No. APVMA 23, Tuesday, 20 November 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 23, Tuesday, 20 November 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.
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APVMA CONTACTS
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For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Notice of Registrations 4 Agricultural Chemical Products .............................................................................................................................................. 4 Veterinary Chemical Products .............................................................................................................................................. 14
Other Notices 16 Licensing of Veterinary Chemical Manufacturers ................................................................................................................. 16 Cancellation of Product Registrations at the Request of the Registrant ............................................................................... 22 Amendments to the APVMA MRL Standard—Outcomes of Review Decisions .................................................................... 23 Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade ............................................................................................................................................................... 26 Interim Pesticide and Veterinary Medicines Product Sales 2011-12 Financial Year ............................................................ 28 Addendum to the Record of Approved Active Constituents .................................................................................................. 32 Application Summaries ......................................................................................................................................................... 33
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 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. AGRICULTURAL PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS
Product Name: A32 Dispersant
Active Constituent/s: 17g/L n-coco-alkyltrimethylenediamines, 115g/L n-oleyl-1,3-diaminopropane
Applicant Name: Veolia Water Systems (Australia) Pty Ltd
Applicant ACN: 055 254 003
Summary of Use: For treatment of seawater cooling systems to prevent corrosion, biofilm formation and attachment of seawater organisms
Date of Registration: 31 October 2012
Label Approval No: 55270/25902
Product Name: Beetlejuice Carpophilus Trapping System
Active Constituent/s: Part A: 352g/L ethanol, ethyl acetate, 2-methyl-1-propanol, 2-methyl-1-butanol, 3-methyl-1-butanol. Part B: 970g/L ethanol, acetaldehyde. Pheromone Lure: 15mg per lure Carpophilus Aggregation Pheromones
Applicant Name: AT No.2 Pty Ltd
Applicant ACN: 155 660 021
Summary of Use: For monitoring and management of Carpophilus beetles in orchards
Date of Registration: 14 November 2012
Label Approval No: 65966/52407
2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Novaguard Triclopyr 600 Herbicide
Active Constituent/s: 600g/L triclopyr present as the butoxyethyl ester
Applicant Name: Novaguard Pty Ltd
Applicant ACN: 153 121 156
Summary of Use: For control of various woody and broadleaf weeds in agricultural non-crop areas, commercial and industrial areas, forests, pastures, rights of way, fencelines, fire trails, fallow, stubble, firebreaks and sorghum
Date of Registration: 31 October 2012
Label Approval No: 68041/57343
Product Name: Ezycrop 2,4-D IPA 300 Herbicide
Active Constituent/s: 300g/L 2,4-D present as the isopropylamine salt
Applicant Name: Ezycrop Pty Ltd
Applicant ACN: 156 476 827
Summary of Use: For the control of emerged broadleaf weeds prior to sowing crops, pastures in conservation tillage situations and for selective weed control in crops and various situations
Date of Registration: 31 October 2012
Label Approval No: 68049/57357
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 5
Notice of Registrations - Agricultural Chemical Products
Product Name: Mexel 432
Active Constituent/s: 17g/L n-coco-alkyltrimethylenediamines, 115g/L n-oleyl-1,3-diaminopropane
Applicant Name: Mistring Pty Limited & Nabone Pty Limited T/A Integra Water Treatment Solutions
Applicant ACN: 050 046 350, 065 429 370
Summary of Use: For treatment of seawater cooling systems to prevent corrosion and biofilm formation
Date of Registration: 31 October 2012
Label Approval No: 59326/35556
Product Name: Rodenthor Soft Bait Rodenticide
Active Constituent/s: 0.05g/kg brodifacoum
Applicant Name: ZAPI S.P.A
Applicant ACN: N/A
Summary of Use: For the control of rodents around industrial, commercial, agricultural and residential buildings
Date of Registration: 1 November 2012
Label Approval No: 66331/55716
Product Name: Binkill Protector
Active Constituent/s: 186g/kg dichlorvos (an anticholinesterase compound)
Applicant Name: Lazco Investments Pty Ltd
Applicant ACN: 069 972 354
Summary of Use: For killing flies and maggots for up to 3 months in wheelie bins
Date of Registration: 2 November 2012
Label Approval No: 67600/56432
Product Name: EzyCrop Clodinafop 240 EC Herbicide
Active Constituent/s: 60g/L cloquintocet-mexyl, 240g/L clodinafop
Applicant Name: Ezycrop Pty Ltd
Applicant ACN: 156 476 827
Summary of Use: For the control of wild oats, Paradoxa grass (annual phalaris), canary grass and annual ryegrass in wheat
Date of Registration: 5 November 2012
Label Approval No: 68067/57422
Product Name: I Love My Pet Multi Use Disinfectant Concentrate For Cages, Kennels, Hydrobath And Dogwash Units
Active Constituent/s: 7.7g/L benzalkonium chloride
Applicant Name: My Pet Products Australia Pty Ltd
Applicant ACN: 068 507 148
Summary of Use: For the disinfection of hydrobaths, kennels, catteries, aviaries, stables, poultry cages, feeding utensils, toilets (not septic systems), walls, floors in household situations and other habitats.
Date of Registration: 5 November 2012
Label Approval No: 68018/57279
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 6
Notice of Registrations - Agricultural Chemical Products
Product Name: Farmalinx Tripyr 600 EC Herbicide
Active Constituent/s: 600g/L triclopyr present as the butoxyethyl ester
Applicant Name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of Use: For the control of woody weeds and melons
Date of Registration: 5 November 2012
Label Approval No: 68143/57609
Product Name: Agro-Essence Diflufenican 500 Herbicide
Active Constituent/s: 500g/L diflufenican
Applicant Name: Agro-Alliance (Australia) Pty Ltd
Applicant ACN: 130 864 603
Summary of Use: For control of certain weeds in clover-based pasture, field peas, lentils, lupins and oilseed poppy crops
Date of Registration: 5 November 2012
Label Approval No: 67867/57004
Product Name: Farmalinx Epoxicon 125 SC Fungicide
Active Constituent/s: 125g/L epoxiconazole
Applicant Name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of Use: For the control of certain fungal diseases including stripe rust of wheat and specified fungal diseases of barley
Date of Registration: 5 November 2012
Label Approval No: 68071/57428
Product Name: Pro Stomper Glyphosate 510
Active Constituent/s: 510g/L glyphosate present as the isopropylamine salt
Applicant Name: Australian Progressive Supplies Pty Ltd
Applicant ACN: 149 848 591
Summary of Use: For control of a wide range of annual and perennial weeds in a wide variety of situations.
Date of Registration: 5 November 2012
Label Approval No: 68149/57633
Product Name: Protect-Us Professional Granular Ant Bait
Active Constituent/s: 7.3g/kg hydramethylnon
Applicant Name: Ensystex Australasia Pty Ltd
Applicant ACN: 102 221 965
Summary of Use: For use in household, industrial and institutional situations for the control of common household ants
Date of Registration: 5 November 2012
Label Approval No: 68012/57272
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 7
Notice of Registrations - Agricultural Chemical Products
Product Name: Opal Trifluralin 480 Selective Herbicide
Active Constituent/s: 480g/L trifluralin
Applicant Name: Opal Australasia Pty Ltd
Applicant ACN: 103 454 879
Summary of Use: For pre-emergence control of annual grasses and certain broadleaf weeds in certain horticultural and agricultural crops
Date of Registration: 5 November 2012
Label Approval No: 68107/57514
Product Name: Ezycrop Methomyl 225 Insecticide
Active Constituent/s: 225g/L methomyl (an anti-cholinesterase compound).
Applicant Name: Ezycrop Pty Ltd
Applicant ACN: 156 476 827
Summary of Use: For the control of insect pests in various crops
Date of Registration: 6 November 2012
Label Approval No: 68157/57647
Product Name: Freezone Glyphosate 680 Granules Tuffweed Weed Killer
Active Constituent/s: 680g/kg glyphosate present as the monoammonium salt
Applicant Name: Freezone Public Health Pty Ltd
Applicant ACN: 132 080 098
Summary of Use: For the control of woody weeds and grasses in home garden situation
Date of Registration: 6 November 2012
Label Approval No: 66105/52741
Product Name: FMC Glyder Dry 700 Herbicide
Active Constituent/s: 700g/kg glyphosate present as the mono-ammonium salt
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For the control of many annual and perennial weeds in certain situations
Date of Registration: 6 November 2012
Label Approval No: 68162/57671
Product Name: Hortico Weed & Green Easy To Use Hose On
Active Constituent/s: 2.3g/L dicamba present as the dimethylamine salt, 15g/L MCPA present as the dimethylamine salt
Applicant Name: Duluxgroup (Australia) Pty Ltd
Applicant ACN: 000 049 427
Summary of Use: For selective control of common broadleaf weeds in home garden lawns
Date of Registration: 7 November 2012
Label Approval No: 67251/55596
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 8
Notice of Registrations - Agricultural Chemical Products
Product Name: Ezycrop Tebuconazole 430 SC Fungicide
Active Constituent/s: 430g/L tebuconazole.
Applicant Name: Ezycrop Pty Ltd
Applicant ACN: 156 476 827
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: 7 November 2012
Label Approval No: 68072/57429
Product Name: Kenso Agcare Ken-Up 500 CT Herbicide
Active Constituent/s: 500g/L glyphosate present as the isopropylamine salt
Applicant Name: Kenso Corporation (M) Sdn. Bhd.
Applicant ACN: N/A
Summary of Use: For non-selective control of many annual, perennial and aquatic weeds
Date of Registration: 7 November 2012
Label Approval No: 68140/57603
Product Name: Turf Culture Monarch Insecticide
Active Constituent/s: 125g/L fipronil
Applicant Name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of Use: For the control of Argentine Stem Weevil (Listronotus bonariensis), Funnel Ant (Aphaenogaster pythia ) and Mole Cricket (Sapteriscus didactylus and Gryllotalpa spp.) in recreational, domestic and commercial turf
Date of Registration: 7 November 2012
Label Approval No: 66187/52947
Product Name: Genfarm Soy Prop 700 Surfactant
Active Constituent/s: 350g/L soyal phospholipids, 350g/L propionic acid
Applicant Name: Landmark Operations Limited
Applicant ACN: 008 743 217
Summary of Use: For use as a surfactant
Date of Registration: 8 November 2012
Label Approval No: 68105/57496
Product Name: Belt 480 SC Insecticide
Applicant Name: Bayer Cropscience Pty Ltd
Applicant ACN: 000 226 022
Summary of Variation: To extend the use to additional vegetable crops and chia for control of lepidopteran pests
Date of Variation: 9 November 2012
Label Approval No: 61223/55829
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 9
Notice of Registrations - Agricultural Chemical Products
Product Name: EzyCrop Paraquat-Diquat 250 Herbicide
Active Constituent/s: 115g/L diquat present as diquat dibromide, 135g/L paraquat present as paraquat dichloride
Applicant Name: Ezycrop Pty Ltd
Applicant ACN: 156 476 827
Summary of Use: For the control of a wide range of grasses and broadleaf weeds
Date of Registration: 12 November 2012
Label Approval No: 68075/57436
Product Name: 4Farmers Fluroxypyr 200 Herbicide
Active Constituent/s: 200g/L fluroxypyr present as the methylheptyl ester
Applicant Name: 4 Farmers Pty Ltd
Applicant ACN: 067 443 485
Summary of Use: For the control of broadleaf weeds in fallow, lucerne, maize, millets, pastures, poppies, sorghum, sugarcane, sweetcorn and winter cereals. Also for the control of woody weeds in agricultural non-crop areas, commercial and industrial areas, forests, pastures and rights -of-way
Date of Registration: 12 November 2012
Label Approval No: 68134/57584
Product Name: Wellfarm Glyphosate 450 Herbicide
Active Constituent/s: 450g/L glyphosate present as the isopropylamine salt
Applicant Name: Wellfarm Proprietary Limited
Applicant ACN: 158 518 551
Summary of Use: For non-selective control of many annual and broadleaf weeds and plants
Date of Registration: 12 November 2012
Label Approval No: 68153/57638
Product Name: Trio Stomp Glyphosate 510 Herbicide
Active Constituent/s: 510g/L glyphosate present as the isopropylamine salt
Applicant Name: Australian Progressive Supplies Pty Ltd
Applicant ACN: 149 848 591
Summary of Use: For use as a non-selective water soluble herbicide for the control of a wide range of annual and perennial weeds in wide variety of situations
Date of Registration: 12 November 2012
Label Approval No: 68148/57632
Product Name: Imtrade Edge 900 WG Herbicide
Active Constituent/s: 900g/kg propyzamide
Applicant Name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of Use: For the selective control of certain grasses and broadleaf weeds in lettuce, sports turf, home lawns and legume seed crops and pastures
Date of Registration: 12 November 2012
Label Approval No: 63332/46615
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 10
Notice of Registrations - Agricultural Chemical Products
Product Name: FMC Pendimethalin 435 Herbicide
Active Constituent/s: 435g/L pendimethalin
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For the control of certain broadleaf weeds in various crops
Date of Registration: 12 November 2012
Label Approval No: 68175/57698
Product Name: ChemAg Edge 900 WG Herbicide
Active Constituent/s: 900g/kg propyzamide
Applicant Name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of Use: For the selective control of certain grasses and broadleaf weeds in lettuce, sport turf, home lawns, legume seed crops and pastures
Date of Registration: 12 November 2012
Label Approval No: 61323/47808
Product Name: Spalding Perforator Spraying Oil
Active Constituent/s: 120g/L nonyl phenol ethoxylate, 120g/L alcohol ethoxylate, 582g/L paraffinic oil
Applicant Name: Spalding Holdings Pty. Ltd.
Applicant ACN: 010 155 852
Summary of Use: To improve the spreading and wetting of herbicides, insecticides and defoliants on plant surfaces
Date of Registration: 12 November 2012
Label Approval No: 68160/57659
Product Name: Farmalinx 2,4-D LV Ester 450 Herbicide
Active Constituent/s: 450g/L 2,4-D present as the 2-ethylhexyl ester
Applicant Name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of Use: For selective control of various weeds in crops, pastures and non-agricultural areas
Date of Registration: 13 November 2012
Label Approval No: 68007/57263
Product Name: Homebrand Granular Pool Chlorine Superchlorinator And Shock Treatment
Active Constituent/s: 700g/kg chlorine (Cl) present as calcium hypochlorite
Applicant Name: Hy-Clor (Australia) Pty Ltd
Applicant ACN: 000 655 381
Summary of Use: For the control of bacteria and algae in swimming pools
Date of Registration: 13 November 2012
Label Approval No: 67501/56204
Product Name: Titan Epoxiconazole 500 WDG Fungicide
Active Constituent/s: 500g/kg epoxiconazole
Applicant Name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of Use: For control of stripe rust in wheat and powdery mildew in barley
Date of Registration: 13 November 2012
Label Approval No: 65576/51341
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 11
Notice of Registrations - Agricultural Chemical Products
Product Name: Traildim 400WG Herbicide
Active Constituent/s: 400g/kg tralkoxydim
Applicant Name: Hextar Chemicals Pty Ltd
Applicant ACN: 114 525 709
Summary of Use: For the control of wild oats and annual ryegrass and suppression of annual phalaris in wheat, barley, rye and triticale
Date of Registration: 13 November 2012
Label Approval No: 68124/57565
Product Name: Piclor M 242 Herbicide
Active Constituent/s: 26g/L picloram present as the potassium salt, 420g/L MCPA present as the potassium salt
Applicant Name: eChem (Aust) Pty Limited
Applicant ACN: 089 133 095
Summary of Use: For the control of climbing buckwheat, common sowthistle, skeleton weed, capeweed, doublegee and broadleaf weeds in winter cereals and linseed crops
Date of Registration: 13 November 2012
Label Approval No: 66955/54810
3. VARIATIONS
Product Name: Mark-It
Applicant Name: SST Australia Pty. Ltd.
Applicant ACN: 052 845 833
Summary of Variation: To change the product name from ‘SST PRODUCTS MARK-IT LIQUID MARKING DYE’ to ‘MARK-IT’ and to add 20L, 110L and 200L pack sizes
Date of Variation: 1 November 2012
Label Approval No: 53962/57163
Product Name: Terminade Residual Termiticide
Applicant Name: PCT Holdings Pty Ltd
Applicant ACN: 099 023 962
Summary of Variation: To vary the registration and label particulars to include additional uses in pre-constructions situations, reticulation systems, poles, trees and wall cavities
Date of Variation: 1 November 2012
Label Approval No: 63502/57631
Product Name: Smart Flow 450 Herbicide
Applicant Name: Crop Smart Pty Ltd
Applicant ACN: 093 927 961
Summary of Variation: To change the product name from ‘SMART LOADED 450 HERBICIDE’ to ‘SMART FLOW 450 HERBICIDE’
Date of Variation: 1 November 2012
Label Approval No: 64892/57880
Product Name: Warden Residual Termiticide
Applicant Name: Farmoz Pty Limited
Applicant ACN: 050 328 973
Summary of Variation: To change the product name from ‘TAURUS RESIDUAL TERMITICIDE’ to ‘WARDEN RESIDUAL TERMITICIDE’
Date of Variation: 2 November 2012
Label Approval No: 67463/57904
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 12
Notice of Registrations - Agricultural Chemical Products
Product Name: Titan Clethodim 240 Herbicide
Applicant Name: Titan AG Pty Ltd
Applicant ACN: 122 081 574
Summary of Variation: To add directions for use in pulses and pasture legumes
Date of Variation: 2 November 2012
Label Approval No: 62806/55426
Product Name: Mentor WG Herbicide
Applicant Name: Farmoz Pty Limited
Applicant ACN: 050 328 973
Summary of Variation: To change product name from FARMOZ MENTOR WG HERBICIDE to MENTOR WG HERBICIDE
Date of Variation: 7 November 2012
Label Approval No: 60889/57406
Product Name: Coles Flying Insect Killer Spray Low Allergenic
Applicant Name: Pascoe's Pty Ltd
Applicant ACN: 055 220 463
Summary of Variation: To change the product name from COLES FLYING INSECT SPRAY LOW ALLERGENIC to COLES FLYING INSECT KILLER SPRAY LOW ALLERGENIC
Date of Variation: 13 November 2012
Label Approval No: 67587/57546
Product Name: Crystal Waters Pool Sanitiser
Applicant Name: M I International Pty Ltd
Applicant ACN: 002 869 089
Summary of Variation: To change the product name from POOL SPARKLE POOL SANITISER to CRYSTAL WATERS POOL SANITISER and update the RLP
Date of Variation: 13 November 2012
Label Approval No: 66943/57122
Product Name: Companion Surfactant
Applicant Name: SST Australia Pty. Ltd.
Applicant ACN: 052 845 833
Summary of Variation: To change product name from SST PRODUCTS COMPANION SURFACTANT to COMPANION SURFACTANT
Date of Variation: 7 November 2012
Label Approval No: 51664/57388
Product Name: Destiny Selective Turf Herbicide
Applicant Name: Bayer Cropscience Pty Ltd
Applicant ACN: 000 226 022
Summary of Variation: To extend the use to include Bahia Grass (Paspalum notatum) as an additional weed under existing situations of turf
Date of Variation: 8 November 2012
Label Approval No: 56801/56696
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 13
Notice of Registrations - Agricultural Chemical Products
Product Name: Turf Culture Thumper Miticide & Nematicide
Applicant Name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of Variation: To change the product name from TURF CULTURE THUMPER MITICIDE
to TURF CULTURE THUMPER MITICIDE & NEMATICIDE and to extend RLP's to include control of soil borne parasitic nematodes in turf
Date of Variation: 8 November 2012
Label Approval No: 63594/54377
Product Name: Grow-Phos 600 Systemic Fungicide
Applicant Name: Easy Clean Chemicals Pty. Ltd.
Applicant ACN: 006 184 050
Summary of Variation: To include control of downy mildew in poppies
Date of Variation: 8 November 2012
Label Approval No: 65824/57907
Product Name: Smart Clopyralid 750 SG Herbicide
Applicant Name: Crop Smart Pty Ltd
Applicant ACN: 093 927 961
Summary of Variation: To change the product name from SMART CLOPYRALID 750 WG HERBICIDE to SMART CLOPYRALID 750 SG HERBICIDE as requested by the APVMA
Date of Variation: 12 November 2012
Label Approval No: 67703/58134
Product Name: Py-Bo Natural Pyrethrum Insecticidal Concentrate
Applicant Name: Pestech Australia Pty Ltd
Applicant ACN: 003 536 589
Summary of Variation: To extend use to include control of a range of insects in household and garden situations.
Date of Variation: 7 November 2012
Label Approval No: 53738/54292
Product Name: Permatek IM 30 Insecticide
Applicant Name: Zelam Pty Ltd
Applicant ACN: 082 428 028
Summary of Variation: To extend the RLP claims to include control of termites in softwood LVL and plywood
Date of Variation: 14 November 2012
Label Approval No: 54645/56435
Product Name: Farmozine 900 WG Herbicide
Applicant Name: Farmoz Pty Limited
Applicant ACN: 050 328 973
Summary of Variation: To change product name from ‘FARMOZ FARMOZINE 900 WDG HERBICIDE ’ to ‘FARMOZINE 900 WG HERBICIDE’
Date of Variation: 14 November 2012
Label Approval No: 46810/57402
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 14
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.
1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Purina Total Care Intestinal Allwormer Tablets For Puppies And Small Dogs 0.5-5kg
Active Constituent/s: 2.5 mg/Tablet milbemycin oxime, 25mg/Tablet praziquantel
Applicant Name: Novartis Animal Health Australasia Pty. Limited
Applicant ACN: 076 745 198
Summary of Use: For the control of gastrointestinal worms in puppies and small dogs 0.5-5kg body weight
Date of Registration: 31 October 2012
Label Approval No: 66907/54668
Product Name: Purina Total Care Intestinal Allwormer Tablets For Dogs Over 5kg
Active Constituent/s: 12.5mg/Tablet milbemycin oxime, 125mg/Tablet praziquantel
Applicant Name: Novartis Animal Health Australasia Pty. Limited
Applicant ACN: 076 745 198
Summary of Use: For the control of gastrointestinal worms in dogs greater than 5kg body weight
Date of Registration: 31 October 2012
Label Approval No: 66905/54665
Product Name: Scalibor 3 Month Paralysis Tick Collar For Small Dogs
Active Constituent/s: 40g/kg deltamethrin
Applicant Name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of Use: For the control of paralysis tick (Ixodes holocyclus) for up to 14 weeks and brown dog tick (Rhipicephalus sanguineus) for up to 26 weeks on dogs
Date of Registration: 31 October 2012
Label Approval No: 65355/50747
Product Name: Neove Flunixin Meglumine Injection
Active Constituent/s: flunixin meglumine (equivalent to 50mg/mL flunixin)
Applicant Name: Neove Pharma Australia Pty Limited
Applicant ACN: 140 367 442
Summary of Use: For use in the alleviation of inflammation and pain associated with musculoskeletal disorders, visceral pain and inflammation associated with colic, also as aids in the normalisation of peristalsis for equines. For use in the management of acute respiratory diseases and ‘downer cow’ syndrome in bovines. For use in the treatment of mastitis, metritis, agalactia syndrome (MMA or lactational failure) in swine. For use in the supportive therapy of arthritis, heat stroke and accident cases in canines
Date of Registration: 1 November 2012
Label Approval No: 67178/55400
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 15
Notice of Registrations - Veterinary Chemical Products
Product Name: Medetate Injection
Active Constituent/s: 1mg/mL medetomidine hydrochloride
Applicant Name: Jurox Pty Limited
Applicant ACN: 000 932 230
Summary of Use: For use as a sedative and analgesic in the restraint of dogs and cats
Date of Registration: 6 November 2012
Label Approval No: 65829/52129
Product Name: Tickstar Pour-On Tick Development Inhibitor
Applicant Name: The Hunter River Company Pty Limited
Applicant ACN: 133 798 615
Summary of Variation: To change the product name from ‘TICKOFF POUR-ON TICK DEVELOPMENT INHIBITOR’ to ‘TICKSTAR POUR-ON TICK DEVELOPMENT INHIBITOR’
Date of Variation: 7 November 2012
Label Approval No: 65325/58087
Product Name: Anthrax Vaccine (Living Spore Sterne 34F2 Strain)
Active Constituent/s: Contains not less than 5x106/mL of living spores of Bacillus anthracis (Sterne 34F2 strain)
Applicant Name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of Use: For active immunisation of sheep, cattle and pigs against anthrax disease caused by Bacillus anthracis
Date of Registration: 8 November 2012
Label Approval No: 68127/57568
Product Name: Meloxidyl 1.5 mg/mL Oral Suspension For Dogs
Active Constituent/s: 1.5mg/mL meloxicam
Applicant Name: Ceva Animal Health Pty Ltd
Applicant ACN: 002 692 426
Summary of Use: For the alleviation of inflammation and pain in both acute and chronic musculoskeletal conditions in dogs
Date of Registration: 14 November 2012
Label Approval No: 63250/45161
2. VARIATIONS
Product Name: Nobilis ILT Vaccine
Applicant Name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of Variation: To change the product name from INTERVET NOBILIS ILT VACCINE to NOBILIS ILT VACCINE
Date of Variation: 14 November 2012
Label Approval No: 59802/56483
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 16
`* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices - Cancellation of Product Registrations at the Request of the Registrant
OTHER NOTICES
Licensing of Veterinary Chemical Manufacturers
Pursuant to Part 8 of the Agricultural and Veterinary Chemical Codes scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has taken action, with respect to the licensing of the following veterinary chemical manufacturers, with effect from the dates shown.
For a comprehensive listing of all licensed manufacturers please see the APVMA’s website www.apvma.gov.au.
1. CHANGES TO EXISTING LICENCES
COSMETIC MANUFACTURERS
(AUST) PTY. LTD.
LICENCE NO: 2176
ACN: 010 501 327
14 Kingston Drive
HELENSVALE QLD 4212
Product Types: *
Category 2: Creams/lotions, sprays, liquids, gels and ointments.
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, filling, packaging, labelling and release for supply.
Amended Licence Issued: 11/10/2012
Amendment to key personnel, product types and address details.
REDOX PTY LTD LICENCE NO: 6065
ACN: 000 762 345
26-30 Gilbertson Road
LAVERTON NORTH VIC 3026
Product Types: *
Category 6: Single step
Step(s) of Manufacture: Labelling, storage and release for supply.
Amended Licence Issued: 03/10/2012
Amendment to key personnel.
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 17
`* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices - Cancellation of Product Registrations at the Request of the Registrant
PACKAGING
PROFESSIONALS PTY LTD
LICENCE NO: 6111
ACN: 096 824 850
2-4 Wembley Place
KELSO NSW 2795
Product Types: *
Category 6: Single step manufacture
Step(s) of Manufacture: Packaging, labelling, strip, blister or sachet packaging,
storage and release for supply.
Amended Licence Issued: 05/10/2012
Amendment to key personnel.
SILLIKER AUSTRALIA PTY.
LTD.
LICENCE NO: 6006
ACN: 006 462 335
18-20 King Street
BLACKBURN VIC 3130
Product Types: *
Category 6: Single step manufacture
Step(s) of Manufacture: Analysis and testing (Physical, chemical,
microbiological and sterility test).
Amended Licence Issued: 11/10/2012
Amendment to key personnel and manufacturing steps.
SPHERE HEALTHCARE PTY.
LIMITED
LICENCE NO: 2187
ACN: 054 309 705
10-12 Church Street
MOOREBANK NSW 2170
Product Types: *
Category 2: Tablets, pellets, capsules, capsules (soft gelatine), creams/lotions, ointments, pastes, powders, liquids and suspensions.
Category 4: Premixes, supplements and probiotics
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, dry milling of powders, wet milling of powders, granulation,
filling, packaging, labelling, strip, blister or sachet packaging, soft gelatine capsule
manufacture, tableting, tablet coating, capsule filling from bulk, analysis and
testing (physical, chemical), storage and release for supply.
Amended Licence Issued: 12/10/2012
Change of key personnel and licence conditions.
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 18
`* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices - Cancellation of Product Registrations at the Request of the Registrant
TASMAN CHEMICALS PTY.
LIMITED
LICENCE NO: 2170
ACN: 005 072 659
1-7 Bell Grove
BRAESIDE VIC 3195
Product Types: *
Category 2: liquids and ointments
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, filling, packaging, labelling, analysis and testing (physical and
chemical), storage and release for supply.
Amended Licence Issued: 03/10/2012
Amendment to product types.
VIRBAC (AUSTRALIA) PTY
LTD
LICENCE NO: 6137
ACN: 003 268 871
361 Horsley Road
MILPERRA NSW 2214
Product Types: *
Category 6: Single step manufacture
Step(s) of Manufacture: Quality assurance (QA) of raw materials, secondary
packaging, repackaging, relabelling, secondary/supplementary labelling, analysis
and testing (physical and chemical), storage and release for supply.
Amended Licence Issued: 15/10/2012
Change of key personnel.
ARUMPO BENTONITE PTY
LIMITED
LICENCE NO: 4065
ACN: 001 831 483
Arumpo Road
BURONGA NSW 2739
Product Types: *
Category 4: supplements (bentonite)
Step(s) of Manufacture: Quality assurance (QA) of raw materials, filling,
packaging, labelling, analysis and testing (physical and chemical), storage and
release for supply.
Amended Licence Issued: 12/10/2012
Change of key personnel, amended steps of manufacture and update of
conditions.
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 19
`* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices - Cancellation of Product Registrations at the Request of the Registrant
INTEGRIA HEALTHCARE
(BALLINA) PTY LTD
LICENCE NO: 3009
ACN: 002 833 141
Pacific Highway
BALLINA NSW 2478
Product Types: *
Category 3: shampoos, insect repellents
Step(s) of Manufacture: Filling, packaging, labelling, storage and release for
supply.
Amended Licence Issued: 11/10/2012
Changes to key personnel.
INTEC CORPORATION PTY
LTD
LICENCE NO: 1050
ACN: 087 935 046
8 Mosrael Place
ROWVILLE VIC 3178
Product Types: *
Category 1: Sterile Products
Category 2: Liquids
Category 3: Liquids
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, filling, packaging, labelling, aseptic filling, sterilisation (heat
and filtration), analysis and testing (physical), storage and release for supply.
Amended Licence Issued: 23/10/2012
Change to licence conditions.
HOSPIRA AUSTRALIA PTY
LTD
LICENCE NO: 1067
ACN: 097 064 330
1-5, 2-10, 7-23, 25-39 Lexia
Place
MULGRAVE VIC 3170
Product Types: *
Category 1: Sterile Products
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, filling, packaging, labelling, sterilisation (heat and filtration),
microbiological reduction treatment (heat and filtration), analysis and testing
(physical, chemical, microbiological and limulus amoebocyte lysate test [LAL]),
storage and release for supply.
Amended Licence Issued: 17/10/2012
Variation to key personnel, address details and update of conditions.
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 20
`* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices - Cancellation of Product Registrations at the Request of the Registrant
JUROX PTY LIMITED LICENCE NO: 1042
ACN: 000 932 230
85 Gardiner Street
RUTHERFORD NSW 2320
Product Types: *
Category 1: Sterile Products
Category 2: Tablets, creams/lotions, ointments, pastes, powders, sprays and liquids
Category 3: Liquids, pastes, sprays and powders
Step(s) of Manufacture: Quality assurance (QA) of raw materials, chemical
synthesis, formulation including blending, granulation, filling, aseptic filling,
packaging, labelling, strip, blister or sachet packaging, tableting, tablet coating,
sterilisation (heat and filtration), microbiological reduction treatment (heat and
filtration), analysis and testing (physical, chemical, Limulus Amoebocyte Lysate
(LAL) test, sterility test and microbiological), storage and release for supply.
Amended Licence Issued: 25/10/2012
Minor amendment to address.
AUSVETLAB PTY LTD,
TRADING AS
AUSTRALIAN
VETERINARY SERUM
LABORATORIES, AS
TRUSTEE FOR DAVID K
JONES FAMILY
SETTLEMENT
LICENCE NO: 1063
ACN: 001 611 516
105 Norman Jones Lane
ALSTONVILLE NSW
2477
Product Types: *
Category 1: Immunobiologicals (tick antiserum and snake antivenoms)
Step(s) of Manufacture: Quality assurance (QA) of raw materials, serum
collection, management and immunisation of donor animals, formulation including
blending, aseptic filling, sterilisation (heat and filtration), microbiological reduction
treatment (heat and filtration), packaging, labelling, analysis and testing
(physical), storage and release for supply.
Amended Licence Issued: 26/10/2012
Amendments to address details and conditions.
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 21
`* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices - Cancellation of Product Registrations at the Request of the Registrant
2. LICENCE CANCELLATIONS
The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’].
NOVARTIS ANIMAL HEALTH
AUSTRALASIA PTY LIMITED
LICENCE NO: 6126
ACN: 076 745 198
Unit 1, 1 Dupas Street
SMITHFIELD NSW 2164
Date Cancelled: 10/10/2012
Reason for Cancellation: S127(1)(d) and s127(1)(e)
PHARMASCOPE PTY LTD LICENCE NO: 2212
ACN: 111 664 674
7 Kalgan Road
WELSHPOOL WA 6106
Date Cancelled: 10/10/2012
Reason for Cancellation: S127(1)(d)
CHEMIKA PTY LIMITED LICENCE NO: 6073
ACN: 093 373 534
Level 1/16 Rowood Road
PROSPECT NSW 2148
Date Cancelled: 10/10/2012
Reason for Cancellation: S127(1)(d)
A.G.M. FOODS PTY. LTD
ACN: 080 343 513
106 Berrima Street
WYNNUM QLD 4178
LICENCE NO: 4077
Date Cancelled: 10/10/2012
Reason for Cancellation: S127(1)(d) and s127(1)(e)
LIVESTOCK NUTRITION
TECHNOLOGIES PTY LTD
LICENCE NO: 2165
ACN: 060 272 068
381-385 Woolcock Street
GARBUTT QLD 4814
Date Cancelled: 25/10/2012
Reason for Cancellation: s127(1)(e)
APVMA CONTACT
Riannon Cuschieri
GMP Officer
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4899
Fax: +61 2 6210 4741
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 22
Other Notices - Cancellation of Product Registrations at the Request of the Registrant
Cancellation of Product Registrations at the Request of the Registrant
In accordance with Section 42 of the Agvet Code, if an interested or approved person in relation to an approval or registration has given to the APVMA a written notice requesting the APVMA to cancel the below approval or registration, the APVMA must give written notice of its decision on the request to the person(s) who made the request.
This Gazette notice satisfies the requirement in section 45A (1) of the Agvet Code, that the APVMA must also give notice to any other person to whom, in its opinion such a notice should be given.
At the request of the registrant, the APVMA has cancelled the registrations of the following products:
Product No. Product Name Registrant Date of Effect
51815 SUMMIT SUM-ESTER 800 L
HERBICIDE
SUMMIT AGRO AUSTRALIA PTY
LTD
7 November 2012
59215 ARM 2,4-D ESTER 800 HERBICIDE AUSTRALIAN RURAL
MARKETING PTY LTD
7 November 2012
Note: The APVMA is advised that these products have not been supplied for many years and are unlikely to have product available in the supply chain or held by users.
The following instructions set out how a person can deal with the cancelled products.
SUPPLY
A person may supply or cause to be supplied products manufactured prior to 7 November 2012 at wholesale and retail level, until 7 November 2014, in accordance with PER13339.
After 7 November 2014 it will be an offence against the Agvet Codes to have possession or custody of the products with the intention to supply the products.
USE
A person may continue to use the products in accordance with PER13339 until 7 November 2014.
Any person who possesses, has custody of, uses, or otherwise deals with the listed products 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 products after the registrations have been cancelled until 7 November 2014.
The supply and use of the products must be in accordance with the label instructions, 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 products 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: +61 2 6210 4749
Fax: +61 2 6210 4776
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 23
Other Notices - Amendments to the APVMA MRL Standard—Outcomes of Review Decisions
Amendments to the APVMA MRL Standard—Outcomes of Review Decisions
The Australian Pesticides and Veterinary Medicines Authority (APVMA) establishes maximum residue limits
(MRLs) of agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food
chain. The MRLs established 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 MRL Standard
published by the APVMA. 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 or use 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 MRL Standard is accessible via the APVMA website www.apvma.gov.au.
The APVMA has varied the MRL Standard as set out below as an outcome of the review of fenthion with
effect from the date of this notice.
For further information please contact:
Residues Contact Officer
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4837
Fax: +61 2 6210 4840
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 24
Other Notices - Amendments to the APVMA MRL Standard—Outcomes of Review Decisions
AMENDMENT No. 5PR, 2012
Note: ‘*’ denotes that the maximum residue limit (MRL) has been set at or about the limit of analytical
quantitation (see: Residue Guideline No.4, Maximum Residue Limit Proposals ‘At or about the Limit of
Analytical Quantitation’, published in NRA Gazette No.9, p44, 5/9/95).
‘T’ denotes that the MRL, residue definition or use is temporary. These temporary MRLs will be subject to
further consideration during the period of suspension of fenthion products.
TABLE 1: MAXIMUM RESIDUE LIMITS OF PESTICIDES, AGRICULTURAL CHEMICALS, FEED
ADDITIVES, VETERINARY MEDICINES AND ASSOCIATED SUBSTANCES IN FOOD
COMMODITIES
Residues of substances which may occur in food commodities and for which the following maximum residue
limits (MRLs) apply.
COMPOUND FOOD MRL (mg/kg)
Fenthion
DELETE:
FC 0001 Citrus fruits 2
FT 0297 Fig 2
VC 0045 Fruiting vegetables, Cucurbits 3
VO 0050 Fruiting vegetables, other than Cucurbits 5
FB 0269 Grapes 2
FT 0336 Guava 2
FT 0305 Olives T1
OC 0305 Olive oil, crude T3
FT 0307 Persimmon, Japanese 2
FP 0009 Pome fruits 2
FS 0012 Stone fruits 5
ADD:
FS 0240 Apricot T0.20
FS 0013 Cherries T0.40
FC 0001 Citrus fruits T0.7
FB 0269 Grapes T0.2
VC 0046 Melons, except Watermelon T3
FS 0245 Nectarine T0.25
FT 0305 Olives T0.2
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 25
Other Notices - Amendments to the APVMA MRL Standard—Outcomes of Review Decisions
COMPOUND FOOD MRL (mg/kg)
OC 0305 Olive oil, crude T0.5
FS 0247 Peach T0.20
VO 0444 Peppers, Chili T7
Peppers, Chili, other cultivars T7
VO 0445 Peppers, Sweet [capsicums] T0.5
FT 0307 Persimmon, Japanese T0.3
FS 0014 Plums T0.25
FP 0009 Pome fruits T0.25
VC 0432 Watermelon T3
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 26
Other Notices - Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade
Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade
NOTICE OF REQUEST FOR
INFORMATION IN REGARD TO THE
POTENTIAL LISTING OF THREE NEW
CHEMICALS IN ANNEX III OF THE
ROTTERDAM CONVENTION
Notice is hereby given that the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade sixth meeting of the Conference of the Parties (COP) on 28 April to 11 May 2013 will consider the listing of three new pesticides in Annex III (http://www.pic.int/):
1. azinphos-methyl;
2. trichlorfon; and
3. severely hazardous pesticide formulations of paraquat dichloride (only emulsifiable concentrate and soluble concentrate liquid formulations of 276 g active ingredient/L or above, corresponding to paraquat ion at 200 g/L or above).
The export of chemicals currently listed in Annex III of the Rotterdam Convention requires written permission from the Australian Government Department of Agriculture, Fisheries and Forestry (DAFF). Permission will be granted if the export meets the requirements of the importing party and the following requirements are met:
the importing country is a party to the convention, or
the chemical is controlled under the convention as a severely hazardous pesticide formulation, but the formulation to be exported is at a lower concentration.
For further information on export permit requirements or to make an online application, please visit http://www.daff.gov.au/agriculture-food/ag-vet-chemicals/stockholm-rotterdam. There is no fee for applications of this type.
Your feedback is requested
The Australian Government Department of Sustainability, Environment, Water, Population and Communities (DSEWPaC) is currently assessing how Australian companies would be impacted by export obligations that would apply if these chemicals are listed under the Convention and inserted into Australian legislation.
To this end, the following information is sought and should be provided to the APVMA by COB 14 December 2012
1. Have you or your company ever exported or intend to export azinphos-methyl, trichlorfon and/or paraquat dichloride (at any concentration)?
2. If Yes, please provide
a. The frequency and quantity exported in the last 12 months.
b. The frequency and /quantity expected to be exported annually in the future.
3. Any other relevant information you may wish to provide.
Please note that any data provided will be treated as commercially confidential information.
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 27
Other Notices - Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade
Please forward your response to the:
Pesticides Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604
Phone: +61 2 6210 4748
Fax: +61 2 6210 4776
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 28
Other Notices - Interim Pesticide and Veterinary Medicines Product Sales 11/12 Financial Year
Interim Pesticide and Veterinary Medicines Product Sales 2011-12 Financial Year
This notice provides the collated interim product sales information provided to the APVMA for the 2011-12 financial year. The information includes product sales declarations received up until 19 November 2012. The interim information comprises 97.7% of all veterinary products and 97.4% of all agricultural products. In total the APVMA has received 97.55% of product sales / disposals declarations. A further and final notice of product sales data for the 2011-12 Financial Year will be gazetted in March 2013.
AGRICULTURAL (PESTICIDES) PRODUCT SALES FOR THE 2011-12 FINANCIAL YEAR
Agricultural Product Types No of Products Total $
ADJUVANTS/SURFACTANTS 375 83,504,489.36
ANTIFOULING - BOAT 44 17,717,452.00
DAIRY CLEANSER 150 11,416,126.12
DISINFECTANT/SANITISER 91 9,507,719.93
FUNGICIDE 703 218,104,116.02
GROWTH PROMOTERS/REGULATORS 205 38,271,832.68
HERBICIDE 2420 1,302,745,706.47
HOUSEHOLD INSECTICIDE 545 131,471,960.88
INSECTICIDE 1166 425,792,510.59
MISC 27 2,439,747.44
MISCELLANEOUS 38 2,761,505.77
MITICIDE 103 20,938,207.62
MIXED FUNCTION PESTICIDE 138 26,941,119.25
MOLLUSCICIDE 50 16,655,588.97
NEMATICIDE 19 3,497,287.80
POOL PRODUCTS/ALGICIDE 759 55,488,825.59
REPELLENT - DOGS/BIRDS ETC 25 1,322,257.68
SEED TREATMENTS 162 39,299,394.50
VERTEBRATE POISON 157 30,171,605.06
WOOD PRESERVATIVE 112 48,606,824.41
GRAND TOTAL 7289 2,486,654,278.14
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 29
Other Notices - Interim Pesticide and Veterinary Medicines Product Sales 11/12 Financial Year
VETERINARY MEDICINES PRODUCT SALES FOR THE 2011-12 FINANCIAL YEAR
Veterinary Product Types No of Products Total $
ALIMENTARY SYSTEM ANTI BLOAT 17 3,975,150.61
ALIMENTARY SYSTEM
ANTIDIARRHOEALS AND SCOUR
TREATMENTS 17 1,543,357.93
ALIMENTARY SYSTEM
LAXATIVES, PURGATIVES,
LUBICANTS, ANTISPAMODICS 13 2,847,209.33
ANAESTHETICS/ANALGESICS
ANAESTHETICS - LOCAL AND
GENERAL 48 9,836,631.47
ANAESTHETICS/ANALGESICS ANALGESICS 18 3,277,341.47
ANTIBIOTIC & RELATED ANTIBIOTIC - INTRAMAMMARY 27 11,677,170.11
ANTIBIOTIC & RELATED ANTIBIOTIC - ORAL 187 25,616,282.44
ANTIBIOTIC & RELATED ANTIBIOTIC - PARENTERAL 80 23,412,550.18
ANTIBIOTIC & RELATED OTHER ANTI-INFECTIVE AGENTS 50 1,899,188.32
ANTIBIOTIC & RELATED SULFONAMIDES 43 2,775,408.00
ANTIDOTES ANTIDOTES 13 1,285,754.74
CARDIOVASCULAR SYSTEM
CARDIAC REACTANTS, CLOTTING
AGENTS 40 7,802,858.67
CENTRAL NERVOUS SYSTEM
HYPNOTICS, TRANQUILIZERS,
EMETICS, ANTIEMETICS 43 3,472,721.13
DERMATOLOGICAL PREPS.
ANTIBIOTICS, ANTIFUNGALS,
CORTICOSTEROID COMBINATIONS 36 1,820,055.95
DERMATOLOGICAL PREPS.
ANTISEPTICS (DERMATOLOGICAL
AND GENERAL) 152 22,352,879.01
DERMATOLOGICAL PREPS. GROOMING AIDS 7
204,483.54
DERMATOLOGICAL PREPS.
NONSTEROIDAL ANTIPRURITICS,
KERATOLYICS 36 5,745,990.45
EAR,NOSE,THROAT PREPS. AURAL 30 4,622,151.27
ENDOCRINE SYSTEM ANABOLIC STEROIDS 27 1,322,559.45
ENDOCRINE SYSTEM
CORTICOSTEROIDS AND ADRENAL
COMPOUNDS 34 2,921,672.99
ENDOCRINE SYSTEM SEX HORMONES 57 7,497,240.22
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 30
Other Notices - Interim Pesticide and Veterinary Medicines Product Sales 11/12 Financial Year
Veterinary Product Types No of Products Total $
ENDOCRINE SYSTEM
TROPHIC HORMONES (PITUITARY) &
INSULIN PREPARATIONS 35 6,263,257.33
GENITOURINARY SYSTEM DIURETICS, ACIDIFIERS, ALKANISERS 28 1,767,183.23
GENITOURINARY SYSTEM
UTERINE OR VAGINAL ACTING
AGENTS 8
882,822.78
IMMUNOTHERAPY ANTISERA, ANTIVENOM 11 3,773,189.17
IMMUNOTHERAPY IMMUNOMODIFYING AGENTS 12 3,255,182.40
IMMUNOTHERAPY INJECTABLE VACCINES 177 124,216,850.72
IMMUNOTHERAPY NASAL, ORAL, OPTHALMIC VACCINES 33 23,729,568.09
MISCELLANEOUS VETERINARY MISCELLANEOUS VETERINARY 79 19,493,871.39
MUSCULOSKELETAL SYSTEM ANTI-INFLAMMATORY AGENTS 215 30,220,894.78
MUSCULOSKELETAL SYSTEM
COUNTER-IRRITANTS,
RUBEFACIENTS, POULTICES 21 1,913,128.08
NUTRITION & METABOLISM
ANTIBIOTIC AND ANTI-INFECTIVE
SUPPLEMENTS 43 5,943,618.24
NUTRITION & METABOLISM DIETARY/THERAPEUTIC PET FOODS 118 49,994,844.00
NUTRITION & METABOLISM DIGESTIVE ENZYME SUPPLEMENTS 69 16,485,858.00
NUTRITION & METABOLISM ELECTROLYTES 71 6,102,239.83
NUTRITION & METABOLISM GROWTH PROMOTANTS 72 23,099,465.56
NUTRITION & METABOLISM IRON AND HAEMOPOIETIC AGENTS 23 1,951,101.00
NUTRITION & METABOLISM PROBIOTIC AND PREBIOTIC 20 1,240,692.41
NUTRITION & METABOLISM TONICS, STIMULANTS 13
620,970.07
NUTRITION & METABOLISM
VITAMIN, MINERAL, & NUTRITIONAL
SUPPLEMENTS 240 26,802,583.65
OPHTHALMIC PREPARATIONS OPHTHALMIC PREPARATIONS 23 1,879,980.14
PARASITICIDES BIRDS - EXTERNAL 15
231,513.00
PARASITICIDES BIRDS - INTERNAL 35 2,925,378.49
PARASITICIDES
LARGE & SMALL ANIMALS -
EXTERNAL 20 1,870,859.50
PARASITICIDES LARGE ANIMALS - EXTERNAL 176 99,955,072.05
PARASITICIDES LARGE ANIMALS - INTERNAL 282 62,877,082.63
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 31
Other Notices - Interim Pesticide and Veterinary Medicines Product Sales 11/12 Financial Year
Veterinary Product Types No of Products Total $
PARASITICIDES
LARGE ANIMALS - INTERNAL &
EXTERNAL 85 57,854,946.84
PARASITICIDES SMALL ANIMALS - EXTERNAL 203 95,624,209.93
PARASITICIDES SMALL ANIMALS - INTERNAL 243 80,047,756.75
PARASITICIDES
SMALL ANIMALS - INTERNAL AND
EXTERNAL 13 46,133,985.43
RESPIRATORY SYSTEM
EXPECTORANTS, MUCOLYTICS,
DECONGESTANTS,
BRONCHODILATORS, RESP,
STIMLANTS 24 1,203,350.12
GRAND TOTAL 3382 944,270,122.89
APVMA CONTACT
For further information please contact:
Finance Officer
Corporate Services
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4852
Fax: +61 2 6210 4874
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 32
Other Notices - Application Summaries
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. 22, 6 NOVEMBER 2012
For use in agricultural and/or veterinary chemical products:
Common Name Approval Holder Manufacturer and Site of Manufacture Approval No.
ATRAZINE SHANDONG QIAOCHANG CHEMICAL CO LTD
SHANDONG QIAOCHANG CHEMICAL CO LTD
SOUTH OF XINYONGZI ROAD
BINBEI, BINCHENG DISTRICT
BINZHOU CITY
SHANDONG PROVINCE
CHINA
66874
CARFENTRAZONE-ETHYL MAX(RUDONG) CHEMICALS CO., LTD.
ORIENTAL (LUZHOU) AGROCHEMICALS CO., LTD
XINLE TOWN, NAXI DISTRICT,
LUZHOU CITY,
SICHUAN PROVINCE 646300
CHINA
68094
Clethodim AGPRO IP CO. PTY LTD
SHANDONG WEIFANG RAINBOW CHEMICAL CO., LTD.
1 HAIGANG ROAD
BINHAI ECONOMIC DEVELOPMENT AREA
WEIFANG SHANDONG PROVINCE
PR CHINA
66831
FORCHLORFENURON RONIC INTERNATIONAL PTY LIMITED
RONIC INTERNATIONAL PTY LIMITED
9 HEALES RD
LARA VIC 3212
AUSTRALIA
66651
APVMA CONTACT
For further information please contact:
Application Management and Enquiries
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4701
Fax: +61 2 6210 4721
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 33
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.22, 6 NOVEMBER
2012
Application No. Name
55944 VIRBAC PETCARE PREVENTIC 2 MONTH TICK COLLAR FOR DOGS
56031 MACPHERSONS CALDERA 250 SL HERBICIDE
56676 FENAMIPHOS
56784 RHODIA GLYPHOSATE 600 HERBICIDE
56798 SINOCHEM CASTLE 250SC FUNGICIDE
57057 SIRDAR GLYPHOSATE 360 WEED KILLER
57185 RAINBOW PICLORAM/MCPA HERBICIDE
57191 KDPC MARKER DYE BLUE
57201 GLYPHOSATE-AMMONIUM
57226 RANCONA DIMENSION SEED TREATMENT
57255 FARMALINX TORPEDO HERBICIDE
57412 EARTHCORE GLYPHOSATE 360 WEED KILL
57419 FOSETYL-ALUMINIUM 80WP SYSTEMIC FUNGICIDE
57420 FOSETYL-ALUMINIUM 80WP TURF SYSTEMIC FUNGICIDE
57452 BRODIFACOUM MANUFACTURING CONCENTRATE
57591 CEPHALEXIN 1000 ANTIBIOTIC TABLETS
57672 NOT AVAILABLE
57697 NYORA HERBICIDE
57703 PLATINUM HERBICIDE
57708 FLUMETSULAM
57741 PROMECTIN PLUS MINI ALLWORMER PASTE FOR HORSES (300 KG - 600 KG)
57776 NOVAGUARD PROPICONAZOLE 250 EC FUNGICIDE
57787 STIKA NON-IONIC STICKER-SPREADER
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 34
Other Notices - Application Summaries
Application No. Name
57840 OBESITY MANAGEMENT FELINE
57841 WEIGHT CONTROL DS 30 CANINE
57844 NOT AVAILABLE
57851 RAMBO HERBICIDE
57853 DIVAP 1140 INSECTICIDE
57854 ASULOX SELECTIVE HERBICIDE
57920 NOT AVAILABLE
57923 AGRO-ESSENCE TRALKOXYDIM 400 HERBICIDE
57924 AGRO-ESSENCE HALOXYFOP 520 HERBICIDE
57947 NOT AVAILABLE
57963 MIDAS HERBICIDE
57983 ARSENAL XPRESS HERBICIDE
57985 ADONIS 3UL INSECTICIDE
58045 BASF KUMULUS DF WETTABLE SULPHUR FUNGICIDE SPRAY
58069 PROLONG ULTRA FLY AND LITTER BEETLE INSECTICIDE
58078 FLINT 500 WG FUNGICIDE
51297 NOROSEAL
53965 SPADA HERBICIDE
54096 FORCHLORFENURON
56716 REVERZINE SA INJECTION
56727 MACPHERSON TRIBENURON-METHYL 750 WG HERBICIDE
56900 FMC EPOXICONAZOLE 125 FUNGICIDE
57243 SYNERGY POOL SANITISER
57431 ECO-OIL MITICIDE/INSECTICIDE BOTANICAL OIL READY TO USE
57524 NOT AVAILABLE
57753 AQUATOPIA AUSTRALIA POND ALGAE ELIMINATOR
57802 CHLORMEQUAT CHLORIDE MANUFACTURING CONCENTRAT
58058 OPAL HALOXYFOP 520 HERBICIDE
58059 OPAL CLOPYRALID 300 HERBICIDE
58074 NOT AVAILABLE
58086 NOT AVAILABLE
58100 NOT AVAILABLE
58112 NOT AVAILABLE
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 20 November 2012 Agricultural and Veterinary Chemicals Code Act 1994 35
Other Notices - Application Summaries
Application No. Name
58152 ECOPAR HERBICIDE
A change or correction has been made to the following summaries:
Application No. Product/Active Constituent Name
57698 NOT AVAILABLE
APVMA CONTACT
For further information please contact:
Application Management and Enquiries Team
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4701
Fax: +61 2 6210 4721