apvma gazette no. 1, 10 january 2017 · no. apvma 1, tuesday, 10 january 2017 published by the...

No. APVMA 1, Tuesday, 10 January 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 1, Tuesday, 10 January 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.

DISTRIBUTION AND SUBSCRIPTION

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www.apvma.gov.au/news-and-publications/publications/gazette

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

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http://www.apvma.gov.au/news-and-publications/publications/gazette


CONTENTS

Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and Approved Labels .................................................................................................... 12 Approved Active Constituents ....................................................................................................................................... 14 Approved Active Constituents—Veterinary ................................................................................................................... 16 Approved Active Constituents—Veterinary ................................................................................................................... 18 Amendments to the APVMA MRL Standard .................................................................................................................. 31 Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code ................................................. 32 Variations to Schedule 20 of the Australia New Zealand Food Standards Code ........................................................... 36 Revocation of Suspension of a Product Containing Dimethoate to Allow Approval of New Label ................................. 42


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.: 107283 Product name: Agsure Oxyfluorfen 240 Herbicide Active constituent/s: 240 g/L oxyfluorfen Applicant name: Elders Rural Services Australia Limited Applicant ACN: 004 045 121 Summary of use For selective weed control of broadleaf weeds and some grasses Date of registration: 10 August 2016 Product registration no.: 82998 Label approval no.: 82998/107283

Application no.: 106864

Product name: Relyon Futura 500SC Fungicide

Active constituent/s: 500 g/L flutriafol

Applicant name: Ruralco Holdings Limited

Applicant ACN: 009 660 879

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

Date of registration: 22 November 2016

Product registration no.: 82826

Label approval no.: 82826/106864

Application no.: 107561 Product name: Relyon Lawthal 750WG Herbicide Active constituent/s: 750 g/kg chlorthal-dimethyl Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For pre-emergence weed control in certain vegetable crops including onions, beans,

cabbages, potatoes, carrots and for weed control in strawberries, cotton, lucerne, perennial grass crops, lawns and ornamentals

Date of registration: 22 November 2016 Product registration no.: 83116 Label approval no.: 83116/107561


Product name: Apparent Ant-Assassin Granular Ant Killer

Active constituent/s: 2 g/kg bifenthrin

Applicant name: Apparent Pty. Ltd. Applicant ACN: 143 724 136 Summary of use For the control of ants in the home garden





http://portal/ApplicationArea/Applications/NavigateToEntity/82826



Product name: Macro Protect Flutriafol 500 SC Fungicide


Applicant name: Macrofertil Australia Pty Ltd


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





Product name: Brandt Indicate 5 Adjuvant

Active constituent/s: 266.2 g/L nonoxynol-9, 375.1 g/L phosphoric acid derivatives

Applicant name: Brandt Consolidated Inc

Applicant ACN: N/A

Summary of use For use as a wetter-spreader containing a pH indicator, for use as a penetration, buffering and compatibility aid with alkaline sensitive pesticides, herbicides and foliar fertilisers


Product registration no.: 83121 Label approval no.: 83121/107578


Product name: Relyon Tuxedo 224 Herbicide

Active constituent/s: 224 g/L acifluorfen (present as the sodium salt)



Summary of use For the selective control of certain broadleaf weeds and grasses in mung beans, peanuts, soybeans, green beans and seed crops of siratro and stylo

Date of registration: 29 November 2016 Product registration no.: 83182


Application no.: 105293 Product name: Genfarm Triclopyr 755EC Herbicide Active constituent/s: 755 g/L triclopyr present as the butoxyethyl ester Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use For control of a range of woody weeds and melons in various situations Date of registration: 29 November 2016 Product registration no.: 82254 Label approval no.: 82254/105293


Product name: Eureka! Atrazine 900 WG Herbicide

Active constituent/s: 900 g/kg atrazine

Applicant name: Eureka! Agresearch Pty Ltd


Summary of use For the control of weeds and grasses in sorghum, maize, sugarcane, TT-canola, lucerne and for fallow area maintenance and other situations

Date of registration: 1 December 2016






Product name: Total Health Care Insecticide Miticide

Active constituent/s: 40 g/L permethrin (40:60, cis:trans), 56 g/L benzalkonium chloride

Applicant name: Zuccon Pty Ltd Applicant ACN: 005 875 767

Summary of use For use in industrial situations associated with the manufacture of polyurethane foam, fibre, textile and carpet products for the purpose of controlling bed-bugs and dust mites on the treated articles




Product name: Maradona 750 Herbicide

Active constituent/s: 750 g/L MCPA present as the dimethylamine salt

Applicant name: Crop Culture Pty Ltd

Applicant ACN: 142 860 473 Summary of use For the selective control of broadleaf weeds in cereals, linseed, pastures, rice, sugarcane

and turf Date of registration: 5 December 2016



Application no.: 107701 Product name: Relyon Descend TDZ Cotton Defoliant Active constituent/s: 500 g/L thidiazuron Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For the defoliation of cotton prior to harvest. Date of registration: 05 December 2016 Product registration no.: 83190 Label approval no.: 83190/107701


Product name: Titan Duelling SA Spray Adjuvant

Active constituent/s: 704g/L methyl and ethyl esters of free fatty acids derived from refined canola oil

Applicant name: Titan Ag Pty Ltd


Summary of use For use to enhance the effectiveness of certain herbicides, pyrethroid insecticides, defoliants and desiccants

Date of registration: 6 December 2016 Product registration no.: 83320


Application no.: 107108 Product name: Agsure 2,4-D Amine 625 Herbicide Active constituent/s: 625 g/L 2,4-D present as the dimethylamine and diethanolamine salts Applicant name: Elders Rural Services Australia Limited Applicant ACN: 004 045 121 Summary of use For the control of broadleaf weeds in fallow before direct drilling or sowing of cereals and

pastures; and in cereal crops, pastures, sugar cane, peanuts and non-agricultural areas Date of registration: 6 December 2016 Product registration no.: Label approval no.:

82915 82915/107108




Product name: Eureka! Flutriafol 600 SC Fungicide


Applicant name: Eureka! Agresearch (Vic) Pty Ltd


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




Application no.: 107083 Product name: Genfarm 2,4-D Amine 625 Selective Herbicide Active constituent/s: 625 g/L 2, 4-D present as the dimethylamine and diethanolamine saltsApplicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use For the control of broadleaf weeds in fallow Date of registration: 8 December 2016 Product registration no.: 82899 Label approval no.: 82899/107083

Application no.: 107627 Product name: Relyon Perturb MA Herbicide Active constituent/s: 275 g/L terbutryn, 160 g/L MCPA present as the potassium salt Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For the control of seedling broadleaf weeds in wheat, barley, some varieties of oats,

pasture and sugarcane

Date of registration: 8 December 2016 Product registration no.: 83143 Label approval no.: 83143/107627


Product name: Farmalinx Sputnik Herbicide

Active constituent/s: 875 g/kg terbuthylazine

Applicant name: Farmalinx Pty Ltd


Summary of use For the control of weeds in chickpeas, faba beans, field peas and lupins

Date of registration/approval: 9 December 2016



Application no.: 107969 Product name: Dairy Power Aquasan Concentrate Low Foam Acid Detergent Sanitiser Active constituent/s: 425 g/L phosphoric acid, 453 g/L sulfuric acid Applicant name: Ecolab Pty Limited Applicant ACN: 000 449 990 Summary of use For the cleaning of high velocity dairy milking plants Date of registration: 12 December 2016 Product registration no.: 83318 Label approval no.: 83318/107969



Application no.: 106389 Product name: Titan Aluminium Phosphide Blanket Active constituent/s: 330 g/kg phosphine (PH3) present as aluminium phosphide Applicant name: Titan Ag Pty Ltd Applicant ACN: 122 081 574 Summary of use For control of insect pests of stored products in certain situations Date of registration: 12 December 2016 Product registration no.: 82665 Label approval no.: 82665/106389

Application no.: 107562 Product name: Relyon Lymo 225 Insecticide Active constituent/s: 225 g/L methomyl (an anti-cholinesterase compound) Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For the control of insect pests in various crops Date of registration: 12 December 2016 Product registration no.: 83117 Label approval no.: 83117/107562


Product name: Relyon Galoxy 250SC Fungicide

Active constituent/s: 250 g/L azoxystrobin



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




Product name: Kenso Agcare Fumiken Fumigation Bag Chains

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

Applicant name: Kenso Corporation (M) SDN. BHD

Applicant ACN: NA Summary of use For control of insect pests of stored products in certain situations




Application no.: 107392 Product name: Sledge Herbicide Active constituent/s: 25 g/L pyraflufen-ethyl Applicant name: Sipcam Pacific Australia Pty Ltd Applicant ACN: 073 176 888 Summary of use For improvement in the brownout of a range of broadleaf and grass weeds Date of registration: 16 December 2016 Product registration no.: 83053 Label approval no.: 83053/107392



Application no.: 104019 Product name: Selontra Soft Bait Rodenticide Active constituent/s: 0.75 g/kg colecalcifrol Applicant name: BASF Australia Ltd Applicant ACN: 008 437 867 Summary of use For control of rats and mice in and around industrial, commercial, agricultural and domestic

buildings Date of registration: 16 December 2016 Product registration no.: 81767 Label approval no.: 81767/104019

Application no.: 107848 Product name: Spalding Caperjet Selective Herbicide Active constituent/s: 340 g/L MCPA (present as the dimethylamine salt),80g/L dicamba (present as the

dimethylamine salt) Applicant name: Spalding Holdings Pty. Ltd Applicant ACN: 010 155 852 Summary of use For the control of certain broadleaf weeds in winter cereals, pastures, turf and non-crop

areas Date of registration: 16 December 2016 Product registration no.: 83255 Label approval no.: 83255/107848


Product name: Tollman 2,4-D LV Ester 680 Herbicide

Active constituent/s: 680 g/L 2,4-D present as the ethylhexyl ester Applicant name: Tollman Pty Ltd


Summary of use For the selective control of weeds in crops and pastures




Application no.: 107382 Product name: Relyon Disrobe 720 Plant Growth Regulator Active constituent/s: 720 g/L ethephon (an anti-cholinesterase compound) Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For crop thinning, loosening or ripening in various crops and for accelerating boll opening,

defoliation and pre-conditioning before defoliation of cotton. Date of registration: 19 December 2016 Product registration no.: 83047 Label approval no.: 83047/107382

Application no.: 107548 Product name: Brandt Tarp Extender Sticker Spreader Active constituent/s: 904 g/L di-1-p-menthene Applicant name: Brandt Consolidated Inc Applicant ACN: N/A Summary of use Non-aqueous concentrate of sticker-spreader agent for the control of the life of pesticides Date of registration: 19 December 2016 Product registration no.: 83108 Label approval no.: 83108/107548



Application no.: 107406 Product name: Relyon Glyphix 360 Herbicide Active constituent/s: 360 g/L glyphosate present as the isopropylamine salt Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For the control of a broad range of annual perennial and aquatic weeds Date of registration/approval: 20 December 2016 Product registration no.: 83062 Label approval no.: 83062/107406

Application no.: 105244 Product name: Qualipro Evolution Fungicide Active constituent/s: 200 g/L tebuconazole,120g/L azoxystrobin Applicant name: Adama Australia Pty Limited Applicant ACN: 050 328 973 Summary of use For use in turf for the control of various diseases Date of registration: 21 December 2016 Product registration no.: 82231 Label approval no.: 82231/105244

2. VARIATIONS OF REGISTRATION

Application no: 108169 Product name: Apparent Lawn Buff Weeder Active constituent/s: 200 g/L bromoxynil present as the octanoic acid ester, 200 g/L MCPA present as the

butoxyethanol ester Applicant name: Apparent Pty. Ltd Applicant ACN: 143 724 136 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘APPARENT BUFFALO LAWN WEEDER’ to ‘APPARENT LAWN BUFF WEEDER’ Date of variation: 10 October 2016 Product registration no.: 82872 Label approval no.: 82872/108169

Application no: 106828 Product name: IXOM Liquid Pool Chlorine for Swimming Pools Hypochlorite Solution Active constituent/s: 125 g/L available chlorine present as sodium hypochlorite Applicant name: IXOM Operations Pty Ltd Applicant ACN: 600 546 512 Summary of variation: To change the product name from 'ORICA LIQUID POOL CHLORINE FOR SWIMMING

POOLS HYPOCHLORITE SOLUTION' to 'IXOM LIQUID POOL CHLORINE FOR SWIMMING POOLS HYPOCHLORITE SOLUTION'

Date of variation: 5 December 2016 Product registration no.: 51122 Label approval no.: 51122/106828



Application no: 103989 Product name: Des-O-Germ SP Agricultural Disinfectant Active constituent/s: 96 g/L didecyl dimethyl ammonium chloride Applicant name: Des-O-Germ (Pty) Ltd Applicant ACN: N/A Summary of variation: To extend the use to control trichoderma atroviridae on hard surfaces in mushroom sheds Date of variation: 20 December 2016 Product registration no.: 62317 Label approval no.: 62317/103989

3. LABEL APPROVAL

Application no.: 107742 Product name: Hy-Clor High Performance Pool Tablets Active constituent/s: 610 g/kg chlorine present as trichloroisocyanuric acid, 320 g/kg sodium tetraborate

pentahydrate Applicant name: Hy-Clor (Australia) Pty Ltd Applicant ACN: 000 655 381 Summary of use: To approve a new label name for the product with the label name ‘SWIMFREE HIGH

PERFORMANCE TABLETS’ Date of approval: 5 December 2016 Label approval no.: 80624/107742

Application no.: 107914 Product name: Yates Mavrik Gun Chewing & Sucking Insect Pest Killer Active constituent/s: 0.1 g/L tau-fluvalinate Applicant name: Duluxgroup (Australia) Pty Ltd Applicant ACN: 000 049 427 Summary of use: To approve a new label for the product with the label name ‘YATES CATERPILLAR AND

INSECT SPRAY’ Date of approval: 7 December 2016 Label approval no.: 60182/107914

Application no.: 107927 Product name: Low Toxic For You And Your Garden Yates Nature’s Way Vegetable Dust Derris Active constituent/s: 7.5 g/kg rotenone Applicant name: Duluxgroup (Australia) Pty Ltd Applicant ACN: 000 049 427 Summary of use: To approve a new label for the product with the label name ‘YATES VEGETABLE DUST

DERRIS’ Date of approval: 7 December 2016 Label approval no.: 33216/107927

4. VARIATION OF LABEL APPROVAL

Application no.: 107723 Product name: Country Imidacloprid 200 SC Termiticide Active constituent/s: 200 g/L imidacloprid Applicant name: Garrards Pty Ltd Applicant ACN: 010 648 325 Summary of variation: To amend the service period details on the label Date of variation: 5 December 2016 Label approval no.: 60576/107723



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 NEW ACTIVE CONSTITUENTS

Application no.: 61832 Product name: Osphos 51 mg/mL Solution For Injection For Horses Active constituent/s: 51 mg/mL clodronic acid (as clodronate disodium tetrahydrate 75 mg/mL) Applicant name: Dechra Ltd Applicant ACN: N/A Summary of use For the improvement of lameness associated with navicular syndrome in horses

Date of registration/approval: 8 December 2016 Product registration no.: 69825 Label approval no.: 69825/61832

2. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Application no.: 107935 Product name: Frontline Pet Care Medicated Shampoo Active constituent/s: 20 g/L chlorhexidine gluconate, 20 g/L miconazole nitrate Applicant name: Merial Australia Pty Ltd Applicant ACN: 071 187 285 Summary of use For the topical treatment of non-specific dermatological conditions in dogs and cats Date of registration: 7 December 2016 Product registration no.: 83306 Label approval no.: 83306/107935

Application no.: 108222 Product name: Inflacam Injection Active constituent/s: 20 mg/mL meloxicam Applicant name: Bimeda (Australia) Pty Limited Applicant ACN: 058 196 508 Summary of use For use as a non-steroidal anti-inflammatory, analgesic and antipyretic in cattle, pigs and

horses Date of registration: 16 December 2016 Product registration no.: 83415 Label approval no.: 83415/108222



Application no.: 107870 Product name: Exelpet Ezy-Dose Intestinal All-Wormer Chews For Small Dogs & Puppies Active constituent/s: Each chew contains 543 mg oxantel embonate, 143 mg pyrantel embonate and 50 mg

praziquantel Applicant name: Exelpet Products A Div Of Mars Australia Pty Ltd Applicant ACN: 008 454 313 Summary of use For the control of roundworm, hookworm, whipworm and tapeworm including hydatid

tapeworm in small dogs and puppies Date of registration: 21 December 2016 Product registration no.: 83271 Label approval no.: 83271/107870

3. VARIATIONS OF REGISTRATION

Application no: 108397 Product name: CCD OTC 200 Active constituent/s: 200 g/kg oxytetracycline hydrochloride Applicant name: CCD Animal Health Pty Ltd Applicant ACN: 151 737 950 Summary of variation: To change the distinguishing product name and the name that appears on

the label from ‘TETRACIN 200’ to ‘CCD OTC 200’ Date of variation: 28 October 2016 Product registration no.: 42338 Label approval no.: 42338/108397

Application no: 106736 Product name: Tri-Solfen Topical Anaesthetic & Antiseptic Solution For Pain Relief In Lambs and

Calves Active constituent/s: 40.6 g/L lignocaine (as hydrochloride), 4.2 g/L bupivacaine (as hydrochloride),

24.8 mg/L adrenaline (as acid tartrate), 5.0 g/L cetrimide Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: To extend use for pain relief during and following castration in calves Date of variation: 13 December 2016 Product registration no.: 60099 Label approval no.: 60099/106736



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 CONSITUTENT

Application no.: 106124 Active constituent/s: Clodronate disodium tetrahydrate Applicant name: Dechra Ltd Applicant ACN: n/a Summary of use: For use in veterinary chemical products Date of approval: 7 December 2016 Approval no.: 82580

Application no.: 106251 Active constituent/s: Florasulam Applicant name: FMC Australasia Pty Ltd Applicant ACN: 095 326 891 Summary of use: For use in agricultural chemical products Date of approval: 9 December 2016 Approval no.: 82595

Application no.: 101982 Active constituent/s: Sarolaner Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use: For use in veterinary chemical products Date of approval: 13 December 2016 Approval no.: 80944

Application no.: 105450 Active constituent/s: Indoxacarb Applicant name: Adama Australia Pty Limited Applicant ACN: 050 328 973 Summary of use: For use in agricultural chemical products Date of approval: 15 December 2016 Approval no.: 82333

Application no.: 106404 Active constituent/s: Atrazine Applicant name: Syngenta Australia Pty Ltd Applicant ACN: 002 933 717 Summary of use: For use in agricultural chemical products Date of approval: 16 December 2016 Approval no.: 82669



Application no.: 104805 Active constituent/s: Buprenorphine Hydrochloride Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 16 December 2016 Approval no.: 82019

Application no.: 106264 Active constituent/s: Prothioconazole Applicant name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of use: For use in agricultural chemical products Date of approval: 19 December 2016 Approval no.: 82619

Application no.: 104820 Active constituent/s: Oestradiol benzoate 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: 20 December 2016 Approval no.: 82027



Approved Active Constituents—Veterinary

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.


Application no.: 107664 Active constituent/s: Mycoplasma Hyopneumoniae Inactivated Strain J Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use: For use in veterinary chemical products Date of approval: 23 December 2016 Approval no.: 83162

2. VARIATIONS OF ACTIVE CONSTITUENT

Application no.: 107510 Active constituent/s: Oestradiol Dipropionate Applicant name: RWR Veterinary Products Pty Ltd Applicant ACN: 088 423 018 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 13 December 2016 Approval no.: 55899

Application no.: 107506 Active constituent/s: Praziquantel Applicant name: RWR Veterinary Products Pty Ltd Applicant ACN: 088 423 018 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 13 December 2016 Approval no.: 82362

Application no.: 107502 Active constituent/s: Ivermectin Applicant name: RWR Veterinary Products Pty Ltd Applicant ACN: 088 423 018 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 13 December 2016 Approval no.: 82361

Application no.: 107492 Active constituent/s: Glucosamine Hydrochloride Applicant name: RWR Veterinary Products Pty Ltd Applicant ACN: 088 423 018 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 15 December 2016 Approval no.: 82107



Application no.: 107495 Active constituent/s: Econazole Nitrate Applicant name: Ranvet Pty. Limited Applicant ACN: 001 606 033 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 15 December 2016 Approval no.: 55101

Application no.: 107501 Active constituent/s: Nandrolone Decanoate Applicant name: Ranvet Pty. Limited Applicant ACN: 001 606 033 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 15 December 2016 Approval no.: 55845

Application no.: 107014 Active constituent/s: Frusemide Applicant name: Apex Laboratories Pty Ltd Applicant ACN: 000 397 240 Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 23 December 2016 Approval no.: 82061




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.: 105351 Active constituent/s: Ferric Pyrophosphate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 24 November 2016 Approval no.: 82279

Application no.: 107267 Active constituent/s: Fenbendazole Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 1 December 2016 Approval no.: 82989

Application no.: 106336 Active constituent/s: Retinyl Acetate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 1 December 2016 Approval no.: 82641

Application no.: 106567 Active constituent/s: Fluazuron 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: 7 December 2016 Approval no.: 82732

Application no.: 106858 Active constituent/s: Magnesium Chloride Hexahydrate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 82821



Application no.: 107211 Active constituent/s: Ceftiofur as Ceftiofur Sodium Applicant name: Zamira Life Sciences Pty Ltd Applicant ACN: 130 641 502 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 82958

Application no.: 107213 Active constituent/s: Ivermectin Applicant name: Chemvet Australia Pty Ltd Applicant ACN: 138 711 289 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 82959

Application no.: 107270 Active constituent/s: Clorsulon Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 82991

Application no.: 107282 Active constituent/s: Acepromazine Maleate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 82997

Application no.: 107284 Active constituent/s: Moxidectin Technical Concentrate (MTC) Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 82999

Application no.: 107285 Active constituent/s: Moxidectin Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 83000



Application no.: 107296 Active constituent/s: Levamisole Hydrochloride Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 83005

Application no.: 107298 Active constituent/s: Potassium Chloride Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 83007

Application no.: 107325 Active constituent/s: Imidacloprid Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 83018

Application no.: 107202 Active constituent/s: Ractopamine Hydrochloride Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 82952

Application no.: 107297 Active constituent/s: Levamisole Hydrochloride Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 8 December 2016 Approval no.: 83006

Application no.: 107240 Active constituent/s: Prednisolone Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 9 December 2016 Approval no.: 82971



Application no.: 107246 Active constituent/s: Closantel Sodium Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 9 December 2016 Approval no.: 82975

Application no.: 106492 Active constituent/s: Probiotic Concentrate Applicant name: International Animal Health Products Pty Ltd Applicant ACN: 003 185 699 Summary of use: For use in veterinary chemical products Date of approval: 9 December 2016 Approval no.: 82689

Application no.: 106505 Active constituent/s: Monensin 400 Applicant name: International Animal Health Products Pty Ltd Applicant ACN: 003 185 699 Summary of use: For use in veterinary chemical products Date of approval: 9 December 2016 Approval no.: 82702

Application no.: 108202 Active constituent/s: Sodium Ascorbate Applicant name: Ceva Animal Health Pty Ltd Applicant ACN: 002 692 426 Summary of use: For use in veterinary chemical products Date of approval: 9 December 2016 Approval no.: 83407

Application no.: 108098 Active constituent/s: Dembrexine Hydrochloride 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: 9 December 2016 Approval no.: 83346

Application no.: 107950 Active constituent/s: Praziquantel Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products Date of approval: 9 December 2016 Approval no.: 83309



Application no.: 108068 Active constituent/s: Eprinomectin Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use: For use in veterinary chemical products Date of approval: 9 December 2016 Approval no.: 83333

Application no.: 106420 Active constituent/s: Calcium Iodate Applicant name: Agrimin Ltd Applicant ACN: N/A Summary of use: For use in veterinary chemical products Date of approval: 9 December 2016 Approval no.: 82678

Application no.: 107706 Active constituent/s: Detomidine Hydrochloride Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 12 December 2016 Approval no.: 83194

Application no.: 107368 Active constituent/s: N-Octyl Bicycloheptene Dicarboximide (MGK 264)Applicant name: Virbac (Australia) Pty LtdApplicant ACN: 003 268 871Summary of use: For use in veterinary chemical productsDate of approval: 12 December 2016Approval no.: 83040

Application no.: 107370 Active constituent/s: Diethyltoluamide Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 12 December 2016 Approval no.: 83042

Application no.: 107338 Active constituent/s: Oxfendazole Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 12 December 2016 Approval no.: 83024



Application no.: 107367 Active constituent/s: Nitroxynil Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 12 December 2016 Approval no.: 83039

Application no.: 107371 Active constituent/s: Morantel Citrate Monohydrate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 12 December 2016 Approval no.: 83043

Application no.: 107398 Active constituent/s: Phenylbutazone Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 12 December 2016 Approval no.: 83057

Application no.: 107378 Active constituent/s: Menthol (Crystals) Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 12 December 2016 Approval no.: 83045

Application no.: 107379 Active constituent/s: L- Lysine HydrochlorideApplicant name: Virbac (Australia) Pty LtdApplicant ACN: 003 268 871Summary of use: For use in veterinary chemical productsDate of approval: 12 December 2016Approval no.: 83046

Application no.: 107412 Active constituent/s: Permethrin Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 12 December 2016 Approval no.: 83063



Application no.: 107191 Active constituent/s: Tylosin Tartrate Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use: For use in veterinary chemical products Date of approval: 12 December 2016 Approval no.: 82948

Application no.: 107139 Active constituent/s: Amoxycillin Trihydrate Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use: For use in veterinary chemical products Date of approval: 12 December 2016 Approval no.: 82926

Application no.: 107491 Active constituent/s: Hydroxy Progesterone Hexanoate Applicant name: RWR Veterinary Products Pty Ltd Applicant ACN: 088 423 018 Summary of use: For use in veterinary chemical products Date of approval: 13 December 2016 Approval no.: 83088

Application no.: 106836 Active constituent/s: Calcium D-Pantothenate BP Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 15 December 2016 Approval no.: 82813

Application no.: 107636 Active constituent/s: Gentamicin Sulfate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 15 December 2016 Approval no.: 83147

Application no.: 107640 Active constituent/s: Cefalexin Monohydrate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 15 December 2016 Approval no.: 83151



Application no.: 107493 Active constituent/s: Morantel Tartrate Applicant name: RWR Veterinary Products Pty Ltd Applicant ACN: 088 423 018 Summary of use: For use in veterinary chemical products Date of approval: 15 December 2016 Approval no.: 83089

Application no.: 107552 Active constituent/s: Oestradiol Benzoate 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: 15 December 2016 Approval no.: 83110

Application no.: 107489 Active constituent/s: Abamectin Applicant name: RWR Veterinary Products Pty Ltd Applicant ACN: 088 423 018 Summary of use: For use in veterinary chemical products Date of approval: 15 December 2016 Approval no.: 83087

Application no.: 107607 Active constituent/s: Moxidectin Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For use in veterinary chemical products Date of approval: 15 December 2016 Approval no.: 83135

Application no.: 107661 Active constituent/s: Nitroxynil Applicant name: Merial Australia Pty Ltd Applicant ACN: 071 187 285 Summary of use: For use in veterinary chemical products Date of approval: 15 December 2016 Approval no.: 83160

Application no.: 106826 Active constituent/s: Moxidectin Applicant name: Norbrook Laboratories Australia Pty Limited Applicant ACN: 080 972 596 Summary of use: For use in veterinary chemical products Date of approval: 20 December 2016 Approval no.: 82808



Application no.: 106885 Active constituent/s: Deltamethrin 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: 21 December 2016 Approval no.: 82838

Application no.: 104807 Active constituent/s: Fipronil Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 21 December 2016 Approval no.: 82020

Application no.: 106876 Active constituent/s: Calcium Gluconate 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: 21 December 2016 Approval no.: 82833

Application no.: 106419 Active constituent/s: Cobalt Carbonate Applicant name: Agrimin Ltd Applicant ACN: N/A Summary of use: For use in veterinary chemical products Date of approval: 22 December 2016 Approval no.: 82677

Application no.: 107883 Active constituent/s: Follicle Stimulating Hormone Applicant name: Vetoquinol Australia Pty Ltd Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 22 December 2016 Approval no.: 83280

Application no.: 107975 Active constituent/s: Prednisolone Acetate 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: 22 December 2016 Approval no.: 83321



Application no.: 107861 Active constituent/s: Praziquantel Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 22 December 2016 Approval no.: 83261

Application no.: 107705 Active constituent/s: Hydroxocobalamin Acetate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 22 December 2016 Approval no.: 83193

Application no.: 107744 Active constituent/s: Riboflavin Sodium Phosphate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 22 December 2016 Approval no.: 83218

Application no.: 108127 Active constituent/s: Deslorelin Acetate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 22 December 2016 Approval no.: 83365

Application no.: 107399 Active constituent/s: Colloidal Oat Flour Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 22 December 2016 Approval no.: 83058

Application no.: 107400 Active constituent/s: Pyriproxyfen Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 23 December 2016 Approval no.: 83059



Application no.: 108157 Active constituent/s: Imidacloprid Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For use in veterinary chemical products Date of approval: 23 December 2016 Approval no.: 83383

Application no.: 108198 Active constituent/s: Niclosamide Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products Date of approval: 23 December 2016 Approval no.: 83405

Application no.: 108214 Active constituent/s: Xylazine Hydrochloride 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 December 2016 Approval no.: 83408

Application no.: 108215 Active constituent/s: Hydrocortisone Acetate 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 December 2016 Approval no.: 83409

Application no.: 108141 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: 23 December 2016 Approval no.: 83372

Application no.: 108171 Active constituent/s: Deslorelin Acetate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 23 December 2016 Approval no.: 83391



Application no.: 108216 Active constituent/s: Amoxycillin Trihydrate Applicant name: CCD Animal Health Pty Ltd Applicant ACN: 151 737 950 Summary of use: For use in veterinary chemical products Date of approval: 23 December 2016 Approval no.: 83410

Application no.: 108286 Active constituent/s: Clenbuterol Hydrochloride 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: 23 December 2016 Approval no.: 83441

Application no.: 108287 Active constituent/s: Oxytetracycline Dihydrate 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: 23 December 2016 Approval no.: 83442

Application no.: 108176 Active constituent/s: Trenbolone Acetate Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use: For use in veterinary chemical products Date of approval: 9 December 2016 Approval no.: 83394

Application no.: 108153 Active constituent/s: Levamisole Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For use in veterinary chemical products Date of approval: 23 December 2016 Approval no.: 83379

Application no.: 108155 Active constituent/s: Fenbendazole Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For use in veterinary chemical products Date of approval: 23 December 2016 Approval no.: 83381



Application no.: 108156 Active constituent/s: Albendazole Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use: For use in veterinary chemical products Date of approval: 23 December 2016 Approval no.: 83382

Application no.: 107886 Active constituent/s: Marbofloxacin Applicant name: Vetoquinol Australia Pty Ltd Applicant ACN: 006 949 480 Summary of use: For use in veterinary chemical products Date of approval: 23 December 2016 Approval no.: 83282

Application no.: 107641 Active constituent/s: Miconazole Nitrate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of use: For use in veterinary chemical products Date of approval: 4 January 2017 Approval no.: 83152

Application no.: 107782 Active constituent/s: Pimobendan Applicant name: Kato Laboratories Pty Ltd Applicant ACN: 000 397 240 Summary of use: For use in veterinary chemical products Date of approval: 6 January 2017 Approval no.: 83228

Application no.: 108788 Active constituent/s: Miconazole Nitrate Applicant name: Mavlab Pty. Ltd Applicant ACN: 009 708 187 Summary of use: For use in veterinary chemical products Date of approval: 6 January 2017 Approval no.: 83653



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. 1).

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 ComLaw website www.comlaw.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 4840Email: [email protected]

Amendments to the APVMA MRL Standard

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

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



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

In the previous notice, the APVMA gazetted amendments which it has approved varying maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in the APVMA’s MRL Standard, have been made.

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. 1)) 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 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 Government of Australia and the Government of New Zealand concerning a Joint Food Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.

Food Standards Australia New Zealand (FSANZ) 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.



PROPOSED VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE (10 January 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 in alphabetical order

Agvet chemical: Metazachlor

Commodities of plant origin: Sum of metabolites 479M04 (N-(2,6-dimethylphenyl)-N-(1H-pyrazol-1-ylmethyl)oxalamide), 479M08 (N-(2,6-dimethylphenyl)-N-(1H-pyrazol-1-ylmethyl)aminocarbonylmethylsulfonic acid) and 479M16 (3-[N-(2,6-dimethylphenyl)-N-(1H-pyrazol-1-ylmethyl)aminocarbonylmethylsulfinyl]-2-hydroxypropanoic acid), expressed as metazachlor Commodities of animal origin: Sum of metazachlor and its metabolites containing the 2,6-dimethylaniline moiety, expressed as metazachlor

All other foods 1 Cereal grains *0.03Eggs *0.05Edible offal (mammalian) *0.05Meat (mammalian) *0.05Milks *0.01Oilseeds *0.03Poultry, edible offal *0.05Poultry meat *0.05Pulses *0.03

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

Agvet chemical: Flonicamid

Permitted residue: Flonicamid [N -(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide] and its metabolites TFNA [4-trifluoromethylnicotinic acid], TFNA-AM [4-trifluoromethylnicotinamide] TFNG [N -(4-trifluoromethylnicotinoyl)glycine] Apple 0.7



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

Agvet chemical: Boscalid

Permitted residue—commodities of plant origin: Boscalid

Permitted residue—commodities of animal origin: Sum of boscalid, 2-chloro-N-(4′-chloro-5-hydroxybiphenyl-2-yl) nicotinamide and the glucuronide conjugate of 2-chloro-N-(4′-chloro-5-hydroxybiphenyl-2-yl) nicotinamide, expressed as boscalid equivalents

Peanut T0.1 Peanut oil, edible T0.7

Agvet chemical: Flonicamid

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

Strawberry T2 Pome fruits 0.7

Agvet chemical: Fluopyram

Permitted residue—commodities of plant origin: Fluopyram

Permitted residue—commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyram

Rape seed (canola) T*0.01

Agvet chemical: Imazamox

Permitted residue: Imazamox Mung bean (dry) T*0.05

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

Agvet chemical: Propiconazole

Permitted residue: Propiconazole Sunflower seed T0.5

Agvet chemical: Pyrimethanil

Permitted residue: Pyrimethanil Pome fruits T15



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 (ADST) 7 February 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.


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




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. 12) gazetted on 6 September 2016 (No. APVMA 18) and (No.13) gazetted on 4 October 2016 (No. APVMA 20).

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 18, 2016) and (No. APVMA 20, 2016) 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 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 Government of Australia and the Government of New Zealand concerning a Joint Food Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.

Food Standards Australia New Zealand (FSANZ) made Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO) in relation to these variations and no comment was received in response to the notices.

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.


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]


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



Australia New Zealand Food Standards Code—

Schedule 20–Maximum residue limits Variation Instrument No. APVMA 1, 2017

I, Matthew O’Mullane, 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. Matthew O’Mullane Delegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority Dated this Fifth day of January 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 1, 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 1, 10 January 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

Agvet chemical: Niclosamide

Permitted residue: Niclosamide

Edible offal (mammalian) T*0.01 Eggs T*0.01 eat (mammalian) T*0.01 Milks T*0.01 Poultry, edible offal of T*0.01 Poultry meat T*0.01 Rice T*0.01

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

Agvet chemical: Cyproconazole Permitted residue: Cyproconazole, sum of isomers Chick-pea (dry) T*0.01 Lentil (dry) T*0.01

Agvet chemical: Dimethomorph

Permitted residue: Sum of E and Z isomers of dimethomorph Leafy vegetables [except lettuce, head] T10

Agvet chemical: Metribuzin

Permitted residue: Metribuzin Root and tuber vegetables [except potato]

T*0.05



Agvet chemical: Prothioconazole

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

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

Chick-pea (dry) T0.7 Lentil (dry) T0.7 Pulses [except chick-pea (dry); lentil (dry)]

T0.1

Agvet chemical: Tebuconazole

Permitted residue: Tebuconazole Broad bean (dry) T0.5 Chick-pea (dry) T0.2 Lentil (dry) T0.2

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

Agvet chemical: Azoxystrobin

Permitted residue: Azoxystrobin Broad bean (dry) (fava bean) T0.05 Field pea (dry) T0.05

Agvet chemical: Captan

Permitted residue: Captan Mandarins T3

Agvet chemical: Cyproconazole

Permitted residue: Cyproconazole, sum of isomers

Pulses T0.07

Agvet chemical: Cypermethrin

Permitted residue: Cypermethrin, sum of isomers

Fruiting vegetables, other than cucurbits [except sweet corn (corm on the cob); tomato]

T1



Agvet chemical: Emamectin

Permitted residue: Sum of emamectin B1a and emamectin B1b Podded pea (young pods) (snow and sugar snap)

T0.02

Agvet chemical: Metribuzin

Permitted residue: Metribuzin Carrot T0.3 Root and tuber vegetables [except carrot; potato]

T*0.05

Agvet chemical: Prothioconazole

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

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

Pulses T0.7

Agvet chemical: Tebuconazole

Permitted residue: Tebuconazole Pulses [except mung bean (dry); soya bean (dry)]

T1



Revocation of Suspension of a Product Containing Dimethoate to Allow Approval of New Label

On 12 December 2016 the APVMA revoked the suspension of the following dimethoate product registration to allow approval of a new product label that has instructions consistent with the previous suspension instructions as published on 6 October 2016 to mitigate the dietary risks identified in the review of dimethoate.

Table 1: Registered product containing dimethoate and new approved label

Product no. Product name Holder Label approval that remains suspended

New approved label number that is not suspended

63470 Was Country Dimethoate 400 Systemic Insecticide Name changed to Accensi Dimethoate 400 Systemic Insecticide

Accensi Pty Ltd

63470/1208 63470/107888

Please note that the label approval listed in Column 4 of Table 1 remains suspended. Product bearing this suspended label must continue to be used only in accordance with the instructions issued by the APVMA to allow continued use of suspended dimethoate products. See permit PER 13155 for the current instructions for the use of suspended dimethoate products and products bearing suspended labels. The new approved label listed in Column 5 of Table 1 may be used according to its label instructions.

FURTHER CHANGES TO INSTRUCTIONS FOR USE MAY BE REQUIRED

Please note that the review of all dimethoate products is ongoing and further changes to the status of registrations and the instructions for use of dimethoate products may be required prior to finalisation of the review.

APVMA CONTACT

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

Contact Officer Chemical Review Scientific Assessment and Chemical Review Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4749 Fax: +61 2 6210 4776 Email: [email protected]

Revocation of Suspension of a Product Containing Dimethoate to Allow Approval of New Label


apvma gazette no. 1, 10 january 2017 · no. apvma 1, tuesday, 10 january 2017 published by the...

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