Gazette Agricultural and
Veterinary Chemicals
No. APVMA 24, Tuesday, 1 December 2020
Published by the Australian Pesticides and Veterinary Medicines Authority
The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The
Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be
published in the Gazette containing details of the registration of agricultural and veterinary chemical products
and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code
and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet
Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.
ISSN 1837-7629
© Commonwealth of Australia 2020
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any
process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and
inquiries concerning reproduction and rights should be addressed to:
Assistant Director, Communications
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Email: [email protected]
Website: apvma.gov.au
GENERAL INFORMATION
The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of
the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as requi red
by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material
issued by the APVMA.
Pursuant to section 8J(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications
made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in
quarterly statistical reports.
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Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Agricultural Chemical Products and Approved Labels ..................................................................................................... 4
Veterinary Chemical Products and Approved Labels .................................................................................................... 14
Approved Active Constituents ....................................................................................................................................... 17
New Agricultural Active Constituent: Acequinocyl ......................................................................................................... 19
Amendments to the APVMA MRL Standard .................................................................................................................. 21
Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code ................................................. 22
Variations to Schedule 20 of the Australia New Zealand Food Standards Code ........................................................... 27
Stop Supply: Fleamail Pty Ltd (ACN 637 942 128)........................................................................................................ 32
Stop Supply: Ausrichter Pty Ltd (ACN 000 908 529) ..................................................................................................... 34
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 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.: 124765
Product name: HL Clethodim 240 Herbicide
Active constituent/s: 240 g/L clethodim
Applicant name: Hebei Lansheng Biotech Co Ltd
Applicant ACN: N/A
Summary of use: For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas, cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, lettuce, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans
Date of registration: 3 July 2020
Product registration no.: 89416
Label approval no.: 89416/124765
Application no.: 120808
Product name: Yates Grub Kill & Protect For Lawns C Up To 6 Months Protection Against Curl Grub
Active constituent/s: 200 g/L chlorantraniliprole
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of use: For the control of lawn grubs in the home garden
Date of registration: 10 July 2020
Product registration no.: 88297
Label approval no.: 88297/120808
Application no.: 122563
Product name: Searles Dead Grub Pro Hose-On For Lawns
Active constituent/s: 4.8 g/L bifenthrin
Applicant name: J.C. & A.T. Searle Pty Ltd
Applicant ACN: 002 898 893
Summary of use: To control lawn beetles and lawn grubs in the home garden
Date of registration: 13 August 2020
Product registration no.: 88821
Label approval no.: 88821/122563
Application no.: 127160
Product name: eChem e-Strobin 250 SC Fungicide
Active constituent/s: 250 g/L azoxystrobin
Applicant name: eChem (Australia) Pty Ltd
Applicant ACN: 089 133 095
Summary of use: For the control of various diseases of grapes, potatoes, tomatoes, cucurbits, avocados, mangoes, passionfruit and poppies
Date of registration: 28 October 2020
Product registration no.: 90038
Label approval no.: 90038/127160
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 5
Agricultural Chemical Products and Approved Labels
Application no.: 123025
Product name: Nufarm Amishield 500WG Fungicide
Active constituent/s: 500 g/kg amisulbrom
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of use: For control of clubroot and suppression of damping off in brassicas and the control of powdery scab and suppression of pink rot in potatoes
Date of registration: 9 November 2020
Product registration no.: 88958
Label approval no.: 88958/123025
Application no.: 127302
Product name: Retacel 720 Plant Growth Regulant
Active constituent/s: 558 g/L chlormequat present as chlormequat chloride
Applicant name: Draslovka Services Pty Ltd
Applicant ACN: 609 536 763
Summary of use: For use as an aid in increasing grain yield and prevention of lodging in wheat
Date of registration: 11 November 2020
Product registration no.: 90074
Label approval no.: 90074/127302
Application no.: 123588
Product name: Coromandel Fipronil 800 WG Insecticide
Active constituent/s: 800 g/kg fipronil
Applicant name: Sabero Australia Pty Ltd
Applicant ACN: 087 313 059
Summary of use: For the control of various insect pests in bananas, brassicas, cotton, wine grapes, mushrooms, pasture, potatoes, sorghum and sugarcane
Date of registration: 11 November 2020
Product registration no.: 89099
Label approval no.: 89099/123588
Application no.: 127313
Product name: eChem e-Grex Selective Herbicide
Active constituent/s: 250 g/L MCPA present as the ethyl hexyl ester, 25 g/L diflufenican
Applicant name: Echem (Aust) Pty Ltd
Applicant ACN: 089 133 095
Summary of use: For the control of certain broadleaf weeds in winter cereals and clover
Date of registration: 12 November 2020
Product registration no.: 90077
Label approval no.: 90077/127313
Application no.: 122770
Product name: JURA Herbicide
Active constituent/s: 667 g/L prosulfocarb, 14 g/L diflufenican
Applicant name: Globachem N.V.
Applicant ACN: N/A
Summary of use: For control of annual rye grass in wheat and barley
Date of registration: 12 November 2020
Product registration no.: 88895
Label approval no.: 88895/122770
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 6
Agricultural Chemical Products and Approved Labels
Application no.: 127314
Product name: eChem Lambda 250 CS Insecticide
Active constituent/s: 250 g/L lambda-cyhalothrin
Applicant name: eChem (Aust) Pty Ltd
Applicant ACN: 089 133 095
Summary of use: For the control of certain insect pests in cotton, barley, wheat and various field crops
Date of registration: 12 November 2020
Product registration no.: 90078
Label approval no.: 90078/127314
Application no.: 124958
Product name: Wynsate PRO 480 DMA Herbicide
Active constituent/s: 480 g/L glyphosate present as the dimethylammonium salt
Applicant name: Zhejiang Xinan Chemical Industrial Group Co Ltd
Applicant ACN: N/A
Summary of use: For non-selective control of many annual and perennial weeds in conservation tillage, pre - and post-harvest uses, agricultural and non-agricultural situations
Date of registration: 13 November 2020
Product registration no.: 89462
Label approval no.: 89462/124958
Application no.: 122013
Product name: Protim Optimum PTB Concentrate
Active constituent/s: 180 g/L tebuconazole, 180 g/L propiconazole, 34 g/L bifenthrin
Applicant name: Koppers Performance Chemicals Australia Pty Ltd
Applicant ACN: 088 260 575
Summary of use: For the protection of softwood and hardwood timber in hazard level H3 (outside and above ground) situations
Date of registration: 13 November 2020
Product registration no.: 88698
Label approval no.: 88698/122013
Application no.: 127104
Product name: Hemani Jolt 800 EC Herbicide
Active constituent/s: 800 g/L prosulfocarb
Applicant name: Hemani Industries Limited
Applicant ACN: N/A
Summary of use: For the control of annual ryegrass (Lolium rigidum) and other grass and broadleaf weeds in barley and wheat
Date of registration: 17 November 2020
Product registration no.: 90031
Label approval no.: 90031/127104
Application no.: 127338
Product name: Sinon Pardnar 600 Herbicide
Active constituent/s: 600 g/kg metsulfuron-methyl
Applicant name: Sinon Australia Pty Ltd
Applicant ACN: 102 741 024
Summary of use: For the control of brush and broadleaf weeds in native pastures, rights of way, commercial and industrial areas, for the control of certain broadleaf weeds in winter cereal crops and for pre-harvest desiccation in mung beans
Date of registration: 19 November 2020
Product registration no.: 90086
Label approval no.: 90086/127338
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 7
Agricultural Chemical Products and Approved Labels
2. VARIATIONS OF REGISTRATION
Application no.: 126307
Product name: Rainbow Glufosinate 200 Herbicide
Active constituent/s: 200 g/L glufosinate-ammonium
Applicant name: Shandong Rainbow International Co Ltd
Applicant ACN: N/A
Summary of variation: To add uses in turf, summer fallow situations (cereal grains, pulses and oilseeds), commercial and industrial areas, forest plantations, rights-of-way and other non-agricultural areas
Date of variation: 8 October 2020
Product registration no.: 66593
Label approval no.: 66593/126307
Application no.: 128437
Product name: Kermit Bio 360 Herbicide
Active constituent/s: 360 g/L glyphosate present as the isopropylamine salt
Applicant name: Crop Culture Pty Ltd
Applicant ACN: 142 860 473
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Kermit 360 Herbicide’ to ‘Kermit Bio 360 Herbicide’
Date of variation: 26 October 2020
Product registration no.: 63601
Label approval no.: 63601/128437
Application no.: 128424
Product name: Kermit Bio 510 Herbicide
Active constituent/s: 510 g/L glyphosate present as the isopropylamine salt
Applicant name: Crop Culture Pty Ltd
Applicant ACN: 142 860 473
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Kermit 510 Herbicide’ to ‘Kermit Bio 510 Herbicide’
Date of variation: 26 October 2020
Product registration no.: 64370
Label approval no.: 64370/128424
Application no.: 127111
Product name: Accensi Oryzalin 500 Herbicide
Active constituent/s: 500 g/L oryzalin
Applicant name: Accensi Pty Ltd
Applicant ACN: 079 875 184
Summary of variation: To add use against broadleaf and grass weeds in ginger and duboisia
Date of variation: 28 October 2020
Product registration no.: 66403
Label approval no.: 66403/127111
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 8
Agricultural Chemical Products and Approved Labels
Application no.: 128499
Product name: Pooled Energy Bromide Up
Active constituent/s: 995 g/kg sodium bromide
Applicant name: Pooled Energy Pty Ltd
Applicant ACN: 163 873 078
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Pooled Energy Pool Sanitizer Precursor’ to ‘Pooled Energy Bromide Up’
Date of variation: 28 October 2020
Product registration no.: 87474
Label approval no.: 87474/128499
Application no.: 128519
Product name: ProGuard Granular Pool Sanitiser
Active constituent/s: 660 g/kg chlorine present as trichloroisocyanuric acid
Applicant name: Biolab Australia Pty Ltd
Applicant ACN: 005 878 017
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Proguard Trichlor Plus Granules Pool Sanitiser’ to ‘Proguard Granular Pool Sanitiser’
Date of variation: 30 October 2020
Product registration no.: 66471
Label approval no.: 66471/128519
Application no.: 128594
Product name: Barmac Trifluralin 480 Herbicide
Active constituent/s: 480 g/L trifluralin
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 ‘Barmac Tri-Max 480 Herbicide’ to ‘Barmac Trifluralin 480 Herbicide’
Date of variation: 6 November 2020
Product registration no.: 88601
Label approval no.: 88601/128594
Application no.: 121545
Product name: Skope Insecticide
Active constituent/s: 218 g/L acetamiprid, 32.5 g/L emamectin present as emamectin benzoate
Applicant name: ADAMA Australia Pty Ltd
Applicant ACN: 050 328 973
Summary of variation: To extend use to include control of various pests in pulses and control of jassids and two-spotted mite in cotton
Date of variation: 9 November 2020
Product registration no.: 81486
Label approval no.: 81486/121545
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 9
Agricultural Chemical Products and Approved Labels
Application no.: 127198
Product name: Accensi Metolachlor 960 Herbicide
Active constituent/s: 960 g/L metolachlor
Applicant name: Accensi Pty Ltd
Applicant ACN: 079 875 184
Summary of variation: To add the instructions for multiple pests in mustard, various broadleaf and grass weeds in spinach, silverbeet, spring onions, shallots, green beans and navy beans and certain annual grasses and broadleaf weeds in adzuki beans and mung beans
Date of variation: 9 November 2020
Product registration no.: 67083
Label approval no.: 67083/127198
Application no.: 126643
Product name: Family Protection Aerogard Body Odourless Protection 6 Hours Protection Low Irritant* Great For Kids 12 Months+ Insect Repellent Spray
Active constituent/s: 92.8 g/L picaridin
Applicant name: RB (Hygiene Home) Australia Pty Ltd
Applicant ACN: 629 549 506
Summary of variation: To change product name, expand registered pack sizes, add additional manufacturing sites and amend approved label
Date of variation: 9 November 2020
Product registration no.: 61365
Label approval no.: 61365/126643
Application no.: 125824
Product name: Oskar 540 Herbicide
Active constituent/s: 540 g/L glyphosate present as the potassium salt
Applicant name: Crop Culture Pty Ltd
Applicant ACN: 142 860 473
Summary of variation: To add additional situations including control of various weeds in pasture
Date of variation: 10 November 2020
Product registration no.: 85145
Label approval no.: 85145/125824
Application no.: 127275
Product name: Imtrade Simazine 900 WG Herbicide
Active constituent/s: 900 g/kg simazine
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of variation: To add the following uses under the Permit to Label Project: broadleaf weeds and grasses in almonds, various pests in pyrethrum crops, weed control in walnuts, specified grass and broadleaf weeds in leeks, various pests and diseases in tea tree oil, broadleaf and grass weeds in ginger (Zingiber officinale), weed and sucker control in hazel nuts, various weeds in nursery stock (non-food), foliage, cut flowers and wildflowers
Date of variation: 10 November 2020
Product registration no.: 63660
Label approval no.: 63660/127275
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 10
Agricultural Chemical Products and Approved Labels
Application no.: 127180
Product name: Chemag Thor 250EC Herbicide
Active constituent/s: 125 g/L oryzalin, 125 g/L trifluralin
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of variation: To add a use for the control of weeds in mustard
Date of variation: 11 November 2020
Product registration no.: 60141
Label approval no.: 60141/127180
Application no.: 127107
Product name: Trelona Termite Bait
Active constituent/s: 5 g/kg novaluron
Applicant name: BASF Australia Ltd
Applicant ACN: 008 437 867
Summary of variation: To include use in above ground baiting stations for the control of subterranean termites and the protection of structures
Date of variation: 11 November 2020
Product registration no.: 86731
Label approval no.: 86731/127107
Application no.: 127298
Product name: Imtrade Tebuconazole 430 SC Fungicide
Active constituent/s: 430 g/L tebuconazole
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of variation: To add the following use instructions: duboisia, anise myrtle, lemon myrtle, oil tea tree, beetroot, beetroot leaves, carrots, chicory, endive, radish, silverbeet, spinach, mung beans, faba beans, broad beans, soya beans, garlic, walnuts and non-food producing plants including nursery stock
Date of variation: 11 November 2020
Product registration no.: 63454
Label approval no.: 63454/127298
Application no.: 126672
Product name: Nufarm Avadex Xtra Selective Herbicide
Active constituent/s: 500 g/L triallate
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of variation: To add a new use in wheat and to add uses under the Permit to Label Project
Date of variation: 12 November 2020
Product registration no.: 56598
Label approval no.: 56598/126672
Application no.: 126178
Product name: Timbertreat A Azole Insecticide/Fungicide Wood Preservative
Active constituent/s: 125 g/L propiconazole, 125 g/L tebuconazole, 83 g/L permethrin
Applicant name: Kop-Coat Australia Pty Ltd
Applicant ACN: 088 537 473
Summary of variation: To add uses for the treatment of eucalyptus nitens timber decking using a spray flood coating system
Date of variation: 13 November 2020
Product registration no.: 69683
Label approval no.: 69683/126178
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 11
Agricultural Chemical Products and Approved Labels
Application no.: 125914
Product name: Conquest Tricon Flexi 480 Selective Herbicide
Active constituent/s: 480 g/L trifluralin
Applicant name: Conquest Crop Protection Pty Ltd
Applicant ACN: 098 814 932
Summary of variation: To add uses in legumes, oilseeds, peppers and eggplant, quinoa, parsnips, swede, turnip, duboisia and industrial hemp
Date of variation: 17 November 2020
Product registration no.: 60603
Label approval no.: 60603/125914
Application no.: 127205
Product name: Conquest Triagra 500 EC Selective Herbicide
Active constituent/s: 500 g/L triallate
Applicant name: Conquest Crop Protection Pty Ltd
Applicant ACN: 098 814 932
Summary of variation: To add new uses for control of grasses and broadleaf weeds in wheat, barley, triticale and canola
Date of variation: 17 November 2020
Product registration no.: 65419
Label approval no.: 65419/127205
Application no.: 126181
Product name: Biotrap DDVP Cubes
Active constituent/s: 186 g/kg dichlorvos (an anticholinesterase compound)
Applicant name: Bio-trap Australia Pty Ltd
Applicant ACN: 127 689 507
Summary of variation: To extend the use of the product to monitor/control insects more broadly in commercial orchards and other horticultural crops
Date of variation: 18 November 2020
Product registration no.: 68989
Label approval no.: 68989/126181
Application no.: 127271
Product name: Apparent Expunge 600 FS Insecticide
Active constituent/s: 600 g/L imidacloprid
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of variation: To amend the formulation type of the product and update the product name to ‘Apparent Expunge 600 FS Insecticide’
Date of variation: 18 November 2020
Product registration no.: 68402
Label approval no.: 68402/127271
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 12
Agricultural Chemical Products and Approved Labels
Application no.: 127394
Product name: Imtrade Metal Gold 960 EC Herbicide
Active constituent/s: 960 g/L S-Metolachlor
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of variation: To add the control of various weeds in rhubarb, various broadleaf and grass weeds in brassica leafy vegetables, multiple pests in mustard, various broadleaf and grass weeds in spinach, silverbeet, spring onions, shallots, green beans and navy beans and various weeds in culinary herbs
Date of variation: 18 November 2020
Product registration no.: 69336
Label approval no.: 69336/127394
Application no.: 126557
Product name: Agri-Fos 600 Systemic Fungicide
Active constituent/s: 600 g/L phosphorous (phosphonic) acid as mono-di k phosphonate
Applicant name: Liquid Fertiliser Pty Ltd
Applicant ACN: 105 456 148
Summary of variation: To shorten the withholding period for macadamias from 28 days to 14 days
Date of variation: 18 November 2020
Product registration no.: 54430
Label approval no.: 54430/126557
Application no.: 127320
Product name: Amgrow Chemspray Weed Control Tree & Blackberry Killer
Active constituent/s: 50 g/L triclopyr present as the butoxyethyl ester
Applicant name: Amgrow Pty Ltd
Applicant ACN: 100 684 786
Summary of variation: To include additional pack sizes
Date of variation: 19 November 2020
Product registration no.: 59002
Label approval no.: 59002/127320
Application no.: 127395
Product name: Imtrade Metal Plus 960 EC Herbicide
Active constituent/s: 960 g/L metolachlor
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of variation: To add uses for multiple pests in mustard, various broadleaf and grass weeds in spinach, silverbeet, spring onions, shallots, green beans and navy beans, certain annual grasses and broadleaf weeds in adzuki beans and mung beans
Date of variation: 20 November 2020
Product registration no.: 66486
Label approval no.: 66486/127395
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 13
Agricultural Chemical Products and Approved Labels
Application no.: 127418
Product name: Surefire Tusk Fungicide
Active constituent/s: 430 g/L tebuconazole
Applicant name: PCT Holdings Pty Ltd
Applicant ACN: 099 023 962
Summary of variation: To add uses in duboisia, oil tea tree, anise myrtle, lemon myrtle, non-food producing plants and vegetation, beetroot, beetroot leaves, chicory, endive, radish, silverbeet, spinach, carrots, mung beans, faba beans, broad beans, soya beans, walnuts and garlic
Date of variation: 20 November 2020
Product registration no.: 84325
Label approval no.: 84325/127418
Application no.: 127399
Product name: Sinker Fungicide
Active constituent/s: 500 g/L flutriafol
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of variation: To update first aid instructions and storage and disposal directions
Date of variation: 20 November 2020
Product registration no.: 67732
Label approval no.: 67732/127399
3. VARIATION OF LABEL APPROVAL
Application no.: 127170
Product name: Chippolay Selective Herbicide
Active constituent/s: 700 g/kg methabenzthiazuron
Applicant name: Agnova Technologies Pty Ltd
Applicant ACN: 097 705 158
Summary of variation: To delete a maximum rate on the product label and add a recommendation to tank mix
Date of variation: 17 November 2020
Product registration no.: 86507
Label approval no.: 86507/127170
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 14
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 EXISTING ACTIVE CONSTITUENTS
Application no.: 125868
Product name: Cura-Linc 790 g/kg Antibiotic Soluble Powder
Active constituent/s: 1,000 g/kg lincomycin hydrochloride equivalent to not less than 790 g/kg lincomycin base
Applicant name: Probus Pharmaceuticals Pty Ltd
Applicant ACN: 638 193 674
Summary of use: For treatment of swine dysentery caused by Serpulina hyodysenteriae in pigs
Date of registration: 11 November 2020
Product registration no.: 89713
Label approval no.: 89713/125868
Application no.: 125896
Product name: Di-Fly Extra Spray-On Blowfly Treatment For Sheep
Active constituent/s: 65 g/L dicyclanil
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of use: For the protection of sheep against fly strike and the protection of mulesing and marking wounds on sheep against fly strike during the wound healing process
Date of registration: 13 November 2020
Product registration no.: 89723
Label approval no.: 89723/125896
Application no.: 107550
Product name: Vanguard Intranasal Resp 3 Live Vaccine For Dogs
Active constituent/s: Each dose contains live attenuated: Canine Adenovirus Type 2 (≥10^3.1 TCID50), Canine Parainfluenza Virus (≥10^5.0 TCID50), Bordetella bronchiseptica (≥1.3 x 10^6 CFU)
Applicant name: Zoetis Australia Pty Ltd
Applicant ACN: 156 476 425
Summary of use: For the active immunisation of healthy dogs and puppies from 8 weeks of age to reduce clinical signs associated with respiratory tract disease and shedding induced by Bordetella bronchiseptica, Canine Parainfluenza Virus (CPI) and Canine Adenovirus Type 2 (CAV-2)
Date of registration: 13 November 2020
Product registration no.: 83109
Label approval no.: 83109/107550
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 15
Veterinary Chemical Products and Approved Labels
Application no.: 126018
Product name: Kefvet Oral Antibiotic Drops For Dogs And Cats
Active constituent/s: 150 mg/g cephalexin
Applicant name: Bocko P/L & Flexsky P/L In Partnership
Applicant ABN: 57 147 389 678
Summary of use: For treatment of susceptible infections of the respiratory tract, urogenital tract, the skin and localised infections in soft tissues of dogs and cats
Date of registration: 13 November 2020
Product registration no.: 89760
Label approval no.: 89760/126018
2. VARIATIONS OF REGISTRATION
Application no.: 128488
Product name: ZeroMec Premix For Pigs
Active constituent/s: 6 g/kg ivermectin
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘I-Mec Premix For Pigs’ to ‘ZeroMec Premix For Pigs’
Date of variation: 28 October 2020
Product registration no.: 87145
Label approval no.: 87145 / 128488
Application no: 126120
Product name: Equine Joint Support Formula 2
Active constituent/s: 200 g/kg glucosamine sulphate (marine exoskeleton), 60 g/kg sodium chondroitin sulphate (bovine cartilage)
Applicant name: International Animal Health Products Pty Ltd
Applicant ACN: 003 185 699
Summary of variation: To vary the claim statement and to add 2 pack sizes
Date of variation: 10 November 2020
Product registration no.: 64740
Label approval no.: 64740/126120
Application no: 127060
Product name: Milbemax Tablets for Small Cats
Active constituent/s: 10 mg/tb praziquantel, 4 mg/tb milbemycin oxime
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation: To update the wording of the approved label
Date of variation: 11 November 2020
Product registration no.: 54264
Label approval no.: 54264/127060
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 16
Veterinary Chemical Products and Approved Labels
Application no.: 127061
Product name: Milbemax Tablets for Cats
Active constituent/s: 40 mg/tb praziquantel, 16 mg/tb milbemycin oxime
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation: To update the wording of the approved label
Date of variation: 11 November 2020
Product registration no.: 54265
Label approval no.: 54265/127061
Application no.: 125961
Product name: Clomav 80mg Tablets
Active constituent/s: 80 mg/tb clomipramine hydrochloride equivalent to 72 mg clomipramine
Applicant name: Mavlab Pty Ltd
Applicant ACN: 009 708 187
Summary of variation: To add 2 additional pack sizes
Date of variation: 16 November 2020
Product registration no.: 63990
Label approval no.: 63990/125961
Application no.: 125962
Product name: Clomav 20mg Tablets
Active constituent/s: 20 mg/tb clomipramine hydrochloride equivalent to 18 mg clomipramine
Applicant name: Mavlab Pty Ltd
Applicant ACN: 009 708 187
Summary of variation: To add 2 additional pack sizes
Date of variation: 16 November 2020
Product registration no.: 63991
Label approval no.: 63991/125962
Application no.: 125963
Product name: Clomav 5mg Tablets
Active constituent/s: 5 mg/tb clomipramine hydrochloride equivalent to 4.5 mg clomipramine
Applicant name: Mavlab Pty Ltd
Applicant ACN: 009 708 187
Summary of variation: To add 2 additional pack sizes
Date of variation: 16 November 2020
Product registration no.: 63992
Label approval no.: 63992/125963
Application no: 127341
Product name: Troy Behave Equine – Tryptophan and Vitamin Supplement Paste
Active constituent/s: 333 mg/mL L-tryptophan
Applicant name: Troy Laboratories Pty Ltd
Applicant ACN: 000 283 769
Summary of variation: To add a new pack size
Date of variation: 18 November 2020
Product registration no.: 62502
Label approval no.: 62502/127341
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 17
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.: 124939
Active constituent/s: Clothianidin
Applicant name: BASF Australia Ltd
Applicant ACN: 008 437 867
Summary of use: For use in agricultural chemical products
Date of approval: 10 November 2020
Approval no.: 89452
Application no.: 124785
Active constituent/s: Clothianidin
Applicant name: BASF Australia Ltd
Applicant ACN: 008 437 867
Summary of use: For use in agricultural chemical products
Date of approval: 10 November 2020
Approval no.: 89418
Application no.: 123631
Active constituent/s: 2,4-D 2-ethylhexyl ester
Applicant name: Kenso Corporation (M) Sdn Bhd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 11 November 2020
Approval no.: 89105
Application no.: 123077
Active constituent/s: 2,4-D isobutyl ester
Applicant name: 4 Farmers Australia Pty Ltd
Applicant ACN: 160 092 428
Summary of use: For use in agricultural chemical products
Date of approval: 12 November 2020
Approval no.: 88976
Application no.: 126036
Active constituent/s: Maropitant citrate
Applicant name: Zoetis Australia Ltd
Applicant ACN: 156 476 425
Summary of use: For use in veterinary chemical products
Date of approval: 13 November 2020
Approval no.: 89769
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 18
Approved Active Constituents
Application no.: 123193
Active constituent/s: 2,4-D-2-ethylhexyl ester
Applicant name: Niensis Pty Ltd
Applicant ACN: 633 476 892
Summary of use: For use in agricultural chemical products
Date of approval: 13 November 2020
Approval no.: 89021
Application no.: 107559
Active constituent/s: Bordetella bronshiseptica
Applicant name: Zoetis Australia Pty Ltd
Applicant ACN: 156 476 425
Summary of use: For use in veterinary chemical products
Date of approval: 13 November 2020
Approval no.: 83114
Application no.: 125093
Active constituent/s: Fluazifop-P-butyl
Applicant name: Shandong Binnong Technology Co Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 18 November 2020
Approval no.: 89506
Application no.: 125134
Active constituent/s: Abamectin
Applicant name: Shanghai E-Tong Chemical Co Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 18 November 2020
Approval no.: 89524
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 19
New Agricultural Active Constituent: Acequinocyl
New Agricultural Active Constituent: Acequinocyl
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a
new active constituent, acequinocyl, for use in the control of all immature life stages of spider mites in greenhouses and
shade houses on container-grown ornamental, floral, foliage and nursery crops as well as on field-grown ornamentals
and pome fruit using ground application equipment.
PARTICULARS OF THE ACTIVE CONSTITUENT
Common name: Acequinocyl
IUPAC name: 3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate
CAS name: 2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione
CAS registry number: 57960-19-7
Minimum purity: 960 g/kg
Molecular formula: C24H32O4
Molecular weight: 384.5 gmol-1
Structure:
Chemical family: 1,4-naphthoquinone
SUMMARY OF THE APVMA’S EVALUATION OF ACEQUINOCYL ACTIVE CONSTITUENT
The APVMA has evaluated the chemistry aspects of active constituent acequinocyl (physico-chemical properties,
identification, spectra, manufacturing process, quality control procedures, batch analysis results and analytical methods)
and found them to be acceptable.
The APVMA has considered the toxicological aspects of acequinocyl, and concluded that there are no toxicological
concerns regarding the approval of this active constituent. An acceptable daily intake (ADI) for acequinocyl was
established at 0.023 mg/kg bw/day, while an acute reference dose (ARfD) was established at 0.08 mg/kg bw. No
toxicologically significant impurities have been identified in acequinocyl technical active constituent.
The Scheduling Delegate made a final decision to included acequinocyl in Schedule 5 of the SUSMP with no cut-off or
exemption, and with effect from 1 June 2020.
On the basis of the data provided, and the toxicological assessment, it is proposed that the following active constituent
standard be established for acequinocyl:
Constituent Level
Acequinocyl Minimum purity 960 g/kg
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 20
New Agricultural Active Constituent: Acequinocyl
Other compounds of toxicological significance are not expected to occur in acequinocyl as a result of the raw materials
and the synthetic route used.
The APVMA is satisfied that the proposed importation and use of acequinocyl would not be an undue toxicological
hazard to the safety of people exposed to it during its handling and use.
FURTHER INFORMATION
A Public Release Summary (PRS) of the evaluations of the active and the associated product is available from the APVMA
website’s ‘Public Consultation’ page.
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 acequinocyl 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.
Please note: Submissions will be published on the APVMA’s website, unless you have asked for the submission to
remain confidential (see public submission coversheet).
Please lodge your submission with a public submission coversheet, which provides options for how your submission will
be published.
Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may
be required to be released under that Act should a request for access be made.
Please send your written submission and coversheet by email or post to:
Email: [email protected]
Post:
Director of Chemistry and Manufacture
Risk Assessment Capability
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
https://apvma.gov.au/news-and-publications/public-consultationshttps://apvma.gov.au/node/72856https://apvma.gov.au/node/72856mailto:[email protected]
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 21
Amendments to the APVMA MRL Standard
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. 10) 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 Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2401
Email: [email protected]
https://www.legislation.gov.au/Series/F2019L01105mailto:[email protected]
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 22
Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code
Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code
In the previous notice on page 21 of APVMA Gazette No. 24, 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. 10) 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.
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 23
Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code
PROPOSED VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE
(1 December 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] omitting from each of the following chemicals, the foods and associated MRLs
Agvet chemical: acetamiprid
Permitted residue – commodities of plant origin: acetamiprid
Permitted residue – commodities of animal origin: sum of acetamiprid and N-demethyl acetamiprid ((E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyanoacetamidine), expressed as acetamiprid
Avocado 0.05
Mango 0.05
Agvet chemical: cyproconazole
Permitted residue – cyproconazole, sum of isomers
Chick-pea (dry) 0.03
Lentil (dry) 0.03
Agvet chemical: pyriproxyfen
Permitted residue – pyriproxyfen
Avocado 0.05
Mango 0.05
Olives 1
[1.2] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order
Agvet chemical: acetamiprid
Permitted residue – commodities of plant origin: acetamiprid
Permitted residue – commodities of animal origin: sum of acetamiprid and N-demethyl acetamiprid ((E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyanoacetamidine), expressed as acetamiprid
Assorted tropical and sub-tropical fruits – inedible peel
0.2
Olives for oil production T0.5
Persimmon, Japanese T0.3
Table olives T0.5
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 24
Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code
Agvet chemical: afidopyropen
Permitted residue – commodities of plant origin: afidopyropen
Permitted residue – commodities of animal origin: afidopyropen and the carnitine conjugate of cyclopropanecarboxylic acid (M440I060), expressed as afidopyropen
Artichoke, globe 0.1
Barley *0.01
Rape seed [canola] *0.01
Rhubarb 0.1
Sweet corn (corn-on-the-cob) *0.01
Wheat *0.01
Agvet chemical: cyproconazole
Permitted residue – cyproconazole, sum of isomers
Pulses 0.05
Sweet corn (corn-on-the-cob) *0.01
Agvet chemical: flumioxazin
Permitted residue – flumioxazin
Banana T*0.02
Agvet chemical: pyriproxyfen
Permitted residue – pyriproxyfen
Assorted tropical and sub-tropical fruits – inedible peel
0.3
Olives for oil production 1
Persimmon, Japanese T0.2
Table olives 1
Agvet chemical: tetraniliprole
Permitted residue – tetraniliprole
All other foods except animal commodities
0.02
Mango T0.2
Meat (mammalian) *0.01
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 25
Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code
[1.3] omitting for each of the following chemicals, the maximum residue limit for the food and substituting
Agvet chemical: afidopyropen
Permitted residue – commodities of plant origin: Afidopyropen
Permitted residue – commodities of animal origin: Afidopyropen and the carnitine conjugate of cyclopropanecarboxylic acid (M440I060), expressed as afidopyropen
Carrot *0.01
Strawberry 0.2
Agvet chemical: azoxystrobin
Permitted residue – azoxystrobin
Maize *0.01
Agvet chemical: cyproconazole
Permitted residue – cyproconazole, sum of isomers
Maize *0.01
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 26
Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code
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 (AEDT) 4 JANUARY 2021
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.
Please note: submissions will be published on the APVMA’s website, unless you have asked for the submission to
remain confidential, or if the APVMA chooses at its discretion not to publish any submissions received (refer to the public
consultation coversheet).
Please lodge your submission using the public consultation coversheet, which provides options for how your submission
will be published.
Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may
be required to be released under that Act should a request for access be made.
For further information please contact:
MRL Contact Officer
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2401
Email: [email protected]
https://apvma.gov.au/node/72856https://apvma.gov.au/node/72856https://apvma.gov.au/node/72856mailto:[email protected]
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 27
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
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 proposals (No. 7) gazetted on 8 September 2020 (No. APVMA 18).
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
10, 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.
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 Officer
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2383
Email: [email protected]
http://www.legislation.gov.au/http://www.legislation.gov.au/mailto:[email protected]
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 28
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Australia New Zealand Food Standards Code – Schedule 20 – Maximum residue limits Variation
Instrument No. APVMA 9, 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 Lutze
Delegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines
Authority
Dated this Twenty Fourth day of November 2020
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 29
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Part 1 Preliminary
1 Name of instrument
This instrument is the Australia New Zealand Food Standards Code – Schedule 20 Maximum residue limits Variation Instrument No. APVMA 9. 2020 (Amendment Instrument).
2 Commencement
In 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 Object
The object of this instrument is for the APVMA to make variations to Schedule 20 Maximum 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 Interpretation
In this instrument:
APVMA means the Australian Pesticides and Veterinary Medicines Authority established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; and
Principal Instrument means Schedule 20 – Maximum 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 20
The Schedule to this instrument sets out the variations made to the Principal Instrument by this instrument.
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 30
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Schedule
Variations to Schedule 20 – Maximum residue limits
[1] The table to section S20 – 3 in Schedule 20 is varied by
[1.1] omitting from each of the following chemicals, the foods and associated MRLs
Agvet chemical: metribuzin
Permitted residue – metribuzin
Root and tuber vegetables [except carrot; potato]
T*0.05
Agvet chemical: pyraflufen-ethyl
Permitted residue – sum of pyraflufen-ethyl and its acid metabolite (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxyacetic acid)
Broad bean (dry) (fava bean) *0.02
Field bean (dry) *0.02
Agvet chemical: saflufenacil
Permitted residue – commodities of plant origin: sum of saflufenacil, N′-{2-chloro-4-fluoro-5-[1,2,3,6-tetrahydro-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]benzoyl-N-isopropyl sulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino} carbonyl)phenyl]urea, expressed as saflufenacil equivalents
Permitted residue – commodities of animal origin: saflufenacil
Cereal grains 0.2
[1.2] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order
Agvet chemical: imidacloprid
Permitted residue – sum of imidacloprid and metabolites containing the 6-chloropyridinylmethylene moiety, expressed as imidacloprid
Galangal, lesser T0.05
Ginger, Japanese T0.05
Agvet chemical: pyraflufen-ethyl
Permitted residue – sum of pyraflufen-ethyl and its acid metabolite (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxyacetic acid)
Pulses *0.02
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 31
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Agvet chemical: saflufenacil
Permitted residue – commodities of plant origin: sum of saflufenacil, N′-{2-chloro-4-fluoro-5-[1,2,3,6-tetrahydro-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]benzoyl-N-isopropyl sulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino} carbonyl)phenyl]urea, expressed as saflufenacil equivalents
Permitted residue – commodities of animal origin: saflufenacil
Cereal grains (except rice) 0.2
Rice *0.01
[1.3] omitting for each of the following chemicals, the maximum residue limit for the food and substituting
Agvet chemical: clothianidin
Permitted residue: clothianidin
see also thiamethoxam
Almonds 0.05
Agvet chemical: fluralaner
Permitted residue – fluralaner
Cattle fat T0.7
Cattle kidney T0.25
Cattle liver T0.6
Cattle muscle T0.07
Agvet chemical: metribuzin
Permitted residue – metribuzin
Ginger root T*0.01
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 32
Stop Supply: Fleamail Pty Ltd (ACN 637 942 128)
Stop Supply: Fleamail Pty Ltd (ACN 637 942 128)
NOTICE UNDER SECTION 103 OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE SCHEDULED TO
THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994 (CTH) (AGVET CODE) – NO. 23 OF 2020
On 24 November 2020, the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to
Fleamail Pty Ltd ACN 637 942 128 (‘the Company’), pursuant to section 103 of the Agvet Code in relation to the
registered chemical products set out in the Schedule below (‘the Products’).
This notice required the Company to immediately not supply, or stop supplying, to any person, stocks of the Products
which do not have an Approved Label.
PRODUCTS WITH AN APVMA APPROVED LABEL ARE NOT AFFECTED BY THIS NOTICE.
COMPANY DETAILS
Fleamail Pty Ltd ACN 637 942 128
Level 3, 155 Queen Street
Brisbane City QLD 4000
APVMA CONTACT
For further information please contact:
Director, Compliance and Monitoring
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2304
Email: [email protected]
mailto:[email protected]
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 33
Stop Supply: Fleamail Pty Ltd (ACN 637 942 128)
SCHEDULE OF PRODUCTS
Product name APVMA approval number
Simparica Chews for Dogs 1.3 – 2.5 kg 80951
Simparica Chews for Dogs 2.6 – 5 kg 80950
Simparica Chews for Dogs 5.1 – 10 kg 80949
Simparica Chews for Dogs 10.1 – 20 kg 80948
Simparica Chews for Dogs 20.1 – 40 kg 80945
Simparica Chews for Dogs 40.1 – 60 kg 80943
Valuheart Monthly Heartworm Tablets for Small Dogs 66289
Valuheart Monthly Heartworm Tablets for Large Dogs 66288
Valuheart Monthly Heartworm Tablets for Medium Dogs 66287
Cazitel Flavoured Allwormer Tablets for Dogs 66818
Cazitel Flavoured Allwormer Tablets for Large Dogs 66816
Revolution for Puppies And Kittens 50867
Revolution for Cats 50881
Revolution Plus (selamectin/sarolaner) monthly topical solution for large cats
5.1 – 10 kg
87222
Revolution Plus (selamectin/sarolaner) monthly topical solution for medium cats
2.6 – 5 kg
87224
Revolution Plus (selamectin/sarolaner) monthly topical solution for small cats
and kittens 1.25 – 2.5 kg
87225
Advocate for Kittens and Small Cats up to 4 kg 55325
Advocate for Cats Over 4 kg 55326
Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 34
Stop Supply: Ausrichter Pty Ltd (ACN 000 908 529)
Stop Supply: Ausrichter Pty Ltd (ACN 000 908 529)
NOTICE UNDER SECTION 102 OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE SCHEDULED TO
THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994 (CTH) (AGVET CODE) – NO. 24 OF 2020
On 20 November 2020, the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to
Ausrichter Pty Ltd (ACN 000 908 529) (‘the Company’), pursuant to section 102 of the Agvet Code in relation to the
registered chemical product labelled or known as Equisedan Vet 10 mg/ml Solution for injection
(APVMA 61880/10 ml/109), labelled or known as batch 5823-04.
This notice required the Company to immediately stop supply of all stocks of batch 5823-04 of Equisedan Vet 10 mg/ml
Solution for injection; to immediately notify any person who has possession or custody of stocks of batch 5823-04 of
Equisedan Vet 10 mg/ml Solution for injection (either directly or indirectly because of a supply by the Company) that they
must stop supply of stocks of batch 5823-04 of Equisedan Vet 10 mg/ml Solution for injection and return it to the
Company immediately; take all necessary steps to recover all stocks of batch 5823-04 of Equisedan Vet 10 mg/ml
Solution for injection from any person to whom the Company has either directly or indirectly supplied batch 5823-04 of
Equisedan Vet 10 mg/ml Solution for injection; appropriately test any recovered units of batch 5823-04 of the product
Equisedan Vet 10 mg/ml Solution for injection to ensure that they meet the safety, trade and efficacy criteria before
resupply; and quarantine or destroy any defective units of batch 5823-04 of Equisedan Vet 10 mg/ml Solution for
injection in the possession or custody of, or recovered by, the Company.
SUPPLIER DETAILS
Ausrichter Pty Ltd (ACN 000 908 529)
Unit 2/21 Chester Street
Camperdown NSW 2050
APVMA CONTACT
For further information please contact:
Director, Compliance and Monitoring
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2304 Email: [email protected]
mailto:[email protected]
Agricultural Chemical Products and Approved Labels Veterinary Chemical Products and Approved Labels Approved Active Constituents New Agricultural Active Constituent: Acequinocyl 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 Stop Supply: Fleamail Pty Ltd (ACN 637 942 128) Stop Supply: Ausrichter Pty Ltd (ACN 000 908 529)