apvma gazette no. 12, 16 june 2015 · no. apvma 12, tuesday, 16 june 2015 ... public affairs and...

No. APVMA 12, Tuesday, 16 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 12, Tuesday, 16 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: [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 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/.

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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.

mailto:[email protected]

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

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


CONTENTS

Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and Approved Labels .................................................................................................... 20 Approved Active Constituents ....................................................................................................................................... 26 Amendments to the APVMA MRL Standard .................................................................................................................. 27 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code ............................................ 28 Approval under section 14A of the Agvet Code Act of a New Agricultural Active Constituent Megasphaera elsdenii (strain 41125) ................................................................................................................................................................ 32 Cancellation of Approval at the Request of the Holder .................................................................................................. 33


Agricultural Chemical Products and Approved Labels


Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals

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

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

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

1. RESTRICTED PRODUCT

Application no.: 101296

Product name: Termi-Tite Termite Barrier

Active constituent/s: 5.2 g/kg bifenthrin

Applicant name: The White Ant Co. Pty. Ltd

Applicant ACN: 100 706 009

Summary of use For use as a barrier against concealed subterranean termite entry when used

with concrete slab-on ground and cavity brickwork, suspended timber floors and

retaining walls

Date of registration/approval: 4 June 2015

Product registration no.: 80622

Label approval no.: 80622/101296

2. AGRICULTURAL PRODUCTS BASED ON NEW ACTIVE CONSTITUENT


Product name: Luna Privilege Fungicide

Active constituent/s: 500 g/L fluopyram

Applicant name: Bayer Cropscience Pty Ltd


Summary of use For the control of botrytis bunch rot and powdery mildew in table grapes and grapes for dried fruit production




3. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Singleshot Gel Cockroach Insecticide

Active constituent/s: 21.5 g/kg imidacloprid

Applicant name: Sulphur Mills Australia Pty Limited


Summary of use For control of cockroaches in farm buildings, factories, homes, hospitals, restaurants, schools, transport facilities and other urban situations as described in the directions for use

Date of registration/approval: 13 May 2015






Product name: Antero Miticide/Insecticide

Active constituent/s: 500 g/L diafenthiuron

Applicant name: Cheminova Australia Pty Limited


Summary of use For control of two-spotted mite and cotton aphid and suppression of silverleaf white fly in cotton





Product name: Accensi Imazapic 240 Herbicide

Active constituent/s: 240 g/L imazapic present as the ammonium salt

Applicant name: Accensi Pty Ltd


Summary of use For the pre-emergence control of certain annual grass and broadleaf weeds in fallow situations, sugarcane and peanuts, and early post-emergence control of certain annual grass and broadleaf weed in peanuts and sugarcane





Product name: Ultrasil Chlorine Free Sanitiser

Active constituent/s: 595 g/L hydrogen peroxide, 0.5 g/L silver as silver nitrate

Applicant name: Waterco Limited


Summary of use To sanitise pools and spas





Product name: Pearl Systemic Fungicide

Active constituent/s: 200 g/L penconazole

Applicant name: Agrinova New Zealand Limited T/A Gro-Chem

Applicant ACN: N/A

Summary of use For the control of certain diseases in apples, pears and grapevines





Product name: eChem Clopyralid 750 Herbicide

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

Applicant name: eChem (Aust) Pty Limited


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







Product name: Weed Force Renovate Herbicide

Active constituent/s: 600 g/kg metsulfuron methyl

Applicant name: Weed Force Pty Ltd


Summary of use For the control of brush and broadleaf weeds in a variety of situations





Product name: Accensi Bromoxynil / Diflufenican 250/25 Selective Herbicide

Active constituent/s: 250 g/L bromoxynil present as the octanoate, 25 g/L diflufenican



Summary of use For the control of certain broadleaf weeds in winter cereals and pastures





Product name: Wellfarm Epoxiconazole 125 SC Fungicide

Active constituent/s: 125 g/L epoxiconazole

Applicant name: Wellfarm Pty Ltd


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





Product name: Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling

Active constituent/s: 1018 g/L cuprous oxide

Applicant name: New Nautical Coatings, Inc

Applicant ACN: N/A

Summary of use For use as an antifouling paint to control marine growth below the waterline on vessels





Product name: Sea Hawk Premium Yacht Finishes Premium Quality AF33 Eroding Antifouling

Active constituent/s: 624 g/L cuprous oxide

Applicant name: New Nautical Coatings, Inc

Applicant ACN: N/A

Summary of use For use as an antifouling paint to control marine growth below the waterline on vessels







Product name: Foragemax Herbicide

Active constituent/s: 100 g/L halauxifen as the methyl ester, 50 g/L aminopyralid as the triisopropylamine salt

Applicant name: Dow Agrosciences Australia Limited


Summary of use For the post emergent control of broadleaf weeds in forage brassicas





Product name: Clincher Gold Herbicide

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

Applicant name: Adama Australia Pty Limited


Summary of use For the control of certain annual grasses and broadleaf weeds in various crops





Product name: Wellfarm MCPA Amine 500 SL Herbicide

Active constituent/s: 500 g/L MCPA present as the dimethylamine salt



Summary of use For selective control of broadleaf weeds in cereals, linseed, pastures, sugarcane and turf





Product name: Growers Lawn Grubber Concentrate

Active constituent/s: 5 g/L imidacloprid

Applicant name: Grow Choice Pty Limited


Summary of use For use in the home garden to kill and control curl bug, billbug larvae, African black beetle

and beetles





Product name: Wellfarm Halosulfuron 750 WG Herbicide

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



Summary of use For the selective post-emergence control of nutgrass in sugarcane, corn/maize, sorghum, nutgrass and mullumbimby couch in turf and nutgrass in cotton using shielded sprayers







Product name: Orbit 290 SL Insecticide

Active constituent/s: 290 g/L omethoate (an anticholinesterase compound)



Summary of use For the control of redlegged earth mite, blue oat mite and lucerne flea on various crops and bluegreen aphid and cowpea aphid on pasture legumes, lucerne, faba beans and vetch





Product name: Guardian Red Seed Treatment Insecticide


Applicant name: Chemtura Australia Pty Ltd


Summary of use For the control of various insect pests in a range of crops, protection against insect pests of stored cereal grains and the prevention of spread of barley yellow dwarf virus in cereal crops





Product name: Pacman Growth Regulator

Active constituent/s: 250 g/L paclobutrazol

Applicant name: Crop Culture Pty Ltd


Summary of use For reduction of vegetative growth in mango, stone fruit and apple trees




4. VARIATIONS OF REGISTRATION

Application no: 102352

Product name: Apparent Decimator 400 Insecticide

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

Applicant name: Apparent Pty. Ltd


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘APPARENT DIMETHOATE 400 INSECTICIDE’ to ‘APPARENT DECIMATOR 400 INSECTICIDE’

Date of variation: 22 April 2015






Product name: Apparent Weedy Seedy 250 Herbicide

Active constituent/s: 115 g/L diquat present as diquat dibromide, 135 g/L paraquat present as paraquat dichloride



Summary of variation: To change the distinguishing and the name that appears on the label from ‘APPARENT PARAQUAT 135 + DIQUAT 115 HERBICIDE’ to ‘APPARENT WEEDY SEEDY 250 HERBICIDE’





Product name: Motac 500 SC Fungicide

Active constituent/s: 500 g/L carbendazim

Applicant name: Sumitomo Chemical Australia Pty Limited


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘SUMITOMO MOTAC 500 SC FUNGICIDE’ to ‘MOTAC 500 SC FUNGICIDE’





Product name: Apparent Cocky 200 SC Insecticide




Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘APPARENT IMIDACLOPRID 200 SC INSECTICIDE’ to ‘APPARENT COCKY 200 SC INSECTICIDE’





Product name: Apparent Swoosh 125 Sc Fungicide

Active constituent/s: 125 g/L epoxiconazole



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘APPARENT EPOXICONAZOLE 125 SC FUNGICIDE’ to ‘APPARENT SWOOSH 125 SC FUNGICIDE’







Product name: Apparent Whirlwind 430 Fungicide

Active constituent/s: 430 g/L tebuconazole



Summary of variation: To change the distinguishing product and the name that appears on the label from ‘APPARENT TEBUCONAZOLE 430 FUNGICIDE’ to ‘APPARENT WHIRLWIND 430 FUNGICIDE’





Product name: Apparent Expunge 600 SC Insecticide




Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘APPARENT IMIDACLOPRID 600 SC INSECTICIDE’ to ‘APPARENT EXPUNGE 600 SC INSECTICIDE’





Product name: Apparent Matey 290 Insecticide

Active constituent/s: 290 g/L omethoate (an anticholinesterase compound)



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘APPARENT OMETHOATE 290 INSECTICIDE’ to ‘APPARENT MATEY 290 INSECTICIDE’





Product name: Apparent Weedshot 200 Herbicide

Active constituent/s: 200 g/L glufosinate-ammonium



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘APPARENT GLUFOSINATE-AMMONIUM 200 HERBICIDE’ to ‘APPARENT WEEDSHOT 200 HERBICIDE’







Product name: Apparent Sword 750 WG Herbicide

Active constituent/s: 750 g/kg chlorsulfuron



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

Date of variation: 1 May 2015




Product name: Apparent Bayonet 750 WG Herbicide

Active constituent/s: 750 g/kg triasulfuron



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





Product name: Macro Protect Platinum Spray Tank Adjuvant

Active constituent/s: 704 g/L methyl & ethyl esters of fatty acids from refined canola

Applicant name: Macrofertil Australia Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RAVENSDOWN PLATNUM SPRAY TANK ADJUVANT’ to ‘MACRO PROTECT PLATINUM SPRAY TANK ADJUVANT’





Product name: Macro Protect Assist Spray Tank Adjuvant

Active constituent/s: 859 g/L petroleum oil

Applicant name: Macrofertil Australia Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RAVENSDOWN ASSIST SPRAY TANK ADJUVANT’ to ‘MACRO PROTECT ASSIST SPRAY TANK ADJUVANT’







Product name: Apparent Shatter 750 WG Herbicide

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



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





Product name: Apparent Annihilate 100 Duo Insecticide

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



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘APPARENT ALPHA-CYPERMETHRIN 100 DUO INSECTICIDE’ to ‘APPARENT ANNIHILATE 100 DUO INSECTICIDE’





Product name: Richgro Beat-A-Bug Natural Possum Deterrent Poss Off

Active constituent/s: 4 ml/L capsicum oleoresin, 0.25 ml/L garlic, 1 ml/L citronella oil

Applicant name: A. Richards Pty Ltd T/A Richgro Garden Products


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RICHGRO BEAT-A-BUG POSS OFF NATURAL POSSUM DETERRENT’ to ‘RICHGRO BEAT-A-BUG NATURAL POSSUM DETERRENT POSS OFF’





Product name: Panoctine Liquid Fungicide

Active constituent/s: 400 g/L guazatine acetates

Applicant name: Crop Care Australasia Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘NUFARM PANOCTINE LIQUID FUNGICIDE’ to ‘PANOCTINE LIQUID FUNGICIDE’







Product name: Apparent Fate Fumigation Tablets

Active constituent/s: 330 g/kg phosphine (ph3) present as aluminium phosphide



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘APPARENT PHOSPHINE FUMIGATION TABLETS’ to ‘APPARENT FATE FUMIGATION TABLETS’





Product name: Apparent Check Mate 500 Herbicide

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

Applicant name: Apparent Pty. Ltd.


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘APPARENT TRIALLATE 500 HERBICIDE’ to ‘APPARENT CHECK MATE 500 HERBICIDE’





Product name: Graziers Tebulex 200GR Herbicide

Active constituent/s: 200 g/kg tebuthiuron

Applicant name: Ronic International Pty Limited


Summary of variation: To add an additional state, SA, for the use on African Boxthorn





Product name: Glister 680SG Herbicide

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

Applicant name: Sinon Australia Pty Limited


Summary of variation: To add a pack size of 540 kg (36 x 15 kg)





Product name: Glister 360 Herbicide

Active constituent/s: 360 g/L glyphosate present as the isopropylamine salt

Applicant name: Sinon Australia Pty Limited


Summary of variation: To add a pack range of 1 L-1000 L







Product name: Mortein Naturgard Multi-Insect Automatic Spray Indoor Eucalyptus

Household Protection

Active constituent/s: 8.0 g/kg permethrin, 6.0 g/kg transfluthrin

Applicant name: Reckitt Benckiser (Australia) Pty Limited


Summary of variation: To change the name of the product from ‘MORTEIN NATURGARD AUTO PROTECT INDOOR

EUCALYPTUS HOUSEHOLD PROTECTION’ to ‘MORTEIN NATURGARD MULTI-INSECT AUTOMATIC SPRAY INDOOR EUCALYPTUS HOUSEHOLD PROTECTION’





Product name: Mortein Naturgard Multi-Insect Automatic Spray Indoor Odourless

Active constituent/s: 8.0 g/kg permethrin, 6.0 g/kg transfluthrin



Summary of variation: To change the name of the product from ‘MORTEIN NATURGARD AUTO PROTECT

INDOOR ODOURLESS’ to ‘MORTEIN NATURGARD MULTI-INSECT AUTOMATIC SPRAY INDOOR ODOURLESS’





Product name: Nufarm Avadex Xtra Selective Herbicide

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

Applicant name: Nufarm Australia Limited


Summary of variation: To increase the use rate up to 3.2 L/ha when used in wheat, barley, triticale and canola to control Group D resistant ryegrass and Group A resistant wild oats populations





Product name: Leaf-Guard Spray Adjuvant

Active constituent/s: 754 g/L ethyl and methyl esters of canola oil

Applicant name: Victorian Chemical Company Proprietary Limited


Summary of variation: To change the distinguishing product name and the approved label name from ‘BLAST SPRAY ADJUVANT’ to ‘LEAF-GUARD SPRAY ADJUVANT’







Product name: Checkout Turf Growth Regulator

Active constituent/s: 120 g/L trinexapac-ethyl



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘NUFARM CHECKOUT TURF GROWTH REGULATOR’ to ‘CHECKOUT TURF GROWTH REGULATOR’





Product name: Lepidex 500 Insecticide

Active constituent/s: 500 g/L trichlorfon (an anticholinesterase compound)



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘NUFARM LEPIDEX 500 INSECTICIDE’ to ‘LEPIDEX 500 INSECTICIDE’





Product name: Velpar L Herbicide

Active constituent/s: 250 g/L hexazinone



Summary of variation: To change the distinguishing name and the name that appears on the label from ‘DUPONT VELPAR L HERBICIDE’ to ‘VELPAR L HERBICIDE’





Product name: Apparent Deathcap 250 Fungicide

Active constituent/s: 250 g/L iprodione



Summary of variation: To change the distinguishing name and the name that appears on the label from ‘APPARENT IPRODIONE 250 FUNGICIDE’ to ‘APPARENT DEATHCAP 250 FUNGICIDE’





Product name: Lawn Solutions Australia Grub Guard Premium Pest Control For Lawns

Active constituent/s: 1 g/L esfenvalerate

Applicant name: Amgrow PTY LTD


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘LAWN LOVERS GRUB GUARD PREMIUM PEST CONTROL FOR LAWNS’ to ‘LAWN SOLUTIONS AUSTRALIA GRUB GUARD PREMIUM PEST CONTROL FOR LAWNS’







Product name: Fast Action Roundup Ready To Use Weedkiller

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

Applicant name: Monsanto Australia Ltd


Summary of variation: To add a pack size range of 200 mL–5 L

Date of variation: 9 June 2015




Product name: Broadstrike Herbicide

Active constituent/s: 800 g/kg flumetsulam

Applicant name: Dow Agrosciences Australia Limited


Summary of variation: To remove the claim for pigeon pea and update the re-cropping period in cotton




Product name: Bobcat I-Maxx Herbicide

Active constituent/s: 25 g/L imazapic as the ammonium salt, 125 g/L hexazinone, 25 g/L n-methyl pyrrolidone 250 g/L hydrocarbon liquid



Summary of variation: To extend the re-cropping intervals




Product name: Thin-It Blossom Thinner

Active constituent/s: 782 g/L ammonium thiosulphate

Applicant name: Agrinova New Zealand Limited T/A Gro-Chem

Applicant ACN: N/A

Summary of use: To add tank mix with Gro-Wet Low Volume Application Spreader for use

at concentrated water volume in Royal Gala apples

Date of approval: 27 May 2015



Product name: Acramite Miticide

Active constituent/s: 480 g/L bifenazate

Applicant name: Chemtura Australia Pty Ltd


Summary of variation: To extend the use to certain fruiting vegetable crops, papaya and strawberries







Product name: Mortein Fast Knockdown Fly & Mosquito Killer Low Allergenic Household Protection

Active constituent/s: 2.41 g/kg bioallethrin



Summary of variation: To change product name from ‘MORTEIN FLY & MOSQUITO KILLER

FAST KNOCKDOWN LOW ALLERGENIC’ to ‘MORTEIN FAST KNOCKDOWN

FLY & MOSQUITO KILLER LOW ALLERGENIC HOUSEHOLD PROTECTION’

and add 200 g, 320 g, 340 g and 370 g pack sizes





Product name: Mortein Fast Knockdown Fly & Mosquito Killer Odourless

Active constituent/s: 1.1 g/kg esbiothrin, 0.5 g/kg permethrin



Summary of variation: To change the product name from ‘MORTEIN FLY & MOSQUITO KILLER

FAST KNOCKDOWN ODOURLESS’ to ‘MORTEIN FAST KNOCKDOWN FLY &

MOSQUITO KILLER ODOURLESS’





Product name: Ultrateb 750 WG Fungicide

Active constituent/s: 750 g/kg tebuconazole

Applicant name: Sumil Chemical Industries PVT Ltd

Applicant ACN: N/A

Summary of variation: To add claims to direction of use





Product name: Cosamil Fungicide Miticide

Active constituent/s: 800 g/kg sulfur (s) as wettable sulfur


Applicant ACN: N/A

Summary of variation: To add additional pack sizes







Product name: Brimflo 800 G/L Fungicide and Miticide

Active constituent/s: 800 g/L sulphur


Applicant ACN: N/A

Summary of variation: To add additional pack sizes





Product name: Deccozil EC Fungicide

Active constituent/s: 240 g/L imazalil

Applicant name: UPL Australia Limited


Summary of variation: To extend the label claims to include post-harvest control of blue mould in

apples and pears





Product name: AC Hacksaw Herbicide

Active constituent/s: 750 g/kg metribuzin

Applicant name: Axichem Pty Ltd


Summary of variation: To extend use to include sugarcane





Product name: Radiate Termiticide

Active constituent/s: 100 g/L fipronil

Applicant name: FMC Australasia Pty Ltd


Summary of variation: To add additional uses for pre- and post-construction to control termites





Product name: Regular Roundup Ready To Use Weedkiller

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

Applicant name: Monsanto Australia Ltd


Summary of variation: To add a pack size range of 200 mL–5 L







Product name: Titan Wetter 1000 Wetting Agent

Active constituent/s: 1000 g/L non-ionic alcoholated alkoxylate

Applicant name: Titan AG Pty Ltd


Summary of variation: To include additional pack sizes and update label





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: Glyde Mobility Chews For Dogs

Active constituent/s: Each chew contains 285 mg chondroitin sulfate sodium (bovine origin), 570 mg glucosamine hydrochloride, 760 mg green lipped mussel powder

Applicant name: Parnell Technologies Pty Ltd


Summary of use For improvement of joint health and function in dogs





Product name: Vets Choice For Dogs 10–25 Kg Fleas


Applicant name: Bayer Australia Ltd (Animal Health)


Summary of use For the control of fleas on large dogs. Larval flea stages are killed in the surroundings of treated pets. Reduces the incidence of flea allergy dermatitis. For the control of lice (Trichodectes canis, Linognathus setosus) on dogs





Product name: M-Eloxyn 20 mg/mL Solution for Injection

Active constituent/s: 20mg/mL meloxicam

Applicant name: Zoetis Australia Pty Ltd


Summary of use For use as a non-steroidal anti-inflammatory, analgesic and antipyretic in cattle and pigs





Product name: Vets Choice For Dogs Over 25 Kg Fleas




Summary of use For the control of fleas on large dogs. Larval flea stages are killed in the

surroundings of treated pets. Reduces the incidence of flea allergy dermatitis.

For the control of lice (Trichodectes canis, Linognathus setosus) on large dogs







Product name: Vets Choice For Dogs 4–10 Kg Fleas




Summary of use For the control of fleas on dogs. Larval flea stages are killed in the surroundings

of treated pets. Reduces the incidence of flea allergy dermatitis. For the control

of lice (Trichodectes canis, Linognathus setosus) on dogs





Product name: Ingelvac Mycoflex Mycoplasma Hyopneumoniae Inactivated Vaccine For Pigs

Active constituent/s: Each 1 mL dose contains inactivated Mycoplasma hyopneumoniae ≥1 RP, 1 mg carbomer

Applicant name: Boehringer Ingelheim Pty Limited, Vetmedica Division


Summary of use For the vaccination of healthy, susceptible swine at weaning (3 weeks of age) or older as an aid in the prevention of enzootic pneumonia of swine caused by Mycoplasma hyopneumoniae





Product name: Enzaprost T Injection

Active constituent/s: 5 mg/mL dinoprost (as dinoprost trometamol)

Applicant name: Ceva Animal Health Pty Ltd


Summary of use For oestrus control and to aid in the control of reproduction dependent on a corpus luteum





Product name: Tilmicabs AC (Tilmicosin Phosphate) Aqueous Concentrate

Active constituent/s: 250 mg/mL tilmicosin (as tilmicosin phosphate)

Applicant name: Abbey Laboratories Pty Ltd


Summary of use For the treatment of pneumonia in pigs caused by Actinobacillus pleuropneumoniae, Actinomyces pyogenes, Mycoplasma hyopneumoniae, Pasteurella multocida and other bacteria sensitive to tilmicosin







Product name: SkinTraction

Active constituent/s: 70 g/L sodium lauryl sulphate

Applicant name: Cobbett Technologies Pty Ltd


Summary of use For use as an intradermal sclerosing agent in sheep ≥12 months of age and ≥30 kg bodyweight to increase the bare area around the breech





Product name: Fortekor Plus 1.25 mg Pimobendan/2.5 mg Benazepril HCI For Dogs

Active constituent/s: Each tablet contains 1.25 mg pimobendan, 2.5 mg benazepril hydrochloride

Applicant name: Novartis Animal Health Australasia Pty. Limited


Summary of use For use in treatment of congestive heart failure in dogs





Product name: Fortekor Plus 5 mg Pimobendan/10 mg Benazepril HCI For Dogs

Active constituent/s: Each tablet contains 5mg pimobendan, 10 mg benazepril hydrochloride

Applicant name: Novartis Animal Health Australasia Pty. Limited


Summary of use For use in treatment of congestive heart failure in dogs





Product name: Topizole Medicated Shampoo

Active constituent/s: 20 g/L chlorhexidine gluconate, 20 g/L miconazole nitrate

Applicant name: Mavlab Pty. Ltd


Summary of use For the topical treatment of non-specific dermatological conditions in dogs and cats





Product name: NutriBAC 150G Feed Additive Premix

Active constituent/s: 150 g/kg zinc bacitracin

Applicant name: Nutriment Health Pty Ltd


Summary of use For the treatment of and as an aid in the prevention of necrotic enteritis in poultry







Product name: Apex Doxy 100 Paste

Active constituent/s: Each gram contains 100 mg doxycycline (as monohydrate)

Applicant name: Apex Laboratories Pty Ltd


Summary of use For the treatment of bacterial infections of the skin, upper and lower respiratory tract, genitourinary tract, middle ear, skeletal system and gastrointestinal tract of cats





Product name: Technyflex Feline

Active constituent/s: 500 mg/capsule green lipped mussel powder (Perna canaliculus)

Applicant name: Natural Health New Zealand 2002 Limited

Applicant ACN: N/A

Summary of use For help in the relief of arthritic symptoms in cats




2. VARIATIONS OF REGISTRATION


Product name: Aristopet Animal Health Tea Tree Flea Powder For Dogs And Puppies

Active constituent/s: 10 g/kg piperonyl butoxide, 1.5 g/kg pyrethrins

Applicant name: Aristopet Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘ARISTOPET ANIMAL HEALTH FLEA POWDER FOR DOGS AND PUPPIES’ to ‘ARISTOPET ANIMAL HEALTH TEA TREE FLEA POWDER FOR DOGS AND PUPPIES’





Product name: Aristopet Animal Health Tea Tree Flea And Tick Shampoo For Dogs And Puppies

Active constituent/s: 10 g/L piperonyl butoxide, 1 g/L pyrethrins

Applicant name: Aristopet Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘ARISTOPET ANIMAL HEALTH FLEA AND TICK SHAMPOO FOR DOGS AND PUPPIES’ to ‘ARISTOPET ANIMAL HEALTH TEA TREE FLEA AND TICK SHAMPOO FOR DOGS AND PUPPIES’





Veterinary Chemical Products and approved labels


Product name: Apex Amoxycillin - 400 Broad-Spectrum Antibiotic Tablets

Active constituent/s: 400 mg amoxycillin (as amoxycillin trihydrate)

Applicant name: Apex Laboratories Pty Ltd


Summary of variation: To change the distinguishing name of the product and the name that appears on the label from ‘AMOXYCILLIN - 400 BROAD SPECTRUM ANTIBIOTIC TABLETS’ to ‘APEX AMOXYCILLIN - 400 BROAD-SPECTRUM ANTIBIOTIC TABLETS’





Product name: Paw Pure Animal Wellbeing By Blackmores Cosequin Equine Powder Concentrate

Active constituent/s: 1800 mg/3.3 g scoop glucosamine hydrochloride, 600 mg/3.3 g scoop sodium chondroitin sulfate

Applicant name: Blackmores Limited

Applicant ACN: 009713437

Summary of variation: To change the distinguishing name from ‘COSEQUIN EQUINE POWDER CONCENTRATE’ to ‘PAW PURE ANIMAL WELLBEING BY BLACKMORES COSEQUIN EQUINE POWDER CONCENTRATE’




Product name: Paw Pure Animal Wellbeing By Blackmores Cosequin Ds Double Strength Sprinkle Capsules For Large Dogs

Active constituent/s: 400 mg/capsule sodium chondroitin sulfate, 500 mg/capsule glucosamine hydrochloride

Applicant name: Blackmores Limited


Summary of variation: To change the distinguishing product name from ‘DOUBLE STRENGTH COSEQUIN DS DOUBLE STRENGTH SPRINKLE CAPSULES FOR LARGE DOGS’ to ‘PAW PURE ANIMAL WELLBEING BY BLACKMORES COSEQUIN DS DOUBLE STRENGTH SPRINKLE CAPSULES FOR LARGE DOGS’




Product name: Methodyne Injection

Active constituent/s: 10 mg/mL methadone hydrochloride

Applicant name: Jurox Pty Limited


Summary of variation: To extend the use of the product to cats





Veterinary Chemical Products and approved labels

3. VARIATION OF LABEL APPROVAL


Product name: Tridoxine Injection

Active constituent/s: 200 mg/mL sulfadoxine, 40 mg/mL trimethoprim

Applicant name: Jurox Pty Limited


Summary of variation: To vary the label particulars to add in-use shelf life, trade advice and first aid statement

Date of variation: 56464



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: Indoxacarb

Applicant name: TGAC Australia Pty Ltd


Summary of use: For use in agricultural chemical products

Date of approval: 13 May 2015

Approval no.: 80102


Active constituent/s: Fluopyram




Date of approval: 1 June 2015

Approval no.: 63735


Active constituent/s: Quinclorac





Approval no.: 67914


Active constituent/s: 2,4-D

Applicant name: UPL Australia Limited




Approval no.: 70214


Active constituent/s: Dichlorprop

Applicant name: Grow Choice Pty Limited




Approval no.: 70072


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 and the changes will have affect the day after the instrument is registered.

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

(MRL Standard) Amendment Instrument 2015 (No. 5).

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

No. 4 (MRL Standard) 2012.

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

For further information please contact:

MRL Contact Officer

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4897

Fax: +61 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 2015

(No. 5)) 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 2015 (NO. 5))

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 –

Acifluorfen

Acifluorfen

Chia T*0.01

Difenoconazole

Difenoconazole

Poppy seed T*0.01

Pirimicarb Sum of pirimicarb, demethyl-pirimicarb and the N-

formyl-(methylamino) analogue (demethylformamido-pirimicarb), expressed as pirimicarb

Celery T15

Vegetables [except adzuki bean (dry); celeriac; celery; leafy vegetables; lupin (dry); mung bean (dry); onion, Welsh; shallot; soya bean (dry); spring onion; sweet corn (corn-on-the-cob)]

1

Pymetrozine

Pymetrozine

Leafy vegetables T5

Sedaxane

Sedaxane, sum of isomers

Poppy seed T*0.01

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

Pirimicarb

Sum of pirimicarb, demethyl-pirimicarb and the N-formyl-(methylamino) analogue (demethylformamido-

pirimicarb), expressed as pirimicarb

Vegetables [except adzuki bean (dry); celeriac; leafy vegetables; lupin (dry); mung bean (dry); onion, Welsh; shallot; soya bean (dry); spring onion; sweet corn (corn-on-the-cob)]

1



Pymetrozine

Pymetrozine

Leafy vegetables [except mizuna] T5

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

Benzyladenine

Benzyladenine

Pear *0.005

Dimethoate

Sum of dimethoate and omethoate, expressed as dimethoate

see also Omethoate

Egg plant T0.2

Fluopyram Commodities of plant origin: Fluopyram

Commodities of animal origin: Sum of fluopyram and

2-(trifluoromethyl)-benzamide, expressed as fluopyram

Almonds 0.05

Cherries 3

Edible offal (mammalian) 0.2

Meat (mammalian) *0.02

Milks *0.02

Pome fruits 0.5

Stone fruits [except cherries] 2

Penflufen

Penflufen

Potato *0.01

Pirimicarb Sum of pirimicarb, demethyl-pirimicarb and the N-

formyl-(methylamino) analogue (demethylformamido-pirimicarb), expressed as pirimicarb

Onion, Welsh T7

Shallot T7

Spring onion T7

Terbuthylazine

Terbuthylazine

Cotton seed 0.01

Trifloxystrobin

Sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)-

ethylideneaminooxymethyl]phenyl] acetic acid), expressed as trifloxystrobin equivalents

Almonds 0.05

Stone fruits 5



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 (AEST) 14 July 2015

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

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

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

the submission period.

For further information please contact:

MRL Contact Officer


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4897

Fax: +61 2 6210 4840




Approval under section 14A of the Agvet Code Act of a New Agricultural Active Constituent Megasphaera elsdenii (strain 41125)

Approval under section 14A of the Agvet Code Act of a New Agricultural Active Constituent Megasphaera elsdenii (strain 41125)

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a

new active constituent, Megasphaera elsdenii strain 41124.

Active Name: Megasphaera elsdenii

IUPAC Name: N/A

CAS Name: N/A

CAS Registry Number: N/A

Minimum Purity: N/A

Molecular Formula: N/A

Molecular Weight: N/A

Structure: N/A

SUMMARY OF THE APVMA’S EVALUATION OF MEGASPHAERA ELSDENII STRAIN 41125

The Chemistry and Manufacture Section of the APVMA has evaluated Megasphaera elsdenii strain 41125 and found it to

be acceptable during the evaluation of the associated product LACTICON. A Public Release Statement has been published

that encompassed this active and was open for comment with the approval of the associated product.

In the Toxicological assessment of Megasphaera elsdenii strain 41125 the Office of Chemical Safety stated:

Megasphaera elsdenii is naturally found in the rumen of cattle and sheep, and in the gastrointestinal tract of non-

ruminant mammals, including humans. No member of the taxonomic group containing Megasphaera elsdenii are

known to be pathogenic or toxic.

Upon transitioning from predominately roughage-based diets to starch-based diets, livestock may experience

potentially fatal or sub-acute rumen acidosis, with lactic acid production by other ruminant bacteria being a major

contributor to the ruminal acid load. M. elsdenii assists this transition by metabolising ruminal lactic acid. The

inoculation is self-limiting, as M. elsdenii levels return to normal after a few weeks when lactate production rates

normalise.

The Office of Chemical Safety has considered the toxicological aspects of Megasphaera elsdenii strain 41125, and advised

that there are no toxicological objections to the approval of this bacteria.

The APVMA accepts the findings and recommendations of the Office of Chemical Safety.

The APVMA is satisfied that the proposed use of Megasphaera elsdenii strain 41125 would not be an undue toxicological

hazard to the safety of people exposed to it during its handling and use and fulfils the statutory requirements of Section

14A of the Agvet Code Act of 1994.


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

63535 GLYPHOSATE ISOPROPYLAMINE

MANUFACTURING CONCENTRATE

CP MANUFACTURING SDN BHD 3 June 2015

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

SUPPLY

A person may supply or cause to be supplied active constituent manufactured prior to 3 June 2015 at wholesale and

retail level, until the 3 June 2016.

After 3 June 2016 it will be an offence against the Agvet Codes to have possession or custody of the active constituent

with the intention to supply, or to supply the active constituent.

USE

Any person who possesses, has custody of, uses, or otherwise deals with the listed active constituent 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 active constituents after the approval has been cancelled until 3 June 2016.

The supply and use of the active constituents must be in accordance with the conditions of 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 active constituents 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


PO Box 6182

SYMONSTON ACT 2609

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776



apvma gazette no. 12, 16 june 2015 · no. apvma 12, tuesday, 16 june 2015 ... public affairs and...

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