Gazette Agricultural andVeterinary Chemicals
No. APVMA 11, Tuesday, 2 June 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 2023
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 required
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.
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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 GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
CONTENTS
Agricultural Chemical Products and Approved Labels.............................................................................................................
Veterinary Chemical Products and Approved Labels............................................................................................................
Approved Active Constituents................................................................................................................................................
New veterinary active constituent: itraconazole.....................................................................................................................
Amendments to the APVMA MRL Standard..........................................................................................................................
Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code........................................................
Variations to Schedule 20 of the Australia New Zealand Food Standards Code..................................................................
Notice of cancellation at the request of the holder.................................................................................................................
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
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 NEW ACTIVE CONSTITUENTS
Application no.: 123022
Product name: Campbell Sceptre 230SC Fungicide
Active constituent/s: 230 g/L fludioxonil
Applicant name: Colin Campbell (Chemicals) Pty Ltd
Applicant ACN: 000 045 590
Summary of use: For the control of certain disease of recreational turf
Date of registration: 15 May 2020
Product registration no.:
88955
Label approval no.: 88955/123022
Application no.: 118179
Product name: Campbell Poacure Turf Herbicide
Active constituent/s: 240 g/L methiozolin
Applicant name: Colin Campbell (Chemicals) Pty Ltd
Applicant ACN: 000 045 590
Summary of use: For the control of winter grass (Poa annua) in turf
Date of registration: 21 May 2020
Product registration no.:
87357
Label approval no.: 87357/118179
Application no.: 121779
Product name: Surefire Chlorantraniliprole 350 WG Insecticide
Active constituent/s: 350 g/kg chlorantraniliprole
Applicant name: PCT Holdings Pty Ltd
Applicant ACN: 099 023 962
Summary of use: For the control of lepidopteran species of insect pests in cotton and pulse crops
Date of registration: 21 May 2020
Product registration no.:
88598
Label approval no.: 88598/121779
Application no.: 120501
Product name: Trezac Arylex Active Herbicide
Active constituent/s: 30g/L halauxifen present as the methyl ester, 30g/L cloquintocet-mexyl, 25g/L aminopyralid
Applicant name: Dow Agrosciences Australia Limited
Applicant ACN: 003 771 659
Summary of use: For control of broadleaf weeds in winter cereals and fallow, and control of woody weeds in agricultural non-crop areas, commercial and industrial areas, forests, pastures, and rights-of-way
Date of registration: 22 May 2020
Product registration no.:
88180
Label approval no.: 88180/120501
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.: 124030
Product name: Apparent Shaft Herbicide
Active constituent/s: 100 g/L pinoxaden, 25 g/L cloquintocet- mexyl
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of use: For the control of key grass weeds and selective spray topping of wild oats in wheat and barley
Date of registration: 12 May 2020
Product registration no.:
89220
Label approval no.: 89220/124030
Application no.: 119001
Product name: Imtrade Gallardo 900 WG Fungicide
Active constituent/s: 900 g/kg carbendazim
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of use: For the control of fungal diseases in various crops
Date of registration: 12 May 2020
Product registration no.:
87698
Label approval no.: 87698/119001
Application no.: 123531
Product name: Kelpie Oxy-F 240 Herbicide
Active constituent/s: 240 g/L oxyfluorfen
Applicant name: Sinochem International Australia Pty Ltd
Applicant ACN: 160 164 616
Summary of use: For the selective control of certain broadleaf weeds and some grasses
Date of registration: 18 May 2020
Product registration no.:
89064
Label approval no.: 89064/123531
Application no.: 124188
Product name: Hemani Mancozeb 750 WG Fungicide
Active constituent/s: 750 g/kg mancozeb
Applicant name: Hemani Australia Pty Ltd
Applicant ACN: 634 346 357
Summary of use: For the control of certain fungus diseases of fruit, field crops, tobacco, turf, vegetables and ornamentals
Date of registration: 18 May 2020
Product registration no.:
89262
Label approval no.: 89262/124188
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 124182
Product name: Farmalinx Brut Herbicide
Active constituent/s: 525 g/L nonanoic acid
Applicant name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of use: For non-selective control of seedling and young broadleaf and grass weeds, for suppression of established weeds and perennial species and for control of moss and algae
Date of registration: 19 May 2020
Product registration no.:
89257
Label approval no.: 89257/124182
Application no.: 121140
Product name: Surefire Dimethomorph 500 SC Fungicide
Active constituent/s: 500 g/L dimethomorph
Applicant name: PCT Holdings Pty Ltd
Applicant ACN: 099 023 962
Summary of use: For use on various crops to control various fungicidal diseases when mixed with protectant fungicides
Date of registration: 20 May 2020
Product registration no.:
88374
Label approval no.: 88374/121140
Application no.: 124173
Product name: Apparent Pendimethalin 440 Herbicide
Active constituent/s: 440 g/L pendimethalin
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of use: For the control of wireweed, annual grasses (including ryegrass) and certain broadleaved weeds in various crops
Date of registration: 20 May 2020
Product registration no.:
89253
Label approval no.: 89253/124173
Application no.: 124187
Product name: Axiom Gold Plus Fungicide
Active constituent/s: 390 g/kg copper (Cu) present as 600 g/kg copper hydroxide, 50 g/kg metalaxyl-m
Applicant name: Adama Australia Pty Ltd
Applicant ACN: 050 328 973
Summary of use: For the control of various fungal diseases on brassica vegetables, cucumbers, leeks, grapevines, macadamias, potatoes, radishes, swedes, spring onions, turnips and ornamentals
Date of registration: 21 May 2020
Product registration no.:
89261
Label approval no.: 89261/124187
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 121352
Product name: Gharda Triclopyr 600 EC Herbicide
Active constituent/s: 600 g/L triclopyr present as the butoxyethyl ester
Applicant name: Gharda Australia Pty Ltd
Applicant ACN: 087 753 151
Summary of use: For control of woody weeds and melons in a range of situations
Date of registration: 21 May 2020
Product registration no.:
88445
Label approval no.: 88445/121352
Application no.: 121650
Product name: F.S.A. Terbuthylazine 875 WG Herbicide
Active constituent/s: 875 g/kg terbuthylazine
Applicant name: Four Seasons Agribusiness Pty Ltd
Applicant ACN: 115 133 189
Summary of use: For the control of weeds in chickpeas, faba beans, field peas, lentils, lupins, sorghum and triazine tolerant canola
Date of registration: 22 May 2020
Product registration no.:
88546
Label approval no.: 88546/121650
Application no.: 123969
Product name: The Big Cheese Home Choice Rat & Mouse Killer Ready To Use Bait Station
Active constituent/s: 0.025 g/kg difenacoum
Applicant name: Pelgar International (Aus) Pty Ltd
Applicant ACN: 159 699 779
Summary of use: For control of rats and mice in indoor and outdoor household situations
Date of registration: 22 May 2020
Product registration no.:
89203
Label approval no.: 89203/123969
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 123976
Product name: The Big Cheese Home Choice Rat Killer Bait Station
Active constituent/s: 0.025 g/kg difenacoum
Applicant name: Pelgar International (Aus) Pty Ltd
Applicant ACN: 159 699 779
Summary of use: For control of rats in indoor and outdoor household situations
Date of registration: 22 May 2020
Product registration no.:
89206
Label approval no.: 89206/123976
3. VARIATIONS OF REGISTRATION
Application no.: 125242
Product name: Final Banquet Mouse Bait
Active constituent/s: 25 g/kg zinc phosphide
Applicant name: Agroserve Pty Ltd
Applicant ACN: 163 422 464
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Final Feast Mouse Bait’ to ‘Final Banquet Mouse Bait’
Date of variation: 5 May 2020
Product registration no.:
86877
Label approval no.: 86877/125242
Application no.: 125248
Product name: Chemron Sentinel Automatically Dispensed Pyrethrum Insecticide Spray
Active constituent/s: 45 g/kg piperonyl butoxide, 9 g/kg pyrethrins
Applicant name: Chemlux Pty Ltd
Applicant ACN: 626 183 060
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Cyndan Sentinel Automatically Dispensed Pyrethrum Insecticide’ to ‘Chemron Sentinel Automatically Dispensed Pyrethrum Insecticide Spray’
Date of variation: 6 May 2020
Product registration no.:
54165
Label approval no.: 54165/125248
Application no.: 125246
Product name: Chemron Wasp Eliminator Insecticide
Active constituent/s: 1.3 g/kg d-allethrin, 1.2 g/kg d-phenothrin
Applicant name: Chemlux Pty Ltd
Applicant ACN: 626 183 060
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Cyndan Wasp Eliminator Insecticide’ to ‘Chemron Wasp Eliminator Insecticide’
Date of variation: 6 May 2020
Product registration no.:
60519
Label approval no.: 60519/125246
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 125254
Product name: Campbell Absolve Peracetic Acid Biocide
Active constituent/s: 160 g/L peroxyacetic acid, 110 g/L hydrogen peroxide
Applicant name: Colin Campbell (Chemicals) Pty Ltd
Applicant ACN: 000 045 590
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Campbell Perasan Peracetic Acid Biocide’ to ‘Campbell Absolve Peracetic Acid Biocide’
Date of variation: 7 May 2020
Product registration no.:
87664
Label approval no.: 87664/125254
Application no.: 125303
Product name: Chemron Algae-Died 'B' For Killing Algae And Black Spot
Active constituent/s: 142.5 g/L quaternary ammonium compound
Applicant name: Chemlux Pty Ltd
Applicant ACN: 626 183 060
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Cyndan Algae-Died 'B' For Killing Algae And Black Spot’ to ‘Chemron Algae-Died 'B' For Killing Algae And Black Spot’ and to add pack sizes
Date of variation: 11 May 2020
Product registration no.:
47349
Label approval no.: 47349/125303
Application no.: 124402
Product name: Bushman Plus Personal Insect Repellent Pump Spray
Active constituent/s: 200g/L diethyltoluamide, 11g/L N-octyl bicycloheptene dicarboximide
Applicant name: Juno Limited
Applicant ACN: N/A
Summary of variation:
Remove di-n-propyl isocinchomeronate from the ingredients in the formulation
Date of variation: 12 May 2020
Product registration no.:
69463
Label approval no.: 69463/124402
Application no.: 120030
Product name: Conquest Glisarin 704 Spray Adjuvant
Active constituent/s: 704 g/L ethyl and methyl esters of canola oil fatty acids
Applicant name: Conquest Crop Protection Pty Ltd
Applicant ACN: 098 814 932
Summary of variation:
To include additional use patterns
Date of variation: 12 May 2020
Product registration no.:
61791
Label approval no.: 61791/120030
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 123842
Product name: Eezi Pool Shock Treatment
Active constituent/s: 650 g/kg chlorine (Cl) present as calcium hypochlorite
Applicant name: Eezi Pool Australia Pty Ltd
Applicant ACN: 632 990 320
Summary of variation:
To change the name from ‘Eezi Pool Eezi Pool Shock Treatment’ to ‘Eezi Pool Shock Treatment’
Date of variation: 12 May 2020
Product registration no.:
85069
Label approval no.: 85069/123842
Application no.: 125319
Product name: Chemron Glyphocyde 450 Weedkiller
Active constituent/s: 450 g/L glyphosate present as the isopropylamine salt
Applicant name: Chemlux Pty Ltd
Applicant ACN: 626 183 060
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Cyndan Glyphocyde 450 Weedkiller’ to ‘Chemron Glyphocyde 450 Weedkiller’ and to add pack sizes
Date of variation: 12 May 2020
Product registration no.:
46086
Label approval no.: 46086/125319
Application no.: 125314
Product name: Hy-Clor Super-Shock Granular Pool Chlorine
Active constituent/s: 700 g/kg available chlorine (Cl) present as calcium hypochlorite
Applicant name: Hy-Clor (Australia) Pty Ltd
Applicant ACN: 000 655 381
Summary of variation:
To vary the name that appears on the label from ‘Swimgo Shock Treatment’ to ‘Swim ABC Shock Treatment’
Date of variation: 12 May 2020
Product registration no.:
56110
Label approval no.: 56110/125314
Application no.: 125320
Product name: Hy-Clor Long Lasting Swimming Pool Tablets
Active constituent/s: 850 g/kg available chlorine (Cl) present as trichloroisocyanuric acid
Applicant name: Hy-Clor (Australia) Pty Ltd
Applicant ACN: 000 655 381
Summary of variation:
To vary the name that appears on the label from ‘Swimgo Multi Tablets’ to ‘Swim ABC Multi Tablets’
Date of variation: 12 May 2020
Product registration no.:
56112
Label approval no.: 56112/125320
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 125329
Product name: Hy-Clor Long Lasting Swimming Pool Tablets
Active constituent/s: 850 g/kg available chlorine (Cl) present as trichloroisocyanuric acid
Applicant name: Hy-Clor (Australia) Pty Ltd
Applicant ACN: 000 655 381
Summary of variation:
To vary the name that appears on the label from ‘Swimgo Long Lasting Swimming Pool Tablets’ to ‘Swim ABC Long Lasting Swimming Pool Tablets’
Date of variation: 12 May 2020
Product registration no.:
56112
Label approval no.: 56112/125329
Application no.: 125330
Product name: Hy-Clor Granular Pool Chlorine
Active constituent/s: 650 g/kg available chlorine (Cl) present as calcium hypochlorite
Applicant name: Hy-Clor (Australia) Pty Ltd
Applicant ACN: 000 655 381
Summary of variation:
To vary the name that appears on the label from ‘Swimgo Granular Chlorine’ to ‘Swim ABC Granular Chlorine’
Date of variation: 12 May 2020
Product registration no.:
56157
Label approval no.: 56157/125330
Application no.: 125331
Product name: Hy-Clor Liquid Chlorine
Active constituent/s: 125 g/L available chlorine (Cl) present as sodium hypochlorite
Applicant name: Hy-Clor (Australia) Pty Ltd
Applicant ACN: 000 655 381
Summary of variation:
To vary the name that appears on the label from ‘Swimgo Liquid Chlorine’ to ‘Swim ABC Liquid Chlorine’
Date of variation: 12 May 2020
Product registration no.:
66166
Label approval no.: 66166/125331
Application no.: 125333
Product name: Hy-Clor Algaecide
Active constituent/s: 150 g/L benzalkonium chloride
Applicant name: Hy-Clor (Australia) Pty Ltd
Applicant ACN: 000 655 381
Summary of variation:
To vary the name that appears on the label from ‘Swimgo Algaecide’ to ‘Swim ABC Algaecide’
Date of variation: 12 May 2020
Product registration no.:
66276
Label approval no.: 66276/125333
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 125334
Product name: Hy-Clor 3 In 1 Concentrated Pool Chlorine
Active constituent/s: 560 g/kg chlorine (Cl) present as sodium dichloroisocyanurate dihydrate
Applicant name: Hy-Clor (Australia) Pty Ltd
Applicant ACN: 000 655 381
Summary of variation:
To vary the name that appears on the label from ‘Swimgo 3 In 1 Granular Pool Chlorine’ to ‘Swim ABC 3 In 1 Granular Pool Chlorine’
Date of variation: 12 May 2020
Product registration no.:
66084
Label approval no.: 66084/125334
Application no.: 124055
Product name: Titan Methomyl 225 Insecticide
Active constituent/s: 593 g/L methanol, 225 g/L methomyl
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of variation:
To add use in lettuce
Date of variation: 13 May 2020
Product registration no.:
69047
Label approval no.: 69047/124055
Application no.: 125340
Product name: Combat Roach-Rid Roach Killing Bait Strips
Active constituent/s: 0.1 g/kg fipronil
Applicant name: Henkel Australia Pty Ltd
Applicant ACN: 001 302 996
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Combat Roach Killing Bait Strips’ to ‘Combat Roach-Rid Roach Killing Bait Strips’
Date of variation: 13 May 2020
Product registration no.:
70308
Label approval no.: 70308/125340
Application no.: 125335
Product name: Gardenline Weed Terminator RTU
Active constituent/s: 90 g/L acetic acid
Applicant name: Amgrow Pty Ltd
Applicant ACN: 100 684 786
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Gardenline Weed Terminator’ to ‘Gardenline Weed Terminator RTU’
Date of variation: 13 May 2020
Product registration no.:
88254
Label approval no.: 88254/125335
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 124263
Product name: Suspectin 18EC Insecticide/Miticide
Active constituent/s: 18 g/L abamectin
Applicant name: Ruralco Holdings Limited
Applicant ACN: 009 660 879
Summary of variation:
To add use in lettuce, snow peas, sugar snap peas, cultivated mushrooms, citrus trees, rhubarb, duboisia, raspberry, blackberry, blackcurrant, papaya (pawpaw), blueberries, sweet corn, chillies, paprika, spring onions and shallots, avocadoes, passionfruit, capsicum, cucumber, eggplant, zucchini, tomato, citrus, mung bean, adzuki bean, navy bean, tea tree oil, custard apples, nursery stock, cut flowers and litchi as part of the permit to label project
Date of variation: 13 May 2020
Product registration no.:
83210
Label approval no.: 83210/124263
Application no.: 124062
Product name: Bollgard 3
Active constituent/s: Bacillus thuringiensis subsp. kurstaki delta endotoxins as produced by the Cry1Ac and Cry2Ab genes and their controlling sequences, bacillus thuringiensis strain AB88 exotoxin as produced by the Vip3A(a) gene and its controlling sequence
Applicant name: Monsanto Australia Pty Ltd
Applicant ACN: 006 725 560
Summary of variation:
To vary the conditions of registration and associate resistance management plans
Date of variation: 13 May 2020
Product registration no.:
69656
Label approval no.: 69656/124062
Application no.: 124078
Product name: 4Farmers Prosulfocarb Herbicide
Active constituent/s: 800 g/L prosulfocarb
Applicant name: 4 Farmers Australia Pty Ltd
Applicant ACN: 160 092 428
Summary of variation:
To include early post-emergence application for the control of annual ryegrass in wheat and barley
Date of variation: 14 May 2020
Product registration no.:
82536
Label approval no.: 82536/124078
Application no.: 124068
Product name: Accensi Abamectin Insecticide
Active constituent/s: 18 g/L abamectin
Applicant name: Accensi Pty Ltd
Applicant ACN: 079 875 184
Summary of variation:
To add use in lettuce, snow peas, sugar snap peas, cultivated mushrooms, citrus trees, rhubarb, duboisia, raspberry, blackberry, blackcurrant, papaya (pawpaw), blueberries, sweet corn, chillies, paprika, spring onions and shallots, avocadoes, passionfruit, capsicum, cucumber, eggplant, zucchini, tomato, citrus, mung bean, adzuki bean, navy bean, tea tree oil, custard apples, nursery stock, cut flowers and litchi as part of the permit to label project
Date of variation: 14 May 2020
Product registration no.:
53080
Label approval no.: 53080/124068
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 125343
Product name: Combat Ant-Rid Indoor Ant Liquid Relief From Tough Ant Problems
Active constituent/s: 11.83 g/L boron (B) present as 104.4 g/l borax decahydrate
Applicant name: Henkel Australia Pty Ltd
Applicant ACN: 001 302 996
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Combat Ant-Rid Relief From Tough Ant Problems Indoor Ant Liquid’ to ‘Combat Ant-Rid Indoor Ant Liquid Relief From Tough Ant Problems’. To vary the instructions for storage and disposal of containers or products, in line with the relevant requirements for the type of container as specified in the Agricultural Labelling Code made by the APVMA
Date of variation: 14 May 2020
Product registration no.:
50920
Label approval no.: 50920/125343
Application no.: 124359
Product name: Bushman Repellent Plus Personal Insect Repellent
Active constituent/s: 200 g/kg diethyltoluamide, 11 g/kg N-octyl bicycloheptene dicarboximide
Applicant name: Juno Limited
Applicant ACN: N/A
Summary of variation:
Remove di-n-propyl isocinchomeronate from the ingredients in the formulation
Date of variation: 15 May 2020
Product registration no.:
47106
Label approval no.: 47106/124359
Application no.: 122231
Product name: Boxer Gold Herbicide
Active constituent/s: 800 g/L prosulfocarb, 120 g/L S-metolachlor
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of variation:
To include a new early post-emergent rate in wheat and barley
Date of variation: 15 May 2020
Product registration no.:
61234
Label approval no.: 61234/122231
Application no.: 124116
Product name: Barmac Abamectin Insecticide
Active constituent/s: 18 g/L abamectin
Applicant name: Amgrow Pty Ltd
Applicant ACN: 100 684 786
Summary of variation:
To add use in lettuce, snow peas, sugar snap peas, cultivated mushrooms, citrus trees, rhubarb, duboisia, raspberry, blackberry, blackcurrant, papaya (pawpaw), blueberries, sweet corn, chillies, paprika, spring onions and shallots, avocadoes, passionfruit, capsicum, cucumber, eggplant, zucchini, tomato, citrus, mung bean, adzuki bean, navy bean, tea tree oil, custard apples, nursery stock, cut flowers and litchi as part of the permit to label project
Date of variation: 18 May 2020
Product registration no.:
83173
Label approval no.: 83173/124116
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 123544
Product name: Roundup Ultra Max Herbicide
Active constituent/s: 570 g/L glyphosate present as the potassium salt
Applicant name: Monsanto Australia Pty Ltd
Applicant ACN: 006 725 560
Summary of variation:
To add pre-harvest use in barley as a harvest aid and weed control
Date of variation: 18 May 2020
Product registration no.:
68506
Label approval no.: 68506/123544
Application no.: 123799
Product name: Kenso Agcare Indy 150 OD Insecticide
Active constituent/s: 200 g/L indoxacarb (3:1), sufficient to give 150 g/L of the active S-indoxacarb isomer
Applicant name: Kenso Corporation (M) Sdn Bhd
Applicant ACN: N/A
Summary of variation:
To include control of lepidopteran species of insect pests in certain vegetable crops
Date of variation: 18 May 2020
Product registration no.:
88131
Label approval no.: 88131/123799
Application no.: 124061
Product name: Campbell Fludy 230SC Fungicide
Active constituent/s: 230 g/L fludioxonil
Applicant name: Colin Campbell (Chemicals) Pty Ltd
Applicant ACN: 000 045 590
Summary of variation:
To add the following use instructions: suppression of surface moulds and fungal rots in chestnuts; and post-harvest moulds in pineapple to product containing 230 g/L fludioxonil
Date of variation: 19 May 2020
Product registration no.:
83843
Label approval no.: 83843/124061
Application no.: 124077
Product name: Vivus Armigen Helicoverpa Biocontrol
Active constituent/s: 7.5 x 109 polyhedral inclusion bodies of the nucleopolyhedrovirus of Helicoverpa armigera per millilitre
Applicant name: AgBiTech Pty Ltd
Applicant ACN: 146 400 160
Summary of variation:
To change the product name from ‘Armigen Helicoverpa Biocontrol’ to ‘Vivus Armigen Helicoverpa Biocontrol’
Date of variation: 19 May 2020
Product registration no.:
70336
Label approval no.: 70336/124077
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 124165
Product name: Starling Fungicide
Active constituent/s: 230 g/L fludioxonil
Applicant name: Grochem Australia Pty Ltd
Applicant ACN: 169 400 033
Summary of variation:
To add suppression of surface moulds and fungal rots in chestnuts; and post-harvest moulds in pineapple as part of the permit to label project
Date of variation: 21 May 2020
Product registration no.:
84680
Label approval no.: 84680/124165
Application no.: 121820
Product name: Genfarm Diclofop-Methyl 375 Selective Herbicide
Active constituent/s: 375 g/L diclofop-methyl
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of variation:
To add an additional formulation
Date of variation: 22 May 2020
Product registration no.:
59527
Label approval no.: 59527/121820
4. VARIATION OF LABEL APPROVAL
Application no.: 125332
Product name: Hyclor Long Life Algaecide
Active constituent/s: 40 g/L copper (Cu) present as a cupric ammonium complex
Applicant name: Hy-Clor (Australia) Pty Ltd
Applicant ACN: 000 655 381
Summary of variation:
To vary the name that appears on the label from ‘Swimgo Long Life Algaecide’ to ‘Swim ABC Long Life Algaecide’
Date of variation: 12 May 2020
Product registration no.:
59579
Label approval no.: 59579/125332
Application no.: 120848
Product name: Farmalinx Oat Master Herbicide
Active constituent/s: 90 g/L flamprop-m-methyl
Applicant name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of variation:
To increase the application growth stage window for desi variety chickpeas
Date of variation: 21 May 2020
Product registration no.:
69871
Label approval no.: 69871/120848
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
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.: 100621
Product name: FelineGuard FeLV
Active constituent/s: Each 1 mL dose contains inactivated feline leukaemia virus (FeLV) subtypes A, B and C (Kawakami-Theilen strain) including gp70 sub-unit antigen
Applicant name: Zoetis Australia Pty Ltd
Applicant ACN: 156 476 425
Summary of use: Registration of a 218.4 ug/m L inactivated feline leukaemia virus subtypes A, B and C (Kawakami-Theilen strain) and gp70 sub-unit antigen product to protect susceptible cats against persistent feline leukaemia virus (FeLV) infection and associated clinical disease
Date of registration: 12 May 2020
Product registration no.:
80322
Label approval no.: 80322/100621
2. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.: 123823
Product name: Multitrace Injection For Cattle
Active constituent/s: 40 g/L zinc as disodium zinc EDTA, 15 g/L copper as disodium copper EDTA, 10 g/L manganese as disodium manganese EDTA, 5 g/L selenium as sodium selenite
Applicant name: Intervet Australia Pty Ltd
Applicant ACN: 008 467 034
Summary of use: For the registration of an injectable solution for use in cattle deficient in and/or responsive to manganese, zinc, selenium and/or copper supplementation
Date of registration: 15 May 2020
Product registration no.:
89168
Label approval no.: 89168/123823
Application no.: 124063
Product name: Imperial Pour-On Fly And Lice Treatment For Cattle And Horses
Active constituent/s: 15 g/L deltamethrin
Applicant name: WSD Agribusiness Pty Ltd
Applicant ACN: 600 111 135
Summary of use: For control of stable fly (Stomoxys calcitrans), house fly (Musca domestica), and lice (Bovicola bovis, Linognathus vituli and Haematopinus eurysternus) and synthetic pyrethroid susceptible buffalo fly (Haematobia irritans exigua) on beef and dairy cattle. For control of synthetic pyrethroid susceptible buffalo fly (Haematobia irritans exigua) for up to 3 weeks and for control of stable fly (Stomoxys calcitrans) for up to 1 week on horses. Provides protection from Culicoides brevitarsus for at least 14 days with effective control of blood feeding C.brevitarsus for 6 days post treatment
Date of registration: 15 May 2020
Product registration no.:
89229
Label approval no.: 89229/124063
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
3. VARIATIONS OF REGISTRATION
Application no.: 119900
Product name: Gleptosil Iron Injection
Active constituent/s: 463 mg/mL gleptoferron equivalent to elemental iron 200 mg/mL
Applicant name: Ceva Animal Health Pty Ltd
Applicant ACN: 002 692 426
Summary of variation:
To vary the product registration and label approval to add a new pack size, packaging and to update the shelf life and storage conditions
Date of variation: 12 May 2020
Product registration no.:
52474
Label approval no.: 52474/119900
Application no.: 125338
Product name: Pastoral Ag Iverlab Blowfly And Lice Jetting Fluid For Sheep
Active constituent/s: 16 g/L ivermectin
Applicant name: The Hunter River Company Pty Ltd
Applicant ACN: 133 798 615
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Pastoral Ag Ivermectin Blowfly and Lice Jetting Fluid For Sheep’ to ‘Pastoral Ag Iverlab Blowfly And Lice Jetting Fluid For Sheep’
Date of variation: 13 May 2020
Product registration no.:
88811
Label approval no.: 88811/125338
Application no.: 125339
Product name: Pastoral Ag Eprinolab Pour-On For Beef And Dairy Cattle
Active constituent/s: 5 mg/mL eprinomectin
Applicant name: The Hunter River Company Pty Ltd
Applicant ACN: 133 798 615
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Pastoral Ag Eprinomectin Pour-On For Beef And Dairy Cattle’ to ‘Pastoral Ag Eprinolab Pour-On For Beef And Dairy Cattle’
Date of variation: 13 May 2020
Product registration no.:
88823
Label approval no.: 88823/125339
Application no.: 125341
Product name: Pastoral Ag Iverlab LV Pour-On For Cattle
Active constituent/s: 10 g/L ivermectin
Applicant name: The Hunter River Company Pty Ltd
Applicant ACN: 133 798 615
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Pastoral Ag Ivermectin LV Pour-On For Cattle’ to ‘Pastoral Ag Iverlab LV Pour-On For Cattle’
Date of variation: 13 May 2020
Product registration no.:
88831
Label approval no.: 88831/125341
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 119860
Product name: Websters 5 In 1 Se Vaccine
Active constituent/s: 5.0 IU/mL clostridium perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. tetani, 2.5 IU/mL Cl. septicum, ≥ 0.15% pcv/mL Cl. chauvoei, 0.5mg/mL selenium as sodium selenate
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of variation:
To vary the product registration and label approval to update relevant particulars
Date of variation: 14 May 2020
Product registration no.:
47952
Label approval no.: 47952/119860
Application no.: 119864
Product name: Cydectin Weanerguard SE B12 6 In 1 Vaccine And Wormer With Selenium And Vitamin B12 For Sheep
Active constituent/s: 5.0 IU/mL Cl. perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. septicum, 2.5 mg/mL moxidectin, 2.5 IU/mL Cl. tetani, 1.0 mg/mL vitamin B12 (hydroxocobalamin acetate), 1.0 U/mL C. pseudotuberculosis (ovis), ≥ 0.15% pcv/mL Cl. chauvoei, 0.5 mg/mL selenium as sodium selenate
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of variation:
Variation of product registration and label approval to update relevant particulars
Date of variation: 14 May 2020
Product registration no.:
59350
Label approval no.: 59350/119864
Application no.: 119867
Product name: Cydectin Eweguard SE B12 6 In 1 Vaccine And Wormer With Selenium And Vitamin B12 For Sheep
Active constituent/s: 5.0 mg/mL moxidectin, 5.0 IU/mL Cl. perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. septicum, 2.5 IU/mL Cl. tetani, 1.0 U/mL C. pseudotuberculosis (ovis),1 mg/mL vitamin B12 (hydroxocobalamin acetate), ≥ 0.15% pcv/mL Cl. chauvoei, 1.0 mg/mL selenium as sodium selenate
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of variation:
To vary the product registration and label approval to update relevant particulars
Date of variation: 14 May 2020
Product registration no.:
58527
Label approval no.: 58527/119867
Application no.: 119868
Product name: Cydectin Eweguard 6 In 1 Vaccine And Wormer For Sheep
Active constituent/s: 5.0 g/L moxidectin, 5.0 IU/mL Cl. perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. septicum, 2.5 IU/mL Cl. tetani, 1.0 U/mL C. pseudotuberculosis (ovis), ≥ 0.15% pcv/mL Cl. chauvoei
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of variation:
To vary the product registration and label approval to update relevant particulars
Date of variation: 14 May 2020
Product registration no.:
47607
Label approval no.: 47607/119868
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 119866
Product name: Cydectin Weanerguard 6 In 1 Vaccine And Wormer For Sheep
Active constituent/s: 5.0 IU/mL Cl. perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 g/L moxidectin, 2.5 IU/mL Cl. septicum, 2.5 IU/mL Cl. tetani, 1.0 U/mL c. pseudotuberculosis (ovis), ≥ 0.15% pcv/mL Cl. chauvoei
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of variation:
To vary the product registration and label approval to update relevant particulars
Date of variation: 14 May 2020
Product registration no.:
47608
Label approval no.: 47608/119866
Application no.: 121964
Product name: NV Pentosan Gold Injection For Horses
Active constituent/s: 200 mg/mL acetyl glucosamine, 125 mg/mL pentosan polysulfate sodium
Applicant name: Ceva Animal Health Pty Ltd
Applicant ACN: 002 692 426
Summary of variation:
To add an additional 50 mL pack size to the registered product NV Pentosan Gold Injection For Horses
Date of variation: 19 May 2020
Product registration no.:
63195
Label approval no.: 63195/121964
Application no.: 124202
Product name: Coopers Cattlevax LC 7 In 1 Leptospiral And Clostridial Vaccine For Beef, Dairy Cattle And Calves
Active constituent/s: 5.0 IU/mL Clostridium perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. septicum, 2.5 IU/mL Cl. tetani, 0.5 x 109 org/mL Leptospira interrogans serovar Hardjo, 0.5 x 109 org/mL Leptospira interrogans serovar pomona, ≥ 0.15% pcv/mL Cl. chauvoei
Applicant name: Intervet Australia Pty Ltd
Applicant ACN: 008 467 034
Summary of variation:
To vary the product registration and label approval to update relevant particulars
Date of variation: 20 May 2020
Product registration no.:
53206
Label approval no.: 53206/124202
Application no.: 121840
Product name: Allfarm Piperazine Wormer For Poultry
Active constituent/s: 530 mg/g piperazine as piperazine dihydrochloride
Applicant name: Parafarm Pty Ltd
Applicant ACN: 161 661 696
Summary of variation:
To update the label particulars by addition of a new pack size
Date of variation: 21 May 2020
Product registration no.:
45124
Label approval no.: 45124/121840
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
4. LABEL APPROVAL
Application no.: 124117
Product name: Ilium Meloxicam Anti-Inflammatory Oral Suspension For Dogs
Active constituent/s: 1.5 mg/mL meloxicam
Applicant name: Troy Laboratories Pty Ltd
Applicant ACN: 000 283 769
Summary of variation:
To update label
Date of variation: 19 May 2020
Product registration no.:
60023
Label approval no.: 60023/124117
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
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.: 123020
Active constituent/s:
Meloxicam
Applicant name: South Yarra Pharma Pty Ltd
Applicant ACN: 629 173 351
Summary of use: For use in veterinary chemical products
Date of approval: 12 May 2020
Approval no.: 88953
Application no.: 123030
Active constituent/s:
Oxytetracycline dihydrate
Applicant name: South Yarra Pharma Pty Ltd
Applicant ACN: 629 173 351
Summary of use: For use in veterinary chemical products
Date of approval: 13 May 2020
Approval no.: 88961
Application no.: 118178
Active constituent/s:
Methiozolin
Applicant name: Colin Campbell (Chemicals) Pty Ltd
Applicant ACN: 000 045 590
Summary of use: For use in agricultural chemical products
Date of approval: 21 May 2020
Approval no.: 87356
Application no.: 122078
Active constituent/s:
Pinoxaden
Applicant name: Foison Scitech Co Limited
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 22 May 2020
Approval no.: 88716
Application no.: 122088
Active constituent/s:
Clethodim
Applicant name: Sinochem Agro Co Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 22 May 2020
Approval no.: 88720
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
2. VARIATIONS OF ACTIVE CONSTITUENT
Application no.: 123038
Active constituent/s:
Chlorpheniramine maleate
Applicant name: Jurox Pty Ltd
Applicant ACN: 000 932 230
Summary of variation:
Variation of relevant particulars or conditions of an approved active constituent
Date of variation: 14 May 2020
Approval no.: 54859
Application no.: 125301
Active constituent/s:
Morantel citrate monohydrate
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of variation:
Variation of relevant particulars or conditions of an approved active constituent
Date of variation: 19 May 2020
Approval no.: 83043
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
New veterinary active constituent: itraconazole
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new veterinary active constituent, itraconazole, for use in the treatment of fungal infections in companion animals.
Common name: Itraconazole
IUPAC name: 1-((2RS)-Butan-2-yl)-4-{4-[4-(4-{[(2RS,4SR)-2-(2,4-dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one
Chemical abstracts name: rel-4-[4-[4-[4[[(2R,4S)2-(2, 4-Dichlorophenyl)-2-(1H-1, 2,4-triazol-1-ylmethyl)-1, 3-dioxolan-4-yl] methoxy] phenyl]-1-piperazinyl]phenyl]-2, 4-dihydro-2-(1-methylpropyl)-3H-1,2, 4-triazol-3-one
CAS number: 84625-61-6
Molecular formula: C35H38Cl2N8O4
Molecular weight: 705.64 g/mol
Structure:
Chemical family: Synthetic triazole compound
Mode of action: Inhibition of cytochrome P450 enzymes and decreasing fungal ergosterol synthesis and/or affecting their metabolism
SUMMARY OF THE APVMA’S EVALUATION
The APVMA has evaluated the chemistry aspects of itraconazole active constituent (identification, physicochemical properties, manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.
Itraconazole will be manufactured to the standard of the British Pharmacopoeia monograph.
Impurities of toxicological significance are not expected to occur in itraconazole as a result of the raw materials and the synthetic route used.
The APVMA has considered the toxicological aspects of itraconazole, and concluded that there are no toxicological concerns to the approval of this active constituent. As there are currently no proposed uses in food producing animals, neither an Acceptable Daily Intake (ADI) nor an Acute Reference Dose (ARfD) has been established.
As a result of its use in human pharmaceuticals, itraconazole is already included in Schedule 4 of the Poison Standard, and this listing remains appropriate.
The APVMA is satisfied that the proposed importation and use of itraconazole would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use.
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
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 itraconazole 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.
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 (if available) the date you made the submission.
All personal and confidential commercial information (CCI)1 material contained in submissions will be treated confidentially.
Written submissions should be addressed in writing to:
Director of Chemistry and ManufactureRisk Assessment CapabilityAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001
Phone: +61 2 6770 2300Email: [email protected]
1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Amendments to the APVMA MRL Standard
The Australian Pesticides and Veterinary Medicines Authority (APVMA) approves maximum residue limits (MRLs) of agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. The MRLs approved by the APVMA are associated with a regulatory decision to register a product, grant a permit approval, or as an outcome from a review decision and are set out in the Agricultural and Veterinary Chemicals Code (MRL Standard) Instrument 2019. The MRL Standard lists MRLs of substances that may arise from the approved use of agricultural and veterinary chemical products containing those substances on commodities used for human consumption as well as livestock feeds. The MRL Standard also provides the relevant residue definitions to which these MRLs apply. There may be situations where the residue definition for monitoring and enforcement is different to the definition used for dietary risk assessment purposes.
MRLs are set at levels which are not likely to be exceeded if the agricultural or veterinary chemicals are used in accordance with approved label instructions. In considering MRLs and variation to MRLs, the APVMA takes into account studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice and dietary exposure. In approving MRLs, the APVMA is satisfied, from dietary exposure assessment, that the levels set are not an undue hazard to human health.
The APVMA has amended the MRL Standard and the changes will have affect the day after the instrument is registered.
Details of the amendment can be found in the Agricultural and Veterinary Chemicals Code (MRL Standard) Amendment Instrument (No. 4) 2020
The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code (MRL Standard) Instrument 2019.
The MRL Standard is accessible via the Federal Register of Legislation website.
For further information please contact:
MRL Contact Officer Australian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001
Phone: +61 2 6770 2401Email: [email protected]
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code
In the previous notice on page 25 of APVMA Gazette No. 11, the APVMA gazetted amendments which it has approved to vary maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in the APVMA’s MRL Standard.
Under section 82 of the Food Standards Australia New Zealand Act 1991, the APVMA is proposing to incorporate those variations (Agricultural and Veterinary Chemicals Code (MRL Standard) Amendment Instrument (No. 4) 2020) to MRLs into Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code.
MRLs contained in Schedule 20 provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this means, Schedule 20 permits the sale of treated foods and protects public health and safety by minimising residues in foods consistent with the effective control of pests and diseases.
The APVMA and Food Standards Australia New Zealand (FSANZ) are satisfied, based on dietary exposure assessments and current health standards, that the proposed limits are not harmful to public health.
The agreement between the Australian Government and the New Zealand Government concerning a Joint Food Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.
A Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO) will be made.
The APVMA invites comment on these proposals. Details on how to make a submission appear near the end of this notice, below the details of the proposed amendment.
The APVMA will consider any public comments made in response to this proposal. If the APVMA decides to proceed with the proposal, it will further notify any variations it makes to Schedule 20 in the APVMA Gazette. The variations will take effect as from the date of that subsequent notice.
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
PROPOSED VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE (19 May 2020)Note: Subsection 82(2) of the Food Standards Australia New Zealand Act 1991 provides that variations to standards are legislative instruments, but are not subject to disallowance or sunsetting.
To commence: on gazettal of variation
[1] The table to section S20–3 in Schedule 20 is varied by
[1.1] inserting in alphabetical order
Agvet chemical: aclonifen
Permitted residue: aclonifenBarley T*0.01Edible offal (mammalian) T*0.01Eggs T*0.01Meat (mammalian) T*0.01Milks T*0.01Poultry meat T*0.01Poultry, edible offal of T*0.01Triticale T*0.01Wheat T*0.01
Agvet chemical: metcamifen
Permitted residue—commodities of plant origin: metcamifenPermitted residue—commodities of animal origin: sum of metcamifen and 4-(3-methyl-ureido)-benzensulfonamide, expressed as metcamifenEdible offal (mammalian) *0.03Eggs *0.03Meat (mammalian) *0.03Milks *0.03Poultry, edible offal of *0.03Poultry meat *0.03Sorghum *0.01
[1.2] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order
Agvet chemical: azoxystrobin
Permitted residue: azoxystrobin
Rye 0.1Triticale 0.1
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Agvet chemical: chlorantraniliprole
Permitted residue—plant commodities and animal commodities other than milk: chlorantraniliprolePermitted residue—milk: sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliproleMaize cereals T*0.01Sugar cane T0.5
Agvet chemical: cyproconazole
Permitted residue: cyproconazole, sum of isomersOats 0.05Rye *0.02Triticale *0.02
Agvet chemical: emamectin
Permitted residue: sum of emamectin B1a and emamectin B1bMaize cereals T*0.01Wheat, similar grains, and pseudocereals without husks
T*0.01
Agvet chemical: etoxazole
Permitted residue: etoxazole
Cane berries T0.5
Agvet chemical: flonicamid
Permitted residue: flonicamid [N -(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide] and its metabolites TFNA [4-trifluoromethylnicotinic acid], TFNA-AM [4-trifluoromethylnicotinamide] TFNG [N -(4-trifluoromethylnicotinoyl)glycine]
Blackberries T2Bulb vegetables T0.2Raspberries, red, black T2
Agvet chemical: fludioxonil
Permitted residue—commodities of animal origin: sum of fludioxonil and oxidisable metabolites, expressed as fludioxonilPermitted residue—commodities of plant origin: fludioxonil
Eggs T*0.01Poultry meat T*0.01Poultry, edible offal of T*0.01
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Pulses T0.1
Agvet chemical: indoxacarb
Permitted residue: sum of indoxacarb and its R-isomerMaize cereals T*0.01Peppers 0.5
Agvet chemical: linuron
Permitted residue: sum of linuron plus 3,4-dichloroaniline, expressed as linuronCoriander (leaves, roots, stems) T1
Agvet chemical: napropamide
Permitted residue: napropamideAll other foods except animal food commodities
0.02
Agvet chemical: novaluron
Permitted residue: novaluron
Brassica (cole or cabbage) vegetables, head cabbages, flowerhead brassicas
0.3
Fruiting vegetables, other than cucurbits 0.2Leafy vegetables 5
Agvet chemical: permethrin
Permitted residue: permethrin, sum of isomersPoppy seed T0.2
Agvet chemical: prothioconazole
Permitted residue—commodities of plant origin: sum of prothioconazole and prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazolePermitted residue—commodities of animal origin: sum of prothioconazole, prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-3-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol) and prothioconazole-4-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-4-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazoleWatermelon T0.2
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Agvet chemical: pyridate
Permitted residue: sum of pyridate and metabolites containing 6 chloro-4-hydroxyl-3-phenyl pyridazine, expressed as pyridate
Chick-pea (dry) *0.05
[1.3] omitting from each of the following chemicals, the foods and associated MRLs
Agvet chemical: indoxacarb
Permitted residue: sum of indoxacarb and its R-isomer
Peppers, sweet [capsicum] 0.5
[1.4] omitting for each of the following chemicals, the maximum residue limit for the food and substituting
Agvet chemical: etoxazole
Permitted residue: etoxazoleAvocado T0.05
Agvet chemical: fludioxonilPermitted residue—commodities of animal origin: sum of fludioxonil and oxidisable metabolites, expressed as fludioxonilPermitted residue—commodities of plant origin: fludioxonilRape seed (canola) T0.2
Agvet chemical: glufosinate and glufosinate-ammoniumPermitted residue: sum of glufosinate-ammonium, N-acetyl glufosinate and 3-[hydroxy(methyl)-phosphinoyl] propionic acid, expressed as glufosinate (free acid)Rape seed (canola) 0.5
Agvet chemical: glyphosate
Permitted residue: sum of glyphosate, N-acetyl-glyphosate and aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosate
Barley 20
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
INVITATION FOR SUBMISSIONS
Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the proposal to vary Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code. Submissions should be strictly confined to relevant matters that the APVMA must consider (such as public health and safety) which are associated with the occurrence of the proposed residues in foods. Comments received outside these grounds will not be considered by the APVMA. Claims made in submissions should be supported wherever possible by referencing or including relevant studies, research findings, trials, surveys etc. Technical information should be in sufficient detail to allow independent scientific assessment.
Please note that FSANZ will make a SPS notification to the WTO and submissions related to impacts on international trade should be made to FSANZ in response to that notification.
Submissions must be made in writing and should be clearly marked as a ‘submission on the proposed amendment to Schedule 20’ and quote the correct amendment number.
DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (AEST) 30 June 2020.
SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL ONLY BE CONSIDERED BY PRIOR ARRANGEMENT
Submissions received after this date will only be considered if agreement for an extension has been given prior to this closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to the submission period.
For further information please contact:
MRL Contact Officer Australian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001
Phone: +61 2 6770 2300Email: [email protected]
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
The APVMA has previously gazetted particular amendments which it had made to the APVMA MRL Standard and which have been proposed as variations to maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in Schedule 20–Maximum Residue Limits of the Australia New Zealand Food Standards Code. This notice pertains to proposal (No. 2) gazetted on 10 March 2020 (No. APVMA 5).
Submissions have been sought on these proposals and the APVMA has written separately to each person or organisation that made a submission. All matters raised in the submissions have been resolved.
Under subsection 82(1) of the Food Standards Australia New Zealand Act 1991, the APVMA has, by legislative instrument, incorporated these variations to MRLs into Schedule 20. A copy of the Amendment Instrument (No. APVMA 4, 2020) accompanies this notice. For a complete and up-to-date version of Schedule 20, including these amendments together with their Explanatory Statement, please refer to the Federal Register of Legislation available on the Legislation website.
Based on dietary exposure assessments and current health standards, the APVMA and Food Standards Australia and New Zealand (FSANZ) are satisfied that these MRLs are not harmful to public health. MRLs contained in Schedule 20 provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this means, Schedule 20 permits the sale of treated foods and protects public health by minimising residues in foods consistent with the effective control of pests and diseases.
The agreement between the Australian Government and the New Zealand Government concerning a Joint Food Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.
Food Standards Australia New Zealand (FSANZ) made Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO) in relation to these variations and no comment was received in response to that notice.
A copy of these variations have been given to FSANZ.
The variations take effect as from the date of this notice.
This notice is published in accordance with subsection 82(7) of the Food Standards Australia New Zealand Act 1991.
For further information please contact:
MRL Contact OfficerAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001
Phone: +61 2 6770 2383Email: [email protected]
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Australia New Zealand Food Standards Code—Schedule 20—Maximum residue limits Variation
Instrument No. APVMA 4, 2020
I, Jason Lutze, delegate of the Australian Pesticides and Veterinary Medicines Authority, acting in accordance with my powers under subsection 11(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992, make this instrument for the purposes of subsection 82(1) of the Food Standards Australia New Zealand Act 1991.
Jason LutzeDelegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority
Dated this Twenty sixth day of May 2020
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Part 1 Preliminary1 Name of instrument
This instrument is the Australia New Zealand Food Standards Code–Schedule 20maximum residue limits Variation Instrument No. APVMA 4, 2020.
2 CommencementIn accordance with subsection 82(8) of the Food Standards Australia New Zealand Act 1991, this instrument commences on the day it is published in the Gazette.
Note: A copy of the variations made by the Amendment Instrument was published in the Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette.
3 ObjectThe object of this instrument is for the APVMA to make variations to Schedule 20Maximum residue limits in the Australia New Zealand Food Standards Code to include or change maximum residue limits pertaining to agricultural and veterinary chemical products.
4 InterpretationIn this instrument:APVMA means the Australian Pesticides and Veterinary Medicines Authority established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; andPrincipal Instrument means Schedule 20Maximum residue limits in the Australia New Zealand Food Standard Code as defined in Section 4 of the Food Standards Australia New Zealand Act 1991 being the Code published in Gazette No. P 27 on 27 August 1987 together with any amendments of the standards in that Code. Schedule 20 was published in the Food Standards Gazette FSC 96 on Thursday 10 April 2015 and was registered as a legislative instrument on 1 April 2015 (F2015L00468).
Part 2 Variations to Schedule 20–Maximum Residue Limits
5 Variations to Schedule 20The Schedule to this instrument sets out the variations made to the Principal Instrument by this instrument.
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Schedule
Variations to Schedule 20–maximum residue limits
[1] The table to section S20–3 in Schedule 20 is varied by
[1.1] inserting in alphabetical order
Agvet chemical: paracetamol
Permitted residue: paracetamolPig fat/skin *0.1Pig kidney *0.1Pig liver *0.1Pig muscle *0.1
[1.2] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order
Agvet chemical: bupirimate
Permitted residue: bupirimate
Tomato T1
Agvet chemical: cyanamide
Permitted residue: cyanamide
Almonds *0.01
Agvet chemical: cyazofamid
Permitted residue: cyazofamidAll other foods except animal food commodities
0.04
Poppy seed T*0.01
Agvet chemical: diafenthiuron
Permitted residue: sum of diafenthiuron; N-[2,6-bis(1-methylethyl)-4-phenoxyphenyl]-N′-(1,1-dimethylethyl)urea; and N-[2,6-bis(1-methylethyl)-4-phenoxyphenyl]- N′-(1,1-dimethylethyl)carbodiimide, expressed as diafenthiuron
Peanut T0.3Soya bean (dry) T0.3
Agvet chemical: fludioxonil
Permitted residue: commodities of animal origin: Sum of fludioxonil and oxidisable metabolites, expressed as fludioxonilPermitted residue—commodities of plant origin: fludioxonilPapaya T5
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Agvet chemical: fluopicolide
Permitted residue: fluopicolide
Basil T30
Agvet chemical: indoxacarb
Permitted residue: sum of indoxacarb and its R-isomer
Walnuts T0.02
Agvet chemical: metolachlor
Permitted residue: metolachlorPulses [except soya beans (dry); adzuki beans (dry)]
*0.01
Agvet chemical: propamocarb
Permitted residue: propamocarb (base)Basil T150
[1.3] omitting for each of the following chemicals, the maximum residue limit for the food and substituting
Agvet chemical: cyanamide
Permitted residue: cyanamide
Walnuts *0.02
Agvet chemical: fluopicolide
Permitted residue: fluopicolideBrassica (cole or cabage) vegetables, head cabbages, flowerhead brassicas
5
Agvet chemical: linuron
Permitted residue: permitted residue: sum of linuron plus 3,4-dichloroaniline, expressed as linuron
Celeriac T3
Agvet chemical: metolachlor
Permitted residue: metolachlor
Mung bean (dry) T*0.05Pulses [except adzuki bean (dry); mung bean (dry); soya bean (dry)]
*0.01
Agvet chemical: propamocarb
Permitted residue: propamocarb (base)Leafy vegetables 70
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
Notice of cancellation at the request of the holder
At the request of the holder, in accordance with section 42(1) of the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code), the Australian Pesticides and Veterinary Medicines Authority (APVMA) has cancelled the approvals and/or registrations set out in the table below.
Approval or registration N=number
Name Type of approval or registration
Holder Date of cancellation
44220 Phenylmercury acetate manufacturing concentrate
Active constituent Alpha Chemicals Pty Ltd
26 May 2020
44221 Methoxyethylmercuric acetate manufacturing concentrate
Active constituent Alpha Chemicals Pty Ltd
26 May 2020
44222 Methoxyethylmercuric chloride manufacturing concentrate
Active constituent Alpha Chemicals Pty Ltd
26 May 2020
44223 Methoxyethylmercuric chloride manufacturing concentrate
Active constituent Alpha Chemicals Pty Ltd
26 May 2020
In accordance with section 45A(1)(b) of the Agvet Code, the APVMA publishes this notice of the cancellation, including the following reasons, instructions, and warnings which set out how a person can deal with the cancelled active constituent, cancelled product or product bearing a cancelled label referred to in the above table.
BRIEF REASONS
Pursuant to section 42(1)(b) of the Agvet Code, the APVMA was satisfied that there are no valid reasons why the APVMA should not agree to the request of the holder to cancel the approvals and/or registrations set out in the above table.
INSTRUCTIONS FOR PERSONS WHO POSSESS, HAVE CUSTODY OF OR USE THE CANCELLED ACTIVE CONSTITUENT, CANCELLED PRODUCT, OR THE PRODUCT BEARING A CANCELLED LABEL UNDER SECTION 45A(2)OF THE AGVET CODE
A person who possesses, has custody of or uses the cancelled active constituent, cancelled product or product bearing a cancelled label referred to in the above table in accordance with the instructions contained in this notice, is taken to have been issued with a permit under section 45B(3) of the Agvet Code to possess, have custody of or use the cancelled active constituent, cancelled product or product bearing a cancelled label, in accordance with those instructions.
POSSESSION OR CUSTODY
A person may possess the cancelled active constituent, cancelled product or product bearing a cancelled label referred to in the above table in accordance with its label instructions for 12 months from the date of cancellation.
Notice of cancellation at the request of the holder
Commonwealth of Australia GazetteNo. APVMA 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994
USE, SUPPLY OR OTHERWISE DEAL WITH
A person may use the cancelled active constituent, cancelled product or products bearing a cancelled label referred to in the above table according to its label instructions, including any conditions relating to shelf life or expiry date, for 12 months after the date of cancellation.
A person may supply or cause to be supplied at wholesale or retail level the cancelled active constituent, cancelled product, or product bearing a cancelled label referred to in the above table, for 12 months after the date of cancellation.
WARNING - CONTRAVENTIONS
After the day that is 12 months from the date of cancellation it will be an offence against the Agvet Code to have possession or custody of the cancelled active constituents, cancelled products or products bearing a cancelled label with the intention to supply, or to supply the cancelled active constituent, cancelled product, or product bearing a cancelled label.
It is an offence to possess, have custody of, use, or otherwise deal with the cancelled active constituents, cancelled products or products bearing the cancelled label listed in the table above in a manner that contravenes the above instructions.
APVMA CONTACT
For any enquiries or further information about this matter, please contact:
Chemical ReviewAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001
Phone: +61 2 6770 2400
Email: [email protected]
Notice of cancellation at the request of the holder