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AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITYApplication Summary for Application No 105881

Created on: 05 Jul 2017 04:03 PM of 31 Application Summary 4

Application Details:

Application Purpose and Description of Use:

Registration of a 1g/kg aureobasidium pullulans wettable powder product to protect grapes from grey mould. In conjunction with 105885.

Active Constituent NameAUREOBASIDIUM PULLULANS

Reference Product Number Reference Product Name

82495Product No:

BOTECTOR FUNGICIDEProduct Name:

NUFARM AUSTRALIA LIMITEDApplicant Name:

Description of Data Provided

Data NoApplicants Reference Author Title Date Publication Authorising Party

Auth Party Contact Address

118854

120572

Project Plan v1

Appx 7.5_EFSA

D.Rumbold

Anonymous

Item 27 Timeshift Application Project Plan

Conclusion on the peer review of the pesticide risk assessment of the active substance Aureobasidium pullulans (strains DSM 14940 and DSM 14941).

4 February 2016

2013

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EFSA Journal 2013;11(4):3183

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Public

103-105 PIPE RD, LAVERTON NORTH, VIC 3026 AUSTRALIA

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120571

120570

120569

120568

120567

120566

Appx 7.4_IIM_1_3

Appx 7.21_TRY

Appx 7.22_AT2758-18

Appx 7.20_TRY

Appx 7.19_FEMS232

Appx 7.3_IIM_1_3

Strutzenberger K, Donat C, Ortmayr B

Daxner,B.

Knittl, P.

Pichler,E.

Campbell.


Tier 2 Summary of Further Information on the Microbial Pest Control Agent Aureobasidium pullulans (Strain DSM 14940). Annex IIM Section 1, Point 3 Document M. August 2015. bio-ferm Biotechnologische Entwicklung und Produktion GmbH

Test Report Yeast. Generated by: Quantas Analytics, Romer Labs Diagnostics Europe GmbH. A-3430 Tulln, Technopark 1.

Test Report AT-2758-1-8 - Analysis of fungal metabolites in culture materials of Aureobasidium pullulans. Generated by: Quantas Analytics, Romer Labs Diagnostics Europe GmbH. A-3430 Tulln, Technopark 1.


Which morphological forms of the fungus Aureobasidium pullulans are responsible for pullulan production?

Tier 2 Summary of Further Information on the Microbial Pest Control Agent Aureobasidium pullulans (Strain DSM 14941). Annex IIM Section 1, Point 3 Document M. August 2015. bio-ferm Biotechnologische Entwicklung und Produktion GmbH

August 2015

2011

2014

2011

2004

August 2015

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FEMS Microbiology Letters 232:225-228

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120565

120564

120573

120574

120575

120576

120586

120585

120584

120583

Appx 7.2_IIM_6_10

Appx 2.33_bfb

Appx 7.7_SM61

Appx 7.23_DD5

Appx 7.24_T52

Appx 7.25_AAC49

Appx 7.15_MM151

Appx 7.14_CJM48

Appx 7.13_ZPP101

Appx 7.10_AEM35

Strutzenberger K, Donat C, Ortmayr B (2015)

Donat C.

Zalar, P.

Fostel, J.M.

Kurome, T.

Sonda, S.

Chand-Goyal, T.

Andrews, J.H.

Falconi, C.J.

Webb, T.A.

Tier 2 Summary of the Ecological Studies on the Microbial Pest Control Product Blossom Protect. Annex IIM Section 6, Point 10 Document M. July 2015. bio-ferm Biotechnologische Entwicklung und Produktion GmbH

Storage stability Blossom Protect Component B at 8c Generated by: bio-ferm GmbH, Technopark 1B, 3430 Tulln

Redefinition of Aureobasidium pullulans and its varieties.Emerging novel antifungal agents.

Total synthesis of an antifungal cyclic depsipeptide aureobasidin A.Inhibitory Effect of Aureobasidin A on Toxoplasma gondii.

Enumeration of bacterial and yeast colonists of apple fruits and identification of epiphytic yeasts on pear fruits in the Pacific Northwest United States.

Population biology of Aureobasidium pullulans on apple leaf surfaces.

Epiphytic fungi on apple leaves and their value for control of the postharvest pathogen Botrytis cinerea, Monilia fructigena and Penicillium expansum.

Molds on vegetables at the time of harvest.

July 2015

2011

2008

2000

1996

2005

1996

2002

1994

1978

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Studies in Mycology 61: 2138.Drug Discovery Today 5:25-32Tetrahedron 52:4327-4346Antimicrob. Agents Chemother. 49:1794-1801.

Microbiological Research 151:427-432.

Canadian Journal for Microbiology 48:500-513.

Zeitschrift fr Pflanzenkrankheiten und Pflanzenschutz. 101:38-47

Appl. Environ. Microbiol. 35:655-658.

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120563

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Appx 2.32_bfa

Appx 7.8_A40Appx 7.11_JIMB30

Appx 7.31_LR

Appx 7.27_MR9

Appx 7.26_AEM60

Appx 7.12_MM41Appx 2.57_L1310BP14-0

Appx 2.34_L1310BP14

Donat C.

Kapyla, M.Punnapayak, H.

Donat, C.

Schrattenholz, A.

Mc Cormack, P.

Buzina, W.

Kunz S

Kunz S.

Storage stability Blossom Protect Component B at 20c Generated by: bio-ferm GmbH, Technopark 1B, 3430 Tulln.

Frame fungi on insulated windows.Characterization of Aureobasidium pullulans isolated from airborne spores in Thailand.

Literature review report on the environmental behaviour of Aureobasidium pullulans in water and sediment systems

Isolation, structural and toxicological characterization of three new mycotoxins produced by the fungus Aureobasidium pullulans.

Production of antibacterial compounds by phylloplane-inhabiting yeasts and yeastlike fungi.

Fungal biodiversity as found in nasal mucus.Interim Report: Storage stability of Blossom Protect after 24 months at 8 C Study code: L1310BP14 Trial / Lab Phase code: L1310BP14-01B08 Generated by: Bio-Protect GmbH, Lohnerhofstr.7, D-78467 Konstanz. 14 March 2016

Storage stability of the formulation Blossom Protect over 18 months at 20 C. Generated by: Bio-Protect GmbH, Lohnerhofstr.7, D-78467 Konstanz. Report No: L1310BP14

2011

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2012

1993

1994

2003

14 March 2016

2015

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Allergy 40:558-64.Journal of Indian Microbiology and Biotechnology 30:89-94

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Mycotoxin Research Vol.9:13-21.

Applied and Environmental Microbiology. 60:927-31

Med Mycol 41:149-61.-

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120560

120545

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Appx 2.36_ 06/262-355AN

Appx 2.39_20060875.01

Appx 2.38_20060875.03

Appx 2.37_09/213-338AN

Appx 2.31_IIIM_1_2_M

Appx 2.40_20060875.02

Kiss G.

Mller M.

Mller M.

Kiss G


Mller M.

Determination of the Relative Self-Ignition Temperature of Component B of Blossom Protect fb. Generated by: LAB International Research Centre Hungary Ltd., 8200 Veszprm, Szabadsgpuszta, Hungary Report No: 06/262-355AN

Component B of Blossom Protect fb Batch No.: 10405: Persistent Foaming (CIPAC MT 47). Generated by: Siemens AG, Prozess-Sicherheit, Industriepark Hoechst, C 487, D-65926 Frankfurt am Main, Germany Report No: 20060875.01

Component B of Blossom Protect fb Batch No.: 10405: Wettability (CIPAC MT 53). Generated by: Siemens AG, Prozess-Sicherheit, Industriepark Hoechst, C 487, D-65926 Frankfurt am Main, Germany Report No: 20060875.03

DETERMINATION OF THE pH VALUES OF COMPONENT B Generated by: LAB Research Ltd., Szabadsagpuszta, H-8200 Veszprem. Report No: 09/213-338AN

Tier 2 Summary of the Physical, Chemical and technical Properties of the Microbial Pest Control Product Blossom Protect. Annex IIIM Section 1, Point 2 Document M 29 July 2015

Component B of Blossom Protect fb Batch No.: 10405: Suspensibility (CIPAC MT 15, (161, 168)). Generated by: Siemens AG, Prozess-Sicherheit, Industriepark Hoechst, C 487, D-65926 Frankfurt am Main, Germany Report No: 20060875.02

2006

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2007

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29 July 2015

2007

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120541

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120537

120536

120540



Appx 7.37_DM

Appx 2.55_SDS14940

Appx 2.56_EJM43

Part 2_March 2016



Gty, S.

Anonymous

Anonymous

Leach, S

Tier 2 Summary of the Identity of the Microbial Pest Control Product Blossom Protect. Annex IIIM Section 1, Point 1 Document M 29 July 2015 bio-ferm Biotechnologische Entwicklung und Produktion GmbH

Tier 2 Summary of the Methods of Analysis, Manufacturing, Quality Control and Post-registration Monitoring of the Microbial Pest Control Product Blossom Protect. Annex IIIM Section 2, Point 5 Document M 29 July 2015 bio-ferm Biotechnologische Entwicklung und Produktion GmbH

REPRODUCTION TEST WITH BLOSSOM PROTECT (COMPONENT B) ON DAPHNIA MAGNA Generated by: LAB Research Ltd., Szabadsagpuszta, H-8200 Veszprem.

SAFETY DATA SHEET according to VO 1907/2006/EG, adapted by VO 453/2010/EG Aureobasidium pullulans DSM 14940

OECD Issue Paper on Microbial Contaminant Limits for Pest Control Products (ENV/JM/MONO(2011)43). Series on Pesticides. No.65

Part 2 Chemistry & Manufacture BOTECTOR FUNGICIDE DECISION ID: DC27-15101099 PAA ID Number:PAA-1445817890768 Item 27 submission

29 July 2015

29 July 2015

2009

17.04.2015

2011

March 2016

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ENV/JM/MONO(2011)43

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120587

120547

120549

120559

120558

120557

Appx 7.16_MOA

Appx 2.41_20060875.04

Appx 2.43_06/262-363AN

Appx 2.35_06/262-356AN

Appx 2.46_bpd

Appx 2.45_bpc

Kunz, S

Mller M.

Kiss G.

Kiss G.

Kunz S.

Kunz S.

Study on the mode of action of Aureobasidium pullulans (DSM14940 and DSM 14941) against the fire blight pathogen Erwinia amylovora. Generated by: Bio-protect, Lohnehoferstr. 7, D-78467 Konstanz

Component B of Blossom Protect fb Batch No.: 10405: Dispersibility (CIPAC MT 174). Generated by: Siemens AG, Prozess-Sicherheit, Industriepark Hoechst, C 487, D-65926 Frankfurt am Main, Germany Report No: 20060875.04

Determination of the Particle Size Distribution of Component B of Blossom Protect fb. Generated by: LAB International Research Centre Hungary Ltd., 8200 Veszprm, Szabadsgpuszta, Hungary Report No: 06/262-363AN

Determination of Flammability of Component B of Blossom Protect fb. Generated by: LAB International Research Centre Hungary Ltd., 8200 Veszprm, Szabadsgpuszta, Hungary Report No: 06/262-356AN

Persistent Foaming of the tank mixture of Blossom Protect together with the citric acid buffer Buffer Protect. Generated by: Bio-Protect GmbH, Lohnerhofstr.7, D-78467 Konstanz.

Suspensibility of the tank mixture of Blossom Protect together with the citric acid buffer Buffer Protect. Generated by: Bio-Protect GmbH, Lohnerhofstr.7, D-78467 Konstanz.

2007

2007

2006

2006

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120556

120548

120555

120553

120552

120551

120550

Appx 2.59_datalist1

Appx 2.42_06/262-342AN

Appx 2.58_draft label

Appx 2.49_bpg

Appx 2.48_bpf

Appx 2.47_bpe

Appx 2.44_20060875.05

Anonymous

Kiss G.

Anonymous

Kunz S.

Kunz S.

Kunz S.

Mller M.

Datalist_chemistry only

Wet Sieve Test of Component B of Blossom Protect fb. Generated by: LAB International Research Centre Hungary Ltd., 8200 Veszprm, Szabadsgpuszta, Hungary Report No: 06/262-342AN

Draft label - Botector E-Label

Free acidity and alkalinity of the tank mixture of Blossom Protect together with the citric acid buffer Buffer Protect Generated by: Bio-Protect GmbH, Lohnerhofstr.7, D-78467 Konstanz.

pH value of the tank mixture of Blossom Protect together with the citric acid buffer Buffer Protect Generated by: Bio-Protect GmbH, Lohnerhofstr.7, D-78467 Konstanz.

Dispersibility of the tank mixture of Blossom Protect together with the citric acid buffer Buffer Protect. Generated by: Bio-Protect GmbH, Lohnerhofstr.7, D-78467 Konstanz.

Component B of Blossom Protect fb Batch No.: 10405: Dustiness of Granules (CIPAC MT 171). Generated by: Siemens AG, Prozess-Sicherheit, Industriepark Hoechst, C 487, D-65926 Frankfurt am Main, Germany Report No: 20060875.05

30 March 2016

2007

2016

2015

2015

2015

2007

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120554

120588

120589

120590

128528

128527

128526

Appx 2.53_sdsbotector

Appx 7.17_SBC408

Appx 7.18_NYFQ10Appx 7.29_JAM

Appx 5.6_letter

Appx 5.9_247.V.SAG09/e

Appx 5.8_CEB-10-6405

Anonymous

Kunz, S

Goffinet, M.C.

Loncaric, I.

Donat, C

Ferrari, D.

Goyne, L.

Safety Data Sheet according to VO 1907/2006/EG, adapted by VO 453/2010/EG botector.

Fire blight control in organic fruit growing systematic investigation of the mode of action of potential control agents

Anatomy of apple russet caused by the fungus Aureobasidium pullulans.Strain-specific detection of two Aureobasidium pullulans strains, fungal biocontrol agents of fire blight by new developed multiplex PCR. .

Cover letter for confidential information provided to the APVMA from bio-ferm dated 23.02.16. Document J confidential information was provided under cover of this letter.

Evaluation of non intentional effects on the wine making process and wine's qualitative parameters of Botector applied against Botrytis cinerea (Pers.) on grapevine (white berry variety) in Trentino Alto-Adige region (North-eastern Italy). SAGEA Centro di Saggio s.r.i. Study Code: Protocol-172-Grape-2009 (247.V.SAG09/e).

Evaluate unintentional effects on the quality of wine after fungicide applications. Promo-Vert / Staphyt Processing. Reference: FVIBF02/ CEB-10-6405.

29 March 2016

2006

2002

2007

23 February, 2016

30 December 2009.

November 2011

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Proceedings of the 1st International Symposium on Biological Control of Bacterial Plant Diseases,W. Zeller, Vol. 408 (p.249-253). Arno Brynda, BerlinNew York Fruit Quaterly 10:3-6.Journal of Applied Microbiology

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128525

128529

128524

128522

128521

128520

Appx 5.7_WeiBhaupe


Appx 5.3_IIM_4_6_M

Appx 5.2_IIIM_4_8_M

Appx 6.3_SDS_14941

Appx 6.2_label

WeiBhaupe, S

Anonymous



Anonymous

Anonymous

Final Report Sensory Evaluation of Grapes after Treatment with Botector. Bio-Protect GMBH, Germany.

Proposed Botector Fungicide label

Tier 2 Summary of the Metabolism and Residues Studies on the Microbial Pest Control Agent Aureobasidium pullulans Strain DSM 14941) Annex IIM Section 4, Point 6 Document M bio-ferm Biotechnologische Entwicklung und Produktion GmbH

Tier 2 Summary of the Residues in/on Food and Feed products for the Microbial Pest Control Product (Rationale to waive residue studies on MPCP)(Blossom Protect) Annex IIIM Section 4, Point 8 Document M bio-ferm Biotechnologische Entwicklung und Produktion GmbH bio-ferm Biotechnologische Entwicklung und Produktion GmbH, Austria

SAFETY DATA SHEET according to VO 1907/2006/EG, adapted by VO 453/2010/EG Aureobasidium pullulans DSM 14941. 17.04.2015

Proposed Botector Fungicide label

2 June 2010

30 March 2016

4 August 2015

30 July 2015

17 April 2015

30 March 2016

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128519

128523

128518

128530

128703

128713

128712

Appx 6.6_letter

Appx 5.4_IIM_4_6_M

Appx 6.5_SDS botector

Appx 5.5_34/2013

Appx 8.2_BOTRYTIS-2015

Appx 8.12_NUQLD-15-F01

Appx 8.11_NUWAH-15-F21

Donat, C.


Anonymous

Anonymous

R & D Solutions

S.Tancred

S.Paton

Cover letter for confidential information provided to the APVMA from bio-ferm dated 23.02.16. Document J confidential information was provided under cover of this letter.

Tier 2 Summary of the Metabolism and Residues Studies on the Microbial Pest Control Agent Aureobasidium pullulans(Strain DSM 14940) Annex IIM Section 4, Point 6 Document M bio-ferm Biotechnologische Entwicklung und Produktion GmbH, Austria

Safety Data Sheet according to VO 1907/2006/EG, adapted by VO 453/2010/EG Botector 29.03.2016

COMMISSION REGULATION (EU) No 34/2013 of 16 January 2013 (Annex IV to Regulation (EC) No 396/2005). Official Journal of the European Union

Evaluation of NUL 3135 for the control of Botrytis bunch rot in wine grapes cv. Sauvignon Blanc

Comparison of NUL 3135 +/- Teldor 500 SC with Teldor alone, Switch 625 WG and Corvette Flowable 500 SC for the control of Botrytis bunch rot (Botrytis cinerea) in wine grapes cv. Sauvignon Blanc

Candidate screen for botrytis control in grapevines

23 February 2016

3 August 2015

29 March 2016

16 January 2013

April 2015

19 May 2016

20 April 2016

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128711

128710

128702

128709

128707

128706

128705

128704

128708



Appx 8.1_NUSA-14-F212

Appx 8.8_NULAV-16-F01

Appx 8.6_BOTRYTIS-2016

Appx 8.5_NUSA-15-F212



Appx 8.7_NULAV-16-F02

S.Paton

S.Paton

L. Bartlett and B. Hall

D.Hughes

R & D Solutions

L. Bartlett & B. Hall

S.Paton

S. Paton

D. Hughes



Evaluation of NUL 3135 for the control of Botrytis bunch rot on wine grapes cv. Pinot Noir, Lenswood, South Australia 2014-2015

Evaluation of candidate fungicide for the control of Botrytis bunch rot in grapes

Evaluation of NUL 3135 for the control of Botrytis bunch rot on wine grapes cv. Sauvignon blanc

Evaluation of NUL 3135 for the control of Botrytis bunch rot on wine grapes cv. Chardonnay, Loxton, South Australia 2015-2016



Evaluation of candidate fungicide for the control of Botrytis bunch rot in wine grapes

June 2016

June 2016

April 2015

May 2016

May 2016

June 2016

20 April 2015

20 April 2015

May 2016

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120535

128517

120615

120600

120599

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Appx 2.54_SDS14941

Appx 6.4_SDS 14940

Appx 7.33_09/159

Appx 7.38_TTA

Appx 7.36_09/127

Appx 7.35_09/097

Anonymous

Anonymous

Gty, S.

Fritz, J. I.

Gty, S.

Gty, S.

SAFETY DATA SHEET according to VO 1907/2006/EG, adapted by VO 453/2010/EG Aureobasidium pullulans DSM 14941.

SAFETY DATA SHEET according to VO 1907/2006/EG, adapted by VO 453/2010/EG Aureobasidium pullulans DSM 14940 17.04.2015

Avian oral pathogenicity and toxicity study of Aureobasidium pullulans DSM14941 on Japanese quail (Coturnix coturnix japonica). Generated by: LAB Research Ltd., 8200 Veszprm, Szabadsgpuszta, Hungary. Report No: 09/159-115F

Toxicity test with algae. Generated by: University of Natural Resources and Applied Life Sciences, Vienna, Department for Agrobiotechnology Tulln, Institute for Environmental Biotechnology, Tulln Report No: Bioferm_algae.doc Amendment to the report from 2007, January, 24th Toxicity test with algae. (dated 12/03/2009) Generated by: University of Natural Resou

DAPHNIA CONCENTRATION RANGE-FINDING TEST WITH BLOSSOM PROTECT (COMPONENT B) AND WITH TANK SOLUTION Generated by: LAB Research Ltd., Szabadsagpuszta, H-8200 Veszprem. Report No: 09/127-023DA

PRELIMINARY TEST WITH BLOSSOM PROTECT (COMPONENT B) FOR THE DAPHNIA STUDIES Generated by: LAB Research Ltd., Szabadsagpuszta, H-8200 Veszprem. Report No: 09/097-023DAE

17.04.2015

17 April 2015

2009

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120597

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120596

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120591

Appx 7.34_06/282

Appx 7.39_10/271


Appx 7.1_IIM_5_7

Part 7.1_Botector

Appx 7.9_AVL72

Appx 7.28_UNR

Herndi, D.

Agh, I.

Anonymous


Leach, S

Slavikova, E

Fritz, J.

Fish acute toxicity study with Component B of Blossom Protect fb on rainbow trout (Oncorhynchus mykiss). Generated by: LAB International Research Centre Hungary Ltd., Veszprm, Szabadgpuszta, Hungary. Report No: 06/282-009H

Growth Inhibition Test with Blossom Protect on Lemna gibba Generated by: LAB Research Ltd., Szabadsagpuszta, H-8200 Veszprem. Report No: 10/271-029BL

Botector Fungicide proposed label

Tier 2 Summary of Fate and Behaviour in the Environment of the Microbial Pest Control Agent Aureobasidium pullulans (Strain DSM 14941). Annex IIM Section 5, Point 7 Document M August 2015. bio-ferm Biotechnologische Entwicklung und Produktion GmbH

BOTECTOR FUNGICIDE DECISION ID: DC27-15101099 PAA ID Number:PAA-1445817890768 Item 27 submission Part 7.1 - Environmental fate

Seasonal occurrence of yeasts and yeast-like organisms in the river Danube.

Expression in a terrestrial Environment. Generated by: University for Natural Resources and Applied Life Sciences, Department IFA-Tulln, Konrad Lorenz Str. 20. A-3430 Tulln

2007

2011

30 March 2016

August 2015

March 2016

1997

2006

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Antonie van Leeuwenhoek 72:77-80.-

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120595

128516

120602

120604

120614

120613

Appx 7.30_UK

Appx 6.1_DAR

Appx 7.40_09/127

Appx 7.42_BPB

Part 7.2_Botector

Appx 7.51_PMRA

Vogele, R.

Anonymous

Gty, S.

Donat, C.

Leach, S

Anonymous

Expression in an Aquatic Environment. Generated by: University Konstanz, Lehrstuhl fr Phytopathologie. Universittsstrae 10.78467 Konstanz,

Final addendum to the Draft Assessment Report (DAR) for Aureobasidium Pullulans. 2013

ORAL TOXICITY TEST WITH BLOSSOM PROTECT (COMPONENT B) AND WITH TANK SOLUTION ON HONEY BEES (Apis mellifera). Generated by: LAB Research Ltd., Szabadsagpuszta, H-8200 Veszprem. Report No: 09/127-116MT

Statement on toxicity of the active substance of Blossom Protect on bees.. Generated by: bio-ferm, Biotechnologische Entwicklung und Produktion GmbH, Konrad Lorenz Strasse 20, 3430 Tulln, Austria

BOTECTOR FUNGICIDE DECISION ID: DC27-15101099 PAA ID Number:PAA-1445817890768 Item 27 submission Part 7.2 - Environmental toxicology

Proposed Registration Decision Aureobasidium pullulans strain DSM 14940 and Aureobasidium pullulans strain DSM 14941. PMRA Document Number: 2177980. Health Canadas Pest Management Regulatory Agency (PMRA).

2009

March 2013

2009

2007

March 2016

2009

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120612

120611

120603

120610

120608

Appx 7.50_FIFRA

Appx 7.49_PPP

Appx 7.41_AM

Appx 7.48_TTP

Appx 7.46_EW

Borges, S.

Berg, G.

Moosbeckhofer R.et al.,

Fritz, J. I.

Fritz, J. I.

Environmental risk assessment for the FIFRA Section 3 registration of Aureobasidium pullulans strain DSM 14940 and strain DSM 14941 for control of diseases in pome fruits, stone fruits, grapes, and strawberries. (PC Code 036010;EPA File Symbols 86174-R, -E, -G, -U). United States Environmental Protection Agency. Washington, DC.

Potential Plant Pathogenicity of Aureobasidium pullulans Generated by: Graz University of Technology, Petersgasse 12, 8010 Graz.

Use of honeybees (Apis mellifera) as vectors for fire blight antagonists in field experiments. Generated by: AGES Austrian Agency for Health and Food Safety Ltd. (AGES), Spargelfeldstrae 191, A-1226 Vienna.

Toxicity test with plants. Generated by: University of Natural Resources and Applied Life Sciences, Vienna, Department for Agrobiotechnology Tulln, Institute for Environmental Biotechnology, Tulln Report No: Bioferm_plants.doc

Acute toxicity test with earthworms. Generated by: University of Natural Resources and Applied Life Sciences, Vienna, Depart for Agrobiotech Tulln, Institute for Environmental Biotechnology, Tulln Report No: Bioferm_dendrobena_acute.doc. Amend to report from 2007, Jan, 31th Toxicity test with earthworms. (dated 12/03/2009) Generated by: University of Natural Resources and Applied Life Sciences

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Appx 7.47_EW

Appendix 7.44

Appx 7.43_BB

Appx 7.45_06/262

Appx 2.52_EU34/2013

Fritz, J. I.

Wallner, K.

Wallner, K.

Herndi, D.

Anonymous

Avoidance test with earthworms. Generated by: University of Natural Resources and Applied Life Sciences, Vienna, Dept for Agrobiotech Tulln, Institute for Environmental Biotechnology, Tulln Report No: bioferm_dendrobena_avoidance.doc. Amendment to report from 2007, Jan, 31th Avoidance test with earthworms. (12/03/2009) Generated by:: University of Natural Resources andApplied Life Sciences

Bekmpfung des Feuerbranderregers im Obstbau ohne Antibiotika- Hefeprperate gegen den Feuerbrand und ihr Einfluss auf den Sporengehalt von Kernobsthonig. Generated by: Universitt Hohenheim/ Landesanstalt fr Bienenkunde, August von Hartmann Str. 13, D-70593 Stuttgart

Bekmpfung des Feuerbranderregers im Obstbau ohne Antibiotika- Hefeprperate gegen den Feuerbrand und ihr Einfluss auf den Sporengehalt von Kernobsthonig. Generated by: Universitt Hohenheim/ Landesanstalt fr Bienenkunde, August von Hartmann Str. 13, D-70593 Stuttgart

Effect of Component B of Blossom Protect fb on the Predatory Mite Typhlodromus pyri in a Laboratory Trial. Generated by: LAB International Research Centre Hungary Ltd., Veszprm, Szabadgpuszta, Hungary Report No: 06/262-335RACOMMISSION REGULATION (EU) No 34/2013 of 16 January 2013

2007

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2007

16 January 2013

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Official Journal of the European Union

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120533

120532

118892

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118884

Appx 2.51_JAM

Appx 2.24_AMB62

Appx 3.35_139: 45-52

Appx 3.34_51: 209-213

Appx 3.33_20: 191-195

Appx 3.32_2: 87-95Appx 3.36_

Appx 3.31_12: 1544-1545

Appx 3.29_15:353-355Appx 3.28_20:229-230

Appx 3.27_12:101-106

Loncaric I.

Leathers T.D.

Taylor P.E., et al.

Hawkes M., Rennie R., Sand C., Vaudry W.

Koppang H.S., Olsen I., Stuge U., Sandven P.

Matsumoto T.

Kunz, S

Ibanez Perez R., Chacon J., Fidalgo A., Martin J., Paraiso V.

Clark E.C., Silver S.M., Hollick G.E., Rinaldi M.G.Arranz Sanchez D.M., et al.

Vishnoi S., Naidu J., Singh S.M., Vishnoi R.

Strain-specific detection of two Aureobasidium pullulans strains, fungal biocontrol agents of fire blight by using multiplex PCR.

Biotechnological production and applications of pullulan.

Identification and Possible Disease Mechanisms of an Under-Recognized Fungus, Aureobasidium pullulans.Aureobasidium pullulans infection: Fungemia in an infant and a review of human cases.

Aureobasidium infection of the jaw.

Medical significance of the so called black yeasts.Study on the mode of action of Aureobasidium pullulans (DSM14940 and DSM 14941) against the fire blight pathogen Erwinia amylovora.

Peritonitis by Aureobasidium pullulans in continuous ambulatory peritoneal dialysis.

Continuous Ambulatory Peritoneal Dialysis Complicated by Aureobasidium pullulans Peritonitis.Subcutaneous mycosis produced by Aureobasidium pullulans in a renal transplant recipient.

Clinical and Experimental Infection due to Aureobasidium pullulans: Study of Pathogenicity of a Clinical Isolate for Albino Rats.

2007

2003

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Journal of Applied Microbiology Submitted for publication

Applied Microbiology and Biotechnology 62:468-473.

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119913

119912

119911

Appx 3.26_44:1215-1218

Appx 3.30_16-1: 97-98Appx 3.25_133:663-664

Project Plan v1

B&BP formulations

Appx 3.9_ARC-UL-0608

Appx 3.8_KBL/2006/1540Rsc


Tan H. P.

Caporale N.E., Calegari L., Perez D., Gezuele E.Redondo-Bellon P.

D.Rumbold

C.Donat

Wolf, T

Muller, W.

Muller, W.

Aureobasidium pneumonia a post liver transplant recipient: a case report.

Peritoneal Catheter Colonization and Peritonitis with Aureoabsidium pullulans.

Chromoblastomycosis produced by Aureobasidium pullulans in an immunosppressed patient.

Item 27 Timeshift Application Project Plan

Confidential formulation information for Botector and Blossom Protect - cover letter. Data to follow in 7 days

â??BP2042â??: Acute oral Toxicity Study with Rats (Acute Toxic Class Method). Unpublished Report No: ARC-UL-0608.

Determination of the Toxic/Infectious/ Pathogen Behaviour of Aureobasidium pullulans (DSMZ 14941) in the Rat after Subcutaneous Administration. Unpublished Report No: KBL/2006/1540Rsc

Determination of the Toxic/Infectious/ Pathogen Behaviour of two Strains of Aureobasidium pullulans (DSMZ 14940 and 14941) in the Rat after Subcutaneous Administration. Unpublished Report No: KBL/2004/1474Rsc

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4 February 2016

23 February 2016

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Technologiezentrum Tulln, Technopark 1, 3430 Tulln, Austria103-105 PIPE RD, LAVERTON NORTH, VIC 3026 AUSTRALIA







119910

119902

119909

119907

119906

119905

Appx 3.6_E-400/2006

Draft label v1

Appx 3.5_E-318/2006

Appx 3.2_Tier 2 MPCA0


Part 3_Tox

Zeljenkova D

Leach, S.

Zeljenkova D



Leach, S.

Acute Pulmonary Toxicity / Pathogenicity in rats according to EPA Microbial Pesticide Test Guidelines OPPTS 885.3150. Unpublished Report No: E-400/2006

Draft label for Botector Fungicide

Acute Oral Toxicity / Pathogenicity in rats according to EPA Microbial Pesticide Test Guidelines OPPTS 885.3050. Unpublished Report number E-318/2006

Tier 2 Summary of the Toxicological Studies and Exposure Data and Information on the Microbial Pest Control Agent Aureobasidium pullulans (Strain DSM 14940). Annex IIM Section 3, Point 5 Document M August 2015 bio-ferm Biotechnologische Entwicklung und Produktion GmbH


Part 3 - Toxicology

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February 2016

2006

August 2015

August 2015

February 2016

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119904

119908

119914

118881

118879

118864

118863

Appx 3.4_EFSA

Appx 3.3_Tier 2 MPCP


Appx 3.24_23 :828-831Appx 3.22_41:4483-4485


Appx 3.6_E-400/2006

EFSA


Bernat, E

Salkin I. F.

Bolignano G.

Muller, W.

Zeljenkova D

Conclusion on the peer review of the pesticide risk assessment of the active substance Aureobasidium pullulans (strains DSM 14940 and DSM 14941) EFSA Journal 2013;11(4):3183

Tier 2 Summary of the Toxicological Studies and Exposure Data and Information on the Microbial Pest Control Product, Blossom Protect. Annex IIM Section 3, Point 7 Document M July 2015 bio-ferm Biotechnologische Entwicklung und Produktion GmbH

â??BP2042â??: Acute dermal Toxicity Study with Rats. Unpublished Report No: ARC-UL-0614

Opportunistic infection of the spleen caused by Aureobasidium pullulans.Disseminated Nosocomial Fungal Infection by Aureobasidium pullulans var. melanigenum: a Case Report. J. Clin. Microbiol. 41:4483-4485.

Determination of the Toxic/Infectious/ Pathogen Behaviour of two Strains of Aureobasidium pullulans (DSMZ 14940 and 14941) in the Rat after Subcutaneous Administration. Unpublished Report No: KBL/2004/1474Rsc

Acute Pulmonary Toxicity / Pathogenicity in rats according to EPA Microbial Pesticide Test Guidelines OPPTS 885.3150. Unpublished Report No: E-400/2006

2013

July 2015

2003

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118862

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118865

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118857

Appx 3.5_E-318/2006

Appx 3.3_Tier 2 MPCP



Part 3_Tox

Appx 3.4_EFSA

Zeljenkova D


Muller, W.


Leach, S.

EFSA

Acute Oral Toxicity / Pathogenicity in rats according to EPA Microbial Pesticide Test Guidelines OPPTS 885.3050. Unpublished Report number E-318/2006

Tier 2 Summary of the Toxicological Studies and Exposure Data and Information on the Microbial Pest Control Product, Blossom Protect. Annex IIM Section 3, Point 7 Document M July 2015 bio-ferm Biotechnologische Entwicklung und Produktion GmbH

Determination of the Toxic/Infectious/ Pathogen Behaviour of Aureobasidium pullulans (DSMZ 14941) in the Rat after Subcutaneous Administration. Unpublished Report No: KBL/2006/1540Rsc


Part 3 - Toxicology

Conclusion on the peer review of the pesticide risk assessment of the active substance Aureobasidium pullulans (strains DSM 14940 and DSM 14941) EFSA Journal 2013;11(4):3183

2006

July 2015

2006

August 2015

February 2016

2013

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118856

118855

118859

118880

118866

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118878

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118876

B&BP formulations

Draft label v1


Appx 3.23_13:289-291



Appx 3.21_41:149-61Appx 3.20_39:407-417

Appx 3.19_2004

C.Donat

Leach, S.


Kaczmarski E. B.

Wolf, T

Weniger, P

Buzina, W

deHoog G. S

Kunz, S

Confidential formulation information for Botector and Blossom Protect - cover letter. Data to follow in 7 days

Draft label for Botector Fungicide


Systemic infection with Aureobasidium pullulans in a leukemic patient.

â??BP2042â??: Acute oral Toxicity Study with Rats (Acute Toxic Class Method). Unpublished Report No: ARC-UL-0608.

â??BP2042â??: Acute inhalation Toxicity in Rats. Unpublished Report No: ARC-UL-0638

Fungal biodiversity as found in nasal mucus. Med Mycol 41:149-61.Risk assessment of fungi reported from humans and animals.

Influence of temperature on the reproduction of different A. pullulans strains. Unpublished Report.

23 February 2016

February 2016

August 2015

1986

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bio-ferm GmbH

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Technologiezentrum Tulln, Technopark 1, 3430 Tulln, Austria103-105 PIPE RD, LAVERTON NORTH, VIC 3026 AUSTRALIA


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118875

118867

118874

118872

118871

118870

118869

118873

Appx 3.18_JAM-2007-0425


Appx 3.17_319/06






Loncaric, I

Bernat, E

Zeljenkova, D

Wolf, T

Weiss-Fuchs, U

Wolf, T

Wolf, T

Hruby R

Strain-specific detection of two Aureobasidium pullulans strains, fungal biocontrol agents of fire blight by new developed multiplex PCR. Applied Microbiology JAM-2007-0425

â??BP2042â??: Acute dermal Toxicity Study with Rats. Unpublished Report No: ARC-UL-0614

Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test. Unpublished Report No: 319/06

â??BP2042â??: Acute Subcutaneous Toxicity Study with Rats. Unpublished Report No: ARC-UL-0609

â??BP2042â??: Skin Sensitisation Study (Buehler Test). Unpublished Report No: ARC-UL-0601

â??BP2042â??: Acute Eye Irritation/Corrosion Study with Rabbits. Unpublished Report No: ARC-UL-0611

â??BP2042â??: Acute Dermal Irritation/Corrosion Study with Rabbits. Unpublished Report No: ARC-UL-0610

More Detailed Discussion of the Report: â??BP2042â??: Acute Subcutaneous Toxicity Study with Rats, ARC--UL-0609, .

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2003

2003

January 2003

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128714

119915

119917

120517

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120515

120514

120518

Appx 8.14_09FVIBF01



Appx 2.4_CBVS

Appx 2.3_CBVS

Appx 2.2_ IIM_1_1_M

Appx 2.1_IIM_1_1_M

Appx 2.5_SM61

R. Fraga

Weniger, P

Wolf, T

Yurlova N.

Sterflinger K

Strutzenberger K, Donat C


Zalar P.

Fungicide efficacy and selectivity of the formulations Botector and Yeast A on Botrytis cinerea on grapevines in Spain in 2009

â??BP2042â??: Acute inhalation Toxicity in Rats. Unpublished Report No: ARC-UL-0638

â??BP2042â??: Acute Eye Irritation/Corrosion Study with Rabbits. Unpublished Report No: ARC-UL-0611

Taxonomy of Aureobasidium and allied genera. Ecology and Evolution of black yeasts and their relatives.

Phylogeny and Ecology of meristematic ascomycetes. Ecology and Evolution of black yeasts and their relatives. Tier 2 Summary of the Identity of the Microbial Pest Control Agent Aureobasidium pullulans (Strain DSM 14940). Annex IIM Section 1, Point 1 Document M bio-ferm Biotechnologische Entwicklung und Produktion GmbH

Tier 2 Summary of the Identity of the Microbial Pest Control Agent Aureobasidium pullulans (Strain DSM 14941). Annex IIM Section 1, Point 1 Document M bio-ferm Biotechnologische Entwicklung und Produktion GmbH

Redefinition of Aureobasidium pullulans and its varieties.

2009

2003

2003

1999

1999

27 July 2015

3 August 2015

2008

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Central bureau voor Schimmelcultures.

Central bureau voor Schimmelcultures

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Studies in Mycology 61: 2138.

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120513

120511

120510

120509

120508

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120507

Appx 2.10_AT-2758

Appx 2.8_TPR

Appx 2.25_BF

Appx 2.29_FDA18

Appx 2.13_IIM_2_4_M

Appx 2.9_TPR2

Appx 2.12_IIM_2_4_M

Knittl,P

Pichler, E

Donat C.

Tournas V, Stack ME, Mislivec PB, Koch HA and Bandler, R


Daxner, B


Test Report AT-2758-1-8 - Analysis of fungal metabolites in culture materials of Aureobasidium pullulans. Generated by: Quantas Analytics, Romer Labs Diagnostics Europe GmbH. A-3430 Tulln, Technopark 1.


Determination of colony forming units (CFU) of Aureobasidium pullulans DSM14941 and 14940 Generated by: bio-ferm GmbH, Technopark 1, 3430 Tulln, Austria

FDA Bacteriological Analytical Manual. Chapter 18 Yeasts, molds and mycotoxins US Food and Drug Administration. April 2001.

Tier 2 Summary of the Analytical Methods for the Microbial Pest Control Agent Aureobasidium pullulans (Strain DSM 14940). Annex IIM Section 2, Point 4 Document M bio-ferm Biotechnologische Entwicklung und Produktion GmbH


Tier 2 Summary of the Analytical Methods for the Microbial Pest Control Agent Aureobasidium pullulans (Strain DSM 14941). Annex IIM Section 2, Point 4 Document M bio-ferm Biotechnologische Entwicklung und Produktion GmbH

2014

2011

2015

April 2001.

3 August 2015

2011

4 August 2015

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http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071435.htm

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120519

120521

120531

120530

120529

120528

120520

120527

120525

120524

Appx 2.6_IIM_1_2_M

Appx 2.23_FCT35

Appx 2.22_JSCS66

Appx 2.21_CJM48

Appx 2.20_ZFPP101

Appx 2.19_MM41Appx 2.7_MOA

Appix 2.18_JIMB30

Appx 2.16_AVL72

Appx 2.15_Al40


Kimoto T.

Jakovljevic D.

Andrews J. H.

Falconi C. J.

Buzina W.

Kunz, S

Punnapayak H.

Slavikova, E.

Kaypla, M.

Tier 2 Summary of the Biological properties of the Microbial Pest Control Agent Aureobasidium pullulans (Strain DSM 14941). Annex IIM Section 1, Point 2 Document M bio-ferm Biotechnologische Entwicklung und Produktion GmbH

Safety studies of a novel starch, pullulan: Chronic toxicity in rats and bacterial mutagenicity.Fine structural analysis of the fungal polysaccharide pullulan elaborated by Aureobasidium pullulans, CH-1 strain.

Population biology of Aureobasidium pullulans on apple leaf surfaces.

Epiphytic fungi on apple leaves and their value for control of the postharvest pathogen Botrytis cinerea, Monilia fructigena and Penicillium expansum.

Fungal biodiversity as found in nasal mucus.Study on the mode of action of Aureobasidium pullulans (DSM14940 and DSM 14941) against the fire blight pathogen Erwinia amylovora. Generated by : Bio-protect, Lohnehoferstr. 7, D-78467 Konstanz

Characterization of Aureobasidium pullulans isolated from airborne spores in Thailand.

Seasonal occurrence of yeasts and yeast-like organisms in the river Danube.

Frame fungi on insulated windows.

3 August 2015

1977

2000

2002

1994

2003

2007

2003

1997

1985

-

Food and Chemical Toxicology 35:323-329.Journal of the Serbian Chemical Society 66:377-383.

Canadian Journal for Microbiology 48:500-513.

Zeitschrift fr Pflanzenkrankheiten und Pflanzenschutz. 101:38-47

Med Mycol 41:149-61.-

Journal of Indian Microbiology and Biotechnology 30:89-94.

Antonie van Leeuwenhoek 72:77-80.

Allergy 40:558-64.

Applicant

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120523

120522

120526

119916

120506

120504

119927

119926

119925

119924

Appx 2.14_EFSA

Appx 2.11_letter

Appx 2.17_AEM35


Appx 2.28_FDA5

Appx 2.26_FDA3

Appx 3.23_13:289-291

Appx 3.22_41:4483-4485

Appx 3.21_41:149-61Appx 3.20_39:407-417

Anonymous

Donat, C

Webb T. A

Wolf, T

Andrews WH, Jacobson A, , and Hammack T

Maturin L and Peeler JT

Kaczmarski E. B.

Bolignano G.

Buzina, W

deHoog G. S

Conclusion on the peer review of the pesticide risk assessment of the active substance Aureobasidium pullulans (strains DSM 14940 and DSM 14941).

Cover letter for confidential information provided to the APVMA from bio-ferm dated 23.02.16. Document J confidential information was provided under cover of this letter

Molds on vegetables at the time of harvest.

â??BP2042â??: Acute Dermal Irritation/Corrosion Study with Rabbits. Unpublished Report No: ARC-UL-0610

FDA Bacteriological Analytical Manual. Chapter 5 - Salmonella US Food and Drug Administration. May 2014.

FDA Bacteriological Analytical Manual. Chapter 3 - Aerobic Plate Count US Food and Drug Administration. January 2001.

Systemic infection with Aureobasidium pullulans in a leukemic patient.

Disseminated Nosocomial Fungal Infection by Aureobasidium pullulans var. melanigenum: a Case Report. J. Clin. Microbiol. 41:4483-4485.

Fungal biodiversity as found in nasal mucus. Med Mycol 41:149-61.Risk assessment of fungi reported from humans and animals.

2013

23 February, 2016

1978

2003

May 2014

January 2001.

1986

2003

2003

1996

EFSA Journal 2013;11(4):3183

-

Appl. Environ. Microbiol. 35:655-658.

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119928

119923

119921

119920

119919

119918

119922

120505

119929

Appx 3.24_23 :828-831Appx 3.19_2004

Appx 3.17_319/06




Appx 3.18_JAM-2007-0425

Appx 2.27_FDA4

Appx 3.25_133:663-664

Salkin I. F.

Kunz, S

Zeljenkova, D

Hruby R

Wolf, T

Weiss-Fuchs, U

Loncaric, I

Feng P, Weagant SD, Grant MA, Burkhardt, W

Redondo-Bellon P.

Opportunistic infection of the spleen caused by Aureobasidium pullulans.Influence of temperature on the reproduction of different A. pullulans strains. Unpublished Report.

Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test. Unpublished Report No: 319/06

More Detailed Discussion of the Report: â??BP2042â??: Acute Subcutaneous Toxicity Study with Rats, ARC--UL-0609, .

â??BP2042â??: Acute Subcutaneous Toxicity Study with Rats. Unpublished Report No: ARC-UL-0609

â??BP2042â??: Skin Sensitisation Study (Buehler Test). Unpublished Report No: ARC-UL-0601

Strain-specific detection of two Aureobasidium pullulans strains, fungal biocontrol agents of fire blight by new developed multiplex PCR. Applied Microbiology JAM-2007-0425

FDA Bacteriological Analytical Manual. Chapter 4 - Enumeration of Escherichia coli and the Coliform Bacteria US Food and Drug Administration. Revision February 2013.

Chromoblastomycosis produced by Aureobasidium pullulans in an immunosppressed patient.

1986

2004

2006

January 2003

2003

2003

2007

February 2013.

1997

-

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119931

120503

119940

119939

119938

119930

119937

119935

119934

119933

Appx 3.27_12:101-106

Appx 2.25_CFU

Appx 3.36_

Appx 3.35_139: 45-52

Appx 3.34_51: 209-213

Appx 3.26_44:1215-1218Appx 3.33_20: 191-195

Appx 3.31_12: 1544-1545

Appx 3.30_16-1: 97-98

Appx 3.29_15:353-355

Vishnoi S., Naidu J., Singh S.M., Vishnoi R.

Donat C.

Kunz, S

Taylor P.E., et al.

Hawkes M., Rennie R., Sand C., Vaudry W.

Tan H. P.

Koppang H.S., Olsen I., Stuge U., Sandven P.

Ibanez Perez R., Chacon J., Fidalgo A., Martin J., Paraiso V.

Caporale N.E., Calegari L., Perez D., Gezuele E.

Clark E.C., Silver S.M., Hollick G.E., Rinaldi M.G.

Clinical and Experimental Infection due to Aureobasidium pullulans: Study of Pathogenicity of a Clinical Isolate for Albino Rats.

Determination of colony forming units (CFU) of Aureobasidium pullulans DSM14941 and 14940 Generated by: bio-ferm GmbH, Technopark 1, 3430 Tulln, Austria

Study on the mode of action of Aureobasidium pullulans (DSM14940 and DSM 14941) against the fire blight pathogen Erwinia amylovora.

Identification and Possible Disease Mechanisms of an Under-Recognized Fungus, Aureobasidium pullulans.

Aureobasidium pullulans infection: Fungemia in an infant and a review of human cases.

Aureobasidium pneumonia a post liver transplant recipient: a case report.

Aureobasidium infection of the jaw.

Peritonitis by Aureobasidium pullulans in continuous ambulatory peritoneal dialysis.

Peritoneal Catheter Colonization and Peritonitis with Aureoabsidium pullulans.

Continuous Ambulatory Peritoneal Dialysis Complicated by Aureobasidium pullulans Peritonitis.

2002

2015

2007

2006

2005

1997

1991

1997

1996

1995

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119932

119936

128715

Appx 3.28_20:229-230

Appx 3.32_2: 87-95Appx 8.15_PO09013 P01

Arranz Sanchez D.M., et al.

Matsumoto T.

S.Rodrigues

Subcutaneous mycosis produced by Aureobasidium pullulans in a renal transplant recipient.

Medical significance of the so called black yeasts.Efficacy of Botector and Yeast A against Botrytis cinerea in vineyards

2006

1987

02 Dec 2009

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Public

Public

Applicant

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