Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
No. APVMA 17, Tuesday, 28 August 2012
Published by The Australian Pesticides & Veterinary Medicines Authority
AGRICULTURAL AND
VETERINARY CHEMICALS
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 Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 2
Commonwealth of Australia 2012
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:
The Manager, Public Affairs
The Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Email: [email protected]
Website: www.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 a s required
by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material
issued by the APVMA.
Pursuant to section 53(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publi sh details of applications
made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activ ity in
quarterly statistical reports.
DISTRIBUTION AND SUBSCRIPTION
From February 2010, the APVMA will publish the APVMA Gazette in electronic format only. The APVMA Gazette and information
about subscribing to the gazette alert service are available on the APVMA website, www.apvma.gov.au.
Copies of the APVMA Gazette from November 1999 until July 2009 will remain available from the APVMA website.
APVMA CONTACTS
For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4870
For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Notice of Registrations 4 Agricultural Chemical Products .............................................................................................................................................. 4 Veterinary Chemical Products .............................................................................................................................................. 20
Notice – New Agricultural Active Constituent 23 Penthiopyrad ........................................................................................................................................................................ 23
Notice – New Agricultural Chemical Products 26 Penthiopyrad in the product DuPont™ Fontelis® Fungicide ................................................................................................ 26
Notice – New Veterinary Chemical Products 30 Dexmedetomidine hydrochloride in the product Dexdomitor Injectable Sedative and Analgesic for Dogs and Cats ............ 30
Other Notices 33 Cancellation of Active Constituent Approvals at the Request of the Approval Holder .......................................................... 33 Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code ............................................................. 34 Addendum to the Record of Approved Active Constituents .................................................................................................. 40 Application Summaries ......................................................................................................................................................... 41
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 4
Notice of Registrations – Agricultural Chemical Products
NOTICE OF REGISTRATIONS
Agricultural Chemical Products
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 registration in respect of the following
products, with effect from the dates shown.
1. RESTRICTED PRODUCT
Product Name: Homeguard Termiflex Termiticidal Adhesive & Sealant
Active Constituent/s: 2g/kg bifenthrin
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For the management of subterranean termites (except Mastotermes darwiniensis)
Date of Registration: 17 August 2012
Label Approval No: 58471/50039
2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Titan Terbutryn 500 SC Herbicide
Active Constituent/s: 500g/L terbutryn
Applicant Name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of Use: For the control of certain early competing broadleaf weeds in wheat, barley, triticale, pastures, some varieties of oats and field peas
Date of Registration: 2 August 2012
Label Approval No: 67767/56821
Product Name: Ratsak Professional All Weather Wax Blocks
Active Constituent/s: 0.05g/kg brodifacoum
Applicant Name: Duluxgroup (Australia) Pty Ltd
Applicant ACN: 000 049 427
Summary of Use: For the control of rats and mice in and around agricultural, industrial, commercial and domestic buildings
Date of Registration: 7 August 2012
Label Approval No: 67611/56454
Product Name: Coles Stabilised Granular Chlorine
Active Constituent/s: 560g/kg available (Cl) chlorine present as sodium dichloroisocyanurate
Applicant Name: Hy-Clor (Australia) Pty Ltd
Applicant ACN: 000 655 381
Summary of Use: For use in swimming pools for the control of bacteria and algae
Date of Registration: 8 August 2012
Label Approval No: 67659/56559
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 5
Notice of Registrations – Agricultural Chemical Products
Product Name: Marque Stabilised Granular Chlorine
Active Constituent/s: 560g/kg available chlorine (Cl) present as sodium dichloroisocyanurate
Applicant Name: Hy-Clor (Australia) Pty Ltd
Applicant ACN: 000 655 381
Summary of Use: For the control of algae and bacteria in swimming pools
Date of Registration: 8 August 2012
Label Approval No: 67661/56564
Product Name: Ezycrop Triadimefon 500 WG Fungicide
Active Constituent/s: 500g/kg triadimefon
Applicant Name: Ezycrop Pty Ltd
Applicant ACN: 156 476 827
Summary of Use: For the control of fungal diseases of wheat and barley
Date of Registration: 8 August 2012
Label Approval No: 67793/56885
Product Name: Novaguard Imidacloprid 200 SC Insecticide
Active Constituent/s: 200g/L imidacloprid
Applicant Name: Novaguard Pty Ltd
Applicant ACN: 153 121 156
Summary of Use: For the control of various insect pests of certain vegetables and turf
Date of Registration: 8 August 2012
Label Approval No: 67593/56422
Product Name: AW Powerfen 100SC Termiticide And Insecticide
Active Constituent/s: 100g/L bifenthrin.
Applicant Name: Agri West Pty Limited
Applicant ACN: 108 899 181
Summary of Use: For the control of a range of urban interior and exterior pests, for protection of structures from subterranean termite damage and for the control of termites
Date of Registration: 8 August 2012
Label Approval No: 67572/56369
Product Name: Farmalinx Thundercat 700 WG Herbicide
Active Constituent/s: 700g/kg imazethapyr
Applicant Name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of Use: For the control of certain weeds in Centrosema (Cavalcade), chickpeas, faba beans, field peas, lucerne, mung beans, peanuts, serradella, soybeans and subterranean clover
Date of Registration: 9 August 2012
Label Approval No: 67752/56794
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 6
Notice of Registrations – Agricultural Chemical Products
Product Name: Terminade Residual Termiticide
Active Constituent/s: 100g/L fipronil
Applicant Name: PCT Holdings Pty Ltd
Applicant ACN: 099 023 962
Summary of Use: For the control of subterranean termites
Date of Registration: 9 August 2012
Label Approval No: 63502/45817
Product Name: Kenso Agcare Ken-Mide 500 WG Herbicide
Active Constituent/s: 500g/kg propyzamide
Applicant Name: Kenso Corporation (M) Sdn. Bhd.
Applicant ACN: N/A
Summary of Use: For selective control of certain grasses and broad leaf weeds in lettuce, sports turf, home lawns and legume seed crops and pastures
Date of Registration: 9 August 2012
Label Approval No: 67262/55648
Product Name: Proterra Metolachlor 960 Herbicide
Active Constituent/s: 960g/L metolachlor
Applicant Name: Proterra Pty Ltd
Applicant ACN: 120 507 182
Summary of Use: For the control of certain annual grasses and broadleaf weeds in certain crops
Date of Registration: 9 August 2012
Label Approval No: 67788/56873
Product Name: Genfarm Epoxiconazole 125 Fungicide
Active Constituent/s: 125g/L epoxiconazole
Applicant Name: Landmark Operations Limited
Applicant ACN: 008 743 217
Summary of Use: For the control of leaf rust, stripe rust and Septoria nodorum blotch of wheat and rust of barley
Date of Registration: 9 August 2012
Label Approval No: 66316/53370
Product Name: Predator 300 Insecticide
Active Constituent/s: 300g/L chlorpyrifos (an anticholinesterase compound)
Applicant Name: Dow Agrosciences Australia Limited
Applicant ACN: 003 771 659
Summary of Use: For the control of Helicoverpa spp., mites, aphids and other insect pests of cotton
Date of Registration: 10 August 2012
Label Approval No: 67915/57067
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 7
Notice of Registrations – Agricultural Chemical Products
Product Name: Superway Bifenthrin 100SC Water-Based Termiticide & Insecticide
Active Constituent/s: 100g/L bifenthrin
Applicant Name: Superway Garden Ag & Pest Products Pty Ltd
Applicant ACN: 056 553 274
Summary of Use: For the pre and post-construction management of subterranean termites in accord with AS 3660 and for the control of termites and a range of interior and exterior urban pests
Date of Registration: 10 August 2012
Label Approval No: 67896/57042
Product Name: Titan Azoxystrobin 250SC Fungicide
Active Constituent/s: 250g/L azoxystrobin
Applicant Name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of Use: For the control of various diseases of grapes, potatoes, tomatoes, cucurbits, avocadoes, mangoes, passionfruit and poppies
Date of Registration: 10 August 2012
Label Approval No: 67421/56001
Product Name: Fasten Spray Adjuvant
Active Constituent/s: 700g/L ethyl and methyl esters of vegetable oil with 116g/L non-ionic surfactants
Applicant Name: Agrobest IP Pty Ltd
Applicant ACN: 128 029 701
Summary of Use: To assist in the effectiveness of herbicides and other agricultural chemicals
Date of Registration: 10 August 2012
Label Approval No: 67800/56894
Product Name: Yates Easy See Spray Dye Liquid Spray Marker Dye
Active Constituent/s: 90g/L sulphonated aromatic acid dye
Applicant Name: Duluxgroup (Australia) Pty Ltd
Applicant ACN: 000 049 427
Summary of Use: For use with herbicide and pesticide spray solutions in the home garden
Date of Registration: 10 August 2012
Label Approval No: 67275/55672
Product Name: Agrobest Ammonium Sulphate 417
Active Constituent/s: 417g/L ammonium sulphate
Applicant Name: Agrobest IP Pty Ltd
Applicant ACN: 128 029 701
Summary of Use: For use with glyphosate based herbicides to minimise antagonism when tank mixing with flowable herbicides and improve performance under adverse environmental conditions
Date of Registration: 13 August 2012
Label Approval No: 67790/56881
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 8
Notice of Registrations – Agricultural Chemical Products
Product Name: 4Farmers Tribenuron Methyl 750 Herbicide
Active Constituent/s: 750g/kg tribenuron methyl
Applicant Name: 4 Farmers Pty Ltd
Applicant ACN: 067 443 485
Summary of Use: For the control of certain broadleaf weeds in fallow and pre-crop situations
Date of Registration: 13 August 2012
Label Approval No: 65952/52377
Product Name: Repel Mosquito Coils
Active Constituent/s: 4g/kg d-allethrin
Applicant Name: Mayo Hardware Pty Ltd
Applicant ACN: 071 517 176
Summary of Use: For the control of mosquitoes in the domestic environment
Date of Registration: 13 August 2012
Label Approval No: 67472/56132
Product Name: AFA Upside Spray Oil Adjuvant
Active Constituent/s: 582g/L paraffinic oil, 120g/L nonyl phenol ethoxylate, 120g/L alcohol ethoxylate
Applicant Name: Agricultural Formulators Australia Pty Ltd
Applicant ACN: 146 039 661
Summary of Use: For use as an adjuvant to improve the spreading and wetting of herbicides, insecticides, and defoliants on plant surfaces
Date of Registration: 13 August 2012
Label Approval No: 67851/56964
Product Name: Atlas Flying Insect Killer Low Allergenic Odourless
Active Constituent/s: 2.09g/kg bioallethrin, 0.39g/kg bioresmethrin
Applicant Name: Pascoe's Pty Ltd
Applicant ACN: 055 220 463
Summary of Use: For insect control in and around the home
Date of Registration: 13 August 2012
Label Approval No: 67852/56965
Product Name: AFA Amsul Adjuvant
Active Constituent/s: 417g/L ammonium sulphate
Applicant Name: Agricultural Formulators Australia Pty Ltd
Applicant ACN: 146 039 661
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: 13 August 2012
Label Approval No: 67847/56953
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 9
Notice of Registrations – Agricultural Chemical Products
Product Name: Rainbow Chlorothalonil 900 WG Fungicide
Active Constituent/s: 900g/kg chlorothalonil
Applicant Name: Shandong Rainbow International Co., Ltd.
Applicant ACN: N/A
Summary of Use: For the control of fungal diseases on almonds, apricots, bananas, carrots, celery, cherries, faba beans, grapes, onions, peaches, peanuts, peas, plums, potatoes, tomatoes and vegetables
Date of Registration: 13 August 2012
Label Approval No: 67756/56801
Product Name: FMC Glyphosate 540 K Herbicide
Active Constituent/s: 540g/L glyphosate present as the potassium salt
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For the control of many annual and perennial weeds
Date of Registration: 13 August 2012
Label Approval No: 67830/56930
Product Name: Proterra Thidiazuron 500 Cotton Defoliant
Active Constituent/s: 500g/L thidiazuron
Applicant Name: Proterra Pty Ltd
Applicant ACN: 120 507 182
Summary of Use: For the defoliation of cotton prior to harvest
Date of Registration: 13 August 2012
Label Approval No: 67865/57000
Product Name: Titan Epoxiconazole 125 SC Fungicide
Active Constituent/s: 125g/L epoxiconazole
Applicant Name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of Use: For the control of leaf rust and Septoria nodorum blotch of wheat and leaf rust of barley
Date of Registration: 14 August 2012
Label Approval No: 65491/56283
Product Name: Woolworths Select Insect Bomb
Active Constituent/s: 0.77g/kg fenoxycarb, 10g/kg permethrin
Applicant Name: Woolworths Ltd
Applicant ACN: 000 014 675
Summary of Use: For the control of insect infestations and prevention of reinfestations
Date of Registration: 14 August 2012
Label Approval No: 67825/56920
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 10
Notice of Registrations – Agricultural Chemical Products
Product Name: Black Flag Odourless Fly & Mosquito Killer
Active Constituent/s: 1.1g/kg esbiothrin, 0.5g/kg permethrin
Applicant Name: Reckitt Benckiser (Australia) Pty Limited
Applicant ACN: 003 274 655
Summary of Use: For control of flies, mosquitoes, moths, cockroaches, ants, fleas, silverfish and spiders
Date of Registration: 14 August 2012
Label Approval No: 67835/56935
Product Name: Enviromax Fipronil 100SC Termiticide & Insecticide
Active Constituent/s: 100g/L fipronil
Applicant Name: Enviromax Technologies Pty Ltd
Applicant ACN: 132 643 577
Summary of Use: For control of subterranean termites around domestic and commercial structures
Date of Registration: 14 August 2012
Label Approval No: 65307/53223
Product Name: Agrobest Wetter 1000
Active Constituent/s: 1000g/L nonionic alcohol ethoxylates
Applicant Name: Agrobest IP Pty Ltd
Applicant ACN: 128 029 701
Summary of Use: For the improvement of spray coverage when using agricultural chemicals
Date of Registration: 14 August 2012
Label Approval No: 67799/56893
Product Name: Mortein Naturgard Fly & Mosquito Killer Odourless
Active Constituent/s: 1.1g/kg esbiothrin, 0.5g/kg permethrin
Applicant Name: Reckitt Benckiser (Australia) Pty Limited
Applicant ACN: 003 274 655
Summary of Use: For control of flies, mosquitoes, moths, cockroaches, ants, fleas, silverfish and spiders
Date of Registration: 14 August 2012
Label Approval No: 67849/56960
Product Name: Agrobest Buffer 700 Surfactant
Active Constituent/s: 350g/L soyal phospholipids, 350g/L propionic acid
Applicant Name: Agrobest IP Pty Ltd
Applicant ACN: 128 029 701
Summary of Use: For use as an acidifying and penetrating surfactant, which reduces alkaline hydrolysis of dimethoate, assists with uptake of foliar fertilisers and assists in management of spray droplet size
Date of Registration: 15 August 2012
Label Approval No: 67791/56883
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 11
Notice of Registrations – Agricultural Chemical Products
Product Name: Intercept 480SL Turf Growth Regulator
Active Constituent/s: 480g/L ethephon (an anti-cholinesterase compound)
Applicant Name: Greenshed Pty Limited
Applicant ACN: 105 996 307
Summary of Use: For prevention of Poa annua seedhead emergence
Date of Registration: 15 August 2012
Label Approval No: 63628/46098
Product Name: Imtrade Metakill Snail & Slug Bait
Active Constituent/s: 50g/kg metaldehyde
Applicant Name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of Use: For use as a snail and slug bait
Date of Registration: 15 August 2012
Label Approval No: 64990/49795
Product Name: Tebuhex 430 SC Fungicide
Active Constituent/s: 430g/L tebuconazole
Applicant Name: Hextar Chemicals Pty Ltd
Applicant ACN: 114 525 709
Summary of Use: For the control of leaf spot and leaf speckle on bananas, rust, leaf spot and net blotch of peanuts, foliar diseases on cereal crops and other diseases on beans, peas, onions, pawpaw, pyrethrum, ryegrass and fescue seed crops
Date of Registration: 15 August 2012
Label Approval No: 67507/56220
Product Name: Brunnings Bindii & Clover Kill
Active Constituent/s: 150g/L MCPA, 25g/L dicamba (both present as dimethylamine salt)
Applicant Name: Brunnings Garden Products Pty Ltd
Applicant ACN: 050 655 760
Summary of Use: For selective control of broad leaf weeds in lawns
Date of Registration: 16 August 2012
Label Approval No: 67447/56050
Product Name: Melpat Copper Sulphate Molluscicide
Active Constituent/s: 250g/kg copper (Cu) present as copper sulphate pentahydrate
Applicant Name: Melpat International Pty Ltd
Applicant ACN: 066 067 507
Summary of Use: For the control of aquatic snails in rice paddies
Date of Registration: 16 August 2012
Label Approval No: 65532/51142
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 12
Notice of Registrations – Agricultural Chemical Products
Product Name: Omni Trichlor Blend Pool Sanitiser & Oxidiser
Active Constituent/s: 660g/kg available chlorine (Cl) present as trichloroisocyanuric acid
Applicant Name: Biolab Australia Pty Ltd
Applicant ACN: 005 878 017
Summary of Use: For control of bacteria and algae in swimming pools
Date of Registration: 16 August 2012
Label Approval No: 67745/56786
Product Name: Spalding Exocet 250 Herbicide
Active Constituent/s: 135g/L paraquat present as paraquat dichloride, 115g/L diquat present as diquat dibromide
Applicant Name: Spalding Holdings Pty. Ltd.
Applicant ACN: 010 155 852
Summary of Use: For the control of a wide range of grasses and broadleaf weeds
Date of Registration: 16 August 2012
Label Approval No: 67891/57038
Product Name: Ezycrop Chlorsulfuron 750 WG Herbicide
Active Constituent/s: 750g/kg chlorsulfuron
Applicant Name: Ezycrop Pty Ltd
Applicant ACN: 156 476 827
Summary of Use: For the control of Annual (Wimmera) Ryegrass and certain broadleaved weeds in wheat, barley, oats, cereal rye and triticale
Date of Registration: 16 August 2012
Label Approval No: 67878/57018
Product Name: Crop Care Spark Herbicide
Active Constituent/s: 240g/L imazapic present as the ammonium salt
Applicant Name: Crop Care Australasia Pty Ltd
Applicant ACN: 061 362 347
Summary of Use: For the control of certain annual grass and broadleaf weed in peanuts and sugarcane
Date of Registration: 17 August 2012
Label Approval No: 67753/56795
Product Name: FMC Clopyralid 750 WG Herbicide
Active Constituent/s: 750g/kg clopyralid present as the potassium salt
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures and fallow land
Date of Registration: 17 August 2012
Label Approval No: 67807/56901
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 13
Notice of Registrations – Agricultural Chemical Products
Product Name: Searles Dead Grub Pro For Lawns
Active Constituent/s: 2g/kg bifenthrin
Applicant Name: J C & A T Searle Pty Ltd
Applicant ACN: 002 898 893
Summary of Use: For control of lawn beetles and grubs in home garden
Date of Registration: 17 August 2012
Label Approval No: 67737/56762
Product Name: Spalding Amine 625 Selective Herbicide
Active Constituent/s: 625g/L 2,4-D present as the dimethylamine and diethanolamine salts
Applicant Name: Spalding Holdings Pty. Ltd.
Applicant ACN: 010 155 852
Summary of Use: For the control of broadleaf weeds in fallow before direct drilling or sowing of cereals and pastures; and in cereal crops, pastures, sugarcane, peanuts, and non-agricultural areas
Date of Registration: 17 August 2012
Label Approval No: 67886/57028
Product Name: Sherwood Turf Care Selective Herbicide
Active Constituent/s: 300g/L MCPA present as the potassium salt, 15g/L diflufenican, 20g/L clopyralid present as the potassium salt
Applicant Name: Sherwood Chemicals Public Company Limited
Applicant ACN: N/A
Summary of Use: For the control of certain broadleaf weeds in turf
Date of Registration: 17 August 2012
Label Approval No: 67721/56723
Product Name: Ezycrop Clopyralid 750 SG Herbicide.
Active Constituent/s: 750g/kg clopyralid present as the potassium salt
Applicant Name: Ezycrop Pty Ltd
Applicant ACN: 156 476 827
Summary of Use: For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures and fallow land
Date of Registration: 20 August 2012
Label Approval No: 67879/57019
Product Name: Genfarm Azoxystrobin 500 WG Fungicide
Active Constituent/s: 500g/kg azoxystrobin
Applicant Name: Landmark Operations Limited
Applicant ACN: 008 743 217
Summary of Use: For the control of various diseases of grapes, potatoes, tomatoes, cucurbits, avocados, mangoes, passionfruit and poppies
Date of Registration: 20 August 2012
Label Approval No: 67873/57013
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 14
Notice of Registrations – Agricultural Chemical Products
Product Name: Echem Acetamiprid 225 Insecticide
Active Constituent/s: 225g/L acetamiprid
Applicant Name: Echem (Aust) Pty Limited
Applicant ACN: 089 133 095
Summary of Use: For the control of cotton aphid in cotton
Date of Registration: 20 August 2012
Label Approval No: 67783/56868
Product Name: Spraytech Canola Oil Adjuvant
Active Constituent/s: 832g/L canola oil
Applicant Name: Agrobest IP Pty Ltd
Applicant ACN: 128 029 701
Summary of Use: To increase droplet spread, chemical uptake and rainfastness; improve drift control and reduce foam generation; assist with odour and evaporation reduction
Date of Registration: 20 August 2012
Label Approval No: 67801/56895
Product Name: FMC Wetter 1000
Active Constituent/s: 1000g/L nonyl phenol and alcohol ethoxylates
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For use to increase spray contact, coverage and penetration of herbicides, fungicides and insecticides
Date of Registration: 20 August 2012
Label Approval No: 67816/56912
Product Name: FMC Methomyl 225 Insecticide
Active Constituent/s: 225g/L methomyl (an anti-cholinesterase compound)
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For the control of insect pests in various crops
Date of Registration: 20 August 2012
Label Approval No: 67823/56919
Product Name: Fortune 500 EC (Agriculture) Insecticide
Active Constituent/s: 500g/L chlorpyrifos (an anticholinesterase compound)
Applicant Name: PCT Holdings Pty Ltd
Applicant ACN: 099 023 962
Summary of Use: For post construction management of subterranean termites and other domestic insect pests and certain insect pests in crops and turf
Date of Registration: 20 August 2012
Label Approval No: 67833/56933
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 15
Notice of Registrations – Agricultural Chemical Products
Product Name: FMC Glyphosate 510 Herbicide
Active Constituent/s: 510g/L glyphosate present as the isopropylamine salt.
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For control of a wide range of annual and perennial weeds in a wide variety of situations
Date of Registration: 21 August 2012
Label Approval No: 67829/56929
Product Name: AFA 700 Surfactant
Active Constituent/s: 350g/L soyal phospholipids, 350g/L propionic acid
Applicant Name: Agricultural Formulators Australia Pty Ltd
Applicant ACN: 146 039 661
Summary of Use: For use with herbicides
Date of Registration: 21 August 2012
Label Approval No: 67846/56952
Product Name: Proterra Ethephon 720 Growth Regulator
Active Constituent/s: 720g/L ethephon (an anticholinesterase product)
Applicant Name: Proterra Pty Ltd
Applicant ACN: 120 507 182
Summary of Use: For accelerated boll opening, defoliation and pre-conditioning before defoliation of cotton
Date of Registration: 21 August 2012
Label Approval No: 67864/56999
Product Name: AFA Wetter 1000 Surfactant
Active Constituent/s: 1000g/L nonyl phenol and alcohol ethoxylates
Applicant Name: Agricultural Formulators Australia Pty Ltd
Applicant ACN: 146 039 661
Summary of Use: To increase spray contact, coverage and penetration of herbicides, fungicides and insecticides
Date of Registration: 21 August 2012
Label Approval No: 67845/56951
Product Name: FMC Clopyralid 300 Herbicide
Active Constituent/s: 300g/L clopyralid present as the triisopropanolamine salt
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures, fallow land, forests and industrial situations
Date of Registration: 21 August 2012
Label Approval No: 67808/56902
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 16
Notice of Registrations – Agricultural Chemical Products
Product Name: FMC Triallate 500 Herbicide
Active Constituent/s: 500g/L tri-allate
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For the control of wild oats in wheat, triticale, chick peas, barley, peas, linseed, lupins, canola (rapeseed), faba beans and safflower
Date of Registration: 21 August 2012
Label Approval No: 67818/56914
Product Name: Agro-Essence Diflufenican + MCPA 275 Herbicide
Active Constituent/s: 25g/L diflufenican, 250g/L MCPA present as the ethyl hexyl ester
Applicant Name: Agro-Alliance (Australia) Pty Ltd
Applicant ACN: 130 864 603
Summary of Use: For the control of certain broadleaf weeds in winter cereal and clover
Date of Registration: 21 August 2012
Label Approval No: 67866/57003
Product Name: Barflex 100SC Termiticide & Insecticide
Active Constituent/s: 100g/L bifenthrin
Applicant Name: Barmac Pty Ltd
Applicant ACN: 009 674 953
Summary of Use: For the control of mosquitoes, biting midges, flies and termites
Date of Registration: 22 August 2012
Label Approval No: 67690/56644
3. VARIATIONS
Product Name: Apparent Brush 'N' Wood Herbicide
Applicant Name: Apparent Pty. Ltd.
Applicant ACN: 143 724 136
Summary of Variation: To change the product name from ‘APPARENT TRICLOPYR 300 + PICLORAM 100 HERBICIDE’ to ‘APPARENT BRUSH 'N' WOOD HERBICIDE’
Date of Variation: 8 August 2012
Label Approval No: 66998/57184
Product Name: Terbyne 750WG Herbicide
Applicant Name: Sipcam Pacific Australia Pty Limited
Applicant ACN: 073 176 888
Summary of Variation: To extend the use to include pre-sowing and pre and post-emergence use in sorghum for the control and suppression of various broadleaf and grass weeds
Date of Variation: 13 August 2012
Label Approval No: 56973/52784
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 17
Notice of Registrations – Agricultural Chemical Products
Product Name: Smart Tri-Allate 500 EC Herbicide
Applicant Name: Crop Smart Pty Ltd
Applicant ACN: 093 927 961
Summary of Variation: To approve an update in the withholding periods and safety directions
Date of Variation: 13 August 2012
Label Approval No: 64496/57179
Product Name: Aquafresh By Lo-Chlor Pool Sanitiser
Applicant Name: M I International Pty Ltd T/A Lo-Chlor Chemicals
Applicant ACN: 002 869 089
Summary of Variation: To change the product name from ‘LO-CHLOR AQUACADABRA POOL SANITISER’ to ‘AQUAFRESH BY LO-CHLOR POOL SANITISER’ and update RLP
Date of Variation: 13 August 2012
Label Approval No: 57606/56365
Product Name: Affirm Insecticide
Applicant Name: Syngenta Crop Protection Pty Limited
Applicant ACN: 002 933 717
Summary of Variation: To extend use to control of diamond back moth in canola
Date of Variation: 15 August 2012
Label Approval No: 51321/54036
Product Name: Canopy Insecticide
Applicant Name: Caltex Australia Petroleum Pty Ltd
Applicant ACN: 000 032 128
Summary of Variation: To extend use to suppression of silverleaf whitefly in cotton; green peach aphid and Helicoverpa spp. in pulse and oilseed crops
Date of Variation: 16 August 2012
Label Approval No: 60215/55087
Product Name: Ospray Olympus Fungicide
Applicant Name: Ospray Pty Ltd
Applicant ACN: 110 199 169
Summary of Variation: To add additional uses in wheat and barley
Date of Variation: 16 August 2012
Label Approval No: 62840/57247
Product Name: Imtrade Eradicator 540 Herbicide
Applicant Name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of Variation: To update the restraints and storage and disposal instructions
Date of Variation: 16 August 2012
Label Approval No: 63930/56834
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 18
Notice of Registrations – Agricultural Chemical Products
Product Name: Dupont Coragen Insecticide
Applicant Name: Du Pont (Australia) Ltd
Applicant ACN: 000 716 469
Summary of Variation: To extend use to legume vegetables and sweet corn for control of lepidopteran species of insect pests and to include a surfactant recommendation for use in cucurbits
Date of Variation: 16 August 2012
Label Approval No: 61519/52753
Product Name: Farmoz Colt Herbicide
Applicant Name: Farmoz Pty Limited
Applicant ACN: 050 328 973
Summary of Variation: To approve a new product label
Date of Variation: 17 August 2012
Label Approval No: 63316/54848(A)
Product Name: Rudducks Get Off My Garden Dog And Cat Repellent Gel Contains Natural Aromatic Oils
Applicant Name: Rudducks Pty Ltd
Applicant ACN: 004 666 871
Summary of Variation: To change the product name from ‘GET OFF MY GARDEN DOG & CAT REPELLENT’ to ‘RUDDUCKS GET OFF MY GARDEN DOG AND CAT REPELLENT GEL CONTAINS NATURAL AROMATIC OILS’
Date of Variation: 17 August 2012
Label Approval No: 34023/56020
Product Name: Rudducks Get Off My Garden Dog And Cat Repellent Spray Contains Natural Aromatic Oils
Applicant Name: Rudducks Pty Ltd
Applicant ACN: 004 666 871
Summary of Variation: To change the product name from ‘NEW FORMULA WITH CITRINE FRAGRANCE GET OFF DOG & CAT REPELLENT’ to ‘RUDDUCKS GET OFF MY GARDEN DOG AND CAT REPELLENT SPRAY CONTAINS NATURAL AROMATIC OILS’
Date of Variation: 17 August 2012
Label Approval No: 60368/56019
Product Name: Unitry 480 EC Selective Herbicide
Applicant Name: United Phosphorus Ltd.
Applicant ACN: 066 391 384
Summary of Variation: To include a 5L pack size and extend uses to include additional states for various crops as well as a change the product name from ‘UNI-TRY TRIFLURALIN 480 EC SELECTIVE HERBICIDE’ to ‘UNITRY 480 EC SELECTIVE HERBICIDE ’
Date of Variation: 20 August 2012
Label Approval No: 59227/56845
Product Name: Maxforce Complete Granular Insect Bait
Applicant Name: Bayer Cropscience Pty Ltd
Applicant ACN: 000 226 022
Summary of Variation: To change the product name from 'MAXFORCE GRANULAR INSECT BAIT' to 'MAXFORCE COMPLETE GRANULAR INSECT BAIT'
Date of Variation: 20 August 2012
Label Approval No: 56627/53319
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 19
Notice of Registrations – Agricultural Chemical Products
Product Name: Novaguard Triadimefon 500 WG Fungicide
Applicant Name: Novaguard Pty Ltd
Applicant ACN: 153 121 156
Summary of Variation: To change the product name from ‘NOVA AGRO TRIADIMEFON 500 WG FUNGICIDE’ to ‘NOVAGUARD TRIADIMEFON 500 WG FUNGICIDE’
Date of Variation: 20 August 2012
Label Approval No: 67002/57329
Product Name: DuPont Altriset Termiticide
Applicant Name: Du Pont (Australia) Ltd
Applicant ACN: 000 716 469
Summary of Variation: To add restraint statement relating to use in cavity walls; extend use to include control of Heterotermes ferox and Nasutitermes exitiosus in post construction and above ground areas of termite activity; extend protection period from 3 years to 4 years and revise critical comments associated with above ground use pattern
Date of Variation: 21 August 2012
Label Approval No: 64594/55729
Product Name: Pool Sanitiser Salt Pool Sticks
Applicant Name: Biolab Australia Pty Ltd
Applicant ACN: 005 878 017
Summary of Variation: To change the product name from 'BIOGUARD SALT POOL STICKS POOL SANITISER' to 'POOL SANITISER SALT POOL STICKS'
Date of Variation: 21 August 2012
Label Approval No: 46103/56364
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 20
Notice of Registrations – Veterinary Chemical Products
Veterinary Chemical Products
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 registration in respect of the following
products, with effect from the dates shown.
4. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Profender Allwormer Flavour Tablets For Large Dogs
Active Constituent/s: 30mg emodepside, 150mg praziquantel
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Use: For the treatment and control of roundworms, hookworms, whipworms and tapeworms in dogs
Date of Registration: 10 August 2012
Label Approval No: 63683/46267
Product Name: Profender Allwormer Flavour Tablets For Medium Dogs
Active Constituent/s: 10mg emodepside, 50mg praziquantel
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Use: For the treatment and control of roundworms, hookworms, whipworms and tapeworms in dogs
Date of Registration: 10 August 2012
Label Approval No: 63684/46268
Product Name: Profender Allwormer Flavour Tablets For Small Dogs And Puppies
Active Constituent/s: 3mg emodepside, 15mg praziquantel
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Use: For the treatment and control of roundworms, hookworms, whipworms and tapeworms in dogs
Date of Registration: 10 August 2012
Label Approval No: 63685/46270
Product Name: Maximus Pour-On For Cattle
Active Constituent/s: 5g/L moxidectin
Applicant Name: Ancare Australia Pty Limited
Applicant ACN: 076 252 241
Summary of Use: For the treatment and control of moxidectin sensitive internal and external parasites of cattle
Date of Registration: 13 August 2012
Label Approval No: 67606/56740
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 21
Notice of Registrations – Veterinary Chemical Products
Product Name: Southern Cross Gold OP Spray-On Off-Shears Sheep Lice Treatment
Active Constituent/s: 93.3g/L diazinon (an anticholinesterase compound)
Applicant Name: Agvantage Pty Ltd
Applicant ACN: 097 970 280
Summary of Use: For off-shears control of OP susceptible and SP resistant strains of the sheep body louse (Bovicola ovis)
Date of Registration: 15 August 2012
Label Approval No: 66051/54995
Product Name: Topon DX
Active Constituent/s: 20g/kg gamma oryzanol
Applicant Name: Rapidvite Industries Australasia Pty.Ltd.
Applicant ACN: 006 269 683
Summary of Use: For stimulating the appetite of horses in training
Date of Registration: 16 August 2012
Label Approval No: 61527/41066
Product Name: Neove Monensin 200 - Feed Additive Premix
Active Constituent/s: 200g/kg monensin (as monensin sodium)
Applicant Name: Neove Pharma Australia Pty Limited
Applicant ACN: 140 367 442
Summary of Use: For use as a premix to improve feed efficiency, aid in the control of bloat in cattle and dairy cows; for increased milk production and, as an aid in reducing the severity of non-clinical ketosis in dairy cows; for increased weight gain, feed efficiency, reproductive performance in heifers; as an aid in the prevention of coccidiosis in chickens, cattle and goats
Date of Registration: 17 August 2012
Label Approval No: 64934/49631
Product Name: Caninsulin Vetpen Insulin For Dogs And Cats
Active Constituent/s: 40IU/mL insulin
Applicant Name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of Use: For the treatment of diabetes mellitus in dogs and cats
Date of Registration: 17 August 2012
Label Approval No: 65973/52423
Product Name: Fli-Guard Spray On Sheep Blowfly Treatment
Active Constituent/s: 50g/L dicyclanil
Applicant Name: Pfizer Animal Health A Div Of Pfizer Australia Pty Ltd
Applicant ACN: 008 422 348
Summary of Use: For the protection of sheep, either off-sheers or with any length wool, against flystrike for 18-24 weeks. For the protection of mulesing and marking wounds on sheep against fly strike during the healing process
Date of Registration: 17 August 2012
Label Approval No: 67594/56423
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 22
Notice of Registrations – Veterinary Chemical Products
5. VARIATIONS
Product Name: NV Natrozol Forte Powder - A Source Of Gamma Oryzanol For Horses
Applicant Name: Ceva Animal Health Pty Ltd
Applicant ACN: 002 692 426
Summary of Variation: To change the product name from ‘NATROZOL FORTE POWDER - A SOURCE OF GAMMA ORYZANOL FOR HORSES’ to ‘NV NATROZOL FORTE POWDER - A SOURCE OF GAMMA ORYZANOL FOR HORSES’
Date of Variation: 8 August 2012
Label Approval No: 63525/57155
Product Name: NV Natrozol Powder - A Source Of Gamma Oryzanol For Horses
Applicant Name: Ceva Animal Health Pty Ltd
Applicant ACN: 002 692 426
Summary of Variation: To change the product name from ‘NATROZOL POWDER - A SOURCE OF GAMMA ORYZANOL FOR HORSES’ to ‘NV NATROZOL POWDER - A SOURCE OF GAMMA ORYZANOL FOR HORSES’
Date of Variation: 8 August 2012
Label Approval No: 55619/57156
Product Name: Ensal Enteric Mixture
Applicant Name: Jurox Pty Limited
Applicant ACN: 000 932 230
Summary of Variation: To change the product name from ‘VR ENSAL ENTERIC MIXTURE’ to ‘ENSAL ENTERIC MIXTURE’
Date of Variation: 8 August 2012
Label Approval No: 36286/57182
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 23
Notice – New Agricultural Active Constituent— Penthiopyrad
NOTICE – NEW AGRICULTURAL ACTIVE CONSTITUENT
Penthiopyrad
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a
new active constituent, penthiopyrad.
Penthiopyrad is a fungicide which shows broad antifungal activity on a wide range of crops. It inhibits mitochondrial
function by disrupting complex II (succinate dehydrogenase) in the respiratory electron transport chain. Penthiopyrad is
used to control a range of pathogens including: grey mould, powdery mildew, tomato leaf mould, cucumber corynespora
leaf spot, rust, southern blight, apple and pear scab, apple blossom blight, peach and cherry brown rot. On cereals and
turf, penthiopyrad also has high activity against wheat septoria diseases, rust, brown patch, dollar spot, fairy rings,
anthracnose and snow mould.
Common Name: Penthiopyrad
IUPAC Name: (RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-
carboxamide
CAS Name: N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-
carboxamide
CAS Registry Number: 183675-82-3
Manufacturer’s Code: MTF-753
Minimum Purity: 976 g/kg
Molecular Formula: C16H20F3N3OS
Molecular Weight: 359.4
Structure:
Chemical Family:
Pyrazol Carboxamide
Mode of Action: Fungicide
SUMMARY OF THE APVMA’S EVALUATION OF PENTHIOPYRAD ACTIVE CONSTITUENT
The Pesticides Program of the APVMA has evaluated the chemistry aspects of penthiopyrad active constituent
(manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be
acceptable.
On the basis of the data provided, and the toxicological assessment, it is proposed that the following APVMA Active
Constituent Standard be established for penthiopyrad active constituent:
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 24
Notice – New Agricultural Active Constituent— Penthiopyrad
Constituent Specification Level
Penthiopyrad Penthiopyrad Not less than 976 g/kg
Other compounds of toxicological significance are not expected to occur in penthiopyrad TGAC.
The Office of Chemical Safety (OCS) has completed a toxicological evaluation of penthiopyrad TGAC.
An Acceptable Daily Intake (ADI) of 0.1 mg/kg bw/d has been set, based on a No-Observed Effect Level (NOEL) of
11 mg/kg bw/d in a rat study, after applying a safety factor of 100. An Acute Reference Dose (ARfD) of 0.75 mg/kg bw
has been set based on a rabbit developmental toxicity study, after applying a safety factor of 100.
The National Drugs and Poisons Schedule Committee (NDPSC) has considered penthiopyrad to be appropriate for
inclusion in Schedule 5 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) with a 20% cut-
off exemption from poisons scheduling.
The OCS has indicated that there are no objections on toxicological grounds to the approval of the active constituent
penthiopyrad TGAC.
The APVMA accepts the findings and recommendations of its advisers on these criteria.
The APVMA is satisfied that the proposed importation and use of penthiopyrad 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 penthiopyrad should be granted. Submissions should relate only to matters
that the APVMA is required by legislation to consider in deciding whether to grant the approval. These grounds include
chemistry and manufacture, and toxicity. Submissions should state the grounds on which they are based. Comments
received outside these grounds cannot be considered by the APVMA.
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. A summary of relevant
comments and the APVMA’s response will be published on the APVMA website.
When making a submission please include a:
contact name
company or Group name (if relevant)
postal Address
email 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.
1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 25
Notice – New Agricultural Active Constituent— Penthiopyrad
Written submissions on the APVMA’s proposal to grant approval for penthiopyrad that relate to the grounds for
approval should be addressed in writing to:
Chemistry Manager
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: 02 6210 4936
Fax: 02 6210 4840
Email: [email protected]
Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 26
Notice – New Agricultural Chemical Products—Penthiopyrad in the product DuPont™ Fontelis® Fungicide
NOTICE – NEW AGRICULTURAL CHEMICAL PRODUCTS
Penthiopyrad in the product DuPont™ Fontelis® Fungicide
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from DuPont
(Australia) Limited, for registration of a new product containing the active constituent penthiopyrad. The product
DuPont™ Fontelis® Fungicide The product is for use on a range of fruit and vegetable crops.
PARTICULARS OF THE APPLICATION
Proposed Product Name(s): DUPONT™ FONTELIS® FUNGICIDE
Applicant Company: DuPont (Australia) Limited
Name of Active Constituent: Penthiopyrad
Signal Heading: Schedule 5
Summary of Proposed Use: For the control of fungal diseases in strawberries, pome fruit, stone fruits,
tree nuts, bulb vegetables, brassica vegetables, cucurbit vegetables,
fruiting vegetables, leafy vegetables, and root and tuber vegetables.
Pack Sizes: 50-100mL, 150-250mL, 500mL, 1L, 3L and 5L
Withholding Period: HARVEST:
Strawberries, brassica vegetables, brassica leafy vegetables, fruiting
vegetables (other than cucurbits), stone fruit: Not required when used as
directed.
Cucurbit vegetables: Do not harvest for 1 day after application.
Onions, spring onions, shallots, leafy vegetables: Do not harvest for 3
days after application.
Root and tuber vegetables: Do not harvest for 7 days after application.
Tree nuts: Do not harvest for 14 days after application.
Pome fruit: Do not harvest for 28 days after application.
GRAZING:
Do not graze or cut for stock food.
SUMMARY OF THE APVMA’S EVALUATION OF DUPONT FONTELIS FUNGICDE IN ACCORDANCE WITH
SECTION 14(3)(E) AND (F) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (THE ‘AGVET
CODE’), SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994
The APVMA has evaluated the application and in its assessment in relation to human and environmental
safety under section 14(3)(e) of the Agvet Code, it proposes to determine that:
(i) The APVMA is satisfied that the proposed use of DUPONT™ FONTELIS® FUNGICIDE would not be an undue
hazard to the safety of people exposed to it during its handling and use.
The Office of Chemical Safety and Environmental Health (OCSEH) in the Department of Health and Ageing has
conducted a risk assessment on the product and concluded that it can be used safely.
Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 27
Notice – New Agricultural Chemical Products—Penthiopyrad in the product DuPont™ Fontelis® Fungicide
The main occupational use of the product will be by farmers and their workers. Workers may be exposed to the
product when opening containers, mixing/loading, application, and cleaning up spills and equipment. The main
route of exposure to the product will be dermal with inhalation exposure from the spray also possible.
In the absence of exposure data for the proposed mode of application, the Pesticide Handler Exposure Database
(PHED) Surrogate Exposure Guide was used to estimate exposure. Exposure to the product during mixing and
loading and both ground boom and air-blast application were at an acceptable level when a single layer of clothing
(cotton overalls or equivalent clothing) was worn with or without gloves.
Based on the risk assessment, a First Aid Instruction and Safety Directions have been recommended for the
product label.
(ii) The APVMA is satisfied that the proposed use of DUPONT™ FONTELIS® FUNGICIDE will not be an undue
hazard to the safety of people using anything containing its residues.
The APVMA is satisfied that the proposed use of Dupont™ Fontelis® Fungicide will not be an undue hazard to the
safety of people using anything containing its residues. The product will be used as a foliar spray in a wide range of
fruit and vegetable crops, including strawberries, pome and stone fruit, tree nuts, leafy vegetables, bulb
vegetables, cucurbits, brassicas, root vegetables, and non-cucurbitaceous fruiting vegetables. The APVMA
Residues Section has evaluated the residues aspects of the proposed product and has recommended
amendments to the APVMA MRL Standard for penthiopyrad and for inclusion in the Food Standards Code. Dietary
exposure modelling has shown the expected chronic and acute dietary exposures to penthiopyrad are both below
the relevant health standards. Recommendations regarding withholding periods and protection statements for
livestock have been included on the label.
(iii) The APVMA is satisfied that the proposed use of DUPONT™ FONTELIS® FUNGICIDE containing the active
constituent penthiopyrad is not likely to be harmful to human beings if used according to the product label.
The submitted studies on the active constituent in rats showed that it is extensively and rapidly absorbed by the
oral route (>83%) and excreted rapidly. The total absorbable dose in vitro for rat and human skin was 53% and
19% respectively. Penthiopyrad is of low acute oral, dermal and inhalational toxicity in rats. It was not a skin irritant
in rabbits but was considered a slight eye irritant in the same species. It was not a skin sensitiser in guinea pigs.
In repeat dose studies, liver toxicity was common in mice, rats and dogs, with thyroid toxicity also observed in mice
and rats. There were findings of an increased incidence of thyroid follicular epithelial adenomas in male rats, and
hepatocellular carcinomas in male mice. Overall, OCS considers that the weak induction of thyroid follicular
epithelial adenomas in male rats occurred via thyroid hormone perturbations and that the observed tumours are of
limited relevance to humans. Consequently, penthiopyrad is not considered to be a carcinogenic hazard to
humans.
Penthiopyrad was not a reproductive or developmental toxicant, and tested negative in vitro and in vivo in a battery
of mutagenicity and/or genotoxicity studies. Additionally, the available data was not considered to demonstrate a
neurotoxic or immunotoxic potential.
The product DuPont™ Fontelis® Fungicide is of low acute oral, dermal and inhalational toxicity in rats. It is not a
skin or eye irritant in rabbits nor a skin sensitiser in guinea pigs and mice.
Based on an assessment of the toxicology, it was considered that there should be no adverse effects on human
health from the use of DuPont™ Fontelis® Fungicide when used in accordance with the label directions.
Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 28
Notice – New Agricultural Chemical Products—Penthiopyrad in the product DuPont™ Fontelis® Fungicide
(iv) The APVMA is satisfied that the proposed use of DUPONT™ FONTELIS® FUNGICIDE containing the new active
constituent, penthiopyrad is not likely to have an unintended effect that is harmful to animals, plants or the
environment if used according to the product label directions.
The Department of Sustainability, Environment, Water, Population and Communities has assessed data in support
of the proposed use and has concluded that the risks to the environment from uses are acceptable provided that
the draft label is updated to meet current requirements.
Penthiopyrad is stable with minimal or no detectable degradation by abiotic processes (photolysis and hydrolysis).
It undergoes slow degradation by biotic processes in both soil and water under laboratory conditions. However,
under field conditions it dissipates more rapidly. Finally, penthiopyrad does not bio-accumulate in fish.
Penthiopyrad and the SC formulation are not toxic to birds, bees, earthworms, non-target arthropods or, plants and
did not affect the short-term respiration and nitrogen turnover in a soil. They are considered toxic to very toxic to
fish and aquatic invertebrates, and at worst toxic algae.
At the proposed rates, the major potential risk to the environment was penthiopyrad’s potential to accumulate in the
soil and the water compartment from multiple applications. With conservative modelling, acceptable risk to aquatic
organisms was found from run-off water entering environmental waters. Similarly the risk to water and sediment
dwelling organisms from spray drift was found to be acceptable if downwind no-spray zones are implemented.
The risk assessment determined that the chemical is unlikely to pose an environmental risk under the proposed
use patterns, provided the draft label is updated to meet current requirements.
The APVMA has considered the findings of the Department of Sustainability, Environment, Water, Population and
Communities and accepts these conclusions.
(v) The APVMA is considering whether the proposed use of DUPONT™ FONTELIS® FUNGICIDE would not
adversely affect trade between Australia and places outside Australia.
Export of treated produce containing finite (measurable) residues of penthiopyrad may pose a risk to Australian
trade in situations where (i) no residues tolerance (import tolerance) is established in the importing country or (ii)
where residues in Australian product are likely to exceed a residue tolerance (import tolerance) established in the
importing country.
The overall risk to export trade in animal commodities is considered to be low, as detectable residues of
penthiopyrad are not expected in meat, milk, eggs or offal, and MRLs have been recommended at the limit of
quantitation.
Detectable residues are expected in a number of commodities including tree nuts, strawberries, brassica
vegetables, leafy vegetables, bulb vegetables, fruiting vegetables and root vegetables. However, none of these are
significant export commodities, and the corresponding risk to trade is expected to be low.
Detectable residues are also expected in pome fruit and stone fruit, which are significant export commodities.
Of the export markets for pome and stone fruit, Australian fruit are expected to meet the current or forthcoming
standards of Canada, France and the UK, while New Zealand accepts Australian MRLs under the Trans-Tasman
mutual recognition agreement. Other export markets such as Hong Kong, Thailand, Singapore, Indonesia and
Papua New Guinea do not currently have either their own or Codex MRLs. There may therefore be some risk to
exports to these destinations.
Comment is sought from the relevant industry groups on the perceived level of risk and whether any industry-
initiated strategies are required to manage that risk.
Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 29
Notice – New Agricultural Chemical Products—Penthiopyrad in the product DuPont™ Fontelis® Fungicide
(vi) 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.
FURTHER INFORMATION
A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Public
Consultation’ page, www.apvma.gov.au/consultation/public or by contacting the APVMA as indicated below.
MAKING A SUBMISSION
In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written
submission as to whether the application for registration of DUPONT™ FONTELIS® FUNGICIDE should be granted.
Submissions should relate only to matters that the APVMA is required by legislation to take into account in deciding
whether to grant the application. These grounds include occupational health and safety, chemistry and manufacture,
residues, safety and first aid, environmental fate and toxicity, trade and efficacy. Submissions should state the
grounds on which they are based. Comments received outside these grounds cannot be considered by the APVMA.
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact
listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.
Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and
in determining appropriate conditions of registration and product labelling.
When making a submission please include:
contact name
company or Group name (if relevant)
email or postal address
the date you made the submission.
All personal and confidential commercial information (CCI)2 material contained in submissions will be treated
confidentially.
Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for
registration should be addressed in writing to:
Contact Officer
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: 02 6210 4700
Fax: 02 6210 4776
Email: [email protected]
2 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 30
Notice – New Veterinary Chemical Products—Dexmedetomidine hydrochloride in the product Dexdomitor Injectable Sedative and Analgesic for Dogs and Cats
NOTICE – NEW VETERINARY CHEMICAL PRODUCTS
Dexmedetomidine hydrochloride in the product Dexdomitor Injectable Sedative and Analgesic for Dogs and Cats
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Pfizer Animal
Health, A division of Pfizer Australia Pty Ltd, for registration of a new product containing dexmedetomidine. The product
is DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC FOR DOGS AND CATS. The product is to be used as a
sedative and analgesic in dogs and cats.
PARTICULARS OF THE ACTIVE CONSTITUENT
Common Name: Dexmedetomidine hydrochloride
CAS Name: 5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
Chemical Name: (S)-4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
CAS Registry Number: 145108-58-3
Minimum Purity: 980 g/kg (dry basis)
Molecular Formula: C13H16N2.HCl
Molecular Weight: 236.7
Structure:
Chemical Family: imidazole
Mode of Action: alpha2 adrenoceptor agonist
SUMMARY OF THE APVMA’S EVALUATION OF DEXMEDETOMIDINE HYDROCHLORIDE ACTIVE CONSTITUENT
The Pharmaceutical Chemistry Section of the APVMA has evaluated the chemistry and manufacture aspects of
dexmedetomidine hydrochloride and is satisfied that all the data requirements (including physico-chemical properties,
spectral identification, manufacturing and quality control aspects, active constituent specification, stability data, batch
analysis data, analytical methods and packaging) necessary for the approval of this new active constituent have been
met.
PARTICULARS OF THE APPLICATION
Proposed Product Name(s): DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC FOR
DOGS AND CATS
Applicant Company: Pfizer Animal Health, A division of Pfizer Australia Pty Ltd
Name of Active Constituent: Dexmedetomidine hydrochloride
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 31
Notice – New Veterinary Chemical Products—Dexmedetomidine hydrochloride in the product Dexdomitor Injectable Sedative and Analgesic for Dogs and Cats
Signal Heading: Prescription Animal Remedy - Schedule 4
Summary of Proposed Use: Sedative and analgesic for dogs and cats
Pack Sizes: 10mL
Withholding Period: N/A
SUMMARY OF THE APVMA’S EVALUATION OF DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC FOR
DOGS AND CATS IN ACCORDANCE WITH SECTION 14(3)(E) AND (F) OF THE AGRICULTURAL AND
VETERINARY CHEMICALS CODE (THE ‘AGVET CODE’), SCHEDULED TO THE AGRICULTURAL AND
VETERINARY CHEMICALS CODE ACT 1994
The APVMA has evaluated the application and in its assessment in relation to human and environmental safety under
section 14(3)(e) of the Agvet Code, it proposes to determine that:
(vii) The APVMA is satisfied that the proposed use of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC
FOR DOGS AND CATS would not be an undue hazard to the safety of people exposed to it during its handling and
use.
The Office of Chemical Safety (OCS) in the Department of Health and Ageing has conducted a risk assessment on
the product and concluded that it can be used safely.
Based on the findings of the toxicological studies evaluated, dexmedetomidine hydrochloride has high intravenous
and subacute toxicity in mice, rats and dogs. It is unlikely to be a skin sensitiser. No studies on the skin and eye
irritation potential of dexmedetomidine were submitted with this application, however, medetomidine, the racemic
mixture of dexmedetomidine and levomedetomidine, was not a skin irritant or an eye irritant in guinea pigs or
rabbits, respectively. There was no data available on acute oral or inhalational toxicity; however, based on the use
pattern of the product, exposure via these routes is unlikely. The APVMA has considered and accepts the findings
and recommendations of the OCS evaluation.
(viii) The APVMA is satisfied that the proposed use of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC
FOR DOGS AND CATS will not be an undue hazard to the safety of people using anything containing its residues.
The product is for use in companion animals (dogs and cats) only. Dexmedetomidine hydrochloride is unlikely to
enter the food chain and therefore the determinations of an Acceptable Daily Intake (ADI) and Acute Reference
Dose (ARfD) are not considered necessary.
(ix) The APVMA is satisfied that the proposed use of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC
FOR DOGS AND CATS containing the active constituent dexmedetomidine is not likely to be harmful to human
beings if used according to the product label directions.
Dexmedetomidine is in schedule 4 of the SUSMP. Based on the toxicity profile of dexmedetomidine hydrochloride
and the use pattern of the product; it is proposed that a schedule for classification for this product remains
appropriate. The signal heading that corresponds to Schedule 4 and the First Aid instructions recommended by the
OCS will appear on the product label.
(x) The APVMA is satisfied that the proposed use of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC
FOR DOGS AND CATS is not likely to have an unintended effect that is harmful to animals, plants or the
environment if used according to the product label directions.
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 32
Notice – New Veterinary Chemical Products—Dexmedetomidine hydrochloride in the product Dexdomitor Injectable Sedative and Analgesic for Dogs and Cats
The Department of Sustainability, Environment, Water, Population and Communities (DSEWPAC), have
recommended to the APVMA that the use of the product in the proposed manner is not expected to have an
unintended effect that is harmful to the environment. The APVMA has considered these findings and accepts the
recommendations of DSEWPAC on this criterion.
(xi) The APVMA is satisfied that the proposed use of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC
FOR DOGS AND CATS would not adversely affect trade between Australia and places outside Australia as the
product is for use in dogs and cats, which are not food-producing animals and do not produce any major Australian
export commodities.
(xii) 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.
FURTHER INFORMATION
MAKING A SUBMISSION
In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written
submission as to whether the application for registration of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC
FOR DOGS AND CATS should be granted. Submissions should relate only to matters that the APVMA is required by
legislation to take into account in deciding whether to grant the application. These grounds include occupational health
and safety, chemistry and manufacture, residues, safety and first aid, environmental fate and toxicity, trade and
efficacy. Submissions should state the grounds on which they are based. Comments received outside these grounds
cannot be considered by the APVMA.
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact
listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.
Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and
in determining appropriate conditions of registration and product labelling.
When making a submission please include:
contact name
company or Group name (if relevant)
email or postal address
the date you made the submission.
All personal and confidential commercial information (CCI)3 material contained in submissions will be treated
confidentially.
Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for
registration should be addressed in writing to:
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: 02 6210 4700
Fax: 02 6210 4741
Email: [email protected]
3 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 33
Other Notices – Cancellation of Active Constituent Approvals at the Request of the Approval Holder
OTHER NOTICES
Cancellation of Active Constituent Approvals at the Request of the Approval Holder
In accordance with Section 42 of the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code), if an
interested or approved person in relation to an approval or registration gives to the APVMA a written notice requesting
the APVMA to cancel the approval or registration, the APVMA must give written notice of its decision on the request to
the person(s) who made the request.
At the request of the approval holder, the APVMA has cancelled the approvals of the following active constituents:
Active No. Active Name Approval Holder Date of Effect
44450 ALDICARB MANUFACTURING
CONCENTRATE
BAYER CROPSCIENCE PTY LTD 14 August 2012
44025 ALDICARB MANUFACTURING
CONCENTRATE
BAYER CROPSCIENCE PTY LTD 14 August 2012
59053 IODOMETHANE ARYSTA LIFESCIENCE NORTH
AMERICA CORPORATION
14 August 2012
The following instructions set out how a person can deal with the cancelled actives.
SUPPLY
A person may supply or cause to be supplied active constituents manufactured prior to 14 August 2012 until
14 August 2014.
After 14 August 2014 it will be an offence against the Agvet Codes to have possession or custody of the active
constituents with the intention to supply the active constituents.
USE
Any person who possesses, has custody of, uses, or otherwise deals with the listed active constituents in accordance
with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have
custody of, use or otherwise deal with the active constituents after the approvals have been cancelled until
14 August 2014.
The supply and use of the active constituents must be in accordance with the conditions of approval, including any
conditions relating to the shelf life or expiry date.
It is an offence to possess, have custody of, use, or deal with the active constituents listed in the table in a manner that
contravenes the above instructions.
APVMA CONTACT
For any enquiries or further information about this matter, please contact:
Chemical Review/AERP Contact Officer
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: 02 6210 4749
Fax: 02 6210 4776
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 34
Other Notices – Variations to Standard 1.4.2 of the Australia New Zealand Foods Standards Code
Variations to Standard 1.4.2 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 Standard 1.4.2 – Maximum Residue Limits of the Australia New Zealand
Food Standards Code. This notice pertains to proposal numbered 12O gazetted on 5 June 2012 (No. APVMA 11).
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 Standard 1.4.2. A copy of the Amendment Instrument
(No. APVMA 8, 2012) accompanies this notice. For a complete and up-to-date version of Standard 1.4.2, including these
amendments together with their Explanatory Statement, please refer to the Federal Register of Legislative Instrument
available on the Comlaw website at http://www.comlaw.gov.au.
Based on dietary exposure assessments and current health standards, the APVMA and FSANZ are satisfied that these
MRLs are not harmful to public health. MRLs contained in Standard 1.4.2 provide the limits for residues of agricultural
and veterinary chemicals that may legitimately occur in foods. By this means, Standard 1.4.2 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 Government of Australia and the Government of New Zealand 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:
Residues Contact Officer
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: 02 6210 4837
Fax: 02 6210 4840
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 35
Other Notices – Variations to Standard 1.4.2 of the Australia New Zealand Foods Standards Code
Australia New Zealand Food Standards Code —
Standard 1.4.2 — Maximum Residue Limits Amendment Instrument No. APVMA 8, 2012
I, Rajumati Bhula, Program Manager, Pesticides Program and 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.
Rajumati Bhula
Program Manager
Pesticides Program
Dated this twenty-first day of August 2012
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 36
Other Notices – Variations to Standard 1.4.2 of the Australia New Zealand Foods Standards Code
Part 1 Preliminary
1 Name of Instrument
This Instrument is the Australia New Zealand Food Standards Code — Standard 1.4.2—Maximum Residue Limits Amendment Instrument No. APVMA 8, 2012.
2 Commencement
Pursuant to subsection 82(8) of the Food Standards Australia New Zealand Act 1991, this Amendment Instrument commences on the day a copy of 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 No. APVMA
17 of
28 August 2012.
3 Object
The object of this Instrument is for the APVMA to make variations to Standard 1.4.2 — Maximum Residue Limits of 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 Standard 1.4.2 — Maximum Residue Limits of 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. The whole of the Australia New Zealand Food Standard Code (including Standard 1.4.2) was further published in Gazette P 30 of 20 December 20004.
Part 2 Variations to Standard 1.4.2 — Maximum Residue Limits
5 Variations to Standard 1.4.2
The Schedule to this Instrument sets out the variations made to the Principal Instrument by this Amendment Instrument.
4 Note An amendment history from 20 December 2000 appears at the beginning of the Australia New
Zealand Food Standard Code.
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 37
Other Notices – Variations to Standard 1.4.2 of the Australia New Zealand Foods Standards Code
Schedule
Variations to Standard 1.4.2 — Maximum Residue Limits
1 Variations
(1) The Principal Instrument is varied by:
(a) omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –
Linuron
Sum of linuron plus 3,4-dichloroaniline, expressed as linuron
Vegetables [except celeriac; celery; leek]
*0.05
Pirimicarb
Sum of pirimicarb, demethyl-pirimicarb and the N-formyl-(methylamino) analogue
(demethylformamido-pirimicarb), expressed as pirimicarb
Vegetables [except adzuki bean (dry); leafy vegetables; lupin (dry); mung bean (dry); onion, Welsh; shallot; soya bean (dry); spring onion; sweet corn (corn-on-the-cob)]
1
(b) inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals –
Chlorantraniliprole
Plant commodities and animal commodities other than milk: Chlorantraniliprole
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
Radish T0.05 Swede T0.05 Turnip, Garden T0.05
Chlorfenapyr
Chlorfenapyr
Onion, Welsh T1
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 38
Other Notices – Variations to Standard 1.4.2 of the Australia New Zealand Foods Standards Code
Clofentezine
Clofentezine
Tomato T1
Cyprodinil
Cyprodinil
Lettuce, leaf T10
Difenoconazole
Difenoconazole
Celeriac T0.5
Fenbutatin oxide
Bis[tris(2-methyl-2-phenylpropyl)tin]-oxide
Nectarine 3 Tomato T2
Fludioxonil Commodities of animal origin: Sum of fludioxonil
and oxidisable metabolites, expressed as fludioxonil Commodities of plant origin: Fludioxonil
Lettuce, leaf T10
Haloxyfop
Sum of haloxyfop, its esters and conjugates, expressed as haloxyfop
Guar bean (dry) T2
Linuron
Sum of linuron plus 3,4-dichloroaniline, expressed as linuron
Parsnip T0.05 Vegetables [except celeriac; celery;
leek; parsnip] *0.05
Pirimicarb
Sum of pirimicarb, demethyl-pirimicarb and the N-formyl-(methylamino) analogue
(demethylformamido-pirimicarb), expressed as pirimicarb
Celeriac 0.1 Vegetables [except adzuki bean
(dry); celeriac; leafy vegetables; lupin (dry); mung bean (dry); onion, Welsh; shallot; soya bean (dry); spring onion; sweet corn (corn-on-the-cob)]
1
Prochloraz
Sum of prochloraz and its metabolites containing the 2,4,6-trichlorophenol moiety, expressed as
prochloraz
Litchi T2
Pyraclostrobin Commodities of plant origin: Pyraclostrobin
Commodities of animal origin: Sum of pyraclostrobin and metabolites hydrolysed to 1-(4-chloro-phenyl)-
1H-pyrazol-3-ol, expressed as pyraclostrobin
Litchi T2
Pyriproxyfen
Pyriproxyfen
Strawberry T0.5
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 39
Other Notices – Variations to Standard 1.4.2 of the Australia New Zealand Foods Standards Code
(c) omitting from Schedule 1, under the entries for the following chemicals, the maximum residue limit for the food, substituting –
Ioxynil
Ioxynil
Leek T2
Iprodione
Iprodione
Garlic T10
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 40
Other Notices – Addendum to the Record of Approved Active Constituents
Addendum to the Record of Approved Active Constituents
The current Record of Approved Active Constituents for Registered Chemical Products is also accessible from the APVMA
website, www.apvma.gov.au.
APPROVED SINCE GAZETTE NO. 16, 14 AUGUST 2012
For use in agricultural and/or veterinary chemical products:
Common Name Approval Holder Manufacturer and Site of Manufacture Approval No.
S-METOLACHLOR AGROGILL CHEMICALS PTY LTD
SHANDONG ZHONGNONG MINCHANG
CHEMICAL INDUSTRY CO., LTD
NO. 516 YONGXIN ROAD BINBEI TOWN BINZHOU SHANDONG CHINA CHINA
67054
BOSCALID AGROGILL CHEMICALS PTY LTD
NANTONG JIAHE CHEMICALS CO LTD QINGLONG PORT CHEMICAL PORT DISTRICT HAIMEN 226121 JIANGSU PROVINCE CHINA
67486
SULFOSULFURON AGROSHINE AUSTRALIA PTY LTD
ZHEJIANG BOSST CROPSCIENCE CO., LTD. NO. 1 FANGJIADAI RD HAIYAN ECONOMIC DEVELOPMENT ZONE HAIYAN, ZHEJIANG P.R CHINA
67328
TRICLOPYR BUTOXYETHYL ESTER
MAX(RUDONG) CHEMICALS CO., LTD
MAX(RUDONG) CHEMICALS CO., LTD YANGKOU CHEMICALS INDUSTRY PARK RUDONG COUNTY 226407 JIANGSU PROVINCE CHINA
67316
APVMA CONTACT
For further information please contact:
Application Management & Enquiries
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: 02 6210 4701
Fax: 02 6210 4721
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 41
Other Notices – Application Summaries
Application Summaries
The APVMA publishes complete application summaries on the APVMA website, www.apvma.gov.au. They are published in
weekly instalments using the date the application was accepted for assessment. If an application summary has been
amended, the APVMA will publish the amended version on the website and list it separately in the APVMA Gazette Notice for
Application Summaries.
As a requirement of Regulations 8C and E of the Agvet Code, some product names will appear as 'NOT AVAILABLE'.
A summary will be removed from the website 28 days after the application has been finalised. Therefore, some summaries
published in this notice may have already been removed prior to the Gazette being published.
APPLICATION SUMMARIES PUBLISHED SINCE THOSE PUBLISHED IN APVMA GAZETTE NO.16, 14 AUGUST 2012
Application No. Name
50445 KENSO AGCARE CLETHO 240 EC SELECTIVE HERBICIDE
52867 GLYPHOSATE
53041 MELPAT MILDEX WG FUNGICIDE
54146 UNITED FARMERS DIURON 900 WG HERBICIDE
54527 FENOXAPROP-P-ETHYL
54556 CTC PREMIX 200
55378 LUNA PRIVILEGE FUNGICIDE
56734 SELOVIN LA LONG ACTING SELENIUM INJECTION FOR CATTLE
56910 NEOVAC VACCINE
56944 ROACH WIZZ
56976 SAFLUFENACIL
57049 GENFARM METOLACHLOR 960 HERBICIDE
57117 AGRITRADING GLYPHOSATE 700 SG HERBICIDE
57147 EQUIVAC EST EQUINE SALMONELLA TYPHIMURIUM VACCINE
57149 AUSAGRI GLYPHOSATE 450 HERBICIDE
57150 COUNTRY 2,4-D / PICLORAM HERBICIDE
57178 NOVAGUARD DIFLUFENICAN + MCPA SELECTIVE HERBICIDE
57179 SMART TRI-ALLATE 500 EC HERBICIDE
57219 EZYCROP TRIASULFURON 750 WG HERBICIDE
57224 EZYCROP CHLORPYRIFOS 500 INSECICIDE
57242 CROP CARE VIVANDO FUNGICIDE
57248 NOT AVAILABLE
57249 NOT AVAILABLE
57250 NOT AVAILABLE
Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 42
Other Notices – Application Summaries
Application No. Name
57277 NOT AVAILABLE
55918 TORDON REGROWTHMASTER HERBICIDE
56141 ILIUM METHADONE INJECTION
56577 REVUS FUNGICIDE
56842 TERMATRIX TERMITE FOAM INSECTICIDE
56899 FMC BROMOXYNIL & MCPA HERBICIDE
56915 FMC TERBUTRYN MCPA HERBICIDE
56954 ERYVAC VACCINE
57104 LUCILURE SHEEP BLOWFLY ATTRACTANT
57106 FMC HALOXYFOP 520 HERBICIDE
57119 APPARENT DIFLUFENICAN 500 SC HERBICIDE
57123 TALON ANT KILLER GEL
57124 OPTIGARD ANT BAIT GEL
57151 EARTHCORE GLYPHOSATE 360 WEED KILLER
57167 CROP CARE SENTRY HERBICIDE
57172 WIPE-OUT DRY 700 SG HERBICIDE
57173 WONSTAR 250SC FUNGICIDE
57292 NOT AVAILABLE
57323 EZYCROP DICLOFOP-METHYL 375 EC HERBICIDE
57324 EZYCROP HALOXYFOP 520 HERBICIDE
57393 NUFARM ARCHER HERBICIDE
APVMA CONTACT
For further information please contact:
Application Management and Enquiries Team (AME)
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: 02 6210 4701
Fax: 02 6210 4721
Email: [email protected]