no. apvma 1, tuesday, 16 january 2018 agricultural and · no. apvma 1, tuesday, 16 january 2018...

No. APVMA 1, Tuesday, 16 January 2018 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 1, Tuesday, 16 January 2018 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2018

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

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

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

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APVMA CONTACTS

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

mailto:[email protected]

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

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


CONTENTS

Agricultural Chemical Products and Approved Labels................................................................................................. 4 Veterinary Chemical Products and Approved Labels ................................................................................................ 31 Approved Active Constituents.................................................................................................................................. 35 Approved Active Constituents—s14A ...................................................................................................................... 37 Approved Active Constituents—s14 ......................................................................................................................... 43 Cancellation of Product Registration and Label Approvals at the Request of the Holder ............................................ 44 Revocation of Suspension of Products Containing Quintozene to Allow Approval of New Labels ............................... 45 Licensing of Veterinary Chemical Manufacturers ...................................................................................................... 46 Amendments to the APVMA MRL Standard ............................................................................................................. 48 Proposal to Amend Schedule 20 of the Australia New Zealand Food Standards Code .............................................. 49


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. RESTRICTED PRODUCT

Application no.: 59511

Product name: Biflex Ultramax Termiticide & Insecticide

Active constituent/s: 200 g/L bifenthrin

Applicant name: FMC Australasia Pty Ltd

Applicant ACN: 095 326 891

Summary of use: For the internal and external protection of structures from subterranean termite damage and for the control of termites and a range of other urban pests

Date of registration: 21 December 2017

Product registration no.: 68966

Label approval no.: 68966/59511

2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Kenso Agcare Ken-Up Dry Super K Herbicide

Active constituent/s: 68 g/kg glyphosate (present as potassium salt)

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

Applicant ACN: N/A

Summary of use: For control of many annual and perennial weeds in non-agricultural areas, agricultural areas, dry drains, forests, cotton, pastures, tree and vine crops, and onions





Product name: Raystar Propyzamide 500 SC Herbicide

Active constituent/s: 500 g/L propyzamide

Applicant name: Raystar Cropprotection Pty Ltd


Summary of use: For selective control of certain grasses and broadleaf weeds in lettuce, sports turf, home lawns, legume seed crops, and pastures





Product name: Evopure Rapid Shock Pool Sanitiser

Active constituent/s: 504 g/kg available chlorine (Cl) present as sodium dichloroiscyanurate, 100 g/kg of sodium tetraborate pentahydrate

Applicant name: Evolution Water and Lighting Solutions Pty Ltd


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







Product name: Conquest Glocker 750 WG Herbicide

Active constituent/s: 750 g/kg picolinafen

Applicant name: Conquest Crop Protection Pty Ltd


Summary of use: For the control of wild radish and the suppression of capeweed in field peas and narrow leaf lupins





Product name: Eureka! Carfentrazone 400 EC Herbicide

Active constituent/s: 400 g/L carfentrazone-ethyl

Applicant name: Eureka! Agresearch Pty Ltd


Summary of use: For improvement in the control of marshmallow and certain other broadleaf weeds prior to establishment of crops, fallows or forest plantations, in commercial, industrial and public service areas, around agricultural buildings and yards, in tree fruits, nuts, grapevines in tank mixture with knockdown herbicides; control of marshmallow and annual nettles in grass pastures and rough grass/turf areas; and control of volunteer cotton seedlings including roundup ready® cotton and desiccation of cotton re-growth





Product name: Genfarm MCPA 750 Selective Herbicide

Active constituent/s: 750 g/L MCPA present as the dimethylamine salt

Applicant name: Landmark Operations Limited


Summary of use: For the selective control of broadleaf weeds in cereals, linseed, pastures, sugar cane and turf





Product name: AgProtect Glyphosate 450 SL Herbicide

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

Applicant name: Agprotect Australasia Pty Ltd


Summary of use: For the control of a broad range of annual, perennial, woody and aquatic weeds and for use in conservation tillage







Product name: Kojak 75D Herbicide

Active constituent/s: 75 g/L picloran present as the triisopropanolamine salt, 300 g/L 2,4-d present as the triisopropanolamine salt

Applicant name: Crop Culture Pty Ltd


Summary of use: For the control of a wide range of annual and perennial broadleaf weeds





Product name: AgProtect Imidacloprid 600 Seed Treatment Insecticide

Active constituent/s: 600 g/L imidacloprid



Summary of use: For the control of various insect pests in a range of crops and the protection of spread of barley yellow dwarf virus in cereal crops





Product name: Clear-out Crawling Insect Aerosol

Active constituent/s: 0.6 g/kg fipronil

Applicant name: Sherwood Chemicals Australasia Pty Ltd


Summary of use: For control of ants and cockroaches in domestic, commercial and public buildings





Product name: AgProtect Chlorpyrifos 500 EC Insecticide

Active constituent/s: 500 g/L chlorpyrifos (an anti-cholinesterase compound)



Summary of use: For control of a wide range of insect pests on fruit, vegetables, oil seeds, cotton, cereals, pasture, turf and other situations





Product name: PestXpert DIY Pest Control Like The Professionals Bedbugs Control Spray

Active constituent/s: 16 g/kg n-octyl bicycloheptene dicarboximide, 4 g/kg d-phenothrin

Applicant name: Sumitomo Chemical Australia Pty Limited


Summary of use: For use in controlling bed bugs and other biting pests in domestic and commercial premises







Product name: Bua Dicamba-M Herbicide

Active constituent/s: 80 g/L dicamba (present as the dimethylamine salt), 340 g/L MCPA (present as the dimethylamine salt)

Applicant name: Business Uplift Pty Ltd


Summary of use: For the control of certain broadleaf weeds in winter cereals, pastures and non-crop areas





Product name: Wipe-Out Pro Herbicide

Active constituent/s: 540 g/L glyphosate present as the monoethanolamine salt

Applicant name: Adama Australia Pty Limited


Summary of use: For the control of a wide range of annual and perennial weeds





Product name: Hempaguard X7 89900 Fouling Defence Coating

Active constituent/s: Black 87.62 g/L copper pyrithione, Red 87.85 g/L copper pyrithione

Applicant name: Hempel (Australia) Pty Ltd

Applicant ACN: 004 721 902 Summary of use: For the prevention of marine biofouling on vessel hulls





Product name: BioGuard Spa Spa Sanitiser

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

Applicant name: Biolab Australia Pty Ltd


Summary of use: For the control of bacteria and algae in spas





Product name: Titan Ethephon 900 SL Growth Regulator

Active constituent/s: 900 g/L ethephon (an anticholinesterase compound)

Applicant name: Titan Ag Pty Ltd


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

Date of registration/approval: 8 December 2017






Product name: Aako Linuron SC Herbicide

Active constituent/s: 450 g/L linuron

Applicant name: Aako Australia Pty Limited


Summary of use: For the control of certain weeds in cereals, potatoes, carrots, coriander, and other crops





Product name: DoUse 1000 Wetting Agent

Active constituent/s: 1000 g/L nonyl phenol and alcohol ethoxylates

Applicant name: Australian Adjuvants Pty Ltd


Summary of use: To increase spray contact, coverage and penetration of herbicides, fungicides and insecticides





Product name: Kingdoxa Insecticide

Active constituent/s: 150 g/L indoxacarb

Applicant name: Gharda Australia Pty Ltd


Summary of use: For the control of various species of insect pests in adzuki beans, chickpeas, cotton, faba beans, mung beans and soybeans





Product name: AgProtect Fluroxypyr 200 EC Herbicide

Active constituent/s: 200 g/L fluroxypyr present as the methyl heptyl ester



Summary of use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, millets, pastures, sorghum, sugarcane, sweet corn and winter cereals. Also for the control of woody weeds in agricultural non-crop areas, commercial and industrial areas, pastures and right-of-ways





Product name: AgProtect Isoxaflutole 750 WG Herbicide

Active constituent/s: 750 g/kg isoxaflutole



Summary of use: For the control and suppression of various broadleaf weeds and grasses in sugar cane and chickpeas







Product name: Selene Plus Insecticide

Active constituent/s: 250 g/L cypermethrin

Applicant name: Industrial Quimica Key, S.A

Applicant ACN: N/A

Summary of use: For the control of pests on cotton, sunflowers, field peas, sweet corn, maize, soy, navy bean, mung bean, sorghum, cereals, and lupins





Product name: Hovex Ant & Wasp Dust Killer

Active constituent/s: 10 g/kg permethrin 25:75

Applicant name: Pascoe's Pty Ltd


Summary of use: For the control of ants, wasps, fleas and bed bugs around the home and garden





Product name: AgProtect Clethodim 240 EC Herbicide

Active constituent/s: 240 g/L clethodim


Applicant ACN: 621 073 023 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





Product name: Raystar Iprodione 250 SC Fungicide

Active constituent/s: 250 g/L iprodione



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







Product name: AgProtect Diflufenican 500 SC Herbicide

Active constituent/s: 500 g/L diflufenican



Summary of use: For the control of certain weeds in clover-based pasture, field peas, lentils, lupins, and oilseed poppy





Product name: AgProtect Epoxiconazole 125 SC Fungicide

Active constituent/s: 125 g/L epoxiconazole



Summary of use: For the control of leaf rust, stripe rust, and septoria nodorum blotch of wheat and leaf rust of barley





Product name: AgProtect Clopyralid 750 WG Herbicide

Active constituent/s: 750 g/kg clopyralid present as the potassium salt



Summary of use: For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures and fallow land





Product name: Blade 510 Herbicide

Active constituent/s: 510 g/L glyphosate (present as the isopropylamine salt)

Applicant name: Ruralco Holdings Limited


Summary of use: For the control of a wide range of annual and perennial weeds in a wide variety of agricultural situations





Product name: Raystar Simazine 900 WG Herbicide

Active constituent/s: 900 g/kg simazine



Summary of use: For the control of weeds in chickpeas, lupins, t-t canola, orchards, vineyards, and certain other horticultural crops and non-crop situations







Product name: Genfarm Clethodim Hi-Load 360 Herbicide

Active constituent/s: 360 g/L clethodim



Summary of use: For the control of certain grass weeds in beetroot, cabbage, canola, celery, cotton, forestry, lettuce, non-bearing fruit trees, onions, ornamentals, peanuts, pulses, potatoes, soybeans and pasture legumes (lucerne, clover and medic), and seed crops and pastures





Product name: AC Palatial 500 Fungicide

Active constituent/s: 500 g/L procymidone

Applicant name: Axichem Pty Ltd


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





Product name: Profeng Bromoxynil 200 Herbicide

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

Applicant name: Profeng Australia Pty Ltd


Summary of use: For the control of weeds in wheat, oats, barley, cereal rye and triticale (alone or undersown), linseed, lucerne, pastures, turf, fallow, non-crop, roadsides and rights-of-way





Product name: Conquest Preceed 800 EC Selective Herbicide

Active constituent/s: 800 g/L prosulfocarb

Applicant name: Conquest Crop Protection Pty Ltd


Summary of use: For the control of annual ryegrass in wheat and barley





Product name: Accensi Fluroxypyr SSD 400 EC Herbicide

Active constituent/s: 400 g/L fluroxypyr present as the methyl heptyl ester

Applicant name: Accensi Pty Ltd


Summary of use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, millets, 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







Product name: PestXpert DIY Pest Control Like The Professionals 2 in 1 Cockroach Bait

Active constituent/s: 0.5 g/kg abamectin, 5 g/kg pyriproxyfen



Summary of use: For the control of German and American cockroaches in domestic and commercial situations





Product name: Sporex Fungicide




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





Product name: Last Supper Zinc Phosphide (Broadacre) Mouse Bait Pellets

Active constituent/s: 25 g/kg zinc phosphide

Applicant name: Wilhelm Rural Pty Ltd

Applicant ACN: 055 833 111 Summary of use: For the control of heavy infestations of mice in agricultural situations





Product name: Raystar Fipronil 200 SC Insecticide

Active constituent/s: 200 g/L fipronil



Summary of use: For the control of various insect pests in asparagus, bananas, brassicas, cotton, forestry, ginger, wine grapevines, mushrooms, pasture, potatoes, sorghum, sugar cane and swede





Product name: AgProtect Glyphosate 700 SG Herbicide

Active constituent/s: 700 g/kg glyphosate (present as the mono-ammonium salt)



Summary of use: For the control of many annual and perennial weeds in certain situations







Product name: Fast Action Roundup G Ready to Use Weedkiller

Active constituent/s: 20.5 g/L nonanoic acid, 15.2 g/L glyphosate (present as the isopropylamine salt)

Applicant name: Monsanto Australia Ltd


Summary of use: For the general control of weeds for the home garden





Product name: Regular Roundup G7.2 Ready to Use Weedkiller

Active constituent/s: 21 g/L nonanoic acid, 7.2 g/L glyphosate present as the isopropylamine salt

Applicant name: Monsanto Australia LTD


Summary of use: For use in killing weeds and grass roots





Product name: Raystar Metsulfuron 600 WG Herbicide

Active constituent/s: 600 g/kg metsulfuron-methyl



Summary of use: For the control of brush and broadleaf weeds in native pastures, rights-of-way, commercial and industrial areas and for the control of certain broadleaf weeds in winter cereal crops





Product name: Victor Rodenticide Grain Bait

Active constituent/s: 0.05 g/kg difenacoum

Applicant name: Lodi S.A.S

Applicant ACN: N/A

Summary of use: For the control of rats and mice in various urban situations





Product name: AquaGuard Clear Two

Active constituent/s: 60 g/L copper (Cu) present as triethanolamine complex

Applicant name: Agent Sales & Services Pty Ltd


Summary of use: For the treatment and prevention of algae in swimming pool water







Product name: Octane Non-Ionic Extender-Sticker-Spreader

Active constituent/s: 859 g/L di-1-p-menthene

Applicant name: Agspec Australia Pty Ltd


Summary of use: For use as a sticking-extending agent designed to control the life of pesticides. It is compatible in the spray tank with insecticides, fungicides and soluble fertilisers





Product name: Cerecarb Herbicide


Applicant name: Shandong Rainbow International Co., Ltd

Applicant ACN: N/A

Summary of use: For control of annual rye grass and toad rush in wheat and barley crops





Product name: EuroChem Penetrant Adjuvant

Active constituent/s: 1020 g/L polyether modified polysiloxane

Applicant name: TGAC Australia Pty. Ltd.


Summary of use: For use with agricultural pesticides





Product name: AgProtect Lambda 250 CS Insecticide

Active constituent/s: 250 g/L lambda-cyhalothrin



Summary of use: For the control of certain insect pests in cotton, barley, wheat and various field crops





Product name: AgProtect Simazine 900 WG Herbicide

Active constituent/s: 900 g/kg simazine



Summary of use: For the control of weeds in chickpeas, lupins, T-T canola, orchards, vineyards, and certain other horticultural crops and non-crop situations

Date of registration: 2 January 2018






Product name: Titan Prosulfocarb 800 EC Herbicide


Applicant name: Titan Ag Pty Ltd


Summary of use: For control of annual ryegrass and various other weeds in wheat





Product name: Prothene Xtra 970 SG Insectcide

Active constituent/s: 970 g/kg acephate (an anticholinesterase compound)

Applicant name: FMC Australasia Pty Ltd


Summary of use: For the control of certain insect pests on bananas, crucifers, macadamias, ornamentals, potatoes, tomatoes and tobacco





Product name: Amgrow Eraze Total Weed Killer


Applicant name: Amgrow Pty Ltd

Applicant ACN: 100 684 786 Summary of use: For use in aquatic environments and in the garden around aquatic areas





Product name: Roxy Extra Fungicide

Active constituent/s: 200 g/L azoxystrobin, 80 g/L cyproconazole



Summary of use: For control of certain fungal diseases in barley, wheat and peanuts

Date of registration/approval: 4 January 2018



3. VARIATIONS OF REGISTRATION


Product name: Paraquick 250 Herbicide

Active constituent/s: 250 g/L paraquat present as paraquat dichloride



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON PARAQUICK 250 HERBICIDE’ to ‘PARAQUICK 250 HERBICIDE’

Date of variation: 19 July 2017






Product name: Glyphix 360 Herbicide




Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON GLYPHIX 360 HERBICIDE’ to ‘GLYPHIX 360 HERBICIDE’





Product name: Glyphix 450 Herbicide




Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘REYLON GLYPHIX 450 HERBICIDE’ to ‘GLYPHIX 450 HERBICIDE’





Product name: Glyphix Max 540 Herbicide

Active constituent/s: 540 g/L glyphosate (present as the potassium salt)



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘REYLON GLYPHIX MAX 540 HERBICIDE’ to ‘GLYPHIX MAX 540 HERBICIDE’





Product name: Trix 600EC Herbicide

Active constituent/s: 600 g/L triclopyr present as the butoxyethyl ester



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON TRIX 600EC HERBICIDE’ to ‘TRIX 600EC HERBICIDE’







Product name: Paraquick Force 350 Herbicide

Active constituent/s: 350 g/L paraquat present as paraquat dichloride



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON PARAQUICK FORCE 350 HERBICIDE’ to ‘PARAQUICK FORCE 350 HERBICIDE’





Product name: Triflon 480EC Herbicide

Active constituent/s: 480 g/L trifluralin



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON TRIFLON 480EC HERBICIDE’ to ‘TRIFLON 480EC HERBICIDE’





Product name: Triamate 500EC Herbicide

Active constituent/s: 500 g/L tri-allate



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON TRIAMATE 500EC HERBICIDE’ to ‘TRIAMATE 500EC HERBICIDE’





Product name: Triflon 480EC Herbicide

Active constituent/s: 480 g/L trifluralin



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON TRIFLON 480EC HERBICIDE’ to ‘TRIFLON 480EC HERBICIDE’







Product name: Metola-S 960 Herbicide

Active constituent/s: 960 g/L s-metolachlor



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON METOLA-S 960 HERBICIDE’ to ‘METOLA-S 960 HERBICIDE’





Product name: Optane LV 680 Herbicide

Active constituent/s: 680 g/L 2,4-D present as the 2-ethylhexyl ester



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON OPTANE LV 680 HERBICIDE’ to ‘OPTANE LV 680 HERBICIDE’





Product name: Prozam 500SC Herbicide

Active constituent/s: 500 g/L propyzamide



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON PROZAM 500SC HERBICIDE’ to ‘PROZAM 500SC HERBICIDE’

Date of variation: 1 August 2017




Product name: Persista 800EC Herbicide




Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON PERSISTA 800EC HERBICIDE’ to ‘PERSISTA 800EC HERBICIDE’







Product name: Oxon 240EC Herbicide

Active constituent/s: 240 g/L oxyfluorfen



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON OXON 240EC HERBICIDE’ to ‘OXON 240EC HERBICIDE’





Product name: Metrion 750WG Herbicide

Active constituent/s: 750 g/kg metribuzin



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON METRION 750WG HERBICIDE’ to ‘METRION 750WG HERBICIDE’





Product name: Alphanex 100EC Insecticide

Active constituent/s: 100 g/L alpha-cypermethrin



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON ALPHANEX 100EC INSECTICIDE’ to ‘ALPHANEX 100EC INSECTICIDE’





Product name: Dimex 400EC Insecticide

Active constituent/s: 400 g/L dimethoate (an anticholinesterase compound)



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON DIMEX 400EC INSECTICIDE’ to ‘DIMEX 400EC INSECTICIDE’





Product name: Carpenter 240EC Herbicide

Active constituent/s: 240 g/L carfentrazone-ethyl



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON CARPENTER 240EC HERBICIDE’ to ‘CARPENTER 240EC HERBICIDE’







Product name: Splice 700WG Herbicide

Active constituent/s: 700 g/kg imazethapyr



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON SPLICE 700WG HERBICIDE’ to ‘SPLICE 700WG HERBICIDE’





Product name: Anon 600WG Herbicide

Active constituent/s: 600 g/kg metsulfuron methyl



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON ANON 600WG HERBICIDE’ to ‘ANON 600WG HERBICIDE’





Product name: Flume 800WG Herbicide

Active constituent/s: 800 g/kg flumetsulam


Applicant ACN: 009 660 879 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘RELYON FLUME 800WG HERBICIDE’ to ‘FLUME 800WG HERBICIDE’





Product name: Ballista 750WG Herbicide

Active constituent/s: 750 g/kg halosulfuron-methyl



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON BALLISTA 750WG HERBICIDE’ to ‘BALLISTA 750WG HERBICIDE’





Product name: Bite Shield Mosquito Coils

Active constituent/s: 2 g/kg d-allethrin

Applicant name: Mayo Hardware Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘CLASSIC MOSQUITO COILS’ to ‘BITE SHIELD MOSQUITO COILS’







Product name: Nufarm Calibre 100 EC Miticide

Active constituent/s: 100 g/L hexythiazox

Applicant name: Nufarm Australia Limited


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘CROP CARE CALIBRE 100 EC MITICIDE’ to ‘NUFARM CALIBRE 100 EC MITICIDE’

Date of variation: 28 September 2017




Product name: Mueso 720 Fungicide

Active constituent/s: 720 g/L chlorothalonil



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON MUESO 720 FUNGICIDE’ to ‘MUESO 720 FUNGICIDE’

Date of variation: 5 October 2017




Product name: Pictric Herbicide

Active constituent/s: 300 g/L triclopyr present as the butoxyethyl ester 100 g/L picloram present as hexyloxypropylamine salt



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON PICTRIC HERBICIDE’ to ‘PICTRIC HERBICIDE’





Product name: Mueso 900WG Fungicide

Active constituent/s: 900 g/kg chlorothalonil



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON MUESO 900WG FUNGICIDE’ to ‘MUESO 900WG FUNGICIDE’





Product name: Quali-Pro Compass Fungicide

Active constituent/s: 500 g/L fluazinam



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘COMPASS FUNGICIDE’ to ‘QUALI-PRO COMPASS FUNGICIDE’







Product name: Bolt 200EC Herbicide

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



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON BOLT 200EC HERBICIDE’ to ‘BOLT 200EC HERBICIDE’





Product name: Scout 750 Herbicide

Active constituent/s: 750 g/L MCPA present as the dimethylamine salt



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RELYON SCOUT 750 HERBICIDE’ to ‘SCOUT 750 HERBICIDE’





Product name: Claw 350SL Herbicide

Active constituent/s: 350 g/L imazamox present as the ammonium salt



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘CROP CARE CLAW 350SL HERBICIDE’ to ‘CLAW 350SL HERBICIDE’





Product name: Ambicide Multipurpose Biocide

Active constituent/s: 118.94 g/L didecyl dimethyl ammonium chloride, 72.75 g/L n,n-bis-(3-aminopropyl)-dodecylamine

Applicant name: Alltech Lienert Australia Pty. Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘ANTEC AMBICIDE MULTIPURPOSE BIOCIDE’ to ‘AMBICIDE MULTIPURPOSE BIOCIDE’







Product name: Hyperox Farm Disinfectant

Active constituent/s: 254.8 g/L hydrogen peroxide, 61.6 g/L acetic acid, 50 g/L peracetic acid

Applicant name: Alltech Lienert Australia Pty. Ltd.


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘ANTEC HYPEROX FARM DISINFECTANT’ to ‘HYPEROX FARM DISINFECTANT’





Product name: Richgro Ant, Spider And Cockroach Killer Concentrate

Active constituent/s: 30 g/kg permethrin 25:75

Applicant name: A. Richards Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RICHGRO PERMETHRIN ANT, SPIDER AND ROACH KILLER’ to ‘RICHGRO ANT, SPIDER AND COCKROACH KILLER CONCENTRATE’

Date of variation: 7 November 2017




Product name: Titan CC & Dry OTT GLY 700 Herbicide

Active constituent/s: 700 g/kg glyphosate present as the mono-ammonium salt Applicant name: Titan AG Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘TITAN COTTON AND DRY GLYPHOSATE 700 HERBICIDE’ to ‘TITAN CC & DRY OTT GLY 700 HERBICIDE’





Product name: Biosolve HDD Heavy Duty Detergent

Active constituent/s: 63 g/L sodium metasilicate, 38 g/L quaternary ammonium compound

Applicant name: Alltech Lienert Australia Pty. Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘ANTEC HDD HEAVY DUTY DISINFECTANT DETERGENT’ to ‘BIOSOLVE HDD HEAVY DUTY DETERGENT’







Product name: Farmalinx Fizzle Insecticide

Active constituent/s: 250 g/L lambda-cyhalothrin

Applicant name: Farmalinx Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘FARMALINX FIGHTER INSECTICIDE’ to ‘FARMALINX FIZZLE INSECTICIDE’





Product name: Jubilee Loaded Fungicide

Active constituent/s: 500 g/L flutriafol



Summary of variation: To add a pack size range, to update safety directions and precaution statements on the label

Date of variation: 4 December 2017




Product name: Dazide Enhance Plant Growth Regulator

Active constituent/s: 850 g/kg daminozide

Applicant name: Fine Agrochemicals Limited

Applicant ACN: N/A Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘DAZIDE

PLANT GROWTH REGULATOR’ to ‘DAZIDE ENHANCE PLANT GROWTH REGULATOR’





Product name: Mortein Powergard Flying Insect Killer

Active constituent/s: 0.9 g/kg d-allethrin 20:80, 0.9 g/kg d-phenothrin 20:80, 3.15 g/kg tetramethrin 20:80

Applicant name: Reckitt Benckiser (Australia) Pty Limited


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘PEA-BEU INSECT KILLER KILLS FLIES AND GERMS ON CONTACT FAST KILL LOW IRRITANT ANTI BACTERIAL’ to ‘MORTEIN POWERGARD FLYING INSECT KILLER’; add pack sizes; and add additional claim on residual killing action on flies





Product name: Ammo 625 Herbicide

Active constituent/s: 625 g/L 2,4-d present as the dimethylamine and diethanolamine sa



Summary of variation: To change the pack size range to include smaller pack sizes







Product name: Farmalinx Spartacus 250 SC Fungicide

Active constituent/s: 250 g/L azoxystrobin

Applicant name: Farmalinx Pty Ltd


Summary of variation: To update the application rate for poppies




Application no.: 112893 Product name: International Micron 77 Biolux SPC True SPC Antifouling

Active constituent/s: black label: 63g/L copper pyrithione, 567g/L copper present as cuprous oxide red label: 60g/L copper pyrithione, 487g/L copper present as cuprous oxide navy label: 62g/L copper pyrithione, 555g/L copper present as cuprous oxide blue label: 61g/L copper pyrithione, 512g/L copper present as cuprous oxide

Applicant name: Akzo Nobel Pty Limited


Summary of variation: To replace a restraint statement





Product name: Surefire Stellar Fungicide


Applicant name: PCT Holdings Pty Ltd







Product name: Affix 250 SC Fungicide


Applicant name: UPL Australia Limited







Product name: Kenso Agcare Ken-Met 600 WG Herbicide

Active constituent/s: 600 g/kg metsulfuron-methyl

Applicant name: Kenso Corporation (M) Sdn. Bhd

Applicant ACN: N/A

Summary of variation: To make updates to the tank mix products







Product name: Umbrella 905 Extender Sticker Spreader

Active constituent/s: 905 g/L di-1-p-menthene

Applicant name: Amgrow Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from 'UMBRELLA 905 NON-IONIC STICKER SPREADER' to 'UMBRELLA 905 EXTENDER STICKER SPREADER' and to include extender uses





Product name: Silverado Herbicide

Active constituent/s: 60 g/kg carfentrazone-ethyl, 375 g/kg MCPA present as the sodium salt

Applicant name: Turf Culture Pty Ltd


Summary of variation: To extend approved pack size range





Product name: Kenso Agcare Ken-Up Dry 680 WG Herbicide

Active constituent/s: 680 g/kg glyphosate present as the mono-ammonium salt

Applicant name: Kenso Corporation (M) SDN. BHD

Applicant ACN: N/A

Summary of variation: To add use in glyphosate resistant cotton





Product name: Dedicate Turf and Ornamental Fungicide

Active constituent/s: 100 g/L trifloxystrobin, 200 g/L tebuconazole

Applicant name: Bayer Cropscience Pty Ltd


Summary of variation: To extend use to include a range of fungal diseases in ornamentals and to vary application water rates to allow for application at lower volume





Product name: Ranman 400 SC Fungicide

Active constituent/s: 400 g/L cyazofamid

Applicant name: Ishihara Sangyo Kaisha, Ltd

Applicant ACN: N/A

Summary of variation: To extend use to include control of pythium spp. in turf







Product name: Nominee Herbicide

Active constituent/s: 100 g/L bispyribac-sodium



Summary of variation: To include use on couch grass





Product name: Buttress Selective Herbicide

Active constituent/s: 500 g/L 2,4-d b present as the dimethylamine salt



Summary of variation: To extend pack size range and vary labelling information





Product name: Bioguard Lite Pool Oxidiser

Active constituent/s: 372 g/kg chlorine (Cl) present as sodium dichloroisocyanurate

Applicant name: Biolab Australia Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from 'BIOGUARD LITE POOL OXIDISER’ to 'POOL OXIDISER LITE', and to add additional pack sizes





Product name: Delaval Chlortech Heavy Duty Dairy Cleaner

Active constituent/s: 38 g/kg chlorine present as sodium dichloroisocyanurate, 586 g/kg sodium hydroxide

Applicant name: Delaval Pty Ltd


Summary of variation: To update directions for use and storage and disposal information





Product name: Confidor Guard Soil Insecticide

Active constituent/s: 350 g/L imidacloprid

Applicant name: Bayer Cropscience Pty Ltd


Summary of variation: To extend use to include the suppression of citrus gall wasp (bruchophagus fellis) in citrus orchards







Product name: Flute 50 EW Fungicide

Active constituent/s: 50 g/L cyflufenamid

Applicant name: Agnova Technologies Pty Ltd


Summary of variation: To add an alternative rate of application for control of powdery mildew on grapevines





Product name: Genfarm Panzer 450 Herbicide




Summary of variation: To update label recommendations and add pack sizes





Product name: Protect-Us Dominate Insecticide

Active constituent/s: 100 g/L fipronil

Applicant name: Ensystex Australasia Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘HYMENOPTHOR ULTRA LIQUID ANT KILLER’ to ‘PROTECT-US DOMINATE INSECTICIDE’ and to extend uses for the control of millipedes, house, crickets, earwigs and nesting ants





Product name: AW Xobin 250SC Fungicide


Applicant name: Agri West Pty Limited







Product name: Accolade 250 SC Fungicide


Applicant name: Sipcam Pacific Australia Pty Ltd









Product name: Combat Roach Killing Bait Strips

Active constituent/s: 0.1 g/kg fipronil

Applicant name: Henkel Australia Pty Ltd


Summary of variation: To make amendment to claims and add pack sizes





Product name: Avithor Bird Away Visual & Olfactory Bird Repellent

Active constituent/s: 30 g/kg peppermint oil, 50 g/kg white pepper

Applicant name: Ensystex Australasia Pty Ltd


Summary of variation: To approve a new label for the product 'AVITHOR BIRD AWAY VISUAL & OLFACTORY BIRD REPELLENT' with the label name 'PROTECT-US BIRD STOP VISUAL & OLFACTORY BIRD REPELLENT'





Product name: Farmoz Spiral Aquaflo Fungicide




Summary of variation: To extend the use to canola, lentils, and lupins





Product name: Winter Grass Killer for Buffalo & Couch Lawns

Active constituent/s: 100 g/kg propyzamide

Applicant name: Turf Culture Pty Ltd


Summary of variation: To approve a new label for the product 'WINTER GRASS KILLER FOR BUFFALO & COUCH LAWNS ' with the label name 'AMGROW WINTER GRASS KILLER'





Product name: AC Axistrobin 250 SC Fungicide


Applicant name: Axichem Pty Ltd









Product name: Pictric Herbicide

Active constituent/s: 100 g/L picloram present as the hexyloxypropylamine salt, 300 g/L triclopyr present as the butoxyethyl ester



Summary of variation: To increase approved pack size range

Date of variation: 2 January 2018





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


Product name: Curacef Duo Suspension for Injection for Cattle

Active constituent/s: 50 mg/mL ceftiofur (as hydrochloride), 150 mg/mL ketoprofen

Applicant name: Virbac (Australia) Pty Ltd


Summary of use: For the treatment of bacterial respiratory infections in cattle





Product name: Lucizine Liquid Blowfly Treatment for Sheep

Active constituent/s: 500 g/L cyromazine

Applicant name: Abbey Laboratories Pty Ltd


Summary of use: For the control of blowfly strike (lucilia cuprina), which includes organophosphate resistant strains in long wool sheep for up to fourteen weeks





Product name: Cattle-Mate Injection

Active constituent/s: 100 mcg/ml gonadorelin (as acetate)

Applicant name: Randlab Australia Pty Ltd


Summary of use: For use in oestrus synchronization programs in combination with PGF2α. For the treatment of cystic ovaries, prevention of delayed ovulation and improvement of post partum fertility in cattle





Product name: Alfaxan Multi Anaesthetic Injection

Active constituent/s: 10 mg/mL alfaxalone

Applicant name: Jurox Pty Limited


Summary of use: For the induction and maintenance of anaesthesia in dogs and cats







Product name: Y-TEX© PYthon Insecticidal Cattle Strip

Active constituent/s: 200 g/kg piperonyl butoxide, 100 g/kg zeta-cypermethrin



Summary of use: For control of susceptible buffalo flies and aids in control of cattle biting lice on beef and dairy cattle and aids in control of paralysis tick on suckling beef and dairy calves





Product name: Toromax LV Cattle Pour-on Endectocide for Cattle

Active constituent/s: 10 g/L ivermectin

Applicant name: The Hunter River Company Pty Limited


Summary of use: For use in the treatment and control of ivermectin sensitive internal and external parasites of beef and dairy cattle





Product name: Exitraz EC Cattle and Pig Spray

Active constituent/s: 125 g/L amitraz



Summary of use: For the control of organophosphate and synthetic pyrethroid resistant cattle tick, paralysis tick and bush tick on beef and dairy cattle and cattle tick on sheep, goats, deer and certain circus animals in NSW only and mange on pigs





Product name: Synovex La Plus Growth And Finishing Implants For Steers And Heifers

Active constituent/s: 200 mg/implant trenbolone acetate, 28 mg/implant oestradiol benzoate

Applicant name: Zoetis Australia Pty Ltd


Summary of use: For increased rate of weight gain and improved feed efficiency for up to 200 days in steers and heifers fed in confinement for slaughter







Product name: Synovex LA 400 Growth and Finishing Implants for Steers and Heifers

Active constituent/s: 150 mg/implant trenbolone acetate, 21 mg/implant oestradiol benzoate



Summary of use: For increased rate of weight gain for up to 400 days in steers and heifers (slaughter, stocker, feeder) on good quality nutrition





Product name: Mastadry

Active constituent/s: 300 mg/syringe ampicillin (as trihydrate), 600 mg/syringe cloxacillin (as benzathine salt)

Applicant name: Norbrook Laboratories Australia Pty Limited


Summary of use: For the control of mastitis caused by ampicillin and cloxacillin-sensitive bacteria in dairy cows during the dry period





Product name: Encore Pour-On Lousicide For Sheep

Active constituent/s: 35 g/L Imidacloprid



Summary of use: For the control of body lice (bovicola ovis) in sheep





Product name: Adaptil Spray

Active constituent/s: 15.72 mg/mL synthetic analogue of the canine appeasing pheromone

Applicant name: Ceva Animal Health Pty Ltd


Summary of use: An aid to help comfort puppies and adult dogs in stressful situations






2. VARIATIONS OF REGISTRATION


Product name: Ceprotect DC

Active constituent/s: 89.9 g/kg cephalonium (as cephalonium dihydrate)



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘CEPROTECTTM DC’ to ‘CEPROTECT DC’






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


Active constituent/s: Prothiofos

Applicant name: Arysta Lifescience North America LLC

Applicant ACN: N/A

Summary of use: For use in agricultural chemical products

Date of approval: 5 December 2017

Approval no.: 84251


Active constituent/s: Chlorantraniliprole

Applicant name: Shandong Rainbow International CO., Ltd

Applicant ACN: N/A



Approval no.: 84500


Active constituent/s: Epoxiconazole

Applicant name: Zhejiang Yingxin Chemical Co. Ltd

Applicant ACN: N/A



Approval no.: 84530


Active constituent/s: Acetamiprid





Approval no.: 84541


Active constituent/s: Diafenthiuron





Approval no.: 84581




Active constituent/s: Trifloxystrobin





Approval no.: 84557


Active constituent/s: 1-methylcyclopropene

Applicant name: Decco Worldwide Post-Harvest, BV

Applicant ACN: N/A



Approval no.: 84620



Approved Active Constituents—s14A

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.



Active constituent/s: Ceftiofur Crystalline Free Acid



Summary of use: For use in veterinary chemical products


Approval no.: 84619


Active constituent/s: Monensin Sodium

Applicant name: Dox-Al Australia Pty Ltd




Approval no.: 84568


Active constituent/s: Derquantel





Approval no.: 84591


Active constituent/s: Cobalt Sulphate Heptahydrate





Approval no.: 84352


Active constituent/s: Trimethoprim

Applicant name: Ausrichter Pty Ltd




Approval no.: 84788




Active constituent/s: Trimethoprim

Applicant name: Virbac (Australia) Pty Ltd




Approval no.: 84789


Active constituent/s: Benzethonium Chloride





Approval no.: 84790


Active constituent/s: Infectious Laryngotracheitis Virus Strain SA2





Approval no.: 84634


Active constituent/s: Marbofloxacin





Approval no.: 84764


Active constituent/s: Coumaphos

Applicant name: Bayer Australia Ltd (Animal Health)




Approval no.: 84696


Active constituent/s: Potassium L-Aspartate





Approval no.: 84648




Active constituent/s: Calcium Gluconate





Approval no.: 84698


Active constituent/s: Meloxicam

Applicant name: Bimeda (Australia) Pty Limited




Approval no.: 84908


Active constituent/s: Iodine as Ethylene Diamine Dihydroiodide





Approval no.: 84596


Active constituent/s: Choline Chloride





Approval no.: 84699


Active constituent/s: Benazepril Hydrochloride

Applicant name: Chanelle Pharmaceuticals Manufacturing Ltd

Applicant ACN: N/A



Approval no.: 84837


Active constituent/s: D-Phenylalanine





Approval no.: 85205




Active constituent/s: Bacitracin as Bacitracin Methylene Disalicylate





Approval no.: 83677


Active constituent/s: Cobalt (II) Sulphate





Approval no.: 84692


Active constituent/s: Chlortetracycline Hydrochloride

Applicant name: CCD Animal Health Pty Ltd




Approval no.: 84818


Active constituent/s: Ceftiofur Sodium




Date of approval: 3 January 2018

Approval no.: 84653


Active constituent/s: Marek's Disease Live Virus Strain CVI988





Approval no.: 84664


Active constituent/s: Dexmedetomidine Hydrochloride

Applicant name: Orion Corporation

Applicant ACN: N/A



Approval no.: 84675




Active constituent/s: Neomycin Sulphate





Approval no.: 85195


Active constituent/s: Detomidine Hydrochloride





Approval no.: 84830


Active constituent/s: Procaine Penicillin





Approval no.: 85206


Active constituent/s: Omeprazole

Applicant name: Cipla Ltd

Applicant ACN: N/A



Approval no.: 84834


Active constituent/s: Progesterone





Approval no.: 84903


Active constituent/s: Selenium Sulphide

Applicant name: Vetsense Pty Ltd




Approval no.: 85681




Active constituent/s: Butaphosphan





Approval no.: 84960


Active constituent/s: Moxidectin





Approval no.: 85021


Active constituent/s: Abamectin





Approval no.: 84969


Active constituent/s: Fenbendazole

Applicant name: Kato Laboratories Pty Ltd




Approval no.: 85089

2. VARIATIONS OF ACTIVE CONSTITUENT


Active constituent/s: Eprinomectin

Applicant name: Neove Pharma Australia Pty Limited


Summary of variation: Variation of relevant particulars or conditions of an approved active constituent


Approval no.: 82962



Approved Active Constituents—s14

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.


N/A

2. VARIATIONS OF ACTIVE CONSTITUENT


Active constituent/s: Benazepril Hydrochloride





Approval no.: 82884


Active constituent/s: Propineb

Applicant name: Sabero Australia Pty Limited




Approval no.: 83138

Approved Active Constituents—s14


Cancellation of Product Registration and Label Approvals at the Request of the Holder

At the request of the holder, the APVMA has cancelled the registration and the associated label approvals of the following products:

Product no. Product name Registrant/approval holder Cancelled label approvals

Date of effect

39839 Panalog Ointment Elanco Australasia Pty Ltd 39839/01A

39839/0305

39839/59345

13 December 2017

47041 Vulketan Wound Gel for Horses

Elanco Australasia Pty Ltd 47041/0798 13 December 2017

The following instructions set out how a person can deal with the cancelled product registrations and associated label approvals.

SUPPLY

A person may supply or cause to be supplied products manufactured prior to 13 December 2017 at wholesale and retail level, until the 13 December 2018.

After 13 December 2018 it will be an offence against the Agvet Codes to have possession or custody of the product registrations and associated label approvals mentioned in the above table with the intention to supply, or to supply the products.

USE

A person may continue to use the product registration according to its label instructions until 13 December 2018.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product registrations and associated label approvals 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 products listed above after the registrations has been cancelled until 13 December 2018.

The supply and use of the products must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the products listed in the table above in a manner that contravenes the above instructions. APVMA CONTACT

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

Chemical Review Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2609 Phone: +61 2 6210 4749 Fax: +61 2 6210 4776 Email: [email protected]

Cancellation of Product Registration and Label Approvals at the Request of the Holder



Revocation of Suspension of Products Containing Quintozene to Allow Approval of New Labels

On 13 October 2017 the APVMA revoked the suspension of the following quintozene product registrations:

Product no. Product name Registrant Approved label

47211 Barmac Chloroturf DG Fungicide Amgrow Pty Ltd

47211/112263

48308 Barmac Rhysol DG Turf Fungicide 48308/112267

53533 Terraclor Soil Fungicide 53533/112269

The suspension of the above product registrations has been revoked to allow the approval of new labels with instructions consistent with those issued by the APVMA in 2010 for the continued use of quintozene products.

APVMA CONTACT

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

Chemical Review Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4749 Fax: +61 2 6210 4776 Email: [email protected]

Revocation of Suspension of Products Containing Quintozene to Allow Approval of New Labels

http://portal/Product/Products/Product/48308

http://portal/Product/Products/Product/53533



Licensing of Veterinary Chemical Manufacturers

Pursuant to Part 8 of the Agricultural and Veterinary Chemicals Code (Agvet Code), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has taken action with respect to the licensing of the following veterinary chemical manufacturers with effect from the dates shown.

For a comprehensive listing of all licensed manufacturers please see the APVMA’s website www.apvma.gov.au.

1. NEW LICENCES

The APVMA has issued the following licences under subsection 123(1) of the Agvet Code:

Nil

2. CHANGES TO EXISTING LICENCES

The APVMA has issued the following licences under subsection 123(1) of the Agvet Code:

PARNELL MANUFACTURING PTY LTD

LICENCE NO: 1088

ACN: 138 251 582

Unit 4, Century Estate

476 Gardeners Road

ALEXANDRIA NSW 2015

Product Types: *

• Category 1: sterile products

• Category 2: pastes, powders and suspensions

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, dry milling, wet milling, filling, aseptic filling, packaging, labelling, sterilisation (heat and filtration), microbiological reduction treatment (heat, chemical and filtration), analysis and testing (physical, chemical and microbiological), storage and release for supply.

Amended Licence Issued: 13 December 2017

PHIBRO ANIMAL HEALTH PTY LIMITED

LICENCE NO: 6209

ACN: 093 869 991

1/7–10 Denoci Close

WETHERILL PARK NSW 2164

Product Types:*

• Category 6: Single step manufacture

Step(s) of Manufacture: Quality assurance (QA) of raw materials, labelling, relabelling, storage and release for supply.

Licence Issued: 20 December 2017

* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: Single-step manufacturer Licensing of Veterinary Chemical Manufacturers

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


3. LICENCE CANCELLATIONS

The APVMA has cancelled the following licences under subsection 127(1) of the Agvet Code:

ELANCO ANIMAL HEALTH A DIVISION OF ELI LILLY AUSTRALIA PTY LTD

Licence number: 6150

ACN: 000 233 992

112 Wharf Road

WEST RYDE NSW 2114

Date cancelled: 19 December 2017

4. LICENCE SUSPENSIONS

The APVMA has suspended the following licences under subsection 127(1) of the Agvet Code:

NEW HORIZONS ENTERPRISES LIMITED

Licence number: 6076

ACN: 002 066 604

15 Twin Road

NORTH RYDE NSW 2113

Period of suspension: 26 January 2018 to 26 July 2018

5. REVOCATION OF LICENCE CANCELLATION

The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agvet Code:

Nil

6. REVOCATION OF LICENCE SUSPENSION

The APVMA has revoked the suspension of the following licences under subsection 127(7) of the Agvet Code:

Nil

APVMA CONTACT

Manufacturing Quality and Licensing Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4899 Email: [email protected]

* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: Single-step manufacturer Licensing of Veterinary Chemical Manufacturers



Amendments to the APVMA MRL Standard

The Australian Pesticides and Veterinary Medicines Authority (APVMA) approves maximum residue limits (MRLs) of agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. The MRLs approved by the APVMA are associated with a regulatory decision to register a product, grant a permit approval, or as an outcome from a review decision and are set out in the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012. The MRL Standard lists MRLs of substances that may arise from the approved use of agricultural and veterinary chemical products containing those substances on commodities used for human consumption as well as livestock feeds. The MRL Standard also provides the relevant residue definitions to which these MRLs apply. There may be situations where the residue definition for monitoring and enforcement is different to the definition used for dietary risk assessment purposes.

MRLs are set at levels which are not likely to be exceeded if the agricultural or veterinary chemicals are used in accordance with approved label instructions. In considering MRLs and variation to MRLs, the APVMA takes into account studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice and dietary exposure. In approving MRLs, the APVMA is satisfied, from dietary exposure assessment, that the levels set are not an undue hazard to human health.

The APVMA has amended the MRL Standard and the changes will have affect the day after the instrument is registered.

Details of the amendment can be found in the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2018 (No. 1).

The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012.

The MRL Standard is accessible via the Federal Register of Legislation website www.legislation.gov.au or the links above.

For further information please contact:

MRL Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4897 Fax: +61 2 6210 4840 Email: [email protected]

Amendments to the APVMA MRL Standard

http://www.comlaw.gov.au/Current/F2012L02501

http://www.comlaw.gov.au/Current/F2012L02501

http://www.legislation.gov.au/

https://edrms/id:A147213/document/versions/[email protected]


Proposal to Amend Schedule 20 of the Australia New Zealand Food Standards Code

In the previous notice on page 48 of APVMA Gazette No. 1, the APVMA gazetted amendments which it has approved to vary maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in the APVMA’s MRL Standard.

Under section 82 of the Food Standards Australia New Zealand Act 1991, the APVMA is proposing to incorporate those variations (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2018 (No. 1)) to MRLs into Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code.

MRLs contained in Schedule 20 provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this means, Schedule 20 permits the sale of treated foods and protects public health and safety by minimising residues in foods consistent with the effective control of pests and diseases.

The APVMA and Food Standards Australia New Zealand (FSANZ) are satisfied, based on dietary exposure assessments and current health standards, that the proposed limits are not harmful to public health.

The agreement between the Australian Government and the New Zealand Government concerning a Joint Food Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.

FSANZ will make a Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO).

The APVMA invites comment on these proposals. Details on how to make a submission appear near the end of this notice, below the details of the proposed amendment.

The APVMA will consider any public comments made in response to this proposal. If the APVMA decides to proceed with the proposal, it will further notify any variations it makes to Schedule 20 in the APVMA Gazette. The variations will take effect as from the date of that subsequent notice.



PROPOSED VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE (16 January 2018) Note: Subsection 82(2) of the Food Standards Australia New Zealand Act 1991 provides that variations to standards are legislative instruments, but are not subject to disallowance or sunsetting.

To commence: on gazettal of variation

[1] The table to section S20–3 in Schedule 20 is varied by

[1.1] inserting in alphabetical order

Agvet chemical: Pydiflumetofen

Permitted residue: Pydiflumetofen

All other foods except animal food commodities

T0.05

Brassica (cole or cabbage) vegetables, head cabbages, flowerhead brassicas

T0.5

Brassica leafy vegetables T10 Celery T15 Cereal grains [except maize and popcorn]

T3

Dried grapes (currants, raisins and sultanas)

T5

Edible offal (mammalian) T*0.01 Eggs T*0.01 Fruiting vegetables, cucurbits T0.5 Fruiting vegetables, other than cucurbits [except mushrooms; sweet corn (corn-on-the-cob)]

T0.7

Grapes T2 Leafy vegetables (except brassica leafy vegetables)

T30

Legume vegetables T0.5 Maize T0.02 Meat (mammalian) T*0.01 Milks T*0.01 Peanut T0.03 Pome fruits T0.2 Popcorn T0.02 Poultry, edible offal of T*0.01 Poultry meat T*0.01 Pulses T0.5 Rape seed (canola) T0.07 Root and tuber vegetables T0.05 Sweet corn (corn-on-the-cob) T*0.01



[1.2] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order

Agvet chemical: Azoxystrobin

Permitted residue: Azoxystrobin

Basil T70

Agvet chemical: Cyantraniliprole

Permitted residue: Cyantraniliprole

Strawberry 0.7

Agvet chemical: Cyhalothrin

Permitted residue: Cyhalothrin, sum of isomers

Hazelnuts T*0.01

Agvet chemical: Fluroxypyr

Permitted residue: Fluroxypyr All other foods except animal food commodities

0.02

Onion, bulb 0.2

Agvet chemical: Imazalil

Permitted residue: Imazalil All other foods except animal food commodities

0.05

Tomato 0.5

Agvet chemical: Oxathiapiprolin

Permitted residue: Oxathiapiprolin Basil T10 Basil, dry T90



INVITATION FOR SUBMISSIONS

Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the proposal to vary Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code. Submissions should be strictly confined to relevant matters that the APVMA must consider (such as public health and safety) which are associated with the occurrence of the proposed residues in foods. Comments received outside these grounds will not be considered by the APVMA. Claims made in submissions should be supported wherever possible by referencing or including relevant studies, research findings, trials, surveys etc. Technical information should be in sufficient detail to allow independent scientific assessment.

Please note that FSANZ will make a SPS notification to the WTO and submissions related to impacts on international trade should be made to FSANZ in response to that notification.

Submissions must be made in writing and should be clearly marked as a ‘submission on the proposed amendment to Schedule 20’ and quote the correct amendment number.

DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (ADST) 13 February 2018

SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL ONLY BE CONSIDERED BY PRIOR ARRANGEMENT

Submissions received after this date will only be considered if agreement for an extension has been given prior to this closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to the submission period.


MRL Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4897 Fax: +61 2 6210 4840 Email: [email protected]




Variations to Schedule 20 of the Australia New Zealand Food Standards Code

The APVMA has previously gazetted particular amendments which it had made to the APVMA MRL Standard and which have been proposed as variations to maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in Schedule 20–Maximum residue limits of the Australia New Zealand Food Standards Code. This notice pertains to proposals (No. 10) gazetted on 3 October 2017 (No. APVMA 20) and (No. 11) gazette on 31 October 2017 (No. APVMA 22).

Submissions have been sought on these proposals and the APVMA has written separately to each person or organisation that made a submission. All matters raised in the submissions have been resolved.

Under subsection 82(1) of the Food Standards Australia New Zealand Act 1991, the APVMA has, by legislative instrument, incorporated these variations to MRLs into Schedule 20. A copy of the Amendment Instrument (No. APVMA 20, 2017) and (No. APVMA 22, 2017) accompanies this notice. For a complete and up-to-date version of Schedule 20, including these amendments together with their Explanatory Statement, please refer to the Federal Register of Legislation website at www.legislation.gov.au

Based on dietary exposure assessments and current health standards, the APVMA and Food Standards Australia and New Zealand (FSANZ) are satisfied that these MRLs are not harmful to public health. MRLs contained in Schedule 20 provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this means, Schedule 20 permits the sale of treated foods and protects public health by minimising residues in foods consistent with the effective control of pests and diseases.

The agreement between the Australian Government and the New Zealand Government concerning a Joint Food Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.

FSANZ made Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO) in relation to these variations and no comment was received in response to that notice.

A copy of these variations have been given to FSANZ.

The variations take effect as from the date of this notice.

This notice is published in accordance with subsection 82(7) of the Food Standards Australia New Zealand Act 1991.


MRL Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604

Phone: +61 2 6210 4897 Fax: +61 2 6210 4840 Email: [email protected]


http://www.legislation.gov.au/



Australia New Zealand Food Standards Code—Schedule 20—Maximum residue limits Variation

Instrument No. APVMA 1, 2018

I, Jason Lutze, Executive Director, Scientific Assessment and Chemical Review and delegate of the Australian Pesticides and Veterinary Medicines Authority, acting in accordance with my powers under subsection 11(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992, make this instrument for the purposes of subsection 82(1) of the Food Standards Australia New Zealand Act 1991.

Jason Lutze Delegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority

Dated this Tenth day of January 2018



Part 1 Preliminary 1 Name of instrument This instrument is the Australia New Zealand Food Standards Code—Schedule

20−maximum residue limits Variation Instrument No. APVMA 1, 2018.

2 Commencement In accordance with subsection 82(8) of the Food Standards Australia New Zealand Act

1991, this instrument commences on the day it is published in the Gazette.

Note: A copy of the variations made by the Amendment Instrument was published in the Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette No. APVMA 1 of 16 January 2018.

3 Object The object of this instrument is for the APVMA to make variations to Schedule

20−Maximum residue limits in the Australia New Zealand Food Standards Code to include or change maximum residue limits pertaining to agricultural and veterinary chemical products.

4 Interpretation In this instrument: — APVMA means the Australian Pesticides and Veterinary Medicines Authority

established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; and

Principal Instrument means Schedule 20−Maximum residue limits in the Australia New Zealand Food Standard Code as defined in Section 4 of the Food Standards Australia New Zealand Act 1991 being the Code published in Gazette No. P 27 on 27 August 1987 together with any amendments of the standards in that Code. Schedule 20 was published in the Food Standards Gazette FSC 96 on Thursday 10 April 2015 and was registered as a legislative instrument on 1 April 2015 (F2015L00468).

Part 2 Variations to Schedule 20—Maximum residue limits

5 Variations to Schedule 20

The Schedule to this instrument sets out the variations made to the Principal Instrument by this instrument.



Schedule

Variations to Schedule 20–Maximum residue limits

[1] The table to section S20–3 in Schedule 20 is varied by

[1.1] omitting from each of the following chemicals, the foods and associated MRLs

Agvet chemical: Chlorantraniliprole

Permitted residue—plant commodities and animal commodities other than milk: Chlorantraniliprole

Permitted residue—milk: Sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliprole Adzuki bean (dry) T0.5 Chick-pea (dry) 0.07 Edible offal (mammalian) [except liver] *0.01 Liver (mammalian) 0.02 Soya bean (dry) 0.07

Agvet chemical: Pyraclostrobin

Permitted residue—commodities of plant origin: Pyraclostrobin

Permitted residue—commodities of animal origin: Sum of pyraclostrobin and metabolites hydrolysed to 1-(4-chloro-phenyl)-1H-pyrazol-3-ol, expressed as pyraclostrobin

Tree nuts [except pistachio nut] *0.01

[1.2] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order

Agvet chemical: Azoxystrobin

Permitted residue: Azoxystrobin Beetroot T0.2

Agvet chemical: Butafenacil

Permitted residue: Butafenacil Pulses *0.01 Rape seed (canola) *0.01





Permitted residue—milk: Sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliprole

Edible offal (mammalian) 0.02 Pulses [except mung bean (dry)] 0.07

Agvet chemical: Dicamba

Permitted residue: Dicamba All other foods except animal food commodities

0.05

Cotton seed T3

Agvet chemical: Etoxazole

Permitted residue: Etoxazole All other foods except animal food commodities

0.05

Avocado T0.1 Agvet chemical: Fludioxonil

Permitted residue—commodities of animal origin: Sum of fludioxonil and oxidisable metabolites, expressed as fludioxonil

Permitted residue—commodities of plant origin: Fludioxonil

Beetroot T0.2 Agvet chemical: Paraquat

Permitted residue: Paraquat cation Oilseed [except cotton seed; peanut] *0.05

Agvet chemical: Pyraclostrobin

Permitted residue—commodities of plant origin: Pyraclostrobin

Permitted residue—commodities of animal origin: Sum of pyraclostrobin and metabolites hydrolysed to 1-(4-chloro-phenyl)-1H-pyrazol-3-ol, expressed as pyraclostrobin

Tree nuts [except pistachio nut and walnut]

*0.01



Walnut T1

Agvet chemical: Saflufenacil

Permitted residue—commodities of plant origin: Sum of saflufenacil, N′-{2-chloro-4-fluoro-5-[1,2,3,6-tetrahydro-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]benzoyl-N-isopropyl sulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino} carbonyl)phenyl]urea, expressed as saflufenacil equivalents

Permitted residue—commodities of animal origin: Saflufenacil

Cereal bran, unprocessed 0.5

Agvet chemical: Sulfoxaflor

Permitted residue: Sulfoxaflor Raspberries, red, black T0.7

Agvet chemical: Tebuconazole

Permitted residue: Tebuconazole Walnuts T*0.05

[1.3] omitting for each of the following chemicals, the maximum residue limit for the food and substituting



Permitted residue—milk: Sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliprole

Milks 0.02

Agvet chemical: Penflufen

Permitted residue: Penflufen

Cotton seed *0.01



Agvet chemical: Saflufenacil

Permitted residue—commodities of plant origin: Sum of saflufenacil, N′-{2-chloro-4-fluoro-5-[1,2,3,6-tetrahydro-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]benzoyl-N-isopropyl sulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino} carbonyl)phenyl]urea, expressed as saflufenacil equivalents

Permitted residue—commodities of animal origin: Saflufenacil Cereal grains 0.2

Agvet chemical: Trifloxystrobin

Permitted residue: Sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)-ethylideneaminooxymethyl] phenyl] acetic acid), expressed as trifloxystrobin equivalents

Cotton seed *0.04


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