apvma gazette no. 17, 27 august 2013

No. APVMA 17, Tuesday, 27 August 2013

Published by The Australian Pesticides & Veterinary Medicines Authority

AGRICULTURAL AND

VETERINARY CHEMICALS

The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995.

The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be

published in the Gazette containing details of the registration of agricultural and veterinary chemical products

and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code

and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet

Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.

ISSN 1837 - 7629

Commonwealth of Australia Gazette No. APVMA 17, Tuesday, 27 August 2013 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2013

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any

process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and

inquiries concerning reproduction and rights should be addressed to:

The Manager, Public Affairs

The Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

Kingston ACT 2604

Email: [email protected]

Website: www.apvma.gov.au

GENERAL INFORMATION

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

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

by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material

issued by the APVMA.

Pursuant to section 53(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications

made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

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

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

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


CONTENTS

Notice of Registrations 4 Agricultural Chemical Products .............................................................................................................................................. 4 Veterinary Chemical Products .............................................................................................................................................. 17

Notice – New Agricultural Active Constituent 21 Inactivated Porcine Circovirus Type 1–Type 2 Chimera [in the product: Relsure PCV] ....................................................... 21

OTHER NOTICES 25 Cancellation of selected Approvals and Registrations Related to 2,4-D High Volatile Esters (HVE) .................................... 25 Cancellation of Label Approval at the Request of the Registrant ......................................................................................... 33 Exemption from Offence Provisions ..................................................................................................................................... 35 Exemption from Offence Provisions ..................................................................................................................................... 36 Addendum to the Record of Approved Active Constituents .................................................................................................. 37 Application Summaries ......................................................................................................................................................... 39


Notice of Registrations – Agricultural Chemical Products

NOTICE OF REGISTRATIONS

Agricultural Chemical Products

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals

Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following

products, with effect from the dates shown.

1. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: Rainbow Imazapic 240 Herbicide

Active Constituent/s: 240 g/L imazapic present as the ammonium salt

Applicant Name: Shandong Rainbow International Co., Ltd.

Applicant ACN: N/A

Summary of Use: For the pre-emergence control of certain annual grass and broadleaf weeds in fallow situations, sugarcane and peanuts and early post-emergence control of certain annual grass and broadleaf weeds in peanuts and sugarcane

Date of Registration: 6 August 2013

Label Approval No: 69076/59874

Product Name: Andromeda Glyphosate 450 Herbicide

Active Constituent/s: 450 g/L glyphosate present as the isopropylamine salt

Applicant Name: PT. Sari Kresna Kimia

Applicant ACN: N/A

Summary of Use: For non-selective control of many annual and perennial weeds and grasses in certain situations



Product Name: Banjo Spray Adjuvant

Active Constituent/s: 725 g/L methyl esters of canola oil

Applicant Name: Nufarm Australia Limited

Applicant ACN: 004 377 780

Summary of Use: For use as an adjuvant with selected herbicides



Product Name: Sinochem Rivet 125 SC Fungicide

Active Constituent/s: 125 g/L epoxiconazole

Applicant Name: Sinochem Agro Co., Ltd

Applicant ACN: N/A

Summary of Use: For the control of fungal diseases of wheat and barley



Product Name: Searles Ecofend Natural Solutions Fruit & Garden Insect & Scale Spray

Active Constituent/s: 830 g/L paraffinic oil

Applicant Name: J C & A T Searle Pty Ltd


Summary of Use: For the control of citrus leafminer, insects and scale on fruit trees, vegetables and ornamentals





Product Name: Regular Roundup Ready To Use Weedkiller

Active Constituent/s: 7.2 g/L glyphosate (present as the isopropylamine salt), 21 g/L nonanoic acid.

Applicant Name: Monsanto Australia Limited


Summary of Use: For control of various annual and perennial weeds in home garden situations



Product Name: Simplex 500 SC Herbicide

Active Constituent/s: 500 g/L simazine

Applicant Name: Amgrow Pty Ltd


Summary of Use: For the control of annual grasses and broadleaf weeds in orchards, vineyards, chickpeas, faba beans, lupins, non-crop areas and other crops for use in triazine tolerant canola



Product Name: Voliam Flexi Insecticide

Active Constituent/s: 200 g/kg chlorantraniliprole, 200 g/kg thiamethoxam

Applicant Name: Syngenta Australia Pty Ltd


Summary of Use: For the control of Lepidoptera pests and aphids and suppression or mirids and jassids in cotton



Product Name: EzyCrop Chlorthal 750 WG Herbicide

Active Constituent/s: 750 g/kg chlorthal-dimethyl

Applicant Name: EzyCrop Pty Ltd


Summary of Use: For the pre-emergence weed control in certain vegetable crops including onions, beans, cabbages, cauliflowers, potatoes, carrots and for weed control in strawberries, cotton, lucerne, perennial grass crops, lawns and ornamentals



Product Name: Stomp Aqua Herbicide

Active Constituent/s: 455 g/L pendimethalin

Applicant Name: BASF Australia Ltd.


Summary of Use: For the control of annual ryegrass and wireweed in wheat, barley, peas and annual grasses and certain broadleaf weeds in various crops



Product Name: Agro Burner 250 Herbicide

Active Constituent/s: 115 g/L diquat present as diquat dibromide, 135 g/L paraquat present as paraquat dichloride

Applicant Name: Agrogill Chemicals Pty Ltd


Summary of Use: For the control of a wide range of grasses and broadleaf weeds in various situations





Product Name: Alsystin 480 SC Larvicide

Active Constituent/s: 480 g/L triflumuron

Applicant Name: Bayer Cropscience Pty Ltd


Summary of Use: For the control of sciarid flies on mushrooms



Product Name: Protim Optimum Concentrate Timber Preservative

Active Constituent/s: 121 g/L permethrin, 177 g/L propiconazole, 177 g/L tebuconazole

Applicant Name: Osmose Australia Pty Ltd


Summary of Use: For the protection of softwood and hardwood timber to be used for Hazard Level HS (outside, above ground) situations against fungal decay and timber insects, including lyctids, borers and termites



Product Name: IcOn Phite 600 Systemic Fungicide

Active Constituent/s: 600 g/L phosphorous (phosphonic) acid present as mono & di potassium phosphite

Applicant Name: Sonic Essentials Pty Ltd


Summary of Use: For use against Phytophthora diseases and downy mildew in various situations



Product Name: FMC Chlorothalinil 720 Fungicide

Active Constituent/s: 720 g/L chlorothalonil

Applicant Name: FMC Australasia Pty Ltd


Summary of Use: For the control of fungal diseases on almonds, bananas, cucurbits, grapes, ornamentals, peanuts, stone fruit, tobacco and other vegetables



Product Name: Amgrow Patrol Professional Termiticide and Insecticide

Active Constituent/s: 100 g/L bifenthrin

Applicant Name: Amgrow Pty Ltd


Summary of Use: For the control of termites and a range of other urban pests, and for the control of various insects and mite pests in a variety of crops



Product Name: Genfarm S-Metolachlor 960 Herbicide

Active Constituent/s: 960 g/L S-metolachlor

Applicant Name: Landmark Operations Limited


Summary of Use: For the control of annual grasses and broadleaf weeds in certain crops





Product Name: Rancona Dimension Seed Treatment

Active Constituent/s: 25 g/L ipconazole, 20 g/L metalaxyl

Applicant Name: Chemtura Australia Pty Ltd


Summary of Use: For the control or suppression of various seedling diseases in wheat, barley and oats



Product Name: FallowBoss Tordon Herbicide

Active Constituent/s: 7.5 g/L aminopyralid present as triisopropanolamine salt, 75 g/L picloram present as the triisopropanolamine salt, 300 g/L 2,4-D present as the triisopropanolamine salt

Applicant Name: Dow AgroSciences Australia Limited


Summary of Use: For control of a range of annual and perennial broadleaf weeds in cereals and fallow land



Product Name: Anka Atrazine 900 WG Herbicide

Active Constituent/s: 900 g/kg atrazine

Applicant Name: Anka Industries Pty Ltd


Summary of Use: For the control of weeds and grasses in sorghum, maize, sugarcane, TT-canola, lucerne and fallow area maintenance and other situations



Product Name: Chaindrite2 Metered Insect Spray

Active Constituent/s: 60 g/kg piperonyl butoxide, 14 g/kg pyrethrins

Applicant Name: Sherwood Chemicals Australasia Pty Ltd


Summary of Use: For the control of flying and crawling insects



Product Name: Farmalinx 2,4-D 450 SL Herbicide

Active Constituent/s: 450 g/L 2,4-D present as the isopropylamine salt

Applicant Name: Farmalinx Pty Ltd


Summary of Use: For the control of emerged broadleaf weeds prior to sowing crops and pastures in conservation tillage situations and for selective weed control in crops and situations



Product Name: Apparent Triflumuron 480 Larvicide

Active Constituent/s: 480 g/L triflumuron

Applicant Name: Apparent Pty. Ltd.


Summary of Use: For the control of silverfish, immature fleas and cockroaches in indoor and outdoor situations





Product Name: Kenso Agcare Brutus 800 Insecticide

Active Constituent/s: 800 g/kg fipronil

Applicant Name: Kenso Corporation (M) Sdn. Bhd.

Applicant ACN: N/A

Summary of Use: For the control of various insect pests in bananas, brassicas, cotton, wine grapevines, potatoes and sugarcane



Product Name: Apparent Iprodione 500 Fungicide

Active Constituent/s: 500 g/L iprodione



Summary of Use: For the control of certain fungal diseases in various crops and situations



Product Name: Agrochina Atrazine 900 WG Herbicide

Active Constituent/s: 900 g/kg atrazine

Applicant Name: Shanghai Agrochina International Trade Co., Ltd

Applicant ACN: N/A

Summary of Use: For the control of annual grasses and broadleaf weeds in sorghum, maize, sugar cane, TT-canola, lucerne and for fallow area maintenance and other situations



Product Name: Apparent Procymidone 500 Fungicide

Active Constituent/s: 500 g/L procymidone



Summary of Use: For the control of certain fungal diseases on various crops



Product Name: FMC Bromoxynil 200 EC Herbicide

Active Constituent/s: 200 g/L bromoxynil present as the n-octanoyl ester



Summary of Use: For the control of weeds in wheat, oats, barley, cereal rye and triticale (alone or under sown), linseed, clover and lucerne pastures, turf, fallow, non-crop, roadsides and right-of-way



Product Name: Apparent Thidiazuron Cotton Defoliant

Active Constituent/s: 500 g/L thidiazuron



Summary of Use: For the defoliation of cotton prior to harvest





Product Name: Atlas Advanced Insect Bomb

Active Constituent/s: 0.77 g/kg fenoxycarb, 10 g/kg permethrin

Applicant Name: Pascoe's Pty Ltd


Summary of Use: For use against insects in the home



Product Name: Aquahealth Tropical Algaecide

Active Constituent/s: 19 g/L copper present as complex blend of copper salts, 100 g/L benzalkonium chloride

Applicant Name: Waterco Limited


Summary of Use: For the control of blue-green, black and mustard algae in swimming pools



Product Name: Sabakem Imidacloprid 350SC Soil Insecticide

Active Constituent/s: 350 g/L imidacloprid

Applicant Name: Sabakem Pty Ltd


Summary of Use: For the control of greyback and Childers canegrub in sugarcane and silverleaf whitefly in various vegetable crops



Product Name: Apparent Ethephon 720 Growth Regulator

Active Constituent/s: 720 g/L ethephon (an anticholinesterase compound)

Applicant Name: Apparent Pty. Ltd


Summary of Use: For accelerated boll opening, defoliation and pre-conditioning before defoliation of cotton



Product Name: OzCrop Epoxiconazole 125 SC Fungicide

Active Constituent/s: 125 g/L epoxiconazole

Applicant Name: OzCrop Pty. Ltd.


Summary of Use: For the control of leaf rust, stripe rust and Septoria nodorum blotch of wheat and leaf rust of barley



Product Name: Pest Xpert DIY Pest Control Like The Professionals Pro-Spray Outdoor Perimeter Multi-Insect Spray

Active Constituent/s: 1 g/L esfenvalerate

Applicant Name: Sumitomo Chemical Australia Pty. Limited


Summary of Use: For the control of cockroaches, spiders, ants and other insects





Product Name: Farmalinx Commando 200 Herbicide

Active Constituent/s: 200 g/L glufosinate-ammonium



Summary of Use: For non-residual control of certain broadleaf and grass weeds in various situations



Product Name: Sabakem Flutriafol 250SC Fungicide

Active Constituent/s: 250 g/L flutriafol



Summary of Use: For the control of certain fungal diseases on wheat, barley and canola when mixed with fertiliser or applied as a foliar spray



Product Name: Sabakem Fenamiphos 400EC Nematicide And Insecticide

Active Constituent/s: 400 g/L fenamiphos (an anticholinesterase compound)



Summary of Use: For the control of nematodes and sucking insects in crops and turf



Product Name: AquaHealth No More Ducks

Active Constituent/s: 23 g/L alcohol ethoxylate, 100 g/L benzalkonium chloride

Applicant Name: Waterco Limited


Summary of Use: To deter ducks from swimming pools



Product Name: Enviromax Azoxystrobin 250 SC Fungicide

Active Constituent/s: 250 g/L azoxystrobin

Applicant Name: EnviroMax Technologies Pty Ltd


Summary of Use: For use in controlling various diseases of grapes, potatoes, tomatoes, cucurbits, avocados, mangoes, passionfruit and poppies



Product Name: Sterigas 1000 Fumigant

Active Constituent/s: 1000 g/kg ethanedinitrile (EDN)

Applicant Name: BOC Limited


Summary of Use: For the control of insect pests and fungi infesting timber and logs for use by licensed fumigators





Product Name: Sabakem Haloxyfop 520EC Herbicide

Active Constituent/s: 520 g/L haloxyfop present as the haloxyfop-P methyl ester



Summary of Use: For the post-emergent control of a wide range of annual and perennial grass weeds in grain legume and oilseed crops, lucerne, medic and clover pasture and seed crops, forestry, bananas, citrus, grapes, pineapples, pome and stone fruit, pyrethrum, tropical fruit and nut crops



Product Name: FMC Azoxystrobin 250 Fungicide

Active Constituent/s: 250 g/L azoxystrobin



Summary of Use: For the control of various diseases of grapes, potatoes, tomatoes, cucurbits, avocados, mangoes, passionfruit, and poppies



Product Name: OzCrop Picloram/MCPA Herbicide

Active Constituent/s: 26 g/L picloram present as the potassium salt, 420 g/L MCPA present as the potassium salt

Applicant Name: OzCrop Pty. Ltd.


Summary of Use: For the control of climbing buckwheat, common sowthistle, skeleton weed, capeweed, doublegee and other broadleaf weeds in winter cereals and linseed crops



Product Name: Sabakem Fluometuron 900 WG Selective Herbicide

Active Constituent/s: 900 g/kg fluometuron



Summary of Use: For pre and post emergent control of various broadleaf weeds and annual grasses in cotton



Product Name: Melpat Tribasic Liquid Flowable Copper Fungicide

Active Constituent/s: 190 g/L copper (Cu) present as tribasic copper sulphate

Applicant Name: Melpat International Pty Ltd


Summary of Use: For the control of various diseases of fruits, nuts, vegetables and ornamentals



Product Name: Farmalinx Metalaxyl + Copper Oxychloride WP Fungicide

Active Constituent/s: 350 g/kg copper (Cu) present as copper oxychloride, 150 g/kg metalaxyl



Summary of Use: For the control of downy mildew on grapevines, phytophthora trunk canker and root rot of macadamia nuts





Product Name: Sabakem Thidiazuron 500SC Flowable Cotton Defoliant

Active Constituent/s: 500 g/L thidiazuron



Summary of Use: For defoliation of cotton prior to harvest



Product Name: Vitalyse Stabilised Chlorine Rapid Release Granular

Active Constituent/s: 560 g/kg available chlorine (Cl) present as sodium dichloroisocyanurate dihydrate

Applicant Name: International Quadratics Pty Ltd


Summary of Use: For the control of algae and bacteria in outdoor swimming pools



Product Name: AC Chop 500 Insecticide And Termiticide

Active Constituent/s: 500 g/L chlorpyrifos (an anticholinesterase compound)

Applicant Name: Axichem Pty Ltd


Summary of Use: For post-construction management of subterranean termites and other domestic insect pests and certain insect pests in crops and turf



2. VARIATIONS

Product Name: AW Cuft 500 Insecticide And Termiticide

Applicant Name: Agri West Pty Limited


Summary of Variation: To change the product name from ‘AW CHOP 500 INSECTICIDE AND TERMITICIDE’ to ‘AW CUFT 500 INSECTICIDE AND TERMITICIDE’

Date of Variation: 6 August 2013


Product Name: Easyfarm Glyphosate 360 Herbicide

Applicant Name: Easyfarm Pty Ltd


Summary of Variation: To change product name from ‘NOVA AGRO GLYPHOSATE 360 HERBICIDE’ to ‘EASYFARM GLYPHOSATE 360 HERBICIDE’



Product Name: Easyfarm Tri-Allate 500 EC Herbicide



Summary of Variation: To change the product name from ‘NOVA AGRO TRI-ALLATE 500 EC HERBICIDE’ to ‘EASYFARM TRI-ALLATE 500 EC HERBICIDE’





Product Name: Easyfarm Propyzamide 500 SC Herbicide



Summary of Variation: To change the product name from ‘NOVA AGRO PROPYZAMIDE 500 SC HERBICIDE’ to ‘EASYFARM PROPYZAMIDE 500 SC HERBICIDE’



Product Name: Terbyne 750 WG Herbicide

Applicant Name: Sipcam Pacific Australia Pty Ltd


Summary of Variation: To extend the use to include the control of various broadleaf weeds in fallow (prior to planting mung beans, soybeans, wheat, barley and oats)



Product Name: Easyfarm Paraquat-Diquat 250 Herbicide



Summary of Variation: To change the product name from ‘NOVA AGRO PARAQUAT-DIQUAT 250 HERBICIDE’ to ‘EASYFARM PARAQUAT-DIQUAT 250 HERBICIDE’ and to update the Relevant Label Particulars in accordance with the diuron review



Product Name: Roachkill Home Cockroach Gel Bait

Applicant Name: Bayer CropScience Pty Ltd


Summary of Variation: To change the product name from ‘ROACHKILL COCKROACH GEL BAIT’ to ‘ROACHKILL HOME COCKROACH GEL BAIT’ and to update the Relevant Label Particulars



Product Name: Py Insecticide Spray

Applicant Name: C Rudduck Proprietary Limited


Summary of Variation: To change the product name from ‘RUDCHEM PY SPRAY AEROSOL INSECTICIDE’ to ‘PY INSECTICIDE SPRAY’ and to update the Relevant Label Particulars



Product Name: Py Insecticide Mist



Summary of Variation: To change the product name from ‘RUDCHEM PY MIST FORMULATED MIST INSECTICIDE’ to ‘PY INSECTICIDE MIST’ and to update the Relevant Label Particulars



Product Name: Easyfarm Diflufenican 500 Herbicide



Summary of Variation: To change the product name from ‘NOVA AGRO DIFLUFENICAN 500 HERBICIDE’ to ‘EASYFARM DIFLUFENICAN 500 HERBICIDE’





Product Name: Apparent Dingo 500 Insecticide



Summary of Variation: To update the product name from ‘APPARENT CHLORPYRIFOS 500 EC INSECTICIDE’ to ‘APPARENT DINGO 500 INSECTICIDE’; to add additional uses and update the Relevant Label Particulars



Product Name: Easyfarm Cyanazine 900 WG Herbicide



Summary of Variation: To change product name from ‘NOVA AGRO CYANAZINE 900 WG HERBICIDE’ to ‘EASYFARM CYANAZINE 900 WG HERBICIDE’



Product Name: Easyfarm Bensulfuron 600 WG Herbicide



Summary of Variation: To change product name from ‘NOVA AGRO BENSULFURON 600 WG HERBICIDE’ to ‘EASYFARM BENSULFURON 600 WG HERBICIDE’ and update Registered Label Particulars



Product Name: Liberty 200 Herbicide

Applicant Name: Bayer CropScience Pty Ltd


Summary of Variation: To update weeds controlled section to include flax-leaf fleabane



Product Name: PyZap Insecticide



Summary of Variation: To change the product name from ‘PYZAP INSECTICIDE BY C RUDDUCK’ to ‘PYZAP INSECTICIDE’



Product Name: Easyfarm Diclofop-Methyl 375 EC Herbicide



Summary of Variation: To change the product name from ‘NOVA AGRO DICLOFOP-METHYL 375 EC HERBICIDE’ to ‘EASYFARM DICLOFOP-METHYL 375 EC HERBICIDE’



Product Name: Kenso Agcare Kencozeb 750DF Fungicide

Applicant Name: Kenso Corporation (M) Sdn. Bhd.

Applicant ACN: N/A

Summary of Variation: Extension to use to include various fruit, vegetable and field crops and to update the Relevant Label Particulars





Product Name: Easyfarm Clopyralid 300 Herbicide



Summary of Variation: To change the product name from ‘NOVA AGRO CLOPYRALID 300 HERBICIDE’ to ‘EASYFARM CLOPYRALID 300 HERBICIDE’



Product Name: Easyfarm 2,4-D IPA 300 Herbicide



Summary of Variation: To change the product name from ‘NOVA AGRO 2,4-D IPA 300 HERBICIDE’ to ‘EASYFARM 2,4-D IPA 300 HERBICIDE’



Product Name: Easyfarm Glyphosate 700 SG Herbicide



Summary of Variation: To change the product name from ‘NOVA AGRO GLYPHOSATE 700 SG HERBICIDE’ to ‘EASYFARM GLYPHOSATE 700 SG HERBICIDE’



Product Name: Mentor WG Herbicide

Applicant Name: Farmoz Pty Limited


Summary of Variation: To include additional use on sugarcane



Product Name: Py Insecticide Fog



Summary of Variation: To change the product name from ‘RUDCHEM PY FOG FORMULATED FOG INSECTICIDE’ to ‘PY INSECTICIDE FOG’ and to update the Relevant Label Particulars



Product Name: Jubilee Loaded Fungicide

Applicant Name: Farmoz Pty Limited


Summary of Variation: To extend use pattern to include application by foliar spray



Product Name: Aristopet Animal Health Garden Repellent for Dogs and Cats

Applicant Name: Aristopet Pty Ltd


Summary of Variation: To change the product name from ‘ARISTOPET SCRAM! GARDEN GRANULES DOG & CAT REPELLENT’ to ‘ARISTOPET ANIMAL HEALTH GARDEN REPELLENT FOR DOGS AND CATS’ and to add an additional pack size





Product Name: Imtrade Regal 800 WG Insecticide

Applicant Name: Imtrade Australia Pty Ltd


Summary of Variation: To include use in pasture, sorghum and on banana weevil and update the Relevant Label Particulars



Product Name: Easyfarm Lambda 250 CS Insecticide



Summary of Variation: To change the product name from ‘NOVA AGRO LAMBDA 250 CS INSECTICIDE’ to ‘EASYFARM LAMBDA 250 CS INSECTICIDE’



Product Name: Diurex WG Herbicide

Applicant Name: Crop Care Australasia Pty Ltd


Summary of Variation: To extend use to lucerne and update the Relevant Label Particulars




Notice of Registrations – Veterinary Chemical Products

Veterinary Chemical Products

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals

Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following

products, with effect from the dates shown.

1. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS

Product Name: Traumeel ad us Vet

Active Constituent/s: Containing sterile water adjusted to isotonicity (300±15 mOsmols/kg) with sodium chloride 6.182 mg/mL and homeopathic extracts of the following constituents (homeopathic dilution and final concentration ,g/mL in brackets): Aconitum napellus (D4, 0.006), Arnica montana (D4, 0.01), Atropa belladonna (D4,0.01), Bellis perennis (D4, 0.005), Calendula officinalis (D4, 0.01), Chamomilla recutita (D5, 0.001), Echinacea (D4,0.0025), Echinacea purpurea (D4,0.0025), Hypericum perforatum (D4, 0.003), Achillea millefolium (D5,0.001), Symphytum officinale (D8, 0.000001), Calcium sulphides (D6, 0.0001) and Mercury (D8, 0.0000005)

Applicant Name: Gill Group International Pty. Ltd


Summary of Use: For the stimulation of acupuncture points in dogs, cats and horses



2. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: Hill's Prescription Diet Hypo-Treats For Cats

Active Constituent/s: N/A

Applicant Name: Hill's Pet Nutrition Pty Limited


Summary of Use: To register a dry therapeutic pet treat product which is designed to be fed to cats, which are already on a specific veterinary diet, with adverse reactions to food and/or food allergies and cannot tolerate other forms of reward



Product Name: Norofend LV Oxfendazole Drench 90.6 g/L

Active Constituent/s: 90.6 g/L oxfendazole

Applicant Name: Norbrook Laboratories Australia Pty Limited


Summary of Use: For use in the control of benzimidazole-sensitive mature and immature roundworms, lungworms and tapeworms, including inhibited Ostertagia in cattle



Product Name: Flow Sure Cal Milk Fever Injection

Active Constituent/s: 33.3 g/L calcium (as calcium gluconate)

Applicant Name: Abbey Laboratories Pty Ltd


Summary of Use: For use in the treatment of milk fever (hypocalcaemia) in cattle and sheep





Product Name: Hill's Prescription Diet Hypo-Treats for Dogs

Active Constituent/s: N/A

Applicant Name: Hill's Pet Nutrition Pty Limited


Summary of Use: To register a dry therapeutic pet treat product which is designed to be fed to dogs which are already on a specific veterinary diet for dogs with adverse reactions to food and/or food allergies and cannot tolerate other forms of reward



Product Name: Clomav 80 mg Tablets

Active Constituent/s: 80 mg/Tb clomipramine hydrochloride

Applicant Name: Mavlab Pty. Ltd.


Summary of Use: For the treatment of stereotypic behaviours (obsessive compulsive disorders) and as an aid in the treatment of anxiety disorders in dogs weighing 20 kg to 80 kg




Active Constituent/s: 5 mg/Tb clomipramine hydrochloride



Summary of Use: For the treatment of stereotypic behaviours (obsessive compulsive disorders) and as an aid in the treatment of anxiety disorders in dogs weighing 1.25 kg to 5 kg and as an aid in the treatment of urine spraying in desexed and female cats 3 kg or more




Active Constituent/s: 20 mg clomipramine hydrochloride (per tablet)



Summary of Use: For the treatment of stereotypic behaviours (obsessive compulsive disorders) and as an aid in the treatment of anxiety disorders in dogs weighing 5 kg to 20 kg



Product Name: Flow Sure Electrolyte Hartmann's Solution

Active Constituent/s: 0.28 g/L calcium chloride dihydrate, 0.40 g/L potassium chloride, 3.24 g/L sodium lactate, 6 g/L sodium chloride

Applicant Name: Abbey Laboratories Pty Ltd


Summary of Use: For use in the treatment of dehydration and for electrolyte replacement in all species





3. VARIATIONS

Product Name: Revolution for Puppies and Kittens

Applicant Name: Zoetis Australia Pty Ltd


Summary of Variation: To extend use to rabbits for the treatment of sarcoptic mange, ear mites and cheyletiellosis



Product Name: Revolution for Cats



Summary of Variation: To include additional claims: for treatment of biting lice in cats and the treatment of ear mites, sarcoptic mange and cheyletiellosis in rabbits



Product Name: Cerenia 160 mg Tablets For Dogs



Summary of Variation: To add an indication for use in puppies from 8 weeks of age





















Product Name: Synovan Injection for Dogs

Applicant Name: Ceva Animal Health Pty Ltd


Summary of Variation: To extend the in-use shelf life





Product Name: Cerenia Injectable Solution






Product Name: Yours Droolly Tea Tree Antiseptic Ointment for Dogs



Summary of Variation: To change the product name from ‘ARISTOPET TEA TREE OIL ANTISEPTIC OINTMENT’ to ‘YOURS DROOLLY TEA TREE ANTISEPTIC OINTMENT FOR DOGS’



Product Name: Yours Droolly Tea Tree Medicated Skin Lotion for Dogs



Summary of Variation: To change the product name from ‘ARISTOPET TEA TREE OIL MEDICATED SKIN LOTION FOR DOGS’ to ‘YOURS DROOLLY TEA TREE MEDICATED SKIN LOTION FOR DOGS’



Agricultural and Veterinary Chemicals Code Act 1994 21

Notice – New Agricultural Active Constituent – Inactivated Porcine Circovirus Type 1–Type 2 Chimera [in the product: Relsure PCV]

NOTICE – NEW AGRICULTURAL ACTIVE CONSTITUENT

Inactivated Porcine Circovirus Type 1–Type 2 Chimera [in the product: Relsure PCV]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a

new active constituent, Inactivated Porcine Circovirus Type 1-Type 2 Chimera. The APVMA also has before it an

application from the same applicant, for the registration of a new product, RELSURE PCV (‘the product’) containing the

above active constituent.

PARTICULARS OF THE ACTIVE CONSTITUENT

Applicant company: Zoetis Australia Pty Ltd

Manufacturer: Zoetis Inc.

2000 Rockford Road Charles City Iowa USA

Or

601 West Cornhusker Hwy Lincoln Nebraska USA

Name of active constituent: Inactivated Porcine Circovirus Type 1-Type 2 Chimera

Appearance and Identity: As per European Pharmacopoeia

Sterility: As per 9CFR or European Pharmacopoeia

Extraneous agents: As per 9CFR or European Pharmacopeia

Mycoplasma: As per 9CFR or European Pharma As per European Pharmacopeia

Gene technology: Not applicable

Mode of action: Inducing immunological response

PARTICULARS OF THE PRODUCT

Proposed name: RELSURE PCV

Active constituent Inactivated Porcine Circovirus Type 1-Type 2 Chimera

Adjuvant

Sulpholipo-beta-cyclodextrin

Squalane

Name of active constituent: Inactivated Porcine Circovirus Type 1-Type 2 Chimera

Pharmaceutical form: Suspension for injection



Pack sizes: 10 doses in 25 mL HDPE bottle

50 doses in 120 mL HDPE bottle




Target species: Pigs (piglets) from 3 weeks of age

Amounts to be administered and administration route:

2 mL by subcutaneous injection into the neck

Vaccination schedule: One injection from 21 days of age.

Indications for use: For the vaccination of healthy pigs 3 weeks of age or older as an aid in the

prevention of Porcine Circovirus Type 2 (PCV2) viraemia, as an aid in the

prevention of nasal and faecal shedding, as an aid in the reduction of colonisation,

and as an aid in the reduction of lymphoid depletion caused by PCV2 and in the

control of PCV-associated disease.

Side effects: Local tissue reactions in the form of swelling at the injection site may occur and

could last for up to 26 days. The area of local reaction is generally less than 5 cm in

diameter, but in some cases a larger swelling may occur. Vomiting may occur during

the first hour after vaccination, but no consequential negative effects are observed.

Anaphylactic reactions are uncommon. In case of such reactions, appropriate

treatment is recommended. If left untreated, anaphylactic reactions might be lethal.

Withholding period: Nil

Manufacturer: Zoetis Inc.

2000 Rockford Road Charles City Iowa USA

or

601 West Cornhusker Hwy Lincoln Nebraska USA

Applicant name: Zoetis Australia Pty Ltd

38–42 Wharf Road

West Ryde NSW 2114 AUSTRALIA

SUMMARY OF THE APVMA’S EVALUATION OF RELSURE PCV IN ACCORDANCE WITH SECTION 14(3)(E) AND

(F) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (‘THE AGVET CODE’), SCHEDULED TO THE

AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994

The APVMA has assessed the chemistry and manufacturing aspects of Inactivated Porcine Circovirus Type 1-Type 2

Chimera and the product, including starting materials, master seed organisms (source, identity, and purity), culture

media, vaccine production, quality control, shelf life and batch release analysis, has been assessed and found to meet

APVMA standard.

The APVMA is satisfied that the proposed use of Inactivated Porcine Circovirus Type 1-Type 2 Chimera in the product,

as an aid in the prevention of Porcine Circovirus Type 2 (PCV2) viraemia, as an aid in the prevention of nasal and faecal

shedding, as an aid in the reduction of colonisation, and as an aid in the reduction of lymphoid depletion caused by



PCV2 and in the control of PCV-associated disease, would not be likely to have an effect that is harmful to human

beings, environment or trade. The adjuvant and the excipients used in the product have been previously assessed and

found to be safe. They are already present in vaccines registered for use in Australia.

In relation to its assessment of efficacy and safety in target animal, the APVMA is satisfied that the data supporting the

efficacy and safety of the product, adequately demonstrate that this product is likely to be safe and effective under

Australian conditions when used as directed according to label instructions.

SUMMARY OF THE APVMA’S EVALUATION OF INACTIVATED PORCINE CIRCOVIRUS TYPE 1-TYPE 2 CHIMERA

ACTIVE CONSTITUENT

Constituent Specification

Inactivated Porcine Circovirus Type 1-Type 2 Chimera 1 RP

MAKING A SUBMISSION

In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written

submission as to whether the APVMA should grant the application for approval of the active constituent Inactivated

Porcine Circovirus Type 1-Type 2 Chimera and registration of the product.

Submissions should state the grounds on which they are based. Such grounds should relate only to matters outlined

above that the APVMA is required to take into account in deciding whether to grant the application.

In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission

as to whether the application for approval of Inactivated Porcine Circovirus Type 1-Type 2 Chimera should be granted.

Submissions should relate only to matters that the APVMA is required by legislation to consider in deciding whether to

grant the approval. These grounds include chemistry and manufacture, and toxicity. Submissions should state the

grounds on which they are based. Comments received outside these grounds cannot be considered by the APVMA.

Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact

listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

When making a submission please include a:

contact name

company or group name (if relevant)

email or postal address

the date you made the submission.

All personal and confidential commercial information (CCI)1 material contained in submissions will be treated

confidentially.

Written submissions on the APVMA’s proposal to grant approval for Inactivated Porcine Circovirus Type 1-Type 2

Chimera that relate to the grounds for approval should be addressed in writing to:

1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.

http://www.comlaw.gov.au/ComLaw/Legislation/ActCompilation1.nsf/current/bytitle/A06DDA96E680781ECA2573120082EBE6?OpenDocument&mostrecent=1



Principal Evaluator

Veterinary Medicines Program

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4730

Fax: +61 2 6210 4741


OTHER NOTICES

Cancellation of selected Approvals and Registrations Related to 2,4-D High Volatile

Esters (HVE)

This notice is published in accordance with s.55 of the Agvet Codes.

The APVMA has, effective 21 August 2013:

cancelled the approvals of the active constituents listed in Table 1 below under s.41(1)(c) of the Agvet

Codes

cancelled the registrations of products listed in Table 2 below under s.41(1)(c) of the Agvet Codes

cancelled all related approved labels listed in Table 2 below under s.44(2) of the Agvet Codes.

The APVMA has also cancelled permit PER 13339 (use of suspended 2,4-D HVE products).

Table 1: Cancelled active constituent approvals

ACTIVE CONSTITUENT

NUMBER

ACTIVE CONSTITUENT NAME APPROVAL HOLDER

59931 2,4-D ISOBUTYL ESTER 4FARMERS PTY LTD

52286 2,4-D-ISOBUTYL ESTER RUNGE AGRICHEMS PTY LTD

Table 2: Cancelled product registrations and associated cancelled label approvals

APVMA NO. PRODUCT NAME REGISTRANT LABEL NO.

51110 CHEMAG ESTER 800 HERBICIDE IMTRADE AUSTRALIA PTY LTD 51110/0805

51110/0998

52322 SIPCAM SIESTER 800

HERBICIDE

SIPCAM PACIFIC AUSTRALIA PTY LTD 52322/0200

52322/0103

52322/0805

52322/1005

52591 4FARMERS 2,4-D ESTER 800

HERBICIDE

4FARMERS PTY LTD 52591/0300

52591/0805

54595 HALLEY 2,4-D ESTER 800

HERBICIDE

HALLEY INTERNATIONAL

ENTERPRISE (AUSTRALIA) PTY LTD

54595/0901

54595/0903

54595/0805

54925 CONQUEST ESTER 800

SELECTIVE HERBICIDE

CONQUEST CROP PROTECTION PTY

LTD

54925/0102

54925/0302

54925/0805

54954 KENSO AGCARE KEN-ESTER

800 HERBICIDE

KENSO CORPORATION (M) SDN. BHD. 54954/1201

54954/0805

26

APVMA NO. PRODUCT NAME REGISTRANT LABEL NO.

55079 WSD 2,4-D ESTER 800

HERBICIDE

REBOP HOLDINGS PTY LTD T/A

WESTERN STOCK DISTRIBUTORS

55079/1201

55079/0905

56895 ROTAM 2,4-D ESTER 800

HERBICIDE

ROTAM AUSTRALASIA PTY LTD 56895/0403

56895/0805

58919 CROWN 2,4-D ETHYL ESTER 800

SELECTIVE HERBICIDE

CORONA INDUSTRIES PTY LTD 58919/0105

58919/0805

59653 GENFARM 2,4-D ESTER 800 EC

HERBICIDE

GENFARM CROP PROTECTION PTY

LTD

59653/0605

60523 DOW AGROSCIENCES ESTER

800 HERBICIDE

DOW AGROSCIENCES AUSTRALIA

LIMITED

60523/1105

REASONS

2,4-D is a systemic herbicide used post emergence for the control of broadleaf and grass weeds. The APVMA

commenced a review in relation to the impact of 2,4-D high volatile esters (HVE) on the environment (including

impacts on waterways, non-target animals and plants) in 2003. Following the completion of that aspect of the

review, the APVMA formed the view that, on the presently available information, and having regard to the matters

referred to in s.14(4) and s.14(5) of the Agvet Codes, the continued use of, or any other dealing with, the active

constituents in Table 1and the products in Table 2, in accordance with their instructions for use of for such

dealings, may be likely to have an unintended effect that is harmful to animals, plants or things or to the

environment, for the purposes of s.41(1)(c) of the Agvet Codes. The cancellation action detailed in this notice

was undertaken for that reason.

27

INSTRUCTIONS FOR SUPPLY AND USE OF CANCELLED ACTIVE CONSTITUENTS AND

PRODUCTS

Under s.55(2)(e) of the Agvet Codes, the APVMA has determined the following instructions for the purposes of

this notice:

Import or Manufacture of Cancelled Active Constituents

After 21 August 2013 import or manufacture of any active constituent listed in Table 1 of this notice is not

permitted without written consent of the APVMA.

Import or Manufacture of Cancelled Products

After 21 August 2013 import or manufacture of any product listed in Table 2 of this notice is not permitted without

written consent of the APVMA.

Supply of Cancelled Active Constituents

After 21 August 2013 the supply of any active constituent listed in Table 1 of this notice is not permitted.

Supply of Cancelled Products

After 21 August 2013 supply of the products listed in Table 2 of this notice may only occur until 31 August 2013

as described in APVMA permit PER14329.

After 31 August 2013 supply of any product listed in Table 2 of this notice will constitute an offence under eligible

laws of this jurisdiction.

Use of Cancelled Products

After 21 August 2013 use of the products listed in Table 2 of this notice may only occur in accordance with the

instructions contained in this Notice or in accordance with those contained in APVMA permit PER14329.

After 31 August 2014 use of any product listed in Table 2 of this notice will constitute an offence under eligible


28

INSTRUCTIONS FOR USE OF A 2,4-D HVE PRODUCT UNDER PER14329

READ THESE INSTRUCTIONS before using or otherwise handling the 2,4-D HVE products.

NOTE AND APPLY THE FOLLOWING RESTRAINTS:

The 2,4-D HVE products are PHENOXY HERBICIDES that can cause severe damage to native vegetation and

susceptible crops such as cotton, grapes, tomatoes, oilseed crops and ornamentals.

Use of the 2,4-D HVE products is only permitted between 21 August 2013 and 31 August 2013 and

between 1 May 2014 and 31 August 2014 (inclusive).

DO NOT use the 2,4-D HVE products between 1 September 2013 and 30 April 2014.

DO NOT use the 2,4-D HVE products after 31 August 2014.

DO NOT apply the 2,4-D HVE products by air.

DO NOT apply the 2,4-D HVE products:

in aquatic situations, or

to sugar cane, or

to rights of way, or

as a harvest aid/salvage spray.

DO NOT apply more than 800 g ae/ha (1L of this product per ha) (ae=acid equivalent)

DO NOT apply if crop or weeds are stressed due to dry or excessively moist conditions.

DO NOT use unless wind speed is more than 3 kilometres per hour and less than 15 kilometres per hour as

measured at the application site.

DO NOT apply with spray nozzles smaller than ‘Coarse’ spray droplets according to the ASAE S572 definition for

standard nozzles.

DO NOT apply if rain is likely to occur within 6 hours after the use.

DO NOT apply within a buffer zone of 100 m between field edges and downwind water bodies, native vegetation

and sensitive crops.

WITHHOLDING PERIOD: PASTURE, CEREAL CROPS

DO NOT GRAZE OR CUT PASTURE OR CEREAL CROPS FOR STOCK FOOD FOR 7 DAYS AFTER

APPLICATION.

USE ON FIELD CROPS AND PASTURES

Situation & Crop

Weeds State Rate Withholding Period (days)

Critical Comments

Wheat, Barley Refer to Weed Table on product label

Vic only 180–700 mL/ha 7

CROP STAGES: ALL CEREALS Apply at tillered to boot stages. (Vic only) (DC 30-39) Apply when the first node can be felt at the base of the tiller and before swelling of the head can be felt in a tiller. (NSW only)

Qld, NSW only

350–700 mL/ha

SA only 200–700 mL/ha

WA only

700 mL/ha

29

Situation & Crop


Critical Comments

Triticale Qld, NSW only

350-700mL/ha Apply from mid-tillering to before boot stage. (Qld only) Apply from completion of tillering to early jointing stage. (SA only) Apply from the 5 leaf stage up to jointing stage (Zadoks 15–33). Apply only at 6 leaf stage for cranbrook and jacup wheats (Zadoks 16) to avoid possible damage (WA only).

SA only 200–700 mL/ha

Vic, NSW only

180–700 mL/ha

Cereal Rye Qld, NSW only

350–700 mL/ha

Vic only 180–700 mL/ha

Pastures - Direct Drilling or Surface Sowing

Charlock, Clover, Medics, Mustards, Paterson’s Curse, Saffron, Slender, Variegated and Spear Thistles, Turnip Weed, Wild Radish, Wild Turnip, Capeweed, Wireweed, Storksbill / Erodium, Flatweed, Horehound (seedlings), Skeleton Weed, Nodding or Star Thistles

Qld, WA, Vic NSW only

700 mL–1 L/ha

7 Apply to young, actively growing weeds. SOWING: Do not sow pasture seeds for at least 21 days after application. If soil moisture is dry, delay sowing for at least 30 days.

All of the above plus grasses

As above plus other herbicide such as glyphosate

Improved Pasture containing Clover

Refer Weed Table

Qld, NSW, SA only

350–700 mL/ha 7 Clover must be well covered by the grass or extensive damage may result.

30

Situation & Crop


Critical Comments

Pastures - non legumes,

Refer Weed Table NOTE: the following weeds may not be controlled at these rates Apple of Sodom Black Knapweed Buffalo Burr Colocynth Galvanised Burr Hard Head / Russian Knapweed Nut Grass St Johns Wort Sand Mustard /Sand Rocket Silverleaf Nightshade Thistle - Golden - Nodding - Soldier - Stemless Wild Sage Wild Teasel

Qld, Vic, NSW, SA, WA only

700 mL–1 L/ha Control of most perennial weeds, but due to the rooting habits of most species control may take a number of years. Damage may result to legumes in pasture.

RECORD KEEPING

1 Persons who use a 2,4-D HVE product must make accurate records about each use of each product within

24 hours of the use.

2 Each record must include a signed statement made by the creator stating that the information in the record is

accurate.

3 Records about the use of a 2,4-D HVE product must include details of the product used, including:

a) the name of the product and relevant APVMA registration number, and

b) the batch number of each container of the product used.

4 Records about the use of a 2,4-D HVE product must include detailed information about the time of the use,

including:

c) the date of each use, and

d) the time that each use started, and

e) the time that each use finished.

5 Records about the use of a 2,4-D HVE product must include detailed information about the location of the

use, including:

f) the address of the location where the product was used, and

g) the name of the owner or lessee or tenant of the land, and

h) a map of the farm or other location clearly indicating the areas treated with the product, and

i) the area in hectares treated with the chemical product.

31

6 Records about the use of a 2,4-D HVE product must include detailed information about each person who

used the product, including:

a) name and residential address of each person who used the chemical product, and

b) name and residential address of each person notified of the use of the product (if required

under State/Territory law).

7 Records about the use of a 2,4-D HVE product must include detailed information about the reasons for use

of the product, including:

a) name of the crop or use situation, and

b) name of the weeds treated and their stage of growth.

8 Records about the use of a 2,4-D HVE product must include detailed information about the weather

conditions at the application site during the time of use, including:

a) a general description of the weather throughout the period of use, and

b) estimates or accurate measurements of the temperature during the period that the products

was used (including temperatures at the start and end of the use), and

c) an estimate or accurate measurement of the relative humidity during the period that the product

was used (including the relative humidity at the start and end of the use), and

d) an estimate or accurate measurement of the wind speeds and directions during the period that

the product was used (including the wind speeds and directions at the start and end of the

use).

9 Records about the use of a 2,4-D HVE product must include detailed information about the type and rate of

application of the product, including:

a) the sprayer pressures used, and

b) the type of equipment and size of spray nozzles used, and

c) the speeds of ground application equipment, and

d) the amount of the product applied per hectare, and

e) whether the product was applied as a mixture of other products, and if so the names of the

mixed products and their application rates, and

f) the name of any additives or diluents applied with the product.

10 Records made about the use of a 2,4-D HVE product must be retained for 2 years from the date of use.

11 Records made about the use of a 2,4-D HVE product must be provided to the APVMA or State/Territory

government officers within 48 hours of request.

WARNING

Under s.55(4) of the Agvet Codes, from the date of this notice it is an offence to possess or have custody with the

intent to supply, or to otherwise deal with any 2,4-D isobutyl ester active constituent listed in Table 1 of this notice

or any product listed in Table 2 of this notice otherwise than in accordance with the instructions contained in this

notice or permit PER14329.

After 31 August 2013 supply of any product listed in Table 2 of this notice will constitute an offence under eligible


32

After 31 August 2014 use of any product listed in Table 2 of this notice will constitute an offence under eligible


The maximum penalty that might apply for a breach of s 55(4) is $51,000 for an individual and $255,000 for a

company.

DECLARATIONS FOR THE PURPOSES OF S.45A(5)(C) AND S.55(3)(C) OF THE AGVET CODES

For the purposes of s.45A(5)(c) and s.55(3)(c) of the Agvet Codes, respectively, s.45A(5) and s.55(3) cease to

apply in respect of the active constituents listed in Table 1 of this notice and the products listed in Table 2 of this

notice.

The effect of these declarations is that, from the date of publication of this notice, the chemical products listed in

Table 2 of this notice may only be supplied or used in accordance with APVMA permit PER14329.

APVMA CONTACT

Further information in relation to the cancellations can be found on the APVMA website, www.apvma.gov.au or by

request to the Chemical Review Contact Officer on +61 2 6210 4700 or [email protected].

For any enquiries or further information about this matter, please contact:

Manager Chemical Review


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776





OTHER NOTICES – Cancellation of Label Approval at the Request of the Registrant

Cancellation of Label Approval at the Request of the Registrant

In accordance with Section 42 of the Agvet Code, if an interested or approved person in relation to an approval or

registration has given to the APVMA a written notice requesting the APVMA to cancel the below approval or registration,

the APVMA must give written notice of its decision on the request to the person(s) who made the request.

This Gazette notice satisfies the requirement in section 45A (1) of the Agvet Code, that the APVMA must also give notice

to any other person to whom, in its opinion such a notice should be given.

At the request of the registrant, following the recent approval of a new label for this product, the APVMA has cancelled

the previous label approvals of the following product:

Product No. Product Name Registrant Cancelled Label

Approval

Number

Date of Effect

53076 ROUNDUP READY TO USE

WEEDKILLER

MONSANTO AUSTRALIA

LTD

53076/54717

53076/52154

53076/0910

53076/0709

53076/0508

53076/0605

53076/0405

53076/0101

53076/0500

8 August 2013

The following instructions set out how a person can deal with any product bearing a cancelled label approval.

SUPPLY

A person may supply or cause to be supplied product bearing a cancelled label manufactured prior to 8 August 2013 at

wholesale and retail level, until 8 August 2015.

After 8 August 2015 it will be an offence against the Agvet Codes to have possession or custody of a product bearing a

cancelled label with the intention to supply.

USE

A person may continue to use the product according to its cancelled label instructions until 8 August 2015.

Any person who possesses, has custody of, uses, or otherwise deals with the product bearing a cancelled label in

accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess,

have custody of, use or otherwise deal with the product after the labels have been cancelled until 8 August 2015.

The supply and use of the product bearing a cancelled label must be in accordance with the label instructions, including

any conditions relating to the shelf life or expiry date. It is an offence to possess, have custody of, use, or deal with the

product listed in the table in a manner that contravenes the above instructions.


OTHER NOTICES – Cancellation of Label Approval at the Request of the Registrant

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Chemical Review/AERP Contact Officer

Pesticides Program


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776




OTHER NOTICES – Exemption from Offence Provisions

Exemption from Offence Provisions

EXMEPTION FOR THE PURPOSES OF SECTION 75 AND SECTION 78

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has determined, as provided for under sections

75(1)(b) and 78(1)(b) of the Schedule to the Agricultural and Veterinary Chemical Code Act 1994 (the Agvet Code), that

the products listed below are exempt from the operation of section 75 and section 78 of the Agvet Code.

Products subject to this exemption

1. Velvet Pure Canine Capsules.

2. Velvet Pure Healthy Natural Treats.

3. Velvet Pure Equine Powder.

This exemption is granted for the period of 18 July 2013 to 18 October 2014 inclusive.

While in force this exemption means that while the products are veterinary chemicals, as defined by section 5 of the

Agvet Code, and unregistered, it is not an offence to possess them for the purposes of supply or to supply them.

This exemption can be cancelled or amended at any time by the APVMA.

APVMA CONTACT

For further information please contact:

Manager Compliance

Compliance, Re-registration and Regulator Support


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4796

Fax: +61 2 6210 4813



OTHER NOTICES – Exemption from Offence Provisions

Exemption from Offence Provisions

EXMEPTION FOR THE PURPOSES OF SECTION 75 AND SECTION 78

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has determined, as provided for under sections

75(1)(b) and 78(1)(b) of the Schedule to the Agricultural and Veterinary Chemical Code Act 1994 (the Agvet Code), that

the products listed below are exempt from the operation of section 75 and section 78 of the Agvet Code.

Products subject to this exemption

1. Zagrosol AD3E (oral solution).

2. Amilyte (water soluble powder).

3. Nilstress (water soluble powder).

4. Zagrosol Minpro (oral solution).

5. Zagrosol Aminogen (oral solution).

6. Calpozag (oral solution).

This exemption is granted for the period of 23 August 2013 to 23 August 2014 inclusive.

While in force this exemption means that while the products are veterinary chemicals, as defined by section 5 of the

Agvet Code, and unregistered, it is not an offence to possess them for the purposes of supply or to supply them.

This exemption can be cancelled or amended at any time by the APVMA.

APVMA CONTACT


Assistant Manager Compliance

Compliance, Re-Registration and Regulatory Support


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4800

Fax: +61 2 6210 4813



OTHER NOTICES – Addendum to the Record of Approved Active Constituents

Addendum to the Record of Approved Active Constituents

The current Record of Approved Active Constituents for Registered Chemical Products is also accessible from the

APVMA website, www.apvma.gov.au

APPROVED SINCE GAZETTE NO

For use in agricultural and/or veterinary chemical products:

Common Name Approval Holder Manufacturer and Site of Manufacture Approval No.

Atrazine SHANDONG

BINNONG

TECHNOLOGY CO.,

LTD.

SHANDONG BINNONG TECHNOLOGY CO.,

LTD.

NO. 518 YONGXIN ROAD

BINBEI TOWN

BINZHOU CITY, SHANDONG 256600

PR CHINA

69046

Kresoxim-methyl AGROGILL

CHEMICALS PTY

LTD

YANCHENG LIMIN CHEMICAL FACTORY

NO 18 YANHUAI RD

LONGGANG TOWN

YANCHENG CITY

JIANGSU PROVINCE 224011

PR CHINA

68589

Isoxaflutole WELLFARM PTY LTD JIANGSU AGROCHEM LABORATORY CO.,

LTD

1218 NORTH CHANGJIANG ROAD

WEITANG CHEMICAL INDUSTRY PARK

XINBEI DISTRICT, CHANGZHOU CITY

JIANGSU PROVINCE 213022

PR CHINA

69135

Glyphosate SYNGENTA

AUSTRALIA PTY LTD

ZHEIJIANG XINAN CHEMICAL INDUSTRIAL

GROUP CO., LTD

XINANJIANG, JIANDE

ZHEJIANG 311600

PR CHINA

68339

Ametryn SHANDONG

BINNONG

TECHNOLOGY CO.,

LTD.

SHANDONG BINNONG TECHNOLOGY CO.,

LTD.

NO. 518 YONGXIN ROAD, BINBEI TOWN

BINZHOU CITY, SHANDONG 256600

PR CHINA

69094



OTHER NOTICES – Addendum to the Record of Approved Active Constituents

APVMA CONTACT


Application Management and Enquiries (AME)


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4701

Fax: +61 2 6210 4721



OTHER NOTICES – Application Summaries

Application Summaries

The APVMA publishes complete application summaries on the APVMA website, www.apvma.gov.au. They are published

in weekly instalments using the date the application was accepted for assessment. If an application summary has been

amended, the APVMA will publish the amended version on the website and list it separately in the APVMA Gazette

Notice for Application Summaries.

As a requirement of Regulations 8C and E of the Agvet Code, some product names will appear as 'NOT AVAILABLE'.

A summary will be removed from the website 28 days after the application has been finalised. Therefore, some

summaries published in this notice may have already been removed prior to the Gazette being published.

APPLICATION SUMMARIES PUBLISHED SINCE THOSE PUBLISHED IN APVMA GAZETTE NO. 16

Application No. Name

55218 NOT AVAILABLE

56791 GLYPHOSATE ISOPROPYLAMINE SALT

57726 CANEX MULTI SPECTRUM ALL WORMER FOR LARGE DOGS

58832 CLOMAZONE

59288 NUFARM AMITROLE T HERBICIDE

59289 NUFARM NUQUAT 250 NON-RESIDUAL KNOCKDOWN HERBICIDE

59290 NUFARM AMICIDE ADVANCE 700 SELECTIVE HERBICIDE

59291 CROP CARE ALLIANCE HERBICIDE

59292 NUFARM COMET 400 HERBICIDE

59293 NUFARM TROOPER 75-D HERBICIDE

59382 AC EMPORIUM 500 SEED TREATMENT

59384 AC PYRAMID 250 HERBICIDE

59419 IMTRADE LIMBO 750 WG HERBICIDE

59455 2,4-D

59486 NUFARM BOSS FUNGICIDE

59841 METACAM 1 MG CHEWABLE TABLETS FOR DOGS

59881 METACAM 2.5 MG CHEWABLE TABLETS FOR DOGS

59996 IMAZAPYR

60096 SABAKEM DICAMBA M 420SL SELECTIVE HERBICIDE

60156 AZOXYSTROBIN TECHNICAL

60250 NOT AVAILABLE

60254 NOT AVAILABLE

60271 AGROCHINA GLYPHOSATE 450 SL HERBICIDE





60280 SUREFIRE TURBO 150 GRANULAR INSECTICIDE

60289 UNISTOP DUST SPROUT INHIBITOR

60296 NOT AVAILABLE

60302 NOT AVAILABLE

60310 NOT AVAILABLE

60315 AMETRYN

60319 GLYPHOSATE

60327 SABAKEM DICAMBA 500SL SELECTIVE HERBICIDE

60329 SABAKEM TRIFLURALINK 250EC HERBICIDE

60345 SABAKEM METSULFURON 600WG HERBICIDE

60346 SABAKEM TRALKOXYDIM 400WG HERBICIDE

60348 SABAKEM ETHEPHON 720AC GROWTH REGULATOR

60364 SABAKEM BROMOXYNIL 200EC HERBICIDE

60375 SABAKEM RECKON-B 275EC HERBICIDE

60383 PROTIM OPTIMUM READY-TO-USE PENETRATING LOSP TIMBER PRESERVATIVE

60394 SABAKEM IMAZAPIC 240SL HERBICIDE

60416 FARMALINX DIFLUCAN 500 HERBICIDE

60422 RAID EARTH OPTIONS FLY & MOSQUITO KILLER

60423 RAID EARTH OPTIONS MULTI INSECT KILLER

60424 RAID EARTH OPTIONS AUTOMATIC ADVANCED MULTI-INSECT CONTROL SYSTEM

60441 NUFARM OLANDO HERBICIDE

57066 QUINCLORAC

57724 CANEX MULTI SPECTRUM ALL WORMER FOR MEDIUM DOGS

58655 FMC DIURON 900 WG HERBICIDE

58866 NOT AVAILABLE

58998 NOT AVAILABLE

59205 IMIDACLOPRID

59367 INVICT GOLD COCKROACH BAIT

59417 IMTRADE TURBULENCE 800 WG FUNGICIDE

59480 FIDO'S BEDDING AND JACKET INSECTICIDAL AND DEODORISING SPRAY

59507 NOT AVAILABLE

59513 ROUNDUP READY TO USE WEEDKILLER GEL

59554 AVID TURF MITICIDE




59571 ZELAM BRUSHWEED HERBICIDE

59572 ULTIMATE BRUSH WEED HERBICIDE

59721 TITAN MAX GLYPHOSATE 540K SALT HERBICIDE

59988 COLES 3 IN 1 OUTDOOR, INDOOR & GARDEN SURFACE SPRAY

60009 SUREFIRE PINDONE OAT RABBIT BAIT

60039 HOTSHOT HERBICIDE

60051 PROPICONAZOLE

60068 TRITICONAZOLE

60112 SABAKEM HEXYTHIAZOX 100EC MITICIDE

60113 SABAKEM OMETHOATE 290SL MITICIDE & INSECTICIDE

60122 FMC PENDIMETHALIN 440 EC HERBICIDE

60137 NOT AVAILABLE

60203 2,4-DB

60278 ATRAZINE

60330 SABAKEM METALAXYL 480EC SYSTEMIC FUNGICIDE

60332 SABAKEM RECKON-M 275EC SELECTIVE HERBICIDE

60333 SABAKEM PROPARGITE 600EC MITICIDE

60337 SABAKEM 2,4-D LVE 680 HERBICIDE

60338 SABAKEM MEPIQUAT CHLORIDE 38SL GROWTH REGULATOR

60341 SABAKEM GLYPHOSATE K-TECH 500SL HERBICIDE

60389 SABAKEM PARAQUAT 250SL HERBICIDE

60432 THE FARM EXCHANGE PROPYZAMIDE 500 SC HERBICIDE

60455 NOT AVAILABLE

60457 NOT AVAILABLE

60467 SUREFIRE BENT 100 EC INSECTICIDE

60469 X1525 ANT KILLER

60480 NOT AVAILABLE

60491 FARMALINX TERBUTRYN 500 SC HERBICIDE

55835 NUFARM AVADEX XTRA SELECTIVE HERBICIDE

57461 COUNTRY IPRODIONE 365 SE FUNGICIDE

58802 CHLORANTRANILPROLE

58967 4FARMERS 1080 READY-TO-LAY (RABBIT OAT BAIT)

59308 BACILLUS THURINGIENSIS- SUBSP. ISRAELENSIS




59559 TIAMULABS TIAMULIN SOLUBLE POWDER

59901 DIFLUFENICAN

59994 FORWARD GLYPHOSATE 450 HERBICIDE

60011 FAST ACTION RATSAK REUSABLE RODENT BAIT STATION WITH WAX BLOCKS

60026 NOVAGUARD HEXAZINONE 750 SG HERBICIDE

60127 FMC CAPTAN 900 FUNGICIDE

60158 FORWARD IMIDACLOPRID 600 SEED DRESSING INSECTICIDE

60340 SPALDING METOLACHLOR 720 HERBICIDE

60362 PESTIGARD VACCINE

60380 THIAMETHOXAM

60428 ORION 450 HERBICIDE

60454 TOMAHAWK HERBICIDE

60504 CAPTAN

60512 APPARENT TERBUTRYN-MCPA HERBICIDE

59610 FBC BLOODFOOD BLOOD BUILDING SUPPLEMENT FOR HORSES

APVMA CONTACT


Application Management and Enquiries (AME)


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4701

Fax: +61 2 6210 4721


apvma gazette no. 17, 27 august 2013

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