HET COLLEGE VOOR DE TOELATING VAN ......HET COLLEGE BESLUIT tot uitbreiding van de toelating van bovenstaand middel. Alle bijlagen, waaronder registratierapport deel A en deel B, vormen

Part A

National Assessment – The Netherlands

CLOSER Registration Report Central Zone

Page 1 of 94

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT

Op 30 april 2015 is van

Dow AgroSciences B.V.

Sneeuwbeslaan 20 bus 10

B-2610 WILRIJK

Belgium

een aanvraag tot uitbreiding van een toelating van een gewasbeschermingsmiddel (NL is CMS)

ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening)

voor het gewasbeschermingsmiddel

CLOSER

op basis van de werkzame stof sulfoxaflor. Nederland is in deze een betrokken lidstaat, als bedoeld in

artikel 36, tweede lid; de beoordelend lidstaat is Ierland.

HET COLLEGE BESLUIT tot uitbreiding van de toelating van bovenstaand middel.

Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel van

dit besluit.

1.1 Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor

de toelating is verleend.

1.2 Gebruik

Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en zonder

enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.

1.3 Classificatie en etikettering

Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende

aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden

vermeld:

� De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder “verpakkingsinformatie”

in bijlage I.

Part A



Page 2 of 94

� Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A

van het registratierapport, Appendix I.

� Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

� De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de

voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2 van

deel A van het registratierapport.

1.4 Aflever- en opgebruiktermijn (respijtperiode)

Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op de

verpakking te worden aangebracht. De te hanteren w-coderingen en aflever- en opgebruiktermijnen

voor oude verpakkingen staan vermeld onder “toelatingsinformatie” in bijlage I.

2. WETTELIJKE GRONDSLAG

Besluit artikel 28 en artikel 36, derde lid, van de Verordening (EG)

1107/2009

Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009

Gebruikt toetsingskader Bgb en Rgb d.d. 16 december 2011 en Evaluation Manual Zonaal

2.0

3. BEOORDELINGEN

3.1 Fysische en chemische eigenschappen

De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en

ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn

bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het

middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar

geacht.

3.2 Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die

vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd

gebruik.

3.3 Risico voor de mens

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen

onaanvaardbaar risico voor de mens verwacht.

3.4 Risico voor het milieu

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen

onaanvaardbaar risico voor het milieu verwacht.

3.5 Werkzaamheid

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het

werkzaam is.

Voor nadere onderbouwing van de beoordelingen verwijzen wij u naar deel A en B van het Registration

Report als toegevoegd aan de bijlagen van dit besluit overeenkomstig Besluit beleidsregel bekendmaken

delen A en B van het Registration Report.

Part A



Page 3 of 94

Bezwaarmogelijkheid

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de

Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes

weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College

voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE.

Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift

opengesteld.

Ede, 5 april 2019

Het College voor de toelating van

gewasbeschermingsmiddelen en biociden,

voor deze:

de voorzitter,

Ir. J.F. de Leeuw

Part A



Page 4 of 94

BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

2.1 Aanvraaginformatie

Aanvraagnummer: 20140290 NLWTG

Type aanvraag: aanvraag tot uitbreiding van toelating

gewasbeschermingsmiddel (NL=CMS)

Middelnaam: CLOSER

Verzenddatum aanvraag: 3 maart 2014

Formele registratiedatum: * 16 juni 2015

Datum in behandeling name: 20 oktober 2017

Datum compliance check: n.v.t.

* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.

2.2 Stofinformatie

Werkzame stof Gehalte

Sulfoxaflor 120 g/L

• De stof is per 18 augustus 2015 goedgekeurd onder Verordening (EC) 1107/2009

(Uitvoeringsverordening (EU) 2015/1295 d.d. 27 juli 2015). De goedkeuring van deze werkzame

stof expireert op 18 augustus 2025.

2.3 Toelatingsinformatie

Toelatingsnummer: 15631 N

Expiratiedatum: 18 augustus 2026

Afgeleide parallel of origineel: Uitbreiding

Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel

Gebruikers: Professioneel

W-coderingen en aflever- en opgebruiktermijnen:

� W-codering professioneel gebruik: W1

� Vorige w-codering professioneel gebruik: -

� Aflevertermijn professioneel gebruik: Niet van toepassing

� Opgebruiktermijn professioneel gebruik: Niet van toepassing

2.4 Verpakkingsinformatie

Aard van het preparaat:

Suspensie concentraat

Part A



Page 5 of 94

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE II Etikettering van het middel CLOSER

Professioneel gebruik

de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:

-

Pictogram GHS09

Signaalwoord -

Gevarenaanduidingen H411 Giftig voor in het water levende organismen, met langdurige

gevolgen.

Voorzorgsmaatregelen P391 Gelekte/gemorste stof opruimen.

P501 Inhoud/verpakking afvoeren naar ....

SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water

verontreinigt.

Aanvullende

etiketelementen

EUH208 Bevat 1,2-benzisothiazolin-3-on. Kan een allergische

reactie veroorzaken.

EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke

gezondheid en het milieu te voorkomen.

Kinderveilige sluiting verplicht Niet van toepassing

Voelbare gevaarsaanduiding verplicht Niet van toepassing

Part A



Page 6 of 94

REGISTRATION REPORT

Part A

Risk Management

Product name

Product code

CLOSER

GF-2626, SC

Active Substance Sulfoxaflor, 120 g/L

Central Zone Zonal Rapporteur Member State: Ireland

NATIONAL ASSESSMENT - NL

Applicant DOW AGROSCIENCES

Date March 2019

Evaluator Ctgb, NL

Part A



Page 7 of 94

Table of content

Part A – Risk Management ............................................................................................................. 8

1 Details of the application ......................................................................................................... 8

1.1 Application background .................................................................................................. 8

1.2 EU Active Approval ........................................................................................................ 8

1.3 Regulatory approach ....................................................................................................... 8

1.4 Data protection claims ..................................................................................................... 8

1.5 Letters of access .............................................................................................................. 8

2 Details of the authorisation ..................................................................................................... 9

2.1 Product identity ............................................................................................................... 9

2.2 Classification and labelling ............................................................................................. 9

2.2.1 Classification and labelling under directive 99/45/EC ............ Fout! Bladwijzer niet

gedefinieerd.

2.2.2 R and S phrases under Directive 2003/82/EC (Annex IV and V) .. Fout! Bladwijzer

niet gedefinieerd.

Risk Phrases ...................................................................... Fout! Bladwijzer niet gedefinieerd.

Safety Phrases ................................................................... Fout! Bladwijzer niet gedefinieerd.

To avoid risks to man and the environment, comply with the instructions for use. ........ Fout!

Bladwijzer niet gedefinieerd.

2.2.3 Other phrases ................................................... Fout! Bladwijzer niet gedefinieerd.

2.3 Product uses ................................................................................................................... 10

3 Risk management .................................................................................................................. 11

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform principles ................................................................................................................................... 11

3.1.1 Physical and chemical properties ............................................................................ 11

3.1.2 Method of analysis .................................................................................................. 11

3.1.3 Mammalian Toxicology .......................................................................................... 12

3.1.4 Residues and Consumer Exposure .......................................................................... 13

3.1.5 Environmental fate and behaviour .......................................................................... 16

3.1.6 Ecotoxicology .......................................................................................................... 18

3.1.7 Efficacy ................................................................................................................... 28

3.2 Conclusions ................................................................................................................... 31

3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation ................................................... 31

Appendix 1 Copy of the product authorisation ................... Fout! Bladwijzer niet gedefinieerd.

Appendix 2 Copy of the product label ....................................................................................... 32

Appendix 3 Letter of Access ...................................................................................................... 36

Part A



Page 8 of 94

Part A – Risk Management

1 Details of the application

1.1 Application background

This application was submitted by Dow AgroSciences in April 2015. The application is for approval of the representative formulation CLOSER, a suspension concentrate (SC) containing 120 g/L of sulfoxaflor active substance for use as an insecticide in ornamentals, legumes, brassicas, potato and pome and stone fruits. Note:

At the request of the applicant, the number of uses in potatoes was changed during the

evaluation. The number of uses was changed from two uses to one use. The consequence of

this change has been evaluated for each aspect and only when necessary (the need for PPE /

restrictions / conclusions) changes were made.

1.2 EU Active Approval

• The substance is approved per August 18, 2015, according to Commission Implementing Regulation (EU) 2015/1295, d.d. July 27, 2015, with expiry date August 18, 2025.

• RMS: IE. • EFSA-conclusion: EFSA Journal 2014;12(5):3692, d.d. 11 March 2015. • Review report: SANTE/10665/2015 rev 2, d.d. 29 Mei 2015.

1.3 Regulatory approach

To obtain approval the product CLOSER must meet the conditions of EU Active approval and be supported by dossiers satisfying the requirements of Commission Regulation (EU) 545/2011, with an assessment to Uniform Principles, using EU agreed end-points

1.4 Data protection claims

Data protection is claimed for all studies used in supporting the registration of CLOSER.

1.5 Letters of access

Not necessary for the applications. Dow AgroSciences are the sole producer of sulfoxaflor technical and this application refers to the same technical source as has been assessed during the EU active approval process.

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015R1295

http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/3692.pdf

Part A



Page 9 of 94

2 Details of the authorisation

2.1 Product identity

Product Name CLOSER (GF-2626)

Authorisation Number (for re-registration)

15631 N

Function Insecticide

Applicant Dow AgroSciences

Composition 120 g/L pure Sulfoxaflor

Formulation type Suspension concentrate [Code: SC]

Packaging 0,25-20 L PET and HDPE bottles.

2.2 Classification and labelling according to Regulation (EC) 1272/2008

The identity of all substances in the mixture that contribute to the classification of the mixture *: - Pictogram: GHS09 Signal word: - H-statements: H411 Toxic to aquatic life with long lasting effects. P-statements: P391 Collect spillage. P501 Dispose of contents/container to .... Supplemental Hazard information:

EUH208 Contains 1,2-benzisothiazolin-3-one. May produce an allergic reaction.

EUH401 To avoid risks to human health and the environment, comply with the instructions for use.

SP1 Do not contaminate water with the product or its container.

Child-resistant fastening obligatory? not applicable Tactile warning of danger obligatory? not applicable

Explanation: Pictogram: - H-statements: - P-statements: P-statements were proposed by the applicant and are

accepted. Other: -

* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)

Part A



Page 10 of 94

2.3 Product uses

Note:

At the request of the applicant, the number of uses in potatoes was changed during the evaluation. The number of uses was changed

from two uses to one use. The consequence of this change has been evaluated for each aspect and only when necessary (the need for PPE

/ restrictions / conclusions) changes were made.

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation F

G

or

I

Pests or Group of

pests controlled Application Application rate per treatment PHI

(days)

Remarks: a) max. no. of applications per crop and

season b) Maximum product rate per season

c) additional remarks

Method / Kind

Timing / Growth stage of crop & season

Number / (min. Interval between applications)

L product / ha

kg as/ha Water L/ha min / max

6 NL Potato F Aphids Macrosiphum

euphorbiae,

Aphis nasturtii,

Myzus persicae,

Aphis fabae

Ground applied foliar spray, broadcast

BBCH 20-95 May-Aug

1 0.2 0.024 200-600 400 7 a) 1 b) 0.2 l/ha

Minor uses

2 NL Broccoli, Heading Cabbage, Brussels sprouts, Chinese cabbage

F Aphid Brevicoryne brassicae

Ground applied foliar spray, broadcast

BBCH 20-49 Apr-Sep

1 0.2 0.024 200-1000 7 a) 1 b) 0.2 l/ha

Part B Section 6 Core assessment

GF-2626

Registration Report – Central Zone Page 11 of 94

3 Risk management

3.1 Reasoned statement of the overall conclusions taken in accordance with the

Uniform principles

3.1.1 Physical and chemical properties

All the chemical properties were already evaluated in support of the Annex I inclusion of the active substance sulfoxaflor under regulation 91/414/EC.

CLOSER is a tan liquid with a mild odour. It does not possess any explosive or oxidizing properties. The formulation is considered not to be flammable or have an self-heating properties as the flash-point is >100°C and the auto-flammability is 380°C. The pH of a 1% dilution is between 3.81-4.21. However the pH of the neat formulation is not provided. The kinematic viscosity at 40°C is 135 mm2/s with no H304 classified components present. The density of the formulation is 1.0572 g/mL. The technical properties are acceptable to the intended use of the SC-formulation. Accelerated stability data after 2 weeks at 54 °C and 8 weeks 40°C of storage and ambient stability after 1 year of storage in HDPE and PET indicated stability and performance properties are preserved.

Additionally, a 2 year shelf-life study in HDPE and PET have been provided. The results show acceptable values after storage and therefore a 2 year shelf-life at ambient temperature in the packaging HDPE and PET can be granted.

Implications for labelling: None

Compatibility of mixtures: Not intended to be used in tank mixes Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable. Nature and characteristics of the protective clothing and equipment: Information regarding the required protective clothing and equipment for the safe handling of loser has been provided and is considered to be acceptable.

3.1.2 Method of analysis

3.1.2.1 Analytical method for the formulation

The analytical method for the determination of the active substance content in the formulation has already been evaluated at EU-level and found to be acceptable.

There are no relevant impurities in technical sulfoxaflor and they cannot be formed during manufacturing or storage of the formulation and therefore no analytical methods are required for the determination of the relevant impurities.


GF-2626


No CIPAC method is available for the active substance in an SC-formulation.

3.1.2.2 Analytical method for the residues

Analytical methods for the determination of the active substance and its metabolites in plant and animal matrices, soil, water and air are active substance data and were provided in the EU review of sulfoxaflor and were considered adequate (EFSA Scientific Report (2014); 12(5):3692).

The analytical method for the determination of residues of sulfoxaflor and its metabolites X11719474, X11579457 and X11519540 in surface water is compliant with Dutch national requirements (LOQ ≤ 0.1 µg/L for sulfoxaflor and its metabolite X11719474)

3.1.3 Mammalian Toxicology

3.1.3.1 Acute Toxicity

Acute toxicity studies have not been conducted on CLOSER on the basis of animal welfare.

It is possible to bridge from a similar formulation, GF-2032, which is a suspension

concentrate (SC) containing 240 g/L sulfoxaflor. The nominal compositions of CLOSER and

GF-2032 could be found in part C.

The nominal compositions of CLOSER and GF-2032 are considered similar enough to allow

GF-2032 acute toxicity data to be used as a surrogate in the absence of CLOSER.

GF-2032 exhibited low acute oral and dermal toxicity in the male and female rat with LD50 values > 5000 mg/kg bw. GF-2032 exhibited low acute inhalation toxicity in the male and female rat with an LC50 value > 2.21 mg/L. Skin and eye irritation studies in the NZW rabbit showed minimal to slight irritation and all effects resolved by 72 hours. No skin sensitization potential was evident in a mouse local lymph node assay.

3.1.3.2 Operator Exposure

Exposure of operators to sulfoxaflor from applications of CLOSER on brassicas, potatoes, and ornamentals have been evaluated using the Dutch EUROPOEM operator exposure model and do not present a risk to the unprotected operator (77% of the AOEL).

3.1.3.3 Bystander Exposure

Applications of GF-2626 for intended uses may potentially result in brief exposure of bystanders (incidental and residential) to diluted, water-based spray drift, but the extent of exposure will be significantly less than the AOEL (<3%) and therefore do not present a risk to human health.

3.1.3.4 Worker Exposer

The estimated systemic exposure to sulfoxaflor from re-entry to crops of intended uses immediately after spray dry, without wearing any personal protective clothing, is 77% of the AOEL for sulfoxaflor.


GF-2626


Therefore, re-entry tasks can be conducted without any adverse effects to the unprotected worker.

3.1.4 Residues and Consumer Exposure

3.1.4.1 Residues

The Draft Assessment Report (DAR) for sulfoxaflor that was produced as part of the process for EU Approval and the EFSA Conclusion on Pesticide Peer Review and associated MRL Application (EFSA Journal 2014;12(5):3692) were referenced as sources of information and previous evaluations of residue data supporting the proposed uses of GF-2626. In addition, a number of supplementary residues trials data have been presented, in the RR (zRMS Ireland) supporting the proposed GAPs.

Fruiting vegetables (Aubergine (incl. pepinos), Pepper (incl. Chili pepper), Tomato):

CGAP (indoor): BBCH 20-87; 1-2xs; interval 7d 24-48 g a.s. /ha PHI=1d

Eight trials were conducted on tomatoes for the indoor use according to the proposed GAP with one application of approximately 48 g a.s. /ha. Residues of sulfoxaflor at harvest (nominal 1-day PHI) were 2x <0.01; 2x 0.01; 0.012; 0.018; 0.052; 0.058 mg/kg. The residues of the metabolite X11719474 were below the LOQ in all corresponding samples. On the basis of the data an MRL of 0.1 mg/kg is calculated. The current EU MRL for tomatoes and aubergines is set at 0.3 mg/kg. The intended use for (tomatoes, aubergine and pepinos) is covered by the current EU MRL.

Eight trials were conducted on peppers for the indoor use according to the proposed GAP with one application of approximately 48 g a.s. /ha. Residues of sulfoxaflor at harvest (nominal 1-day PHI) were 3x 0.017; 2x 0.020; 0.021; 2x 0.035 mg/kg. The residues of the metabolite X11719474 were below the LOQ in all corresponding samples. On the basis of the data an MRL of 0.07 mg/kg is calculated. The current EU MRL for pepper (including chili pepper) is set at 0.4 mg/kg. The intended use for (pepper and chili pepper) is covered by the current EU MRL.

Flowering brassica (Broccoli, Cauliflower):

cGAP (outdoor): BBCH 20-49; 1x 24 g a.s. /ha PHI=7d

Twelve trials are available for the proposed use on flowering brassicas (six broccolis and six cauliflowers). Trials were conducted according to the proposed GAP with one application of approximately 24 g a.s. /ha. Sufficient trials are available for the major crops broccoli and cauliflower which eight trials are required to fulfil the GAP requirement. Residues of sulfoxaflor at harvest (nominal 7-day PHI) were 9 x <0.01, 0.02, 0.028, 0.077 mg/kg. The residues of the metabolite X11719474 were below the LOQ in all corresponding samples. Based on the residue results an MRL of 0.1 mg/kg is calculated for flowering brassica. The current EU MRL for broccoli is set at 3.0 mg/kg and the current EU MRL for cauliflower is 0.04 mg/kg. The calculated MRL exceeds thus the current EU MRL for cauliflower. According to zRMS Ireland, an import tolerance application is ongoing that proposes an MRL


GF-2626


of 0.1 mg/kg for cauliflower. The use on cauliflower cannot be supported currently. However, the use on broccoli is covered by the current EU MRL.

Head brassica (Brussels sprouts, head cabbage):

cGAP (outdoor): BBCH 20-49; 1x24 g a.s. /ha PHI=7d

For the use on Brussels sprout, six trials are available in the RR. Trials were conducted according to the proposed GAP. Residues of sulfoxaflor and the metabolite X11719474 at harvest (nominal 7-day PHI) were all below the LOQ. Since Brussel sprouts are major crops eight trials are required. However, as all residues of the six trials were at LOQ, reduced number of trials are acceptable and hence sufficient trials are available to support the GAP. On the basis of the residue data from the trials an MRL of 0.01* mg/kg is calculated using the OECD calculator. The current EU MRL at the LOQ of 0.01 mg/kg for Brussels sprouts will not be exceeded if the product is used according to the proposed GAP.

For head cabbage, eight trials were submitted in the RR which were conducted according to the proposed GAP. Head cabbage is a major crop therefore 8 residue trials are required. Residues of sulfoxaflor were 6 x <0.01, 0.017, 0.021 mg/kg. The residues of the metabolite X11719474 were below the LOQ in all corresponding samples. Using the OECD calculator an MRL of 0.03 mg/kg is calculated for head cabbage which is covered by the current EU MRL of 0.4 mg/kg.

Leafy brassicas (Kale + Chinese cabbage, kohlrabi, others)


Four trials are available on kale which were conducted according to the proposed GAP. Leafy brassica are considered a minor crop and enough trials are available. Extrapolation to Chinese cabbage is possible with four trials on curly kale according to SANCO 7525/VI/95 Rev. 10.3).

The residues of sulfoxaflor at harvest were <0.01, 0.038, 0.327, 0.421 mg/kg. On the basis of the residue values an MRL of 1.0 mg/kg is calculated for kale using the OECD calculator. The current EM MRL for kale is set at the LOQ of 0.01 mg/k and the current EU MRL for sulfoxaflor on Chinese cabbages is 2.0 mg/kg. The use on kale requires the current EU MRL to be raised. According to zRMS, there is an application ongoing for import tolerance for kale to raise the MRL to 1.0 mg/kg. Currently the use on kale cannot be supported. The use on Chinese cabbage can be supported as the current EU MRL is not exceeded.

kohlrabi


No supervised trials were provided – this use cannot be authorised.

Cucurbits (edible peel – cucumbers, courgettes, gherkins)

cGAP (Indoor): BBCH 20-87; 1-2x; interval 7d 24-48 g a.s. /ha PHI=1d

Eight trials on indoor cucumbers were evaluated which were conducted according to the proposed GAP with one application of approximately 48 g a.s. /ha. According to SANCO


GF-2626


7525/VI/95 Rev. 10.3 trials on cucumbers can be extrapolated to the whole subgroup cucurbits with edible peel.

Residues of sulfoxaflor at harvest (nominal 1-day PHI) were 2x <0.01; 0.011; 0.014; 0.017; 2x 0.027; 0.039 mg/kg. Residues of the metabolite X11719474 were below the LOQ in all corresponding samples. For these data, an MRL of 0.07 mg/kg is calculated using the OECD calculator. The current EU MRL for cucurbits with edible peel (cucumbers, gherkins, courgettes) is 0.5 mg/kg. The proposed use on cucurbits edible peel is covered by the current EU MRL.

Cucurbits (inedible peel – melons, pumpkins/squash, watermelons)

cGAP (Indoor): BBCH 20-87; 1-2x; interval 7d 24-48 g a.s. /ha PHI=1d

Eight trials were conducted on glasshouse-grown melons according to the proposed GAP with one application of approximately 48 g a.s. /ha. According to SANCO 7525/VI/95 Rev. 10.3 trials on melons can be extrapolated to the whole subgroup cucurbits with inedible peel.

Residues of sulfoxaflor at harvest (nominal 1-day PHI) in the whole fruit were 5x <0.01; 2x 0.011; 0.025 mg/kg. The residues of the metabolite X11719474 were below the LOQ in all corresponding samples. On the basis of the trial data, an MRL of 0.04 was calculated using the OECD calculator. The current EU MRL for cucurbits inedible peed (melons, pumpkins & watermelons) is 0.5 mg/kg. The proposed use on cucurbits inedible peel is covered by the current EU MRL.

Potatoes

cGAP (Outdoor): BBCH 20-95; 2x; interval 7d 24 g a.s. /ha PHI=7d

Two trials are available on potatoes representing the northern European. Trials were conducted according to the proposed GAP with two applications of approximately 24 g a.s. /ha. Residues of sulfoxaflor and the metabolite X11719474 at harvest were below the LOQ in all samples. Potatoes are major crops in the Northern EU and 8 residue trials are required to fulfil the GAP requirement. However, in the RR eight additional trials are available which were conducted with an exaggerated application rate at 400 g a.s. /ha (8N). The residues at harvest were at the LOQ of 0.01 mg/kg in all samples. Considering the no residue situation from the trials with an exaggerated application rate, in agreement with the conclusion of the zRMS, two trials are acceptable to support the proposed use of the product on potatoes. The current EU MRL for potatoes is 0.03 mg/kg. Considering the residue values from the trials at the LOQ the current EU MRL would not be exceeded if the product is used on potatoes according to the proposed GAP.

Crops under consideration can be fed to livestock. Feeding studies hens have previously been evaluated in the Draft Assessment Report (DAR), Volume 3, Annex B.7 (2012). No further studies are required or submitted.

Crops under consideration can be rotated with other crops. The nature of the residues of sulfoxaflor in rotational crops and crop rotation field trials were evaluated in the DAR and by EFSA in the Peer Review (EFSA Journal 2014;12(5): 3692). From the field rotational crop study it was shown that no parent compound was recovered in any of the representative


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following crops while the metabolite X11719474 may be recovered at levels above the LOQ occasionally. Nonetheless, in the study the application was made to the bare soil, which represents a worse-case with respect to residue levels. A new field crop rotational study was submitted in the RR. Residue levels of sulfoxaflor and specified soil metabolites were determined in radish, leaf lettuce, spring onion and barley grown as rotational crops after a single application of GF-2626 to bare soil of either 24 g a.i./ha or 48 g a.i./ha. Results showed that residues of sulfoxaflor, X11579457 and X11719474 were either not detected or below the LOQ (<0.01 mg/kg) in all crops at all plant-back intervals except at the 48 g a.i./ha rate, a maximum residue of X11719474 of 0.065 mg/kg was detected in the radish leaves sample of the 30-day PBI in one trial. Considering the high application rate of 48 g a.s./ha to bare soil as worst case scenario, no residues would be expected if the product is applied according to the proposed GAP.

3.1.4.2 Consumer Exposure

The results of the acute and chronic exposure assessments indicate that there is no unacceptable risk to human health from the consumption of commodities treated with sulfoxaflor according to the uses considered in this submission, or in addition to those for which MRLs are already proposed by EFSA.

3.1.5 Environmental fate and behaviour

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5,

Points 9.4 and 9.5)

The PEC of sulfoxaflor and its metabolites, X11719474 and X11519540, in soil has been assessed with the FOCUS model, the FOCUS groundwater interception values (FOCUS (2012)) and EU agreed endpoints (EFSA Journal 2014;12(5):3692).

The maximum initial PECsoil values assuming a single application (use in ornamentals ,1 x 48 gram a.s./ha, interception 10%) for the active substance sulfoxaflor and metabolites X11719474 and X11519540 were 0.0576, 0.0568 and 0.0037 mg/kg, respectively.

The results for PEC soil for the active substance and its metabolites were used for the eco-toxicological risk assessment.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B,

Section 5, Point 9.6)

Groundwater modelling of sulfoxaflor and its major groundwater metabolites, X11719474, X11519540 and X11579457 has been undertaken using the relevant FOCUS groundwater scenario and the FOCUS PEARL 4.4.4 model. The modelling undertaken in this exercise was based on the GAP requested and using the endpoints as in the EFSA conclusion (2014).

PECgw for sulfoxaflor was < 0.01 µg/l in the Kremsmuenster scenario for all crops. For the metabolites X11719474, X11519540 and X11579457, the values were above 0.1 µg/l for all crops but all three metabolites were considered not relevant and the refined risk assessment showed that the estimated intake through drinking water is acceptable for X11719474, X11579457 and X11519540 as it is below the allocation factor of 20% set in the WHO Guidance for Drinking Water Quality. This conclusion is also valid for the simultaneous exposure to all three metabolites.


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Monitoring data groundwater

There are no data available regarding the presence of the substance sulfoxaflor or its metabolites in groundwater.

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B,

Section 5, Points 9.7 and 9.8)

The PEC of sulfoxaflor and its metabolites in surface water (PECsw and PECsed) has been assessed with the TOXSWA-NL model and Dutch specific drift figures and the DT50 water/sediment values established in the ESFA conclusion. Risk mitigation measures of 75% or 90% drift reducing nozzles were also assessed.

For the active substance sulfoxaflor the maximum initial PECsw for the proposed use in ornamentals (1 x 48 g. a.s./ha) was 0.2285 μg/L assuming 1% drift.

For metabolite X11719474 the maximum initial PECsw for the proposed use in ornamentals was 0.1522 μg/L assuming 1% drift.

Besides the standard 50 % drift reduction (1% drift), the applicant proposed to use 75 % and 90 % nozzle reduction. The maximum initial spring PECsed value for sulfoxaflor considering 75% nozzle reduction (0.5% drift) and 90% nozzle reduction (0.5% drift) would be 1.3 µg/kg and 0.52 µg/kg, respectively.

The results for PEC surface water for the active substance and its metabolites were used for the eco-toxicological risk assessment.

Monitoring data surface water

In 2014, version 3 of the Pesticide Atlas was launched, which includes a statistical correlation analysis between concentrations, threshold exceedance and land use, which may indicate probable relationships. In this version also the correlation analysis of land use with the environmental quality standards (EQS) of the Water Framework Directive (WFD) is included.

Data from the Pesticide Atlas are used to evaluate potential exceedances of the authorisation threshold and environmental quality standards (MKN in Dutch, data source http://www.rivm.nl/rvs/Normen). These environmental quality standards consist either of the harmonised WFD thresholds derived according to the Fraunhofer methodology (AA-EQS and MAC-EQS) or of an MPC value (which is usually derived on the basis of outdated guidance). When EQS values according to the Water Framework Directive are available, the MPC value is not used further in the analysis of monitoring data for the purpose of the registration.

There are no data available regarding the presence of the substance sulfoxaflor or its metabolites in surface water.


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Drinking water criterion

Substances are categorized as new substances on the Dutch market (less than 3 years

authorisation) or existing substances on the Dutch market (authorised for more than 3 years).

• For new substances, a pre-registration calculation is performed.

• For existing substances, the assessment is based on monitoring data of VEWIN

(drinking water board).

- if for an existing substance based on monitoring data no problems are expected

by VEWIN, Ctgb follows this VEWIN assessment.

As sulfoxaflor is a new active substance, there are no data available regarding its presence in surface water at drinking water abstraction points. Therefore, the tool DROPLET (described in Alterra report 2020, 2010) was used to calculate concentrations on drinking water abstraction points. Results show that for all drinking water abstraction points the predicted concentrations are below 0.1 µg/L. Therefore, the application of sulfoxaflor is not expected to exceed the drinking water criterion. The standards for surface water destined for the production of drinking water are met.

3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5,

Point 9.9)

The DT50 of sulfoxaflor in air is 0.647 days derived from the Atkinson model. Due to the low volatility [vapour pressure of 1.4 x 10-6 Pa (20 °C) and Henry's Constant Law of 6.83 x 10-7 Pa m3 mol-1] the occurrence of sulfoxaflor in air is very unlikely.

3.1.6 Ecotoxicology

Please refer to the core assessment for non-Dutch specific aspects.

With respect to the uses proposed for the Netherlands, the applicant proposed the use of

the product in flower bulbs and ornamentals, in addition to potato and cabbage. Flower

bulbs however were not assessed in section B.6 of the Core dossier and therefore cannot

be authorised in the Netherlands. Ornamentals were not authorised in the Core

assessment since an in-field risk for non-target arthropods and a risk to earthworms

were identified, and therefore ornamentals cannot be authorised in the Netherlands.

Flower bulbs and ornamentals were therefore not further considered in the NL

addendum.

Therefore, the remaining field uses are potatoes and cabbages.

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)

Birds

Core assessment


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The avian risk assessment, conducted in accordance with the EFSA Bird and Mammal Guidance Document (2009), indicated acceptable acute and chronic risk to birds from sulfoxaflor following application of GF-2626 at all proposed label rates, based on a worst-case screening assessment.

In addition, the screening risk assessment for exposure via drinking water demonstrated an acceptable risk for all proposed uses of GF-2626.

Since sulfoxaflor does not have a log Pow value ≥ 3, risk assessments for birds feeding on fish and earthworms are not necessary for this active substance.

Dutch specific assessment

This information is considered to be relevant for all countries so please refer to the Central Zone assessment. Sulfoxaflor has a log Pow value of 0.802 (at pH 7) indicating a low potential for bioaccumulation in earthworm and fish tissues. Therefore, no assessment of secondary poisoning is required for the Netherlands.

Wild mammals

Core assessment

GF-2626 was a representative formulation in the EU review of sulfoxaflor. However new risk assessment parameters are now considered in the assessment of risk to terrestrial vertebrates other than birds; appropriate risk assessments have been provided and are considered.

The mammalian risk assessment, conducted in accordance with the EFSA Bird and Mammal Guidance Document (2009), indicated an acceptable acute risk to mammals for GF-2626 at all proposed label rates, based on a worst-case screening assessment. The first tier long-term assessment only demonstrated a concern for small herbivorous mammals (vole) for uses in ornamentals, leafy vegetables and pulses. However, for completeness a refined risk assessment was conducted (refinement of DF) which demonstrated an acceptable chronic risk to mammals for GF-2626 when applied to ornamentals, leafy vegetables and pulses.

However, this is not in line with the EFSA guidance on birds and mammals, or the zonal agreements, confirmed by the CZSC: interception can only be taken into account for ornamentals, leafy vegetables and pulses after BBCH 50. Therefore the risk to mammals remain unresolved. An additional refinement arguing that the risk to mammals is not relevant, as agricultural crops are not primary habitats is not accepted as well.

In a third refinement a PD of 50% grasses and 50% non-grass herbs was used. With this refinement the risk to small herbivorous mammals is cabbages was acceptable.

In addition, the screening risk assessment for exposure via drinking water demonstrated an acceptable risk for all proposed uses of GF-2626.

Since sulfoxaflor does not have a log Pow value ≥ 3, risk assessments for mammals feeding on fish and earthworms are not necessary for this active substance.

Sulfoxaflor has a log Pow value of 0.802 (at pH 7) indicating a low potential for bioaccumulation in earthworm and fish tissues. Therefore, no assessment of secondary poisoning is required for the Netherlands.


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3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)


The risk to aquatic organisms was assessed based on the Aquatic Guidance Document (SANCO/ 3268/2001) and the Dutch national requirements for determination of the predicted environmental concentrations in surface water (PECsw) and sediment (PECsed).

The calculated TER values demonstrate an acceptable risk aquatic organisms from all proposed uses of GF-2626 in the Netherlands, when considering the drift mitigation proposed by the applicant (i.e. a 75% nozzle reduction for the proposed use on brassica and a 90% nozzle reduction for the proposed use on potatoes). However, the TERLT values for mysids were calculated for exposure via water (i.e. based on PECsw and the NOEC expressed in µg a.s./L), and the critical aspect of the risk assessment was the acute risk to aquatic insects following exposure via sediment. During this acute risk assessment for aquatic insects, TERA values for ornamentals after exposure via water and sediment based on 1% drift were 2722 and 46, respectively, indicating that exposure via sediment leads to TERA values which are a factor of 59 lower than those via sediment. Therefore, it should be noted that the long-term water spiked test underestimates the risk to chironomids. However, it should also be noted that there also is a considerable margin of safety of a factor of 16 based on the worst-case exposure in ornamentals, which is further increased with a factor of 5 due to the required drift mitigation. Thus the margin of safety is a factor of 80 for the worst-case use in ornamentals, if 0.2% drift is assumed.

At this stage no further information is considered to be necessary.

For cabbages, no drift mitigation is required. As potato is the only other acceptable field use, the required mitigation sentence is as follows:

Om in het water levende organismen te beschermen is toepassing in aardappelen op percelen

die grenzen aan oppervlaktewater uitsluitend toegestaan indien op het gehele perceel gebruik

wordt gemaakt van een techniek uit tenminste de klasse DRT90 in combinatie met een

teeltvrije zone van tenminste 150 centimeter (gemeten vanaf het midden van de laatste

gewasrij tot aan de aan de insteek van de sloot.

Please note that this sentence will be combined with the one for non-target arthropods:

Om in het water levende organismen en niet tot de doelsoorten behorende geleedpotigen/insecten te beschermen is toepassing in aardappelen uitsluitend toegestaan indien op het gehele perceel gebruik wordt gemaakt van een techniek uit tenminste de klasse DRT97.5.

Post risk assessment note:

After risk assessment, the applicant changed their mind and now only want to prescribe a single application in potatoes.

With a single application of 24 g a.s./ha, no additional drift mitigation measures are required.

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and

10.5)


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Effects on bees

Core assessment


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A first tier bee risk assessment was conducted in line with the Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002).

The calculated oral and contact hazard quotients for sulfoxaflor and GF-2626 were above the trigger of 50 indicating the need for a refined risk assessment.

Three semi-field studies were available carried out with GF-2626 in Phacelia in Germany with test doses 24 and 48 g a.s./ha and with different application timing. Further, foliage residue contact laboratory test was available. In addition, the semi-field study by Liepold (2011; not evaluated in EU review) was submitted which investigated the residues of sulfoxaflor, and the main plant metabolite X11719474, in pollen, nectar and plants following application to Phacelia.

The zRMS is of the opinion that the extrapolation of residue decline from Phacelia to potatoes and pulses is appropriate. However, the extrapolation from Phacelia to orchards and to ornamentals is not considered acceptable.

Regarding leafy vegetables the application is only proposed before flowering (BBCH 20-49) and the crop is also harvested before flowering, therefore, there is a low risk for honeybees from foraging on pollen and nectar.

Based on the higher tier studies, it is concluded that the risk to honeybees is acceptable when the product is applied on potatoes and pulses before flowering. Pre-flowering application made 6 days before flowering is considered sufficiently protective by the zRMS. The product can be applied before flowering at the maximum BBCH 59.

During commenting period, some CMSs requested to address risks through succeeding crops, plants on the edge of the field, honeydew and guttation. Regarding risk through succeeding crops, low risk can be expected since sulfoxaflor is of low persistence having the maximum DT50field 7.43 days. Sulfoxaflor rapidly degradates to metabolites which are of low toxicity to bees. Regarding risk through plants on the edge of the field this can be mitigated by warning sentence (e.g. Field edges must not be contaminated by spraying of the product. / Do not apply in the vicinity of flowering weeds). Regarding risks through honeydew and guttation, the zRMS is of the opinion that these are minor exposure routes for crops under evaluation – leafy vegetables, potatoes and pulses. However, if MSs have concerns about risks through honeydew, guttation and through plants on the edge of the field then they should be evaluated at MSs national level.

In addition, flowering weeds which could be present in the field and might be attractive for honeybees should be also considered in mitigation measures.

Since different honeybee management practices are used in individual member states the definitive mitigation measures should be specified at national level. However, a general wording for SPe8 phrase is suggested which can be amended at national level:

Potatoes and pulses:

SPe8: Dangerous to bees. / To protect bees and other pollinating insects do not apply to crop plants when in flower. / Do not use where bees are actively foraging. / Do not apply when flowering weeds are present. / Remove weeds before flowering. / Do not apply later than 6 days before onset of flowering of crop plants.

Leafy vegetables:

SPe8: Dangerous to bees / Do not use where bees are actively foraging. / Do not apply when flowering weeds are present. / Remove weeds before flowering.


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The resulting hazard quotients for all metabolites were below the threshold value of 50, indicating an acceptable risk to honeybees.


In-field risk (cabbage, potato)

The Dutch sentences proposed by the applicant to be included on the Dutch label (WG)

are as follows:

Gevaarlijk voor bijen en hommels. Om de bijen en andere bestuivende insecten te

beschermen mag u dit product niet gebruiken op in bloei staande gewassen of op niet-

bloeiende gewassen wanneer deze actief bezocht worden door bijen en hommels. Gebruik

dit product niet in de buurt van in bloei staand onkruid. Verwijder onkruid voordat het

bloeit. Niet toepassen vanaf 6 dagen voor de start van de bloei van bloeiende gewassen

(aardappelen en bloembollen).

Cabbage is not a bee attractive crop, but pollen from flowering potato plants (but not nectar) are attractive to bees. The safe period of 6 days between application and flowering of potato is confirmed by the core assessment (flower bulbs are not further considered in this NL addendum). The above sentences mitigate the risk due to exposure of bees to flowering weeds growing inside the potato crop. However, the above warning sentence is hard to comply with and hard to enforce, since it may be difficult to establish the exact day when flowering starts.

As it was not possible to describe a clear stage prior to flowering in which application is considered safe for bees, only application after flowering is considered acceptable. The following restriction sentence should be included in the label:

Gevaarlijk voor bijen en hommels. Om de bijen en andere bestuivende insecten te beschermen

mag u dit product niet gebruiken op in bloei staande gewassen of op niet-bloeiende gewassen

wanneer deze actief bezocht worden door bijen en hommels. Toepassing is uitsluitend

toegestaan na de bloei van het aardappelgewas. Gebruik dit product niet in de buurt van in

bloei staand onkruid. Verwijder onkruid voordat het bloeit.

Risk via succeeding crops

In the core assessment it was concluded that the risk following exposure via succeeding crops is low based on a low field DT50 and low risk of metabolites. This is acceptable.

Off-field risk (all crops)

In order for the off-field risk to be acceptable, the HQ should be <50. In case of cabbage and potato, a HQ of <50 is achieved when the dose is lowered by a factor of 50/369=0.136, which corresponds to an off-field drift rate of 13.6%. For the standard drift rate (5.5%) the off-field risk is acceptable for cabbage and potato and flower bulbs, since for these crops a drift rate of 13.6% or less results in acceptable off-field risk. Conclusion: the off-field risk to honeybees is acceptable in cabbage and potato.

Risk via guttation

The Netherlands agree with the conclusion in the core dossier that exposure via guttation fluid is probably a minor route. Furthermore, the confirmatory data do not indicate any risk resulting from exposure to guttation fluid (although via other crops than potato and cabbage). In addition, the proposed warning sentence (Do not use where bees are actively foraging) will


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prevent that the product is applied at a time that large numbers of bees could be consuming guttation fluid. The risk through guttation is therefore considered acceptable.

Risk via honeydew

The product CLOSER (GF-2626) is used in all crops for control of aphids. Therefore, at least during the first weeks after treatment, the exposure of honeybees to honeydew could be low. As honeybees are not more sensitive than aphids, the DT50 for sulfoxaflor in honeydew is expected to be low (in the order of days) and the rate of re-infestation in aphids is 1-2 months, the risk to bees after exposure via honeydew is considered to be acceptable.

Effects on other non-target arthropod species

Core assessment

The risk assessment for non-target arthropods was conducted in line with ESCORT 2 (Candolfi et al., 2001), based on data for the proposed formulated product (GF-2626) as well as GF-2372 and GF-2032. It was considered appropriate to extrapolate toxicity data for these products to GF-2626, due to the comparable toxicity to non-target arthropods. The first tier risk assessment demonstrated acceptable off-field and in-field risks to T. pyri for all the proposed uses of GF-2626. However, the in-field and off-field HQs for A. rhopalosiphi indicated the need for a further risk assessment.

For refinement of off-field risk, off-field study simulating drift events on non-target arthropod communities of grassy field margins carried out in south-west France using GF-2626 was provided. Since recovery cannot be tolerated in the off-field area to enable recovery in the in-field area, buffer zone mitigation has been considered using the NOAEER of 9.6 g sulfoxaflor/ha and an assessment factor of 5 covering the uncertainties associated with recovery of some taxa and location of the study. It has been concluded that the off-field risk to non-target arthropods is acceptable for use on brassicas and potatoes without considering a buffer zone, for use on pulses and ornamentals considering a buffer zone of 5 m and for use on pome/stone fruits considering a buffer zone of 20 m.

For refinement of in-field risk, an aged residue test on the most sensitive species, A.

rhopalosiphi, carried out with GF-2626 and two in-field studies conducted in cereals in south-west France and in Netherland using GF-2372, were available. The results of the in-field studies can be extrapolated to leafy vegetables, potatoes and pulses but extrapolation to orchards and ornamentals is not considered acceptable.

Overall, on this basis the risk to non-target arthropods is considered acceptable, except for use on pome/stone fruits and ornamentals.


Based on laboratory studies, off-field HQs for T. pyri are below the trigger value of 2, indicating an acceptable risk, and no further testing is required on this species. The off-field HQs for A. rhopalosiphi are greater than the trigger value of 2, indicating the need for a higher tier risk assessment.

By comparison of the in-field and off-field PERs to the extended laboratory endpoints an unacceptable in-field and off-field risk is indicated for A. rhopalosiphi. An acceptable off-field risk was indicated for A. bilineata for all crops, plus an acceptable in-field risk from use on brassicas. However, an acceptable in-field risk from use on potatoes could not be


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demonstrated, as the product GF-2032 was not tested at a high enough rate, i.e. 24 g a.s./ha. An acceptable in-field and off-field risk was indicated for C. carnea for all proposed uses. Consequently further consideration is necessary for both in-field and off-field communities of non-target arthropods.

I) refined in-field risk assessment

In an aged residue test on the most sensitive species, A. rhopalosiphi, carried out with GF-2626 at test rates representative of in-field exposure (48 and 24 g a.s./ha), less than 50% effects were noted on mortality and parasitism when aged for 21 days. In comparison with 100% mortality when exposed to freshly treated foliage, a distinct decline in potential adverse effects with time after treatment is demonstrated. These findings are also supported by the results of two cereal field studies (one northern and one southern EU trial). Extrapolation from cereals is considered to be acceptable for cabbage and potato, hence the in-field risk is considered acceptable for cabbage and potato.

II) Off-field risk assessment

To cover the uncertainties associated with recovery of some taxa and location of the off-field dose-response study by Bakker (2011), an assessment factor of 5 on the NOAEEC of this study of 9.6 g a.s./ha) has been used by the applicant in calculation of drift reducing nozzles and buffer zones. Considering that the environmental conditions during this trial in Southern France were not remarkably different of those in the Netherlands during the application period, and that the consistent NOER from this study is obtained for the target species of Aphidiidae (expected to be most sensitive to sulfoxaflor), the RAC proposed by the applicant (1.92 g a.s./ha, obtained by dividing the NOAEER of 9.6 g a.s./ha by the assessment factor of 5) is considered to be protective for the risk assessment in the Netherlands.

As the maximum off-field exposure should not exceed 1.92 g a.s./ha, the maximum drift for each proposed use is as follows:

-brassica’s (1 x 24 ga.s./ha): 8% drift

-potato (2 x 24 g a.s./;ha, MAF = 1.7): 4.7%

Based on the above, the risk to off-field communities of non-target arthropods due to applications of sulfoxaflor is considered acceptable when a range of drift reducing measures are put into place.

With the entry into force of the new Activity Decree 75% drift reduction on the whole field has to be applied.

For the assessment for downwards sprayed crops this means that the drift percentage of 5.5% belonging to the reference spray technique of the DRT class 75, will be used. This means that for cabbage no restriction sentence is required.

For potato this means that the drift percentage of 5.5% belonging to spray techniques of the DRT class 75, 90 and 95 is not acceptable. The drift percentage of 1.6% belonging to spray techniques of the DRT class 97.5 is acceptable. The following restriction sentence will be placed on the Dutch WG:

Om niet tot de doelsoorten behorende geleedpotigen/ insecten te beschermen is toepassing in

aardappelen uitsluitend toegestaan indien op het gehele perceelgebruik wordt gemaakt van

een techniek uit tenminste de klasse DRT97.5.

Please note that this sentence will be combined with the one for aquatic organisms:

Om in het water levende organismen en niet tot de doelsoorten behorende

geleedpotigen/insecten te beschermen is toepassing in aardappelen uitsluitend toegestaan


GF-2626


indien op het gehele perceel gebruik wordt gemaakt van een techniek uit tenminste de klasse

DRT97.5.

Post risk assessment note:

After risk assessment, the applicant changed their mind and now only want to prescribe a single application in potatoes.

With a single application of 24 g a.s./ha, no additional drift mitigation measures are required.

3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6,

Point 10.6)

Core assessment

The risk to earthworms and other soil macro-invertebrates was assessed in line with the Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002).

The calculated TERA values were greater than the trigger value for GF-2626, sulfoxaflor and the potentially relevant metabolite X11719474, indicating an acceptable acute risk to earthworms from the proposed uses of GF-2626. The calculated TERLT values were greater than the trigger value for GF-2626, sulfoxaflor and the potentially relevant metabolites X11719474 and X11519540, indicating acceptable chronic risk to earthworms, except for GF-2626 and sulfoxaflor for application to pome/stone fruit and ornamentals and for GF-2626 for applications to brassicas, indicating a potential long-term risk to earthworms. However, the TERLT values for pome/stone fruit were below the trigger value for application rates 2 x 48 g a.s./ha and 2 x 24 g a.s./ha, indicating a potential long-term risk to earthworms, while for application rate 1 x 24 g a.s./ha, the TERLT values were above the trigger value indicating an acceptable chronic risk to earthworms.

The earthworm field study was available but it could not be demonstrated that the proposed GAP is covered with the exposure of earthworms in the study, therefore the study could not be used in the risk assessment.

An unacceptable risk to earthworms cannot be excluded for uses of GF-2626 on pome/stone fruit (application rates 2 x 48 g a.s./ha and 2 x 24 g a.s./ha) and ornamentals.

Regarding brassicas, the TERLT value for sulfoxaflor is above the trigger of 5, while TERLT value for product is above the trigger of 5 but TER value is very close to trigger of 5 (4.74). Therefore, it is proposed to leave the final decision at MS level since weight of evidence can be used based e.g. on land area where the brassicas is grown in relevant MS.

The TERLT values for GF-2626 and sulfoxaflor soil metabolites for soil non-target organisms were all above the trigger value of 5, indicating an acceptable chronic risk to other soil non-target organisms from the proposed uses of GF-2626.


The applicant stated that this information is considered to be relevant for all countries and referred to the core assessment. The core assessment however drew the following conclusion on brassica: “Regarding brassicas, the TERLT value for sulfoxaflor is above the trigger of 5,

while TERLT value for product is above the trigger of 5 but TER value is very close to trigger

of 5 (4.74). Therefore, it is proposed to leave the final decision at MS level since weight of


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evidence can be used based e.g. on land area where the brassicas is grown in relevant MS.”. The fact that the TERLT based on the NOEC for the formulation is slightly less than 5 is not considered to be indicative of a risk, but rather the consequence of the choice of the dose levels in the sublethal toxicity test with the formulation. These dose levels were 0.75, 1.5, 3, 6 and 12 mg formulation/kg soil dry weight, and the NOEC was determined to be 0.75 mg formulation/kg soil dry weight equivalent to 0.09 mg a.s./kg soil dry weight, and at this dose there were no effects at all on mortality, worm weight and and reproduction. Considering that the NOEC for sulfoxaflor was 0.1 mg a.s./kg soil dry weight, the difference in endpoint between formulation and active ingredient is not considered to be due to a difference in toxicity, but due to the choice of dose levels in the study with the formulation. Therefore the long-term risk to earthworms in brassica is considered to be acceptable.

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6)

Core assessment

Studies on the effects of sulfoxaflor on organic matter breakdown are not triggered because the DT90f is less than 100 days. However given the high soil persistence of the metabolites X11719474 and X11519540 a litter bag study was carried out with GF-2626 and the metabolite X11719474. Since no impact on the organic matter breakdown was determined in this study and no effects of the metabolite X11519540 on the reproduction of Collembola and gammasid mites were reported, no further studies are needed.


Please refer to the core assessment.

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)

Core assessment

The risk to soil micro-organisms was assessed in line with the Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002). When applying GF-2626 according to the proposed representative GAPs on pome/stone fruit, fruiting vegetables, leafy vegetables, potatoes, beans, peas and ornamentals, no negative effects on microbial activities were to be expected.


This information is considered to be relevant for all countries so please refer to the Central Zone assessment.

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and

Fauna) (Part B, Section 6, Point 10.8)

Non-Target Plants



GF-2626


A risk assessment for terrestrial non-target plants has been conducted using the standard drift value of 4.7% for field crops following Dutch national requirements with consideration to the critical GAP for the Netherlands and gave a low risk (TER >43 for a worst case assessment).

Other non-target species (Flora and Fauna)

Tests on other non-target species are not required.

3.1.7 Efficacy

It concerns a label extension. CLOSER is already authorised in a range of protected crops.

Please refer to the core dossier for the evaluation by the zRMS.

Preliminary tests

2 preliminary trials evaluating pre-emergence herbicidal activity and 2 trials evaluating post-emergence herbicidal activity of showed no observed effects Sulfoxaflor on tested monocot and dicot species. High-throughput screens (HTS) demonstrated that Sulfoxaflor at 5 ppm did not show activity on 4 fungal species representing 3 fungal phyla. Sulfoxaflor demonstrated high activity on sap feeding pests (aphids & whiteflies) in laboratory and field trials.

Minimum effective dose

MED for Brevicoryne brassicae control in brassicas

This use is claimed under article 51 as a minor use. As such no efficacy evaluation is required. Cauliflower is not claimed in the Netherlands.

MED for aphids control in potatoes

Trials were carried in Maritime zone, mostly with one application. In fourteen of the sixteen MED trials pest pressure was assessed as aphids/leaf (range from 1.38 to 16.7 aphids / leaf at application). Sufficient data was provided to support the proposed dose rate 24 g a.s./ha of Sulfoxaflor as the MED on aphids in potatoes in the EPPO Maritime zone.

MED for aphid control in ornamental crops

Since ornamental crops are major in the Netherlands justification for MED should be done based on trials conducted in the Maritime zone. The extrapolation from Italian studies is not sufficient for NL registration. Based on submitted data alone an authorization is not possible, please refer to the section on extrapolations.

Efficacy data

Aphids (BRVCBR) in Brassicas - field use

This use is now claimed under article 51. As such no efficacy data is required. Cauliflower is not claimed in the Netherlands.

Aphids (MACSEU, AULASO, MYZUPE, APHIFA, APHINA) in Potato- field use


GF-2626


All 21 trials were conducted in the Maritime zone. The green peach aphid Myzus persicae (MYZUPE) was the dominant species found in the trials. Further aphid species present in the trials were the potato aphid (Macrosiphum euphorbiae, MACSEU), buckthorn aphid (Aphis

nasturtii, APHINA), foxglove aphid (Aulacorthum solani, AULASO, not claimed in the Netherlands), cotton aphid (Aphis gossypii, APHIGO) and the bean aphid (Aphis fabae, APHIFA). Mixed results of all trials with different aphids showed that CLOSER demonstrated comparable or higher efficacy comparing to reference products. Following the conclusion of zRMS an authorization can be granted on claim that Sulfoxaflor provided effective control of aphid species MYZUPE, APHINA, APHIFA & MACSEU on potato crops in the Maritime zone within the Central zone. One application is carried out in most of the trials. Spraying volume in the GAP has been adjusted from 200-600 L/ha to 200-400 L/ha, as only 200-300 L/ha has been applied in the trials and that can be extrapolate to 200- 400 L/ha according to the Dutch standard.

The following is concluded in the core.

Label amendments:

As the APHIGO & AULASO effectiveness label claims were not adequately supported all

references to APHIGO & AULASO should be removed from the potato section of the GF-

2626 draft label.

AULOSA is not claimed in NL, the claim for APHIGO has been removed.

Aphids (MYZUPE, MACSEU, MACSRO, APHYGO, PHYAFA) in Ornamentals – field use

Only one trial in Maritime zone and 5 trials in Italy. Mixed results were presented, with big variation on some of the observation dates. One trial in Maritime zone is not sufficient for authorize the claimed use. Ornamental plants are minor use in the Netherlands. However from field use of Brassica crops and potatoes extrapolation is not possible. Based on submitted data alone an authorization is not possible; please refer to the section on extrapolations.

Whitefly (TRIAVA, BEMITA) in Ornamentals - field use

No trial in Maritime zone. Only 5 trials in Italy were provided. Based on submitted data alone an authorization is not possible; please refer to the section on extrapolations.

Extrapolations:

The core dossier does not take into account that the product is already authorized in the Netherlands in protected ornamentals. For most aphids extrapolation is not possible (please refer to the Dutch extrapolation document) as climatic circumstances are very different, and many aphids have higher pest pressure outdoors. This however is not true for APHIGO which only occurs sporadically outside. This species can be extrapolated.

For similar reasons for both whitefly species extrapolation is possible from protected to unprotected conditions.

The dossier for the protected crops also included a label claim for flower bulb crops, however this was rejected due to a lack of data. As such no extrapolation is possible to unprotected flower bulb crops.

Yield and quality


GF-2626


No phytotoxicity symptoms is seen in the efficacy trials. No negative impact on the quality and yield of plants and plant products is to be expected when Sulfoxaflor is applied as recommended. It should be noted that for potato, one application is carried out in most of the efficacy trials while 1-2 application is submitted in the GAP. However in the phytotoxicity trials application are repeated up to 6-7 times.

Adverse effects

Phytotoxicity to Brassica Crops

Data was presented from 7 EPPO Maritime & 3 EPPO North-East zone on Cauliflower, and Head Cabbage. An additional GEP head cabbage trial report from AT also assessed Sulfoxaflor selectivity. Sulfoxaflor was applied at 24 g a.s./ha in all 11 trials between BBCH 14-49 in 200-500 l/ha spray volume on 9 brassica cultivars. No instances of phytotoxicity were recorded for any of the Sulfoxaflor formulations tested in these European brassica trials.

Phytotoxicity to Potatoes

Data was presented from 17 efficacy field trials conducted in the Maritime zone. The majority of trials were conducted in line with EPPO standards with the remainder having a smaller net plot size or smaller sample size assessed. Sulfoxaflor was applied at 24 g a.s./ha in all 18 trials on 13 potato varieties with a 36 g a.s./ha rate in 6 trials & the 24 g a.s./ha rate applied 6 & 7 times in 1 trial each. No instances of phytotoxicity were recorded for any of the Sulfoxaflor formulations tested in these Maritime zone potato trials.

Phytotoxicity to Ornamentals

Data was presented from 6 ornamental efficacy field trials in the Southern zone. GEP certificates were available for 5 of these trials. Sulfoxaflor was applied at 24 g a.s./ha in all 6 trials with a 48 g a.s./ha rate in 4 trials between BBCH 33-64. Data was also presented from 3 Southern zone (IT) ornamental efficacy glasshouse trials with Sulfoxaflor applied at 24 g a.s./ha in 3 trials & a 48 g a.s./ha rate in 2 trials which can be extrapolated to outdoor ornamentals as protected crops are more sensitive. No instances of phytotoxicity were recorded in any of the Sulfoxaflor treated ornamental trials.

The current label already includes a label warning for ornamentals that is also of relevance for the new claim for unprotected ornamentals:

Gezien het grote aantal variëteiten en de wisselende teeltomstandigheden van bloemisterijgewassen is het onmogelijk de gewasverdraagzaamheid voor alle situaties te onderzoeken. Als er nog geen ervaring is opgedaan met dit middel wordt aangeraden om eerst een proefbespuiting uit te voeren om de verdraagzaamheid van het gewas te testen.

Succeeding / Adjacent crops

No negative impact on succeeding/adjacent crops is to be expected if CLOSER is applied according to label recommendations.


GF-2626


Resistance

Sulfoxaflor belongs to the Sulfoximines family, IRAC group 4C. A Resistance Risk Assessment was carried out following EPPO guideline PP 1/213 (3), and Resistance Management Guidelines were established targeting the most exposed species. It was concluded that Sulfoxaflor is differentiated from other insecticides and no cross resistance is likely to exist in current populations. The resistance risk for aphids such as MYZUPE & APHIGO and whiteflies such as BEMITA & TRIAVA developing resistance to Sulfoxaflor is medium to high. ZRMS concluded that there is currently no evidence of resistance to Sulfoxaflor for any species and considering the proposed GF-2626 label resistance management guidance no further restrictions in terms of management are deemed necessary for the time being.

In the Dutch label the following warning sentences are proposed:

Resistentiemanagement

Dit middel bevat de werkzame stof sulfoxaflor en behoort tot de sulfoxamines. De Irac code is 4C. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.

3.2 Conclusions

The assessment conducted for CLOSER was in accordance with the Uniform Principles and demonstrates an acceptable risk to human health and the environment. An authorisation can be granted for the use in potatoes, broccoli, heading cabbage, Brussels sprouts and Chinese cabbage.

Note:

At the request of the applicant, the number of uses in potatoes was changed during the

evaluation. The number of uses was changed from two uses to one use. The consequence

of this change has been evaluated for each aspect and only when necessary (the need for

PPE / restrictions / conclusions) changes were made.

3.3 Further information to permit a decision to be made or to support a review of the

conditions and restrictions associated with the authorisation

None.


GF-2626


Appendix 1 Copy of the proposed product label

Wettelijk Gebruiksvoorschrift Het middel is uitsluitend toegelaten als insectenbestrijdingsmiddel voor het professionele gebruik door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.1, Ctgb juni 2015) onder de hierna vermelde toepassingsvoorwaarden. Toepassingsvoorwaarden:

Toepassingsgebied Werkzaamheid getoetst op

Dosering* (middel) per toepassing

Maximale dosering per toepassing

Maximaal aantal toepassingen per 12 maanden

Maximaal aantal liter middel per ha per 12 maanden

Minimum interval tussen toepassingen in dagen

Veiligheids-termijn in dagen

Aardappelen

Bladluis1,2,3,4 0,2 L/ha 0,2 L/ha 1 0,2 L/ha - 7

Vruchtgroenten van Cucurbitaceae met eetbare schil (bedekte teelt)

Bladluis3,5 0,013% (13 ml per 100 L)

0,2 L/ha 2 0,4 L/ha

7

1

Wittevlieg7,8 0,013% (13 ml per 100 L)

0,2 L/ha 2

0,026% (26 ml per 100 L)

0,4 L/ha 1

Vruchtgroenten van Cucurbitaceae met niet-eetbare schil (bedekte teelt)

Bladluis3,5 0,013% (13 ml per 100 L)

0,2 L/ha 2 0,4 L/ha

7

1


0,2 L/ha 2

0,026% (26 ml per 100 L)

0,4 L/ha 1

Vruchtgroenten van Solanaceae (bedekte teelt)

Bladluis3,5 0,013% (13 ml per 100 L)

0,2 L/ha 2 0,4 L/ha

7

1


0,2 L/ha 2


GF-2626


Toepassingsgebied Werkzaamheid getoetst op

Dosering* (middel) per toepassing

Maximale dosering per toepassing


Maximaal aantal liter middel per ha per 12 maanden

Minimum interval tussen toepassingen in dagen

Veiligheids-termijn in dagen

0,026% (26 ml per 100 L)

0,4 L/ha 1

Bloemisterijgewassen (bedekte teelt)

Bladluis1,3,5 0,013% (13 ml per 100 L)

0,2 L/ha 2 0,4 L/ha

7

-


0,2 L/ha 2

0,026% (26 ml per 100 L)

0,4 L/ha 1

* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. Werkzaamheid is vastgesteld voor de genoemde dosering per toepassing en niet voor verlaagde doseringen. 1 Aardappeltopluis (Macrosiphum euphorbiae) 2 Vuilboomluis (Aphis nasturtii) 3 Groene perzikluis (Myzus persicae) 4 Zwarte boneluis (Aphis fabae) 5 Katoenluis (Aphis gossypii) 6 Tabakswittevlieg (Bemisia tabaci) 7 Wittevlieg (Trialeurodes vaporariorum) Het gebruik in de teelt van sluitkoolachtigen, broccoli en Chinese kool is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassing/en geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren voordat het middel gebruikt wordt. Het risico voor het gewas bij gebruik van dit middel in dit/deze toepassingsgebied/en valt onder verantwoordelijkheid van de gebruiker.


GF-2626


Toepassingsgebied Werkzaamheid aannemelijk tegen

Dosering* middel per toepassing


Veiligheidstermijn in dagen

Sluitkoolachtigen (onbedekte teelt)

Bladluis8 0,2 L/ha 1 7

Broccoli (onbedekte teelt)


Chinese kool (onbedekte teelt)


* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. 8 Melige koolluis (Brevicoryne brassicae)

Overige toepassingsvoorwaarden In de teelt van aardappel het middel toepassen in 200-400 liter water per hectare. In de teelt van sluitkoolachtigen, broccoli en chinese kool het middel toepassen in 200-1000 liter water per hectare. Gevaarlijk voor bijen en hommels. Om de bijen en andere bestuivende insecten te beschermen mag u dit product niet gebruiken op in bloei staande gewassen of op niet-bloeiende gewassen wanneer deze actief bezocht worden door bijen en hommels. Toepassing is uitsluitend toegestaan na de bloei van het aardappelgewas. Gebruik dit product niet in de buurt van in bloei staand onkruid. Verwijder onkruid voordat het bloeit. Gevaarlijk voor bijen en hommels. Voorkom dat bijen en andere bestuivende insecten de kas binnenkomen, bijvoorbeeld door alle openingen met insectengaas af te sluiten. Let op: dit middel kan schadelijk zijn voor bestuivers en natuurlijke vijanden in kasteelten. Raadpleeg deskundigen (uw leverancier van bestuivers of natuurlijke vijanden, de producent van dit middel, uw adviseur) over het gebruik van dit middel in combinatie met het gebruik van bestuivers of natuurlijke vijanden en over de in acht te nemen wachttijden.


GF-2626


De gewasveiligheid van het middel in de wintermaanden is voor de bedekte teelten van vruchtgroenten van Cucurbitaceae met en zonder eetbare schil, vruchtgroenten van Solanaceae en bloemistrijgewassen niet onderbouwd. Voer een proefbespuiting uit voordat het middel in de bedekte teelt van deze gewassen op grote schaal toegepast wordt. Gezien het grote aantal variëteiten en de wisselende teeltomstandigheden van bloemisterijgewassen is het onmogelijk de gewasverdraagzaamheid voor alle situaties te onderzoeken. Als er nog geen ervaring is opgedaan met dit middel wordt aangeraden om eerst een proefbespuiting uit te voeren om de verdraagzaamheid van het gewas te testen.

Resistentiemanagement Dit middel bevat de werkzame stof sulfoxaflor en behoort tot de sulfoxamines. De Irac code is 4C. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.


GF-2626


Appendix 3 Letter of Access

Not applicable.


GF-2626


Appendix 4 List of data submitted in support of the application

Physical and chemical properties and analytical methods

Annex Point/

Reference

Number

Year Title

Source (where different from

the Company),

Company, Report Number,

GLP or GEP status (where

relevant),

Published or not

Data

Protection

claimed

(Y/N)

Study

relied on

Y/N

Data

protection

granted

Y/N

Owner

KIIIA1 2.1 KIIIA1 2.2.1/1 KIIIA1 2.3.1 KIIIA1 2.4.2/1 KIIIA1 2.5.2 KIIIA1 2.6.1

2011 Determination of Color, Odor, Physical State, Oxidizing and Reducing Action, Flashpoint, Explodability, pH, Viscosity, and Denisty of GF-2626, an End-Use Product Containing Sulfoxaflor Source: Dow AgroSciences LLC, Indianapolis, IN; USA Report No.: FAPC-G-11-27 GLP/GEP (Y/N): Y Published (Y/N): N

Y Y Y DAS

KIIIA1 2.2.1/2 KIIIA1 2.2.2

2011 Oxidising and Explosive Properties Waiver for GF-2626 Source: Dow AgroSciences LLC, Indianapolis, IN; USA Report No.: NAFST-11-176 GLP/GEP (Y/N): N Published (Y/N): N

Y Y Y DAS

KIIIA1 2.3.3

KIIIA1 2.5.5

2011 Determination of Surface Tension and Auto-Ignition Temperature for GF-2626 Source: Dow AgroSciences LLC, Indianapolis, IN; USA Source: Huntingdon Life Sciences Ltd Report No.: NAFST-11-2 GLP/GEP (Y/N): Y Published (Y/N): N

Y Y Y DAS


GF-2626


Annex Point/

Reference

Number

Year Title


the Company),



relevant),

Published or not

Data

Protection

claimed

(Y/N)

Study

relied on

Y/N

Data

protection

granted

Y/N

Owner

KIIIA1 2.4.2/2 KIIIA1 2.7.1 KIIIA1 2.7.2 KIIIA1 2.7.4 KIIIA1 2.8.2; KIIIA1 2.8.3.1; KIIIA1 2.8.3.2; KIIIA1 2.8.5.2; KIIIA1 2.8.8.2;

2011 GF-2626: Laboratory Study of Accelerated Storage Stability at 54 ˚C and Stability at 0 ˚C Source: International Institute of Biotechnology and Toxicology, Tamil Nadu, India Report No.: NAFST-11-64 GLP/GEP (Y/N): Y Published (Y/N): N

Y Y Y DAS

KIIIA1 2.7.5 KIIIA1 2.7.6

2014 GF-2626: Three Year Laboratory Study of Storage and Corrosion Characteristics at Ambient Temperatures in PET and HDPE Bottles Source: International Institute of Biotechnology and Toxicology, Tamil Nadu, India Report No.: NAFST-12-315 GLP/GEP (Y/N): Y Published (Y/N): N

Y Y Y DAS

KIIIA1 4.1.2

2010 Analytical Method and Validation for the Determination of XDE-208 in GF-2372 and GF-2032 End Use Products and in XDE-208 Technical Grade Active Ingredient Dow AgroSciences LLC Report No.: DAS-AM-G-09-19 GLP/GEP (Y/N): Y Published (Y/N): N

Y Y Y DAS

Annex Point Year Title


company)

Company

Report No.

GLP or GEP status

Published or unpublished

Data

protection

claimed

(Y/N)

Study

relied on

Y/N

Data

protection

granted

Y/N

Owner


GF-2626




company)

Company

Report No.

GLP or GEP status


Data

protection

claimed

(Y/N)

Study

relied on

Y/N

Data

protection

granted

Y/N

Owner

KIIIA1 5.2.1 2010 Analytical Method and Validation for the Determination of XDE-208 in GF-2372 and GF-2032 End Use Products and in XDE-208 Technical Grade Active Ingredient

Report No.: DAS-AM-G-09-19 GLP/GEP (Y/N): Y Published (Y/N): N

Y Y Y DAS

Mammalian toxicology

Annex

Point/

Reference

Number

Year Title

Source (where

different from the

Company),

Company, Report

Number,

GLP or GEP

status (where

relevant),

Published or not

Data

Protection

claimed

(Y/N)

Data

protection

granted

(Y/N)

Study

used

(Y/N)

Owner

KIIIA 7.1.1

2009 GF-2032: Acute Oral Toxic Class Method in Rats

Y Y Y DAS

Report No.:

080049

GLP/GEP (Y/N):

Y

Published (Y/N):

N

KIIIA 7.1.2

2009a GF-2032: Acute Dermal Toxicity Study in Rats

Y Y Y DAS

Report No.:

080050

GLP/GEP (Y/N):

Y


GF-2626


Annex

Point/

Reference

Number

Year Title

Source (where

different from the

Company),

Company, Report

Number,

GLP or GEP

status (where

relevant),

Published or not

Data

Protection

claimed

(Y/N)

Data

protection

granted

(Y/N)

Study

used

(Y/N)

Owner

Published (Y/N):

N

KIIIA 7.1.3

2012 GF-2032: Acute Liquid Aerosol Inhalation Toxicity Study in F344/Ducrl Rats

Y Y Y DAS

Report No.:

081191

GLP/GEP (Y/N):

Y

Published (Y/N):

N

KIIIA 7.1.4

2009b GF2032: Primary Skin Irritaton Study in Rabbits

Y Y Y DAS

Report No.:

080051

GLP/GEP (Y/N):

Y

Published (Y/N):

N

KIIIA 7.1.5

2009c GF-2032: Primary Eye Irritation Study in Rabbits

Y Y Y DAS

Report No.:

080052

GLP/GEP (Y/N):

Y

Published (Y/N):

N


GF-2626


Annex

Point/

Reference

Number

Year Title

Source (where

different from the

Company),

Company, Report

Number,

GLP or GEP

status (where

relevant),

Published or not

Data

Protection

claimed

(Y/N)

Data

protection

granted

(Y/N)

Study

used

(Y/N)

Owner

KIIIA 7.1.6

2008 GF-2032: Local Lymph Node Assay in CBA/J Mice

Y Y Y DAS

Report No.:

081180

GLP/GEP (Y/N):

Y

Published (Y/N):

N

Report No.:

191168

GLP/GEP (Y/N):

Y

Published (Y/N):

N

Report No.:

786740

GLP/GEP (Y/N):

Y

Published (Y/N):

N

Metabolism and Residues


Source (where different

from company)

Company

Report No.

GLP or GEP status (Y/N)


Data

protection

claimed

(Y/N)

Study

relied on

Y/N

Data

protection

granted

(Y/N)

Owner


GF-2626




from company)

Company

Report No.



Data

protection

claimed

(Y/N)

Study

relied on

Y/N

Data

protection

granted

(Y/N)

Owner

IIIA 8.3.3/01 2012h Residues of sulfoxaflor in potatoes at intervals and harvest following multiple applications of GF-2626 – Northern and southern Europe – 2011

Dow AgroSciences

DAS report CEMR-5026

Y

Unpublished

Y Y Y DAS

IIIA 8.3.4.1/01 2011a Residues of XDE-208 in indoor tomatoes at intervals and harvest

Following a single application of GF-2626 – Europe – 2010

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.4.1/02 2012i Residues of sulfoxaflor in indoor tomatoes at intervals and harvest following a single application of GF-2626 – Europe – 2011

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.4.2/01 2011b Residues of XDE-208 in indoor peppers at intervals and harvest

following a single application of GF-2626 – Europe – 2010

Dow AgroSciences


Y

Unpublished

Y Y Y DAS


GF-2626




from company)

Company

Report No.



Data

protection

claimed

(Y/N)

Study

relied on

Y/N

Data

protection

granted

(Y/N)

Owner

IIIA 8.3.4.2/02 2011c Residues of sulfoxaflor in indoor bell peppers at intervals and harvest following a single application of GF-2626 – Europe – 2011

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.5.1/01 2011d Residues of XDE-208 in indoor cucumbers at intervals and harvest following a single application of GF-2626 – Europe – 2010

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.5.1/02 2012j Residues of sulfoxaflor in indoor cucumbers at intervals and harvest following a single application of GF-2626 – Europe – 2011

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.5.2/01 2011e Residues of XDE-208 in indoor melons at intervals and harvest following a single application of GF-2626 – Europe – 2010

Dow AgroSciences


Y

Unpublished

Y Y Y DAS


GF-2626




from company)

Company

Report No.



Data

protection

claimed

(Y/N)

Study

relied on

Y/N

Data

protection

granted

(Y/N)

Owner

IIIA 8.3.5.2/02 2012k Residues of sulfoxaflor in indoor melons at intervals and harvest following a single application of GF-2626 – Europe – 2011

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.6.1/01 2012(l) Residues of XDE-208 in broccoli at intervals and harvest following a

single application of GF-2032 – Northern and Southern Europe - 2008

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.6.1/02 2012m Residues of sulfoxaflor in broccoli at intervals and harvest following a single application of GF-2626 – Northern and Southern Europe – 2011

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.6.1/03 2012n Residues of XDE-208 in cauliflower at intervals and harvest following a single application of GF-2032 – Northern and Southern Europe - 2008

Dow AgroSciences


Y

Unpublished

Y Y Y DAS


GF-2626




from company)

Company

Report No.



Data

protection

claimed

(Y/N)

Study

relied on

Y/N

Data

protection

granted

(Y/N)

Owner

IIIA 8.3.6.1/04 2012(o) Residues of sulfoxaflor in cauliflower at intervals and harvest

following a single application of GF-2626 – Northern and Southern Europe – 2011

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.6.2/01 2010h Residues of XDE-208 in Brussels sprouts at intervals and harvest following a single application of GF-2032 – Northern and southern Europe – 2008

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.6.2/02 2012p Residues of sulfoxaflor in Brussels sprouts at intervals and harvest following a single application of GF-2626 – Northern and Southern Europe – 2011

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.6.3/01 2012q Residues of XDE-208 in head cabbage at intervals and harvest following a single application of GF-2032 – Northern and Southern Europe – 2008

Dow AgroSciences


Y

Unpublished

Y Y Y DAS


GF-2626




from company)

Company

Report No.



Data

protection

claimed

(Y/N)

Study

relied on

Y/N

Data

protection

granted

(Y/N)

Owner

IIIA 8.3.6.3/02 2012r Residues of sulfoxaflor in head cabbage at intervals and harvest following a single application of GF-2626 – Northern and Southern Europe – 2011

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.6.4/01 2012s Residues of XDE-208 in kale at intervals and harvest following a single application of GF-2032 – Northern and Southern Europe – 2008

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.3.6.4/02 2012t Residues of sulfoxaflor in kale at intervals and harvest following a single application of GF-262 – Northern and Southern Europe – 2011

Dow AgroSciences


Y

Unpublished

Y Y Y DAS

IIIA 8.6.1/01 2013 Determination of residues of XDE-208 after one application of GF-2626 on bare soil in rotational crops (radish, leaf lettuce, spring onion and barley) at 2 sites in Northern Europe and 2 sites in Southern Europe 2011 / 2012

Dow AgroSciences

DAS report 110385

Y

Unpublished

Y Y Y DAS


GF-2626




from company)

Company

Report No.



Data

protection

claimed

(Y/N)

Study

relied on

Y/N

Data

protection

granted

(Y/N)

Owner

IIIA 8.3.3 2010 Residue of XDE-208 in potatoes at intervals and harvest following multiple applications of GF-2032 – Northern and Southern Europe – 2008

Dow AgroSciences

Report number: CEMR-3933

Study Number: 080028-02

Y

Unpublished

Y Y Y DAS

Environmental fate and behaviour

Annex

point

Year Title

Source (where

different from

company)

Company, Report

No.

GLP or GEP status

(where relevant)

Published or

Unpublished

Data

protection

claimed

Y/N

Owner Data

protection

granted

Y/N

Studies

relied

on

IIIA 9.6.1/01

2014a Predicted Environmental Concentrations of Sulfoxaflor (as product GF-2626) and its metabolites in groundwater using the FOCUS PEARL 4.4.4 and FOCUS PELMO 5.5.3 groundwater scenarios.

Exponent International Ltd. Report No.: 1402547.UK0-3433

Non-GLP, unpublished

Y Dow agroscience

N Y


GF-2626


Annex

point

Year Title

Source (where

different from

company)

Company, Report

No.

GLP or GEP status

(where relevant)

Published or

Unpublished

Data

protection

claimed

Y/N

Owner Data

protection

granted

Y/N

Studies

relied

on

IIIA 9.7.1/01

2014b Predicted Environmental Concentrations of Sulfoxaflor (as product GF-2626) and its Metabolites in Surface Water using the TOXSWA GUI Model and the National Guidelines of The Netherlands

Exponent International Ltd. Report No.: 1402547.UK0-1383

Non-GLP, unpublished

Y Dow agroscience

N Y

Ecotoxicology


GF-2626


Annex

Point/

Reference

Number

Year Title

Source (where different from the

Company),



relevant),

Published or not

Data

Protection

claimed

(Y/N)

Study

relied

on

(Y/N)

Owner Data

protection

granted

Y/N

IIIA 10.1.6/01

2011 GF-2626: An Acute Oral Toxicity Study with the Northern Bobwhite Using a Sequential Testing Procedure

Y Y DAS Y

DAS Report No.: 101304

GLP/GEP (Y/N): Y

Published (Y/N): N IIIA 10.2.2.1/01

2011a GF-2626: Acute Toxicity to the Rainbow Trout, Oncorhynchus

mykiss, Determined Under Static Test Conditions

Y Y DAS Y

DAS Report No.: 101909 Y GLP/GEP (Y/N): Y


2011b GF-2626: Acute Toxicity to the Water Flea, Daphnia magna, Determined Under Static Test Conditions

Y Y DAS Y

ABC Laboratories Inc., Columbia, Missouri, USA

DAS Report No.: 101910 Y GLP/GEP (Y/N): Y


2011 GF-2626: Growth Inhibition Test with the Freshwater Diatom, Navicula pelliculosa

Y Y DAS Y



GLP/GEP (Y/N): Y


2011c GF-2626: Acute Toxicity Test with the Mysid Shrimp, Americamysis

bahia, Determined Under Static-Renewal Conditions

Y Y DAS Y



GLP/GEP (Y/N): Y


2010 GF-2626: Acute 96 Hour Toxicity to the Midge, Chironomus dilutus, Determined Under Static Test Conditions

Y Y DAS Y




GF-2626


Annex

Point/

Reference

Number

Year Title


Company),



relevant),

Published or not

Data

Protection

claimed

(Y/N)

Study

relied

on

(Y/N)

Owner Data

protection

granted

Y/N

GLP/GEP (Y/N): Y


2010a Laboratory bioassay to determine the acute oral toxicity of GF-2626 to the honeybee, Apis mellifera

Y Y DAS Y

Mambo-Tox Ltd., Southampton, UK.

DAS Report No.: DOW-10-11 GLP/GEP (Y/N): Y


2010b Laboratory bioassay to determine the acute contact toxicity of GF-2626 to the honeybee, Apis mellifera

Y Y DAS Y


DAS Report No.: DOW-10-10 GLP/GEP (Y/N): Y

Published (Y/N): N IIIA 10.4.3/01

2008 GF-2032: Toxicity of Residues on Foliage to the Honeybee, Apis

mellifera

Y Y DAS Y


DAS Report No.: 080082 GLP/GEP (Y/N): Y


2011a Study on the Effect of GF-2626 on Honey Bee Brood (Apis mellifera L.) under Semi-Field Conditions - Tunnel Test

Y Y DAS Y

Institut fur Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany


GLP/GEP (Y/N): Y


2011b Study on the Effect of GF-2626 on Honey Bees and their Brood (Apis

mellifera L.) under Semi-Field Conditions

Y Y DAS Y



Published (Y/N): N


GF-2626


Annex

Point/

Reference

Number

Year Title


Company),



relevant),

Published or not

Data

Protection

claimed

(Y/N)

Study

relied

on

(Y/N)

Owner Data

protection

granted

Y/N

IIIA 10.4.7/03

2011c Toxicity Testing of GF-2626 on Honey Bees (Apis mellifera L.) under Semi-Field Conditions - Tunnel Test

Y Y DAS Y




2011 A Semi-field Study to Investigate Residues in Honeybee Products

(Apis mellifera carnica L.; (Hymenoptera, Apidae) in Phacelia

tanacetifolia in Germany in 2010.

Eurofins Agroscience Services GmbH Eutinger Str. 24 D-75223 Niefern-Öschelbronn Germany

DAS Study ID: 110414

GLP/GEP (Y/N): Y

Published (Y/N): N

Y Y DAS Y

IIIA 10.4.7/05

2016 Pre-Flowering Applications of Sulfoxaflor: Exposure and Effects on Honey bees

Dow AgroSciences

DAS Study ID: -

GLP/GEP (Y/N): n.a.

Published (Y/N): N

Y Y DAS Y

IIIA 10.5.1/01

2010a A rate-response laboratory test to determine the effects of GF-2626 on the parasitic wasp, Aphidius

rhopalosiphi (Hymenoptera: Braconidae).

Y Y DAS Y

Mambo-Tox Ltd

DAS Report No.: 10-13, 101308

GLP/GEP (Y/N): Y


2010a A rate-response laboratory test to determine the effects of GF-2626 on the predatory mite, Typhlodromus pyri (Acari: Phytoseiidae).

Y Y DAS Y

Mambo-Tox Ltd

DAS Report No.: 10-12, 101307 GLP/GEP (Y/N): Y

Published (Y/N): N


GF-2626


Annex

Point/

Reference

Number

Year Title


Company),



relevant),

Published or not

Data

Protection

claimed

(Y/N)

Study

relied

on

(Y/N)

Owner Data

protection

granted

Y/N

IIIA 10.5.2/01

2010b A rate-response extended laboratory bioassay to determine the effects of GF-2626 on the parasitic wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae).

Y Y DAS Y

Mambo-Tox Ltd.

DAS Report No.: 10-29, 101886 GLP/GEP (Y/N): Y


2009 An extended laboratory test to determine the effects of fresh residues of GF-2032 on the rove beetle, Aleochara bilineata (Coleoptera; Staphylinidae).

Y Y DAS Y

Mambo-Tox Ltd.



20011 A rate-response extended laboratory test to determine the effects of GF-2626 on the green lacewing, Chrysoperla carnea (Neuroptera, Chrysopidae).

Y Y DAS Y

Mambo-Tox Ltd.


GLP/GEP (Y/N): Y


2011 An aged-residue extended laboratory test to determine the effects of GF-2626 on the parasitic wasp, Aphidius

rhopalosiphi (Hymenoptera, Braconidae).

Y Y DAS y



GLP/GEP (Y/N): Y


2011a A “terrestrial mesocosm study” to assess the effects of GF-2626 (a 12 % SC formulation of XDE-208) on the non-target, surface- and plant-dwelling arthropod fauna of a grassland habitat in SW France, when exposed to low concentrations during spring.

Y Y DAS Y

Mitox, Amsterdam, the Netherlands.



GF-2626


Annex

Point/

Reference

Number

Year Title


Company),



relevant),

Published or not

Data

Protection

claimed

(Y/N)

Study

relied

on

(Y/N)

Owner Data

protection

granted

Y/N

GLP/GEP (Y/N): Y


2011 A field trial to determine the effects of GF-2372 (a 50% WG formulation of XDE-208) on the non-target arthropod fauna of arable land after one and two applications to a wheat crop South West France.

Y Y DAS Y




2011b A field trial to determine the effects of GF-2372 (a 50% WG formulation of XDE-208) on the non-target arthropod fauna of arable land after one and two applications to a wheat crop in the Netherlands.

Y Y DAS Y




2010a Determination of Acute Toxicity of GF-2626 to the Earthworm Eisenia

fetida in an Artificial Soil substrate.

Y Y DAS Y



GLP/GEP (Y/N): Y


2010b Determination of Chronic (Sub-lethal) Toxicity of GF-2626 to the Earthworm Eisenia fetida in an Artificial Soil substrate.

Y Y DAS Y




2012 Field Study to Evaluate the Effects of XDE-208 (as GF-2626 12% SC formulation) and its primary soil metabolite X11719474 on Earthworms in Southern Germany

Y Y DAS Y

Eurofins Agroscience Services GmbH,Niefern-Oschelbronn, Germany



GF-2626


Annex

Point/

Reference

Number

Year Title


Company),



relevant),

Published or not

Data

Protection

claimed

(Y/N)

Study

relied

on

(Y/N)

Owner Data

protection

granted

Y/N

GLP/GEP (Y/N): Y


2010 GF2626: Effects of GF-2626 on Reproduction of the Collembola Folsomia candida in Artificial soil with 5% Peat.

Y Y DAS Y




2011 GF2626: Effects of GF-2626 on Reproduction of the Predatory Mite Hypoaspis aculeifer in Artificial soil with 5% Peat.

Y Y DAS Y



Published (Y/N): N

IIIA 10.6.6/03

2012 Field Study to Evaluate the Effects of XDE-208 (as GF-2626 12% SC formulation) and its primary soil metabolite X11719474 on Soil Micro-Arthropods in Southern Germany

Eurofins Agroscience Services,EcoChem GmbH, Eutinger Str. 24, D-75223 Niefern-Öschelbronn, Germany

Y Y DAS Y



2011 Field Study to Evaluate the Effects of XDE-208 (as GF-2626 12% SC formulation) and its primary metabolite X11719474 on the Decomposition of Organic Matter in the Field.

Y Y DAS Y

Eurofins AgroScience Services GnbH., Niefern-Oschelbronn, Germany


Published (Y/N): N


GF-2626


Annex

Point/

Reference

Number

Year Title


Company),



relevant),

Published or not

Data

Protection

claimed

(Y/N)

Study

relied

on

(Y/N)

Owner Data

protection

granted

Y/N

IIIA 10.7.1/01

2011 Effects of GF-2626 on the Activity of the Soil Microflora in the Laboratory.

Y Y DAS Y


DAS Report No.: 101912 and 101917

GLP/GEP (Y/N): Y


2011a Evaluation of the Phytotoxicity of GF-2626 (Sulfoxaflor, 120 g as/l, SC) GLP Vegetative Vigour Test Terrestrial Non Target Plants (based on OECD Guideline 227) – Europe, 2011

Y Y DAS Y

Stockbridge Technology Centre Ltd., Cawood, Selby, North Yorkshire, UK



2011b Evaluation of the Phytotoxicity of GF-2626 (Sulfoxaflor, 120 g as/l, SC) GLP Seedling Emergence and Seedling Growth Test Terrestrial Non-Target Plants (Based on OECD Guideline 208) – Europe, 2011

Y Y DAS Y

Stockbridge Technology Centre Ltd., Cawood, Selby, North Yorkshire, UK


GLP/GEP (Y/N): Y

Published (Y/N): N


GF-2626


Data point

Year Title

Company Report No.

Source (where different from company)

GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

DOW =

DOW

Agrosciences

Data

protection

claimed

Y/N

Data

protection

granted Y/N

Study relied

on

Y/N

IIIA 10.3.1/01

2017a Determination of Residues of Sulfoxaflor in Nectar and Pollen of Apple after one Application of GF-2626 in a Semi-Field Residue Study with Honeybees (Apis mellifera L.) in Central and Southern Europe 2016; Eurofins Agroscience Services EcoChem GmbH / Eurofins Agroscience Services Ecotox GmbH, Niefern-Öschelbronn, Germany; Lab Study No. S16-00603; DAS Study No. 160356; 05 May 2017; Unpublished

N DOW Y Y Y

IIIA 10.3.1/02

2017b Determination of Residues of Sulfoxaflor in Nectar and Pollen of Strawberry Plants after one Application of GF-2626 in a Semi-Field Residue Study with Bumblebees (Bombus

terrestris L.) in Central and Southern Europe 2016; Eurofins Agroscience Services EcoChem GmbH / Eurofins Agroscience Services Ecotox GmbH; Lab Study No. S16-00602-L1; DAS Study No. 160355; Study finalization date: 05 May 2017; Unpublished

N DOW Y Y Y


GF-2626


Data point

Year Title

Company Report No.

Source (where different from company)

GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

DOW =

DOW

Agrosciences

Data

protection

claimed

Y/N

Data

protection

granted Y/N

Study relied

on

Y/N

IIIA 10.3.1/03

2017c Determination of Residues of Sulfoxaflor in Nectar and Pollen of Pumpkin after one Application of GF-2626 in a Semi-Field Residue Study with Honeybees (Apis mellifera L.) in Central and Southern Europe 2016; Eurofins Agroscience Services EcoChem GmbH / Eurofins Agroscience Services Ecotox GmbH, Niefern-Öschelbronn, Germany; Lab Study No. S16-00596; DAS Study No. 160354; 05 May 2017; Unpublished

N DOW Y Y Y

IIIA 10.3.1/04

2017d Residues of Sulfoxaflor in Nectar and Pollen of Winter Oil Seed Rape after one Application of GF-2372 in a Semi-Field Residue Study with Honeybees (Apis mellifera L.) in Germany 2016; Eurofins Agroscience Services EcoChem GmbH / Eurofins Agroscience Services Ecotox GmbH, Niefern-Öschelbronn, Germany; Lab Study No. S16-00604; DAS Study No. 160357; 06 May 2017; Unpublished

N DOW Y Y Y

Efficacy

Annex

Point

Report

Date

Title Source Company

Report No.

GLP/

GEP

Y/N

Data

Protection

Claimed

Y/N

Study

used?

Data

Protection

granted

Y/N

Owner


GF-2626


IIIA 6.1 2007

IPM Case studies: Cucurbits. in Aphids as

Crop Pests, ed. by van Emden H and Harrington R.

CABI Wallingford, UK. pp. 639-649

N N

Y

N Open literature

IIIA 6.1 1998

Occurrence, Distribution, and Relative Incidence of Mosaic Viruses Infecting Field-Grown Melon in Spain

Plant Disease 82. pp. 979-982

N N

Y

N Open literature

IIIA 6.1 1989 An estimate of the potential economic losses to some crops to aphids

Crop Protection 8. pp. 25-29.

N N Y

N Open literature

IIIA 6.1 1991

Simulation of damage in winter wheat caused by the grain aphid Sitobium avenae. 3. Calculation of damage at various sustainable yield levels.

European Journal of Plant Pathology. 97. pp. 87-103.

N N

Y

N Open literature

IIIA 6.1.1.2

1955 Tests with acaricides against the brown wheat mite.

J. Econ. Entomol. 48 , pp. 157–161

N N Y

Y Open literature

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA

1925 A method of computing the effectiveness of an insecticide..

J. Econ. Entomol.; 18 : 265-267

N N

y

N Open literature


GF-2626


6.2.8.7

IIIA 6.1.1.1 IIIA 6.2.8.6

2007

Early stage characterization of XDE-208 in Discovery Insect Biology evaluation programs

Dow AgroSciences

259319 Y Y

Y

Y Dow AgroSciences

IIIA 6.2.8.5

2012

Differential metabolism of sulfoximine and neonicotinoid insecticides by Drosophila melanogaster monooxygenase CYP6G1

Pesticide Biochemistry and Physiology 103 (2012) 159–165

N N

Y

N Open literature

IIIA 6.2.8.5

2013

Mini Review,Sulfoxaflor and the sulfoximine insecticides: Chemistry, mode of actionand basis for efficacy on resistant insectsn

Pesticide Biochemistry and Physiology 107 (2013) 1-7

N N

Y

N Open literature

IIIA 6.1.1.1

2013 Fungicidal Asessement of X11422208 (Sulfoxaflor)

Dow AgroSciences

Y Y Y

Y Dow AgroSciences

IIIA 6.2.8 2011

Mutation of a nicotinic acetylcholine receptor b subunit is associated with resistance toneonicotinoid insecticides in the aphid Myzus persicae

BMC Neuroscience 2011, 12:51 http://www.biomedcentral.com/1471-2202/12/51

N N

Y

N Open literature


GF-2626


IIIA 6.2.8 2013

Detecting the presence of target site resistance to neonicotinoids and pyrethroids in Italian populations of Myzus

persicae

Correspondence to Emanuele Mazzoni, Institute of Entomology and Plant Pathology, Università Cattolica del Sacro Cuore, Via Emilia Parmense, 84. I‐29122 Piacenza, Italy.

N N

Y

N Open literature

IIIA 6.2.8.6

2013

Cross-resistance relationships of thesulfoximine insecticide Sulfoxaflor withneonicotinoids and other insecticides in thewhiteflies Bemisia

tabaci and Trialeurodes

vaporariorum

Accepted article published: 19 October 2012 Published online in Wiley Online Library: 30 November 2012(wileyonlinelibrary.com) DOI 10.1002/ps.3439

N N

Y

N Open literature

IIIA 6.2.8.6

2014

Cross-resistance relationships of the sulfoximine insecticide Sulfoxaflor with pyrethroid, organophosphate, carbamate and

Dow AgroSciences SAGE Report

N Y

Y

Y Dow AgroSciences


GF-2626


neonicotinoid insecticides in the peach-potato aphid Myzus persicae.

IIIA 6.2.8 IIIA 6.2.8.6

2014

Baseline susceptibility and cross-resistance in Aphis

gossypii Glover (Aphididae:Hemiptera) to phorate and Sulfoxaflor

NSW DPI,EMAI,PMB 4008,Narellan,NSW 2567,Australia Austral Entomology (2014) 53,32-35

N N

Y

N Open literature

IIIA 6.2.8 2013 Knock –down resistance (kdr) in Grain Aphids

Insecticide Resistance Action Group ,UK.

N N

Y

N Open literature

IIIA 6.2.8.9

2013

Amutation (L1014F) in the voltage-gated sodium channel of the grain aphid, Sitobion avenae, is associated with resistance to pyrethroid insecticides

SCI (wileyonlinelibrary.com) DOI 10.1002/ps.3683

N N

Y

N Open literature

IIIA 6.1.2.1 IIIA 6.1.3.1

2008 Developing climatic scenarios for pesticide fate modelling in Europe.

Environmental Pollution 154., PP : 219-231

N N

N

N Open literature

IIIA 6.2.8.7

2014

Identification of R81T nAChR beta subunit mutation in field-collected strains of Myzus persicae

Dow AgroSciences

Y Y

y

Y Dow AgroSciences


GF-2626


from southern Europe

IIIA 6.1.1.1

2011

Speed of action of Sulfoxaflor on aphid feeding: Inhibition of honeydew production.

Dow AgroSciences

2008723 Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1

1997

Pymetrozine, a fast-acting and selective inhibitor of aphid feeding. In-situ studies with electronic monitoring of feeding behavior

Pesticide Science 49(2), 130-140

N N

Y

N Open literature

IIIA 6.1.1.1

2011

Translaminar activity of Sulfoxaflor in laboratory leaf paint bioassays on the green peach aphid Myzus persicae.

Dow AgroSciences

TBC Y Y

Y

Y Dow AgroSciences

IIIA 6.5.1 2014

Residual Activity of Sulfoxaflor in Laboratory Rain Fast Bioassays on the Green Peach Aphid, Myzus persicae

Dow AgroSciences

TBC Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.2

2008 XR-208 EFFICACY against aphids in winter barley.

Dow AgroSciences

HU07X03017PH01

Y Y Y

Y Dow AgroSciences

IIIA 6.1.1.2

2010

Comparison of GF-2032 240 SC with Movento 240 SC and Chess 500 WG for the control of cotton aphid

Dow AgroSciences

2007893 Y Y

y

Y Dow AgroSciences


GF-2626


(Aphis gossypii) and the prevention of mosaic virus in cucumbers cv. Redlands Long White. Bowen, Queensland, 2010

IIIA 6.1.1.1

2007

Flonicamid, a novel insecticide with a rapid inhibitory effect on aphid feeding.

Pest Management Science, 63(10), 969-973

N N

Y

N Open literature

IIIA 6 IIIA 6.2.8.5

2011 Novel nicotinic action of the sulfoximine insecticide Sulfoxaflor

Ins Biochem Mol Biol in press

N N Y

N Open literature

IIIA 6 IIIA 6.2.8.4

2011

Discovery and Characterization of Sulfoxaflor, a Novel Insecticide Targeting Sap-Feeding Pests.

J Agric Food Chem 59: 2950–2957

N N

Y

N Open literature

IIIA 6.1.1.1 IIIA 6.2.7

2008 Crop safety of XDE-208 Dow AgroSciences

259318 Y Y Y

Y Dow AgroSciences

IIIA 6.2.7 2011

Effects of GF-2626 on the Seedling Emergence of Non Target Terrestrial Plants

Stockbridge Technology Centre Ltd Cawood Selby North Yorkshire, UK YO8 3TZ

Y Y

Y

Y Dow AgroSciences


GF-2626


IIIA 6.2.7 2011 Effects of GF-2626 on the Vegetative Vigour of Non Target Terrestrial Plants.

Stockbridge Technology Centre Ltd Cawood Selby North Yorkshire, UK YO8 3TZ

Y Y

Y Dow AgroSciences

IIIA 6.2.8.6

2011 Biological characterization of Sulfoxaflor, a novel insecticide.

Pest Manag Sci 67: 328–334

N N Y

N Open literature

IIIA 6.2.8.5

2002 A single P450 allele associated with insecticide resistance in Drosophila.

Science 2002, 297, 2253-2256

N N Y

N Open literature

IIIA 6.2.8.5

2002

EPPO, Efficacy evaluation of plant protection products – Resistance risk analysis.

PP 1/213(2) pp. 76-93

N N

Y

N Open literature

IIIA 6.2.8.7

2009

Lab evaluation of the efficacy of the experimental product “XDE-208” against the green peach aphid and the cotton aphid (2008).

Dow AgroSciences

2001358 Y Y

Y

Y Dow AgroSciences

IIIA 6.2.8.7

2011

Evaluation of the efficacy of the experimental product “GF-2032” against the green peach aphid and the cotton aphid (REPORT 2010)

Dow AgroSciences

2008534 Y Y

Y

Y Dow AgroSciences


GF-2626


IIIA 6.2.8.7

2013

Evaluation of the activity of GF-2626 against different populations of aphids and whiteflies collected in several parts of Europe (Spain, Italy, France and Greece).

Dow AgroSciences

Y Y

Y

Y Dow AgroSciences

IIIA 6.2.8.6

2010

Bioassays and management of cotton aphids with neonicotinoids and Sulfoxaflor.

Proc Beltwide Cotton Conf 2010, pp 1207-1210

N N

Y

N Open literature

IIIA 6.2.8.9

2013

Cotton Aphid (Heteroptera: Aphididae) Susceptibility to Commercial and Experimental Insecticides in the Southern United States

Journal of Economic Entomology,Vol.106,no3 (June 2013)pp 1430-1439

N N

Y

N Open literature

IIIA 6.2.8.6 IIIA 6.2.8.9

2006

Whitefly/Aphid Cross Resistance Study Using Dow AgroSciences’ Experimental Insecticides at Rothamsted Research, United Kingdom. Stage three report.

Rothamsted Research, United Kingdom. Stage three report

2008457 Y Y

Y

Y Dow AgroSciences

IIIA 6.2.8.6 IIIA

2010 Activity of XDE208 against multi-resistant Hemipteran pests.

Rothamsted Research, United Kingdom.

2008458 Y Y y

Y Dow AgroSciences


GF-2626


6.2.8.9

IIIA 6 2010

IRAC (2010) IRAC MoA Classification Scheme (Version 7.0 October 2010).

http://www.irac-online.org/resources-2/document-library/

N N

Y

N Open literature

IIIA 6.2.8.5

2008

Metabolism of imidacloprid and DDT by P450 CYP6G1 expressed in cell cultures of Nicotiana tabacum suggests detoxification of these insecticides in Cyp6g1-overexpressing strains of Drosophila melanogaster, leading to resistance

Pest. Manag. Sci. 2008, 64, 65-73

N N

Y

N Open literature

IIIA 6.2.8.5

2008

Metabolism of imidacloprid and DDT by P450 CYP6G1 expressed in cell cultures of Nicotiana tabacum suggests detoxification of these insecticides in Cyp6g1-overexpressing strains of Drosophila melanogaster, leading to resistance.

Pest. Manag. Sci. 2008, 64, 65-73

N N

Y

N Open literature






GF-2626


IIIA 6.2.8.5

2008

Over-expression of cytochrome P450 CYP6M1 is associated with high resistance to imidacloprid in the B and Q biotypes of Bemisia tabaci (Hemiptera: Aleyrodidae).

Insect. Biochem. Molec. Biol. 2008, 38, 634-644.

N N

Y

N Open literature

IIIA 6.2.8.5

2010

Cytochrome P450 mono-oxygenase-mediated neonicotinoid resistance in the house fly Musca domestica L.

Pesticide Biochemistry and Physiology 98: 50–58

N N

Y

N Open literature

IIIA 6.2.8.5

2007

A Da6 knockout strain of Drosophila melanogaster confers a high level of resistance to spinosad

Insect Biochem. Mol. Biol. 37 (2), 184-188.

N N

Y

N Open literature

IIIA 6 IIIA 6.2.8.5

2012

Effects of mutations in the Drosophila nicotinic acetylcholine receptor subunits on sensitivity to insecticides targeting nicotinic acetylcholine receptors.

Pesticide Biochemistry and Physiology 102 (2012) 56–60

N N

Y

N Open literature

IIIA 6.2.8.5

2010

Metabolic enzyme(s) confer imidacloprid resistance in a clone of Myzus persicae (Sulzer) (Hemiptera: Aphididae)

Pest. Manag. Sci. 2010, 66, 390-395.

N N

y

N Open literature


GF-2626


from Greece.

IIIA 6.2.8.5

2010

Characterization of imidacloprid resistance mechanisms in the brown planthopper, Nilaparvata lugens Stål (Hemiptera: Delphacidae).

Pestic. Biochem. Physiol. 2010, 97, 129-132

N N

Y

N Open literature

IIIA 6 IIIA 6.2.8.5

2010

A spinosyn-sensitive Drosophila melanogaster nicotinic acetylcholine receptor identified through chemically induced target site resistance, resistance gene identification and heterologous expression.

Insect Biochemistry and Molecular Biology 40: 376-384

N N

Y

N Open literature

IIIA 6.2.8.5

2009

Imidacloprid resistance and its mechanisms in fleid populations of brown planthopper, Nilaparvata lugens Stål in China.

Pestici. Biochem. Physiol. 2009, 94, 36-42.

N N

Y

N Open literature

IIIA 6.1.2.7 IIIA 6.1.3.7

2013

What is the selectivity and efficacy of Sulfoxaflor against whiteflies in ornamentals?

Fondazione Minoprio

IT13C1C098ET01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.7 IIIA

2013 What is the selectivity and efficacy of Sulfoxaflor against whiteflies in

Fondazione Minoprio

IT13C1C098ET02C

Y Y y

Y Dow AgroSciences


GF-2626


6.1.3.7 ornamentals?

IIIA 6.1.2.7 IIIA 6.1.3.7

2008

Efficacy and selectivity of XDE-208 against whiteflies in ornamentals and flowers

Fondazione Minoprio

IT08C1C115ET01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.7 IIIA 6.1.3.7

2008

Efficacy and selectivity of XDE-208 against whiteflies in ornamentals and flowers

Fondazione Minoprio

IT08C1C118ET02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.7 IIIA 6.1.3.7

2012

What is the efficacy of Sulfoxaflor (GF-2626) against sap feeding pests in (solanaceous) ornamental crops?

Dow AgroSciences Italy

IT12C1C022LA01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.4 IIIA 6.1.3.4

2008 Efficacy and selectivity of XDE-208 against aphids in ornamentals and flowers

Fondazione Minoprio

IT08C1C109ET01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.4 IIIA 6.1.3.4

2011 Efficacy and selectivity of Sulfoxaflor for the control of aphids in ornamentals


IT11C1C007ET03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.4 IIIA 6.1.3.4

2011 Efficacy and selectivity of Sulfoxaflor for the control of aphids in ornamentals

Fondazione Minoprio

IT11C1C007ET05C

Y Y

Y

Y Dow AgroSciences


GF-2626


IIIA 6.1.2.4 IIIA 6.1.3.4

2012

What is the efficacy of Sulfoxaflor (GF-2626) against aphids in ornamentals

Fondazione Minoprio

IT12C1C013ET01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.4 IIIA 6.1.3.4

2012

What is the efficacy of Sulfoxaflor (GF-2626) against aphids in ornamentals


IT12C1C013ET03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.2

2008

What is the efficacy of XDE-208 (GF-2032) on aphids in broccoli and cauliflower in Spain?

Dow AgroSciences

ES08C1C015JM01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.2

2008


Dow AgroSciences

ES08C1C015MT01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.2

2008


Dow AgroSciences

ES08C1C015MT02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.2

2008


Recerca Agricola.

ES08C1C015MT03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.2

2008 Efficacy and selectivity of XDE-208 against aphids in brassicas

G.Z. S.R.L., IT IT08C1C107EET01

Y Y Y

Y Dow AgroSciences


GF-2626


IIIA 6.1.3.2

2008 Efficacy and selectivity of XDE-208 against aphids in brassicas

AGRI 2000, IT IT08C1C107ET02C

Y Y Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2011

What is the efficacy of Sulfoxaflor for the control of aphids in brassica vegetables. EU 2011

Eurofins, UK GB11C1C006SE01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2011


Eurofins, UK GB11C1C006SE02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2011


Eurofins, Germany

DE11C1C006AZ03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2011

What is the efficacy of Sulfoxaflor (GF-2626) for the control of aphids in brassica vegetables? EU 2011

Dow AgroSciences

IT11C1C006DC01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2011


Agri 2000 IT11C1C006ET1C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2011

What is the efficacy of Sulfoxaflor (GF-2626) for the control of aphids in brassica vegetables? EU

Proagri S.R.L IT11C1C006ET03C

Y Y

y

Y Dow AgroSciences


GF-2626


2011

IIIA 6.1.2.2 IIIA 6.1.3.2

2011


G.Z.S.R.L IT11C1C006ET04C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2011



Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2011


Dow AgroSciences

IT11C1C006ET06C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2012

What is the efficacy of Sulfoxaflor (GF-2626) against aphids in brassica crops?

Anadiag Italia SRL

IT12C1C014ET02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2012



Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2012


Agrolab IT12C1C014ET04C

Y Y

Y

Y Dow AgroSciences


GF-2626


IIIA 6.1.2.2 IIIA 6.1.3.2

2012


Dow AgroSciences

IT12C1C014LA01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2013


Dow AgroSciences

IT12C1C014ET01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.2 IIIA 6.1.3.2

2013


Dow AgroSciences

IT12C1C014AF01

Y Y

Y Y

Dow AgroSciences

IIIA 6.1.2.3 IIIA 6.1.3.3

2011

What is the efficacy of Sulfoxaflor for the control of aphids in potatoes.EU 2011

EUROFINS, UK GB11C1C011SE01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.3 IIIA 6.1.3.3

2012

What is the efficacy of Sulfoxaflor for the control of aphids in potatoes.EU 2012

AGRARTEST, DE

DE12C1C015AZ02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.3 IIIA 6.1.3.3

2012 Efficacy of Sulfoxaflor (GF-2626) against aphids in potatoes. Europe, 2012

ANADIAG FRANCE

FR12C1C015CR04C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.3 IIIA 6.1.3.3

2012 Efficacy of Sulfoxaflor (GF-2626) against aphids in potatoes. Europe, 2012

Dow AgroSciences

FR12C1C015FO01

Y Y

Y

Y Dow Agrosciences


GF-2626


IIIA 6.1.3.3 IIIA 6.2.1.3

2008 Efficacy of XDE-208 on aphids in potato crop. Europe, Spring 2008.

Dow AgroSciences

FR08C1C069YL02

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.3 IIIA 6.1.3.3 IIIA 6.2.1.3

2008

What is the comparative efficacy of XR 208 when applied for the control of aphids in potato. UK 2008

Dow AgroSciences

GB08C1C083SD01

Y Y

Y

Y Dow Agrosciences

IIIA 6.1.2.3 IIIA 6.1.3.3 IIIA 6.2.1.3

2008


Dow AgroSciences

GB08C1C083SE01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.3 IIIA 6.1.3.3 IIIA 6.2.1.3

2008


DEWAR CROP PROTECTION, UK

GB08C1C083SE02C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.3.3 IIIA 6.2.1.3

2008

What is the efficacy of XDE 208 when applied for control of aphids in potato,Germany 2008

AGRARTEST, DE

DE08C1C121AZ01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.3 IIIA

2008 What is the efficacy of XDE 208 when applied for control of aphids in

AGRARTEST, DE

DE08C1C121AZ02C

Y Y y

Y Dow AgroSciences


GF-2626


6.2.1.3 potato,Germany 2008

IIIA 6.1.2.3 IIIA 6.2.1.3 IIIA 6.1.3.3

2010


ARMSTRONG FISHER LTD, UK

GB10C1C013SE02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.3 IIIA 6.2.1.3

2011

What is the efficacy of Sulfoxaflor for the control of aphids in potatoes ? EU.2011.

AGRARTEST, DE

DE11C1C011AZ01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.3 IIIA 6.2.1.3

2011


AGRARTEST, DE

DE11C1C011AZ03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.3 IIIA 6.2.1.3

2011


EUROFINS-GAB GMBH, DE

DE11C1C011AZ05C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.3 IIIA 6.2.1.3

2008 Efficacy of XDE-208 on aphids in potato crop. Europe, Spring 2008

STAPHYT, FR FR08C1C069CR05C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.3 IIIA 6.2.1.3

2012

Blattlaeuse als Vektoren-Kartoffeln 2012. Efficacy of GF-2626 against Aphids in SOLTU, registration trials, Germany 2012

LWK NRW DE12C1C043AZ01C

Y Y

y

Y Dow AgroSciences


GF-2626


IIIA 6.1.3.3 IIIA 6.2.1.3

2012

Blattlaeuse als Vektoren-Kartoffeln 2012. Efficacy of GF-2626 against Aphids in SOLTU, registration trials, Germany 2012

LWK NRW DE12C1C043AZ02C

Y Y

Y

y Dow AgroSciences

IIIA 6.1. 2011 http://faostat.fao.org/site/567/default.aspx#ancor

FAO (Food and Agriculture Organisation of the UN);

N N

Y

N

FAO (Food and Agriculture Organisation of the UN)

IIIA 6.1. 2000

Some epidemiological approaches to the control of aphid-borne virus diseases in seed potato crops in northern Europe,

Virus Research, Volume 71, Issues 1–2, November 2000, Pages 33-47, ISSN 0168-1702, 10.1016/S0168-1702(00)00186-6. (http://www.sciencedirect.com/science/article/pii/S0168170200001866)

N N

Y

N Open literature

IIIA 6.1.3.3

2011 Blattlausbekaempfung zum Schutz von Kartoffelviren

Kartoffelbau 5/2011 (62. Jg.)

N N Y

N Open literature

IIIA 6.1.3.3

2010 Bekaempfung von Blattlaeusen als Virusüberträger

Kartoffelbau 5/2010 (61. Jg.)

N N y

N Open literature

http://faostat.fao.org/site/567/default.aspx#ancor



GF-2626


IIIA 6.1.2.1

2008

What is the rate of Sulfoxaflor (GF-2032) needed to control aphids in legumes?

Zkusebni stanice Nechanice s.r.o.

CZ08C1C130KS01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2008


Agritec Research, Breeding and Services Ltd

CZ08C1C130KS02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2008


Vyzkumny ustav picninarsky, spol. S r.o.

CZ08C1C130KS03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.1

2008 Efficacy of XDE-208 against aphids in peas

NTSZ Hajdú-Bihar megye

HU08C1C130IM01C

Y Y Y

Y Dow AgroSciences

IIIA 6.1.2.1


NTSZ JNSZ megye

HU08C1C130IM02C

Y Y Y

Y Dow AgroSciences

IIIA 6.1.2.1


NTSZ Bekes megye

HU08C1C130IM03C

Y Y Y

Y Dow AgroSciences

IIIA 6.1.2.1

2012


Dow AgroSciences Hungary Kft.

HU12C1C016JP01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2012


Governmental Office, JNSZ

HU12C1C016JP03C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.2.1

2012 What is the rate of Sulfoxaflor (GF-2626)

BioTek Agriculture

HU12C1C016JP04C

Y Y Y

Y Dow AgroSciences


GF-2626


IIIA 6.2.1.1

needed to control aphids in legumes?

Hungary Ltd.

IIIA 6.1.2.1 IIIA 6.2.1.1

2012


Fejér Megyei KH NTI

HU12C1C016JP05C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2007 Greece : Efficacy of X11422208 against APHIPHA in vegetable.

Dow AgroSciences Export S.A.S.

GR07C1C005NK01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2007 Greece : Efficacy of X11422208 against MYZUPE in vegetable


GR07C1C005NK02

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2008 Efficacy of GF-2032 against Aphis spp. on vegetables.


GR08C1C056VA01

Y Y

Y

y Dow AgroSciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2008 Efficacy of XDE-208 on aphids in Vicia faba. Europe, Spring 2008.

Dow AgroSciences

FR08C1C069YC03

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2012

What is the rate of Sulfoxaflor (GF-2626) needed to control aphids in green beans?

Agricultura Y Ensayo S.L.

ES12C1C016MT03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.1


Agricultura Y Ensayo S.L.

ES12C1C016MT04C

Y Y Y

Y Dow AgroSciences


GF-2626


IIIA 6.2.1.1

needed to control aphids in green beans?

IIIA 6.1.2.1 IIIA 6.2.1.1

2013 Efficacy and selectivity of GF-2626 on aphids in horse bean

Fejér Megyei KH NTI

HU13C1C070JP01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.6

2007 XR-208 Efficacy against Myzus persicae and selectivity in peach

Dow Agrosciences Hungary Kft. Field Development Station, HU

HU07X03019IM01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.6

XR-208 efficacy against aphids in orchards

Dow Agrosciences Hungary Kft. Field Development Station,

HU07X03027IM02

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.6 IIIA 6.2.1.6

2008

What is the rate of Sulfoxaflor (GF-2032) needed to control aphids in stone fruit?

EVOKIN - Svaz integrovane a ekologicke produkce hroznu a vina o.s, CZ

CZ08C1C130KS04C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.6 IIIA 6.2.1.6

2008

What is the rate of Sulfoxaflor (GF-2032) needed to control aphids in cherry tree?

Zkusebni stanice Nechanice S.r.o., CZ

CZ08C1C194KS01C

Y Y

Y

Y Dow AgroSciences


GF-2626


IIIA 6.1.3.6 IIIA 6.2.1.6

2008 Effivcacy of XDE 208 against aphids in stone fruits.

NTSZ Heves megye, HU

HU08C1C124IM01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.6 IIIA 6.2.1.6

2009

What is the efficacy and selectivity of different Sulfoxaflor analogs against Myzus persicae and brachycaudus persicae in stone fruits?

NTSZ Fovaros es Pest megye, HU

HU09X03008IM01C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2011

What is they rate of Sulfoxaflor y(GF-2626) needed to control Myzus persicae and Brachycaudus persicae in peaches in Hungary?


HU11C1C004JP01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2011

What is the rate of Sulfoxaflor (GF-2626) needed to control Myzus persicae and Brachycaudus persicae in peaches in Hungary?

Csongrad County Agricultural Office, Plant Protection and Soil Conservation Directorate of Plant Protection and Quarantine Laboratory, HU

HU11C1C004JP02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.6

IIIA 2011

What is the rate of Sulfoxaflor (GF-2626) needed to control Myzus

BioTek Agriculture Hungary Kft.,

HU11C1C004JP03C

Y Y Y

y Dow AgroSciences


GF-2626


6.1.3.6 IIIA 6.2.1.6

persicae and Brachycaudus persicae in peaches in Hungary?

HU

IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2011

What is the rate of Sulfoxaflor (GF-2626) needed to control Myzus persicae and Brachycaudus persicae in peaches in Hungary?

SynTech Research Hungary Kft., HU

HU11C1C004JP04C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2011

What is the rate of Sulfoxaflor (GF-2626) needed to control aphids in stone in the Czech republic


CZ11C1C004KS01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2011

What is the rate of Sulfoxaflor (GF-2626) needed to control aphids in stone in the Czech republic


CZ11C1C004KS02C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2012

What is the rate of Sulfoxaflor (GF-2626) needed to control Myzus persicae and Brachycaudus persicae in peaches?


HU12C1C003JP01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.6


Dow Agrosciences

HU12C1C003JP02

Y Y y

Y Dow AgroSciences


GF-2626


IIIA 6.1.3.6 IIIA 6.2.1.6

needed to control Myzus persicae and Brachycaudus persicae in peaches?

Hungary Kft. Field Development Station, HU

IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2012

What is the rate of Sulfoxaflor (GF-2626) needed to control aphids in Stonefruits?

Uniwersytet Przyrodniczy Poznan, PL

PL12C1C003AS01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2012


Eurofins Agroscience Services, PL

PL12C1C003AS02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2012


Uniwersytet Przyrodniczy Lublin, PL

PL12C1C003AS03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2012


Uniwersytet Przyrodniczy Lublin, PL

PL12C1C003AS04C

Y Y

Y

Y Dow AgroSciences


GF-2626


IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2013 Efficacy of GF-2626 on early aphids in stone fruits, EU

ATC – Agro Trial Center GmbH, AT

DE13C1C035AZ01C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.2.6 IIIA 6.1.3.6 IIIA 6.2.1.6

2013 Efficacy of GF-2626 (3 rates) on early aphids in stone fruits, EU


HU13C1C035JP01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.6

2013

What is the efficacy of Sulfoxaflor (GF-2626) applied at 24 gai/ha as a single application and sequential and to evaluate the effect of peach green aphid

Research Institute for fruit growing – Pitesti Maracineni, RO

RO13C1C020AP02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.9 IIIA 6.1.3.9 IIIA 6.2.1.6

2013 Efficacy of GF-2626 on scales (3 rates) in stone fruit, EU

Government Office of County Borsod-Abaúj-Zemplén, Directorate of Plant Protection and Soil Conservation

HU13C1C036JP01C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.2.9

2013 What is the efficacy of Sulfoxaflor (GF-2626)

Research Institute for fruit

RO13C1C020AP01C

Y Y y

Y Dow AgroSciences


GF-2626


IIIA 6.1.3.9

applied at 24 gai/ha as a single application and sequential and to evaluate the effect of San-Jose scale

growing – Pitesti Maracineni, RO

IIIA 6.1.3.5

2008

Efficacy of XDE 208 against aphids (Aphis pomi/Dysaphis plantagina) in pome fruits

Dow AgroSciences Development Station,HU

HU08C1C123PH01

Y Y

Y

Y Dow Agrosciences

IIIA 6.1.3.5 IIIA 6.2.1.5

2008


NTSZ BACS-KISKUN MEGYE. HU

HU08C1C123IM03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.5 IIIA 6.2.1.5

2008


NTSZ BORSOD-ABAUJ-ZEMPLEN, HU

HU08C1C123IM02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.5 IIIA 6.2.1.5

2009 What is the efficacy and selectivity of different Sulfoxaflor analogs


HU09X03005PH01

Y Y

Y

y Dow AgroSciences

IIIA 6.1.3.5 IIIA 6.2.1.5

2011

What is the rate of Sulfoxaflor (GF-2626) needed to control the most important aphid species in pome fruits ?

Biotek Agriculture Hungary Kft.,HU

HU11C1C001JP03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5IIIA

2011

What is the rate of Sulfoxaflor (GF-2626) needed to control the most important aphid species in

BAZ megyei MGSZH-NTI,HU

HU11C1C001JP02C

Y Y

y

Y Dow AgroSciences


GF-2626


6.2.1.5 pome fruits ?

IIIA 6.1.2.5 IIIA 6.1.3.5IIIA 6.2.1.5

2011



HU11C1C001JP01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5IIIA 6.2.1.5

2012

Efficacy of Sulfoxaflor (GF-2626) on the most important aphid species in pome fruit

Biotek Agriculture Hungary Kft.HU

HU12C1C001JP02C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5

2012



HU12C1C001JP01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5IIIA 6.2.1.5

2011


SPACILOVA CZ11C1C001BKS01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2012



DE12C1C001AZ04C

Y Y

Y

Y Dow AgroSciences


GF-2626


IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2012



DE12C1C001AZ03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2008 Efficacy and selectivity of XR-208 on aphids in pome fruit, Germany 2008


DE08C1C120AZ01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.5

2008 Efficacy and selectivity of XR-208 on aphids in pome fruit, Germany 2008


DE08C1C120AZ02C

Y Y Y

Y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2012

Efficacy of Sulfoxaflor (GF-2626) on the most important aphid species in pome fruits.

Eurofins Agroscience Services Sp. z o.o. PL

PL12C1C001AS02C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.3.5 IIIA 6.2.1.5

2008


NTSZ Szabolcs-Szatmár-megye, HU

HU08C1C123IM01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.3.5

2007 XR-208 efficacy against aphids in orchards.


HU07X03027IM01

Y Y

Y

Y Dow Agrosciences


GF-2626


IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2012


Uniwersytet Przyrodniczy.,Poznan,PL

PL12C1C001AS01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5

2009

What is the comparative efficacy of XR-208 when applied for the control of aphids in apples and pears ?

PCFRUIT, BE GB08C1C077SE01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5

2009


PCFRUIT, BE GB08C1C077SE02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2008


Dow AgroSciences Europe,UK.

GB08C1C077PJ01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2008


Dow AgroSciences Europe,UK.

GB08C1C077DT01

Y N

Y

N Dow AgroSciences


GF-2626


IIIA 6.1. 2011 http://faostat.fao.org/site/567/default.aspx#ancor

FAO (Food and Agriculture Organisation of the UN);

N N

Y

N Open literature

IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2013

Mittelempfehlungen und Hinweise zum Pflanzenschutz im Kernobst 2013

Obstbau 3/2013, Beilagenheft, Stand 10. Februar 2013

N N

Y

n

Dienstleistungszentrum laendlicher Raum

IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2010 Utah Pests fact sheet

Utah state university extension, ENT-143-98, October 2010

N N

Y

N Utah state university extension

IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2012 Pennsylvania 2012-2013 Tree fruit production guide

http://extension.psu.edu/plants/tree-fruit/tfpg

N N

Y

N Pennsylvania State University

IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2013 Woolly aphid, Woolly apple aphid, American blight, Apple root aphid

http://www7.inra.fr/hyppz/RAVAGEUR/6erilan.htm

N N

Y

n INRA







GF-2626


IIIA 6.1.2.8 IIIA 6.1.3.8 IIIA 6.2.1.5

2013 Time for San Jose Scale

http://msue.anr.msu.edu/news/time_for_san_jose_scale

N N

Y

N MSU

IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2012 Apfelblutlaus (Eriosoma lanigerum)

DLR Rheinpfalz I 924.12 Neustadt 2012

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.2.5 IIIA 6.1.3.5 IIIA 6.2.1.5

2012 Blutlaus-Bekaempfungsversuch 2012

LRA Karlsuhe 2012; LRA Karlsruhe

Y Y

Y

y Dow AgroSciences

IIIA 6.1.2.8 IIIA 6.1.3.8 IIIA 6.2.1.5

2011

What is the rate of Sulfoxaflor (GF-2626) needed to control the most important scale species in pome fruits ?

ATC - Agro Trial Center GmbH

DE11C1C016AZ01C

Y Y

Y

Y Dow AgroSciences


2013 Efficacy of GF 2626 on scales (3 rates) in pome fruits (pear) EU.

ATC - Agro Trial Center GmbH

DE13C1C032AZ01C

Y Y

y

Y Dow AgroSciences


GF-2626


6.2.1.5

IIIA 6.1.2.8 IIIA 6.1.3.8 IIIA 6.2.1.5

2013 Efficacy of GF 2626 on scales (3 rates) in pome fruits (pear) EU.

BAZ megyei KH NTI.HU

HU13C1C032JP01C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2011

What is the rate of Sulfoxaflor (gf-2626) needed to control the most Important aphid species in lettuce?

i2L Research Ltd GB11C1C012SE03C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2011

What is the rate of Sulfoxaflor (gf-2626) needed to control the most Important aphid species in lettuce?

Dewar Crop Protection Ltd

GB11C1C012SE01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2008 What is the efficacy of X11422208 on aphids in vegetables in Spain?

Dow AgroSciences Ibérica SA (SP);

ES07X03006JM02

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA

2008 What is the efficacy of X11422208 on aphids in vegetables in Spain?


ES07X03006SC02

Y Y y

Y Dow AgroSciences


GF-2626


6.1.1.2 IIIA 6.1.1.3 IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2008

What is the efficacy of XDE-208 (GF-2032) on aphid populations in lettuce in Spain?

Agrotecnica del Sur, S.L. (SP);

ES08C1C013MT01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2008

What is the efficacy of XDE-208 (GF-2032) on aphid populations in lettuce?

Agrotfile (PT); PT08C1C013MT01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2008

What is the efficacy of XDE-208 (GF-2032) on aphid populations in lettuce?

Agrotfile (PT); PT08C1C013MT01C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2008 Efficacy of XDE-208 on aphids in lettuce crop. Europe, 2008.

SFR (FR); FR08C1C063CR02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1

2008 Efficacy of XDE-208 on aphids in lettuce crop.

Solevi (FR); FR08C1C063CR03C

Y Y y

Y Dow AgroSciences


GF-2626


IIIA 6.1.1.2 IIIA 6.1.1.3

Europe, 2008.

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2008 Efficacy of XDE-208 on aphids in lettuce crop. Europe, 2008.

Eurofins Agroscience ServiceSarl (FR)

FR08C1C063CR04C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2008

What is the rate of Sulfoxaflor (GF-2626) needed to control aphids in lettuce?


ES11C1C012JM01

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2008



ES11C1C012JM02

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2008

What is the rate of Sulfoxaflor (GF-2626) needed to control the most important aphid specie in lettuce?

Dow Agrosciences ITalia Srl (IT);

IT11C1C012AF01

Y Y

Y

y Dow AgroSciences


GF-2626


IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2011


ASTRA (IT); IT11C1C012ET01C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2011


Dow Agrosciences Italia Srl (IT);

IT11C1C012ET05C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2012


Métodos Servicios Agrícola S.A. (SP);

ES12C1C012MT01C

Y Y

Y

y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2012


Métodos Servicios Agrícola S.A. (SP);

ES12C1C012MT02C

Y Y

Y

Y Dow AgroSciences


2012



ES12C1C012SC02

Y Y

y

Y Dow AgroSciences


GF-2626


6.1.1.3

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2012



ES12C1C012SC03

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2012 Efficacy of Sulfoxaflor (GF-2626) against aphids in lettuce

Dow AgroSciences, Nimes (FR);

FR12C1C012JG02

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2012

What is the rate of Sulfoxaflor (GF-2626) needed to control the most aphid species in lettuce?

Agrobiocontrol (IT);

IT11C1C012ET02C

Y Y

Y

Y Dow AgroSciences

IIIA 6.1.1.1 IIIA 6.1.1.2 IIIA 6.1.1.3

2012

What is the rate of Sulfoxaflor (GF-2626) needed to control the most aphid species in lettuce?

Agrobiocontrol (IT);

IT11C1C012ET03C

Y Y

Y

Y Dow AgroSciences

Documents

HET COLLEGE VOOR DE TOELATING VAN ......HET COLLEGE BESLUIT tot uitbreiding van de toelating van bovenstaand middel. Alle bijlagen, waaronder registratierapport deel A en deel B, vormen