HET COLLEGE VOOR DE TOELATING VAN ......2015/08/29 · The Draft Assessment Report (DAR) on...

Part A

National Assessment - The Netherlands

CLOSER Registration Report - Central Zone

Netherlands

of 77

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 toelating 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 Frankrijk.

HET COLLEGE BESLUIT tot 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



Netherlands

of 77

� 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)

Niet van toepassing. Het betreft een nieuwe toelating.

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



Netherlands

of 77

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, 3 augustus 2018

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,

Ir. J.F. de Leeuw

Voorzitter

Part A



Netherlands

of 77

BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

2.1 Aanvraaginformatie

Aanvraagnummer: 20150829 NLTG

Type aanvraag: aanvraag tot nationale toelating

gewasbeschermingsmiddel (NL=CMS)

Middelnaam: CLOSER

Verzenddatum aanvraag: 29 april 2015

Formele registratiedatum: * 16 juni 2015

Datum in behandeling name: 1 februari 2018

Datum compliance check: n.v.t.

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

Aangezien CLOSER een voor Nederland nieuwe werkzame stof bevat (sulfoxaflor, zie hieronder), is de

zienswijzeprocedure zoals bedoeld in artikel 2:3 Besluit bestuursreglement regeling toelating

gewasbeschermingsmiddelen en biociden Ctgb 2007 toegepast. Er zijn geen zienswijzen ontvangen

binnen de daarvoor gestelde termijn.

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: Origineel

Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel

Gebruikers: Professioneel

2.4 Verpakkingsinformatie

Aard van het preparaat:

Suspensie concentraat

Part A



Netherlands

of 77

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 Nee

Voelbare gevaarsaanduiding verplicht Nee

Part A



Netherlands

of 77

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: France

NATIONAL ASSESSMENT - NL

Applicant DOW

AGROSCIENCES

Date June 2018

Evaluator Ctgb, NL

Part A



Netherlands

of 77

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

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

3 Risk management .................................................................................................................. 13

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform principles ................................................................................................................................... 13

3.1.1 Physical and chemical properties ............................................................................ 13

3.1.2 Method of analysis .................................................................................................. 13

3.1.3 Mammalian Toxicology .......................................................................................... 14

3.1.4 Residues and Consumer Exposure .......................................................................... 14

3.1.5 Environmental fate and behaviour .......................................................................... 15

3.1.6 Ecotoxicology .......................................................................................................... 16

3.1.7 Efficacy ................................................................................................................... 18

3.2 Conclusions ................................................................................................................... 26

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 ................................................... 28

Appendix 1 Copy of the product authorisation .......................................................................... 29

Appendix 2 Copy of the product label ....................................................................................... 29

Appendix 3 Letter of Access ...................................................................................................... 32

Part A



Netherlands

of 77

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.

1.2 EU Active Approval

Sulfoxaflor is a new active substance which is currently undergoing evaluation for active substance approval in the EU. Ireland (Pesticide Registration and Control Division, PRCD) is the rapporteur Member State (RMS). A dossier for the active substance was submitted by Dow AgroSciences, under Regulation (EC) 1107/2009, to the RMS in July 2011 with an application to obtain its approval in the EU. The active substance submission followed a zonal approach where the evaluation was shared by four Member States participating under a work-share umbrella as follows: Ireland - RMS, lead reviewer for the sections Toxicology, Residues and Metabolism along with coordination of the work-share project. France: Lead reviewer for the sections Identity/Physical-Chemical properties, Methods of Analysis and Efficacy/Biology. Poland: Lead reviewer for the section Environmental Fate. Czech Republic: Lead reviewer for the section Ecotoxicology. The Draft Assessment Report (DAR) on sulfoxaflor was finalised and distributed by Ireland in November 2012, with a recommendation for approval of the active substance according to Regulation (EC) 1107/2009. The EFSA peer review process was conducted and the EFSA conclusion was published in May 2014.

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 endpoints.

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.

Part A



Netherlands

of 77

2 Details of the authorisation

2.1 Product identity

Product Name CLOSER (GF-2626)

Authorisation Number (for re-registration)

Not available

Function Insecticide

Applicant Dow AgroSciences

Composition 120 g/L sulfoxaflor

Formulation type Suspension concentrate [Code: SC]

Packaging PET and HDPE

2.2 Classification and labelling

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 proposed by the applicant were granted. Other: -

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

Part A



Netherlands

of 77

2.3 Authorised uses

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

1a NL Fruiting vegetables

Aubergine (incl. pepinos)

Pepper (incl. Chili pepper)

Tomato

G Aphids

Aphis gossypii,

Myzus persicae

Ground applied foliar spray, broadcast

BBCH 20-87

Jan-Dec

1-2 (7) 0.066 - 0.2

0.008 – 0.024

0.024 -0.048

500-1500 1 Dose rate 0.013% (13 ml product / 100 L)

1 or 2 applications of maximum 0.024 kg a.s/ha.

Two applications would be minimum 7 days interval

a) 2 b) 0.4 L/ha

1b NL Fruiting vegetables

Aubergine (incl. pepinos)

Pepper (incl. Chili pepper)

Tomato

G Whitefly

Bemisia tabaci,

Trialeurodes vaporariorum


BBCH 20-87

Jan-Dec

1-2 (7) 0.132 -0.4

0.016 -0.048


Either 2 applications of 0.024 kg a.s./ha with a minimum 7 days interval or one application of 0.048 kg a.s./ha

a) 2 b) 0.4 L/ha

3a NL Cucurbits (edible peel

Cucumbers,

Courgettes,

Gherkins

G Aphids

Aphis gossypii,

Myzus persicae


BBCH 20-87

Jan-Dec

1-2 (7) 0.066 - 0.2

0.008 – 0.024

0.024 -0.048




a) 2 b) 0.4 L/ha

Part A



Netherlands

of 77

3b NL Cucurbits (edible peel

Cucumbers,

Courgettes,

Gherkins

G Whitefly

Bemisia tabaci,



BBCH 20-87

Jan-Dec

1-2 (7) 0.132 -0.4

0.016 -0.048



a) 2 b) 0.4 L/ha

4a NL Cucurbits (inedible peel

Melons,

Pumpkins/squash,

Zucchini,

Watermelons

G Aphids

Aphis gossypii,

Myzus persicae


BBCH 20-87

Jan-Dec

1-2 (7) 0.066 - 0.2

0.008 – 0.024

0.024 -0.048




a) 2 b) 0.4 L/ha

4b NL Cucurbits (inedible peel

Melons,

Pumpkins/squash,

Zucchini,

Watermelons

G Whitefly

Bemisia tabaci,



BBCH 20-87

Jan-Dec

1-2 (7) 0.132 -0.4

0.016 -0.048



a) 2 b) 0.4 L/ha

5a NL Floriculture crops

G Aphids

Aphis gossypii,

Myzus persicae,

Macrosiphum euphorbiae


BBCH 12-59

Jan-Dec

1-2 (7) 0.066 - 0.2

0.008 – 0.024

0.024 -0.048

500 – 1500

1 Dose rate 0.013% (13 ml product / 100 L)



a) 2 b) 0.4 L/ha

5b NL Floriculture crops

G Whitefly

Bemisia tabaci,

Trialeurodes

Ground applied foliar spray,

BBCH 12-59

Jan-Dec

1-2 (7) 0.132 -0.4

0.016 -0.048

500 – 1500

1 Dose rate 0.026% (26 ml product / 100 L)

Either 2 applications of 0.024 kg a.s./ha with a minimum 7 days

Part A



Netherlands

of 77

vaporariorum broadcast interval or one application of 0.048 kg a.s./ha

a) 2 b) 0.4 L/ha

Part A



Netherlands

of 77

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 1107/2009.

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. 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. Accelerated stability data after 2 weeks at 54 °C and 8 weeks 40°C 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 (in application CLOSER 20140290 NLTG field uses). 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. The technical properties are acceptable to the intended use of the SC-formulation.

Implications for labelling: None.

Tank 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.

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

Part A



Netherlands

of 77

3.1.2.2 Analytical method for the residues

Analytical methods 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

The acute toxicity package is addressed in the core dossier. In short, CLOSER has a low toxicity in respect to acute oral, inhalation and dermal toxicity and is not irritating to the rabbit skin or eye and is not a skin sensitiser.

3.1.3.2 Operator Exposure

CLOSER containing 120 g/L sulfoxaflor is intended to be used as an insecticide on a range of crops grown in greenhouses. The proposed uses have been evaluated using the Dutch Greenhouse Model in a national addendum using a default dermal absortion value of 75%.

Predicted exposures for handheld applications to crops are 18% of the AOEL for sulfoxaflor assuming the operator wearsPPE (gloves).

3.1.3.3 Bystander Exposure

GF-2626 is applied in indoor professional facicities and bystanders should not be present during application. Terefore, there is no undue risk for the bystander.

The recommended uses of CLOSER may potentially result in brief, incidental exposure of residents to diluted water-based spray drift, but the extent of exposure is considered to be minimal and effectively represents no adverse risk.

3.1.3.4 Worker Exposer

The worker exposure assessment was assessed in the core. A safe use was concluded for the unprotected workers wearing workwear (but no PPE) during re-entry activities.

3.1.4 Residues and Consumer Exposure

3.1.4.1 Residues

The stability of residues and metabolism in primary crops were sufficiently investigated in the Annex I inclusion process. No new data were submitted. Data on metabolism in animals or livestock feeding studies are not required.

Regarding the magnitude of residues in the intended crops, a sufficient number of supervised residue trials were submitted to support the intended indoor use in the Netherlands. These data allowed to estimate the expected residue concentration in the

Part A



Netherlands

of 77

relevant crops and to confirm that no MRLs, as laid down in Regulation (EU) 2017/405, are expected to be exceeded.

The nature of residues during processing was sufficiently assessed during the Annex I inclusion process; no new studies were submitted. New data about the distribution of residues in peel and pulp were submitted, however, they were regarded informative only. Consequently no transfer factors were established.

Data on residues in rotational crops were sufficiently assessed during the Annex I inclusion. No risk mitigation measures are required provided that the product is used 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). Based on the highest recommended use of a single application of 48 g a.s./ha in ornamentals, at an interception of 10%, the maximum initial predicted environmental concentration in soil (PECsoil) of sulfoxaflor is 0.0576 mg/kg. Due to its low persistence, no plateau value was calculated. For the major soil metabolites X11719474 and X11519540, PECsoil values were 0.0610 and 0.0064 mg/kg, respectively. Respective PECaccu values were 0.127 and 0.032 mg/kg. 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 scenarios using the FOCUS PEARL 4.4.4 model (outdoor uses have been used as a surrogate for indoor uses). The modelling undertaken in this exercise was based

Part A



Netherlands

of 77

on the GAP requested (Winter cereals, 25% interception, 1 x 48 g a.s./ha, 25th May) and using the endpoints as in the EFSA conclusion (2014).

The PECgw for sulfoxaflor was < 0.001 µg/l. For the three non-relevant metabolites, the values were above 0.1 µg/l (i.e., 3.29, 1.29, and 2.06 for X11719474, X11519540 and X11579457, respectively). However, according to Part B Section 8, Core document, all three metabolites are considered not-relevant (based on PECGW values of 8.38, 3.74, and 5.92 µg/l for X11719474, X11519540, and X11579457, respectively).

There are no data available regarding the presence of the active substance in groundwater in the Netherlands.

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 the metabolites X11719474 and X11519540 in surface water has been assessed In accordance with the standard Dutch glasshouse model. A loss of 0.1% of the active substance to the standard surface water body was assumed.

After spring or autumn application, the initial maximum PECsw value for sulfoxaflor was 0.023 µg/l. The corresponding value for the surface water-relevant metabolite X11719474 was 0.017 µg/l. PECSEDs were 0.0003 and 0.0002 mg/kg for parent and metabolite, respectively.

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

There are no data available in the Pesticide Atlas regarding the presence of the substance in surface water.

As sulfoxaflor is a new active substance, there are no data available regarding its presence in surface water at drinking water abstraction points.

The decision tree as outlined in Alterra report 1635 (2010) and the tool DROPLET (described in Alterra report 2020, 2010), are used to calculate concentrations on drinking water abstraction points following field application. However, they are not suitable for greenhouse uses, since the area of use is not available in DROPLET. Therefore the assessment is made analogously to the interim decision tree. The PIEC in the edge-of-field ditch according to TOXSWA-NL is used as a basis for further calculations. A dilution factor of 10 and a travelling time of 14 days is taken into account to predict the concentration at the drinking water abstraction point.

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 unlikely to cause risk.

3.1.6 Ecotoxicology

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

Part A



Netherlands

of 77

Birds and mammals

The uses of GF-2626 on fruiting vegetables and ornamentals grown under protection will not lead to significant exposure of natural populations of birds and mammals, thus the risk to this wildlife group is considered to be negligible.

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

Dutch specific assessment

The risk to aquatic organisms was assessed based on the Aquatic Guidance Document (Sanco/ 3268/2001) using initial aquatic PEC values calculated in accordance with the standard Dutch glasshouse model.

An acceptable risk to aquatic organisms has been demonstrated for the indoor uses of GF-2626 on fruiting vegetables and ornamentals, without the need for risk mitigation measures.

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

and 10.5)

Effects on bees

The risk to bees is acceptable when the following sentences are placed on the label:

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 leveranciers van bestuivers en van 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”.

Effects on other non-target arthropod species

The uses of GF-2626 on fruiting vegetables and ornamentals grown under protection will not lead to significant exposure of natural populations of non-target arthropods, thus the risk to this wildlife group is considered to be negligible.

According to the IPM decision tree, based on effects on Aphidius rhopalosiphi a warning phrase must be included on the label to prevent unacceptable effects on natural enemies: ‘Attention: this product can be harmful for natural enemies. Seek consultation with your supplier of natural enemies about the use of this product in combination with natural enemies.’

Let op: dit middel kan schadelijk zijn voor bestuivers en natuurlijke vijanden in

kasteelten. Raadpleeg deskundigen (uw leveranciers van bestuivers en van 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”.

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

Part A



Netherlands

of 77

Point 10.6)

The uses of GF-2626 on fruiting vegetables and ornamentals grown under protection will not lead to significant exposure of soil organisms, thus the risk to this wildlife group is considered to be negligible.

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


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


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

The uses of GF-2626 on fruiting vegetables and ornamentals grown under protection will not lead to significant exposure of non-target plants, thus the risk to this wildlife group is considered to be negligible.

Other non-target species (Flora and Fauna)

Tests on other non-target species are not required.

3.1.7 Efficacy

Claim

This application concerns the registration of CLOSER (GF-2626) for greenhouse use in the Central Zone in The Netherlands. CLOSER is an insecticide formulated as a soluble concentrate (SC) containing 120 g/L sulfoxaflor. It is aimed to control different species of aphids and whiteflies in greenhouse grown Cucurbit crops (with edible and inedible peel), Solanaceous crops and Ornamentals. In an parallel application authorization of CLOSER (GF-2626) is sought for use in field grown potato, brassica crops and ornamental crops. For aphid control under protected conditions with CLOSER, a dose rate of 0.2 L/ha (24 g a.s./ha) is claimed and for whitefly control a dose rate of 0.4 L/ha (48 g a.s./ha) is claimed either applied in a single application or in a split application with 2 x 0.2 L/ha. The maximum dose per 12 months is restricted to 0.4 L/ha either applied in a single application of 0.4 L/ha (only for white fly) or in two successive applications of 0.2 L/ha with a minimum interval of 7 days. In protected grown Cucurbit crops and Solanaceous

Part A



Netherlands

of 77

crops the product needs to be applied in 500 to 1500 liter water per hectare and in Ornamental crops in 200 to 2000 liter water per hectare. In NL, dose rates for protected grown Cucurbit, Solanaceous and Ornamental crops are usually given crop-stage depended by a percentage dose rate (gram or ml a.s. per 100 liter spray volume) to avoid overdosing on small plants and under dosing on full grown crops. However, for CLOSER fixed dose rates are claimed in a range of spray volumes which according to zRMS conclusions are acceptable but to be confirmed by NL on national level. Overall conclusion of the zRMS is that all claimed uses are acceptable from an efficacy point of view but need to be confirmed at MS level considering: • The distribution of trials considering the type of greenhouse / glasshouse / tunnels

where trials were performed. • Extrapolations possibilities on minor uses and/or pest group. Preliminary tests

In total four preliminary laboratory studies evaluating pre-emergence herbicidal activity (2 studies) and post-emergence herbicidal activity (2 studies) showed no herbicidal effects of sulfoxaflor (at the intended dose rate) on the tested monocot and dicot species. High-throughput screens (HTS) demonstrated that sulfoxaflor did not show fungicidal activity on four fungal species representing three fungal phyla; therefore it’s unlikely that sulfoxaflor applied at intended dose rates has any fungicidal activity. Several laboratory tests and three preliminary field trials in tomato (2 trials) and eggplant (1 trial) showed that sulfoxaflor had an interesting control on sap feeding pests (aphids & whiteflies) at dose rates ranging from 6 to 50 g sulfoxaflor per hectare but showed no insecticidal activity on nematodes or insects in the orders of Coleoptera, Lepidoptera,

Diptera.

Efficacy

Since zRMS left confirmation of trial distribution regarding type of greenhouse and the use of extrapolation tables up to the individual CMS, for each use a comprehensive trial overview has been compiled in order to endorse these considerations. Aphid control in Cucurbit and Solanaceous crops

For Cucurbit crops, in the core dossier, data was presented from 12 trials all conducted on Aphis gossypii, APHIGO in Cucurbit crops Cucumber, CUMSA (7 trials), Zucchini, CUUPG (3 trials) & Melon CITLA (2 trials). All trials were conducted in the Mediterranean EPPO Climatic Zone (ES [9 trials], FR [1 trial], IT [1 trial] & PO [1 trial]) between 2008 and 2010. In these trials efficacy of the claimed dose rate 24 g a.s./ha as well as various other rates (ranging from 6 g a.s./ha up to 36 g a.s./ha which is equivalent to 25% up to 150% of the claimed dose rate) were tested and compared to a currently NL-authorized reference product delivering 50 to 100 g a.s./ha acetamiprid. In all Mediterranean Cucurbit trials a single application was carried out at various crop stages (ranging from BBCH 15 to 81) at various crop heights (ranging from 0.15 to 2.1 meters).

Part A



Netherlands

of 77

Across the trials, the application took place in spray volumes ranging from 500 to 1000 liter per hectare. In the NL-addendum, additional data was presented from one trial conducted in 2016 in NL (belonging to Maritime EPPO Climatic Zone) on APHIGO in Cucumber (CUMSA). In the NL trial a single application was carried out with 0.2 L/ha CLOSER in a spray volume of 1500 L/ha when the crop had reached BBCH 85 approx. 2.0 meters height. For Solanaceous crops, in the core dossier, data was presented from 15 trials targeting Aphis gossypii, APHIGO (9 trials), Myzus persicae, MYZUPE (5 trials) and in 1 trial both species in Solanaceous crops Bell pepper, CPSAN (8 trials), Eggplant, SOLME (5 trials) & Tomato, LYPES (2 trials). Trials were conducted in the Mediterranean EPPO Climatic Zone (ES [7 trials], GR [1 trial] & IT [6 trials] and the South-East EPPO Climatic Zone (HU [1trial]) between 2008 and 2010. In these trials efficacy of the claimed dose rate 24 g a.s./ha as well as various other rates (ranging from 6 g a.s./ha up to 36 g a.s./ha which is equivalent to 25% up to 150% of the claimed dose rate) were tested and compared to a currently NL-authorized reference product delivering 50 to 100 g a.s./ha acetamiprid. In all Solanaceous trials a single application was carried out at various crop stages (ranging from BBCH 15 to 89) at various crop heights (ranging from 0.25 to 0.65 meters in trials crop height was recorded). Across the trials, the application took place in spray volumes ranging from 500 to 1250 liter per hectare. In the NL-addendum, additional data was presented from two trials conducted in 2015 & 2016 in BE (belonging to Maritime EPPO Climatic Zone) on MYZUPE in Bell Pepper (CPSAN). In the BE trials a single application was carried out with 0.2 L/ha CLOSER in 750 to 1000 liter water per hectare (based on 750 liter water per LWA) when the crops had reached 0.8 to 1.0 meters height (BBCH 61-62). Based on the comparability of the efficacy results achieved on aphids APHIGO and MYZUPE with the claimed dose rate of 24 g a.s./ha in the Maritime trials in Cucumber and Bell Pepper (presented in the NL addendum) and the similar treatment in the Mediterranean trials (presented in the core dossier) it is accepted that justification regarding MED and efficacy of the claimed use on aphids in Cucurbit and Solanaceous crops is been built on a data set which is compiled from Mediterranean trials only. Regarding the use of extrapolations, data generated in Cucurbit crops is, according to EPPO extrapolation table PP 1/257/IEET 37 (2), considered as supportive to justify the claimed use on aphids in Solanaceous crops and, vice-versa, data from Solanaceous crops are considered supportive for the claim in Cucurbit crops according to EPPO extrapolation table PP 1/257 IEET 17 (2). Therefore, based on the (combined) generated efficacy data sets on APHIGO and MYZUPE in Cucurbit as well as Solanaceous crops of various dose rates CLOSER, zRMS conclusion that a dose range of 12-24 g a.s./ha is the appropriate one for adequate control of aphids in Cucurbit and Solanaceous crops is accepted. Across all trials the efficacy of a single application of 12 to 24 g a.s./ha CLOSER (equivalent to 0.1 to 0.2 liter product/ha) applied in spray volumes ranging from 500 to 1500 liter water per hectare achieved at least similar to superior control on aphids

Part A



Netherlands

of 77

APHIGO and MYZUPE in Cucurbit and Solanaceous crops compared to the reference product based on acetamiprid. In conclusion, the claimed efficacy of 12 to 24 g a.s./ha CLOSER against aphids in Cucurbit and Solanaceous crops grown under protected conditions is sufficiently and acceptably justified. However, as the fixed dose is not suitable for protected grown Cucurbit and Solanaceous crops in NL, the claimed dose rate of 0.2L/ha CLOSER is converted to a crop-stage depended percentage dose of 0.013% (13 ml product per 100 L water) to be applied with a maximum of 1500 L/ha spray volume (equivalent to a maximum of 24 g a.s./ha). The use will be restricted, by instructions of use, to maximum two applications (maximum of 0.4 L/ha) per 12 months to be applied with a minimum interval of 7 days. Aphid control in Ornamental crops

For Ornamental crops, in the core dossier, data was presented from 9 trials on Aphis

gossypii, APHIGO (2 trials), Myzus persicae, MYZUPE (2 trials), Macrosiphum

euphorbiae, MACSEU (3 trials), Aphis fabae, APHIFA (1 trial) and a mix of aphids, APHISP (1 trial) in important Floricultural crops such as Chrysanthemum, CHYSS (4 trials) and Daisy, BELPE (2 trials). No trials in Flower bulb & flower tuber crops were provided. All trials were conducted between 2008 and 2012 in IT belonging to the Mediterranean EPPO Climatic Zone. In these trials efficacy of the claimed dose rate 24 g a.s./ha as well as various other rates (ranging from 6 g a.s./ha up to 36 g a.s./ha which is equivalent to 25% up to 150% of the claimed dose rate) were tested and compared to a currently NL-authorized reference product delivering 50 to 100 g a.s./ha acetamiprid. In all Ornamental trials a single application was carried out at various crop stages (ranging from BBCH 55 to 65) at various crop heights (ranging from 20 centimetres for potted plants to 80 centimetres for chrysanthemum). Across the trials, the application took place in spray volumes ranging from 800 to 1400 liter per hectare. In the NL-addendum, additional data was presented from two greenhouse trials conducted in 2015 in BE (belonging to Maritime EPPO Climatic Zone) on MYZUPE in Hibiscus, HIBRS and in Pansy, VIOWH. In these trials a single application was carried out with 0.2L/ha CLOSER in a spray volume of 1000 liter water per hectare when the crop was in BBCH 59-61. Furthermore, supporting data from two field trials conducted in 2016 in NL and BE on MYZUPE in Chrysanthemum, CHYSS and Pansy, VIOWH were presented in the NL addendum. Based on the comparability of the efficacy results achieved on MYZUPE with the claimed dose rate of 24 g a.s./ha in the Maritime trials in Ornamental crops (presented in the NL addendum) and similar treatments in the Mediterranean trials (presented in the core dossier) it is accepted that justification regarding MED and efficacy of the claimed uses on aphids in Ornamental crops is been built on a data set which is compiled from Mediterranean trials only. Furthermore, according to EPPO extrapolation tables PP 1/257/IEET 37 (2) and PP 1/257 IEET 17 (2), data generated in Cucurbit and Solanaceous crops can be extrapolated to Ornamental crops. Therefore, the generated data in these crops are considered as

Part A



Netherlands

of 77

supportive to justify the claimed use on aphids in the Floricultural crops (cut flowers & potted plants) as growing conditions in NL greenhouses for Cucurbit, Solanaceous and Floricultural crops are very similar to each other. In the contrary to the accepted extrapolation of data to Floricultural crops, extrapolation of the same data to justify the claim in Flower bulb & Flower tuber crops is considered inappropriate as growing conditions in NL greenhouses do substantially differ between the Flower bulb & Flower tuber crops and Cucurbit and Solanaceous crops. Therefore, based on the generated efficacy data set of various dose rates CLOSER on especially APHIGO, MYZUPE & MACSEU in Floricultural crops and taken into account the supportive results achieved on APHIGO & MYZUPE in Cucurbit & Solanaceous crops, the zRMS conclusion that a dose range of 12-24 g a.s./ha is the appropriate one for adequate control of aphids in Floricultural crops is accepted. Across all trials in the Floricultural crops the efficacy of a single application of 12 to 24 g a.s./ha CLOSER (equivalent to 0.1 to 0.2 liter product/ha) applied in spray volumes ranging from 800 to 1400 liter water per hectare achieved at least similar to superior control on aphids APHIGO, MYZUPE & MACSEU than the reference product based on acetamiprid which is once again supported by the generated data from Cucurbit and Solanaceous trials. In conclusion, the claimed efficacy of 24-48 g a.s./ha CLOSER against aphids in in Floricultural crops (cut flowers & potted plants) grown under protected conditions is sufficiently and acceptably justified in specific trials and taking into account the supportive data from Cucurbit and Solanaceous crops. However, as the fixed dose is not suitable for protected grown Floricultural crops in NL, the claimed dose rate of 0.2L/ha CLOSER is converted to a crop-stage depended percentage dose of 0.013% (13 ml product per 100 L water) to be applied with a maximum of 1500 L/ha spray volume (equivalent to a maximum of 24 g a.s./ha). The use will be restricted, by instructions of use, to maximum two applications (maximum of 0.4 L/ha) per 12 months to be applied with a minimum interval of 7 days. Justification of the claimed use on Flower bulb & Flower tuber crops is not accepted as no trials on these crops were provided and data extrapolation from the other trials is considered inappropriate due to substantial differences in cultivation conditions. Whitefly control in Cucurbit and Solanaceous crops

For Cucurbit crops, in the core dossier, data was presented from 13 trials targeting Trialeurodes vaporariorum, TRIAVA (6 trials) and Bemisia tabaci (7 trials) in Cucurbit crops Cucumber, CUMSA (9 trials) and Zucchini, CUUPG (4 trials). Most trials were conducted in the Mediterranean EPPO Climatic Zone (ES [8 trials], GR [1 trial] & IT [3 trial]) between 2007 and 2013. In these trials efficacy of the claimed dose rate 48 g a.s./ha applied in a single application as well as various other rates (from 24-25 g a.s./ha up to 72-75 g a.s./ha which is equivalent to 50% up to 156% of the claimed dose rate) were tested and compared to a currently NL-authorized reference product delivering 70 to 75 g a.s./ha acetamiprid. In six out of 12 trials efficacy of a single application at the full rate (48 g a.s./ha) was compared to efficacy of a split application (2 times 24 g a.s./ha applied with 7-days interval). In all Mediterranean Cucurbit trials applications were carried out at various crop stages (ranging from BBCH 12 to 85) at various crop heights (ranging from

Part A



Netherlands

of 77

0.10 to 1.9 meters). Across the trials, applications took place in spray volumes ranging from 500 to 1000 liter per hectare. In addition, data from one trial conducted in Maritime EPPO Climatic Zone (UK) was submitted in the core dossier. However, since applications in this trial took place at young plants (BBCH 13-14) with only 400 L/ha spray volume, it is considered that these conditions do not reflect normal growing conditions of Cucurbit crops in the Maritime EPPO Climatic Zone and therefore data were considered only as supportive. In the NL-addendum, additional data was presented from one trial conducted in 2016 in NL (belonging to Maritime EPPO Climatic Zone) on TRIAVA in Cucumber (CUMSA). In the NL trial a split application of 2 times 24 g a.s./ha was carried out with an interval of 13 days in a spray volume of 1500 liter per hectare when the crop had reached approx.2.0 meters height (BBCH 85). For Solanaceous crops, in the core dossier, data was presented from 22 trials Trialeurodes

vaporariorum, TRIAVA (9 trials) and Bemisia tabaci (13 trials) in Solanaceous crops Tomato, LYPES (13 trials), Eggplant, SOLME (5 trials) & Bell pepper, CPSAN (4 trials). In these trials efficacy of the claimed dose rate 48 g a.s./ha applied in a single application as well as various other rates (from 24-25 g a.s./ha up to 72-75 g a.s./ha which is equivalent to 50% up to 156% of the claimed dose rate) were tested and compared to a currently NL-authorized reference product delivering 70 to 75 g a.s./ha acetamiprid. In ten out of 12 trials efficacy of a single application at the full rate (48 g a.s./ha) was compared to efficacy of a split application (2 times 24 g a.s./ha applied with 7-days interval). In all Solanaceous trials applications were carried out at various crop stages (ranging from BBCH 14 to 87) at various crop heights (ranging from 0.20 to 2.0 meters). Across trials, applications took place in spray volumes ranging from 500 to 1500 L/ha. In the NL-addendum, additional data was presented from one trial conducted in 2016 in NL (belonging to Maritime EPPO Climatic Zone) on TRIAVA in Tomato (LYPES). In the NL trial a split application of 2 times 24 g.a./ha was carried out with an interval of 14 days in a spray volume of 1000 liter per hectare when the crop had reached BBCH 72-73 and a height of 1.75 meters (1st application) to 2.5 meters (2nd application). Based on the comparability of the efficacy results achieved on whitefly TRIAVA with the claimed split application of 2 times 24 g a.i./ha in the Maritime trials in Cucumber and Tomato (presented in the NL addendum) and the similar treatment in the Mediterranean trials (presented in the core dossier) it is accepted that justification regarding MED and efficacy of the claimed use on whitefly TRIAVA in Cucurbit and Solanaceous crops is been built on a data set which is compiled from Mediterranean trials only. Regarding the use of extrapolations, data generated on TRIAVA & BEMITA in Cucurbit and Solanaceous crops is, according to EPPO extrapolation table PP 1/257/IEET 72 (1), considered to be supportive to justify the claimed use on whiteflies in both crop groups. Combined with the demonstrated comparability in both Climatic Zones it is therefore accepted that trial results on BEMITA in Mediterranean Climatic Zone are extrapolated to justify the efficacy of CLOSER on BEMITA in Maritime Climatic Zone.

Part A



Netherlands

of 77

Therefore, based on the (combined) generated efficacy data on TRIAVA and BEMITA in Cucurbit as well as Solanaceous crops of various dose rates CLOSER, zRMS conclusion that a dose of 48 g a.s./ha is the appropriate one for adequate control of whiteflies TRIAVA and BEMITA in Cucurbit and Solanaceous crops is accepted. Across all trials the efficacy of a single application of 48 g a.s./ha CLOSER (equivalent to 0.4 liter product/ha) applied in spray volumes ranging from 500 to 1500 liter water per hectare achieved at least similar to superior control on whiteflies TRIAVA and BEMITA in Cucurbit and Solanaceous crops than the reference product based on acetamiprid. In addition, the split applications of 2 times 24 g a.s./ha (0.2 liter product/ha) applied in a 7 to 14 days interval showed that, although the initial efficacy was inferior, that finally similar efficacy was achieved as by a single application at full rate of 48 g a.s./ha. In conclusion, the claimed efficacy of a single application of 48 g a.s./ha as well as the split application of 2 times 24 g a.s/ha CLOSER against whitefly in Cucurbit and Solanaceous crops grown under protected conditions is sufficiently and acceptably justified. However, as the fixed dose is not suitable for protected grown Cucurbit and Solanaceous crops in NL, the claimed dose rate of a single application of 0.4L/ha CLOSER is converted to a crop-stage depended percentage dose of 0.026% (26 ml product per 100 L water) to be applied with a maximum of 1500 L/ha spray volume (equivalent to a maximum of 48 g a.s./ha). The percentage dose rate of the split application is set to 0.013 (13 ml product per 100 L) to be applied with a minimum interval of 7 days and also in maximum 1500 L/ha spray volume. The use will be restricted, by instructions of use, to a maximum of 0.4 L/ha (48 g a.s/ha) per 12 months (either applied in one application at full rate or in split application of 2 times the half rate).

Whitefly control in Ornamental crops

For Ornamental crops, in the core dossier, data was presented from 3 trials on Trialeurodes vaporariorum, TRIAVA in Floricultural crops Poinsettia (EPHPU), Gerbera (GEBJA) and Lantana (LANCA). No trials in Flower bulb & flower tuber crops were provided. These trials were conducted between 2008 and 2012 in IT belonging to the Mediterranean EPPO Climatic Zone. In these trials efficacy of the claimed dose rate 48 g a.s./ha applied in a single application as well other rates 12 g a.s./ha and 24-25 g a.s./ha (which are equivalent to 25% to 50% of the claimed dose rate) were tested and compared to currently NL-authorized reference products delivering 75 g a.s./ha acetamiprid or 125 to 150 g a.s./ha thiamethoxam. In one out of three trials efficacy of a single application at the full rate (48 g a.s./ha) was compared to efficacy of a split application (2 times 24 g a.s./ha applied with 7-days interval). In all Mediterranean Ornamental trials applications were carried out at various crop stages (ranging from BBCH 19 to 65) at a crop height of 0.3 meters (potted plants). Across the trials, applications took place in spray volumes ranging from 800 to 1500 liter per hectare. In addition two supportive field trials, conducted in 2013 in IT on TRIAVA in Ornamental crops Poinsettia (EPHPU), and Lantana (LANCA), were submitted. In these trials efficacy of a single application at the full rate (48 g a.s./ha) was compared to efficacy of a split application (2 times 24 g a.s./ha applied with 7-days interval) and to

Part A



Netherlands

of 77

currently NL-authorized reference product delivering 75 g a.s./ha acetamiprid. Applications were carried out at crop stages ranging from BBCH 33 to 64) at a crop height of 0.2 to 0.3 meters (potted plants), in a spray volume of 1100 liter per hectare. In the NL-addendum, additional data was presented from a greenhouse trials conducted in 2015 in BE (belonging to Maritime EPPO Climatic Zone) on TRIAVA in Fuchsia (FUCSS). In this trial a single application was carried out with 0.2 L/ha CLOSER in a spray volume of 1000 liter water per hectare when the crop was in BBCH 38 and reached a height of 0.35 meter. Furthermore, supporting data from two field trials conducted in 2016 in NL and BE on TRIAVA in Rosa (ROSSS) and Sage (SALSS) were presented in the NL addendum, however since due to low infestation these trials were considered not valid to support the claimed use. Based on the comparability of the efficacy results achieved on TRIAVA with the claimed dose rate of 48 g a.s./ha in the Maritime trial in FUCSS (presented in the NL addendum) and the similar treatment in the Mediterranean trials (presented in the core dossier) it is accepted that justification regarding MED and efficacy of the claimed use on whitefly TRIAVA in Ornamental crops is been built on a data set which is compiled from (a limited number of) Mediterranean trials only. Furthermore, according to EPPO extrapolation table PP 1/257/IEET 72 (1), data generated on TRIAVA and BEMITA in Cucurbit and Solanaceous crops can be extrapolated to Ornamental crops. The generated data in these crops are therefore considered as supportive to justify the claimed use on whitefly TRIAVA in Floricultural crops as growing conditions in NL greenhouses for Cucurbit, Solanaceous and Floricultural crops are very similar to each other. In addition, it is accepted that the generated data on BEMITA in Cucurbit and Solanaceous crops in the Mediterranean Zone are extrapolated to justify the efficacy of CLOSER on BEMITA in Floricultural crops in Maritime EPPO Climatic Zone as climate conditions in NL greenhouses are considered similar to the conditions in which the trials were performed.

Therefore, based on the generated efficacy data of various rates CLOSER on TRIAVA in Floricultural crops and taking into account the results achieved in Cucurbit & Solanaceous crops, zRMS conclusion that 48 g a.s./ha is the appropriate one for adequate control of whiteflies TRIAVA & BEMITA in Ornamental crops is accepted.

Across the (limited number of) ornamental trials the efficacy of a single application of 48 g a.s./ha CLOSER (equivalent to 0.2 liter product/ha) applied in spray volumes ranging from 800 to 1500 liter water per hectare achieved at least similar to superior control on whitefly TRIAVA in Ornamental crops than the reference product based on acetamiprid. In addition, the split applications of 2 times 24 g a.s./ha applied in a 7 to 14 days interval showed, although the initial efficacy was inferior, that finally similar efficacy was achieved as by a single application at full rate of 48 g a.s./ha.

In conclusion, the claimed efficacy of a single application of 48 g a.s./ha or a split application of 2 times 24 g a.s./ha CLOSER against whiteflies TRIAVA & BEMITA in Floricultural crops (cut flowers & potted plants) grown under protected conditions is, although a limited number of trials, considered sufficiently and acceptably justified,

Part A



Netherlands

of 77

especially when taking the generated supportive data on TRIAVA and BEMITA from Cucurbit and Solanaceous crops into account. In conclusion, the claimed efficacy of a single application of 48 g a.s./ha as well as the split application of 2 times 24 g a.s/ha CLOSER against whitefly in Cucurbit and Solanaceous crops grown under protected conditions is sufficiently and acceptably justified. However, as the fixed dose is not suitable for protected grown Floricultural crops in NL, the claimed dose rate of a single application of 0.4L/ha CLOSER is converted to a crop-stage depended percentage dose of 0.026% (26 ml product per 100 L water) to be applied with a maximum of 1500 L/ha spray volume (equivalent to a maximum of 48 g a.s./ha). The percentage dose rate of the split application is set to 0.013 (13 ml product per 100 L) to be applied with a minimum interval of 7 days and also in maximum 1500 L/ha spray volume. The use will be restricted, by instructions of use, to a maximum of 0.4 L/ha (48 g a.s/ha) per 12 months (either applied in one application at full rate or in a split application of 2 times the half rate (24 g a.s/ha). Justification of the claimed use on Flower bulb & Flower tuber crops is not accepted as no trials on these crops were provided and data extrapolation from the other trials is considered inappropriate due to substantial differences in cultivation conditions.

Yield and quality

No additional data (yield trials in non-infested crop) was generated because no phytotoxicity was observed in any trial. It is concluded that commercial use of sulfoxaflor, when applied as recommended, will not have any deleterious effect on the yield of treated plants and plant products. Adverse effects

Phytotoxicity to host crops

Data was presented of 22 trials in which several Cucurbit crops and varieties were tested at various rates (up to 75 g a.s./ha) applied once or, in some of the trials, twice. No instances of phytotoxicity were recorded in these trials indicating that the product CLOSER is safe to Cucurbit crops. Data was presented of 37 trials in which several Solanaceous crops and varieties were tested at various rates (up to 75 g a.s./ha) applied once or in some trials twice. No instances of phytotoxicity were recorded in these trials indicating that the product CLOSER is safe to Solanaceous crops. However, since no crop safety data were presented from Maritime trials conducted under low-light conditions (which are considered worse-case by NL) a warning sentence regarding crop safety under low-light conditions will be placed on the Dutch label for protected grown Cucurbit and Solanaceous crops. Data was presented of 13 Ornamental trials in which 35 different ornamental species were tested. In one non-GEP demonstration trial, conducted in BE (Maritime Zone), 27 ornamental species were tested under low light and in challenging conditions and included a 3N dose rate of 144 g a.s./ha. The other 12 trials were conducted in IT (Mediterranean Zone) in which only the claimed rate of 48 g a.s./ha was tested and not the 2N dose rate. No instances of phytotoxicity were recorded in the BE trial but as it was only one trial this could not be further verified. Also in none of the IT trials instances of

Part A



Netherlands

of 77

phytotoxicity were observed indicating that the product CLOSER is safe to Ornamental crops. However, considering the importance of the visual aspects for ornamental plants, and the high diversity of crops and cultivars it is not possible to exclude any adverse effects on ornamental crops, especially given that the tested circumstances of the trials (non-GEP trial, Mediterranean Zone and no trials under low-light circumstances) were not worst-case. Therefore warning sentences regarding crop safety under low light conditions and the use of CLOSER in Floricultural crops will be placed on the Dutch label. According to aforementioned reasons the following warning sentences regarding crop safety to Cucurbit, Solanaceous and Ornamental crops will be place on the Dutch label: Impact on Succeeding and Adjacent Crops

No negative effects on succeeding and adjacent crops are expected following the Adverse effects on beneficial organisms (other than bees) For, the assessment of the impact on beneficial and other non-target organisms, reference is made to the eco-toxicological part of the dossier (section 6). However, from an efficacy point of view, it is considered that CLOSER, being an insecticide as it is, can effect beneficial populations introduced in the framework of an IPM strategy.

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. Resistentiemanagement

Dit middel bevat de werkzame stof sulfoxaflor welke behoort tot de sulfoximines. 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.

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.

Part A



Netherlands

of 77

3.2 On the Dutch label the following resistance management sentence will be

placed: 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 therefore be granted.

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.

Part A



Netherlands

of 77

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 12 maanden

Minimum interval tussen toepassingen in dagen

Veiligheids-termijn in dagen

Vruchtgroenten van Cucurbitaceae met eetbare schil (bedekte teelt)

Bladluis2,3 0.013% (13 ml per 100 L)

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

7

1

Witte vlieg4,5 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)

Bladluis2,3 0.013% (13 ml per 100 L)

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

7

1


0,2 L/ha 2

0.026% (26 ml per 100 L)

0,4 L/ha 1

Vruchtgroenten van Bladluis2,3 0.013% 0,2 L/ha 2 0,4L/ha 7 1

Part A



Netherlands

of 77

Toepassingsgebied Werkzaamheid getoetst op

Dosering* (middel) per toepassing

Maximale dosering per toepassing

Maximaal aantal toepassingen per 12 maanden

Maximaal aantal liter middel per ha 12 maanden

Minimum interval tussen toepassingen in dagen

Veiligheids-termijn in dagen

Solanaceae (bedekte teelt)

(13 ml per 100 L)


0,2 L/ha 2

0.026% (26 ml per 100 L)

0,4 L/ha 1

Bloemisterijgewassen (bedekte teelt)

Bladluis1,2,3 0.013% (13 ml per 100 L)

0,2 L/ha 2 0,4L/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 Groene perzikluis (Myzus persicae) 3 Katoenluis (Aphis gossypii)

4Tabakswittevlieg (Bemisia tabaci) 5Witte vlieg (Trialeurodes vaporariorum)

Overige toepassingsvoorwaarden

Part A



Netherlands

of 77

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 leveranciers van bestuivers en van 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”.

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 welke behoort tot de sulfoximines. 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.

Part A



Netherlands

of 77

Appendix 2 Letter of Access

Not applicable.

Part A



Netherlands

of 77

Appendix 3 Reference list

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

Part A



Netherlands

of 77

Annex

Point/

Reference

Number

Year Title


from 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 2.7.4 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

KIIIAI 2.7.2/01

2011 GF-2626: Laboratory Study of Accelerated Storage Stability at 40 ˚C in PET and HDPE Containers Source: International Institute of Biotechnology and Toxicology, Tamil Nadu, India Report No.: NAFST-11-65 GLP/GEP (Y/N): Y

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

Part A



Netherlands

of 77

Annex

Point/

Reference

Number

Year Title


from the Company),



relevant),

Published or not

Data

protection

claimed

(Y/N)

Study

relied on

(Y/N)

Data

protection

granted

Y/N

Owner

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

Author Year Title

Source (where different from

company)

Company

Report No.

GLP or GEP status

Published or unpublished

Data

protection

claimed

(Y/N)

Data

protection

granted

Y/N

Owner

KIIIA1 5.2.1

Waid, C. 2010 Analytical Method and Validation for the Determination of Sulfoxaflor in GF-2650 and GF-2626 End Use Products

Report No.: DAS-AM-G-11-01 GLP/GEP (Y/N): Y Published (Y/N): N

Y Y DAS

KIIIA1 5.3.1/01

Rodrigues Junior, A.

2010b Residue Method Validation for the Determination of XDE-208 and its Major Metabolites (X11719474 and X11721061) in Agricultural Commodities and Processed Products using On-Line Solid-Phase Extraction and Liquid Chromatography with Tandem Mass Spectrometry Detection

Dow AgroSciences Ind. Ltda., Mogi Mirim, SP 13800-970, Brazil

Report No.: 091031

GLP/GEP (Y/N): Y

Y Y DAS

Part A



Netherlands

of 77

Annex

Point

Author Year Title


company)

Company

Report No.

GLP or GEP status


Data

protection

claimed

(Y/N)

Data

protection

granted

Y/N

Owner

Published (Y/N): N

KIIIA 5.3.1/02

Seal, S 2010a Independent Laboratory Validation of Enforcement Method for the Determination of Sulfoxaflor (XDE-208) and its Main Metabolites in Agricultural Commodities using Offline Solid-Phase Extraction and Liquid Chromatography with Tandem Mass Spectrometry Detection

Pyxant Labs Inc., Colorado Springs, CO 80907, USA

Report No.: 101097

GLP/GEP (Y/N): Y

Published (Y/N): N

Y Y DAS

KIIIA 5.3.1/03

Rawle, N. 2009 Laboratory Validation of a Method for the Determination of XDE-208, X11719474 and X11721061 in Dry Crops, Acid Crops, Oily Crops and Crops with a High Water Content

CEM Analytical Services Limited, North Ascot, Berkshire, UK

Report No.: CEMS-4295

GLP/GEP (Y/N): Y

Published (Y/N): N

Y Y DAS

KIIIA 5.3.1/04

Wendelburg, B.M.

2011 Method Validation Study for the Determination of Residues of XDE-208 and its Major Metabolites in Bovine and Poultry Tissues using Offline Solid-Phase Extraction and Liquid Chromatography with Tandem Mass Spectrometry Detection (Amended Report)

Dow AgroSciences LLC, Indianapolis, IN 46268, USA

Y Y DAS

Part A



Netherlands

of 77

Annex

Point

Author Year Title


company)

Company

Report No.

GLP or GEP status


Data

protection

claimed

(Y/N)

Data

protection

granted

Y/N

Owner

Report No.: 091188 (Amended)

GLP/GEP (Y/N): Y

Published (Y/N): N

KIIIA 5.3.1/05

Seal, S. 2010b Independent Laboratory Validation Study for the Determination of Residues of Sulfoxaflor (XDE-208) and its Major Metabolites in Bovine and Poultry Tissues Using Offline solid-Phase Extraction and Liquid Chromatography with tandem Mass Spectrometric Detection

Pyxant Labs Inc., Colorado Springs, CO 80907, USA

Report No.: 101098

GLP/GEP (Y/N): Y

Published (Y/N): N

Y Y DAS

KIIIA 5.3.1/06

Rawle, N. 2010a Laboratory Validation of a Method for the Determination of XDE-208, X11719474 and X11721061 in Bovine Milk, Skim Milk, Cream, Muscle, Liver, Kidney and Fat

CEM Analytical Services Limited, North Ascot, Berkshire, UK


GLP/GEP (Y/N): Y

Published (Y/N): N

Y Y DAS

KIIIA 5.3.1/07

Rawle, N 2010b Laboratory Validation of a Method for the Determination of XDE-208, X11719474 and X11721061 in Hen Eggs, Muscle, Liver and Fat

CEM Analytical Services Limited, North Ascot,

Y Y DAS

Part A



Netherlands

of 77

Annex

Point

Author Year Title


company)

Company

Report No.

GLP or GEP status


Data

protection

claimed

(Y/N)

Data

protection

granted

Y/N

Owner

Berkshire, UK


GLP/GEP (Y/N): Y

Published (Y/N): N

IIIA 5.4/01

Wendelburg, B.M., Olberding, E.L.

2011a Method Validation Study for the Determination of Residues of XDE-208 and its Major Metabolites in Soil using Offline Solid-Phase Extraction and Liquid Chromatography with Tandem Mass Spectrometry Detection (Amended Report)


Report No.: 091185

GLP/GEP (Y/N): Y

Published (Y/N): N

Y Y DAS

IIIA 5.4/02

Gravelle, W. 2010 Independent Laboratory Validation of the Analytical Methodology Used for the Determination of XDE-208 (X11422208) and its Metabolites (X11519540, X11579457, and X11719474) in Sandy Loam and Clay Loam Soils

Eurofins Product Safety Labs (PSL), Dayton, NJ 08810, USA

Report No.: 101100

GLP/GEP (Y/N): Y

Published (Y/N): N

Y Y DAS

KIIIA 5.6/01

Wendelburg, B.M., Olberding, E.L.

2011b Method Validation Study for the Determination of Residues of XDE-208 and its Major Metabolites in Water using Offline Solid-Phase Extraction and Liquid Chromatography with Tandem Mass Spectrometry Detection

Y Y DAS

Part A



Netherlands

of 77

Annex

Point

Author Year Title


company)

Company

Report No.

GLP or GEP status


Data

protection

claimed

(Y/N)

Data

protection

granted

Y/N

Owner

(Amended Report)


Report No.: 091186 (Amended)

GLP/GEP (Y/N): Y

Published (Y/N): N

KIIIA 5.7/01

Merdian, H. 2010b The Development and Validation of a Method for the Analysis of XDE-208 in Air

PTRL Europe GmbH, Science Park, D-89081, Ulm, Germany

Report No.: 091133

GLP/GEP (Y/N): Y

Published (Y/N): N

Y Y DAS

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)

Owner Studies

relied

on Y/N

Data

protection

granted

Y/N

KIIIA 7.1.1

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

Y DAS Y Y

Report No.:

080049

GLP/GEP (Y/N):

Y

Published (Y/N):

N

Part A



Netherlands

of 77

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)

Owner Studies

relied

on Y/N

Data

protection

granted

Y/N

KIIIA 7.1.2

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

Y DAS Y Y

Report No.:

080050

GLP/GEP (Y/N):

Y

Published (Y/N):

N

KIIIA 7.1.3

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

Y DAS Y Y

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 DAS Y Y

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 DAS Y Y

Report No.:

080052

Part A



Netherlands

of 77

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)

Owner Studies

relied

on Y/N

Data

protection

granted

Y/N

GLP/GEP (Y/N):

Y

Published (Y/N):

N

KIIIA 7.1.6

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

Y DAS Y Y

Report No.:

081180

GLP/GEP (Y/N):

Y

Published (Y/N):

N

Report No.:

101091

GLP/GEP (Y/N):

Y

Published (Y/N):

N

Part A



Netherlands

of 77

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)

Owner Studies

relied

on Y/N

Data

protection

granted

Y/N

KIIIA 7.6/01

2010 XDE-208: The In Vivo Percutaneous Absorption of Radiolabelled XDE-208 in Formulation (GF-2032) and Two In-Use Spray Dilutions in the Rat (OECD 427)

Charles River, UK

Report No.: 191168

GLP/GEP (Y/N): Y

Published (Y/N): N

Y DAS Y Y

KIIIA 7.6.2/01

2010 XDE-208: The In Vitro Percutaneous Absorption of Radiolabelled XDE-208 in Formulation (GF-2032) and Two In-Use Spray Dilutions through Rat and Human Skin (OECD 428) Charles River, UK Report No.: 786740 GLP/GEP (Y/N): Y Published (Y/N): N

Y DAS Y Y

Part A



Netherlands

of 77

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)

Owner Studies

relied

on Y/N

Data

protection

granted

Y/N

IIIA 7.7.1/02

2010b Dissipation of Dislodgeable Foliar Sulfoxaflor Residues from Treated Broccoli

Dow AgroSciences Laboratory, USA

Report No.: 101091

GLP/GEP (Y/N): Y

Published (Y/N): N

Y DAS Y Y

Annex

point Year

Title


company)

Company, Report No.


relevant)

Published or Unpublished

Data

protection

claimed

Y/N

Data

protection

granted

Y/N

Owner

Relied

on

Y/N

IIIA 8.3.1.1/01

2011a

Residues of XDE-208 in indoor tomatoes at intervals and harvest

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

Dow AgroSciences

DAS report CEMR-4698

Y

Unpublished

Y Y DAS Y

IIIA 8.3.1.1/02

IIIA 8.3.5.1/06

2012a

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 DAS Y

Part A



Netherlands

of 77

Annex

point Year

Title


company)

Company, Report No.


relevant)


Data

protection

claimed

Y/N

Data

protection

granted

Y/N

Owner

Relied

on

Y/N

IIIA 8.3.1.2/01

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 DAS Y

IIIA 8.3.1.2/02

IIIA

8.3.5.2/04

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 DAS Y

IIIA 8.3.2.1/01

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 DAS Y

IIIA 8.3.2.1/02

IIIA 8.3.6.1/04

2012b

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 DAS Y

Part A



Netherlands

of 77

Annex

point Year

Title


company)

Company, Report No.


relevant)


Data

protection

claimed

Y/N

Data

protection

granted

Y/N

Owner

Relied

on

Y/N

IIIA 8.3.2.2/01

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 DAS Y

IIIA 8.3.2.2/02

IIIA 8.3.6.2/04

2012c

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 DAS Y

IIIA 8.6.2/01

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

GLP/GEP (Y/N): Y

Published (Y/N): N

Y Y DAS Y

Annex point Year Title


company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

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

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1 1998

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

Plant Disease 82. pp:979-982

Y Y Y Dow Agro

Sciences

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

Crop Protection 8 pp:25-29.

Y Y Y Dow Agro

Sciences

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.

Y Y Y Dow Agro

Sciences

IIIA 6.1.1.2 1955 Tests with acaricides against the brown wheat mite.

. Econ. Entomol. 48 , pp. 157–161 Y Y Y

Dow Agro

Sciences

IIIA 6.1.1 IIIA 6.1.1.2 IIIA 6.2.8.7

1925 A method of computing the effectiveness of an insecticide.

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

Dow Agro

Sciences

IIIA 6.1.1 IIIA 6.2.8.6

2007

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

Dow Agro Sciences 259319

GLP/GEP: N

Published: N

Y Y Y Dow Agro

Sciences

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

Y Y Y Dow Agro

Sciences

IIIA 6.2.8.5 2013 Mini Review,Sulfoxaflor and the sulfoximine insecticides: Chemistry, mode of action and basis for efficacy on resistant insects

Pesticide Biochemistry and Physiology 107 (2013) 1-7

Y Y Y Dow Agro

Sciences

IIIA 6.1.1 2013 Fungicidal Asessement of X11422208 (sulfoxaflor)

Dow AgroSciences Y Y Y

Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.2.8 2011 Mutation of a nicotinic acetylcholine receptor b subunit is associated with resistance to neonicotinoid insecticides in the aphid Myzus persicae

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

Y Y Y Dow Agro

Sciences

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.

Y Y Y Dow Agro

Sciences

IIIA 6.2.8.6 2013 Cross-resistance relationships of the sulfoximine insecticide sulfoxaflor with neonicotinoids and other insecticides in the whiteflies 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

Y Y Y Dow Agro

Sciences

IIIA 6.2.8.6 2014

Cross-resistance relationships of the sulfoximines insecticide sulfoxaflor with pyrethroids, organophosphate, carbamate and neonicotinoid insecticides in the peach-potato aphid Myzus persicae

Dow Agro Sciences

GLP/GEP: N

Published: Y

Y Y Y

Dow Agro Sciences

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

Y Y Y Dow Agro

Sciences

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

Insecticide Resistance Action Group ,UK.

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.2.8 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

Y Y Y Dow Agro

Sciences

IIIA 6.2.8.7 2014

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

Dow Agro Sciences

GLP/GEP: N

Published: Y

Y Y Y Dow Agro

Sciences

IIIA 6.1.1 2011

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


GLP/GEP: N

Published: Y

Y Y Y Dow Agro

Sciences

IIIA 6.1.1 1997 Pymetrozine, a fast-acting and selective inhibitor of aphid feeding. In-situ studies with electronic monitoring of feeding behaviour

Pesticide Science 49(2), 130-140

Y Y Y Dow Agro

Sciences

IIIA 6.1.1 2011

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

Dow Agro Sciences

GLP/GEP: N

Published: Y

Y Y Y Dow Agro

Sciences

IIIA 6.5.1 2014

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

Dow Agro Sciences

GLP/GEP: N

Published: Y

Y Y Y Dow Agro

Sciences

IIIA 6.1.1.2 2008

XR-208 EFFICACY against aphids in winter barley

Dow Agro Sciences HU07X03017PH01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

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

Bowen, Queensland, 2010


GLP/GEP: N

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.4.2 2011 EPPO standards PP 1/243(1): Effects of plant protection products on transformation processes),

European and Mediterranean Plant Protection Organization

Y Y Y Dow Agro

Sciences

IIIA 6.1.4.2 2000 méthode d'expérimentation pour l'étude des effets non intentionnels des préparations phytopharmaceutiques sur l'élaboration et la qualité du malt et de la biere, 2000, méthode n° 185, 1ÈRE Édition 1996, RÉVISION

French CEB method 185 (quality malt and beer)

Y Y Y Dow Agro

Sciences

IIIA 6.1.4.2 2004 Méthode d' expérimentation pour l’ étude des effets non intentionnels des préparations phytopharmaceutiques sur la qualité du blé tendre et des produits de transformation

French CEB method 218 (quality of soft wheat)

Y Y Y Dow Agro

Sciences

IIIA 6.1.1 2007 Flonicamid, a novel insecticide with a rapid inhibitory effect on aphid feeding.

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

Y Y Y Dow Agro

Sciences

IIIA 6 IIIA 6.2.8.5

2011 Novel nicotinic action of the sulfoximine insecticide sulfoxaflor.

Ins Biochem Mol Biol in press Y Y Y

Dow Agro

Sciences

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

Y Y Y Dow Agro

Sciences

IIIA 6.1.1 IIIA 6.2.7

2008

Crop safety of XDE-208


GLP/GEP: N

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.2.7 2011

Effects of GF-2626 (sulfoxaflor, 120 g as/L, SC) on the Seedling Emergence of Non Target Terrestrial Plants

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

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.2.7 2011

Effects of GF-2622 (sulfoxaflor, 120 g as/L, SC) on the Vegetative Vigour of Non Target Terrestrial Plants

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

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.2.8.6 2011 Biological characterization of sulfoxaflor, a novel insecticide.

Pest Manag Sc. 67: 328–334 Y Y Y

Dow Agro

Sciences

IIIA 6.2.8.5 2002

A single P450 allele associated with insecticide resistance in Drosophila

Science 2002, 297, 2253-2256

GLP/GEP: N

Published: Y

N Y Y

IIIA 6.2.8.5 2002

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

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

GLP/GEP: N

Published: Y

N Y Y

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)


GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

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)


GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

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 Agro Sciences

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.2.8.6 2010 Bioassays and management of cotton aphids with neonicotinoids and sulfoxaflor.

Proc Beltwide Cotton Conf 2010, pp 1207-1210

Y Y Y Dow Agro

Sciences

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

Y Y Y Dow Agro

Sciences

IIIA 6.2.8.6

IIIA 6.2.8.9 2006

Whitefly/Aphid Cross Resistance Study Using Dow Agro Sciences Experimental Insecticides

Rothamsted Research, United Kingdom Stage three report

Dow Agro Science 2008457

GLP/GEP: N

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.2.8.6

IIIA 6.2.8.9 2010

Activity of XDE208 against multi-resistant Hemipteran pests

Rothamsted Research, United Kingdom

Dow Agro Science 2008458

GLP/GEP: N

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.3.1

IIIA 6.2.1 2008

Efficacy of XDE-208 on aphids in melon and cucumber crops. Europe, 2008

Dow Agro Sciences, France

FR08C1C065CR01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.3.1 IIIA 6.2.1

2008

What is the efficacy and selectivity of XDE-208 (GF-2032) on aphids in cucurbits grown outdoors in Portugal

Dow Agro Sciences, Spain

PT08C1C004MT01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 IIIA 6.1.3.1 IIIA 6.2.1

2008

What is the efficacy and selectivity of XDE-208 (GF-2032) on aphids in cucurbits grown outdoors in Spain


ES08C1C004MT02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.3.1

2010

What is the efficacy of sulfoxaflor (GF-2626) against aphids in cucurbits


ES10C1C014JM03

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 2010

Efficacy and selectivity of sulfoxaflor for the control of aphids in cucurbit crops

Dow Agro Sciences, Italy

IT10C1C014AF01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 2010



IT10C1C014AF02

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Fout! V

erwijzingsbron

niet gevonden. 2010



IT10C1C014ET01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.1 2010



IT10C1C014ET02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 2010



IT10C1C014ET03C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 2010



IT10C1C014LA01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 2010



IT10C1C014LA02

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2010



ES10C1C014SC01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 2010



ES10C1C014SK02

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.1 IIIA 6.2.1.1

2010



ES10C1C014JM01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 2010



ES10C1C014JM04

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2010


Métodos Servicios Agricola, Spain

ES10C1C014MT02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2010


Agrofile, Portugal

PT10C1C014MT01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 2010


Agrofile, Portugal

PT10C1C014MT02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 2010


Agrofile, Portugal

PT10C1C014MT03C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.1 IIIA 6.2.1.1

2008

What is the efficacy and selectivity of XDE-208 (GF-2032) on aphids in cucurbits grown in greenhouses in Spain


ES08C1C003MT01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 IIIA 6.1.2.1

2008

What is the efficacy and selectivity of XDE-208 (GF-2032) on aphids in cucurbits grown in greenhouses in Spain


ES08C1C003MT02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 IIIA 6.1.2.1

2008

Efficacy of XDE-208 on aphids in melon and cucumber crops. Europe, 2008

Dow Agro Sciences, France

FR08C1C065CR04C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 IIIA 6.1.2.1

2009

What is the efficacy of different sulfoxaflor analogs against aphids on cucurbit crops


EA09X03002JM01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 IIIA 6.1.2.1

2009

What is the efficacy of different sulfoxaflor analogs against aphids on cucurbit crops


ES09X03002JM03

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 IIIA 6.1.2.1

2009

Efficacy and selectivity of sulfoxaflor analogs against aphids (Aphis Gossypii/Myzus persicae) in cucurbit crops


IT09X03002LA01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.1 IIIA 6.1.2.1

2010



ES10C1C014JM02

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.1 IIIA 6.2.1.1

2010



ES10C1C014SK01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.2.1.1 2009

What is the efficacy of different sulfoxaflor analogs against aphids in cucurbits


ES09X03002SC01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2008

What is the efficacy and selectivity of XDE-208 (GF-2032) on aphids in tomato, pepper and eggplant grown in greenhouses in Spain

Métodos y Servicios Agrícolas, S.A., Spain

ES08C1C001MT01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2008


Agricultura y Ensayo, S.L., Spain

ES08C1C001MT02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.2 IIIA 6.2.1.2

2008-2009



ES08C1C001MT03C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2008-2009



ES08C1C001MT04C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2008

Efficacy of GF-2032 against Aphis spp. on vegetables

Eufrasia, Greece

GR08C1C057VA01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2008-2009

Efficacy and selectivity of XDE-208 against aphids in tomato

G.Z. S.R.L., Italy

IT08C1C103ET02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2008

Efficacy and selectivity of XDE-208 against aphids in pepper

PROAGRI S.R.L., Italy

IT08C1C104ET01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2008

Efficacy and selectivity of XDE-208 against aphids in pepper


IT08C1C104ET02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.2 IIIA 6.2.1.2

2008

Efficacy of XDE-208 against aphids in pepper

NTSZ BACS-KISKUN MEGYE, Hungary

HU08C1C125IM03C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2009

Efficacy and selectivity of sulfoxaflor analogues against aphids (Aphis gossypii / Myzus persicae /

Macrosiphum euphorbiae) in solanaceous crops

Dow Agro Sciences Italia S.r.l.

IT09X03006LA01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2010

What is the efficacy and selectivity of sulfoxaflor (GF-2626) on aphids in solanaceae crops


ES10C1C013MT01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2010

What is the efficacy and selectivity of sulfoxaflor (GF-2626) on aphids in solanaceae crops


ES10C1C013MT02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2010

What is the efficacy and selectivity of sulfoxaflor (GF-2626) against aphids in solanaceae crops

Agricultura y Ensayo, S.L., Spain

ES10C1C014MT01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.2 IIIA 6.2.1.2

2010

Efficacy and selectivity of sulfoxaflor for the control of aphids in solanaceous crops

Dow Agro Sciences Italia S.r.l

IT10C1C013AF02

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.2 IIIA 6.2.1.2

2010

Efficacy and selectivity of sulfoxaflor for the control of aphids in solanaceous crops

Dow Agro Sciences Italia S.r.l

IT10C1C013AF03

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.3 IIIA 6.2.1.3

2008

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

Fondazione Minoprio

IT08C1C109ET02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.3 IIIA 6.2.1.3

2011

Efficacy and selectivity of sulfoxaflor for the control of aphids in ornamentals

Fondazione Minoprio

IT11C1C007ET01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.3 2011


Fondazione Minoprio

IT11C1C007ET02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.3 2011


Anadiag Italy

IT11C1C007ET04C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.3 IIIA 6.2.1.3

2011


Anadiag Italy

IT11C1C007ET06C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.3 IIIA 6.2.1.3

2012

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

Fondazione Minoprio

IT12C1C013ET02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.3 IIIA 6.2.1.3

2012



IT12C1C013ET04C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.3 IIIA 6.2.1.3

2012


Anadiag Italy

IT12C1C013ET05C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.3 IIIA 6.2.1.3

2012


Fondazione Minoprio

IT12C1C013ET06C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.2.1.3 2008

Gewasveiligheid nieuwe middelen op groot assortiment

Proefcentrum voor sierteelt

BE08C1C196HE01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.4 IIIA 6.2.1.1

2007

What is the efficacy of X11422208 on white flies suspected to be resistant to neonicotinoids in vegetables in Spain

DOW AGRO SCIENCES IBERICA S.A., Spain

ES07X03008SC01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.4 IIIA 6.2.1.1

2008

Is the efficacy of XDE-208 (GF-2032) to control white fly, enhanced by the mixture of different surfactants


ES08C1C176SC01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.4 IIIA 6.2.1.1

2008

What is the efficacy and selectivity of XDE-208 (GF-2032) to control white fly in cucumber, zucchini, melon and watermelon in greenhouses in Spain


ES08C1C019JM01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.4 IIIA 6.2.1.1

2008

What is the efficacy and selectivity of XDE-208 (GF-2032) to control white fly in cucumber, zucchini, melon and watermelon in greenhouses in Spain


ES08C1C019JM02

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.4 IIIA 6.2.1.1

2009

Efficacy of sulfoximine analogues against whiteflies (Trialeurodes

vaporariorum/Bemisia tabaci) in cucurbit crops


ES09X03010JM02

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.4 IIIA 6.1.3.4

2009


vaporariorum/Bemisia tabaci) in cucurbit crops

WARWICK HRI, United Kingdom

GB09C1C031JF01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.4 2011

What is the efficacy of sulfoxaflor (GF-2626) against sap-feeding pests in cucurbit crops


IT11C1C015ET01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.4 2011


G.Z. S.R.L., Italy

IT11C1C015ET02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.4 IIIA 6.1.3.4 IIIA 6.2.1.1

2013


DOW AGRO SCIENCES ITALIA, S.r.l.

IT13C1C097ET02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.4 2011

What is the relative activity of sulfoxaflor at 2X 24 gai/ha at 7 days compared to 48 gai/ha applied once against Bemisia tabaci

METODOS SERVICIOS AGRICOLA S.A., Spain

ES11C1C015MT01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.4 2011

What is the relative activity of sulfoxaflor at 2X 24 gai/ha at 7 days compared to 48 gai/ha applied once against Bemisia tabaci

AGROTECNICA DEL SUR, S.L., Spain

ES11C1C015MT03C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.4 2011

What is the relative activity of sulfoxaflor at 2X 24 gai/ha at 7 days compared to 48 g a.s./ha applied once against Bemisia tabaci

AGROTECNICA DEL SUR, S.L., Spain

ES11C1C015MT04C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.4 2012

What is the efficacy of sulfoxaflor applied alone or tank mixed with Silwet Gold or Sylgard against whiteflies in cucurbits

ELANCO HELLAS SACI. Greece

GR12C1C021ML02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2008

What is the efficacy and selectivity of XDE-208 (GF-262) to control white fly in tomato, pepper and eggplant grown in greenhouses in Spain

Dow Agro Sciences Iberica, Spain

ES08C1C017SC01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2008



ES08C1C056SC01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2008



ES08C1C176JM01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.5 IIIA 6.2.1.2

2009


vaporariorum/Bemisia tabaci) in solanaceous crops


ES09X03009RA03

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2011

What is the relative activity of sulfoxaflor at 2x 24 g a.s./ha at 7 days compared to 48 g a.s./ha applied once against Bemisia tabaci


ES11C1C014JM01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2011

What is the relative activity of sulfoxaflor at 2x 24 gai/ha at 7 days compared to 48 g a.s./ha applied once against Bemisia tabaci

Charles River Laboratories, Spain

ES11C1C014MT01C

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2007

Efficacy of X11422208 against whiteflies in vegetables

Dow Agro Sciences Italia S.r.l., Italy

IT07C1C009LA01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2008

Efficacy and selectivity of XDE-208 against whiteflies in tomato


IT08C1C114AF01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2009

Efficacy and selectivity of sulfoxaflor analogues against whiteflies in solanaceous crops


IT09X03009AF01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.5 IIIA 6.2.1.2

2009

Efficacy and selectivity of sulfoxaflor analogues against whiteflies in solanaceous crops


IT09X03009AF02

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2011

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

Pro-agri, S.R.L., Italy

IT11C1C014ET01C

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2011


Agro Biocontrol Italy

IT11C1C014ET02C

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2011



IT11C1C014LA01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2010

Activity of 2x24 g a.s./ha of sulfoxaflor at 7 days compared to 48 g a.s./ha applied once against whiteflies in vegetable crops

Elanco Hellas SACI, Greece

GR10C1C017CM01C

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2010

Efficacy of GF-2626 against whiteflies in tomatoes

Elanco Hellas SACI, Greece

GR10C1C051CM01C

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.5 IIIA 6.2.1.2

2012

What is the efficacy of sulfoxaflor applied alone or tank mixed with Silwet gold or Sylgard against whiteflies in solanaceous crops

Dow Agro Sciences Export S.A.S., Greece

GR12C1C022VA01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2012

What is the efficacy of sulfoxaflor applied alone or tank mixed with Silwet gold or Codacide against whiteflies in solanaceous crops

Dow Agro Sciences Export S.A.S., Greece

GR12C1C059VA01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2007

Efficacy of X11422208 against flies in vegetables


IT07C1C009AF01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2008

Efficacy and selectivity of XDE-208 alone and in mix with adjuvants against whiteflies in tomato


IT08C1C137AF02

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5 IIIA 6.2.1.2

2011



IT11C1C014AF01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

IIIA 6.1.2.5

IIIA 6.2.1.2 2012



IT12C1C022AF01

GLP/GEP: Y

Published: N

N Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA 6.1.2.6 IIIA 6.2.1.3

2008

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

IT08C1C115ET01C

Fondazione Minoprio

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.6 IIIA 6.2.1.3

2008

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

Fondazione Minoprio

IT08C1C118ET02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.6 IIIA 6.2.1.3

2012

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

Dow Agro Sciences Italy IT12C1C022LA01

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.6 2013

What is the selectivity and efficacy of sulfoxaflor against whiteflies in ornamentals

Fondazione Minoprio

IT13C1C098ET01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA 6.1.2.6 2013

What is the selectivity and efficacy of sulfoxaflor against whiteflies in ornamentals

Fondazione Minoprio

IT13C1C098ET02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

IIIA1 6.1.4.2 2010

Taint test of sulfoxaflor (GF-2626) on cucurbits fruits (cucumber) cultivated under greenhouse, field and lab phases, Italy 2010

AGRI 2000 Soc. Coop. –Bologna

IT10C1C047ET01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

IIIA1 6.1.4.2 2010

Taint test of sulfoxaflor (GF-2626) on solanaceous fruits (tomato) cultivated under greenhouse, field and lab phases, Italy 2010

AGRI 2000 Soc. Coop. –Bologna

IT10C1C053ET01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

NL Addendum

III 6.1.3 2015

Field evaluation of X12317607 formulation (GF-3432) against aphids in ornamentals and flowers in open field and greenhouse

Proefcentrum voor Sierteelt, België

BE15F8B051VJ01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

NL Addendum

III 6.1.3 2015

Field evaluation of X12317607 formulation (GF-3432) against aphids in ornamentals and flowers in open field and greenhouse


BE15F8B051VJ02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

NL Addendum

III 6.1.3 2106

Field evaluation of GF-3515 formulation against aphids in ornamentals open field


BE16F8B001SB01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

NL Addendum

III 6.1.3 2016

Field evaluation of GF-3515 formulation against aphids in ornamentals and flowers in open field and greenhouse, Europe, 2016

Exploras Agro Development, The Netherlands

NL16F8B001SB01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

NL Addendum

III 6.1.3 2015

Field evaluation of X12317607 formulation (GF-3432) against whiteflies in ornamentals and flowers in greenhouse


BE15F8B052VJ02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

NL Addendum

III 6.1.3 2016

Field evaluation of GF-3515 formulation against whiteflies in ornamentals open field.


BE16F8B002SB01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

NL Addendum

III 6.1.3 2016

Field evaluation of GF-3515 formulation against whiteflies in ornamentals and flowers in open field

Exploras Agro Development , The Netherlands

NL16F8B052VJ02C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

NL Addendum

III 6.1.3 2016

Field Evaluation of X12317607 formulations against aphids in cucurbits in greenhouses

Aegisto, The Netherlands

NL16F8B010SB01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

NL Addendum

III 6.1.3 2016

Efficacy of GF-3515 against Trialeurodes vaporariorum in Cucurbits

Aegisto, the Netherlands

NL16F8B010SB01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

NL Addendum

III 6.1.3 2015

Field evaluation of X12317607 (GF-3432) against aphids in protected bell peppers

Proefstation voor de Groenteteelt, België

BE15F8B058VJ01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Part A



Netherlands

of 77



company)

Company, Report No.


relevant)


Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Study

Relied

on

Y/N

Owner

NL Addendum

III 6.1.3 2016

Field Evaluation of X12317607 formulations against aphids in solanaceous greenhouse crops

Proefstation voor de Groenteteelt, België

BE16F8B007SB01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

NL Addendum

III 6.1.3 2016

Control of whiteflies (Trialeurodes vaporariorum) in tomato with XDE-607

Proeftuin Zwaagdijk, The Netherlands

NL16F8B008SB01C

GLP/GEP: Y

Published: N

Y Y Y Dow Agro

Sciences

Annex

point

Year Title


company)

Company, Report No.

GLP or GEP status (where relevant)


Vertebrate

Study

Y/N

Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Owner

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 ground water scenarios.

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

GLP/GEP (Y/N): N

Published (Y/N): N

N Y N DAS

IIIA 9.6.1/02

2014b Predicted Environmental Concentrations of Sulfoxaflor (as product GF-2626) and its metabolites in groundwater using the FOCUS PELMO 5.5.3 model with the German National Requirements


GLP/GEP (Y/N): N

Published (Y/N): N

N Y N DAS

Part A



Netherlands

of 77

Annex

point

Year Title


company)

Company, Report No.



Vertebrate

Study

Y/N

Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Owner

IIIA 9.7/01

2014c 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


GLP/GEP (Y/N): N

Published (Y/N): N

N Y N DAS



company)

Company, Report No.



Vertebrate

Study

Y/N

Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Owner

IIIA 10.2.2.1/01 2011a GF-2626: Acute Toxicity to the

Rainbow Trout, Oncorhynchus mykiss, Determined Under Static Test Condition

Study ID: 101909

GLP/GEP (Y/N): Y

Published (Y/N): N

Y Y Y DAS

IIIA 10.2.2.2/01 2011b GF-2626: Acute Toxicity to the Water

Flea, Daphnia magna, Determined Under Static Test Conditions.

Dow Study ID: 101910

GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.2.2.3/01 2011 GF-2626: Growth Inhibition Test with

the Freshwater Diatom, Navicula pelliculosa.


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

Part A



Netherlands

of 77



company)

Company, Report No.



Vertebrate

Study

Y/N

Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Owner

IIIA 10.2.2.4/01 2011c GF-2626: Acute Toxicity to the Mysid

Shrimp, Americamysis bahia, Determined Under Static-Renewal Conditions.


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.2.6.2/01 2010 GF-2626: Acute 96 Hour Toxicity to

the Midge, Chironomus dilutus, Determined Under Static Test Conditions.


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.4.2.1/01 2010a Laboratory bioassay to determine the

acute oral toxicity of GF-2626 to the honeybee, Apis mellifera.

Dow Study ID: 10-11

GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA10.4.2.2/01 2010b Laboratory bioassay to determine the acute contact toxicity of GF-2626 to the honeybee, Apis mellifera.

Dow Study ID: 10-10

GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.4.3/01

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


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

Part A



Netherlands

of 77



company)

Company, Report No.



Vertebrate

Study

Y/N

Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Owner

IIIA 10.4.7/01 2011a Study on the Effect of GF-2626 on Honey Bee Brood (Apis mellifera L.) under Semi-Field Conditions - Tunnel Test.

Dow Study ID: 80755

GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.4.7/02 2011b Study on the Effect of GF-2626 on Honey Bees and their Brood (Apis mellifera L.) under Semi-Field Conditions - Tunnel Test


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.4.7/03 2011c Toxicity Testing of GF-2626 on Honey Bees (Apis mellifera L.) under Semi-Field Conditions - Tunnel Test.


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.4.7/04 2011 A Semi-field Study to Investigate Residues in Honeybee Products

(Apis mellifera carnica L.; (Hymenoptera, Apidae) in Phacelia tanacetifolia in Germany in 2010.

Study Code S10-01824. Dow AgroSciences unpublished report no. 2009317.

DAS Study ID: 110414.

GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.4.7/05 2016 Pre-Flowering Applications of Sulfoxaflor: Exposure and Effects on Honey bees

Document No: n.a.

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

N Y Y DAS

Part A



Netherlands

of 77



company)

Company, Report No.



Vertebrate

Study

Y/N

Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Owner

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).

Dow Study ID: 10-13.

GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.5.1/02 2010a A rate-response laboratory test to

determine the effects of GF-2626 on the predatory mite, Typhlodromus pyri (Acari: Phytoseiidae).


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

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).


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.5.2/02 2009 An extended laboratory test to

determine the effects of fresh residues of GF-2032 on the rove beetle, Aleochara bilineata (Coleoptera; Staphylinidae).


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.5.2/03 2011 A rate-response extended laboratory

test to determine the effects of GF-2626 on the green lacewing, Chrysoperla carnea (Neuroptera, Chrysopidae).


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

Part A



Netherlands

of 77



company)

Company, Report No.



Vertebrate

Study

Y/N

Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Owner

IIIA 10.5.2/04 2011 An aged-residue extended laboratory

test to determine the effects of GF-2626 on the parasitic wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae).

Dow Study ID: 10-14

GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.5.4/01 2011 A field trial to determine the effects of

GF-2372 (a 50% WG formulation of

Sulfoxaflor) on the non-target arthropod fauna of arable land after one and two applications to a wheat crop

South West France.


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.5.4/02 2011 A field trial to determine the effects of

GF-2372 (a 50% WG formulation of Sulfoxaflor) on the non-target arthropod fauna of arable land after one and two applications to a wheat crop in the Netherlands


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.6.2/01 2010a Determination of acute toxicity of GF-2626 to the earthworm Eisenia fetida in an artificial soil substrate


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.6.3/01 2010b Determination of chronic (sub-lethal) toxicity of GF-2626 to the earthworm Eisenia fetida in an artificial soil substrate.


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

Part A



Netherlands

of 77



company)

Company, Report No.



Vertebrate

Study

Y/N

Data

Protection

Claimed

Y/N

Data

Protection

Granted

Y/N

Owner

IIIA 10.6.4/01 2012 Field Study to Evaluate the Effects of Sulfoxaflor (as GF-2626 12% SC formulation) and its primary soil metabolite X11719474 on Earthworms in Southern Germany.


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.6.6/01 2010 Effects of GF-2626 on Reproduction of the Collembola Folsomia candida in Artificial Soil with 5% Peat

Dow Study ID: 101311.

GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.6.6/02 2011 GF-2626: Effects of GF-2626 on Reproduction of the Predatory Mite Hypoaspis aculeifer in Artificial Soil with 5% Peat.


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.6.6/03 2012 Field Study to Evaluate the Effects of Sulfoxaflor (as GF-2626 12% SC formulation) and its primary soil metabolite X11719474 on Soil Micro-Arthropods in Southern Germany.


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.6.7/01 2011 Field Study to Evaluate the Effects of Sulfoxaflor (as GF-2626 12% SC formulation) and its primary soil metabolite X11719474 on the Decomposition of Organic Matter in the Field.


GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

IIIA 10.7.1/01 2011 Effects of GF-2626 on the Activity of the Soil Microflora in the Laboratory

Dow Study ID: 101912 & 101917 GLP/GEP (Y/N): Y

Published (Y/N): N

N Y Y DAS

Part A



Netherlands

of 77

HET COLLEGE VOOR DE TOELATING VAN ......2015/08/29 · The Draft Assessment Report (DAR) on...

Documents

Transcript of HET COLLEGE VOOR DE TOELATING VAN ......2015/08/29 · The Draft Assessment Report (DAR) on...