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Gazette Agricultural and Veterinary Chemicals No. APVMA 24, Tuesday, 1 December 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.
Transcript

APVMA Gazette No. 24, 1 December 2020

Gazette

Agricultural and

Veterinary Chemicals

No. APVMA 24, Tuesday, 1 December 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.

2Agricultural and Veterinary Chemicals Code Act 1994Commonwealth of Australia Gazette

No. APVMA 2-3 February 2009

ISSN 1837-7629

© 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, CommunicationsAustralian Pesticides and Veterinary Medicines AuthorityGPO 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 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 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.

CONTENTS

Agricultural Chemical Products and Approved Labels4

Veterinary Chemical Products and Approved Labels14

Approved Active Constituents17

New Agricultural Active Constituent: Acequinocyl19

Amendments to the APVMA MRL Standard21

Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code22

Variations to Schedule 20 of the Australia New Zealand Food Standards Code27

Stop Supply: Fleamail Pty Ltd (ACN 637 942 128)32

Stop Supply: Ausrichter Pty Ltd (ACN 000 908 529)34

Commonwealth of Australia Gazette

No. APVMA 24, Tuesday, 1 December 2020Agricultural and Veterinary Chemicals Code Act 19943

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.

agricultural Products Based on Existing Active Constituents

Application no.:

124765

Product name:

HL Clethodim 240 Herbicide

Active constituent/s:

240 g/L clethodim

Applicant name:

Hebei Lansheng Biotech Co Ltd

Applicant ACN:

N/A

Summary of use:

For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas, cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, lettuce, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans

Date of registration:

3 July 2020

Product registration no.:

89416

Label approval no.:

89416/124765

Application no.:

120808

Product name:

Yates Grub Kill & Protect For Lawns C Up To 6 Months Protection Against Curl Grub

Active constituent/s:

200 g/L chlorantraniliprole

Applicant name:

Syngenta Australia Pty Ltd

Applicant ACN:

002 933 717

Summary of use:

For the control of lawn grubs in the home garden

Date of registration:

10 July 2020

Product registration no.:

88297

Label approval no.:

88297/120808

Application no.:

122563

Product name:

Searles Dead Grub Pro Hose-On For Lawns

Active constituent/s:

4.8 g/L bifenthrin

Applicant name:

J.C. & A.T. Searle Pty Ltd

Applicant ACN:

002 898 893

Summary of use:

To control lawn beetles and lawn grubs in the home garden

Date of registration:

13 August 2020

Product registration no.:

88821

Label approval no.:

88821/122563

Application no.:

127160

Product name:

eChem e-Strobin 250 SC Fungicide

Active constituent/s:

250 g/L azoxystrobin

Applicant name:

eChem (Australia) Pty Ltd

Applicant ACN:

089 133 095

Summary of use:

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

Date of registration:

28 October 2020

Product registration no.:

90038

Label approval no.:

90038/127160

Application no.:

123025

Product name:

Nufarm Amishield 500WG Fungicide

Active constituent/s:

500 g/kg amisulbrom

Applicant name:

Nufarm Australia Limited

Applicant ACN:

004 377 780

Summary of use:

For control of clubroot and suppression of damping off in brassicas and the control of powdery scab and suppression of pink rot in potatoes

Date of registration:

9 November 2020

Product registration no.:

88958

Label approval no.:

88958/123025

Application no.:

127302

Product name:

Retacel 720 Plant Growth Regulant

Active constituent/s:

558 g/L chlormequat present as chlormequat chloride

Applicant name:

Draslovka Services Pty Ltd

Applicant ACN:

609 536 763

Summary of use:

For use as an aid in increasing grain yield and prevention of lodging in wheat

Date of registration:

11 November 2020

Product registration no.:

90074

Label approval no.:

90074/127302

Application no.:

123588

Product name:

Coromandel Fipronil 800 WG Insecticide

Active constituent/s:

800 g/kg fipronil

Applicant name:

Sabero Australia Pty Ltd

Applicant ACN:

087 313 059

Summary of use:

For the control of various insect pests in bananas, brassicas, cotton, wine grapes, mushrooms, pasture, potatoes, sorghum and sugarcane

Date of registration:

11 November 2020

Product registration no.:

89099

Label approval no.:

89099/123588

Application no.:

127313

Product name:

eChem e-Grex Selective Herbicide

Active constituent/s:

250 g/L MCPA present as the ethyl hexyl ester, 25 g/L diflufenican

Applicant name:

Echem (Aust) Pty Ltd

Applicant ACN:

089 133 095

Summary of use:

For the control of certain broadleaf weeds in winter cereals and clover

Date of registration:

12 November 2020

Product registration no.:

90077

Label approval no.:

90077/127313

Application no.:

122770

Product name:

JURA Herbicide

Active constituent/s:

667 g/L prosulfocarb, 14 g/L diflufenican

Applicant name:

Globachem N.V.

Applicant ACN:

N/A

Summary of use:

For control of annual rye grass in wheat and barley

Date of registration:

12 November 2020

Product registration no.:

88895

Label approval no.:

88895/122770

Application no.:

127314

Product name:

eChem Lambda 250 CS Insecticide

Active constituent/s:

250 g/L lambda-cyhalothrin

Applicant name:

eChem (Aust) Pty Ltd

Applicant ACN:

089 133 095

Summary of use:

For the control of certain insect pests in cotton, barley, wheat and various field crops

Date of registration:

12 November 2020

Product registration no.:

90078

Label approval no.:

90078/127314

Application no.:

124958

Product name:

Wynsate PRO 480 DMA Herbicide

Active constituent/s:

480 g/L glyphosate present as the dimethylammonium salt

Applicant name:

Zhejiang Xinan Chemical Industrial Group Co Ltd

Applicant ACN:

N/A

Summary of use:

For non-selective control of many annual and perennial weeds in conservation tillage, pre- and post-harvest uses, agricultural and non-agricultural situations

Date of registration:

13 November 2020

Product registration no.:

89462

Label approval no.:

89462/124958

Application no.:

122013

Product name:

Protim Optimum PTB Concentrate

Active constituent/s:

180 g/L tebuconazole, 180 g/L propiconazole, 34 g/L bifenthrin

Applicant name:

Koppers Performance Chemicals Australia Pty Ltd

Applicant ACN:

088 260 575

Summary of use:

For the protection of softwood and hardwood timber in hazard level H3 (outside and above ground) situations

Date of registration:

13 November 2020

Product registration no.:

88698

Label approval no.:

88698/122013

Application no.:

127104

Product name:

Hemani Jolt 800 EC Herbicide

Active constituent/s:

800 g/L prosulfocarb

Applicant name:

Hemani Industries Limited

Applicant ACN:

N/A

Summary of use:

For the control of annual ryegrass (Lolium rigidum) and other grass and broadleaf weeds in barley and wheat

Date of registration:

17 November 2020

Product registration no.:

90031

Label approval no.:

90031/127104

Application no.:

127338

Product name:

Sinon Pardnar 600 Herbicide

Active constituent/s:

600 g/kg metsulfuron-methyl

Applicant name:

Sinon Australia Pty Ltd

Applicant ACN:

102 741 024

Summary of use:

For the control of brush and broadleaf weeds in native pastures, rights of way, commercial and industrial areas, for the control of certain broadleaf weeds in winter cereal crops and for pre-harvest desiccation in mung beans

Date of registration:

19 November 2020

Product registration no.:

90086

Label approval no.:

90086/127338

Variations of registration

Application no.:

126307

Product name:

Rainbow Glufosinate 200 Herbicide

Active constituent/s:

200 g/L glufosinate-ammonium

Applicant name:

Shandong Rainbow International Co Ltd

Applicant ACN:

N/A

Summary of variation:

To add uses in turf, summer fallow situations (cereal grains, pulses and oilseeds), commercial and industrial areas, forest plantations, rights-of-way and other non-agricultural areas

Date of variation:

8 October 2020

Product registration no.:

66593

Label approval no.:

66593/126307

Application no.:

128437

Product name:

Kermit Bio 360 Herbicide

Active constituent/s:

360 g/L glyphosate present as the isopropylamine salt

Applicant name:

Crop Culture Pty Ltd

Applicant ACN:

142 860 473

Summary of variation:

To vary the distinguishing product name and the name that appears on the label from ‘Kermit 360 Herbicide’ to ‘Kermit Bio 360 Herbicide’

Date of variation:

26 October 2020

Product registration no.:

63601

Label approval no.:

63601/128437

Application no.:

128424

Product name:

Kermit Bio 510 Herbicide

Active constituent/s:

510 g/L glyphosate present as the isopropylamine salt

Applicant name:

Crop Culture Pty Ltd

Applicant ACN:

142 860 473

Summary of variation:

To vary the distinguishing product name and the name that appears on the label from ‘Kermit 510 Herbicide’ to ‘Kermit Bio 510 Herbicide’

Date of variation:

26 October 2020

Product registration no.:

64370

Label approval no.:

64370/128424

Application no.:

127111

Product name:

Accensi Oryzalin 500 Herbicide

Active constituent/s:

500 g/L oryzalin

Applicant name:

Accensi Pty Ltd

Applicant ACN:

079 875 184

Summary of variation:

To add use against broadleaf and grass weeds in ginger and duboisia

Date of variation:

28 October 2020

Product registration no.:

66403

Label approval no.:

66403/127111

Application no.:

128499

Product name:

Pooled Energy Bromide Up

Active constituent/s:

995 g/kg sodium bromide

Applicant name:

Pooled Energy Pty Ltd

Applicant ACN:

163 873 078

Summary of variation:

To vary the distinguishing product name and the name that appears on the label from ‘Pooled Energy Pool Sanitizer Precursor’ to ‘Pooled Energy Bromide Up’

Date of variation:

28 October 2020

Product registration no.:

87474

Label approval no.:

87474/128499

Application no.:

128519

Product name:

ProGuard Granular Pool Sanitiser

Active constituent/s:

660 g/kg chlorine present as trichloroisocyanuric acid

Applicant name:

Biolab Australia Pty Ltd

Applicant ACN:

005 878 017

Summary of variation:

To vary the distinguishing product name and the name that appears on the label from ‘Proguard Trichlor Plus Granules Pool Sanitiser’ to ‘Proguard Granular Pool Sanitiser’

Date of variation:

30 October 2020

Product registration no.:

66471

Label approval no.:

66471/128519

Application no.:

128594

Product name:

Barmac Trifluralin 480 Herbicide

Active constituent/s:

480 g/L trifluralin

Applicant name:

Amgrow Pty Ltd

Applicant ACN:

100 684 786

Summary of variation:

To vary the distinguishing product name and the name that appears on the label from ‘Barmac Tri-Max 480 Herbicide’ to ‘Barmac Trifluralin 480 Herbicide’

Date of variation:

6 November 2020

Product registration no.:

88601

Label approval no.:

88601/128594

Application no.:

121545

Product name:

Skope Insecticide

Active constituent/s:

218 g/L acetamiprid, 32.5 g/L emamectin present as emamectin benzoate

Applicant name:

ADAMA Australia Pty Ltd

Applicant ACN:

050 328 973

Summary of variation:

To extend use to include control of various pests in pulses and control of jassids and two-spotted mite in cotton

Date of variation:

9 November 2020

Product registration no.:

81486

Label approval no.:

81486/121545

Application no.:

127198

Product name:

Accensi Metolachlor 960 Herbicide

Active constituent/s:

960 g/L metolachlor

Applicant name:

Accensi Pty Ltd

Applicant ACN:

079 875 184

Summary of variation:

To add the instructions for multiple pests in mustard, various broadleaf and grass weeds in spinach, silverbeet, spring onions, shallots, green beans and navy beans and certain annual grasses and broadleaf weeds in adzuki beans and mung beans

Date of variation:

9 November 2020

Product registration no.:

67083

Label approval no.:

67083/127198

Application no.:

126643

Product name:

Family Protection Aerogard Body Odourless Protection 6 Hours Protection Low Irritant* Great For Kids 12 Months+ Insect Repellent Spray

Active constituent/s:

92.8 g/L picaridin

Applicant name:

RB (Hygiene Home) Australia Pty Ltd

Applicant ACN:

629 549 506

Summary of variation:

To change product name, expand registered pack sizes, add additional manufacturing sites and amend approved label

Date of variation:

9 November 2020

Product registration no.:

61365

Label approval no.:

61365/126643

Application no.:

125824

Product name:

Oskar 540 Herbicide

Active constituent/s:

540 g/L glyphosate present as the potassium salt

Applicant name:

Crop Culture Pty Ltd

Applicant ACN:

142 860 473

Summary of variation:

To add additional situations including control of various weeds in pasture

Date of variation:

10 November 2020

Product registration no.:

85145

Label approval no.:

85145/125824

Application no.:

127275

Product name:

Imtrade Simazine 900 WG Herbicide

Active constituent/s:

900 g/kg simazine

Applicant name:

Imtrade Australia Pty Ltd

Applicant ACN:

090 151 134

Summary of variation:

To add the following uses under the Permit to Label Project: broadleaf weeds and grasses in almonds, various pests in pyrethrum crops, weed control in walnuts, specified grass and broadleaf weeds in leeks, various pests and diseases in tea tree oil, broadleaf and grass weeds in ginger (Zingiber officinale), weed and sucker control in hazel nuts, various weeds in nursery stock (non-food), foliage, cut flowers and wildflowers

Date of variation:

10 November 2020

Product registration no.:

63660

Label approval no.:

63660/127275

Application no.:

127180

Product name:

Chemag Thor 250EC Herbicide

Active constituent/s:

125 g/L oryzalin, 125 g/L trifluralin

Applicant name:

Imtrade Australia Pty Ltd

Applicant ACN:

090 151 134

Summary of variation:

To add a use for the control of weeds in mustard

Date of variation:

11 November 2020

Product registration no.:

60141

Label approval no.:

60141/127180

Application no.:

127107

Product name:

Trelona Termite Bait

Active constituent/s:

5 g/kg novaluron

Applicant name:

BASF Australia Ltd

Applicant ACN:

008 437 867

Summary of variation:

To include use in above ground baiting stations for the control of subterranean termites and the protection of structures

Date of variation:

11 November 2020

Product registration no.:

86731

Label approval no.:

86731/127107

Application no.:

127298

Product name:

Imtrade Tebuconazole 430 SC Fungicide

Active constituent/s:

430 g/L tebuconazole

Applicant name:

Imtrade Australia Pty Ltd

Applicant ACN:

090 151 134

Summary of variation:

To add the following use instructions: duboisia, anise myrtle, lemon myrtle, oil tea tree, beetroot, beetroot leaves, carrots, chicory, endive, radish, silverbeet, spinach, mung beans, faba beans, broad beans, soya beans, garlic, walnuts and non-food producing plants including nursery stock

Date of variation:

11 November 2020

Product registration no.:

63454

Label approval no.:

63454/127298

Application no.:

126672

Product name:

Nufarm Avadex Xtra Selective Herbicide

Active constituent/s:

500 g/L triallate

Applicant name:

Nufarm Australia Limited

Applicant ACN:

004 377 780

Summary of variation:

To add a new use in wheat and to add uses under the Permit to Label Project

Date of variation:

12 November 2020

Product registration no.:

56598

Label approval no.:

56598/126672

Application no.:

126178

Product name:

Timbertreat A Azole Insecticide/Fungicide Wood Preservative

Active constituent/s:

125 g/L propiconazole, 125 g/L tebuconazole, 83 g/L permethrin

Applicant name:

Kop-Coat Australia Pty Ltd

Applicant ACN:

088 537 473

Summary of variation:

To add uses for the treatment of eucalyptus nitens timber decking using a spray flood coating system

Date of variation:

13 November 2020

Product registration no.:

69683

Label approval no.:

69683/126178

Application no.:

125914

Product name:

Conquest Tricon Flexi 480 Selective Herbicide

Active constituent/s:

480 g/L trifluralin

Applicant name:

Conquest Crop Protection Pty Ltd

Applicant ACN:

098 814 932

Summary of variation:

To add uses in legumes, oilseeds, peppers and eggplant, quinoa, parsnips, swede, turnip, duboisia and industrial hemp

Date of variation:

17 November 2020

Product registration no.:

60603

Label approval no.:

60603/125914

Application no.:

127205

Product name:

Conquest Triagra 500 EC Selective Herbicide

Active constituent/s:

500 g/L triallate

Applicant name:

Conquest Crop Protection Pty Ltd

Applicant ACN:

098 814 932

Summary of variation:

To add new uses for control of grasses and broadleaf weeds in wheat, barley, triticale and canola

Date of variation:

17 November 2020

Product registration no.:

65419

Label approval no.:

65419/127205

Application no.:

126181

Product name:

Biotrap DDVP Cubes

Active constituent/s:

186 g/kg dichlorvos (an anticholinesterase compound)

Applicant name:

Bio-trap Australia Pty Ltd

Applicant ACN:

127 689 507

Summary of variation:

To extend the use of the product to monitor/control insects more broadly in commercial orchards and other horticultural crops

Date of variation:

18 November 2020

Product registration no.:

68989

Label approval no.:

68989/126181

Application no.:

127271

Product name:

Apparent Expunge 600 FS Insecticide

Active constituent/s:

600 g/L imidacloprid

Applicant name:

Titan Ag Pty Ltd

Applicant ACN:

122 081 574

Summary of variation:

To amend the formulation type of the product and update the product name to ‘Apparent Expunge 600 FS Insecticide’

Date of variation:

18 November 2020

Product registration no.:

68402

Label approval no.:

68402/127271

Application no.:

127394

Product name:

Imtrade Metal Gold 960 EC Herbicide

Active constituent/s:

960 g/L S-Metolachlor

Applicant name:

Imtrade Australia Pty Ltd

Applicant ACN:

090 151 134

Summary of variation:

To add the control of various weeds in rhubarb, various broadleaf and grass weeds in brassica leafy vegetables, multiple pests in mustard, various broadleaf and grass weeds in spinach, silverbeet, spring onions, shallots, green beans and navy beans and various weeds in culinary herbs

Date of variation:

18 November 2020

Product registration no.:

69336

Label approval no.:

69336/127394

Application no.:

126557

Product name:

Agri-Fos 600 Systemic Fungicide

Active constituent/s:

600 g/L phosphorous (phosphonic) acid as mono-di k phosphonate

Applicant name:

Liquid Fertiliser Pty Ltd

Applicant ACN:

105 456 148

Summary of variation:

To shorten the withholding period for macadamias from 28 days to 14 days

Date of variation:

18 November 2020

Product registration no.:

54430

Label approval no.:

54430/126557

Application no.:

127320

Product name:

Amgrow Chemspray Weed Control Tree & Blackberry Killer

Active constituent/s:

50 g/L triclopyr present as the butoxyethyl ester

Applicant name:

Amgrow Pty Ltd

Applicant ACN:

100 684 786

Summary of variation:

To include additional pack sizes

Date of variation:

19 November 2020

Product registration no.:

59002

Label approval no.:

59002/127320

Application no.:

127395

Product name:

Imtrade Metal Plus 960 EC Herbicide

Active constituent/s:

960 g/L metolachlor

Applicant name:

Imtrade Australia Pty Ltd

Applicant ACN:

090 151 134

Summary of variation:

To add uses for multiple pests in mustard, various broadleaf and grass weeds in spinach, silverbeet, spring onions, shallots, green beans and navy beans, certain annual grasses and broadleaf weeds in adzuki beans and mung beans

Date of variation:

20 November 2020

Product registration no.:

66486

Label approval no.:

66486/127395

Application no.:

127418

Product name:

Surefire Tusk Fungicide

Active constituent/s:

430 g/L tebuconazole

Applicant name:

PCT Holdings Pty Ltd

Applicant ACN:

099 023 962

Summary of variation:

To add uses in duboisia, oil tea tree, anise myrtle, lemon myrtle, non-food producing plants and vegetation, beetroot, beetroot leaves, chicory, endive, radish, silverbeet, spinach, carrots, mung beans, faba beans, broad beans, soya beans, walnuts and garlic

Date of variation:

20 November 2020

Product registration no.:

84325

Label approval no.:

84325/127418

Application no.:

127399

Product name:

Sinker Fungicide

Active constituent/s:

500 g/L flutriafol

Applicant name:

Nufarm Australia Limited

Applicant ACN:

004 377 780

Summary of variation:

To update first aid instructions and storage and disposal directions

Date of variation:

20 November 2020

Product registration no.:

67732

Label approval no.:

67732/127399

variation of label approval

Application no.:

127170

Product name:

Chippolay Selective Herbicide

Active constituent/s:

700 g/kg methabenzthiazuron

Applicant name:

Agnova Technologies Pty Ltd

Applicant ACN:

097 705 158

Summary of variation:

To delete a maximum rate on the product label and add a recommendation to tank mix

Date of variation:

17 November 2020

Product registration no.:

86507

Label approval no.:

86507/127170

Commonwealth of Australia Gazette

No. APVMA 24, Tuesday, 1 December 2020Agricultural and Veterinary Chemicals Code Act 199413

Agricultural 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.:

125868

Product name:

Cura-Linc 790 g/kg Antibiotic Soluble Powder

Active constituent/s:

1,000 g/kg lincomycin hydrochloride equivalent to not less than 790 g/kg lincomycin base

Applicant name:

Probus Pharmaceuticals Pty Ltd

Applicant ACN:

638 193 674

Summary of use:

For treatment of swine dysentery caused by Serpulina hyodysenteriae in pigs

Date of registration:

11 November 2020

Product registration no.:

89713

Label approval no.:

89713/125868

Application no.:

125896

Product name:

Di-Fly Extra Spray-On Blowfly Treatment For Sheep

Active constituent/s:

65 g/L dicyclanil

Applicant name:

Abbey Laboratories Pty Ltd

Applicant ACN:

156 000 430

Summary of use:

For the protection of sheep against fly strike and the protection of mulesing and marking wounds on sheep against fly strike during the wound healing process

Date of registration:

13 November 2020

Product registration no.:

89723

Label approval no.:

89723/125896

Application no.:

107550

Product name:

Vanguard Intranasal Resp 3 Live Vaccine For Dogs

Active constituent/s:

Each dose contains live attenuated: Canine Adenovirus Type 2 (≥10^3.1 TCID50), Canine Parainfluenza Virus (≥10^5.0 TCID50), Bordetella bronchiseptica (≥1.3 x 10^6 CFU)

Applicant name:

Zoetis Australia Pty Ltd

Applicant ACN:

156 476 425

Summary of use:

For the active immunisation of healthy dogs and puppies from 8 weeks of age to reduce clinical signs associated with respiratory tract disease and shedding induced by Bordetella bronchiseptica, Canine Parainfluenza Virus (CPI) and Canine Adenovirus Type 2 (CAV-2)

Date of registration:

13 November 2020

Product registration no.:

83109

Label approval no.:

83109/107550

Application no.:

126018

Product name:

Kefvet Oral Antibiotic Drops For Dogs And Cats

Active constituent/s:

150 mg/g cephalexin

Applicant name:

Bocko P/L & Flexsky P/L In Partnership

Applicant ABN:

57 147 389 678

Summary of use:

For treatment of susceptible infections of the respiratory tract, urogenital tract, the skin and localised infections in soft tissues of dogs and cats

Date of registration:

13 November 2020

Product registration no.:

89760

Label approval no.:

89760/126018

Variations of registration

Application no.:

128488

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 vary the distinguishing product name and the name that appears on the label from ‘I-Mec Premix For Pigs’ to ‘ZeroMec Premix For Pigs’

Date of variation:

28 October 2020

Product registration no.:

87145

Label approval no.:

87145 / 128488

Application no:

126120

Product name:

Equine Joint Support Formula 2

Active constituent/s:

200 g/kg glucosamine sulphate (marine exoskeleton), 60 g/kg sodium chondroitin sulphate (bovine cartilage)

Applicant name:

International Animal Health Products Pty Ltd

Applicant ACN:

003 185 699

Summary of variation:

To vary the claim statement and to add 2 pack sizes

Date of variation:

10 November 2020

Product registration no.:

64740

Label approval no.:

64740/126120

Application no:

127060

Product name:

Milbemax Tablets for Small Cats

Active constituent/s:

10 mg/tb praziquantel, 4 mg/tb milbemycin oxime

Applicant name:

Elanco Australasia Pty Ltd

Applicant ACN:

076 745 198

Summary of variation:

To update the wording of the approved label

Date of variation:

11 November 2020

Product registration no.:

54264

Label approval no.:

54264/127060

Application no.:

127061

Product name:

Milbemax Tablets for Cats

Active constituent/s:

40 mg/tb praziquantel, 16 mg/tb milbemycin oxime

Applicant name:

Elanco Australasia Pty Ltd

Applicant ACN:

076 745 198

Summary of variation:

To update the wording of the approved label

Date of variation:

11 November 2020

Product registration no.:

54265

Label approval no.:

54265/127061

Application no.:

125961

Product name:

Clomav 80mg Tablets

Active constituent/s:

80 mg/tb clomipramine hydrochloride equivalent to 72 mg clomipramine

Applicant name:

Mavlab Pty Ltd

Applicant ACN:

009 708 187

Summary of variation:

To add 2 additional pack sizes

Date of variation:

16 November 2020

Product registration no.:

63990

Label approval no.:

63990/125961

Application no.:

125962

Product name:

Clomav 20mg Tablets

Active constituent/s:

20 mg/tb clomipramine hydrochloride equivalent to 18 mg clomipramine

Applicant name:

Mavlab Pty Ltd

Applicant ACN:

009 708 187

Summary of variation:

To add 2 additional pack sizes

Date of variation:

16 November 2020

Product registration no.:

63991

Label approval no.:

63991/125962

Application no.:

125963

Product name:

Clomav 5mg Tablets

Active constituent/s:

5 mg/tb clomipramine hydrochloride equivalent to 4.5 mg clomipramine

Applicant name:

Mavlab Pty Ltd

Applicant ACN:

009 708 187

Summary of variation:

To add 2 additional pack sizes

Date of variation:

16 November 2020

Product registration no.:

63992

Label approval no.:

63992/125963

Application no:

127341

Product name:

Troy Behave Equine – Tryptophan and Vitamin Supplement Paste

Active constituent/s:

333 mg/mL L-tryptophan

Applicant name:

Troy Laboratories Pty Ltd

Applicant ACN:

000 283 769

Summary of variation:

To add a new pack size

Date of variation:

18 November 2020

Product registration no.:

62502

Label approval no.:

62502/127341

Commonwealth of Australia Gazette

No. APVMA 24, Tuesday, 1 December 2020Agricultural and Veterinary Chemicals Code Act 199428

Commonwealth of Australia Gazette

No. APVMA 24, Tuesday, 1 December 2020Agricultural and Veterinary Chemicals Code Act 199416

Veterinary Chemical Products and Approved Labels

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.:

124939

Active constituent/s:

Clothianidin

Applicant name:

BASF Australia Ltd

Applicant ACN:

008 437 867

Summary of use:

For use in agricultural chemical products

Date of approval:

10 November 2020

Approval no.:

89452

Application no.:

124785

Active constituent/s:

Clothianidin

Applicant name:

BASF Australia Ltd

Applicant ACN:

008 437 867

Summary of use:

For use in agricultural chemical products

Date of approval:

10 November 2020

Approval no.:

89418

Application no.:

123631

Active constituent/s:

2,4-D 2-ethylhexyl ester

Applicant name:

Kenso Corporation (M) Sdn Bhd

Applicant ACN:

N/A

Summary of use:

For use in agricultural chemical products

Date of approval:

11 November 2020

Approval no.:

89105

Application no.:

123077

Active constituent/s:

2,4-D isobutyl ester

Applicant name:

4 Farmers Australia Pty Ltd

Applicant ACN:

160 092 428

Summary of use:

For use in agricultural chemical products

Date of approval:

12 November 2020

Approval no.:

88976

Application no.:

126036

Active constituent/s:

Maropitant citrate

Applicant name:

Zoetis Australia Ltd

Applicant ACN:

156 476 425

Summary of use:

For use in veterinary chemical products

Date of approval:

13 November 2020

Approval no.:

89769

Application no.:

123193

Active constituent/s:

2,4-D-2-ethylhexyl ester

Applicant name:

Niensis Pty Ltd

Applicant ACN:

633 476 892

Summary of use:

For use in agricultural chemical products

Date of approval:

13 November 2020

Approval no.:

89021

Application no.:

107559

Active constituent/s:

Bordetella bronshiseptica

Applicant name:

Zoetis Australia Pty Ltd

Applicant ACN:

156 476 425

Summary of use:

For use in veterinary chemical products

Date of approval:

13 November 2020

Approval no.:

83114

Application no.:

125093

Active constituent/s:

Fluazifop-P-butyl

Applicant name:

Shandong Binnong Technology Co Ltd

Applicant ACN:

N/A

Summary of use:

For use in agricultural chemical products

Date of approval:

18 November 2020

Approval no.:

89506

Application no.:

125134

Active constituent/s:

Abamectin

Applicant name:

Shanghai E-Tong Chemical Co Ltd

Applicant ACN:

N/A

Summary of use:

For use in agricultural chemical products

Date of approval:

18 November 2020

Approval no.:

89524

Commonwealth of Australia Gazette

No. APVMA 24, Tuesday, 1 December 2020Agricultural and Veterinary Chemicals Code Act 199418

Approved Active Constituents

New Agricultural Active Constituent: Acequinocyl

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new active constituent, acequinocyl, for use in the control of all immature life stages of spider mites in greenhouses and shade houses on container-grown ornamental, floral, foliage and nursery crops as well as on field-grown ornamentals and pome fruit using ground application equipment.

Particulars of the Active Constituent

Common name:

Acequinocyl

IUPAC name:

3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate

CAS name:

2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione

CAS registry number:

57960-19-7

Minimum purity:

960 g/kg

Molecular formula:

C24H32O4

Molecular weight:

384.5 gmol-1

Structure:

Chemical family:

1,4-naphthoquinone

Summary of the APVMA’s Evaluation of ACEQUINOCYL Active Constituent

The APVMA has evaluated the chemistry aspects of active constituent acequinocyl (physico-chemical properties, identification, spectra, manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.

The APVMA has considered the toxicological aspects of acequinocyl, and concluded that there are no toxicological concerns regarding the approval of this active constituent. An acceptable daily intake (ADI) for acequinocyl was established at 0.023 mg/kg bw/day, while an acute reference dose (ARfD) was established at 0.08 mg/kg bw. No toxicologically significant impurities have been identified in acequinocyl technical active constituent.

The Scheduling Delegate made a final decision to included acequinocyl in Schedule 5 of the SUSMP with no cut-off or exemption, and with effect from 1 June 2020.

On the basis of the data provided, and the toxicological assessment, it is proposed that the following active constituent standard be established for acequinocyl:

Constituent

Level

Acequinocyl

Minimum purity 960 g/kg

Other compounds of toxicological significance are not expected to occur in acequinocyl as a result of the raw materials and the synthetic route used.

The APVMA is satisfied that the proposed importation and use of acequinocyl would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use.

FuRther Information

A Public Release Summary (PRS) of the evaluations of the active and the associated product is available from the APVMA website’s ‘Public Consultation’ page.

Making a Submission

In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for approval of acequinocyl 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.

Please note: Submissions will be published on the APVMA’s website, unless you have asked for the submission to remain confidential (see public submission coversheet).

Please lodge your submission with a public submission 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.

Please send your written submission and coversheet by email or post to:

Email: [email protected]

Post:

Director of Chemistry and Manufacture

Risk Assessment Capability

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Commonwealth of Australia Gazette

No. APVMA 24, Tuesday, 1 December 2020Agricultural and Veterinary Chemicals Code Act 199419

Sydney NSW 2001

New Agricultural Active Constituent: Acequinocyl

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. 10) 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

Commonwealth of Australia Gazette

No. APVMA 24, Tuesday, 1 December 2020Agricultural and Veterinary Chemicals Code Act 199421

Email:[email protected]

Amendments to the APVMA MRL Standard

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

In the previous notice on page 21 of APVMA Gazette No. 24, 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. 10) 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.

PROPOSED VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE (1 December 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 from each of the following chemicals, the foods and associated MRLs

Agvet chemical: acetamiprid

Permitted residue – commodities of plant origin: acetamiprid

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

Avocado

0.05

Mango

0.05

Agvet chemical: cyproconazole

Permitted residue – cyproconazole, sum of isomers

Chick-pea (dry)

0.03

Lentil (dry)

0.03

Agvet chemical: pyriproxyfen

Permitted residue – pyriproxyfen

Avocado

0.05

Mango

0.05

Olives

1

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

Agvet chemical: acetamiprid

Permitted residue – commodities of plant origin: acetamiprid

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

Assorted tropical and sub-tropical fruits – inedible peel

0.2

Olives for oil production

T0.5

Persimmon, Japanese

T0.3

Table olives

T0.5

Agvet chemical: afidopyropen

Permitted residue – commodities of plant origin: afidopyropen

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

Artichoke, globe

0.1

Barley

*0.01

Rape seed [canola]

*0.01

Rhubarb

0.1

Sweet corn (corn-on-the-cob)

*0.01

Wheat

*0.01

Agvet chemical: cyproconazole

Permitted residue – cyproconazole, sum of isomers

Pulses

0.05

Sweet corn (corn-on-the-cob)

*0.01

Agvet chemical: flumioxazin

Permitted residue – flumioxazin

Banana

T*0.02

Agvet chemical: pyriproxyfen

Permitted residue – pyriproxyfen

Assorted tropical and sub-tropical fruits – inedible peel

0.3

Olives for oil production

1

Persimmon, Japanese

T0.2

Table olives

1

Agvet chemical: tetraniliprole

Permitted residue – tetraniliprole

All other foods except animal commodities

0.02

Mango

T0.2

Meat (mammalian)

*0.01

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

Agvet chemical: afidopyropen

Permitted residue – commodities of plant origin: Afidopyropen

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

Carrot

*0.01

Strawberry

0.2

Agvet chemical: azoxystrobin

Permitted residue – azoxystrobin

Maize

*0.01

Agvet chemical: cyproconazole

Permitted residue – cyproconazole, sum of isomers

Maize

*0.01

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 (AEDT) 4 January 2021

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.

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 2401

Commonwealth of Australia Gazette

No. APVMA 24, Tuesday, 1 December 2020Agricultural and Veterinary Chemicals Code Act 199426

Email:[email protected]

Proposal to amend Schedule 20 in 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. 7) gazetted on 8 September 2020 (No. APVMA 18).

Submissions have been sought on these proposals and the APVMA has written separately to each person or organisation that made a submission. All matters raised in the submissions have been resolved.

Under subsection 82(1) of the Food Standards Australia New Zealand Act 1991, the APVMA has, by legislative instrument, incorporated these variations to MRLs into Schedule 20. A copy of the Amendment Instrument (No. APVMA 10, 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.

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

Commonwealth of Australia Gazette

No. APVMA 24, Tuesday, 1 December 2020Agricultural and Veterinary Chemicals Code Act 199429

Email:[email protected]

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

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

Australia New Zealand Food Standards Code – Schedule 20 – Maximum residue limits Variation InstrumentNo. APVMA 9, 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 Twenty Fourth day of November 2020

Part 1Preliminary

1Name of instrument

This instrument is the Australia New Zealand Food Standards Code – Schedule 20 Maximum residue limits Variation Instrument No. APVMA 9. 2020 (Amendment Instrument).

2Commencement

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.

3Object

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

4Interpretation

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 2Variations to Schedule 20 – Maximum residue limits

5Variations to Schedule 20

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

Schedule

Variations to Schedule 20 – Maximum residue limits

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

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

Agvet chemical: metribuzin

Permitted residue – metribuzin

Root and tuber vegetables [except carrot; potato]

T*0.05

Agvet chemical: pyraflufen-ethyl

Permitted residue – sum of pyraflufen-ethyl and its acid metabolite (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxyacetic acid)

Broad bean (dry) (fava bean)

*0.02

Field bean (dry)

*0.02

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

Cereal grains

0.2

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

Agvet chemical: imidacloprid

Permitted residue – sum of imidacloprid and metabolites containing the 6-chloropyridinylmethylene moiety, expressed as imidacloprid

Galangal, lesser

T0.05

Ginger, Japanese

T0.05

Agvet chemical: pyraflufen-ethyl

Permitted residue – sum of pyraflufen-ethyl and its acid metabolite (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxyacetic acid)

Pulses

*0.02

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

Cereal grains (except rice)

0.2

Rice

*0.01

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

Agvet chemical: clothianidin

Permitted residue: clothianidin

see also thiamethoxam

Almonds

0.05

Agvet chemical: fluralaner

Permitted residue – fluralaner

Cattle fat

T0.7

Cattle kidney

T0.25

Cattle liver

T0.6

Cattle muscle

T0.07

Agvet chemical: metribuzin

Permitted residue – metribuzin

Ginger root

T*0.01

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

Stop Supply: Fleamail Pty Ltd (ACN 637 942 128)

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. 23 of 2020

On 24 November 2020, the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to Fleamail Pty Ltd ACN 637 942 128 (‘the Company’), pursuant to section 103 of the Agvet Code in relation to the registered chemical products set out in the Schedule below (‘the Products’).

This notice required the Company to immediately not supply, or stop supplying, to any person, stocks of the Products which do not have an Approved Label.

Products with an APVMA approved label are not affected by this notice.

COMPANY Details

Fleamail Pty Ltd ACN 637 942 128

Level 3, 155 Queen Street

Brisbane City QLD 4000

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 2304

Email:[email protected]

SCHEDULE OF PRODUCTS

Product name

APVMA approval number

Simparica Chews for Dogs 1.3 – 2.5 kg

80951

Simparica Chews for Dogs 2.6 – 5 kg

80950

Simparica Chews for Dogs 5.1 – 10 kg

80949

Simparica Chews for Dogs 10.1 – 20 kg

80948

Simparica Chews for Dogs 20.1 – 40 kg

80945

Simparica Chews for Dogs 40.1 – 60 kg

80943

Valuheart Monthly Heartworm Tablets for Small Dogs

66289

Valuheart Monthly Heartworm Tablets for Large Dogs

66288

Valuheart Monthly Heartworm Tablets for Medium Dogs

66287

Cazitel Flavoured Allwormer Tablets for Dogs

66818

Cazitel Flavoured Allwormer Tablets for Large Dogs

66816

Revolution for Puppies And Kittens

50867

Revolution for Cats

50881

Revolution Plus (selamectin/sarolaner) monthly topical solution for large cats 5.1 – 10 kg

87222

Revolution Plus (selamectin/sarolaner) monthly topical solution for medium cats 2.6 – 5 kg

87224

Revolution Plus (selamectin/sarolaner) monthly topical solution for small cats and kittens 1.25 – 2.5 kg

87225

Advocate for Kittens and Small Cats up to 4 kg

55325

Advocate for Cats Over 4 kg

55326

Commonwealth of Australia Gazette

No. APVMA 24, Tuesday, 1 December 2020Agricultural and Veterinary Chemicals Code Act 199433

Stop Supply: Fleamail Pty Ltd (ACN 637 942 128)

Stop Supply: Ausrichter Pty Ltd (ACN 000 908 529)

Notice under section 102 of the AGRICULTURAL AND VETERINARY CHEMICALS CODE SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994 (CTH) (Agvet Code) – No. 24 of 2020

On 20 November 2020, the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to Ausrichter Pty Ltd (ACN 000 908 529) (‘the Company’), pursuant to section 102 of the Agvet Code in relation to the registered chemical product labelled or known as Equisedan Vet 10 mg/ml Solution for injection (APVMA 61880/10 ml/109), labelled or known as batch 5823-04.

This notice required the Company to immediately stop supply of all stocks of batch 5823-04 of Equisedan Vet 10 mg/ml Solution for injection; to immediately notify any person who has possession or custody of stocks of batch 5823-04 of Equisedan Vet 10 mg/ml Solution for injection (either directly or indirectly because of a supply by the Company) that they must stop supply of stocks of batch 5823-04 of Equisedan Vet 10 mg/ml Solution for injection and return it to the Company immediately; take all necessary steps to recover all stocks of batch 5823-04 of Equisedan Vet 10 mg/ml Solution for injection from any person to whom the Company has either directly or indirectly supplied batch 5823-04 of Equisedan Vet 10 mg/ml Solution for injection; appropriately test any recovered units of batch 5823-04 of the product Equisedan Vet 10 mg/ml Solution for injection to ensure that they meet the safety, trade and efficacy criteria before resupply; and quarantine or destroy any defective units of batch 5823-04 of Equisedan Vet 10 mg/ml Solution for injection in the possession or custody of, or recovered by, the Company.

Supplier Details

Ausrichter Pty Ltd (ACN 000 908 529)

Unit 2/21 Chester Street

Camperdown NSW 2050

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 2304

Email:[email protected]


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