Gazette No 11, Tuesday 1 June 2021

23
Commonwealth of Australia Gazette Agricultural and veterinary chemicals No. APVMA 11, Tuesday 1 June 2021 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

Transcript of Gazette No 11, Tuesday 1 June 2021

Page 1: Gazette No 11, Tuesday 1 June 2021

Commonwealth

of Australia

Gazette

Agricultural and veterinary chemicals

No. APVMA 11, Tuesday 1 June 2021

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: Gazette No 11, Tuesday 1 June 2021

© Commonwealth of Australia 2021

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 (APVMA).

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 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 required by the Agricultural and Veterinary

Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material issued by the APVMA.

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

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

notifications 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 a

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

For enquiries on APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.

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iii

Contents

Erratum notice ................................................................................................................................................................. iii

Agricultural chemical products and approved labels ....................................................................................................... 1

Veterinary chemical products and approved labels ......................................................................................................... 9

Approved active constituents ........................................................................................................................................ 14

Amendments to the APVMA MRL Standard .................................................................................................................. 16

Proposal to amend Schedule 20 in the Australian New Zealand Food Standards Code ............................................... 17

List of tables

Table 1: Agricultural products based on existing active constituents .............................................................................. 1

Table 2: Variations of registration .................................................................................................................................... 3

Table 3: Label approval ................................................................................................................................................... 7

Table 4: Veterinary products based on existing active constituents ................................................................................ 9

Table 5: Variations of registration .................................................................................................................................. 11

Table 6: Label approval ................................................................................................................................................. 12

Table 7: Variation of label approval ............................................................................................................................... 13

Table 8: Active constituent ............................................................................................................................................ 14

Table 9: Variations of active constituent ........................................................................................................................ 15

Erratum notice

The Australian Pesticides and Veterinary Medicines Authority advises that an error was published in the

Commonwealth of Australia Gazette for Agricultural and Veterinary Chemicals, No. APVMA 10, Tuesday 18 May 2021.

In the notice, ADAMA Di-Bak G Herbicide was listed with incorrect product registration and label numbers.

The product is relisted on page 1 of this Gazette with the correct product registration and label numbers.

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1 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.

Table 1: Agricultural products based on existing active constituents

Application no. 129801

Product name ADAMA Di-Bak G Herbicide

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

Applicant name ADAMA Australia Pty Ltd

Applicant ACN 050 328 973

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

public service areas

Date of registration 26 April 2021

Product registration no. 90694

Label approval no. 90694/129801

Application no. 130048

Product name CropSure Boscolan 500WG Fungicide

Active constituent/s 500 g/kg boscalid

Applicant name CropSure Pty Ltd

Applicant ACN 643 829 190

Summary of use For the control of bunch rot (Botrytis cinerea) in grapevines

Date of registration 10 May 2021

Product registration no. 90794

Label approval no. 90794/130048

Application no. 129866

Product name OzCrop Glufos 800 SG Herbicide

Active constituent/s 800 g/kg glufosinate-ammonium

Applicant name OzCrop Pty Ltd

Applicant ACN 160 656 431

Summary of use For the control of broadleaf and grass weeds in various situations as indicated in the directions for use

Date of registration 10 May 2021

Product registration no. 90716

Label approval no. 90716/129866

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Commonwealth of Australia Gazette No. APVMA 11, Tuesday 1 June 2021 2

Application no. 130122

Product name CropSure Cabretta 250EC Fungicide

Active constituent/s 250 g/L pyraclostrobin

Applicant name CropSure Pty Ltd

Applicant ACN 643 829 190

Summary of use For the control of leaf speckle and leaf spot in bananas and downy and powdery mildew in grapevines,

husk spot in macadamia and rust in almond

Date of registration 11 May 2021

Product registration no. 90822

Label approval no. 90822/130122

Application no. 130049

Product name Sinon Atrazine 900 Granule Herbicide

Active constituent/s 900 g/kg atrazine

Applicant name Sinon Australia Pty Ltd

Applicant ACN 102 741 024

Summary of use For the control of weeds and grasses in sorghum, maize, sugar cane, TT canola, lucerne and fallow

area maintenance

Date of registration 11 May 2021

Product registration no. 90795

Label approval no. 90795/130049

Application no. 130169

Product name MLChem Glyphosate 700 SG Herbicide

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

Applicant name AgMerch Pty Ltd

Applicant ACN 645 371 017

Summary of use For use as a non-selective herbicide for the control of many annual and perennial weeds

Date of registration 11 May 2011

Product registration no. 90834

Label approval no. 90834/130169

Application no. 126325

Product name IRONMAX Pro Slug and Snail Bait

Active constituent/s 9.0 g/kg iron present as iron phosphate anhydrous

Applicant name De Sangosse SA

Applicant ACN N/A

Summary of use For the control of slugs and snails in agricultural and horticultural crops and other situations where

slugs and snails congregate

Date of registration 13 May 2021

Product registration no. 89908

Label approval no. 89908/126325

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3 Agricultural chemical products and approved labels

Application no. 125844

Product name SmartFresh InBox Post-harvest Growth Regulator

Active constituent/s 0.14 g/kg 1-methylcyclopropene

Applicant name AgroFresh Australia Pty Ltd

Applicant ACN 602 871 803

Summary of use For post-harvest treatment of certain fruits and vegetables to maintain quality during shipping, storage

or handling

Date of registration 14 May 2021

Product registration no. 89703

Label approval no. 89703/125844

Application no. 126297

Product name Tetrino Turf Insecticide

Active constituent/s 42.8 g/L tetraniliprole

Applicant name Bayer CropScience Pty Ltd

Applicant ACN 000 226 022

Summary of use For the control of insect pests in turf

Date of registration 17 May 2021

Product registration no. 89889

Label approval no. 89889/126297

Application no. 124852

Product name Prozap Zinc Phosphide Pellets

Active constituent/s 20 g/kg zinc phosphide

Applicant name Neogen Corporation

Applicant ACN N/A

Summary of use For the control of heavy infestations of mice in agricultural situations

Date of registration 21 May 2021

Product registration no. 89431

Label approval no. 89431/124852

Table 2: Variations of registration

Application no. 130782

Product name Outshine Herbicide

Active constituent/s 100 g/L fluroxypyr present as the methylheptyl ester, 2.5 g/L florasulam

Applicant name ADAMA Australia Pty Ltd

Applicant ACN 050 328 973

Summary of use To remove the use with Zulu XT (2,4-D amine) from the instructions

Date of registration 30 April 2021

Product registration no. 84528

Label approval no. 84528/130782

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Commonwealth of Australia Gazette No. APVMA 11, Tuesday 1 June 2021 4

Application no. 130798

Product name Aviator XPro Foliar Fungicide

Active constituent/s 150 g/L prothioconazole, 75 g/L bixafen

Applicant name Bayer CropScience Pty Ltd

Applicant ACN 000 226 022

Summary of use To vary the general instructions statements to wash the spray unit to reduce any effects to the

rubber/composite components due to the solvent in the product

Date of registration 3 May 2021

Product registration no. 69361

Label approval no. 69361/130798

Application no. 130886

Product name Silawrap Max Gibberellic Acid Growth Regulant

Active constituent/s 100 g/L gibberellic acid

Applicant name Australian Adjuvants Pty Ltd

Applicant ACN 614 361 705

Summary of use To vary the distinguishing product name and the name that appears on the label from ‘ADAMA

Gibberellic Acid Growth Regulant’ to ‘Silawrap Max Gibberellic Acid Growth Regulant’

Date of registration 10 May 2021

Product registration no. 46740

Label approval no. 46740/130886

Application no. 130237

Product name Baton Low Herbicide

Active constituent/s 800 g/kg 2,4-D present as the dimethylamine salt

Applicant name Nufarm Australia Limited

Applicant ACN 004 377 780

Summary of use To amend the product registration and label in line with the 2,4-D reconsideration final regulatory

decision

Date of registration 11 May 2021

Product registration no. 46314

Label approval no. 46314/130237

Application no. 130027

Product name Pyresta LV Herbicide

Active constituent/s 421 g/L 2,4-D present as the 2-ethylhexyl ester, 2.1 g/L pyraflufen-ethyl

Applicant name Sipcam Pacific Australia Pty Ltd

Applicant ACN 073 176 888

Summary of use To amend the product registration and label in line with the 2,4-D reconsideration final regulatory

decision

Date of registration 11 May 2021

Product registration no. 61328

Label approval no. 61328/130027

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5 Agricultural chemical products and approved labels

Application no. 129818

Product name Mortein Powergard The Expert's Flying Insect Killer

Active constituent/s 3.15 g/kg tetramethrin 20:80, 0.9 g/kg allethrin 20:80, 0.9 g/kg phenothrin-D 20:80

Applicant name RB (Hygiene Home) Australia Pty Ltd

Applicant ACN 629 549 506

Summary of use To amend the statement of claims to include a comparative performance claim

Date of registration 11 May 2021

Product registration no. 53236

Label approval no. 53236/129818

Application no. 130241

Product name Zephyr 625 2,4-D Low Odour Herbicide

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

Applicant name Nufarm Australia Limited

Applicant ACN 004 377 780

Summary of use To amend the product label in line with the 2,4-D reconsideration final regulatory decision

Date of registration 11 May 2021

Product registration no. 58990

Label approval no. 58990/130241

Application no. 129208

Product name EuroChem Dungeon 700 WG Fungicide

Active constituent/s 700 g/kg dithianon

Applicant name EuroChem Pty Ltd

Applicant ACN 622 603 507

Summary of use To add uses in pears, stone fruits and grapevines

Date of registration 12 May 2021

Product registration no. 87475

Label approval no. 87475/129208

Application no. 129820

Product name Mortein Powergard The Expert's Multi Insect Killer

Active constituent/s 1.0 g/kg esbiothrin, 0.7 g/kg imiprothrin, 0.3 g/kg permethrin

Applicant name RB (Hygiene Home) Australia Pty Ltd

Applicant ACN 629 549 506

Summary of use To amend the statement of claims to include a comparative performance claim

Date of registration 12 May 2021

Product registration no. 83812

Label approval no. 83812/129820

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Commonwealth of Australia Gazette No. APVMA 11, Tuesday 1 June 2021 6

Application no. 130154

Product name GP Regain 400 Herbicide

Active constituent/s 400 g/kg tebuthiuron

Applicant name Granular Products Assets Pty Ltd

Applicant ACN 614 694 405

Summary of use To add aerial application in Western Australia

Date of registration 12 May 2021

Product registration no. 69266

Label approval no. 69266/130154

Application no. 129064

Product name 4Farmers Pendimethalin 440EC Herbicide

Active constituent/s 440 g/L pendimethalin

Applicant name 4 Farmers Australia Pty Ltd

Applicant ACN 160 092 428

Summary of use To include claims for the suppression of brome grass in wheat and barley

Date of registration 14 May 2021

Product registration no. 88810

Label approval no. 88810/129064

Application no. 128771

Product name Radial Fungicide

Active constituent/s 75 g/L azoxystrobin, 75 g/L epoxiconazole

Applicant name ADAMA Australia Pty Ltd

Applicant ACN 050 328 973

Summary of use To add additional claims in wheat and barley; add uses in oats; and amend the withholding periods

and export slaughter interval

Date of registration 18 May 2021

Product registration no. 68194

Label approval no. 68194/128771

Application no. 129957

Product name Spartan Herbicide

Active constituent/s 480 g/L prodiamine

Applicant name Turf Culture Pty Ltd

Applicant ACN 117 986 615

Summary of use To update the re-seeding statement intervals

Date of registration 24 May 2021

Product registration no. 88727

Label approval no. 88727/129957

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7 Agricultural chemical products and approved labels

Table 3: Label approval

Application no. 130514

Product name Earthcare White Oil Insect Spray

Active constituent/s 19.7 g/L paraffin oil

Applicant name Seasol International Pty Ltd

Applicant ACN 006 490 240

Summary of use To approve a new label for the product 'Earthcare White Oil Insect Spray' with the label name 'Sharp

Shooter Enviro Pest Oil Insect Spray'

Date of registration 10 May 2021

Product registration no. 62139

Label approval no. 62139/130514

Application no. 130517

Product name Earthcare Natural Pyrethrum Insect Spray

Active constituent/s 1.2 g/L piperonyl butoxide, 0.3 g/L pyrethrins

Applicant name Seasol International Pty Ltd

Applicant ACN 006 490 240

Summary of use To approve a new label for the product 'Earthcare Natural Pyrethrum Insect Spray' with the label name

'Sharp Shooter Natural Pyrethrum Insect Spray’

Date of registration 10 May 2021

Product registration no. 58756

Label approval no. 58756/130517

Application no. 130521

Product name Earthcare Rose Black Spot & Insect Spray

Active constituent/s 0.1 g/L tau-fluvalinate, 0.05 g/L myclobutanil

Applicant name Seasol International Pty Ltd

Applicant ACN 006 490 240

Summary of use To approve a new label for the product 'Earthcare Rose Black Spot & Insect Spray' with the label name

'Sharp Shooter Rose Black Spot & Insect Spray'

Date of registration 10 May 2021

Product registration no. 58196

Label approval no. 58196/130521

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Commonwealth of Australia Gazette No. APVMA 11, Tuesday 1 June 2021 8

Application no. 130210

Product name Roundup 360 Concentrate Weedkiller

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

Applicant name Evergreen Garden Care Australia Pty Ltd

Applicant ACN 003 123 162

Summary of use To approve a new label for the product 'Roundup 360 Concentrate Weedkiller' with the label name

'Advance Roundup Concentrate Weedkiller'

Date of registration 12 May 2021

Product registration no. 87668

Label approval no. 87668/130210

Application no. 130211

Product name Roundup 360 Concentrate Weedkiller

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

Applicant name Evergreen Garden Care Australia Pty Ltd

Applicant ACN 003 123 162

Summary of use To approve a new label for the product 'Roundup 360 Concentrate Weedkiller' with the label name

'Roundup Concentrate Weedkiller All Purpose'

Date of registration 12 May 2021

Product registration no. 87668

Label approval no. 87668/130211

Application no. 130212

Product name Roundup 360 Concentrate Weedkiller

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

Applicant name Evergreen Garden Care Australia Pty Ltd

Applicant ACN 003 123 162

Summary of use To approve a new label for the product 'Roundup 360 Concentrate Weedkiller' with the label name

'Roundup P1 Concentrate Weedkiller'

Date of registration 12 May 2021

Product registration no. 87668

Label approval no. 87668/130212

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9 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.

Table 4: Veterinary products based on existing active constituents

Application no. 129619

Product name Troy PetVantage for Kittens and Small Cats up to 4 Kg

Active constituent/s 100 g/L imidacloprid, 10 g/L moxidectin

Applicant name Troy Laboratories Pty Ltd

Applicant ACN 000 283 769

Summary of use For the treatment and prevention of fleas, prevention of heartworm infection and treatment and control

of intestinal worms and larvae in kittens and cats weighing up to 4 kg

Date of registration 11 May 2021

Product registration no. 90624

Application no. 129620

Product name Troy PetVantage for Cats over 4kg

Active constituent/s 100 g/L imidacloprid, 10 g/L moxidectin

Applicant name Troy Laboratories Pty Ltd

Applicant ACN 000 283 769

Summary of use For the treatment and prevention of fleas, prevention of heartworm infection and treatment and control

of intestinal worms and larvae in cats weighing over 4 kg

Date of registration 11 May 2021

Product registration no. 90625

Label approval no. 90625/129620

Application no. 129125

Product name Blitz Pour-on 35 g/L Lousicide for Sheep

Active constituent/s 35 g/L imidacloprid

Applicant name Pullulo Pharm Pty Ltd

Applicant ACN 622 530 983

Summary of use For use as a control of neonicotinoid-susceptible sheep body lice (Bovicola ovis) in sheep off-shears

(within 7 days of shearing) and unshorn lambs up to 2 months of age

Date of registration 12 May 2021

Product registration no. 90498

Label approval no. 90498/129125

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Commonwealth of Australia Gazette No. APVMA 11, Tuesday 1 June 2021 10

Application no. 129934

Product name Vetmec Tickmaster Plus Ivermectin Pour-on for Cattle

Active constituent/s 15 g/L fluazuron, 5 g/L ivermectin

Applicant name Chemvet Australia Pty Ltd

Applicant ACN 138 711 289

Summary of use For the treatment and control of ivermectin-sensitive internal and external parasites as well as the

strategic control of fluazuron susceptible tick (Rhipicephalus miroplus) in beef cattle

Date of registration 17 May 2021

Product registration no. 90748

Label approval no. 90748/129934

Application no. 129924

Product name Vetmec Tickmaster Pour-on For Cattle

Active constituent/s 25 g/L fluazuron

Applicant name Chemvet Australia Pty Ltd

Applicant ACN 138 711 289

Summary of use For the strategic control of fluazuron-susceptible cattle tick Rhipicephalus microplus, including strains

resistant to organophosphates, synthetic pyrethroids and amidines, on beef cattle

Date of registration 17 May 2021

Product registration no. 90743

Label approval no. 90743/129924

Application no. 124684

Product name Tulaven Injectable Solution

Active constituent/s 100 mg/mL tulathromycin

Applicant name Ceva Animal Health Pty Ltd

Applicant ACN 002 692 426

Summary of use For the treatment of respiratory infections associated with strains sensitive to tulathromycin in cattle

and swine

Date of registration 18 May 2021

Product registration no. 89410

Label approval no. 89410/124684

Application no. 129908

Product name Zolvix Plus Dual Use Anthelmintic for Sheep and Cattle

Active constituent/s 25 mg/mL monepantel, 2 mg/mL abamectin

Applicant name Elanco Australasia Pty Ltd

Applicant ACN 076 745 198

Summary of use For the treatment and control of sensitive strains of nematodes (roundworms) in sheep and cattle

Date of registration 18 May 2021

Product registration no. 90738

Label approval no. 90738/129908

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11 Veterinary chemical products and approved labels

Application no. 125310

Product name Aqua One White Spot Remedy

Active constituent/s 37 mg/mL formaldehyde, 0.32 mg/mL malachite green

Applicant name Kong's (Aust) Pty Ltd

Applicant ACN 050 291 766

Summary of use For the registration of a topical solution product for use in freshwater aquarium fish for the treatment of

white spot disease

Date of registration 20 May 2021

Product registration no. 89576

Label approval no. 89576/125310

Table 5: Variations of registration

Application no. 130914

Product name ilium Dexason Anti-Inflammatory and Glucogenic Steroid Injection

Active constituent/s 2 mg/mL dexamethasone as the sodium phosphate

Applicant name Troy Laboratories Pty Ltd

Applicant ACN 000 283 769

Summary of use To vary the distinguishing product name and the name that appears on the label from ‘Dexason Anti-

Inflammatory And Glucogenic Steroid Injection’ to ‘Ilium Dexason Anti-Inflammatory and Glucogenic

Steroid Injection’

Date of registration 10 May 2021

Product registration no. 52859

Label approval no. 52859/130914

Application no. 129753

Product name Cocciprol

Active constituent/s 200 g/kg amprolium as amprolium hydrochloride

Applicant name Vetsense Pty Ltd

Applicant ACN 150 968 871

Summary of use To add pack sizes: 10 kg, 15 kg and 20 kg

Date of registration 11 May 2021

Product registration no. 88154

Label approval no. 88154/129753

Application no. 129860

Product name Juraclox L.A. 600 Dry Cow Long Acting Intramammary Suspension

Active constituent/s 600 mg/3.6 g syringe cloxacillin as the benzathine salt

Applicant name Jurox Pty Ltd

Applicant ACN 000 932 230

Summary of use To vary the use of the product in line with good antimicrobial stewardship

Date of registration 11 May 2021

Product registration no. 50239

Label approval no. 50239/129860

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Commonwealth of Australia Gazette No. APVMA 11, Tuesday 1 June 2021 12

Application no. 128528

Product name CLiK Extra Spray-On Sheep Blowfly Treatment

Active constituent/s 65 g/L dicyclanil

Applicant name Elanco Australasia Pty Ltd

Applicant ACN 076 745 198

Summary of use To vary the relevant particulars to change the dose table for sheep >31 kg and the variation to

application pattern for sheep <31 kg on the approved label

Date of registration 17 May 2021

Product registration no. 81863

Label approval no. 81863/128528

Application no. 129489

Product name Kefvet Oral Antibiotic Drops for Dogs and Cats

Active constituent/s 150 mg/g cephalexin

Applicant name Bocko Pty Ltd & Flexsky Pty Ltd in partnership

Applicant ACN 147 389 678

Summary of use To add a 13.34 g and a 26.68 g pack size

Date of registration 21 May 2021

Product registration no. 89760

Label approval no. 89760/129489

Table 6: Label approval

Application no. 130787

Product name YP Tilmicosin Injectable

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

Applicant name South Yarra Pharma Pty Ltd

Applicant ACN 629 173 351

Summary of use To vary the distinguishing product name and the name that appears on the label from ‘Bovatil 300’ to

‘YP Tilmicosin Injectable’

Date of registration 28 April 2021

Product registration no. 88108

Label approval no 88108/130787

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13 Veterinary chemical products and approved labels

Table 7: Variation of label approval

Application no. 127372

Product name NV Salsprin Injection

Active constituent/s 250 mg/mL sodium salicylate

Applicant name Ceva Animal Health Pty Ltd

Applicant ACN 002 692 426

Summary of use To vary the label approval to add an in-use shelf-life statement

Date of registration 21 May 2021

Product registration no. 51161

Label approval no. 51161/127372

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Commonwealth of Australia Gazette No. APVMA 11, Tuesday 1 June 2021 14

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.

Table 8: Active constituent

Application no. 129523

Active constituent/s Captan

Applicant name Aimco Kr Australia Pty Ltd

Applicant ACN 145 929 924

Summary of use For use in agricultural chemical products

Date of approval 10 May 2021

Approval no. 90622

Application no. 126167

Active constituent/s Bifenthrin

Applicant name Bharat Rasayan Limited

Applicant ACN N/A

Summary of use For use in agricultural chemical products

Date of approval 11 May 2021

Approval no. 89812

Application no. 128164

Active constituent/s Sodium hyaluronate

Applicant name Vetoquinol Australia Pty Ltd

Applicant ACN 006 949 480

Summary of use For use in veterinary chemical products

Date of approval 11 May 2021

Approval no. 90225

Application no. 124844

Active constituent/s Flubendiamide

Applicant name Shandong Rainbow International Co Ltd

Applicant ACN N/A

Summary of use For use in agricultural chemical products

Date of approval 21 May 2021

Approval no. 89429

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15 Approved active constituents

Table 9: Variations of active constituent

Application no. 126136

Active constituent/s Sodium selenate

Applicant name Zoetis Australia Pty Ltd

Applicant ACN 156 476 425

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

Date of approval 17 May 2021

Approval no. 84267

Application no. 129469

Active constituent/s Omeprazole

Applicant name Ceva Animal Health Pty Ltd

Applicant ACN 002 692 426

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

Date of approval 17 May 2021

Approval no. 82185

Application no. 129944

Active constituent/s Phthalylsulfathiazole

Applicant name Jurox Pty Ltd

Applicant ACN 000 932 230

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

Date of approval 26 May 2021

Approval no. 56217

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Commonwealth of Australia Gazette No. APVMA 11, Tuesday 1 June 2021 16

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. 5) 2021.

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 2300

Email: [email protected]

Page 20: Gazette No 11, Tuesday 1 June 2021

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

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

In the previous notice on page 19 of APVMA Gazette No. 11, 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 in the APVMA’s MRL Standard.

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

variations (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2021

(No. 5)) to MRLs into Schedule 20 – Maximum residue limits in the Australia New Zealand Food Standards Code.

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

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

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

The APVMA and Food Standards Australia New Zealand (FSANZ) are satisfied, based on dietary exposure assessments

and current health standards, that the proposed limits are not harmful to public health.

The agreement between the Australian Government and the New Zealand Government concerning a Joint Food

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

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

chemicals in food.

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

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

notice, below the details of the proposed amendment.

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

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

effect as from the date of that subsequent notice.

Page 21: Gazette No 11, Tuesday 1 June 2021

Commonwealth of Australia Gazette No. APVMA 11, Tuesday 1 June 2021 18

Proposed variation to Schedule 20 in the Australia New

Zealand Food Standards Code

1 June 2021

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 from each of the following chemicals, the foods and associated MRLs

Agvet chemical: Pyriproxyfen

Permitted residue: Pyriproxyfen

Beans [except broad bean; soya bean]

T0.5

Yard-long bean (pods) T0.5

Agvet chemical: Saflufenacil

Permitted residue – Commodities of plant origin: Sum of saflufenacil, N′-{2-chloro-4-fluoro-5-[1,2,3,6-tetrahydro-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]benzoyl-N-isopropyl sulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino}

carbonyl)phenyl]urea, expressed as saflufenacil equivalents

Permitted residue – Commodities of animal origin: Saflufenacil

Oilseed *0.03

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

Agvet chemical: Isopyrazam

Permitted residue: Isopyrazam

All other foods except animal food commodities

0.01

Almonds *0.01

Agvet chemical: Isoxaflutole

Permitted residue: Sum of isoxaflutole and 2-cyclopropylcarbonyl-3-(2-methylsulfonyl-4-trifluoromethylphenyl)-3-oxopropanenitrile, expressed as isoxaflutole

All other foods except animal food commodities

0.02

Pineapple *0.02

Page 22: Gazette No 11, Tuesday 1 June 2021

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

Agvet chemical: Mesotrione

Permitted residue: Mesotrione

Sweet corn (corn-on-the-cob) T*0.01

Agvet chemical: Methomyl

Permitted residue: Methomyl

Pitaya (dragon fruit) T0.2

Agvet chemical: Metribuzin

Permitted residue: Metribuzin

Pineapple *0.01

Agvet chemical: Pyriproxyfen

Permitted residue: Pyriproxyfen

Beans with pods T0.3

Agvet chemical: Saflufenacil

Permitted residue – Commodities of plant origin: Sum of saflufenacil, N′-{2-chloro-4-fluoro-5-[1,2,3,6-tetrahydro-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]benzoyl-N-isopropyl sulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino}

carbonyl)phenyl]urea, expressed as saflufenacil equivalents

Permitted residue – Commodities of animal origin: Saflufenacil

Linseed T0.5

Oilseed [except cotton seed; linseed; rapeseed; sunflower seed]

*0.03

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

Agvet chemical: Bromoxynil

Permitted residue: Bromoxynil

Onion, bulb *0.01

Page 23: Gazette No 11, Tuesday 1 June 2021

Commonwealth of Australia Gazette No. APVMA 11, Tuesday 1 June 2021 20

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 and surveys. 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

Submissions must be received by 29 June 2021. Submissions received after this deadline will only be considered by

prior arrangement or 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.

Please note: submissions will be published on the APVMA’s website, unless you have asked for the submission to

remain confidential, or if the APVMA chooses at its discretion not to publish any submissions received (refer to the public

consultation coversheet).

Please lodge your submission using the public consultation coversheet, which provides options for how your submission

will be published.

Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may

be required to be released under that Act should a request for access be made.

For further information please contact:

MRL Contact Officer

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300

Email: [email protected]

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