apvma gazette no. 09, 05 may 2020 · applicant name: turf culture pty ltd applicant acn: 117 986...
TRANSCRIPT
Gazette
Agricultural and
Veterinary Chemicals
No. APVMA 9, Tuesday, 5 May 2020
Published by the Australian Pesticides and Veterinary Medicines Authority
The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The
Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be
published in the Gazette containing details of the registration of agricultural and veterinary chemical products
and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code
and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet
Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.
ISSN 1837-7629
© Commonwealth of Australia 2020
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any
process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and
inquiries concerning reproduction and rights should be addressed to:
Assistant Director, Communications
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Email: [email protected]
Website: apvma.gov.au
GENERAL INFORMATION
The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of
the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as requi red
by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material
issued by the APVMA.
Pursuant to section 8J(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications
made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in
quarterly statistical reports.
DISTRIBUTION AND SUBSCRIPTION
The APVMA Gazette is published in electronic format only and is available from the APVMA website.
If you would like to subscribe to receive email notification when a new edition is published, please complete the subscription
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APVMA CONTACTS
For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6770 2300.
For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Agricultural Chemical Products and Approved Labels..................................................................................................... 4
Veterinary Chemical Products and Approved Labels .................................................................................................... 11
Approved Active Constituents ....................................................................................................................................... 16
New agricultural active constituent: metcamifen ........................................................................................................... 17
New chemical product: EPIVIO C Sorghum Seed Safener containing metcamifen ...................................................... 19
Change to conditions for the export of phorate ............................................................................................................. 21
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 4
Agricultural Chemical Products and Approved Labels
Agricultural Chemical Products and Approved Labels
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals
Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of
the registration in respect of the following products and has approved the label or varied the relevant particulars or
conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.: 123645
Product name: Choice Methomyl 225 Insecticide
Active constituent/s: 225 g/L methomyl
Applicant name: Grow Choice Pty Ltd
Applicant ACN: 161 264 884
Summary of use: For the control of insect pests in various crops
Date of registration: 14 April 2020
Product registration no.: 89112
Label approval no.: 89112/123645
Application no.: 121354
Product name: Sundew Household Flea Spray With Fragrance
Active constituent/s: 0.125 g/L imidacloprid
Applicant name: Sundew Solutions Pty Ltd
Applicant ACN: 135 400 261
Summary of use: To control fleas on carpets, pet bedding, and surrounding areas
Date of registration: 14 April 2020
Product registration no.: 88446
Label approval no.: 88446/121354
Application no.: 123265
Product name: Superway Grub, Ant And Pest Controller
Active constituent/s: 100 g/L bifenthrin
Applicant name: Pooma Fertilizers Pty Ltd
Applicant ACN: 625 414 164
Summary of use: For the control of a range of pests in turf and ornamental plants. For the control of a wide range of interior and exterior pests. For the control of ants, lawn grub/army worm, African black beetle by forming residual surface treatments on a range of urban Interior and exterior situations
Date of registration: 16 April 2020
Product registration no.: 89025
Label approval no.: 89025/123265
Application no.: 118825
Product name: Imtrade Iconix 500 EC Herbicide
Active constituent/s: 500 g/L ioxynil present as the octanoate
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of use: For the control of certain broadleaf weeds in onion crops
Date of registration: 17 April 2020
Product registration no.: 87625
Label approval no.: 87625/118825
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 5
Agricultural Chemical Products and Approved Labels
Application no.: 122668
Product name: Jarrah Fungicide
Active constituent/s: 250 g/L triadimenol
Applicant name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of use: For control of fungal diseases in a variety of crops and turf
Date of registration: 17 April 2020
Product registration no.: 88848
Label approval no.: 88848/122668
Application no.: 121408
Product name: AC Carfentrazone 400 Herbicide
Active constituent/s: 400 g/L carfentrazone-ethyl
Applicant name: Axichem Pty Ltd
Applicant ACN: 131 628 594
Summary of use: For improvement in the control of marshmallow and certain other broadleaf weeds prior to establishment of broadacre crops, fallows or forest plantations, in commercial, industrial and public service areas, around agricultural buildings and yards, in tree fruits, nuts, grape vines in tank mixture with knockdown herbicides; control of marshmallow and annual nettles in grass pastures and rough grass/turf areas; and control of volunteer cotton seedlings including Roundup Ready cotton and desiccation of cotton re-growth
Date of registration: 17 April 2020
Product registration no.: 88478
Label approval no.: 88478/121408
Application no.: 123757
Product name: Relyon Triple Herbicide
Active constituent/s: 250 g/L MCPA present as the ethyl hexyl ester, 250 g/L bromoxynil present as the octanoate, and 25 g/L diflufenican
Applicant name: Ruralco Holdings Limited
Applicant ACN: 009 660 879
Summary of use: For the control of certain broadleaf weeds in wheat, barley, triticale and cereal rye
Date of registration: 20 April 2020
Product registration no.: 89151
Label approval no.: 89151/123757
Application no.: 123755
Product name: Multicrop Take Root Plant Rooting Liquid
Active constituent/s: 4 g/L indole butyric acid
Applicant name: Multicrop (Aust) Pty Ltd
Applicant ACN: 001 102 889
Summary of use: For striking and accelerating roots on most plant cuttings
Date of registration: 20 April 2020
Product registration no.: 89150
Label approval no.: 89150/123755
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 6
Agricultural Chemical Products and Approved Labels
Application no.: 121211
Product name: Imtrade Spire 500 EC Fungicide
Active constituent/s: 500g/L spiroxamine
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of use: For the control of powdery mildew in grapevines
Date of registration: 22 April 2020
Product registration no.: 88400
Label approval no.: 88400/121211
Application no.: 121556
Product name: 4Farmers Fipronil 500 Insecticidal Seed Treatment
Active constituent/s: 500 g/L Fipronil
Applicant name: 4 Farmers Australia Pty Ltd
Applicant ACN: 160 092 428
Summary of use: For the control of various pests in canola, rice, sorghum, and sunflowers and to protect seedlings from attack from black field earwig in sorghum and sunflowers
Date of registration: 22 April 2020
Product registration no.: 88511
Label approval no.: 88511/121556
Application no.: 123796
Product name: Apparent TebuPro 420SC Fungicide
Active constituent/s: 210 g/L prothioconazole, 210 g/L tebuconazole
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of use: For the control of various diseases in wheat, barley, oats, triticale, canola and pyrethrum
Date of registration: 23 April 2020
Product registration no.: 89161
Label approval no.: 89161/123796
Application no.: 120815
Product name: Clearout Plus IGR Crawling Insect Spray
Active constituent/s: 0.5 g/kg fipronil and 0.15 g/kg pyriproxyfen
Applicant name: Sherwood Chemicals Australasia Pty Ltd
Applicant ACN: 136 993 630
Summary of use: For the control of ants and cockroaches in domestic, commercial, and public buildings
Date of registration: 23 April 2020
Product registration no.: 88298
Label approval no.: 88298/120815
Application no.: 123647
Product name: Sinon Dicast Insecticide
Active constituent/s: 27.5 g/L deltamethrin
Applicant name: Sinon Australia Pty Limited
Applicant ACN: 102 741 024
Summary of use: For the control of heliothis and other specified pests on cotton and other crops
Date of registration: 24 April 2020
Product registration no.: 89113
Label approval no.: 89113/123647
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 7
Agricultural Chemical Products and Approved Labels
Application no.: 120770
Product name: Quali-Pro Negate Herbicide
Active constituent/s: 200 g/kg metsulfuron-methyl, 167 g/kg rimsulfuron
Applicant name: ADAMA Australia Pty Limited
Applicant ACN: 050 328 973
Summary of use: For the control of winter grass, ryegrass, onion weed, and certain broadleaf weeds in couch and couch hybrids, zoysia, and Queensland Blue Couch
Date of registration: 27 April 2020
Product registration no.: 88290
Label approval no.: 88290/120770
2. VARIATIONS OF REGISTRATION
Application no.: 124855
Product name: Yates Grub Kill & Protect For Lawns Up To 6 Months Protection Against Curl Grub
Active constituent/s: 2 g/kg chlorantraniliprole
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Yates Grub Shield kills & protects against lawn grubs for up to 6 months granular’ to ‘Yates Grub Kill & Protect for Lawns up to 6 Months Protection Against Curl Grub’
Date of variation: 9 April 2020
Product registration no.: 88464
Label approval no.: 88464/124855
Application no.: 124905
Product name: Fascinate Dry Herbicide
Active constituent/s: 500 g/kg glufosinate-ammonium
Applicant name: UPL Australia Pty Ltd
Applicant ACN: 066 391 384
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Fascinate 500 SG Herbicide’ to ‘Fascinate Dry Herbicide’
Date of variation: 9 April 2020
Product registration no.: 85197
Label approval no.: 85197/124905
Application no.: 124925
Product name: Artemis Opti Spreader
Active constituent/s: 1020 g/L polyether modified polysiloxane
Applicant name: Liquid Fertiliser Pty Ltd
Applicant ACN: 105 456 148
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Atremis Opti Spreader’ to ‘Artemis Opti Spreader’
Date of variation: 16 April 2020
Product registration no.: 88837
Label approval no.: 88837/124925
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 8
Agricultural Chemical Products and Approved Labels
Application no.: 124963
Product name: Raid Earth Options Botanicals Multi Insect Killer
Active constituent/s: 16.1 g/kg piperonyl butoxide, 3.5 g/kg pyrethrin
Applicant name: S.C. Johnson & Son Pty Ltd
Applicant ACN: 000 021 009
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Raid Botanicals Multi Insect Killer’ to ‘Raid Earth Options Botanicals Multi Insect Killer’
Date of variation: 16 April 2020
Product registration no.: 69287
Label approval no.: 69287/124963
Application no.: 124964
Product name: Raid Earth Options Botanicals Automatic Advanced Multi-Insect Control System
Active constituent/s: 45 g/kg piperonyl butoxide, 9 g/kg pyrethrin
Applicant name: S.C. Johnson & Son Pty Ltd
Applicant ACN: 000 021 009
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Raid Botanicals Automatic Advanced Multi-Insect Control System’ to ‘Raid Earth Options Botanicals Automatic Advanced Multi-Insect Control System’
Date of variation: 16 April 2020
Product registration no.: 69288
Label approval no.: 69288/124964
Application no.: 118078
Product name: Amistar Xtra Fungicide
Active constituent/s: 200 g/L azoxystrobin, 80 g/L cyproconazole
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of variation: To add uses in new cereal crops and extend uses to new diseases in wheat and barley
Date of variation: 17 April 2020
Product registration no.: 57949
Label approval no.: 57949/118078
Application no.: 121557
Product name: Metman 720 WG Systemic and Protective Fungicide
Active constituent/s: 640 g/kg mancozeb, 80 g/kg metalaxyl
Applicant name: Agria S.A.
Applicant ACN: N/A
Summary of variation: To add uses in poppies and to extend the product shelf life
Date of variation: 21 April 2020
Product registration no.: 86145
Label approval no.: 86145/121557
Application no.: 122682
Product name: F.S.A. Propyzamide 500 SC Herbicide
Active constituent/s: 500 g/l propyzamide, 42 g/L mono ethylene glycol
Applicant name: Four Seasons Agribusiness Pty Ltd
Applicant ACN: 115 133 189
Summary of variation: To add uses in canola and to vary the pack size range
Date of variation: 22 April 2020
Product registration no.: 87920
Label approval no.: 87920/122682
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 9
Agricultural Chemical Products and Approved Labels
Application no.: 123800
Product name: Flupron 745 Herbicide
Active constituent/s: 745 g/L flupropanate present as the sodium salt
Applicant name: Ruralco Holdings Limited
Applicant ACN: 009 660 879
Summary of variation: To add use in tea tree for control of giant Parramatta grass
Date of variation: 24 April 2020
Product registration no.: 81889
Label approval no.: 81889/123800
Application no.: 123798
Product name: Overture Fungicide
Active constituent/s: 125 g/L epoxiconazole
Applicant name: Sipcam Pacific Australia Pty Ltd
Applicant ACN: 073 176 888
Summary of variation: To add uses in wheat and barley when tank mixed with 250 g/L azoxystrobin products
Date of variation: 27 April 2020
Product registration no.: 63994
Label approval no.: 63994/123798
3. VARIATION OF LABEL APPROVAL
Application no.: 124037
Product name: Multicrop Multiguard Snail And Slug Killer
Active constituent/s: 60 g/kg iron edta complex
Applicant name: Multicrop (Aust) Pty Ltd
Applicant ACN: 001 102 889
Summary of variation: Removing claim the product is pet friendly
Date of variation: 14 April 2020
Product registration no.: 50312
Label approval no.: 50312/124037
Application no.: 124211
Product name: Aquapro Pro-Knockout For Pools
Active constituent/s: 700 g/kg available chlorine (CI) present as calcium hypochlorite
Applicant name: M I International Pty Ltd
Applicant ACN: 002 869 089
Summary of variation: To approve a new label for the product 'Aquapro Pro-Knockout for Pools' with the label name ‘Clearchem Knockout for Pools'
Date of variation: 22 April 2020
Product registration no.: 62083
Label approval no.: 62083/124211
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 10
Agricultural Chemical Products and Approved Labels
Application no.: 124214
Product name: Aquapro Pure-Chlor For Pools
Active constituent/s: 810 g/kg available chlorine (CI) present as trichloroisocyanuric acid, 100 g/kg sodium tetraborate pentahydrate
Applicant name: M I International Pty Ltd
Applicant ACN: 002 869 089
Summary of variation: To approve a new label for the product 'Aquapro Pure-Chlor For Pools' with the label name 'Clearchem Premium Granular Chlorine For Pools'
Date of variation: 22 April 2020
Product registration no.: 62079
Label approval no.: 62079/124214
Application no.: 124215
Product name: Aquapro Pro-Instant For Pools
Active constituent/s: 720 g/kg available chlorine (CI) present as trichloroisocyanuric acid and sodium dichloroisocyanurate
Applicant name: M I International Pty Ltd
Applicant ACN: 002 869 089
Summary of variation: To approve a new label for the product 'Aquapro Pro-Instant For Pools' with the label name 'Clearchem Insta Shock For Pools'
Date of variation: 22 April 2020
Product registration no.: 62088
Label approval no.: 62088/124215
Application no.: 124216
Product name: Aquapro Dyna-Chlor For Pools
Active constituent/s: 560 g/kg available chlorine present as sodium dichloroisocyanurate
Applicant name: M I International Pty Ltd
Applicant ACN: 002 869 089
Summary of variation: To approve a new label for the product 'Aquapro Dyna-Chlor For Pools' with the label name ‘Clearchem Stabilised Pool Chlorine'
Date of variation: 22 April 2020
Product registration no.: 62090
Label approval no.: 62090/124216
Application no.: 124217
Product name: Aquapro Dyna-Chlor Tabs For Pools
Active constituent/s: 900 g/kg available chlorine present as trichloroisocyanuric acid
Applicant name: M I International Pty Ltd
Applicant ACN: 002 869 089
Summary of variation: To approve a new label for the product ‘Aquapro Dyna-Chlor Tabs’ with the label name Clearchem Stabilised Chlorine Tabs
Date of variation: 22 April 2020
Product registration no.: 62089
Label approval no.: 62089/124217
Application no.: 123831
Product name: Evershield Seed Treatment
Active constituent/s: 360g/L thiram, 200 g/L thiabendazole
Applicant name: Arysta Lifescience Australia Pty Ltd
Applicant ACN: 005 225 507
Summary of variation: To update the safety directions and first aid instructions in line with the FAISD handbook
Date of variation: 27 April 2020
Product registration no.: 65237
Label approval no.: 65237/123831
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 11
Veterinary Chemical Products and Approved Labels
Veterinary Chemical Products and Approved Labels
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals
Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of
the registration in respect of the following products and has approved the label or varied the relevant particulars or
conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS
Application no.: 105030
Product name: Dermcare Barazone 0.25 g/L Budesonide Leave-On Conditioner
Active constituent/s: 0.25 g/L budesonide
Applicant name: Dermcare-Vet Pty Ltd
Applicant ACN: 010 280 010
Summary of use: For the symptomatic treatment of canine atopic dermatitis, contact allergy and other pruritic conditions of the dog
Date of Registration: 15 April 2020
Product registration no.: 82108
Label approval no.: 82108/105030
Application no.: 105036
Product name: Dermcare Barazone 0.125 g/L Budesonide Leave-On Conditioner
Active constituent/s: 0.125 g/L budesonide
Applicant name: Dermcare-Vet Pty Ltd
Applicant ACN: 010 280 010
Summary of use: For the symptomatic treatment of canine atopic dermatitis, contact allergy and other pruritic conditions of the dog
Date of registration: 15 April 2020
Product registration no.: 82113
Label approval no.: 82113/105036
Application no.: 116464
Product name: Arthramid Vet
Active constituent/s: 25 mg/mL cross-linked polyacrylamide hydrogel
Applicant name: IMS Vet Pty Ltd
Applicant ACN: 620 774 094
Summary of use: For the treatment of lameness in horses
Date of registration: 15 April 2020
Product registration no.: 86728
Label approval no.: 86728/116464
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 12
Veterinary Chemical Products and Approved Labels
2. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.: 119891
Product name: Procpen 300 Suspension For Injection
Active constituent/s: 300 mg/mL procaine penicillin
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of use: For the registration of an antibiotic injection product for use in cattle, sheep, pigs, horses, dogs, and cats
Date of registration: 21 April 2020
Product registration no.: 87953
Label approval no.: 87953/119891
Application no.: 119596
Product name: Bravecto 1 Month 560 Mg Fluralaner Chewable Tablets For Very Large Dogs
Active constituent/s: 54.6 g/kg fluralaner
Applicant name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of use: For the treatment and prevention of fleas and ticks in very large dogs
Date of registration: 22 April 2020
Product registration no.: 87859
Label approval no.: 87859/119596
Application no.: 119597
Product name: Bravecto 1 Month 400 Mg Fluralaner Chewable Tablets For Large Dogs
Active constituent/s: 54.6 g/kg fluralaner
Applicant name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of use: For the treatment and prevention of fleas and ticks in large dogs
Date of registration: 22 April 2020
Product registration no.: 87860
Label approval no.: 87860/119597
Application no.: 119598
Product name: Bravecto 1 Month 200 Mg Fluralaner Chewable Tablets For Medium Dogs
Active constituent/s: 54.6 g/kg fluralaner
Applicant name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of use: For the treatment and prevention of fleas and ticks in medium dogs
Date of registration: 22 April 2020
Product registration no.: 87861
Label approval no.: 87861/119598
Application no.: 119599
Product name: Bravecto 1 Month 100 Mg Fluralaner Chewable Tablets For Small Dogs
Active constituent/s: 54.6 g/kg fluralaner
Applicant name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of use: For the treatment and prevention of fleas and ticks in small dogs
Date of registration: 22 April 2020
Product registration no.: 87862
Label approval no.: 87862/119599
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 13
Veterinary Chemical Products and Approved Labels
Application no.: 119600
Product name: Bravecto 1 Month 45 Mg Fluralaner Chewable Tablets For Very Small Dogs
Active constituent/s: 54.6 g/kg fluralaner
Applicant name: Intervet Australia Pty Ltd
Applicant ACN: 008 467 034
Summary of use: For the treatment and prevention of fleas and ticks in very small dogs
Date of registration: 22 April 2020
Product registration no.: 87863
Label approval no.: 87863/119600
Application no.: 124042
Product name: Dyfly Spray-on Sheep Blowfly Treatment
Active constituent/s: 50 g/L dicyclanil
Applicant name: Four Seasons Agribusiness Pty Ltd
Applicant ACN: 115 133 189
Summary of use: For the protection of sheep, either off-shears or with any length wool, against fly strike (caused by dicyclanil-susceptible strains of blowflies (Lucilia cuprina) for 18 to 24 weeks. For the protection of mulesing and marking wounds on sheep against fly strike (caused by dicyclanil -susceptible strains of blowflies (Lucilia cuprina)) during the wound healing process
Date of registration: 23 April 2020
Product registration no.: 89225
Label approval no.: 89225/124042
3. VARIATIONS OF REGISTRATION
Application no.: 124747
Product name: Abatech Ultra Pour-On Roundworm, Liver Fluke & External Parasiticide For Cattle
Active constituent/s: 300 mg/mL triclabendazole, 5 mg/mL abamectin
Applicant name: The Hunter River Company Pty Limited
Applicant ACN: 133 798 615
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Independents Own Abastar Ultra Pour-On Roundworm, Liver Fluke & External Parasiticide for Cattle’ to ‘Abatech Ultra Pour-On Roundworm, Liver Fluke & External Parasiticide for Cattle’, to vary the safety directions and first aid instructions appearing on a label to reflect the current FAISD handbook
Date of variation: 3 April 2020
Product registration no.: 87742
Label approval no.: 87742/124747
Application no.: 124769
Product name: Jurox Apomorphine Emetic Tablets
Active constituent/s: 6.5 mg/Tb apomorphine hydrochloride
Applicant name: Jurox Pty Limited
Applicant ACN: 000 932 230
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Apomorphine Emetic Tablets’ to Jurox Apomorphine Emetic Tablets’
Date of variation: 6 April 2020
Product registration no.: 48380
Label approval no.: 48380/124769
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 14
Veterinary Chemical Products and Approved Labels
Application no.: 124917
Product name: Ovugel (Triptorelin Acetate) Gel For Intravaginal Use In Sows
Active constituent/s: 100 mcg/ml triptorelin (as triptorelin acetate)
Applicant name: Vetoquinol Australia Pty Ltd
Applicant ACN: 006 949 480
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Elanco Ovugel (Triptorelin Acetate) Gel for Intravaginal use in Sows’ to ‘Ovugel (Triptorelin Acetate) Gel for Intravaginal Use in Sows’
Date of variation: 14 April 2020
Product registration no.: 69700
Label approval no.: 69700/124917
4. VARIATION OF LABEL APPROVAL
Application no.: 123792
Product name: All-Trace Trace Element Boluses For Cattle
Active constituent/s: 16509 mg/107g bolus copper (as copper oxide), 249 mg/107g bolus selenium (as sodium selenite), 240 mg/107g bolus cobalt (as cobalt carbonate)
Applicant name: Agrimin Ltd
Applicant ACN: N/A
Summary of variation: Variation of label to update to current Vet Labelling Code
Date of variation: 15 April 2020
Label approval no.: 46326
Application no.: 123978
Product name: Oralbute Oral Paste Anti-inflammatory Analgesic For Horses
Active constituent/s: 200 mg/mL phenylbutazone
Applicant name: Equivet Pty Limited
Applicant ACN: 003 837 492
Summary of variation: To update the withholding period statement and to add a restraint statement
Date of variation: 17 April 2020
Label approval no.: 42362
Application no.: 121538
Product name: Valabarb Euthanasia Solution
Active constituent/s: 300 mg/mL pentobarbitone sodium (equivalent to 273 mg/mL pentobarbitone)
Applicant name: Jurox Pty Limited
Applicant ACN: 000 932 230
Summary of variation: To increase the dose rate from 1–2 ml per 5kg (60–120 mg/kg pentobarbitone sodium) to 1 ml per 2 kg (150 mg/kg pentobarbitone sodium)
Date of variation: 20 April 2020
Label approval no.: 36208
Application no.: 123863
Product name: Starmec Pour-on For Beef And Dairy Cattle
Active constituent/s: 5 g/L ivermectin
Applicant name: The Hunter River Company Pty Limited
Applicant ACN: 133 798 615
Summary of variation: To add an additional 500 mL pack size
Date of variation: 24 April 2020
Label approval no.: 70317
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 15
Veterinary Chemical Products and Approved Labels
Application no.: 124242
Product name: Zeromec Antiparasitic Injection For Cattle
Active constituent/s: 10 mg/mL ivermectin
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of variation: Variation of the product label approval to update the general direction section removing efficacy claims for adult liver fluke
Date of variation: 27 April 2020
Label approval no.: 86233
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 16
Approved Active Constituents
Approved Active Constituents
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals
Code Act 1994, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of
the approval of the following active constituents, with effect from the dates shown.
1. ACTIVE CONSTITUENT
Application no.: 105032
Active constituent/s: Budesonide
Applicant name: Dermcare-Vet Pty Ltd
Applicant ACN: 010 280 010
Summary of use: For use in veterinary chemical products
Date of approval: 14 April 2020
Approval no.: 82110
Application no.: 116463
Active constituent/s: Cross-linked polyacrylamide hydrogel
Applicant name: IMS Vet Pty Ltd
Applicant ACN: 620 774 094
Summary of use: For use in veterinary chemical products
Date of approval: 15 April 2020
Approval no.: 86727
Application no.: 121860
Active constituent/s: Metalaxyl-M
Applicant name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of use: For use in agricultural chemical products
Date of approval: 21 April 2020
Approval no.: 88629
Application no.: 121862
Active constituent/s: Oxadiazon
Applicant name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of use: For use in agricultural chemical products
Date of approval: 21 April 2020
Approval no.: 88631
Application no.: 121697
Active constituent/s: Levamisole
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of use: For use in veterinary chemical products
Date of approval: 23 April 2020
Approval no.: 88560
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 17
New agricultural active constituent: metcamifen
New agricultural active constituent: metcamifen
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has an application for the approval of a new
agricultural active constituent, metcamifen, for use as a herbicide safener applied as a seed treatment in sorghum.
Common name: Metcamifen (ISO)
IUPAC name: 2-Methoxy-N-{4-[(methylcarbamoyl)amino](benzene-1-sulfonyl)}benzamide
Chemical abstracts name: 2-methoxy-N-[[4-[[(methylamino)carbonyl]amino]phenyl]sulfonyl]benzamide
CAS number: 129531-12-0
Molecular formula: C16H17N3O5S
Molecular weight: 363.4 gmol-1
Structure:
Chemical family: Aromatic sulfonamide
SUMMARY OF THE APVMA’S EVALUATION
The APVMA has evaluated the chemistry aspects of metcamifen active constituent (identification, stability,
physicochemical properties, manufacturing process, specifications, quality control procedures, batch analysis results and
analytical methods) and found them to be acceptable.
Impurities of toxicological significance are not expected to occur in metcamifen as a result of the raw materials and the
synthetic route used.
The APVMA has considered the toxicological aspects of metcamifen, and concluded that there are no toxicological
concerns regarding the approval of this active constituent. An Acceptable Daily Intake (ADI) of 0.3 mg/kg bw/d has been
established, along with an Acute Reference Dose (ARfD) of 0.3 mg/kg bw for women of childbearing age. An ARfD was
unnecessary for the general population.
The Scheduling Delegate made a final decision to include metcamifen in Appendix B, Part 3 (substances not requiring
control by scheduling) of the Poisons Standard, with an implementation date of 1 February 2020.
The APVMA is satisfied that the proposed use of metcamifen would not be an undue toxicological hazard to the safety of
people exposed to it during its handling and use.
MAKING A SUBMISSION
In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission
as to whether the application for approval of metcamifen should be granted. Submissions should relate only to matters
that are considered in determining whether the safety criteria set out in section 5A of the Agvet Code have been met.
Submissions should state the grounds on which they are based.
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 18
New agricultural active constituent: metcamifen
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact
listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.
When making a submission please include a:
contact name
company or group name (if relevant)
email or postal address
the date you made the submission.
All personal and confidential commercial information (CCI) material contained in submissions will be treated
confidentially.
Written submissions should be addressed in writing to:
Director of Chemistry and Manufacture
Risk Assessment Capability
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Australia
Phone: +61 2 6770 2300
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 19
New chemical product: EPIVIO C Sorghum Seed Safener containing metcamifen
New chemical product: EPIVIO C Sorghum Seed Safener containing metcamifen
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for registration of a
new product containing a new active constituent. The product is EPIVIO C Sorghum Seed Safener.
PARTICULARS OF THE APPLICATION
Proposed product name(s): EPIVIO C Sorghum Seed Safener
Applicant company: Syngenta Australia Pty Ltd
Name of active constituent: Metcamifen
Signal heading: Unscheduled (Appendix B)
Summary of proposed use: For use as a seed treatment to protect it from the phytotoxic effects of S-
metolachlor.
Pack sizes: 500 mL to 100 L
Withholding period: Harvest: not required when used as directed
Grazing: do not graze or cut for stock food for 6 weeks after planting
SUMMARY OF THE APVMA’S EVALUATION OF EPIVIO C SORGHUM SEED SAFENER IN ACCORDANCE WITH
THE REQUIREMENTS OF SECTION 14(1)(C) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE
(THE ‘AGVET CODE’), SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994
1. The APVMA has evaluated the application and in its assessment in relation to whether the safety criteria have been
met in accordance with the definition set out in section 5A of the Agvet Code, and proposes to determine that:
(i) The APVMA is satisfied that the proposed use of EPIVIO C Sorghum Seed Safener would not be an undue hazard
to the safety of people exposed to it during its handling and use.
(ii) The APVMA is satisfied that the proposed use of EPIVIO C Sorghum Seed Safener will not be an undue hazard to
the safety of people using anything containing its residues.
(iii) The APVMA is satisfied that the proposed use of EPIVIO C Sorghum Seed Safener is not likely to be harmful to
human beings if used according to the product label directions.
(iv) The APVMA is satisfied that the proposed use of EPIVIO C Sorghum Seed Safener is not likely to have an
unintended effect that is harmful to animals, plants or the environment when used according to the product label
directions.
2. The APVMA has evaluated the application and in its assessment in relation to whether the efficacy criteria have
been met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:
(i) In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials
supporting the efficacy of the product adequately demonstrate that, if used according to the product label
directions, the product is effective for its proposed uses.
3. The APVMA has evaluated the application and in its assessment in relation to whether the trade criteria have been
met in accordance with the definition set out in section 5C of the Agvet Code, and proposes to determine that:
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 20
New chemical product: EPIVIO C Sorghum Seed Safener containing metcamifen
(ii) The proposed use of EPIVIO C Sorghum Seed Safener would not adversely affect trade between Australia and
places outside Australia.
FURTHER INFORMATION
A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s public
consultation page, or by contacting the APVMA as listed below.
MAKING A SUBMISSION
In accordance with section 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission
as to whether EPIVIO C Sorghum Seed Safener should be registered. Submissions should relate only to matters that are
required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have
been met. Submissions should state the grounds on which they are based.
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact
listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.
Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and
in determining appropriate conditions of registration and product labelling.
When making a submission please include:
contact name
company or group name (if relevant)
email or postal address
the date you made the submission.
All personal and confidential commercial information (CCI) material contained in submissions will be treated
confidentially.
Written submissions should be addressed in writing to:
Case Management and Administration Unit
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Australia
Phone: +61 2 6770 2300
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 5 May 2020 Agricultural and Veterinary Chemicals Code Act 1994 21
Change to conditions for the export of phorate
Change to conditions for the export of phorate
As required by section 69C(2) of the Agricultural and Veterinary Chemicals (Administration) Act 1992, the
Australian Government Department of Agriculture, Water and the Environment gives notice that the conditions
that apply to the export of the active constituent phorate, or products containing the active constituent phorate,
are changing.
The amendment is required to fulfil Australia’s obligations under the Rotterdam Convention on the Prior Informed
Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (Rotterdam
Convention).
The Rotterdam Convention is an international treaty promoting shared responsibilities and cooperative efforts in
the international trade of certain hazardous chemicals. It creates legally-binding obligations for implementing the
Prior Informed Consent (PIC) procedure. Annex III of the Rotterdam Convention contains a list of chemicals that
are subject to the PIC procedure. The PIC procedure aims to ensure that countries do not export chemicals, for
use as pesticides, to other countries that have not provided their consent to receive them. Exporting parties must
ensure that exports do not occur when the importing country has indicated that it does not consent to imports of
that chemical.
In order to meet export notification requirements under the Rotterdam Convention, anyone seeking to export a
listed chemical must apply to the Department of Agriculture, Water and the Environment for permission to export
the chemical (contact details are at the end of this notice). Anyone exporting listed chemicals to countries that are
parties to the convention must:
(i) include the Harmonised System Customs Code for the chemical (where assigned) on shipping
documentation, which can be found at:
pic.int/TheConvention/Chemicals/HarmonizedSystemCodes/tabid/1159/language/en-US/Default.aspx
(ii) ensure adequate labelling of the chemical including information about
a) risks and/or hazards to human health and the environment
b) compliance with relevant international standards applicable to labels
(iii) provide to the importer (if the chemical is to be used for occupational purposes) a safety data sheet that
follows an internationally recognised format, with the most up to date information available, in one of the
official languages of the importing party
(iv) comply with any specified conditions stipulated by the importing country and promulgated by the secretariat
to the Rotterdam Convention as advised by the authorised officer.
The amendment applies the PIC procedure to all phorate concentrations.
The amendment will not take effect in less than 30 days from the date of this notice.
For further information please contact:
Agvet Chemicals Policy Section
Department of Agriculture, Water and the Environment
Phone: +61 2 6272 5337
Email: [email protected]