No. APVMA 11, Tuesday, 4 June 2013
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 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 2
Commonwealth of Australia 2013
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
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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 as requi red
by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material
issued by the APVMA.
Pursuant to section 53(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications
made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in
quarterly statistical reports.
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mailto:[email protected]://www.apvma.gov.au/http://www.apvma.gov.au/publications/gazette/
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Notice of Registrations 4 Agricultural Chemical Products .............................................................................................................................................. 4 Veterinary Chemical Products .............................................................................................................................................. 11
Notice – New Agricultural Active Constituent 13 Ethanedinitrile ...................................................................................................................................................................... 13
Notice – New Agricultural Chemical Products 15 Ethanedinitrile in the product Sterigas 1000 Fumigant ......................................................................................................... 15
Notice – New Veterinary Chemical Products 18 Carbimazole in the products Vidalta 15 mg Tablets For Cats and Vidalta 10 mg Tablets For Cats ..................................... 18
Other notices 22 Revocation of Suspension of Selected Products Containing 2,4-D ethyl ester and associated Label Approvals ................. 22 Cancellation of Label Approval at the Request of the Registrant ......................................................................................... 23 Cancellation of Product Registration .................................................................................................................................... 29 Addendum to the Record of Approved Active Constituents .................................................................................................. 30 Application Summaries ......................................................................................................................................................... 31
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 4
Notice of Registrations – New 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,
1. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Rainbow 2,4-D 450 SL Herbicide
Active Constituent/s: 450 g/L 2,4-D present as the isopropylamine salt
Applicant Name: Shandong Rainbow International Co., Ltd.
Applicant ACN: N/A
Summary of Use: For the control of emerged broadleaf weeds prior to sowing crops and pastures in conservation tillage situations and for selective weed control in crops and situations
Date of Registration: 15 May 2013
Label Approval No: 68270/57895
Product Name: Amulet Gel Insecticide
Active Constituent/s: 3.73 g/kg fipronil
Applicant Name: BASF Australia Ltd
Applicant ACN: 008 437 867
Summary of Use: For the control of Queensland Fruit Flies in stone fruits except cherries (apricots, nectarines, peaches and plums) and non-fruiting refuge vegetation
Date of Registration: 15 May 2013
Label Approval No: 65533/51144
Product Name: Affix 250 SC Fungicide
Active Constituent/s: 250 g/L azoxystrobin
Applicant Name: United Phosphorus Ltd
Applicant ACN: 066 391 384
Summary of Use: For the control of various diseases of grapes, potatoes, tomatoes, cucurbits, avocados, mangoes, passionfruit and poppies
Date of Registration: 15 May 2013
Label Approval No: 66885/54614
Product Name: EzyCrop Fluazifop 212 Post-Emergence Selective Herbicide
Active Constituent/s: 212 g/L fluazifop-p present as the butyl ester
Applicant Name: EzyCrop Pty Ltd
Applicant ACN: 156 476 827
Summary of Use: For the control of certain grasses in various crops
Date of Registration: 16 May 2013
Label Approval No: 68775/59053
Product Name: OzCrop Asulam 400 SL Selective Herbicide
Active Constituent/s: 400 g/L asulam present as the sodium salt
Applicant Name: OzCrop Pty. Ltd.
Applicant ACN: 160 656 431
Summary of Use: For the control of bracken fern in pastures, grasses in sugarcane and a range of weeds and grasses in crops and pastures
Date of Registration: 16 May 2013
Label Approval No: 68440/58371
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 5
Notice of Registrations – New Agricultural Chemical Products
Product Name: Zodiac Granular Spa Bromine
Active Constituent/s: 510 g/kg available chlorine (Cl) present as sodium dichloroisocyanurate, 150g/kg sodium bromide
Applicant Name: Zodiac Group Australia Pty Ltd
Applicant ACN: 002 641 965
Summary of Use: For the control of bacteria, viruses and algae in spas
Date of Registration: 16 May 2013
Label Approval No: 68638/58808
Product Name: Sunphosate 680 WG Herbicide
Active Constituent/s: 680 g/kg glyphosate present as the mono-ammonium salt
Applicant Name: Zhejiang Xinan Chemical Industrial Group Co.,Ltd
Applicant ACN: N/A
Summary of Use: For the control of many annual and perennial weeds in certain situations
Date of Registration: 16 May 2013
Label Approval No: 68767/59039
Product Name: ACP Clethodim 240 EC Selective Herbicide
Active Constituent/s: 240 g/L clethodim
Applicant Name: Australis Crop Protection Pty Ltd
Applicant ACN: 150 711 185
Summary of Use: For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas, cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans
Date of Registration: 16 May 2013
Label Approval No: 68774/59052
Product Name: Apparent Stockade Insecticide
Active Constituent/s: 250 g/L bifenthrin
Applicant Name: Apparent Pty. Ltd.
Applicant ACN: 143 724 136
Summary of Use: To control insect pests and mites of apricots, bananas, barley, canola, citrus, cotton, faba beans, field pea, grapes, lucerne, lucerne seed crops, lupins, navy beans, nectarines, peaches, pears, plums, subterranean clover, sugarcane, tomatoes and wheat
Date of Registration: 16 May 2013
Label Approval No: 68752/59012
Product Name: Farmalinx GBR ACID Growth Regulant
Active Constituent/s: 100 g/L gibberellic acid
Applicant Name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of Use: For foliar spray application to certain varieties of grapes, citrus and prunes to promote desirable harvest effects
Date of Registration: 17 May 2013
Label Approval No: 68766/59035
Product Name: Sinochem CONVEX 240 EC Selective Herbicide
Active Constituent/s: 240 g/L clodinafop, 60g/L cloquintocet-mexyl
Applicant Name: Sinochem Agro Co., Ltd
Applicant ACN: N/A
Summary of Use: For the control of wild oats, paradoxa grass (annual phalaris), canary grass and annual ryegrass in wheat. Highly active on wild oats and can be mixed with many broadleaf herbicides
Date of Registration: 17 May 2013
Label Approval No: 68722/58957
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 6
Notice of Registrations – New Agricultural Chemical Products
Product Name: Mortein Home Expert Outdoor & Indoor Surface Spray
Active Constituent/s: 0.6 g/L deltamethrin
Applicant Name: Reckitt Benckiser (Australia) Pty Limited
Applicant ACN: 003 274 655
Summary of Use: For the prevention of insect infestations in household situations
Date of Registration: 17 May 2013
Label Approval No: 68777/59060
Product Name: SurePro Granular Insecticide
Active Constituent/s: 2 g/kg bifenthrin
Applicant Name: Sumitomo Chemical Australia Pty Limited
Applicant ACN: 081 096 255
Summary of Use: For the control of certain pests in turf; ants, fleas and ticks in external surrounds of buildings and structures
Date of Registration: 20 May 2013
Label Approval No: 68683/58898
Product Name: Rainbow Difenoconazole 250 EC Fungicide
Active Constituent/s: 250 g/L difenoconazole
Applicant Name: Shandong Rainbow International Co., Ltd.
Applicant ACN: N/A
Summary of Use: For the control of target spot of potatoes and tomatoes, leaf blight of carrots, leaf spot diseases of bananas and husk spot on macadamias as specified in the directions for use table
Date of Registration: 22 May 2013
Label Approval No: 68418/58336
Product Name: EzyCrop Imidacloprid 200 SC Insecticide
Active Constituent/s: 200 g/L imidacloprid
Applicant Name: EzyCrop Pty Ltd
Applicant ACN: 156 476 827
Summary of Use: For use in certain vegetables and turf for the control of various insect pests
Date of Registration: 22 May 2013
Label Approval No: 68673/58873
Product Name: Marque Mega Shock Granular Pool Chlorine
Active Constituent/s: 700 g/kg available 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: 22 May 2013
Label Approval No: 68747/59007
Product Name: Mortein Home Expert Outdoor Barrier Spray
Active Constituent/s: 0.3 g/kg imiprothrin, 0.6 g/kg deltamethrin
Applicant Name: Reckitt Benckiser (Australia) Pty Limited
Applicant ACN: 003 274 655
Summary of Use: For control of cockroaches, ants, spiders, slaters, flies, mosquitoes and wasps in household situations
Date of Registration: 22 May 2013
Label Approval No: 68753/59013
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 7
Notice of Registrations – New Agricultural Chemical Products
Product Name: Apparent Insect & Spider Spray Insecticide
Active Constituent/s: 10 g/L deltamethrin
Applicant Name: Apparent Pty. Ltd.
Applicant ACN: 143 724 136
Summary of Use: For the control of a range of insect pests in various situations
Date of Registration: 23 May 2013
Label Approval No: 68748/59008
Product Name: Eradicate Snail and Slug Killer
Active Constituent/s: 60 g/kg iron EDTA complex
Applicant Name: Wattleglen Projects Pty. Limited
Applicant ACN: 006 151 168
Summary of Use: For control of snails and slugs in a range of situations in agriculture and horticulture
Date of Registration: 23 May 2013
Label Approval No: 68634/58804
Product Name: Dantop Systemic Insecticide
Active Constituent/s: 200 g/L clothianidin
Applicant Name: Sumitomo Chemical Australia Pty Limited
Applicant ACN: 081 096 255
Summary of Use: For the control of aphids and mirids on cotton, and rust thrips and weevil borer on bananas
Date of Registration: 23 May 2013
Label Approval No: 68773/59051
Product Name: FMC MCPA + Picloram Herbicide
Active Constituent/s: 420 g/L MCPA present as potassium salt, 26 g/L picloram present as potassium salt
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For the control of climbing buckwheat, common sowthistle, skeleton weed, capeweed, doublegee and other broadleaf weeds in winter cereals and linseed crops
Date of Registration: 23 May 2013
Label Approval No: 68707/58934
Product Name: Expra Multi-Fit Refill Contains Pyrethrins Fits Automatic Dispensers For: Robocan Raid (Will Not Fit ‘Advanced’ Model). Pestrol Insect Eliminator
Active Constituent/s: 4.4 g/kg d-allethrin, 3.5 g/kg tetramethrin, 1.1 g/kg pyrethrins, 45 g/kg piperonyl butoxide
Applicant Name: STM Group NZ Limited
Applicant ACN: N/A
Summary of Use: For protection from most flying and crawling insects
Date of Registration: 23 May 2013
Label Approval No: 68526/58524
Product Name: EcoGibb 400SG Plant Growth Regulator Soluble Granule
Active Constituent/s: 400 g/kg gibberellic acid
Applicant Name: Quinfert Pty Ltd
Applicant ACN: 128 460 800
Summary of Use: For foliar spray application to stimulate production of winter dormant grass -dominant pastures for high intensity grazing such as dairy pastures or sheep lambing paddocks
Date of Registration: 24 May 2013
Label Approval No: 68780/59063
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 8
Notice of Registrations – New Agricultural Chemical Products
Product Name: Sharp Shooter Weed Killer 360 Glyphosate Concentrate
Active Constituent/s: 360 g/L glyphosate present as the isopropylamine salt
Applicant Name: Ausgro Technologies Pty Ltd
Applicant ACN: 062 891 123
Summary of Use: For non-selective control of many annual and perennial weeds and grasses
Date of Registration: 24 May 2013
Label Approval No: 68378/58256
Product Name: Ratshot Rat and Mouse Killer Paste
Active Constituent/s: 0.05 g/kg difenacoum
Applicant Name: Freezone Public Health Pty Ltd
Applicant ACN: 132 080 098
Summary of Use: For the control of rats and mice in and around buildings
Date of Registration: 24 May 2013
Label Approval No: 68763/59031
Product Name: Ratshot Rodenticide Blocks
Active Constituent/s: 0.05 g/kg difenacoum
Applicant Name: Freezone Public Health Pty Ltd
Applicant ACN: 132 080 098
Summary of Use: For control of rats and mice in indoor and outdoor situations
Date of Registration: 24 May 2013
Label Approval No: 68762/59030
Product Name: Ratshot Rodenticide Placepacks
Active Constituent/s: 0.05 g/kg difenacoum
Applicant Name: Freezone Public Health Pty Ltd
Applicant ACN: 132 080 098
Summary of Use: For the control of rats and mice in and around buildings
Date of Registration: 24 May 2013
Label Approval No: 68761/59029
Product Name: Gardenline Weed Kill Concentrate
Active Constituent/s: 100 g/L glyphosate (present as the isopropylamine salt)
Applicant Name: Amgrow Pty Ltd
Applicant ACN: 100 684 786
Summary of Use: For the control of weeds and grasses in home garden situations
Date of Registration: 27 May 2013
Label Approval No: 68778/59061
Product Name: Ratshot Reusable Baited Rat Kill Station
Active Constituent/s: 0.05 g/kg difenacoum
Applicant Name: Freezone Public Health Pty Ltd
Applicant ACN: 132 080 098
Summary of Use: For the control of rats and mice in and around buildings
Date of Registration: 27 May 2013
Label Approval No: 68760/59028
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 9
Notice of Registrations – New Agricultural Chemical Products
Product Name: Mortein Home Expert Crawling Insect Bomb
Active Constituent/s: 10 g/kg permethrin, 0.77 g/kg fenoxycarb
Applicant Name: Reckitt Benckiser (Australia) Pty Limited
Applicant ACN: 003 274 655
Summary of Use: For household insect control.
Date of Registration: 27 May 2013
Label Approval No: 68765/59034
Product Name: AFA Top Oil Spray Adjuvant
Active Constituent/s: 700 g/L ethyl and methyl esters of vegetable oil
Applicant Name: Agricultural Formulators Australia Pty Ltd
Applicant ACN: 146 039 661
Summary of Use: For use with herbicides and other agricultural chemicals
Date of Registration: 27 May 2013
Label Approval No: 67844/56950
Product Name: Apparent Canola Oil Wetter 840
Active Constituent/s: 840 g/L canola oil
Applicant Name: Apparent Pty. Ltd.
Applicant ACN: 143 724 136
Summary of Use: To improve chemical uptake and rainfastness, improve drift control and droplet deposition and assist with odour reduction and evaporation
Date of Registration: 27 May 2013
Label Approval No: 68850/59212
2. VARIATIONS
Product Name: AW Genoa Herbicide
Applicant Name: Agri West Pty Limited
Applicant ACN: 108 899 181
Summary of Variation: To change the product name from ‘AW IMPALE HERBICIDE’ to ‘AW GENOA HERBICIDE’, update the Relevant Label Particulars and remove use in subterranean clover
Date of Variation: 16 May 2013
Label Approval No: 63425/58997
Product Name: Glister 450 Herbicide
Applicant Name: Sinon Australia Pty Limited
Applicant ACN: 102 741 024
Summary of Variation: To add additional uses and update the label details
Date of Variation: 16 May 2013
Label Approval No: 61639/58709
Product Name: Revus Fungicide
Applicant Name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of Variation: To extend Relevant Label Particulars claims to include control of downy mildew in oilseed poppies
Date of Variation: 16 May 2013
Label Approval No: 63052/56577
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 10
Notice of Registrations – New Agricultural Chemical Products
Product Name: Family Protection Aerogard Odourless Protection 4 Hours Protection Low Irritant* Great For Kids 12 Months + Insect Repellent Spray
Applicant Name: Reckitt Benckiser (Australia) Pty Limited
Applicant ACN: 003 274 655
Summary of Variation: To change product name from ‘FAMILY PROTECTION AEROGARD ODOURLESS LOW IRRITANT* GREAT FOR KIDS 12 MONTHS & OVER INSECT REPELLENT SPRAY ’ to ‘FAMILY PROTECTION AEROGARD ODOURLESS PROTECTION 4 HOURS PROTECTION LOW IRRITANT* GREAT FOR KIDS 12 MONTHS + INSECT REPELLENT SPRAY’
Date of Variation: 17 May 2013
Label Approval No: 61365/58726
Product Name: Family Protection Aerogard Odourless Protection 4 Hours Protection Low Irritant* Great For Kids 12 Months + Insect Repellent Roll On
Applicant Name: Reckitt Benckiser (Australia) Pty Limited
Applicant ACN: 003 274 655
Summary of Variation: To change product name from ‘FAMILY PROTECTION AEROGARD ODOURLESS LOW IRRITANT* GREAT FOR KIDS 12 MONTHS & OVER INSECT REPELLENT ROLL ON ’ to ‘FAMILY PROTECTION AEROGARD ODOURLESS PROTECTION 4 HOURS PROTECTION LOW IRRITANT* GREAT FOR KIDS 12 MONTHS + INSECT REPELLENT ROLL ON’
Date of Variation: 17 May 2013
Label Approval No: 61363/58718
Product Name: Opus 125 Fungicide
Applicant Name: BASF Australia Ltd.
Applicant ACN: 008 437 867
Summary of Variation: To include powdery mildew in wheat, net form of net blotch in barley, leaf scald in barley and powdery mildew in barley in use pattern
Date of Variation: 17 May 2013
Label Approval No: 57982/58817
Product Name: Woolworths Select Indoor Automatic Insect Control System
Applicant Name: Pascoe's Pty Ltd
Applicant ACN: 055 220 463
Summary of Variation: To vary the product name from ‘WOOLWORTHS SELECT 2 IN 1 INDOOR & OUTDOOR AUTOMATIC INSECT CONTROL SYSTEM’ to ‘WOOLWORTHS SELECT INDOOR AUTOMATIC INSECT CONTROL SYSTEM’ and update the label
Date of Variation: 22 May 2013
Label Approval No: 67945/58984
Product Name: Nufarm Associate Herbicide
Applicant Name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of Variation: To extend the use for the control of extra brush and broad-leaf weed species in forestry situations by hand and aerial/boom application
Date of Variation: 23 May 2013
Label Approval No: 46361/58247
Product Name: Success Neo Insecticide
Applicant Name: Dow AgroSciences Australia Limited
Applicant ACN: 003 771 659
Summary of Variation: To include aerial spraying on mangoes
Date of Variation: 23 May 2013
Label Approval No: 64109/56679
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 11
Notice of Registrations – New 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.
3. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Dental DLK 22 Canine
Active Constituent/s: N/A
Applicant Name: Royal Canin Australia Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: A complete therapeutic pet diet for dogs intended to treat and prevent a range of dental conditions in dogs
Date of Registration: 10 May 2013
Label Approval No: 67718/56708
Product Name: Dental Special DSD 25 Small Dog Under 10kg Canine-10kg
Active Constituent/s: N/A
Applicant Name: Royal Canin Australia Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: A complete therapeutic pet diet for dogs intended to treat and prevent a range of dental conditions in dogs less than 10kg
Date of Registration: 13 May 2013
Label Approval No: 67717/56704
Product Name: Hepatic HF 16 Canine
Active Constituent/s: N/A
Applicant Name: Royal Canin Australia Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: A complete therapeutic pet diet product intended to provide nutritional support for dogs with liver disease under veterinary supervision
Date of Registration: 14 May 2013
Label Approval No: 67992/57238
Product Name: Satiety Support SAT 30 Weight Management Canine
Active Constituent/s: N/A
Applicant Name: Royal Canin Australia Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: A complete pet diet product intended for controlled weight loss in dogs under veterinary supervision
Date of Registration: 14 May 2013
Label Approval No: 67904/57056
Product Name: Bob Martin since 1892 Cat & Kitten Dewormer Paste
Active Constituent/s: 264 mg/g niclosamide, 90 mg/g pyrantel embonate
Applicant Name: Bob Martin (Australia) Pty Ltd
Applicant ACN: 062 627 883
Summary of Use: For the treatment of roundworms, hookworms and tapeworms in cats and kittens
Date of Registration: 24 May 2013
Label Approval No: 65514/51088
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 12
Notice of Registrations – New Veterinary Chemical Products
4. VARIATIONS
Product Name: Hill's Prescription Diet W/D Feline Low Fat - Glucose Management - Gastrointestinal with Chicken (can)
Applicant Name: Hill's Pet Nutrition Pty Limited
Applicant ACN: 003 954 550
Summary of Variation: To change name from ‘HILL'S PRESCRIPTION DIET W/D WITH CHICKEN FELINE ’ to ‘HILL'S PRESCRIPTION DIET W/D FELINE LOW FAT - GLUCOSE MANAGEMENT - GASTROINTESTINAL WITH CHICKEN (CAN)’
Date of Variation: 10 May 2013
Label Approval No: 63623/53058
Product Name: Yours Droolly Flea & Tick Shampoo And Conditioner For Dogs & Puppies
Applicant Name: Aristopet Pty Ltd
Applicant ACN: 145 418 882
Summary of Variation: To change the product name from ‘BEAPHAR PERMETHRIN INSECTICIDAL SHAMPOO PLUS CONDITIONER FOR DOGS & PUPPIES’ to ‘YOURS DROOLLY FLEA & TICK SHAMPOO AND CONDITIONER FOR DOGS & PUPPIES’
Date of Variation: 21 May 2013
Label Approval No: 51361/54022
Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 13
Notice – New Agricultural Active Constituent – Ethanedinitrile
NOTICE – NEW AGRICULTURAL ACTIVE CONSTITUENT
Ethanedinitrile
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a
new active constituent, ethanedinitrile, for use as a fumigant.
PARTICULARS OF THE ACTIVE CONSTITUENT
IUPAC Name: Ethanedinitrile
CAS Name: Cyanogen
CAS Registry Number: 460-19-5
Minimum Purity: 860 g/kg
Molecular Formula: C2N2
Molecular Weight: 52.04
Structure:
Chemical Family: Nitrile
SUMMARY OF THE APVMA’S EVALUATION OF ETHANEDINITRILE ACTIVE CONSTITUENT
The Chemistry Section of the APVMA has evaluated the chemistry aspects of active constituent ethanedinitrile
(manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be
acceptable. Ethanedinitrile is a new active constituent.
On the basis of the data provided it is proposed that the following minimum compositional standard be established for
ethanedinitrile:
Constituent Specification Level
Ethanedinitrile
Hydrogen cyanide
Colourless gas
Colourless liquid
Minimum 860 g/kg
Maximum 50 g/kg
A maximum water content of 0.1 g/kg has been determined in the assessment of the active constituent. Water reacts
with the active constituent ethandinitrile to form hydrogen cyanide; the variation in the content of both ethandinitrile and
hydrogen cyanide is water dependant.
Other compounds of toxicological significance are not expected to occur in ethanedinitrile as a result of the raw materials
and the synthetic route used.
The Office of Chemical Safety (OCS) of the Department of Health and Ageing has considered the toxicological aspects
of ethanedinitrile, and advised that there are no objections on human health grounds to the approval of ethanedinitrile.
The OCS has not set an ADI or ARfD for ethandinitrile or cyanide, the main food residue and moiety of toxicological
concern, resulting from ethandinitrile residue ingestion, mainly because its use for grain treatment is not supported and
residues in soil are likely to be negligible at the time of crop planting. The Joint FAO/WHO Expert Committee on Food
Additives (JECFA) has recently established a provisional maximum tolerated daily intake (PMTDI) of 0.02 mg/kg bw/d
and ARfD of 0.09 mg/kg bw/d for cyanide (JECFA 2011), in a review of dietary exposure to ethandinitrile glycosides in
food products. These values have been adopted by FSANZ.
N C C N
Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 14
Notice – New Agricultural Active Constituent – Ethanedinitrile
Ethanedinitrile is listed (as ethanedinitrile) in Schedule 7 and in Appendix J (condition 1 – not to be available except to
authorised or licensed persons) of the SUSMP. This listing is consistent with its toxicological profile and the existing
Schedule 7 inclusion of cyanides and hydrocyanic acid.
The APVMA accepts the findings and recommendations of its advisors on these criteria.
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 ethanedinitrile 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.
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.
Written submissions on the APVMA’s proposal to grant approval for ethanedinitrile that relate to the grounds for
approval should be addressed in writing to:
Pesticides Chemistry Evaluation Manager
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4936
Fax: +61 2 6210 4840
Email: [email protected]
1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
http://www.comlaw.gov.au/ComLaw/Legislation/ActCompilation1.nsf/current/bytitle/A06DDA96E680781ECA2573120082EBE6?OpenDocument&mostrecent=1
Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 15
Notice – New Agricultural Chemical Products – Ethanedinitrile in the product Sterigas 1000 Fumigant
NOTICE – NEW AGRICULTURAL CHEMICAL PRODUCTS
Ethanedinitrile in the product Sterigas 1000 Fumigant
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from BOC Limited
for registration of a new product containing the Ethanedinitrile. The product is STERIGAS 1000 FUMIGANT. The product
is for the control of fungi and insects infesting timber.
PARTICULARS OF THE APPLICATION
Proposed Product Name(s): STERIGAS 1000 FUMIGANT
Applicant Company: BOC Limited
Name of Active Constituent: Ethanedinitrile
Signal Heading: Schedule 7
Summary of Proposed Use: For the control of fungi and insects infesting timber
Pack Sizes: 30 kg
SUMMARY OF THE APVMA’S EVALUATION OF STERIGAS 1000 FUMIGANT 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 STERIGAS 1000 FUMIGANT would not be an undue hazard to
the safety of people exposed to it during its handling and use when used in accordance with the proposed label
directions.
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 when used in accordance with the proposed label directions.
Based on worker exposure data, the toxicology data and other information on the product provided and considered
in the risk assessment, the First Aid Instructions, Warning Statement, Safety Directions, Precaution Statements and
Re-handling statement have been established to minimise worker exposure to the lowest practicable level.
The proposed use of STERIGAS 1000 FUMIGANT is limited to sealed fumigation enclosures where gas remaining
in the enclosure at the end of the fumigation period is passed through a liquid scrubbing system prior to ventilation.
The APVMA accepts the findings and recommendations of the OCS evaluation.
(ii) The APVMA is satisfied that the proposed use of STERIGAS 1000 FUMIGANT will not be an undue hazard to the
safety of people using anything containing its residues provided the product is used in accordance with the
proposed label directions.
(iii) The APVMA is satisfied that the proposed use of STERIGAS 1000 FUMIGANT containing the active constituent
Ethanedinitrile is not likely to be harmful to human beings if used according to the product label directions.
Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 16
Notice – New Agricultural Chemical Products – Ethanedinitrile in the product Sterigas 1000 Fumigant
First aid and Safety Directions recommended by the Office of Chemical Safety have been included on the label.
The APVMA accepts the findings and recommendations of its advisors on these criteria.
(iv) The APVMA is satisfied that the proposed use of STERIGAS 1000 FUMIGANT 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.
(v) The APVMA is satisfied that the proposed use of STERIGAS 1000 FUMIGANT would not adversely affect trade
between Australia and places outside Australia.
(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 contact officer listed 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 STERIGAS 1000 FUMIGANT 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)
1 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:
1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
http://www.apvma.gov.au/consultation/publichttp://www.comlaw.gov.au/ComLaw/Legislation/ActCompilation1.nsf/current/bytitle/A06DDA96E680781ECA2573120082EBE6?OpenDocument&mostrecent=1
Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 17
Notice – New Agricultural Chemical Products – Ethanedinitrile in the product Sterigas 1000 Fumigant
Contact Officer
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4700
Fax: +61 2 6210 4776
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 18
Notice – New Veterinary Chemical Products – Carbimazole in the products Vidalta 15 mg Tablets For Cats and Vidalta 10 mg Tablets For Cats
NOTICE – NEW VETERINARY CHEMICAL PRODUCTS
Carbimazole in the products Vidalta 15 mg Tablets For Cats and Vidalta 10 mg Tablets For Cats
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Intervet
Australia Pty Limited, for registration of a new product containing carbimazole. The products are VIDALTA 15 MG
TABLETS FOR CATS and VIDALTA 10 MG TABLETS FOR CATS. The products are to be used for the treatment of
hyperthyroidism and hyperthyroidism-associated clinical signs in cats.
PARTICULARS OF THE ACTIVE CONSTITUENT
Common Name: Carbimazole
IUPAC Name: Ethyl-3-methyl-2-thioxo-2,3-dihydro-1H-imidazole-1-carboxylate
CAS Name: 2,3-Dihydro-3-methyl-2-thioxo-1H-imidazole-1-carboxylic acid ethyl ester
CAS Registry Number: 22232-54-8
Manufacturer’s Codes: FP253
Minimum Purity: 98.0-102.0%
Molecular Formula: C7H10N2O2S
Molecular Weight: 186.2
Structure:
Chemical Family: Mercaptoimidazole
Mode of Action: Inhibition of thyroid peroxidase
SUMMARY OF THE APVMA’S EVALUATION OF CARBIMAZOLE
Carbimazole is a new active constituent and there is a compendial specification available in the European
Pharmacopoeia (0884).
The Pharmaceutical Chemistry Section of the APVMA has evaluated the chemistry and manufacturing aspects
carbimazole and is satisfied that all the data requirements (including the physico-chemical properties, spectral
identification, manufacturing and quality control aspects, impurity formation, active constituent specification, stability,
batch analysis data, analytical methods and packaging information) necessary for the approval of this new active
constituent have been met.
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 19
Notice – New Veterinary Chemical Products – Carbimazole in the products Vidalta 15 mg Tablets For Cats and Vidalta 10 mg Tablets For Cats
PARTICULARS OF THE APPLICATION
Proposed Product Name(s): VIDALTA 15 MG TABLETS FOR CATS
VIDALTA 10 MG TABLETS FOR CATS
Applicant Company: Intervet Australia Pty Limited
Name of Active Constituent: Carbimazole
Signal Heading: Prescription Animal Remedy - Schedule 4
Summary of Proposed Use: For the treatment of hyperthyroidism and hyperthyroidism-associated
clinical signs in cats.
Pack Sizes: 1 x 30 tablets; 1 x 100 tablets; 6 x 30 tablets; 6 x 100 tablets
Withholding Period: N/A
SUMMARY OF THE APVMA’S EVALUATION OF VIDALTA 15 MG TABLETS FOR CATS AND VIDALTA 10 MG
TABLETS FOR 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:
(i) The APVMA is satisfied that the proposed use of VIDALTA 15 MG TABLETS FOR CATS and VIDALTA 10 MG
TABLETS FOR CATS would not be an undue hazard to the safety of people exposed to them during their handling
and use.
The Office of Chemical Safety (OCS), formerly known as The Office of Chemical Safety and Environmental Health,
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 data submitted, it is estimated from the product ingredients that the products have low acute oral,
dermal and inhalation toxicity, and are not a skin or eye irritant or a skin sensitizer. Chronic toxicity studies in rats
and mice indicate that the thyroid gland is the primary target organ. No reliable evidence of a genotoxic potential for
methimazole has been seen in vitro or in vivo from the limited data. Developmental toxicity and developmental
neurotoxicity have been observed in animal studies following administration of methimazole over the gestation
and/or lactation period. Additionally, developmental toxicity was seen in a child from a hyperthyroid patient who
received methimazole during pregnancy. No standard reproductive toxicity or neurotoxicity studies in experimental
animals are available. Based on these findings the OCS has recommended first aid instructions, safety directions
and general precautions and warnings that are to be included on the product labeling. The APVMA has considered
and accepted the findings and recommendations of the OCS evaluation.
(ii) The APVMA is satisfied that the proposed use of VIDALTA 15 MG TABLETS FOR CATS and VIDALTA 10 MG
TABLETS FOR CATS will not be an undue hazard to the safety of people using anything containing their residues.
The product is for use on companion animals only. Carbimazole 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.
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 20
Notice – New Veterinary Chemical Products – Carbimazole in the products Vidalta 15 mg Tablets For Cats and Vidalta 10 mg Tablets For Cats
(iii) The APVMA is satisfied that the proposed use of VIDALTA 15 MG TABLETS FOR CATS and VIDALTA 10 MG
TABLETS FOR CATS containing the active constituent carbimazole is not likely to be harmful to human beings if
used according to the product label directions.
Carbimazole is already included in Schedule 4 of the Standard for the Uniform Scheduling of Medicines and
Poisons (SUSMP). The delegate to the Secretary of the Department of Health and Ageing noted that carbimazole’s
current scheduling as a prescription-only medicine remains appropriate, covering both human and animal clinical
uses. Therefore, the Secretary’s delegate recommended that carbimazole remain in Schedule 4 of the SUSMP with
no cut-off. The signal heading appropriate to Schedule 4 and the first aid instructions, safety directions and general
precautions and warnings recommended by the OCS will appear on the product label.
(iv) The APVMA is satisfied that the proposed use of VIDALTA 15 MG TABLETS FOR CATS and VIDALTA 10 MG
TABLETS FOR 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.
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 animals, plants, things or the environment. The APVMA has considered these
findings and accepts the recommendations of DSEWPaC.
The APVMA has assessed the safety of the proposed products to target animals based on data submitted to it by
the applicant. The potential developmental toxicity and neurotoxicity risk associated with the use of the proposed
product in pregnant animals will be mitigated by a label statement precluding use in pregnant or lactating queens.
The APVMA is satisfied that the proposed product would not have an unintended effect that is harmful to animals.
(v) The APVMA is satisfied that the proposed use of VIDALTA 15 MG TABLETS FOR CATS and VIDALTA 10 MG
TABLETS FOR CATS would not adversely affect trade between Australia and places outside Australia as the
product is for use in cats, which are not food-producing animals nor do they produce any major Australian export
commodities.
(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
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 VIDALTA 15 MG TABLETS FOR CATS and VIDALTA 10
MG TABLETS FOR 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.
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 21
Notice – New Veterinary Chemical Products – Carbimazole in the products Vidalta 15 mg Tablets For Cats and Vidalta 10 mg Tablets For Cats
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)
1 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 Contact Officer
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4700
Fax: +61 2 6210 4741
Email: [email protected]
1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
http://www.comlaw.gov.au/ComLaw/Legislation/ActCompilation1.nsf/current/bytitle/A06DDA96E680781ECA2573120082EBE6?OpenDocument&mostrecent=1
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 22
Other notices – Revocation of Suspension of Selected Products Containing 2,4-D ethyl ester and associated Label Approvals
OTHER NOTICES
Revocation of Suspension of Selected Products Containing 2,4-D ethyl ester and associated Label Approvals
On 29 April 2013 the APVMA revoked the suspension of Nufarm Estercide 800 Herbicide (31209) registered to Nufarm
Australia Limited, for the purpose of approving a new label as part of an application to vary the label of the product.
On 2 May 2013 the APVMA revoked the suspension of Crop Care Ester 800 Selective Herbicide (56764) registered to
Crop Care Australasia Pty Ltd for the purpose of approving a new label as part of an application to vary the label of the
product.
Although the suspension of these products has been revoked, the continued registration of the products and approval of
the labels are subject to the outcomes of the APVMA’s review of 2,4-D.
APVMA CONTACT
For any enquiries for or further information about this matter, please contact:
Chemical Review
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4768
Fax: +61 2 6210 4774
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 23
Other notices – Cancellation of Label Approval at the Request of the Registrant
Cancellation of Label Approval at the Request of the Registrant
At the request of the registrant, the APVMA has cancelled selected label approval(s) of the following products:
Product No. Product Name Registrant Labels Cancelled Date of Effect
31209 Nufarm Estercide 800 Herbicide Nufarm Australia Limited 31209/0902
31209/01
31209/0498
31209/0705
31209/0998
31209/1197
29 April 2013
56764 Crop Care Ester 800 Selective
Herbicide
Crop Care Australasia Pty Ltd 56764/0203
56764/0705
2 May 2013
The following instructions set out how a person can deal with the products bearing the cancelled labels.
As part of this consideration the APVMA has declared that sections s.45A(5) and s.55(3) of the Agvet Code do
not apply in relation to the supply and use of the product Nufarm Estercide 800 Herbicide (31209) bearing the
cancelled labels 31209/0902, 31209/01, 31209/0498, 31209/0705, 31209/0998 and 31209/1197.
The APVMA has also declared that sections s.45A(5) and s.55(3) of the Agvet Code do not apply in relation to the
supply and use of the product Crop Care Ester 800 Selective Herbicide (56764) bearing the cancelled labels
56764/0203 and 56764/0705.
In addition the APVMA determined that a period, until 31 August 2013 applies for the possession, supply and use
of these registered products bearing cancelled labels, in accordance with instructions issued by the APVMA, as
specified in this Notice.
INSTRUCTIONS FOR POSSESSING, HAVING CUSTODY OF, USING, OR DEALING WITH SUSPENDED
PRODUCTS, OR PRODUCTS CONTAINING THE SUSPENDED LABELS.
These instructions apply to the use of products Nufarm Estercide 800 Herbicide (31209) bearing the cancelled
labels 31209/0902, 31209/01, 31209/0498, 31209/0705, 31209/0998 and 31209/1197 and Crop Care Ester 800
Selective Herbicide (56764) bearing the cancelled labels 56764/0203 and 56764/0705.
Possession and custody
A person may possess, have custody of, use, or otherwise deal with the product containing a cancelled label only
in accordance with these instructions.
Supply
Product may only be supplied, if a copy of the instructions contained in this notice is securely affixed to the
container.
Use
These instructions apply to the use of products Nufarm Estercide 800 Herbicide (31209) bearing the cancelled
labels 31209/0902, 31209/01, 31209/0498, 31209/0705, 31209/0998 and 31209/1197 and Crop Care Ester 800
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 24
Other notices – Cancellation of Label Approval at the Request of the Registrant
Selective Herbicide (56764) bearing the cancelled labels 56764/0203 and 56764/0705 in all states and
territories.
READ THESE INSTRUCTIONS before using or otherwise handling the product.
When using or otherwise handling the product, follow these instructions.
Other than as specified below, the products must be used in accordance with the instructions on the label
attached to the container. Where the below instructions are inconsistent with the label instructions, the
instructions in this notice (below) must be followed.
In all states and territories the following are new DIRECTIONS FOR USE:
RESTRAINTS:
This is a PHENOXY HERBICIDE that can cause severe damage to native vegetation and susceptible crops such
as cotton, grapes, tomatoes, oilseed crops and ornamentals.
DO NOT apply this product between 1 September and 30 April, unless authorised by an APVMA permit.
Use of the product may only occur between 1 May and 31 August.
DO NOT apply this product by air.
DO NOT apply this product
in aquatic situations
to sugar cane
to rights of way
as a harvest aid/salvage spray.
DO NOT apply more than 800 g ae/ha (1L of this product per ha) (ae=acid equivalent).
DO NOT apply if crop or weeds are stressed due to dry or excessively moist conditions.
DO NOT use unless wind speed is more than 3 kilometres per hour and less than 15 kilometres per hour as
measured at the application site.
DO NOT apply with smaller than Coarse spray droplets according to the ASAE S572 definition for standard
nozzles.
DO NOT use if rain if likely within 6 hours.
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 25
Other notices – Cancellation of Label Approval at the Request of the Registrant
DIRECTIONS FOR USE - FIELD CROPS AND PASTURES
Situation
and Crop
Weeds State Rate Withholding
Period (days)
Critical Comments
Wheat, Barley Refer Weed Table
Vic only 180–700mL/ha 7
CROP STAGES: ALL CEREALS
Apply at tillered to boot stages.
(Vic only)
(DC 30-39) Apply when the first
node can be felt at the base of the
tiller and before swelling of the
head can be felt in a tiller. (NSW
only)
Apply from mid-tillering to before
boot stage. (Qld only)
Apply from completion of tillering
to early jointing stage. (SA only)
Apply from the 5 leaf stage up to
jointing stage
(Zadoks 15-33). Apply only at 6
leaf stage for cranbrook and jacup
wheats (Zadoks 16) to avoid
possible damage (WA only).
Qld,
NSW
only
350–700mL/ha
SA only 200–700mL/ha
WA only 700mL/ha
Triticale Qld,
NSW
only
350–700mL/ha
SA only 200–700mL/ha
Vic,
NSW
only
180–700mL/ha
Cereal Rye Qld,
NSW
only
350–700mL/ha
Vic only 180–700mL/ha
Pastures -
Direct Drilling
or Surface
Sowing
Charlock, Clover,
Medics,
Mustards,
Paterson’s
Curse, Saffron,
Slender,
Variegated and
Spear
Thistles, Turnip
Weed,
Wild Radish, Wild
Turnip,
Capeweed,
Wireweed,
Storksbill /
Erodium,
Flatweed,
Horehound
(seedlings),
Skeleton
Weed, Nodding or
Star
Thistles
Qld, WA,
Vic NSW
only
700mL–1L/ha
7 Apply to young, actively growing
weeds.
SOWING: Do not sow pasture
seeds for at least 21 days after
application. If soil moisture is dry,
delay sowing for at least 30 days.
All of the above
plus
grasses
As above plus
other herbicide
such as
glyphosate
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 26
Other notices – Cancellation of Label Approval at the Request of the Registrant
Situation
and Crop
Weeds State Rate Withholding
Period (days)
Critical Comments
Improved
Pasture
containing
Clover
Refer Weed Table Qld,
NSW,
SA only
350–700mL/ha 7 Clover must be well covered by
the grass or extensive damage
may result.
Pastures - non
legumes,
Refer Weed Table
NOTE: the
following weeds
may not be
controlled at these
rates
Apple of Sodom
Black Knapweed
Buffalo Burr
Colocynth
Galvanised Burr
Hard Head /
Russian Knapweed
Nut Grass
St Johns Wort
Sand Mustard
/Sand Rocket
Silverleaf
Nightshade
Thistle
- Golden
- Nodding
- Soldier
- Stemless
Wild Sage
Wild Teasel
Qld, Vic,
NSW,
SA, WA
only
700mL–1L/ha Control of most perennial weeds,
but due to the rooting habits of
most species control may take a
number of years. Damage may
result to legumes in pasture.
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THESE INSTRUCTIONS
UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.
WITHHOLDING PERIOD: PASTURE, CEREAL CROPS - DO NOT GRAZE OR CUT FOR STOCK FOOD FOR 7
DAYS AFTER APPLICATION.
ADDITIONAL INSTRUCTIONS
Buffer zones
Use only Coarse to Very Coarse spray quality according to ASAE S572 definition for standard nozzles, and a
buffer zone of 100 m between field edges and downwind water bodies, native vegetation and sensitive crops.
Permissible Dates of Application of 2,4-D High Volatile Esters
Application of 2,4-D ethyl ester, butyl ester or isobutyl ester must only take place during a spray window between
1 May and 31 August.
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 27
Other notices – Cancellation of Label Approval at the Request of the Registrant
Victoria, Western Australia, Tasmania and Queensland currently have mechanisms whereby the use of specific
chemicals (including 2,4-D) is restricted to geographical areas and/or time zones due to the higher risk for
adverse off-target crop or environmental effects. These state restrictions on 2,4-D use may place additional
requirements on users within this spray window between 1 May and 31 August, for example, length of the spray
window and spray equipment. Users must consult their local authority or department of agriculture to ensure they
meet state requirements.
Application of 2,4-D only within this spray window will minimise the risk of unintended harmful effects to native
vegetation and susceptible crops. Avoid spraying upwind of nearby susceptible crops.
RECORD KEEPING REQUIREMENTS
Within 24 hours of completing a 2,4-D ethyl, butyl or isobutyl ester application all users must make and keep a
record of each application. The details required in a 2,4-D ester spray record must contain at least the information
set out below. It is the recommended and considered good practice, that the grower collects from any person
acting on his or her behalf a copy of the 2,4-D ester spray record. (For convenience, a 2,4-D record-keeping form
can be obtained from the Australian Pesticides and Veterinary Medicines Authority website.)
General:
Name and address of farm owner
(or grower if grower is not owner)
Name and address of person who
applied 2,4-D
Date of application
Whether neighbours have been
notified Y/N (this is not a
mandatory requirement)
Map of farm with treated field or
paddock outlined on map and field
number or name indicated
Area of field or paddock sprayed
with 2,4-D
Crop/situation and Pest Details:
Name of crop/situation Major types of pests present Pest stage of growth
Weather Conditions at Application Site:
Conditions at time of application
(showers, overcast, partly cloudy,
clear sky, inversion conditions)
Temperature and humidity at time
of application
Wind speed and direction at
beginning of application
Wind consistency (gusty/steady
breeze, direction steady/variable)
Whether wind direction changed
during application and to where
Whether wind speed changed
during application and to what
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 28
Other notices – Cancellation of Label Approval at the Request of the Registrant
Application Details:
Sprayer pressure used Equipment and type of nozzles
used
Speed of ground application
equipment
Product name or unique APVMA
approval number
Amount of 2,4-D product applied
per hectare
Total volume of spray mixture
applied per hectare
Any additives used in mixture and
rate of use
Time at beginning of application Time at end of application
A statement saying the information on this record is accurate and correct, followed by the signature of the user.
Warning
The labels of these products are not approved. A person must not possess with the intent to supply, or deal with
any of these products bearing the cancelled labels except in accordance with the instructions contained in this
notice. A failure to comply with them will result in an offence against the Agvet Codes and the APVMA will take
appropriate compliance action.
APVMA Contact
For any enquiries or further information about this matter, please contact:
Chemical Review
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
SYMONSTON ACT 2609
Phone: +61 2 6210 4749
Fax: +61 2 6210 4774
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 29
Other notices – Cancellation of Product Registration
Cancellation of Product Registration
In accordance with s44(1) of the Agvet Codes ‘if the APVMA cancels the only approval or all approvals of an active
constituent for an existing chemical product, it must also cancel any registration of that product’. The approval of the only
disulfoton active constituent was cancelled at the request of the approval holder in 2010.
The APVMA has now cancelled the registration of the only remaining disulfoton product and associated label approval.
Product No. Product Name Registrant Label no. Date of Effect
48758 David Grays Disulfoton 50
Granular Insecticide
David Gray & Co Pty Limited 48758/01 27 May 2013
The following instructions set out how a person can deal with the cancelled product.
SUPPLY
A person may supply or cause to be supplied product manufactured prior to 27 May 2013 at wholesale and retail level,
until 27 May 2015.
After 27 May 2015 it will be an offence against the Agvet Codes to have possession or custody of the product with the
intention to supply the product.
USE
A person may continue to use the product according to its label instructions until 27 May 2015.
Any person who possesses, has custody of, uses, or otherwise deals with the listed product 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 product after the registration has been cancelled until 27 May 2015.
The supply and use of the product 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 product 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]
mailto:[email protected]
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 30
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. 10
For use in agricultural and/or veterinary chemical products:
Common Name Approval Holder Manufacturer and Site of Manufacture Approval No.
Clopyralid YONGNONG
BIOSCIENCES CO., LTD
YONGNONG BIOSCIENCES CO., LTD
WEIQI LU DONG,
HANGZHOU GULF FINE CHEMICAL ZONE
SHANGYU CITY, ZHEJIANG PROVINCE, 312369
CHINA
67719
Clomazone FMC AUSTRALASIA
PTY LTD
JIANGSU BAOZONG & BAODA PHARMACHEM CO.
LTD (JB)
NO. 10 YUEJIANG ROAD,
RUGAO PORT FINE CHEMICAL INDUSTRIAL PARK,
JIANGSU PROVINCE
P.R. CHINA
68335
Glyphosate FORWARD AUSTRALIA
PTY LTD
JIANGYIN NO. 2 PESTICIDES CO., LTD
1 QINGTONG ROAD
QINGYANG TOWN, JIANGYIN
JIANGSU 214401
P.R. CHINA
67397
Thiamethoxam AIMCO KR AUSTRALIA
PTY LTD
AIMCO PESTICIDES LIMITED
B 1/1 MIDC INDUSTRIAL AREA,
LOTE PARSHURAM, PB NO. 9, VILLAGE AWASHI
DISTRICT RATANGIRI 415 707 MAHARASHTRA
INDIA
68420
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
Email: [email protected]
http://www.apvma.gov.au/
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 31
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. 10
Application No. Name
55267 EUROCHEM METRO 250 WP INSECTICIDE
56336 QUINTOZENE
57427 MELOXICAM INJECTION
57789 BUG-AWAY
58064 NOT AVAILABLE
58065 NOT AVAILABLE
58066 NOT AVAILABLE
58415 ROUNDUP READY HERBICIDE WITH PLANTSHIELD BY MONSANTO
58438 RICHTAFORT PHOSPHORUS 125 + VITAMIN B12 INJECTION FOR HORSES, CATTLE & DOGS
58455 SUREFIRE PICLORAM & TRICLOPYR HERBICIDE
58486 LUNA SENSATION FUNGICIDE
58676 FMC SULFOSULFURON 750 WG HERBICIDE
58693 ELEGANT EC HERBICIDE
58840 PESTXPERT DIY PEST CONTROL LIKE THE PROFESSIONALS PRO-GRANULES MULTI-INSECT
CONTACT AND RESIDUAL BARRIER GRANULES
58926 NOT AVAILABLE
58950 NOT AVAILABLE
58952 NOT AVAILABLE
59144 CONCENTRATE TOUGH ROUNDUP WEEDKILLER
59195 FARMALINX SOLDIER HERBICIDE
59200 INSECTIGAS-D DDVP INSECTICIDE
59203 SUCCESS NEO INSECTICIDE
59209 VETSENSE FLYGON INSECTICIDAL AND REPELLENT SPRAY
http://www.apvma.gov.au/
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 32
Other notices – Application Summaries
Application No. Name
59211 VALUE PLUS FLY SPRAY
59263 ECHEM IMIDACLOPRID 200 INSECTICIDE
59305 NOT AVAILABLE
59307 TITAN GLUFOSINATE 200 HERBICIDE
59332 TRILOGY 600 HERBICIDE
59362 SABAKEM CAPTAN 800WDG FUNGICIDE
59380 RICO GLYPHOSATE 450
59393 KILLMASTER ZERO PEST STRIP
59420 NOT AVAILABLE
59452 NOT AVAILABLE
45878 PARA-AMINOPROPIOPHENONE
57227 NOT AVAILABLE
57229 NOT AVAILABLE
57230 NOT AVAILABLE
57231 NOT AVAILABLE
58202 VOODOO GUARD SOIL INSECTICIDE
58219 NOVAGUARD AMMONIUM SULPHATE HERBICIDE ADJUVANT
58527 ANIMAL SCIENCE INSECTICIDAL FLEA POWDER FOR DOGS, CATS, PUPPIES & KITTENS
58603 ELANCO AH0493 EXTINOSAD POUR-ON FOR SHEEP
58835 VITALYSE SHOCK N SWIM
58839 VITALYSE STABILISED CHLORINE RAPID RELEASE GRANULAR
58953 FAST ACTION ROUNDUP READY TO USE WEEDKILLER
59026 Y-TEX AGRESSOR CATTLE EAR TAGS
59054 DEFENDER ROSEPRIDE FUNGICIDE, INSECTICIDE & MITICIDE
59186 NOT AVAILABLE
59194 COOPERS BOVILIS ROTAVEC CORONA CALF SCOURS VACCINE
59265 FYFANON 440 EW INSECTICIDE
59281 AZOXYSTROBIN
59282 NOT AVAILABLE
59320 GARRISON PRUNING WOUND DRESSING FUNGICIDE
59330 GLYPHOSATE
59374 NUFARM RIFLE 440 HERBICIDE
59375 AMGROW PATROL PROFESSIONAL TERMITICIDE AND INSECTICIDE
Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 33
Other notices – Application Summaries
Application No. Name
59411 CASPER TURF HERBICIDE
59431 NUTRIAN WETTER 1000 ADJUVANT
59456 DEFENDER SNAIL & SLUG PELLETS
59466 TALON RAT & MOUSE KILLER EZY THROW
59485 GESAPAX COMBI 800 WG HERBICIDE GRANULES
59495 DUAL GOLD HERBICIDE
59524 GATEWAY 500 SELECTIVE HERBICIDE
59525 MACPHERSONS CHLORTHAL DIMETHYL 750WG PRE-EMERGENCE HERBICIDE
59543 PUTRA-AMINE 625 SELECTIVE HERBICIDE
59548 QUASH 250 HERBICIDE
59283 OAKWOOD SINCE 1990 PREMISES FLEA SPRAY
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: +61 2 6210 4701
Fax: +61 2 6210 4721
Email: [email protected]