APVMA Gazette No. 7, 10 April 2018 · Product name: Loveland Products Radiate Growth Promotant...

No. APVMA 7, Tuesday, 10 April 2018

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 7, Tuesday, 10 April 2018 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2018

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any

process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and

inquiries concerning reproduction and rights should be addressed to:

Director, Public Affairs and Communications

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

Kingston ACT 2604

Email: [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 A PVMA, 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/news-and-publications/publications/gazette

If you would like to receive email notification when a new edition is published, please subscribe on the APVMA website.

APVMA CONTACTS

For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4812

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/news-and-publications/publications/gazette


CONTENTS

Agricultural Chemical Products and Approved Labels................................................................................................. 4 Veterinary Chemical Products and Approved Labels ................................................................................................ 12 Approved Active Constituents.................................................................................................................................. 14 Approved Active Constituents—s14A ...................................................................................................................... 16 Approved Active Constituents—s14 ......................................................................................................................... 33 Cancellation of Product Label Approval at the Request of the Holder ........................................................................ 36 Cancelation of Registration and Associated Labels of Vet Only Trubin L-50 Growth Promotant for Pigs (35806) Notice Under s45A(1)(b) and s45A(3) of the Agvet Code .................................................................................................... 37 Affirmation of Product Registration and Associated Labels Notice Under s34AC(1)(b) of the Agvet Code................... 38 Amendments to the APVMA MRL Standard ............................................................................................................. 41 Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code ............................................... 42


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.: 113988

Product name: Apparent Triceratops 700 WG Herbicide

Active constituent/s: 700 g/kg imazamox

Applicant name: Apparent Pty Ltd

Applicant ACN: 143 724 136

Summary of use: For the post-emergence control of certain annual grasses and broadleaf weeds in field

peas, legume-based pastures, lucerne, peanuts, and soybeans

Date of registration: 16 March 2018

Product registration no.: 85750

Label approval no.: 85750/113988


Product name: Accensi Imidacloprid 600 FS Flowable Seed Dressing

Active constituent/s: 600 g/L imidacloprid

Applicant name: Accensi Pty Ltd


Summary of use: For the control of insects in crops and the prevention of barley yellow dwarf virus in

cereal crops





Product name: Loveland Products Radiate Growth Promotant

Active constituent/s: 8.84 g/L indole-3-butyric acid

Applicant name: Loveland Products Inc

Applicant ACN: N/A

Summary of use: For the promotion of plant growth in various situations





Product name: Supa-Wet Tx Ope Surfactant

Active constituent/s: 1040 g/L octyl phenol ethoxylate

Applicant name: Australian Adjuvants Pty Ltd


Summary of use: For use with herbicides when treating annual ryegrass, silvergrass and perennial grasses







Product name: 4Farmers Tebuconazole 800WG Fungicide

Active constituent/s: 800 g/kg tebuconazole

Applicant name: 4 Farmers Australia Pty Ltd


Summary of use: For the control of various fungal diseases on bananas, peanuts, cereal crops, beans,

peas, onions, pawpaw, pyrethrum and ryegrass and fescue seed crops





Product name: Mortein Powergard Flying Insect Killer Odourless

Active constituent/s: 0.9 g/kg d-allethrin, 0.9 g/kg d-phenothrin, 3.15 g/kg tetramethrin

Applicant name: Reckitt Benckiser (Australia) Pty Limited


Summary of use: For the control of flies, mosquitoes, moths, cockroaches, ants, spiders, fleas and

silverfish





Product name: Sharda Clethodim 240 Herbicide

Active constituent/s: 240 g/L clethodim

Applicant name: Sharda Cropchem Espana SL

Applicant ACN: N/A

Summary of use: For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas,

cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans





Product name: Titan S-metolachlor+ Prosulfocarb Herbicide

Active constituent/s: 800 g/L prosulfocarb, 120 g/L s-metolachlor

Applicant name: Titan Ag Pty Ltd


Summary of use: For control of annual and broadleaf weeds in barley and wheat





Product name: Genfarm Bifenthrin 250 EC Insecticide / Miticide

Active constituent/s: 250 g/L bifenthrin

Applicant name: Landmark Operations Limited


Summary of use: For the control of insects and mites on fruit, vegetables and field crops







Product name: Kenso Agcare Prairie 755 Herbicide

Active constituent/s: 755 g/L triclopyr present as the butoxyethanol ester

Applicant name: Kenso Corporation (M) Sdn Bhd

Applicant ACN: N/A

Summary of use: For the control of woody weeds and melons





Product name: Kenso Agcare Ken-Up Grand 450 CT Non-Selective, Translocated Herbicide

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

Applicant name: Kenso Corporation (M) Sdn Bhd

Applicant ACN: N/A

Summary of use: For the control of annual and perennial grasses and broadleaf weeds prior to crop

establishment and as an aid to pasture management





Product name: Surefire Insignia 250 EC Fungicide

Active constituent/s: 250 g/L pyraclostrobin

Applicant name: PCT Holdings Pty Ltd


Summary of use: For the control of leaf speckle, leaf spot and black sigatoka in bananas, downy and

powdery mildew in grapevines, husk spot in macadamia and rust in almond





Product name: Masterole Insecticide

Active constituent/s: 240 g/L methoxyfenozide

Applicant name: Shandong Rainbow International Co Ltd

Applicant ACN: N/A

Summary of use: For use on food crops





Product name: Wipe-Out Dry 800 SG Herbicide

Active constituent/s: 800 g/kg glyphosate present as the ammonium salt

Applicant name: Adama Australia Pty Limited


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







Product name: EmuAg Glyphosate 450 Herbicide

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

Applicant name: EmuAg Pty Ltd


Summary of use: For the control of most emerged weeds and plants




2. VARIATIONS OF REGISTRATION


Product name: Exirel Insecticide

Active constituent/s: 100 g/L cyantraniliprole

Applicant name: FMC Australasia Pty Ltd


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

Date of variation: 29 January 2018




Product name: Accensi Alpha-Cypermethrin 100 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 ‘COUNTRY ALPHA-CYPERMETHRIN 100 INSECTICIDE’ to ‘ACCENSI ALPHA-

CYPERMETHRIN 100 INSECTICIDE’

Date of variation: 20 February 2018




Product name: Fufarm Glyphosate 360 SL Herbicide

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

Applicant name: Fufarm Co Pty Ltd


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

from ‘EASYFARM GLYPHOSATE 360 SL HERBICIDE’ to ‘FUFARM GLYPHOSATE 360 SL HERBICIDE’







Product name: Nimbus WG Fungicide/Miticide

Active constituent/s: 800 g/kg sulphur (S) as sulphur

Applicant name: Grochem Australia Pty Ltd



from ‘MELPAT SULPHUR WG FUNGICIDE/ MITICIDE’ to ‘NIMBUS WG FUNGICIDE/MITICIDE’





Product name: Accensi Fenamiphos 400 Nematicide Liquid

Active constituent/s: 400 g/L fenamiphos (an anti-cholinesterase compound)



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘COUNTRY FENAMIPHOS 400 NEMATICIDE LIQUID’ to ‘ACCENSI

FENAMIPHOS 400 NEMATICIDE LIQUID’





Product name: Starling Fungicide

Active constituent/s: 230 g/L fludioxonil

Applicant name: Grochem Australia Pty Ltd



from ‘MELPAT STARLING FUNGICIDE’ to ‘STARLING FUNGICIDE’





Product name: Express Herbicide

Active constituent/s: 750 g/kg tribenuron methyl

Applicant name: FMC Australasia Pty Ltd



from ‘DUPONT EXPRESS HERBICIDE’ to ‘EXPRESS HERBICIDE’







Product name: Nufarm Dictate 480 Post-Emergence Herbicide

Active constituent/s: 480 g/L bentazone (present as sodium salt)

Applicant name: Nufarm Australia Limited



from ‘CROP CARE DICTATE 480 POST-EMERGENCE HERBICIDE’ to ‘NUFARM DICTATE 480 POST-EMERGENCE HERBICIDE’

Date of variation: 2 March 2018




Product name: Imtrade Loxy 900 EC Herbicide

Active constituent/s: 900 g/L haloxyfop present as the haloxyfop-p methyl ester

Applicant name: Imtrade Australia Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘FIREPOWER 900 HERBICIDE’ to ‘IMTRADE LOXY 900 EC HERBICIDE’





Product name: Chateau Herbicide

Active constituent/s: 500 g/kg flumioxazin

Applicant name: Sumitomo Chemical Australia Pty Limited


Summary of variation: To update safety statements on the label





Product name: Coliseum Herbicide

Active constituent/s: 250 g/kg rimsulfuron

Applicant name: Turf Culture Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘TURF CULTURE COLISEUM HERBICIDE’ to ‘COLISEUM HERBICIDE’





Product name: Ascent Liquid Acid Dairy Detergent

Active constituent/s: 1100 g/L phosphoric acid

Applicant name: Tasman Chemicals Pty Limited


Summary of variation: To approve a new label for the product 'ASCENT LIQUID ACID DAIRY DETERGENT '

with the label name 'ELIMINATOR LIQUID ACID DAIRY DETERGENT'







Product name: Thumper Insecticide

Active constituent/s: 20 g/L abamectin

Applicant name: Turf Culture Pty Ltd


Summary of variation: To remove a redundant label direction that states not to use with organosilicone-based

surfactants





Product name: Lightning Herbicide

Active constituent/s: 525 g/kg imazethapyr, 175 g/kg imazapyr

Applicant name: BASF Australia Ltd


Summary of variation: To increase the recommended water volume per hectare





Product name: Surefire Spectrum 350 SC Soil Insecticide

Active constituent/s: 350 g/L imidacloprid

Applicant name: PCT Holdings Pty Ltd


Summary of variation: To extend the use to include additional canegrub species in current situations,

additional use in plant cane crops, use in potato crops, use in apple and citrus tree crops, and add a new size range





Product name: Applaud Insecticide

Active constituent/s: 440 g/L buprofezin

Applicant name: Dow Agrosciences Australia Limited


Summary of variation: To reduce the withholding period for tomatoes (protected crop) from 7 days WHP to 3 days WHP





Product name: Prodone 500SC Fungicide

Active constituent/s: 500 g/L procymidone

Applicant name: Ruralco Holdings Limited


Summary of variation: To correct the rate for faba beans from 50 mL/ha to 500 mL/ha.







Product name: Eco2fume Phosphine Fumigant

Active constituent/s: 20 g/kg phosphine

Applicant name: Cytec Australia Holdings Pty Limited


Summary of variation: To extend the use to control rusty grain beetle, including strongly resistant strains, in

cereal grain and other commodities





Product name: Vaporph3os Phosphine Fumigant

Active constituent/s: 990 g/kg phosphine

Applicant name: Cytec Australia Holdings Pty Limited


Summary of variation: To extend the use to control rusty grain beetle, including strongly resistant strains, in

cereal grain and other commodities





Product name: Yates Weed N' Feed Hose On

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

dimethylamine salt

Applicant name: Duluxgroup (Australia) Pty Ltd


Summary of variation: To amend statement of claims, restraints and other label instructions





Product name: Sumi-Alpha Flex Insecticide

Active constituent/s: 50 g/L esfenvalerate

Applicant name: Sumitomo Chemical Australia Pty Limited


Summary of variation: To extend uses in turf to control African black beetle, funnel ants, armyworm, billbug,

blackheaded pasture cockchafer, couch mite, cutworm, wingless grasshopper and webworm





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: Lactipro Advance

Active constituent/s: 2 x 108 CFU/ml Megasphaera elsdenii

Applicant name: BEC Biotech Pty Ltd


Summary of use: For use in cattle (beef, dairy and calves) and sheep to aid in the transition from

roughage to grain rations





Product name: Milpro Film Coated Tablets For Dogs

Active constituent/s: 125 mg/Tb praziquantel, 12.5 mg/Tb milbemycin oxime

Applicant name: Virbac (Australia) Pty Ltd


Summary of use: For oral use in the treatment and control of roundworms, hookworms, whipworm and

tapeworms, and for prevention of heartworm in dogs





Product name: Troy Anaeway Injection

Active constituent/s: 200 mg/mL iron (as iron dextran) 40 μg/mL cyanocobalamin

Applicant name: Troy Laboratories Pty Ltd


Summary of use: For the treatment and control of iron deficiency anaemia in piglets





Product name: Exacta Dual Action Oral Drench For Sheep

Active constituent/s: 82.5 g/L levamisole hydrochloride (equivalent to 70.0 g/L levamisole), 36.0 g/L albendazole oxide (equivalent to 34.0 g/L albendazole)

Applicant name: The Hunter River Company Pty Limited


Summary of use: For the control of gastrointestinal roundworms sensitive to benzimidazoles and levamisole including those resistant to either benzimidazoles or levamisole in sheep.

Also for control of lungworm and tapeworm, and reducing the output of viable worm eggs in sheep






2. VARIATIONS OF REGISTRATION


Product name: Alfaxan Multidose Anaesthetic Injection

Active constituent/s: 10 mg/mL alfaxalone

Applicant name: Jurox Pty Limited



from ‘ALFAXAN MULTI ANAESTHETIC INJECTION’ to ‘ALFAXAN MULTIDOSE ANAESTHETIC INJECTION’





Product name: Applemax LV Liquid Broad Spectrum Wormer And Boticide For Horses

Active constituent/s: 10 mg/mL ivermectin

Applicant name: Abbey Laboratories Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘ZEROMEC LV LIQUID BROAD SPECTRUM WORMER & BOTICIDE FOR

HORSES’ to ‘APPLEMAX LV LIQUID BROAD SPECTRUM WORMER AND BOTICIDE FOR HORSES’





Product name: Independents Own Uranus Spray-On Sheep Blowfly Treatment

Active constituent/s: 60 g/L cyromazine

Applicant name: Apparent Pty. Ltd.


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘INDEPENDENTS OWN VENUS SPRAY-ON SHEEP BLOWFLY TREATMENT’

to ‘INDEPENDENTS OWN URANUS SPRAY-ON SHEEP BLOWFLY TREATMENT’





Product name: Independents Own Uranus Sheep Blowfly Treatment

Active constituent/s: 500 g/L cyromazine

Applicant name: Apparent Pty. Ltd.



from ‘INDEPENDENTS OWN VENUS SHEEP BLOWFLY TREATMENT’ to ‘INDEPENDENTS OWN URANUS SHEEP BLOWFLY TREATMENT’





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 CONSTITUENT


Active constituent/s: Propyzamide

Applicant name: Imtrade Australia Pty Ltd


Summary of use: For use in agricultural chemical products

Date of approval: 21 March 2018

Approval no.: 84971


Active constituent/s: S-Metolachlor

Applicant name: Hextar Chemicals Pty Ltd




Approval no.: 84467


Active constituent/s: Imidacloprid

Applicant name: Hextar Chemicals Pty Ltd




Approval no.: 85081


Active constituent/s: Imazalil

Applicant name: Janssen Pharmaceutica N.V.

Applicant ACN: N/A



Approval no.: 85037


Active constituent/s: Chlorpyrifos-methyl

Applicant name: Dow Agrosciences Australia Limited




Approval no.: 85030




Active constituent/s: Indoxacarb

Applicant name: Jingbo Agrochemicals Technology Co., Ltd

Applicant ACN: N/A



Approval no.: 84866


Approved Active Constituents—s14A



Code Act 1994, s14A, 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.



Active constituent/s: Trimethoprim

Applicant name: Ausrichter Pty Ltd


Summary of use: For use in veterinary chemical products

Date of approval: 12 January 2018

Approval no.: 84788


Active constituent/s: Monensin Sodium

Applicant name: Elanco Australasia Pty Ltd




Approval no.: 84914


Active constituent/s: Sulfadimidine

Applicant name: Ausrichter Pty Ltd




Approval no.: 85748


Active constituent/s: Cloprostenol Sodium

Applicant name: Intervet Australia Pty Limited




Approval no.: 84942


Active constituent/s: Monensin Sodium





Approval no.: 84915




Active constituent/s: Cloprostenol Sodium

Applicant name: Randlab Australia Pty Ltd




Approval no.: 84829


Active constituent/s: Testosterone Propionate





Approval no.: 85022


Active constituent/s: Polymyxin B Sulphate





Approval no.: 84995


Active constituent/s: Bupivacaine Hydrochloride

Applicant name: Bayer Australia Ltd (Animal Health)




Approval no.: 85034


Active constituent/s: Lignocaine





Approval no.: 85040


Active constituent/s: Butorphanol Tartrate

Applicant name: Zoetis Australia Pty Ltd




Approval no.: 85064




Active constituent/s: Levamisole Hydrochloride

Applicant name: Kato Laboratories Pty Ltd




Approval no.: 85091


Active constituent/s: Thiamine Disulfide Nitrate

Applicant name: Ceva Animal Health Pty Ltd




Approval no.: 84369


Active constituent/s: Neomycin Sulphate





Approval no.: 85079


Active constituent/s: Meloxicam





Approval no.: 85095


Active constituent/s: Phytomenadione (Vitamin K1)

Applicant name: Mavlab Pty. Ltd



Date of approval: 5 February 2018

Approval no.: 83764


Active constituent/s: Oxfendazole





Approval no.: 85137




Active constituent/s: Florfenicol





Approval no.: 84815


Active constituent/s: Eprinomectin





Approval no.: 84599


Active constituent/s: Ivermectin





Approval no.: 85140


Active constituent/s: Cetrimide





Approval no.: 85146


Active constituent/s: Praziquantel





Approval no.: 85096


Active constituent/s: Hydroxocobalamin Acetate





Approval no.: 85148




Active constituent/s: Piperonyl Butoxide





Approval no.: 85174


Active constituent/s: Amoxycillin Trihydrate





Approval no.: 85183


Active constituent/s: Progesterone





Approval no.: 85182


Active constituent/s: Butaphosphan





Approval no.: 85181


Active constituent/s: L-Isoleucine





Approval no.: 84646


Active constituent/s: Robenacoxib





Approval no.: 84998




Active constituent/s: Lasalocid Sodium





Approval no.: 85761


Active constituent/s: Hydroxocobalamin Acetate





Approval no.: 85149


Active constituent/s: Magnesium Sulphate Heptahydrate





Approval no.: 85177


Active constituent/s: Omeprazole

Applicant name: Equestra Pty Ltd




Approval no.: 85208


Active constituent/s: Novobiocin Sodium





Approval no.: 84989


Active constituent/s: Dihydrostreptomycin





Approval no.: 85078




Active constituent/s: Naphthalophos





Approval no.: 85080


Active constituent/s: Magnesium Hypophosphite





Approval no.: 85175


Active constituent/s: Glutamic Acid-L Sodium Salt





Approval no.: 85155


Active constituent/s: Vitamin B2 = Riboflavin





Approval no.: 85156


Active constituent/s: Arginine-L Hydrochloride





Approval no.: 85233


Active constituent/s: Lysine-L Hydrochloride





Approval no.: 85239




Active constituent/s: Thiamine Hydrochloride





Approval no.: 85249


Active constituent/s: Florfenicol

Applicant name: Laboratorios Hipra S.A.

Applicant ACN: N/A



Approval no.: 85242


Active constituent/s: N-Octyl Bicycloheptene Dicarboximide





Approval no.: 85194


Active constituent/s: Superfine Oat Flour





Approval no.: 83787


Active constituent/s: Avena Sativa (Oat) Kernel Flour





Approval no.: 83788


Active constituent/s: Gonadorelin As Gondorelin Acetate





Approval no.: 85271




Active constituent/s: Propylene Glycol





Approval no.: 85270


Active constituent/s: Methionine-DL





Approval no.: 85255


Active constituent/s: Streptomycin Sulphate





Approval no.: 85265


Active constituent/s: Deslorelin Acetate

Applicant name: Caledonian Holdings Distribution Pty Ltd




Approval no.: 85250


Active constituent/s: Oestradiol





Approval no.: 85274


Active constituent/s: Dimethyl Sulfoxide





Approval no.: 85253




Active constituent/s: Inositol





Approval no.: 85256


Active constituent/s: Cod Liver Oil





Approval no.: 85218


Active constituent/s: Disodium Zinc EDTA





Approval no.: 84564







Approval no.: 83577


Active constituent/s: Disodium Manganese EDTA





Approval no.: 83578


Active constituent/s: Disodium Copper EDTA





Approval no.: 83581




Active constituent/s: Disodium Cobalt EDTA





Approval no.: 84277







Approval no.: 84566







Approval no.: 84627







Approval no.: 84654


Active constituent/s: Disodium Cobalt EDTA





Approval no.: 84565


Active constituent/s: Selamectin

Applicant name: Norbrook Laboratories Australia Pty Limited




Approval no.: 85288




Active constituent/s: Polymyxin B Sulfate

Applicant name: Bocko P/L & Flexsky P/L (In Partnership) T/A Pharmachem

Applicant ACN: 57 147 389 678



Approval no.: 83975


Active constituent/s: Chlortetracycline Hydrochloride (Feed Grade Granulated)

Applicant name: CCD Animal Health Pty Ltd




Approval no.: 84948


Active constituent/s: Chlortetracycline Hydrochloride (20% Granular)

Applicant name: CCD Animal Health Pty Ltd




Approval no.: 84956







Approval no.: 85298







Approval no.: 85301







Approval no.: 86004









Approval no.: 85299







Approval no.: 85908


Active constituent/s: Procaine Penicillin





Approval no.: 85302


Active constituent/s: Procaine Penicillin





Approval no.: 85960


Active constituent/s: Beta Cyfluthrin





Approval no.: 85019


Active constituent/s: Cyanocobalamin

Applicant name: Merial Australia Pty Ltd




Approval no.: 85001




Active constituent/s: Sulphadimidine





Approval no.: 85336


Active constituent/s: Sulphadimidine

Applicant name: Troy Laboratories Pty Ltd




Approval no.: 85335


Active constituent/s: Moxidectin





Approval no.: 85368


Active constituent/s: Chlorpheniramine Maleate

Applicant name: Apex Laboratories Pty Ltd




Approval no.: 85415


Active constituent/s: Tulathromycin





Approval no.: 85332


Active constituent/s: Isoflurane





Approval no.: 85334




Active constituent/s: Doxycycline Monohydrate





Approval no.: 85333


Active constituent/s: Moxidectin





Approval no.: 85417







Approval no.: 84930







Approval no.: 84985


Active constituent/s: Bismuth Subnitrate





Approval no.: 85087


Active constituent/s: Bismuth Subnitrate





Approval no.: 85437









Approval no.: 85924


Active constituent/s: Oleandomycin Phosphate





Approval no.: 85331


Active constituent/s: Sulphadiazine





Approval no.: 85337


Active constituent/s: Triflumuron





Approval no.: 85347


Active constituent/s: Tylosin Phosphate




Date of approval: 3 April 2018

Approval no.: 86042


Active constituent/s: Imidacloprid

Applicant name: Abbey Laboratories Pty Ltd



Date of approval: 5 April 2018

Approval no.: 84993



2. VARIATIONS OF ACTIVE CONSTITUENT


Active constituent/s: Flunixin Meglumine

Applicant name: Neove Pharma Australia Pty Limited


Summary of variation: Variation of relevant particulars or conditions of an approved active constituent


Approval no.: 82735


Approved Active Constituents—s14



Code Act 1994, s14, 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.


N/A

2. VARIATIONS OF ACTIVE CONSTITUENT


Active constituent/s: Bacitracin Zinc

Applicant name: Huvepharma EOOD

Applicant ACN: N/A



Approval no.: 82610


Active constituent/s: Amoxycillin Trihydrate





Approval no.: 81892







Approval no.: 82725







Approval no.: 82725


Active constituent/s: Isoeugenol

Applicant name: Aqui-S New Zealand Limited

Applicant ACN: N/A



Approval no.: 55639









Approval no.: 54999







Approval no.: 54999







Approval no.: 82185







Approval no.: 82185


Active constituent/s: Miconazole Nitrate





Approval no.: 55840


Active constituent/s: Romifidine Hydrochloride

Applicant name: Boehringer Ingelheim Pty Limited, Vetmedica Division




Approval no.: 52658









Approval no.: 82547


Active constituent/s: Tylosin Tartate





Approval no.: 82541


Active constituent/s: Doramectin

Applicant name: Merial Australia Pty Ltd




Approval no.: 82295


Active constituent/s: Benazepril Hydrochloride





Approval no.: 54737


Cancellation of Product Label Approval at the Request of the Holder

Cancellation of Product Label Approval at the Request of the Holder

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

Product

no.

Product name Registrant Product label

approval

number

Date of effect

67882 Crop Culture Ancestor

Insecticide

Crop Culture Pty Ltd 67882/57022 21 March 2018

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

SUPPLY

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

21 March 2018 at wholesale and retail level, until the 21 March 2019.

After 21 March 2019 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.

USE

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

21 March 2019.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product bearing the cancelled label

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 until 21 March 2019.

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


PO Box 6182

SYMONSTON ACT 2609 Phone: +61 2 6210 4779

Fax: +61 2 6210 4776




Cancelation of Registration and Associated Labels of Vet Only Trubin L-50 Growth Promotant for Pigs (35806)—Notice Under

s45A(1)(b) and s45A(3) of the Agvet Code

Cancelation of Registration and Associated Labels of Vet Only Trubin L-50 Growth Promotant for Pigs (35806)

Notice Under s45A(1)(b) and s45A(3) of the Agvet Code

On 29 March 2018, the APVMA:

1. Cancelled the registration of the product listed in Table 1 under s34AA(1) of the Agricultural and Veterinary

Chemicals Code Act 1994 (Agvet Code); and

2. Cancelled the approval of the associated product labels (those listed in Column 4 of Table 1) under s44(2) of the

Agvet Code.

Table 1: Product containing active constituent kitasamycin

Product number Product name Holder Cancelled label approvals

35806 VET ONLY TRUBIN L-50

GROWTH PROMOTANT

FOR PIGS

COUNTRY VET

WHOLESALING PTY LTD

35806/113630

35806/53433

35806/48865

35806/0498

35806/01

BRIEF STATEMENT OF REASONS

The registration of this product has been cancelled because the APVMA was not satisfied that it met the safety criteria or

that the relevant particulars or conditions of this product can be varied in such a way as to allow the registration to be

affirmed.

INSTRUCTIONS FOR POSSESSING, HAVING CUSTODY OF, OR USING THE PRODUCT

The APVMA has determined under s45A and s45B of the Agvet Code that a one year period from the date of this decision

shall apply for possessing, having custody of or using VET ONLY TRUBIN L-50 GROWTH PROMOTANT FOR PIGS

(35806) bearing cancelled labels. During this time VET ONLY TRUBIN L-50 GROWTH PROMOTANT FOR PIGS may

continue to be used according to the instructions appearing on the cancelled labels.

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 4773






Affirmation of Product Registration and Associated Labels Notice Under s34AC(1)(b) of the Agvet Code

On 29 March 2018, the APVMA:

1. Affirmed the registration of the tylosin products listed below in Table 1 under s34(1) of the Agricultural and Veterinary

Chemicals Code Act 1994 (Agvet Code); and

2. Affirmed the approval of labels for containers of the tylosin products listed below.

3. Determined under s81(3) of the Agvet Code that a one year period from the date of this decision shall apply for the

continued supply and use of registered products bearing earlier approved labels.

Table 1: Product registrations and label approvals affirmed

Product

number

Product name Registration holder Label approvals

varied

New distinguishing

number of varied label

36790 ELANCO AF0091 TYLAN

100 TYLOSIN

PHOSPHATE PREMIX

ELANCO

AUSTRALASIA PTY

LTD

36790/107498 36790/RV0318A


50 TYLOSIN

PHOSPHATE PREMIX

ELANCO

AUSTRALASIA PTY

LTD

36791/107462 36791/RV0318B


250 TYLOSIN

PHOSPHATE PREMIX

ELANCO

AUSTRALASIA PTY

LTD

36806/107042 36806/RV0318C

45175 LIENERT TYLAN 50

PREMIX

ALLTECH LIENERT

AUSTRALIA PTY LTD

45175/62500 45175/RV0318D

53703 TYLOMIX 100 TYLOSIN

TARTRATE PREMIX

ABBEY

LABORATORIES PTY

LTD

53703/0502 53703/RV0318E

53752 TYLECO 250

GRANULAR

INTERNATIONAL

ANIMAL HEALTH

PRODUCTS PTY LTD

53752/55127 53572/RV0318F

54573 TYLECO 50 GRANULAR INTERNATIONAL

ANIMAL HEALTH

PRODUCTS PTY LTD

54573/61777 54573/RV0318G

59908 TYLODOX 250 DOX-AL AUSTRALIA

PTY LTD

59908/55915 59908/RV0318H

60283 CCD TYLOSIN 100

(TYLOSIN PHOSPHATE)

PREMIX

CCD ANIMAL HEALTH

PTY LTD

60283/1207 60283/RV0318I

60891 TYLODOX 50 G

MICROGRANULATE

FEED ADDITIVE

DOX-AL AUSTRALIA

PTY LTD

60891/55916 60891/RV0318J




Product

number

Product name Registration holder Label approvals

varied

New distinguishing

number of varied label


GRANULAR TYLOSIN

PHOSPHATE

ELANCO

AUSTRALASIA PTY

LTD

61525/110285 61525/RV0318K

61913 PHARMASIN 250

GRANULAR PREMIX

HUVEPHARMA EOOD 61913/0809 61913/RV0318L

61977 PHARMASIN 100

GRANULAR PREMIX

HUVEPHARMA EOOD 61977/0710 61977/RV0318M


PTY LTD

62888/62023 62888/RV0318N

64657 TYLODOX 250 G

MICROGRANULATE

FEED ADDITIV

DOX-AL AUSTRALIA

PTY LTD

64657/0110 64657/RV0318O


PTY LTD

65360/101728 65360/RV0318P

67990 TYLOGRAN 250 BMP DOX-AL ITALIA S.P.A. 67990/106331 67990/RV0318Q

81769 TYLODOX 100G DOX-AL AUSTRALIA

PTY LTD

81769/104023 81769/RV0318R

BRIEF STATEMENT OF REASONS

Decision to affirm the registration of tylosin products and the approval of associated labels

The APVMA was not satisfied that the products, specified in Table 1 above, would meet the safety criteria for the purposes

of s 34(1)(a) of the Agvet Code when used according to the previously approved instructions (as listed in Column 4 of

Table 1).

However, the APVMA was satisfied for the purposes of s 34A(1)(b) that the relevant particulars of product registrations

and label approvals (namely, removal of instructions for use to stimulate growth and improve feed efficiency and addition

of a restraint statement) were capable of being varied in such a way as to allow the APVMA to be satisfied. Having so

varied those particulars, the registration and label approval of the products specified in Table 1 above were affirmed.

SUPPLY OF PRODUCTS BEARING PREVIOUSLY APPROVED LABELS

As the relevant particulars of tylosin products have been varied, it is more likely than not that there are products which

have left the custody of the manufacturer bearing labels which were the approved label (that is, the labels stated the

relevant particulars that were required to be stated on the label prior to the decisions of 29 March 2018), but which are now

unapproved labels.

The APVMA has determined, in accordance with s 81(3)(b) of the Agvet Code, that a one year period from the date of this

decision shall apply for the continued supply and use of registered products bearing the earlier approved labels as specified

in Column 4 of Table 1. During this time, products may continue to be used according to the earlier approved label

instructions. After that period all product that is supplied should bear the varied approved label.




APVMA CONTACT


Chemical Review


PO Box 6182

SYMONSTON ACT 2609

Phone: +61 2 6210 4749

Fax: +61 2 6210 4773 Email: [email protected]



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 2018 (No. 4).

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 Federal Register of Legislation website www.legislation.gov.au or the links

above.

For further information please contact:

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.legislation.gov.au/

https://edrms/id:A147213/document/versions/[email protected]


Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code

Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code

In the previous notice on page 41 of APVMA Gazette No. 7, the APVMA gazetted amendments which it has approved to

vary maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out

as in the APVMA’s MRL Standard.

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 2018

(No. 4)) to MRLs into Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code.

MRLs contained in Schedule 20 provide the limits for residues of agricultural and veterinary chemicals that may

legitimately occur in foods. By this means, Schedule 20 permits the sale of treated foods and protects public health and

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

The APVMA and Food Standards Australia New Zealand (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 Australian Government and the New Zealand Government 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.

FSANZ will make a Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO).

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

notice, below the details of the proposed amendment.

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

with the proposal, it will further notify any variations it makes to Schedule 20 in the APVMA Gazette. The variations will

take effect as from the date of that subsequent notice.



PROPOSED VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE

(10 April 2018)

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

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

To commence: on gazettal of variation

[1] The table to section S20–3 in Schedule 20 is varied by

[1.1] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order

Agvet chemical: Acetamiprid

Permitted residue—commodities of plant origin: Acetamiprid

Permitted residue—commodities of animal origin: Sum of acetamiprid and N-demethyl acetamiprid ((E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyanoacetamidine), expressed as acetamiprid

Cherries 2

Plums (including prunes) 0.5

Stone fruits [except cherries; plums] 0.5

Agvet chemical: Emamectin

Permitted residue: Sum of emamectin B1a and emamectin B1b

Blueberries T0.07

Agvet chemical: Metalaxyl

Permitted residue: Metalaxyl

Basil T5

Basil, dry T30

Agvet chemical: Novaluron

Permitted residue: Novaluron

Stone fruits [except cherries] 0.5

Agvet chemical: Pendimethalin

Permitted residue: Pendimethalin

All other foods except animal food commodities

0.02

Agvet chemical: Penflufen

Permitted residue: Penflufen

Lupin (dry) T*0.01

Soya bean (dry) T*0.01



Agvet chemical: Prochloraz

Permitted residue: Sum of prochloraz and its metabolites containing the 2,4,6-trichlorophenol moiety, expressed as prochloraz

All other foods except animal food commodities

0.1

Cherimoya T1

Ilama T1

Soursop T1

Sugar apple T1

[1.2] omitting for each of the following chemicals, the maximum residue limit for the food and substituting

Agvet chemical: Pendimethalin

Permitted residue: Pendimethalin

Legume vegetables T0.2

Agvet chemical: Prochloraz

Permitted residue: Sum of prochloraz and its metabolites containing the 2,4,6-trichlorophenol moiety, expressed as prochloraz

Custard apple T1



INVITATION FOR SUBMISSIONS

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

proposal to vary Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code. Submissions

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

are associated with the occurrence of the proposed residues in foods. Comments received outside these grounds will not

be considered by the APVMA. Claims made in submissions should be supported wherever possible by referencing or

including relevant studies, research findings, trials, surveys etc. Technical information should be in sufficient detail to

allow independent scientific assessment.

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

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

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

Schedule 20’ and quote the correct amendment number.

DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (AEST) 8 May 2018

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 4837

Fax: +61 2 6210 4840



APVMA Gazette No. 7, 10 April 2018 · Product name: Loveland Products Radiate Growth Promotant...

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Transcript of APVMA Gazette No. 7, 10 April 2018 · Product name: Loveland Products Radiate Growth Promotant...