APVMA Gazette No. 3, 10 February 2015 · Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10...

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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

Transcript of APVMA Gazette No. 3, 10 February 2015 · Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10...

Page 1: APVMA Gazette No. 3, 10 February 2015 · Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 7 Agricultural

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

Page 2: APVMA Gazette No. 3, 10 February 2015 · Commonwealth of Australia Gazette No. APVMA 3, Tuesday, 10 February 2015 Agricultural and Veterinary Chemicals Code Act 1994 7 Agricultural

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: [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 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.

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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.

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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: [email protected]

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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.

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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

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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

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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

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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: [email protected]

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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.

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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: [email protected]

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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: [email protected]

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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.

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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.

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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: [email protected]

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* 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

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* 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

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* 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

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* 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

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* 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

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* 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

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* 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

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* 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: [email protected]