APVMA Gazette No. 09, 05 May 2020 · Applicant name: Turf Culture Pty Ltd Applicant ACN: 117 986...

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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

Transcript of APVMA Gazette No. 09, 05 May 2020 · Applicant name: Turf Culture Pty Ltd Applicant ACN: 117 986...

Page 1: APVMA Gazette No. 09, 05 May 2020 · 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

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

Page 2: APVMA Gazette No. 09, 05 May 2020 · 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

© 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

form.

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.

Page 3: APVMA Gazette No. 09, 05 May 2020 · 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

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

Page 4: APVMA Gazette No. 09, 05 May 2020 · 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

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

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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

Page 6: APVMA Gazette No. 09, 05 May 2020 · 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

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

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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

Page 8: APVMA Gazette No. 09, 05 May 2020 · 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

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

Page 9: APVMA Gazette No. 09, 05 May 2020 · 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

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

Page 10: APVMA Gazette No. 09, 05 May 2020 · 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

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

Page 11: APVMA Gazette No. 09, 05 May 2020 · 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

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

Page 12: APVMA Gazette No. 09, 05 May 2020 · 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

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

Page 13: APVMA Gazette No. 09, 05 May 2020 · 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

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

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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

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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

Page 16: APVMA Gazette No. 09, 05 May 2020 · 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

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

Page 17: APVMA Gazette No. 09, 05 May 2020 · 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

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.

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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]

Page 19: APVMA Gazette No. 09, 05 May 2020 · 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

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:

Page 20: APVMA Gazette No. 09, 05 May 2020 · 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

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]

Page 21: APVMA Gazette No. 09, 05 May 2020 · 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

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]