APVMA Gazette No. 24, 3 December 2019 · Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 3 December 2019 Agricultural and Veterinary Chemicals Code Act 1994 6 Agricultural

Gazette

Agricultural and

Veterinary Chemicals

No. APVMA 24, Tuesday, 3 December 2019

Published by the Australian Pesticides and Veterinary Medicines Authority

The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The

Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be

published in the Gazette containing details of the registration of agricultural and veterinary chemical products

and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code

and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet

Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.

ISSN 1837-7629

© Commonwealth of Australia 2019

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:

Assistant Director, Communications

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Sydney, NSW, 2001

Email: [email protected]

Website: apvma.gov.au

GENERAL INFORMATION

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

the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as requi red

by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material

issued by the APVMA.

Pursuant to section 8J(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications

made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

The APVMA Gazette is published in electronic format only and is available from the APVMA website.

If you would like to subscribe to receive email notification when a new edition is published, please complete the subscription

form.

APVMA CONTACTS

For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6770 2300.

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

https://apvma.us2.list-manage.com/subscribe?u=f09f7f9ed2a2867a19b99e2e4&id=a025640240

https://apvma.us2.list-manage.com/subscribe?u=f09f7f9ed2a2867a19b99e2e4&id=a025640240

Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 3 December 2019 Agricultural and Veterinary Chemicals Code Act 1994 3

CONTENTS

Agricultural Chemical Products and Approved Labels..................................................................................................... 4

Veterinary Chemical Products and Approved Labels .................................................................................................... 16

Approved Active Constituents ....................................................................................................................................... 23

Variations to Schedule 20 of the Australia New Zealand Food Standards Code ........................................................... 28


Agricultural Chemical Products and Approved Labels


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

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

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

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

1. AGRICULTURAL PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS

Application no.: 115720

Product name: Luximax Herbicide

Active constituent/s: 750 g/L cinmethylin

Applicant name: BASF Australia Ltd

Applicant ACN: 008 437 867

Summary of use: For the pre-emergence control of annual ryegrass (Lolium rigidum) and suppression of certain grass weeds in wheat (not durum wheat).

Date of registration: 15 November 2019

Product registration no.: 86413

Label approval no.: 86413/115720

2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Apparent Pelargonic 525 Herbicide

Active constituent/s: 525 g/L nonanoic acid

Applicant name: Apparent Pty Ltd


Summary of use: For non-selective control of seedling and young broadleaf and grass weeds; for suppression of established weeds and perennial species and for control of moss and algae





Product name: Gibbraltar Growth Regulator

Active constituent/s: 100 g/L gibberellic acid

Applicant name: Australian Adjuvants Pty Ltd


Summary of use: For stimulation of winter growth in pasture





Product name: Apparent Disturb 875 WG Herbicide

Active constituent/s: 875 g/kg terbuthylazine

Applicant name: Apparent Pty Ltd


Summary of use: For the control of weeds in sorghum and triazine tolerant canola







Product name: Podium Pre-emergent Herbicide

Active constituent/s: 10 g/kg pendimethalin, 7.5 g/kg dimethenamid-p



Summary of use: For use as a pre-emergence herbicide in ornamental production, landscape and grounds maintenance, and other specified non-crop areas including warm season turf





Product name: Barmac Diuron 900 WG Herbicide

Active constituent/s: 900 g/kg diuron

Applicant name: Amgrow Pty Ltd


Summary of use: For selective weed control in the situations as per the directions for use table





Product name: PestXpert DIY Pest Control Like a Professional Total Moth Control

Active constituent/s: 100 g/kg metofluthrin

Applicant name: Sumitomo Chemical Australia Pty Limited


Summary of use: For control of clothes and pantry moths





Product name: Spalding MCPA 500 Selective Herbicide

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

Applicant name: Spalding Holdings Pty Ltd


Summary of use: For the selective control of broad leaf weeds in cereals, linseed, pastures, sugarcane and turf





Product name: Titan Dicamba + MCPA Selective Herbicide

Active constituent/s: 340 g/L MCPA present as the dimethylamine salt, 80 g/L dicamba present as the dimethylamine salt

Applicant name: Titan Ag Pty Ltd


Summary of use: For the control of certain broadleaf weeds in winter cereals, pastures, turf and non-crop areas as per directions







Product name: Di-Bak G Herbicide

Active constituent/s: 700 g/kg glyphosate present as the mono-ammonium salt

Applicant name: Bioherbicides Australia Pty Ltd


Summary of use: For the control of tree weeds and unwanted tree plants in forestry, pasture, commercial, industrial and public service areas





Product name: Falgro 100 OD Plant Growth Regulator

Active constituent/s: 100 g/L gibberellic acid

Applicant name: Fine Agrochemicals Limited

Applicant ACN: N/A

Summary of use: For foliar spray application to promote desirable harvest effects and to stimulate production of winter-dormant grass-dominant pastures for high intensity grazing





Product name: Intercept 8500 Tin Free Linear Polishing Polymer Antifouling

Active constituent/s: 821 g/L copper present as cuprous oxide, 63 g/L copper pyrithione

Applicant name: Akzo Nobel Pty Limited


Summary of use: For control of marine growth below the waterline on vessels





Product name: Agritrading Terbuzyne 750 WG Herbicide

Active constituent/s: 750 g/kg terbuthylazine

Applicant name: Agritrading Pty Limited


Summary of use: For the control of weeds in chickpeas, faba beans, fallows, field peas, lentils, lupins, sorghum and triazine-tolerant canola





Product name: eFume Fumigant

Active constituent/s: 166.7 g/kg ethyl formate

Applicant name: Draslovka Services Private Limited

Applicant ACN: 43 609 536 763

Summary of use: For the control of certain insect pests in stored cereal grains, oilseeds, grain storage premises and equipment and horticultural produce pests







Product name: Barmac Atrazine 900 WG Herbicide

Active constituent/s: 900 g/kg atrazine



Summary of use: For selective annual grass and broadleaf weed control as per the directions for use table.





Product name: Titan Activ8 Surfactant

Active constituent/s: 870 g/L non-ionic surfactants



Summary of use: For use as a wetter/surfactant with agricultural chemicals





Product name: Pacific S-Metolachlor 960 EC Herbicide

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

Applicant name: Pacific Agriscience Pty Ltd


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





Product name: Vacsol Azure C RTU Timber Preservative

Active constituent/s: 4.5 g/L propiconazole, 4.5 g/L tebuconazole, 3.2 g/L permethrin (25:75)

Applicant name: Arch Wood Protection (Aust) Pty Limited


Summary of use: For the commercial treatment of timber against attack by borers, termites and fungi in above-ground situations





Product name: Redox Sodium Hypochlorite 12.5% Liquid Pool Chlorine Solution

Active constituent/s: 125 g/L available chlorine (Cl) present as sodium hypochlorite

Applicant name: Redox Pty Ltd


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







Product name: Barmac Diquat 200 Herbicide

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



Summary of use: For the control of a wide range of broadleaf weeds. For application through aircraft and ground equipment





Product name: Barmac Atrazine Flowable 500 SC Herbicide

Active constituent/s: 500 g/L atrazine



Summary of use: For use as a pre-emergence and post-emergence herbicide for the control of annual grasses and broadleaf weeds in a range of crops and Pinus radiata plantations and for use in triazine tolerant canola





Product name: Vacsol Azure RTU LO Timber Preservative









Product name: Vacsol Azure F RTU Timber Preservative









Product name: Virkill GQ Disinfectant

Active constituent/s: 150 g/L glutaraldehyde, 100 g/L quaternary ammonium compound

Applicant name: Abbey Laboratories Pty Ltd


Summary of use: For sanitizing poultry sheds, animal pens and farming equipment







Product name: Sullivans Mosquito Band

Active constituent/s: 0.75 g/band citronella oil

Applicant name: M.T. Sullivan & Co Pty Ltd


Summary of use: For helping to keep mosquitoes and insects away





Product name: Eurochem Dungeon 700 WG Fungicide

Active constituent/s: 700 g/kg dithianon

Applicant name: Eurochem Pty Ltd


Summary of use: For the control of downy mildew and blackspot in grapevines





Product name: Eurochem Presertex Fungicide

Active constituent/s: 500 g/L thiabendazole

Applicant name: Eurochem Pty Ltd


Summary of use: For the control of dry rot, gangrene and silver scurf of potato tubers; specific rots and moulds of fruit and fungal diseases of bulbs and corms





Product name: No Mosquitoes Professional Mosquito Control Biting Midge & Mosquito Barrier

Active constituent/s: 100 g/L bifenthrin

Applicant name: Australian Outdoor Lifestyle Pty Ltd


Summary of use: For control of adult mosquitoes and midges





Product name: Gro-sure Fenamiphos 400 EC Nematicide and Insecticide

Active constituent/s: 400 g/L fenamiphos

Applicant name: Agritrading Pty Limited


Summary of use: For the control of nematodes on aloe vera planting material and banana planting material







Product name: Barmac Tri-Max 480 Herbicide

Active constituent/s: 480 g/L trifluralin



Summary of use: For the control of annual grasses and certain broadleaf weeds in certain horticultural and agricultural crops





Product name: Para’Kito Mosquito Repellent Spray

Active constituent/s: 217 g/L oil of lemon eucalyptus (hydrated, cyclized)

Applicant name: Evergreen Land Limited

Applicant ACN: N/A

Summary of use: Personal repellent against mosquitoes and house flies





Product name: Barmac Dicamba 500 Selective Herbicide

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



Summary of use: For the control of certain broadleaf weeds in winter cereals, pastures, conservation tillage, sugar cane, turf, rice, grain sorghum and non-crop areas





Product name: Pestphos Fumigation Tablets

Active constituent/s: 330 g/kg phosphine (PH3) present as aluminium phosphide

Applicant name: Intech Organics Australia Pty Limited


Summary of use: For control of insect pests of stored products in specified situations





Product name: AC Joust 750 WG Herbicide

Active constituent/s: 750 g/kg sulfosulfuron

Applicant name: Axichem Pty Ltd


Summary of use: For the control of certain weeds in wheat and triticale







Product name: Pacific Azoxystrobin 250 SC Fungicide

Active constituent/s: 250 g/L azoxystrobin

Applicant name: Pacific Agriscience Pty Ltd


Summary of use: For the control of various diseases of grapes, potatoes, tomatoes, cucurbits, avocados, mangoes, passionfruit and poppies





Product name: Cadence Herbicide

Active constituent/s: 700 g/kg dicamba present as the sodium salt

Applicant name: Syngenta Australia Pty Ltd


Summary of use: For control of certain broadleaf weeds in winter cereals, pastures, conservation tillage, sugarcane, rice, turf, grain sorghum and non-crop areas





Product name: Asterik 600 EC Herbicide

Active constituent/s: 600 g/L triclopyr present as the butoxyethyl ester

Applicant name: Hemani Industries Limited

Applicant ACN: N/A

Summary of use: For the control of various woody and broadleaf weeds





Product name: Task 500 EC Insecticide

Active constituent/s: 500 g/L chlorpyifos

Applicant name: Hemani Industries Limited

Applicant ACN: N/A

Summary of use: For the control of a wide range of insect pests on fruit, vegetables, oilseeds, cotton, cereals, pasture, turf farms and other situations





Product name: Intervention Veterinary Disinfectant Cleaner

Active constituent/s: 44.03 g/L hydrogen peroxide

Applicant name: Diversey Australia Pty Limited


Summary of use: For use as a disinfectant in veterinary clinics, animal hospitals and animal housing






3. VARIATIONS OF REGISTRATION


Product name: Transform Isoclast active Insecticide

Active constituent/s: 240 g/L sulfoxaflor

Applicant name: Dow Agrosciences Australia Limited


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘Transform Insecticide’ to ‘Transform Isoclast active Insecticide’

Date of variation: 25 October 2019




Product name: Imtrade Permeshield 500 Residual Insecticide

Active constituent/s: 500 g/L permethrin (25:75 cis:trans)

Applicant name: Imtrade Australia Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘Chemag Permeshield 500 Residual Insecticide’ to ‘Imtrade Permeshield 500 Residual Insecticide’





Product name: Conquest Rangelan 200 Herbicide

Active constituent/s: 200 g/kg tebuthiuron

Applicant name: Conquest Crop Protection Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘Conquest Treeminator 200 Herbicide’ to ‘Conquest Rangelan 200 Herbicide’





Product name: Earthcore Glyphosate Weed Killer

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

Applicant name: Mitre 10 Australia Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘Gard & Grow Glyphosate Weed Killer’ to ‘Earthcore Glyphosate Weed Killer’

Date of variation: 1 November 2019






Product name: Earthcore Weeding and Feeding

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

Applicant name: Mitre 10 Australia Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘Gard & Grow Hose On Weeding And Feeding’ to ‘Earthcore Weeding and Feeding’





Product name: Rexade Arylex active Herbicide

Active constituent/s: 318.6 g/kg cloquintocet, 150 g/kg pyroxsulam, 50 g/kg halauxifen as the methyl ester

Applicant name: Dow Agrosciences Australia Limited


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘Rexade Herbicide’ to ‘Rexade Arylex active Herbicide’





Product name: Conquest Bayonet Flex 500 In-Furrow Fungicide

Active constituent/s: 500 g/L flutriafol



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘Conquest Bayonet Flexi 500 Fungicide’ to ‘Conquest Bayonet Flex 500 In-Furrow Fungicide’





Product name: Yates Home Pest Ant & Nest Killer Gel Bait

Active constituent/s: 0.5 g/kg indoxacarb (S:R 3:1)



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘Yates Home Pest Ant & Nest Kill Gel Bait’ to ‘Yates Home Pest Ant & Nest Killer Gel Bait’





Product name: Nobility Systemic Fungicide

Active constituent/s: 800 g/kg fosetyl-aluminium

Applicant name: Crop Culture Pty Ltd


Summary of variation: To amend expression of the level of active material from '800 g/kg fosetyl present as the aluminium salt' to '800 g/kg fosetyl-aluminium'







Product name: Pentamox Mineralised Oral Drench For Sheep

Active constituent/s: 2.1 g/L copper as disodium copper EDTA, 2.1 g/L copper as disodium copper EDTA, 1.0 g/L iodine as ethylenediamine dihydroiodide, 1.0 g/L moxidectin, 0.6 g/L zinc as disodium zinc EDTA, 0.5 g/L selenium as sodium selenate, 0.2 g/L cobalt as disodium cobalt EDTA

Applicant name: Jurox Pty Limited


Summary of variation: To amend contraindications and general directions section





Product name: Redox Metham Sodium Soil Fumigant

Active constituent/s: 423 g/L metham present as sodium salt

Applicant name: Redox Pty Ltd


Summary of variation: To update product name, add pack sizes and vary particulars of the label





Product name: Mesurol Snail and Slug Bait

Active constituent/s: 20 g/kg methiocarb (an anticholinesterase compound)

Applicant name: Bayer Cropscience Pty Ltd


Summary of variation: To update the wording of the label as per the chemical review outcomes of methiocarb and Mesurol Snail and Slug Bait as published by the AVPMA





Product name: Cruiser 350 FS Insecticide Seed Treatment

Active constituent/s: 350 g/L thiamethoxam



Summary of variation: To extend use to include control of Russian wheat aphid and wireworm in wheat and barley





Product name: Chaindrite Extra Strength Crawling Insect Spray

Active constituent/s: 2 g/kg cypermethrin, 1.4 g/kg imiprothrin

Applicant name: Sherwood Corporation (Thailand) Public Company Limited

Applicant ACN: N/A

Summary of variation: To add new pests







Product name: Genfarm Triclopyr 755EC Herbicide

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

Applicant name: Landmark Operations Limited


Summary of variation: Variation of label approval to remove knapsack and handheld use from the label





Product name: Conquest Racer 250 WG Selective Herbicide

Active constituent/s: 250 g/kg butroxydim



Summary of variation: Variation of registration and label approval to change the adjuvants and include a tank mix for the control of clethodim-tolerant annual rye grass weeds





Product name: Nufarm Digger Fungicide

Active constituent/s: 250 g/L difenoconazole

Applicant name: Nufarm Australia Limited


Summary of variation: To make a minor change to the formulation and to update the label constituent statements to include the scheduled excipient, polyethanoxy (15) tallow amine





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: Independents Own Canine Shield Palatable Allwormer Tablets For Medium Dogs

Active constituent/s: 50 mg/tablet praziquantel, 225 mg/tablet oxibendazole

Applicant name: The Hunter River Company Pty Limited


Summary of use: For the treatment and control of roundworm, hookworm, whipworm and tapeworm in medium dogs





Product name: Independents Own Canine Shield Palatable Allwormer Tablets For Large Dogs

Active constituent/s: 100 mg/tablet praziquantel, 450 mg/tablet oxibendazole

Applicant name: The Hunter River Company Pty Limited


Summary of use: For the treatment and control of roundworm, hookworm, whipworm and tapeworm in large dogs





Product name: Triumph (Fipronil Plus (S)-methoprene) For Cats

Active constituent/s: 120 g/L (S)-methoprene, 100 g/L fipronil

Applicant name: Shanghai Neway Animal Health Co Ltd

Applicant ACN: N/A

Summary of use: For the treatment and prevention of flea infestation (Ctenocephalides spp) and biting lice (Felicola subrostratus) on cats and kittens





Product name: Apex Clindamycin 75 Tablets

Active constituent/s: 75 mg/tablet clindamycin as clindamycin hydrochloride

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd


Summary of use: For treatment of dental infections, wounds, abscesses and osteomyelitis caused by bacteria susceptible to clindamycin in dogs and cats







Product name: Tilmix Injection For Cattle

Active constituent/s: 300 mg/mL tilmicosin as tilmicosin phosphate



Summary of use: For the treatment by subcutaneous injection only in cattle of Bovine Respiratory Disease (BRD) associated with Mannheimia (Pasteurella) haemolytica, Pasteurella multocida and other organisms susceptible to tilmicosin





Product name: Crusader Spot On For Cats Over 4 Kg

Active constituent/s: 100 g/L imidacloprid

Applicant name: Neove Pharma Australia Pty Limited


Summary of use: For the treatment and prevention of fleas (Ctenocephalides spp) on cats, kills larval stages of fleas and reduces the incidence of Flea Allergy Dermatitis





Product name: Crusader Spot On For Dogs 10 - 25 Kg




Summary of use: For the treatment and prevention of fleas (Ctenocephalides spp) on large dogs, kills larval stages of fleas and reduces the incidence of Flea Allergy Dermatitis. For the control of lice (Trichodectes canis, Linognathus setosus)





Product name: Crusader Spot On For Dogs 4 - 10 Kg




Summary of use: For the treatment and prevention of fleas (Ctenocephalides spp) on medium dogs, kills larval stages of fleas and reduces the incidence of Flea Allergy Dermatitis. For the control of lice (Trichodectes canis, Linognathus setosus)







Product name: Crusader Spot On for Puppies & Small Dogs Up To 4 kg




Summary of use: For the treatment and prevention of fleas (Ctenocephalides spp) on puppies and small dogs up to 4kg, kills larval stages of fleas and reduces the incidence of Flea Allergy Dermatitis. For the control of lice (Trichodectes canis, Linognathus setosus)





Product name: Meloxidolor 5 MG/ML Solution For Injection For Dogs And Cats

Active constituent/s: 5 mg/mL meloxicam

Applicant name: Le Vet Beheer BV

Applicant ACN: N/A

Summary of use: For alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders and reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery in dogs, and for reduction of pain after surgery and management of febrile conditions in conjunction with appropriate antibiotics in cats





Product name: Triumph (Fipronil Plus (S)-Methoprene) For Small Dogs

Active constituent/s: 100 g/L fipronil, 90 g/L (S)-methoprene


Applicant ACN: N/A

Summary of use: For the treatment and prevention of flea infestation (Ctenocephalides spp), control of brown dog ticks (Rhipicephalus sanguineus), paralysis ticks (Ixodes holocyclus) and biting lice (Trichodectes canis) on dogs and puppies. Also aids in the control of sarcoptic mange (Sarcoptes scabiei var canis) in dogs





Product name: Triumph (Fipronil Plus (S)-Methoprene) For Medium Dogs



Applicant ACN: N/A








Product name: Triumph (Fipronil Plus (S)-Methoprene) For Large Dogs



Applicant ACN: N/A






Product name: Crusader Spot On For Dogs Over 25 Kg




Summary of use: For the treatment and prevention of fleas (Ctenocephalides spp) on large dogs, kills larval stages of fleas and reduces the incidence of Flea Allergy Dermatitis. For the control of lice (Trichodectes canis, Linognathus setosus)





Product name: Triumph (Fipronil Plus (S)-Methoprene) For Extra Large Dogs



Applicant ACN: N/A






Product name: Pastoral Ag Doramectin Injection For Cattle And Pigs

Active constituent/s: 10 mg/mL doramectin



Summary of use: For the treatment and control of internal and external parasites of cattle and pigs







Product name: Forceris Injection

Active constituent/s: 133.4 mg/mL iron, 30 mg/mL toltrazuril

Applicant name: CEVA Animal Health Pty Ltd


Summary of use: For the prevention of iron deficiency anaemia, reduction in oocyst excretion and prevention of clinical signs of coccidiosis in farms with a confirmed history of coccidiosis caused by Cystoisospora suis





Product name: Tetramax 100 Injection

Active constituent/s: 96 mg/mL oxytetracycline as oxytetracycline hydrochloride



Summary of use: For use in cattle, sheep and pigs as an injectable antibiotic




2. VARIATIONS OF REGISTRATION


Product name: Equimate Oral Progestagen For Horses

Active constituent/s: 2.2 mg/mL altrenogest



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘Sowmate Oral Progestagen For Horses’ to ‘Equimate Oral Progestagen For Horses’





Product name: Vet's Choice Ivermectin Pour On For Cattle

Active constituent/s: 10 mg/mL ivermectin

Applicant name: Bayer Australia Ltd (Animal Health)


Summary of variation: To update active solvents, first aid instructions, safety directions, trade advice and environmental statements







Product name: Taktic EC Acaricidal Spray For Cattle And Pigs

Active constituent/s: 125 g/L amitraz

Applicant name: Intervet Australia Pty Limited


Summary of variation: To update the label of the product to include the APVMA approved ESI of zero (0) days





Product name: Moxxi Pour-On For Cattle And Red Deer

Active constituent/s: 5 g/L moxidectin



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘Moxi Pour-On For Cattle And Red Deer’ to ‘Moxxi Pour-On For Cattle And Red Deer’





Product name: Seresto For Kittens and Cats Fleas and Tick Collar

Active constituent/s: 100 mg/g imidacloprid, 45 mg/g flumethrin



Summary of variation: Extending the label claims to include the statement ‘Repels and controls paralysis ticks (Ixodes holocyclus) for 8 months’ and to change the product name





Product name: Ceprotect DC

Active constituent/s: 89.9 g/kg cephalonium as cephalonium dihydrate

Applicant name: Norbrook Laboratories Australia Pty Limited


Summary of variation: To amend label claims and other relevant sections to align with the vet labelling code





Product name: Dryclox Xtra Dry Cow Intramammary Suspension

Active constituent/s: 600 mg/syringe cloxacillin as the benzathine salt, 300 mg/syringe ampicillin as the trihydrate



Summary of variation: Product name changed to ‘Dryclox Xtra Dry Cow Intramammary Suspension’







Product name: Rhinogard Bovine Herpesvirus 1 Live Intranasal Vaccine For Feedlot Cattle

Active constituent/s: ≥ 10^ 4 CCID50/dose (2 mL) BHV1

Applicant name: Zoetis Australia Pty Ltd


Summary of variation: To vary the label approval to add additional pack sizes and update the Dosage and Administration, WHP and ESI sections and align the label with the Vet Labelling Code





Product name: Cydectin Injection For Cattle

Active constituent/s: 10 g/L moxidectin

Applicant name: Virbac (Australia) Pty Ltd


Summary of variation: To include an in-use shelf life




3. VARIATION OF LABEL APPROVAL


Product name: Tridectin 3-Way Oral Drench For Sheep

Active constituent/s: 40 g/L levamisole hydrochloride, 25 g/L albendazole, 1 g/L moxidectin



Summary of variation: To update label claims





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: adrenaline acid tartrate

Applicant name: Animal Ethics Pty Ltd


Summary of use: For use in veterinary chemical products

Date of approval: 11 November 2019

Approval no.: 87921


Active constituent/s: cinmethylin



Summary of use: For use in agricultural chemical products


Approval no.: 86412


Active constituent/s: methadone hydrochloride

Applicant name: Ferrari Animal Health Pty Ltd




Approval no.: 87919


Active constituent/s: benzylpenicillin procaine

Applicant name: Intervet Australia Pty Limited




Approval no.: 88013


Active constituent/s: ceftiofur sodium

Applicant name: Randlab Australia Pty Ltd




Approval no.: 88036




Active constituent/s: metribuzin

Applicant name: Aimco KR Australia Pty Ltd




Approval no.: 87636


Active constituent/s: pyrantel embonate

Applicant name: Randlab Australia Pty Ltd




Approval no.: 87946


Active constituent/s: copper disodium edetate

Applicant name: Vetpharm Pty Limited




Approval no.: 87992


Active constituent/s: disodium manganese EDTA





Approval no.: 87996


Active constituent/s: disodium zinc EDTA





Approval no.: 88024


Active constituent/s: bupivacaine hydrochloride





Approval no.: 87922




Active constituent/s: ioxynil octanoate

Applicant name: Stefes GmbH

Applicant ACN: N/A



Approval no.: 88020


Active constituent/s: boscalid



Summary of use: For use in Agricultural chemical products


Approval no.: 87977


Active constituent/s: chondroitin sulphate sodium

Applicant name: Blackmores Limited




Approval no.: 88047


Active constituent/s: MCPA





Approval no.: 87444


Active constituent/s: lignocaine hydrochloride





Approval no.: 87923


Active constituent/s: spirotetramat

Applicant name: Jiangsu Yunfan Chemical Co Ltd

Applicant ACN: N/A



Approval no.: 88109




Active constituent/s: plasmid DNA, pINGhT

Applicant name: Boehringer Ingelheim Animal Health Australia Pty Ltd




Approval no.: 82142


Active constituent/s: ioxynil octanoate





Approval no.: 87611


Active constituent/s: glyphosate

Applicant name: Fufarm Co Pty Ltd




Approval no.: 87893


Active constituent/s: estradiol benzoate

Applicant name: Zoetis Australia Pty Ltd




Approval no.: 88136

2. VARIATIONS OF ACTIVE CONSTITUENT


Active constituent/s: triclabendazole

Applicant name: Elanco Australasia Pty Ltd


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


Approval no.: 82176


Active constituent/s: enrofloxacin

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd




Approval no.: 82082




Active constituent/s: manganese carbonate



Summary of use: Variation of relevant particulars of an approved active constituent


Approval no.: 83580


Active constituent/s: nicarbazin

Applicant name: Phibro Animal Health Pty Limited


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


Approval no.: 82391


Active constituent/s: naphthalophos





Approval no.: 83740


Variations to Schedule 20 of the Australia New Zealand Food Standards Code


The APVMA has previously gazetted particular amendments which it had made to the APVMA MRL Standard and which

have been proposed as variations to maximum residue limits (MRLs) for substances contained in agricultural and

veterinary chemical products as set out as in Schedule 20–Maximum Residue Limits of the Australia New Zealand Food

Standards Code. This notice pertains to proposal (No. 1) gazetted on 10 September 2019 (No. APVMA 18).

Submissions have been sought on these proposals and the APVMA has written separately to each person or

organisation that made a submission. All matters raised in the submissions have been resolved.

Under subsection 82(1) of the Food Standards Australia New Zealand Act 1991, the APVMA has, by legislative

instrument, incorporated these variations to MRLs into Schedule 20. A copy of the Amendment Instrument (No. APVMA

7, 2019) accompanies this notice. For a complete and up-to-date version of Schedule 20, including these amendments

together with their Explanatory Statement, please refer to the Federal Register of Legislation available on the Legislation

website at www.legislation.gov.au

Based on dietary exposure assessments and current health standards, the APVMA and Food Standards Australia and

New Zealand (FSANZ) are satisfied that these MRLs are not harmful to public health. 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 by minimising residues in foods

consistent with the effective control of pests and diseases.

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 made Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO) in relation to these

variations and no comment was received in response to that notice.

A copy of these variations have been given to FSANZ.

The variations take effect as from the date of this notice.

This notice is published in accordance with subsection 82(7) of the Food Standards Australia New Zealand Act 1991.

For further information please contact:

MRL Contact Officer

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

SYDNEY NSW 2001

Phone: +61 2 6770 2383

Email: [email protected]

http://www.legislation.gov.au/

mailto:[email protected]

Australia New Zealand Food Standards Code —

Schedule 20 — Maximum residue limits Variation Instrument No. APVMA 7, 2019

I, Jason Lutze, delegate of the Australian Pesticides and Veterinary Medicines

Authority, acting in accordance with my powers under subsection 11(1) of the

Agricultural and Veterinary Chemicals (Administration) Act 1992, make this

instrument for the purposes of subsection 82(1) of the Food Standards Australia New

Zealand Act 1991.

Jason Lutze

Delegate of the Chief Executive Officer of the Australian Pesticides and Veterinary

Medicines Authority

Dated this Twenty Seventh day of November 2019



Part 1 Preliminary

1 Name of instrument

This instrument is the Australia New Zealand Food Standards Code — Schedule 20 Maximum residue limits Variation Instrument No. APVMA 7, 2019.

2 Commencement

In accordance with subsection 82(8) of the Food Standards Australia New Zealand Act 1991, this instrument commences on the day it is published in the Gazette.

Note: A copy of the variations made by the Amendment Instrument was published in the

Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette.

3 Object

The object of this instrument is for the APVMA to make variations to Schedule 20 Maximum residue limits in the Australia New Zealand Food Standards Code to include or change maximum residue limits pertaining to agricultural and veterinary chemical products.

4 Interpretation

In this instrument: —

APVMA means the Australian Pesticides and Veterinary Medicines Authority established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; and

Principal Instrument means Schedule 20 Maximum residue limits in the Australia New Zealand Food Standard Code as defined in Section 4 of the Food Standards Australia New Zealand Act 1991 being the Code published in Gazette No. P 27 on 27 August 1987 together with any amendments of the standards in that Code. Schedule 20 was published in the Food Standards Gazette FSC 96 on Thursday 10 April 2015 and was registered as a legislative instrument on 1 April 2015 (F2015L00468).

Part 2 Variations to Schedule 20— Maximum Residue Limits

5 Variations to Schedule 20

The Schedule to this instrument sets out the variations made to the Principal Instrument by this instrument.



Schedule

Variations to Schedule 20 – Maximum residue limits

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

[1.1] omitting from each of the following chemicals, the foods and associated MRLs

Agvet chemical: Azoxystrobin

Permitted residue: Azoxystrobin

Tree nuts [except almonds] 2

Agvet chemical: Difenoconazole

Permitted residue: Difenoconazole

Mizuna T5

Agvet chemical: Pyraclostrobin

Permitted residue: commodities of plant origin: Pyraclostrobin

Permitted residue—commodities of animal origin: Sum of pyraclostrobin and metabolites hydrolysed to 1-(4-chloro-phenyl)-1H-pyrazol-3-ol, expressed as pyraclostrobin

Olives T1

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

Agvet chemical: Afidopyropen

Permitted residue—commodities of plant origin: Afidopyropen

Permitted residue—commodities of animal origin: Afidopyropen and the carnitine conjugate of cyclopropanecarboxylic acid (M440I060), expressed as afidopyropen

All other foods except animal food commodities

0.02

Strawberry T0.1

Agvet chemical: Aminopyralid

Permitted residue: commodities of plant origin: Sum of aminopyralid and conjugates, expressed as Aminopyralid

Permitted residue—commodities of animal origin: Aminopyralid


0.02



Agvet chemical: Azoxystrobin

Permitted residue: Azoxystrobin

Macadamia nuts *0.01

Tree nuts [except almonds and macadamia nuts]

2

Agvet chemical: Benzovindiflupyr

Permitted residue: Benzovindiflupyr

Barley 0.2

Edible offal (mammalian) *0.01

Eggs *0.01

Meat (mammalian) [in the fat] *0.01

Milks *0.01

Poultry, edible offal of *0.01

Poultry meat [in the fat] *0.01

Wheat 0.01

Agvet chemical: Cypermethrin

Permitted residue: Cypermethrin, sum of isomers

Hempseed T0.1

Agvet chemical: Flumioxazin

Permitted residue: Flumioxazin

Garlic T*0.02

Agvet chemical: Halauxifen-methyl

Permitted residue: commodities of plant origin: Halauxifen-methyl

Permitted residue—commodities of animal origin: 4-Amino-3-chloro-6-(4-chloro-2-fluoro-3-hydroxyphenyl)-pyridine-2-carboxylic acid, expressed as halauxifen-methyl


0.01

Agvet chemical: Imazapyr

Permitted residue: Imazapyr


0.05

Agvet chemical: Metalaxyl

Permitted residue: Metalaxyl

Hazelnuts T*0.05



Agvet chemical: Napropamide

Permitted residue: Napropamide

Brassica (cole or cabbage) vegetables, head cabbages, flowerhead brassicas

T*0.1

Agvet chemical: Pyraclostrobin

Permitted residue: commodities of plant origin: Pyraclostrobin

Permitted residue—commodities of animal origin: Sum of pyraclostrobin and metabolites hydrolysed to 1-(4-chloro-phenyl)-1H-pyrazol-3-ol, expressed as pyraclostrobin

Table olives T0.3

Olives for oil production T0.3

Olive oil, crude T1

Agvet chemical: Pyrethrins

Permitted residue: Sum of pyrethrins i and ii, Cinerinsi i and ii and jasmolins i and ii, determined after calibration by means of the International Pyrethrum Standard

Fennel, leaf 1

Olive oil, crude T3

Agvet chemical: Pyriproxyfen

Permitted residue: Pyriproxyfen

Avocado 0.05

Macadamia nuts *0.01

Agvet chemical: Quizalofop-ethyl

Permitted residue: Sum of quizalofop-ethyl and quizalofop acid and other esters, expressed as quizalofop-ethyl

Hempseed T*0.02

Agvet chemical: Sethoxydim

Permitted residue: Sum of sethoxydim and metabolites containing the 5-(2-ethylthiopropyl) cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulfoxides and sulfones, expressed as sethoxydim

Hempseed T0.5

Safflower seed T0.5

Agvet chemical: Sulfoxaflor

Permitted residue: Sulfoxaflor

Longans T3



Agvet chemical: Terbuthylazine

Permitted residue: Terbuthylazine

Sugar cane *0.01

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

Agvet chemical: Abamectin

Permitted residue: Avermectin B1a

Custard apple T*0.01

Agvet chemical: Cyflufenamid

Permitted residue: Cyflufenamid

Strawberry 0.3

Agvet chemical: Difenoconazole

Permitted residue: Difenoconazole

Chard (silver beet) T5

Chicory leaves (green and red cultivars) T5

Endive T5

Spinach T5

Agvet chemical: Fludioxonil

Permitted residue—commodities of animal origin: Sum of fludioxonil and oxidisable metabolites, expressed as fludioxonil

Permitted residue—commodities of plant origin: Fludioxonil

Pineapple T5

Agvet chemical: Imidacloprid

Permitted residue: Sum of imidacloprid and metabolites containing the 6-chloropyridinylmethylene moiety, expressed as imidacloprid

Hazelnuts T0.05

Documents

APVMA Gazette No. 24, 3 December 2019 · Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 3 December 2019 Agricultural and Veterinary Chemicals Code Act 1994 6 Agricultural