APVMA Gazette No. 09, 05 May 2020



GazetteAgricultural andVeterinary ChemicalsNo. APVMA 9, Tuesday, 5 May 2020Published 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" 2020This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and inquiries concerning reproduction and rights should be addressed to:Assistant Director, CommunicationsAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001Email: communications@.auWebsite: .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 _Toc39233848 \h 4Veterinary Chemical Products and Approved Labels PAGEREF _Toc39233849 \h 11Approved Active Constituents PAGEREF _Toc39233850 \h 16New agricultural active constituent: metcamifen PAGEREF _Toc39233851 \h 17New chemical product: EPIVIO C Sorghum Seed Safener containing metcamifen PAGEREF _Toc39233852 \h 19Change to conditions for the export of phorate PAGEREF _Toc39233853 \h 21Agricultural Chemical Products and Approved Labels Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.agricultural Products Based on Existing Active ConstituentsApplication no.:123645Product name:Choice Methomyl 225 InsecticideActive constituent/s:225 g/L methomylApplicant name:Grow Choice Pty LtdApplicant ACN:161 264 884Summary of use:For the control of insect pests in various cropsDate of registration:14 April 2020Product registration no.:89112Label approval no.:89112/123645Application no.:121354Product name:Sundew Household Flea Spray With FragranceActive constituent/s:0.125 g/L imidaclopridApplicant name:Sundew Solutions Pty LtdApplicant ACN:135 400 261Summary of use:To control fleas on carpets, pet bedding, and surrounding areasDate of registration:14 April 2020Product registration no.:88446Label approval no.:88446/121354Application no.:123265Product name:Superway Grub, Ant And Pest ControllerActive constituent/s:100 g/L bifenthrinApplicant name:Pooma Fertilizers Pty LtdApplicant ACN:625 414 164Summary of use:For the control of a range of pests in turf and ornamental plants. For the control of a wide range of interior and exterior pests. For the control of ants, lawn grub/army worm, African black beetle by forming residual surface treatments on a range of urban Interior and exterior situationsDate of registration:16 April 2020Product registration no.:89025Label approval no.:89025/123265Application no.:118825Product name:Imtrade Iconix 500 EC HerbicideActive constituent/s:500 g/L ioxynil present as the octanoateApplicant name:Imtrade Australia Pty LtdApplicant ACN:090 151 134Summary of use:For the control of certain broadleaf weeds in onion cropsDate of registration:17 April 2020Product registration no.:87625Label approval no.:87625/118825Application no.:122668Product name:Jarrah FungicideActive constituent/s:250 g/L triadimenolApplicant name:Turf Culture Pty LtdApplicant ACN:117 986 615Summary of use:For control of fungal diseases in a variety of crops and turfDate of registration:17 April 2020Product registration no.:88848Label approval no.:88848/122668Application no.:121408Product name:AC Carfentrazone 400 HerbicideActive constituent/s:400 g/L carfentrazone-ethylApplicant name:Axichem Pty LtdApplicant ACN:131 628 594Summary of use:For improvement in the control of marshmallow and certain other broadleaf weeds prior to establishment of broadacre crops, fallows or forest plantations, in commercial, industrial and public service areas, around agricultural buildings and yards, in tree fruits, nuts, grape vines in tank mixture with knockdown herbicides; control of marshmallow and annual nettles in grass pastures and rough grass/turf areas; and control of volunteer cotton seedlings including Roundup Ready cotton and desiccation of cotton re-growthDate of registration:17 April 2020Product registration no.:88478Label approval no.:88478/121408Application no.:123757Product name:Relyon Triple HerbicideActive constituent/s:250 g/L MCPA present as the ethyl hexyl ester, 250 g/L bromoxynil present as the octanoate, and 25 g/L diflufenicanApplicant name:Ruralco Holdings LimitedApplicant ACN:009 660 879Summary of use:For the control of certain broadleaf weeds in wheat, barley, triticale and cereal ryeDate of registration:20 April 2020Product registration no.:89151Label approval no.:89151/123757Application no.:123755Product name:Multicrop Take Root Plant Rooting Liquid Active constituent/s:4 g/L indole butyric acidApplicant name:Multicrop (Aust) Pty LtdApplicant ACN:001 102 889Summary of use:For striking and accelerating roots on most plant cuttingsDate of registration:20 April 2020Product registration no.:89150Label approval no.:89150/123755Application no.:121211Product name:Imtrade Spire 500 EC FungicideActive constituent/s:500g/L spiroxamineApplicant name:Imtrade Australia Pty LtdApplicant ACN:090 151 134Summary of use:For the control of powdery mildew in grapevinesDate of registration:22 April 2020Product registration no.:88400Label approval no.:88400/121211Application no.:121556Product name:4Farmers Fipronil 500 Insecticidal Seed TreatmentActive constituent/s:500 g/L FipronilApplicant name:4 Farmers Australia Pty Ltd Applicant ACN:160 092 428 Summary of use:For the control of various pests in canola, rice, sorghum, and sunflowers and to protect seedlings from attack from black field earwig in sorghum and sunflowersDate of registration:22 April 2020Product registration no.:88511Label approval no.:88511/121556Application no.:123796Product name:Apparent TebuPro 420SC FungicideActive constituent/s:210 g/L prothioconazole, 210 g/L tebuconazoleApplicant name:Titan Ag Pty LtdApplicant ACN:122 081 574Summary of use:For the control of various diseases in wheat, barley, oats, triticale, canola and pyrethrumDate of registration:23 April 2020Product registration no.:89161Label approval no.:89161/123796Application no.:120815Product name:Clearout Plus IGR Crawling Insect SprayActive constituent/s:0.5 g/kg fipronil and 0.15 g/kg pyriproxyfenApplicant name:Sherwood Chemicals Australasia Pty LtdApplicant ACN:136 993 630Summary of use:For the control of ants and cockroaches in domestic, commercial, and public buildingsDate of registration:23 April 2020Product registration no.:88298Label approval no.:88298/120815Application no.:123647Product name:Sinon Dicast InsecticideActive constituent/s:27.5 g/L deltamethrinApplicant name:Sinon Australia Pty LimitedApplicant ACN:102 741 024Summary of use:For the control of heliothis and other specified pests on cotton and other cropsDate of registration:24 April 2020Product registration no.:89113Label approval no.:89113/123647Application no.:120770Product name:Quali-Pro Negate HerbicideActive constituent/s:200 g/kg metsulfuron-methyl, 167 g/kg rimsulfuronApplicant name:ADAMA Australia Pty LimitedApplicant ACN:050 328 973Summary of use:For the control of winter grass, ryegrass, onion weed, and certain broadleaf weeds in couch and couch hybrids, zoysia, and Queensland Blue CouchDate of registration:27 April 2020Product registration no.:88290Label approval no.:88290/120770Variations of registrationApplication no.:124855Product name:Yates Grub Kill & Protect For Lawns Up To 6 Months Protection Against Curl GrubActive constituent/s:2 g/kg chlorantraniliproleApplicant name:Syngenta Australia Pty LtdApplicant ACN:002 933 717Summary of variation:To vary the distinguishing product name and the name that appears on the label from ‘Yates Grub Shield kills & protects against lawn grubs for up to 6 months granular’ to ‘Yates Grub Kill & Protect for Lawns up to 6 Months Protection Against Curl Grub’Date of variation:9 April 2020Product registration no.:88464Label approval no.:88464/124855Application no.:124905Product name:Fascinate Dry HerbicideActive constituent/s:500 g/kg glufosinate-ammoniumApplicant name:UPL Australia Pty LtdApplicant ACN:066 391 384Summary of variation:To vary the distinguishing product name and the name that appears on the label from ‘Fascinate 500 SG Herbicide’ to ‘Fascinate Dry Herbicide’Date of variation:9 April 2020Product registration no.:85197Label approval no.:85197/124905Application no.:124925Product name:Artemis Opti SpreaderActive constituent/s:1020 g/L polyether modified polysiloxaneApplicant name:Liquid Fertiliser Pty LtdApplicant ACN:105 456 148Summary of variation:To vary the distinguishing product name and the name that appears on the label from ‘Atremis Opti Spreader’ to ‘Artemis Opti Spreader’Date of variation:16 April 2020Product registration no.:88837Label approval no.:88837/124925Application no.:124963Product name:Raid Earth Options Botanicals Multi Insect KillerActive constituent/s:16.1 g/kg piperonyl butoxide, 3.5 g/kg pyrethrinApplicant name:S.C. Johnson & Son Pty LtdApplicant ACN:000 021 009Summary of variation:To vary the distinguishing product name and the name that appears on the label from ‘Raid Botanicals Multi Insect Killer’ to ‘Raid Earth Options Botanicals Multi Insect Killer’Date of variation:16 April 2020Product registration no.:69287Label approval no.:69287/124963Application no.:124964Product name:Raid Earth Options Botanicals Automatic Advanced Multi-Insect Control SystemActive constituent/s:45 g/kg piperonyl butoxide, 9 g/kg pyrethrinApplicant name:S.C. Johnson & Son Pty LtdApplicant ACN:000 021 009Summary of variation:To vary the distinguishing product name and the name that appears on the label from ‘Raid Botanicals Automatic Advanced Multi-Insect Control System’ to ‘Raid Earth Options Botanicals Automatic Advanced Multi-Insect Control System’Date of variation:16 April 2020Product registration no.:69288Label approval no.:69288/124964Application no.:118078Product name:Amistar Xtra FungicideActive constituent/s:200 g/L azoxystrobin, 80 g/L cyproconazoleApplicant name:Syngenta Australia Pty LtdApplicant ACN:002 933 717Summary of variation:To add uses in new cereal crops and extend uses to new diseases in wheat and barleyDate of variation:17 April 2020Product registration no.:57949Label approval no.:57949/118078Application no.:121557Product name:Metman 720 WG Systemic and Protective Fungicide Active constituent/s:640 g/kg mancozeb, 80 g/kg metalaxyl Applicant name:Agria S.A.Applicant ACN:N/ASummary of variation:To add uses in poppies and to extend the product shelf lifeDate of variation:21 April 2020Product registration no.:86145Label approval no.:86145/121557Application no.:122682Product name:F.S.A. Propyzamide 500 SC HerbicideActive constituent/s:500 g/l propyzamide, 42 g/L mono ethylene glycolApplicant name:Four Seasons Agribusiness Pty LtdApplicant ACN:115 133 189Summary of variation:To add uses in canola and to vary the pack size rangeDate of variation:22 April 2020Product registration no.:87920Label approval no.:87920/122682Application no.:123800Product name:Flupron 745 Herbicide Active constituent/s:745 g/L flupropanate present as the sodium salt Applicant name:Ruralco Holdings LimitedApplicant ACN:009 660 879Summary of variation:To add use in tea tree for control of giant Parramatta grassDate of variation:24 April 2020Product registration no.:81889Label approval no.:81889/123800Application no.:123798Product name:Overture FungicideActive constituent/s:125 g/L epoxiconazoleApplicant name:Sipcam Pacific Australia Pty LtdApplicant ACN:073 176 888Summary of variation:To add uses in wheat and barley when tank mixed with 250 g/L azoxystrobin productsDate of variation:27 April 2020Product registration no.:63994Label approval no.:63994/123798variation of label approvalApplication no.:124037Product name:Multicrop Multiguard Snail And Slug KillerActive constituent/s:60 g/kg iron edta complexApplicant name:Multicrop (Aust) Pty LtdApplicant ACN:001 102 889Summary of variation:Removing claim the product is pet friendlyDate of variation:14 April 2020Product registration no.:50312Label approval no.:50312/124037Application no.:124211Product name:Aquapro Pro-Knockout For PoolsActive constituent/s:700 g/kg available chlorine (CI) present as calcium hypochloriteApplicant name:M I International Pty LtdApplicant ACN:002 869 089Summary of variation:To approve a new label for the product 'Aquapro Pro-Knockout for Pools' with the label name ‘Clearchem Knockout for Pools'Date of variation:22 April 2020Product registration no.:62083Label approval no.:62083/124211Application no.:124214Product name:Aquapro Pure-Chlor For PoolsActive constituent/s:810 g/kg available chlorine (CI) present as trichloroisocyanuric acid, 100 g/kg sodium tetraborate pentahydrateApplicant name:M I International Pty LtdApplicant ACN:002 869 089Summary of variation:To approve a new label for the product 'Aquapro Pure-Chlor For Pools' with the label name 'Clearchem Premium Granular Chlorine For Pools'Date of variation:22 April 2020Product registration no.:62079Label approval no.:62079/124214Application no.:124215Product name:Aquapro Pro-Instant For PoolsActive constituent/s:720 g/kg available chlorine (CI) present as trichloroisocyanuric acid and sodium dichloroisocyanurateApplicant name:M I International Pty LtdApplicant ACN:002 869 089Summary of variation:To approve a new label for the product 'Aquapro Pro-Instant For Pools' with the label name 'Clearchem Insta Shock For Pools'Date of variation:22 April 2020Product registration no.:62088Label approval no.:62088/124215Application no.:124216Product name:Aquapro Dyna-Chlor For PoolsActive constituent/s:560 g/kg available chlorine present as sodium dichloroisocyanurateApplicant name:M I International Pty LtdApplicant ACN:002 869 089Summary of variation:To approve a new label for the product 'Aquapro Dyna-Chlor For Pools' with the label name ‘Clearchem Stabilised Pool Chlorine'Date of variation:22 April 2020Product registration no.:62090Label approval no.:62090/124216Application no.:124217Product name:Aquapro Dyna-Chlor Tabs For PoolsActive constituent/s:900 g/kg available chlorine present as trichloroisocyanuric acidApplicant name:M I International Pty LtdApplicant ACN:002 869 089Summary of variation:To approve a new label for the product ‘Aquapro Dyna-Chlor Tabs’ with the label name Clearchem Stabilised Chlorine TabsDate of variation:22 April 2020Product registration no.:62089Label approval no.:62089/124217Application no.:123831Product name:Evershield Seed TreatmentActive constituent/s:360g/L thiram, 200 g/L thiabendazole Applicant name:Arysta Lifescience Australia Pty Ltd Applicant ACN:005 225 507Summary of variation:To update the safety directions and first aid instructions in line with the FAISD handbookDate of variation:27 April 2020Product registration no.:65237Label approval no.:65237/123831Veterinary 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 New Active ConstituentsApplication no.:105030Product name:Dermcare Barazone 0.25 g/L Budesonide Leave-On ConditionerActive constituent/s:0.25 g/L budesonideApplicant name:Dermcare-Vet Pty LtdApplicant ACN:010 280 010Summary of use:For the symptomatic treatment of canine atopic dermatitis, contact allergy and other pruritic conditions of the dogDate of Registration:15 April 2020Product registration no.:82108Label approval no.:82108/105030Application no.:105036Product name:Dermcare Barazone 0.125 g/L Budesonide Leave-On ConditionerActive constituent/s:0.125 g/L budesonideApplicant name:Dermcare-Vet Pty LtdApplicant ACN:010 280 010Summary of use:For the symptomatic treatment of canine atopic dermatitis, contact allergy and other pruritic conditions of the dogDate of registration:15 April 2020Product registration no.:82113Label approval no.:82113/105036Application no.:116464Product name:Arthramid VetActive constituent/s:25 mg/mL cross-linked polyacrylamide hydrogelApplicant name:IMS Vet Pty LtdApplicant ACN:620 774 094Summary of use:For the treatment of lameness in horsesDate of registration:15 April 2020Product registration no.:86728Label approval no.:86728/116464Veterinary Products Based on Existing Active ConstituentsApplication no.:119891Product name:Procpen 300 Suspension For InjectionActive constituent/s:300 mg/mL procaine penicillinApplicant name:Abbey Laboratories Pty LtdApplicant ACN:156 000 430Summary of use:For the registration of an antibiotic injection product for use in cattle, sheep, pigs, horses, dogs, and catsDate of registration:21 April 2020Product registration no.:87953Label approval no.:87953/119891Application no.:119596Product name:Bravecto 1 Month 560 Mg Fluralaner Chewable Tablets For Very Large DogsActive constituent/s:54.6 g/kg fluralanerApplicant name:Intervet Australia Pty LimitedApplicant ACN:008 467 034Summary of use:For the treatment and prevention of fleas and ticks in very large dogsDate of registration:22 April 2020Product registration no.:87859Label approval no.:87859/119596Application no.:119597Product name:Bravecto 1 Month 400 Mg Fluralaner Chewable Tablets For Large DogsActive constituent/s:54.6 g/kg fluralanerApplicant name:Intervet Australia Pty LimitedApplicant ACN:008 467 034Summary of use:For the treatment and prevention of fleas and ticks in large dogsDate of registration:22 April 2020Product registration no.:87860Label approval no.:87860/119597Application no.:119598Product name:Bravecto 1 Month 200 Mg Fluralaner Chewable Tablets For Medium DogsActive constituent/s:54.6 g/kg fluralanerApplicant name:Intervet Australia Pty LimitedApplicant ACN:008 467 034Summary of use:For the treatment and prevention of fleas and ticks in medium dogsDate of registration:22 April 2020Product registration no.:87861Label approval no.:87861/119598Application no.:119599Product name:Bravecto 1 Month 100 Mg Fluralaner Chewable Tablets For Small DogsActive constituent/s:54.6 g/kg fluralanerApplicant name:Intervet Australia Pty LimitedApplicant ACN:008 467 034Summary of use:For the treatment and prevention of fleas and ticks in small dogsDate of registration:22 April 2020Product registration no.:87862Label approval no.:87862/119599Application no.:119600Product name:Bravecto 1 Month 45 Mg Fluralaner Chewable Tablets For Very Small DogsActive constituent/s:54.6 g/kg fluralanerApplicant name:Intervet Australia Pty LtdApplicant ACN:008 467 034Summary of use:For the treatment and prevention of fleas and ticks in very small dogsDate of registration:22 April 2020Product registration no.:87863Label approval no.:87863/119600Application no.:124042Product name:Dyfly Spray-on Sheep Blowfly TreatmentActive constituent/s:50 g/L dicyclanilApplicant name:Four Seasons Agribusiness Pty LtdApplicant ACN:115 133 189Summary of use:For the protection of sheep, either off-shears or with any length wool, against fly strike (caused by dicyclanil-susceptible strains of blowflies (Lucilia cuprina) for 18 to 24 weeks. For the protection of mulesing and marking wounds on sheep against fly strike (caused by dicyclanil-susceptible strains of blowflies (Lucilia cuprina)) during the wound healing processDate of registration:23 April 2020Product registration no.:89225Label approval no.:89225/124042Variations of registration Application no.:124747Product name:Abatech Ultra Pour-On Roundworm, Liver Fluke & External Parasiticide For CattleActive constituent/s:300 mg/mL triclabendazole, 5 mg/mL abamectinApplicant name:The Hunter River Company Pty LimitedApplicant ACN:133 798 615Summary of variation:To vary the distinguishing product name and the name that appears on the label from ‘Independents Own Abastar Ultra Pour-On Roundworm, Liver Fluke & External Parasiticide for Cattle’ to ‘Abatech Ultra Pour-On Roundworm, Liver Fluke & External Parasiticide for Cattle’, to vary the safety directions and first aid instructions appearing on a label to reflect the current FAISD handbookDate of variation:3 April 2020Product registration no.:87742Label approval no.:87742/124747Application no.:124769Product name:Jurox Apomorphine Emetic TabletsActive constituent/s:6.5 mg/Tb apomorphine hydrochlorideApplicant name:Jurox Pty LimitedApplicant ACN:000 932 230Summary of variation:To vary the distinguishing product name and the name that appears on the label from ‘Apomorphine Emetic Tablets’ to Jurox Apomorphine Emetic Tablets’Date of variation:6 April 2020Product registration no.:48380Label approval no.:48380/124769Application no.:124917Product name:Ovugel (Triptorelin Acetate) Gel For Intravaginal Use In SowsActive constituent/s:100 mcg/ml triptorelin (as triptorelin acetate)Applicant name:Vetoquinol Australia Pty LtdApplicant ACN:006 949 480Summary of variation:To vary the distinguishing product name and the name that appears on the label from ‘Elanco Ovugel (Triptorelin Acetate) Gel for Intravaginal use in Sows’ to ‘Ovugel (Triptorelin Acetate) Gel for Intravaginal Use in Sows’Date of variation:14 April 2020Product registration no.:69700Label approval no.:69700/124917variation of label approvalApplication no.:123792Product name:All-Trace Trace Element Boluses For CattleActive constituent/s:16509 mg/107g bolus copper (as copper oxide), 249 mg/107g bolus selenium (as sodium selenite), 240 mg/107g bolus cobalt (as cobalt carbonate)Applicant name:Agrimin LtdApplicant ACN:N/ASummary of variation:Variation of label to update to current Vet Labelling CodeDate of variation:15 April 2020Label approval no.:46326Application no.:123978Product name:Oralbute Oral Paste Anti-inflammatory Analgesic For HorsesActive constituent/s:200 mg/mL phenylbutazoneApplicant name:Equivet Pty LimitedApplicant ACN:003 837 492Summary of variation:To update the withholding period statement and to add a restraint statementDate of variation:17 April 2020Label approval no.:42362Application no.:121538Product name:Valabarb Euthanasia SolutionActive constituent/s:300 mg/mL pentobarbitone sodium (equivalent to 273 mg/mL pentobarbitone)Applicant name:Jurox Pty LimitedApplicant ACN:000 932 230Summary of variation:To increase the dose rate from 1–2 ml per 5kg (60–120 mg/kg pentobarbitone sodium) to 1 ml per 2 kg (150 mg/kg pentobarbitone sodium)Date of variation:20 April 2020Label approval no.:36208Application no.:123863Product name:Starmec Pour-on For Beef And Dairy CattleActive constituent/s:5 g/L ivermectinApplicant name:The Hunter River Company Pty LimitedApplicant ACN:133 798 615Summary of variation:To add an additional 500 mL pack sizeDate of variation:24 April 2020Label approval no.:70317Application no.:124242Product name:Zeromec Antiparasitic Injection For CattleActive constituent/s:10 mg/mL ivermectinApplicant name:Abbey Laboratories Pty LtdApplicant ACN:156 000 430Summary of variation:Variation of the product label approval to update the general direction section removing efficacy claims for adult liver flukeDate of variation:27 April 2020Label approval no.:86233Approved 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.:105032Active constituent/s:BudesonideApplicant name:Dermcare-Vet Pty LtdApplicant ACN:010 280 010Summary of use: For use in veterinary chemical productsDate of approval:14 April 2020Approval no.:82110Application no.:116463Active constituent/s:Cross-linked polyacrylamide hydrogelApplicant name:IMS Vet Pty LtdApplicant ACN:620 774 094Summary of use: For use in veterinary chemical productsDate of approval:15 April 2020Approval no.:86727Application no.:121860Active constituent/s:Metalaxyl-MApplicant name:Turf Culture Pty LtdApplicant ACN:117 986 615Summary of use: For use in agricultural chemical productsDate of approval:21 April 2020Approval no.:88629Application no.:121862Active constituent/s:OxadiazonApplicant name:Turf Culture Pty LtdApplicant ACN:117 986 615Summary of use: For use in agricultural chemical productsDate of approval:21 April 2020Approval no.:88631Application no.:121697Active constituent/s:LevamisoleApplicant name:Virbac (Australia) Pty LtdApplicant ACN:003 268 871Summary of use: For use in veterinary chemical productsDate of approval:23 April 2020Approval no.:88560New agricultural active constituent: metcamifenThe Australian Pesticides and Veterinary Medicines Authority (APVMA) has an application for the approval of a new agricultural active constituent, metcamifen, for use as a herbicide safener applied as a seed treatment in mon name:Metcamifen (ISO)IUPAC name:2-Methoxy-N-{4-[(methylcarbamoyl)amino](benzene-1-sulfonyl)}benzamideChemical abstracts name:2-methoxy-N-[[4-[[(methylamino)carbonyl]amino]phenyl]sulfonyl]benzamideCAS number:129531-12-0Molecular formula:C16H17N3O5SMolecular weight:363.4 gmol-1Structure:Chemical family:Aromatic sulfonamideSummary of the APVMA’s EvaluationThe APVMA has evaluated the chemistry aspects of metcamifen active constituent (identification, stability, physicochemical properties, manufacturing process, specifications, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.Impurities of toxicological significance are not expected to occur in metcamifen as a result of the raw materials and the synthetic route used.The APVMA has considered the toxicological aspects of metcamifen, and concluded that there are no toxicological concerns regarding the approval of this active constituent. An Acceptable Daily Intake (ADI) of 0.3 mg/kg bw/d has been established, along with an Acute Reference Dose (ARfD) of 0.3 mg/kg bw for women of childbearing age. An ARfD was unnecessary for the general population.The Scheduling Delegate made a final decision to include metcamifen in Appendix B, Part 3 (substances not requiring control by scheduling) of the Poisons Standard, with an implementation date of 1 February 2020.The APVMA is satisfied that the proposed use of metcamifen would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use.Making a SubmissionIn accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for approval of metcamifen should be granted. Submissions should relate only to matters that are considered in determining whether the safety criteria set out in section 5A of the Agvet Code have been met. Submissions should state the grounds on which they are based.Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.When making a submission please include a:contact namecompany or group name (if relevant)email or postal addressthe date you made the submission.All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially.Written submissions should be addressed in writing to:Director of Chemistry and ManufactureRisk Assessment CapabilityAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001AustraliaPhone:+61 2 6770 2300Email:enquiries@.auNew chemical product: EPIVIO C Sorghum Seed Safener containing metcamifenThe Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for registration of a new product containing a new active constituent. The product is EPIVIO C Sorghum Seed Safener.Particulars of The ApplicationProposed product name(s):EPIVIO C Sorghum Seed SafenerApplicant company:Syngenta Australia Pty LtdName of active constituent:MetcamifenSignal heading:Unscheduled (Appendix B)Summary of proposed use:For use as a seed treatment to protect it from the phytotoxic effects of S-metolachlor.Pack sizes:500 mL to 100 LWithholding period:Harvest: not required when used as directedGrazing: do not graze or cut for stock food for 6 weeks after plantingSummary of the APVMA’s evaluation of EPIVIO C Sorghum Seed Safener in accordance with THE REQUIREMENTS OF SECTION 14(1)(C) of the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994The APVMA has evaluated the application and in its assessment in relation to whether the safety criteria have been met in accordance with the definition set out in section 5A of the Agvet Code, and proposes to determine that:The APVMA is satisfied that the proposed use of EPIVIO C Sorghum Seed Safener would not be an undue hazard to the safety of people exposed to it during its handling and use.The APVMA is satisfied that the proposed use of EPIVIO C Sorghum Seed Safener will not be an undue hazard to the safety of people using anything containing its residues.The APVMA is satisfied that the proposed use of EPIVIO C Sorghum Seed Safener is not likely to be harmful to human beings if used according to the product label directions.The APVMA is satisfied that the proposed use of EPIVIO C Sorghum Seed Safener is not likely to have an unintended effect that is harmful to animals, plants or the environment when used according to the product label directions.The APVMA has evaluated the application and in its assessment in relation to whether the efficacy criteria have been met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials supporting the efficacy of the product adequately demonstrate that, if used according to the product label directions, the product is effective for its proposed uses.The APVMA has evaluated the application and in its assessment in relation to whether the trade criteria have been met in accordance with the definition set out in section 5C of the Agvet Code, and proposes to determine that:The proposed use of EPIVIO C Sorghum Seed Safener would not adversely affect trade between Australia and places outside Australia.FuRther InformationA Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s public consultation page, or by contacting the APVMA as listed below.Making a SubmissionIn accordance with section 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether EPIVIO C Sorghum Seed Safener should be registered. Submissions should relate only to matters that are required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have been met. Submissions should state the grounds on which they are based.Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and in determining appropriate conditions of registration and product labelling.When making a submission please include:contact namecompany or group name (if relevant)email or postal addressthe date you made the submission.All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially.Written submissions should be addressed in writing to:Case Management and Administration UnitAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001AustraliaPhone:+61 2 6770 2300Email:enquiries@.auChange to conditions for the export of phorateAs required by section 69C(2) of the Agricultural and Veterinary Chemicals (Administration) Act?1992, the Australian Government Department of Agriculture, Water and the Environment gives notice that the conditions that apply to the export of the active constituent phorate, or products containing the active constituent phorate, are changing.The amendment is required to fulfil Australia’s obligations under the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (Rotterdam Convention).The Rotterdam Convention is an international treaty promoting shared responsibilities and cooperative efforts in the international trade of certain hazardous chemicals. It creates legally-binding obligations for implementing the Prior Informed Consent (PIC) procedure. Annex?III of the Rotterdam Convention contains a list of chemicals that are subject to the PIC procedure. The PIC procedure aims to ensure that countries do not export chemicals, for use as pesticides, to other countries that have not provided their consent to receive them. Exporting parties must ensure that exports do not occur when the importing country has indicated that it does not consent to imports of that chemical.In order to meet export notification requirements under the Rotterdam Convention, anyone seeking to export a listed chemical must apply to the Department of Agriculture, Water and the Environment for permission to export the chemical (contact details are at the end of this notice). Anyone exporting listed chemicals to countries that are parties to the convention must:include the Harmonised System Customs Code for the chemical (where assigned) on shipping documentation, which can be found at: pic.int/TheConvention/Chemicals/HarmonizedSystemCodes/tabid/1159/language/en-US/Default.aspxensure adequate labelling of the chemical including information aboutrisks and/or hazards to human health and the environmentcompliance with relevant international standards applicable to labelsprovide to the importer (if the chemical is to be used for occupational purposes) a safety data sheet that follows an internationally recognised format, with the most up to date information available, in one of the official languages of the importing partycomply with any specified conditions stipulated by the importing country and promulgated by the secretariat to the Rotterdam Convention as advised by the authorised officer.The amendment applies the PIC procedure to all phorate concentrations.The amendment will not take effect in less than 30 days from the date of this notice.For further information please contact:Agvet Chemicals Policy SectionDepartment of Agriculture, Water and the Environment Phone: +61 2 6272 5337Email: agvetpolicy@.au ................
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