apvma gazette no. 16, 11 august 2020 · commonwealth of australia gazette no. apvma 16, tuesday, 11...

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Gazette Agricultural and Veterinary Chemicals No. APVMA 16, Tuesday, 11 August 2020 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

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Page 1: APVMA Gazette No. 16, 11 August 2020 · Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 5 Agricultural

Gazette

Agricultural and

Veterinary Chemicals

No. APVMA 16, Tuesday, 11 August 2020

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

Page 2: APVMA Gazette No. 16, 11 August 2020 · Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 5 Agricultural

© Commonwealth of Australia 2020

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.

Page 3: APVMA Gazette No. 16, 11 August 2020 · Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 5 Agricultural

Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 3

CONTENTS

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

Veterinary Chemical Products and Approved Labels .................................................................................................... 12

Approved Active Constituents ....................................................................................................................................... 16

New agricultural active constituent: Aclonifen ............................................................................................................... 18

Amendments to the APVMA MRL Standard .................................................................................................................. 20

Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code ................................................. 21

Variations to Schedule 20 of the Australia New Zealand Food Standards Code ........................................................... 26

Stop Supply: Carbine Chemical Pty Ltd (ACN 169 715 440) ......................................................................................... 34

Stop Supply: SJ Enterprises Pty Ltd (ACN 133 549 130) .............................................................................................. 35

Stop Supply: Katpet Pty Ltd (ACN 618 282 296) ........................................................................................................... 36

Stop Supply: Fluidra Group Australia Pty Ltd (ACN 002 641 965) ................................................................................ 37

Page 4: APVMA Gazette No. 16, 11 August 2020 · Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 5 Agricultural

Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 4

Agricultural Chemical Products and Approved Labels

Agricultural Chemical Products and Approved Labels

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

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

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

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

1. AGRICULTURAL PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS

Application no.: 118088

Product name: EPIVIO C Sorghum Seed Safener

Active constituent/s: 400 g/L metcamifen

Applicant name: Syngenta Australia Pty Ltd

Applicant ACN: 002 933 717

Summary of use: For application to sorghum seed as a seed treatment to protect it from the phytotoxic effects of S-metolachlor

Date of registration: 22 July 2020

Product registration no.: 87317

Label approval no.: 87317/118088

Application no.: 125162

Product name: Trio Chlorothalonil 720 SC Fungicide

Active constituent/s: 720 g/L chlorothalonil

Applicant name: CTS Chemicals Pty Ltd

Applicant ACN: 605 759 644

Summary of use: For the control of fungal diseases on almonds, bananas, cucurbits, grapes, ornamentals, peanuts, stone fruits, tobacco and vegetables

Date of registration: 27 July 2020

Product registration no.: 89527

Label approval no.: 89527/125162

2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Application no.: 125092

Product name: Relyon Difenoconazole 250 Fungicide

Active constituent/s: 250 g/L difenoconazole

Applicant name: Ruralco Holdings Limited

Applicant ACN: 009 660 879

Summary of use: For the control of target spot of potatoes and tomatoes, leaf blight of carrots, leaf spot diseases of bananas and husk spot on macadamias

Date of registration: 20 July 2020

Product registration no.: 89505

Label approval no.: 89505/125092

Application no.: 125090

Product name: Relyon Glyphix Hitech Herbicide

Active constituent/s: 500 g/L glyphosate present as the potassium salt

Applicant name: Ruralco Holdings Limited

Applicant ACN: 009 660 879

Summary of use: For the control of a wide range of annual and perennial weeds in a range of situations

Date of registration: 21 July 2020

Product registration no.: 89503

Label approval no.: 89503/125090

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 5

Agricultural Chemical Products and Approved Labels

Application no.: 125117

Product name: Trio Flutriafol 500 SC Fungicide

Active constituent/s: 500 g/L flutriafol

Applicant name: CTS Chemicals Pty Ltd

Applicant ACN: 605 759 644

Summary of use: For the control of certain fungal diseases on wheat, barley and canola when mixed with fertilisers

Date of registration: 21 July 2020

Product registration no.: 89515

Label approval no.: 89515/125117

Application no.: 125710

Product name: Farmalinx Swysh 400 EC Herbicide

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

Applicant name: Farmalinx Pty Ltd

Applicant ACN: 134 353 245

Summary of use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, millets, pastures, poppies, sorghum, sugar cane, sweet corn, winter cereals. Also for the control of woody weeds in agricultural non-crop areas, commercial and industrial areas, forests, pastures and rights-of-way

Date of registration: 21 July 2020

Product registration no.: 89664

Label approval no.: 89664/125710

Application no.: 125081

Product name: Kelpie Clopyr-d 750 Herbicide

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

Applicant name: Sinochem International Australia Pty Ltd

Applicant ACN: 160 164 616

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

Date of registration: 21 July 2020

Product registration no.: 89501

Label approval no.: 89501/125081

Application no.: 125130

Product name: Titan Captan 900 WG Fungicide

Active constituent/s: 900 g/kg captan

Applicant name: Titan Ag Pty Ltd

Applicant ACN: 122 081 574

Summary of use: For the control of certain diseases in almonds, a range of fruit crops, turf and ornamentals

Date of registration: 22 July 2020

Product registration no.: 89522

Label approval no.: 89522/125130

Application no.: 120421

Product name: Moth Insecticide Paper

Active constituent/s: 4.5 g/kg transfluthrin

Applicant name: Yanco Limited

Applicant ACN: N/A

Summary of use: For control of adult clothes moths, moth larvae and moth eggs

Date of registration: 24 July 2020

Product registration no.: 88149

Label approval no.: 88149/120421

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 6

Agricultural Chemical Products and Approved Labels

Application no.: 125108

Product name: Macspred Picloram Herbicide

Active constituent/s: 240 g/L picloram present as the potassium salt

Applicant name: Macspred Pty Ltd

Applicant ACN: 011 029 495

Summary of use: For the control of a wide range of annual, perennial, noxious and woody weeds in agricultural non -crop areas, commercial and industrial areas, pasture and rights of way

Date of registration: 24 July 2020

Product registration no.: 89511

Label approval no.: 89511/125108

Application no.: 124122

Product name: Eezi Pool All-In-One Stabilized Monthly Pool Care

Active constituent/s: 900 g/kg available chlorine (CI) present as trichloroisocyanuric acid, 180 g/kg zinc present as zinc sulphate monohydrate, 75 g/kg copper present as copper sulphate pentahydrate

Applicant name: Eezi Pool Australia Pty Ltd

Applicant ACN: 632 990 320

Summary of use: For control of algae, bacteria, viruses and protozoa in outdoor swimming pools

Date of registration: 24 July 2020

Product registration no.: 89246

Label approval no.: 89246/124122

Application no.: 122747

Product name: Bushman Naturals Personal Insect Repellent

Active constituent/s: 190 g/L oil of lemon eucalyptus (hydrated, cyclized)

Applicant name: Juno Limited

Applicant ACN: N/A

Summary of use: For use as a personal insect repellent

Date of registration: 27 July 2020

Product registration no.: 88889

Label approval no.: 88889/122747

Application no.: 125163

Product name: Trio Propyzamide 500 SC Herbicide

Active constituent/s: 500 g/L propyzamide

Applicant name: CTS Chemicals Pty Ltd

Applicant ACN: 605 759 644

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

Date of registration: 27 July 2020

Product registration no.: 89528

Label approval no.: 89528/125163

Application no.: 125201

Product name: Coromandel Fipronil 200 SC Insecticide

Active constituent/s: 200 g/L fipronil

Applicant name: Sabero Australia Pty Ltd

Applicant ACN: 087 313 059

Summary of use: For the control of various insect pests in asparagus, bananas, brassicas, cotton, forestry, ginger, wine grapevines, mushrooms, pasture, potatoes, sorghum, sugarcane and swede

Date of registration: 28 July 2020

Product registration no.: 89536

Label approval no.: 89536/125201

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 7

Agricultural Chemical Products and Approved Labels

Application no.: 125197

Product name: Magneto 750 Herbicide

Active constituent/s: 750g/kg metribuzin

Applicant name: Sunrise Crop Science Co Ltd

Applicant ACN: N/A

Summary of use: For selective weed control in cereals, pastures and other crops, including vegetables

Date of registration: 28 July 2020

Product registration no.: 89533

Label approval no.: 89533/125197

Application no.: 124590

Product name: Kelpie Halox-F 520 Herbicide

Active constituent/s: 520 g/L haloxyfop-p present as the haloxyfop-p-methyl ester

Applicant name: Sinochem International Australia Pty Ltd

Applicant ACN: 160 164 616

Summary of use: For the post-emergent control of a wide range of annual and perennial grass weeds in grain legume and oilseed crops, lucerne, medic and clover pasture and seed crops, forestry, bananas, citrus, grapes, pineapples, pome and stone fruit, pyrethrum, tropical fruit and nut crops

Date of registration: 29 July 2020

Product registration no.: 89391

Label approval no.: 89391/124590

Application no.: 119544

Product name: Campbell ecoFog-170 DPA Scald Inhibitor

Active constituent/s: 170 g/L diphenylamine

Applicant name: Colin Campbell (Chemicals) Pty Ltd

Applicant ACN: 000 045 590

Summary of use: For control of superficial scald in apples and pears

Date of registration: 29 July 2020

Product registration no.: 87844

Label approval no.: 87844/119544

Application no.: 126347

Product name: Pestrol Multi Insect Killer Spray

Active constituent/s: 16.1g/kg piperonyl butoxide, 3.5g/kg pyrethrins

Applicant name: Aaron Laboratories Pty Ltd

Applicant ACN: 004 856 848

Summary of use: For control of flying and crawling insects

Date of registration: 30 July 2020

Product registration no.: 89921

Label approval no.: 89921/126347

Application no.: 120850

Product name: Gravitate 707 Spray Adjuvant

Active constituent/s: 340 g/L vegetable oil ester, 142 g/L citric acid, 225 g/L soyal phospholipids

Applicant name: Victorian Chemical Company Pty Ltd

Applicant ACN: 004 188 863

Summary of use: For use with glyphosate and other herbicides

Date of registration: 30 July 2020

Product registration no.: 88317

Label approval no.: 88317/120850

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 8

Agricultural Chemical Products and Approved Labels

Application no.: 125877

Product name: Vitara 500 SL Herbicide

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

Applicant name: Tagros Chemicals India Private Limited

Applicant ACN: N/A

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

Date of registration: 30 July 2020

Product registration no.: 89715

Label approval no.: 89715/125877

Application no.: 122941

Product name: Choice Shotup Herbicide

Active constituent/s: 140 g/L fluroxypyr present as methylheptyl ester, 10 g/L aminopyralid present as the triisopropanolamine salt

Applicant name: Grow Choice Pty Ltd

Applicant ACN: 161 264 884

Summary of use: For the control of climbing buckwheat and other broadleaf weeds in winter cereals and fallow, and control of lantana and certain other pasture weeds

Date of registration: 31 July 2020

Product registration no.: 88924

Label approval no.: 88924/122941

Application no.: 120420

Product name: Yanco Moth Hanger

Active constituent/s: 4.5 g/kg transfluthrin

Applicant name: Yanco Limited

Applicant ACN: N/A

Summary of use: For the control of clothes moths in clothing storage situations

Date of registration: 31 July 2020

Product registration no.: 88148

Label approval no.: 88148/120420

3. VARIATIONS OF REGISTRATION

Application no.: 126329

Product name: Problad Fungicide

Active constituent/s: 250 g/L blad manufacturing concentrate

Applicant name: Cev S A

Applicant ACN: N/A

Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Problad Plus Fungicide’ to ‘Problad Fungicide’

Date of variation: 13 July 2020

Product registration no.: 70334

Label approval no.: 70334/126329

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 9

Agricultural Chemical Products and Approved Labels

Application no.: 126358

Product name: Isacop 500WP Fungicide

Active constituent/s: 500 g/kg copper present as copper oxychloride

Applicant name: Isagro Australia Pty Ltd

Applicant ACN: 066 736 114

Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Relyon Isacop 500WP Fungicide’ to ‘Isacop 500WP Fungicide’ and to remove the tobacco seed beds use

Date of variation: 15 July 2020

Product registration no.: 53597

Label approval no.: 53597/126358

Application no.: 126431

Product name: Kenso Agcare Radicle 600 FS Flowable Seed Dressing Insecticide

Active constituent/s: 600 g/L imidacloprid

Applicant name: Kenso Corporation (M) Sdn Bhd

Applicant ACN: N/A

Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Kenso Agcare Radicle 600 FS Flowable Seed Dressing’ to ‘Kenso Agcare Radicle 600 FS Flowable Seed Dressing Insecticide’ and to add 10L pack size and pack size range of 5L–1000L

Date of variation: 16 July 2020

Product registration no.: 62062

Label approval no.: 62062/126431

Application no.: 125102

Product name: Lazco Binkill Protector

Active constituent/s: 186 g/kg Dichlorvos

Applicant name: Lazco Investments Pty Ltd

Applicant ACN: 069 972 354

Summary of variation: To include smaller strip sizes and add use in fruit fly traps

Date of variation: 20 July 2020

Product registration no.: 67600

Label approval no.: 67600/125102

Application no.: 126455

Product name: Farmalinx Winx Herbicide

Active constituent/s: 100 g/kg iodosulfuron-methyl-sodium

Applicant name: Farmalinx Pty Ltd

Applicant ACN: 134 353 245

Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Farmalinx Iodosulfuron Herbicide’ to ‘Farmalinx Winx Herbicide’

Date of variation: 21 July 2020

Product registration no.: 88829

Label approval no.: 88829/126455

Application no.: 124163

Product name: Ezycrop Terbuthylazine 875WG Herbicide

Active constituent/s: 875 g/kg terbuthylazine

Applicant name: Ezycrop Pty Ltd

Applicant ACN: 156 476 827

Summary of variation: To add uses in chickpeas, faba beans, field peas, lupins, lentils and fallow

Date of variation: 24 July 2020

Product registration no.: 86510

Label approval no.: 86510/124163

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 10

Agricultural Chemical Products and Approved Labels

Application no.: 123254

Product name: Conquest Knockout Extreme Herbicide

Active constituent/s: 540 g/L glyphosate present as the potassium salt

Applicant name: Conquest Crop Protection Pty Ltd

Applicant ACN: 098 814 932

Summary of variation: To extend the use to include pre-harvest/cutting application as harvest aid for weed control in canola

Date of variation: 24 July 2020

Product registration no.: 85582

Label approval no.: 85582/123254

Application no.: 125133

Product name: Ozcrop 2,4-D Amine 625 Herbicide

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

Applicant name: Ozcrop Pty Ltd

Applicant ACN: 160 656 431

Summary of variation: To update the spray drift restraints and add additional weeds for wheat, barley, oats, triticale, cereal rye, pastures and non-agricultural settings

Date of variation: 24 July 2020

Product registration no.: 66321

Label approval no.: 66321/125133

Application no.: 125190

Product name: Trump Spray Oil

Active constituent/s: 830 g/L paraffinic oil

Applicant name: Victorian Chemical Company Pty Ltd

Applicant ACN: 004 188 863

Summary of variation: To include a re-entry period and amend the withholding period

Date of variation: 28 July 2020

Product registration no.: 59092

Label approval no.: 59092/125190

Application no.: 122101

Product name: Quadrant Herbicide

Active constituent/s: 250 g/L MCPA present as the ethyl hexyl ester, 240 g/L bromoxynil present as the octanoate, 20 g/L diflufenican, 10 g/L picolinafen

Applicant name: Adama Australia Pty Ltd

Applicant ACN: 050 328 973

Summary of variation: To include control of matricaria (globe chamomile) in cereals

Date of variation: 28 July 2020

Product registration no.: 85692

Label approval no.: 85692/122101

Application no.: 125260

Product name: Titan Imidacloprid 350 SC Insecticide

Active constituent/s: 350 g/L imidacloprid

Applicant name: Titan Ag Pty Ltd

Applicant ACN: 122 081 574

Summary of variation: To add uses for the control of insects on citrus, bananas, apples, potatoes and sugar cane/ratoon cane

Date of variation: 29 July 2020

Product registration no.: 86992

Label approval no.: 86992/125260

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 11

Agricultural Chemical Products and Approved Labels

Application no.: 123797

Product name: Higran Turf Miticide

Active constituent/s: 500 g/L diafenthiuron

Applicant name: Syngenta Australia Pty Ltd

Applicant ACN: 002 933 717

Summary of variation: To update precautions, and storage and disposal statements

Date of variation: 29 July 2020

Product registration no.: 68340

Label approval no.: 68340/123797

Application no.: 124945

Product name: Scholar Fungicide

Active constituent/s: 230 g/L fludioxonil

Applicant name: Syngenta Australia Pty Ltd

Applicant ACN: 002 933 717

Summary of variation: To add suppression of surface moulds and fungal rots in chestnuts

Date of variation: 30 July 2020

Product registration no.: 63391

Label approval no.: 63391/124945

Application no.: 124941

Product name: Relyon Glyphosate 540 K Herbicide

Active constituent/s: 540g/L glyphosate

Applicant name: Nutrien Ag Solutions Limited

Applicant ACN: 008 743 217

Summary of variation: To change the product name to ‘Relyon Glyphosate 540 K Herbicide’ from ‘Glyphix Max 540 Herbicide’

Date of variation: 31 July 2020

Product registration no.: 82560

Label approval no.: 82560/124941

4. VARIATION OF LABEL APPROVAL

Application no.: 125212

Product name: Rootx Pipeline Root Control

Active constituent/s: 5.5 g/kg dichlobenil

Applicant name: Nordkapp Investments Pty Ltd

Applicant ACN: 000 693 854

Summary of variation: To amend the label instructions for use with foam dispersal units

Date of variation: 29 July 2020

Product registration no.: 58791

Label approval no.: 58791/125212

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 12

Veterinary Chemical Products and Approved Labels

Veterinary Chemical Products and Approved Labels

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

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

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

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

1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Application no.: 123658

Product name: Teatready Premixed Teat Dip And Spray

Active constituent/s: 5 g/L available iodine

Applicant name: IWTS Group Pty Ltd

Applicant ACN: 152 692 969

Summary of use: For use as an aid in the control of mastitis in dairy cows

Date of registration: 20 July 2020

Product registration no.: 89117

Label approval no.: 89117/123658

Application no.: 125978

Product name: Purina Procare Medicated Dermprotect Shampoo For Dogs

Active constituent/s: 5 mg/mL triclosan, 4 mg/mL salicylic acid

Applicant name: Nestle Australia Ltd

Applicant ACN: 000 011 316

Summary of use: For use in dogs to assist in the relief of dermatoses, eczema and dry skin

Date of registration: 21 July 2020

Product registration no.: 89749

Label approval no.: 89749/125978

Application no.: 121396

Product name: Draxxin KP Plus Ketoprofen Injectable Solution For Cattle

Active constituent/s: 120 mg/mL ketoprofen, 100 mg/mL tulathromycin

Applicant name: Zoetis Australia Pty Ltd

Applicant ACN: 156 476 425

Summary of use: For the treatment of bovine respiratory disease and associated pyrexia in cattle

Date of registration: 24 July 2020

Product registration no.: 88472

Label approval no.: 88472/121396

Application no.: 125049

Product name: Jurox Tulathromycin Injection

Active constituent/s: 100 mg/mL tulathromycin

Applicant name: Jurox Pty Ltd

Applicant ACN: 000 932 230

Summary of use: For the treatment of respiratory infections in pigs and cattle

Date of registration: 27 July 2020

Product registration no.: 89488

Label approval no.: 89488/125049

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 13

Veterinary Chemical Products and Approved Labels

Application no.: 125947

Product name: (Wagg & Purr) Dogs & Puppies Broadspectrum Allwormer

Active constituent/s: 542mg oxantel embonate, 143 mg pyrantel embonate, 50mg praziquantel per tablet

Applicant name: Avet Health Pty Ltd

Applicant ACN: 616 838 101

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

Date of registration: 28 July 2020

Product registration no.: 89743

Label approval no.: 89743/125947

Application no.: 61869

Product name: Seboric Medicated Shampoo

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

Applicant name: Arkolette Pty Ltd

Applicant ACN: 002 776 212

Summary of use: For use as an antibacterial, antifungal, keratolytic and antipruritic shampoo in dogs and cats

Date of registration: 29 July 2020

Product registration no.: 69844

Label approval no.: 69844/61869

2. VARIATIONS OF REGISTRATION

Application no.: 126273

Product name: Pastoral Ag Strikelab Spray-On Sheep Blowfly Treatment

Active constituent/s: 50 g/L dicyclanil

Applicant name: Pullulo Pharm Pty Ltd

Applicant ACN: 622 530 983

Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Pastoral Ag Dicyclanil Spray-On Sheep Blowfly Treatment’ to ‘Pastoral Ag Strikelab Spray-On Sheep Blowfly Treatment’

Date of variation: 7 July 2020

Product registration no.: 85566

Label approval no.: 85566/126273

Application no.: 125351

Product name: Zeromec Premix For Pigs

Active constituent/s: 6 g/kg ivermectin

Applicant name: Abbey Laboratories Pty Ltd

Applicant ACN: 156 000 430

Summary of variation: To add 15g, 30g and 35g pack sizes

Date of variation: 22 July 2020

Product registration no.: 55455

Label approval no.: 55455/125351

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Veterinary Chemical Products and Approved Labels

Application no.: 125414

Product name: Pastoral Ag Tickgard Pour-on for Cattle

Active constituent/s: 25 g/L fluazuron

Applicant name: The Hunter River Company Pty Ltd

Applicant ACN: 133 798 615

Summary of variation: To change the product name and update label in accordance with the Veterinary Labelling Code

Date of variation: 30 July 2020

Product registration no.: 81764

Label approval no.: 81764/125414

3. LABEL APPROVAL

Application no.: 125713

Product name: Enduramec Horse Paste

Active constituent/s: 18.7 g/kg ivermectin

Applicant name: The Hunter River Company Pty Ltd

Applicant ACN: 133 798 615

Summary of variation: To approve a new label for the product ‘Enduramec Horse Paste’ with the label name 'Independents Own Equigard Horse Paste'

Date of variation: 29 July 2020

Product registration no.: 85529

Label approval no.: 85529/125713

Application no.: 125720

Product name: Enduramec With Tape Horse Paste

Active constituent/s: 140.3 mg/g praziquantel, 18.7 mg/g ivermectin

Applicant name: The Hunter River Company Pty Ltd

Applicant ACN: 133 798 615

Summary of variation: To approve a new label for the product ‘Enduramec With Tape Horse Paste’ with the second label name ‘Independents Own Equigard With Tape Horse Paste’

Date of variation: 30 July 2020

Product registration no.: 86692

Label approval no.: 86692/125720

4. VARIATION OF LABEL APPROVAL

Application no.: 125096

Product name: Elanco Compudose-G With Tylan Growth And Finishing Implants For Steers And Heifers

Active constituent/s: 60 mg trenbolone acetate, 29 mg tylosin tartrate, 12 mg oestradiol per implant

Applicant name: Elanco Australasia Pty Ltd

Applicant ACN: 076 745 198

Summary of variation: To update product label in line with the Veterinary Labelling Code

Date of variation: 23 July 2020

Product registration no.: 60373

Label approval no.: 60373/125096

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Veterinary Chemical Products and Approved Labels

Application no.: 125097

Product name: Elanco AH 0323 Oestradiol Compudose 200

Active constituent/s: 25.7 mg oestradiol 17 beta per dose

Applicant name: Elanco Australasia Pty Ltd

Applicant ACN: 076 745 198

Summary of variation: To update product label in line with the Veterinary Labelling Code

Date of variation: 23 July 2020

Product registration no.: 36789

Label approval no.: 36789/125097

Application no.: 125098

Product name: Elanco AH 0343 Oestradiol Compudose 400

Active constituent/s: 43.9 mg oestradiol 17 beta per dose

Applicant name: Elanco Australasia Pty Ltd

Applicant ACN: 076 745 198

Summary of variation: To update product label in line with the Veterinary Labelling Code

Date of variation: 23 July 2020

Product registration no.: 36799

Label approval no.: 36799/125098

Application no.: 125099

Product name: Elanco AH0359 Compudose-G Growth And Finishing Implants For Steers And Heifers

Active constituent/s: Each implant contains 60 mg trenbolone acetate, 12 mg oestradiol

Applicant name: Elanco Australasia Pty Ltd

Applicant ACN: 076 745 198

Summary of variation: To update product label in line with the Veterinary Labelling Code

Date of variation: 23 July 2020

Product registration no.: 56075

Label approval no.: 56075/125099

Application no.: 125123

Product name: Stresnil Neuroleptic Injection For Pigs

Active constituent/s: 40 mg/mL azaperone

Applicant name: Elanco Australasia Pty Ltd

Applicant ACN: 076 745 198

Summary of variation: To update the label in accordance with the Veterinary Labelling Code

Date of variation: 24 July 2020

Product registration no.: 35937

Label approval no.: 35937/125123

Application no.: 123264

Product name: Elanco Cyrex Liquid Sheep Blowfly And Lice Treatment

Active constituent/s: 500 g/L cyromazine, 12.5 g/L spinosad

Applicant name: Elanco Australasia Pty Ltd

Applicant ACN: 076 745 198

Summary of variation: To amend the trade advice, re-treatment interval and critical comments statements of the approved product label

Date of variation: 29 July 2020

Product registration no.: 63384

Label approval no.: 63384/123264

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 16

Approved Active Constituents

Approved Active Constituents

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

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

the approval of the following active constituents, with effect from the dates shown.

1. ACTIVE CONSTITUENT

Application no.: 124239

Active constituent/s: Oxytetracycline hydrochloride

Applicant name: Randlab Australia Pty Ltd

Applicant ACN: 114 948 837

Summary of use: For use in veterinary chemical products

Date of approval: 20 July 2020

Approval no.: 89274

Application no.: 118087

Active constituent/s: Metcamifen

Applicant name: Syngenta Australia Pty Ltd

Applicant ACN: 002 933 717

Summary of use: For use in agricultural chemical products

Date of approval: 21 July 2020

Approval no.: 87316

Application no.: 123469

Active constituent/s: Adenosine 5-monophosphate

Applicant name: RWR Veterinary Products Pty Ltd

Applicant ACN: 088 423 018

Summary of use: For use in veterinary chemical products

Date of approval: 22 July 2020

Approval no.: 89035

Application no.: 120212

Active constituent/s: Itraconazole

Applicant name: Randlab Australia Pty Ltd

Applicant ACN: 114 948 837

Summary of use: For use in veterinary chemical products

Date of approval: 24 July 2020

Approval no.: 88073

Application no.: 121396

Active constituent/s: Ketoprofen

Applicant name: Zoetis Australia Pty Ltd

Applicant ACN: 156 476 425

Summary of use: For use in veterinary chemical products

Date of approval: 24 July 2020

Approval no.: 88713

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 17

Approved Active Constituents

Application no.: 123983

Active constituent/s: N-acetyl-glucosamine

Applicant name: Randlab Australia Pty Ltd

Applicant ACN: 114 948 837

Summary of use: For use in veterinary chemical products

Date of approval: 27 July 2020

Approval no.: 89209

Application no.: 123716

Active constituent/s: Magnesium carbonate

Applicant name: Ranvet Pty Ltd

Applicant ACN: 001 606 033

Summary of use: For use in veterinary chemical products

Date of approval: 29 July 2020

Approval no.: 89135

Application no.: 121978

Active constituent/s: Trifloxysulfuron-sodium

Applicant name: Agroserve Pty Ltd

Applicant ACN: 163 422 464

Summary of use: For use in agricultural chemical products

Date of approval: 29 July 2020

Approval no.: 88681

2. VARIATIONS OF ACTIVE CONSTITUENT

Application no.: 123599

Active constituent/s: Praziquantel

Applicant name: Boehringer Ingelheim Animal Health Australia Pty Ltd

Applicant ACN: 071 187 285

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

Date of variation: 29 July 2020

Approval no.: 81873

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 18

New agricultural active constituent: Aclonifen

New agricultural active constituent: Aclonifen

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

new active constituent, aclonifen, for use in agricultural products as an herbicide.

Common name: Aclonifen

IUPAC name: 2-Chloro-6-nitro-3-phenoxyaniline

Chemical abstracts name: 2-Chloro-6-nitro-3-phenoxybenzenamine

CAS number: 74070-46-5

Molecular formula: C12H9ClN2O3

Molecular weight: 264.7 gmol-1

Structure:

Chemical family: Nitrophenyl ether

Mode of action: Inhibition of both chlorophyll and carotenoid synthesis

SUMMARY OF THE APVMA’S EVALUATION

The APVMA has evaluated the chemistry aspects of aclonifen active constituent (identification, manufacturing process,

declaration of composition, quality control procedures, batch analysis results and analytical methods) and found them to

be acceptable.

Impurities of toxicological significance are not expected to occur in aclonifen as a result of the raw materials and the

synthetic route used.

On the basis of the data provided, and the toxicological assessment, it is proposed that the following APVMA Active

Constituent Standard be established for aclonifen active constituent:

Constituent Specification Level

Aclonifen Aclonifen 980 g/kg minimum on a dry weight basis

The APVMA has considered the toxicological aspects of aclonifen, and concluded that there are no toxicological

concerns regarding the approval of this active constituent. An acceptable daily intake (ADI) of 0.07 mg/kg bw/d for

aclonifen was recommended, and an acute reference dose (ARfD) was considered not to be necessary.

Following advice from the Advisory Committee on Chemical Scheduling (ACCS), the Scheduling Delegate has made an

interim decision to amend the current Poisons Standard to include aclonifen in Schedule 6 of the SUSMP, with no

concentration cut-off. The proposed implementation date is 1 October 2020.

The APVMA is satisfied that the proposed use of aclonifen would not be an undue toxicological hazard to the safety of

people exposed to it during its handling and use.

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New agricultural active constituent: Aclonifen

MAKING A SUBMISSION

In accordance with section 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission

as to whether the application for approval of aclonifen should be granted. Submissions should relate only to matters that

are considered in determining whether the safety criteria set out in section 5A of the Agvet Code have been met.

Submissions should state the grounds on which they are based.

Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact

listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

When making a submission please include:

a contact name

a company or group name (if relevant)

an email or postal address (if available)

the date you made the submission.

All personal and confidential commercial information (CCI)1 material contained in submissions will be treated

confidentially.

Written submissions should be addressed in writing to:

Director of Chemistry and Manufacture

Risk Assessment Capability Program

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300

Email: [email protected].

1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 20

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 (MRL Standard)

Instrument 2019. 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 (MRL Standard) Amendment

Instrument (No. 6) 2020.

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

Standard) Instrument 2019.

The MRL Standard is accessible via the Federal Register of Legislation website.

For further information please contact:

MRL Contact Officer

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2401

Email: [email protected].

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 21

Proposal to amend Schedule 20 in 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 20 of APVMA Gazette No. 16, 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 (MRL Standard) Amendment Instrument (No. 6) 2020) 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.

A Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO) will be made.

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.

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 22

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

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

(11 August 2020)

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] omitting the chemical residue definition for isofetamid and substituting the following

Permitted residue—commodities of plant origin: isofetamid

Permitted residue—commodities of animal origin: sum of isofetamid and 2-[3-methyl-4-[2-methyl-2-(3-methylthiophene-2- carboxamido) propanoyl]phenoxy]propanoic acid (PPA), expressed as isofetamid

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

Agvet chemical: bifenthrin

Permitted residue: bifenthrin

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

T1

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

Agvet chemical: bifenazate

Permitted residue: sum of bifenazate and bifenazate diazene (diazenecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl-3-yl] 1-methylethyl ester), expressed as bifenazate

All other foods except animal food commodities

0.2

Avocado T2

Agvet chemical: bifenthrin

Permitted residue: bifenthrin

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

0.5

Cabbages, head T0.5

Agvet chemical: isofetamid

Permitted residue: isofetamid

Berries and other small fruits [except grapes]

5

Poultry eggs *0.02

Edible offal (mammalian) *0.02

Meat (mammalian) (in the fat) *0.02

Milks *0.02

Milk fats *0.02

Poultry, edible offal of *0.02

Poultry meat (in the fat) *0.02

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

Agvet chemical: metalaxyl

Permitted residue: metalaxyl

Parsley T0.3

Agvet chemical: triadimenol

Permitted residue: triadimenol

Anise myrtle leaves (dried) 0.05

Lemon myrtle leaves (dried) 0.05

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

Agvet chemical: abamectin

Permitted residue: avermectin B1a

Adzuki bean (dry) *0.002

Avocado 0.05

Blackberries 0.1

Blueberries *0.02

Bulb vegetables 0.05

Common bean (dry) (navy bean) *0.002

Cucumber 0.05

Custard apple *0.01

Fruiting vegetables, other than cucurbits [except mushrooms, sweet corn (corn-on-the-cob)]

0.1

Lychee 0.05

Mung bean (dry) *0.002

Mushrooms 0.05

Papaya (pawpaw) 0.1

Passionfruit 0.2

Peas 0.5

Raspberries, red, black 0.1

Root and tuber vegetables *0.01

Squash, summer 0.05

Sweet corn (corn-on-the-cob) 0.05

Agvet chemical: bifenthrin

Permitted residue: bifenthrin

Leafy vegetables [except chervil; mizuna; rucola (rocket)]

*0.01

Agvet chemical: bupirimate

Permitted residue: bupirimate

Egg plant 1

Agvet chemical: carfentrazone-ethyl

Permitted residue: carfentrazone-ethyl

Berries and other small fruits [except grapes]

*0.05

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

Agvet chemical: clofentezine

Permitted residue: clofentezine

Almonds 0.5

Tomato 0.5

Agvet chemical: cyprodinil

Permitted residue: cyprodinil

Bulb vegetables [except fennel, bulb; onion, bulb]

3

Chives 3

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

Bulb vegetables [except fennel, bulb; onion, bulb]

3

Chestnuts 1

Chives 3

Pineapple 5

Agvet chemical: metsulfuron-methyl

Permitted residue: metsulfuron-methyl

Mung bean (dry) 0.2

Agvet chemical: phosphorous acid

Permitted residue: phosphorous acid

Basil T300

Coriander (leaves, roots, stems) T300

Fennel, leaf T300

Parsley T300

Agvet chemical: tolclofos-methyl

Permitted residue: tolclofos-methyl

Lettuce, head *0.01

Lettuce, leaf *0.01

Agvet chemical: triadimenol

Permitted residue: triadimenol

Parsnip 0.2

Radish 0.2

Riberry 0.3

Swede 0.2

Turnip, garden 0.2

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

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 SEPTEMBER 2020

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

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2401

Email: [email protected].

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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2020 Agricultural and Veterinary Chemicals Code Act 1994 26

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

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 proposals (No. 4) gazetted on 2 June 2020 (No. APVMA 11).

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

6, 2020) 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.

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.

Food Standards Australia New Zealand (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].

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

Australia New Zealand Food Standards Code—Schedule 20—Maximum residue limits Variation

Instrument

No. APVMA 6, 2020

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 Third day of August 2020

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

Part 1 Preliminary

1 Name of instrument

This instrument is the Australia New Zealand Food Standards Code—Schedule 20maximum residue limits Variation Instrument No. APVMA 6, 2020 (Amendment Instrument).

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 20Maximum 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.

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

Schedule

Variations to Schedule 20—Maximum residue limits

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

[1.1] inserting in alphabetical order

Agvet chemical: aclonifen

Permitted residue: aclonifen

Barley T*0.01

Edible offal (mammalian) T*0.01

Eggs T*0.01

Meat (mammalian) T*0.01

Milks T*0.01

Poultry meat T*0.01

Poultry, edible offal of T*0.01

Triticale T*0.01

Wheat T*0.01

Agvet chemical: metcamifen

Permitted residue—commodities of plant origin: metcamifen

Permitted residue—commodities of animal origin: sum of metcamifen and 4-(3-methyl-ureido)-benzensulfonamide, expressed as metcamifen

Edible offal (mammalian) *0.03

Eggs *0.03

Meat (mammalian) *0.03

Milks *0.03

Poultry, edible offal of *0.03

Poultry meat *0.03

Sorghum *0.01

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

Agvet chemical: azoxystrobin

Permitted residue: azoxystrobin

Rye 0.1

Triticale 0.1

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

Agvet chemical: chlorantraniliprole

Permitted residue—plant commodities and animal commodities other than milk: chlorantraniliprole

Permitted residue—milk: sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliprole

Maize cereals T*0.01

Sugar cane T0.5

Agvet chemical: cyproconazole

Permitted residue: cyproconazole, sum of isomers

Oats 0.05

Rye *0.02

Triticale *0.02

Agvet chemical: emamectin

Permitted residue: sum of emamectin B1a and emamectin B1b

Maize cereals T*0.01

Wheat, similar grains, and pseudocereals without husks

T*0.01

Agvet chemical: etoxazole

Permitted residue: etoxazole

Cane berries T0.5

Agvet chemical: flonicamid

Permitted residue: flonicamid [N -(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide] and its metabolites TFNA [4-trifluoromethylnicotinic acid], TFNA-AM [4-trifluoromethylnicotinamide] TFNG [N -(4-trifluoromethylnicotinoyl)glycine]

Blackberries T2

Bulb vegetables T0.2

Raspberries, red, black T2

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

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

Eggs T*0.01

Poultry meat T*0.01

Poultry, edible offal of T*0.01

Pulses T0.1

Agvet chemical: indoxacarb

Permitted residue: sum of indoxacarb and its R-isomer

Maize cereals T*0.01

Peppers 0.5

Agvet chemical: linuron

Permitted residue: sum of linuron plus 3,4-dichloroaniline, expressed as linuron

Coriander (leaves, roots, stems) T1

Agvet chemical: napropamide

Permitted residue: napropamide

All other foods except animal food commodities

0.02

Agvet chemical: novaluron

Permitted residue: novaluron

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

0.3

Fruiting vegetables, other than cucurbits 0.2

Leafy vegetables 5

Agvet chemical: permethrin

Permitted residue: permethrin, sum of isomers

Poppy seed T0.2

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

Agvet chemical: prothioconazole

Permitted residue—commodities of plant origin: sum of prothioconazole and prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole

Permitted residue—commodities of animal origin: sum of prothioconazole, prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-3-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol) and prothioconazole-4-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-4-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole

Watermelon T0.2

Agvet chemical: pyridate

Permitted residue: sum of pyridate and metabolites containing 6 chloro-4-hydroxyl-3-phenyl pyridazine, expressed as pyridate

Chick-pea (dry) *0.05

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

Agvet chemical: indoxacarb

Permitted residue: sum of indoxacarb and its R-isomer

Peppers, sweet [capsicum] 0.5

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

Agvet chemical: etoxazole

Permitted residue: etoxazole

Avocado T0.05

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

Rape seed (canola) T0.2

Agvet chemical: glufosinate and glufosinate-ammonium

Permitted residue: sum of glufosinate-ammonium, N-acetyl glufosinate and 3-[hydroxy(methyl)-phosphinoyl] propionic acid, expressed as glufosinate (free acid)

Rape seed (canola) 0.5

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

Agvet chemical: glyphosate

Permitted residue: sum of glyphosate, N-acetyl-glyphosate and aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosate

Barley 20

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Stop Supply: Carbine Chemical Pty Ltd (ACN 169 715 440)

Stop Supply: Carbine Chemical Pty Ltd (ACN 169 715 440)

NOTICE UNDER SECTION 101 OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE SCHEDULED TO

THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994 (CTH) (AGVET CODE)—NO. 19 OF 2020

On 30 July 2020, the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to Carbine

Chemicals Pty Ltd (ACN 169 715 440) (the ‘Company’), pursuant to section 101 of the Agvet Code in relation to the

unregistered chemical products labelled or known as:

a. Adrenamax i. Cyanamax q. Muslamax

b. Amalgamax j. Folamax r. Phoslamax

c. Boostamax k. Gastrazone s. Relaxsen

d. Carbalene l. Haematonic t. Reload

e. Carbelyte m. Instant B u. Stamazene

f. Carbine-E n. Iron Donor v. Thiamax

g. Carb-Iron o. Jetramax w. Volganic

h. Citramax p. Ironamax

(the Products)

This notice required the Company to immediately stop supply of the listed Products; to immediately notify any person

who has possession or custody of the listed Products either directly or indirectly because of a supply by the Company

that they must stop supply of the Products and return it to the Company immediately; and take all necessary steps to

recover all stocks of the listed Products from any person that the Company has either directly or indirectly supplied the

Products to.

COMPANY DETAILS

Carbine Chemicals Pty Ltd (ACN 169 715 440)

39 Chambers Road

Altona North VIC 3025

APVMA CONTACT

For further information please contact:

Director, Compliance and Monitoring

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300

Email: [email protected].

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Stop Supply: SJ Enterprises Pty Ltd (ACN 133 549 130)

Stop Supply: SJ Enterprises Pty Ltd (ACN 133 549 130)

NOTICE UNDER SECTION 101 OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE SCHEDULED TO

THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994 (CTH) (AGVET CODE)—NO. 20 OF 2020

On 31 July 2020, the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to SJ

Enterprises Pty Ltd ACN (133 549 130) (the ‘Company’), pursuant to section 101 of the Agvet Code in relation to the

unregistered chemical product labelled or known as, Cyco Platinum Series Cyclone Rooting Gel.

This notice required the Company to immediately stop supply of Cyco Platinum Series Cyclone Rooting Gel; to

immediately notify any person who has possession or custody of Cyco Platinum Series Cyclone Rooting Gel either

directly or indirectly because of a supply by the Company that they must stop supply of Cyco Platinum Series Cyclone

Rooting Gel and return it to the Company immediately; and take all necessary steps to recover all stocks of Cyco

Platinum Series Cyclone Rooting Gel from any person that the Company has either directly or indirectly supplied Cyco

Platinum Series Cyclone Rooting Gel to.

COMPANY DETAILS

SJ Enterprises Pty Ltd (ACN 133 549 130)

7 O’Connor Court

Gepps Cross SA 5094

APVMA CONTACT

For further information please contact:

Director, Compliance and Monitoring

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300

Email: [email protected].

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Stop Supply: Katpet Pty Ltd (ACN 618 282 296)

Stop Supply: Katpet Pty Ltd (ACN 618 282 296)

NOTICE UNDER SECTION 101 OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE SCHEDULED TO

THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994 (CTH) (AGVET CODE) - NO. 21 OF 2020

On 31 July 2020, the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to Katpet Pty

Ltd (ACN 618 282 296) (the ‘Company’), pursuant to section 101 of the Agvet Code in relation to the unregistered

chemical products labelled or known as:

a) Dooda Flea and Tick Collar

b) ティアローズ 非ステロイド性抗炎症点眼剤 5ml (Tear Rose Nonsteroidal anti-inflammatory eye drops 5ml)

c) ヒビクス®軟 膏製造発売元フジタ製薬株式会社 7.5ml (Hibix Ointment Fujita Pharmaceutical Co., Ltd. 7.5ml)

d) Meredith Pharma Itraconazole 60ml

e) Pfizer Terramycin Ophthalmic Ointment 3.5gm

f) Zoetis Synulox 阿莫西林克拉维酸钾片50mg (Zoetis Synulox Amoxicillin and Clavulanate Potassium Tablets 50mg)

g) KATPET Supernatural Oil

(the Products)

This notice required the Company to immediately stop supply of the Products; to immediately notify any person who has

possession or custody of the Products either directly or indirectly because of a supply by the Company that they must

stop supply of the Products and return it to the Company immediately; and take all necessary steps to recover all stocks

of the Products from any person that the Company has either directly or indirectly supplied the Products to.

COMPANY DETAILS

Katpet Pty Ltd (ACN 618 282 296)

10 Cavendish Street

Concord West NSW 2138

APVMA CONTACT

For further information please contact:

Director, Compliance and Monitoring

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300

Email: [email protected].

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Stop Supply: Fluidra Group Australia Pty Ltd (ACN 002 641 965)

Stop Supply: Fluidra Group Australia Pty Ltd (ACN 002 641 965)

NOTICE UNDER SECTION 103 OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE SCHEDULED TO

THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994 (CTH) (AGVET CODE)—NO. 22 OF 2020

On 31 July 2020, the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to Fluidra Group

Australia Pty Ltd (ACN 002 641 965 ) (the ‘Company’ ), pursuant to section 103 of the Agvet Code in relation to the

following registered agricultural chemical products labelled or known as:

a) APVMA No. 80938 Baracuda Granular Chlorine 2kg, 4kg and 10kg

b) APVMA No. 80970 Baracuda Spa Bromine Tablets 1kg

c) APVMA No. 80979 Baracuda Weekly Chlorine Tablets 1kg and 2kg

d) APVMA No. 80981 Baracuda Multi Action Chlorine Tablets 2kg

e) APVMA No. 80989 Baracuda Triple Action Chorine 2kg, 4kg and 10kg

f) APVMA No. 80991 Baracuda Xtreme Shock 500g pkt, 2kg and 4kg

g) APVMA No. 85683 Baracuda Power Maxx Pool Tablets 1kg, 2kg

h) APVMA No. 80939 Baracuda Liquid Chlorine 5 litre and 20 litre

i) APVMA No. 30828 Swimfree Granular Pool Chlorine 10kg

j) APVMA No. 69462 Woolworth Essentials Triple Action Stabilised Pool Chlorine 10kg

k) APVMA No. 82199 Alginox Pool Algaecide 2.5L

l) APVMA No. 80986 Baracuda Pool Algaecide 5L

(the Products)

This notice required the Company to immediately stop supply of non-compliant Products to any person, to immediately

notify any person who has possession or custody of the Products either directly or indirectly because of a supply by the

Company that they must stop supply of the non-compliant Products and return it to the Company immediately, to take all

steps necessary to recover all stocks of the non-compliant Products from any person that the Company has either

directly or indirectly supplied the Products to and where the batch number of the Products is known, attach labels to the

containers of the Products that are the same as the approved label for the Products or otherwise destroy the Products

(including recovered stock).

A report is to be provided to the APVMA outlining actions taken to comply with this Notice.

COMPANY DETAILS

Fluidra Group Australia Pty Ltd (ACN 002 641 965)

219 Woodpark Road

Smithfield NSW 2164

APVMA CONTACT

For further information please contact:

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Stop Supply: Fluidra Group Australia Pty Ltd (ACN 002 641 965)

Director, Compliance and Monitoring

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300

Email: [email protected].