APVMA Gazette No. 9, 4 May 2021 · Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May...
Transcript of APVMA Gazette No. 9, 4 May 2021 · Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May...
Gazette
Agricultural and
Veterinary Chemicals
No. APVMA 9, Tuesday, 4 May 2021
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 2021
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any
process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and
inquiries concerning reproduction and rights should be addressed to:
Assistant Director, Communications
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Email: [email protected]
Website: apvma.gov.au
GENERAL INFORMATION
The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of
the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as requi red
by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material
issued by the APVMA.
Pursuant to section 8J(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications
made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in
quarterly statistical reports.
DISTRIBUTION AND SUBSCRIPTION
The APVMA Gazette is published in electronic format only and is available from the APVMA website.
If you would like to subscribe to receive email notification when a new edition is published, please complete the subscription
form.
APVMA CONTACTS
For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6770 2300.
For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 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: polyoxin D zinc salt technical concentrate ............................................................. 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 ........................................................... 26
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 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 EXSITING ACTIVE CONSTITUENTS
Application no.: 129486
Product name: IW Formaldehyde Solution
Active constituent/s: 400 g/L formaldehyde
Applicant name: IWTS Group Pty Ltd
Applicant ACN: 152 692 969
Summary of use: For use as a disinfectant for poultry houses
Date of registration: 13 April 2021
Product registration no.: 90609
Label approval no.: 90609/129486
Application no.: 130350
Product name: Nufarm Low Volume Application Spreader
Active constituent/s: 500 g/L trisiloxane ethoxylate
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of use: For use as a low volume application spreader to be used with a range of fungicides, insecticides, plant regulators and foliar nutrients
Date of registration: 14 April 2021
Product registration no.: 90892
Label approval no.: 90892/130350
Application no.: 125251
Product name: Raticate All-Weather Block - Difenacoum
Active constituent/s: 0.05 g/kg difenacoum
Applicant name: Freezone Public Health Pty Ltd
Applicant ACN: 132 080 098
Summary of use: For the control of rats and mice in and around buildings
Date of registration: 14 April 2021
Product registration no.: 89556
Label approval no.: 89556/125251
Application no.: 125253
Product name: Raticate All-Weather Block - Brodifacoum
Active constituent/s: 0.05 g/kg brodifacoum
Applicant name: Freezone Public Health Pty Ltd
Applicant ACN: 132 080 098
Summary of use: For the control of rats and mice in and around buildings
Date of registration: 14 April 2021
Product registration no.: 89557
Label approval no.: 89557/125253
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 5
Agricultural Chemical Products and Approved Labels
Application no.: 129936
Product name: BroadForce MA Selective Herbicide
Active constituent/s: 200 g/L bromoxynil present as the octanoate, 200 g/L MCPA present as the ethyl hexyl ester
Applicant name: EnviroMint Ltd
Applicant ACN: N/A
Summary of use: For the control of weeds in commercial and home garden situations
Date of registration: 16 April 2021
Product registration no.: 90749
Label approval no.: 90749/129936
Application no.: 124858
Product name: RAMIK Bars Rodenticide
Active constituent/s: 50 mg/kg diphacinone
Applicant name: Neogen Corporation
Applicant ACN: N/A
Summary of use: For the control of mice in and around industrial, commercial, agricultural and domestic buildings
Date of registration: 16 April 2021
Product registration no.: 89433
Label approval no.: 89433/124858
Application no.: 129680
Product name: Apparent Imazing Herbicide
Active constituent/s: 33 g/L imazamox present as the ammonium salt, 15 g/L imazapyr present as the ammonium salt
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of use: For the early post-emergence control of certain annual grass and broadleaf weeds in imidazolinone-tolerant wheat, imidazolinone-tolerant barley and imidazolinone-tolerant canola
Date of registration: 16 April 2021
Product registration no.: 90651
Label approval no.: 90651/129680
Application no.: 129637
Product name: Trio Bromoxynil MCPA 200 EC Herbicide
Active constituent/s: 200 g/L bromoxynil present as the octanoate, 200 g/L MCPA present as the ethyl hexyl ester
Applicant name: CTS Chemicals Pty Ltd
Applicant ACN: 505 759 644
Summary of use: For the control of weeds in wheat, barley, cereal rye, triticale, linseed, grass pastures and turf
Date of registration: 17 April 2021
Product registration no.: 90631
Label approval no.: 90631/129637
Application no.: 127234
Product name: Titan Diflufenican Bromoxynil MCPA Herbicide
Active constituent/s: 250 g/L MCPA present as the ethyl hexyl ester, 150 g/L bromoxynil present as the octanoate, 25 g/L diflufenican
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of use: For the control of certain broadleaf weeds in winter cereals
Date of registration: 15 April 2021
Product registration no.: 90054
Label approval no.: 90054/127234
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 6
Agricultural Chemical Products and Approved Labels
Application no.: 125677
Product name: Shin Etsu MD C Flex Pheromone Mating Disruption Agent
Active constituent/s: 41.7 g/400 dispensers (E,E) 8,10 dodecadien-1-ol, 21.7 g/400 dispensers dodecanol, 5.1 g/400 dispensers tetradecanol
Applicant name: Shin Etsu Chemical Co Ltd
Applicant ACN: N/A
Summary of use: For management of codling moth (Cydia pomonella) in apples and pears
Date of registration: 19 April 2021
Product registration no.: 89649
Label approval no.: 89649/125677
Application no.: 126640
Product name: International Micron One Ablative Antifouling
Active constituent/s: Red: 516 g/L copper present as cuprous oxide, 46 g/L zineb. Blue: 514 g/L copper present as cuprous oxide, 46 g/L zineb. Black: 514 g/L copper present as cuprous oxide, 46 g/L zineb. Dover white: 489 g/L copper present as cuprous oxide, 44 g/L zineb
Applicant name: Akzo Nobel Pty Ltd
Applicant ACN: 000 119 424
Summary of use: For use below the waterline on vessels to prevent marine growth
Date of registration: 19 April 2021
Product registration no.: 89985
Label approval no.: 89985/126640
Application no.: 129639
Product name: MLChem Spray Grade Ammonium Sulphate 980 Herbicide Adjuvant
Active constituent/s: 980 g/kg ammonium sulphate
Applicant name: AgMerch Pty Ltd
Applicant ACN: 645 371 017
Summary of use: For use with glyphosate based herbicides to minimise antagonism when tank mixing with flowable herbicides, and to improve performance under adverse environmental conditions
Date of registration: 19 April 2021
Product registration no.: 90633
Label approval no.: 90633/129639
Application no.: 129642
Product name: Submarino Glyphosate 540 K Herbicide
Active constituent/s: 540 g/L glyphosate present as the potassium salt
Applicant name: Submarino Pty Ltd
Applicant ACN: 616 055 559
Summary of use: For the control of many annual and perennial weeds
Date of registration: 19 April 2021
Product registration no.: 90634
Label approval no.: 90634/129642
Application no.: 129652
Product name: CropSure Putback 250SC Plant Growth Regulator
Active constituent/s: 250 g/L paclobutrazol
Applicant name: CropSure Pty Ltd
Applicant ACN: 643 829 190
Summary of use: To reduce vegetative growth in mango, stone fruit and apple trees
Date of registration: 20 April 2021
Product registration no.: 90638
Label approval no.: 90638/129652
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 7
Agricultural Chemical Products and Approved Labels
Application no.: 127100
Product name: Quali-Pro Nutmeg Herbicide
Active constituent/s: 480 g/L bentazone present as sodium salt
Applicant name: ADAMA Australia Pty Ltd
Applicant ACN: 050 328 973
Summary of use: For control of nutgrass, Mullumbimby couch and certain broadleaf weeds in turf
Date of registration: 20 April 2021
Product registration no.: 90028
Label approval no.: 90028/127100
Application no.: 129669
Product name: Deadant Fire Ant & Nuisance Ants Killer Granules
Active constituent/s: 0.25 g/kg fipronil
Applicant name: Sundew Solutions Pty Ltd
Applicant ACN: 135 400 261
Summary of use: For control of argentine stem weevil and ants (including fire ants) in lawns, external surrounds of buildings and structures in the home garden
Date of registration: 20 April 2021
Product registration no.: 90647
Label approval no.: 90647/129669
Application no.: 124752
Product name: Termicoat
Active constituent/s: 108 g/L of boron present as 350 g/L disodium octoborate tetrahydrate, 200 g/L orthoboric acid, 20 g/L benzalkonium chloride
Applicant name: Ian Marchesi
Applicant ACN: N/A
Summary of use: For control of termites, borers and insects in timber and masonry
Date of registration: 21 April 2021
Product registration no.: 89414
Label approval no.: 89414/124752
Application no.: 129692
Product name: Sanonda Fluroxypyr 400 Herbicide
Active constituent/s: 400 g/L fluroxypyr present as the methyl heptyl ester
Applicant name: Sanonda (Australia) Pty Ltd
Applicant ACN: 059 813 973
Summary of use: For the control of a wide range of broadleaf weeds
Date of registration: 21 April 2021
Product registration no.: 90653
Label approval no.: 90653/129692
Application no.: 124978
Product name: Worthide Xtra Insecticide
Active constituent/s: 500 g/kg pymetrozine
Applicant name: Shandong Rainbow International Co Ltd
Applicant ACN: N/A
Summary of use: For the control of aphids in cotton, brassica vegetables, potatoes and stone fruit
Date of registration: 21 April 2021
Product registration no.: 89471
Label approval no.: 89471/124978
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 8
Agricultural Chemical Products and Approved Labels
Application no.: 129638
Product name: Earthcare Organic Weedkiller Ready To Use
Active constituent/s: 36.8 g/L nonanoic acid
Applicant name: Seasol International Pty Ltd
Applicant ACN: 006 490 240
Summary of use: For the control of weeds, moss and algae in gardens, paths and driveways
Date of registration: 22 April 2021
Product registration no.: 90632
Label approval no.: 90632/129638
Application no.: 129799
Product name: Gro-Sure Fluroxypyr 200 Herbicide
Active constituent/s: 200 g/L fluroxypyr present as the methyl heptyl ester
Applicant name: Agritrading Pty Ltd
Applicant ACN: 134 291 295
Summary of use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, millets, pastures, sorghum, sugar cane, sweet corn and winter cereals. Also for the control of woody weeds in agricultural non-crop areas, commercial and industrial areas, pastures and right-of-ways
Date of registration: 22 April 2021
Product registration no.: 90693
Label approval no.: 90693/129799
Application no.: 129699
Product name: CropSure Garnisha 600EC Herbicide
Active constituent/s: 600 g/L triclopyr present as the butoxyethyl ester
Applicant name: CropSure Pty Ltd
Applicant ACN: 643 829 190
Summary of use: For the control of various woody and broadleaf weeds
Date of registration: 22 April 2021
Product registration no.: 90658
Label approval no.: 90658/129699
Application no.: 125875
Product name: Prolink Liquid Larvicide Concentrate
Active constituent/s: 205.2 g/L (S)-methoprene
Applicant name: Wellmark International (Australia) Pty Ltd
Applicant ACN: 099 307 007
Summary of use: For the prevention of adult mosquito emergence in a range of natural water harbourages
Date of registration: 22 April 2021
Product registration no.: 89714
Label approval no.: 89714/125875
Application no.: 129747
Product name: Agro-Essence Clethodim 360 EC Herbicide
Active constituent/s: 360 g/L clethodim
Applicant name: Agro-Alliance (Australia) Pty Ltd
Applicant ACN: 130 864 603
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, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans
Date of registration: 22 April 2021
Product registration no.: 90675
Label approval no.: 90675/129747
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 9
Agricultural Chemical Products and Approved Labels
Application no.: 126351
Product name: Clama 50SC Insecticide
Active constituent/s: 50 g/L emamectin present as emamectin benzoate
Applicant name: AgriNova New Zealand Limited
Applicant ACN: N/A
Summary of use: For the control of certain insect pests in brassica vegetables, grapes, capsicum, lettuce, sweet corn and tomatoes
Date of registration: 23 April 2021
Product registration no.: 89922
Label approval no.: 89922/126351
Application no.: 129854
Product name: Trio Bromoxynil 250 Diflufenican 25 EC Herbicide
Active constituent/s: 250 g/L bromoxynil present as the octanoate ester, 25 g/L diflufenican
Applicant name: CTS Chemicals Pty Ltd
Applicant ACN: 605 759 644
Summary of use: For the control of certain broadleaf weeds in winter cereals and pastures
Date of registration: 23 April 2021
Product registration no.: 90709
Label approval no.: 90709/129854
2. VARIATIONS OF REGISTRATION
Application no.: 130473
Product name: Dreamstate Australian Bed Bug Killing Powder
Active constituent/s: 900 g/kg amorphous silica
Applicant name: Bed Bug Wholesale
Applicant ACN: N/A
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Trident Australian Bed Bug Killing Powder’ to ‘Dreamstate Australian Bed Bug Killing Powder ’
Date of variation: 7 April 2021
Product registration no.: 88325
Label approval no.: 88325/130473
Application no.: 130511
Product name: Smart Scavenge Sterilised Grain Mouse Bait
Active constituent/s: 25 g/kg zinc phosphide
Applicant name: Crop Smart Pty Ltd
Applicant ACN: 093 927 961
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Smart Terminator Grain Mouse Bait’ to ‘Smart Scavenge Sterilised Grain Mouse Bait’
Date of variation: 8 April 2021
Product registration no.: 90334
Label approval no.: 90334/130511
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 10
Agricultural Chemical Products and Approved Labels
Application no.: 126333
Product name: Cavalier 500 SC Herbicide
Active constituent/s: 500 g/L oxyfluorfen
Applicant name: ADAMA Australia Pty Ltd
Applicant ACN: 050 328 973
Summary of variation: To add integrated vegetation management use in industrial areas, non-crop situations, roadside, rail and rights of way and in ornamental trees and to amend personal protective equipment for aerial and backpack applications
Date of variation: 12 April 2021
Product registration no.: 81077
Label approval no.: 81077/126333
Application no.: 130541
Product name: Greenzone Termite Perimeter System
Active constituent/s: 1.2 g/kg bifenthrin
Applicant name: Green Zone Pty Ltd
Applicant ACN: 146 150 316
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Greenzone Perimeter System’ to ‘Greenzone Termite Perimeter System’
Date of variation: 12 April 2021
Product registration no.: 89294
Label approval no.: 89254/130541
Application no.: 130527
Product name: Hy-Clor Blackout
Active constituent/s: 18.2 g/L copper (Cu) present as a complex blend of copper salts, 96 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 ‘Hy-Clor SaltActive Salt Water Algaecide’ to ‘Hy-Clor SaltActiv Salt Water Algaecide’
Date of variation: 12 April 2021
Product registration no.: 66999
Label approval no.: 66999/130527
Application no.: 130542
Product name: Bromakil Power Block For Rats And Mice
Active constituent/s: 0.05 g/kg bromadiolone
Applicant name: Liphatech S.A.S.
Applicant ACN: N/A
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Generation Green Rodenticide Block’ to ‘Bromakil Power Block For Rats and Mice’
Date of variation: 12 April 2021
Product registration no.: 80388
Label approval no.: 80388/130542
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 11
Agricultural Chemical Products and Approved Labels
Application no.: 129488
Product name: Sabakem Imidacloprid 350SC Soil Insecticide
Active constituent/s: 350 g/L imidacloprid
Applicant name: Sabakem Pty Ltd
Applicant ACN: 151 682 138
Summary of variation: To add uses for banana weevil borer in bananas (lady finger) and banana rust and weevil borer in banana (cavendish)
Date of variation: 13 April 2021
Product registration no.: 69122
Label approval no.: 69122/129488
Application no.: 129054
Product name: Salve Herbicide
Active constituent/s: 375 g/kg aminopyralid, 300 g/kg metsulfuron-methyl
Applicant name: Grow Choice Pty Ltd
Applicant ACN: 161 264 884
Summary of variation: To add uses for control of weeds in wheat, barley, triticale and cereal rye
Date of variation: 13 April 2021
Product registration no.: 88260
Label approval no.: 88260/129054
Application no.: 129472
Product name: AC Pulverize 75-D Herbicide
Active constituent/s: 300 g/L 2,4-D present as the triisopropyl amine salt, 75 g/L picloram present as the triisopropyl amine salt
Applicant name: Axichem Pty Ltd
Applicant ACN: 131 628 594
Summary of variation: To amend the product label in line with the 2,4-D reconsideration final regulatory decision and add the uses in agricultural non-crop areas, commercial and industrial areas, pastures and rights of way under the permit to label project
Date of variation: 13 April 2021
Product registration no.: 64859
Label approval no.: 64859/129472
Application no.: 129618
Product name: Farmalinx 2,4-D 625 Herbicide
Active constituent/s: 625 g/L 2,4-D present as the dimethylamine and diethanolamine salts
Applicant name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of variation: To amend the product label in line with the 2,4-D reconsideration final regulatory decision and add uses in fallow, hardwood and softwood plantations, cavendish bananas, agricultural non-crop areas, commercial and industrial areas, pastures, rights of way and oil tea tree under the permit to label project
Date of variation: 16 April 2021
Product registration no.: 64351
Label approval no.: 64351/129618
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 12
Agricultural Chemical Products and Approved Labels
Application no.: 125798
Product name: Ambitious Plant Growth Regulator
Active constituent/s: 10 g/L forchlorfenuron
Applicant name: AgriNova New Zealand Limited
Applicant ACN: 34 004 099 592
Summary of variation: To extend the use to apples and cherries
Date of variation: 19 April 2021
Product registration no.: 65381
Label approval no.: 65381/125798
Application no.: 129643
Product name: Macspred Trimac Industrial Herbicide
Active constituent/s: 880 g/kg terbacil, 40 g/kg sulfometuron-methyl
Applicant name: Macspred Pty Ltd.
Applicant ACN: 011 029 495
Summary of variation: To add the use in eucalypt plantations
Date of variation: 19 April 2021
Product registration no.: 54812
Label approval no.: 54812/129643
Application no.: 129651
Product name: Instar Granular Insecticide
Active constituent/s: 0.25 g/kg fipronil
Applicant name: Sundew Solutions Pty Ltd
Applicant ACN: 135 400 261
Summary of variation: To add control of red imported fire ant and yellow crazy ant and updating the first aid instructions
Date of variation: 20 April 2021
Product registration no.: 68975
Label approval no.: 68975/129651
Application no.: 129475
Product name: Dithane Rainshield Neo Tec Fungicide
Active constituent/s: 750 g/kg mancozeb
Applicant name: Corteva Agriscience Australia Pty Ltd
Applicant ACN: 003 771 659
Summary of variation: To update the first aid instructions and safety directions as per the FAISD Handbook
Date of variation: 20 April 2021
Product registration no.: 59688
Label approval no.: 59688/129475
Application no.: 128897
Product name: Thiragranz Fungicide
Active constituent/s: 800 g/kg thiram
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of variation: To add new uses in avocado and mango and extend vegetable uses to cover beans, cabbage and carrot
Date of variation: 21 April 2021
Product registration no.: 48621
Label approval no.: 48621/128897
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 13
Agricultural Chemical Products and Approved Labels
Application no.: 126142
Product name: Nufarm Intercept Herbicide
Active constituent/s: 33 g/L imazamox as the ammonium salt, 15 g/L imazapyr present as the ammonium salt
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of variation: To add use in imidazolinone herbicide tolerant faba beans
Date of variation: 21 April 2021
Product registration no.: 69353
Label approval no.: 69353/126142
Application no.: 125939
Product name: Amistar Xtra Fungicide
Active constituent/s: 200 g/L azoxystrobin, 80 g/L cyproconazole
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of variation: To include the control of various diseases in pulses, sweet corn and maize
Date of variation: 22 April 2021
Product registration no.: 57949
Label approval no.: 57949/125939
Application no.: 125820
Product name: Versys Insecticide
Active constituent/s: 100 g/L afidopyropen
Applicant name: BASF Australia Ltd
Applicant ACN: 008 437 867
Summary of variation: To extend uses to barley, wheat, canola and certain horticultural crops; to add claims for additional pests; and to allow aerial application in broadacre crops
Date of variation: 23 April 2021
Product registration no.: 82738
Label approval no.: 82738/125820
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 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.: 129499
Product name: Ceftiofur – Ketoprofen Injectable
Active constituent/s: 150 mg/mL ketoprofen, 50 mg/mL ceftiofur (as hydrochloride)
Applicant name: South Yarra Pharma Pty Ltd
Applicant ACN: 629 173 351
Summary of use: For the treatment of bovine respiratory disease (BRD) caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to ceftiofur and the reduction of associated clinical signs of inflammation or pyrexia
Date of registration: 15 April 2021
Product registration no.: 90614
Label approval no.: 90614/129499
Application no.: 129856
Product name: Prolet 20 Mg Tablets For Dogs
Active constituent/s: 20 mg/tablets carprofen
Applicant name: Jurox Pty Ltd
Applicant ACN: 000 932 230
Summary of use: For the relief of pain and inflammation in dogs
Date of registration: 15 April 2021
Product registration no.: 90710
Label approval no.: 90710/129856
Application no.: 123962
Product name: Nilablend Lasalocid/Nicarbazin Anticoccidial Premix
Active constituent/s: 100 g/kg lasalocid sodium, 100 g/kg nicarbazin
Applicant name: Zoetis Australia Pty Ltd
Applicant ACN: 156 476 425
Summary of use: For the prevention of coccidiosis in broiler chickens caused by E acervulina, E maxima, E tenella, E brunetti, E necatrix, E mitis and E praecox
Date of registration: 19 April 2021
Product registration no.: 89199
Label approval no.: 89199/123962
Application no.: 129636
Product name: Vetmec Moxiguard Long Acting Injection For Sheep
Active constituent/s: 20 g/L moxidectin
Applicant name: Chemvet Australia Pty Ltd
Applicant ACN: 138 711 289
Summary of use: For the registration of an injectable parasiticide indicated for the treatment and control of roundworms, nasal bot and itchmite in sheep and for protection against barber's pole for up to 4 months
Date of registration: 21 April 2021
Product registration no.: 90630
Label approval no.: 90630/129636
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 15
Veterinary Chemical Products and Approved Labels
Application no.: 129671
Product name: Proguard Jetting Liquid Sheep Blowfly Treatment
Active constituent/s: 500 g/L cyromazine
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of use: For the protection of long wool sheep against strike by blowfly (Lucilia cuprina), including organophosphate resistant strains
Date of registration: 23 April 2021
Product registration no.: 90649
Label approval no.: 90649/129671
2. LISTED REGISTRATIONS
Application no.: 129224
Product name: Zamijoint For Dogs
Active constituent/s: 560 mg/g glucosamine hydrochloride (shellfish origin), 336 mg/g chondroitin sulphate (bovine origin)
Applicant name: Zamira Life Sciences Pty Ltd
Applicant ACN: 130 641 502
Summary of use: For the long-term use to help improve joint health and function in dogs
Date of registration: 13 April 2021
Product registration no.: 90533
Label approval no.: 90533/129224
3. VARIATIONS OF REGISTRATION
Application no.: 129481
Product name: Randlab Meloxicam Injection Anti-inflammatory Injection
Active constituent/s: 20 mg/mL meloxicam
Applicant name: Randlab Australia Pty Ltd
Applicant ACN: 114 948 837
Summary of variation: To vary the product registration and label approval to extend the use to sheep and align the label with the Veterinary Labelling Code
Date of variation: 14 April 2021
Product registration no.: 68070
Label approval no.: 68070/129481
4. VARIATION OF LABEL APPROVAL
Application no.: 129614
Product name: Apex Clindamycin 75 Tablets
Active constituent/s: 75 mg/tablet clindamycin as clindamycin hydrochloride
Applicant name: Dechra Veterinary Products (Australia) Pty Ltd
Applicant ACN: 614 716 700
Summary of variation: To amend the dosage and administration and storage sections of the label as well as to update the label to the current Veterinary Labelling Code
Date of variation: 15 April 2021
Product registration no.: 87331
Label approval no.: 87331/129614
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 16
Veterinary Chemical Products and Approved Labels
Application no.: 129615
Product name: Apex Clindamycin 150 Tablets
Active constituent/s: 150 mg/tablet clindamycin as clindamycin hydrochloride
Applicant name: Dechra Veterinary Products (Australia) Pty Ltd
Applicant ACN: 614 716 700
Summary of variation: To amend the dosage and administration and storage sections of the label and update the label to the current Veterinary Labelling Code
Date of variation: 15 April 2021
Product registration no.: 70247
Label approval no.: 70247/129615
Application no.: 129493
Product name: Eimeriavax 3M
Active constituent/s: Eimeria acervulina strain RA3+20 (greater or equal to) 50 oocysts, eimeria maxima strain MCK+10 (greater or equal to) 100 oocysts, eimeria tenella strain Rt3+15 (greater or equal to) 150 oocysts
Applicant name: Eimeria Pty Ltd
Applicant ACN: 075 153 472
Summary of variation: To update label instructions for diluting the vaccine
Date of variation: 16 April 2021
Product registration no.: 63631
Label approval no.: 63631/129493
Application no.: 124472
Product name: Ceva Ketamine Injection
Active constituent/s: 100 mg/mL ketamine as hydrochloride
Applicant name: Ceva Animal Health Pty Ltd
Applicant ACN: 002 692 426
Summary of variation: To include in-use shelf life statement
Date of variation: 23 April 2021
Product registration no.: 37711
Label approval no.: 37711/124472
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 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.: 130075
Active constituent/s: Oestriol
Applicant name: Intervet Australia Pty Ltd
Applicant ACN: 008 467 034
Summary of use: For use in veterinary chemical products
Date of approval: 12 April 2021
Approval no.: 90810
Application no.: 129969
Active constituent/s: Pentobarbital sodium
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of use: For use in veterinary chemical products
Date of approval: 14 April 2021
Approval no.: 90759
Application no.: 129134
Active constituent/s: Neomycin sulfate
Applicant name: Avet Health Pty Ltd
Applicant ACN: 616 838 101
Summary of use: For use in veterinary chemical products
Date of approval: 14 April 2021
Approval no.: 90499
Application no.: 129184
Active constituent/s: Lufeneron
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of use: For use in veterinary chemical products
Date of approval: 16 April 2021
Approval no.: 90513
Application no.: 128850
Active constituent/s: Meloxicam
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of use: For use in veterinary chemical products
Date of approval: 16 April 2021
Approval no.: 90428
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 18
Approved Active Constituents
Application no.: 125407
Active constituent/s: Nicarbazin
Applicant name: Zoetis Australia Pty Ltd
Applicant ACN: 156 476 425
Summary of use: For use in veterinary chemical products
Date of approval: 19 April 2021
Approval no.: 89603
Application no.: 126531
Active constituent/s: Cyromazine
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of use: For use in veterinary chemical products
Date of approval: 19 April 2021
Approval no.: 89963
Application no.: 126191
Active constituent/s: Metribuzin
Applicant name: Agrow Allied Ventures Pvt Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 19 April 2021
Approval no.: 89825
Application no.: 127937
Active constituent/s: Trifluralin
Applicant name: Zhejiang Yingxin Chemical Co Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 20 April 2021
Approval no.: 90187
Application no.: 127942
Active constituent/s: Pyroxasulfone
Applicant name: Grow Choice Pty Ltd
Applicant ACN: 161 264 884
Summary of use: For use in agricultural chemical products
Date of approval: 20 April 2021
Approval no.: 90188
2. VARIATIONS OF ACTIVE CONSTITUENT
Application no.: 130113
Active constituent/s: Triamcinolone acetonide
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 April 2021
Approval no.: 84374
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 19
New agricultural active constituent: polyoxin D zinc salt technical concentrate
New agricultural active constituent: polyoxin D zinc salt technical concentrate
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has an application for the approval of a new
agricultural active constituent, polyoxin D zinc salt (which will be manufactured as a technical concentrate of the active
constituent), for use as a fungicide.
Common name: Polyoxin D zinc salt
IUPAC name: Zinc 5-(2-amino-5-O-carbamoyl-2-deoxy-L-xylonamido)-1-(5-carboxy-1,2,3,4-
tetrahydro-2,4-dioxopyrimidinyl)-1,5-dideoxy- ß-D-allofuranuronate
Chemical abstracts name: Zinc 5-[[2-amino-5-O-(aminocarbonyl)-2-deoxy-L-xylonoyl]amino]-1-(5-carboxy-3,4-
dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,5-dideoxy-β-D-allofuranuronate
CAS number: 146659-78-1 (1:1 zinc salt)
Molecular formula: C17H21N5O14Zn (1:1 zinc salt)
Molecular weight: 586.76 g/mol (1:1 zinc salt)
Structure:
Chemical family: Peptide nucleosides.
Mode of action: Polyoxin D, the active portion of the polyoxin D zinc salt, competitively inhibits chitin
synthase enzymes, leading to inhibition of septation, chaining, and osmotic swelling
of the fungal cell.
SUMMARY OF THE APVMA’S EVALUATION
The APVMA has evaluated the chemistry aspects of polyoxin D zinc salt technical concentrate (identification, stability,
physicochemical properties, manufacturing process, specifications, quality control procedures, batch analysis results and
analytical methods) and found them to be acceptable.
The APVMA has considered the toxicological aspects of polyoxin D zinc salt, and concluded that there are no
toxicological concerns regarding the approval of this active constituent. Neither an Acceptable Daily Intake (ADI) nor an
Acute Reference Dose (ARfD) value is required for polyoxin D zinc salt due to its anticipated low levels of residues in
food and low oral toxicity.
After consideration of recommendations by the Advisory Committee on Chemical Scheduling, the Scheduling Delegate
made a final decision to include polyoxin D zinc salt in schedule 5 of the Standard for the Uniform Scheduling of
Medicines and Poisons, with an implementation date of 1 October 2020.
On the basis of the data provided, and the toxicological assessment, it is proposed that the following active constituent
standard be established for polyoxin D zinc salt technical concentrate:
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 20
New agricultural active constituent: polyoxin D zinc salt technical concentrate
Constituent Level
Polyoxin D zinc salt 209 g/kg minimum
Other compounds of toxicological significance are not expected to occur in polyoxin D zinc salt technical concentrate
based on the raw materials and the manufacturing route used.
The APVMA is satisfied that the proposed use of polyoxin D zinc salt would not be an undue toxicological hazard to the
safety of people exposed to it during its handling and use.
MAKING A SUBMISSION
In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission
as to whether the application for approval of polyoxin D zinc salt technical concentrate 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 Chemistry and Manufacture
Risk Assessment Capability
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 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. 4) 2021
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]
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 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. 9, 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) 2021) 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 9, Tuesday, 4 May 2021 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
(4 May 2021)
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
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]
Tomato T0.5
[1.2] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order
Cyantraniliprole
Permitted residue: Cyantraniliprole
Celery T7
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]
Fruiting vegetables, other than cucurbits T0.5
Rape seed (canola) 0.5
Fluxapyroxad
Permitted residue: Fluxapyroxad
Oats T0.2
Mefentrifluconazole
Permitted residue: Mefentrifluconazole
Barley T0.2
Oats T0.2
Rape seed (canola) T0.05
Wheat T0.03
Mesotrione
Permitted residue: Mesotrione
All other foods except animal commodities
0.01
Linseed T*0.01
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 24
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
Azoxystrobin
Permitted residue: Azoxystrobin
Beetroot T*0.005
Carbendazim
Permitted residue: Sum of carbendazim and 2-aminobenzimidazole, expressed as carbendazim
Mushrooms T1
Imazapyr
Permitted residue: Imazapyr
Broad bean (dry) 0.07
Mefentrifluconazole
Permitted residue: Mefentrifluconazole
Edible offal (mammalian) T0.3
Meat (mammalian) (in the fat) T0.2
Spiroxamine
Permitted residue: Commodities of plant origin: Spiroxamine
Permitted residue: Commodities of animal origin: Spiroxamine carboxylic acid, expressed as spiroxamine
Barley 0.03
Podded pea (young pods) (snow and sugar snap)
T0.6
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 25
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 (AEST) 1 JUNE 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]
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 26
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 proposal (No. 1) gazetted on 27 January 2021 (No. APVMA 2).
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
1, 2021) 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 Officer
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2383
Email: [email protected]
Australia New Zealand Food Standards Code—Schedule 20—Maximum residue limits Variation
Instrument No. APVMA 3, 2021
I, Sheila Logan, 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.
Sheila Logan
Delegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines
Authority
Dated this Twenty-third day of April 2021
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 28
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 20maximum residue limits Variation Instrument No. APVMA 3, 2021 (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 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 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 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 29
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] inserting in alphabetical order
Agvet chemical: Fomesafen
Permitted residue: Fomesafen
Edible offal (mammalian) *0.02
Eggs *0.02
Meat (mammalian) *0.02
Milks *0.02
Poultry, Edible offal of *0.02
Poultry meat *0.02
Pulses *0.01
[1.2] omitting from each of the following chemicals, the foods and associated MRLs
Agvet chemical: Fluopyram
Permitted residue: Commodities of plant origin: Fluopyram
Permitted residue: Commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyram
Rape seed (canola) *0.01
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)
Field pea (dry) *0.02
Agvet chemical: Spinetoram
Permitted residue: Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L
Leek T0.2
Onion, bulb T*0.01
Onion, Welsh T0.3
Shallot T0.3
Spring onion T0.3
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 30
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
[1.3] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order
Agvet chemical: Azoxystrobin
Permitted residue: Azoxystrobin
Sweet corn (corn-on-the-cob) *0.01
Agvet chemical: Bromoxynil
Permitted residue: Bromoxynil
Walnuts T*0.01
Agvet chemical: Diflufenican
Permitted residue: Diflufenican
Walnuts T*0.01
Agvet chemical: Fluopyram
Permitted residue: Commodities of plant origin: Fluopyram
Permitted residue: Commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyram
Cereal grains 0.03
Lettuce, head 15
Lettuce, leaf 15
Oilseed 0.03
Agvet chemical: Spinetoram
Permitted residue: Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L
Bulb vegetables (alliums) 0.1
Cacao beans *0.01
Carob 0.1
Agvet chemical: Trifloxystrobin
Permitted residue: Sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)-ethylideneaminooxymethyl] phenyl] acetic acid), expressed as trifloxystrobin equivalents
Lettuce, head 15
Lettuce, leaf 15
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 31
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
[1.4] omitting for each of the following chemicals, the maximum residue limit for the food and substituting
Agvet chemical: Fluopyram
Permitted residue: Commodities of plant origin: Fluopyram
Permitted residue: Commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyram
All other foods except animal food commodities 0.2
Agvet chemical: Metalaxyl
Permitted residue: Metalaxyl
Walnuts T*0.01
Agvet chemical: Methomyl
Permitted residue: Methomyl
Mango T*0.01