HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1. BESLUIT
Op 10 juni 2014 is van
Bayer CropScience S.A.-N.V. Xxxxxxx 000
0000 XX XXXXXXXXX
een aanvraag tot wijziging van een toelating van een gewasbeschermingsmiddel (NL is CMS) ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) voor het gewasbeschermingsmiddel
Ascra Xpro
op basis van de werkzame stoffen bixafen, fluopyram en prothioconazool. Nederland is in deze een betrokken lidstaat, als bedoeld in artikel 36, tweede lid; de beoordelend lidstaat is Duitsland.
HET COLLEGE BESLUIT tot uitbreiding 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.
▪ 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)
Bij de uitbreiding worden nieuwe toepassingsgebieden aan het WG toegevoegd en komt een restrictiezin te vervallen vanwege de inwerkintreding van het nieuwe Activiteitenbesluit. Daarom wordt het WG zonder volgnummer (W.0) verhoogd naar W.1.
Omdat het gebruik wordt uitgebreid zijn respijttermijnen bij dit besluit niet van toepassing.
Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. De te hanteren W-coderingen en aflever- en opgebruiktermijnen voor oude verpakkingen zoals vastgesteld volgens het besluit beleidsregel respijttermijnen voor gewasbeschermingsmiddelen (Staatscourant 31 augustus 2016) staan vermeld onder “toelatingsinformatie” in bijlage I.
2. WETTELIJKE GRONDSLAG
Besluit | artikel 33 en artikel 36, derde lid, van de Verordening (EG) 1107/2009 |
Classificatie en etikettering | artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 |
Gebruikt toetsingskader | Bgb en Rgb d.d. 16 december 2011, Evaluation Manual Zonaal, GD Birds & Mammals 2012 en GD Dermal Absorption 2012 |
3. BEOORDELINGEN
3.1 Fysische en chemische eigenschappen
De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht.
3.2 Analysemethoden
De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd gebruik.
3.3 Risico voor de mens
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht.
3.4 Risico voor het milieu
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht.
3.5 Werkzaamheid
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het werkzaam is.
Voor nadere onderbouwing van de beoordelingen verwijzen wij u naar deel A en B van het Registration Report als toegevoegd aan de bijlagen van dit besluit overeenkomstig Besluit beleidsregel bekendmaken delen A en B van het Registration Report.
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), Xxxxxxx 0000, 0000 XX, XXX. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.
Ede, 5 oktober 2018
Het College voor de toelating van gewasbeschermingsmiddelen en biociden, voor deze:
de voorzitter,
Ir. X.X. xx Xxxxx
BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING
2.1 Aanvraaginformatie
Aanvraagnummer: 20145428 NLWTG
Type aanvraag: Aanvraag tot wijziging van toelating gewasbeschermingsmiddel (NL is CMS)
Middelnaam: Ascra Xpro
Verzenddatum aanvraag: 4 juni 2014
Formele registratiedatum: * 10 juni 2014
Datum in behandeling name:
* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.
2.2 Stofinformatie
Werkzame stof Gehalte
bixafen 65 g/L
fluopyram 65 g/L
prothioconazool 130 g/L
• De stof bixafen is per 1 oktober 2013 goedgekeurd volgens Verordening (EU) 1107/2009 (Uitvoeringsverordening (EU) 350/2013 d.d. 17 april 2013). De goedkeuring van deze werkzame stof expireert op 30 september 2023.
• De stof fluopyram is per 1 februari 2014 goedgekeurd volgens Verordening (EU) 1107/2009 (Uitvoeringsverordening (EU) 802/2013 d.d. 22 augustus 2013). De goedkeuring van deze werkzame stof expireert op 31 januari 2024.
• De stof prothioconazool is per 31 juli 2008 geplaatst op Xxxxx X van Richtlijn 91/414/EEG (2008/44/EC d.d. 4 april 2008) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd. De goedkeuring van deze werkzame stof expireert op 31 juli 2019.
2.3 Toelatingsinformatie
Toelatingsnummer: 15543 N
Expiratiedatum: 31 juli 0000
Xxxxxxxxx parallel of origineel: Wijziging Middel
Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel
Gebruikers: Professioneel
W-coderingen en aflever- en opgebruiktermijnen:
▪ W-codering professioneel gebruik: W1
▪ Vorige w-codering professioneel gebruik: W0
▪ Aflevertermijn professioneel gebruik: Niet van Toepassing
▪ Opgebruiktermijn professioneel gebruik: Niet van Toepassing
2.4 Verpakkingsinformatie
Aard van het preparaat: Emulgeerbaar concentraat
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE II Etikettering van het middel Ascra Xpro
Professioneel gebruik
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: fluopyram
prothioconazool
Pictogram GHS05
GHS07 GHS08 GHS09
Signaalwoord Gevaar
Gevarenaanduidingen H302 Schadelijk bij inslikken.
H317 Kan een allergische huidreactie veroorzaken. H318 Veroorzaakt ernstig oogletsel
H335 Kan irritatie van de luchtwegen veroorzaken.
H361d Wordt ervan verdacht het ongeboren kind te schaden.
H410 Zeer giftig voor in het water levende organismen, met langdurige gevolgen.
Voorzorgsmaatregelen P280 Beschermende handschoenen/beschermende
kleding/oogbescherming/gelaatsbescherming dragen.
P305 + P351 + P338 BIJ CONTACT MET DE OGEN: voorzichtig afspoelen met water gedurende een aantal minuten; contactlenzen verwijderen, indien mogelijk. Blijven spoelen.
P310 Onmiddellijk 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
REGISTRATION REPORT
Part A
Risk Management
Product name: Ascra Xpro Product code: 102000027828
Active Substance: Bixafen + Fluopyram +
Prothioconazole EC 260
(65+65+130 g/l)
Country: the Netherlands Central Zone
Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT
Applicant: Bayer Crop Science Date: September 2018 (Ctgb)
Applicant: Bayer Crop Science Evaluator: NL;
Ctgb
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.
Table of Contents
Geen inhoudsopgavegegevens gevonden.
PART A – Risk Management
This document describes the acceptable use conditions required for the zonal extension of the registration of Ascra Xpro containing bixafen, fluopyram and prothioconazole in the Netherlands.
The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 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 relating to Ascra Xpro where that data has not been considered in the EU review. Otherwise assessments for the safe use of Ascra Xpro have been made using endpoints agreed in the EU review of bixafen, fluopyram and prothioconazole.
This document describes the specific conditions of use and labelling required for the Netherlands for the first registration of Ascra Xpro.
Appendix 1 of this document is a copy of the approved product label for the Netherlands.
1 Details of the application
1.1 Application background
This application was submitted by Bayer CropScience.
The application was for approval of the extension of Ascra Xpro, an emulsifiable concentrate containing bixafen (65 g/L), fluopyram (65 g/L) and prothioconazole (130 g/L) for use as a fungicide on cereals.
1.2 Annex I inclusion
Bixafen was approved for inclusion into Annex I in accordance with Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (Implementing Regulation (EU) No. 350/2013, dated 17 April 2013) with the entry into force of 1 October 2013. Fluopyram was included into Annex I of Regulation (EC) No1107/2009, (Implementing Regulation (EU) No.802/2013, dated 22 August 2013) with the entry into force of 1 February 2014. Prothioconazole was included in Annex I of Directive 91/414, (Directive 2008/44/EC dated 4 April 2008) with the entry into force on 1 August 2008.
The product has not been evaluated as the representative formulation during the Annex I inclusion of bixafen, fluopyram or prothioconazole.
Bixafen
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bixafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
According to Xxxxx I of the Implementing Regulation for bixafen, Member States must pay particular attention to:
⮚ the residues of bixafen and of its metabolites in rotational crops
(In agreement with the RMS for bixafen – CRD in the UK -, this point is being addressed by the initiation of new rotational crop studies.)
⮚ the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions
⮚ the risk to aquatic organisms
⮚ the risk to soil and sediment-dwelling organisms
Fluopyram
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bixafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In the Annex I Inclusion Regulation for fluopyram there are specific provisions under Part B which need to be considered related to ecotoxicology.
In this overall assessment Member States shall pay particular attention to the risk to birds and aquatic organisms. The applicant shall submit confirmatory information as regards:
⮚ the long-term risk to insectivorous birds;
⮚ the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit to the Commission, Member States and the Authority the information set out in point 1 by 1 February 2016 and the information set out in point 2 within two years after adoption of the corresponding OECD test guidelines on endocrine disruption.
Prothioconazole
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review reports on the active substances prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.
In the Annex I Inclusion Directive for prothioconazole Member States must pay particular attention to:
⮚ the operator safety in spray applications. Conditions of use shall include adequate protective measures,
⮚ the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,
⮚ the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate.
Conditions of use shall include risk mitigation measures, where appropriate.
The concerned Member States shall request the submission of:
⮚ information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin,
⮚ a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds,
⮚ information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment.
These concerns have been addressed within the current submission.
For bixafen, the EFSA conclusion of the peer review (EFSA Journal 2012; 10(11): 2917) and the draft Review Report are considered to provide the relevant scientific information for the review of the product.
For fluopyram, the EFSA conclusion of the peer review (EFSA Journal 2013; 11(4): 3052) and the Review Report (SANCO/11456/2013 rev 2: draft) finalised on 16 July 2013 are considered to provide the relevant scientific information for the review of the product.
The review report for prothioconazole (SANCO/11209/2010 Rev. 2) and the (EFSA Scientific Report (2007) 106, 1-98) are considered to provide the relevant scientific information for the review of the product.
1.3 Regulatory approach
To obtain approval the product Ascra Xpro must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Xxxxx XX and Xxxxx XXX, with an assessment to Uniform Principles, using Annex I agreed end-points. This application was submitted in order to allow the first approval 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 1107/2009 Bayer claim 10 years protection for these studies and reports. The authority confirms that these studies and reports are protected for 10 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
No letter of access is required as Bayer CropScience is the owner of all studies. 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.
2 Details of the authorisation
2.1 Product identity
Product Name | Bixafen + Fluopyram + Prothioconazole EC 260 (65+65+130 g/l) Specification no. 102000027828 Trade name: Ascra Xpro |
Authorization Number (for re-registration) | N 15543 |
Function | Fungicide |
Applicant | Bayer CropScience SA-NV |
Composition | 65 g/L bixafen + 65 g/L fluopyram + 130 g/L prothioconazole |
Formulation type | Emulsifiable concentrate [Code: EC] |
Packaging | Bottle/Canister 1 to 15 litres: - PA / adhesive / HDPE, - EVOH / adhesive / HDPE. Screw cap 50-63 mm (with HF seal or internal wad) - to fit container neck as defined in ECPA One Trip Container Guidelines. Injection moulded of PE or PP |
2.2 Classification and labelling
2.2.1 Classification and labelling under Directive 99/45/EC
Not relevant as classification is proposed according to Regulation (EC) 1272/2008 Current classification of the product is mentioned.
Hazardous components which must be listed on the label:
• Fluopyram
• Prothioconazole
Pictogram: GHS05 GHS07 GHS08 GHS09
Signal word: Danger
2.2.2 R and S phrases under Directive 2003/82/EC (Annex IV and V)
Not relevant as classification is proposed according to Regulation (EC) 1272/2008
Current classification of the product is mentioned. Hazard statements
H302 Harmful if swallowed
H317 May cause an allergic skin reaction
H318 Causes serious eye damage
H335 May cause respiratory irritation.
H361d Suspected of damaging the unborn child.
H410 Very toxic to aquatic life with long lasting effects
EUH401 To avoid risks to human health and the environment, comply with the instructions for use.
Precautionary statements
P280 Wear protective gloves/protective clothing/eye protection/face protection. P305 + P351 + IF IN EYES: Rinse cautiously with water for several minutes. Remove contact P338 lenses, if present and easy to do. Continue rinsing.
P310 Immediately call a POISON CENTER or doctor/physician
P501 Dispose of contents/container in accordance with local regulation
2.2.3 Other phrases
SP1 Do not contaminate water with the product or its container.
2.3 Product uses
PPP (product name/code): Ascra Xpro Formulation type: EC (a, b)
Active substance 1: Bixafen (BIX) Conc. of as 1: 65 g/L(c)
Active substance 2: Fluopyram (FLU) Conc. of as 2: 65 g/L (c)
Active substance 3: Prothioconazole (PTZ) Conc. of as ….: 130 g/L (c)
Safener: - Conc. of safener: -
Synergist: | - | Conc. of synergist: |
Applicant: | Bayer CropScience SA-NV | Professional use: |
Zone(s): Verified by MS: | Central yes/no | Non professional use: |
Field of use: | Fungicide |
)
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
Use- No. (e) | Member state(s) | Crop and/ or situation (crop destination / purpose of crop) | F, Fn, Fpn G, Gn, Gpn 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 (f) | |||||
Method / Kind | Timing / Growth stage of crop & season | Max. number a) per use b) per crop/ season | Min. interval between applications (days) | kg or L product / ha a) max. rate per appl. b) max. total rate per crop/season | g or kg as/ha a) max. rate per appl. b) max. total rate per crop/season | Water L/ha min - max | |||||||
Only new Zonal uses (field or outdoor uses) | |||||||||||||
1 | NL | Winter barley | F | Erysiphe graminis | Overall spray | BBCH 30-61 | a) 1 | - | a) 1.2 | a) 78 BIX + | 000 - 000 | - | |
(XXXXX) | (XXXXXX) | April-June | 78 FLU + | ||||||||||
Pseudocercosporella | 156 PTZ | ||||||||||||
herpotrichoides | |||||||||||||
(PSDCHE) | b) 1 | b) 1.2 | b) 78 BIX + | ||||||||||
Puccinia hordei | 78 FLU + | ||||||||||||
(PUCCHD) | 000 XXX | ||||||||||||
Xxxxxxxxx: Bayer Crop Science Evaluator: NL; Ctgb
Date: September 2018
Pyrenophora teres (PYRNTE) Ramularia collo-cygni (RAMUCC) Rhynchosporium secalis (RHYNSE) | |||||||||||||
2 | NL | Spring barley | F | Erysiphe graminis | Overall spray | BBCH 30-61 | a) 1 | - | a) 1.2 | a) 78 BIX + | 000 - 000 | - | |
(XXXXX) | (XXXXXX) | April-June | 78 FLU + | ||||||||||
Pseudocercosporella | 156 PTZ | ||||||||||||
herpotrichoides | |||||||||||||
(PSDCHE) | b) 1 | b) 1.2 | b) 78 BIX + | ||||||||||
Puccinia hordei | 78 FLU + | ||||||||||||
(PUCCHD) | 156 PTZ | ||||||||||||
Pyrenophora teres | |||||||||||||
(PYRNTE) | |||||||||||||
Ramularia collo-cygni | |||||||||||||
(RAMUCC) | |||||||||||||
Rhynchosporium secalis | |||||||||||||
(RHYNSE) | |||||||||||||
3 | NL | Oats | F | Puccinia coronate | Overall spray | BBCH 30-61 | a) 1 | - | a) 1.2 | a) 78 BIX + | 150 - 400 | - | |
(AVESA) | (PUCCCA) | April-June | 78 FLU + | ||||||||||
156 PTZ | |||||||||||||
b) 1 | b) 1.2 | b) 78 BIX + | |||||||||||
78 FLU + | |||||||||||||
000 XXX |
Xxxx X
Xxxxxxxx Xxxxxxxxxx - Xxxxxxxxxxx
Ascra Xpro Registration Report – Central Zone Page 18 of 58
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)
The product Ascra Xpro is an emulsifiable concentrate. All studies have been performed in accordance with the current requirements, and the results are deemed to be acceptable. The appearance of the product is that of a clear light brown liquid with a rancid odour. Ascra Xpro is not explosive, not flammable and not oxidizing. It has a kinematic viscosity of 24.9-25.1 mm²/s at 40 °C, and thus poses no aspiration hazard. It has a self-ignition temperature of 360 °C. A 1% dilution in water has a pH value of 5.9. In some cases, a significant amount of foam was produced (slightly above 60 mL), but was not considered as critical and no measures were needed. For the present purpose, this was considered acceptable in light of its other technical characteristics. The combined technical characteristics are acceptable for an emulsifiable concentrate formulation.
The stability data indicate a shelf life of at least 2 years at ambient temperature in HDPE/PA and HDPE/EVOH (COEX). During the shelf-life tests it was however observed, that prolonged exposure of the product in its commercial packaging to sunlight was likely to have caused increased generation of prothioconazole-desthio up to levels exceeding the acceptable limit value of 0.0064% (of the formulation). No further recommendation regarding storage is however proposed, as PPP are to be stored in a cabinet out of sunlight by default.
Implications for labelling: None.
Compliance with FAO specifications: The product Ascra Xpro complies with FAO specifications.
Compatibility of mixtures: not relevant as the product is not recommended for use with other pesticides.
Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable.
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)
Analytical methods for determination of bixafen, fluopyram, prothioconazole, impurities and relevance of CIPAC methods in Ascra Xpro were not evaluated as part of the EU review of neither bixafen, fluopyram nor prothioconazole. Therefore all relevant data are provided and are considered adequate. Analytical methods for the determination of relevant impurities toluene and prothioconazole-desthio have been evaluated and been deemed acceptable in the Registration Report of Ascra Xpro (zRMS = DE).
There is no CIPAC method available for the determination of bixafen or fluopyram or prothioconazole in EC-formulations like Ascra Xpro.
3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
Analytical methods are active substance data and were provided in the EU review of bixafen, fluopyram and prothioconazole and were considered adequate. However additional data on methods/validation in plants, soil, water and air for bixafen, fluopyram, prothioconazole and its metabolites have been provided. All data are considered adequate.
For surface water, bixafen can be monitored using LC-MS/MS (LOQ=0.05 µg/L), evaluated in the DAR. Fluopyram can be monitored by LC-MS/MS (LOQ=0.05 µg/L), evaluated in the DAR. Prothioconazole and prothioconazole-desthio can be monitored in surface water (both 0.05 µg/L) using a LC-MS/MS method which was evaluated by zRMS Germany according to SANCO/825/00 rev. 7. Fluopyram residues can be monitored in food of plant origin by GC-MS and in food of animal origin, soil, water and air by LC-MS/MS. Bixafen residues can be monitored by LC-MS/MS for all plant and plant products, animal products, soil, water and air. Prothioconazole residues can be monitored in food of plants and soil by GC- MS and LC-MS/MS and in food of animal origin, water and air by LC-MS/MS. Methods for body fluids and tissues are not required, because bixafen, fluopyram and prothioconazole are not considered to be toxic or very toxic (T / T+) nor are they classified according to GHS as follows: Acute toxicity (cat. 1 - 3), CMR (cat. 1) or STOT (cat. 1) (SANCO/825/00 rev. 8.1).
3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7)
3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1)
Acute toxicity studies for Ascra Xpro were not evaluated as part of the EU review of bixafen fluopyram or prothioconazole. Therefore, all relevant data were provided and are considered adequate.
Study/Parameter | Species (sex) | Results | Classification |
Acute oral / LD50 (mg/kg bw) | Rat (Female) | 300 mg/kg bw < LD50 < 2000 mg/kg bw | Acute tox. 4 H302 |
Acute dermal / LD50 (mg/kg bw) | Rat (Male & Female) | LD50 >2000 mg/kg bw | None |
Acute skin irritation | Rabbit (Female) | Not irritant | None |
Acute eye irritation | Rabbit (Female) | Severely irritant | Eye dam. 1 H318 |
Skin sensitisation test, LLNA in mice | Mouse (Female) | Sensitising | Skin sens. 1 H317 xxx.xxx. 1B |
Ascra Xpro containing 65 g/L bixafen, 65 g/L fluopyram and 130 g/L prothioconazole, has a low toxicity in respect to acute oral and dermal toxicity and is not irritating to the rabbit skin. It has been found to be classifiable for irritancy to rabbit eyes and is a skin sensitizer in the LLNA in mice. Taking into account all submitted data, Ascra Xpro should be labelled as harmful, sensitising and irritating with phrases H302, H317 and H318.
3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3)
The risk to the operator was already evaluated by Ctgb for Ascra Xpro in cereals at an application rate of 1.5L/ha at BBCH 30-61 and an acceptable risk with the use of PPE was concluded. For details, please
refer to authorization 15543 N (application number 20170965NLWERGZ, approved by Ctgb in January 2018).
The risk assessment for 1.5L/ha at BBCH 30-61 in cereals (one application) covers the risk for the intended uses at 1.2L/ha (one application) at BBCH 30-61 in barley and oats.
According to the German model calculations in the current authorization (15543 N), the risk for the operator using Ascra Xpro is acceptable with the use of personal protective equipment (gloves during mixing/loading and application and coverall and sturdy footwear during application). Combined toxicity was also addressed. The combined exposure to bixafen, fluopyram, prothioconazole and prothioconazole- desthio amounts to 32% of the AOEL for operators wearing gloves during mixing/loading and application and protective clothing during application.
Therefore, the use of Ascra Xpro in low crops (cereals) is regarded to be acceptable for the operator with the use of gloves during mixing/loading and application and a coverall during application also taking into account combination toxicity.
3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4)
The current risk assessment for one application 1.5L/ha at BBCH 30-61 in cereals (15543 N) covers the risk for the intended uses at 1.2L/ha for one application at BBCH 30-61 in barley and oats. It is concluded that there is no undue risk to any bystander or resident after accidental short-term exposure to Ascra Xpro, also when taking into account combination toxicity.
3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5)
The risk assessment in the current authorization for 1.5L/ha at BBCH 30-61 in cereals (15543 N) covers the risk for the intended uses at 1.2L/ha at BBCH 30-61 in spring barley and oats. It is concluded that there is no unacceptable risk anticipated for the worker wearing working coverall and gloves, when possible re-entering crops treated with Ascra Xpro. This conclusion is also valid when taking into account combination toxicity.
Therefore the following restriction sentence should be included on the WG:
• Draag beschermende handschoenen bij werkzaamheden aan behandeld gewas.
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)
This request for label extension concerns the use of a plant protection product containing the active substances bixafen, fluopyram and prothioconazole on barley and oats. Bixafen, fluopyram and prothioconazole have been reviewed at EU level and the evaluation data on all relevant aspects of the residue behaviour of the substances are presented in the respective Draft Assessment Reports, Annex B.7 including addenda and in the EFSA Conclusion (EFSA Journal 2012;10(11):2917) for bixafen, the EFSA Conclusion, (EFSA Journal 2013;11(1):3052) for fluopyram and the EFSA Scientific Report (2007, 106) for prothioconazole.
The uses on cereals were evaluated on EU level as representative uses for bixafen and prothioconazole and cover the uses applied for. Although no further studies for bixafen and prothioconazole are required,
some supplementary residue trials supporting the use patterns for the product ‘BIX+FLU+PTZ EC 260’ in/on wheat and barley conducted in northern Europe were reported in the dossier for confirmation. These trials are also acceptable to support the uses with fluopyram in barley and oats, as these were not evaluated as representative uses during the approval of the active substance fluopyram.
In conclusion, all data already evaluated during the EU review of bixafen and prothioconazole and the newly submitted data for fluopyram are sufficient to support the uses of ‘BIX+FLU+PTZ EC 260’ in cereals. It should be noted, however, that EFSA identified a data gap for bixafen “to provide rotational crop field trials on cereals, leafy vegetables and root vegetables at a dose rate covering the calculated minimum plateau concentration of bixafen and to determine the residue levels of bixafen and metabolites M21, M43, M44 and M20.”
The Ctgb, however, follows the conclusions drawn by the zRMS Germany that this data gap has been sufficiently elucidated with respect to the GAPs applied for. Since (i) the intended uses of bixafen are only on cereals and continuous cultivation and treatment with bixafen is unlikely according to common agricultural practices, (ii) residues in rotational crops seen in the confined studies were only slightly above the LOQ and consisted predominantly of bixafen and bixafen-desmethyl (M21), (iii) the experimental conditions in the confined study (bare soil application) and the plateau calculation parameters were very conservative, MRL compliance for rotational crops under realistic field conditions is assumed.
3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10)
The chronic and the short-term intake of bixafen, fluopyram and prothioconazole residues was calculated using EFSA’s PRIMo rev.2. It can be concluded that the uses are unlikely to present a public health concern if the product is applied according to the proposed GAP.
3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)
No new studies are presented for bixafen, fluopyram and prothioconazole; all data were reviewed in the corresponding EU reviews. Appropriate endpoints from the EU review or from the original dossier were used to calculate PECs for BIX + FLU + PTZ EC 260, bixafen, fluopyram and prothioconazole and their metabolites in soil, surface water, ground water and air for the intended use patterns.
Based on new data provided in this submission, appropriate endpoints were used to calculate PECs for the bixafen metabolite M44.
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points
9.4 and 9.5)
Calculations of predicted environmental concentrations in soil (PECsoil) presented in the Core Assessment represent a worst-case use pattern and fully cover the use patterns supported in the Netherlands considered as less critical or the same.
3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6)
Calculations of predicted environmental concentrations in groundwater (PECgw) have been evaluated by CTGB for BIX+FLU+PTZ EC260 in cereals at an application rate of 1.5L/ha at BBCH 30-61. Please
refer to the registration report (RR) of ASCRA XPRO on CIRCABC . Additional calculations for Bixafen and its metabolite M44 were performed and assessed. The metabolite M44 was deemed non- relevant. (See National Addendum (Part B8 and Part B10) as published by CTGB (xxxxx://xxxxxxxxxxx.xxxx.xx. Authorization number: N15543).
The calculations for 1.5L/ha at BBCH 30-61 in cereals cover the intended uses at 1.2L/ha at BBCH 30-61 in cereals.
Monitoring data groundwater
Bixafen
There are no data available regarding the presence of the substance bixafen in groundwater
Fluopyram
There are no data available regarding the presence of the substance fluopyram in groundwater
Prothioconazole
There are no data available regarding the presence of the substance prothioconazole in groundwater.
3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8)
Calculations of predicted environmental concentrations in surface water (PECsw) have been evaluated by Ctgb for BIX+FLU+PTZ EC260 in cereals at an application rate of 1.5L/ha at BBCH 30-61. Please refer to the registration report of ASCRA XPRO on CIRCABC (see footnote in Section IIIA 9.5) and the National Addendum (Part B8) as published by CTGB (xxxxx://xxxxxxxxxxx.xxxx.xx. Authorization number: N15543).
The calculations for 1.5L/ha at BBCH 30-61 in cereals cover the intended uses at 1.2L/ha at BBCH 30-61 in cereals.
Monitoring data surface water
In 2014, version 3 of the Pesticide Atlas was launched, which includes a statistical correlation analysis between concentrations, threshold exceedance and land use, which may indicate probable relationships. In this version also the correlation analysis of land use with the environmental quality standards (EQS) of the Water Framework Directive (WFD) is included.
Data from the Pesticide Atlas are used to evaluate potential exceedances of the authorisation threshold and environmental quality standards (MKN in Dutch, data source xxxx://xxx.xxxx.xx/xxx/Xxxxxx). These environmental quality standards consist either of the harmonised WFD thresholds derived according to the Fraunhofer methodology1 (AA-EQS and MAC-EQS) or of an MPC value (which is usually derived on the basis of outdated guidance). When EQS values according to the Water Framework Directive are available, the MPC value is not used further in the analysis of monitoring data for the purpose of the registration.
1 X.X.X. xxx Xxxxxxxxxxx and E.M.J. Verbruggen, Guidance for the derivation of environmental risk limits within the framework of 'International and national environmental quality standards for substances in the Netherlands' (INS). Revision 2007’. RIVM
report 601782001.
Bixafen
The active substance bixafen was observed in the surface water (most recent data from 2016). In Table 3.1.5.3-1 the number of observations in the surface water are presented. The authorisation threshold equals 0.46 µg a.s./L. (04/11/2011) (consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case [0.1*NOECfish]).
No EQS or MCP-value is set for bixafen in the Pesticide Atlas.
Table 3.1.5.3-1 Monitoring data in Dutch surface water for bixafen (from xxx.xxxxxxxxxxxxxxx.xx, version 3)
Total no of locations
n > authorisation
n > EQS
(2016) threshold
MAC- EQS
AA-EQS MPC (ad-
hoc/indicative)
93* 0 n.a.** n.a. n.a.
* the number of observations at each location varies between 1 and 30, total number of measurements is 570 in 2016.
** n.a. not available
As there is no exceedance of thresholds, the monitoring data have no consequences for the proposed use(s) of the product.
Fluopyram
The active substance Fluopyram was observed in the surface water (most recent data from 2016). In Table 3.1.5.3-2 the number of observations in the surface water are presented. The authorisation threshold equals 4.4 µg a.s./L (consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case [0.01*EC50 invertebrate (C. virginia)]).
No EQS or MCP-value is set for fluopyram in the Pesticide Atlas.
Table 3.1.5.3-2 Monitoring data in Dutch surface water for fluopyram (from xxx.xxxxxxxxxxxxxxx.xx, version 3)
Total no of locations
n > authorisation
n > EQS
(2016) threshold
MAC- EQS
AA-EQS MPC (ad-
hoc/indicative)
29* 0 n.a.** n.a. n.a.
* the number of observations at each location varies between 4 and 30, total number of measurements is 140 in 2016.
** n.a. not available
As there is no exceedance of thresholds, the monitoring data have no consequences for the proposed use(s) of the product.
Prothioconazole
The active substance prothioconazole was observed in the surface water (most recent data from 2015). In Table 3.1.5.3-3 the number of observations in the surface water are presented. The authorisation threshold equals 13 µg a.s./L (08-01-2010) (consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case [0.01*EC50 Daphnia]).
The relevant EQS for this substance are the WFD thresholds and equals 3.7 µg/L (11-11-2013) for the AA-EQS.
Table 3.1.5.3-3 Monitoring data in Dutch surface water for prothioconazole (from xxx.xxxxxxxxxxxxxxx.xx, version 3)
Total no of locations
n > authorisation
n > EQS
(2015) threshold
MAC- EQS
AA-EQS MPC (ad-
hoc/indicative)
71* 0 n.a.** n.a. 0
* the number of observations at each location varies between 1 and 30, total number of measurements is 503 in 2016.
** n.a. not available
As there is no exceedance of thresholds, the monitoring data have no consequences for the proposed uses of the product.
Prothioconazole-desthio (prothioconazole-metabolite)
The metabolite of prothioconazole, prothioconazole-desthio, was observed in the surface water (most recent data from 2016). In Table 3.1.5.3-4 the number of observations in the surface water are presented. The authorisation threshold equals 0.334 µg/L (03-12-2010) (consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case [0.1*NOEC Fish]).
No EQS or MCP-value is set for prothioconazole-desthio in the Pesticide Atlas.
Table 3.1.5.3-3 Monitoring data in Dutch surface water for prothioconazole-desthio (from xxx.xxxxxxxxxxxxxxx.xx, version 3)
Total no of locations
n > authorisation
n > EQS
(2016) threshold
MAC- EQS
AA-EQS MPC (ad-
hoc/indicative)
5* 0 n.a.** n.a. n.a.
* the number of observations at each location varies between 1 and 30, total number of measurements is 45 in 2016.
** n.a. not available
As there is no exceedance of thresholds, the monitoring data have no consequences for the proposed uses of the product.
Drinking water criterion
The assessment methodology followed is developed by the WG implementation drinking water criterion and outlined in Alterra report 16352 and described in the Ctgb Evaluation Manual, NL part, Chapter 6 surface water.
Substances are categorized as new substances on the Dutch market (less than 3 years authorisation) or existing substances on the Dutch market (authorised for more than 3 years).
2 Xxxxxxxxx et al. (2008). Development of an assessment methodology to evaluate agricultural use of plant protection products for drinking water production from surface waters - A proposal for the registration procedure in the Netherlands. Alterra-Report 1635
- For new substances, a pre-registration calculation is performed.
- For existing substances, the assessment is based on monitoring data of VEWIN (drinking water board). o If for an existing substance based on monitoring data no problems are expected by VEWIN, Ctgb follows this VEWIN assessment.
o If for an existing substance based on monitoring data a potential problem is identified by XXXXX, Ctgb assesses whether the 90th percentile of the monitoring data meet the drinking water criterion at each individual drinking water abstraction point.
Prothioconazole has been on the Dutch market for > 3 years (authorised since 29-05-2006). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by the Ctgb about the product and its active substance, the Ctgb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. The Ctgb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water are met.
Fluopyram has been on the Dutch market for > 3 years (authorised since 18-01-2013). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by the Ctgb about the product and its active substance, the Ctgb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. The Ctgb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water are met.
Bixafen has been on the Dutch market for > 3 years (authorised since 04-11-2011). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by the Ctgb about the product and its active substance, the Ctgb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. The Ctgb does under this approach expect no exceeding of 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)
Bixafen
Bixafen has a very low vapour pressure of 4.6 × 10-8 Pa at 20°C. Therefore, it can be concluded that significant volatilization of bixafen is not to be expected.
In addition, estimates of the chemical lifetime in the troposphere resulted in a half-life of 1.26 days.
Fluopyram
The vapour pressure of fluopyram (1.2 × 10-6 Pa extrapolated for 20 °C, Xxxxxxx 0, Xxxxx IIA 2.3.1) and the calculated Henry’s constant (2.98 × 10-5 Pa m3 mol-1 in water at pH 7 and 20°C, Section 1, Point IIA 2.3.2) do not trigger volatility studies under laboratory conditions.
The half-life in air of fluopyram was assessed by calculations with the computer program AOPWIN™ (v 1.91) according to Xxxxxxxx to result in half-life (T1/2) of 1.73 days when based on a typical mean concentration of hydroxyl radicals for 12 hours daylight intervals.
Various moieties were identified within the molecule as potential reaction sites of fluopyram with atmospheric hydroxyl radicals to contribute significantly to the overall degradation of the substance in the atmosphere.
Based on the short half-life time in air, there is no potential for fluopyram for a long-range transport or accumulation in the atmosphere. Furthermore, only limited quantities of fluopyram will enter the atmosphere, due to the low vapour pressure of the substance.
Prothioconazole
The fate and behaviour in air of prothioconazole was evaluated during the respective EU review for Annex I inclusion. No additional studies have been performed.
Prothioconazole has a very low vapour pressure of << 4 × 10-7 Pa. Therefore, it can be concluded that significant volatilisation of prothioconazole is not to be expected.
In addition, estimates of the chemical lifetime in the troposphere resulted in half lives < 1 day.
3.1.6 Ecotoxicology (Part B, Section 6, Point 10)
No unacceptable risk to non-target organisms is to be expected from the application of BIX + FLU + PTZ EC 260 when used as recommended.
The available ecotoxicity data and the relevant exposure data as combined in the respective risk assessments for terrestrial vertebrates, aquatic organisms, honeybees, non-target arthropods, earthworms, soil macro-organisms and organic matter breakdown, soil micro-organisms and non-target terrestrial plants indicate that no adverse short-term or long-term effects on these species are to be expected from the use of BIX + FLU + PTZ EC 260 according to the proposed use pattern. Reference is made to the previous assessment from the Ctgb (application number 20170965 NLWERGZ, approved by the Ctgb in January 2018).
3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
Birds
Effects on birds for BIX + FLU + PTZ EC 260 were not evaluated as part of the EU review of neither bixafen, fluopyram nor prothioconazole. The risk assessment showed that all toxicity-to-exposure-ratios (TER, including combitox) for birds meet the trigger. Thus, an unacceptable risk to birds from dietary exposure after use of the product as described in this dossier is unlikely.
No risk to birds resulted from exposure via drinking water, and the risk from secondary poisoning is considered to be low.
Terrestrial vertebrates (other than birds)
Effects on terrestrial vertebrates other than birds for BIX + FLU + PTZ EC 260 were not evaluated as part of the EU review of neither bixafen, fluopyram nor prothioconazole.
The acute and long term risk (including combitox) to herbivorous mammals exposed to the active substances following application of the product is considered to be low. For the metabolite JAU 6476- desthio, the TER calculations based on more realistic assumptions (higher tier risk assessment) indicate a low risk for small and large herbivorous mammals as well.
No risk to mammals resulted from exposure via drinking water, and the risk from secondary poisoning is considered to be low.
3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)
Effects on aquatic species for BIX + FLU + PTZ EC 260 were not evaluated as part of the EU review of neither bixafen, fluopyram nor prothioconazole. Additional studies on the formulation are provided.
The TER values for fluopyram, prothioconazole and the prothioconazole metabolites JAU 6476-S-methyl and 1,2,4-triazole meet all required triggers for acute and chronic risk (including combitox), indicating an acceptable risk to aquatic organisms for the use of the product in cereals.
3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)
Bees
Effects on bees for BIX + FLU + PTZ EC 260 were not evaluated as part of the EU review of neither bixafen, fluopyram nor prothioconazole. Additional studies on the formulation are provided. Risk assessments for BIX + FLU + PTZ EC 260 with the proposed use pattern were provided and are considered adequate.
The risks of BIX + FLU + PTZ EC 260 to honey-bees was assessed from hazard quotients between toxicity endpoints, estimated from acute oral and contact studies with active ingredient and formulated product.
All the hazard quotients are considerably less than 50, indicating that the active ingredients pose a low risk to bees. Therefore a low risk to bees is expected from the application of BIX + FLU + PTZ EC 260 according to the recommended use pattern.
Other non-target arthropods
Effects on non-target arthropods for BIX + FLU + PTZ EC 260 were not evaluated as part of the EU review of neither bixafen, fluopyram nor prothioconazole. Additional studies on the formulation were provided. The risk assessment indicated that no unacceptable adverse effects on non-target arthropods are to be expected for the in- or off-field habitats following the use of the product according to the proposed use pattern.
3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6)
Effects on earthworms and other soil macro-organisms for BIX + FLU + PTZ EC 260 were not evaluated as part of the EU review of neither bixafen, fluopyram nor prothioconazole. Additional studies on the formulation were provided.
Earthworms
As demonstrated by acute and chronic studies provided in the core document, no unacceptable acute or chronic effects on earthworms are to be expected from the application of the product BIX + FLU + PTZ EC 260 according to the proposed use pattern. The risk is considered acceptable.
Effects on other soil non-target macro-organisms
The tests with collembola and Hypoaspis also indicate that no adverse effects on other soil non-target macro-organisms are to be expected from the use of the product BIX + FLU + PTZ EC 260 according to the proposed use pattern. The risk is considered acceptable.
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6)
A study on the organic matter breakdown is not required for prothioconazole based on the DT90f value of this active substance and acceptable TER values for earthworms, soil macro-organisms and/or soil micro- organisms.
Nevertheless, litter bag studies are available with the lead formulations for all three active substances, bixafen, fluopyram and prothioconazole.
According to these studies, bixafen, fluopyram and prothioconazole do not present any significant risk for organic matter breakdown.
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
Effects on soil non-target micro-organisms for BIX + FLU + PTZ EC 260 were not evaluated as part of the EU review of neither bixafen, fluopyram nor prothioconazole. Additional data have been provided on the formulation and one metabolite.
The risk assessment indicated that no adverse effects on soil micro-organisms are to be expected when the product is applied according to the proposed use pattern.
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8)
Non-Target Plants
Effects on non-target plants for BIX + FLU + PTZ EC 260 were not evaluated as part of the EU review of neither bixafen, fluopyram nor prothioconazole. Additional data have been provided on the formulation. The risk assessment indicated that no adverse effects on terrestrial non-target plants are to be expected when the product is applied according to the proposed use pattern.
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 in Point 10.2 to 10.8 of this 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)
This application concerns a label extension of Ascra Xpro (15543 N) for the use in winter & spring barley and in oats. Ascra Xpro is a fungicide formulated as an Emulsion Concentrate (EC) containing the following three active substances: bixafen (65 g/L), fluopyram (65 g/L) and prothioconazole (130 g/L).
Ascra Xpro is currently authorized, by means of mutual recognition, for the use in (winter & spring) wheat, (winter & spring) rye, triticale and spelt to control a range of (major) cereal fungal diseases at a rate of 1.5 liter product per hectare. Ascra Xpro can only be applied once per season in these cereals.
All the data regarding the efficacy of the product for the new uses have been submitted in the bio dossier. These data demonstrate that Ascra Xpro fulfils all criteria for the authorization of preparations described in Directive 97/57/EC (Uniform Principles, Annex VI to Directive 91/414/EEC).
Justification of the association
Data generated in barley to demonstrate the benefits of the association of fluopyram to bixafen and prothioconazole, when applied as an EC 260 co-formulation, showed that the association contributes to an extra activity against Puccinia hordei, Pyrenophora teres and Ramularia collo-cygni.
In addition, data generated in wheat were presented which showed the benefits of the association against Erysiphe graminis, Septoria tritici and Pyrenophora tritici-repentis in wheat, which was already concluded in the core dossier at the basis of the mutual recognition for the use of Ascra Xpro in wheat, rye, triticale and spelt.
Minimum Effective Dose
For MED-justification in barley and oats a total of 67 MED-trials were submitted. Trials were conducted in 2012 and 2013 in the Maritime EPPO Climatic Zone (50 trials, BE [4], CZ [3], FR [24], DE [10] & UK [9]) and in the North-East Climatic Zone (17 trials in PL). All MED-trials were conducted in barley on a range of fungal diseases such as Net blotch, Pyrenophora teres, PYRNTE (38 trials); Powdery mildew, Blumeria graminis, ERYSGR (20 trials); Leaf scald, Rhynchosporium commune & Rhynchosporium secalis, RHYNCO & RHYNSE (24 trials) and Brown / Dwarf rust, Puccinia hordei, PUCCHD (11 trials). In all MED-trials the proposed label rate of 1.2 L/ha and the 0.6N dosage (0.72 L/ha) were tested.
Based on the generated data in the MED-trials, it can be concluded that the intended dose rate of 1.2 L/ha is the appropriate Minimum Effective Dose for adequate control of a range of fungal diseases in barley and oats.
Efficacy
For justification of the efficacy against a range of fungal diseases in comparison to currently authorized reference standards a total of 85 valid efficacy trials in barley and 4 in oats were submitted.
Barley
Trials in barley were conducted between 2012 and 2015 in the Maritime EPPO Climatic Zone (63 trials, BE [7], CZ [3], DK [1], FR [28], DE [14], UK [10], in the North-East EPPO Climatic Zone (19 trials, LV [4], LT [1] & PL [14]) and in the South-East EPPO Climatic Zone (3 trials in SK).
In the barley trials, efficacy was determined on the following fungal diseases: Net blotch, Pyrenophora teres, PYRNTE (37 trials), Powdery mildew, Erysiphe graminis, ERYSGR (22 trials), Leaf blotch of cereals, Rhynchosporium secalis, RHYNSE (20 trials), Brown / Dwarf rust, Puccinia hordei, PUCCHD (17 trials), Ramularia leaf spot disease Ramularia collo-cygni, RAMUCC (10 trials) and Stem break of cereals, Pseudocercosporella herpotrichoides, PSDCHE (5 trials). The efficacy of Ascra Xpro was compared to the efficacy provided by reference products containing 150 g/L prothioconazole + 75 g/L bixafen or 233 g/L boscalid plus 67 g/L epoxiconazole.
The single application of 1.2 L/ha Ascra Xpro in the barley trials provided in average 91.3% efficacy against PYRNTE, 93.4% against ERYSCR, 91.8% against RHYNSE, 94.1% against PUCCHD, 95.4% against RAMUCC and 83.9% against PSDCHE. The observed efficacy by Ascra Xpro was superior to the efficacy achieved by the reference product containing boscalid + epoxiconazole and similar to slightly superior to the efficacy achieved by the reference product containing prothioconazole + bixafen.
Submitted number of trials is considered sufficient for evaluation. The efficacy is supported by the level of control of the claimed target diseases in barley in comparison with reference products. Therefore, the claimed use of 1.2 L/ha Ascra Xpro for the control of Pyrenophora teres, Erysiphe graminis, Rhynchosporium secalis, Puccinia hordei, Ramularia collo-cygni and Pseudocercosporella herpotrichoides can be approved.
Oats
Trials in oats were conducted in 2012 and 2013 in the Maritime EPPO Climatic Zone (2 DK trials & 2 FR trials). In the oat trials efficacy on Crown rust, Puccinia coronate, PUCCCA (3 trials) and Powdery mildew, Erysiphe graminis, ERYSPA (1 trial) was determined, and compared to the efficacy provided by a reference product containing 233 g/L boscalid plus 67 g/L epoxiconazole.
In oats, Ascra Xpro is claimed to control Puccinia coronate by a single application at a rate of 1.2 L/ha. In three trials, the single application of 1.2 L/ha Ascra Xpro provided in average 87.2% efficacy against Puccinia coronate which was comparable to the efficacy achieved by the reference product.
The number of trials is considered limited but acceptable as oats is a minor crop in NL, therefore the claimed use of 1.2 L/ha Ascra Xpro to control Puccinia coronate in oats can be approved.
As in the intended GAP the application timing between BBCH 30 and BBCH 61 is given, the following instruction of use will be place on the Dutch label:
Let op: In de teelt van wintertarwe, wintergerst, winterrogge, triticale, spelt, zomertarwe, zomergerst, zomerrogge en haver het middel toepassen van begin stengelstrekking (BBCH30 tot het begin van de bloei (BBCH 61).
Adverse effects on treated crops
Studies on phytotoxicity to host crops, yield and quality parameter have demonstrated that adverse effects on yield & quality of treated barley or oats crops can be considered highly unlikely.
In addition, specific studies demonstrated that adverse effects on plant parts destined for propagating procedures as well as adverse effects on the processing procedure of plant parts can also be considered as highly unlikely.
Observations on other undesirable or unintended side-effects
The provided studies performed for the extended use in barley and oats have shown that undesirable effects are not expected on succeeding crops and/or adjacent crops.
Resistance management
In the short period between the approval of Ascra Xpro by the mutual recognition and this application for label extension the risk for resistance development has not shifted. Therefore, reference is made to the previous evaluation and the instruction of use imposed on the current label will be taken over to the extended label:
Resistentiemanagement
Dit middel bevat de werkzame stoffen bixafen, fluopyram en prothioconazool. Bixafen en fluopyram behoren tot de Succinate dehydrogenase inhibitors (SDHI-fungiciden). De FRAC code is 7. Prothioconazool behoort tot de Demethylation Inhibitors (DMI-fungiciden). De FRAC code is 3. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.
3.2 Conclusions
An extension of the authorisation in oats, spring barley and winter barley can be granted.
3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation
No further information is required.
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Ascra Xpro Registration Report – Central Zone Page 35 of 58
Appendix 1 – Copy of the product label
Wettelijk Gebruiksvoorschrift
Het middel is uitsluitend toegelaten als schimmelbestrijdingsmiddel voor het professionele gebruik door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.1 , Ctgb juni 2015) onder de hierna vermelde toepassingsvoorwaarden.
Toepassingsvoorwaarden:
Toepassingsgebied | Werkzaamheid getoetst op | Dosering* middel per toepassing | Maximaal aantal toepassingen per teeltcyclus |
Wintertarwe | Aarfusarium1, Bladvlekkenziekte2, Bruine roest3, DTR4, Echte xxxxxxxx0, Gele roest6, Kafjesbruin7, Oogvlekkenziekte8, Scherpe-oogvlekkenziekte9, Sneeuwschimmel10 | 1,5 L/ha | 1 |
Wintergerst | Echte xxxxxxxx0, Oogvlekkenziekte8, Bladvlekkenziekte11, Dwergroest12, Netvlekkenziekte13, Ramularia14 | 1,2 L/ha | 1 |
Winterrogge | Bladvlekkenziekte11, Bruine roest3, Echte xxxxxxxx0, Oogvlekkenziekte8 | 1,5 L/ha | 1 |
Triticale | Aarfusarium1, Bladvlekkenziekte2,11, Bruine roest3, Echte xxxxxxxx0, Kafjesbruin7, Scherpe-oogvlekkenziekte9, Sneeuwschimmel10 | 1,5 L/ha | 1 |
Spelt | Aarfusarium1, Bladvlekkenziekte2,11, Bruine roest3, Echte xxxxxxxx0, Kafjesbruin7, Scherpe-oogvlekkenziekte9, Sneeuwschimmel10 | 1,5 L/ha | 1 |
Zomertarwe | Aarfusarium1, Bladvlekkenziekte2, Bruine roest3, DTR4, Echte xxxxxxxx0, Gele roest6, Kafjesbruin7, Oogvlekkenziekte8, Scherpe-oogvlekkenziekte9, Sneeuwschimmel10 | 1,5 L/ha | 1 |
Zomergerst | Echte xxxxxxxx0, Oogvlekkenziekte8, Bladvlekkenziekte11, Dwergroest12, Netvlekkenziekte13, Ramularia14 | 1,2 L/ha | 1 |
Zomerrogge | Bladvlekkenziekte11, Bruine roest3, Echte xxxxxxxx0, Oogvlekkenziekte8 | 1,5 L/ha | 1 |
Haver | Kroonroest15 | 1,2 L/ha | 1 |
* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. Werkzaamheid is vastgesteld voor de genoemde dosering per toepassing en niet voor verlaagde doseringen.
1 Aarfusarium (Fusarium spp. )
2 Bladvlekkenziekte (Septoria tritici)
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3 Bruine roest (Puccinia recondita)
4 DTR (Pyrenophora tritici-repentis)
5 Echte meeldauw (Blumeria graminis)
6 Gele roest (Puccinia striiformis)
7 Kafjesbruin (Septoria nodorum)
8 Oogvlekkenziekte (Pseudocercosporella herpotrichoides)
9 Scherpe-oogvlekkenziekte (Rhizoctonia cerealis)
10 Sneeuwschimmel (Microdochium nivale)
11 Bladvlekkenziekte (Rhynchosporium secalis)
12 Dwergroest (Puccinia hordei)
13 Netvlekkenziekte (Pyrenophora teres)
14 Ramularia (Ramularia collo-cygni)
15 Kroonroest (Puccinia coronata)
Overige toepassingsvoorwaarden
In de teelt van wintertarwe, winterrogge, triticale, spelt, zomertarwe en zomerrogge het middel toepassen in 100 tot 400 liter water per hectare.
Draag beschermende handschoenen bij werkzaamheden aan behandeld gewas.
Let op: In de teelt van wintertarwe, wintergerst, winterrogge, triticale, spelt, zomertarwe, zomergerst, zomerrogge en haver het middel toepassen van begin stengelstrekking (BBCH30) tot het begin van de bloei (BBCH 61).
Resistentiemanagement
Dit middel bevat de werkzame stoffen bixafen, fluopyram en prothioconazool. Bixafen en fluopyram behoren tot de Succinate dehydrogenase inhibitors (SDHI-fungiciden). De Frac code is 7. Prothioconazool behoort tot de Demethylation Inhibitors (DMI-fungiciden). De Frac code is
3. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.
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Ascra Xpro Registration Report – Central Zone Page 37 of 58
Appendix 2 – Letter of Access
Bayer CropScience own all data. For certain metabolite studies which were needed to address the relevance of the metabolite, BCS has a letter of co-ownership which can be made available upon request. A letter of access (M-405318-05-1) is provided to Bayer CropScience X.X.xx Bayer CropScience AG is the owner of all studies.
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Appendix 3 – List of references
The mammalian toxicology assessment is fully covered by the original authorization 15543 N (application number 20170965NLWERGZ, approved by Ctgb in January 2018).
Applicant: Bayer Crop Science Evaluator: Ctgb
Date: September 2018
Annex point/ reference No | Author(s) | Year | Title Source (where different from company) Report-No. GLP or GEP status (where relevant) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA 2.1 KIIIA 2.4.2 KIIIA 2.5.1 KIIIA 2.5.2 KIIIA 2.5.3 KIIIA 2.6.1 KIIIA 2.7.1 KIIIA 2.7.3 KIIIA 2.7.4 KIIIA 2.8.2 KIIIA 2.8.7.1 KIIIA 2.8.7.2 KIIIA 2.8.7.3 KIIIA 4.1.3 | Xxxxxxxx, X.; Xxxxx, X. | 2013 | Storage stability at elevated temperature and cold stability of bixafen + fluopyram + prothioconazole EC 260 (65+65+130 g/L) - Packaging material: COEX/EVOH - Final report (14 days) - BIX+FLU+PTZ EC 260 (65+65+130) G Report No.: FM0183(PKF03)G01, Edition Number: M-468936-01-1 GLP/GEP: yes, unpublished | Y | Y | Bayer CropScience |
KIIIA 2.2.1 KIIIA 2.2.2 KIIIA 2.3.1 KIIIA 2.3.3 | Xxxxxxxxx, H. P. | 2013 | Safety-relevant data of bixafen + fluopyram + prothioconazole EC 260 (65+65+130 g/L) Bayer Technology Services GmbH, Leverkusen. Germany Report No.: 2013/00657, Edition Number: M-462429-01-1 GLP/GEP: yes, unpublished | Y | Y | Bayer CropScience |
KIIIA 2.4.2 KIIIA 2.5.1 KIIIA 2.5.2 KIIIA 2.5.3 KIIIA 2.6.1 KIIIA 2.7.1 KIIIA 2.7.3 KIIIA 2.7.4 KIIIA 2.8.2 KIIIA 2.8.7.1 KIIIA 2.8.7.2 KIIIA 2.8.7.3 KIIIA 4.1.3 | Xxxxxxxx, X.; Xxxxx, X. | 2013 | Storage stability at elevated temperature and cold stability of bixafen + fluopyram + prothioconazole EC 260 (65+65+130 g/L) - Packaging material: COEX/PA - Final report (14 days) - BIX+FLU+PTZ EC 260 (65+65+130) G Report No.: FM0183(PKF02)G01, Edition Number: M-468934-01-1 GLP/GEP: yes, unpublished | Y | Y | Bayer CropScience |
KIIIA1 2.7.5 | Xxxxxxxx, X.; Xxxxx, X. | 2015 | Shelf life of bixafen + fluopyram + prothioconazole EC 260 Packaging material: Coex/PA final report Report No.: M-541863-01-1 FM0183(SLF02)G01 GLP: yes, unpublished | Y | Y | Bayer CropScience |
KIIIA1 2.7.5/02 | Xxxxxxxx, X.; Xxxxx, X. | 2015 | Shelf life of bixafen + fluopyram + prothioconazole EC 260 Packaging material: Coex/EVOH final report Report No.: M-541914-01-1 FM0183(SLF03)G01 GLP: yes, unpublished | Y | Y | Bayer CropScience |
KIIIA1 2.7.5/03 | Xxxxxxxx, X.; Xxxxx, X. | 2016 | Content of active substances and relevant impurity JAU6476-desthio before and after storage for 6 month at ambient temperature … final report (6 month) Report No.: M-555918-01-1 FM0183(STM00)N01 GLP: yes, unpublished | Y | Y | Bayer CropScience |
KIIIA1 2.7.5/04 | Xxxxxx, X.; Xxxxx- Xxxxxx, X. | 2016 | Bixafen+fluopyram+prothioconazole EC 260 2-year storage shelf life at ambient temperature Statement M-570249-01-1 GLP: no, unpublished | Y | N | Bayer CropScience |
KIIIA 4.2.2 /01 | Xxxxxxxxxxx , X. | 2008 | Summary and conclusive report of studies on spray tank cleaning realized in the years 2000 - 0000 Xxxxxxxxxxx Xxxxxx Inc., Report No.: M-357166-01-1, Edition Number: M-357166-01-1 GLP/GEP: n.a., unpublished | Y | N | Bayer CropScience |
KIIIA 5.2.2 /01 | Xxxxxx, X. | 2012 | Determination of bixafen, fluopyram and prothioconazole in formulations ; Assay - HPLC, external standard Report No.: AM018212MF2, Edition Number: M-430584-02-1 GLP/GEP: no, unpublished | Y | N | Bayer CropScience |
KIIIA 5.2.2 /02 | Xxxxxx, X. ; Xxxxxx, X. | 2013 | Validation of HPLC-method AM018212MF2 - Determination of bixafen, fluopyram and prothioconazole in formulations - bixafen + fluopyram + prothioconazole EC 260 (65+65+130 g/L) Report No.: VB1-AM018212MF2, Edition Number: M-460510-01-1 GLP/GEP: Yes, unpublished | Y | Y | Bayer CropScience |
KIIIA 5.2.4 /01 | Xxxxxx, X. | 2001 | Determination of prothioconazole-desthio (SXX 0665) in formulations - Assay HPLC- MS/MS, external standard - Amendment no. 1 - Previous report number: M-078059-02-1 Report No.: 0000-0000000-00, Edition Number: M-450152-01-1 GLP/GEP: no, unpublished | Y | N | Bayer CropScience |
KIIIA 5.2.4 /02 | Xxxxxx, X. ; Xxxxxx, X. | 2013 | Validation of HPLC-MS/MS -method 0000-0000000-00 - Determination of prothioconazole-desthio in formulations - bixafen + fluopyram + prothioconazole EC 260 (65+65+130 g/L) Report No.: VB45-2001-0051702, Edition Number: M-458207-01-1 GLP/GEP: Yes, unpublished | Y | Y | Bayer CropScience |
KIIIA 5.2.4 /03 | Xxxxxx, X. | 2008 | Determination of the impurity toluene in formulations ; assay - GLC, internal standard Report No.: AM012408MF2, Edition Number: M-319820-02-1 GLP/GEP: no, unpublished | Y | N | Bayer CropScience |
KIIIA 5.2.4 /04 | Xxxxxx, X. ; Xxxxxx, X. | 2013 | Validation of GLC-method AM015911MF1 - Determination of the impurity toluene in formulations - bixafen + fluopyram + prothioconazole EC 260 (65+65+130 g/L) Report No.: VB20-AM015911MF1, Edition Number: M-460509-01-1 GLP/GEP: Yes, unpublished | Y | Y | Bayer CropScience |
KIIA 4.3 | Xxxxxxxxxxx, X. | 2008 | Independent laboratory validation of the analytical method 01063 for the determination of residues of BYF00587 and its metabolite BYF00587-desmethyl in/on animal tissues, milk and eggs by HPLC- MS/MS 01063 ! MR-08/004 ! 07-09 ! M-296906-01-1 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxxxxxxxx, X.; Xxxxxx, X. | 2008 | Independent laboratory validation of the analytical method 00983 for the determination of residues of BYF 00587 in/on plant matrices by HPLC-MS/MS 00983 ! MR-08/005 ! 07-07 ! M-296264-01-1 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxxx, X.; Xxxxxxxx, X. | 2006 | Analytical method 00983 for the determination of residues of BYF00587 in/on plant matrices by HPLC-MS/MS (incl. amendment No. 1 dated 2007-09-06) 00983 ! MR-06/029 ! P 622061004 ! M-276019-01-1 ! M-276019-02-1 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxxxx, X.; Xxxxxxx, X. | 2007 | Analytical method 01063 for the determination of residues of BYF00587 and its metabolite BYF00587- desmethyl in/on animal tissues, milk and eggs by HPLC-MS/MS (incl. amendment No. 1 dated 2008- 02-04) 01063 ! MR-07/279 ! P683070616 ! M-294142-01-1 ! M-294142-02-1 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxxxx, X.; Xxxxxxx, X. | 2006 | Analytical method 01009 for the determination of residues of JAU 6476-desthio, JAU 6476-3-hydroxy- desthio, JAU 6476-4-hydroxy-desthio, JAU 6476-3,4-dihydroxy-desthio, and JAU 6476-4,5- dihydroxy-desthio in/on matrices of animal origin by HPLC-MS/MS 01009 ! MR-06/120 ! P683061806 | Y | N | Bayer CropScience |
KIIA 4.3 | Class, T. | 2007 | Independent laboratory validation of DFG Method S 19 for the determination of residues of fluopyram (AE C656948) in plant material P 1351 G ! X/X 0000 X ! P612077509 ! M-293940-01-2 | Y | N | Bayer CropScience |
KIIA 4.3 | Class, Th. | 2001 | Independent laboratory validation of DFG method S19 (extended revision) for the determination of residues of JAU 6476-desthio (Bayer method 00086/M033) in plant materials P 484 G ! X/X 000 X ! MO-01-010487 ! M-033019-01-1 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxx, X. | 2001 | Independent laboratory validation of Bayer methods 00655 and 00655/M001 for the determination of residues of JAU6476-3-hydroxy-desthio, JAU6476-4-hydroxy-desthio, and JAU6476-desthio in/on matrices of animal origin by HPLC-MS/MS A-14-01-01 ! MO-01-020167 ! M-081595-01-1 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxxxx, X. | 2007 | Analytical method 00655/M002 for the determination of residues of JAU6476-desthio, JAU6476-3- hydroxy-desthio and JAU6476-4-hydroxy-desthio in/on matrices of animal origin by HPLC-MS/MS 00655/M002 ! MR-06/199 ! P 000 00 0000 ! M-284607-01-1 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxxxxxx, X. | 2001 | Analytical determination of residues of JAU6476-3-hydroxy-desthio, JAU6476-4-hydroxy-desthio, and JAU6476-desthio in/on matrices of animal origin by HPLC-MS/MS (Method-No. 00655) 00655 ! MR-537/00 ! P603003006 ! MO-01-002620 ! M-037709-01-1 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxxxxxx, X. | 2001 | Analytical determination of residues of JAU6476-3-hydroxy-desthio, JAU6476-4-hydroxy-desthio, and JAU6476-desthio in milk by HPLC-MS/MS (00655/M001) 00655/M001 ! MR-170/01 ! P603013001 ! MO-01-009555 ! M-021546-01-1 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxxx, M. | 2008 | Independent laboratory validation of the analytical method 01079 for the determination of residues of fluopyram (AE C656948) and AE F148815 in/on animal tissues, eggs and milk by HPLC-MS/MS MR-08/053 ! 08-02 ! M-299473-01-2 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxxx, S.; Xxxxxxxxx, X. | 2007 | Validation of DFG method S 19 (L 00.00-34) for the determination of fluopyram (AE C656948) in plant matrices P682077508 ! BAY-0706V ! G07-0121 ! M-292714-01-2 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxxxxx, X.; Xxxxxxx, X. | 2008 | Analytical method 01079 for the determination of residues of fluopyram (AE C656948) and AE F148815 in/on animal tissues, eggs and milk by HPLC-MS/MS MR-07/348 ! P683074742 ! M-296867-01-2 ! 01079 | Y | N | Bayer CropScience |
KIIA 4.3 | Sur, R.; Xxxxxx, X.; Xxxxxx, X. | 2007 | Extraction efficiency testing of the residue method for the determination of BYF 00587 and BYF 00587-desmethyl using aged radioactive residues from a wheat metabolism study MEF-07/356 ! M9991593-5 ! M-294920-01-1 | Y | N | Bayer CropScience |
KIIA 4.3 | Xxxxxx, R. D.; Xxxx, X. | 2000 | Validation of DFG method S 19 (extended revision) for the determination of residues of JAU 6476- desthio in materials of plant and animal origin (Method-No. 00086/M033) 00086 / M033 ! BAY-0005V ! G00-0033 ! MO-00-016073 ! M-027637-01-1 | Y | N | Bayer CropScience |
KIIA 4.3, KIIA 6.3 | Xxxxxxx, D. R. | 2008 | AE C656948 500 SC - Magnitude of the residue in/on fruiting vegetables (crop group 8 ) RAGMP041 ! M-299989-01-1 GLP: Open Published: Open | Y | N | Bayer CropScience |
KIIA 4.3, KIIIA1 5.3.1 | Xxxxxx, X. | 2006 | Independent laboratory validation of Bayer CropScience method No. 01009 for the determination of residues of JAU 6476-desthio, JAU 6476-3-hydroxy-desthio, JAU 6476-4-hydroxy-desthio, JAU 6476- 3,4-dihydroxy-desthio, and JAU 6476-4,5-... P 1111 G ! M-279818-01-1 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2189121, BVL-2629862, ASB2011-13494 | Y | N | Bayer CropScience |
KIIA 4.3, KIIIA1 5.3.1 | Brumhard, B.; Xxxxx, X. | 2007 | Analytical method 01013 for the simultaneous determination of residues of the active items BYF00587, prothioconazole, tebuconazole, trifloxystrobin and the metabolites BYF00587-desmethyl, JAU6476- desthio (SXX0665) and CGA321113 in/on plant material by HPLC-MS/MS (incl. amendment No. 0001 dated 2007-08-23 and amendment No. 0002 dated 2008-02-18) 01013 ! MR-06/138 ! P 602 065523 ! M-283439-01-1 ! M-283439-02-1 ! M-283439-03-1 GLP: Open (2) Yes (1) Published: No (1) Open (2) | Y | N | Bayer CropScience |
KIIA 4.3, KIIIA1 5.3.1 | Xxxxxxx, X.; Xxx, X. | 2013 | Analytical method 01009 for the determination of residues of JAU 6476-desthio,JAU 6476-3-hydroxy- desthio, JAU 6476-4-hydroxy-desthio, JAU 6476-3,4- dihydroxy-desthio, and JAU 6476-4,5- dihydroxy-desthio in/on matrices of animal origin by HPLC-MS/MS - Amendment no. 1 - incl. report dated 26.10.2006 MR-06/120 ! M-279725-02-1 ! X 000 00 0000 XXX: Open (1) Yes (1) Published: No (1) Open (1) BVL-2456930, BVL-2629861, ASB2013-9506 | Y | N | Bayer CropScience |
KIIA 4.3, KIIIA1 5.3.1 | Schwarz, T.; Class, T. | 2007 | Independent laboratory validation of Bayer CropScience method 00655/M002 for the determination and confirmation of residues of JAU6476-desthio, JAU6476-3-hydroxy-desthio and JAU6476-4- hydroxy-desthio in/on matrices of animal origin by HPLC-MS/MS P 1226 G ! X/X 0000 X ! P613060603 ! M-286824-01-1 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2189086, BVL-2629864, ASB2008-276 | Y | N | Bayer CropScience |
KIIA 4.4 | Xxxxxxxx, B.; Xxxxxxxxx, X. | 2008 | Analytical Method 01068 for the determination of residues of AE C656948 in soil by HPLC-MS/MS 01068 ! P681071820 ! MR-07/319 ! M-296215-01-2 | Y | N | Bayer CropScience |
KIIA 4.4 | Xxxxxxxx, X. | 2000 | Residue analytical method 00610 (MR-643/99) for the determination of JAU6476 and the metabolites JAU6476-desthio and JAU6476-S-methyl in soil by HPLC-MS/MS 00610 ! MR-643/99 ! P60190026 ! MO-00-010405 ! M-041798-01-1 | Y | N | Bayer CropScience |
KIIA 4.4 | Xxxxxxxxxx, X. | 2001 | Enforcement method 00086/M038 for the determination of the residues of JAU 6476-desthio in soil - Validation of DFG method S 19 (extended revision) - 00086/M038 ! BAY-0107V ! G01-0026 ! MO-01-015298 ! M-067970-01-1 | Y | N | Bayer CropScience |
KIIA 4.4, KIIA 4.6 | Xxxxxxxx, B.; Xxxxxxx, Xx. | 2006 | Analytical method 00959 for the determination of residues of BYF00587 in soil by HPLC-MS/MS 00959 ! MR-140/05 ! P681050015 ! M-281595-01-1 GLP: Open Published: Open | Y | N | Bayer CropScience |
KIIA 4.4, KIIIA1 5.4 | Brumhard, B. | 2005 | Modification M001 of method 00610 for the determination of JAU6476 and the metabolites JAU6476- desthio and JAU6476-S-methyl in soil by HPLC-MS/MS MR-183/04 ! 00610 M001 ! 00610/M001 ! P681040016 ! MO-05-001933 ! M-243729-01-1 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2189109, BVL-2629865, MET2005-358 | Y | N | Bayer CropScience |
KIIA 4.5 | Xxxxxxx, X.; Xxxxxx, X. | 2008 | Analytical method 01073 for the determination of bixafen (BYF 00587) in drinking and surface water by HPLC-MS/MS 01073 ! MR-07/336 ! P 684 077020 ! M-296389-01-1 | Y | N | Bayer CropScience |
KIIA 4.5 | Xxxxxxxxx, R. J. | 2008 | Independent laboratory validation of analytical method 01051 for the determination of fluopyram (AE C656948) in drinking and surface water by HPLC-MS/MS RAGMP087-1 ! M-298722-02-1 | Y | N | Bayer CropScience |
KIIA 4.5 | Xxxxxx, X. | 2001 | Enforcement method 00684 for determination of JAU6476 and JAU6476-desthio in drinking and surface water by HPLC-MS/MS 00684 ! MR-105/01 ! P 684 007002 ! MO-01-019621 ! M-079449-01-1 | Y | N | Bayer CropScience |
KIIA 4.5, KIIIA1 5.6 | Brumhard, B. | 2005 | Modification M001 of method 00684 for the determination of JAU6476 and JAU6476-desthio in drinking and surface water by HPLC-MS/MS MR-184/04 ! 00684 M001 ! 00684/M001 ! P684047047 ! MO-05-001939 ! M-243734-01-1 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2189094, BVL-2629866, MET2005-359 | Y | N | Bayer CropScience |
KIIA 4.7 | Xxxxxx, X. | 2008 | Fluopyram: Analytical method for determination in air P605087512 ! M-296842-01-1 | Y | N | Bayer CropScience |
KIIA 4.7 | Class, Th. | 2007 | BYF 00587: Analytical method for the determination of BYF 00587 in air P 1243 G ! X/X 0000 X ! P605077505 ! M-289587-01-1 | Y | N | Bayer CropScience |
KIIA 4.7 | Xxxxxxxx, X. | 2002 | Method for the determination of JAU 6476 in air by HPLC-MS/MS (Method-No. 00724) 00724 ! P 605 00 6005 ! MR-601/01 ! MO-02-001202 ! M-032554-01-1 | Y | N | Bayer CropScience |
KIIA 4.7 | Xxxxxxxx, X. | 2002 | Method for the determination of JAU 6476-desthio (SXX 0665) in air by HPLC-MS/MS (Method-No. 00731) MR-003/02 ! 00731 ! P 605 00 6012 ! MO-02-002585 ! M-036729-01-1 | Y | N | Bayer CropScience |
KIIA 6.2.1 | Xxxx, X. | 2001 | Extraction efficiency testing of the residue method (00647) for the determination of JAU6476 residues in spring wheat using aged radioactive residues MR-084/01 ! MO-01-011835 ! M 9991102-1 | Y | N | Bayer CropScience |
KIIA 6.2.2 | Xxxxxx, X.; Xxxxxxx, X. | 2008 | Metabolism of [phenyl-UL-14C]AE C656948 in the laying hen MEF-06/329 ! M01819173 ! M-297093-01-2 | Y | N | Bayer CropScience |
KIIA 6.2.3 | Xxxxxxx, X.; Xxxxxxx, X. | 2007 | Metabolism of [pyrazole-5-14C]BYF 00587 in the lactating goat MEF-06/316 ! M51819178 ! M-296034-01-1 GLP: Open Published: Open | Y | N | Bayer CropScience |
KIIA 6.2.3 | Xxxxx, X.; Xxxxx, X.; Xxxxxxx, X. | 2002 | [Phenyl-UL-14C]JAU6476-desthio: Absorption, distribution, excretion, and metabolism in the lactating goat including the validation of the residue analytical method for the determination of JAU6476- desthio, JAU6476-3-hydroxy-desthio and JAU6476-4-hydroxy-desthio residues in animal matrices using aged radioactive residues MR-091/01 ! Part 2 - MO-02-003998 ! M91819091 | Y | N | Bayer CropScience |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not | Data protection claimed | Data protection granted | Owner |
KIIIA 8.3.1 /01 | Xxxxxxxx, X. | 2013 | Determination of the residues of AE C656948 and prothioconazole in/on spring barley and winter barley after spray application of AE C656948 & JAU 6476 SE 250 in the field in northern France, Germany, the Netherlands, Belgium and United Kingdom Bayer CropScience, Report No.: 12-2163, Report includes Trial Nos.: 00-0000-00 00-0000-00 00-0000-00 00-0000-00 00-0000-00 00-0000-00 00-0000-00 00-0000-00 Edition Number: M-472556-02-1 Date: 2013-12-10 ...Amended: 2014-01-09 GLP/GEP: yes, unpublished | Yes | Yes | Bayer Crop Science |
KIIIA 8.3.1 /02 | Xxxxxxxx, X. | 2014 | Determination of the residues of AE C656948, BYF 00587 and prothioconazole in/on spring barley and winter barley after spray application of bixafen & fluopyram & prothioconazole EC 260 in the field in northern France, the United Kingdom, Belgium and Germany Bayer CropScience, Report No.: 12-2130, Report includes Trial Nos.: 00-0000-00 00-0000-00 00-0000-00 00-0000-00 Edition Number: M-475081-02-1 Date: 2014-01-22 ...Amended: 2014-03-31 GLP/GEP: yes, unpublished | Yes | Yes | Bayer Crop Science |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not Authority registration No./JKI-No. | Vertebrate study (J=Yes O=Open N=No) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA1 3.9 | 2014 | Proposed label for the plant protection product Ascra Xpro (BAY 21070 F) - BIX+FLU+PTZ EC 260 Ascra Xpro (BAY 21070 F) BIX+FLU+PTZ_EC260 (Bixafen 65 g/L+ Fluopyram 65 + Prothioconazole 130 g/L) | N | Y | Y | Bayer Crop Science | |
M-485228-01-1 | |||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629841/381606 | |||||||
KIIIA1 3.9 | 2014 | Proposed label for the plant protection product Ascra Xpro (BAY 21070 F) - BIX+FLU+PTZ EC 260 Ascra Xpro (BAY 21070 F) BIX+FLU+PTZ_EC260 (Bixafen 65 g/L+ Fluopyram 65 + Prothioconazole 130 g/L) | N | Y | Y | Bayer Crop Science | |
M-485228-01-1 | |||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629842/381607 | |||||||
KIIIA1 | 2001 | Results of JAU 6476 in the primary and secondary screening against | N | Y | Y | Bayer | |
6.1.1 | different fungal diseases in monocots and dicots | Crop | |||||
M-032406-01-1 | Science | ||||||
BAY | |||||||
N/N | |||||||
N | |||||||
2629868/381609 |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not Authority registration No./JKI-No. | Vertebrate study (J=Yes O=Open N=No) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA1 | 2007 | Results of bixafen in the primary and secondary screening against | N | Y | Y | Bayer | |
6.1.1 | different fungal diseases in monocots and dicots | Crop | |||||
M-295435-01-1 | Science | ||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629869/381610 | |||||||
KIIIA1 | 2008 | Results of fluopyram in the primary and secondary screening against | N | Y | Y | Bayer | |
6.1.1 | different fungal diseases in monocots and dicots | Crop | |||||
M-309069-01-1 | Science | ||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629870/381611 | |||||||
KIIIA1 | 2014 | Preliminary range finding tests bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.1.1 | 260 EC (065+065+130 g/l) - Preliminary dose response / mixture | Crop | |||||
justification M-480323-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629871/381612 | |||||||
KIIIA1 | 2014 | Justification of the mixture (ratio justification) bixafen & fluopyram & | N | Y | Y | Bayer | |
6.1.1 | prothioconazole EC 260 (065+065+130 g/l) | Crop | |||||
M-477822-01-1 | Science | ||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629872/381613 |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not Authority registration No./JKI-No. | Vertebrate study (J=Yes O=Open N=No) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA1 | 2014 | Justification of the mixture bixafen + fluopyram + prothioconazole 260 | N | Y | Y | Bayer | |
6.1.1 | EC (065+065+130 g/l) - Justification of the a.s. ratio | Crop | |||||
M-480324-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629873/381614 | |||||||
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.1.2 | EC 65+65+130 g/L - Efficacy tests - Wheat (winter and spring) | Crop | |||||
M-484127-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629874/381615 | |||||||
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.1.2 | EC 65+65+130 g/L - Efficacy tests - Barley (winter and spring) | Crop | |||||
M-484128-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629875/381616 | |||||||
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.1.2 | EC 65+65+130 g/L - Efficacy tests - Triticale, rye, spelt and oats | Crop | |||||
M-484129-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629876/381617 |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not Authority registration No./JKI-No. | Vertebrate study (J=Yes O=Open N=No) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.1.3 | EC 65+65+130 g/L - Efficacy tests - Wheat (winter and spring) | Crop | |||||
M-484127-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629877/381618 | |||||||
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.1.3 | EC 65+65+130 g/L - Efficacy tests - Barley (winter and spring) | Crop | |||||
M-484128-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629878/381619 | |||||||
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.1.3 | EC 65+65+130 g/L - Efficacy tests - Triticale, rye, spelt and oats | Crop | |||||
M-484129-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629879/381620 | |||||||
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.1.4.1 | EC 65+65+130 g/L - Effects on yield quality and germination | Crop | |||||
M-484142-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629880/381621 |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not Authority registration No./JKI-No. | Vertebrate study (J=Yes O=Open N=No) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA1 | 2002 | Report to BBPA of pesticide evaluation malting and brewing trials with | N | Y | Y | Bayer | |
6.1.4.2 | barleys treated with UK756 and UK831 | Crop | |||||
M-043866-01-1 | Science | ||||||
BAY | |||||||
N/N | |||||||
N | |||||||
2629881/381622 | |||||||
KIIIA1 | 2007 | Malting and brewing trials with barley treated with BYF00587 | N | Y | Y | Bayer | |
6.1.4.2 | M-290407-01-1 | Crop | |||||
BCS | Science | ||||||
N/N | |||||||
N | |||||||
2629882/381623 | |||||||
KIIIA1 6.1.4.2 | 2014 | Compilation of trial report for BIX+FLU+PTZ 260 EC, FLU+PTZ SE 250, FLU EC 150 - (bixafen 65 g/L + fluopyram 65 g/L + prothioconazole 135 g/L) - (fluopyram 125 g/L + prothioconazole 125 g/L) - (fluopyram 150 g/L) - Effects on the processing procedure: Ma | N | Y | Y | Bayer Crop Science | |
M-481773-01-1 | |||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629883/381624 | |||||||
KIIIA1 | 2014 | Final report on malting and brewing trials of the cereal fungicide | N | Y | Y | Bayer | |
6.1.4.2 | fluopyram | Crop | |||||
M-484758-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629884/381625 |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not Authority registration No./JKI-No. | Vertebrate study (J=Yes O=Open N=No) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA1 | 2005 | Proline - Dossier Biologique (Tome I/III) | N | Y | Y | Bayer | |
6.1.4.2 | M-277653-01-1 | Crop | |||||
BCS | Science | ||||||
N/N | |||||||
N | |||||||
2629885/381626 | |||||||
KIIIA1 | 2006 | Resulats d'analyses de qualite sur ble tendre - Recolte 2006 | N | Y | Y | Bayer | |
6.1.4.2 | M-293390-01-1 | Crop | |||||
BCS | Science | ||||||
N/N | |||||||
N | |||||||
2629886/381627 | |||||||
KIIIA1 | 2013 | Compilation of trial report for Fluopyram + prothioconazole SE 250 - | N | Y | Y | Bayer | |
6.1.4.2 | Bread making studies - Wheat - Sweden 2012 | Crop | |||||
M-460504-01-1 | Science | ||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629887/381628 | |||||||
KIIIA1 | 2014 | Compilation of trial report for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.1.4.2 | EC 260 - Bread making studies - Wheat - France 2013 | Crop | |||||
M-479925-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629888/381629 | |||||||
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.1.4.3 | EC 65+65+130 g/L - Effects on yield quality and germination | Crop | |||||
M-484142-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629889/381630 |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not Authority registration No./JKI-No. | Vertebrate study (J=Yes O=Open N=No) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA1 6.1 | 2014 | Summary of the efficacy data and information on the plant protection | N | Y | Y | Bayer | |
product for bixafen + fluopyram + prothioconazole EC 65+65+130 g/L - | Crop | ||||||
central zone M-484787-01-1 | Science | ||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629890/381631 | |||||||
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.2.1 | EC 65+65+130 g/L - Efficacy tests - Wheat (winter and spring) | Crop | |||||
M-484127-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629891/381632 | |||||||
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.2.1 | EC 65+65+130 g/L - Efficacy tests - Barley (winter and spring) | Crop | |||||
M-484128-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629892/381633 | |||||||
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.2.1 | EC 65+65+130 g/L - Efficacy tests - Triticale, rye, spelt and oats | Crop | |||||
M-484129-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629893/381634 |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not Authority registration No./JKI-No. | Vertebrate study (J=Yes O=Open N=No) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA1 | 2014 | Compilation of trial reports for bixafen + fluopyram + prothioconazole | N | Y | Y | Bayer | |
6.2.5 | EC 65+65+130 g/L - Effects on yield quality and germination | Crop | |||||
M-484142-01-1 | Science | ||||||
BCS | |||||||
N/J | |||||||
N | |||||||
2629894/381635 | |||||||
KIIIA1 | 2001 | Influence of JAU 6476 EC on non-target plants | X | X | X | Xxxxx | |
0.0.0 | X-000000-00-0 | Xxxx | |||||
XXX | Xxxxxxx | ||||||
X/X | |||||||
X | |||||||
2629895/381636 | |||||||
KIIIA1 | 2007 | Evaluation of the pre-emergence (PPI) biological activity of BYF 00587 | N | Y | Y | Bayer | |
6.2.6 | EC 125 G | Crop | |||||
M-295621-01-1 | Science | ||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629896/381637 | |||||||
KIIIA1 | 2007 | Evaluation of the pre-emergence (PPI) biological activity of AE | N | Y | Y | Bayer | |
6.2.6 | C656948 SC 500 | Crop | |||||
M-297136-01-1 | Science | ||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629897/381638 | |||||||
KIIIA1 | 2001 | Influence of JAU 6476 EC on non-target plants | N | Y | Y | Bayer | |
6.2.7 | M-043853-01-1 | Crop | |||||
BAY | Science | ||||||
N/N | |||||||
N | |||||||
2629898/381639 |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not Authority registration No./JKI-No. | Vertebrate study (J=Yes O=Open N=No) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA1 | 2007 | Evaluation of the post-emergence biological activity of BYF 00587 EC | N | Y | Y | Bayer | |
6.2.7 | 125 G | Crop | |||||
M-295623-01-1 | Science | ||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629899/381640 | |||||||
KIIIA1 | 2007 | Evaluation of the post emergence biological activity of AE C656948 SC | N | Y | Y | Bayer | |
6.2.7 | 500 | Crop | |||||
M-297155-01-1 | Science | ||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629900/381641 | |||||||
KIIIA1 6.2.8 | 2014 | Statement - Information on the occurrence or possible occurrence of the development of resistance of the plant protection product Ascra for use in cereals (for submission in Europe) - Bixafen 65 g/L + fluopyram 65 g/L + prothioconazole 130 g/L - EC 260 | N | Y | Y | Bayer Crop Science | |
M-483732-01-1 | |||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629901/381642 | |||||||
KIIIA1 6 | 2014 | Summary of the efficacy data and information on the plant protection | N | Y | Y | Bayer | |
product for bixafen + fluopyram + prothioconazole EC 65+65+130 g/L - | Crop | ||||||
central zone M-484787-01-1 | Science | ||||||
BCS | |||||||
N/N | |||||||
N | |||||||
2629902/381643 |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not Authority registration No./JKI-No. | Vertebrate study (J=Yes O=Open N=No) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA1 10.5.2 | 2014 | Effects of bixafen + fluopyram + prothioconazole EC 260 (65 + 65 + 130 g/L) on the parasitoid Aphidius rhopalosiphi, extended laboratory study - Dose response test M-480611-01-1 | N | Y | Y | Bayer Crop Science | |
BCS | |||||||
J/J | |||||||
N | |||||||
2629969/381653 | |||||||
KIIIA1 10.5.2 | 2014 | Effects of bixafen + fluopyram + prothioconazole EC 260 (65 + 65 + 130 g/L) on the predatory mite Typhlodromus pyri, extended laboratory study - Dose response test M-480613-01-1 | N | Y | Y | Bayer Crop Science | |
BCS | |||||||
J/J | |||||||
N | |||||||
2629970/381654 | |||||||
KIIIA1 10.5.2 | 2013 | Effects of bixafen + fluopyram + prothioconazole EC 260 (65 + 65 + 130 g/L) on the ladybird beetle Coccinella septempunctata, extended laboratory study - Dose response test M-476172-01-1 | N | Y | Y | Bayer Crop Science | |
BCS | |||||||
N/N | |||||||
N | |||||||
2629971/381655 | |||||||
KIIIA1 | 2013 | Effects of Bixafen + Fluopyram + Prothioconazole EC 260 (65 + 65 + | N | Y | Y | Bayer | |
10.5.2 | 130 g/L) on the lacewing Chrysoperla carnea, extended laboratory study | Crop | |||||
- Dose response test M-476030-01-1 | Science | ||||||
BCS | |||||||
J/J | |||||||
N | |||||||
2629972/381656 |
Annex point / reference number | Author(s) | Year | Title Source (where different from company) Company name, Report No., Date, GLP status (where relevant), Published or not Authority registration No./JKI-No. | Vertebrate study (J=Yes O=Open N=No) | Data protection claimed Y/N | Data protection granted Y/N | Owner |
KIIIA1 | 2013 | Bixafen+Fluopyram+Prothioconazole EC 260 (65+65+130 g/L) - On | N | Y | Y | Bayer | |
10.8.1.2 | vegetative vigour of terrestrial plants | Crop | |||||
M-476483-01-1 | Science | ||||||
BCS | |||||||
J/J | |||||||
N | |||||||
2629982/381659 | |||||||
KIIIA1 10.8.1.3 | 2014 | Effect of bixafen+fluopyram+prothioconazole EC 260 (65+65+130 g/L) - On the seedling emergence and seedling growth of terrestrial plants (Short code of test item: BIX+FLU+PTZ EC 260) M-478325-01-1 | N | Y | Y | Bayer Crop Science | |
BCS | |||||||
J/J | |||||||
N | |||||||
2629983/381660 |