liquid at all (R 2004 

0810/2), it was added to the spray liquid at the second application (R2004 0811/0), only, or was added at 

both applications at a reduced rate of 0.14 % (R 2004 0804/8). 

The product was used twice with an application rate of 0.072 kg a.s./ha and meter height of leaf surface (2 – 

3 m), resulting application rates between 0.144 and 0.2160 kg a.s./ha. All trials were performed according to 

the critical European GAP. 

Due to different agricultural practices in European countries different rates of water are used for spray 

applications in pome fruit. In most cases a water rate of 500 L/ha x m canopy height (CH) was used. To

cover the low volume application technique, in 4 trials a water volume of 250-300 L/ha x m CH was applied, 

while keeping the rate for the active substance at 72 g/ ha x m CH. 

An overview on the supervised residue trials is given in Table B.7.6.3-2. 

Table B.7.6.3-2: Overview on supervised residue trials with BYI08330 in pome fruit 

Study no. Region Formulation 

No. of 

trials Year 

Use rate 

(g as/ha x m 

CH) 

Water 

volume 

(L/ha x m 

CH) (a)

No of 

appl. 

Spray 

interval 

(days)

PHI 

days

RA-2135/04 N-EU OD 100 4 2004 72 300/500 2 14 21 

RA-2138/04 N-EU OD150 4 2004 72 300/500 2 14 21 

RA-2012/05 N-EU OD 150 5 2005 72 500 2 14 21 
- 54 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Study no. Region Formulation 

No. of 

trials Year 

Use rate 

(g as/ha x m 

CH) 

Water 

volume 

(L/ha x m 

CH) (a)

No of 

appl. 

Spray 

interval 

(days)

PHI 

days

RA-2137/04 S-EU SC 240 4 2004 72 250/500 2 14 21 

RA-2136/04 S-EU SC 240 4 2004 72 250/500 2 14 21 

RA-2015/05 S-EU OD150 4 2005 72 500 2 14 21 

The second application was carried out at BBCH growth stage 77-85. 

Apple and pear samples were taken before the last application, 0, 7, 14, 21 and 28 days after the last

application. In one study, in addition leaf samples were taken at 0, 2-3, 6-7 and 14 days after treatment. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc were determined by HPLC-ESI-MS/MS according to method 00857. 

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc were extracted from the sample material using with acidic acetonitrile/

water mixture (4/1, v/v). After filtration of the extract, the residues were quantified by reversed phase HPLC 

with Electro spray and MS/MS detection without any further clean-up step. The quantification was performed 

using a stable-labelled internal standard for each reference item. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on apples and pears, calculated as spirotetramat 

equivalent. 

The mean procedural recoveries at the fortification levels of 0.01 to 10.0 mg/kg for spirotetramat and its four 

metabolites ranged between 86 and 106 %; these results indicate that the methods used were suitable for 

this analysis. 

Findings:

A detailed summary of the residue trial for apples and pears is given in Annex Ic. 

The total residue of spirotetramat in apple and pear fruit from residue trials in Northern Europe after two 

applications ranged between 0.064 mg/kg and 0.254 mg/kg. Residues in pome fruit from southern European

residue trials were very similar ranging between <0.054 mg/kg (LOQ) and 0,249 mg/kg. 

Moreover, an influence of different formulations (OD100, OD150, SC240 with and without RME) or of the 

amount of water used for the spray application on the height of residues could not be observes. 

An overview of the European residue data for spirotetramat and its metabolites is given in the table below. 

Table B.7.6.3-3: Overview of European residue data for spirotetramat and its metabolites in pome 

fruit used 2 times with application rates of 0.076 kg a.s./ha and meter canopy height (residues are 

calculated as spirotetramat equivalent): 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

keto 

hydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Northern Europe 

Apple / 

100 OD 

Burscheid, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

0 

13 

21 

27 

0.10 

0.02 

0.01 

0.02 

<0.012 

0.016 

0.012 

0.012 

0.012 

0.014 

0.012 

0.017 

<0.012 

<0.012 

<0.012 

0.012 

< 0.008 

< 0.008 

< 0.008 

0.008 

0.144 

0.070 

0.054 

0.069 

Apple / 

100 OD 

Royston, 

United 

Kingdom, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0 

0 

7 

13 

21 

28 

0.07 

0.21 

0.12 

0.07 

0.04 

0.02 

0.014 

0.017 

0.025 

0.026 

0.034 

0.033 

0.012 

0.012 

0.018 

0.013 

0.021 

0.025 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.116 

0.259 

0.183 

0.129 

0.115 

0.098 
- 55 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

keto 

hydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

apple / 

150 OD 

Essex, UK, 

2005 

fruit 

leaf 

leaf 

leaf 

fruit 

leaf 

fruit 

fruit 

0 

0 

3 

6 

14 

14 

21 

29 

0.11 

9.5 

6.2 

5.5 

0.05 

3.2 

0.03 

0.01 

0.023 

0.77 

0.35 

0.6 

0.031 

0.17 

0.034 

0.021 

0.012 

0.59 

1.1 

1.1 

0.014 

1.3 

0.015 

0.019 

<0.012 

0.012 

0.012 

0.012 

<0.012 

0.012 

<0.012 

<0.012 

<0.008 

0.008 

0.008 

0.01 

<0.008 

0.011 

<0.008 

<0.008 

0.165 

10.88 

7.67 

7.222 

0.115 

4.693 

0.099 

0.07 

apple / 

150 OD 

Bernau, 

Germany, 

2005 

fruit 

fruit 

leaf 

leaf 

fruit 

leaf 

fruit 

leaf 

fruit 

fruit 

0* 

0 

0 

2 

7 

7 

14 

14 

21 

28 

0.02 

0.12 

13 

9.6 

0.1 

7.2 

0.03 

2.2 

0.03 

0.02 

0.016 

0.017 

0.79 

0.75 

0.022 

0.28 

0.019 

0.093 

0.021 

0.012 

0.012 

0.012 

0.76 

1.2 

0.015 

1.1 

0.018 

0.64 

0.023 

0.017 

<0.012 

<0.012 

0.019 

0.024 

0.012 

0.039 

0.012 

0.043 

0.012 

0.012 

<0.008 

<0.008 

0.008 

0.01 

<0.008 

0.017 

<0.008 

0.018 

0.008 

<0.008 

0.068 

0.169 

14.577 

11.584 

0.157 

8.636 

0.087 

2.994 

0.094 

0.069 

apple / 

150 OD 

WurzenRoitzsch, 

Germany, 

2005 

fruit 

fruit 

fruit 

fruit 

0 

15 

22 

29 

0.14 

0.08 

0.07 

0.06 

0.022 

0.049 

0.052 

0.037 

0.012 

0.012 

0.013 

0.012 

<0.012 

0.012 

0.012 

0.012 

<0.008 

<0.008 

0.008 

0.008 

0.194 

0.161 

0.155 

0.129 

apple / 

240 SC 

Burscheid, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.13 

0.01 

0.02 

0.01 

<0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

0.008 

<0.008 

0.174 

0.054 

0.064 

0.054 

apple / 

240 SC 

Royston, 

UK, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

13 

21 

28 

0.02 

0.23 

0.06 

<0.01 

0.02 

0.01 

<0.012 

0.012 

0.012 

<0.012 

0.012 

0.012 

<0.012 

0.012 

0.012 

<0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.064 

0.274 

0.104 

0.054 

0.064 

0.054 

pear / 

100 OD 

Burscheid, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

0 

13 

21 

27 

0.15 

0.02 

0.02 

0.01 

0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

0.194 

0.064 

0.064 

<0.054 

pear / 

100 OD 

Ecquevilly, 

France, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0 

0 

6 

13 

21 

27 

0.03 

0.14 

0.06 

0.06 

0.05 

0.03 

<0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.074 

0.184 

0.104 

0.104 

0.094 

0.074 

pear / 

150 OD 

Cambridge, 

UK, 2005 

fruit 

leaf 

leaf 

leaf 

fruit 

leaf 

fruit 

fruit 

0 

0 

3 

7 

14 

14 

21 

28 

0.38 

24 

19 

5.4 

0.08 

3.5 

0.05 

0.04 

0.024 

1.5 

0.56 

0.24 

0.012 

0.13 

0.012 

0.012 

0.012 

0.37 

0.97 

0.45 

0.022 

0.37 

0.016 

0.012 

0.012 

0.037 

0.072 

0.084 

0.012 

0.083 

0.012 

0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.436 

25.915 

20.61 

6.182 

0.134 

4.091 

0.098 

0.084 
- 56 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

keto 

hydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

pear / 

150 OD 

Geisenheim

Germany, 

2005 

fruit 

fruit 

leaf 

leaf 

fruit 

leaf 

fruit 

leaf 

fruit 

fruit 

0* 

0 

0 

3 

7 

7 

14 

14 

21 

28 

0.04 

0.25 

24 

22 

0.22 

19 

0.14 

13 

0.1 

0.06 

0.012 

0.023 

1.5 

0.43 

0.013 

0.56 

0.012 

0.44 

0.012 

0.012 

0.012 

0.012 

0.5 

0.78 

0.013 

0.53 

0.017 

0.77 

0.016 

0.014 

0.013 

0.014 

0.23 

0.21 

0.02 

0.22 

0.021 

0.25 

0.02 

0.021 

<0.008 

<0.008 

0.008 

0.009 

0.008 

0.008 

0.008 

0.008 

0.008 

<0.008 

0.085 

0.307 

26.238 

23.429 

0.274 

20.318 

0.198 

14.468 

0.156 

0.115 

pear / 

240 SC 

Burscheid, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

0 

13 

21 

27 

0.18 

0.15 

0.14 

0.14 

0.039 

0.034 

0.033 

0.031 

0.035 

0.033 

0.029 

0.027 

0.053 

0.046 

0.044 

0.043 

0.008 

0.008 

0.008 

0.008 

0.315 

0.271 

0.254 

0.249 

pear / 

240 SC 

Ecquevilly, 

N-France, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

6 

13 

21 

27 

0.03 

0.19 

0.11 

0.06 

0.07 

0.05 

<0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

0.012 

0.012 

0.012 

0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.008 

0.074 

0.234 

0.154 

0.104 

0.114 

0.094 

Southern Europe 

apple / 

100 OD 

Mirobello, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.30 

0.06 

0.04 

0.05 

0.019 

0.015 

0.014 

0.013 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

0.012 

<0.008 

<0.008 

<0.008 

<0.008 

0.351 

0.107 

0.086 

0.095 

pear / 

100 OD 

Merelli, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.27 

0.10 

0.07 

0.10 

0.033 

0.012 

0.012 

0.012 

0.02 

0.019 

0.013 

0.019 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

0.343 

0.151 

0.115 

0.151 

apple / 

100 OD 

Vilamacolu

m, Spain, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

10 

14 

20 

27 

0.09 

0.23 

0.20 

0.12 

0.10 

0.05 

0.013 

0.016 

0.023 

0.022 

0.015 

0.012 

0.019 

0.02 

0.034 

0.034 

0.041 

0.032 

0.017 

0.016 

0.027 

0.025 

0.028 

0.021 

<0.008 

0.008 

0.008 

0.008 

0.008 

0.008 

0.147 

0.29 

0.292 

0.209 

0.192 

0.123 

pear – 

100 OD 

Les Chères, 

S-France, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.12 

0.38 

0.18 

0.15 

0.14 

0.14 

0.030 

0.063 

0.038 

0.033 

0.033 

0.032 

0.026 

0.039 

0.034 

0.031 

0.027 

0.027 

0.032 

0.13 

0.053 

0.045 

0.041 

0.041 

0.008 

0.008 

0.008 

0.008 

0.008 

0.008 

0.216 

0.62 

0.313 

0.267 

0.249 

0.248 

apple / 

150 OD 

SaintPardoux, SFrance, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.03 

0.11 

0.08 

0.04 

0.04 

0.03 

0.012 

0.012 

0.012 

0.013 

0.022 

0.02 

<0.012 

<0.012 

0.012 

0.012 

0.014 

0.023 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.074 

0.154 

0.124 

0.085 

0.096 

0.093 

apple / 

150 OD 

Bologna, 

Italy, 2005 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.11 

0.06 

0.08 

0.02 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.015 

0.012 

0.012 

0.012 

0.014 

0.012 

<0.008 

0.008 

0.008 

0.008 

0.154 

0.104 

0.129 

0.064 

pear – 

150 OD 

Grenade, SFrance, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.04 

0.14 

0.05 

0.05 

0.02 

0.02 

0.012 

0.022 

0.012 

0.012 

0.012 

<0.012 

0.02 

0.016 

0.029 

0.029 

0.022 

0.018 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.092 

0.198 

0.111 

0.111 

0.074 

0.070 
- 57 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

keto 

hydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

pear – 

150 OD 

Albaro Di 

Ronco 

All’Adige, 

Italy, 2005 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.11 

0.03 

0.02 

0.01 

0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.014 

0.014 

<0.012 

<0.012 

<0.012 

0.012 

0.012 

<0.008 

<0.008 

<0.008 

<0.008 

0.154 

0.076 

0.066 

<0.054 

apple / 

240 SC + 

0.2 % RME 

500 EW 

Mirabello, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.35 

0.04 

0.01 

0.01 

0.019 

0.012 

0.012 

0.012 

0.015 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

0.404 

0.084 

<0.054 

0.054 

pear / 

240 SC + 

0.2 % RME 

500 EW 

Dodici 

Morelli, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.22 

0.1 

0.08 

0.09 

0.032 

0.012 

0.012 

0.012 

0.012 

0.024 

0.018 

0.018 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

0.284 

0.156 

0.13 

0.14 

apple / 

240 SC + 

0.2 % RME 

500 EW 

Vilamacolu

m, Spain, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

10 

14 

20 

27 

0.14 

0.33 

0.25 

0.11 

0.09 

0.05 

0.012 

0.012 

0.012 

0.013 

0.012 

0.012 

0.012 

0.012 

0.017 

0.019 

0.022 

0.014 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.184 

0.374 

0.299 

0.162 

0.144 

0.096 

pear – 

240 SC + 

0.14 % 

RME 500 

EW 

Les Chères, 

S-France, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

<0.01 

0.14 

0.02 

<0.01 

0.01 

<0.01 

<0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.012 

<0.012 

0.012 

<0.012 

<0.012 

0.012 

0.012 

<0.012 

0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.054 

0.184 

0.064 

0.054 

<0.054 

0.054 

The parent compound generally covered the main part of the total residue of spirotetramat. The enol and the 

ketohydroxy metabolite were also present at minor amounts. The monohydroxy metabolite was detected as 

minor metabolite in some trials. The enol-glucoside metabolite in pome fruit was only found in traces.

According to the guidance document SANCO 7525/VI/95/rev.7, table 3, it is possible to extrapolate from

apples or pears (with a minimum of 4 apples trials) to the whole group of pome fruit. Therefore all results of 

apples and pears were taken for the calculation of the MRL proposal. Both of the prescribed methods I and II 

have been used for MRL calculation for spirotetramat in pome fruit (based on data obtained from trials from 

Northern and Southern Europe): 

MRL-calculation based on data obtained from the Northern Region:

Individual data points for apple are: 

0.064 mg/kg, 0.064 mg/kg, 0.069 mg/kg, 0.094 mg/kg, 0.099 mg/kg, 0.115 mg/kg, 0.155 mg/kg, 

Individual data points for pear are: 

0.064 mg/kg, 0.094 mg/kg, 0.098 mg/kg, 0.114 mg/kg, 0.156 mg/kg, 0.254 mg/kg, 

Mean residue: 0.111 mg/kg; standard deviation: 0.053 mg/kg 

STMR: 0.098 mg/kg 

Highest residue: 0.254 mg/kg 

Method I: Rmax = 0.252 mg/kg 

Method II: Rber = 0.270 mg/kg 

Based on the data available for pome fruit in Northern Europe, a MRL of 0.3 mg/kg can be proposed. 

MRL-calculation based on data obtained from the Southern Region:

Individual data points for apple are: 

<0.054 mg/kg, 0.095 mg/kg, 0.096 mg/kg, 0.129 mg/kg, 0.144 mg/kg, 0.192 mg/kg, 

Individual data points for pear are: 

<0.054 mg/kg, 0.066 mg/kg, 0.074 mg/kg, 0.14 mg/kg, 0.151 mg/kg, 0.249 mg/kg 
- 58 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Mean residue: 0.120 mg/kg; standard deviation: 0.059 mg/kg 

STMR: 0.11 mg/kg 

Highest residue: 0.249 mg/kg 

Method I: Rmax = 0.283 mg/kg 

Method II: Rber = 0.299 mg/kg 

Based on the data available for pome fruit in southern Europe, a MRL of 0.3 mg/kg can be proposed. 

Conclusion: 

In 2004 and 2005, altogether 25 residue trials were conducted in pome fruit (apples and pears) in Northern 

and Southern Europe using three different formulations of spirotetramat, the OD 100, the OD 150 and the SC 

240 + 0.2 % RME EW 500. All trials were performed according to the intended European GAP. 

The residues in pome fruit from northern and southern Europe were very similar and resulted in the same 

MRL of 0.3 mg/kg. The highest residue in N-EU reached 0.254 mg/kg whereas in S-EU 0.249 mg/kg were 

found. In general no influence of the different locations (S-EU/N-EU) on the residue behaviour could be 

detected. 

Comments (RMS):

No comments. 

B.7.6.4 Stone fruit 

B.7.6.4.1 Peach and apricot 

Spirotetramat is applied for control of aphids, scales, and mites in peaches and apricots. The critical 

European GAP for the use in northern (N-EU) and southern Europe (S-EU) is summarized in Table 

B.7.6.4.1-1 

Table B.7.6.4-1: GAP for residue situation in peach and apricot 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 2 Spray BBCH 81 0.072 kg a.s./ha and m 

canopy height, max. 0.216 kg 

a.s./ha 

21 

EU-S F 2 Spray BBCH 81 0.072 kg a.s./ha and m 

canopy height, max. 0.216 kg 

a.s./ha 

21 

Reference: Determination of Residues of BYI08330 in/on Peach and Apricot after 

Spraying of BYI08330 (100 OD) in the Field in Northern France and Germany 

Author(s), year: Schöning R.; Wolters A.; 2005 

Report/Doc. number: RA-2126/04, 

including trials no. R 2004 0785/8, R 2004 0786/6 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 
- 59 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of Residues of BYI08330 in/on Peach and Apricot after 

Spraying of BYI08330 (150 OD) in the Field in Germany and Northern France 

Author(s), year: Schöning R.; Eberhardt R.; 2006 

Report/Doc. number: RA-2006/05, including trials no. R 2005 0059/9, R 2005 0060/2, R 2005 0061/0 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 

Reference: Determination of Residues of BYI08330 in/on Peach and Apricot after 

Spraying of BYI08330 (100 OD) in the Field in Spain and Italy 

Author(s), year: Schöning R.; Helfrich P.; 2006 

Report/Doc. number: RA-2127/04, including trials no. R 2004 0787/4, R 2004 0788/2, R 2004 0789/0, 

R 2004 0790/4 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 

Reference: Determination of Residues of BYI08330 in/on Apricot and Peach after 

Spraying of BYI08330 (150 OD) in the Field in Portugal, Spain, Greece, 

Southern France and Italy 

Author(s), year: Schöning R.; Eberhardt R.; 2006 

Report/Doc. number: RA-2007/05, including trials no. R 2005 0062/9, R 2005 0063/7, R 2005 0064/5, 

R 2005 0065/3, R 2005 0066/1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: yes 

Deviations: no 

Validity: yes 

Experimental design

For the Northern Europe, 5 residue decline trials (Germany and N-France) on apricot and peaches were 

conducted. Only two of these trials were carried out on peaches. 

Peaches and apricots are classified as minor crop in northern Europe and as major crop in southern Europe, 

but according to guidance document SANCO 7525/VI/95/rev.7, four trials are necessary to support a use for 

minor crops and extrapolation from peaches or apricots to the group nectarines, apricots and peaches can 

only be made with a minimum or 4 peaches trials. 

In Southern Europe 9 residue trials (4 on peaches and 5 on apricots) were performed in Italy, Spain, 

Portugal, Greece and S-France. 

All studies were carried out using oil based dispersion concentrates containing 150 g/L and 100 g/L of

spirotetramat. 

The product was used twice with an application rate of 0.072 kg a.s./ha and meter height of leaf surface (2 – 

3 m), resulting application rates between 0.144 and 0.2160 kg a.s./ha. All trials were performed according to 

the critical European GAP. 

Due to different agricultural practices in European countries different rates of water are used for spray 

applications. In most cases a water rate of 500 L/ha x m canopy height (CH) was used. To cover the low
- 60 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

volume application technique, in one trial (Northern Europe) a water volume of 300 L/ha and meter canopy 

height was applied, while keeping the rate for the active substance at 72 g/ ha x m canopy height. 

An overview on the supervised residue trials is given in Table B.7.6.4-2. 

Table B.7.6.4-2: Overview on supervised residue trials with BYI08330 in peach and apricot 

Study no. Region Formulation 

No. of 

trials Year 

Use rate 

(g as/ha x m 

CH) 

Water 

volume 

(L/ha x m 

CH) (a)

No of 

appl. 

Spray 

interval 

(days)

PHI 

days

RA-2126/04 N-EU OD 100 2 2004 72 500 2 14 21 

RA-2006/05 N-EU OD150 3 2005 72 300/500 2 14 21 

RA-2127/04 S-EU OD 100 4 2004 72 500 2 14-16 21-22 

RA-2007/05 S-EU OD150 5 2005 72 500 2 14 20-21 

The second application was carried out at BBCH growth stages 75-81. 

Apricot and peach samples were taken before the last application, 0, 7, 14, 21 and 28 days after the last 

application. 

Analytical method used in all studies:

The residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc in peach and apricot were determined by HPLC-ESI-MS/MS according to 

method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on peaches and apricots, calculated as spirotetramat

equivalent. 

The mean procedural recoveries at the fortification levels of 0.01 to 2.0 mg/kg for spirotetramat and its four 

metabolites ranged between 83 and 102 % and RSD < 20%; these results indicate that the methods used 

were suitable for this analysis. 

Findings:

A detailed summary of the residue trial for peaches and apricots is given in Annex Id. 

For Northern Europe, only two residue trials on peaches and three trials on apricots were submitted to

demonstrate the residue situation in peaches and apricots according the intended European GAP. 

Peaches and apricots are classified as minor crop in northern Europe and as major crop in southern Europe, 

but according to guidance document SANCO 7525/VI/95/rev.7, four trials are necessary to support a use for 

minor crops and extrapolation from peaches or apricots to nectarines, apricots and peaches can only be

made with a minimum or 4 peaches trials. 

Results from residue trials in Southern Europe conducted according to the intended European GAP showed

total residues of 0.115 to 0.687 mg/kg (STMR 0.345 mg/kg) in peaches and apricots sampled at the PHI of 

21 days after 2 applications of BYI 08330 formulations. 

The enol metabolite is a major component of the total residue in peaches and apricots appearing at amounts 

between 0.047 and 0.29 mg/kg. In peaches minor metabolites were the parent compound, the monohydroxy 

and ketohydroxy metabolites; the enol-glucoside metabolite was detected in traces only. In apricots the enolglucoside metabolite was detected at 0.11-0.43 mg/kg and could occur in similar amounts as the enol 

metabolite; the monohydroxy metabolite was detected in traces, only. 

An overview of the European residue data for spirotetramat and its metabolites is given in the table below. 
- 61 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.4-3: Overview of European residue data for spirotetramat and its metabolites in peaches 

and apricots used 2 times with application rates of 0.076 kg a.s./ha and meter canopy height 

(residues are calculated as spirotetramat equivalent): 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Northern Europe 

peach / OD 

100 

Pouligny 

Saint 

Pierre, NFrance, 

2004 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

27 

0.51 

0.10 

0.07 

0.07 

0.13 

0.24 

0.15 

0.15 

0.053 

0.041 

0.029 

0.032 

0.036 

0.057 

0.053 

0.053 

0.009 

0.013 

0.012 

0.012 

0.738 

0.451 

0.314 

0.317 

apricot / OD 

100 

Geisenheim

, Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.07 

0.26 

0.17 

0.12 

0.14 

0.09 

0.074 

0.094 

0.14 

0.12 

0.095 

0.077 

0.019 

0.016 

0.018 

0.013 

0.014 

0.013 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.15 

0.11 

0.18 

0.21 

0.25 

0.28 

0.325 

0.492 

0.520 

0.475 

0.511 

0.472 

apricot / OD 

150 

Höhnstedt, 

Germany, 

2005 

fruit 

fruit 

fruit 

0 

14 

21 

0.39 

0.07 

0.04 

0.25 

0.37 

0.29 

0.058 

0.044 

0.034 

0.012 

0.012 

0.012 

0.26 

0.37 

0.32 

0.970 

0.866 

0.696 

apricot / OD 

150 

Geisenheim

, Germany, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

0.10 

0.29 

0.15 

0.08 

0.07 

0.085 

0.092 

0.19 

0.21 

0.13 

0.012 

0.012 

0.014 

0.016 

0.018 

0.012 

0.012 

0.012 

0.012 

0.012 

0.082 

0.086 

0.17 

0.24 

0.29 

0.291 

0.492 

0.536 

0.558 

0.520 

peach / OD 

150 

Pouligny 

Saint 

Pierre, NFrance, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

27 

0.12 

0.26 

0.14 

0.10 

0.06 

0.04 

0.080 

0.088 

0.25 

0.24 

0.25 

0.18 

0.032 

0.032 

0.042 

0.033 

0.035 

0.027 

0.012 

0.012 

0.062 

0.074 

0.083 

0.065 

<0.008 

<0.008 

0.008 

0.009 

0.010 

0.009 

0.252 

0.400 

0.502 

0.456 

0.438 

0.321 

Southern Europe 

peach / OD 

100 

La Fortesa, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

0 

14 

22 

27 

0.48 

0.08 

0.04 

0.02 

0.23 

0.28 

0.19 

0.13 

0.057 

0.037 

0.027 

0.020 

0.03 

0.092 

0.081 

0.087 

0.008 

0.008 

0.008 

0.008 

0.805 

0.497 

0.346 

0.265 

apricot / OD 

100 

Bologna, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.42 

0.08 

0.07 

0.04 

0.27 

0.23 

0.14 

0.086 

0.041 

0.03 

0.023 

0.020 

0.012 

0.014 

0.016 

0.015 

0.22 

0.37 

0.43 

0.40 

0.963 

0.724 

0.679 

0.561 

peach / OD 

100 

Ravenna, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.08 

0.33 

0.15 

0.05 

0.03 

0.01 

0.048 

0.068 

0.12 

0.10 

0.071 

0.044 

0.044 

0.046 

0.050 

0.034 

0.017 

0.012 

0.023 

0.028 

0.039 

0.040 

0.044 

0.039 

0.008 

0.009 

0.009 

0.008 

0.008 

0.008 

0.203 

0.481 

0.368 

0.232 

0.170 

0.113 

apricot / OD 

100 

Pobla del 

Duc, Spain, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.01 

0.16 

0.07 

0.04 

0.02 

0.02 

0.048 

0.074 

0.093 

0.099 

0.13 

0.091 

0.012 

0.022 

0.023 

0.015 

0.014 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.012 

0.036 

0.050 

0.073 

0.077 

0.11 

0.12 

0.118 

0.318 

0.271 

0.243 

0.286 

0.255 

apricot / OD 

150 

Mato, 

Portugal, 

2005 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.61 

0.21 

0.09 

0.10 

0.40 

0.30 

0.16 

0.11 

0.094 

0.097 

0.085 

0.050 

0.012 

0.012 

0.012 

0.012 

0.12 

0.34 

0.34 

0.33 

1.236 

0.959 

0.687 

0.602 
- 62 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

peach / OD 

150 

La Fortesa, 

Spain, 2005 

fruit 

fruit 

fruit 

fruit 

0 

13 

20 

28 

0.35 

0.19 

0.09 

0.06 

0.062 

0.15 

0.093 

0.071 

0.034 

0.048 

0.016 

0.012 

0.020 

0.097 

0.10 

0.11 

0.008 

0.008 

0.008 

0.008 

0.474 

0.493 

0.307 

0.261 

apricot / OD 

150 

Souli 

Korinthias, 

Greece, 

2005 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.25 

0.15 

0.05 

0.05 

0.064 

0.094 

0.063 

0.039 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

0.012 

<0.012 

0.046 

0.10 

0.099 

0.10 

0.384 

0.368 

0.236 

0.213 

peach / OD 

150 

Montfavet, 

S-France, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.04 

0.22 

0.09 

0.05 

0.03 

0.02 

0.037 

0.061 

0.11 

0.071 

0.047 

0.054 

0.022 

0.022 

0.023 

0.014 

0.012 

0.012 

0.012 

0.012 

0.019 

0.022 

0.018 

0.019 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.119 

0.323 

0.25 

0.165 

0.115 

0.113 

apricot / OD 

150 

Bologna, 

Italy, 2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

27 

0.04 

0.12 

0.05 

0.03 

0.02 

0.02 

0.058 

0.079 

0.14 

0.10 

0.061 

0.040 

0.012 

0.014 

0.015 

0.012 

0.012 

0.013 

<0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.064 

0.074 

0.099 

0.11 

0.17 

0.16 

0.186 

0.299 

0.316 

0.264 

0.275 

0.245 

According to the SANCO guidance document 7525/VI/95/rev. 7, it is possible to extrapolate from peaches or 

apricots (with a minimum of 4 peaches trials) to nectarines, apricots and peaches. Therefore all results of 

peaches and apricots were taken for the calculation of the MRL proposal for Southern Europe. For the 

Northern region no extrapolation is possible according the above mentioned guidance paper. For a MRL 

proposal for the single commodities a minimum number of four trials is requested, therefore a MRL-proposal 

was calculated not calculated for Northern Europe, because of the lack of data. 

Both of the prescribed methods I and II have been used for MRL calculation for spirotetramat in peaches and 

apricots (based on data obtained from trials from Southern Europe): 

MRL-calculation based on data obtained from the Southern Region:

Individual data points for peach are: 

0.115 mg/kg, 0.17 mg/kg, 0.307 mg/kg, 0.346 mg/kg 

Individual data points for apricot are: 

0.236 mg/kg, 0.275 mg/kg, 0.286 mg/kg, 0.679 mg/kg, 0.687 mg/kg 

Mean residue: 0.345 mg/kg; standard deviation: 0.204 mg/kg 

STMR: 0.29 mg/kg 

Highest residue: 0.687 mg/kg 

Method I: Rmax = 0.964 mg/kg 

Method II: Rber = 1.025 mg/kg 

Based on the data available for peaches, nectarins and apricots in Southern Europe, a MRL of 1 mg/kg can 

be proposed. 

Conclusion: 

In 2004 and 2005, altogether 14 residue trials were conducted on peach and apricot in Northern and 

Southern Europe using two different formulations of spirotetramat (OD 100 and OD 150). All trials were

performed according to the intended European GAP. 
- 63 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

For Northern Europe 3 trials on apricot and only two trials on peaches were submitted. According to 

guidance document guidance document SANCO 7525/VI/95-rev.7, there are no sufficient data available to 

describe the residue situation in Northern Europe. 

The residues in peach and apricot from Southern Europe resulted in the MRL of 2 mg/kg. The highest 

residue in S-EU reached 0.254 mg/kg. 

Comments (RMS):

No comments. 

B.7.6.4.2 Plum 

Spirotetramat is applied for the use in plums for the control of aphids, scales, and mites. The critical 

European GAP for the use in northern (N-EU) and southern Europe (S-EU) is summarized in Table 

B.7.6.4.2-1. 

Table B.7.6.4.2-1: GAP for residue situation in plum 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 2 Spray BBCH 81 0.072 kg a.s./ha and m 

canopy height, max. 0.216 kg 

a.s./ha 

21 

EU-S F 2 Spray BBCH 81 0.072 kg a.s./ha and m 

canopy height, max. 0.216 kg 

a.s./ha 

21 

Reference: Determination of the residues of BYI08330 in/on plum after spraying of 

BYI08330 (100 OD) in the field in Germany, northern France and United 

Kingdom 

Author(s), year: Schöning R.; Helfrich P.; 2006 

Report/Doc. number: RA-2124/04, including trials no. R 2004 0774/2, R 2004 0775/0, R 2004 0776/9, R 

2004 0777/7 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on plum after spraying of 

BYI08330 (150 OD) in the field in United Kingdom, northern France and 

Germany 

Author(s), year: Schöning R.; 2006 

Report/Doc. number: RA-2004/05, including trials no. R 2005 0050/5, R 2005 0051/3, R 2005 0052/1, R 

2005 0054/8 

M-266052-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 
- 64 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of the residues of BYI08330 in/on plum after spraying of 

BYI08330 (100 OD) in the field in southern France and Italy 

Author(s), year: Schöning R.; Wolters A.; 2006 

Report/Doc. number: RA-2125/04, including trials no. R 2004 0778/5, R 2004 0779/3 

M-262626-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on plum after spraying of 

BYI08330 (150 OD) in the field in Italy and Spain 

Author(s), year: Schöning R.; 2006 

Report/Doc. number: RA-2005/05, including trials no. R 2005 0055/6, R 2005 0058/0 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

Altogether 12 supervised residue trials were conducted in plums in 2004 and 2005. 8 of these trials were 

carried out in the Northern European region (Germany, UK, N-France) and 4 trials in the South (S-France, 

Italy and Spain). The studies were carried out using oil based dispersion concentrate formulations, 

containing 150 g/L and 100 g/L of spirotetramat. 

The product was used two times with an application rate of 0.072 kg a.s./ha and meter height of leaf surface 

(2 – 3 m), resulting application rates between 0.144 and 0.2160 kg a.s./ha. All trials were performed 

according to the critical European GAP. 

An overview on the supervised residue trials is given in Table B.7.6.4.2-2. 

Table B.7.6.4.2-2: Overview on supervised residue trials with BYI08330 in plum 

Study no. Region Formulation 

No. of 

trials Year 

Use rate 

(g as/ha x m 

CH) 

Water 

volume 

(L/ha x m 

CH) (a)

No of 

appl. 

Spray 

interval 

(days)

PHI 

days

RA-2124/04 N-EU OD 100 4 2004 72 500 2 14 21-28 

RA-2004/05 N-EU OD150 4 2005 72 500 2 14 21-28 

RA-2125/04 S-EU OD 100 2 2004 72 500 2 14 21 

RA-2005/05 S-EU OD150 2 2005 72 500 2 14 21 

The second application was carried out at BBCH growth stage 75-81. 

The plums samples were taken before the last application, 0, 7, 14, 21 and 28 days after the last application. 

After the harvest the samples were frozen within a maximum of 24 hours after sampling and stored at – 18°C 

until analysis. 

Analytical method used in all studies:

Residues fruit were analysed according to method 00857 (see). Residues of spirotetramat and its 

metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-mono-hydroxy and BYI 08330-enol-Glc in 

peach and apricot were determined by HPLC-ESI-MS/MS according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on plums, calculated as spirotetramat equivalent. 
- 65 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The mean procedural recoveries at the fortification levels of 0.01 to 2.0 mg/kg for spirotetramat and its four 

metabolites ranged between 88 and 105% and RSD < 20%; these results indicate that the methods used 

were suitable for this analysis. 

Findings:

A detailed summary of the residue trial for plums is given in Annex I e. 

The total residue of spirotetramat in plums from eight residue trials in Northern Europe after two applications 

ranged between 0.119 mg/kg and 0.828 mg/kg. As plums are regarded as minor crops in Southern Europe 

four residue decline trials were performed. Residues resulting from these trials ranged between 0.135 mg/kg 

and 0.485 mg/kg. 

All residue trials were carried out according the intended GAP. 

The total residue of spirotetramat is composed of mainly BYI08330 enol (0.023 – 0.32 mg/kg parent 

equivalents). The parent compound, the ketohydroxy, the monohydroxy and enol-glucoside metabolite 

generally are minor compounds. In some trials the monohydroxy metabolite appeared at amounts similar to 

the enol metabolite (0.018 to 0.33 mg/kg). 

An overview of the European residue data for spirotetramat and its metabolites in plums is given in the table 

below. 

Table B.7.6.4.2-3: Overview of European residue data for spirotetramat and its metabolites in plums 

used 2 times with application rates of 0.076 kg a.s./ha and meter canopy height (residues are 

calculated as spirotetramat equivalent): 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Northern Europe 

plum / OD 

100 

WurzenRoitzsch, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.20 

0.08 

0.05 

0.04 

0.31 

0.45 

0.32 

0.29 

0.027 

0.041 

0.031 

0.038 

0.086 

0.25 

0.25 

0.33 

0.034 

0.11 

0.10 

0.13 

0.657 

0.931 

0.751 

0.828 

plum / OD 

100 

Burscheid, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.16 

0.02 

0.01 

0.01 

0.071 

0.061 

0.034 

0.015 

0.012 

0.012 

0.012 

0.012 

0.031 

0.072 

0.078 

0.084 

0.008 

0.020 

0.025 

0.024 

0.282 

0.185 

0.159 

0.145 

plum / OD 

100 

Pouligny St. 

Pierre, NFrance, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.08 

0.37 

0.16 

0.09 

0.07 

0.06 

0.21 

0.22 

0.31 

0.25 

0.26 

0.26 

0.027 

0.029 

0.029 

0.025 

0.025 

0.028 

0.049 

0.053 

0.058 

0.057 

0.064 

0.084 

0.05 

0.057 

0.078 

0.078 

0.11 

0.15 

0.416 

0.729 

0.635 

0.5 

0.529 

0.582 

plum / OD 

100 

Cambridge, 

UK, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.07 

0.25 

0.14 

0.10 

0.09 

0.07 

0.15 

0.15 

0.17 

0.17 

0.13 

0.14 

0.012 

0.012 

0.012 

0.015 

0.014 

0.017 

0.089 

0.085 

0.11 

0.13 

0.15 

0.20 

0.042 

0.042 

0.046 

0.055 

0.064 

0.084 

0.363 

0.539 

0.478 

0.47 

0.448 

0.511 

plum / OD 

150 

Cambridge, 

UK, 2005 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.16 

0.07 

0.04 

0.03 

0.092 

0.17 

0.19 

0.14 

0.012 

0.012 

0.012 

0.012 

0.017 

0.037 

0.078 

0.083 

0.008 

0.015 

0.033 

0.034 

0.289 

0.304 

0.353 

0.299 

plum / OD 

150 

Pouligny St. 

Pierre, 

France, 

2005 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.26 

0.06 

0.04 

0.03 

0.09 

0.099 

0.11 

0.063 

0.012 

0.012 

0.012 

0.012 

0.096 

0.21 

0.23 

0.19 

0.011 

0.019 

0.024 

0.016 

0.469 

0.400 

0.416 

0.311 
- 66 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

plum / OD 

150 

Monheim, 

Germany, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.01 

0.08 

0.05 

0.03 

0.02 

0.02 

0.023 

0.044 

0.095 

0.062 

0.027 

0.043 

0.012 

0.012 

0.017 

0.015 

0.017 

0.012 

0.012 

0.012 

0.062 

0.11 

0.098 

0.10 

<0.008 

<0.008 

0.009 

0.016 

0.016 

0.018 

0.065 

0.156 

0.233 

0.233 

0.178 

0.193 

plum / OD 

150 

WurzenRoitzsch, 

Germany, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.02 

0.08 

0.06 

0.05 

0.02 

0.03 

0.039 

0.052 

0.082 

0.074 

0.041 

0.043 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.014 

0.017 

0.019 

0.021 

0.018 

0.022 

0.008 

0.008 

0.010 

0.009 

0.010 

0.012 

0.093 

0.169 

0.183 

0.166 

0.101 

0.119 

Southern Europe 

plum / OD 

100 

Fronton, SFrance, 

2004 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.15 

0.09 

0.06 

0.05 

0.12 

0.19 

0.16 

0.11 

0.013 

0.021 

0.021 

0.02 

0.073 

0.19 

0.2 

0.22 

0.022 

0.043 

0.044 

0.044 

0.378 

0.534 

0.485 

0.444 

plum / OD 

100 

Ravenna, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.03 

0.21 

0.11 

0.04 

0.03 

0.02 

0.093 

0.096 

0.18 

0.15 

0.092 

0.06 

0.014 

0.018 

0.018 

0.016 

0.013 

0.012 

0.012 

0.012 

0.014 

0.02 

0.023 

0.029 

0.009 

0.009 

0.014 

0.021 

0.023 

0.028 

0.158 

0.345 

0.336 

0.247 

0.181 

0.149 

plum / OD 

150 

Viglona, 

Italy, 2005 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.34 

0.09 

0.08 

0.03 

0.055 

0.12 

0.088 

0.037 

0.012 

0.012 

0.012 

0.012 

0.054 

0.13 

0.17 

0.15 

0.018 

0.04 

0.045 

0.036 

0.479 

0.392 

0.395 

0.265 

plum / OD 

150 

Pobla del 

Duc, Spain, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.03 

0.12 

0.11 

0.07 

0.05 

0.03 

0.036 

0.047 

0.063 

0.054 

0.044 

0.025 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.018 

0.021 

0.021 

<0.008 

0.008 

0.008 

0.008 

0.008 

0.009 

0.09 

0.199 

0.205 

0.162 

0.135 

0.097 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used for 

spirotetramat in plums (based on data obtained from trials from Northern and Southern Europe): 

MRL-calculation based on data obtained from the Northern Region:

Individual data points for plum are: 

0.119 mg/kg, 0.145 mg/kg, 0.193 mg/kg, 0.353 mg/kg, 0.416 mg/kg, 0.511 mg/kg, 0.582 mg/kg, 0.828 mg/kg, 

Mean residue: 0.393 mg/kg; standard deviation: 0.244 mg/kg 

STMR: 0.38 mg/kg 

Highest residue: 0.828 mg/kg 

Method I: Rmax = 1.172 mg/kg 

Method II: Rber = 1.129 mg/kg 

Based on the data available for plum in Northern Europe, a MRL of 2 mg/kg can be proposed. 

MRL-calculation based on data obtained from the Southern Region:

Individual data points for plum are: 

0.135 mg/kg, 0.181 mg/kg, 0.395 mg/kg, 0.485 mg/kg, 

Mean residue: 0.299 mg/kg; standard deviation: 0.168 mg/kg 

STMR: 0.29 mg/kg 

Highest residue: 0.485 mg/kg 
- 67 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Method I: Rmax = 1.163 mg/kg 

Method II: Rber = 0.9250 mg/kg 

Based on the data available for plum in Southern Europe, a MRL of 2 mg/kg can be proposed. 

Conclusion:

During 2004 and 2005 altogether 12 residue trials were carried out on plums in North and South Europe 

according to the intended GAP. The trials were conducted using BYI 08330 OD 100 and BYI 08330 OD 150 

as formulations. The residues in plums were similar and resulted in a MRL of 2 mg/kg of spirotetramat and its 

metabolites. The highest residue in N-EU reached 0.828 mg/kg whereas in S-EU 0.485 mg/kg were found. 

Comments (RMS):

No comments. 

B.7.6.4.3 Cherry 

Spirotetramat is supported for control of aphids, scales, and mites in peaches and apricots. The critical 

European GAP for the use in northern (N-EU) and southern Europe (S-EU) is summarized in Table 

B.7.6.4.3-1. 

Table B.7.6.4.3-1: GAP for residue situation in cherry 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 2 Spray BBCH 81 0.072 kg a.s./ha and m 

canopy height, max. 0.216 kg 

a.s./ha 

21 

EU-S F 2 Spray BBCH 81 0.072 kg a.s./ha and m 

canopy height, max. 0.216 kg 

a.s./ha 

21 

Reference: Determination of the residues of BYI08330 in/on sweet cherry and sour 

cherry after spraying of BYI08330 (100 OD) in the field in northern France 

and Germany 

Author(s), year: Schöning R.; Behn, U. ; Wolters A.; 2006 

Report/Doc. number: RA-2119/04, including trials no. R 2004 0718/1, R 2004 0720/3, R 2004 0721/1, R 

2004 0723/8 

M-263879-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on sweet cherry and sour 

cherry after spraying of BYI08330 (150 OD) in the field in Germany and 

northern France 

Author(s), year: Schöning R.; Raecker T.; 2006 

Report/Doc. number: RA-2008/05, including trials no. R 2005 0068/8, R 2005 0071/8, R 2005 0072/6 

M-267524-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 
- 68 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of the residues of BYI08330 in/on sweet cherry after spraying 

of BYI08330 (100 OD) in the field in Italy and southern France 

Author(s), year: Schöning R.; Wolters A.; 2005 

Report/Doc. number: RA-2118/04, including trials no. R 2004 0716/5, R 2004 0717/3 

M-260405-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on sweet cherry after spraying 

of BYI08330 (150 OD) in the field in Italy and Spain 

Author(s), year: Schöning R.; Eberhardt R.; 2006 

Report/Doc. number: RA-2009/05, including trials no. R 2005 0073/4, R 2005 0074/2 

M-267488-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design

Spirotetramat is intended for use on sweet and sour cherries in Northern and Southern European regions. 

All studies were carried out in 2004 and 2005 using oil based dispersion concentrates containing 150 g/L and 

100 g/L of spirotetramat. 

For northern Europe 4 residue trials (Germany and N-France) on sweet cherries and three trials on sour

cherries were conducted. 

In southern Europe 4 residue trials on sweet cherries were performed in Italy, Spain and S-France. 

According to guidance document SANCO 7525/VI/95/rev.7, cherries are regarded as minor crops in Europe,

but for extrapolation four trials of each are necessary to extrapolate to the group cherry. 

The product was used twice with an application rate of 0.072 kg a.s./ha and meter height of leaf surface (2 – 

3 m), resulting application rates between 0.144 and 0.2160 kg a.s./ha. All trials were performed according to 

the critical European GAP. 

The second application was carried out at BBCH growth stage 75-85. 

All residue trials were conducted as residue decline studies. The specimens were taken before the last

application, 0, 7, 14, 21 and 28 days after the last application. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 76 to 211 days. 

Analytical method used in all studies:

Residues fruit were analysed according to method 00857 (see IIA Point 4.3.1). Mean concurrent recoveries 

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc in peach and apricot were determined by HPLC-ESI-MS/MS according to 

method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on cherries, calculated as spirotetramat equivalent.

The mean procedural recoveries at the fortification levels of 0.01 to 1.0 mg/kg for spirotetramat and its four 

metabolites ranged between 85 and 96 % and RSD < 20%; these results indicate that the methods used 

were suitable for this analysis. 
- 69 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Findings:

A detailed summary of the residue trial for cherries is given in Annex If. 

The total residue of spirotetramat in cherries from seven residue trials in Northern Europe after two 

applications ranged between 0.248 mg/kg and 0.939 mg/kg. Residues resulting from residue trials from 

Southern Europe ranged between 0.629 mg/kg and 1.045 mg/kg. 

All residue trials were carried out according the intended GAP. 

Control samples were performed at each location. In one control sample from a study in Northern Europe

(RA-209/05) a total residue of total spirotetramat was found at 0.55 mg/kg. The value was confirmed by the 

analysis of the retained sample, but no further explanation was given. 

Major component of the total residue of spirotetramat in all trials was the enol metabolite. All other

components were present at lower amounts. In cherries from some trials the monohydroxy metabolite could 

be detected at similar amounts as the enol metabolite. 

An overview of the European residue data for spirotetramat and its metabolites is given in the table below. 

Table B.7.6.4.3-2: Overview of European residue data for spirotetramat and its metabolites in cherries

used 2 times with application rates of 0.076 kg a.s./ha and meter canopy height (residues are 

calculated as spirotetramat equivalent): 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Northern Europe 

sweet 

cherry / OD 

100 

Pouligny 

Saint 

Pierre, NFrance, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

14 

21 

28 

0.09 

0.43 

0.02 

0.01 

0.01 

0.15 

0.25 

0.32 

0.32 

0.23 

0.18 

0.21 

0.19 

0.11 

0.089 

0.024 

0.026 

0.081 

0.12 

0.13 

0.008 

0.008 

0.018 

0.023 

0.026 

0.452 

0.924 

0.629 

0.583 

0.485 

sour cherry 

/ OD 100 

Wurzen 

Roitzsch, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

14 

21 

28 

0.12 

0.56 

0.03 

0.01 

0.01 

0.20 

0.25 

0.25 

0.21 

0.12 

0.10 

0.10 

0.06 

0.033 

0.024 

0.018 

0.017 

0.021 

0.021 

0.022 

0.017 

0.014 

0.013 

0.011 

0.013 

0.455 

0.941 

0.374 

0.285 

0.189 

sweet 

cherry / OD 

100 

Brain sur 

L’Authion, 

N-France, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

13 

21 

27 

0.03 

0.39 

0.03 

0.03 

0.02 

0.01 

0.70 

0.63 

0.79 

0.86 

0.58 

0.39 

0.11 

0.098 

0.087 

0.11 

0.072 

0.055 

0.069 

0.057 

0.093 

0.17 

0.17 

0.11 

0.054 

0.047 

0.057 

0.11 

0.097 

0.065 

0.963 

1.222 

1.057 

1.280 

0.939 

0.630 

sour cherry 

/ OD 100 

Burscheid, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.01 

0.51 

0.02 

0.01 

0.01 

<0.01 

0.099 

0.17 

0.41 

0.29 

0.21 

0.13 

0.013 

0.014 

0.018 

0.016 

0.012 

0.012 

0.012 

0.012 

0.019 

0.030 

0.040 

0.041 

0.008 

0.008 

0.011 

0.016 

0.023 

0.020 

0.142 

0.714 

0.478 

0.362 

0.295 

0.213 

sweet 

cherry / OD 

150 

Wurzen 

Roitzsch, 

Germany, 

2005 

fruit 

fruit 

fruit 

0 

14 

21 

0.69 

0.03 

0.02 

0.26 

0.53 

0.36 

0.052 

0.13 

0.13 

0.074 

0.17 

0.23 

0.018 

0.057 

0.086 

1.094 

0.917 

0.826 

sweet 

cherry / OD 

150 

Pouligny 

Saint 

Pierre, NFrance, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.03 

0.28 

0.04 

0.02 

0.01 

0.01 

0.092 

0.27 

0.44 

0.31 

0.23 

0.19 

0.072 

0.090 

0.12 

0.082 

0.068 

0.067 

0.012 

0.012 

0.049 

0.059 

0.091 

0.21 

0.008 

0.008 

0.011 

0.013 

0.018 

0.047 

0.214 

0.660 

0.660 

0.484 

0.417 

0.524 
- 70 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

sour cherry 

/ OD 150 

Monheim, 

Germany, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.02 

0.31 

0.10 

0.02 

<0.01 

<0.01 

0.041 

0.13 

0.30 

0.29 

0.15 

0.093 

0.035 

0.030 

0.046 

0.040 

0.022 

0.015 

0.012 

0.012 

0.033 

0.054 

0.037 

0.038 

0.008 

0.008 

0.024 

0.039 

0.029 

0.028 

0.116 

0.49 

0.503 

0.443 

0.248 

0.184 

Southern Europe 

sweet 

cherry / OD 

100 

Bisceglie, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

14 

21 

28 

0.04 

0.25 

0.04 

0.01 

<0.01 

0.18 

0.22 

0.48 

0.38 

0.24 

0.22 

0.23 

0.19 

0.11 

0.085 

0.029 

0.027 

0.067 

0.11 

0.10 

0.008 

0.008 

0.018 

0.019 

0.019 

0.477 

0.735 

0.795 

0.629 

0.454 

sweet 

cherry / OD 

100 

Monteux, SFrance, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

9 

14 

21 

28 

0.05 

0.43 

0.07 

0.06 

0.05 

0.02 

0.18 

0.28 

0.52 

0.50 

0.50 

0.35 

0.12 

0.12 

0.14 

0.11 

0.11 

0.086 

0.024 

0.022 

0.11 

0.21 

0.32 

0.37 

0.008 

0.008 

0.021 

0.038 

0.065 

0.071 

0.382 

0.86 

0.861 

0.918 

1.045 

0.897 

sweet 

cherry / OD 

150 

Andria, 

Italy, 2005 

fruit 

fruit 

fruit 

fruit 

0 

14 

21 

28 

0.29 

0.02 

0.01 

0.01 

0.77 

0.57 

0.35 

0.26 

0.093 

0.099 

0.055 

0.044 

0.54 

0.39 

0.22 

0.14 

0.11 

0.073 

0.044 

0.027 

1.803 

1.152 

0.679 

0.481 

sweet 

cherry / OD 

150 

Santa 

Coloma de 

Cervelló, 

Spain, 2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

7 

14 

21 

28 

0.01 

0.34 

0.12 

0.09 

0.06 

0.05 

0.29 

0.41 

0.47 

0.32 

0.22 

0.10 

0.072 

0.072 

0.076 

0.075 

0.073 

0.076 

0.083 

0.092 

0.20 

0.30 

0.29 

0.33 

0.017 

0.019 

0.042 

0.069 

0.078 

0.095 

0.472 

0.933 

0.908 

0.854 

0.721 

0.651 

According to the guidance document SANCO 7525/VI/95/rev. 7, cherries are regarded as minor crops in 

Europe and an extrapolation to the group cherry is possible from sweet and sour cherry with four trials each. 

Although only three residue trials on sour cherry were submitted all results of sweet and sour cherries were 

taken for the calculation of the MRL proposal for Northern Europe. For the Southern European region no

extrapolation is possible according the above mentioned guidance paper. 

For MRL calculation, both of the prescribed methods I and II have been used for spirotetramat in cherries 

(based on data obtained from trials from Southern Europe): 

MRL-calculation based on data obtained from the Northern Region:

Individual data points for sweet cherry are: 

0.524 mg/kg, 0.583 mg/kg, 0.826 mg/kg, 0.939 mg/kg, 

Individual data points for sour cherry are: 

0.248 mg/kg, 0.285 mg/kg, 0.295 mg/kg 

Mean residue: 0.829 mg/kg; standard deviation: 0.275 mg/kg 

STMR: 0.52 mg/kg 

Highest residue: 0.939 mg/kg 

Method I: Rmax = 1.463 mg/kg 

Method II: Rber = 1.652 mg/kg 

Based on the data available for cherries, a MRL of 2 mg/kg can be proposed. 

MRL-calculation based on data obtained from the Southern Region:

Individual data points for sweet cherries are: 

0.629 mg/kg, 0.679 mg/kg, 0.721 mg/kg, 1.045 mg/kg 
- 71 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Mean residue: 0.769mg/kg; standard deviation: 0.188 mg/kg 

STMR: 0.70 mg/kg; 

Highest residue: 1.045 mg/kg 

Method I: Rmax = 1.736 mg/kg 

Method II: Rber = 1.928 mg/kg 

Based on the data available for cherries, a MRL of 2 mg/kg can be proposed. 

Conclusion: 

In 2004 and 2005, altogether 13 residue trials were conducted on sweet and sour cherries in Northern and 

Southern Europe using two different formulations of spirotetramat (OD 100 and OD 150). All trials were

performed according to the intended European GAP. 

For Northern Europe 4 trials on sweet cherries and 3 trials on sour cherries were submitted and 4 trials on 

sweet cherries from Southern Europe. 

The residues in sweet and sour cherries from Northern and Southern Europe resulted in the MRL of 2 mg/kg. 

The highest residue was reached in Southern Europe with 1.045 mg/kg. 

Comments (RMS):

No comments. 

B.7.6.5 Berries and small fruits 

B.7.6.5.1 Grapes 

Spirotetramat is applied for the use in grapes for the control of mealy bugs and phylloxer. The critical 

European GAP for the use in Northern (N-EU) and Southern Europe (S-EU) is summarized in Table 

B.7.6.5.1-1: 

Table B.7.6.5.1-1: GAP for residue situation in grapes 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 2 Spray BBCH 82 0.072 kg a.s./ha 14 

EU-S F 2 Spray BBCH 82 0.096 kg a.s./ha 14 

Reference: Determination of the residues of BYI08330 in/on grape and table grape after 

spraying and low–volume spraying of BYI08330 (100 OD) in the field in Italy, 

Greece, Spain and southern France 

Author(s), year: Schöning R.; Eberhardt R.; 2006 

Report/Doc. number: RA-2049/04, including trials no. R 2004 0196/5, R 2004 0197/3, R 2004 0198/1, R 

2004 0201/5, R 2004 0202/3, R 2004 0203/1 

M-263864-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 
- 72 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of the residues of BYI08330 in/on grape after spraying of 

BYI08330 (150 OD) in the field in Spain and Italy 

Author(s), year: Ballesteros C.; Gateaud L.; 2006 

Report/Doc. number: RA-2034/05, including trials no. R 2005 0157/9, R 2005 0158/7 

M-270088-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on grape after spraying of 

BYI08330 (48 SC) in the field in France and Italy 

Author(s), year: Ballesteros C.; Gateaud L.; 2006 

Report/Doc. number: RA-2036/05, including trials no. R 2005 0161/7, R 2005 0162/5 

M-273708-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

During 2004 and 2005 10 supervised residue trials on grapes were performed according to the intended 

GAP in Southern Europe (Italy, Greece, Spain and S/France). The studies were carried out using oil based 

dispersion concentrate formulations, containing 150 g/L and 100 g/L of spirotetramat and one study was

conducted with a suspension concentrate with 48 g spirotetramat/L. For northern Europe, no trials were

performed. 

The product was used two times with an application rate of 0.096 kg a.s./ha. To cover the different 

agricultural practices of different European countries spray applications were conducted using a water

volume of 160 to 1500 L water/ha. An overview on the supervised residue trials is given in Table B.7.6.5.1-2. 

Table B.7.6.5.1-2: Overview on supervised residue trials with spirotetramat in grapes 

Study no. Region Formula

tion 

No. of 

trials Year Use rate (g as/ha) 

Water 

volume 

(L/ha)

No of 

appl. 

Spray 

interval 

(days)

PHI 

days

RA-2049/04 S-EU OD 100 6 2004 96 1500 2 14 14 

RA-2034/05 S-EU OD 150 2 2005 96 800, 1000 2 14 14 

RA-2036/05 S-EU SC 048 2 2005 96 160, 1000 2 14 14 

The second application was carried out at BBCH growth stage 75-85. 

The samples were taken before the last application, 0, 7, 14, 21 and 28 days after the last application. 

After the harvest the samples were frozen within a maximum of 24 hours after sampling and stored at – 18°C 

until analysis. 

Samples bunch of grapes were taken before the last application, 0, 3, 7, 14 and 21 days after the last

application. The samples of the berries of grapes were taken at 7, 14 and 21 days after application. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 47 to 249 days. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc in the berries and bunch of the grapes were determined by HPLC-ESIMS/MS according to method 00857. 
- 73 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on grapes (bunch and berries), calculated as 

spirotetramat equivalent. 

The mean procedural recoveries at the fortification levels of 0.01 to 2.0 mg/kg for spirotetramat and its four 

metabolites ranged between 85 and 104% and RSD < 20%; these results indicate that the methods used 

were suitable for this analysis. 

Findings:

A detailed summary of the residue trial for citrus fruits is given in Annex I g. 

The total residue of spirotetramat in bunch of grapes ranged between 0.118 and 0.537 mg/kg (STMR 0.266

mg/kg). The total residue in berries ranged between 0.167 to 0.641 mg/kg (STMR 0.272 mg/kg) and did not 

differ significantly from the residue in bunch of grapes. 

There was no difference in residues after spraying of different water rates per ha. Moreover an influence of 

different formulations of spirotetramat (OD100, OD150 of SC048) was not detected. 

Major component of the total residue of spirotetramat in bunch of grapes and berries from all trials sampled 

at the PHI of 14 days after two spray applications was the parent compound. In many trials the enol 

metabolite was detected at similar amounts. BYI08330-ketohydroxy and enol-glucoside were minor 

metabolites, BYI08330-monohydroxy was not detected or in traces, only. 

An overview of the European residue data for spirotetramat and its metabolites is given in the table below. 

Table B.7.6.5.1-3: Overview of European residue data for spirotetramat and its metabolites in grapes 

used 2 times with application rates of 0.096 kg a.s./ha (residues are calculated as spirotetramat 

equivalent): 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Southern Europe 

grape / OD 

100

Bologna, 

Italy, 2004 

bunch 

bunch 

bunch 

bunch 

berry 

bunch 

berry 

bunch 

berry 

0* 

0 

3 

7 

7 

14 

14 

21 

21 

0.03 

0.37 

0.14 

0.15 

0.14 

0.17 

0.12 

0.12 

0.08 

0.040 

0.10 

0.11 

0.17 

0.15 

0.095 

0.092 

0.059 

0.041 

0.060 

0.078 

0.047 

0.095 

0.085 

0.10 

0.072 

0.074 

0.060 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.041 

0.042 

0.031 

0.11 

0.10 

0.16 

0.18 

0.16 

0.16 

0.183 

0.602 

0.340 

0.537 

0.487 

0.537 

0.476 

0.425 

0.353 

grape / OD 

100

San 

Prospero, 

Italy, 2004 

bunch 

bunch 

bunch 

berry 

bunch 

berry 

bunch 

berry 

0* 

0 

7 

7 

14 

14 

21 

21 

0.14 

0.20 

0.20 

0.17 

0.03 

0.06 

0.03 

0.03 

0.030 

0.042 

0.045 

0.037 

0.022 

0.035 

0.022 

0.022 

0.025 

0.027 

0.045 

0.031 

0.020 

0.038 

0.024 

0.020 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.020 

0.018 

0.026 

0.026 

0.019 

0.038 

0.030 

0.030 

0.227 

0.299 

0.328 

0.276 

0.103 

0.183 

0.118 

0.114 
- 74 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

table grape 

/ OD 100

Korinthos, 

Greece, 

2004 

bunch 

berry 

bunch 

berry 

bunch 

berry 

bunch 

berry 

bunch 

berry 

bunch 

berry 

0* 

0* 

0 

0 

3 

3 

7 

7 

14 

14 

21 

21 

0.05 

0.05 

0.17 

0.14 

0.15 

0.12 

0.15 

0.16 

0.08 

0.08 

0.10 

0.08 

0.064 

0.066 

0.092 

0.089 

0.096 

0.081 

0.11 

0.11 

0.11 

0.11 

0.11 

0.11 

0.012 

0.012 

0.015 

0.012 

0.015 

0.013 

0.018 

0.018 

0.012 

0.013 

0.016 

0.014 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.022 

0.023 

0.023 

0.025 

0.027 

0.025 

0.033 

0.037 

0.043 

0.045 

0.054 

0.051 

0.16 

0.163 

0.312 

0.278 

0.300 

0.251 

0.323 

0.337 

0.257 

0.260 

0.292 

0.267 

table grape 

/ OD 100

Cieza, 

Spain, 2004 

bunch 

berry 

bunch 

berry 

bunch 

berry 

bunch 

berry 

bunch 

berry 

bunch 

berry 

0* 

0* 

0 

0 

3 

3 

7 

7 

15 

15 

21 

21 

0.22 

0.22 

0.32 

0.52 

0.45 

0.49 

0.37 

0.30 

0.20 

0.47 

0.21 

0.33 

0.030 

0.031 

0.035 

0.050 

0.044 

0.040 

0.039 

0.027 

0.021 

0.047 

0.018 

0.031 

0.033 

0.032 

0.022 

0.034 

0.049 

0.050 

0.040 

0.025 

0.024 

0.054 

0.021 

0.035 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.028 

0.028 

0.017 

0.027 

0.033 

0.031 

0.029 

0.022 

0.027 

0.058 

0.030 

0.054 

0.323 

0.323 

0.406 

0.643 

0.588 

0.623 

0.490 

0.386 

0.284 

0.641 

0.291 

0.462 

table grape 

/ OD 100

Vacquiers, 

S-France, 

2004 

bunch 

berry 

bunch 

berry 

bunch 

berry 

bunch 

berry 

bunch 

berry 

0* 

0* 

0 

0 

7 

7 

14 

14 

21 

21 

0.07 

0.06 

0.19 

0.18 

0.10 

0.09 

0.11 

0.13 

0.09 

0.09 

0.033 

0.030 

0.041 

0.034 

0.037 

0.032 

0.044 

0.055 

0.040 

0.038 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

<0.012 

<0.012 

0.023 

0.020 

0.024 

0.024 

0.032 

0.033 

0.063 

0.074 

0.062 

0.063 

0.15 

0.134 

0.279 

0.262 

0.193 

0.179 

0.241 

0.283 

0.216 

0.215 

table grape 

/ OD 100

Anchialos, 

Greece, 

2004 

bunch 

berry 

bunch 

berry 

bunch 

berry 

bunch 

berry 

bunch 

berry 

0* 

0* 

0 

0 

7 

7 

14 

14 

21 

21 

0.03 

0.10 

0.14 

0.09 

0.15 

0.11 

0.05 

0.15 

0.05 

0.02 

0.024 

0.043 

0.023 

0.043 

0.057 

0.045 

0.042 

0.022 

0.034 

0.022 

0.012 

0.020 

0.012 

0.017 

0.018 

0.014 

0.012 

0.012 

0.013 

0.012 

<0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.028 

0.093 

0.027 

0.082 

0.060 

0.036 

0.040 

0.022 

0.043 

0.031 

0.106 

0.268 

0.214 

0.244 

0.297 

0.217 

0.156 

0.218 

0.152 

0.097 

grape / OD 

150 

Campo 

Arcis, 

Spain, 2005 

bunch 

bunch 

bunch 

bunch 

berry 

bunch 

berry 

bunch 

berry 

0* 

0 

3 

7 

7 

14 

14 

21 

21 

0.09 

0.39 

0.32 

0.09 

0.11 

0.09 

0.07 

0.07 

0.06 

0.029 

0.038 

0.030 

0.030 

0.034 

0.027 

0.031 

0.022 

0.024 

0.013 

<0.012 

0.014 

0.017 

0.014 

0.019 

0.019 

0.018 

0.019 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.015 

0.011 

0.013 

0.017 

0.022 

0.031 

0.035 

0.029 

0.030 

0.159 

0.463 

0.389 

0.166 

0.192 

0.179 

0.167 

0.151 

0.145 
- 75 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

grape / OD 

150

Bologna, 

Italy, 2005 

bunch 

bunch 

bunch 

bunch 

berry 

bunch 

berry 

bunch 

berry 

0* 

0 

3 

7 

7 

14 

14 

21 

21 

0.14 

0.34 

0.19 

0.11 

0.19 

0.13 

0.16 

0.05 

0.03 

0.062 

0.057 

0.12 

0.22 

0.20 

0.17 

0.21 

0.14 

0.12 

0.027 

0.022 

0.026 

0.028 

0.040 

0.035 

0.041 

0.034 

0.029 

<0.012 

<0.012 

<0.012 

0.014 

0.016 

<0.012 

<0.012 

0.014 

<0.012 

0.040 

0.036 

0.039 

0.082 

0.11 

0.13 

0.15 

0.15 

0.15 

0.281 

0.467 

0.387 

0.454 

0.556 

0.477 

0.573 

0.388 

0.341 

grape / 048 

SC 

Vendeuvre 

du Poitou, 

S-France, 

2005 

bunch 

bunch 

berry 

bunch 

berry 

bunch 

berry 

0 

7 

7 

14 

14 

21 

21 

0.21 

0.20 

0.14 

0.17 

0.16 

0.14 

0.12 

<0.012 

0.012 

<0.012 

0.015 

<0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

0.009 

0.011 

0.008 

0.015 

0.017 

0.254 

0.244 

0.185 

0.22 

0.204 

0.191 

0.173 

grape / 048 

SC 

Bologna, 

Italy, 2005 

bunch 

bunch 

berry 

bunch 

berry 

bunch 

berry 

0 

7 

7 

14 

14 

21 

21 

0.11 

0.08 

0.08 

0.10 

0.07 

0.03 

0.03 

0.027 

0.13 

0.14 

0.14 

0.15 

0.099 

0.10 

<0.012 

0.019 

0.015 

0.026 

0.021 

0.018 

0.018 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.014 

0.052 

0.063 

0.084 

0.095 

0.11 

0.11 

0.175 

0.293 

0.31 

0.362 

0.348 

0.269 

0.270 

Residues in berries were used for the estimation of the dietary risk and for MRL setting. 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used for 

spirotetramat in grapes (based on data obtained from trials from Southern Europe): 

MRL-calculation based on data obtained from the Southern Region:

Individual data points for grapes are: 

0.167 mg/kg, 0.183 mg/kg, 0.204 mg/kg, 0.218 mg/kg, 0.26 mg/kg, 0.283 mg/kg, 0.348 mg/kg, 0.476 mg/kg,

0.573 mg/kg, 0.641 mg/kg 

Mean residue: 0.335 mg/kg; standard deviation: 0.017 mg/kg 

STMR: 0.272 mg/kg 

Highest residue: 0.641 mg/kg 

Method I: Rmax = 0.831 mg/kg 

Method II: Rber = 1.001 mg/kg 

Based on the data available for grapes, a MRL of 1 mg/kg can be proposed. 

Conclusion:

During 2004 and 2005 altogether 10 residue trials were carried out on grapes in Southern Europe according 

to the intended GAP. The trials were conducted using BYI 08330 OD 100, BYI 08330 OD 150 and BYI 08330 

048 SC as formulations. The residues in grapes were comparable and resulted in a MRL of 1 mg/kg of 

spirotetramat and its metabolites. The highest residue in S-EU reached 0.641 mg/kg. 

No residue trials for Northern Europe were submitted. Therefore the evaluation of the residue situation in 

grapes is limited to South-Europe and the MRL is based on S-EU data only. 

Comments (RMS):

No comments. 

B.7.6.5.2 Strawberry 

Spirotetramat is applied for control of aphids and white flies in strawberries. The critical European GAP for 

the use in northern (N-EU) and southern Europe (S-EU) is summarized in Table B.7.6.5.2-1. 
- 76 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.5.2-1: GAP for residue situation in strawberries 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 2 Spray BBCH 87 0.096 g a.s./ha 3 

EU-S F 2 Spray BBCH 87 0.096 g a.s./ha 3 

EU-N/S G 2 Spray BBCH 87 0.096 g a.s./ha 3 

Reference: Determination of the Residues of BYI08330 in/on Strawberry after Spraying 

of BYI08330 (100 OD) in the Greenhouse in Germany and France 

Author(s), year: Freitag T.; Eberhardt R.; 2006 

Report/Doc. number: RA-2122/04, including trials no. R 2004 0726/2, R 2004 0765/3, R 2004 0766/1, R 

2004 0768/8, R 2004 0769/6, R 2004 0771/8, R 2004 0772/6, R 2004 0773/4 

M-263736-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Strawberry after Spraying 

of BYI08330 (100 OD) in the Field in Germany and Northern France 

Author(s), year: Freitag T.; Helfrich P.; 2006 ; amended 18.01.2006 

Report/Doc. number: RA-2120/04, 

including trials no. R 2004 0724/6, R 2004 0759/9, R 2004 0760/2, R 2004 0761/0 

M-262423-02-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Strawberry after Spraying 

of BYI08330 (100 OD) in the Field in Italy, Spain and Southern France 

Author(s), year: Freitag T.; Helfrich P.; 2006 

Report/Doc. number: RA-2121/04, including trials no. R 2004 0725/4, R 2004 0762/9, R 2004 0763/7, R 

2004 0764/5 

M-262418-02-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

The magnitude of residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 

08330-mono-hydroxy and BYI 08330-enol-Glc in/on strawberries harvested following the treatment with BYI 

08330 100 OD formulation in greenhouse (Germany and France,) and under field conditions (N-EU: 

Germany and N-France; S-EU: Italy, Spain and S-France) was determined. 

Overall 16 residue trials on strawberry were conducted in 2004. An overview on the supervised residue trials 

conducted with BYI 08330 100 OD formulation is given in Table B.7.6.5.2-2 
- 77 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.5.2-2: Overview on European residue trials with BYI08330 in strawberry 

Location Formulation No. of 

trials Year Use rate (g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Greenhouse OD 100 8 2004 96 600-1000 2 14 

Field N-EU OD 100 4 2004 96 600-1000 2 14 

Field S-EU OD 100 4 2004 96 600-800 2 14 

All trials were applied according to the intended European GAP. The last application was carried out at 

growth stage BBCH 81 - 89. The specimens were taken before the last treatment, 0, 1, 3 and 7 and 14-15

days after the last application. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 107 to 365 days. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc in strawberries were determined by HPLC-ESI-MS/MS according to method 

00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on strawberries, calculated as spirotetramat equivalent. 

The mean procedural recoveries at the fortification levels of 0.01 to 1.0 mg/kg for spirotetramat and its four 

metabolites ranged between 91 and 96% and RSD < 20%; these results indicate that the methods used were

suitable for this analysis. 

Findings:

A detailed summary of the residue results is given in Appendix I h. 

The total residue of spirotetramat in strawberries grown in the greenhouse according to the European GAP 

ranged between 0.205 and 0.328 mg/kg. In strawberry fruit from 4 field trials in northern Europe a total 

residue of 0.162 to 0.258 mg/kg was detected, in strawberry fruit from 4 field trials in southern Europe a total 

residue of 0.113 to 0.152 mg/kg was measured. The results indicated that the residue level in strawberries 

grown in greenhouse is higher than in the field trials. Therefore, for estimation of the dietary risk and for MRL 

setting the residue results from the 8 greenhouse residue trials were taken in consideration. 

The residue data used for the evaluation are marked in bold. 

Major component of the total residue of spirotetramat in strawberries from all trials collected at the PHI of 3 

days was BYI08330-enol. The parent compound, the ketohydroxy and the enol-glucoside were minor 

components. BYI08330-monohydroxy was not found or in traces, only. 

Table B.7.6.5.2-3: Overview of European residue data for spirotetramat and its metabolites in 

strawberry used 2-3 times with application rates of 0.076 kg a.s./ha (residues are calculated as 

spirotetramat equivalent): 

crop 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Greenhouse trials 

strawberry Bocholt, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

14 

0.01 

0.04 

0.03 

0.01 

0.01 

0.01 

0.13 

0.16 

0.19 

0.19 

0.24 

0.18 

0.012 

0.014 

0.013 

0.012 

0.012 

0.015 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.011 

0.172 

0.234 

0.253 

0.232 

0.282 

0.228 
- 78 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

strawberry Bocholt, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

14 

0.01 

0.04 

0.01 

0.01 

0.01 

0.01 

0.16 

0.22 

0.13 

0.16 

0.15 

0.14 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.018 

0.022 

0.014 

0.011 

0.010 

0.019 

0.212 

0.306 

0.178 

0.205 

0.194 

0.193 

strawberry BornheimSechtem, 

Germany 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

14 

0.01 

0.08 

0.06 

0.04 

0.03 

0.02 

0.062 

0.11 

0.15 

0.16 

0.16 

0.071 

0.012 

0.013 

0.014 

0.014 

0.016 

0.014 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.012 

0.008 

0.009 

0.009 

0.013 

0.026 

0.030 

0.104 

0.224 

0.245 

0.239 

0.244 

0.147 

strawberry Reynies, 

France, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

14 

0.01 

0.04 

0.02 

0.02 

0.01 

0.01 

0.12 

0.14 

0.14 

0.22 

0.28 

0.27 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.008 

0.008 

0.008 

0.013 

0.014 

0.021 

0.162 

0.212 

0.192 

0.277 

0.328 

0.325 

strawberry TelgteWestbevern, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

0.03 

0.12 

0.04 

0.03 

0.05 

0.11 

0.16 

0.16 

0.11 

0.21 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.172 

0.312 

0.232 

0.172 

0.292 

strawberry TelgteWestbevern, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

0.02 

0.11 

0.06 

0.04 

0.03 

0.075 

0.14 

0.18 

0.16 

0.13 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.009 

0.009 

0.010 

0.009 

0.127 

0.283 

0.273 

0.234 

0.193 

strawberry VechtaLangförden, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

0.04 

0.13 

0.11 

0.08 

0.08 

0.15 

0.18 

0.21 

0.17 

0.14 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.222 

0.342 

0.352 

0.282 

0.252 

strawberry Carpentras, 

France, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

0.01 

0.03 

0.02 

0.02 

0.02 

0.18 

0.22 

0.23 

0.25 

0.21 

0.012 

0.013 

0.013 

0.013 

0.013 

0.012 

0.012 

0.012 

0.012 

0.012 

0.008 

0.008 

0.008 

0.008 

0.009 

0.222 

0.283 

0.283 

0.303 

0.264 

Field trial – Northern Europe 

strawberry Bocholt, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

14 

0.01 

0.01 

0.01 

0.01 

0.01 

<0.01 

0.14 

0.064 

0.084 

0.12 

0.14 

0.060 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.008 

0.182 

0.106 

0.126 

0.162 

0.182 

0.102 

strawberry TelgteWestbevern, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

14 

<0.01 

0.02 

0.01 

0.01 

0.01 

<0.01 

0.039 

0.033 

0.050 

0.088 

0.12 

0.049 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.008 

0.081 

0.085 

0.092 

0.130 

0.162 

0.091 

strawberry Cremery, NFrance, 2004 fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

14 

0.01 

0.05 

0.02 

0.02 

0.01 

0.01 

0.083 

0.11 

0.16 

0.20 

0.19 

0.14 

0.012 

0.012 

0.012 

0.012 

0.014 

0.019 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.013 

0.014 

0.016 

0.014 

0.025 

0.033 

0.130 

0.198 

0.220 

0.258 

0.251 

0.214 
- 79 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

strawberry Glisolles, NFrance, 2004 fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

14 

<0.01 

0.14 

0.08 

0.07 

0.02 

0.01 

<0.012 

0.086 

0.078 

0.11 

0.12 

0.060 

<0.012 

<0.012 

<0.012 

0.012 

0.012 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

0.008 

0.008 

0.008 

0.009 

0.012 

0.054 

0.258 

0.19 

0.212 

0.173 

0.107 

Field trials – Southern Europe 

strawberry San Martino, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

14 

<0.01 

0.04 

0.02 

0.02 

0.01 

<0.01 

<0.012 

0.020 

0.050 

0.080 

0.075 

0.029 

<0.012 

<0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

<0.012 

<0.008 

<0.008 

0.008 

0.012 

0.034 

0.020 

0.054 

0.092 

0.102 

0.136 

0.143 

0.083 

strawberry Imola, Italy, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

14 

<0.01 

0.05 

0.02 

0.01 

<0.01 

0.01 

0.037 

0.070 

0.080 

0.11 

0.066 

0.042 

0.012 

0.015 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

0.008 

<0.008 

0.008 

0.008 

0.014 

0.079 

0.155 

0.132 

0.152 

0.108 

0.09 

strawberry Sant Cebrià 

de Vallalta, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

0.01 

0.03 

0.03 

0.02 

0.01 

0.021 

0.060 

0.089 

0.090 

0.069 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.009 

0.063 

0.122 

0.151 

0.143 

0.114 

strawberry Courzieu, SFrance, 2004 fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

7 

15 

0.01 

0.10 

0.06 

0.02 

0.01 

0.02 

0.052 

0.058 

0.049 

0.061 

0.019 

0.012 

0.012 

0.015 

0.015 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.011 

0.011 

0.012 

0.008 

0.008 

0.008 

0.097 

0.197 

0.144 

0.113 

0.061 

0.054 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used 

spirotetramat in strawberries (based on data obtained from trials from Northern and Southern Europe and 

glasshouse): 

MRL-calculation based on data obtained from the Northern Region:

Individual data points for strawberry are: 

0.162 mg/kg, 0.182 mg/kg, 0.212 mg/kg, 0.258 mg/kg 

Mean residue: 0.204 mg/kg; standard deviation: 0.042 mg/kg 

STMR: 0.197 mg/kg 

Highest residue: 0.258 mg/kg 

Method I: Rmax = 0.418 mg/kg 

Method II: Rber = 0.493 mg/kg 

Based on the data available for strawberry in Northern Europe, a MRL of 0.5 mg/kg can be proposed. 

MRL-calculation based on data obtained from the Southern Region:

Individual data points for strawberry are: 

0.113 mg/kg, 0.143 mg/kg, 0.143 mg/kg, 0.152 mg/kg 

Mean residue: 0.138 mg/kg; standard deviation: 0.017 mg/kg 

STMR: 0.143 mg/kg 

Highest residue: 0.152 mg/kg 

Method I: Rmax = 0.225 mg/kg 
- 80 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Method II: Rber = 0.300 mg/kg 

Based on the data available for strawberry in Southern Europe, a MRL of 0.5 mg/kg can be proposed. 

MRL-calculation based on data obtained from the greenhouse trials:

Individual data points for strawberry are: 

0.205 mg/kg, 0.234 mg/kg, 0.244 mg/kg, 0.282 mg/kg, 0.282 mg/kg, 0.292 mg/kg, 0.303 mg/kg, 0.328 mg/kg 

Mean residue: 0.271 mg/kg; standard deviation: 0.040 

STMR: 0.282 mg/kg 

Highest residue: 0.328 mg/kg 

Method I: Rmax = 0.500 mg/kg 

Method II: Rber = 0.601 mg/kg 

Based on the data available for strawberry in greenhouse, a MRL of 1 mg/kg can be proposed. 

Conclusion:

In 2004, altogether 16 residue trials (field and glasshouse) in Northern and Southern Europe were carried 

out. All trials were carried out according the intended use parameters and were performed as residue decline 

studies. The critical trials with highest residues levels were represented by the trials on protected crops. 

Outdoor studies showed lower residue levels which were 0.162 and 0.258 mg/kg in the four trials of the

North and ranged between 0.113 and 0.152 mg/kg in the Southern European trials. Therefore the 8 the 

greenhouse trials from Europe were taken for MRL calculation. Based on these trials a MRL of 1 mg/kg can 

be proposed. 

Comments (RMS):

All residue trials were performed only in one season. But as the the highest residues were determined in the 

glasshouse trials the weather conditions in different saisons should not influence the outcome of the residue 

trials. 

B.7.6.6 Bulb vegetable 

B.7.6.6.1 Onion 

Spirotetramat is applied for control Thrips tabacchi in onion. The critical European GAP for the use in 

northern (S-EU) and southern Europe (S-EU) is summarized in Table B.7.6.6.1-1 

Table B.7.6.6.1-1: GAP for residue situation in onion 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 4 Spray BBCH 82 0.072 g a.s./ha 7 

Reference: Determination of the residues of BYI08330 in/on onion after spraying of 

BYI08330 (100 OD) in the field in Germany and Northern France 

Author(s), year: Cavaille C.; 2005 

Report/Doc. number: RA-2131/04, including trials no. R 2004 0854/4, R 2004 0855/2, R 2004 0856/0, R 

2004 0857/9 

M-259115-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 
- 81 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of the residues of BYI08330 in/on onion after spraying of 

BYI08330 (150 OD) in the field in United Kingdom, Northern France and 

Germany 

Author(s), year: Ballesteros C.; Gateaud L.; 2006 

Report/Doc. number: RA-2040/05, including trials no. R 2005 0212/5, R 2005 0214/1, R 2005 0216/8, R 

2005 0217/6 

M-269474-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on onion after spraying of 

BYI08330 (100 OD) in the field in Southern France, Greece, Italy and Spain 

Author(s), year: Cavaille C.; 2005 

Report/Doc. number: RA-2132/04, including trials no. R 2004 0858/7, R 2004 0859/5, R 2004 0860/9, R 

2004 0861/7 

M-259663-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on onion after spraying of 

BYI08330 (150 OD) in the field in Italy, Spain and Southern France 

Author(s), year: Ballesteros C.; Gateaud L.; 2006 

Report/Doc. number: RA-2041/05, including trials no. R 2005 0225/7, R 2005 0226/5, R 2005 0227/3, R 

2005 0228/1 

M-269869-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

During 2004 and 2005, 8 residue trials for each European region were conducted. All studies were carried 

out using oil based dispersion concentrates containing 150 g/L and 100 g/L of spirotetramat respectively. 

The product was used four times, using an application rate of 0.072 kg a.s./ha. All trials were performed 

according to the critical European GAP. 

An overview on the supervised residue trials is given in Table B.7.6.6.1-2. 

Table B.7.6.6.1-2: Overview on supervised residue trials with BYI08330 on onion 

Study no. Region Formulation 

No. of 

trials Year Use rate 

(g as/ha) 

Water 

volume 

(L/ha) 

No of 

appl. 

Spray 

interval 

(days) 

PHI 

days 

RA-2131/04 N-EU OD 100 4 2004 72 400-600 4 7 7-21 

RA-2040/05 N-EU OD150 4 2005 72 300/400 4 6-8 7-21 

RA-2132/04 S-EU OD 100 4 2004 72 400-600 4 6-8 7-21 

RA-2041/05 S-EU OD150 4 2005 72-78 500-646 4 6-9 7-21
- 82 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The last application was carried out at BBCH growth stage 47-48. Specimens of onion pulps were taken 

before the last treatment, 0, 3, 7, 14 and 21 days after the last application. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 344 to 479 days for the trials carried out in 2004 and 84-

225 days for the residue trials from 2005. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc in onion were determined by HPLC-ESI-MS/MS according to method 

00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on onion, all metabolites calculated as spirotetramat 

equivalent. 

The mean procedural recoveries at the fortification levels of 0.01 to 1.0 mg/kg for spirotetramat and its four 

metabolites ranged between 78 and 100%. 

Findings:

A detailed summary of the residue results is given in Appendix I i. 

The total residue of spirotetramat in onion bulbs from 8 field trials in northern Europe ranged between <0.054 

to 0.202 mg/kg. From the 8 field trials carried out in southern Europe, the total residues of <0.054 -

0.172 mg/kg were detected. The residue data used for the evaluation are marked in bold. There was no 

difference of residues in onion bulbs grown in northern or southern Europe. 

Major component of the total residue of BYI08330 in onion was BYI08330-enol. 

Table B.7.6.6.1-3: Overview of European residue data for spirotetramat and its metabolites in onion 

used 4 times with application rates of 0.076 kg a.s./ha (residues are calculated as spirotetramat 

equivalent): 

crop / 

formulatio

n 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Field trials – Northern Europe 

Onion / 

100 OD 

Langenfeld, 

Germany, 

2004 

bulb 

bulb 

bulb 

bulb 

0 

7 

14 

21 

0.04 

<0.01 

<0.01 

<0.01 

0.16 

0.16 

0.051 

0.060 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

0.232 

0.202 

0.093 

0.102 

Onion / 

100 OD 

Champien, 

France, 2004 

bulb 

bulb 

bulb 

bulb 

0 

7 

14 

21 

0.03 

<0.01 

<0.01 

<0.01 

0.061 

0.055 

0.045 

0.052 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

0.123 

0.097 

0.087 

0.094 

Onion / 

100 OD 

Brüggen, 

Germany, 

2004 

bulb 

bulb 

bulb 

bulb 

bulb 

bulb 

0 

0 

4 

7 

14 

21 

0.01 

0.04 

0.02 

<0.01 

<0.01 

<0.01 

0.061 

0.063 

0.066 

0.055 

0.066 

0.067 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.103 

0.135 

0.118 

0.097 

0.108 

0.109 

Onion / 

100 OD 

Epone, 

France, 2004 

bulb 

bulb 

bulb 

bulb 

bulb 

bulb 

0 

0 

3 

7 

14 

21 

<0.01 

0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.047 

0.052 

0.052 

0.071 

0.058 

0.052 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.089 

0.094 

0.094 

0.113 

0.100 

0.094 

Onion / 

150 OD 

thetford, 

UK, 2005 

bulb 

bulb 

0 

8 

0.01 

<0.01 

0.11 

0.12 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

0.152 

0.162 

Onion / 

150 OD 

Champien, 

France, 2005 

bulb 

bulb 

0 

7 

0.02 

0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

0.064 

<0.054 
- 83 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulatio

n 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Onion / 

150 OD 

LangenfeldRS-EUrath, 

Germany, 

2005 

bulb 

bulb 

bulb 

bulb 

bulb 

bulb 

0 

0 

3 

7 

14 

21 

<0.01 

0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.042 

0.043 

0.042 

0.042 

0.041 

0.038 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.084 

0.085 

0.084 

0.084 

0.083 

0.080 

Onion / 

150 OD 

Bornheim, 

Germany, 

2005 

bulb 

bulb 

bulb 

bulb 

bulb 

bulb 

0 

0 

3 

7 

15 

21 

<0.01 

0.04 

0.01 

<0.01 

<0.01 

<0.01 

0.020 

0.038 

0.040 

0.050 

0.040 

0.031 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.062 

0.110 

0.082 

0.092 

0.082 

0.073 

Field trials – Southern Europe 

Onion / 

100 OD 

Chazay 

d'Azergues, 

France, 2004 

bulb 

bulb 

bulb 

bulb 

0 

7 

14 

21 

<0.01 

<0.01 

<0.01 

<0.01 

0.040 

0.021 

0.024 

0.022 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

0.082 

0.063 

0.066 

0.064 

Onion / 

100 OD 

Thiva, 

Greece, 

2004 

bulb 

bulb 

bulb 

bulb 

0 

7 

14 

21 

<0.01 

<0.01 

<0.01 

<0.01 

0.064 

0.081 

0.061 

0.055 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

0.106 

0.123 

0.103 

0.097 

Onion / 

100 OD 

Bologna, 

Italy, 2004 

bulb 

bulb 

bulb 

bulb 

bulb 

bulb 

0 

0 

3 

7 

14 

21 

0.02 

0.02 

<0.01 

<0.01 

<0.01 

<0.01 

0.042 

0.038 

0.050 

0.052 

0.052 

0.056 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.094 

0.090 

0.092 

0.094 

0.094 

0.098 

Onion / 

100 OD 

Alginet, 

Spain, 2004 

bulb 

bulb 

bulb 

bulb 

bulb 

bulb 

0 

0 

3 

7 

14 

21 

<0.01 

0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.090 

0.083 

0.11 

0.13 

0.12 

0.11 

<0.012 

<0.012 

<0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.132 

0.125 

0.152 

0.172 

0.162 

0.152 

Onion / 

150 OD 

Settepolesini, 

Italy, 2005 

bulb 

bulb 

0 

7 

<0.01 

<0.01 

0.030 

0.034 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

0.072 

0.076 

Onion / 

150 OD 

Malgrat de 

Mar, 

Spain, 2005 

bulb 

bulb 

0 

7 

0.02 

0.02 

0.032 

0.037 

<0.012 

0.017 

<0.012 

<0.012 

<0.008 

<0.008 

0.084 

0.094 

Onion / 

150 OD 

Saint Jory , 

France, 2005 

bulb 

bulb 

bulb 

bulb 

bulb 

bulb 

0 

0 

3 

7 

14 

21 

<0.01 

0.01 

0.01 

<0.01 

<0.01 

<0.01 

0.037 

0.051 

0.14 

0.10 

0.050 

0.034 

<0.012 

0.015 

<0.012 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.079 

0.096 

0.182 

0.143 

0.092 

0.076 

Onion / 

150 OD 

Alginet, 

Spain, 2005 

bulb 

bulb 

bulb 

bulb 

bulb 

bulb 

0 

0 

3 

7 

14 

21 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used 

spirotetramat in onion (based on data obtained from trials from Northern and Southern Europe): 
- 84 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

MRL-calculation based on data obtained from the Northern Region:

Individual data points for onion are: 

<0.054, 0.084, 0.092, 0.097, 0.109, 0.113, 0.162, 0.202 mg/kg 

Mean residue: 0.114 mg/kg; standard deviation: 0.047 mg/kg 

STMR: 0.103 mg/kg 

Highest residue: 0.202 mg/kg 

Method I: Rmax = 0.263 mg/kg 

Method II: Rber = 0.300 mg/kg 

Based on the data available for onion in Northern Europe, a MRL of 0.3 mg/kg can be proposed. 

MRL-calculation based on data obtained from the Southern Region:

Individual data points for onion are: 

<0.054, 0.066, 0.076, 0.094, 0.098, 0.123, 0.143, 0.172 mg/kg 

Mean residue: 0.103 mg/kg; standard deviation: 0.040 mg/kg 

STMR: 0.096 mg/kg 

Highest residue: 0.172 mg/kg 

Method I: Rmax = 0.232 mg/kg 

Method II: Rber = 0.276 mg/kg 

Based on the data available for onion in Southern Europe, a MRL of 0.3 mg/kg can be proposed. 

Conclusion:

In 2004 and 2005, altogether 16 residue trials in Northern and Southern Europe were carried out. Al trials 

were carried out according the intended use parameters. All residue trials were performed as residue decline 

studies. There was no difference of residues in onion bulbs grown in northern or southern Europe. Based on 

the submitted supervised residue trials a MRL of 0.3 mg/kg can be proposed. 

Comments (RMS):

No comments. 

B.7.6.7 Fruiting vegetables 

B.7.6.7.1 Tomato 

Spirotetramat is applied the use in tomatoes against whiteflies, aphids, and mites. The critical European 

GAPs in the greenhouse and in the field use in southern Europe (S-EU) are summarized in Table B.7.6.7.1-

1. 

Table B.7.6.7.1-1: GAP for residue situation in tomatoes 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-S F 4 Spray BBCH 87 0.072 g a.s./ha 3 

EU-N/S G 4 Spray BBCH 87 0.072 kg a.s./ha and m leafy 

surface, max. 0.144 kg 

a.s./ha 

3 
- 85 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of the Residues of BYI08330 in/on Cherry Tomato After 

Spraying of BYI08330 (100 OD) in the Greenhouse in Italy and Spain 

Author(s), year: Freitag T.; Helfrich P.; 2006 

Report/Doc. number: RA-2139/04, including trials no. R 2004 0823/4, R 2004 0824/2, R 2004 0825/0, R 

2004 0826/9 

M-264462-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Tomato after Spraying of 

BYI08330 (100 OD) in the Greenhouse in Greece, Spain and Italy 

Author(s), year: Freitag T.; Helfrich P.; 2005 

Report/Doc. number: RA-2140/04, including trials no. R 2004 0827/7, R 2004 0828/5, R 2004 0829/3, R 

2004 0830/7 

M-263523-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Tomato after Spraying of 

BYI08330 (100 OD) in the Field in Spain, Portugal, Greece and Italy 

Author(s), year: Freitag T.; Helfrich P.; 2006 

Report/Doc. number: RA-2130/04, including trials no. R 2004 0849/8, R 2004 0850/1, R 2004 0852/8, R 

2004 0853/6 

M-263566-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

The magnitude of residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 

08330-mono-hydroxy and BYI 08330-enol-Glc in tomatoes harvested following four applications with the 

formulation BYI 08330 100 OD in Southern Europe (4 trials: Italy, Greece, Spain and Portugal) and trials in 

greenhouses (8 trials) was determined. All trials were carried out in 2004. 

The used formulation was the oil based dispersion concentrates containing 100 g/L spirotetramat. For the 

greenhouse applications, the product was used four times at application rates of 0.072 kg a.s./ha and meter 

leafy surface and a water volume of 750 – 1000 L per ha and meter leafy surface (1.45 – 2.2 m), this is 

corresponding to 0.104 – 0.166 kg a.s./ha. An overview on the supervised residue trials conducted with BYI 

08330 100 OD formulation is given in Table B.7.6.5.2-2 

Table B.7.6.7.1-2: Overview on European residue trials with BYI08330 in tomatoes 

Location Formulation No. of 

trials Year Use rate (g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Greenhouse OD 100 4 2004 108-166* 1600-1760 4 6-7 
- 86 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Location Formulation No. of 

trials Year Use rate (g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Greenhouse OD 100 4 2004 108-144* 1125-1600 4 6-7 

Field S-EU OD 100 4 2004 72 750 4 6-9 

* corresponding to 72 g a.s./ha per meter leafy surface 

The last applications were carried out at growth stage between BBCH 72 and BBCH 87. Samples were taken

before the last application, 0, 1, 3, 4-5 and 7-8 days after the last application. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 122 to 265 days. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc were determined by HPLC-ESI-MS/MS according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on tomatoes (all metabolites calculated as spirotetramat 

equivalent). 

The mean procedural recoveries at the fortification levels of 0.01 to 2.0 mg/kg for spirotetramat and its four 

metabolites ranged between 78 and 101 % and RSD < 20%; these results indicate that the methods used 

were suitable for this analysis. 

Findings:

A detailed summary of the residue results is given in Appendix I j. 

The total residue of spirotetramat in tomatoes grown in the greenhouse (8 trials) according to the European 

GAP ranged between 0.215 and 0.736 mg/kg. In tomatoes from 4 field trials in southern Europe a total 

residue of 0.120 to 0.209 mg/kg could be determined. The results indicated that the residue level in tomatoes 

grown in greenhouse is higher than in the field trials. Therefore, for estimation of the dietary risk and for MRL 

setting, the residue results from the 8 greenhouse residue trials were taken in consideration. Generally 

residue data of day 3 after the last application were evaluated according to the PHI of the critical European 

GAP. If the total residue of spirotetramat at longer intervals exceeded the residue of day 3, the higher value 

was evaluated to cover the worst case residue. An overview of the residue data is reported in the table 

below. The residue data used for the evaluation are marked in bold. 

The total residues of spirotetramat in tomato fruits are mainly composed of the parent compound and the 

enol metabolite. BYI08330-ketohydroxy and -enol-glucoside were minor metabolites. BYI08330-

monohydroxy was not found. 

Table B.7.6.7.1-3: Overview of European residue data for spirotetramat and its metabolites in 

tomatoes used 4 times with application rates of 0.076 kg a.s./ha (residues are calculated as 

spirotetramat equivalent); formulation: BYI 08330 100 OD 

crop 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Greenhouse trials 

cherry 

tomato, 

Giovinazzo, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

4 

8 

0.12 

0.25 

0.11 

0.09 

0.11 

0.05 

0.20 

0.21 

0.19 

0.18 

0.17 

0.16 

0.065 

0.056 

0.040 

0.039 

0.050 

0.032 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.080 

0.084 

0.082 

0.096 

0.10 

0.11 

0.477 

0.612 

0.434 

0.417 

0.442 

0.364 

cherry 

tomato 

Molfetta 

(Bari), Italy, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

4 

8 

0.12 

0.19 

0.10 

0.04 

0.16 

0.14 

0.16 

0.14 

0.17 

0.17 

0.16 

0.15 

0.019 

0.019 

0.014 

0.012 

0.022 

0.020 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.065 

0.059 

0.062 

0.061 

0.082 

0.094 

0.376 

0.420 

0.358 

0.295 

0.436 

0.416 
- 87 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

cherry 

tomato 

Jayena 

Granada, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.18 

0.39 

0.24 

0.22 

0.25 

0.25 

0.22 

0.27 

0.23 

0.25 

0.24 

0.21 

0.013 

0.017 

0.016 

0.022 

0.021 

0.024 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.15 

0.17 

0.15 

0.17 

0.18 

0.24 

0.575 

0.859 

0.648 

0.674 

0.703 

0.736 

cherry 

tomato 

Fornes 

Granada, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.23 

0.27 

0.22 

0.25 

0.16 

0.16 

0.22 

0.21 

0.20 

0.23 

0.23 

0.21 

0.044 

0.037 

0.033 

0.045 

0.036 

0.034 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.12 

0.11 

0.12 

0.14 

0.14 

0.19 

0.626 

0.639 

0.585 

0.677 

0.578 

0.606 

Tomato Vasilica, 

Greece, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

8 

0.04 

0.05 

0.04 

0.06 

0.03 

0.03 

0.11 

0.11 

0.19 

0.39 

0.23 

0.18 

0.012 

0.012 

0.012 

0.021 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.026 

0.019 

0.021 

0.031 

0.028 

0.030 

0.200 

0.203 

0.275 

0.514 

0.312 

0.264 

Tomato Palacios 

Sevilla, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

6 

7 

0.09 

0.10 

0.10 

0.09 

0.04 

0.09 

0.077 

0.078 

0.093 

0.10 

0.081 

0.099 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.039 

0.040 

0.042 

0.043 

0.048 

0.078 

0.230 

0.242 

0.259 

0.257 

0.193 

0.291 

Tomato Viladecans, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

4 

7 

0.11 

0.13 

0.14 

0.15 

0.15 

0.14 

0.093 

0.073 

0.075 

0.11 

0.079 

0.11 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.034 

0.034 

0.034 

0.052 

0.039 

0.062 

0.261 

0.261 

0.273 

0.336 

0.292 

0.336 

Tomato Vittoria (RG), 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.03 

0.06 

0.06 

0.07 

0.03 

0.03 

0.070 

0.073 

0.079 

0.093 

0.084 

0.095 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.020 

0.021 

0.021 

0.028 

0.035 

0.040 

0.144 

0.178 

0.184 

0.215 

0.173 

0.189 

Field trials – Southern Europe 

Tomato L'Hospitalet 

de Llobregat, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

0 

3 

6 

7 

13 

0.04 

0.02 

0.04 

0.03 

0.01 

0.045 

0.058 

0.088 

0.092 

0.075 

0.012 

<0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.018 

0.023 

0.036 

0.041 

0.041 

0.127 

0.125 

0.188 

0.187 

0.150 

Tomato Vale de 

Cavalos, 

Portugal, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

0 

3 

5 

7 

14 

0.06 

0.04 

0.03 

0.02 

0.01 

0.056 

0.061 

0.057 

0.059 

0.048 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.018 

0.019 

0.026 

0.026 

0.030 

0.158 

0.144 

0.137 

0.129 

0.112 

Tomato Petra, 

Greece, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

14 

0.01 

0.05 

0.04 

0.02 

0.02 

0.02 

0.01 

0.035 

0.057 

0.057 

0.038 

0.045 

0.041 

0.034 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.017 

0.024 

0.024 

0.023 

0.031 

0.026 

0.038 

0.086 

0.155 

0.145 

0.105 

0.120 

0.111 

0.106 
- 88 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Tomato Zapponeta 

(Fg), Italy, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

14 

0.01 

0.03 

0.03 

0.03 

0.03 

0.04 

0.04 

0.13 

0.13 

0.12 

0.13 

0.11 

0.065 

0.074 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.013 

0.015 

0.025 

0.023 

0.022 

0.042 

0.176 

0.197 

0.189 

0.209 

0.187 

0.151 

0.180 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used 

spirotetramat in tomatoes (based on data obtained from trials from Southern Europe and greenhouse): 

MRL-calculation based on data obtained from the Southern Region (field):

Individual data points for tomato are: 

0.12, 0.144, 0.188, 0.209 mg/kg 

Mean residue: 0.165 mg/kg; standard deviation: 0.041 mg/kg 

STMR: 0.166 mg/kg 

Highest residue: 0.209 mg/kg 

Method I: Rmax = 0.374 mg/kg 

Method II: Rber = 0.408 mg/kg 

Based on the data available for tomato in Southern Europe, a MRL of 0.5 mg/kg can be proposed. 

MRL-calculation based on data obtained from the greenhouse trials:

Individual data points for tomato are: 

0.215, 0.291, 0.336, 0.436, 0.442, 0.514, 0.677, 0.736 mg/kg 

Mean residue: 0.456 mg/kg; standard deviation: 0.182 

STMR: 0.439 mg/kg 

Highest residue: 0.736 mg/kg 

Method I: Rmax = 1.035 mg/kg 

Method II: Rber = 1.273 mg/kg 

Based on the data available for tomato in greenhouse, a MRL of 2 mg/kg can be proposed. 

Conclusion:

In 2004, altogether 12 residue trials (4 field trials in southern Europe and 8 trials in glasshouses) were 

carried out. Al trials were carried out according the intended use parameters and performed as residue

decline studies. The critical trials with highest residues levels were represented by the trials on protected 

crops. The results of the four field trials carried out in southern Europe resulted in lower residue levels (0.120 

– 0.209 mg/kg total residues of spirotetramat). Therefore the 8 European greenhouse trials were taken for 

MRL proposal. Based on these trials a MRL of 2 mg/kg can be proposed. 

Comments (RMS):

All residue trials were performed only in one season. But as the the highest residues were determined in the 

glasshouse trials the weather conditions in different saisons should not influence the outcome of the residue 

trials and the consumer risk asessment. 

B.7.6.7.2 Pepper 

Spirotetramat is applied for the use in peppers against aphids, scales and mites. The critical European GAPs 

in the greenhouse and in the field in southern Europe (S-EU) are summarized in Table B.7.6.7.2-1. 
- 89 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.7.2-1: GAP for residue situation in peppers 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-S F 4 Spray BBCH 87 0.072 g a.s./ha 3 

EU-N/S G 4 Spray BBCH 87 0.072 kg a.s./ha and m leafy 

surface, max. 0.144 kg 

a.s./ha 

3 

Reference: Determination of the Residues of BYI08330 in/on Pepper after Spraying of 

BYI08330 (100 OD) in the Greenhouse in the Netherlands, Germany, 

southern France, Portugal, Italy and Spain 

Author(s), year: Schöning R.; Wolters A.; 2005 

Report/Doc. number: RA-2026/04, including trials no. R 2004 0113/2, R 2004 0114/0, R 2004 0115/9, R 

2004 0116/7, R 2004 0117/5, R 2004 0118/3, R 2004 0119/1, R 2004 0120/5 

M-259820-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Pepper after Spraying of 

BYI08330 (100 OD) in the Field in Spain, southern France, Italy and Portugal 

Author(s), year: Schöning R.; Wolters A.; 2005 

Report/Doc. number: RA-2027/04, including trials no. R 2004 0121/3, R 2004 0122/1, R 2004 0124/8, R 

2004 0125/6 

M-260011-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Pepper after spraying of 

BYI08330 (240 SC) in the Greenhouse in Southern France, Germany, Italy 

and Portugal 

Author(s), year: Schöning R.; Helfrich P.; 2006 

Report/Doc. number: RA-2134/04, including trials no. R 2004 0791/2, R 2004 0792/0, R 2004 0793/9, R 

2004 0794/7 

M-263426-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 
- 90 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of the Residues of BYI08330 in/on Pepper after Spraying of 

BYI08330 (150 OD) in the Field in Italy and Portugal 

Author(s), year: Schöning R.; Wolters A.; 2006 

Report/Doc. number: RA-2039/05, including trials no. R 2005 0200/1, R 2005 0202/8 

M-266615-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Pepper after Spraying of 

BYI08330 (048 SC) in the Field in Italy and Portugal 

Author(s), year: Schöning R.; Wolters A.; 2006 

Report/Doc. number: RA-2046/05, including trials no. R 2005 0707/0, R 2005 0708/ 

M-266682-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

For southern Europe, 8 residue field trials were conducted on pepper. As test substance the oil based 

dispersion concentrates 100 OD and 150 OD and a suspensions concentrate 048 OD were used. 12 residue 

trials were carried out under greenhouse conditions using 100 OD and 240 SC formulations as test 

substances. In the greenhouse trials the use rate of spirotetramat was adapted to the height of the leafy 

surface of the pepper plants. The plant height at the last application was between 0.7 and 1.9 m. Hence, the 

application rate per ha ranged between 0.068 and 0.137 kg as/ha and a water volume of 750 – 1000 l/ha and 

meter leafy surface. 

An overview on the use pattern of the supervised residue trials conducted with different formulations of 

BYI08330 is given in Table B.7.6.7.2-2. 

Table B.7.6.7.2-2: Overview on European residue trials with BYI08330 in peppers 

Location Formulation No. of 

trials Year Use rate 

(g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Greenhouse 100 OD 8 2004 43.2-137* 450-1900 L/ha 4 6-8 

Greenhouse 240 SC** 4 2004 43.2-108* 450-1125 L/ha 4 6-7 

Field EU-S OD 100 4 2004 72 600-1000 L/ha 4 6-7 

Field EU-S OD 150 2 2005 72 500, 800 L/ha 4 7 

Field EU-S OD 150 2 2005 72 500, 800 L/ha 4 7 

* corresponding to 72 g a.s./ha per meter leafy surface 

** additive RME 500EW, 0.2% was added to the spray liquid at each application 

The last application was carried out at BBCH growth stage 68-85. 

Samples were taken before the last application, 0, 1, 3, 4-6 and 7 days after the last application. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 70 to 205 days. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc were determined by HPLC-ESI-MS/MS according to method 00857. 
- 91 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on pepper (all metabolites calculated as spirotetramat 

equivalent). 

The mean procedural recoveries at the fortification levels of 0.01 to 1.0 mg/kg for spirotetramat and its four 

metabolites ranged between 84 and 106 % and RSD < 20%; these results indicate that the methods used 

were suitable for this analysis. 

Findings:

A detailed summary of the residue results is given in Appendix I k. 

The total residue of spirotetramat in peppers grown in the greenhouse (12 trials) according to the European 

GAP ranged between 0.268 and 0.581 mg/kg. In pepper, from 8 field trials in southern Europe a total residue 

of 0.113 to 0.817 mg/kg could be determined. Generally residue data of day 3 after the last application were 

evaluated according to the PHI of the critical European GAP. If the total residue of spirotetramat at longer 

intervals exceeded the residue of day 3, the higher value was evaluated to cover the worst case residue. An 

overview of the residue data is reported in the table below. The residue data used for the evaluation are 

marked in bold. 

To determine the influence of different formulations (SC and OD) on the residue behaviour of BYI08330 

residues in pepper grown in the greenhouse and treated with BYI08330 OD 100 or SC 240 + RME were 

compared. Moreover, residues from field trials conducted with the SC 048 formulation were compared to 

residues in pepper treated with the OD 100 and 150 formulations. The results are corresponding with the 

total residue in pepper after application of the OD formulations. 

Main component of the total residue of spirotetramat in pepper is BYI08330-enol. The parent compound, 

BYI08330-ketohydroxy and BYI08330-enol-glucoside are minor components. BYI08330-monohydroxy was 

not detected in pepper fruit or in traces, only. 

Table B.7.6.7.2-3: Overview of European residue data for spirotetramat and its metabolites in pepper 

used 4 times with application rates of 0.076 kg a.s./ha (residues are calculated as spirotetramat 

equivalent): 

crop / 

formulatio

n 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Greenhouse trials 

Pepper, 

sweet 

100 OD 

Heerhugowaard, 

Netherlands, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.05 

0.10 

0.07 

0.08 

0.05 

0.04 

0.35 

0.38 

0.40 

0.41 

0.39 

0.46 

0.021 

0.021 

0.024 

0.024 

0.022 

0.027 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.016 

0.017 

0.018 

0.021 

0.023 

0.026 

0.449 

0.530 

0.524 

0.547 

0.497 

0.565 

Pepper, 

sweet 

100 OD 

Leichlingen, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

4 

7 

0.06 

0.11 

0.09 

0.07 

0.07 

0.04 

0.39 

0.36 

0.39 

0.38 

0.40 

0.46 

0.021 

0.021 

0.021 

0.022 

0.025 

0.021 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.054 

0.044 

0.053 

0.048 

0.053 

0.048 

0.537 

0.547 

0.566 

0.532 

0.560 

0.581 

Pepper, 

sweet 

100 OD 

Graveson, SFrance, 2004 fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.03 

0.07 

0.06 

0.05 

0.04 

0.04 

0.25 

0.29 

0.28 

0.31 

0.32 

0.29 

0.024 

0.041 

0.028 

0.027 

0.029 

0.025 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.019 

0.022 

0.020 

0.022 

0.025 

0.025 

0.335 

0.435 

0.400 

0.421 

0.426 

0.392 
- 92 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulatio

n 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Pepper, 

sweet 

100 OD 

Póvoa da 

Isenta, 

Portugal, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

6 

7 

0.03 

0.06 

0.03 

0.03 

0.04 

0.02 

0.29 

0.28 

0.25 

0.25 

0.26 

0.25 

0.027 

0.030 

0.026 

0.019 

0.023 

0.019 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.013 

0.013 

0.014 

0.014 

0.016 

0.018 

0.372 

0.395 

0.332 

0.325 

0.351 

0.319 

Pepper, 

sweet 

100 OD 

Molfetta 

(Bari), Italy, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.08 

0.14 

0.08 

0.12 

0.08 

0.13 

0.23 

0.25 

0.25 

0.31 

0.31 

0.34 

0.015 

0.017 

0.015 

0.021 

0.019 

0.025 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.019 

0.023 

0.020 

0.027 

0.030 

0.039 

0.356 

0.442 

0.377 

0.490 

0.451 

0.546 

Pepper, 

sweet 

100 OD 

Leichlingen, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

4 

7 

0.05 

0.11 

0.08 

0.07 

0.05 

0.05 

0.32 

0.30 

0.33 

0.26 

0.30 

0.35 

0.018 

0.016 

0.019 

0.015 

0.019 

0.018 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.052 

0.036 

0.040 

0.039 

0.046 

0.050 

0.452 

0.474 

0.481 

0.396 

0.427 

0.480 

Pepper, 

sweet 

100 OD 

Pernes les 

Fontaines, SFrance, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.02 

0.03 

0.03 

0.03 

0.01 

0.02 

0.17 

0.18 

0.19 

0.20 

0.20 

0.18 

0.014 

0.017 

0.017 

0.016 

0.017 

0.015 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.010 

0.010 

0.010 

0.010 

0.013 

0.013 

0.226 

0.249 

0.259 

0.268 

0.252 

0.240 

Pepper, 

sweet 

100 OD 

Mataró, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

4 

7 

0.03 

0.05 

0.06 

0.03 

0.03 

0.03 

0.37 

0.38 

0.42 

0.38 

0.42 

0.43 

0.018 

0.019 

0.020 

0.019 

0.020 

0.020 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.052 

0.034 

0.029 

0.036 

0.027 

0.044 

0.482 

0.495 

0.541 

0.477 

0.509 

0.536 

Pepper, 

sweet 

240 SC 

Graveson, SFrance, 2004 fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.03 

0.06 

0.06 

0.06 

0.05 

0.04 

0.28 

0.30 

0.31 

0.36 

0.32 

0.29 

0.029 

0.028 

0.032 

0.025 

0.028 

0.029 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.022 

0.023 

0.021 

0.026 

0.028 

0.029 

0.373 

0.423 

0.435 

0.483 

0.438 

0.400 

Pepper, 

sweet 

240 SC 

Leichlingen, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

4 

7 

0.09 

0.18 

0.13 

0.12 

0.12 

0.12 

0.21 

0.23 

0.28 

0.26 

0.27 

0.37 

0.013 

0.015 

0.016 

0.016 

0.017 

0.021 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.026 

0.027 

0.033 

0.038 

0.031 

0.051 

0.351 

0.464 

0.471 

0.446 

0.450 

0.574 

Pepper, 

sweet 

240 SC 

Molfetta 

(Bari), Italy, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.08 

0.16 

0.12 

0.10 

0.06 

0.12 

0.10 

0.11 

0.11 

0.13 

0.13 

0.15 

0.012 

0.012 

0.012 

0.012 

0.012 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.009 

0.009 

0.010 

0.016 

0.212 

0.302 

0.263 

0.263 

0.224 

0.311 

Pepper, 

sweet 

240 SC 

Póvoa da 

Isenta, 

Portugal, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

6 

7 

0.04 

0.09 

0.05 

0.04 

0.02 

0.03 

0.20 

0.20 

0.21 

0.21 

0.18 

0.19 

0.013 

0.023 

0.015 

0.014 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.010 

0.012 

0.011 

0.013 

0.013 

0.017 

0.275 

0.337 

0.298 

0.289 

0.237 

0.260 
- 93 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulatio

n 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Field trials – Southern Europe 

Pepper, 

sweet 

100 OD 

Alginet, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

6 

7 

0.13 

0.28 

0.20 

0.14 

0.08 

0.10 

0.51 

0.51 

0.55 

0.54 

0.51 

0.48 

0.034 

0.039 

0.057 

0.062 

0.047 

0.053 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.051 

0.043 

0.050 

0.063 

0.053 

0.066 

0.737 

0.884 

0.869 

0.817 

0.702 

0.711 

Pepper, 

sweet 

100 OD 

Le Burgaud, 

France, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

<0.01 

0.01 

0.01 

0.01 

<0.01 

<0.01 

0.19 

0.19 

0.15 

0.21 

0.18 

0.21 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.016 

0.014 

0.013 

0.019 

0.017 

0.022 

0.24 

0.238 

0.197 

0.263 

0.231 

0.266 

Pepper, 

sweet 

100 OD 

Giovinazzo 

(Bari), Italy, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

<0.01 

0.01 

0.01 

0.01 

<0.01 

<0.01 

0.11 

0.12 

0.13 

0.13 

0.16 

0.12 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.010 

0.009 

0.009 

0.010 

0.012 

0.011 

0.154 

0.163 

0.173 

0.174 

0.206 

0.165 

Pepper, 

sweet 

100 OD 

Salvaterra, 

Portugal, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.02 

0.04 

0.04 

0.02 

0.02 

0.02 

0.23 

0.25 

0.24 

0.25 

0.29 

0.29 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.015 

0.014 

0.013 

0.015 

0.018 

0.019 

0.289 

0.328 

0.317 

0.309 

0.352 

0.353 

Pepper, 

sweet 

150 OD 

Canosa 

(Bari), Italy, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.01 

0.03 

0.04 

0.02 

0.01 

0.01 

0.058 

0.048 

0.049 

0.052 

0.067 

0.092 

0.012 

0.012 

0.012 

0.012 

0.012 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.010 

0.012 

0.100 

0.110 

0.121 

0.104 

0.111 

0.139 

Pepper, 

sweet 

150 OD 

CaniceiraVale de 

Cavalos, 

Portugal, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.01 

0.03 

0.01 

0.01 

0.01 

0.01 

0.13 

0.15 

0.13 

0.12 

0.13 

0.098 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.008 

0.172 

0.212 

0.172 

0.162 

0.172 

0.140 

Pepper, 

sweet 

048 SC 

Canosa di 

Puglia (Bari), 

Italy, 2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.01 

0.04 

0.03 

0.02 

0.01 

0.01 

0.043 

0.050 

0.044 

0.053 

0.047 

0.069 

0.012 

0.012 

0.012 

0.014 

0.012 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.009 

0.085 

0.122 

0.106 

0.107 

0.089 

0.113 

Pepper, 

sweet 

048 SC 

Caniceira - 

Vale de 

Cavalos, 

Portugal, 

2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.01 

0.04 

0.02 

0.02 

0.02 

0.01 

0.089 

0.11 

0.096 

0.12 

0.11 

0.11 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.008 

0.131 

0.182 

0.148 

0.172 

0.162 

0.152 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used 

spirotetramat in peppers (based on data obtained from trials from Southern Europe and greenhouse): 
- 94 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

MRL-calculation based on data obtained from the Southern Region (field):

Individual data points for pepper are: 

0.113, 0.139, 0.172, 0.172, 0.205, 0.266, 0.353, 0.817 mg/kg 

Mean residue: 0.280 mg/kg; standard deviation: 0.230 mg/kg 

STMR: 0.189 mg/kg 

Highest residue: 0.817 mg/kg 

Method I: Rmax = 1.013 mg/kg 

Method II: Rber = 0.663 mg/kg 

Based on the data available for pepper in Southern Europe, a MRL of 2 mg/kg can be proposed. 

MRL-calculation based on data obtained from the greenhouse trials:

Individual data points for pepper are: 

0.268, 0.289, 0.311, 0.351, 0.426, 0.48, 0.483, 0.536, 0.546, 0.565, 0.574, 0.581 mg/kg 

Mean residue: 0.451 mg/kg; standard deviation: 0.182 

STMR: 0.482 mg/kg 

Highest residue: 0.581 mg/kg 

Method I: Rmax = 0.774 mg/kg 

Method II: Rber = 1.121 mg/kg 

Based on the data available for pepper in greenhouse, a MRL of 2 mg/kg can be proposed. 

Conclusion:

20 trials were carried out in greenhouse all over Europe regions during 2004 and 2005 (8 field trials and 12 

trials glasshouse trials). Spirotetramat is not intended to be used as an outdoor crop in northern Europe, 

therefore supervised outdoor residue trials were carried out in Southern European regions only. There was 

no significant difference between the residues in pepper grown in southern Europe and in glasshouses. 

Based on the submitted supervised residue trials a MRL of 2 mg/kg can be proposed. 

Comments (RMS):

No comments. 

B.7.6.7.3 Cucumber 

Spirotetramat is applied for the use in cucumber against aphids, whiteflies and mites. The critical European 

GAPs for the greenhouse and field uses of BYI08330 in cucumber are summarised in Table B.7.6.7.3-1. 

Table B.7.6.7.3-1: GAP for residue situation in cucumbers 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-S F 4 Spray BBCH 87 0.072 g a.s./ha 3 

EU-N/S G 4 Spray BBCH 87 0.072 kg a.s./ha and m leafy 

surface, max. 0.144 kg a.s./ 

ha 

3 

Reference: Determination of the residues of BYI08330 in/on cucumber after spraying of 

BYI08330 (100 OD) in the greenhouse in Germany, Italy, Spain and Greece 

Author(s), year: Cavaille C.; 2005 

Report/Doc. number: RA-2030/04, including trials no. R 2004 0130/2, R 2004 0131/0, R 2004 0132/9, R 

2004 0133/7, R 2004 0134/5, R 2004 0135/3, R 2004 0136/1, R 2004 0138/8 

M-259128-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 
- 95 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of the residues of BYI08330 in/on cucumber after spraying of 

BYI08330 (100 OD) in the field in Spain and Italy 

Author(s), year: Cavaille C.; 2005 

Report/Doc. number: RA-2028/04, including trials no. R 2004 0126/4, R 2004 0128/0, R 2004 0129/9 

M-259667-01-1 

Guideline(s): 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on cucumber after spraying of 

BYI08330 (150 OD) in the field in Spain and Italy 

Author(s), year: Ballesteros C.; 2005 

Report/Doc. number: RA-2043/05, including trials no. R 2005 0239/7, R 2005 0240/0, R 2005 0241/9, R 

2005 0715/1 

M-268869-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

For the magnitude of residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, 

BYI 08330-mono-hydroxy and BYI 08330-enol-Glc in cucumbers 7 trials in southern Europe and 8 trials 

under glasshouse conditions were performed. All trials were carried out with oil based dispersion 

concentrates containing 100 and 150 g a.s./L respectively. Spirotetramat was used four times in application 

rates of 72 g a.s./ha and spray volumes between 600 and 1000 L/ha. For the greenhouse application, the

product was used four times at application rates of 0.072 kg a.s./ha and meter leafy surface and a water 

volume of 750 L/ha and meter leafy surface (0.5 – 2. m), this is corresponding to 0.036 – 0.144 kg a.s./ha 

and a spray volume of 375 – 1500 L/ha. An overview on the supervised residue trials conducted with BYI

08330 OD formulations is given in Table B.7.6.7.3-2

Table B.7.6.7.3-2: Overview on European residue trials with spirotetramat in cucumbers 

Location Formulation No. of 

trials Year Use rate 

(g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Greenhouse OD 100 8 2004 36-144* 375-1500 L/ha 4 5-7 

Field S-EU OD 100 3 2004 72 600-1000 L/ha 4 7 

Field S-EU OD 150 4 2005 72 600-1000 L/ha 4 7-8 

* corresponding to 72 g a.s./ha per meter leafy surface 

The last applications were carried out at growth stage between BBCH 73 and BBCH 89. Samples were taken

before the last application, 0, 1, 3, 5-6 and 7 days after the last application. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 199 to 445 days for the trials carried out in 2004 and 77-

142 days for the residue trials from 2005. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc were determined by HPLC-ESI-MS/MS according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-mono-
- 96 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

hydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on cucumbers (all metabolites calculated as 

spirotetramat equivalent). 

The mean procedural recoveries at the fortification levels of 0.01 to 1.0 mg/kg for spirotetramat and its four 

metabolites ranged between 85 and 100 % and RSD < 20%; these results indicate that the methods used 

were suitable for this analysis. 

Findings:

A detailed summary of the residue results is given in Appendix I l. 

8 supervised residue trials with spirotetramat in cucumber were performed in glasshouse in 2004 and 

altogether 7 trials were carried out in southern Europe in 2004 and 2005. The total residues of spirotetramat 

in cucumbers grown in the greenhouse ranged between <0.054 and 0.077 mg/kg In cucumbers from 7 field 

trials in southern Europe total residues of <0.054 to 0.119 mg/kg were determined: In cucumbers from one of 

the 7 field trials (R 2005 0715/1) the total residue of spirotetramat was 0.119 mg/kg. In the study report (No.: 

RA-2043/05) a deviation concerning this trial (Trial No. R 2005 0715/1) was reported. Due to heavy weather 

conditions the crops from the primary performed trial were damaged. The trial was restarted in October 2005. 

But the daily mean temperatures during the trial process were 5-16°C. Fruits were small (average weight 

111-172 g) compared to cucumbers from the other trials conducted from June until August 2005: R 2005 

0239/7 (411-528 g), R 2005 0240/0 (227-318 g) and R 2005 0241/9 (236-270 g). Therefore, the higher 

residues in cucumber from trial R 2005 0715/1 can be explained by lower temperatures slowing down 

metabolic processes and by the smaller size of the cucumber accompanied with a higher surface/volume 

ratio leading to higher residues expressed in mg/kg. This value was not excluded as an outlier, because 

growing of cucumber in October/November is according to agricultural practice in southern European 

countries although main growing season is summer. 

All trials were performed according the intended European GAPs. An overview of the residue data is 

reported in the table below. The residue data used for the evaluation are marked in bold. 

The main component of the total residue was parent compound. In addition, traces of enol or ketohydroxy 

were found. BYI08330-monohydroxy and enol-glucoside were not detected. 

Table B.7.6.7.3-3: Overview of European residue data for spirotetramat and its metabolites in 

cucumber used 4 times with application rates of 0.076 kg a.s./ha (residues are calculated as 

spirotetramat equivalent): 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Greenhouse trials 

Cucumber / 

OD 100 

Leichlingen, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

<0.01 

0.02 

0.02 

0.02 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.017 

0.017 

0.023 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.069 

0.069 

0.075 

0.055 

<0.054 

Cucumber / 

OD 100 

Santa 

Croce 

Camerina, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

<0.01 

0.02 

0.03 

0.01 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.015 

0.017 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.064 

0.077 

0.059 

<0.054 

<0.054 

Cucumber / 

OD 100 

Viladecans, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

<0.01 

0.04 

0.03 

0.02 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.020 

0.020 

0.018 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.092 

0.082 

0.070 

<0.054 

<0.054 
- 97 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Cucumber / 

OD 100 

Aronas, 

Greece, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

<0.01 

0.03 

0.05 

0.02 

0.02 

0.01 

<0.012 

0.022 

0.016 

<0.012 

<0.012 

<0.012 

<0.012 

0.022 

0.020 

0.022 

0.015 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.094 

0.106 

0.074 

0.067 

0.055 

Cucumber / 

OD 100 

Leichlingen, 

Germany, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.02 

0.05 

0.05 

0.03 

0.02 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.019 

0.024 

0.019 

0.015 

0.020 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.071 

0.106 

0.101 

0.077 

0.072 

<0.054 

Cucumber / 

OD 100 

RMolfetta 

(Bari), Italy, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

<0.01 

0.01 

0.01 

<0.01 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.026 

0.015 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.068 

0.057 

<0.054 

<0.054 

<0.054 

Cucumber / 

OD 100 

Roquetas 

de Mar, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

6 

7 

<0.01 

0.02 

<0.01 

<0.01 

<0.01 

<0.01 

<0.012 

0.019 

0.012 

<0.012 

<0.012 

<0.012 

0.013 

0.038 

0.039 

0.015 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.055 

0.097 

0.081 

0.057 

<0.054 

<0.054 

Cucumber / 

OD 100 

Esovalta, 

Greece, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

<0.01 

0.04 

0.01 

<0.01 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.048 

0.021 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.120 

0.063 

<0.054 

<0.054 

<0.054 

Field trials – Southern Europe 

Cucumber / 

OD 100 

Brenes, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

6 

7 

<0.01 

0.04 

0.02 

0.02 

0.01 

0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.018 

0.015 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.090 

0.067 

0.064 

<0.054 

<0.054 

Cucumber / 

OD 100 

Malgrat de 

Mar, Spain, 

2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

6 

7 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

Cucumber / 

OD 100 

Zapponeta 

Foggia, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

<0.01 

0.02 

0.01 

<0.01 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.033 

0.015 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.085 

0.057 

<0.054 

<0.054 

<0.054 

Cucumber / 

OD 150 

Alginet, 

Spain, 2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

6 

7 

<0.01 

0.03 

0.02 

0.02 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.074 

0.064 

0.064 

<0.054 

<0.054 
- 98 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Cucumber / 

OD 150 

Malgrat de 

Mar, Spain, 

2005 

fruit 

fruit 

fruit 

fruit 

0 

3 

5 

7 

<0.01 

<0.01 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

<0.054 

<0.054 

<0.054 

Cucumber / 

OD 150 

Vittoria, 

Italy, 2005 

fruit 

fruit 

fruit 

fruit 

0 

3 

5 

7 

0.01 

<0.01 

<0.01 

<0.01 

0.017 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

0.059 

<0.054 

<0.054 

<0.054 

Cucumber / 

OD 150 

Zapponeta, 

Italy, 2005 

fruit 

fruit 

fruit 

fruit 

fruit 

fruit 

0* 

0 

1 

3 

5 

7 

0.03 

0.06 

0.07 

0.06 

0.05 

0.03 

0.021 

0.035 

0.025 

0.027 

0.020 

0.019 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.083 

0.127 

0.127 

0.119 

0.102 

0.081 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used 

spirotetramat in cucumber (based on data obtained from trials from southern Europe and greenhouse): 

MRL-calculation based on data obtained from the Southern Region (field):

Individual data points for cucumber are: 

<0.054, <0.054, <0.054, <0.054, 0.064, 0.064, 0.119 mg/kg 

Mean residue: 0.066 mg/kg; standard deviation: 0.024 mg/kg 

STMR: 0.055 mg/kg 

Highest residue: 0.119 mg/kg 

Method I: Rmax = 0.147 mg/kg 

Method II: Rber = 0.128 mg/kg 

Based on the data available for cucumber in southern Europe, a MRL of 0.2 mg/kg can be proposed. 

MRL-calculation based on data obtained from the greenhouse trials:

Individual data points for cucumber are: 

<0.054, <0.054, 0.057, 0.059, 0.070, 0.074, 0.075, 0.077 mg/kg 

Mean residue: 0.065 mg/kg; standard deviation: 0.010 

STMR: 0.065 mg/kg 

Highest residue: 0.077 mg/kg 

Method I: Rmax = 0.096 mg/kg 

Method II: Rber = 0.150 mg/kg 

Based on the data available for cucumber in greenhouse, a MRL of 0.2 mg/kg can be proposed. 

Conclusion:

15 trials were carried out in greenhouse and southern Europe regions during 2004 and 2005 (7 field trials 

and 8 trials in glasshouses). Spirotetramat is not intended to be used as an outdoor crop in northern Europe, 

therefore supervised outdoor residue trials were carried out in Southern European regions only. There was 

no significant difference between the residues in pepper grown in southern Europe and in glasshouses. 

Based on the submitted supervised residue trials a MRL of 0.2 mg/kg can be proposed. 

Comments (RMS):

The residue trials in glasshouse were all performed within one season. But with respect to the protected 

cultivation of cucumber, the weather conditions in different saisons should not influence the outcome of the 

residue trials and the consumer risk asessment. 
- 99 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.6.7.4 Melons 

Spirotetramat is applied for the use in melon against aphids, whiteflies and mites. The critical European 

GAPs for the greenhouse and field uses of spirotetramat in melon are summarised in Table 6.3.1.12-1. 

Table B.7.6.7.4-1: GAP for residue situation in melons 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-S F 4 Spray BBCH 87 0.072 g a.s./ha 3 

EU-N/S G 4 Spray BBCH 87 0.072 kg a.s./ha 3 

Reference: Determination of the Residues of BYI08330 in/on Melon after Spraying of 

BYI08330 (100 OD) in the Greenhouse in Italy, Spain, Southern France and 

Portugal 

Author(s), year: Cavaille C.; 2006 

Report/Doc. number: RA-2128/04, including trials no. R 2004 0836/6, R 2004 0837/4, R 2004 0838/2, R 

2004 0839/0, R 2004 0840/4, R 2004 0841/2, R 2004 0881/1, R 2004 0883/0 

M-259446-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Melon after Spraying of 

BYI08330 (100 OD) in the Field in Italy, Spain and Greece 

Author(s), year: Cavaille C.; 2005 

Report/Doc. number: RA-2129/04, including trials no. R 2004 0842/0, R 2004 0843/9, R 2004 0844/7, R 

2004 0845/5 

M-259449-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Melon after Spraying of 

BYI08330 (150 OD) in the Field in Greece, Spain, Portugal and Italy 

Author(s), year: Cavaille C.; 2005 

Report/Doc. number: RA-2042/05, including trials no. R 2005 0230/3, R 2005 0231/1, R 2005 0233/8, R 

2005 0234/6, R 2005 0717/8 

M-268388-02-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

For the magnitude of residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, 

BYI 08330-mono-hydroxy and BYI 08330-enol-Glc in melons 9 trials in southern Europe (Italy, Spain, Greece 

and Portugal) and 8 trials under glasshouse conditions were performed in 2004 and 2005. All trials were 
- 100 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

carried out with oil based dispersion concentrates containing 100 and 150 g a.s./L respectively. 

Spirotetramat was used four times in application rates of 72 g a.s./ha and spray volumes between 600 and 

1000 L/ha. An overview on the supervised residue trials conducted with BYI 08330 100 OD formulation is

given in Table B.7.6.7.4-2 

Table B.7.6.7.4-2: Overview on European residue trials with spirotetramat in melons 

Location Formulation No. of 

trials Year Use rate 

(g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Greenhouse OD 100 8 2004 72 600-1000 L/ha 4 6-7 

Field S-EU OD 100 4 2004 72 500-750 L/ha 4 6-7 

Field S-EU OD 150 5 2005 72 600-1000 L/ha 4 7-10 

The last applications were carried out at growth stage between BBCH 79 and BBCH 89. Samples were taken

before the last application, 0, 1, 3, 5-6 and 7 days after the last application. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 393 to 455 days for the trials carried out in 2004 and 82-

122 days for the residue trials from 2005. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc in melon fruit, pulp and peel were determined by HPLC-ESI-MS/MS 

according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on melon fruits, pulp and peel (all metabolites calculated 

as spirotetramat equivalent). 

The mean procedural recoveries at the fortification levels of 0.01 to 1.0 mg/kg for spirotetramat and its four 

metabolites ranged between 85 and 108 % and RSD < 20%; these results indicate that the methods used 

were suitable for this analysis. 

Findings:

A detailed summary of the residue results is given in Appendix I m. 

8 supervised residue trials with spirotetramat in melon were performed in glasshouse in 2004 and altogether 

9 trials were carried out in southern Europe in 2004 and 2005. The total residues of spirotetramat in melons 

(whole fruit) grown in the greenhouse ranged between <0.054 and 0.00,057 mg/kg. In melons from 9 field

trials in southern Europe total residues of <0.054 to 0.088 mg/kg were determined. No residues were 

detected in melon pulp (total residue <0.054 mg/kg). In melon peel the total residue of spirotetramat ranged 

between <0,054 and 0.165 mg/kg. 

All trials were performed according the intended European GAPs. An overview of the residue data is 

reported in the table below.The residue data used for the evaluation are marked in bold. 

The total residue of BYI08330 in melon peel from the remaining trials collected at the PHI of 3 days after 4 

applications is composed of spirotetramat and/or the enol metabolite; except melon fruit, pulp and peel from 

trials R 2005 0230/3. In this trial the total residues of spirotetramat was mainly composed of BYI08330-

monohydroxy. 
- 101 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.7.4-3: Overview of European residue data for spirotetramat and its metabolites in melon 

used 4 times with application rates of 0.076 kg a.s./ha (residues are calculated as spirotetramat 

equivalent): 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Greenhouse trials 

Melon 

OD 100 

Molfetta, 

Italy, 2004 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

0* 

0 

1 

3 

3 

3 

5 

5 

5 

7 

0.01 

0.02 

0.02 

0.01 

<0.01 

0.05 

0.02 

<0.01 

0.02 

0.02 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.019 

<0.012 

<0.012 

0.015 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.064 

0.064 

<0.054 

<0.054 

0.101

0.064 

<0.054 

0.067 

0.064 

Melon 

OD 100 

Sanlucar de 

Bda (Monte 

Algaida), 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

0* 

0 

1 

3 

3 

3 

5 

5 

5 

7 

<0.01 

0.02 

0.02 

<0.01 

<0.01 

0.01 

<0.01 

<0.01 

0.02 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.021 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.015

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.064 

0.064 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

0.076 

<0.054 

Melon 

OD 100 

Montfavet, 

S-France, 

2004 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

0* 

0 

1 

3 

3 

3 

6 

6 

6 

7 

<0.01 

<0.01 

<0.01 

0.01 

<0.01 

0.02 

<0.01 

<0.01 

0.02 

<0.01 

<0.012 

<0.012 

<0.012 

0.014 

<0.012 

0.027 

<0.012 

<0.012 

0.024 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

<0.054 

<0.054 

0.056 

<0.054 

0.079

<0.054 

<0.054 

0.076 

<0.054 

Melon 

OD 100 

Torres 

Vedras, 

Portugal, 

2004 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

0* 

0 

1 

3 

3 

3 

5 

5 

5 

7 

<0.01 

0.01 

0.01 

0.01 

<0.01 

0.04 

0.01 

<0.01 

0.03 

0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.017 

<0.012 

<0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.015 

0.012 

<0.012 

0.029 

<0.012 

<0.012 

0.027 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

<0.054 

0.057 

<0.054 

<0.054 

0.106 

<0.054 

<0.054 

0.089 

<0.054 

Melon 

OD 100 

Freiria, 

Portugal, 

2004 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

0* 

0 

1 

3 

3 

3 

5 

5 

5 

7 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.01 

<0.01 

0.02 

0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

<0.012 

<0.012 

0.020 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

0.072 

<0.054 
- 102 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Melon 

OD 100 

Manfredoni

a (Fg), Italy, 

2004 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

0* 

0 

1 

3 

3 

3 

5 

5 

5

7 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.01 

<0.01 

<0.01 

0.02 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.013 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

0.065 

<0.054 

Melon 

OD 100 

Los 

Palacios 

Sevilla, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

0* 

0 

1 

3 

3 

3 

4 

4 

4 

7 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.01 

<0.01 

<0.01 

0.01 

0.01 

0.012 

0.017 

0.019 

0.015 

<0.012 

0.022 

<0.012 

<0.012 

0.015 

0.019 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.059 

0.061 

0.057 

<0.054 

0.064 

<0.054 

<0.054 

0.057 

0.061 

Melon 

OD 100 

Vacquiers, 

France, 

2004 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

0* 

0 

1 

3 

3 

3 

5 

5 

5 

7 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

Field trials – Southern Europe 

Melon 

OD 100 

Andria 

(Bari), Italy, 

2004 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

fruit 

pulp 

peel 

0* 

0 

1 

3 

3 

3 

5 

7 

7 

7 

0.02 

0.05 

0.05 

0.04 

<0.01 

0.08 

0.04 

0.03 

<0.01 

0.10 

<0.012 

<0.012 

0.014 

<0.012 

<0.012 

0.021 

<0.012 

<0.012 

<0.012 

0.025 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.064 

0.094 

0.096 

0.084 

<0.054 

0.133 

0.084 

0.074 

<0.054 

0.157 

Melon 

OD 100 

Gava 

(Barcelona), 

Spain, 2004 

fruit 

fruit 

pulp 

peel 

fruit 

fruit 

pulp 

peel 

1 

3 

3 

3 

4 

7 

7 

7 

<0.01 

<0.01 

<0.01 

0.02 

<0.01 

<0.01 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

0.026 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

<0.054 

<0.054 

0.078 

<0.054 

<0.054 

<0.054 

<0.054 
- 103 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Melon 

OD 100 

Alginet, 

Spain, 2004 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

fruit 

pulp 

peel 

0* 

0 

1 

3 

3 

3

6 

7 

7 

7 

0.02 

0.03 

0.02 

0.02 

<0.01 

0.06 

0.02 

0.01 

<0.01 

0.03 

0.025 

0.043 

0.027 

0.036 

<0.012 

0.073 

0.026 

0.021 

<0.012 

0.041 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.077 

0.105 

0.079 

0.088 

<0.054 

0.165 

0.078 

0.063 

<0.054 

0.103 

Melon 

OD 100 

Aronas, 

Greece, 

2004 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

fruit 

pulp 

peel 

0 

0 

1 

3 

3 

3 

5 

7 

7 

7 

<0.01 

0.01 

0.02 

0.01 

<0.01 

0.01 

<0.01 

<0.01 

<0.01 

0.01 

<0.012 

0.019 

0.020 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.061 

0.072 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

Melon 

OD 150 

AronasKaterini, 

Greece, 

2005 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

0 

3 

3 

3 

5 

5 

5 

7 

7 

7 

0.01 

<0.01 

<0.01 

0.02 

<0.01 

<0.01 

0.02 

<0.01 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.049 

0.037 

0.033 

0.032 

0.023 

0.022 

0.028 

0.031 

0.022 

0.019 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.091 

0.079 

0.075 

0.084 

0.065 

0.064 

0.080 

0.073 

0.064 

0.061 

Melon 

OD 150 

Gava 

(Barcelona), 

Spain, 2005 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

0 

3 

3 

3 

5 

5 

5 

7 

7 

7 

<0.01 

<0.01 

<0.01 

0.03 

<0.01 

<0.01 

0.02 

<0.01 

<0.01 

0.02 

0.014 

0.014 

<0.012 

0.041 

<0.012 

<0.012 

0.029 

<0.012 

<0.012 

0.015 

<0.012 

<0.012 

<0.012 

<0.012

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.056 

0.056 

<0.054 

0.103 

<0.054 

<0.054 

0.081 

<0.054 

<0.054 

0.067 

Melon 

OD 150 

Aldeia 

Gavinha, 

Portugal, 

2005 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

0* 

0 

1 

1 

1 

3 

3 

3 

4 

4 

4 

7 

7 

7 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.012 

0.016 

0.021 

<0.012 

0.041 

0.017 

<0.012 

0.036 

0.015 

<0.012 

0.031 

0.012 

<0.012 

0.023 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.058 

0.063 

<0.054 

0.083 

0.059 

<0.054 

0.078 

0.057 

<0.054 

0.073 

<0.054 

<0.054 

0.065 
- 104 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Melon 

OD 150 

Licodia 

Eubea 

(CT.), Italy, 

2005 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

0} 

0 

1 

3 

3 

3 

5 

5 

5 

7 

7 

7 

<0.01 

0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.031 

<0.012 

<0.012 

0.016 

<0.012 

<0.012 

0.015 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

0.073 

<0.054 

<0.054 

0.058 

<0.054 

<0.054 

0.057 

Melon 

OD 150 

Alginet, 

Spain, 2005 

fruit 

fruit 

fruit 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

fruit 

pulp 

peel 

0* 

0 

1 

3 

3 

3 

4 

4 

4 

7 

7 

7 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.012 

0.013 

<0.012 

<0.012 

<0.012 

0.018

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.055 

<0.054 

<0.054 

<0.054 

0.060 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

<0.054 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used 

spirotetramat in melon (based on data obtained from trials from southern Europe and greenhouse): 

MRL-calculation based on data obtained from the Southern Region (field):

Individual data points for melon are: 

<0.054, <0.054, <0.054, <0.054, 0.056, 0.059, 0.079, 0.084, 0.088 mg/kg 

Mean residue: 0.065 mg/kg; standard deviation: 0.015 mg/kg 

STMR: 0.056 mg/kg 

Highest residue: 0.088 mg/kg 

Method I: Rmax = 0.109 mg/kg 

Method II: Rber = 0.163 mg/kg 

Based on the data available for melon in southern Europe, a MRL of 0.2 mg/kg can be proposed. 

MRL-calculation based on data obtained from the greenhouse trials:

Individual data points for melon are: 

<0.054,< 0.054, <0.054, <0.054, <0.054, <0.054, 0.056, 0.057 mg/kg 

Mean residue: 0.055 mg/kg; standard deviation: 0.001 

STMR: 0.054 mg/kg 

Highest residue: 0.057 mg/kg 

Method I: Rmax = 0.058 mg/kg 

Method II: Rber = 0.111 mg/kg 

Based on the data available for melon in greenhouse, a MRL of 0.2 mg/kg can be proposed. 

Conclusion:

17 trials were carried out in greenhouse and southern Europe regions during 2004 and 2005 (7 field trials 

and 8 trials in glasshouses). Spirotetramat is not intended to be used on melons as an outdoor crop in

northern Europe, therefore supervised outdoor residue trials were carried out in Southern European regions 
- 105 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

only. The residues in melons grown in southern Europe were slightly higher than those which were grown in 

glasshouses. Based on the submitted supervised residue trials a MRL of 0.2 mg/kg can be proposed. 

Comments (RMS):

The residue trials in glasshouse were all performed within one season. But with respect to the protected 

cultivation of cucumber, the weather conditions in different saisons should not influence the outcome of the 

residue trials and the consumer risk asessment. 

B.7.6.8 Brassica vegetables 

B.7.6.8.1 Flowering brassica 

Spirotetramat is applied for control of aphids in brassica vegetables. The critical European GAPs for the 

greenhouse and field uses of spirotetramat in flowering brassica are summarised in Table B.7.6.8-1. 

Table B.7.6.8-1: GAP for residue situation in flowering brassica 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 2 Spray BBCH 79 0.072 g a.s./ha 3 

EU-S F 2 Spray BBCH 79 0.072 g a.s./ha 3 

Reference: Determination of the residues of BYI08330 in/on broccoli after spraying of 

BYI08330 (100 OD) in the field in Germany and United Kingdom 

Author(s), year: Bardel P.; Freitag T.; 2005 

Report/Doc. number: RA-2022/04, including trials no. R 2004 0105/1, R 2004 0108/6 

M-259571-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on cauliflower after spraying of 

BYI08330 (100 OD) in the field in Germany and France 

Author(s), year: Zimmer D.; Freitag T.; 2005 

Report/Doc. number: RA-2023/04, including trials no. R 2004 0109/4, R 2004 0110/8 

M-259580-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 
- 106 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of the residues of BYI08330 in/on broccoli after spraying of 

BYI08330 (100 OD) in the field in Italy 

Author(s), year: Bardel P.; Freitag T.; 2006 

Report/Doc. number: RA-2024/04, including trials no. R 2004 0111/6 

M-259272-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on cauliflower after spraying of 

BYI08330 (100 OD) in the field in France 

Author(s), year: Zimmer D.; Freitag T.; 2005 

Report/Doc. number: RA-2025/04, including trials no. R 2004 0112/4 

M-258975-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on broccoli and cauliflower 

after spraying of BYI08330 (150 OD) in the field in Germany, northern 

France, and United Kingdom 

Author(s), year: Freitag T., Wieland K. 2006 

Report/Doc. number: RA-2062/05, including trials no. R 2005 0363/6, R 2005 0364/4, R 2005 0365/2, R 

2005 1017/9, R 2005 1047/0 

M-275226-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on broccoli and cauliflower 

after spraying of BYI08330 (150 OD) in the field in Italy and Spain 

Author(s), year: Freitag T., Wieland K., 2006 

Report/Doc. number: RA-2063/05, including trials no. R 2005 036/1, R 2005 0362/8 

M-275233-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

The magnitude of residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 

08330-mono-hydroxy and BYI 08330-enol-Glc in/on broccoli and cauliflower harvested following the 
- 107 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

treatment with BYI 08330 formulations (100 OD, 150 OD) under field conditions was determined in northern 

(Germany, UK and N-France) and southern Europe (Italy, S-France and Spain) in 2004 and 2005. 

Cauliflower is classified as major crops in northern Europe and as minor crop in southern Europe. For 

extrapolation to the whole group of flowering brassica, a minimum of 4 trials on cauliflower and 4 trials on 

broccoli are required. In northern Europe 4 trials on cauliflower and 5 trials on broccoli were performed. For 

southern Europe two trials on broccoli and two trials on cauliflower were carried out. An overview on the 

supervised residue trials conducted with different formulations of spirotetramat is given in Table B.7.6.8.1-2. 

Table B.7.6.8.1-2: Overview on European residue trials with BYI08330 in flowering brassica 

Location Formulation No. of 

trials Year Use rate (g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Field N-EU OD 100 4 2004 72-77 300-323 3 7 

Field N-EU OD 150 4 2005 72 500-600 2-3 14-21 

Field S-EU OD 100 2 2004 72 500,800 3 7 

Field S-EU OD 150 2 2005 72 600 3 14 

In 2004, 3 spray applications of spirotetramat were performed with a spray interval of 7 days. Samples were 

taken before the last application, 0, 3, 7, 13-14 and 21 days after the last application. The notifier stated that 

due to new results from biological trials the critical GAP changed: The number of applications was changed 

from 3 to 2 and the spray interval from 7 days to 14 days. Therefore the residue trials from 2005 were

performed with 3 applications and a spray interval of 14 days. Samples were taken 0-21 days after the last 

application. To cover the use pattern with two applications additional samples were taken directly after the 

second application and 3 days later. In trial R 2005 1047/0 the 3rd application was delayed for one week, 

because the plants grew slowly due to cold weather conditions. 

The last application was carried out at growth stage BBCH 41 – 49. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 34 to 283 days. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc were determined by HPLC-ESI-MS/MS according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on flowering brassica (all metabolites were calculated as 

spirotetramat equivalent). 

The mean procedural recoveries at the fortification levels of 0.01 to 10.0 mg/kg for spirotetramat and its four 

metabolites ranged between 70 and 110 % and RSD was <20%; these results indicate that the methods 

used were suitable for this analysis. 

Findings:

A detailed summary of the residue results is given in Appendix In. 

Nearly all residue trials for the residue behaviour of spirotetramat on cauliflower and broccoli were carried out 

with 3 applications per seasons. Number of applications and spray interval (6-8 days instead of 14 days) in 

the submitted trials carried out in 2004 are not in accordance with the intended use for flowering brassica. In 

the residue trials performed in 2005, the first specimens were taken directly after the 2nd application and 3 

days later, therefore it was possible to compare the residues after three and two applications. 

Neither the number of applications nor the time interval between the applications seems to have any 

influence on the resulting residues. Residues of total spirotetramat in flowering brassica after 3 applications 

ranged between 0.11 and 0.58 mg/kg whereas after 2 applications residues from 0.16 to 0.64 mg/kg were 

detected. An overview on the results of the residue data is summarized in the table below. The residue

values used for evaluation are marked with bold numbers. 
- 108 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The total residue of spirotetramat is mainly composed of the enol and the ketohydroxy metabolites. The

parent compound and the enol-glucoside were present at lower amounts. BYI08330-monohydroxy was not 

detected or in traces, only. 

Table B.7.6.8-3: Overview of European residue data for spirotetramat and its metabolites in flowering 

brassica used 2-3 times with application rates of 0.076 kg a.s./ha (residues are calculated as 

spirotetramat equivalent): 

crop / 

No of appl./ 

fomulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Field trials – Northern Europe 

broccoli/ 

3 appl./ 

OD 100 

Langenfeld 

Germany, 

2004 

curd 

curd 

curd 

curd 

curd 

0* 

0 

3 

7 

13 

<0.01 

0.08 

0.07 

0.01 

0.01 

0.17 

0.17 

0.20 

0.14 

0.097 

0.21 

0.22 

0.28 

0.20 

0.12 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.013 

0.013 

0.016 

0.012 

0.008 

0.415 

0.495 

0.578 

0.374 

0.247 

broccoli/ 

3 appl./ 

OD 100 

Rollesby 

United 

Kingdom, 

2004 

curd 

curd 

curd 

curd 

curd 

curd 

0* 

0 

3 

7 

14 

21 

0.01 

0.24 

0.09 

<0.01 

<0.01 

<0.01 

0.29 

0.48 

0.28 

0.29 

0.18 

0.15 

0.067 

0.14 

0.13 

0.13 

0.10 

0.048 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.009 

0.008 

0.009 

0.008 

0.008 

0.008 

0.388 

0.880 

0.521 

0.450 

0.310 

0.228 

cauliflower/ 

3 appl./ 

OD 100 

Langenfeld 

Germany, 

2004 

curd 

curd 

curd 

curd 

curd 

0* 

0 

3 

7 

13 

<0.01 

0.02 

<0.01 

<0.01 

<0.01 

0.074 

0.033 

0.055 

0.019 

0.013 

0.20 

0.24 

0.34 

0.28 

0.14 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.011 

0.010 

0.010 

0.008 

0.304 

0.316 

0.427 

0.331 

0.183 

cauliflower/ 

3 appl./ 

OD 100 

Criquebeuf 

sur Seine 

N-France, 

2004 

curd 

curd 

curd 

curd 

curd 

curd 

0* 

0 

3 

7 

14 

21 

<0.01 

0.01 

0.02 

<0.01 

<0.01 

<0.01 

0.035 

0.079 

0.077 

0.14 

0.15 

0.12 

0.034 

0.048 

0.046 

0.069 

0.061 

0.076 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.008 

0.099 

0.157 

0.163 

0.239 

0.241 

0.226 

broccoli/ 

3 appl./ 

OD 150 

Leichlingen 

Germany, 

2005 

curd 

curd 

curd 

curd 

curd 

curd 

curd 

curd 

-14 

-11 

0* 

0 

3 

7 

14 

21 

0.57 

0.19 

0.01 

0.10 

0.01 

<0.01 

<0.01 

<0.01 

0.25 

0.24 

0.073 

0.26 

0.14 

0.18 

0.89 

0.092 

0.10 

0.18 

0.074 

0.17 

0.13 

0.15 

0.047 

0.038 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<o.012 

<0.012 

<0.008 

0.019 

0.011 

0.008 

0.021 

0.032 

0.011 

0.011 

0.940 

0.641 

0.180 

0.550 

0.313 

0.384 

0.169 

0.163 

broccoli/ 

3 appl./ 

OD 150 

Ennemain 

N-France, 

2005 

curd 

curd 

curd 

curd 

curd 

curd 

-14 

-11 

0 

3 

7 

14 

0.09 

0.03 

0.11 

0.01 

0.01 

0.01 

0.28 

0.12 

0.078 

0.048 

0.046 

0.033 

0.12 

0.082 

0.047 

0.032 

0.025 

0.022 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

0.018 

0.008 

<0.008 

<0.008 

0.008 

0.510 

0.262 

0.255 

0.110 

0.101 

0.085 

cauliflower/ 

3 appl./ 

OD 150 

Schauernheim 

Germany, 

2005 

curd 

curd 

curd 

curd 

curd 

curd 

curd 

curd 

-14 

-11 

0* 

0 

3 

7 

14 

21 

0.01 

<0.01 

<0.01 

0.02 

0.02 

0.02 

0.01 

<0.01 

0.11 

0.15 

0.091 

0.13 

0.14 

0.13 

0.12 

0.086 

0.027 

0.029 

0.023 

0.048 

0.040 

0.031 

0.034 

0.030 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

0.008 

0.008 

<0.008 

0.008 

0.008 

0.167 

0.209 

0.144 

0.218 

0.220 

0.201 

0.184 

0.146 
- 109 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

No of appl./ 

fomulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

broccoli/ 

2 appl./ 

OD 150 

Mecklenbeuren 

Germany, 

2005 

curd 

curd 

0 

3 

0.07 

0.01 

0.15 

0.18 

0.099 

0.098 

<0.012 

<0.012 

0.008 

0.008 

0.339 

0.308 

cauliflower/ 

3 appl./ 

OD 150 

Ipswich 

United 

Kingdom, 

2005 

curd 

curd 

curd 

curd 

curd 

curd 

-21 

-19 

0 

3 

7 

13 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.079 

0.12 

0.23 

0.24 

0.31 

0.25 

0.012 

0.012 

0.036 

0.059 

0.029 

0.039 

<0.012 

0.012 

<0.012 

<0.012 

<0.012 

0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.121 

0.162 

0.296 

0.329 

0.369 

0.319 

Field trials – Southern Europe 

broccoli/ 

3 appl./ 

OD 100 

Zapponeta 

Italy, 2004 

curd 

curd 

curd 

curd 

curd 

0* 

0 

3 

7 

14 

0.04 

0.13 

0.02 

0.02 

0.01 

0.13 

0.19 

0.20 

0.31 

0.25 

0.069 

0.094 

0.080 

0.089 

0.068 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

0.008 

<0.008 

0.008 

0.008 

0.259 

0.434 

0.320 

0.439 

0.348 

cauliflower/ 

3 appl./ 

OD 100 

Fenouillet 

S-France, 

2004 

curd 

curd 

curd 

curd 

curd 

curd 

0* 

0 

3 

7 

14 

20 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.075 

0.095 

0.077 

0.13 

0.13 

0.11 

0.067 

0.078 

0.081 

0.10 

0.074 

0.067 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.008 

0.172 

0.203 

0.188 

0.260 

0.234 

0.207 

broccoli/ 

3 appl./ 

OD 150 

Manfredoni

a 

Italy, 2005 

curd 

curd 

curd 

curd 

curd 

curd 

curd 

curd 

-14 

-11 

0* 

0 

3 

8 

14 

20 

0.08 

0.06 

0.01 

0.11 

0.01 

0.01 

0.01 

<0.01 

0.11 

0.099 

0.11 

0.15 

0.11 

0.12 

0.13 

0.087 

0.037 

0.036 

0.025 

0.043 

0.029 

0.035 

0.036 

0.026 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

0.008 

0.008 

0.008 

0.008 

0.008 

0.008 

0.011 

0.247 

0.215 

0.165 

0.323 

0.169 

0.185 

0.196 

0.146 

cauliflower/ 

3 appl./ 

OD 150 

Gava 

Spain, 2005 

whole pl. 

whole pl. 

curd 

curd 

curd 

curd 

-14 

-11 

0* 

0 

3 

7 

1.0 

0.06 

0.01 

0.13 

0.01 

<0.01 

0.23 

0.10 

0.039 

0.085 

0.070 

0.084 

0.049 

0.019 

0.012 

0.013 

0.013 

0.014 

<0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.013 

0.008 

0.010 

1.299 

0.199 

0.081 

0.253 

0.113 

0.130 

Cauliflower is classified as major crops in northern Europe and as minor crop in southern Europe. For 

extrapolation to the whole group of flowering brassica, a minimum of 4 trials on cauliflower and 4 trials on 

broccoli are required. 

Hence, the number of application did not have much influence on the resulting residues, the results of the 

residue trials carried out with 3 applications were taking into account for MRL calculation. 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used for 

spirotetramat in flowering brassica (based on data obtained from trials from Northern and Southern Europe): 

MRL-calculation based on data obtained from the Northern Region:

Individual data points for cauliflower are: 

0.22, 0.241, 0.369, 0.427 mg/kg 

Individual data points for broccoli are: 

0.11, 0.308, 0.384, 0.521, 0.578 mg/kg 

Mean residue: 0.351mg/kg; standard deviation: 0.149 mg/kg 

STMR: 0.369 mg/kg 

Highest residue: 0.578 mg/kg 
- 110 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Method I: Rmax = 0.802 mg/kg 

Method II: Rber = 0.948 mg/kg 

Based on the data available for flowering brassica in northern Europe, a MRL of 1 mg/kg can be proposed. 

MRL-calculation based on data obtained from the Southern Region:

Individual data points for cauliflower are: 

0.196, 0.439mg/kg 

Individual data points for broccoli are: 

0.130, 0.260mg/kg 

Mean residue: 0.256 mg/kg; standard deviation: 0.133 mg/kg 

STMR: 0.228 mg/kg 

Highest residue: 0.439 mg/kg 

Method I: Rmax = 0.940 mg/kg 

Method II: Rber = 0.789 mg/kg 

Based on the data available for flowering brassica in southern Europe, a MRL of 1 mg/kg can be proposed. 

Conclusion:

Nearly all residue trials concerning the residue behaviour of spirotetramat in flowering brassica were carried 

out with three applications per season. In the trials from 2005 the first sampling was made directly after the 

2

nd application and three days after the 2nd application. The comparison of the specimens taken after the 2nd

application and the samples 3 days after the 3rd application showed comparable results; therefore the results 

were taken for MRL calculation. Based on the available trials on cauliflower and broccoli a MRL of 1 mg/kg

for flowering brassica can be proposed. 

Comments (RMS):

No comments. 

B.7.6.8.2 Head brassica 

B.7.6.8.2.1 Brussels sprouts 

Spirotetramat is applied for the use in Brussels sprouts in northern Europe against aphids. The critical 

European GAPs are summarised in table B.7.6.8.2.1-1. 

Table B.7.6.8.2.1-1: GAP for residue situation in Brussels sprouts 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 2 Spray BBCH 79 0.072 g a.s./ha 3 

Reference: Determination of the Residues of BYI08330 in/on Brussels Sprouts after 

Spraying of BYI08330 (100 OD) in the Field in Germany and Northern France 

Author(s), year: Freitag T.; Wolters A.; 2005 

Report/Doc. number: RA-2039/04, including trials no. R 2004 0160/4, R 2004 0161/2, R 2004 0162/0, R 

2004 0163/9 

M-260437-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 
- 111 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of the Residues of BYI08330 in/on Brussels Sprouts after 

Spraying of BYI08330 (150 OD) in the Field in Germany, Northern France and 

United Kingdom 

Author(s), year: Freitag T.; Eberhardt R. ; Wolters A.; 2006 

Report/Doc. number: RA-2066/05, including trials no. R 2005 0369/5, R 2005 0370/9, R 2005 0371/7, R 

2005 0372/5 

M-273238-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

In 2004 and 2005, the magnitude of residues of spirotetramat and its metabolites BYI 08330-enol, BYI 

08330-ketohydroxy, BYI 08330-mono-hydroxy and BYI 08330-enol-Glc in/on Brussels sprouts harvested 

following the treatment with BYI 08330 formulations (100 OD, 150 OD) was determined in northern Europe

(Germany, UK and N-France). 

In northern Europe 8 trials on Brussels sprouts were performed using different formulations of spirotetramat 

An overview on the supervised residue trials conducted with different formulations of spirotetramat is given in 

table B.7.6.8.2.1-2. 

Table B.7.6.8.2.1-2: Overview on European residue trials with BYI08330 in Brussels sprouts 

Location Formulation No. of 

trials Year Use rate (g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Field N-EU OD 100 4 2004 72 500 3 7 

Field N-EU OD 150 4 2005 72 500 3 3-10 

In 2004, 3 spray applications of spirotetramat were performed with a spray interval of 7 days. Samples were 

taken before the last application, 0, 3, 7-8, 14 and 21 days after the last application. The notifier stated that 

due to new results from biological trials the critical GAP changed: The number of applications was changed 

from 3 to 2 and the spray interval from 7 days to 14 days. Therefore the residue trials from 2005 were

performed with 3 applications and a spray interval of 14 days. Samples were taken directly after the second 

application, and 3 days later (to cover the use pattern with two applications), before and after the third 

application, 3, 7-8, 14 and 21 days after the last application. To cover the use pattern with two applications 

additional samples were taken directly after the second application and 3 days later. 

The last application was carried out at growth stage BBCH 46 – 49. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 69 to 193 days. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc were determined by HPLC-ESI-MS/MS according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on Brussels sprouts (all metabolites were calculated as 

spirotetramat equivalent). 

The mean procedural recoveries at the fortification levels of 0.01 to 10.0 mg/kg for spirotetramat and its four 

metabolites ranged between 70 and 110 % and RSD was <20%; these results indicate that the methods 

used were suitable for this analysis. 

Findings:

A detailed summary of the residue results is given in Appendix I o. 
- 112 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

All residue trials for the residue behaviour of spirotetramat on Brussels sprouts were carried out with 3 

applications per seasons. Number of applications and different spray intervals in the submitted trials carried 

out in 2004 are not in accordance with the intended use for Brussels sprouts. In the residue trials performed 

in 2005, the first specimens were taken directly after the 2nd application and 3 days later, therefore it was 

possible to compare the residues after three and two applications. 

Neither the number of applications nor the time interval between the applications seemed to have an 

influence on the resulting residues. Residues of total spirotetramat in Brussels sprouts after 3 applications 

ranged between 0.089 and 0.203 mg/kg whereas after 2 applications residues from 0.092 to 0.105 mg/kg 

were detected. An overview on the results of the residue data is summarized in the table below. The residue 

values used for evaluation are marked with bold numbers. 

The total residue of spirotetramat is mainly composed of the enol and the ketohydroxy metabolites. The

parent compound and the enol-glucoside were present at lower amounts. BYI08330-monohydroxy was not 

detected or in traces, only. 

Table B.7.6.8.2.1-3: Overview of European residue data for spirotetramat and its metabolites in 

Brussels sprouts used 3 times with application rates of 0.072 kg a.s./ha (residues are calculated as 

spirotetramat equivalent): 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Field trials – northern Europe 

brussels 

sprouts / 

OD 100 

Hennef 

Germany, 

2004 

sprout 

sprout 

sprout 

sprout 

sprout 

0* 

0 

3 

7 

14 

0.01 

0.03 

0.01 

0.01 

0.01 

0.022 

0.044 

0.041 

0.051 

0.053 

0.012 

0.016 

0.013 

0.025 

0.014 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.08 

0.064 

0.11 

0.084 

0.106 

0.097 

brussels 

sprouts/ OD 

100 

Langenfeld, 

Germany, 

2004 

sprout 

sprout 

sprout 

sprout 

sprout 

0* 

0 

3 

7 

14 

<0.01 

0.01 

0.01 

0.01 

0.01 

0.012 

0.018 

0.021 

0.035 

0.041 

0.012 

0.013 

0.012 

0.018 

0.017 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.061 

0.063 

0.083 

0.088 

brussels 

sprouts/ OD 

100 

Criqubeuf 

sur Seine 

N- France, 

2004 

sprout 

sprout 

sprout 

sprout 

sprout 

sprout 

0* 

0 

3 

8 

14 

21 

0.01 

0.02 

0.01 

<0.01 

<0.01 

<0.01 

0.023 

0.043 

0.039 

0.069 

0.051 

0.051 

0.023 

0.034 

0.025 

0.032 

0.023 

0.016 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.076 

0.117 

0.094 

0.131 

0.104 

0.097 

brussels 

sprouts/ OD 

100 

Fontaine 

L’Etalon 

N-France, 

2004 

sprout 

sprout 

sprout 

sprout 

sprout 

sprout 

0* 

0 

3 

7 

14 

21 

<0.01 

0.01 

0.01 

0.01 

<0.01 

<0.01 

0.042 

0.051 

0.075 

0.099 

0.098 

0.13 

0.014 

0.023 

0.032 

0.045 

0.043 

0.058 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.086 

0.104 

0.137 

0.174 

0.171 

0.218 

brussels 

sprouts / 

OD 150 

WerlWestönnen 

Germany, 

2005 

sprout 

sprout 

sprout 

sprout 

sprout 

sprout 

-14 

-11 

0 

3 

8 

14 

0.01 

0.01 

0.02 

0.01 

<0.01 

<0.01 

0.032 

0.036 

0.049 

0.029 

0.026 

0.024 

0.029 

0.038 

0.039 

0.030 

0.021 

0.019 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.009 

0.011 

0.008 

0.008 

0.008 

0.091 

0.105 

0.131 

0.089 

0.077 

0.073 

brussels 

sprouts / 

OD 150 

Criquebeuf 

sur Seine 

N-France, 

2005 

sprout 

sprout 

sprout 

sprout 

sprout 

sprout 

-14 

-11 

0 

3 

7 

14 

0.01 

0.01 

0.01 

0.01 

<0.01 

0.01 

0.043 

0.041 

0.045 

0.035 

0.041 

0.041 

0.027 

0.023 

0.020 

0.020 

0.017 

0.018 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.008 

0.008 

0.100 

0.094 

0.095 

0.085 

0.088 

0.089 
- 113 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

brussels 

sprouts / 

OD 150 

Bornheim 

Germany, 

2005 

sprout 

sprout 

sprout 

sprout 

sprout 

sprout 

sprout 

sprout 

-14 

-11 

0* 

0 

3 

7 

14 

21 

0.01 

0.01 

0.02 

<0.01 

0.01 

0.01 

0.01 

0.01 

0.030 

0.033 

0.071 

0.057 

0.057 

0.064 

0.064 

0.060 

0.020 

0.025 

0.046 

0.023 

0.046 

0.034 

0.039 

0.027 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

0.012 

0.008 

0.008 

0.008 

<0.008 

0.008 

0.030 

0.080 

0.092 

0.157 

0.110 

0.133 

0.128 

0.133 

0.139 

brussels 

sprouts / 

OD 150 

Saxmundham 

United 

Kingdom, 

2005 

sprout 

sprout 

sprout 

sprout 

sprout 

sprout 

sprout 

sprout 

-15 

-11 

0* 

0 

3 

7 

14 

21 

0.02 

0.01 

0.02 

<0.01 

0.01 

0.01 

0.01 

<0.01 

0.032 

0.033 

0.059 

0.044 

0.053 

0.068 

0.062 

0.065 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

<0.008 

0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.084 

0.075 

0.111 

0.086 

0.095 

0.110 

0.104 

0.107 

Hence, the number of applications did not have much influence on the resulting residues the results of the 

residue trials carried out with 3 applications were taking into account for MRL calculation. 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used for 

spirotetramat in Brussels sprouts (based on data obtained from trials from Northern Europe): 

MRL-calculation based on data obtained from the northern region:

Individual data points for Brussels sprouts are: 

0.088, 0.089, 0.089, 0.106, 0.11, 0.131, 0.139, 0.218 mg/kg 

Mean residue: 0.121 mg/kg; standard deviation: 0.044 

STMR: 0.108 mg/kg 

Highest residue: 0.218 mg/kg 

Method I: Rmax = 0.260 mg/kg 

Method II: Rber = 0.275 mg/kg 

Based on the data available for Brussels sprouts in northern Europe, a MRL of 0.3 mg/kg can be proposed. 

Conclusion:

Brussels sprouts are applied only for the use of spirotetramat in northern Europe. 8 supervised residue trials 

were submitted to support this use. All trials were carried out with 3 applications. In 2005, to cover the GAPs 

with three and four applications, the first sampling was made directly after the second application and the 

next samples were taken three days after the second application (according the intended use). The results 

from these trials are well corresponding to the specimens taken from the other trials carried out with 3 

applications. Therefore the trials conducted with 3 applications were considered in the MRL-calculation. The 

residues of spirotetramat and its metabolites on Brussels sprouts ranged between 0.088 – 0.218 mg/kg. 

The data is sufficient to propose an EU MRL and a MRL of 0.3 mg/kg can be proposed. 

Comments (RMS):

No comments. 

B.7.6.8.2.2 Head cabbage 

Spirotetramat is applied for control of aphids in head cabbage. The critical European GAPs for the 

greenhouse and field uses of spirotetramat on head cabbage are summarised in Table B.7.6.8.2.2-1. 
- 114 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.8.2.2-1: GAP for residue situation in head cabbage 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 2 Spray BBCH 79 0.072 g a.s./ha 3 

EU-S F 2 Spray BBCH 79 0.072 g a.s./ha 3 

Reference: Determination of the Residues of BYI08330 in/on Round Cabbage, Red 

Cabbage and Savoy Cabbage after spraying of BYI08330 (100 OD) in the 

Field in Germany, United Kingdom and Northern France 

Author(s), year: Freitag T.; Wolters A.; 2005 

Report/Doc. number: RA-2037/04, including trials no. R 2004 0152/3, R 2004 0156/6, R 2004 0157/4 

M-260141-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Red Cabbage and Round 

Cabbage after Spraying of BYI08330 (100 OD) in the Field in Spain and Italy 

Author(s), year: Freitag T.; Behn U.; 2005 

Report/Doc. number: RA-2038/04, including trials no. R 2004 0158/2, R 2004 0159/0 

M-260014-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on red cabbage, round 

cabbage and Savoy cabbage after spraying of BYI08330 (150 OD) in the field 

in Northern-France and Germany 

Author(s), year: Ballesteros; Gateaud L.; 2006 

Report/Doc. number: RA-2060/05, including trials no. R 2005 0352/0, R 2005 0353/9, R 2005 0354/7, R 

2005 0355/5, R 2005 0356/3, R 2005 0357/1, R 2005 0359/8 

M-272557-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 
- 115 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of the residues of BYI08330 in/on red cabbage and round 

cabbage after spraying of BYI08330 (150 OD) in the field in Italy and Spain 

Author(s), year: Ballesteros; Gateaud L.; 2006 

Report/Doc. number: RA-2061/05, including trials no. R 2005 0350/4, R 2005 0351/2 

M-272570-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

The magnitude of residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 

08330-mono-hydroxy and BYI 08330-enol-Glc in/on head cabbage following the treatment with BYI 08330 

formulations (100 OD, 150 OD) under field conditions was determined in 2004 and 2005. 10 supervised 

residue trials were performed in northern (Germany, UK and N-France) and 4 trials were carried out in 

southern Europe (Italy, S-France and Spain). 

An overview on the supervised residue trials conducted with different formulations of spirotetramat is given in 

Table B.7.6.8.2.2-2. 

Table B.7.6.8.2.2-2: Overview on European residue trials with BYI08330 in head cabbage 

Location Formulation No. of 

trials Year Use rate (g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Field N-EU OD 100 3 2004 72 500-600 3 6-8 

Field N-EU OD 150 7 2005 72 500-600 2-3 14 

Field S-EU OD 100 2 2004 72 600, 800 3 7 

Field S-EU OD 150 2 2005 72 500-800 3 14-22 

In the residue trials 2004, 3 spray applications of spirotetramat were performed with a spray interval of 7 

days. Samples were taken before the last application, 0, 3, 6-7, 13-14 and 20-23 days after the last 

application. The notifier stated that due to new results from biological trials the critical GAP changed: The 

number of applications was lowered from 3 to 2 and the spray interval extended from 7 days to 14 days. The 

residue trials from 2005 were performed with 3 applications and a spray interval of 14 days. Samples were 

taken 0-21 days after the last application and to cover the use pattern with two applications, additional 

samples were taken directly after the second application and 3 days later. 

The last application was carried out at growth stage BBCH 45 – 49. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 35 to 268 days. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc in red, white and Savoy cabbage were determined by HPLC-ESI-MS/MS 

according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on head cabbages (all metabolites were calculated as

spirotetramat). 

The mean procedural recoveries at the fortification levels of 0.01 to 5.0 mg/kg for spirotetramat and its four 

metabolites ranged between 70 and 110 % and RSD was <20%; these results indicate that the methods 

used were suitable for this analysis. 
- 116 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Findings:

A detailed summary of the residue results is given in Appendix I p. 

The residue trials for the residue behaviour of spirotetramat on red, white and Savoy cabbage were carried 

out with 3 applications per seasons. Number of applications and spray interval (6-8 days instead of 14 days) 

in the submitted trials carried out in 2004 are not in accordance with the intended use for flowering brassica. 

In the residue trials performed in 2005, the first specimens were taken directly after the 2nd application and 3 

days later, therefore it was possible to compare the residues after three and two applications. 

Neither the number of applications nor the time interval between the applications seemed to have an 

influence on the resulting residues. Residues of total spirotetramat in head cabbages after 3 applications 

ranged between 0.067 and 0.261 mg/kg whereas after 2 applications residues between 0.060 and 0.478 

mg/kg were detected. An overview on the results of the residue data is summarized in the table below. The 

residue values used for evaluation are marked with bold numbers. 

The total residue of spirotetramat is mainly composed of the enol and the ketohydroxy metabolites. The

parent compound and the enol-glucoside were present at lower amounts. BYI08330-monohydroxy was not 

detected or in traces, only. 

Table B.7.6.8.2.2-3: Overview of European residue data for spirotetramat and its metabolites in head 

cabbage used 2-3 times with application rates of 0.072 kg a.s./ha (residues are calculated as 

spirotetramat equivalent): 

crop / 

fomulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Field trials – Northern Europe 

round 

cabbage 

OD 100 

Langenfeld, 

Germany, 

2004 

head 

head 

head 

head 

head 

0* 

0 

3 

7 

14 

0.01 

0.13 

0.01 

0.01 

<0.01 

0.024 

0.025 

0.032 

0.037 

0.018 

0.024 

0.022 

0.023 

0.030 

0.025 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.078 

0.197 

0.085 

0.097 

0.073 

red 

cabbage 

OD 100 

Frithville, 

United 

Kingdom, 

2004 

head 

head 

head 

head 

head 

head 

0* 

0 

3 

6 

14 

20 

0.01 

0.04 

0.01 

0.01 

<0.01 

<0.01 

0.065 

0.062 

0.060 

0.059 

0.062 

0.059 

0.013 

0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.108 

0.134 

0.102 

0.101 

0.104 

0.101 

Savoy 

cabbage 

OD 100 

Faverolles 

N-France, 

2004 

head 

head 

head 

head 

head 

head 

0* 

0 

3 

7 

14 

21 

<0.01 

0.04 

0.01 

<0.01 

<0.01 

<0.01 

0.012 

0.045 

0.017 

0.012 

0.012 

0.012 

0.035 

0.070 

0.044 

0.014 

0.012 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.008 

0.008 

0.008 

<0.008 

<0.008 

<0.008 

0.077 

0.175 

0.091 

0.056 

<0.054 

0.055 

red 

cabbage 

OD 150 

Dury 

N-France, 

2005 

head 

head 

head 

head 

head 

head 

head 

head 

-14 

-11 

0* 

0 

3 

7 

14 

21 

<0.01 

0.012 

<0.01 

0.022 

0.010 

<0.01 

<0.01 

<0.01 

0.014 

0.019 

0.014 

0.020 

0.025 

0.025 

0.017 

0.024 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.056 

0.063 

0.056 

0.074 

0.067 

0.067 

0.059 

0.066 

red 

cabbage 

OD 150 

Burscheid 

Germany, 

2005 

head 

head 

head 

head 

head 

head 

-14 

-11 

0 

3 

7 

14 

0.036 

<0.01 

0.038 

<0.01 

<0.01 

<0.01 

0.01 

0.095 

0.11 

0.092 

0.090 

0.072 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.078 

0.137 

0.180 

0.134 

0.132 

0.114 
- 117 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

fomulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

round 

cabbage 

OD 150 

Leichlingen 

Germany, 

2005 

head 

head 

head 

head 

head 

head 

head 

head 

-14 

-11 

0* 

0 

3 

7 

14 

21 

<0.01 

<0.01 

<0.01 

0.057 

0.011 

<0.01 

<0.01 

<0.01 

0.032 

0.052 

0.040 

0.058 

0.061 

0.062 

0.053 

0.037 

0.044 

0.067 

0.071 

0.087 

0.094 

0.093 

0.099 

0.074 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.106 

0.149 

0.141 

0.222 

0.186 

0.185 

0.182 

0.141 

round 

cabbage 

OD 150 

WerlWestönnen 

Germany, 

2005 

head 

head 

head 

head 

head 

head 

-14 

-11 

0 

3 

8 

14 

<0.01 

<0.01 

<0.01 

<0.01<

0.01

<0.01 

0.036 

0.035 

0.037 

0.024 

0.032 

0.026 

0.021 

0.022 

0.021 

0.014 

0.015 

0.013 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.087 

0.087 

0.088 

0.068 

0.077 

0.069 

Savoy 

cabbage 

OD 150 

Leichlingen 

Germany, 

2005 

head 

head 

head 

head 

head 

head 

head 

head 

-14 

-11 

0* 

0 

3 

7 

14 

21 

0.22 

0.091 

<0.01 

0.11 

0.031 

<0.01 

<0.01 

<0.01 

0.11 

0.12 

0.076 

0.093 

0.11 

0.064 

0.081 

0.055 

0.084 

0.11 

0.066 

0.11 

0.10 

0.084 

0.074 

0.068 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.434 

0.341 

0.172 

0.333 

0.261 

0.178 

0.185 

0.153 

savoy 

cabbage 

OD 150 

Ennemain 

N-France, 

2005 

head 

head 

head 

head 

head 

head 

-14 

-11 

0 

3 

7 

14 

<0.01 

0.013 

0.013 

<0.01 

<0.01 

<0.01 

<0.012 

0.015 

0.024 

0.031 

0.026 

0.027 

<0.012 

<0.012 

0.028 

0.031 

0.021 

0.018 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.054 

0.060 

0.085 

0.092 

0.077 

0.075 

savoy 

cabbage 

OD 150 

Burscheid 

Germany, 

2005 

head 

head 

head 

head 

head 

head 

-14 

-11 

0 

3 

7 

14 

0.38 

0.24 

0.30 

<0.01 

<0.01 

<0.01 

0.13 

0.12 

0.10 

0.060 

0.06 

0.042 

0.13 

0.098 

0.081 

0.045 

0.061 

0.054 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.660 

0.478 

0.501 

0.135 

0.151 

0.126 

Field trials – Southern Europe 

red 

cabbage 

OD 100 

Gavá 

(Catalua) 

Spain, 2004 

head 

head 

head 

head 

head 

head 

0* 

0 

3 

7 

14 

23 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.098 

0.11 

0.15 

0.19 

0.17 

0.14 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.008 

<0.008 

<0.008 

<0.008 

0.008 

0.008 

0.140 

0.152 

0.192 

0.232 

0.212 

0.182 

round 

cabbage 

OD 100 

Andria (BA) 

Italy, 2004 

head 

head 

head 

head 

head 

0* 

0 

3 

7 

14 

0.01 

0.07 

0.01 

<0.01 

<0.01 

0.024 

0.039 

0.036 

0.051 

0.065 

0.012 

0.021 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.066 

0.150 

0.078 

0.093 

0.107 

red 

cabbage 

OD 150 

Andria 

Italy, 2005 

head 

head 

head 

head 

head 

head 

head 

head 

-14 

-11 

0* 

0 

3 

7 

14 

21 

0.041 

<0.01 

<0.01 

0.030 

<0.01 

<0.01 

<0.01 

<0.01 

0.036 

0.025 

0.031 

0.047 

0.046 

0.058 

0.062 

0.071 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0,012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.109 

0.067 

0.073 

0.109 

0.088 

0.100 

0.104 

0.113 
- 118 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

fomulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

round 

cabbage 

OD 150 

Gava 

Spain, 2005 

head 

head 

head 

head 

head 

head 

-16 

-13 

0 

2 

7 

14 

0.010 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.019 

0.022 

0.032 

0.029 

0.032 

0.034 

0.020 

0.018 

0.017 

0.017 

0.014 

0.018 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.069 

0.070 

0.079 

0.076 

0.076 

0.082 

Where appropriate the residues from the trials performed in 2005 were taken for MRL calculation, which

were in correspondence with the intended GAP. Hence, the number of application did not have much 

influence on the resulting residues; the results of the residue trials carried out with 3 applications were taking 

into account for MRL calculation too. 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used for 

spirotetramat in head cabbage (based on data obtained from trials from Northern and Southern Europe): 

MRL-calculation based on data obtained from the Northern Region:

Individual data points for head cabbage are: 

0.067, 0.077, 0.091, 0.092, 0.097, 0.104, 0.134, 0.151, 0.186, 0.261 mg/kg 

Mean residue: 0.126 mg/kg; standard deviation: 0.060 mg/kg 

STMR: 0.101 mg/kg 

Highest residue: 0.261 mg/kg 

Method I: Rmax = 0.300 mg/kg 

Method II: Rber = 0.320 mg/kg 

Based on the data available for head cabbage in northern Europe, a MRL of 0.5 mg/kg can be proposed. 

MRL-calculation based on data obtained from the Southern Region:

Individual data points for head cabbage are: 

0.082, 0.107, 0.113, 0.232 mg/kg 

Mean residue: 0.134 mg/kg; standard deviation: 0.067 mg/kg 

STMR: 0.110 mg/kg 

Highest residue: 0.232 mg/kg 

Method I: Rmax = 0.478 mg/kg 

Method II: Rber = 0.405 mg/kg 

Based on the data available for head cabbage in southern Europe, a MRL of 0.5 mg/kg can be proposed. 

Conclusion:

All residue trials concerning the residue behaviour of spirotetramat in head cabbage were carried out with 

three applications per season. In the trials from 2005 the first sampling was made directly after the 2

nd

application and three days after the 2nd application, therewith to applied GAP (2 applications, spray interval 

14 days) was covered by these trials. The comparison of the specimens taken after the 2nd application and 

the samples 3 days after the 3rd application showed comparable results; therefore the results of the 3rd

application were taken for MRL calculation. Based on the available trials on cauliflower and broccoli a MRL 

of 0.5 mg/kg for head cabbage can be proposed. 

Comments (RMS):

No comments. 

B.7.6.8.3 Leafy brassica 

Spirotetramat is applied for control of aphids in leafy brassica. The critical European GAPs for the uses of 

spirotetramat in leafy brassica in northern and southern Europe are summarised in Table B.7.6.8.3-1. 
- 119 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.8.3-1: GAP for residue situation in leafy brassica 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

Mode of 

application 

Growth stage at 

last application 

Application rate expressed 

under the relevant unit 

PHI 

(d) 

EU-N F 3 Spray BBCH 79 0.072 g a.s./ha 3 

EU-S F 3 Spray BBCH 79 0.072 g a.s./ha 3 

Reference: Determination of the residues of BYI08330 in/on curly kale after spraying of 

BYI08330 (100 OD) in the field in United Kingdom and Germany 

Author(s), year: Freitag T.; Eberhardt R.; 2006 

Report/Doc. number: RA-2040/04, including trials no. R 2004 0164/7, R 2004 0165/5 

M-263745-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on curly kale after spraying of 

BYI08330 (150 OD) in the field in Germany 

Author(s), year: Ballesteros C.; Gateaud L.; 2006 

Report/Doc. number: RA-2064/05, including trials no. R 2005 0367/9, R 2005 0368/7 

M-272573-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on Chinese kale after spraying 

of BYI08330 (100 OD) in the field in Southern France and Spain 

Author(s), year: Freitag T.; Eberhardt R.; 2006 

Report/Doc. number: RA-2041/04, including trials no. R 2004 0166/3, R 2004 0167/1 

M-264301-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the residues of BYI08330 in/on Chinese cabbage after 

spraying of BYI08330 (150 OD) in the field in Spain and Italy 

Author(s), year: Ballesteros C.; Gateaud L.; 2006 

Report/Doc. number: RA-2136/05, including trials no. R 2005 0709/7, R 2005 0710/0 

M-273243-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 
- 120 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Experimental design:

The magnitude of residues of spirotetramat and its metabolites in leafy brassica was determined in northern 

(4 trials on curly kale) and southern Europe (2 trials on Chinese kale and 2 trials on Chinese cabbage). 

The supervised residue trials were performed with oil based dispersion concentrate containing 100 and 150 

g a.s./L respectively and were carried out in Germany, United Kingdom, southern France, Italy and Spain in 

2004 and 2005. In deviation to the intended GAP, the residue trials from 2004 were conducted with a spray 

interval of 7 days. According to the critical European GAP residue data from day 3 after 3 applications were 

evaluated. If the total residue at later intervals exceeded the residue at day 3, residues at later intervals were 

evaluated to cover the worst case. 

An overview on the supervised residue trials conducted with different formulations of spirotetramat is given in 

Table B.7.6.8.3-2. 

Table B.7.6.8.3-2: Overview on European residue trials with BYI08330 in leafy brassica 

Location Formulation No. of 

trials Year Use rate (g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Field N-EU OD 100 2 2004 72 500 3 6-7 

Field N-EU OD 150 2 2005 72 500-600 3 14 

Field S-EU OD 100 2 2004 72-76 600-633 3 6-8 

Field S-EU OD 150 2 2005 66-72 552-1500 3 14 

In 2004, samples were taken directly before and after the last application, 2-4, 7, 13-14 and 21 days after the 

last application. In 2005 the first sampling was done directly after the second application and 3 days later, 

before and after the third application and 2-3, 7, 14 and 21 days after the last application. 

The last application was carried out at growth stage BBCH 43 – 78. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 106 to 232 days. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc in kale and Chinese cabbage were determined by HPLC-ESI-MS/MS 

according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on leafy brassica (all metabolites were calculated as 

spirotetramat). 

The mean procedural recoveries at the fortification levels of 0.01 to 10.0 mg/kg for spirotetramat and its four 

metabolites ranged between 70 and 110 % and RSD was <20%; these results indicate that the methods 

used were suitable for this analysis. 

Findings:

A detailed summary of the residue results is given in Appendix I q. 

The total residues of spirotetramat in leafy brassica (curly kale) grown in northern Europe (4 trials) ranged 

between 0.240 and 0.765 mg/kg. In leafy brassica (Chinese kale and Chinese cabbage) from 4 field trials in 

southern Europe a total residue of 0.212 to 0.631 mg/kg could be determined. In all residue trials the number 

of applications and the application rates were performed according to the European GAP. In the residue

trials from 2004, the application interval was 7 days. There was no significant difference in the residues 

neither from the different spray intervals nor the different varieties nor growing areas. 

An overview on the results of the residue data is summarized in the table below. The residue values used for 

evaluation are marked with bold numbers. 

The total residue of spirotetramat is mainly composed of spirotetramat, the -enol and the -ketohydroxy

metabolite. BYI08330-monohydroxy and enol-glucoside were not found or in traces, only 
- 121 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.8.3-3: Overview of European residue data for spirotetramat and its metabolites in leafy 

brassica used 3 times with application rates of 0.072 kg a.s./ha (residues are calculated as 

spirotetramat equivalent): 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Field trials – Northern Europe 

curly Kale / 

100 OD 

Cambridge 

United 

Kingdom, 

2004 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

0* 

0 

3 

8 

15 

0.40 

1.2 

0.15 

0.20 

0.07 

0.33 

0.42 

0.22 

0.29 

0.28 

0.12 

0.24 

0.081 

0.11 

0.080 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.008 

0.008 

0.008 

0.012 

0.870 

1.880 

0.471 

0.620 

0.454 

curly Kale / 

100 OD 

Monheim 

Germany, 

2004 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

-1 

0 

3 

7 

14 

20 

0.08 

1.0 

0.50 

0.07 

0.05 

0.03 

0.070 

0.23 

0.12 

0.053 

0.050 

0.041 

0.094 

0.18 

0.12 

0.064 

0.048 

0.037 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.014 

0.013 

0.015 

0.020 

0.018 

0.268 

1.436 

0.765 

0.214 

0.180 

0.138 

curly Kale / 

150 OD 

Monheim 

Germany, 

2005 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

-14 

-11 

0* 

0 

3 

7 

14 

21 

1.2 

0.90 

0.0450

0.87 

0.086 

0.046 

0.029 

0.010 

0.15 

0.079 

0.059 

0.21 

0.092 

0.061 

0.062 

0.038 

0.055 

0.072 

0.019 

0.053 

0.042 

0.033 

0.021 

0.014 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.010 

<0.008 

1.425 

1.071 

0.143 

1.153 

0.240 

0.160 

0.134 

0.082 

curly Kale / 

150 OD 

Burscheid 

Germany, 

2005 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

-14 

-11 

0 

3 

7 

14 

1.1 

0.91 

1.1 

0.029 

0.020 

0.019 

0.18 

0.18 

0.28 

0.16 

0.21 

0.12 

0.051 

0.072 

0.075 

0.035 

0.051 

0.022 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

1.351 

1.182 

1.475 

0.244 

0.301 

0.181 

Field trials – Southern Europe 

Chinese 

kale / 

100 OD 

Ouzilly 

France, 

2004 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

0 

3 

7 

14 

0.38 

0.11 

0.01 

<0.01 

0.37 

0.28 

0.19 

0.15 

0.11 

0.12 

0.056 

0.046 

<0.012 

<0.012 

<0.012 

<0.012 

0.029 

0.034 

0.037 

0.039 

0.901 

0.556 

0.305 

0.257 

Chinese 

kale / 

100 OD 

Gava 

Spain, 2004 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

leaf, n. 

0* 

0 

4 

7 

14 

20 

0.10 

0.47 

0.08 

0.07 

<0.01 

<0.01 

0.28 

0.50 

0.38 

0.31 

0.38 

0.25 

0.099 

0.18 

0.12 

0.11 

0.16 

0.11 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.043 

0.054 

0.039 

0.043 

0.028 

0.030 

0.534 

1.216 

0.631 

0.545 

0.590 

0.412 

Chinese 

cabbage / 

150 OD 

Gava 

Spain, 2005 

head 

head 

head 

head 

head 

head 

head 

-14 

-12 

0 

2 

7 

14 

21 

0.94 

0.28 

<0.01 

<0.01 

<0.01 

<0.01<

0.01 

0.72 

0.49 

0.12 

0.19 

0.16 

0.082 

0.060 

0.13 

0.15 

0.047 

0.069 

0.12 

0.068 

0.055 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

1.810 

0.940 

0.197 

0.289 

0.310 

0.180 

0.145 

Chinese 

cabbage / 

150 OD 

Andria 

Italy, 2005 

head 

head 

head 

head 

head 

head 

head 

head 

-14 

-11 

0* 

0 

3 

7 

14 

21 

0.048 

<0.01 

<0.01 

0.020 

<0.01 

<0.01 

<0.01 

<0.01 

0.11 

0.16 

0.11 

0.11 

0.13 

0.15 

0.13 

0.13 

0.033 

0.028 

0.021 

0.029 

0.026 

0.032 

0.026 

0.035 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

<0.008 

0.211 

0.218 

0.161 

0.179 

0.186 

0.212 

0.186 

0.195 

leaf, n. = leaf, normal 
- 122 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Leafy brassica is classified as minor crops in northern and southern Europe. For extrapolation to the whole 

group of leafy brassica, a minimum of 4 trials on kale are required. 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used for 

spirotetramat in leafy brassica (based on data obtained from trials from northern and southern Europe): 

MRL-calculation based on data obtained from the Northern Region:

Individual data points for curly kale are: 

0.240, 0.301, 0.620, 0.765 mg/kg 

Mean residue: 0.482 mg/kg; standard deviation: 0.252 mg/kg 

STMR: 0.461 mg/kg 

Highest residue: 0.765 mg/kg 

Method I: Rmax = 1.778 mg/kg 

Method II: Rber = 1.458 mg/kg 

Based on the data available for leafy brassica in northern Europe, a MRL of 2 mg/kg can be proposed. 

MRL-calculation based on data obtained from the Southern Region:

Individual data points for Chinese kale are: 

0.556, 0.631 mg/kg 

Individual data points for Chinese cabbage are: 

0.212, 0.310 mg/kg 

Mean residue: 0.427 mg/kg; standard deviation: 0.198 mg/kg 

STMR: 0.433 mg/kg 

Highest residue: 0.631 mg/kg 

Method I: Rmax = 1.448 mg/kg 

Method II: Rber = 1.225 mg/kg 

Based on the data available for leafy brassica in southern Europe, a MRL of 2 mg/kg can be proposed. 

Conclusion:

In 2004 and 2005, altogether 8 residue trials in Northern and Southern Europe were carried out. Apart from 

the spray interval, all trials were carried out according the intended use parameters and were performed as 

residue decline studies. There was no difference in residues of total spirotetramat in leafy brassica grown in 

northern or southern Europe. Based on the submitted supervised residue trials a MRL of 2 mg/kg can be 

proposed. 

Comments (RMS):

No comments. 

B.7.6.8.4 Kohlrabi 

Spirotetramat is applied for the use in kohlrabi in northern Europe against aphids. The critical European 

GAPs are summarised in table B.7.6.8.4-1. 

Table B.7.6.8.4-1: GAP for residue situation in kohlrabi 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

spray 

interval 

Mode of 

application 

Growth stage at 

last application 

Application 

rate 

PHI 

(d) 

EU-N F 2 14 days Spray BBCH 79 72 g a.s./ha 3 
- 123 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Reference: Determination of the Residues of BYI08330 in/on Kohlrabi after Spraying of 

BYI08330 (100 OD) in the Field in Germany and the Netherlands 

Author(s), year: Freitag T.; Eberhardt R.; 2006 

Report/Doc. number: RA-2043/04, including trials no. R 2004 0169/8, R 2004 0170/1 

M-265036-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Kohlrabi after Spraying of 

BYI08330 (150 OD) in the Field in Germany 

Author(s), year: Freitag T.; Eberhardt R.; 2006 

Report/Doc. number: RA-2065/05, including trials no. R 2005 0373/3, R 2005 0374/1 

M-272128-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

The magnitude of residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 

08330-mono-hydroxy and BYI 08330-enol-Glc in/on kohlrabi harvested following the treatment with 

spirotetramat formulations (100 OD, 150 OD) was determined in northern Europe (Germany and The 

Netherlands) in 2004 and 2005. 

In northern Europe 4 trials on kohlrabi were performed using different formulations of spirotetramat. An 

overview on the supervised residue trials conducted with different formulations of spirotetramat is given in 

table B.7.6.8.4-2. 

Table B.7.6.8.4-2: Overview on European residue trials with spirotetramat in kohlrabi 

Location Formulation No. of 

trials Year Use rate (g as/ha) Water volume No of appl. 

Spray interval 

(days) 

Field N-EU OD 100 2 2004 72 400, 600 L/ha 3 7-8 

Field N-EU OD 150 2 2005 72 600, 1000 L/ha 3 14-15 

In 2004, the residue trials were carried out with 3 spray applications of spirotetramat and a spray interval of 7 

days. Samples of leaves and the corm were taken before and after the last application, 0, 3, 7, 14 and 21 

days after the last application. The notifier stated that due to new results from biological trials the critical GAP 

changed: The number of applications was changed from 3 to 2 and the spray interval from 7 days to 14 days. 

Therefore the residue trials from 2005 were performed with 3 applications and a spray interval of 14 days. 

Samples were taken directly after the second application, and 3 days later (to cover the use pattern with two 

applications), before and after the third application, 3, 7, 14 and 21 days after the last application. 

The last application was carried out at growth stage BBCH 17 – 47. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 173 to 463 days. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc were determined by HPLC-ESI-MS/MS according to method 00857. 
- 124 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on kohlrabi leaves and corm (all metabolites were 

calculated as spirotetramat equivalent). 

The mean procedural recoveries at the fortification levels of 0.01 to 10.0 mg/kg for spirotetramat and its four 

metabolites ranged between 70 and 110 % and RSD was <20%; these results indicate that the methods 

used were suitable for this analysis. 

Findings:

A detailed summary of the residue results is given in Appendix I r. 

All residue trials for the residue behaviour of spirotetramat on kohlrabi were carried out with 3 applications 

per seasons. The number of applications and different spray intervals in the submitted trials carried out in 

2004 are not fully in accordance with the intended use for kohlrabi. In the residue trials performed in 2005, 

the first specimens were taken directly after the 2nd application and 3 days later, therefore it was possible to 

compare the residues after three and two applications. 

Neither the number of applications nor the time interval between the applications seemed to have an 

influence on the resulting residues. Residues of total spirotetramat in kohlrabi after 3 applications ranged 

between 0.152 and 0.670 mg/kg whereas after 2 applications residues of 0.204 and 0.267 mg/kg were 

detected. An overview on the results of the residue data is summarized in the table below. The residue

values used for evaluation are marked with bold numbers. 

The total residue of spirotetramat in kohlrabi corm is mainly composed of the -enol and the ketohydroxy 

metabolites. The parent compound and the enol-glucoside were present at lower amounts. BYI08330-

monohydroxy was not detected or in traces, only. 

Table B.7.6.8.2.2-3: Overview of northern European residue data for spirotetramat and its metabolites 

in kohlrabi used 3 times with application rates of 0.072 kg a.s./ha: 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

kohlrabi / 

OD 100 

WerlWestönnen 

Germany, 

2004 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n.

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

0* 

0* 

0 

0 

3 

3 

7 

7 

14 

14 

21 

21 

0.01 

0.04 

0.03 

1.2 

0.01 

0.66 

0.01 

0.06 

<0.01 

<0.01 

<0.01 

<0.01 

0.42 

0.41 

0.55 

2.1 

0.52 

1.2 

0.51 

0.73 

0.33 

0.10 

0.13 

0.023 

0.064 

0.11 

0.11 

0.48 

0.12 

0.29 

0.083 

0.14 

0.020 

0.032 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

0.021 

0.008 

0.023 

0.008 

0.027 

<0.008 

0.028 

<0.008 

0.017 

<0.008 

0.014 

0.514 

0.593 

0.710 

3.815 

0.670 

2.189 

0.623 

0.970 

0.380 

0.171 

0.172 

0.071 

kohlrabi / 

OD 100 

ZwaagdijkOost 

Netherlands

, 2004 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n.

corm 

leaf, n. 

corm 

leaf, n. 

0* 

0* 

0 

0 

3 

3 

7 

7 

14 

14 

21 

21 

<0.01 

0.08 

0.01 

1.5 

0.01 

0.91 

<0.01 

0.49 

<0.01 

0.05 

<0.01 

0.01 

0.37 

0.10 

0.42 

0.62 

0.42 

0.35 

0.49 

0.16 

0.28 

0.041 

0.20 

0.041 

0.032 

0.038 

0.038 

0.21 

0.033 

0.097 

0.034 

0.059 

0.018 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012<

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012<

0.012 

<0.008 

0.033 

<0.008 

0.042 

<0.008 

0.042 

0.008 

0.056 

0.008 

0.067 

<0.008 

0.061 

0.432 

0.263 

0.488 

2.384 

0.483 

1.411 

0.554 

0.777 

0.328 

0.182 

0.242 

0.136 
- 125 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

kohlrabi / 

OD 150 

LangenfeldReusrath 

Germany, 

2005 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

-14 

-14 

-11 

-11 

0* 

0* 

0 

0 

3 

3 

7 

7 

14 

14 

21 

21 

0.01 

0.57 

0.01 

0.12 

0.01 

1.1 

0.01 

1.3 

0.01 

0.08 

0.01 

0.10 

<0.01 

0.02 

<0.01 

0.01 

0.096 

0.87 

0.22 

0.18 

0.15 

0.42 

0.13 

0.41 

0.19 

0.14 

0.15 

0.032 

0.094 

0.012 

0.045 

0.012 

0.013 

0.28 

0.017 

0.062 

0.013 

0.11 

0.013 

0.12 

0.012 

0.044 

0.012 

<0.012 

0.012 

<0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.008 

0.022 

<0.008 

0.025 

<0.008 

0.022 

<0.008 

0.022 

<0.008 

0.038 

<0.008 

0.040 

<0.008 

0.032 

<0.008 

0.029 

0.139 

1.754 

0.267 

0.399 

0.193 

1.664 

0.173 

1.864 

0.232 

0.314 

0.192 

0.196 

0.136 

0.088 

0.087 

0.075 

kohlrabi / 

OD 150 

Burscheid 

Germany, 

2005 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

corm 

leaf, n. 

-14 

-14 

-11 

-11 

0* 

0* 

0 

0 

3 

3 

7 

7 

14 

14 

0.03 

1.3 

0.01 

0.38 

0.02 

0.77 

0.01 

0.03 

<0.01 

0.01 

<0.01 

0.01 

<0.01 

<0.01 

0.18 

0.38 

0.16 

0.17 

0.13 

0.24 

0.11 

0.027 

0.11 

0.074 

0.088 

0.045 

0.068 

0.023 

0.015 

0.044 

0.014 

0.025 

0.012 

0.034 

0.012 

0.012 

0.012 

0.014 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012<

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

0.038 

0.008 

0.044 

0.008 

0.054 

<0.008 

0.048 

<0.008 

0.062 

<0.008 

0.057 

<0.008 

0.052 

0.245 

1.774 

0.204 

0.631 

0.182 

1.11 

0.152 

0.129 

0.152 

0.172 

0.13 

0.136 

0.110 

0.109 

leaf, n. leaf, normal 

Hence, the number of application did not have much influence on the resulting residues the results of the 

residue trials carried out with 3 applications were taking into account for MRL calculation too. 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used for 

spirotetramat in kohlrabi (based on data obtained from trials from Northern Europe): 

MRL-calculation based on data obtained from the northern region:

Individual data points for kohlrabi are: 

0.152, 0.232, 0.554, 0.670 mg/kg 

Mean residue: 0.402 mg/kg; standard deviation: 0.249 

STMR: 0.393 mg/kg 

Highest residue: 0.670 mg/kg 

Method I: Rmax = 1.684 mg/kg 

Method II: Rber = 1.282 mg/kg 

Based on the data available for kohlrabi in northern Europe, a MRL of 2 mg/kg can be proposed. 

Conclusion:

Kohlrabi is applied for the use of spirotetramat in northern Europe. 4 supervised residue trials were submitted 

to support this use. All trials were carried out with 3 applications. In 2005, the first sampling was made 

directly after the second application and the next samples were taken three days after the second 

application, to cover the GAPs with two and three applications (according the intended use). The results from 

these trials are well corresponding to those from the other trials carried out with 3 applications. Therefore the 
- 126 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

trials conducted with 3 applications were considered in the MRL-calculation. The residues of spirotetramat 

and its metabolites on kohlrabi ranged between 0.152 – 0.670 mg/kg. 

The data is sufficient to propose an EU MRL (based on N-EU data) and a MRL of 2 mg/kg can be proposed. 

Comments (RMS):

No comments. 

B.7.6.9 Green bean (fresh, with pods) 

Spirotetramat is applied for control of aphids, white flies and mites on bean and pea plants. The critical 

European GAP for the uses of spirotetramat on green beans in glasshouse is summarised in table B.7.6.9-1. 

Table B.7.6.9-1: GAP for residue situation in green beans 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

spray 

interval 

Mode of 

application 

Growth stage at 

last application 

Application 

rate 

PHI 

(d) 

EU-N/S G 4 7 days Spray BBCH 87 0.072 g a.s. / 

ha and m leafy 

surface* 

14 

Reference: Determination of the residues of BYI08330 in/on climbing French bean after 

spraying of BYI08330 (100 OD) in the greenhouse in Italy, Germany and 

Southern France 

Author(s), year: Schöning R.; Wolters A.; 2006 

Report/Doc. number: RA-2042/04, including trials no. R 2004 0172/8, R 2004 0173/6, R 2004 0174/4, R 

2004 0175/2, R 2004 0176/0, R 2004 0177/9, R 2004 0178/7, R 2004 0179/5 

M-263646-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

The magnitude of residues of spirotetramat and its metabolites in green beans was determined in northern 

and southern Europe for the protected use in glasshouses. 

In 2004, the supervised residue trials carried out in Germany, southern France, Italy and Spain were 

performed on climbing French beans with oil based dispersion concentrate containing 100 g a.s./L . The

trials were conducted in accordance to the critical European GAP. The application of 72 g as/ha and m plant 

height (plants height: 1.2 m - 2 m) resulted in application rates of 86.4 - 144 g a.s./ha. 

An overview on the supervised residue trials conducted with different formulations of spirotetramat is given in 

Table B.7.6.9-2. 

Table B.7.6.9-2: Overview on European residue trials with spirotetramat in green beans 

Location Formulation No. of 

trials Year Use rate (g as/ha)* Water volume* No of appl. 

Spray interval 

(days) 

Field N/S-EU OD 100 8 2004 72 500 4 14-21 

* the application rate is adapted to the height of the leafy surface 

Samples were taken directly before and after the last application, 7, 10, 14 and 21 days after the last 

application. 

The last application was carried out at growth stage BBCH 71 – 79. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 163 to 268 days. 
- 127 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc in climbing French beans with pods were determined by HPLC-ESI-MS/MS 

according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.01 mg/kg for 

spirotetramat, 0.012 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.008 mg/kg for BYI 08330-enol-Glc in/on beans with pods (all metabolites were calculated as 

spirotetramat equivalent). 

The mean procedural recoveries at the fortification levels of 0.01 to 10.0 mg/kg for spirotetramat and its four 

metabolites ranged between 70 and 110 % and RSD was <20%; these results indicate that the methods 

used were suitable for this analysis. 

Findings:

A detailed summary of the residue results is given in Appendix I s. 

The total residues of spirotetramat in green beans with pods grown in European glasshouses ranged 

between 0.082 and 0.624 mg/kg. 

An overview on the results of the residue data is summarized in the table below. The residue values used for 

evaluation are marked with bold numbers. 

Table B.7.6.9-3: Overview of European residue data for spirotetramat and its metabolites in green 

beans used 4 times with application rates of 0.072 kg a.s./ha and m leafy surface; formulation OD100: 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Field trials – glasshouse 

climbing 

French 

bean 

Palidoro 

Fiumicino 

Italy, 2004 

bean w.p 

bean w.p 

bean w.p. 

bean w.p. 

bean w.p. 

bean w.p. 

0* 

0 

7 

10 

14 

21 

0.03 

0.24 

0.13 

0.06 

0.06 

0.04 

0.17 

0.26 

0.25 

0.11 

0.12 

0.063 

0.19 

0.22 

0.20 

0.12 

0.081 

0.042 

<0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.024 

0.030 

0.038 

0.025 

0.030 

0.023 

0.426 

0.762 

0.630 

0.327 

0.303 

0.180 

climbing 

French 

bean 

Manfredonia

Italy, 2004 

bean w.p 

bean w.p 

bean w.p. 

bean w.p. 

bean w.p. 

bean w.p. 

0* 

0 

7 

10 

14 

21 

0.19 

0.42 

0.52 

0.28 

0.01 

0.01 

0.25 

0.46 

0.34 

0.25 

0.066 

0.036 

0.077 

0.12 

0.089 

0.076 

0.020 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.021 

0.025 

0.035 

0.029 

0.008 

0.008 

0.550 

1.037 

0.996 

0.647 

0.116 

0.0780 

climbing 

French 

bean 

Langenfeld 

Germany, 

2004 

bean w.p 

bean w.p 

bean w.p. 

bean w.p. 

bean w.p. 

bean w.p. 

0* 

0 

7 

10 

14 

21 

0.16 

0.20 

0.15 

0.04 

0.13 

0.03 

0.23 

0.22 

0.27 

0.23 

0.29 

0.19 

0.11 

0.13 

0.12 

0.099 

0.099 

0.055 

<0.012 

<0.012 

0.012 

0.012 

0.012 

0.012 

0.018 

0.018 

0.026 

0.021 

0.035 

0.032 

0.530 

0.580 

0.578 

0.402 

0.566 

0.319 

climbing 

French 

bean 

Rognonas 

S-France, 

2004 

bean w.p 

bean w.p 

bean w.p. 

bean w.p. 

bean w.p. 

bean w.p. 

0* 

0 

7 

10 

14 

21 

0.10 

0.28 

0.22 

0.35 

0.15 

0.04 

0.088 

0.15 

0.24 

0.28 

0.26 

0.19 

0.16 

0.21 

0.17 

0.10 

0.099 

0.080 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.024 

0.025 

0.033 

0.040 

0.043 

0.054 

0.384 

0.677 

0.675 

0.782 

0.564 

0.376 

climbing 

French 

bean 

FurbaraCerveteri 

Italy, 2004 

bean w.p 

bean w.p 

bean w.p. 

bean w.p. 

bean w.p. 

bean w.p. 

0* 

0 

7 

10 

14 

21 

0.01 

0.04 

0.01 

0.01 

0.01 

<0.01 

0.041 

0.054 

0.049 

0.031 

0.015 

<0.012 

0.10 

0.10 

0.11 

0.070 

0.037 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.009 

0.010 

0.014 

0.012 

0.008 

<0.008 

0.172 

0.216 

0.195 

0.135 

0.082 

0.054 
- 128 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

climbing 

French 

bean 

Molfetta 

Italy, 2004 

bean w.p 

bean w.p 

bean w.p. 

bean w.p. 

bean w.p. 

bean w.p. 

0* 

0 

7 

10 

14 

21 

0.01 

0.08 

0.02 

0.01 

0.01 

<0.01 

0.037 

0.082 

0.068 

0.046 

0.090 

0.026 

0.084 

0.20 

0.14 

0.075 

0.084 

0.023 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.009 

0.009 

0.012 

0.009 

0.012 

0.008 

0.152 

0.383 

0.252 

0.152 

0.208 

0.079 

climbing 

French 

bean 

Noves 

S-France, 

2004 

bean w.p 

bean w.p 

bean w.p. 

bean w.p. 

bean w.p. 

bean w.p. 

0* 

0 

7 

10 

14 

21 

0.06 

0.13 

0.08 

0.13 

0.11 

0.13 

0.10 

0.13 

0.22 

0.26 

0.27 

0.29 

0.14 

0.17 

0.16 

0.11 

0.12 

0.12 

0.012 

0.012 

0.012 

0.012 

0.012 

0.017 

0.020 

0.020 

0.027 

0.031 

0.043 

0.067 

0.332 

0.462 

0.499 

0.543 

0.555 

0.624 

climbing 

French 

bean 

Langenfeld 

Germany, 

2004 

bean w.p 

bean w.p 

bean w.p. 

bean w.p. 

bean w.p. 

bean w.p. 

0* 

0 

7 

10 

14 

21 

0.02 

0.09 

0.06 

0.07 

0.04 

0.02 

0.23 

0.26 

0.40 

0.36 

0.23 

0.15 

0.16 

0.14 

0.11 

0.13 

0.098 

0.061 

0.012 

<0.012 

0.012 

0.012 

<0.012 

<0.012 

0.012 

0.012 

0.023 

0.022 

0.021 

0.015 

0.434 

0.514 

0.605 

0.594 

0.401 

0.258 

* Before the last treatment 

** Residues of each analyte calculated as spirotetramat (BYI 08330) 

bean w.p. bean with pod 

The total residue of spirotetramat in green beans is mainly composed of spirotetramat, the enol and the 

ketohydroxy metabolites. BYI 08330 monohydroxy and enol-glucoside were not detected or in traces, only. 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used for 

spirotetramat in green beans (based on data obtained from glasshouse trials from northern and southern

Europe): 

MRL-calculation based on data obtained from the glasshouse trials:

Individual data points for green beans are: 

0.082, 0.116, 0.208, 0.303, 0.401, 0.564, 0.566, 0.624 mg/kg 

Mean residue: 0.358 mg/kg; standard deviation: 0.213 mg/kg 

STMR: 0.352 mg/kg 

Highest residue: 0.624 mg/kg 

Method I: Rmax = 1.038 mg/kg 

Method II: Rber = 1.131 mg/kg 

Based on the data available for green beans cultivated in glasshouses, a MRL of 2 mg/kg can be proposed. 

Conclusion:

In 2004, 8 supervised residue glasshouse trials in Northern and Southern Europe were carried out. All trials 

were conducted according the intended GAP. Based on the submitted supervised residue trials a MRL of 2 

mg/kg can be proposed. 

Comments (RMS):

No comments. 

B.7.6.10 Hops 

Spirotetramat is applied for control of aphids, scales and mites in hops. The critical European GAP for the 

uses of spirotetramat on hop from northern Europe is summarised in table B.7.6.10-1. 
- 129 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.10-1: GAP for residue situation in hops 

North or 

South of EU 

Indoor or 

outdoor 

Number of 

applications 

spray 

interval 

Mode of 

application 

Growth stage at 

last application 

Application 

rate 

PHI 

(d) 

EU-N F 1 n.a. Spray BBCH 75 150 g a.s./ha 14 

n.a. not applicable 

Reference: Determination of the Residues of BYI08330 in/on Hop after Spraying of 

BYI08330 (100 OD) in the Field in Northern France and Germany 

Author(s), year: Schöning R.; Helfrich P.; 2006 

Report/Doc. number: RA-2036/04, including trials no. R 2004 0148/5, R 2004 0149/3, R 2004 0150/7, R 

2004 0151/5 

M-265047-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Reference: Determination of the Residues of BYI08330 in/on Hop after Spraying of 

BYI08330 (150 OD) in the Field in Germany and Northern France 

Author(s), year: Schöning R.; 2006 

Report/Doc. number: RA-2108/05, including trials no. R 2005 0550/7, R 2005 0551/5, R 2005 0552/3, R 

2005 0553/1 

M-272100-01-1 

Guideline(s): EU Council Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, 

section 8 residues in or on treated products, food and feed 

GLP: Yes 

Deviations: No 

Validity: Yes 

Experimental design:

The magnitude of residues of spirotetramat and its metabolites on hops was determined in northern Europe 

in 2004 and 2005. The supervised residue trials on hop, carried out in Germany and northern France were 

performed with oil based dispersion concentrates containing 100 and 150 g a.s./L respectively. In 2004, all 

trials were conducted with 2 applications and an application rate of 175 g a.s./ha, the spray interval was 13-

15 days. Due to new result from biological trials the GAP for the use of spirotetramat in hops was changed 

from two applications of 175 g as/ha to one application of 150 g as/ha. Hence residue trials in 2005 were 

conducted according to the new critical European GAP. 

An overview on the supervised residue trials conducted with different formulations of spirotetramat is given in 

Table B.7.6.10-2. 

Table B.7.6.10-2: Overview on European residue trials with spirotetramat on hop 

Location Formulation No. of 

trials Year Use rate (g as/ha)* Water volume* No of appl. 

Spray interval 

(days) 

Field N -EU OD 100 4 2004 175 2200-2500 2 13-15 

Field N -EU OD 150 4 2005 150 2000-2200 1 n.a. 

n.a. not applicable 

Samples of green cones were taken after the last application, 7-8, 13-15, 20-22 and 28-29 days after the last 

application; at the trials from 2004 in addition samples directly before the 2nd application were taken. Except 

on day 0, cones were kiln-dried until approx 10% remaining moisture directly after sampling for laboratory 

sample. 
- 130 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The last application was carried out at growth stage BBCH 72 – 86. 

All samples were stored deep frozen within 24 hours after sampling. The time intervals between date of

deep-freezing and the last extraction ranged from 125 to 366 days. 

Analytical method used in all studies:

Residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and BYI 08330-enol-Glc in green and kiln-dried hops cons were determined by HPLC-ESI-MS/MS 

according to method 00857. 

The limit of quantification (LOQ, defined as the lowest validated fortification level) was 0.1 mg/kg for 

spirotetramat, 0.12 mg/kg for its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy and 0.08 mg/kg for BYI 08330-enol-Glc in/on green and kiln-dried cone (all metabolites were 

calculated as spirotetramat equivalent). 

The mean procedural recoveries at the fortification levels of 0.1 to 10.0 mg/kg for spirotetramat and its four 

metabolites ranged between 70 and 110 % and RSD was <20%; these results indicate that the methods 

used were suitable for this analysis. 

Findings:

A detailed summary of the residue results is given in Appendix I t. 

The supervised residue trials in 2004 were performed with 2 applications in stead of 1 application only; 

therefore, these trials were not conducted according to the intended GAP. The residue data on green cones 

obtained from residue trials carried out in 2004 residue data are available for samples collected 14 days after 

the first application, but these specimens were not further kiln-dried. The residues of total spirotetramat in 

green cones after one application ranged between 0.54 and 0.90 mg/kg whereas after 2 applications 

residues between 0.60 and 1.20 mg/kg were detected. Therefore, the number of applications seemed to 

have no significant influence on the resulting residues. 

In 2004 the application rate of spirotetramat was 175 g as/ha exceeding the application rate of the critical 

European GAP by 17%. The divergence between the application rates is within the 25 % tolerance according 

to the guideline (SANCO Document 7525/VI/95 rev.7) and is regarded as acceptable. 

An overview on the results of the residue data is summarized in the table below. The residue values used for 

evaluation are marked with bold numbers. 

Table B.7.6.10-3: Overview of European residue data for spirotetramat and its metabolites in green 

and kiln-dried cones used 1-2 times with application rates of 0.175-150 kg a.s./ha (residues are 

calculated as spirotetramat equivalent): 

crop / 

No of appl./ 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

Field trials – Northern Europe 

hop 

2 appl. 

OD 100 

Schleithal 

N-France, 

2004 

cone, g. 

cone, g. 

cone, g. 

cone, KD 

cone, g. 

cone, KD 

cone, g 

cone, KD 

0* 

0 

8 

8 

14 

14 

22 

22 

0.40 

0.58 

0.11 

0.24 

0.17 

0.63 

0.10 

0.52 

<0.12 

0.18 

<0.12 

0.23 

<0.12 

0.18 

<0.12 

0.15 

<0.12 

<0.12 

<0.12 

0.19 

<0.12 

0.30 

<0.12 

0.19 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

0.14 

0.31 

0.09 

0.27 

0.13 

0.41 

0.09 

0.43 

0.90 

1.31 

0.56 

1.05 

0.66 

1.64 

0.55 

1.41 

hop 

2 appl. 

OD 100 

Gebrontshausen 

Germany, 

2004 

cone,g. 

cone, g. 

cone, g. 

cone, KD 

cone, g. 

cone, KD 

cone g. 

cone, KD 

0* 

0 

7 

7 

14 

14 

22 

22 

0.21 

1.50 

0.25 

1.7 

0.27 

0.56 

0.26 

0.94 

<0.12 

0.67 

0.21 

0.97 

<0.12 

0.25 

<0.12 

0.35 

<0.12 

0.27 

0.23 

1.0 

0.17 

0.39 

0.15 

0.51 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

0.14 

0.19 

0.25 

1.0 

0.21 

0.50 

0.23 

0.70 

0.71 

2.75 

1.06 

4.79 

0.89 

1.82 

0.88 

2.62 
- 131 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

crop / 

No of appl./ 

formulation 

Location, 

year 

portion DAT 

[days] 

BYI 

08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total 

residues 

of BYI 

08330 

hop 

2 appl. 

OD 100 

Tettnang 

Germany, 

2004 

cone, g. 

cone g. 

cone, g. 

cone, KD 

cone, g. 

cone, KD 

cone g. 

cone, KD 

cone, g. 

0* 

0 

7 

7 

14 

14 

21 

21 

28 

0.14 

0.98 

0.43 

2.0 

0.19 

1.1 

0.25 

1.2 

0.26 

0.31 

0.88 

0.27 

1.1 

<0.12 

0.75 

0.14 

0.58 

0.20 

<0.12 

0.24 

0.34 

1.4 

0.14 

0.75 

0.16 

0.60 

0.17 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

0.21 

0.39 

0.38 

1.6 

0.26 

1.30 

0.30 

1.2 

0.46 

0.90 

2.61 

1.54 

6.22 

0.83 

4.02 

0.97 

3.70 

1.21 

hop 

2 appl. 

OD 100 

Obernai 

N-France, 

2004 

cone, g. 

cone g. 

cone, g. 

cone, KD 

cone, g. 

cone, KD 

cone g. 

cone, KD 

cone, g. 

0* 

0 

8 

8 

15 

15 

22 

22 

29 

0.14 

0.97 

0.70 

2.3 

0.63 

2.6 

0.53 

2.2 

0.53 

<0.12 

0.32 

<0.12 

0.28 

<0.12 

0.32 

<0.12 

0.25 

<0.12 

<0.12 

0.20 

0.22 

0.62 

0.19 

0.72 

0.13 

0.45 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

0.10 

0.10 

0.15 

0.36 

0.14 

0.58 

0.15 

0.49 

0.15 

0.60 

1.71 

1.31 

3.68 

1.20 

4.34 

1.05 

3.51 

1.04 

hop 

1 appl. 

OD 150 

Gebrotshausen 

Germany, 

2005 

cone, g. 

cone, g. 

cone, g. 

cone, KD 

cone, g. 

cone, KD 

0 

7 

14 

14 

21 

21 

0.85 

0.28 

0.15 

1.5 

0.11 

0.93 

0.24 

0.12 

<0.12 

0.19 

<0.12 

0.21 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.08 

0.08 

0.08 

0.08 

0.08 

0.08 

1.41 

0.72 

0.59 

2.01 

0.55 

1.46 

hop 

1 appl. 

OD 150 

Schleithal 

N-France, 

2005 

cone, g. 

cone, g. 

cone, g. 

cone, KD 

cone, g. 

cone, KD 

0 

7 

13 

13 

20 

20 

0.94 

0.28 

0.15 

0.83 

0.10 

0.60 

0.30 

0.12 

0.12 

0.23 

0.12 

0.14 

<0.12 

<0.12 

<0.12 

0.43 

<0.12 

0.21 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.08 

0.08 

0.08 

0.13 

0.08 

0.13 

1.56 

0.72 

0.59 

1.74 

0.54 

1.20 

hop 

1 appl. 

OD 150 

Tettnang 

Germany, 

2005 

cone, g. 

cone, g. 

cone, KD 

cone, g. 

cone, KD 

0 

14 

14 

21 

21 

0.98 

0.32 

1.5 

0.21 

1.1 

0.36 

0.12 

0.32 

0.12 

0.31 

<0.12 

0.17 

0.88 

0.12 

0.52 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.08 

0.08 

0.29 

0.08 

0.33 

1.66 

0.81 

3.11 

0.65 

2.38 

hop 

1 appl. 

OD 150 

Obernai 

N-France, 

2005 

cone, g. 

cone, g. 

cone, KD 

cone, g. 

cone, KD 

0 

14 

14 

21 

21 

0.42 

<0.1 

0.61 

<0.1 

0.47 

0.12 

<0.12 

0.12 

<0.12 

0.12 

<0.12 

<0.12 

0.18 

<0.12 

0.13 

<0.12 

<0.12 

<0.12 

<0.12 

<0.12 

<0.08 

<0.08 

0.08 

<0.08 

0.08 

0.86 

0.54 

1.11 

0.54 

0.92 

* Before the last treatment 

** Residues of each analyte calculated as spirotetramat (BYI 08330) 

cone, g. cone, green 

cone, KD cone, kiln-dried 

The total residue in kiln-dried cones is composed of BYI08330, the enol, ketohydroxy and enol-glucoside 

metabolite. BYI08330-monohydroxy was not found. 

For the calculation of the MRL proposal, both of the prescribed methods I and II have been used for 

spirotetramat in hops (based on data obtained from glasshouse trials from northern Europe): 

MRL-calculation based on data obtained from the Northern Region:

Individual data points for hops are: 

1.11, 1.64, 1.74, 2.01, 2.62, 3.11, 4.02, 4.34 mg/kg 

Mean residue: 2.574 mg/kg; standard deviation: 1.167 mg/kg 

STMR: 2.315 mg/kg 
- 132 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Highest residue: 4.34 mg/kg 

Method I: Rmax = 6.293 mg/kg 

Method II: Rber = 7.585 mg/kg 

Based on the data available for hops from northern Europe, a MRL of 10 mg/kg can be proposed. 

Conclusion:

In 2004, 4 supervised residue trials in Northern Europe were carried out. These trials were conducted with to 

applications and a 17 % higher application rate with an interval between the applications of 14 days. Hence 

there was no significant difference between the results on green cones before and 14 days after the 2nd

application, the results from these trials were considered for MRL calculation. The residue trials conducted in 

2005 were in accordance to the intended GAP. Based on the submitted supervised residue trials a MRL of 

10 mg/kg can be proposed. 

Comments (RMS):

No comments. 

B.7.6.11 Overall conclusion 

Residue data from field trials on uses of spirotetramat in citrus, lettuce, fruiting vegetables, brassica 

vegetables and hops conducted in various locations all over Europe are reported and evaluated in order to 

accelerate the fixing of MRLs with respect to Regulation 396/2005/EU. 

Spirotetramat is applied as a spray solution to the different crops. Different formulations of spirotetramat 

were used: In 2004, residue trials were conducted with the OD 100 formulation of BYI08330. Due to a minor 

change of the final formulation from OD 100 to OD 150, residue trials in 2005 were conducted with the OD 

150 formulation of BYI08330. The composition of both formulations is similar; but the amount of the active 

substance is 100 g as/L in the OD 100 formulation and 150 g as/L in the OD 150 formulation. Applied at

identical use rates for the active substance, both formulations are considered to be comparable with respect 

to residues. 

Results from additional residue trials in lettuce and pepper are reported, which were conducted using the SC 

240 formulation of BYI08330 with the addition of 0.2 % RME (rape methyl ester) to the spray solution. 

Moreover, 2 trials in pepper were conducted with the SC 048 formulation of BYI08330. The results of these 

trials are reported to give a complete picture of the BYI08330 residue behaviour. 

Analysis of residue samples was conducted according to method 0087. The single analytes (spirotetramat

and its metabolites BYI08330-enol, -ketohydroxy, -monohydroxy and -enol-glucoside) are determined by 

HPLC-MS/MS. The results are expressed as parent equivalents. The total residue of spirotetramat is 

calculated by summing up the values determined for the individual analytes expressed as parent equivalent. 

Expressed as parent equivalents the LOQ is 0.01 mg/kg for spirotetramat, 0.012 mg/kg for BYI08330-enol, -

ketohydroxy and –monohydroxy and 0.08 mg/kg for BYI08330-enol-glucoside. For hop cones the respective 

LOQs are by a factor of 10 higher. The LOQ for the calculated total residue of BYI08330 is quoted at 0.054 

mg/kg (hops 0.54 mg/kg). 

For each trial residues at the envisaged PHI of the critical GAP were evaluated. If, however, the total residue 

of spirotetramat at later intervals exceeded the total residue at the PHI, the higher values were evaluated to 

cover the worst case residue. 

The residue data of each trial used for the evaluation are reported in the tables of Annex I at the end of the 

residue section. 
- 133 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.6.12 Stability of residues prior to analysis 

B.7.6.12.1 Storage stability in plant commodities 

Reference: Storage Stability of BYI 08330 and its Metabolites BYI08330-enol, BYI08330-

ketohydroxy, BYI08330-mono-hydroxy and BYI08330-enol-glucoside in/on 

Tomato (Fruit), Tomato (Paste), Potato (Tuber), Lettuce (Head), Climbing 

French Bean (Bean With Pod), and Almond (Nutmeat) for 24 Months. 

Author(s), year: Schöning, R., Wolters, A. (2007) 

Report/Doc. number: Report No.: MR-07/268, 

Edition Number: M-289421-01-2 

Guideline(s): PMRA Directive 98-02; DACO 7.3/EPA OPPTS 860.1380 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Reference: Storage Stability of BYI 08330 and its Metabolites BYI08330-enol, BYI08330-

ketohydroxy, BYI08330-mono-hydroxy and BYI08330-enol-glucoside in/on 

Orange (juice) and Prunes (Fruit) for 5 Months. 

Author(s), year: Schöning, R., Wolters, A. (2006) 

Report/Doc. number: Report No.: MR-06/076, 

Edition Number: M-276529-02-1 

Guideline(s): PMRA Directive 98-02; DACO 7.3/EPA OPPTS 860.1380 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Material and methods:

Samples of tomato (fruit and paste), potato (tuber), lettuce (head), climbing French bean (bean with pod) and 

almond (nutmeat) were spiked separately with 0.2 ppm of each spirotetramat (BYI 08330), BYI 08330-enol, 

BYI 08330-ketohydroxy, BYI 08330-mono-hydroxy, BYI 08330-enol-glucoside and stored at -18oC for 

approximately 30, 60, 90, 180, 370, 540, and 718 days. Samples spiked with BYI08330-enol were also 

analyzed for all analytes, with the exception of spirotetramat, and the total residues were expressed as 

BYI08330-enol equivalents. Samples that were spiked with BYI08330-ketohydroxy or BYI08330-monohydroxy or BYI08330-enol-Glc were analyzed and reported individually. Samples were analyzed by highperformance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) method 00857 using 

internal standards. Adequate method validation data were provided. 

 

A second study was performed to examine the effects of frozen storage on spirotetramat residues in orange 

juice and prunes. Samples of orange juice and prune fruit were spiked individually with 0.20 ppm of each 

spirotetramat, BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-monohydroxy, BYI 08330-enol-Glc and 

stored at <-18oC. Spiked samples were analyzed using method 00857 (LC-MS/MS method) at 0-, 30-, 90-, 

and 144/147-day intervals. 

Findings: 

A summary of the % corrected recoveries and % decline expressed as spirotetramat equivalents can be 

found in table B.7.6.12.1-1. 
- 134 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.6.12.1-1: Summary of Concurrent Recoveries of Spirotetramat and Metabolites from Plant Matrices. 

Spirotetramat BYI 08330-Enol BYI 08330- Ketohydroxy BYI 8330- Monohydroxy BYI 08330-Enol-Glc 

Matrix 

Spike 

level 

(mg/kg) 

Storage 

Interval 

(days) 

Sample 

size 

 (n) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) 

0.01 0 2 99, 100 100 105, 109 107 90, 105 98 94, 103 99 91, 101 96 0.2 32 2 91, 77 84 88, 72 86 95, 80 88 89, 73 81 91, 75 83 0.2 62 2 99, 94 97 97, 91 94 96, 92 94 103, 101 102 98, 93 96 0.2 91 2 73, 98 86 72, 103 87 74, 101 88 74, 97 85 70, 95 83 0.01 2 92, 90 91 95, 97 96 104, 107 106 100, 95 98 108, 103 106 0.2 

180 

2 73, 77 75 80, 85 83 87, 94 91 77, 86 82 77, 84 81

0.01 2 103, 72 88 103, 78 91 98, 74 86 108, 80 94 109, 80 95 0.2 

370 

2 85, 104 95 86, 101 94 86, 96 91 86, 98 92 84, 102 93 

0.01 2 93, 90 92 91, 86 89 102, 95 99 93, 88 91 93, 85 89 0.2 

543 

2 90, 90 90 89, 90 90 95, 94 95 87, 89 88 89, 91 90

0.01 2 106, 94 100 103, 105 104 96, 96 96 98, 101 100 103, 105 104 

Tomato (fruit) 

0.2 

718 

2 97, 86 92 97, 87 92 83, 93 88 96, 84 90 97, 87 92

0.01 0 2 73, 85 79 76, 96 86 86, 84 85 76, 89 83 70, 80 75 0.2 31 2 98, 96 97 93, 93 93 104, 103 104 97, 94 96 104, 96 100 0.2 62 2 75, 94 85 74, 88 81 78, 93 86 83, 95 89 69, 83 76 0.2 90 2 61, 85 73 64, 84 74 64, 90 77 66, 88 77 65, 90 78 0.01 2 89, 71 80 96, 82 89 112, 79 96 100, 88 94 107, 84 96 0.2 

180 

2 86, 79 83 103, 93 98 107, 91 99 106, 95 101 102, 90 96 

0.01 2 120, 97 109 98, 86 92 92, 82 87 105, 93 99 101, 86 94 0.2 

370 

2 82, 98 90 79, 104 92 81, 99 90 84, 103 94 74, 96 85 

0.01 2 65, 102 84 70, 87 79 65, 95 80 64, 100 82 62, 96 79 0.2 

543 

2 101, 101 101 100, 99 100 99, 100 100 101, 101 101 97, 100 99 

0.01 2 105, 100 103 105, 100 103 107, 100 104 97, 100 99 105, 100 103 

Potato (tuber) 

0.2 

717 

2 96, 82 89 93, 79 86 95, 81 88 95, 75 85 93, 79 86

0.01 0 2 94, 88 91 98, 93 96 90, 91 91 96, 89 92 99, 92 96 0.2 29 2 103, 99 101 96, 92 94 107, 102 105 96, 94 95 103, 93 98 0.2 62 2 96, 85 91 93, 85 89 93, 89 91 95, 86 90 91, 83 87 0.2 90 2 102, 103 103 104, 99 101 100, 98 99 99, 98 98 104, 109 107 0.01 2 96, 81 89 101, 84 93 98, 77 88 102, 84 93 100, 83 92 

Lettuce (head) 

0.2 

177 

2 92, 80 86 100, 87 94 102, 85 99 100, 89 94 97, 84 91 
- 135 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Spirotetramat BYI 08330-Enol BYI 08330- Ketohydroxy BYI 8330- Monohydroxy BYI 08330-Enol-Glc 

Matrix 

Spike 

level 

(mg/kg) 

Storage 

Interval 

(days) 

Sample 

size 

 (n) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) 

0.01 2 90, 94 92 90, 91 91 86, 95 91 99, 100 100 91, 100 96 0.2 

366 

2 96, 86 91 90, 82 86 89, 79 84 95, 85 90 93, 79 86

0.01 541 2 95, 98 97 91, 97 94 97, 93 95 106, 114 110 94, 101 98 0.2 2 97, 99 98 94, 96 95 95, 97 96 102, 98 100 101, 100 101 0.01 2 92, 95 94 84, 88 88 89, 94 92 94, 93 94 88, 88 88 0.2 

713 

2 96, 104 100 94, 98 96 101, 107 104 98, 103 101 94, 98 96 

0.01 0 2 70, 92 81 83, 102 93 68, 82 75 75, 99 87 73, 101 87 0.2 28 2 93, 95 94 84, 85 85 101, 103 102 88, 88 88 88, 90 89 0.2 60 2 82, 79 81 79, 75 77 87, 84 86 91, 84 88 87, 79 83 0.2 91 2 98, 95 97 91, 89 90 98, 90 94 102, 92 97 102, 88 95 0.01 2 86, 95 91 101, 98 100 96, 96 96 97, 96 96 116, 120 118 0.2 

177 

2 67, 87 77 73, 102 88 72, 98 85 73, 101 87 73, 103 88 

0.01 2 89, 91 90 87, 92 90 91, 107 99 86, 89 88 86, 84 85 0.2 

367 

2 92, 73 83 92, 71 82 101, 78 90 89, 68 78 91, 71 81 

0.01 2 89, 92 91 84, 91 88 90, 97 94 99, 105 102 84, 88 86 0.2 

542 

2 94, 76 85 89, 72 81 89, 72 81 97, 78 88 95, 75 85

0.01 2 85, 100 93 75, 95 85 79, 102 91 80, 99 90 75, 95 80 

Climbing French Bean (bean with pod) 

0.2 

714 

2 88, 89 89 87, 83 85 90, 91 91 88, 87 88 87, 83 85

0.01 0 2 103, 104 104 106, 103 105 98, 101 100 99, 101 100 98, 89 94 0.2 26 2 101, 103 102 94, 95 95 109, 109 109 96, 98 97 102, 101 102 0.2 61 2 101, 101 101 100, 97 99 104, 105 105 103, 106 104 98, 95 97 0.2 90 2 95, 95 95 102, 100 101 97, 101 99 99, 100 100 99, 103 101 0.01 2 85, 90 88 85, 97 91 94, 93 94 94, 93 94 89, 96 93 0.2 

177 

2 91, 94 93 97, 94 96 103, 105 104 105, 100 102 102, 98 100 

0.01 2 89, 88 90 99, 95 97 100, 100 100 93, 99 96 101, 94 98 0.2 

367 

2 90, 81 86 98, 84 91 93, 85 89 94, 83 88 91, 84 88

0.01 2 89, 90 90 91, 97 94 100, 90 95 103, 108 106 94, 92 93 0.2 

541 

2 84, 92 88 93, 99 96 93, 99 96 91, 95 93 85, 90 88

0.01 2 84, 83 84 83, 85 84 82, 82 82 86, 84 85 87, 87 87 

Almond (nutmeat) 

0.2 

713 

2 84, 87 86 86, 88 87 87, 88 88 88, 89 89 86, 90 88

0.01 0 2 100, 99 100 75, 76 76 100, 98 99 102, 102 102 101, 101 101 Tomato 

(paste) 0.2 30 2 89, 84 87 89, 84 87 96, 90 93 95, 92 94 86, 85 86 
- 136 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Spirotetramat BYI 08330-Enol BYI 08330- Ketohydroxy BYI 8330- Monohydroxy BYI 08330-Enol-Glc 

Matrix 

Spike 

level 

(mg/kg) 

Storage 

Interval 

(days) 

Sample 

size 

 (n) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) Recovery (%) Average Recovery (%) 

0.2 61 2 96, 97 97 106, 111 109 103, 96 99 105, 108 107 102, 104 103 0.2 93 2 91, 101 96 101, 101 101 95, 103 99 99, 100 100 96, 96 96 0.01 2 101, 101 101 96, 98 97 92, 82 99 93, 101 97 96, 95 96 0.2 

187 

2 90, 103 97 94, 101 98 88, 97 93 90, 93 92 86, 92 89 

0.01 2 95, 99 97 103, 91 97 97, 94 96 92, 91 92 80, 81 81 0.2 

373 

2 96, 90 93 98, 95 97 94, 89 92 97, 91 94 96, 92 94

0.01 2 90, 81 86 84, 76 80 97, 82 90 89, 81 85 82, 85 84 0.2 

542 

2 92, 94 93 87, 87 87 95, 96 96 89, 89 89 89, 90 90

0.01 715 2 93, 101 97 95, 99 97 99, 95 97 98, 92 95 87, 91 89 0.2 2 96, 98 97 100, 101 101 95, 97 96 90, 95 93 86, 90 88 0.01 3 104, 97, 

98 

100 102, 100, 

101 

101 89, 91, 97 92 93, 90, 89 91 93, 90, 89 91 

0.2 

0 

3 104, 90, 

102 

99 101, 88, 

100 

96 87, 91, 94 91 88, 89, 91 89 88, 89, 91 89 

0.2 30 2 74, 91 83 76, 94 85 72, 90 81 68, 87 78 68, 87 78 0.2 92 2 99, 96 98 108, 103 105 108, 103 106 102, 98 100 102, 98 100 

Orange (juice) 

0.2 144 2 93, 86 89 100, 91 95 117, 98 108 87, 86 86 87, 86 87 

0.01 3 101, 101, 

97 

100 101, 98, 

95 

98 82, 86, 87 85 90, 87, 83 87 90, 87, 83 87 

0.2 

0 

3 96, 96, 

100 

97 96, 94, 

100 

97 86, 84, 83 84 85, 87, 86 86 85, 87, 86 86 

0.2 30 2 90, 95 93 91, 94 93 92, 91 92 90, 98 94 90, 98 94 0.2 92 2 101, 101 101 99, 97 98 83, 88 86 94, 94 94 94, 94 94 

Prunes (fruit) 

0.2 147 2 94, 95 94 105, 100 102 103, 98 101 103, 93 98 103, 93 98 
- 137 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Samples spiked with spirotetramat were analyzed for all analytes and the total residues were expressed as 

BYI08330 equivalents.Total spirotetramat residues were stable (<30% degradation) in all matrices during 

freezer storage for up to 718 days. Total BYI08330-enol residues declined by 35% in tomato paste after 715 

days of freezer storage. Residues of BYI 08330-ketohydroxy, -mono-hydroxy and -enol-Glc were stable 

(<30% degradation) in all matrices analyzed for up to 718 days (see Table B.7.6.12.1-2). 

Table B.7.6.12.1-2: Summary of the Stability of Total Residues of Spirotetramat (BYI 08330) in Plant 

Matrices Following Storage at -18°C. 

Total 

Spirotetra

mat 

Residues 

Commodity Spiking level 

(mg/kg) 

Storage interval 

(days) n 

mg/kg 

% uncorrected 

recovery 

% 

corrected 

recovery* 

% decline 

0 5 0.189 95 95 5 

32 3 0.202 101 121 -- 

62 3 0.171 86 89 11 

91 3 0.184 92 107 -- 

180 3 0.173 87 115 -- 

370 3 0.177 89 93 7 

543 3 0.187 94 104 -- 

Tomato Fruit 0.2 

718 3 0.185 93 101 -- 

0 5 0.178 89 112 -- 

31 3 0.196 98 101 -- 

62 3 0.168 84 99 1 

90 3 0.150 76 103 -- 

180 3 0.196 98 118 -- 

370 3 0.183 92 102 -- 

543 3 0.137 69 68 32 

Potato Tuber 0.2 

717 3 0.171 86 96 4 

0 5 0.167 84 92 8 

29 3 0.193 97 96 4 

62 3 0.197 99 108 -- 

90 3 0.183 92 89 11 

177 3 0.183 92 106 -- 

366 3 0.192 96 105 -- 

541 3 0.190 95 97 3 

Head lettuce 0.2 

713 3 0.185 93 93 7 

0 5 0.179 90 110 -- 

28 3 0.176 88 94 6 

60 3 0.173 87 107 -- 

91 3 0.180 90 93 7 

177 3 0.189 95 123 -- 

367 3 0.211 106 127 -- 

542 3 0.164 82 96 4 

Climbing 

French bean 

0.2 

714 3 0.170 85 98 2 

0 5 0.169 85 85 15 

26 3 0.217 109 109 -- 

61 3 0.202 101 101 -- 

90 3 0.190 95 100 -- 

177 3 0.187 94 101 -- 

367 3 0.176 88 102 -- 

541 3 0.179 90 102 -- 

Almond 

nutmeat 

0.2 

713 3 0.168 84 98 2 
- 138 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Total 

Spirotetra

mat 

Residues 

Commodity Spiking level 

(mg/kg) 

Storage interval 

(days) n 

mg/kg 

% uncorrected 

recovery 

% 

corrected 

recovery* 

% decline 

0 5 0.208 104 104 -- 

30 3 0.200 100 115 -- 

61 3 0.200 100 103 -- 

93 3 0.198 99 103 -- 

187 3 0.165 83 85 15 

373 3 0.175 88 94 6 

542 3 0.191 96 103 -- 

Tomato Paste 0.2 

715 3 0.183 92 94 6 

0 5 0.197 99 99 1 

30 3 0.147 74 89 11 

92 3 0.179 89 91 9 

Orange juice 0.2 

144 3 0.191 96 107 -- 

0 5 0.193 97 99 1 

30 3 0.139 70 75 25 

92 3 0.171 86 86 14 

Prunes 0.2 

147 3 0.166 83 88 12 

* Corrected for mean concurrent recovery (see Table B.7.6.12.1-1). 

Total residues of spirotetramat in orange juice and prunes were stable (<30% degradation) during frozen 

storage for up to 147 days. 

Conclusion:

There are adequate storage stability data to validate the storage conditions and intervals of samples 

collected from the field trial studies. 

B.7.7 Effects of industrial processing and/or household preparation (Annex IIA 6.5; Annex 

IIIA 8.5) 

B.7.7.1 Effects on the nature of the residue 

B.7.7.1.1 BYI 08330 

Reference: BYI 08330: Aqueous hydrolysis under conditions of processing studies 

Author(s), year: Koch, Sur; 2005, amended April 2006 

Report/Doc. number: MEF-04/562 

M-269158-02-1 

Guideline(s): EU Council Directive 91/414/EEC as amended by Commission Directive 96/68/EC 

Section 6.5, Subsection 6.5.1. Guideline 7035/VI/95 Revision 5, Appendix E (July 

1997) 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of this study was to describe the degradation behaviour of the insecticide spirotetramat (BYI 

08330) in buffered drinking water. The experiments were carried out under laboratory conditions which are 

representative for processing operations of raw agricultural commodities. 
- 139 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Material and methods:

The experiments were performed with two different concentrations. [Azaspirodecenyl-3-14C]FHN 12952 (BYI 

08330) was applied at two different projected doses of 0.2 mg a.s./L (experiment 1) and of 1.0 mg a.s./L 

(experiment 2) buffer solution. To simulate the conditions of processing studies, non-sterilized drinking water 

was used. The test systems were incubated at three representative sets of hydrolysis conditions: 

Pasteurisation: 90 °C at pH 4 for 20 min (water bath); 

Baking, brewing, boiling: 100 °C at pH 5 for 60 min (water bath); and 

Sterilisation: 120 °C at pH 6 for 20 min (autoclave). 

The pH was adjusted to and remained at pH 4, pH 5 and pH 6 (each ± 0.2) as required. The temperatures 

were in the required ranges of 90 ± 3 °C (89.9-90.2°C), 100 ± 3 °C (97.8 to 99.8) and 120 ± 3 °C during the 

test periods. The periods for heating and cooling to the required temperatures prior to and after the 

incubation, respectively, were not regarded as test periods. The test period started, when the required 

temperature was reached and was terminated by cooling down, when the test time was over. 

At time zero (test start) and at test termination, the content of radioactivity was determined in the samples by 

liquid scintillation counting. Parent compound and hydrolysis product were identified and quantified by HPLC. 

For the HPLC method, the detection limit of components in the test solutions was determined. The LOD is 

defined as a signal which is 2.5 to 3 times the Signal/Noise ratio. The detection limit meets the requirement 

of the guideline, where identification is asked for hydrolysis products in concentrations higher or equal to 

0.05 mg/kg. The calculated recovery was 99.9%. Since no radioactivity remained on the column, the HPLCmethod was proven to be valid for the analysis of the samples. 

Thin layer chromatography (TLC) was used as second method for identification of active substance and 

hydrolysis product by co-chromatography with non labelled reference items. 

Findings:

The applied radioactivity was defined as the amount of radioactivity measured in the subsamples taken at 

the beginning of the incubation period. Based on the results of LSC measurements immediately after test 

termination, a radioactivity balance was established for each experiment. The material balances ranged from 

100.0% to 111.4% of the applied radioactivity for experiment 1 and from 102.5% to 107% for experiment 2. 

The material balances demonstrate that no radioactivity and no volatile decomposition product dissipated 

from the test system. The concentration effect is due to increasing evaporation of water from the test system 

with increasing temperature. 

Quantitative analysis and identification of the active substance and the hydrolysis product by cochromatography was performed by HPLC for all samples. 

At zero-time, the active substance BYI 08330 was stable and amounted to between 99.5% and 100% of the 

applied radioactivity (AR) for both experiments. During the treatment the active substance degraded to BYI 

08330-enol (reference item code: A1302944) in different amounts, depending on the pH value. At pH 4 / 

90°C the active substance is stable (experiment 1: 98.0% of the AR; experiment 2: 98.1% of the AR). At

pH=5 / 100°C a degradation of ca. 15% is found (experiment 1: BYI 08330 is 84.5% of the AR; experiment 2: 

BYI 08330 is 86.0% of the AR). At pH=6 / 120°C the degradation was nearly complete. The active substance 

decreased to 14.6% of the AR (experiment 1) and 16.3% of the AR (experiment 2). Identification of the active 

substance and of BYI 08330-enol was performed by HPLC co-chromatography with the non-labelled 

reference item for all samples. No further hydrolysis products or degradation products were found. 

The quantification of BYI 08330 and BYI 08330-enol in the test solutions is presented in Table B.7.7.1.1-1: 
- 140 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.1.1-1: Quantification of BYI 08330 and BYI 08330-enol in the samples of experiment 1 and 

experiment 2 by HPLC [expressed as percentage of applied radioactivity: 

Experiment 1 

(0.2 mg a.s./L) 

Experiment 2 

(1 mg a.s./L) 

compound BYI 08330 BYI 08330-enol BYI 08330 BYI 08330-enol 

time pH 

/ temp. 

Area% 

1)

Mean% 

2)

Area% 

1)

Mean% 

2)

Area% 

1)

Mean% 

2)

Area% 

1)

Mean% 

2)

pH=4 

90 °C 

100.0 

99.5 

99.7 0.0 

0.5 

0.3 100.0 

100.0 

100.0 0.0 

0.0 

0.0 

pH=5 

100 °C 

99.5 

99.5 

99.5 0.5 

0.5 

0.5 100.0 

100.0 

100.0 0.0 

0.0 

0.0 

Zero time 

pH=6 

120 °C 

99.0 

100.0 

99.5 1.0 

0.0 

0.5 100.0 

99.5 

99.7 0.0 

0.5 

0.3 

pH=4 

90 °C 

98.1 

97.8 

98.0 1.9 

2.2 

2.0 98.4 

97.8 

98.1 1.6 

2.2 

1.9 

pH=5 

100 °C 

84.7 

84.3 

84.5 15.3 

15.7 

15.5 86.3 

85.8 

86.0 13.7 

14.3 

14.0 

Test 

termination 

pH=6 

120 °C 

14.6 

14.6 

14.6 85.4 

85.4 

85.4 16.2 

16.5 

16.3 83.8 

83.5 

83.7 

1) Area% of HPLC analysis

2) Area% mean value of two samples 

TLC was used as second analytical method for identification of the active substance and of the degradation 

product BYI 08330-enol by co-chromatography. No further hydrolysis products or degradation products were 

found. 

Conclusion:

BYI 08330 (spirotetramat) is hydrolysed under conditions being representative for processing studies. At 

conditions of pH=4 / 90°C (20 min) representing pasteurisation, no significant hydrolysis was found. At 

pH=5 / 100 °C (60 min) ca. 15% degradation was observed. At conditions of pH=6 / 120 °C (20 min) 

representing sterilisation, the active substance degraded nearly completely (ca. 85%). BYI 08330-enol

was found as the only hydrolysis product formed. 

B.7.7.1.2 BYI 08330-enol 

Reference: BYI 08330-enol: Aqueous hydrolysis under conditions of processing studies 

Author(s), year: Koch, Sur; 2006 

Report/Doc. number: MEF-05/227 

M-267011-01-1 

Guideline(s): EU Council Directive 91/414/EEC as amended by Commission Directive 96/68/EC 

Section 6.5, Subsection 6.5.1. Guideline 7035/VI/95 Revision 5, Appendix E (July 

1997) 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of this study was to describe the degradation behaviour of the BYI 08330-enol in buffered 

drinking water. The experiments were carried out under laboratory conditions which are representative for 

processing operations of raw agricultural commodities. 

Material and methods:

The experiments were performed with two different concentrations. [Azaspirodecenyl-3-14C]cis-BYI 08330-

enol was applied at two different projected doses of 0.2 mg a.s./L (experiment 1) and of 1.0 mg a.s./L
- 141 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

(experiment 2) buffer solution. To simulate the conditions of processing studies, non-sterilized drinking water 

was used. The test systems were incubated at three representative sets of hydrolysis conditions: 

Pasteurisation: 90 °C at pH 4 for 20 min (water bath); 

Baking, brewing, boiling: 100 °C at pH 5 for 60 min (water bath); and 

Sterilisation: 120 °C at pH 6 for 20 min (autoclave). 

The pH was adjusted to and remained at pH 4, pH 5 and pH 6 (each ± 0.2) as required. The temperatures 

were in the required ranges of 90 ± 3 °C (90.1°C), 100 ± 3 °C (100.1) and 120 ± 3 °C during the test periods. 

The periods for heating and cooling to the required temperatures prior to and after the incubation, 

respectively, were not regarded as test periods. The test period started, when the required temperature was 

reached and was terminated by cooling down, when the test time was over. 

At time zero (test start) and at test termination, the content of radioactivity was determined in the samples by 

liquid scintillation counting. Parent compound and hydrolysis product were identified and quantified by HPLC. 

By the time of the beginning of the present study several analytical works on metabolism of BYI 08330 has 

already been reported; in these studies the recovery of a.i. and metabolites in several HPLC systems is

described. During the work on these studies no evidence had been observed that the test item or one of the 

hydrolysis products are not completely recovered after chromatography. Therefore, no further work was done 

to reinvestigate the recovery of this HPLC method. For the HPLC system, the detection limit (LOD) is 

expressed as minimum area required for a peak, The LOD expressed as % of the injected RA (radioactivity) 

was calculated. For experiment A the LOD was in the range from 0.9% to 1.2%, for experiment B the 

LOD was ≤1% for all chromatograms. 

Findings:

The applied radioactivity was defined as the amount of radioactivity measured in the subsamples taken at 

the beginning of the incubation period. Based on the results of LSC measurements immediately after test 

termination, a radioactivity balance was established for each experiment. The material balances ranged from 

103.0% to 104.8% of the applied radioactivity for experiment 1 and from 103.6% to 112.2% for experiment 2. 

The material balances demonstrate that no radioactivity and no volatile decomposition product dissipated 

from the test system. The concentration effect is due to increasing evaporation of water from the test system 

with increasing temperature. 

Quantitative analysis and identification by co-chromatography was performed by HPLC for all samples. 

BYI 08330-enol remained unaffected under all tested conditions. In none of the samples hydrolysis 

products were found. 

The measured radioactivity in test solutions is presented in Table B.7.7.1.2-1: 

Table B.7.7.1.2-1: Measured radioactivity in test solutions: 

Experiment 1 

(0.2 mg a.s./L) 

Experiment 2 

(1 mg a.s./L) 

compound BYI 08330-enol BYI 08330-enol 

time pH 

/ temp. 

Total 

[Bq] 

Mean 

Total 

[Bq] 

samples 

Test item 

equivalents

[μg/L] 1)

Total 

[Bq] 

Mean 

Total 

[Bq] 

samples 

Test item 

equivalents

[μg/L] 1)

pH=4 

90 °C 

5271.5 

5256.0 

5264 231.9 23950.0 

21339.0 

22645 997.6 

pH=5 

100 °C 

4975.0 

5245.0 

5110 225.1 22870.0 

24094.0 

23482 1034.4 

Zero time 

pH=6 

120 °C 

5151.5 

5203.0 

5177 228.1 21932.5 

24196.5 

23065 1016.1 

Test 

termination 

pH=4 

90 °C 

5328.0 

5512.5 

5420 238.8 22334.0 

24574.0 

23454 1033.2 
- 142 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Experiment 1 

(0.2 mg a.s./L) 

Experiment 2 

(1 mg a.s./L) 

compound BYI 08330-enol BYI 08330-enol 

time pH 

/ temp. 

Total 

[Bq] 

Mean 

Total 

[Bq] 

samples 

Test item 

equivalents

[μg/L] 1)

Total 

[Bq] 

Mean 

Total 

[Bq] 

samples 

Test item 

equivalents

[μg/L] 1)

pH=5 

100 °C 

5281.0 

5244.0 

5263 231.8 24311.0 

25183.5 

24747 1090.2 

pH=6 

120 °C 

5412.5 

5440.0 

5426 239.0 25786.0 

25964.5 

25875 1139.9 

1) Calculation: [Mean Total (Bq) / specific activity: 4540 Bq/μg] / (processing volume: 0.005 L)

Conclusion:

BYI 08330-enol was found to be resistant to hydrolysis under conditions being representative for 

processing studies. At conditions of pH=4 / 90°C (20 min) as well as at conditions of pH=5 / 100 °C (60 min) 

and at conditions of pH=6 / 120 °C (20 min) BYI 08330-enol remained unchanged. This result is in 

accordance to the finding in the processing study of BYI 08330 (parent spirotetramat): under conditions of 

processing studies BYI 08330 was hydrolyzed to BYI 08330-enol, but no further degradation products were 

formed (see B.7.7.1.1). 

Therefore, hydrolysis does not affect the nature of BYI 08330-enol residues during raw agricultural 

commodity processing operations. 

B.7.7.1.3 BYI 08330-enol-glucoside 

Reference: BYI 08330-enol-glucoside: Aqueous hydrolysis under conditions of 

processing studies 

Author(s), year: Koch, Sur; 2006 

Report/Doc. number: MEF-05/274 

M-266907-01-1 

Guideline(s): EU Council Directive 91/414/EEC as amended by Commission Directive 96/68/EC 

Section 6.5, Subsection 6.5.1. Guideline 7035/VI/95 Revision 5, Appendix E (July 

1997) 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of this study was to describe the degradation behaviour of the BYI 08330-enol-glucoside in

buffered drinking water. The experiments were carried out under laboratory conditions which are 

representative for processing operations of raw agricultural commodities. 

Material and methods:

The experiments were performed with two different concentrations. [Azaspirodecenyl-3-14C]-BYI 08330-enolglucoside was applied at two different projected doses of 0.2 mg a.s./L (experiment 1) and of 1.0 mg a.s./L 

(experiment 2) buffer solution. To simulate the conditions of processing studies, non-sterilized drinking water 

was used. The test systems were incubated at three representative sets of hydrolysis conditions: 

Pasteurisation: 90 °C at pH 4 for 20 min (water bath); 

Baking, brewing, boiling: 100 °C at pH 5 for 60 min (water bath); and 

Sterilisation: 120 °C at pH 6 for 20 min (autoclave). 
- 143 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The pH was adjusted to and remained at pH 4, pH 5 and pH 6 (each ± 0.2) as required. The temperatures 

were in the required ranges of 90 ± 3 °C (89.9 to 89.95°C), 100 ± 3 °C (99.85 to 100.0 °C) and 120 ± 3 °C 

during the test periods. The periods for heating and cooling to the required temperatures prior to and after 

the incubation, respectively, were not regarded as test periods. The test period started, when the required 

temperature was reached and was terminated by cooling down, when the test time was over. 

At time zero (test start) and at test termination, the content of radioactivity was determined in the samples by 

liquid scintillation counting. Parent compound and hydrolysis product were identified and quantified by HPLC. 

By the time of the beginning of the present study several analytical works on metabolism of BYI 08330 has 

already been reported; in these studies the recovery of a.i. and metabolites in several HPLC systems is

described. During the work on these studies no evidence had been observed that the test item or one of the 

hydrolysis products is not completely recovered after chromatography. Therefore, no further work was done 

to reinvestigate the recovery of this HPLC method. For the HPLC method, the detection limit of components 

in the test solutions was determined yet (see B.1.7.1.1). The LOD is defined as a signal which is 2.5 to 3 

times the signal/noise ratio. The LOD was <1% of the applied radioactivity for all chromatograms. The 

detection limit meets the requirement of the guideline, where identification is asked for hydrolysis products in 

concentrations higher or equal to 0.05 mg/kg. 

Findings:

The applied radioactivity was defined as the amount of radioactivity measured in the subsamples taken at 

the beginning of the incubation period. Based on the results of LSC measurements immediately after test 

termination, a radioactivity balance was established for each experiment. The material balances ranged from 

103.1% to 104.8% of the applied radioactivity for experiment 1 and from 100.3% to 103.3% for experiment 2. 

The material balances demonstrate that no radioactivity and no volatile degradation products dissipated from 

the test system. The concentration effect is due to the evaporation of water from the test system during 

processing. 

The test item was hydrolysed to BYI 08330-enol in different amounts, depending on the processing 

conditions. BYI 08330-enol-glucoside was demonstrated to be resistant to hydrolysis under conditions being 

representative for pasteurisation. Under conditions representative for baking, brewing and boiling a 

degradation of ca. 10% was found. Under conditions of sterilisation ca. 40% of the test item were hydrolysed. 

BYI 08330-enol was found as the only hydrolysis product. 

The quantification of BYI 08330-enol-glucoside and BYI 08330-enol in the test solutions is presented in 

Table B.7.7.1.3-1. 

Table B.7.7.1.3-1: Quantification of BYI 08330-enol-glucoside and BYI 08330-enol in the samples of 

experiment 1 and experiment 2 by HPLC [expressed as percentage of applied radioactivity]: 

Experiment 1 

(0.2 mg a.s./L) 

Experiment 2 

(1 mg a.s./L) 

compound BYI 08330-enolglucoside BYI 08330-enol BYI 08330-enolglucoside BYI 08330-enol 

time pH 

/ temp. 

Area% 

1)

Mean% 

2)

Area% 

1)

Mean% 

2)

Area% 

1)

Mean% 

2)

Area% 

1)

Mean% 

2)

pH=4 

90 °C 

100.0 

100.0 

100.0 0.0 

0.0 

0.0 100.0 

100.0 

100.0 0.0 

0.0 

0.0 

pH=5 

100 °C 

100.0 

100.0 

100.0 0.0 

0.0 

0.0 100.0 

100.0 

100.0 0.0 

0.0 

0.0 

Zero time 

pH=6 

120 °C 

100.0 

100.0 

100.0 0.0 

0.0 

0.0 100.0 

100.0 

100.0 0.0 

0.0 

0.0 

pH=4 

90 °C 

98.4 

98.2 

98.3 1.7 

1.8 

1.7 98.4 

98.6 

98.5 1.7 

1.5 

Test 1.6 

termination 

pH=5 

100 °C 

91.9 

92.2 

92.1 8.1 

7.8 

7.9 89.3 

89.9 

89.9 10.7 

10.1 

10.4 
- 144 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Experiment 1 

(0.2 mg a.s./L) 

Experiment 2 

(1 mg a.s./L) 

compound BYI 08330-enolglucoside BYI 08330-enol BYI 08330-enolglucoside BYI 08330-enol 

time pH 

/ temp. 

Area% 

1)

Mean% 

2)

Area% 

1)

Mean% 

2)

Area% 

1)

Mean% 

2)

Area% 

1)

Mean% 

2)

pH=6 

120 °C 

58.7 

58.0 

58.3 41.3 

42.0 

41.7 58.6 

58.2 

58.4 41.4 

41.8 

41.6 

1) Calculation: [Mean Total (Bq) / specific activity: 2990 Bq/μg] / (processing volume: 0.005 L)

2) Calculation: [Mean Total (Bq) / specific activity: 639 Bq/μg] / (processing volume: 0.005 L)

Conclusion:

BYI 08330-enol-glucoside was found to be hydrolysed under certain conditions being representative for 

processing studies. At conditions of pH=4 / 90 °C (20 min) no significant hydrolysis was found. At pH=5 / 100 

°C (60 min) ca. 10% degradation was observed. At conditions of pH=6 / 120 °C (20 min) ca. 40% 

degradation was found. BYI 08330-enol was the only hydrolysis product formed. 

B.7.7.1.4 BYI 08330-keto-hydroxy 

Reference: BYI 08330-keto-hydroxy: Aqueous hydrolysis under conditions of 

processing studies 

Author(s), year: Koch, Sur; 2006 

Report/Doc. number: MEF-05/409 

M-267024-01-1 

Guideline(s): EU Council Directive 91/414/EEC as amended by Commission Directive 96/68/EC 

Section 6.5, Subsection 6.5.1. Guideline 7035/VI/95 Revision 5, Appendix E (July 

1997) 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of this study was to describe the degradation behaviour of the BYI 08330-keto-hydroxy in 

buffered drinking water. The experiments were carried out under laboratory conditions which are 

representative for processing operations of raw agricultural commodities. 

Material and methods:

The experiments were performed with two different concentrations. [Azaspirodecenyl-3-14C]FHN-14066 (BYI 

08330-keto-hydroxy) was applied at two different projected doses of 0.2 mg a.s./L (experiment 1) and of 1.0 

mg a.s./L (experiment 2) buffer solution. To simulate the conditions of processing studies, non-sterilized 

drinking water was used. The test systems were incubated at three representative sets of hydrolysis 

conditions: 

Pasteurisation: 90 °C at pH 4 for 20 min (water bath); 

Baking, brewing, boiling: 100 °C at pH 5 for 60 min (water bath); and 

Sterilisation: 120 °C at pH 6 for 20 min (autoclave). 

The pH was adjusted to and remained at pH 4, pH 5 and pH 6 (each ± 0.2) as required. The temperatures 

were in the required ranges of 90 ± 3 °C (89.9 to 90.3°C), 100 ± 3 °C (100.0 to 100.8 °C) and 120 ± 3 °C 

(120 to 121.4 °C) during the test periods. The periods for heating and cooling to the required temperatures 

prior to and after the incubation, respectively, were not regarded as test periods. The test period started, 
- 145 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

when the required temperature was reached and was terminated by cooling down, when the test time was 

over. 

The 14C-radioactivity of liquid samples was determined by liquid scintillation counting (LSC). Parent 

compound and hydrolysis product were identified and quantified by HPLC. By the time of the beginning of 

the present study analytical work on aqueous hydrolysis under conditions of processing studies of BYI 08330 

had already been finished (see B.7.7.1.1). In these studies the quantitative recovery of the active substance 

and metabolites is described using the similar HPLC method. Therefore no work was done to reinvestigate 

the recovery of this HPLC method. For the HPLC method a detection of 1% of the injected radioactivity is 

required: In the HPLC-chromatograms peaks of <1 area% were detectable. The detection limit meets the 

requirement of the guideline, where identification is asked for hydrolysis products in concentrations higher or 

equal to 0.05 mg/kg. 

Thin layer chromatography was used for identification of test item by co-chromatography with non labelled 

reference standards. 

During the treatment the test item hydrolysed to BYI 08330-MA-amide. The structure of the compound was

elucidated by NMR and MS techniques after isolation by HPLC. 

Findings:

The applied radioactivity was defined as the amount of radioactivity measured in the subsamples taken at 

the beginning of the incubation period. Based on the results of LSC measurements immediately after test 

termination, a radioactivity balance was established for each experiment. The material balances ranged from 

100.3% to 106.5% of the applied radioactivity for experiment 1 and from 101.1% to 102.2% for experiment 2. 

The material balances demonstrate that no radioactivity and no volatile degradation products dissipated from 

the test system. The concentration effect is due to the evaporation of water from the test system during 

processing. 

The measured radioactivity in test solutions is presented in Table B.7.7.1.4-1. 

Table B.7.7.1.4-1: Measured radioactivity in test solutions: 

Experiment 1 

(0.2 mg a.s./L) 

Experiment 2 

(1 mg a.s./L) 

compound BYI 08330- keto-hydroxy BYI 08330- keto-hydroxy 

time pH 

/ temp. 

Total 

[Bq] 

Mean 

Total 

[Bq] 

samples 

Test item 

equivalents

[μg/L] 1)

Total 

[Bq] 

Mean 

Total 

[Bq] 

samples 

Test item 

equivalents

[μg/L] 1)

pH=4 

90 °C 

4332.9 

4476.7 

4405 204.4 21705.00 

22388.33 

22047 1023.0 

pH=5 

100 °C 

4358.3 

4473.8 

4416 204.9 22098.33 

22406.67 

22253 1032.6 

Zero time 

pH=6 

120 °C 

4006.7 

4373.3 

4190 194.4 21865.00 

22028.33 

21947 1018.4 

pH=4 

90 °C 

4327.5 

4515.0 

4421 205.2 22075.00 

22505.00 

22290 1034.3 

pH=5 

100 °C 

4382.1 

4473.8 

4428 205.5 22385.00 

22680.00 

22533 1045.6 

Test 

termination 

pH=6 

120 °C 

4421.7 

4501.3 

4461 207.0 22410.00 

22443.33 

22427 1040.7 

1) Calculation: [Mean Total (Bq) / specific activity: 4310 Bq/μg] / (processing volume: 0.005 L)

At zero-time, the test item BYI 08330-keto-hydroxy was stable and amounted to between 99.5% and 99.8% 

of the applied radioactivity for experiment 1 and t between 99.4% and 99.6% of the applied radioactivity for 

experiment 2 (see Table B.7.7.1.4-2). During the treatment the test item hydrolysed to BYI 08330-MAamide. The amount of degradation depended on the pH value. At pH 4 / 90°C the test item was stable 

(experiment 1: 99.5% of the AR; experiment 2: 99.5% of the AR). At pH=5 / 100°C a degradation of ca. 5% is 

found (experiment 1: BYI 08330-keto-hydroxy is 95.4% of the AR; experiment 2: BYI 08330-keto-hydroxy is 
- 146 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

95.3% of the AR). At pH=6 / 120°C the degradation was nearly complete. The test item decreased to 0.9% of 

the AR (experiment 1) and 0.5% of the AR (experiment 2). 

A minor hydrolysis product was detected in both experiments at pH=6 / 120°C (retention time: 36.5 min). 

Because of the low amount (mean content <1% of AR) no characterisation work was spent on this 

compound. 

No further hydrolysis products or degradation products were found. 

Table B.7.7.1.4-2: Quantification of BYI 08330-keto-hydroxy and BYI 08330-MA-amide in the samples 

of experiment 1 (top) and experiment 2 (bottom) byHPLC 

BYI 08330- ketohydroxy 1) BYI 08330-MA-amide 1) Unknown 1)

Experiment 1 

(0.2 mg a.s./L) Area% 

2) Mean% 3) Area% 2) Mean% 3) Area% 2) Mean% 3)

pH=4 

90 °C 

99.5 

99.5 

99.5 0.5 

0.5 

0.5 --- 

--- 

--- 

pH=5 

100 °C 

99.6 

99.5 

99.6 0.4 

0.5 

0.4 --- 

--- 

--- 

Zero time 

pH=6 

120 °C 

99.6 

100.0 

99.8 0.4 

0.0 

0.2 --- 

--- 

--- 

pH=4 

90 °C 

99.5 

99.5 

99.5 0.5 

0.5 

0.5 --- 

--- 

--- 

pH=5 

100 °C 

95.4 

95.4 

95.4 4.6 

4.6 

4.6 --- 

--- 

--- 

Test 

termination 

pH=6 

120 °C 

1.3 

0.6 

0.9 98.3 

99.0 

98.6 0.4 

0.4 

0.4 

BYI 08330- ketohydroxy 1) BYI 08330-MA-amide 1) Unknown 1)

Experiment 2 

(1 mg a.s./L) Area% 

2) Mean% 3) Area% 2)

Area% 

2) Mean% 3) Area% 2)

pH=4 

90 °C 

99.6 

99.4 

99.5 0.4 

0.6 

0.5 --- 

--- 

--- 

pH=5 

100 °C 

99.4 

99.5 

99.4 0.6 

0.5 

0.6 --- 

--- 

--- 

Zero time 

pH=6 

120 °C 

99.6 

99.5 

99.6 0.4 

0.5 

0.4 --- 

--- 

--- 

pH=4 

90 °C 

99.5 

99.5 

99.5 0.5 

0.5 

0.5 --- 

--- 

--- 

pH=5 

100 °C 

95.5 

95.1 

95.3 4.6 

4.9 

4.7 --- 

--- 

--- 

Test 

termination 

pH=6 

120 °C 

0.5 

0.5 

0.5 98.9 

99.1 

99.0 0.6 

0.5 

0.5 

1) Amounts expressed as percentage of applied radioactivity. 

2) Area% of HPLC analysis, 14C trace. 

3) Area%-mean value of two samples. 

Conclusion:

Hydrolysis affects the nature of BYI 08330-keto-hydroxy residues under conditions being representative for 

processing studies. At conditions of pH=4 / 90°C (20 min) no significant hydrolysis was found. At pH=5 / 100 

°C (60 min) ca. 5% degradation was observed. At conditions of pH=6 / 120 °C (20 min) the test item 

degraded nearly completely. BYI 08330-MA amide was identified as the hydrolysis product formed. 
- 147 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.7.1.5 BYI 08330-mono-hydroxy 

Reference: BYI 08330-mono-hydroxy: Aqueous hydrolysis under conditions of 

processing studies 

Author(s), year: Koch, Sur; 2006 

Report/Doc. number: MEF-05/418 

M-267165-01-1 

Guideline(s): EU Council Directive 91/414/EEC as amended by Commission Directive 96/68/EC 

Section 6.5, Subsection 6.5.1. Guideline 7035/VI/95 Revision 5, Appendix E (July 

1997) 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of this study was to describe the degradation behaviour of the BYI 08330-mono-hydroxy in 

buffered drinking water. The experiments were carried out under laboratory conditions which are 

representative for processing operations of raw agricultural commodities. 

Material and methods:

[Azaspirodecenyl-3-14C]-BYI 08330-mono-hydroxy was applied at a concentration of 0.1 mg a.s./L buffer 

solution. To simulate the conditions of processing studies, non-sterilized drinking water was used. The test 

systems were incubated at three representative sets of hydrolysis conditions: 

Pasteurisation: 90 °C at pH 4 for 20 min (water bath); 

Baking, brewing, boiling: 100 °C at pH 5 for 60 min (water bath); and 

Sterilisation: 120 °C at pH 6 for 20 min (autoclave). 

The pH was adjusted to and remained at pH 4, pH 5 and pH 6 (each ± 0.2) as required. The temperatures 

were in the required ranges of 90 ± 3 °C, 100 ± 3 °C and 120 ± 3 °C during the test periods. The periods for 

heating and cooling to the required temperatures prior to and after the incubation, respectively, were not 

regarded as test periods. The test period started, when the required temperature was reached and was 

terminated by cooling down, when the test time was over. 

The 14C-radioactivity of liquid samples was determined by liquid scintillation counting (LSC). 

Quantitative analysis and identification of the test item was performed by TLC- co-chromatography for all 

samples. Identification of the test item was proven by TLC-co-chromatography with the non-labelled 

reference item. 

Findings:

The applied radioactivity was defined as the amount of radioactivity measured in the subsamples taken at 

the beginning of the incubation period. Based on the results of LSC measurements immediately after test 

termination, a radioactivity balance was established for each experiment. The material balances ranged from 

100.0% to 110.2. 

The material balances demonstrate that no radioactivity and no volatile degradation products dissipated from 

the test system. The concentration effect is due to the evaporation of water from the test system during 

processing. 

BYI 08330-mono-hydroxy was stable under conditions at pH=4 / 90°C and pH=5 / 100°C as well as under 

conditions of pH=6 / 120°C. No hydrolysis product was detectable. Since in none of the samples any 

hydrolysis product was detectable, no quantitative evaluation of the TLC-analysis was performed. 

The measured radioactivity in test solutions is presented in Table B.7.7.1.5-1. 
- 148 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.1.5-1: Measured radioactivity in test solutions: 

BYI 08330- mono-hydroxy 

[0.1 mg/L] 

time pH 

/ temp. Total 

[Bq] 

Mean Total 

[Bq] samples 

Test item 

equivalents 

[μg/L] 1)

pH=4 

90 °C 

140.42 

141.25 

140.8 103.3 

pH=5 

100 °C 

143.75 

142.92 

143.3 105.2 

Zero time 

pH=6 

120 °C 

134.58 

143.75 

139.2 102.2 

pH=4 

90 °C 

161.25 

149.17 

155.2 113.9 

pH=5 

100 °C 

146.25 

148.33 

147.3 108.1 

Test termination 

pH=6 

120 °C 

135.00 

143.33 

139.2 102.1 

Conclusion:

BYI 08330-mono-hydroxy remains unaffected under conditions being representative for processing studies. 

Neither at conditions of pH=4 / 90°C (20 min) and pH=5 / 100°C (60 min) nor at conditions of pH=6 / 120°C 

(20 min) the test item was hydrolysed or degraded. 

Overall conclusion on the effects on the nature of the residue during processing:

The behaviour of BYI 08330 and its four metabolites BYI08330-enol, BYI08330-enol-glucoside, BYI08330-

ketohydroxy and BYI08330-monohydroxy in buffer solution in three representative sets of hydrolysis 

conditions was studied: 

 Pasteurisation: 90 °C at pH 4 for 20 min 

 Baking, brewing, boiling: 100 °C at pH 5 for 60 min 

 Sterilisation: 120 °C at pH 6 for 20 min 

At test termination material balances in all tests were in the range of 100-112% of the applied radioactivity 

indicating that no radioactivity dissipated from the test system. 

BYI 08330 was demonstrated to be resistant to hydrolysis under conditions being representative for 

pasteurization. Under conditions representative for baking, boiling and brewing 15 % of BYI 08330 degraded 

to BYI08330-enol. Under conditions of sterilization the active substance was nearly completely hydrolysed to 

BYI08330-enol. BYI 08330-enol was detected as the only hydrolysis product. 

BYI 08330-enol was shown to be resistant to hydrolysis under all test conditions. 

BYI 08330-enol-glucoside was resistant to hydrolysis under conditions representative for pasteurisation. 

Under conditions representative for baking, brewing and boiling ca.10 % of the test substance was 

hydrolysed to BYI 08330-enol. Under conditions of sterilization ca. 40 % of the BYI 08330-enol-glucoside 

was hydrolysed to the enol metabolite. 

BYI 08330-ketohydroxy was demonstrated to be resistant to hydrolysis under conditions of pasteurisation. 

Under conditions of baking, brewing and boiling a slight degradation to BYI 08330-MA-amide was found 

(5%). Under conditions of sterilisation BYI 08330-ketohydroxy was completely hydrolysed to BYI 08330-MAamide. 

BYI 08330-monohydroxy was shown to be resistant under all test conditions. 
- 149 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.7.2 Residue levels - balance studies on set of representative processes 

B.7.7.2.1 Residue levels - balance studies on set of representative processes with relevance 

for PMRA (Canada) and USEPA: 

B.7.7.2.1.1 Apple processed commodities 

Reference: BYI08330 150 OD - Magnitude of the residue on apple processed 

commodities 

Author(s), year: Mackie, S. 2006 

Report/Doc. number: Report No.: RAFNY014, 

Edition Number: M-276832-01-1 

Guideline(s): PMRA Directive 98-02; DACO 7.4.5/EPA OPPTS 860.1520 

GLP: Yes 

Deviations: No 

Validity: Yes 

Material and methods:

A processing trial was conducted to measure the magnitude of spirotetramat (BYI 08330) residue in apples 

and apple processed commodities following treatment of apples with BYI 08330 150 OD. Three airblast 

applications were made to apple trees starting when the apples were about 60% of final size (BBCH 76), with 

a 14-day retreatment interval (RTI). The first application was applied at a rate of 0.793 kg a.i./ha (0.706 lb 

a.i./A). The second and third applications were applied at a rate of 0.701 and 0.700 kg ai/ha/application 

(0.623 and 0.624 lb a.i./A/application), respectively. All applications were made in spray volumes of 35-70 

gallons per acre (GPA). The total seasonal rate was 2.195 kg ai/ha (1.954 lb a.i./A). One control and one 

treated bulk apple samples were collected at a 7-day pre-harvest interval (PHI) and hand delivered on the 

same day to the processing facility. Prior to processing, random subsamples of the control and treated bulk 

apple samples were collected for analysis, and the remainder of the apple samples were used to generate 

the required processed commodities of apple wet pomace and juice. In addition, samples of washed fruit, 

peeled fruit, applesauce, and dried fruit were generated for use in the dietary risk assessment for 

spirotetramat. Processing was performed using procedures which simulated commercial processing 

practices. 

The total residue of spirotetramat and the metabolites was quantitated by high-performance liquid 

chromatography with tandem mass spectrometry (HPLC-MS/MS) method 00857 using isotopically labeled 

internal standards. Method validation was performed prior to sample analysis and concurrent recoveries 

were performed during sample analysis to demonstrate acceptable method performance. The individual 

analyte residues of spirotetramat (parent) and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 

08330-mono-hydroxy and BYI 08330-enol-glucoside, were summed to give a total spirotetramat residue in 

parent equivalents. The limit of quantitation (LOQ) was 0.010 ppm for each analyte in apple fruit and

processed apple commodities. 

The maximum interval of frozen storage for apple fruit and all processed commodities was 34-90 days. 

Storage stability data indicated that the combined residues of spirotetramat and the associated metabolites 

are stable in plant matrices for up to 718 days. Similarly, storage stability data for orange juice and dried 

prunes indicated that total residues of spirotetramat were stable for at least 147 days. Therefore, the length 

of frozen storage of apple commodities would not affect the magnitude of total spirotetramat residues 

observed. 
- 150 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Findings: 

The total spirotetramat residues were 0.681 ppm in treated apples and were found to concentrate in apple 

wet pomace (1.9-fold). No concentration (<onefold) of the total spirotetramat residue was found in apple 

juice (0.4-fold), washed fruit (0.6-fold), peeled fruit (0.2-fold), applesauce (0.1-fold), or dried fruit (onefold). 

These factors are less than the maximum concentration factor for apples (14-fold for pomace). 

Conclusion:

Washing and peeling of apples did not result in concentration of residues, nor did processing of apples into 

applesauce, juice or dried fruit. Total spirotetramat residues did concentrate slightly in apple wet pomace 

(1.9-fold). These factors are less than the maximum concentration factor for apples (14-fold for pomace). 

Comments (RMS):

None. 

B.7.7.2.1.2 Citrus Processed Commodities 

Reference: Amended Report BYI08330 150 OD - Magnitude of the Residue on Citrus 

Processed Commodities.

Author(s), year: Lenz, C. 2006 

Report/Doc. number: Report No.: RAFNY016, 

Edition Number: M-277028-01-1 

Guideline(s): PMRA Directive 98-02; DACO 7.4.5/EPA OPPTS 860.1520 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Reference: BYI08330 100 OD - Reduction of the Residue in Grapefruit from Commercial 

Washing, Waxing, and Packing Procedures. 

Author(s), year: Krolski, M. E., 2006 

Report/Doc. number: Report No.: RAFN042, 

Edition Number: M-276675-01-1 

Guideline(s): PMRA Directive 98-02; DACO 7.4.5/EPA OPPTS 860.1520 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Material and methods:

An orange processing trial was conducted to measure the magnitude of residue on oranges and orange 

processed commodities. Two foliar applications of spirotetramat 150 OD (oil-dispersible) were made to

oranges at a rate of 0.756 to 0.783 lb a.i./A/application (0.848 to 0.878 kg a.i./ha/application) with 19 to 21 

days between applications and a preharvest interval (PHI) of 1-day. The total amount of spirotetramat

applied was 1.54 lb a.i./A (1.726 kg a.i./ha). 

A single control and treated bulk sample of oranges were collected at BBCH 83 (fruit ripe for picking has not 

yet developed variety specific coloration) to BBCH 89 (fruit ripe for consumption) at a 1-day target PHI. Prior 

to processing, random sub-samples of the control and treated bulk orange samples were collected for 

analysis, and the remainder of the orange samples were used to generate the required processed 

commodities of dried pulp, oil, and juice. Processing was performed using procedures which simulated 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

commercial processing practices. The resultant orange raw agricultural commodity (RAC) samples and 

orange processed commodities were analyzed to determine total spirotetramat residue. Difficulties in 

generating the orange oil processed commodity were encountered during processing which resulted in 

decreased amounts of orange oil sample available for analysis. 

The total residue of spirotetramat and the metabolites was quantitated by high-performance liquid 

chromatography with tandem mass spectrometry (HPLC-MS/MS) method 00857 using isotopically labeled 

internal standards. Method validation and concurrent recoveries were performed to demonstrate acceptable 

method performance. The individual analyte residues of spirotetramat (parent), BYI 08330-enol, BYI 08330-

ketohydroxy, BYI 08330-mono-hydroxy and BYI 08330-enol-glucoside were summed to give a total 

spirotetramat residue in parent equivalents. The limit of quantitation (LOQ) was 0.05 ppm for each analyte in 

oranges and the processed commodities of oranges. 

A second study conducted on grapefruit was also submitted. The study was conducted to evaluate the 

reduction of spirotetramat residue in grapefruit following commercial washing and waxing procedures. A 

single foliar spray application of spirotetramat 100 OD was made to grapefruit trees 7 days before fruit 

harvest at a target rate of 0.314 lb a.i./acre (0.352 kg a.i./ha), with the spray adjuvant Dyne-amic at a rate of 

0.25% (v/v). Grapefruit was collected from both the treated plot and the control plot at a 7-day PHI and the 

samples were washed and waxed following typical commercial citrus processing practices. Triplicate 

samples from the treated plot and a single sample from the control plot were collected before and after the 

washing and waxing process. 

The total residue of spirotetramat (parent and the metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 

08330-mono-hydroxy, and BYI 08330-enol-glucoside) was quantitated by method 00857 (LC-MS/MS) using 

isotopically labeled internal standards. The LOQ was 0.01 ppm for each individual analyte in grapefruit. 

Findings: 

Concentration (13.5-fold) of the total spirotetramat residue was observed in the processed commodity of 

orange oil. A slight concentration of total BYI 08830 residues was observed in orange dried pulp (1.3-fold) 

and no concentration (0.40-fold) of total spirotetramat residue was observed in orange juice. These factors 

are within the theoretical concentration factors (1000-fold for citrus oil and 2-fold for juice). The total residues 

of spirotetramat and the metabolites BYI 08330-enol, - ketohydroxy, -mono-hydroxy, and -enol-glucoside

were quantitated and unwashed grapefruit contained average total spirotetramat residues of 0.061 ppm. A 

processing factor of 0.10-fold was determined from samples collected before and after the washing and 

waxing process in grapefruit. 

The maximum intervals of frozen storage for orange fruit, juice, dried pulp and oil were 169, 44, 23 and 12 

days, and for grapefruit were 176 days. Storage stability data indicated that residues of spirotetramat and 

the associated metabolites are stable for up to 24 months (718 days). Similarly, storage stability data 

indicated that total residues of spirotetramat were stable for at least 5 months (147 days). Since orange pulp 

and oil were analyzed within 30 days after their generation, storage stability data for these processed 

commodities was not required. Therefore, the intervals of frozen storage for any of the orange or grapefruit 

commodities tested here would not have affected the levels of total spirotetramat residues observed. 

Conclusion:

Mean total residues of spirotetramat in orange fruit were 0.62 ppm. Processing of oranges into dried pulp 

and oil resulted in residues concentrating 1.3-fold and 13.5-fold, respectively. No concentration of residues 

was observed in juice (0.40-fold decrease). These factors conform with the theoretical concentration factors 

(1000-fold for citrus oil and 2-fold for juice). Total spirotetramat residues in washed and waxed grapefruit 
- 152 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

decreased by a factor of 0.10-fold. 

Comments (RMS):

None. 

B.7.7.2.1.3 Grapes Processed Commodities 

Reference: BYI08330 150 OD - Magnitude of the Residue in/on Grapes Processed 

Commodities 

Author(s), year: Mosier, D. 2006 

Report/Doc. number: Report No.: RAFNY015, 

Edition Number: M-277287-01-1 

Guideline(s): PMRA Directive 98-02; DACO 7.4.5/EPA OPPTS 860.1520 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Material and methods:

A grape processing trial was conducted to measure the magnitude of spirotetramat residues in grapes and 

grape processed commodities following treatment of grapes with spirotetramat 150 OD (oil-dispersible). Two 

airblast applications of spirotetramat 150 OD were made to grapes at a rate of 0.487 - 0.491 lb a.i./A (0.546 – 

0.550 kg a.i./ha) with a 28 to 30-day interval and a preharvest interval (PHI) of 5 to 7 days. The total 

seasonal rate was 0.982 lb a.i./A (1.100 kg a.i./ha) for the treated plots. Spray volumes ranged from 55.87 

gallons per acre (GPA) (522.6 L/ha) to 56.54 GPA (528.9 L/ha). Each application was made with Dyne-Amic 

adjuvant (0.25% v/v) at concentrated spray volume of 35 to 70 GPA. 

A single control and a treated bulk sample of grapes were collected at the fully ripe fruit stage (BBCH 89) (6-

day target PHI). Prior to processing, random subsamples of the control and treated bulk grape samples

were collected for analysis, and the remainder of the grape samples were used to generate the required

processed commodities of raisins and juice. Washed grapes and grape jelly processing was performed 

using procedures which simulated commercial processing practices. 

The total residue of spirotetramat and the metabolites was quantitated by high-performance liquid 

chromatography with tandem mass spectrometry (HPLC-MS/MS) method 00857 using isotopically labeled 

internal standards. Method validation and concurrent recoveries were performed to demonstrate acceptable 

method performance. Individual analyte residues of spirotetramat, BYI 08330-enol, and BYI 08330-

ketohydroxy, BYI 08330-monohydroxy, and BYI 08330-enol glucoside were summed to give a total 

spirotetramat residue in parent equivalents. The limit of quantitation (LOQ) was 0.01 ppm for each analyte in 

grapes and the processed commodities of grapes. 

Findings: 

Following the exaggerated use of spirotetramat 150 OD on grapes and subsequent processing of grapes into 

the required commodities, the total spirotetramat residue was found to concentrate in raisins (2.61-fold). No 

concentration (<1-fold) of total spirotetramat residue was observed in grape juice (0.66-fold), jelly (0.28-fold) 

or washed berries (0.60-fold). 

The maximum interval of frozen storage for grapes and processed grape commodities was 179 days. 

Separate storage stability studies indicate that residues of spirotetramat and the metabolites BYI 08330-enol, 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

-ketohydroxy, -mono-hydroxy and -enol-Glc are stable in raw agricultural commodities for up to 24 months 

(718 days) and in processed commodities (orange juice and prune fruit) for up to 5 months (147 days). 

Conclusion:

Total spirotetramat residues were shown to concentrate in raisins (2.61-fold), and decreased in washed

grapes (0.60-fold), juice (0.66 fold) and jelly (0.28-fold). These factors are within the theoretical

concentration factors (4.7-fold for raisins and 1.2-fold for juice). 

Comments (RMS):

None. 

B.7.7.2.1.4 Hop Cone, Green, Processing and Processed Fractions 

Reference: Determination of the Residues of BYI 08330 in/on Hop Cone, Green, for 

Processing and the Processed Fractions (Cone, Kiln-Dried; Beer; Hops 

Draff; Brewer’s Yeast; Brewer’s Malt) after Spraying of BYI 08330 (100 OD) in 

the Field in Northern France and Germany. 

Author(s), year: Schöning, R., Billian, P., Helfrich, P. 2006 

Report/Doc. number: Report No.: RA-3036/04 

Edition Number: M-265067-01-2 

Guideline(s): PMRA Directive 98-02; DACO 7.4.5/EPA OPPTS 860.1520 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Material and methods:

The purpose of the presented study was to determine the transfer of spirotetramat (100 OD, an oildispersible formulation containing 100 g a.i./L) and its metabolites (BYI 08330-enol, BYI 08330-ketohydroxy, 

BYI 08330-mono-hydroxy and BYI 08330-enol-Glc) from green hop cones via kiln-dried hop cones into hop 

processed commodities (beer) and by-products obtained during brewing processing (hops draff; brewer’s 

yeast; brewer’s malt). From each trial, a treated hop cone sample was taken for processing. Green cone 

samples were dried until approx. 10% remaining moisture to produce kiln-dried hop cones samples for 

processing using simulated commercial procedures. 

Method 00857 was used to determine the total residues of spirotetramat and its metabolites in hop cones, 

beer, hop draff, and brewer’s yeast. Adequate method-validation data were provided. 

 

Findings:

Total residues of spirotetramat and the metabolites in green cones ranged from 0.66-1.2 ppm. In kiln-dried 

cones, total residues of spirotetramat ranged from 1.64-4.34 ppm. In all processed commodities tested

(beer, brewer’s yeast, brewer’s malt), total residues of spirotetramat decreased (<1-fold) relative to kiln dried 

cones. 

 

The maximum period of frozen storage for hops cones (green and dried) was 352-358 days, which was 

within the demonstrated period of storage stability for total spirotetramat residues (18 months). The

maximum period of frozen storage for hops draff, brewer’s yeast, brewer’s malt and beer was 105, 74, 95 

and 67 days, respectively, also within the demonstrated period of storage stability for total spirotetramat 

residues. 
- 154 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Conclusion:

All processed fractions of hops showed a decrease in the total spirotetramat residues relative to-kiln dried 

cones. 

Comments (RMS):

None. 

B.7.7.2.1.5 Plum Processed Commodities 

Reference: BYI 08330 150 OD: Magnitude of the Residue on Plum Processed 

Commodities 

Author(s), year: Mackie, S. 2006 

Report/Doc. number: Report No.: RAFNY018, 

Edition Number: M-276380-01-1 

Guideline(s): PMRA Directive 98-02; DACO 7.4.5/EPA OPPTS 860.1520 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Material and methods:

A plum processing trial was conducted to measure the magnitude of total spirotetramat residues in plums 

and plum processed commodities following treatment of plums with BYI 08330 150 OD (oil-dispersible). 

Three airblast applications were made to plum trees. The first application was made when the plums were at 

the beginning of fruit colouring stage, with a 14-day interval between the two succeeding applications. The 

first application was made at a rate of 0.704 lb a.i./A/application (790 g a.i./ha/application). The second and 

third test substance applications were made at a target rate of 0.492 lb a.i./A/application (551 g 

a.i./ha/application) in target spray volumes of 35-70 gallons per acre (GPA). The achieved total seasonal 

rate was 1.69 lb a.i./A (1892 g a.i./ha). 

One control and one treated bulk plum samples were collected at a 7-day pre-harvest interval (PHI) and

shipped on the same day to the processing facility. Prior to processing, random sub-samples of the control 

and treated bulk plum samples were collected for analysis, and the remainder of the plum samples was used 

to generate the required processed commodities of prunes. In addition, samples of washed plum fruit were 

generated. 

The total residue of spirotetramat and the metabolites was quantitated by high-performance liquid 

chromatography with tandem mass spectrometry (HPLC-MS/MS) method 00857 using isotopically labeled 

internal standards. Method validation was performed prior to sample analysis and concurrent recoveries 

were performed during sample analysis to demonstrate acceptable method performance. The individual 

analyte residues of spirotetramat (parent) and the metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 

08330-mono-hydroxy and BYI 08330-enol-glucoside, were summed to give a total spirotetramat residue in 

parent equivalents. The limit of quantitation (LOQ) was 0.01 ppm for each analyte in the plum raw 

agricultural commodity (RAC) and each processed commodity. 

Findings: 

The maximum interval of frozen storage for plum fruit and all processed commodities ranged from 84 days to 

140 days. Storage stability data indicated that the combined residues of spirotetramat and the associated 

metabolites are stable in plant matrices for up to 24months (718 days). Similarly, storage stability data for 

orange juice and dried prunes indicated that total residues of spirotetramat were stable for at least 5 months 
- 155 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

(147days). 

The total spirotetramat residue was found to concentrate in prunes (2.2-fold). No concentration (<1-fold) of 

total spirotetramat residue was found in washed plum fruit (0.9-fold). 

Conclusion:

Plums washed and processed into prunes had processing factors of 0.9-fold and 2.2-fold, respectively. 

These factors were within the theoretical concentration factor (3.4-fold for prunes). 

Comments (RMS):

None. 

B.7.7.2.1.6 Potato Processed Commodities 

Reference: BYI 08330 150OD - Magnitude of the Residue on Potato Processed 

Commodities. 

Author(s), year: Lenz, C. 2006 

Report/Doc. number: Report No.: RAFNY020, 

Edition Number: M-276828-01-1 

Guideline(s): PMRA Directive 98-02; DACO 7.4.5/EPA OPPTS 860.1520 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Material and methods:

A potato processing trial was conducted to measure the magnitude of spirotetramat residue on potatoes and 

potato processed commodities. Two foliar applications of spirotetramat 150 OD (oil-dispersible) were made 

to potatoes at a rate of ~0.450 kg a.i./ha (0.40 lbs. a.i./A) with 7 days between applications. A single control 

and a treated bulk sample of potatoes were collected at a 7-day pre-harvest interval (PHI). Prior to 

processing, random sub-samples of the control and treated bulk potato samples were collected for analysis, 

and the remainder of the potato samples were used to generate the required processed commodities of wet 

peel, chips, and granules. 

In addition, samples of washed potatoes, cooked potatoes, and potato tuber without peel were generated for 

use in the dietary risk assessment for spirotetramat. Potato processing was performed using procedures 

which simulated commercial processing practices. The resultant potato samples and processed 

commodities were analyzed to determine total residues of spirotetramat and its metabolites. The potato 

tuber raw agricultural commodity (RAC) and processed commodities were held in frozen storage for a 

maximum of <1 month (8-13 days) prior to analysis. Storage stability data for the processed commodities 

are thus not required. 

The total residue of spirotetramat and the metabolites was quantitated by high-performance liquid 

chromatography with tandem mass spectrometry (HPLC-MS/MS) method 00857 using isotopically labeled 

internal standards. Method validation and concurrent recoveries were performed to demonstrate acceptable 

method performance. The individual analyte residues of spirotetramat (parent), BYI 08330-enol, BYI 08330-

ketohydroxy, BYI 08330-mono-hydroxy and BYI 08330-enol-glucoside were summed to give a total 

spirotetramat residue in parent equivalents. The limit of quantitation (LOQ) was 0.01 ppm for each analyte in 

potatoes and the processed commodities of potatoes.
- 156 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Findings:

The maximum concentration of total spirotetramat residues was observed in processed potato flakes (3.5-

fold). A slight concentration of total spirotetramat residue was observed in potato chips (1.2-fold) and no 

concentration of total spirotetramat residue was observed in potato wet peel (1-fold). 

Conclusion:

The processing factors observed are within the theoretical concentration factors (4.7-fold for flakes and 4-fold 

for processed waste). 

Comments (RMS):

None. 

B.7.7.2.1.7 Tomato Processed Commodities 

Reference: BYI08330 100 OD - Magnitude of the residue on tomato processed 

commodities 

Author(s), year: Mackie, S. J. W. 2006 

Report/Doc. number: Report No.: RAFNY013, 

Edition Number: M-277034-01-1 

Guideline(s): PMRA Directive 98-02; DACO 7.4.5/EPA OPPTS 860.1520 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Material and methods:

A tomato processing trial was conducted to measure the magnitude of spirotetramat (BYI 08330) residue in 

tomatoes and tomato processed commodities. Two broadcast foliar applications of BYI 08330 100 OD (oildispersion containing 100 g/L or 0.83 lb/gallon spirotetramat) were made to tomato plants. The first 

application was made when 20% of the tomatoes showed typical full ripe colour (BBCH 82), with a 7-day 

interval between the two applications. The two applications were applied at a rate of 0.397-0.440 lb 

a.i./A/application (0.445-0.449 kg a.i./ha/application). One control and one treated bulk tomato sample were 

collected at a 3-day pre-harvest interval (PHI). Prior to processing, random sub samples of the control and 

treated bulk tomato samples were collected for analysis, and the remainder of the tomato samples were 

used to generate the required processed commodities of purée, paste, and juice. In addition, samples of 

washed tomatoes, cooked (hot crushed) tomatoes, canned tomatoes, and dried tomatoes were generated. 

The total residue of spirotetramat and the metabolites was quantitated by high-performance liquid 

chromatography with tandem mass spectrometry (HPLC-MS/MS) method 00857 using isotopically labelled 

internal standards. Method validation was performed prior to sample analysis and concurrent recoveries 

were performed during sample analysis to demonstrate acceptable method performance. The individual 

analyte residues of spirotetramat (parent) and the metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI 

08330-mono-hydroxy and BYI 08330-enol-glucoside, were summed to give a total spirotetramat residue in 

parent equivalents. The limit of quantitation (LOQ) was 0.01 ppm for each analyte in the tomato raw 

agricultural commodity (RAC) and each processed commodity. 

Findings: 

The total spirotetramat residue was found to concentrate in dried tomatoes (12-fold), tomato paste (7.4-fold) 

and in tomato purée (3.5-fold). No concentration (<1-fold) of the total spirotetramat residue was found in 
- 157 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

tomato juice (0.9-fold). In the addition, the total spirotetramat residue was found to concentrate in canned 

tomatoes (1.1-fold) and dried tomatoes (12-fold). No concentration (≤1-fold) of total spirotetramat residue 

was found in the washed tomatoes (0.7-fold), or cooked (hot crushed) tomatoes (0.6-fold). 

Conclusion:

The processing factors observed in some cases exceed the theoretical concentration factors for tomato (1.4-

fold for purée, 1.4-fold for juice, and 5.5-fold for paste). 

Comments (RMS):

None. 

Overall conclusion: 

Acceptable apple, orange, grape, plum, potato, hop and tomato processing studies are available. The 

processing studies show that following processing of RAC samples bearing quantifiable residues, total 

residues of spirotetramat and the metabolites concentrated in apple wet pomace (1.9-fold), citrus oil (13.5-

fold), orange dried pulp (1.3-fold), raisins (2.6-fold), prunes (2.2-fold), potato flakes (3.5-fold), potato chips 

(1.2-fold), dried tomatoes (12-fold), tomato paste (7.4-fold) and tomato purée (3.5-fold). MRLs will only be 

necessary for potato flakes, raisins, and citrus oil. 
- 158 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.7.2.2 Residue levels - balance studies on set of representative processes with relevance 

for the European Community (EU) 

B.7.7.2.2.1 Orange juice and marmalade 

Reference: Determination of the residues of BYI 08330 in/on orange fruit and the 

processed fractions (pulp, peel, raw juice; pomace wet, washings, fruit 

washed, marmalade, peelwashed, fruit peeled, strain rest, peel dried, 

pomace dried) after spraying of BYI 08330 (100 OD) in the field in Italy, 

Portugal and Spain 

Author(s), year: Schoening R., Helfrich P.; 2006 

Report/Doc. number: RA-3032/04, including samples from trials no. R 2004 0139/6, R 2004 0141/8, R 

2004 0239/2, R 2004 0240/6 

M-263630-01-1 

Guideline(s): EU Council Directive 91/414/EEC of July15, 1991, Annex II, part A, section 6 and 

Annex III, part A, section 8: Residues in or on treated products, food and feed 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of the presented study was to determine the transfer of BYI 08330 and its metabolites 

(BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy and BYI08330-enol-Glc) from orange fruit 

into processed fractions after processing of orange fruits to juice and marmalade. 

Material and methods:

Orange fruit samples from four field trials that were performed in Italy, Portugal and Spain as part of study 

RA-2032/04 with BYI 08330 (100 OD) were processed. From each of the 4 trials two fruit samples (one for 

juice processing and one for marmalade processing) have been taken. Information about the treated plots is 

given in Table B.7.7.2.2.1-1. 

Table B.7.7.2.2.1-1: Application Data Summary in/on Orange in Southern Europe. 

Country Trial No. Number Formulation Kg a.s./ha 

Kg a.s./ha x m 

*) 

Growth stage 

BBCH 

Italy 

R 2004 0139/6 

2 OD 100 0.2112 0.096 87 

Italy 

R 2004 0141/8 

2 OD 100 0.2300 0.096 85-88 

Portugal 

R 2004 0239/2 

2 OD 100 0.2880 0.096 81-83 

Spain 

R 2004 0240/6 

2 OD 100 0.2880 0.096 79-81 

*) Rate per m height of leafy surface 

Preparation of processed fractions:

The oranges were processed simulating industrial procedures, whereby the degradation of the active 

ingredients was kept to a minimum (worst case situation). This was achieved by a minimum of processing

steps. Basis of the juice processing was the squeezing of orange halves by means of an electrical juice 

squeezer. The marmalade was produced by cooking the orange pulp and cut orange peel with jam sugar. 
- 159 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.2.2.1-2: Preparation of orange (RAC) to processed fractions: 

Production of orange juice Production of orange marmalade 

Defrosting: 

The orange specimens were defrosted at room 

temperature. 

Defrosting: 

The orange specimens were defrosted at room 

temperature. 

Washing: 

The oranges were cleaned in two steps with tap water. 

The washed oranges were used for the preparation of

juice and of additional products. An aliquot of washed 

fruit and washings (washing water) was taken as a 

specimen. 

Washing: 

The oranges were cleaned in two steps with tap water. 

The washed oranges were used for the preparation of the 

marmalade. 

Extraction of the juice: 

A portion of the washed oranges was cut into halves and 

squeezed using a citrus juice squeezer. The peel with rest 

of the endocarp remaining after squeezing gave the 

fraction peel, washed. Pomace (seeds and the orange 

flesh) was separated by sieving the juice through a

colander. The pomace was centrifuged (= pomace, wet). 

The supernatant juice was combined with the squeezed 

juice to the raw juice. A portion of the pomace, wet and a 

portion of the peel, washed was dried in the range of 40 to 

80°C1 until the water content is close to 10 %. 

An aliquot of the following fractions was taken as a

specimen: raw juice, washed peel, dried peel; wet 

pomace, and dried pomace. 

Peeling of the oranges: 

The oranges were manually peeled. Approx. 3.8 – 5.3 kg 

of peeled fruit and 1.7 to 2.4 kg of peel were produced. 

The peel was cut into strips. 

An aliquot of peeled fruit and washed peel were taken as 

specimens. 

Homogenisation of the oranges: 

The peeled oranges were cut into pieces. The pieces were 

homogenised using a food processor (cutter).The 

homogenised oranges were heated to approx. 100°C. The 

heated homogenate was sieved through a colander at a 

temperature range of 57 to 81°C. The orange pulp without 

seed and crude parts of the fruit was used for the 

preparation of the marmalade. An aliquot of the remaining 

on the colander (strain rest) was taken as a specimen. 

Pasteurisation: 

The raw juice was transferred into glass bottles (1 L) and 

tightly closed. The bottles were heated within 45 to 60 min 

from 27 – 31°C to approx. 80°C. After 15 min at 82 to 

86°C (final temperature) they were cooled down to room 

temperature over night. 

An aliquot of the juice (pasteurised) was taken as a 

specimen. 

Preparation of the marmalade: 

The marmalade consisted of 65 % jam sugar, 10 % peel 

and 25 % orange pulp (e.g. 4875 g of sugar were 

combined with 750 g of peel and 1875 g of orange pulp). 

The mixture was heated in a cooking pot under stirring. 

The marmalade was cooked for a few minutes (10 – 15

min.). At the end the marmalade was transferred into jam 

jars and cooled down to room temperature over night. 

An aliquot of the marmalade was taken as a specimen. 

Residues of BYI 08330 and its metabolites BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy 

and BYI08330-enol-Glc in/on orange (fruit; raw juice; juice; pomace, wet; washings; fruit, washed; pomace, 

dried; peel, dried; peel, washed; marmalade; fruit, peeled; strain rest) were determined by HPLC-ESIMS/MS. 

The Limit of Quantitation (LOQ), defined as the lowest validated fortification level (calculated as BYI 08330 

equivalents), was 0.01 mg/kg (BYI 08330), 0.012 mg/kg (BYI08330-enol, BYI08330-ketohydroxy, BYI08330-

mono-hydroxy) and 0.008 mg/kg (BYI08330-enol-Glc) in/on orange (fruit; raw juice; juice; pomace, wet; 

washings; fruit, washed; pomace, dried; peel, dried; peel, washed; marmalade; fruit, peeled; strain rest). The 

LOQ for the total residue of BYI 08330 (sum of single analyte residues, each calculated as BYI 08330 

equivalents) was calculated as 0.054 mg/kg in/on orange (fruit; raw juice; juice; pomace, wet; washings; fruit, 

washed; pomace, dried; peel, dried; peel, washed; marmalade; fruit, peeled; strain rest). 

Procedural recoveries:

Recovery findings in the different processed matrices were within guideline requirements (70-110%, RSD

<20%). Recovery results are summarized in Table B.7.7.2.2.1-3. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.2.2.1-3: Recovery results (concurrent recoveries) for determination of BYI 08330 and its 

metabolites in orange fruit and in processed commodities 

Sample 

Material Orange Fruit 1) Orange Peel 2) Orange Juice 3) Orange Wet 

Pomace 4)

Orange 

Marmalade 

Analyte 

Fortification 

levels *) 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

BYI 08330 0.01 

1.0 

88 ± 

13.0 

(n=15) 

0.01 

002 

1.0 

83 ± 

12.5 

(n=16) 

0.01 

1.0 

83 ± 

9.8 

(n=8) 

0.01 

1.0 

81 ± 

9.8 

(n=8) 

0.01 

1.0 

90 ± 

5.7 

(n=8) 

BYI08330-

enol 

0.01 

1.0 

86 ± 

9.9 

(n=15) 

0.01 

002 

1.0 

82 ± 

11.9 

(n=16) 

0.01 

1.0 

83 ± 

10.0 

(n=8) 

0.01 

1.0 

82 ± 

12.5 

(n=8) 

0.01 

1.0 

90 ± 

4.9 

(n=8) 

BYI08330-

ketohydro

xy 

0.01 

1.0 

85 ± 

9.1 

(n=8) 

0.01 

002 

1.0 

82 ± 

12.1 

(n=8) 

0.01 

1.0 

83 ± 

12.4 

(n=8) 

0.01 

1.0 

81 ± 

11.4 

(n=8) 

0.01 

1.0 

88 ± 

6.1 

(n=8) 

BYI08330-

monohydroxy 

0.01 

1.0 

85 ± 

10.3 

(n=15) 

0.01 

002 

1.0 

83 ± 

12.1 

(n=16) 

0.01 

1.0 

81 ± 

9.6 

(n=8) 

0.01 

1.0 

80 ± 

12.9 

(n=8) 

0.01 

1.0 

88 ± 

7.0 

(n=8) 

BYI08330-

enol-Glc 

0.01 

1.0 

86 ± 

9.9 

(n=15) 

0.01 

002 

1.0 

83 ± 

11.0 

(n=16) 

0.01 

1.0 

79 ± 

13.5 

(n=8) 

0.01 

1.0 

83 ± 

11.3 

(n=8) 

0.01 

1.0 

90 ± 

7.2 

(n=8) 

1) Sample material fruit covers sample materials pulp; fruit, washed; fruit, peeled. 

2) Sample material peel covers sample materials peel, dried; peel, washed. 

3) Sample material juice covers sample materials raw juice; washings. 

4) Sample material pomace, wet covers sample materials pomace, dried; strain rest. 

*) levels refer to fortification with individual analytes (not calculated as BYI 08330 equivalents). 

Findings:

The total residue of BYI08330 in orange fruit used for processing ranged between <0.054 mg/kg (LOQ) and 

0.18 mg/kg. In orange juice from all 4 orange fruit samples a total residue of below the LOQ of 0.054 mg/kg 

was detected. In orange marmalade the total residue of BYI 08330 ranged between <0.054 and 0.067 

mg/kg. The residue results for the different processed fractions are given in Table B.7.7.2.2.1-4 and Table 

B.7.7.2.2.1-5. 

Table B.7.7.2.2.1-4: Residues of BYI 08330 in orange fruit and in processed commodities from 

orange juice processing 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Italy 

R 2004 

0139/6 

fruit 

raw juice 

juice 

pomace, wet 

washings 

fruit, washed 

pomace, dried

peel, dried 

peel, washed 

14 0.02

0.01

<0.01

<0.01

0.01

0.01

0.01

0.02

0.02 

0.012

<0.012

<0.012

<0.012

<0.012

0.012

0.014

0.16

0.018 

0.012

0.012

<0.012

<0.012

0.012

0.012

0.013

0.097

0.019 

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012 

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008 

<0.054

<0.054

<0.054

<0.054

<0.054

<0.054

<0.054

0.27

0.057
- 161 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Italy 

R 2004 

0141/8 

fruit 

raw juice 

juice 

pomace, wet 

washings 

fruit, washed 

pomace, dried

peel, dried 

peel, washed 

21 0.02

<0.01

<0.01

<0.01

<0.01

0.01

<0.01

0.03

0.01 

0.014

<0.012

<0.012

<0.012

<0.012

0.013

0.016

0.094

0.024 

0.012

<0.012

<0.012

<0.012

<0.012

0.012

0.012

0.042

0.013 

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012 

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008

0.012

0.008 

<0.054

<0.054

<0.054

<0.054

<0.054

<0.054

<0.054

0.18

0.059

Portugal 

R 2004 

0239/2 

fruit 

raw juice 

juice 

pomace, wet 

washings 

fruit, washed 

pomace, dried

peel, dried 

peel, washed 

14 0.04

<0.01

<0.01

<0.01

<0.01

0.02

0.01

0.07

0.03 

0.041

<0.012

<0.012

<0.012

<0.012

0.036

0.041

0.26

0.059 

0.012

<0.012

<0.012

<0.012

<0.012

0.013

0.012

0.083

0.024 

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012 

0.008

<0.008

<0.008

<0.008

<0.008

0.008

<0.008

0.018

0.008 

0.099

<0.054

<0.054

<0.054

<0.054

0.073

0.062

0.43

0.12

Spain 

R 2004 

0240/6 

fruit 

raw juice 

juice 

pomace, wet 

washings 

fruit, washed 

pomace, dried

peel, dried 

peel, washed 

21 0.08

0.01

0.01

0.01

0.02

0.04

0.01

0.15

0.06 

0.078

0.030

0.026

0.041

0.012

0.062

0.22

0.36

0.073 

0.012

<0.012

<0.012

<0.012

<0.012

0.012

0.012

0.064

0.016 

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012 

0.016

0.008

0.008

0.008

<0.008

0.017

0.019

0.063

0.020 

0.18

<0.054

<0.054

0.059

<0.054

0.13

0.26

0.64

0.17

Table B.7.7.2.2.1-5: Residues of BYI 08330 in orange fruit and in processed commodities from orange 

marmalade processing 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Italy 

R 2004 

0139/6 

fruit 

peel, washed 

marmalade 

fruit, peeled 

strain rest 

14 0.02

0.06

<0.01

<0.01

<0.01 

0.012

0.030

<0.012

<0.012

<0.012 

0.012

0.034

<0.012

<0.012

<0.012 

<0.012

<0.012

<0.012

<0.012

<0.012 

<0.008

<0.008

<0.008

<0.008

<0.008 

<0.054

0.12

<0.054

<0.054

<0.054

Italy 

R 2004 

0141/8 

fruit 

peel, washed 

marmalade 

fruit, peeled 

strain rest 

21 0.02

0.02

<0.01

<0.01

<0.01 

0.014

0.027

<0.012

<0.012

<0.012 

0.012

0.013

<0.012

<0.012

<0.012 

<0.012

<0.012

<0.012

<0.012

<0.012 

<0.008

0.008

<0.008

<0.008

<0.008 

<0.054

0.067

<0.054

<0.054

<0.054

Portugal 

R 2004 

0239/2 

fruit 

peel, washed 

marmalade 

fruit, peeled 

strain rest 

14 0.04

0.04

0.01

<0.01

<0.01 

0.041

0.080

0.013

<0.012

<0.012 

0.012

0.031

0.012

<0.012

<0.012 

<0.012

<0.012

<0.012

<0.012

<0.012 

0.008

0.008

<0.008

<0.008

<0.008 

0.099

0.16

<0.054

<0.054

<0.054
- 162 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Spain 

R 2004 

0240/6 

fruit 

peel, washed 

marmalade 

fruit, peeled 

strain rest 

21 0.08

0.14

0.01

0.01

0.01 

0.078

0.11

0.036

0.064

0.054 

0.012

0.034

0.012

<0.012

<0.012 

<0.012

<0.012

<0.012

<0.012

<0.012 

0.016

0.046

0.008

0.010

0.008 

0.18

0.33

0.067

0.084

0.072

Based on the residue levels in the treated processing products transfer factors were calculated. The transfer 

factors for the processing products are calculated according to the following equation: 

Transfer Factor = Residue concentration in the processed product [mg/kg] / Residue concentration in the 

RAC [mg/kg] 

Transfer factors are calculated on a worst-case basis. For this purpose, residues < LOQ are set at the LOQ. 

A mean average factor of 0.5 was calculated for the transfer of the total residue of BYI08330 from orange 

fruit into orange juice and orange marmalade. The transfer factors are summarized in Table B.7.8.1.1-6. No 

transfer factors could be calculated for processed commodities from two trials (R 2004 0139/6 and R 2004 

0141/8), because the total residue of BYI08330 in orange fruit and in processed commodities was below the 

LOQ. 

Table B.7.7.2.2.1-6: Transfer factors for the total residue of BYI08330 into processed commodities 

related to orange fruit 

Transfer Factors for Total Residue of BYI08330 Sample material 

R 2004 0239/2 R 2004 0240/6 mean 

washings 0.6 0.3 0.5 

fruit, washed 0.7 0.7 0.7 

raw juice 0.6 0.3 0.5 

peel, washed 1.2 0.9 1.1 

peel, dried 4.3 3.6 4.0 

pomace, wet 0.6 0.3 0.5 

pomace, dried 0.6 1.4 1.0 

Orange juice 

juice 0.6 0.3 0.5 

peel, washed 1.6 1.8 1.7 

fruit, peeled 0.6 0.5 0.6 

strain rest 0.6 0.4 0.5 

Orange marmalade 

marmalade 0.6 0.4 0.5 

Conclusion: 

As an average factor of 0.5 could be calculated for the transfer of the total residue of BYI08330 from orange 

fruit into orange juice and orange marmalade, no concentration of BYI08330 is to be expected during 

processing of oranges to juice and marmalade. Concentration was observed in peel; however, these results 

are not meaningful, as under household conditions orange peel will not be consumed as edible portion per 

se. Under industrial juice processing conditions the fruits are processed unpeeled; this process was not

simulated in the present study. No concentration in wet pomace (possible feed item) was observed. 
- 163 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.7.2.2.2 Apple sauce and juice 

Reference: Determination of the residues of BYI 08330 in/on apple fruit and the 

processed fractions (fruit washed, washings, strain rest, raw sauce, sauce, 

raw juice, juice, pomace dried) after spraying of BYI 08330 (100 OD) in the 

field in Germany and United Kingdom 

Author(s), year: Schoening R., Helfrich P.; 2005, amended 12.01.2006 

Report/Doc. number: RA-3135/04, including trials no. R 2004 0795/5, R 2004 0797/1 

M-262624-02-1 

Guideline(s): EU Council Directive 91/414/EEC of July15, 1991, 

Annex II, part A, section 6 and Annex III, part A, section 8: Residues in or on 

treated products, food and feed 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

Reference: Determination of the residues of BYI 08330 in/on apple fruit and the 

processed fractions (fruit washed, washings, strain rest, raw sauce, sauce, 

raw juice, juice, pomace dried) after spraying of BYI 08330 (100 OD) in the 

field in Italy and Spain 

Author(s), year: Schoening R., Helfrich P.; 2006 

Report/Doc. number: RA-3137/04, including trials no. R 2004 0805/6, R 2004 0807/2 

M-264335-01-1 

Guideline(s): EU Council Directive 91/414/EEC of July15, 1991, 

Annex II, part A, section 6 and Annex III, part A, section 8: Residues in or on 

treated products, food and feed 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of the presented studies was to determine the transfer of BYI 08330 and its metabolites 

(BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy and BYI08330-enol-Glc) from apple fruits 

into processed fractions fruit, washed; washings (washing water); strain rest (pomace, wet); raw sauce (raw 

stewed fruit); sauce; raw juice; juice; pomace, dried. 

Material and methods:

Apple fruit samples from four field trials that were performed in Germany, United Kingdom, Italy and Spain as 

part of study RA-2135/04 and study RA-2137/04 were processed. For each process, washing, sauce and 

juice production, 4 representative samples of apple fruits from each those 4 supervised residue trials were 

used. Information about the treated plots is given in Table B.7.7.2.2.2-2. 

Table B.7.7.2.2.2-1: Application Data Summary in/on Apples in Northern and Southern Europe. 

Country Trial No. Number Formulation Kg a.s./ha 

Kg a.s./ha x m 

*) 

Growth stage 

BBCH 

Germany 

R 2004 0795/5 

2 OD 100 0.144 0.072 76-77 

United Kingdom 

R 2004 0797/1 

2 OD 100 0.137 0.072 85 

Italy 

R 2004 0805/6 

2 OD 100 0.216 0.072 79-81 
- 164 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Country Trial No. Number Formulation Kg a.s./ha 

Kg a.s./ha x m 

*) 

Growth stage 

BBCH 

Spain 

R 2004 0807/2 

2 OD 100 0.216 0.072 77-81 

*) Rate per m height of leafy surface 

Preparation of processed fractions:

The apples were processed into washed fruit, washing water (washings), strain rest (pomace wet), raw 

sauce (raw stewed fruit), sauce, raw juice, juice and pomace dried simulating household and industrial

procedures (see Table B.7.7.2.2.2-2). The washing simulated household processing, whereas the apple 

sauce and juice processing simulated the industrial practice at a laboratory scale. 

Table B.7.7.2.2.2-2: Preparation of apple (RAC) to processed fractions: 

Processing of Apple Fruit into 

Washed Fruit and Washing Water 

Processing of Apple Fruit into 

Strain rest (pomace wet), Raw 

Stewed Fruit 

and Wet Pomace 

Processing of Apple Fruit into 

Pomace Dried, Raw Juice and 

Juice 

Damaged apples were sorted out. Stalks and leaves were removed. Then the apple fruits were washed for 1 to 2 min. in 

lukewarm standing water (ratio water/fruits = 2/1 (w/w)) by moving them around slowly. After washing, the apples were 

let to drain in a sieve. 

The laboratory sample of fruit, 

washed was prepared by cutting the 

apples in four parts and filling them 

into a plastic bag. The laboratory 

sample of washing water was 

prepared by filling a portion of the 

washing water in polystyrene boxes. 

The washed fruits were cut in four or 

eight pieces using a knife. For 

blanching, the apple pieces were 

heated to 98 – 100°C; the blanching 

time depends on the degree of 

ripeness. After the blanching process 

was finished, the apple pulp was 

passed through a strainer in order to 

separate raw stewed fruit and wet 

pomace (strain rest). 

The remaining raw stewed fruit was 

weighed, mixed up with sugar (w 

(sugar) = 16.5 %) and filled into 1/1 

preserving cans. The preserving cans 

were pasteurised in an autoclave. 

After pasteurisation, the preserving 

cans were emptied in a larger vessel, 

mixed thoroughly and weighed. 

The washed apples were crushed into 

mash in a cutter. The obtained mash 

was pressed in a high-pressure press 

into raw juice and wet pomace. 

The wet pomace was dried in a fanassisted oven at about 100°C until the 

water content was nearly 10 %. 

The remaining raw juice was 

enzymated by heating the juice in a 

cooking pan for about 0.5 to 2 

minutes at 80 – 90°C. After cooling 

down to 45 – 50°C, pectolytic 

enzymes were added and the juice 

was left to stand for one hour at room 

temperature. The juice was stored for 

approx. 20 hours (overnight) at 4°C. 

Afterwards, the juice was fined 

coarsely by lifting up it by a tube and 

centrifugation of the lees. The Brixvalues of the filtrate and the retentate 

were determined. The coarsely fined 

juice was filtrated in a laboratory ultrafiltration set-up into the clear juice. 

Thereupon, the filtrated juice was 

pasteurised in a plate heatexchanger. After pasteurisation, the 

juice was collected in fractions. Only 

the fractions that had the same Brixvalue as the filtrate were collected in a 

bigger container and constituted the 

sample pasteurised juice. 

Residues of BYI 08330 and its metabolites BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy 

and BYI08330-enol-Glc in/on apple (fruit) were determined by HPLC-ESI-MS/MS. 

The Limit of Quantitation (LOQ), defined as the lowest validated fortification level (calculated as BYI 08330 

equivalents), was 0.01 mg/kg (BYI 08330), 0.012 mg/kg (BYI08330-enol, BYI08330-ketohydroxy, BYI08330-

mono-hydroxy) and 0.008 mg/kg (BYI08330-enol-Glc) in/on apple (fruit). The LOQ for the total residue of BYI 

08330 (sum of single analyte residues, each calculated as BYI 08330 equivalents) was calculated as 0.054 

mg/kg in/on apple (fruit). 
- 165 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Recovery results are summarized in Table B.7.7.2.2.2-3. 

Table B.7.7.2.2.2-3: Recovery results (concurrent recoveries) for BYI 08330 and its metabolites in 

apple fruit and processed commodities (Report No.: 3135/04, amended, including trials No. R 2004 

0795/5 and R 2004 0797/1; Report No.: 3137/04 including trials No. R 2004 0805/6 and R 2004 0807/2) 

Sample 

Material Apple fruit 1) Strain rest 2) Apple sauce 3)

Analyte Forti-fication 

levels *) 

Mean Recovery 

[%±RDS] 

Forti-fication 

levels 

Mean Recovery 

[%±RDS] 

Forti-fication 

levels 

Mean Recovery 

[%±RDS] 

BYI 08330 0.01 

1.0 

97 ± 8.1 

(n=27) 

0.01 

1.0 

102 ± 8.1 

(n=6) 

0.01 

1.0 

94 ± 11.6 

(n=6) 

BYI08330-enol 0.01 

1.0 

92 ± 7.0 

(n=27) 

0.01 

1.0 

98 ± 3.7 

(n=6) 

0.01 

1.0 

90 ± 7.8 

(n=6) 

BYI08330-

ketohydroxy 

0.01 

1.0 

97 ± 7.6 

(n=27) 

0.01 

1.0 

103 ± 6.9 

(n=6) 

0.01 

1.0 

97 ± 10.9 

(n=6) 

BYI08330-monohydroxy 

0.01 

1.0 

92 ± 7.2 

(n=27) 

0.01 

1.0 

98 ± 3.6 

(n=6) 

0.01 

1.0 

93 ± 6.4 

(n=6) 

BYI08330-enol-Glc 0.01 

1.0 

96 ± 8.3 

(n=27) 

0.01 

1.0 

107 ± 8.6 

(n=6) 

0.01 

1.0 

100 ± 7.7 

(n=6) 

1) Fruit covers fruit, washed; raw juice; juice and washings. 

2) Strain rest covers pomace, dried. 

3) Sauce covers raw sauce. 

*) levels refer to fortification with individual analytes (not calculated as BYI 08330 equivalents). 

The mean of the recoveries were for all matrices and for all fortification levels, within the acceptable range of 

70 – 110 %. 

Findings: 

The total residue of BYI08330 in apple fruit was between <0.054 (LOQ) and 0.2 mg/kg. In apple sauce, the 

total residue ranged between <0.054 and 0.13 mg/kg and was between <0.054 and 0.078 mg/kg in apple 

juice. Average factors of 0.6 and 0.8 were calculated for the transfer of the total residue of BYI08330 from 

apple fruit into apple juice and apple sauce. The residues results are summarised in Table B.7.7.2.2.2-4. 

Transfer factors are given in Table B.7.7.2.2.2-5. 

Table B.7.7.2.2.2-4: Residues of BYI 08330 in apple fruit and in processed commodities 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Germany 

R 2004 

0795/5 

fruit 

fruit, washed 

washings 

APPLE SAUCE:

strain rest 

raw sauce 

sauce 

APPLE JUICE: 

raw juice 

juice 

pomace, dried 

21 0.01

0.02

<0.01

0.05

0.01

0.01

<0.01

<0.01

0.16 

0.012

0.012

<0.012

0.029

0.018

0.016

0.012

0.012

0.092 

0.012

0.016

<0.012

0.025

0.017

0.013

0.012

0.012

0.077 

0.012

0.012

<0.012

0.012

0.012

0.012

0.012

0.012

0.013 

<0.008

0.008

<0.008

0.008

0.008

<0.008

0.008

0.008

0.008 

<0.054

0.064

<0.054

0.13

0.066

<0.054

<0.054

<0.054

0.35
- 166 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

United 

Kingdom 

R 2004 

0797/1 

fruit 

fruit, washed 

washings 

APPLE SAUCE:

strain rest 

raw sauce 

sauce 

APPLE JUICE: 

raw juice 

juice 

pomace, dried 

21 0.04

0.02

<0.01

0.12

0.03

0.02

0.02

0.01

0.31 

0.034

0.020

<0.012

0.055

0.044

0.039

0.024

0.019

0.22 

0.021

0.012

<0.012

0.026

0.021

0.017

0.016

0.013

0.094 

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

0.012 

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008

0.008 

0.096

<0.054

<0.054

0.20

0.098

0.075

0.058

<0.054

0.65

Italy 

R 2004 

0808/6 

fruit 

fruit, washed 

washings 

APPLE SAUCE:

strain rest 

raw sauce 

sauce 

APPLE JUICE: 

raw juice 

juice 

pomace, dried 

21 0.04

0.02

<0.01

0.06

0.01

0.01

0.02

<0.01

0.12 

0.014

0.012

<0.012

0.041

0.021

0.022

0.012

<0.012

0.11 

0.012

0.012

<0.012

0.012

0.012

0.012

0.012

<0.012

0.042 

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

<0.012

0.012 

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008

<0.008 

0.063

<0.054

<0.054

0.11

<0.054

<0.054

<0.054

<0.054

0.28

Spain 

R 2004 

0807/2 

fruit 

fruit, washed 

washings 

APPLE SAUCE:

strain rest 

raw sauce 

sauce 

APPLE JUICE: 

raw juice 

juice 

pomace, dried 

21 0.10

0.06

0.02

0.27

0.06

0.04

0.03

0.01

0.41 

0.015

0.077

0.020

0.34

0.070

0.043

0.042

0.012

0.50 

0.041

0.032

0.012

0.057

0.038

0.032

0.027

0.024

0.20 

0.028

0.021

<0.012

0.025

0.024

0.020

0.022

0.023

0.089 

0.008

0.008

<0.008

0.008

0.008

<0.008

0.008

0.008

0.008 

0.20

0.20

<0.054

0.70

0.20

0.13

0.13

0.078

1.2

Based on the residue levels in the treated processing products transfer factors were calculated. The transfer 

factors for the processing products are calculated according to the following equation: 

Transfer Factor = Residue concentration in the processed product [mg/kg] / Residue concentration in the 

RAC [mg/kg] 

Transfer factors are calculated on a worst-case basis. For this purpose, residues < LOQ are set at the LOQ. 

Average transfer factors of 0.6 and 0.8 could be calculated for the transfer of the total residue of BYI08330 

from apple fruit into apple juice and apple sauce. The transfer factors are summarized in Table .8.1.2-5. No 

transfer factors could be calculated for some processed commodities from trial R 2004 0795/5, because the 

total residue of BYI08330 in fruit and in processed commodities was below the LOQ. 

Table B.7.7.2.2.2-5: Transfer factors for the total residue of BYI08330 into processed commodities 

related to apple fruit 

Sample Transfer Factors for Total Residue of BYI08330 

material R 2004 0795/5 R 2004 0797/1 R 2004 0805/6 R 2004 0807/2 mean 

Washing of Fruit washed 1.2 0.6 0.9 1.0 0.9 

apples washings Not calculated 0.6 0.9 0.3 0.6 

Apple sauce 

processing 

Strain rest 

(wet pomace) 

2.4 2.1 1.7 3.6 2.5 
- 167 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Sample Transfer Factors for Total Residue of BYI08330 

material R 2004 0795/5 R 2004 0797/1 R 2004 0805/6 R 2004 0807/2 mean 

Raw sauce 

(raw stewed 

fruit) 

1.2 1.0 0.9 1.0 1.0 

Sauce Not calculated 0.8 0.9 0.7 0.8 

Raw juice Not calculated 0.6 0.9 0.7 0.7 

Juice 

pasteurised 

Not calculated 0.6 0.9 0.4 0.6 

Apple juice 

processing 

Dried pomace 6.4 6.8 4.4 6.2 6.0 

Conclusion: 

As average transfer factors of 0.6 and 0.8 could be calculated for the transfer of the total residue of 

BYI08330 from apple fruit into apple juice and apple sauce, no concentration of BYI08330 is to be expected 

in these two commodities during processing. A mean factor of 2.5 was calculated for wet pomace, which is 

used for animal feed. Resulting from the individual data points of residue trials on apples the STMR (0.096 

mg/lg) using the processing factor of 2.5 leads to a residue of 0.24 mg/kg in apple pomace, which contributes 

to the dietary burden. 

B.7.7.2.2.3 Cherry Fruit Preserve 

Reference: Determination of the residues of BYI 08330 in/on sweet cherry fruit and the 

processed fractions (fruit washed, washings, fruit depitted, preserve) and 

sour cherry fruit and the processed fractions (fruit washed, washings, fruit 

de-pitted, preserve) after spraying of BYI 08330 (100 OD) in the field in 

Northern France and Germany 

Author(s), year: Schoening R., Helfrich P.; 2005 

Report/Doc. number: RA-3119/04, including trials no. R 2004 0718/1, R 2004 0720/3, R 2004 0721/1, R 

2004 0723/8 

M-263882-01-1 

Guideline(s): EU Council Directive 91/414/EEC of July15, 1991, 

Annex II, part A, section 6 and Annex III, part A, section 8: Residues in or on 

treated products, food and feed 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of the presented study was to determine the transfer of BYI 08330 and its metabolites 

BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy and BYI08330-enol-Glc from sweet cherry 

and sour cherry (fruit, raw agricultural commodity) into sweet cherry and sour cherry processed fractions 

(fruit, washed; fruit, pitted; preserve) and by-products obtained during sweet and sour cherry processing 

(washings). 

Material and methods:

Sweet and sour cherry samples from four field trials that were performed in Germany and Northern France in 

2004 as part of study RA-2119/04 with BYI 08330 (100 OD) were processed. Information about the treated

plots is given in Table B.7.7.2.2.3-1. 
- 168 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.2.2.3-1: Application Data Summary in/on Sweet and Sour Cherries in Northern Europe. 

Country Trial No. Number Formulation Kg a.s./ha 

Kg a.s./ha x m 

*) 

Growth stage 

BBCH 

Northern France 

R 2004 0718/1 

2 OD 100 0.144 0.072 73-75 

Germany 

R 2004 0720/3 

2 OD 100 0.180 0.072 76-78 

Northern France 

R 2004 0721/1 

2 OD 100 0.144 0.072 76-81 

Germany 

R 2004 0723/8 

2 OD 100 0.144 0.072 75 

*) Rate per m height of leafy surface 

Preparation of processed fractions:

The processing of washed fruit and pitted fruit simulated household practice (see Table B.7.7.2.2.3-2). The 

processing of preserve simulated the industrial practice at a laboratory scale. 

Table B.7.7.2.2.3-2: Preparation of cherry (RAC) to processed fractions: 

Processing of Fruit into Washed Fruit and Washing 

Water 

Processing of Cherry Fruit into Pitted Fruit and 

Preserve 

Stalks and damaged fruits were sorted out. The fruits were 

washed for approx. 2 min in lukewarm standing water

(ratio water/fruits = 2/1 (w/w)) by moving them around 

slowly. After washing, the fruits were let to drain in a sieve. 

Stalks and damaged fruits were sorted out. The fruits were 

washed for 1 to 2 min in lukewarm standing water (ratio 

water/fruits = 2/1 (w/w)) by moving them around slowly. 

After washing the fruits were let to drain in a sieve. The 

washed fruits were pitted by hand. 

The pitted fruits remaining for further processing were 

filled into 1/1 preserving cans and sugar solution (w 

(sugar) = 0.14) was added. The preserving cans were

pasteurised in an autoclave. After pasteurisation, the 

preserving cans were emptied in a larger vessel, mixed 

thoroughly and weighed. 

Residues of BYI 08330 and its metabolites BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy 

and BYI08330-enol-Glc were determined by HPLC-ESIMS/ MS according to method 00857 in/on sweet 

cherry and according to method 00857/E001 in/on sour cherry (raw agricultural commodity, processed 

commodities and processing by-products). 

The Limit of Quantitation (LOQ), defined as the lowest validated fortification level (calculated as BYI 08330 

equivalents), was 0.01 mg/kg (BYI 08330), 0.012 mg/kg (BYI08330- enol, BYI08330-ketohydroxy, BYI08330-

mono-hydroxy) and 0.008 mg/kg (BYI08330- enol-Glc) in/on sweet and sour cherry (raw agricultural 

commodity, processed commodities and processing by-products). The LOQ for the total residue of BYI 

08330 (sum of single analyte residues, each calculated as BYI 08330 equivalents) was calculated as 0.054 

mg/kg in/on sweet and sour cherry (raw agricultural commodity, processed commodities and processing byproducts). 

Recovery results are summarized in Table B.7.7.2.2.3-3. 

Table B.7.7.2.2.3-3: Recovery results (concurrent recoveries) for determination of BYI 08330 and its 

metabolites in cherry fruit and in processed commodities 

Sample 

Material Sweet Cherry Fruit Sweet Cherry Preserve Sour Cherry Fruit Sour Cherry Preserve 

Analyte Forti-fication 

levels *) 

Mean 

Recovery 

[%±RDS] 

Forti-fication 

levels 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

BYI 08330 0.01 

1.0 

92 ± 4.6 

(n=12) 

0.01 

1.0 

86 

(n=2) 

0.01 

1.0 

93 ± 5.6 

(n=12) 

0.01 

1.0 

93 

(n=2) 
- 169 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Sample 

Material Sweet Cherry Fruit Sweet Cherry Preserve Sour Cherry Fruit Sour Cherry Preserve 

Analyte Forti-fication 

levels *) 

Mean 

Recovery 

[%±RDS] 

Forti-fication 

levels 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

BYI08330-

enol 

0.01 

1.0 

91 ± 12.5 

(n=12) 

0.01 

1.0 

86 

(n=2) 

0.01 

1.0 

92 ± 13.1 

(n=12) 

0.01 

1.0 

97 

(n=2) 

BYI08330-

ketohydroxy 

0.01 

1.0 

94 ± 6.9 

(n=12) 

0.01 

1.0 

88 

(n=2) 

0.01 

1.0 

95 ± 6.5 

(n=12) 

0.01 

1.0 

93 

(n=2) 

BYI08330-

monohydroxy 

0.01 

1.0 

93 ± 5.3 

(n=12) 

0.01 

1.0 

88 

(n=2) 

0.01 

1.0 

94 ± 5.2 

(n=12) 

0.01 

1.0 

92 

(n=2) 

BYI08330-

enol-Glc 

0.01 

1.0 

93 ± 4.8 

(n=12) 

0.01 

1.0 

93 

(n=2) 

0.01 

1.0 

93 ± 4.6 

(n=12) 

0.01 

1.0 

92 

(n=2) 

*) levels refer to fortification with individual analytes (not calculated as BYI 08330 equivalents). 

The mean of the recoveries were for all matrices and for all fortification levels, within the acceptable range of 

70 – 110 %. 

Findings:

The total residue of BYI08330 in cherry fruit used for the processing studies was between 0.28 and 0.93 

mg/kg. In washed fruit the total residue ranged from 0.25 to 0.83 mg/kg and in preserve from 0.13 to 0.43 

mg/kg. An average factor of 0.5 was calculated for the transfer of the total residue of BYI08330 from cherry 

fruit into cherry preserve. The residues results determined in the different processed commodities are given 

in Table B.7.7.2.2.3-4. 

Table B.7.7.2.2.3-4: Residues of BYI 08330 in cherry fruit and in processed commodities 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Northern 

France 

R 2004 

0718/1 

Sweet 

Cherry 

fruit 

fruit, washed 

washings 

fruit, pitted 

preserve 

21 0.01

0.01

<0.01

0.01

0.01 

0.32

0.30

<0.012

0.29

0.19 

0.11

0.13

<0.012

0.077

0.044 

0.12

0.12

<0.012

0.12

0.068 

0.023

0.022

<0.008

0.020

0.012 

0.57

0.59

<0.054

0.51

0.33

Germany 

R 2004 

0720/3 

Sour 

Cherry 

fruit 

fruit, washed 

washings 

fruit, pitted 

preserve 

21 0.01

0.01

<0.01

0.01

0.01 

0.21

0.17

<0.012

0.20

0.087 

0.033

0.036

<0.012

0.029

0.013 

0.021

0.021

<0.012

0.029

0.012 

0.011

0.011

<0.008

0.015

0.008 

0.28

0.25

<0.054

0.28

0.13

Northern 

France 

R 2004 

0721/1 

Sweet 

Cherry 

fruit 

fruit, washed 

washings 

fruit, pitted 

preserve 

21 0.02

0.01

<0.01

0.01

0.01 

0.58

0.51

<0.012

0.43

0.28 

0.072

0.093

<0.012

0.050

0.032 

0.17

0.14

<0.012

0.11

0.068 

0.097

0.076

<0.008

0.058

0.034 

0.93

0.83

<0.054

0.65

0.43

Germany 

R 2004 

0723/8 

Sour 

Cherry 

fruit 

fruit, washed 

washings 

fruit, pitted 

preserve 

21 <0.01

<0.01

<0.01

<0.01

<0.01 

0.21

0.21

<0.012

0.18

0.10 

0.012

0.019

<0.012

0.012

0.012 

0.040

0.041

<0.012

0.037

0.019 

0.023

0.023

<0.008

0.018

0.009 

0.29

0.29

<0.054

0.25

0.14
- 170 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Based on the residue levels in the treated processing products transfer factors were calculated. The transfer 

factors for the processing products are calculated according to the following equation: 

Transfer Factor = Residue concentration in the processed product [mg/kg] / Residue concentration in the 

RAC [mg/kg] 

Transfer factors are calculated on a worst-case basis. For this purpose, residues < LOQ are set at the LOQ. 

Average transfer factors of 0.9 and 0.5 could be calculated for the transfer of the total residue of BYI08330 

from cherry fruit into pitted fruit and preserve. The transfer factors are summarized in Table B.7.7.2.2.3-5. 

Table B.7.7.2.2.3-5: Transfer factors for the total residue of BYI08330 into processed commodities 

related to cherry fruit 

Transfer Factors for Total Residue of BYI08330 Sample material 

R 2004 0718/1 R 2004 0720/3 R 2004 0721/1 R 2004 0723/8 mean 

Fruit washed 1.0 0.9 0.9 1.0 1.0 

Washing water 0.1 * 0.2 * 0.1 * 0.2 * 0.2 

Fruit, pitted 0.9 1.0 0.7 0.8 0.9 

Preserve 0.6 0.5 0.5 0.5 0.5 

* Residues < LOQ are set to LOQ. 

Conclusion: 

As average transfer factors of 0.9 and 0.5 could be calculated for the transfer of the total residue of 

BYI08330 from cherry fruit into pitted cherry fruit and cherry preserve, no concentration of BYI08330 is to be 

expected in these two commodities during processing. 

B.7.7.2.2.4 Raisins 

Reference: Determination of the residues of BYI 08330 in the processed fractions of 

grape, bunch of grapes for processing (raisin waste, washings, raisin) after 

spraying of BYI 08330 (150 OD) in the field in Spain and Italy 

Author(s), year: Ballesteros C., Eberhard R.; 2006, amended 21.08.2006 

Report/Doc. number: RA-3034/05, including trials no. R 2005 0157/9, R 2005 0158/7 

M-271371-02-1 

Guideline(s): EU Council Directive 91/414/EEC of July15, 1991, Annex II, part A, section 6 and 

Annex III, part A, section 8: Residues in or on treated products, food and feed 

GLP: Yes. 

Deviations: None. 

Validity: The mean of the concurrent recoveries were for all matrices and for all fortification 

levels, within the acceptable range of 70 – 110 %, except on grape raisin waste 

and grape raisin for BYI08330-enol-Glucoside, the recoveries were around 65 %, 

but with a low RSD these results were considered as valid. Consequently, all the 

results are regarded as valid. 

The purpose of the presented study was to determine the transfer of BYI 08330 and its metabolites 

BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy and BYI08330-enol-Glc from grape (bunch 

of grapes) into raisins and by-products obtained during processing (washing water and raisin waste). 

Material and methods:

The grape samples used for processing originated from two supervised field residue trials with grape in 

Spain and Italy. A treated and an untreated plot were used for each trial. Information about the treated plots 
- 171 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

is given in Table B.7.7.2.2.4-1. The samples of bunch of grape for processing were taken on day 7 after the 

last application. 

Table B.7.7.2.2.4-1: Application Data Summary in/on Grapes in Southern Europe. 

Country Trial No. Number Formulation Kg a.s./ha Kg a.s./hL 

Growth stage 

BBCH 

Spain 

R 2005 0157/9 

2 OD 150 0.0960 0.01200 83 - 85 

Italy 

R 2005 0158/7 

2 OD 150 0.0960 0.00960 77 - 79 

Preparation of processed fractions:

The processing of bunch of grapes into raisins simulated the industrial practice at a laboratory scale. 

Bunches of grapes were de-stemmed (separation into stalks and berries with stems) before drying in order to 

accelerate the drying process. The berries were dried at a temperature of 60 to 65°C in a fan-assisted oven 

in order to lower the water content to 6 to 13%. 

To calculate the weight of raisin waste (= stalks + stems) after drying, the stalks (A) were also dried in the 

oven under the same conditions as the berries. After drying, the stems (B) were removed from the berries. 

The stems and the dried stalks were combined, yielding the sample raisin waste (A + B). 

The dried berries were washed in lukewarm standing water, during the washing step, the dried berries 

absorbed water. The water content of the raisins after washing (typically between 13 and 24%) was 29.4% 

(R 2005 0157/9 C), 21.4% (R 2005 0157/9 TA), 24.6% (R 2005 0157/9 TB), 20.3% (R 2005 0158/7 TA) and 

20.6% (R 2005 0158/7 TB). The raisins and the washing water were sampled. 

Residues of BYI08330 and its metabolites were determined by HPLC-ESI-MS/MS according to method 

00857. The quantification was performed using a stable-labelled internal standard for each reference item. 

The Limit of Quantitation (LOQ), defined as the lowest validated fortification level (calculated as BYI 08330 

equivalents), was 0.01 mg/kg (BYI 08330), 0.012 mg/kg (BYI08330-enol, BYI08330-ketohydroxy, BYI08330-

mono-hydroxy) and 0.008 mg/kg (BYI08330-enol-Glc) in/on apple (fruit). The LOQ for the total residue of BYI 

08330 (sum of single analyte residues, each calculated as BYI 08330 equivalents) was calculated as 0.054 

mg/kg in/on grapes (fruit and processed fractions).

Storage period for samples: The processed samples were kept deep-frozen for 17 to 27 days prior to 

analysis (last extraction). The storage period of deep-frozen samples of bunch of grapes was 112 and 126 

days. 

Procedural recovery results are summarized in Table B.7.7.2.2.4-2. 

Table B.7.7.2.2.4-2: Recovery results (concurrent recoveries) for determination of BYI 08330 and its 

metabolites in grapes and in processed commodities 

Sample Material Grape raisin waste Grape washings Grape raisin 

Analyte Fortification 

levels*)

Mean Recovery 

[%±RDS] 

Fortification 

levels*)

Mean Recovery 

[%±RDS] 

Fortification 

levels*)

Mean 

Recovery 

[%±RDS] 

BYI 08330 0.01 

1.0 

94 ± 11.5 

(n=6) 

0.01 

1.0 

98 ± 14.1 

(n=6) 

0.01 

1.0 

97 ± 12.4 

(n=6) 

BYI08330-enol 0.01 

1.0 

90 ± 2.2 

(n=6) 

0.01 

1.0 

95 ± 5.2 

(n=6) 

0.01 

1.0 

96 ± 1.5 

(n=6) 

BYI08330-ketohydroxy 

0.01 

1.0 

90 ± 4.0 

(n=6) 

0.01 

1.0 

94 ± 8.1 

(n=6) 

0.01 

1.0 

93 ± 5.9 

(n=6) 

BYI08330-monohydroxy 

0.01 

1.0 

89 ± 2.3 

(n=6) 

0.01 

1.0 

96 ± 6.8 

(n=6) 

0.01 

1.0 

92 ± 4.9 

(n=6) 

BYI08330-enolGlc 

0.01 

1.0 

61 ± 7.4 

(n=6) 

0.01 

1.0 

95 ± 7.0 

(n=6) 

0.01 

1.0 

66 ± 5.2 

(n=6) 

*) levels refer to fortification with individual analytes (not calculated as BYI 08330 equivalents). 
- 172 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The mean of the recoveries were for all matrices and for all fortification levels, within the acceptable range of 

70 – 110 %; except on grape raisin waste and grape raisin for BYI08330-enol-Glucoside, the recoveries were 

around 65 %, but with a low RSD these results were considered as valid. Consequently, all the results are 

considered as valid. 

Findings:

The total residues of BYI08330 in bunch of grapes used for raisin productions were 0.16 and 0.45 mg/kg, 

respectively. In raisins, the total residue of BYI08330 ranged between 0.23 and 1.6 mg/kg. 

Residue results are given in Table B.7.7.2.2.4-3. 

Table B.7.7.2.2.4-3: Residues of BYI 08330 in grapes and in processed commodities 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Spain 

R 2005 

0157/9 

Bunch of 

grapes 

Sample TA*:

raisin waste 

washings 

raisin 

Sample TB:

raisin waste 

washings 

raisin 

7 0.09 

0.07 

<0.01 

<0.01 

0.14 

<0.01 

0.02 

0.03 

0.24 

<0.012 

0.17 

0.26 

<0.012 

0.17 

0.02 

0.087 

<0.012 

0.020 

0.12 

<0.012 

0.021 

<0.01 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.02 

0.052 

<0.008 

0.032 

0.063 

<0.008 

0.045 

0.16 

0.48 

<0.054 

0.23 

0.63 

<0.054 

0.25 

Italy 

R 2005 

0158/7 

Bunch of 

grapes 

Sample TA:

raisin waste 

washings 

raisin 

Sample TB:

raisin waste 

washings 

raisin 

7 0.11 

0.44 

0.02 

0.25 

0.54 

0.02 

0.21 

0.22 

0.57 

0.029 

0.86 

0.39 

0.016 

0.69 

0.028 

0.21 

<0.012 

0.11 

0.27 

<0.012 

0.085 

0.014 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.082 

0.18 

0.032 

0.34 

0.17 

0.016 

0.33 

0.45 

1.5 

0.089 

1.6 

1.5 

0.062 

1.4 

* TA and TB are two different samples from one trial.

Based on the residue levels in the treated processing products transfer factors were calculated. The transfer 

factors for the processing products are calculated according to the following equation: 

Transfer Factor = Residue concentration in the processed product [mg/kg] / Residue concentration in the 

RAC [mg/kg] 

Transfer factors are calculated on a worst-case basis. For this purpose, residues < LOQ are set at the LOQ. 

An average factor of 2.7 was calculated for the transfer of total residue of BYI08330 from bunch of grapes 

into raisins. The transfer factors for the total residue of BYI08330 in raisins and processed by-products are 

summarised in Table B.7.7.2.2.4-4. 
- 173 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.2.2.4-4: Transfer factors for the total residue of BYI08330 into processed commodities 

related to bunch of grapes: 

Transfer Factors for Total Residue of BYI08330 

Sample material R 2005 0157/9 

TA 

R 2005 0157/9 

TB 

R 2005 0158/7 

TA 

R 2005 0158/7 

TB mean 

Raisin waste 3.2 4.1 3.6 3.3 3.6 

Washings 0.3 0.3 0.2 0.1 0.2 

raisin 1.7 1.8 4.0 3.3 2.7 

Conclusion: 

Concentration is to be expected during processing of grapes to raisins, as an average transfer factor of 2.7 

could be calculated for the transfer of the total residue of BYI08330 from bunch of grapes into raisin. 

B.7.7.2.2.5 Wine 

Reference: Determination of the residues of BYI 08330 in/on grape (bunch of grapes) 

and processed fractions (pomace grape, must, wine) after spraying of BYI 

08330 (100 OD) in the field in Germany 

Author(s), year: Schöning R., Wolters, A; 2006 

Report/Doc. number: RA-3048/04, including trials no. R 2004 0192/2, R 2004 0193/0 

M-264725-01-1 

Guideline(s): EU Council Directive 91/414/EEC of July15, 1991, Annex II, part A, section 6 and 

Annex III, part A, section 8: Residues in or on treated products, food and feed 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

Reference: Determination of the residues of BYI 08330 in/on grape bunch of grapes and 

the processed fractions (pomace grape, must, wine) after spraying of BYI 

08330 (100 OD) in the field in Italy 

Author(s), year: Schöning,R., Eberhard R.; 2006, amended 06.03.2006 

Report/Doc. number: RA-3049/04, including trials no. R 2004 0196/5, R 2004 0197/3 

M-263874-02-1 

Guideline(s): EU Council Directive 91/414/EEC of July15, 1991, Annex II, part A, section 6 and 

Annex III, part A, section 8: Residues in or on treated products, food and feed 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of the presented studies was to determine the transfer of BYI 08330 and its metabolites 

(BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy and BYI08330-enol-Glc) from grape 

(bunch of grapes) into processed commodities (pomace, grape; must; wine). 

Material and methods:

Grape samples from two field trials performed in Germany as part of study RA-2048/04 with BYI 08330 (100 

OD) and from two field trials performed in Italy as part of study RA-2049/04 with BYI 08330 (100 OD) were 

processed. Representative samples of the raw agricultural commodity and processed commodities were 

analysed for residues of BYI 08330 and its metabolites. 
- 174 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The samples of bunch of grape for processing were taken on day 7 after the last application. A treated and 

an untreated plot were used for each trial. Information about the treated plots is given in Tables B.7.8.1.5-1 

and B.7.7.2.2.5-2, respectively. 

Table B.7.7.2.2.5-1: Application Data Summary in/on Grapes in Northern Europe. 

Country Trial No. Number Formulation Kg a.s./ha Kg a.s./hL 

Growth stage 

BBCH 

Germany 

R 2004 0192/2 

red grape variety: 

Portugieser 

2 OD 100 0.0720 0.00900 83 - 89 

Germany 

R 2004 0193/0 

white grape 

variety: Mueller 

Thurgau 

2 OD 100 0.0720 0.00900 85 

Preparation of processed fractions from the Northern European trials:

The fresh bunch of grapes samples were weighed and subsequently crushed in a grape crusher. The mash 

obtained was pressed in a cloth press, while the pressure was increased step by step from 0.2 to 2.0 bar. 

After pressing, the pomace was sampled and stored deep-frozen. The must was filled into vessels and 0.1 

g/L of potassium hyposulfite was added. To prevent a later protein haze in the wine, 1 g/L of the fining agent 

bentonite was added to the wine. After clarifying the must was decanted from the lees. 

A sample of the must was taken and stored deep-frozen. The fermentation was started by the addition of 20 

g / 100 L pure-culture yeast to the must. During the fermentation the loss of weight due to the conversion of 

sugar into CO2 was monitored in trial R 2004 0192/2. After fermentation (approximately 1 month later), the 

first racking was effected. The yeast sediment was removed and after sulphating (125 mg/L) of the young 

wine the finishing of the wine was started. Approximately 3 months later the wine was filtered and deepfrozen. 

Storage period for samples: The storage period of deep-frozen samples ranged between 56 and 170 days. 

Table B.7.7.2.2.5-2: Application Data Summary in/on Grapes in Southern Europe. 

Country Trial No. Number Formulation Kg a.s./ha Kg a.s./hL 

Growth stage 

BBCH 

Italy 

R 2004 0196/5 

white grape 

variety: 

Chardonnay 

2 OD 100 0.0960 0.00640 81 - 75 

Italy 

R 2004 0197/3 

red grape variety: 

Lambrusco di 

Sorbara 

2 OD 100 0.0960 0.00640 83 
- 175 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Preparation of processed fractions from the Southern European trials:

Preparation of grape pomace, must and white wine: Preparation of grape pomace, must and red wine: 

The deep-frozen sample of bunch of grapes originating 

from trial R 2004 0196/5 was allowed to thaw at 2.5 °C. 

The partly thawn grape sample was weighed and 

subsequently crushed in a grape crusher. The mash 

obtained was pressed in a cloth press, while the pressure 

was increased step by step from 0.2 to 2.0 bar. After 

pressing, part of the pomace was sampled and stored

deep-frozen. 

The must was filled into vessels and 0.1 g/L of potassium 

hyposulfite was added. To prevent a later protein haze in 

the wine, 1 g/L of the fining agent bentonite was added to 

the must. After clarifying, the must was decanted from the 

lees. A sample of the must was taken and stored deepfrozen. 

The fermentation was started by the addition of of 

pureculture yeast to the must. During fermentation, the 

loss of weight due to the conversion of sugar into CO2 was 

monitored. After fermentation, the first racking was

performed. The yeast sediment was removed and after

sulphiting of the young wine the finishing of the wine was 

started. Approximately 2 months later, 2nd racking was 

done; the wine was filtered and deep-frozen. 

The grapes originating from trial R 2004 0197/3 were 

allowed to thaw at 2.5 °C. The partly thawn grape sample 

was weighed and subsequently crushed and de-stemmed

in a grape crusher. 

A mash heating was performed by heating up the obtained 

mash with steam to a temperature of T = 78 °C for 3 min 

while stirring. The mash was allowed to cool down. The 

mash was pressed in a cloth press, while increasing the 

pressure step by step from 0.2 to 2.0 bar. The laboratory 

sample of grape pomace was prepared by filling a portion 

of the grape pomace in polystyrene boxes. 

The must was filled into vessels and a hyposulfite solution

was added. To prevent a later protein haze in the wine, 1 

g/L of the fining agent bentonite was added to the wine. 

The must was allowed to clarify. After clarifying overnight, 

the must was decanted from the lees. The laboratory

sample of must was prepared by filling a portion of the 

freshly decanted must in polystyrene boxes. The density of 

the obtained must was determined. The density of the 

must amounted to an Oechsle value of 67; therefore no 

sugar was added prior to fermentation. 

The fermentation was started by addition of pure-culture 

yeast to the must. During fermentation, the loss of weight 

due to the conversion of sugar into CO2 was monitored. 

The first racking was done 19 days after start of 

fermentation. After removal of the yeast sediment, 

potassium hyposulfite was added to the young wine and 

the finishing of the wine was started. Second racking was 

done about 2 months later. The wine was filtered and the 

laboratory sample of wine was prepared by filling a portion 

of the wine in polystyrene boxes directly after filtration. The 

laboratory samples were stored deep-frozen at -18 °C or 

below. 

Comment RMS: The reported procedure is not 

representative for vinification of red wine, as the

fermentation of red grapes takes place while the must is 

still on the mash (“Fermentation on skins”) 

Storage period for samples: The processed samples were kept deep-frozen for 19 or 20 days (wine) and 96 

to 98 days (pomace, grape; must) prior to analysis (last extraction). The storage period of deep-frozen 

samples of bunch of grapes was 192 or 222 days. 

Residues of BYI08330 and its metabolites were determined by HPLC-ESI-MS/MS according to method 

00857. The quantification was performed using a stable-labelled internal standard for each reference item. 

The Limit of Quantitation (LOQ), defined as the lowest validated fortification level (calculated as BYI 08330 

equivalents), was 0.01 mg/kg (BYI 08330), 0.012 mg/kg (BYI08330-enol, BYI08330-ketohydroxy, BYI08330-

mono-hydroxy) and 0.008 mg/kg (BYI08330-enol-Glc) in/on apple (fruit). The LOQ for the total residue of 

BYI 08330 (sum of single analyte residues, each calculated as BYI 08330 equivalents) was calculated as

0.054 mg/kg in/on grapes (fruit and processed fractions). 

Procedural recovery results are summarized in Table B.7.7.2.2.5-3. 
- 176 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.2.2.5-3: Recovery results (concurrent recoveries) for determination of BYI 08330 and its 

metabolites in grapes and in processed commodities 

Sample 

Material Bunch of grapes Grape pomace Must Wine 

Analyte 

Fortification 

levels *) 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

BYI 08330 0.01 

1.0 

90 ± 9.6 

(n=29) 

0.01 

1.0 

92 ± 5.2 

(n=8) 

0.01 

1.0 

94 ± 6.2 

(n=10) 

0.01 

1.0 

94 ± 5.1 

(n=8) 

BYI08330-

enol 

0.01 

1.0 

93 ± 10.0 

(n=29) 

0.01 

1.0 

95 ± 5.0 

(n=8) 

0.01 

1.0 

96 ± 6.6 

(n=10) 

0.01 

1.0 

97 ± 2.1 

(n=8) 

BYI08330-

ketohydroxy 

0.01 

1.0 

94 ± 9.8 

(n=29) 

0.01 

1.0 

94 ± 5.3 

(n=8) 

0.01 

1.0 

95 ± 7.3 

(n=10) 

0.01 

1.0 

93 ± 5.5 

(n=8) 

BYI08330-

monohydroxy 

0.01 

1.0 

92 ± 9.0 

(n=29) 

0.01 

1.0 

91 ± 2.7 

(n=8) 

0.01 

1.0 

92 ± 4.4 

(n=10) 

0.01 

1.0 

94 ± 4.1 

(n=8) 

BYI08330-

enol-Glc 

0.01 

1.0 

94 ± 8.4 

(n=29) 

0.01 

1.0 

88 ± 8.0 

(n=8) 

0.01 

1.0 

92 ± 4.5 

(n=10) 

0.01 

1.0 

92 ± 2.0 

(n=8) 

*) levels refer to fortification with individual analytes (not calculated as BYI 08330 equivalents). 

The mean of the recoveries were for all matrices and for all fortification levels, within the acceptable range of 

70 – 110 %; 

Findings:

In bunch of grapes used for wine production the total residue of BYI08330 was between 0.21 and 0.54 

mg/kg. The total residue of BYI 08330 in wine was 0.12 – 0.24 mg/kg. Residue results are given in Table 

B.7.7.2.2.5-4. 

Table B.7.7.2.2.5-4: Residues of BYI 08330 in grapes and in processed commodities 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Germany

R 2004 

0192/2 

Bunch of grapes

Pomace 

Must 

Wine 

7 0.15 

0.25 

0.10 

0.01 

0.073 

0.17 

0.064 

0.13 

0.012 

0.012 

0.012 

0.012 

<0.012 

0.012 

<0.012 

<0.012 

0.024 

0.039 

0.023 

0.018 

0.25 

0.48 

0.20 

0.17 

Germany 

R 2004 

0193/0 

Bunch of grapes

Pomace 

Must 

Wine 

7 0.15 

0.21 

0.05 

0.06 

0.036 

0.092 

0.021 

0.11 

0.012 

0.021 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.011 

0.028 

0.008 

0.008 

0.21 

0.36 

0.091 

0.19 

Italy 

R 2004 

0196/5 

Bunch of grapes

Pomace 

Must 

Wine 

7 0.15 

0.25 

0.10 

0.03 

0.17 

0.32 

0.054 

0.090 

0.095 

0.24 

0.077 

0.065 

0.012 

0.020 

<0.012 

<0.012 

0.11 

0.12 

0.056 

0.048 

0.54 

0.95 

0.29 

0.24 

Italy 

R 2004 

0197/3 

Bunch of grapes

Pomace 

Must 

Wine 

7 0.20 

0.44 

0.11 

0.04 

0.045 

0.077 

0.034 

0.048 

0.045 

0.056 

0.031 

0.017 

<0.012 

<0.012 

<0.012 

<0.012 

0.026 

0.024 

0.020 

0.013 

0.32 

0.60 

0.20 

0.12 

Based on the residue levels in the treated processing products transfer factors were calculated. The transfer 

factors for the processing products are calculated according to the following equation: 

Transfer Factor = Residue concentration in the processed product [mg/kg] / Residue concentration in the 

RAC [mg/kg] 

Transfer factors are calculated on a worst-case basis. For this purpose, residues < LOQ are set at the LOQ. 
- 177 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

An average transfer factor of 0.6 could be calculated for the transfer of the total residue of BYI08330 from 

bunch of grapes into must and wine. The transfer factors for the total residue of BYI 08330 in wine and the 

processed by-products are summarised in Table B.7.7.2.2.5-5. 

Table B.7.7.2.2.5-5: Transfer factors for the total residue of BYI08330 into processed commodities 

related to bunch of grapes: 

Transfer Factors for Total Residue of BYI08330 Sample material 

R 2004 0192/2 R 2004 0193/0 R 2004 0196/5 R 2004 0197/3 mean 

Pomace, grape 0.9 1.7 1.8 1.9 1.8 

Must 0.8 0.4 0.5 0.6 0.6 

Wine 0.7 0.9 0.4 0.4 0.6 

Conclusion: 

As an average transfer factor of 0.6 could be calculated for the transfer of the total residue of BYI08330 from 

bunch of grapes into must and wine, no concentration of BYI08330 is to be expected in these two 

commodities during processing. 

B.7.7.2.2.6 Tomato juice, preserve and puree 

Reference: Determination of the residues of BYI 08330 in/on tomato fruit and the 

processed fractions (washings, fruit peeled, raw juice, juice, strain rest, 

preserve, puree, fruit washed, raw puree, peel washed, peeling water) after 

spraying of BYI 08330 (100 OD) in the greenhouse in Greece, Spain and Italy 

Author(s), year: Freitag, T., Helfrich, P.; 2006 

Report/Doc. number: RA-3140/04, including trials no. R 2004 0827/7, R 2004 0828/5, R 2004 0829/3, R 

2004 0830/7 

M-263490-01-1 

Guideline(s): EU Council Directive 91/414/EEC of July15, 1991, Annex II, part A, section 6 and 

Annex III, part A, section 8: Residues in or on treated products, food and feed 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of the presented study was to determine the transfer of BYI 08330 and its metabolites 

(BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy and BYI08330-enol-Glc) from tomato 

fruits into processed fractions after processing of tomato fruits to juice, preserve and puree. 

Material and methods:

Tomato samples from four supervised greenhouse residue trials performed in Greece, Spain and Italy with 

BYI 08330 (100 OD) were processed. A treated and an untreated plot were used for each trial. 

Representative samples of the raw agricultural commodity and processed commodities were analysed for 

residues of BYI 08330 and its metabolites. Information about the treated plots is given in Table B.7.7.2.2.6-1. 

Table B.7.7.2.2.6-1: Application Data Summary in/on Tomato in Greenhouse: 

Country Trial No. Number Formulation Kg a.s./ha 

Kg a.s./ha x m 

*) 

Growth stage 

BBCH 

Greece 

R 2004 0827/7 

4 OD 100 0.1080 - 0.1188 0.072 73-81 

Spain 

R 2004 0828/5 

4 OD 100 0.1152 0.072 81-85 

Spain 

R 2004 0829/3 

4 OD 100 0.1340 – 0.1440 0.072 84-87 
- 178 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Country Trial No. Number Formulation Kg a.s./ha 

Kg a.s./ha x m 

*) 

Growth stage 

BBCH 

Italy 

R 2004 0830/7 

4 OD 100 0.1044 – 0.1440 0.072 71 - 72 

*) Rate per m height of leafy surface 

Preparation of processed fractions:

The processing procedures simulated the industrial practice at a laboratory scale (see Table B.7.7.2.2.6-2). 

For the preparation of examination samples, the deep-frozen field sub-samples were shredded with dry ice in 

a cutter. 

Table B.7.7.2.2.6-2: Preparation of tomato (RAC) to processed fractions: 

Preparation of Washed Fruits, 

Washing water (Washings), Raw 

Juice and Juice 

Preparation of Peeled Tomatoes, 

Peeling Water, Peel and Preserves 

Preparation of Raw Puree, Puree 

and Wet Pomace 

The tomatoes were washed in lukewarm standing water. Then samples 

of the washing water (washings) and 

the washed tomato fruits were taken. 

The remaining washed tomatoes were 

cut with a knife into small pieces. The 

cut tomatoes were heated to prevent 

enzymatic reactions. 

After this blanching process, the 

tomato pulp was passed through a 

strainer to separate raw juice and wet 

pomace. Sodium chloride was added 

to the raw juice. Then samples of the 

raw juice were taken. 

One part of the remaining raw juice 

was used for the processing into 

preserves.

The rest of the remaining raw juice 

was pasteurised. After pasteurisation 

the juice was sampled. 

Portions of the washing water 

(washings), washed fruits, raw juice 

and juice were stored deep-frozen at -

18°C or below until preparation of the 

examination samples. 

The deep-frozen tomatoes were 

washed in luke-warm standing water. 

After a few minutes the peel could be 

taken off. Samples of peel, peeling 

water and peeled fruits were taken. 

To another part of the remaining 

peeled tomatoes, raw juice was 

added. Then the tomato preserves

were pasteurised. After 

pasteurisation, the tomato preserves 

were sampled. 

Portions of the peeling water, peel, 

peeled fruits and of the preserves 

were stored deep-frozen at -18°C or 

below until preparation of the 

examination samples 

The tomatoes were washed in lukewarm standing water. The washed 

tomatoes were cut with a knife into 

small pieces. 

The cut tomatoes were heated to 

prevent enzymatic. After this 

blanching process, the tomato pulp 

was passed through a strainer to 

separate raw juice and wet pomace. 

The wet pomace was sampled. 

After addition of sodium chloride, the 

raw juice was separated into raw 

puree and tomato liquid by 

centrifugation. The tomato raw puree

was sampled. A part of the remaining 

raw puree was filled into 1/1 

preserving cans and pasteurised. 

After pasteurisation the puree was 

sampled. 

Portions of pomace wet, raw puree 

and puree were stored deep-frozen at 

-18°C or below until preparation of the 

examination samples. 

Storage period for samples: The storage period of deep-frozen samples ranged between 14 and 298 days. 

Residues of BYI 08330 and its metabolites BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy 

and BYI08330-enol-Glc in/on tomato (fruit) and processed fractions were determined by HPLC-ESI-MS/MS 

according to method 00857. 

The Limit of Quantitation (LOQ), defined as the lowest validated fortification level (calculated as BYI 08330 

equivalents), was 0.01 mg/kg (BYI 08330), 0.012 mg/kg (BYI08330-enol, BYI08330-ketohydroxy, BYI08330-

mono-hydroxy) and 0.008 mg/kg (BYI08330-enol-Glc) in/on tomato (fruit) and processed fractions. The LOQ 

for the total residue of BYI 08330 (sum of single analyte residues, each calculated as BYI 08330 equivalents) 

was calculated as 0.054 mg/kg in/on tomato (fruit) and processed fractions 

Procedural recovery results are summarized in Table B.7.7.2.2.6-3. 
- 179 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.2.2.6-3: Recovery results (concurrent recoveries) for determination of BYI 08330 and its 

metabolites in tomato and in processed commodities 

Sample Material Fruit 1) Preserve 2) Juice 3)

Analyte Forti-fication 

levels*)

Mean Recovery 

[%±RDS] 

Forti-fication 

levels*)

Mean Recovery 

[%±RDS] 

Forti-fication 

levels*)

Mean Recovery 

[%±RDS] 

BYI 08330 0.01 

1.0 

2.0 

90 ± 7.8 

(n=30) 

0.01 

1.0 

89 ± 8.8 

(n=12) 

0.01 

1.0 

92 ± 9.8 

(n=12) 

BYI08330-enol 0.01 

1.0 

2.0 

93 ± 12.5 

(n=30) 

0.01 

1.0 

87 ± 10.6 

(n=12) 

0.01 

1.0 

91 ± 11.3 

(n=12) 

BYI08330-ketohydroxy 0.01 

1.0 

2.0 

93 ± 6.6 

(n=30) 

0.01 

1.0 

94 ± 7.2 

(n=12) 

0.01 

1.0 

99 ± 6.3 

(n=12) 

BYI08330-monohydroxy 0.01 

1.0 

2.0 

93 ± 7.1 

(n=30) 

0.01 

1.0 

93 ± 7.7 

(n=12) 

0.01 

1.0 

97 ± 9.2 

(n=12) 

BYI08330-enolGlc 0.01 

1.0 

2.0 

97 ± 7.4 

(n=30) 

0.01 

1.0 

94 ± 8.6 

(n=12) 

0.01 

1.0 

100 ± 10.3 

(n=12) 

*) levels refer to fortification with individual analytes (not calculated as BYI 08330 equivalents). 

1) sample material fruit covers sample materials fruit washed, fruit peeled, peel washed. 

2) sample material preserve covers sample materials strain rest (pomace wet), raw puree and puree 

3) sample material juice covers sample materials raw juice, washings (washing water) and peeling water

The mean of the recoveries were for all matrices and for all fortification levels, within the acceptable range of 

70 – 110 %; 

Findings:

The total residue of BYI08330 in tomato fruit was between 0.2 and 0.5 mg/kg. The total residue in juice 

ranged between 0.13 and 0.3 mg/kg, in preserve between 0.1 and 0.35 mg/kg, and in puree between 0.13 

and 0.59 mg/kg. 

The residue results are summarised in Table B.7.7.2.2.6-4. 

Table B.7.7.2.2.6-4: Residues of BYI 08330 in tomatoes and in processed commodities 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Greece 

R 2004 

0827/7 

Fruit 

washings 

fruit, peeled 

raw juice 

juice 

strain rest 

preserve 

puree 

fruit, washed 

raw puree 

peel, washed 

peeling water 

3 0.06 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

<0.01 

0.01 

<0.01 

0.04 

0.01 

0.39 

<0.012 

0.30 

0.29 

0.27 

0.62 

0.31 

0.55 

0.29 

0.57 

0.30 

0.066 

0.021 

<0.012 

0.012 

0.012 

0.012 

0.027 

0.012 

0.022 

0.014 

0.022 

0.032 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.031 

<0.008 

0.030 

0.022 

0.018 

0.025 

0.028 

0.019 

0.018 

0.022 

0.008 

0.008 

0.50 

<0.054 

0.34 

0.32 

0.30 

0.67 

0.35 

0.59 

0.33 

0.61 

0.38 

0.096 
- 180 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Spain 

R 2004 

0828/5 

Fruit 

washings 

fruit, peeled 

raw juice 

juice 

strain rest 

preserve 

puree 

fruit, washed 

raw puree 

peel, washed 

peeling water 

3 0.09 

<0.01 

<0.01 

0.02 

0.01 

0.10 

0.01 

0.01 

0.05 

0.04 

0.78 

0.02 

0.10 

<0.012 

0.058 

0.098 

0.10 

0.23 

0.072 

0.18 

0.090 

0.15 

0.17 

0.012 

0.012 

<0.012 

<0.012 

0.012 

0.012 

0.012 

<0.012 

0.012 

0.012 

0.012 

0.034 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.043 

<0.008 

0.028 

0.028 

0.022 

0.027 

0.021 

0.026 

0.030 

0.030 

0.021 

0.008 

0.25 

<0.054 

0.086 

0.16 

0.14 

0.36 

0.10 

0.23 

0.19 

0.23 

1.0 

<0.054 

Spain 

R 2004 

0829/3 

Fruit 

washings 

fruit, peeled 

raw juice 

juice 

strain rest 

preserve 

puree 

fruit, washed 

raw puree 

peel, washed 

peeling water 

3 0.15 

0.02 

<0.01 

0.01 

<0.01 

0.02 

<0.01 

<0.01 

0.04 

0.01 

0.18 

0.04 

0.11 

0.021 

0.050 

0.12 

0.11 

0.23 

0.075 

0.13 

0.091 

0.12 

0.044 

0.012 

0.012 

<0.012 

<0.012 

0.012 

0.012 

0.012 

<0.012 

0.012 

0.012 

0.012 

0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.052 

<0.008 

0.029 

0.033 

0.025 

0.029 

0.028 

0.023 

0.064 

0.026 

0.010 

0.008 

0.32 

<0.054 

0.079 

0.17 

0.15 

0.29 

0.10 

0.17 

0.21 

0.17 

0.24 

0.061 

Italy 

R 2004 

0830/7 

Fruit 

washings 

fruit, peeled 

raw juice 

juice 

strain rest 

preserve 

puree 

fruit, washed 

raw puree 

peel, washed 

peeling water 

3 0.07 

<0.01 

0.01 

0.01 

<0.01 

0.02 

<0.01 

<0.01 

0.02 

0.01 

0.22 

0.01 

0.093 

<0.012 

0.057 

0.096 

0.10 

0.20 

0.092 

0.10 

0.063 

0.14 

0.084 

0.012 

0.012 

<0.012 

<0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.012 

0.031 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.028 

<0.008 

0.023 

0.022 

0.018 

0.018 

0.021 

0.012 

0.018 

0.019 

0.008 

<0.008 

0.20 

<0.054 

0.090 

0.14 

0.13 

0.25 

0.13 

0.13 

0.11 

0.18 

0.34 

<0.054 

Based on the residue levels in the treated processing products transfer factors were calculated. The transfer 

factors for the processing products are calculated according to the following equation: 

Transfer Factor = Residue concentration in the processed product [mg/kg] / Residue concentration in the 

RAC [mg/kg] 

Transfer factors are calculated on a worst-case basis. For this purpose, residues < LOQ are set at the LOQ. 

Average transfer factors of 0.6, 0.5 and 0.9 could be calculated for the transfer of the total residue of 

BYI08330 from tomato fruit into juice, preserve and puree, respectively. The transfer factors for the total 

residue of BYI 08330 in tomato and the processed by-products are summarised in Table B.7.7.2.2.6-5. 
- 181 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.2.2.6-5: Transfer factors for the total residue of BYI08330 into processed commodities 

related to tomato fruit: 

Transfer Factors for Total Residue of BYI08330 Sample material 

R 2004 0827/7 R 2004 0828/5 R 2004 0829/3 R 2004 0830/7 mean 

Juice Production: 

fruit washed 

washings 

raw juice 

juice 

0.7 

0.1 *)

0.6 

0.6 

0.8 

0.2 *)

0.6 

0.6 

0.7 

0.2 *)

0.5 

0.5 

0.6 

0.3 *)

0.7 

0.7 

0.7 

0.2 

0.6 

0.6

Preserve Production: 

fruit peeled 

peel washed 

peeling water 

preseve 

0.7 

0.8 

0.2 

0.7 

0.3 

4.0 

0.2 *)

0.4 

0.2 

0.8 

0.2 

0.3 

0.5 

1.7 

0.3 *)

0.7 

0.4 

1.8 

0.2 

0.5

Puree Production

strain rest (wet pomace)

puree 

raw puree 

1.3 

1.2 

1.2 

1.4 

0.9 

0.9 

0.9 

0.5 

0.5 

1.3 

0.7 

0.9 

1.2 

0.8 

0.9

*) For calculation of the transfer factor the residue in the processed fraction was set at LOQ. 

Conclusion:

As the average transfer factors resulting from tomato processing into juice, preserve and puree were <1.0, 

no concentration of BYI08330 is to be expected in these commodities during processing. 

B.7.7.2.2.7 Cooked beans 

Reference: Determination of the residues of BYI 08330 in/on climbing French bean 

(beans with pod) and the processed fractions (washings, cooking water, 

bean cooked, bean washed) after spraying of BYI 08330 (100 OD) in the 

greenhouse in Italy, Germany and southern France 

Author(s), year: Schöning R., Billian P., Wolters, A.; 2006 

Report/Doc. number: RA-3042/04, including trials no. R 2004 0172/8, R 2004 0173/6, R 2004 0174/4, R 

2004 0175/2 

M-263683-01-1 

Guideline(s): EU Council Directive 91/414/EEC of July15, 1991, Annex II, part A, section 6 and 

Annex III, part A, section 8: Residues in or on treated products, food and feed 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of the presented study was to determine the transfer of BYI 08330 and its metabolites 

(BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy and BYI08330-enol-Glc) from Climbing 

French bean (bean with pod, raw agricultural commodity) into Climbing French bean processed commodities 

(bean, cooked; bean with pod, washed) and by-products obtained during Climbing French bean processing 

(washings; cooking water). 

Material and Method:

Climbing French Bean samples from four greenhouse trials that were performed in Italy, Germany and 

Southern France as part of study RA-2042/04 with BYI 08330 (100 OD) were processed. Representative 

samples of the raw agricultural commodity, processed commodities and processing by-products were 

analysed for residues of BYI 08330 and its metabolites. 

Information about the treated plots is given in Table B.7.7.2.2.7-1. 
- 182 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.2.2.7-1: Application Data Summary in/on French beans in Greenhouse: 

Country Trial No. Number Formulation Kg a.s./ha 

Kg a.s./ha x m 

*) 

Growth stage 

BBCH 

Italy 

R 2004 0172/8 

4 OD 100 0.0864 - 0.1440 0.072 51-71 

Italy 

R 2004 0173/6 

4 OD 100 0.1440 0.072 71-76 

Germany 

R 2004 0174/4 

4 OD 100 0.1440 0.072 69-78 

Southern France 

R 2004 0175/2 

4 OD 100 0.1260 0.072 65-79 

*) Rate per m height of leafy surface 

Climbing French bean samples (bean with pod) were taken from the treated and the control plots on day 14 

after the last application.The field samples from all trials were stored deep-frozen within 24 hours after 

sampling. 

Preparation of processed fractions:

Processing of the Climbing French bean samples into washed beans with pod, washing water, cooked beans

with pod and cooking water was performed. The washing and cooking of Climbing French beans was done 

using household practice (see Table B.7.7.2.2.7-2).

Table B.7.7.2.2.7-2: Preparation of Climbing French bean with pod (RAC) to processed fractions: 

Preparation of Washed Climbing Beans and Washing 

Water 

Preparation of Cooked Climbing Beans and Cooking 

Water 

The beans were washed in lukewarm standing water. 

After washing, the beans were let to drain in a sieve. A 

portion of the washed beans and of the washing water was 

stored deep-frozen at -18°C or below until preparation of 

the examination samples. 

Both ends of the remaining washed beans were removed, 

and the beans were cut in small pieces (approx. 3 – 6 cm). 

Subsequently, the washed and cut beans were cooked for 

about 15 – 20 min in salt water. 

After cooking, the beans were let to drain in a sieve. A 

portion of the cooked beans and of the cooking water was 

stored deep-frozen at-18°C or below until preparation of 

the examination samples. 

Residues of BYI 08330 and its metabolites BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy 

and BYI08330-enol-Glc in/on Climbing French bean (raw agricultural commodity, processed commodities 

and processing by-products) were determined by HPLC-ESI-MS/MS according to method 00857/E001. 

The Limit of Quantitation (LOQ), defined as the lowest validated fortification level (calculated as BYI 08330 

equivalents), was 0.01 mg/kg (BYI 08330), 0.012 mg/kg (BYI08330-enol, BYI08330-ketohydroxy, BYI08330-

mono-hydroxy) and 0.008 mg/kg (BYI08330-enol-Glc) in/on Climbing French bean (raw agricultural 

commodity, processed commodities and processing by-products). The LOQ for the total residue of BYI 

08330 (sum of single analyte residues, each calculated as BYI 08330 equivalents) was calculated as 

0.054 mg/kg in/on Climbing French bean. 

Procedural recovery results are summarized in Table B.7.7.2.2.7-3. 

Table B.7.7.2.2.7-3: Recovery results (concurrent recoveries) for determination of BYI 08330 and its 

metabolites in Climbing French bean and in processed commodities 

Sample material Bean with pod Washings 

Analyte Fortification levels*) Mean Recovery 

[%±RSD] Fortification levels*) Mean Recovery [%±RSD] 

BYI 08330 0.01 

2.0 

92 ± 5.4 

(n=19) 

0.01 

1.0 

92 ± 5.4 

(n=6) 

BYI08330-enol 0.01 

2.0 

88 ± 6.6 

(n=19) 

0.01 

1.0 

86 ± 12.5 

(n=6) 
- 183 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Sample material Bean with pod Washings 

Analyte Fortification levels*) Mean Recovery 

[%±RSD] Fortification levels*) Mean Recovery [%±RSD] 

BYI08330-keto-hydroxy 0.01 

2.0 

94 ± 4.7 

(n=19) 

0.01 

1.0 

94 ± 7.5 

(n=6) 

BYI08330-mono-hydroxy 0.01 

2.0 

94 ± 4.9 

(n=19) 

0.01 

1.0 

95 ± 6.0 

(n=6) 

BYI08330-enol-Glc 0.01 

2.0 

96 ± 9.8 

(n=19) 

0.01 

1.0 

99 ± 11.1 

(n=6) 

*) levels refer to fortification with individual analytes (not calculated as BYI 08330 equivalents). 

Recoveries for bean (cooked) and bean with pod (washed) were covered by the recoveries determined for 

bean with pod. Recoveries for cooking water were covered by the recoveries determined for washings. The 

mean of the recoveries were for all matrices and for all fortification levels, within the acceptable range of 70 – 

110 %; 

Findings:

The total residue of BYI08330 in beans with pod was between 0.11 and 0.57 mg/kg. The total residue in 

washed beans ranged between 0.076 and 0.47 mg/kg and in cooked beans between 0.07 and 0.31 mg/kg. 

The results are summarised in Table B.7.7.2.2.7-4. 

Table B.7.7.2.2.7-4: Residues of BYI 08330 in Climbing French bean and in processed commodities 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Italy 

R 2004 

0172/8 

Bean with pod 

washings 

cooking water 

bean cooked 

bean with pod 

washed 

14 0.06 

<0.01 

<0.01 

<0.01 

0.04 

0.12 

0.023 

0.061 

0.076 

0.12 

0.081 

<0.012 

0.012 

0.012 

0.046 

0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.030 

<0.008 

0.008 

0.010 

0.022 

0.31 

<0.054 

0.081 

0.097 

0.23 

Italy 

R 2004 

0173/6 

Bean with pod 

washings 

cooking water 

bean cooked 

bean with pod 

washed 

14 0.01 

<0.01 

<0.01 

<0.01 

0.01 

0.066 

<0.012 

0.029 

0.052 

0.019 

0.020 

<0.012 

0.012 

0.012 

0.038 

<0.012 

<0.012 

<0.012 

<0.012 

<0.012 

0.008 

<0.008 

0.008 

0.008 

0.008 

0.11 

<0.054 

<0.054 

0.071 

0.076 

Germany 

R 2004 

0174/4 

Bean with pod 

washings 

cooking water 

bean cooked 

bean with pod 

washed 

14 0.13 * 

0.01 

<0.01 

<0.01 

0.06 

0.29 * 

0.044 

0.12 

0.24 

0.24 

0.099 * 

0.012 

0.014 

0.025 

0.079 

0.012 * 

<0.012 

<0.012 

<0.012 

0.012 

0.035 * 

<0.008 

0.009 

0.015 

0.027 

0.57 * 

0.066 

0.14 

0.28 

0.42 

Southern 

France 

R 2004 

0175/2 

Bean with pod 

washings 

cooking water 

bean cooked 

bean with pod 

washed 

14 0.15 * 

0.01 

<0.01 

<0.01 

0.10 

0.26 * 

0.036 

0.15 

0.25 

0.23 

0.099 * 

0.012 

0.018 

0.029 

0.089 

0.012 * 

<0.012 

0.012 

0.012 

0.012 

0.043 * 

<0.008 

0.012 

0.020 

0.037 

0.57 * 

0.058 

0.19 

0.31 

0.47 

* Measurement in duplicate 

Based on the residue levels in the treated processing products transfer factors were calculated. The transfer 

factors for the processing products are calculated according to the following equation: 

Transfer Factor = Residue concentration in the processed product [mg/kg] / Residue concentration in the 

RAC [mg/kg] 
- 184 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Transfer factors are calculated on a worst-case basis. For this purpose, residues < LOQ are set at the LOQ. 

Average factors of 0.7 and 0.5 were calculated for the transfer of the total residue of BYI08330 from beans 

with pod into washed and cooked beans, respectively. 

Transfer factors are given in Table B.7.7.2.2.7-5. 

Table B.7.7.2.2.7-5: Transfer factors for the total residue of BYI08330 into processed commodities 

related to Climbing French bean with pod: 

Transfer Factors for Total Residue of BYI08330 Sample material 

R 2004 0172/8 R 2004 0173/6 R 2004 0174/4 R 2004 0175/2 mean 

Bean with pod, washed 0.7 0.7 0.7 0.8 0.7 

Washings 0.2 * 0.5 * 0.1 0.1 0.2 

Bean with pod, cooked 0.3 0.6 0.5 0.5 0.5 

Cooking water 0.3 0.5 * 0.2 0.3 0.3 

* For calculation of the transfer factors, residues below the LOQ were set at the LOQ. 

Conclusion:

As the average transfer factors resulting from Climbing French bean processing into bean, cooked; bean with 

pod, washed were <1.0, no concentration of BYI08330 is to be expected in these commodities during 

processing. 

B.7.7.2.2.8 Beer 

Reference: Determination of the residues of BYI 08330 in/on hop cone green for 

processing and the processed fractions (cone kiln-dried, beer, hops draff, 

brewer ́s yeast, brewer ́s malt)after spraying of BYI08330 (OG100) in the field 

in northern France and Germany 

Author(s), year: Schöning R., Billian P., Wolters, A.; 2006 

Report/Doc. number: RA-3036/04, including trials no. R 2004 0148/5, R 2004 0149/3, R 2004 0150/7, R 

2004 0151/5 

M-265067-01-1 

Guideline(s): EU Council Directive 91/414/EEC of July15, 1991, Annex II, part A, section 6 and 

Annex III, part A, section 8: Residues in or on treated products, food and feed 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

The purpose of the presented study was to determine the transfer of BYI 08330 and its metabolites 

(BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy and BYI08330-enol-Glc) from green hop 

cones via kiln-dried hop cones into hop processed commodities (beer) and by-products obtained during 

brewing processing (hops draff; brewer’s yeast; brewer’s malt). 

Material and Method:

Hop cone samples from four field trials that were performed in Northern France and Germany as part of 

study RA-2036/04 with BYI 08330 (100 OD) were processed. Representative samples of the raw agricultural 

commodity (hop, cone green), processed commodities and processing by-products were analysed for 

residues of BYI 08330 and its metabolites. 

Information about the treated plots is given in Table B.7.7.2.2.8-1. 
- 185 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.2.2.8-1: Application Data Summary in/on hops in Northern Europe: 

Country Trial No. Number Formulation Kg a.s./ha Kg a.s./hL 

Growth stage 

BBCH 

Northern France 

R 2004 0148/5 

2 OD 100 0.1750 0.00729 - 

0.00795 

65-75 

Germany 

R 2004 0149/3 

2 OD 100 0.1620 - 0.1750 0.00700 - 

0.00702 

68-75 

Germany 

R 2004 0150/7 

2 OD 100 0.1750 0.00700 71-77 

Northern France 

R 2004 0151/5 

2 OD 100 0.1750 0.00795 75-81 

All samples were stored in a freezer at -18°C or below until preparation of the examination samples. For the 

preparation of examination samples of raw agricultural commodity, processed commodities and processing

by-products, the deep-frozen samples were shredded with dry ice in a cutter. Representative parts of the 

shredded samples were stored at -18°C or below until analysis. 

Processing Procedures:

Hop samples (cone, green) for processing were taken from the treated plots on day 14 (trials R 2004 148/5, 

R 2004 0149/3 and R 2004 0150/7) and on day 15 (trial R 2004 0151/5) after the last application, 

respectively. Green cone samples were dried in a drying oven until approx. 10 % remaining moisture to get 

cone, kiln-dried samples for processing. The kiln-dried hop cones were processed simulating industrial

procedures (see Table B.7.7.2.2.8-2), whereby the degradation of the active ingredients was kept to a 

minimum (worst case situation). This was achieved by a minimum of processing steps. 

The process comprised the following fractions: 

- Hops draff (drip dried cones) 

- Brewing malt 

- Brewer ́s yeast 

- Beer 

The processing of hops to beer included the following procedures: 

- grinding of malt 

- mashing 

- lautering 

- boiling of wort and addition of hops 

- brewing malt separation 

- fermentation 

- cold storage and maturation 

- filtration and bottling 

Table B.7.7.2.2.8-2: Preparation of processed fractions: 

Grinding Brewing malt was ground by one passage through the malt-mill. The grist was not fractionated 

after grinding. An aliquot of the brewing malt was taken as a specimen. 

Mashing The grist was mashed into water which was heated to approx. 50°C in the mashing tub. While 

the grist was added and during the whole mashing procedure the mixture was stirred 

continuously. When all the grist was mashed in, the vessel was heated After the mashing 

procedure the mash was drained off into the heated lauter tub. 

Lautering The wort was separated from spent grain in the lauter tub by filtration. The remainder was 

washed with two portions of sparging water. The leachates were transferred into the kettle. 

Dried Cone 

Addition and 

Wort Boiling 

A calculated weight of dried cones was placed into a cotton bag. The cotton bag was closed 

and immersed into the wort which was subsequently heated up to boil and kept boiling. An 

aliquot of the hops (drip dry) was taken as a specimen. 
- 186 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Hot Trub 

Separation 

After completion of the boiling, the hot wort was drained into the whirlpool and the trub material 

was separated by applying the whirlpool technique: Using the tangential inlet, the wort was 

brought into rotation. The rotation caused the trub material to settle on the middle of the bottom 

of the vessel. The cleared wort was pumped through the cooling system into the cooled 

fermentation vessel. The complete amount of the trub (flocs) suspended in wort was weighed. 

The cleared wort was pumped into the fermentation vessel. The wort was cooled down by 

incubating the keg in a water bath. 

Fermentation Yeast suspended in water was added and the wort was aerated. The fermentation process was 

allowed to progress under darkened conditions in the closed fermentation vessel. Due to the 

carbon dioxide produced by the yeast during fermentation, a slight pressure was built up in the 

vessel. This procedure is called pressure fermentation and represents the most common 

fermentation procedure in the brewing industry. After 7 to 13 days the yeast had settled at the 

bottom of the vessel and the fermentation was complete. The green beer was drained off 

through the “bottom valve“and forced into a storage container by means of carbon dioxide. The 

yeast suspension remained in the keg and was removed later through the "side valve" and the 

entire amount was weighed and frozen. The yeast was separated after de-frosting of the 

suspension by means of centrifugation. 

The centrifuged yeast was taken as a specimen for residue analysis. 

Cold Storage The container with the green beer was placed into a chamber of the cooling box set to a 

temperature of approx. 0 to - 1°C. The green beer remained there for a period of 8 to 15 days. 

Filtration At the end of the brewing process, the beer was clarified by filtration in a filtration apparatus. 

The beer was added, mixed with the filter aids and the slurry was filtered using a horizontal 

candle filter. The first running was discarded. 

Bottling Immediately after filtering, the beer was filled into bottles through a spiral of stainless steel 

tubing. The beer was forced out of the reservoir using carbon dioxide from a cylinder. Finally, 

the bottles were capped with crown caps using a crowner. 

An aliquot of the beer was taken as a specimen. 

Storage period for samples: The storage period of deep-frozen samples ranged between 67 and 358 days. 

Residues of BYI 08330 and its metabolites BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy 

and BYI08330-enol-Glc in/on hop (cone, green; cone, kilndried, beer; hops draff; brewer’s yeast, brewer’s 

malt) were determined by HPLC-ESIMS/ MS according to method 00857. 

Cone, green; Cone, kiln-dried; Hops draff: 

The Limit of Quantitation (LOQ), defined as the lowest validated fortification level (calculated as BYI 08330 

equivalents), was 0.10 mg/kg (BYI 08330), 0.12 mg/kg (BYI08330-enol, BYI08330-ketohydroxy, BYI08330-

mono-hydroxy) and 0.08 mg/kg (BYI08330-enol-Glc) for hop (cone, green; cone, kiln-dried; hops draff). The 

LOQ for the total residue of BYI 08330 (sum of single analyte residues, each calculated as BYI 08330 

equivalents) was calculated as 0.54 mg/kg for hop (cone, green; cone, kilndried; hops draff). 

Beer; Brewer’s Yeast; Brewer’s Malt: 

The Limit of Quantitation (LOQ), defined as the lowest validated fortification level (calculated as BYI 08330 

equivalents), was 0.01 mg/kg (BYI 08330), 0.012 mg/kg (BYI08330-enol, BYI08330-ketohydroxy, BYI08330-

mono-hydroxy) and 0.008 mg/kg (BYI08330-enol-Glc) for hop (beer; brewer’s yeast, brewer’s malt). The 

LOQ for the total residue of BYI 08330 (sum of single analyte residues, each calculated as BYI 08330 

equivalents) was calculated as 0.054 mg/kg for hop (beer; brewer’s yeast; brewer’s malt). 

Procedural recovery results are summarized in Table B.7.7.2.2.8-3. 
- 187 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.7.2.2.8-3: Recovery results (concurrent recoveries) for determination of BYI 08330 and its 

metabolites in hop cones, green and in processed commodities 

Sample 

Material Hop (cone green) Hop (cone kilndried)) Beer Brewer’s yeast Brewer’s yeast 

Analyte 

Fortification 

levels *) 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels *) 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

Fortification 

levels 

Mean 

Recovery 

[%±RDS] 

BYI 

08330 

0.1 

5.0 

83 ±16.4

(n=8) 

0.1 

5.0 

86 

±12.4 

(n=11) 

0.01 

0.1 

5.0 

102 

±13.7 

(n=4) 

0.01 

0.1 

5.0 

93 ± 6.1

(n=7) 

0.01 

0.1 

5.0 

93 ± 4.7

(n=7) 

BYI08330

-enol 

0.1 

5.0 

78 ±11.0

(n=8) 

0.1 

5.0 

85 

±10.8 

(n=11) 

0.01 

0.1 

5.0 

105 ±5.5

(n=4) 

0.01 

0.1 

5.0 

95 ± 8.2

(n=7) 

0.01 

0.1 

5.0 

95 ± 3.4

(n=7) 

BYI08330

-ketohydroxy 

0.1 

5.0 

82 ± 9.2

(n=8) 

0.1 

5.0 

84 ± 8.8

(n=11) 

0.01 

0.1 

5.0 

101 ±9.9

(n=4) 

0.01 

0.1 

5.0 

98 ± 7.2

(n=7) 

0.01 

0.1 

5.0 

95 ± 5.9

(n=7) 

BYI08330

-monohydroxy 

0.1 

5.0 

78 ±10.8

(n=8) 

0.1 

5.0 

82 ± 7.9

(n=11) 

0.01 

0.1 

5.0 

99 ± 7.0

(n=4) 

0.01 

0.1 

5.0 

93 ±8.4

(n=7) 

0.01 

0.1 

5.0 

92 ± 4.4

(n=7) 

BYI08330

-enol-Glc 

0.1 

5.0 

78 ±10.4

(n=8) 

0.1 

5.0 

80 

±11.6 

(n=11) 

0.01 

0.1 

5.0 

98 ± 9.6

(n=4) 

0.01 

0.1 

5.0 

95 ± 5.7

(n=7) 

0.01 

0.1 

5.0 

91 ± 5.6

(n=7) 

*) levels refer to fortification with individual analytes (not calculated as BYI 08330 equivalents). 

The mean of the recoveries were for all matrices and for all fortification levels, within the acceptable range of 

70 – 110 %. 

Findings:

The total residue of BYI08330 in kiln-dried cones ranged between 1.5 and 4.2 mg/kg. The total residue in 

beer samples was below the LOQ of 0.055 mg/kg from each of four processing studies. The results are 

summarised in Table B.7.7.2.2.8-4. 

Table B.7.7.2.2.8-4: Residues of BYI 08330 in hop cones, green and in processed commodities 

Residues [mg/kg] 

Country / 

Trial No. 

Portion 

analysed 

PHI 

[days] BYI 08330 

BYI 

08330-

enol 

BYI 

08330-

ketohydroxy 

BYI 

08330-

monohydroxy 

BYI 

08330-

enol-Glc 

Total Res. 

of BYI 

08330 

calc. 

Northern 

France 

R 2004 

0148/5 

Cone green 

cone kiln dried 

beer 

hops draff 

brewer’s yeast 

brewer’s malt 

14 0.17 

0.63 

<0.01 

<0.1 

<0.01 

<0.01 

<0.12 

0.18 

<0.012 

<0.12 

0.017 

<0.012 

<0.12 

0.30 

<0.012 

<0.12 

0.012 

<0.012 

0.012 

<0.012 

<0.012 

<0.012 

0.012 

0.13 

0.41 

<0.008 

<0.08 

<0.008 

<0.008 

<0.54 

1.5 

<0.054 

<0.54 

<0.054 

<0.054 

Germany 

R 2004 

0149/3 

Cone green 

cone kiln dried 

beer 

hops draff 

brewer’s yeast 

14 0.27 

0.56 

<0.01 

<0.1 

<0.01 

<0.12 

0.25 

0.016 

<0.12 

0.076 

0.17 

0.39 

0.012 

<0.12 

0.014 

<0.12 

<0.12 

<0.012 

<0.12 

<0.012 

0.21 

0.50 

0.008 

<0.08 

0.008 

0.77 

1.7 

<0.054 

<0.54 

0.098 

Germany 

R 2004 

0150/7 

Cone green 

cone kiln dried 

beer 

hops draff 

brewer’s yeast 

14 0.19 

1.1 

<0.01 

<0.1 

<0.01 

<0.12 

0.75 

0.016 

<0.12 

0.062 

0.14 

0.75 

0.012 

<0.12 

0.012 

<0.12 

<0.12 

<0.012 

<0.12 

<0.012 

0.26 

1.3 

0.008 

<0.08 

0.008 

0.72 

3.9 

<0.054 

<0.54 

0.082 

Northern 

France 

R 2004 

0151/5 

Cone green 

cone kiln dried 

beer 

hops draff 

brewer’s yeast 

14 0.63 

2.6 

<0.01 

<0.1 

<0.01 

<0.12 

0.32 

0.023 

<0.12 

0.067 

0.19 

0.72 

0.012 

<0.12 

0.012 

<0.12 

<0.12 

<0.012 

<0.12 

<0.012 

0.14 

0.58 

0.008 

<0.08 

0.008 

1.1 

4.2 

<0.054 

<0.54 

0.087 
- 188 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Based on the residue levels in the treated processing products transfer factors were calculated. The transfer 

factors for the processing products are calculated according to the following equation: 

Transfer Factor = Residue concentration in the processed product [mg/kg] / Residue concentration in the 

RAC [mg/kg] 

For calculation of the transfer factors for the total residue in processed commodities total residues of below 

the LOQ, were set to the respective LOQ of 0.054 mg/kg (beer, brewer ́s yeast) or 0.54 mg/kg (hops draff). 

An average factor of below 0.02 was calculated for the transfer of the total residue of BYI08330 from dried 

hop cones into beer. The average factor for the transfer of the total residue into hops draff is below 0.24 and 

into brewer’s yeast is below 0.04. Transfer factors are given in Table B.7.7.2.2.8-5. 

Table B.7.7.2.2.8-5: Transfer factors for the total residue of BYI08330 into processed commodities 

related to kiln-dried cones 

Transfer Factors for Total Residue of BYI08330 Sample material 

R 2004 0148/5 R 2004 0149/3 R 2004 0150/7 R 2004 0151/5 mean 

Beer <0.04*. <0.03* <0.01* <0.01* <0.02 

Hops draff <0.36*. <0.32* <0.14* <0.13* <0.24 

Brewer’s yeast <0.04*. 0.06 0.02 0.02 <0.04 

* Residues in processed RAC were below LOQ. For calculation of the transfer factor the residues in the processed RAC were 

set at the LOQ of 0.054 mg/kg (brewer`s yeast, beer) or 0.54 mg/kg (hops draff). 

Conclusion:

As the average transfer factors resulting from hops (kiln dried cones) processing into beer, hops draff and 

brewer’s yeast were <1.0, no concentration of BYI08330 is to be expected in these commodities during 

processing. 

B.7.8 Livestock feeding studies (Annex IIA 6.4; Annex IIIA 8.4) 

Relevant for EU:

Estimation of the dietary burden for livestock animals:

Residues of Spirotetramat in animal feed might occur after treatment of head and leafy brassica, when kale 

or/and cabbage are fed to livestock. Residues might also be found in animal feed after treatment of citrus or 

pome fruit, when citrus dried pulp or apple wet pomace are fed to cattle. Intake calculations for chicken as 

well as for dairy and beef cattle were made taking into account the highest residue (see Tables B.7.9-1 to 

B.7.9-3): 

Table B.7.8-1: Intake calculations* for chicken: Maximum daily intake of 0.12 kg dry matter for 1.9 kg 

bodyweight: 

Actual

crop 

Max. 

percentage 

of actual 

crop in 

diet per 

day 

Intake of dry 

matter from 

actual crop 

[kg/animal/day] 

% of 

dry 

matter 

in 

actual 

crop 

Intake of fresh 

material 

[kg/animal/day] 

Residue 

in actual 

crop 

(fresh 

material)

[mg/kg] 

Residue intake 

[mg/animal/day] 

Residue 

intake 

[mg/kg

bw/day] 

Dietary 

burden

[mg/kg 

diet] 

kale 5 0.006 14 0.043 0.765 0.03279 0.0173 0.273 

* according to the Document 7031/VI/95/rev.4 (22.7.1996), Appendix G, Livestock Feeding Studies 
- 189 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Although the dietary burden exceeds the trigger of 0.1 mg a.s./kg feed, no residues of spirotetramat above 

0.01 mg/kg are expected in edible tissues or eggs with respect to the metabolism study in laying hens.

Therefore no feeding study in poultry was required.

Table B.7.8-2: Intake calculations* for beef cattle: Maximum daily intake of 15 kg dry matter 

for 350 kg bodyweight: 

Actual

crop 

Max. 

percentage 

of actual 

crop in 

diet per 

day 

Intake of dry 

matter from 

actual crop 

[kg/animal/day] 

% of 

dry 

matter 

in 

actual 

crop 

Intake of fresh 

material 

[kg/animal/day] 

Residue 

in actual 

crop 

(fresh 

material)

[mg/kg] 

Residue intake 

[mg/animal/day] 

Residue 

intake 

[mg/kg

bw/day] 

Dietary 

burden

[mg/kg 

diet] 

kale 35 5.25 14 37.5 0.765 28.69 0.082 1.91 

Apple 

wet 

pomace 

30 4.5 23 19.6 0.28 ** 5.48 0.016 0.37 

* according to the Document 7031/VI/95/rev.4 (22.7.1996), Appendix G, Livestock Feeding Studies 

** STMR (apples) of the Southern trials (0.113 mg/kg) x processing factor 2.5 

Table B.7.8-3: Intake calculations* for dairy cattle: Maximum daily intake of 20 kg dry matter for 

550 kg bodyweight: 

Actual

crop 

Max. 

percentage 

of actual 

crop in 

diet per 

day 

Intake of dry 

matter from 

actual crop 

[kg/animal/day] 

% of 

dry 

matter 

in 

actual 

crop 

Intake of fresh 

material 

[kg/animal/day] 

Residue 

in actual 

crop 

(fresh 

material)

[mg/kg] 

Residue intake 

[mg/animal/day] 

Residue 

intake 

[mg/kg

bw/day] 

Dietary 

burden

[mg/kg 

diet] 

kale 35 7 14 50.00 0.765 38.25 0.07 1.91 

Apple 

wet 

pomace 

10 2 23 8.7 0.28 2.43 0.004 0.12 

* according to the Document 7031/VI/95/rev.4 (22.7.1996), Appendix G, Livestock Feeding Studies 

** STMR (apples) of the Southern trials (0.113 mg/kg) x processing factor 2.5 

Kale and fruit pomace belong to the same group of feeding stuff (Group I, green forage). As it is pointed out 

in the tables above, the relevant contributor to the dietary burden is kale: 

In consequence of the dietary burden of 1.9 mg a.i./kg feed (dry weight basis), a feeding study in dairy cattle 

was designed to quantify the residues found in tissues and milk from dairy cows following oral administration 

of spirotetramat: 

Reference: BYI08330 150 OD - Magnitude of the residue lactating cows 

Author(s), year: Mackie, S. J. W. 

Report/Doc. number: Report No.: RAFNX014, 

Edition Number: M-276834-01-1 

Guideline(s): PMRA Directive 98-02; DACO 7.5.1/EPA OPPTS 860.1480 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 
- 190 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Material and methods:

Spirotetramat was administered via capsule to ten lactating Holstein dairy cows for 29 consecutive days. 

The target dose rates (based on feed dry weight) were 0 mg/kg feed/day (control), 3.0 mg/kg feed/day, 9.0 

mg/kg feed/day, or 30 mg/kg feed/day. Milk was collected twice daily during the dosing period. Milk samples 

from the 30-mg/kg dose group were analyzed for spirotetramat residue on study days 0, 1, 3, 7, 10, 14, 17, 

21, 24, 26, and 28. Additionally, a portion of the 26-day milk sample from the 30-mg/kg dose group was 

separated into milk fat (cream) and skim milk, and each was analyzed. On day 29, the animals were 

sacrificed and liver, kidney, composite muscle, and composite fat were collected for analysis. The tissue and 

milk samples in this study were analyzed within 19 days of collection; therefore, freezer storage stability 

studies on beef tissue and milk matrices were not required. 

The total spirotetramat residue in tissue and milk samples was quantitated by high-performance liquid 

chromatography-electrospray ionization/tandem mass spectrometry (LC-MS/MS) using isotopically labeled 

internal standards. The individual analyte residues of spirotetramat (parent) and the metabolites BYI 08330-

enol, and BYI 08330-enol-glucuronide (hereinafter referred to as BYI 08330-enol-GA), were summed to give 

a total spirotetramat residue in parent equivalents. The limit of quantitation (LOQ) was 0.005 mg/kg for each 

analyte in milk matrices and was 0.010 mg/kg for each analyte in the tissue matrices. 

Findings: 

Total spirotetramat residue in the milk samples from the 30-mg/kg feeding level were at or below the LOQ 

(0.005 mg/kg) in all cows throughout the study with the exception of a maximum residue of 0.006 mg/kg in 

one cow on study day 10. Residues of parent equivalents did not concentrate in samples of skim milk or milk 

fat separated from whole milk. 

Table B.7.8-4: Residue Data in Milk from Lactating Cattle Feeding Study with Spirotetramat 

Matrix/Collection Time Feeding Level (mg/kg) Total Residues (mg/kg) 

Milk/Day 0 30 < 0.005, < 0.005, < 0.005 

Milk/Day 1 30 < 0.005, < 0.005, < 0.005 

Milk/Day 3 30 < 0.005, < 0.005, < 0.005 

Milk/Day 7 30 < 0.005, < 0.005, < 0.005 

Milk/Day 10 30 0.005, 0.006, < 0.005 

Milk/Day 14 30 0.005, < 0.005, < 0.005 

Milk/Day 17 30 < 0.005, 0.005, < 0.005 

Milk/Day 21 30 0.005, 0.005, < 0.005 

Milk/Day 24 30 < 0.005, < 0.005, < 0.005 

Milk/Day 26 30 < 0.005, < 0.005, < 0.005 

Milk fat/Day 26 30 < 0.005, < 0.005, < 0.005 

Skim Milk/Day 26 30 < 0.005, < 0.005, < 0.005 

Milk/Day 28 30 < 0.005, < 0.005, < 0.005 

A low tissue burden was observed, with the highest residues found in kidney at the three dosing levels

(0.022 mg/kg, 0.075 mg/kg and 0.274 mg/kg, respectively). Despite the variability in the amount of total 

spirotetramat residues, there appeared to be a linear relationship with the dosing levels in kidney, fat and 

liver tissues at the three feeding levels. At the 3-mg/kg dosing level, average residues of spirotetramat 

equivalents were less than the LOQ (0.01 mg/kg) in fat, muscle and liver. The total average spirotetramat 

residues were <0.010 mg/kg (muscle), 0.012 mg/kg (fat), and 0.016 mg/kg (liver) at the 9-mg/kg dosing level. 

At the 30-mg/kg dosing level, the total average spirotetramat residues in muscle, fat and liver were 0.012 

mg/kg, 0.028 mg/kg, and 0.040 mg/kg, respectively. 
- 191 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.8-5: Summary of Residue Data from Lactating Cattle Feeding Study with Spirotetramat. 

Total Spirotetramat Residue Levels (ppm) 

Matrix Feeding Level 

(mg/kg) n Min. Max. Median Mean) Std. 

Dev. 

Milk 30 30 < 0.005 0.006 < 0.005 < 0.005 0.0006 

Milk fat 30 3 < 0.005 < 0.005 < 0.005 < 0.005 - 

Skim Milk 30 3 < 0.005 < 0.005 < 0.005 < 0.005 - 

Fat 3 3 < 0.010 < 0.010 < 0.010 < 0.010 - 

Fat 9 3 < 0.010 0.017 < 0.010 0.0123 0.004 

Fat 30 3 < 0.010 0.038 0.037 0.0283 0.016 

Kidney 3 3 0.021 0.025 0.021 0.022 0.002 

Kidney 9 3 0.051 0.103 0.070 0.075 0.026 

Kidney 30 3 0.184 0.437 0.200 0.274 0.142 

Muscle 3 3 < 0.010 < 0.010 < 0.010 < 0.010 - 

Muscle 9 3 < 0.010 < 0.010 < 0.010 < 0.010 - 

Muscle 30 3 < 0.010 0.016 0.011 0.012 0.003 

Liver 3 3 < 0.010 < 0.010 < 0.010 < 0.010 - 

Liver 9 3 0.013 0.018 0.016 0.016 0.003 

Liver 30 3 0.031 0.057 0.032 0.040 0.015 

Conclusion:

Relevant for PMRA (Canada) and US EPA : 

An adequate dairy cow feeding study has been submitted; this study is acceptable for determining MRL 

levels for livestock commodities. Based on the submitted data, MRLs expressed as spirotetramat and the 

metabolite BYI 08330-enol are required for some for livestock commodities. The potential for secondary 

transfer of spirotetramat residues of concern in meat, milk, and eggs exists because there are livestock 

feedstuffs associated with the proposed uses on apples, citrus, potatoes, and almonds.As none of the 

proposed target crops are considered as a commodity for poultry feed, data depicting residues in laying hens 

are not required. 

Expected secondary residues in meat and milk: 

The anticipated secondary residues in cattle matrices were estimated using transfer coefficient factors 

calculated from the maximum residues of spirotetramat and the metabolites observed at the 30-mg/kg dose 

level. The transfer coefficients (calculated as residue-level-to-feed ratios) are presented in the table below. 

The transfer coefficient for each matrix was then used to calculate the expected secondary residues by

multiplying the transfer coefficient by the calculated dietary burden. 

Table B.7.8-6: Residue-Level-to-Feed Ratios (Transfer Coefficients) in Dairy Cattle Milk and Tissues1 

Matrix Maximum Residue 

(ppm) Feeding Level, ppm Transfer Coefficient 

Milk 0.011 0.00037 

Fat 0.038 0.0013 

Muscle 0.016 0.00053 

Kidney 0.437 0.0146 

Liver 0.057 

30 

0.0019 

1

 Calculated from the maximum residues observed at the dose level closest to the RBDB divided by the dose level. 

Table B.7.8-7: Secondary Residues and Proposed MRLs: 

Matrix Dietary burden 

(ppm) 

Secondary Residues 

(ppm)1 Proposed MRL2

 (ppm) 

Milk 1.0 0.00037 0.01 

Fat 0.0016 0.02 

Kidney 

1.2 

0.018 0.02 
- 192 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Matrix Dietary burden 

(ppm) 

Secondary Residues 

(ppm)1 Proposed MRL2

 (ppm) 

Muscle 0.00064 0.02 

Liver 0.0023 0.02 

1

 Calculated from dietary burden x transfer coefficient from previous table. 

2

 LOQ-level MRL in order to harmonize with Canada. 

Relevant for EU : 

As the lowest dose rate of the feeding study was 3.0 mg a.i./kg dry feed instead of the expected highest 

intake of 1.9 mg a.i./kg dry feed, extrapolation is not possible. Therefore the following transfer factors for 

kidney were calculated, as only kidney showed residues above the LOQ in the lowest dose group: 

Table B.7.8-8: Transfer factors for kidney (concentration mg a.i./kg tissue / concentration mg a.i./kg

feed) 

Mean concentration 

found in kidney 

[mg/kg] 

Dose group 

[mg/kg] Transfer factor 

Calculated concentration 

in kidney for dietary 

burden of 

1.9 mg a.i./kg 

0.022 3 0.0073 0.014 mg/kg 

0.075 10 0.0075 0.014 mg/kg 

For these results a MRL of 0.02 mg/kg is proposed for bovine, sheep, goat and swine kidney. The LOQ of

0.01 mg/kg refers to BYI08330-enol only, calculated and expressed as BYI08330 parent equivalents; as for 

the time being no analytical monitoring method is available for parent spirotetramat. However, the parent 

compound was not found in any livestock tissue. 

Conclusion:

Basing on the results of the livestock feeding study, a MRL of 0.02 mg/kg is proposed for bovine, sheep, goat 

and swine kidney. For other edible tissues no MRL is required (LOQ at 0.01 mg/kg), also not for milk (LOQ at 

0.005 mg/kg). 

B.7.9 Residues in succeeding crops or rotational crops (Annex IIA 6.6; Annex IIIA 8.6) 

B.7.9.1 Confined rotational crop study using radiolabelled material 

Reference: Metabolism of [Azaspirodecenyl-3-14C]BYI 08330 in Confined Rotational 

Crops. Amendment No.1 of September 8, 2006. 

Author(s), year: Sur, R., Spiegel, K. (2006) 

Report/Doc. number: Report No.: MEF-05/288, 

Edition Number: M-269589-02-2 

Guideline(s): PMRA Directive 98-02; DACO 7.4.3/EPA OPPTS 860.1850 

GLP: Yes. 

Deviations: No. 

Validity: Yes. 

Material and methods:

The metabolism in rotational crops (spring wheat, Swiss chard and turnips) was investigated following spray 

application of [azaspirodecenyl-3-14C]-spirotetramat onto bare soil (day 0) at an application rate of 406 g 

a.i./ha (0.36 lbs. a.i./A). Crops were sown at day 30, day 135, and day 260. Representative immature and 

mature plant samples were analysed. 
- 193 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

The radioactivity in the extracts of all RACs obtained after conventional extraction was partitioned with 

dichloromethane (DCM), yielding a DCM phase and an aqueous phase. The phases were analysed (if the 

TRR exceeded 0.01 mg-equiv./kg) and the metabolites were quantified by high-performance liquid 

chromatography (HPLC). Identification of metabolites was performed by spectroscopic methods (HPLCmass spectrometry (MS)/MS, Fourier Transform (FT)-MS and 1H-nuclear-magnetic resonance (NMR) 

spectroscopy) or by HPLC and thin-layer chromatography (TLC) co-chromatography using authentic 

reference compounds. 

Since a major part of the residues were represented by conjugates, plant extracts were subjected to acid 

hydrolysis to cleave the conjugates and to simplify the metabolic profiles for analysis of residues. BYI 

08330-desmethyl-di-hydroxy, BYI 08330-ketohydroxy-alcohol, and BYI 08330-desmethyl-ketohydroxy were 

identified as the major constituents of the residues after hydrolysis. 

Findings: 

Sufficient data were available to support the storage intervals of the samples of all crops in this study. 

Storage stability data (reanalysis of extracts, re-extraction of stored samples over time) showed that

metabolite pattern, as well as the proportions of metabolites remained stable for at least 11 months when 

stored at ≤-18 °C. 

The total radioactive residues (TRRs) were highest in wheat straw of the 30-day rotation (0.998 mgequiv./kg) followed by wheat hay (0.384 mg-equiv./kg), turnip leaves (0.123 mg-equiv./kg), Swiss chard

(0.078 mg-equiv./kg), wheat grain (0.026 mg-equiv./kg), wheat forage (0.024 mg-equiv./kg), and turnip roots 

(0.021 mg-equiv./kg). A significant decline of the TRR from the 30-day to the 260-day rotation was observed 

in all raw agricultural commodities (RACs). In the 260-day rotation, only wheat hay and wheat straw showed 

residues above 0.01 mg-equiv./kg. The lowest residues were generally detected in the edible matrices of 

wheat grain and turnip roots, followed by Swiss chard. 

The majority of the radioactivity was extracted conventionally using acetonitrile (ACN)/water and ACN as 

solvents, except for samples of wheat grain. Approximately 83 to 97% of the TRR in the 30-day rotation 

crops, and 72 to 93% of the TRR in the 135-day rotation crops were extracted (grain excluded). In the 260-

day rotation, only wheat straw and wheat hay (contained TRRs >0.01 mg-equiv./kg) were extracted,

releasing 81% and 87% of the TRRs, respectively. For wheat grain (30-day and 135-day rotation) and wheat 

straw (30-day rotation), exhaustive extractions of post-extraction solids (PES 1) were conducted following the 

conventional extraction steps. The PES 1 of wheat grain containing 50-79% of the TRR was further treated 

with enzyme diastase and 45-67% of the TRR was released. The PES 1 of wheat straw containing 8% of 

the TRR was microwave extracted with ACN/water at 120°C; and, 4% of the TRR was further released. 

Summaries of characterization and identification of radioactive residues in the different plantback intervals 

are given in Tables B.7.9.1-1, B.7.9.1-2 and B.7.9.1-3. 
- 194 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.9.1-1: Summary of Characterization and Identification of Radioactive Residues in 30-day PBI Rotational Crop Matrices Following Application of Radiolabeled Spirotetramat at 406 g a.i./ha. 

 wheat forage wheat hay wheat straw wheat grain Swiss chard turnip leaves turnip roots 

TRR 0.024 mg- equiv./kg 0.384 mg- equiv./kg 0.998 mg- equiv./kg 0.026 mg- equiv./kg 0.078 mg- equiv./kg 0.123 mg- equiv./kg 0.021 mg- equiv./kg 

Metabolite Fraction (BYI 08330-) %TRR 

mgequiv./

kg 

%TRR 

mgequiv./

kg 

%TRR 

mgequiv./

kg 

%TRR 

mgequiv.

/kg 

%TRR 

mgequiv./

kg 

%TRR 

mgequiv./

kg 

%TRR 

mgequiv./

kg 

desmethyl-di-hydroxy-Glc 2.6 0.001 6.9 0.027 12.7 0.127 4.5 0.001 3.8 0.003 4.3 0.005 -- -- enol-Glc -- -- 1.3 0.005 4.1 0.041 -- -- -- -- -- -- -- -- desmethyl-di-hydroxy -- -- 1.2 0.005 2.5 0.025 2.3 0.001 -- -- 1.9 0.002 -- -- desmethyl-di-hydroxy-Glc-MA -- -- 4.0 0.015 6.0 0.060 1.3 <0.001 5.3 0.004 3.7 0.005 6.0 0.001 ketohydroxy-alcohol-Glc 2.7 0.001 4.7 0.018 5.8 0.058 1.4 <0.001 -- -- 5.3 0.007 -- -- desmethyl-ketohydroxy-Glc (I1) -- -- 10.6 0.041 8.7 0.087 0.8 <0.001 15.2 0.012 -- -- -- -- desmethyl-ketohydroxy-Glc (I2) 31.7 0.008 7.2 0.028 4.4 0.044 0.8 <0.001 9.2 0.007 5.2 0.006 -- -- desmethyl-enol-alcohol 1.6 <0.001 0.8 0.003 0.5 0.005 0.5 <0.001 2.2 0.002 0.3 <0.001 2.8 0.001 di-hydroxy 5.0 0.001 5.3 0.020 5.7 0.057 2.0 0.001 8.1 0.006 1.5 0.002 7.7 0.002 ketohydroxy-alcohol -- -- 6.9 0.027 1.8 0.018 0.8 <0.001 1.6 0.001 6.8 0.008 -- -- desmethyl-ketohydroxy-Glc-MA (I1) 1.8 <0.001 11.5 0.044 8.8 0.088 1.5 <0.001 -- -- -- -- -- -- desmethyl-ketohydroxy-Glc-MA (I2) 2.2 0.001 4.0 0.016 3.8 0.038 1.4 <0.001 -- -- 4.8 0.006 -- -- desmethyl-ketohydroxy 2.3 0.001 0.6 0.002 2.2 0.022 -- -- 0.9 0.001 0.3 <0.001 4.2 0.001 Ketohydroxy 31.4 0.008 8.4 0.032 3.1 0.031 -- -- 17.4 0.014 2.6 0.003 29.5 0.006 Enol -- -- -- -- -- -- 2.9 0.001 -- -- -- -- -- -- Total identified 81.3 0.020 73.5 0.282 70.1 0.700 20.1 0.005 63.7 0.050 36.7 0.045 50.1 0.011 Total characterized 5.3 0.001 20.3 0.078 26.3 0.262 30.0 0.008 27.5 0.021 60.4 0.074 32.5 0.007 Total extractable (conventional) 86.7 0.021 93.6 0.360 92.1 0.919 50.1 0.013 91.3 0.071 97.1 0.120 82.6 0.017 Total bound (solids 1) 13.3 0.003 6.4 0.025 7.9 0.079 49.9 0.013 8.7 0.007 2.9 0.004 17.4 0.004 Total extractable (exhaustive) -- -- -- -- 4.3 0.043 44.5 0.012 -- -- -- -- -- -- Total bound (solids 2) -- -- -- -- 3.6 0.036 5.4 0.001 -- -- -- -- -- -- Accountability 100.0 0.024 100.0 0.384 100.0 0.998 100.0 0.026 100.0 0.078 100.0 0.123 100.0 0.021 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.9.1-2: Summary of Characterization and Identification of Radioactive Residues in 135-day PBI Rotational Crop Matrices Following 

Application of Radiolabeled Spirotetramat at 406 g a.i./ha. 

 wheat forage wheat hay wheat straw wheat grain Swiss chard turnip leaves turnip roots 

TRR 0.021 mg- equiv./kg 0.038 mg- equiv./kg 0.097 mg- equiv./kg 0.010 mg- equiv./kg 0.012 mg- equiv./kg 0.015 mg- equiv./kg 0.003 mg- equiv./kg 

Metabolite Fraction (BYI 08330-) %TRR 

mgequiv./

kg 

%TRR 

mgequiv./

kg 

%TRR 

mgequiv.

/kg 

%TRR 

mgequiv./

kg 

%TRR 

mgequiv.

/kg 

%TRR 

mgequiv./

kg 

%TRR 

mgequiv.

/kg 

desmethyl-di-hydroxy-Glc 18.3 0.004 14.0 0.005 9.2 0.009 4.5 0.001 5.5 0.001 enol-Glc -- -- 1.7 0.001 1.9 0.002 -- -- -- -- desmethyl-di-hydroxy -- -- -- -- 2.9 0.003 -- -- -- -- desmethyl-di-hydroxy-Glc-MA 9.1 0.002 11.5 0.004 5.8 0.006 3.5 <0.001 4.3 0.001 ketohydroxy-alcohol-Glc -- -- 3.2 0.001 1.3 0.001 -- -- 2.6 <0.001 desmethyl-ketohydroxy-Glc (I1) 8.7 0.002 6.5 0.002 7.3 0.007 6.2 0.001 -- -- desmethyl-ketohydroxy-Glc (2) 5.6 0.001 3.2 0.001 2.7 0.003 5.9 0.001 5.5 0.001 desmethyl-enol-alcohol -- -- -- -- -- -- -- -- -- -- di-hydroxy -- -- -- -- 10.6 0.010 16.8 0.002 -- -- ketohydroxy-alcohol -- -- -- -- -- 3.8 <0.001 4.6 0.001 desmethyl-ketohydroxy-Glc-MA (I1) 8.0 0.002 5.4 0.002 5.6 0.005 -- -- -- -- desmethyl-ketohydroxy-Glc-MA (I2) 2.5 0.001 -- -- 2.0 0.002 -- -- -- -- desmethyl-ketohydroxy -- -- -- -- 1.8 0.002 2.3 <0.001 3.5 0.001 ketohydroxy -- -- -- -- 7.1 0.007 14.9 0.002 -- -- enol -- -- -- -- -- -- -- -- -- desmethyl-di-hydroxy-Glc -- -- -- -- -- -- 

NA -- 

-- -- -- -- 

NA -- 

Total identified 52.2 0.012 45.5 0.017 58.3 0.056 -- -- 57.8 0.007 26.0 0.004 -- -- Total characterized *40.3 *0.009 *39.2 *0.015 29.7 0.029 -- -- 26.2 0.003 *59.7 *0.009 -- -- Total extractable (conventional) 92.5 0.021 84.8 0.032 88.0 0.085 21.2 0.002 84.0 0.010 85.7 0.013 71.6 0.002 Total bound (solids 1) 7.5 0.002 15.2 0.006 12.0 0.012 78.8 0.008 16.0 0.002 14.3 0.002 28.4 0.001 Total extractable (exhaustive) -- -- -- -- -- -- 66.8 0.007 -- -- -- -- -- -- Total bound (solids 2) -- -- -- -- -- -- 12.0 0.001 -- -- -- -- -- -- Accountability 100.0 0.021 100.0 0.038 100.0 0.097 100.0 0.010 100.0 0.012 100.0 0.015 100.0 0.003 Turnip roots were not extracted due to TRR <0.01 mg-equiv./kg. Wheat grain extracts were not analysed due to TRR <0.01 mg-equiv./kg * only the aqueous phase was analysed by HPLC (residue level >0.005 mg/kg); the compounds in the DCM phase were characterized due to their behaviour during partitioning 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.9.1-3: Summary of Characterization and Identification of Radioactive Residues in 260-day PBI Rotational Crop Matrices Following 

Application of Radiolabeled Spirotetramat at 406 g a.i./ha. 

 wheat forage wheat hay wheat straw wheat grain Swiss chard turnip leaves turnip roots 

TRR 0.009 mg- equiv./kg 0.014 mg- equiv./kg 0.036 mg- equiv./kg 0.002 mg- equiv./kg 0.006 mg- equiv./kg 0.008 mg- equiv./kg 0.002 mg- equiv./kg 

Metabolite Fraction (BYI 08330-) %TRR 

mgequiv./

kg 

%TRR 

mgequiv./

kg 

%TRR 

mgequiv.

/kg 

%TRR 

mgequiv./

kg 

%TRR 

mgequiv.

/kg 

%TRR 

mgequiv./

kg 

%TRR 

mgequiv.

/kg 

desmethyl-di-hydroxy-Glc 5.4 0.001 5.6 0.002 enol-Glc -- -- -- -- desmethyl-di-hydroxy -- -- -- -- desmethyl-di-hydroxy-Glc-MA 9.7 0.001 4.4 0.002 ketohydroxy-alcohol-Glc -- -- 4.9 0.002 desmethyl-ketohydroxy-Glc (I1) 6.5 0.001 7.8 0.003 desmethyl-ketohydroxy-Glc (2) 2.8 <0.001 4.8 0.002 desmethyl-enol-alcohol -- -- -- -- di-hydroxy -- -- 18.1 0.006 ketohydroxy-alcohol -- -- -- -- desmethyl-ketohydroxy-Glc-MA (I1) 4.2 0.001 7.3 0.003 desmethyl-ketohydroxy-Glc-MA (I2) -- -- 7.6 0.003 desmethyl-ketohydroxy -- -- -- -- ketohydroxy -- -- 5.3 0.002 enol -- -- -- -- desmethyl-di-hydroxy-Glc 

NA -- 

-- -- -- -- 

NA -- NA -- NA -- NA -- 

Total identified -- -- 28.7 0.004 65.9 0.024 -- -- -- -- -- -- -- -- Total characterized -- -- *52.2 *0.007 21.3 0.008 -- -- -- -- -- -- -- -- Total extractable (conventional) -- -- 80.8 0.011 87.3 0.031 -- -- -- -- -- -- -- -- Total bound (solids 1) -- -- 19.2 0.003 12.7 0.005 -- -- -- -- -- -- -- -- Accountability1 100.0 0.009 100.0 0.014 100.0 0.036 100.0 0.002 100.0 0.006 100.0 0.008 100.0 0.002 Wheat hay, wheat grain, Swiss chard, turnip leaves and turnip roots were not extracted due to low TRR (<0.01 ppm) 

* only the aqueous phase was analysed by HPLC (residue level >0.005 ppm), the residues in the DCM phase were characterized due to their behavior during 

partitioning. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Conclusion: 

Parent compound spirotetramat was not detected in any of the samples. Major metabolites (>10% of the 

TRR) in the 30-day and 135-day rotation were: BYI 08330-ketohydroxy, BYI 08330-desmethyl-ketohydroxyGlc (two isomers), BYI 08330-desmethyl-ketohydroxy-Glc-MA (two isomers), BYI 08330-desmethyldihydroxy-Glc, BYI 08330-desmethyl-di-hydroxy-Glc-MA, and BYI 08330-di-hydroxy. Other identified 

metabolites were of minor importance. 

It appears that two major metabolic routes in rotational crops start with the soil metabolites BYI 08330-

ketohydroxy and BYI 08330-enol. The first metabolic route proceeds by demethylation of the cyclohexyl ring 

or hydroxylation of one methyl group of the xylol ring. Another metabolic route starts with the addition of 

water to the tetramic acid ring of BYI 08330-enol resulting in the formation of BYI 08330-di-hydroxy, followed 

by the demethylation of the metabolite. Additionally, hydroxylation of one methyl group of the xylol ring of 

BYI 08330-enol followed by demethylation of the cyclohexyl ring results in BYI 08330-desmethyl-enolalcohol, which was detected in all matrices. Most of the metabolites were rapidly conjugated. Glucosides 

and/or glucosyl malonic acid conjugates were detected for BYI 08330-enol, BYI 08330-desmethyl-di-hydroxy, 

BYI 08330-desmethyl-ketohydroxy and BYI 08330-ketohydroxy-alcohol. The percentage of conjugates 

increased from the 30-day to the 260-day rotation. 

Overall conclusion with relevance for PMRA (Canada) and US EPA::

The submitted confined rotational crop study is adequate to satisfy data requirements. The metabolism of 

spirotetramat in rotational crops appears to be consistent with the pathway observed in the plant metabolism 

studies. The following potential components of the residue definition were identified in the confined rotational 

crop study: BYI08330, BYI08330-ketohydroxy, and free and conjugated BYI08330-desmethyl-ketohydroxy, 

BYI08330-desmethyl-di-hydroxy and BYI-08330-ketohydroxy-alcohol. None of these residues were found in 

the limited rotational crop field trials at a 30-day PBI. Provided a 30-day PBI is specified on the spirotetramat 

labels, residues in rotational crops are not of concern for the risk assessment or for MRL setting. 

Overall conclusion with relevance for EU:

The results of the confined rotational crop study using radiolabelled material show that residues resulting 

from the use of spirotetramat in primary crops might lead to residues >LOQ in rotational crops, which are not 

covered by the residue definition for plant matrices. The crop rotation field studies conducted in 3 different 

regions in the USA (see point B.7.9.2) are considered acceptable as additional information to elucidate, if the 

residue definition for primary crops has to be enlarged or not. 

B.7.9.2 Crop rotation studies (field test) 

Reference: BYI08330 100 OD – Magnitude of the Residue in Field Rotational Crops 

(Limited). 

Author(s), year: Lemke, V. (2006) 

Report/Doc. number: Report No.: RAFNY019, 

Edition Number: M-277284-01-1 

Guideline(s): PMRA Directive 98-02; DACO 7.4.4/EPA OPPTS 860.1900 

GLP: Yes. 

Deviations: None. 

Validity: The study is considered acceptable. 

Material and methods:

The field rotational crop study was conducted in three sites in the US (FL, IL, CA) using BYI 08330 100 OD, 

an oil-dispersible formulation containing 100 g a.i./L spirotetramat. BYI 08330 100 OD was applied, twice at 
- 198 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

5-7 days apart, to a primary crop (leafy, Brassica, or fruiting vegetables) as foliar broadcast spray for a total 

rate of 0.172-0.180 kg a.i./ha (0.153-0.161 lb a.i./A). After primary crops were removed, rotational crops 

(mustard greens, turnips and wheat) were planted at a 30-day plant-back interval (PBI) following the last 

application of BYI 08330 100 OD. 

Residues of spirotetramat and BYI 08330-ketohydroxy were determined using analytical method 00857 with

slight modification. Briefly, a 5.0 g aliquot of crop matrix was extracted with 30 mL of acidic acetonitrile 

(ACN)/water mixture (4/1, v/v) using Polytron blender. After filtration and cleaning-up of the extract, the 

corresponding stable isotopically labelled internal standards were added. Afterwards, the solution was made 

up to volume, and subjected to high-pressure liquid chromatography with triple-stage quadrupole mass 

spectrometry (HPLC-MS/MS). The LOQ was 0.01 ppm each for spirotetramat and BYI 08330-ketohydroxy. 

Analytical method 00929 with slight modification was used to determine residues of BYI 08330-desmethyl-dihydroxy, BYI 08330-desmethyl-ketohydroxy and BYI 08330-ketohydroxy-alcohol in rotational crops. Briefly, 

a 2.5 g aliquot of crop matrix was soaked with 20 mL of ACN/water mixture (4/1, v/v) for 30 minutes and 

blended using a high-speed blender. The extract was filtered through a 20 mL Varian Bond Elute reservoir. 

The filtrate was diluted to 50 mL with ACN/water (1/1, v/v) and concentrated to the aqueous remainder. The 

concentrated extract was hydrolyzed with 10 mL of 3 N HCl/water (1/1, v/v) at 100°C for 1 hour. After

cooling, a mixture of isotopically labelled internal standards was added, and the solution was made up to 

volume, purified through a 20-mL Varian Bond Elute reservoir. The purified solution was concentrated to 

near dryness, reconstituted with ACN/water (1/3, v/v) and analyzed by HPLC-MS/MS. The LOQ is 0.02 ppm

for each analyte. 

Findings:

At maturity, samples of mustard greens, turnip (tops and roots), wheat (forage, hay, straw and grain) were 

collected and analyzed for residues of spirotetramat, BYI 08330-ketohydroxy, BYI 08330-desmethylketohydroxy, BYI 08330-desmethyl-di-hydroxy and BYI 08330-ketohydroxy-alcohol. Adequate methodvalidation data were provided. No residues were detected above the method’s limit of quantitation (LOQ) 

levels in any of the rotational crop matrices. Residues of spirotetramat, BYI 08330-ketohydroxy were 

analyzed using analytical method 00857 with a LOQ of 0.01 ppm for each analyte. Residues of BYI 08330-

desmethyl-ketohydroxy, BYI 08330-desmethy-di-hydroxy and BYI 08330-ketohydroxy-alcohol were analyzed 

using analytical method 00929 with a LOQ of 0.02 ppm for each analyte. The samples were analyzed after

freezer storage of approximately 15 months. Freezer storage stability information is available to show the 

residues of BYI 08330-ketohydroxy, BYI 08330-desmethyl-ketohydroxy, BYI 08330-desmethyl-di-hydroxy 

and BYI 08330-ketohydroxy-alcohol are stable for at least 30 months in the subject crops. 
- 199 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.9.2-1: Residues of spirotetramat equivalents in succeeding crops after application of BYI 08330 100 OD. 

Trial ID 

(City, 

State/Year) 

Zon

e Crop/ Variety Commodity 

Total 

Rate, 

g a.i./ha 

(lb a.i./A) 

Harves

t DAP1

PBI2

(days

) 

Spirotetrama

t (mgequiv./kg) 

BYI 08330 

ketohydroxy 

(mgequiv./kg) 

desmethyldi-hydroxy 

(mgequiv./kg) 

desmethyl

-

ketohydro

xy 

(mgequiv./kg) 

ketohydroxyalcohol 

(mg-equiv./kg) 

Molino, FL 2004 

3 Mustard greens/Giant 

Southern Curled 

greens (leaves) 

177.3 (0.159) 

34 34 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02,

<0.02 

<0.02, <0.02 

Seymour, Il 2004 

5 Mustard greens/Green 

Wave 

greens (leaves) 

178.2 (0.159) 

46 29 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02,

<0.02 

<0.02, <0.02 

Molino, FL 2004 

3 Turnip/Purple Top White 

Globe 

Tops (leaves) 

177.6 (0.158) 

48 34 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02,

<0.02 

<0.02, <0.02 

Seymour, Il 2004 

5 Turnip/Purple Top White 

Globe 

Tops (leaves) 

179.2 (0.160) 

59 29 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02,

<0.02 

<0.02, <0.02 

Molino, FL 2004 

3 Turnip/Purple Top White 

Globe 

Roots 177.6 

(0.158) 

48 34 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02,

<0.02 

<0.02, <0.02 

Seymour, Il 2004 

5 Turnip/Purple Top White 

Globe 

Roots 179.2 

(0.160) 

59 29 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02,

<0.02 

<0.02, <0.02 

Molino, FL 2004 

3 Wheat, winter/Coker 

9125 

Forage 172.0 

(0.153) 

94 35 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02,

<0.02 

<0.02, <0.02 

Seymour, Il 2004 

5 Wheat, winter/IL94-1653 Forage 180.4 

(0.161) 

185 29 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02, 

<0.02 

<0.02, <0.02 

Molino, FL 2004 

3 Wheat, winter/Coker 

9125 

Hay 172.0 

(0.153) 

154 25 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02, 

<0.02 

<0.02, <0.02 

Seymour, Il 2004 

5 Wheat, winter/IL94-1653 Hay 180.4 

(0.161) 

222 29 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02, 

<0.02 

<0.02, <0.02 

Molino, FL 2004 

3 Wheat, winter/Coker 

9125 

Grain 172.0 

(0.153) 

191 35 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02, 

<0.02 

<0.02, <0.02 

Seymour, Il 2004 

5 Wheat, winter/IL94-1653 Grain 180.4 

(0.161) 

257 29 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02, 

<0.02 

<0.02, <0.02 

Molino, FL 2004 

3 Wheat, winter/Coker 

9125 

Straw 172.0 

(0.153) 

191 35 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02, 

<0.02 

<0.02, <0.02 

Seymour, Il 2004 

5 Wheat, winter/IL94-1653 Straw 180.4 

(0.161) 

257 29 <0.01, <0.01 <0.01, <0.01 <0.02, <0.02 <0.02, 

<0.02 

<0.02, <0.02 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Conclusion:

At PBI of 30 days, no residues of spirotetramat, BYI 08330-ketohydroxy, BYI 08330-desmethyl-ketohydroxy, 

BYI 08330-desmethyl-di-hydroxy and BYI 08330-ketohydroxy-alcohol were detected above their LOQ levels 

in rotational crops (mustard greens, turnips and wheat). 

Comment of RMS AT:

The remark “limited” in the study title seems to ground on the following exceptions to the requirements of 

EPA Good Laboratory Practice Standards: weather data, maintenance chemical applications, pesticide 

history data, irrigation records, cultural practices, and field sample weights for the trials were not collected 

under GLP. Nevertheless the study is considered acceptable by PMRA (Canada) and RMS AT. 

B.7.9.3 Overall conclusion 

The submitted field rotational crop data are adequate to satisfy data requirements. The available data 

indicate that residues of the parent and the metabolites (BYI 08330-ketohydroxy, BYI 08330-desmethylketohydroxy, BYI 08330-desmethyl-di-hydroxy and BYI 08330-ketohydroxy-alcohol) were each <0.020 ppm 

in/on all rotational crop matrices at a 30-day PBI. These data support a rotational crop restriction of 30 days 

for all non-labeled crops. Unless the applicant requests PBIs shorter than 30 days, no additional data are 

required, and MRLs for inadvertent residues in/on rotational crops need not be established in conjunction 

with the currently proposed uses. 

Comments RMS Austria with relevance for EU:

The expected residues in rotational crops are covered sufficiently by the residue definition for the expression 

of the MRL/monitoring and risk assessment for plant commodities (spirotetramat and the metabolites BYI

08330-enol, BYI 08330-ketohydroxy, BYI08330-enol-Glc, and BYI 08330-mono-hydroxy), based on the 

outcome of the field trials in succeeding crops, which are accepted by RMS Austria as additional information. 

B.7.10 Proposed pre-harvest intervals for envisaged uses, or withholding periods, in the case 

of post harvest uses (Annex IIA 6.8; Annex IIIA 8.8) 

Table Table B.7.10-1: PHI proposed by the notifier after application of spirotetramat. 

Relevant for EU:

Crop Food/feed item PHI [days] 

Citrus Food item 14 

Lettuce (head and leafy) Food item 7 

Pome fruit (apple, pear) Food item 21 

Stone fruit (plum, sour and sweet 

cherry, peach, apricot, nectarine) 

Food item 21 

Grapes Food item 14 

Strawberries Food item 3 

Onions Food item 7 

Fruiting vegetables (tomatoes, 

peppers, aubergines) 

Food item 3 

Cucurbit vegetables (cucmbers, 

courgettes, melon, watermelon) 

Food item 3 

Flowering brassica (cauliflower, 

broccoli), 

head cabbage (red and white 

savoy) 

Food item 3 

Brussel sprouts, kohlrabi Food item 3 

Leafy brassica Food and feed item 3 

Beans, green Food item 14 

Hops Food item 14 

Note: grey marked data are only intended for MRL setting in the EU. 
- 201 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.11 Community MRL and MRLs in EU Member States (Annex IIIA 11.2) 

B.7.12 Proposed EU MRLs and justification for the acceptability of those MRLs (Annex IIA 

6.7; Annex IIIA 8.7) 

Table B.7.12-1: Proposed MRLs for Food of plant origin 

Commodity 

Proposed EU-MRLs 

according to the 

intended uses 

[mg/kg]1)

Comments 

Citrus 1 Import tolerance (0.5 mg/kg based on EU-GAP) 

Lettuce 5 --- (No import tolerance. Intended for use in 

NAFTA, but no residue data submitted.) 

Tree nuts 0.5 Import tolerance (no EU-GAP) 

Pome fruit 1 Import tolerance (0.3 mg/kg based on EU-GAP) 

Peach / Apricots 2 Import tolerance (1 mg/kg based on EU-GAP) 

Cherries 5 Import tolerance (1 mg/kg based on EU-GAP) 

Plums 2 Import tolerance (2 mg/kg also based on EU-GAP)

Grapes 2 Import tolerance (1 mg/kg based on EU-GAP) 

Strawberries 1 --- 

Potatoes 0.5 Import tolerance (no EU-GAP) 

Onions 0.3 --- 

Tomatoes 2 --- 

Peppers 2 Import tolerance (2 mg/kg also based on EU-GAP) 

Aubergines 2 Extrapolated from tomatoes. 

Cucumbers 0.2 Import tolerance (0.2 mg/kg also based on EUGAP) 

Courgettes 0.2 Extrapolated from cucumbers. 

Cucurbits (inedible peel) 0.3 Import tolerance 

Flowering brassica 1 Import tolerance (1 mg/kg based on EU-GAP) 

Brussel sprouts 0.3 --- 

Head cabbage 2 Import tolerance (0.5 mg/kg based on EU-GAP) 

Leafy brassica 10 Import tolerance (2 mg/kg based on EU-GAP) 

Kohlrabi 2 --- 

Green beans 2 --- 

Hops 20 Import tolerance (10 mg/kg based on EU-GAP) 

1) Residues expressed in mg spirotetramat /kg 

B.7.12.1 Food of animal origin 

Proposal relevant for EU:

Basing on the results of the livestock feeding study, a MRL of 0.02 mg/kg is proposed for bovine, sheep, goat 

and swine kidney. For other edible tissues no MRL is required (LOQ at 0.01 mg/kg), also not for milk (LOQ at 

0.005 mg/kg). 

Table B.7.12.1-1: EU-MRLs Proposed by RMS for Food of animal origin 

Commodity 

Proposed EU-MRLs according to 

the intended uses 

[mg/kg]1)

Comments 

Kidney (bovine, goat, sheep, swine) 0.02 --- 

1) Residues expressed in mg spirotetramat /kg 
- 202 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.12.1-2: MRLs Proposed by Canada for Food of animal origin 

Commodity 

Proposed NAFTA-MRLs according 

to the intended uses 

[mg/kg]1)

Comments 

Milk 0.01 --- 

Cattle, meat 0.02 --- 

Cattle, fat 0.02 --- 

Cattle, meat byproducts 0.02 --- 

Goat, meat 0.02 --- 

Goat, fat 0.02 --- 

Goat, meat byproducts 0.02 --- 

Sheep, meat 0.02 --- 

Sheep, fat 0.02 --- 

Sheep, meat byproducts 0.02 --- 

Horse, meat 0.02 --- 

Horse, fat 0.02 --- 

Horse, meat byproducts 0.02 --- 

1) Residues expressed in mg spirotetramat /kg 

B.7.13 Proposed EU import tolerances and justification for the acceptability of those 

residues 

Please refer to Annex III (the evaluation of the import tolerances has been performed by UK within the

worksharing project on spirotetramat). The proposed import tolerances are summarised in the following 

table. 

Table B.7.13-1: Import tolerances 

Commodity 

Proposed import 

tolerances according to 

the intended uses 

[mg/kg]1)

Comments 

Citrus 1 Proposal by Canada: 0.6 mg/kg; difference 

between the two proposals based on different 

calculation-models and/or MRL-classes. 

Tree nuts 0.5 Proposal by Canada: 0.25 mg/kg; difference 

between the two proposals based on different 

calculation-models and/or MRL-classes. 

Almond hulls: 9 mg/kg (proposal Canada) is not 

considered as this is no food item in EU. 

Pome fruit 1 Proposal by UK 0.5 mg/kg (according to Method I 

and II calculation: 1 mg/kg might be more 

appropriate; covering Canada’s proposal of 0.7 

mg/kg). 

Apricots 2 Extrapolation from NAFTA peach data 

Canada’s proposal: 4.5 mg/kg (group tolerance 

stone fruits – based on cherry data?) 

Cherries 5 Canada’s proposal: 4.5 mg/kg (group tolerance 

stone fruits) difference between the two proposals 

based on different calculation-models and/or MRLclasses. 

Peaches 2 Canada’s proposal: 4.5 mg/kg (group tolerance 

stone fruits – based on cherry data?) 

Plums 2 Based on 6 trials only (major crop in N-EU).. 

Proposal by Canada: 4.5 mg/kg; (group tolerance 

stone fruits – based on cherry data?) 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Commodity 

Proposed import 

tolerances according to 

the intended uses 

[mg/kg]1)

Comments 

Grapes 2 Proposal by Canada: 1.3 mg/kg; difference 

between the two proposals based on different 

calculation-models and/or MRL-classes. 

Potatoes 0.5 Proposal doesn’t cover Canadas MRL of 0.6 

mg/kg: 

difference between the two proposals based on 

different calculation-models and/or MRL-classes. 

Peppers 2 Corresponding to MRL-proposal based on critical 

EU-GAP (glasshouse) 

Cucumbers 0.2 Corresponding to MRL-proposal based on critical 

EU-GAP (glasshouse); 

Canada’s proposal: 0.3 mg/kg, based on different 

calculation models 

Cucurbits, inedible peel 0.3 Corresponds to proposal by Canada 

Flowering brassica 2 Proposal by Canada: 2.5 mg/kg; difference 

between the two proposals based on different 

calculation-models and/or MRL-classes. 

Head cabbage 2 Proposal by Canada: 2.5 mg/kg; difference 

between the two proposals based on different 

calculation-models and/or MRL-classes. 

Leafy brassica 10 Proposal by Canada: 8.0 mg/kg; difference 

between the two proposals based on different 

calculation-models and/or MRL-classes. 

Lettuce (and other salad plants 

including Brassicacea) 

--- Intended for use in NAFTA, but no residue trials 

submitted. 

Hops 20 Based on 3 trials only. Proposal by Canada: 10.0 

mg/kg; difference between the two proposals 

based on different calculation-models and/or MRLclasses. 

B.7.14 Basis for differences, if any, in conclusions reached having regard to established or 

proposed CAC MRLs 

No differences, as no CAC MRLs are established or proposed at the moment. 

B.7.15 Estimates of potential and actual dietary exposure through diet and other means 

(Annex IIA 6.9; Annex IIIA 8.10) 

B.7.15.1 Estimation of the potential and actual exposure through diet 

B.7.15.2 Estimation of chronic exposure through diet 

The long term risk assessment is based on the ADI (0.05 mg/kg bw/day). TMDI-calculation was carried out 

by means of the EFSA chronic acute RA model rev.2, including also the diet consumption data obtained 

from the European diet compiled in the WHO Publication on Cultural and Global Diets, 1994; as well as the 

diet consumption data obtained from the new German diet (VELS intake model for a child of 16.15 kg 

bodyweight). The proposed MRLs / import tolerances were used for calculation. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Table B.7.15.2-1: Theoretical Maximum Daily Intake (TMDI) of spirotetramat residues presented as 

% exhaustion of the Acceptable Daily Intake: 

Highest 

calculated TMDI 

values in % of 

ADI 

MS Diet 

Highest 

contributor to MS 

diet 

(in % of ADI) 

Commodity / 

group of commodities 

58.4 DE child 24.1 Apples 

47.8 NL child 12.7 Apples 

46.5 WHO Cluster diet B 12.3 Tomatoes 

33.4 IE adult 5.0 Wine grapes 

29.3 FR toddler 5.2 Apples 

27.5 PT General population 10.0 Wine grapes 

25.9 FR all population 16.0 Wine grapes 

25.0 WHO cluster diet D 4.1 Potatoes 

24.6 WHO regional European diet 4.4 Tomatoes 

24.4 SE general population 90th 

percentile 

4.2 Potatoes 

24.4 WHO cluster diet E 6.4 Wine grapes 

22.6 NL general 3.0 Oranges 

22.4 ES child 4.3 Oranges 

21.2 WHO Cluster diet F 3.4 Potatoes 

20.7 ES adult 5.4 Lettuce 

19.6 FR infant 5.0 Apples 

19.0 IT kids/toddler 5.7 Tomatoes 

18.4 IT adult 4.7 Tomatoes 

18.2 UK Toddler 4.0 Oranges 

18.1 PL general population 4.1 Apples 

17.1 DK child 4.6 Apples 

15.3 UK vegetarian 3.3 Wine grapes 

15.0 UK Infant 3.3 Potatoes 

13.8 DK adult 5.6 Wine grapes 

13.3 UK Adult 4.3 Wine grapes 

13.0 LT adult 3.7 Apples 

10.1 FI adult 1.9 Oranges 

TMDI (range) in % of ADI: Minimum: 10 Maximum: 58

Conclusion: 

The estimated Theoretical Maximum Daily Intakes (TMDI) was below the ADI. A long-term intake of residues 

of spirotetremat is unlikely to present a public health concern. 

B.7.15.2.1 Estimation of acute exposure through diet 

IESTI-calculation was carried out by means of the EFSA chronic acute RA model rev.2, including also the 

diet consumption data obtained from the new UK diet (Acute Intakes; 97.5th percentiles), as well as the diet 

consumption data obtained from the new German diet (VELS intake model for a child of 16.15 kg 

bodyweight). 

The acute risk assessment is based on the ARfD (1 mg/kg bw). For each commodity the calculation is based 

on the highest reported MS consumption per kg bw and the corresponding unit weight from the MS with the 

critical consumption. If no data on the unit weight was available from that MS an average European unit 

weight was used for the IESTI calculation. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

In the IESTI 1 calculation, the variability factors were 10, 7 or 5 (according to JMPR manual 2002), for lettuce 

a variability factor of 5 was used. 

In the IESTI 2 calculations, the variability factors of 10 and 7 were replaced by 5. For lettuce the calculation 

was performed with a variabilty factor of 3. 

Table B.7.15.2.1-1: International Estimates Short Term Intake (IESTI) of spirotetramat residues 

presented as % exhaustion of the Acute Reference Dose: 

IESTI 1 IESTI 2 

Highest % of ARfD Commodities Highest % of ARfD Commodities 

67.6 Kale 48.3 Kale 

37.1 Chinese cabbage 37.1 Chinese cabbage 

13.5 Lettuce 13.2 Cauliflower 

13.3 Oranges 13.1 Table grapes 

13.2 Cauliflower 10.0 Kohlrabi 

The results of the IESTI calculations are reported for at least 5 commodities. If the ARfD is exceeded for 

more than 5 commodities, all IESTI values > 90% of ARfD are reported. 

Conclusion: 

No exceedance of the ARfD was identified. 

A short term intake of residues of spirotetremat is unlikely to present a public health risk 

B.7.15.3 Estimation of the potential and actual exposure through other means 

No spirotetramat residues above 0.1 μg/L are expected to occur in drinking water. Spirotetramat residue 

intake through drinking water can therefore be assessed as theoretical maximum: 0.2 μg 

spirotetramat/person/day assuming a daily consumption of 2 L water. This contribution is considered 

marginal compared to the theoretical maximal intake of spirotetramat through food of plant and animal origin. 

B.7.16 Summary and evaluation of residue behaviour (Annex IIA 6.11.1; Annex IIIA 8.11) 

The metabolism of [azaspirodecenyl-3-14C]-spirotetramat in plants was investigated in apples, lettuce, 

cotton and potatoes. 

Head lettuce was treated with two spray applications of [azaspirodecenyl-3-14C]-spirotetramat, formulated as 

an oil-dispersion formula (100 OD), at a total rate of 167 g a.i./ha (0.15 lbs a.i./A). The two applications were 

made at a 14-day retreatment interval. Treated lettuce was harvested at maturity 7 days after the last 

treatment. More than 95% of the total radioactive residue (TRR) in lettuce was extracted with acetonitrile 

(ACN)/water. The TRR was 3.13 mg-equiv./kg, calculated by summing extracts and post extraction solids.

Over 91% of the extracted radioactivity was identified. Unchanged parent compound spirotetramat was the 

major residue identified (55.9% TRR), followed by BYI 08330-enol (17.8%), BYI 08330-enol-glucoside 

(11.4% TRR), and BYI 08330-ketohydroxy (6.2% TRR). 

The metabolism of spirotetramat was investigated in potatoes (tuber & tops) following three spray 

applications of [azaspirodecenyl-3-14C]-spirotetramat, formulated as an oil dispersion (100 OD), at a total rate 

of 308 g a.i./ha (0.275 lbs. a.i./A). The applications were made at a 21-day re-treatment interval (RTI). Potato 

samples were harvested 14 days after the last treatment. Approximately 80% of the total radioactive residue 

(TRR) in tuber, and 96% of the TRR in tops were extracted with acetonitrile (ACN)/water. Enzymatic 

treatment of the extracted tuber released approximately 14% of the TRR. The TRR in tuber and tops was 

0.255 mg-equiv./kg and 11.057 mg-equiv./kg, respectively, calculated by summing extracts and post 

extraction solids. Parent spirotetramat was not identified in potato tuber. The predominant metabolite

identified was BYI 08330-enol (65.8% TRR), followed by BYI 08330-ketohydroxy (6.8% TRR) and BYI 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

08330-desmethyl-enol (6.7% TRR) and several other minor metabolites (≤2.5 % of the TRR). In potato tops, 

spirotetramat and BYI 08330-ketohydroxy were the major residues identified. 

The metabolism of spirotetramat was investigated in apple (fruits & leaves) following two spray applications 

of [azaspirodecenyl-3-14C]-spirotetramat, formulated as an oil-dispersion formula (100 OD), at a total rate of 

1100 g a.i./ha (0.982 lb a.i./A). The first application was at a growth stage 69 of the current BBCH code and 

the second application was 20 days later at growth stage 71, 2 months (63 days) before harvest. Total 

radioactive residue (TRR) amounted to 0.61 mg-equiv./kg (apple) and 36.63 mg-equiv./kg (apple leaves).

Approximately 49% in apple was surface residues washed with dichloromethane. Washed apple extracted 

with acetonitrile (ACN)/water yielded 49.5% of the TRR leaving only 2.1% of the TRR as unextractable 

residues. Unchanged parent spirotetramat was the only residue detected in the surface wash. The 

predominant residue found in the extract was BYI 08330-mono-hydroxy followed by BYI 08330-ketohydroxy,

BYI 08330-di-hydroxy, BYI 08330-desmethyl-ketohydroxy, BYI 08330-enol, and the respective glycosides 

thereof. As in apple fruits, the major residue in apple leaves was the unchanged spirotetramat (72% of the 

TRR). Other residues detected were BYI 08330-ketohydroxy, BYI 08330-enol, and glycoside isomers of BYI

08330-desmethyl-ketohydroxy. A BYI 08330-ketohydroxy-formiate-glycoside was also detected. 

Major metabolic reaction involved the hydrolytic cleavage of the carbonate ester parent bond of the parent 

compound to form BYI 08330-enol. Further reduction of the double bond in the teramic acid moiety of BYI 

08330-enol occurred to form the BYI 08330-mono-hydroxy metabolite. Hydroxylation in the tetramic acid

moiety resulted in BYI 08330-ketohydroxy. Demethylation of the methoxy group of the cyclohexyl ring 

resulted via a proposed intermediate (BYI 08330-desmethyl-enol) in BYI 08330-desmethyl-ketohydroxy (after 

the corresponding hydroxylation). Oxidation of the methoxy group resulted in BYI 08330-ketohydroxyformiate. Partly, metabolites bearing a hydroxy group were conjugated with glucose. 

The metabolism of spirotetramat was investigated in cotton (gin trash, lint & undelinted seeds) following two 

spray applications of [azaspirodecenyl-3-14C]-spirotetramat, formulated as a suspension concentrate (240 

SC), at a total rate of 264 g a.i./ha/season (0.23 lbs. a.i./A). The first application was made at an early growth 

stage (BBCH 15) at a rate of 91.7 g a.i./ha, and the second at growth stage 85 (134 days interval) at a rate of 

172.3 g a.i./ha. One immature cotton plant sample was collected at 19 days after the first application. Cotton 

gin trash, lint and undelinted seed samples were harvested 39 days after the last treatment. The total

radioactive residue (TRR) was 2.381 mg-equiv./kg in the immature plant sample, 1.641 mg-equiv./kg in gin 

trash, 1.078 mg-equiv./kg in lint, and 0.119 mg-equiv./kg in undelinted seed. Parent compound, 

spirotetramat, was the major residue (46.95% TRR) identified in the immature cotton plant. 

Also found were 13 minor metabolites ranging from 0.18% to 9.76% TRR. The major residues identified in

cotton gin trash were BYI 08330-ketohydroxy (29.7% TRR), spirotetramat (19.8% TRR), and BYI 08330-enol 

(12.1% TRR). The major residues identified in cotton lint were spirotetramat (32.3% TRR), BYI 08330-

mandelic acid amide (11.9% TRR), and BYI 08330-ketohydroxy (10.5% TRR). The major residue found in 

the cotton undelinted seeds was BYI 08330-enol (39.8% TRR), while BYI 08330-ketohydroxy represented 

9.04% of the TRR (0.011 mg-equiv./kg). Ten metabolites representing 0.6-4.4% of the TRR (0.003-0.064 

mg-equiv./kg) were also found in the gin trash, lint and undelinted seeds. 

In cotton, cleavage of the pyrrolidine ring of BYI08330-ketohydroxy followed by decarboxylation and further 

cleavage reactions led to the formation of BYI08330-MA-amide, BYI08330-olefin, BYI08330-mandelic acid 

amide, and BYI08330-mandelic acid. Ring closure of the initial cleavage product formed BYI08330-

hydroxymorpholinedione. 

Livestock metabolism studies were performed in ruminants and poultry: 

Following 4 daily oral administrations of [azaspirodecenyl-3-14C]-spirotetramat to one lactating goat at a 

mean dose rate of 2.22 mg a.i./kg bw/day (73.03 mg/kg in feed) given by gavage, concentrations of 

radioactivity in milk were low, reaching a maximum of 0.0261 mg equivalents/kg following the fourth dose. A 

plateau level in milk was reached within the run of the study (96 h). Approximately 90% of the administrated 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

dose was eliminated via urine (78.4%), feces (11.6%), milk (0.014%), and edible organs/tissues (0.061%). 

The highest total radioactive residue (TRR) was observed in kidney (0.184 mg-equiv./kg) and liver (0.05 mgequiv./kg). Significantly lower residues were detected in the muscle and fat. 

The parent compound was not detected in samples of milk, muscle, fat, liver and kidney. The major 

metabolites detected were BYI 08330-enol (33.7-78.4% of the TRR) and BYI 08330-enol-glucuronide (14.2-

37.4% of the TRR). Three other minor metabolites (BYI 08330-ketohydroxy, BYI 08330-desmethyl-enol, and 

BYI 08330-mono-hydroxy) were found each at less than 10% of the TRR. 

Following oral administration of [azaspirodecenyl-3-

14C]spirotetramat to 6 laying hens at a nominal dose level 

of 1.01 mg a.i./kg bw/day (12.86 mg/kg in feed) once daily for 14 consecutive days, concentrations of 

radioactivity in eggs reached a maximum of 0.014 -0.016 mg equivalents/kg at day 6-14. 

The majority of the radioactivity (90% of the administered dose, AD) was detected in the excreta. Only 

0.045% and 0.023% of the total AD were detected in the eggs and edible organs/tissues, respectively. The 

highest total radioactive residue (TRR) was detected in kidneys (0.039 mg-equiv./kg) and liver (0.017 mgequiv./kg), followed by fat (0.004 mg-equiv./kg), and muscle (0.003 mg-equiv./kg). The average TRR in eggs 

was 0.015 mg-equiv./kg. 

The parent compound was not detected in any of the samples. BYI 08330-enol was the major metabolite 

detected in eggs, liver, fat and muscle (18-84% of the TRR; 0.001-0.013 mg-equiv./kg). The glucuronic acid 

conjugate BYI 08330-enol-GA was also detected in eggs (6.9% TRR), muscle (4.2% TRR) and liver (15.1% 

TRR). 

The biodegradation of spirotetramat in livestock can be characterized as cleavage of the carbonate ester 

group to the primary metabolite BYI 08330-enol followed by conjugation of the enol hydroxy group with 

glucuronic acid to BYI 08330-enol-GA. Oxidation of the azaspirodecenyl moiety to BYI 08330-ketohydroxy 

and demethylation of the methoxy group to BYI 08330-desmethyl-enol were minor metabolic reactions in 

ruminants as well as reduction of the azaspirodecenyl moiety to BYI 08330-monohydroxy. 

The residue definition for the expression of the MRL/monitoring and risk assessment for plant 

commodities are spirotetramat and the metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI08330-

enol-Glc, and BYI 08330-mono-hydroxy. 

Based on the currently proposed uses, the residue definition for the expression of the MRL/monitoring for 

livestock commodities are spirotetramat and the metabolite BYI 08330-enol and the residue definition for 

the risk assessment for livestock commodities are spirotetramat and the metabolites BYI 08330-enol and BYI 

08330-enol-GA. 

Relevant for EU:

Considering that the residue definitions for enforcement and for the riskassessment are different for food of 

animal origin, conversion factors could be proposed for the riskassessment based on the metabolism 

studies. Regarding the low-to-zero residue situation in food of animal origin shown in the livestock feeding 

study, it is not considered necessary to propose conversion factors.

Results from supervised residue trials in lettuce and citrus are reported representing the designated 

intended uses of this Annex II dossier for Annex I inclusion of spirotetramat (BYI08330). 

In addition, residue data from uses of spirotetramat in pome fruit, stone fruit, grapes, strawberries, onions, 

fruiting vegetables, brassica vegetables and hops are reported and evaluated in order to accelerate the fixing 

of MRLs with respect to Regulation 396/2005/EC. Thus, all possible MRLs are “peer-reviewed” and there is 

no need for additional work load after Annex I – inclusion for spirotetramat (approach supported by EFSA). 

Spirotetramat is applied as a spray solution to the different crops. Different formulations of spirotetramat 

were used: In 2004, residue trials were conducted with the OD 100 formulation of BYI08330. Due to a minor 

change of the final formulation from OD 100 to OD 150, residue trials in 2005 were conducted with the OD 

150 formulation of BYI08330. The composition of both formulations is similar, but the amount of the active 

substance is 100 g as/L in the OD 100 formulation and 150 g as/L in the OD 150 formulation. Applied at
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

identical use rates for the active substance, both formulations are considered to be comparable with respect 

to residues. 

Results from additional residue trials are reported, which were conducted using a SC 240 formulation or a 

SC 048 formulation of BYI08330 (with the addition of 0.2 % rape methyl ester) to the spray solution. The 

results of these trials are reported to give a complete picture of the BYI08330 residue behaviour. 

Analysis of residue samples was conducted according to method 00875 (see Chapter IIA 4.3). The single 

analytes (spirotetramat and its metabolites BYI08330-enol, -ketohydroxy, -monohydroxy and -enol-glucoside) 

are determined by HPLC-MS/MS. The results are expressed as parent equivalents. The total residue of 

spirotetramat is calculated by summing up the values determined for the individual analytes expressed as 

parent equivalent. Expressed as parent equivalents the LOQ is 0.01 mg/kg for spirotetramat, 0.012 mg/kg for 

BYI08330-enol, -ketohydroxy and –monohydroxy and 0.08 mg/kg for BYI08330-enol-glucoside. For hop 

cones the respective LOQs are by a factor of 10 higher. The LOQ for the calculated total residue of 

BYI08330 is quoted at 0.054 mg/kg (hops 0.54 mg/kg). 

Storage stability studies were conducted for all crops analysed for Spirotetramat residues. Adequate 

method-validation data were provided. Individual analytes showed varying degrees of degradation over the 

course of the study. 

Total residues (calculated as the summation of the single spiked analyte and all detectable analytes resulting 

from the degradation of the spiked compound) were stable (<30% degradation) in tomato fruit, potato tubers, 

lettuce heads, climbing French bean, and almond nutmeat during frozen storage for up to 540 days. 

Total residues of spirotetramat in orange juice and prunes spiked with spirotetramat and the metabolites BYI 

08330-enol, BYI 08330-ketohydroxy, BYI 08330-mono-hydroxy, BYI 08330-enol-Glc were stable (<30% 

degradation) during frozen storage for up to 144 days. 

The residues of wheat (hay, straw and grain), Swiss chard, and turnip (leaves and roots) from the confined 

rotational crop study stable after a storage period of at least 30 months. 

For investigation of the effects on the nature of the residue during processing, the behaviour of BYI 

08330 and its four metabolites BYI08330-enol, BYI08330-enol-glucoside, BYI08330-ketohydroxy and 

BYI08330-monohydroxy in buffer solution in three representative sets of hydrolysis conditions was studied. 

BYI 08330 was demonstrated to be resistant to hydrolysis under conditions being representative for 

pasteurization. Under conditions representative for baking, boiling and brewing 15 % of BYI 08330 degraded 

to BYI08330-enol. Under conditions of sterilization the active substance was nearly completely hydrolysed to 

BYI08330-enol. BYI 08330-enol was detected as the only hydrolysis product. 

BYI 08330-enol was shown to be resistant to hydrolysis under all test conditions. 

BYI 08330-enol-glucoside was resistant to hydrolysis under conditions representative for pasteurisation. 

Under conditions representative for baking, brewing and boiling ca.10 % of the test substance was 

hydrolysed to BYI 08330-enol. Under conditions of sterilization ca. 40 % of the BYI 08330-enol-glucoside 

was hydrolysed to the enol metabolite. 

BYI 08330-ketohydroxy was demonstrated to be resistant to hydrolysis under conditions of pasteurisation. 

Under conditions of baking, brewing and boiling a slight degradation to BYI 08330-MA-amide was found 

(5%). Under conditions of sterilisation BYI 08330-ketohydroxy was completely hydrolysed to BYI 08330-MAamide. 

BYI 08330-monohydroxy was shown to be resistant under all test conditions. 

Relevant for EU:

Estimation of the dietary burden for livestock animals: 

Residues of Spirotetramat in animal feed might occur after treatment of head and leafy brassica, when kale 

or/and cabbage are fed to livestock. Residues might also be found in animal feed after treatment of citrus or 
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pome fruit, when citrus dried pulp or apple wet pomace are fed to cattle. The dietary burden, taking into 

account the highest residue, is 0.273 mg/kg diet for chicken and 1.91 mg/kg diet for dairy cattle. 

Although the dietary burden for chicken exceeds the trigger of 0.1 mg a.s./kg feed, no residues of total 

spirotetramat above 0.01 mg/kg are expected in edible tissues or eggs with respect to the metabolism study 

in laying hens. Therefore no feeding study in poultry was required. 

In consequence of the dietary burden of 1.9 mg a.i./kg feed (dry weight basis), a feeding study in dairy 

cattle was designed to quantify the residues found in tissues and milk from dairy cows following oral 

administration of spirotetramat. 

Spirotetramat was administered via capsule to ten lactating Holstein dairy cows for 29 consecutive days. The 

target dose rates (based on feed dry weight) were 0 mg/kg feed/day (control), 3.0 mg/kg feed/day, 9.0 mg/kg 

feed/day, or 30 mg/kg feed/day. 

Total spirotetramat residue in the milk samples from the 30-mg/kg feeding level were at or below the LOQ 

(0.005 mg/kg) in all cows throughout the study with the exception of a maximum residue of 0.006 mg/kg in 

one cow on study day 10. Residues of parent equivalents did not concentrate in samples of skim milk or milk 

fat separated from whole milk. A low tissue burden was observed, with the highest residues found in kidney 

at the three dosing levels (0.022 mg/kg, 0.075 mg/kg and 0.274 mg/kg, respectively). At the 3-mg/kg dosing 

level, average residues of spirotetramat equivalents were less than the LOQ (0.01 mg/kg) in fat, muscle and 

liver. 

Relevant for EU:

Processing studies were conducted under household or industrial conditions, respectively, to investigate 

the residue levels in the following fractions: 

Orange juice and marmalade; apple sauce and juice (as well as possible feed item wet pomace); cherry fruit 

preserve; raisins; wine; tomato juice, preserve and puree; cooked beans as well as beer. The resulting

transfer factors (<1) show that no concentration of total spirotetramat residues takes place during processing, 

with the exception of apple wet pomace (transfer factor 2.5) which is relevant for animal feed, and in raisins 

(transfer factor 2.7). 

The metabolism in rotational crops (spring wheat, Swiss chard and turnips) was investigated following 

spray application of [azaspirodecenyl-3-14C] spirotetramat onto bare soil at an application rate of 406 g 

a.i./ha. The total radioactive residues (TRRs) were highest in wheat straw of the 30-day rotation (0.998 

mg/kg). In the 260-day rotation, only wheat hay and wheat straw showed residues above 0.01 mg/kg. A 

significant decline of TRRs from the 30-day to the 260-day rotation was observed in all raw agricultural 

commodities (RACs). The lowest residues were generally detected in the edible matrices wheat grain and

turnip roots, followed by Swiss chard. 

Parent compound spirotetramat was not detected in any sample. The percentage of conjugates increased 

from the 30-day to the 260-day rotation. The following potential components of the residue definition (>10% 

TRR) were identified in the confined rotational crop study: BYI08330, BYI08330-ketohydroxy, and free and 

conjugated BYI08330-desmethyl-ketohydroxy, BYI08330-desmethyl-di-hydroxy and BYI-08330-ketohydroxyalcohol. None of these residues were found in the rotational crop field trials >0.020 mg/kg in/on all 

rotational crop matrices at a 30-day PBI. 

Relevant for EU:

The results of the confined rotational crop study using radiolabelled material show that residues resulting 

from the use of spirotetramat in primary crops might lead to residues >LOQ in rotational crops, which are not 

covered by the residue definition for plant matrices. The crop rotation field studies conducted in 3 different 

regions in the USA are considered acceptable as additional information to elucidate, if the residue definition 

for primary crops has to be enlarged or not. 

The expected residues in rotational crops are covered sufficiently by the residue definition for the expression 

of the MRL/monitoring and risk assessment for plant commodities (spirotetramat and the metabolites BYI
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

08330-enol, BYI 08330-ketohydroxy, BYI08330-enol-Glc, and BYI 08330-mono-hydroxy), based on the 

outcome of the field trials in succeeding crops, which are accepted by RMS Austria as additional information. 

Table B.7.16-1: Key results of crop residue trials conducted with spirotetramat (with relevance to 

MRL-estimation; EU-uses) 

Crop Application 

[kg a.s./ha] Region1) No. of trials PHI [days] 

Lowest 

residue at 

harvest 

[mg/kg]2)

Highest residue at 

harvest 

[mg/kg]2)

Citrus 2 x 0.288 S 17 14 - 28 0.064 0.331 

Lettuce 2 x 0.072 G 8 7 0.163 2.327 

Pome fruit 2 x 0.216 N 13 21 - 27 0.064 0.254 

Pome fruit 2 x 0.216 S 12 20 - 28 <0.054 0.249 

Peach / 

Apricots 

2 x 0.180 S 9 20 - 22 0.115 0.687 

Plums 2 x 0.216 N 8 21 – 28 0.119 0.828 

Plums 2 x 0.216 S 4 21 0.135 0.485 

Cherries 2 x 0.216 N 7 21 – 28 0.248 0.939 

Cherries 2 x 0.216 S 4 21 0.629 1.045 

Grapes 2 x 0.096 S 10 14 – 15 0.167 0.641 

Strawberries 2 x 0.096 G 8 3 – 7 0.205 0.328 

Onions 4 x 0.072 N 8 7 – 8 <0.054 0.202 

Onions 4 x 0.072 S 8 7 – 21 <0.054 0.172 

Tomatoes 4 x 0.144 G 8 3 – 7 0.215 0.736 

Peppers 4 x 0.1305 G 12 3 – 7 0.268 0.581 

Cucumbers 4 x 0.144 G 8 3 <0.054 0.077 

Melons 4 x 0.072 G 8 3 – 5 <0.054 0.057 

Flowering 

brassica 

3 x 0.072 N 9 3 – 14 0.11 0.578 

Flowering 

brassica 

3 x 0.072 S 4 3 – 14 0.130 0.439 

Brussel 

sprouts 

3 x 0.072 N 8 3 – 21 0.088 0.218 

Head 

cabbage 

3 x 0.072 N 10 3 – 14 0.067 0.261 

Head 

cabbage 

3 x 0.072 S 4 7 – 21 0.082 0.232 

Leafy 

brassica 

3 x 0.072 N 4 3 – 8 0.240 0.765 

Leafy 

brassica 

3 x 0.072 S 4 3 – 7 0.212 0.631 

Kohlrabi 3 x 0.072 N 4 3 – 7 0.152 0.670 

Green beans 4 x 0.144 G 8 14 – 21 0.082 0.624 

Hops 2 x 0.175 N 8 13 - 22 1.11 4.34 

1) N: Northern Region of Europe; S: Southern Region of Europe 

2) Residues expressed as spirotetramat 

Table B.7.16-2: MRL proposals for spirotetramat (based on the intended uses / Import tolerances). 

Commodity 

Proposed EU-MRLs 

according to the 

intended uses/import 

tolerances 

[mg/kg]1)

Comments 

Citrus 1 Import tolerance (0.5 mg/kg based on EU-GAP) 

Lettuce 5 --- (No import tolerance. Intended for use in 

NAFTA, but no residue data submitted.) 

Tree nuts 0.5 Import tolerance (no EU-GAP) 
- 211 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Commodity 

Proposed EU-MRLs 

according to the 

intended uses/import 

tolerances 

[mg/kg]1)

Comments 

Pome fruit 1 Import tolerance (0.3 mg/kg based on EU-GAP) 

Peach / Apricots 2 Import tolerance (1 mg/kg based on EU-GAP) 

Cherries 5 Import tolerance (1 mg/kg based on EU-GAP) 

Plums 2 Import tolerance (2 mg/kg also based on EU-GAP)

Grapes 2 Import tolerance (1 mg/kg based on EU-GAP) 

Strawberries 1 --- 

Potatoes 0.5 Import tolerance (no EU-GAP) 

Onions 0.3 --- 

Tomatoes 2 --- 

Peppers 2 Import tolerance (2 mg/kg also based on EU-GAP) 

Aubergines 2 Extrapolated from tomatoes. 

Cucumbers 0.2 Import tolerance (0.2 mg/kg also based on EUGAP) 

Courgettes 0.2 Extrapolated from cucumbers. 

Cucurbits (inedible peel) 0.3 Import tolerance 

Flowering brassica 1 Import tolerance (1 mg/kg based on EU-GAP) 

Brussel sprouts 0.3 --- 

Head cabbage 2 Import tolerance (0.5 mg/kg based on EU-GAP) 

Leafy brassica 10 Import tolerance (2 mg/kg based on EU-GAP) 

Kohlrabi 2 --- 

Green beans 2 --- 

Hops 20 Import tolerance (10 mg/kg based on EU-GAP) 

Kidney (bovine, goat, sheep, swine) 0.02 --- 

1) Residues expressed in mg spirotetramat /kg 
- 212 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

B.7.17 References relied on 

The grey marked studies are relevant for the EU-evaluation. 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

Annex II Data and Information 

KIIA 6.1.1 /01 Schoening, R.; 

Wolters, A. 

2006 Storage stability of BYI 08330 and its 

metabolites BYI08330-enol, BYI08330-

ketohydroxy, BYI08330-mono-hydroxy and 

BYI08330-enol-glucoside in/on tomato 

(fruit), tomato (paste), potato (tuber), 

lettuce (head), climbing french bean ... 

Bayer CropScience AG, 

Report No.: MR-167/04, 

Edition Number: M-275244-01-2 

Date: 27.07.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.1.1 /02 Schoening, R.; 

Wolters, A. 

2006 Storage stability of BYI 08330 and its 

metabolites BYI08330-enol, BYI08330- 

ketohydroxy, BYI08330-mono-hydroxy and 

BYI08330-enol-glucoside in/on orange 

(juice) and prunes (fruit) for 5 months 

Bayer CropScience AG, 

Report No.: MR-06/076, 

Edition Number: M-276529-02-1 

Date: 28.08.2006, Amended: 27.06.2007 

GLP, unpublished 

Yes BCS 

KIIA 6.1.1 /04 Schoening, R.; 

Wolters, A. 

2007 Storage stability of BYI 08330 and its 

metabolites BYI08330-enol, BYI08330-

ketohydroxy, BYI08330-mono-hydroxy and 

BYI08330-enol-glucoside in/on tomato 

(fruit), tomato (paste), potato (tuber), 

lettuce (head), climbing French bean (bean 

with pod), and almond (nutmeat) for 24 

months 

Bayer CropScience AG, 

Report No.: MR-07/268, 

Edition Number: M-289421-01-2 

Date: 21.06.2007 

GLP, unpublished 

Yes BCS 

KIIA 6.2.1 /01 Haas, M.; Henk, 

F. 

2005 Metabolism of (azaspirodecenyl-3-

14C)BYI08330 in apple after spray 

application 

Bayer CropScience AG, 

Report No.: MEF-028/04, 

Edition Number: M-244827-01-3 

Date: 25.01.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.2.1 /02 Spiegel, K. 2006 Metabolism of [azaspirodecenyl-3-14C]BYI 

08330 in cotton after spray application 

Bayer CropScience AG, 

Report No.: MEF-236/04, 

Edition Number: M-269105-01-2 

Date: 03.03.2006 

GLP, unpublished 

Yes BCS 
- 213 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.2.1 /03 Haas, M.; 

Diederich, B. 

2004 Metabolism of [azaspirodecenyl-3-

14C]BYI08330 in lettuce 

Bayer CropScience AG, 

Report No.: MEF-049/04, 

Edition Number: M-242667-01-2 

Date: 30.11.2004 

GLP, unpublished 

Yes BCS 

KIIA 6.2.1 /04 Sur, R. 2005 Metabolism of [azaspirodecenyl-3-14C]BYI 

08330 in potatoes 

Bayer CropScience AG, 

Report No.: MEF-05/320, 

Edition Number: M-267707-01-2 

Date: 05.12.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.2.1 /05 Haas, M. 2004 Degradation of [azaspirodecenyl-3-

14C]BYI08330 by plant suspension cell 

cultures 

Bayer CropScience AG, 

Report No.: MEF-262/03, 

Edition Number: M-106579-01-2 

Date: 21.01.2004 

GLP, unpublished 

Yes BCS 

KIIA 6.2.2 /01 Koester, J.; 

Klempner, A. 

2006 Metabolism of [azaspirodecenyl-3-14C]BYI 

08330 in the laying hen 

Bayer CropScience AG, 

Report No.: MEF-05/273, 

Edition Number: M-268574-01-2 

Date: 31.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.2.3 /01 Koester, J.; 

Klempner, A. 

2006 [Azaspirodecenyl-3-14C]BYI 08330: 

Absorption, distribution, excretion, and 

metabolism in the lactating goat 

Bayer CropScience AG, 

Report No.: MEF-05/293, 

Edition Number: M-269256-01-2 

Date: 16.03.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.1 

/01 

Schoening, R.; 

Helfrich, P. 

2005 Determination of the residues of BYI 08330 

in/on orange after spraying of BYI 08330 

(100 OD) in the field in Italy, Portugal and 

Spain 

Bayer CropScience AG, 

Report No.: RA-2032/04, 

Report includes Trial Nos.: 

 0139-04 

 0141-04 

 0239-04 

 0240-04 

 R 2004 0139/6 

 R 2004 0141/8 

 R 2004 0239/2 

 R 2004 0240/6 

Edition Number: M-263546-01-1 

Date: 21.12.2005 

GLP, unpublished 

Yes BCS 
- 214 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.1 

/02 

Schoening, R.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on mandarin after spraying of BYI 08330 

(100 OD) in the field in Italy, Portugal and 

Spain 

Bayer CropScience AG, 

Report No.: RA-2033/04, 

Report includes Trial Nos.: 

 0142 - 04 

 0143 - 04 

 0237 - 04 

 0238 - 04 

 R 2004 0142/6 

 R 2004 0143/4 

 R 2004 0237/6 

 R 2004 0238/4 

Edition Number: M-264450-01-1 

Date: 19.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.1 

/03 

Schoening, R.; 

Wieland, K. 

2006 Determination of the residues of BYI 08330 

in/on orange after spraying of BYI 08330 

(150 OD) in the field in Portugal, Italy and 

Spain 

Bayer CropScience AG, 

Report No.: RA-2003/05, 

Report includes Trial Nos.: 

 0046-05 

 0047-05 

 0048-05 

 0049-05 

 R 2005 0046/7 

 R 2005 0047/5 

 R 2005 0048/3 

 R 2005 0049/1 

Edition Number: M-269908-01-1 

Date: 25.04.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.1 

/04 

Schoening, R.; 

Wieland, K. 

2006 Determination of the residues of BYI 08330 

in/on mandarin after spraying of BYI 08330 

(150 OD) in the field in Portugal, Spain and 

Italy 

Bayer CropScience AG, 

Report No.: RA-2002/05, 

Report includes Trial Nos.: 

 0041-05 

 0042-05 

 0043-05 

 0044-05 

 0045-05 

 R 2005 0041/6 

 R 2005 0042/4 

 R 2005 0043/2 

 R 2005 0044/0 

 R 2005 0045/9 

Edition Number: M-270179-01-1 

Date: 27.04.2006 

GLP, unpublished 

Yes BCS 
- 215 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.10 

/01 

Freitag, T.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on cherry tomato after spraying of BYI 

08330 (100 OD) in the greenhouse in Italy 

and Spain 

Bayer CropScience AG, 

Report No.: RA-2139/04, 

Report includes Trial Nos.: 

 0823 - 04 

 0824 - 04 

 0825 - 04 

 0826 - 04 

 R 2004 0823/4 

 R 2004 0824/2 

 R 2004 0825/0 

 R 2004 0826/9 

Edition Number: M-264462-01-1 

Date: 17.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.10 

/02 

Freitag, T.; 

Helfrich, P. 

2005 Determination of the residues of BYI 08330 

in/on tomato after spraying of BYI 08330 

(100 OD) in the greenhouse in Greece, 

Spain and Italy 

Bayer CropScience AG, 

Report No.: RA-2140/04, 

Report includes Trial Nos.: 

 0827-04 

 0828-04 

 0829-04 

 0830-04 

 R 2004 0827/7 

 R 2004 0828/5 

 R 2004 0830/7 

 R 2004 0929/3 

Edition Number: M-263523-01-1 

Date: 20.12.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.10 

/03 

Freitag, T.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on tomato after spraying of BYI 08330 

(100 OD) in the field in Spain, Portugal, 

Greece and Italy 

Bayer CropScience AG, 

Report No.: RA-2130/04, 

Report includes Trial Nos.: 

 0849-04 

 0850-04 

 0852-04 

 0853-04 

 R 2004 0849/8 

 R 2004 0850/1 

 R 2004 0852/8 

 R 2004 0853/6 

Edition Number: M-263566-01-1 

Date: 10.01.2006 

GLP, unpublished 

Yes BCS 
- 216 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.11 

/01 

Schoening, R.; 

Wolters, A. 

2005 Determination of the residues of BYI 08330 

in/on pepper after spraying of BYI 08330 

(100 OD) in the greenhouse in the 

Netherlands, Germany, Southern France, 

Portugal, Italy and Spain 

Bayer CropScience AG, 

Report No.: RA-2026/04, 

Report includes Trial Nos.: 

 0113-04 

 0114-04 

 0115-04 

 0116-04 

 0117-04 

 0118-04 

 0119-04 

 0120-04 

 R 2004 0113/2 

 R 2004 0114/0 

 R 2004 0115/9 

 R 2004 0116/7 

 R 2004 0117/5 

 R 2004 0118/3 

 R 2004 0119/1 

 R 2004 0120/5 

Edition Number: M-259820-01-1 

Date: 02.11.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.11 

/02 

Schoening, R.; 

Wolters, A. 

2005 Determination of the residues of BYI 08330 

in/on pepper after spraying of BYI 08330 

(100 OD) in the field in Spain, Southern 

France, Italy and Portugal 

Bayer CropScience AG, 

Report No.: RA-2027/04, 

Report includes Trial Nos.: 

 0121-04 

 0122-04 

 0124-04 

 0125-04 

 R 2004 0121/3 

 R 2004 0122/1 

 R 2004 0124/8 

 R 2004 0125/6 

Edition Number: M-260011-01-1 

Date: 07.11.2005 

GLP, unpublished 

Yes BCS 
- 217 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.11 

/03 

Schoening, R.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on pepper after spraying of BYI 08330 

(240 SC) in the greenhouse in Southern 

France, Germany, Italy and Portugal 

Bayer CropScience AG, 

Report No.: RA-2134/04, 

Report includes Trial Nos.: 

 0791-04 

 0792-04 

 0793-04 

 0794-04 

 R 2004 0791/2 

 R 2004 0792/0 

 R 2004 0793/9 

 R 2004 0794/7 

Edition Number: M-263426-01-1 

Date: 09.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.11 

/04 

Schoening, R.; 

Wolters, A. 

2006 Determination of the residues of BYI 08330 

in/on pepper after spraying of BYI 08330 

(150 OD) in the field in Italy and Portugal 

Bayer CropScience AG, 

Report No.: RA-2039/05, 

Report includes Trial Nos.: 

 0200-05 

 0202-05 

 R 2005 0200/1 

 R 2005 0202/8 

Edition Number: M-266615-01-1 

Date: 21.02.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.11 

/05 

Schoening, R.; 

Wolters, A. 

2006 Determination of the residues of BYI 08330 

in/on pepper after spraying of BYI 08330 

(048 SC) in the field in Italy and Portugal 

Bayer CropScience AG, 

Report No.: RA-2046/05, 

Report includes Trial Nos.: 

 0707-05 

 0708-05 

 R 2005 0707/0 

 R 2005 0708/9 

Edition Number: M-266682-01-1 

Date: 21.02.2006 

GLP, unpublished 

Yes BCS 
- 218 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.12 

/01 

Cavaille, C. 2005 Determination of the residues of BYI 08330 

in/on cucumber after spraying of BYI 08330 

(100 OD) in the greenhouse in Germany, 

Italy, Spain and Greece 

Bayer CropScience, CRLD, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2030/04, 

Report includes Trial Nos.: 

 0130-04 

 0131-04 

 0132-04 

 0133-04 

 0134-04 

 0135-04 

 0136-04 

 0138-04 

 R20040130/2 

 R20040131/0 

 R20040132/9 

 R20040133/7 

 R20040134/5 

 R20040136/1 

 R20040138/8 

Edition Number: M-259128-01-1 

Date: 21.10.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.12 

/02 

Cavaille, C. 2005 Determination of the residues of BYI 08330 

in/on cucumber after spraying of BYI 08330 

(100 OD) in the field in Spain and Italy 

Bayer CropScience AG, 

Report No.: RA-2028/04, 

Report includes Trial Nos.: 

 0126-04 

 0128-04 

 0129-04 

 R20040126/4 

 R20040128/0 

 R20040129/9 

Edition Number: M-259667-01-1 

Date: 02.11.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.12 

/03 

Ballesteros, C. 2006 Determination of the residues of BYI 08330 

in/on cucumber after spraying of BYI 08330 

(150 OD) in the field in Spain and Italy 

Bayer CropScience SA, Centre de 

Recherche de La Dargoire, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2043/05, 

Report includes Trial Nos.: 

 R 2005 0239/7 

 R 2005 0240/0 

 R 2005 0241/9 

 R 2005 0715/1 

Edition Number: M-268869-01-1 

Date: 03.04.2006 

GLP, unpublished 

Yes BCS 
- 219 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.13 

/01 

Cavaille, C. 2005 Determination of the residues of BYI 08330 

in/on melon after spraying of BYI 08330 

(100 OD) in the greenhouse in Italy, Spain, 

Southern France, and Portugal 

Bayer CropScience, Development - 

Residues, Operator and Concumer Safety, 

CRLD, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2128/04, 

Report includes Trial Nos.: 

 0836-04 

 0837-04 

 0838-04 

 0839-04 

 0840-04 

 0841-04 

 0881-04 

 0883-04 

 R20040836/6 

 R20040837/4 

 R20040838/2 

 R20040839/0 

 R20040840/4 

 R20040841/2 

 R20040881/1 

 R20040883/0 

Edition Number: M-259446-01-1 

Date: 27.10.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.13 

/02 

Cavaille, C. 2005 Determination of the residues of BYI 08330 

in/on melon after spraying of BYI 08330 

(100 OD) in the field in Italy, Spain and 

Greece 

Bayer CropScience, Development - 

Residues, Operator and Consumer Safety, 

CRLD, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2129/04, 

Report includes Trial Nos.: 

 0842-04 

 0843-04 

 0844-04 

 0845-04 

 R20040842/0 

 R20040843/9 

 R20040844/7 

 R20040845/5 

Edition Number: M-259449-01-1 

Date: 27.10.2005 

GLP, unpublished 

Yes BCS 
- 220 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.13 

/03 

Ballesteros, C. 2006 Determination of the residues of BYI 08330 

in/on melon after spraying of BYI 08330 

(150 OD) in the field in Greece, Spain, 

Portugal and Italy 

Bayer CropScience SA, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2042/05, 

Report includes Trial Nos.: 

 R 2005 0230/3 = 0230 - 05 

 R 2005 0231/1 = 0231 - 05 

 R 2005 0233/8 = 0233 - 05 

 R 2005 0234/6 = 0234 - 05 

 R 2005 0717/8 = 0717 - 05 

Edition Number: M-268388-02-1 

Date: 16.03.2006, Amended: 09.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.14 

/01 

Bardel, P.; 

Freitag, T. 

2005 Determination of the residues of BYI 08330 

in/on broccoli after spraying of BYI 08330 

(100 OD) in the field in Germany and 

United Kingdom 

Bayer CropScience AG, 

Report No.: RA-2022/04, 

Report includes Trial Nos.: 

 0105-04 

 0108-04 

 R 2004 0105/1 

 R 2004 0108/6 

Edition Number: M-259571-01-1 

Date: 25.10.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.14 

/02 

Zimmer, D.; 

Freitag, T. 

2005 Determination of the residues of BYI 08330 

in/on cauliflower after spraying of BYI 

08330 (100 OD) in the field in Germany 

and France 

Bayer AG, Leverkusen, Germany 

Bayer CropScience AG, 

Report No.: RA-2023/04, 

Report includes Trial Nos.: 

 0109-04 

 0110-04 

 R 2004 0109/4 

 R 2004 0110/8 

Edition Number: M-259580-01-1 

Date: 26.10.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.14 

/03 

Bardel, P.; 

Freitag, T. 

2005 Determination of the residues of BYI 08330 

in/on broccoli after spraying of BYI 08330 

(100 OD) in the field in Italy 

Bayer CropScience AG, 

Report No.: RA-2024/04, 

Report includes Trial Nos.: 

 0111-04 

 R 2004 0111/6 

Edition Number: M-259272-01-1 

Date: 21.10.2005 

GLP, unpublished 

Yes BCS 
- 221 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.14 

/04 

Zimmer, D.; 

Freitag, T. 

2005 Determination of the residues of BYI 08330 

in/on cauliflower after spraying of BYI 

08330 (100 OD) in the field in France 

Bayer CropScience AG, 

Report No.: RA-2025/04, 

Report includes Trial Nos.: 

 0112-04 

 R 2004 0112/4 

Edition Number: M-258975-01-1 

Date: 18.10.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.14 

/05 

Freitag, T.; 

Wieland, K. 

2006 Determination of the residues of BYI 08330 

in/on broccoli and cauliflower after spraying 

of BYI 08330 (150 OD) in the field in 

Germany, Northern France and United 

Kingdom 

Bayer CropScience AG, 

Report No.: RA-2062/05, 

Report includes Trial Nos.: 

 0363-05 

 0364-05 

 0365-05 

 1017-05 

 1047-05 

 R 2005 0363/6 

 R 2005 0364/4 

 R 2005 0365/2 

 R 2005 1017/9 

 R 2005 1047/0 

Edition Number: M-275226-01-1 

Date: 26.07.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.14 

/06 

Freitag, T.; 

Wieland, K. 

2006 Determination of the residues of BYI 08330 

in/on broccoli and cauliflower after spraying 

of BYI 08330 (150 OD) in the field in Italy 

and Spain 

Bayer CropScience AG, 

Report No.: RA-2063/05, 

Report includes Trial Nos.: 

 0360-05 

 0362-05 

 R 2005 0360/1 

 R 2005 0362/8 

Edition Number: M-275233-01-1 

Date: 27.07.2006 

GLP, unpublished 

Yes BCS 
- 222 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.15 

/01 

Freitag, T.; 

Wolters, A. 

2005 Determination of the residues of BYI 08330 

in/on brussels sprouts after spraying of BYI 

08330 (100 OD) in the field in Germany 

and Northern France 

Bayer CropScience AG, 

Report No.: RA-2039/04, 

Report includes Trial Nos.: 

 0160-04 

 0161-04 

 0162-04 

 0163-04 

 R 2004 0160/4 

 R 2004 0161/2 

 R 2004 0162/0 

 R 2004 0163/9 

Edition Number: M-260437-01-1 

Date: 10.11.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.15 

/02 

Freitag, T.; 

Eberhardt, R.; 

Wolters, A. 

2006 Determination of the residues of BYI 08330 

in/on brussels sprouts after spraying of BYI 

08330 (150 OD) in the field in Germany, 

Northern France and United Kingdom 

Bayer CropScience AG, 

Report No.: RA-2066/05, 

Report includes Trial Nos.: 

 0369 - 05 

 0370 - 05 

 0371 - 05 

 0372 - 05 

 R 2005 0369/5 

 R 2005 0370/9 

 R 2005 0371/7 

 R 2005 0372/5 

Edition Number: M-273238-01-1 

Date: 21.06.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.16 

/01 

Freitag, T.; 

Wolters, A. 

2005 Determination of the residues of BYI 08330 

in/on round cabbage, red cabbage and 

savoy cabbage after spraying of BYI 08330 

(100 OD) in the field in Germany, United 

Kingdom and Northern France 

Bayer CropScience AG, 

Report No.: RA-2037/04, 

Report includes Trial Nos.: 

 0152-04 

 0156-04 

 0157-04 

 R 2004 0152/3 

 R 2004 0156/6 

 R 2004 0157/4 

Edition Number: M-260141-01-1 

Date: 02.11.2005 

GLP, unpublished 

Yes BCS 
- 223 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.16 

/02 

Freitag, T.; 

Behn, U. 

2005 Determination of the residuesof BYI 08330 

in/on red cabbage and round cabbage after 

spraying of BYI 08330 (100 OD) in the field 

in Spain and Italy 

Bayer AG, Leverkusen, Germany 

Bayer CropScience AG, 

Report No.: RA-2038/04, 

Report includes Trial Nos.: 

 0158-04 

 0159-04 

 R 2004 0158/2 

 R 2004 0159/0 

Edition Number: M-260014-01-1 

Date: 07.11.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.16 

/03 

Ballesteros, 

Gateaud, L. 

2006 Determination of the residues of BYI 08330 

in/on red cabbage, round cabbage and 

Savoy cabbage after spraying of BYI 08330 

(150 OD) in the field in Northern-France 

and Germany 

Bayer CropScience SA, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2060/05, 

Report includes Trial Nos.: 

 R20050352/0=0352-05 

 R20050353/9=0353-05 

 R20050354/7=0354-05 

 R20050355/5=0355-05 

 R20050356/3=0356-05 

 R20050357/1=0357-05 

 R20050359/8=0359-05 

Edition Number: M-272557-01-1 

Date: 09.06.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.16 

/04 

Ballesteros, 

Gateaud, L. 

2006 Determination of the residues of BYI 08330 

in/on red cabbage and round cabbage after 

spraying of BYI 08330 (150 OD) in the field 

in Italy and Spain 

Bayer CropScience SA, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2061/05, 

Report includes Trial Nos.: 

 R20050350/4=0350-05 

 R20050351/2=0351-05 

Edition Number: M-272570-01-1 

Date: 12.06.2006 

GLP, unpublished 

Yes BCS 
- 224 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.17 

/01 

Freitag, T.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in/on curly kale after spraying of BYI 08330 

(100 OD) in the field in United Kingdom 

and Germany 

Bayer CropScience AG, 

Report No.: RA-2040/04, 

Report includes Trial Nos.: 

 0164-04 

 0165-04 

 R 2004 0164/7 

 R 2004 0165/5 

Edition Number: M-263745-01-1 

Date: 11.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.17 

/02 

Cavaille, C. 2006 Amendment no. 1 - Determination of the 

residues of BYI 08330 in/on curly kale after 

spraying of BYI 08330 (150 OD) in the field 

in Germany 

Bayer CropScience SA, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2064/05, 

Report includes Trial Nos.: 

 R20050367/9=0367-05 

 R20050368/7=0368-05 

Edition Number: M-272573-02-1 

Date: 12.06.2006, Amended: 20.07.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.17 

/03 

Freitag, T.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in/on chinese kale after spraying of BYI 

08330 (100 OD) in the field in southern 

France and Spain 

Bayer CropScience AG, 

Report No.: RA-2041/04, 

Report includes Trial Nos.: 

 0166 - 04 

 0167 - 04 

 R 2004 0166/3 

 R 2004 0167/1 

Edition Number: M-264301-01-1 

Date: 17.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.17 

/04 

Ballesteros, C.; 

Gateaud, L. 

2006 Determination of the residues of BYI 08330 

in/on Chinese cabbage after spraying of 

BYI 08330 (150 OD) in the field in Spain 

and Italy 

Bayer CropScience SA, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2136/05, 

Report includes Trial Nos.: 

 0709-05 

 0710-05 

 R 2005 0709/7 

 R 2005 0710/0 

Edition Number: M-273243-01-1 

Date: 23.06.2006 

GLP, unpublished 

Yes BCS 
- 225 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.18 

/01 

Freitag, T.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in/on kohlrabi after spraying of BYI 08330 

(100 OD) in the field in Germany and the 

Netherlands 

Bayer CropScience AG, 

Report No.: RA-2043/04, 

Report includes Trial Nos.: 

 0169-04 

 0170-04 

 R 2004 0169/8 

 R 2004 0170/1 

Edition Number: M-265036-01-1 

Date: 30.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.18 

/02 

Freitag, T.; 

Eberhardt R. 

2006 Determination of the residues of BYI 08330 

in/on kohlrabi after spraying of BYI 08330 

(150 OD) in the field in Germany 

Bayer CropScience AG, 

Report No.: RA-2065/05, 

Report includes Trial Nos.: 

 0373 - 05 

 0374 - 05 

 R 2005 0373/3 

 R 2005 0374/1 

Edition Number: M-272128-01-1 

Date: 31.05.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.19 

/01 

Schoening, R.; 

Wolters, A. 

2006 Determination of the residues of BYI 08330 

in/on climbing french bean after spraying of 

BYI 08330 (100 OD) in the greenhouse in 

Italy, Germany and Southern France 

Bayer CropScience AG, 

Report No.: RA-2042/04, 

Report includes Trial Nos.: 

 0172-04 

 0173-04 

 0174-04 

 0175-04 

 0176-04 

 0177-04 

 0178-04 

 0179-04 

 R 2004 0172/8 

 R 2004 0173/6 

 R 2004 0174/4 

 R 2004 0175/2 

 R 2004 0176/0 

 R 2004 0177/9 

 R 2004 0178/7 

 R 2004 0179/5 

Edition Number: M-263646-01-1 

Date: 11.01.2006 

GLP, unpublished 

Yes BCS 
- 226 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.2 

/01 

Schoening, R.; 

Wolters, A. 

2005 Determination of the residues of BYI 08330 

in/on lettuce after spraying of BYI 08330 

(100 OD) in the greenhouse in Germany, 

Southern France, Italy and Spain 

Bayer CropScience AG, 

Report No.: RA-2054/04, 

Report includes Trial Nos.: 

 0393-04 

 0394-04 

 0396-04 

 0397-04 

 0398-04 

 0399-04 

 0401-04 

 0402-04 

 R 2004 0393/3 

 R 2004 0394/1 

 R 2004 0396/8 

 R 2004 0397/6 

 R 2004 0398/4 

 R 2004 0399/2 

 R 2004 0401/8 

 R 2004 0402/6 

Edition Number: M-262616-01-1 

Date: 15.12.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.2 

/02 

Schoening, R. 2006 Determination of the residues of BYI 08330 

in/on lettuce after spraying of BYI 08330 

(150 OD) in the greenhouse in Greece, 

France, Netherlands, Portugal, Germany 

and Spain 

Bayer CropScience AG, 

Report No.: RA-2170/05, 

Report includes Trial Nos.: 

 1023 - 05 

 1024 - 05 

 1026 - 05 

 1027 - 05 

 1028 - 05 

 1029 - 05 

 1030 - 05 

 1031 - 05 

 R 2005 1023/3 

 R 2005 1024/1 

 R 2005 1026/8 

 R 2005 1027/6 

 R 2005 1028/4 

 R 2005 1029/2 

 R 2005 1030/6 

 R 2005 1031/4 

Edition Number: M-272108-01-1 

Date: 31.05.2006 

GLP, unpublished 

Yes BCS 
- 227 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.2 

/03 

Schoening, R.; 

Behn, U. 

2005 Determination of the residues of BYI 08330 

in/on lettuce after spraying of BYI 08330 

(240 SC) in the greenhosue in Germany, 

Italy and Spain 

Bayer CropScience AG, 

Report No.: RA-2113/04, 

Report includes Trial Nos.: 

 0685-04 

 0687-04 

 0688-04 

 0689-04 

 R 2004 0685/1 

 R 2004 0687/8 

 R 2004 0688/6 

 R 2004 0689/4 

Edition Number: M-261625-01-1 

Date: 15.11.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.2 

/04 

Schoening, R.; 

Wolters, A. 

2005 Determination of the Residues of BYI 

08330 in/on Lettuce after Spraying of BYI 

08330 (100 OD) in the Field in the 

Netherlands and Germany 

Bayer CropScience AG, 

Report No.: RA-2052/04, 

Report includes Trial Nos.: 

 0385-04 

 0386-04 

 0387-04 

 0388-04 

 R 2004 0385/2 

 R 2004 0386/0 

 R 2004 0387/9 

 R 2004 0388/7 

Edition Number: M-260209-01-1 

Date: 03.11.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.2 

/05 

Schoening, R.; 

Behn, U. 

2005 Determination of the residues of BYI 08330 

in/on lettuce after spraying of BYI 08330 

(100 OD) in the field in Southern France, 

Spain, Portugal and Italy 

Bayer CropScience AG, 

Report No.: RA-2053/04, 

Report includes Trial Nos.: 

 0389-04 

 0390-04 

 0391-04 

 0392-04 

 R 2004 0389/5 

 R 2004 0390/9 

 R 2004 0391/7 

 R 2004 0392/5 

Edition Number: M-260382-01-1 

Date: 08.11.2005 

GLP, unpublished 

Yes BCS 
- 228 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.20 

/01 

Schoening, R.; 

Wolters, A. 

2005 Determination of the residues of BYI 08330 

in/on potato after spraying of BYI 08330 

(100 OD) in the field in Germany, Northern 

France and United Kingdom 

Bayer CropScience AG, 

Report No.: RA-2114/04, 

Report includes Trial Nos.: 

 0690-04 

 0691-04 

 0692-04 

 0693-04 

 R 2004 0690/8 

 R 2004 0691/6 

 R 2004 0692/4 

 R 2004 0693/2 

Edition Number: M-259808-01-1 

Date: 03.11.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.20 

/02 

Schoening, R.; 

Wolters, A. 

2005 Determination of the residues of BYI 08330 

in/on potato after spraying of BYI 08330 

(100 OD) in the field in Southern France, 

Italy, Spain and Portugal 

Bayer AG, Leverkusen, Germany 

Bayer CropScience AG, 

Report No.: RA-2115/04, 

Report includes Trial Nos.: 

 0694-04 

 0695-04 

 0696-04 

 0697-04 

 R 2004 0694/0 

 R 2004 0695/9 

 R 2004 0696/7 

 R 2004 0697/5 

Edition Number: M-262622-01-1 

Date: 15.12.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.21 

/01 

Schoening, R.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on hop after spraying of BYI 08330 (100 

OD) in the field in Northern France and 

Germany 

Bayer CropScience AG, 

Report No.: RA-2036/04, 

Report includes Trial Nos.: 

 0148-04 

 0149-04 

 0150-04 

 0151-04 

 R 2004 0148/5 

 R 2004 0149/3 

 R 2004 0150/7 

 R 2004 0151/5 

Edition Number: M-265047-01-1 

Date: 27.01.2006 

GLP, unpublished 

Yes BCS 
- 229 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.21 

/02 

Schoening, R. 2006 Determination of the residues of BYI 08330 

in/on hop after spraying of BYI 08330 (150 

OD) in the field in Germany and Northern 

France 

Bayer CropScience AG, 

Report No.: RA-2108/05, 

Report includes Trial Nos.: 

 0550 - 05 

 0551 - 05 

 0552 - 05 

 0553 - 05 

 R 2005 0550/7 

 R 2005 0551/5 

 R 2005 0552/3 

 R 2005 0553/1 

Edition Number: M-272100-01-1 

Date: 19.05.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.3 

/01 

Schoening, R.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in/on apple and pear after spraying of BYI 

08330 (150 OD) in the field in United 

Kingdom and Germany 

Bayer CropScience AG, 

Report No.: RA-2012/05, 

Report includes Trial Nos.: 

 0083-05 

 0085-05 

 0086-05 

 0087-05 

 1018-05 

 R 2005 0083/1 

 R 2005 0085/8 

 R 2005 0086/6 

 R 2005 0087/4 

 R 2005 1018/7 

Edition Number: M-269314-01-1 

Date: 06.04.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.3 

/02 

Schoening, R.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on apple and pear after spraying and 

low-volume spraying of BYI 08330 (240 

SC) in the field in Germany, United 

Kingdom and Northern France 

Bayer CropScience AG, 

Report No.: RA-2138/04, 

Report includes Trial Nos.: 

 0809 - 04 

 0810 - 04 

 0811 - 04 

 0812 - 04 

 R 2004 0809/9 

 R 2004 0810/2 

 R 2004 0811/0 

 R 2004 0812/9 

Edition Number: M-264454-01-1 

Date: 18.01.2006 

GLP, unpublished 

Yes BCS 
- 230 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.3 

/03 

Schoening, R.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on apple and pear after spraying and 

low-volume spraying of BYI 08330 (100 

OD) in the field in Italy, Spain and Southern 

France 

Bayer CropScience AG, 

Report No.: RA-2137/04, 

Report includes Trial Nos.: 

 0805 - 04 

 0806 - 04 

 0807 - 04 

 0808 - 04 

 R 2004 0805/6 

 R 2004 0806/4 

 R 2004 0807/2 

 R 2004 0808/0 

Edition Number: M-264357-01-1 

Date: 18.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.3 

/04 

Schoening, R.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in/on apple and pear after spraying of BYI 

08330 (150 OD) in the field in Southern 

France and Italy 

Bayer CropScience AG, 

Report No.: RA-2015/05, 

Report includes Trial Nos.: 

 0088-05 

 0089-05 

 0090-05 

 0091-05 

 R 2005 0088/2 

 R 2005 0089/0 

 R 2005 0090/4 

 R 2005 0091/2 

Edition Number: M-268258-01-1 

Date: 16.03.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.3 

/05 

Schoening, R.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on apple and pear after spraying and 

low-volume spraying of BYI 08330 (240 

SC) in the field in Italy, Spain and Southern 

France 

Bayer CropScience AG, 

Report No.: RA-2136/04, 

Report includes Trial Nos.: 

 0800 - 04 

 0801 - 04 

 0802 - 04 

 0804 - 04 

 R 2004 0800 /5 

 R 2004 0801/3 

 R 2004 0802/1 

 R 2004 0804/8 

Edition Number: M-264397-01-1 

Date: 19.01.2006 

GLP, unpublished 

Yes BCS 
- 231 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.3 

/06 

Schoening, R.; 

Helfrich, P. 

2005 Determination of the residues of BYI 08330 

in/on apple and pear after spraying and 

low-volume spraying of BYI 08330 (100 

OD) in the field in Germany, United 

Kingdom and Northern France 

Bayer CropScience AG, 

Report No.: RA-2135/04, 

Report includes Trial Nos.: 

 0795-04 

 0796-04 

 0797-04 

 0799-04 

 R 2004 0795/5 

 R 2004 0796/3 

 R 2004 0797/1 

 R 2004 0799/8 

Edition Number: M-262625-02-2 

Date: 15.12.2005, Amended: 29.05.2007 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.4 

/01 

Schoening, R.; 

Wolters, A. 

2005 Determination of the residues of BYI 08330 

in/on peach and apricot after spraying of 

BYI 08330 (100 OD) in the field in Northern 

France and Germany 

Bayer CropScience AG, 

Report No.: RA-2126/04, 

Report includes Trial Nos.: 

 0785-04 

 0786-04 

 R 2004 0785/8 

 R 2004 0786/6 

Edition Number: M-259798-01-1 

Date: 02.11.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.4 

/02 

Schoening, R.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in/on apricot and peach after spraying of 

BYI 08330 (150 OD) in the field in 

Germany and Northern France 

Bayer CropScience AG, 

Report No.: RA-2006/05, 

Report includes Trial Nos.: 

 0059-05 

 0060-05 

 0061-05 

 R 2005 0059/9 

 R 2005 0060/2 

 R 2005 0061/0 

Edition Number: M-268003-01-1 

Date: 14.03.2006 

GLP, unpublished 

Yes BCS 
- 232 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.4 

/03 

Schoening, R.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on peach and apricot after spraying of 

BYI 08330 (100 OD) in the field in Spain 

and Italy 

Bayer CropScience AG, 

Report No.: RA-2127/04, 

Report includes Trial Nos.: 

 0787-04 

 0788-04 

 0789-04 

 0790-04 

 R 2004 0787/4 

 R 2004 0788/2 

 R 2004 0789/0 

 R 2004 0790/4 

Edition Number: M-263878-01-1 

Date: 11.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.4 

/04 

Schoening, R.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in/on apricot and peach after spraying of 

BYI 08330 (150 OD) in the field in Portugal, 

Spain, Greece, Southern France and Italy 

Bayer CropScience AG, 

Report No.: RA-2007/05, 

Report includes Trial Nos.: 

 0062-05 

 0063-05 

 0064-05 

 0065-05 

 0066-05 

 R 2005 0062/9 

 R 2005 0063/7 

 R 2005 0064/5 

 R 2005 0065/3 

 R 2005 0066/1 

Edition Number: M-268094-01-1 

Date: 14.03.2006 

GLP, unpublished 

Yes B BCS 

KIIA 6.3.1.5 

/01 

Schoening, R.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on plum after spraying of BYI 08330 (100 

OD) in the field in Germany, Northern 

France and United Kingdom 

Bayer CropScience AG, 

Report No.: RA-2124/04, 

Report includes Trial Nos.: 

 0774-04 

 0775-04 

 0776-04 

 0777-04 

 R 2004 0774/2 

 R 2004 0775/0 

 R 2004 0776/9 

 R 2004 0777/7 

Edition Number: M-263688-01-1 

Date: 10.01.2006 

GLP, unpublished 

Yes Bayer 

CropScience 
- 233 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.5 

/02 

Schoening, R. 2006 Determination of the residues of BYI 08330 

in/on plum after spraying of BYI 08330 (150 

OD) in the field in United Kingdom, 

Northern France and Germany 

Bayer CropScience AG, 

Report No.: RA-2004/05, 

Report includes Trial Nos.: 

 0050-05 

 0051-05 

 0052-05 

 0054-05 

 R 2005 0050/5 

 R 2005 0051/3 

 R 2005 0052/1 

 R 2005 0054/8 

Edition Number: M-266052-01-1 

Date: 09.02.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.5 

/03 

Schoening, R.; 

Wolters, A. 

2005 Determination of the residues of BYI 08330 

in/on plum after low-volume spraying and 

spraying of BYI 08330 (100 OD) in the field 

in Southern France and Italy 

Bayer CropScience AG, 

Report No.: RA-2125/04, 

Report includes Trial Nos.: 

 0778-04 

 0779-04 

 R 2004 0778/5 

 R 2004 0779/3 

Edition Number: M-262626-01-1 

Date: 15.12.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.5 

/04 

Schoening, R. 2006 Determination of the residues of BYI 08330 

in/on plum after spraying of BYI 08330 (150 

OD) in the field in Italy and Spain 

Bayer CropScience AG, 

Report No.: RA-2005/05, 

Report includes Trial Nos.: 

 0055-05 

 0058-05 

 R 2005 0055/6 

 R 2005 0058/0 

Edition Number: M-266062-01-1 

Date: 07.02.2006 

GLP, unpublished 

Yes BCS 
- 234 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.6 

/01 

Schoening, R.; 

Behn, U.; 

Wolters, A. 

2006 Determination of the residues of BYI 08330 

in/on sweet cherry and sour cherry after 

spraying of BYI 08330 (100 OD) in the field 

in Northern France and Germany 

Bayer CropScience AG, 

Report No.: RA-2119/04, 

Report includes Trial Nos.: 

 0718-04 

 0720-04 

 0721-04 

 0723-04 

 R 2004 0718/1 

 R 2004 0720/3 

 R 2004 0721/1 

 R 2004 0723/8 

Edition Number: M-263879-01-1 

Date: 12.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.6 

/02 

Schoening, R.; 

Raecker, T. 

2006 Determination of the residues of BYI 08330 

in/on sweet cherry and sour cherry after 

spraying of BYI 08330 (150 OD) in the field 

in Germany and Northern France 

Bayer CropScience AG, 

Report No.: RA-2008/05, 

Report includes Trial Nos.: 

 0068-05 

 0071-05 

 0072-05 

 R 2005 0068/8 

 R 2005 0071/8 

 R 2005 0072/6 

Edition Number: M-267524-01-1 

Date: 06.03.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.6 

/03 

Schoening, R.; 

Wolters, A. 

2005 Determination of the resideus of BYI 08330 

in/on sweet cherry after spraying of BYI 

08330 (100 OD) in the field in Italy and 

Southern France 

Bayer CropScience AG, 

Report No.: RA-2118/04, 

Report includes Trial Nos.: 

 0716-04 

 0717-04 

 R 2004 0716/5 

 R 2004 0717/3 

Edition Number: M-260405-01-1 

Date: 08.11.2005 

GLP, unpublished 

Yes BCS 
- 235 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.6 

/04 

Schoening, R.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in/on sweet cherry after spraying of BYI 

08330 (150 OD) in the field in Italy and 

Spain 

Bayer CropScience AG, 

Report No.: RA-2009/05, 

Report includes Trial Nos.: 

 0073-05 

 0074-05 

 R 2005 0073/4 

 R 2005 0074/2 

Edition Number: M-267488-01-1 

Date: 06.03.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.7 

/01 

Schoening, R.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in/on grape and table grape after spraying 

and low-volume spraying of BYI 08330 

(100 OD) in the field in Italy, Greece, Spain 

and Southern France 

Bayer CropScience AG, 

Report No.: RA-2049/04, 

Report includes Trial Nos.: 

 0196-04 

 0197-04 

 0198-04 

 0201-04 

 0202-04 

 0203-04 

 R 2004 0196/5 

 R 2004 0197/3 

 R 2004 0198/1 

 R 2004 0201/5 

 R 2004 0202/3 

 R 2004 0203/1 

Edition Number: M-263864-01-1 

Date: 12.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.7 

/02 

Ballesteros, C.; 

Gateaud, L. 

2006 Determination of the residues of BYI 08330 

in/on grape after spraying of BYI 08330 

(150 OD) in the field in Spain and Italy 

Bayer CropScience SA, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2034/05, 

Report includes Trial Nos.: 

 R20050157/9=0157-05 

 R20050158/7=0158-05 

Edition Number: M-270088-01-1 

Date: 02.05.2006 

GLP, unpublished 

Yes BCS 
- 236 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.7 

/03 

Ballesteros, C.; 

Gateaud, L. 

2006 Determination of the residues of BYI 08330 

in/on grape after low-volume spraying and 

spraying of BYI 08330 (048 SC) in the field 

in Southern-France and Italy 

Bayer CropScience SA, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2036/05, 

Report includes Trial Nos.: 

 0161-05 

 0162-05 

 R20050161/7 

 R20050162/5 

Edition Number: M-273708-01-1 

Date: 24.04.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.8 

/01 

Freitag, T.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in/on strawberry after spraying of BYI 

08330 (100 OD) in the greenhouse in 

Germany and France 

Bayer CropScience AG, 

Report No.: RA-2122/04, 

Report includes Trial Nos.: 

 0726-04 

 0765-04 

 0766-04 

 0768-04 

 0769-04 

 0771-04 

 0772-04 

 0773-04 

 R 2004 0726/2 

 R 2004 0765/3 

 R 2004 0766/1 

 R 2004 0768/8 

 R 2004 0769/6 

 R 2004 0771/8 

 R 2004 0772/6 

 R 2004 0773/4 

Edition Number: M-263736-01-1 

Date: 11.01.2006 

GLP, unpublished 

Yes BCS 
- 237 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.8 

/02 

Freitag, T.; 

Helfrich, P. 

2005 Determination of the residues of BYI 08330 

in/on strawberry after spraying of BYI 

08330 (100 OD) in the field in Germany 

and Northern France 

Bayer CropScience AG, 

Report No.: RA-2120/04, 

Report includes Trial Nos.: 

 0724-04 

 0759-04 

 0760-04 

 0761-04 

 R 2004 0724/6 

 R 2004 0759/9 

 R 2004 0760/2 

 R 2004 0761/0 

Edition Number: M-262423-02-1 

Date: 14.12.2005, Amended: 18.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.8 

/03 

Freitag, T.; 

Helfrich, P. 

2005 Determination of the residues of BYI 08330 

in/on strawberry after spraying of BYI 

08330 (100 OD) in the field in Italy, Spain 

and Southern France 

Bayer CropScience AG, 

Report No.: RA-2121/04, 

Report includes Trial Nos.: 

 0725-04 

 0762-04 

 0763-04 

 0764-04 

 R 2004 0725/4 

 R 2004 0762/9 

 R 2004 0763/7 

 R 2004 0764/5 

Edition Number: M-262418-02-1 

Date: 14.12.2005, Amended: 18.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.9 

/01 

Cavaille, C. 2005 Determination of the residues of BYI 08330 

in/on onion after spraying of BYI 08330 

(100 OD) in the field in Germany and 

Northern France 

Bayer CropScience S.A., Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2131/04, 

Report includes Trial Nos.: 

 0854-04 

 0855-04 

 0856-04 

 0857-04 

 R20040854/4 

 R20040855/2 

 R20040856/0 

 R20040857/9 

Edition Number: M-259115-01-1 

Date: 21.10.2005 

GLP, unpublished 

Yes BCS 
- 238 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.1.9 

/02 

Ballesteros, C.; 

Gateaud, L. 

2006 Determination of the residues of BYI 08330 

in/on onion after spraying of BYI 08330 

(150 OD) in the field in United Kingdom, 

Northern-France and Germany 

Bayer CropScience SA, Centre de 

Recherche de La Dargoire, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2040/05, 

Report includes Trial Nos.: 

 R 2005 0212/5 

 R 2005 0214/1 

 R 2005 0216/8 

 R 2005 0217/6 

Edition Number: M-269474-01-1 

Date: 14.04.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.9 

/03 

Cavaille, C. 2005 Determination of the residues of BYI 08330 

in/on onion after spraying of BYI 08330 

(100 OD) in the field in Southern France, 

Greece, Italy and Spain 

Bayer CropScience, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2132/04, 

Report includes Trial Nos.: 

 0858-04 

 0859-04 

 0860-04 

 0861-04 

 R20040858/7 

 R20040859/5 

 R20040860/9 

 R20040861/7 

Edition Number: M-259663-01-1 

Date: 02.11.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.3.1.9 

/04 

Ballesteros, C.; 

Gateaud, L. 

2006 Determination of the residues of BYI 08330 

in/on onion after spraying of BYI 08330 

(150 OD) in the field in Italy, Spain and 

Southern-France 

Bayer CropScience SA, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-2041/05, 

Report includes Trial Nos.: 

 R20050225/7=0225-05 

 R20050226/5=0226-05 

 R20050227/3=0227-05 

 R20050228/1=0228-05 

Edition Number: M-269869-01-1 

Date: 24.04.2006 

GLP, unpublished 

Yes BCS 
- 239 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.2.1 

/01 

Freeseman, P. 

L. 

2006 BYI08330 150 OD and BYI08330 240 SC - 

Magnitude of the residue in/on brassica 

leafy vegetables (crop subgroup 5A, head 

and stern brassica, and 5B, leafy brassica 

greens) including residue reduction 

information 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY003, 

Edition Number: M-277100-01-1 

Date: 31.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.2.10 

/01 

Mackie, S. J. 

W.; Harbin, A. 

M. 

2006 BYI08330 150 OD and BYI08330 240 SC - 

Magnitude of the residue on stone fruit 

(crop group 12 - including residue reduction 

samples) 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY001, 

Edition Number: M-277063-01-1 

Date: 31.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.2.11 

/01 

Rupprecht, J. K. 2006 BYI08330 150 OD and BYI08330 240 SC - 

Magnitude of the residue on tree nuts (crop 

group 14) 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY010, 

Edition Number: M-277323-01-1 

Date: 01.09.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.2.2 

/01 

Duah, F. K. 2006 BYI08330 150 OD and BYI08330 240 SC -

Magnitude of the residue in/on curcubit 

vegetables (crop group 9, including residue 

reduction information) 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY007, 

Edition Number: M-277110-01-1 

Date: 31.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.2.3 

/01 

Mackie, S. J. W. 2006 BYI08330 150 OD and BYI08330 240 SC - 

Magnitude of the residue on fruiting 

vegetables (crop group 8 - tomato, bell 

pepper, non-bell pepper) (including residue 

reduction information) 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY006, 

Edition Number: M-277197-01-1 

Date: 31.08.2006 

GLP, unpublished 

Yes BCS 
- 240 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.3.2.4 

/01 

Fischer, D. R. 2006 BYI08330 150 OD and BYI08330 240 SC - 

Magnitude of the residue in/on leafy 

vegetables 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY002, 

Edition Number: M-277098-01-1 

Date: 31.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.2.5 

/01 

Moiser, D. G. 2006 BYI08330 150 OD and BYI08330 240 SC - 

Magnitude of the residue on potato 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY028, 

Edition Number: M-277033-01-1 

Date: 25.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.2.6 

/01 

Beedle, E. C. 2006 BYI08330 150 OD and BYI08330 240 SC - 

Magnitude of the residue on citrus (crop 

group 10, citrus fruits; includes residue 

reduction information) 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY008, 

Edition Number: M-277116-01-1 

Date: 31.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.2.7 

/01 

Mosier, D. G. 2006 BYI08330 150 OD and BYI08330 240 SC - 

Magnitude of the residue in/on grapes 

Englar Food Laboratories Inc., Moses 

Lake, WA, USA 

Bayer CropScience AG, 

Report No.: RAFNY011, 

Edition Number: M-277324-01-1 

Date: 06.09.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.2.8 

/01 

Harbin, A. M. 2006 BYI08330 150 OD and BYI08330 240 SC - 

Magnitude of the residue on hops 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY022, 

Edition Number: M-277130-01-1 

Date: 31.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.3.2.9 

/01 

Krolski, M. E. 2006 BYI08330 150 OD and BYI08330 240 SC - 

Magnitude of the residue on pome fruit 

(apple and pear) 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY009, 

Edition Number: M-277124-01-1 

Date: 01.09.2006 

GLP, unpublished 

Yes BCS 
- 241 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.4.1 /01 Lenz, C. A. 2006 BYI08330 - request for waiver of the 

requirements for poultry feeding study and 

analytical method for the determination of 

BYI08330 residues in poultry meat and 

eggs 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNPO11, 

Edition Number: M-276816-01-1 

Date: 25.07.2006 

Non GLP, unpublished 

Yes BCS 

KIIA 6.4.2 /01 Mackie, S. J. W. 2006 BYI08330 150 OD - Magnitude of the 

residue lactating cows 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNX014, 

Edition Number: M-276834-01-1 

Date: 24.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.1 /01 Koch, B.; Sur, 

R. 

2005 BYI 08330: Aqueous hydrolysis under 

conditions of processing studies 

Bayer CropScience AG, 

Report No.: MEF-04/562, 

Edition Number: M-269158-02-1 

Date: 27.09.2005, Amended: 05.04.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.1 /02 Koch, B.; Sur, 

R. 

2006 BYI 08330-enol: Aqueous hydrolysis under 

conditions of processing studies 

Bayer CropScience AG, 

Report No.: MEF-05/227, 

Edition Number: M-267011-01-1 

Date: 11.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.1 /03 Koch, B.; Sur, 

R. 

2005 BYI 08330-enol-glucoside: Aqueous 

hydrolysis under conditions of processing 

studies 

Bayer CropScience AG, 

Report No.: MEF-05/274, 

Edition Number: M-266907-01-1 

Date: 16.12.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.5.1 /04 Koch, B.; Sur, 

R. 

2006 BYI 08330-keto-hydroxy: Aqueous 

hydrolysis under conditions of processing 

studies 

Bayer CropScience AG, 

Report No.: MEF-05/409, 

Edition Number: M-267024-01-1 

Date: 11.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.1 /05 Koch, B.; Sur, 

R. 

2006 BYI 08330-mono-hydroxy: Aqueous 

hydrolysis under conditions of processing 

studies 

Bayer CropScience AG, 

Report No.: MEF-05/418, 

Edition Number: M-267165-01-1 

Date: 11.01.2006 

GLP, unpublished 

Yes BCS 
- 242 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.5.3.1 

/01 

Schoening, R.; 

Helfrich, P. 

2005 Determination of the residues of BYI 08330 

in/on orange fruit and the processed 

fractions (pulp; peel; raw juice; juice; 

pomace, wet; washings; fruit, washed; 

marmalade; peel, washed; fruit, peeled; 

strain, rest; peel, dried; pomace,....... 

Bayer CropScience AG, 

Report No.: RA-3032/04, 

Report includes Trial Nos.: 

 0139-04 

 0141-04 

 0239-04 

 0240-04 

 R 2004 0139/6 

 R 2004 0141/8 

 R 2004 0239/2 

 R 2004 0240/6 

Edition Number: M-263630-01-1 

Date: 21.12.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.5.3.2 

/01 

Schoening, R.; 

Helfrich, P. 

2005 Determination of the residues of BYI 08330 

in/on apple fruit and the processed 

fractions (fruit, washed; washings; strain 

rest; raw sauce; sauce; raw juice; juice; 

pomace, dried) after spraying of BYI 08330 

(100 OD) in the field in......... 

Bayer CropScience AG, 

Report No.: RA-3135/04, 

Report includes Trial Nos.: 

 0795-04 

 0797-04 

 R 2004 0795/5 

 R 2004 0797/1 

Edition Number: M-262624-02-1 

Date: 15.12.2005, Amended: 12.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.3.2 

/02 

Schoening, R.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on apple fruit and the processed 

fractions (fruit, washed; washings; strain 

rest; raw sauce; sauce; raw juice; juice; 

etc.) after spraying of BYI 08330 (100 OD) 

in the field in Italy and Spain 

Bayer CropScience AG, 

Report No.: RA-3137/04, 

Report includes Trial Nos.: 

 0805 - 04 

 0807 - 04 

 R 2004 0805/6 

 R 2004 0807/2 

Edition Number: M-264335-01-1 

Date: 18.01.2006 

GLP, unpublished 

Yes BCS 
- 243 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.5.3.3 

/01 

Schoening, R.; 

Billian, P:; 

Behn, U.; 

Wolters, A. 

2006 Determination of the residues of BYI 08330 

in/on sweet cherry fruit and the processed 

fractions (fruit, washed; washings; fruit, 

depitted; preserve) and sour cherry fruit 

and the processed fractions (fruit, washed; 

washings; fruit,......... 

Bayer CropScience AG, 

Report No.: RA-3119/04, 

Report includes Trial Nos.: 

 0718-04 

 0720-04 

 0721-04 

 0723-04 

 R 2004 0718/1 

 R 2004 0720/3 

 R 2004 0721/1 

 R 2004 0723/8 

Edition Number: M-263882-01-1 

Date: 12.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.3.4 

/01 

Ballesteros, C.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in the processed fractions of grape, bunch 

of grapes for processing (raisin waste; 

washings; raisin) after spraying of BYI 

08330 (150 OD) in the field in Spain and 

Italy 

Bayer CropScience SA, Lyon, France 

Bayer CropScience AG, 

Report No.: RA-3034/05, 

Report includes Trial Nos.: 

 R20050157/9=0157-05 

 R20050158/7=0158-05 

Edition Number: M-271371-02-1 

Date: 16.05.2006, Amended: 21.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.3.4 

/02 

Schoening, R.; 

Wolters, A. 

2006 Determination of the residues of BYI 08330 

in/on grape (bunch of grapes) and the 

processed fractions (pomace, grape; must; 

wine) after spraying of BYI 08330 (100 OD) 

in the field in Germany 

Bayer CropScience AG, 

Report No.: RA-3048/04, 

Report includes Trial Nos.: 

 0192-04 

 0193-04 

 R 2004 0192/2 

 R 2004 0193/0 

Edition Number: M-264728-01-1 

Date: 26.01.2006 

GLP, unpublished 

Yes BCS 
- 244 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.5.3.4 

/03 

Schoening, R.; 

Eberhardt, R. 

2006 Determination of the residues of BYI 08330 

in/on grape bunch of grapes and the 

processed fractions (pomace, grape; must; 

wine) after spraying of BYI 08330 (100 OD) 

in the field in Italy 

Bayer CropScience AG, 

Report No.: RA-3049/04, 

Report includes Trial Nos.: 

 0196-04 

 0197-04 

 R 2004 0196/5 

 R 2004 0197/3 

Edition Number: M-263874-02-1 

Date: 12.01.2006, Amended: 06.03.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.3.5 

/01 

Freitag, T.; 

Helfrich, P. 

2005 Determination of the residues of BYI 08330 

in/on tomato fruit and the processed 

fractions (washings; fruit, peeled; raw juice; 

juice; strain rest; preserve; puree; fruit, 

washed; raw puree; peel, washed; peeling 

water) after spraying....... 

Bayer CropScience AG, 

Report No.: RA-3140/04, 

Report includes Trial Nos.: 

 0827-04 

 0828-04 

 0829-04 

 0830-04 

 R 2004 0827/7 

 R 2004 0828/5 

 R 2004 0829/3 

 R 2004 0830/7 

Edition Number: M-263490-01-1 

Date: 20.12.2005 

GLP, unpublished 

Yes BCS 

KIIA 6.5.3.6 

/01 

Schoening, R.; 

Billian, P.; 

Wolters, A. 

2006 Determination of the residues of BYI 08330 

in/on climbing french bean (bean with pod) 

and the processed fractions (washings; 

cooking water; bean, cooked; bean with 

pod, washed) after spraying of BYI 08330 

(100 OD) in the greenhouse........ 

Bayer CropScience AG, 

Report No.: RA-3042/04, 

Report includes Trial Nos.: 

 0172-04 

 0173-04 

 0174-04 

 0175-04 

 R 2004 0172/8 

 R 2004 0173/6 

 R 2004 0174/4 

 R 2004 0175/2 

Edition Number: M-263683-01-1 

Date: 11.01.2006 

GLP, unpublished 

Yes BCS 
- 245 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.5.3.7 

/01 

Schoening, R.; 

Billian, P.; 

Helfrich, P. 

2006 Determination of the residues of BYI 08330 

in/on hop cone, green, for processing and 

the processed fractions (cone, kiln-dried; 

beer; hops draff; brewer’s yeast; brewer’s 

malt) after spraying of BYI 08330 (100 OD) 

in the field in........ 

Bayer CropScience AG, 

Report No.: RA-3036/04, 

Report includes Trial Nos.: 

 0148-04 

 0149-04 

 0150-04 

 0151-04 

 R 2004 0148/5 

 R 2004 0149/3 

 R 2004 0150/7 

 R 2004 0151/5 

Edition Number: M-265067-01-2 

Date: 27.01.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.4.1 

/01 

Mackie, S. J. W. 2006 BYI08330 150 OD - Magnitude of the 

residue on apple processed commodities 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY014, 

Edition Number: M-276832-01-1 

Date: 24.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.4.2 

/01 

Lenz, C. A. 2006 Amended report - BYI08330 150 OD - 

Magnitude of the residue on citrus 

processed commodities 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY016, 

Edition Number: M-277028-01-1 

Date: 29.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.4.2 

/02 

Krolski, M. E. 2006 BYI08330 100 OD - Reduction of the

residue in grapefruit from commercial 

washing, waxing, and packing procedures 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFN042, 

Edition Number: M-276675-01-1 

Date: 08.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.4.3 

/01 

Mosier, D. G. 2006 BYI08330 150 OD - Magnitude of the 

residue in/on grapes processed 

commodities 

Englar Food Laboratories Inc., Moses 

Lake, WA, USA 

Bayer CropScience AG, 

Report No.: RAFNY015, 

Edition Number: M-277287-01-1 

Date: 06.09.2006 

GLP, unpublished 

Yes BCS 
- 246 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex point/ 

reference 

number 

Author(s) Year 

Title 

Source (where different from company)

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N-R/NR 

Owner 

KIIA 6.5.4.4 

/01 

Mackie, S. J. W. 2006 BYI08330 150 OD - Magnitude of the 

residue on plum processed commodities 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY018, 

Edition Number: M-276380-01-1 

Date: 03.02.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.4.5 

/01 

Lenz, C. A. 2006 BYI08330 150 OD - Magnitude of the 

residue on potato processed commodities 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY020, 

Edition Number: M-276828-01-1 

Date: 24.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.5.4.6 

/01 

Mackie, S. J. W. 2006 BYI08330 100 OD - Magnitude of the 

residue on tomato processed commodities 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY013, 

Edition Number: M-277034-01-1 

Date: 24.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.6.2 /01 Sur, R.; Spiegel, 

K. 

2006 Metabolism of [azaspirodecenyl-3-14C]BYI 

08330 in confined rotational crops 

Bayer CropScience AG, 

Report No.: MEF-05/288, 

Edition Number: M-269589-02-2 

Date: 22.03.2006, Amended: 26.09.2006 

GLP, unpublished 

Yes BCS 

KIIA 6.6.3 /01 Lemke, V. J. 2006 BYI08330 150 OD and BYI08330 240 SC - 

Magnitude of the residue in field rotational 

crops (limited) 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNY019, 

Edition Number: M-277284-01-1 

Date: 01.09.2006 

GLP, unpublished 

Yes BCS 

Annex III Data and Information 

--- 
- 247 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I a: Summary of trial information – citrus fruits 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330

monoh

ydroxy 

BYI 

08330 

enolGlc 

Total as 

BYI 

08330 

PHI 

[days] Remarks 

RA-2032/04 R 2004 0139/6 I-95044 Mineo, Italy 

Oranges / Tarocco Gallo 

1. 01.01.1996 2. 20.05.2004 3. 01-31.03.2005 

0.2112 0.2112 

2200 2200 

0.010 0.010 

27.12.2004 17.01.2005 

BBCH 87 Fruit 

Fruit Fruit Fruit Pulp Peel Fruit Pulp Peel Fruit Pulp Peel 

0.01 0.12 0.03 0.02 

<0.01 

0.05 0.02 

<0.01 

0.03 

<0.01 <0.01 

0.01 

0.012 0.012 0.012 0.012 

<0.012 

0.058 0.012 

<0.012 

0.037 

<0.012 <0.012 

0.027 

0.012 0.012 0.012 0.012 

<0.012 

0.030 0.012 

<0.012 

0.026 

<0.012 <0.012 

0.024 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 

0.008 

<0.008 <0.008 

0.008 

<0.008 <0.008 

0.008 

0.054 0.164 0.074 0.064 0.054 0.158 0.064 0.054 0.113 0.054 0.054 0.081 

0* 

0 7 

14 14 14 21 21 21 28 28 28 

formulation: 100 OD 

RA-2032/04 R 2004 0141/8 I-95100 Catania, Italy 

Oranges / Tarocco Gallo 

1. 1995 2. 15.04.2004 3. 01.01 – 28.02.2005 

0.2300 0.2300 

2400 2400 

0.010 0.010 

06.12.2004 27.12.2004 

BBCH 88 Fruit 

Fruit Fruit Fruit Pulp Peel Fruit Pulp Peel 

<0.01 

0.11 0.02 0.02 

<0.01 

0.02 0.01 

<0.01 

0.01 

0.012 0.018 0.017 0.014 

<0.012 

0.059 0.012 

<0.012 

0.025 

0.012 0.012 0.012 0.012 

<0.012 

0.018 0.012 

<0.012 

0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 

0.008 

<0.008 <0.008 

0.008 

0.054 

0.16 

0.069 0.066 0.054 0.117 0.054 0.054 0.067 

0* 

0 

14 21 21 21 28 28 28 

formulation: 100 OD 

RA-2032/04 R 2004 0239/2 P/2950 Palmela, Portugal 

Oranges / Dalmau 

1. 15.03.1980 2. 15.03.2004 3. 01.12.2004 - 15.01.2005 

0.2880 0.2880 

3000 3000 

0.010 0.010 

26.10.2004 16.11.2004 

BBCH 83 Fruit 

Fruit Fruit Fruit Pulp Peel Fruit Pulp Peel Fruit Pulp Peel 

<0.01 

0.13 0.13 0.04 

<0.01 

0.04 0.02 

<0.01 

0.02 0.01 

<0.01 

0.01 

<0.012 

0.023 0.044 0.041 0.015 

0.11 

0.031 

<0.012 

0.049 0.033 0.015 0.030 

<0.012 <0.012 

0.014 0.013 

<0.012 

0.032 0.013 

<0.012 

0.026 0.013 

<0.012 

0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 

0.008 

<0.008 

0.008 0.008 

<0.008 

0.008 0.008 

<0.008 

0.008 

0.054 0.185 0.208 0.114 0.057 0.202 0.084 0.054 0.115 0.076 0.057 0.072 

0* 

0 7 

14 14 14 21 21 21 27 27 27 

formulation: 100 OD 
- 248 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330

monoh

ydroxy 

BYI 

08330 

enolGlc 

Total as 

BYI 

08330 

PHI 

[days] Remarks 

RA-2032/04 R 2004 0240/6 E-46450 Benifaió, Spain 

Oranges / Navelina 

1. 20.03.1984 2. 10.04.2004 3. 15.10.-30.11.2004 

0.2880 0.2880 

3000 3000 

0.010 0.010 

27.09.2004 18.10.2004 

BBCH 81 Fruit 

Fruit Fruit Fruit Pulp Peel Fruit Pulp Peel 

0.07 0.14 0.10 0.08 

<0.01 

0.14 0.05 

<0.01 

0.14 

0.052 0.062 0.090 0.078 0.063 

0.28 

0.064 0,056 

0.20 

<0.012 

0.012 0.015 0.012 

<0.012 

0.035 0.012 

<0.012 

0.033 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.011 0.012 0.016 0,016 0.008 0.054 0,017 0.008 0.052 

0.157 0.238 0.233 0.198 0.105 0.521 0.155 0.098 0.437 

0* 

0 

15 21 21 21 28 28 28 

formulation: 100 OD 

RA-2003/05 R 2005 0046/7 P-2950 Palmela, Portugal 

Orange / Dalmau 

1. 15.03.1980 2. 25.03.2005 3. 05.12.2005 - 15.01.2006 

0.2880 0.2880 

3000 3000 

0.010 0.010 

25.10.2005 15.11.2005 

BBCH 89 Fruit 

Fruit Pulp Peel Fruit Pulp Peel Fruit Pulp Peel

0.10 0.01 

<0.01 

0.02 

<0.01 <0.01 

0.01 0.02 

<0.01 

0.01

0.020 0.015 

<0.012 

0.031 

<0.012 <0.012 

0.032 0.012 

<0.012 

0.029

0.012 0.012 

<0.012 

0.016 

<0.012 <0.012 

0.015 0.012 

<0.012 

0.012

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012

<0.008 <0.008 <0.008 

0.008 

<0.008 <0.008 

0.008 0.008 

<0.008 

0.008

0.152 0.057 0.054 0.087 0.054 0.054 0.077 0.064 0.054 0.071

0 

14 14 14 21 21 21 28 28 28

formulation: 150 OD 

RA-2003/05 R 2005 0047/5 I-96013 Carlentini, Italy 

Orange / Tarocco Nucellare 

1. 1980 2. 15.04.2005 3. 01.01. - 28.02.2006 

0.2880 0.2880 

3000 3000 

0.010 0.010 

15.12.2005 04.01.2006 

BBCH 85 Fruit 

Fruit Pulp Peel Fruit Pulp Peel Fruit Pulp Peel 

0.20 0.01 

<0.01 

0.03 0.02 

<0.01 

0.05 

<0.01 <0.01 

0.02 

0.013 0.012 

<0.012 

0.044 0.012 

<0.012 

0.044 

<0.012 <0.012 

0.030 

0.012 

<0.012 <0.012 

0.016 0.012 

<0.012 

0.017 

<0.012 <0.012 

0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 

0.008 

<0.008 <0.008 

0.008 

<0.008 <0.008 

0.008 

0.245 0.054 0.054 

0.11 

0.064 0.054 0.131 0.054 0.054 0.082 

0 

14

141421 21 21 28 28 28 

formulation: 150 OD 

RA-2003/05 R 2005 0048/3 E-46400 Cullera, Spain 

Orange /Navelina 

1. 25.03.1995 2. 05.03.2005 3. 10.12.2005 

0.2880 0.2880 

3000 3000 

0.010 0.010 

05.10.2005 26.10.2005 

BBCH 81 Fruit 

Fruit Fruit Fruit Pulp Peel Fruit 

0.02 0.10 0.06 0.05 

<0.01 

0.21 0.02 

0.036 0.047 0.049 0.039 0.034 

0.20 

0.038 

0.012 0.012 0.024 0.013 

<0.012 

0.069 0.013 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.008 0.023 0.008 

0.088 0.179 0.153 0.122 0.076 0.514 0.091 

0* 

0 7 

14 14 14 21 

formulation: 150 OD 
- 249 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330

monoh

ydroxy 

BYI 

08330 

enolGlc 

Total as 

BYI 

08330 

PHI 

[days] Remarks 

Pulp Peel Fruit Pulp Peel 

<0.01 

0.04 0.01 

<0.01 

0.01 

0.025 0.098 0.032 0.022 0.072 

<0.012 

0.044 0.012 

<0.012 

0.027 

<0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.016 0.008 0.008 0.014 

0.067 

0.21 

0.074 0.064 0.135 

21 21 28 28 28 

RA-2003/05 R 2005 0049/1 I-95100 Catania, Italy 

Orange Tarocco Galici 

1. 1995 2. 15.04.2005 3. 01.01. - 28.02.2006 

0.2592 0.2592 

2700 2700 

0.010 0.010 

15.12.2005 04.01.2006 

BBCH 85 Fruit 

Fruit Fruit Fruit Pulp Peel Fruit Pulp Peel Fruit Pulp Peel 

0.04 0.11 0.04 0.03 

<0.01 

0.06 0.02 

<0.01 

0.05 0.02 

<0.01 

0.04 

0.012 0.012 0.014 0.015 

<0.012 

0.090 0.016 

<0.012 

0.059 0.013 

<0.012 

0.065 

0.013 0.012 0.012 0.012 

<0.012 

0.042 0.012 

<0.012 

0.029 0.012 

<0.012 

0.035 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 

0.008 

<0.008 <0.008 

0.008 

<0.008 <0.008 

0.008 

0.085 0.154 0.086 0.077 0.054 0.212 0.068 0.054 0.158 0.065 0.054 

0.16 

0* 

0 7 

14 14 14 21 21 21 28 28 28 

formulation: 150 OD 

RA-2033/04 R 2004 0142/6 I-Misterbianco, Italy 

Manderin / Clementine Nules 

1. 1985 2. 15.04.2004 3. 01.11.-30.12.2004 

0.211 0.211 

2200 2200 

0.010 0.010 

19.10.2004 09.11.2004 

BBCH 81 Fruit 

Fruit Fruit Fruit Pulp Peel Fruit Pulp Peel Fruit Pulp Peel 

0.02 0.21 0.02 0.01 

<0.01 

0.03 0.02 

<0.01 

0.03 0.01 

<0.01 

0.01 

0.073 

0.13 0.12 

0.075 0.045 

0.24 

0.076 0.053 

0.21 

0.069 0.035 

0.11 

0.015 0.023 0.026 0.019 

<0.012 

0.086 0.023 

<0.012 

0.080 0.017 

<0.012 

0.044 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.010 0.012 0.015 0.014 0.008 0.048 0.015 0.008 0.061 0.018 0.008 0.044 

0.13 

0.387 0.193 

0.13 

0.087 0.416 0.146 0.095 0.393 0.126 0.077 

0.22 

0* 

0 7 

14 14 14 21 21 21 28 28 28 

formulation: 100 OD 
- 250 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330

monoh

ydroxy 

BYI 

08330 

enolGlc 

Total as 

BYI 

08330 

PHI 

[days] Remarks 

RA-2033/04 R 2004 0143/4 P-Chamusca, Portugal 

Manderin / Tangera 

1. 15.03.1986 2. 30.03.2004 3. 01.11.-28.11.2004 

0.288 0.288 

3000 3000 

0.010 0.010 

23.09.2004 14.10.2004 

BBCH 81 Fruit 

Pulp Peel Fruit Pulp Peel Fruit Pulp Peel 

0.01 

<0.01 

0.02 0.01 

<0.01 

0.02 0.01 

<0.01 

0.02 

0.15 

0.072 

0.21 0.14 

0.077 

0.18 0.10 

0.062 

0.13 

<0.012 <0.012 

0.031 

<0.012 <0.012 

0.026 

<0.012 <0.012 

0.016 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.029 0.008 0.075 0.035 0.008 0.081 0.032 0.008 0.073 

0.213 0.114 0.348 0.209 0.119 0.319 0.166 0.104 0.251 

15 15 15 21 21 21 29 29 29 

formulation: 100 OD 

RA-2033/04 R 2004 0237/6 E-46400 Cullera, Spain 

Manderin / Satsuma 

1. 1977 2. 10.03.2004 3. 20.10-22.10.2004 

0.240 0.240 

2500 2500 

0.010 0.010 

22.09.2004 13.10.2004 

BBCH 79 Fruit 

Fruit Fruit Pulp Peel Fruit Pulp Peel Fruit Pulp Peel 

0.03 0.20 0.09 

<0.01 

0.29 0.06 

<0.01 

0.16 0.03 

<0.01 

0.07 

0.070 

0.12 0.15 

0.060 

0.43 0.13 

0.054 

0.34 0.12 

0.068 

0.20 

0.019 0.026 0.035 0.012 

0.14 

0.036 

<0.012 

0.12 

0.026 0.012 0.068 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.020 0.023 0.044 0.011 

0.12 

0.047 0.011 

0.12 

0.050 0.015 

0.10 

0.151 0.381 0.331 0.105 0.992 0.285 0.099 0.752 0.238 0.117 

0.45 

0* 

0 

14 14 14 21 21 21 29 29 29 

formulation: 100 OD 

RA-2033/04 R 2004 0238/4 E-41310 Brenes, Spain 

Mandarin / Clemenules 

1. 15.06.1994 2. 30.03.2004 3. 20.10-15.12.2004 

0.240 0.240 

2500 2500 

0.010 0.010 

27.09.2004 18.10.2004 

BBCH 81 Fruit 

Fruit Fruit Fruit Pulp Peel Fruit Pulp Peel Fruit Pulp Peel

0.03 0.19 0.01 0.01 

<0.01 

0.01 0.01 

<0.01 

0.01 0.01 

<0.01 

0.01

0.066 0.098 0.088 0.066 0.045 

0.14 

0.069 0.034 

0.11 

0.075 0.022 0.071

0.015 0.016 0.018 0.013 

<0.012 

0.057 0.012 

<0.012 

0.052 0.013 

<0.012 

0.038

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012

0.018 0.016 0.018 0.016 0.008 0.068 0.021 0.008 0.065 0.030 0.008 0.055

0.141 0.332 0.146 0.117 0.087 0.287 0.124 0.076 0.249 

0.14 

0.064 0.186

0* 

0 7 

15 15 15 21 21 21 28 28 28

formulation: 100 OD 
- 251 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330

monoh

ydroxy 

BYI 

08330 

enolGlc 

Total as 

BYI 

08330 

PHI 

[days] Remarks 

RA-2002/05 

R 2005 0041/6 

P-2950 

Palmela, 

Portugal 

Mandarin / 

Tangerina 

de Setúbal 

1. 15.02.1984 2. 15.03.2005 3. 01.12.2005 

– 10.01.2006 

0.288 0.288 

3000 3000 

0.010 0.010 

25.10.2005 15.11.2005 

BBCH 85 Fruit 

Fruit 

Pulp 

Peel 

Fruit Pulp Peel Fruit Pulp Peel 

0.18 0.01 

<0.01 

0.02 0.01 

<0.01 

0.02 0.01 

<0.01 

0.03 

0.084 0.059 0.032 

0.14 

0.045 0.029 

0.11 

0.046 0.032 0.094 

0.012 0.012 

<0.012 

0.026 0.012 

<0.012 

0.026 0.012 

<0.012 

0.030 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 

<0.008 

0.019 0.008 

<0.008 

0.020 0.008 

<0.008 

0.026 

0.296 0.101 0.074 0.217 0.087 0.071 0.188 0.088 0.074 0.192 

0 

14 14 14 21 21 21 28 28 28 

formulation: 150 OD 

RA-2002/05 R 2005 0042/4 E-46197 Alfarp, Spain 

Mandarin / Arrufatina 

1. 20.01.1994 2. 01.04.2005 3. 15.10.– 15.11.2005 

0.240 0.240 

2500 2500 

0.010 0.010 

14.09.2005 05.10.2005 

BBCH 81 Fruit 

Fruit Pulp Peel Fruit Pulp Peel Fruit Pulp Peel 

0.11 0.07 0.01 0.23 0.04 

<0.01 

0.14 0.06 

<0.01 

0.09 

0.078 

0.16 

0.098 

0.57 0.12 

0.083 

0.30 0.12 0.10 0.33 

0.012 0.013 0.012 0.067 0.012 

<0.012 

0.040 0.014 0.012 0.051 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.018 0.008 0.064 0.018 0.008 0.055 0.025 0.012 0.085 

0.22 

0.273 

0.14 

0.943 0.202 0.125 0.547 0.231 0.146 0.568 

0 

14 14 14 21 21 21 28 28 28 

formulation: 150 OD 

RA-2002/05 R 2005 0043/2 I-97019 Vittoria, Italy 

Mandarin / Tardivo di Ciaculli 

1. 1996 2. 10.04.2005 3. 20.01.– 25.02.2006 

0.192 0.192 

2000 2000 

0.010 0.010 

21.12.2005 11.01.2006 

BBCH 85 Fruit 

Fruit Pulp Peel Fruit Pulp Peel Fruit Pulp Peel 

0.15 0.10 

<0.01 

0.24 0.02 

<0.01 

0.04 0.02 

<0.01 

0.04 

0.022 0.033 

<0.012 

0.16 

0.031 

<0.012 

0.10 

0.034 

<0.012 

0.087 

0.013 0.032 

<0.012 

0.11 

0.015 

<0.012 

0.064 0.018 

<0.012 

0.046 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 

0.008 

<0.008 

0.012 0.008 

<0.008 

0.015 0.008 

<0.008 

0.016 

0.205 0.185 0.054 0.534 0.086 0.054 0.231 0.092 0.054 0.201 

0 

14 14 14 21 21 21 28 28 28 

formulation: BYI 08330 150 OD 
- 252 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330

monoh

ydroxy 

BYI 

08330 

enolGlc 

Total as 

BYI 

08330 

PHI 

[days] Remarks 

RA-2002/05 

R 2005 0044/0 

E-46400 

Cullera, Spain 

Mandarin / 

Satsuma 

1. 30.04.1977 2. 01.03.2005 3. 07.12.2005 

0.240 0.240 

2500 2500 

0.010 0.010 

05.10.2005 26.10.2005 

BBCH 81 Fruit 

Fruit Fruit 

Fruit 

Pulp 

Peel 

Fruit Pulp Peel Fruit Pulp Peel 

0.03 0.23 0.14 0.12 

<0.01 

0.25 0.03 

<0.01 

0.07 0.01 

<0.01 

0.03 

0.040 0.086 0.092 0.057 0.022 

0.22 

0.073 0.028 

0.18 

0.061 0.025 

0.13 

0.013 0.019 0.042 0.031 0.012 

0.12 

0.028 0.012 

0.10 

0.021 

<0.012 

0.077 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.009 

0.10 

0.018 0.012 0.008 0.054 0.020 0.008 0.058 0.018 0.008 0.053 

0.104 0.447 0.304 0.232 0.064 0.656 0.163 

0.07 0.42 

0.122 0.067 0.302 

0* 

0 7 

14 14 14 21 21 21 28 28 28 

formulation: 150 OD 

RA-2002/05 R 2005 0045/9 I-95045 Misterbianco, Italy 

Mandarin / Clementine Nules 

1. 1985 2. 15.04.2005 3. 01.11.– 31.12.2005 

0.2304 0.2304 

2400 2400 

0.010 0.010 

17.10.2005 07.11.2005 

BBCH 81 Fruit 

Fruit Fruit Fruit Pulp Peel Fruit Pulp Peel Fruit Pulp Peel 

0.02 0.19 0.06 0.04 

<0.01 

0.06 0.04 

<0.01 

0.10 0.03 

<0.01 

0.06 

0.041 0.072 0.075 0.066 0.016 

0.20 

0.069 0.022 

0.23 

0.068 0.023 

0.16 

0.012 0.021 0.036 0.033 

<0.012 

0.11 

0.034 

<0.012 

0.14 

0.036 

<0.012 

0.096 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.011 0.008 0.014 

<0.008 

0.043 0.018 0.008 0.064 0.022 0.008 0.065 

0.093 0.306 0.191 0.165 0.058 0.425 0.173 0.064 0.546 0.168 0.065 0.393 

0* 

0 7 

14 14 14 21 21 21 28 28 28 

formulation: 150 OD 

* before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) CH Canopy height 
- 253 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I b: Summary of trial information - lettuce 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Greenhouse trials RA-2054/04 R 2004 0393/3 D-40764 Langenfeld, Germany 

Lettuce / Alexandria 

(Butterhead variety)

1. 22.04.2004 3. 15.06.2004 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

18.05.2004 25.04.2004 01.06.2004 

BBCH 47 head 

head head head head head 

0.04 0.35 0.38 0.28 0.02 0.01 

0.096 

0.35 0.27 0.25 

0.091 0.053 

0.031 0.076 0.043 0.061 0.039 0.013 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.030 0.037 0.037 0.052 0.060 0.081 

0.209 0.825 0.742 0.655 0.222 0.169 

0* 0 1 3 7 13 

formulation: 100 OD 

RA-2054/04 R 2004 0394/1 F-31790 St. Jory, Southern France 

Lettuce / Alexandria 

(Butterhead variety)

1. 24.03.2004 3. 15.05.2004 

0.072 0.072 0.072 

1000 1000 1000 

0.007 0.007 0.007 

29.04.2004 05.05.2004 12.05.2004 

BBCH 48 head 

head head head head head 

0.07 0.49 0.63 0.06 0.02 0.01 

0.12 0.69 0.32 0.18 

0.080 0.031 

0.041 

0.16 

0.090 0.047 0.025 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.022 0.042 0.027 0.038 0.059 0.067 

0.265 1.394 1.079 0.337 0.196 0.132 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2054/04 R 2004 0396/8 D-42799 Leichlingen, Germany 

Lettuce / Roderik 

(Butterhead variety)

1. 02.02.2004 3. 15.04.2004 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

30.03.2004 06.04.2004 13.04.2004 

BBCH 47 head 

head head head 

2.2 1.7 1.5 1.9 

0.66 0.50 0.54 0.59 

0.079 0.059 0.070 0.079 

<0.012 <0.012 <0.012 <0.012 

0.014 0.012 0.017 0.032 

2.965 2.283 2.139 2.613 

0 1 3 6 

formulation: 100 OD 

RA-2054/04 R 2004 0397/6 I-00050 Palidoro Fiumicino, Italy 

Lettuce / Kereon 

(Butterhead variety)

1. 11.03.2004 3. 26.04.2004 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

09.04.2004 16.04.2004 23.04.2004 

BBCH 48 head 

head head head 

1.9 1.7 1.3 1.2 

0.35 0.37 0.28 0.21 

0.070 0.072 0.046 0.032 

<0.012 <0.012 <0.012 <0.012 

0.037 0.042 0.043 0.048 

2.369 2.196 1.681 1.502 

0 1 3 7 

formulation: 100 OD 

RA-2054/04 R 2004 0398/4 I-70043 Monopoli, Italy 

Lettuce / Lollo rosso 

(Loose-Leaf variety)

1. 11.10.2004 3. 05.01-18.01.2005 

0.072 0.072 0.072 

800 800 800 

0.009 0.009 0.009 

22.12.2004 29.12.2004 05.01.2005 

BBCH 43 head 

head head head head head 

1.7 5.9 5.1 3.7 2.6 

0.60 

0.49 0.73 0.68 0.76 0.53 0.24 

0.13 0.14 0.14 0.17 0.15 

0.079 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.051 0.056 0.052 

0.13 0.15 

0.093 

2.383 6.838 5.984 4.772 3.442 1.024 

0* 0 1 3 6 14 

formulation: 100 OD 
- 254 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2054/04 R 2004 0399/2 E-08410 Bigues, Spain 

Lettuce / Baravia 

(Loose-Leaf variety)

1. 20.01.2004 3. 15.03.2004 

0.0720 0.0774 0.0720 

800 860 1000 

0.009 0.009 0.007 

23.02.2004 01.03.2004 08.03.2004 

BBCH 46 – 49 

head head head head head head 

0.54 

1.4 1.2 

0.73 0.52 0.39 

0.52 0.75 0.71 0.60 0.51 0.22 

0.18 0.24 0.22 0.22 0.17 

0.081 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.057 0.058 0.071 0.067 0.084 0.074 

1.309 2.46 2.213 1.629 1.296 0.777 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2054/04 R 2004 0401/8 I-70043 Monopoli, Italy 

Lettuce / Versai RZ 

(Loose-Leaf variety)

1. 28.12.2003 3. 15.03.2004 

0.072 0.072 0.072 

800 800 800 

0.009 0.009 0.009 

27.02.2004 05.03.2004 12.03.2004 

BBCH 49 head 

head head head 

2.2 1.1 1.4 1.0 

0.55 0.35 0.31 0.27 

0.18 0.11 

0.093 0.096 

<0.012 <0.012 <0.012 <0.012 

0.056 0.037 0.049 0.067 

2.998 1.609 1.864 1.445 

0 1 3 7 

formulation: 100 OD 

RA-2054/04 R 2004 0402/6 E-41310 Brenes, Spain 

Lettuce / Solsun (Nun 8801 LT) 

(Loose-Leaf variety)

1. 19.10.2004 3. 01.12.2004 – 28.02.2005 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

27.12.2004 03.01.2005 10.01.2005 

BBCH 47 head 

head head head 

2.8 1.9 2.6 1.7 

0.25 0.20 0.31 0.20 

0.041 0.035 0.052 0.038 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 

0.008 

3.111 2.155 2.982 1.958 

0 1 3 7 

formulation: 100 OD 

RA-2170/05 R 2005 1023/3 GR-19007 Kato Souli, Greece 

Lettuce / Manita 

1. 11.09.-10.10.2005 3. 21.-22.12.2005 

0.072 0.072 

500 500 

0.014 0.014 

24.11.2005 08.12.2005 

BBCH 45 head 

head head head head head 

0.10 

1.5 1.6 1.4 

0.70 0.58 

0.12 0.31 0.37 0.40 0.26 0.28 

0.026 0.039 0.057 0.063 0.053 0.053 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.027 0.025 0.033 0.034 0.032 0.046 

0.285 1.886 2.072 1.909 1.057 0.971 

0* 0 1 3 7 14 

formulation: 150 OD 

RA-2170/05 R 2005 1024/1 F-86380 Quyilly, France 

Lettuce / Bastille 

1. 15.09.2005 3. 29.10.-10.11.2005 

0.072 0.072 

800 800 

0.009 0.009 

10.10.2005 24.10.2005 

BBCH 48 head 

head head head head head 

0.11 

2.0 2.1 1.6 

0.19 0.09 

0.038 

0.57 0.16 0.18 

0.078 0.023 

0.063 

0.11 0.15 0.17 

0.084 0.052 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.015 0.022 0.017 0.018 0.023 0.013 

0.238 2.714 2.439 

1.98 

0.387 

0.19 

0* 0 1 3 7 14 

formulation: 150 OD 

RA-2170/05 R 2005 1026/8 NL-1852 RH Heiloo, Netherlands 

Lettuce / Varinka 

1. 14.09.-05.10.2005 3. 12.-15.12.2005 

0.072 0.072 

1000 1000 

0.007 0.007 

22.11.2005 06.12.2005 

BBCH 48 head 

head head head head head 

0.45 

1.6 1.5 1.4 1.3 

0.87 

0.18 0.34 0.30 0.29 0.35 0.26 

0.063 0.067 0.085 0.082 0.086 0.066 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.713 2.027 1.905 1.792 1.756 1.216 

0* 0 1 3 7 14 

formulation: 150 OD 
- 255 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2170/05 R 2005 1027/6 P-2560 Torres Vedras, Portugal 

Lettuce / Tradition 

1. 18.08.2005 3. 26.-27.09.2005 

0.072 0.072 

500 500 

0.014 0.014 

26.08.2005 09.09.2005 

BBCH 41 head 

head head head head head 

<0.01 

1.4 1.6 1.4 

0.17 0.02 

<0.012 

1.0 

0.38 0.33 0.12 

0.043 

<0.012 

0.067 

0.11 

0.099 0.034 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 

0.015 0.020 0.045 0.038 0.024 

0.054 2.494 2.122 1.886 0.374 0.111 

0* 0 1 3 7 14 

formulation: 150 OD 

RA-2170/05 R 2005 1028/4 F-31790 St. Jory, France 

Lettuce / Cabanon 

1. 20.09.2005 3. 05.-15.01.2006 

0.072 0.072 

800 800 

0.009 0.009 

19.12.2005 03.01.2006 

BBCH 45 head 

head 

1.8 1.5 

0.22 0.23 

0.047 0.081 

<0.012 <0.012 

0.008 0.012 

2.087 1.835 

0 7 

formulation: 150 OD 

RA-2170/05 R 2005 1029/2 F-84140 Montfavet, France 

Lettuce / Arcadia 

1. 20.09.-05.10.2005 3. 28.-29.11.2005 

0.072 0.072 

1000 1000 

0.007 0.007 

07.11.2005 21.11.2005 

BBCH 48 head 

head 

1.5 

0.85 

0.66 0.41 

0.11 0.12 

<0.012 <0.012 

0.015 0.014 

2.297 1.406 

0 7 

formulation: 150 OD 

RA-2170/05 R 2005 1030/6 D-40764 Langenfeld, Germany 

Lettuce / Alexandria 

1. 26.07.2005 3. 30.08.-10.09.2005 

0.072 0.072 

600 600 

0.012 0.012 

10.08.2005 24.08.2005 

BBCH 43 head 

head 

1.3 

0.05 

0.30 

0.056 

0.014 0.031 

<0.012 <0.012 

0.008 0.014 

1.634 0.163 

0 7 

formulation: 150 OD 

RA-2170/05 R 2005 1031/4 E-08410 Bigues i Riells, Spain 

Lettuce / Batavia 

1. 26.09.2005 3. 28.12.2005 – 05.01.2006 

0.0764 0.0720 

636 900 

0.008 0.012 

07.12.2005 20.12.2005 

BBCH 48 head 

head 

1.8 1.6 

0.57 0.58 

0.12 0.12 

<0.012 <0.012 

0.008 0.015 

2.51 

2.327 

0 7 

formulation: 150 OD 

RA-2113/04 R 2004 0685/1 D-40764 Langenfeld, Germany 

Lettuce / Alexandria 

1. 22.04.2004 3. 15.06.2004 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

18.05.2004 25.05.2004 01.06.2004 

BBCH 47 head 

head head head head head 

0.02 0.42 

0.5 

0.31 0.03 0.01 

0.088 

0.38 0.29 0.21 

0.1 

0.054 

0.023 0.093 0.048 0.037 0.028 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.036 0.042 0.051 0.056 

0.07 

0.084 

0.179 0.947 0.901 0.625 

0.24 

0.172 

0* 0 1 3 7 13 

formulation: 240 SC; addition of 0.2% RME 500 
- 256 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2113/04 R 2004 0687/8 I-70043 Monopoli, Italy 

Lettuce / Lollo rosso 

1. 11.10.2004 3. 05.01. – 18.01.2005 

0.072 0.072 0.072 

800 800 800 

0.009 0.009 0.009 

22.12.2004 29.12.2004 05.01.2005 

BBCH 43 head 

head head head head head 

1.2 4.2 3.2 1.7 

0.99 0.21 

0.36 0.66 0.49 0.62 0.41 0.23 

0.12 0.15 0.12 0.14 0.11 

0.069 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.042 0.043 0.042 

0.11 0.12 0.11 

1.734 5.065 3.864 2.582 1.642 0.631 

0* 0 1 3 7 14 

formulation: 240 SC; addition of 0.2% RME 500 

RA-2113/04 R 2004 0688/6 E-41340 Brenes, Spain 

Lettuce / Solsun (Nun 8801 LT) 

1. 19.10.2004 3. 01.12.2005 – 28.02.2005 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

27.12.2004 03.01.2005 10.01.2005 

BBCH 47 head 

head head head head 

1.1 1.8 2.2 1.7 1.5 

0.15 0.21 0.29 0.18 0.21 

0.036 0.032 

0.05 

0.044 0.044 

<0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 

1.306 2.062 

2.56 

1.944 1.774 

0* 0 1 3 7 

formulation: 240 SC; addition of 0.2% RME 500 

RA-2113/04 R 2004 0689/4 D-42799 Leichlingen, Germany 

Lettuce / Roderick 

1. 02.02.2004 3. 15.04.2004 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

30.03.2004 06.04.2004 13.04.2004 

BBCH 47 head 

head head head head 

1.2 2.1 1.8 1.6 1.5 

0.19 0.28 0.25 0.27 0.21 

0.064 0.081 0.089 

0.08 

0.066 

<0.012 <0.012 <0.012 <0.012 <0.012 

0.01 

0.012 

0.01 0.13 

0.019 

1.476 2.485 2.161 2.092 1.807 

0* 0 1 3 6 

formulation: 240 SC; addition of 0.2% RME 500 

Field conditions – Northern Europe RA-2052/04 R 2004 0385/2 NL-1681 ND ZwaagdijkOost, Netherlands 

Lettuce / Ponchito (Butterhead variety) 

1. 10.06.2004 3. 28.07 – 04.08.2004 

0.072 0.072 0.072 

800 800 800 

0.009 0.009 0.009 

13.07.2004 21.07.2004 28.07.2004 

BBCH 44 head 

head head head head head 

0.03 0.53 0.46 0.37 0.17 0.03 

0.085 

0.15 0.18 

0.2 0.1 

0.026 

0.05 0.05 

0.057 0.064 0.082 0.019 

<0.012 <0.012 <0.012 <0.012 <0.012

<0.012 

0.033 0.031 

0.04 

0.057 0.077 0.063 

0.21 

0.773 0.749 0.703 0.441 

0.15 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2052/04 R 2004 0386/0 D-40764 Langenfeld, Germany 

Lettuce / Ponchito 

(Butterhead variety)

1. 22.04.2004 3. 15.06.2004 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

25.05.2004 01.06.2004 08.06.2004 

BBCH 48 head 

head head head 

0.37 0.39 0.05 0.01 

0.3 

0.24 0.12 

0.055 

0.09 

0.074 0.049 0.021 

<0.012 <0.012 <0.012 <0.012 

0.014 0.015 0.024 0.019 

0.786 0.731 0.255 0.117 

0 1 3 6 

formulation: 100 OD 

RA-2052/04 R 2004 0387/9 D-53332 BornheimSechten, Germany 

Lettuce / Lollo Roso (Loose-Leaf 

variety)

1. 20.04.2004 3. 14.06. – 15.06.2004 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

18.05.2004 25.05.2004 01.06.2004 

BBCH 48 head 

head head head head head 

0.24 

1.2 1.2 

0.24 0.09 0.01 

0.14 0.64 0.46 

0.3 

0.13 

0.027 

0.15 0.19 0.18 0.14 

0.065 0.018 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.025 0.028 0.034 0.038 0.044 0.033 

0.567 

2.07 

1.886 

0.73 

0.341 

0.1 

0* 0 1 3 7 14 

formulation: 100 OD 
- 257 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2052/04 R 2004 0388/7 D-40764 Langenfeld, Germany 

Lettuce / Bastille 

(Loose-Leaf variety)

1. 22.04.2004 3. 15.06.2004 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

25.05.2004 01.06.2004 08.06.2004 

BBCH 48 head 

head head head 

0.58 0.13 0.01 0.01 

0.45 0.26 0.11 

0.068 

0.062 0.057 0.059 0.028 

<0.012 <0.012 <0.012 <0.012 

0.029 0.028 0.039 0.033 

1.133 0.487 

0.23 

0.151 

0 1 3 6 

formulation: 100 OD 

Field conditions – Southern Europe RA-2053/04 R 2004 0389/5 F-69480 Lucenay, France 

Lettuce / 4509 

1. 03.05.2004 3. 06.06. – 22.06.2004 

0.072 0.072 0.072 

550 550 550 

0.013 0.013 0.013 

25.05.2004 02.06.2004 08.06.2004 

BBCH 42 head 

head head head head head 

0.01 0.01 0.04 0.02 0.01 

<0.01 

0.046 0.054 

0.13 

0.076 0.043 0.013 

0.022 0.024 0.034 0.028 0.017 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.011 0.012 

0.02 

0.024 0.024 0.022 

0.101 0.112 0.236 

0.16 

0.106 0.069 

0* 0 1 3 6 14 

formulation: 100 OD 

RA-2053/04 R 2004 0390/9 E-08410 Vilanova del Vallés, Spain 

Lettuce / Iceberg 

1. 10.06.2004 3. 15.07. – 22.07.2004 

0.072 0.077 0.072 

600 856 1000 

0.012 0.009 0.007 

01.07.2004 07.07.2004 15.07.2004 

BBCH 47 head 

head head head 

0.74 

0.3 0.2 

0.04 

0.28 0.31 0.13 

0.041 

0.067 0.086 0.073 

0.02 

<0.012 <0.012 <0.012 <0.012 

0.045 0.046 0.053 0.042 

1.144 0.754 0.468 0.155 

0 1 3 7 

formulation: 100 OD 

RA-2053/04 R 2004 0391/7 P-2665-018 Azueira, Portugal 

Lettuce / Vision 

1. n.r. 3. n.r. 

0.072 0.072 0.072 

750 750 750 

0.010 0.010 0.010 

12.04.2004 19.04.2004 26.04.2004 

BBCH 32 head 

head head head head head 

0.03 

1.3 0.4 

0.33 0.05 0.02 

0.071 

0.52 0.32 0.19 

0.078 0.029 

0.025 0.056 0.083 0.085 0.028 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.018 

0.02 

0.021 0.021 

0.02 

0.014 

0.156 1.908 0.836 0.638 0.188 0.087 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2053/04 R 2004 0392/5 I-40128 Bologna, Italy 

Lettuce / Gentilina 

1. 18.08.2004 3. 01.10. – 15.10.2004 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

21.09.2004 28.09.2004 05.10.2004 

BBCH 49 head 

head head head 

0.85 0.48 0.26 0.04 

0.16 0.21 

0.2 

0.12 

0.039 0.056 0.087 0.035 

<0.012 <0.012 <0.012 <0.012 

0.037 0.031 

0.05 

0.058 

1.098 0.789 0.609 0.265 

0 1 3 7 

formulation: 100 OD 

* before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) n.r. not reported 
- 258 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I c: Summary of trial information – pome fruit 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Northern Europe RA-2135/04 R 2004 0795/5 D-51399 Burscheid, Germany 

Apple Jonagold 

1. 01.03.1983 2. 03.05.2004 3. 10.09.2004  - 30.10.2004 

0.1440 0.1440 

1000 1000 

0.014 0.014 

10.08.2004 24.08.2004 

BBCH 77 fruit 

fruit fruit fruit 

0.10 0.02 0.01 0.02 

<0.012 

0.016 0.012 0.012 

0.012 0.014 0.012 0.017 

<0.012 <0.012 <0.012 

0.012 

< 0.008 < 0.008 < 0.008 

0.008 

0.144 0.070 0.054 0.069 

0 

13 21 27 

formulation: 100 OD 

RA-2135/04 R 2004 0796/3 D-51399 Burscheid, Germany 

Pear Vereinsdechantbirne 

1. 01.03.1986 2. 20.04.2004 3. 01.09.2004 - 30.10.2004 

0.1440 0.1440 

1000 1000 

0.014 0.014 

10.08.2004 24.08.2004 

BBCH 77 fruit 

fruit fruit fruit 

0.15 0.02 0.02 0.01 

0.012 

<0.012 <0.012 <0.012 

0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 

0.194 0.064 0.064 

<0.054 

0 

13 21 27 

formulation: 100 OD 

RA-2135/04 R 2004 0797/1GB-SG8 8SS Royston, United Kingdom 

Apple Jonathan 

1. 1994 2. 12.04.2004 3. 01.10.2004 - 01.11.2004 

0.1370 0.1370 

950 950 

0.014 0.014 

08.09.2004 24.09.2004 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

0.07 0.21 0.12 0.07 0.04 0.02 

0.014 0.017 0.025 0.026 0.034 0.033 

0.012 0.012 0.018 0.013 0.021 0.025 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.116 0.259 0.183 0.129 0.115 0.098 

0 0 7 

13 21 28 

formulation: 100 OD 

RA-2135/04 R 2004 0799/8 F-78920 ECQUEVILLY, N-France 

Pear 

Conference

1. 25.09.1960 2. 10.04.2004 3. 07.09.2004 - 15.09.2004 

0.1440 0.1440 

600 600 

0.024 0.024 

06.08.2004 21.08.2004 

BBCH 78 fruit 

fruit fruit fruit fruit fruit 

0.03 0.14 0.06 0.06 0.05 0.03 

<0.012 

0.012 0.012 0.012 0.012 

<0.012 

<0.012 <0.012 

0.012 0.012 0.012 0.012 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.074 0.184 0.104 0.104 0.094 0.074 

0 0 6 

13 21 27 

formulation: 100 OD 

RA-2012/05 R 2005 0083/1 GB-CO6 5LEEssex, UK 

apple / Cox 

1. 1995 2. 25.04.2005 3. 19.09 – 17.10.2005 

0.144 0.144 

1000 1000 

0.014 0.014 

31.08.2005 14.09.2005 

BBCH 85 fruit 

leaf leaf leaf fruit leaf fruit fruit 

0.11 

9.5 6.2 5.5 

0.05 

3.2 

0.03 0.01 

0.023 

0.77 0.35 

0.6 

0.031 

0.17 

0.034 0.021 

0.012 

0.59 

1.1 1.1 

0.014 

1.3 

0.015 0.019 

<0.012 

0.012 0.012 0.012 

<0.012 

0.012 

<0.012 <0.012 

<0.008 

0.008 0.008 

0.01 

<0.008 

0.011 

<0.008 <0.008 

0.165 10.88 

7.67 

7.222 0.115 4.693 0.099 

0.07 

0 0 3 6 

14 14 21 29 

formulation: 150 OD 
- 259 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2012/05 R 2005 0085/8 GB-CB4 5HGCambgidge, UK 

pear / 

Conference

1. 1988 2. 10.04.2005 3. 05.09 – 23.09.2005 

0.144 0.144 

1000 1000 

0.014 0.014 

16.08.2005 30.08.2005 

BBCH 81 fruit 

leaf leaf leaf fruit leaf fruit fruit 

0.38 

24 19 

5.4 

0.08 

3.5 

0.05 0.04 

0.024 

1.5 

0.56 0.24 

0.012 

0.13 

0.012 0.012 

0.012 

0.37 0.97 0.45 

0.022 

0.37 

0.016 0.012 

0.012 0.037 0.072 0.084 0.012 0.083 0.012 0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.436 

25.915 

20.61 6.182 0.134 4.091 0.098 0.084 

0 0 3 7 

14 14 21 28 

formulation: 150 OD 

RA-2012/05 R 2005 0086/6 D-88069 Bernau, Germany 

apple / Jonagold 

1. 01.03.1993 2. 30.04.2005 3. 21.09 – 24.10.2005 

0.1872 0.1872 

1300 1300 

0.014 0.014 

17.08.2005 31.08.2005 

BBCH 85 fruit 

fruit leaf leaf fruit leaf fruit leaf fruit fruit 

0.02 0.12 

13 

9.6 

0.10 

7.2 

0.03 

2.2 

0.03 0.02 

0.016 0.017 

0.79 0.75 

0.022 

0.28 

0.019 0.093 0.021 0.012 

0.012 0.012 

0.76 

1.2 

0.015 

1.1 

0.018 

0.64 

0.023 0.017 

<0.012 <0.012 

0.019 0.024 0.012 0.039 0.012 0.043 0.012 0.012 

<0.008 <0.008 

0.008 0.010 

<0.008 

0.017 

<0.008 

0.018 0.008 

<0.008 

0.068 0.169 

14.577 11.584 

0.157 8.636 0.087 2.994 0.094 0.069 

0* 

0 0 2 7 7 

14 14 21 28 

formulation: 150 OD 

RA-2012/05 R 2005 0087/4 D-65366 Geisenheim, Germany 

pear / 

Conference

1. 15.11.1984 2. 13.04.2005 3. 05.09. – 19.09.2005 

0.144 0.144 

1000 1000 

0.014 0.014 

04.08.2005 18.08.2005 

BBCH 81 fruit 

fruit leaf leaf fruit leaf fruit leaf fruit fruit 

0.04 0.25 

24 22 

0.22 

19 

0.14 

13 

0.1 

0.06 

0.012 0.023 

1.5 

0.43 

0.013 

0.56 

0.012 

0.44 

0.012 0.012 

0.012 0.012 

0.5 

0.78 

0.013 

0.53 

0.017 

0.77 

0.016 0.014 

0.013 0.014 

0.23 0.21 0.02 0.22 

0.021 

0.25 0.02 

0.021 

<0.008 <0.008 

0.008 0.009 0.008 0.008 0.008 0.008 0.008 

<0.008 

0.085 0.307 

26.238 23.429 

0.274 

20.318 

0.198 

14.468 

0.156 0.115 

0* 

0 0 3 7 7 

14 14 21 28 

formulation: 150 OD 

RA-2012/05 R 2005 1018/7 D-4808 WurzenRoitzsch, Germany 

apple / Gloster 

1. 01.10.1989 2. 20.04.2005 3. 20.08. – 24.10.2005 

0.216 0.216 

1500 1500 

0.014 0.014 

26.07.2005 08.08.2005 

BBCH 77 fruit 

fruit fruit fruit 

0.14 0.08 0.07 0.06 

0.022 0.049 0.052 0.037 

0.012 0.012 0.013 0.012 

<0.012 

0.012 0.012 0.012 

<0.008 <0.008 

0.008 0.008 

0.194 0.161 0.155 0.129 

0 

15 22 29 

formulation: 150 OD 
- 260 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2138/04 R 2004 0809/9 D-51399 Burscheid, Germany 

apple / Mutzu 

1. 01.03.1983 2. 22.04.2004 3. 15.10. – 31.10.2004 

0.144 0.144 

1000 1000 

0.014 0.014 

06.09.2004 20.09.2004 

BBCH 81 fruit 

fruit fruit fruit 

0.13 0.01 0.02 0.01 

<0.012 

0.012 0.012 0.012 

<0.012 <0.012 

0.012 0.012 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 

0.008 

<0.008 

0.174 0.054 0.064 0.054 

0 

14 21 28 

formulation: 240 SC; addition of 0.2% RME 500 

RA-2138/04 R 2004 0810/2 D-51399 Burscheid, Germany 

pear / Tongern 

1. 01.03.1986 2. 20.04.2004 3. 15.09. – 30.09.2004 

0.144 0.144 

1000 1000 

0.014 0.014 

10.08.2004 24.08.2004 

BBCH 77 fruit 

fruit fruit fruit 

0.18 0.15 0.14 0.14 

0.039 0.034 0.033 0.031 

0.035 0.033 0.029 0.027 

0.053 0.046 0.044 0.043 

0.008 0.008 0.008 0.008 

0.315 0.271 0.254 0.249 

0 

13 21 27 

formulation: 240 SC 

RA-2138/04 R 2004 0811/0 GB-SG8 8SS Royston, UK 

apple / Jonathan 

1. 1994 2. 12.04.2004 3. 01.10. – 01.11.2004 

0.1368 0.1368 

950 950 

0.014 0.014 

08.09.2004 24.09.2004 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

0.02 0.23 0.06 

<0.01 

0.02 0.01 

<0.012 

0.012 0.012 

<0.012 

0.012 0.012 

<0.012 

0.012 0.012 

<0.012 

0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.064 0.274 0.104 0.054 0.064 0.054 

0* 

0 7 

13 21 28 

formulation: 240 SC; 2nd

application: addition of 0.2% RME 500; water rate 300 L/ha per m CH 

RA-2138/04 R 2004 0812/9 F-78920 Ecquevilly, NFrance 

pear / 

Conference

1. 25.09.1960 2. 10.04.2004 3. 07.09. – 15.09.2004 

0.144 0.144 

600 600 

0.024 0.024 

06.08.2004 21.08.2004 

BBCH 78 fruit 

fruit fruit fruit fruit fruit 

0.03 0.19 0.11 0.06 0.07 0.05 

<0.012 

0.012 0.012 0.012 0.012 

<0.012 

<0.012 

0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 

0.012 0.012 0.012 0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 

0.008 

0.074 0.234 0.154 0.104 0.114 0.094 

0* 

0 6 

13 21 27 

formulation: 240 SC; addition of 0.2% RME 500 

Southern Europe RA-2137/04 R 2004 0805/9 I-44043 Mirobello, Italy 

apple / 

Nero Red Rome

1. 10.01.1987 2. 10.04.2004 3. 20.09. – 15.10.2004 

0.216 0.216 

1500 1500 

0.014 0.014 

24.08.2004 07.09.2004 

BBCH 81 fruit 

fruit fruit fruit 

0.30 0.06 0.04 0.05 

0.019 0.015 0.014 0.013 

0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 

0.012 

<0.008 <0.008 <0.008 <0.008 

0.351 0.107 0.086 0.095 

0 

14 21 28 

Form.: 100 OD 

RA-2137/04 R 2004 0806/4 I-44040 Merelli, Italy 

pear / 

Abate fetel

1. 10.01.1980 2. 20.04.2004 3. 25.08. – 15.09.2004 

0.216 0.216 

1500 1500 

0.014 0.014 

06.08.2004 21.08.2004 

BBCH 79 fruit 

fruit fruit fruit 

0.27 0.10 0.07 0.10 

0.033 0.012 0.012 0.012 

0.02 

0.019 0.013 0.019 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 

0.343 0.151 0.115 0.151 

0 

14 21 28 

formulation: 100 OD 

RA-2137/04 R 2004 0807/2 E-17474 

apple / 

Golden

1. 01.02.1990 2. 01.04.2004 3. 15.09. – 

0.216 0.216 

1500 1500 

0.014 0.014 

05.08.2004 20.08.2004 

BBCH 81 fruit 

fruit fruit 

0.09 0.23 0.20 

0.013 0.016 0.023 

0.019 

0.02 

0.034 

0.017 0.016 0.027 

<0.008 

0.008 0.008 

0.147 

0.29 

0.292 

0* 

0 

10 

formulation: 100 OD 
- 261 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Vilamacolum, Spain 

20.09.2004 fruit 

fruit fruit 

0.12 0.10 0.05 

0.022 0.015 0.012 

0.034 0.041 0.032 

0.025 0.028 0.021 

0.008 0.008 0.008 

0.209 0.192 0.123 

14 20 27 

RA-2137/04 R 2004 0808/0 F-69380 Les Chères, SFrance 

pear – Passe crassane 

1. 10.01.1987 2. 10.04.2004 3. 20.09. – 15.10.2004 

0.1872 0.1872 

650 650 

0.029 0.029 

06.08.2004 21.08.2004 

BBCH 76 fruit 

fruit fruit fruit fruit fruit 

0.12 0.38 0.18 0.15 0.14 0.14 

0.030 0.063 0.038 0.033 0.033 0.032 

0.026 0.039 0.034 0.031 0.027 0.027 

0.032 

0.13 

0.053 0.045 0.041 0.041 

0.008 0.008 0.008 0.008 0.008 0.008 

0.216 

0.62 

0.313 0.267 0.249 0.248 

0* 

0 7 

14 21 28 

formulation: 100 OD; water rate 250 L/ha per m CH 

RA-2015/05 R 2005 0088/2 F-79310 SaintPardoux, SFrance 

apple / 

Braeburn

1. 10.01.1985 2. 13.04.2005 3. 01.10. – 31.10.2005 

0.1872 0.1872 

1300 1300 

0.014 0.014 

09.09.2005 23.09.2005 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

0.03 0.11 0.08 0.04 0.04 0.03 

0.012 0.012 0.012 0.013 0.022 

0.02 

<0.012 <0.012 

0.012 0.012 0.014 0.023 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.074 0.154 0.124 0.085 0.096 0.093 

0* 

0 7 

14 21 28 

formulation: 150 OD 

RA-2015/05 R 2005 0089/0 I-40128 Bologna, Italy 

apple / 

Jonathan

1. 01.02.1988 2. 15.04.2005 3. 05.08. – 15.08.2005 

0.1584 0.1584 

1100 1100 

0.014 0.014 

05.07.2005 19.07.2005 

BBCH 78 fruit 

fruit fruit fruit 

0.11 0.06 0.08 0.02 

0.012 0.012 0.012 0.012 

0.012 0.012 0.015 0.012 

0.012 0.012 0.014 0.012 

<0.008 

0.008 0.008 0.008 

0.154 0.104 0.129 0.064 

0 

14 21 28 

formulation: 150 OD 

RA-2015/05 R 2005 0090/4 F-31330 Grenade, SFrance 

pear – Beurre Hardy 

1. 01.01.1975 2. 25.03.2005 3. 18.08. – 23.08.2005 

0.1800 0.1800 

1250 1250 

0.014 0.014 

13.07.2005 27.07.2005 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

0.04 0.14 0.05 0.05 0.02 0.02 

0.012 0.022 0.012 0.012 0.012 

<0.012 

0.02 

0.016 0.029 0.029 0.022 0.018 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.092 0.198 0.111 0.111 0.074 0.070 

0* 

0 7 

14 21 28 

formulation: 150 OD 

RA-2015/05 R 2005 0091/2 I-37050 Albaro Di Ronco All’Adige, Italy 

pear – William 

1. 1995 2. 10.04.2005 3. 15.08. – 25.08.2005 

0.216 0.216 

1500 1500 

0.014 0.014 

12.07.2005 26.07.2005 

BBCH 78 fruit 

fruit fruit fruit 

0.11 0.03 0.02 0.01 

0.012 

<0.012 <0.012 <0.012 

0.012 0.014 0.014 

<0.012 

<0.012 <0.012 

0.012 0.012 

<0.008 <0.008 <0.008 <0.008 

0.154 0.076 0.066 0.054 

0 

14 21 28 

formulation: 150 OD 

RA-2136/04 R 2004 0800/5 I-44043 Mirabello, Italy 

apple / 

Nero Red Rome

1. 10.01.1987 2. 10.04.2004 3. 20.09. – 15.10.2004 

0.216 0.216 

1500 1500 

0.014 0.014 

24.08.2004 07.09.2004 

BBCH 81 fruit 

fruit fruit fruit 

0.35 0.04 0.01 0.01 

0.019 0.012 0.012 0.012 

0.015 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 

0.404 0.084 

<0.054 <0.054 

0 

14 21 28 

formulation: 240 SC 0.2 % additive RME 500 EW was added 
- 262 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2136/04 R 2004 0800/5 I-44040 Dodici Morelli, Italy 

pear / 

Abate fetel

1. 10.01.1980 2. 20.04.2004 3. 25.08. – 15.09.2004 

0.216 0.216 

1500 1500 

0.014 0.014 

22.07.2004 05.08.2004 

BBCH 79 fruit 

fruit fruit fruit 

0.22 

0.1 

0.08 0.09 

0.032 0.012 0.012 0.012 

0.012 0.024 0.018 0.018 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 

0.284 0.156 

0.13 0.14 

0 

14 21 28 

formulation: 240 SC; addition of 0.2 % RME 500 EW; water rate 250 L/ha per m CH 

RA-2136/04 R 2004 0802/1 E-17474 Vilamacolum, Spain 

apple / 

Golden

1. 01.02.1990 2. 01.04.2004 3. 15.09. – 20.09.2004 

0.216 0.216 

1500 1500 

0.014 0.014 

05.08.2004 20.08.2004 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

0.14 0.33 0.25 0.11 0.09 0.05 

0.012 0.012 0.012 0.013 0.012 0.012 

0.012 0.012 0.017 0.019 0.022 0.014 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.184 0.374 0.299 0.162 0.144 0.096 

0* 

0 

10 14 20 27 

formulation: 240 SC addition of 0.2 % RME 500 EW 

RA-2136/04 R 2004 0804/8 F-69380 Les Chères, SFrance 

pear – Passe crassane 

1. 01.01.1962 2. 12.04.2004 3. 03.09.2004 

0.1872 0.1872 

650 650 

0.029 0.029 

29.07.2004 13.08.2004 

BBCH 76 fruit 

fruit fruit fruit fruit fruit 

<0.01 

0.14 0.02 

<0.01 

0.01 

<0.01 

<0.012 

0.012 

<0.012 <0.012 <0.012 <0.012 

<0.012 

0.012 0.012 

<0.012 

0.012 

<0.012 

<0.012 

0.012 0.012 

<0.012 

0.012 

<0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.054 0.184 0.064 0.054 

<0.054 <0.054 

0* 

0 7 

14 21 28 

formulation: 240 SC; addition of 0.14 % RME 500 EW; water rate 250 L/ha per m CH 

* before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) CH Canopy height 
- 263 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I d: Summary of trial information – Peach and apricot 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Northern Europe RA-2126/04 R 2004 0785/8 F-36300 Pouligny Saint Pierre, NFrance 

peach / Nerine 

1. 1990 2. 15.03.2004 3. 05.07. – 10.07.2004 

0.1800 0.1800 

1250 1250 

0.014 0.014 

04.06.2004 18.06.2004 

BBCH 77 fruit 

fruit fruit fruit 

0.51 0.10 0.07 0.07 

0.13 0.24 0.15 0.15 

0.053 0.041 0.029 0.032 

0.036 0.057 0.053 0.053 

0.009 0.013 0.012 0.012 

0.738 0.451 0.314 0.317 

0 

14 21 27 

formulation: 100 OD 

RA-2126/04 R 2004 0786/6 D-65366 Geisenheim, Germany 

apricot / Goldrich 

1. 15.11.1998 2. 17.03.2004 3. 30.06. – 14.07.2004 

0.1440 0.1440 

1000 1000 

0.014 0.014 

01.06.2004 15.06.2004 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

0.07 0.26 0.17 0.12 0.14 0.09 

0.074 0.094 

0.14 0.12 

0.095 0.077 

0.019 0.016 0.018 0.013 0.014 0.013 

0.012 0.012 0.012 0.012 0.012 0.012 

0.15 0.11 0.18 0.21 0.25 0.28 

0.325 0.492 0.520 0.475 0.511 0.472 

0* 

0 7 

14 21 28 

formulation: 100 OD 

RA-2006/05 R 2005 0059/9 D-06179 Höhnstedt, Germany 

apricot / Stark Early Orange 

1. 01.03.1997 2. 01.04.2005 3. 01.07. – 20.07.2005 

0.1800 0.1800 

1250 1250 

0.014 0.014 

09.06.2005 23.06.2005 

BBCH 78 fruit 

fruit fruit 

0.39 0.07 0.04 

0.25 0.37 0.29 

0.058 0.044 0.034 

0.012 0.012 0.012 

0.26 0.37 0.32 

0.970 0.866 0.696 

0 

14 21 

formulation: 150 OD 

RA-2006/05 R 2005 0060/2 D-65366 Geisenheim, Germany 

apricot / Goldrich 

1. 15.11.2000 2. 15.03.2005 3. 07.07. – 21.07.2005 

0.1440 0.1440 

600 600 

0.024 0.024 

08.06.2005 22.06.2005 

BBCH 75 fruit 

fruit fruit fruit fruit 

0.10 0.29 0.15 0.08 0.07 

0.085 0.092 

0.19 0.21 0.13 

0.012 0.012 0.014 0.016 0.018 

0.012 0.012 0.012 0.012 0.012 

0.082 0.086 

0.17 0.24 0.29 

0.291 0.492 0.536 0.558 0.520 

0* 

0 7 

14 21 

formulation: 150 OD; water rate 300 L/ha per m CH 

RA-2006/05 R 2005 0061/0 F-36300 Pouligny Saint Pierre, NFrance 

peach / Nerine 

1. 01.02.1992 2. 15.03.2005 3. 04.07. – 15.07.2005 

0.1800 0.1800 

1250 1250 

0.014 0.014 

02.06.2005 16.06.2005 

BBCH 78 fruit 

fruit fruit fruit fruit fruit 

0.12 0.26 0.14 0.10 0.06 0.04 

0.080 0.088 

0.25 0.24 0.25 0.18 

0.032 0.032 0.042 0.033 0.035 0.027 

0.012 0.012 0.062 0.074 0.083 0.065 

<0.008 <0.008 

0.008 0.009 0.010 0.009 

0.252 0.400 0.502 0.456 0.438 0.321 

0* 

0 7 

14 21 27 

formulation: 150 OD 
- 264 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Southern Europe RA-2127/04 R 2004 0787/4 E-08784 La Fortesa, Spain 

peach / Ruby Rich 

1. 1996 2. 22.03.2004 3. 23.06. – 28.06.2004 

0.1800 0.1800 

1250 1250 

0.014 0.014 

18.05.2004 01.06.2004 

BBCH 76 fruit 

fruit fruit fruit 

0.48 0.08 0.04 0.02 

0.23 0.28 0.19 0.13 

0.057 0.037 0.027 0.020 

0.03 

0.092 0.081 0.087 

0.008 0.008 0.008 0.008 

0.805 0.497 0.346 0.265 

0 

14 22 27 

formulation: 100 OD 

RA-2127/04 R 2004 0788/2 I-40128 Bologna, Italy 

apricot / Bella d’Imola 

1. 10.11.2001 2. 01.03.2004 3. 26.06. – 02.07.2004 

0.1800 0.1800 

1250 1250 

0.014 0.014 

25.05.2004 08.06.2004 

BBCH 77 fruit 

fruit fruit fruit 

0.42 0.08 0.07 0.04 

0.27 0.23 0.14 

0.086 

0.041 

0.03 

0.023 0.020 

0.012 0.014 0.016 0.015 

0.22 0.37 0.43 0.40 

0.963 0.724 0.679 0.561 

0 

14 21 28 

formulation: 100 OD 

RA-2127/04 R 2004 0789/0 I-48100 Ravenna, Italy 

peach / Red Haven 

1. 30.11.1997 2. 15.03.2004 3. 10.07. – 31.07.2004 

0.1800 0.1800 

1250 1250 

0.014 0.014 

16.06.2004 30.06.2004 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

0.08 0.33 0.15 0.05 0.03 0.01 

0.048 0.068 

0.12 0.10 

0.071 0.044 

0.044 0.046 0.050 0.034 0.017 0.012 

0.023 0.028 0.039 0.040 0.044 0.039 

0.008 0.009 0.009 0.008 0.008 0.008 

0.203 0.481 0.368 0.232 0.170 0.113 

0* 

0 7 

14 21 28 

formulation: 100 OD 

RA-2127/04 R 2004 0790/4 E-46840 Pobla del Duc, Spain 

apricot / Canino 

1. 2000 2. 15.02.2004 3. 05.06. – 20.06.2004 

0.1296 0.1296 

900 900 

0.014 0.014 

27.04.2004 13.05.2004 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

0.01 0.16 0.07 0.04 0.02 0.02 

0.048 0.074 0.093 0.099 

0.13 

0.091 

0.012 0.022 0.023 0.015 0.014 0.012 

<0.012 <0.012 <0.012 <0.012 

0.012 0.012 

0.036 0.050 0.073 0.077 

0.11 0.12 

0.118 0.318 0.271 0.243 0.286 0.255 

0* 

0 7 

14 21 28 

formulation: 100 OD 

RA-2007/05 R 2005 0062/9 P-2580-555 Mato, Portugal 

apricot / Canino 

1. 15.01.1997 2. 02.04.2005 3. 10.06. – 11.06.2005 

0.1440 0.1440 

1000 1000 

0.014 0.014 

13.04.2005 27.04.2005 

BBCH 75 fruit 

fruit fruit fruit 

0.61 0.21 0.09 0.10 

0.40 0.30 0.16 0.11 

0.094 0.097 0.085 0.050 

0.012 0.012 0.012 0.012 

0.12 0.34 0.34 0.33 

1.236 0.959 0.687 0.602 

0 

14 21 28 

formulation: 150 OD 

RA-2007/05 R 2005 0063/7 E-08784 La Fortesa, Spain 

peach / Richlady 

1. 15.01.1993 2. 25.03.2005 3. 05.07. – 10.07.2005 

0.1607 0.1728 

1116 1200 

0.014 0.014 

27.05.2005 10.06.2005 

BBCH 75 fruit 

fruit fruit fruit 

0.35 0.19 0.09 0.06 

0.062 

0.15 

0.093 0.071 

0.034 0.048 0.016 0.012 

0.020 0.097 

0.10 0.11 

0.008 0.008 0.008 0.008 

0.474 0.493 0.307 0.261 

0 

13 20 28 

formulation: 150 OD 

RA-2007/05 R 2005 0064/5 GR-20200 Souli Korinthias, Greece 

apricot / Bebekou 

1. 1994 2. 15.03.2005 3. 04.07. – 14.07.2005 

0.1728 0.1800 

1200 1250 

0.014 0.014 

31.05.2005 14.06.2005 

BBCH 75 fruit 

fruit fruit fruit 

0.25 0.15 0.05 0.05 

0.064 0.094 0.063 0.039 

0.012 0.012 0.012 0.012 

<0.012 <0.012 

0.012 

<0.012 

0.046 

0.10 

0.099 

0.10 

0.384 0.368 0.236 0.213 

0 

14 21 28 

formulation: 150 OD 
- 265 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2007/05 R 2005 0065/3 F-84200 Montfavet, SFrance 

peach / Spring white 

1. 10.03.1998 2. 15.03.2005 3. 12.06. – 28.06.2005 

0.1728 0.1800 

1200 1250 

0.014 0.014 

11.05.2005 25.05.2005 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

0.04 0.22 0.09 0.05 0.03 0.02 

0.037 0.061 

0.11 

0.071 0.047 0.054 

0.022 0.022 0.023 0.014 0.012 0.012 

0.012 0.012 0.019 0.022 0.018 0.019 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.119 0.323 

0.25 

0.165 0.115 0.113 

0* 

0 7 

14 21 28 

formulation: 150 OD 

RA-2007/05 R 2005 0066/1 I-40128 Bologna, Italy 

apricot / Bella di Imola 

1. 10.11.2001 2. 01.03.2005 3. 28.06. – 02.07.2005 

0.1800 0.1800 

1250 1250 

0.014 0.014 

24.05.2005 07.06.2005 

BBCH 79 fruit 

fruit fruit fruit fruit fruit 

0.04 0.12 0.05 0.03 0.02 0.02 

0.058 0.079 

0.14 0.10 

0.061 0.040 

0.012 0.014 0.015 0.012 0.012 0.013 

<0.012 

0.012 0.012 0.012 0.012 0.012 

0.064 0.074 0.099 

0.11 0.17 0.16 

0.186 0.299 0.316 0.264 0.275 0.245 

0* 

0 7 

14 21 27 

formulation: 150 OD 

* before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) CH Canopy height 
- 266 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I e: Summary of trial information – Plum 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Northern Europe RA-2124/04 R 2004 0774/2 D-04808 WurzenRoitzsch, Germany 

plum / Cacaks Schöne 

1. 01.10.1989 2. 20.04.2004 3. 01.08. – 10.09.2004 

0.216 0.216 

1500 1500 

0.014 0.014 

14.07.2004 28.07.2004 

BBCH 81 fruit 

fruit fruit fruit 

0.20 0.08 0.05 0.04 

0.31 0.45 0.32 0.29 

0.027 0.041 0.031 0.038 

0.086 

0.25 0.25 0.33 

0.034 

0.11 0.10 0.13 

0.657 0.931 0.751 0.828 

0 

14 21 28 

formulation: 100 OD 

RA-2124/04 R 2004 0775/0 D-51399 Burscheid, Germany 

plum / Cacaks Fruchtbare 

1. 01.03.1993 2. 18.04.2004 3. 01.08. – 15.08.2004 

0.144 0.144 

1000 1000 

0.014 0.014 

29.06.2004 13.07.2004 

BBCH 75 fruit 

fruit fruit fruit 

0.16 0.02 0.01 0.01 

0.071 0.061 0.034 0.015 

0.012 0.012 0.012 0.012 

0.031 0.072 0.078 0.084 

0.008 0.020 0.025 0.024 

0.282 0.185 0.159 0.145 

0 

14 21 28 

formulation: 100 OD 

RA-2124/04 R 2004 0776/9 F-36300 Pouligny St. Pierre, NFrance 

plum / Opale 

1. 1984 2. 30.03.2004 3. 15.07. – 26.07.2004 

0.180 0.180 

1250 1250 

0.014 0.014 

14.06.2004 28.06.2004 

BBCH 77 fruit 

fruit fruit fruit fruit fruit 

0.08 0.37 0.16 0.09 0.07 0.06 

0.21 0.22 0.31 0.25 0.26 0.26 

0.027 0.029 0.029 0.025 0.025 0.028 

0.049 0.053 0.058 0.057 0.064 0.084 

0.05 

0.057 0.078 0.078 

0.11 0.15 

0.416 0.729 0.635 

0.5 

0.529 0.582 

0* 

0 7 

14 21 28 

formulation: 100 OD 

RA-2124/04 R 2004 0777/7 GB-CB4 5HG Cambridge, UK 

plum / Edwards 

1. 1994 2. 11.04.2004 3. 22.08. – 12.09.2004 

0.180 0.180 

1250 1250 

0.014 0.014 

28.07.2004 11.08.2004 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

0.07 0.25 0.14 0.10 0.09 0.07 

0.15 0.15 0.17 0.17 0.13 0.14 

0.012 0.012 0.012 0.015 0.014 0.017 

0.089 0.085 

0.11 0.13 0.15 0.20 

0.042 0.042 0.046 0.055 0.064 0.084 

0.363 0.539 0.478 

0.47 

0.448 0.511 

0* 

0 7 

14 21 28 

formulation: 100 OD 

RA-2004/05 R 2005 0050/5 GB-CB4 5HG Cambridge, UK 

plum / Edwards 

1. 1989 2. 18.04.2005 3. 19.08. – 09.09.2005 

0.180 0.180 

1250 1250 

0.014 0.014 

02.08.2005 16.08.2005 

BBCH 85 fruit 

fruit fruit fruit 

0.16 0.07 0.04 0.03 

0.092 

0.17 0.19 0.14 

0.012 0.012 0.012 0.012 

0.017 0.037 0.078 0.083 

0.008 0.015 0.033 0.034 

0.289 0.304 0.353 0.299 

0 

14 21 28 

formulation: 150 OD 
- 267 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2004/05 R 2005 0051/3 F-36300 Pouligny St. Pierre, France 

plum / Reine Claude Verte 

1. 1992 2. 01.04.2005 3. 22.07. – 04.08.2005 

0.144 0.144 

1000 1000 

0.014 0.014 

20.06.2005 04.07.2005 

BBCH 79 fruit 

fruit fruit fruit 

0.26 0.06 0.04 0.03 

0.09 

0.099 

0.11 

0.063 

0.012 0.012 0.012 0.012 

0.096 

0.21 0.23 0.19 

0.011 0.019 0.024 0.016 

0.469 0.400 0.416 0.311 

0 

14 21 28 

formulation: 150 OD 

RA-2004/05 R 2005 0052/1 D-40789 Monheim, Germany 

plum / Ersinger 

1. 01.04.1989 2. 20.04.2005 3. 01.07. – 15.08.2005 

0.216 0.216 

1500 1500 

0.014 0.014 

01.06.2005 15.06.2005 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

0.01 0.08 0.05 0.03 0.02 0.02 

0.023 0.044 0.095 0.062 0.027 0.043 

0.012 0.012 0.017 0.015 0.017 0.012 

0.012 0.012 0.062 

0.11 

0.098 

0.10 

<0.008 <0.008 

0.009 0.016 0.016 0.018 

0.065 0.156 0.233 0.233 0.178 0.193 

0* 

0 7 

14 21 28 

formulation: 150 OD 

RA-2004/05 R 2005 0054/8 D-04808 WurzenRoitzsch, Germany 

plum / Cacaks Schöne 

1. 01.10.1996 2. 15.04.2005 3. 01.08. – 05.09.2005 

0.216 0.216 

1500 1500 

0.014 0.014 

19.07.2005 02.08.2005 

BBCH 76 fruit 

fruit fruit fruit fruit fruit 

0.02 0.08 0.06 0.05 0.02 0.03 

0.039 0.052 0.082 0.074 0.041 0.043 

0.012 0.012 0.012 0.012 0.012 0.012 

0.014 0.017 0.019 0.021 0.018 0.022 

0.008 0.008 0.010 0.009 0.010 0.012 

0.093 0.169 0.183 0.166 0.101 0.119 

0* 

0 7 

14 21 28 

formulation: 150 OD 

Southern Europe RA-2125/04 R 2004 0778/5 F-31620 Fronton, SFrance 

plum / Bave 

1. 1994 2. 15.05.2004 3. 05.08. – 20.08.2004 

0.216 0.216 

1500 1500 

0.014 0.014 

08.07.2004 22.07.2004 

BBCH 79 fruit 

fruit fruit fruit 

0.15 0.09 0.06 0.05 

0.12 0.19 0.16 0.11 

0.013 0.021 0.021 

0.02 

0.073 

0.19 

0.2 

0.22 

0.022 0.043 0.044 0.044 

0.378 0.534 0.485 0.444 

0 

14 21 28 

formulation: 100 OD 

RA-2125/04 R 2004 0779/3 I-48100 Ravenna, Italy 

plum / Goccia d`Oro 

1. 2001 2. 01.04.2004 3. 05.07. – 26.07.2004 

0.180 0.180 

1250 1250 

0.014 0.014 

14.06.2004 28.06.2004 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

0.03 0.21 0.11 0.04 0.03 0.02 

0.093 0.096 

0.18 0.15 

0.092 

0.06 

0.014 0.018 0.018 0.016 0.013 0.012 

0.012 0.012 0.014 

0.02 

0.023 0.029 

0.009 0.009 0.014 0.021 0.023 0.028 

0.158 0.345 0.336 0.247 0.181 0.149 

0* 

0 7 

14 21 28 

formulation: 100 OD 

RA-2005/05 R 2005 0055/6 I-41058 Viglona, Italy 

plum / President 

1. 15.01.2001 2. 28.03.2005 3. 20.08. – 10.09.2005 

0.144 0.144 

1000 1000 

0.014 0.014 

21.07.2005 04.08.2005 

BBCH 79 fruit 

fruit fruit fruit 

0.34 0.09 0.08 0.03 

0.055 

0.12 

0.088 0.037 

0.012 0.012 0.012 0.012 

0.054 

0.13 0.17 0.15 

0.018 

0.04 

0.045 0.036 

0.479 0.392 0.3950.265 

0 

14 21 28 

formulation: 150 OD 
- 268 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2005/05 R 2005 0058/0 E-46840 Pobla del Duc, Spain 

plum / Black Gold 

1. 01.02.1992 2. 20.02.2005 3. 10.07. – 20.07.2005 

0.144 0.144 

1000 1000 

0.014 0.014 

06.06.2005 20.06.2005 

BBCH 77 fruit 

fruit fruit fruit fruit fruit 

0.03 0.12 0.11 0.07 0.05 0.03 

0.036 0.047 0.063 0.054 0.044 0.025 

0.012 0.012 0.012 0.012 0.012 0.012 

0.012 0.012 0.012 0.018 0.021 0.021 

<0.008 

0.008 0.008 0.008 0.008 0.009 

0.09 

0.199 0.205 0.162 0.135 0.097 

0* 

0 7 

14 21 28 

formulation: 150 OD 

 * before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) CH Canopy height 
- 269 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I f: Summary of trial information – Cherry 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 1. Sowing or planting 2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Northern Europe RA-2119/04 R 2004 0718/1 F-36300 Pouligny Saint Pierre, NFrance 

sweet cherry / Garnet 

1. 1993 2. 05.04.2004 3. 14.06. – 18.06.2004 

0.144 0.144 

1000 1000 

0.014 0.014 

11.05.2004 25.05.2004 

BBCH 75 fruit 

fruit fruit fruit fruit 

0.09 0.43 0.02 0.01 0.01 

0.15 0.25 0.32 0.32 0.23 

0.18 0.21 0.19 0.11 

0.089 

0.024 0.026 0.081 

0.12 0.13 

0.008 0.008 0.018 0.023 0.026 

0.452 0.924 0.629 0.583 0.485 

0* 

0 

14 21 28 

formulation: 100 OD 

RA-2119/04 R 2004 0720/3 D-04808 Wurzen Roitzsch, Germany 

sour cherry / Fanal 

1. 10.03.1988 2. 05.05.2004 3. 01.08. – 20.08.2004 

0.180 0.180 

1250 1250 

0.014 0.014 

08.06.2004 22.06.2004 

BBCH 78 fruit 

fruit fruit fruit fruit 

0.12 0.56 0.03 0.01 0.01 

0.20 0.25 0.25 0.21 0.12 

0.10 0.10 0.06 

0.033 0.024 

0.018 0.017 0.021 0.021 0.022 

0.017 0.014 0.013 0.011 0.013 

0.455 0.941 0.374 0.285 0.189 

0* 

0 

14 21 28 

formulation: 100 OD 

RA-2119/04 R 2004 0721/1 F-49800 Brain sur L’Authion, N-France 

sweet cherry / 

Hedelfingen

1. 1998 2. 26.04.2004 3. 01,07. – 30,07.2004 

0.144 0.144 

1000 1000 

0.014 0.014 

04.06.2004 18.06.2004 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

0.03 0.39 0.03 0.03 0.02 0.01 

0.70 0.63 0.79 0.86 0.58 0.39 

0.11 

0.098 0.087 

0.11 

0.072 0.055 

0.069 0.057 0.093 

0.17 0.17 0.11 

0.054 0.047 0.057 

0.11 

0.097 0.065 

0.963 1.222 1.057 1.280 0.939 0.630 

0* 

0 7 

13 21 27 

formulation: 100 OD 

RA-2119/04 R 2004 0723/8 D-51399 Burscheid, Germany 

sour cherry / Schattenmorelle 

1. 01.03.1999 2. 30.04.2004 3. 01.07. – 20.08.2004 

0.144 0.144 

1000 1000 

0.014 0.014 

22.06.2004 06.07.2004 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

0.01 0.51 0.02 0.01 0.01 

<0.01 

0.099 

0.17 0.41 0.29 0.21 0.13 

0.013 0.014 0.018 0.016 0.012 0.012 

0.012 0.012 0.019 0.030 0.040 0.041 

0.008 0.008 0.011 0.016 0.023 0.020 

0.142 0.714 0.478 0.362 0.295 0.213 

0* 

0 7 

14 21 28 

formulation: 100 OD 

RA-2008/05 R 2005 0068/8 D-04808 Wurzen Roitzsch, Germany 

sweet cherry / 

Kordia

1. 01.03.1996 2. 12.04.2005 3. 05.07. – 20.07.2005 

0.216 0.216 

1500 1500 

0.014 0.014 

14.06.2005 28.06.2005 

BBCH 81 fruit 

fruit fruit 

0.69 0.03 0.02 

0.26 0.53 0.36 

0.052 

0.13 0.13 

0.074 

0.17 0.23 

0.018 0.057 0.086 

1.094 0.917 0.826 

0 

14 21 

formulation: 150 OD 
- 270 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 1. Sowing or planting 2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2008/05 R 2005 0071/8 F-36300 Pouligny Saint Pierre, NFrance 

sweet cherry / 

Garnet

1. 01.01.1992 2. 01.04.2005 3. 16.06. – 17.06.2005 

0.144 0.144 

1000 1000 

0.014 0.014 

12.05.2005 26.05.2005 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

0.03 0.28 0.04 0.02 0.01 0.01 

0.092 

0.27 0.44 0.31 0.23 0.19 

0.072 0.090 

0.12 

0.082 0.068 0.067 

0.012 0.012 0.049 0.059 0.091 

0.21 

0.008 0.008 0.011 0.013 0.018 0.047 

0.214 0.660 0.660 0.484 0.417 0.524 

0* 

0 7 

14 21 28 

formulation: 150 OD 

RA-2008/05 R 2005 0072/6 D-40789 Monheim, Germany 

sour cherry / Schattenmorelle 

1. 01.01.1992 2. 12.04.2005 3. 05.07. – 20.07.2005 

0.216 0.216 

1500 1500 

0.014 0.014 

01.06.2005 15.06.2005 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

0.02 0.31 0.10 0.02 

<0.01 <0.01 

0.041 

0.13 0.30 0.29 0.15 

0.093 

0.035 0.030 0.046 0.040 0.022 0.015 

0.012 0.012 0.033 0.054 0.037 0.038 

0.008 0.008 0.024 0.039 0.029 0.028 

0.116 

0.49 

0.503 0.443 0.248 0.184 

0* 

0 7 

14 21 28 

formulation: 150 OD 

Southern Europe RA-2118/04 R 2004 0716/5 I-70052 Bisceglie, Italy 

sweet cherry / Lapins 01 

1. 1994 2. 05.04.2004 3. 02.06. – 22.06.2004 

0.144 0.144 

1000 1000 

0.014 0.014 

28.04.2004 12.05.2004 

BBCH 75 fruit 

fruit fruit fruit fruit

0.04 0.25 0.04 0.01 

<0.01 

0.18 0.22 0.48 0.38 0.24 

0.22 0.23 0.19 0.11 

0.085 

0.029 0.027 0.067 

0.11 0.10 

0.008 0.008 0.018 0.019 0.019 

0.477 0.735 0.795 0.629 0.454 

0* 

0 

14 21 28 

formulation: 100 OD 

RA-2118/04 R 2004 0717/3 F-84170 Monteux, SFrance 

sweet cherry / Belge 

1. 01.10.1999 2. 01.04.2004 3. 08.06. – 22.06.2004 

0.1584 0.1620 

1100 1125 

0.014 0.014 

11.05.2004 25.05.2004 

BBCH 78 fruit 

fruit fruit fruit fruit fruit

0.05 0.43 0.07 0.06 0.05 0.02 

0.18 0.28 0.52 0.50 0.50 0.35 

0.12 0.12 0.14 0.11 0.11 

0.086 

0.024 0.022 

0.11 0.21 0.32 0.37 

0.008 0.008 0.021 0.038 0.065 0.071 

0.382 

0.86 

0.861 0.918 1.045 0.897 

0* 

0 9 

14 21 28 

formulation: 100 OD 

RA-2009/05 R 2005 0073/4 I-70031 Andria, Italy 

sweet cherry / Ferrovia 

1. 11.02.1997 2. 15.04.2005 3. 10.06. – 10.07.2005 

0.216 0.216 

1500 1500 

0.014 0.014 

23.05.2005 06.06.2005 

BBCH 85 fruit 

fruit fruit fruit 

0.29 0.02 0.01 0.01 

0.77 0.57 0.35 0.26 

0.093 0.099 0.055 0.044 

0.54 0.39 0.22 0.14 

0.11 

0.073 0.044 0.027 

1.803 1.152 0.679 0.481 

0 

14 21 28 

formulation: 150 OD 
- 271 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 1. Sowing or planting 2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2009/05 R 2005 0074/2 E-08690 Santa Coloma de Cervelló, Spain 

sweet cherry / Venus 

1. 15.01.1990 2. 05.04.2005 3. 15.06. – 20.06.2005 

0.1944 0.1944 

1350 1350 

0.014 0.014 

10.05.2005 24.05.2005 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

0.01 0.34 0.12 0.09 0.06 0.05 

0.29 0.41 0.47 0.32 0.22 0.10 

0.072 0.072 0.076 0.075 0.073 0.076 

0.083 0.092 

0.20 0.30 0.29 0.33 

0.017 0.019 0.042 0.069 0.078 0.095 

0.472 0.933 0.908 0.854 0.721 0.651 

0* 

0 7 

14 21 28

formulation: 150 OD 

* before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) 
- 272 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I g: Summary of trial information – Grapes 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 1. Sowing or planting 2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Southern Europe RA-2049/04 R 2004 0196/5 I-40128 Bologna, Italy 

grape / 

Chardonnay

1. 11.02.1991 2. 01.06.2004 3. 10.08. – 20.08.2004 

0.096 0.096 

1500 1500 

0.0064

0.0064

23.07.2004 06.08.2004 

BBCH 85 bunch 

bunch bunch bunch berry bunch berry bunch berry 

0.03 0.37 0.14 0.15 0.14 0.17 0.12 0.12 0.08 

0.040 

0.10 0.11 0.17 0.15 

0.095 0.092 0.059 0.041 

0.060 0.078 0.047 0.095 0.085 

0.10 

0.072 0.074 0.060 

0.012 0.012 0.012 0.012 0.012 0.012 0.012 0.012 0.012 

0.041 0.042 0.031 

0.11 0.10 0.16 0.18 0.16 0.16 

0.183 0.602 0.340 0.537 0.487 0.537 0.476 0.425 0.353 

0* 

0 3 7 7 

14 14 21 21 

formulation: 100 OD 

RA-2049/04 R 2004 0197/3 I-41030 San Prospero, Italy 

grape / 

Lambrusco di Sorbara

1. 10.01.1996 2. 28.05.2004 3. 15.09. – 10.10.2004 

0.096 0.096 

1500 1500 

0.0064

0.0064

23.08.2004 06.09.2004 

BBCH 83 bunch 

bunch bunch berry bunch berry bunch berry 

0.14 0.20 0.20 0.17 0.03 0.06 0.03 0.03 

0.030 0.042 0.045 0.037 0.022 0.035 0.022 0.022 

0.025 0.027 0.045 0.031 0.020 0.038 0.024 0.020 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.020 0.018 0.026 0.026 0.019 0.038 0.030 0.030 

0.227 0.299 0.328 0.276 0.103 0.183 0.118 0.114 

0* 

0 7 7 

14 14 21 21 

formulation: 100 OD 

RA-2049/04 R 2004 0198/1 GR-20006 Korinthos, Greece 

table grape / Soultanina 

1. 10.03.1993 2. 15.05.2004 3. 20.08. – 10.09.2004 

0.096 0.096 

1500 1500 

0.0064

0.0064

10.08.2004 24.08.2004 

BBCH 85 bunch 

berry bunch berry bunch berry bunch berry bunch berry bunch berry 

0.05 0.05 0.17 0.14 0.15 0.12 0.15 0.16 0.08 0.08 0.10 0.08 

0.064 0.066 0.092 0.089 0.096 0.081 

0.11 0.11 0.11 0.11 0.11 0.11 

0.012 0.012 0.015 0.012 0.015 0.013 0.018 0.018 0.012 0.013 0.016 0.014 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.022 0.023 0.023 0.025 0.027 0.025 0.033 0.037 0.043 0.045 0.054 0.051 

0.16 

0.163 0.312 0.278 0.300 0.251 0.323 0.337 0.257 0.260 0.292 0.267 

0* 0* 

0 0 3 3 7 7 

14 14 21 21 

formulation: 100 OD 
- 273 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 1. Sowing or planting 2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2049/04 R 2004 0201/5 E-30550 Cieza, Spain 

table grape / Napoleon 

1. 01.01.1992 2. 15.04.2004 3. 15.09. – 10.12.2004 

0.096 0.096 

1500 1500 

0.0064

0.0064

14.09.2004 28.09.2004 

BBCH 85 bunch 

berry bunch berry bunch berry bunch berry bunch berry bunch berry 

0.22 0.22 0.32 0.52 0.45 0.49 0.37 0.30 0.20 0.47 0.21 0.33 

0.030 0.031 0.035 0.050 0.044 0.040 0.039 0.027 0.021 0.047 0.018 0.031 

0.033 0.032 0.022 0.034 0.049 0.050 0.040 0.025 0.024 0.054 0.021 0.035 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.028 0.028 0.017 0.027 0.033 0.031 0.029 0.022 0.027 0.058 0.030 0.054 

0.323 0.323 0.406 0.643 0.588 0.623 0.490 0.386 0.284 0.641 0.291 0.462 

0* 0* 

0 0 3 3 7 7 

15 15 21 21 

formulation: 100 OD 

RA-2049/04 R 2004 0202/3 F-31340 Vacquiers, SFrance 

table grape / Chasselas 

1. 01.01.1950 2. 01.06.2004 3. 15.09. – 30.09.2004 

0.096 0.096 

1500 1500 

0.0064

0.0064

19.08.2004 02.09.2004 

BBCH 85 bunch 

berry bunch berry bunch berry bunch berry bunch berry 

0.07 0.06 0.19 0.18 0.10 0.09 0.11 0.13 0.09 0.09 

0.033 0.030 0.041 0.034 0.037 0.032 0.044 0.055 0.040 0.038 

0.012 0.012 0.012 0.012 0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.012 

<0.012 <0.012 

0.023 0.020 0.024 0.024 0.032 0.033 0.063 0.074 0.062 0.063 

0.15 

0.134 0.279 0.262 0.193 0.179 0.241 0.283 0.216 0.215 

0* 0* 

0 0 7 7 

14 14 21 21 

formulation: 100 OD 

RA-2049/04 R 2004 0203/1 GR-57011 Anchialos, Greece 

table grape / Moschato 

1. 10.02.1995 2. 05.06.2004 3. 20.08. – 20.09.2004 

0.096 0.096 

1500 1500 

0.0064

0.0064

09.08.2004 23.08.2004 

BBCH 85 bunch 

berry bunch berry bunch berry bunch berry bunch berry 

0.03 0.10 0.14 0.09 0.15 0.11 0.05 0.15 0.05 0.02 

0.024 0.043 0.023 0.043 0.057 0.045 0.042 0.022 0.034 0.022 

0.012 0.020 0.012 0.017 0.018 0.014 0.012 0.012 0.013 0.012 

<0.012 

0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.028 0.093 0.027 0.082 0.060 0.036 0.040 0.022 0.043 0.031 

0.106 0.268 0.214 0.244 0.297 0.217 0.156 0.218 0.152 0.097 

0* 0* 

0 0 7 7 

14 14 21 21 

formulation: 100 OD 
- 274 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 1. Sowing or planting 2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2034/05 R 2005 0157/9 E-46340 Campo Arcis, Spain 

grape / 

Tempranillo

1. 01.01.1999 2. 15.06.2005 3. 15.09. – 30.09.2005 

0.096 0.096 

800 800 

0.0120

0.0120

30.08.2005 13.09.2005 

BBCH 85 bunch 

bunch 

bunch bunch berry bunch berry bunch berry 

0.09 0.39 0.32 0.09 0.11 0.09 0.07 0.07 0.06 

0.029 0.038 0.030 0.030 0.034 0.027 0.031 0.022 0.024 

0.013 

<0.012 

0.014 0.017 0.014 0.019 0.019 0.018 0.019 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.015 0.011 0.013 0.017 0.022 0.031 0.035 0.029 0.030 

0.159 0.463 0.389 0.166 0.192 0.179 0.167 0.151 0.145 

0* 

0 3 7 7 

14 14 21 21 

formulation: 150 OD 

RA-2034/05 R 2005 0157/9 I-40128 Bologna, Italy 

grape / 

Chardonnay

1. 01.02.1995 2. 15.05.2005 3. 01.08. – 10.08.2005 

0.096 0.096 

1000 1000 

0.0096

0.0096

12.07.2005 26.07.2005 

BBCH 79 bunch 

bunch bunch bunch berry bunch berry bunch berry 

0.14 0.34 0.19 0.11 0.19 0.13 0.16 0.05 0.03 

0.062 0.057 

0.12 0.22 0.20 0.17 0.21 0.14 0.12 

0.027 0.022 0.026 0.028 0.040 0.035 0.041 0.034 0.029 

<0.012 <0.012 <0.012 

0.014 0.016 

<0.012 <0.012 

0.014 

<0.012 

0.040 0.036 0.039 0.082 

0.11 0.13 0.15 0.15 0.15 

0.281 0.467 0.387 0.454 0.556 0.477 0.573 0.388 0.341 

0* 

0 3 7 7 

14 14 21 21 

formulation: 150 OD 

RA-2036/05 R 2005 0161/7 F-86380 Vendeuvre du Poitou, SFrance 

grape / Chenin 

1. 01.03.1979 2. 01.06.2005 3. 05.10. – 15.10.2005 

0.096 0.096 

160 160 

0.0600

0.0600

07.09.2005 21.09.2005 

BBCH 85 bunch 

bunch berry bunch berry bunch berry 

0.21 0.20 0.14 0.17 0.16 0.14 0.12 

<0.012 

0.012 

<0.012 

0.015 

<0.012 

0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 

0.009 0.011 0.008 0.015 0.017 

0.254 0.244 0.185 

0.22 

0.204 0.191 0.173 

0 7 7 

14 14 21 21 

formulation: 048 SC 

RA-2036/05 R 2005 0162/5 I-40128 Bologna, Italy 

grape / 

Chardonnay

1. 01.02.1995 2. 15.05.2005 3. 01.08. – 10.08.2005 

0.096 0.096 

1000 1000 

0.0096

0.0096

13.07.2005 27.07.2005 

BBCH 79 bunch 

bunch berry bunch berry bunch berry 

0.11 0.08 0.08 0.10 0.07 0.03 0.03 

0.027 

0.13 0.14 0.14 0.15 

0.099 

0.10 

<0.012 

0.019 0.015 0.026 0.021 0.018 0.018 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.014 0.052 0.063 0.084 0.095 

0.11 0.11 

0.175 0.293 

0.31 

0.362 0.348 0.269 0.270 

0 7 7 

14 14 21 21 

formulation: 048 SC 

* before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) 
- 275 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I h: Summary of trial information – Strawberry 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Greenhouse trials RA-2122/04 R 2004 0726/2 D-46397 Bocholt, Germany 

strawberry / Elsanta 

1. 01.08.2003 2. 20.03.2004 3. 01.05. – 01.06.2004 

0.096 0.096 

1000 1000 

0.0096

0.0096

21.04.2004 05.05.2004 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

0.01 0.04 0.03 0.01 0.01 0.01 

0.13 0.16 0.19 0.19 0.24 0.18 

0.012 0.014 0.013 0.012 0.012 0.015 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.008 0.011 

0.172 0.234 0.253 0.232 0.282 0.228 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2122/04 R 2004 0765/3 D-46397 Bocholt, Germany 

strawberry / Dar. Selekt 

1. 01.08.2003 2. 20.03.2004 3. 01.05. – 01.06.2004 

0.096 0.096 

1000 1000 

0.0096

0.0096

05.05.2004 19.05.2004 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

0.01 0.04 0.01 0.01 0.01 0.01 

0.16 0.22 0.13 0.16 0.15 0.14 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 

0.012 

0.018 0.022 0.014 0.011 0.010 0.019 

0.212 0.306 0.178 0.205 0.194 0.193 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2122/04 R 2004 0766/1 D-53332 BornheimSechtem, Germany 

strawberry / Nenci 

1. 26.07.2003 2. 10.04.2004 3. 12.05. – 10.06.2004 

0.102 0.096 

668 700 

0.0137

0.0153

26.04.2004 10.05.2004 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

0.01 0.08 0.06 0.04 0.03 0.02 

0.062 

0.11 0.15 0.16 0.16 

0.071 

0.012 0.013 0.014 0.014 0.016 0.014 

<0.012 <0.012 <0.012 <0.012 

0.012 0.012 

0.008 0.009 0.009 0.013 0.026 0.030 

0.104 0.224 0.245 0.239 0.244 0.147 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2122/04 R 2004 0768/8 F-82370 Reynies, France 

strawberry / Gariguette 

1. 25.06.2003 2. 20.02.2004 3. 15.04.2004 

0.096 0.096 

1000 1000 

0.0096

0.0096

30.03.2004 13.04.2004 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

0.01 0.04 0.02 0.02 0.01 0.01 

0.12 0.14 0.14 0.22 0.28 0.27 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 

0.012 

0.008 0.008 0.008 0.013 0.014 0.021 

0.162 0.212 0.192 0.277 0.328 0.325 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2122/04 R 2004 0769/6 D-48291 TelgteWestbevern, Germany 

strawberry / Elsanta 

1. 01.08.2003 2. 20.03.2004 3. 01.05. – 01.06.2004 

0.096 0.096 

1000 1000 

0.0096

0.0096

21.04.2004 05.05.2004 

BBCH 85 fruit 

fruit fruit fruit fruit 

0.03 0.12 0.04 0.03 0.05 

0.11 0.16 0.16 0.11 0.21 

0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.008 

0.172 0.312 0.232 0.172 0.292 

0* 0 1 3 7 

formulation: 100 OD 
- 276 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2122/04 R 2004 0771/8 D-48291 TelgteWestbevern, Germany 

strawberry / Dar. Selekt 

1. 01.08.2003 2. 20.03.2004 3. 01.05. – 01.06.2004 

0.096 0.096 

1000 1000 

0.0096

0.0096

21.04.2004 05.05.2004 

BBCH 85 fruit 

fruit fruit fruit fruit 

0.02 0.11 0.06 0.04 0.03 

0.075 

0.14 0.18 0.16 0.13 

0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.009 0.009 0.010 0.009 

0.127 0.283 0.273 0.234 0.193 

0* 0 1 3 7 

formulation: 100 OD 

RA-2122/04 R 2004 0772/6 D-VechtaLangförden, Germany 

strawberry / Elsanta 

1. 22.01.2004 2. 22.03.2004 3. 10.05. – 09.06.2004 

0.096 0.096 

600 600 

0.0160

0.0160

30.04.2004 14.05.2004 

BBCH 85 fruit 

fruit fruit fruit fruit 

0.04 0.13 0.11 0.08 0.08

0.15 0.18 0.21 0.17 0.14

0.012 0.012 0.012 0.012 0.012

<0.012 <0.012 <0.012 <0.012 <0.012

0.008 0.008 0.008 0.008 0.008

0.222 0.342 0.352 0.282 0.252

0* 0 1 3 7 

formulation: 100 OD 

RA-2122/04 R 2004 0773/4 F-84200 Carpentras, France 

strawberry / Pajaro 

1. 05.08.2003 2. 15.03.2004 3. 15.04. – 15.06.2004 

0.096 0.096 

600 600 

0.0160

0.0160

20.04.2004 04.05.2004 

BBCH 85 fruit 

fruit fruit fruit fruit 

0.01 0.03 0.02 0.02 0.02

0.18 0.22 0.23 0.25 0.21

0.012 0.013 0.013 0.013 0.013

0.012 0.012 0.012 0.012 0.012

0.008 0.008 0.008 0.008 0.009

0.222 0.283 0.283 0.303 0.264

0* 0 1 3 7 

formulation: 100 OD 

Field conditions – Northern Europe RA-2120/04 R 2004 0724/6 D-46397 Bocholt, Germany 

strawberry / Titania 

1. 01.08.2003 2. 25.04.2004 3. 28.05. – 20.07.2004 

0.096 0.096 

1000 1000 

0.0096

0.0096

01.06.2004 15.06.2004 

BBCH 87 fruit 

fruit fruit fruit fruit fruit 

0.01 0.01 0.01 0.01 0.01 

<0.01 

0.14 

0.064 0.084 

0.12 0.14 

0.060 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.008 0.008 

0.182 0.106 0.126 0.162 0.182 0.102 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2120/04 R 2004 0759/9 D-48291 TelgteWestbevern, Germany 

strawberry / Dar. Selekt 

1. 10.07.2003 2. 15.05. – 10.06.2004 3. NA 

0.096 0.096 

1000 1000 

0.0096

0.0096

01.06.2004 15.06.2004 

BBCH 87 fruit 

fruit fruit fruit fruit fruit 

<0.01 

0.02 0.01 0.01 0.01 

<0.01 

0.039 0.033 0.050 0.088 

0.12 

0.049 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.008 0.008 

0.081 0.085 0.092 0.130 0.162 0.091 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2120/04 R 2004 0760/2 F-80700 Cremery, NFrance 

strawberry / Eros 

1. 15.01.2004 2. 25.05.2004 3. 02.06. – 07.07.2004 

0.096 0.096 

600 600 

0.0160

0.0160

25.05.2004 08.06.2004 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

0.01 0.05 0.02 0.02 0.01 0.01 

0.083 

0.11 0.16 0.20 0.19 0.14 

0.012 0.012 0.012 0.012 0.014 0.019 

<0.012 <0.012 <0.012 <0.012 <0.012 

0.012 

0.013 0.014 0.016 0.014 0.025 0.033 

0.130 0.198 0.220 0.258 0.251 0.214 

0* 0 1 3 7 14 

formulation: 100 OD 
- 277 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2120/04 R 2004 0761/0 F-80700 Glisolles, NFrance 

strawberry / Mara des Bois 

1. 18.03.2002 2. 10.05.2004 3. 26.06. – 05.07.2004 

0.096 0.096 

600 600 

0.0160

0.0160

14.06.2004 28.06.2004 

BBCH 87 fruit 

fruit fruit fruit fruit fruit 

<0.01 

0.14 0.08 0.07 0.02 0.01 

<0.012 

0.086 0.078 

0.11 0.12 

0.060 

<0.012 <0.012 <0.012 

0.012 0.012 0.013 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 

0.008 0.008 0.008 0.009 0.012 

0.054 0.258 0.19 0.212 0.173 0.107 

0* 0 1 3 7 14 

formulation: 100 OD 

Field conditions – Southern Europe RA-2121/04 R 2004 0725/4 I-44046 San Martino, Italy 

strawberry / 

Marmolada

1. 10.08.2003 2. 15.04.2004 3. 10.05. – 30.05.2004 

0.096 0.096 

600 600 

0.0160

0.0160

03.05.2004 17.05.2004 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

<0.01 

0.04 0.02 0.02 0.01 

<0.01 

<0.012 

0.020 0.050 0.080 0.075 0.029 

<0.012 <0.012 

0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 

0.012 

<0.012 

<0.008 <0.008 

0.008 0.012 0.034 0.020 

0.054 0.092 0.102 0.136 0.143 0.083 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2121/04 R 2004 0762/9 I-40026 Imola, Italy 

strawberry / Madelaine

1. 01.08.2003 2. 05.04.2004 3. 10.05. – 30.05.2004 

0.096 0.096 

600 600 

0.0160

0.0160

26.04.2004 10.05.2004 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

<0.01 

0.05 0.02 0.01 

<0.01 

0.01 

0.037 0.070 0.080 

0.11 

0.066 0.042 

0.012 0.015 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 

0.008 

<0.008 

0.008 0.008 0.014 

0.079 0.155 0.132 0.152 0.108 0.09 

0* 0 1 3 7 14 

formulation: 100 OD 

RA-2121/04 R 2004 0763/7 E-08396 Sant Cebrià de Vallalta, Spain 

strawberry / Aromas

1. 05.04.2004 2. 05.06.2004 3. 30.06. – 15.12.2004 

0.096 0.096 

800 800 

0.0120

0.0120

06.07.2004 20.07.2004 

BBCH 87 fruit 

fruit fruit fruit fruit 

0.01 0.03 0.03 0.02 0.01 

0.021 0.060 0.089 0.090 0.069 

0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.009 

0.063 0.122 0.151 0.143 0.114 

0* 0 1 3 7 

formulation: 100 OD 

RA-2121/04 R 2004 0764/5 F-69690 Courzieu, SFrance 

strawberry / Mara des Bois 

1. 13.04.2004 2. 01.07.2004 3. 01.08. – 25.10.2004 

0.096 0.096 

700 700 

0.0137

0.0137

27.09.2004 11.10.2004 

BBCH 89 fruit 

fruit fruit fruit fruit fruit 

0.01 0.10 0.06 0.02 0.01 0.02 

0.052 0.058 0.049 0.061 0.019 0.012 

0.012 0.015 0.015 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.011 0.011 0.012 0.008 0.008 0.008 

0.097 0.197 0.144 0.113 0.061 0.054 

0* 0 1 3 7 15 

formulation: 100 OD 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) NA not applicable* before the last treatment 
- 278 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I i: Summary of trial information – Onion 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Field conditions – Northern Europe RA-2131/04 R 2004 0854/4D-40764 Langenfeld, Germany 

Onion Stuttgarter Riesen 

1. 29.03.2004 3. 15.08.2004 - 15.09.2004 

0.072 0.072 0.072 0.072 

600 600 600 600 

0.0120

0.01200.01200.0120

14.07.2004 21.07.2004 28.07.2004 04.08.2004 

BBCH 48 bulb 

bulb bulb bulb 

0.04 <0.01 <0.01 <0.01 

0.16 0.16 0.051 0.060 

<0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 

0.232 0.202 0.093 0.102 

0 7 14 21 

formulation: 100 OD 

RA-2131/04 R 2004 0855/2 F-80700 Champien, France 

Onion Bugati 

1. 01.04.2004 3. 28.09.2004  - 30.09.2004 

0.0720 0.0720 0.0720 0.0720 

400 400 400 400 

0.0180

0.01800.01800.0180

18.08.2004 25.08.2004 01.09.2004 08.09.2004 

BBCH 48 bulb 

bulb bulb bulb 

0.03 <0.01 <0.01 <0.01 

0.061 0.055 0.045 0.052 

<0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 

0.123 0.097 0.087 0.094 

0 7 14 21 

formulation: 100 OD 

RA-2131/04 R 2004 0856/0 D-41379 Brüggen, Germany 

Onion Copra F1 

1. 05.03.2004 3. 20.08.2004 - 31.08.2004 

0.0720 0.0720 0.0720 0.0720 

500 500 500 500 

0.0144

0.01440.01440.0144

15.07.2004 22.07.2004 29.07.2004 05.08.2004 

BBCH 48 bulb 

bulb bulb bulb bulb bulb 

0.01 0.04 0.02 <0.01 <0.01 <0.01 

0.061 0.063 0.066 0.055 0.066 0.067 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.103 0.135 0.118 0.097 0.108 0.109 

0 0 4 7 14 21 

formulation: 100 OD 

RA-2131/04 R 2004 0857/9 F-78680 Epone, France 

Onion Nirvana 

1. 11.02.2004 3. 02.09.2004 

0.0720 0.0720 0.0720 0.0720 

400 400 400 400 

0.0180

0.01800.01800.0180

23.07.2004 30.07.2004 06.08.2004 13.08.2004 

BBCH 47 bulb 

bulb bulb bulb bulb bulb 

<0.01 0.01 <0.01 <0.01 <0.01 <0.01 

0.047 0.052 0.052 0.071 0.058 0.052 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.089 0.094 0.094 0.113 0.100 0.094 

0 0 3 7 14 21 

formulation: 100 OD 

RA-2040/05 R 2005 0212/5 GB-ip24 3tq thetford, United Kingdom 

Onion Red Barron 

1. 14.03.2005 3. 15.08.2005  - 31.08.2005 

0.0720 0.0720 0.0720 0.0720 

300 300 300 300 

0.0240

0.02400.02400.0240

25.07.2005 02.08.2005 08.08.2005 15.08.2005 

BBCH 47 bulb 

bulb 

0.01 <0.01 

0.11 0.12 

<0.012 <0.012 

<0.012 <0.012 

<0.008 <0.008 

0.152 0.162 

0 8 

formulation: 150 OD 
- 279 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2040/05 R 2005 0214/1 F-80700 Champien, France 

Onion BOSTON 

1. 26.03.2005 3. 23.09.2005  - 29.09.2005 

0.0720 0.0720 0.0720 0.0720 

300 300 300 300 

0.0240

0.02400.02400.0240

29.08.2005 05.09.2005 12.09.2005 19.09.2005 

BBCH 49 bulb 

bulb 

0.02 0.01 

<0.012 <0.012 

<0.012 <0.012 

<0.012 <0.012 

<0.008 <0.008 

0.064 <0.054 

0 7

formulation: 150 OD 

RA-2040/05 R 2005 0216/8 D-40764 LangenfeldReusrath, Germany 

Onion Stuttgarter Riesen 

1. 26.03.2005 3. 16.08.2005 

0.0720 0.0720 0.0720 0.0720 

300 300 300 300 

0.0240

0.02400.02400.0240

19.07.2005 26.07.2005 02.08.2005 09.08.2005 

BBCH 48 bulb 

bulb bulb bulb bulb bulb 

<0.01 0.01 <0.01 <0.01 <0.01 <0.01 

0.042 0.043 0.042 0.042 0.041 0.038 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.084 0.085 0.084 0.084 0.083 0.080 

0 0 3 714 21 

formulation: 150 OD 

RA-2040/05 R 2005 0217/6 D-53332 Bornheim, Germany 

Onion Sumit 

1. 20.04.2005 3. 21.08.2005  - 25.08.2005 

0.0720 0.0720 0.0720 0.0720 

400 400 400 400 

0.0180

0.01800.01800.0180

11.07.2005 18.07.2005 25.07.2005 01.08.2005 

BBCH 47 bulb 

bulb bulb bulb bulb bulb 

<0.01 0.04 0.01 <0.01 <0.01 <0.01 

0.020 0.038 0.040 0.050 0.040 0.031 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.062 0.110 0.082 0.092 0.082 0.073 

0 0 3 715 21 

formulation: 150 OD 

Field conditions – Southern Europe RA-2132/04 R 2004 0858/7 F-69380 Chazay d'Azergues, France 

Onion Stuttgart 

1. 15.04.2004 3. 12.08.2004  - 02.09.2004 

0.0720 0.0720 0.0720 0.0720 

500 500 500 500 

0.0144

0.01440.01440.0144

22.07.2004 29.07.2004 05.08.2004 12.08.2004 

BBCH 48 bulb 

bulb bulb bulb 

<0.01 <0.01 <0.01 <0.01 

0.040 0.021 0.024 0.022 

<0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 

0.082 0.063 0.066 0.064 

0 7 14 21 

formulation: 100 OD 

RA-2132/04 R 2004 0859/5 GR-32200 Thiva, Greece 

Onion Amposta 

1. 20.03.2004 3. 05.08.2004  - 08.08.2004 

0.0720 0.0720 0.0720 0.0720 

600 600 600 600 

0.0120

0.01200.01200.0120

30.06.2004 07.07.2004 14.07.2004 21.07.2004 

BBCH 48 bulb 

bulb bulb bulb 

<0.01 <0.01 <0.01 <0.01 

0.064 0.081 0.061 0.055 

<0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 

0.106 0.123 0.103 0.097 

0 714 21 

formulation: 100 OD 

RA-2132/04 R 2004 0860/9 I-40128 Bologna, Italy 

Onion Density 

1. 22.04.2004 3. 10.08.2004  - 25.08.2004 

0.0720 0.0720 0.0720 0.0720 

400 400 400 400 

0.0180

0.01800.01800.0180

16.07.2004 23.07.2004 30.07.2004 06.08.2004 

BBCH 47 bulb 

bulb bulb bulb bulb bulb 

0.02 0.02 <0.01 <0.01 <0.01 <0.01 

0.042 0.038 0.050 0.052 0.052 0.056 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.094 0.090 0.092 0.094 0.094 0.098 

0 0 3 7 14 21 

formulation: 100 OD 
- 280 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2132/04 R 2004 0861/7 E-46230 Alginet, Spain 

Onion Babosa 

1. 26.01.2004 3. 25.05.2004  - 25.06.2004 

0.0720 0.0720 0.0720 0.0720 

500 500 500 500 

0.0144

0.01440.01440.0144

27.04.2004 04.05.2004 12.05.2004 18.05.2004 

BBCH 47 bulb 

bulb bulb bulb bulb bulb 

<0.01 0.01 <0.01 <0.01 <0.01 <0.01 

0.090 0.083 0.11 0.13 0.12 0.11 

<0.012 <0.012 <0.012 0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.132 0.125 0.152 0.172 0.162 0.152 

0 0 3 714 21 

formulation: 100 OD 

RA-2041/05 R 2005 0225/7 I-44012 Settepolesini, Italy 

Onion Dorata di Parma 

1. 27.02.2005 3. 20.07.2005  - 15.08.2005 

0.0720 0.0720 0.0720 0.0720 

600 600 600 600 

0.0120

0.01200.01200.0120

04.07.2005 11.07.2005 18.07.2005 25.07.2005 

BBCH 48 bulb 

bulb 

<0.01 <0.01 

0.030 0.034 

<0.012 <0.012 

<0.012 <0.012 

<0.008 <0.008 

0.072 0.076 

0 7

formulation: 150 OD 

RA-2041/05 R 2005 0226/5 E-08380 Malgrat de Mar, Spain 

Onion Alabaster 

1. 01.08.2005 3. 14.11.2005  - 30.11.2005 

0.0720 0.0720 0.0777 0.0720 

500 500 646 600 

0.0144

0.01440.01200.0120

24.10.2005 02.11.2005 08.11.2005 16.11.2005 

BBCH 47 bulb 

bulb 

0.02 0.02 

0.032 0.037 

<0.012 0.017 

<0.012 <0.012 

<0.008 <0.008 

0.084 0.094 

0 7

formulation: 150 OD 

RA-2041/05 R 2005 0227/3 F-31790 Saint Jory , France 

Onion Elody 

1. 13.07.2005 3. 24.09.2005  - 01.10.2005 

0.0720 0.0720 0.0720 0.0720 

600 600 600 600 

0.0120

0.01200.01200.0120

24.08.2005 31.08.2005 06.09.2005 13.09.2005 

BBCH 45 bulb 

bulb bulb bulb bulb bulb 

<0.01 0.01 0.01 <0.01 <0.01 <0.01 

0.037 0.051 0.14 0.10 0.050 0.034 

<0.012 0.015 <0.012 0.013 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.079 0.096 0.182 0.143 0.092 0.076 

0 0 3 714 21 

formulation: 150 OD 

RA-2041/05 R 2005 0228/1 E-46230 Alginet, Spain 

Onion Liria 

1. 18.03.2005 3. 01.06.2005  - 01.08.2005 

0.0720 0.0720 0.0720 0.0720 

500 500 500 500 

0.0144

0.01440.01440.0144

14.06.2005 21.06.2005 28.06.2005 05.07.2005 

BBCH 48 bulb 

bulb bulb bulb bulb bulb 

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 <0.054 <0.054 <0.054 <0.054 <0.054 

0 0 3 714 21 

formulation: 150 OD 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) NA not applicable 
- 281 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I j: Summary of trial information – tomato 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Greenhouse trials RA-2139/04 R 2004 0823/4 I-70054 Giovinazzo, Italy 

cherry tomato, Shiren 

1. 02.08.2004 2. 25.08.2004 3. 20.10.2004  - 10.12.2004 

0.1440 0.1440 0.1440 0.1440

1600 1600 1600 1600 

0.00900.00900.00900.0090

12.10.2004 19.10.2004 26.10.2004 02.11.2004 

BBCH 83 fruit 

fruit fruit fruit fruit fruit 

0.12 0.25 0.11 0.09 0.11 0.05 

0.20 0.21 0.19 0.18 0.17 0.16 

0.065 0.056 0.040 0.039 0.050 0.032 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.080 0.084 0.082 0.096 0.10 0.11 

0.477 0.612 0.434 0.417 0.442 0.364 

0* 0 1 3 4 8 

formulation 100 OD 

RA-2139/04 R 2004 0824/2 I-70056 Molfetta (Bari), Italy 

cherry tomato, Shiren 

1. 10.07.2004 2. 01.08.2004 3. 27.09.2004  - 10.12.2004

0.1440 0.1440 0.1440 0.1440 

1600 1600 1600 1600 

0.00900.00900.00900.0090

22.09.2004 29.09.2004 06.10.2004 13.10.2004 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

0.12 0.19 0.10 0.04 0.16 0.14 

0.16 0.14 0.17 0.17 0.16 0.15 

0.019 0.019 0.014 0.012 0.022 0.020 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.065 0.059 0.062 0.061 0.082 0.094 

0.376 0.420 0.358 0.295 0.436 0.416 

0* 0 1 3 4 8 

formulation 100 OD 

RA-2139/04 R 2004 0825/0 E-18127 Jayena Granada, Spain 

cherry tomato, Josefina 

1. 15.05.2004 2. 02.06.2004 3. 01.07.2004  - 30.10.2004 

0.1584 0.1440 0.1656 0.1440 

1760 1600 1840 1600 

0.0090

0.00900.00900.0090

20.07.2004 27.07.2004 03.08.2004 09.08.2004 

BBCH 82 fruit 

fruit fruit fruit fruit fruit 

0.18 0.39 0.24 0.22 0.25 0.25 

0.22 0.27 0.23 0.25 0.24 0.21 

0.013 0.017 0.016 0.022 0.021 0.024 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.15 0.17 0.15 0.17 0.18 0.24 

0.575 0.859 0.648 0.674 0.703 0.736 

0* 0 1 3 5 7 

formulation 100 OD 3rd appl. 15% overdosed 

RA-2139/04 R 2004 0826/9 E-18127 Fornes Granada, Spain 

cherry tomato, Josefina 

1. 13.05.2004 2. 02.06.2004 3. 01.07.2004  - 30.10.2004 

0.1584 0.1440 0.1440 0.1440 

1760 1600 1600 1600 

0.0090

0.00900.00900.0090

20.07.2004 27.07.2004 03.08.2004 09.08.2004 

BBCH 82 fruit 

fruit fruit fruit fruit fruit 

0.23 0.27 0.22 0.25 0.16 0.16 

0.22 0.21 0.20 0.23 0.23 0.21 

0.044 0.037 0.033 0.045 0.036 0.034 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.12 0.11 0.12 0.14 0.14 0.19 

0.626 0.639 0.585 0.677 0.578 0.606 

0* 0 1 3 5 7 

formulation 100 OD 

RA-2140/04 R 2004 0827/7 GR-57006 Vasilica, Greece 

Tomato Beatrice 

1. 03.08.2004 2. 09.08.2004 3. 26.10.2004  - 30.11.2004 

0.1080 0.1080 0.1166 0.1188 

1125 1125 1215 1238 

0.0096

0.00960.00960.0096

28.09.2004 05.10.2004 12.10.2004 19.10.2004 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

0.04 0.05 0.04 0.06 0.03 0.03 

0.11 0.11 0.19 0.39 0.23 0.18 

0.012 0.012 0.012 0.021 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.026 0.019 0.021 0.031 0.028 0.030 

0.200 0.203 0.275 0.514 0.312 0.264 

0* 0 1 3 5 8 

formulation 100 OD 
- 282 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2140/04 R 2004 0828/5 E-41720 Los Palacios Sevilla, Spain 

Tomato Genaro 

1. 20.12.2003 2. 05.01.2004 3. 01.04.2004  - 30.06.2004 

0.1152 0.1152 0.1152 0.1152 

1600 1600 1600 1600 

0.0072

0.00720.00720.0072

05.05.2004 12.05.2004 18.05.2004 25.05.2004 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

0.09 0.10 0.10 0.09 0.04 0.09 

0.077 0.078 0.093 0.10 0.081 0.099 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.039 0.040 0.042 0.043 0.048 0.078 

0.230 0.242 0.259 0.257 0.193 0.291 

0* 0 1 3 6 7 

formulation 100 OD 

RA-2140/04 R 2004 0829/3 E-08014 Viladecans, Spain 

Tomato Monica 

1. 06.02.2004 2. 10.03.2004 3. 01.04.2004  - 20.07.2004 

0.1440 0.1340 0.1440 0.1440 

1500 1395 1500 1500 

0.0096

0.00960.00960.0096

14.06.2004 21.06.2004 28.06.2004 05.07.2004 

BBCH 87 fruit 

fruit fruit fruit fruit fruit 

0.11 0.13 0.14 0.15 0.15 0.14 

0.093 0.073 0.075 0.11 0.079 0.11 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.034 0.034 0.034 0.052 0.039 0.062 

0.261 0.261 0.273 0.336 0.292 0.336 

0* 0 1 3 4 7 

formulation 100 OD 

RA-2140/04 R 2004 0830/7 I-97019 Vittoria (RG), Italy 

Tomato Vorian 

1. 16.04.2004 2. 18.05.2004 3. 08.07.2004 

0.1044 0.1152 0.1260 0.1440 

1450 1200 1313 1500 

0.0072

0.00960.00960.0096

09.06.2004 16.06.2004 23.06.2004 30.06.2004 

BBCH 72 fruit 

fruit fruit fruit fruit fruit 

0.03 0.06 0.06 0.07 0.03 0.03 

0.070 0.073 0.079 0.093 0.084 0.095 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.020 0.021 0.021 0.028 0.035 0.040 

0.144 0.178 0.184 0.215 0.173 0.189 

0* 0 1 3 5 7 

formulation 100 OD 

Field conditions – Southern EuropeRA-2130/04 R 2004 0849/8 E-08901 L'Hospitalet de Llobregat, Spain 

Tomato Sirena 

1. 25.05.2004 2. 20.06.2004 3. 10.08.2004  - 20.09.2004 

0.0720 0.0720 0.0720 0.0720 

750 750 750 750 

0.0096

0.00960.00960.0096

27.07.2004 05.08.2004 11.08.2004 17.08.2004 

BBCH 81 fruit 

fruit fruit fruit fruit 

0.04 0.02 0.04 0.03 0.01 

0.045 0.058 0.088 0.092 0.075 

0.012 <0.012 0.012 0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 

0.018 0.023 0.036 0.041 0.041 

0.127 0.125 0.188 0.187 0.150 

0 3 6 7 13 

formulation 100 OD 

RA-2130/04 R 2004 0850/1 P-2140-472 Vale de Cavalos, Portugal 

Tomato H-9553 

1. 08.04.2004 2. 08.05.2004 3. 14.08.2004  - 15.08.2004 

0.0720 0.0720 0.0720 0.0720 

750 750 750 750 

0.0096

0.00960.00960.0096

29.06.2004 07.07.2004 13.07.2004 20.07.2004 

BBCH 86 fruit 

fruit fruit fruit fruit 

0.06 0.04 0.03 0.02 0.01 

0.056 0.061 0.057 0.059 0.048 

0.012 0.012 0.012 0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 

0.018 0.019 0.026 0.026 0.030 

0.158 0.144 0.137 0.129 0.112 

0 3 5 7 14 

formulation 100 OD 
- 283 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2130/04 R 2004 0852/8 GR-32001 Petra, Greece 

Tomato 8892 F1 

1. 29.04.2004 2. 10.07.2004 3. 25.08.2004  - 05.09.2004 

0.0720 0.0720 0.0720 0.0720 

750 750 750 750 

0.0096

0.00960.00960.0096

26.07.2004 02.08.2004 09.08.2004 17.08.2004 

BBCH 84 fruit 

fruit fruit fruit fruit fruit fruit 

0.01 0.05 0.04 0.02 0.02 0.02 0.01 

0.035 0.057 0.057 0.038 0.045 0.041 0.034 

0.012 0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.017 0.024 0.024 0.023 0.031 0.026 0.038 

0.086 0.155 0.145 0.105 0.120 0.111 0.106 

0* 0 1 3 5 7 14 

formulation 100 OD 

RA-2130/04 R 2004 0853/6 I-71030 Zapponeta (Fg), Italy 

Tomato 

Perfectpeel 

1. 21.05.2004 2. 20.06.2004 3. 10.08.2004  - 10.09.2004 

0.0720 0.0720 0.0720 0.0720 

750 750 750 750 

0.0096

0.00960.00960.0096

21.07.2004 28.07.2004 04.08.2004 11.08.2004 

BBCH 81 fruit 

fruit fruit fruit fruit fruit fruit 

0.01 0.03 0.03 0.03 0.03 0.04 0.04 

0.13 0.13 0.12 0.13 0.11 0.065 0.074 

0.012 0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.012 0.013 0.015 0.025 0.023 0.022 0.042 

0.176 0.197 0.189 0.209 0.187 0.151 0.180 

0* 0 1 3 5 7 14 

formulation 100 OD 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) NA not applicable 
- 284 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I k: Summary of trial information – pepper 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Greenhouse trials RA-2026/04 R 2004 0113/2 NL-1704 PJ Heerhugowaard, Netherlands 

Pepper, sweet Ferrari 

1. 15.10.2003 2. 15.02.2004 3. 15.03.2004 

0.1224 0.1296 0.1332 0.1368 

1700 1800 1850 1900 

0.0072

0.00720.00720.0072

21.04.2004 28.04.2004 05.05.2004 12.05.2004 

BBCH 82 fruit 

fruit fruit fruit fruit fruit 

0.05 0.10 0.07 0.08 0.05 0.04 

0.35 0.38 0.40 0.41 0.39 0.46 

0.021 0.021 0.024 0.024 0.022 0.027 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.016 0.017 0.018 0.021 0.023 0.026 

0.449 0.530 0.524 0.547 0.497 0.565 

0* 0 1 3 5 7 

formulation 100 OD CH: 1.6-1.9 m 

RA-2026/04 R 2004 0114/0 D-42799 Leichlingen, Germany 

Pepper, sweet Mazurka 

1. 28.05.2004 2. 01.06.2004 3. 01.08.2004  - 30.09.2004 

0.0432 0.0432 0.0504 0.0576 

450 450 525 600 

0.0096

0.00960.00960.0096

12.07.2004 19.07.2004 26.07.2004 02.08.2004 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

0.06 0.11 0.09 0.07 0.07 0.04 

0.39 0.36 0.39 0.38 0.40 0.46 

0.021 0.021 0.021 0.022 0.025 0.021 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.054 0.044 0.053 0.048 0.053 0.048 

0.537 0.547 0.566 0.532 0.560 0.581 

0* 0 1 3 4 7 

formulation 100 OD CH: 0.6-0.8 m 

RA-2026/04 R 2004 0115/9 0115-04 F-13690 Graveson, SFrance 

Pepper, sweet Galileo 

1. 30.03.2004 2. 10.05.2004 3. 10.06.2004  - 15.10.2004 

0.0504 0.0540 0.0576 0.0684 

750 800 850 950 

0.0067

0.00680.00680.0072

26.05.2004 01.06.2004 07.06.2004 14.06.2004 

BBCH 69 fruit 

fruit fruit fruit fruit fruit 

0.03 0.07 0.06 0.05 0.04 0.04 

0.25 0.29 0.28 0.31 0.32 0.29 

0.024 0.041 0.028 0.027 0.029 0.025 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.019 0.022 0.020 0.022 0.025 0.025 

0.335 0.435 0.400 0.421 0.426 0.392

0* 0 1 3 5 7 

formulation 100 OD CH: 0.74-0.97 m 

RA-2026/04 R 2004 0116/7 P-2000-618 Póvoa da Isenta, Portugal 

Pepper, sweet Solero 

1. 15.03.2004 2. 01.05.2004 3. 08.06.2004 

0.0504 0.0576 0.0648 0.0720 

525 600 675 750 

0.0096

0.00960.00960.0096

18.05.2004 25.05.2004 01.06.2004 08.06.2004 

BBCH 78 fruit 

fruit fruit fruit fruit fruit 

0.03 0.06 0.03 0.03 0.04 0.02 

0.29 0.28 0.25 0.25 0.26 0.25 

0.027 0.030 0.026 0.019 0.023 0.019 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.013 0.013 0.014 0.014 0.016 0.018 

0.372 0.395 0.332 0.325 0.351 0.319 

0* 0 1 3 6 7 

formulation 100 OD CH: 0.70-1.0 m 

RA-2026/04 R 2004 0117/5 I-70056 Molfetta (Bari) (Puglia), Italy 

Pepper, sweet Sienor 

1. 23.02.2004 2. 20.04.2004 3. 25.06.2004  - 10.08.2004 

0.1080 0.1080 0.1080 0.1080 

1125 1125 1125 1125 

0.0096

0.00960.00960.0096

11.06.2004 18.06.2004 25.06.2004 02.07.2004 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

0.08 0.14 0.08 0.12 0.08 0.13 

0.23 0.25 0.25 0.31 0.31 0.34 

0.015 0.017 0.015 0.021 0.019 0.025 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.019 0.023 0.020 0.027 0.030 0.039 

0.356 0.442 0.377 0.490 0.451 0.546 

0* 0 1 3 5 7 

formulation 100 OD CH: 1.0-1.1 m 
- 285 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2026/04 R 2004 0118/3 D-42799 Leichlingen, Germany 

Pepper, sweet Maratos 

1. 28.05.2004 2. 01.06.2004 3. 01.08.2004  - 30.09.2004 

0.0432 0.0432 0.0504 0.0576 

450 450 525 600 

0.0096

0.00960.00960.0096

12.07.2004 19.07.2004 26.07.2004 02.08.2004 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

0.05 0.11 0.08 0.07 0.05 0.05 

0.32 0.30 0.33 0.26 0.30 0.35 

0.018 0.016 0.019 0.015 0.019 0.018 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.052 0.036 0.040 0.039 0.046 0.050 

0.452 0.474 0.481 0.396 0.427 0.480 

0* 0 1 3 4 7 

formulation 100 OD CH: 0.6-0.8 m 

RA-2026/04 R 2004 0119/1 F-84210 Pernes les Fontaines, SFrance 

Pepper, sweet Volga 

1. 20.03.2004 2. 01.05.2004 3. 01.06.2004  - 15.10.2004 

0.0504 0.0540 0.0576 0.0612 

700 750 800 850 

0.0072

0.00720.00720.0072

17.05.2004 24.05.2004 01.06.2004 07.06.2004 

BBCH 68 fruit 

fruit fruit fruit fruit fruit 

0.02 0.03 0.03 0.03 0.01 0.02 

0.17 0.18 0.19 0.20 0.20 0.18 

0.014 0.017 0.017 0.016 0.017 0.015 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.010 0.010 0.010 0.010 0.013 0.013 

0.226 0.249 0.259 0.268 0.252 0.240 

0* 0 1 3 5 7 

formulation 100 OD CH: 0.69-0.87 m 

RA-2026/04 R 2004 0120/5 E-08301 Mataró, Spain 

Pepper, sweet Largo italianoPadua 

1. 06.03.2004 2. 10.04.2004 3. 09.06.2004  - 30.11.2004 

0.0936 0.1008 0.1080 0.1152 

1300 1400 1500 1600 

0.0072

0.00720.00720.0072

28.06.2004 05.07.2004 12.07.2004 19.07.2004 

BBCH 82 fruit 

fruit fruit fruit fruit fruit 

0.03 0.05 0.06 0.03 0.03 0.03 

0.37 0.38 0.42 0.38 0.42 0.43 

0.018 0.019 0.020 0.019 0.020 0.020 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.052 0.034 0.029 0.036 0.027 0.044 

0.482 0.495 0.541 0.477 0.509 0.536 

0* 0 1 3 4 7 

formulation 100 OD CH: 1.2-1.7 m 

RA-2134/04 R 2004 0791/2 F-13690 Graveson, SFrance 

Pepper, sweet Galileo 

1. 30.03.2004 2. 10.05.2004 3. 10.06.2004  - 15.10.2004 

0.0540 0.0576 0.0612 0.0684 

750 800 850 950 

0.0072

0.00720.00720.0072

26.05.2004 01.06.2004 07.06.2004 14.06.2004 

BBCH 69 fruit 

fruit fruit fruit fruit fruit 

0.03 0.06 0.06 0.06 0.05 0.04 

0.28 0.30 0.31 0.36 0.32 0.29 

0.029 0.028 0.032 0.025 0.028 0.029 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.022 0.023 0.021 0.026 0.028 0.029 

0.373 0.423 0.435 0.483 0.438 0.400 

0* 0 1 3 5 7 

formulation 240 CS CH: 0.75-0.95 m 

RA-2134/04 R 2004 0792/0 D-42799 Leichlingen, Germany 

Pepper, sweet Maratos 

1. 28.05.2004 2. 01.06.2004 3. 01.08.2004  - 30.09.2004 

0.0432 0.0432 0.0504 0.0576 

450 450 525 600 

0.0096

0.00960.00960.0096

12.07.2004 19.07.2004 26.07.2004 02.08.2004 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

0.09 0.18 0.13 0.12 0.12 0.12 

0.21 0.23 0.28 0.26 0.27 0.37 

0.013 0.015 0.016 0.016 0.017 0.021 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.026 0.027 0.033 0.038 0.031 0.051 

0.351 0.464 0.471 0.446 0.450 0.574 

0* 0 1 3 4 7 

formulation 240 CS CH: 0.6-0.8 m 
- 286 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2134/04 R 2004 0793/9 I-70056 Molfetta (Bari), Italy 

Pepper, sweet Sienor 

1. 23.02.2004 2. 20.04.2004 3. 25.06.2004  - 10.08.2004 

0.1080 0.1080 0.1080 0.1080 

1125 1125 1125 1125 

0.0096

0.00960.00960.0096

11.06.2004 18.06.2004 25.06.2004 02.07.2004 

BBCH 81 fruit 

fruit fruit fruit fruit fruit 

0.08 0.16 0.12 0.10 0.06 0.12 

0.10 0.11 0.11 0.13 0.13 0.15 

0.012 0.012 0.012 0.012 0.012 0.013 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.009 0.009 0.010 0.016 

0.212 0.302 0.263 0.263 0.224 0.311 

0* 0 1 3 5 7 

formulation 240 CS CH: 1.5 m 

RA-2134/04 R 2004 0794/7 P-2000-618 Póvoa da Isenta, Portugal 

Pepper, sweet Solero 

1. 15.03.2004 2. 15.04.2004 3. 15.05.2004  - 15.07.2004 

0.0504 0.0576 0.0648 0.0720 

525 600 675 750 

0.0096

0.00960.00960.0096

18.05.2004 25.05.2004 01.06.2004 08.06.2004 

BBCH 78 fruit 

fruit fruit fruit fruit fruit 

0.04 0.09 0.05 0.04 0.02 0.03 

0.20 0.20 0.21 0.21 0.18 0.19 

0.013 0.023 0.015 0.014 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.010 0.012 0.011 0.013 0.013 0.017 

0.275 0.337 0.298 0.289 0.237 0.260 

0* 0 1 3 6 7 

formulation 240 CS CH: 0.7-1.0 m 

Field conditions – Southern EuropeRA-2027/04 R 2004 0121/3 E-46230 Alginet, Spain 

Pepper, sweet Italico 

1. 29.04.2004 2. 20.05.2004 3. 10.06.2004  - 30.08.2004 

0.0720 0.0720 0.0720 0.0720 

600 600 600 800 

0.0120

0.01200.01200.0090

16.06.2004 23.06.2004 30.06.2004 06.07.2004 

BBCH 72 fruit 

fruit fruit fruit fruit fruit 

0.13 0.28 0.20 0.14 0.08 0.10 

0.51 0.51 0.55 0.54 0.51 0.48 

0.034 0.039 0.057 0.062 0.047 0.053 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.051 0.043 0.050 0.063 0.053 0.066 

0.737 0.884 0.869 0.817 0.702 0.711 

0* 0 1 3 6 7 

formulation 100 OD 

RA-2027/04 R 2004 0122/1 F-31 330 Le Burgaud, France 

Pepper, sweet Alby 

1. 17.05.2004 2. 10.06.2004 3. 01.08.2004  - 01.10.2004 

0.0720 0.0720 0.0789 0.0720 

750 750 823 750 

0.0096

0.00960.00960.0096

23.07.2004 30.07.2004 06.08.2004 13.08.2004 

BBCH 76 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.01 0.01 0.01 <0.01 <0.01 

0.19 0.19 0.15 0.21 0.18 0.21 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.016 0.014 0.013 0.019 0.017 0.022 

0.24 0.238 0.197 0.263 0.231 0.266 

0* 0 1 3 5 7 

formulation 100 OD 3rd application was 10% overdosed 

RA-2027/04 R 2004 0124/8 I-70054 Giovinazzo (Bari), Italy 

Pepper, sweet Comet 

1. 21.06.2004 2. 30.07.2004 3. 15.09.2004  - 31.10.2004 

0.0720 0.0720 0.0720 0.0720 

1000 1000 1000 1000 

0.0072

0.00720.00720.0072

07.09.2004 14.09.2004 21.09.2004 28.09.2004 

BBCH 74 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.01 0.01 0.01 <0.01 <0.01 

0.11 0.12 0.13 0.13 0.16 0.12 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.010 0.009 0.009 0.010 0.012 0.011 

0.154 0.163 0.173 0.174 0.206 0.165 

0* 0 1 3 5 7 

formulation 100 OD 
- 287 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2027/04 R 2004 0125/6 P-2120-193 Foros de Salvaterra, Portugal 

Pepper, sweet Claudio 

1. 02.05.2004 2. 10.06.2004 

0.0761 0.0720 0.0720 0.0720 

793 750 750 750 

0.0096

0.00960.00960.0096

25.06.2004 02.07.2004 09.07.2004 16.07.2004 

BBCH 77 fruit 

fruit fruit fruit fruit fruit 

0.02 0.04 0.04 0.02 0.02 0.02 

0.23 0.25 0.24 0.25 0.29 0.29 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.015 0.014 0.013 0.015 0.018 0.019 

0.289 0.328 0.317 0.309 0.352 0.353 

0* 0 1 3 5 7 

formulation 100 OD 1st application was 6 % overdosed 

RA-2039/05 R 2005 0200/1 I-70053 Canosa (Bari), Italy 

Pepper, sweet Topeto 

1. 02.06.2005 2. 01.07.2005 3. 15.08.2005  - 15.09.2005 

0.0720 0.0720 0.0720 0.0720 

800 800 800 800 

0.0090

0.00900.00900.0090

02.08.2005 09.08.2005 16.08.2005 23.08.2005 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

0.01 0.03 0.04 0.02 0.01 0.01 

0.058 0.048 0.049 0.052 0.067 0.092 

0.012 0.012 0.012 0.012 0.012 0.013 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.010 0.012 

0.100 0.110 0.121 0.104 0.111 0.139 

0* 0 1 3 5 7 

formulation 150 OD 

RA-2039/05 R 2005 0202/8 P-2140-427 CaniceiraVale de Cavalos, Portugal 

Pepper, sweet Torpedo 

1. 08.04.2005 2. 15.05.2005 3. 10.07.2005  - 30.09.2005 

0.0720 0.0720 0.0720 0.0720 

500 500 500 500 

0.0144

0.01440.01440.0144

13.06.2005 20.06.2005 27.06.2005 04.07.2005 

BBCH 77 fruit 

fruit fruit fruit fruit fruit 

0.01 0.03 0.01 0.01 0.01 0.01 

0.13 0.15 0.13 0.12 0.13 0.098 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.008 0.008 

0.172 0.212 0.172 0.162 0.172 0.140 

0* 0 1 3 5 7 

formulation 150 OD 

RA-2046/05 R 2005 0707/0 I-70053 Canosa di Puglia (Bari), Italy 

Pepper, sweet Topeto 

1. 02.06.2005 2. 01.07.2005 3. 15.08.2005  - 15.09.2005 

0.0720 0.0720 0.0720 0.0720 

800 800 800 800 

0.00900.0090

0.00900.0090

02.08.2005 09.08.2005 16.08.2005 23.08.2005 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

0.01 0.04 0.03 0.02 0.01 0.01 

0.043 0.050 0.044 0.053 0.047 0.069 

0.012 0.012 0.012 0.014 0.012 0.013 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.008 0.009 

0.085 0.122 0.106 0.107 0.089 0.113 

0* 0 1 3 5 7 

formulation 048 SC 

RA-2046/05 R 2005 0708/9 P-2140-427 Caniceira - Vale de Cavalos, Portugal 

Pepper, sweet Torpedo 

1. 08.04.2005 2. 15.05.2005 3. 10.07.2005  - 30.09.2005 

0.0720 0.0720 0.0720 0.0720 

500 500 500 500 

0.0144

0.01440.01440.0144

13.06.2005 20.06.2005 27.06.2005 04.07.2005 

BBCH 77 fruit 

fruit fruit fruit fruit fruit 

0.01 0.04 0.02 0.02 0.02 0.01 

0.089 0.11 0.096 0.12 0.11 0.11 

0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.008 0.008 

0.131 0.182 0.148 0.172 0.162 0.152 

0* 0 1 3 5 7 

formulation 048 SC 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) NA not applicable CH Height of leafy surface 
- 288 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I l: Summary of trial information – cucumber 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Greenhouse trials RA-2030/04 R 2004 0130/2 D-42799 Leichlingen, Germany 

Cucumber Escape 

1. 04.05.2004 2. 15.05.2004 3. 15.06.2004  - 15.08.2004 

0.1008 0.1296 0.1440 0.1440 

1050 1350 1500 1500 

0.00960.00960.00960.0096

28.05.2004 04.06.2004 11.06.2004 18.06.2004 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.02 0.02 0.02 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 0.017 0.017 0.023 0.013 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.069 0.069 0.075 0.055 <0.054 

0* 0 1 3 5 7 

formulation OD 100 CH: 1.4-2.0 m 

RA-2030/04 R 2004 0131/0 I-97017 Santa Croce Camerina, Italy 

Cucumber Solverde 

1. 06.09.2004 2. 20.09.2004 3. 11.10.2004  - 22.11.2004 

0.1440 0.1440 0.1440 0.1440 

1500 1500 1500 1500 

0.00960.00960.00960.0096

13.10.2004 20.10.2004 27.10.2004 03.11.2004 

BBCH 89 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.02 0.03 0.01 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 0.012 0.015 0.017 0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.064 0.077 0.059 <0.054 <0.054

0* 0 1 3 5 

7 

formulation OD 100 CH: 2.0 m 

RA-2030/04 R 2004 0132/9 E-08014 Viladecans, Spain 

Cucumber Fito Porto 

1. 05.03.2004 2. 01.04.2004 3. 25.04.2004  - 19.07.2004 

0.1152 0.1224 0.1368 0.1440 

1200 1275 1425 1500 

0.0096

0.00960.00960.0096

12.05.2004 19.05.2004 26.05.2004 02.06.2004 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.04 0.03 0.02 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 0.020 0.020 0.018 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.092 0.082 0.070 <0.054 <0.054

0* 0 1 3 5 7 

formulation OD 100 CH: 1.15-1.44 m 

RA-2030/04 R 2004 0133/7 GR-60100 Aronas, Greece 

Cucumber Luberon 

1. 30.06.2004 2. 15.07.2004 3. 05.08.2004  - 07.09.2004 

0.0360 0.0720 0.1080 0.1296 

375 750 1125 1350 

0.0096

0.00960.00960.0096

27.07.2004 03.08.2004 10.08.2004 17.08.2004 

BBCH 77 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.03 0.05 0.02 0.02 0.01 

<0.012 0.022 0.016 <0.012<0.012 <0.012 

<0.012 0.022 0.020 0.022 0.015 0.013 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.094 0.106 0.074 0.067 0.055 

0* 0 1 3 5 7 

formulation OD 100 CH: 0.5-1.8 m 

RA-2030/04 R 2004 0134/5 D-42799 Leichlingen, Germany 

Cucumber Indira 

1. 04.06.2004 2. 15.06.2004 3. 15.07.2004  - 15.09.2004 

0.1152 0.1440 0.1440 0.1440 

1200 1500 1500 1500 

0.0096

0.00960.00960.0096

25.06.2004 02.07.2004 09.07.2004 16.07.2004 

BBCH 75 fruit 

fruit fruit fruit fruit fruit 

0.02 0.05 0.05 0.03 0.02 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.019 0.024 0.019 0.015 0.020 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.071 0.106 0.101 0.077 0.072 <0.054

0* 0 1 3 5 7 

formulation OD 100 CH: 1.6-2.0 m 
- 289 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2030/04 R 2004 0135/3 I-70056 Molfetta (Bari), Italy 

Cucumber Locale di Polignano 

1. 17.03.2004 2. 10.04.2004 3. 20.05.2004  - 20.07.2004 

0.1440 0.1440 0.1440 0.1440 

1500 1500 1500 1500 

0.0096

0.00960.00960.0096

19.05.2004 26.05.2004 02.06.2004 09.06.2004 

BBCH 76 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.01 0.01 <0.01 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 0.026 0.015 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.068 0.057 <0.054 <0.054 <0.054

0* 0 1 3 5 7 

formulation OD 100 CH: 2.0 m 

RA-2030/04 R 2004 0136/1 E-04740 Roquetas de Mar, Spain 

Cucumber Caman 

1. 23.03.2004 2. 05.05.2004 3. 15.04.2004  - 30.06.2004 

0.1224 0.1440 0.1440 0.1440 

1275 1500 1500 1500 

0.0096

0.00960.00960.0096

18.05.2004 25.05.2004 01.06.2004 08.06.2004 

BBCH 74 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.02 <0.01 <0.01 <0.01 <0.01 

<0.012 0.019 0.012 <0.012 <0.012 <0.012 

0.013 0.038 0.039 0.015 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.055 0.097 0.081 0.057 <0.054 <0.054 

0* 0 1 3 6 7 

formulation OD 100 CH: 1.7-2.0 m 

RA-2030/04 R 2004 0138/8 GR-58300 Esovalta, Greece 

Cucumber Scotinos (Hybrid. 

1. 20.07.2004 2. 01.08.2004 3. 16.08.2004 

0.0360 0.0720 0.0864 0.1080 

375 750 900 1125 

0.0096

0.00960.00960.0096

02.08.2004 09.08.2004 16.08.2004 23.08.2004 

BBCH 74 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.04 0.01 <0.01 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 0.048 0.021 0.013 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.120 0.063 <0.054 <0.054 <0.054

0* 0 1 3 5 7 

formulation OD 100 CH: 0.5-1.5 m 

Field conditions – Southern EuropeRA-2028/04 R 2004 0126/4 E-41310 Brenes, Spain 

Cucumber Suso 

1 15.04.2004 2 15.05.2004 3 15.05.2004  - 15.07.2004 

0.0720 0.0720 0.0720 0.0720 

600 600 600 600 

0.0120

0.01200.01200.0120

26.05.2004 02.06.2004 08.06.2004 15.06.2004 

BBCH 85 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.04 0.02 0.02 0.01 0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 0.018 0.015 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.090 0.067 0.064 <0.054 <0.054 

0* 0 1 3 6 7 

formulation OD 100 

RA-2028/04 R 2004 0128/0 E-08380 Malgrat de Mar, Spain 

Cucumber Oporto 

1 23.06.2004 2 09.07.2004 3 02.08.2004  - 30.09.2004 

0.0720 0.0720 0.0720 0.0720 

800 900 1000 1000 

0.0090

0.00800.00720.0072

23.07.2004 28.07.2004 03.08.2004 10.08.2004 

BBCH 82 fruit 

fruit fruit fruit fruit fruit 

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012<0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 <0.054 <0.054 <0.054 <0.054 <0.054

0* 0 1 3 6 7 

formulation OD 100 
- 290 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2028/04 R 2004 0129 9 I-71030 Zapponeta Foggia, Italy 

Cucumber Marinda 

1 15.07.2004 2 01.08.2004 3 20.08.2004  - 20.09.2004 

0.0720 0.0720 0.0720 0.0720 

800 800 800 800 

0.0090

0.00900.00900.0090

06.08.2004 13.08.2004 20.08.2004 27.08.2004 

BBCH 89 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.02 0.01 <0.01 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 0.033 0.015 0.013 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.085 0.057 <0.054 <0.054 <0.054

0* 0 1 3 5 7 

formulation OD 100 

RA-2043/05 R 2005 0239/7 E-46230 Alginet, Spain 

Cucumber Raider 

1. 12.05.2005 2. 01.06.2005 3. 20.06.2005  - 10.08.2005 

0.0720 0.0720 0.0720 0.0720 

600 600 600 800 

0.0120

0.01200.01200.0090

14.06.2005 21.06.2005 28.06.2005 05.07.2005 

BBCH 73 fruit 

fruit fruit fruit fruit fruit 

<0.01 0.03 0.02 0.02 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.074 0.064 0.064 <0.054 <0.054 

0* 0 1 3 6 7 

formulation OD 150 

RA-2043/05 R 2005 0240/0 E-08380 Malgrat de Mar, Spain 

Cucumber Kenia 

1. 14.05.2005 2. 30.05.2005 3. 15.06.2005  - 30.08.2005 

0.0792 0.0720 0.0720 0.0720 

770 800 900 1000 

0.0104

0.00900.00800.0072

23.06.2005 01.07.2005 08.07.2005 15.07.2005 

BBCH 84 fruit 

fruit fruit fruit 

<0.01 <0.01 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 

<0.054 <0.054 <0.054 <0.054

0 3 5 7 

formulation OD 150 1st application 10% overdosed 

RA-2043/05 R 2005 0241/9 I-97019 Vittoria, Italy 

Cucumber Setman 

1. 30.06.2005 2. 15.07.2005 3. 15.08.2005  - 15.09.2005 

0.0720 0.0720 0.0720 0.0720 

600 600 800 800 

0.0120

0.01200.00900.0090

27.07.2005 03.08.2005 10.08.2005 17.08.2005 

BBCH 78 fruit 

fruit fruit fruit 

0.01 <0.01 <0.01 <0.01 

0.017 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 

0.059 <0.054 <0.054 <0.054 

0 3 5 7 

formulation OD 150 

RA-2043/05 R 2005 0715 1 I-71049 Zapponeta, Italy 

Cucumber Locale di Polignano 

1. 20.09.2005 2. 20.10.2005 3. 30.10.2005  - 30.12.2005 

0.0720 0.0720 0.0720 0.0720 

700 700 700 700 

0.0104

0.01040.01040.0104

27.10.2005 03.11.2005 10.11.2005 17.11.2005 

BBCH 88 fruit 

fruit fruit fruit fruit fruit 

0.03 0.06 0.07 0.06 0.05 0.03 

0.021 0.035 0.025 0.027 0.020 0.019 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.083 0.127 0.127 0.119 0.102 0.081

0* 0 1 3 5 7 

formulation OD 150 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) NA not applicable CH Height of leafy surface 
- 291 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I m: Summary of trial information – melon 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Greenhouse trialsRA-2128/04 R 2004 0836/6 I-70056 Molfetta, Italy 

Melon Incas 

1 15.03.2004 2 20.04.2004 3 15.06.2004  - 15.07.2004 

0.0720 0.0720 0.0720 0.0720 

800 800 800 800 

0.0090

0.00900.00900.0090

01.06.2004 08.06.2004 15.06.2004 22.06.2004 

BBCH 83 fruit 

fruit fruit fruit pulp peel fruit pulp peel fruit 

0.01 0.02 0.02 0.01 <0.01 0.05 0.02 <0.01 0.02 0.02 

<0.012 <0.012 <0.012 <0.012 <0.012 0.019 <0.012 <0.012 0.015 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.064 0.064 <0.054 <0.054 0.101 0.064 <0.054 0.067 0.064 

0* 0 1 3 3 3 5 5 5 7 

formulation: OD 100 

RA-2128/04 R 2004 0837/4 E-11540 Sanlucar de Bda (Monte Algaida), Spain 

Melon Primal 

1 26.04.2004 2 20.05.2004 3 30.06.2004  - 10.07.2004 

0.0720 0.0720 0.0720 0.0720 

1000 1000 1000 1000 

0.0072

0.00720.00720.0072

09.06.2004 16.06.2004 23.06.2004 29.06.2004 

BBCH 79 fruit 

fruit fruit fruit pulp peel fruit pulp peel fruit 

<0.01 0.02 0.02 <0.01 <0.01 0.01 <0.01 <0.01 0.02 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 0.021 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 0.015 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.064 0.064 <0.054 <0.054 <0.054 <0.054 <0.054 0.076<0.054 

0* 0 1 3 3 3 5 5 5 7 

formulation: OD 100 

RA-2128/04 R 2004 0838/2 F-84140 Montfavet, SFrance 

Melon Lunabel 

1 25.03.2004 2 15.04.2004 3 15.06.2004  - 05.07.2004 

0.0720 0.0720 0.0720 0.0720 

600 600 600 600 

0.0120

0.01200.01200.0120

27.05.2004 02.06.2004 09.06.2004 16.06.2004 

BBCH 82 fruit 

fruit fruit fruit pulp peel fruit pulp peel fruit 

<0.01 <0.01 <0.01 0.01 <0.01 0.02 <0.01 <0.01 0.02 <0.01 

<0.012 <0.012 <0.012 0.014 <0.012 0.027 <0.012 <0.012 0.024 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 <0.054 <0.054 0.056 <0.054 0.079 <0.054 <0.054 0.076 <0.054 

0* 0 1 3 3 3 6 6 6 7 

formulation: OD 100 
- 292 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2128/04 R 2004 0839/0 P-2560-014 Torres Vedras, Portugal 

Melon Galas 

1 02.04.2004 2 25.05.2004 3 07.07.2004  - 14.07.2004 

0.0720 0.0720 0.0720 0.0720 

1000 1000 1000 1000 

0.0072

0.00720.00720.0072

17.06.2004 24.06.2004 01.07.2004 08.07.2004 

BBCH 85 fruit 

fruit fruit fruit pulp peel fruit pulp peel fruit 

<0.01 0.01 0.01 0.01 <0.01 0.04 0.01 <0.01 0.03 0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 0.017 <0.012 <0.012 0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 0.015 0.012 <0.012 0.029 <0.012 <0.012 0.027 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 <0.054 0.057 <0.054 <0.054 0.106 <0.054 <0.054 0.089 <0.054 

0* 0 1 3 3 3 5 5 5 7 

formulation: OD 100 

RA-2128/04 R 2004 0840/4 0840-04 P-2565 Freiria, Portugal 

Melon Star King 

1 02.05.2004 2 25.05.2004 3 07.07.2004  - 14.07.2004 

0.0720 0.0720 0.0720 0.0720 

1000 1000 1000 1000 

0.0072

0.00720.00720.0072

09.06.2004 16.06.2004 23.06.2004 30.06.2004 

BBCH 81 fruit 

fruit fruit fruit pulp peel fruit pulp peel fruit 

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.01 <0.01 0.02 0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 0.012 <0.012 <0.012 0.020 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 <0.054 <0.054 <0.054 <0.054 <0.054 <0.054 <0.054 0.072 <0.054 

0* 0 1 3 3 3 5 5 5 7 

formulation: OD 100 

RA-2128/04 R 2004 0841/2 I-71043 Manfredonia (Fg), Italy 

Melon Drake 

1 07.04.2004 2 05.05.2004 3 04.07.2004  - 20.07.2004 

0.0720 0.0720 0.0720 0.0720 

1000 1000 1000 1000 

0.0072

0.00720.00720.0072

15.06.2004 22.06.2004 29.06.2004 06.07.2004 

BBCH 81 fruit 

fruit fruit fruit pulp peel fruit pulp peel fruit 

<0.01 <0.01 <0.01 <0.01 <0.01 0.01 <0.01 <0.01 0.02 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 0.013 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 <0.054 <0.054 <0.054 <0.054 <0.054 <0.054 <0.054 0.065 <0.054 

0* 0 1 3 3 3 5 5 5 7 

formulation: OD 100 
- 293 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2128/04 R 2004 0881/1 E-41720 Los Palacios Sevilla, Spain 

Melon Montijo 

1 05.02.2004 2 01.04.2004 3 01.06.2004  - 01.07.2004 

0.0720 0.0720 0.0720 0.0720 

1000 1000 1000 1000 

0.0072

0.00720.00720.0072

10.05.2004 17.05.2004 24.05.2004 31.05.2004 

BBCH 84 fruit 

fruit fruit fruit pulp peel fruit pulp peel fruit 

<0.01 <0.01 <0.01 <0.01 <0.01 0.01 <0.01 <0.01 0.01 0.01 

0.012 0.017 0.019 0.015 <0.012 0.022 <0.012 <0.012 0.015 0.019 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012<0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.059 0.061 0.057 <0.054 0.064 <0.054 <0.054 0.057 0.061 

0* 0 1 3 3 3 4 4 4 7 

formulation: OD 100 

RA-2128/04 R 2004 0883/8 F-31 340 VACQUIERS, France 

Melon Porphyre 

1 29.03.2004 2 29.04.2004 3 18.06.2004  - 30.06.2004 

0.0720 0.0720 0.0720 0.0720 

1000 1000 1000 1000 

0.0072

0.00720.00720.0072

28.05.2004 04.06.2004 11.06.2004 18.06.2004 

BBCH 82 fruit 

fruit fruit fruit pulp peel fruit pulp peel fruit 

<0.01 <0.01 <0.01 <0.01 <0.01 0.01 <0.01 <0.01 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 <0.054 <0.054 <0.054 <0.054 <0.054 <0.054 <0.054 <0.054 <0.054 

0* 0 1 3 3 3 5 5 5 7 

formulation: OD 100 

Field conditions – Southern EuropeRA-2129/04 R 2004 0842/0 I-70031 Andria (Bari), Italy 

Melon Exsalto 

1. 10.04.2004 2. 20.05.2004 3. 10.07.2004  - 31.07.2004 

0.0720 0.0720 0.0720 0.0720 

750 750 750 750 

0.0096

0.00960.00960.0096

24.06.2004 01.07.2004 08.07.2004 15.07.2004 

BBCH 88 fruit 

fruit fruit fruit pulp peel fruit fruit pulp peel 

0.02 0.05 0.05 0.04 <0.01 0.08 0.04 0.03 <0.01 0.10 

<0.012 <0.012 0.014 <0.012 <0.012 0.021 <0.012 <0.012 <0.012 0.025 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.064 0.094 0.096 0.084 <0.054 0.133 0.084 0.074 <0.054 0.157 

0* 0 1 3 3 3 5 7 7 7 

formulation: OD 100 
- 294 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2129/04 R 2004 0843/9 E-08850 Gava (Barcelona), Spain 

Melon Braco 

1. 05.05.2004 2. 10.06.2004 3. 30.07.2004  - 20.08.2004 

0.0720 0.0720 0.0720 0.0720 

700 700 700 700 

0.0103

0.01030.01030.0103

20.07.2004 26.07.2004 02.08.2004 09.08.2004 

BBCH 89 fruit 

fruit pulp peel fruit fruit pulp peel 

<0.01 <0.01 <0.01 0.02 <0.01 <0.01 <0.01 <0.01 

<0.012 <0.012 <0.012 0.026 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 <0.054 <0.054 0.078 <0.054 <0.054 <0.054 <0.054 

1 3 3 3 4 7 7 7 

formulation: OD 100 

RA-2129/04 R 2004 0844/7 E-46230 Alginet, Spain 

Melon Sancho 

1. 01.06.2004 2. 20.06.2004 3. 01.08.2004  - 30.08.2004 

0.0720 0.0720 0.0720 0.0720 

750 750 750 750 

0.0096

0.00960.00960.0096

20.07.2004 27.07.2004 03.08.2004 10.08.2004 

BBCH 89 fruit 

fruit fruit fruit pulp peel fruit fruit pulp peel 

0.02 0.03 0.02 0.02 <0.01 0.06 0.02 0.01 <0.01 0.03 

0.025 0.043 0.027 0.036 <0.012 0.073 0.026 0.021 <0.012 0.041 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.077 0.105 0.079 0.088 <0.054 0.165 0.078 0.063 <0.054 0.103 

0* 0 1 3 3 3 6 7 7 7 

formulation: OD 100 

RA-2129/04 R 2004 0845/5 GR-60100 Aronas, Greece 

Melon Supra 

1. 08.06.2004 2. 30.06.2004 3. 05.08.2004  - 15.10.2004 

0.0720 0.0720 0.0720 0.0720 

500 500 500 500 

0.0144

0.01440.01440.0144

27.07.2004 03.08.2004 10.08.2004 17.08.2004 

BBCH 89 fruit 

fruit fruit fruit pulp peel fruit fruit pulp peel 

<0.01 0.01 0.02 0.01 <0.01 0.01 <0.01 <0.01 <0.01 0.01 

<0.012 0.019 0.020 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.061 0.072 <0.054 <0.054 <0.054 <0.054 <0.054 <0.054 <0.054 

0 0 1 3 3 3 5 7 7 7 

formulation: OD 100 
- 295 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2042/05 R 2005 0230/3 GR-60100 AronasKaterini, Greece 

Melon Gallia 

1. 27.05.2005 2. 10.06.2005 3. 22.07.2005  - 03.08.2005 

0.0720 0.0720 0.0720 0.0720 

600 600 600 600 

0.0120

0.01200.01200.0120

01.07.2005 08.07.2005 15.07.2005 22.07.2005 

BBCH 86 fruit 

fruit pulp peel fruit pulp peel fruit pulp peel 

0.01 <0.01 <0.01 0.02 <0.01 <0.01 0.02 <0.01 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.049 0.037 0.033 0.032 0.023 0.022 0.028 0.031 0.022 0.019 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.091 0.079 0.075 0.084 0.065 0.064 0.080 0.073 0.064 0.061 

0 3 3 3 5 5 5 7 7 7 

formulation: OD 150 

RA-2042/05 R 2005 0231/1 E-08850 Gava (Barcelona), Spain 

Melon SANCHO 

1. 04.05.2005 2. 25.05.2005 3. 15.08.2005  - 20.09.2005 

0.0720 0.0720 0.0669 0.0720 

600 600 558 600 

0.0120

0.01200.01200.0120

05.08.2005 12.08.2005 19.08.2005 26.08.2005 

BBCH 89 fruit 

fruit pulp peel fruit pulp peel fruit pulp peel 

<0.01 <0.01 <0.01 0.03 <0.01 <0.01 0.02 <0.01 <0.01 0.02 

0.014 0.014 <0.012 0.041 <0.012 <0.012 0.029 <0.012 <0.012 0.015 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.056 0.056 <0.054 0.103 <0.054 <0.054 0.081 <0.054 <0.054 0.067 

0 3 3 3 5 5 5 7 7 7 

formulation: OD 150 

RA-2042/05 R 2005 0233/8 P-2580-102 Aldeia Gavinha, Portugal 

Melon Albino 

1. 15.05.2005 2. 01.06.2005 3. 20.07.2005  - 05.08.2005 

0.0720 0.0720 0.0720 0.0720 

800 800 800 800 

0.0090

0.00900.00900.0090

27.06.2005 04.07.2005 11.07.2005 18.07.2005 

BBCH 87 fruit 

fruit fruit pulp peel fruit pulp peel fruit pulp peel fruit pulp peel 

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 

<0.012 0.016 0.021 <0.012 0.041 0.017 <0.012 0.036 0.015 <0.012 0.031 0.012 <0.012 0.023 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.058 0.063 <0.054 0.083 0.059 <0.054 0.078 0.057 <0.054 0.073 <0.054 <0.054 0.065 

0* 0 1 1 1 3 3 3 4 4 4 7 7 7 

formulation: OD 150 
- 296 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering 

3. Harvest 

kg a.s./ 

ha 

water 

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2042/05 R 2005 0234/6 I-95040 Licodia Eubea (CT.), Italy 

Melon Helios 

1. 06.05.2005 2. 01.06.2005 3. 20.07.2005  - 20.08.2005 

0.0720 0.0720 0.0720 0.0720 

600 600 800 1000 

0.0120

0.01200.00900.0072

08.07.2005 15.07.2005 22.07.2005 29.07.2005 

BBCH 84 fruit 

fruit fruit fruit pulp peel fruit pulp peel fruit pulp peel 

<0.01 0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 

<0.012 <0.012 <0.012 <0.012 <0.012 0.031 <0.012 <0.012 0.016 <0.012 <0.012 0.015 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 <0.054 <0.054 <0.054 <0.054 0.073 <0.054 <0.054 0.058 <0.054 <0.054 0.057 

0* 0 1 3 3 3 5 5 5 7 7 7 

formulation: OD 150 

RA-2042/05 R 2005 0717/8 E-46230 Alginet, Spain 

Melon Sirio 

1. 12.05.2005 2. 10.06.2005 3. 01.07.2005  - 10.08.2005 

0.0720 0.0720 0.0720 0.0720 

800 800 800 800 

0.0090

0.00900.00900.0090

01.07.2005 11.07.2005 18.07.2005 25.07.2005 

BBCH 89 fruit 

fruit fruit fruit pulp peel fruit pulp peel fruit pulp peel 

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 

<0.012 0.013 <0.012 <0.012 <0.012 0.018 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.055 <0.054 <0.054 <0.054 0.060 <0.054 <0.054 <0.054 <0.054 <0.054 <0.054 

0* 0 1 3 3 3 4 4 4 7 7 7 

formulation: OD 150 1st spray interval 10 days, because of bad weather conditions 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) 
- 297 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I n: Summary of trial information – flowering brassica 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Field trials, northern Europe RA-2022/04 R 2004 0105/1 D-40764 Langenfeld Germany 

broccoli Marathon 

1. 27.04.2004 3. 15.07.2004 

0.0720 0.0720 0.0720 

300 300 300 

0.024 0.024 0.024 

15.06.2004 22.06.2004 29.06.2004 

BBCH 45 curd 

curd curd curd curd 

<0.01 0.08 0.07 0.01 0.01 

0.17 0.17 0.20 0.14 0.097 

0.21 0.22 0.28 0.20 0.12 

<0.012 <0.012 <0.012 <0.012 <0.012 

0.013 0.013 0.016 0.012 0.008 

0.415 0.495 0.578 0.374 0.247 

0* 0 3 7 13 

formulation: 100 OD; 

RA-2022/04 R 2004 0108/6 GB-NR29 5DS Rollesby United Kingdom 

broccoli Marathon 

1. 07.07.2004 2. 07.09.2004 - 30.09.2004 3. 21.09.2004 - 28.09.2004 

0.0774 0.0720 0.0720 

323 300 300 

0.024 0.024 0.024 

24.08.2004 31.08.2004 07.09.2004 

BBCH 41 curd 

curd curd curd curd curd 

0.01 0.24 0.09 <0.01 <0.01 <0.01 

0.29 0.48 0.28 0.29 0.18 0.15 

0.067 0.14 0.13 0.13 0.10 0.048 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.009 0.008 0.009 0.008 0.008 0.008 

0.388 0.880 0.521 0.450 0.310 0.228 

0* 0 3 7 14 21 

formulation: 100 OD 

RA-2023/04 R 2004 109/4 D-40764 Langenfeld Germany 

cauliflower Freedom 

1. 27.04.2004 2. no data 3.15.07.2004 

0.0720 0.0720 0.0720 

300 300 300 

0.024 0.024 0.024 

15.06.2004 22.06.2004 29.06.2004 

BBCH 42 - 43 

curd curd curd curd curd 

<0.01 0.02 <0.01 <0.01 <0.01 

0.074 0.033 0.055 0.019 0.013 

0.20 0.24 0.34 0.28 0.14 

<0.012 <0.012<0.012 <0.012 <0.012 

0.008 0.011 0.010 0.010 0.008 

0.304 0.316 0.427 0.331 0.183 

0* 0 3 7 13 

formulation: 100 OD 

RA-2023/04 R 2004 0110/8 F-27340 Criquebeuf sur Seine N-France 

cauliflower AVISO 

1. 15.06.2004 2. no data 3. 19.10.2004 

0.0720 0.0720 0.0720 

300 300 300 

0.024 0.024 0.024 

21.09.2004 28.09.2004 05.10.2004 

BBCH 48 curd 

curd curd curd curd curd 

<0.01 0.01 0.02 <0.01 <0.01 <0.01 

0.035 0.079 0.077 0.14 0.15 0.12 

0.034 0.048 0.046 0.069 0.061 0.076 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.008 0.008 

0.099 0.157 0.163 0.239 0.241 0.226 

0* 0 3 7 14 21 

formulation: 100 OD 

RA-2062/05 R 2005 0363/6 D-42799 Leichlingen Germany 

broccoli Volta F1 

1. 01.06.2005 3. 25.06.2005 - 30.07.2005 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

30.06.2005 14.07.2005 28.07.2005 

BBCH 45 curd 

curd curd curd curd curd curd curd 

0.57 0.19 0.01 0.10 0.01 <0.01 <0.01 <0.01 

0.25 0.24 0.073 0.26 0.14 0.18 0.89 0.092 

0.10 0.18 0.074 0.17 0.13 0.15 0.047 0.038 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <o.012 <0.012 

<0.008 0.019 0.011 0.008 0.021 0.032 0.011 0.011 

0.940 0.641 0.180 0.550 0.313 0.384 0.169 0.163 

-14 -11 0* 0 3 7 14 21 

formulation: 150 OD 
- 298 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2062/05 R 2005 0364/4 F-80200 Ennemain N-France 

broccoli Lord 

1. 18.05.2005 2. 25.07.2005 - 10.08.2005 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

01.07.2005 15.07.2005 29.07.2005 

BBCH 48 curd 

curd curd curd curd curd 

0.09 0.03 0.11 0.01 0.01 0.01 

0.28 0.12 0.078 0.048 0.046 0.033 

0.12 0.082 0.047 0.032 0.025 0.022 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 0.018 0.008 <0.008 <0.008 0.008 

0.510 0.262 0.255 0.110 0.101 0.085 

-14 -11 0 3 7 14 

formulation: 150 OD 

RA-2062/05 R 2005 0365/2 D-67125 Schauernheim Germany 

cauliflower Cegano 

1. 25.07.2005 3. 13.10.2005 - 10.11.2005 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

14.09.2005 28.09.2005 12.10.2005 

BBCH 49 curd 

curd curd curd curd curd curd curd 

0.01 <0.01 <0.01 0.02 0.02 0.02 0.01 <0.01 

0.11 0.15 0.091 0.13 0.14 0.13 0.12 0.086 

0.027 0.029 0.023 0.048 0.040 0.031 0.034 0.030 

<0.012 <0.012<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 0.008 0.008 <0.008 0.008 0.008 

0.167 0.209 0.144 0.218 0.220 0.201 0.184 0.146 

-14 -11 0* 0 3 7 14 21 

formulation: 150 OD 

RA-2062/05 R 2005 1017/9 D-88074 Mecklenbeuren Germany 

broccoli Iron Man 

1. 22.07.2005 3. 01.10.2005 - 31.10.2005 

0.072 0.072 

600 600 

0.012 0.012 

13.09.2005 27.09.2005 

BBCH 46 curd 

curd 

0.07 0.01 

0.15 0.18 

0.099 0.098 

<0.012 <0.012 

0.008 0.008 

0.339 0.308 

0 3 

formulation: 150 OD 

RA-2062/05 R 2005 1047/0 GB-IP10 ORA Ipswich United Kingdom 

cauliflower Alpen 

1. 30.07.2005 3. 01.03.2006 - 21.03.2006 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

18.01.2006 01.02.2006 22.02.2006 

BBCH 45 curd 

curd curd curd curd curd 

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 

0.079 0.12 0.23 0.24 0.31 0.25 

0.012 0.012 0.036 0.059 0.029 0.039 

<0.012 0.012 <0.012 <0.012 <0.012 0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.121 0.162 0.296 0.329 0.369 0.319 

-21 -19 0 3 7 13 

formulation: 150 OD 

Field trials, Southern Europe RA-2024/04 R 2004 0111/6 I-71030 Zapponeta Italy 

broccoli Marathon 

1. 05.08.2004 3. 20.11.2004 - 30.12.2004 

0.0720 0.0720 0.0720 

800 800 800 

0.009 0.009 0.009 

12.11.2004 19.11.2004 26.11.2004 

BBCH 47 curd 

curd curd curd curd 

0.04 0.13 0.02 0.02 0.01 

0.13 0.19 0.20 0.31 0.25 

0.069 0.094 0.080 0.089 0.068 

<0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 0.008 <0.008 0.008 0.008 

0.259 0.434 0.320 0.439 0.348 

0* 0 3 7 14 

formulation:100 OD 
- 299 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2025/04 R 2004 0112/4 F-31150 Fenouillet S-France 

cauliflower Flamenco 

1. 02.08.2004 2. no data 3. 30.10.2004 - 30.11.2004 

0.0720 0.0720 0.0720 

500 500 500 

0.014 0.014 0.014 

26.10.2004 02.11.2004 09.11.2004 

BBCH 49 curd 

curd curd curd curd curd 

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 

0.075 0.095 0.077 0.13 0.13 0.11 

0.067 0.078 0.081 0.10 0.074 0.067 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.008 0.008 

0.172 0.203 0.188 0.260 0.234 0.207 

0* 0 3 7 14 20 

formulation:100 OD 

RA-2063/05 R 2005 0360/1 I-71043 Manfredonia Italy 

broccoli Marathon 

1. 10.08.2005 3. 10.11.2005 - 10.12.2005 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

19.10.2005 02.11.2005 16.11.2005 

BBCH 45 curd 

curd curd curd curd curd curd curd 

0.08 0.06 0.01 0.11 0.01 0.01 0.01 <0.01 

0.11 0.099 0.11 0.15 0.11 0.12 0.13 0.087 

0.037 0.036 0.025 0.043 0.029 0.035 0.036 0.026 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 0.008 0.008 0.008 0.008 0.008 0.008 0.011 

0.247 0.215 0.165 0.323 0.169 0.185 0.196 0.146 

-14 -11 0* 0 3 8 14 20 

formulation: 150 OD 

RA-2063/05 R 2005 0362/8 E-08850 Gava Spain 

cauliflower Flora Blanca 

1. 04.02.2006 3. 10.05.2006 - 20.05.2006 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

11.04.2006 25.04.2006 09.05.2006 

BBCH 43 whole pl. 

whole pl. curd curd curd curd 

1.0 0.06 0.01 0.13 0.01 <0.01 

0.23 0.10 0.039 0.085 0.070 0.084 

0.049 0.019 0.012 0.013 0.013 0.014 

<0.012 0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.013 0.008 0.010 

1.299 0.199 0.081 0.253 0.113 0.130 

-14 -11 0* 0 3 7 

formulation: 150 OD 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) whole pl. whole plant without roots 
- 300 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I o: Summary of trial information – Brussels sprouts 

Application rate 

per treatment 

Residues** 

[mg/kg]* 

Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohydrox

y 

BYI 

08330 

monohydrox

y 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Field trials, northern Europe RA-2039/04 R 2004 0160/4 D-53773 Hennef Germany 

brussels sprouts Igor F1 

1. 06.05.2004 3. 01.10.2004 - 31.12.2004 

0.0720 0.0720 0.0720 

500 500 500 

0.014 0.014 0.014 

30.09.2004 07.10.2004 14.10.2004 

BBCH 48 sprout 

sprout sprout sprout sprout 

0.01 0.03 0.01 0.01 0.01 

0.022 0.044 0.041 0.051 0.053 

0.012 0.016 0.013 0.025 0.014 

<0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.08 

0.064 0.11 0.084 0.106 0.097 

0* 0 3 7 14 

formulation: 100 OD 

RA-2039/04 R 2004 0161/2 D-40764 Langenfeld, Germany 

brussels sprouts Genius 

1. 27.04.2004 3. 15.10.2004 - 15.11.2004 

0.0720 0.0720 0.0720 

500 500 500 

0.014 0.014 0.014 

17.09.2004 24.09.2004 01.10.2004 

BBCH 47 sprout 

sprout sprout sprout sprout 

<0.01 0.01 0.01 0.01 0.01 

0.012 0.018 0.021 0.035 0.041 

0.012 0.013 0.012 0.018 0.017 

<0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.061 0.063 0.083 0.088 

0* 0 3 7 14 

formulation: 100 OD 

RA-2039/04 R 2004 0162/0 F-27340 Criqubeuf sur Seine N- France 

brussels sprouts Romulus 

1. 16.06.2004 3. 15.11.2004 

0.0720 0.0720 0.0720 

500 500 500 

0.014 0.014 0.014 

12.10.2004 22.10.2004 25.10.2004 

BBCH 46 sprout 

sprout sprout sprout sprout sprout 

0.01 0.02 0.01 <0.01 <0.01 <0.01 

0.023 0.043 0.039 0.069 0.051 0.051 

0.023 0.034 0.025 0.032 0.023 0.016 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.076 0.117 0.094 0.131 0.104 0.097 

0* 0 3 8 14 21 

formulation: 100 OD 

RA-2039/04 R 2004 0163/9 F-62390 Fontaine L’Etalon N-France 

brussels sprouts Maximum 

1. 05.05.2004 3. 01.09.2004 - 31.10.2004 

0.0720 0.0720 0.0720 

500 500 500 

0.014 0.014 0.014 

09.09.2004 16.09.2004 24.09.2004 

BBCH 48 sprout 

sprout sprout sprout sprout sprout 

<0.01 0.01 0.01 0.01 <0.01 <0.01 

0.042 0.051 0.075 0.099 0.098 0.13 

0.014 0.023 0.032 0.045 0.043 0.058 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.086 0.104 0.137 0.174 0.171 0.218 

0* 0 3 7 14 21 

formulation: 100 OD 

RA-2066/05 R 2005 0369/5 D-59457 WerlWestönnen Germany 

brussels sprouts Cyrus 

1. 25.05.2005 3. 15.09.2005  - 15.12.2005 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

30.08.2005 13.09.2005 27.09.2005 

BBCH 47 sprout 

sprout sprout sprout sprout sprout 

0.01 0.01 0.02 0.01 <0.01 <0.01 

0.032 0.036 0.049 0.029 0.026 0.024 

0.029 0.038 0.039 0.030 0.021 0.019 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.009 0.011 0.008 0.008 0.008 

0.091 0.105 0.131 0.089 0.077 0.073 

-14 -11 0 3 8 14 

formulation: 150 OD 
- 301 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* 

Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohydrox

y 

BYI 

08330 

monohydrox

y 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2066/05 R 2005 0370/9 F-27340 Criquebeuf sur Seine N-France 

brussels sprouts Abacus 

1. 15.06.2005 3. 24.10.2005 - 30.11.2005 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

26.09.2005 10.10.2005 24.10.2005 

BBCH 46 sprout 

sprout sprout sprout sprout sprout 

0.01 0.01 0.01 0.01 <0.01 0.01 

0.043 0.041 0.045 0.035 0.041 0.041 

0.027 0.023 0.020 0.020 0.017 0.018 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 0.008 0.008 0.008 0.008 

0.100 0.094 0.095 0.085 0.088 0.089 

-14 -11 0 3 7 14 

formulation: 150 OD 

RA-2066/05 R 2005 0371/7 D-53332 Bornheim Germany 

brussels sprouts Abacus 

1. 24.05.2005 3. 01.10 2005 - 15.12.2005 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

22.09.2005 06.10.2005 20.10.2005 

BCH 49 sprout 

sprout sprout sprout sprout sprout sprout sprout

0.01 0.01 0.02 <0.01 0.01 0.01 0.01 0.01 

0.030 0.033 0.071 0.057 0.057 0.064 0.064 0.060 

0.020 0.025 0.046 0.023 0.046 0.034 0.039 0.027 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 0.012 0.008 0.008 0.008 <0.008 0.008 0.030 

0.080 0.092 0.157 0.110 0.133 0.128 0.133 0.139 

-14 -11 0* 0 3 7 14 21 

formulation: 150 OD 

RA-2066/05 R 2005 0372/5 GB-IP17 3BS Saxmundham United Kingdom 

brussels sprouts Helemus 

1. 27.05.2005 3. 15.12.2005 - 31.01.2006 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

18.11.2005 01.12.2005 16.12.2005 

BBCH 49 sprout 

sprout sprout sprout sprout sprout sprout sprout 

0.02 0.01 0.02 <0.01 0.01 0.01 0.01 <0.01 

0.032 0.033 0.059 0.044 0.053 0.068 0.062 0.065 

0.012 0.012 0.012 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.008 <0.008 0.008 <0.008 <0.008 <0.008 <0.008 

0.084 0.075 0.111 0.086 0.095 0.110 0.104 0.107 

-15 -11 0* 0 3 7 14 21 

formulation: 150 OD 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) 
- 302 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I p: Summary of trial information – round cabbage, red cabbage and savoy cabbage 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Field trials, Northern Europe RA-2037/04 R 2004 0152/3 D-40764 Langenfeld, Germany 

round cabbage Attraktion 

1. 30.06.2004 3. 15.10.2004 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

20.09.2004 27.09.2004 04.10.2004 

BBCH 47 head 

head head head head 

0.01 0.13 0.01 0.01 <0.01 

0.024 0.025 0.032 0.037 0.018 

0.024 0.022 0.023 0.030 0.025 

<0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 

0.078 0.197 0.085 0.097 0.073 

0* 0 3 7 14 

formulation: 100 OD 

RA-2037/04 R 2004 0156/6 GB-PE22 7HG Frithville, United Kingdom 

red cabbage Rococo 

1. 18.05.2004 3. 15.09.2004 - 31.10.2004 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

06.09.2004 13.09.2004 21.09.2004 

BBCH 47 head 

head head head head head 

0.01 0.04 0.01 0.01 <0.01 <0.01 

0.065 0.062 0.060 0.059 0.062 0.059 

0.013 0.012 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.108 0.134 0.102 0.101 0.104 0.101 

0* 0 3 6 14 20 

formulation: 100 OD 

RA-2037/04 R 2004 0157/4 F-80500 Faverolles N-France 

Savoy cabbage Firenza 

1. 10.05.2004 3. 01.11.2004 - 15.12.2004 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

26.10.2004 03.11.2004 09.11.2004 

BBCH 49 head 

head head head head head 

<0.01 0.04 0.01 <0.01 <0.01 <0.01 

0.012 0.045 0.017 0.012 0.012 0.012 

0.035 0.070 0.044 0.014 0.012 0.013 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 

<0.008 0.008 0.008 <0.008 <0.008 <0.008 

0.077 0.175 0.091 0.056 <0.054 0.055 

0* 0 3 7 14 21 

formulation: 100 OD 

RA-2060/05 R 2005 0352/0 F-80480 Dury N-France 

red cabbage Rondon F1 

1. 15.06.2005 3. 01.10.2005 - 10.10.2005 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

24.08.2005 07.09.2005 21.09.2005 

BBCH 48 head 

head head head head head head head 

<0.01 0.012 <0.01 0.022 0.010 <0.01 <0.01 <0.01 

0.014 0.019 0.014 0.020 0.025 0.025 0.017 0.024 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.056 0.063 0.056 0.074 0.067 0.067 0.059 0.066 

-14 -11 0* 0 3 7 14 21 

formulation: 150 OD 

RA-2060/05 R 2005 0353/9 D-51399 Burscheid Germany 

red cabbage Roxy 

1. 10.05.2005 3. 15.09.2005 - 15.11.2005 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

30.08.2005 13.09.2005 27.09.2005 

BBCH 47 head 

head head head head head 

0.036 <0.01 0.038 <0.01 <0.01 <0.01 

0.01 0.095 0.11 0.092 0.090 0.072 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.078 0.137 0.180 0.134 0.132 0.114 

-14 -11 0 3 7 14 

formulation: 150 OD 
- 303 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2060/05 R 2005 0354/7 D-42799 Leichlingen Germany 

round cabbage Gilson F1 

1. 08.06.2005 3. 05.09.2005 - 25.09.2005 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

01.08.2005 15.08.205 29.08.2005 

BBCH 45 head 

head head head head head head head 

<0.01 <0.01 <0.01 0.057 0.011 <0.01 <0.01 <0.01 

0.032 0.052 0.040 0.058 0.061 0.062 0.053 0.037 

0.044 0.067 0.071 0.087 0.094 0.093 0.099 0.074 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.106 0.149 0.141 0.222 0.186 0.185 0.182 0.141 

-14 -11 0* 0 3 7 14 21 

formulation: 150 OD 

RA-2060/05 R 2005 0355/5 D-59457 WerlWestönnen Germany 

round cabbage Kingston 

1. 15.05.2005 3. 15.09.2005 - 30.10.2005 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

30.08.2005 13.09.2005 27.09.2005 

BBCH 48 head 

head head head head head 

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 

0.036 0.035 0.037 0.024 0.032 0.026 

0.021 0.022 0.021 0.014 0.015 0.013 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.087 0.087 0.088 0.068 0.077 0.069 

-14 -11 0 3 8 14 

formulation: 150 OD 

RA-2060/05 R 2005 0356/3 D-42799 Leichlingen Germany 

Savoy cabbage Rigoletto F1 

1. 08.06.2005 3. 05.09.2005 - 25.09.2005 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

01.08.2005 15.08.2005 29.08.2005 

BBCH 45 head 

head head head head head head head 

0.22 0.091 <0.01 0.11 0.031 <0.01 <0.01 <0.01 

0.11 0.12 0.076 0.093 0.11 0.064 0.081 0.055 

0.084 0.11 0.066 0.11 0.10 0.084 0.074 0.068 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.434 0.341 0.172 0.333 0.261 0.178 0.185 0.153 

-14 -11 0* 0 3 7 14 21 

formulation: 150 OD 

RA-2060/05 R 2005 0357/1 F-80200 Ennemain N-France 

savoy cabbage Ice Prince 

1. 18.05.2005 3. 22.10.2005 - 03.11.2005 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

19.09.2005 03.10.2005 17.10.2005 

BBCH 48 head 

head head head head head 

<0.01 0.013 0.013 <0.01 <0.01 <0.01 

<0.012 0.015 0.024 0.031 0.026 0.027 

<0.012 <0.012 0.028 0.031 0.021 0.018 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

<0.054 0.060 0.085 0.092 0.077 0.075 

-14 -11 0 3 7 14 

formulation: 150 OD 

RA-2060/05 R 2005 0359/8  D-51399 Burscheid Germany 

savoy cabbage Firensa 

1. 10.05.2005 3. 15.09.2005 - 15.11.2005 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

16.08.2005 30.08.2005 13.09.2005 

BBCH 45 head 

head head head head head 

0.38 0.24 0.30 <0.01 <0.01 <0.01 

0.13 0.12 0.10 0.060 0.06 0.042 

0.13 0.098 0.081 0.045 0.061 0.054 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.660 0.478 0.501 0.135 0.151 0.126 

-14 -11 0 3 7 14 

formulation: 150 OD 
- 304 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Field trials, Southern Europe RA-2038/04 R 2004 0158/2 E-08850 Gavá (Catalua) Spain 

red cabbage Sombrero 

1. 20.11.2004 3. 25.04.2005 - 20.05.2005 

0.072 0.072 0.072 

600 600 600 

0.012 0.012 0.012 

11.04.2005 18.04.2005 25.04.2005 

BBCH 45 head 

head head head head head 

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 

0.098 0.11 0.15 0.19 0.17 0.14 

0.012 0.012 0.012 0.012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 

<0.008 <0.008 <0.008 <0.008 0.008 0.008 

0.140 0.152 0.192 0.232 0.212 0.182 

0* 0 3 7 14 23 

formulation: 100 OD 

RA-2038/04 R 2004 159/0 I-70031 Andria (BA) (Puglia) Italy 

round cabbage Head Start F1 

1. 15.09.2004 3. 25.11.2004 - 25.12.2005 

0.072 0.072 0.072 

800 800 800 

0.009 0.009 0.009 

11.11.2004 18.11.2004 25.11.2004 

BBCH 47 head 

head head head head 

0.01 0.07 0.01 <0.01 <0.01 

0.024 0.039 0.036 0.051 0.065 

0.012 0.021 0.012 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 

0.066 0.150 0.078 0.093 0.107 

0* 0 3 7 14 

formulation: 100 OD 

RA-2061/05 R 2005 0350/4 I-70031 Andria Italy 

red cabbage Zelox 

1. 20.08.2005 3. 20.12.2005 - 20.01.2006 

0.072 0.072 0.072 

800 800 800 

0.009 0.009 0.009 

24.11.2005 08.12.2005 22.12.2005 

BBCH 46 head 

head head head head head head head 

0.041 <0.01 <0.01 0.030 <0.01 <0.01 <0.01 <0.01 

0.036 0.025 0.031 0.047 0.046 0.058 0.062 0.071 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 <0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0,012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.109 0.067 0.073 0.109 0.088 0.100 0.104 0.113 

-14 -11 0* 0 3 7 14 21 

formulation: 150 OD 

RA-2061/05 R 2005 0351/2 E-08840 Gava Spain 

round cabbage Gonzales Blanca 

1. 01.09.2005 3. 28.11.2005 - 28.12.2005 

0.072 0.072 0.072 

500 600 600 

0.014 0.012 0.012 

28.10.2005 19.11.2005 05.12.2005 

BBCH 45 head 

head head head head head 

0.010 <0.01 <0.01 <0.01 <0.01 <0.01 

0.019 0.022 0.032 0.029 0.032 0.034 

0.020 0.018 0.017 0.017 0.014 0.018 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.069 0.070 0.079 0.076 0.076 0.082 

-16 -13 0 2 7 14 

formulation: 150 OD 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) 
- 305 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I q: Summary of trial information – leafy brassica 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Field trials, Northern Europe RA-2040/04 R 2004 0164/7 GB-CB2 5EU Cambridge United Kingdom 

curly Kale Dwarf Greeen Curled 

1. 21.06.2004 3. no data 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

26.10.2004 01.11.2004 07.11.2004 

BBCH 49 leaf, n. 

leaf, n. leaf, n. leaf, n. leaf, n. 

0.40 1.2 0.15 0.20 0.07 

0.33 0.42 0.22 0.29 0.28 

0.12 0.24 0.081 0.11 0.080 

<0.012 <0.012 <0.012 <0.012<0.012 

0.008 0.008 0.008 0.008 0.012 

0.870 1.880 0.471 0.620 0.454 

0* 0 3 8 15 

formulation:100 OD 

RA-2040/04 R 2004 0165/5 D-40789 Monheim Germany 

curly Kale Winterbor 

1. 16.06.2004 3. 15.09.2004 

0.072 0.072 0.072 

500 500 500 

0.014 0.014 0.014 

24.08.2004 31.08.2004 07.09.2004 

BBCH 47 leaf, n. 

leaf, n. leaf, n. leaf, n. leaf, n. leaf, n. 

0.08 1.0 0.50 0.07 0.05 0.03 

0.070 0.23 0.12 0.053 0.050 0.041 

0.094 0.18 0.12 0.064 0.048 0.037 

<0.012 <0.012 <0.012 <0.012<0.012 <0.012 

0.012 0.014 0.013 0.015 0.020 0.018 

0.268 1.436 0.765 0.214 0.180 0.138 

-1 0 3 7 14 20 

formulation:100 OD 

RA-2064/05 R 2005 0367/9 D-40789 Monheim Germany 

curly Kale Winterbor 

1. 25.05.2005 3.20.08.2005- 1.10.2005 

0.0720 0.0720 0.0720 

600 600 600 

0.012 0.012 0.012 

25.07.2005 08.08.2005 22.08.2005 

BBCH 48 leaf, n. 

leaf, n. leaf, n. leaf, n. leaf, n. leaf, n. leaf, n. leaf, n. 

1.2 0.90 0.0450.87 0.086 0.046 0.029 0.010 

0.15 0.079 0.059 0.21 0.092 0.061 0.062 0.038 

0.055 0.072 0.019 0.053 0.042 0.033 0.021 0.014 

<0.012 <0.012 <0.012 <0.012<0.012<0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 0.010 <0.008 

1.425 1.071 0.143 1.153 0.240 0.160 0.134 0.082 

-14 -11 0* 0 3 7 14 21 

formulation: 150 OD 

RA-2064/05 R 2005 0368/7 D-51399 Burscheid Germany 

curly Kale Winterbor 

1. 10.05.2005 3.15.09.2005 -15.11.2005 

0.0720 0.0720 0.0720 

500 500 500 

0.014 0.014 0.014 

16.08.2005 30.08.2005 13.09.2005 

BBCH 78 leaf, n. 

leaf, n. leaf, n. leaf, n. leaf, n. leaf, n. 

1.1 0.91 1.1 0.029 0.020 0.019 

0.18 0.18 0.28 0.16 0.21 0.12 

0.051 0.072 0.075 0.035 0.051 0.022 

<0.012 <0.012 <0.012 <0.012<0.012<0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

1.351 1.182 1.475 0.244 0.301 0.181 

-14 -11 0 3 7 14 

formulation:150 OD 

Field trials, Southern Europe RA-2041/04 R 2004 0166/3 F-86380 Ouzilly France 

chinese kale Optiko 

1. 08.07.2004 3. 15.09.2004 - 30.09.2004 

0.0720 0.0720 0.0720 

600 600 600 

0.012 0.012 0.012 

23.08.2004 30.08.2004 06.09.2004 

BBCH 43 leaf, n. 

leaf, n. leaf, n. leaf, n. 

0.38 0.11 0.01 <0.01 

0.37 0.28 0.19 0.15 

0.11 0.12 0.056 0.046 

<0.012 <0.012 <0.012 <0.012 

0.029 0.034 0.037 0.039 

0.901 0.556 0.305 0.257 

0 3 7 14 

formulation: 100 OD 
- 306 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA -2041/04 R 2004 0167/1 E-08850 Gava Spain 

chinese kale Onekilo 

1. 07.08.2004 3. 01.10.2004 - 20.10.2004 

0.0720 0.0760 0.0720 

600 633 600 

0.012 0.012 0,012 

17.09.2004 23.09.2004 01.10.2004 

BBCH 47 leaf, n. 

leaf, n. leaf, n. leaf, n. leaf, n. leaf, n. 

0.10 0.47 0.08 0.07 <0.01 <0.01 

0.28 0.50 0.38 0.31 0.38 0.25 

0.099 0.18 0.12 0.11 0.16 0.11 

<0.012 <0.012 <0.012 <0.012<0.012 <0.012 

0.043 0.054 0.039 0.043 0.028 0.030 

0.534 1.216 0.631 0.545 0.590 0.412 

0* 0 4 7 14 20 

formulation: 100 OD 

RA-2136/05 R 2005 0709/7 E-08840 Gava Spain 

chinese cabbage One Kilo 

1. 01.09.2005 3. 20.10.2005 - 15.11.2005 

0.0660 0.0720 0.0720 

552 1000 1500 

0.012 0.007 0.005 

21.09.2005 05.10.2005 19.10.2005 

BBCH 46 head 

head head head head head head 

0.94 0.28 <0.01 <0.01 <0.01 <0.01<0.01 

0.72 0.49 0.12 0.19 0.16 0.082 0.060 

0.13 0.15 0.047 0.069 0.12 0.068 0.055 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

1.810 0.940 0.197 0.289 0.310 0.180 0.145 

-14 -12 0 2 7 14 21 

formulation:150 OD 

RA-2136/05 R 2005 0710/0 I-70031 Andria Italy 

chinese cabbage Taranko 

1. 12.08.2005 3. 01.10.2005 - 30.11.2005 

0.0720 0.0720 0.0720 

1000 1000 1000 

0.007 0.007 0.007 

14.09.2005 28.09.2005 12.10.2005 

BBCH 48 head 

head head head head head head head 

0.048 <0.01 <0.01 0.020 <0.01 <0.01 <0.01 <0.01 

0.11 0.16 0.11 0.11 0.13 0.15 0.13 0.13 

0.033 0.028 0.021 0.029 0.026 0.032 0.026 0.035 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 

0.211 0.218 0.161 0.179 0.186 0.212 0.186 0.195 

-14 -11 0* 0 3 7 14 21 

formulation: 150 OD 

leaf, n. = leaf, normal * Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) 
- 307 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I r: Summary of trial information – kohlrabi 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Field trials, Northern Europe RA-2043/04 R 2004 0169/8 D-59457 WerlWestönnen Germany 

kohlrabi Koist 

1. 27.04.2004 3. 05.06.2004 - 15.6.2004 

0.0720 0.0720 0.0720 

400 400 400 

0.018 0.018 0.018 

06.05.2004 14.05.2004 21.05.2004 

2nd appl.: BBCH 17 3rd appl.: BBCH 19 

corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. 

0.01 0.04 0.03 1.2 0.01 0.66 0.01 0.06 <0.01 <0.01 <0.01 <0.01 

0.42 0.41 0.55 2.1 0.52 1.2 0.51 0.73 0.33 0.10 0.13 0.023 

0.064 0.11 0.11 0.48 0.12 0.29 0.083 0.14 0.020 0.032 0.012 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 0.021 0.008 0.023 0.008 0.027 <0.008 0.028 <0.008 0.017 <0.008 0.014 

0.514 0.593 0.710 3.815 0.670 2.189 0.623 0.970 0.380 0.171 0.172 0.071 

0* 0* 

0 0 3 3 7 7 

14 14 21 21 

formulation:100 OD 

RA-2043/04 R 2004 0170/1 NL-1681 ND ZwaagdijkOost Netherlands 

kohlrabi Olivia 

1. 08.06.2004 3. 25.07.2004 - 25.08.2004 

0.0720 0.0720 0.0720 

600 600 600 

0.012 0.012 0.012 

13.07.2004 21.07.2004 28.07.2004 

2nd appl.: BBCH 41 3rd appl.: BBCH 43 

corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. 

<0.01 0.08 0.01 1.5 0.01 0.91 <0.01 0.49 <0.01 0.05 <0.01 0.01 

0.37 0.10 0.42 0.62 0.42 0.35 0.49 0.16 0.28 0.041 0.20 0.041 

0.032 0.038 0.038 0.21 0.033 0.097 0.034 0.059 0.018 0.012 0.012 0.012 

<0.012 <0.012 <0.012<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012<0.012 

<0.008 0.033 <0.008 0.042 <0.008 0.042 0.008 0.056 0.008 0.067 <0.008 0.061 

0.432 0.263 0.488 2.384 0.483 1.411 0.554 0.777 0.328 0.182 0.242 0.136 

0* 0* 

0 0 3 3 7 7 

14 14 21 21 

formulation:100 OD 
- 308 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2065/05 R 2005 0373/3 D-40764 LangenfeldReusrath Germany 

kohlrabi Lech 

1. 25.04.2005 3.17.06.2005- 01.07.2005 

0.0720 0.0720 0.0720 

600 600 600 

0.012 0.012 0.012 

19.05.2005 03.06.2005 17.06.2005 

2nd appl.: 

BBCH 43 3rd appl.: BBCH 46 

corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. 

0.01 0.57 0.01 0.12 0.01 1.1 0.01 1.3 0.01 0.08 0.01 0.10 <0.01 0.02 <0.01 0.01 

0.096 0.87 0.22 0.18 0.15 0.42 0.13 0.41 0.19 0.14 0.15 0.032 0.094 0.012 0.045 0.012 

0.013 0.28 0.017 0.062 0.013 0.11 0.013 0.12 0.012 0.044 0.012 <0.012 0.012 <0.012 0.012 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

<0.008 0.022 <0.008 0.025 <0.008 0.022 <0.008 0.022 <0.008 0.038 <0.008 0.040 <0.008 0.032 <0.008 0.029 

0.139 1.754 0.267 0.399 0.193 1.664 0.173 1.864 0.232

0.314 0.192 0.196 0.136 0.088 0.087 0.075 

-14 -14 -11 -11 

0* 0* 

0 0 3 3 7 7 

14 14 21 21 

formulation: 150 OD 

RA-02065/05 R 2005 0374/1 D-51399 Burscheid Germany 

kohlrabi Avanti F1 

1. 10.05.2005 3. 20.07.2005 - 30.08.2005 

0.0720 0.0720 0.0720 

1000 1000 1000 

0.007 0.007 0.007 

29.06.2005 13.07.2005 27.07.2005 

2nd appl.: 

BBCH 42 3rd appl.: BBCH 47 

corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n. corm leaf, n.corm leaf, n. corm leaf, n. 

0.03 1.3 0.01 0.38 0.02 0.77 0.01 0.03 <0.01 0.01 <0.01 0.01 <0.01 <0.01 

0.18 0.38 0.16 0.17 0.13 0.24 0.11 0.027 0.11 0.074 0.088 0.045 0.068 0.023 

0.015 0.044 0.014 0.025 0.012 0.034 0.012 0.012 0.012 0.014 0.012 0.012 0.012 0.012 

<0.012 <0.012 <0.012<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.008 0.038 0.008 0.044 0.008 0.054 <0.008 0.048 <0.008 0.062 <0.008 0.057 <0.008 0.052 

0.245 1.774 0.204 0.631 0.182 1.11 0.152 0.129 0.152

0.172 0.13 0.136 0.110 0.109 

-14 -14 -11 -11 

0* 0* 

0 0 3 3 7 7 

14 14 

formulation:150 OD 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) leaf, n. leaf, normal 
- 309 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I s: Summary of trial information – green beans 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Field trials, glasshouse RA-2042/04 R 2004 0172/8 I-00050 Palidoro Fiumicino Italy 

climbing French bean Emerite 

1. 02.04.2004 2. 21.05.2004 3. 04.06.2004 - 30.06.2004 

0.0864 0.1296 0.1440 0.1440 

600 900 1000 1000 

0.014 0.014 0.014 0.014 

14.05.2004 21.05.2004 28.05.2004 04.06.2004 

BBCH 71 bean w.p 

bean w.p bean w.p. bean w.p. bean w.p. bean w.p. 

0.03 0.24 0.13 0.06 0.06 0.04 

0.17 0.26 0.25 0.11 0.12 0.063 

0.19 0.22 0.20 0.12 0.081 0.042 

<0.012 0.012 0.012 0.012 0.012 0.012 

0.024 0.030 0.038 0.025 0.030 0.023 

0.426 0.762 0.630 0.327 0.303 0.180 

0* 0 7 10 14 21 

formulation: 100 OD 

RA-2042/04 R 2004 0173/6 I-71043 Manfredonia Italy 

climbing French bean Blue Lake 

1. 05.04.2004 2. 10.05.2004 3. 28.06.2004 - 15.09.2004 

0.1440 0.1440 0.14400.1440 

1000 1000 1000 1000 

0.014 0.014 0.014 0.014 

21.06.2004 28.06.2004 05.07.2004 12.07.2004 

BBCH 76 bean w.p 

bean w.p bean w.p. bean w.p. bean w.p. bean w.p. 

0.19 0.42 0.52 0.28 0.01 0.01 

0.25 0.46 0.34 0.25 0.066 0.036 

0.077 0.12 0.089 0.076 0.020 0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.021 0.025 0.035 0.029 0.008 0.008 

0.550 1.037 0.996 0.647 0.116 0.0780 

0* 0 7 10 14 21 

formulation: 100 OD 

RA-2042/04 R 2004 0174/4 D-40764 Langenfeld Germany 

climbing French bean Markant 

1. 30.04.2004 2. 01.06.2004 3. 15.07.2004 

0.1440 0.1440 0.1440 0.1440 

1000 1000 1000 1000 

0.014 0.014 0.014 0.014 

15.06.2004 22.06.2004 29.06.2004 06.07.2004 

BBCH 78 bean w.p 

bean w.p bean w.p. bean w.p. bean w.p. bean w.p. 

0.16 0.20 0.15 0.04 0.13 0.03 

0.23 0.22 0.27 0.23 0.29 0.19 

0.11 0.13 0.12 0.099 0.099 0.055 

<0.012 <0.012 0.012 0.012 0.012 0.012 

0.018 0.018 0.026 0.021 0.035 0.032 

0.530 0.580 0.578 0.402 0.566 0.319 

0* 0 7 10 14 21 

formulation: 100 OD 

RA-2042/04 R 2004 0175/2 F-13870 Rognonas S-France 

climbing French bean Helda 

1. 08.04.2004 2. 15.05.2004 3. 01.06.2004 - 30.06.2004 

0.1260 0.1260 0.1260 0.1260 

875 875 875 875 

0.014 0.014 0.014 0.014 

19.05.2004 26.05.2004 02.06.2004 09.06.2004 

BBCH 79 bean w.p 

bean w.p bean w.p. bean w.p. bean w.p. bean w.p. 

0.10 0.28 0.22 0.35 0.15 0.04

0.088 0.15 0.24 0.28 0.26 0.19

0.16 0.21 0.17 0.10 0.099 0.080 

0.012 0.012 0.012 0.012 0.012 0.012 

0.024 0.025 0.033 0.040 0.043 0.054 

0.384 0.677 0.675 0.782 0.564 0.376

0* 0 7 10 14 21 

formulation: 100 OD 

RA-2042/04 R 2004 0176/0 I-00052 FurbaraCerveteri Italy 

climbing French bean Emerite 

1. 09.04.2004 2. 21.05.2004 3. 03.06.2004 - 29.06.2004 

0.0864 0.1368 0.1440 0.1440 

600 950 10001000 

0.014 0.014 0.014 0.014 

17.05.2004 24.05.2004 31.05.2004 07.06.2004 

BBCH 71 bean w.p 

bean w.p bean w.p. bean w.p. bean w.p. bean w.p. 

0.01 0.04 0.01 0.01 0.01 <0.01 

0.041 0.054 0.049 0.031 0.015 <0.012 

0.10 0.10 0.11 0.070 0.037 <0.012 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.009 0.010 0.014 0.012 0.008 <0.008 

0.172 0.216 0.195 0.135 0.082 0.054

0* 0 7 10 14 21 

formulation: 100 OD 
- 310 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2042/04 R 2004 0177/9 I-70052 Molfetta Italy 

climbing French bean Blue Lakes 

1. 03.04.2004 2. 15.05.2004 3. 15.06.2004 - 20.07.2004 

0.1440 0.1440 0.1440 0.1440 

1000 1000 1000 1000 

0.014 0.014 0.014 0.014 

26.05.2004 02.06.2004 09.06.2004 16.06.2004 

BBCH 74 bean w.p 

bean w.p bean w.p. bean w.p. bean w.p. bean w.p. 

0.01 0.08 0.02 0.01 0.01 <0.01 

0.037 0.082 0.068 0.046 0.090 0.026 

0.084 0.20 0.14 0.075 0.084 0.023 

<0.012 <0.012 <0.012 <0.012 <0.012 <0.012 

0.009 0.009 0.012 0.009 0.012 0.008 

0.152 0.383 0.252 0.152 0.208 0.079

0* 0 7 10 14 21 

formulation: 100 OD 

RA-2042/04 R 2004 0178/7 F-13550 Noves S-France 

climbing French bean Donna 

1. 12.04.2004 2. 20.05.2004 3. 05.06.2004 - 30.06.2004 

0.1260 0.1260 0.1260 0.1260 

875 875 875 875 

0.014 0.014 0.014 0.014 

19.05.2004 26.05.2004 02.06.2004 09.06.2004 

BBCH 79 bean w.p 

bean w.p bean w.p. bean w.p. bean w.p. bean w.p. 

0.06 0.13 0.08 0.13 0.11 0.13 

0.10 0.13 0.22 0.26 0.27 0.29 

0.14 0.17 0.16 0.11 0.12 0.12 

0.012 0.012 0.012 0.012 0.012 0.017 

0.020 0.020 0.027 0.031 0.043 0.067 

0.332 0.462 0.499 0.543 0.555 0.624 

0* 0 7 10 14 21 

formulation: 100 OD 

RA-2042/04 R 2004 0179/5 D-40764 Langenfeld Germany 

climbing French bean Markant 

1. 30.06.2004 2. 01.08.2004 3. 01.09.2004 - 30.09.2004 

0.1440 0.1440 0.1440 0.1440 

1000 1000 1000 1000 

0.014 0.014 0.014 0.014 

11.08.2004 18.08.2004 25.08.2004 01.09.20o4 

BBCH 73 bean w.p 

bean w.p bean w.p. bean w.p. bean w.p. bean w.p. 

0.02 0.09 0.06 0.07 0.04 0.02 

0.23 0.26 0.40 0.36 0.23 0.15 

0.16 0.14 0.11 0.13 0.098 0.061 

0.012 <0.012 0.012 0.012 <0.012 <0.012 

0.012 0.012 0.023 0.022 0.021 0.015 

0.434 0.514 0.605 0.594 0.401 0.258

0* 0 7 10 14 21 

formulation: 100 OD 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) bean w.p. bean with pod 
- 311 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex I t: Summary of trial information – hop 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

Field trials, Northern Europe RA-2036/04 R 2004 0148/5 F-67160 Schleithal N-France 

hop Strisselspalt 

3. 31.08.2004 - 07.09.2004 

0.175 0.175 

2200 2400 

0.008 0.007 

27.04.2004 09.08.2004 

1st appl.: BBCH 65 2nd appl.: BBCH 75 

cone, g. cone, g. cone, g. cone, KD cone, g. cone, KD cone, g cone, KD 

0.40 0.58 0.11 0.24 0.17 0.63 0.10 0.52 

<0.12 0.18 <0.12 0.23 <0.12 0.18 <0.12 0.15 

<0.12 <0.12 <0.12 0.19 <0.12 0.30 <0.12 0.19 

<0.12 <0.12 <0.12 <0.12 <0.12 <0.12 <0.12 <0.12 

0.14 0.31 0.09 0.27 0.13 0.41 0.09 0.43 

0.9 1.31 0.56 1.05 0.66 1.64 0.55 1.41 

0* 0 8 8 14 14 22 22 

formulation: 100 OD 

RA-2036/04 R 2004 0149/3 D-85283 Gebrontshausen Germany 

hop Hallertauer Tradition 

1. 1993 2. 31.08.2004 3. 31.08.2004 

0.162 0.175 

2308 2500 

0.007 0.007 

27.07.2004 11.08.2004 

1st appl.: BBCH 68-89 2nd appl.: BBCH 72-75 

cone,g. cone, g. cone, g. cone, KD cone, g. cone, KD cone g. cone, KD 

0.21 1.5 0.25 1.7 0.27 0.56 0.26 0.94 

<0.12 0.67 0.21 0.97 <0.12 0.25 <0.12 0.35 

<0.12 0.27 0.23 1.0 0.17 0.39 0.15 0.51 

<0.12 <0.12 <0.12 <0.12 <0.12 <0.12 <0.12 <0.12 

0.14 0.19 0.25 1.0 0.21 0.50 0.23 0.70 

0.71 2.75 1.06 4.79 0.89 1.82 0.88 2.62 

0* 0 7 7 14 14 22 22 

formulation: 100 OD 

RA-2036/04 R 2004 0150/7 D-88069 Tettnang Germany 

hop Hallertauer Mittelfrüh 

1. 1966 2. 30.08.2004 3. 30.08.2004 

0.175 0.175 

2500 2500 

0.007 0.007 

28.07.2004 10.08.2004 

1st appl.: BBCH 71-75 2nd appl.: BBCH 75-77 

cone, g. cone g. cone, g. cone, KD cone, g. cone, KD cone g. cone, KD cone, g. 

0.14 0.98 0.43 2.0 0.19 1.1 0.25 1.2 0.26 

0.31 0.88 0.27 1.1 <0.12 0.75 0.14 0.58 0.20 

<0.12 0.24 0.34 1.4 0.14 0.75 0.16 0.60 0.17 

<0.12 <0.12 <0.12 <0.12 <0.12 <0.12 <0.12 <0.12 <0.12 

0.21 0.39 0.38 1.6 0.26 1.3 0.30 1.2 0.46 

0.9 2.61 1.54 6.22 0.83 4.02 0.97 3.7 1.21 

0* 0 7 7 14 14 21 21 28 

formulation: 100 OD 
- 312 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Application rate 

per treatment 

Residues** 

[mg/kg]* Report No. 

Trial No 

Location 

Commodity

/ 

Variety 

Date of 

1. Sowing or 

planting 

2. Flowering

3. Harvest 

kg a.s./ 

ha 

water

l/ha 

kg 

a.s./hl 

Dates of 

treatment(s) 

or no. of 

treatment 

and last date 

Growth 

stage at 

last 

treatment 

or date 

Portion 

analysed BYI 

08330 

BYI 

08330-

enol 

BYI 

08330 

ketohy

droxy 

BYI 

08330 

monoh

ydroxy 

BYI 

08330 

enol-Glc 

Total 

as BYI 

08330 

PHI 

[days] Remarks 

RA-2036/04 R 2004 0151/5 F-67210 Obernai N-France 

hop Strisselspalt 

1. 1998 2. 01.07.2004 - 25.07.2004 3. 14.09.2004 

0.175 0.175 

2200 2200 

0.008 0.008 

10.08.2004 23.08.2004 

1st appl.: BBCH 75 2nd appl.: BBCH 81 

cone, g. cone g. cone, g. cone, KD cone, g. cone, KD cone g. cone, KD cone, g. 

0.14 0.97 0.70 2.3 0.63 2.6 0.53 2.2 0.53 

<0.12 0.32 <0.12 0.28 <0.12 0.32 <0.12 0.25 <0.12 

<0.12 0.20 0.22 0.62 0.19 0.72 0.13 0.45 <0.12 

<0.12 <0.12 <0.12 <0.12 <0.12 <0.12 <0.12 <0.12 <0.12 

0.10 0.10 0.15 0.36 0.14 0.58 0.15 0.49 0.15 

0.6 1.71 1.31 3.68 1.2 4.34 1.05 3.51 1.04 

0* 0 8 8 15 15 22 22 29 

formulation: 100 OD 

RA -2108/05 R 2005 0550/7 D-85382 Gebrotshausen Germany 

hop Hallertauer Tradition 

1. 1995 2. 01.07.2005 3. 02.09.2005 

0.1500 2200 0.007 11.08.2005 BBCH 82 cone, g. 

cone, g. cone, g. cone, KD cone, g. cone, KD 

0.85 0.28 0.15 1.5 0.11 0.93 

0.24 0.12 <0.12 0.19 <0.12 0.21 

<0.12 <0.12 <0.12 <0.12 <0.12 <0.12 

<0.12 <0.12 <0.12 <0.12 <0.12 <0.12 

<0.08 0.08 0.08 0.08 0.08 0.08 

1.41 0.72 0.59 2.01 0.55 1.46 

0 7 14 14 21 21 

formulation: 150 OD 

RA-2108/05 R 2005 0551/5 F-67160 Schleithal N-France 

hop Strisselspalt 

1. 01.06.1998 3. 01.09.2005 

0.1500 2000 0.008 26.08.2005 BBCH 84 cone, g. 

cone, g. cone, g. cone, KD cone, g. cone, KD 

0.94 0.28 0.15 0.83 0.10 0.60 

0.30 0.12 0.12 0.23 0.12 0.14 

<0.12 <0.12 <0.12 0.43 <0.12 0.21 

<0.12 <0.12 <0.12 <0.12 <0.12 <0.12 

<0.08 0.08 0.08 0.13 0.08 0.13 

1.56 0.72 0.59 1.74 0.54 1.2 

0 7 13 13 20 20 

formulation: 150 OD 

RA-2108/05 R 2005 0552/3 D-88069 Tettnang Germany 

hop Hallertauer Mittelfrüh 

1. 1966 2. 10.07.2005 3. 31.08.2005 

0.1500 2200 0.007 11.08.2005 BBCH 

75-82 

cone, g. cone, g. cone, KD cone, g. cone, KD 

0.98 0.32 1.5 0.21 1.1 

0.36 0.12 0.32 0.12 0.31 

<0.12 0.17 0.88 0.12 0.52 

<0.12 <0.12 <0.12 <0.12 <0.12 

<0.08 0.08 0.29 0.08 0.33 

1.66 0.81 3.11 0.65 2.38 

0 14 14 21 21 

formulation: 150 OD 

RA-2108/05 R 2005 0553/1 F-67210 Obernai France 

hop Strisselspalt 

1. 1998 3.10.09.2005 - 20.09.2005 

0.1500 2000 0.008 30.08.2005 BBCH 86 cone, g. 

cone, g. cone, KD cone, g. cone, KD 

0.42 <0.1 0.61 <0.1 0.47 

0.12 <0.12 0.12 <0.12 0.12 

<0.12 <0.12 0.18 <0.12 0.13 

<0.12 <0.12 <0.12 <0.12 <0.12 

<0.08 <0.08 0.08 <0.08 0.08 

0.86 0.54 1.11 0.54 0.92 

0 14 14 21 21 

formulation: 150 OD 

* Before the last treatment ** Residues of each analyte calculated as spirotetramat (BYI 08330) cone, g. cone, green cone, KD cone, kiln-dried 
- 313 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex II – Summary of trials conducted in NAFTA Regions 

Residues were obtained using a modified version of the analytical method for determining the total 

spirotetramat residues (consisting of total residues of spirotetramat, BYI 08330-enol, BYI 08330-ketohydroxy, 

BYI 08330-mono-hydroxy and BYI 08330-enol-Glc) in crops (Method 00857). 

The extraction of plant commodities to determine the total spirotetramat residue involved blending a 5-g 

sample with acetonitrile (ACN)/H2O (4:1) containing 0.02% (v/v) formic acid. Celite® was added, and the 

slurry was filtered. The filter cake was washed with additional extraction solvent, and the volume of the 

extract was adjusted to 50 mL with the extraction solvent. An aliquot of a mixture of [13C] isotopically labelled 

internal standards was added to a 2-mL aliquot of the extract, and the sample was evaporated to near 

dryness. The sample was reconstituted with Millipore water, and the aliquot was analyzed using HPLCMS/MS. The method was successfully validated by analysis of RACs spiked at 0.01 ppm, for each analyte in 

all matrices. Therefore the LOQ for each analyte in all matrices was reported as 0.01 ppm. 

All residues were corrected to spirotetramat parent equivalents for reporting purposes. The residues of all 

five analytes (greater than the respective analyte limit of detection) were summed to obtain the total

spirotetramat residue for the sample. For the purpose of calculating the total spirotetramat residue,

individual analyte residues that were reported as <LOQ were assigned a finite value of the LOQ for that 

specific analyte. 

CROP FIELD TRIALS ON POTATO PMRA # 1314451 

GAP: Maximum seasonal rate of 175 g a.i./ha with a minimum interval of 7 days between applications and a PHI of 7 

days. 

Sixteen field trials were completed to investigate the magnitude of total BYI 08330 residues in potatoes treated with two 

foliar applications of BYI 08330 150 OD or 240 SC. An appropriate number of trials were conducted in the NAFTA 

representative growing regions. Each formulation was applied at a rate of 0.086-0.092 kg a.i./ha with a re-treatment 

interval of 5 to 7 days for a total seasonal application rate of 0.173-0.180 kg a.i./ha. All applications were made using 

spray volumes of 121 to 191 L/ha and Dyne-Amic (0.5% v/v) as an adjuvant. Potato tubers were harvested 7 days after 

the last application. Decline experiments were performed at two different sites in order to ascertain changes in the 

magnitude of residues with time. The total residues of spirotetramat declined when the PHI increased from 3 to 20 days, 

but it was only observed at one site. Total spirotetramat residues were higher with the 150 OD formulation in comparison 

to the 240 SC formulation. 

Total Spirotetramat Residue Levels (ppm) 

Commodity 

Total Rate 

(kg 

a.i./ha) 

PHI 

(days) n Min. Max. HAFT Median Mean SD 

Potato -150 OD 7 32 <0.050 0.457 0.450 0.119 0.171 0.125 

Potato -240 SC 

0.173-

0.180 7 8 <0.060 0.139 0.138 0.075 0.087 0.032 
- 314 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

CROP FIELD TRIALS ON BRASSICA LEAFY VEGETABLES PMRA #1314488 

GAP: Maximum seasonal rate of 175 g a.i./ha with a minimum interval of 7 days between applications and a PHI of 1 

day. 

A total of twenty field trials were conducted in representative commodities of crop subgroup 5A (broccoli (3), cauliflower 

(3), and cabbage (6) and subgroup 5B (mustard greens (8)). A decline trial was conducted with broccoli, cabbage and 

mustard greens. An appropriate number of trials were conducted in the NAFTA representative growing regions. BYI 

08330 100 OD or BYI 08330 240 SC were applied at target rates of 88 g a.i./ha/application at intervals of 5-7 days for a 

total seasonal application rate of 171-184 g a.i./ha (BYI 08330 100 OD) and 174-176 g a.i./ha (BYI 08330 240 SC). All 

applications were made using spray volumes of 102 to 188 L/ha and Dyne-Amic (0.5% v/v) as an adjuvant. Total residues 

of spirotetramat were generally higher in commodities treated with the 100OD formulation in comparison to the 240SC 

formulation.There was no clear decline of total BYI 08330 residues in broccoli/cauliflower treated with either the 100OD or 

240SC formulated products. Decline of total BYI 08330 residues was only observed in cabbage heads with wrapper 

leaves treated with the 100OD formulation. Total BYI 08330 residues in mustard greens declined with time when treated 

with the 240SC formulation. 

Total Spirotetramat Residue Levels (ppm) 

Commodity 

Total Rate 

 (kg a.i./ha) 

PHI 

(days) n Min. Max. HAFT Median Mean SD 

Broccoli/Cauliflower 

100OD 

0.173 -0.177 

1 13 0.099 0.451 0.423 0.369 0.336 0.110 

Flower head 

and stems 240 SC 

 0.176 1 4 0.210 0.325 0.307 0.289 0.278 0.048 

Cabbage 

100OD 

0.173-0.177 1 12 0.054 0.924 0.911 0.312 0.394 0.317 Heads with 

wrapper 

leaves 

240 SC 

 0.176 

1 2 0.050 0.050 0.050 0.050 0.050 NA 

100OD 

0.173-0.177 Heads with 1 10 0.052 0.170 0.164 0.095 0.097 0.041 

out wrapper 

leaves 

240 SC 

0.176 

1 2 0.055 0.056 0.056 0.056 0.056 NA 

Mustard Greens 

100 OD 

0.171- 0.184 

1 17 0.771 5.490 5.358 3.378 2.795 1.708 

Greens 

240 SC 

0.174 -0.176 

1 4 0.784 4.460 4.400 2.600 2.611 2.066 
- 315 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

CROP FIELD TRIALS ON CUCURBIT VEGETABLES PMRA # 1314489

GAP: Maximum seasonal rate of 175 g a.i./ha with a minimum interval of 7 days between applications and a PHI of 1 

day.

A total of 17 field trials were conducted in representative commodities of crop group 9 (cucumber, muskmelon and 

summer squash). An appropriate number of trials were conducted in the NAFTA representative growing regions. Two 

broadcast foliar applications of either BYI 08330 100 OD or BYI 08330 240 SC were applied at a target rate of 88 g 

a.i./ha/application, with a re-treatment interval of 5-7 days. Total seasonal application rates for all trials ranged from 165 

to 181 g a.i./ha for BYI 08330 100 OD and from 173 to 179 g a.i./ha for BYI 08330 240 SC. All spray mixtures included 

Dyne-Amic (0.5% v/v) as an adjuvant. Samples of each commodities were collected one day after the last application. In 

the decline trials, samples were collected at five intervals corresponding to PHIs of approximately 0, 1, 3, 7 and 10 days. 

Total spirotetramat residue levels were similar in cucumbers and muskmelons treated with the 100OD or 240SC 

formulations. However, total spirotetramat residues were higher in summer squash treated with the 100OD formulation. 

There was no apparent decline of residues in cucumber and muskmelon. However, a decline of residues was observed in 

summer squash when treated with the OD formulation from a 1 day PHI to a 7 day PHI. 

Total Spirotetramat Residue Levels (ppm) 

Commodity 

Total Rate 

(kg a.i./ha) 

PHI 

(days) n Min. Max. HAFT Median Mean SD 

Cucumber - 

100 OD 

0.165-0.181 1 12 

<0.050 0.076 0.075 0.050 0.057 0.011 

Cucumber - 

240 SC 

0.173-0.179 1 4 

<0.050 0.057 0.054 0.050 0.052 0 

Muskmelon100 OD 

0.165-0.181 1-2 12 

<0.050 0.134 0.098 0.054 0.063 0.024 

Muskmelon - 

240 SC 

0.173-0.179 1-2 4 

<0.050 0.163 0.113 0.060 0.083 0.053 

Summer 

Squash-100 

OD 

0.165-0.181 1 10 

<0.050 0.184 0.173 0.069 0.095 0.051 

Summer 

Squash - 240 

SC 

0.173-0.179 1 2 

<0.050 0.051 0.051 -- -- -- 

CROP FIELD TRIALS ON LEAFY VEGETABLES PMRA # 1314487 

GAP: Maximum seasonal rate of 175 g a.i./ha with a minimum interval of 7 days between application and a PHI of 3 days. 

A total of 24 field trials were conducted in order to investigate the magnitude of total BYI 08330 residues in/on 

representative commodities of crop group 4 (head and leaf lettuce, celery, and spinach). An appropriate number of trials 

were conducted in the NAFTA representative growing regions.Trials were conducted with either a 100 OD formulation or a 

240 SC formulation being applied twice at a target rate of 88 g a.i./ha with 5 to 8 days interval between treatments. The 

total seasonal application rate was 0.171 – 0.183 g a.i./ha. All applications were made using spray volumes of 83 to 189 

L/ha and Dyne-Amic (0.5%) as an adjuvant. Samples of head lettuce, leaf lettuce, celery and spinach were harvested 3 

days after the last treatment. In the decline trials, samples were collected at 0, 1, 3, 7, and 10-day PHIs. Total 

spirotetramat residues declined with increasing PHIs in head lettuce, leaf lettuce, celery and spinach. Residues were 

higher in leaf lettuce, celery and spinach when treated with the 100 OD formulation. Residue levels were similar in head 

lettuce (with and without wrapper leaves) when treated with the 100 OD or 240 SC formulated products. 
- 316 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Total Spirotetramat Residue Levels (ppm) 

Commodity 

Total Rate 

(kg a.i./ha) 

PHI 

(days) n Min. Max. HAFT Median Mean SD 

3 (with wrapper 

leaves) 

12 0.197 0.918 0.822 0.708 0.605 0.261 

Head Lettuce 

0.171-0.183 

100 OD 3 (without 

wrapper leaves)

10 0.111 0.385 0.383 0.167 0.203 0.101 

3 (with wrapper 

leaves) 

4 0.173 1.035 0.957 0.583 0.593 0.427 

Head Lettuce 0.171-0.181 

240 SC 3 (without 

wrapper leaves)

4 0.160 0.241 0.234 0.224 0.212 0.036 

 0.171-0.183 

100 OD 

3 12 0.188 1.676 1.604 0.831 0.882 0.449 

Leaf Lettuce 

0.171-0.181 

240 SC 

3 2 0.211 0.227 0.219 0.219 0.219 NA 

 0.171-0.183 

100 OD 

3 15 0.248 2.633 2.533 0.606 1.019 0.856 

Celery 

0.171-0.181 

240 SC 

3 4 0.402 0.490 0.465 0.424 0.435 0.040 

 0.171-0.183 

100 OD 

3 14 0.204 3.360 3.071 1.334 1.493 0.977 

Spinach 

 0.171-0.181 

240 SC 

3 2 2.338 2.654 2.496 2.496 2.496 NA 

CROP FIELD TRIALS ON CITRUS FRUITS PMRA #1314490 

US GAP: Two foliar sprays at 0.18 kg a.i./ha/application with a minimum retreatment interval of 21 days, for a maximum 

seasonal rate of 0.36 kg a.i./ha and a PHI of 1 day.

During the 2005 growing season, trials were conducted on representative commodities of crop group 10 (orange, lemon, 

grapefruit). An appropriate number of trials were conducted in the NAFTA representative growing regions. Two groundbased airblast spray applications of either BYI08330 150 OD or BYI08330 240 SC were made at rates that ranged from 

0.168 to 0.187 kg a.i./ha/application, for a total seasonal rate of from 0.344 to 0.360 kg a.i./ha/season. The interval 

between applications ranged from 14 to 21 days. All spray mixtures included Dyne-Amic adjuvant (0.25% v/v). Samples of 

oranges, lemons and grapefruits were harvested at a preharvest interval (PHI) of 1 day. In decline trials, samples were 

collected at five intervals corresponding to PHIs of 0, 1, 7, 10, and 14 days. Additional orange samples were collected to 

determine the effect of peeling. Most of the residues in oranges appeared to be associated with the peel since the levels 

decreased to below the LOQ when the peel was removed. Total spirotetramat residue levels were similar in commodities 

treated with the BYI 08330 150 OD formulation and the BYI 08330 240 SC formulation. However, total spirotetramat 

residues (maximum values) were higher in commodities treated with the concentrated spray. In decline trials, detectable 

residues dissipated slightly with increasing PHIs in orange, with no apparent decline in grapefruit and lemon. 

Total Spirotetramat Residue Levels (ppm) 

Commodity 

Total Rate 

(kg a.i./ha) 

PHI 

(days) n Min. Max. HAFT Median Mean SD 

Orange -150 OD 1 51 0.250 0.433 0.427 0.298 0.306 0.054 

Orange -240 SC 

0.344–0.360 

1 6 0.250 0.413 0.388 0.307 0.315 0.064 

Lemon -150 OD 1 20 0.251 0.465 0.456 0.300 0.321 0.063 

Lemon -240 SC 

0.344–0.360 

1 2 0.305 0.392 0.348 — — — 

Grapefruit -150 OD 1 24 0.250 0.351 0.344 0.250 0.260 0.027 

Grapefruit -240 SC 

0.344–0.360 

1 4 0.250 0.250 0.250 0.250 0.250 0 
- 317 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

CROP FIELD TRIALS ON FRUITING VEGETABLES PMRA #1314516 

GAP: Maximum seasonal rate of 175 g a.i./ha with a minimum interval of 7 days between applications and a PHI of 1 day.

A total of 21 trials were conducted in or on representative commodities of crop group 8 (tomatoes, bell and non-bell 

peppers). An appropriate number of trials were conducted in the NAFTA representative growing regions. At each test 

location, two broadcast foliar applications of BYI08330 100 OD or BYI08330 240 SC were made to tomatoes, bell peppers, 

or chili peppers at a target rate of 88 g a.i./ha/application for a total seasonal rate that ranged from 0.168 to 0.199 kg 

a.i./ha. Retreatment intervals were 5 to 7 days with a preharvest interval of 1 day. All spray mixtures included Dyne-Amic 

adjuvant. Total spirotetramat residue levels were higher in fruiting vegetables treated with the 100OD formulation in 

comparison to the 240SC formulation. In decline studies, samples were collected at PHIs of 0, 1, 3, 7 and 10 days. There 

was no clear trend of decline observed in the total spirotetramat residues (maximum values) in tomato, bell pepper, or nonbell pepper. 

Total Spirotetramat Residue Levels (ppm) 

Commodity 

Total Rate 

(kg a.i./ha) 

PHI 

(days) n Min. Max. HAFT Median Mean Std. Dev. 

Tomato-100 

OD 

1 24 0.060 0.227 0.214 0.137 0.139 0.049 

Tomato-240 SC 

0.168–0.199 

1 6 0.072 0.189 0.177 0.139 0.130 0.048 

Bell pepper-100 

OD 

0.168–0.199 1 12 0.156 0.682 0.655 0.299 0.351 0.182 

Bell pepper-240 

SC 

0.168–0.199 1 4 0.188 0.361 0.275 0.259 0.267 0.080

Chili pepper100 OD 

0.168–0.199 1 6 0.427 1.379 1.232 0.558 0.748 0.390

CROP FIELD TRIALS ON GRAPES PMRA #1314622 

GAP: Maximum seasonal rate of 220 g a.i./ha with a minimum interval of 30 days between applications and a PHI of 7 

days.

A total of 12 trials were conducted on grapes during the 2005 growing season. An appropriate number of trials were 

conducted in the NAFTA representative growing regions.Test substance BYI 08330-150 OD or 240 SC was applied as a 

ground-based foliar spray at rates that ranged from 0.109 to 0.114 kg a.i./ha/application. The interval between applications 

ranged from 28 to 30 days. Total seasonal application rates for all trials ranged from 0.219 to 0.227 kg a.i./ha. All 

aplications were made in spray volumes of 458 to 654 L/ha and used Dyne-Amic (0.25% v/v) as an adjuvant. Samples were 

collected 7 days after the last application. In a decline trial, grapes treated with the 150 OD formulation were collected at 

five intervals corresponding to PHIs of 3, 7, 10, 14, and 21 days. Total spirotetramat residues were higher with the 150 OD 

formulation in comparison to the 240 SC formulation. Total spirotetramat residues did not appear to dissipate when the PHI 

increased from 3 to 21 days. 

Total Spirotetramat Residue Levels (ppm) 

Commodity 

Total Rate 

(kg a.i./ha) 

PHI 

(days) n Min. Max. HAFT Median Mean Std. Dev. 

Grape- 150 OD 0.219–0.227 7 24 0.109 1.290 1.024 0.329 0.406 0.257 

Grape- 240 SC 0.219–0.227 7 6 0.187 0.547 0.466 0.347 0.348 0.130 
- 318 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

CROP FIELD TRIALS ON HOPS PMRA # 1314494 

GAP: Maximum seasonal rate of 220 g a.i./ha with a minimum interval of 14 days between applications and a PHI of 7 

days.

Three field trials were conducted during the 2005 growing season. An appropriate number of trials were conducted in the 

NAFTA representative growing regions. At each test location, BYI08330 150 OD or BYI08330 240 SC was applied twice as 

a postemergent foliar spray at a rate of 0.108 to 0.112 kg a.i./ha/application with a retreatment interval of 12 to 14 days. 

The total application rate was from 0.218 to 0.224 kg a.i./ha/season. All spray mixtures included Dyne-Amic (0.25% v/v) as 

an adjuvant. Hop cones were harvested at preharvest interval of 7 days. Decline trials were conducted with samples 

collected at 7 and 14 days after the last application.Total spirotetramat residues were higher with the 150 OD formulation in 

comparison to the 240 SC formulation. Total spirotetramat residues declined slightly when the PHI increased from 7 to 14 

days. 

Total Spirotetramat Residue Levels (ppm) 

Commodity 

Total Rate 

(kg a.i./ha) 

PHI 

(days) n Min. Max. HAFT Median Mean Std. Dev. 

Hops- 150 OD 0.218–0.224 7 6 2.164 5.820 5.492 5.167 4.427 1.675 

Hops- 240 SC 0.218–0.224 7 2 3.149 4.512 3.830 — — — 

CROP FIELD TRIALS ON POME FRUITS PMRA # 1314492 

GAP: Maximum seasonal rate of 440 g a.i./ha with a minimum intervalof 14 days between applications and a PHI of 7 

days.

A total of 18 field trials were conducted on the representative commodities of crop group 11 (apples and pears) during the 

2005 growing season. An appropriate number of trials were conducted in the NAFTA representative growing regions. 

Applications of spirotetramat were made with one of two end-use products, BYI 08330 150OD or BYI 08330 240SC. 

Applied rates were 0.155 to 0.167 kg a.i./ha for the first application and 0.134 to 0.145 kg a.i./ha for the second and third 

applications, for a total of 0.430 to 0.447 kg a.i./ha/season with a 14 day re-treatment interval. All spray mixtures included 

Dyne-Amic adjuvant. Apples and pears were collected 7 days following the final application. Decline trials were conducted 

on apples and pears with samples collected at pre-harvest intervals of 0, 7, 14 and 21 days. Total spirotetramat residues 

were higher in apples and pears treated with the 150OD formulation. However, total spirotetramat residues were not 

significantly different between the application spray volumes (concentrated and dilute). Total spirotetramat residues in/on 

pome fruit declined with time. 

Total Spirotetramat Residue Levels (ppm) 

Commodity 

Total Rate 

(kg a.i./ha) 

PHI 

(days) n Min. Max. HAFT Median Mean Std. Dev. 

Apple-150 OD 0.430–0.447 7 44 0.052 0.375 0.344 0.126 0.148 0.090 

Apple-240 SC 0.430–0.447 7 6 0.062 0.144 0.143 0.075 0.094 0.039 

Pear-150 OD 0.430–0.447 7 22 0.063 0.373 0.344 0.175 0.177 0.086 

Pear-240 SC 0.430–0.447 7 4 0.137 0.259 0.250 0.196 0.197 0.062 

CROP FIELD TRIALS ON STONE FRUITS PMRA #1314485 

GAP: Maximum seasonal rate of 270 g a.i./ha with a minimum intervalof 14 days between applications and a PHI of 7 

days.

A total of 21 trials were conducted on the representative commodities of crop group 12 (cherries, peaches, plums). An 

appropriate number of trials were conducted in the NAFTA representative growing regions. At each test location, two 

airblast spray applications of BYI08330 150OD or BYI08330 240SC were made at rates from 0.156 to 0.165 kg 

a.i./ha/application for the first application and 0.107 to 0.112 kg a.i./ha/application for the second application for a total 

seasonal rate that ranged from 0.265 to 0.274 kg a.i./ha. All spray mixtures included the adjuvant Dyne-Amic (0.25% 

v/v).The retreatment interval was 12 to 15 days with a pre-harvest interval of 7 days. Decline trials were conducted with 

each commodity and the samples were collected at PHIs of 0, 7, 10, 14 and 21 days. Total spirotetramat residues were 

higher in cherries, peaches and plums treated with the 150OD compared to the 240 SC formulated products. The 

maximum total residues in plums were higher when treated with the concentrated spray. Total spirotetramat residues 

declined with increasing PHIs in cherries, but not in peaches or plums. 
- 319 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Total Spirotetramat Residue Levels (ppm) 

Commodity 

Total Rate 

(kg a.i./ha) 

PHI 

(days) n Min. Max. HAFT Median Mean Std. Dev. 

0.265-0.274 

Concentrated 

7 12 0.318 2.120 2.016 1.315 1.266 0.548 

Cherries – 150OD 

0.265-0.274 

Dilute 

7 12 0.222 2.127 2.044 1.602 1.480 0.564 

Cherries- 240SC 

0.265-0.274 

Concentrated 

7 2 0.572 0.645 0.608 0.608 0.608 - 

0.265-0.274 

Concentrated 

7 24 0.273 1.227 1.034 0.432 0.496 0.211 

Peaches – 

150OD 0.265-0.274 

Dilute 

7 14 0.414 1.142 1.109 0.692 0.692 0.217 

Peaches – 240SC 

0.265-0.274 

Concentrated 

7 6 0.339 0.809 0.668 0.560 0.539 0.178 

0.265-0.274 

Concentrated 

7 12 0.059 0.373 0.306 0.225 0.237 0.107 

Plum – 150OD 

0.265-0.274 

Dilute 

7 12 0.091 0.842 0.683 0.212 0.313 0.243 

Plum – 240SC 

0.265-0.274 

Concentrated 

7 2 0.060 0.065 0.062 0.062 0.062 - 

CROP FIELD TRIALS ON TREE NUTS PMRA #1314621 

GAP: Maximum seasonal rate of 380 g a.i./ha with a minimum interval of 14 days between applications and a PHI of 7 

days.

Ten field trials were conducted on the representative commodities of crop group 14 (almonds and pecans). An appropriate 

number of trials were conducted in the NAFTA representative growing regions. At each test location, three ground based 

airblast spray applications of either BYI08330 150 OD or BYI08330 240 SC were made to tree nuts at rates that ranged 

from 0.155 to 0.162 kg a.i./ha/application for the first application, and from 0.107 to 0.114 kg a.i./ha/application for the 

second and third applications. Total seasonal application rates ranged from 0.369 to 0.386 kg a.i./ha with application 

intervals of 12 to 20 days and a preharvest interval of 7 days. All spray mixtures included Dyne-Amic (0.25% v/v) as an 

adjuvant. Decline trials were conducted with samples collected at 0, 6, 10, 13 and 21 days after the last application. Total 

spirotetramat residue levels were higher in tree nuts treated with the 150 OD formulation. However, there was no 

significant difference observed in total spirotetramat residues in tree nuts treated with concentrated or dilute spray 

volumes. Residues did not decline in almond or pecan nutmeat with increasing PHIs. 

Total Spirotetramat Residue Levels (ppm) 

Commodity 

Total Rate 

(kg a.i./ha) 

PHI 

(days) n Min. Max. HAFT Median Mean Std. Dev. 

Almond nutmeats150 OD 

7 20 0.050 0.143 0.128 0.075 0.081 0.031 

Almond nutmeats240 SC 

0.369–0.386 

7 4 0.063 0.083 0.078 0.072 0.072 0.008 

Almond Hulls150 OD 

7 20 1.261 5.145 4.988 2.466 2.931 1.333 

Almond Hulls- 240 

SC 

0.369–0.386 

7 4 1.923 5.260 4.579 2.919 3.255 1.627 

Pecans- 150 OD 7 20 0.050 0.297 0.295 0.053 0.105 0.087 

Pecans- 240 SC 

0.369–0.386 

7 2 0.052 0.078 0.065 — — — 
- 320 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex III – Calculations of MRLs with NAFTA Calculator 

General Considerations: 

The applicant is requesting registration for both SC and oil-dispersion (OD) formulations, along with different 

spray volume (concentrated and dilute). All of the field trials employed application with the OD formulation 

(100 OD or 150 OD) with side-by-side comparisons with the SC formulation (240 SC) conducted at a few 

locations for each of the proposed crops. The resulting data indicated that for some of the tested crops, 

residues were greater following application of the OD formulations as compared to the SC formulation; for 

the remaining crops, a relationship between formulation and residues was not discernable. It was 

determined that the SC residue data should be excluded from all MRL calculations as it is derived from a 

different distribution that of the OD residue data. However, in those cases where the SC formulation resulted 

in higher residues than the OD formulation, the SC data was included in the MRL calculations. As specified 

by the “Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP”, the field trial application 

rates and PHIs must be within 25% of the maximum label application rate and minimum label PHI, 

respectively to be included. However, when the total residue of spirotetramat at earlier or later intervals 

(PHIs) exceeded the total residue at the critical GAP, then the higher values were evaluated to cover the 

worst case residue. The residue values consisted of the total of spirotetramat, BYI 08330-enol, BYI 08330-

ketohydroxy, BYI 08330-mono-hydroxy and BYI 08330-enol-Glc, as parent equivalents. 

MRL calculations were conducted on all representative crops of a crop group and the highest MRL output

was used to determine the MRL for the crop group. The rounding procedure was done as outlined in the 

“Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP”.
- 321 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

TABLE XX Proposed MRL Values for Spirotetramat 

RAC EP PHI 

(days)

Vol 

(L/ha) 

n min 

(ppm)

max 

(ppm)

median

(ppm) 

mean 

(ppm) 

NAFTA 

MRL 

(ppm) 

EU-MRL 

(ppm) 

Calc. 

Method 

NAFTA 

Rate 

(g a.i./ha)

EU Rate 

(g a.i./ha)

Broc/Cauli 100 OD 1 102 to 188 13 0.099 0.45 0.37 0.34 0.70 1 Cal 177 72 

Cabbage WW 100 OD 1 102 to 188 12 0.05 0.92 0.31 0.39 2.5 0.5 UClmed 177 72 

Cabbage NW 100 OD 1 102 to 188 10 0.05 0.17 0.09 0.10 0.25 0.5 NAFTA I 177 72 

Mustard 100 OD 1 102 to 188 17 0.77 5.5 3.38 2.80 8.0 Cal 187 72 

Crop Group MRL CG5A = 1.0 ppm CG5B = 8.0 ppm 

Orange 150 OD 1 375–653 27 <0.25 0.43 0.32 0.32 0.60 0.5 Cal 360 288 

Lemon 150 OD 1 375–653 10 0.277 0.46 0.35 0.35 0.60 0.5 NAFTA I 360 288 

grapefruit 150 OD 1 375–653 12 <0.25 0.34 0.25 0.27 0.40 0.5 Cal 360 288 

Crop Group 10 MRL 0.60 

Cucumber 100 OD 1 102–184 13 0.05 0.08 0.05 0.06 0.09 0.2 Cal 181 72 

Muskmelon SC 1-2 140–183 4 0.05 0.16 0.06 0.08 0.17 0.2 Rounding 179 72 

Squash 100 OD 1 102–184 11 0.05 0.18 0.06 0.09 0.30 NAFTA I 181 

Crop Group 9 MRL 0.30 

tomato 100 OD 1 101–182 24 0.06 0.23 0.14 0.14 0.35 2 green NAFTA I 199 144 grhs

Pepper 100 OD 1 101–182 12 0.16 0.68 0.30 0.35 1.1 2 NAFTA I 199 144 

Cayenne 100 OD 1 101–182 6 0.43 1.4 0.56 0.75 2.5 NAFTA I 199 

Crop Group 8 MRL 2.5 ppm 

Grape 150 OD 7 458–654 24 0.11 1.3 0.33 0.41 1.3 1 NAFTA I 227 96 

Hops 150 OD 7 458–654 6 2.2 5.8 5.2 4.4 10 10 Cal 224 150--300

Lettuce head 100 OD 3 83–189 12 0.20 0.92 0.71 0.60 1.4 5 Cal 183 72 

Lettuce inner 100 OD 3 83–189 10 0.11 0.38 0.17 0.20 0.60 5 NAFTA I 183 72 

Leaf lettuce 100 OD 3 83–189 12 0.19 1.7 0.83 0.88 2.5 Cal 183 72 

Celery stalk 100 OD 3 83–189 15 0.25 2.6 0.61 1.0 4.5 NAFTA I 183 72 

Spinach 100 OD 3 83–189 14 0.20 3.4 1.3 1.5 9.0 NAFTA I 183 72 

Crop Group 4 MRL CG = 9.0 

Apple 150 OD 7 327–654 24 0.052 0.37 0.13 0.15 0.50 0.3 NAFTA I 447 216 

Pear 150 OD 7 327–654 12 0.08 0.41 0.20 0.20 0.70 0.3 NAFTA I 447 216 

Crop Group 11 MRL 0.70 ppm 

Potato (1C) 150 OD 7 121–191 34 0.05 0.46 0.12 0.17 0.60 NAFTA I 180 

Cherry 150 OD 7 365–681 12 0.32 2.1 1.3 1.3 4.5 2 NAFTA I 274 216 

Peach 150 OD 7 1960–3662 22 0.27 1.1 0.56 0.62 1.4 2 NAFTA I 274 216 

Plum 150 OD 7 1960–3662 12 0.09 0.84 0.21 0.31 1.5 2 NAFTA I 274 216 

Crop Group 12 MRL CG = 4.5 ppm 

Almond nut 150 OD 7 337–634 10 0.05 0.14 0.08 0.09 0.25 NAFTA I 386 

Pecan 150 OD 7 1883–2865 10 0.05 0.30 0.05 0.12 

0.25 

(MLE) Cal 386 

Crop Group 14 MRL CG=0.25 ppm 
- 322 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Leafy Brassica Greens (5A); Head and Stem Brassica (5B)

The dataset used to establish an MRL for spirotetramat in/on Head and Stem Brassica, subgroup 5A

consisted of cabbage field trial data representing application rates of 0.172- 0.177 kg a.i./ha (heads with 

wrapper leaves, 100 OD formulation) with a 1-day PHI. All 12 field trial sample results were above the 

combined LOQ of 0.05 ppm. Since there were no values (combined residues) reported below the LOQ, 

maximum-likelihood estimation (MLE) procedures were not needed to impute censored values. Visual 

inspection of the lognormal probability plot provided in the spreadsheet indicates that the dataset is

reasonably lognormal. The result from the approximate Shapiro-Francia test statistic confirmed that the 

assumption of lognormality should not be rejected. Based on the 95% UCL on the 95th percentile and the 

point estimate of the 99th percentile, the value is rounded to 2.5 ppm. Therefore, 2.5 ppm is the 

recommended MRL level for spirotetramat in/on Head and Stem Brassica (subgroup 5A). 

The dataset used to establish an MRL for spirotetramat in/on Leafy Brassica Greens, subgroup 5B

consisted of mustard greens field trial data representing application rates of 0.171- 0.1864 kg a.i./ha(100 OD 

formulation) with a 1-day PHI. All 17 field trial sample results were above the combined LOQ of 0.05 ppm. 

Since there were no values (combined residues) reported below the LOQ, MLE procedures were not needed 

to impute censored values. Visual inspection of the lognormal probability plot provided in the spreadsheet 

indicates that the dataset is not lognormal. The result from the approximate Shapiro-Francia test statistic 

confirmed that the assumption of lognormality should be rejected. Using the CA Method and the μ + 3σ , the 

value rounds to 8.0 ppm. Therefore, 8.0 ppm is the recommended MRL level for spirotetramat in/on Leafy 

Brassica greens, subgroup 5B. 

CABBAGE

Regulator:Cabbage 100OD phi 1

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 12

min: 0.05

max: 0.92

median; 0.31

average: 0.39

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 1.0 1.2 1.4

Normal (1.3) (1.6) (--)

1.5 3.0 7.0

(4.5) (12) (--)

1.3

1.4

UPLMedian 95th 2.5

0.9426

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
- 323 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

MUSTARD GREENS

Citrus

The dataset used to establish an MRL for spirotetramat in/on citrus fruit, group 10 consisted of lemon field 

trial data representing application rates of 0.343-0.360 kg a.i./ha (concentrated spray, 100 OD formulation) 

with a 1-day PHI. All 10 field trial sample results were above the combined LOQ of 0.05 ppm. Since there 

were no values (combined residues) reported below the LOQ, MLE procedures were not needed to impute 

censored values. Visual inspection of the lognormal probability plot provided in the spreadsheet indicates 

that the dataset is reasonably lognormal. The result from the approximate Shapiro-Francia test statistic 

confirmed that the assumption of lognormality should not be rejected. Using the lognormal EU Method I and 

the point estimate of the 95th percentile, the value is rounded to 0.60 ppm. Therefore, 0.60 ppm is the 

recommended MRL level for spirotetramat in/on citrus fruit (group 10). 

Regulator:Mustard 100OD phi 1

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 17

min: 0.77

max: 5.49

median; 3.38

average: 2.80

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 6.0 7.0 9.0

Normal (8.0) (9.0) (--)

8.0 13 25

(15) (30) (--)

9.0

8.0

UPLMedian 95th 25

0.8789

0.05 >= p-value > 0.01 : Reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
- 324 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 LEMON

Cucurbit Vegetables

The dataset used to establish MRLs for spirotetramat in/on cucurbit vegetable, group 9 consisted of 

summer squash field trial data representing application rates of 0.165-0.180 kg a.i./ha (100 OD formulation) 

with a 1-day PHI. All but one of the 10 field trial sample values were above the combined LOQ of 0.05 ppm. 

Since only one value (combined residues) was reported below the LOQ, MLE procedures were not needed 

to impute censored values. Visual inspection of the lognormal probability plot provided in the spreadsheet 

indicates that the dataset is reasonably lognormal. The result from the approximate Shapiro-Francia test 

statistic confirmed that the assumption of lognormality should not be rejected. Using the lognormal EU 

Method I and the point estimate of the 99th percentile, the value is rounded to 0.30 ppm. Therefore, 0.30 ppm 

is the recommended MRL level for spirotetramat in/on cucurbit vegetable (group 9). 

Regulator:Lemon 150 OD conc phi 1

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 10

min: 0.27

max: 0.47

median; 0.31

average: 0.34

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 0.50 0.50 0.60

Normal (0.60) (0.70) (--)

0.50 0.60 0.60

(0.60) (0.80) (--)

0.80

0.60

UPLMedian 95th 3.0

0.8871

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
- 325 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

SUMMER SQUASH

Fruiting Vegetables

The dataset used to establish an MRL for spirotetramat in/on fruiting vegetable (group 8) consisted of nonbell pepper field trial data representing application rates of 0.168-0.199 kg a.i./ha (100 OD formulation) with a 

1-day PHI. All 6 field trial sample results were above the combined LOQ of 0.05 ppm. Since there were no 

values (combined residues) reported below the LOQ, MLE procedures were not needed to impute censored 

values. The spirotetramat non-bell pepper dataset was entered into the MRL spreadsheet. Visual inspection 

of the lognormal probability plot provided in the spreadsheet indicates that the dataset is reasonably

lognormal. The result from the approximate Shapiro-Francia test statistic confirmed that the assumption of 

lognormality should not be rejected. Using the lognormal EU Method I and the point estimate of the 99th

percentile, the value is rounded to 2.5 ppm. Therefore, 2.5 ppm is the recommended MRL level for 

spirotetramat in/on fruiting vegetable (group 8). 

Regulator: Summer Squash 100 OD phi 1

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 11

min: 0.05

max: 0.18

median; 0.06

average: 0.09

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 0.20 0.25 0.25

Normal (0.25) (0.30) (--)

0.20 0.30 0.40

(0.35) (0.60) (--)

0.30

0.25

UPLMedian 95th 0.50

0.8565

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
- 326 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

NON-BELL PEPPER 

Grapes

The dataset used to establish an MRL for spirotetramat in/on grape consisted of field trial data representing 

application rates of 0.218–0.227 kg a.i./ha (100 OD formulation) with a 7-day PHI. 

All 24 field trial sample results were above the combined LOQ of 0.05 ppm. Since there were no values

(combined residues) reported below the LOQ, MLE procedures were not needed to impute censored values. 

The spirotetramat grape dataset was entered into the MRL spreadsheet. Visual inspection of the lognormal 

probability plot provided in the spreadsheet indicates that the dataset is reasonably lognormal. The result 

from the approximate Shapiro-Francia test statistic confirmed that the assumption of lognormality should not 

be rejected. Using the lognormal EU Method I and the point estimate of the 95th percentile, the value is 

rounded to1.3 ppm. Therefore, 1.3 ppm is the recommended MRL level for spirotetramat in/on small fruit vine 

climbing, except fuzzy kiwifruit (subgroup 13-07F). 

Regulator:Cayane 100 OD phi 1

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 6

min: 0.43

max: 1.38

median; 0.56

average: 0.75

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 1.4 1.7 2.0

Normal (2.5) (3.0) (--)

1.5 2.5 3.0

(4.0) (8.0) (--)

2.5

2.0

UPLMedian 95th 7.0

0.8749

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
- 327 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

GRAPE

Hops

The dataset used to establish an MRL for spirotetramat in/on hops consisted of field trial data representing 

application rates of 0.217–0.224 kg a.i./ha (100 OD formulation) with a 7-day PHI. All 6 field trial sample 

results were above the combined LOQ of 0.05 ppm. Since there were no values (combined residues) 

reported below the LOQ, MLE procedures were not needed to impute censored values. The spirotetramat 

hop dataset was entered into the MRL spreadsheet. Visual inspection of the lognormal probability plot 

provided in the spreadsheet indicates that the dataset is not reasonably lognormal. The result from the 

approximate Shapiro-Francia test statistic confirmed that the assumption of lognormality should be rejected. 

Using the CA Method and the μ + 3σ, the value rounds to 10 ppm. Therefore, 10 ppm is the recommended 

MRL level for spirotetramat in/on hops (dried). 

Regulator: grape 150 OD phi 7

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 24

min: 0.11

max: 1.29

median; 0.33

average: 0.41

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 0.90 1.1 1.3

Normal (1.1) (1.3) (--)

0.90 1.3 2.0

(1.3) (2.5) (--)

1.0

1.2

UPLMedian 95th 2.0

0.9601

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
- 328 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

HOPS

Leafy Vegetables

The dataset used to establish an MRL for spirotetramat in/on leafy vegetable, except Brassica, (group 4)

consisted of spinach field trial data representing application rates of 0.170-0.183 kg a.i./ha (100 OD

formulation) with a 3-day PHI. All 14 field trial sample results were above the combined LOQ of 0.05 ppm. 

Since there were no values (combined residues) reported below the LOQ, MLE procedures were not needed 

to impute censored values. The spirotetramat spinach dataset was entered into the MRL spreadsheet. Visual 

inspection of the lognormal probability plotprovided in the spreadsheet indicates that the dataset is 

reasonably lognormal. The result from the approximate Shapiro-Francia test statistic confirmed that the 

assumption of lognormality should not be rejected. Using the EU Method I and the point estimate of the 99th

percentile, the value is rounded to 9.0 ppm. Therefore, 9.0 ppm is the recommended MRL level for 

spirotetramat in/on leafy vegetable, except Brassica (group 4). 

Regulator: Hops 150 OD phi 7

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 6

min: 2.16

max: 5.82

median; 5.17

average: 4.43

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 8.0 9.0 10

Normal (11) (13) (--)

9.0 12 17

(25) (45) (--)

12

10

UPLMedian 95th 60

0.7728

0.05 >= p-value > 0.01 : Reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
- 329 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

SPINACH

Pome Fruits

The dataset used to establish an MRL for spirotetramat in/on pome fruit, pome (group 11) consisted of 

pear field trial data representing application rates of 0.430–0.447 kg a.i./ha (concentrated spray, 100 OD 

formulation) with a 7-day PHI. All 12 field trial sample results were above the combined LOQ of 0.05 ppm. 

Since there were no values (combined residues) reported below the LOQ, MLE procedures were not needed 

to impute censored values. The spirotetramat pear dataset was entered into the MRL spreadsheet. Visual

inspection of the lognormal probability plot provided in the spreadsheet indicates that the dataset is

reasonably lognormal. The result from the approximate Shapiro-Francia test statistic confirmed that the 

assumption of lognormality should not be rejected. Using the EU Method I and the point estimate of the 99th

percentile, the value is rounded to 0.70 ppm. Therefore, 0.70 ppm is the recommended MRL level for 

spirotetramat in/on pome fruit, group 11. 

Regulator:spinach 100 OD phi 3

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 14

min: 0.20

max: 3.36

median; 1.33

average: 1.47

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 3.5 4.0 4.5

Normal (4.0) (5.0) (--)

5.0 9.0 17

(12) (30) (--)

5.0

4.5

UPLMedian 95th 10

0.8880

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
- 330 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

PEAR

Potatoes

The dataset used to establish an MRL for spirotetramat in/on tuberous and corm vegetable, subgroup 1C

consisted of potato field trial data representing application rates of ~0.179 kg a.i./ha (100 OD formulation) 

with a 7-day PHI. All but two of the 32 field trial sample values were above the combined LOQ of 0.05 ppm. 

Since only two values (combined residues) were reported below the LOQ, MLE procedures were not needed 

to impute censored values. The spirotetramat lemon dataset was entered into the MRL spreadsheet. Visual 

inspection of the lognormal probability plot provided in the spreadsheet indicates that the dataset is

reasonably lognormal. The result from the approximate Shapiro-Francia test statistic confirmed that the 

assumption of lognormality should not be rejected. Using the lognormal EU Method I and the point estimate 

of the 95th percentile, the value is rounded to 0.60 ppm. Therefore, 0.60 ppm is the recommended MRL level 

for spirotetramat in/on tuberous and corm vegetable (subgroup 1C). 

Regulator:pear 150 OD conc phi 7

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 12

min: 0.08

max: 0.41

median; 0.20

average: 0.20

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 0.40 0.50 0.60

Normal (0.60) (0.70) (--)

0.45 0.70 1.0

(0.90) (1.5) (--)

0.70

0.60

UPLMedian 95th 1.5

0.9533

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
- 331 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

POTATOES

Stone Fruits

The dataset used to establish an MRL for spirotetramat in/on stone fruit, group 12 consisted of cherry field 

trial data representing application rates of 0.264-0.273 kg a.i./ha (concentrated spray, 100 OD formulation) 

with a 7-day PHI. All 12 field trial sample results were above the combined LOQ of 0.05 ppm. Since there 

were no values (combined residues) reported below the LOQ, MLE procedures were not needed to impute 

censored values. The spirotetramat cherry dataset was entered into the MRL spreadsheet. Visual inspection 

of the lognormal probability plot provided in the spreadsheet indicates that the dataset is reasonably

lognormal. The result from the approximate Shapiro-Francia test statistic confirmed that the assumption of 

lognormality should not be rejected. Using the EU Method I and the point estimate of the 99th percentile, the 

value rounds to 4.5 ppm. Therefore, 4.5 ppm is the recommended MRL level for spirotetramat in/on stone

fruit (group 12). 

Regulator:potato 150 OD phi 7

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 34

min: 0.05

max: 0.46

median; 0.12

average: 0.17

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 0.40 0.50 0.60

Normal (0.45) (0.60) (--)

0.40 0.70 1.1

(0.60) (1.0) (--)

0.45

0.60

UPLMedian 95th 0.70

0.9389

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
- 332 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

CHERRIES

Tree Nuts

The dataset used to establish an MRL for spirotetramat in/on tree nut, group 14 consisted of pecan field trial 

data representing application rates of 0.368-0.385 kg a.i./ha (dilute spray, 100 OD formulation) with a 7-day 

PHI. As 6 of 10 field trial sample results were below the combined LOQ of 0.05 ppm, MLE procedures were 

needed to impute censored values. The spirotetramat pecan dataset was entered into the MRL spreadsheet. 

Visual inspection of the lognormal probability plot provided in the spreadsheet indicates that the dataset is 

reasonably lognormal. The result from the approximate Shapiro-Francia test statistic confirmed that the 

assumption of lognormality should not be rejected. Using the UPL Median 95th percentile, the value is 

rounded to 0.25 ppm. Therefore, 0.25 ppm is the recommended MRL level for spirotetramat in/on tree nut 

(group 14). 

Regulator:cherry 150 OD conc 7

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 12

min: 0.32

max: 2.12

median; 1.32

average: 1.27

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 2.5 3.0 3.0

Normal (3.0) (3.5) (--)

3.0 4.5 7.0

(6.0) (9.0) (--)

3.5

3.0

UPLMedian 95th 10

0.8921

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
- 333 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

PECAN

Strawberries (import only)

The dataset used to establish an MRL for spirotetramat in/on strawberry consisted of field trial data 

representing application rates of ~0.19 kg a.i./ha (greenhouse, 100 OD formulation) with a 7-day PHI. All 8 

field trial sample results were above the combined LOQ of 0.05 ppm. Since there were no values (combined 

residues) reported below the LOQ, MLE procedures were not needed to impute censored values. The 

spirotetramat strawberry dataset was entered into the MRL spreadsheet. Visual inspection of the lognormal 

probability plot provided in the spreadsheet indicates that the dataset is reasonably lognormal. The result 

from the approximate Shapiro-Francia test statistic confirmed that the assumption of lognormality should not 

be rejected. Using the EU Method I and the point estimate of the 99th percentile, the value rounds to 0.40 

ppm. Therefore, 0.40 ppm is the recommended MRL level for spirotetramat in/on strawberries. 

Regulator: Pecan Nutment dilute Spray OD with MLE

Chemical:

Crop:

PHI:

App. Rate:

Submitter:

n: 10

min: 0.00

max: 0.30

median; 0.03

average: 0.10

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 0.30 0.40 0.50

Normal (0.45) (0.60) (--)

0.60 1.6 6.0

(4.0) (25) (--)

0.40

0.50

UPLMedian 95th 0.25

0.9419

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
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STRAWBERRY (EU)

Dry Bulb Onions (import only)

The dataset used to establish an MRL for spirotetramat in/on dry bulb onion, subgroup 3-07A consisted of 

field trial data representing application rates of ~0.29 kg a.i./ha (Northern EU, 100 OD formulation) with a 7-

day PHI. All 8 field trial sample results were above the combined LOQ of 0.05 ppm. Since there were no 

values (combined residues) reported below the LOQ, MLE procedures were not needed to impute censored 

values. The spirotetramat strawberry dataset was entered into the MRL spreadsheet. Visual inspection of the 

lognormal probability plot provided in the spreadsheet indicates that the dataset is reasonably lognormal. 

The result from the approximate Shapiro-Francia test statistic confirmed that the assumption of lognormality 

should not be rejected. Using the EU Method I and the point estimate of the 99th percentile, the value rounds 

to 0.30 ppm. Therefore, 0.30 ppm is the recommended MRL level for spirotetramat in/on dry bulb onions. 

Regulator: EU

Chemical: SPA

Crop:Strawberry Greenhouse

PHI: 7

App. Rate: 192 g as/ha

Submitter:

n: 8

min: 0.21

max: 0.33

median; 0.28

average: 0.27

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 0.35 0.40 0.40

Normal (0.40) (0.45) (--)

0.35 0.40 0.45

(0.45) (0.60) (--)

0.70

0.40

UPLMedian 95th 3.0

0.9451

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

DRY BULB ONIONS

Regulator: EU

Chemical: Spirotetramat

Crop: Onion Northern EU

PHI: 7

App. Rate: 288 g ai/ha of 100 or 150OD 

Submitter:

n: 8

min: 0.05

max: 0.20

median; 0.10

average: 0.11

95th Percentile 99th Percentile 99.9th Percentile

EU Method I 0.20 0.25 0.30

Normal (0.30) (0.35) (--)

0.25 0.30 0.40

(0.40) (0.70) (--)

0.30

0.30

UPLMedian 95th 1.0

0.9558

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Log Normal

EU Method II

Distribution-Free

California Method

μ + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Annex III: Import tolerances (evaluation document of UK): 

MRL PROPOSALS FOR SPIROTETRAMAT [NEW ACTIVE SUBSTANCE; OECD WORK SHARING 

PROJECT] 

EU RAPPORTEUR MEMBER STATE: AUSTRIA 

February 2008 

Introduction 

This MRL proposal results from an OECD work sharing project for the new active substance spirotetremat. 

A range of uses are proposed both in the EU and in the USA, Canada and Mexico (NAFTA countries). 

Different components of the data evaluation have been performed by AGES (Austria), EPA (USA), PMRA 

(Canada) and PSD (UK). This document provides an overview of GAPs and residues data in support of EU 

MRLs to be established in Regulation 396/2005. The assessment considers data and GAPs for both EU and

NAFTA and proposes MRLs on the basis of the most critical data and GAP for each use, subject to 

acceptable consumer risk assessment. 

 

Acceptable Daily Intake (ADI) for spirotetramat 

Set by US EPA and AGES (2007) 

ADI 0.05 mg/kg bw/day 

NOAEL 5 mg/kg bw/day 

Study type 1 year dog study. 

Set by PMRA, Canada (2007) 

ADI 0.03 mg/kg bw/day 

NOAEL 1 mg/kg bw/day 

Study type Teratogenicity rabbit study. 

Acute Reference Dose (ARfD) for spirotetramat 

Set by US EPA, PMRA, Canada (2007) and AGES (2008) 

ARfD 1 mg/kg bw/day 

NOAEL 100 mg/kg bw/day 

Study type acute neurotox rat study 

Residue definition for spirotetramat 

The residue definition for plants for monitoring and risk assessment is ‘Sum of spirotetramat, BYI08330-enol, 

BYI08330-ketohydroxy, BYI08330-monohydroxy, and BYI08330 enol-glucoside, expressed as spirotetramat’. 

Limits of determination 

0.02 mg/kg for plants (total residue) 

0.01-0.05 mg/kg for products of animal origin 

Trial selection 

For all trials, the residue value corresponding to the notified GAP was used, unless for decline trials, the 

residue value was higher at a longer PHI. For NAFTA trials, several plots were sampled from the same sites 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

each year, with replicate samples from each plot reported. Plots on each site were also sprayed with 

different formulations. In all cases, only a single residue value from each site for each year was used for 

MRL calculations. The selected value was the highest single replicate value for that site. 

GAP tables are given in Appendix 1 and details of all trials are given in Appendix 2. 

ASSESSMENT OF CONSUMER RISK 

Both acute and chronic intake resulting from the proposed uses have been calculated using the EFSA 

consumer risk assessment model. A first tier assessment using proposed MRL values indicates a maximum

of 68% of the ARfD (Kale) and a total chronic intake of 77% of the ADI (German child). All proposed MRLs 

are therefore regarded as acceptable for consumers and no further refinement of the risk assessment is

required. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Commodity Codex EU 

Proposed 

STMR (mg/kg) 

Remarks Comments by RMS Austria: 

1. FRUIT FRESH OR FROZEN; NUTS  (i) Citrus fruit 1 0.34 GAP in EU-S: 2x0.096 kg as./ha, 14 day PHI 

GAP NAFTA:2x0.180 kg as./ha, 1 day PHI NAFTA data critical. Oranges and lemon combined for group tolerance. Lemon data appear to be higher 

than oranges and therefore suitable alternative to mandarin for group tolerance. Rmax = 0.52 Rber = 0.78 

Proposal by Canada: 0.6 mg/kg; difference between the two proposals based on different calculation-models and/or MRL-classes. 

 Grapefruit RESIDUE TRIALS 

EU No data NAFTA 0.26; <0.25; <0.25; <0.25; 0.35; <0.25 

 Oranges RESIDUE TRIALS 

EU-S 0.06; 0.06; 0.06; 0.07; 0.08; 0.11; 0.12; 0.23 NAFTA 0.42; <0.25; 0.38; 0.34; 0.43; <0.25; 0.32; 0.34; <0.25 

 Lemons RESIDUE TRIALS 

NAFTA 0.28; 0.36; 0.47; 0.33; 0.34 

 Limes 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Mandarins RESIDUE TRIALS 

EU-S 0.14; 0.15; 0.17; 0.19; 0.21; 0.23; 0.23; 0.27; 0.33 

NAFTA No data 

 Others1  (ii) Tree nuts (shelled or unshelled) 

 0.5 0.07 No GAP in EU 

GAP NAFTA: 2x0.19 kg as/ha, 7 days PHI. Almonds and pecans combined for group tolerance Rmax = 0.34 Rber = 0.29 

Proposal by Canada: 0.25 mg/kg; difference between the two proposals based on different calculation-models and/or MRL-classes. Almond hulls 9 mg/kg (proposal Canada): not considered because no food item in EU. 

 Almonds RESIDUE TRIALS 

NAFTA <0.05; 0.14; 0.08; 0.06; 0.14 mg/kg 

 Brazil nuts  Cashew nuts  Chestnuts  Coconuts  Hazelnuts  Macadamia  Pecans RESIDUE TRIALS 

NAFTA 0.06; <0.05; <0.05; 0.16; 0.30 mg/kg 

 Pine nuts  Pistachios  Walnuts  Others2 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 (iii) Pome fruit 0.5 0.18 GAP in EU-N and S: 2x0.072 kg as /ha, 21 day PHI 

GAP NAFTA: 3x0.150 kg as/ha, 7 days PHI NAFTA data critical. Apples and pears combined for

group tolerance Rmax = 0.45 Rber = 0.50 

1 mg/kg might be more appropriate; covering Canada’s proposal of 0.7 mg/kg). 

 Apples RESIDUE TRIALS 

EU-S (critical data) 0.05; 0.10; 0.10; 0.13; 0.14; 0.19 NAFTA 0.06; 0.17; 0.14; 0.13; 0.08; 0.07; 0.38; 0.37; 0.34; 0.18; 

0.18; 0.12 

 Pears RESIDUE TRIALS 

EU-S critical data 0.05; 0.07; 0.07; 0.14; 0.15; 0.25 NAFTA 0.12; 0.37; 0.21; 0.22; 0.22; 0.11; 

 Quinces  Medlar  Loquat  Others3  (iv) Stone fruit GAP in EU-N and S: 2x0.072 kg as /ha, 21 day PHI

GAP NAFTA: 2x0.140 kg as/ha, 7 days PHI 

 Apricots 2 0.70 RESIDUE TRIALS 

EU-S critical data 0.27; 0.28; 0.29; 0.68; 0.69 Extrapolation from NAFTA peach data 

Extrapolation from NAFTA peach data Canada’s proposal: 4.5 mg/kg (group tolerance stone fruits – based on cherry data?) 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Cherries 5 1.63 RESIDUE TRIALS 

EU-N Sweet cherry critical data: 0.52; 0.58; 0.83; 0.94;EU-S Sweet cherry critical data: 0.63; 0.68; 0.72; 1.05 Data can be combined, no significant difference between 

N and S NAFTA 2.13; 1.63; 2.12; 0.75; 1.63; 1.63 NAFTA data critical. Rmax = 3.51 Rber = 4.25 

Canada’s proposal: 4.5 mg/kg (group tolerance stone fruits); difference between the two proposals based on different calculation-models and/or MRL-classes. 

 Peaches 2 0.70 RESIDUE TRIALS 

EU-S critical data 0.12; 0.17; 0.31; 0.35 NAFTA 0.70; 0.56; 0.53; 0.82; 0.69; 1.23; 0.69; 0.77; 0.77 

NAFTA data critical. Rmax = 1.37 Rber = 1.59 

Canada’s proposal: 4.5 mg/kg (group tolerance stone fruits – based on cherry data?) 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Plums 2 0.36 RESIDUE TRIALS 

EU-N 0.12; 0.15; 0.19; 0.35; 0.42; 0.51; 0.58; 0.83 NAFTA 0.84; 0.37; 0.23; 0.35; 0.11; 0.57 NAFTA data critical. (Major in N EU, but only 6 trials – ACCEPTABLE IF RISK LOW?) Rmax = 1.38 Rber = 1.28 

Based on 6 trials only (mafor crop in N-EU).. Proposal by Canada: 4.5 mg/kg; (group tolerance stone fruits – based on cherry data?) 

 Others4 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 (v) Berries & small fruit  (a) Table and wine grapes 2 0.36 GAP in EU- S: 2x0.096 kg as /ha, 14 day PHI

GAP NAFTA: 2x0.110 kg as /ha, 7 day PHI RESIDUE TRIALS (combined table and wine, no apparent 

difference) EU-S 0.48; 0.18; 0.26; 0.64; 0.28; 0.22; 0.17; 0.57; 0.20; 0.35 NAFTA 0.32; 0.79; 0.24; 0.29; 0.26; 0.11; 0.48; 0.50; 0.34; 0.47; 1.29; 0.38 NAFTA data critical. Rmax = 1.31 Rber = 0.99 

Proposal by Canada: 1.3 mg/kg; difference between the two proposals based on different calculation-models and/or MRL-classes. 

 Table grapes  Wine grapes 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 (b) Strawberries 1 0.28 GAP in EU-N, S and glasshouse: 2x0.096 kg as /ha, 3 

day PHI RESIDUE TRIALS EU-G 0.28; 0.21; 0.24; 0.33; 0.29; 0.23; 0.28; 0.30 EU-N 0.18; 0.16; 0.26; 0.21 EU-S 0.14; 0.15; 0.14; 0.11 EU Glasshouse data critical. Rmax = 0.40 Rber = 0.60 

No import tolerance, as no use intended within NAFTA. 

 (c) Cane fruit 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 Blackberries  Dewberries  Raspberries  Others5  (d) Other small fruit & berries 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 Blueberries  Cranberries  Currants (red, black and white)  Gooseberries  Rose hips  Mulberries 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Azarole (mediteranean medlar)  Elderberries  Others6  (vi) Miscellaneous fruit 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 (a) Edible peel  Dates  Figs  Table olives  Kumquats  Carambola  Persimmon  Jambolan (java plum)  Others7  (b) Inedible peel, small  Kiwi  Lychee (Litchi)  Passion fruit  Prickly pear (cactus fruit)  Star apple  American persimmon (Virginia kaki)  Others8  (c) Inedible peel, large  Avocados  Bananas  Mangoes  Papaya 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Pomegranate  Cherimoya  Guava  Pineapples  Bread fruit  Durian  Soursop (guanabana)  Others9 2. VEGETABLES FRESH OR FROZEN  (i) Root and tuber vegetables  (a) Potatoes 0.5 0.12 No GAP in EU 

GAP NAFTA: 0.18 kg as/ha, 7 days PHI. RESIDUE TRIALS NAFTA 0.41; 0.19; 0.25; 0.31; 0.17; 0.07; 0.45; 0.08; 0.10; <0.05; 

0.08; 0.07; 0.12; 0.17; 0.12; 0.08 Rmax = 0.48 Rber = 0.47 

Proposal doesn’t cover Canadas MRL of 0.6 mg/kg: difference between the two proposals based on different calculation-models and/or MRL-classes. 

 (b) Tropical root and tuber vegetables 

 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 Cassava  Sweet potatoes  Yams  Arrowroot  Others10  (c) Other root and tuber vegetables except sugar beet 

 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Beetroot  Carrots  Celeriac  Horseradish  Jerusalem artichokes  Parsnips  Parsley root  Radishes  Salsify  Swedes  Turnips  Others11  (ii) Bulb vegetables  Garlic  Onions 0.5 0.11 GAP in EU-N: 4x0.072 kg as /ha, 7 day PHI 

RESIDUE TRIALS EU-N 0.20; 0.10; 0.11; 0.11; 0.16; <0.05; 0.08; 0.09 EU-S 0.07; 0.12; 0.10; 0.17; 0.08; 0.09; 0.14; <0.05 EU-N data critical. Rmax = 0.26 Rber = 0.30 

No NAFTA GAP, therefore no import tolerance. 

 Shallots  Spring onions  Others12 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 (iii) Fruiting vegetables  (a) Solanacea  Tomatoes 2 0.44 GAP in EU-S and glasshouse: 4x0.072 kg as /ha, 3 day 

PHI GAP NAFTA: 2x0.090 kg as /ha, 1 day PHI RESIDUE TRIALS EU-G 0.44; 0.44; 0.74; 0.68; 0.51; 0.29; 0.34; 0.22 EU-S 0.19; 0.14; 0.12; 0.21 NAFTA 0.12; 0.11; 0.22; 0.08; 0.10; 0.23; 0.22; 0.14; 0.17; 0.11; 0.18; 0.14 EU-G data critical. Rmax = 1.04 Rber = 1.28 

No NAFTA GAP, therefore no import tolerance. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Peppers 2 0.48 GAP in EU-S and glasshouse: 4x0.072 kg as /ha, 3 day 

PHI GAP NAFTA: 2x0.090 kg as /ha, 1 day PHI RESIDUE TRIALS EU-G 0.57; 0.58; 0.43; 0.35; 0.55; 0.48; 0.27; 0.54; 0.48; 0.57; 0.31; 0.29 EU-S 0.82; 0.27; 0.21; 0.35; 0.14; 0.17; 0.11; 0.17 NAFTA Sweet pepper: 0.17; 0.28; 0.57; 0.36; 0.68; 0.32 Chilli pepper: 1.38; 0.58; 0.48 NAFTA data critical (combined sweet and chilli pepper). Rmax = 1.62 Rber = 1.26 

Corresponding to MRL-proposal based on critical EU-GAP (glasshouse). 

 Aubergines (egg plants) 2 0.44 GAP in EU-S and glasshouse: 4x0.072 kg as /ha, 3 day 

PHI Extrapolated from tomato 

 Okra, lady’s fingers  Others13 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 (b) Cucurbits - edible peel 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Cucumbers 0.2 0.06 GAP in EU-S and glasshouse: 4x0.072 kg as /ha, 3 day 

PHI GAP NAFTA: 2x0.090 kg as /ha, 1 day PHI RESIDUE TRIALS EU-G 0.08; 0.06; 0.07; 0.07; 0.08; <0.05; 0.06; 0.06 EU-S 0.06; <0.05; 0.06; 0.06; <0.05; <0.05; 0.12 NAFTA <0.05; 0.07; <0.05; <0.05; 0.06; 0.08 EU data critical (G and S data can be combined, no significant difference). Rmax = 0.11 Rber = 0.14 

Corresponding to MRL-proposal based on critical EU-GAP (glasshouse); Canada’s proposal: 0.3 mg/kg, difference based on different calculation models 

 Gherkins  Courgettes 0.2 0.06 GAP in EU-S and glasshouse: 4x0.072 kg as /ha, 3 day 

PHI Extrapolated from cucumber 

 Others14 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 (c) Cucurbits-inedible peel 0.3 0.06 GAP in EU-S and glasshouse: 4x0.072 kg as /ha, 3 day 

PHI GAP NAFTA: 2x0.090 kg as /ha, 1 day PHI NAFTA data critical. Melons and squashes combined for group tolerance. Rmax = 0.11 Rber = 0.14 

Corresponds to proposal by Canada. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Melons RESIDUE TRIALS 

EU-G <0.05; <0.05; 0.06; <0.05; <0.05; <0.05; 0.06; <0.05 

EU-S 0.08; <0.05; 0.09; <0.05; 0.08; 0.06; 0.06; <0.05; <0.05 

NAFTA 0.06; <0.05; 0.13; 0.08; 0.06; <0.05 

 Pumpkins RESIDUE TRIALS 

NAFTA 0.18; 0.05; 0.08; 0.06; 0.11 

 Watermelons  Others15  (d) Sweet corn 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 (e) Other fruiting vegetables  (iv) Brassica vegetables GAP in EU-N and S: 2x0.072 kg as /ha, 3 day PHI 

GAP NAFTA: 2x0.088 kg as /ha, 1 day PHI 

 (a) Flowering brassica 2 0.50 RESIDUE TRIALS (Data) 

EU-N 0.58; 0.43; 0.24; 0.38; 0.11; 0.22; 0.31; 0.37 EU-S 0.32; 0.26; 0.20; 0.13 NAFTA 0.87; 0.84; 0.55; 0.18; 0.35; 0.29; 0.54; 0.45 NAFTA data critical (combined for broccoli and cauliflower). Rmax = 1.30 Rber = 1.54 

Proposal by Canada: 2.5 mg/kg; difference between the two proposals based on different calculation-models and/or MRL-classes. 

 Broccoli 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Cauliflower  Others16  (b) Head brassica  Brussels sprouts 0.3 0.11 RESIDUE TRIALS 

EU-N 0.11; 0.09; 0.13; 0.22; 0.09; 0.09; 0.14; 0.11 Rmax = 0.26 Rber = 0.28 

No NAFTA GAP, therefore no import tolerance. 

 Head cabbage 2 0.24 RESIDUE TRIALS 

EU-N 0.10; 0.10; 0.09; 0.07; 0.13; 0.19; 0.08; 0.26; 0.09; 0.15 

EU-S 0.23; 0.11; 0.07; 0.07 NAFTA 0.07; 0.92; 0.06; 0.65; 0.24; 0.51; 0.19 NAFTA data critical Rmax = 1.30 Rber = 1.54 

Proposal by Canada: 2.5 mg/kg; difference between the two proposals based on different calculation-models and/or MRL-classes. 

 Others17 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 (c) Leafy brassica 10 3.70 RESIDUE TRIALS 

EU-N 0.62; 0.77; 0.24; 0.30 EU-S 0.56; 0.63; 0.31; 0.21 NAFTA 1.73; 5.49; 4.02; 5.60; 0.87; 0.86; 2.01; 3.38; 4.46; 4.29 

NAFTA data critical Rmax = 8.49 Rber = 9.44 

Proposal by Canada: 8.0 mg/kg; difference between the two proposals based on different calculation-models and/or MRL-classes. 

 Chinese cabbage  Kale  Others18  (d) Kohlrabi 5 0.47 RESIDUE TRIALS 

EU-N 1.43; 0.67; 0.27; 0.16 Rmax = 3.59 Rber = 2.48 

Wrong residue data. The correct data are : 0.152, 0.232, 0.554, 0.670 Rmax = 1.648 Rber = 1.282 HR 0.670 mg/kg STMR 0.393mg/kg MRL: 2 mg/kg 

 (v) Leaf vegetables & fresh herbs  (a) Lettuce and other salad plants including Brassicacea  Lamb's lettuce 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Lettuce 5 1.24 GAP in EU-N, S and glasshouse: 2x0.072 kg as /ha, 7 

day PHI RESIDUE TRIALS EU-G 1.06; 0.39; 1.76; 0.37; 1.84; 1.41; 0.16; 2.33; Rmax = 3.72 Rber = 3.64 

Intended for use in NAFTA, but no residue trials submitted. 

 Scarole (broad-leaf endive)  Cress  Land cress  Rocket, Rucola  Red mustard  Leaves and sprouts of Brassica spp  Others19 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 (b) Spinach & similar (leaves) 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 Spinach  Purslane  Beet leaves (chard)  Others20  (c) Vine leaves (grape leaves)  (d) Water cress 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 (e) Witloof 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 (f) Herbs 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 Chervil  Chives  Celery leaves  Parsley  Sage  Rosemary  Thyme  Basil  Bay leaves (laurel)  Tarragon  Others21  (vi) Legume vegetables (fresh)  Beans (with pods) 2 0.35 GAP in EU-glasshouse: 4x0.072 kg as /ha, 14 day PHI 

RESIDUE TRIALS EU-G 0.30; 0.12; 0.57; 0.56; 0.08; 0.21; 0.62; 0.40 Rmax = 1.03 Rber = 1.14 

 Beans (without pods)  Peas (with pods)  Peas (without pods)  Lentils  Others22 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 (vii) Stem vegetables (fresh) 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 Asparagus  Cardoons  Celery  Fennel  Globe artichokes  Leek  Rhubarb  Bamboo shoots  Palm hearts  Others23  (viii) Fungi 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 Cultivated  Wild  Others24  (ix). Sea weeds 3. PULSES, DRY 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 Beans  Lentils  Peas  Lupins  Others25 4. OILSEEDS AND OILFRUITS 0.05* No GAP  (i) Oilseeds  Linseed  Peanuts 
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Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Poppy seed  Sesame seed  Sunflower seed  Rape seed  Soya bean  Mustard seed  Cotton seed  Pumpkin seeds  Safflower  Borage  Gold of pleasure  Hempseed  Castor bean  Others26  (ii) Oilfruits  Olives for oil production  Palm nuts (palmoil kernels)  Palmfruit  Kapok  Others27 5. CEREALS 0.02* No GAP The LOQ of the analytical method is 

0.05 mg/kg for the total residue. 

 Barley  Buckwheat  Maize  Millet  Oats  Rice 
- 357 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Rye  Sorghum  Wheat  Others28 6. TEA, COFFEE, HERBAL INFUSIONS AND COCOA 

 0.05* No GAP 

 (i) Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis)  (ii) Coffee beans  (iii) Herbal infusions (dried)  (a) Flowers  Camomille flowers  Hybiscus flowers  Rose petals  Jasmine flowers  Lime (linden)  Others29  (b) Leaves  Strawberry leaves  Rooibos leaves  Maté  Others30  (c) Roots  Valerian root  Ginseng root  Others31  (d) Other herbal infusions  (iv) Cocoa (fermented beans) 
- 358 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 (v) Carob (st johns bread) 7. HOPS (dried) , including hop pellets and unconcentrated powder 

 20 5.81 GAP EU-N: 0.35 kg as/ha, 14 days PHI 

GAP NAFTA: 0.224 kg as/ha, 7 days PHI. RESIDUE TRIALS EU-N: 1.64; 1.82; 4.02; 4.34 NAFTA: 5.82; 5.81; 4.51 NAFTA data critical. (only 3 trials – ACCEPTABLE IF 

RISK LOW?)Rmax = 11.15 Rber = n/a 

Based on 3 trials only. Proposal by Canada: 10.0 mg/kg; difference between the two proposals based on different calculation-models and/or MRL-classes. 

8. SPICES  (i) Seeds  Anise  Black caraway  Celery seed  Coriander seed  Cumin seed  Dill seed  Fennel seed  Fenugreek  Nutmeg  Others32  (ii) Fruits and berries  Allspice  Anise pepper (Japan pepper)  Caraway  Cardamom  Juniper berries 
- 359 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Pepper, black and white  Vanilla pods  Tamarind  Others33  (iii) Bark  Cinnamon  Others34  (iv) Roots or rhizome  Liquorice  Ginger  Turmeric (Curcuma)  Horse-radish  Others35  (v) Buds  Cloves  Capers  Others36  (vi) Flower stigma  Saffron  Others37  (vii) Aril  Mace  Others38 9. SUGAR PLANTS  Sugar beet (root)  Sugar cane  Chicory roots  Others39 
- 360 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

10. PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS 

 0.02* Not required 0.02 mg/kg was proposed by Canada 

as MRL at LOQ-Level for fat, kidney, muscle and liver. The LOQ of BYI08330-enol calculated and expressed as BYI08330 parent equivalents is 0.01 mg/kg; parent spirotetramat was not found in any livestock tissue. Please, see point B.7.8 for MRL proposal relevant for EU. 

 (i) Meat, preparations of meat, offals, blood, animal fats fresh chilled or frozen, salted, in brine, dried or smoked or processed as flours or meals; other processed products such as sausages and food preparations based on these  (a) Swine  Meat1  Fat free of lean meat  Liver1  Kidney1  Edible offal1  Others40  (b) Bovine  Meat2  Fat1  Liver2  Kidney2  Edible offal2 
- 361 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Others41  (c) Sheep  Meat3  Fat2  Liver3  Kidney3  Edible offal3  Others42  (d) Goat  Meat4  Fat3  Liver4  Kidney4  Edible offal4  Others43  (e) Horses, asses, mules or hinnies  Meat5  Fat4  Liver5  Kidney5  Edible offal5  Others44  (f) Poultry -chicken, geese, duck, turkey and Guinea fowl-, ostrich, pigeon  Meat6  Fat5  Liver6 
- 362 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Kidney6  Edible offal6  Others45  (g) Other farm animals  Meat7  Fat6  Liver7  Kidney7  Edible offal7  Others46  (ii) Milk and cream, not concentrated, nor containing added sugar or sweetening matter, butter and other fats derived from milk, cheese and curd  Cattle  Sheep  Goat  Horse  Others47  (iii) Birds’ eggs, fresh preserved or cooked; Shelled eggs and egg yolks fresh, dried, cooked by steaming or boiling in water, moulded, frozen or otherwise preserved whether or not containing added sugar or sweetening matter 
- 363 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

 Chicken  Duck  Goose  Quail  Others48  (iv) Honey  (v) Amphibians and reptiles  (vi) Snails  (vii) Other terrestrial animal products *Limit of determination. 
- 364 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

APPENDIX 2 - RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) 

(NAFTA only, as EU residue data are listed yet in Annex I.) 

CITRUS 

Residues (ppm) Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC PHI 

(days) BYI 

08330 

BYI 

08330 

cis-enol 

BYI 08330 

cis-ketohydroxy 

BYI 08330 

monohydroxy 

BYI 08330 

enolglucoside 

Total 

BYI08330 

* 

Orange 

fruit 

0 

0 

1 

1 

1 

1 

1 

7 

7 

10 

10 

15 

15 

0.203 

0.199 

0.127 

0.111 

0.104 

0.095 

0.090 

0.097 

0.095 

0.081 

0.073 

0.081 

0.087 

0.077 

0.069 

0.142 

0.137 

0.148 

0.063 

0.075 

0.075 

0.061 

0.061 

0.059 

0.059 

0.063 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.430 

0.418 

0.419 

0.398 

0.402 

0.308 

0.315 

0.322 

0.306 

0.292 

0.282 

0.290 

0.300 

fruit 

without 

peel 

1 

1 

1 

<0.050

<0.050

<0.050

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.250 

0.250 

0.250 

RAFNY008 

FN161-05D 

FN161-05D-A 

USA 

Clermont, 

Florida 

2005 

peel 1 

1 

1 

0.241 

0.218 

0.222 

0.351 

0.323 

0.308 

0.106 

0.100 

0.092 

<0.050 

<0.050 

<0.050 

0.057 

0.050 

0.054 

0.805 

0.741 

0.726 

RAFNY008 

FN161-05D 

FN161-05D-B 

USA 

Clermont, 

Florida 

2005 

Orange 

fruit 

1 

1 

0.057 

0.055 

0.078 

0.079 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.285 

0.284 

RAFNY008 

FN162-05H 

FN162-05H-A 

USA 

Haines City, 

Florida 

2005 

Orange 

fruit 

1 

1 

<0.050

<0.050

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.250 

0.250 

RAFNY008 

FN162-05H 

FN162-05H-B 

USA 

Haines City, 

Florida 

2005 

Orange 

fruit 

1 

1 

<0.050

<0.050

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.250 

0.250 

RAFNY008 

FN163-05H 

FN163-05H-A 

USA 

Oviedo, Florida 

2005 

Orange 

fruit 

1 

1 

0.182 

0.131 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.382 

0.331 
- 365 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues (ppm) Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC PHI 

(days) BYI 

08330 

BYI 

08330 

cis-enol 

BYI 08330 

cis-ketohydroxy 

BYI 08330 

monohydroxy 

BYI 08330 

enolglucoside 

Total 

BYI08330 

* 

RAFNY008 

FN163-05H 

FN163-05H-B 

USA 

Oviedo, Florida 

2005 

Orange 

fruit 

1 

1 

0.094 

0.109 

<0.050 

0.051 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.294 

0.310 

RAFNY008 

FN164-05H 

FN164-05H-A 

USA 

Oviedo, Florida 

2005 

Orange 

fruit 

1 

1 

<0.050

<0.050

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.250 

0.250 

RAFNY008 

FN164-05H 

FN164-05H-B 

USA 

Oviedo, Florida 

2005 

Orange 

fruit 

1 

1 

<0.050

<0.050

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.250 

0.250 

RAFNY008 

FN165-05H 

FN165-05H-A 

USA 

Oviedo, Florida 

2005 

Orange 

fruit 

1 

1 

0.133 

0.151 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.333 

0.351 

RAFNY008 

FN165-05H 

FN165-05H-B 

USA 

Oviedo, Florida 

2005 

Orange 

fruit 

1 

1 

0.103 

0.094 

0.072 

0.076 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.325 

0.320 

RAFNY008 

FN166-05H 

FN166-05H-A 

USA 

Mt Dora, 

Florida 

2005 

Orange 

fruit 

1 

1 

0.117 

0.138 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.317 

0.338 

RAFNY008 

FN166-05H 

FN166-05H-B 

USA 

Mt Dora, 

Florida 

2005 

Orange 

fruit 

1 

1 

0.090 

0.088 

<0.050 

0.052 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.290 

0.290 

RAFNY008 

FN167-05H 

FN167-05H-A 

USA 

Vero Beach, 

Florida 

2005 

Orange 

fruit 

1 

1 

0.207 

0.194 

<0.050 

<0.050 

0.076 

0.077 

<0.050 

<0.050 

<0.050 

<0.050 

0.433 

0.421 
- 366 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues (ppm) Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC PHI 

(days) BYI 

08330 

BYI 

08330 

cis-enol 

BYI 08330 

cis-ketohydroxy 

BYI 08330 

monohydroxy 

BYI 08330 

enolglucoside 

Total 

BYI08330 

* 

RAFNY008 

FN167-05H 

FN167-05H-B 

USA 

Vero Beach, 

Florida 

2005 

Orange 

fruit 

1 

1 

0.119 

0.105 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.319 

0.305 

RAFNY008 

FN168-05H 

FN168-05H-A 

USA 

Vero Beach, 

Florida 

2005 

Orange 

fruit 

1 

1 

0.175 

0.174 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.375 

0.374 

RAFNY008 

FN168-05H 

FN168-05H-B 

USA 

Vero Beach, 

Florida 

2005 

Orange 

fruit 

1 

1 

0.135 

0.156 

0.062 

0.069 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.347 

0.375 

RAFNY008 

FN169-05H 

FN169-05H-A 

USA 

Raymondville, 

Texas 

2005 

Orange 

fruit 

1 

1 

<0.050

<0.050

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.250 

0.250 

RAFNY008 

FN169-05H 

FN169-05H-B 

USA 

Raymondville, 

Texas 

2005 

Orange 

fruit 

1 

1 

<0.050

<0.050

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.250 

0.250 

RAFNY008 

FN170-05H 

FN170-05H-A 

USA 

Fresno, 

California 

2005 

Orange 

fruit 

1 

1 

0.083 

0.119 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.283 

0.319 

RAFNY008 

FN170-05H 

FN170-05H-B 

USA 

Fresno, 

California 

2005 

Orange 

fruit 

1 

1 

<0.050

0.058 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.250 

0.258 

RAFNY008 

FN171-05H 

FN171-05H-A 

USA 

Bakersfield, 

California 

2006 

Orange 

fruit 

1 

1 

0.119 

0.136 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.319 

0.336 
- 367 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues (ppm) Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC PHI 

(days) BYI 

08330 

BYI 

08330 

cis-enol 

BYI 08330 

cis-ketohydroxy 

BYI 08330 

monohydroxy 

BYI 08330 

enolglucoside 

Total 

BYI08330 

* 

RAFNY008 

FN171-05H 

FN171-05H-B 

USA 

Bakersfield, 

California 

2006 

Orange 

fruit 

1 

1 

0.098 

0.093 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.298 

0.293 

RAFNY008 

FN172-05H 

FN172-05H-A 

USA 

Porterville, 

California 

2005 

Orange 

fruit 

1 

1 

<0.050

<0.050

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.250 

0.250 

RAFNY008 

FN172-05H 

FN172-05H-B 

USA 

Porterville, 

California 

2005 

Orange 

fruit 

1 

1 

<0.050

0.053 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

0.250 

0.253 
- 368 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

TREE NUTS 

Residues 

(ppm) Study 

Trial No. 

Trial SubID 

Country 

Year 

Crop 

Portion 

analysed 

PHI 

(days) BYI 

08330 

BYI 

08330 

cisenol 

BYI 08330 

ketohydroxy 

BYI 08330 

monohydroxy 

BYI 

08330 

enolglucoside 

Total 

BYI08330 

calc. * 

Almond 

(Nut 

without 

shell) 

0 

0 

6 

6 

10 

10 

13 

13 

21 

21 

0.014 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.020 

0.025 

0.019 

0.022 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.054 

0.05 

0.05 

0.05 

0.05 

0.05 

0.06 

0.065 

0.059 

0.062 

RAFNY010 

FN202-05H 

FN202-05D-A 

USA 

Fresno, 

California 

2005 

Almond 

(hull)

0 

0 

6 

6 

10 

10 

13 

13 

21 

21 

1.082 

1.394 

1.528 

3.336 

2.737 

2.078 

1.912 

1.480 

1.664 

2.255 

<0.20 

<0.20 

<0.20 

0.579 

0.240 

<0.20 

<0.20 

<0.20 

<0.20 

0.201 

<0.20 

<0.20 

<0.20 

0.429 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

0.407 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

1.882 

2.194 

2.328 

4.951 

3.577 

2.878 

2.712 

2.28 

2.464 

3.056 

Almond 

(Nut 

without 

shell) 

6 

6 

13 

13 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.079 

0.067 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.024 

0.022 

<0.010 

<0.010 

0.012 

<0.010 

0.05 

0.05 

0.135 

0.119 

RAFNY010 

FN202-05H 

FN202-05D-B 

USA 

Fresno, 

California 

2005 

Almond 

(hull)

6 

6 

13 

13 

3.075 

1.540 

3.561 

3.173 

0.546 

<0.20 

0.634 

0.538 

0.436 

<0.20 

0.517 

0.440 

0.312 

<0.20 

0.332 

0.474 

<0.20 

<0.20 

<0.20 

<0.20 

4.569 

2.34 

5.244 

4.825 

Almond 

(Nut 

without 

shell) 

7 

7 

0.036 

0.026 

0.058 

0.045 

<0.010 

<0.010 

0.016 

0.014 

0.018 

<0.010 

0.138 

0.105 

RAFNY010 

FN203-05H 

FN203-05H-A 

USA 

Kerman, 

California 

2005 

Almond 

(hull)

7 

7 

2.885 

2.950 

0.314 

0.347 

<0.20 

<0.20 

0.492 

0.476 

<0.20 

<0.20 

4.091 

4.173 

Almond 

(Nut 

without 

shell) 

7 

7 

0.032 

0.025 

0.059 

0.047 

<0.010 

<0.010 

0.014 

0.012 

0.012 

<0.010 

0.127 

0.104 

RAFNY010 

FN203-05H 

FN203-05H-B 

USA 

Kerman, 

California 

2005 

Almond 

(hull)

7 

7 

1.079 

1.923 

0.295 

0.441 

<0.20 

0.230 

0.528 

0.676 

0.281 

0.372 

2.383 

3.642 

Almond 

(Nut 

without 

shell) 

7 

7 

0.025 

0.024 

0.029 

0.021 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.084 

0.075 

RAFNY010 

FN204-05H 

FN204-05H-A 

USA 

Glenn, 

California 

2005 

Almond 

(hull)

7 

7 

0.603 

0.461 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

1.403 

1.261 
- 369 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues 

(ppm) Study 

Trial No. 

Trial SubID 

Country 

Year 

Crop 

Portion 

analysed 

PHI 

(days) BYI 

08330 

BYI 

08330 

cisenol 

BYI 08330 

ketohydroxy 

BYI 08330 

monohydroxy 

BYI 

08330 

enolglucoside 

Total 

BYI08330 

calc. * 

Almond 

(Nut 

without 

shell) 

7 

7 

0.025 

0.029 

0.028 

0.021 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.083 

0.08 

RAFNY010 

FN204-05H 

FN204-05H-B 

USA 

Glenn, 

California 

2005 

Almond 

(hull)

7 

7 

0.614 

0.634 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

1.414 

1.434 

Almond 

(Nut 

without 

shell) 

7 

7 

0.017 

0.021 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.057 

0.061 

RAFNY010 

FN205-05H 

FN205-05H-A 

USA 

Dinuba, 

California 

2005 

Almond 

(hull)

7 

7 

1.749 

2.827 

<0.20 

0.366 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

2.549 

3.793 

Almond 

(Nut 

without 

shell) 

7 

7 

0.017 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.057 

0.05 

RAFNY010 

FN205-05H 

FN205-05H-B 

USA 

Dinuba, 

California 

2005 

Almond 

(hull)

7 

7 

3.639 

3.376 

0.779 

0.753 

0.327 

0.303 

<0.20 

<0.20 

<0.20 

<0.20 

5.145 

4.832 

Almond 

(Nut 

without 

shell) 

7 

7 

0.011 

0.012 

0.071 

0.051 

0.017 

0.015 

0.025 

0.024 

0.019 

0.010 

0.143 

0.112 

RAFNY010 

FN206-05H 

FN206-05H-A 

USA 

Madera, 

California 

2005 

Almond 

(hull)

7 

7 

1.759 

1.419 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

2.559 

2.219 

Almond 

(Nut 

without 

shell) 

7 

7 

<0.010 

<0.010 

0.035 

0.033 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.075 

0.073 

RAFNY010 

FN206-05H 

FN206-05H-B 

USA 

Madera, 

California 

2005 

Almond 

(hull)

7 

7 

1.197 

0.708 

0.225 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

<0.20 

2.022 

1.508 

Residues 

(ppm) Study 

Trial No. 

Trial SubID 

Country 

Year 

Crop 

Portion 

analysed 

PHI 

(days) BYI 

08330 

BYI 

08330 

cisenol 

BYI 08330 

ketohydroxy 

BYI 08330 

monohydroxy 

BYI 

08330 

enolglucoside 

Total 

BYI08330 

calc. * 

RAFNY010 

FN207-05H 

FN207-05H-A 

USA 

Chula, Georgia 

2005 

Pecan 

nut 

(Nut 

without 

shell) 

7 

7 

0.013 

0.017 

0.012 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.055 

0.057 

RAFNY010 

FN207-05H 

FN207-05H-B 

USA 

Chula, Georgia 

2005 

Pecan 

nut 

 (Nut 

without 

shell)

7 

7 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.05 

0.05 
- 370 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues 

(ppm) Study 

Trial No. 

Trial SubID 

Country 

Year 

Crop 

Portion 

analysed 

PHI 

(days) BYI 

08330 

BYI 

08330 

cisenol 

BYI 08330 

ketohydroxy 

BYI 08330 

monohydroxy 

BYI 

08330 

enolglucoside 

Total 

BYI08330 

calc. * 

RAFNY010 

FN208-05H 

FN208-05H-A 

USA 

Nashville, 

Georgia 

2005 

Pecan 

nut 

(Nut 

without 

shell) 

7 

7 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.05 

0.05 

RAFNY010 

FN208-05H 

FN208-05H-B 

USA 

Nashville, 

Georgia 

2005 

Pecan 

nut 

 (Nut 

without 

shell)

7 

7 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.05 

0.05 

RAFNY010 

FN209-05H 

FN209-05H-A 

USA 

Proctor, 

Arkansas 

2005 

Pecan 

nut 

(Nut 

without 

shell) 

0 

0 

7 

7 

10 

10 

14 

14 

21 

21 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.05 

0.05 

0.05 

0.05 

0.05 

0.05 

0.05 

0.05 

0.05 

0.05 

RAFNY010 

FN209-05H 

FN209-05H-B 

USA 

Proctor, 

Arkansas 

2005 

Pecan 

nut 

 (Nut 

without 

shell)

7 

7 

14 

14 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.05 

0.05 

0.05 

0.05 

RAFNY010 

FN210-05H 

FN210-05H-A 

USA 

Wharton, 

Texas 

2005 

Pecan 

nut 

(Nut 

without 

shell) 

7 

7 

<0.010 

<0.010 

0.035 

0.032 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.075 

0.072 

RAFNY010 

FN210-05H 

FN210-05H-B 

USA 

Wharton, 

Texas 

2005 

Pecan 

nut 

 (Nut 

without 

shell)

7 

7 

<0.010 

<0.010 

0.122 

0.113 

<0.010 

<0.010 

<0.010 

0.011 

<0.010 

<0.010 

0.162 

0.154 

RAFNY010 

FN211-05H 

FN211-05H-A 

USA 

D'Hanis, Texas 

2005 

Pecan 

nut 

(Nut 

without 

shell) 

7 

7 

<0.010 

<0.010 

0.132 

0.189 

<0.010 

0.017 

0.015 

0.027 

<0.010 

<0.010 

0.177 

0.253 
- 371 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues 

(ppm) Study 

Trial No. 

Trial SubID 

Country 

Year 

Crop 

Portion 

analysed 

PHI 

(days) BYI 

08330 

BYI 

08330 

cisenol 

BYI 08330 

ketohydroxy 

BYI 08330 

monohydroxy 

BYI 

08330 

enolglucoside 

Total 

BYI08330 

calc. * 

RAFNY010 

FN211-05H 

FN211-05H-B 

USA 

D'Hanis, Texas 

2005 

Pecan 

nut 

 (Nut 

without 

shell)

7 

7 

<0.010 

<0.010 

0.232 

0.237 

0.014 

0.010 

0.031 

0.027 

<0.010 

<0.010 

0.297 

0.294 
- 372 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

POME FRUIT 

Residues 

(ppm) 

Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC PHI 

(days) 

BYI08330 BYI08330-

enol 

BYI08330-

ketohydroxy 

BYI08330-

monohydroxy 

BYI08330-

enolglucoside 

Total 

BYI08330 

* 

RAFNY009 

FN184-05H 

FN184-05H-A 

USA 

North Rose, 

New York 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.012 

0.016 

0.032 

0.021 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.014 

0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.052 

0.056 

0.076 

0.061 

RAFNY009 

FN184-05H 

FN184-05H-B 

USA 

North Rose, 

New York 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.021 

0.021 

0.022 

0.022 

0.011 

0.012 

0.013 

0.013 

0.016 

0.020 

0.026 

0.022 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.068 

0.073 

0.081 

0.077 

RAFNY009 

FN185-05H 

FN185-05H-A 

USA 

Hereford, 

Pennsylvania 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.084 

0.114 

0.078 

0.095 

0.012 

0.017 

0.016 

0.016 

0.016 

0.020 

0.021 

0.022 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.132 

0.171 

0.135 

0.153 

RAFNY009 

FN185-05H 

FN185-05H-B 

USA 

Hereford, 

Pennsylvania 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.070 

0.064 

0.040 

0.044 

0.018 

0.019 

0.013 

0.013 

0.026 

0.024 

0.022 

0.023 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.134 

0.127 

0.095 

0.1 

RAFNY009 

FN186-05H 

FN186-05H-A 

USA 

Batesville, 

Virginia 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.049 

0.051 

0.034 

0.021 

0.020 

0.021 

0.015 

<0.010 

0.018 

0.033 

0.011 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.107 

0.125 

0.08 

0.061 

RAFNY009 

FN186-05H 

FN186-05H-B 

USA 

Batesville, 

Virginia 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.034 

0.027 

0.020 

0.027 

0.012 

<0.010 

<0.010 

0.012 

0.065 

0.082 

0.056 

0.055 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.131 

0.139 

0.106 

0.114 

RAFNY009 

FN187-05H 

FN187-05H-A 

USA 

Blairsville, 

Georgia 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.054 

0.056 

0.022 

0.020 

0.017 

0.016 

<0.010 

<0.010 

0.017 

0.020 

0.016 

0.014 

0.012 

0.012 

0.011 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.11 

0.114 

0.069 

0.064 
- 373 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues 

(ppm) 

Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC PHI 

(days) 

BYI08330 BYI08330-

enol 

BYI08330-

ketohydroxy 

BYI08330-

monohydroxy 

BYI08330-

enolglucoside 

Total 

BYI08330 

* 

RAFNY009 

FN187-05H 

FN187-05H-B 

USA 

Blairsville, 

Georgia 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.044 

0.039 

0.018 

0.019 

0.023 

0.022 

0.016 

0.017 

0.029 

0.028 

0.029 

0.025 

0.020 

0.022 

0.021 

0.023 

<0.010 

<0.010 

<0.010 

<0.010 

0.126 

0.121 

0.094 

0.094 

RAFNY009 

FN188-05HA 

FN188-05HAA 

USA 

Conklin, 

Michigan 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.041 

0.031 

0.031 

0.023 

<0.010 

<0.010 

<0.010 

<0.010 

0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.081 

0.071 

0.071 

0.063 

RAFNY009 

FN188-05HA 

FN188-05HAB 

USA 

Conklin, 

Michigan 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.022 

0.025 

0.018 

0.018 

0.011 

<0.010 

<0.010 

0.011 

<0.010 

<0.010 

0.013 

0.017 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.063 

0.065 

0.061 

0.066 

RAFNY009 

FN189-05H 

FN189-05H-A 

Canada 

Simcoe, 

Ontario 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.012 

0.016 

0.016 

0.018 

0.014 

0.014 

0.018 

0.019 

<0.010 

<0.010 

0.011 

0.013 

<0.010 

<0.010 

<0.010 

0.011 

<0.010 

<0.010 

<0.010 

<0.010 

0.056 

0.06 

0.065 

0.071 

RAFNY009 

FN189-05H 

FN189-05H-B 

Canada 

Simcoe, 

Ontario 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.014 

0.015 

0.011 

<0.010 

0.022 

0.023 

0.017 

0.019 

0.017 

0.013 

0.012 

0.012 

0.011 

0.012 

0.012 

0.012 

<0.010 

<0.010 

<0.010 

<0.010 

0.074 

0.073 

0.062 

0.063 

RAFNY009 

FN190-05H 

FN190-05H-A 

USA, Perry, 

Utah 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.081 

0.088 

0.066 

0.061 

0.039 

0.034 

0.042 

0.039 

0.017 

0.012 

0.020 

0.025 

0.022 

0.017 

0.018 

0.021 

<0.010 

<0.010 

<0.010 

<0.010 

0.169 

0.161 

0.156 

0.156 

RAFNY009 

FN190-05H 

FN190-05H-B 

USA 

Perry, Utah 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.108 

0.085 

0.066 

0.059 

0.093 

0.078 

0.096 

0.078 

0.095 

0.068 

0.093 

0.081 

0.069 

0.063 

0.067 

0.062 

<0.010 

<0.010 

<0.010 

<0.010 

0.375 

0.304 

0.332 

0.29 

RAFNY009 

FN191-05H 

FN191-05H-A 

USA 

Fresno, 

California 

2005 

Apple 

fruit 

7 

7 

13 

13 

0.276 

0.316 

0.221 

0.230 

0.010 

0.016 

<0.010 

<0.010 

<0.010 

0.011 

<0.010 

<0.010 

0.014 

0.016 

0.019 

0.012 

<0.010 

<0.010 

<0.010 

<0.010 

0.32 

0.369 

0.27 

0.272 
- 374 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues 

(ppm) 

Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC PHI 

(days) 

BYI08330 BYI08330-

enol 

BYI08330-

ketohydroxy 

BYI08330-

monohydroxy 

BYI08330-

enolglucoside 

Total 

BYI08330 

* 

RAFNY009 

FN192-05H 

FN192-05H-A 

USA 

Payette, Idaho 

2005 

Apple 

fruit 

0 

0 

7 

7 

9 

9 

14 

14 

21 

21 

0.206 

0.287 

0.218 

0.236 

0.228 

0.417 

0.103 

0.102 

0.104 

0.078 

0.055 

0.055 

0.053 

0.057 

0.073 

0.075 

0.057 

0.055 

0.056 

0.040 

0.017 

0.023 

0.024 

0.030 

0.039 

0.042 

0.032 

0.026 

0.039 

0.027 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.298 

0.385 

0.315 

0.343 

0.36 

0.554 

0.212 

0.203 

0.219 

0.165 

RAFNY009 

FN192-05H 

FN192-05H-B 

USA 

Payette, Idaho 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.104 

0.097 

0.052 

0.062 

0.086 

0.086 

0.089 

0.093 

0.044 

0.045 

0.051 

0.055 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.254 

0.248 

0.212 

0.23 

RAFNY009 

FN193-05H 

FN193-05H-A 

USA 

Parkdale, 

Oregon 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.026 

0.027 

0.015 

0.022 

0.028 

0.028 

0.020 

0.022 

0.019 

0.018 

0.025 

0.024 

0.011 

<0.010 

<0.010 

0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.094 

0.093 

0.08 

0.088 

RAFNY009 

FN193-05H 

FN193-05H-B 

USA, 

Parkdale, 

Oregon; 2005 

Apple 

fruit 

7 

7 

14 

14 

0.029 

0.030 

0.026 

0.024 

0.073 

0.064 

0.055 

0.054 

0.046 

0.042 

0.041 

0.041 

0.025 

0.024 

0.023 

0.021 

<0.010 

<0.010 

<0.010 

<0.010 

0.183 

0.17 

0.155 

0.15 

RAFNY009 

FN194-05H 

FN194-05H-A 

USA 

Ephrata, 

Washington 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.095 

0.111 

0.095 

0.077 

0.030 

0.031 

0.034 

0.029 

0.016 

0.017 

0.023 

0.020 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.161 

0.179 

0.172 

0.146 

RAFNY009 

FN194-05H 

FN194-05H-B 

USA 

Ephrata, 

Washington; 

2005 

Apple 

fruit 

7 

7 

14 

14 

0.039 

0.052 

0.026 

0.033 

0.035 

0.037 

0.027 

0.030 

0.022 

0.024 

0.024 

0.022 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.116 

0.133 

0.097 

0.105 

RAFNY009 

FN195-05H 

FN195-05H-B 

USA 

Hood River, 

Oregon; 2005 

Apple 

fruit 

7 

7 

14 

14 

0.057 

0.038 

0.031 

0.029 

0.023 

0.014 

0.023 

0.018 

0.015 

0.011 

0.017 

0.015 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.115 

0.083 

0.091 

0.082 
- 375 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues 

(ppm) 

Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC PHI 

(days) BYI08330 BYI08330-

enol 

BYI08330-

ketohydroxy 

BYI08330-

monohydroxy 

BYI08330-

enolglucoside 

Total 

BYI08330 

* 

RAFNY009 

FN196-05H 

FN196-05H-A 

USA 

Orefield, 

Pennsylvania 

2005 

Pear 

fruit 

7 

7 

14 

14 

0.019 

0.022 

0.034 

0.030 

<0.010 

<0.010 

<0.010 

<0.010 

0.024 

0.028 

0.029 

0.036 

0.017 

0.019 

0.017 

0.017 

<0.010 

<0.010 

<0.010 

<0.010 

0.08 

0.089 

0.1 

0.103 

RAFNY009 

FN196-05H 

FN196-05H-B 

USA 

Orefield, 

Pennsylvania 

2005 

Pear 

fruit 

7 

7 

14 

14 

0.041 

0.037 

0.065 

0.073 

<0.010 

<0.010 

<0.010 

0.011 

0.037 

0.036 

0.040 

0.047 

0.022 

0.022 

0.020 

0.020 

<0.010 

<0.010 

<0.010 

<0.010 

0.12 

0.115 

0.145 

0.161 

RAFNY009 

FN197-05H 

FN197-05H-A 

USA 

Madera, 

California 

2005 

Pear 

fruit 

0 

0 

7 

7 

10 

10 

14 

14 

21 

21 

0.177 

0.151 

0.142 

0.088 

0.099 

0.095 

0.060 

0.093 

0.074 

0.101 

0.171 

0.127 

0.148 

0.119 

0.147 

0.167 

0.127 

0.145 

0.097 

0.114 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.015 

0.012 

0.018 

0.012 

0.020 

0.022 

0.023 

0.023 

0.027 

0.027 

0.383 

0.31 

0.328 

0.239 

0.286 

0.304 

0.23 

0.281 

0.218 

0.262 

RAFNY009 

FN197-05H 

FN197-05H-B 

USA 

Madera, 

California 

2005 

Pear 

fruit 

7 

7 

14 

14 

0.098 

0.121 

0.084 

0.079 

0.170 

0.195 

0.148 

0.137 

0.012 

0.016 

0.013 

0.013 

<0.010 

<0.010 

<0.010 

<0.010 

0.026 

0.031 

0.031 

0.030 

0.316 

0.373 

0.286 

0.269 

RAFNY009 

FN198-05H 

FN198-05H-A 

USA 

Marysville, 

California 

2005 

Pear 

fruit 

7 

7 

14 

14 

0.108 

0.164 

0.114 

0.101 

<0.010 

<0.010 

<0.010 

<0.010 

0.015 

0.020 

0.015 

0.014 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.153 

0.214 

0.159 

0.145 

RAFNY009 

FN198-05H 

FN198-05H-B 

USA 

Marysville, 

California 

2005 

Pear 

fruit 

7 

7 

14 

14 

0.083 

0.098 

0.072 

0.087 

<0.010 

<0.010 

<0.010 

<0.010 

0.016 

0.017 

0.013 

0.015 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.129 

0.145 

0.115 

0.132 

RAFNY009 

FN199-05H 

FN199-05H-B 

USA 

Ephrata, 

Washington 

2005 

Pear 

fruit 

7 

7 

14 

14 

0.100 

0.114 

0.052 

0.082 

<0.010 

<0.010 

<0.010 

<0.010 

0.025 

0.025 

0.014 

0.018 

0.058 

0.059 

0.043 

0.050 

<0.010 

<0.010 

<0.010 

<0.010 

0.203 

0.218 

0.129 

0.17 
- 376 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues 

(ppm) 

Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC PHI 

(days) BYI08330 BYI08330-

enol 

BYI08330-

ketohydroxy 

BYI08330-

monohydroxy 

BYI08330-

enolglucoside 

Total 

BYI08330 

* 

RAFNY009 

FN200-05H 

FN200-05H-A 

USA 

Parkdale, 

Oregon 

2005 

Pear 

fruit 

7 

7 

14 

14 

0.146 

0.143 

0.124 

0.124 

<0.010 

<0.010 

<0.010 

<0.010 

0.029 

0.024 

0.016 

0.023 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.205 

0.197 

0.17 

0.177 

RAFNY009 

FN200-05H 

FN200-05H-B 

USA 

Parkdale, 

Oregon 

2005 

Pear 

fruit 

7 

7 

14 

14 

0.117 

0.127 

0.153 

0.087 

<0.010 

<0.010 

<0.010 

<0.010 

0.064 

0.057 

0.052 

0.050 

0.012 

0.013 

0.016 

0.013 

<0.010 

<0.010 

<0.010 

<0.010 

0.213 

0.217 

0.241 

0.17 

RAFNY009 

FN201-05H 

FN201-05H-A 

USA 

Hood River, 

Oregon; 2005 

Pear 

fruit 

7 

7 

14 

14 

0.065 

0.056 

0.065 

0.042 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.012 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.105 

0.098 

0.105 

0.082 

RAFNY009 

FN201-05H 

FN201-05H-B 

USA 

Hood River, 

Oregon; 2005 

Pear 

fruit 

7 

7 

14 

14 

0.022 

0.021 

0.022 

0.014 

<0.010 

<0.010 

<0.010 

<0.010 

0.010 

<0.010 

<0.010 

<0.010 

0.011 

0.015 

0.011 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.063 

0.066 

0.063 

0.054 
- 377 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

STONE FRUIT 

Study Residues (ppm) 

Trial No. 

Trial SubID 

Country 

Year 

Crop 

Portion 

analysed 

DALTa

(days) BYI 

08330 

BYI 

08330 

cisenol 

BYI 08330 

cis-ketohydroxy 

BYI 

08330 

monohydroxy 

BYI 

08330 

enolglucoside 

Total 

BYI08330 

* 

RAFNY001 

FN146-05H 

FN146-05H-A 

USA 

East Williamson, 

New York 

2005 

Peach, fruit 

Cresthaven 

7 

7 

14 

14 

0.099 

0.239 

0.091 

0.078 

0.163 

0.237 

0.158 

0.145 

<0.010 

0.012 

0.013 

<0.010 

0.022 

0.034 

0.048 

0.028 

<0.020 

0.028 

0.038 

0.027 

0.314 

0.55 

0.348 

0.288 

RAFNY001 

FN146-05H 

FN146-05H-A 

USA 

East Williamson, 

New York 

2005 

Peach, fruit 

Cresthaven 

7 

7 

14 

14 

0.042 

0.047 

0.064 

0.024 

0.554 

0.431 

0.539 

0.394 

0.028 

0.015 

0.017 

0.019 

0.056 

0.053 

0.032 

0.086 

0.020 

<0.020 

<0.020 

0.041 

0.7 

0.566 

0.672 

0.564 

RAFNY001 

FN147-05D 

FN147-05D-A 

USA 

Chula, Georgia 

2005 

Peach, fruit 

Hawthorne 

7 

7 

14 

14 

0.019 

0.014 

0.018 

0.043 

0.372 

0.473 

0.217 

0.323 

0.013 

<0.010 

<0.010 

0.014 

0.086 

0.045 

0.047 

0.059 

<0.020 

<0.020 

0.024 

0.037 

0.51 

0.562 

0.316 

0.476 

RAFNY001 

FN147-05D 

FN147-05D-A 

USA 

Chula, Georgia 

2005 

Peach, fruit 

Hawthorne 

7 

7 

14 

14 

0.012 

<0.010 

<0.010 

<0.010 

0.320 

0.261 

0.122 

0.212 

0.015 

<0.010 

<0.010 

0.011 

0.054 

0.035 

0.032 

0.056 

0.021 

<0.020 

0.025 

0.030 

0.422 

0.336 

0.199 

0.319 

RAFNY001 

FN148-05H 

FN148-05H-A 

USA 

Plains, Georgia 

2005 

Peach, fruit 

Redskin 10 

7 

7 

14 

14 

<0.010 

0.013 

<0.010 

<0.010 

0.187 

0.184 

0.103 

0.106 

<0.010 

<0.010 

<0.010 

<0.010 

0.048 

0.041 

0.056 

0.045 

0.047 

0.031 

0.036 

0.027 

0.302 

0.279 

0.215 

0.198 

RAFNY001 

FN148-05H 

FN148-05H-B 

USA 

Plains, Georgia 

2005 

Peach, fruit 

Redskin 10 

7 

7 

14 

14 

<0.010 

0.013 

<0.010 

<0.010 

0.375 

0.362 

0.230 

0.192 

<0.010 

0.011 

<0.010 

<0.010 

0.065 

0.075 

0.082 

0.080 

0.048 

0.066 

0.044 

0.036 

0.508 

0.527 

0.376 

0.328 

RAFNY001 

FN149-05H 

FN149-05H-A 

USA 

Goldsboro, North 

Carolina 

2005 

Peach, fruit 

Norman 

7 

7 

14 

14 

0.029 

0.022 

0.011 

<0.010 

0.385 

0.242 

0.108 

0.137 

0.015 

0.012 

<0.010 

<0.010 

0.083 

0.053 

0.052 

0.057 

0.033 

<0.020 

<0.020 

0.030 

0.545 

0.349 

0.201 

0.244 

RAFNY001 

FN149-05H 

FN149-05H-B 

USA 

Goldsboro, North 

Carolina 

2005 

Peach, fruit 

Norman 

7 

7 

14 

14 

0.028 

0.045 

0.014 

0.014 

0.499 

0.507 

0.145 

0.186 

0.022 

0.034 

0.013 

<0.010 

0.122 

0.155 

0.106 

0.150 

0.049 

0.080 

0.048 

0.060 

0.72 

0.821 

0.326 

0.42 
- 378 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Study Residues (ppm) 

Trial No. 

Trial SubID 

Country 

Year 

Crop 

Portion 

analysed 

DALTa

(days) BYI 

08330 

BYI 

08330 

cisenol 

BYI 08330 

cis-ketohydroxy 

BYI 

08330 

monohydroxy 

BYI 

08330 

enolglucoside 

Total 

BYI08330 

* 

RAFNY001 

FN150-05D 

FN150-05D-A 

USA 

Beamsville, Ontario 

2005 

Peach, fruit 

Canadian 

Harmony 

7 

7 

14 

14 

0.010 

0.013 

<0.010 

<0.010 

0.327 

0.310 

0.116 

0.268 

<0.010 

<0.010 

<0.010 

<0.010 

0.016 

0.027 

<0.010 

0.028 

0.040 

0.053 

0.030 

0.049 

0.403 

0.413 

0.176 

0.365 

RAFNY001 

FN150-05D 

FN150-05D-B 

USA 

Beamsville, Ontario 

2005 

Peach, fruit 

Canadian 

Harmony 

7 

7 

14 

14 

<0.010 

<0.010 

<0.010 

<0.010 

0.305 

0.521 

0.277 

0.086 

0.016 

0.025 

0.015 

<0.010 

0.046 

0.093 

0.040 

<0.010 

0.037 

0.041 

0.039 

0.049 

0.414 

0.69 

0.381 

0.165 

RAFNY001 

FN151-05H 

FN151-05H-A 

USA 

Waller, Texas 

2005 

Peach, fruit 

Texas 

Royal 

7 

7 

14 

14 

0.047 

0.056 

0.026 

0.023 

0.628 

0.942 

0.338 

0.396 

0.017 

0.022 

0.013 

0.015 

0.108 

0.164 

0.152 

0.171 

0.041 

0.043 

0.049 

0.045 

0.841 

1.227 

0.578 

0.65 

RAFNY001 

FN151-05H 

FN151-05H-B 

USA 

Waller, Texas 

2005 

Peach, fruit 

Texas 

Royal 

7 

7 

14 

14 

0.056 

0.038 

0.014 

0.019 

0.742 

0.841 

0.487 

0.425 

0.032 

0.025 

0.016 

0.020 

0.160 

0.168 

0.198 

0.214 

0.085 

0.070 

0.055 

0.056 

1.075 

1.142 

0.77 

0.734 

RAFNY001 

FN152-05H 

FN152-05H-B 

USA 

Fresno, California 

2005 

Peach, fruit 

OHenry 

7 

7 

14 

14 

0.044 

0.077 

0.043 

0.048 

0.362 

0.503 

0.419 

0.324 

<0.010 

0.010 

<0.010 

<0.010 

0.053 

0.077 

0.082 

0.092 

0.021 

0.026 

0.019 

0.025 

0.49 

0.693 

0.573 

0.499 

RAFNY001 

FN153-05H 

FN153-05H-A 

USA 

Selma, California 

2005 

Peach, fruit 

Ryan Sun 

7 

7 

14 

14 

0.161 

0.113 

0.068 

0.164 

0.280 

0.229 

0.088 

0.137 

<0.010 

<0.010 

<0.010 

<0.010 

0.057 

0.054 

0.034 

0.043 

0.026 

<0.020 

<0.020 

<0.020 

0.534 

0.426 

0.22 

0.374 

RAFNY001 

FN153-05H 

FN153-05H-B 

USA 

Selma, California 

2005 

Peach, fruit 

Ryan Sun 

7 

7 

14 

14 

0.052 

0.069 

0.035 

0.047 

0.366 

0.516 

0.292 

0.229 

<0.010 

0.010 

<0.010 

<0.010 

0.101 

0.131 

0.119 

0.117 

0.028 

0.040 

<0.020 

0.021 

0.557 

0.766 

0.476 

0.424 

RAFNY001 

FN154-05H 

FN154-05H-A 

USA 

Live Oak, California 

2005 

Peach, fruit 

Halfords 

7 

7 

14 

14 

0.108 

0.123 

0.076 

0.071 

0.194 

0.240 

0.098 

0.108 

<0.010 

<0.010 

<0.010 

<0.010 

0.037 

0.044 

0.031 

0.036 

<0.020 

<0.020 

<0.020 

<0.020 

0.369 

0.437 

0.235 

0.245 

RAFNY001 

FN154-05H 

FN154-05H-B 

USA 

Live Oak, California 

2005 

Peach, fruit 

Halfords 

7 

7 

14 

14 

0.091 

0.093 

0.096 

0.059 

0.350 

0.586 

0.369 

0.273 

<0.010 

<0.010 

0.012 

0.011 

0.038 

0.064 

0.073 

0.077 

<0.020 

<0.020 

0.021 

0.023 

0.509 

0.773 

0.571 

0.443 
- 379 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Study Residues (ppm) 

Trial No. 

Trial SubID 

Country 

Year 

Crop 

Portion 

analysed 

DALTa

(days) BYI 

08330 

BYI 

08330 

cisenol 

BYI 08330 

cis-ketohydroxy 

BYI 

08330 

monohydroxy 

BYI 

08330 

enolglucoside 

Total 

BYI08330 

* 

RAFNY001 

FN152-05D 

FN152-05H-B 

USA 

Fresno, California 

2005 

Peach, fruit 

OHenry 

0 

0 

7 

7 

7 

7 

10 

10 

14 

14 

14 

14 

21 

21 

0.101 

0.083 

0.044 

0.077 

0.024 

0.034 

0.002 

0.002 

0.043 

0.048 

0.052 

0.051 

0.044 

0.054 

0.222 

0.231 

0.362 

0.503 

0.237 

0.178 

0.003 

0.003 

0.419 

0.324 

0.184 

0.248 

0.170 

0.134 

0.007 

0.005 

0.006 

0.010 

0.005 

0.002 

0.002 

0.002 

0.007 

0.002 

0.002 

0.002 

0.005 

0.002 

0.060 

0.071 

0.053 

0.077 

0.062 

0.051 

0.003 

0.003 

0.082 

0.092 

0.049 

0.105 

0.126 

0.067 

0.018 

0.022 

0.021 

0.026 

0.048 

0.008 

0.008 

0.008 

0.020 

0.025 

0.025 

0.025 

0.017 

0.015 

0.408 

0.412 

0.486 

0.693 

0.376 

0.273 

0.018 

0.018 

0.571 

0.491 

0.312 

0.431 

0.362 

0.272 

PLUM 

Residues 

Study (ppm) 

Trial No. 

Trial SubID 

Country 

Year 

Crop 

Portion 

analysed 

DALTa

(days) BYI 

08330 

BYI 

08330 

cisenol 

BYI 

08330 

cis-ketohydroxy 

BYI 

08330 

monohydroxy 

BYI 

08330 

enolglucosid

e 

Total 

BYI08330 

* 

RAFNY001 

FN155-05H 

FN155-05H-A 

USA 

Conklin, Michigan 

2005 

Plum, fruit 

Stanley 

7 

7 

14 

14 

<0.01

0 

<0.01

0 

0.047

0.076 

0.116 

0.248 

0.260 

0.169 

<0.010 

<0.010 

<0.010 

<0.010 

0.048 

0.057 

0.099 

0.069 

0.019 

0.023 

0.041 

0.029 

0.203 

0.348 

0.457 

0.353 

RAFNY001 

FN155-05H 

FN155-05H-B 

USA 

Conklin, Michigan 

2005 

Plum, fruit 

Stanley 

7 

7 

14 

14 

<0.01

0 

<0.01

0 

0.030

0.035 

0.582 

0.349 

0.466 

0.382 

0.021 

0.019 

0.019 

0.017 

0.164 

0.103 

0.193 

0.143 

0.065 

0.042 

0.067 

0.058 

0.842 

0.523 

0.775 

0.635 

RAFNY001 

FN156-05D 

FN156-05D-A 

USA 

Selma, California 

2005 

Plum, fruit 

September 

Sun 

0 

0 

7 

7 

10 

10 

14 

14 

21 

21 

0.017

0.036

0.027

0.038

<0.01

0 

0.022

<0.01

0 

<0.01

0 

0.015

0.014 

0.058 

0.111 

0.290 

0.145 

0.079 

0.294 

0.073 

0.090 

0.047 

0.073 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.011 

0.036 

0.015 

0.017 

0.071 

0.021 

0.018 

0.025 

0.040 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.105 

0.178 

0.373 

0.218 

0.126 

0.407 

0.124 

0.138 

0.107 

0.147 

RAFNY001 

FN156-05D 

FN156-05D-B 

USA 

Selma, California 

2005 

Plum, fruit 

September 

Sun 

7 

7 

14 

14 

<0.01

0 

<0.01

0 

<0.01

0 

<0.01

0 

0.211 

0.189 

0.144 

0.092 

<0.010 

<0.010 

<0.010 

<0.010 

0.037 

0.036 

0.067 

0.036 

<0.010 

<0.010 

<0.010 

<0.010 

0.278 

0.255 

0.241 

0.158 
- 380 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues 

Study (ppm) 

Trial No. 

Trial SubID 

Country 

Year 

Crop 

Portion 

analysed 

DALTa

(days) BYI 

08330 

BYI 

08330 

cisenol 

BYI 

08330 

cis-ketohydroxy 

BYI 

08330 

monohydroxy 

BYI 

08330 

enolglucosid

e 

Total 

BYI08330 

* 

RAFNY001 

FN157-05H 

FN157-05H-A 

USA 

Orlando, California 

2005 

Plum, fruit 

French 

Prune 

7 

7 

14 

14 

0.029

0.040

0.037

0.044 

0.068 

0.090 

0.098 

0.111 

<0.010 

<0.010 

<0.010 

<0.010 

0.076 

0.082 

0.127 

0.185 

<0.010 

<0.010 

0.012 

0.011 

0.193 

0.232 

0.284 

0.361 

RAFNY001 

FN157-05H 

FN157-05H-B 

USA 

Orlando, California 

2005 

Plum, fruit 

French 

Prune 

7 

7 

14 

14 

0.026

0.029

0.029

0.030 

0.046 

0.046 

0.062 

0.076 

<0.010 

<0.010 

<0.010 

<0.010 

0.062 

0.074 

0.120 

0.113 

<0.010 

<0.010 

<0.010 

<0.010 

0.154 

0.169 

0.231 

0.239 

RAFNY001 

FN158-05H 

FN158-05H-A 

USA 

Sanger, California 

2005 

Plum, fruit 

Catalina 

7 

7 

14 

14 

<0.01

0 

<0.01

0 

<0.01

0 

<0.01

0 

0.254 

0.197 

0.253 

0.153 

<0.010 

<0.010 

<0.010 

<0.010 

0.057 

0.029 

0.118 

0.072 

0.021 

0.013 

0.073 

0.037 

0.352 

0.259 

0.464 

0.282 

RAFNY001 

FN158-05H 

FN158-05H-B 

USA 

Sanger, California 

2005 

Plum, fruit 

Catalina 

7 

7 

14 

14 

<0.01

0 

<0.01

0 

<0.01

0 

<0.01

0 

0.073 

0.086 

0.057 

0.039 

<0.010 

<0.010 

<0.010 

<0.010 

0.014 

0.015 

0.019 

0.013 

<0.010 

<0.010 

0.010 

<0.010 

0.117 

0.131 

0.106 

0.082 

RAFNY001 

FN159-05H 

FN159-05H-A 

USA 

Reedley, California 

2005 

Plum, fruit 

92503 

Golden 

Baby 

0 

0 

7 

7 

0.010

<0.01

0 

<0.01

0 

<0.01

0 

0.019 

0.023 

0.013 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.059 

0.063 

0.053 

0.05 

RAFNY001 

FN159-05H 

FN159-05H-B 

USA 

Reedley, California 

2005 

Plum, fruit 

92503 

Golden 

Baby 

7 

7 

14 

14 

<0.01

0 

<0.01

0 

<0.01

0 

<0.01

0 

0.056 

0.048 

0.036 

0.020 

<0.010 

<0.010 

<0.010 

<0.010 

0.020 

0.013 

0.031 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.106 

0.091 

0.097 

0.06 

RAFNY001 

FN160-05H 

FN160-05H-A 

USA 

Forest Grove, Oregon 

2005 

Plum, fruit 

Mory 

7 

7 

14 

14 

0.028

0.018

0.023

0.032 

0.169 

0.081 

0.162 

0.136 

<0.010 

<0.010 

<0.010 

<0.010 

0.132 

0.067 

0.148 

0.175 

0.015 

<0.010 

0.015 

0.016 

0.354 

0.186 

0.358 

0.369 

RAFNY001 

FN160-05H 

FN160-05H-B 

USA 

Forest Grove, Oregon 

2005 

Plum, fruit 

Mory 

7 

7 

14 

14 

0.021

0.024

0.021

<0.01

0 

0.315 

0.277 

0.311 

0.120 

<0.010 

<0.010 

0.011 

<0.010 

0.200 

0.190 

0.343 

0.146 

0.024 

0.024 

0.041 

0.021 

0.57 

0.525 

0.727 

0.307 
- 381 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

CHERRY 

Study Residues (ppm) 

Trial No. 

Trial SubID 

GLP 

Year 

Crop 

Variety 

PHI 

(days) BYI 

08330 

BYI 08330 

cis-enol 

BYI 

08330 

cis-ketohydroxy 

BYI 

08330 

monohydroxy 

BYI 

08330 

enolglucoside 

Total 

BYI08330 

calc. * 

RAFNY001 

FN140-05H 

FN140-05H-A 

GLP yes 

2005 

Cherry, 

sour 

Mont 

Morency 

7 

7 

14 

14 

0.056 

0.075 

<0.010 

<0.010 

1.026 

0.876 

0.682 

0.455 

0.036 

0.045 

0.049 

0.085 

0.219 

0.301 

0.275 

0.487 

0.271 

0.204 

0.345 

0.401 

1.608 

1.501 

1.361 

1.438 

RAFNY001 

FN140-05H 

FN140-05H-B 

GLP yes 

2005 

Cherry, 

sour 

Mont 

Morency 

7 

7 

14 

14 

0.017 

<0.010 

<0.010 

<0.010 

1.32 

1.08 

0.780 

0.678 

0.086 

0.051 

0.055 

0.074 

0.402 

0.227 

0.340 

0.370 

0.302 

0.253 

0.337 

0.359 

2.127 

1.621 

1.522 

1.491 

RAFNY001 

FN141-05H 

FN141-05H-A 

GLP yes 

2005 

Cherry, 

sour 

Mont 

Morency 

7 

7 

14 

14 

0.043 

0.060 

0.031 

0.015 

1.28 

1.29 

0.861 

0.03 

0.044 

0.055 

0.045 

0.053 

0.102 

0.115 

0.154 

0.174 

0.092 

0.106 

0.120 

0.115 

1.561 

1.626 

1.211 

0.387 

RAFNY001 

FN141-05H 

FN141-05H-B 

GLP yes 

2005 

Cherry, 

sour 

Mont 

Morency 

7 

7 

14 

14 

0.015 

0.011 

<0.010 

0.010 

1.13 

1.08 

0.573 

0.659 

0.053 

0.060 

0.053 

0.091 

0.117 

0.127 

0.194 

0.272 

0.100 

0.085 

0.137 

0.211 

1.415 

1.363 

0.967 

1.243 

RAFNY001 

FN142-05H 

FN142-05H-A 

GLP yes 

2005 

Cherry, 

sour 

Mont 

Morency 

7 

7 

14 

14 

0.016 

0.022 

0.011 

0.027 

1.38 

1.61 

1.38 

1.50 

0.062 

0.065 

0.065 

0.073 

0.223 

0.218 

0.201 

0.265 

0.231 

0.205 

0.275 

0.321 

1.912 

2.12 

1.932 

2.186 

RAFNY001 

FN142-05H 

FN142-05H-B 

GLP yes 

2005 

Cherry, 

sour 

Mont 

Morency 

7 

7 

14 

14 

0.012 

0.012 

<0.010 

<0.010 

1.22 

1.23 

0.676 

0.738 

0.100 

0.096 

0.055 

0.059 

0.332 

0.356 

0.236 

0.231 

0.368 

0.362 

0.266 

0.236 

2.032 

2.056 

1.243 

1.274 

RAFNY001 

FN143-05H 

FN143-05H-A 

GLP yes 

2005 

Cherry, 

sweet 

Bing 

7 

7 

14 

14 

0.078 

0.089 

0.07 

0.067 

0.434 

0.592 

0.508 

0.592 

0.031 

0.037 

0.04 

0.04 

0.011 

0.022 

0.029 

0.024 

<0.010 

<0.010 

<0.010 

<0.010 

0.564 

0.75 

0.657 

0.733 

RAFNY001 

FN143-05H 

FN143-05H-B 

GLP yes 

2005 

Cherry, 

sweet 

Bing 

7 

7 

14 

14 

0.035 

0.012 

0.016 

0.058 

0.529 

0.17 

0.247 

0.383 

0.02 

0.02 

0.015 

0.034 

<0.010 

<0.010 

0.023 

0.023 

<0.010 

<0.010 

<0.010 

<0.010 

0.604 

0.222 

0.311 

0.508 

RAFNY001 

FN144-05H 

FN144-05H-A 

GLP yes 

2005 

Cherry, 

sweet 

Bing 

7 

7 

14 

14 

0.062 

0.035 

0.056 

0.068 

0.868 

0.846 

0.838 

0.818 

0.051 

0.035 

0.051 

0.045 

0.110 

0.090 

0.179 

0.189 

0.038 

0.030 

0.051 

0.056 

1.129 

1.036 

1.175 

1.176 

RAFNY001 

FN144-05H 

FN144-05H-B 

GLP yes 

2005 

Cherry, 

sweet 

Bing 

7 

7 

14 

14 

0.014 

0.015 

0.013 

0.014 

1.22 

1.29 

0.96 

1.08 

0.052 

0.069 

0.052 

0.091 

0.147 

0.197 

0.185 

0.246 

0.044 

0.063 

0.077 

0.098 

1.477 

1.634 

1.287 

1.529 
- 382 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Study Residues (ppm) 

Trial No. 

Trial SubID 

GLP 

Year 

Crop 

Variety 

PHI 

(days) BYI 

08330 

BYI 08330 

cis-enol 

BYI 

08330 

cis-ketohydroxy 

BYI 

08330 

monohydroxy 

BYI 

08330 

enolglucoside 

Total 

BYI08330 

calc. * 

RAFNY001 

FN145-05H 

FN145-05H-A 

GLP yes 

2005 

Cherry, 

sweet 

Bing 

0 

0 

7 

7 

10 

10 

14 

14 

21 

21 

0.992 

0.997 

0.026 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.803 

0.811 

0.832 

0.251 

0.095 

0.052 

0.055 

0.092 

0.05 

0.04 

0.043 

0.044 

0.059 

0.011 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.073 

0.077 

0.127 

0.036 

0.03 

<0.010 

0.014 

0.02 

<0.010 

<0.010 

0.016 

0.012 

0.018 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

1.927 

1.941 

1.062 

0.318 

0.155 

0.092 

0.099 

0.142 

0.09 

0.08 

RAFNY001 

FN145-05H 

FN145-05H-B 

GLP yes 

2005 

Cherry, 

sweet 

Bing 

7 

7 

14 

14 

0.018 

0.018 

0.010 

<0.010 

1.23 

1.28 

0.775 

0.678 

0.087 

0.065 

0.069 

0.053 

0.200 

0.223 

0.262 

0.222 

0.047 

0.044 

0.055 

0.040 

1.582 

1.63 

1.171 

1.003 

RAFNY001 

FN144-05H 

FN144-05H-C 

GLP yes 

2005 

Cherry, 

sweet 

Bing 

7 

7 

14 

14 

0.073 

0.061 

0.051 

0.073 

0.487 

0.433 

0.387 

0.576 

0.022 

0.019 

0.014 

0.024 

0.046 

0.044 

0.042 

0.081 

0.018 

0.015 

0.015 

0.026 

0.646 

0.572 

0.509 

0.78 
- 383 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

GRAPES 

Residues 

(ppm) 

Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC 

PHI 

(days) 

BYI 

08330 

BYI 

08330 

cisenol 

BYI 

08330-

ketohydroxy 

BYI 

08330 

monohydroxy 

BYI 08330 

enolglucoside 

Total 

BYI08330 

* 

RAFNY011 

FN212-05H 

USA 

Orefield, 

Pennsylvania 

2005 

Table grape 

berry, table 

grape 

7 

7 

14 

14 

0.094 

0.091 

0.013 

<0.010 

0.106 

0.120 

0.029 

0.019 

0.013 

0.011 

<0.010 

<0.010 

0.011 

<0.010 

<0.010 

<0.010 

0.095 

0.089 

0.030 

0.023 

0.319 

0.321 

0.092 

0.072 

RAFNY011 

FN213-05H 

FN213-05H-A 

USA, Dundee, 

New York, 

2005 

Table grape 

 berry, table 

grape 

7 

7 

14 

14 

0.126 

0.174 

0.080 

0.133 

0.378 

0.404 

0.234 

0.331 

0.012 

0.019 

<0.010 

0.013 

0.036 

0.046 

0.038 

0.042 

0.111 

0.144 

0.109 

0.162 

0.663 

0.787 

0.471 

0.681 

RAFNY011 

FN214-05D 

USA 

Fresno, 

California 

2005 

Table grape 

 berry, table 

grape 

3 

3 

7 

7 

10 

10 

14 

14 

21 

21 

0.055 

0.074 

0.066 

0.076 

0.073 

0.046 

0.102 

0.103 

0.062 

0.062 

0.072 

0.078 

0.093 

0.107 

0.095 

0.088 

0.163 

0.161 

0.100 

0.116 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.028 

0.032 

0.037 

0.038 

0.025 

0.021 

0.057 

0.064 

0.058 

0.055 

0.175 

0.204 

0.216 

0.241 

0.213 

0.175 

0.342 

0.348 

0.24 

0.253 

RAFNY011 

FN215-05H 

FN215-05H-A 

USA 

Plainview, 

California, 

2005 

Table grape 

berry, table 

grape 

7 

7 

14 

14 

0.133 

0.189 

0.136 

0.134 

0.044 

0.048 

0.054 

0.063 

0.020 

0.016 

0.014 

0.016 

<0.010 

<0.010 

<0.010 

<0.010 

0.020 

0.029 

0.025 

0.025 

0.227 

0.292 

0.239 

0.248 

RAFNY011 

FN216-05H 

USA 

Sanger, 

California 

2005 

Table grape 

berry, table 

grape 

7 

7 

14 

14 

0.062 

0.058 

0.029 

0.037 

0.077 

0.076 

0.043 

0.055 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.080 

0.108 

0.058 

0.107 

0.239 

0.262 

0.15 

0.219 

RAFNY011 

FN217-05H 

USA 

Artois, 

California 

2005 

Table grape 

berry, table 

grape 

7 

7 

13 

13 

0.035 

0.041 

0.034 

0.042 

0.018 

0.016 

0.019 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.038 

0.032 

0.060 

0.038 

0.111 

0.109 

0.133 

0.11 

RAFNY011 

FN218-05H 

USA 

Orcutt, 

California 

2005 

Grapes 

(Wine) 

Chardonnay 

7 

7 

14 

14 

0.046 

0.061 

0.064 

0.074 

0.148 

0.258 

0.223 

0.225 

0.013 

0.019 

0.022 

0.018 

<0.010 

<0.010 

<0.010 

<0.010 

0.092 

0.127 

0.170 

0.148 

0.309 

0.475 

0.489 

0.475 

RAFNY011 

FN219-05H 

USA 

Hughson, 

California 

2005 

Table grape 

 berry, table 

grape 

7 

7 

14 

14 

0.156 

0.203 

0.194 

0.181 

0.174 

0.175 

0.295 

0.197 

0.011 

0.013 

0.028 

0.020 

<0.010 

<0.010 

<0.010 

<0.010 

0.089 

0.099 

0.127 

0.102 

0.44 

0.5 

0.654 

0.51 
- 384 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues 

(ppm) 

Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC 

PHI 

(days) 

BYI 

08330 

BYI 

08330 

cisenol 

BYI 

08330-

ketohydroxy 

BYI 

08330 

monohydroxy 

BYI 08330 

enolglucoside 

Total 

BYI08330 

* 

RAFNY011 

FN220-05H 

FN220-05H-A 

USA 

Fresno, 

California 

2005 

Table grape 

berry, table 

grape 

7 

7 

14 

14 

0.114 

0.199 

0.203 

0.087 

0.079 

0.082 

0.113 

0.063 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.036 

0.035 

0.059 

0.036 

0.249 

0.336 

0.395 

0.206 

RAFNY011 

FN221-05H 

USA 

Paso Robles, 

California 

2005 

Table grape 

berry, table 

grape 

7 

7 

14 

14 

0.149 

0.180 

0.332 

0.369 

0.116 

0.151 

0.243 

0.256 

0.023 

0.024 

0.040 

0.045 

<0.010 

<0.010 

<0.010 

<0.010 

0.083 

0.106 

0.144 

0.163 

0.381 

0.471 

0.769 

0.843 

RAFNY011 

FN222-05H 

USA 

Ephrata, 

Washington 

2005 

Table grape 

berry, table 

grape 

7 

7 

14 

14 

0.494 

0.209 

0.246 

0.216 

0.503 

0.344 

0.347 

0.369 

0.206 

0.120 

0.115 

0.090 

<0.010 

<0.010 

<0.010 

<0.010 

0.077 

0.074 

0.074 

0.088 

1.29 

0.757 

0.792 

0.773 

RAFNY011 

FN223-05H 

USA 

Hood River, 

Oregon 

2005 

Table grape 

berry, table 

grape 

7 

7 

14 

14 

0.142 

0.128 

0.130 

0.151 

0.158 

0.167 

0.232 

0.155 

0.015 

0.011 

0.022 

0.018 

<0.010 

<0.010 

0.012 

<0.010 

0.053 

0.048 

0.084 

0.064 

0.378 

0.364 

0.48 

0.398 
- 385 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

TOMATO 

Residues 

(ppm) 

Study 

Trial No. 

Trial SubID 

Location 

Year 

RAC PHI 

(days) BYI08330 BYI08330-

enol 

BYI08330-

ketohydroxy 

BYI08330-

monohydroxy 

BYI08330-

enolglucoside 

Total 

BYI08330 

calc. * 

RAFNY006 Tomato 1 <0.010 0.077 <0.010 <0.010 0.016 0.123 

FN045-04H fruit 1 <0.010 0.078 <0.010 <0.010 0.012 0.12 

USA 3 <0.010 0.133 <0.010 <0.010 0.031 0.194 

Germansville, 3 <0.010 0.101 <0.010 <0.010 0.023 0.154 

Pennsylvania 7 <0.010 0.072 <0.010 <0.010 0.021 0.123 

2004 7 <0.010 0.062 <0.010 <0.010 0.015 0.107 

RAFNY006 Tomato 1 0.025 0.052 <0.010 <0.010 <0.010 0.107 

FN046-04H fruit 1 0.021 0.042 <0.010 <0.010 <0.010 0.093 

FN046-04H-A 3 <0.010 0.058 <0.010 <0.010 <0.010 0.098 

USA 3 <0.010 0.047 <0.010 <0.010 <0.010 0.087 

Tifton, 

Georgia 

 7 <0.010 0.056 <0.010 <0.010 0.021 0.107 

2004 7 <0.010 0.068 <0.010 <0.010 0.023 0.121 

RAFNY006 Tomato 1 <0.010 0.132 0.01 <0.010 <0.010 0.172 

FN047-04HA fruit 1 <0.010 0.165 0.022 <0.010 <0.010 0.217 

USA 3 <0.010 0.13 0.013 <0.010 <0.010 0.173 

Molino, 3 <0.010 0.195 <0.010 <0.010 <0.010 0.235

Florida 7 <0.010 0.227 <0.010 <0.010 0.011 0.268 

2004 7 <0.010 0.215 0.011 <0.010 0.013 0.259 

RAFNY006 Tomato 1 <0.010 0.037 <0.010 <0.010 <0.010 0.077 

FN048-04H fruit 1 <0.010 0.032 <0.010 <0.010 <0.010 0.072 

USA 3 <0.010 0.034 <0.010 <0.010 <0.010 0.074 

Jennings, 3 <0.010 0.032 <0.010 <0.010 <0.010 0.072 

Florida 7 <0.010 0.086 <0.010 <0.010 0.025 0.141 

2004 7 <0.010 0.056 <0.010 <0.010 0.018 0.104 

RAFNY006 Tomato 0 0.022 0.027 <0.010 <0.010 <0.010 0.079 

FN049-04DA fruit 0 0.039 0.031 <0.010 <0.010 <0.010 0.1 

USA 1 <0.010 0.03 <0.010 <0.010 <0.010 0.07 

Stilwell, 1 <0.010 0.02 <0.010 <0.010 <0.010 0.06 

Kansas 4 <0.010 0.025 <0.010 <0.010 <0.010 0.065 

2004 4 <0.010 0.019 <0.010 <0.010 <0.010 0.059 

 7 <0.010 0.025 <0.010 <0.010 0.013 0.068 

 7 <0.010 0.017 <0.010 <0.010 <0.010 0.057 

 10 <0.010 0.017 <0.010 <0.010 <0.010 0.057 

 10 <0.010 0.012 <0.010 <0.010 <0.010 0.052 

RAFNY006 Tomato 1 0.045 0.086 <0.010 <0.010 <0.010 0.161 

FN050-04H fruit 1 0.034 0.163 <0.010 <0.010 <0.010 0.227 

FN050-04H-A 3 0.048 0.104 <0.010 <0.010 <0.010 0.182 

USA 3 0.043 0.129 <0.010 <0.010 0.011 0.203 

Fresno, 

California 

 7 0.043 0.153 <0.010 <0.010 0.017 0.233 

2004 7 0.035 0.153 <0.010 <0.010 0.018 0.226 

RAFNY006 Tomato 1 0.077 0.108 <0.010 <0.010 0.013 0.218 

FN051-04H fruit 1 0.077 0.102 <0.010 <0.010 0.011 0.21 

FN051-04H-A 3 0.062 0.079 <0.010 <0.010 0.013 0.174

USA 3 0.064 0.101 <0.010 <0.010 0.019 0.204 

Glenn, 

California 

 7 0.06 0.161 <0.010 <0.010 <0.010 0.251 
- 386 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues 

(ppm) 

Study 

Trial No. 

Trial SubID 

Location 

Year 

RAC PHI 

(days) BYI08330 BYI08330-

enol 

BYI08330-

ketohydroxy 

BYI08330-

monohydroxy 

BYI08330-

enolglucoside 

Total 

BYI08330 

calc. * 

2004 7 0.072 0.146 <0.010 <0.010 <0.010 0.248 

RAFNY006 Tomato 1 0.014 0.1 <0.010 <0.010 <0.010 0.144 

FN052-04H fruit 1 <0.010 0.103 <0.010 <0.010 <0.010 0.143 

USA 4 <0.010 0.11 <0.010 <0.010 <0.010 0.15 

Paso Robles, 4 <0.010 0.103 <0.010 <0.010 <0.010 0.143 

California 7 <0.010 0.194 <0.010 <0.010 <0.010 0.234 

2004 7 <0.010 0.202 <0.010 <0.010 <0.010 0.242 

RAFNY006 Tomato 1 0.051 0.08 <0.010 <0.010 <0.010 0.161 

FN053-04H fruit 1 0.047 0.092 <0.010 <0.010 <0.010 0.169 

USA 3 0.018 0.061 <0.010 <0.010 <0.010 0.109 

Visalia, 3 0.012 0.038 <0.010 <0.010 <0.010 0.08 

California 7 <0.010 0.046 <0.010 <0.010 <0.010 0.086 

2004 7 <0.010 0.051 <0.010 <0.010 <0.010 0.091 

RAFNY006 Tomato 1 0.012 0.071 <0.010 <0.010 <0.010 0.113 

FN054-04H fruit 1 0.01 0.071 <0.010 <0.010 <0.010 0.111 

USA 3 0.017 0.131 <0.010 <0.010 0.015 0.183 

Porterville, 3 0.017 0.133 <0.010 <0.010 0.018 0.188 

California 7 <0.010 0.129 <0.010 <0.010 0.014 0.173 

2004 7 <0.010 0.158 <0.010 <0.010 0.021 0.209 

RAFNY006 Tomato 1 0.014 0.087 <0.010 <0.010 <0.010 0.131 

FN055-04H fruit 1 0.025 0.123 <0.010 <0.010 0.012 0.18 

USA 3 <0.010 0.098 <0.010 <0.010 <0.010 0.138 

Fresno, 3 <0.010 0.086 <0.010 <0.010 <0.010 0.126

California 7 0.016 0.146 <0.010 <0.010 0.016 0.198

2004 7 0.022 0.229 <0.010 <0.010 0.035 0.306 

RAFNY006 Tomato 1 0.014 0.063 <0.010 <0.010 <0.010 0.107 

FN056-04H fruit 1 0.025 0.088 <0.010 <0.010 <0.010 0.143 

USA 3 0.017 0.058 <0.010 <0.010 <0.010 0.105 

Madera, 3 0.013 0.077 <0.010 <0.010 <0.010 0.12 

California 7 0.019 0.088 <0.010 <0.010 0.018 0.145

2004 7 0.029 0.087 0.01 <0.010 0.016 0.152 

PEPPER 

Residues 

(ppm) 

Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC 

PHI 

(days) BYI08330 BYI08330-enol 

BYI08330-

ketohydroxy 

BYI08330-

monohydroxy 

BYI08330-

enolglucoside 

Total 

BYI08330 

calc. * 

RAFNY006 

FN057-04D 

USA 

Tifton, 

Georgia 

2004 

Pepper, 

sweet 

fruit 

0 

0 

1 

1 

3 

3 

7 

7 

10 

10 

0.011 

0.011 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.051 

0.059 

0.093 

0.089 

0.077 

0.099 

0.190 

0.108 

0.087 

0.191 

0.019 

0.023 

0.049 

0.037 

0.045 

0.038 

0.060 

0.053 

0.045 

0.051 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.022 

0.018 

0.023 

0.033 

0.101 

0.113 

0.172 

0.156 

0.152 

0.167 

0.292 

0.199 

0.175 

0.295 
- 387 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Residues 

(ppm) 

Study 

Trial No. 

Trial SubID 

Country 

Year 

RAC 

PHI 

(days) BYI08330 BYI08330-enol 

BYI08330-

ketohydroxy 

BYI08330-

monohydroxy 

BYI08330-

enolglucoside 

Total 

BYI08330 

calc. * 

RAFNY006 

FN058-04H 

FN058-

04H-A 

USA 

Molino, 

Florida 

2004 

Pepper, 

sweet 

fruit 

1 

1 

3 

3 

7 

7 

<0.010 

<0.010 

0.013 

0.014 

<0.010 

<0.010 

0.102 

0.148 

0.286 

0.492 

0.361 

0.258 

0.058 

0.092 

0.120 

0.205 

0.145 

0.137 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.011 

0.017 

0.034 

0.054 

0.057 

0.062 

0.191 

0.277 

0.463 

0.775 

0.583 

0.477 

RAFNY006 

FN059-04H 

USA 

Springfield, 

Nebraska 

2004 

Pepper, 

sweet 

fruit 

1 

1 

4 

4 

7 

7 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.394 

0.232 

0.276 

0.269 

0.242 

0.615 

0.139 

0.112 

0.119 

0.134 

0.083 

0.233 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.017 

0.016 

0.015 

0.018 

0.020 

0.051 

0.57 

0.38 

0.43 

0.441 

0.365 

0.919 

RAFNY006 

FN060-04H 

USA 

East 

Bernard, 

Texas 

2004 

Pepper, 

sweet 

fruit 

1 

1 

3 

3 

7 

7 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.204 

0.263 

0.204 

0.210 

0.203 

0.247 

0.039 

0.069 

0.037 

0.051 

0.065 

0.036 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.273 

0.362 

0.271 

0.291 

0.298 

0.313 

RAFNY006 

FN061-04H 

FN061-

04H-A 

USA 

Fresno, 

California 

2004 

Pepper, 

sweet 

fruit 

1 

1 

3 

3 

7 

7 

0.025 

0.033 

0.026 

0.016 

<0.010 

0.014 

0.530 

0.489 

0.690 

0.609 

0.446 

0.749 

0.096 

0.075 

0.078 

0.116 

0.131 

0.229 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.021 

0.022 

0.031 

0.027 

0.033 

0.068 

0.682 

0.629 

0.835 

0.778 

0.63 

1.07 

RAFNY006 

FN062-04H 

USA 

Hickman, 

California 

2004 

Pepper, 

sweet 

fruit 

1 

1 

3 

3 

7 

7 

0.046 

0.034 

0.028 

0.049 

0.035 

0.032 

0.208 

0.106 

0.183 

0.374 

0.271 

0.413 

0.047 

0.042 

0.057 

0.050 

0.057 

0.070 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.012 

0.013 

0.024 

0.321 

0.202 

0.288 

0.495 

0.386 

0.549 

CUCUMBER 

Study Residues (mg/kg) 

Trial No. 

Trial SubID 

Country 

GLP 

Year 

Crop 

Portion 

analyse

d 

DALT

a

(days

) 

BYI 08330 BYI 08330 

cis-enol 

BYI 08330 

cis-ketohydroxy 

BYI 08330 

monohydroxy 

BYI 08330 

enolglucoside 

Total 

Residue 

of BYI 

08330 

calc. 

RAFNY007 

FN066-04H 

FN066-04H-A 

Tifton, Georgia 

2004 

Cucumb

er 

fruit 

1 

1 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.050 

<0.050 

RAFNY007 

FN067-04H 

Louisa, Virginia 

2004 

Cucumb

er 

fruit 

1 

1 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.033 

<0.010 

<0.010 

<0.010 

<0.010 

<0.050 

0.073 

RAFNY007 

FN068-04HA 

Molino, Florida 

2004 

Cucumb

er 

fruit 

1 

1 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.050 

<0.050 
- 388 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Study Residues (mg/kg) 

Trial No. 

Trial SubID 

Country 

GLP 

Year 

Crop 

Portion 

analyse

d 

DALT

a

(days

) 

BYI 08330 BYI 08330 

cis-enol 

BYI 08330 

cis-ketohydroxy 

BYI 08330 

monohydroxy 

BYI 08330 

enolglucoside 

Total 

Residue 

of BYI 

08330 

calc. 

RAFNY007 

FN069-04D 

Stilwell, Kansas 

2004 

Cucumb

er 

fruit 

0 

0 

1 

1 

1 

6 

6 

9 

9 

0.012 

0.017 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.052 

0.057 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

 whole 

fruit, 

washed 

1 <0.010 <0.010 <0.010 <0.010 <0.010 <0.050 

 fruit 

without 

peel 

1 <0.010 <0.010 <0.010 <0.010 <0.010 <0.050 

RAFNY007 

FN070-04H 

FN070-04H-A 

Seymour, Illinois 

2004 

Cucumb

er 

fruit 

1 

1 

<0.010 

<0.010 

<0.010 

<0.010 

0.014 

0.017 

<0.010 

<0.010 

<0.010 

<0.010 

0.054 

0.057 

RAFNY007 

FN071-04H 

Eagle Lake, 

Texas 

2004 

Cucumb

er 

fruit 

1 

1 

0.034 

0.029 

<0.010 

0.010 

0.012 

0.014 

<0.010 

<0.010 

<0.010 

<0.010 

0.076 

0.073 

Cucumbers- 240 SC formulation 

RAFNY007 

FN066-04H 

FN066-04H-B 

Tifton, Georgia 

2004 

Cucumb

er 

fruit 

1 

1 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.050 

<0.050 

RAFNY007 

FN070-04H 

FN070-04H-B 

Seymour, Illinois 

2004 

Cucumb

er 

fruit 

1 

1 

<0.010 

<0.010 

<0.010 

<0.010 

0.017 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.057 

<0.050 

MELON 

RAFNY007 

FN072-04HA 

Molino, Florida 

2004 

Melon, 

cantalo

up 

fruit 

1 

1 

<0.010 

<0.010 

0.013 

<0.010 

0.014 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.057 

<0.050 
- 389 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

RAFNY007 

FN073-04D 

Valley, Nebraska 

2004 

Melon, 

cantalo

up 

fruit 

0 

0 

1 

1 

1 

3 

3 

7

7

10 

10 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

 fruit 

without 

peel 

1 <0.010 <0.010 <0.010 <0.010 <0.010 <0.050 

RAFNY007 

FN074-04H 

Uvalde, Texas 

2004 

Melon, 

cantalo

up 

fruit 

2 

2 

0.069 

0.020 

0.035 

0.012 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.134 

0.062 

RAFNY007 

FN075-04H 

FN075-04H-A 

Fresno, 

California 

2004 

Melon, 

cantalo

up 

fruit 

1 

1 

0.028 

0.016 

0.025 

0.018 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.083 

0.064 

RAFNY007 

FN076-04H 

FN076-04H-A 

El Centro, 

California 

2004 

Melon, 

cantalo

up 

fruit 

1 

1 

<0.010 

0.011 

0.016 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.056 

0.051 

RAFNY007 

FN077-04H 

Orland, California 

2004 

Melon, 

cantalo

up 

fruit 

1 

1 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.050 

<0.050 

Muskmelon – 240 SC formulation 

RAFNY007 

FN075-04H 

FN075-04H-B 

Fresno, 

California 

2004 

Melon, 

cantalo

up 

fruit 

1 

1 

0.015 

<0.010 

0.012 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.057 

<0.050 

RAFNY007 

FN076-04H 

FN076-04H-B 

El Centro, 

California 

2004 

Melon, 

cantalo

up 

fruit 

1 

1 

0.017 

0.077 

0.016 

0.056 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.063 

0.163 

Summer Squash – 100 OD formulation 

RAFNY007 

FN078-04H 

Germansville, 

Pennsylvania 

2004 

Squash, 

summer 

fruit 

1 

1 

3 

3 

7

7

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.078 

0.055 

0.025 

0.016 

<0.010 

<0.010 

0.076 

0.076 

0.052 

0.055 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.184 

0.161 

0.107 

0.101 

<0.050 

<0.050 
- 390 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

RAFNY007 

FN079-04D 

Tifton, Georgia 

2004 

Squash, 

summer 

fruit 

0 

0 

1 

1 

1 

3 

3 

7

7

10 

10 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.015 

<0.010 

<0.010 

0.011 

<0.010 

0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.055 

<0.050 

<0.050 

0.051 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

<0.050 

 fruit, 

cooked 

1 <0.010 0.021 <0.010 <0.010 <0.010 0.061 

 fruit 

without 

peel 

1 <0.010 <0.010 <0.010 <0.010 <0.010 <0.050 

 whole 

fruit, 

washed 

1 <0.010 <0.010 <0.010 <0.010 <0.010 <0.050 

RAFNY007 

FN080-04HA 

Molino, Florida 

2004 

Squash, 

summer 

fruit 

1 

1 

3 

3 

7

7

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.014 

0.010 

<0.010 

0.011 

<0.010 

<0.010 

0.033 

0.019 

0.017 

0.033 

0.015 

0.011 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.077 

0.059 

0.057 

0.074 

0.055 

0.051 

RAFNY007 

FN081-04H 

FN081-04H-A 

Valley, Nebraska 

2004 

Squash, 

summer 

fruit 

1 

1 

3 

3 

7

7

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.013 

0.020 

0.013 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.053 

0.060 

0.053 

<0.050 

<0.050 

<0.050 

RAFNY007 

FN082-04H 

Fresno, 

California 

2004 

Squash, 

summer 

fruit 

1 

1 

3 

3 

7

7

0.062 

0.045 

0.077 

0.042 

<0.010 

0.020 

0.043 

0.034 

0.050 

0.028 

<0.010 

0.015 

0.017 

<0.010 

0.014 

0.013 

<0.010 

0.012 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.142 

0.109 

0.161 

0.103 

<0.050 

0.067 
- 391 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

FLOWERING BRASSICA 

Trial ID 

(City, 

State/Year) 

Commodity 

or Matrix 

Total 

Rate 

(lb 

a.i./A) 

(kg 

a.i./ha) 

PHI 

(days) 

BYI 

08330 

(ppm) 

BYI 

08330-

enol 

(ppm) 

BYI 08330-

ketohydroxy 

(ppm) 

BYI 

08330-

monohydroxy 

(ppm) 

BYI 

08330-

enolGlc 

(ppm) 

Total 

Residues 

of BYI 

08330 

(ppm) 

Uvalde, 

Texas 

Region 6 

Broccoli 

flower head 

100OD 

0.158 

(0.177) 

1 

1 

3 

3 

7 

7 

0.025 

0.030 

0.031 

0.036 

<0.010

<0.010 

0.164 

0.118 

0.278 

0.272 

0.265 

0.229 

0.160 

0.164 

0.382 

0.432 

0.523 

0.459 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

0.040 

0.032 

0.063 

0.071 

0.369 

0.332 

0.741 

0.782 

0.871 

0.779 

Uvalde, 

Texas 

Region 6 

Broccoli 

flower head 

240 

SC 

0.157 

(0.176) 

1 

1 

3 

3 

7 

7 

0.034 

0.023 

0.024 

0.015 

0.011 

<0.010 

0.121 

0.118 

0.166 

0.137 

0.229 

0.384 

0.150 

0.127 

0.271 

0.164 

0.377 

0.398 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

0.019 

0.005 

0.045 

0.033 

0.325 

0.288 

0.49 

0.331 

0.672 

0.835 

Broccoli 

flower head 

0 

0 

1 

1 

1 

3 

3 

7 

7 

10 

10 

0.123 

0.147 

0.057 

0.056 

0.029 

0.045 

0.065 

0.039 

0.040 

<0.010

<0.010 

0.138 

0.108 

0.128 

0.095 

0.061 

0.089 

0.104 

0.131 

0.171 

0.124 

0.147 

0.272 

0.194 

0.201 

0.216 

0.230 

0.241 

0.209 

0.356 

0.315 

0.328 

0.286 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

0.011 

0.012 

0.015 

0.012 

0.553 

0.469 

0.406 

0.387 

*0.34 

0.395 

0.398 

0.547 

0.548 

0.487 

0.465 

head, 

cooked 

1 <0.010 0.314 0.016 <0.010 <0.010 0.360 

Fresno, 

California 

Region 10 

head, 

washed 

100OD 

0.157 

(0.176) 

1 <0.010 0.055 0.211 <0.010 <0.010 0.296 

Hickman, 

California 

Region 10 

Broccoli 

flower head 

100OD 

0.154 

(0.173) 

1 

1 

3 

3 

7 

7 

0.022 

0.027 

<0.010

<0.010

<0.010

<0.010 

0.023 

0.033 

0.051 

0.056 

0.085 

0.068 

0.034 

0.027 

0.053 

0.050 

0.063 

0.068 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.099 

0.107 

0.134 

0.136 

0.178 

0.166 

King City, 

California 

Region 10 

Cauliflower 

flower head 

100 

OD 

0.158 

(0.178) 

1 

1 

3 

3 

7 

7 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.093 

0.102 

0.048 

0.059 

0.094 

0.059 

0.201 

0.213 

0.153 

0.131 

0.190 

0.106 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.324 

0.345 

0.231 

0.22 

0.314 

0.195 

King City, 

California 

Region 10 

Cauliflower 

flower head 

240 

SC 

0.156 

(0.176) 

1 

1 

3 

3 

7 

7 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.045 

0.065 

0.055 

0.066 

0.028 

0.027 

0.135 

0.194 

0.140 

0.130 

0.098 

0.087 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.21 

0.289 

0.225 

0.226 

0.156 

0.144 
- 392 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Trial ID 

(City, 

State/Year) 

Commodity 

or Matrix 

Total 

Rate 

(lb 

a.i./A) 

(kg 

a.i./ha) 

PHI 

(days) 

BYI 

08330 

(ppm) 

BYI 

08330-

enol 

(ppm) 

BYI 08330-

ketohydroxy 

(ppm) 

BYI 

08330-

monohydroxy 

(ppm) 

BYI 

08330-

enolGlc 

(ppm) 

Total 

Residues 

of BYI 

08330 

(ppm) 

Glenn, 

California 

Region 10 

Cauliflower 

flower head 

100 

OD 

0.155 

(0.173) 

1 

1 

3 

3 

7 

7 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.214 

0.176 

0.227 

0.227 

0.270 

0.230 

0.207 

0.189 

0.178 

0.213 

0.242 

0.245 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.451 

0.395 

0.435 

0.47 

0.542 

0.505 

Corvallis, 

Oregon 

Region 12 

Cauliflower 

flower head 

100 

OD 

0.157 

(0.177) 

1 

1 

3 

3 

7 

7 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.063 

0.058 

0.045 

0.056 

0.091 

0.070 

0.318 

0.318 

0.267 

0.219 

0.315 

0.302 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.010 

0.011 

0.012 

<0.010

0.020 

0.019 

0.411 

0.407 

0.344 

0.305 

0.446 

0.411 

HEAD CABBAGE 

Trial ID 

(City, 

State/Year) 

Commodity 

or Matrix 

Total 

Rate 

(lb 

a.i./A) 

(kg 

a.i./ha) 

PHI 

(days) 

BYI 

08330 

(ppm) 

BYI 

08330-

enol 

(ppm) 

BYI 08330-

ketohydroxy 

(ppm) 

BYI 

08330-

monohydroxy 

(ppm) 

BYI 

08330-

enolGlc 

(ppm) 

Total 

Residues 

of BYI 

08330 

(ppm) 

Cabbage, 

field 

head 

1 

1 

3 

3 

7 

7 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

<0.010

<0.010

0.013 

0.011 

<0.010

<0.010 

0.017 

0.014 

0.024 

0.022 

0.023 

0.020 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

0.011 

0.057 

0.054 

0.067 

0.063 

0.063 

0.061 

Tifton, 

Georgia 

Region 2 

head, 

trimmed 

100 

OD 

0.157 

(0.176) 

1 

1 

3 

3 

7 

7 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

<0.010

<0.010

<0.010

0.012 

<0.010

<0.010 

0.022 

0.026 

0.024 

0.015 

0.016 

0.022 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.062 

0.066 

0.064 

0.057 

0.056 

0.062 

Cabbage, 

field 

head 

1 

1 

3 

3 

7 

7 

0.757 

0.693 

0.156 

0.084 

0.048 

0.068 

0.129 

0.099 

0.037 

0.026 

0.025 

0.028 

<0.010 

0.085 

0.079 

0.064 

0.057 

0.054 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.018 

<0.010

0.037 

0.026 

0.025 

0.028 

0.924 

0.897 

0.319 

0.21 

0.165 

0.188 

Bumpass, 

VA Region 

1 

head, 

trimmed 

100 

OD 

0.157 

(0.176) 

1 

1 

3 

3 

7 

7 

0.052 

0.034 

<0.010

<0.010

<0.010

<0.010 

0.035 

0.036 

0.025 

0.030 

0.018 

0.024 

0.063 

0.068 

0.074 

0.075 

0.060 

0.066 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.17 

0.158 

0.129 

0.135 

0.108 

0.12 

Tifton, 

Georgia 

Region 2 

Cabbage, 

field 

head 

240 

SC 

0.157 

(0.176) 

1 

1 

3 

3 

7 

7 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

<0.010 

<0.010 

0.016 

0.011 

0.010 

0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.05 

0.05 

0.056 

0.051 

0.05 

0.05 
- 393 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Trial ID 

(City, 

State/Year) 

Commodity 

or Matrix 

Total 

Rate 

(lb 

a.i./A) 

(kg 

a.i./ha) 

PHI 

(days) 

BYI 

08330 

(ppm) 

BYI 

08330-

enol 

(ppm) 

BYI 08330-

ketohydroxy 

(ppm) 

BYI 

08330-

monohydroxy 

(ppm) 

BYI 

08330-

enolGlc 

(ppm) 

Total 

Residues 

of BYI 

08330 

(ppm) 

head, 

trimmed 

1 

1 

3 

3 

7 

7 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.016 

0.015 

0.012 

0.017 

0.020 

0.014 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.056 

0.055 

0.052 

0.057 

0.06 

0.054 

Cabbage, 

field 

head 

1 

1 

3 

3 

7 

7 

0.329 

0.303 

0.053 

0.045 

0.059 

0.023 

0.170 

0.157 

0.125 

0.102 

0.151 

0.159 

0.123 

0.166 

0.174 

0.128 

0.217 

0.197 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

0.012 

0.016 

0.642 

0.646 

0.372 

0.295 

0.449 

0.405 

Molino, 

Florida 

Region 3 

head, 

trimmed 

100 

OD 

0.153 

(0.171) 

1 

1 

3 

3 

7 

7 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.020 

0.029 

0.052 

0.036 

0.055 

0.039 

0.050 

0.052 

0.089 

0.066 

0.088 

0.074 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.1 

0.111 

0.171 

0.132 

0.173 

0.143 

Cabbage, 

field 

head 

0 

0 

1 

1 

3 

3 

7 

7 

10 

10 

0.073 

0.092 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.081 

0.096 

0.085 

0.057 

0.061 

0.061 

0.067 

0.044 

0.032 

0.039 

0.107 

0.096 

0.109 

0.097 

0.146 

0.111 

0.131 

0.108 

0.073 

0.101 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.018 

0.013 

0.017 

0.015 

0.014 

0.011 

0.021 

0.018 

0.016 

0.026 

0.289 

0.307 

0.231 

0.189 

0.241 

0.203 

0.239 

0.19 

0.141 

0.186 

head, 

cooked 

1 <0.010 0.124 <0.010 <0.010 <0.010 0.164 

Stilwell, 

Kansas 

Region 5 

head, 

trimmed 

100 

OD 

0.158 

(0.178) 

1 <0.010 0.026 0.059 <0.010 0.011 0.116 

Cabbage, 

field 

head 

1 

1 

3 

3 

7 

7 

0.182 

0.123 

0.113 

0.140 

<0.010

0.011 

0.090 

0.088 

0.102 

0.093 

0.040 

0.040 

0.156 

0.162 

0.209 

0.256 

0.096 

0.127 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

0.011 

0.016 

0.014 

0.016 

0.448 

0.393 

0.445 

0.515 

0.17 

0.204 

East 

Bernard, 

Texas 

Region 6 

head, 

trimmed 

100 

OD 

0.156 

(0.176) 

1 

1 

3 

3 

7 

7 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.016 

0.018 

0.029 

0.027 

0.031 

0.050 

0.053 

0.042 

0.108 

0.101 

0.158 

0.110 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.099 

0.09 

0.167 

0.158 

0.219 

0.19 

Fresno, 

California 

Region 10 

Cabbage, 

field 

head 

100 

OD 

0.153 

(0.172) 

1 

1 

3 

3 

7 

7 

0.059 

0.058 

0.078 

0.115 

0.052 

0.060 

0.029 

0.028 

0.029 

0.037 

0.029 

0.031 

0.014 

0.016 

0.015 

0.020 

0.025 

0.026 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.122 

0.122 

0.142 

0.192 

0.126 

0.137 
- 394 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Trial ID 

(City, 

State/Year) 

Commodity 

or Matrix 

Total 

Rate 

(lb 

a.i./A) 

(kg 

a.i./ha) 

PHI 

(days) 

BYI 

08330 

(ppm) 

BYI 

08330-

enol 

(ppm) 

BYI 08330-

ketohydroxy 

(ppm) 

BYI 

08330-

monohydroxy 

(ppm) 

BYI 

08330-

enolGlc 

(ppm) 

Total 

Residues 

of BYI 

08330 

(ppm) 

head, 

trimmed 

1 

1 

3 

3 

7 

7 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.013 

0.012 

0.024 

<0.010

0.012 

0.014 

0.017 

0.010 

0.024 

0.020 

0.025 

0.020 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010 

0.06 

0.052 

0.078 

0.06 

0.067 

0.064 

LEAFY BRASSICA 

Trial ID 

(City, 

State/Year) 

Commodity 

or Matrix 

Total 

Rate 

(lb 

a.i./A) 

(kg 

a.i./ha) 

PHI 

(days) 

BYI 

08330 

(ppm) 

BYI 

08330-

enol 

(ppm) 

BYI 08330-

ketohydroxy 

(ppm) 

BYI 

08330-

monohydroxy 

(ppm) 

BYI 

08330-

enolGlc 

(ppm) 

Total 

Residues 

of BYI 

08330 

(ppm) 

Tifton, 

Georgia 

Region 2 

Mustard 

Greens 

100 

OD 

0.157 

(0.176) 

1 

1 

3 

3 

7 

7 

0.176 

0.159 

0.049 

0.058 

<0.010

<0.01 

1.098 

1.091 

0.348 

0.357 

0.091 

0.097 

0.338 

0.354 

0.177 

0.206 

0.051 

0.050 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.111 

0.076 

0.104 

0.091 

0.096 

0.078 

1.733 

1.69 

0.688 

0.722 

0.258 

0.245 

Frenchtown, 

New Jersey 

Region 2 

Mustard 

Greens 100 

OD 

0.164 

(0.184) 

1 

1 

3 

3 

7 

7 

1.743 

1.549 

0.960 

1.126 

0.146 

0.117 

3.216 

3.167 

2.036 

2.447 

1.197 

1.204 

0.503 

0.487 

0.428 

0.539 

0.257 

0.275 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.018 

0.013 

0.017 

0.031 

0.053 

0.048 

5.49 

5.226 

3.451 

4.153 

1.663 

1.654 

Oviedo, 

Florida 

Region 3 

Mustard 

Greens 

100 

OD 

0.153 

(0.171) 

1 

1 

3 

3 

7 

7 

0.683 

0.668 

0.119 

0.175 

0.023 

0.011 

2.295 

2.292 

1.472 

1.428 

0.694 

0.593 

0.692 

0.800 

0.499 

0.515 

0.327 

0.323 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.262 

0.245 

0.394 

0.300 

0.245 

0.347 

3.942 

4.015 

2.494 

2.428 

1.299 

1.284 

Leland, 

Mississippi 

Region 3 

Mustard 

Greens 

0 

0 

1 

1 

1 

3 

3 

7 

7 

10 

10 

0.023 

0.011 

0.026 

<0.010

1.714 

1.917 

2.675 

2.422 

3.331 

1.439 

1.386 

0.081 

0.067 

0.045 

0.048 

2.031 

1.621 

1.524 

1.332 

2.032 

0.977 

1.398 

0.560 

0.706 

0.668 

0.628 

0.616 

0.401 

0.307 

0.094 

0.133 

0.083 

0.092 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.041 

0.035 

0.067 

0.075 

0.097 

0.127 

0.102 

0.125 

0.092 

0.059 

0.085 

0.715 

0.829 

0.816 

0.771 

*4.468 

4.076 

4.618 

3.983 

5.598 

2.568 

2.971 

Washed 

cooked 

greens 

 1 <0.010 0.399 0.014 <0.010 <0.010 0.443 

Washed 

greens 

100 

OD 

0.156 

(0.175) 

1 0.246 0.474 0.575 <0.010 0.070 1.375 
- 395 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

Trial ID 

(City, 

State/Year) 

Commodity 

or Matrix 

Total 

Rate 

(lb 

a.i./A) 

(kg 

a.i./ha) 

PHI 

(days) 

BYI 

08330 

(ppm) 

BYI 

08330-

enol 

(ppm) 

BYI 08330-

ketohydroxy 

(ppm) 

BYI 

08330-

monohydroxy 

(ppm) 

BYI 

08330-

enolGlc 

(ppm) 

Total 

Residues 

of BYI 

08330 

(ppm) 

Seymour, 

Illinois 

Region 5 

Mustard 

Greens 

100 

OD 

0.155 

(0.174) 

1 

1 

3 

3 

7 

7 

0.058 

0.056 

0.030 

0.041 

<0.010

0.011 

0.511 

0.553 

0.367 

0.534 

0.196 

0.228 

0.190 

0.189 

0.209 

0.213 

0.117 

0.106 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.036 

0.039 

0.071 

0.068 

0.059 

0.043 

0.805 

0.847 

0.687 

0.866 

0.392 

0.398 

Seymour, 

Illinois 

Region 5 

Mustard 

Greens 

240 

SC 

0.155 

(0.174) 

1 

1 

3 

3 

7 

7 

0.042 

0.041 

0.025 

0.023 

<0.010

<0.010 

0.591 

0.540 

0.458 

0.461 

0.190 

0.212 

0.195 

0.168 

0.186 

0.215 

0.102 

0.106 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.023 

0.025 

0.041 

0.039 

0.039 

0.039 

0.861 

0.784 

0.72 

0.748 

0.351 

0.377 

East 

Bernard, 

Texas 

Region 6 

Mustard 

Greens 

100 

OD 

0.158 

(0.177) 

1 

1 

3 

3 

7 

7 

0.369 

0.428 

0.148 

0.160 

0.150 

0.088 

0.334 

0.210 

1.405 

1.332 

1.200 

1.149 

0.493 

0.534 

0.403 

0.337 

0.144 

0.209 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.039 

0.041 

0.039 

0.038 

0.030 

0.031 

1.245 

1.223 

2.005 

1.877 

1.534 

1.487 

Fresno, 

California 

Region 10 

Mustard 

Greens 

100 

OD 

0.156 

(0.175) 

1 

1 

3 

3 

7 

7 

1.160 

1.240 

0.861 

0.731 

0.042 

0.030 

1.405 

1.332 

1.200 

1.149 

0.386 

0.361 

0.758 

0.754 

0.669 

0.558 

0.176 

0.201 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.045 

0.042 

0.095 

0.072 

0.032 

0.034 

3.378 

3.378 

2.835 

2.52 

0.646 

0.636 

Fresno, 

California 

Region 10 

Mustard 

Greens 

240 

SC 

0.157 

(0.176) 

1 

1 

3 

3 

7 

7 

1.719 

1.678 

0.741 

0.915 

0.029 

0.026 

1.565 

1.594 

0.928 

1.138 

0.339 

0.335 

1.010 

1.140 

0.615 

0.767 

0.191 

0.198 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.035 

0.038 

0.039 

0.045 

0.024 

0.021 

4.339 

4.46 

2.333 

2.875 

0.593 

0.59 

Oxnard, 

California 

Region 10 

Mustard 

Greens 

100 

OD 

0.159 

(0.178) 

1 

1 

3 

3 

7 

7 

2.029 

1.985 

1.750 

1.546 

0.170 

0.148 

0.930 

1.040 

0.891 

0.861 

0.449 

0.518 

1.292 

1.146 

0.840 

0.854 

0.327 

0.325 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

<0.010 

0.026 

0.024 

0.031 

0.028 

0.019 

0.020 

4.287 

4.205 

3.522 

3.299 

0.975 

1.021 
- 396 - 

Spirotetramat – Volume 3, Annex B.7 Residue data April 2008 

HOPS 

Residues (ppm) Study 

Trial No. 

Trial SubID 

City, State 

Year 

EP1

PHI2

(days

) 

BYI 

08330 

BYI 

08330 

cis-enol 

BYI 

08330 

cis-ketohydroxy 

BYI 

08330 

monohydroxy 

BYI 

08330 

enolglucosid

e 

Total 

BYI08330 

calc. 3

RAFNY022 

FN229-05H 

Greenleaf, Idaho 

2005 

150 OD 7 

7 

14 

14 

4.242 

3.946 

2.916 

3.131 

0.639 

0.501 

0.494 

0.483 

0.202 

0.156 

0.232 

0.270 

<0.10 

<0.10 

<0.10 

<0.10 

0.637 

0.456 

0.689 

0.792 

5.82 

5.159 

4.431 

4.776 

RAFNY022 

FN230-05H 

Woodburn, 

Oregon 

2005 

150 OD 8 

8 

14 

14 

4.083 

3.676 

3.634 

3.554 

0.744 

0.705 

0.684 

0.515 

0.220 

0.206 

0.298 

0.196 

<0.10 

<0.10 

<0.10 

<0.10 

0.663 

0.488 

0.652 

0.594 

5.81 

5.175 

5.368 

4.959 

RAFNY022 

FN231-05H 

FN231-05H-A 

Yakima, 

Washington 

2005 

150 OD 7 

7 

14 

14 

1.590 

1.430 

1.806 

1.623 

0.236 

0.451 

0.377 

0.344 

<0.10 

<0.10 

<0.10 

<0.10 

<0.10 

<0.10 

<0.10 

<0.10 

0.138 

0.355 

0.395 

0.404 

2.164 

2.436 

2.778 

2.571