Commonwealth of Australia	Gazette	
No. APVMA 25, Tuesday, 15 December 2015
Published by The Australian Pesticides  and Veterinary Medicines Authority	Agricultural and Veterinary Chemicals	
Australian Government
	
Australian Pesticides and Veterinary Medicines Authority
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 2015
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and inquiries concerning reproduction and rights should be addressed to: 
The Manager, Public Affairs and Communications
The Australian Pesticides and Veterinary Medicines Authority
PO Box 6182 
Kingston ACT 2604 
Email: communications@apvma.gov.au 
Website: www.apvma.gov.au.
General Information
The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of the registration of agricultural and veterinary chemicals products and other approvals 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.
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CONTENTS
Agricultural Chemical Products and Approved Labels
Veterinary Chemical Products and Approved Labels
Approved Active Constituents
Licensing of Veterinary Chemical Manufacturers
New Active Constituent Rabbit Haemorrhagic Disease Virus, 08Q712 Strain
New Chemical Product RHDV K5 Containing Rabbit Haemorrhagic Disease Virus, 08Q712 Strain
New Chemical Product Dupont Zorvec Enicade Fungicide Containing Oxathiapiprolin
Amendments to the APVMA MRL Standard
Proposal to amend Schedule 20 of the revised Australia New Zealand Food Standards Code

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.:	101947	
Product name:	ACTA 1080 Dried Meat Wild Dog Bait	
Active constituent/s:	150 mg/kg sodium fluoroacetate	
Applicant name:	Animal Control Technologies (Australia) Pty Ltd	
Applicant ACN:	137 868 449	
Summary of use	For the control of wild dogs	
Date of registration/approval:	25 November 2015	
Product registration no.:	80919	
Label approval no.:	80919/101947	

Application no.:	101951	
Product name:	ACTA 1080 Dried Meat Fox Bait	
Active constituent/s:	80 mg/kg sodium fluoroacetate (1080)	
Applicant name:	Animal Control Technologies (Australia) Pty Ltd	
Applicant ACN:	137 868 449	
Summary of use	For the control of foxes	
Date of registration/approval:	26 November 2015	
Product registration no.:	80924	
Label approval no.:	80924/101951	

Application no.:	103340	
Product name:	EUREKA! Bifenthrin 100 EC Insecticide and Miticide	
Active constituent/s:	100 g/L bifenthrin	
Applicant name:	Eureka! Agresearch Pty Ltd	
Applicant ACN:	086 194 738	
Summary of use	For installing chemical soil barriers, post-construction management of subterranean termites and the control of a large range of other urban pests	
Date of registration/approval:	1 December 2015 	
Product registration no.:	81549	
Label approval no.:	81549/103340	

2.	agricultural Products Based on Existing Active Constituents
Application no.:	56223	
Product name:	Conserve On-Farm Grain Protector	
Active constituent/s:	500 g/L chlorpyrifos-methyl, 30 g/L s-methoprene, 120 g/L spinosad	
Applicant name:	Dow Agrosciences Australia Limited	
Applicant ACN:	003 771 659	
Summary of use	For the control of a broad range of stored product insects in stored cereal grains (excluding rice and malting barley)	
Date of registration/approval:	19 November 2015	
Product registration no.:	67508	
Label approval no.:	67508/56223	

Application no.:	103053	
Product name:	AC Attack Dog 540SL Herbicide	
Active constituent/s:	540 g/L glyphosate present as the potassium salt	
Applicant name:	Axichem Pty Ltd	
Applicant ACN:	131 628 594	
Summary of use	For the control of many annual and perennial weeds	
Date of registration/approval:	24 November 2015	
Product registration no.:	81410	
Label approval no.:	81410/103053	

Application no.:	102321	
Product name:	Fascinate 200 Herbicide	
Active constituent/s:	200 g/L glufosinate-ammonium	
Applicant name:	UPL Australia Limited	
Applicant ACN:	066 391 384	
Summary of use	For the control of non-residual broadleaf and grass weeds in various situations	
Date of registration/approval:	25 November 2015	
Product registration no.:	81099	
Label approval no.:	81099/102321	

Application no.:	103016	
Product name:	Santalum Estate Mosquito Repellent Incense Sandalwood Sticks	
Active constituent/s:	15 g/kg eucalyptus oil 15g/kg citronella oil	
Applicant name:	Mayo Hardware Pty Ltd	
Applicant ACN:	071517176	
Summary of use	For the use of repelling mosquitoes	
Date of registration/approval:	25 November 2015 	
Product registration no.:	81388	
Label approval no.:	81388/103016	

Application no.:	101341	
Product name:	AC Invoke 750 WG Herbicide	
Active constituent/s:	750 g/kg isoxaflutole	
Applicant name:	Axichem Pty Ltd	
Applicant ACN:	131 628 594	
Summary of use	For the control and suppression of various broadleaf weeds and grasses in sugarcane and chickpeas	
Date of registration/approval:	25 November 2015	
Product registration no.:	80655	
Label approval no.:	80655/101341	

Application no.:	103229	
Product name:	ATLAS Fly & Mosquito Coils	
Active constituent/s:	0.5 g/kg citronella oil, 4 g/kg d-allethrin.	
Applicant name:	Pascoe's Pty Ltd	
Applicant ACN:	055 220 463	
Summary of use	For the control of flies and mosquitoes in the home and garden	
Date of registration/approval:	25 November 2015	
Product registration no.:	81506	
Label approval no.:	81506/103229	

Application no.:	102307	
Product name:	Hexanil 250 SL Herbicide	
Active constituent/s:	250 g/L hexazinone	
Applicant name:	Rotam Agrochemical Co., Ltd	
Applicant ACN:	N/A	
Summary of use	For the control of certain broadleaf weeds, perennial and annual grasses, woody weeds in Pinus radiata plantations, pasture situations and commercial and industrial areas and rights of way	
Date of registration/approval:	25 November 2015	
Product registration no.:	81083	
Label approval no.:	81083/102307	

Application no.:	103557	
Product name:	Eureka! Glufosinate 200 SL Herbicide	
Active constituent/s:	200 g/L glufosinate-ammonium	
Applicant name:	Eureka! Agresearch PTY LTD	
Applicant ACN:	086 194 738	
Summary of use	For the control of broadleaf and grass weeds in various situations	
Date of registration/approval:	25 November 2015	
Product registration no.:	81653	
Label approval no.:	81653/103557	

Application no.:	103238	
Product name:	Hovex Crawling Insect Killer Odourless	
Active constituent/s:	0.15 g/kg imiprothrin, 2.79 g/kg permethrin	
Applicant name:	Pascoe's Pty Ltd	
Applicant ACN:	055 220 463	
Summary of use	For the control of cockroaches and other crawling insects	
Date of registration/approval:	26 November 2015	
Product registration no.:	81509	
Label approval no.:	81509/103238	

Application no.:	102816	
Product name:	Zipper 200 Herbicide	
Active constituent/s:	200 g/L glufosinate-ammonium	
Applicant name:	Rotam Agrochemical Co., Ltd	
Applicant ACN:	N/A	
Summary of use	For the control of broadleaf and grass weeds in various situations	
Date of registration/approval:	26 November 2015 	
Product registration no.:	81319	
Label approval no.:	81319/102816	

Application no.:	102817	
Product name:	Rotam Glyphosate 700 Herbicide	
Active constituent/s:	700 g/kg glyphosate	
Applicant name:	Rotam Agrochemical Co., Ltd	
Applicant ACN:	N/A	
Summary of use	For the control of many annual and perennial weeds in certain situations	
Date of registration/approval:	26 November 2015	
Product registration no.:	81320	
Label approval no.:	81320/102817	

Application no.:	101770	
Product name:	JH Termite Barrier	
Active constituent/s:	2.0 g/kg deltamethrin	
Applicant name:	Jinhong Australia Pty Ltd	
Applicant ACN:	163 906 241	
Summary of use	For the protection of buildings and structures from subterranean termites	
Date of registration/approval:	26 November 2015	
Product registration no.:	80846	
Label approval no.:	80846/101770	

Application no.:	100217	
Product name:	Osku Hellas Grape Guards	
Active constituent/s:	735 g/kg sodium metabisulphite	
Applicant name:	Biopac Pty Ltd	
Applicant ACN:	158 624 705	
Summary of use	For the control of botrytis in packaged grapes	
Date of registration/approval:	26 November 2015	
Product registration no.:	80103	
Label approval no.:	80103/100217	

Application no.:	101901	
Product name:	Icasso 240 Herbicide	
Active constituent/s:	240 g/L clethodim	
Applicant name:	Rotam Agrochemical Co., Ltd	
Applicant ACN:	N/A	
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 soy beans	
Date of registration/approval:	26 November 2015 	
Product registration no.:	80906	
Label approval no.:	80906/101901	

Application no.:	102212	
Product name:	Tuken Extra Herbicide	
Active constituent/s:	25 g/L diflufenican, 250 g/L MCPA present as the ethyl hexyl ester	
Applicant name:	Rotam Agrochemical Co., Ltd	
Applicant ACN:	N/A	
Summary of use	For the control of certain broadleaf weeds in winter cereals and clover	
Date of registration/approval:	26 November 2015	
Product registration no.:	81044	
Label approval no.:	81044/102212	

Application no.:	100429	
Product name:	eChem Glyphosate 540 K Herbicide	
Active constituent/s:	540 g/L glyphosate present as the potassium salt	
Applicant name:	Echem (Aust) Pty Limited	
Applicant ACN:	089 133 095	
Summary of use	For the control of many annual and perennial weeds	
Date of registration/approval:	27 November 2015	
Product registration no.:	80222	
Label approval no.:	80222/100429	

Application no.:	102314	
Product name:	Haluron Herbicide	
Active constituent/s:	750 g/kg halosulfuron-methyl	
Applicant name:	Rotam Agrochemical Co., Ltd	
Applicant ACN:	N/A	
Summary of use	For selective post-emergence control of nutgrass in sugarcane and corn/maize and sorghum and for selective post-emergence control of nutgrass and Mullumbimby couch in turf. Also for the control of nutgrass in cotton using shielded sprayers	
Date of registration/approval:	27 November 2015 	
Product registration no.:	81091	
Label approval no.:	81091/102314	

Application no.:	102903	
Product name:	Pest Controller's Own Cockroach Gel	
Active constituent/s:	20 g/kg hydramethylnon	
Applicant name:	Amgrow Pty Ltd	
Applicant ACN:	100 684 786	
Summary of use	For the control of cockroaches, by professional pest control operators, in residential and commercial situations	
Date of registration/approval:	30 November 2015	
Product registration no.:	81363	
Label approval no.:	81363/102903	

Application no.:	103217	
Product name:	Hovex Germgard Crawling Insect Killer High Performance	
Active constituent/s:	0.7 g/kg imiprothrin, 2.0 g/kg cypermethrin	
Applicant name:	Pascoe's Pty Ltd	
Applicant ACN:	055 220 463	
Summary of use	For the control of crawling insects in the home and garden	
Date of registration/approval:	30 November 2015	
Product registration no.:	81500	
Label approval no.:	81500/103217	

Application no.:	103282	
Product name:	Powerforce Algaecide	
Active constituent/s:	150 g/L benzalkonium chloride	
Applicant name:	N & F Pty Ltd	
Applicant ACN:	103 942 427	
Summary of use	For the control of algae in swimming pools	
Date of registration/approval:	30 November 2015	
Product registration no.:	81522	
Label approval no.:	81522/103282	

Application no.:	104059	
Product name:	Relyon Glyphix 450 Herbicide	
Active constituent/s:	450 g/L glyphosate present as the isopropylamine salt	
Applicant name:	Ruralco Holdings Limited	
Applicant ACN:	009 660 879	
Summary of use	For the control of a broad range of annual and perennial weeds	
Date of registration/approval:	30 November 2015 	
Product registration no.:	81791	
Label approval no.:	81791/104059	

Application no.:	103409	
Product name:	Pest Defence Professional Cockroach Gel Bait	
Active constituent/s:	0.5 g/kg abamectin	
Applicant name:	Ensystex Australasia Pty Ltd	
Applicant ACN:	102 221 965	
Summary of use	For the control of cockroaches in commercial, industrial and residential buildings	
Date of registration/approval:	30 November 2015 	
Product registration no.:	81583	
Label approval no.:	81583/103409	

Application no.:	100482	
Product name:	Yates Zero Rapid Gel 1-Hr Action Weedkiller	
Active constituent/s:	20.5 g/L nonanoic acid, 40 g/L glyphosate present as the ammonium salt	
Applicant name:	Duluxgroup (Australia) Pty Ltd	
Applicant ACN:	000 049 427	
Summary of use	For the control of a wide range of annual and perennial weeds and grasses found in home gardens	
Date of registration/approval:	1 December 2015	
Product registration no.:	80255	
Label approval no.:	80255/100482	

Application no.:	102325	
Product name:	Rotam Haloxyfop 520 EC Herbicide	
Active constituent/s:	520 g/L haloxyfop-p present as the haloxyfop-p-methyl ester	
Applicant name:	Rotam Agrochemical Co., Ltd	
Applicant ACN:	N/A	
Summary of use	For the control of a wide range of annual and perennial grass weeds in a wide range of crops	
Date of registration/approval:	1 December 2015 	
Product registration no.:	81102	
Label approval no.:	81102/102325	

Application no.:	103474	
Product name:	Pest Defence Professional Termiticide & Insecticide	
Active constituent/s:	100 g/L bifenthrin	
Applicant name:	Ensystex Australasia Pty Ltd	
Applicant ACN:	102 221 965	
Summary of use	For the protection of structures from subterranean termite damage, the control of various urban insect pests and the control of a range of pests in ornamental plants and turf	
Date of registration/approval:	2 December 2015	
Product registration no.:	81621	
Label approval no.:	81621/103474	

Application no.:	101878	
Product name:	EUREKA! Imazethapyr 700 WG Herbicide	
Active constituent/s:	700 g/kg imazethapyr	
Applicant name:	EUREKA! Agresearch Pty Ltd	
Applicant ACN:	086 194 738	
Summary of use	For the pre-emergence or post-emergence control of certain weeds in Centrosema (Cavalcade), chickpeas, faba beans, field peas, lucerne, mung beans, peanuts, serradella, soybeans and subterranean clover	
Date of registration/approval:	2 December 2015 	
Product registration no.:	80889	
Label approval no.:	80889/101878	

Application no.:	62990	
Product name:	Tybalt 275 EC Herbicide	
Active constituent/s:	25 g/L diflufenican, 250 g/L bromoxynil present as the octanoate.	
Applicant name:	UPL Australia Limited	
Applicant ACN:	066 391 384	
Summary of use	For control of certain broadleaf weeds in winter cereals and pastures	
Date of registration/approval:	2 December 2015	
Product registration no.:	70310	
Label approval no.:	70310/62990	

Application no.:	101957	
Product name:	AC Brushlia 80 Insecticide/Miticide	
Active constituent/s:	80 g/L bifenthrin	
Applicant name:	Axichem Pty Ltd	
Applicant ACN:	131 628 594	
Summary of use	For the control of apple dimpling bug and plague thrips in apples, scab moth and flower thrips in bananas, two spotted mites in pears and several pests in ornamentals	
Date of registration/approval:	2 December 2015	
Product registration no.:	80930	
Label approval no.:	80930/101957	

Application no.:	55846	
Product name:	Preventol TM-Termiticide for Expanded Polystyrene Foam	
Active constituent/s:	970 g/kg imidacloprid	
Applicant name:	Lanxess Pty Ltd	
Applicant ACN:	071 919 116	
Summary of use	For the control of termites infesting construction grade expanded polystyrene foam	
Date of registration/approval:	2 December 2015	
Product registration no.:	67342	
Label approval no.:	67342/55846	

Application no.:	103434	
Product name:	Kenso Agcare Castor 720 SC Fungicide	
Active constituent/s:	720 g/L chlorothalonil	
Applicant name:	Kenso Corporation (M) SDN. BHD	
Applicant ACN:	N/A	
Summary of use	For the control of fungal diseases on almonds, apricots, bananas, carrots, celery, cherries, faba beans, grapes, onions, peaches, peanuts, peas, plums, potatoes, tomatoes, turf and vegetables	
Date of registration/approval:	2 December 2015 	
Product registration no.:	81600	
Label approval no.:	81600/103434	

Application no.:	103550	
Product Name:	Genfarm Fluroxypyr 400 Herbicide	
Active constituent/s:	400 g/L fluroxypyr present as the methylheptyl ester	
Applicant name:	Landmark Operations Limited	
Applicant ACN:	008 743 217	
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	
Date of registration/approval:	3 December 2015 	
Product registration no.:	81650	
Label approval no.:	81650/103550	

Application no.:	103564	
Product name:	Smart Cargo Snail Bait	
Active constituent/s:	15 g/kg metaldehyde	
Applicant name:	Crop Smart Pty Ltd	
Applicant ACN:	093 927 961	
Summary of use	For the control of snails and slugs in many agricultural and horticultural situations	
Date of registration/approval:	3 December 2015 	
Product registration no.:	81654	
Label approval no.:	81654/103564	

Application no.:	104134	
Product name:	Relyon Basher 200 Herbicide	
Active constituent/s:	200 g/L glufosinate-ammonium	
Applicant name:	Ruralco Holdings Limited	
Applicant ACN:	009 660 879	
Summary of use	For the non-residual control of broadleaf and grass weeds in various situations	
Date of registration/approval:	3 December 2015	
Product registration no.:	81832	
Label approval no.:	81832/104134	

Application no.:	101744	
Product name:	Conan 500 Fungicide	
Active constituent/s:	500 g/L chlorothalonil	
Applicant name:	UPL Australia Limited	
Applicant ACN:	066 391 384	
Summary of use	For the control of fungal diseases on fruits, vegetables, turf and other areas	
Date of registration/approval:	3 December 2015	
Product registration no.:	80829	
Label approval no.:	80829/101744	

Application no.:	103784	
Product name:	Atlas 3 In 1 Garden Indoor & Outdoor Surface Spray	
Active constituent/s:	1 g/L esfenvalerate	
Applicant name:	Pascoe's Pty Ltd	
Applicant ACN:	055 220 463	
Summary of use	For protection against flying and crawling insects around the home and garden	
Date of registration/approval:	7 December 2015	
Product registration no.:	81709	
Label approval no.:	81709/103784	

Application no.:	63364	
Product name:	eChem Triasulfuron 750 WG Herbicide	
Active constituent/s:	750 g/kg triasulfuron	
Applicant name:	eChem (Aust) Pty Limited	
Applicant ACN:	089 133 095	
Summary of use	For pre-plant control of annual ryegrass, paradoxa grass and certain broadleaf weeds in wheat and for post-emergent control of wild radish in wheat, oats and barley	
Date of registration/approval:	8 December 2015	
Product registration no.:	70396	
Label approval no.:	70396/63364	

Application no.:	103470	
Product name:	Interspeed 376 Hard Antifouling For Aluminium	
Active constituent/s:	125 g/L copper present as cuprous thiocyanate, 50 g/L zinc pyrithione	
Applicant name:	Akzo Nobel Pty Limited	
Applicant ACN:	000 119 424	
Summary of use	For use on the aluminium hull of vessels for the control of marine growth	
Date of registration/approval:	8 December 2015	
Product registration no.:	81619	
Label approval no.:	81619/103470	

Application no.:	100170	
Product name:	Farmalinx Axy-M Fungicide Seed Treatment	
Active constituent/s:	350 g/L metalaxyl-M	
Applicant name:	Farmalinx Pty Ltd	
Applicant ACN:	134 353 245	
Summary of use	For the control of seedling disease in cotton, peas, lucerne, subterranean clover, carrots, beetroot, maize, sweetcorn and radish	
Date of registration/approval:	8 December 2015	
Product registration no.:	80082	
Label approval no.:	80082/100170	

Application no.:	101647	
Product name:	Brunnings Weed Kill For Buffalo	
Active constituent/s:	6.7 g/L bromoxynil present as the potassium salt, 6.7 g/L MCPA present as the potassium salt	
Applicant name:	Brunnings Garden Products Pty Ltd	
Applicant ACN:	050 655 760	
Summary of use	For the control of bindii, clover, oxalis and other broadleaf weeds in lawns	
Date of registration/approval:	8 December 2015	
Product registration no.:	80788	
Label approval no.:	80788/101647	

3.	Variations of registration 
Application no.:	104764	
Product name:	Virkon S The Broad Spectrum Virucidal Bactericidal Fungicidal Disinfectant	
Active constituent/s:	132 g/kg sodium dodecyl benzene sulphonate, 494 g/kg potassium peroxomonosulphate triple salt, 15 g/kg sodium chloride	
Applicant name:	Lienert Australia Pty. Ltd	
Applicant ACN:	008 293 007	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘ANTEC VIRKON S THE BROAD SPECTRUM VIRUCIDAL BACTERICIDAL FUNGICIDAL DISINFECTANT’ to ‘VIRKON S THE BROAD SPECTRUM VIRUCIDAL BACTERICIDAL FUNGICIDAL DISINFECTANT’	
Date of variation:	3 November 2015	
Product registration no.:	48185	
Label approval no.:	48185/104764	

Application no.:	104764	
Product name:	Virkon S The Broad Spectrum Virucidal Bactericidal Fungicidal Disinfectant	
Active constituent/s:	132 g/kg sodium dodecyl benzene sulphonate, 494 g/kg potassium peroxomonosulfate triple salt, 15 g/kg sodium chloride	
Applicant name:	Lienert Australia Pty. Ltd	
Applicant ACN:	008 293 007	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘ANTEC VIRKON S THE BROAD SPECTRUM VIRUCIDAL BACTERICIDAL FUNGICIDAL DISINFECTANT’ to ‘VIRKON S THE BROAD SPECTRUM VIRUCIDAL BACTERICIDAL FUNGICIDAL DISINFECTANT’	
Date of variation:	3 November 2015	
Product no.:	48185	
Label approval no.:	48185/104764	

Application no.:	104837	
Product name:	Hortico Insect Killer Ready To Spray Tomatoes & Vegetables	
Active constituent/s:	1.2 g/L piperonyl butoxide, 0.3 g/L pyrethrins	
Applicant name:	Duluxgroup (Australia) Pty Ltd	
Applicant ACN:	000 049 427	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘HORTICO INSECT KILLER READY TO USE NATURAL PYRETHRUM’ to ‘HORTICO INSECT KILLER READY TO SPRAY TOMATOES & VEGETABLES’	
Date of variation:	11 November 2015	
Product registration no.:	60782	
Label approval no.:	60782/104837	

Application no.:	104893	
Product name:	Hortico Insect Killer Ready To Spray Fruit & Citrus	
Active constituent/s:	20 g/L petroleum oil	
Applicant name:	Duluxgroup (Australia) Pty Ltd	
Applicant ACN:	000 049 427	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘HORTICO WHITE OIL READY TO USE INSECTICIDE’ to ‘HORTICO INSECT KILLER READY TO SPRAY FRUIT & CITRUS’	
Date of variation:	17 November 2015	
Product registration no.:	67060	
Label approval no.:	67060/104893	

Application no.:	104894	
Product name:	Hortico Insect Killer Concentrate Fruit & Citrus	
Active constituent/s:	825 g/L petroleum oil	
Applicant name:	Duluxgroup (Australia) Pty Ltd	
Applicant ACN:	000 049 427	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘HORTICO WHITE OIL CONCENTRATE INSECTICIDE’ to ‘HORTICO INSECT KILLER CONCENTRATE FRUIT & CITRUS’	
Date of variation:	18 November 2015	
Product registration no.:	67059	
Label approval no.:	67059/104894	

Application no.:	104908	
Product name:	Hortico Bindii Killer Concentrate Lawns	
Active constituent/s:	200 g/L bromoxynil present as the n-octanoyl ester, 200 g/L MCPA present as the ethyl hexyl ester	
Applicant name:	Duluxgroup (Australia) Pty Ltd	
Applicant ACN:	000 049 427	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘HORTICO WEED KILLER FOR BUFFALO LAWNS’ to ‘HORTICO BINDII KILLER CONCENTRATE LAWNS’	
Date of variation:	18 November 2015	
Product registration no.:	67027	
Label approval no.:	67027/104908	

Application no.:	104907	
Product name:	Hortico Bindii Killer Hose On Lawns	
Active constituent/s:	6 g/L bromoxynil present as the potassium salt, 6 g/L MCPA present as the potassium salt	
Applicant name:	Duluxgroup (Australia) Pty Ltd	
Applicant ACN:	000 049 427	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘HORTICO WEED KILLER FOR BUFFALO LAWNS HOSE-ON’ to ‘HORTICO BINDII KILLER HOSE ON LAWNS’	
Date of variation:	18 November 2015	
Product registration no.:	67086	
Label approval no.:	67086/104907	

Application no.:	104916	
Product name:	Protect-Us Verminate Soft Bait Rodenticide	
Active constituent/s:	0.05 g/kg brodifacoum	
Applicant name:	Zapi S.P.A	
Applicant ACN:	N/A	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘PROTECT-US PROFESSIONAL SOFT BAIT RODENTICIDE’ to ‘PROTECT-US VERMINATE SOFT BAIT RODENTICIDE’	
Date of variation:	18 November 2015	
Product no.:	68664	
Label approval no.:	68664/104916	

Application no.:	104943	
Product name:	Zoliar 800 DF Herbicide	
Active constituent/s:	800 g/kg norflurazon	
Applicant name:	Agnova Technologies Pty Ltd	
Applicant ACN:	097 705 158	
Summary of variation:	To remove use on cotton and cotton fallow	
Date of variation:	20 November 2015	
Product registration no.:	63329	
Label approval no.:	63329/104943	

Application no:	102565	
Product name:	Macro Protect 900 WG Herbicide	
Active constituent/s:	900 g/kg atrazine	
Applicant name:	Macrofertil Australia Pty Ltd	
Applicant ACN:	166 370 976	
Summary of variation:	To change the product name from ‘RAVENSDOWN ATRAZINE 900 WG HERBICIDE’ to ‘MACRO PROTECT 900 WG HERBICIDE’	
Date of variation:	25 November 2015	
Product registration no.:	58456	
Label approval no.:	58456/102565	

Application no:	100764	
Product name:	Basta Non-Selective Herbicide	
Active constituent/s:	200 g/L glufosinate-ammonium	
Applicant name:	Bayer Cropscience Pty Ltd	
Applicant ACN:	000 226 022	
Summary of variation:	To extend the use in sugarcane and along fence lines in agricultural areas as
well as the inclusion of two additional Ipomea weed spp	
Date of variation:	25 November 2015	
Product registration no.:	39118	
Label approval no.:	39118/100764	

Application no:	103546	
Product name:	Ultraforce Cockroach Powder	
Active constituent/s:	5 g/kg fipronil	
Applicant name:	Sherwood Chemicals Public Company Limited	
Applicant ACN:	N/A	
Summary of variation:	To include an additional pack size	
Date of variation:	26 November 2015	
Product registration no.:	80043	
Label approval no.:	80043/103546	

Application no:	103296	
Product name:	Saboteur Systemic Insecticide	
Active constituent/s:	400 g/L dimethoate (an anti-cholinesterase compound)	
Applicant name:	Crop Care Australasia Pty Ltd	
Applicant ACN:	061 362 347	
Summary of variation:	To update the label in accordance with the review of dimethoate, and add additional 500 mL and 10 L pack sizes	
Date of variation:	27 November 2015	
Product registration no.:	49600	
Label approval no.:	49600/103296	

Application no:	102802	
Product name:	Nufarm Avadex Xtend Selective Herbicide	
Active constituent/s:	600 g/L triallate	
Applicant name:	Nufarm Australia Limited	
Applicant ACN:	004 377 780	
Summary of variation:	To add uses to control certain weeds in wheat, barley, triticale and canola	
Date of variation:	30 November 2015	
Product registration no.:	67827	
Label approval no.:	67827/102802	

Application no:	102685	
Product name:	Mortein Outdoor Mosquito Coils	
Active constituent/s:	2 g/kg d-allethrin	
Applicant name:	Reckitt Benckiser (Australia) Pty Limited	
Applicant ACN:	003 274 655	
Summary of variation:	To include a new label claim	
Date of variation:	3 December 2015	
Product registration no.:	48228	
Label approval no.:	48228/102685	

Application no.:	101846	
Product name:	Bioguard Spa Chlorinated Concentrate Sanitiser & Oxidiser	
Active constituent/s:	350 g/kg chlorine present as lithium hypochlorite	
Applicant name:	Biolab Australia Pty Ltd	
Applicant ACN:	005 878 017	
Summary of variation:	For the control of algae and bacteria in spas	
Date of variation:	3 December 2015	
Product registration no:	62108	
Label approval no.:	62108/101846	

Application no:	103957	
Product name:	Nufarm Pulse Penetrant	
Active constituent/s:	1000 g/L modified polydimethylsiloxane	
Applicant name:	Nufarm Australia Limited	
Applicant ACN:	004 377 780	
Summary of variation:	To correct active constituent statement and include a pack size range	
Date of variation:	8 December 2015	
Product registration no.:	57279	
Label approval no.:	57279/103957	
4.	label approval
Application no.:	104115	
Product name:	Trithor Termite Protection	
Active constituent/s:	2 g/kg deltamethrin (equivalent to 1 g/m2 deltamethrin)	
Applicant name:	Ensystex Australia Pty Ltd	
Applicant ACN:	096 839 815	
Summary of use: 	To add an additional label name to the product under ‘FLICKGUARD TERMITE PROTECTION SHEET’	
Date of approval:	30 November 2015	
Label approval no.:	59139/104115	

Application no.:	104223	
Product name:	IQ Shock & Swim For Spas & Pools	
Active constituent/s:	372 g/kg chlorine present as sodium dichloroisocyanurate, 100 g/kg sodium tetraborate pentahydrate	
Applicant name:	International Quadratics Pty Ltd	
Applicant ACN:	091 533 167	
Summary of use: 	To add an additional label name to the product under ‘AQUAHEALTH SHOCK & SWIM FOR SPAS AND POOLS’	
Date of approval:	30 November 2015	
Label approval no.:	59801/104223	

Application no.:	100103	
Product name:	Shogun Herbicide	
Active constituent/s:	100 g/L propaquizafop	
Applicant name:	Adama Australia Pty Limited	
Applicant ACN:	050 328 973	
Summary of use: 	To extend the use to include the control of feathertop rhodes grass (chloris virgata)	
Date of approval:	1 December 2015	
Label approval no.:	60764/100103	

Application no.:	103950	
Product name:	Enviro Alkali Wash	
Active constituent/s:	686 g/L sodium hydroxide	
Applicant name:	Envirochem Industries Pty Ltd	
Applicant ACN:	119 218 549	
Summary of use: 	To add an additional label name to the product under ‘TURBOWASH ALKALINE DETERGENT’	
Date of approval:	1 December 2015	
Label approval no.:	64579/103950	

Application no.:	104068	
Product name:	Counts Down Dairy Acid Cleaner	
Active constituent/s:	1306 g/L phosphoric acid	
Applicant name:	Envirochem Industries Pty Ltd	
Applicant ACN:	119 218 549	
Summary of use: 	To add an additional label name to the product under ‘TERMINATOR DAIRY ACID CLEANER’	
Date of approval:	3 December 2015	
Label approval no.:	64626/104068	

Veterinary Chemical Products and Approved Labels 
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1.	Veterinary Products Based on Existing Active Constituents
Application no.:	102016	
Product name:	Bob Martin Since 1892 Flea Rid For Dogs, Cats, Puppies And Kittens Powder	
Active constituent/s:	1.5 g/kg pyrethrins, 10 g/kg piperonyl butoxide	
Applicant name:	Bob Martin (Australia) Pty Ltd	
Applicant ACN:	062 627 883	
Summary of use	For the control of fleas (ctenocephalides spp.), lice (trichodectes canis, heterodoxus spiniger and felicola subrostratus)	
Date of registration/approval:	23 November 2015	
Product registration no.:	80967	
Label approval no.:	80967/102016	

Application no.:	61478	
Product name:	DeLaval Teatsan Plus Extra Concentrated Post Milking Teat Sanitiser With Emollient	
Active constituent/s:	220 g/L propylene glycol, 40 g/L available iodine, 215 g/L glycerine	
Applicant name:	DeLaval Pty Ltd	
Applicant ACN:	004 210 459	
Summary of use	For use as an aid in reducing the spread of mastitis-causing organisms in lactating dairy cows	
Date of registration/approval:	25 November 2015	
Product registration no.:	69709	
Label approval no.:	69709/61478	

Application no.:	100774	
Product name:	CloxaSeal 600	
Active constituent/s:	600 mg cloxacillin (as benzathine salt), 2.6 g bismuth subnitrate	
Applicant name:	Norbrook Laboratories Australia Pty Limited	
Applicant ACN:	080 972 596	
Summary of use	For the treatment of subclinical mastitis caused by organisms sensitive to cloxacillin in dairy cows at drying off	
Date of registration/approval:	3 December 2015	
Product registration no.:	80397	
Label approval no.:	80397/100774	
2.	Listed Registrations
Application no.:	103074	
Product name:	Glucosaguard	
Active constituent/s:	37.4 g/kg glucosamine hydrochloride	
Applicant name:	Holidayz Pty Ltd	
Applicant ACN:	114 201 759	
Summary of use	May improve joint health and function in dogs	
Date of registration/approval:	23 November 2015	
Product registration no.:	81427	
Label approval no.:	81427/103074	
3.	label approval
Application no.:	103661	
Product name:	Bob Martin Since 1892 Flea Rid for Small Dogs and Puppies Spot On	
Active constituent/s:	744 g/L permethrin (25:75::CIS:TRANS)	
Applicant name:	Bob Martin (Australia) Pty Ltd	
Applicant ACN:	062 627 883	
Summary of use: 	To add additional label names to the product under ‘FURRY FACE VETERINARY FLEA & TICK SPOT ON FOR SMALL DOGS & PUPPIES’, ‘PET LOVERS OWN FLEA & TICK SPOT ON FOR SMALL DOGS & PUPPIES’, ‘BOB MARTIN CLEAR FLEA & TICK SPOT ON FOR PUPPIES & SMALL DOGS FROM 12 WEEKS’, ‘BOB MARTIN VETCARE FLEA & TICK SPOT ON FOR PUPPIES & SMALL DOGS FROM 12 WEEKS’, ‘VETZYME FLEA & TICK SPOT ON FOR PUPPIES & SMALL DOGS FROM 12 WEEKS’, ‘PESTROY FLEA & TICK SPOT ON FOR PUPPIES & SMALL DOGS FROM 12 WEEKS’	
Date of approval:	2 December 2015	
Label approval no.:	53952/103661	

Application no.:	103672	
Product name:	Bob Martin Since 1892 Flea Rid for Dogs, Cats, Puppies and Kittens Shampoo	
Active constituent/s:	10 g/L piperonyl butoxide, 1 g/L pyrethrins	
Applicant name:	Bob Martin (Australia) Pty Ltd	
Applicant ACN:	062 627 883	
Summary of use: 	To add an additional label name to the product under ‘FURRY FACE VETERINARY FLEA RID SHAMPOO FOR DOGS, CATS, PUPPIES & KITTENS’, ‘PET LOVERS OWN FLEA RID SHAMPOO FOR DOGS, CATS, PUPPIES & KITTENS’, ‘BOB MARTIN CLEAR FLEA & TICK SHAMPOO’, ‘BOB MARTIN VETCARE FLEA & TICK SHAMPOO’, ‘VETZYME FLEA & TICK SHAMPOO’, ‘PESTROY FLEA & TICK SHAMPOO’	
Date of approval:	2 December 2015	
Label approval no.:	65521/103672	

Approved Active Constituents
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of the approval of the following active constituents, with effect from the dates shown.
1.	active consitutent
Application no.:	101768	
Active constituent/s:	Diflufenican	
Applicant name:	Alpha Crop Protection Pty Ltd	
Applicant ACN:	165 653 047	
Summary of use:	For use in agricultural chemical products	
Date of approval:	2 December 2015	
Approval no.:	80845	

Application no.:	102274	
Active constituent/s:	Tebuconazole	
Applicant name:	Adama Australia Pty Limited	
Applicant ACN:	050 328 973	
Summary of use:	For use in agricultural chemical products	
Date of approval:	2 December 2015	
Approval no.:	81074	

Application no.:	62718	
Active constituent/s:	Imazamox	
Applicant name:	Sinochem Agro Co., Ltd	
Applicant ACN:	N/A	
Summary of use:	For use in agricultural chemical products	
Date of approval:	3 December 2015	
Approval no.:	70203	

Application no.:	102327	
Active constituent/s:	Pyriproxyfen	
Applicant name:	Tagros Chemicals India Limited	
Applicant ACN:	N/A	
Summary of use:	For use in agricultural chemical products	
Date of approval:	8 December 2015	
Approval no.:	81104	

Licensing of Veterinary Chemical Manufacturers
Pursuant to Part 8 of the Agricultural and Veterinary Chemical Codes scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has taken action, with respect to the licensing of the following veterinary chemical manufacturers, with effect from the dates shown.
For a comprehensive listing of all licensed manufacturers please see the APVMA’s website www.apvma.gov.au.
1.	NEW LICENCES
The APVMA has issued the following licences under subsection 123(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].
Arthropharm Pty Ltd	LICENCE NO: 1107	
ACN: 003 261 907
111 Bronte Road
BONDI JUNCTION NSW 2022	Product Types:*	
	•	Category 1:  Sterile products for injection
•	Category 2:  Capsules	
	Step(s) of Manufacture: Quality Assurance (QA) of raw materials, formulation including blending, aseptic filling, filling, packaging, secondary packaging, labelling, sterilisation (heat, filtration), microbiological reduction treatment (heat, filtration), analysis and testing (physical, chemical, endotoxin, microbiological), storage and release for supply.	
	Licence Issued: 23 October 2015	

2.	CHANGES TO EXISTING LICENCES
The APVMA has issued the following licences under subsection 123(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code
The commonwealth of australia acting through the commonwealth scientific and industrial research organisation	LICENCE NO: 1110	
ABN: 41 687 119 230
CSIRO Manufacturing Flagship
CSIRO Tissue Culture Facility
Building 205B
Bayview Avenue
CLAYTON VIC 3168	Product Types: *	
	•	Category 1: Immunobiologicals (snake antivenom and tetanus antitoxin)	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, aseptic filling, packaging, labelling, sterilisation (filtration), microbiological reduction treatment (heat and filtration), analysis and testing (physical, microbiological and endotoxin) and storage.	
	Amended Licence Issued: 15 October 2015 	

Australian laboratory services pty. ltd.	LICENCE NO: 6179	
ACN: 009 936 029
Unit 10
2–8 South Street
RYDALMERE NSW 2116	Product Types: *	
	•	Category 6: Single step manufacture	
	Step(s) of Manufacture: Analysis and testing (physical, chemical and microbiological)	
	Amended Licence Issued: 20 October 2015 	

pfizer australia pty ltd	LICENCE NO: 2063	
ACN: 008 422 348
38–42 Wharf Road
WEST RYDE NSW 2114	Product Types: *	
	•	Category 2: Tablets, capsules, creams/lotions, ointments, pastes, powders and suspensions (semi-solid).	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, strip, blister or sachet packaging, tableting, tablet coating, analysis and testing (physical, chemical, antibiotic assay, microbiological), storage and release for supply.	
	Amended Licence Issued: 21 October 2015	

Vetafarm Pty. Ltd.	LICENCE NO: 2010	
ACN:  059 895 153
3 Bye Street
WAGGA WAGGA NSW 2650	Product Types: *	
	•	Category 2: Tablets, powders, liquids and gels
•	Category 3: Liquids	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, granulation, dry milling, packaging, labelling, tableting, analysis and testing (chemical and physical), storage and release for supply.	
	Amended Licence Issued: 21 October 2015	

pharmasynth pty ltd	LICENCE NO: 1086	
ACN: 074 656 509
2806 Ipswich Road
DARRA QLD 4076	Product Types: *	
	•	Category 1: vaccines	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, cell propagation, virus cultivation, filling, packaging, labelling, sterilisation (heat and filtration), microbiological reduction treatment (heat, filtration and chemical), analysis and testing (physical), release for supply, storage.	
	Amended Licence Issued: 2 November  2015 	

mega lifesciences (Australia) pty ltd	LICENCE NO: 4095	
ACN:  076 713 392
60 National Avenue
PAKENHAM, VIC 3810
	Product Types: *	
	•	Category 4: Premixes and supplements	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, dry milling, packaging, labelling, storage and release for supply. 	
	Amended Licence Issued: 3 November 2015	

ZOETIS Australia RESEARCH AND MANUFACTURING Pty ltd	LICENCE NO: 1098	
ACN: 158 433 053
45 Poplar Road
PARKVILLE VIC 3052  	Product Types: *	
	•	Category 1: Immunobiologicals and sterile products	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, bacterial fermentation, virus cultivation, peptide conjugation, propagation of genetically modified mammalian cells, extraction and purification of viral protein, formulation including blending, aseptic filling, filling, packaging, labelling, sterilisation (heat, filtration), microbiological reduction treatment (heat, filtration), freeze-drying, storage and release for supply.	
	Amended Licence Issued: 3 November 2015 	

Pharmapak Technologies Pty Ltd	LICENCE NO: 6107	
ACN:  093 794 104
7 Inman Road 
DEE WHY NSW 2099	Product Types: *	
	•	Category 6: Single step manufacture	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, filling, packaging, labelling, strip, blister and sachet packaging, storage and release for supply.	
	Amended Licence Issued: 4 November 2015	

western australian agriculturE authority	LICENCE NO: 1091	
ABN:  86 611 226 341
Animal Health Laboratories
Department of Agriculture & Food
444 Albany Highway
ALBANY WA 6330	Product Types: *	
	•	Category 1: Immunobiologicals	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, collection and preparation of mature nematodes, antigen extraction, formulation including blending, sterilisation (heat, filtration), microbiological reduction treatment (filtration), aseptic filling, packaging, labelling, analysis and testing (physical, chemical, immunobiological), storage and release for supply.	
	Amended Licence Issued: 5 November 2015 	

blackmores Limited	LICENCE NO: 6186	
ACN:  009 713 437
20 Jubilee Avenue
WARRIEWOOD NSW 2102	Product Types:*	
	•	Category 6: Single step manufacture	
	Step(s) of Manufacture: Packaging, labelling and release for supply.	
	Amended Licence Issued: 10 November 2015	

Propharma Australia Pty. Ltd.	LICENCE NO: 4025	
ACN: 004 983 984
6 Elliot Road
DANDENONG VIC 3175	Product Types: *	
	•	Category 4: Premixes and supplements	
	Step(s) of Manufacture: Quality assurance (QA) raw materials, formulation including blending, dry milling, filling, packaging, labelling, analysis and testing (physical), storage and release for supply	
	Amended Licence Issued: 25 November 2015	
3.	LICENCE CANCELLATIONS
The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].
Ausrichter pty ltd	LICENCE NO: 6012	
ACN: 000 908 529
Camperdown Mews
2/21 Chester Street
CAMPERDOWN NSW 2050	Date Cancelled: 23 October 2015	

Department of Agriculture (WA)	LICENCE NO: 6079	
ABN: 18 951 343 745
3 Baron-Hay Court
SOUTH PERTH WA 6151	Date Cancelled: 2 November 2015	

AZPA Pharmaceuticals Pty Ltd	LICENCE NO: 2224	
ACN: 156 127 230
48 Translink Road
Keilor Park VIC 3042	Date Cancelled: 19 November 2015	

Integria healthcare (Ballina) Pty Ltd	LICENCE NO: 3009	
ACN: 002 833 141
Pacific Highway
Ballina NSW 2478	Date Cancelled: 19 November 2015	

Dermcare-vet pty ltd	LICENCE NO: 1052	
ACN: 010 280 010
22 Aranda Street
Springwood QLD 4127	Date Cancelled: 19 November 2015	

CSL limited	LICENCE NO: 1030	
ACN: 051 588 348
45 Poplar Road
Parkville VIC 3052	Date Cancelled: 23 November 2015	

Rebop Holdings Pty Ltd, trading as western Stock Distributors	LICENCE NO: 2033	
ACN: 009 372 525
Koojan Avenue
South Guildford WA 6055	Date Cancelled: 23 November 2015	

THE University of melbourne veterinary hospital	LICENCE NO: 1078	
ABN: 75 360 513 347
250 Princess Highway
Werribee VIC 3030	Date Cancelled: 23 November 2015	

Sunnyfield	LICENCE NO: 6170	
ACN: 000 415 127
5 Kurrajong Road
St Marys NSW 2760	Date Cancelled: 25 November 2015	

Annex Holdings PTY LTD	LICENCE NO: 6141	
ACN: 080 349 828
114 Fairbank Road
Clayton South VIC 3169	Date Cancelled: 25 November 2015	

Agrisearch Analytical pty limited	LICENCE NO: 6106	
ACN: 094 752 959
Level 1, 48 Victoria Road
Rozelle NSW 2039	Date Cancelled: 25 November 2015	

4.	LICENCE SUSPENSIONS
The APVMA has suspended the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].
Modern ark Pty Ltd	LICENCE NO: 2215	
ACN: 104 514 801
10 Activity Street
WARWICK QLD 4370	Date Suspended: 1 October 2015 (to 31 December 2015)	

Australian Animal Blood Bank Pty Ltd	LICENCE NO: 1101	
ACN: 140 128 990
50 Wills Road
LONG POINT NSW 2564	Date Suspended: 15 November 2015 (to 15 February 2016)	
5.	REVOCATION OF LICENCE CANCELLATION
The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].
Nil
6.	REVOCATION OF LICENCE SUSPENSION
The APVMA has revoked the suspension of the following licences under subsection 127(7) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].
Nil
APVMA Contact
Manufacturing Quality and Licensing Section
Legal and Compliance Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4899
Fax:	+61 2 6210 4813
Email:	mls@apvma.gov.au 
New Active Constituent Rabbit Haemorrhagic Disease Virus, 08Q712 Strain
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for approval of a new active constituent, Rabbit haemorrhagic disease virus, 08Q712 strain.
Common name:	Rabbit haemorrhagic disease virus, 08Q712 strain	
IUPAC name:	Not applicable	
CAS name:	Not applicable 	
CAS registry number:	Not applicable	
Manufacturer’s code:	Rabbit haemorrhagic disease virus, K5 variant	
Minimum purity:	Not applicable 	
Molecular formula:	Not applicable	
Molecular weight:	Not applicable	
Structure:	RHDV is an RNA virus which has been measured in the range of 28–42 nm in diameter	
Chemical family:	RHDV is a naturally occurring RNA based Lagovirus (Family Caliciviridae)	
Mode of action:	Not applicable	
Summary of the APVMA’s Evaluation of Rabbit haemorrhagic disease virus, 08Q712 strain Active Constituent
The APVMA has evaluated the chemistry aspects (manufacturing process, quality control procedures, batch analysis results, stability, analytical methods, physico-chemical properties, formulation process, and packaging) of both active, Rabbit haemorrhagic disease virus, 08Q712 strain, and product, RHDV K5, concurrently and found them to be acceptable.
Other compounds of toxicological significance are not expected to occur in Rabbit haemorrhagic disease virus, 08Q712 strain active constituent.
The Office of Chemical Safety (OCS) has completed a toxicological evaluation of Rabbit haemorrhagic disease virus, 08Q712 strain.
No Acceptable Daily Intake (ADI) or Acute Reference Dose (ARfD) for Rabbit haemorrhagic disease virus, 08Q712 strain is required since the proposed product RHDV K5 containing Rabbit haemorrhagic disease virus, 08Q712 strain is proposed for use as a biological control for wild rabbits and has no apparent toxicological concerns for humans.
Rabbit haemorrhagic disease virus, 08Q712 strain, an antigenic variant of the already registered Rabbit Calicivirus active constituent (Rabbit haemorrhagic disease virus, v351 strain), has no apparent toxicological concerns. Therefore, placement in a poisons schedule is not recommended.
The OCS has indicated that there are no objections on toxicological grounds to the approval of the active constituent Rabbit haemorrhagic disease virus, 08Q712 strain.
The APVMA accepts the findings and recommendations of its advisers on these criteria.
The APVMA is satisfied that the proposed manufacture and use of Rabbit haemorrhagic disease virus, 08Q712 strain would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use.
Making a Submission
In accordance with section 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether Rabbit haemorrhagic disease virus, 08Q712 strain should be approved. Submissions should relate only to matters that are considered in determining whether the safety criteria set out in section 5A of the Agvet Code have been met. Submissions should state the grounds on which they are based.
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.
When making a submission please include:
•	contact name
•	company or group name (if relevant)
•	email or postal address
•	the date you made the submission.
All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially. 
Written submissions should be addressed in writing to: 
Director of Chemistry 
Scientific Assessment and Chemical Review Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4936
Fax:	+61 2 6210 4840
Email:	chemistry@apvma.gov.au 

New Chemical Product RHDV K5 Containing Rabbit Haemorrhagic Disease Virus, 08Q712 Strain
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for registration of a new product containing a new active constituent, Rabbit haemorrhagic disease virus, 08Q712 strain. The product is RHDV K5.
Particulars of The Application
Proposed product name:	RHDV K5 	
Applicant company:	NSW Department of Primary Industries	
Name of active constituent:	Rabbit haemorrhagic disease virus, 08Q712 strain	
Signal heading:	Not applicable	
Summary of proposed use:	For the infection of wild European rabbits (Oryctolagus cuniculus) in accordance with directions of the appropriate State or Territory government authority	
Pack sizes:	10 mL  	
Withholding period:	Not applicable	
Summary of the APVMA’s evaluation of RHDV K5 in accordance with THE REQUIREMENTS OF SECTION 14(1)(C) OF the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994
1.	The APVMA has evaluated the application and its assessment in relation to whether the safety criteria have been met in accordance with the definition set out in section 5A of the Agvet Code, and proposes to determine that:
(i)	The APVMA is satisfied that the proposed use of RHDV K5 containing the active constituent Rabbit haemorrhagic disease virus, 08Q712 strain would not be an undue hazard to the safety of people exposed to it during its handling and use.
The Office of Chemical Safety (OCS) in the Department of Health has conducted a risk assessment on the product and concluded it can be used safely.
The product is a lyophilised (freeze-dried) formulation of at least 30,000 ID50 units Rabbit haemorrhagic disease virus, 08Q712 strain contained in a 10 mL multi use glass vial. This lyophilised formulation must be reconstituted in distilled water prior to use. Once reconstituted, it will be used to either inject live rabbits, or prepare a carrot or oat bait and fed to live rabbits, in order to infect them with Rabbit haemorrhagic disease virus, 08Q712 strain. Infected rabbits will then spread Rabbit haemorrhagic disease virus, 08Q712 strain to other rabbits by direct contact or indirectly through faeces and other vectors such as insects. This should lead to a local epizootic of rabbit haemorrhagic disease (RHD) which causes mortality and is claimed to reduce overall rabbit numbers across Australia.
Workers may be exposed to the product when opening the vials, mixing and diluting the virus to prepare the end use product, product application via injection or mixed feed and cleaning up spills and equipment. The main route of exposure to the product will be dermal, although accidental self-injection or ocular exposure may also occur. Based on the outcomes of the risk assessment, First Aid Instructions and Safety Directions have been recommended for inclusion on the product labels.
Based on an assessment of worker health and safety, it was considered that there should be no adverse effects on human health from the use of RHDV K5 when used in accordance with the label directions.
(ii)	The APVMA is satisfied that the proposed use of RHDV K5 will not be an undue hazard to the safety of people using anything containing its residues as the product is proposed for use as a biological control for wild rabbits and has no apparent toxicological concerns for humans.
(iii)	The APVMA is satisfied that the proposed use of RHDV K5 containing the active constituent Rabbit haemorrhagic disease virus, 08Q712 strain is not likely to be harmful to human beings if used according to the product label directions.
The product is a lyophilised (freeze-dried) formulation of at least 30,000 ID50 units Rabbit haemorrhagic disease virus, 08Q712 strain contained in a 10 mL multi use glass vial. This lyophilised formulation must be reconstituted in distilled water prior to use. Once reconstituted, it will be used to either inject live rabbits, or prepare a carrot or oat bait and fed to live rabbits, in order to infect them with Rabbit haemorrhagic disease virus, 08Q712 strain. Infected rabbits will then spread Rabbit haemorrhagic disease virus, 08Q712 strain to other rabbits by direct contact or indirectly through faeces and other vectors such as insects. This should lead to a local epizootic of rabbit haemorrhagic disease (RHD) which causes mortality and is claimed to reduce overall rabbit numbers across Australia.
The product RHDV K5 is not intended for home use and therefore exposure to members of the public via normal use of the product is not expected to occur. RHDV K5 is proposed for use as a biological control for wild rabbits and has no apparent toxicological concerns for humans.
The APVMA has considered the findings of the Department of Health and accepts these conclusions. Based on an assessment of the toxicology, it was considered that there should be no adverse effects on human health from the use of RHDV K5 when used in accordance with their label directions.
(iv)	The APVMA is satisfied that the proposed use of the new product RHDV K5 containing the active constituent Rabbit haemorrhagic disease virus, 08Q712 strain, would not be likely to have an unintended effect that is harmful to animals, plants or things or the environment.
Data provided in support of the proposed use have been assessed and it is concluded that the risks to the environment from this use are acceptable.
The Rabbit haemorrhagic disease virus, 08Q712 strain, is a G6 strain belonging to Clade 1/D, also known as a Rabbit haemorrhagic disease virus antigenic variant (RHDVa) strain. It is considered to be closely enough related with maximum nucleotide and amino acid differences of 10% and 6%, respectively to the currently registered Rabbit haemorrhagic disease virus, Czech v351 (RHDV-Czech v351) strain, that it can be expected to have an equivalent environment risk profile to that existing strain. Despite genetic and antigenic variability, the variants are the same lagovirus type (RHDV) but belong to differing subtypes (‘classical’ RHDV and RHDVa). Importantly, Rabbit haemorrhagic disease virus, 08Q712 strain is not an RHDV2 strain which have been shown to overcome RHDV antibodies and cause mortality in both rabbits and hares.
As such, the registered product containing RHDV-Czech v351 is a suitable reference product to assist in the characterisation of environmental fate, ecotoxicity and risk of proposed product. However, consideration of Rabbit haemorrhagic disease virus, 08Q712 strain with respect to its fate in the environment in relation to host resistance and potential for direct and indirect effects on non-target plants and animals has been undertaken by APVMA’s advisor.
Environmental effects of RHDV can be divided into direct and non-direct effects. Direct effects include pathogenicity, infectivity, and exposure. Indirect effects include prey switching/shifting, prey loss and effects on native predators, and risk of increase in woody weeds. It is considered that the risk of RHDV to non-target organisms is low because:
•	there are no substantiated reports of epidemiologically relevant infectivity of RHDV in animal species other than rabbits
•	there is limited increased predation on populations of native animals by rabbit predators following decline in rabbit numbers (prey switching)
•	there is no evidence of adverse impacts on vegetation, e.g. due to loss of rabbit herbivory on woody weeds
•	the release of RHDV-Czech v351 strain has resulted in no apparent environmental risk.
The RHDV-Czech v351 and the Rabbit haemorrhagic disease virus, 08Q712 strain are likely to contact each other due to co-infection in rabbit populations as such viral recombination may pose a risk to the environment; however, due to the low likelihood of this recombination causing a potential increase in host range the environmental risk remains low. 
An RHDV vaccine, with an existing APVMA registration, is available for the protection of valuable (non-pest) rabbits that are farmed or kept as domestic pets. This vaccine is protective, when used in accordance with its directions for use, against the RHDV-Czech v351 strain and the Rabbit haemorrhagic disease virus, 08Q712 strain.
The risk assessment determined that RHDV K5 is unlikely to pose an environmental risk under the proposed use pattern. The APVMA has considered the findings of their advisor and accepts these conclusions.
2.	The APVMA has evaluated the applications and in its assessment in relation to whether the efficacy criteria have been met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:
(i)	In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials supporting the efficacy of RHDV K5 adequately demonstrates that if used according to the product label directions, the product is effective for its proposed use.
3.	The APVMA has evaluated the applications and in its assessment in relation to whether the trade criteria have been met in accordance with the definition set out in section 5C of the Agvet Code, and proposes to determine that:
(i)	The APVMA is satisfied that the proposed use of RHDV K5 would not adversely affect trade between Australia and places outside Australia as the product is not for use in animals producing any major Australian export commodities.
FuRther Information
A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Public Consultation’ page, apvma.gov.au/news-and-publications/public-consultations  or by contacting the evaluator listed below.

Making a Submission
In accordance with section 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether RHDV K5 should be registered. Submissions should relate only to matters that are required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have been met. Submissions should state the grounds on which they are based. 
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post. 
Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and in determining appropriate conditions of registration and product labelling.
When making a submission please include:
•	contact name
•	company or group name (if relevant)
•	email or postal address
•	the date you made the submission.
All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially.
Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for registration should be addressed in writing to: 
Case Management and Administration Unit 
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4701
Fax:	+61 2 6210 4721
Email:	enquiries@apvma.gov.au 
New Chemical Product Dupont Zorvec Enicade Fungicide Containing Oxathiapiprolin
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for registration of a new product containing a new active constituent, oxathiapiprolin. The product is DUPONT ZORVEC ENICADE FUNGICIDE.
Particulars of The Application
Proposed product name:	DUPONT ZORVEC ENICADE FUNGICIDE	
Applicant company:	DU PONT (AUSTRALIA) PTY LTD	
Name of active constituent:	Oxathiapiprolin (100 g/L)	
Signal heading:	Not applicable (proposed)	
Summary of proposed use:	For the control of certain fungal disease species in oilseed poppies and vegetable crops as per the Directions for Use	
Pack sizes:	1 L and 5 L 	
Withholding period:	BRASSICA VEGETABLES: NOT REQUIRED WHEN USED AS DIRECTED
CUCURBIT VEGETABLES: DO NOT HARVEST FOR 1 DAY AFTER APPLICATION
BRASSICA LEAFY VEGETABLES, LEAFY VEGETABLES: DO NOT HARVEST FOR 3 DAYS AFTER APPLICATION
BULB VEGETABLES: DO NOT HARVEST FOR 10 DAYS AFTER APPLICATION
POPPIES: DO NOT HARVEST FOR 6 WEEKS AFTER APPLICATION	
Summary of the APVMA’s evaluation of DUPONT ZORVEC ENICADE FUNGICIDE in accordance with THE REQUIREMENTS OF SECTION 14(1)(C) OF the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994
1.	The APVMA has evaluated the application and its assessment in relation to whether the safety criteria have been met in accordance with the definition set out in section 5A of the Agvet Code, and proposes to determine that:
(i)	The APVMA is satisfied that the proposed use of DUPONT ZORVEC ENICADE FUNGICIDE containing the active constituent oxathiapiprolin would not be an undue hazard to the safety of people exposed to it during its handling and use.
The Office of Chemical Safety (OCS) in the Department of Health has conducted a risk assessment on the product and concluded it can be used safely.
DUPONT ZORVEC ENICADE FUNGICIDE is proposed for use in bulb, brassica, cucurbit and leafy vegetables and poppies as a foliar fungicide for control of downy mildew at use rates up to 350 mL product/ha by ground boom equipment.
Based on the proposed use patterns the likely exposure for users is expected to be short to long term. The main routes of exposure are likely to be dermal and inhalational with possible accidental ocular exposure. Workers may re-enter treated crops to scout for disease control, weeding, irrigation and harvesting.
In the absence of exposure data for the proposed mode of application, the Pesticide Handler Exposure Database (PHED) Surrogate Exposure Guide (1998) was used to estimate exposure. Dislodgeable Foliar Residue (DFR) data provided was used to refine the post-application exposure estimates. 
The risk assessment concluded that exposure to the product during mixing, loading ground boom application were determined to be at acceptable levels without the use of personal protective equipment (PPE). However based on the hazard profile of the product, PPE is required during use (mixing/loading) of the product. Based on the outcomes of the risk assessment, First Aid Instructions and Safety Directions have been recommended for inclusion on the product label.
Based on an assessment of worker health and safety, it was considered that there should be no adverse effects on human health from the use of DUPONT ZORVEC ENICADE FUNGICIDE when used in accordance with the label directions.
(ii)	The APVMA is satisfied that the proposed use of DUPONT ZORVEC ENICADE FUNGICIDE will not be an undue hazard to the safety of people using anything containing its residues.
The chronic dietary intake risk for oxathiapiprolin has been assessed. The Acceptable Daily Intake (ADI) for oxathiapiprolin is 4.1 mg/kg bw/day, based upon a No Observable Adverse Effect Level (NOAEL) of 411 mg/kg bw/day and a 100-fold safety factor. The National Estimated Daily Intake (NEDI) calculation is a conservative estimate of dietary exposure to chemical residues in food. The NEDI for oxathiapiprolin, is equivalent to <0.1% of the ADI. HARVEST Modelling (software used by Food Standards Australia and New Zealand) of chronic dietary exposure is also performed on new chemicals. The HARVEST model estimated the chronic dietary exposure of oxathiapiprolin as <0.1% of the ADI for the general population. 
An acute reference dose (ARfD) has not been established for oxathiapiprolin due to the lack of an identified acute toxicological hazard.
It is concluded that the dietary exposure to oxathiapiprolin is low and the risk from residues in food is acceptable when DUPONT ZORVEC ENICADE FUNGICIDE is used according to label directions.
(iii)	The APVMA is satisfied that the proposed use of DUPONT ZORVEC ENICADE FUNGICIDE containing the active constituent oxathiapiprolin is not likely to be harmful to human beings if used according to the product label directions.
DUPONT ZORVEC ENICADE FUNGICIDE is intended for use in bulb, brassica, cucurbit and leafy vegetables and poppies as a protectant fungicide against downy mildew.
The data package provided in the present submission was evaluated as part of a Global Joint Review. It included studies on toxicokinetics/metabolism, dermal absorption, acute (both active constituent and product), short-term, subchronic, chronic and carcinogenicity, reproduction and developmental studies, as well as studies on neurotoxicity, immunotoxicity and genotoxicity. Genotoxicity studies were also conducted on a number of metabolites and impurities of oxathiapiprolin. The studies were conducted to Good Laboratory Practice (GLP), Quality Assurance (QA) and Organisation for Economic Co-operation and Development (OECD)-equivalent guidelines. These studies were considered reliable to establish the toxicity profile of oxathiapiprolin and DUPONT ZORVEC ENICADE FUNGICIDE.
The Advisory Committee on Chemicals Scheduling (ACCS) have considered the OCS recommendations to the Chemicals Scheduling Delegate of the Department of Health that consideration be given to a listing in Appendix B of the Poisons Standard for Oxathiapiprolin. The Delegate’s interim decision is expected to be published in February 2016 at the TGA website.
In toxicokinetics studies, oxathiapiprolin was moderately (up to 50%) and rapidly absorbed at low doses, widely distributed throughout the body and moderately metabolised. Oxathiapiprolin was rapidly excreted via the faecal pathway. There were no marked sex differences in the absorption, distribution, metabolism, and excretion (ADME) of oxathiapiprolin regardless of the different positions of radio-label. Excretion was relatively rapid and extensive, with the majority of the administered dose excreted, predominantly as unchanged parent compound, within 24 hours and virtually complete by 48 hours, indicating a low probability of bioaccumulation of the parent compound or metabolites.
In acute toxicity studies in rats, oxathiapiprolin was of low acute oral, dermal and inhalational toxicity in rats. Oxathiapiprolin was a non-irritant to the skin and eye in rabbits, and was not a skin sensitiser in guinea pigs (Maximization method).
Repeat dose studies were unremarkable with no toxicologically relevant effects seen at the highest administered doses, with the exception of the two generation reproduction study in rat. In the reproduction study there was a slight but significant delay in preputial separation in male pups of both generations at the highest dose.
Based on the findings of the toxicological studies evaluated, the product DUPONT ZORVEC ENICADE FUNGICIDE was of low acute oral, dermal and inhalational toxicity in rats, was a slight skin irritant but not an eye irritant in rabbits, and was a skin sensitiser in guinea pigs (Maximization method).
The acute toxicology data evaluated in this assessment, along with evaluated information on the repeat-dose toxicology of the active constituent were relied on by the OCS to establish a hazard profile for the proposed product.
After consideration of the hazards associated with the active constituent and the proposed product, along with the exposure and risks expected with use of the proposed product, it was considered that the approval of the active constituent oxathiapiprolin, and the proposed use of DUPONT ZORVEC ENICADE FUNGICIDE will not be an undue health hazard to humans.
The APVMA has considered the findings of the Department of Health and accepts these conclusions. Based on an assessment of the toxicology, it was considered that there should be no adverse effects on human health from the use of DUPONT ZORVEC ENICADE FUNGICIDE when used in accordance with its label directions.
(iv)	The APVMA is satisfied that the proposed use of the new product DUPONT ZORVEC ENICADE FUNGICIDE containing the active constituent oxathiapiprolin, would not be likely to have an unintended effect that is harmful to animals, plants or things or the environment.
The Department of the Environment (DotE) has assessed fate and effects data in support of the proposed use and has concluded that the risks to the environment from this use are acceptable. 
Oxathiapiprolin is slightly soluble in water and stable to hydrolysis. It is moderately degradable by photolysis in water. Under aerobic and anaerobic conditions, oxathiapiprolin partitions from water to sediment, where it is slightly/very slightly degradable. Oxathiapiprolin is readily to slightly/very slightly degradable by biotic processes in soil under aerobic, anaerobic and field conditions. The main metabolites are slightly/fairly degradable in aerobic soils but readily degradable in aquatic sediment systems. The mobility of oxathiapiprolin ranges from slight to immobile in soil while its metabolites range from being very highly mobile to immobile. Oxathiapiprolin does not bioaccumulate in fish.
Oxathiapiprolin is practically non-toxic to mammals acutely and at worst is moderately toxic to birds with dietary exposure but some reproduction parameters were affected in chronic studies. It is highly acutely toxic and moderately chronically toxic to aquatic organisms and moderately toxic to sediment dwelling organisms chronically. The main metabolites range from practically non-toxic to moderately toxic to aquatic organisms. Oxathiapiprolin and its main metabolites are at worst slightly/very slightly toxic to honey bees. No effects on reproduction on earthworms was observed. Terrestrial arthropods, both soil dwelling and above ground, were insensitive to oxathiapiprolin and its major metabolites at the tested rates. No significant adverse effects were observed on soil micro-organisms and terrestrial plants.
In considering the submitted fate and effects data, DotE has given particular attention to environmental exposure arising from the proposed use of oxathiapiprolin. The risk assessment to aquatic systems from spray drift and run-off with multiple applications concluded that the acute and chronic risks can be considered acceptable for the protection of the aquatic and sediment systems for the proposed use on vegetables and poppies.
Risks from the exposure of the product to terrestrial organisms, including birds, small mammals, honey bees, earthworms, soil macro- and micro-organisms, beneficial non-target arthropods and non-target plants were assessed based on the available endpoints and proposed application rate of the product. The environmental risk assessment has concluded that the risks from the proposed use of the product will be acceptable to terrestrial organisms. 
The risk assessment determined that DUPONT ZORVEC ENICADE FUNGICIDE is unlikely to pose an environmental risk under the proposed use pattern. The APVMA has considered the findings of DotE and accepts these conclusions.
2.	The APVMA has evaluated the applications and in its assessment in relation to whether the efficacy criteria have been met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:
(i)	In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials supporting the efficacy of DUPONT ZORVEC ENICADE FUNGICIDE adequately demonstrates that if used according to the product label directions, the product is effective for its proposed use.
3.	The APVMA has evaluated the applications and in its assessment in relation to whether the trade criteria have been met in accordance with the definition set out in section 5C of the Agvet Code, and proposes to determine that:
(i)	The APVMA is satisfied that the proposed use of DUPONT ZORVEC ENICADE FUNGICIDE would not adversely affect trade between Australia and places outside Australia.
The risk to trade is considered to be low, as none of the proposed use patterns in crops involve major export commodities, and finite residues of oxathiapiprolin are not expected to be found in mammalian or poultry meat or offal, eggs, or milk.
FuRther Information
A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Public Consultation’ page, apvma.gov.au/news-and-publications/public-consultations or by contacting the evaluator listed below.
Making a Submission
In accordance with section 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether DUPONT ZORVEC ENICADE FUNGICIDE should be registered. Submissions should relate only to matters that are required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have been met. Submissions should state the grounds on which they are based. 
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post. 
Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and in determining appropriate conditions of registration and product labelling.
When making a submission please include:
•	contact name
•	company or group name (if relevant)
•	email or postal address
•	the date you made the submission.
All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially.
Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for registration should be addressed in writing to: 
Case Management and Administration Unit 
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4701
Fax:	+61 2 6210 4721
Email:	enquiries@apvma.gov.au 
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 2015 (No. 11).
The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012.
The MRL Standard is accessible via the ComLaw website www.comlaw.gov.au/or the links above.
For further information please contact:
MRL Contact Officer 
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4897
Fax:	+61 22 6210 4840
Email:	enquiries@apvma.gov.au 

Proposal to amend Schedule 20 of the revised Australia New Zealand Food Standards Code 
In the previous notice, the APVMA gazetted amendments which it has approved varying maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in the APVMA’s MRL Standard, have been made.
Under section 82 of the Food Standards Australia New Zealand Act 1991, the APVMA is proposing to incorporate those variations (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2015 (No. 11)) in Schedule 20 of the revised Australia New Zealand Food Standards Code which commences on 1 March 2016 (revised Code), with the repeal of Chapters 1 and 2 of the current 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 FSANZ are satisfied, based on dietary exposure assessments and current health standards, that the proposed limits are not harmful to public health. 
The Agreement between the Government of Australia and the Government of New Zealand concerning a Joint Food Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food. 
Food Standards Australia New Zealand (FSANZ) will make a Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO). 
The APVMA invites comment on these proposals. Details on how to make a submission appear near the end of this notice, below the details of the proposed amendment. 
The APVMA will consider any public comments made in response to this proposal. If the APVMA decides to proceed with the proposal, it will further notify any variations it makes to Schedule 20 in the APVMA Gazette. The variations will take effect as from the date of that subsequent notice.

Draft variations to the Australia New Zealand Food Standards Code
Note: The following proposed amendments are in a format that accords with the proposed amending Legislative Instrument which, in turn, has to be consistent with the existing format of Schedule 20 in the revised Code
Proposed AMENDMENT (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2015 (No. 11))
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:  Oxathiapiprolin	
Permitted residue:  Oxathiapiprolin	
Brassica (cole or cabbage) vegetables, Head cabbages, Flowerhead brassicas	2	
Bulb vegetables [except onion, bulb]	1	
Cardoon	15	
Edible offal (mammalian)	*0.01	
Eggs	*0.01	
Fruiting vegetables, cucurbits	0.2	
Leafy vegetables [except lettuce, head]	15	
Lettuce, head	2	
Meat (mammalian) (in the fat)	*0.01	
Milks	*0.01	
Onion, bulb	0.02	
Poppy seed	*0.01	
Poultry, edible offal of	*0.01	
Poultry meat (in the fat)	*0.01	
[1.2]	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	
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	
Tree nuts [except almonds; pistachio nut]	0.02	

Agvet chemical:  Glyphosate	
Permitted residue:  Sum of glyphosate and Aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosate	
Lemon myrtle	T20	
Native foods [except lemon myrtle]	T2	

Agvet chemical:  Propiconazole	
Permitted residue:  Propiconazole	
Herbs	T10	
[1.3]	inserting for each of the following chemicals the foods and associated MRLs in alphabetical order
Agvet chemical:  Aminoethoxyvinyl-glycine	
Permitted residue:  Aminoethoxyvinylglycine	
Cherries	*0.05	

Agvet chemical:  Chlorantraniliprole	
Permitted residue:  Plant commodities and animal commodities other than milk: Chlorantraniliprole	
Milk:  Sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliprole	
Tree nuts [except almonds; pistachio nut; walnuts]	0.02	
Walnuts	T0.05	

Agvet chemical:  Etoxazole	
Permitted residue:  Etoxazole	
Maize	T*0.01	
Popcorn	T*0.01	

Agvet chemical:  Flumioxazin	
Permitted residue:  Flumioxazin	
Grapes	*0.01	

Agvet chemical:  Glyphosate	
Permitted residue:  Sum of glyphosate and Aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosate	
Native foods	T2	

Agvet chemical:  Prochloraz	
Permitted residue:  Sum of prochloraz and its metabolites containing the 2,4,6-trichlorophenol moiety, expressed as prochloraz	
Lettuce, leaf	T3	

Agvet chemical:  Propiconazole	
Permitted residue:  Propiconazole	
Herbs [except parsley]	T10	
Parsley	T30	

Agvet chemical:  Sethoxydim	
Permitted residue:  Sum of sethoxydim and metabolites containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulfoxides and sulfones, expressed as sethoxydim	
Chia	T0.7	

Agvet chemical:  Spirotetramat	
Permitted residue:  Sum of spirotetramat, and cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, expressed as spirotetramat	
Fig	T1	

Agvet chemical:  Triclabendazole	
Permitted residue:  Sum of triclabendazole and metabolites oxidisable to keto-triclabendazole and expressed as keto-triclabendazole equivalents	
Milks	0.01	
[1.4]	omitting for each of the following chemicals, the maximum residue limit for the food and substituting
Agvet chemical:  Difenoconazole	
Permitted residue:  Difenoconazole	
Celeriac	T1	

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 of the Australia New Zealand Food Standards Code. Submissions should be strictly confined to relevant matters that the APVMA must consider (such as public health and safety) which are associated with the occurrence of the proposed residues in foods. Comments received outside these grounds will not be considered by the APVMA. Claims made in submissions should be supported wherever possible by referencing or including relevant studies, research findings, trials, surveys etc. Technical information should be in sufficient detail to allow independent scientific assessment. 
Please note that FSANZ will make a SPS notification to the WTO and submissions related to impacts on international trade should be made to FSANZ in response to that notification. 
Submissions must be made in writing and should be clearly marked as a ‘submission on the proposed amendment to Schedule 20 and quote the correct amendment number.
DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (AEDT) 26 January 2016
SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL ONLY BE CONSIDERED BY PRIOR ARRANGEMENT
Submissions received after this date will only be considered if agreement for an extension has been given prior to this closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to the submission period. 
For further information please contact:
MRL Contact Officer 
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4897
Fax:	+61 2 6210 4840
Email:	enquiries@apvma.gov.au