Registration Report Part B Section 4 · prune and tomato past, respectively. Concerning the...

Part B – Section 4

National Assessment

Batavia

Registration Report

of 26

Applicant: Bayer CropScience Evaluator: Ctgb-NL

Date: January 2019

Art. 51

Extension of authorisation for minor uses

REGISTRATION REPORT

Part B

Section 4: Metabolism and Residues

Detailed summary of the risk assessment

Product code: 102000016538

Active Substance: Spirotetramat SC 100 (100

g/L)

Member State: The Netherlands

NATIONAL ASSESSMENT

Applicant: Bayer CropScience

Date: January 2019


National Assessment

Batavia

Registration Report

of 26


Date: January 2019

Table of Contents

IIIA 8 METABOLISM AND RESIDUES DATA ...................................................................... 4

IIIA 8.1 Stability of Residues .......................................................................................................... 5

IIIA 8.2 Supplementary studies on metabolism in plants or livestock ........................................ 5

IIIA 8.3 Supplementary residue trials (supervised field trials) ................................................... 6

IIIA 8.3.1 Other leafy vegetables excluding witloof chicory (watercress, lamb’s lettuce,

rocket, sea lavender) ......................................................................................................... 6

IIIA 8.3.2 Endive ............................................................................................................................... 12

IIIA 8.3.3 Baby leaf crops ................................................................................................................ 12

IIIA 8.3.4 Leafy brassica .................................................................................................................. 12

IIIA 8.3.5 Aromatic herbs ................................................................................................................ 18

IIIA 8.4 Supplementary Livestock Feeding Studies ................................................................... 18

IIIA 8.5 Supplementary Studies on Industrial Processing and/or Household

Preparation ...................................................................................................................... 18

IIIA 8.6 Supplementary Studies for Residues in Representative Succeeding Crops ............... 18

IIIA 8.7 Proposed Residue Definition and Maximum Residue Levels ...................................... 19

IIIA 8.7.1 Proposed residue definition ............................................................................................ 19

IIIA 8.7.2 Proposed maximum residue levels (MRLs) .................................................................. 19

IIIA 8.8.1 Pre-harvest interval (in days) for each relevant crop .................................................. 20

IIIA 8.8.2 Re-entry period (in days) for livestock, to areas to be grazed ..................................... 20

IIIA 8.8.3 Re-entry period for man to crops, buildings or spaces treated ................................... 20

IIIA 8.8.4 Withholding period (in days) for animal feedingstuffs ................................................ 20

IIIA 8.8.5 Waiting period before sowing or planting crop to be protected ................................. 20

IIIA 8.8.6 Waiting period between application and handling treated products ......................... 20

IIIA 8.8.7 Waiting period (in days) before sowing or planting succeeding crops ....................... 20

IIIA 8.9 Other/Special Studies ...................................................................................................... 20

IIIA 8.10 Estimation of Exposure Through Diet and Other Means ............................................ 21

IIIA 8.11 Summary and Evaluation of Residue Behaviour ......................................................... 22


National Assessment

Batavia

Registration Report

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Date: January 2019

Appendix 1: List of data submitted in support of the extension of use ............................................ 24

Appendix 2: Critical Uses – justification and GAP tables ................................................................. 26

Appendix 3: Pesticide Residue Intake Model (PRIMO) .................................................................... 26


National Assessment

Batavia

Registration Report

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Date: January 2019

IIIA 8 METABOLISM AND RESIDUES DATA

Regulatory Background

The plant protection product Batavia (15615 N) is authorised in the Netherlands for indoor use on various

edible and non-edible commodities. With the current application, the applicant seeks for registration of

minor indoor uses in: other leafy vegetables excluding witloof chicory (watercress, lamb’s lettuce, rocket,

sea lavender), endive, vegetables sprouts, baby leaf crops, leafy brassica, aromatic herbs, and plant

breeding crops and basic seed production. Since the intended indoor use in plant breeding crops and basic

seed production is not relevant for the section of residues and consumer safety, this intended use will not

be discussed in this document.

It is noted that for the current application for extension of authorisation for minor uses, the risk envelop

approach is applied. Therefore, data points that are covered by the main authorisation will not be

summarised again.


National Assessment

Batavia

Registration Report

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Date: January 2019

IIIA 8.1 Stability of Residues

The stability of residues is covered by the main authorisation.

Conclusion:

Residues of spirotetramat should be considered stable for at least 18 months in high-water, high starch

and high oil content matrices when analysed for the sum of spirotetramat and spirotetramat-enol.

Spirotetramat-ketohydroxy, spirotetramat-enol-Glc and spirotetramat-mono hydroxy stable for at least 18

months in high-water, high starch and high oil content matrices, and 5 and 12 months in orange juice,

prune and tomato past, respectively.

Concerning the stability of residues in sample extracts, the analytical procedure is routinely monitored by

performing concurrent recoveries with each sample set when conducting residue analysis on regular

samples.

Table 8.1.1- 1 Summary of storage stability of total spirotetramat residues

Compound Plant matrix Stability (max. period tested)

(days) Storage conditions

Spirotetramat, BYI08330-enol,

BYI08330-ketohydroxy,

BYI08330 monohydroxy,

BYI08330 enol-glucoside,

Total residue of spirotetramat

Tomato Fruit

Potato Tuber

Head lettuce

Climbing French bean

Almond nutmeat

Tomato Paste

718 ≤ -18°C

Orange juice

Prunes 147 ≤ -18°C

IIIA 8.2 Supplementary studies on metabolism in plants or livestock

The metabolism in plants and livestock is covered by the main authorisation.

It is noted that during the peer review , the residue definitions in plants were proposed as "sum of

spirotetramat and spirotetramat-enol, expressed as spirotetramat" and "sum of spirotetramat,

spirotetramat-enol, spirotetramat-enol-Glc, spirotetramat-ketohydroxy and spirotetramat-monohydroxy,

expressed as spirotetramat" for monitoring and risk assessment, respectively (EFSA, 2013). However, the

current residue definition for monitoring as set in Reg. (EC) No 396/2005 is "sum of spirotetramat,


expressed as spirotetramat". Therefore, the latter residue definition including the parent and four

metabolites is considered for monitoring and risk assessment in this document.

Likewise, the residue definitions for livestock differ between the peer review and Reg. (EC) No

396/2005. In the peer review, the residue definitions were set as "spirotetramat-enol expressed as

spirotetramat" and "sum of spirotetramat-enol and spirotetramat-enol-GA expressed as spirotetramat" for

monitoring and riskassessment, respectively. In Reg. (EC) No 396/2005, the residue definitions are

"spirotetramat, spirotetramat-enol and spirotetramat-enolglucuronide, expressed as spirotetramat" for

monitoring and risk assessment alike. Similarily to plants, the residue definitions according to Reg. (EC)

No 396/2005 are considered in the current document.


National Assessment

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Date: January 2019

IIIA 8.3 Supplementary residue trials (supervised field trials)

The critical uses applied for are summarised in Table 8.3-1.

Table 8.3-1: Summary of the critical GAPs for the proposed indoor uses of Batavia

Crop

Application Application rate per treatment

Method,

kind Number

Interval

(days) g as/hL

water

L/ha max. g as/ha

PHI

(days)

Other leafy vegetables

excluding witloof

chicory (watercress,

lamb’s lettuce, rocket,

sea lavender)

Spraying 2 14 7.5-37.5 200-1000 75 7

Endive Spraying 2 14 7.5-37.5 200-1000 75 7

Baby leaf crops Spraying 2 14 7.5-37.5 200-1000 75 7

Leafy brassica Spraying 2 14 7.5-37.5 200-1000 75 3

Aromatic herbs Spraying 2 14 7.5-37.5 200-1000 75 7

IIIA 8.3.1 Other leafy vegetables excluding witloof chicory (watercress, lamb’s lettuce,

rocket, sea lavender)

Table 8.3.1-1: Summary of the cGAP for the proposed indoor use of Batavia in other leafy vegetables

excluding witloof chicory (watercress, lamb’s lettuce, rocket, sea lavender)

Crop Country No. of

appli-

cations

Interval

(days)

Water rate

(L/ha)

Application

rate

(g a.s./ha)

PHI

(days)

Other leafy vegetables excluding

witloof chicory (watercress, lamb’s

lettuce, rocket, sea lavender)

NL 2 14 200-1000 75 7

Three studies investigating the magnitude of spirotetramat residues in lettuce are available that were

conducted in the growing seasons 2004 and 2005 under greenhouse conditions. The studies were already

evaluated in the DAR by Austria and by EFSA during the peer review of spirotetramat to support the

representative indoor use in lettuce according to the GAP 2 x 72 g/ha, interval 14 d, PHI 7 d (Austria,

2013; EFSA, 2013). The studies were considered acceptable and are therefore not summarised in detail

anymore in this document. Instead, only the summary tables of the supervised residue trials are presented

below for the sake of completeness. Residue levels were selected according to the residue definitions that

are currently in force (see IIIA 8.2). The slight difference in the application rate between the peer review

and the current application (72 g/ha cf. 75 g/ha) is considered to have a negligible impact on the residue

levels.

All trials were conducted in lettuce. According to SANCO/7525/VI/95 Rev. 9 (March 2011), trials on

open leaf varieties of lettuce can be extrapolated to watercresses, lamb’s lettuce, rocket, and sea

lavanders. It is noted that the latter crop falls under purslanes in Annex I of Reg. (EC) No 396/2005 and

therefore, the MRL of purslanes applied to sea lavender. The crops under consideration are all minor

crops in NEU; therefore, 4 trials are considered sufficient for evaluation. From the available trials, 10

trials were conducted on open leaf varieties and are considered for evaluation. Based upon these trials, an

MRL of 6.00 mg/kg is calculated. Existing MRLs of spirotetramat as established by Reg. (EU) No


National Assessment

Batavia

Registration Report

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Date: January 2019

2017/1016 in watercresses, lamb’s lettuce, rocket, and purslanes/sea lavanders are at 7.00 mg/kg; an MRL

exceendance is not expected.

Table 8.3.1-2: Summary of spirotetramat residues to support the use in other leafy vegetables excluding witloof

chicory (watercress, lamb’s lettuce, rocket, sea lavender)

Crop Region Individual trial results (mg/kg)

Mo: according to residue definition for

monitoring

RA: according to residue definition for risk

assessment

MRL

proposal

(mg/kg)

STMR

(mg/kg)

HR

(mg/kg)

Median

CF

Other leafy

vegetables

excluding

witloof chicory

(watercress,

lamb’s lettuce,

rocket, sea

lavender)

2 x 75 g/ha,

interval 14 d,

PHI 7 d

EU

indoor

Trials conducted in lettuce (open leaf varieties)

Mo/RA: 0.374, 0.387, 1.057, 1.296, 1.445, 1.642,

1.774, 1.958, 2.327, 3.442

6.00 1.54 3.44 -

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 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

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

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



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

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



GLP: yes

Deviations: no

Validity: yes


National Assessment

Batavia

Registration Report

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Date: January 2019

Report No.

Trial No

Location

Commodit

y/

Variety

Date of

1. Sowing or

planting

2. Flowering

3. Harvest

Application rate

per treatment Dates of

treatment(s)

or no. of

treatment

and last date

Growth

stage at

last

treatment

or date

Portion

analysed

Residues, expressed as spirotetramat (BYI 08330)

[mg/kg]

PHI

[days] Remarks

kg a.s./

ha

water

l/ha

kg

a.s./hl

BYI

08330

BYI

08330-

enol

BYI

08330

ketohy

droxy

BYI

08330

monoh

ydroxy

BYI

08330

enol-Glc

Total

Greenhouse trials

RA-2054/04

R 2004 0393/3

D-40764

Langenfeld,

Germany

Lettuce /

Alexandria

(Butter-

head

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

formulatio

n: 100 OD;

Closed leaf

variety

RA-2054/04

R 2004 0394/1

F-31790 St.

Jory, Southern

France

Lettuce /

Alexandria

(Butter-

head

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

formulatio

n: 100 OD;

Closed leaf

variety

RA-2054/04

R 2004 0396/8

D-42799

Leichlingen,

Germany

Lettuce /

Roderik

(Butter-

head

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

formulatio

n: 100 OD;

Closed leaf

variety

RA-2054/04

R 2004 0397/6

I-00050

Palidoro

Fiumicino, Italy

Lettuce /

Kereon

(Butter-

head

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

formulatio

n: 100 OD;

Closed leaf

variety

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

formulatio

n: 100 OD;

Open leaf

variety

RA-2054/04

R 2004 0399/2

E-08410

Bigues, Spain

Lettuce /

Batavia

(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

formulatio

n: 100 OD;

Open leaf

variety


National Assessment

Batavia

Registration Report

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Date: January 2019

Report No.

Trial No

Location

Commodit

y/

Variety

Date of

1. Sowing or

planting

2. Flowering

3. Harvest

Application rate


treatment(s)

or no. of

treatment

and last date

Growth

stage at

last

treatment

or date

Portion

analysed


[mg/kg]

PHI

[days] Remarks

kg a.s./

ha

water

l/ha

kg

a.s./hl

BYI

08330

BYI

08330-

enol

BYI

08330

ketohy

droxy

BYI

08330

monoh

ydroxy

BYI

08330

enol-Glc

Total

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

formulatio

n: 100 OD;

Open leaf

variety

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

formulatio

n: 100 OD;

Open leaf

variety

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

formulatio

n: 150 OD;

Open leaf

variety

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

formulatio

n: 150 OD;

Open leaf

variety

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

formulatio

n: 150

OD;

Closed leaf

variety


National Assessment

Batavia

Registration Report

of 26


Date: January 2019

Report No.

Trial No

Location

Commodit

y/

Variety

Date of

1. Sowing or

planting

2. Flowering

3. Harvest

Application rate


treatment(s)

or no. of

treatment

and last date

Growth

stage at

last

treatment

or date

Portion

analysed


[mg/kg]

PHI

[days] Remarks

kg a.s./

ha

water

l/ha

kg

a.s./hl

BYI

08330

BYI

08330-

enol

BYI

08330

ketohy

droxy

BYI

08330

monoh

ydroxy

BYI

08330

enol-Glc

Total

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

formulatio

n: 150 OD;

Open leaf

variety

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

formulatio

n: 150 OD;

Closed leaf

variety

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

formulatio

n: 150 OD;

Closed leaf

variety

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

formulatio

n: 150 OD;

Closed leaf

variety

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

formulatio

n: 150 OD;

Open leaf

variety

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

formulatio

n: 240 SC;

addition of

0.2% RME

500;

Closed leaf

variety


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Registration Report

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Date: January 2019

Report No.

Trial No

Location

Commodit

y/

Variety

Date of

1. Sowing or

planting

2. Flowering

3. Harvest

Application rate


treatment(s)

or no. of

treatment

and last date

Growth

stage at

last

treatment

or date

Portion

analysed


[mg/kg]

PHI

[days] Remarks

kg a.s./

ha

water

l/ha

kg

a.s./hl

BYI

08330

BYI

08330-

enol

BYI

08330

ketohy

droxy

BYI

08330

monoh

ydroxy

BYI

08330

enol-Glc

Total

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

formulatio

n: 240 SC;

addition of

0.2% RME

500;

Open leaf

variety

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

formulatio

n: 240 SC;

addition of

0.2% RME

500;

Open leaf

variety

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

formulatio

n: 240 SC;

addition of

0.2% RME

500;

Closed leaf

variety


National Assessment

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Date: January 2019

IIIA 8.3.2 Endive

Table 8.3.2-1: Summary of the cGAP for the proposed indoor use of Batavia in endive

Crop Country No. of

appli-

cations

Interval

(days)

Water rate

(L/ha)

Application

rate

(g a.s./ha)

PHI

(days)

Endive NL 2 14 200-1000 75 7

According to SANCO/7525/VI/95 Rev. 9 (March 2011), trials on open leaf varieties of lettuce can be

extrapolated to endives. Endive is considered as a minor crop in NEU; therefore, 4 trials are considered

sufficient for evaluation. The 10 trials that were conducted on open leaf varieties of lettuce (see IIIA

8.3.1) are considered acceptable for evaluation. Based upon these trials, an MRL of 6.00 mg/kg is

calculated. The existing MRL of spirotetramat as established by Reg. (EU) No 2017/1016 in endive is at

7.00 mg/kg; an MRL exceendance is not expected.

IIIA 8.3.3 Baby leaf crops

Table 8.3.3-1: Summary of the cGAP for the proposed indoor use of Batavia in baby leaf crops

Crop Country No. of

appli-

cations

Interval

(days)

Water rate

(L/ha)

Application

rate

(g a.s./ha)

PHI

(days)

Baby leaf crops NL 2 14 200-1000 75 7


extrapolated to baby leaf crops. Baby leaf crops are considered as a minor crop in NEU; therefore, 4 trials

are considered sufficient for evaluation. The 10 trials that were conducted on open leaf varieties of lettuce

(see IIIA 8.3.1) are considered acceptable for evaluation. Based upon these trials, an MRL of 6.00 mg/kg

is calculated. The existing MRL of spirotetramat as established by Reg. (EU) No 2017/1016 in baby leaf

crops is at 7.00 mg/kg; an MRL exceendance is not expected.

IIIA 8.3.4 Leafy brassica

Table 8.3.4-1: Summary of the cGAP for the proposed indoor use of Batavia in leafy brassica

Crop Country No. of

appli-

cations

Interval

(days)

Water rate

(L/ha)

Application

rate

(g a.s./ha)

PHI

(days)

Leafy brassica NL 2 14 200-1000 75 3

To support the indoor use in leafy brassica, two new studies in paksoi were submitted. These studies are

summarised below. The study summary table for both studies is shown in Table 8.3.4-4 and an overview

of residue levels and the derived endpoints are shown in Table 8.3.4-2.

Four indoor trials were conducted in paksoi to support the intended use in leafy brassica. Leafy brassica

are a minor crop in NEU, therefore 4 trials are required to support the intended use. Paksoi falls under


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Date: January 2019

Chinese cabbages/pe-tsai in Annex I of Reg. (EC) No 396/2005. According to SANCO/7525/VI/95 Rev.

9 (March 2011), trials on Chinese cabbages cannot be used to support the intended use in the whole

subgroup of leafy brassica. Therefore, no trials are available for evaluation of the intended use in the

whole subgroup of leafy brassica.

In agreement with the applicant, the intended use in leafy brassica was restricted to Chinese cabbage only.

Based upon the available trials in paksoi, an MRL of 4.00 mg/kg is calculated. The existing MRL of

spirotetramat as established by Reg. (EU) No 2017/1016 in Chinese cabbage is at 7.00 mg/kg; an MRL


Table 8.3.4-2: Summary of spirotetramat residues to support the use in leafy brassica

Crop Region Individual trial results (mg/kg)

Mo: according to residue definition for

monitoring

RA: according to residue definition for risk

assessment

MRL

proposal

(mg/kg)

STMR

(mg/kg)

HR

(mg/kg)

Median

CF

Leafy brassica

Chinese

cabbage

2 x 75 g/ha,

interval 14 d,

PHI 3 d

EU

indoor

Trials conducted in paksoi cannot be used to support

the intended use in leafy brassica. In agreement with

the applicant, the intended use was amended to

Chinese cabbage only.

Mo/RA: 2x 0.80, 1.4, 1.9

4.00 1.1 1.9 -

Reference: Determnination of the decline of residues of spirotetramat and its metabolites

in protected Paksoi after 2 applications with Movento in The Netherlands,

2012

Report/Doc. number: R-12-35-NL-01

Guideline(s): Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, section 8;

Appendix B of SANCO/7029/VI/95 rev. 5; Directive 91/414/EEC Annex II, part

A section 4 and Annex III, part A, section 5

GLP: yes

Deviations: no

Validity: yes

Materials & methods

The objective of the study is to determine the decline of the residues of spirotetramat and its metabolites

in protected paksoi in two trials in the Netherlands resulting from two applications of Movento. Movento

is an SC formulation containing 100 g/L spirotetramat as active substance. The test item is considered

adequate to support the intended uses of Batavia in leafy brassica. Each trials consisted of an untreated

and a treated plot. Two foliar applications at nominally 75 g a.s./ha were conducted on the treated plots

with an interval of 14 days. Both applications were performed between growth stages BBCH 44-47.

Specimens from treated plots were taken at -0 (sampling prior to last application), 0, 1, 3, and 7 days after

the last application for both trials. Specimens of control samples were taken at -0 and 3 days after the last

application. Specimens were frozen within 12 hours after sampling and kept below -18 °C during storage.

Paksoi specimens were analysed for spirotetramat and its metabolites spirotetramat-enol, spirotetramat-

ketohydroxy, spirotetramat-monohydroxy, and spirotetramat-enol-glucoside using the validated Bayer

Crop Science (BCS) LC-MS/MS method 01207. The LOQ of the method is 0.01 mg/kg for each analyte.

During the analysis of field samples, concurrent recoveries were determined.


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Date: January 2019

Results and discussion

The trials were conducted according to the intended GAP for leafy brassica (2 x 75 g a.s./ha, interval 14

d, PHI 3 d).

Samples were stored for maximally 3 months. This period is sufficiently covered by available storage

stability data.

The concurrent recoveries are shown in Table 8.3.4-3. Individual and overall recoveries, as well as the

RSD, were within the acceptable ranges. The analytical method is considered acceptable.

Table 8.3.4-3: Concurrent recoveries measured during the analysis of field samples.

Analyte Fortification level Single recoveries [%] Overall ± RSD [%]

Spirotetramat 0.01 99, 107 95 ± 9.0

0.10 103, 95

0.50 89

0.75 80

2.0 90, 95

Spirotetramat-enol 0.01 88, 92 90 ± 12

0.10 93, 91

0.50 77

0.75 73

2.0 102, 104

Spirotetramat-ketohydroxy 0.01 106, 89 94 ± 12

0.10 110, 95

0.50 83

0.75 83

Spirotetramat-monohydroxy 0.01 102, 96 92 ± 13

0.10 104, 97

0.50 78

0.75 77

Spirotetramat-enol-gulucoside 0.01 97, 90 87 ± 13

0.10 101, 86

0.50 75

0.75 72

No residues were measured in any control sample. Residue levels in paksoi resulting from the treatment

with Movento are shown in Table 8.3.4-5.

Reference: Determnination of the magnitude of the residues of spirotetramat and its

metabolites in protected Paksoi after 2 applications with Movento in The

Netherlands, 2012

Report/Doc. number: R-12-35-NL-02

Guideline(s): Directive 91/414/EEC Annex II, part A section 6 and Annex III, part A, section 8;

Appendix B of SANCO/7029/VI/95 rev. 5; Directive 91/414/EEC Annex II, part


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A section 4 and Annex III, part A, section 5

GLP: yes

Deviations: no

Validity: yes

Materials & methods

The objective of the study is to determine the decline of the residues of spirotetramat and its metabolites

in protected paksoi in two trials in the Netherlands resulting from two applications of Movento. Movento

is an SC formulation containing 100 g/L spirotetramat as active substance. The test item is considered

adequate to support the intended uses of Batavia in leafy brassica. Each trials consisted of an untreated

and a treated plot. Two foliar applications at nominally 75 g a.s./ha were conducted on the treated plots

with an interval of 14 days. Both applications were performed between growth stages BBCH 46-49.

Specimens from treated and untreated plots were taken 3 days after the last application for both trials.

Specimens were frozen within 12 hours after sampling and kept below -18 °C during storage.

Paksoi specimens were analysed for spirotetramat and its metabolites spirotetramat-enol, spirotetramat-

ketohydroxy, spirotetramat-monohydroxy, and spirotetramat-enol-glucoside using the validated Bayer

Crop Science (BCS) LC-MS/MS method 01207. The LOQ of the method is 0.01 mg/kg for each analyte.

During the analysis of field samples, concurrent recoveries were determined.

Results and discussion

The trials were conducted according to the intended GAP for leafy brassica (2 x 75 g a.s./ha, interval 14

d, PHI 3 d).

Samples were stored for maximally 2.5 months. This period is sufficiently covered by available storage

stability data.

The concurrent recoveries are shown in Table 8.3.4-4. Individual and overall recoveries, as well as the

available RSD values, were within the acceptable ranges. It is noted that for spirotetramat-ketohydroxy,

spirotetramat-monohydroxy, and spirotetramat-enol-glucoside, only two procedural recoveries were

determined and therefore, no RSD could be determnined. Although additional concurrent recoveries are

desirable, the analytical method is considered acceptable.

Table 8.3.4-4: Concurrent recoveries measured during the analysis of field samples.

Analyte Fortification level Single recoveries [%] Overall ± RSD [%]

Spirotetramat 0.01 101, 109 99 ± 8.1

0.10 91

0.50 94

Spirotetramat-enol 0.01 101, 101 97 ± 5.9

0.10 96

0.50 89

Spirotetramat-ketohydroxy 0.01 82 81

0.10 79

Spirotetramat-monohydroxy 0.01 93 92

0.10 91

Spirotetramat-enol-gulucoside 0.01 88 88


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Date: January 2019

0.10 88

No residues were measured in any control sample. Residue levels in paksoi resulting from the treatment

with Movento are shown in Table 8.3.4-5.


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Date: January 2019

Table 8.3.4-5: Overview of the available residue trials in paksoi following foliar treatment with spirotetramat

Report No.

Trial No

Location

Commodit

y/

Variety

Date of

1. Sowing or

planting

2. Flowering

3. Harvest

Application rate


treatment(s)

or no. of

treatment

and last date

Growth

stage at

last

treatment

or date

Portion

analysed


[mg/kg]

PHI

[days] Remarks

g a.s./

ha

water

l/ha

g

a.s./hl

BYI

08330

BYI

08330-

enol

BYI

08330

ketohy

droxy

BYI

08330

monoh

ydroxy

BYI

08330

enol-Glc

Total

Greenhouse trials

R12-35-NL-01,

R12-351-01,

2991 SE

Barendrecht,

NL

Paksoi, Joi

Choi

1. 22/02/12

2. –

3. –

75.40

74.89

498

495

-

-

12/03/12

26/03/12

44

46-47

Plant

without

roots

0.02

1.7

1.5

1.0

0.79

0.10

2.5

1.2

0.80

0.59

0.02

0.08

0.07

0.06

0.04

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

0.15

4.3

2.9

1.9

1.4

-0*

0

1

3

7

R12-35-NL-01,

R12-351-02,

2995 BJ

Heerjansdam,

NL

Paksoi, Joi

Choi

1. 21/02/12

2. –

3. –

73.89

75.60

488

500

-

-

12/03/12

26/03/12

44

47

Plant

without

roots

<0.01

0.88

0.81

0.59

0.36

0.01

1.6

1.1

0.73

0.52

<0.01

0.06

0.06

0.04

0.03

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

0.05

2.5

2.0

1.4

0.93

-0*

0

1

3

7

R12-35-NL-02,

R12-352-01,

3335 LG

Zwijndrecht,

NL

Paksoi, Joi

Choi

1. 04/09/12

2. –

3. –

76.6

76.6

507

507

-

-

14/09/12

28/09/12

46

48-49

Plant

without

roots

0.48 0.28 0.04 <0.01 <0.01 0.80 3

R12-35-NL-02,

R12-352-02,

Heerjansdam,

NL

Paksoi, Joi

Choi

1. 25/08/12

2. –

3. –

79.1

78.1

523

517

-

-

14/09/12

28/09/12

46

48-49

Plant

without

roots

0.48 0.29 0.03 <0.01 <0.01 0.80 3

* -0: sampling prior to last application


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Date: January 2019

IIIA 8.3.5 Aromatic herbs

Table 8.3.5-1: Summary of the cGAP for the proposed indoor use of Batavia in aromatic herbs

Crop Country No. of

appli-

cations

Interval

(days)

Water rate

(L/ha)

Application

rate

(g a.s./ha)

PHI

(days)

Aromatic herbs NL 2 14 200-1000 75 7


extrapolated to the whole subgroup (f) of herbs and edible flower. Due to a discrepancy between Annex I

of Reg. (EC) No 396/2005 and the Dutch list of uses, the subgroup (f) of herbs and edible flowers as

listed in Annex I only includes the aromatic herbs as listed in the Dutch list of uses. Therefore, an

application was made for aromatic herbs according to the Dutch list of uses. Herbs and edible

flower/aromatic herbs are considered as minor crops in NEU; therefore, 4 trials are considered sufficient

for evaluation. The 10 trials that were conducted on open leaf varieties of lettuce (see IIIA 8.3.1) are

considered acceptable for evaluation. Based upon these trials, an MRL of 6.00 mg/kg is calculated. The

existing MRL of spirotetramat as established by Reg. (EU) No 2017/1016 in herbs and edible

flowers/aromatic herbs is at 4.00 mg/kg; an MRL exceedance cannot be excluded. At the time point of

MRL setting (EFSA, 2011), the same data set was available as the one presented in this dossier. In the

Reasoned Opinion, however, a mistake was apparently made since the highest residue from the

greenhouse trials in open leaf varieties (3.442 mg/kg) was not considered in the Reasoned Opinion. There

are no obvious reasons why this value should be discarded from the data set. Therefore, the value is

considered within this application. As a consequence, the existing MRL is expected to be exceeded.

However, considering that 7 out of the 10 available trials were conducted with three applications instead

of the intended two, residue levels are rather overestimated. This is highlighted by the fact that the three

available trials conducted with two applications resulted in lower residue levels (0.74-1.057 mg/kg cf.

1.296-3.442 mg/kg for two and three applications, respectively). Based upon expert judgement, it is not

expected that the existing MRL will be exceeded if aromatic herbs are treated according to the intended

GAP.

IIIA 8.4 Supplementary Livestock Feeding Studies

Residues in livestock are not covered by the main authorisation.

Of the crops under consideration only kale, which falls under the leafy brassica, may be fed to livestock.

Since no supervised residue trials are available to support this use, the dietary burden cannot be

calculated. Of the uses recommended for authorisation, no crops are fed to livestock and therefore the

aspect of residues in livestock does not need to be addressed.

IIIA 8.5 Supplementary Studies on Industrial Processing and/or Household

Preparation

The aspect of residues in processed commodities is covered by the main authorization.

IIIA 8.6 Supplementary Studies for Residues in Representative Succeeding Crops

The aspect of residues in succeeding crops is covered by the main authorisation.


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IIIA 8.7 Proposed Residue Definition and Maximum Residue Levels

IIIA 8.7.1 Proposed residue definition

The proposed residue definitions are covered by the main authorisation.

It is noted that during the peer review , the residue definitions in plants were proposed as "sum of

spirotetramat and spirotetramat-enol, expressed as spirotetramat" and "sum of spirotetramat,


expressed as spirotetramat" for monitoring and risk assessment, respectively (EFSA, 2013). However, the

current residue definition for monitoring as set in Reg. (EC) No 396/2005 is "sum of spirotetramat,


expressed as spirotetramat". Therefore, the latter residue definition including the parent and four

metabolites is considered for monitoring and risk assessment in this document.

Likewise, the residue definitions for livestock differ between the peer review and Reg. (EC) No

396/2005. In the peer review, the residue definitions were set as "spirotetramat-enol expressed as

spirotetramat" and "sum of spirotetramat-enol and spirotetramat-enol-GA expressed as spirotetramat" for

monitoring and riskassessment, respectively. In Reg. (EC) No 396/2005, the residue definitions are

"spirotetramat, spirotetramat-enol and spirotetramat-enolglucuronide, expressed as spirotetramat" for

monitoring and risk assessment alike. Similarily to plants, the residue definitions according to Reg. (EC)

No 396/2005 are considered in the current document.

IIIA 8.7.2 Proposed maximum residue levels (MRLs)

MRLs are set at European Level and the review is performed by EFSA. The EU MRLs and calculated

MRLs for the crops considered in this dossier are summarised in Table 8.7.2-1. An MRL exceedance is

not expected for the intended indoor uses in other leafy vegetables excluding witloof chicory (watercress,

lamb’s lettuce, rocket, sea lavender), endive, and baby leaf crops. In contrast, the MRL for herbs and

edible flowers/aromatic herbs is expected to be exceeded..No trials are available for evaluation of the

intended use in the whole subgroup of leafy brassica.

In agreement with the applicant, the intended use in leafy brassica was restricted to Chinese cabbage only

Table 8.7.2-1: EU MRLs set for the uses of spirotetramat

Crop STMR

(mg/kg)

HR

(mg/kg)

OECD

calculator

MRL

(mg/kg)

EU MRL

(mg/kg)

MRL com-

pliance

Other leafy vegetables

excluding witloof

chicory (watercress,

lamb’s lettuce, rocket,

sea lavender)

1.54 3.44 6.0 7.0 Y

Endive 1.54 3.44 6.0 7.0 Y

Baby leaf crops 1.54 3.44 6.0 7.0 Y

Leafy brassica 1.1 1.9 4.0 7.0 Y


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Crop STMR

(mg/kg)

HR

(mg/kg)

OECD

calculator

MRL

(mg/kg)

EU MRL

(mg/kg)

MRL com-

pliance

Chinese cabbage1

Whole subgroup of

herbs and edible

flowers/ aromatic herbs

1.54 3.44 6.0 4.0 Y2

1 In agreement with the applicant, the intended use in leafy brassica was amended to Chinese cabbage in

the course of the evaluation. 2 Based upon expert judgement, it is not expected that MRLs will be exceeded. It is referred to Section

IIIA 8.3.5 for more details.

IIIA 8.8 Proposed Pre-Harvest Intervals, Re-Entry or Withholding Periods

IIIA 8.8.1 Pre-harvest interval (in days) for each relevant crop

The PHI is specified in the GAP enclosed to this application.

IIIA 8.8.2 Re-entry period (in days) for livestock, to areas to be grazed

No re-entry or withholding periods are proposed.

IIIA 8.8.3 Re-entry period for man to crops, buildings or spaces treated

Not applicable.

IIIA 8.8.4 Withholding period (in days) for animal feedingstuffs

Not applicable.

IIIA 8.8.5 Waiting period before sowing or planting crop to be protected

Not applicable.

IIIA 8.8.6 Waiting period between application and handling treated products

Not applicable, as residues do not present a risk.

IIIA 8.8.7 Waiting period (in days) before sowing or planting succeeding crops

Not applicable, as no residues are expected in succeeding crops.

IIIA 8.9 Other/Special Studies

Other special studies are not needed.


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IIIA 8.10 Estimation of Exposure Through Diet and Other Means

The ADI and ARfD values for spirotetramat are summarised in the table below.

Active substance End-Point Value

(mg/kg bw/day)

Study Safety factor Reference

Spirotetramat Acceptable

Daily Intake

(ADI)

0.05 Based on 1-year dog

study

100 EFSA, 2013

Acute

Reference

Dose (ARfD)

1 Based on acute

neurotoxicity rat

study

100 EFSA, 2013

In order to evaluate the potential chronic and acute exposure to spirotetramat residues through the diet,

the intakes were estimated using the EFSA PRIMo (revision 2). This exposure assessment model contains

the relevant European food consumption data for different sub-groups of the EU population. For the

calculation of chronic and acute exposure, use is made of the input values for commodities from the latest

EFSA opinion (EFSA Journal 2017;15(1):4684). These input values cover the intended uses of Batavia

except for herbs and edible flowers. Since this use is currently not recommended for authorisation due to

an MRL exceedance, it is not considered necessary to perform a new consumer risk assessment. Before

the use in herbs and edible flowers may be authorised, an MRL application needs to be submitted in

which the consumer risk assessment will be conducted based on the available data.

Long-term or acute consumer intake concerns were not identified by EFSA for any of the European diets

incorporated in the EFSA PRIMo. The highest chronic intake accounted for 37% of the ADI (WHO

cluster B) and the highest acute exposure for 48% of the ARfD for escarole (German toddler) which is

also a crop under consideration in this dossier.


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IIIA 8.11 Summary and Evaluation of Residue Behaviour

The plant protection product Batavia (15615 N) is authorised in the Netherlands for indoor use on various

edible and non-edible commodities. With the current application, the applicant seeks for registration of

minor indoor uses in: other leafy vegetables excluding witloof chicory (watercress, lamb’s lettuce, rocket,

sea lavender), endive, vegetables sprouts, baby leaf crops, leafy brassica, aromatic herbs, and plant

breeding crops and basic seed production. Since the intended indoor use in plant breeding crops and basic

seed production is not relevant for the section of residues and consumer safety, this intended use was not

discussed in this document.

The majority of information and data were already evaluated in the main authorisation. The metabolism

of spirotetramat in plants, animals, rotational crops, and processed commodities is covered by the main

authorisation. Likewise, storage stability was sufficiently demonstrated before.

Other leafy vegetables excluding witloof chicory (watercresses, lamb’s lettuce, rocket, sea

lavender); endives; baby leaf crops; aromatic herbs

cGAP-NL: 2 x 75 g a.s./ha, interval 14 d, PHI 7 d

Three studies investigating the magnitude of spirotetramat residues in lettuce are available that were

already evaluated in the DAR by Austria and by EFSA during the peer review of spirotetramat to support

the representative indoor use in lettuce according to the GAP 2 x 72 g/ha, interval 14 d, PHI 7 d (Austria,

2013; EFSA, 2013). The studies were considered acceptable and were therefore not summarised in detail

anymore within this application. Residue levels were selected according to the residue definitions that are

currently in force. The slight difference in the application rate between the peer review and the current

application (72 g/ha cf. 75 g/ha) is considered to have a negligible impact on the residue levels.


extrapolated to watercresses, lamb’s lettuce, rocket, sea lavender, endives, baby leaf crops, and the whole

subgroup of herbs and edible flowers. It is noted that: (i) sea lavender falls under purslanes in Annex I of

Reg. (EC) No 396/2005 and therefore, the MRL of purslanes applied to sea lavender; and (ii) due to a

discrepancy between Annex I of Reg. (EC) No 396/2005 and the Dutch list of uses, the subgroup of herbs

and edible flowers as listed in Annex I only includes the aromatic herbs as listed in the Dutch list of uses.

Therefore, an application was made for aromatic herbs according to the Dutch list of uses.

Watercresses, lamb’s lettuce, rocket, sea lavender, endives, baby leaf crops, and the whole subgroup of

herbs and edible flowers are all minor crops in NEU; therefore, 4 trials are considered sufficient for

evaluation. From the available trials, 10 trials were conducted on open leaf varieties and are considered

for evaluation. Based upon these trials, an MRL of 6.00 mg/kg is calculated. Existing MRLs of

spirotetramat as established by Reg. (EU) No 2017/1016 in watercresses, lamb’s lettuce, rocket, and

purslanes/sea lavanders, endives, and baby leaf crops are at 7.00 mg/kg; an MRL exceendance is not

expected. In contrast, the existing MRL of spirotetramat in herbs and edible flowers is at 4.0 mg/kg; i.e.

an MRL exceedance cannot be excluded. At the time point of MRL setting (EFSA, 2011), the same data

set was available as the one presented in this dossier. In the Reasoned Opinion, however, a mistake was

apparently made since the highest residue from the greenhouse trials in open leaf varieties (3.442 mg/kg)

was not considered in the Reasoned Opinion. There are no obvious reasons why this value should be

discarded from the data set. Therefore, the value is considered within this application. As a consequence,

the existing MRL is expected to be exceeded. However, considering that 7 out of the 10 available trials

were conducted with three applications instead of the intended two, residue levels are rather

overestimated. This is highlighted by the fact that the three available trials conducted with two

applications resulted in lower residue levels (0.74-1.057 mg/kg cf. 1.296-3.442 mg/kg for two and three

applications, respectively). Based upon expert judgement, it is not expected that the existing MRL will be

exceeded if aromatic herbs are treated according to the intended GAP.

Leafy brassica


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cGAP-NL: 2 x 75 g a.s./ha, interval 14 d, PHI 3 d

To support the indoor use in leafy brassica, two new studies with, in total, four trials in paksoi were

submitted. Paksoi falls under Chinese cabbages/pe-tsai in Annex I of Reg. (EC) No 396/2005. According

to SANCO/7525/VI/95 Rev. 9 (March 2011), trials on Chinese cabbages cannot be used to support the

intended use in the whole subgroup of leafy brassica. Therefore, no trials are available for evaluation. The

intended use in leafy brassica is not recommended for authorisation.

In agreement with the applicant, the intended use in leafy brassica was restricted to Chinese cabbage only.

Based upon the available trials in paksoi, an MRL of 4.00 mg/kg is calculated. The existing MRL of

spirotetramat as established by Reg. (EU) No 2017/1016 in Chinese cabbage is at 7.00 mg/kg; an MRL


Of the crops under consideration only kale, which falls under the leafy brassica, may be fed to livestock.

Since the intended use in leafy brassica was restricted to Chinese cabbage only during the course of the

evaluation, none of the intended uses are fed to livestock and therefore the aspect of residues in livestock

does not need to be addressed.

Residues in succeeding crops are covered by the main authorisation.

The dietary risk estimated for a short-term or a long-term consumption of residues of spirotetramat was

estimated using the EFSA PRIMo model rev. 2. No acute or chronic risk to the consumer was identified.


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Appendix 1: List of data submitted in support of the extension of use

Annex

point

Year Title

Source (where different

from company)

Company name,

Report No., Date,

GLP/GEP status

(where relevant)

published or not

Study

relied

on

Owner Application

number of

first

submission

Date of

first

submission

(Document)

KCP

8.3/01

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

Report No.: RA-2170/05

Edition Number: M-

272108-01-1

Date: 2006-05-31

GLP/GEP: Yes,

unpublished

Yes Bayer 20071148 TG

(Movento)

2009-10-30

KCP

8.3/02



in/on lettuce after


(100 OD) in the

greenhouse in Germany,

Southern France, Italy

and Spain

Bayer


Edition Number: M-

262616-01-1

Date: 2005-12-15

GLP/GEP: Yes,

unpublished


(Movento)

2009-10-30


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Annex

point

Year Title

Source (where different

from company)

Company name,

Report No., Date,

GLP/GEP status

(where relevant)

published or not

Study

relied

on

Owner Application

number of

first

submission

Date of

first

submission

(Document)

KCP

8.3/03



in/on lettuce after


(240 SC) in the

greenhosue in Germany,

Italy and Spain

Bayer


Edition Number: M-

261625-01-1

Date: 2005-11-15

GLP/GEP: Yes,

unpublished


(Movento)

2009-10-30

KCP

8.3/04


magnitude of residues of

spirotetramat and its

metabolites in protected

Paksoi after 2 applications

with Movento in the

Netherlands, 2012

Final Report R12-35-NL-

02

de Breedelaar BV

Date: 28-02-2013

GLP/GEP: Yes,

unpublished

Yes Fonds

Kleine

Toepassi

ngen

Batavia

20181727

NLKUG

-

KCP

8.3/05


decline of the residues of

spirotetramat and its

metabolites in protected

Paksoi after 2 applications

with Movento in the

Netherlands, 2012

Final Report R12-35-NL-

01

de Breedelaar BV

Date: 24-09-2012

GLP/GEP: Yes,

unpublished

Yes Fonds

Kleine

Toepassi

ngen

Batavia

20181727

NLKUG

-


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Appendix 2: Critical Uses – justification and GAP tables

The critical uses for the risk envelope are indicated in the relevant parts of the risk assessment in this

section.

Appendix 3: Pesticide Residue Intake Model (PRIMO)

No new consumer risk assessment was performed since this is covered by the latest EFSA reasoned

opinion (EFSA, 2017).

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