APVMA Gazette No. 22, 4 November 2014 · 11/4/2014 · Commonwealth of Australia Gazette No. APVMA 22, Tuesday, 4 November 2014 Agricultural and Veterinary Chemicals Code Act 1994

No. APVMA 22, Tuesday, 4 November 2014

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 22, Tuesday, 4 November 2014 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2014

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: [email protected]

Website: www.apvma.gov.au.

GENERAL INFORMATION

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

the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices a s 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.

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CONTENTS

Erratum Notice ....................................................................................................................................................................... 3 Agricultural Chemical Products and Approved Labels............................................................................................................ 4 Veterinary Chemical Products and Approved Labels ........................................................................................................... 19 Approved Active Constituents .............................................................................................................................................. 22 Cancellation of Label Approval at the Request of the Holder ............................................................................................... 23 Cancellation of Label Approval at the Request of the Holder ............................................................................................... 24 Cancellation of Label Approval at the Request of the Holder ............................................................................................... 25 Cancellation of Approval at the Request of the Holder ......................................................................................................... 26 Cancellation of the Registrations of Products and All Associated Labels Containing Fenthion due to the Voluntary Cancellation of the Active Constituent .................................................................................................................................. 27 Exemption from Offence Provisions ..................................................................................................................................... 29 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code ................................................... 31

Erratum Notice

The Australian Pesticides and Veterinary Medicines Authority advises that two errors were published in the Commonwealth of Australia Gazette for Agricultural and Veterinary Chemicals, No. APVMA 21, 21 October, 2014.

In the notice, product numbers 69203 and 67056 did not contain the label approval number of the cancelled labels. The correct notices appear on page 23 and 24 of this Gazette.


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.: 62707

Product name: Zodiac Stabilised Pool Chlorine

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

Applicant name: Zodiac Group Australia Pty Ltd

Applicant ACN: 002 641 965

Summary of use: For controlling bacteria, viruses & algae in swimming pools

Date of registration/approval: 10 September 2014

Product registration no.: 70194

Label approval no.: 70194/62707


Product name: Zodiac Pool Sparkle Sanitiser Chlorine

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



Summary of use: For controlling bacteria and algae in swimming pools

Date of registration/approval: 22 September 2014




Product name: Pool Clear Granular Chlorine

Active constituent/s: 650 g/kg available chlorine (CI) present as calcium hypochlorite

Applicant name: Pool Resources Pty Limited


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

Date of registration/approval: 1 October 2014



Application No: 62939

Product Name: AquaHealth Ezi-Chlor For Pools

Active Constituent/s: 110 g/kg sodium tetraborate pentahydrate, 810 g/kg available chlorine present as trichloroisocyanuric acid

Applicant Name: Waterco Limited


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



Label Approval No: 70289/62939




Product name: Fyfanon Premium Insecticide

Active constituent/s: 320 g/L maldison (an anticholinesterase compound)

Applicant name: Cheminova Australia Pty Limited


Summary of use: For the control of various insect and mite pests in apples





Product name: Cruze 300 Herbicide

Active constituent/s: 300 g/L paraquat present as paraquat dichloride

Applicant name: Spalding Holdings Pty. Ltd


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





Product name: Nufarm NU 700 Surfactant

Active constituent/s: 350 g/L soyal phospholipids, 350 g/L propionic acid

Applicant name: Nufarm Australia Limited


Summary of use For acidifying purposes, as a penetrating surfactant, reducing alkaline hydrolysis of dimethoate and managing of spray droplet size





Product name: Genfarm Flutriafol Max In Furrow And Foliar Fungicide

Active constituent/s: 500 g/L flutriafol

Applicant name: Landmark Operations Limited


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





Product name: Sinochem Scalpel Selective Herbicide

Active constituent/s: 240 g/L clethodim

Applicant name: Sinochem Agro Co., Ltd

Applicant ACN: N/A

Summary of use: For the control of certain grass weeds in a range of broad acre horticultural, pasture, seed crop and forestry situations







Product name: ZODIAC spa bromine sanitiser tablets

Active constituent/s: 650 g/kg available bromine, 280 g/kg available chlorine (Cl) present as bromochlorodimethylhydanton



Summary of use For killing and controlling algae and bacteria in spas





Product name: K-Obiol EC Combi Synergised Grain Protectant

Active constituent/s: 400 g/L piperonyl butoxide, 50 g/L deltamethrin

Applicant name: Bayer Cropscience Pty Ltd


Summary of use For use in stored cereal grain for the control of various pest insects





Product name: Eraze Pro K 450 Herbicide

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

Applicant name: Amgrow Pty Ltd


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





Product name: Yates Nature's Way Vegie & Herb Spray

Active constituent/s: 8.5 g/L potassium salts of fatty acids

Applicant name: Duluxgroup (Australia) Pty Ltd


Summary of use: For the control of a variety of insect pests on a range of edible and ornamental plants





Product name: Yates Nature's Way Vegie & Herb Spray Concentrate

Active constituent/s: 285 g/L potassium salts of fatty acids

Applicant name: Duluxgroup (Australia) Pty Ltd


Summary of use: For the control of a variety of insect pests on a range of edible and ornamental plants







Product name: Warlock Insecticide

Active constituent/s: 17 g/L emamectin present as emamectin benzoate

Applicant name: Adama Australia Pty Limited


Summary of use: For the control of heliothis in cotton, capsicum, lettuce, sweet corn and tomatoes; diamondback moth and cabbage white butterfly in brassica vegetables, light brown apple moth and grapevine moth in grapes, and suppression of mites and green mirids in cotton





Product name: Dupont Benevia Insecticide

Active constituent/s: 100 g/L cyantraniliprole

Applicant name: Du Pont (Australia) Pty Ltd


Summary of use: For control of sucking and chewing insects in certain vegetable crops





Product name: Bushman Roll-On Personal Insect Repellent

Active constituent/s: 200 g/kg diethyltoluamide

Applicant name: Juno Limited

Applicant ACN: N/A

Summary of use: For use as a roll-on personal insect repellent





Product name: FMC Astroid 400 EC Herbicide

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

Applicant name: FMC Australasia Pty Ltd


Summary of use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, millets, pastures, sorghum, sugar cane, sweet corn and winter cereals





Product name: Crop Culture Armoury Herbicide

Active constituent/s: 150 g/L imazapyr present as the potassium salt, 150 g/L glyphosate present as the potassium salt.

Applicant name: Crop Culture Pty Ltd


Summary of use: For the control of various annual and perennial weeds in non-crop situations







Product name: AC Trample 400 Herbicide

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

Applicant name: Axichem Pty Ltd


Summary of use: To control a wide range of broadleaf weeds in a range of crops, broadleaf and woody weeds in agricultural non-crop areas, commercial and industrial areas, forests, pastures and rights of way





Product name: Aerogard Extreme Activities 40% Deet Aerogard's Highest Strength Repellent Personal Insect Repellent

Active constituent/s: 400 g/kg diethyltoluamide

Applicant name: Reckitt Benckiser (Australia) Pty Limited


Summary of use: For use as a personal insect repellent





Product name: Gardenline 100 Weed Kill Concentrate

Active constituent/s: 100 g/L glyphosate (present as the isopropylamine salt)

Applicant name: Amgrow Pty Ltd


Summary of use: For the control of weeds and grasses in the home garden





Product name: Surefire Propyzamide 500 SC Herbicide

Active constituent/s: 500 g/L propyzamide

Applicant name: PCT Holdings Pty Ltd


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





Product name: Macro Protect Glyphosate 450 Herbicide

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

Applicant name: Louis Dreyfus Commodities Australia Pty. Ltd


Summary of use: For non-selective weed control in a variety of situations







Product name: Protect Skin Technology Insect Repellent Deet Free Roll On

Active constituent/s: 191 g/kg picaridin

Applicant name: Skin Technology Limited

Applicant ACN: N/A

Summary of use: For use as a personal insect repellent





Product name: Atlas Ant Killer

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

Applicant name: STV International Ltd

Applicant ACN: N/A

Summary of use: For controlling ants, fleas and bedbugs, for indoor and outdoor use





Product Name: Aako Vitnam 225 SL Insecticide

Active Constituent/s: 225 g/L methomyl

Applicant Name: Aako Australia Pty Limited


Summary of Use For the control of certain pests of crops including cereals, fruit, legumes, cotton, oil seed crops, tobacco, hops, vegetables, pastures, peanuts, ginger and duboisia

Date of Registration/Approval: 24 October 2014

Product Registration No: 69721

Label Approval No.: 69721/61502


Product Name: Searles Weed & Gro Pro

Active Constituent/s: 15 g/L MCPA present as dimethylamine salt, 2.3 g/L dicamba

present as dimethylamine salt

Applicant Name: J C & A T Searle Pty Ltd


Summary of Use For control of broadleaf weeds in lawns





Product Name: Atlas 2 In 1 Indoor Outdoor Barrier Spray

Active Constituent/s: 0.50 g/L bifenthrin

Applicant Name: Brunnings Garden Products Pty Ltd


Summary of Use For the control of household pests






2. VARIATIONS OF REGISTRATION


Product Name: Mortein Naturgard Crawling Insect Surface Spray Contains Natural Eucalyptus Extracts Over 90% Natural Ingredients

Active Constituent/s: 0.6 g/kg deltamethrin, 0.4 g/kg imiprothrin

Applicant Name: Reckitt Benckiser (Australia) Pty Limited


Summary of Variation: To change the product name from ‘MORTEIN NATURGARD SURFACE SPRAY CRAWLING INSECT KILLER EUCALYPTUS’ to ‘MORTEIN NATURGARD CRAWLING INSECT SURFACE SPRAY CONTAINS NATURAL EUCALYPTUS EXTRACTS OVER 90% NATURAL INGREDIENTS’ and to add pack sizes

Date of Variation: 11 September 2014




Product Name: Fast Action Ratsak Throwpacks Kills Rats & Mice

Active Constituent/s: 0.05 g/kg brodifacoum

Applicant Name: Duluxgroup (Australia) Pty Ltd


Summary of Variation: To include additional pack sizes

Date of Variation: 23 September 2014




Product Name: Pintobi Attack Herbicide With IQ Inside

Active Constituent/s: 570 g/L glyphosate (present as the potassium salt)

Applicant Name: Nufarm Australia Limited


Summary of Variation: To extend the label claims to include pre-harvest uses in canola and increase the pre-harvest use rate in wheat

Date of Variation: 1 October 2014




Product Name: Nufarm Weedmaster DST Dual Salt Technology Herbicide

Active Constituent/s: 470 g/L glyphosate (present as the potassium and mono-ammonium salts)



Summary of Variation: To extend use to include higher pre-harvest wheat rate and a pre-harvest canola use pattern







Product Name: Mortein ProGard Protection Cockroach Baits

Active Constituent/s: 2.5 g/kg indoxacarb

Applicant Name: Reckitt Benckiser (Australia) Pty Limited


Summary of Variation: To change the product name from: ‘MORTEIN NEST KILL 3 MONTH PROTECTION COCKROACH BAITS’ to: ‘MORTEIN PROGARD PROTECTION COCKROACH BAITS’





Product Name: Custodia Fungicide

Active Constituent/s: 200 g/L tebuconazole, 120 g/L azoxystrobin

Applicant Name: Adama Australia Pty Limited


Summary of Variation: To extend the label claims to include control of early and late spot, rust and net blotch in peanuts





Product Name: Permatek IM 30 Insecticide

Active Constituent/s: 30 g/L imidacloprid

Applicant Name: Zelam Pty Ltd


Summary of Variation: To extend the label claim against softwood borers





Product Name: Spraytop 250 SL Herbicide

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



Summary of Variation: To change the product name from ‘FARMOZ SPRAYTOP 250 SL HERBICIDE’ to ‘SPRAYTOP 250 SL HERBICIDE’ and to alter diuron references related to rates and uses to be consistent with diuron review





Product Name: Choice Low Odour Amine 625 Herbicide

Active Constituent/s: 625 g/L 2,4–D present as the dimethylamine and diethanolamine salts

Applicant Name: Grow Choice Pty Limited


Summary of Variation: To add Diuron tank mix statements and requirements as per Diuron review and remove use for wild radish in wheat and barley if mixed with Tribunex







Product Name: Zulu Evo 720 Herbicide

Active Constituent/s: 720 g/L 2,4–D present as the dimethylamine salt



Summary of Variation: To add the claims control of emerged broadleaf weeds prior to sowing crops and pastures in conservation tillage situation





Product Name: Barrack Betterstick Fungicide

Active Constituent/s: 720 g/L chlorothalonil

Applicant Name: Crop Care Australasia Pty Ltd


Summary of Variation: To extend the use on chickpeas and lentils to include Tasmania





Product Name: Reglone Non-Residual Herbicide

Active Constituent/s: 200 g/L diquat present as diquat dibromide monohydrate

Applicant Name: Syngenta Australia Pty Ltd


Summary of Variation: To reduce harvest withholding period in poppies and to add an additional pack size



Label Approval No: 62108


Product Name: Rid Australia Medicated Rid Insect Repellent Low Irritant + Antiseptic Pump Spray 3 Hours Mosquito Protection Neutral Scent For Children And Sensitive Skin

Active Constituent/s: 100 g/L n,n-diethyl-m-toluamide (DEET), 20 g/L n-octyl bicycloheptene dicarboximide, 10 g/L di-n-propyl isocinchomeronate, 1 g/L triclosan

Applicant Name: Cavalieri Investing Pty Ltd


Summary of Variation: To change the product name from ‘MEDICATED RID REPELLENT LOW IRRITANT’ to ‘RID AUSTRALIA MEDICATED RID INSECT REPELLENT LOW IRRITANT + ANTISEPTIC PUMP SPRAY 3 HOURS MOSQUITO PROTECTION NEUTRAL SCENT FOR CHILDREN AND SENSITIVE SKIN’, add an additional pack size and to add use in biting midge







Product Name: Rid Australia Medicated Rid Insect Repellent Antiseptic + Chamomile + Vitamin E 4 Hours Mosquito Protection Neutral Scent Total Family Protection




Summary of Variation: To change the product name from ‘MEDICATED RID REPELLENT PLUS ANTISEPTIC’ to ‘RID AUSTRALIA MEDICATED RID INSECT REPELLENT ANTISEPTIC + CHAMOMILE + VITAMIN E 4 HOURS MOSQUITO PROTECTION NEUTRAL SCENT TOTAL FAMILY PROTECTION’ and to add additional pack sizes





Product Name: Rid Australia Medicated Rid Repellent Kids + Antiseptic Roll-On 2 Hours Mosquito Protection Neutral Scent For Sensitive Skin & Children Over 12 Months




Summary of Variation: To change the product name from ‘KIDS RID REPELLENT’ to ‘RID AUSTRALIA MEDICATED RID INSECT REPELLENT KIDS + ANTISEPTIC ROLL-ON 2 HOURS MOSQUITO PROTECTION NEUTRAL SCENT FOR SENSITIVE SKIN & CHILDREN OVER 12 MONTHS’, add an additional pack size and add use in biting midge





Product Name: Eco - Neem Botanical Insecticide

Active Constituent/s: 11.82 g/L azadirachtin A and B present as 29.55 g/L Azadirachta indica extract

Applicant Name: Organic Crop Protectants Pty Ltd


Summary of Variation: To extend use to include the control of wingless grasshoppers





Product Name: Sempra Herbicide

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



Summary of Variation: To add uses with two adjuvants to the relevant label particulars







Product Name: Tri-Power Seed Treatment

Active Constituent/s: 180 g/L imidacloprid, 30 g/L metalaxyl, 6.25 g/L flutriafol

Applicant Name: Crop Care Australasia Pty Ltd


Summary of Variation: To add new insect pests of the stored seed grain to existing use patterns





Product Name: Celphide Fumigation Tablets

Active Constituent/s:

330 g/kg phosphine (PH3) present as aluminium phosphide each 3 g tablet liberates 1 g phosphine (PH3)

Applicant Name: Excel Crop Care (Australia) Pty Ltd


Summary of Variation: To have additional use situation to control rabbits in burrows





Product Name: Promote Plus 900 Growth Regulator

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



Summary of Variation: To change the product name from ‘PROMOTE 900 GROWTH REGULATOR’ to ‘PROMOTE PLUS 900 GROWTH REGULATOR’ and add additional formulators





Product Name: Yates Tomato And Vegetable Dust Dual Action Insecticide And Fungicide

Active Constituent/s: 400 g/kg sulfur(s) present as elemental sulfur, 40 g/kg copper (Cu) present as copper oxychloride, 0.25 g/kg spinetoram

Applicant Name: Duluxgroup (Australia) Pty Ltd


Summary of Variation: To extend the use to include the additional target pests of aphids and melon thrips





Product Name: Turf Mark Blue Spray Marker For Turf Use

Active Constituent/s: 299 g/L blue colourant

Applicant Name: BASF Agricultural Specialties Pty Ltd


Summary of Variation: To change the product name from ‘BECKER UNDERWOOD TURF MARK BLUE SPRAY MARKER FOR TURF USE’ to ‘TURF MARK BLUE SPRAY MARKER FOR TURF USE’







Product name: Nufarm Weedmaster DST Dual Salt Technology Herbicide

Active constituent/s: 470 g/L glyphosate (present as the potassium and mono-ammonium salts)

Applicant name: Nufarm Australia Limited


Summary of variation: To extend the use to include control of weeds in Roundup Ready Flex (glyphosate tolerant) cotton as an over-the-top application

Date of variation: 17 October 2014


Label approval no: 62723/59604


Product Name: Lontrel Advanced Herbicide

Active Constituent/s: 600 g/L clopyralid present as the dimethylamine salt

Applicant Name: Dow Agrosciences Australia Limited


Summary of Variation: To add new use pattern to control flaxleaf fleabane in pasture, forests, rights-of-way and industrial situations, add new use pattern in canola pre-emergence, amend crop growth stages and timing of application and amend plantback periods in cereals and canola





Product Name: Jinhong Termite Protection Barrier

Active Constituent/s: 2 g/kg deltamethrin (equivalent to 1 g/m2 deltamethrin)

Applicant Name: Jinhong Australia Pty Ltd


Summary of Variation: To add an additional pack size





Product Name: Rainbow Picloram 75–D Herbicide


300 g/L 2,4–D, present as the triisopropanolamine salt, 75 g/L picloram, present as the triisopropanolamine salt

Applicant Name: Shandong Rainbow International Co., Ltd

Applicant ACN: N/A

Summary of Variation: To change the product name from ‘TORCH 75–D HERBICIDE’ to ‘RAINBOW PICLORAM

75–D HERBICIDE’







Product Name: RID Australia Medicated Rid Insect Repellent Antiseptic + Chamomille + Vitamin E

Pump Spray 4 Hours Mosquito Protection Neutral Scent Total Family Protection


160 g/L n,n-diethyl-m-toluamide (DEET), 20 g/L n-octyl bicycloheptene dicarboximide,

10 g/L di-n-propyl isocinchomeronate, 1 g/L triclosan



Summary of Variation: To change the product name from ‘MEDICATED RID REPELLENT PLUS

ANTISEPTIC PUMP SPRAY’ to ‘RID AUSTRALIA MEDICATED RID INSECT

REPELLENT ANTISEPTIC + CHAMOMILLE + VITAMIN E PUMP SPRAY 4

HOURS MOSQUITO PROTECTION NEUTRAL SCENT TOTAL FAMILY

PROTECTION’, add a pack size and to update label statements





Product Name: Homeguard PB Termite Moisture Barrier

Active Constituent/s: 1 g/kg bifenthrin

Applicant Name: FMC Australasia Pty Ltd


Summary of Variation: To change the product name from ‘HOMEGUARD BLUE TERMITE MOISTURE

BARRIER’ to ‘HOMEGUARD PB TERMITE MOISTURE BARRIER’ and to include

additional pack sizes





Product Name: Psyclop 750 SG Herbicide

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

Applicant Name: Sinon Australia Pty Limited


Summary of Variation: To change the product name from 'SINON LANTRAL 750 SG Herbicide' to 'PSYCLOP 750 SG HERBICIDE'





Product Name: Apparent Salvo 212 Herbicide

Active Constituent/s: 212 g/L fluazifop-P present as the butyl ester

Applicant Name: Apparent Pty. Ltd


Summary of Variation: To change the product name from 'APPARENT FLUAZIFOP-P 212 HERBICIDE' to 'APPARENT SALVO 212 HERBICIDE’







Product Name: Barmac Thiram DG Fungicide

Active Constituent/s: 800 g/kg thiram

Applicant Name: Amgrow Pty Ltd


Summary of Variation: To reduce the withholding period for strawberries from 7 days to 2 days





Product Name: AC Oxxel 240 EC Herbicide

Active Constituent/s: 240 g/L oxyfluorfen

Applicant Name: Axichem Pty Ltd


Summary of Variation: To add an additional pack size





Product Name: Whitestar Flutriafol 500 SC Fungicide

Active Constituent/s: 500 g/L flutriafol

Applicant Name: Agricultural Product Services Pty Ltd


Summary of Variation: To include suppression of net form net blotch in barley and to include higher rates of application associated with extended periods of control for uses in wheat and barley




3. VARIATION OF LABEL APPROVAL


Product name: Vivus Max Helicoverpa Biocontrol

Active constituent/s: 5 x 109 polyhedral inclusion bodies of the Nucleopolyhedrovirus of Helicoverpa armigera (native

isolate per millilitre

Applicant name: Agbitech Pty Ltd


Summary of variation: To add a low volume (10 L/ha) application rate for the control of Helicoverpa species in sorghum




Product name: Prosaro 420 SC Foliar Fungicide

Active constituent/s: 210 g/L prothioconazole, 210 g/L tebuconazole

Applicant name: Bayer Cropscience Pty Ltd


Summary of variation: To add additional general instruction statements and to rearrange the order of the restraints statements






Product name: Intervix Herbicide For Clearfield Crops

Active constituent/s: 33 g/L imazamox present as the ammonium salt, 15 g/L mazopyr present as the ammonium salt

Applicant name: BASF Australia Ltd


Summary of variation: To amend the tank mix partner details




Veterinary Chemical Products and Approved Labels



Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of

the registration in respect of the following products and has approved the label or varied the relevant particulars or

conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product Name: Barbervax Barber's Pole Worm Vaccine

Active Constituent/s: purified haemonchus contortus antigen; min 5 µg/mL

Applicant Name: Wormvax Australia Pty Ltd


Summary of use: For use as an aid in the control of Barber’s Pole worm in sheep and lambs by reducing egg shedding onto pasture





Product Name: Advantage Advocate For Dogs 10–25 Kg Fleas, Heartworm & Worms

Active Constituent/s: 25 g/L moxidectin, 100 g/L imidacloprid

Applicant Name: Bayer Australia Ltd (Animal Health)


Summary of use: For use in the treatment and prevention of fleas, the prevention of heartworm and the treatment and control of intestinal worms, sarcoptic mange, demodecticosis, lice and ear mites in dogs weighing 10–25kg





Product Name: Advantage Advocate For Dogs Over 25 Kg Fleas, Heartworm & Worms

Active Constituent/s: 25 g/L moxidectin, 100 g/L imidacloprid

Applicant Name: Bayer Australia Ltd (Animal Health)


Summary of use: For use in the treatment and prevention of fleas, the prevention of heartworm, the treatment and control of intestinal worms, sarcoptic mange, demodecticosis, lice and ear mites in dogs weighing over 25 kg







Product Name: Cephalexin 600 Tablets With Beef Flavouring

Active Constituent/s: 600 mg/Tb cephalexin (as cephalexin monohydrate)

Applicant Name: Apex Laboratories Pty Ltd


Summary of use: For the treatment of bacterial infections of the respiratory tract, genitourinary tract, musculoskeletal system, skin and soft tissues of dogs and cats





Product Name: Value Plus Folic Injection

Active Constituent/s: 15 mg/mL folic acid

Applicant Name: Ceva Animal Health Pty Ltd


Summary of use: For use in the treatment of macrocytic anaemia in horses and dogs





Product Name: Startect Broad Spectrum Oral Drench For Sheep

Active Constituent/s: 10 mg/mL derquantel, 1 mg/mL abamectin

Applicant Name: Zoetis Australia Pty Ltd


Summary of use: For the treatment and control of susceptible gastrointestinal nematodes of sheep, including those resistant to levamisole, benzimidazoles, macrocyclic lactones and closantel





Product Name: Vetmedin 10 mg Chewable Tablets For Dogs

Active Constituent/s: 10 mg/tb pimobendan

Applicant Name: Boehringer Ingelheim Pty Limited, Vetmedica Division


Summary of use: For initiation of treatment of congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid regurgitation) in dogs





Product Name: Exelpet Vet Series Total Tick Collar

Active Constituent/s: 90 g/kg amitraz

Applicant Name: Exelpet Products A Div Of Mars Australia Pty Ltd


Summary of use: For a 90 g/kg amitraz collar for the control of ticks, including dog paralysis tick ( Ixodes holocyclus and Ixodes cornuatus), bush tick (Haemophysalis logicornis), cattle tick (Rhipicephalus (Boophilus) microplus) and brown dog tick (Rhipicephalus sanguineus) in dogs for up to 2 months






2. VARIATIONS OF REGISTRATION


Product Name: Optiphos 10000 Liquid

Active Constituent/s: 6–phytase (I.U.B. 3.1.3.26): min 10000 FTU/mL

Applicant Name: Huvepharma AD

Applicant ACN: N/A

Summary of Variation: To extend claims for use to chickens and turkeys




Application No:

Product Name:

62225

Optiphos 5000 Liquid


Applicant Name:

6–phytase (I.U.B. 3.1.3.26): min 5000 FTU/mL

Huvepharma AD

Applicant ACN: N/A






Product Name: Optiphos 20000 Liquid

Active Constituent/s: 6–phytase (I.U.B. 3.1.3.26): min 20000 FTU/mL

Applicant Name: Huvepharma AD

Applicant ACN: N/A





3. VARIATION OF LABEL APPROVAL


Product Name: Pestigard Vaccine


≥106.7

TCID 50/dose of Bega and ≥107.5

TCID 50/dose of Trangie, Australian strains of Bovine Viral Diarrhoea Virus (BVDV)

Applicant Name: Zoetis Australia Pty Ltd


Summary of Variation: To include the prevention of nasal shedding due to Bovine pestivirus




Approved Active Constituents

Approved Active Constituents


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


Active constituent/s: Dithianon

Applicant name: Adama Australia Pty Limited


Summary of use: For use in agricultural chemical products

Date of approval: 14 October 2014

Approval no.: 68738


Active constituent/s: Fenamiphos

Applicant name: Amvac C.V

Applicant ACN: N/A



Approval no.: 70200


Active constituent/s: Hexaflumuron

Applicant name: Dow Agrosciences Australia Limited




Approval no.: 69897


Active constituent/s: Epoxiconazole

Applicant name: Jiangsu Flag Chemical Industry Co., Ltd

Applicant ACN: N/A



Approval no.: 70169


Active constituent/s: Metribuzin

Applicant name: Rallis India Limited

Applicant ACN: N/A



Approval no.: 70279


Cancellation of Label Approval at the Request of the Holder


At the request of the holder, the APVMA has cancelled a label approval for the following product:

Product no. Product name Approval holder Date of effect Cancelled label number

69203 TITAN ISOXAFLUTOLE 750 WG

HERBICIDE

TITAN AG PTY LTD 16 October 2014 69203/60236

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

SUPPLY

A person may supply or cause to be supplied product bearing the cancelled label manufactured prior to 16 October 2014

at wholesale and retail level, until 16 October 2015.

After 16 October 2015 it will be an offence against the Agvet Codes to have possession or custody of the product bearing

the cancelled label with the intention to supply, or to supply the product bearing the cancelled label

USE

A person may continue to use the product bearing the cancelled label according to its label instructions until 16 October

2015.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product in accordance with the

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

use or otherwise deal with the product bearing the cancelled label after the registration has been cancelled until

16 October 2015.

The supply and use of the product bearing the cancelled label must be in accordance with the conditions of registration

or approval, including any conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the product bearing the cancelled label listed in the table in

a manner that contravenes the above instructions.

APVMA CONTACT

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

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







67056 APPARENT FLUROXYPYR 200

HERBICIDE

APPARENT PTY. LTD. 10 October 2014 67056/55092


SUPPLY




the cancelled label with the intention to supply, or to supply the product bearing the cancelled label

USE

A person may continue to use the product bearing the cancelled label according to its label instructions until

10 October 2015.




10 October 2015.





APVMA CONTACT


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







68939 IMTRADE LIMBO 750 WG

HERBICIDE

IMTRADE AUSTRALIA

PTY LTD

22 October 2014 68939/59419


SUPPLY




the cancelled label with the intention to supply, or to supply the product bearing the cancelled label.

USE

A person may continue to use the product bearing the cancelled label according to its label instructions until

22 October 2015.




22 October 2015.





APVMA CONTACT


Chemical Review

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

SYMONSTON ACT 2609

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776




Cancellation of Approval at the Request of the Holder

Cancellation of Approval at the Request of the Holder

At the request of the holder, the APVMA has cancelled the approval of the following active constituent:

Active no. Active name Approval holder Date of effect

44383 FENTHION BAYER CROPSCIENCE PTY LTD 3 November 2014

REASONS

The holder of this approval has sent a written notice requesting the APVMA to cancel the approval. In accordance with

section 42 of the Agricultural and Veterinary Chemical Code scheduled to the Agricultural and Veterinary Chemical Code

Act 1994, the APVMA is satisfied that there are no valid reasons why it should not agree to this request and has

cancelled the approval of the active constituent 44383.

The following instructions set out how a person can deal with the cancelled active constituent.

INSTRUCTIONS

Manufacture or import of the listed active constituent after 3 November 2014 is not authorised.

Any person who possesses, has custody of, uses, or otherwise deals with the listed active constituent is taken to have

been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the active

constituent after the approval has been cancelled for a period of 12 months ending 2 November 2015.

After 2 November 2015 it will be an offence against the Agvet Codes to supply the active constituent, or to have

possession or custody of the active constituent with the intention to supply.

It is an offence to possess, have custody of, use, or deal with the active constituent listed in the table in a manner that

contravenes the above instructions.

APVMA CONTACT


Chemical Review


PO Box 6182

SYMONSTON ACT 2609

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776




Cancellation of the Registrations of Products and All Associated Labels Containing Fenthion due to the Voluntary Cancellation of the Active Constituent


The APVMA has cancelled the following product registrations and all associated labels:

Product no. Cancelled Product name Registrant holder Date of effect

32996 Lebaycid Insecticide Spray Bayer Cropscience Pty Ltd 3 November 2014

41138 Amalgamated Pest Control

Fenthion 1% Dust Insecticide

Amalgamated Pest Control Pty Ltd 3 November 2014

REASONS FOR THE CANCELLATION

At the request of the approval holder, the APVMA has cancelled the approval for the active constituent fenthion (approval

number 44383).

Section 44(1) of the Agricultural and Veterinary Chemical Code scheduled to the Agricultural and Veterinary Chemical

Code Act 1994 (the Agvet Code), states that if the APVMA cancels the approval of an active constituent for an existing

chemical product, it must also cancel any registration of that product.

Section 44(2) of the Agvet Code states that if the APVMA cancels the registration of a chemical product, it may also

cancel any approval relating to a label for containers for the chemical product.

Lebaycid Insecticide Spray (product number 32996), and Amalgamated Pest Control Fenthion 1% Dust Insecticide

(product number 41138) contain the active constituent fenthion (approval number). The APVMA has, therefore, cancelled

the registrations of these two products and all associated labels.

The following instructions set out how a person can deal with the cancelled products.

INSTRUCTIONS

Manufacture or import of the listed products after 3 November 2014 is not authorised.

Any person who possesses, has custody of, uses, or otherwise deals with the cancelled products may possess, have

custody of, use or otherwise deal with the product in accordance with the instructions in this notice only for a period of

12 months ending 2 November 2015.

After 2 November 2015 it will be an offence against the Agvet Codes to supply these products, or to have possession or

custody of these products with the intention to supply.

SUPPLY

Products manufactured prior to 3 November 2014 may be supplied or cause to be supplied, at wholesale and retail level

only until 2 November 2015.

After 2 November 2015 it will be an offence against the Agvet Codes to supply these products, or to have possession or

custody of these products with the intention to supply.



USE

Any person who possesses, has custody of, uses, or otherwise deals with the listed products in accordance with the

instructions in this notice, is taken to have been issued with a permit under the Agvet Codes to so possess, have custody

of, use or otherwise deal with the products after the registration has been cancelled until 2 November 2015.

The supply and use of the products must be in accordance with the conditions of registration or approval, including any

conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the products listed in the table in a manner that

contravenes the instructions in this notice. Specific instructions are provided below:

Product Number 41138 Amalgamated Pest Control Fenthion 1% Dust Insecticide

Label Instructions for use Use prohibited after:

41138/0900

(cancelled 16 October 2014)

Must only be used according to the instructions on the label

15 October 2015

41138/1208

(varied 16 October 2014)


15 October 2015

41138/1014

(cancelled 3 November 2014)


2 November 2015

Product Number 32996 Lebaycid Insecticide Spray bearing the listed label approval numbers

Label Approval Instructions for use Use prohibited after:

32996/0110

(varied 30 October 2014)

This label has been varied as a result of the review of fenthion. Product bearing this label must only be used according to the instructions in the Special Gazette Notice of 16 October 2014, or in conjunction with any instructions contained in permits issued by the APVMA.

29 October 2015

32996/1014

(cancelled 3 November 2014)


2 November 2015

WARNING

A person must not possess with the intent to supply, or deal with the cancelled products except in accordance with the

instructions contained in this notice. A failure to comply with them will result in an offence against the Agvet Codes and

the APVMA will take appropriate compliance action. It will be an offence for any person to possess with the intent to

supply, or deal with the products after 2 November 2015.

APVMA CONTACT


Chemical Review


PO Box 6182

SYMONSTON ACT 2609

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776




Exemption from Offence Provisions

Exemption from Offence Provisions

EXMEPTION FOR THE PURPOSES OF SECTION 75 AND SECTION 78

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has determined, as provided for under sections 75(1)(b) and 78(1)(b) of the Schedule to the Agricultural and Veterinary Chemical Code Act 1994 (the Agvet Code), that

the products listed below are exempt from the operation of section 75 and section 78 of the Agvet Code. Products subject to this exemption

1. Zagrosol AD3E (oral solution)

2. Amilyte (water soluble powder)

3. Nilstress (water soluble powder)

4. Zagrosol Minpro (oral solution)

5. Zagrosol Aminogen (oral solution)

6. Calpozag (oral solution)

This exemption is granted for the period of 7 October 2014 to 7 March 2014 inclusive. While in force this exemption means that while the products are veterinary chemicals, as defined by section 5 of the Agvet Code, and unregistered, it is not an offence to possess them for the purposes of supply or to supply them. This exemption can be cancelled or amended at any time by the APVMA.

APVMA CONTACT

For further information please contact:

Director

Compliance and Monitoring Section


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4796

Fax: +61 2 6210 4813




Amendments to the APVMA MRL Standard

Amendments to the APVMA MRL Standard

The Australian Pesticides and Veterinary Medicines Authority (APVMA) approves maximum residue limits (MRLs) of

agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. The MRLs

approved by the APVMA are associated with a regulatory decision to register a product, grant a permit approval, or as an

outcome from a review decision and are set out in the Agricultural and Veterinary Chemicals Code Instrument No. 4

(MRL Standard) 2012. The MRL Standard lists MRLs of substances that may arise from the approved use of agricultural

and veterinary chemical products containing those substances on commodities used for human consumption as well as

livestock feeds. The MRL Standard also provides the relevant residue definitions to which these MRLs apply. There may

be situations where the residue definition for monitoring and enforcement is different to the definition used for dietary risk

assessment purposes.

MRLs are set at levels which are not likely to be exceeded if the agricultural or veterinary chemicals are used in

accordance with approved label instructions. In considering MRLs and variation to MRLs, the APVMA takes into account

studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice and dietary

exposure. In approving MRLs, the APVMA is satisfied, from dietary exposure assessment, that the levels set are not an

undue hazard to human health.

The APVMA has amended the MRL Standard with affect from 4 November 2014.

Details of the amendment can be found in the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL

Standard) Amendment Instrument 2014 (No. 10).

The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code Instrument

No. 4 (MRL Standard) 2012.

The MRL Standard is accessible via the ComLaw website www.comlaw.gov.au or the links above.


MRL Contact Officer


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4897

Fax: +61 2 6210 4840


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

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

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



Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code


In the previous notice, the APVMA gazetted that amendments which it has approved varying maximum residue limits

(MRLs) for substances contained in agricultural and veterinary chemical products as set out as in the APVMA’s MRL

Standard, have been made.

Under Section 82 of the Food Standards Australia New Zealand Act 1991 the APVMA is proposing to incorporate those

variations (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2014

(No. 10)) to MRLs into Standard 1.4.2. Maximum Residue Limits of the Australia New Zealand Food Standards Code.

MRLs contained in Standard 1.4.2 provide the limits for residues of agricultural and veterinary chemicals that may

legitimately occur in foods. By this means, Standard 1.4.2 permits the sale of treated foods and protects public health

and safety by minimising residues in foods consistent with the effective control of pests and diseases.

The APVMA and FSANZ are satisfied, based on dietary exposure assessments and current health standards, that the

proposed limits are not harmful to public health.

The Agreement between the Government of Australia and the Government of New Zealand concerning a Joint Food

Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food

standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary

chemicals in food.

Food Standards Australia New Zealand (FSANZ) will make a Sanitary and Phytosanitary (SPS) notification to the World

Trade Organization (WTO).

The APVMA invites comment on these proposals. Details on how to make a submission appear near the end of this

notice, below the details of the proposed amendment.

The APVMA will consider any public comments made in response to this proposal. If the APVMA decides to proceed with

the proposal, it will further notify any variations it makes to Standard 1.4.2 in the APVMA Gazette. The variations will take

effect as from the date of that subsequent notice.



DRAFT VARIATIONS TO THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE

Note: The following amendments are in a format that accords with the proposed amending Legislative Instrument

which, in turn, has to be consistent with the existing format of Standard 1.4.2 (Maximum Residue Limits) of the

Australia New Zealand Food Standards Code.

PROPOSED AMENDMENT (AGRICULTURAL AND VETERINARY CHEMICALS CODE INSTRUMENT NO. 4 (MRL

STANDARD) AMENDMENT INSTRUMENT 2014 (NO. 10))

Note: Subsection 82(2) of the Food Standards Australia New Zealand Act 1991 provides that variations to standards

are legislative instruments, but are not subject to disallowance or sunsetting.

To commence: on gazettal of variation Standard 1.4.2 of the Australia New Zealand Food Standards Code is varied by –

1. inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals

Azamethiphos

Azamethiphos

Edible offal (mammalian) *0.05 Meat (mammalian) *0.05 Milks *0.05

Chlorothalonil

Commodities of plant origin: Chlorothalonil Commodities of animal origin: 4-hydroxy-2,5,6-

trichloroisophthalonitrile metabolite, expressed as chlorothalonil

Lettuce, head T10 Lettuce, leaf T10

Clothianidin

Clothianidin

Olives T0.5

Emamectin

Sum of emamectin B1a and emamectin B1b

Beetroot T0.05 Leafy vegetables [except lettuce

head; lettuce leaf; mizuna] T0.5

Parsnip T0.05 Radish T0.05 Swede T0.05 Turnip, Garden T0.05

Ethephon

Ethephon

Banana T*0.05

Propiconazole

Propiconazole

Gai Ium T1

Triadimenol

Triadimenol see also Triadimefon

Chives T3 Leek T3 Onion, Chinese T3 Onion, Welsh T3 Shallot T3 Spring onion T3



2. omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –

3. omitting from Schedule 1, under the entries for the following chemicals, the maximum residue limit for the food, substituting –

Emamectin


Mizuna T0.5

Methomyl

Methomyl

Onion, Welsh T2 Shallot T2 Spring onion T2

Propiconazole

Propiconazole

Chicory leaves T1 Endive T1 Radicchio T1

Emamectin


Brassica leafy vegetables T0.3 Chervil T0.05 Rucola (rocket) T0.05

Propiconazole

Propiconazole

Brassica leafy vegetables T0.7



INVITATION FOR SUBMISSIONS

Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the

proposal to vary Standard 1.4.2 Maximum Residue Limits of the Australia New Zealand Food Standards Code.

Submissions should be strictly confined to relevant matters that the APVMA must consider (such as public health and

safety) which are associated with the occurrence of the proposed residues in foods. Comments received outside these

grounds will not be considered by the APVMA. Claims made in submissions should be supported wherever possible by

referencing or including relevant studies, research findings, trials, surveys etc. Technical information should be in

sufficient detail to allow independent scientific assessment.

Please note that FSANZ will make a SPS notification to the WTO and submissions related to impacts on international

trade should be made to FSANZ in response to that notification.

Submissions must be made in writing and should be clearly marked as a ‘submission on the proposed amendment to

Standard 1.4.2’ and quote the correct amendment number.

DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (AEDT) 2 December 2014 SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL ONLY BE CONSIDERED BY PRIOR ARRANGEMENT

Submissions received after this date will only be considered if agreement for an extension has been given prior to this

closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to

the submission period.


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


Documents

APVMA Gazette No. 22, 4 November 2014 · 11/4/2014 · Commonwealth of Australia Gazette No. APVMA 22, Tuesday, 4 November 2014 Agricultural and Veterinary Chemicals Code Act 1994