apvma gazette no. 7, 4 april 2017. apvma 7, tuesday, 4 april 2017 published by the australian...

No. APVMA 7, Tuesday, 4 April 2017 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 7, Tuesday, 4 April 2017 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2017

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:

Director, Public Affairs and Communications

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

Kingston ACT 2604

Email: [email protected]

Website: www.apvma.gov.au.

GENERAL INFORMATION

The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of

the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as 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 activity in

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

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www.apvma.gov.au/news-and-publications/publications/gazette

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

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CONTENTS

Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and Approved Labels .................................................................................................... 12 Approved Active Constituents ....................................................................................................................................... 18 Approved Active Constituents—Section 14A ................................................................................................................ 19 Approved Active Constituents—Section 14 ................................................................................................................... 29 New Chemical Product Talinor Herbicide Containing Bicyclopyrone ............................................................................ 32


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.: 107751 Product name: Genfarm Metalaxyl-M 350 Seed Treatment Active constituent/s: 350 g/L metalaxyl-m Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For the control of seedling diseases caused by pythium and phytophthora in cotton,

peas, lucerne, subterranean clover, carrots, beetroot, maize, sweet corn and radish. Also for the disinfection of fusarium wilt on cotton seeds

Date of registration: 10 March 2017 Product registration no.: 83221 Label approval no.: 83221/107751

Application no.: 108069 Product name: Glufonium 200 SL Herbicide Active constituent/s: 200 g/L glufosinate-ammonium Applicant name: Sinon Australia Pty Limited Applicant ACN: 102 741 024 Summary of use For the non-residual control of broadleaf and grassweeds in various situations Date of registration: 10 March 2017 Product registration no.: 83334 Label approval no.: 83334/108069

Application no.: 108160 Product name: Sharda Chlorpyrifos 500 Insecticide Active constituent/s: 500 g/L chlorpyrifos (an anti-cholinesterase compound) Applicant name: Sharda Cropchem Espana S.L Applicant ACN: NA Summary of use: For the control of a wide range of insect pests on fruit, vegetables, oilseeds, cotton,

cereals, pasture, turf and other situations Date of registration: 15 March 2017 Product registration no.: 83386 Label approval no.: 83386/108160

Application no.: 106067 Product name: Relyon Glyphix Max 540 Herbicide. Active constituent/s: 540 g/L glyphosate (present as the potassium salt) Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use: For the control of many annual and perennial weeds in various situations Date of registration: 15 March 2017 Product registration no.: 82560 Label approval no.: 82560/106067



Application no.: 108281 Product name: Sinozeb 750 WG Fungicide Active constituent/s: 750 g/kg mancozeb Applicant name: Sinon Australia Pty Limited Applicant ACN: 102 741 024 Summary of use: For the control of certain fungal diseases of fruit, field crops, tobacco, turf, vegetables

and ornamentals Date of registration: 15 March 2017 Product registration no.: 83438 Label approval no.: 83438/108281

Application no.: 108091 Product name: Conan 720 Fungicide Active constituent/s: 720 g/L chlorothalonil Applicant name: UPL Australia Limited Applicant ACN: 066 391 384 Summary of use: For the control of fungal diseases in various crops and situations Date of registration: 15 March 2017 Product registration no.: 83344 Label approval no.: 83344/108091

Application no.: 108164 Product name: Ultraphos NF Phosphine Fumigant Active constituent/s: 20 g/kg phosphine Applicant name: Specialty Gases Pty Ltd Applicant ACN: 161 156 403 Summary of use: For the control of insect pests in produce and buildings Date of registration: 15 March 2017 Product registration no.: 83388 Label approval no.: 83388/108164

Application no.: 107933 Product name: Ozcrop Clethodim 360 EC Herbicide Active constituent/s: 360 g/L clethodim, Applicant name: Ozcrop Pty Ltd Applicant ACN: 160 656 431 Summary of use: For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas,

cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans


Application no.: 108112 Product name: Weed Force Gusto Woody Weed Herbicide Active constituent/s: 300 g/L triclopyr present as the butoxyethyl ester, 100 g/L picloram present as

hexyloxypropylamine salt Applicant name: Weed Force Pty Ltd Applicant ACN: 602 207 152 Summary of use: For the control of a range of environmental and noxious woody and herbaceous weeds Date of registration: 15 March 2017 Product registration no.: 83353 Label approval no.: 83353/108112



Application no.: 105783 Product name: Muskil Soft Bait with Two Actives for Faster Kill of Rats & Mice Active constituent/s: 0.025 g/kg difenacoun, 0.025 g/kg bromadiolone Applicant name: Zapi S.P.A Applicant ACN: N/A Summary of use: For control of rats and mice around industrial, commercial, public services, agricultural

and residential buildings Date of registration: 15 March 2017 Product registration no.: 82450 Label approval no.: 82450/105783

Application no.: 57569 Product name: Eco-Slasher Weed, Moss & Algae Killer Active constituent/s: 36.8 g/L nonanoic acid Applicant name: Organic Crop Protectants Pty Ltd Applicant ACN: 003 149 719 Summary of use: For non-selective control of weeds, grasses, moss and algae in home garden

situations Date of registration: 15 March 2017 Product registration no.: 68128 Label approval no.: 68128/57569

Application no.: 106013 Product name: 4Farmers Prosulfocarb Herbicide Active constituent/s: 800 g/L prosulfocarb Applicant name: 4 Farmers Australia Pty Ltd Applicant ACN: 160 092 428 Summary of use: For the control of annual ryegrass (lolium rigidum) in wheat Date of registration: 16 March 2017 Product registration no.: 82536 Label approval no.: 82536/106013

Application no.: 106711 Product name: UpCell Plant Growth Regulator Active constituent/s: 19 g/L gibberellins A4 and A7 and 19 g/L 6-benzyladenine Applicant name: Agritrading Pty Limited Applicant ACN: 134 291 295 Summary of use: For the improvement of fruit shape/typiness in apples, for use in thinning in apples

when used in combination with a 20 g/L 6-benzyladenine (6–BA) plant growth regulator, for thinning of red Delicious and Gala apples in combination with NAA and also for promotion of lateral growth in red Delicious apples and cherries


Application no.: 108180 Product name: Relyon Jekyll Snail and Slug Killer Active constituent/s: 15 g/kg metaldehyde Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use: For the control of snails and slugs in many agricultural and horticultural situations Date of registration: 17 March 2017 Product registration no.: 83398 Label approval no.: 83398/108180



Application no.: 102300 Product name: Cavalier 500 SC Herbicide Active constituent/s: 500 g/L oxyfluorfen Applicant name: Adama Australia Pty Limited Applicant ACN: 050 328 973 Summary of use: For the control of broadleaf weeds and some grasses in a range of cropping and

forestry situations Date of registration: 17 March 2017 Product registration no.: 81077 Label approval no.: 81077/102300

Application no.: 108185 Product name: Relyon Metola-S 960 Herbicide Active constituent/s: 960 g/L s-metolachlor Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use: For the control of certain annual grasses and broadleaf weeds in certain crops Date of registration: 17 March 2017 Product registration no.: 83401 Label approval no.: 83401/108185

Application no.: 109206 Product name: Searles Ant, Spider & Cockroach Killer Active constituent/s: 100 g/L permethrin 25:75 Applicant name: J C & A T Searle Pty Ltd Applicant ACN: 002 898 893 Summary of use: For control of ants, spiders, cockroaches, fleas and other household insects Date of registration: 17 March 2017 Product registration no.: 83894 Label approval no.: 83894/109206

Application no.: 108307 Product name: Sinoxypyr 200 EC Herbicide Active constituent/s: 200 g/L fluroxypyr present as the methyl heptyl ester Applicant name: Sinon Australia Pty Limited Applicant ACN: 102 741 024 Summary of use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, millets,

pastures, sorghum, sugar cane, sweet corn, winter cereals. Also for the control of woody weeds in agricultural non-crop areas, commercial and industrial areas, pastures and rights-of-way


Application no.: 108241 Product name: eChem Chlorpyrifos 500 Insecticide Active constituent/s: 500 g/L chlorpyrifos Applicant name: Echem (Aust) Pty Limited Applicant ACN: 089 133 095 Summary of use: For the control of a wide range of insect pests on fruit, vegetables, oilseeds, cotton,

cereals, pasture, turf and other situations Date of registration: 20 March 2017 Product registration no.: 83426 Label approval no.: 83426/108241



Application no.: 105780 Product name: Bye Bye Bugs Household Pest Control Active constituent/s: 0.5 g/L bifenthrin Applicant name: Wet And Forget Ltd Applicant ACN: N/A Summary of use: For the control of insect pests in outdoor situations around the home Date of registration: 20 March 2017 Product registration no.: 82449 Label approval no.: 82449/105780

Application no.: 105650 Product name: Genfarm Propyzamide 900 WG Herbicide Active constituent/s: 900 g/kg propyzamide Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For selective control of certain grasses and broadleaf weeds in lettuce, sports turf,

home lawns and legume seed crops and pastures Date of registration: 20 March 2017 Product registration no.: 82397 Label approval no.: 82397/105650

Application no.: 108106 Product name: Weed Force Broad Sweep Broadleaf Herbicide Active constituent/s: 340 g/L MCPA (present as the dimethylamine salt), 80 g/L dicamba (present as the

dimethylamine salt) Applicant name: Weed Force Pty Ltd Applicant ACN: 602 207 152 Summary of use: For the control of certain broadleaf weeds in winter cereals, pastures, turf and non-crop

areas Date of registration: 23 March 2017 Product registration no.: 83350 Label approval no.: 83350/108106

Application no.: 105481 Product name: Restrain Advance 400 Herbicide Active constituent/s: 400 g/L fluroxypyr present as the methylheptyl ester Applicant name: Grow Choice Pty Limited Applicant ACN: 069 839 961 Summary of use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, pastures,

poppies, sorghum, sugar cane, sweet corn, winter cereals. Also for the control of woody weeds in agricultural non-crop areas, commercial and industrial areas, forests, pastures and rights-of-way




Application no.: 107292 Product name: Agsure Dicamba 500 Herbicide Active constituent/s: 500 g/L dicamba present as the dimethylamine salt Applicant name: Elders Rural Services Australia Limited Applicant ACN: 004 045 121 Summary of use: For the control of certain broadleaf weeds in winter cereals, pastures, conservation tillage,

sugarcane, turf, rice, grain sorghum and non-crop areas Date of registration: 28 March 2017 Product registration no.: 83003 Label approval no.: 83003/107292

Application no.: 108536 Product name: Relyon Carpenter 400EC Herbicide Active constituent/s: 400 g/L carfentrazone-ethyl Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use: For improvement in the control of marshmallow and certain other broadleaf weeds Date of registration: 28 March 2017 Product registration no.: 83519 Label approval no.: 83519/108536

Application no.: 107591 Product name: Coogee Chemicals Sodium Hypochlorite Solution Active constituent/s: 125 g/L available chlorine (Cl) present as sodium hypochlorite Applicant name: Coogee Chemicals Pty Ltd Applicant ACN: 008 747 500 Summary of use: For control of algae and bacteria in swimming pools Date of registration: 28 March 2017 Product registration no.: 83126 Label approval no.: 83126/107591

Application no.: 107673 Product name: Barmac Paraquat/Diquat 250 Herbicide Active constituent/s: 135 g/L paraquat present as paraquat dichloride

115 g/L diquat present as diquat dibromide Applicant name: Amgrow Pty Ltd Applicant ACN: 100 684 786 Summary of use: For the control of a wide range of grasses and broadleaf weeds Date of registration: 28 March 2017 Product registration no.: 83169 Label approval no.: 83169/107673

Application no.: 107862 Product name: EzyCrop S-Metolachlor 960 EC Herbicide Active constituent/s: 960 g/L s-metolachlor Applicant name: Ezycrop Pty Ltd Applicant ACN: 156 476 827 Summary of use: For the control of certain annual grasses and broadleaf weeds in certain crops Date of registration: 28 March 2017 Product registration no.: 83262 Label approval no.: 83262/107862



Application no.: 108319 Product name: TrueCrop Glyphosate 450SL Herbicide Active constituent/s: 450 g/L glyphosate present as the isopropylamine salt Applicant name: Truecrop Pty Ltd Applicant ACN: 605 343 824 Summary of use: For use as a non-selective herbicide that will kill most emerged weeds and plants Date of registration: 28 March 2017 Product registration no.: 83465 Label approval no.: 83465/108319

Application no.: 108316 Product name: Bison Herbicide Coated Fertiliser Active constituent/s: 10 g/kg oxadiazon Applicant name: Crop Culture Pty Ltd Applicant ACN: 142 860 473 Summary of use: For use in pre-emergent control of summer grass, crab grass and winter grass in turf

and for nutrient delivery to turf Date of registration: 28 March 2017 Product registration no.: 83464 Label approval no.: 83464/108316

2. VARIATIONS OF REGISTRATION

Application no.: 106823 Product name: ACTA 1080 Dried Meat Wild Dog Bait Active constituent/s: 150 mg/kg sodium fluoroacetate (1080), 6 mg sodium fluoroacetate (1080) per bait Applicant name: Animal Control Technologies (Australia) Pty Ltd Applicant ACN: 137 868 449 Summary of variation: To extend use to all States Date of variation: 9 March 2017 Product registration no.: 80919 Label approval no.: 80919/106823

Application no.: 106824 Product name: ACTA 1080 Dried Meat Fox Bait Active constituent/s: 80 mg/kg sodium fluoroacetate (1080), 3 mg sodium fluoroacetate (1080) per bait Applicant name: Animal Control Technologies (Australia) Pty Ltd Applicant ACN: 137 868 449 Summary of variation: To extend use to all States Date of variation: 10 March 2017 Product registration no.: 80924 Label approval no.: 80924/106824

Application no.: 107857 Product name: Nufarm Tazer Xpert Fungicide Active constituent/s: 80 g/L azoxystrobin, 31.25 g/L epoxiconazole Applicant name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of variation: To vary existing application rates and inclusion of new diseases in wheat and oats Date of variation: 16 March 2017 Product registration no.: 69803 Label approval no.: 69803/107857



Application no.: 101905 Product name: Gem Fungicide Active constituent/s: 500 g/L fluazinam Applicant name: Adama Australia Pty Limited Applicant ACN: 050 328 973 Summary of variation: To extend to use in grapevines for the control of eutypa lata on pruning wounds Date of variation: 23 March 2017 Product registration no.: 61450 Label approval no.: 61450/101905



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 EXISTING ACTIVE CONSTITUENTS

Application no.: 105128 Product name: Neove Imidacloprid Spot On For Cats Over 4 kg Active constituent/s: 100 g/L imidacloprid Applicant name: Neove Pharma Australia Pty Limited Applicant ACN: 140 367 442 Summary of use: For use in the treatment and prevention of fleas on cats over 4 kg Date of registration: 1 March 2017 Product registration no.: 82172 Label approval no.: 82172/105128

Application no.: 105127 Product name: Neove Imidacloprid Spot On For Kittens & Small Cats Up To 4 kg Active constituent/s: 100 g/L imidacloprid Applicant name: Neove Pharma Australia Pty Limited Applicant ACN: 140 367 442 Summary of use: For use in the treatment and prevention of fleas on kittens and small cats up to 4 kg Date of registration: 1 March 2017 Product registration no.: 82171 Label approval no.: 82171/105127

Application no.: 105126 Product name: Neove Imidacloprid Spot On For Puppies & Small Dogs Up To 4 kg Active constituent/s: 100 g/L imidacloprid Applicant name: Neove Pharma Australia Pty Limited Applicant ACN: 140 367 442 Summary of use: For use in the treatment and prevention of fleas, and control of lice on puppies and

small dogs up to 4 kg Date of registration: 10 March 2017 Product registration no.: 82170 Label approval no.: 82170/105126

Application no.: 105125 Product name: Neove Imidacloprid Spot On For Dogs 4–10 kg Active constituent/s: 100 g/L imidacloprid Applicant name: Neove Pharma Australia Pty Limited Applicant ACN: 140 367 442 Summary of use: For use in the treatment and prevention of fleas, and control of lice on 4–10 kg dogs Date of registration: 10 March 2017 Product registration no.: 82169 Label approval no.: 82169/105125



Application no.: 105124 Product name: Neove Imidacloprid Spot On For Dogs 10–25 kg Active constituent/s: 100 g/L imidacloprid Applicant name: Neove Pharma Australia Pty Limited Applicant ACN: 140 367 442 Summary of use: For use in the treatment and prevention of fleas, and control of lice on 10–25 kg dogs Date of registration: 10 March 2017 Product registration no.: 82168 Label approval no.: 82168/105124

Application no.: 105123 Product name: Neove Imidacloprid Spot On For Dogs Over 25 kg Active constituent/s: 100 g/L imidacloprid Applicant name: Neove Pharma Australia Pty Limited Applicant ACN: 140 367 442 Summary of use: For use in the treatment and prevention of fleas, and control of lice on dogs over 25 kg Date of registration: 10 March 2017 Product registration no.: 82167 Label approval no.: 82167/105123

Application no.: 107918 Product name: Monthly Spot-On Flea Treatment for Small Dogs—Vet Series Active constituent/s: 195 g/L indoxacarb (s-isomer) Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For the control of existing fleas infestations and new flea infestations as well as flea

allergy dermatitis on small dogs 6.6 kg and up to 10 kg Date of registration: 20 March 2017 Product registration no.: 83296 Label approval no.: 83296/107918

Application no.: 107917 Product name: Monthly Spot-On Flea Treatment for Medium Dogs—Vet Series Active constituent/s: 195 g/L indoxacarb (s-isomer) Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For the control of existing fleas infestations and new flea infestations as well as flea

allergy dermatitis on medium dogs over 10 kg and up to 20 kg Date of registration: 20 March 2017 Product registration no.: 83295 Label approval no.: 83295/107917

Application no.: 107913 Product name: Monthly Spot-On Flea Treatment for Large Dogs—Vet Series Active constituent/s: 195 g/L indoxacarb (s-isomer) Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For the control of existing fleas infestations and new flea infestations as well as flea

allergy dermatitis on large dogs over 20 kg and up to 40 kg Date of registration: 20 March 2017 Product registration no.: 83294 Label approval no.: 83294/107913



Application no.: 107909 Product name: Monthly Spot-On Flea Treatment for Cats Over 4 kg—Vet Series Active constituent/s: 195 g/L indoxacarb (s-isomer) Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For the control of existing fleas infestations and new flea infestations as well as flea

allergy dermatitis on cats over 4 kg Date of registration: 20 March 2017 Product registration no.: 83291 Label approval no.: 83291/107909

Application no.: 107908 Product name: Monthly Spot-On Flea Treatment for Very Large Dogs—Vet Series Active constituent/s: 195 g/L indoxacarb (s-isomer) Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For the control of existing fleas infestations and new flea infestations as well as flea

allergy dermatitis on very large dogs over 40 kg and up to 60 kg Date of registration: 20 March 2017 Product registration no.: 83290 Label approval no.: 83290/107908

Application no.: 104469 Product name: Cardisure Flavoured 1.25 mg Tablets For Dogs Active constituent/s: 1.25 mg/Tb pimobendan Applicant name: Eurovet Animal Health BV Applicant ACN: NA Summary of use: For the treatment of canine congestive heart failure originating from dilated

cardiomyopathy or valvular insufficiency Date of registration: 22 March 2017 Product registration no.: 81948 Label approval no.: 81948/104469

Application no.: 107907 Product name: Monthly Spot-On Flea Treatment for Very Small Dogs—Vet Series Active constituent/s: 195 g/L indoxacarb (s-isomer) Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For the control of existing fleas infestations and new flea infestations as well as flea

allergy dermatitis on very small dogs 1.5 kg and up to 6.5 kg Date of registration: 22 March 2017 Product registration no.: 83289 Label approval no.: 83289/107907

Application no.: 104463 Product name: Cardisure Flavoured 5mg Tablets For Dogs Active constituent/s: 5 mg/Tb pimobendan Applicant name: Eurovet Animal Health BV Applicant ACN: N/A Summary of use: For the treatment of canine congestive heart failure originating from dilated

cardiomyopathy or valvular insufficiency in dogs Date of registration: 22 March 2017 Product registration no.: 81942 Label approval no.: 81942/104463



Application no.: 104465 Product name: Cardisure Flavoured 10 mg Tablets For Dogs Active constituent/s: 10 mg/Tb pimobendan Applicant name: Eurovet Animal Health Bv Applicant ACN: N/A Summary of use: For the treatment of canine congestive heart failure originating from dilated

cardiomyopathy or valvular insufficiency Date of registration: 22 March 2017 Product registration no.: 81944 Label approval no.: 81944/104465

Application no.: 104467 Product name: Cardisure Flavoured 2.5 mg Tablets For Dogs Active constituent/s: 2.5 mg/Tb pimobendan Applicant name: Eurovet Animal Health Bv Applicant ACN: NA Summary of use: For the treatment of canine congestive heart failure originating from dilated cardiomyopathy

or valvular insufficiency Date of registration: 22 March 2017 Product registration no.: 81946 Label approval no.: 81946/104467

Application no.: 102864 Product name: Fostera PCV MH Active constituent/s: 1 RP mycoplasma hyopneumoniae vaccine, 1 RP cpcv 1–2 inactivated suspension Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use: For the prevention of porcine circovirus type 2 (PCV2) viraemia, virus shedding,

lymphoid depletion, histiocytic replacement and colonization of lymphoid tissue caused by PCV2 and in the control of PCV associated disease (PCVAD). Also as an aid in reducing enzootic pneumonia caused by mycoplasma hyopneumoniae


Application no.: 106538 Product name: Gastropell Forte Oral Paste for Horses Active constituent/s: 100 mg/ml omeprazole Applicant name: Randlab Australia Pty Ltd Applicant ACN: 114 948 837 Summary of use: For the treatment and prevention of recurrence of gastric ulcers in high performance

racehorses Date of registration: 22 March 2017 Product registration no.: 82722 Label approval no.: 82722/106538



Application no.: 107910 Product name: Monthly Spot-On Flea Treatment for Kittens & Cats up to 4kg—Vet Series Active constituent/s: 195 g/L indoxacarb (s-isomer) Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For the control of existing fleas infestations and new flea infestations as well as flea

allergy dermatitis on kittens and cats up to 4 kg Date of registration: 24 March 2017 Product registration no.: 83293 Label approval no.: 83293/107910

2. VARIATIONS OF REGISTRATION

Application no.: 108907 Product name: CCD OTC 10 Soluble Powder Active constituent/s: 10 g/kg Oxytetracycline Hydrochloride Applicant name: CCD Animal Health Pty Ltd Applicant ACN: 151 737 950 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘TETRACIN 10 SOLUBLE POWDER’ to ‘CCD OTC 10 SOLUBLE POWDER’ Date of variation: 12 December 2016 Product registration no.: 41943 Label approval no.: 41943/108907

Application no.: 109477 Product name: Uddersan Iodophor Teat Sanitiser Active constituent/s: 20 g/L iodine, 10 g/L ethoxylated lanolin, 45 g/L sorbitol, 45 g/L propylene glycol Applicant name: Tasman Chemicals Pty Limited Applicant ACN: 005 072 659 Summary of variation: To approve a new label for the product with a label name of ‘TEAT ARMOUR IODOPHOR

TEAT SANITISER’ Date of variation: 17 March 2017 Product registration no.: 38467 Label approval no.: 38467/109477

Application no.: 109478 Product name: Uddersan Ready-To-Use Iodophor Teat Sanitiser Active constituent/s: 5 g/L available iodine Applicant name: Tasman Chemicals Pty Limited Applicant ACN: 005 072 659 Summary of variation: To approve a new label for the product with a label name of ‘READY ARMOUR READY-

TO-USE IODOPHOR TEAT SANITISER’ Date of variation: 17 March 2017 Product registration no.: 54611 Label approval no.: 54611/109478



Application no.: 108394 Product name: Exelpet Vet Series Monthly Flea, Intestinal & Heartworm Treatment for Dogs 4–10 kg Active constituent/s: 100 g/L imidacloprid, 25 g/L moxidectin Applicant name: Bayer Australia Ltd (Animal health) Applicant ACN: 000 138 714 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘VETS CHOICE FOR DOGS 4–10 KG, FLEAS, HEARTWORM AND WORMS’ to ‘EXELPET VET SERIES MONTHLY FLEA, INTESTINAL & HEARTWORM TREATMENT FOR DOGS 4–10 KG’

Date of variation: 17 March 2017 Product registration no.: 80437 Label approval no.: 80437/108394



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 CONSTITUENT

Application no.: 107265 Active constituent/s: Pyraclostrobin Applicant name: Colin Campbell (Chemicals) Pty Ltd Applicant ACN: 000 045 590 Summary of use: Approval of pyraclostrobin for use in agricultural chemical products Date of approval: 24 March 2017 Approval no.: 82987

Application no.: 107158 Active constituent/s: Epoxiconazole Applicant name: Profeng Australia Pty Ltd Applicant ACN: 156 055 533 Summary of use: Approval of epoxiconazole for use in agricultural chemical products Date of approval: 24 March 2017 Approval no.: 82937

Approved Active Constituents


Approved Active Constituents—Section 14A

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, s14A, 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.


Application no.: 108993 Active constituent/s: Pyrantel Embonate Applicant name: Bob Martin (Australia) Pty Ltd Applicant ACN: 062 627 883 Summary of use: For use in veterinary chemical products Date of approval: 22 February 2017 Approval no.: 83800

Application no.: 107859 Active constituent/s: Clotrimazole Applicant name: Vetoquinol Australia Pty Ltd Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 22 February 2017 Approval no.: 83260

Application no.: 109159 Active constituent/s: Benazepril Hydrochloride Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 22 February 2017 Approval no.: 83879

Application no.: 107237 Active constituent/s: Propetamphos Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of use: For use in veterinary chemical products Date of approval: 23 February 2017 Approval no.: 82970

Application no.: 109214 Active constituent/s: Cloprostenol Sodium Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 24 February 2017 Approval no.: 83900



Application no.: 109216 Active constituent/s: Closantel Base Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 24 February 2017 Approval no.: 83902

Application no.: 108744 Active constituent/s: Selenium Sodium EDTA Applicant name: Merial Australia Pty Ltd Applicant ACN: 071 187 285 Summary of use: For use in veterinary chemical products Date of approval: 24 February 2017 Approval no.: 83627

Application no.: 109553 Active constituent/s: Ivermectin Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use: For use in veterinary chemical products Date of approval: 27 February 2017 Approval no.: 84041

Application no.: 107216 Active constituent/s: Milbemycin Oxime Applicant name: Neove Pharma Australia Pty Limited Applicant ACN: 140 367 442 Summary of use: For use in veterinary chemical products Date of approval: 27 February 2017 Approval no.: 82961

Application no.: 109018 Active constituent/s: Dicyclanil Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For use in veterinary chemical products Date of approval: 27 February 2017 Approval no.: 83814

Application no.: 108523 Active constituent/s: Permethrin Applicant name: Merial Australia Pty Ltd Applicant ACN: 071 187 285 Summary of use: For use in veterinary chemical products Date of approval: 27 February 2017 Approval no.: 83510



Application no.: 109220 Active constituent/s: Levamisole Hydrochloride Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 27 February 2017 Approval no.: 83906

Application no.: 109755 Active constituent/s: Tilmicosin Phosphate Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of use: For use in veterinary chemical products Date of approval: 8 March 2017 Approval no.: 84131

Application no.: 107104 Active constituent/s: Levamisole Applicant name: Chemvet Australia Pty Ltd Applicant ACN: 138 711 289 Summary of use: For use in veterinary chemical products Date of approval: 16 March 2017 Approval no.: 82913

Application no.: 107535 Active constituent/s: Phenylbutazone Applicant name: Ranvet Pty Limited Applicant ACN: 001 606 033 Summary of use: For use in veterinary chemical products Date of approval: 16 March 2017 Approval no.: 83103

Application no.: 107597 Active constituent/s: Amitraz Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For use in veterinary chemical products Date of approval: 16 March 2017 Approval no.: 83129

Application no.: 109222 Active constituent/s: Oxantel Embonate Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 21 March 2017 Approval no.: 83908



Application no.: 109448 Active constituent/s: Tylosin Tartrate Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use: For use in veterinary chemical products Date of approval: 21 March 2017 Approval no.: 83982

Application no.: 107683 Active constituent/s: Ceftiofur Hydrochloride Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use: For use in veterinary chemical products Date of approval: 22 March 2017 Approval no.: 83178

Application no.: 109507 Active constituent/s: Morantel Tartrate Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 22 March 2017 Approval no.: 84013

Application no.: 109519 Active constituent/s: Levamisole Hydrochloride Applicant name: The Hunter River Company Pty Limited Applicant ACN: 133 798 615 Summary of use: For use in veterinary chemical products Date of approval: 22 March 2017 Approval no.: 84023

Application no.: 109627 Active constituent/s: Trenbolone Acetate Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd Applicant ACN: 000 233 992 Summary of use: For use in veterinary chemical products Date of approval: 22 March 2017 Approval no.: 84070

Application no.: 108199 Active constituent/s: Triclosan Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products Date of approval: 23 March 2017 Approval no.: 83406



Application no.: 108285 Active constituent/s: Dinitolmide Applicant name: CCD Animal Health Pty Ltd Applicant ACN: 151 737 950 Summary of use: For use in veterinary chemical products Date of approval: 23 March 2017 Approval no.: 83440

Application no.: 109221 Active constituent/s: Zinc Oxide Applicant name: Robin Pharmaceuticals Limited Applicant ACN: N/A Summary of use: For use in veterinary chemical products Date of approval: 23 March 2017 Approval no.: 83907

Application no.: 109107 Active constituent/s: Cetrimide Applicant name: Robin Pharmaceuticals Limited Applicant ACN: N/A Summary of use: For use in veterinary chemical products Date of approval: 23 March 2017 Approval no.: 83867

Application no.: 107528 Active constituent/s: Ranitidine Hydrochloride Applicant name: Ranvet Pty Limited Applicant ACN: 001 606 033 Summary of use: For use in veterinary chemical products Date of approval: 28 March 2017 Approval no.: 83100

Application no.: 107511 Active constituent/s: Pergolide Mesylate Applicant name: Ranvet Pty Limited Applicant ACN: 001 606 033 Summary of use: For use in veterinary chemical products Date of approval: 28 March 2017 Approval no.: 83093

Application no.: 107515 Active constituent/s: Nitrofurazone Applicant name: Ranvet Pty Limited Applicant ACN: 001 606 033 Summary of use: For use in veterinary chemical products Date of approval: 28 March 2017 Approval no.: 83094



Application no.: 109508 Active constituent/s: Pyridoxine Hydrochloride Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 28 March 2017 Approval no.: 84014

Application no.: 109243 Active constituent/s: Gonadorelin Acetate Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 83917

Application no.: 109245 Active constituent/s: Dexamethasone Sodium Phosphate Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 83918

Application no.: 107387 Active constituent/s: Omeprazole 20% Applicant name: Nauts Equine Applicant ACN: 612 589 170 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 83049

Application no.: 109391 Active constituent/s: Cefalexin Monohydrate Applicant name: Bocko P/L & Flexsky P/L (in Partnership) T/A Pharmachem Applicant ACN: 078 722 371 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 83976

Application no.: 109393 Active constituent/s: Permethrin Applicant name: Bocko P/L & Flexsky P/L (in Partnership) T/A Pharmachem Applicant ACN: 078 722 371 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 83977



Application no.: 109328 Active constituent/s: Mometasone Furoate Monohydrate Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 83954

Application no.: 109495 Active constituent/s: Acepromazine Maleate Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 84003

Application no.: 109499 Active constituent/s: Adenosine Triphosphate Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 84005

Application no.: 109500 Active constituent/s: Copper Indomethacin Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 84006

Application no.: 109510 Active constituent/s: Riboflavin 5' Phosphate Sodium Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 84016

Application no.: 109686 Active constituent/s: Stilboestrol Applicant name: Apex Laboratories Pty Ltd Applicant ACN: 614 716 700 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 84092



Application no.: 109688 Active constituent/s: Neomycin Sulfate Applicant name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of use: For use in veterinary chemical products Date of approval: 29 March 2017 Approval no.: 84094

Application no.: 107865 Active constituent/s: Calcium as Calcium Gluconate Applicant name: Vetoquinol Australia Pty Ltd Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 83265

Application no.: 109509 Active constituent/s: Sodium Cacodylate Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 84015

Application no.: 109641 Active constituent/s: Chloramphenicol Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 84073

Application no.: 109640 Active constituent/s: Nandrolone Laurate Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 84072

Application no.: 109230 Active constituent/s: Pyrantel Embonate Applicant name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 83913



Application no.: 109591 Active constituent/s: Amoxicillin Trihydrate Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 84057

Application no.: 109520 Active constituent/s: Sodium Phosphate Tribasic Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 84024

Application no.: 109563 Active constituent/s: Virginiamycin Applicant name: Phibro Animal Health Pty Limited Applicant ACN: 093 869 991 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 84042

Application no.: 109534 Active constituent/s: Sodium Selenite Applicant name: Agrimin Ltd Applicant ACN: N/A Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 84031

Application no.: 109530 Active constituent/s: Isopropyl Alcohol Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 84029

Application no.: 109505 Active constituent/s: Hyaluronic Acid Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 84011

Approved Active Constituent—Section 14A


Application no.: 109506 Active constituent/s: L-Lysine Hydrochloride Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 84012

Application no.: 109389 Active constituent/s: Prednisolone Acetate Applicant name: Bocko P/L & Flexsky P/L (in Partnership) T/A Pharmachem Applicant ACN: 078 722 371 Summary of use: For use in veterinary chemical products Date of approval: 30 March 2017 Approval no.: 83974

Approved Active Constituent—Section 14A


Approved Active Constituents—Section 14

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, s14, 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.


Application no.: 108605 Active constituent/s: Porcine Circovirus Type 1–Type 2 Chimera—Inactivated Antigen Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use: For use in veterinary chemical products Date of approval: 8 March 2017 Approval no.: 83556

Application no.: 108664 Active constituent/s: Mycoplasma Hyopneumoniae - Inactivated Antigen Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use: For use in veterinary chemical products Date of approval: 8 March 2017 Approval no.: 83587

Application no.: 108666 Active constituent/s: Clostridium Chauvoei AWC437 Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 8 March 2017 Approval no.: 83589

2. VARIATIONS OF ACTIVE CONSTITUENT

Application no.: 107505 Active constituent/s: Lead Acetate Applicant name: Ranvet Pty Limited Applicant ACN: 001 606 033 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 27 February 2017 Approval no.: 55709

Application no.: 106745 Active constituent/s: Selamectin Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 10 March 2017 Approval no.: 56261



Application no.: 108796 Active constituent/s: Doramectin Applicant name: Merial Australia Pty Ltd Applicant ACN: 071 187 285 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 14 March 2017 Approval no.: 82295

Application no.: 109891 Active constituent/s: Eprinomectin Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 16 March 2017 Approval no.: 82862

Application no.: 109940 Active constituent/s: Milbemycin Oxime Applicant name: Merial Australia Pty Ltd Applicant ACN: 071 187 285 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 21 March 2017 Approval no.: 82206

Application no.: 107785 Active constituent/s: Cefovecin Sodium Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 22 March 2017 Approval no.: 60584

Application no.: 108275 Active constituent/s: Medetomidine Hydrochloride Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 23 March 2017 Approval no.: 81979

Application no.: 108368 Active constituent/s: Spironolactone Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 23 March 2017 Approval no.: 82343



Application no.: 109663 Active constituent/s: Ambroxol Hydrochloride Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 30 March 2017 Approval no.: 54688



New Chemical Product Talinor Herbicide Containing Bicyclopyrone

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for registration of a new product containing a new active constituent. The product is Talinor Herbicide.

PARTICULARS OF THE APPLICATION

Proposed product name(s): Talinor Herbicide

Applicant company: Syngenta Australia Pty Ltd

Name of active constituent: Bicyclopyrone

Signal heading: Schedule 5

Summary of proposed use: For the post-emergent control of a range of broadleaf weeds in wheat and barley

Pack sizes: 5–1000 Litres

Withholding period: Harvest: Not required when used as directed

Grazing: Do not graze or cut for stock feed for 6 weeks after application

SUMMARY OF THE APVMA’S EVALUATION OF TALINOR HERBICIDE IN ACCORDANCE WITH THE REQUIREMENTS OF SECTION 14(1)(C) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (THE ‘AGVET CODE’), SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994

1. The APVMA has evaluated the application and in its assessment in relation to whether the safety criteria have been met in accordance with the definition set out in section 5A of the Agvet Code, and proposes to determine that:

(i) The APVMA is satisfied that the proposed use of Talinor Herbicide would not be an undue hazard to the safety of people exposed to it during its handling and use.

(ii) The APVMA is satisfied that the proposed use of Talinor Herbicide will not be an undue hazard to the safety of people using anything containing its residues.

(iii) The APVMA is satisfied that the proposed use of Talinor Herbicide containing the active constituent bicyclopyrone is not likely to be harmful to human beings if used according to the product label directions.

(iv) The APVMA is satisfied that the proposed use of Talinor Herbicide is not likely to have an unintended effect that is harmful to animals, plants or the environment if used according to the product label directions.

2. The APVMA has evaluated the application and in its assessment in relation to whether the efficacy criteria have been met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:

(i) In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials supporting the efficacy of the product adequately demonstrate that if used according to the product label directions, the product is effective for its proposed uses.



3. The APVMA has evaluated the application and in its assessment in relation to whether the trade criteria have been met in accordance with the definition set out in section 5C of the Agvet Code, and proposes to determine that:

(i) The APVMA is considering whether the proposed use of Talinor Herbicide would not adversely affect trade between Australia and places outside Australia.

FURTHER INFORMATION

A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website ‘Public Consultation’ page, www.apvma.gov.au/news-and-publications/public-consultations or by contacting the APVMA unit listed below.

MAKING A SUBMISSION

In accordance with section13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether Talinor Herbicide should be registered. Submissions should relate only to matters that are required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have been met. Submissions should state the grounds on which they are based.

Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and in determining appropriate conditions of registration and product labelling.

When making a submission please include:

• contact name • company or group name (if relevant) • email or postal address • the date you made the submission.

All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially.

Written submissions should be addressed in writing to:

Case Management and Administration Unit Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4701 Fax: +61 2 6210 4721 Email: [email protected]


http://www.apvma.gov.au/news-and-publications/public-consultations

mailto:[email protected]

apvma gazette no. 7, 4 april 2017. apvma 7, tuesday, 4 april 2017 published by the australian...

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