1. BESLUIT - Microsoft...2013/04/29 · HET COLLEGE BESLUIT tot toelating van bovenstaand middel....

15598 N

Sivanto Prime, 20130429 ZTG

1. BESLUIT Op 25 juni 2014 is van

Bayer CropScience S.A.-N.V. Postbus 231 3640 AE MIJDRECHT

een aanvraag tot toelating van gewasbeschermingsmiddel met Nederland als zonaal rapporteur ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) voor het gewasbeschermingsmiddel

Sivanto Prime op basis van de werkzame stof flupyradifurone 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. 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.

15598 N


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 Verordening (EG) Nr. 1107/2009 Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader Conform Bgb en Rgb d.d. 16 december 2011, Evaluation Manual

Zonaal, GD Birds & Mammals 2012 en GD Dermal Absorption 2012.

3. BEOORDELINGEN

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.

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.

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Ede, 6 april 2018

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.

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN, Ir. J.F. de Leeuw Voorzitter

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BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 2.1 Aanvraaginformatie Aanvraagnummer: 20130429 ZTG Type aanvraag: Aanvraag tot toelating van gewasbeschermingsmiddel

met Nederland als zonaal rapporteur Middelnaam: Sivanto Prime Verzenddatum aanvraag: 25 juni 2014 Formele registratiedatum: * 7 juli 2014 Datum in behandeling name: 21 januari 2015 * Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan. 2.2 Stofinformatie Werkzame stof Gehalte flupyradifuron 200 G/L

• De stof is per 9-12-2015 bij Uitvoeringsverordening (EU) 2015/2084 van de Commissie goedgekeurd overeenkomstig Verordening (EG) nr. 1107/2009 en de bijlage bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 werd gewijzigd. De goedkeuring van deze werkzame stof expireert op 9-12-2025.

2.3 Toelatingsinformatie Toelatingsnummer: 15598 N Expiratiedatum: 9 december 2026 Afgeleide parallel of origineel: Origineel Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel Gebruikers: Professioneel 2.4 Verpakkingsinformatie Aard van het preparaat: Met water mengbaar concentraat

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:153:0001:0186:NL:PDF

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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel Sivanto Prime Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: Pictogram GHS07

GHS09 Signaalwoord Waarschuwing Gevarenaanduidingen H317 Kan een allergische huidreactie veroorzaken.

H332 Schadelijk bij inademing. H410 Zeer giftig voor in het water levende organismen, met langdurige gevolgen.

Voorzorgsmaatregelen P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen. P304 + P340 NA INADEMING: de persoon in de frisse lucht brengen en ervoor zorgen dat deze gemakkelijk kan ademen. P308 + P311 Na (mogelijke) blootstelling: een ANTIGIFCENTRUM/arts/... raadplegen. P501 Inhoud/verpakking afvoeren naar .... SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt.

Aanvullende etiketelementen

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 National Assessment – The Netherlands

Sivanto Prime

Registration Report – Central Zone of 223

Applicant: Bayer CropScience Evaluator: NL, Ctgb Date: March 2018

REGISTRATION REPORT

Part A

Risk Management

Product code: Sivanto Prime

Active Substance: Flupyradifurone SL 200 (200 g/L)

Country: The Netherlands Central Zone

Zonal Rapporteur Member State: The Netherlands

NATIONAL ASSESSMENT

Applicant: Bayer CropScience

Date: March 2018


Sivanto Prime


Applicant: Bayer CropScience Evaluator: Ctgb, NL March 2018

OECD Statement on Confidentiality

The summaries and evaluations contained in this monograph or review report may be based on unpublished proprietary data submitted for the purpose of the assessment undertaken by the regulatory authority that prepared it. Other registration authorities should not grant, amend, or renew a registration on the basis of the summaries and evaluation of unpublished proprietary data contained in this Monograph or review report unless they have received the data on which the summaries and evaluation are based, either: • From the owner of the data; or • From a second party that has obtained permission from the owner of the data for this purpose or,

alternatively, the applicant has received permission from the data owner that the summaries and evaluation contained in this Monograph or review report may be used in lieu of the data; or

• Following expiry of any period of exclusive use, by offering – in certain jurisdictions – mandatory compensation;

unless the period of protection of the proprietary data concerned has expired. Applicants wishing to avail of information in this Monograph or review report should seek advice from the regulatory authority to which application is made concerning the requirements in their country.


Sivanto Prime



Table of Contents

PART A – Risk Management ..................................................................................................... 10

1 Details of the application ..................................................................................... 10

1.1 Application background ...................................................................................... 10

1.2 Annex I inclusion ................................................................................................. 10

1.3 Regulatory approach ........................................................................................... 11

1.4 Data protection claims ......................................................................................... 11

1.5 Letters of Access .................................................................................................. 11

2 Details of the authorisation ................................................................................. 12

2.1 Product identity ................................................................................................... 12

2.2 Classification and labelling ................................................................................. 12

2.2.1 Classification and labelling under Regulation (EC) No. 1272/2008 ................ 12

2.2.2 R and S phrases under Directive 2003/82/EC (Annex IV and V) ................... 13

2.2.3 Other phrases ....................................................................................................... 13

2.3 Product uses ......................................................................................................... 14

3 Risk management ................................................................................................ 27

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles .............................................................................................. 27

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) ............ 27

3.1.2 Methods of analysis (Part B, Section 2, Point 5) ............................................... 27

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) ............ 27

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) ............. 27

3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) ........................................ 28

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) ..................................................... 28

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) ............................................. 28

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) ........................................... 28

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) ............................................... 29

3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) ...................... 30

3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) ................................................ 30

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) .......................................... 31

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) ...................... 31

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5) ................................................................................................ 31

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) ............................................................................................. 33


Sivanto Prime



3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) .............................................................................. 35

3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) ............................................................................................................... 37

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) . 39

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) ............................... 40

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) ............................................................................................................... 45

3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) ............................................................................................................. 46

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) ............ 47

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) . 47

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) ........................................................ 48

3.1.7 Efficacy (Part B, Section 7, Point 8) ................................................................... 48

3.2 Conclusions ........................................................................................................... 50

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 .............. 51

Appendix 1 – Copy of the product authorisation ..................................................................... 52

Appendix 2 – Copy of the provisional product label................................................................ 53

Appendix 3 – Letter of Access .................................................................................................... 64

Appendix 4 – List of data submitted in support of the evaluation ......................................... 65


Sivanto Prime



PART A – Risk Management This document describes the acceptable use conditions required for the registration of Sivanto Prime containing the new active substance flupyradifurone in The Netherlands. This application is submitted in order to allow the first approval of this product in Europe and in the Netherlands in particular. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-8 and Part C and where appropriate the addendum for The Netherlands. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information related to Sivanto Prime where that data has not been considered in the EU review. Unless otherwise indicated, assessments for the safe use of Sivanto Prime have been made using endpoints agreed in the EU review of flupyradifurone. This document describes the specific conditions of use and labelling required in The Netherlands for the registration of Sivanto Prime. Appendix 1 of this document provides a copy of the final product authorisation in The Netherlands. Appendix 2 of this document is a copy of the approved product label for The Netherlands. Appendix 3 of this document contains copies of the letters of access to the protected data / third party data that was needed for evaluation of the formulation. Appendix 4 provides a list of studies submitted in support of the evaluation.

1 Details of the application

1.1 Application background This application was submitted by Bayer CropScience SA-NV in June 2014 to the Netherlands as ZRMS for the Central zone (field uses) and Inter-zone (glasshouse uses). An updated dossier has been submitted in September 2015, taking into account the conclusions of the EFSA Peer Review (EFSA Journal 2015;13(2):4020). Please find below the address of the applicant for the Netherlands: Bayer CropScience SA-NV Energieweg 1 3641 RT Mijdrecht The Netherlands The application was for approval of Flupyradifurone SL 200 G, (trade name : Sivanto Prime) a Soluble Concentrate (SL) containing 200 grams of flupyradifurone per litre for use as an insecticide in agriculture and horticulture.

1.2 Annex I inclusion Flupyradifurone An Annex II dossier for the active substance flupyradifurone and an Annex III dossier for its representative formulation Flupyradifurone SL 200 G were submitted for the first time to the Netherlands as Rapporteur Member State (RMS) for the EU in May 2012 in order to support the approval of the flupyradifurone according to Regulation (EC) 1107/2009. A Draft Assessment Report (DAR) has been released by the RMS in January 2014. The peer review was initiated on February 2014 by dispatching the DAR for consultation of the Member States and the applicant Bayer CropScience AG. The peer review


Sivanto Prime



was finished with the publication of the EFSA conclusions (EFSA Journal 2015;13(2):4020) in February 2015. Afterward the Review Report (SANTE/11649/2015/ rev 1), was published (dated 9 October 2015). The substance has been approved under Regulation (EC) No 1107/2009 from 9 December 2015 (Commision Implementing Regulation (EU) 2015/2084).

1.3 Regulatory approach To obtain authorization of the product Sivanto Prime, the active substance must meet the conditions of EU approval under Regulation (EC) 1107/2009 and be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform Principles, using EU approval agreed end-points. This application was submitted in order to allow the first authorization of this product in The Netherlands in accordance with the above.

1.4 Data protection claims The reference list included in the dossier defines the list of studies and reports, submitted with the application, for which a claim for data protection was made. This claim for protection was made as the studies and reports were submitted and used as the basis for approval for the first time in The Netherlands. Based on Article 59 of Regulation (EC) 1107/2009 Bayer claims 10 years protection for these studies and reports. A request for additional data protection has been made by the applicant based on the application for minor uses that has been done in the present dossier. A total of 13 minor uses (crops or crop groups have been included. This concerns the following uses (LIJST KLEINE TOEPASSINGEN – based upon the DTG-lijst (versie 2.1, Ctgb 2015): Hop, Aardbei (bedekte teelt), Druif, Framboos (bedekte teelt), Sla, Courgette (bedekte teelt), Komkommer (bedekte teelt), Watermeloen (bedekte teelt), Aubergine (bedekte teelt; op het etiket gezet in de groep van "Vruchtgroenten van Solanaceae"), Bloembol-en bloemknolgewassen (bedekte teelt), Bloemisterijgewassen (niet grondgebonden onbedekte teelt), Vaste planten, Boomkwekerijgewassen (bedekte teelt en niet grondgebonden onbedekte teelt). The additional data protection would be 3 months per minor use with a maximum of 3 years. The period of data protection granted for all studies and reports is therefor 13 years (10 years regular application + 3 years for minor uses). This decision is based upon notitie Ctgb C-310.I.09 “Extra dataprotectie”, d.d. 28-02-2018. The authority confirms that these studies and reports are protected for 13 years from the data of authorisation of the product and thus cannot be used for the benefit of another applicant.

1.5 Letters of Access Flupyradifurone is solely owned by Bayer and no access to third party data is required. Moreover, a general Letter of Access has been submitted to Ctgb is which it is stated that all studies and reports belonging to Bayer AG and/or any other Bayer affiliate can be used by any interested affiliate within the Bayer Group, including but not limited to, Bayer CropScience SA-NV.

http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.ViewReview&id=971


Sivanto Prime



In Section 6 (core assessment) 2 generic field studies from BASF have been referred to. The corresponding letter of access are included in the dossier.

2 Details of the authorisation

2.1 Product identity

Product Name Sivanto Prime Flupyradifurone SL 200 (200 g/L) Specification n°102000021884-03

Authorization Number n.a. Function Insecticide Applicant Bayer CropScience SA-NV Composition 200 g/L flupyradifurone Formulation type Soluble Concentrate [Code: SL] Packaging Type: Bottle / Canister

Material: HDPE Capacity:

• Up to 10 liter: 0.25, 0.5 ,1, 3, 5 and 10 liter • Over 10 liter: 20, 25, 50, 200, 640 and 1000 liter

Type of closure and size of opening: Screw cap 36-50-63 mm (with HF seal or internal wad) - to fit container neck as defined in ECPA One Trip Container Guidelines. Tri – Sure, S 56 x 4 mm, guarantees closure. Screw cap DN 50 guarantees closure and DN 150 guarantees closure. Outer packaging Type: Corrugated fibreboard

2.2 Classification and labelling

2.2.1 Classification and labelling under Regulation (EC) No. 1272/2008 Proposal for the classification and labelling of the formulation Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labeling of the preparation is proposed:

The identity of all substances in the mixture that contribute to the classification of the mixture *:

- Pictogram: GHS07 Signal word: Warning GHS09 H-statements: H317 May cause an allergic skin reaction.


Sivanto Prime



H332 Harmful if inhaled. H410 Very toxic to aquatic life with long lasting effects. P-statements: P280 Wear protective gloves/protective clothing/eye

protection/face protection. P304+P340 IF INHALED: Remove person to fresh air and

keep comfortable for breathing. P308+P311 IF exposed or concerned: Call a POISON

CENTER/doctor/… P501 Dispose of contents/container to .... Supplemental Hazard information:

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 as proposed by applicant are accepted. Only

P309+P311 was replaced by P308+P311, since P309 was deleted in the 4th ATP. In addition, P280 also has to be assigned based on the operator exposure assessment.

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

2.2.2 R and S phrases under Directive 2003/82/EC (Annex IV and V) No additional phrases are needed.

2.2.3 Other phrases See 2.2.1.

Part B – Section 1 Core Assessment

Flupyradifurone SL 200 G Specification: 102000021884

Registration Report – All Zones of 223


2.3 Product uses

Intended indoor GAP table in the NL - Interzonal uses relate to permanently protected crops only

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

Use-No.

Member state (Central, Northern or Southern zone : C, N or S)

Crop and/ or situation (crop destination / purpose of crop)

F G or I

Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group)

Application Application rate PHI (days)

Remarks: e.g. g safener/synergist per ha Method

/ Kind Timing / Growth stage of crop & season

Max. number (min. interval between applications)

a) per use

b) per crop/season

kg, L product / ha

a) max. rate per appl.

b) max. total rate per crop/season

g, kg as/ha



Water min / max

10 NLD (C) Strawberry FRAAN G Trialeurodes vaporariorum TRIAVA; Bemisia tabaci BEMITA;

Spraying / Foliar

BBCH15-89 JAN-DEC

2 (10d)

a) 0.625 l/ha b) 1,25 L/ha

a) 0.125 b) 0,25

600 - 1000 l/ha

3 non soil-bound crops. Closed system Dose rate on the label expressed in %: 0.0625% for white fly control and aphid control max 1,25 L product per ha per 12 months

10 bis

NLD (C) Strawberry FRAAN

G Macrosiphum euphorbiae MACSEU; Chaetosiphon fragaefolii CHTSFR; Macrosiphum rosae MACSRO; Aphis forbesi APHIFO;

Spraying / Foliar

BBCH15-89 JAN-DEC

2 (10d)

a)0.5 L/ha b) 1 L/ha

a) 0.1 b) 0.2

600 - 1000 l/ha

3 non soil bound crops. Closed system Dose rate on the label expressed in %: 0.05% for white fly control and aphid control max 1,25 L product per ha per 12 months





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

Use-No.



F G or I






a) per use

b) per crop/season

kg, L product / ha



g, kg as/ha



Water min / max

11 NLD (C) Strawberry FRAAN

G Trialeurodes vaporariorum TRIAVA; Bemisia tabaci BEMITA;

Spraying / Foliar

BBCH41-89 MAR-OCT

1 a) b) 0.625 l/ha a) b) 0.125 600 - 1000 l/ha

3 Soil bound crops Dose rate on the label expressed in %: 0.0625%

for white fly control and aphid control max 0,625 L product per ha per 12 months

11 bis

NLD (C) Strawberry FRAAN

G Macrosiphum euphorbiae MACSEU; Chaetosiphon fragaefolii CHTSFR; Macrosiphum rosae MACSRO; Aphis forbesi APHIFO;

Spraying / Foliar

BBCH41-89 MAR-OCT

1 a) b) 0.5 L/ha a) b) 0.1 600 - 1000 l/ha

3 Soil bound crops Dose rate on the label expressed in %: 0.05%

for white fly control and aphid control max 0,625 L product per ha per 12 months

22 NLD (C) Raspberry RUBID G Aphis idaei APHIID; Aphis gossypii APHIGO

Spraying / Foliar

BBCH15-89 JAN-DEC

2 (10d)

a) 0.5 l/ha x m b) 1 l/ha x m

a) 0.2 b) 0,4

500l/ha x m 3 Non soil-bound crops max 2 m Dose rate on the label expressed in %: 0.1%

41 NLD (C) Aubergine SOLME G Trialeurodes vaporariorum TRIAVA; Bemisia tabaci BEMITA; Aphis gossypii APHIGO;

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.56 l/ha x m b) 1.12 l/ha x m

a) 0.225 b) 0.45

max 750 l/ha x m

3 Grown in closed system (non-soil bound) max 2 m Dose rate on the label expresse d in %: 0.075%

For the control of white flies and aphids: Total dose per ha per 12 months = 2,24 l product /ha





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

Use-No.



F G or I






a) per use

b) per crop/season

kg, L product / ha



g, kg as/ha



Water min / max

41 bis

NLD (C) Aubergine SOLME G Myzus persicae MYZUPE; Macrosiphum euphorbiae MACSEU

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.45 l/ha x m b) 0.9 l/ha x m

a) 0.180 b) 0.360

max 750 l/ha x m

3 Grown in closed system (non-soil bound) max 2 m Dose rate on the label expressed in %: 0.06%


60 NLD (C) Tomato LYPES G Trialeurodes vaporariorum TRIAVA; Bemisia tabaci BEMITA; Aphis gossypii APHIGO;

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.56 l/ha x m b) 1.12 l/ha x m

a) 0.225 b) 0.45

max 750 l/ha x m

3 Grown in closed system (non-soil bound) max 2 m Dose rate on the label expressed in %: 0.075% For the control of white flies and aphids: Total dose per ha per 12 months = 2,24 l product /ha

60 bis

NLD (C) Tomato LYPES G Myzus persicae MYZUPE; Macrosiphum euphorbiae MACSEU

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.45 l/ha x m b) 0.9 l/ha x m

a) 0.180 b) 0.360

max 750 l/ha x m

3 Grown in closed system (non-soil bound) max 2 m Dose rate on the label expressed in %: 0.06% For the control of white flies and aphids: Total dose per ha per 12 months = 2,24 l product /ha





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

Use-No.



F G or I






a) per use

b) per crop/season

kg, L product / ha



g, kg as/ha



Water min / max

80 NLD (C) Pepper CPSAN G Trialeurodes vaporariorum TRIAVA; Bemisia tabaci BEMITA; Aphis gossypii APHIGO;

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.56 l/ha x m b) 1.12 l/ha x m

a) 0.225 b) 0.45

max 750 l/ha x m



80 bis

NLD (C) Pepper CPSAN G Myzus persicae MYZUPE; Macrosiphum euphorbiae MACSEU

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.45 l/ha x m b) 0.9 l/ha x m

a) 0.180 b) 0.360

max 750 l/ha x m



100 NLD (C) Cucumber CUMSA G Trialeurodes vaporariorum TRIAVA; Bemisia tabaci BEMITA; Aphis gossypii APHIGO;

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.56 l/ha x m b) 1.12 l/ha x m

a) 0.225 b) 0.45

max 750 l/ha x m







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

Use-No.



F G or I






a) per use

b) per crop/season

kg, L product / ha



g, kg as/ha



Water min / max

100 bis

NLD (C) Cucumber CUMSA G Myzus persicae MYZUPE; Macrosiphum euphorbiae MACSEU

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.45 l/ha x m b) 0.9 l/ha x m

a) 0.180 b) 0.360

max 750 l/ha x m



116 NLD (C) Zucchini CUUPG G Trialeurodes vaporariorum TRIAVA; Bemisia tabaci BEMITA; Aphis gossypii APHIGO;

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.56 l/ha x m b) 1.12 l/ha x m

a) 0.225 b) 0.45

max 750 l/ha x m

3 Grown in closed system (non-soil bound) Dose rate on the label expressed in %: 0.075% max 2 m


116 bis

NLD (C) Zucchini CUUPG G Myzus persicae MYZUPE; Macrosiphum euphorbiae MACSEU

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.45 l/ha x m b) 0.9 l/ha x m

a) 0.180 b) 0.360

max 750 l/ha x m

3 Grown in closed system (non-soil bound) Dose rate on the label expressed in %: 0.06% max 2 m






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

Use-No.



F G or I






a) per use

b) per crop/season

kg, L product / ha



g, kg as/ha



Water min / max

130 NLD (C) Watermelon CITLA G Trialeurodes vaporariorum TRIAVA; Bemisia tabaci BEMITA; Aphis gossypii APHIGO;

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.56 l/ha b) 1,12 L/ha

a) 0.1125 b) 0,225

750 l/ha 3 Grown in closed system (non-soil bound) Dose rate on the label expressed in %: 0.075% v/v For the control of white flies and aphids: Total dose per ha per 12 months = 1,12 l product /ha

130 bis

NLD (C) Watermelon CITLA G Myzus persicae MYZUPE; Macrosiphum euphorbiae MACSEU

Spraying / Foliar

BBCH12-89 2 (10d)

a) 0.45 l/ha b) 0.9 L/ha

a) 0.09 b) 0,180

750 l/ha 3 Grown in closed system (non-soil bound) Dose rate on the label expressed in %: 0.06% v/v For the control of white flies and aphids: Total dose per ha per 12 months = 1,12 l product /ha

156 NLD (C) Flower bulbs & flower corm crops

G Aphis fabae APHIFA;

Spraying / Foliar

From BBCH11 JAN-DEC

4 (7d)

a) 0.5 l/ha b) 2 L/ha

a) 0.1 b) 0,4

500 - 1000 l/ha

n.a. Non soil-bound Dose rate on the label expressed in %: 0.05% v/v

In NL: bloembol- en bloemknolgewassen

157 NLD (C) Flower bulbs & flower corm crops

G Aphis fabae APHIFA;

Spraying / Foliar

From BBCH60 JAN-DEC

1 a) b) 0.5 L/ha a) b) 0.1 500 - 1000 l/ha

n.a. Soil-bound crops Dose rate on the label expressed in %: 0.05% v/v

In NL: bloembol- en bloemknolgewassen





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

Use-No.



F G or I






a) per use

b) per crop/season

kg, L product / ha



g, kg as/ha



Water min / max

179 NLD (C) Plants, ornamental Floricultural Plants

G Trialeurodes vaporariorum TRIAVA; Spraying / Foliar

From BBCH11 JAN-DEC

4 (7d)

a) 1.125 L/ha b) 4.5 L/ha

a) 0.225 b) 0,9

500 - 1500 l/ha

n.a. Non soil-bound . Dose rate expression on the label in % (0,075 % v/v)

In total not more than 4,5 l product/ha per 12 month for white flies and aphid control

179 bis

NLD (C) Plants, ornamental Floricultural Plants

G Aulacorthum solani AULASO; Aphis fabae APHIFA; Macrosiphum euphorbiae MACSEU; Macrosiphum rosae MACSRO; Myzus persicae MYZUPE; Myzus ascalonicus MYZUAS; Brachycaudus helichrysi ANURHE

Spraying / Foliar

From BBCH11 JAN-DEC

4 (7d)

a) 0.75 L/ha b) 3 L/ha

a) 0.150 b) 0,6

500 - 1500 l/ha

n.a. Non soil-bound Dose rate expression on the label in % (0,05 % v/v).

In total not more than 4,5 l product/ha per 12 month for white flies and aphid control

180 NLD (C) Plants, ornamental Perennials


From BBCH11 JAN-DEC

4 (7d)

a) 0.75 L/ha b) 3 L/ha

a) 0.15 b) 0,6

500 - 1000 l/ha

n.a. Non soil-bound Dose rate expression on the label in % (0,075 % v/v) In total not more than 3 l product/ha per 12 month for white flies and aphid control

180 bis

NLD (C) Plants, ornamental Perennials

G Aulacorthum solani AULASO; Aphis fabae APHIFA; Macrosiphum euphorbiae MACSEU; Macrosiphum rosae MACSRO; Myzus persicae MYZUPE; Myzus ascalonicus MYZUAS; Brachycaudus helichrysi ANURHE

Spraying / Foliar

From BBCH11 JAN-DEC

4 (7d)

a) 0.5 L/ha b) 2 L/ha

a) 0.1 b) 0,4

500 - 1000 l/ha

n.a. Non soil-bound Dose rate expression on the label in % (0,05 % v/v) In total not more than 3 l product/ha per 12 month for white flies and aphid control.





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

Use-No.



F G or I






a) per use

b) per crop/season

kg, L product / ha



g, kg as/ha



Water min / max

195 NLD (C) Tree nursery


From BBCH11 JAN-DEC

4 (7d)

a) 0,75 L/ha b) 3 L/ha

a) 0.15 b) 0,6

250 - 1000 l/ha

n.a. Non soil-bound Dose rate expression on the label in % (0,075 % v/v). In total not more than 3 l product/ha per 12 month for white flies and aphid control

195 bis

NLD (C) Tree nursery

G Myzus persicae MYZUPE; Myzus ascalonicus MYZUAS; Brachycaudus helichrysi ANURHE; Aphis fabae APHIFA;Macrosiphum euphorbiae MACSEU; Macrosiphum rosae MACSRO; Phyllaphis fagi PHYAFA

Spraying / Foliar

From BBCH11 JAN-DEC

4 (7d)

a) 0,5 L/ha b) 2 L/ha

a) 0.1 b) 0,4

250 - 1000 l/ha

n.a. Non soil-bound Dose rate expression on the label in % (0,05 % v/v). In total not more than 3 l product/ha per 12 month for white flies and aphid control





Intended outdoor GAP table in the NL

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

Use-No.



F G or I



Remarks: e.g. g safener/synergist per ha

Method / Kind

Timing / Growth stage of crop & season


a) per use

b) per crop/season

kg, L product / ha



g, kg as/ha



Water min / max

10 NLD (C) Apple MABSD F Dysaphis plantaginea DYSAPL; Rhopalosiphum insertum RHOPIN; Dysaphis devecta DYSADE Dysaphis anthrisci DYSAAN

Spraying / Foliar

BBCH10-65 MAR-MAY

a) b) 1 per 12 months

a) b) 0.4 L/ha per 12 months

a) b) 0.08 per 12 months

1000 l/ha n.a. Dose rate expression on the label in % (0.04 % v/v). On the label also set a Max. rate of 0,4 L/ha

In apple in total not more than 0.9 L product/ha per 24 months, maximum given for applications from full flowering (see use nr. 12)

11 NLD (C) Apple MABSD F Dysaphis plantaginea DYSAPL; Rhopalosiphum insertum RHOPIN; Dysaphis devecta DYSADE Dysaphis anthrisci DYSAAN Psylla mali PSYLMA

Spraying / Foliar

BBCH10-65 MAR-MAY




1000 - 1500 l/ha

n.a. Dose rate expression on the label in % (0,04 %) 2 - 3 m In apple in total not more than 0.9 L product/ha per 24 months, maximum given for applications from full flowering (see use nr. 12)

12 NLD (C) Apple MABSD F Aphis pomi APHIPO Aphis spiraecola APHISI Dysaphis plantaginea DYSAPL Hoplocampa testudinea HOPLTE Campylomma verbasci CAMYVE; Dysaphis devecta DYSADE Dysaphis anthrisci DYSAAN Psylla mali PSYLMA

Spraying / Foliar

BBCH65-79 APR-OCT




1000 - 1500 l/ha

14 Dose rate expression on the label in % (0,06 %) 2 - 3 m

In apple in total not more than 0.9 L product/ha per 24 months, maximum given for applications from full flowering (see use nr. 12)





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

Use-No.



F G or I




Method / Kind



a) per use

b) per crop/season

kg, L product / ha



g, kg as/ha



Water min / max

24 NLD (C) Pear PYUCO F Psylla pyri PSYLPI Psylla pyricola PSYLPC Dysaphis pyri DYSAPY ; Rhopalosiphum insertum RHOPIN ; Anuraphis farfariae ANURFA; Melanaphis pyraria PIRAST

Spraying / Foliar

BBCH10-65 MAR-MAY




1000 - 1500 l/ha

n.a Dose rate expression on the label in % (0,06 %) 2 - 3 m

24 bis

NLD (C) Pear PYUCO F Dysaphis pyri DYSAPY; Aphis pomi APHIPO; Aphis spiraecola APHISI Melanaphis pyraria PIRAST

Spraying / Foliar

BBCH65-79 APR-OCT




1000 - 1500 l/ha

14 Dose rate expression on the label in % (0,06 %) 2 - 3 m

35 NLD (C) Grapevine VITVI F Leafhoppers EHB

Spraying / Foliar

BBCH57-81 APR-SEP


a) b) 0.5 l/ha per 12 months


400 - 1200 l/ha

14

35 bis

NLD (C) Grapevine VITVI F Empoasca vitis EMPOVI Spraying / Foliar

BBCH61-81 a) b) 1per 12 months



400 - 1200 l/ha

14

43 NLD (C) Lettuce LACSA F Nasonovia ribis-nigri NASORN; Macrosiphum euphorbiae MACSEU; Myzus persicae MYZUPE; Aulacorthum solani AULASO; Uroleucon sonchi DACTSN; 1ACYRG Acyrtosiphon lactucae

Spraying / Foliar

BBCH12-40 MAR-OCT




200 - 800 l/ha*

3

44 NLD (C) Lettuce LACSA F Nasonovia ribis-nigri NASORN; Macrosiphum euphorbiae MACSEU; Myzus persicae MYZUPE; Aulacorthum solani AULASO; Uroleucon sonchi DACTSN; 1ACYRG Acyrtosiphon lactucae

Spraying / Foliar

BBCH41-49 MAR-OCT




500 - 800 l/ha

3

52 NLD (C) Hop HUMLU F Phorodon humuli PHODHU Spraying / Foliar

BBCH31-75 APR-SEP




2000 - 3300 l/ha

21





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

Use-No.



F G or I




Method / Kind



a) per use

b) per crop/season

kg, L product / ha



g, kg as/ha



Water min / max

58 NLD (C) Flower bulbs & corm crops Tulip, Zantedeschia, Hyacinth, Narcissus, Lily

F Aphis gossypii APHIGO; Aphis fabae APHIFA

Spraying / Foliar

From BBCH 60 APR-SEP




150 - 400 l/ha

n.a.

62 NLD (C) Plants, ornamental Perennials

F Aphis gossypii APHIGO; Aphis fabae APHIFA; Macrosiphum euphorbiae MACSEU; Myzus persicae MYZUPE; Myzus ascalonicus MYZUAS; Brachycaudus helichrysi ANURHE; Phyllaphis fagi PHYAFA

Spraying / Foliar

From BBCH 11 MAR-OCT

a) b) 4 per 12 months (7d)

a) 0.5 l/ha per 12 months b) 2 L/ha per 12 months

a) 0.1 per 12 months b) 0,4 per 12 months

300 - 1000 l/ha

n.a. Perennials, grown in containers (Non-soil bound).

62 bis

NLD (C) Plants, ornamentals Floricultural plants

F Aphis gossypii APHIGO; Aphis fabae APHIFA; Macrosiphum euphorbiae MACSEU; Myzus persicae MYZUPE; Myzus ascalonicus MYZUAS; Brachycaudus helichrysi ANURHE; Phyllaphis fagi PHYAFA

Spraying / Foliar





200 - 1000 l/ha

n.a Floricultural plants, grown in containers (Non-soil bound)

66 NLD (C) Tree nursery F Phyllaphis fagi PHYAFA; Brachycaudus helichrysi ANURHE; Myzus persicae MYZUPE; Macrosiphum euphorbiae MACSEU; Aphis fabae APHIFA Myzus ascalonicus MYZUAS

Spraying / Foliar





250 - 1200 l/ha

n.a. Grown in containers, (Non-soil bound)


Sivanto Prime



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 (Part B, Section 1, Points 2 and 4) Overall Summary: Sivanto Prime is a soluble concentrate containing 200 g/L Flupyradifurone. It is not explosive. It has no oxidizing properties. It has a flash point under atmospheric conditions higher than100°C and a self -ignition temperature of 420°C. The preparation should be regarded as being a surface active material. Its pH is within the range that naturally occurs e.g. in soil. Based on the stability data it is concluded that storage under practical and commercial conditions will not influence the technical properties of the product. The technical properties indicate that no particular problems have to be expected, when the product is used as recommended. Implications for labelling: none. Compliance with FAO specifications: The product Sivanto Prime complies with FAO specifications. Compatibility of mixtures: No tank mixes are recommended on the label and thus no tests have been performed. 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 & 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 Sivanto Prime has been provided and is considered to be acceptable.

3.1.2 Methods of analysis (Part B, Section 2, Point 5)

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)

Sivanto Prime was a representative formulation in the EU review of flupyradifurone. An analytical method and its validation for determination of flupyradifurone in Sivanto Prime were evaluated as part of the EU review of flupyradifurone. The analytical method may also be applied to other formulations containing the active ingredient flupyradifurone if the absence of chromatographic interferences is ensured. There is no CIPAC method available for the determination of flupyradifurone.

The preparation Sivanto Prime does not contain any relevant impurities formed either during manufacturing or storage of the product, therefore no specific method is required.

With respect to toxicological, eco-toxicological or environmental aspects the product Sivanto Prime does not contain any relevant formulants. Therefore, a special analytical method and validation is not needed.

All relevant data are provided and considered adequate.

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) All analytical methods are active substance data, were provided in the EU review of flupyradifurone and were considered adequate.


Sivanto Prime



3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7)

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) Sivanto Prime was the representative formulation in the EU review of flupyradifurone and has been reviewed according to Uniform Principles. The acute toxicity studies for Sivanto Prime were evaluated in the DAR. They were considered adequate. Sivanto Prime, containing 200 g/L flupyradifurone has a low acute toxicity by oral and dermal routes of exposure and low to moderate acute toxicity after inhalation (classification cat. 4). It is not irritating for skin or eyes and was found to be a skin sensitizer.

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) Sivanto Prime was the representative formulation in the EU review of flupyradifurone. The intended use pattern for national registration is much extensive than the use pattern (representative uses) considered for EU review. Therefore, an appropriate operator exposure assessment of Sivanto Prime has been provided and is considered to be adequate. The use pattern includes field and glasshouse uses. For the assessment, dermal absorption values as determined in the EU review were used, including a pro rata correction for lower in-use dilutions. The AOEL as determined in the EU was used (0.064 mg/kg bw/day).Dutch specific models were used to assess the operator exposure in the field for mechanical and manual upward and downward spraying and for spray application in the greenhouse. Based on these results there is no unacceptable risk anticipated for the operator with the intended uses of Sivanto Prime if adequate work clothing is worn and, in addition, protective gloves during mixing/loading and gloves+coverall during application for the mechanical application in hops and during manual upward application in apple, pear, grape, ornamentals and tree nursery. The following restriction sentences should be included on the label: Bij mechanische opwaartse veldtoepassing in hop dienen handschoenen en beschermende kleding gedragen te worden. Bij handmatige opwaartse veldtoepassing dienen handschoenen en beschermende kleding gedragen te worden.

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) Bystander exposure to Sivanto Prime was not evaluated as part of the EU review of flupyradifurone for all proposed use patterns. Therefore, all relevant data and risk assessments have been provided and are considered adequate. Professional bystander exposure was assessed using EUROPOEM II for the outdoor uses. For the greenhouse uses, no bystanders should be present in the greenhouse during application. Non-professional bystander and resident exposure was assessed using the German model in the core dossier and using the UK method in the national addendum. Resident exposure for the greenhouse uses was assessed using the Lee side turbulence model. Based on the exposure estimates there is no unacceptable risk anticipated for bystanders or residents when being exposed to Sivanto Prime.


Sivanto Prime



3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) Worker exposure to Sivanto Prime was not evaluated as part of the EU review of flupyradifurone for all proposed use pattern. Therefore, all relevant data and risk assessments have been provided and are considered adequate. Worker exposure for the field uses was assessed using EUROPOEM II; worker exposure for the greenhouse uses was assessed using EUROPOEM II/NL model. It is concluded that there is no unacceptable risk anticipated for the worker wearing adequate work clothing (but no PPE), when re-entering crops treated with Sivanto Prime. As a standard rule, treated crops should not be re-entered before spray deposits on leaf surfaces have completely dried.


Sivanto Prime



3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8)

3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) The product Flupyradifurone SL 200 G is a solo formulation and sought for its use on lettuce, hops, apples and pears, grapes, strawberries, raspberries, blackberries, tomatoes, eggplants, pepper, cucumber (including gherkins), zucchini, and watermelon in central and southern Europe. Full sets of field residue trials were presented in the Annex II dossier and are supported by storage stability studies, allowing the evaluation of the residue behaviour of flupyradifurone in the intended uses in the field and, where relevant, in greenhouses. Residue determinations in these crops formed the basis for MRL calculations and dietary risk assessment. Moreover, they were used to calculate the dietary burden of livestock. All national uses applied for in this dossier were equivalent or less critical than the uses submitted in the Annex II dossier. Therefore the cGAPs for Flupyradifurone SL 200 are adequately supported by the residue data already presented during the EU review. In addition, full sets of residue trials have been submitted and evaluated in this dossier to support the indoor use of Flupyradifurone SL 200 in strawberry and raspberry/blackberry. Besides the supervised residue trials on primary crops, field rotational crop trials were conducted and evaluated previously to determine the effect of previous application of flupyradifurone on following crops. In large-scale trials, using multiple rotations (simulating crop failure, re-use of the field in the same season, and re-use in the following season) and multiple crop groups (a root crop, a leafy crop, and a cereal), it was evident that total residues in all relevant food and feed matrices were generally highest in the first rotation. Subsequently, based on early draft guidance available in 2010 and as discussed with the MSs Austria and the Netherlands (RMS), further sets of rotational crop trials (single-rotation, single-crop) were conducted in tuber, stem, fruiting, bulb, and legume vegetables, pulses; and oilseeds. EFSA identified data gaps with the further sets of rotational crop trials as they were performed with a single plant back interval only, thereby representing an unrealistic situation in several crops. Nevertheless, provisionally and pending the submission of the requested data, EU MRLs were established. Livestock feeding studies were conducted with flupyradifurone in poultry and cattle in order to elucidate the levels of relevant residues in poultry and cattle tissues and in eggs and milk. These studies were evaluated previously. EFSA identified data gaps and requested feeding studies conducted with the metabolite DFA. Nevertheless, provisionally and pending the submission of the requested data, EU MRLs for animal products were derived from the evaluated feeding studies with flupyradifurone alone. As strawberries, raspberries and blackberries are no feed items, the additional uses submitted in this Draft Registration Report, do not change the dietary burden calculations performed in the Annex II dossier. In a radioactive hydrolysis study simulating processing conditions, no breakdown products of flupyradifurone above 0.5% were determined, thus confirming the residue definition's validity for use in processed commodities Additional hydrolysis studies with the metabolite DFA were not considered necessary (as agreed with the RMS) due to the chemical stability of the metabolite. In an extensive package of processing data, Processing Factors were elucidated. MRLs for the uses of flupyradifurone described in this draft Registration Report (including primary uses and rotational crops as well as residues in edible animal commodities) were summarised according to the EFSA Peer Review. MRLs were proposed for flupyradifurone, expressed as flupyradifurone, and separately for DFA, expressed as DFA. They are laid down in Regulation (EU) 2016/1902 for flupyradifurone and DFA. The requested uses can be authorized except for the indoor use of Flupyradifurone SL 200 on lettuce because the intended use would result in an exceedance of the EU MRL for DFA.


Sivanto Prime



3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) The dietary risk assessments were conducted based on total flupyradifurone residues (sum of flupyradifurone and DFA) detected in supervised residue trials. In the evaluation of the chronic dietary risk, the International Estimated Daily Intake (IEDI), calculated according to the EFSA PRIMo model (revision 2), amounts between 2% (PL general population) and 14% (WHO Cluster Diet B) of the ADI when considering the EU uses, only. As a consequence the use of flupyradifurone does not pose a chronic risk to consumers if used according to the GAPs as described in this draft Registration Report. The acute dietary risk was evaluated based on the International Estimated Short Term Intakes (IESTI) according to the EFSA PRIMo model (revision 2). Considering the requested uses of flupyradifurone only, the IESTI are highest for lettuce and melons and account for 57% and 42.5% of the ARfD, respectively (children, IESTI 1) and are therefore well below 100%. Therefore, no acute risk for consumers does arise from the uses of Flupyradifurone SL 200 as presented in this draft Registration Report. Remark:

The greenhouse use of flupyradifurone in lettuce described in this dossier (HR = 6.0 mg/kg) was not included in the calculations, as it results in an exceedance of the ARfD (108%, DE child).

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) No new studies are presented; all data were reviewed in the EU review of flupyradifurone. Appropriate endpoints from the EU review were used to calculate PECs for the active substance flupyradifurone and its metabolites in soil, surface water, ground water and air for the intended use patterns. The formulation is intended for use as an insecticide for fruits, vegetables and ornamentals in the field and in greenhouses. Therefore Core Assessments for the Central Zone (field uses) and Inter-zone (glasshouse uses) are submitted. In addition, a National Addenda for the Netherlands is presented, considering all Dutch specific requirements.

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5)

There are not specific Dutch requirements for this point. Therefore, only the conclusions of the Core assessments are described, which are also valid for the Netherlands. Core assessment – Central zone (field uses) The PEC of flupyradifurone and metabolites in soil has been assessed with a simple first tier approach (Excel sheet) assuming even distribution of the compound in upper 0-5 cm soil layer. A standard soil density of 1.5 g/cm3 was assumed. Potential long-term PECsoil

The degradation of flupyradifurone (worst-case non-normalised DFOP DT90 > 365 d) indicates a certain potential for accumulation in soil following repeated applications of flupyradifurone for multiple years Therefore, long-term soil concentrations of flupyradifurone were calculated. Generally, for long-term assessments the substance distribution in soil for annual crops with tillage should be assumed over a depth of 20 cm (i.e. lettuce, flower bulbs) and for perennial crops without tillage over a depth of 5 - 10 cm (e.g. apples, grapes, hops)


Sivanto Prime



As the use pattern is very extensive, in order to follow a risk-envelope approach only the highest PEC soil values are used for the risk assessment in the ecotoxicological section . When considering the annual application and a plateau of 5cm (for permanent crops) the maximum PECsoil following the use in pome fruits is presented in Table 3.1.5.1-1. Table 3.1.5.1-1 : Worst-case Soil concentrations of flupyradifurone following multi-year use, maximum values

used for risk-envelope approach

Use pattern Residues

distributed over …

Seasonal PECs, max, max. soil residue in

1st year

Long-term plateau / background conc.

Cmin

Long-term maximum conc.

Cmax [cm] [mg/kg] [mg/kg] [mg/kg]

Pome fruits 1 1 × 180 g/ha, 65%

5 0.084 0.084 0.168 10 0.042 0.042 0.084 20 0.021 0.021 0.042

For the metabolites, PECsoil were calculated using the approach, scenarios and application rates as for the parent compound. To follow a risk-envelope approach only the highest PEC soil values were used for the risk assessment in the ecotoxicological section. No accumulation in soil was considered, as according to their DT50

there is no potential accumulation. For the metabolites the maximum concentration was obtained for the use in lettuce (Table 3.1.5.1-2).

Table 3.1.5.1-2 : Worst-case Soil concentrations of flupyradifurone metabolites, maximum values used for risk-

envelope approach

Use pattern DFA 6-CNA

PECsoil, max [mg/kg]

PECsoil, max [mg/kg]

Lettuce 1, 1 × 125 g/ha, 25% 0.014 0.012 The results for PEC soil for the active substance and its metabolites were used for the eco-toxicological risk assessment.


Sivanto Prime



Core assessment – Inter-zone (glasshouse uses) There is no European guidance or currently agreed requirement for the assessment of exposure of a pesticide in soil used in greenhouse or indoors. A calculation of a plateau concentration is required, as the greenhouse soil may eventually be used for other purposes. Therefore, long-term soil concentrations of flupyradifurone were calculated. No long-term soil concentrations were calculated for the metabolites DFA and 6-CNA as the DT50 lab of these metabolites was <90 days. Potential long-term PECsoil

For long-term assessments the substance distribution in soil was assumed to be over a depth of 20 cm. For each crop group the worst-case use pattern was considered, this is considered to cover all uses at lower uses rates/applications a year (Table 3.1.5.1-3). The worst-case long-term concentration is for ornamentals. Table 3.1.5.1-3: Soil concentrations of flupyradifurone following multi-year use

Crop Long-term plateau / background conc. mg/kg

Strawberries 1 0.059 Strawberries 2 0.017 Raspberries 0.054 Lettuce 1 0.138 Tomato (1 crop cycle) 0.076 Tomato (2 crop cycles) 0.165 Flower bulbs 0.112 Ornamentals 1 (non-soil bound) 0.206 Ornamentals 2/Tree nursery 0.132 Ornamentals 3 0.015 Ornamentals 4 0.084

Some of these crops are only grown as non-soil bound in the Netherlands and these values, even if not relevant for the Netherlands, are presented in this summary just for completeness as they are presented in the Core assessment.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6)

This is a Dutch specific aspect. Some calculations have been included in the Core assessments as they are also EU requirements. Others, that are only Dutch specific, have been considered only in the National addenda for the Netherlands. Therefore a summary of the overall conclusions from each dRR is presented below. Central zone (field uses) Flupyradifurone The predicted environmental concentrations in groundwater (PECgw) for the active substance and metabolites were calculated in a stepwise approach: Tier 1 standard calculations and Tier 2a using time-dependent sorption (TDS), based on the simulation models PEARL and PELMO following the recommendations of the FOCUS working group on groundwater scenarios (FOCUS 2009). In the core assessment ZRMS Ctgb noted that the time dependent sorption approach was already evaluated in the DAR. During the peer review process it was concluded that the kinetic sorption experiments and its application in the exposure assessment were performed following the draft guidance. However, due to doubts on the acceptability of the draft guidance the TDS endpoints and simulations were not included in the LoEP. Ctgb was also RMS of the a.s. and is of the opinion that the TDS input parameters are suitable for risk assessment. In the core assessment ZRMS Ctgb concluded that it’s up to the Member States


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whether they will base their national authorisation on Tier 1 or Tier 2a (TDS) assessment. As Ctgb considers the time dependent sorption approach acceptable, the national assessment is based on the results from the Tier 2a groundwater assessment. Based on higher Tier 2a calculations (i.e. time dependent sorption), the PECgw values for the Kremsmunster scenario based on FOCUS_PEARL 4.4.4 calculations are below the trigger value of 0.1 µg/L for the active substance flupyradifurone, indicating an acceptable risk if the product is used according to the intended use pattern for the current formulation. However, as the predicted leachate concentration is higher than 0.01 µg/L for all proposed field uses, a general restriction for the use in groundwater protection areas has to be included on the label: Om het grondwater te beschermen mag dit product in onbedekte teelten niet worden gebruikt in grondwaterbeschermingsgebieden. For the field use in flower bulbs an additional higher tier calculation was performed using GeoPEARL 3.3.3, according to the Dutch Evaluation Manual. The same input parameters were used as in the Tier 2a (TDS) assessment. The PECgw values using GeoPEARL 3.3. are below the trigger of 0.1 µg/L for group 1&2 (Tulip, zantedeschia, hyacinth, daffodil (fine bulb)), lilly). However, as the predicted leachate concentration is higher than 0.01 µg/L the general restriction for the use in groundwater protection areas is also applicable for the use in these groups of flower bulbs. For group 3 (Gladiolus, daffodil (large bulb), other flower bulbs) the PECgw at BBCH > 60 (40% interception) is above the trigger of 0.1 µg/L Therefore, the field use in gladiolus, daffodil (large bulb) and other flower bulbs is not permissible. Metabolites: The groundwater concentration of the metabolite 6-CNA is below the trigger in any scenario for all intended uses. There are no concerns for groundwater for this metabolite. The PEC in groundwater for the metabolite DFA may exceed the 0.1 µg/L and also the 0.75 µg/L trigger; however, the concentration was < 10 µg/L in all scenarios. The relevance of the metabolite has been assessed in accordance with Sanco/221/2000 –rev.10 (2003): “Guidance Document on the Assessment of the Relevance of Metabolites in Groundwater”, and the metabolite was not relevant in terms of efficacy genotoxicity and toxicity and has also been considered in the dietary risk assessment. The non-relevance was also confirmed in the DAR and the EFSA conclusions (EFSA Journal 2015;13(2):4020). Based on the assessment, the use of Flupyradifurone SL 200 G is not expected to lead to leaching into groundwater at levels that would be unacceptable when applied according to the recommended use pattern. Inter-zone (greenhouse uses) There are currently no established European scenarios to address the groundwater risk following greenhouse uses. The applicant presented in the interzonal core assessment two greenhouse scenario’s; one for Northern Europe and one for Southern Europe. Ctgb considers these scenario’s not acceptable because it cannot be judged what the two scenario’s developed by the applicant for the soil bound greenhouse uses represent in terms of vulnerability for leaching to groundwater. Since the submission of the dRR, the Greenhouse Emission Model (GEM) has been developed according to the EFSA Guidance on protected crops (EFSA, 2014). Ctgb will use this model in the National Addendum for the national specific groundwater assessment. Therefore, Ctgb performed additional calculation s using GEM version 3.3.2.


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The PECgw values of GEM 3.3.2 were below the trigger of 0.01 µg/L for flupyradifurone and its metabolites DFA and 6-CNA for all proposed soil-bound greenhouse uses. Therefore there are no concerns for groundwater from the use of flupyradifurone in accordance with the use pattern for the current formulation. Monitoring data Flupyradifurone has not been registered yet in the Netherlands. Therefore there are no data available regarding the presence of the active substance flupyradifurone or its metabolites in groundwater.

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8)

This is a Dutch specific aspect that has been only included in the National addenda. The aquatic exposure via spray drift entry was estimated for the Dutch standard scenario via the TOXSWA simulation model, as required by the Dutch registration procedure for plant protection products.

Field uses According to the use pattern, PECsw and PECsed were calculated for the Dutch spring scenario after use in pome fruits, grapes, lettuce, hops, flower bulbs and tree nursery & ornamental plants using standard spray drift rates (Table 3.1.5.3-1). Further calculations implementing drift reducing technologies were run for the use of flupyradifurone in pome fruits, grapes, hops and tree nursery & ornamental plants. The spring scenario was selected as the worst-case (less dilution). Table 3.1.5.3-1: Maximum PECsw values of flupyradifurone and metabolites for use in different crops using

standard drift rates

Use Pattern

Compound Flupyra-difurone

BYI 02960- succinamide

BYI 02960- azabicyclosuccinamide

Drift rate [%]

PECsw [µg/L]

PECsw [µg/L]

PECsw [µg/L]

Pome fruits 1, 1 × 180 g a.s./ha, BBCH 10-65 Pome fruits 2, 1 × 180 g/ha, BBCH 65-79 Pome fruits 3, 1 × 120 g/ha, BBCH 10-65 Pome fruits 4, 1 × 80 g/ha, BBCH 10-65 Grapevine, 1 × 100 g/ha, BBCH 57-81 Lettuce, 1 × 125 g/ha, BBCH 12-49 Hops, 1 × 150 g/ha, BBCH 31-75 Flower bulbs, 1 × 100 g/ha, BBCH > 60 Tree nursery & Ornamentals, 4× 100 g/ha, BBCH >11, 7d interval

16.6 8.6

16.6 16.6 8.6 1.0 8.6 1.0 0.8

14.22 1)

7.369 9.483 6.322 4.094 0.595 6.141 0.476 1.395

6.014 3.119 4.010 2.676 1.733 0.252 2.595 0.200 0.381

3.681 1.905 2.452 1.633 1.057 0.152 1.590 0.115 0.381

1) Bold & underlined = worst-case PECsw, used as representative field PEC value (risk envelope approach) Bold values were used to define the mitigation measure for each crop

For a number of applications drift reducing technologies are necessary to secure surface water protection. For simplication, only one drift reducing technology per use pattern has been listed in the dRR. However, many others are possible according to Ctgb manual (2013 & 2014). All possibilities will be included on the product label, to give more flexibility to the growers. In the Table 3.1.5.3-2 the maximum PECsw values from example mitigation techniques are presented, based on the % drift that would be allowed in order to have a safe use.


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Table 3.1.5.3-2: Examples of drift reducing technologies and resulting max PECsw values.

Use pattern (field uses)

Examples of Mitigation measures (Drift reducing technology)

% drift of examples of mitigation measures

PECsw [µg/L]

resulting of examples of mitigations

Max % drift for safe use

Pome fruit 1, biennial 1 x 180 g/ha, BBCH 10-65

3-row sprayer, variable air support system 90% drift reducing nozzles

0.7 0.600 0.7


3-row sprayer, variable air support system 90% drift reducing nozzles

0.43 0.368 0.7


Wanner equipment, reflection shield and 90% drift reducing nozzles

0.8 0.457 1

Pome fruit 4, 1 x 80 g/ha, BBCH 10-65

Venturi nozzle (90% drift reduction) + one-sided spray in last row + reduced air fan setting

1.3 0.495 1.6

Grapevine, 1 x 100 g/ha, BBCH 57-81

Tunnel sprayer 1.3 0.619 1.3

Lettuce, 1 x 125 g/ha, BBCH 12-40 and 41-49

No additional mitigation measures required *

n.a. n.a. 1% (standard for field crops)

Hops, 1 x 150 g/ha, BBCH 31-75

95% drift reducing nozzle and one-side spraying of the last tree row

0.8 0.571 0.86

Flower bulbs, 1 x 100 g/ha, BBCH > 60

No additional mitigation measures required*

n.a. n.a. 1% (standard for field crops)

Ornamentals / Tree nursery 4 x 100 g/ha, BBCH > 11, 7d interval

Axial sprayer + 50% drift reducing nozzles (considering 5m buffer to surface water)

0.32 0.558 0.35

*In the Netherlands, for field crops it is compulsory (by law) to use at least 50% drift reducing nozzles + end nozzles. It is assumed that this standard situations results in 1% drift Greenhouse uses The drift rate used for calculations was 0.1% for greenhouse applications, according to Ctgb Evaluation Manual (Table 3.1.5.3-3). As flupyradifurone is intended for uses from spring to autumn, the Dutch standard ditch scenario for spring applications was taken into account for calculations as a worst case.


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Table 3.1.5.3-3: Maximum PECsw values of flupyradifurone and metabolites for use in greenhouse crops

Crop

Maximum application

rate

Application interval

Flupyra-difurone

BYI 02960-succinamide

BYI 02960- azabicyclo-

succinamide PECsw PECsw PECsw

[g a.s./ha] [days] [µg/L] [µg/L] [µg/L] Strawberry 1 2 × 125 10 0.111 0.049 0.030 Strawberry 2 1 × 125 - 0.059 0.025 0.015 Raspberry 2 × 200 10 0.177 0.078 0.048 Fruiting vegetables a) 2 × 225 10 0.200 0.088 0.054 Watermelon 2 × 112.5 10 0.100 0.044 0.027 Lettuce 1 × 125 - 0.059 0.025 0.015 Flower bulbs 1 4 × 100 7 0.168 0.076 0.047 Flower bulbs 2 1 × 100 - 0.048 0.020 0.012 Ornamental plants 1 4 × 225 7 0.380 0.172 0.106 Ornamental plants 2 & Tree nursery 4 × 150 7 0.253 0.115 0.070

Bold values (worst-case) were used for risk assessment as representative greenhouse PEC (risk envelope approach)

The results for PEC surface water for the active substance and its metabolites were used for the eco-toxicological risk assessment. Monitoring data As flypyradifurone has not been registered yet in the Netherlands, there is no monitoring data available over the presence of flupyradifurone on groundwater and surfacewater. Drinking water criterion In accordance with the national requirements the predicted environmental concentration in drinking water, abstracted from surface water in the Netherlands using the simulation model FOCUS TOXSWA with the D3 FOCUSsw scenario in combination with the software tool DROPLET have been calculated. For the contribution of the greenhouse uses a conservative approach from the interim decision tree was used. The results show that the drinking water standard of 0.1 µg/L is not exceeded at none of the abstraction points. Therefore it can be concluded that the intended use patterns for flupyradifurone (field and greenhouse uses) 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)

Core assessments – Central and Inter-zone Based on the results of vapour pressure and Henry’s law constant determination it is concluded that significant volatilization of flupyradifurone in the environment is not expected. If flupyradifurone enters the atmosphere it would be rapidly degraded with a half-life of 13.1 hours (long-term scenario).


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Implications for labelling resulting from environmental fate assessment: In order to protect groundwater, the following restrictions will be added to the label: Om het grondwater te beschermen mag dit product in onbedekte teelten niet worden gebruikt in grondwaterbeschermingsgebieden


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3.1.6 Ecotoxicology (Part B, Section 6, Point 10)

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) Birds Core assessment – Central zone (field uses). Flupyradifurone SL 200 G was a representative formulation in the EU review of flupyradifurone. Active substance data on toxicity to birds is used for the risk assessment. Data on the formulation is also provided and it can be concluded that the formulation is not more toxic that the active substance. This data has been reviewed and the resulting risk assessments are considered adequate. The risk assessment procedure follows the EFSA Guidance Document on Risk Assessment for Birds & Mammals (2009). The risk assessment follows a tiered approach to assess the effects of plant protection products on birds. The acute, short-term and long-term risks of Flupyradifurone SL 200 G to birds were assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with the active substance, and maximum residues occurring on food items following applications according to the proposed use pattern. Risk of secondary poisoning has not been assessed, as neither the active ingredient nor any of its metabolites has a log Pow above 3. Hence the potential of bioaccumulation is considered to be very low. The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute and short-term risk and 5 for long-term risk, thus indicating no unacceptable risk to birds from the proposed use. There is a potential risk where birds may drink contaminated water from leaf whorls. Birds have been observed drinking from leaf axils only under conditions of water shortage, i.e. during extended periods of drought weather, when the fields are spray irrigated resulting in the availability of water. It should also be noted that water pools in leaf axils are only relevant in leafy vegetables at BBCH stages > 40. A number of mitigation options are presented, at the most basic ensuring that the concentration in the spray solution is < 0.025 kg as/hL. Core assessment – Interzone (greenhouse uses). As birds are unlikely to be exposed to the formulation following a use in greenhouse, no risk assessment was performed for direct exposure via sprayed food. The potential risk via eating foliar insects that feed from plants that are transferred to outdoors after treatment (possible for ornamentals and tree nursery) is considered addressed because no risk was found in the first tier for the field uses in ornamentals and tree nursery (described in the field core), which can be considered worst case for the greenhouse uses. As neither the active ingredient nor any of its metabolites has a log Pow above 3, the potential of bioaccumulation is considered to be very low. Additional considerations for national addenda – The Netherlands No risk to birds resulted from exposure via drinking water (see Core document), except for field application to lettuce at BBCH > 40 in the core assessment. A restriction sentence has been added to the product label to address this risk: Om de vogels te beschermen moet Sivanto Prime in sla (onbedekte teelt) worden toegepast met minimaal 500 L water/ha, indien het wordt toegepast vanaf kropvorming of oogstbare gedeelte (BBCH 41 – 49). De concentratie van de werkzame stof in de spuitvloeistof mag niet meer dan 0,025 kg a.s./hL zijn. Terrestrial vertebrates (other than birds)


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Core assessment – Central zone (field uses). Flupyradifurone SL 200 G was a representative formulation in the EU review of flupyradifurone. Active substance data on toxicity to mammals is used for the risk assessment. Data on the formulation is also provided and it can be concluded that the formulation is not more toxic that the active substance. This data has been reviewed and the resulting risk assessments are considered adequate. The risk assessment procedure follows the EFSA Guidance Document on Risk Assessment for Birds & Mammals (2009). The risk assessment follows a tiered approach to assess the effects of plant protection products on mammals. The acute and long-term risks of Flupyradifurone SL 200 G to wild mammals were assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with the active substance flupyradifurone, and maximum residues occurring on food items following applications according to the use pattern. Risk of secondary poisoning has not been assessed, as neither the active ingredient nor any of its metabolites has a log Pow above 3. Hence the potential of bioaccumulation is considered to be very low. The acute TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute risk, thus indicating no unacceptable risk to mammals from the proposed use. Long term TER values for exposure to treated crops were above the corresponding Annex VI trigger of 5 in the first tier, indicate acceptable long-term risk, except for the herbivorous mammal vole in pome fruit, lettuce, hops, flower bulbs and tree nursery, and for the frugivorous mammal dormouse in pome fruit. Refinements of ftwa were applied for common vole based on residue decline trials in lettuce and cereals and for dormouse based on residue decline trials in apples. In addition, a refined endpoint (BMDL10) was used in the higher tier assessment. These refinements resulted in all long term TERs being above the trigger of 5, indicating acceptable risk to mammals for all proposed uses. Acceptable risk to mammals will result from exposure via drinking water . The risk from metabolites to mammals is considered to be low. Core assessment – Interzone (greenhouse uses). As mammals are unlikely to be exposed to the formulation following a use in greenhouse, no risk assessment was performed for direct exposure via sprayed food. Additional considerations for national addenda – The Netherlands Not necessary.

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) The aquatic toxicity profile of the active substance flupyradifurone, its aquatic metabolites and the formulated product Flupyradifurone SL 200, shows, that the sediment dweller (Chironomus riparius) and the mysid shrimp (Americamysis bahia), were the most sensitive species. The acute endpoint derived from a study with the active substance on C. riparius (EC50 = 61.7 µg/L, assessment factor = 100 for acute risk) delivers the lowest Regulatory Acceptable Concentration. In view of the information on the toxicity of neonicotinoids to aquatic insects summarised in the section on the risk assessment for aquatic organisms (including the recent peer reviewed paper from 2016), and the similar toxicity profile and working mechanism of flupyradifurone compared to neonicotinoids, the ZRMS considers that the EFSA conclusion of flupyradifurone should be revised and that additional toxicity data on sensitive aquatic insects (Ephemeroptera, Plecoptera and Trichoptera) should be required. The ZRMS has send the new information to EFSA and has asked them to start a peer review round as soon as possible. However, EFSA did not receive a mandate from COM for this (October 2017). We asked the opinion of concerned member states on this. Five countries responded. Two were against asking


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for more data, one requested more information (which is provided in this RR) and two were in favour, with one stating specifically that they consider it an issue for their national authorisation. This is valuable input for further discussions on this issue with EFSA and/or Commission. However, it does not have consequences for the current application, since this is based on the harmonised EU endpoints. Core assessment – Central zone (field uses). For most proposed uses, risk mitigation (FOCUS Step 4, including buffer zones and drift mitigation nozzles) is necessary. For one use in lettuce, the risk was not resolved even at FOCUS Step 4 despite considering the highest possible drift mitigation measures; this use is referred to MS level. Core assessment – Interzone (greenhouse uses). The risk to aquatic organisms is acceptable without the need for drift mitigation measures. Additional considerations for national addenda – The Netherlands Field uses: The risk assessment based on country specific requirements revealed TER values above the required triggers for fish, invertebrates, algae and higher aquatic plants following a risk envelope approach based on the overall worst-case PEC of all field crops. TER calculations for the most sensitive species (C. riparius, acute exposure) were used to define the mitigation measures (i.e. drift reducing technology) needed for the field uses in high fruit crops, grapevine, hops, ornamentals and tree nursery. One table is made in which the measures for aquatic organisms and terrestrial non-target arthropods are combined. In this table, the new Activity Decree is taken into account. For the field uses in lettuce and flower bulbs, no mitigation measures are needed. Greenhouse uses: The risk assessment based on country specific requirements revealed TER values above the required triggers for all aquatic organisms following a risk envelope approach based on the overall worst-case PEC of all greenhouse crops. No mitigation measures are required for the greenhouse uses. The following should be included on the Dutch label: Om in het water levende organismen en niet tot de doelsoorten behorende geleedpotigen te beschermen is toepassing uitsluitend toegestaan indien op het gehele perceel gebruik wordt gemaakt van één van de volgende driftreducerende maatregelen: Toepassingsgebied

Maximale dosering (middel) per toepassing

Driftreducerende maatregelen op percelen die grenzen aan oppervlaktewater

Driftreducerende maatregelen op percelen die niet grenzen aan oppervlaktewater

Hop 0,75 L/ha

• Een techniek uit tenminste de klasse DRT99, of:

• Een techniek uit tenminste de klasse DRT95 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de insteek van de sloot)

• Een techniek uit tenminste de klasse DRT99, of

• Een techniek uit tenminste de klasse DRT95 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens)

Appel

0,4 L/ha Toepassing vóór 1 mei

• Een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de insteek van de

• Een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens), of;


Sivanto Prime



Toepassingsgebied




sloot), • Een techniek uit tenminste de klasse

DRT95

• Een techniek uit tenminste de klasse DRT99, of;

• Een tunnelspuit 0,6 L/ha Toepassing vóór 1 mei

• Een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de insteek van de sloot), of;

• Een techniek uit tenminste de klasse DRT 99


• Een techniek uit tenminste de klasse DRT99

0,9 L/ha Toepassing vanaf 1 mei



• Een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens), of:

• Een tunnelspuit, of; • Een windhaag op de rand van het

rijpad in combinatie met éénzijdige bespuiting van de laatste bomenrij in de richting van het perceel

Peer 0,9 L/ha Toepassing vóór 1 mei





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Toepassingsgebied







• Een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens), of:


rijpad in combinatie met éénzijdige bespuiting van de laatste bomenrij in de richting van het perceel

Druif 0,5 L/ha • Een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 300 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de insteek van de sloot of de perceelgrens), of;

• Een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de insteek van de sloot of de perceelgrens), of;


rijpad in combinatie met éénzijdige bespuiting van de laatste gewasrij in de richting van het perceel

• Een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 300 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan tot aan de perceelgrens), of;

• Een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens), of:


rijpad in combinatie met éénzijdige bespuiting van de laatste gewasrij in de richting van het perceel

Bloembol-en bloemknolgewassen (onbedekte teelt)

0,5 L/ha • Geen additionele maatregelen nodig • een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 125 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens)

Bloemisterijgewassen (niet grondge

0,5 L/ha • een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 175 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant

• een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 175 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in


Sivanto Prime



Toepassingsgebied




bonden onbedekte teelt)

in de rij tot aan de insteek van de sloot of de perceelgrens), of;

• in geval van handmatige bespuiting (rugspuit/spuitlans) een afschermkap met inachtneming van een teeltvrije zone van tenminste 300 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de insteek van de sloot)

de rij tot aan de perceelgrens) • in geval van handmatige bespuiting

(rugspuit/spuitlans) een afschermkap

Boomkwekerijgewassen (niet grondgebonden onbedekte teelt)

0,5 L/ha • in geval van een neerwaartse bespuiting een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 175 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de insteek van de sloot of de perceelgrens), of;

• in geval van handmatige neerwaartse bespuiting (rugspuit/spuitlans) een afschermkap met inachtneming van een teeltvrije zone van tenminste 300 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de insteek van de sloot)

• in geval van een zij-/opwaartse bespuiting (laanbomenteelt) een techniek uit tenminste klasse DRT50

• in geval van een neerwaartse bespuiting een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 175 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens), of;

• in geval van handmatige neerwaartse bespuiting (rugspuit/spuitlans) een afschermkap

• in geval van een zij-/opwaartse bespuiting (laanbomenteelt) een techniek uit tenminste klasse DRT50 in combinatie met een totale teeltvrije zone van 500 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens). In deze teeltvrije zone mogen gewassen geteeld worden van tenminste dezelfde hoogte als het te bespuiten gewas, waarin geen gewasbeschermingsmiddelen worden gespoten

Vaste plantenteelt (niet grondgebonden, onbedekte teelt)

0,5 L/ha • een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 175 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de insteek van de sloot of de perceelgrens), of;

• in geval van handmatige bespuiting (rugspuit/spuitlans) een afschermkap met inachtneming van een teeltvrije zone van tenminste 300 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant

• een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 175 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens)

• in geval van handmatige bespuiting (rugspuit/spuitlans) een afschermkap


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Toepassingsgebied




in de rij tot aan de insteek van de sloot)

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)

Bees Core assessment – Central zone (field uses). The hazard quotients for oral exposure exceed the trigger value (QHO > 50) based on the endpoint derived from the study with technical flupyradifurone. The hazard quotients for contact exposure were always below the trigger of 50. All off-field HQ values were below 50, indicating acceptable off-field risk to bees. Semi-field and field studies indicated that flupyradifurone can be applied at foliar application rates of up to and including 200 g flupyradifurone a.s./ha, even to bee-attractive, full-flowering crops during honey bees actively foraging, without adverse effects on honey bees, honey bee brood and honey bee colonies. These studies cover all uses. Core assessment – Interzone (greenhouse uses). Lettuce is not a flowering crop and bee exposure via the flowers is therefore not relevant, nor are flowering weeds considered to be a relevant exposure route in greenhouses. The hazard quotient for contact exposure is below the empirical trigger value for higher tier testing (HQC <50) for all remaining uses. The hazard quotients for oral exposure exceed the empirical trigger value for higher tier testing (HQO > 50). Therefore, a refined risk assessment was conducted for honey bees entering the greenhouse. Off-field exposure to flowers outside the greenhouse is not expected from applications in greenhouses. Based on semi-field and field studies, the risk is acceptable. Additional considerations for national addenda – The Netherlands The risk assessment for the off-field risk from the field uses has been included in the National Addendum, as this is a specific Dutch requirement, which employs Dutch specific drift values. All off-field HQ values were below the trigger of 50 indicating no concern, except for the use in pome fruit, early (before 1st May, with no leaves) at 180g/ha (HQ 56). However, for this use the off-field risk is also acceptable since Higher tier semi-/field- and field studies presented in the core assessment indicate no effect even considering spray application of 200g/ha into flowering crops during foraging. For the greenhouse uses an off-field assessment is not relevant. Post assessment note : During the commenting round, one cMS highlighted that for their national assessment they will ask for additional information regarding issues from several studies that they have or know of at their national level. These issues concern the potential long-term presence of residues in honeybee colonies and of a potential increased toxicity when Sivanto is applied together with azole fungicides. Member States may consider the issues mentioned by Germany for their national authorisations. The zRMS has contacted the applicant and asked for the studies. The applicant provided these studies to the Ctgb. If they lead to changes in the current risk assessment of Sivanto Prime, we will inform the cMS. Other non-target arthropods Core assessment – Central zone (field uses).


Sivanto Prime



In-field No tier 1 in-field assessment was performed due to the low LR50 on glass plate for A. rhopalosiphi (<0.5 g a.i./ha). The tier 2 in-field risk assessment for C. septempunctata, A. bilineata and T. pyri indicates that no unacceptable adverse effects are to be expected in the in-field area for arthropod species with a similar sensitivity as these speciesbut for T. pyri a refined risk assessment is required for the use in hops and ornamentals/tree nursery (non-soil bound). In addition, for A. rhopalosiphi a refined risk assessment is required for all intended uses, since initial effects in the in-field area cannot be excluded for this species. Since the LR50 of 177 g a.i./ha for T. pyri exceeds the maximum in-field rate in hops of 150 g a.i./ha and that at the rate of 142 g a.i./ha no adverse effect on reproduction was observed (effect -6.8%, i.e. a slight increase relative to the control), it is unlikely that at the 5% higher rate of 150 g a.i./ha in hops reproduction effects above 50% will occur, hence the risk to predatory mites in hops is acceptable. Aged residue studies with A. rhopalosiphi and O. laevigatus indicate that the potential for recovery is given even after 2 applications at a rate of 250 g a.i./ha within 7 weeks for the most sensitive species, A. rhopalosiphi. For O. laevigatus, residues aged for only 4 weeks already had no adverse effect on mortality and reproduction. These studies cover all intended uses. Off-field The Tier 2 off-field risk assessment indicated that the risks are acceptable for T. pyri, C. septempuctata and A. bilineata, but that for Aphidius initial effects cannot be excluded for all intended uses. The refined off-field risk assessment was based on the NOEAER of 5.1 g a.i./ha as from field studies and indicated that no unacceptable adverse effects on non-target arthropods are to be expected in off-field habitats following the use of the product according to the proposed use pattern, provided that the appropriate mitigation measures for a reduction of the off-field esposure (buffer zones or application with drift reducing technic) are considered for the use in pome fruit, grapevine, hops, tree nursery and ornamentals/tree nursery (non-soil bound). Core assessment – Interzone (greenhouse uses). As there is no off-field exposure, only beneficial arthropods within the greenhouse are at risk. Based on the available data the risk to non-target arthropods is potentially high. Effects in the laboratory and extended laboratory studies are seen at around 1 g a.s/ha. In the two field studies, the NOERpopulations were 1.7 and 5.1 g a.s./ha. Thus, even at much lower doses than proposed in the GAP, effects on non-target arthropods will occur. Therefore, populations of natural enemies present in greenhouses may be adversely affected. MS should consider the need for a warning sentence. Additional considerations for national addenda – The Netherlands An off-crop assessment is required due to Dutch specific drift rates. The risk assessment indicated that no unacceptable adverse effects on non-target arthropods are to be expected for the off-field habitats following the use of the product according to the proposed use pattern, provided that appropriate drift reducing technology is applied to mitigate the risk for non-target arthropods in the off-field area (for details please see section 3.1.6.2 above). Regarding Integrated Pest Management (IPM), taken into account that in higher-tier tests, >25% effects were observed for the maximum doses rates, for one or more species, a warning phrase will be added to the product label: Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg deskundigen (uw leverancier van natuurlijke vijanden, de producent van dit middel, uw adviseur) over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden.

3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6)

Core assessment – Central zone (field uses). The acute and long-term TER of flupyradifurone, Flupyradifurone SL 200 and metabolites DFA and 6-CNA for earthworms and the long-term TER values of Flupyradifurone SL 200 and metabolites DFA and


Sivanto Prime



6-CNA for soil non-target macro-organisms, i.e. collembola, soil mites, are all above the trigger of concern, indicating no unacceptable risk for earthworms and soil non-target macro-organisms. Core assessment – Interzone (greenhouse uses). There is no European guidance or currently agreed requirement for the assessment of exposure of a pesticide in soil used in greenhouses. Since the greenhouse soil may eventually be used for other purposes, exposure of earthworms and other soil non-target macro-organisms and effects on organic matter breakdown may be relevant for persistent substances. This is relevant for flupyradifurone. For both acute and reproductive risk, TERs for earthworms based on long-term soil concentrations are above the relevant trigger values of 10 and 5, and long-term TERs for soil macro-organisms were above the trigger of 5. Therefore, the risk for earthworms and soil mesofauna other than earthworms is acceptable for the intended uses. The annual rate of 265-300 g a.s./ha shown to be without long-lasting effects on organic matter breakdown corresponds with a PECsoil of 0.35-0.40 mg/kg soil d.w. (based on incorporation into the top 5 cm, and soil density 1.5 g/cm3). This rate is above the worst case PECsoil,plateau of 0.206 mg/kg soil d.w. Therefore the effects on organic matter breakdown of the proposed uses are considered to be acceptable. Additional considerations for national addenda – The Netherlands None.

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) See 3.1.6.4.

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

Core assessment – Central zone (field uses). NOECs of flupyradifurone and Flupyradifurone SL 200 (3.8 and 3.335 mg a.s./kg soil d.w., respectively) were clearly above the expected exposure in soil (0.68 mg a.s./kg soil d.w.). The NOEC of the metabolite 6-CNA for microbial N-turnover (1.33 mg/kg soil d.w.) was determined to be 111-fold higher than the worst case PEC in soil for 6-CNA (0.012 mg/kg soil d.w.). The high margin of safety indicates that microbial C-turnover is not at risk due to formation of 6-chloronicotinic acid in soil. Assuming a 10-fold higher toxicity of DFA in comparison with to 6-CNA with regard to microbial C- and N-turnover, the risk could still be considered as acceptable.

Overall, it can be concluded that the functioning of soil micro-organisms is not at risk if Flupyradifurone SL 200 is applied according to the recommended use pattern. Core assessment – Interzone (greenhouse uses). Since the greenhouse soil may eventually be used for other purposes, effects on on soil non-target micro-organisms may be relevant for persistent substances such as flupyradifurone. The worst case NOEC for flupyradifurone and Flupyradifurone 200 SL (3.335 mg a.s./kg soil d.w.) is a factor of 16 higher than the worst case PECsoil,plateau of 0.206 mg/kg soil d.w. Therefore the effects on soil non-target micro-organisms of the proposed uses are considered to be acceptable. Additional considerations for national addenda – The Netherlands None.


Sivanto Prime



3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8)

Core assessment – Central zone (field uses). The risk assessment was based on the findings of the seedling emergence study and the vegetative vigour study. The lowest endpoint obtained from these studies is > 410 g a.i./ha. According to the results of the risk assessment all TERs are above the trigger of 5 with conventional spraying equipment. Therefore, no unacceptable risk to non-target plants is to be expected and no mitigation is necessary. Core assessment – Interzone (greenhouse uses). Since non-target plants are non-crop plants located outside the treated area (off-crop) (i.e. outside the greenhouse), it is expected that the application of the product according to the intended use pattern will not lead to a contamination of non-target plants via overspray. However, since the greenhouse soil may eventually be used for other purposes, effects on non-target plants may be relevant for persistent substances such as flupyradifurone. For several of the soil-bound uses, the TER is below the trigger of 5 (3.3-4.7). However, the PEC calculations can be considered worst case and the ER50 is a >-value, therefore under practical conditions the risk is assumed to be acceptable for all uses. Additional considerations for national addenda – The Netherlands Based on the risk assessment according to Dutch requirements using Dutch specific drift rates the risk for non-target terrestrial plants is considered acceptable for all intended field uses without mitigation measures, when the product is applied according to the recommended use pattern, according to good agricultural practice. Other non-target species (Flora and Fauna) The spectrum of the biological activity of the product is well represented by the results and the risk assessments included in the dossier. Therefore, further data from biological primary screening or other preliminary tests are not considered relevant for the risk assessment.

3.1.7 Efficacy (Part B, Section 7, Point 8) Field, Central zone Minimum effective dose tests Minimum effective dose tests are not available on all crops and targets supported in the dossier, but major pests and major crops are well represented and therefore data is sufficient to determine the minimum effective dose rate. Most minimum effective dose trials are carried out in the Maritime climate zone. Based on the results of the minimum effective dose trials it is possible to conclude that the proposed dose rates for the pests according the GAP in lettuce, hop, pome fruit, grapes, flower bulbs, ornamentals (floriculture crops and perennials) and tree nursery crops are justified. Effectiveness Most efficacy trials are carried out in the Maritime climate zone. The available information is sufficient for evaluating the effectiveness of Sivanto Prime against leaf aphids in lettuce, hop, pome fruit, grapes, flower bulbs, ornamentals (floriculture crops and perennials) and tree nursery crops. The effectiveness of Sivanto Prime was in general comparable to the effectiveness of the reference treatments.


Sivanto Prime



Yield and quality The proposed use of Sivanto Prime has no negative effect on the yield and quality of hop, pome fruit, wine grapes, lettuce and flower bulbs. The available information is sufficient to evaluate the effects of Sivanto Prime on yield and quality. From the trials concerning the impact on the quality of plants and plant products, concerning the effects on the processing procedure, and concerning the effects on the yield of treated plants and plant products it can be concluded that an application of Sivanto Prime according to the recommended use will not cause any unintentional adverse effects. Phytotoxicity The available information is sufficient for the evaluation of the phytotoxicity of Sivanto Prime for the Central registration zone. Information from a broad range of crops under field conditions from the Maritime, North-east and South-east zone is available and also from crops under protected conditions, which are more susceptible. For ornamentals, memberstates should consider including a label warning for transient phytotoxicity on the label. This is especially relevant as the number of species and varieties in ornamentals is large and not all of them can be tested. It can be concluded that the proposed uses of Sivanto Prime in lettuce, hop, pome fruit, flower bulbs, tree nursery, ornamentals and grapes are safe. Protected, Inter-zonal Minimum effective dose Minimum effective dose tests are not available on all crops and targets supported in the dossier, but major pests and major crops are well represented and therefore data is sufficient to determine the minimum effective dose rate. Based on these statements and results of the minimum effective dose trials it is possible to conclude that the proposed dose rates for the pests according the GAP in lettuce, fruiting vegetables, raspberry, strawberry and floriculture crops are justified. No trials were submitted to support the dose rate under protected conditions in bulb flowers and tree nursery crops. The applicant proposes extrapolation from floriculture crops, this should be confirmed on national level. Effectiveness The available information is sufficient for evaluating the effectiveness of Sivanto Prime against leaf aphids in lettuce, fruiting vegetables, strawberry, raspberry, floriculture crops and and for evaluating the effectiveness of Sivanto Prime against whiteflies in fruiting vegetables, strawberry and floriculture crops (T.vaporariorum). For some crops such as tree nursery (T. vaporariorum) and flower bulbs (T. vaporariorum) the claim is based on extrapolation from floriculture crops. Efficacy against B. tabaci is not proven in ornamentals, flower bulbs and tree nursery crops. Efficacy against A. gossypii in protected ornamentals, flower bulbs and tree nursery crops is not proven. The effectiveness of Sivanto Prime was in general comparable to the effectiveness of the reference treatments. Yield and quality The proposed use of Sivanto Prime has no negative effect on the yield and quality of tomatoes, lettuce, raspberries and strawberries. The available information is sufficient to evaluate the effects of Sivanto Prime on yield and quality. From the trials concerning the impact on the quality of plants and plant products, concerning the effects on the processing procedure, and concerning the effects on the yield of


Sivanto Prime



treated plants and plant products it can be concluded that an application of Sivanto Prime according to the recommended use will not cause any unintentional adverse effects. Phytotoxicity The available information is sufficient for the evaluation of the phytotoxicity of Sivanto Prime in fruiting vegetables, lettuce, strawberries, tree nursery, ornamentals and flower bulbs under protected conditions. The available information for raspberries is limited. However, given the fact that no phytotoxicity was found in the raspberry effectiveness trials, and the amount of data in the other (more sensitive) crops, the available information for raspberries is also sufficient. In cucumber some phytotoxicity symptoms were found, and as a consequence a warning sentence is needed. In addition, the trials in fruiting vegetables were not carried out in worst case situation (dark period). Therefore a warning sentence for fruiting vegetables should be placed on the label. On the Dutch label the following sentence is written: Een toepassing in de teelt van komkommer kan gewasschade tot gevolg hebben. In vruchtgroenten is de gewasveiligheid in de wintermaanden niet onderbouwd, voer een proefbespuiting uit voor het middel op grote schaal toegepast wordt. In addition transient phytotoxicity was found in ornamentals, the following warning should be added to the label. In bloemisterijgewassen kan enige tijdelijke gewasschade optreden. 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. It can be concluded that the proposed uses Sivanto Prime is safe in lettuce, raspberries, strawberries, tree nursery, ornamentals and flower bulbs under protected conditions. Resistance management Sivanto Prime contains the active substance flupyradifurone. Flupyradifurone is a new active substance, which belongs to the chemical group of butenolides. It belongs to the IRAC (Insecticide Resistance Action Comity) group 4D (a new group) which includes the insecticidal antagonists of the nAChR. According to the IRAC, resistance management is required. Altogether, the restriction of a maximum of one to four applications, depending on the use, per year proposed by the applicant, and the expected rotation with products from other groups forms an adequate strategy to reduce the risk of development of resistance. On the Dutch label the following sentence is written: Resistentiemanagement Dit middel bevat de werkzame stof flupyradifurone. Flupyradifurone behoort tot de butenoliden. De Irac code is 4D. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.

3.2 Conclusions An authorisation can be granted for all the requested uses, except for lettuce indoor due to an exceedance of the ARfD and the EU MRL of the metabolite DFA. Efficacy against B. tabaci is not proven in ornamentals, flower bulbs and tree nursery crops. Efficacy against A. gossypii in protected ornamentals, flower bulbs and tree nursery crops is not proven.


Sivanto Prime



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


Sivanto Prime



Appendix 1 – Copy of the product authorisation • Evaluator to insert details of the product authorisation for The Netherlands


Sivanto Prime


Applicant: Bayer CropScience Evaluator: Ctgb, NL October 2017

Appendix 2 – Copy of the provisional 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 Gewasbeschermingsmiddelen versie 2.1, Ctgb juni 2015) onder de hierna vermelde toepassingsvoorwaarden. Toepassingsvoorwaarden: Toepassingsgebied Type toepassing Werkzaamheid

getoetst op Dosering* middel per toepassing

Maximale dosering middel per toepassing

Maximaal aantal toepassingen per 12 of 24 maanden

Maximaal aantal liter middel per ha per 12 of 24 maanden

Minimum interval tussen toepassingen in dagen

Veiligheidstermijn in dagen

Hop gewasbehandeling Bladluis 1 0,75 L/ha 0,75 L/ha 1 per 24 maanden

0,75 L/ha per 24 maanden

- 21

Appel

gewasbehandeling - tot volle bloei, of

Bladluis 2, 3, 4, 5

0,04% (40 ml/ 100L)

0,4 L/ha of

1 per 12 maanden


- -

Bladluis 2, 3, 4, 5

Appelbladvlo 6 0,6 L/ha 1

per 24 maanden

gewasbehandeling - vanaf volle bloei

Bladluis 2, 4, 5, 7, 8

Appelbladvlo 6

Appelzaagwesp 9

Toortswants 10

0,06% (60 ml/ 100L)

0,9 L/ha 1 per 24 maanden

14

Peer

gewasbehandeling - tot volle bloei, of

Bladluis 3, 11, 12, 13

Perenbladvlo 14, 15

0,06% (60 ml/ 100L)



- -

gewasbehandeling - vanaf volle bloei

Bladluis 7, 8, 11,13 14

Aardbei gewasbehandeling Wittevlieg 16, 17 0,0625 % 0,625 L/ha 2 1,25 L/ha 10 3


Sivanto Prime



Toepassingsgebied Type toepassing Werkzaamheid getoetst op

Dosering* middel per toepassing






(niet grondgebonden bedekte teelt)

(62,5 ml/100 L)

per 12 maanden per 12 maanden

Bladluis 18, 19, 20, 21

0,05 % (50 ml/100 L)

0,5 L/ha

Aardbei (grondgebonden bedekte teelt)

gewasbehandeling - vanaf begin vorming uitloper

Wittevlieg 16, 17 0,0625 % (62,5 ml/100 L)



- 3

Bladluis 18, 19, 20, 21

0,05 % (50 ml/100 L)

0,5 L/ha

Druif (onbedekte teelt)

gewasbehandeling - vanaf bloeiwijzen volledig ontwikkeld of

Cicaden 22 0,5 L/ha 0,5 L/ha 1 per 12 maanden


- 14

gewasbehandeling - vanaf begin bloei

Druivencicade 23 0,24 L/ha 0,24 L/ha

Framboos (niet grondgebonden bedekte teelt)

gewasbehandeling Bladluis 24, 25

0,1 % (100 ml/100 L)

1 L/ha 2 per 12 maanden

2 L/ha per 12 maanden

10 3

Sla (Lactuca spp.) (onbedekte teelt)

gewasbehandeling - vanaf 2-bladstadium tot kropvorming of ontwikkeling oogstbare gedeelte of

Bladluis 18, 26, 27, 28,

29, 30 0,625 L/ha 0,625 L/ha 1

per 24 maanden 0,625 L/ha per 24 maanden

- 3


Sivanto Prime










gewasbehandeling - vanaf kropvorming of ontwikkeling oogstbare gedeelte

0,625 L/ha (in minimaal 500 L water per ha)

1 per 12 maanden


Courgette (niet grondgebonden bedekte teelt)

gewasbehandeling Wittevlieg 16, 17

Bladluis 25

0,075% (75 ml/ 100L)



10 3

Bladluis 18, 27 0,06% (60 ml/ 100L)

0,9 L/ha

Komkommer (niet grondgebonden bedekte teelt)


Bladluis 25

0,075% (75 ml/ 100L)



10 3

Bladluis 18, 27 0,06% (60 ml/ 100L)

0,9 L/ha

Watermeloen (niet grondgebonden bedekte teelt)


Bladluis 25

0,075% (75 ml/ 100L)



10 3

Bladluis 18, 27 0,06% (60 ml/ 100L)

0,45 L/ha

Vruchtgroenten van Solanaceae (niet grondgebonden bedekte teelt)


Bladluis 25

0,075% (75 ml/100L)



10 3

Bladluis 18, 27 0,06% (60 ml/ 100L)

0,9 L/ha


Sivanto Prime










Tulp (onbedekte teelt)

Gewasbehandeling – vanaf begin bloei

Bladluis 25, 31 0,5 L/ha 0,5 L/ha 1 per 12 maanden


- -

Zantedeschia (onbedekte teelt)




- -

Hyacinth (onbedekte teelt)




- -

Narcis, fijnbollig (onbedekte teelt)




- -

Lelie (onbedekte teelt)




- -

Bloembol-en bloemknolgewassen (niet grondgebonden bedekte teelt)

gewasbehandeling Bladluis 31 0,05% (50 ml/100L)



7 -

Bloembol-en bloemknolgewassen (grondgebonden bedekte teelt)

gewasbehandeling – vanaf begin bloei

Bladluis 31 0,05% (50 ml/100L)



- -

Bloemisterijgewassen (niet grondgebonden onbedekte teelt)

gewasbehandeling Bladluis 18 , 25, 27, 31,

32, 33, 34

0,5 L/ha 0,5 L/ha 4 per 12 maanden


7 -

Bloemisterijgewassen (niet

gewasbehandeling Wittevlieg 16 0,075 % (75 ml/100L)

1,125 L/ha

4 per 12 maanden


7 -


Sivanto Prime










grondbebonden bedekte teelt)

Bladluis 18, 20, 27, 28,

31, 32, 33

0,05% (50 ml/100L)

0,75 L/ha


gewasbehandeling Bladluis 18, 27, 31, 32,

33, 34



7 -

Boomkwekerijgewassen (niet grondgebonden bedekte teelt)


0,75 L/ha

4 per 12 maanden


7 -

Bladluis 18, 20, 27, 31,

32, 33, 34

0,05 % (50 ml/100L)

0,5 L/ha

Vaste plantenteelt (niet grondgebonden onbedekte teelt)

gewasbehandeling Bladluis 18, 25, 27, 31,

32, 33, 34



7 -

Vaste plantenteelt (niet grondgebonden bedekte teelt)


0,75 L/ha

4 per 12 maanden


7 -

Bladluis 18, 20, 27, 28,

31, 32, 33

0,05 % (50 ml/100L)

0,5 L/ha

* 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. Hopluis (Phorodon humuli). 2. Roze appelluis (Dysaphis plantaginea). 3. Appelgrasluis (Rhopalosiphum insertum). 4. Bloedvlekkenluis (Dysaphis devecta). 5. Fluitekruidluis (Dysaphis anthrisci).


Sivanto Prime



6. Appelbladvlo (Psylla mali). 7. Groene appeltakluis (Aphis pomi). 8. Groene citrusluis (Aphis spiraecola). 9. Appelzaagwesp (Hoplocampa testudinea). 10. Toortswants (Campylomma verbasci). 11. Roze perenluis (Dysaphis pyri). 12. Vouwgalluis (Anuraphis farfarae). 13. Zwarte perenluis (Melanaphis pyraria). 14. Perenbladvlo (Psylla pyri). 15. Kleine perenbladvlo (Psylla pyricola). 16. Kaswittevlieg (Trialeurodes vaporariorum). 17. Tabakswittevlieg (Bemisia tabaci). 18. Aardappeltopluis (Macrosiphum euphorbiae). 19. Aardbeiknotshaarluis (Chaetosiphon fragaefolii). 20. Gewone rozenluis (Macrosiphum rosae). 21. Kleine aardbeiluis (Aphis forbesi). 22. Cicaden (Auchenorrhyncha spp.). 23. Druivencicade (Empoasca vitis). 24. Kleine frambozenluis (Aphis idaei). 25. Katoenluis (Aphis gossypii). 26. Groene slaluis (Nasanovia ribisnigri). 27. Groene perzikluis (Myzus persicae). 28. Boterbloemluis (Aulacorthum solani). 29. Bruine slaluis (Uroleucon sonchi). 30. Slaluis (Acyrthosiphon lactucae). 31. Zwarte bonenluis (Aphis Fabae). 32. Sjalottenluis (Myzus ascalonicus). 33. Groene kortstaartluis (Brachycaudus helichrysi). 34. Beukenbladluis (Phyllaphis fagi). Overige toepassingsvoorwaarden Bij mechanische opwaartse veldtoepassing in hop dienen handschoenen en beschermende kleding gedragen te worden. Bij handmatige opwaartse veldtoepassing dienen handschoenen en beschermende kleding gedragen te worden


Sivanto Prime



Om het grondwater te beschermen mag dit product in onbedekte teelten niet worden gebruikt in grondwaterbeschermingsgebieden. Om de vogels te beschermen moet Sivanto Prime in sla (onbedekte teelt) worden toegepast met minimaal 500 L water/ha, indien het wordt toegepast vanaf kropvorming of oogstbare gedeelte (BBCH 41 – 49). De concentratie van de werkzame stof in de spuitvloeistof mag niet meer dan 0,025 kg a.s./hL zijn. Om in het water levende organismen en niet tot de doelsoorten behorende geleedpotigen te beschermen is toepassing uitsluitend toegestaan indien op het gehele perceel gebruik wordt gemaakt van één van de volgende driftreducerende maatregelen: Toepassingsgebied




Hop 0,75 L/ha • Een techniek uit tenminste de klasse DRT99, of: • Een techniek uit tenminste de klasse DRT95 in

combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de insteek van de sloot)

• Een techniek uit tenminste de klasse DRT99, of • Een techniek uit tenminste de klasse DRT95 in

combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens)

Appel


• Een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de insteek van de sloot),



• Een techniek uit tenminste de klasse DRT99, of; • Een tunnelspuit







Sivanto Prime



Toepassingsgebied





• Een techniek uit tenminste de klasse DRT95 • Een techniek uit tenminste de klasse DRT95, of; • Een techniek uit tenminste de klasse DRT75 in

combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens), of:

• Een tunnelspuit, of; • Een windhaag op de rand van het rijpad in combinatie

met éénzijdige bespuiting van de laatste bomenrij in de richting van het perceel

Peer 0,9 L/ha Toepassing vóór 1 mei





• Een techniek uit tenminste de klasse DRT95 • Een techniek uit tenminste de klasse DRT95, of; • Een techniek uit tenminste de klasse DRT75 in

combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens), of:

• Een tunnelspuit, of; • Een windhaag op de rand van het rijpad in

combinatie met éénzijdige bespuiting van de laatste bomenrij in de richting van het perceel


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Toepassingsgebied




Druif 0,5 L/ha • Een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 300 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de insteek van de sloot of de perceelgrens), of;

• Een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de insteek van de sloot of de perceelgrens), of;

• Een tunnelspuit, of; • Een windhaag op de rand van het rijpad in

combinatie met éénzijdige bespuiting van de laatste gewasrij in de richting van het perceel

• Een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 300 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan tot aan de perceelgrens), of;

• Een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 450 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens), of:

• Een tunnelspuit, of; • Een windhaag op de rand van het rijpad in combinatie

met éénzijdige bespuiting van de laatste gewasrij in de richting van het perceel

Bloembol-en bloemknolgewassen (onbedekte teelt)

0,5 L/ha • Geen additionele maatregelen nodig • een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 125 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens)

Bloemisterijgewassen (niet grondgebonden onbedekte teelt)


• in geval van handmatige bespuiting (rugspuit/spuitlans) een afschermkap met inachtneming van een teeltvrije zone van tenminste 300 cm (gemeten vanaf het midden van de laatste




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Toepassingsgebied




gewasrij of de laatste plant in de rij tot aan de insteek van de sloot)


0,5 L/ha • in geval van een neerwaartse bespuiting een techniek uit tenminste de klasse DRT90 in combinatie met een teeltvrije zone van tenminste 175 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de insteek van de sloot of de perceelgrens), of;

• in geval van handmatige neerwaartse bespuiting (rugspuit/spuitlans) een afschermkap met inachtneming van een teeltvrije zone van tenminste 300 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de insteek van de sloot)

• in geval van een zij-/opwaartse bespuiting (laanbomenteelt) een techniek uit tenminste klasse DRT50

• in geval van een neerwaartse bespuiting een techniek uit tenminste de klasse DRT75 in combinatie met een teeltvrije zone van tenminste 175 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens), of;

• in geval van handmatige neerwaartse bespuiting (rugspuit/spuitlans) een afschermkap

• in geval van een zij-/opwaartse bespuiting (laanbomenteelt) een techniek uit tenminste klasse cm DRT50 in combinatie met een totale teelvrije zone van 500 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens). In deze teeltvrije zone mogen gewassen geteeld worden van tenminste dezelfde hoogte als het te bespuiten gewas, waarin geen gewasbeschermingsmiddelen worden gespoten

Vaste plantenteelt (niet grondgebonden, onbedekte teelt)


• in geval van handmatige bespuiting (rugspuit/spuitlans) een afschermkap met inachtneming van een teeltvrije zone van tenminste 300 cm (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de insteek van de sloot)




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Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg deskundigen (uw leverancier van natuurlijke vijanden, de producent van dit middel, uw adviseur over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden. Een toepassing in de teelt van komkommer kan gewasschade tot gevolg hebben. In vruchtgroenten is de gewasveiligheid in de wintermaanden niet onderbouwd, voer een proefbespuiting uit voor het middel op grote schaal toegepast wordt. In bloemisterijgewassen kan enige tijdelijke gewasschade optreden. 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 flupyradifurone. Flupyradifurone behoort tot de butenoliden. De Irac code is 4D. 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.


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Applicant: Bayer CropScience Evaluator: Ctgb, NL October 2017

Appendix 3 – Letter of Access Flupyradifurone is solely owned by Bayer and no access to third party data is required. Moreover, a general Letter of Access has been submitted to Ctgb is which it is stated that all studies and reports belonging to Bayer AG and/or any other Bayer affiliate can be used by any interested affiliate within the Bayer Group, including but not limited to, Bayer CropScience SA-NV. In Section 6 (core assessment) 2 generic field studies from BASF have been referred to. The corresponding letter of access are included in the dossier.


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Appendix 4 – List of data submitted in support of the evaluation A request for additional data protection has been made by the applicant based on the application for minor uses that has been done in the present dossier. A total of 13 minor uses (crops or crop groups have been included. This concerns the following uses (LIJST KLEINE TOEPASSINGEN – based upon the DTG-lijst (versie 2.1, Ctgb 2015): Hop, Aardbei (bedekte teelt), Druif, Framboos (bedekte teelt), Sla, Courgette (bedekte teelt), Komkommer (bedekte teelt), Watermeloen (bedekte teelt), Aubergine (bedekte teelt; op het etiket gezet in de groep van "Vruchtgroenten van Solanaceae"), Bloembol-en bloemknolgewassen (bedekte teelt), Bloemisterijgewassen (niet grondgebonden onbedekte teelt), Vaste planten, Boomkwekerijgewassen (bedekte teelt en niet grondgebonden onbedekte teelt). The additional data protection would be 3 months per minor use with a maximum of 3 years. The period of data protection granted for all studies and reports is therefor 13 years (10 years regular application + 3 years for minor uses). This decision is based upon notitie Ctgb C-310.I.09 “Extra dataprotectie”, d.d. 28-02-2018.

Annex point

Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Data protection

claimed Y/N

Data protection

granted Y/N

Study used Y/N

Owner

KIIIA 2.1 /01

Hennig-Gizewski, S.; Hoppe, M.

2011 Physical, chemical and technical properties of BYI 02960 SL 200 (200 g/L) - BYI 02960 SL 200 G - amendment no.: 1 Bayer CropScience, Report No.: FM0076(PC00)G01, Edition Number: M-402943-02-1 Date: 2011-02-14 ...Amended: 2011-09-19 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.4.2 /01 ...also filed: KIIIA 2.5.1 /01 ...also filed: KIIIA 2.5.2 /01 ...also filed: KIIIA 2.5.3 /01 ...also filed: KIIIA 2.6.1 /01 ...also filed: KIIIA 2.8.2 /01 ...also filed: KIIIA 2.8.4 /01

Yes Y Y Bayer CropScience

KIIIA 2.2.1 /01

Rexer, K.; Schumacher, R.

2011 Safety relevant technical properties of BYI 02960 SL 200 (200 g/L) - Final report - Bayer CropScience, Report No.: FF0091(SA00)G01, Edition Number: M-401926-01-1 Date: 2011-02-14 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.2.2 /01 ...also filed: KIIIA 2.3.1 /01 ...also filed: KIIIA 2.3.3 /01


KIIIA 2.7.1 /01

Hennig-Gizewski, S.; Hoppe, M.

2011 Storage stability and shelf life of BYI 02960 SL 200 (200 g/L) - [Packaging material:HDPE] - Final report (2 years) Bayer CropScience, Report No.: FM0076(SL01)N01, Edition Number: M-402996-02-1 Date: 2011-02-14 ...Amended: 2012-07-25 GLP/GEP: no, unpublished ...also filed: KIIIA 2.7.3 /01 ...also filed: KIIIA 2.7.4 /01 ...also filed: KIIIA 2.7.5 /01

No N Y Bayer CropScience

dart://dart/edition?ed_no=M-402943-02-1




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Annex point


Data protection

claimed Y/N

Data protection

granted Y/N

Study used Y/N

Owner

KIIIA 4.2.2 /01

Friessleben, R. 2008 Summary and conclusive report of studies on spray tank cleaning realized in the years 2000 - 2008 Bayer CropScience, Report No.: M-357166-01-1, Edition Number: M-357166-01-1 GLP/GEP: n.a., unpublished


KIIIA 4.4 /01

Anon. 2014 BYI 02960 SL200 Sample WW BCS AG, Monheim, Germany Bayer CropScience, Report No.: M-423030-05-1, Edition Number: M-423030-05-1 GLP/GEP: n.a., unpublished ...also filed: KIIIA 11.3 /01

No N N Bayer CropScience

KIIIA 4.7 /01

Nuesslein, F. 2012 Flupyradifurone - Incineration as a safe means of disposal and pyrolytic behaviour under controlled conditions Bayer CropScience, Report No.: M-422993-01-1, Edition Number: M-422993-01-1 Date: 2012-01-23 GLP/GEP: no, unpublished


Annex point

Author Year Title Source (where different from

company) Company, Report No.

GLP or GEP status (where relevant) Published or Unpublished

Data protection

claimed Y/N

Data protection

granted Y/N

Study used Y/N

Owner

KIIIA 5.2.1 /01

Zitzmann, W. 2009 Determination of BYI 02960 in formulations ; assay HPLC, external standard Bayer CropScience, Report No.: AM012609MF1, Edition Number: M-343224-01-1 Date: 2009-02-13 GLP/GEP: no, unpublished


KIIIA 5.2.1 /02

Kienow, A. ; Seidel, E.

2010 Validation of HPLC-method AM012609MF1 - Determination of BYI 02960 in formulations - BYI 02960 SL 200 (200 g/L) Bayer CropScience, Report No.: VB2-AM012609MF1, Edition Number: M-395374-01-1 Date: 2010-11-19 GLP/GEP: no, unpublished


KIIIA 5.3.1 /01

Schulte, G.; Teubner, L.

2012 Modification M001 of the analytical method 01330 for the determination of residues of BYI 02960 and its metabolite difluoroacetic acid in/on plant matrix by HPLC-MS/MS- Enforcement method plant Bayer CropScience, Report No.: MR-12/054, Edition Number: M-438310-01-1 Date: 2012-09-10 GLP/GEP: yes, unpublished












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Annex point

Author Year Title Source (where different from

company) Company, Report No.

GLP or GEP status (where relevant) Published or Unpublished

Data protection

claimed Y/N

Data protection

granted Y/N

Study used Y/N

Owner

KIIIA 5.3.1 /02

Konrad, S. 2012 Independent lab validation of BCS method 01330/M001 for the determination of residues of BYI 02960 and its metabolite difluoroacetic acid in/on plant matrices by HPLC-MS/MS Currenta GmbH & Co. OHG, Leverkusen, Germany BCS, Report No.: 01330/M001, Edition Number: M-439855-01-1 Date: 2012-10-15 GLP/GEP: yes, unpublished


Mammalian toxicology

Annex point Year

Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Data protection claimed Y/N

Owner

Data protection granted Y/N

Studies relied on Y/N

KIIIA 7.1.1 /01 2010

BYI 02960 SL 200 g/L - Acute toxicity in the rat after oral administration Report No.: AT05943, Edition Number: M-385422-01-1 Date: 2010-06-17 GLP/GEP: yes, unpublished

Yes Bayer CropScience

Y Y

KIIIA 7.1.2 /01 2010

BYI 02960 SL 200 g/L - Acute toxicity in the rat after dermal application Report No.: AT05944, Edition Number: M-385421-01-1 Date: 2010-06-17 GLP/GEP: yes, unpublished


Y Y

KIIIA 7.1.3 /01 2010

BYI 02960 SL 200 g/L - Acute inhalation toxicity in rats Report No.: AT06016, Edition Number: M-392826-01-1 Date: 2010-10-18 GLP/GEP: yes, unpublished


Y Y

KIIIA 7.1.4 /01 2010

BYI 02960 SL 200 g/L - Acute skin irritation/corrosion on rabbits Report No.: AT05908, Edition Number: M-370381-01-1 Date: 2010-05-06 GLP/GEP: yes, unpublished


Y Y

KIIIA 7.1.5 /01 2010

BYI 02960 SL 200 g/L - Acute eye irritation on rabbits Report No.: AT05812, Edition Number: M-364511-01-1 Date: 2010-02-25 GLP/GEP: yes, unpublished


Y Y

KIIIA 7.1.6 /01 2010

BYI 02960 SL 200 g/L - Evaluation of potential skin sensitization in the local lymph node assay in the mouse Report No.: SA 10101, Edition Number: M-368808-01-1 Date: 2010-05-07 GLP/GEP: yes, unpublished


Y Y

KIIIA 7.6.1 /01 2010

BYI 02960 (SL200) - In vivo dermal absorption study in the male rat Report No.: SA 09255, Edition Number: M-396841-01-1 Date: 2010-11-30 GLP/GEP: yes, unpublished


Y Y










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Annex point Year



Owner

Data protection granted Y/N


KIIIA 7.6.2 /01 2010

BYI 02960 (SL200) - Comparative in vitro dermal absorption study using human and rat skin Report No.: SA 09254, Edition Number: M-391215-01-1 Date: 2010-09-28 GLP/GEP: yes, unpublished


Y Y



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Residues

Annex point Author Year


Data protection

claimed Y/N

Owner

Data protect

ion granted Y/N


KIIIA 8.3.3 /01 Schulte, G.; van Berkum, S.

2013 Determination of the residues of BYI 02960 in/on strawberry after spray application of BYI 02960 SL 200 in the greenhouse in northern France, Germany, Italy and Spain - Flupyradifurone SL 200 (200 g / L) Bayer CropScience, Report No.: 11-2093, Report includes Trial Nos.: 11-2093-01 11-2093-02 11-2093-03 11-2093-04 Edition Number: M-448906-01-1 Date: 2013-03-12 GLP/GEP: yes, unpublished

Yes BCS Y Y

KIIIA 8.3.3 /02 Fargeix, G. 2013 Determination of the residues of BYI 02960 in/on strawberry after spray application of BYI 02960 SL 200 in the greenhouse in the Netherlands, Belgium, southern France and Germany Bayer S.A.S., Bayer CropScience, Lyon, France BCS, Report No.: 12-2121, Report includes Trial Nos.: 12-2121-01 12-2121-02 12-2121-03 12-2121-04 Edition Number: M-456829-01-1 Date: 2013-06-13 GLP/GEP: yes, unpublished

Yes BCS Y Y

KIIIA 8.3.4 /01 Schulte, G.; van Berkum, S.

2013 Determination of the residues of BYI 02960 in/on raspberry after spray application of BYI 02960 SL 200 in the greenhouse in Spain and the Netherlands - Flupyradifurone SL 200 (200 g/L) Bayer CropScience, Report No.: 11-2119, Report includes Trial Nos.: 11-2119-01 11-2119-02 Edition Number: M-448901-01-1 Date: 2013-03-08 GLP/GEP: yes, unpublished

Yes BCS Y Y

KIIIA 8.3.4 /02 Fargeix, G. 2013 Determination of the residues of BYI 02960 in/on raspberry after spray application of BYI 02960 SL 200 in the greenhouse in Spain and the Netherlands Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 12-2122, Report includes Trial Nos.: 12-2122-01 12-2122-02 Edition Number: M-457145-01-1 Date: 2013-06-13 GLP/GEP: yes, unpublished

Yes BCS Y Y






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Annex point Author Year


Data protection

claimed Y/N

Owner

Data protect

ion granted Y/N


KIIIA 8.3.8 /01 Meilland-Berthier, I.

2013 Determination of the residues of BYI 02960 in/on watermelon after spray application of BYI 02960 SL 200 in Spain, Italy and Greece Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 12-2120, Report includes Trial Nos.: 12-2120-01 12-2120-02 12-2120-03 12-2120-04 Edition Number: M-468897-01-1 Date: 2013-10-18 GLP/GEP: yes, unpublished

Yes BCS Y Y

Fate Central Zone core assessment Annex point



Owner Study relied on

Data protection granted

KIIIA 9.4 /01

Scherr, F.; Ellerich, C.

2013 Flupyradifurone (FPF) and metabolites: PECsoil EUR - Use in apples, pears, tree nursery, grapes, hops and tobacco in Europe Bayer CropScience, Report No.: EnSa-13-0619, Edition Number: M-472045-01-1 Date: 2013-11-29 GLP/GEP: no, unpublished ...also filed: KIIIA 9.5 /01

No Bayer CropScience

Yes No

KIIIA 9.4 /02

Sur, R.; Ellerich, C.

2013 FPF PECsoil FOCUS EUR: Predicted environmental concentrations in soil (PECsoil) of flupyradifurone and its metabolites- Use in hops and lettuce in m461359011Europe Bayer CropScience, Report No.: EnSa-13-0432, Edition Number: M-461359-01-1 Date: 2013-07-09 GLP/GEP: no, unpublished ...also filed: KIIIA 9.5 /02


Yes No

KIIIA 9.4 /03


2013 Flupyradifurone (FPF) and metabolites: PECsoil EUR - Use in different vegetables and flower bulbs in Europe Bayer CropScience, Report No.: EnSa-13-0705, Edition Number: M-471208-01-1 Date: 2013-10-17 GLP/GEP: no, unpublished ...also filed: KIIIA 9.5 /03


Yes No

KIIIA 9.4 / 04

Sur, R.; Gabsi, F.

2016 Flupyradifurone (FPF) and metabolites: PECsoil EUR - Use in flower bulbs in Europe Bayer Report No.: EnSa-16-0575 Edition Number: M-573409-01-1 Date: 2016-07-06 GLP/GEP: No, unpublished ... also filed:

KIIIA 9.5 / 04

No Bayer Yes No







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Annex point





KIIIA 9.4 / 05

van Noorloos, B.; Jansen, M.

2011 Interception flower bulbs Bayer CropScience B.V., Mijdrecht, Netherlands Bayer Report No.: BN20110017 Edition Number: M-417654-01-2 Date: 2011-11-21 GLP/GEP: n.a., unpublished

No Bayer Yes No

KIIIA 9.5 /01


2013 Flupyradifurone (FPF) and metabolites: PECsoil EUR - Use in apples, pears, tree nursery, grapes, hops and tobacco in Europe Bayer CropScience, Report No.: EnSa-13-0619, Edition Number: M-472045-01-1 Date: 2013-11-29 GLP/GEP: no, unpublished ...also filed: KIIIA 9.4 /01


Yes No

KIIIA 9.5 /02

Sur, R.; Ellerich, C.

2013 FPF PECsoil FOCUS EUR: Predicted environmental concentrations in soil (PECsoil) of flupyradifurone and its metabolites- Use in hops and lettuce in Europe Bayer CropScience, Report No.: EnSa-13-0432, Edition Number: M-461359-01-1 Date: 2013-07-09 GLP/GEP: no, unpublished ...also filed: KIIIA 9.4 /02


Yes No

KIIIA 9.5 /03


2013 Flupyradifurone (FPF) and metabolites: PECsoil EUR - Use in different vegetables and flower bulbs in Europe Bayer CropScience, Report No.: EnSa-13-0705, Edition Number: M-471208-01-1 Date: 2013-10-17 GLP/GEP: no, unpublished

...also filed: KIIIA 9.4 /03


Yes No

KIIIA 9.5 / 04

Sur, R.; Gabsi, F.

2016 Flupyradifurone (FPF) and metabolites: PECsoil EUR - Use in flower bulbs in Europe Bayer Report No.: EnSa-16-0575 Edition Number: M-573409-01-1 Date: 2016-07-06 GLP/GEP: No, unpublished ... also filed:

KIIIA 9.4 / 04

No Bayer Yes No

KIIIA 9.6 / 02

Scherr, F. 2014 Evaluation of the kinetic sorption parameters for flupyradifurone and their dependence on starting values - Flupyradifurone (BYI 02960) Bayer Report No.: EnSa-14-0804 Edition Number: M-491714-03-1 Date: 2014-07-10 ... amended: 2014-11-07 GLP/GEP: No, unpublished

No Bayer Yes No








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Annex point





KIIIA 9.6.1 /08

Kley, C.; Lange, N.

2015 Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in apples, vines, and tobacco in Europe Bayer CropScience, Report No.: EnSa-15-0339, Edition Number: M-525260-01-1 Date: 2015-06-18 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /08


Yes No

KIIIA 9.6.1 /09

Kley, C.; Hoerold, C.

2015 Tier 2a (TDS) - Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in apples, vines and tobacco in Europe - Flupyradifurone (BYI 02960) - Difluoroacetic acid (BCS-AA56716) - 6-Chloronicotinic Acid (BNF 5119B) Bayer CropScience, Report No.: EnSa-15-0308, Edition Number: M-526213-01-1 Date: 2015-06-18 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /09


Yes No

KIIIA 9.6.1 /10

Kley, C.; Lange, N.

2015 Tier 1 (SFO) - Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in tomatoes and flowerbulbs (onions / winter cereals as surrogate) in Europe Bayer CropScience, Report No.: EnSa-15-0348, Edition Number: M-525266-01-1 Date: 2015-05-04 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /10


Yes No

KIIIA 9.6.1 / 11


2017 Tier 2a (TDS) - Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in tomatoes and flowerbulbs (onions / winter cereals as surrogate) in Europe Bayer Report No.: EnSa-15-0341 Edition Number: M-526216-02-1 Date: 2015-04-17 ... amended: 2017-01-27 GLP/GEP: No, unpublished ... also filed:

KIIIA 9.6.2 / 11

No Bayer Yes No






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Annex point





KIIIA 9.6.1 /12

Kley, C.; Lange, N.

2015 Tier 1 (SFO) - Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in lettuce in Europe Bayer CropScience, Report No.: EnSa-15-0355, Edition Number: M-525267-01-1 Date: 2015-06-18 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /12


Yes No

KIIIA 9.6.1 /13


2015 Tier 2a (TDS) - Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in lettuce (cabbage) in Europe Bayer CropScience, Report No.: EnSa-15-0318, Edition Number: M-526228-01-1 Date: 2015-06-19 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /13


Yes No

KIIIA 9.6.1 / 14

Sur, R; Gabsi, F

2016 Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR(Tier 2a TDS) - Use in apples and vines in Europe Bayer Report No.: EnSa-16-0560 Edition Number: M-573448-01-1 Date: 2016-07-14 GLP/GEP: No, unpublished ... also filed:

KIIIA 9.6.2 / 14

No Bayer Yes No





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Annex point





KIIIA 9.6.2 /08

Kley, C.; Lange, N.

2015 Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in apples, vines, and tobacco in Europe Bayer CropScience, Report No.: EnSa-15-0339, Edition Number: M-525260-01-1 Date: 2015-06-18 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /08


Yes No

KIIIA 9.6.2 /09


2015 Tier 2a (TDS) - Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in apples, vines and tobacco in Europe - Flupyradifurone (BYI 02960) - Difluoroacetic acid (BCS-AA56716) - 6-Chloronicotinic Acid (BNF 5119B) Bayer CropScience, Report No.: EnSa-15-0308, Edition Number: M-526213-01-1 Date: 2015-06-18 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /09


Yes No

KIIIA 9.6.2 /10

Kley, C.; Lange, N.

2015 Tier 1 (SFO) - Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in tomatoes and flowerbulbs (onions / winter cereals as surrogate) in Europe Bayer CropScience, Report No.: EnSa-15-0348, Edition Number: M-525266-01-1 Date: 2015-05-04 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /10


Yes No

KIIIA 9.6.2 / 11


2017 Tier 2a (TDS) - Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in tomatoes and flowerbulbs (onions / winter cereals as surrogate) in Europe Bayer Report No.: EnSa-15-0341 Edition Number: M-526216-02-1 Date: 2015-04-17 ... amended: 2017-01-27 GLP/GEP: No, unpublished ... also filed:

KIIIA 9.6.1 / 11

No Bayer Yes No






Sivanto Prime



Annex point





KIIIA 9.6.2 /12

Kley, C.; Lange, N.

2015 Tier 1 (SFO) - Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in lettuce in Europe Bayer CropScience, Report No.: EnSa-15-0355, Edition Number: M-525267-01-1 Date: 2015-06-18 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /12


Yes No

KIIIA 9.6.2 /13


2015 Tier 2a (TDS) - Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in lettuce (cabbage) in Europe Bayer CropScience, Report No.: EnSa-15-0318, Edition Number: M-526228-01-1 Date: 2015-06-19 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /13


Yes No

KIIIA 9.6.2 / 14

Sur, R; Gabsi, F

2016 Flupyradifurone (FPF) and metabolites: PECgw FOCUS PEARL, PELMO EUR(Tier 2a TDS) - Use in apples and vines in Europe Bayer Report No.: EnSa-16-0560 Edition Number: M-573448-01-1 Date: 2016-07-14 GLP/GEP: No, unpublished ... also filed:

KIIIA 9.6.1 / 14

No Bayer Yes No





Sivanto Prime



Annex point





KIIIA 9.7 /01


2013 Flupyradifurone (FPF) and metabolites: PECsw,sed FOCUS EUR - Use in apples in Europe Bayer CropScience, Report No.: EnSa-13-0554, Edition Number: M-471196-01-1 Date: 2013-09-25 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /01


Yes No

KIIIA 9.7 /02


2013 Flupyradifurone (FPF) and metabolites: PECsw,sed FOCUS EUR - Use in grapes, hops and tobacco in Europe Bayer CropScience, Report No.: EnSa-13-0556, Edition Number: M-472037-01-1 Date: 2013-11-28 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /02


Yes No

KIIIA 9.7 /03


2013 Flupyradifurone (FPF) and metabolites: PECsw,sed FOCUS EUR - Use in fruiting vegetables and flower bulbs in Europe Bayer CropScience, Report No.: EnSa-13-0704, Edition Number: M-472048-01-1 Date: 2013-12-02 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /03


Yes No

KIIIA 9.7 /04


2013 Flupyradifurone (FPF) and metabolites: PECsw,sed FOCUS EUR - Use in lettuce and hops in Europe Bayer CropScience, Report No.: EnSa-13-0431, Edition Number: M-461364-02-1 Date: 2013-07-22 ...Amended: 2013-10-25 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /04


Yes No

KIIIA 9.7 / 05

Scherr, F. 2016 Flupyradifurone (FPF): PECsw FOCUS Step4 VFSMOD EUR - Use in pome fruits, flowerbulbs, lettuce, fruiting vegetables hops and tobacco in Europe Report No.: EnSa-13-0934 Edition Number: M-473073-02-1 Date: 2013-12-02 ... amended: 2016-12-12 GLP/GEP: No, unpublished

No Bayer Yes No

KIIIA 9.7 / 06

Sur, R.; Gabsi, F.

2016 Flupyradifurone (FPF) and metabolites: PECsw,sed FOCUS EUR (steps12) - Use in tree nursery and ornamentals (container crops) in Europe Bayer Report No.: EnSa-16-0850 Edition Number: M-573390-01-1 Date: 2016-11-10 GLP/GEP: No, unpublished

No Bayer Yes No

KIIIA 9.7 / 07

Sur, R.; Gabsi, F.

2016 Flupyradifurone (FPF): PECsw,sed FOCUS EUR (steps 3/4) - Use in tree nursery and ornamentals (container crops) in Europe Bayer Report No.: EnSa-16-0869 Edition Number: M-573397-01-1 Date: 2016-10-24 GLP/GEP: No, unpublished

No Bayer Yes No









Sivanto Prime



Annex point





KIIIA 9.8 /01


2013 Flupyradifurone (FPF) and metabolites: PECsw,sed FOCUS EUR - Use in apples in Europe Bayer CropScience, Report No.: EnSa-13-0554, Edition Number: M-471196-01-1 Date: 2013-09-25 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /01


Yes No

KIIIA 9.8 /02


2013 Flupyradifurone (FPF) and metabolites: PECsw,sed FOCUS EUR - Use in grapes, hops and tobacco in Europe Bayer CropScience, Report No.: EnSa-13-0556, Edition Number: M-472037-01-1 Date: 2013-11-28 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /02


Yes No

KIIIA 9.8 /03


2013 Flupyradifurone (FPF) and metabolites: PECsw,sed FOCUS EUR - Use in fruiting vegetables and flower bulbs in Europe Bayer CropScience, Report No.: EnSa-13-0704, Edition Number: M-472048-01-1 Date: 2013-12-02 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /03


Yes No

KIIIA 9.8 /04


2013 Flupyradifurone (FPF) and metabolites: PECsw,sed FOCUS EUR - Use in lettuce and hops in Europe Bayer CropScience, Report No.: EnSa-13-0431, Edition Number: M-461364-02-1 Date: 2013-07-22 ...Amended: 2013-10-25 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /04


Yes No

KIIIA 9.8 / 05

Sur, R.; Gabsi, F.

2016 Flupyradifurone (FPF) and metabolites:PECsw,sed FOCUS EUR(addendum to EnSa-13-0554) - Use in apples in Europe Bayer Report No.: EnSa-16-0576 Edition Number: M-573405-01-1 Date: 2016-07-14 GLP/GEP: No, unpublished

No Bayer Yes No

KIIIA 9.8 / 06

Sur, R.; Gabsi, F.

2016 Flupyradifurone (FPF) and metabolites:PECsw,sed FOCUS EUR(addendum to EnSa-13-0431) - Use in lettuce in Europe Bayer Report No.: EnSa-16-0928 Edition Number: M-573401-01-1 Date: 2016-11-25 GLP/GEP: No, unpublished

No Bayer Yes No

Interzonal core assessment








Sivanto Prime



Annex point





KIIIA 9.4 /01


2014 Flupyradifurone (FPF) and metabolites: PECsoil EUR - Use in greenhouses on different crops in Europe Bayer CropScience, Report No.: EnSa-14-0436, Edition Number: M-486028-01-1 Date: 2014-04-17 GLP/GEP: no, unpublished


Yes No

KIIIA 9.4 / 02

Sur, R.; Gabsi, F.

2016 Flupyradifurone (FPF) and metabolites: PECsoil EUR - Use in greenhouses on different crops in Europe Bayer Report No.: EnSa-16-0566 Edition Number: M-573430-01-1 Date: 2016-06-29 GLP/GEP: No, unpublished

No Bayer Yes No

National Addendum Annex point





KIIIA 9.6.1 /03


2015 Tier 2a (TDS) - Flupyradifurone (FPF) and metabolites: PECgw GeoPEARL - Use in flower bulbs in NLD Bayer CropScience, Report No.: EnSa-15-0319, Edition Number: M-526230-01-1 Date: 2015-04-17 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /03


Yes No

KIIIA 9.6.1 / 05

Sur, R.; Gabsi, F.

2016 Tier 2a (TDS) - Flupyradifurone (FPF) and metabolites: PECgw GeoPEARL - Use in flower bulbs in NLD Bayer Report No.: EnSa-16-0572 Edition Number: M-573444-01-1 Date: 2016-07-07 GLP/GEP: No, unpublished ... also filed:

KIIIA 9.6.2 / 04

No Bayer CropScienc

e

Yes No






Sivanto Prime



Annex point





KIIIA 9.6.2 /03


2015 Tier 2a (TDS) - Flupyradifurone (FPF) and metabolites: PECgw GeoPEARL - Use in flower bulbs in NLD Bayer CropScience, Report No.: EnSa-15-0319, Edition Number: M-526230-01-1 Date: 2015-04-17 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /03


Yes No

KIIIA 9.6.2 /04

Sur, R.; Gabsi, F.

2016 Tier 2a (TDS) - Flupyradifurone (FPF) and metabolites: PECgw GeoPEARL - Use in flower bulbs in NLD Bayer Report No.: EnSa-16-0572 Edition Number: M-573444-01-1 Date: 2016-07-07 GLP/GEP: No, unpublished ... also filed: KIIIA 9.6.1 / 05


Yes No

KIIIA 9.7 /01

Scherr, F.

2013 Flupyradifurone (FPF) and metabolites: PECsw,sed TOXSWA NL - Use in pome fruits, grapes, lettuce, hops, flowerbulbs, ornamentals and tree nursery in the Netherlands Bayer CropScience, Report No.: EnSa-13-0890, Edition Number: M-472052-01-1 Date: 2013-11-08 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /01


Yes No

KIIIA 9.7 /03


2013 Predicted environmental concentrations in surface water (PECsw) for flupyradifurone calculated with TOXSWA 1.2 - Greenhouse uses in the Netherlands Bayer CropScience, Report No.: EnSa-13-0939, Edition Number: M-472305-01-1 Date: 2013-12-02 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /02


Yes No

KIIIA 9.8 /01

Scherr, F.

2013 Flupyradifurone (FPF) and metabolites: PECsw,sed TOXSWA NL - Use in pome fruits, grapes, lettuce, hops, flowerbulbs, ornamentals and tree nursery in the Netherlands Bayer CropScience, Report No.: EnSa-13-0890, Edition Number: M-472052-01-1 Date: 2013-11-08 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /01


Yes No

KIIIA 9.8 /02


2013 Predicted environmental concentrations in surface water (PECsw) for flupyradifurone calculated with TOXSWA 1.2 - Greenhouse uses in the Netherlands Bayer CropScience, Report No.: EnSa-13-0939, Edition Number: M-472305-01-1 Date: 2013-12-02 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /03


Yes No








Sivanto Prime



Annex point





KIIIA 9.8.7 /01

Scherr, F.

2013 Flupyradifurone (FPF): PECsw2dw TOXSWA NL - Use in pome fruits, grapes, lettuce, hops, flowerbulbs, ornamentals and tree nursery in the Netherlands - Flupyradifurone (BYI 02960) Bayer CropScience, Report No.: EnSa-13-0933, Edition Number: M-472331-01-1 Date: 2013-12-02 GLP/GEP: no, unpublished


Yes No

Ecotoxicology Field core Annex point



Owner Data protection granted Y/N

Study relied on Y/N

KIIIA 10.1.6 /01

2012 Toxicity of BYI 02960 sl 200 during an acute oral LD50 with the Northern bobwhite quail (Colinus virginianus) Bayer CropScience, Report No.: EBRVP093, Edition Number: M-424312-01-1 EPA MRID No.: 48844512 Date: 2012-02-03 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.1.6 /02

2012 Acute oral toxicity of chicken (Gallus gallus domesticus) with BYI 02960 SL 200, according to OECD 223 - limit test- Report No.: BAR/LD 142, Edition Number: M-423043-01-1 Date: 2012-01-06 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.2.2.1 /01

2010 Acute toxicity of BYI 02960 SL 200 G to fish (Oncorhynchus mykiss) under static conditions-limit test Bayer CropScience, Report No.: EBRVP098, Edition Number: M-398721-02-1 Date: 2010-12-20 ...Amended: 2012-01-19 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.2.2.1 /02

2011 Acute toxicity of BYI 02960 SL 200 G to fish (Cyprinus carpio) under static conditions (limit test) Bayer CropScience, Report No.: EBRVP199, Edition Number: M-420485-01-1 Date: 2011-12-19 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.2.2.2 /01

Riebschlaeger, T.

2010 Acute toxicity of BYI 02960 SL 200 G to the waterflea Daphnia magna in a static laboratory test system Bayer CropScience, Report No.: EBRVP097, Edition Number: M-393738-01-1 Date: 2010-10-28 GLP/GEP: yes, unpublished


Y Y








Sivanto Prime



Annex point




Study relied on Y/N

KIIIA 10.2.2.3 /01

Bruns, E. 2010 Pseudokirchneriella subcapitata growth inhibition test with BYI 02960 SL 200 G Bayer CropScience, Report No.: EBRVP095, Edition Number: M-397244-01-1 Date: 2010-12-20 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.2.6.2 /01

Silke, G. 2011 Chironomus riparius 28-day chronic toxicity test with BYI 02960 SL 200 G in a water-sediment system using spiked water Bayer CropScience, Report No.: EBRVP182, Edition Number: M-416145-01-1 Date: 2011-10-17 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.3 /01

Ebeling, M.

2015 Response of Bayer CropScience to the data gap - Further information is required to address the long-term risk to small herbivorous mammals from dietary routes in lettuce (relevant for the representative field uses on lettuce; submission date proposed by the applicant: unknown; see Section 5 - Listed under point 7.1: Conclusion on the peer review of the pesticide risk assessment of the active substance flupyradifurone presented by the European Food Safety Authority under document number EFSA Journal 2015;13(2):4020 Bayer CropScience, Report No.: M-511393-01-1, Edition Number: M-511393-01-1 Date: 2015-02-26 GLP/GEP: n.a., unpublished


N N

KIIIA 10.3 /02

Brauer, M.; Wang, M.

2015 Benchmark dose calculation for flupyradifurone for several rat toxicity studies combined Report No.: M-511219-01-1, Edition Number: M-511219-01-1 GLP/GEP: n.a., published


N Y

KIIIA 10.3.3 /01

Jacob, J.; Manson, P.; Barfknecht, R.; Fredricks, T.

2013 Common vole (Microtus arvalis) ecology and management: implications for risk assessment of plant protection products Publisher:(wileyonlinelibrary.com) DOI 10.1002/ps.3695, Journal:Society of Chemical Industry, Pest Manag Sci, Year:2014, Report No.: M-476622-01-1, Edition Number: M-476622-01-1 GLP/GEP: n.a., published

No Public N N

KIIIA 10.3.3 /02

Barfknecht, R.

2013 Voles in fields with leafy vegetables Bayer CropScience, Report No.: BAR/FS065, Edition Number: M-449690-01-1 Date: 2013-03-15 GLP/GEP: yes, unpublished


N N

KIIIA 10.3.3 /03

2006 Small mammal monitoring in pome orchards of Baden-Wuerttemberg and Thuringia BASF, Report No.: RC05-021, Edition Number: M-291201-01-1 Date: 2006-12-30 GLP/GEP: no, unpublished

No BASF N N












Sivanto Prime



Annex point




Study relied on Y/N

KIIIA 10.3.3 /04

Oldeweme, J.; Kuenast, C.

2007 Letter of access for generic behavioural ecology data - Study report BASF DocID 2006/1039467 - Grouping: Pome-fruit orchard, foliar stages BASF AG, Limburgerhof, Germany Bayer CropScience, Report No.: M-306283-01-1, Edition Number: M-306283-01-1 Date: 2007-09-14 GLP/GEP: n.a., unpublished


N N

KIIIA 10.3.3 /05

2009 Field study on small herbivorous mammals in modern pome fruit orchards - Evaluation in support of regulatory submissions BASF, Report No.: 2009/1100344, Edition Number: M-355596-01-1 Date: 2009-09-14 GLP/GEP: n.a., unpublished

No BASF N N

KIIIA 10.3.3 /06

Oldeweme, J. Kuenast, C.

2009 Letter of Access for Generic Behavioural Ecology Data: Study Report BASF DocID 2006/1039467 and Evaluation Document BASF DocID 2009/1100344 - Grouping: Pome-fruit orchard, foliar stages: - Small mammal monitoring in modern pome fruit orchards of Baden-Wuerttemberg and Thuringia - and - Field study on small herbivorous mammals in modern pome fruit orchards: Evaluation in support of regulatory submissions- BASF AG, Limburgerhof, Germany Bayer CropScience, Report No.: M-355944-01-1, Edition Number: M-355944-01-1 Date: 2009-09-15 GLP/GEP: n.a., unpublished


N N

KIIIA 10.3.3 /07

Lauenstein, G.

1979 Zur Problematik der Bekaempfung von Feldmaeusen (Microtus arvalis (Pall.)) auf Gruenland Journal:Zeitschrift fuer Angewandte Zoologie, Volume:66, Pages:35 - 59, Year:1979, Report No.: M-419441-01-1, Edition Number: M-419441-01-1 GLP/GEP: n.a., published

No Public literature

N N

KIIIA 10.3.3 /08

Wang, M. 2014 Population modeling · Use of scenarios to avoid different levels of protection Journal:WSC Regexperts, Year:2014, Report No.: M-489393-01-1, Edition Number: M-489393-01-1 GLP/GEP: n.a., published

No Public literature

N N

KIIIA 10.4.2.1 /01

Schmitzer, S.

2009 Revised final report no.: 1 - Effects of BYI 02960 SL 200 G (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 52331035, Edition Number: M-359920-02-1 Date: 2009-12-03 ...Amended: 2012-03-22 GLP/GEP: yes, unpublished


Y Y












Sivanto Prime



Annex point




Study relied on Y/N

KIIIA 10.4.2.2 /01

Vergé, E. 2012 Flupyradifurone SL 200 G: Acute contact toxicity to the bumblebee Bombus terrestris L.(Hymenoptera, Apidae) under laboratory conditions (multi doses test) Eurofins-GAB GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S12-03216, Edition Number: M-443696-01-1 Date: 2012-12-13 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.4.3 /01

Porch, J. R.; Krueger, H. O.

2011 BYI 02960 200 SL: A foliage residue toxicity study with the honeybee Wildlife International, Ltd., Easton, MD, USA Bayer CropScience, Report No.: EBRVP044, Report includes Trial Nos.: 149-220 Edition Number: M-413084-01-1 EPA MRID No.: 48843728 Date: 2011-07-13 GLP/GEP: yes, unpublished


Y N

KIIIA 10.4.5 /01

Rexer, H. U.

2012 Assessment of side effects on the honeybee (Apis mellifera L.), exposed to winter oil-seed rape, grown from seeds treated with BYI 02960 FS 480 G and sequentially sprayed with BYI 02960 SL 200 G during immediate pre- and full flowering in a long-term field study in Northern Germany Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-03261, Report includes Trial Nos.: 2012-09-27 S10-03261-L2 S10-03261-L3 Edition Number: M-438818-01-1 Date: 2012-09-27 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.4.5 /02

Rexer, H. U.

2012 Assessment of side effects on the honeybee (Apis mellifera L.), exposed to winter oil-seed rape, grown from seeds treated with BYI 02960 FS 480 G and sequentially sprayed with BYI 02960 SL 200 G during immediate pre- and full flowering in a long-term field study in France Eurofins Agroscience Services GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-03262, Report includes Trial Nos.: S10-03262-01 S10-03262-02 Edition Number: M-438819-01-1 Date: 2012-07-24 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.4.7 /01

Schnorbach, H. J.

2012 Evaluation of the effects of BYI 02960 SL 100 on honey bees (Apis mellifera) in a semifield tunnel test in full-flowering Phacelia tanacetifolia Bayer CropScience, Report No.: IA08DVG048G001, Edition Number: M-427040-01-1 Date: 2012-03-15 GLP/GEP: no, unpublished


N Y







Sivanto Prime



Annex point




Study relied on Y/N

KIIIA 10.4.7 /02

Schnorbach, H. J.

2012 Evaluation of the effects of BYI 02960 SL 200 on honey bees (Apis mellifera) in a semifield tunnel test in full-flowering Phacelia tanacetifolia Bayer CropScience, Report No.: IA09DVG051K619, Edition Number: M-427046-01-1 Date: 2012-03-15 GLP/GEP: no, unpublished


N Y

KIIIA 10.4.7 /03

Rentschler, S.

2012 BYI 02960 SL 200 G: A semi-field study in Germany 2009 to evaluate effects of spray applications in Phacelia tanacetifolia on the honeybee Apis mellifera L. (Hymenoptera, Apidea) Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S09-00854, Report includes Trial Nos.: S09-00854-01_BZEU Edition Number: M-425576-01-1 Date: 2012-02-17 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.4.7 /04

Proebsting, A.

2012 BYI 02960 SL 200 G: A semi-field study in Denmark 2010 to evaluate effects of spray applications in Phacelia tanacetifolia on the honeybee Apis mellifera L. (Hymenoptera, Apidae) Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-01954, Report includes Trial Nos.: S10-01954-01_BZEU Edition Number: M-423156-01-1 Date: 2012-01-19 GLP/GEP: yes, unpublished


Y N

KIIIA 10.4.7 /05

Proebsting, A.

2012 BYI 02960 SL 200 G: A semi-field study in Italy 2011 to evaluate effects of spray applications in Phacelia tanacetifolia on the honeybee Apis mellifera L. (Hymenoptera, Apidae) Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-01955, Report includes Trial Nos.: S10-01955-01-BZEU Edition Number: M-423172-01-1 Date: 2012-01-18 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.4.7 /06

Rentschler, S.

2012 Determination of side-effects of BYI 02960 SL 200 G on honey bee (Apis mellifera L.) brood under semi-field conditions Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-03819, Report includes Trial Nos.: S10-03819-01 Edition Number: M-427438-01-1 Date: 2012-03-19 GLP/GEP: yes, unpublished


Y Y







Sivanto Prime



Annex point




Study relied on Y/N

KIIIA 10.5.1 /01

Jans, D. 2010 Toxicity to the parasitoid wasp Aphidius rhopalosiphi (DESTEPHANI-PEREZ) (Hymenoptera: Braconidae) using a laboratory test; BYI 02960 SL 200 g/L Bayer CropScience, Report No.: CW09/079, Edition Number: M-366965-01-1 Date: 2010-04-15 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.5.1 /02

Jans, D. 2010 Toxicity to the predatory mite Typhlodromus pyri SCHEUTEN (Acari, Phytoseiidae) using a laboratory test; BYI 02960 SL 200 g/L Bayer CropScience, Report No.: CW09/073, Edition Number: M-366957-01-1 Date: 2010-04-15 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.5.2 /01

Jans, D. 2010 Toxicity to the parasitoid wasp Aphidius rhopalosiphi (DESTEPHANI-PEREZ) (Hymenoptera: Braconidae) using an extended laboratory test on barley BYI 02960 SL 200 (g/L) Bayer CropScience, Report No.: CW09/083, Edition Number: M-366970-01-1 Date: 2010-04-13 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.5.2 /02

Jans, D. 2010 Toxicity to the predatory mite Typhlodromus pyri SCHEUTEN (Acari, Phytoseiidae) using an extended laboratory test on Phaseolus vulgaris BYI 02960 SL 200 (g/L) Bayer CropScience, Report No.: CW09/076, Edition Number: M-366968-01-1 Date: 2010-04-13 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.5.2 /03

Jans, D. 2010 Toxicity to the ladybird beetle Coccinella septempunctata L. (Coleoptera, Coccinellidae) using an extended laboratory test on Phaseolus vulgaris; BYI 02960 SL 200 (g/L) Bayer CropScience, Report No.: CW09/074, Edition Number: M-384754-01-1 Date: 2010-06-30 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.5.2 /04

Jans, D. 2010 Chronic toxicity (ER50) of BYI 02960 SL 200 (g/L) to the rove beetle Aleochara bilineata Gyll. (Coleoptera: Staphylinidae) under extended laboratory conditions Bayer CropScience, Report No.: CW09/072, Edition Number: M-384433-01-1 Date: 2010-06-30 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.5.3 /01

Jans, D. 2010 Toxicity to the parasitoid wasp Aphidius rhopalosiphi (DESTEPHANI-PEREZ) (Hymenoptera: Braconidae) in an extended laboratory test (under semi-field conditions aged residues on Zea mays) BYI 02960 SL 200 (g/L) Bayer CropScience, Report No.: CW10/018, Edition Number: M-396372-01-1 Date: 2010-11-30 GLP/GEP: yes, unpublished


Y Y









Sivanto Prime



Annex point




Study relied on Y/N

KIIIA 10.5.3 /02

Schwarz, A.

2010 Effects of BYI 02960 SL 200 (g/L) on the predatory bug Orius laevigatus extended laboratory study - aged residue test IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 58691053, Edition Number: M-394033-01-1 Date: 2010-10-28 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.5.4 /01

Aldershof, S.; Bakker, F.

2012 A field study to assess the effects of BYI 02960 SL 200 g/L on the non-target, surface- and plantdwelling, arthropod fauna of a grassland habitat (off-crop) in The Netherlands during summer MITOX Consultants, Amsterdam, Netherlands Bayer CropScience, Report No.: B154FFN, Edition Number: M-425092-01-1 Date: 2012-02-17 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.5.4 /02

Aldershof, S.; Bakker, F.

2012 A field study to assess the effects of BYI 02960 (SL 200 g/L) on the non-target, surface- and plant-dwelling arthropod fauna of a grassland habitat (off-crop) in SW France during summer MITOX Consultants, Amsterdam, Netherlands Bayer CropScience, Report No.: B153FFN, Edition Number: M-425080-01-1 Date: 2012-02-17 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.6.2 /01

Leicher, T. 2010 BYI 02960 SL 200 G: acute toxicity to earthworms (Eisenia fetida) tested in artificial soil with 5 percent peat Bayer CropScience, Report No.: LRT/RG-A-143/10, Edition Number: M-397720-01-1 Date: 2010-12-14 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.6.3 /01

Leicher, T. 2010 BYI 02960 SL 200 G: Effects on survival, growth and reproduction on the earthworm Eisenia fetida tested in artificial soil Bayer CropScience, Report No.: LRT-RG-R-76/09, Edition Number: M-392964-01-2 Date: 2010-10-21 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.6.4 /01

Menke, U. 2012 BYI 02960 SL 200 G: Effects on the earthworm fauna of a grassland area within one year Bayer CropScience, Report No.: MNU/RG-F-8/12, Edition Number: M-426607-01-1 Date: 2012-03-07 GLP/GEP: yes, unpublished


Y N

KIIIA 10.6.6 /01

Frommholz, U.

2009 BYI 02960 SL 200 G: Influence on the reproduction of the collembola species Folsomia candida tested in artificial soil with 5 % peat Bayer CropScience, Report No.: FRM-COLL-75/09, Edition Number: M-359728-01-1 Date: 2009-12-02 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.6.6 /02

Kratz, M.-A.

2009 BYI 02960 SL 200 G: Influence on mortality and reproduction on the soil mite species Hypoaspis aculeifer tested in artificial soil with 5 % peat Bayer CropScience, Report No.: KRA-HR-19/09, Edition Number: M-358752-01-1 Date: 2009-11-10 GLP/GEP: yes, unpublished


Y Y










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Annex point




Study relied on Y/N

KIIIA 10.6.7 /01

Leicher, T. 2011 BYI 02960: Effects on soil litter degradation after spray application Bayer CropScience, Report No.: LRT-SLD-45/11, Edition Number: M-413408-01-1 Date: 2011-09-06 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.6.7 /02

Leicher, T. 2011 BYI 02960: Effects on soil litter degradation if applied as seed treatment Bayer CropScience, Report No.: LRT-SLD-46/11, Edition Number: M-413416-01-1 Date: 2011-09-06 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.7.1 /01

Frommholz, U.

2010 BYI 02960 SL 200 G : Determination of effects on carbon transformation in soil Bayer CropScience, Report No.: FRM-C-116/10, Edition Number: M-395469-01-1 Date: 2010-11-23 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.7.1 /02

Frommholz, U.

2010 BYI 02960 SL 200 G: Determination of effects on nitrogen transformation in soil Bayer CropScience, Report No.: FRM-N-148/10, Edition Number: M-396112-01-1 Date: 2010-11-29 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.8.1.2 /01

Gosch, H. 2010 BYI 02960 SL 200 g/L - Effects on the vegetative vigour of eleven species of non-target terrestrial plants (Tier 1) Bayer CropScience, Report No.: VV 10/002, Edition Number: M-397734-01-1 Date: 2010-12-14 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.8.1.3 /01

Gosch, H. 2010 BYI 02960 SL 200 g/L - Effects on the seedling emergence and growth of eleven species of non-target terrestrial plants (Tier 1) Bayer CropScience, Report No.: SE10/001, Edition Number: M-397727-01-1 Date: 2010-12-14 GLP/GEP: yes, unpublished


Y Y

Interzonal core: No additional studies compared to the list for the field core. NL addendum








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Annex point / reference number

Author(s) Year Title Source (where different from company) Company name, Report No., Date, GLP/GEP status (where relevant), published or not

Data protect. claimed



KIIIA 10.2.1 /01

van de Zande, J. C.; Michielsen, J. M. G. P.; Stallinga, H.

2014 Spray drift deposition of handheld Knapsack sprayers and weedsprayer on different non-target zones in the Netherlands Location:Wageningen, Journal:Plant Research International, Year:2014, Report No.: Report 579, Edition Number: M-493034-01-1 GLP/GEP: n.a., published


Yes Yes

KIIIA 10.5 /01

van de Zande, J. C.; Michielsen, J. M. G. P.; Stallinga, H.

2013 Spray drift deposition on different non-target zones in the Netherlands Location:Wageningen, Journal:Plant Research International, Year:2013, Report No.: M-468971-01-1, Edition Number: M-468971-01-1 GLP/GEP: n.a., published


Yes No

Efficacy Field crops:





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KIIIA 6 /01 Adriaansen, P.; Peeters, D.; Schrader, E.; Sorrequieta, J.; Voslajer, Z.; van Waetermeulen, X.

2014 Summary of the efficacy data and information on the plant protection product for flupyradifurone SL200 (200 g/L) - Central zone Bayer CropScience Bayer CropScience, Report No.: M-479228-02-1, Edition Number: M-479228-02-1 Date: 2014-04-23 GLP/GEP: n.a., unpublished


Y No (not claimed)

KIIIA 6.1.1 /01 Thielert, W. 2012 Study report for flupyradifurone SL 200 Bayer CropScience Bayer CropScience, Report No.: M-428101-01-1, Edition Number: M-428101-01-1 Date: 2012-03-29 GLP/GEP: n.a., unpublished


Yes No (not claimed)

KIIIA 6.1.2 /01 van Waetermeulen, X.

2012 Compilation of trial report for flupyradifurone SL200 flupyradifurone SL200 (200 g/L) - Minimum effective dose tests lettuce Bayer CropScience Bayer CropScience, Report No.: M-427719-01-1, Edition Number: M-427719-01-1 Date: 2012-03-27 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.2 /02 Voslajer, Z. 2012 Compilation of trial report for flupyradifurone SL200 flupyradifurone SL200 (200 g/L) - Minimum effective dose tests - hop Bayer CropScience Bayer CropScience, Report No.: M-427830-01-1, Edition Number: M-427830-01-1 Date: 2012-03-28 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.2 /03 Peeters, D. 2013 Compilation of trial reports for FPF SL200 (flupyradifurone 200 g/L) - Efficacy and dose rate finding studies in the control of the first generation of pear sucker Psylla pyri on pears - Studies in the European central zone Bayer CropScience Bayer CropScience, Report No.: M-462794-02-1, Edition Number: M-462794-02-1 Date: 2013-07-13 ...Amended: 2014-02-10 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /03


Yes Yes








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KIIIA 6.1.2 /04 Peeters, D. 2013 Compilation of trial reports for FPF SL200 (Flupyradifurone 200 g/L) - Efficacy and dose rate finding studies in the control of aphids in pre-flowering application on apple and pear - Studies in the European central zone Bayer CropScience Bayer CropScience, Report No.: M-462797-01-1, Edition Number: M-462797-01-1 Date: 2013-07-16 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /04


Yes Yes

KIIIA 6.1.2 /05 Peeters, D. 2013 Compilation of trial reports for FPF SL200 (flupyradifurone 200 g/L) - Efficacy and dose rate finding studies in the control of rosy apple aphid on apple - Post-flower application - Studies in the European central zone Bayer CropScience Bayer CropScience, Report No.: M-462804-01-1, Edition Number: M-462804-01-1 Date: 2013-08-22 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /05


Yes Yes

KIIIA 6.1.2 /06 Peeters, D. 2013 Compilation of trial reports for FPF SL200 (flupyradifurone 200 g/L) - Efficacy and dose rate finding studies in the control of green apple aphid on apple - Post-flower application - Studies in the European central zone Bayer CropScience Bayer CropScience, Report No.: M-462806-01-1, Edition Number: M-462806-01-1 Date: 2013-08-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /06


Yes Yes

KIIIA 6.1.2 /07 Versluis, P. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Minimum effective dose tests - Aphis fabae - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463455-01-1, Edition Number: M-463455-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.2 /08 Versluis, P. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Minimum effective dose tests - Aphis gossypii - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463456-01-1, Edition Number: M-463456-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Yes Yes







Sivanto Prime








KIIIA 6.1.2 /09 Sorrequieta, M. J. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Minimum effective dose tests & efficacy tests - Phyllaphis fagi - Tree nursery crops Bayer CropScience Bayer CropScience, Report No.: M-463472-01-1, Edition Number: M-463472-01-1 Date: 2013-06-14 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /10


Yes Yes

KIIIA 6.1.2 /10 Schrader, E. 2013 Compilation of trial reports for FPF SL200 - Central Europe - Empoasca vitis on grapes Bayer CropScience Bayer CropScience, Report No.: M-464502-01-1, Edition Number: M-464502-01-1 Date: 2013-09-13 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /12 ...also filed: KIIIA 6.2.1 /06


Yes Yes

KIIIA 6.1.2 /11 Schrader, E. 2013 Compilation of trial reports for FPF SL200 - Central Europe - Scaphoideus titanus on grapes Bayer CropScience Bayer CropScience, Report No.: M-464506-01-1, Edition Number: M-464506-01-1 Date: 2013-09-13 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /13 ...also filed: KIIIA 6.2.1 /07


Yes Yes

KIIIA 6.1.3 /01 Overeem, A. J. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Efficacy tests - Nasonovia ribisnigri - Lettuce Bayer CropScience Bayer CropScience, Report No.: M-463468-02-1, Edition Number: M-463468-02-1 Date: 2013-09-04 ...Amended: 2013-09-10 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.3 /02 Voslajer, Z. 2012 Compilation of trial report for flupyradifurone SL200 - Flupyradifurone SL200 (200 g/L) - Efficacy tests - Hop Bayer CropScience Bayer CropScience, Report No.: M-427966-02-1, Edition Number: M-427966-02-1 Date: 2012-03-28 ...Amended: 2013-09-25 GLP/GEP: yes, unpublished


Yes Yes







Sivanto Prime








KIIIA 6.1.3 /03 Peeters, D. 2013 Compilation of trial reports for FPF SL200 (flupyradifurone 200 g/L) - Efficacy and dose rate finding studies in the control of the first generation of pear sucker Psylla pyri on pears - Studies in the European central zone Bayer CropScience Bayer CropScience, Report No.: M-462794-02-1, Edition Number: M-462794-02-1 Date: 2013-07-13 ...Amended: 2014-02-10 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /03


Yes Yes

KIIIA 6.1.3 /04 Peeters, D. 2013 Compilation of trial reports for FPF SL200 (Flupyradifurone 200 g/L) - Efficacy and dose rate finding studies in the control of aphids in pre-flowering application on apple and pear - Studies in the European central zone Bayer CropScience Bayer CropScience, Report No.: M-462797-01-1, Edition Number: M-462797-01-1 Date: 2013-07-16 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /04


Yes Yes

KIIIA 6.1.3 /05 Peeters, D. 2013 Compilation of trial reports for FPF SL200 (flupyradifurone 200 g/L) - Efficacy and dose rate finding studies in the control of rosy apple aphid on apple - Post-flower application - Studies in the European central zone Bayer CropScience Bayer CropScience, Report No.: M-462804-01-1, Edition Number: M-462804-01-1 Date: 2013-08-22 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /05


Yes Yes

KIIIA 6.1.3 /06 Peeters, D. 2013 Compilation of trial reports for FPF SL200 (flupyradifurone 200 g/L) - Efficacy and dose rate finding studies in the control of green apple aphid on apple - Post-flower application - Studies in the European central zone Bayer CropScience Bayer CropScience, Report No.: M-462806-01-1, Edition Number: M-462806-01-1 Date: 2013-08-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /06


Yes Yes






Sivanto Prime








KIIIA 6.1.3 /07 Peeters, D. 2013 Compilation of trial reports for FPF SL200 (flupyradifurone 200 g/L) - Efficacy and dose rate finding studies in the control of apple sawfly and mullein plant bug on apple and pear - Post-flower application - Studies in the European central zone Bayer CropScience Bayer CropScience, Report No.: M-462807-02-1, Edition Number: M-462807-02-1 Date: 2013-08-27 ...Amended: 2013-09-16 GLP/GEP: no, unpublished


Yes Yes

KIIIA 6.1.3 /08 Versluis, P. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Efficacy tests - Aphis fabae - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463451-01-1, Edition Number: M-463451-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.3 /09 Versluis, P. G. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Efficacy tests - Aphis gossypii - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463453-01-1, Edition Number: M-463453-01-1 Date: 2013-05-31 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.3 /10 Sorrequieta, M. J. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Minimum effective dose tests & efficacy tests - Phyllaphis fagi - Tree nursery crops Bayer CropScience Bayer CropScience, Report No.: M-463472-01-1, Edition Number: M-463472-01-1 Date: 2013-06-14 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /09


Yes Yes

KIIIA 6.1.3 /11 Adriaansen, P. A. E.

2013 Compilation of trial report for Sivanto - flupyradifurone SL200 (200 g/L) - efficacy tests - aphids - outdoor ornamentals Bayer CropScience Bayer CropScience, Report No.: M-465876-01-1, Edition Number: M-465876-01-1 Date: 2013-10-04 GLP/GEP: yes, unpublished


Yes Yes







Sivanto Prime










Yes Yes



Yes Yes

KIIIA 6.1.3 /14 Lheureux, F. 2013 Compilation of trial report for FPF SL 200 - Efficacy tests - Flupyradifurone SL200 (200 g/L) - Vine Bayer CropScience Bayer CropScience, Report No.: M-468678-01-1, Edition Number: M-468678-01-1 Date: 2013-10-10 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.4 /01 Voslajer, Z. 2012 Compilation of trial report for flupyradifurone SL200 - Flupyradifurone SL200 (200 g/L) - Effects on yield and quality - Hop - KIIIA 6.1.4 Bayer CropScience Bayer CropScience, Report No.: M-428476-01-1, Edition Number: M-428476-01-1 Date: 2012-03-28 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.4.1 /01

Peeters, D. 2013 Compilation of trial reports for FPF SL200 (flupyradifurone 200 g/L) - Impact on the yield and the quality of harvested fruits in pomefruits - Studies in the European central zone Bayer CropScience Bayer CropScience, Report No.: M-462809-02-1, Edition Number: M-462809-02-1 Date: 2013-08-28 ...Amended: 2013-08-29 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.3 /02


Yes Yes







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KIIIA 6.1.4.2 /01

Vostrel, J. 2011 Final report of processing phase - Field study to generate specimens of hops sprayed with BYI02960 200 SL in the Czech Republic for subsequent micro brewing and triangle taint tests during 2010 SAGEA Centro di Saggio s.r.l., Castagnito d’Alba, Italy Bayer CropScience, Report No.: 10BAY929ZA01, Report includes Trial Nos.: 10BAY929ZA01 Edition Number: M-401324-01-1 Date: 2011-01-07 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.4.2 /02

Vostrel, J. 2013 Final report of processing phase - Field study to generate specimens of hops sprayed with Flupyradifurone SL200 (SP102000021884) and Spirotetramat SC100 (SP102000016538) in the Czech Republic for subsequent micro brewing and triangle taint tests during 2012 Hop Research Institute, Zatec, Czech Republic Bayer CropScience, Report No.: M-445117-01-1, Edition Number: M-445117-01-1 Date: 2013-01-03 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.4.2 /03

Aston, C. 2011 Field study to generate specimens of field hop treated with Spec 102000021884; 2 sites in Germany, 2010 Eurofins Agroscience Services Limited, Melbourne, Wilson, United Kingdom Bayer CropScience, Report No.: S10-01180, Edition Number: M-445458-01-1 Date: 2011-07-08 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.4.2 /04

Aston, C. 2012 Field study to generate specimens of hop treated with Spec 102000021884, 2 sites in Germany, 2011 Eurofins Agroscience Services Limited, Melbourne, Wilson, United Kingdom Bayer CropScience, Report No.: S11-01329, Edition Number: M-445453-01-1 Date: 2012-06-29 GLP/GEP: yes, unpublished


Yes Yes






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KIIIA 6.1.4.2 /05

Van Waetermeulen, X.

2013 Compilation of studies reports for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Effects on the processing procedure - Apple - KIIIA 6.1.4.2 Eurofins Agroscience Services Limited, Melbourne, United Kingdom Bayer CropScience, Report No.: M-448323-01-1, Edition Number: M-448323-01-1 Date: 2013-02-13 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.4.2 /06

van Waetermeulen, X.

2013 Compilation of studies reports for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Effects on the processing procedure - Lettuce Bayer CropScience Bayer CropScience, Report No.: M-446916-01-1, Edition Number: M-446916-01-1 Date: 2013-02-13 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.4.2 /07


2013 Compilation of studies reports for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Effects on the processing procedure - Wine grapes in central zone Bayer CropScience Bayer CropScience, Report No.: M-457956-01-1, Edition Number: M-457956-01-1 Date: 2013-06-25 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.4.3 /01


2013 Compilation of trial report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Impact on the quality and yield of treated plants and plant products in greenhouse lettuce and tomato Bayer CropScience Bayer CropScience, Report No.: M-460604-01-1, Edition Number: M-460604-01-1 Date: 2013-07-25 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.1.4.3 /02

Peeters, D. 2013 Compilation of trial reports for FPF SL200 (flupyradifurone 200 g/L) - Impact on the yield and the quality of harvested fruits in pomefruits - Studies in the European central zone Bayer CropScience Bayer CropScience, Report No.: M-462809-02-1, Edition Number: M-462809-02-1 Date: 2013-08-28 ...Amended: 2013-08-29 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.1 /01


Yes Yes







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KIIIA 6.1.4.3 /03

Versluis, P. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Effects on yield and quality - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463439-01-1, Edition Number: M-463439-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.2.1 /01 Overeem, A. J. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Phytotoxicity to host crop - Lettuce Bayer CropScience Bayer CropScience, Report No.: M-463479-01-1, Edition Number: M-463479-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.2.1 /02 Versluis, P. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Phytotoxicity to host crop - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463459-01-1, Edition Number: M-463459-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.2.1 /03 Sorrequieta, M. J. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Phytotoxicity to host crop - Tree nursery crops Bayer CropScience Bayer CropScience, Report No.: M-463495-01-1, Edition Number: M-463495-01-1 Date: 2013-06-14 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.2.1 /04 Sorrequieta, M. J. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Efficacy tests - Trialeurodes vaporariorum - Ornamentals Bayer CropScience Bayer CropScience, Report No.: M-463471-01-1, Edition Number: M-463471-01-1 Date: 2013-06-14 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.2.1 /05 Sorrequieta, M. J. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Phytotoxicity to host crop - Ornamentals Bayer CropScience Bayer CropScience, Report No.: M-463478-01-1, Edition Number: M-463478-01-1 Date: 2013-06-14 GLP/GEP: yes, unpublished


Yes Yes








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Yes Yes



Yes Yes

KIIIA 6.2.5 /01 Versluis, P. 2013 Compilation of trial report for Sivanto - Flupyradifurone SL200 (200 g/L) - Adverse effects on parts of plants used for propagating purposes - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463450-01-1, Edition Number: M-463450-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.2.8 /01 Nauen, R. 2013 Statement: Possible development of resistance or cross-resistance flupyradifurone (BYI 2960) Bayer CropScience, Report No.: M-428792-02-1, Edition Number: M-428792-02-1 Date: 2013-11-08 GLP/GEP: n.a., unpublished


Yes No (not claimed)

KIIIA 6.5 /01 van Waetermeulen, X.

2013 Compilation of trial report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Biological evaluation of the rainfastness in cauliflower and lettuce Bayer CropScience Bayer CropScience, Report No.: M-450413-01-1, Edition Number: M-450413-01-1 Date: 2013-04-04 GLP/GEP: yes, unpublished


Yes Yes

KIIIA 6.5 /02 Lamprecht, S. 2013 Study report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Speed of action against aphids and temperature effect Bayer CropScience, Report No.: M-466937-01-1, Edition Number: M-466937-01-1 Date: 2013-10-16 GLP/GEP: yes, unpublished


Yes Yes

Protected crops:








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Owner Study used y/n

Data protection granted y/n

KIIIA 6 /01 Adriaansen, P.; Izquierdo C. J.; Lheureux, F.; Sorrequieta, J.; van Waetermeulen, X.

2014 Summary of the efficacy data and information on the plant protection product for flupyradifurone SL200 (200 g/L) - Protected crops Bayer CropScience Bayer CropScience, Report No.: M-479245-02-1, Edition Number: M-479245-02-1 Date: 2014-02-24 GLP/GEP: n.a., unpublished


yes No (not claimed)

KIIIA 6.1.1 /01 Thielert, W. 2012 Study report for flupyradifurone SL 200 Bayer CropScience Bayer CropScience, Report No.: M-428101-01-1, Edition Number: M-428101-01-1 Date: 2012-03-29 GLP/GEP: n.a., unpublished


yes No (not claimed)


2013 Compilation of trial report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Minimum effective dose and efficacy trials against Nasonovia ribisnigri and Macrosiphum euphorbiae, in field and protected lettuce Bayer CropScience Bayer CropScience, Report No.: M-459370-02-1, Edition Number: M-459370-02-1 Date: 2013-07-12 ...Amended: 2013-12-20 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /05


Y Y


2013 Compilation of trial report for FPF SL200 - Flupyradifurone SL200 g/L - Minimum effective dose rate against Bemisia tabaci and Trialeurodes vaporariorum Bayer CropScience Bayer CropScience, Report No.: M-460024-01-1, Edition Number: M-460024-01-1 Date: 2013-07-15 GLP/GEP: yes, unpublished


Y Y


2013 Compilation of trial report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Minimum effective dose rate against aphids (Aphis gossypii; Myzus persicae; Macrosiphum euphorbiae) in indoor fruiting vegetables Bayer CropScience Bayer CropScience, Report No.: M-459375-01-1, Edition Number: M-459375-01-1 Date: 2013-07-12 GLP/GEP: yes, unpublished


Y Y


2013 Compilation of trial report for FPF SL200 Bayer CropScience Bayer CropScience, Report No.: M-460524-01-1, Edition Number: M-460524-01-1 Date: 2013-07-12 GLP/GEP: yes, unpublished


Y Y








Sivanto Prime








KIIIA 6.1.2 /05 Lheureux, F. 2013 Compilation of trial report for FPF SL 200 - Minimum effective dose tests - Flupyradifurone SL200 (200 g/L) - Strawberry Bayer CropScience Bayer CropScience, Report No.: M-464535-01-1, Edition Number: M-464535-01-1 Date: 2013-09-10 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.2.1 /04


Y Y

KIIIA 6.1.2 /06 Sorrequieta, M. J. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Minimum effective dose tests - Trialeurodes vaporariorum - Ornamentals Bayer CropScience Bayer CropScience, Report No.: M-463477-01-1, Edition Number: M-463477-01-1 Date: 2013-06-14 GLP/GEP: yes, unpublished


Y Y

KIIIA 6.1.2 /07 Versluis, P. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Minimum effective dose tests - Aphis fabae - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463455-01-1, Edition Number: M-463455-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Y Y

KIIIA 6.1.2 /08 Versluis, P. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Minimum effective dose tests - Aphis gossypii - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463456-01-1, Edition Number: M-463456-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Y Y

KIIIA 6.1.2 /09 Sorrequieta, M. J. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Minimum effective dose tests & efficacy tests - Phyllaphis fagi - Tree nursery crops Bayer CropScience Bayer CropScience, Report No.: M-463472-01-1, Edition Number: M-463472-01-1 Date: 2013-06-14 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /03


Y Y







Sivanto Prime








KIIIA 6.1.2 /10 Schwarz, B. 2013 Compilation of trial reports for Sivanto Prime - flupyradifurone 50 SL (50 g/l) - Minimum effective dose against whiteflies on ornamentals in home, gardens and allotments - Europe, all zones - Bayer CropScience, Report No.: M-467421-01-1, Edition Number: M-467421-01-1 Date: 2013-10-08 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /08


Y Y

KIIIA 6.1.2 /11 Schwarz, B. 2013 Compilation of trial reports for Sivanto Prime - flupyradifurone 50 SL (50 g/l) - Efficacy against aphids on ornamentals in home, gardens and allotments, trials under protected conditions (indoor) - Europe, all zones - Bayer CropScience, Report No.: M-467356-01-1, Edition Number: M-467356-01-1 Date: 2013-10-16 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /09


Y Y

KIIIA 6.1.3 /01 Versluis, P. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Efficacy tests - Aphis fabae - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463451-01-1, Edition Number: M-463451-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Y Y

KIIIA 6.1.3 /02 Versluis, P. G. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Efficacy tests - Aphis gossypii - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463453-01-1, Edition Number: M-463453-01-1 Date: 2013-05-31 GLP/GEP: yes, unpublished


Y Y

KIIIA 6.1.3 /03 Sorrequieta, M. J. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Minimum effective dose tests & efficacy tests - Phyllaphis fagi - Tree nursery crops Bayer CropScience Bayer CropScience, Report No.: M-463472-01-1, Edition Number: M-463472-01-1 Date: 2013-06-14 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /09


Y Y







Sivanto Prime








KIIIA 6.1.3 /04 Sorrequieta, M. J. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Efficacy tests - Trialeurodes vaporariorum - Ornamentals Bayer CropScience Bayer CropScience, Report No.: M-463471-01-1, Edition Number: M-463471-01-1 Date: 2013-06-14 GLP/GEP: yes, unpublished


Y Y


2013 Compilation of trial report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Minimum effective dose and efficacy trials against Nasonovia ribisnigri and Macrosiphum euphorbiae, in field and protected lettuce Bayer CropScience Bayer CropScience, Report No.: M-459370-02-1, Edition Number: M-459370-02-1 Date: 2013-07-12 ...Amended: 2013-12-20 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /01


Y Y

KIIIA 6.1.3 /06 Izquierdo, J. 2013 Compilation of trial report for flupyradifurone SL200 (Sivanto Prime) - Efficacy and plant safety tests on fruiting vegetables S-EU Bayer CropScience Bayer CropScience, Report No.: M-464397-01-1, Edition Number: M-464397-01-1 Date: 2013-08-30 GLP/GEP: yes, unpublished


Y Y

KIIIA 6.1.3 /07 Lheureux, F. 2013 Compilation of trial report for FPF SL 200 - Minimum effective dose tests flupyradifurone SL200 (200 g/L) - Strawberry Bayer CropScience Bayer CropScience, Report No.: M-465382-01-1, Edition Number: M-465382-01-1 Date: 2013-09-10 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.2.1 /05


Y Y

KIIIA 6.1.3 /08 Schwarz, B. 2013 Compilation of trial reports for Sivanto Prime - flupyradifurone 50 SL (50 g/l) - Minimum effective dose against whiteflies on ornamentals in home, gardens and allotments - Europe, all zones - Bayer CropScience, Report No.: M-467421-01-1, Edition Number: M-467421-01-1 Date: 2013-10-08 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /10


Y Y







Sivanto Prime








KIIIA 6.1.3 /09 Schwarz, B. 2013 Compilation of trial reports for Sivanto Prime - flupyradifurone 50 SL (50 g/l) - Efficacy against aphids on ornamentals in home, gardens and allotments, trials under protected conditions (indoor) - Europe, all zones - Bayer CropScience, Report No.: M-467356-01-1, Edition Number: M-467356-01-1 Date: 2013-10-16 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /11


Y Y

KIIIA 6.1.4.1 /01 Van Waetermeulen, X.

2013 Compilation of trial report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Impact on the quality and yield of treated plants and plant products in greenhouse lettuce and tomato Bayer CropScience Bayer CropScience, Report No.: M-460604-01-1, Edition Number: M-460604-01-1 Date: 2013-07-25 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.3 /01 ...also filed: KIIIA 6.2.1 /06


Y Y


2013 Compilation of trial report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Impact of FPF SL200 on the quality of strawberry Bayer CropScience Bayer CropScience, Report No.: M-465469-01-1, Edition Number: M-465469-01-1 Date: 2013-07-25 GLP/GEP: yes, unpublished


Y Y


2013 Compilation of studies reports for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Effects on the processing procedure - Raspberry - KIIIA 6.1.4.2 Eurofins Agroscience Services Limited, Melbourne, United Kingdom Bayer CropScience, Report No.: M-448321-01-1, Edition Number: M-448321-01-1 Date: 2013-02-14 GLP/GEP: yes, unpublished


Y Y


2013 Compilation of studies reports for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Effects on the processing procedure - Tomato Bayer CropScience Bayer CropScience, Report No.: M-446914-01-1, Edition Number: M-446914-01-1 Date: 2013-02-13 GLP/GEP: yes, unpublished


Y Y







Sivanto Prime








KIIIA 6.1.4.2 /03 van Waetermeulen, X.

2013 Compilation of studies reports for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Effects on the processing procedure - Lettuce Bayer CropScience Bayer CropScience, Report No.: M-446916-01-1, Edition Number: M-446916-01-1 Date: 2013-02-13 GLP/GEP: yes, unpublished


Y Y


2013 Compilation of studies reports for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Effects on the processing procedure - Strawberry - KIIIA 6.1.4.2 Eurofins Agroscience Services Limited, Melbourne, United Kingdom Bayer CropScience, Report No.: M-448324-01-1, Edition Number: M-448324-01-1 Date: 2013-03-05 GLP/GEP: yes, unpublished


Y Y


2013 Compilation of trial report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Impact on the quality and yield of treated plants and plant products in greenhouse lettuce and tomato Bayer CropScience Bayer CropScience, Report No.: M-460604-01-1, Edition Number: M-460604-01-1 Date: 2013-07-25 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.1 /01 ...also filed: KIIIA 6.2.1 /06


Y Y

KIIIA 6.2.1 /01 Versluis, P. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Phytotoxicity to host crop - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463459-01-1, Edition Number: M-463459-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Y Y

KIIIA 6.2.1 /02 Sorrequieta, M. J. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Phytotoxicity to host crop - Tree nursery crops Bayer CropScience Bayer CropScience, Report No.: M-463495-01-1, Edition Number: M-463495-01-1 Date: 2013-06-14 GLP/GEP: yes, unpublished


Y Y

KIIIA 6.2.1 /03 Sorrequieta, M. J. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Phytotoxicity to host crop - Ornamentals Bayer CropScience Bayer CropScience, Report No.: M-463478-01-1, Edition Number: M-463478-01-1 Date: 2013-06-14 GLP/GEP: yes, unpublished


Y Y








Sivanto Prime








KIIIA 6.2.1 /04 Lheureux, F. 2013 Compilation of trial report for FPF SL 200 - Minimum effective dose tests - Flupyradifurone SL200 (200 g/L) - Strawberry Bayer CropScience Bayer CropScience, Report No.: M-464535-01-1, Edition Number: M-464535-01-1 Date: 2013-09-10 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /05


Y Y

KIIIA 6.2.1 /05 Lheureux, F. 2013 Compilation of trial report for FPF SL 200 - Minimum effective dose tests flupyradifurone SL200 (200 g/L) - Strawberry Bayer CropScience Bayer CropScience, Report No.: M-465382-01-1, Edition Number: M-465382-01-1 Date: 2013-09-10 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /07


Y Y

KIIIA 6.2.1 /06 Van Waetermeulen, X.

2013 Compilation of trial report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Impact on the quality and yield of treated plants and plant products in greenhouse lettuce and tomato Bayer CropScience Bayer CropScience, Report No.: M-460604-01-1, Edition Number: M-460604-01-1 Date: 2013-07-25 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.1 /01 ...also filed: KIIIA 6.1.4.3 /01


Y Y

KIIIA 6.2.1 /07 Izquierdo, J. 2013 Compilation of trial report for flupyradifurone SL200 (Sivanto Prime) - Plant safety tests on fruiting vegetables GH-EU Bayer CropScience Bayer CropScience, Report No.: M-464484-01-1, Edition Number: M-464484-01-1 Date: 2013-08-30 GLP/GEP: yes, unpublished


Y Y

KIIIA 6.2.5 /01 Versluis, P. 2013 Compilation of trial report for Sivanto Prime - Flupyradifurone SL200 (200 g/L) - Adverse effects on parts of plants used for propagating purposes - Flowerbulbs Bayer CropScience Bayer CropScience, Report No.: M-463450-01-1, Edition Number: M-463450-01-1 Date: 2013-09-04 GLP/GEP: yes, unpublished


Y Y

KIIIA 6.2.8 /01 Nauen, R. 2013 Statement: Possible development of resistance or cross-resistance flupyradifurone (BYI 2960) Bayer CropScience, Report No.: M-428792-02-1, Edition Number: M-428792-02-1 Date: 2013-11-08 GLP/GEP: n.a., unpublished


no No (not claimed)








Sivanto Prime








KIIIA 6.5 /01 Lamprecht, S. 2013 Study report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Speed of action against aphids and temperature effect Bayer CropScience, Report No.: M-466937-01-1, Edition Number: M-466937-01-1 Date: 2013-10-16 GLP/GEP: yes, unpublished


Y Y



Sivanto Prime



Non-relevance groundwater metabolites: -


Sivanto Prime



Reference List for the active substance flupyradifurone (|EU annex II dossier)


Sivanto Prime




Author(s) Year

Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), published or not


Data protection

granted Y/N

Owner Application number of first submssion

Date of first submission (Edition)

KIIA 2.1.1 /01

Smeykal, H. 2010

BYI 02960, pure substance: Melting point, boiling point, thermal stability Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20090051.01, Edition Number: M-367370-01-1 Date: 2010-03-25 GLP/GEP: yes, unpublished ...also filed: KIIA 2.1.2 /01 ...also filed: KIIA 2.1.3 /01

Yes Y Bayer CropScience

20120484 TGEURAP

2012-05-08

KIIA 2.1.1 /02

Smeykal, H. 2011

Flupyradifurone (BYl 02960), technical substance: Melting point, boiling point, thermal stability Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20110197.01, Edition Number: M-414242-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished ...also filed: KIIA 2.1.2 /02 ...also filed: KIIA 2.1.3 /02


20120484 TGEURAP

2012-05-08

KIIA 2.1.2 /01

Smeykal, H. 2010



20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 2.1.2 /02

Smeykal, H. 2011



20120484 TGEURAP

2012-05-08

KIIA 2.1.3 /01

Smeykal, H. 2010



20120484 TGEURAP

2012-05-08

KIIA 2.1.3 /02

Smeykal, H. 2011



20120484 TGEURAP

2012-05-08

KIIA 2.2 /01

Bogdoll, B.; Strunk, B.

2011

Flupyradifurone (BYI 02960), pure substance: Relative density Bayer CropScience, Report No.: PA09/006, Edition Number: M-412635-01-1 Date: 2011-08-18 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 2.2 /02

Eyrich, U.; Bogdoll, B.

2011

Flupyradifurone (BYI 02960), technical substance : Relative density Bayer CropScience, Report No.: PA11/063, Edition Number: M-414075-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.3.1 /01

Smeykal, H. 2008

BYI 02960, pure substance: Vapour pressure - Final report Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20080615.01, Edition Number: M-309853-01-1 Date: 2008-10-10 GLP/GEP: yes, unpublished ...also filed: KIIA 7.4.9 /01


20120484 TGEURAP

2012-05-08

KIIA 2.4.1 /01


2011

Flupyradifurone (BYI 02960), pure substance - Physical characteristics colour, physical state and odour Bayer CropScience, Report No.: PA09/008, Edition Number: M-412655-01-1 Date: 2011-08-18 GLP/GEP: yes, unpublished ...also filed: KIIA 2.4.2 /01


20120484 TGEURAP

2012-05-08

KIIA 2.4.1 /02


2011

Flupyradifurone (BYI 02960), technical substance: Physical characteristics colour, physical state and odour Bayer CropScience, Report No.: PA11/062, Edition Number: M-414072-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished ...also filed: KIIA 2.4.2 /02


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 2.4.2 /01


2011

Flupyradifurone (BYI 02960), pure substance - Physical characteristics colour, physical state and odour Bayer CropScience, Report No.: PA09/008, Edition Number: M-412655-01-1 Date: 2011-08-18 GLP/GEP: yes, unpublished ...also filed: KIIA 2.4.1 /01


20120484 TGEURAP

2012-05-08

KIIA 2.4.2 /02


2011

Flupyradifurone (BYI 02960), technical substance: Physical characteristics colour, physical state and odour Bayer CropScience, Report No.: PA11/062, Edition Number: M-414072-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished ...also filed: KIIA 2.4.1 /02


20120484 TGEURAP

2012-05-08

KIIA 2.5.1.1 /01

Peters; S. 2009

Spectral data set of BYI 02960 a.i. - Reference material Bayer CropScience, Report No.: 15-600-2439, Edition Number: M-345761-01-1 Date: 2009-04-07 GLP/GEP: yes, unpublished ...also filed: KIIA 2.5.1.2 /01 ...also filed: KIIA 2.5.1.3 /01 ...also filed: KIIA 2.5.1.4 /01 ...also filed: KIIA 2.5.1.5 /01


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 2.5.1.2 /01

Peters; S. 2009



20120484 TGEURAP

2012-05-08

KIIA 2.5.1.3 /01

Peters; S. 2009



20120484 TGEURAP

2012-05-08

KIIA 2.5.1.4 /01

Peters; S. 2009



20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 2.5.1.5 /01

Peters; S. 2009



20120484 TGEURAP

2012-05-08

KIIA 2.6 /01

Wiche, A.; Bogdoll, B.

2011

BYI 02960, pure substance: Solubility in distilled water (pH 7), at pH 4 and pH 9 (flask method) Bayer CropScience, Report No.: PA09/003, Edition Number: M-409513-01-1 Date: 2011-06-17 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.7 /01


2011

Flupyradifurone (BYI 02960): Solubility in organic solvents Bayer CropScience, Report No.: PA09/005, Edition Number: M-414064-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.8.1 /01


2011

Flupyradifurone (BYI 02960), pure substance: Partition coefficient 1-octanol / water at pH 4, pH 7 and pH 9 (HPLC-method) Bayer CropScience, Report No.: PA09/004, Edition Number: M-414485-01-1 Date: 2011-09-26 GLP/GEP: yes, unpublished ...also filed: KIIA 2.8.2 /01


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 2.8.2 /01


2011

Flupyradifurone (BYI 02960), pure substance: Partition coefficient 1-octanol / water at pH 4, pH 7 and pH 9 (HPLC-method) Bayer CropScience, Report No.: PA09/004, Edition Number: M-414485-01-1 Date: 2011-09-26 GLP/GEP: yes, unpublished ...also filed: KIIA 2.8.1 /01


20120484 TGEURAP

2012-05-08

KIIA 2.9.1 /01

Mislankar, S.; Woodard, D.

2011

BYI-02960: Hydrolytic degradation Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP019, Edition Number: M-398952-01-1 Date: 2011-01-07 GLP/GEP: yes, unpublished ...also filed: KIIA 7.5 /01


20120484 TGEURAP

2012-05-08

KIIA 2.9.2 /01

Hall, L. R. 2011

Phototransformation of [14C]BYI 02960 in aqueous pH 7 buffer - amended report Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP042-1, Edition Number: M-418426-02-1 Date: 2011-11-28 ...Amended: 2012-03-05 GLP/GEP: yes, unpublished ...also filed: KIIA 2.9.4 /01 ...also filed: KIIA 7.6 /01


20120484 TGEURAP

2012-05-08

KIIA 2.9.3 /01

Heinemann, O.

2011

BYI 02960: Determination of the quantum yield and assessment of the environmental half-life of the direct photo-degradation in water Bayer CropScience, Report No.: MEF-11/554, Edition Number: M-414756-01-2 EPA MRID No.: 48843668 Date: 2011-09-26 GLP/GEP: yes, unpublished ...also filed: KIIA 2.9.4 /02 ...also filed: KIIA 7.6 /02


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 2.9.4 /01

Hall, L. R. 2011

Phototransformation of [14C]BYI 02960 in aqueous pH 7 buffer - amended report Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP042-1, Edition Number: M-418426-02-1 Date: 2011-11-28 ...Amended: 2012-03-05 GLP/GEP: yes, unpublished ...also filed: KIIA 2.9.2 /01 ...also filed: KIIA 7.6 /01


20120484 TGEURAP

2012-05-08

KIIA 2.9.4 /02

Heinemann, O.

2011

BYI 02960: Determination of the quantum yield and assessment of the environmental half-life of the direct photo-degradation in water Bayer CropScience, Report No.: MEF-11/554, Edition Number: M-414756-01-2 EPA MRID No.: 48843668 Date: 2011-09-26 GLP/GEP: yes, unpublished ...also filed: KIIA 2.9.3 /01 ...also filed: KIIA 7.6 /02


20120484 TGEURAP

2012-05-08

KIIA 2.9.5 /01


2011

Flupyradifurone (BYI 02960), pure substance : Dissociation constant in water Bayer CropScience, Report No.: PA10/048, Edition Number: M-414102-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.10 /01

Hellpointner; E.

2010

BYI 02960: Calculation of the chemical half-life in the troposphere Bayer CropScience, Report No.: MEF-10/896, Edition Number: M-398741-01-2 EPA MRID No.: 48843671 Date: 2010-12-27 GLP/GEP: no, unpublished ...also filed: KIIA 7.10 /01

No Y Bayer CropScience

20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 2.11.1 /01

Smeykal, H. 2011

Flupyradifurone (BYl 02960), technical substance: flammability (solids) Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20110197.03, Edition Number: M-414249-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.11.2 /01

Smeykal, H. 2011

Flupyradifurone (BYl 02960), technical substance: auto-flammability Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20110197.05, Edition Number: M-414252-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.11.2 /02

Smeykal, H. 2011

Flupyradifurone (BYl 02960), technical substance: autoflammability (UN Bowes Cameron Cage Test) Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20110197.07, Edition Number: M-414257-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.13 /01

Smeykal, H. 2011

Flupyradifurone (BYl 02960), technical substance: explosive properties Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20110197.04, Edition Number: M-414250-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 2.14 /01


2011

Flupyradifurone (BYI 02960), technical substance : Determination of the surface tension Bayer CropScience, Report No.: PA11/065, Edition Number: M-414086-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.15 /01

Smeykal, H. 2011

Flupyradifurone (BYl 02960), technical substance: oxidizing properties Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20110197.06, Edition Number: M-414253-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.16 /01


2011

Flupyradifurone (BYI 02960), pure substance: Determination of the pH-value in distilled water Bayer CropScience, Report No.: PA09/007, Edition Number: M-412128-01-1 Date: 2011-08-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.16 /02


2011

Flupyradifurone (BYI 02960), technical substance : Determination of the pH-value in distilled water Bayer CropScience, Report No.: PA11/064, Edition Number: M-414084-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.17.1 /01

Wagner, S. 2011

Chemical storage stability of BYI 02960 - Flupyradifurone (BYI 02960) Bayer CropScience, Report No.: 15-155-2438, Edition Number: M-411305-01-1 Date: 2011-07-19 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08












Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 2.17.2 /01

Wagner, S. 2011

Stability to normal and elevated temperature, metals, and metal ions and corrosion characteristics to plastic containers of flupyradifurone (BYI 02960) according to OPPTS 830.6313 and 830.6320 Bayer CropScience, Report No.: 15-160-2527, Edition Number: M-413798-01-1 Date: 2011-09-12 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.18 /01


2011

Flupyradifurone (BYI 02960), technical substance : The oxidation or reduction properties Bayer CropScience, Report No.: PA11/066, Edition Number: M-414080-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.18 /02

Petrovic, P. 2011

Flupyradifurone (BYI 02960), technical substance: Complex formation ability in water Allessa Chemie GmbH, Frankfurt am Main, Germany Bayer CropScience, Report No.: B 015/2011, Edition Number: M-414563-01-1 Date: 2011-09-21 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 2.18 /03

Smeykal, H. 2011

Flupyradifurone (BYl 02960), technical substance: Particle size distribution Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20110197.02, Edition Number: M-414246-01-1 Date: 2011-09-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 4.2.1 /02

Wagner, S. 2011

Validation of AM008809MP1 - Flupyradifurone (BYI 02960) - Determination of technical grade active substance HPLC - ISTD Bayer CropScience, Report No.: VB1-AM008809MP1, Edition Number: M-409002-01-1 Date: 2011-06-06 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 4.3 /01

Schulte, G.; Bauer, J.

2012

Analytical method 01330 for the determination of residues of BYI 02960 and its metabolite difluoroacetic acid in/on plant matrix by HPLC-MS/MS - Enforcement method plant Bayer CropScience, Report No.: 01330, Edition Number: M-425848-01-1 Method Report No.: 01330 Date: 2012-02-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 4.3 /02

Konrad, S. 2012

Independent lab validation of BCS method 01330 for the determination of residues of BYI 02960 and its metabolite difluoroacetic acid in/on plant matrices by HPLC-MS/MS Currenta GmbH & Co. OHG, Leverkusen, Germany Bayer CropScience, Report No.: 2011/0134/01, Edition Number: M-427133-01-1 Method Report No.: 2011/0134/01 EPA MRID No.: 48843818 Date: 2012-02-28 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08












Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 4.3 /03

Li, Y.; Schoening, R.

2011

Amendment No. 1 - Validation of Bayer CropScience method RV-001-P10-02 - An analytical method for the determination of residues of BYI 02960, 6-chloronicotinic acid, difluoroacetic acid, and difluoroethyl-amino-furanone in plant matrices using LC/MS/MS Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVP013, Edition Number: M-415504-02-1 Method Report No US: RARVP013 Date: 2011-10-12 ...Amended: 2012-01-11 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 4.3 /04

Justus, K. 2011

Extraction efficiency testing of the residue analytical method RV-001-P10-02 for the determination of BYI 02960, 6-chloronicotinic acid, difluoroacetic acid and difluoroethyl-amino-furanone in plant matrices using aged radioactive residues Bayer CropScience, Report No.: MEF-11/793, Edition Number: M-419323-01-1 EPA MRID No.: 48843821 Date: 2011-12-01 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 4.3 /05

Rosati, D. 2012

Analytical method no 01212 for the determination of residues of BYI 02960 and its metabolites BCS-AA56716 (DFA), AE F161089 (6CNA) and BCS-CC98193 (furanone) in/on plant material by HPLC-MS/MS Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 01212, Edition Number: M-428017-01-1 Method Report No.: MR-10/174 Date: 2012-03-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 4.3 /06


2012

Analytical method 01214 for the determination of residues of BYI 02960 and its metabolite difluoroacetic acid in/on animal matrices by HPLC-MS/MS - Enforcement method animal Bayer CropScience, Report No.: 01214, Edition Number: M-425837-01-1 Method Report No.: 01214 EPA MRID No.: 48843825 Date: 2012-02-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 4.3 /07

Konrad, S. 2012

Independent lab validation of BCS method 01214 for the determination of residues of BYI 02960 and its metabolite difluoroacetic acid in/on animal matrices by HPLC-MS/MS Currenta GmbH & Co. OHG, Leverkusen, Germany Bayer CropScience, Report No.: 2011/0164/01, Edition Number: M-427160-01-1 Method Report No.: 2011/0164/01 EPA MRID No.: 48843826 Date: 2012-02-28 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 4.3 /08

2012

BYI 02960 - Magnitude of the residue in dairy cows - Amended report Bayer CropScience, Report No.: RARVP050-1, Edition Number: M-428416-02-1 EPA MRID No.: 48843842 Date: 2012-04-03 ...Amended: 2012-05-31 GLP/GEP: yes, unpublished ...also filed: KIIA 6.1.1 /02 ...also filed: KIIA 6.4.2 /01


20120484 TGEURAP

2012-05-08 (M-428416-01-1)

KIIA 4.3 /09

. 2012

BYI 02960 - Magnitude of the residue in laying hens Bayer CropScience, Report No.: RARVP041, Edition Number: M-428933-01-1 Date: 2012-04-05 GLP/GEP: yes, unpublished ...also filed: KIIA 6.4.1 /01


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 4.3 /10


2012

Modification M001 of the analytical method 01330 for the determination of residues of BYI 02960 and its metabolite difluoroacetic acid in/on plant matrix by HPLC-MS/MS- Enforcement method plant Bayer CropScience, Report No.: MR-12/054, Edition Number: M-438310-01-1 Date: 2012-09-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 4.3 /11

Konrad, S. 2012

Independent lab validation of BCS method 01330/M001 for the determination of residues of BYI 02960 and its metabolite difluoroacetic acid in/on plant matrices by HPLC-MS/MS Currenta GmbH & Co. OHG, Leverkusen, Germany Bayer CropScience, Report No.: 01330/M001, Edition Number: M-439855-01-1 Date: 2012-10-15 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 4.4 /01

Brumhard, B.: Reineke, A.

2009

Analytical method 01074 for the determination of BYI 02960 in soil using LC/MS/MS Bayer CropScience, Report No.: 01074, Edition Number: M-337752-01-1 Method Report No.: MR-07/337 Date: 2009-02-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 4.5 /01

Fargeix, G.; Rosati, D.

2012

Analytical method no 01213 for the determination of residues of BYI 02960 in drinking and surface water by HPLC-MS/MS Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 01213, Edition Number: M-428019-01-1 Method Report No.: MR-12/022 Date: 2012-03-29 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 4.7 /01

Heinz, N. 2011

BYI 02960: Analytical method for determination in air PTRL Europe GmbH, Ulm, Germany Bayer CropScience, Report No.: P 2419 G, Edition Number: M-420657-01-1 EPA MRID No.: 48843838 Date: 2011-12-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 5.1.1 /01

. 2012

[Pyridinylmethyl-14C]BYI 02960 - Absorption, distribution, excretion, and metabolism in the rat Bayer CropScience, Report No.: MEF-11/747, Edition Number: M-422210-01-1 EPA MRID No.: 48844141 Date: 2012-01-12 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.1.1 /02

. 2011

Quantitative whole body autoradiography of [pyridinylmethyl-14C]BYI 02960 in male and female rats: Distribution of total radioactivity and elimination from blood, organs and tissues after single oral administration including determination of radioactivity in the excreta and exhaled 14CO2 Bayer CropScience, Report No.: MEF-11/276, Edition Number: M-409993-01-2 EPA MRID No.: 48844142 Date: 2011-05-30 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 5.1.2 /01

2011

[Furanone-4-14C]BYI 02960 - Absorption, distribution, excretion, and metabolism in the rat Bayer CropScience, Report No.: MEF-11/556, Edition Number: M-421499-01-1 EPA MRID No.: 48844143 Date: 2011-12-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 5.1.2 /02

. 2011

Quantitative whole body autoradiography of [furanone-4-14C]BYI 02960 in male and female rats: Distribution of total radioactivity and elimination from blood, organs and tissues after single oral administration including determination of radioactivity in the excreta and exhaled 14CO2 Bayer CropScience, Report No.: MEF-11/275, Edition Number: M-409859-01-2 EPA MRID No.: 48844144 Date: 2011-05-30 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.1.2 /03

2011

[Furanone-4-14C]BYI 02960 - Metabolism in organs and tissues of male and female rats Bayer CropScience, Report No.: MEF-11/271, Edition Number: M-414034-02-2 EPA MRID No.: 48844145 Date: 2011-09-12 ...Amended: 2012-02-02 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-414034-02-1)

KIIA 5.1.3 /01

2011

[Ethyl-1-14C]BYI 02960 - Absorption, distribution, excretion, and metabolism in male rats Bayer CropScience, Report No.: MEF-11/555, Edition Number: M-415647-01-1 EPA MRID No.: 48844146 Date: 2011-10-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 5.1.3 /02

2011

[Ethyl-1-14C]BYI 02960 - Metabolism in organs and tissues of male and female rats (3 time-points) Bayer CropScience, Report No.: MEF-11/270, Edition Number: M-415416-02-1 EPA MRID No.: 48844147 Date: 2011-09-29 ...Amended: 2012-02-02 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 5.2.1 /01

2009

BYI 02960 - Acute toxicity in the rat after oral administration Bayer CropScience, Report No.: AT05287, Edition Number: M-349992-01-2 EPA MRID No.: 48844101 Date: 2009-06-08 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-349992-01-1)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.2.2 /01

2009

BYI 02960 - Acute toxicity in the rat after dermal administration Bayer CropScience, Report No.: AT05288, Edition Number: M-349995-01-2 EPA MRID No.: 48844104 Date: 2009-06-08 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-349995-01-1)

KIIA 5.2.3 /01

. 2010

BYI 02960 - Activity ID TXRVP033 - Acute inhalation toxicity in rats Bayer CropScience, Report No.: AT05727, Edition Number: M-362791-01-2 EPA MRID No.: 48844105 Date: 2010-01-07 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-362791-01-1)

KIIA 5.2.4 /01

. 2009

BYI 02960 - Acute skin irritation/corrosion on rabbits Bayer CropScience, Report No.: AT05342, Edition Number: M-353761-01-2 EPA MRID No.: 48844107 Date: 2009-07-08 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-353761-01-1)

KIIA 5.2.5 /01

. 2009

BYI 02960 - Acute eye irritation on rabbits Bayer CropScience, Report No.: AT05341 A, Edition Number: M-361319-02-2 EPA MRID No.: 48844106 Date: 2009-07-08 ...Amended: 2009-10-29 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-361319-02-1)

KIIA 5.2.6 /01

. 2009

BYI 02960 - Local lymph node assay in mice (LLNA/IMDS) Bayer CropScience, Report No.: AT05334, Edition Number: M-353715-01-2 EPA MRID No.: 48844108 Date: 2009-06-29 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-353715-01-1)












Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.3.1 /01

. 2007

BYI 02960 - Exploratory 28-day toxicity study in the rat by gavage Bayer CropScience, Report No.: SA 06075, Edition Number: M-283421-02-2 EPA MRID No.: 48844149 Date: 2007-02-02 ...Amended: 2009-02-24 GLP/GEP: no, unpublished


20120484 TGEURAP

2012-05-08 (M-283421-02-1)

KIIA 5.3.1 /02

2008

BYI 02960 - Exploratory 28-day toxicity study in the rat by dietary administration Bayer CropScience, Report No.: SA 07047, Edition Number: M-297120-01-2 EPA MRID No.: 48844150 Date: 2008-02-01 GLP/GEP: no, unpublished


20120484 TGEURAP

2012-05-08 (M-297120-01-1)

KIIA 5.3.1 /03

2007

BYI 02960 : Preliminary 28-day toxicity study in the mouse by dietary administration Bayer CropScience, Report No.: SA 07013, Edition Number: M-294820-01-2 EPA MRID No.: 48844151 Date: 2007-11-23 GLP/GEP: no, unpublished


20120484 TGEURAP

2012-05-08 (M-294820-01-1)

KIIA 5.3.1 /04

2008

Preliminary 28-day toxicity study in the dog by dietary administration Bayer CropScience, Report No.: SA07290, Edition Number: M-312461-01-3 EPA MRID No.: 48844152 Date: 2008-12-09 GLP/GEP: no, unpublished


20120484 TGEURAP

2012-05-08 (M-312461-01-1)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.3.2 /01

2009

BYI 02960 - 90-day toxicity study in the rat by dietary administration - Amendment no.2 Bayer CropScience, Report No.: SA 07294, Edition Number: M-329048-03-2 EPA MRID No.: 48844111 Date: 2009-02-10 ...Amended: 2012-03-21 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-329048-03-1)

KIIA 5.3.2 /02

2009

BYI 02960 - 90-day toxicity study in the mouse by dietary administration - Amendment no.2 Bayer CropScience, Report No.: SA 07295, Edition Number: M-328668-03-2 EPA MRID No.: 48844112 Date: 2009-02-06 ...Amended: 2012-03-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-328668-03-1)

KIIA 5.3.3 /01

2010

A 90-day toxicity feeding study in the beagle dog with technical grade BYi 02960 Bayer CropScience, Report No.: 09-S76-QQ, Edition Number: M-369978-01-2 EPA MRID No.: 48844114 Date: 2010-04-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-369978-01-1)

KIIA 5.3.4 /01

. 2012

A chronic toxicity feeding study in the Beagle dog with technical grade BYI 02960 - Amended final report - amendment 1 Bayer CropScience, Report No.: 09-C76-RZ, Edition Number: M-425272-02-1 Date: 2012-02-17 ...Amended: 2013-04-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-425272-01-1) 2013-08-30 (M-425272-02-1)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.3.7 /01

. 2012

A subacute dermal toxicity study in rats with BYI 02960 Bayer CropScience, Report No.: 11-S22-US, Edition Number: M-432336-01-1 EPA MRID No.: 48844115 Date: 2012-06-05 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 5.4.1 /01

. 2009

BYI 02960 (tested as BYI 02960 technical) (project: BYI 02960) - Salmonella/microsome test plate incorporation and preincubation method Bayer CropScience, Report No.: AT05387, Edition Number: M-354173-01-2 EPA MRID No.: 48844124 Date: 2009-07-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-354173-01-1)

KIIA 5.4.1 /02

. 2011

1st amendment to report Salmonella typhimurium reverse mutation assay with BYI 02960 Bayer CropScience, Report No.: 1425802, Edition Number: M-420539-02-2 EPA MRID No.: 48844125 Date: 2011-09-23 ...Amended: 2011-10-17 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-420539-02-1)

KIIA 5.4.2 /01

. 2009

BYI 02960 (tested as BYI 02960 technical) - In vitro chromosome aberration test with chinese hamster V79 cells Bayer CropScience, Report No.: AT05626, Edition Number: M-359746-01-2 EPA MRID No.: 48844131 Date: 2009-11-11 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-359746-01-1)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.4.3 /01

2009

BYI 02960 (tested as BYI 02960 technical) (project: BYI 02960) - V79/HPRT test in vitro for the detection of induced forward mutations Bayer CropScience, Report No.: AT05625, Edition Number: M-359743-01-2 EPA MRID No.: 48844128 Date: 2009-10-29 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-359743-01-1)

KIIA 5.4.4 /01

2009

BYI 02960 - Micronucleus-test on the male mouse Bayer CropScience, Report No.: AT05350, Edition Number: M-353785-01-2 EPA MRID No.: 48844134 Date: 2009-07-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-353785-01-1)

KIIA 5.4.4 /02

2011

Micronucleus assay in bone marrow cells of the mouse with BYI 02960-a.i. Bayer CropScience, Report No.: 1425801, Edition Number: M-420536-01-2 EPA MRID No.: 48844135 Date: 2011-11-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-420536-01-1)

KIIA 5.5.2 /01

2012

BYI 02960 - Chronic toxicity and carcinogenicity study in the Wistar rat by dietary administration Bayer CropScience, Report No.: SA 08337, Edition Number: M-428257-01-1 EPA MRID No.: 48844123 Date: 2012-03-05 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.5.3 /01

2012

BYI 02960 - Carcinogenicity study in the C57BL/6J mouse by dietary administration Bayer CropScience, Report No.: SA 08338, Edition Number: M-425975-01-1 EPA MRID No.: 48844122 Date: 2012-02-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 5.6.1 /01

2010

Technical grade BYI 02960: A dose range-finding reproductive toxicity study in the Wistar rat Report No.: 09-P72-RB, Edition Number: M-394208-01-2 EPA MRID No.: 48844120 Date: 2010-11-01 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-394208-01-1)

KIIA 5.6.1 /02

2011

Technical grade BYF 02960: A two-generation reproductive toxicity study in the Wistar rat Bayer CropScience, Report No.: 09-R72-SA, Edition Number: M-417665-01-2 EPA MRID No.: 48844119 Date: 2011-10-17 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-417665-01-1)

KIIA 5.6.10 /01

2010

BYI 02960: Developmental toxicity study in the rat by gavage Bayer CropScience, Report No.: SA 08347, Edition Number: M-363938-01-2 EPA MRID No.: 48844116 Date: 2010-02-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-363938-01-1)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.6.10 /02

2012

BYI 02960 - Complementary maternal tolerability study in the pregnant Sprague-Dawley rat by gavage Bayer CropScience, Report No.: SA 11140, Edition Number: M-425810-01-2 EPA MRID No.: 48844118 Date: 2012-02-21 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-425810-01-1)

KIIA 5.6.11 /01

2012

BYI 02960 - Developmental toxicity study in the rabbit by gavage Bayer CropScience, Report No.: SA 10314, Edition Number: M-423559-01-1 EPA MRID No.: 48844117 Date: 2012-01-26 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 5.7.1 /01

2011

BYI 02960 - An acute neurotoxicity study in the rat by oral administration Bayer CropScience, Report No.: SA 10096, Edition Number: M-415408-01-4 Date: 2011-09-30 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-415408-01-1) 2013-08-30 (M-415408-01-4)

KIIA 5.7.4 /01

2011

BYI 02960 - A 90-day neurotoxicity study in the rat by dietary administration Bayer CropScience, Report No.: SA 09283, Edition Number: M-410022-01-2 EPA MRID No.: 48844139 Date: 2011-06-28 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-410022-01-1)

KIIA 5.7.5 /01

2012

A developmental neurotoxicity study with technical grade BYI 02960 in Wistar rats Report No.: 11-D72-UW, Edition Number: M-434203-01-1 EPA MRID No.: 48844140 Date: 2012-07-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12












Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.8 /01

2010

First amendment to report - Salmonella typhimurium reverse mutation assay with BCS-AA56716 (metabolite of BYI 02960) Bayer CropScience, Report No.: 1351101, Edition Number: M-409724-02-1 Date: 2010-09-30 ...Amended: 2013-03-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-409724-01-1) 2013-08-30 (M-409724-02-1)

KIIA 5.8 /02

2010

BCS-AA56716 (metabolite of BYI 02960) - In vitro chromosome aberration test in Chinese hamster V79 cells Bayer CropScience, Report No.: 1351103, Edition Number: M-409726-01-2 EPA MRID No.: 48844132 Date: 2010-12-15 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-409726-01-1)

KIIA 5.8 /03

2010

First amendment to report - BCS-AA56716 (metabolite of BYI 02960) - Gene mutation assay in Chinese hamster V79 cells in vitro (V79 / HPRT) Bayer CropScience, Report No.: 1351102, Edition Number: M-409727-02-1 Date: 2010-12-20 ...Amended: 2013-03-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-409727-01-1) 2013-08-30 (M-409727-02-1)

KIIA 5.8 /04

2010

BCS-AA56716 - Acute oral toxicity in rats - Acute toxic class method Bayer CropScience, Report No.: 37066 TAR, Edition Number: M-393372-01-2 EPA MRID No.: 48844102 Date: 2010-10-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-393372-01-1)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.8 /05

2011

BCS-AA56716 (difluoroacetic acid): Preliminary 14-day toxicity study in the rat by dietary administration Bayer CropScience, Report No.: SA 10323, Edition Number: M-414152-01-2 EPA MRID No.: 48844153 Date: 2011-09-19 GLP/GEP: no, unpublished


20120484 TGEURAP

2012-05-08 (M-414152-01-1)

KIIA 5.8 /06

2012

BCS-AA56716 (Difluoroacetic acid) - 90-day toxicity study in the rat by dietary administration Bayer CropScience, Report No.: SA 10324, Edition Number: M-424611-01-2 EPA MRID No.: 48844113 Date: 2012-02-02 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-424611-01-1)

KIIA 5.8 /07

2011

Salmonella typhimurium reverse mutation assay with BYI 02960-difluoroethyl-amino-furanone (metabolite of byi-02960) Bayer CropScience, Report No.: 1399701, Edition Number: M-409728-01-2 EPA MRID No.: 48844127 Date: 2011-05-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-409728-01-1)

KIIA 5.8 /08

2010

BYI 02960-difluoroethyl-amino-furanone (metabolite of BYI 02960) - In vitro chromosome aberration test in Chinese hamster V79 cells Bayer CropScience, Report No.: 1399703, Edition Number: M-420108-01-2 EPA MRID No.: 48844133 Date: 2010-10-07 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-420108-01-1)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.8 /09

2010

BYI 0960-difluoroethyl-amino-furanone (metabolite of BYI 02960) - Gene mutation assay in Chinese hamster V79 cells in vitro (V79 / HPRT) Harlan Cytotest Cell Research GmbH (Harlan CCR), , Report No.: 1399702, Edition Number: M-420095-01-2 EPA MRID No.: 48844130 Date: 2010-12-20 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-420095-01-1)

KIIA 5.8 /10

2011

Micronucleus assay in bone marrow cells of the mouse with BYI 02960-difluoroethyl-aminofuranone (metabolite of BYI 02960) Bayer CropScience, Report No.: M-420540-01-2, Edition Number: M-420540-01-2 EPA MRID No.: 48844136 Date: 2011-11-28 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-420540-01-1)

KIIA 5.8 /11

2011

In vivo unscheduled DNA synthesis in rat hepatocytes with BYI 02960-difluoroethyl-amino-furanone (metabolite of BYI 02960) Bayer CropScience, Report No.: 1421402, Edition Number: M-420111-01-2 EPA MRID No.: 48844137 Date: 2011-10-26 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-420111-01-1)

KIIA 5.8 /12

2011

BYI-02960-difluoroethyl-amino-furanone acute oral toxicity in rats acute toxic class method Report No.: 37503 TAR, Edition Number: M-409674-01-2 EPA MRID No.: 48844103 Date: 2011-05-19 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-409674-01-1)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.8 /13

2012

BYI 02960-difluoroethyl aminofuranone: A 14-day dose range finding toxicity/palatability study in rats Report No.: 11/116-100PE, Edition Number: M-426158-01-2 EPA MRID No.: 48844109 Date: 2012-02-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-426158-01-1)

KIIA 5.8 /14

2012

BYI 02960-difluoroethyl aminofuranone: A 28-day dietary toxicity study in wistar rats , Report No.: 11/116-100P, Edition Number: M-426136-01-2 EPA MRID No.: 48844110 Date: 2012-02-29 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-426136-01-1)

KIIA 5.8 /15

Nobuo, M.; Yukihiro, K.

1997

Reverse mutation study on bacteria IM-0 Nippon Soda, Report No.: G-949, Report includes Trial Nos.: 9862 Edition Number: M-195904-01-2 EPA MRID No.: 44988432 Date: 1997-09-30 GLP/GEP: yes, unpublished

Yes Y Nippon Soda 20120484 TGEURAP

2012-05-08 (M-195904-01-1)

KIIA 5.8 /16

1997

Acute oral toxicity study in rats IM-0 Nippon Soda, Report No.: G-0887, Report includes Trial Nos.: 3662 Edition Number: M-195899-01-2 EPA MRID No.: 44988421 Date: 1997-09-30 GLP/GEP: yes, unpublished


2012-05-08 (M-195899-01-1)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.8 /17

1997

Thirteen-week dietary subchronic toxicity study in rats IM-0 , Report No.: G-0889, Report includes Trial Nos.: 0259 Edition Number: M-195901-01-2 EPA MRID No.: 44988427 Date: 1997-11-28 GLP/GEP: yes, unpublished


2012-05-08 (M-195901-01-1)

KIIA 5.8 /18

1997

Reverse mutation study on bacteria IC-0 Nippon Soda Co., Ltd., Odawara Reseach Center, Japan Nippon Soda, Report No.: G-942, Report includes Trial Nos.: 9854 Edition Number: M-195932-01-2 EPA MRID No.: 44988502 Date: 1997-09-30 GLP/GEP: yes, unpublished


2012-05-08 (M-195932-01-1)

KIIA 5.8 /19

1997

Acute oral toxicity study in rats IC-0 Nippon Soda, Report No.: G-0941, Report includes Trial Nos.: 3686 Edition Number: M-195930-01-2 EPA MRID No.: 44988420 Date: 1997-09-30 GLP/GEP: yes, unpublished


2012-05-08 (M-195930-01-1)

KIIA 5.10 /01

2010

BYI 02960 - Biokinetic in the plasma of rats following 7 days exposure through the diet Bayer CropScience, Report No.: SA 09334, Edition Number: M-385777-01-2 EPA MRID No.: 48844154 Date: 2010-07-08 GLP/GEP: no, unpublished


20120484 TGEURAP

2012-05-08 (M-385777-01-1)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 5.10 /02

. 2011

BYI 02960: 28-day immunotoxicity study in the female wistar rat by dietary administration Bayer CropScience, Report No.: SA 10353, Edition Number: M-414754-01-2 EPA MRID No.: 48844148 Date: 2011-09-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-414754-01-1)

KIIA 6.1.1 /01

Netzband, D.; Timberlake, B. C.; Harbin, A. M.

2012

Storage stability of BYI 02960, difluoroacetic acid, and difluoroethyl-amino-furanone in plant matrices (18-month data) , Report No.: RARVP046-1, Edition Number: M-428412-02-1 EPA MRID No.: 48977401 Date: 2012-04-03 ...Amended: 2012-11-01 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-428412-01-1)

KIIA 6.1.1 /02

2012

BYI 02960 - Magnitude of the residue in dairy cows - Amended report , Report No.: RARVP050-1, Edition Number: M-428416-02-1 EPA MRID No.: 48843842 Date: 2012-04-03 ...Amended: 2012-05-31 GLP/GEP: yes, unpublished ...also filed: KIIA 4.3 /08 ...also filed: KIIA 6.4.2 /01


20120484 TGEURAP

2012-05-08 (M-428416-01-1)

KIIA 6.2.1 /01

Justus, K. 2011

Metabolism of [furanone-4-14C]BYI 02960 in tomatoes Bayer CropScience, Report No.: MEF-11/016, Edition Number: M-411352-01-3 EPA MRID No.: 48843801 Date: 2011-07-25 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-411352-01-2)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.2.1 /02

Justus, K. 2011

Metabolism of [pyridinylmethyl-14C]BYI 02960 in tomatoes Bayer CropScience, Report No.: MEF-11/182, Edition Number: M-411500-01-2 EPA MRID No.: 48843802 Date: 2011-07-26 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.2.1 /03

Unold, M.; Justus, K

2011

Metabolism of [ethyl-1-14C]BYI 02960 in tomatoes Bayer CropScience, Report No.: MEF-11/498, Edition Number: M-413996-01-2 EPA MRID No.: 48843803 Date: 2011-09-05 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.2.1 /04

Justus, K. 2011

Metabolism of [furanone-4-14C]BYI 02960 in potatoes Bayer CropScience, Report No.: MEF-10/769, Edition Number: M-415234-01-2 EPA MRID No.: 48843804 Date: 2011-09-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.2.1 /05

Justus, K. 2011

Metabolism of [pyridinylmethyl-14C]BYI 02960 in potatoes Bayer CropScience, Report No.: MEF-10/710, Edition Number: M-415078-01-2 EPA MRID No.: 48843805 Date: 2011-09-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.2.1 /06

Justus, K. 2011

Metabolism of [furanone-4-14C]BYI 02960 in apples Bayer CropScience, Report No.: MEF-11/499, Edition Number: M-422562-01-1 EPA MRID No.: 48843806 Date: 2011-12-29 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08












Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.2.1 /07

Justus, K. 2011

Metabolism of [pyridinylmethyl-14C]BYI 02960 in apples Bayer CropScience, Report No.: MEF-11/198, Edition Number: M-414678-01-2 EPA MRID No.: 48843807 Date: 2011-09-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.2.1 /08

Schmeling, S.; Weber, E.

2011

Metabolism of [furanone-4-14C]BYI 02960 in cotton after spray application Bayer CropScience, Report No.: MEF-11/392, Edition Number: M-421625-01-2 EPA MRID No.: 48843808 Date: 2011-12-12 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.2.1 /09


2011

Metabolism of [pyridinylmethyl-14C]BYI 02960 in cotton after spray application Bayer CropScience, Report No.: MEF-11/393, Edition Number: M-421691-01-2 EPA MRID No.: 48843809 Date: 2011-12-12 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.2.1 /10


2011

Metabolism of [furanone-4-14C]BYI 02960 in paddy rice Bayer CropScience, Report No.: MEF-11/058, Edition Number: M-414219-01-2 EPA MRID No.: 48843810 Date: 2011-09-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.2.1 /11


2011

Metabolism of [pyridinylmethyl-14C]BYI 02960 in paddy rice Bayer CropScience, Report No.: MEF-11/059, Edition Number: M-414328-01-2 EPA MRID No.: 48843811 Date: 2011-09-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.2.1 /12

Schoening, R.; Ruhl, S.

2012

Determination of residues of difluoroacetic acid in extracts of samples from plant metabolism and confined rotational crops studies after application of BYI 02960 Bayer CropScience, Report No.: MR-11/050, Edition Number: M-422550-01-1 EPA MRID No.: 48843812 Date: 2012-01-17 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.2.2 /01

2012

[Pyridinylmethyl-14C]BYI 02960: Metabolism in the laying hen Bayer CropScience, Report No.: MEF-11/199, Edition Number: M-422162-01-2 EPA MRID No.: 48843814 Date: 2012-01-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.2.2 /02

. 2012

[Furanone-4-14C]BYI 02960: Metabolism in the laying hen Bayer CropScience, Report No.: MEF-11/200, Edition Number: M-422263-01-2 EPA MRID No.: 48843813 Date: 2012-01-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.2.3 /01

2011

[Pyridinylmethyl-14C]BYI 02960: Metabolism in the lactating goat Bayer CropScience, Report No.: MEF-11/269, Edition Number: M-419701-01-2 EPA MRID No.: 48843816 Date: 2011-12-07 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.2.3 /02

2011

[Furanone-4-14C]BYI 02960: Metabolism in the lactating goat Bayer CropScience, Report No.: MEF11/268, Edition Number: M-421995-01-2 EPA MRID No.: 48843815 Date: 2011-12-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.3.1.1 /01

Noss, G.; Bauer, J.

2012

Determination of the residues of BYI 02960 in/on lettuce after spraying of BYI 02960 SL 200 in the field in the Netherlands, Belgium, France (North) and Germany Bayer CropScience, Report No.: 10-2223, Report includes Trial Nos.: 10-2223-01 10-2223-02 10-2223-03 10-2223-04 10-2223-05 Edition Number: M-424742-01-1 Date: 2012-02-08 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.1.1 /02

Uceda, L. 2012

Amendment No. 1 - Determination of the residues of BYI 02960 in/on lettuce after spray application of BYI 02960 SL 200 in the field in Germany, northern France and Belgium Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 11-2082, Report includes Trial Nos.: 11-2082-01 11-2082-02 11-2082-03 11-2082-04 Edition Number: M-425941-02-1 Date: 2012-02-23 ...Amended: 2012-03-05 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.3.1.1 /03

Schoening, R.; Bauer, J.

2011

Determination of the residues of BYI 02960 in/on lettuce, head after spray application of BYI 02960 SL 200 in the field in France (South), Spain and Italy - Amendment no. 0001 to report no. 10-2213 Bayer CropScience, Report No.: 10-2213, Report includes Trial Nos.: 10-2213-01 10-2213-02 10-2213-03 10-2213-04 10-2213-05 Edition Number: M-425913-02-1 Date: 2011-09-14 ...Amended: 2012-02-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.1.1 /04

Uceda, L. 2012

Amendment No.1 - Determination of the residues of BYI 02960 in/on lettuce after spray application of BYI 02960 SL 200 in the field in Spain, Italy, Southern France and Portugal Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 11-2071, Report includes Trial Nos.: 11-2071-01 11-2071-02 11-2071-03 11-2071-04 Edition Number: M-425784-02-1 Date: 2012-02-23 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.3.1.1 /05

Schulte, G. 2012

Determination of the residues of BYI 02960 in/on lettuce after spraying of BYI 02960 SL 200 in the greenhouse in France (North), Germany, the Netherlands and Italy Bayer CropScience, Report No.: 10-2212, Report includes Trial Nos.: 10-2212-01 10-2212-02 10-2212-03 10-2212-04 10-2212-05 Edition Number: M-425829-01-1 Date: 2012-02-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.1.1 /06

Uceda, L. 2012

Determination of the residues of BYI 02960 in/on lettuce after spray application of BYI 02960 SL 200 in the greenhouse in northern France, Italy, Spain and Germany Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 11-2070, Report includes Trial Nos.: 11-2070-01 11-2070-02 11-2070-03 11-2070-04 Edition Number: M-425786-01-1 Date: 2012-02-23 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.3.1.2 /01

Noss, G.; Ballmann, C.

2012

Determination of the residues of BYI 02960 in/on hop after spraying of BYI 02960 SL 200 in the field in Germany Bayer CropScience, Report No.: 10-2225, Report includes Trial Nos.: 10-2225-01 10-2225-02 10-2225-03 10-2225-04 Edition Number: M-425351-01-1 Date: 2012-02-13 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.3.1.2 /02

Noss, G.; Ballmann, C.

2012

Determination of the residues of BYI 02960 in/on hop after spray application of BYI 02960 SL 200 in Germany Bayer CropScience, Report No.: 11-2076, Report includes Trial Nos.: 11-2076-01 11-2076-02 11-2076-03 11-2076-04 Edition Number: M-425339-01-1 Date: 2012-02-13 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.1.3 /01

Bauer, J.; Schulte, G.

2012

Determination of the residues of BYI 02960 in/on apple after spraying of BYI 02960 SL 200 in the field in Germany, France (north), the Netherlands and Belgium Bayer CropScience, Report No.: 10-2171, Report includes Trial Nos.: 10-2171-01 10-2171-02 10-2171-03 10-2171-04 10-2171-05 10-2171-06 Edition Number: M-434587-01-1 Date: 2012-07-05 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.1.3 /02


2012

Determination of the residues of BYI 02960 in/on apple after spray application of BYI 02960 SL 200 in the field in Germany, northern France and the United Kingdom Bayer CropScience, Report No.: 11-2077, Report includes Trial Nos.: 11-2077-01 11-2077-02 11-2077-03 11-2077-04 Edition Number: M-438329-01-1 Date: 2012-09-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.1.3 /03

Bauer, J.; Schulte, G.

2012

Determination of the residues of BYI 02960 in/on apple after spraying of BYI 02960 SL 200 in the field in France (south), Italy and Spain Bayer CropScience, Report No.: 10-2172, Report includes Trial Nos.: 10-2172-01 10-2172-02 10-2172-03 10-2172-04 10-2172-05 10-2172-06 Edition Number: M-434603-01-1 Date: 2012-07-05 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.1.3 /04

Schulte, G.; Bauer, J.; Ruhl, S.

2012

Determination of the residues of BYI 02960 in/on apple after spray application of BYI 02960 SL 200 in the field in southern France, Spain, Italy and Portugal Bayer CropScience, Report No.: 11-2078, Report includes Trial Nos.: 11-2078-01 11-2078-02 11-2078-03 11-2078-04 Edition Number: M-439845-01-1 Date: 2012-10-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.1.4 /01

Rosati, D.; Ratajczak, M.

2012

Determination of the residues of BYI 02960 in/on grape after spraying and spraying, low-volume of BYI 02960 SL 200 in the field in Germany, France (North) and Belgium Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 10-2218, Report includes Trial Nos.: 10-2218-01 10-2218-02 10-2218-03 10-2218-04 10-2218-05 Edition Number: M-437138-01-1 Date: 2012-08-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.1.4 /02

Meilland-Berthier, I.

2012

Determination of the residues of BYI 02960 in/on grape after high or low-volume spray application of BYI 02960 SL 200 in Germany and northern France Bayer CropScience, Report No.: 11-2089, Report includes Trial Nos.: 11-2089-01 11-2089-02 11-2089-03 11-2089-04 Edition Number: M-436857-01-1 Date: 2012-08-17 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.1.4 /03

Rosati, D.; Ratajczak, M.

2012

Determination of the residues of BYI 02960 in/on grape after spraying and spraying, low-volume of BYI 02960 SL 200 in the field in France (South), Spain and Italy Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 10-2219, Report includes Trial Nos.: 10-2219-01 10-2219-02 10-2219-03 10-2219-04 Edition Number: M-437131-01-1 Date: 2012-08-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.1.4 /04


2012

Determination of the residues of BYI 02960 in/on grape after high or low-volume spray application of BYI 02960 SL 200 in Southern France, Spain and Italy Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 11-2090, Report includes Trial Nos.: 11-2090-01 11-2090-02 11-2090-03 11-2090-04 Edition Number: M-438482-01-1 Date: 2012-09-18 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.1.5 /01


2012

Determination of the residues of BYI 02960 in/on tomato after spraying of BYI 02960 SL 200 in the field in France (south), Italy, Spain and Portugal Bayer CropScience, Report No.: 10-2186, Report includes Trial Nos.: 10-2186-01 10-2186-02 10-2186-03 10-2186-04 Edition Number: M-438184-01-1 Date: 2012-09-06 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.1.5 /02


2012

Determination of the residues of BYI 02960 in/on tomato after spray application of BYI 02960 SL 200 in the field in Spain, Italy, Portugal and Greece Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 11-2087, Report includes Trial Nos.: 11-2087-01 11-2087-02 11-2087-03 11-2087-04 Edition Number: M-438275-01-1 Date: 2012-01-17 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.1.5 /03

Schoening, R.; Ballmann; C.

2012

Determination of the residues of BYI 02960 in/on tomato after spray application of BYI 02960 SL 200 in the greenhouse in Germany, the Netherlands, France (North) and Belgium Bayer CropScience, Report No.: 10-2190, Report includes Trial Nos.: 10-2190-01 10-2190-02 10-2190-03 10-2190-04 Edition Number: M-426300-01-1 Date: 2012-03-01 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.1.5 /04


2012

Determination of the residues of BYI 02960 in/on tomato and cherry tomato after spray application of BYI 02960 SL 200 in the greenhouse in Germany, the Netherlands, Italy and Spain Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 11-2085, Report includes Trial Nos.: 11-2085-01 11-2085-02 11-2085-03 11-2085-04 Edition Number: M-427056-01-1 Date: 2012-03-08 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.1.3.6 /01

Schulte, G. 2012

Determination of the residues of BYI 02960 in/on sweet pepper after spraying of BYI 02960 SL 200 in the field in France (south), Italy, Spain and Portugal Bayer CropScience, Report No.: 10-2187, Report includes Trial Nos.: 10-2187-01 10-2187-02 10-2187-03 10-2187-04 Edition Number: M-439089-01-1 Date: 2012-09-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.1.3.6 /02

Schulte, G. 2012

Determination of the residues of BYI 02960 in/on sweet pepper after spray application of BYI 02960 SL 200 in the field in southern France, Spain and Italy Bayer CropScience, Report No.: 11-2083, Report includes Trial Nos.: 11-2083-01 11-2083-02 11-2083-03 11-2083-04 Edition Number: M-439083-01-1 Date: 2012-09-25 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.1.3.6 /03

Fargeix, G. 2012

Determination of the residues of BYI 02960 in/on sweet pepper after spraying of BYI 02960 SL 200 in the greenhouse in France, Spain, Italy, Greece and the Netherlands Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 11-2081, Report includes Trial Nos.: 11-2081-01 11-2081-02 11-2081-03 11-2081-04 11-2081-05 11-2081-06 11-2081-07 11-2081-08 Edition Number: M-436855-01-1 Date: 2012-08-17 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.1.3.7 /01

Schulte, G.; Ruhl, S.

2012

Determination of the residues of BYI 02960 in/on cucumber after spraying of BYI 02960 SL 200 in the field in France (south), Spain and Italy Bayer CropScience, Report No.: 10-2184, Report includes Trial Nos.: 10-2184-01 10-2184-02 10-2184-03 10-2184-04 Edition Number: M-438188-01-1 Date: 2012-09-06 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.1.3.7 /02

Schulte, G.; Diehl, P.

2012

Determination of the residues of BYI 02960 in/on gherkin after spray application of BYI 02960 SL 200 in the field in southern France, Spain and Italy Bayer CropScience, Report No.: 11-2066, Report includes Trial Nos.: 11-2066-01 11-2066-02 11-2066-03 11-2066-04 Edition Number: M-438326-01-1 Date: 2012-09-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.1.3.7 /03

Schoening, R.; Oel, D.

2012

Determination of the residues of BYI 02960 in/on cucumber after spray application of BYI 02960 SL 200 in the greenhouse in France (South), the Netherlands, Germany and Italy Bayer CropScience, Report No.: 10-2189, Report includes Trial Nos.: 10-2189-01 10-2189-02 10-2189-03 10-2189-04 Edition Number: M-435235-01-1 Date: 2012-07-23 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.1.3.7 /04

Schulte, G.; Diehl, P.

2012

Determination of the residues of BYI 02960 in/on cucumber after spray application of BYI 02960 SL 200 in the greenhouse in Greece, Italy, Spain and Portugal Bayer CropScience, Report No.: 11-2067, Report includes Trial Nos.: 11-2067-01 11-2067-02 11-2067-03 11-2067-04 Edition Number: M-439079-01-1 Date: 2012-09-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.1.3.8 /01

Schoening, R.; Ballmann, C.

2012

Determination of the residues of BYI 02960 in/on melon after spray application of BYI 02960 SL 200 in the field in Spain, Italy, France (South) and Portugal Bayer CropScience, Report No.: 10-2185, Report includes Trial Nos.: 10-2185-01 10-2185-02 10-2185-03 10-2185-04 Edition Number: M-439328-01-1 Date: 2012-10-01 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.1.3.8 /02

Fargeix, G. 2012

Determination of the residues of BYI 02960 in/on water melon after spray application of BYI 02960 SL 200 in the field in Portugal, Italy and Spain Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 11-2074, Report includes Trial Nos.: 11-2074-01 11-2074-02 11-2074-03 11-2074-04 11-2074-05 Edition Number: M-438099-01-1 Date: 2012-09-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.1.3.8 /03

Uceda, L. 2012

Determination of the residues of BYI 02960 in/on melon after spray application of BYI 02960 SL 200 in the greenhouse in the Netherlands, Italy and Spain Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 10-2188, Report includes Trial Nos.: 10-2188-01 10-2188-02 10-2188-03 Edition Number: M-425792-01-1 Date: 2012-02-23 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.1.3.8 /04

Fargeix, G. 2012

Determination of the residues of BYI 02960 in/on water melon after spraying application of BYI 02960 SL 200 in the greenhouse in Spain and Italy Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 11-2075, Report includes Trial Nos.: 11-2075-01 11-2075-02 11-2075-03 11-2075-04 11-2075-05 11-2075-06 Edition Number: M-437681-01-1 Date: 2012-09-04 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.1 /01

Beedle, E.; Niczyporowicz, L. M.

2012

BYI 02960 200 SL - Magnitude of the residue in/on citrus (crop group 10) Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY012, Edition Number: M-433259-01-1 EPA MRID No.: 48843913 Date: 2012-06-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.1 /02

Woodard, D. L.; Timberlake, B.

2012

BYI 02960 200 SL - Magnitude of the residue in/on mandarin orange (CG 10) Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVP064, Edition Number: M-432184-01-2 EPA MRID No.: 48843914 Date: 2012-06-05 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.1 /03

Dallstream, K. A.

2012

BYI 02960 200 SL - Magnitude of the residue in/on citrus (including bridging trials to Brazil import tolerance) Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVP076, Edition Number: M-432687-01-1 EPA MRID No.: 48843915 Date: 2012-06-15 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.1 /04

Resende, G.

2012

Amendment 01 to the final report - Determination of residues of BYI 02960 and its metabolites, in citrus culture after drench application at the base of the plants, followed by foliar spray application of BYI 02960 (200 SL) in field trials in Brazil Bayer CropScience, São Paulo, SP, Brazil Bayer CropScience, Report No.: I11-022, Report includes Trial Nos.: I11-022-01 I11-022-02 I11-022-03 I11-022-04 I11-022-05 Edition Number: M-427041-02-3 EPA MRID No.: 48843945 Date: 2012-03-06 ...Amended: 2012-07-11 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.1 /05

Resende, G.

2012

Amendment 01 to the final report - Determination of residues of BYI 02960 and its metabolites, in citrus after foliar spray application of BYI 02960 (200 SL) in field trials in Brazil Departamento de Registro Bayer CropScience, São Paulo, Brazil Bayer CropScience, Report No.: I11-006, Report includes Trial Nos.: I11-006-03 I11-006-04 I11-006-05 I11-006-06 I11-006-07 Edition Number: M-427468-02-3 EPA MRID No.: 48843946 Date: 2012-03-09 ...Amended: 2012-07-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.2 /01

Niczyporowicz, L. M.; Netzband, D.

2012

BYI 02960 200 SL - Magnitude of the residue in/on tree nuts (Crop Group 14) Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY016, Edition Number: M-433350-01-1 EPA MRID No.: 48843920 Date: 2012-06-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.3 /01

Lam, C. 2012

BYI 02960 200 SL - Magnitude of the residue in/on pome fruits (crop group 11) Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY013, Edition Number: M-432703-01-1 EPA MRID No.: 48843916 Date: 2012-06-18 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.4 /01

Dallstream, K. A.

2012

BYI 02960 200 SL - Magnitude of the residue in/on small fruit vine climbing (except Fuzzy kiwifruit) Crop Subgroup 13-07F Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY007, Edition Number: M-432181-01-2 EPA MRID No.: 48843918 Date: 2012-06-04 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12




Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.5 /01

Dorschner, K. W.

2012

BYI 02960: Magnitude of the residue on blueberry Rutgers, The State University of New Jersey, Princeton, NJ, USA TF- BCS-IR4, Report No.: IR-4 PR No. 10637, Report includes Trial Nos.: 10637.11-AU01 10637.11-AU02 10637.11-AU04 10637.11-CL01 10637.11-CL02 10637.11-CL03 10637.11-DK01 10637.11-IT01 10637.11-MI01 10637.11-MI02 10637.11-MI03 10637.11-NC01 10637.11-NC02 10637.11-NJ01 10637.11-NJ02 10637.11-NS01 10637.11-NS02 10637.11-NS03 10637.11-NZ01 10637.11-NZ02 10637.11-OR01 10637.11-QC16 10637.11-SP01 10637.11-UK01 10637.11-UK02 Edition Number: M-435476-01-1 EPA MRID No.: 48843917 Date: 2012-07-17 GLP/GEP: yes, unpublished

Yes Y TF- BCS-IR4 20120484 TGEURAP

2012-11-12




Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.6 /01

Dorschner, K.

1996

BYI 02960: Magnitude of the residue on prickly pear cactus U.S. Department of Agriculture, Salinas, CA, USA TF- BCS-IR4, Report No.: IR-4 PR NO. 10722, Report includes Trial Nos.: 10722.11-CA*01 10722.11-CA*02 10722.11-CA*143 10722.11-CA*144 10722.11-CA*160 10722.11-CA*161 10722.11-CA*162 10722.11-CA*163 Edition Number: M-432542-01-1 EPA MRID No.: 48843931 Date: 1996-10-24 GLP/GEP: yes, unpublished

Yes Y TF- BCS-IR4 20120484 TGEURAP

2012-11-12

KIIA 6.3.2.7 /01

Krolski, M. E.; Harbin, A. M.

2012

BYI 02960 200 SL - Magnitude of the residue in potato - Tuberous and corm vegetables (Crop Subgroup 1C) Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY015, Edition Number: M-430532-01-2 EPA MRID No.: 48843902 Date: 2012-05-08 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.7 /02

Ellis, A. 2011

Amendment no.1 - Determination of residues of BYI 02960 in potatoes and sweet potatoes following two or three applications of BYI 02960 200 SL at rates of 100, 150 or 200 g a.i./ha seven days apart Bayer CropScience Pty. Ltd., Eight Mile Plains, QLD, Australia Bayer CropScience, Report No.: BCS-0352, Edition Number: M-415292-02-1 EPA MRID No.: 48843940 Date: 2011-09-30 ...Amended: 2012-07-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.7 /03

Ellis, A. 2012

Amendment no.1 - Determination of residues of BYI 02960 in potatoes and sweet potatoes following two or three applications of BYI 02960 200 SL at rates of 100, 150 or 200 g a.i./ha seven days apart Bayer CropScience Pty. Ltd., Residue Laboratory, Eight Mile Plains, QLD, Australia Bayer CropScience, Report No.: BCS-0358, Report includes Trial Nos.: C538 C539 C541 C632 Edition Number: M-426841-02-1 EPA MRID No.: 48843941 Date: 2012-02-27 ...Amended: 2012-07-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.8 /01

Miller, A.; Helfrich, K. K.

2012

BYI 02960 200 SL - Magnitude of the residue in/on fruiting vegetables (CG 8); US / Canada import tolerance Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY022, Edition Number: M-433126-01-1 EPA MRID No.: 48843911 Date: 2012-06-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.8 /02

Ellis, A. 2011

Amendment no.1 - Determination of residues of BYI 02960 following three foliar applications of BYI 02960 200 SL to trellis and bush tomatoes at rates of 100, 150 or 200 g a.i./ha seven days apart, and in glass house tomatoes at rates of 10, 15 and 20 g a.i./100L seven days apart Bayer CropScience Pty. Ltd., Residue Laboratory, Eight Mile Plains, QLD, Australia Bayer CropScience, Report No.: BCS-0348.02, Edition Number: M-411773-02-1 EPA MRID No.: 48843936 Date: 2011-07-20 ...Amended: 2012-07-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.8 /03

Ellis, A. 2011

Amendment no. 1 - Determination of residues of BYI 02960 following three foliar applications of BYI 02960 200 SL to capsicums at rates of 100, 150 or 200 g a.i./ha seven days apart Bayer CropScience Pty. Ltd., Residue Laboratory, Eight Mile Plains, QLD, Australia Bayer CropScience, Report No.: BCS-0349.02, Edition Number: M-430274-02-1 EPA MRID No.: 48843937 Date: 2011-08-11 ...Amended: 2012-07-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.8 /04

Ellis, A. 2012

Determination of residues of BYI 02960 following three foliar applications of BYI 02960 200 SL to trellis and bush tomatoes at rates of 100, 150 or 200 g a.i./ha seven days apart, and in glass house tomatoes at rates of 10, 15 and 20 g a.i./ 100 L seven days apart - Amendment no. 1 to the report BCS-0354 Bayer CropScience Pty. Ltd., Residue Laboratory, Eight Mile Plains, QLD, Australia Bayer CropScience, Report No.: BCS-0354, Report includes Trial Nos.: C525 C526 C683 Edition Number: M-433790-02-1 EPA MRID No.: 48843938 Date: 2012-05-31 ...Amended: 2012-07-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.8 /05

Ellis, A. 2012

Determination of residues of BYI 02960 following three foliar applications of BYI 02960 200 SL to capsicums at rates of 100, 150 or 200 g a.i./ha seven days apart - Amendment no. 1 to the report BCS-0355 Bayer CropScience Pty. Ltd., Residue Laboratory, Eight Mile Plains, QLD, Australia Bayer CropScience, Report No.: BCS-0355, Edition Number: M-432144-02-1 EPA MRID No.: 48843939 Date: 2012-05-11 ...Amended: 2012-07-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.9 /01

Netzband, D.; Niczyporowicz, L. M.

2012

BYI 02960 SL 200 - Magnitude of the residue in/on leafy vegetables (Crop Group 4) Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY005, Edition Number: M-433317-01-1 EPA MRID No.: 48843904 Date: 2012-06-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.10 /01

Hoag, R. E.; Arthur, E. L.; Woodard, D. L.

2012

BYI 02960 200 SL - Magnitude of the residue in/on dried, shelled pea and bean (except soybean), foliage of legume vegetables (except soybean); (CG 6C and 7A) Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY028, Edition Number: M-433260-01-1 EPA MRID No.: 48843909 Date: 2012-06-26 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.11 /01

Krolski, M. E.; Harbin, A. H.

2012

BYI 02960 200 SL - Magnitude of the residue in peanut Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY010, Edition Number: M-424313-01-2 EPA MRID No.: 48843930 Date: 2012-01-30 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.12 /01

Sturdivant, D. W.

2012

BYI 02960 200 SL and BYI 02960 480 FS - Magnitude of the residue in/on soybeans Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY011, Edition Number: M-431214-01-2 EPA MRID No.: 48843910 Date: 2012-05-15 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.13 /01

Timberlake, B. C.; Harbin, A. M.

2012

BYI 02960 200 SL and BYI 02960 480 FS - Magnitude of the residue in/on cotton (Crop Subgroup 20C) Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY009, Edition Number: M-431910-01-2 EPA MRID No.: 48843925 Date: 2012-06-01 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.14 /01

Hoag, R. E. 2012

BYI 02960 200 SL and BYI 02960 480 FS - Magnitude of the residue in/on barley Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY001, Edition Number: M-431905-01-2 EPA MRID No.: 48843921 Date: 2012-04-19 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.15 /01

Fisher, D. R.

2012

BYI 02960 200 SL and BYI 02960 480 FS - Magnitude of the residue in/on corn Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY002, Edition Number: M-432754-01-1 EPA MRID No.: 48843922 Date: 2012-06-18 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.16 /01

Krolski, M. E.; Dallstream, K. A.

2012

BYI 02960 200 SL and BYI 02960 480 FS - Magnitude of the residue in/on sorghum Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY004, Edition Number: M-427048-01-2 EPA MRID No.: 48843923 Date: 2012-03-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.17 /01

Fischer, D. R.; Niczyporowicz, L. M.

2012

BYI 02960 200 SL and BYI 02960 480 FS - Magnitude of the residue in/on wheat Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY003, Edition Number: M-433258-01-1 EPA MRID No.: 48843924 Date: 2012-06-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.18 /01

Hoag, R. E. 2012

BYI 02960 200 SL - Magnitude of the residue in/on coffee; U.S., Canada and E.U. import tolerance Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVP074, Edition Number: M-433257-01-1 EPA MRID No.: 48843928 Date: 2012-06-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.3.2.18 /02

Resende, G.

2012

Amendment 01 to the final report - Determination of residues of BYI 02960 and its metabolites, in coffee after drench application at the base of the plants, followed by foliar application of BYI 02960 (200 SL) in field trials in Brazil Departamento de Registro Bayer CropScience, São Paulo, Brazil Bayer CropScience, Report No.: I11-008, Report includes Trial Nos.: I11-008-01 I11-008-02 I11-008-04 I11-008-05 Edition Number: M-427469-03-2 EPA MRID No.: 48843944 Date: 2012-03-09 ...Amended: 2012-07-02 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.3.2.19 /01

Krolski, M. E.

2012

BYI 02960 200 SL - Magnitude of the residue in/on hops Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY008, Report includes Trial Nos.: RV047-11HA RV048-11HA RV049-11HA Edition Number: M-432695-01-1 EPA MRID No.: 48843929 Date: 2012-06-12 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.4.1 /01

2012

BYI 02960 - Magnitude of the residue in laying hens Bayer CropScience, Report No.: RARVP041, Edition Number: M-428933-01-1 Date: 2012-04-05 GLP/GEP: yes, unpublished ...also filed: KIIA 4.3 /09


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.4.2 /01

. 2012

BYI 02960 - Magnitude of the residue in dairy cows - Amended report , Report No.: RARVP050-1, Edition Number: M-428416-02-1 EPA MRID No.: 48843842 Date: 2012-04-03 ...Amended: 2012-05-31 GLP/GEP: yes, unpublished ...also filed: KIIA 4.3 /08 ...also filed: KIIA 6.1.1 /02


20120484 TGEURAP

2012-05-08 (M-428416-01-1)

KIIA 6.5.1 /01

Weber, E. 2011

Nature of the residues of [pyridinylmethyl-14C]BYI02960 in processed commodities - High temperature hydrolysis Bayer CropScience, Report No.: MEF-10/856, Edition Number: M-402311-01-2 EPA MRID No.: 48843966 Date: 2011-02-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-06-25

KIIA 6.5.4 /01


2012

Determination of the residues of BYI 02960 in/on lettuce and head lettuce and the processed fractions (head, inner parts; leaf, outer; leaf, inner; leaf, inner, washed and washings) after spraying of BYI 02960 SL 200 in the field in the Netherlands, Belgium and Germany Bayer CropScience, Report No.: 10-3223, Report includes Trial Nos.: 10-3223-01 10-3223-02 10-3223-04 10-3223-05 Edition Number: M-426982-01-2 EPA MRID No.: 48843947 Date: 2012-03-07 GLP/GEP: yes, unpublished ...also filed: KIIA 6.5.4.1 /01


20120484 TGEURAP

2012-05-08 (M-426982-01-1)








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.5.4 /02


2012

Determination of the residues of BYI 02960 in/on hop (cone, green and cone, kiln-dried) and the processed fractions (hops draff, brewer's yeast and beer) after spraying of BYI 02960 SL 200 in the field in Germany Bayer CropScience, Report No.: 10-3407, Report includes Trial Nos.: 10-3407-01 10-3407-02 Edition Number: M-425311-01-1 Date: 2012-02-13 GLP/GEP: yes, unpublished ...also filed: KIIA 6.5.4.2 /01


20120484 TGEURAP

2012-05-08

KIIA 6.5.4.1 /01


2012

Determination of the residues of BYI 02960 in/on lettuce and head lettuce and the processed fractions (head, inner parts; leaf, outer; leaf, inner; leaf, inner, washed and washings) after spraying of BYI 02960 SL 200 in the field in the Netherlands, Belgium and Germany Bayer CropScience, Report No.: 10-3223, Report includes Trial Nos.: 10-3223-01 10-3223-02 10-3223-04 10-3223-05 Edition Number: M-426982-01-2 EPA MRID No.: 48843947 Date: 2012-03-07 GLP/GEP: yes, unpublished ...also filed: KIIA 6.5.4 /01


20120484 TGEURAP

2012-05-08 (M-426982-01-1)






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.5.4.2 /01


2012

Determination of the residues of BYI 02960 in/on hop (cone, green and cone, kiln-dried) and the processed fractions (hops draff, brewer's yeast and beer) after spraying of BYI 02960 SL 200 in the field in Germany Bayer CropScience, Report No.: 10-3407, Report includes Trial Nos.: 10-3407-01 10-3407-02 Edition Number: M-425311-01-1 Date: 2012-02-13 GLP/GEP: yes, unpublished ...also filed: KIIA 6.5.4 /02


20120484 TGEURAP

2012-05-08

KIIA 6.5.4.3 /01


2012

Processing Study - Determination of the residues of BYI 02960 in/on orange (fruit and pulp) and the processed fractions (fruit, stored; whole fruit, washed; washings; raw juice; pomace, wet; pomace, dried; juice; marmalade; pulp; peel; peel washed; peel without oil; oil) after spraying of BYI 02960 SL 200 in the field in Spain Bayer CropScience, Report No.: 10-3405, Report includes Trial Nos.: 10-3405-01 10-3405-02 Edition Number: M-439410-01-1 Date: 2012-10-01 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.5.4.3 /02

Lenz, C. 2012

BYI 02960 200 SL - Magnitude of the residue in/on orange processed commodities Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY035, Edition Number: M-432186-01-2 EPA MRID No.: 48843954 Date: 2012-06-01 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.5.4.4 /01


2012

Amendment No. 1 - Determination of the residues of BYI 02960 in/on apple and the processed fractions (whole fruit, washed; washings; raw sauce; strain rest; sauce; pomace, wet; pomace, dried; raw juice; juice, retentate; peel; fruit peeled; fruit, dried) after spraying of BYI 02960 SL 200 in the field in Germany and Belgium Bayer CropScience, Report No.: 10-3171, Report includes Trial Nos.: 10-3171-03 10-3171-06 Edition Number: M-434004-02-1 Date: 2012-07-05 ...Amended: 2012-09-28 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.5.4.4 /02

Schulte, G.; Ballmann, C.

2012

Determination of the residues of BYI 02960 in/on apple and the processed fractions (whole fruit, washed; washings; raw sauce; strain rest; sauce; pomace, wet; pomace, dried; raw juice; retentate; and juice) after spray application of BYI 02960 SL 200 in the field in Italy and Spain Bayer CropScience, Report No.: 10-3172, Report includes Trial Nos.: 10-3172-03 10-3172-06 Edition Number: M-434006-01-2 Date: 2012-07-05 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.5.4.5 /01

Noss, G.; Teubner, L.

2012

Determination of the residues of BYI 02960 in/on peach and the processed fractions (whole fruit, washed; washings; peel; fruit, peeled and preserve) after spraying of BYI 02960 SL of BYI 02960 SL 200 in the field in Spain and Italy Bayer CropScience, Report No.: 10-3216, Report includes Trial Nos.: 10-3216-02 10-3216-03 Edition Number: M-439376-01-1 Date: 2012-10-08 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.5.4.6 /01

Noss, G.; Bauer, J.; Ruhl, S.

2011

Determination of the residues of BYI 02960 in/on grape and the processed fractions (pomace, grape; must; wine at bottling; wine at first taste test, juice, pasteurised; jelly; washings; raisin waste; raisin) after spraying of BYI 02960 SL 200 in the field in Germany Bayer CropScience, Report No.: 10-3406, Report includes Trial Nos.: 10-3406-01 10-3406-02 10-3406-03 10-3406-04 Edition Number: M-433545-01-1 EPA MRID No.: 48843953 Date: 2011-09-07 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.5.4.7 /01


2012

Processing study - Determination of the residues of BYI 02960 in/on beet, sugar and processed fractions (body, washed; washings; pulp; raw juice; thin juice; cake, lime; thick juice; molasses; raw sugar; white sugar; pulp, extracted, wet; press liquor; pulp, extracted, pressed; pulp, extracted, dry; pulp, extracted, ensiled; and refined sugar) after spraying and incorporation of BYI 02960 SL 200 in the field in Germany Bayer CropScience, Report No.: 10-3408, Report includes Trial Nos.: 10-3408-01 10-3408-02 Edition Number: M-439824-01-1 Date: 2012-10-18 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.5.4.8 /01

Schulte, G.; Ballmann, C.

2012

Amendment No. 2 - Determination of the residues of BYI 02960 in/on tomato and the processed fractions (whole fruit, washed; washings; strain rest; raw juice; juice; raw puree; puree; paste; peel; peeling water; fruit peeled; preserve and tomato, dried) after spraying of BYI 02960 SL 200 in the field in southern France, Italy, Spain and Portugal Bayer CropScience, Report No.: 10-3186, Report includes Trial Nos.: 10-3186-01 10-3186-02 10-3186-03 10-3186-04 Edition Number: M-427003-03-1 Date: 2012-03-08 ...Amended: 2012-09-28 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.5.4.9 /01


2012

Determination of the residues of BYI 02960 in/on cucumber and the processed fractions (washings; whole fruit, washed; preserve; brine; and fruit, fermented) after spraying of BYI 02960 SL 200 in the field in France (south) - Processing study Bayer CropScience, Report No.: 10-3184, Report includes Trial Nos.: 10-3184-01 10-3184-04 Edition Number: M-438180-01-1 Date: 2012-09-06 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.5.4.10 /01


2012

Processing study - Determination of the residues of BYI 02960 in/on spring barley and the processed fractions (malt sprouts; brewer's malt; brewer's grain, hops draff; brewer's yeast; beer; pearl barley; pearl barley rub off) after spraying of BYI 02960 SL 200 in the field in Germany Bayer CropScience, Report No.: 10-3410, Report includes Trial Nos.: 10-3410-01 10-3410-02 Edition Number: M-439853-01-1 Date: 2012-10-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.5.4.11 /01


2012

Processing study - Determination of the residues of BYI 02960 in/on wheat and the processed fractions (semolina; semolina bran; whiteflour bran; white flour; white bread; whole meal; wholemeal bread and wheat germ) after spraying of BYI 02960 SL 200 in the field in Germany Bayer CropScience, Report No.: 10-3409, Report includes Trial Nos.: 10-3409-01 10-3409-02 Edition Number: M-440307-01-1 Date: 2012-10-30 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.5.4.11 /02

Lenz, C.; Fischer, D. R.

2012

BYI 02960 200 SL - Magnitude of the residue in/on wheat processed commodities Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY031, Edition Number: M-427047-01-2 EPA MRID No.: 48843959 Date: 2012-03-13 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.5.4.12 /01

Hoag, R. E. 2012

BYI 02960 200 SL - Magnitude of the residue in/on processed commodities for coffee; U.S., Canada and E.U. import tolerance Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVP075, Edition Number: M-433200-01-1 EPA MRID No.: 48843950 Date: 2012-06-26 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.5.4.13 /01

Lenz, C. 2012

BYI 02960 200 SL - Magnitude of the residue in/on field corn processed commodities Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY030, Edition Number: M-424774-01-1 EPA MRID No.: 48843951 Date: 2012-02-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.5.4.14 /01

Lenz, C.; Beedle, E.

2012

BYI 02960 200 SL - Magnitude of the residue in cotton processed commodities (crop subgroup 20C) Bayer Corporation, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY033, Edition Number: M-433122-01-1 EPA MRID No.: 48843952 Date: 2012-06-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.5.4.15 /01

Lenz, C. 2012

BYI 02960 200 SL - Magnitude of the residue in/on peanut processed commodities Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY032, Report includes Trial Nos.: RV274-10PA RV275-10PA Edition Number: M-430523-01-2 EPA MRID No.: 48843955 Date: 2012-05-08 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.5.4.16 /01

Lenz, C. 2012

BYI 02960 200 SL - Magnitude of the residue in/on potato processed commodities Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY038, Edition Number: M-430542-01-2 EPA MRID No.: 48843956 Date: 2012-05-07 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.5.4.17 /01

Lenz, C. 2012

BYI 02960 200 SL - Magnitude of the residue in/on soybean processed commodities Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVY029, Report includes Trial Nos.: RV268-10PA RV269-10PA Edition Number: M-428939-01-2 EPA MRID No.: 48843957 Date: 2012-04-04 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.5.4.18 /01

Fischer, D. R.

2012

BYI 02960 200 SL - Request for Waiver of the requirements for the BYI 02960 magnitude of the residue in sugarcane processed commodities in Florida (rotational crop regional tolerance) Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: RARVX001, Report includes Trial Nos.: RV288-10PA Edition Number: M-432700-01-1 EPA MRID No.: 48843960 Date: 2012-06-18 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.6.2 /01

A. Klempner 2011

Metabolism of [furanone-4-14C]BYI 02960 in confined rotational crops Bayer CropScience, Report No.: MEF-11/365, Edition Number: M-421861-01-3 EPA MRID No.: 48843961 Date: 2011-12-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-421861-01-2)








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.6.2 /02

Breuer-Rehm, M.

2011

Metabolism of [pyridinylmethyl-14C]BYI 02960 in confined rotational crops Bayer CropScience, Report No.: MEF-10/892, Edition Number: M-419853-02-1 EPA MRID No.: 48843962 Date: 2011-12-02 ...Amended: 2012-02-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 6.6.3 /01


2012

Determination of the residues of BYI 02960 in/on the field rotational crops barley, carrot, lettuce and turnip after spray application of BYI 02960 SL 200 on lettuce and soil in the field in Germany, the Netherlands, France (South) and Spain Bayer CropScience, Report No.: 10-2503, Report includes Trial Nos.: 10-2503-01 10-2503-02 10-2503-03 10-2503-04 Edition Number: M-429091-02-1 Date: 2012-04-11 ...Amended: 2013-01-24 GLP/GEP: yes, unpublished ...also filed: KIIA 6.6.3.1.1 /01


20120484 TGEURAP

2012-05-08 (M-429091-01-1) 2013-08-30 (M-429091-02-1)






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.6.3.1.1 /01


2012

Determination of the residues of BYI 02960 in/on the field rotational crops barley, carrot, lettuce and turnip after spray application of BYI 02960 SL 200 on lettuce and soil in the field in Germany, the Netherlands, France (South) and Spain Bayer CropScience, Report No.: 10-2503, Report includes Trial Nos.: 10-2503-01 10-2503-02 10-2503-03 10-2503-04 Edition Number: M-429091-02-1 Date: 2012-04-11 ...Amended: 2013-01-24 GLP/GEP: yes, unpublished ...also filed: KIIA 6.6.3 /01


20120484 TGEURAP

2012-05-08 (M-429091-01-1)

KIIA 6.6.3.1.2 /01

Schulte, G. 2012

Determination of the residues of BYI 02960 in/on the field rotational crop potato after spray application of BYI 02960 SL 200 to bare soil in the field in northern France, the Netherlands, Spain and Italy - Limited rotational crop study Bayer CropScience, Report No.: 11-2550, Report includes Trial Nos.: 11-2550-01 11-2550-02 11-2550-03 11-2550-04 Edition Number: M-438341-01-1 Date: 2012-09-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.6.3.1.3 /01

Schulte, G. 2012

Determination of the residues of BYI 02960 in/on the field rotational crop leek after spray application of BYI 02960 SL 200 to bare soil in the field in northern France, Germany, Spain and Italy - Limited rotational crop study Bayer CropScience, Report No.: 11-2551, Report includes Trial Nos.: 11-2551-01 11-2551-02 11-2551-03 11-2551-04 Edition Number: M-438384-01-1 Date: 2012-09-13 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.6.3.1.4 /01

Schulte, G. 2012

Determination of the residues of BYI 02960 in/on the field rotational crop cucumber after spray application of BYI 02960 SL 200 to bare soil in the field in northern France, Germany, Spain and Italy - Limited rotational crop study Bayer CropScience, Report No.: 11-2552, Report includes Trial Nos.: 11-2552-01 11-2552-02 11-2552-03 11-2552-04 Edition Number: M-438343-01-1 Date: 2012-09-13 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.6.3.1.5 /01

Schulte, G. 2012

Determination of the residues of BYI 02960 in/on the field rotational crop onion after spray application of BYI 02960 SL 200 on bare soil in the field in France (North), Germany, Italy and Spain - Limited rotational crop study Bayer CropScience, Report No.: 11-2553, Report includes Trial Nos.: 11-2553-01 11-2553-02 11-2553-03 11-2553-04 Edition Number: M-438397-01-1 Date: 2012-09-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.6.3.1.6 /01

Schulte, G. 2012

Amendment no. 1 to report no: 11.2555 - Determination of the residues of BYI 02960 in/on the field rotational crop french bean after spray application of BYI 02960 SL 200 to bare soil in the field in northern France, Germany, Italy and Spain - Limited rotational crop study Bayer CropScience, Report No.: 11-2555, Report includes Trial Nos.: 11-2555-01 11-2555-02 11-2555-03 11-2555-04 Edition Number: M-438394-02-1 Date: 2012-09-14 ...Amended: 2012-09-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.6.3.1.7 /01

Schulte, G. 2012

Determination of the residues of BYI 02960 in/on the field rotational crop pea after spray application of BYI 02960 SL 200 on bare soil in the field in France (North), Germany, Italy and Spain - Limited rotational crop study Bayer CropScience, Report No.: 11-2556, Report includes Trial Nos.: 11-2556-01 11-2556-02 11-2556-03 11-2556-04 Edition Number: M-438582-01-1 Date: 2012-09-17 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 6.6.3.1.8 /01

Schulte, G. 2012

Determination of the residues of BYI 02960 in/on the field rotational crop rape after spray application of BYI 02960 SL 200 on bare soil in the field in nothern France, Germany, Italy and Spain Bayer CropScience, Report No.: 11-2554, Report includes Trial Nos.: 11-2554-01 11-2554-02 11-2554-03 11-2554-04 Edition Number: M-443092-01-1 Date: 2012-12-07 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 6.6.3.2 /01

Krolski, M. E.; Dallstream, K. A.

2012

BYI 02960, fenamidone, fluopyram, and spiromesifen - Magnitude of the residue in sugarcane in Florida (rotational crop regional Tolerance) Bayer CropScience LP, RTP, NC, USA Bayer CropScience, Report No.: RARVP030, Report includes Trial Nos.: RV001-11RA RV002-11RA RV286-10RA RV287-10RB Edition Number: M-432179-01-2 EPA MRID No.: 48843964 Date: 2012-05-25 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-11-12

KIIA 7.1.1 /01

Menke, U. 2011

[Pyridinylmethyl-14C]BYI 02960: Aerobic soil metabolism/degradation and time-dependent sorption in soils Bayer CropScience, Report No.: MEF-07/334, Edition Number: M-414615-01-2 EPA MRID No.: 48843674 Date: 2011-08-05 GLP/GEP: yes, unpublished ...also filed: KIIA 7.2.1 /01 ...also filed: KIIA 7.4.1 /03


20120484 TGEURAP

2012-05-08

KIIA 7.1.1 /02

Menke, U.; Unold, M.

2011

[Furanone-4-14C]BYI 02960: Aerobic soil metabolism/degradation Bayer CropScience, Report No.: MEF-10/804, Edition Number: M-411625-01-2 EPA MRID No.: 48843676 Date: 2011-07-28 GLP/GEP: yes, unpublished ...also filed: KIIA 7.2.1 /02


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.1.1 /03

Ripperger, R. J.

2011

[Furanone-4-14C]BYI 02960: Aerobic soil metabolism in two US soils Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP037-2, Edition Number: M-405497-03-1 EPA MRID No.: 48843677 Date: 2011-01-14 ...Amended: 2012-01-05 GLP/GEP: yes, unpublished ...also filed: KIIA 7.2.1 /03


20120484 TGEURAP

2012-05-08

KIIA 7.1.1 /04


2011

[Ethyl-1-14C]BYI 02960: Aerobic soil metabolism Bayer CropScience, Report No.: MEF-10/858, Edition Number: M-414981-01-1 EPA MRID No.: 48843679 Date: 2011-09-08 GLP/GEP: yes, unpublished ...also filed: KIIA 7.2.1 /04


20120484 TGEURAP

2012-05-08

KIIA 7.1.1 /05


2011

[Pyridine-2,6-14C]BYI 02960: Aerobic soil metabolism Bayer CropScience, Report No.: MEF-10/880, Edition Number: M-411693-01-2 EPA MRID No.: 48843681 Date: 2011-07-28 GLP/GEP: yes, unpublished ...also filed: KIIA 7.2.1 /05


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.1.1 /06

Shepherd, J. J.

2011

[Pyridine-2,6-14C]BYI 02960: Aerobic soil metabolism in two US soils Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP038-1, Edition Number: M-413425-02-1 EPA MRID No.: 48843682 Date: 2011-09-06 ...Amended: 2012-01-05 GLP/GEP: yes, unpublished ...also filed: KIIA 7.2.1 /06 ...also filed: KIIA 7.2.3 /04


20120484 TGEURAP

2012-05-08

KIIA 7.1.2 /01


2012

[Furanone-4-14C] and [Ethyl-1-14C] and [Pyridine-2,6-14C]BYI 02960: Anaerobic Soil Metabolism Bayer CropScience, Report No.: MEF-11/514, Edition Number: M-421504-01-2 EPA MRID No.: 48843686 Date: 2012-01-03 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.1.2 /02

Mislankar, S. G.; Woodard, D.

2012

[Pyridine-2,614C]BYI 02960: Anaerobic soil metabolism Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP094, Edition Number: M-421993-01-1 Date: 2012-01-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.1.2 /03

Woodard, D.

2012

[Pyridine-2,614C]BYI 02960: Anaerobic soil metabolism in Springfield, Nebraska (USA) soil Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVL006, Edition Number: M-424987-01-1 Date: 2012-02-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.1.3 /01


2011

[Pyridinylmethyl-14C]BYI 02960 and [furanone-4-14C]BYI 02960: Phototransformation on soil Bayer CropScience, Report No.: MEF-10/351, Edition Number: M-405776-01-2 EPA MRID No.: 48843672 Date: 2011-03-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.2.1 /01

Menke, U. 2011



20120484 TGEURAP

2012-05-08

KIIA 7.2.1 /02


2011

[Furanone-4-14C]BYI 02960: Aerobic soil metabolism/degradation Bayer CropScience, Report No.: MEF-10/804, Edition Number: M-411625-01-2 EPA MRID No.: 48843676 Date: 2011-07-28 GLP/GEP: yes, unpublished ...also filed: KIIA 7.1.1 /02


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.2.1 /03

Ripperger, R. J.

2011

[Furanone-4-14C]BYI 02960: Aerobic soil metabolism in two US soils Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP037-2, Edition Number: M-405497-03-1 EPA MRID No.: 48843677 Date: 2011-01-14 ...Amended: 2012-01-05 GLP/GEP: yes, unpublished ...also filed: KIIA 7.1.1 /03


20120484 TGEURAP

2012-05-08

KIIA 7.2.1 /04


2011

[Ethyl-1-14C]BYI 02960: Aerobic soil metabolism Bayer CropScience, Report No.: MEF-10/858, Edition Number: M-414981-01-1 EPA MRID No.: 48843679 Date: 2011-09-08 GLP/GEP: yes, unpublished ...also filed: KIIA 7.1.1 /04


20120484 TGEURAP

2012-05-08

KIIA 7.2.1 /05


2011

[Pyridine-2,6-14C]BYI 02960: Aerobic soil metabolism Bayer CropScience, Report No.: MEF-10/880, Edition Number: M-411693-01-2 EPA MRID No.: 48843681 Date: 2011-07-28 GLP/GEP: yes, unpublished ...also filed: KIIA 7.1.1 /05


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.2.1 /06

Shepherd, J. J.

2011



20120484 TGEURAP

2012-05-08

KIIA 7.2.3 /01

Lowden, P.; Oddy, A. M.; Jones, M. K.

1997

Rate of degradation of the acid metabolite, (14C)-IC-O in three soils NI-25 Rhone-Poulenc Agriculture Ltd., Ongar, Essex, United Kingdom Bayer CropScience, Report No.: C007660, Edition Number: M-196378-01-1 Date: 1997-08-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.2.3 /04

Shepherd, J. J.

2011



20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.3.1 /01

Heinemann, O.

2011

Determination of the residues of BYI 02960 in/on soil after spraying of BYI 02960 SL 200 in the field in Germany, Italy, Spain and the United Kingdom Bayer CropScience, Report No.: 09-2702, Report includes Trial Nos.: 09-2702-01 09-2702-02 09-2702-03 09-2702-05 09-2702-06 09-2702-07 Edition Number: M-414245-01-1 Date: 2011-09-13 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.4.1 /01

Menke, U.; Telscher, M.

2008

[Pyridinylmethyl-14C]BYI 02960: Adsorption to and desorption from soils Bayer CropScience, Report No.: MEF-08/261, Edition Number: M-327492-01-2 EPA MRID No.: 48843662 Date: 2008-12-17 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.4.1 /02

Stroech, K. 2010

[Pyridinylmethyl-14C]BYI 02960: Adsorption/desorption on two soils Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP017, Edition Number: M-363541-01-1 EPA MRID No.: 48843663 Date: 2010-01-29 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.4.1 /03

Menke, U. 2011



20120484 TGEURAP

2012-05-08

KIIA 7.4.2 /01

Liu, A. C. 1997

Soil adsorption/desorption study 6-chloronicotinic acid (Acetamiprid metabolite) Rhone-Poulenc Ag Company, RTP, NC, USA Bayer CropScience, Report No.: C007666, Edition Number: M-196394-01-1 Date: 1997-09-15 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.4.2 /02


2011

[1-14C]BYI 02960-DFA (BCS-AB60481): Adsorption to and desorption from five soils Bayer CropScience, Report No.: MEF-10/538, Edition Number: M-413836-01-2 EPA MRID No.: 48843665 Date: 2011-08-26 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.4.3 /01

de Souza, T. J. T.

2012

Amendment no 001 to final report - Mobility of [Pyridine-2,6-14C]-BYI 02960 in Brazilian soils - Soil columns leaching method Bioensaios Analises e Consultoria Ambiental S/C Ltda., Viamao, Brazil Bayer CropScience, Report No.: 2301-LIX-344-11, Edition Number: M-424966-02-2 Date: 2012-02-08 ...Amended: 2012-06-05 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-424966-01-2)

KIIA 7.4.9 /01

Smeykal, H. 2008

BYI 02960, pure substance: Vapour pressure - Final report Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20080615.01, Edition Number: M-309853-01-1 Date: 2008-10-10 GLP/GEP: yes, unpublished ...also filed: KIIA 2.3.1 /01


20120484 TGEURAP

2012-05-08

KIIA 7.5 /01

Mislankar, S.; Woodard, D.

2011

BYI-02960: Hydrolytic degradation Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP019, Edition Number: M-398952-01-1 Date: 2011-01-07 GLP/GEP: yes, unpublished ...also filed: KIIA 2.9.1 /01


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.6 /01

Hall, L. R. 2011

Phototransformation of [14C]BYI 02960 in aqueous pH 7 buffer - amended report Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP042-1, Edition Number: M-418426-02-1 Date: 2011-11-28 ...Amended: 2012-03-05 GLP/GEP: yes, unpublished ...also filed: KIIA 2.9.2 /01 ...also filed: KIIA 2.9.4 /01


20120484 TGEURAP

2012-05-08

KIIA 7.6 /02

Heinemann, O.

2011

BYI 02960: Determination of the quantum yield and assessment of the environmental half-life of the direct photo-degradation in water Bayer CropScience, Report No.: MEF-11/554, Edition Number: M-414756-01-2 EPA MRID No.: 48843668 Date: 2011-09-26 GLP/GEP: yes, unpublished ...also filed: KIIA 2.9.3 /01 ...also filed: KIIA 2.9.4 /02


20120484 TGEURAP

2012-05-08

KIIA 7.6 /03

Hall, L. R. 2011

Phototransformation of [14C]BYI 02960 in natural water Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP020, Edition Number: M-415368-01-1 Date: 2011-08-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.8.2 /01

Xu, T. 2012

[Pyridine-2,6-14C]BYI 02960: Anaerobic aquatic metabolism in two water/sediment systems Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: MERVP027, Edition Number: M-422616-01-1 Date: 2012-01-17 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.8.3 /01

Hellpointner, E.; Unold, M.

2012

[Pyridine-2,6-14C]BYI 02960: Aerobic aquatic metabolism Bayer CropScience, Report No.: MEF-11/907, Edition Number: M-422359-01-1 EPA MRID No.: 48843690 Date: 2012-01-12 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.8.3 /02

Unold, M.; Menke, U.

2012

[Furanone-4-14C] and [ethyl-1-14C]BYI 02960: Aerobic aquatic metabolism Bayer CropScience, Report No.: MEF-10/730, Edition Number: M-426504-01-1 EPA MRID No.: 48843692 Date: 2012-02-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.8.3 /03

Hellpointner, E.; Unold, M.

2012

[1-14C]BYI 02960-DFA (BCS-AB60481): Aerobic aquatic degradation Bayer CropScience, Report No.: M-422371-01-1, Edition Number: M-422371-01-1 EPA MRID No.: 48843691 Date: 2012-01-12 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.8.3 /04

Bruns, E. 2012

Fate of BYI 02960 (tech.) in outdoor microcosm ponds simulating actual exposure conditions in agricultural use Bayer CropScience, Report No.: EBRVP109, Edition Number: M-427167-01-1 Date: 2012-03-20 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.10 /01

Hellpointner; E.

2010

BYI 02960: Calculation of the chemical half-life in the troposphere Bayer CropScience, Report No.: MEF-10/896, Edition Number: M-398741-01-2 EPA MRID No.: 48843671 Date: 2010-12-27 GLP/GEP: no, unpublished ...also filed: KIIA 2.10 /01

No

Y Bayer CropScience

20120484 TGEURAP

2012-05-08

KIIA 7.13 /01


2011

BCS-CC98193 (BYI 02960-DFEAF): Water solubility at pH 5, pH 7 and pH 9 (flask method) Bayer CropScience, Report No.: PA11/018, Edition Number: M-415753-01-1 Date: 2011-10-04 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.13 /02

Wiche, A.; Ziemer, F.

2011

BCS-CR74729 (BYI 02960-succinamide): Water solubility at pH 5, pH 7 and pH 9 (flask method) Bayer CropScience, Report No.: PA11/078, Edition Number: M-416651-01-1 Date: 2011-11-04 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.13 /03

Ziemer, F.; Strunk, B.

2011

BCS-CU93236 (BYI 02960-azabicyclosuccinamide Na-salt): Water solubility at pH 5, pH 7 and pH 9 (flask method) Bayer CropScience, Report No.: PA11/094, Edition Number: M-417069-01-1 Date: 2011-11-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08












Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.13 /04


2011

Difluoroacetic acid (BCS-AA56716): Miscibility with distilled water and solubility in water in a pH range of 1.6 to 13 Bayer CropScience, Report No.: PA10/042, Edition Number: M-418554-01-1 Date: 2011-11-29 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.13 /05

Kenji, M. 2001

Solubility of IC-0 in water Nisso Chemical Analysis Serv. Co., Ltd., Japan Nippon Soda, Report No.: C016679, Edition Number: M-202871-01-1 Date: 2001-09-27 GLP/GEP: yes, unpublished


2012-05-08

KIIA 7.13 /06

Eyrich, U.; Ziemer, F.

2011

BCS-CR74729 (BYI 02960-succinamide): Partition coefficients 1-octanol / water at pH 5, pH 7 and pH 9 (shake flask method) Bayer CropScience, Report No.: PA11/079, Edition Number: M-416883-01-1 Date: 2011-11-04 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.13 /07


2011

BCS-CU93236 (BYI 02960-azabicyclosuccinamide Na-salt): Partition coefficients 1-octanol / water at pH 5, pH 7 and pH 9 (shake flask method) Bayer CropScience, Report No.: PA11/093, Edition Number: M-416656-01-1 Date: 2011-11-04 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.13 /08


2011

Difluoroacetic acid (BCS-AA56716): Partition coefficients 1-octanol / water at pH 5, pH 7 and pH 9 (shake flask method) Bayer CropScience, Report No.: PA10/043, Edition Number: M-416624-01-1 Date: 2011-11-04 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08












Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.13 /09

Shirou, H. 2001

Partition coefficient (n-octanol/water) of IC-0 Nisso Chemical Analysis Serv. Co., Ltd., Japan Nippon Soda, Report No.: C017442, Edition Number: M-204285-01-1 Date: 2001-11-16 GLP/GEP: yes, unpublished


2012-05-08

KIIA 7.13 /10


2011

BCS-CC98193 (BYI 02960-DFEAF): Dissociation constant in water Bayer CropScience, Report No.: PA11/021, Edition Number: M-415757-01-1 Date: 2011-10-04 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.13 /11

Winkler, S. 2011

Difluoro acetic acid (BCS-AA56716): Determination of the dissociation constant in water Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20100366.02, Edition Number: M-418626-01-1 Date: 2011-11-18 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 7.13 /12

Kenji, M. 2001

Dissociation constant of IC-0 Nisso Chemical Analysis Serv. Co., Ltd., Japan Nippon Soda, Report No.: C016811, Edition Number: M-203097-01-1 Date: 2001-10-17 GLP/GEP: yes, unpublished


2012-05-08

KIIA 7.13 /13

Dornhagen, J.

2011

BCS-CC98193 (BYI 02960-DFEAF): Vapour pressure Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20110091.01, Edition Number: M-420457-01-1 Date: 2011-11-07 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08












Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 7.13 /14

Smeykal, H. 2011

Difluoroacetic acid (BCS-AA56716): Vapour pressure Siemens AG, Frankfurt am Main, Germany Bayer CropScience, Report No.: 20100366.01, Edition Number: M-418553-01-1 Date: 2011-11-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.1.1 /01

2010

Toxicity of BYI 02960 technical during an acute oral LD50 with the northern bobwhite quail (Colinus virginianus) Bayer CropScience, Report No.: EBRVP022, Edition Number: M-386036-01-1 EPA MRID No.: 48843715 Date: 2010-07-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.1.1 /02

2011

Toxicity of BYI 02960 technical during an acute oral LD50 with the canary (Serinus canaria) Bayer CropScience, Report No.: EBRVP036, Edition Number: M-408514-01-1 EPA MRID No.: 48843716 Date: 2011-05-25 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.1.1 /03

2011

Acute oral toxicity of chicken (Gallus gallus domesticus) with BYI 2960 (tech.), according to OECD 223 - limit test- Bayer CropScience, Report No.: BAR/LD 141, Edition Number: M-420519-01-2 Date: 2011-12-19 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.1.2 /01

2010

Toxicity of BYI 02960 technical during an acute dietary LC50 with the mallard duck (Anas platyrhynchos) Bayer CropScience, Report No.: EBRVP020, Edition Number: M-388718-01-1 EPA MRID No.: 48843719 Date: 2010-08-26 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.1.2 /02

2010

Toxicity of BYI 02960 technical during an acute dietary LC50 with the northern bobwhite quail (Colinus virginianus Bayer CropScience, Report No.: EBRVP021, Edition Number: M-394535-01-1 EPA MRID No.: 48843718 Date: 2010-11-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.1.4 /01

2011

Toxicity of BYI 02960 technical on reproduction to the mallard duck (Anas platyrhynchos) Bayer CropScience, Report No.: EBRVP018-1, Edition Number: M-412917-02-1 EPA MRID No.: 48843721 Date: 2011-08-25 ...Amended: 2012-03-19 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.1.4 /02

2012

Toxicity of BYI 02960 technical on reproduction to the northern bobwhite quail (Colinus virginianus) Bayer CropScience, Report No.: EBRVP019, Edition Number: M-424704-01-2 EPA MRID No.: 48843720 Date: 2012-02-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-424704-01-1)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.2.1.1 /01

2010

Acute toxicity of BYI 02960 technical to the rainbow trout (Oncorhynchus mykiss) under static conditions Bayer CropScience, Report No.: EBRVP041, Edition Number: M-390611-01-1 EPA MRID No.: 48843705 Date: 2010-09-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.2.1.1 /02

2011

Acute toxicity of BYI 02960 to Xenopus laevis under flow-through conditions Bayer CropScience, Report No.: EBRVP187, Edition Number: M-417822-01-1 EPA MRID No.: 48843737 Date: 2011-11-18 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.2.1.2 /01

2010

Acute toxicity of BYI 02960 technical to the fathead minnow (Pimephales promelas) under static conditions Bayer CropScience, Report No.: EBRVP035, Edition Number: M-392560-01-1 EPA MRID No.: 48843706 Date: 2010-10-21 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.2.1.2 /02

2011

Acute toxicity of BYI 02960 (tech.) to fish (Cyprinus carpio) under static conditions (limit test) Bayer CropScience, Report No.: EBRVP186, Edition Number: M-420407-01-2 Date: 2011-12-19 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.2.1.3 /01

2011

Acute toxicity of BYI 02960 succinamide (tech.) to fish (Oncorhynchus mykiss) under static conditions (limit test) Bayer CropScience, Report No.: EBRVP203, Edition Number: M-414293-01-2 Date: 2011-09-21 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08












Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.2.1.3 /02

2011

Acute toxicity of sodium difluoro acetate (BCS AB60481, tech.) to fish (Oncorhynchus mykiss) under static conditions (limit test) Bayer CropScience, Report No.: EBRVP080, Edition Number: M-413889-01-2 Date: 2011-09-12 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.2.4 /01

2011

Early life stage toxicity of BYI 02960 technical to the Fathead minnow (Pimephales promelas) under flow-through conditions Bayer CropScience, Report No.: EBRVP033, Edition Number: M-409339-01-1 EPA MRID No.: 48843714 Date: 2011-06-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.3.1.1 /01

Banman, C. S.; Lam, C. V.

2009

Acute toxicity of BYI 02960 to Daphnia magna under static conditions Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: EBRVP032, Edition Number: M-357476-01-1 EPA MRID No.: 48843701 Date: 2009-10-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.3.1.1 /02

Bruns, E. 2011

Acute toxicity of BCS-AB60481 to the waterflea Daphnia magna in a static laboratory test system - limit test- Bayer CropScience, Report No.: EBRVP079, Edition Number: M-409326-01-2 Date: 2011-06-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.3.1.1 /03

McElligott, A.

1997

Acute toxicity (48 hours) to Daphnids (Daphnia magna) under semi-static conditions IC-0 Rhone-Poulenc Agro, Sophia Antipolis, France Bayer CropScience, Report No.: SA97045, Edition Number: M-196569-01-1 Date: 1997-05-20 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.3.1.2 /01

Bruns, E. 2011

Acute toxicity of BYI 02960 (tech.) to larvae of Chironomus riparius in a 48 h static laboratory test system Bayer CropScience, Report No.: EBRVP026, Edition Number: M-414739-01-2 Date: 2011-09-26 GLP/GEP: yes, unpublished ...also filed: KIIA 8.5.1 /01


20120484 TGEURAP

2012-05-08

KIIA 8.3.1.2 /02

Bruns, E. 2011

Acute toxicity of BYI 02960-succinamide to larvae of Chironomus riparius in a 48 h static laboratory test system Bayer CropScience, Report No.: EBRVP202, Edition Number: M-417386-01-2 Date: 2011-11-17 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.3.1.2 /03

Bruns, E. 2012

Acute toxicity of BYI 02960-azabicyclosuccinamide (BCS-CS64875) to larvae of Chironomus riparius in a 48 h static laboratory test system Bayer CropScience, Report No.: EBRVP207, Edition Number: M-424404-01-1 Date: 2012-02-02 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.3.1.2 /04

Bowers, L. M.; Lam, C. V.

1998

Acute toxicity of 6-chloronicotinic acid (a metabolite of imidacloprid) to Chironomus tentans under static renewal conditions Bayer Corporation, Stilwell, KS, USA Bayer CropScience, Report No.: 108127, Edition Number: M-048448-01-1 EPA MRID No.: 44558901 Date: 1998-04-23 GLP/GEP: yes, unpublished


20040348 TG (MonAmi)

2004-09-24

KIIA 8.3.2.1 /01

Riebschlaeger, T.

2011

Effects of BYI 02960 (techn.) on development and reproductive output of the waterflea Daphnia magna in a static-renewal laboratory test system Bayer CropScience, Report No.: EBRVP209, Edition Number: M-414066-01-2 EPA MRID No.: 48843711 Date: 2011-09-15 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.3.2.1 /02

Riebschlaeger, T.

2012

Influence of BYI02960-succinamide (tech.) on development and reproductive output of the waterflea Daphnia magna in a static-renewal laboratory test system Bayer CropScience, Report No.: EBRVP185, Edition Number: M-424700-01-2 EPA MRID No.: 48843712 Date: 2012-02-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.3.2.2 /01

Bruns, E. 2011

Chironomus riparius 28-day chronic toxicity test with BYI 02960 (tech.) in a water-sediment system using spiked water Bayer CropScience, Report No.: EBRVP025, Edition Number: M-401792-01-2 Date: 2011-02-14 GLP/GEP: yes, unpublished ...also filed: KIIA 8.5.2 /01


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.3.2.2 /02

Bruns, E. 2011

Chironomus riparius 28-day chronic toxicity test with Sodium difluoroacetate in a water-sediment system using spiked water - limit test Bayer CropScience, Report No.: EBRVP181, Edition Number: M-415913-01-2 Date: 2011-10-06 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.3.2.2 /03

Bruns, E. 2011

Chironomus riparius 28-day chronic toxicity test with 6-Chloronicotinic acid in a water-sediment system using spiked water - limit test Bayer CropScience, Report No.: EBRVP183, Edition Number: M-416604-02-2 Date: 2011-10-18 ...Amended: 2011-12-20 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.4 /01


2010

Toxicity of BYI 02960 technical to the green alga Pseudokirchneriella subcapitata Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: EBRVP030, Edition Number: M-397552-01-1 EPA MRID No.: 48843732 Date: 2010-12-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.4 /02

Bruns, E. 2011

Pseudokirchneriella subcapitata growth inhibition test with BCS-AB60481 - limit test Bayer CropScience, Report No.: EBRVP077, Edition Number: M-409118-01-2 Date: 2011-06-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.4 /03

Sobczyk, H. 2011

Pseudokirchneriella subcapitata growth inhibition test with BYI 02960 - succinamide - limit test Bayer CropScience, Report No.: EBRVP184, Edition Number: M-414090-01-2 Date: 2011-09-23 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.4 /04

Bruns, E. 2012

Pseudokirchneriella subcapitata growth inhibition test with 6 - chloronicotinic acid Bayer CropScience, Report No.: EBRVP242, Edition Number: M-424145-01-2 Date: 2012-02-01 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.5.1 /01

Bruns, E. 2011

Acute toxicity of BYI 02960 (tech.) to larvae of Chironomus riparius in a 48 h static laboratory test system Bayer CropScience, Report No.: EBRVP026, Edition Number: M-414739-01-2 Date: 2011-09-26 GLP/GEP: yes, unpublished ...also filed: KIIA 8.3.1.2 /01


20120484 TGEURAP

2012-05-08

KIIA 8.5.2 /01

Bruns, E. 2011

Chironomus riparius 28-day chronic toxicity test with BYI 02960 (tech.) in a water-sediment system using spiked water Bayer CropScience, Report No.: EBRVP025, Edition Number: M-401792-01-2 Date: 2011-02-14 GLP/GEP: yes, unpublished ...also filed: KIIA 8.3.2.2 /01


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.6 /01

Banman, C. S.; Alexander, T. M.; Lam, C. V.

2010

Toxicity of BYI 02960 technical to duckweed (Lemna gibba G3) under static-renewal conditions Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: EBRVP043, Edition Number: M-398376-01-1 EPA MRID No.: 48843731 Date: 2010-12-21 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.7.1 /01

Schmitzer, S.

2008

Revised final report no.: 1 - Effects of BYI 02960 (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 41121035, Edition Number: M-308904-02-1 Date: 2008-08-20 ...Amended: 2012-03-22 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.7.1 /02

Schmitzer, S.

2010

Effects of BYI02960 - difluoroethyl - amino - furanone (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 60291035, Edition Number: M-398557-01-3 EPA MRID No.: 48843723 Date: 2010-12-21 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-398557-01-2)

KIIA 8.7.1 /03

Schmitzer, S.

2011

Effects of BYI 02960 - hydroxy (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 63901035, Edition Number: M-409606-01-2 Date: 2011-06-15 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.7.1 /04

Schmitzer, S.

2010

Effects of difluoroacetic acid (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 56331035, Edition Number: M-367915-01-2 Date: 2010-04-29 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.7.1 /05

Schmitzer, S.

2010

Effects of 6-chloronicotinic acid (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 60281035, Edition Number: M-395279-01-2 Date: 2010-11-19 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.7.1 /06

Schmitzer, S.

2010

Effects of 6-chloro-picolylalcohol (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 50911035, Edition Number: M-361234-01-2 Date: 2010-01-11 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.7.1 /07

Vergé, E. 2012

Flupyradifurone SL 200 G: Acute contact toxicity to the bumblebee Bombus terrestris L.(Hymenoptera, Apidae) under laboratory conditions (multi doses test) Eurofins-GAB GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S12-03216, Edition Number: M-443696-01-1 Date: 2012-12-13 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.8.1.1 /01

Jans, D. 2010

Toxicity to the parasitoid wasp Aphidius rhopalosiphi (DESTEPHANI-PEREZ) (Hymenoptera: Braconidae) using a laboratory test; BYI 02960 SL 200 g/L Bayer CropScience, Report No.: CW09/079, Edition Number: M-366965-01-3 EPA MRID No.: 48843744 Date: 2010-04-15 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-366965-01-2)

KIIA 8.8.1.2 /01

Jans, D. 2010

Toxicity to the predatory mite Typhlodromus pyri SCHEUTEN (Acari, Phytoseiidae) using a laboratory test; BYI 02960 SL 200 g/L Bayer CropScience, Report No.: CW09/073, Edition Number: M-366957-01-2 EPA MRID No.: 48843745 Date: 2010-04-15 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.9.1 /01

Leicher, T. 2010

BYI 02960 (tech.): Acute toxicity to earthworms (Eisenia fetida) tested in artificial soil Bayer CropScience, Report No.: LRT/RG-A-131/09, Edition Number: M-363742-01-2 EPA MRID No.: 48843746 Date: 2010-02-18 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.9.1 /02

Leicher, T. 2010

BYI 02960-difluoroacetic acid: acute toxicity to earthworms (Eisenia fetida) tested in artificial soil Bayer CropScience, Report No.: LRT/RG-A-135/10, Edition Number: M-368835-01-2 EPA MRID No.: 48843747 Date: 2010-04-12 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.9.1 /03

Wetton, P. M.

1999

Acute toxicity to earthworms (Eisenia foetida) IC-0 Safepharm Lab. Ltd., Derby, United Kingdom Bayer CropScience, Report No.: C007758, Edition Number: M-196591-01-1 Date: 1999-08-25 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.9.2 /01

Leicher, T. 2010

BYI 02960 SL 200 G: Effects on survival, growth and reproduction on the earthworm Eisenia fetida tested in artificial soil Bayer CropScience, Report No.: LRT-RG-R-76/09, Edition Number: M-392964-01-2 Date: 2010-10-21 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.9.2 /02

Leicher, T. 2010

BYI 02960 Difluoroacetic acid: Effects onsurvival, growth and reproduction on the earthworm Eisenia fetida tested in artifical soil with 10 % peat Bayer CropScience, Report No.: LRT-RG-R-81/10, Edition Number: M-398061-01-3 EPA MRID No.: 48843750 Date: 2010-12-16 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-398061-01-2)

KIIA 8.9.2 /03

Leicher, T.; Kratz, M. A.

2011

6-chloronicotinic acid (AE F161089): Effects on survival, growth and reproduction on the earthworm Eisenia fetida tested in artificial soil with 5 percent peat Bayer CropScience, Report No.: M-413562-02-3, Edition Number: M-413562-02-3 EPA MRID No.: 48843751 Date: 2011-09-05 ...Amended: 2012-02-23 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-413562-02-2)










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.10.1 /01

Frommholz, U.

2009

BYI 02960 a.s.: Determination of effects on nitrogen transformation in soil Bayer CropScience, Report No.: FRM-N-130/09, Edition Number: M-359803-01-2 Date: 2009-12-03 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.10.1 /02

Frommholz, U.

2011

6-chloronicotinic acid (AE F161089): Determination of effects on nitrogen transformation in soil Bayer CropScience, Report No.: FRM-N-156/11, Edition Number: M-408028-01-2 Date: 2011-05-20 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.10.2 /01

Schulz, L. 2011

BYI 02960 a.s.: Effects on the activity of soil microflora (carbon transformation test) BioChem agrar GmbH, Gerichshain, Germany Bayer CropScience, Report No.: 11 10 48 058 C, Edition Number: M-417194-01-2 EPA MRID No.: 48843754 Date: 2011-11-11 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.11.1 /01


2009

Acute toxicity of BYI 02960 technical to the sheepshead minnow (Cyprinodon variegatus) under static conditions Bayer CropScience LP, Stilwell, KS, USA Bayer CropScience, Report No.: EBRVP034, Edition Number: M-357479-01-1 EPA MRID No.: 48843710 Date: 2009-10-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.11.1 /02

Gallagher, S. P.; Kendall, T. Z.; Krueger, H. O.

2009

BYI 02960: A 96-hour shell deposition test with the eastern oyster (Crassostrea virginica) Wildlife International, Ltd., Easton, MD, USA Bayer CropScience, Report No.: EBRVP023, Edition Number: M-361668-01-1 EPA MRID No.: 48843703 Date: 2009-12-01 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.11.1 /03

Gallagher, S. P.; Kendall, T. Z.; Krueger, H.O.

2009

BYI 02960: A 96-hour static acute toxicity test with the saltwater mysid (Americamysis bahia) Wildlife International, Ltd., Easton, MD, USA Bayer CropScience, Report No.: 149A-236, Edition Number: M-364620-01-1 EPA MRID No.: 48843704 Date: 2009-12-08 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.11.1 /04

Claude, M. B.; Kendall, T. Z.; Krueger, H. O.

2011

BYI 02960: A flow-through life-cycle toxicity test with the saltwater mysid (Americanysis bahia) Wildlife International, Ltd., Easton, MD, USA Bayer CropScience, Report No.: EBRVP038, Edition Number: M-420783-01-1 Date: 2011-09-08 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.11.1 /05

Bruns, E.; Hoffmann, K.; Hager, J.

2013

Flupyradifurone (BYI 02960) - BCS opinion on the reproduction endpoint of the chronic study with Americamysis bahia Bayer CropScience, Report No.: M-452374-01-1, Edition Number: M-452374-01-1 Date: 2013-04-26 GLP/GEP: n.a., unpublished

No

Y Bayer CropScience

20120484 TGEURAP

2013-08-30










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.11.1 /06

Springer, T. 2013

Effect size, variation, and dependability of conclusions from NOEC and ECx calculations for for project 149A-242B, BYI 02960: A flow-through life-cycle toxicity test Wildlife International, Ltd., Easton, MD, USA Bayer CropScience, Report No.: 149A-242B, Edition Number: M-452382-01-1 Date: 2013-04-25 GLP/GEP: n.a., unpublished

No

Y Bayer CropScience

20120484 TGEURAP

2013-08-30

KIIA 8.12 /01

Gosch, H. 2010

BYI 02960 SL 200 g/L - Effects on the vegetative vigour of eleven species of non-target terrestrial plants (Tier 1) Bayer CropScience, Report No.: VV 10/002, Edition Number: M-397734-01-2 EPA MRID No.: 48843730 Date: 2010-12-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.12 /02

Gosch, H. 2010

BYI 02960 SL 200 g/L - Effects on the seedling emergence and growth of eleven species of non-target terrestrial plants (Tier 1) Bayer CropScience, Report No.: SE10/001, Edition Number: M-397727-01-2 EPA MRID No.: 48843729 Date: 2010-12-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.14 /01

Frommholz, U.

2009

BYI 02960 SL 200 G: Influence on the reproduction of the collembola species Folsomia candida tested in artificial soil with 5 % peat Bayer CropScience, Report No.: FRM-COLL-75/09, Edition Number: M-359728-01-2 EPA MRID No.: 48843755 Date: 2009-12-02 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.14 /02

Frommholz, U.

2010

Metabolite BYI 02960-difluoroacetic acid: Influence on the reproduction of the collembolan species Folsomia candida tested in artificial soil Bayer CropScience, Report No.: FRM-COLL-85/10, Edition Number: M-368675-01-3 EPA MRID No.: 48843756 Date: 2010-05-12 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-368675-01-2)

KIIA 8.14 /03

Frommholz, U.

2011

6-chloronicotinic acid (AE F161089): Influence on the reproduction of the collembolan species Folsomia candida tested in artificial soil Bayer CropScience, Report No.: FRM-COLL-111/11, Edition Number: M-407861-01-2 Date: 2011-05-18 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.14 /04

Kratz, M.-A. 2009

BYI 02960 SL 200 G: Influence on mortality and reproduction on the soil mite species Hypoaspis aculeifer tested in artificial soil with 5 % peat Bayer CropScience, Report No.: KRA-HR-19/09, Edition Number: M-358752-01-2 EPA MRID No.: 48843758 Date: 2009-11-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.14 /05

Kratz, M.-A. 2010

BYI 02960-DFA (BCS-AA56716): Influence on mortality and reproduction on the soil mite species Hypoaspis aculeifer tested in artificial soil with 5 % peat Bayer CropScience, Report No.: KRA-HR-27/10, Edition Number: M-390091-01-2 Date: 2010-09-15 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.14 /06

Kratz, M.-A. 2011

6-chloronicotinic acid (AE F161089): Influence on mortality and reproduction on the soil mite species Hypoaspis aculeifer tested in artificial soil Bayer CropScience, Report No.: KRA-HR-44/11, Edition Number: M-404434-01-2 EPA MRID No.: 48843760 Date: 2011-03-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.15 /01

Caspers, N. 2010

Activated sludge, respiration inhibition test with BYI 02960 (tech.) Currenta GmbH & Co. OHG, Leverkusen, Germany Bayer CropScience, Report No.: 2010/0089/01, Edition Number: M-377311-01-1 Date: 2010-06-21 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.16.1 /01

Kling, A. 2011

BYI 02960 - Assessment of chronic effects to the honey bee, Apis mellifera L., in a 10 days laboratory feeding test Eurofins Agroscience Services GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-02924, Report includes Trial Nos.: S10-02924-L1_BLEU Edition Number: M-400539-01-2 Date: 2011-01-13 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.16.1 /02

Kling, A. 2012

BYI 02960-difluoroethyl-amino-furanone (BYI 02960-DFEAF) - Assessment of chronic effects to the honey bee, Apis mellifera L., in a 10 days continuous laboratory feeding limit test Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S11-01959, Report includes Trial Nos.: S11-01959-L1_BLCF Edition Number: M-425174-01-2 EPA MRID No.: 48843763 Date: 2012-02-14 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.16.1 /03

Kling, A. 2012

BYI 02960-hydroxy - Assessment of chronic effects to the honey bee, Apis mellifera L., in a 10 days continuous laboratory feeding limit test Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S11-01960, Report includes Trial Nos.: S11-01960-L1_BLCF Edition Number: M-425212-01-2 EPA MRID No.: 48843764 Date: 2012-02-15 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.16.1 /04

Kling, A. 2012

Difluoroacetic acid - Assessment of chronic effects to the honey bee, Apis mellifera L., in a 10 days continuous laboratory feeding limit test Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S11-01939, Report includes Trial Nos.: S11-01939-L1_BLCF Edition Number: M-425105-01-1 Date: 2012-02-13 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.16.1 /05

Kling, A. 2012

6-chloronicotinic acid - Assessment of chronic effects to the honey bee, Apis mellifera L., in a 10 days continuous laboratory feeding limit test Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S11-01957, Report includes Trial Nos.: S11-01957-L1_BLCF Edition Number: M-425155-01-2 EPA MRID No.: 48843766 Date: 2012-02-13 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.16.1 /06

Kling, A. 2012

6-chloropicolyl alcohol - Assessment of chronic effects to the honey bee, Apis mellifera L., in a 10 days continuous laboratory feeding limit test Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S11-01958, Report includes Trial Nos.: S11-01958-L1_BLCF Edition Number: M-425159-01-2 EPA MRID No.: 48843767 Date: 2012-02-13 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.16.1 /07

Nikolakis, A.; Theis, M.; Przygoda, D.

2011

BYI 02960 tech.: Effects of exposure to spiked diet on honeybee larvae (Apis mellifera carnica) in an in vitro laboratory testing design Bayer CropScience, Report No.: E 318 3897-9, Edition Number: M-406645-01-3 EPA MRID No.: 48843768 Date: 2011-05-02 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08 (M-406645-01-2)

KIIA 8.16.1 /09

Gladbach, D.; Theis, M.; Przygoda, D.; Nikolakis, A.

2013

Assessment of chronic effects of BYI 02960 tech. to the honey bee, Apis mellifera L., in a 10 days continuous laboratory feeding test Bayer CropScience, Report No.: E 318 4561-8, Edition Number: M-462475-01-1 Date: 2013-08-26 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30

KIIA 8.16.2 /01

Leicher, T. 2011

BYI 02960: Effects on soil litter degradation after spray application Bayer CropScience, Report No.: LRT-SLD-45/11, Edition Number: M-413408-01-2 Date: 2011-09-06 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08










Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.16.2 /02

Leicher, T. 2011

BYI 02960: Effects on soil litter degradation if applied as seed treatment Bayer CropScience, Report No.: LRT-SLD-46/11, Edition Number: M-413416-01-2 Date: 2011-09-06 GLP/GEP: yes, unpublished


20120484 TGEURAP

2012-05-08

KIIA 8.16.2 /03

Nikolakis, A.; Krieg, V.; Aumeier, P.; Gladbach, D.

2012

Honey bee colony feeding study, evaluating the effects of BYI 02960-fortified sugar- and pollen diet on the development of honey bee colonies under confined semi-field conditions, followed by a post-exposure field observation period Bayer CropScience, Report No.: E 319 4111-0, Edition Number: M-438748-01-1 EPA MRID No.: 48843771 Date: 2012-09-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30

KIIA 8.16.2 /04

Rexer, H. U. 2012

Assessment of side effects on the honeybee (Apis mellifera L.), exposed to winter oil-seed rape, grown from seeds treated with BYI 02960 FS 480 G and sequentially sprayed with BYI 02960 SL 200 G during immediate pre- and full flowering in a long-term field study in Northern Germany Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-03261, Report includes Trial Nos.: 2012-09-27 S10-03261-L2 S10-03261-L3 Edition Number: M-438818-01-1 Date: 2012-09-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30








Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.16.2 /05

Rexer, H. U. 2012

Assessment of side effects on the honeybee (Apis mellifera L.), exposed to winter oil-seed rape, grown from seeds treated with BYI 02960 FS 480 G and sequentially sprayed with BYI 02960 SL 200 G during immediate pre- and full flowering in a long-term field study in France Eurofins Agroscience Services GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-03262, Report includes Trial Nos.: S10-03262-01 S10-03262-02 Edition Number: M-438819-01-1 Date: 2012-07-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30

KIIA 8.16.2 /06

Gould, T. J.; Lawrence, J.; Harbin, A. M.

2012

Determination of residues of BYI 02960 in blossoms, nectar, and pollen when applied via soil drench and Foliar Spray to melon under semi-field Conditions in North Carolina Eurofins Agroscience Services, Inc., Mebane, NC, USA Bayer CropScience, Report No.: RARVP019, Edition Number: M-435037-01-1 EPA MRID No.: 48844525 Date: 2012-07-24 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.16.2 /07

Bocksch, S. 2012

Determination of residues of BYI 02960 applied via drench application in watermelon in the semi-field Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S09-01391, Report includes Trial Nos.: S09-01391-01_BZEU Edition Number: M-424666-01-2 EPA MRID No.: 48844522 Date: 2012-02-09 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30

KIIA 8.16.2 /08

Bocksch, S. 2012

Determination of residues of BYI 02960 applied via drench application in tomato in the semi-field Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-03818, Report includes Trial Nos.: S10-03818-01 Edition Number: M-424683-01-2 EPA MRID No.: 48844521 Date: 2012-02-10 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.16.2 /09

Bocksch, S. 2012

Determination of residues of BYI 02960 applied via drench application in watermelon in the semi-field Eurofins Agroscience Services EcoChem GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-03825, Report includes Trial Nos.: S10-03825-01 Edition Number: M-424675-01-2 EPA MRID No.: 48844523 Date: 2012-02-08 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30

KIIA 8.16.2 /10

Rexer, H. U. 2013

Determination of residues of BYI 02960 after application of BYI 02960 SL 200 G once before and once during flowering in a semi-field honeybee (Apis mellifera L.) study in Phacelia tanacetifolia in 2012 Eurofins-GAB GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S12-00038, Report includes Trial Nos.: S12-00038-L1 S12-00038-L2 Edition Number: M-457246-01-1 Date: 2013-05-31 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30






Sivanto Prime




Author(s) Year



Data protection

granted Y/N



KIIA 8.16.2 /11

Rexer, H. U. 2012

A field study to determine residues of BYI 02960 in guttation liquid from winter oil-seed rape (OSR) plants in Northern Germany in 2010/2011 Eurofins Agroscience Services GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-03312, Report includes Trial Nos.: S10-03312-01 Edition Number: M-438826-01-1 Date: 2012-09-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30

KIIA 8.16.2 /12

Rexer, H. U. 2012

A field study to determine residues of BYI 02960 in guttation liquid from winter oil-seed rape (OSR) plants in France in 2010/2011 Eurofins Agroscience Services GmbH, Niefern-Oeschelbronn, Germany Bayer CropScience, Report No.: S10-03313, Report includes Trial Nos.: S10-03313-01 Edition Number: M-438829-01-1 Date: 2012-09-27 GLP/GEP: yes, unpublished


20120484 TGEURAP

2013-08-30





1. BESLUIT - Microsoft...2013/04/29 · HET COLLEGE BESLUIT tot toelating van bovenstaand middel....

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