No. APVMA 10, Tuesday, 19 May 2015 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 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 2 Commonwealth of Australia 2015 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: The Manager, Public Affairs and Communications The Australian Pesticides and Veterinary Medicines Authority PO Box 6182 Kingston ACT 2604 Email: communications@apvma.gov.au 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 grant ed 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 activ ity in quarterly statistical reports. DISTRIBUTION AND SUBSCRIPTION The APVMA Gazette is published in electronic format only and is available from the APVMA website, www.apvma.gov.au/publications/gazette/. If you would like to receive email notification when a new edition is published, please subscribe on the APVMA website. APVMA CONTACTS For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4870 For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice. Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 3 CONTENTS Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and Approved Labels .................................................................................................... 19 Approved Active Constituents ....................................................................................................................................... 25 Recall and relabel: Sanonda (Australia) Pty Ltd ............................................................................................................ 26 Recall and relabel: 4Farmers Australia Pty Ltd ............................................................................................................. 27 Amendments to the APVMA MRL Standard.................................................................................................................. 28 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code ............................................ 29 Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 4 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. 2. RESTRICTED PRODUCT Application no.: 63479 Product name: TERM-seal Ura-Fen Termite Resistant Adhesive Active constituent/s: 2 g/kg bifenthrin Applicant name: Term-Seal (Aust) Pty Limited Applicant ACN: 104 603 983 Summary of use For use as an aid to install plastic sheet termite barriers Date of registration/approval: 23 April 2015 Product registration no.: 70455 Label approval no.: 70455/63479 AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS Application no.: 101049 Product name: Apparent Iprodione 250 Fungicide Active constituent/s: 250 g/L iprodione Applicant name: Apparent Pty. Ltd Applicant ACN: 143 724 136 Summary of use For control of certain fungal diseases in various crops, ornamentals and turf Date of registration/approval: 21 April 2015 Product registration no.: 80527 Label approval no.: 80527/101049 Application no.: 62837 Product name: Pool Clear Green Attack Pool Oxidiser Active constituent/s: 800 g/kg available chlorine (Cl) present as trichlorisocyanuric acid, 3 g/kg copper present as copper sulfate pentahydrate Applicant name: Pool Resources Pty Limited Applicant ACN: 062 201 441 Summary of use For controlling bacteria and algae in swimming pools Date of registration/approval: 21 April 2015 Product registration no.: 70257 Label approval no.: 70257/62837 Application no.: 58597 Product name: Crowbar Pro Selective Herbicide Active constituent/s: 400 g/L metribuzin Applicant name: Amgrow Pty Ltd Applicant ACN: 100 684 786 Summary of use For selective post-emergent weed control in turf Date of registration/approval: 23 April 2015 Product registration no.: 68564 Label approval no.: 68564/58597 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 5 Application no.: 61916 Product name: Pennant Magnum Turf Herbicide Active constituent/s: 960 g/L s-metolachlor Applicant name: Syngenta Australia Pty Ltd Applicant ACN: 002 933 717 Summary of use For the control of weeds in turf Date of registration/approval: 23 April 2015 Product registration no.: 69865 Label approval no.: 69865/61916 Application no.: 61912 Product name: Tigerturf Turfguard Commercial Active constituent/s: 500 g/L benzalkonium chloride Applicant name: Tiger Turf Australia Pty Ltd Applicant ACN: 055 247 722 Summary of use Date of registration/approval: For control of moss, algae, lichen and liverwort in lawns, potted plants, garden beds and on paths, roofs and other surfaces 23 April 2015 Product registration no.: 69862 Label approval no.: 69862/61912 Application no.: 62676 Product name: Fungisul 80 Wettable Sulphur Fungicide Active constituent/s: 800 g/kg sulphur (S) Applicant name: Enartis Pacific Pty Ltd Applicant ACN: 132 786 504 Summary of use For the control of certain fungal diseases and mites in a range of crops Date of registration/approval: 23 April 2015 Product registration no.: 70176 Label approval no.: 70176/62676 Application no.: 60955 Product name: Rotam Allez 350 SC Insecticide Active constituent/s: 350 g/L imidacloprid Applicant name: Rotam Agrochemical Co., Ltd Applicant ACN: N/A Summary of use Date of registration/approval: For foliar treatment for control of various insects of cotton, fruit, vegetables and ornamentals and as a soil applied treatment for a range of insect pests in vegetable crops 23 April 2015 Product registration no.: 69506 Label approval no.: 69506/60955 Application no.: 61761 Product name: Nufarm Tazer Xpert Fungicide Active constituent/s: 80 g/L azoxystrobin, 31.25 g/L epoxiconazole Applicant name: Nufarm Australia Limited Applicant ACN: 004 377 780+ Summary of use For the control of certain diseases in wheat, barley and oats Date of registration/approval: 28 April 2015 Product registration no.: 69803 Label approval no.: 69803/61761 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 6 Application no.: 58315 Product name: Tripicrin Drip Soil Fumigant Active constituent/s: 940 g/kg chloropicrin Applicant name: Trical Australia Pty Ltd Applicant ACN: 600 066 966 Summary of use For the control of certain soil-borne pests and diseases in agricultural soils Date of registration/approval: 28 April 2015 Product registration no.: 68413 Label approval no.: 68413/58315 Application no.: 59727 Product name: Wet & Forget Rapid Application Moss and Mould Remover Active constituent/s: 294 g/L benzalkonium chloride Applicant name: Wet And Forget Ltd Applicant ACN: N/A Summary of use Date of registration/approval: For the control of moss, algae, lichen, and liverwort in lawns, potted plants, garden beds and on paths, roofs and other hard surfaces 29 April 2015 Product registration no.: 69055 Label approval no.: 69055/59727 Application no.: 101241 Product name: Titan Alpha-Cypermethrin 250 SC Insecticide Active constituent/s: 250 g/L alpha-cypermethrin Applicant name: Titan Ag Pty Ltd Applicant ACN: 122 081 574 Summary of use For the control of certain insect pests on various field crops and pastures Date of registration/approval: 29 April 2015 Product registration no.: 80598 Label approval no.: 80598/101241 Application no.: 62504 Product name: suSCon maxi Intel Soil Insecticide Active constituent/s: 50 g/kg imidacloprid Applicant name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of use Date of registration/approval: For protection against greyback, negatoria, consobrina and Bundaberg canegrub for 3 years; and Childers and southern one-year canegrub damage for 4 years in sugarcane using sustained control technology 30 April 2015 Product registration no.: 70098 Label approval no.: 70098/62504 Application no.: 63320 Product name: Blast Spray Adjuvant Active constituent/s: 754 g/L ethyl and methyl esters of canola oil fatty acids Applicant name: Victorian Chemical Company Proprietary Limited Applicant ACN: 004 188 863 Summary of use For assistance in the effectiveness of fungicides in cereals, broadacre crops and bananas Date of registration/approval: 1 May 2015 Product registration no.: 70377 Label approval no.: 70377/63320 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 7 Application no.: 63348 Product name: David Grays Systemic Bug Killa Granular Garden Insecticide Active constituent/s: 70 g/kg imidacloprid Applicant name: David Gray & Co. Pty Limited Applicant ACN: 008 671 127 Summary of use Date of registration/approval: For the control of various insect pests on roses, azaleas and ornamentals in and around the home garden 1 May 2015 Product registration no.: 70392 Label approval no.: 70392/63348 Application no.: 60793 Product name: Rotam Milor 720 WP Fungicide Active constituent/s: 640 g/kg mancozeb, 80 g/kg metalaxyl Applicant name: Rotam Agrochemical Co., Ltd. Applicant ACN: N/A Summary of use For control of downy mildew and certain other foliar diseases in various crops Date of registration/approval: 1 May 2015 Product registration no.: 69437 Label approval no.: 69437/60793 Application no.: 62448 Product name: Movento Energy Insecticide Active constituent/s: 120 g/L imidacloprid, 120 g/L spirotetramat Applicant name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of use For control of banana rust thrips and banana weevil borer in bananas Date of registration/approval: 1 May 2015 Product registration no.: 70076 Label approval no.: 70076/62448 Application no.: 62599 Product name: Farmalinx Bomber 250 SL Herbicide Active constituent/s: 250 g/L imazapyr present as the isopropylamine salt Applicant name: Farmalinx Pty Ltd Applicant ACN: 134 353 245 Summary of use For the control of various annual and perennial weeds in non-crop situations Date of registration/approval: 4 May 2015 Product registration no.: 70141 Label approval no.: 70141/62599 Application no.: 61142 Product name: Aerothor Fast Knockdown Fly And Insect Spray Active constituent/s: 3.82 g/kg tetramethrin 20:80, 1.19 g/kg bioallethrin, 1.50 g/kg d-phenothrin Applicant name: Ensystex Australasia Pty Ltd Applicant ACN: 102 221 965 Summary of use For protection against flying and crawling insects Date of registration/approval: 4 May 2015 Product registration no.: 69569 Label approval no.: 69569/61142 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 Application no.: 61143 Product name: Atlas Fast Knockdown Fly And Insect Spray Active constituent/s: 3.82 g/kg tetramethrin 20:80, 1.19 g/kg bioallethrin, 1.50 g/kg d-phenothrin Applicant name: Aaron Laboratories Proprietary Limited Applicant ACN: 004 856 848 Summary of use For protection against flying and crawling insects Date of registration/approval: 4 May 2015 Product registration no.: 69570 Label approval no.: 69570/61143 Application no.: 61144 Product name: Kills Fast! Select Fast Knockdown Fly And Insect Spray Active constituent/s: 3.82 g/kg tetramethrin 20:80, 1.19 g/kg bioallethrin, 1.50 g/kg d-phenothrin Applicant name: Woolworths Ltd Applicant ACN: 000 014 675 Summary of use For protection against flying and crawling insects Date of registration/approval: 4 May 2015 Product registration no.: 69571 Label approval no.: 69571/61144 Application no.: 61145 Product name: Protect-Us Fast Knockdown Aerosol Insect Spray Active constituent/s: 3.82 g/kg tetramethrin 20:80, 1.19 g/kg bioallethrin, 1.50 g/kg d-phenothrin Applicant name: Ensystex Australasia Pty Ltd Applicant ACN: 102 221 965 Summary of use For protection against flying and crawling insects Date of registration/approval: 4 May 2015 Product registration no.: 69572 Label approval no.: 69572/61145 Application no.: 61146 Product name: IGA Signature Fly And Insect Spray Fast Knockdown Active constituent/s: 3.82 g/kg tetramethrin 20:80, 1.19 g/kg bioallethrin, 1.50 g/kg d-phenothrin Applicant name: IGA Distribution (Vic) Pty Limited Applicant ACN: 006 509 280 Summary of use For protection against flying and crawling insects Date of registration/approval: 4 May 2015 Product registration no.: 69573 Label approval no.: 69573/61146 Application no.: 61147 Product name: Hunters Settling Day Fast Knockdown Fly And Insect Spray Active constituent/s: 3.82 g/kg tetramethrin 20:80, 1.19 g/kg bioallethrin, 1.50 g/kg d-phenothrin Applicant name: Hunters Products (Tas.) Proprietary Limited Applicant ACN: 004 601 263 Summary of use For protection against flying and crawling insects Date of registration/approval: 4 May 2015 Product registration no.: 69574 Label approval no.: 69574/61147 Agricultural Chemical Products and Approved Labels 8 Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 Application no.: 62043 Product name: 4Farmers Flumetsulam 800 WG Herbicide Active constituent/s: 800 g/kg flumetsulam Applicant name: 4 Farmers Australia Pty Ltd Applicant ACN: 160 092 428 Summary of use For the control of certain broadleaf weeds in a range of pasture and broad acre crops Date of registration/approval: 5 May 2015 Product registration no.: 69906 Label approval no.: 69906/62043 Application no.: 63411 Product name: Wellfarm Chlorothalonil 720 SC Fungicide Active constituent/s: 720 g/L chlorothalonil Applicant name: Wellfarm Pty Ltd Applicant ACN: 158 518 551 Summary of use Date of registration/approval: For the control of fungal diseases on almonds, bananas, cucurbits, grapes, ornamentals, peanuts, stone fruit, tobacco and vegetables 5 May 2015 Product registration no.: 70415 Label approval no.: 70415/63411 Application no.: 101433 Product name: Garden King Buffalo Weeder Hose On Active constituent/s: 12 g/L bromoxynil present as octanoate ester, 12 g/L MCPA present as the 2-ethylhexyl ester Applicant name: Amgrow Pty Ltd Applicant ACN: 100 684 786 Summary of use For the control of bindii & other weeds in buffalo & other lawns Date of registration/approval: 6 May 2015 Product registration no.: 80691 Label approval no.: 80691/101433 Application no.: 100726 Product name: Generation Blue Rodenticide Block Active constituent/s: 0.025 g/kg difethialone Applicant name: Liphatech S.A.S Applicant ACN: N/A Summary of use Date of registration/approval: For the control of rats and mice in and around agricultural, domestic, commercial, public services and industrial buildings 7 May 2015 Product registration no.: 80381 Label approval no.: 80381/100726 Application no.: 100735 Product name: Generation Green Rodenticide Block Active constituent/s: 0.05 g/kg bromadiolone Applicant name: Liphatech S.A.S Applicant ACN: N/A Summary of use Date of registration/approval: For the control of rats and mice in and around agricultural, domestic, commercial, public services and industrial buildings 7 May 2015 Product registration no.: 80388 Label approval no.: 80388/100735 Agricultural Chemical Products and Approved Labels 9 Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 10 Application no.: 62115 Product name: Gro-Wet Low Volume Application Spreader Active constituent/s: 300 g/L trisiloxane ethoxylate Applicant name: Agrinova New Zealand Limited T/A Gro-Chem Applicant ACN: N/A Summary of use For use with apple thinning plant growth regulator Thin-It Blossom Thinner Date of registration/approval: 7 May 2015 Product registration no.: 69943 Label approval no.: 69943/62115 Application no.: 62962 Product name: Cheminova Paraquat 350 SL Herbicide Active constituent/s: 350 g/L paraquat present as paraquat dichloride Applicant name: 110 199 169 Applicant ACN: Cheminova Australia Pty Limited Summary of use For the control of wide range of grass and broadleaf weeds Date of registration/approval: 8 May 2015 Product registration no.: 70305 Label approval no.: 70305/62962 Application no.: 100673 Product name: agVantage Propiconazole 250 EC Systemic Fungicide Active constituent/s: 250 g/L propiconazole Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use Date of registration/approval: For the control of certain fungal diseases of bananas, oats, peanuts, perennial ryegrass, pineapples, stone fruit, sugarcane, wheat and other crops in certain states 8 May 2015 Product registration no.: 80353 Label approval no.: 80353/100673 Application no.: 100723 Product name: Generation Green Rodenticide Pellet Active constituent/s: 0.05 g/kg bromadiolone Applicant name: Liphatech S.A.S Applicant ACN: N/A Summary of use Date of registration/approval: For the control of rats and mice in and around agricultural, domestic, commercial, public services and industrial buildings 8 May 2015 Product registration no.: 80379 Label approval no.: 80379/100723 Application no.: 100731 Product name: Generation Blue Rodenticide Soft Bait Active constituent/s: 0.025 g/kg difethialone Applicant name: Liphatech S.A.S Applicant ACN: N/A Summary of use Date of registration/approval: For the control of rats and mice including those resistant to other anticoagulants for use in and around buildings and in sewers 8 May 2015 Product registration no.: 80386 Label approval no.: 80386/100731 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 11 Application no.: 100727 Product name: Generation Blue Rodenticide Pellet Active constituent/s: 0.025 g/kg difethialone Applicant name: Liphatech S.A.S Applicant ACN: N/A Summary of use Date of registration/approval: For the control of rats and mice in and around agricultural, domestic, commercial, public services and industrial buildings 8 May 2015 Product registration no.: 80382 Label approval no.: 80382/100727 Application no.: 101494 Product name: Weed Force Evict 360 Herbicide Active constituent/s: 360 g/L glyphosate (present as the isopropylamine salt) Applicant name: Weed Force Pty Ltd Applicant ACN: 602 207 152 Summary of use For non-selective control of many annual and perennial weeds in certain situations Date of registration/approval: 11 May 2015 Product registration no.: 80724 Label approval no.: 80724/101494 Application no.: 101434 Product name: Garden King Extra Strength Feeder Weeder Hose On Active constituent/s: 23 g/L MCPA present as the dimethylamine salt, 3.5 g/L dicamba present as the dimethylamine salt Applicant name: Amgrow Pty Ltd Applicant ACN: 100 684 786 Summary of use For use as a lawn feed and selectively kill broadleaf weeds Date of registration/approval: 11 May 2015 Product registration no.: 80692 Label approval no.: 80692/101434 Application no.: 101507 Product name: Weed Force Gusto Herbicide Active constituent/s: 750 g/kg sulfometuron methyl Applicant name: Weed Force Pty Ltd Applicant ACN: 602 207 152 Summary of use Date of registration/approval: For the control of certain annual and perennial grasses and broadleaf weeds in commercial and industrial areas; around agricultural buildings and rights of way and forestry 12 May 2015 Product registration no.: 80733 Label approval no.: 80733/101507 Application no.: 62679 Product name: Pool Algaecide Banish Active constituent/s: 40 g/L copper (Cu) present as copper sulphate pentahydrate Applicant name: Biolab Australia Pty Ltd Applicant ACN: 005 878 017 Summary of use For use in swimming pools to control algae Date of registration/approval: 12 May 2015 Product registration no.: 70178 Label approval no.: 70178/62679 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 12 Application no.: 101615 Product name: AC Flout 250 SC Fungicide Active constituent/s: 250 g/L flutriafol Applicant name: Axichem Pty Ltd Applicant ACN: 131 628 594 Summary of use Date of registration/approval: For the control of certain fungal diseases in wheat, barley and canola when mixed with fertiliser or applied as a foliar spray 12 May 2015 Product registration no.: 80777 Label approval no.: 80777/101615 Application no.: 101617 Product name: AC Euchre 720 Growth Regulator Active constituent/s: 720 g/L ethephon (an anticholinesterase compound) Applicant name: Axichem Pty Ltd Applicant ACN: 131 628 594 Summary of use Date of registration/approval: For crop thinning, loosening or ripening in various crops and for accelerating boll opening, defoliation and pre-conditioning before defoliation of cotton 12 May 2015 Product registration no.: 80779 Label approval no.: 80779/101617 Application no.: 62168 Product name: StarrDust Pro Insecticidal Dusting Powder Industrial Strength Active constituent/s: 20 g/kg permethrin 40:60, 5 g/kg triflumuron Applicant name: Sundew Solutions Pty Ltd Applicant ACN: 135 400 261 Summary of use For control of various insect pests in domestic and industrial situations Date of registration/approval: 12 May 2015 Product registration no.: 69956 Label approval no.: 69956/62168 Application no.: 61829 Product name: Vibrance Extreme Seed Treatment Active constituent/s: 36.9 g/L difenoconazole, 30.7 g/L thiamethoxam, 9.5 g/L metalaxyl-m, 8 g/L sedaxane Applicant name: Syngenta Australia Pty Ltd Applicant ACN: 002 933 717 Summary of use Date of registration/approval: For seed treatment of barley, oats, triticale and wheat to provide control or suppression of seed and soil borne diseases, and to provide long lasting control of progeny and control or suppression of adults of major grain storage pests 13 May 2015 Product registration no.: 69822 Label approval no.: 69822/61829 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 3. Agricultural and Veterinary Chemicals Code Act 1994 13 VARIATIONS OF REGISTRATION Application no: 102230 Product name: Active constituent/s: Apparent Weedfree Glyphosate Granular Herbicide 700 g/kg glyphosate present as the mono-ammonium salt Applicant name: Apparent Pty. Ltd Applicant ACN: Date of variation: 143 724 136 To change the product name from ‘WEEDFREE GLYPHOSATE GRANULES HERBICIDE’ to ‘APPARENT WEEDFREE GLYPHOSATE GRANULES HERBICIDE’ 8 April 2015 Product registration no.: 68394 Label approval no.: 68394/102230 Application no: 102235 Product name: Apparent Poacher 750 Herbicide Active constituent/s: 750 g/kg imazapyr 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 IMAZAPYR 750 SG HERBICIDE’ to ‘APPARENT POACHER 750 HERBICIDE’ Date of variation: 9 April 2015 Product registration no.: 69538 Label approval no.: 69538/102235 Application no: 102233 Product name: Apparent Rocky 745 Herbicide Active constituent/s: 745 g/L flupropanate present as the sodium salt Applicant name: Apparent Pty. Ltd Applicant ACN: Date of variation: 143 724 136 To change the product name from ‘APPARENT FLUPROPANATE 745 HERBICIDE’ to ‘APPARENT ROCKY 745 HERBICIDE’ 9 April 2015 Product registration no.: 67076 Label approval no.: 67076/102233 Application no: 102232 Product name: Apparent Pilferer 500 Herbicide Active constituent/s: 500 g/L propyzamide Applicant name: Apparent Pty. Ltd. Applicant ACN: Date of variation: 143 724 136 To change the product name from ‘APPARENT PROPYZAMIDE 500 SC HERBICIDE’ to ‘APPARENT PILFERER 500 HERBICIDE’ 9 April 2015 Product registration no.: 68267 Label approval no.: 68267/102232 Summary of variation: Summary of variation: Summary of variation: Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 14 Application no: 102296 Product name: Apparent Cross-Cut Saw 750 SG Herbicide Active constituent/s: 750 g/kg hexazinone Applicant name: Apparent Pty Ltd Applicant ACN: Date of variation: 143 724 136 To change the distinguishing product name and the name that appears on the label from ‘APPARENT HEXAZINONE 750 SG HERBICIDE’ to ‘APPARENT CROSS-CUT SAW 750 SG HERBICIDE’ 16 April 2015 Product registration no.: 70220 Label approval no.: 70220/102296 Application no: 101175 Product name: AC Dozer 400 Herbicide Active constituent/s: 400 g/L fluroxypyr as the methyl heptyl ester Applicant name: Axichem Pty Ltd Applicant ACN: 131 628 594 Summary of variation: To change the product name from ‘AC TRAMPLE 400 HERBICIDE’ to ‘AC DOZER 400 HERBICIDE’ Date of variation: 21 April 2015 Product registration no.: 69268 Label approval no.: 69268/101175 Application no: 102334 Product name: Blockaid-Aqua Termiticide Sealant Active constituent/s: 2 g/kg bifenthrin Applicant name: Granitgard Marketing Pty Ltd Applicant ACN: 003 630 153 Summary of variation: To change the product name from ‘AQUABLOCKAID TERMITICIDE SEALANT’ to ‘BLOCKAID-AQUA TERMITICIDE SEALANT’ Date of variation: 21 April 2015 Product registration no.: 69789 Application no.: 102336 Product name: Blockaid-Termi Termiticide Sealant Active constituent/s: 2 g/kg bifenthrin Applicant name: Granitgard Marketing Pty Ltd Applicant ACN: Date of registration/approval: 003 630 153 To change the product name from ‘TERMIBLOCKAID TERMITICIDE SEALANT’ to ‘BLOCKAIDTERMI TERMITICIDE SEALANT’ 21 April 2015 Product registration no.: 67161 Application no: 100600 Mint-X Rodent and Cockroach Repellent Garbage Bags Summary of variation: Summary of use Product name: Active constituent/s: 2.88 g/kg methyl salicylate, 2.88 g/kg corn mint oil, 1.84 g/kg camphor white oil, 0.4 g/kg eucalyptus oil Applicant name: Mint-X Corporation Applicant ACN: Summary of variation: N/A To add use on cockroaches Date of variation: 27 April 2015 Product registration no.: 67230 Label approval no.: 67230/100600 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 15 Application no: 101535 Product name: Sinmosa 250 Herbicide Active constituent/s: 250 g/L paraquat present as paraquat dichloride Applicant name: Sinon Australia Pty Limited Applicant ACN: 102 741 024 Summary of variation: To add additional pack sizes and additional State use pattern Date of variation: 28 April 2015 Product registration no.: 58992 Label approval no.: 58992/101535 Application no: 100892 Product name: Rustler 900 WG Herbicide Active constituent/s: 900 g/kg propyzamide Applicant name: Cheminova Australia Pty Limited Applicant ACN: 110 199 169 Summary of variation: To extend the use to include canola, oilseed poppies, lettuce and buffalo grass Date of variation: 28 April 2015 Product registration no.: 69519 Label approval no.: 69519/100892 Application no: 101389 Product name: Mortein Naturgard Multi-Insect Automatic Spray Indoor Wild Flower Active constituent/s: 8.0 g/kg permethrin, 6.0 g/kg transfluthrin Applicant name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of variation: To change the product name from ‘MORTEIN NATURGARD AUTO PROTECT INDOOR LAVENDER’ to ‘MORTEIN NATURGARD MULTI-INSECT AUTOMATIC SPRAY INDOOR WILD FLOWER’ Date of variation: 28 April 2015 Product registration no.: 69711 Label approval no.: 69711/101389 Application no: 102196 Product name: Apparent Cachet Glyphosate 450 Herbicide Active constituent/s: 450 g/L glyphosate present as the isopropylamine salt Applicant name: Apparent Pty. Ltd Applicant ACN: 143 724 136 Summary of variation: To change the product name from ‘CACHET GLYPHOSATE 450 HERBICIDE’ to ‘APPARENT CACHET GLYPHOSATE 450 HERBICIDE’ Date of variation: 6 April 2015 Product registration no.: 67005 Label approval no.: 67005/102196 Application no: 58439 Product name: Imtrade Edge 900 WG Herbicide Active constituent/s: 900 g/kg propyzamide Applicant name: Imtrade Australia Pty Ltd Applicant ACN: 090 151 134 Summary of variation: To extend the use to include the control of annual ryegrass in canola Date of variation: 29 April 2015 Product registration no.: 63332 Label approval no.: 63332/58439 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 16 Application no: 101356 Product name: Mortein Outdoor Fly & Mosquito Automatic Spray Citronella Active constituent/s: 8 g/kg permethrin, 6 g/kg transfluthrin Applicant name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of variation: To change the product from ‘MORTEIN NATURGARD AUTO PROTECT OUTDOOR CITRONELLA’ to ‘MORTEIN OUTDOOR FLY & MOSQUITO AUTOMATIC SPRAY CITRONELLA’ and amend claim of use statement Date of variation: 29 April 2015 Product registration no.: 68099 Label approval no.: 68099/101356 Application no: 101358 Product name: Mortein Outdoor Fly & Mosquito Automatic Spray Odourless Active constituent/s: 8 g/kg permethrin, 6 g/kg transfluthrin Applicant name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of variation: To change the product from ‘MORTEIN NATURGARD AUTO PROTECT OUTDOOR ODOURLESS’ to ‘MORTEIN OUTDOOR FLY & MOSQUITO AUTOMATIC SPRAY ODOURLESS’ and amend claim of use statement Date of variation: 29 April 2015 Product registration no.: 68097 Label approval no.: 68097/101358 Application no: 100865 Product name: Veteran Plus Seed Treatment Active constituent/s: 180 g/L imidacloprid, 6.25 g/L flutriafol Applicant name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of variation: To include a claim for protection against insect pests of stored seed grain Date of variation: 1 May 2015 Product registration no.: 63978 Label approval no.: 63978/100865 Application no: 101415 Product name: Mortein Fast Knockdown Crawling Insect Killer Active constituent/s: 2.0 g/kg cypermethrin, 0.7 g/kg imiprothrin Applicant name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of variation: To change the product name from ‘MORTEIN CRAWLING INSECT KILLER RAPID KILL’ to ‘MORTEIN FAST KNOCKDOWN CRAWLING INSECT KILLER’ Date of variation: 6 May 2015 Product registration no.: 69717 Label approval no.: 69717/101415 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 17 Application no: 101462 Product name: Active constituent/s: Mortein Naturgard Crawling Insect Surface Spray Eucalyptus 0.6 g/kg deltamethrin, 0.4 g/kg imiprothrin Applicant name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of variation: To change the product name from ‘MORTEIN NATURGARD CRAWLING INSECT SURFACE SPRAY CONTAINS NATURAL EUCALYPTUS EXTRACTS OVER 90% NATURAL INGREDIENTS’ to ‘MORTEIN NATURGARD CRAWLING INSECT SURFACE SPRAY EUCALYPTUS’ Date of variation: 6 May 2015 Product registration no.: 66787 Label approval no.: 66787/101462 Application no: 101463 Product name: Active constituent/s: Mortein Naturgard Crawling Insect Surface Spray Odourless 0.6 g/kg deltamethrin, 0.4 g/kg imiprothrin Applicant name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of variation: To change the product name from ‘MORTEIN NATURGARD CRAWLING INSECT SURFACE SPRAY ODOURLESS OVER 90% NATURAL INGREDIENTS’ to ‘MORTEIN NATURGARD CRAWLING INSECT SURFACE SPRAY ODOURLESS’ Date of variation: 6 May 2015 Product registration no.: 69381 Label approval no.: 69381/101463 Application no: 101456 Product name: Mortein Naturgard Crawling Insect Control Bomb Household Protection Active constituent/s: 10 g/Kg Permethrin Applicant name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of variation: To change the product name from ‘MORTEIN NATURGARD CONTROL BOMB HOUSEHOLD PROTECTION’ to ‘MORTEIN NATURGARD CRAWLING INSECT CONTROL BOMB HOUSEHOLD PROTECTION’ and update claim of use statement Date of variation: 6 May 2015 Product registration no.: 66283 Label approval no.: 66283/101456 Application no: 101732 Product name: Magister Herbicide Active constituent/s: 480 g/L clomazone Applicant name: FMC Australasia Pty Ltd Applicant ACN: 095 326 891 Summary of variation: To delete the requirement for mixing Magister Herbicide with a drift retardant as listed on the Directions For Use-(critical comments) for Dry Broadcast and Aerial Sown Rice-Flooded BaySingle Applications Date of variation: 7 May 2015 Product registration no.: 52202 Label approval no.: 52202/101732 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 18 Application no: 62490 Product name: Tackle WG Herbicide Active constituent/s: 750 g/kg chlorsulfuron Applicant name: Adama Australia Pty Limited Applicant ACN: 050 328 973 Summary of variation: To change the product name from ‘FARMOZ TACKLE WG HERBICIDE’ to ‘TACKLE WG HERBICIDE’ and to specify a different trifluralin product for use in tankmix for wheat and triticale Date of variation: 8 May 2015 Product registration no.: 59842 Label approval no.: 59842/62490 Application no: 101418 Product name: Mortein Fast Knockdown Multi Insect Killer Trusted Household Protection Active constituent/s: 1 g/kg esbiothrin, 0.3 g/kg permethrin, 0.2 g/kg imiprothrin Applicant name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of variation: To change the product name from ‘MORTEIN MULTI INSECT KILLER FAST KNOCKDOWN’ to ‘MORTEIN FAST KNOCKDOWN MULTI INSECT KILLER TRUSTED HOUSEHOLD PROTECTION’ and add 250 g, 320 g, 340 g, 350 g and 370 g pack sizes Date of variation: 11 May 2015 Product registration no.: 69354 Label approval no.: 69354/101418 Agricultural Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 19 Veterinary Chemical Products and Approved Labels Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown. 1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS Application no.: 62248 Product name: Neove Apramycin Soluble Powder Active constituent/s: 550 mg/g apramycin (as apramycin sulfate) Applicant name: Neove Pharma Australia Pty Limited Applicant ACN: 140 367 442 Summary of use For the control and treatment of colisepticaemia (colibacillosis) caused by susceptible strains of E.coli in broilers Date of registration/approval: 24 April 2015 Product registration no.: 69993 Label approval no.: 69993/62248 Application no.: 56942 Product name: Gonasyn Active constituent/s: 50 ug/mL gonadorelin acetate Applicant name: Syntex S.A. Applicant ACN: N/A Summary of use For use in oestrus synchronisation programs in combination with PGF2a, and for the treatment of cystic ovaries, prevention of delayed ovulation and improvement of postpartum fertility in cattle Date of registration/approval: 28 April 2015 Product registration no.: 67837 Label approval no.: 67837/56942 Application no.: 60212 Product name: NeoK9Cell Active constituent/s: 0.5–0.8 L/L canine erythrocytes Applicant name: Australian Animal Blood Bank Pty Ltd Applicant ACN: 140 128 990 Summary of use For aid in the treatment of clinically significant anaemia, acute blood loss (traumatic or surgical haemorrhage) or a symptomatic deficit of oxygen carrying capacity Date of registration/approval: 29 April 2015 Product registration no.: 69197 Label approval no.: 69197/60212 Veterinary Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 20 Application no.: 62405 Product name: Q-Drench Mineralised Multi-Combination Drench For Sheep Active constituent/s: 40 g/L levamisole hydrochloride, 37.5 g/L closantel, 25 g/L albendazole, 1 g/L abamectin, 2.1 g/L copper (as disodium copper ehtylenediamine tetraacetate), 1 g/L iodine (as ethylenediamine dihydroiodide), 0.6 g/L zinc (as disodium zinc ethylenediamine tetraacetate), 0.5 g/L selenium (as sodium selenate), 0.2 g/L cobalt (as disodium cobalt ethylenediamine tetraacetate) Applicant name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of use For the treatment and control of sensitive gastrointestinal roundworms and lungworm, tapeworms, mature and late immature liver fluke, nasal bots and itchmites and as an aid in the control of copper, cobalt, selenium, iodine and zinc deficiencies in sheep Date of registration/approval: 30 April 2015 Product registration no.: 70059 Label approval no.: 70059/62405 Application no.: 100920 Product name: Moximax Moxidectin Plus Selenium Oral Drench For Sheep Active constituent/s: 1 mg/ml moxidectin, 0.5 mg/ml selenium (as sodium selenate) Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use For use in the treatment and control of moxidectin-sensitive gastrointestinal parasites, lungworm and itchmite in sheep, and as an aid in the control of selenium responsive conditions Date of registration/approval: 30 April 2015 Product registration no.: 80469 Label approval no.: 80469/100920 Application no.: 101141 Product name: Topdek Long Acting Injection For Sheep Active constituent/s: 20 g/L moxidectin Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use For use in the treatment and control of roundworms, nasal bot and itchmite in sheep Date of registration/approval: 1 May 2015 Product registration no.: 80571 Label approval no.: 80571/101141 Application no.: 101142 Product name: Moximax Moxidectin Long Acting Injection For Sheep Active constituent/s: 20 g/L moxidectin Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use For use in the treatment and control of roundworms, nasal bot and itchmite in sheep Date of registration/approval: 1 May 2015 Product registration no.: 80572 Label approval no.: 80572/101142 Veterinary Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 21 Application no.: 101143 Product name: Topdek Plus Selenium Oral Drench For Sheep Active constituent/s: 1 mg/mL moxidectin, 0.5 mg/mL selenium (as sodium selenate) Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use For use in the treatment and control of moxidectin-sensitive gastrointestinal parasites, lungworm and itchmite in sheep, and as an aid in the control of selenium responsive conditions Date of registration/approval: 1 May 2015 Product registration no.: 80573 Label approval no.: 80573/101143 Application no.: 62371 Product name: Protech Bronchi-Shield Oral Bordetella Bronchiseptica Live Vaccine Active constituent/s: each dose contains live avirulent bordetella bronchiseptica (≥1 x 108 CFU per dose) Applicant name: Boehringer Ingelheim Pty Limited, Vetmedica Division Applicant ACN: 000 452 308 Summary of use For the active immunisation of healthy dogs and puppies over 8 weeks of age as an aid in the prevention of disease caused by bordetella bronchiseptica Date of registration/approval: 4 May 2015 Product registration no.: 70050 Label approval no.: 70050/62371 Application no.: 58535 Product name: Novormon eCG Active constituent/s: 200 IU/mL serum gonadotrophin when reconstituted Applicant name: Syntex S.A. Applicant ACN: N/A Summary of use For hormonal manipulation of reproduction in cattle, goats, sheep and dogs Date of registration/approval: 4 May 2015 Product registration no.: 68533 Label approval no.: 68533/58535 Application no.: 101481 Product name: Cattlepro Pour-On For Beef And Dairy Cattle Active constituent/s: 5 g/L ivermectin Applicant name: Specialist Sales Pty Ltd Applicant ACN: 103 415 603 Summary of use For use in the treatment and control of internal and external parasites of beef and dairy cattle Date of registration/approval: 7 May 2015 Product registration no.: 80714 Label approval no.: 80714/101481 Application no.: 62672 Product name: Elanco Temephos 350 Sheep Dip Active constituent/s: 350 g/L temephos (an anticholinesterase compound) Applicant name: ELANCO ANIMAL HEALTH A DIV OF ELI LILLY AUST PTY LTD Applicant ACN: 000 233 992 Summary of use For use in the control of body lice on wet and dry short wool sheep by plunge or shower dipping Date of registration/approval: 7 May 2015 Product registration no.: 70173 Label approval no.: 70173/62672 Veterinary Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 2. Agricultural and Veterinary Chemicals Code Act 1994 22 Application no.: 100855 Product name: Vets Choice For Puppies Worming Suspension Active constituent/s: 15 mg febantel, 14.4 mg pyrantel embonate equivalent to 5 mg pyrantel base Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of use For the control of roundworms, hookworms and whipworms in puppies and small dogs Date of registration/approval: 7 May 2015 Product registration no.: 80433 Label approval no.: 80433/100855 Application no.: 51110 Product name: Bob Martin Since 1892 Flea & Tick Rid for Dogs, Cats, Puppies, Kittens, Rodents & Caged Birds Pyrethrins Rinse Active constituent/s: 10 g/L pyrethrins, 18 g/L piperonyl butoxide, 30 g/L n-octyl bicycloheptene dicarboximide Applicant name: Bob Martin (Australia) Pty Ltd Applicant ACN: 062 627 883 Summary of use For the control of fleas, lice and ticks on dogs and cats and lice on ornamental caged birds and rodents Date of registration/approval: 13 May 2015 Product registration no.: 65522 Label approval no.: 65522/51110 Application no.: 61900 Product name: Glyde Mobility Chews For Dogs Active constituent/s: Each chew contains 285 mg chondroitin sulfate sodium (bovine origin), 570 mg glucosamine hydrochloride, 760 mg green lipped mussel powder Applicant name: Parnell Technologies Pty Ltd Applicant ACN: 138 251 635 Summary of use For improvement of joint health and function in dogs Date of registration/approval: 13 May 2015 Product registration no.: 69858 Label approval no.: 69858/61900 VARIATIONS OF REGISTRATION Application no.: Product name: 102091 Cobalex 2000 B12 Plus Selenium Injection Active constituent/s: 4 mg/mL selenium (as sodium selenate), 2 mg/mL hydroxocobalamin (as the acetate) Applicant name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of variation: To change the product name from ‘COBALEX 2000 PLUS SELENIUM INJECTION’ to ‘COBALEX 2000 B12 PLUS SELENIUM INJECTION’ Date of variation: 26 March 2015 Product registration no.: 64781 Label approval no.: 64781/102091 Veterinary Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Application no: Agricultural and Veterinary Chemicals Code Act 1994 23 Product name: 102086 Cobalex 2000 B12 Injection Active constituent/s: 2 mg/mL hydroxocobalamin (as the acetate) Applicant name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of variation: To change the product name from ‘COBALEX 2000 INJECTION’ to ‘COBALEX 2000 B12 INJECTION’ Date of variation: 26 March 2015 Product registration no.: 67608 Label approval no.: 67608/102086 Application no.: 102231 Product name: Exelpet Vet Series Total Tick Collar For Dogs Active constituent/s: Applicant name: 90 g/kg amitraz Exelpet Products A Div Of Mars Australia Pty Ltd Applicant ACN: 008 454 313 Summary of variation: To change the product name from ‘EXELPET VET SERIES TOTAL TICK COLLAR’ to ‘EXELPET VET SERIES TOTAL TICK COLLAR FOR DOGS’ Date of variation: 8 April 2015 Product registration no.: 70133 Label approval no.: 70133/102231 Application no.: 102277 Product name: Strategy-T Oral Broad Spectrum Worm Paste For Horses Active constituent/s: 7.0 g oxfendazole, 9.1 g pyrantel embonate Applicant name: Virbac (Australia) Pty Ltd Applicant ACN: Date of variation: 003 268 871 To change the product name from ‘STRATEGY-T PASTE ORAL BROAD SPECTRUM WORM PASTE FOR HORSES’ to ‘STRATEGY-T ORAL BROAD SPECTRUM WORM PASTE FOR HORSES’ 14 April 2015 Product registration no.: 61370 Label approval no.: 61370/102277 Application no.: 61112 Product name: Coopers TRIFECTA Triple Active Drench for Sheep and Cattle Mineralised Active constituent/s: 2 g/L abamectin, 80 g/L levamisole hydrochloride, 45.3 g/L oxfendazole, 5 g/L cobalt (as cobalt EDTA), 1 g/L selenium (as sodium selenate) Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of variation: To assign treatment to calving interval to allow use in non-lactating dairy cattle Date of variation: 21 April 2015 Product registration no.: 67327 Label approval no.: 67327/61112 Application no.: 101953 Product name: Abbeymox FG Feed Grade Amoxycillin Soluble Powder Active constituent/s: 870 g/kg amoxicillin as the trihydrate Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of variation: To extend the shelf life of the product Date of variation: 30 April 2015 Product registration no.: 68888 Label approval no.: 68888/101953 Summary of variation: Veterinary Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 3. Agricultural and Veterinary Chemicals Code Act 1994 24 Application no: 101728 Product name: Tylodox 1000 Active constituent/s: 903 g/kg tylosin as tylosin phosphate Applicant name: Dox-Al Australia Pty Ltd Applicant ACN: 079 454 265 Summary of variation: To change the product name from ‘RUMIDOX’ to ‘TYLODOX 1000’ and include additional pack sizes Date of variation: 30 April 2015 Product registration no.: 65360 Label approval no.: 65360/101728 Application no.: 58347 Product name: Elanco AH0635 Apralan Soluble Powder Active constituent/s: not more than 595 mg/g apramycin (as apramycin sulphate), each bag contains 1000 g apramycin (as apramycin sulphate) Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd Applicant ACN: 000 233 992 Summary of variation: To extend shelf life and update registered particulars and label Date of variation: 5 May 2015 Product registration no.: 47742 Label approval no.: 47742/58347 Application no.: 55699/61206 Product name: Genesis Ultra Injection Broad Spectrum Antiparasitic For Cattle Active constituent/s: 10 mg/mL ivermectin, 100 mg/mL clorsulon Applicant name: Merial Australia Pty Ltd Applicant ACN: 071 187 285 Summary of variation: To change the product name from ‘GENESIS ULTRA INJECTION BROAD SPECTRUM ANTIPARASITIC FOR BEEF CATTLE’ to ‘GENESIS ULTRA INJECTION BROAD SPECTRUM ANTIPARASITIC FOR CATTLE’ and extend use to dairy heifers up to the point of first mating Date of variation: 7 May 2015 Product registration no.: 55699 Label approval no.: 55699/61206 VARIATION OF LABEL APPROVAL Application no.: 101686 Product name: Neopharm Antibiotic Feed Additive Active constituent/s: minimum 600 g/kg neomycin (as neomycin sulphate) Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: To update the label particulars Date of variation: 11 May 2015 Label approval no.: 58671/101686 Veterinary Chemical Products and Approved Labels Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 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.: 63128 Active constituent/s: Ethanedinitrile Applicant name: BOC Limited Applicant ACN: 000 029 729 Summary of use: For use in agricultural chemical products Date of approval: 23 April 2015 Approval no.: 70319 Application no.: 100229 Active constituent/s: Imazapyr Applicant name: Shandong Rainbow International Co., Ltd Applicant ACN: N/A Summary of use: For use in agricultural chemical products Date of approval: 24 April 2015 Approval no.: 80109 Application no.: 63450 Active constituent/s: Thiacloprid Applicant name: Sabakem Pty Ltd Applicant ACN: 151 682 138 Summary of use: For use in agricultural chemical products Date of approval: 30 April 2015 Approval no.: 70432 Application no.: 100639 Active constituent/s: Methyl bromide Applicant name: A-Gas (Australia) Pty Limited Applicant ACN: 066 273 247 Summary of use: For use in agricultural chemical products Date of approval: 11 May 2015 Approval no.: 80333 Application no.: 63445 Active constituent/s: Azoxystrobin Applicant name: Sabakem Pty Ltd Applicant ACN: 151 682 138 Summary of use: For use in agricultural chemical products Date of approval: 12 May 2015 Approval no.: 70428 Approved Active Constituents 25 Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 26 Recall and relabel: Sanonda (Australia) Pty Ltd NOTICE UNDER SECTION 103 OF THE AGVET CODE. NO 1 OF 2015 Sanonda Herbicide Diuron 900WG On 1 May 2015 the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to Sanonda (Australia) Pty Ltd pursuant to Section 103 of the Agvet Codes in relation to Sanonda Herbicide Diuron 900WG ( product number 65536). The notice requires Sanonda to stop supply of the product bearing a label not currently approved by the APVMA, to relabel such stocks with a label bearing particulars approved by the APVMA and report to the APVMA. SAFETY To avoid damage to the environment, the product must only be used in accordance with the particulars currently approved by the APVMA. SUPPLIER DETAILS Sanonda (Australia) Pty Ltd Suite 822, St Kilda Road Towers 1 Queens Road MELBOURNE VIC 3004 APVMA CONTACT For further information please contact: Director, Compliance and Monitoring Legal and Compliance Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4796 Fax: +61 2 6210 4813 Email: compliance@apvma.gov.au Recall and relabel: Sanonda (Australia) Pty Ltd Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 27 Recall and relabel: 4Farmers Australia Pty Ltd NOTICE UNDER SECTION 103 OF THE AGVET CODE. NO 2 OF 2015 4Farmers Diuron 900DF Herbicide On 6 May 2015 the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to 4Farmers Australia Pty Ltd pursuant to Section 103 of the Agvet Codes in relation to 4Farmers Diuron 900DF Herbicide (product number 56356). The notice requires 4Farmers to stop supply and relabel stock on hand that does not bear the APVMA approved label, to provide revised instructions to purchasers of stocks held by retailers and distributors, and to record that these instructions have been provided to purchasers, and report to the APVMA. SAFETY To avoid damage to the environment, the product must only be used in accordance with the particulars currently approved by the APVMA. SUPPLIER DETAILS 4Farmers Australia Pty Ltd 35 McDowell Street WELSHPOOL WA 6106 APVMA CONTACT For further information please contact: Director, Compliance and Monitoring Legal and Compliance Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4796 Fax: +61 2 6210 4813 Email: compliance@apvma.gov.au Recall and relabel: 4Farmers Australia Pty Ltd Commonwealth of Australia Gazette No. APVMA 10, Tuesday, 19 May 2015 Agricultural and Veterinary Chemicals Code Act 1994 28 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 2015 (No. 4). 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 4840 Email: enquiries@apvma.gov.au Amendments to the APVMA MRL Standard Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 29 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code In the previous notice, the APVMA gazetted that 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 2015 (No. 4)) to MRLs into Standard 1.4.2. Maximum Residue Limits of the Australia New Zealand Food Standards Code. MRLs contained in Standard 1.4.2 provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this means, Standard 1.4.2 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 Standard 1.4.2 in the APVMA Gazette. The variations will take effect as from the date of that subsequent notice. Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 30 DRAFT VARIATIONS TO THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE Note: The following amendments are in a format that accords with the proposed amending Legislative Instrument which, in turn, has to be consistent with the existing format of Standard 1.4.2 (Maximum Residue Limits) of the Australia New Zealand Food Standards Code. PROPOSED AMENDMENT (AGRICULTURAL AND VETERINARY CHEMICALS CODE INSTRUMENT NO. 4 (MRL STANDARD) AMENDMENT INSTRUMENT 2015 (NO. 4)) 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 Standard 1.4.2 of the Australia New Zealand Food Standards Code is varied by – 1. omitting from Schedule 1 the chemical residue definition for Fluxapyroxad and substituting the following chemical residue definitionFluxapyroxad 2. inserting in alphabetical order in Schedule 1 – Bixafen Commodities of plant origin: Bixafen Commodities of animal origin: Sum of bixafen and N-(3',4'dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1Hpyrazole-4-carboxamide (bixafen-desmethyl), expressed as bixafen Barley T0.3 Eggs T*0.02 Edible offal (mammalian) T1 Meat (mammalian) (in the fat) T0.3 Milks T*0.02 Poultry, edible offal of T*0.02 Poultry meat (in the fat) T*0.02 Pulses T0.1 Rape seed T*0.01 Wheat T0.5 3. inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals – Azoxystrobin Azoxystrobin Anise myrtle leaves (dried) Lemon myrtle leaves (dried) T3 T3 Bifenazate Sum of bifenazate and bifenazate diazene (diazenecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl-3-yl] 1-methylethyl ester), expressed as bifenazate Eggs *0.01 Fruiting vegetables, cucurbits 1 Fruiting vegetables, other than 1 cucurbits [except mushrooms and sweet corn (corn-on-the-cob)] Poultry, edible offal of *0.01 Poultry meat *0.01 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 Cyprodinil Cyprodinil Bulb vegetables [except fennel, bulb; garlic; onion, bulb] Chives 31 T3 T3 Difenoconazole Difenoconazole Anise myrtle (dried) Lemon myrtle leaves (dried) Riberries T10 T10 T1 Fludioxonil Commodities of animal origin: Sum of fludioxonil and oxidisable metabolites, expressed as fludioxonil Commodities of plant origin: Fludioxonil Bulb vegetables [except fennel, bulb; T3 garlic; onion, bulb] Chives T3 Prothioconazole Commodities of plant origin: Sum of prothioconazole and prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole Commodities of animal origin: Sum of prothioconazole, prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxy-desthio (2-(1chlorocyclopropyl)-1-(2-chloro-3-hydroxyphenyl)-3-(1H1,2,4-triazol-1-yl)-propan-2-ol) and prothioconazole-4hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-4hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole Pulses T0.1 Tebuconazole Tebuconazole Anise myrtle leaves (dried) Lemon myrtle leaves (dried) 4. T5 T5 omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals – Azoxystrobin Azoxystrobin Anise myrtle leaves Lemon myrtle leaves T100 T100 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 32 Bifenazate Sum of bifenazate and bifenazate diazene (diazenecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl-3-yl] 1-methylethyl ester), expressed as bifenazate Bitter melon T0.5 Cucumber T0.5 Egg plant T0.1 Melons, except watermelon T0.3 Peppers T0.5 Sinkwa or Sinkwa towel gourd T0.5 Squash, Summer T0.5 Tomato T1 Watermelon T0.3 Prothioconazole Commodities of plant origin: Sum of prothioconazole and prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole Commodities of animal origin: Sum of prothioconazole, prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxy-desthio (2-(1chlorocyclopropyl)-1-(2-chloro-3-hydroxyphenyl)-3-(1H1,2,4-triazol-1-yl)-propan-2-ol) and prothioconazole-4hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-4hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole Chick-pea (dry) T0.7 Lentil (dry) T0.7 5. omitting from Schedule 1, under the entries for the following chemicals, the maximum residue limit for the food, substituting – Azoxystrobin Azoxystrobin Riberries T1 Bifenazate Sum of bifenazate and bifenazate diazene (diazenecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl-3-yl] 1-methylethyl ester), expressed as bifenazate Papaya (pawpaw) 2 Strawberry 2 Fluxapyroxad Commodities of plant origin: Fluxapyroxad Commodities of animal origin for enforcement: Fluxapyroxad Milk fats 0.1 Indoxacarb Sum of indoxacarb and its R-isomer Chia T0.5 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 33 Triadimenol Triadimenol see also Triadimefon Riberries T0.3 INVITATION FOR SUBMISSIONS Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the proposal to vary Standard 1.4.2 Maximum Residue Limits of 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 Standard 1.4.2’ and quote the correct amendment number. DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (AEST) 16 June 2015 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. For further information please contact: MRL Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4897 Fax: +61 2 6210 4840 Email: enquiries@apvma.gov.au Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
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