APVMA Gazette No. 14, 11 July 2017...2017/07/11 · No. APVMA 14, Tuesday, 11 July 2017 Published by The Australian Pesticides and Veterinary Medicines Authority AGRICULTURAL AND

No. APVMA 14, Tuesday, 11 July 2017 Published by The Australian Pesticides and Veterinary Medicines Authority

AGRICULTURAL AND VETERINARY CHEMICALS

The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be published in the Gazette containing details of the registration of agricultural and veterinary chemical products and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.

ISSN 1837 - 7629

Commonwealth of Australia Gazette No. APVMA 14, Tuesday, 11 July 2017 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2017

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

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

inquiries concerning reproduction and rights should be addressed to:

Director, Public Affairs and Communications

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

Kingston ACT 2604

Email: [email protected]

Website: www.apvma.gov.au.

GENERAL INFORMATION

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

the registration of agricultural and veterinary chemicals products and other approvals granted by the 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.

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CONTENTS

Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and Approved Labels ...................................................................................................... 9 Approved Active Constituents ....................................................................................................................................... 10 Approved Active Constituents—s14 .............................................................................................................................. 11 Approved Active Constituents—s14A............................................................................................................................ 12 Amendments to the APVMA MRL Standard .................................................................................................................. 30 Proposal to Amend Schedule 20 in the Australia New Zealand Food Standards Code ................................................ 31 Variations to Schedule 20 of the Australia New Zealand Food Standards Code ........................................................... 35 Cancellation of Product Label Approval at the Request of the Holder ........................................................................... 40


Agricultural Chemical Products and Approved Labels

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Application no.: 109472

Product name: Maxunitech Triclopyr 600 Herbicide Active constituent/s: 600 g/L triclopyr present as the butoxyethyl ester Applicant name: Max(Rudong) Chemicals Co., Ltd Applicant ACN: N/A Summary of use: For control of woody and broadleaf weeds as specified in the directions for use Date of registration/approval: 23 June 2017 Product registration no.: 83993 Label approval no.: 83993/109472


Product name: Ozcrop Ransake Herbicide Active constituent/s: 300 g/L triclopyr present as the butoxyethyl ester, 100 g/L picloram present as

hexyloxypropylamine salt Applicant name: Ozcrop Pty Ltd Applicant ACN: 160 656 431 Summary of use: For control of woody and herbaceous weeds Date of registration/approval: 26 June 2017 Product registration no.: 83991 Label approval no.: 83991/109469


Product name: Surefire Decree 520 EC Herbicide Active constituent/s: 520 g/L haloxyfop present as the haloxyfop-R-methyl ester Applicant name: PCT Holdings Pty Ltd Applicant ACN: 099 023 962 Summary of use: For the post-emergent control of annual and perennial grass weeds as specified in the

directions for use Date of registration/approval: 26 June 2017 Product registration no.: 83849 Label approval no.: 83849/109073


Product name: Hovex Extra Strength Multi Insect Automatic Spray Indoor & Outdoor Active constituent/s: 14 g/kg pyrethrins, 60 g/kg piperonyl butoxide

Applicant name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of use: For use in controlling insects around the home and garden Date of registration/approval: 27 June 2017 Product registration no.: 84326 Label approval no.: 84326/110111




Product name: Hovex Ant Spider & Cockroach Killer Concentrate Active constituent/s: 100 g/L permethrin 25:75 Applicant name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of use: For the control of insects around the home and garden Date of registration/approval: 28 June 2017 Product registration no.: 84420 Label approval no.: 84420/110352


Product name: Hovex Outback Fly & Mosquito Spray Active constituent/s: 1.1 g/kg esbiothrin, 0.5 g/kg permethrin Applicant name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of use: For the control of insects around the home Date of registration: 29 June 2017 Product registration no.: 84308 Label approval no.: 84308/110080

Application no.: 110078 Product name: Hovex Outback Insect Control Bomb Active constituent/s: 10.0 g/kg permethrin, 0.77 g/kg fenoxycarb Applicant name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of use: For the control of insects in domestic situations Date of registration: 29 June 2017 Product registration no.: 84306 Label approval no.: 84306/110078


Product name: Supa-Wet 1000 Agricultural Wetting Agent Active constituent/s: 1000 g/L alcohol alkoxylate Applicant name: Australian Adjuvants Pty Ltd Applicant ACN: 614 361 705 Summary of use: For use as a wetting agent to enhance herbicide activity Date of registration: 30 June 2017 Product registration no.: 84032 Label approval no.: 84032/109536


Product name: Drabant Fungicide Active constituent/s: 375 g/L fluazinam, 150 g/L azoxystrobin Applicant name: FMC Australasia Pty Ltd Applicant ACN: 110 199 169 Summary of use: For the control of early blight and late blight in potatoes Date of registration: 30 June 2017 Product registration no.: 80565 Label approval no.: 80565/101123




Product name: Scotts Lawn Builder Buffalo Weed, Feed & Green-Up Active constituent/s: 8.7 g/L bromoxynil present as the potassium salt, 8.7 g/L MCPA present as the

potassium salt Applicant name: Scotts Australia Pty Ltd Applicant ACN: 003 123 162 Summary of use: For the selective control of broadleaf weeds in domestic lawns Date of registration/approval: 3 July 2017 Product registration no.: 82584 Label approval no.: 82584/106131


Product name: Surefire Saxa 750 WG Herbicide Active constituent/s: 750 g/kg isoxaflutole Applicant name: PCT Holdings Pty Ltd Applicant ACN: 099 023 962 Summary of use: For the control of broadleaf weeds and grasses in sugarcane and chickpeas Date of registration: 3 July 2017 Product registration no.: 84233 Label approval no.: 84233/109923


Product name: Ozcrop Methomyl 225 SL Insecticide Active constituent/s: 225 g/L methomyl (an anti-cholinesterase compound) Applicant name: Ozcrop Pty Ltd Applicant ACN: 160 656 431 Summary of use: For the control of insect pests in various crops Date of registration/approval: 4 July 2017 Product registration no.: 84035 Label approval no.: 84035/109539

Application no.: 108975 Product name: Sharda Glufosinate 200 Herbicide Active constituent/s: 200 g/L glufosinate-ammonium Applicant name: Sharda Cropchem Espana S.L Applicant ACN: N/A Summary of use: For the non-residual control of broadleaf and grass weeds in various crop, orchard,

vineyard and plantation situations, and commercial, industrial, and other non-agricultural situations and line-marking situations

Date of registration/approval: 6 July 2017 Product registration no.: 83786 Label approval no.: 83786/108975



2. VARIATIONS OF REGISTRATION

Application no.: 109816 Product name: Macphersons Protea 800 EC Herbicide Active constituent/s: 800 g/L prosulfocarb Applicant name: TGAC Australia Pty Ltd Applicant ACN: 134 570 700 Summary of variation: To remove a use pattern and update plant back period for sensitive crops Date of variation: 26 June 2017 Product registration no.: 81295 Label approval no.: 81295/109816

Application no.: 108820 Product name: Kombo 950 Adjuvant Active constituent/s: 150 g/kg carboxylic acid, 800 g/kg ammonium sulphate Applicant name: BD Chemicals Pty Ltd Applicant ACN: 110 919 134 Summary of variation: To extend use to include use as spray drift mitigation agent and make recommendations

relating to temperature, water hardness and acidity Date of variation: 27 June 2017 Product registration no.: 67811 Label approval no.: 67811/108820

Application no.: 110327 Product name: Prolectus Fungicide Active constituent/s: 400 g/L fenpyrazamine Applicant name: Sumitomo Chemical Australia Pty Limited Applicant ACN: 081 096 255 Summary of variation: To modify the grazing withholding period Date of variation: 28 June 2017 Product registration no.: 68251 Label approval no.: 68251/110327

Application no.: 107475 Product name: Conquest Dargo 500 SC Selective Herbicide Active constituent/s: 500 g/L propyzamide Applicant name: Conquest Crop Protection Pty Ltd Applicant ACN: 098 814 932 Summary of variation: To extend use to include control of various weeds in canola and grain legumes using

incorporation by sowing Date of variation: 30 June 2017 Product registration no.: 66973 Label approval no.: 66973/107475



Application no.: 107474 Product name: Conquest Dargo 500 WG Selective Herbicide Active constituent/s: 500 g/kg propyzamide Applicant name: Conquest Crop Protection Pty Ltd Applicant ACN: 098 814 932 Summary of variation: To extend use to include control of various weeds in Canola and grain legumes using

incorporation by sowing Date of variation: 3 July 2017 Product registration no.: 69009 Label approval no.: 69009/107474

Application no.: 109233 Product name: Steer 750 Herbicide Active constituent/s: 750 g/kg quinclorac Applicant name: Turf Culture Pty Ltd Applicant ACN: 117 986 615 Summary of variation: To include a statement on transient yellowing Date of variation: 3 July 2017 Product registration no.: 70424 Label approval no.: 70424/109233

Application no.: 107477 Product name: Titan Propyzamide 500SC Herbicide Active constituent/s: 500 g/L propyzamide Applicant name: Titan Ag Pty Ltd Applicant ACN: 122 081 574 Summary of variation: To extend use to include control of various weeds in canola and grain legumes using


Application no.: 107476 Product name: Titan Propyzamide 500 WG Herbicide Active constituent/s: 500 g/kg propyzamide Applicant name: Titan Ag Pty Ltd Applicant ACN: 122 081 574 Summary of variation: To extend use to include control of various weeds in canola and grain legumes using




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.: 104390 Product name: Pharmachem Swat Pour-on Insecticide for Cattle Active constituent/s: 87 g/L permethrin (25:75 cis:trans) Applicant name: Bocko P/L & Flexsky P/L (In Partnership) T/A Pharmachem Applicant ACN: N/A Summary of use: For the control of susceptible buffalo flies (haematobia irritans exigua) and cattle lice

(bovicola bovis, linognathus vituli, haematopinus eurysternus) on beef cattle Date of registration/approval: 20 June 2017 Product registration no.: 81905 Label approval no.: 81905/104390

Application no.: 103401 Product name: Bodyline Pour-On Lousicide For Sheep Active constituent/s: 35 mg/mL imidacloprid Applicant name: Merial Australia Pty Ltd Applicant ACN: 071 187 285 Summary of use: For the control of body lice (bovicola ovis) in sheep Date of registration/approval: 28 June 2017 Product registration no.: 81581 Label approval no.: 81581/103401

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.: 108505 Active constituent/s: Bromacil Applicant name: Jiangsu Flag Chemical Industry Co Ltd Applicant ACN: N/A Summary of use: For use in agricultural chemical products Date of approval: 23 June 2017 Approval no.: 83504/108505

Application no.: 108540 Active constituent/s: Methoxyfenozide Applicant name: Profeng Australia Pty Ltd Applicant ACN: 156 055 533 Summary of use: For use in agricultural chemical products Date of approval: 26 June 2017 Approval no.: 83521/108540

Application no.: 108219 Active constituent/s: Gonadorelin diacetate Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 83412/108219

Approved Active Constituent


Approved Active Constituents—s14

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, s14, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of the approval of the following active constituents, with effect from the dates shown.


N/A

2. VARIATIONS OF ACTIVE CONSTITUENT

Application no.: 109710 Active constituent/s: Thiopentone Sodium Applicant name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 28 April 2017 Approval no.: 56381

Application no.: 106822 Active constituent/s: Detomidine Hydrochloride Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 22 May 2017 Approval no.: 81977

Application no.: 107703 Active constituent/s: Benazepril Hydrochloride Applicant name: Elanco Australasia Pty Ltd Applicant ACN: 076 745 198 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 24 May 2017 Approval no.: 54737

Application no.: 110043 Active constituent/s: Domperidone Applicant name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 30 May 2017 Approval no.: 55480

Application no.: 109856 Active constituent/s: Testosterone Enanthate Applicant name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 31 May 2017 Approval no.: 56358



Approved Active Constituents—s14A

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, s14A, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of the approval of the following active constituents, with effect from the dates shown.


Application no.: 108616 Active constituent/s: Sodium Selenite Applicant name: Merial Australia Pty Ltd Applicant ACN: 071 187 285 Summary of use: For use in veterinary chemical products Date of approval: 31 March 2017 Approval no.: 83558

Application no.: 107527 Active constituent/s: Pyrantel Pamoate Applicant name: Ranvet Pty Limited Applicant ACN: 001 606 033 Summary of use: For use in veterinary chemical products Date of approval: 31 March 2017 Approval no.: 83099

Application no.: 107508 Active constituent/s: Hydroxy Progesterone Caproate Applicant name: Ranvet Pty Limited Applicant ACN: 001 606 033 Summary of use: For use in veterinary chemical products Date of approval: 31 March 2017 Approval no.: 83091

Application no.: 109714 Active constituent/s: Methadone Hydrochloride Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 31 March 2017 Approval no.: 84101

Application no.: 109723 Active constituent/s: Prednisolone Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 31 March 2017 Approval no.: 84109



Application no.: 109721 Active constituent/s: Hydroxocobalamin Acetate Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 3 April 2017 Approval no.: 84107

Application no.: 107518 Active constituent/s: Butaphosphan Applicant name: Ranvet Pty Limited Applicant ACN: 001 606 033 Summary of use: For use in veterinary chemical products Date of approval: 3 April 2017 Approval no.: 83096

Application no.: 107863 Active constituent/s: Dexamethasone Acetate Applicant name: Vetoquinol Australia Pty Ltd Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 3 April 2017 Approval no.: 83263

Application no.: 109724 Active constituent/s: Meloxicam Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 3 April 2017 Approval no.: 84110

Application no.: 108280 Active constituent/s: Alfaxalone Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 3 April 2017 Approval no.: 83437

Application no.: 109726 Active constituent/s: Medetomidine Hydrochloride Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 4 April 2017 Approval no.: 84412



Application no.: 108930 Active constituent/s: Lignocaine Applicant name: Mavlab Pty Ltd Applicant ACN: 009 708 187 Summary of use: For use in veterinary chemical products Date of approval: 4 April 2017 Approval no.: 83754

Application no.: 110086 Active constituent/s: Ketoprofen Applicant name: Modern Veterinary Therapeutics LLC Applicant ACN: N/A Summary of use: For use in veterinary chemical products Date of approval: 5 April 2017 Approval no.: 84311

Application no.: 108935 Active constituent/s: Lignocaine Applicant name: Mavlab Pty Ltd Applicant ACN: 009 708 187 Summary of use: For use in veterinary chemical products Date of approval: 5 April 2017 Approval no.: 83759

Application no.: 109727 Active constituent/s: Febantel Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 5 April 2017 Approval no.: 84413

Application no.: 109732 Active constituent/s: Erythromycin Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use: For use in veterinary chemical products Date of approval: 5 April 2017 Approval no.: 84118

Application no.: 109735 Active constituent/s: Benzylpenicillin Benzathine Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For use in veterinary chemical products Date of approval: 7 April 2017 Approval no.: 84121



Application no.: 110022 Active constituent/s: Levamisole Hydrochloride Applicant name: Vetafarm Pty Ltd Applicant ACN: 059 895 153 Summary of use: For use in veterinary chemical products Date of approval: 11 April 2017 Approval no.: 84265

Application no.: 109831 Active constituent/s: Lincomycin Hydrochloride Applicant name: Dox-Al Australia Pty Ltd Applicant ACN: 079 454 265 Summary of use: For use in veterinary chemical products Date of approval: 19 April 2017 Approval no.: 84165

Application no.: 110298 Active constituent/s: Praziquantel Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd Applicant ACN: 000 233 992 Summary of use: For use in veterinary chemical products Date of approval: 19 April 2017 Approval no.: 84391

Application no.: 110299 Active constituent/s: Lufenuron Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd Applicant ACN: 000 233 992 Summary of use: For use in veterinary chemical products Date of approval: 19 April 2017 Approval no.: 84392

Application no.: 109734 Active constituent/s: Tiamulin Hydrogen Fumarate Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use: For use in veterinary chemical products Date of approval: 27 April 2017 Approval no.: 84120

Application no.: 107599 Active constituent/s: Abamectin Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For use in veterinary chemical products Date of approval: 27 April 2017 Approval no.: 83130



Application no.: 109794 Active constituent/s: Clavulanic Acid (as Potassium Clavulanate) Applicant name: Le Vet Beheer B V Applicant ACN: N/A Summary of use: For use in veterinary chemical products Date of approval: 28 April 2017 Approval no.: 84150

Application no.: 109740 Active constituent/s: Chlortetracycline Hydrochloride Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use: For use in veterinary chemical products Date of approval: 28 April 2017 Approval no.: 84126

Application no.: 108869 Active constituent/s: Oxytetracycline Hydrochloride Applicant name: Mavlab Pty Ltd Applicant ACN: 009 708 187 Summary of use: For use in veterinary chemical products Date of approval: 28 April 2017 Approval no.: 83708

Application no.: 108984 Active constituent/s: Povidone-Iodine Applicant name: Randlab Australia Pty Ltd Applicant ACN: 114 948 837 Summary of use: For use in veterinary chemical products Date of approval: 2 May 2017 Approval no.: 83793

Application no.: 108842 Active constituent/s: Omeprazole 30% Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 2 May 2017 Approval no.: 83684

Application no.: 109668 Active constituent/s: Cyanocobalamin Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of use: For use in veterinary chemical products Date of approval: 3 May 2017 Approval no.: 84086



Application no.: 109731 Active constituent/s: Clorsulon Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of use: For use in veterinary chemical products Date of approval: 19 May 2017 Approval no.: 84117

Application no.: 110553 Active constituent/s: Propylene Glycol Applicant name: Troy Laboratories Pty Ltd Applicant ACN: 000 283 769 Summary of use: For use in veterinary chemical products Date of approval: 19 May 2017 Approval no.: 84514

Application no.: 110554 Active constituent/s: Malic Acid Applicant name: Troy Laboratories Pty Ltd Applicant ACN: 000 283 769 Summary of use: For use in veterinary chemical products Date of approval: 19 May 2017 Approval no.: 84515

Application no.: 110205 Active constituent/s: Propofol Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 23 May 2017 Approval no.: 84364

Application no.: 108662 Active constituent/s: Sulfadiazine Applicant name: Randlab Australia Pty Ltd Applicant ACN: 114 948 837 Summary of use: For use in veterinary chemical products Date of approval: 23 May 2017 Approval no.: 83585

Application no.: 108688 Active constituent/s: Sulfadimidine Applicant name: Randlab Australia Pty Ltd Applicant ACN: 114 948 837 Summary of use: For use in veterinary chemical products Date of approval: 23 May 2017 Approval no.: 83602



Application no.: 108689 Active constituent/s: Phenylbutazone Applicant name: Randlab Australia Pty Ltd Applicant ACN: 114 948 837 Summary of use: For use in veterinary chemical products Date of approval: 24 May 2017 Approval no.: 83603

Application no.: 110208 Active constituent/s: Sodium Salicylate Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 23 May 2017 Approval no.: 84367

Application no.: 109109 Active constituent/s: Shark Cartilage Powder Applicant name: Mavlab Pty Ltd Applicant ACN: 009 708 187 Summary of use: For use in veterinary chemical products Date of approval: 25 May 2017 Approval no.: 83869

Application no.: 109108 Active constituent/s: Abalone Powder Applicant name: Mavlab Pty Ltd Applicant ACN: 009 708 187 Summary of use: For use in veterinary chemical products Date of approval: 25 May 2017 Approval no.: 83868

Application no.: 110038 Active constituent/s: Erythromycin Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 25 May 2017 Approval no.: 84279

Application no.: 109870 Active constituent/s: Cephalonium Dihydrate Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 25 May 2017 Approval no.: 84194



Application no.: 108154 Active constituent/s: Doramectin Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For use in veterinary chemical products Date of approval: 25 May 2017 Approval no.: 83380

Application no.: 110765 Active constituent/s: Moxidectin Applicant name: Polygon (NZ) Limited Applicant ACN: N/A Summary of use: For use in veterinary chemical products Date of approval: 26 May 2017 Approval no.: 84599

Application no.: 109875 Active constituent/s: Prednisolone Acetate Applicant name: Bocko P/L & Flexsky P/L (in partnership) Applicant ACN: 078 722 371 Summary of use: For use in veterinary chemical products Date of approval: 26 May 2017 Approval no.: 84199

Application no.: 109796 Active constituent/s: Buserelin Acetate Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For use in veterinary chemical products Date of approval: 29 May 2017 Approval no.: 84152

Application no.: 109292 Active constituent/s: Clorsulon Applicant name: Norbrook Laboratories Australia Pty Limited Applicant ACN: 080 972 596 Summary of use: For use in veterinary chemical products Date of approval: 31 May 2017 Approval no.: 83939

Application no.: 108847 Active constituent/s: Milbemycin Oxime Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 31 May 2017 Approval no.: 83689



Application no.: 108220 Active constituent/s: Imepitoin Applicant name: Boehringer Ingelheim Pty Limited, Vetmedica Division Applicant ACN: 000 452 308 Summary of use: For use in veterinary chemical products Date of approval: 31 May 2017 Approval no.: 83413

Application no.: 109291 Active constituent/s: Ivermectin Applicant name: Norbrook Laboratories Australia Pty Limited Applicant ACN: 080 972 596 Summary of use: For use in veterinary chemical products Date of approval: 31 May 2017 Approval no.: 83938

Application no.: 109837 Active constituent/s: Chondroitin Sulphate Sodium Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use: For use in veterinary chemical products Date of approval: 31 May 2017 Approval no.: 84170

Application no.: 109842 Active constituent/s: Cephapirin Benzathine Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For use in veterinary chemical products Date of approval: 31 May 2017 Approval no.: 84175

Application no.: 107516 Active constituent/s: Oxantel Embonate Applicant name: Ranvet Pty Limited Applicant ACN: 001 606 033 Summary of use: For use in veterinary chemical products Date of approval: 31 May 2017 Approval no.: 83095

Application no.: 108821 Active constituent/s: Sulfadimidine Sodium Applicant name: CCD Animal Health Pty Ltd Applicant ACN: 151 737 950 Summary of use: For use in veterinary chemical products Date of approval: 1 June 2017 Approval no.: 83667



Application no.: 109733 Active constituent/s: Sodium Hyaluronate Applicant name: Apex Laboratories Pty Ltd Applicant ACN: 614 716 700 Summary of use: For use in veterinary chemical products Date of approval: 1 June 2017 Approval no.: 84119

Application no.: 107138 Active constituent/s: Lignocaine Hydrochloride Applicant name: Kato Laboratories Pty Ltd Applicant ACN: 000 397 240 Summary of use: For use in veterinary chemical products Date of approval: 1 June 2017 Approval no.: 82925

Application no.: 108902 Active constituent/s: Levamisole Hydrochloride Applicant name: CCD Animal Health Pty Ltd Applicant ACN: 151 737 950 Summary of use: For use in veterinary chemical products Date of approval: 1 June 2017 Approval no.: 83736

Application no.: 108836 Active constituent/s: Levamisole Hydrochloride Applicant name: CCD Animal Health Pty Ltd Applicant ACN: 151 737 950 Summary of use: For use in veterinary chemical products Date of approval: 1 June 2017 Approval no.: 83678

Application no.: 110281 Active constituent/s: Sulfadoxine Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 1 June 2017 Approval no.: 84379

Application no.: 109871 Active constituent/s: Butorphanol Tartrate Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For use in veterinary chemical products Date of approval: 1 June 2017 Approval no.: 84195



Application no.: 109866 Active constituent/s: Omeprazole Applicant name: Randlab Australia Pty Ltd Applicant ACN: 114 948 837 Summary of use: For use in veterinary chemical products Date of approval: 1 June 2017 Approval no.: 84191

Application no.: 110126 Active constituent/s: Propylene Glycol Applicant name: Delaval Pty Ltd Applicant ACN: 004 210 459 Summary of use: For use in veterinary chemical products Date of approval: 2 June 2017 Approval no.: 84335

Application no.: 109874 Active constituent/s: Prednisolone Acetate Applicant name: Bocko P/L & Flexsky P/L (in partnership) Applicant ACN: 078 722 371 Summary of use: For use in veterinary chemical products Date of approval: 2 June 2017 Approval no.: 84198

Application no.: 109783 Active constituent/s: Mepivacaine Hydrochloride Applicant name: Troy Laboratories Pty Ltd Applicant ACN: 000 283 769 Summary of use: For use in veterinary chemical products Date of approval: 5 June 2017 Approval no.: 84143

Application no.: 109873 Active constituent/s: Miconazole Nitrate Applicant name: Bocko P/L & Flexsky P/L (in partnership) Applicant ACN: 078 722 371 Summary of use: For use in veterinary chemical products Date of approval: 5 June 2017 Approval no.: 84197

Application no.: 107603 Active constituent/s: Ivermectin Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For use in veterinary chemical products Date of approval: 5 June 2017 Approval no.: 83132



Application no.: 109865 Active constituent/s: Altrenogest Applicant name: Randlab Australia Pty Ltd Applicant ACN: 114 948 837 Summary of use: For use in veterinary chemical products Date of approval: 5 June 2017 Approval no.: 84190

Application no.: 109832 Active constituent/s: Procaine Benzylpenicillin Applicant name: Troy Laboratories Pty Ltd Applicant ACN: 000 283 769 Summary of use: For use in veterinary chemical products Date of approval: 5 June 2017 Approval no.: 84166

Application no.: 109876 Active constituent/s: Isoflurane Applicant name: Bocko P/L & Flexsky P/L (in partnership) Applicant ACN: 078 722 371 Summary of use: For use in veterinary chemical products Date of approval: 5 June 2017 Approval no.: 84200

Application no.: 110030 Active constituent/s: Piperazine Citrate Applicant name: Bocko P/L & Flexsky P/L (in partnership) Applicant ACN: 078 722 371 Summary of use: For use in veterinary chemical products Date of approval: 5 June 2017 Approval no.: 84273

Application no.: 109877 Active constituent/s: Halothane Applicant name: Bocko P/L & Flexsky P/L (in partnership) Applicant ACN: 078 722 371 Summary of use: For use in veterinary chemical products Date of approval: 5 June 2017 Approval no.: 84201

Application no.: 110032 Active constituent/s: Hyoscine Methobromide Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 5 June 2017 Approval no.: 84275



Application no.: 110119 Active constituent/s: Phenylbutazone Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 5 June 2017 Approval no.: 84330

Application no.: 110566 Active constituent/s: Dexpanthenol Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 5 June 2017 Approval no.: 84522

Application no.: 109869 Active constituent/s: Cyromazine Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For use in veterinary chemical products Date of approval: 16 June 2017 Approval no.: 84193

Application no.: 108502 Active constituent/s: Pimobendan Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 21 June 2017 Approval no.: 83503

Application no.: 110045 Active constituent/s: Abamectin Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd Applicant ACN: 000 233 992 Summary of use: For use in veterinary chemical products Date of approval: 26 June 2017 Approval no.: 84285

Application no.: 110151 Active constituent/s: Fenbendazole Applicant name: The Hunter River Company Pty Limited Applicant ACN: 133 798 615 Summary of use: For use in veterinary chemical products Date of approval: 26 June 2017 Approval no.: 84341



Application no.: 108745 Active constituent/s: Phenylbutazone Sodium Applicant name: Randlab Australia Pty Ltd Applicant ACN: 114 948 837 Summary of use: For use in veterinary chemical products Date of approval: 26 June 2017 Approval no.: 83628

Application no.: 110033 Active constituent/s: Cyanocobalamin Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 26 June 2017 Approval no.: 84276

Application no.: 110175 Active constituent/s: Copper Gluconate Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 26 June 2017 Approval no.: 84353

Application no.: 109020 Active constituent/s: Doxycycline Monohydrate Applicant name: Apex Laboratories Pty Ltd Applicant ACN: 614 716 700 Summary of use: For use in veterinary chemical products Date of approval: 27 June 2017 Approval no.: 83816

Application no.: 108798 Active constituent/s: Fipronil Applicant name: Merial Australia Pty Ltd Applicant ACN: 071 187 285 Summary of use: For use in veterinary chemical products Date of approval: 27 June 2017 Approval no.: 83657

Application no.: 108994 Active constituent/s: Carbimazole Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For use in veterinary chemical products Date of approval: 27 June 2017 Approval no.: 83801



Application no.: 110874 Active constituent/s: Oxytetracycline Hydrochloride Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use: For use in veterinary chemical products Date of approval: 27 June 2017 Approval no.: 84589

Application no.: 108775 Active constituent/s: Chlorpheniramine Maleate Applicant name: Mavlab Pty Ltd Applicant ACN: 009 708 187 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 83642

Application no.: 108924 Active constituent/s: Ketamine Hydrochloride Applicant name: Mavlab Pty Ltd Applicant ACN: 009 708 187 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 83748

Application no.: 108786 Active constituent/s: Levamisole Hydrochloride Applicant name: Mavlab Pty Ltd Applicant ACN: 009 708 187 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 83651

Application no.: 108858 Active constituent/s: Praziquantel Applicant name: Mavlab Pty Ltd Applicant ACN: 009 708 187 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 83698

Application no.: 108858 Active constituent/s: Praziquantel Applicant name: Mavlab Pty Ltd Applicant ACN: 009 708 187 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 83698



Application no.: 110296 Active constituent/s: Virginiamycin Applicant name: Phibro Animal Health Pty Limited Applicant ACN: 093 869 991 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 84389

Application no.: 109920 Active constituent/s: Cloxacillin Benzathine Applicant name: Jurox Pty Limited Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 84230

Application no.: 111028 Active constituent/s: Gonadotrohpin Equine Serum Applicant name: Vetoquinol Australia Pty Ltd Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 84644

Application no.: 110976 Active constituent/s: Adrenaline Acid Tartrate Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 84636

Application no.: 110967 Active constituent/s: Thiamine Hydrochloride Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 84629

Application no.: 109872 Active constituent/s: Omeprazole 30% Applicant name: Randlab Australia Pty Ltd Applicant ACN: 114 948 837 Summary of use: For use in veterinary chemical products Date of approval: 28 June 2017 Approval no.: 84196



Application no.: 108375 Active constituent/s: Equine Gamma Globulins Applicant name: Plasvacc Pty Ltd Applicant ACN: 099 547 841 Summary of use: For use in veterinary chemical products Date of approval: 29 June 2017 Approval no.: 83479

Application no.: 108374 Active constituent/s: Canine Gamma Globulins Applicant name: Plasvacc Pty Ltd Applicant ACN: 099 547 841 Summary of use: For use in veterinary chemical products Date of approval: 29 June 2017 Approval no.: 83478

Application no.: 108715 Active constituent/s: Clostridium Septicum AWC471 Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 30 June 2017 Approval no.: 83615

Application no.: 108712 Active constituent/s: Clostridium Novyi Type B AWC469 Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 30 June 2017 Approval no.: 83612



2. VARIATIONS OF ACTIVE CONSTITUENT

Application no.: 109468 Active constituent/s: Bacitracin Zinc Applicant name: Huvepharma Eood Applicant ACN: N/A Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 31 May 2017 Approval no.: 82610

Application no.: 110106 Active constituent/s: Doxapram Hydrochloride Monohydrate Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 26 June 2017 Approval no.: 55077



Amendments to the APVMA MRL Standard

The Australian Pesticides and Veterinary Medicines Authority (APVMA) approves maximum residue limits (MRLs) of agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. The MRLs approved by the APVMA are associated with a regulatory decision to register a product, grant a permit approval, or as an outcome from a review decision and are set out in the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012. The MRL Standard lists MRLs of substances that may arise from the approved use of agricultural and veterinary chemical products containing those substances on commodities used for human consumption as well as livestock feeds. The MRL Standard also provides the relevant residue definitions to which these MRLs apply. There may be situations where the residue definition for monitoring and enforcement is different to the definition used for dietary risk assessment purposes.

MRLs are set at levels which are not likely to be exceeded if the agricultural or veterinary chemicals are used in accordance with approved label instructions. In considering MRLs and variation to MRLs, the APVMA takes into account studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice and dietary exposure. In approving MRLs, the APVMA is satisfied, from dietary exposure assessment, that the levels set are not an undue hazard to human health.

The APVMA has amended the MRL Standard and the changes will have affect the day after the instrument is registered.

Details of the amendment can be found in the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2017 (No. 7).

The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012.

The MRL Standard is accessible via the Federal Register of Legislation website www.legislation.gov.au or the links above.

For further information please contact:

MRL Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4897 Fax: +61 2 6210 4840 Email: [email protected]

Amendments to the APVMA MRL Standard

http://www.comlaw.gov.au/Current/F2012L02501

http://www.comlaw.gov.au/Current/F2012L02501

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



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

In the previous notice on page 30 of APVMA Gazette No. 14, 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 2017 (No. 7)) 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 and 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.

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


PROPOSED VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE (11 July 2017)

Note: Subsection 82(2) of the Food Standards Australia New Zealand Act 1991 provides that variations to standards are legislative instruments, but are not subject to disallowance or sunsetting.

To commence: on gazettal of variation

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

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

Agvet chemical: Abamectin

Permitted residue: Avermectin B1a Custard apple T0.1

Agvet chemical: Cyproconazole

Permitted residue: Cyproconazole, sum of isomers All other foods except animal commodities

0.01

Agvet chemical: Fludioxonil

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

Permitted residue—commodities of plant origin: Fludioxonil

Avocado 2 Agvet chemical: Fluxapyroxad

Permitted residue: Fluxapyroxad

Chick-pea (dry) T*0.01 Lentil (dry) T*0.01

Agvet chemical: Penflufen

Permitted residue: Penflufen


Agvet chemical: Sulfoxaflor

Permitted residue: Sulfoxaflor All other foods except animal food commodities

0.01

Avocado 0.3 Macadamia nuts *0.01



Agvet chemical: Trifloxystrobin

Permitted residue: Sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)-ethylideneaminooxymethyl] phenyl] acetic acid), expressed as trifloxystrobin equivalents


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

Agvet chemical: Azoxystrobin

Permitted residue: Azoxystrobin

Avocado 3 Rape seed (canola) T*0.01

Agvet chemical: Cyproconazole

Permitted residue: Cyproconazole, sum of isomers

Rape seed (canola) T0.02 Agvet chemical: Sulfoxaflor

Permitted residue: Sulfoxaflor

Strawberry 0.5



INVITATION FOR SUBMISSIONS

Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the proposal to vary Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code. Submissions should be strictly confined to relevant matters that the APVMA must consider (such as public health and safety) which are associated with the occurrence of the proposed residues in foods. Comments received outside these grounds will not be considered by the APVMA. Claims made in submissions should be supported wherever possible by referencing or including relevant studies, research findings, trials, surveys etc. Technical information should be in sufficient detail to allow independent scientific assessment.

Please note that FSANZ will make a SPS notification to the WTO and submissions related to impacts on international trade should be made to FSANZ in response to that notification.

Submissions must be made in writing and should be clearly marked as a ‘submission on the proposed amendment to Schedule 20’ and quote the correct amendment number.

DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (AEST) 8 September 2017

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.






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

The Australian Pesticides and Veterinary Medicines Authority (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 in Schedule 20–Maximum Residue Limits of the Australia New Zealand Food Standards Code. This notice pertains to proposals (No. 4) gazetted on 18 April 2017 (No. APVMA 8).

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 14, 2017) accompanies this notice. For a complete and up-to-date version of Schedule 20, including these amendments together with their Explanatory Statement, please refer to the Federal Register of Legislation available on the Legislation website at www.legislation.gov.au

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




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



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

limits Variation Instrument No. APVMA 7, 2017

I, Helen Stokes, Acting Executive Director, Scientific Assessment and Chemical Review and 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.

Helen Stokes Delegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority

Dated this Sixth day of July 2017



Part 1 Preliminary 1 Name of instrument

This instrument is the Australia New Zealand Food Standards Code—Schedule 20−Maximum residue limits Variation Instrument No. APVMA 7, 2017.

2 Commencement

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

Note: A copy of the variations made by the Amendment Instrument was published in the Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette No. APVMA 14 of 11 July 2017.

3 Object

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

4 Interpretation

In this instrument: —

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

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

Part 2 Variations to Schedule 20—Maximum Residue Limits

5 Variations to Schedule 20

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



Schedule Variations to Schedule 20–Maximum residue limits [1] The table to section S20—3 in Schedule 20 is varied by

[1.1] inserting in alphabetical order

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

Agvet chemical: Metalaxyl

Permitted residue: Metalaxyl

Vegetables [except asparagus; beetroot; bulb vegetables [alliums]; fruiting vegetables, cucurbits; leafy vegetables; peppers; podded pea (young pods) (snow and sugar snap peas)]

T0.1

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

Agvet chemical: Iprodione

Permitted residue: Iprodione

Chestnuts T10 Agvet chemical: Metalaxyl


All other foods except animal commodities

0.05

Tomato T0.5 Vegetables [except asparagus; beetroot; bulb vegetables [alliums]; fruiting vegetables, cucurbits; leafy vegetables; peppers; podded pea (young pods) (snow and sugar snap peas); tomatoes]

T0.1

Agvet chemical: Bicyclopyrone

Permitted residue: Bicyclopyrone and its structurally related metabolites determined as the common moieties SYN503780 and CSCD686480 and expressed as bicyclopyrone

Barley 0.02 Edible offal (mammalian) 2 Eggs *0.02 Meat (mammalian) *0.02 Milk *0.02 Poultry, edible offal of *0.02 Poultry meat *0.02 Wheat 0.02 Wheat bran, unprocessed 0.05



Agvet chemical: Propyzamide

Permitted residue: Propyzamide

Pulses *0.01

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

Agvet chemical: Metalaxyl


Cereal grains *0.01



Cancellation of Product Label Approval at the Request of the Holder

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

Product no Product name Registrant/approval holder Cancelled label approval number

Date of effect

68000 LEOPARD 200 EC HERBICIDE

ADAMA AUSTRALIA PTY LIMITED

68000/57249 30 June 2017

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

SUPPLY

A person may supply or cause to be supplied product bearing the cancelled label 68000/57249 manufactured prior to 30 June 2017 at wholesale and retail level, until 30 June 2018.

After 30 June 2018 it will be an offence against the Agvet Codes to have possession or custody of the product bearing label approval 68000/57249 with the intention to supply, or to supply the product.

USE

A person may continue to use the product bearing the cancelled label 68000/57249 according to its label instructions until 30 June 2018.

Any person who possesses, has custody of, uses, or otherwise deals with the product bearing the cancelled label 68000/57249 in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the product bearing the cancelled label until 30 June 2018.

The supply and use of the product bearing the cancelled label approval 68000/57249 must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the product bearing the cancelled label listed in the table in a manner that contravenes the above instructions.

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Chemical Review

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

SYMONSTON ACT 2609

Phone: +61 2 6210 4749

Fax: +61 2 6210 4773

Email: [email protected]

Cancellation of Product Label Approval at the Request of the Holder


Documents

APVMA Gazette No. 14, 11 July 2017...2017/07/11 · No. APVMA 14, Tuesday, 11 July 2017 Published by The Australian Pesticides and Veterinary Medicines Authority AGRICULTURAL AND