Commonwealth of Australia	Gazette	
No. APVMA 6, Tuesday, 22 March 2016
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 2016
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: 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
APVMA review of maldison—suspension of product and associated labels
New veterinary active constituent—bixafen
New agricultural chemical products bixafen in aviator xpro foliar fungicde
Final pesticide and veterinary medicines product sales 2014–15 financial year

Agricultural Chemical Products and Approved Labels 
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1.	Agricultural Products Based on New Active Constituents
Application no.:	48927	
Product name:	Specticle Herbicide	
Active constituent/s:	200 g/L indaziflam	
Applicant name:	Bayer CropScience Pty Ltd	
Applicant ACN:	000 226 022	
Summary of use	For the pre-emergent control of summer grass, crowsfoot grass and winter
grass in turf on golf course fairways	
Date of registration/approval:	2 March 2016	
Product registration no.:	64673	
Label approval no.:	64673/48927	
2.	agricultural Products Based on Existing Active Constituents
Application no.:	60431	
Product name:	Family Protection Aerogard Extreme Protection 40% Deet 8 Hours Protection Effective In Areas Of Intense Insect Activity Insect Repellent	
Active constituent/s:	40 g/kg n-octyl bicycloheptene dicarboximide, 400 g/kg diethyltoluamide	
Applicant name:	Reckitt Benckiser (Australia) Pty Limited	
Applicant ACN:	003 274 655	
Summary of use	For use as a personal insect repellent	
Date of registration/approval:	29 February 2016	
Product registration no.:	69293	
Label approval no.:	69293/60431	

Application no.:	101357	
Product name:	Storm Soft Bait Rodenticide	
Active constituent/s:	0.05 g/kg flocoumafen	
Applicant name:	BASF Australia Ltd	
Applicant ACN:	008 437 867	
Summary of use	For the control of rats and mice in and around industrial, commercial, agricultural and domestic buildings, also controls rats and mice resistant to warfarin	
Date of registration/approval:	1 March 2016 	
Product registration no.:	80663	
Label approval no.:	80663/101357	

Application no.:	103647	
Product name:	Eureka! Glyphosate 540 SL Herbicide	
Active constituent/s:	540 g/L glyphosate present as the potassium salt	
Applicant name:	Eureka! Agresearch Pty Ltd	
Applicant ACN:	086 194 738	
Summary of use	For the non-selective control of many annual and perennial weeds	
Date of registration/approval:	2 March 2016 	
Product registration no.:	81684	
Label approval no.:	81684/103647	

Application no.:	102487	
Product name:	I-MOX 700 WG Herbicide	
Active constituent/s:	700 g/kg imazamox	
Applicant name:	Shandong Rainbow International Co., Ltd	
Applicant ACN:	N/A	
Summary of use	For the post-emergence control of certain annual grass and broadleaf weeds in field peas, legume-based pastures, lucerne, peanuts and soybeans	
Date of registration/approval:	2 March 2016 	
Product registration no.:	81174	
Label approval no.:	81174/102487	

Application no.:	104862	
Product name:	Relyon Garner 750WG Herbicide	
Active constituent/s:	750 g/kg chlorsulfuron	
Applicant name:	Ruralco Holdings Limited	
Applicant ACN:	009 660 879	
Summary of use	For the control of annual ryegrass and certain broadleaf weeds in wheat, barley, oats, cereal rye and triticale	
Date of registration/approval:	2 March 2016	
Product registration no.:	82041	
Label approval no.:	82041/104862	

Application no.:	62951	
Product name:	Peroxypure395 Chlorine Free Pool Sanitiser	
Active constituent/s:	395 g/L hydrogen peroxide	
Applicant name:	Waterco Limited	
Applicant ACN:	002 070 733	
Summary of use	For control of bacteria in private (domestic) spas and pools	
Date of registration/approval:	3 March 2016	
Product registration no.:	69474	
Label approval no.:	69474/62951	

Application no.:	101690	
Product name:	Biforce Low-Odour 200EC Insecticide	
Active constituent/s:	200 g/L bifenthrin	
Applicant name:	Sherwood Chemicals Public Company Limited	
Applicant ACN:	N/A	
Summary of use	For the control of a range of urban pests	
Date of registration/approval:	3 March 2016	
Product registration no.:	80803	
Label approval no.:	80803/101690	

Application no.:	104140	
Product name:	Relyon Insight 750 SG Herbicide	
Active constituent/s:	750 g/kg clopyralid present as the potassium salt	
Applicant name:	Ruralco Holdings Limited	
Applicant ACN:	009 660 879 	
Summary of use	For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures and fallow land	
Date of registration/approval:	3 March 2016	
Product registration no.:	81837	
Label approval no.:	81837/104140	

Application no.:	102857	
Product name:	Eurochem 6-BA Plant Growth Regulator	
Active constituent/s:	20 g/L 6-benzyladenine	
Applicant name:	Ronic International Pty Limited	
Applicant ACN:	101 193 131	
Summary of use	For the use of reducing fruit set, increasing fruit size and improving firmness of harvested apples	
Date of registration/approval:	4 March 2016	
Product registration no.:	81342	
Label approval no.:	81342/102857	

Application no.:	104834	
Product name:	Tapout 240 Herbicide	
Active constituent/s:	240 g/L clethodim	
Applicant name:	Crop Culture Pty Ltd	
Applicant ACN:	142 860 473	
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, lettuce, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans	
Date of registration/approval:	4 March 2016	
Product registration no.:	82035	
Label approval no.:	82035/104834	

Application no.:	104051	
Product name:	Relyon Triflon 480EC Herbicide	
Active constituent/s:	480 g/L trifluralin	
Applicant name:	Ruralco Holdings Limited	
Applicant ACN:	009 660 879	
Summary of use	For the control of annual grasses and certain broadleaf weeds in certain horticultural agricultural crops	
Date of registration/approval:	7 March 2016 	
Product registration no.:	81784	
Label approval no.:	81784/104051	

Application no.:	104451	
Product name:	Weed Force Evict 450 Herbicide	
Active constituent/s:	450 g/L glyphosate present as the isopropylamine salt	
Applicant name:	Weed Force Pty Ltd	
Applicant ACN:	602 207 152	
Summary of use	For the control of a wide range of annual and perennial weeds	
Date of registration/approval:	7 March 2016	
Product registration no.:	81935	
Label approval no.:	81935/104451	

Application no.:	104990	
Product name:	O-MAT 290 SL Insecticide	
Active constituent/s:	290 g/L omethoate (an anticholinesterase compound)	
Applicant name:	Arysta Lifescience Australia Pty Ltd	
Applicant ACN:	005 225 507	
Summary of use	For the control of redlegged earth mite, blue oat mite and lucerne flea on pastures, cereals, oilseed and legume crops, and bluegreen aphid and cowpea aphid on pasture legumes, lucerne, faba beans and vetch	
Date of registration/approval:	7 March 2016	
Product registration no.:	82095	
Label approval no.:	82095/104990	

Application no.:	104867	
Product name:	Propeller 250 Fungicide	
Active constituent/s:	250 g/L propiconazole	
Applicant name:	Crop Culture Pty Ltd	
Applicant ACN:	142 860 473	
Summary of use	For the control of certain fungal diseases of bananas, oats, peanuts, perennial ryegrass, pineapples, stone fruit, sugarcane, wheat and other crops. For the control of dollar spot in bent and Queensland blue couch and spring dead spot in couch	
Date of registration/approval:	8 March 2016 	
Product registration no.:	82044	
Label approval no.:	82044/104867	

Application no.:	104887	
Product name:	Kelpie DFF + Brom MX Herbicide	
Active constituent/s:	250 g/L bromoxynil present as the octanoate, 25 g/L diflufenican	
Applicant name:	Sinochem International Australia Pty Ltd	
Applicant ACN:	160 164 616	
Summary of use	For the control of certain broadleaf weeds in winter cereals and pastures	
Date of registration/approval:	8 March 2016 	
Product registration no.:	82057	
Label approval no.:	82057/104887	

Application no.:	104830	
Product name:	Tebby 430 Fungicide	
Active constituent/s:	430 g/L tebuconazole	
Applicant name:	Crop Culture Pty Ltd	
Applicant ACN:	142 860 473	
Summary of use	For the control of leaf spot and leaf speckle on bananas; rust, leaf spot and net blotch of peanuts; foliar diseases on cereal crops; and other diseases on beans, lettuce, peas, onions, pawpaw, pyrethrum and ryegrass and fescue seed crops	
Date of registration/approval:	8 March 2016	
Product registration no.:	82030	
Label approval no.:	82030/104830	

Application no.:	63370	
Product name:	eChem Clopyralid 300 Herbicide	
Active constituent/s:	300 g/L clopyralid present as the triisopropanolamine salt	
Applicant name:	eChem (Aust) Pty Limited	
Applicant ACN:	089 133 095	
Summary of use	For the control of a wide range of broadleaf weeds in wheat, barley,triticale, oats, pastures, canola, fallow land, forests and industrial situations	
Date of registration/approval:	8 March 2016	
Product registration no.:	70397	
Label approval no.:	70397/63370	

Application no.:	104890	
Product name:	Kelpie DFF + MCPA MX Herbicide	
Active constituent/s:	250 g/L MCPA present as the ethyl hexyl ester, 25 g/L diflufenican	
Applicant name:	Sinochem International Australia Pty Ltd	
Applicant ACN:	160 164 616	
Summary of use	For the control of certain broadleaf weeds in winter cereals and clover	
Date of registration/approval:	9 March 2016 	
Product registration no.:	82058	
Label approval no.:	82058/104890	

Application no.:	104411	
Product name:	Apparent Fluroxypyr 400 Herbicide	
Active constituent/s:	400 g/L fluroxypyr present as the methyl heptyl ester	
Applicant name:	Apparent Pty. Ltd	
Applicant ACN:	143 724 136	
Summary of use	For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, millets, pastures, poppies, sorghum, sugarcane, sweet corn and 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:	9 March 2016	
Product registration no.:	81917	
Label approval no.:	81917/104411	

Application no.:	104065	
Product name:	Relyon Oxon 240EC Herbicide	
Active constituent/s:	240 g/L oxyfluorfen	
Applicant name:	Ruralco Holdings Limited	
Applicant ACN:	009 660 879	
Summary of use	For the selective control of certain broadleaf and grass weeds	
Date of registration/approval:	9 March 2016 	
Product registration no.:	81796	
Label approval no.:	81796/104065	

Application no.:	104774	
Product name:	AC Capsize 500 SC Fungicide	
Active constituent/s:	500 g/L chlorothalonil	
Applicant name:	Axichem Pty Ltd	
Applicant ACN:	131 628 594	
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 and vegetables	
Date of registration/approval:	9 March 2016	
Product registration no.:	81995	
Label approval no.:	81995/104774	

Application no.:	104457	
Product name:	Relyon Rialto 750WG Herbicide	
Active constituent/s:	750 g/kg triasulfuron	
Applicant name:	Ruralco Holdings Limited	
Applicant ACN:	009 660 879	
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:	9 March 2016 	
Product registration no.:	81938	
Label approval no.:	81938/104457	

Application no.:	104510	
Product name:	AC Rampant Selective Herbicide	
Active constituent/s:	475 g/L 2,4-D present as the dimethylamine + diethanolamine salts	
Applicant name:	Axichem Pty Ltd	
Applicant ACN:	131 628 594	
Summary of use	For the control of broadleaf weeds prior to sowing crops and pastures in conservation tillage situations and for selective weed control in crops	
Date of registration/approval:	10 March 2016 	
Product registration no.:	81968	
Label approval no.:	81968/104510	

Application no.:	104347	
Product name:	OzCrop Isoxaflutole 750 WG Herbicide	
Active constituent/s:	750 g/kg isoxaflutole	
Applicant name:	OzCrop Pty. Ltd	
Applicant ACN:	160 656 431	
Summary of use	For the control and suppression of various broadleaf weeds and grasses in sugarcane and chickpeas	
Date of registration/approval:	10 March 2016	
Product registration no.:	81887	
Label approval no.:	81887/104347	

Application no.:	104037	
Product name:	Ronaldo 240 Herbicide	
Active constituent/s:	240 g/L oxyfluorfen	
Applicant name:	Crop Culture Pty Ltd	
Applicant ACN:	142 860 473	
Summary of use	For the selective control of certain broadleaf and grass weeds	
Date of registration/approval:	11 March 2016	
Product registration no.:	81777	
Label approval no.:	81777/104037	

Application no.:	101091	
Product name:	Propermide 900 WG Herbicide	
Active constituent/s:	900 g/kg propyzamide	
Applicant name:	Agro-Alliance (Australia) Pty Ltd	
Applicant ACN:	130 864 603	
Summary of use	For the selective control of certain grasses and broad leaf weeds in lettuce, sports turf, home lawns and legume seed crops and pastures	
Date of registration/approval:	11 March 2016	
Product registration no.:	80551	
Label approval no.:	80551/101091	

Application no.:	104831	
Product name:	Mongrel 750 Herbicide	
Active constituent/s:	750 g/kg clopyralid present as the potassium salt	
Applicant name:	Crop Culture Pty Ltd	
Applicant ACN:	142 860 473	
Summary of use	For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures and fallow land	
Date of registration/approval:	11 March 2016 	
Product registration no.:	82031	
Label approval no.:	82031/104831	

Application no.:	104923	
Product name:	Relyon Zulfa 800wg Fungicide	
Active constituent/s:	800 g/kg sulfur (S) present as elemental sulfur	
Applicant name:	Ruralco Holdings Limited	
Applicant ACN:	009 660 879	
Summary of use	For the control of powdery mildew, rust and mites in pome and stone fruit, citrus, grapevines, kiwifruit, strawberries and some vegetables	
Date of registration/approval:	11 March 2016 	
Product registration no.:	82072	
Label approval no.:	82072/104923	

Application no.:	104067	
Product name:	Relyon Triamate 500EC Herbicide	
Active constituent/s:	500 g/L tri-allate	
Applicant name:	Ruralco Holdings Limited	
Applicant ACN:	009 660 879	
Summary of use	For the control of wild oats in wheat, triticale, chickpeas, barley, peas, linseed, lupins, canola (rapeseed), faba beans and safflower	
Date of registration/approval:	15 March 2016	
Product registration no.:	81798	
Label approval no.:	81798/104067	

Application no.:	104874	
Product name:	Agro-Essence Sulfosulfuron 750WG Herbicide	
Active constituent/s:	750 g/kg sulfosulfuron	
Applicant name:	Agro-Alliance (Australia) Pty Ltd	
Applicant ACN:	130 864 603	
Summary of use	For the control of certain weeds in wheat and triticale	
Date of registration/approval:	15 March 2016	
Product registration no.:	82051	
Label approval no.:	82051/104874	
3.	Variations of registration 
Application no.:	105555	
Product name:	Unistar Selective Herbicide	
Active constituent/s:	750 g/kg triasulfuron	
Applicant name:	UPL Australia Limited	
Applicant ACN:	066 391 384	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘UNI-STAR SELECTIVE HERBICIDE’ to ‘UNISTAR SELECTIVE HERBICIDE’	
Date of variation:	2 February 2016	
Product no.:	62782	
Label approval no.:	62782/105555	

Application no:	105551	
Product name:	Nemasol	
Active constituent/s:	423 g/L metham present as sodium salt	
Applicant name:	Eastman Chemical Australia Pty Ltd	
Applicant ACN:	077 977 649	
Summary of variation:	To change the name that appears on the label from ‘TAMINCO METHAM SODIUM 510 SOIL FUMIGANT’ to ‘NEMASOL’	
Date of variation:	3 February 2016	
Product registration no.:	67922	
Label approval no.:	67922/105551	

Application no.:	105582	
Product name:	Apparent Weedfree RTU Herbicide	
Active constituent/s:	7.2 g/L glyphosate present as the isopropylamine salt	
Applicant name:	Apparent Pty. Ltd	
Applicant ACN:	143 724 136	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘APPARENT KNOCK-OUT RTU HERBICIDE’ to ‘APPARENT WEEDFREE RTU HERBICIDE’	
Date of variation:	5 February 2016	
Product no.:	80396	
Label approval no.:	80396/105582	

Application no:	105682	
Product name:	Relyon Oxon 240 Herbicide	
Active constituent/s:	240 g/L oxyfluorfen	
Applicant name:	Profeng Australia Pty Ltd	
Applicant ACN:	156 055 533	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘YGEL OXYFLUORFEN HERBICIDE’ to ‘RELYON OXON 240 HERBICIDE’	
Date of variation:	16 February 2016	
Product registration no.:	64219	
Label approval no.:	64219/105682	

Application no:	101154	
Product name:	Fipforce Aqua Termiticide & Insecticide	
Active constituent/s:	100 g/L fipronil	
Applicant name:	Sherwood Chemicals Public Company Limited	
Applicant ACN:	N/A	
Summary of variation:	To extend the use of the product to include pre-construction, reticulation systems, nests in poles and trees and wall cavity treatment	
Date of variation:	2 March 2016	
Product registration no.:	63789	
Label approval no.:	63789/101154	

Application no:	101039	
Product name:	Custodia Fungicide	
Active constituent/s:	200 g/L tebuconazole, 120 g/L azoxystrobin	
Applicant name:	Adama Australia Pty Limited	
Applicant ACN:	050 328 973	
Summary of variation:	For the extension of use to include control of rust, shot hole and brown rot of almonds and to vary the current use pattern for control of septoria tritici blotch (STB) in wheat	
Date of variation:	3 March 2016	
Product registration no.:	66541	
Label approval no.:	66541/101039	

Application no:	104924	
Product name:	Black Flag Odourless Fly & Mosquito Killer	
Active constituent/s:	1.1 g/kg esbiothrin, 0.5 g/kg permethrin	
Applicant name:	Reckitt Benckiser (Australia) Pty Limited	
Applicant ACN:	003 274 655	
Summary of variation:	To add additional pack sizes	
Date of variation:	3 March 2016	
Product registration no.:	67835	
Label approval no.:	67835/104924	

Application no:	104946	
Product name:	Monaco Herbicide	
Active constituent/s:	750 g/kg sulfosulfuron	
Applicant name:	Crop Culture Pty Ltd	
Applicant ACN:	142 860 473	
Summary of variation:	To alter the approved pack size	
Date of variation:	9 March 2016	
Product registration no.:	68230	
Label approval no.:	68230/104946	

Application no:	104897	
Product name:	Tri-Form 35 Soil Fumigant	
Active constituent/s:	630 g/kg (844 g/L) 1,3-dichloropropene, 345 g/kg (465 g/L) chloropicrin	
Applicant name:	Trical Australia Pty Ltd	
Applicant ACN:	600 066 966	
Summary of variation:	To amend the pack size	
Date of variation:	09 March 2016	
Product registration no.:	64245	
Label approval no.:	64245/104897	

Application no:	100190	
Product name:	Yates Confidor Lawn & Garden Insecticide	
Active constituent/s:	15 g/L imidacloprid	
Applicant name:	Bayer Cropscience Pty Ltd	
Applicant ACN:	000 226 022	
Summary of variation:	To add pack sizes and extend uses	
Date of variation:	10 March 2016	
Product registration no.:	60571	
Label approval no.:	60571/100190	

Application no:	104776	
Product name:	Yates Lawnweedkiller Bindii & Clover Concentrate	
Active constituent/s:	25 g/L dicamba present as the dimethylamine salt, 150 g/L MCPA present as the dimethylamine 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 ‘YATES BINDII & CLOVER WEEDER’ to ‘YATES LAWNWEEDKILLER BINDII & CLOVER CONCENTRATE’ and to add a range of pack sizes	
Date of variation:	10 March 2016	
Product registration no.:	58022	
Label approval no.:	58022/104776	

Application no:	104898	
Product name:	Tri-Form Soil Fumigant	
Active constituent/s:	970 g/kg (1174 g/L) 1,3-dichloropropene	
Applicant name:	Trical Australia Pty Ltd	
Applicant ACN:	600 066 966	
Summary of variation:	To amend the pack sizes	
Date of variation:	10 March 2016	
Product registration no.:	64246	
Label approval no.:	64246/104898	

Application no:	104757	
Product name:	Ceasefire 2G Granular Insecticide	
Active constituent/s:	2 g/kg bifenthrin	
Applicant name:	Turf Culture Pty Ltd	
Applicant ACN:	117 986 615	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘TURF CULTURE CEASEFIRE 2G GRANULAR INSECTICIDE’ to ‘CEASEFIRE 2G GRANULAR INSECTICIDE’	
Date of variation:	11 March 2016	
Product registration no.:	61005	
Label approval no.:	61005/104757	

Application no:	104761	
Product name:	Trinex 120 ME Growth Regulator	
Active constituent/s:	120 g/L trinexapac-ethyl	
Applicant name:	Turf Culture Pty Ltd	
Applicant ACN:	117 986 615	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘TURF CULTURE TRINEX 120 ME GROWTH REGULATOR’ to ‘TRINEX 120 ME GROWTH REGULATOR’	
Date of variation:	11 March 2016	
Product registration no.:	64368	
Label approval no.:	64368/104761	

Application no:	104931	
Product name:	Pea Beu Insect Killer Fast Kill Low Irritant Odourless	
Active constituent/s:	1.08 g/kg tetramethrin, 0.25 g/kg d-phenothrin, 2.17 g/kg piperonyl butoxide, 3.18 g/kg n-octyl bicycloheptene dicarboximide	
Applicant name:	Reckitt Benckiser (Australia) Pty Limited	
Applicant ACN:	003 274 655	
Summary of variation:	To add additional pack sizes	
Date of variation:	15 March 2016	
Product registration no.:	67874	
Label approval no.:	67874/104931	

Application no:	104930	
Product name:	Pea Beu Insect Killer Fast Kill Low Irritant Lemon Fresh	
Active constituent/s:	1.08 g/kg tetramethrin 20:80, 0.25 g/kg phenothrin 20:80, 2.17 g/kg piperonyl butoxide, 3.18 g/kg n-octyl bicycloheptene dicarboximide	
Applicant name:	Reckitt Benckiser (Australia) Pty Limited	
Applicant ACN:	003 274 655	
Summary of variation:	To add additional pack sizes	
Date of variation:	15 March 2016	
Product registration no.:	53238	
Label approval no.:	53238/104930	

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.	Variations of registration 
Application no:	105546	
Product name:	Troy Entera Allwormer Tablets For Small Dogs	
Active constituent/s:	Each tablet contains: 75 mg febantel, 15 mg praziquantel, 14.9 mg pyrantel as the embonate	
Applicant name:	Troy Laboratories Pty Ltd	
Applicant ACN:	000 283 769	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘TROY VANGARD ALLWORMER TABLETS FOR SMALL DOGS’ to ‘TROY ENTERA ALLWORMER TABLETS FOR SMALL DOGS’	
Date of variation:	1 February 2016	
Product registration no.:	67312	
Label approval no.:	67312/105546	

Application no:	105548	
Product name:	Troy Entera Allwormer Tablets For Medium Dogs	
Active constituent/s:	Each tablet contains: 250 mg febantel, 50 mg praziquantel, 49.8 mg pyrantel (as the embonate)	
Applicant name:	Troy Laboratories Pty Ltd	
Applicant ACN:	000 283 769	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘TROY VANGARD ALLWORMER TABLETS FOR MEDIUM DOGS’ to ‘TROY ENTERA ALLWORMER TABLETS FOR MEDIUM DOGS’	
Date of variation:	1 February 2016	
Product registration no.:	67313	
Label approval no.:	67313/105548	

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.
Note: The APVMA is currently assigning separate approval numbers for vet actives which means some vet actives listed in this gazette will have an approval date that occurred in the past. For more information.
1.	active consitutent 
Application no.:	2455	
Active constituent/s:	Sodium Hyaluronate	
Applicant name:	Merial Australia Pty Ltd	
Applicant ACN:	071 187 285	
Summary of use:	For use in veterinary chemical products	
Date of approval:	24 March 1995	
Approval no.:	82357	

Application no.:	4199	
Active constituent/s:	Triclabendazole	
Applicant name:	Elanco Australasia Pty Ltd	
Applicant ACN:	076 745 198	
Summary of use:	For use in veterinary chemical products	
Date of approval:	6 April 1995	
Approval no.:	82176	

Application no.:	3872	
Active constituent/s:	Salinomycin Sodium	
Applicant name:	Huvepharma EOOD	
Applicant ACN:	N/A	
Summary of use:	For use in veterinary chemical products	
Date of approval:	19 April 1996	
Approval no.:	82327	

Application no.:	6121	
Active constituent/s:	Ketoprofen	
Applicant name:	Merial Australia Pty Ltd	
Applicant ACN:	071 187 285	
Summary of use:	For use in veterinary chemical products	
Date of approval:	24 October 1996	
Approval no.:	82360	

Application no.:	26597	
Active constituent/s:	Oxytetracycline Hydrochloride	
Applicant name:	Phibro Animal Health Pty Limited	
Applicant ACN:	093 869 991	
Summary of use:	For use in veterinary chemical products	
Date of approval:	16 April 1997	
Approval no.:	82410	

Application no.:	9717	
Active constituent/s:	Nandrolone Decanoate	
Applicant name:	RWR Veterinary Products Pty Ltd	
Applicant ACN:	088 423 018	
Summary of use:	For use in veterinary chemical products	
Date of approval:	28 April 1998	
Approval no.:	82157	

Application no.:	26510	
Active constituent/s:	Morantel Citrate	
Applicant name:	Phibro Animal Health Pty Limited	
Applicant ACN:	093 869 991	
Summary of use:	For use in veterinary chemical products	
Date of approval:	29 April 1998	
Approval no.:	82421	

Application no.:	17358	
Active constituent/s:	Testosterone	
Applicant name:	RWR Veterinary Products Pty Ltd	
Applicant ACN:	088 423 018	
Summary of use:	For use in veterinary chemical products	
Date of approval:	19 July 1999	
Approval no.:	82155	

Application no.:	17987	
Active constituent/s:	Testosterone Propionate	
Applicant name:	RWR Veterinary Products Pty Ltd	
Applicant ACN:	088 423 018	
Summary of use:	For use in veterinary chemical products	
Date of approval:	21 December 1999	
Approval no.:	82154	

Application no.:	17987	
Active constituent/s:	Testosterone Cypionate	
Applicant name:	RWR Veterinary Products Pty Ltd	
Applicant ACN:	088 423 018	
Summary of use:	For use in veterinary chemical products	
Date of approval:	21 December 1999	
Approval no.:	82153	

Application no.:	11019	
Active constituent/s:	Inositol	
Applicant name:	Ceva Animal Health Pty Ltd	
Applicant ACN:	002 692 426	
Summary of use:	For use in veterinary chemical products	
Date of approval:	26 April 2000	
Approval no.:	82318	

Application no.:	19658	
Active constituent/s:	Lincomycin Hydrochloride	
Applicant name:	Zoetis Australia Pty Ltd	
Applicant ACN:	156 476 425	
Summary of use:	For use in veterinary chemical products	
Date of approval:	25 July 2000	
Approval no.:	81641	
Application no.:	21919	
Active constituent/s:	Flavophospholipol	
Applicant name:	Huvepharma EOOD	
Applicant ACN:	N/A	
Summary of use:	For use in veterinary chemical products	
Date of approval:	13 March 2001	
Approval no.:	82328	

Application no.:	26401	
Active constituent/s:	Monensin Sodium	
Applicant name:	Phibro Animal Health Pty Limited	
Applicant ACN:	093 869 991	
Summary of use:	For use in veterinary chemical products	
Date of approval:	26 November 2002	
Approval no.:	82398	

Application no.:	29139	
Active constituent/s:	Nicarbazin	
Applicant name:	Phibro Animal Health Pty Limited	
Applicant ACN:	093 869 991	
Summary of use:	For use in veterinary chemical products	
Date of approval:	8 April 2003	
Approval no.:	82391	

Application no.:	30915	
Active constituent/s:	Carprofen	
Applicant name:	Apex Laboratories Pty Ltd	
Applicant ACN:	000 397 240	
Summary of use:	For use in veterinary chemical products	
Date of approval:	11 September 2003	
Approval no.:	82092	

Application no.:	31476	
Active constituent/s:	Clindamycin Hydrochloride	
Applicant name:	Chanelle Animal Health Ltd	
Applicant ACN:	N/A	
Summary of use:	For use in veterinary chemical products	
Date of approval:	4 March 2004	
Approval no.:	82458	

Application no.:	33441	
Active constituent/s:	Dinitolmide	
Applicant name:	Phibro Animal Health Pty Limited	
Applicant ACN:	093 869 991	
Summary of use:	For use in veterinary chemical products	
Date of approval:	27 September 2004	
Approval no.:	82372	

Application no.:	33163	
Active constituent/s:	Zinc Bacitracin	
Applicant name:	Phibro Animal Health Pty Limited	
Applicant ACN:	093 869 991	
Summary of use:	For use in veterinary chemical products	
Date of approval:	23 March 2005	
Approval no.:	82385	

Application no.:	35625	
Active constituent/s:	Methandriol Dipropionate	
Applicant name:	RWR Veterinary Products Pty Ltd	
Applicant ACN:	088 423 018	
Summary of use:	For use in veterinary chemical products	
Date of approval:	12 April 2005	
Approval no.:	82139	

Application no.:	36829	
Active constituent/s:	Boldenone Undecylenate	
Applicant name:	RWR Veterinary Products Pty Ltd	
Applicant ACN:	088 423 018	
Summary of use:	For use in veterinary chemical products	
Date of approval:	4 July 2006	
Approval no.:	82135	

Application no.:	35928	
Active constituent/s:	Omeprazole	
Applicant name:	Ceva Animal Health Pty Ltd	
Applicant ACN:	002 692 426	
Summary of use:	For use in veterinary chemical products	
Date of approval:	22 February 2007	
Approval no.:	82185	

Application no.:	42063	
Active constituent/s:	Oxantel Embonate	
Applicant name:	RWR Veterinary Products Pty Ltd	
Applicant ACN:	088 423 018	
Summary of use:	For use in veterinary chemical products	
Date of approval:	30 July 2007	
Approval no.:	82045	

Application no.:	42063	
Active constituent/s:	Pyrantel Embonate	
Applicant name:	RWR Veterinary Products Pty Ltd	
Applicant ACN:	088 423 018	
Summary of use:	For use in veterinary chemical products	
Date of approval:	30 July 2007	
Approval no.:	82048	

Application no.:	40472	
Active constituent/s:	Dimethylglycine Hydrochloride	
Applicant name:	Ceva Animal Health Pty Ltd	
Applicant ACN:	002 692 426	
Summary of use:	For use in veterinary chemical products	
Date of approval:	19 February 2008	
Approval no.:	82187	

Application no.:	36334	
Active constituent/s:	Praziquantel	
Applicant name:	Chanelle Animal Health Ltd	
Applicant ACN:	N/A	
Summary of use:	For use in veterinary chemical products	
Date of approval:	31 March 2008	
Approval no.:	82471	

Application no.:	36334	
Active constituent/s:	Fenbendazole	
Applicant name:	Chanelle Animal Health Ltd	
Applicant ACN:	N/A	
Summary of use:	For use in veterinary chemical products	
Date of approval:	31 March 2008	
Approval no.:	82473	

Application no.:	41964	
Active constituent/s:	Tilmicosin	
Applicant name:	Huvepharma EOOD	
Applicant ACN:	N/A	
Summary of use:	For use in veterinary chemical products	
Date of approval:	1 July 2008	
pproval no.:	82339	

Application no.:	42674	
Active constituent/s:	Monensin Sodium	
Applicant name:	Huvepharma EOOD	
Applicant ACN:	N/A	
Summary of use:	For use in veterinary chemical products	
Date of approval:	3 October 2008	
Approval no.:	82345	

Application no.:	45083	
Active constituent/s:	Salinomycin Sodium	
Applicant name:	Phibro Animal Health Pty Limited	
Applicant ACN:	093 869 991	
Summary of use:	For use in veterinary chemical products	
Date of approval:	6 February 2009	
Approval no.:	82370	

Application no.:	41838	
Active constituent/s:	Tylosin Phosphate	
Applicant name:	Huvepharma EOOD	
Applicant ACN:	N/A	
Summary of use:	For use in veterinary chemical products	
Date of approval:	2 October 2009	
Approval no.:	82342	

Application no.:	49225	
Active constituent/s:	Dinitolmide	
Applicant name:	Nutriment Health Pty Ltd	
Applicant ACN:	628 638 300	
Summary of use:	For use in veterinary chemical products	
Date of approval:	8 November 2010	
Approval no.:	82436	

Application no.:	48712	
Active constituent/s:	Glucosamine Hydrochloride	
Applicant name:	RWR Veterinary Products Pty Ltd	
Applicant ACN:	088 423 018	
Summary of use:	For use in veterinary chemical products	
Date of approval:	24 November 2010	
Approval no.:	82107	

Application no.:	49987	
Active constituent/s:	Nicarbazin	
Applicant name:	Nutriment Health Pty Ltd	
Applicant ACN:	628 638 300	
Summary of use:	For use in veterinary chemical products	
Date of approval:	3 December 2010	
Approval no.:	82388	

Application no.:	48753	
Active constituent/s:	Moxidectin	
Applicant name:	Merial Australia Pty Ltd	
Applicant ACN:	071 187 285	
Summary of use:	For use in veterinary chemical products	
Date of approval:	10 February 2011	
Approval no.:	82193	

Application no.:	53352	
Active constituent/s:	Ivermectin	
Applicant name:	RWR Veterinary Products Pty Ltd	
Applicant ACN:	008 423 018	
Summary of use:	For use in veterinary chemical products	
Date of approval:	21 July 2011	
Approval no.:	82361	

Application no.:	53352	
Active constituent/s:	Praziquantel	
Applicant name:	RWR Veterinary Products Pty Ltd	
Applicant ACN:	088 423 018	
Summary of use:	For use in veterinary chemical products	
Date of approval:	21 July 2011	
Approval no.:	82362	

Application no.:	51351	
Active constituent/s:	Flavophospholipol	
Applicant name:	Nutriment Health Pty Ltd	
Applicant ACN:	628 638 300	
Summary of use:	For use in veterinary chemical products	
Date of approval:	25 July 2011	
Approval no.:	82433	

Application no.:	57612	
Active constituent/s:	Robenidine Hydrochloride	
Applicant name:	Nutriment Health Pty Ltd	
Applicant ACN:	628 638 300	
Summary of use:	For use in veterinary chemical products	
Date of approval:	26 August 2012	
Approval no.:	82427	

Application no.:	46158	
Active constituent/s:	Meloxicam	
Applicant name:	Chanelle Animal Health Ltd	
Applicant ACN:	N/A	
Summary of use:	For use in veterinary chemical products	
Date of approval:	28 May 2013	
Approval no.:	82470	

Application no.:	63230	
Active constituent/s:	Bacitracin Zinc	
Applicant name:	Nutriment Health Pty Ltd	
Applicant ACN:	628 638 300	
Summary of use:	For use in veterinary chemical products	
Date of approval:	2 June 2015	
Approval no.:	82424	

Application no.:	54347	
Active constituent/s:	Chlortetracycline Hydrochloride	
Applicant name:	Nutriment Health Pty Ltd	
Applicant ACN:	628 638 300	
Summary of use:	For use in veterinary chemical products	
Date of approval:	8 July 2015	
Approval no.:	82431	

Application no.:	101895	
Active constituent/s:	Praziquantel	
Applicant name:	Virbac (Australia) Pty Ltd	
Applicant ACN:	003 268 871	
Summary of use:	For use in veterinary chemical products	
Date of approval:	27 November 2015	
Approval no.:	80904	

Application no.:	102411	
Active constituent/s:	Abamectin	
Applicant name:	Zoetis Australia Pty Ltd	
Applicant ACN:	156 476 425	
Summary of use:	For use in veterinary chemical products	
Date of approval:	16 December 2015	
Approval no.:	81143	

Application no.:	101377	
Active constituent/s:	Ivermectin	
Applicant name:	Exelpet Products A Div Of Mars Australia Pty Ltd	
Applicant ACN:	008 454 313	
Summary of use:	For use in veterinary chemical products	
Date of approval:	20 January 2016	
Approval no.:	82319	

Application no.:	24620	
Active constituent/s:	Clostridium Perfringens Type D Toxoid (Inactivated)	
Applicant name:	Virbac (Australia) Pty Ltd	
Applicant ACN:	003 268 871	
Summary of use:	For use in veterinary chemical products	
Date of approval:	21 January 2016	
Approval no.:	82177	

Application no.:	24620	
Active constituent/s:	Clostridium Tetani Toxoid (Inactivated)	
Applicant name:	Virbac (Australia) Pty Ltd	
Applicant ACN:	003 268 871	
Summary of use:	For use in veterinary chemical products	
Date of approval:	21 January 2016	
Approval no.:	82178	

Application no.:	24620	
Active constituent/s:	Corynebacterium Pseudotuberculosis (Inactivated)	
Applicant name:	Virbac (Australia) Pty Ltd	
Applicant ACN:	003 268 871	
Summary of use:	For use in veterinary chemical products	
Date of approval:	21 January 2016	
Approval no.:	82179	

Application no.:	102688	
Active constituent/s:	Moxidectin	
Applicant name:	Virbac (Australia) Pty Ltd	
Applicant ACN:	003 268 871	
Summary of use:	For use in veterinary chemical products	
Date of approval:	3 February 2016	
Approval no.:	81254	
2.	Variations of active constituent
Application no.:	103526	
Active constituent/s:	Lincomycin Hydrochloride	
Applicant name:	Zoetis Australia Pty Ltd	
Applicant ACN:	156 476 425	
Summary of variation:	Variation of relevant particulars or conditions of an approved active constituent	
Date of variation:	31 July 2015	
Approval no.:	81641	

Application no.:	101660	
Active constituent/s:	Robenidine Hydrochloride	
Applicant name:	Zoetis Australia Pty Ltd	
Applicant ACN:	156 476 425	
Summary of variation:	Variation of relevant particulars or conditions of an approved active constituent	
Date of variation:	13 January 2016	
Approval no.:	81897	

Application no.:	104265	
Active constituent/s:	Omeprazole	
Applicant name:	Merial Australia Pty Ltd	
Applicant ACN:	071 187 285	
Summary of variation:	Variation of relevant particulars or conditions of an approved active constituent	
Date of variation:	18 January 2016	
Approval no.:	55318	

Application no.:	104256	
Active constituent/s:	Spiramycin	
Applicant name:	Merial Australia Pty Ltd	
Applicant ACN:	071 187 285	
Summary of variation:	Variation of relevant particulars or conditions of an approved active constituent	
Date of variation:	16 February 2016	
Approval no.:	56286	

Application no.:	105359	
Active constituent/s:	Eprinomectin	
Applicant name:	Merial Australia Pty Ltd	
Applicant ACN:	071 187 285	
Summary of variation:	Variation of relevant particulars or conditions of an approved active constituent	
Date of variation:	18 February 2016	
Approval no.:	55471	

Application no.:	103127	
Active constituent/s:	Metribuzin	
Applicant name:	Bayer Cropscience Pty Ltd	
Applicant ACN:	000 226 022	
Summary of use:	For use in agricultural chemical products	
Date of approval:	23 February 2016	
Approval no.:	81441	

Application no.:	103317	
Active constituent/s:	Isoxaflutole	
Applicant name:	Adama Australia Pty. Limited	
Applicant ACN:	050 328 973	
Summary of use:	For use in agricultural chemical products	
Date of approval:	3 March 2016	
Approval no.:	81538	

Application no.:	103070	
Active constituent/s:	Fluioxonil	
Applicant name:	UPL Australia Limited	
Applicant ACN:	066 391 384	
Summary of use:	For use in agricultural chemical products	
Date of approval:	4 March 2016 	
Approval no.:	81424	

Application no.:	103440	
Active constituent/s:	Hexazinone	
Applicant name:	Sanonda (Australia) Pty Ltd	
Applicant ACN:	059 813 973	
Summary of use:	For use in agricultural chemical products	
Date of approval:	8 March 2016	
Approval no.:	81602	

Application no.:	103060	
Active constituent/s:	Clodinafop-propargyl	
Applicant name:	Agrogill Chemicals Pty Ltd	
Applicant ACN:	094 672 107	
Summary of use:	For use in agricultural chemical products	
Date of approval:	9 March 2016	
Approval no.:	81415	

Application no.:	102763	
Active constituent/s:	Prosulfocarb	
Applicant name:	TGAC Australia Pty. Ltd	
Applicant ACN:	134 570 700	
Summary of use:	For use in agricultural chemical products 	
Date of approval:	15 March 2016	
Approval no.:	81296	

APVMA review of maldison—suspension of product and associated labels
This notice is issued under s.45A(1)(b) of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code) and provides notice that the Australian Pesticides and Veterinary Medicines Authority (APVMA) has suspended the registration of product 33018 Nufarm Maldison 500 Insecticide (product 33018) and all associated labels as specified in Table 1 below.
The suspension will be in effect from 15 March 2016 until 1 March 2017.
The suspension will include a phase-out period from 15 March 2016 until 1 March 2017 under the conditions of a deemed permit under s.45B of the Agvet Code, allowing possession, custody, supply and use of the product according to label directions. The deemed permit does not allow manufacture or import of the product. The APVMA declares that after 1 March 2017, s.45B(1) of the the Agvet Code ceases to apply in respect of product 33018 and the permit will not be in force.
Table 1—Details of product registration and label approvals subject to suspension
Product number	Product name	Holder	Label approval(s)	
33018	Nufarm Maldison 500 Insecticide	Nufarm Australia Limited	0100, 0103, 0207, 0402, 0901	
REASONS FOR THE SUSPENSION
The APVMA review of maldison commenced in 2003 due to human health concerns including the potential formation of toxic impurities during storage. As part of the review, the APVMA conducted a chemical stability assessment of product 33018 and determined that the concentration of the toxic impurity, isomalathion, exceeded the safe limit after extended storage, based on Food and Agricultural Organisation of the United Nations (FAO) specifications for maldison (2013). Consequently, it appears to the APVMA that the product does not meet the safety criteria as defined under s5A of the Agvet Code (the safety criteria) as it may:
•	be an undue hazard to the safety of people exposed to it during its handling
•	have an effect that is harmful to human beings.
Under s.41(1)(b) of the Agvet Code, the APVMA may suspend the registration of a chemical product if it appears to the APVMA that the product may not meet the safety criteria. The APVMA may also suspend the approval of a label under s.44(2) of the Agvet Code if the APVMA suspends the registration of the inter-related chemical product. 
Consequently, the APVMA has suspended the registration of product 33018, based on s.41(1)(b) of the Agvet Code, for the reasons outlined above. The APVMA has also suspended all associated label approvals under s.44(2) of the Agvet Code.
Instructions for dealing with the suspended product
The following instructions apply to people dealing with product 33018 during the period of suspension from 15 March 2016 until 1 March 2017:
•	possession, custody, supply and use of product 33018 in accordance with label directions is permitted
•	manufacture or import of product 33018 is not permitted. 

Warning
From 15 March 2016 until 1 March 2017, under s.45C(2) of the Agvet Code, a person may only possess, have custody of or otherwise deal with product 33018 in accordance with the instructions contained in this notice. Failure to comply with the instructions contained in this notice is an offence which attracts a fine of 300 penalty units as specified under s.45C(5) of the Agvet Code. 
The APVMA may undertake further regulatory actions for product 33018 during the suspension period which may impact the suspension conditions.
APVMA Contact
For further information please contact:
Chemical Review Liaison Officer
Scientific Assessment and Chemical Review
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4749
Fax:	+61 2 6210 4776
Email:	chemicalreview@apvma.gov.au

This content is subject to an erratum to be published in Gazette No. 7, 5 April 2016. 
The correct title is ‘New active constituent—bixafen’
New veterinary active constituent—bixafen
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new active constituent, bixafen for use as a fungicide in agricultural products.
Common Name	Bixafen	
IUPAC Name:	N-(3',4'-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide	
Chemical Abstracts Name:	N-(3′,4′-dichloro-5-fluoro[1,1′-biphenyl]-2-yl)-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide	
CAS Number:	581809-46-3	
Molecular Formula:	C18H12Cl2F3N3O	
Molecular Weight:	414.21	
Structure:		
Chemical Family:	Anilide fungicide and pyrazole fungicide	
Mode of Action:	Inhibition of mitochondrial function by disrupting complex II (succinate dehydrogenase) in the respiratory electron transport chain	
Summary of the APVMA’s Evaluation of Bixafen Active Constituent
The Scientific Assessment and Chemical Review Program of the APVMA has evaluated the chemistry aspects of bixafen active constituent (manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.
The Office of Chemical Safety has considered the toxicological aspects of bixafen, and advised that there are no objections on toxicological grounds to the approval of the active constituent bixafen. An Acceptable Daily Intake (ADI) of 0.02 mg/kg bw/d and an Acute Reference Dose (ARfD) of 0.2 mg/kg bw have been set. On 27 November 2015, the Delegate to the Secretary of the Department of Health published a final scheduling decision to create a new Schedule 5 entry for bixafen in the Standard for the Uniform Scheduling of Medicines and Poisons, with no exemption cut-off, and an implementation date of 1 February 2016.
The APVMA accepts the findings and recommendations of its adviser on these criteria.
The APVMA is satisfied that the proposed importation and use of bixafen 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 sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for approval of bixafen should be granted. Submissions should relate only to matters that the APVMA is required by legislation to consider in deciding whether to grant the approval. These grounds include chemistry and manufacture, and toxicity. Submissions should state the grounds on which they are based. Comments received outside these grounds cannot be considered by the APVMA. 
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post. A summary of relevant comments and the APVMA’s response will be published on the APVMA website. 
When making a submission please include a:
•	contact name
•	company or group name (if relevant)
•	postal address
•	email address (if available)
•	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 approval for bixafen that relate to the grounds for approval should be addressed in writing to: 
Director of Chemistry and Manufacture
Scientific Assessment and Chemical Review Program 
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 

This content is subject to an erratum to be published in Gazette No. 7, 5 April 2016. 
The correct applicant name is Bayer CropScience Pty Ltd. Product use information has been corrected to remove application on barley, oats, triticale and wheat and minor typographical errors have been corrected.
New agricultural chemical products bixafen in aviator xpro foliar fungicde
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Sumitomo Chemical Australia Pty Ltd for registration of a new product containing the new active bixafen and the existing active constituent prothioconazole. The product Aviator Xpro Foliar Fungicide is for use on canola.
Particulars of The Application
Proposed Product Name(s):	AVIATOR XPRO FOLIAR FUNGICIDE	
Applicant Company:		
Name of Active Constituent:	Bixafen	
Signal Heading:		
Summary of Proposed Use:	For the control of black leg (Leptosphaeria maculans)) in canola	
Pack Sizes:	10 L, 15 L, 10 L, 20 L, 100 L, 110 L and 1000 L
	
Withholding Period:	Harvest: Not required when used as directed
Grazing: Livestock Not Producing Milk for Human Consumption: Do not graze or cut for stock food for 4 weeks after application.
Livestock Producing milk for Human Consumption: Do not graze livestock producing milk for human consumption on treated crops.
	
Summary of the APVMA’s evaluation of Aviator xpro foliar Fungicide in accordance with Section 14(3)(e) and (f) of the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994
The APVMA has evaluated the application and in its assessment in relation to human and environmental safety under section 14(3)(e) of the Agvet Code, it proposes to determine that:
(i)	The APVMA is satisfied that the proposed use of AVIATOR XPRO FOLIAR FUNGICIDE 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 and Ageing has conducted a risk assessment on the product and concluded that it can be used safely. 
Aviator Xpro Foliar Fungicide is intended only for professional use, and farmers and their employees will be the main users of the product. The product will be applied by various ground boom or aerial applications. Workers may be exposed to the product when opening containers, mixing/loading, application, cleaning up spills, maintaining equipment and entering treated crops. The main routes of exposure to the product spray will be dermal and inhalation, with possible ocular exposure.
In the absence of exposure data for bixafen and for the proposed aerial mode of application for prothioconazole, the Pesticide Handler Exposure Database (PHED) Surrogate Exposure Guide was used to estimate exposure. The database was also used to verify the calculated exposure of workers to prothioconazole via ground boom application from submitted exposure studies.
Estimated exposures to the product when preparing and using the spray by ground boom or aerial application were at acceptable levels when wearing personal protective equipment (PPE). Based on the risk assessment, First Aid Instructions, Safety Directions and Re-entry statements have been recommended for the product label. 
Based on the risk assessment, First Aid Instructions, Safety Directions and Re-entry statements have been recommended for the product label. 
Based on an assessment of the toxicology, it was considered that there should be no adverse effects on human health from the use of Aviator Xpro Foliar Fungicide when used in accordance with the label directions.
(ii)	The APVMA is satisfied that the proposed use of AVIATOR XPRO FOLIAR will not be an undue hazard to the safety of people using anything containing its residues.
The product will be used as a foliar spray canola. The APVMA Residues and Trade Section has evaluated the residues aspects of the proposed product and has recommended amendments to the APVMA MRL Standard for bixafen and for inclusion in the Food Standards Code. Dietary intake modelling has shown the expected chronic and acute dietary exposures to bixafen are both below the relevant health standards. Recommendations in regard to the withholding period and protection statements for livestock have been included on the label.
The APVMA is satisfied that the proposed use of AVIATOR XPRO FOLIAR FUNGICIDE containing the active constituents bixafen and prothioconazole is not likely to be harmful to human beings if used according to the product label.
Bixafen is a carboxamide fungicide belonging to the sub-class of the pyrazole-carboxamides, a succinate dehydrogenase inhibitor of fungal pathogens. The proposed use of a new emulsifiable concentrate product, Aviator Xpro Foliar Fungicide, containing bixafen at 75 g/L and prothioconazole at 150 g/L, is for the control and/or suppression of foliar diseases in barley, oats, triticale, wheat and canola. Aviator Xpro Foliar Fungicide will be available in pack sizes between 10 and 1000 L. 
In toxicokinetics studies in rats, bixafen was absorbed rapidly and overall oral absorption was high. After absorption, bixafen was widely distributed and detected, at low concentrations, in most examined tissues. Elimination of absorbed bixafen was rapid, with the majority of the administered radioactivity eliminated in faeces within the first 24 hours. Bixafen was highly metabolised with only approximately 9 % was excreted in the unchanged form. 
Based on the findings of the acute toxicological studies evaluated, bixafen has low acute oral, dermal and inhalational toxicity in rats. Bixafen is not a skin or eye irritant in rabbits. No determination on whether bixafen is a skin sensitiser could be made, as a guideline-compliant skin sensitisation study was not provided. 
Bixafen was generally well tolerated across the species tested in repeat-dose toxicity studies, with decreases in body weight and body weight gain identified along with increases in liver weights, with associated histopathological changes, as the main treatment-related effects. Carcinogenicity studies indicated that bixafen was not carcinogenic in mice or rats. Bixafen was negative in in vitro and in vivo mutagenicity and/or genotoxicity studies. 
Bixafen was not a reproductive or developmental toxicant, as measured reproductive and developmental indices, including malformation/variation frequencies, were only seen at doses that showed significant maternal toxicity. Across acute and subchronic studies, bixafen was not a neurotoxicant.
Based on the findings of the acute toxicological studies evaluated, the product Aviator Xpro Foliar Fungicide has low acute oral and dermal toxicity in rats and has low estimated inhalational toxicity. Aviator Xpro Foliar Fungicide was a severe eye and a slight skin irritant in rabbits, and was not a skin sensitiser in mice (LLNA method).
Based on an assessment of the toxicology, it was considered that there should be no adverse effects on human health from the use of Aviator Xpro Foliar Fungicide when used in accordance with the label directions.
(iii)	The APVMA is satisfied that the proposed use of AVIATOR XPRO FOLIAR FUNGICIDE containing the active constituents bifaxen and prothioconazole is not likely to have an unintended effect that is harmful to animals, plants or the environment if used according to the product label directions.
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 provided that the draft label is updated to meet current spray drift requirements. 
Bixafen is stable to hydrolysis and photolytic degradation. It is persistent in the terrestrial environment with field half-lives potentially exceeding 1000 days. However, it is not expected to be mobile in soil. When released to water, bixafen may be expected to partition to the sediments where again, it is likely to be very persistent. Bixafen is not likely to bio-accumulate. 
Bixafen is practically non-toxic to birds based on acute and dietary exposure. No effects on avian reproduction are expected based on application rates and uses assessed. It was found to be very highly toxic to fish and moderately toxic to aquatic invertebrates based on both acute and chronic exposure.
Bixafen was very highly toxic to two of four standard algal test species and was at worst highly toxic to the standard floating aquatic macropyte, Lemna gibba. 
Bixafen generally did not exhibit toxicity towards terrestrial invertebrates or soil microorganisms at levels expected through the proposed use pattern. Tier 1 testing using the formulated end-use product showed some terrestrial plants were potentially based on growth measurements, but mortality was not observed at use rates higher than those currently proposed.
In spite of conservative modelling, the risk assessment determined that the chemical is unlikely to pose an environmental risk under the proposed use pattern, provided the draft label is updated to meet current requirements, and appropriate down-wind spray drift buffer zones are implemented for the protection of sensitive aquatic and terrestrial areas. 
The APVMA has considered these findings accepts these conclusions.
(iv)	The APVMA is considering whether the proposed use of AVIATOR XPRO FOLAIR FUNGICDE would not adversely affect trade between Australia and places outside Australia.
Export of treated produce containing finite (measurable) residues of bixafen and prothioconazole may pose a risk to Australian trade in situations where (i) no residue tolerance (import tolerance) is established in the importing country or (ii) where residues in Australian produce are likely to exceed a residue tolerance (import tolerance) established in the importing country. 
No changes to established prothioconazole MRLs for rape seed and animal commodities are proposed and therefore the proposed use of prothioconazole is unlikely to increase the risk to international trade.
The proposed residue definition for bixafen is the same as that established by Codex, the EU and New Zealand. International MRLs have not been established for bixafen by Codex, the USA, Korea and Taiwan.
An MRL for canola is proposed at the LOQ (*0.01 mg/kg) and therefore the export of treated canola is unlikely to result in an undue risk to international trade. 
Bixafen MRLs for meat [mammalian] [in the fat] and edible offal (Mammalian) at 0.1 and 0.3 mg/kg respectively are required for the proposed use on canola. The proposed Export Slaughter Interval of 7 days should adequately prevent residues above the LOQ of 0.02 mg/kg in animal commodities destined for export.
The following label statements have been proposed to manage the trade risk associated with the proposed use:
 ‘EXPORT OF TREATED PRODUCE: Growers should note that MRLs or import tolerances do not exist in all markets for produce treated with Aviator Xpro. If you are growing produce for export, please check with Bayer CropScience for the latest information on MRLs and import tolerances before using Aviator Xpro’, and, ‘EXPORT SLAUGHTER INTERVAL (ESI—7 DAYS: Livestock not producing milk for human consumption that have been grazing on treated crops should be placed on clean feed for 7 days prior to slaughter’).
Comment is sought from the relevant industry groups on the perceived level of risk and whether any industry-initiated strategies are required to manage that risk. 
(v)	In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials supporting the efficacy of the product adequately demonstrate that if used according to the product label directions, the product is effective for its proposed uses.
FuRther Information
A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Public Consultation’ page, or by contacting the APVMA via the details listed below.
Making a Submission
In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for registration of AVIATOR XPRO FOLIAR FUNGICIDE should be granted. Submissions should relate only to matters that the APVMA is required by legislation to take into account in deciding whether to grant the application. These grounds include occupational health and safety, chemistry and manufacture, residues, safety and first aid, environmental fate and toxicity, trade and efficacy. Submissions should state the grounds on which they are based. Comments received outside these grounds cannot be considered by the APVMA. 
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post. 
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 a:
•	contact name
•	company or group name (if relevant)
•	email or postal address
•	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 Evaluation
Registration Management and Evaluation
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4700
Fax:	+61 2 6210 4776
Email:	enquiries@apvma.gov.au

Final pesticide and veterinary medicines product sales 2014–15 financial year 
This notice provides the collated final product sales information provided to the APVMA for the 2014–15 financial year. 
AGRICULTURAL (PESTICIDES) PRODUCT SALES FOR THE 2014–15 FINANCIAL YEAR
AGRICULTURAL PRODUCT TYPES	NO OF PRODUCTS	TOTAL $	
ADJUVANTS/SURFACTANTS	424	80,014,340.00	
ANTIFOULING—BOAT	48	17,227,430.00	
DAIRY CLEANSER	133	12,573,155.00	
DISINFECTANT/SANITISER	104	10,193,093.00	
FUNGICIDE	959	206,610,557.00	
GROWTH PROMOTERS/REGULATORS	243	30,144,204.00	
HERBICIDE	3119	1,545,493,477.00	
HOUSEHOLD INSECTICIDE	588	141,589,433.00	
INSECTICIDE	1514	332,456,018.00	
MISC(E.G: SEED SAFENERS, MARKERS ETC)	51	4,888,882.00	
MITICIDE	128	20,860,763.00	
MIXED FUNCTION PESTICIDE	219	71,744,276.00	
MOLLUSCICIDE	53	15,569,949.00	
NEMATICIDE	18	3,904,630.00	
POOL PRODUCTS/ALGICIDE	757	63,705,670.00	
REPELLENTDOGS/BIRDS ETC	18	1,224,072.00	
SEED TREATMENTS	64	8,130,289.00	
VERTEBRATE POISON	217	18,471,093.00	
WOOD PRESERVATIVE	16	2,870,360.00	
GRAND TOTAL	8673	2,587,671,691.00	

VETERINARY MEDICINES PRODUCT SALES FOR THE 2014–15 FINANCIAL YEAR
VETERINARY PRODUCT TYPES	 	NO OF PRODUCTS	TOTAL $	
ALIMENTARY SYSTEM	ANTI BLOAT	17	1,791,473.00	
ALIMENTARY SYSTEM	ANTIDIARRHOEALS AND SCOUR TREATMENTS	17	1,409,472.00	
ALIMENTARY SYSTEM	LAXATIVES, PURGATIVES & LUBICANTS, ANTISPASMODICS	14	2,290,657.00	
ANAESTHETICS/ANALGESICS	ANAESTHETICS—LOCAL AND GENERAL	51	11,577,854.00	
ANAESTHETICS/ANALGESICS	ANALGESICS	19	4,887,581.00	
ANTIBIOTIC & RELATED	ANTIBIOTIC—INTRAMAMMARY	28	11,217,459.00	
ANTIBIOTIC & RELATED	ANTIBIOTIC—ORAL	200	25,995,462.00	
ANTIBIOTIC & RELATED	ANTIBIOTIC—PARENTERAL	79	28,038,113.00	
ANTIBIOTIC & RELATED	OTHER ANTI-INFECTIVE AGENTS	46	1,682,589.00	
ANTIBIOTIC & RELATED	SULFONAMIDES	40	2,922,236.00	
ANTIDOTES	ANTIDOTES	16	1,302,556.00	
CARDIOVASCULAR SYSTEM	CARDIAC REACTANTS, CLOTTING AGENTS	43	7,345,104.00	
CENTRAL NERVOUS SYSTEM	HYPNOTICS, TRANQUILIZERS, EMETICS, ANTIEMETICS	43	4,645,783.00	
DERMATOLOGICAL PREPS.	ANTIBIOTICS, ANTIFUNGALS, CORTICOSTEROID COMBINATIONS	30	2,572,941.00	
DERMATOLOGICAL PREPS.	ANTISEPTICS (DERMATOLOGICAL AND GENERAL)	139	24,210,888.00	
DERMATOLOGICAL PREPS.	NONSTEROIDAL ANTIPRURITICS, KERATOLYICS	36	5,556,013.00	
EAR,NOSE,THROAT PREPS.	AURAL	27	6,434,754.00	
ENDOCRINE SYSTEM	ANABOLIC STEROIDS	21	174,256.00	
ENDOCRINE SYSTEM	CORTICOSTEROIDS AND ADRENAL COMPOUNDS	32	3,272,236.00	
ENDOCRINE SYSTEM	SEX HORMONES	56	9,233,990.00	
ENDOCRINE SYSTEM	TROPIC HORMONES (PITUITARY) & INSULIN PREPARATIONS	37	6,309,977.00	
GENITOURINARY SYSTEM	DIURETICS, ACIDIFIERS, ALKANISERS	27	1,612,727.00	
GENITOURINARY SYSTEM	UTERINE OR VAGINAL ACTING AGENTS	7	1,070,336.00	
IMMUNOTHERAPY	ANTISERA, ANTIVENIM	9	2,647,060.00	
IMMUNOTHERAPY	IMMUNOMODIFYING AGENTS	11	2,523,090.00	
IMMUNOTHERAPY	INJECTABLE VACCINES	177	134,775,418.00	
IMMUNOTHERAPY	NASAL, ORAL, OPTHALMIC VACCINES	34	26,856,036.00	
MISC	MISC	92	21,672,580.00	
MUSCULOSKELETAL SYSTEM	ANTI-INFLAMMATORY AGENTS	236	30,667,346.00	
MUSCULOSKELETAL SYSTEM	COUNTER-IRRITANTS, RUBEFACIENTS, POULTICES	16	2,712,813.00	
NUTRITION & METABOLISM	ANTIBIOTIC AND ANTI-INFECTIVE SUPPLEMENTS	47	4,086,166.00	
NUTRITION & METABOLISM	DIETARY/THERAPEUTIC PET FOODS	147	51,606,194.00	
NUTRITION & METABOLISM	DIGESTIVE ENZYME SUPPLEMENTS	78	14,670,986.00	
NUTRITION & METABOLISM	ELECTROLYTES	71	4,864,031.00	
NUTRITION & METABOLISM	GROWTH PROMOTANTS	66	22,823,595.00	
NUTRITION & METABOLISM	IRON AND HAEMOPOIETIC AGENTS	24	1,391,344.00	
NUTRITION & METABOLISM	PROBIOTIC AND PREBIOTIC	25	1,790,699.00	
NUTRITION & METABOLISM	TONICS, STIMULANTS	13	365,076.00	
NUTRITION & METABOLISM	VITAMIN, MINERAL, & NUTRITIONAL SUPPLEMENTS	226	31,044,170.00	
OPHTHALMIC PREPARATIONS	OPHTHALMIC PREPARATIONS	21	2,247,854.00	
PARASITICIDES	BIRDS—EXTERNAL	12	335,106.00	
PARASITICIDES	BIRDS—INTERNAL	30	2,736,734.00	
PARASITICIDES	LARGE & SMALL ANIMALS—EXTERNAL	18	2,062,593.00	
PARASITICIDES	LARGE ANIMALS—EXTERNAL	193	68,050,511.00	
PARASITICIDES	LARGE ANIMALS—INTERNAL	285	55,081,482.00	
PARASITICIDES	LARGE ANIMALS—INTERNAL & EXTERNAL	96	54,881,156.00	
PARASITICIDES	SMALL ANIMALS—EXTERNAL	227	108,580,997.00	
PARASITICIDES	SMALL ANIMALS—INTERNAL	263	81,753,386.00	
PARASITICIDES	SMALL ANIMALS INTERNAL AND EXTERNAL	39	57,785,403.00	
RESPIRATORY SYSTEM	EXPECTORANTS, MUCOLYTICS, DECONGESTANTS, BRONCHODILATORS, RESP STIMULANTS	20	1,297,823.00	
GRAND TOTAL	 	3501	954,864,106.00	
APVMA Contact
For further information please contact:
Finance 
Corporate Services
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4808
Fax:		+61 2 6210 4874
Email:	finance@apvma.gov.au