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No. APVMA 13, Tuesday, 30 June 2015
Published by The Australian Pesticides and Veterinary Medicines Authority
AGRICULTURAL AND
VETERINARY CHEMICALS
The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995.
The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be
published in the Gazette containing details of the registration of agricultural and veterinary chemical products and
other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code and
related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet Codes
in this publication is a reference to the Agvet Code in each state and territory jurisdiction.
ISSN 1837 - 7629
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 2
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 grant ed 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 activ ity in
quarterly statistical reports.
DISTRIBUTION AND SUBSCRIPTION
The APVMA Gazette is published in electronic format only and is available from the APVMA website,
www.apvma.gov.au/publications/gazette/.
If you would like to receive email notification when a new edition is published, please subscribe on the APVMA website.
APVMA CONTACTS
For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4870
For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Erratum Notice ................................................................................................................................................................ 3 Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and Approved Labels .................................................................................................... 14 Approved Active Constituents ....................................................................................................................................... 20 Fluensulfone in the product Nimitz 480 EC Nematicide ................................................................................................ 21
Erratum Notice
The Australian Pesticides and Veterinary Medicines Authority advises that an error was published in the Commonwealth
of Australia Gazette for Agricultural and Veterinary Chemicals, No. APVMA 1, Tuesday, 13 January 2015
In the Notice, the active constituent under ATLAS Flying Insect Spray Fast Knockdown Hypoallergenic Fragrance was
incorrectly stated as 1.1 g/kg esbiothrin. The correct amount is 1.26 g/kg esbiothrin.
The correct entry for the Notice of Registration for ATLAS Flying Insect Spray Fast Knockdown Hypoallergenic
Fragrance is on page 4 of this Gazette.
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 4
Agricultural Chemical Products and Approved Labels
Agricultural Chemical Products and Approved Labels
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals
Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of
the registration in respect of the following products and has approved the label or varied the relevant particulars or
conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.: 100113
Product name: ATLAS Flying Insect Spray Fast Knockdown Hypoallergenic Fragrance
Active constituent/s: 1.26 g/kg esbiothrin, 0.5 g/kg permethrin
Applicant name: Pascoe's Pty Ltd
Applicant ACN: 055 220 463
Summary of use For use as a household insecticide to control a range of flying and crawling insects
Date of registration/approval: 16 December 2014
Product registration no.: 80044
Label approval no.: 80044/100113
Application no.: 101090
Product name: General 100 EC Insect Growth Regulator
Active constituent/s: 100 g/L pyriproxyfen
Applicant name: Aako Australia Pty Limited
Applicant ACN: 122 279 109
Summary of use For the control of silverleaf whitefly (Bemisia tabaci Biotype B) in cotton, rockmelon and capsicum, the control of silverleaf whitefly (Bemisia tabaci Biotype B) and greenhouse
whitefly in tomatoes
Date of registration/approval: 11 June 2015
Product registration no.: 80549
Label approval no.: 80549/101090
Application no.: 100969
Product name: Ruby 100 EC Systemic Fungicide
Active constituent/s: 100 g/L penconazole
Applicant name: Agritrading Pty Limited
Applicant ACN: 134 291 295
Summary of use For the control black spot (apple scab and pear scab) of apples and pears, powdery mildew
of apples and grapes and ring spot of brussel sprouts
Date of registration/approval: 12 June 2015
Product registration no.: 80499
Label approval no.: 80499/100969
Application no.: 102014
Product name: Farmalinx Metalax G Fungicide
Active constituent/s: 50 g/kg metalaxyl
Applicant name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of use For control of phytophthora root rot of avocados, phytophthora root rot and trunk canker of macadamia nuts, phytophthora trunk rot of peaches, damping off of certain vegetable crops
Date of registration/approval: 12 June 2015
Product registration no.: 80965
Label approval no.: 80965/102014
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 5
Agricultural Chemical Products and Approved Labels
Application no.: 62045
Product name: Aimco Tree And Blackberry Killer
Active constituent/s: 50 g/L triclopyr present as butoxyethanol ester
Applicant name: Aimco KR Australia Pty Ltd
Applicant ACN: 145 929 924
Summary of use For the control of hard-to-kill weeds and trees in the home garden
Date of registration/approval: 12 June 2015
Product registration no.: 69908
Label approval no.: 69908/62045
Application no.: 62829
Product name: Goliath Liquid Ant Bait
Active constituent/s: 0.6 g/L fipronil
Applicant name: BASF Australia Ltd
Applicant ACN: 008 437 867
Summary of use For control of ants in and around domestic, commercial and institutional buildings
Date of registration/approval: 12 June 2015
Product registration no.: 70252
Label approval no.: 70252/62829
Application no.: 101449
Product name: Apparent Pound 240 Herbicide
Active constituent/s: 240 g/L carfentrazone-ethyl
Applicant name: Apparent Pty. Ltd.
Applicant ACN: 143 724 136
Summary of use For the control of marshmallow and certain other broadleaf weeds prior to establishment of broadacre crops, fallow or forest plantations, in commercial, industrial, and public service areas, around agricultural buildings and yards and other situations
Date of registration/approval: 15 June 2015
Product registration no.: 80696
Label approval no.: 80696/101449
Application no.: 101364
Product name: Ratshot-G Rodenticide Grain Bait
Active constituent/s: 0.05 g/kg difenacoum
Applicant name: Freezone Public Health Pty Ltd
Applicant ACN: 132 080 098
Summary of use For the control of brown or norway rats and mice for use in and around buildings and domestic dwellings
Date of registration/approval: 15 June 2015
Product registration no.: 80667
Label approval no.: 80667/101364
Application no.: 101084
Product name: Plant Doctor's Natural Plant, Garden & Indoor Insecticide
Active constituent/s: 880 g/kg diatomaceous earth, 2 g/kg pyrethrins, 10 g/kg piperonyl butoxide
Applicant name: Grow Choice Pty Limited
Applicant ACN: 069 839 961
Summary of use Control of insect pests in the home garden and in the home
Date of registration/approval: 16 June 2015
Product registration no.: 80546
Label approval no.: 80546/101084
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 6
Agricultural Chemical Products and Approved Labels
Application no.: 101734
Product name: AC Difnil 275 EC Herbicide
Active constituent/s: 250 g/L bromoxynil present as the octanoate, 25 g/L diflufenican
Applicant name: Axichem Pty Ltd
Applicant ACN: 131 628 594
Summary of use For the control of certain broadleaf weeds in winter cereals and pasture
Date of registration/approval: 17 June 2015
Product registration no.: 80824
Label approval no.: 80824/101734
Application no.: 101379
Product name: Eureka! Isoxaflutole 750 WG Herbicide
Active constituent/s: 750 g/kg isoxaflutole
Applicant name: Eureka! Agresearch Pty Ltd
Applicant ACN: 086 194 738
Summary of use For use in the control of various broadleaf weeds and grasses in sugarcane and chickpeas
Date of registration/approval: 18 June 2015
Product registration no.: 80675
Label approval no.: 80675/101379
Application no.: 102096
Product name: Protect-us Aquavate Mosquito Growth Regulator
Active constituent/s: 12 g/kg (S)-methoprene
Applicant name: Ensystex Australasia Pty Ltd
Applicant ACN: 102 221 965809
Summary of use For the prevention of adult mosquito emergence in aquatic situations
Date of registration/approval: 18 June 2015
Product registration no.: 80999
Label approval no.: 80999/102096
Application no.: 62725
Product name: Apollini 540 K Herbicide
Active constituent/s: 540 g/L glyphosate present as the potassium salt
Applicant name: Alpha Crop Protection Pty Ltd
Applicant ACN: 165 653 047
Summary of use For the control of many annual and perennial weeds
Date of registration/approval: 18 June 2015
Product registration no.: 70204
Label approval no.: 70204/62725
Application no.: 63309
Product name: Imtrade Carfentrazone-ethyl 240 EC Herbicide
Active constituent/s: 240 g/L carfentrazone-ethyl
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of use For the control of a range of broadleaf weeds in various situations in combination with other knockdown herbicides
Date of registration/approval: 18 June 2015
Product registration no.: 70372
Label approval no.: 70372/63309
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 7
Agricultural Chemical Products and Approved Labels
Application no.: 102015
Product name: Baracuda Duck Gone
Active constituent/s: 100 g/L benzalkonium chloride, 23.5 g/L alcohol ethoxylate
Applicant name: Zodiac Group Australia Pty Ltd
Applicant ACN: 002 641 965
Summary of use To assist with discouraging ducks from entering swimming pools
Date of registration/approval: 19 June 2015
Product registration no.: 80966
Label approval no.: 80966_102015
Application no.: 102019
Product name: Baracuda Spa Bromine Tablets
Active constituent/s: 650 g/kg available bromine and 280 g/kg available chlorine (Cl) present as bromochlorodimethylhydantoin
Applicant name: Zodiac Group Australia Pty Ltd
Applicant ACN: 002 641 965
Summary of use For killing and controlling algae and bacteria in spas
Date of registration/approval: 19 June 2015
Product registration no.: 80970
Label approval no.: 80970/102019
Application no.: 102068
Product name: Baracuda Pool Algaecide
Active constituent/s: 150 g/L benzalkonium chloride
Applicant name: Zodiac Group Australia Pty Ltd
Applicant ACN: 002 641 965
Summary of use For the control of algae in swimming pools
Date of registration/approval: 19 June 2015
Product registration no.: 80986
Label approval no.: 80986/102068
Application no.: 101673
Product name: AC Ruffle Herbicide
Active constituent/s: 420 g/L MCPA present as potassium salt 26 g/L picloram present as potassium salt
Applicant name: Axichem Pty Ltd
Applicant ACN: 131 628 594
Summary of use For the control of climbing buckwheat, common sowthistle, skeleton weed, capeweed, doublegee and other broadleaf weeds in winter cereals and linseed crops
Date of registration/approval: 19 June 2015
Product registration no.: 80798
Label approval no.: 80798/101673
Application no.: 62338
Product name: CSA Algae Killer
Active constituent/s: 28 g/L copper (Cu) present as copper sulphate pentahydrate, 20 g/L benzalkonium chloride
Applicant name: Chemical Systems Australia Pty Ltd
Applicant ACN: 080 680 039
Summary of use For the control of algae in swimming pools
Date of registration/approval: 19 June 2015
Product registration no.: 70032
Label approval no.: 70032/62338
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 8
Agricultural Chemical Products and Approved Labels
Application no.: 62343
Product name: CSA Algae Killer
Active constituent/s: 32 g/L copper (Cu) present as copper sulphate pentahydrate
Applicant name: Chemical Systems Australia Pty Ltd
Applicant ACN: 080 680 039
Summary of use For the control of algae in swimming pools
Date of registration/approval: 19 June 2015
Product registration no.: 70037
Label approval no.: 70037/62343
Application no.: 102081
Product name: Baracuda Algae Killer
Active constituent/s: 40 g/L copper (CU) present as cupric ammonium complex
Applicant name: Zodiac Group Australia Pty Ltd
Applicant ACN: 002 641 965
Summary of use For controlling algae in swimming pools
Date of registration/approval: 22 June 2015
Product registration no.: 80990
Label approval no.: 80990/102081
Application no.: 102063
Product name: Spalding Dicamba 500 Selective Herbicide
Active constituent/s: 500 g/L dicamba (present as the dimethylamine salt)
Applicant name: Spalding Holdings Pty. Ltd.
Applicant ACN: 010 155 852
Summary of use For the control of certain broadleaf weeds in a variety of situations
Date of registration/approval: 22 June 2015
Product registration no.: 80984
Label approval no.: 80984/102063
Application no.: 62486
Product name: Pendant Herbicide + Fertiliser 12–5–14
Active constituent/s: 5 g/kg pendimethalin
Applicant name: Amgrow Pty Ltd
Applicant ACN: 100 684 786
Summary of use For the pre-emergent control of winter grass, summer grass and crowsfoot in turf
Date of registration/approval: 22 June 2015
Product registration no.: 70092
Label approval no.: 70092/62486
Application no.: 63385
Product name: Kincho Powder Betacyfluthrin 1.5 Insecticide Dust
Active constituent/s: 1.5 g/kg betacyfluthrin
Applicant name: Shanghai Shengnong International Co., Ltd
Applicant ACN: N/A
Summary of use For control of ants in household situations
Date of registration/approval: 22 June 2015
Product registration no.: 70404
Label approval no.: 70404/63385
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 9
Agricultural Chemical Products and Approved Labels
Application no.: 101761
Product name: AC Mepipower 38 Cotton Growth Regulator
Active constituent/s: 38 g/L mepiquat (present as the chloride)
Applicant name: Axichem Pty Ltd
Applicant ACN: 131 628 594
Summary of use For the management of fruiting and excessive vegetative growth in cotton
Date of registration/approval: 23 June 2015
Product registration no.: 80837
Label approval no.: 80837/101761
Application no.: 101677
Product name: AC Dissaray Herbicide
Active constituent/s: 340 g/L MCPA (present as the dimethylamine salt), 80 g/L dicamba (present as the dimethylamine salt)
Applicant name: Axichem Pty Ltd
Applicant ACN: 131 628 594
Summary of use For control of certain broadleaf weeds
Date of registration/approval: 23 June 2015
Product registration no.: 80800
Label approval no.: 80800/101677
Application no.: 101616
Product name: AC Methoate 290 Insecticide
Active constituent/s: 290 g/L omethoate (an anticholinesterase compound)
Applicant name: Axichem Pty Ltd
Applicant ACN: 131 628 594
Summary of use For control of redlegged earth mite, blue oat mite and lucerne flea on pastures, cereals, oilseed and legume crops and control of bluegreen aphid and cowpea aphid on pasture legumes, lucerne, faba beans and vetch
Date of registration/approval: 23 June 2015
Product registration no.: 80778
Label approval no.: 80778/101616
2. VARIATIONS OF REGISTRATION
Application no: 102562
Product name: Pool Pro Blackspot Algaecide
Active constituent/s: 32 g/L copper present as a complex blend of copper salts, 200 g/L benzalkonium chloride
Applicant name: The Pops Group Pty Ltd
Applicant ACN: 095 828 461
Summary of variation: To change the distinguishing name and the name that appears on the label from ‘POOL PRO BLACK SPOT REMOVER’ to ‘POOL PRO BLACKSPOT ALGAECIDE’
Date of variation: 12 May 2015
Product registration no.: 56320
Label approval no.: 56320/102562
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 10
Agricultural Chemical Products and Approved Labels
Application no: 102717
Product name: Apparent Bow Saw 600 Herbicide
Active constituent/s: 600 g/kg metsulfuron-methyl
Applicant name: Apparent Pty. Ltd
Applicant ACN: 143 724 136
Summary of variation: To change the distinguishing name of the product and the name that appears on the label from ‘APPARENT METSULFURON 600 WG HERBICIDE’ to ‘APPARENT BOW SAW 600 HERBICIDE’
Date of variation: 21 May 2015
Product registration no.: 65114
Label approval no.: 65114/102717
Application no: 102720
Product name: Apparent Purge 450 IPA Herbicide
Active constituent/s: 450 g/L 2,4-D present as the isopropylamine salt
Applicant name: Apparent Pty. Ltd
Applicant ACN: 143 724 136
Summary of variation: To change the distinguishing name and the name that appears on the label from ‘APPARENT 2,4-D 450 IPA HERBICIDE’ to ‘APPARENT PURGE 450 IPA HERBICIDE’
Date of variation: 21 May 2015
Product registration no.: 69060
Label approval no.: 69060/102720
Application no: 102723
Product name: Velpar DF Herbicide
Active constituent/s: 750 g/kg hexazinone
Applicant name: Bayer Cropscience Pty Ltd
Applicant ACN: 000 226 022
Summary of variation: To change the distinguishing name and the name that appears on the label from ‘DUPONT VELPAR DF HERBICIDE’ to ‘VELPAR DF HERBICIDE’
Date of variation: 22 May 2015
Product registration no.: 48481
Label approval no.: 48481/102723
Application no: 102761
Product name: Oust Herbicide
Active constituent/s: 750 g/kg sulfometuron-methyl
Applicant name: Bayer Cropscience Pty Ltd
Applicant ACN: 000 226 022
Summary of variation: To change the distinguishing name and the name that appears on the label from ‘DUPONT OUST HERBICIDE’ to ‘OUST HERBICIDE’
Date of variation: 25 May 2015
Product registration no.: 31863
Label approval no.: 31863/102761
Application no: 102787
Product name: Pool Algaecide MSA Extreme
Active constituent/s: 40 g/L copper present as copper sulfate pentahydrate
Applicant name: Biolab Australia Pty Ltd
Applicant ACN: 005 878 017
Summary of variation: To change the distinguishing name and the name that appears on the label from ‘POOL ALGAECIDE BANISH’ to ‘POOL ALGAECIDE MSA EXTREME’
Date of variation: 26 May 2015
Product registration no.: 70178
Label approval no.: 70178/102787
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 11
Agricultural Chemical Products and Approved Labels
Application no: 102785
Product name: Ametrex 800 WG Herbicide
Active constituent/s: 800 g/kg ametryn
Applicant name: Adama Australia Pty Limited
Applicant ACN: 050 328 973
Summary of variation: To change the distinguishing name and the name that appears on the label from ‘FARMOZ AMETREX 800 WG HERBICIDE’ to ‘AMETREX 800 WG HERBICIDE’
Date of variation: 26 May 2015
Product registration no.: 59635
Label approval no.: 59635/102785
Application no: 102825
Product name: Scotts Lawn Builder Weed, Feed & Green-Up
Active constituent/s: 2.3 g/L dicamba present as the dimethylamine salt, 15 g/L MCPA present as the dimethylamine salt
Applicant name: Scotts Australia Pty Ltd
Applicant ACN: 003 123 162
Summary of variation: To change the distinguishing name and the name that appears on the label from ‘SCOTTS LAWN BUILDER WEED & FEED’ to ‘SCOTTS LAWN BUILDER WEED, FEED & GREEN-UP’
Date of variation: 2 June 2015
Product registration no.: 47860
Label approval no.: 47860/102825
Application no: 102848
Product name: Hopstop Humane Spray Control For Cane Toads
Active constituent/s: 40 g/kg chloroxylenol
Applicant name: Ensystex Australasia Pty Ltd
Applicant ACN: 102 221 965
Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘HOPSTOP SPRAY CONTROL FOR CANE TOADS’ to ‘HOPSTOP HUMANE SPRAY CONTROL FOR CANE TOADS’
Date of variation: 5 June 2015
Product registration no.: 63962
Label approval no.: 63962/102848
Application no: 101736
Product name: Klorman Watertech Chlorine Pellets
Active constituent/s: 680 g/kg available chlorine (CI) present as calcium hypochlorite
Applicant name: Klorman Industries Pty Ltd
Applicant ACN: 072 597 650
Summary of variation: To add an additional label name to the product under ‘KLORMAN WATERTECH DRY CHLORINE 700’
Date of variation: 10 June 2015
Product registration no.: 70009
Label approval no.: 70009/101736
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 12
Agricultural Chemical Products and Approved Labels
Application no: 102910
Product name: Family Protection Aerogard Low Irritant* Odourless 4 Hours Protection Great For Kids 12 Months+ Insect Repellent
Active constituent/s: 95 g/kg picaridin
Applicant name: Reckitt Benckiser (Australia) Pty Limited
Applicant ACN: 003 274 655
Summary of variation: To change the distinguishing name and the name that appears on the label from ‘FAMILY PROTECTION AEROGARD ODOURLESS PROTECTION 4 HOURS PROTECTION LOW IRRITANT* GREAT FOR KIDS 12 MONTHS+ INSECT REPELLENT’ to ‘FAMILY PROTECTION AEROGARD LOW IRRITANT* ODOURLESS 4 HOURS PROTECTION GREAT FOR KIDS 12 MONTHS+ INSECT REPELLENT’
Date of variation: 12 June 2015
Product registration no.: 61364
Label approval no.: 61364/102910
Application no: 102911
Product name: Family Protection Aerogard Low Irritant* Odourless 4 Hours Protection Great For Kids 12 Months + Insect Repellent Spray
Active constituent/s: 92.8 g/L picaridin
Applicant name: Reckitt Benckiser (Australia) Pty Limited
Applicant ACN: 003 274 655
Summary of variation: To change the distinguishing name and the name that appears on the label from ‘FAMILY PROTECTION AEROGARD ODOURLESS PROTECTION 4 HOURS PROTECTION LOW IRRITANT* GREAT FOR KIDS 12 MONTHS + INSECT REPELLENT SPRAY’ to ‘FAMILY PROTECTION AEROGARD LOW IRRITANT* ODOURLESS 4 HOURS PROTECTION GREAT FOR KIDS 12 MONTHS + INSECT REPELLENT SPRAY’
Date of variation: 12 June 2015
Product registration no.: 61365
Label approval no.: 61365/102911
Application no: 63300
Product name: DeLaval Cidisan Acid Milking Machine and Bulk Milk Tank Detergent Sanitiser
Active constituent/s: 213 g/L phosphoric acid, 116 g/L sulfuric acid
Applicant name: Delaval Pty Ltd
Applicant ACN: 004 210 459
Summary of variation: To update the label rates
Date of variation: 15 June 2015
Product registration no.: 63290
Label approval no.: 63290/63300
Application no: 59424
Product name: Melpat Captan 800 WG Fungicide
Active constituent/s: 800 g/kg captan
Applicant name: Melpat International Pty Ltd
Applicant ACN: 066 067 507
Summary of variation: To extend use to include control of certain diseases in almonds
Date of variation: 18 June 2015
Product registration no.: 65788
Label approval no.: 65788/59424
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 13
Agricultural Chemical Products and Approved Labels
Application no: 101561
Product name: Genfarm QPE 200 Herbicide
Active constituent/s: 200 g/L quizalofop-p-ethyl
Applicant name: Landmark Operations Limited
Applicant ACN: 008 743 217
Summary of variation: To add additional 20 L, 100 L, and 110 L pack sizes
Date of variation: 18 June 2015
Product registration no.: 66956
Label approval no.: 66956/101561
Application no: 101430
Product name: Eradicate Snail And Slug Bait
Active constituent/s: 60 g/kg iron EDTA complex
Applicant name: Wattleglen Projects Pty. Limited
Applicant ACN: 006 151 168
Summary of variation: To add a new 50 g pack size
Date of variation: 19 June 2015
Product registration no.: 69600
Label approval no.: 69600/101430
Application no.: 101155
Product name: Loveland Products Liberate Adjuvant
Active constituent/s: 490 g/L soyal phospholipids
Applicant name: Loveland Products, Inc
Applicant ACN: N/A
Summary of variation: To extend the number of herbicides that can be mixed with the product
Date of variation: 19 June 2015
Label approval no.: 67666/101155
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 14
Veterinary Chemical Products and Approved Labels
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 NEW ACTIVE CONSTITUENTS
Application no.: 47685
Product name: Lacticon
Active constituent/s: Min. 108 CFU/mL Megashaera elsdenii NCIMB 41125
Applicant name: BEC Feed Solutions Pty Ltd
Applicant ACN: 010 345 150
Summary of use For use in the establishment of viable Megasphaera elsdenii in the rumen of cattle and sheep to aid in the transition from roughage to grain rations by metabolising lactic acid produced in the gastrointestinal tract
Date of Registration/approval: 18 June 2015
Product registration no.: 64151
Label approval no.: 64151/47685
2. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.: 54438
Product name: Norfenicol 300 mg/mL Solution For Injection For Cattle And Pigs
Active constituent/s: 300 mg/mL florfenicol
Applicant name: Norbrook Laboratories Limited
Applicant ACN: N/A
Summary of use For the treatment of bacterial infections susceptible to florfenicol in cattle and pigs
Date of registration/approval: 11 June 2015
Product registration no.: 66803
Label approval no.: 66803/54438
Application no.: 62868
Product name: Envest (Spinosad) 560 mg Chewable Tablets
Active constituent/s: Each tablet contains 560 mg spinosad
Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd
Applicant ACN: 000 233 992
Summary of use For the prevention, treatment and control of flea infestations and the treatment of flea allergy dermatitis in dogs and cats
Date of registration/approval: 11 June 2015
Product registration no.: 70273
Label approval no.: 70273/62868
Application no.: 62869
Product name: Envest (Spinosad) 140 mg Chewable Tablets
Active constituent/s: Each tablet contains 140 mg spinosad
Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd
Applicant ACN: 000 233 992
Summary of use For the prevention, treatment and control of flea infestations and the treatment of flea allergy dermatitis in dogs and cats
Date of registration/approval: 11 June 2015
Product registration no.: 70274
Label approval no.: 70274/62869
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 15
Veterinary Chemical Products and Approved Labels
Application no.: 62870
Product name: Trifexis (Spinosad + Milbemycin Oxime) Chewable Tablets For Dogs 18.1–27 kg
Active constituent/s: Each tablet contains 810 mg spinosad, 13.5 mg milbemycin oxime
Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd
Applicant ACN: 000 233 992
Summary of use For the prevention of heartworm disease; the treatment and control of hookworm, roundworm and whipworm; the treatment, prevention and control of flea infestation; the control of flea allergy dermatitis in dogs 18.1–27 kg
Date of registration/approval: 11 June 2015
Product registration no.: 70275
Label approval no.: 70275/62870
Application no.: 62871
Product name: Envest (Spinosad) 270 mg Chewable Tablets
Active constituent/s: Each tablet contains 270 mg spinosad
Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd
Applicant ACN: 000 233 992
Summary of use For the prevention, treatment and control of flea infestations and the treatment of flea allergy dermatitis in dogs and cats
Date of registration/approval: 11 June 2015
Product registration no.: 70276
Label approval no.: 70276/62871
Application no.: 62858
Product name: Trifexis (Spinosad + Milbemycin Oxime) Chewable Tablets For Dogs 9.1–18 kg
Active constituent/s: Each tablet contains 560 mg spinosad, 9.3 mg milbemycin oxime
Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd
Applicant ACN: 000 233 992
Summary of use For the prevention of heartworm disease; the treatment and control of hookworm, roundworm and whipworm; the treatment, prevention and control of flea infestation; the control of flea allergy dermatitis in dogs 9.1–18 kg
Date of registration/approval: 11 June 2015
Product registration no.: 70267
Label approval no.: 70267/62858
Application no.: 62860
Product name: Trifexis (Spinosad + Milbemycin Oxime) Chewable Tablets For Dogs 4.6–9 kg
Active constituent/s: Each tablet contains 270 mg spinosad, 4.5 mg milbemycin oxime
Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd
Applicant ACN: 000 233 992
Summary of use For the prevention of heartworm disease; the treatment and control of hookworm, roundworm and whipworm; the treatment, prevention and control of flea infestation; the control of flea allergy dermatitis in dogs 4.6–9 kg
Date of registration/approval: 12 June 2015
Product registration no.: 70268
Label approval no.: 70268/62860
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 16
Veterinary Chemical Products and Approved Labels
Application no.: 62861
Product name: Trifexis (Spinosad + Milbemycin Oxime) Chewable Tablets For Dogs 2.3–4.5 kg
Active constituent/s: Each tablet contains 140 mg spinosad, 2.3 mg milbemycin oxime
Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd
Applicant ACN: 000 233 992
Summary of use For the prevention of heartworm disease; the treatment and control of hookworm, roundworm and whipworm; the treatment, prevention and control of flea infestation; the control of flea allergy dermatitis in dogs 2.3–4.5 kg
Date of registration/approval: 12 June 2015
Product registration no.: 70269
Label approval no.: 70269/62861
Application no.: 62862
Product name: Envest (Spinosad) Chewable Tablets For Dogs 18.1–27 kg
Active constituent/s: Each tablet contains 810 mg spinosad
Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd
Applicant ACN: 000 233 992
Summary of use For the prevention, treatment and control of flea infestations and the treatment of flea allergy dermatitis in dogs
Date of registration/approval: 12 June 2015
Product registration no.: 70270
Label approval no.: 70270/62862
Application no.: 62865
Product name: Envest (Spinosad) Chewable Tablets For Dogs 27.1–54 kg
Active constituent/s: Each tablet contains 1620 mg spinosad
Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd
Applicant ACN: 000 233 992
Summary of use For the prevention, treatment and control of flea infestations and for the treatment of flea allergy dermatitis in dogs
Date of registration/approval: 12 June 2015
Product registration no.: 70271
Label approval no.: 70271/62865
Application no.: 62866
Product name: Trifexis (Spinosad + Milbemycin Oxime) Chewable Tablets For Dogs 27.1–54 kg
Active constituent/s: Each tablet contains 1620 mg spinosad, 27 mg milbemycin oxime
Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd
Applicant ACN: 000 233 992
Summary of use For the prevention of heartworm disease; the treatment and control of hookworm, roundworm and whipworm; the treatment, prevention and control of flea infestation; the control of flea allergy dermatitis in dogs 27.1–54 kg
Date of registration/approval: 12 June 2015
Product registration no.: 70272
Label approval no.: 70272/62866
Application no.: 59939
Product name: M-Eloxyn 20 mg/mL Injection For Horses
Active constituent/s: 20 mg/mL meloxicam
Applicant name: Zoetis Australia Pty Ltd
Applicant ACN: 156 476 425
Summary of use For use as a non-steroidal anti-inflammatory, analgesic and antipyretic in horses
Date of registration/approval: 15 June 2015
Product registration no.: 69089
Label approval no.: 69089/59939
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 17
Veterinary Chemical Products and Approved Labels
Application no.: 62514
Product name: Selenium Oral Concentrate
Active constituent/s: 10 mg selenium (Se) per mL as sodium selenite
Applicant name: Landmark Operations Limited
Applicant ACN: 008 743 217
Summary of use For the prevention and treatment of conditions caused by selenium deficiency in cattle, sheep and poultry
Date of registration/approval: 15 June 2015
Product registration no.: 70103
Label approval no.: 70103/62514
Application no.: 63199
Product name: Neove Meloxicam 20 Injection
Active constituent/s: 20 mg/mL meloxicam
Applicant name: Neove Pharma Australia Pty Limited
Applicant ACN: 140 367 442
Summary of use For single dose rapid initiation of therapy of musculoskeletal disorders and relief of pain associated with colic
Date of registration/approval: 15 June 2015
Product registration no.: 70333
Label approval no.: 70333/63199
Application no.: 101618
Product name: IO Independents Own Acid Neutralizer Mild Diuretic and Urinary Buffer For Horses and Greyhounds
Active constituent/s: 285 g/L sodium acid citrate
Applicant name: C M Laboratories Pty Ltd
Applicant ACN: 098 897 637
Summary of use For use in the prevention and treatment of acidosis and muscle cramping in greyhounds
and horses
Date of registration/approval: 16 June 2015
Product registration no.: 80780
Label approval no.: 80780/101618
Application no.: 56197
Product name: Urilin Syrup For Dogs
Active constituent/s: 50 mg/mL phenylpropanolamine hydrochloride
Applicant name: Dermcare-Vet Pty. Ltd
Applicant ACN: 010 280 010
Summary of use For use in dogs (bitches) to control urinary incontinence associated with acquired urinary sphincter incompetence
Date of registration/approval: 22 June 2015
Product registration no.: 67499
Label approval no.: 67499/56197
Application no.: 59107
Product name: Pharmachem Swat Insecticide for Horses
Active constituent/s: 87 g/L permethrin (25:75 cis:trans)
Applicant name: Bocko P/L & Flexsky P/L (In Partnership) T/A Pharmachem
Applicant ACN: 078 722 371 & 105 967 575
Summary of use For the control of biting and nuisance flies on horses and as an aid in the treatment of Queensland itch
Date of registration/approval: 22 June 2015
Product registration no.: 68798
Label approval no.: 68798/59107
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 18
Veterinary Chemical Products and Approved Labels
Application no.: 51102
Product name: Bob Martin since 1892 Flea Rid for Dogs, Cats, Puppies and Kittens Shampoo
Active constituent/s: 1 g/L pyrethrins, 10 g/L piperonyl butoxide
Applicant name: Bob Martin (Australia) Pty Ltd
Applicant ACN: 062 627 883
Summary of use For the control of fleas and to aid in the control of adult brown dog tick on dogs and cats
Date of registration/approval: 22 June 2015
Product registration no.: 65521
Label approval no.: 65521/51102
Application no.: 62813
Product name: Apex Clindamycin 150 Tablets
Active constituent/s: Each tablet contains 150 mg clindamycin (as clindamycin hydrochloride)
Applicant name: Apex Laboratories Pty Ltd
Applicant ACN: 000 397 240
Summary of use For the oral treatment of dental infections, wounds, abscesses and osteomyelitis caused by bacteria susceptible to clindamycin in dogs and cats
Date of registration/approval: 22 June 2015
Product registration no.: 70247
Label approval no.: 70247/62813
3. VARIATIONS OF REGISTRATION
Application no.: 102789
Product name: Cooling Gel Topical Cooling And Soothing Gel For Horses
Active constituent/s: 350 mg/g isopropyl alcohol, 2 mg/g eucalyptus oil, 6.26 mg/g camphor, 20 mg/g menthol
Applicant name: Floris Veterinaire Produkten B.V
Applicant ACN: N/A
Summary of variation: To change the distinguishing name from ‘TROY COOLING GEL TOPICAL COOLING AND SOOTHING GEL FOR HORSES’ to ‘COOLING GEL TOPICAL COOLING AND SOOTHING GEL FOR HORSES’
Date of variation: 27 May 2015
Product registration no.: 38753
Label approval no.: 38753/102789
Application no.: 62832
Product name: Pharmachlor CTC Chlortetracycline Soluble Powder
Active constituent/s: 950 g/kg chlortetracycline hydrochloride
Applicant name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of variation: To vary the registered particulars and label particulars
Date of variation: 10 June 2015
Product registration no.: 54719
Label approval no.: 54719/62832
Application no.: 58703
Product name: Y-Tex Agressor Cattle Ear Tags
Active constituent/s: 80 g/kg abamectin, 180 g/kg piperonyl butoxide
Applicant name: Landmark Operations Limited
Applicant ACN: 008 743 217
Summary of variation: To extend use to dairy cattle (including lactating dairy cattle)
Date of variation: 10 June 2015
Product registration no.: 62199
Label approval no.: 62199/58703
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 19
Veterinary Chemical Products and Approved Labels
Application no.: 101024
Product name: Vetmedin 5 mg Chewable Tablets For Dogs
Active constituent/s: each tablet contains 5 mg pimobendan
Applicant name: Boehringer Ingelheim Pty Limited, Vetmedica Division
Applicant ACN: 000 452 308
Summary of variation: To update the claims to include use in large breed dogs with preclinical DCM
Date of variation: 23 June 2015
Product registration no.: 60798
Label approval no.: 60798/101024
Application no.: 101027
Product name: Vetmedin 2.5 MG Chewable Tablets For Dogs
Active constituent/s: each tablet contains 2.5 mg pimobendan
Applicant name: Boehringer Ingelheim Pty Limited, Vetmedica Division
Applicant ACN: 000 452 308
Summary of variation: To update the claims to include use in large breed dogs with preclinical DCM
Date of variation: 23 June 2015
Product registration no.: 60799
Label approval no.: 60799/101027
4. LABEL APPROVAL
Application no.: 101769
Product name: Aristopet Stop-Itch
Active constituent/s: 15 g/L povidone-iodine, 6 g/L iodophor, (equivalent to 0.75% available iodine)
Applicant name: Aristopet Pty Ltd
Applicant ACN: 145 418 882
Summary of use: To add an additional label name to the product under ‘GREASY HEEL AND FUNGAL
SKIN LOTION’
Date of approval: 12 June 2015
Label approval no.: 56564/101769
5. VARIATION OF LABEL APPROVAL
Application no.: 61548
Product name: Ultravac Scourshield Vaccine
Active constituent/s: Bovine rotavirus G6≥1.3 RP/2 mL, Bovine rotavirus G10≥1 RP/2 mL, Bovine coronavirus ≥1 RP/2 mL, E. coli K99≥1 RP/2 mL
Applicant name: Zoetis Australia Pty Ltd
Applicant ACN: 156 476 425
Summary of variation: To add subcutaneous route of administration
Date of variation: 18 June 2015
Label approval no.: 65032/61548
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 20
Approved Active Constituents
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.: 100598
Active constituent/s: Trifloxystrobin
Applicant name: Yongnong Biosciences Co., Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 11 June 2015
Approval no.: 80311
Application no.: 100671
Active constituent/s: Terbuthylazine
Applicant name: Shandong Binnong Technology Co., Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 11 June 2015
Approval no.: 80351
Application no.: 100580
Active constituent/s: Pymetrozine
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of use: For use in agricultural chemical products
Date of approval: 11 June 2015
Approval no.: 80303
Application no.: 63115
Active constituent/s: Ethofumesate
Applicant name: Adama Australia Pty Limited
Applicant ACN: 050 328 973
Summary of use: For use in agricultural chemical products
Date of approval: 19 June 2015
Approval no.: 70315
Application no.: 100487
Active constituent/s: S-Metolachlor
Applicant name: Shandong Binnong Technology Co., Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 30 June 2015
Approval no.: 80258
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 21
Fluensulfone in the product Nimitz 480 EC Nematicide
Fluensulfone in the product Nimitz 480 EC Nematicide
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from ADAMA
AUSTRALIA PTY LTD, for registration of a new product containing the active constituent fluensulfone. The product
NIMITZ 480 EC NEMATICIDE is for use prior to planting the following crops: Cucurbits, Tomatoes (not for processing),
Capsicum, Chilli, Eggplant and Okra.
PARTICULARS OF THE APPLICATION
Proposed product name(s): NIMITZ 480 EC NEMATICIDE
Applicant company: ADAMA AUSTRALIA PTY LTD
Name of active constituent: Fluensulfone
Signal heading: Schedule 6
Summary of proposed use: For control of Root-knot nematode in the following transplanted crops:
Cucurbits, Tomatoes (not for processing), Capsicum, Chilli, Eggplant and
Okra.
Pack sizes: 500 ml–1000 L
Withholding period:
States:
Harvest: Not required when used as directed.
Grazing: Do not graze treated crop, or feed treated crop
commodities to livestock.
Queensland only
SUMMARY OF THE APVMA’S EVALUATION OF NIMITZ 480 EC NEMATICIDE IN ACCORDANCE WITH SECTIONS
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 NIMITZ 480 EC NEMATICIDE containing the active constituent
fluensulfone 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 that it can be used safely.
The product will be used for commercial use situations, and farmers and their employees will be the main users of
the product. Workers may be exposed to the product when opening containers, mixing/loading, application (or
connecting containers during chemigation and cleaning up spills and equipment). The main route of exposure to
the product/spray will be dermal and inhalation, with limited occupational exposure possible during mixing/loading
and application.
In the absence of exposure data for the proposed mode of application, the Pesticide Handler Exposure Database
(PHED) Surrogate Exposure Guide was used to estimate exposure. Exposure to the product by the stated
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 22
Fluensulfone in the product Nimitz 480 EC Nematicide
application methods was at an acceptable level when a single layer of clothing (cotton overalls or equivalent
clothing) and elbow-length chemical resistant gloves are worn.
Based on the risk assessment, a First Aid Instruction, Safety Directions and a Warning statement have been
recommended for the product label.
(ii) The APVMA is satisfied that the proposed use of NIMITZ 480 EC NEMATICIDE will not be an undue hazard to the
safety of people using anything containing its residues provided the product is used in accordance with the
proposed label directions.
Long term (chronic) dietary exposure as estimated by the national estimated dietary intake calculation is
acceptable. The short term (acute) dietary exposure as estimated by the national estimated short term intake
calculation is also acceptable.
Maximum Residue Limits (MRLs) for cucurbits, fruiting vegetables (other than cucurbits) and animal commodities
have been recommended.
(iii) The APVMA is satisfied that the proposed use of NIMITZ 480 EC NEMATICIDE containing the active constituent
fluensulfone is not likely to be harmful to human beings if used according to the product label directions.
A comprehensive toxicology and public health dataset was submitted for registration of the active constituent
fluensulfone and associated product in the United States of America, Canada and Australia as part of a Global
Joint Review. The toxicology assessment of fluensulfone was conducted jointly by scientists from the United States
(US EPA), Canada (PMRA), and Australia (OCS).
Fluensulfone is a new chemical class of nematicide. The product, NIMITZ 480EC Nematicide an emulsifiable
concentrate formulation containing 480 g/L fluensulfone, is a commercial use nematicide and is to be applied to
bare soil pre-planting of seedlings and immature plants, including cucurbits and fruiting vegetables. The product will
be available in high density polyethylene (HDPE) containers of 500 mL to 1000 L and will be applied at a label rate
of 4–8 L/ha as a coarse spray using conventional broadcast spray application equipment or by ground application
through band application or drip irrigation methods. The maximum proposed application rate is a single application
of 3.84 kg a.i. per hectare.
Fluensulfone was of low acute oral, acute dermal and acute inhalational toxicity in rats. It was a slight skin irritant in
rabbits but was not an eye irritant in the same species. It was a skin sensitiser in guinea pigs.
The systemic toxicity of fluensulfone in dietary studies consisted primarily of decreased body weight and body
weight gain, and changes in haematology parameters. This systemic toxicity profile was observed in short-term,
subchronic and chronic toxicity studies in rats, mice and dogs, with the available data indicating that rats and dogs
were more sensitive than mice. No treatment related effects were observed upon short term dermal administration
of fluensulfone up to 400 mg/kg bw/day in rats. In a 90–day inhalational study in rats (nose only), effects were seen
at the lowest concentration tested of 40 mg/m3 (decreased weight gain, increased prothrombin time, decreased
thymus weight and histopathology in the epiglottis).
In a dietary carcinogenicity study in mice, an increase was seen in the incidence of alveolar/bronchiolar adenomas
and alveolar/bronchiolar adenomas and carcinomas combined in female mice. The relevance of this finding to
humans was considered in Mode of Action studies; however, the available data were insufficient. No increased
incidence of tumours was seen in male mice, or male and female rats in a 2–year dietary study.
Fluensulfone was a neurotoxicant producing neurobehavioural changes following administration of a bolus (i.e.
gavage) dose, but such findings were not seen for dietary administration. Fluensulfone was not an in vivo
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 23
Fluensulfone in the product Nimitz 480 EC Nematicide
genotoxicant, a reproductive or teratogenic toxicant, or an immunotoxicant, and studies on metabolites provided no
data that indicates that the observed level of these metabolites and their limited toxicity profile presents a
toxicological concern.
The product NIMITZ 480EC Nematicide has low acute oral, dermal and inhalational toxicity in rats, is a moderate
skin and eye irritant in rabbits, and is a skin sensitiser in guinea pigs. Additionally, NIMITZ 480EC Nematicide is
considered to be an aspiration hazard based on the formulated products toxicological profile.
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 NIMITZ 480 EC NEMATICIDE when used in accordance with the label directions.
(iv) The APVMA is satisfied that the proposed use of fluensulfone in the product NIMITZ 480 EC NEMATICIDE for the
control of soil nematodes would not be likely to have an unintended effect that is harmful to animals, plants or
things or to the environment if used according to the product label directions.
The Department of the Environment has assessed data in support of the proposed use and has concluded that the
risks to the environment from this use are acceptable.
Fluensulfone is stable to hydrolysis but it readily degrades by aquatic photolysis, and can be expected to be fairly
degradable in water systems. Aerobic soil microbial degradation is expected to be a significant route for
environmental degradation of the nematicide which is not identified as persistent. Fluensulfone does not very
strongly adsorb to soil and is expected to be of high to medium mobility. It is not expected to bioconcentrate in
aquatic species.
Fluensulfone is practically nontoxic to birds with acute exposure and did not exhibit toxicity in reproduction studies.
Acute toxicity tests showed that the chemical and its metabolites are slightly toxic to fish and aquatic invertebrates,
chronic studies indicated also only slight toxicity. Fluensulfone and the proposed formulation are very highly toxic to
green algae; while several of its metabolites are at worst slightly toxic to these organisms. Acute oral or contact
exposure studies showed it is only very slightly toxic to honeybees. Fluensulfone is slightly toxic to earthworms and
is not expected to have adverse effects on earthworm or soil arthropod survival and reproduction. It is not expected
to have significant effects on soil nitrogen transformation and carbon turnover. Fluensulfone is not expected to
have significant phytotoxic effects on non-target plants.
The Department has considered the potential risk to organisms in the terrestrial and aquatic environment from the
proposed uses of the product, based on ground application by low boom sprayers and by drip irrigation as
proposed by the draft label. The risk assessment determined that under the proposed use pattern the uses are
unlikely to pose an environmental risk to birds and mammals. The risk to aquatic organisms from leaching, spray
drift or runoff is acceptable provided a downwind no-spray zone is established and the label bears appropriate
warning statements regarding to avoid runoff.
The APVMA has considered the findings of the Department of the Environment and accepts these conclusions.
(v) The APVMA is considering whether the proposed use of NIMITZ 480 EC NEMATICIDE containing the active
constituent fluensulfone would not adversely affect trade between Australia and places outside Australia.
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 24
Fluensulfone in the product Nimitz 480 EC Nematicide
Fruiting vegetables, including cucurbits are not considered major export commodities1 and the overall risk to export
trade is considered to be low.
There is potential for residues of fluensulfone to occur in rotational crops, however the initial registration will be
restricted to Queensland only, which together with the proposed plant back intervals appropriately mitigate the risk
of residues of fluensulfone metabolites occurring in rotational crops that are major export commodities or can be
used as animal feeds. For sugarcane, a 2–year plant back interval and also the processing of sugar reduces the
risk to trade.
(vi) 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, www.apvma.gov.au/news-and-publications/public-consultations or through the contact 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 NIMITZ 480 EC NEMATICIDE 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:
contact name
company or group name (if relevant)
email or postal address
the date you made the submission.
1 Part 5B of the Vet Requirements Series and Ag Requirements Series, Overseas Trade Aspects of Residues in Food Commodities, August 2004.
Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 25
Fluensulfone in the product Nimitz 480 EC Nematicide
All personal and confidential commercial information (CCI)2 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
2 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
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