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No. APVMA 3, Tuesday, 10 February 2015
Published by The Australian Pesticides and 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 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 2
Commonwealth of Australia 2015
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 and Communications
The Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Email: communications@apvma.gov.au
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 grant ed by the APVMA, notices as required
by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material
issued by the APVMA.
Pursuant to section 8J(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications
made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activ ity 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.
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Erratum Notice ................................................................................................................................................................ 3 Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and approved labels ...................................................................................................... 11 Approved Active Constituents ....................................................................................................................................... 15 Amendments to the APVMA MRL Standard .................................................................................................................. 16 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code ............................................ 17 Cancellation of Approval at the Request of the Holder .................................................................................................. 22 Cancellation of Active Constituent Approval at the Request of the Holder .................................................................... 24 Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene ................................................................................................................................. 25 Licensing of Veterinary Chemical Manufacturers .......................................................................................................... 28
Erratum Notice
The Australian Pesticides and Veterinary Medicines Authority advises that an error was published in the Commonwealth
of Australia Gazette for Agricultural and Veterinary Chemicals, No. APVMA No. APVMA 1, Tuesday, 13 January 2015
In the Notice, Pyro Shield Natural Pyrethrum Metered Insecticide in the product name Pyrethrum was incorrectly spelt.
The correct entry for the Notice of Registration for Pyro Shield Natural Pyethrum Metered Insecticide appears on page 4 of this Gazette.
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 4
Agricultural Chemical Products and Approved Labels
Agricultural Chemical Products and Approved Labels
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals
Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of
the registration in respect of the following products and has approved the label or varied the relevant particulars or
conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.: 62502
Product name: Pyro Shield Natural Pyrethrum Metered Insecticide
Active constituent/s: 14 g/kg pyrethrum, 60 g/kg piperonyl butoxide
Applicant name: JHP Agencies Ltd
Applicant ACN: N/A
Summary of use For control of flies, mosquitoes, moths, ants, fleas and cockroaches
Date of registration/approval: 19 December 2014
Product registration no.: 70097
Label approval no.: 70097/62502
Application no.: 60734
Product name: Titan S-Metolachlor 960 Herbicide
Active constituent/s: 960 g/L s-metolachlor
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of use For control of a range of annual grasses and broadleaf weeds in a range of crops
Date of registration/approval: 21 January 2015
Product registration no.: 69410
Label approval no.: 69410/60734
Application no.: 60680
Product name: Imtrade Triallate 750 EC Herbicide
Active constituent/s: 750 g/L triallate
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of use For the control of wild oats in wheat, triticale, chickpeas, barley, peas, linseed, lupins, canola (rapeseed), faba beans and safflower
Date of registration/approval: 22 January 2015
Product registration no.: 69401
Label approval no.: 69401/60680
Application no.: 63486
Product name: SLTEC Fertilizers Ammonium Sulphate Herbicide Adjuvant
Active constituent/s: 980 g/kg ammonium sulfate
Applicant name: Sustainable Liquid Technology Pty Ltd
Applicant ACN: 113 670 269 Summary of use For use with glyphosate-based herbicides to minimise antagonism when tank mixing with
flowable herbicides and to improve performance under adverse environmental conditions
Date of registration/approval: 23 January 2015
Product registration no.: 70461
Label approval no.: 70461/63486
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 5
Agricultural Chemical Products and Approved Labels
Application no.: 100648
Product name: Term Block Termite Barrier
Active constituent/s: 4 g/kg deltamethrin (equivalent to 2 g/m2 deltamethrin)
Applicant name: Bayer Cropscience Pty Ltd
Applicant ACN: 000 226 022
Summary of use For the protection of buildings and structures against subterranean termites in accordance with AS3660—Termite Management
Date of registration/approval: 27 January 2015
Product registration no.: 80341
Label approval no.: 80341/100648
Application no.: 100649
Product name: GeoTerm Termite Barrier
Active constituent/s: 4 g/kg deltamethrin (equivalent to 2 g/m2 deltamethrin)
Applicant name: Bayer Cropscience Pty Ltd
Applicant ACN: 000 226 022
Summary of use For the protection of buildings and structures against subterranean termites in accordance with AS3660—Termite Management
Date of registration/approval: 27 January 2015
Product registration no.: 80342
Label approval no.: 80342/100649
Application no.: 62158
Product name: Pyresta Xtreme LV Herbicide
Active constituent/s: 2.1 g/L pyraflufen-ethyl, 600 g/L 2,4-d (present as the 2–ethylhexyl ester)
Applicant name: Sipcam Pacific Australia Pty Ltd
Applicant ACN: 073 176 888
Summary of use For improvement in the brownout of a range of broadleaf and grass weeds and improved control of marshmallow, long storksbill (erodium) and wild radish, when used in tank mixtures with glyphosate based herbicides
Date of registration/approval: 28 January 2015
Product registration no.: 69952
Label approval no.: 69952/62158
Application no.: 60132
Product name: Rotam Toledo 430SC Fungicide
Active constituent/s: 430 g/L tebuconazole
Applicant name: Rotam Agrochemical Co., Ltd
Applicant ACN: N/A
Summary of use For control of various diseases of bananas, peanuts, grapes, cereal crops, vegetables and other crops
Date of registration/approval: 29 January 2015
Product registration no.: 69174
Label approval no.: 69174/60132
Application no.: 58257
Product name: Bioquell HPV-AQ Disinfectant
Active constituent/s: 350 g/L hydrogen peroxide
Applicant name: Bioquell UK
Applicant ACN: N/A
Summary of use For sporicidal disinfectant for use in bio-decontamination of animal enclosures
Date of registration/approval: 30 January 2015
Product registration no.: 68380
Label approval no.: 68380/58257
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 6
Agricultural Chemical Products and Approved Labels
Application no.: 57849
Product name: Campbell Tru-Blue Spray Indicator
Active constituent/s: 105 g/L acid blue 9 disodium salt
Applicant name: Colin Campbell (Chemicals) Pty Ltd
Applicant ACN: 000 045 590
Summary of use For use as a marker dye in water based pesticide applications in agriculture and turf
Date of registration/approval: 2 February 2015
Product registration no.: 68258
Label approval no.: 68258/57849
Application no.: 60630
Product name: Nufarm Tally 800WG Aphicide
Active constituent/s: 800 g/kg pirimicarb (an anticholinesterase compound)
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of use For the control of certain aphids on crops and pastures
Date of registration/approval: 2 February 2015
Product registration no.: 69374
Label approval no.: 69374/60630
Application no.: 62706
Product name: Spalding Glufosinate 200 Herbicide
Active constituent/s: 200 g/L glufosinate—ammonium
Applicant name: Spalding Holdings Pty. Ltd
Applicant ACN: 010 155 852
Summary of use For the non-residual control of broadleaf and grass weeds in various situations
Date of registration/approval: 2 February 2015
Product registration no.: 70193
Label approval no.: 70193/62706
Application no.: 100443
Product name: Great Aussie Ammonium Sulfate Spray Grade Herbicide Adjuvant
Active constituent/s: 980 g/kg ammonium sulfate
Applicant name: Rivergold Holdings Pty Ltd T/A Great Aussie Stock Aids
Applicant ACN: 074 041 428
Summary of use For the use with glyphosate based herbicides to minimise antagonism when tank mixing with flowable herbicides and to improve performance under adverse environmental conditions
Date of registration/approval: 2 February 2015
Product registration no.: 80228
Label approval no.: 80228/100443
Application no.: 100024
Product name: Sabakem Quizalofop 200EC Selective Herbicide
Active constituent/s: 200 g/L quizalofop-p-ethyl
Applicant name: Sabakem Pty Ltd
Applicant ACN: 151 682 138
Summary of use: For the control of certain grass weeds in broadleaf crops
Date of registration/approval: 3 February 2015
Product registration no.: 80006
Label approval no.: 80006/100024
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 7
Agricultural Chemical Products and Approved Labels
Application no.: 62752
Product name: Conquest Ranga 240 SL Herbicide
Active constituent/s: 240 g/L imazapic present as the ammonium salt
Applicant name: Conquest Crop Protection Pty Ltd
Applicant ACN: 098 814 932
Summary of use For the pre-emergence control of certain annual grass and broadleaf weeds in fallow situation and sugarcane
Date of registration/approval: 4 February 2015
Product registration no.: 70218
Label approval no.: 70218/62752
Application no.: 100676
Product name: Talon Cockroach Killer Gel
Active constituent/s: 6 g/kg indoxacarb
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of use For the control of cockroaches in domestic situations
Date of registration/approval: 4 February 2015
Product registration no.: 80356
Label approval no.: 80356/100676
2. VARIATIONS OF REGISTRATION
Application no: 101414
Product name: Protect-Us Array Insecticide
Active constituent/s: 10 g/L deltamethrin
Applicant name: Ensystex Australasia Pty Ltd
Applicant ACN: 102 221 965
Summary of variation: To change the product name from ‘PROTECT–US PROFESSIONAL WATER-BASED INSECTICIDE’ to ‘PROTECT–US ARRAY INSECTICIDE’
Date of variation: 15 January 2015
Product registration no.: 67037
Label approval no.: 67037/101414
Application no: 101413
Product name: Aristopet Animal Health Stop Garden Crystals–Dog & Cat Repellent
Active constituent/s: 25 g/kg methyl nonyl ketone
Applicant name: Aristopet Pty Ltd
Applicant ACN: 145 418 882
Summary of variation: To change the product name from ‘STOP GARDEN CRYSTALS–DOG AND CAT REPELLENT’ to ‘ARISTOPET ANIMAL HEALTH STOP GARDEN CRYSTALS–DOG & CAT REPELLENT’
Date of variation: 15 January 2015
Product registration no.: 45194
Label approval no.: 45194/101413
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 8
Agricultural Chemical Products and Approved Labels
Application no.: 101440
Product name: Protect-Us Invader Ant Bait
Active constituent/s: 7.3 g/kg hydramethylnon
Applicant name: Ensystex Australasia Pty Ltd
Applicant ACN: 102 221 965
Summary of variation: To change the product name from ‘PROTECT-US PROFESSIONAL GRANULAR ANT BAIT’
to ‘PROTECT-US INVADER ANT BAIT’
Date of variation: 19 January 2015
Product registration no.: 68012
Label approval no.: 68012/101440
Application no.: 101439
Product name: Protect-Us Multipest Termiticide & Insecticide
Active constituent/s: 100 g/L bifenthrin
Applicant name: Ensystex Australasia Pty Ltd
Applicant ACN: 102 221 965
Summary of variation: To change product name from ‘PROTECT-US PROFESSIONAL WATER-BASED TERMITICIDE & INSECTICIDE’ to ‘PROTECT-US MULTIPEST TERMITICIDE & INSECTICIDE’
Date of variation: 19 January 2015
Product registration no.: 67069
Label approval no.: 67069/101439
Application no.: 101438
Product name: 67035
Active constituent/s: 2 g/kg bifenthrin
Applicant name: Ensystex Australasia Pty Ltd
Applicant ACN: 102 221 965
Summary of variation: To change product name from ‘PROTECT-US PROFESSIONAL GRANULAR INSECTICIDE’
to ‘PROTECT-US TURFAID INSECTICIDE GRANULES’
Date of variation: 19 January 2015
Product registration no.: 67035
Label approval no.: 67035/101438
Application no.: 101436
Product name: 67220
Active constituent/s: 0.05 g/kg brodifacoum
Applicant name: ZAPI S.P.A
Applicant ACN: N/A
Summary of variation: To change the product name from ‘PROTECT-US PROFESSIONAL BLOCK RODENTICIDE’
to ‘PROTECT-US STEALTH BLOCK RAT & MOUSE BAIT’
Date of variation: 19 January 2015
Product registration no.: 67220
Label approval no.: 67220/101436
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 9
Agricultural Chemical Products and Approved Labels
Application no.: 101390
Product name: Aerogard Heavy Duty 40% Deet Aerogard's Highest Strength Repellent Long Lasting Protection Personal Insect Repellent
Active constituent/s: 400 g/kg diethyltoluamide
Applicant name: Reckitt Benckiser (Australia) Pty Limited
Applicant ACN: 003 274 655
Summary of variation: To change the product name from ‘AEROGARD EXTREME ACTIVITIES 40% DEET AEROGARD'S HIGHEST STRENGTH REPELLENT PERSONAL INSECT REPELLENT’ to ‘AEROGARD HEAVY DUTY 40% DEET AEROGARD'S HIGHEST STRENGTH REPELLENT LONG LASTING PROTECTION PERSONAL INSECT REPELLENT’
Date of variation: 22 January 2015
Product registration no.: 69786
Label approval no.: 69786/101390
Application no: 100725
Product name: Mortein Kill & Protect Ant Sand Insecticide
Active constituent/s: 2 g/kg bifenthrin
Applicant name: Reckitt Benckiser (Australia) Pty Limited
Applicant ACN: 003 274 655
Summary of variation: To change the product name from ‘MORTEIN PROGARD PROTECTION
ANT SAND INSECTICIDE KILLS ANTS OUTSIDE EVEN AFTER RAIN’ to
‘MORTEIN KILL & PROTECT ANT SAND INSECTICIDE’
Date of variation: 29 January 2015
Product registration no.: 60920
Label approval no.: 60920/100725
Application no: 100749
Product name: Mortein Kill & Protect Barrier Outdoor Surface 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 variation: To change the product name from ‘MORTEIN PROGARD PROTECTION OUTDOOR
SURFACE SPRAY BARRIER SPRAY’ to ‘MORTEIN KILL & PROTECT
BARRIER OUTDOOR SURFACE SPRAY’
Date of variation: 30 January 2015
Product registration no.: 62677
Label approval no.: 62677/100749
Application no.: 100374
Product name: Aqua K-Othrine Insecticide Space-Spray Concentrate
Active constituent/s: 20 g/L deltamethrin
Applicant name: Bayer Cropscience Pty Ltd
Applicant ACN: 000 226 022
Summary of variation: To include new pests (cockroach, spiders and stored grain pests) and to amend the rate for indoor use and add a 1 L–10 L pack size range
Date of variation: 30 January 2015
Product registration no.: 63246
Label approval no.: 63246/100374
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 10
Agricultural Chemical Products and Approved Labels
Application no.: 100218
Product name: Milbeknock Miticide
Active constituent/s: 9.3 g/L milbemectin
Applicant name: Sipcam Pacific Australia Pty Ltd
Applicant ACN: 073 176 888
Summary of variation: To extend use to include control of two spotted mite in ornamentals
Date of variation: 28 January 2015
Product registration no.: 61269
Label approval no.: 61269/100218
Application no.: 61214
Product name: DuPont Talendo Fungicide
Active constituent/s: 200 g/L proquinazid
Applicant name: Du Pont (Australia) Pty Ltd
Applicant ACN: 000 716 469
Summary of variation: To include control of powdery mildew in field grown tomatoes and capsicums
Date of variation: 28 January 2015
Product registration no.: 64165
Label approval no.: 64165/61214
Application no: 62330
Product name: EverGol Prime Seed Treatment and In-Furrow Fungicide
Active constituent/s: 240 g/L penflufen
Applicant name: Bayer Cropscience Pty Ltd
Applicant ACN: 000 226 022
Summary of variation: To extend the label claims to include oats and in-furrow application and to change the product name from ‘EVERGOL PRIME SEED TREATMENT’ to ‘EVERGOL PRIME SEED TREATMENT AND IN-FURROW FUNGICIDE’
Date of variation: 2 February 2015
Product registration no.: 64744
Label approval no.: 64744/62330
Application no.: 100261
Product name: Conan 720 Fungicide
Active constituent/s: 720 g/L chlorothalonil
Applicant name: UPL Australia Limited
Applicant ACN: 066 391 384
Summary of variation: To include uses in turf
Date of variation: 2 February 2015
Product registration no.: 68458
Label approval no.: 68458/100261
3. VARIATION OF LABEL APPROVAL
Application no.: 62629
Product name: AC Big Dog 540 Herbicide
Active constituent/s: 540 g/L glyphosate (present as the isopropylamine salt)
Applicant name: Polygon (NZ) Limited
Applicant ACN: N/A
Summary of variation: To vary the instructions relating to the cultivation/planting interval
Date of variation: 21 January 2015
Label approval no.: 66406/62629
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 11
Veterinary Chemical Products and approved labels
Veterinary Chemical Products and approved labels
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals
Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of
the registration in respect of the following products and has approved the label or varied the relevant particulars or
conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS
Application no.: 59262
Product name: Bravecto 1400 mg Fluralaner Chewable Tablets For Very Large Dogs
Active constituent/s: 136.4 g/kg fluralaner
Applicant name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of use For the treatment and prevention of ticks and fleas on very large dogs
Date of Registration/approval: 23 January 2015
Product registration no.: 68873
Label approval no.: 68873/59262
Application no.: 59261
Product name: Bravecto 250 mg Fluralaner Chewable Tablets For Small Dogs
Active constituent/s: 136.4 g/kg fluralaner
Applicant name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of use For the treatment and prevention of ticks and fleas on small dogs
Date of Registration/approval: 23 January 2015
Product registration no.: 68872
Label approval no.: 68872/59261
Application no.: 59260
Product name: Bravecto 500 mg Fluralaner Chewable Tablets For Medium Dogs
Active constituent/s: 136.4 g/kg fluralaner
Applicant name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of use For the treatment and prevention of ticks and fleas on medium dogs
Date of Registration/approval: 23 January 2015
Product registration no.: 68871
Label approval no.: 68871/59260
Application no.: 59258
Product name: Bravecto 1000 mg Fluralaner Chewable Tablets For Large Dogs
Active constituent/s: 136.4 g/kg fluralaner
Applicant name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of use For the treatment and prevention of ticks and fleas on large dogs
Date of Registration/approval: 23 January 2015
Product registration no.: 68870
Label approval no.: 68870/59258
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 12
Veterinary Chemical Products and approved labels
Application no.: 59257
Product name: Bravecto 112.5 mg Fluralaner Chewable Tablets For Very Small Dogs
Active constituent/s: 136.4 g/kg fluralaner
Applicant name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of use For the treatment and prevention of ticks and fleas on very small dogs
Date of Registration/approval: 23 January 2015
Product registration no.: 68867
Label approval no.: 68867/59257
Application no.: 38185
Product name: Veraflox 120 mg Tablets For Dogs Antimicrobial
Active constituent/s: each tablet contains 120 mg pradofloxacin
Applicant name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of use For the treatment of bacterial infections of the skin, soft tissues, urinary tract, gingiva and periodontal tissues in dogs
Date of Registration/approval: 3 February 2015
Product registration no.: 60431
Label approval no.: 60431/38185
Application no.: 38184
Product name: Veraflox 15 mg Tablets For Dogs And Cats Antimicrobial
Active constituent/s: each tablet contains 15 mg pradofloxacin
Applicant name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of use For the treatment of bacterial infections of the skin, soft tissues, urinary tract, gingiva and periodontal tissues in dogs; For the treatment of bacterial infections of the respiratory tract and soft tissues in cats
Date of Registration/approval: 3 February 2015
Product registration no.: 60430
Label approval no.: 60430/38184
Application no.: 38183
Product name: Veraflox 60 mg Tablets For Dogs Antimicrobial
Active constituent/s: each tablet contains 60 mg pradofloxacin
Applicant name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of use For the treatment of bacterial infections of the skin, soft tissues, urinary tract, gingiva and periodontal tissues in dogs
Date of Registration/approval: 3 February 2015
Product registration no.: 60429
Label approval no.: 60429/38183
Application no.: 38182
Product name: Veraflox 25 mg/mL Oral Suspension For Cats Antimicrobial
Active constituent/s: 25 mg/mL pradofloxacin
Applicant name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of use For the treatment of bacterial infections of the respiratory tract and soft tissues in cats
Date of Registration/approval: 3 February 2015
Product registration no.: 60428
Label approval no.: 60428/38182
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 13
Veterinary Chemical Products and approved labels
2. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.: 62853
Product name: Hypoallergenic HME 23 Moderate Calorie Canine
Active constituent/s: N/A
Applicant name: Royal Canin Australia Pty Ltd
Applicant ACN: 092 020 178
Summary of use For nutritional management of overweight and mature dogs with severe dietary allergy
Date of registration/approval: 22 January 2015
Product registration no.: 70265
Label approval no.: 70265/62853
Application no.: 100386
Product name: Vets Choice For Small Cats And Kittens 0.5 kg To 2.5 kg Allwormer Spot-On
Active constituent/s: 21.4 g/L emodepside, 85.8 g/L praziquantel
Applicant name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of use For use in the treatment and control of intestinal parasites and lungworm in cats
Date of registration/approval: 27 January 2015
Product registration no.: 80201
Label approval no.: 80201/100386
Application no.: 62852
Product name: Hypoallergenic HSD 24 Small Dog Under 10 kg Canine – 10 kg
Active constituent/s: N/A
Applicant name: Royal Canin Australia Pty Ltd
Applicant ACN: 092 020 178
Summary of use For nutritional management of small-breed dogs with severe dietary allergies
Date of registration/approval: 28 January 2015
Product registration no.: 70264
Label approval no.: 70264/62852
Application no.: 62606
Product name: Matrix 6000 I.V. Injection
Active constituent/s: 10 mg/mL sodium hyaluronate
Applicant name: Randlab Australia Pty Ltd
Applicant ACN: 114 948 837
Summary of use For use in the treatment of lameness in horses
Date of registration/approval: 30 January 2015
Product registration no.: 70144
Label approval no.: 70144/62606
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 14
Veterinary Chemical Products and approved labels
3. VARIATIONS OF REGISTRATION
Application no.: 101467
Product name: Aristopet Animal Health Tea Tree Flea And Tick Spray For Dogs And Puppies
Active constituent/s: 6 g/L n-octyl bicycloheptene dicarboximide, 3.6 g/L piperonyl butoxide,
1.8 g/L pyrethrins
Applicant name: Aristopet Pty Ltd
Applicant ACN: 145 418 882
Summary of variation: To change the product name from ‘ARISTOPET FLEA & TICK SPRAY’ to ‘ARISTOPET ANIMAL HEALTH TEA TREE FLEA AND TICK SPRAY FOR DOGS AND PUPPIES’ and to remove use on cats
Date of variation: 21 January 2015
Product registration no.: 47181
Label approval no.: 47181/101467
Application no.: 101466
Product name: Aristopet Animal Health Tea Tree Antiseptic Ointment For Dogs
Active constituent/s: 30 mg/g melaleuca oil
Applicant name: Aristopet Pty Ltd
Applicant ACN: 145 418 882
Summary of variation: To change the product name from ‘ARISTOPET ANIMAL HEALTH TEA TREE ANTISEPTIC OINTMENT FOR DOGS, CATS AND HORSES’ to ‘ARISTOPET ANIMAL HEALTH TEA TREE ANTISEPTIC OINTMENT FOR DOGS’ and to remove use on cats and horses
Date of variation: 21 January 2015
Product registration no.: 47316
Label approval no.: 47316/101466
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 15
Approved Active Constituents
Approved Active Constituents
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals
Code Act 1994, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of
the approval of the following active constituents, with effect from the dates shown.
1. ACTIVE CONSITUTENT
Application no.: 100131
Active constituent/s: Methomyl
Applicant name: Du Pont (Australia) Pty Ltd
Applicant ACN: 000 716 469
Summary of use: For use in agricultural chemical products
Date of approval: 22 January 2015
Approval no.: 80050/100131
Application no.: 101452
Active constituent/s: Fluralaner
Applicant name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of use: For use in veterinary chemical products
Date of approval: 23 January 2015
Approval no.: 80697/101452
Application no.: 62734
Active constituent/s: Quinclorac
Applicant name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of use: For use in agricultural chemical products
Date of approval: 23 January 2015
Approval no.: 70207/62734
Application no.: 58262
Active constituent/s: Difenoconazole
Applicant name: Shandong Rainbow International Co., Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 29 January 2015
Approval no.: 68383/58262
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 16
Amendments to the APVMA MRL Standard
Amendments to the APVMA MRL Standard
The Australian Pesticides and Veterinary Medicines Authority (APVMA) approves maximum residue limits (MRLs) of
agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. The MRLs
approved by the APVMA are associated with a regulatory decision to register a product, grant a permit approval, or as an
outcome from a review decision and are set out in the Agricultural and Veterinary Chemicals Code Instrument No. 4
(MRL Standard) 2012. The MRL Standard lists MRLs of substances that may arise from the approved use of agricultural
and veterinary chemical products containing those substances on commodities used for human consumption as well as
livestock feeds. The MRL Standard also provides the relevant residue definitions to which these MRLs apply. There may
be situations where the residue definition for monitoring and enforcement is different to the definition used for dietary risk
assessment purposes.
MRLs are set at levels which are not likely to be exceeded if the agricultural or veterinary chemicals are used in
accordance with approved label instructions. In considering MRLs and variation to MRLs, the APVMA takes into account
studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice and dietary
exposure. In approving MRLs, the APVMA is satisfied, from dietary exposure assessment, that the levels set are not an
undue hazard to human health.
The APVMA has amended the MRL Standard with affect from 10 February 2014.
Details of the amendment can be found in the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL
Standard) Amendment Instrument 2015 (No. 1).
The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code Instrument
No. 4 (MRL Standard) 2012.
The MRL Standard is accessible via the ComLaw website www.comlaw.gov.au or the links above.
For further information please contact:
MRL Contact Officer
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4897
Fax: +61 2 6210 4840
Email: enquiries@apvma.gov.au
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 17
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
In the previous notice, the APVMA gazetted that amendments which it has approved varying maximum residue limits
(MRLs) for substances contained in agricultural and veterinary chemical products as set out as in the APVMA’s MRL
Standard, have been made.
Under Section 82 of the Food Standards Australia New Zealand Act 1991 the APVMA is proposing to incorporate those
variations (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2015
(No. 1)) to MRLs into Standard 1.4.2. Maximum Residue Limits of the Australia New Zealand Food Standards Code.
MRLs contained in Standard 1.4.2 provide the limits for residues of agricultural and veterinary chemicals that may
legitimately occur in foods. By this means, Standard 1.4.2 permits the sale of treated foods and protects public health
and safety by minimising residues in foods consistent with the effective control of pests and diseases.
The APVMA and FSANZ are satisfied, based on dietary exposure assessments and current health standards, that the
proposed limits are not harmful to public health.
The Agreement between the Government of Australia and the Government of New Zealand concerning a Joint Food
Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food
standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary
chemicals in food.
Food Standards Australia New Zealand (FSANZ) will make a Sanitary and Phytosanitary (SPS) notification to the World
Trade Organization (WTO).
The APVMA invites comment on these proposals. Details on how to make a submission appear near the end of this
notice, below the details of the proposed amendment.
The APVMA will consider any public comments made in response to this proposal. If the APVMA decides to proceed with
the proposal, it will further notify any variations it makes to Standard 1.4.2 in the APVMA Gazette. The variations will take
effect as from the date of that subsequent notice.
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 18
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
DRAFT VARIATIONS TO THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE
Note: The following amendments are in a format that accords with the proposed amending Legislative Instrument
which, in turn, has to be consistent with the existing format of Standard 1.4.2 (Maximum Residue Limits) of the
Australia New Zealand Food Standards Code.
PROPOSED AMENDMENT (AGRICULTURAL AND VETERINARY CHEMICALS CODE INSTRUMENT NO. 4 (MRL
STANDARD) AMENDMENT INSTRUMENT 2015 (NO. 1))
Note: Subsection 82(2) of the Food Standards Australia New Zealand Act 1991 provides that variations to standards
are legislative instruments, but are not subject to disallowance or sunsetting.
To commence: on gazettal of variation Standard 1.4.2 of the Australia New Zealand Food Standards Code is varied by – 1. omitting from Schedule 1 the chemical residue definition for Trinexapac-ethyl and substituting the following
chemical residue definition-
Trinexapac acid
2. inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals –
Bifenthrin
Bifenthrin
Almonds T0.1
Chlorantraniliprole
Plant commodities and animal commodities other than milk: Chlorantraniliprole
Milk: Sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide,
and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide,
expressed as chlorantraniliprole
Root and tuber vegetables T0.05
Cypermethrin
Cypermethrin, sum of isomers
Fruiting vegetables, cucurbits T0.3
Dithiocarbamates
Total dithiocarbamates, determined as carbon disulphide evolved during acid digestion and
expressed as milligrams of carbon disulphide per kilogram of food
Olives T2
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 19
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Hexythiazox
Hexythiazox
Fruiting vegetables, cucurbits T0.05 Fruiting vegetables, other than
cucurbits [except mushrooms and sweet corn (corn-on-the-cob)]
T1
Potato T*0.02
Sulfoxaflor
Sulfoxaflor
Cherimoya T1 Custard apple T1 Ilama T1 Soursop T1 Sugar apple T1
Penflufen
Penflufen
Cotton seed T*0.01
Pyraclostrobin Commodities of plant origin: Pyraclostrobin
Commodities of animal origin: Sum of pyraclostrobin and metabolites hydrolysed to 1-(4-chloro-phenyl)-
1H-pyrazol-3-ol, expressed as pyraclostrobin
Olives T1
Trifloxystrobin
Sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)-
ethylideneaminooxymethyl]phenyl] acetic acid), expressed as trifloxystrobin equivalents
Cotton seed T*0.01
Thiamethoxam Commodities of plant origin: Thiamethoxam
Commodities of animal origin: Sum of thiamethoxam
and N-(2-chloro-thiazol-5-ylmethyl)-N′-methyl-N′-nitro-guanidine, expressed as thiamethoxam
Beans, except broad bean and soya bean
T0.2
Fruiting vegetables, cucurbits T1 Root and tuber vegetables T0.7
Trinexapac-ethyl
4-(cyclopropyl--hydroxy-methylene)-3,5-dioxo-cyclohexanecarboxylic acid
Bran, unprocessed of cereal grains 0.5 Cereal grains 0.2 Eggs *0.01 Poultry, edible offal of *0.01 Poultry meat *0.01
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 20
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
3. omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –
Chlorantraniliprole Plant commodities and animal commodities other
than milk: Chlorantraniliprole Milk: Sum of chlorantraniliprole, 3-bromo-N-[4-chloro-
2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide,
and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide,
expressed as chlorantraniliprole
Potato *0.01 Radish T0.05 Swede T0.05 Turnip, Garden T0.05
Cypermethrin
Cypermethrin, sum of isomers
Cucumber T0.3
Hexythiazox
Hexythiazox
Cucumber T1 Peppers, Sweet T1 Tomato T1
Trinexapac-ethyl
4-(cyclopropyl--hydroxy-methylene)-3,5-dioxo-cyclohexanecarboxylic acid
Barley T0.3 Oats T0.3 Wheat T0.3
4. omitting from Schedule 1, under the entries for the following chemicals, the maximum residue limit for the food, substituting –
Abamectin
Sum of avermectin B1a, avermectin B1b and (Z)-8,9 avermectin B1a, and (Z)-8,9 avermectin B1b
Almonds *0.01
Pyrimethanil
Pyrimethanil
Tomato 1
Pyroxasulfone
Commodities of plant origin: Sum of pyroxasulfone and (5-difluoromethoxy-1-methyl-3-trifluoromethyl-
1H-pyrazol-4-yl)methanesulfonic acid, expressed as pyroxasulfone
Commodities of animal origin: 5-Difluoromethoxy-1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxylic
acid, expressed as pyroxasulfone
Pulses *0.01
Sulphadimidine
Sulphadimidine
Eggs *0.005
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 21
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Thiamethoxam Commodities of plant origin: Thiamethoxam
Commodities of animal origin: Sum of thiamethoxam and N-(2-chloro-thiazol-5-ylmethyl)-N′-methyl-N′-
nitro-guanidine, expressed as thiamethoxam
Fruiting vegetables, other than cucurbits
T0.5
Trimethoprim
Trimethoprim
Eggs *0.01
INVITATION FOR SUBMISSIONS
Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the
proposal to vary Standard 1.4.2 Maximum Residue Limits of the Australia New Zealand Food Standards Code.
Submissions should be strictly confined to relevant matters that the APVMA must consider (such as public health and
safety) which are associated with the occurrence of the proposed residues in foods. Comments received outside these
grounds will not be considered by the APVMA. Claims made in submissions should be supported wherever possible by
referencing or including relevant studies, research findings, trials, surveys etc. Technical information should be in
sufficient detail to allow independent scientific assessment.
Please note that FSANZ will make a SPS notification to the WTO and submissions related to impacts on international
trade should be made to FSANZ in response to that notification.
Submissions must be made in writing and should be clearly marked as a ‘submission on the proposed amendment to
Standard 1.4.2’ and quote the correct amendment number.
DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (AEDT) 10 March 2015 SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL ONLY BE CONSIDERED BY PRIOR ARRANGEMENT
Submissions received after this date will only be considered if agreement for an extension has been given prior to this
closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to
the submission period.
For further information please contact:
MRL Contact Officer
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4897
Fax: +61 26210 4840
Email: enquiries@apvma.gov.au
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 22
Cancellation of Approval at the Request of the Holder
Cancellation of Approval at the Request of the Holder
At the request of the holder, the APVMA has cancelled a label approval for the following products:
Product
no.
Product name Approval holder Cancelled label
approval
Date of effect
53722 SMASH 500 LOW ODOUR
SELECTIVE HERBICIDE
IMTRADE AUSTRALIA
PTY LTD
53722/0214
53722/0301
53722/0805
4 February 2015
60857 SENATOR 600 FLOWABLE
SEED TREATMENT
CROP CARE
AUSTRALASIA PTY LTD
60857/61992 4 February 2015
68917 KELPIE RICO 450 GLY
HERBICIDE
SINOCHEM
INTERNATIONAL
AUSTRALIA PTY LTD
68917/100609 4 February 2015
The following instructions set out how a person can deal with the product bearing the cancelled labels.
SUPPLY
A person may supply or cause to be supplied product bearing the cancelled label manufactured prior to 4 February 2015
at wholesale and retail level, until 4 February 2016.
After 4 February 2016 it will be an offence against the Agvet Codes to have possession or custody of the product bearing
the cancelled label with the intention to supply, or to supply the product bearing the cancelled label.
USE
A person may continue to use the product bearing the cancelled label according to its label instructions until
4 February 2016.
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 bearing the cancelled label after the approval has been cancelled until
4 February 2016.
The supply and use of the product bearing the cancelled label must be in accordance with the conditions of registration
or approval, including any conditions relating to the shelf life or expiry date.
It is an offence to possess, have custody of, use, or deal with the product bearing the cancelled label listed in the table in
a manner that contravenes the above instructions.
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 23
Cancellation of Approval at the Request of the Holder
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 4776
Email: chemicalreview@apvma.gov.au
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 24
Cancellation of Active Constituent Approval at the Request of the Holder
Cancellation of Active Constituent Approval at the Request of the Holder
At the request of the holder, the APVMA has cancelled the approval of the following active constituent:
Active no. Active name Approval holder Date of effect
48731 DIETHYLTOLUAMIDE VERTELLUS PERFORMANCE
MATERIALS INC
23 January 2015
The following instructions set out how a person can deal with the cancelled active constituent.
SUPPLY
A person may supply or cause to be supplied active constituent manufactured prior to 23 January 2015 at wholesale and
retail level, until the 23 January 2016.
After 23 January 2016 it will be an offence against the Agvet Codes to have possession or custody of the active
constituent with the intention to supply, or to supply the active constituent.
USE
Any person who possesses, has custody of, uses, or otherwise deals with the listed active constituent in accordance with
the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of,
use or otherwise deal with the active constituent from the time the approval has been cancelled up until 23 January 2016.
The supply and use of the active constituent must be in accordance with the conditions of approval, including any
conditions relating to the shelf life or expiry date.
It is an offence to possess, have custody of, use, or deal with the active constituent 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
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
SYMONSTON ACT 2609
Phone: +61 2 6210 4749
Fax: +61 2 6210 4776
Email: chemicalreview@apvma.gov.au
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 25
Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene
Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene
Quintozene containing products have been suspended since 9 April 2010 on the basis of human health concerns due to
the potential presence of undeclared dioxin impurities. The current suspension expires on 14 February 2015.
The APVMA has decided to extend the suspension of the active constituent approvals for quintozene listed in Table 1
and the product registrations and label approvals of products containing quintozene listed in Table 2.
Table 1: Active constituent approvals for quintozene
Approval Number Approval Holder
53706 Amvac Chemicals Corporation
Table 2: Registered products containing quintozene
Product
Number
Product Name Label Approval
Numbers
Registrant
41110 Barmac Turf Renovation Mixture 41110/0203 Amgrow Pty Ltd
45883 Uniroyal Chemical Terraclor Super-X E.C.
Soil Fungicide
45883/0903 Barmac Industries Pty Ltd
47211 Barmac Chloroturf Dg Fungicide 47211/1102
47211/3427
Amgrow Pty Ltd
48308 Barmac Rhysol Dg Turf Fungicide 48308/01
48308/0400
Amgrow Pty Ltd
50787 Uniroyal Chemical Cotton Planter Box
Protectant
50787/0498
50787/0603
Barmac Industries Pty Ltd
50788 Uniroyal Chemical Peanut Seed
Protectant Fungicide
50788/0898
50788/0903
Amgrow Pty Ltd
50789 Uniroyal Chemical Terraclor Cotton Seed
Protectant
50789/0300
50789/0498
Amgrow Pty Ltd
513821 Optimerge Peanut Seed Dressing 51382/0106
51382/1298
Peanut Company Of
Australia Limited
53533 Terraclor Soil Fungicide 53533/0201
53533/0403
53533/0702
53533/0703
53533/1100
53533/1206
Amgrow Pty Ltd
55743 Terraclor Seed Treatment 55743/0105
55743/1106
Amgrow Pty Ltd
1 A permit (PER 14681) has been issued for certain batches of this product.
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 26
Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene
The active constituent approval suspension is in effect from 14 February 2015 until 13 November 2015.
The product and label suspensions apply as a consequence of the decision to continue the suspension of quintozene
active constituent approval and are in effect from 14 February 2015 until 13 November 2015.
BASIS FOR THE CONTINUATION OF THE SUSPENSION
The APVMA became aware of information in 2009 indicating the presence of undeclared dioxins as impurities in
products that contain quintozene as the active constituent. On this basis, the APVMA suspended quintozene active
approvals effective from 9 April 2010 until 14 July 2014. The APVMA has decided to continue this suspension for a
further year until 13 November 2015.
Dioxins are listed as toxicologically significant impurities in the Definition of Standards for Active Constituents (see
www.apvma.gov.au/node/10706). The presence of any impurity that is listed as toxicologically significant is a matter that
the APVMA considers to be a relevant particular to the approval of an active constituent. An active constituent approval
is not supportable unless any impurities of toxicological significance have been declared, quantified and evaluated.
The APVMA considers that the active constituent quintozene may be an undue hazard to the safety of people exposed to
it during its handling and may have an effect that is harmful to human beings. A full assessment of the dioxin impurities
has not been conducted in accordance with section 14 of the Agvet Code Act. On this basis the APVMA has concluded
that it cannot allow the active constituent to be supplied and used in chemical products when it contains undeclared
dioxins. Consequently, based on section 41(1)(b) of the Agvet Code Act, the APVMA has suspended the approvals of
quintozene active constituents.
The Agvet Code provides that if the APVMA suspends the only approval, or all the approvals, of an active constituent for
an existing chemical product, it must also suspend any registration of that product. In addition, if the APVMA suspends
the registration of a chemical product, it may also suspend any approval relating to a label for containers for the product.
INSTRUCTIONS FOR DEALING WITH SUSPENDED ACTIVE CONSTITUENTS AND PRODUCTS2
Unless authorised by the APVMA, the following instructions apply to persons having possession or custody of stocks,
and are considering using or otherwise dealing with suspended active constituent and product during the period of
suspension.
INSTRUCTIONS FOR POSSESSING, HAVING CUSTODY OF, USING OR DEALING WITH SUSPENDED ACTIVE
CONSTITUENTS AND PRODUCTS
Possession and custody
Possession and custody of existing stocks of quintozene active constituent and/or products is permitted.
Supply
No supply of the active constituent quintozene and/or any product that contains it as an active constituent is permitted.
Use
No use of suspended product containing quintozene is permitted
2 With the exception of permit; PER14681.
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 27
Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene
Any person who possesses or has custody of, or otherwise deals with the active constituents or products listed in Tables
1 and 2 (above) in accordance with the instructions in this notice is taken to have been issued with a permit to possess,
have custody of, or deal with the active constituents or products during the period of suspension or until further notice.
WARNING
A person must not possess with the intent to supply, or deal with any materials containing quintozene during this period,
except in accordance with the instructions contained in this notice. A failure to comply with these instructions will result in
an offence against the Agvet Codes and the APVMA will take appropriate compliance action. It is an offence for any
person to possess with the intent to supply, use or deal with the active constituent after 9 April 2010 unless authorised to
do so by the APVMA. Similarly, it is an offence for any person to possess with the intent to supply, use or deal with
quintozene products after 9 April 2010, unless authorised to do so by the APVMA.
APVMA CONTACT
For further information please contact:
Chemical Review Liaison Officer
Scientific Assessment and Chemical Review
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4749
Fax: +61 2 6210 4840
Email: chemicalreview@apvma.gov.au
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 28
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer
Licensing of Veterinary Chemical Manufacturers
Licensing of Veterinary Chemical Manufacturers
Pursuant to Part 8 of the Agricultural and Veterinary Chemical Codes scheduled to the Agricultural and Veterinary
Chemicals Code Act 1994, the APVMA hereby gives notice that it has taken action, with respect to the licensing of the
following veterinary chemical manufacturers, with effect from the dates shown.
For a comprehensive listing of all licensed manufacturers please see the APVMA’s website www.apvma.gov.au.
1. NEW LICENCES
The APVMA has issued the following licences under subsection 123(1) of the Agricultural and Veterinary
Chemicals Code [the Agvet Code]
SYRINX PHARMACEUTICALS
PTY LTD
LICENCE NO: 2227
ACN: 149 728 825
110 Merrindale Drive
CROYDON VIC 3136
Product Types:*
Category 2: Tablets, capsules (hard shell), creams/lotions, liquids,
powders and granules
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, dry milling, wet milling, granulation, filling, packaging, labelling,
blister and sachet packaging, tableting, tablet coating, capsule filling from bulk,
freeze drying, storage and release for supply
Licence Issued: 8 December 2014
2. CHANGES TO EXISTING LICENCES
The APVMA has issued the following licences under subsection 123(1) of the Agricultural and Veterinary
Chemicals Code [the Agvet Code
MAVLAB CONTRACT
MANUFACTURING PTY LTD
LICENCE NO: 6188
ACN: 164 339 986
29–33 Rowland Street
SLACKS CREEK QLD 4127
Product Types: *
Category 6: Single step manufacture
Step(s) of Manufacture: Storage and release for supply
Amended Licence Issued: 18 November 2014
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 29
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer
Licensing of Veterinary Chemical Manufacturers
JUROX PTY LIMITED LICENCE NO: 1042
ACN: 000 932 230
85 Gardiner Street
RUTHERFORD NSW 2320
Product Types: *
Category 1: Sterile products
Category 2: Tablets, creams/lotions, ointments, pastes, powders, sprays,
liquids and suspensions
Category 3: Liquids, pastes, suspensions, sprays and powders
Step(s) of Manufacture: Quality assurance (QA) of raw materials, chemical
synthesis, formulation including blending, granulation, wet milling, dry milling,
filling, aseptic filling, packaging, labelling, strip, blister or sachet packaging,
tableting, tablet coating, sterilisation (heat and filtration), microbiological reduction
treatment (heat and filtration), analysis and testing (physical, chemical,
microbiological, sterility and endotoxin testing), storage and release for supply
Amended Licence Issued: 19 November 2014
THE STATE OF QUEENSLAND
ACTING THROUGH THE
DEPARTMENT OF
AGRICULTURE, FISHERIES
AND FORESTRY
LICENCE NO: 1018
ABN: 66 934 348 189
Tick Fever Centre
280 Grindle Road
WACOL QLD 4076
Product Types: *
Category 1: Immunobiologicals
Step(s) of Manufacture: Quality assurance (QA) of raw materials, management
and inoculation of donor animals, blood collection, formulation including blending,
aseptic filling, filling, packaging, labelling, sterilisation (heat and filtration),
microbiological reduction treatment (heat and filtration), analysis and testing
(physical, sterility, microbiological, serological and other pharmacological test),
storage and release for supply.
Amended Licence Issued: 25 November 2014
DERMCARE-VET PTY. LTD. LICENCE NO: 1052
ACN: 010 280 010
22 Aranda Street
SPRINGWOOD QLD 4127
Product Types: *
Category 1: Sterile and immunobiological products
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, filling, aseptic filling, packaging, labelling, analysis and testing
(physical), storage and release for supply
Amended Licence Issued: 18 November 2014
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 30
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer
Licensing of Veterinary Chemical Manufacturers
PHIBRO ANIMAL HEALTH PTY
LIMITED
LICENCE NO: 6121
ACN: 093 869 991
Unit 4; 129 Magowar Road
GIRRAWEEN NSW 2145
Product Types: *
Category 6: Single step manufacture
Step(s) of Manufacture: Quality assurance (QA) of raw materials, Quality
assurance (QA) of packaging materials, storage and release for supply
Amended Licence Issued: 20 November 2014
TREND LABORATORIES PTY
LTD
LICENCE NO: 2169
ACN: 001 627 103
1 Corella Close
BERKELEY VALE NSW 2261
Product Types: *
Category 2: Liquids
Category 3: Liquids, sprays, powders
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, filling, packaging, labelling, sachet packaging, analysis and
testing (physical, chemical and microbiological), storage and release for supply
Amended Licence Issued: 8 December 2014
ULTRA MIX (AUST.) PTY.
LTD.
LICENCE NO: 2203
ACN: 067 526 596
6 McArthur Street
WEST FOOTSCRAY VIC 3012
Product Types:*
Category 2: Creams/lotions, liquids, suspensions and gels.
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, filling, packaging, labelling, storage and release for supply
Amended Licence Issued: 9 December 2014
ANNEX HOLDINGS PTY LTD LICENCE NO: 6141
ACN: 080 349 828
114 Fairbank Road
CLAYTON SOUTH VIC 3169
Product Types: *
Category 6: Single step manufacture
Step(s) of Manufacture: Secondary packaging, secondary labelling,
repackaging, relabelling, storage
Amended Licence Issued: 12 December 2014
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 31
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer
Licensing of Veterinary Chemical Manufacturers
BIOPROTON PTY. LTD. LICENCE NO: 4096
ACN: 059 093 417
55 Dulacca Street
ACACIA RIDGE QLD 4110
Product Types: *
Category 4: Enzyme supplements
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, packaging, labelling, analysis and testing (enzyme assay),
storage and release for supply.
Amended Licence Issued: 16 December 2014
ARISTOPET PTY LTD LICENCE NO: 2211
ACN: 145 418 882
118 Links Avenue South
EAGLE FARM QLD 4009
Product Types: *
Category 2: Tablets, creams/lotions, ointments, pastes, powders, sprays,
liquids and suspensions.
Category 3: Liquids, sprays, powders and tablets (soluble for aquarium)
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, dry milling, granulation, filling, packaging, labelling, blister
packaging, tableting, analysis and testing (physical), storage and release for
supply.
Amended Licence Issued: 16 December 2014
RANVET PTY. LIMITED LICENCE NO: 2167
ACN: 001 606 033
10–12 Green Street
BANKSMEADOW NSW 2019
Product Types: *
Category 2: Powders and liquids
Category 4: Supplements
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, filling, packaging, labelling, storage and release for supply.
Amended Licence Issued: 16 December 2014
ENDEAVOUR FOUNDATION LICENCE NO: 6161
ACN: 009 670 704
12–16 Leabons Lane
SEVEN HILLS NSW 2147
Product Types: *
Category 6: Single step manufacture
Step(s) of Manufacture: Packaging, labelling, strip, blister or sachet packaging,
storage and release for supply
Amended Licence Issued: 16 December 2014
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 32
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer
Licensing of Veterinary Chemical Manufacturers
AMS LABORATORIES PTY.
LIMITED
LICENCE NO: 6139
ACN: 075 467 757
8 Rachael Close
SILVERWATER NSW 2128
Product Types: *
Category 6: Single step manufacture
Step(s) of Manufacture: Analysis and testing (Limulus Amoebocyte Lysate test
[LAL], antibiotic assay, sterility and microbiological).
Amended Licence Issued: 16 December 2014
SCENTAL PACIFIC PTY. LTD. LICENCE NO: 2112
ACN: 073 481 419
53 Jersey Road
BAYSWATER VIC 3153
Product Types: *
Category 2: Creams/lotions, ointments, gels, pastes, sprays and liquids
Category 3: Liquids, pastes and sprays
Step(s) of Manufacture: Formulation including blending, filling, packaging,
labelling, strip, blister or sachet packaging, analysis and testing (physical and
chemical), storage and release for supply.
Amended Licence Issued: 18 December 2014
COSMETIC MANUFACTURERS
(AUST) PTY. LTD.
LICENCE NO: 2176
ACN: 010 501 327
14 Kingston Drive
HELENSVALE QLD 4212
Product Types: *
Category 2: Creams/lotions, sprays, liquids, gels and ointments.
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, filling, packaging, labelling and release for supply.
Amended Licence Issued: 19 December 2014
THE STATE OF QUEENSLAND
ACTING THROUGH THE
DEPARTMENT OF
AGRICULTURE, FISHERIES
AND FORESTRY
LICENCE NO: 6175
ABN: 66 934 348 189
Biosecurity Sciences Laboratory
Health and Food Sciences
Precinct
39 Kessels Road
COOPERS PLAINS QLD 4108
Product Types: *
Category 6: Single step manufacture
Step(s) of Manufacture: Analysis and testing (serological, immunological,
virological (vaccine potency and purity testing).
Amended Licence Issued: 19 December 2014
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 33
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer
Licensing of Veterinary Chemical Manufacturers
ADVANCED FEEDS PTY LTD LICENCE NO: 2117
ACN: 009 403 623
13 Meliador Way
MIDVALE WA 6056
Product Types: *
Category 2: Pastes and powders
Category 4: Premixes
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, filling, packaging, labelling, storage and release for supply.
Amended Licence Issued: 23 December 2014
3. LICENCE CANCELLATIONS
The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary
Chemicals Code [the Agvet Code].
HAIR ADVISORY CENTRE PTY
LTD TRADING AS
QUEENSLAND COSMETIC
LABORATORIES
LICENCE NO: 2037
ACN: 002 385 122
28 Horizon Drive
BEENLEIGH QLD 4207
Date Cancelled: 20 November 2014
P.R. DAVOREN
LABORATORIES PTY. LTD.
ACN: 004 852 019
26 Parkhurst Drive
KNOXFIELD VIC 3180
LICENCE NO: 2100
Date Cancelled: 20 November 2014
MAVLAB PTY. LTD. LICENCE NO: 1009
ACN: 009 708 187
29–33 Rowland Street
SLACKS CREEK QLD 4127
Date Cancelled: 3 December 2014
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 34
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer
Licensing of Veterinary Chemical Manufacturers
INTEC CORPORATION PTY
LTD
LICENCE NO: 1050
ACN: 087 935 046
8 Mosrael Place
ROWVILLE VIC 3178
Date Cancelled: 3 December 2014
ACCESS INDUSTRIES FOR
THE DISABLED LTD
LICENCE NO: 6056
ACN: 001 797 511
Units 10 & 11
167 Prospect Highway
SEVEN HILLS NSW 2147
Date Cancelled: 3 December 2014
ALPHA CHEMICALS PTY LTD LICENCE NO: 3032
ACN: 001 174 471
18 Inman Road
CROMER NSW 2099
Date Cancelled: 3 December 2014
ORTHOMOLECULAR
MEDISEARCH
LABORATORIES PTY LTD
TRADING AS BIOLOGICAL
THERAPIES
LICENCE NO: 1043
ACN: 006 897 856
Units 3, 9–11, 20–30 Malcolm
Road
BRAESIDE VIC 3195
Date Cancelled: 3 December 2014
Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 35
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer
Licensing of Veterinary Chemical Manufacturers
QUEENSLAND BIOCHEMICS
PTY LTD
LICENCE NO: 2101
ACN: 010 131 030
15 Lisgar Street
VIRGINIA QLD 4014
Date Cancelled: 9 December 2014
4. REVOCATION OF LICENCE CANCELLATION
The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agricultural and
Veterinary Chemicals Code [the Agvet Code].
ULTRA MIX (AUST.) PTY. LTD. LICENCE NO: 2203
ACN: 067 526 596
6 McArthur Street
WEST FOOTSCRAY VIC 3012
Date Cancellation Revoked: 9 December 2014
APVMA CONTACT
GMP Officer
Manufacturing, Quality and Licensing
Legal and Compliance Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4899
Fax: +61 2 6210 4813
Email: mls@apvma.gov.au