APVMA Gazette No. 7, 7 April 2020 · 2020. 4. 7. · Gazette Agricultural and Veterinary Chemicals...
Transcript of APVMA Gazette No. 7, 7 April 2020 · 2020. 4. 7. · Gazette Agricultural and Veterinary Chemicals...
Gazette
Agricultural and
Veterinary Chemicals
No. APVMA 7, Tuesday, 7 April 2020
Published by the Australian Pesticides and Veterinary Medicines Authority
The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The
Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be
published in the Gazette containing details of the registration of agricultural and veterinary chemical products
and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code
and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet
Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.
ISSN 1837-7629
© Commonwealth of Australia 2020
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any
process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and
inquiries concerning reproduction and rights should be addressed to:
Assistant Director, Communications
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Email: [email protected]
Website: apvma.gov.au
GENERAL INFORMATION
The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of
the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as requi red
by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material
issued by the APVMA.
Pursuant to section 8J(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications
made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in
quarterly statistical reports.
DISTRIBUTION AND SUBSCRIPTION
The APVMA Gazette is published in electronic format only and is available from the APVMA website.
If you would like to subscribe to receive email notification when a new edition is published, please complete the subscription
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 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Agricultural Chemical Products and Approved Labels..................................................................................................... 4
Veterinary Chemical Products and Approved Labels .................................................................................................... 11
Approved Active Constituents ....................................................................................................................................... 14
New agricultural active constituent: trifludimoxazin ....................................................................................................... 15
New chemical product Voraxor Herbicide containing trifludimoxazin and saflufenacil .................................................. 17
Amendments to the APVMA MRL Standard .................................................................................................................. 19
Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code ................................................. 20
Variations to Schedule 20 of the Australia New Zealand Food Standards Code ........................................................... 25
Consultation on use patterns for anticoagulant rodenticide products ............................................................................ 32
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 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.: 123172
Product name: Loveland Adopt Spray Oil
Active constituent/s: 582 g/L paraffinic oil, 240 g/L alkoxylated alcohol non-ionic surfactants
Applicant name: Loveland Products Inc
Applicant ACN: N/A
Summary of use: For use to improve the spreading and wetting of herbicides, insecticides and defoliants on plant surfaces
Date of registration: 17 March 2020
Product registration no.: 89017
Label approval no.: 89017/123172
Application no.: 123543
Product name: Farmalinx Spectacle Seed Dressing
Active constituent/s: 25 g/L tebuconazole, 4 g/L triflumuron
Applicant name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of use: For control of bunt, flag smut and loose smut in wheat, covered and loose smut of barley and oats and for protection against insect pests of stored grain
Date of registration: 18 March 2020
Product registration no.: 89073
Label approval no.: 89073/123543
Application no.: 123567
Product name: Double Nozzle Technology Raid Max Flying Insect Killer
Active constituent/s: 0.5 g/kg imiprothrin, 0.5 g/kg prallethrin, 0.15 g/kg cyfluthrin
Applicant name: S.C. Johnson & Son Pty Ltd
Applicant ACN: 000 021 009
Summary of use: For the control of flying and crawling insects in household situations
Date of registration: 19 March 2020
Product registration no.: 89093
Label approval no.: 89093/123567
Application no.: 119543
Product name: Campbell EcoFOG-160 PYR Fungicide
Active constituent/s: 160 g/L pyrimethanil
Applicant name: Colin Campbell (Chemicals) Pty Ltd
Applicant ACN: 000 045 590
Summary of use: For control of postharvest diseases of apples and pears caused by Penicillium spp, Botrytis spp and Neofabrea spp
Date of registration: 19 March 2020
Product registration no.: 87843
Label approval no.: 87843/119543
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 5
Agricultural Chemical Products and Approved Labels
Application no.: 123530
Product name: Weed Force Big Cat Broadleaf Herbicide
Active constituent/s: 250 g/L MCPA as the ethyl hexyl ester, 25 g/L diflufenican
Applicant name: Weed Force Pty Ltd
Applicant ACN: 602 207 152
Summary of use: For the control of certain broadleaf weeds in winter cereals and clover
Date of registration: 20 March 2020
Product registration no.: 89063
Label approval no.: 89063/123530
Application no.: 123501
Product name: Titan Terbutryn 275 g/L + 160 g/L MCPA Herbicide
Active constituent/s: 275 g/L terbutryn, 160 g/L MCPA present as the potassium salt
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of use: For the control of seedling broadleaf weeds in wheat, barley, some varieties of oats, pasture and sugar cane
Date of registration: 20 March 2020
Product registration no.: 89049
Label approval no.: 89049/123501
Application no.: 122127
Product name: Sanonda Fungicide Flutriafol 500SC
Active constituent/s: 500 g/L flutriafol
Applicant name: Sanonda (Australia) Pty Ltd
Applicant ACN: 059 813 973
Summary of use: For the control of certain fungal diseases on wheat, barley and canola
Date of registration: 23 March 2020
Product registration no.: 88737
Label approval no.: 88737/122127
Application no.: 123574
Product name: Thanos 225 Insecticide
Active constituent/s: 225 g/L methomyl
Applicant name: Sunrise Crop Science Co Ltd
Applicant ACN: N/A
Summary of use: For the control of insect pests in various crops
Date of registration: 23 March 2020
Product registration no.: 89097
Label approval no.: 89097/123574
Application no.: 123732
Product name: Pest Controllers Own Fipronil 100 SC Termiticide & Insecticide
Active constituent/s: 100 g/L fipronil
Applicant name: Amgrow Pty Ltd
Applicant ACN: 100 684 786
Summary of use: For the protection of structures from subterranean termite damage and for the control of subterranean termites and ants around domestic and commercial structures
Date of registration: 23 March 2020
Product registration no.: 89141
Label approval no.: 89141/123732
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 6
Agricultural Chemical Products and Approved Labels
Application no.: 119532
Product name: AC Jettison 150 EC Insecticide
Active constituent/s: 150 g/L indoxacarb (S-isomer)
Applicant name: Axichem Pty Ltd
Applicant ACN: 131 628 594
Summary of use: For control of various insect pests of azuki beans, chickpeas, cotton, faba beans, mungbeans and soybeans
Date of registration: 23 March 2020
Product registration no.: 87839
Label approval no.: 87839/119532
Application no.: 123056
Product name: Kelpie Tri-S 750 Herbicide
Active constituent/s: 750 g/kg triasulfuron
Applicant name: Sinochem International Australia Pty Ltd
Applicant ACN: 160 164 616
Summary of use: For the pre-plant control of annual ryegrass, paradoxa grass and certain broadleaf weeds in wheat, and for post-emergent control of wild radish in wheat, oats and barley
Date of registration: 24 March 2020
Product registration no.: 88967
Label approval no.: 88967/123056
Application no.: 119793
Product name: Kelpie A-zine Easy Flow 600 SC Herbicide
Active constituent/s: 600 g/L atrazine
Applicant name: Sinochem International Australia Pty Ltd
Applicant ACN: 160 164 616
Summary of use: For the control of weeds and grasses in TT canola, lupins, sorghum, maize, sugarcane, lucerne, potatoes, fallow area maintenance and other situations
Date of registration: 24 March 2020
Product registration no.: 87917
Label approval no.: 87917/119793
Application no.: 119731
Product name: Conquest Vipyr 250 EC Fungicide
Active constituent/s: 250 g/L Pyraclostrobin
Applicant name: Conquest Crop Protection Pty Ltd
Applicant ACN: 098 814 932
Summary of use: For the control of leaf speckle and leaf spot in bananas; downy and powdery mildew in grapevines; husk spot in macadamia; and rust in almonds
Date of registration: 25 March 2020
Product registration no.: 87896
Label approval no.: 87896/119731
Application no.: 123566
Product name: Double Nozzle Technology Raid Max Multi Insect Killer
Active constituent/s: 0.5 g/kg imiprothrin, 0.5 g/kg prallethrin, 0.15 g/kg cyfluthrin
Applicant name: S.C. Johnson & Son Pty Ltd
Applicant ACN: 000 021 009
Summary of use: For the control of flying and crawling insects in household situations
Date of registration: 25 March 2020
Product registration no.: 89092
Label approval no.: 89092/123566
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 7
Agricultural Chemical Products and Approved Labels
Application no.: 123571
Product name: Sinon Clodinafop 240 EC Herbicide
Active constituent/s: 240 g/L clodinafop, 60 g/L cloquintocet-mexyl
Applicant name: Sinon Australia Pty Limited
Applicant ACN: 102 741 024
Summary of use: For the control of wild oats, paradoxa grass (annual phalaris), canary grass and annual ryegrass in wheat. Highly active on wild oats and can be mixed with many broadleaf herbicides
Date of registration: 27 March 2020
Product registration no.: 89094
Label approval no.: 89094/123571
2. VARIATIONS OF REGISTRATION
Application no.: 124343
Product name: Vaporooter Foaming Root Inhibitor
Active constituent/s: 510 g/kg dichlobenil, 228 g/L metham present as sodium salt
Applicant name: Duke's Root Control Inc
Applicant ACN: N/A
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Sanafoam Vaporooter ii Foaming Root Inhibitor’ to ‘Vaporooter Foaming Root Inhibitor’.
Date of variation: 5 March 2020
Product registration no.: 51811
Label approval no.: 51811/124343
Application no.: 124441
Product name: Elatus Ace Solatenol Active Fungicide
Active constituent/s: 250 g/L propiconazole, 40 g/L benzovindiflupyr
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Elatus Ace Solatenol brand fungicide’ to ‘Elatus Ace Solatenol Active Fungicide’
Date of variation: 11 March 2020
Product registration no.: 86310
Label approval no.: 86310/124441
Application no.: 124450
Product name: Nufarm Kaiso 240EG Insecticide with Sorbie Technology
Active constituent/s: 240 g/kg lambda-cyhalothrin
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Kaiso 240EG Insecticide’ to ‘Nufarm Kaiso 240EG Insecticide with Sorbie Technology’
Date of variation: 12 March 2020
Product registration no.: 83077
Label approval no.: 83077/124450
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 8
Agricultural Chemical Products and Approved Labels
Application no.: 124479
Product name: Durango Herbicide
Active constituent/s: 360 g/L glyphosate present as the isopropylamine and mono-ammonium salts
Applicant name: Production Agriscience (Australia) Pty Ltd
Applicant ACN: 616 181 769
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Dupont Glyphosate Herbicide’ to ‘Durango Herbicide’
Date of variation: 13 March 2020
Product registration no.: 80641
Label approval no.: 80641/124479
Application no.: 123452
Product name: Ozcrop Dicamba 500 SL Herbicide
Active constituent/s: 500 g/L dicamba present as the dimethylamine salt
Applicant name: Ozcrop Pty Ltd
Applicant ACN: 160 656 431
Summary of variation: To add use in pine plantations to encourage wood wasp attack and in rice to control dirty dora, sedges and starfruit
Date of variation: 17 March 2020
Product registration no.: 65603
Label approval no.: 65603/123452
Application no.: 119003
Product name: Eco-Oil Organic Miticide/Insecticide/Adjuvant Botanical Oil Concentrate
Active constituent/s: 850 g/L emulsifiable botanical oil
Applicant name: Duluxgroup (Australia) Pty Ltd
Applicant ACN: 000 049 427
Summary of variation: To add control of mealybugs and sooty mould in ornamentals and black scale in olives
Date of variation: 17 March 2020
Product registration no.: 85574
Label approval no.: 85574/119003
Application no.: 123584
Product name: Flowable Gesaprim 600 SC Liquid Herbicide
Active constituent/s: 600g/L atrazine
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of variation: To add use to control purple top verbena in tea tree plantations
Date of variation: 18 March 2020
Product registration no.: 53892
Label approval no.: 53892/123584
Application no.: 121936
Product name: Zulu XT Herbicide
Active constituent/s: 720 g/L 2,4-D present as isopropylamine and dimethylamine salts
Applicant name: Adama Australia Pty Limited
Applicant ACN: 050 328 973
Summary of variation: To add additional application methods for the control of fleabane, sowthistle and yellow vine in fallow situations and to make minor amendments to the direction for use
Date of variation: 18 March 2020
Product registration no.: 83244
Label approval no.: 83244/121936
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 9
Agricultural Chemical Products and Approved Labels
Application no.: 121771
Product name: Virkon S The Broad Spectrum Virucidal Bactericidal Fungicidal Disinfectant
Active constituent/s: 494 g/kg potassium peroxomonosulfate triple salt, 132 g/kg sodium dodecyl benzene sulfonate, 15 g/kg sodium chloride
Applicant name: Alltech Lienert Australia Pty Ltd
Applicant ACN: 008 293 007
Summary of variation: To add special cases of approved uses in horticulture and in agricultural buildings and general farm equipment
Date of variation: 23 March 2020
Product registration no.: 48185
Label approval no.: 48185/121771
Application no.: 122049
Product name: Talinor Herbicide
Active constituent/s: 175 g/L bromoxynil present as the octanoate, 37.5 g/L bicyclopyrone, 9.4 g/L cloquintocet -mexyl
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of variation: To include the control of matracia/Globe Chamomile and suppression of statice in wheat and barley
Date of variation: 23 March 2020
Product registration no.: 82256
Label approval no.: 82256/122049
Application no.: 123583
Product name: Gesaprim Granules Herbicide
Active constituent/s: 900 g/kg atrazine
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of variation: To add use to control purple top verbena in tea tree plantations
Date of variation: 25 March 2020
Product registration no.: 61892
Label approval no.: 61892/123583
Application no.: 121682
Product name: Yanco Mosquito Coils
Active constituent/s: 2.5 g/kg pyrethrins
Applicant name: Yanco Limited
Applicant ACN: N/A
Summary of variation: To register an additional formulation
Date of variation: 25 March 2020
Product registration no.: 87731
Label approval no.: 87731/121682
Application no.: 123681
Product name: Accensi Atrazine 900 WG Herbicide
Active constituent/s: 900 g/kg atrazine
Applicant name: Accensi Pty Ltd
Applicant ACN: 079 875 184
Summary of variation: To add use to control purple top verbena in tea tree plantations
Date of variation: 26 March 2020
Product registration no.: 55093
Label approval no.: 55093/123681
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 10
Agricultural Chemical Products and Approved Labels
Application no.: 120185
Product name: Bird Free Bird Deterrent
Active constituent/s: 720 g/kg polybutene, 5.3 g/kg peppermint oil
Applicant name: Bird Free Australia Pty Ltd
Applicant ACN: 622 083 470
Summary of variation: For deterring starlings and mynahs
Date of variation: 27 March 2020
Product registration no.: 85617
Label approval no.: 85617/120185
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 11
Veterinary Chemical Products and Approved Labels
Veterinary Chemical Products and Approved Labels
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals
Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of
the registration in respect of the following products and has approved the label or varied the relevant particulars or
conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.: 123560
Product name: Neovexx Injectable Solution
Active constituent/s: 100 mg/mL tulathromycin
Applicant name: Neove Pharma Australia Pty Limited
Applicant ACN: 140 367 442
Summary of use: For the registration of an injectable solution product for the treatment of respiratory infections in cattle and pigs
Date of registration: 23 March 2020
Product registration no.: 89089
Label approval no.: 89089/123560
Application no.: 118074
Product name: Baycox Iron Suspension Injection for Pigs
Active constituent/s: 487.7 mg/mL iron gleptoferron (equivalent to 182 mg/mL iron), 36.4 mg/mL toltrazuril
Applicant name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of use: For the control of coccidiosis and prevention of iron deficiency anaemia in piglets
Date of registration: 26 March 2020
Product registration no.: 87308
Label approval no.: 87308/118074
Application no.: 116234
Product name: Elanco Flubenol Oral Wormer For Pigs And Chickens
Active constituent/s: 50 mg/g flubendazole
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of use: For aid in the control of sensitive strains of the following internal parasites: gastrointestinal worms (Ascaridia galli, Heterakis gallinarum, Capillaria spp., Raillietina spp. ) in chickens and gastrointestinal worms (Ascaris suum, Hyostrongylus rubidis, Oesophagostomum dentatum) and lungworm (Metastrongylus apri) in pigs
Date of registration: 27 March 2020
Product registration no.: 86633
Label approval no.: 86633/116234
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 12
Veterinary Chemical Products and Approved Labels
2. VARIATIONS OF REGISTRATION
Application no.: 121582
Product name: Multimin Copper-Free Injection For Sheep And Cattle
Active constituent/s: 40 g/L zinc as zinc disodium EDTA, 10 g/L manganese as disodium manganese EDTA, 5 g/L selenium as sodium selenite
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 77 003 268 871
Summary of variation: To vary the product claims and label approval
Date of variation: 23 March 2020
Product registration no.: 61724
Label approval no.: 61724/121582
Application no.: 121628
Product name: Multimin Plus Copper Injection For Sheep
Active constituent/s: 40 g/L zinc as disodium zinc EDTA, 10 g/L copper as disodium copper EDTA,10 g/L manganese as disodium manganese EDTA, 3 g/L selenium as sodium selenite
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 77 003 268 871
Summary of variation: To vary the product claims and label approval
Date of variation: 24 March 2020
Product registration no.: 83674
Label approval no.: 83674/121628
3. VARIATION OF LABEL APPROVAL
Application no.: 124241
Product name: Avensin 400 Monensin Feed Additive Premix
Active constituent/s: 400 g/kg monensin as monensin sodium
Applicant name: Phibro Animal Health Pty Limited
Applicant ACN: 093 869 991
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Phibromonensin 400 Monensin Feed Additive Premix’ to ‘Avensin 400 Monensin Feed Additive Premix’
Date of variation: 27 February 2020
Product registration no.: 55527
Label approval no.: 55527/124241
Application no.: 121704
Product name: Strikeforce-S Spray-On Sheep Blowfly Treatment
Active constituent/s: 50 g/L dicyclanil
Applicant name: Jurox Pty Limited
Applicant ACN: 000 932 230
Summary of variation: To update label safety instructions
Date of variation: 17 March 2020
Product registration no.: 81483
Label approval no.: 81483/121704
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 13
Veterinary Chemical Products and Approved Labels
Application no.: 123630
Product name: Elanco AF1375 Maxiban Narasin/Nicarbazin Anticoccidial Premix
Active constituent/s: 80 g/kg narasin, 80 g/kg nicarbazin
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation: To update product label in line with current label guidelines
Date of variation: 24 March 2020
Product registration no.: 36802
Label approval no.: 36802/123630
Application no.: 123862
Product name: Elanco AF0510 Monteban 100 Narasin Premix
Active constituent/s: 100 g/kg narasin
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation: Variation of product label approval to update the RLP according to the current label guidelines
Date of variation: 24 March 2020
Product registration no.: 36784
Label approval no.: 36784/123862
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 14
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.: 119924
Active constituent/s: Captan
Applicant name: Krishi Rasayan Exports Pvt Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 23 March 2020
Approval no.: 87968
Application no.: 122120
Active constituent/s: Tylosin tartrate
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of use: For use in veterinary chemical products only
Date of approval: 24 March 2020
Approval no.: 88735
Application no.: 120027
Active constituent/s: Dicamba
Applicant name: Monsanto Australia Pty Ltd
Applicant ACN: 006 725 560
Summary of use: For use in agricultural chemical products
Date of approval: 30 March 2020
Approval no.: 88007
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 15
New agricultural active constituent: trifludimoxazin
New agricultural active constituent: trifludimoxazin
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has an application for the approval of a new
agricultural active constituent, trifludimoxazin, for use as a herbicide.
Common name: Trifludimoxazin (ISO)
IUPAC name: 1,5-Dimethyl-6-thioxo-3-[2,2,7-trifluoro-3-oxo-4-(prop-2-yn-1-yl)-3,4-dihydro-2H-1,4-
benzoxazin-6-yl]-1,3,5-triazinane-2,4-dione
Chemical abstracts name: Dihydro-1,5-dimethyl-6-thioxo-3-[2,2,7-trifluoro-3,4-dihydro-3-oxo-4-(2-propyn-1-yl)-
2H-1,4-benzoxazin-6-yl]-1,3,5-triazine-2,4(1H,3H)-dione
CAS number: 1258836-72-4
Molecular formula: C16H11F3N4O4S
Molecular weight: 412.3 gmol-1
Structure:
Chemical family: Triazinone
Mode of action: Protoporphyrinogen oxidase inhibitor
SUMMARY OF THE APVMA’S EVALUATION
The APVMA has evaluated the chemistry aspects of trifludimoxazin active constituent (identification, stability,
physicochemical properties, manufacturing process, specifications, quality control procedures, batch analysis results and
analytical methods) and found them to be acceptable.
Impurities of toxicological significance are not expected to occur in trifludimoxazin as a result of the raw materials and the
synthetic route used.
The APVMA has considered the toxicological aspects of trifludimoxazin, and concluded that there are no toxicological
concerns regarding the approval of this active constituent. An Acceptable Daily Intake (ADI) of 0.1 mg/kg bw/d has been
established. There were no acute toxicological effects indicative of a need to establish an Acute Reference Dose (ARfD).
After consideration of recommendations by the Advisory Committee on Chemical Scheduling, the Scheduling Delegate
made a final decision to include trifludimoxazin in Schedule 5 of the Standard for the Uniform Scheduling of Medicines
and Poisons, with a cut-off to being unscheduled when in formulations at 12.5 per cent or less, and with an
implementation date of 1 February 2020.
The APVMA is satisfied that the proposed use of trifludimoxazin would not be an undue toxicological hazard to the safety
of people exposed to it during its handling and use.
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 16
New agricultural active constituent: trifludimoxazin
MAKING A SUBMISSION
In accordance with section 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission
as to whether the application for approval of trifludimoxazin should be granted. Submissions should relate only to matters
that are considered in determining whether the safety criteria set out in section 5A of the Agvet Code have been met.
Submissions should state the grounds on which they are based.
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact
listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.
When making a submission please include a:
contact name
company or group name (if relevant)
email or postal address (if available)
the date you made the submission.
All personal and confidential commercial information (CCI)1 material contained in submissions will be treated
confidentially.
Written submissions should be addressed in writing to:
Director of Chemistry and Manufacture
Risk Assessment Capability
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2300
Email: [email protected]
1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 17
New chemical product Voraxor Herbicide containing trifludimoxazin and saflufenacil
New chemical product Voraxor Herbicide containing trifludimoxazin and saflufenacil
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for registration of a
new product containing, Voraxor Herbicide a new active constituent trifludimoxazin and an approved active constituent
saflufenacil.
PARTICULARS OF THE APPLICATION
Proposed product name: Voraxor Herbicide
Applicant company: BASF Australia Pty Ltd
Name of active constituents: Trifludimoxazin, saflufenacil
Signal heading: Schedule 5
Summary of proposed use: For control of weeds in a variety of situations
Pack sizes: 5–110 L
Withholding period: Harvest: not required when used as directed
Grazing: do not graze or cut for stock food for 6 weeks after application
Do not allow livestock to graze treated weeds
SUMMARY OF THE APVMA’S EVALUATION OF VORAXOR HERBICIDE IN ACCORDANCE WITH THE
REQUIREMENTS OF SECTION 14(1)(C) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (THE
‘AGVET CODE’), SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994
1. The APVMA has evaluated the application and in its assessment in relation to whether the safety criteria have been met
in accordance with the definition set out in section 5A of the Agvet Code, and proposes to determine that:
(i) The APVMA is satisfied that the proposed use of Voraxor Herbicide containing the active constituents
trifludimoxazin and saflufenacil would not be an undue hazard to the safety of people exposed to it during its
handling and use.
(ii) The APVMA is satisfied that the proposed use of Voraxor Herbicide containing the active constituents
trifludimoxazin and saflufenacil will not be an undue hazard to the safety of people using anything containing its
residues.
(iii) The APVMA is satisfied that the proposed use of Voraxor Herbicide containing the active constituents
trifludimoxazin and saflufenacil is not likely to be harmful to human beings if used according to the product label
directions.
(iv) The APVMA is satisfied that the proposed use of the new products Voraxor Herbicide containing the active
constituents trifludimoxazin and saflufenacil, would not be likely to have an unintended effect that is harmful to
animals, plants or things or the environment.
2. The APVMA has evaluated the application and in its assessment in relation to whether the efficacy criteria have been
met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 18
New chemical product Voraxor Herbicide containing trifludimoxazin and saflufenacil
(i) In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials
supporting the efficacy of the product adequately demonstrate that if used according to the product label directions,
the product is effective for its proposed uses.
3. The APVMA has evaluated the application and in its assessment in relation to whether the trade criteria have been met
in accordance with the definition set out in section 5C of the Agvet Code, and proposes to determine that:
(ii) The APVMA is satisfied that the proposed use of Voraxor Herbicide would not adversely affect trade between
Australia and places outside Australia as the product is not for use in animals producing any major Australian
export commodities.
FURTHER INFORMATION
A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Public
Consultation’ page, or by contacting the evaluator listed below.
MAKING A SUBMISSION
In accordance with section13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission
as to whether Voraxor Herbicide should be registered. Submissions should relate only to matters that are required by the
APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have been met.
Submissions should state the grounds on which they are based.
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact
listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.
Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and
in determining appropriate conditions of registration and product labelling.
When making a submission please include a:
contact name
company or group name (if relevant)
email or postal address (if available)
the date you made the submission.
All personal and confidential commercial information (CCI)2 material contained in submissions will be treated
confidentially.
Written submissions should be addressed in writing to:
Case Management and Administration Unit
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2300
Email: [email protected]
2 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 19
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. 3) 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]
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 20
Proposal to amend Schedule 20 of 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 19 of APVMA Gazette No. 7, 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. 3) 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 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 21
Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code
PROPOSED VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE
(31 March 2020)
Note: Subsection 82(2) of the Food Standards Australia New Zealand Act 1991 provides that variations to standards
are legislative instruments, but are not subject to disallowance or sunsetting.
To commence: on gazettal of variation
[1] The table to section S20–3 in Schedule 20 is varied by
[1.1] inserting in alphabetical order
Agvet chemical: tetraniliprole
Permitted residue: tetraniliprole
Almonds 0.05
Apricots, dried 3
Banana *0.01
Cherries 1
Edible offal (mammalian) 0.02
Eggs *0.01
Macadamia nuts *0.01
Milks *0.01
Pome fruits 0.5
Poultry, edible offal of *0.01
Poultry meat *0.01
Prunes 3
Stone fruits (except cherries) 0.7
Agvet chemical: trifludimoxazin
Permitted residue: trifludimoxazin
Barley *0.01
Edible offal (mammalian) *0.01
Eggs *0.01
Meat (mammalian) *0.01
Milks *0.001
Poultry, edible offal of *0.01
Poultry meat *0.01
Wheat *0.01
[1.2] omitting from each of the following chemicals, the foods and associated MRLs
Agvet chemical: chlorantraniliprole
Permitted residue—plant commodities and animal commodities other than milk: chlorantraniliprole
Permitted residue—milk: sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliprole
Almonds 0.1
Pistachio nut T0.05
Root and tuber vegetables T0.05
Walnuts T0.05
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 22
Proposal to amend 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: chlorantraniliprole
Permitted residue—plant commodities and animal commodities other than milk: chlorantraniliprole
Permitted residue—milk: sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliprole
Potato *0.01
Root and tuber vegetables (except potato)
T0.5
Tree nuts 0.1
Agvet chemical: methomyl
Permitted residue: methomyl
Brassica leafy vegetables T0.7
Fennel, bulb T0.2
Fennel, leaf T3
Leek T0.5
Onion, bulb T0.1
Spinach T0.7
Agvet chemical: spinetoram
Permitted residue: sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L
Maize cereals T*0.01
Olives for oil production T0.07
Onion, bulb T*0.01
Sorghum grains and millet T*0.01
Table olives T0.07
[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
Assorted tropical and sub-tropical fruits—inedible peel (except banana; pineapple)
2
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 23
Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code
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
Assorted tropical and sub-tropical fruits—inedible peel (except banana; pineapple)
2
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 24
Proposal to amend Schedule 20 of 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) 5 May 2020.
Submissions received after this date will only be considered if agreement for an extension has been given prior to this
closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to
the submission period.
For further information please contact:
MRL Contact Officer
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2401
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 25
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 14 January 2020 (No. APVMA 1).
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
3, 2020) accompanies this notice. For a complete and up-to-date version of Schedule 20, including these amendments
together with their Explanatory Statement, please refer to the Federal Register of Legislation available on the Legislation
website.
Based on dietary exposure assessments and current health standards, the APVMA and Food Standards Australia and
New Zealand (FSANZ) are satisfied that these MRLs are not harmful to public health. MRLs contained in Schedule 20
provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this
means, Schedule 20 permits the sale of treated foods and protects public health by minimising residues in foods
consistent with the effective control of pests and diseases.
The agreement between the Australian Government and the New Zealand Government concerning a Joint Food
Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food
standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary
chemicals in food.
Food Standards Australia New Zealand (FSANZ) made Sanitary and Phytosanitary (SPS) notification to the World Trade
Organization (WTO) in relation to these variations and no comment was received in response to that notice.
A copy of these variations have been given to FSANZ.
The variations take effect as from the date of this notice.
This notice is published in accordance with subsection 82(7) of the Food Standards Australia New Zealand Act 1991.
For further information please contact:
MRL Contact Officer
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2383
Email: [email protected]
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 3, 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 Thirty first day of March 2020
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 27
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 3, 2020.
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 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 28
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: bixlozone
Permitted residue: bixlozone
Barley *0.01
Edible offal (mammalian) *0.01
Eggs *0.01
Meat (mammalian) *0.01
Milks *0.01
Poultry, edible offal of *0.01
Poultry meat *0.01
Rape seed (canola) *0.01
Wheat *0.01
Agvet chemical: carbetamide
Permitted residue: carbetamide
Edible offal (mammalian) *0.05
Eggs *0.05
Meat (mammalian) *0.05
Milks *0.05
Poultry, edible offal of *0.05
Poultry meat *0.05
Pulses *0.01
Agvet chemical: flubendazole
Permitted residue—commodities other than eggs:
sum of flubendazole and 2-amino-1 H-benzimidazole-5-yl)(4-fluorophenyl methanone, expressed as flubendazole
Permitted residue—eggs: flubendazole
Chicken fat/skin 0.03
Chicken liver 0.2
Chicken kidney 0.1
Chicken muscle *0.02
Eggs 0.6
Pig fat/skin *0.02
Pig liver 0.4
Pig kidney 0.3
Pig muscle *0.02
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 29
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
[1.2] omitting from each of the following chemicals, the foods and associated MRLs
Agvet chemical: lasalocid
Permitted residue: lasalocid
Poultry, edible offal of 0.4
Poultry meat 0.7
[1.3] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order
Agvet chemical: diafenthiuron
Permitted residue: sum of diafenthiuron; N-[2,6-bis(1-methylethyl)- 4-phenoxyphenyl]-N′-(1,1-dimethylethyl)urea; and N-[2,6-bis(1-methylethyl)-4-phenoxyphenyl]-N′-(1,1-dimethylethyl)carbodiimide, expressed as diafenthiuron
Fruiting vegetables, cucurbits 0.5
Fruiting vegetables, other than cucurbits 0.5
Agvet chemical: difenoconazole
Permitted residue: difenoconazole
Coffee beans T*0.01
Agvet chemical: etoxazole
Permitted residue: etoxazole
Sweet corn (kernels) 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
Assorted tropical and sub-tropical fruits—inedible peel (except banana; pineapple)
T2
Agvet chemical: fluralaner
Permitted residue: fluralaner
Chicken eggs 1.3
Chicken fat/skin 0.6
Chicken kidney 0.4
Chicken liver 0.6
Chicken muscle 0.06
Agvet chemical: halosulfuron-methyl
Permitted residue: halosulfuron-methyl
Soya bean (dry) T*0.01
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 30
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Agvet chemical: imazamox
Permitted residue: imazamox
Eggs *0.01
Poultry meat *0.01
Poultry, edible offal of *0.01
Agvet chemical: lasalocid
Permitted residue: lasalocid
Poultry kidney 0.7
Poultry liver 1.2
Poultry muscle 0.4
Agvet chemical: napropamide
Permitted residue: napropamide
Basil T*0.1
Agvet chemical: prosulfocarb
Permitted residue: prosulfocarb
Safflower seed T*0.1
Agvet chemical: tebuconazole
Permitted residue: tebuconazole
Coffee bean T0.1
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
Assorted tropical and sub-tropical fruits—inedible peel (except banana; pineapple)
T2
[1.4] omitting for each of the following chemicals, the maximum residue limit for the food and substituting
Agvet chemical: bifenthrin
Permitted residue: bifenthrin
Sugar cane T0.7
Agvet chemical: glufosinate and glufosinate-ammonium
Permitted residue: sum of glufosinate-ammonium, N-acetyl glufosinate and 3-[hydroxy(methyl)-phosphinoyl] propionic acid, expressed as glufosinate (free acid)
Podded pea (young pods) (snow and sugar snap)
T*0.05
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 31
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Agvet chemical: lasalocid
Permitted residue: lasalocid
Poultry fat/skin 0.6
Agvet chemical: oxamyl
Permitted residue: sum of oxamyl and 2-hydroxyimino-N,N-dimethyl-2-(methylthio)-acetamide, expressed as oxamyl
Sweet potato 0.2
Agvet chemical: trinexapac-ethyl
Permitted residue: trinexapac acid
Poppy seed 20
Sugar cane 0.1
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 32
Consultation on use patterns for anticoagulant rodenticide products
Consultation on use patterns for anticoagulant rodenticide products
CONSULTATION PERIOD ENDS 3 JULY 2020.
KEY ISSUES
1. Products considered anticoagulant rodenticides have been prioritised for reconsideration on the basis of concerns
for worker exposure, public health and environmental safety.
2. The use of products in domestic premises, animal production facilities and food production facilities is currently
allowed.
3. International jurisdictions (including the United States Environmental Protection Agency and the European
Chemicals Agency) have taken action to limit access to these products by non-professional users, and to restrict the
product formulations available and the situations in which these products may be used.
4. The APVMA is consulting with the states and territories and relevant holders regarding the registered particulars and
conditions of use for anticoagulant rodenticide products. This does not include the intentional misuse of the products,
not in accordance with the label instructions.
FOCUS OF THE CONSULTATION
Registered products containing the following active constituents are included in this consultation:
First-generation anticoagulant rodenticides (FGARs):
warfarin
coumatetralyl
diphacinone
Second-generation anticoagulant rodenticides (SGARs):
brodifacoum
bromadiolone
difenacoum
difethialone
flocoumafen
CONSIDERATIONS
5. During this consultation, the APVMA welcomes submissions on matters related to:
a) The need for anticoagulant rodenticide products to be used in home garden or domestic settings;
b) The need for anticoagulant rodenticide products to be used in residential or suburban settings, for example, for
public health or public sanitation programs;
c) The need for anticoagulant rodenticide products to be used in or around buildings, including those used to house
livestock, or in or around on-farm buildings (including homesteads);
d) The need for anticoagulant rodenticide products to be formulated as powders, gels, liquids, pellets, grains or pastes;
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 33
Consultation on use patterns for anticoagulant rodenticide products
e) The likelihood of compliance with post-application sanitisation instruction (eg the timely collection of poisoned rodent
carcasses, and the appropriate disposal of carcasses);
f) The label instructions, particularly the adequacy of instructions to prevent inadvertent exposure to the product;
g) Critical uses for anticoagulant rodenticide products, particularly in primary production; and,
h) Other relevant matters related to the use of anticoagulant rodenticide products.
WRITTEN SUBMISSIONS ARE INVITED
6. The deadline for submissions is 3 July 2020. Electronic submissions are preferred, and submissions with an email
address will be acknowledged electronically.
7. Note that all submissions received are subject to legislation, including the Freedom of Information Act 1982,
the Privacy Act 1988 and the Agvet Codes. In providing your submission to the APVMA, you agree to the APVMA
publicly disclosing your submission in whole or summary form. Submissions should not contain confidential
commercial information.
APVMA CONTACT
Questions and submissions should be directed to:
Chemical Review
Office of the Chief Regulatory Scientist
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2400
Email: [email protected]