APVMA Gazette No. 14, 16 July 2019



GazetteAgricultural andVeterinary ChemicalsNo. APVMA 14, Tuesday, 16 July 2019Published by the Australian Pesticides and Veterinary Medicines AuthorityThe 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 DATE \@ "yyyy" 2019This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and inquiries concerning reproduction and rights should be addressed to:Assistant Director, CommunicationsAustralian Pesticides and Veterinary Medicines AuthorityPO Box 6182 Kingston ACT 2604Email: communications@.au Website: .auGeneral InformationThe 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 subscriptionThe APVMA Gazette is published in electronic format only and is available from the APVMA website.If you would like to subscribe to receive email notification when a new edition is published, please complete the subscription form.APVMA ContactsFor enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6770 2300.For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.CONTENTS TOC \h \z \t "Gazette Section Heading,1,Gazette Heading 1,2" Agricultural Chemical Products and Approved Labels PAGEREF _Toc14080638 \h 4Veterinary Chemical Products and Approved Labels PAGEREF _Toc14080639 \h 11Approved Active Constituents PAGEREF _Toc14080640 \h 19Revocation of Suspension of Label Approvals containing 2,4-D to allow Approval of new Label PAGEREF _Toc14080641 \h 20Variations to Schedule 20 of the Australia New Zealand Food Standards Code PAGEREF _Toc14080642 \h 22Agricultural Chemical Products and Approved Labels Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.Agricultural Products Based on New Active ConstituentsApplication no.:110155Product name:Belanty FungicideActive constituent/s:75 g/L mefentrifluconazoleApplicant name:BASF Australia LtdApplicant ACN:008 437 867Summary of use:For the control of powdery mildew in grapes and black spot in applesDate of registration:24 June 2019Product registration no.:84344Label approval no.:84344/110155agricultural Products Based on Existing Active ConstituentsApplication no.:115102Product name:Farmalinx Creeper 800 WG FungicideActive constituent/s:800 g/kg carbendazimApplicant name:Farmalinx Pty LtdApplicant ACN:134 353 245Summary of use:For the control of fungal diseases in various cropsDate of registration:24 June 2019Product registration no.:86239Label approval no.:86239/115102Application no.:119639Product name:Take-Up Oil Spreader And WetterActive constituent/s:582 g/L paraffinic oil, 120g/L nonyl phenol ethoxylate, 120g/L alcohol ethoxylateApplicant name:Grow Choice Pty LimitedApplicant ACN:161 264 884Summary of use:To improve the spreading and wetting of herbicides, insecticides and defoliants on plant surfacesDate of registration:24 June 2019Product registration no.:87872Label approval no.:87872/119639Application no.:119895Product name:Thing 600 HerbicideActive constituent/s:600 g/L triclopyr present as the butoxyethyl esterApplicant name:Sunrise Crop Science Co LtdApplicant ACN:N/ASummary of use:For the control of various woody and broadleaf weedsDate of registration:26 June 2019Product registration no.:87955Label approval no.:87955/119895Application no.:119928Product name:F.S.A. Spray AdjuvantActive constituent/s:704 g/L methyl and ethyl esters of free fatty acids derived from refined canola oilApplicant name:Four Seasons Agribusiness Pty LtdApplicant ACN:115 133 189Summary of use:For use as a biodegradable penetrator adjuvant, to enhance the effectiveness of certain herbicides, pyrethroid insecticides, defoliants and desiccantsDate of registration:26 June 2019Product registration no.:87972Label approval no.:87972/119928Application no.:120004Product name:Eureka! Mancozeb 420 SC FungicideActive constituent/s:420 g/L mancozebApplicant name:Eureka! Agresearch Pty LtdApplicant ACN:086 194 738Summary of use:For the control of leaf spot and suppression of other diseases on bananas and control of fungal diseases of cucurbits, potatoes, tomatoes, almonds, grape vines, chickpeas, faba beans, lentils, oilseed poppy and turfDate of registration:26 June 2019Product registration no.:87997Label approval no.:87997/120004Application no.:114097Product name:Eureka! Imidacloprid Tebuconazole Flowable Seed TreatmentActive constituent/s:360 g/L imidacloprid, 12.5 g/L tebuconazoleApplicant name:Eureka! Agresearch Pty LtdApplicant ACN:086 194 738Summary of use:For the control of various insect pests and fungal diseases in a range of crops, protection against insect pests of stored cereal grains and the prevention of spread of barley yellow dwarf virus in cereal cropsDate of registration:26 June 2019Product registration no.:85809Label approval no.:85809/114097Application no.:119896Product name:Wolverine 700 HerbicideActive constituent/s:700 g/kg imazamoxApplicant name:Sunrise Crop Science Co LtdApplicant ACN:N/ASummary of use:For the post-emergence control of certain annual grass and broadleaf weeds in field peas, legume-based pastures, lucerne, peanuts and soybeansDate of registration:26 June 2019Product registration no.:87956Label approval no.:87956/119896Application no.:120023Product name:Hemani Alpha-Cypermethrin 100 EC InsecticideActive constituent/s:100 g/L alpha-cypermethrinApplicant name:Hemani Industries LimitedApplicant ACN:N/ASummary of use:For the control of insect pests of Cereals, Cotton, Grain Legumes, Oilseeds, Pastures, Pome and Stone Fruits, Rice, Trees & Ornamentals, Tobacco and VegetablesDate of registration:26 June 2019Product registration no.:88004Label approval no.:88004/120023Application no.:115980Product name:Topnotch FungicideActive constituent/s:200 g/L azoxystrobin, 200 g/L propiconazoleApplicant name:Adama Australia Pty LimitedApplicant ACN:050 328 973Summary of use:For control of various diseases in barley and wheatDate of registration:26 June 2019 Product registration no.:86531Label approval no.:86531/115980Application no.:117944Product name:Permethor Shield Liquid InsecticideActive constituent/s:500 g/L permethrinApplicant name:Ensystex Australasia Pty LtdApplicant ACN:102 221 965Summary of use:For control of a range of insect pests in various household and industrial situationsDate of registration:26 June 2019Product registration no.:87254Label approval no.:87254/117944Application no.:113510Product name:Soprano 500 FungicideActive constituent/s:500 g/L epoxiconazoleApplicant name:Adama Australia Pty LimitedApplicant ACN:050 328 973Summary of use:For the control of a range of fungal diseases in cereals and bananasDate of registration:5 July 2019Product registration no.:85527Label approval no.:85527/113510Application no.:114361Product name:International Micron 350 Premium Self Polishing AntifoulingActive constituent/s:Red 744 g/L copper as cuprous oxide, Blue 753 g/L copper as cuprous oxide, Navy 753 g/L copper as cuprous oxide, Black 739 g/L copper as cuprous oxide, Green 756g/L copper as cuprous oxide, Dark Grey 752g/L copper as cuprous oxideApplicant name:Akzo Nobel Pty LimitedApplicant ACN:000 119 424Summary of use:To control marine growth below the waterline on pleasure craftDate of registration:5 July 2019Product registration no.:86008Label approval no.:86008/114361Application no.:114667Product name:Contact Organics FarmSafe BoostActive constituent/s:350 g/L ammonium sulphateApplicant name:Contact Organics Pty LtdApplicant ACN:607 848 091Summary of use:Adjuvant for use in conjunction with Contact Organics FarmSafe Weed Terminator ConcentrateDate of registration:5 July 2019Product registration no.:86091Label approval no.:86091/114667Application no.:115497Product name:Viral Control SanitiserActive constituent/s:100 g/L quaternary ammonium compound, Includes: 18 g/L didecyldimethylammonium chlorideApplicant name:Aimix Chemicals Pty LtdApplicant ACN:003 382 607Summary of use:For use in sanitising poultry sheds, animal pens, and farm equipmentDate of registration:5 July 2019Product registration no.:86329Label approval no.:86329/115497Application no.:118934Product name:Contact Organics LocalSafe BoostActive constituent/s:350 g/L ammonium sulfateApplicant name:Contact Organics Pty LtdApplicant ACN:607 848 091Summary of use:For use in conjunction with Contact Organics LocalSafe Weed Terminator ConcentrateDate of registration:5 July 2019Product registration no.:87672Label approval no.:87672/118934Application no.:107720Product name:Ecocarb Plus FungicideActive constituent/s:633 g/kg potassium bicarbonate, 312 g/kg potassium silicateApplicant name:Organic Crop Protectants Pty LtdApplicant ACN:003 149 719Summary of use:For the control and suppression of various fungal infections in viticultural and horticultural crops as per the directions for use.Date of registration:8 July 2019Product registration no.:83204Label approval no.:83204/107720Listed RegistrationsApplication no.:120034Product name:Proguard Calcium Hypochlorite Tablets Pool Sanitiser & OxidiserActive constituent/s:700 g/kg available chlorine (Cl) present as calcium hypochloriteApplicant name:Biolab Australia Pty LtdApplicant ACN:005 878 017Summary of use:For the control of bacteria, viruses and algae in swimming poolsDate of registration:26 June 2019Product registration no.:88012Label approval no.:88012/120034Variations of registration Application no.:116875Product name:Sero-X InsecticideActive constituent/s:400g/L clitoria ternatea extractApplicant name:Innovate AG Pty LimitedApplicant ACN:099 056 952Summary of use:Variation of product registration and label approval to allow aerial application.Date of registration:24 June 2019Product registration no.:81070Label approval no.:81070/116875Application no.:119875Product name:Sk Enspray 99 A Food-grade Horticultural Spray Oil For 21st CenturyActive constituent/s:821 g/L paraffinic oilApplicant name:SBC Asia Pacific Pty LtdApplicant ACN:099 546 415Summary of use:To update signal heading, first aid instructions, safety direction and incompatibility statements on the labelDate of registration:24 June 2019Product registration no.:56574Label approval no.:56574/119875Application no.:114012Product name:Trivor InsecticideActive constituent/s:186 g/L acetamiprid, 124 g/L pyriproxyfenApplicant name:Adama Australia Pty LimitedApplicant ACN:050 328 973Summary of variation:Variation of label to extend uses to avocados, citrus, grapes, macadamias and mangoes for the control of various insect pestsDate of variation:26 June 2019Product registration no.:80807Label approval no.:80807/114012Application no.:120208Product name:Conquest Avalanche 750 WG HerbicideActive constituent/s:750 g/kg metribuzinApplicant name:Conquest Crop Protection Pty LtdApplicant ACN:098 814 932Summary of variation:To correct the scheduling and signal heading from Caution to PoisonDate of variation:27 June 2019Product registration no.:59030Label approval no.:59030/120208Application no.:119545Product name:Nufarm Bromicide 200 Selective HerbicideActive constituent/s:200 g/L bromoxynil present as the N-octanoylesterApplicant name:Nufarm Australia LimitedApplicant ACN:004 377 780Summary of variation:To add use as a tank mixture with Frequency Herbicide and to reformat the label to combine weeds and make it more streamlinedDate of variation:27 June 2019Product registration no.:31614Label approval no.:31614/119545Application no.:119712Product name:Fascinate 280 SL HerbicideActive constituent/s:280 g/L glufosinate-ammoniumApplicant name:UPL Australia LimitedApplicant ACN:066 391 384Summary of variation:To add uses to non-agricultural areas, forestry and in summer fallows against various weeds as per the directions for useDate of variation:27 June 2019Product registration no.:83459Label approval no.:83459/119712Application no.:116800Product name:Pyganic Organic InsecticideActive constituent/s:13 g/L pyrethrinsApplicant name:Sumitomo Chemical Australia Pty LimitedApplicant ACN:081 096 255Summary of variation:To add a range of crops and pests for use just prior (3 - 12 hours) to harvest; to alter the current rate for use in horticultural crops and to extend the use of to a range of crops against a range of insect pestsDate of variation:28 June 2019Product registration no.:59684Label approval no.:59684/116800Application no.:116582Product name:Seguris Flexi FungicideActive constituent/s:125 g/L isopyrazamApplicant name:Syngenta Australia Pty LtdApplicant ACN:002 933 717Summary of variation:To allow concentrate spraying in apples and pearsDate of variation:4 July 2019Product registration no.:80618Label approval no.:80618/116582Application no.:120775Product name:BioGuard Pacific Blue Power Tabs Pool SanitiserActive constituent/s:651 g/kg chlorine present as trichloroisocyanuric acid, 68 g/kg sodium tetraborate pentahydrateApplicant name:Biolab Australia Pty LtdApplicant ACN:005 878 017Summary of variation:To change the distinguishing product name and the name that appears on the label from Pool Sanitiser Pacific Blue Power Tabs to BioGuard Pacific Blue Power Tabs Pool SanitiserDate of variation:26 June 2019Product registration no.:53342Label approval no.:53342/120775Application no.:117723Product name:Austar Plant Growth RegulatorActive constituent/s:250 g/L paclobutrazolApplicant name:Chemicals Direct Pty LtdApplicant ACN:055 623 688Summary of variation:To replace the registered formulationDate of variation:5 July 2019Product registration no.:54791Label approval no.:54791/117723Application no.:118844Product name:Contact Organics LocalSafe Weed Terminator Concentrate HerbicideActive constituent/s:900 g/L acetic acid, 10 g/L hydrochloric acidApplicant name:Contact Organics Pty LtdApplicant ACN:607 848 091Summary of variation:To add a mix with Contact Organics LocalSafe BoostDate of variation:5 July 2019Product registration no.:85722Label approval no.:85722/118844Application no.:118676Product name:Butisan HerbicideActive constituent/s:500 g/L metazachlorApplicant name:BASF Australia LtdApplicant ACN:008 437 867Summary of variation:Variation of product registration and label approval to extend the use to include additional grass and broadleaved weed speciesDate of variation:5 July 2019Product registration no.:80664Label approval no.:80664/118676Application no.:118414Product name:Prosper 500 EC FungicideActive constituent/s:500 g/L spiroxamineApplicant name:Bayer Cropscience Pty LtdApplicant ACN:000 226 022Summary of variation:Set appropriate re-entry and WH&S recommendationsDate of variation:8 July 2019Product registration no.:52817Label approval no.:52817/118414Veterinary 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.Veterinary Products Based on Existing Active ConstituentsApplication no.:115796Product name:Semintra 10 mg/mL Oral Solution for CatsActive constituent/s:10 mg/mL telmisartanApplicant name:Boehringer Ingelheim Pty Limited, Vetmedica DivisionApplicant ACN:000 452 308Summary of use:For the treatment of hypertension in cats, and the reduction of proteinuria in cats with chronic kidney diseaseDate of registration:25 June 2019Product registration no.:86454Label approval no.:86454/115796Application no.:116050Product name:Theraspray 10 Iodophor Teat SanitiserActive constituent/s:10 g/L available iodineApplicant name:Ecolab Pty LimitedApplicant ACN:000 449 990Summary of use:For use as a teat dip or spray on dairy cows to aid in the control of mastitisDate of registration:25 June 2019Product registration no.:86564Label approval no.:86564/116050Application no.:118175Product name:Evicto For CatsActive constituent/s:60 mg/mL selamectinApplicant name:Virbac (Australia) Pty LtdApplicant ACN:003 268 871Summary of use:For treating and controlling flea infestations in cats, preventing heartworm disease in cats, treating ear mites in cats and rabbits, treating sarcoptic mange in rabbits, treating and controlling hookworm and roundworm in cats, treating biting lice in cats, and treating cheyletiellosis in rabbitsDate of registration:27 June 2019Product registration no.:87353Label approval no.:87353/118175Application no.:118176Product name:Evicto for Dogs 2.6-5kgActive constituent/s:120 mg/mL selamectinApplicant name:Virbac (Australia) Pty LtdApplicant ACN:003 268 871Summary of use:For treatment, prevention and control of flea infections, prevention of heartworm disease, treatment and control of ear mites and sarcoptic mange, and treatment of biting and suckling liceDate of registration:27 June 2019Product registration no.:87354Label approval no.:87354/118176Application no.:118177Product name:Evicto for Puppies and KittensActive constituent/s:60mg/mL selamectinApplicant name:Virbac (Australia) Pty LtdApplicant ACN:003 268 871Summary of use:For treating and controlling flea infestations in puppies and kittens, preventing heartworm disease in puppies and kittens, treating and controlling ear mites in puppies kittens and small rabbits, treating sarcoptic mange in puppies and small rabbits, treating and controlling hookworm and roundworm in kittens, treating lice in puppies and kittens, and treating cheyletiellosis in small rabbitsDate of registration:27 June 2019Product registration no.:87355Label approval no.:87355/118177Application no.:119203Product name:Evicto for Dogs 10.1 - 20kgActive constituent/s:120 mg/mL selamectinApplicant name:Virbac (Australia) Pty LtdApplicant ACN:003 268 871Summary of use:For treatment, prevention and control of flea infections, prevention of heartworm disease, treatment and control of ear mites and sarcoptic mange, and treatment of biting and suckling lice in dogs 10.1 - 20kgDate of registration:27 June 2019Product registration no.:87760Label approval no.:87760/119203Application no.:119204Product name:Evicto for Dogs 20.1 - 40kgActive constituent/s:120 mg/mL selamectinApplicant name:Virbac (Australia) Pty LtdApplicant ACN:003 268 871Summary of use:For treatment, prevention and control of flea infections, prevention of heartworm disease, treatment and control of ear mites and sarcoptic mange, and treatment of biting and suckling lice in dogs 20.1 - 40kgDate of registration:27 June 2019Product registration no.:87761Label approval no.:87761/119204Application no.:119205Product name:Evicto for Dogs 5.1 – 10kgActive constituent/s:120 mg/mL selamectinApplicant name:Virbac (Australia) Pty LtdApplicant ACN:003 268 871Summary of use:For treatment, prevention and control of flea infections, prevention of heartworm disease, treatment and control of ear mites and sarcoptic mange, and treatment of biting and suckling liceDate of registration:27 June 2019Product registration no.:87762Label approval no.:87762/119205Application no.:113561Product name:Fennec Pour-on for SheepActive constituent/s:300 mg/mL N-methylpyrrolidone, 35 mg/mL imidacloprid, 4 mg/mL abamectin, Applicant name:Boehringer Ingelheim Animal Health Australia Pty LtdApplicant ACN:071 187 285Summary of use:For the treatment and control of susceptible strains of lice (Bovicola ovis) and abamectin susceptible gastrointestinal nematodes in sheepDate of registration:27 June 2019Product registration no.:85544Label approval no.:85544/113561Application no.:118030Product name:Element Injectable Trace Mineral with Vitamin B12 for CattleActive constituent/s:26.7 g/L zinc as disodium zinc EDTA, 10 g/L copper as disodium copper EDTA, 6.7 g/L manganese as disodium manganese EDTA, 3.3 g/L selenium as sodium selenite, 1.4 g/L cyanocobalaminApplicant name:Boehringer Ingelheim Animal Health Australia Pty LtdApplicant ACN:071 187 285Summary of use:For Beef and Dairy Cattle deficient in and/or responsive to copper, manganese, zinc, selenium and/or vitamin B12 supplementationDate of registration:28 June 2019Product registration no.:87283Label approval no.:87283/118030Application no.:118034Product name:Element Injectable Trace Mineral, Copper Free for Cattle & SheepActive constituent/s:26.7 g/L zinc as disodium zinc EDTA, 6.7 g/L manganese as disodium manganese EDTA, 3.3 g/L selenium as sodium selenite, 1.4 g/L cyanocobalaminApplicant name:Boehringer Ingelheim Animal Health Australia Pty LtdApplicant ACN:071 187 285Summary of use:For sheep, beef and dairy cattle deficient in and/or responsive to manganese, zinc, selenium and/or vitamin B12 supplementationDate of registration:28 June 2019Product registration no.:87286Label approval no.:87286/118034Application no.:117796Product name:Revolution Plus (selamectin/sarolaner) Monthly Topical Solution for Small Cats and Kittens 1.25 – 2.5 kgActive constituent/s:60 mg/mL selamectin, 10 mg/mL sarolanerApplicant name:Zoetis Australia Pty LtdApplicant ACN:156 476 425Summary of use:For registration of a 60 mg/mL selamectin and 10 mg/mL sarolaner topical solution for the treatment and control of endoparasites and ectoparasites in small cats and kittens catsDate of registration:1 July 2019Product registration no.:87225Label approval no.:87225/117796Application no.:117793Product name:Revolution Plus (selamectin/sarolaner) Monthly Topical Solution for Large Cats 5.1 – 10 kgActive constituent/s:60 mg/mL selamectin, 10 mg/mL sarolanerApplicant name:Zoetis Australia Pty LtdApplicant ACN:156 476 425Summary of use:For registration of a 60 mg/mL selamectin and 10 mg/mL sarolaner topical solution for the treatment and control of endoparasites and ectoparasites in large catsDate of registration:1 July 2019Product registration no.:87222Label approval no.:87222/117793Application no.:117795Product name:Revolution Plus (selamectin/sarolaner) Monthly Topical Solution for Medium Cats 2.6 – 5 kgActive constituent/s:60 mg/mL selamectin, 10 mg/mL sarolanerApplicant name:Zoetis Australia Pty LtdApplicant ACN:156 476 425Summary of use:For registration of a 60 mg/mL selamectin and 10 mg/mL sarolaner topical solution for the treatment and control of endoparasites and ectoparasites in large catsDate of registration:1 July 2019Product registration no.:87224Label approval no.:87224/117795Application no.:116204Product name:Equimox GelActive constituent/s:125 mg/mL praziquantel, 20 mg/mL moxidectinApplicant name:Abbey Laboratories Pty LtdApplicant ACN:156 000 430Summary of use:For the treatment and prevention of tapeworm, large strongyles, small strongyles, pinworms, ascarids, hairworms, intestinal threadworms, stomach worms, bots and cutaneous onchocerciasisDate of registration:3 July 2019Product registration no.:86613Label approval no.:86613/116204Application no.:120014Product name:Flyban Spray-on Sheep Blowfly TreatmentActive constituent/s:50 g/L dicyclanilApplicant name:The Hunter River Company Pty LimitedApplicant ACN:133 798 615Summary of variation:To approve a new label for the product 'FLYBAN SPRAY-ON SHEEP BLOWFLY TREATMENT' with the label name ''INDEPENDENTS OWN FLYK SPRAY-ON SHEEP BLOWFLY TREATMENT”Date of variation:5 July 2019Product registration no.:83154Label approval no.:83154/120014Variations of registration Application no.:119611Product name:Doxy 100 Antibiotic TabletsActive constituent/s:100 mg/Tb doxycycline (as monohydrate)Applicant name:Dechra Veterinary Products (Australia) Pty LtdApplicant ACN:614 716 700Summary of variation:To change the distinguishing name and the name on the label from “DOXYCYCLINE 100 ANTIBIOTIC TABLETS” to “DOXY 100 ANTIBIOTIC TABLETS”, and to update the relevant label particulars in line with the current Vet Labelling CodeDate of variation:27 June 2019Product registration no.:56206Label approval no.:56206/119611Application no.:119825Product name:Ilium Meloxicam 20 Anti-inflammatory Injection for Cattle, Pigs and HorsesActive constituent/s:20 mg/mL meloxicamApplicant name:Troy Laboratories Pty LtdApplicant ACN:000 283 769Summary of variation:To change the distinguishing product name and the name on the label from ILIUM MELOXICAM 20 ANTI-INFLAMMATORY INJECTION FOR CATTLE AND PIGS to ILIUM MELOXICAM 20 ANTI-INFLAMMATORY INJECTION FOR CATTLE, PIGS AND HORSES, to add a claim for horse, and to update the relevant label particulars in line with the current Vet Labelling CodeDate of variation:28 June 2019Product registration no.:62535Label approval no.:62535/119825variation of label approvalApplication no.:120667Product name:Independents Own Venus Liquid Sheep Blowfly TreatmentActive constituent/s:500 g/L cyromazineApplicant name:Australian Independent Rural Retailers Pty LtdApplicant ACN:112 308 835Summary of variation:To change the distinguishing product name and the name that appears on the label from Venus Liquid Sheep Blowfly Treatment to Independents Own Venus Liquid Sheep Blowfly TreatmentDate of variation:18 June 2019Product registration no.:53023Label approval no.:53023/120667Application no.:120652Product name:Independents Own Venus Spray-On Sheep Blowfly TreatmentActive constituent/s:60 g/L cyromazineApplicant name:Australian Independent Rural Retailers Pty LtdApplicant ACN:112 308 835Summary of variation:To change the distinguishing product name and the name that appears on the label from Venus Spray-On Sheep Blowfly Treatment to Independents Own Venus Spray-On Sheep Blowfly TreatmentDate of variation:18 June 2019Product registration no.:52745Label approval no.:52745/120652Application no.:120668Product name:Eprimec Pour-On For CattleActive constituent/s:5 mg/mL eprinomectinApplicant name:Abbey Laboratories Pty LtdApplicant ACN:156 000 430Summary of variation:To change the distinguishing product name and the name that appears on the label from Eprimax Pour-On For Cattle to Eprimec Pour-On For CattleDate of variation:19 June 2019Product registration no.:86741Label approval no.:86741/120668Application no.:120766Product name:Neoprinil Pour-On for Beef and Dairy CattleActive constituent/s:5 mg/ml eprinomectinApplicant name:Virbac (Australia) Pty LtdApplicant ACN:003 268 871Summary of variation:To change the distinguishing product name and the name that appears on the label from Neoprinil Pour-On for Beef and Dairy Cattle and Deer to Neoprinil Pour-On for Beef and Dairy CattleDate of variation:25 June 2019Product registration no.:84602Label approval no.:84602/120766Application no.:120803Product name:Ovastim Injection For SheepActive constituent/s:600 mg/L polyandroalbuminApplicant name:Virbac (Australia) Pty LtdApplicant ACN:003 268 871Summary of variation:To update the current approved label to remove a use from the instructions for use of the product Ovastim Injection for Sheep, and to create an eLabel, in line with the Vet labelling CodeDate of variation:27 June 2019Product registration no.:51133Label approval no.:51133/120803Application no.:120000Product name:Moxiclear for Dogs Over 25 kgActive constituent/s:100 g/L imidacloprid, 25 g/L moxidectinApplicant name:Norbrook Laboratories Australia Pty LimitedApplicant ACN:080 972 596Summary of variation:To amend the relevant label particulars in the Dosage and Administration and General Directions sectionsDate of variation:5 July 2019Product registration no.:83622Label approval no.:83622/120000Application no.:120018Product name:Moxiclear for Kittens and Small Cats up to 4 kgActive constituent/s:100 g/L imidacloprid, 10 g/L moxidectinApplicant name:Norbrook Laboratories Australia Pty LimitedApplicant ACN:080 972 596Summary of variation:To amend the relevant label particulars in the Dosage and Administration and General Directions sectionsDate of variation:5 July 2019Product registration no.:83601Label approval no.:83601/120018Application no.:120021Product name:Moxiclear for Cats Over 4 kgActive constituent/s:100 g/L imidacloprid, 10 g/L moxidectinApplicant name:Norbrook Laboratories Australia Pty LimitedApplicant ACN:080 972 596Summary of variation:To amend the relevant label particulars in the Dosage and Administration and General Directions sectionsDate of variation:5 July 2019Product registration no.:83604Label approval no.:83604/120021Application no.:119980Product name:Moxiclear for Puppies and Small Dogs up to 4 kgActive constituent/s:100 g/L imidacloprid, 25 g/L moxidectinApplicant name:Norbrook Laboratories Australia Pty LimitedApplicant ACN:080 972 596Summary of variation:To amend the relevant label particulars in the Dosage and Administration and General Directions sectionsDate of variation:5 July 2019Product registration no.:83619Label approval no.:83619/119980Application no.:119996Product name:Moxiclear for Dogs 4-10 kgActive constituent/s:100 g/L imidacloprid, 25 g/L moxidectinApplicant name:Norbrook Laboratories Australia Pty LimitedApplicant ACN:080 972 596Summary of variation:To amend the relevant label particulars in the Dosage and Administration and General Directions sectionsDate of variation:5 July 2019Product registration no.:83620Label approval no.:83620/119996Application no.:119999Product name:Moxiclear for Dogs 10-25 kgActive constituent/s:100 g/L imidacloprid, 25 g/L moxidectinApplicant name:Norbrook Laboratories Australia Pty LimitedApplicant ACN:080 972 596Summary of variation:To amend the relevant label particulars in the Dosage and Administration and General Directions sectionsDate of variation:5 July 2019Product registration no.:83621Label approval no.:83621/119999Approved Active ConstituentsPursuant 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.active constituentApplication no.:117550Active constituent/s:pyriproxyfenApplicant name:Foison Scitech Co LimitedApplicant ACN:N/ASummary of use:For use in agricultural chemical productsDate of approval:27 June 2019Approval no.:87099Application no.:113869Active constituent/s:beauveria bassiana strain PPRI 5339Applicant name:BASF Australia LtdApplicant ACN:008 437 867Summary of use:For use in agricultural chemical productsDate of approval:8 July 2019Approval no.:85695Revocation of Suspension of Label Approvals containing 2,4-D to allow Approval of new LabelOn 3 July 2019 the APVMA revoked the suspension of the following 2,4-D product label approvals to allow approval of a new product label that has instructions consistent with the previous suspension instructions as published in 2018.Table 1:Registered products containing 2,4-D and new approved labels1.Product No2.Product Name3.Registrant4.Label Approvals that have been cancelled5.New approved Label Number that is not suspended67109Kenso Agcare Bucko 75-D Herbicide Kenso Corporation (M) Sdn. Bhd67109/5522667109/11837256339Kenso Agcare Ken-Amine 625 Selective Herbicide Kenso Corporation (M) Sdn. Bhd56339/031056339/11894868049Ezycrop 2,4-D IPA 300 HerbicideEzycrop Pty Ltd68049/5735768049/5980368049/11832968558Ezycrop 2,4-D Amine 625 HerbicideEzycrop Pty Ltd68558/5857268558/11823885354Kojak 75D HerbicideCrop Culture Pty Ltd85354/11299685354/11815764728Agro-Essence 2,4-D 625SLAgro-Alliance (Australia) Pty Ltd64728/5344364728/11803767615Agro-Essence 2,4-D Ester 680 HerbicideAgro-Alliance (Austrlia) Pty Ltd67615/5646467615/11803867261Agro-Essence 2,4-D 300 HerbicideAgro-Alliance (Austrlia) Pty Ltd67261/5564367621/11803684835Submarino 2,4-D Amine 625 HerbicideSubmarino Pty Ltd84835/11152884835/11801768480Agmate 2,4-D 625 SL HerbicideAgcare Pty Ltd68480/5842968480/11800968475Agmate 2,4-D 300 SL HerbicideAgcare Pty Ltd68475/5842468475/11800856719Titan Amine 625 Selective HerbicideTitan Ag Pty Ltd 56719/021456719/11792970018Kelpie Amine 625 HerbicideSinochem International Australia Pty Ltd70018/6231270018/11785431536Campbell Methar Tri-Kombi Hebicide Colin Campbell (Chemicals) Pty Ltd31536/5717631536/11771663813Putra-Amine 625 Selective Herbicide Hextar Chemicals Pty Ltd 63813/5954363813/11757265224Kenso Agcare Ken-Ester LV 680 Selective Herbicide Kenso Corporation ( M) Sdn. Bhd. 65224/5045365224/11942665638Kenso Agcare Ken-Amine 720 Selective Herbicide Kenso Corporation ( M) Sdn. Bhd. 65638/021465638/5148254950Kenso Agcare Ken-Star 300 HerbicideKenso Corporation ( M) Sdn. Bhd.54950/021454950/080554950/11925768049Ezycrop 2,4-D IPA 300 HerbicideEzycrop Pty Ltd68409/5735768409/5980368049/11832968558Ezycrop 2,4-D Amine 625 HerbicideEzycrop Pty Ltd68558/5857268558/11832863412Titan LV Ester 680 herbicide Titan Ag Pty Ltd 63412/021463412/117927The suspension of the above label approvals listed in Table 1 has been revoked to allow the approval of new labels with instructions consistent with those issued by the APVMA.APVMA ContactFor any enquiries for or further information about this matter, please contact:Contact OfficerChemical ReviewAustralian Pesticides and Veterinary Medicines AuthorityPO Box 6182KINGSTON ACT 2604Phone:(02) 6770 2400Email:chemicalreview@.auVariations to Schedule 20 of the Australia New Zealand Food Standards CodeThe 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. 3) gazetted on 9 April 2019 (No. APVMA 7).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 4, 2019) 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 .au.Based on dietary exposure assessments and current health standards, the APVMA and Food Standards Australia and New Zealand (FSANZ) are satisfied that these MRLs are not harmful to public health. MRLs contained in Schedule 20 provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this means, Schedule 20 permits the sale of treated foods and protects public health by minimising residues in foods consistent with the effective control of pests and diseases.The agreement between the Australian Government and the New Zealand Government concerning a Joint Food Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.Food Standards Australia New Zealand (FSANZ) made Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO) in relation to these variations and no comment was received in response to that notice.A copy of these variations have been given to FSANZ.The variations take effect as from the date of this notice.This notice is published in accordance with subsection 82(7) of the Food Standards Australia New Zealand Act 1991. For further information please contact:MRL Contact Officer Australian Pesticides and Veterinary Medicines AuthorityPO Box 6182KINGSTON ACT 2604Phone:+61 2 6770 2300Email:enquiries@.auAustralia New Zealand Food Standards Code—Schedule 20—Maximum residue limits Variation Instrument No. APVMA 4, 2019I, Jason Lutze, Executive Director, Risk Assessment Capability 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.Jason LutzeDelegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines AuthorityDated this Eighth day of July 2019Part 1Preliminary1Name of instrument This instrument is the Australia New Zealand Food Standards Code—Schedule 20maximum residue limits Variation Instrument No. APVMA 4, 2019.2CommencementIn 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.3ObjectThe object of this instrument is for the APVMA to make variations to Schedule 20Maximum residue limits in the Australia New Zealand Food Standards Code to include or change maximum residue limits pertaining to agricultural and veterinary chemical products.4InterpretationIn this instrument: —APVMA means the Australian Pesticides and Veterinary Medicines Authority established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; andPrincipal Instrument means Schedule 20 Maximum residue limits in the Australia New Zealand Food Standard Code as defined in Section 4 of the Food Standards Australia New Zealand Act 1991 being the Code published in Gazette No. P 27 on 27 August 1987 together with any amendments of the standards in that Code. Schedule 20 was published in the Food Standards Gazette FSC 96 on Thursday 10 April 2015 and was registered as a legislative instrument on 1 April 2015 (F2015L00468).Part 2Variations to Schedule 20—Maximum Residue Limits 5Variations to Schedule 20The Schedule to this instrument sets out the variations made to the Principal Instrument by this instrument.ScheduleVariations to Schedule 20–Maximum residue limits [1]The table to section S20–3 in Schedule 20 is varied by[1.1]omitting from each of the following chemicals, the foods and associated MRLs Agvet chemical: GlyphosatePermitted residue: Sum of glyphosate, N-acetyl-glyphosate and aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosateOilseed [except cotton seed; peanut; linseed; poppy seed; rape seed (canola); sunflower seed]T*0.01Agvet chemical: PraziquantelPermitted residue: PraziquantelTunaT*0.01[1.2]inserting for each of the following chemicals the foods and associated MRLs in alphabetical orderAgvet chemical: BromoxynilPermitted residue: BromoxynilAll other foods except animal food commodities0.1HempseedT*0.02Agvet chemical: ChlorantraniliprolePermitted residue—plant commodities and animal commodities other than milk: ChlorantraniliprolePermitted residue—milk: Sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliproleHempseedT1Sesame seedT0.5Agvet chemical: DiflubenzuronPermitted residue—DiflubenzuronFish muscleT*0.002Agvet chemical: FluopyramPermitted residue—commodities of plant origin: FluopyramPermitted residue—commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyramEggs*0.02Poultry, Edible offal of*0.02Poultry meat*0.02Agvet chemical: GlyphosatePermitted residue: Sum of glyphosate, N-acetyl-glyphosate and aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosateOilseed [except cotton seed; peanut; linseed; poppy seed; rape seed (canola); sesame seed; sunflower seed]T*0.01Sesame seedT20Agvet chemical: HaloxyfopPermitted residue: Sum of haloxyfop, its esters and conjugates, expressed as haloxyfopHempseedT0.1Agvet chemical: IndoxacarbPermitted residue: Sum of indoxacarb and its R-isomerHempseedT*0.05Agvet chemical: MandestroninPermitted residue: MandestroninBeans, except broad bean and soya bean0.7Edible offal (Mammalian)0.02Lettuce, Head0.7Lettuce, Leaf7Meat (mammalian) (in the fat)0.02Milk*0.02Beans, except broad bean and soya bean0.7Agvet chemical: PraziquantelPermitted residue: PraziquantelFish muscleT*0.02Agvet chemical: Pyrethrins Permitted residue: Sum of pyrethrins i and ii, Cinerinsi i and ii and jasmolins i and ii, determined after calibration by means of the International Pyrethrum StandardAll other foods except animal food commodities0.2Edible offal (Mammalian)*0.05Eggs*0.05Meat (mammalian) (in the fat)*0.05Milks*0.05Poultry, Edible offal of*0.05Poultry, Meat (in the fat)*0.05Agvet chemical: SethoxydimPermitted residue: Sum of sethoxydim and metabolites containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulfoxides and sulfones, expressed as sethoxydimSesame seedT0.5Agvet chemical: TrichlorfonPermitted residue: TrichlorfonAll other foods except animal food commodities0.05Fish muscleT*0.01[1.3]omitting for each of the following chemicals, the maximum residue limit for the food and substitutingAgvet chemical: FluopyramPermitted residue—commodities of plant origin: FluopyramPermitted residue—commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyramEdible offal (Mammalian0.5Meat (mammalian)0.1Rape seed (canola seed)*0.01 ................
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