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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

APVMA Gazette No. 11, 4 June 2013...2013/06/04  · Commonwealth of Australia Gazette No. APVMA 11, Tuesday, 4 June 2013 Agricultural and Veterinary Chemicals Code Act 1994 5 Notice

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  • 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

    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 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.

    DISTRIBUTION AND SUBSCRIPTION

    The APVMA Gazette is published in electronic format only and is available from the APVMA website,

    www.apvma.gov.au/publications/gazette/.

    If you would like to receive email notification when a new edition is published, please subscribe on the APVMA website.

    APVMA CONTACTS

    For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4870

    For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.

    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]