TABLE OF CONTENTS · 2014-09-30 · TABLE OF CONTENTS Notice of ... Clorsulon, Ivermectin and...

TABLE OF CONTENTS

Notice of Registrations Agricultural Chemical Products Page 4 Veterinary Chemical Products 4

Notice – New Agricultural & Veterinary Active Constituents Spinetoram Page 17 Notice – New Agricultural & Veterinary Chemical Products Spineotram Page 20 [Delegate Insecticide]

Clorsulon, Ivermectin and Nitroxynil Page 24 [Virbac Nitromec Injection Endectocide and Flukicide for Cattle]

Other Notices Addendum List of Approved Active Constituents Page 27 Application Summaries Page 30 Licensing of Veterinary Chemical Manufacturers Page 32 Recall of Unregistered Agricultural Chemical Products Page 38 Amendment to the MRL Standard 1L Page 39 Amendment to the MRL Standard 2L Page 43

NOTICE OF REGISTRATION OF AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS 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 registration in respect of the following products, with effect from the dates shown. AGRICULTURAL CHEMICAL PRODUCTS 1. RESTRICTED PRODUCT: Product Name: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Label Approval No: “No entries” 2. AGRICULTURAL PRODUCTS

BASED ON NEW ACTIVE CONSTITUENTS:

Product Name: Convenia Active Constituent/s: 80 mg/mL cefovecin as sodium salt Applicant Name: Pfizer Animal Health A Div of Pfizer Australia Pty Ltd Applicant ACN: 008 422 348 Summary of Use: For the treatment of urinary tract, skin and soft tissue infections sensitive to cefovecin in dogs and cats. Date of Registration: 17 July 2008 Label Approval No: 60461/10/0508, 60461/0508 3. AGRICULTURAL PRODUCTS

BASED ON EXISTING ACTIVE CONSTITUENTS:

Product Name: Up-Root 240 EC Selective Herbicide Active Constituent/s: 240 g/L clethodim Applicant Name: United Phosphorus Ltd Applicant ACN: 066 391 384 Summary of Use: For control of certain grass weeds in agricultural situations. Date of Registration: 17 June 2008 Label Approval No: 62783/5L/0408, 62783/10L/0408, 62783/0408

Product Name: Accomplish 400 WG Herbicide Active Constituent/s: 400 g/kg tralkoxydim Applicant Name: United Phosphorus Ltd Applicant ACN: 066 391 384 Summary of Use: For the control of wild oats and annual ryegrass and suppression of annual phalaris in wheat, barley, rye and triticale. Date of Registration: 17 June 2008 Label Approval No: 62780/5kg/0308, 62780/0308 Product Name: Chemforce Paraquat 250 Herbicide Active Constituent/s: 250 g/L paraquat present as paraquat dichloride Applicant Name: Frank Vanderkley & Paul Richards T/A Chemforce Australia Summary of Use: For the control of a wide range of grasses and broadleaf weeds. Date of Registration: 17 June 2008 Label Approval No: 62540/20L/1207, 62540/110L/1207, 62540/200L/1207, 62540/1207 Product Name: OzCrop Diclofop-Methyl 375 EC Herbicide Active Constituent/s: 375 g/L diclofop-methyl Applicant Name: CMS Trade Pty Ltd Applicant ACN: 086 927 157 Summary of Use: For use in wheat, linseed, peas and other crops for the the post-emergent control of annual ryegrass, common barb grass and wild oats and for use in turf for the control of crowsfoot grass. Date of Registration: 18 June 2008 Label Approval No: 62881/10/0408, 62881/20/0408, 62881/110L/0408, 62881/110/0408, 62881/0408 Product Name: Wattyl Protective And Marine Coatings Seapro Plus 100 Antifouling Active Constituent/s: 172 g/L copper present as cuprous thiocyanate, 65 g/L diuron Applicant Name: Wattyl Australia Pty Ltd Applicant ACN: 000 035 914 Summary of Use: For control of marine growth on vessels. Date of Registration: 19 June 2008 Label Approval No: 62940/1-20 BLUE/0508, 62940/1-20 BLACK/0508 Product Name: Smart Clethodim 240EC Herbicide Active Constituent/s: 240 g/L clethodim Applicant Name: Crop Smart Pty Ltd

Applicant ACN: 093 927 961 Summary of Use: For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas, cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans. Date of Registration: 19 June 2008 Label Approval No: 62564/1L/1107, 62564/5L/1107, 62564/10L/1107, 62564/20L/1107, 62564/60L/1107, 62564/110L/1107, 62564/1107 Product Name: Bioweed Herbicide Concentrate Active Constituent/s: 680 g/L pine oil Applicant Name: Certified Organics (Aust) Pty Ltd Applicant ACN: 099 114 413 Summary of Use: For the non-selective control of seedling weeds and grasses and for the suppression of established weeds. Date of Registration: 19 June 2008 Label Approval No: 62367/15-942L/0508 Product Name: 4Farmers MCPA 500 Selective Herbicide Active Constituent/s: 500 g/L MCPA present as the dimethylamine salt Applicant Name: 4 Farmers Pty Ltd Applicant ACN: 067 443 485 Summary of Use: For the selective control of broadleaf weeds in cereals, linseed, pastures, sugar cane and turf. Date of Registration: 20 June 2008 Label Approval No: 62337/20L/0208, 62337/100L/0208, 62337/110L/0208, 62337/120L/0208, 62337/200L/0208, 62337/1000L/0208, 62337/0208 Product Name: Genfarm QPE 100 Herbicide Active Constituent/s: 99.5 g/L quizalofop-p-ethyl Applicant Name: Genfarm Crop Protection Pty Ltd Applicant ACN: 115 327 378 Summary of Use: For the control of certain grass weeds in broadleaf crops. Date of Registration: 23 June 2008 Label Approval No: 62508/5L/0608, 62508/10L/0608, 62508/20/0608, 62508/A/0608, 62508/B/0608 Product Name: Trio Wetta 1000 Agricultural Wetting Agent Active Constituent/s: 1000 g/L alcohol alkoxylate

Applicant Name: 5 Heads Pty Ltd T/A Trio Manufacturing Applicant ACN: 098 396 546 Summary of Use: For use as a wetting agent to enchance the herbicide activity. Date of Registration: 23 June 2008 Label Approval No: 62473/5L/1007, 62473/20L/1007, 62473/25L/1007, 62473/110L/1007, 62473/200L/1007 Product Name: Microtech 7000 General Purpose Disinfectant Active Constituent/s: 4 g/L poly(hexamethylene biguanide) hydrochloride, 54 g/L benzalkonium chloride Applicant Name: Artech Technologies Pty Ltd Applicant ACN: 104 264 673 Summary of Use: General purpose disinfectant for application to all hard surfaces, equipment and airspaces. Date of Registration: 24 June 2008 Label Approval No: 62103/5L/0508, 62103/20L/0508 Product Name: Country Fluroxypyr Herbicide Active Constituent/s: 200 g/L fluroxypyr as the methyl heptyl ester. Applicant Name: Accensi Pty Ltd Applicant ACN: 079 875 184 Summary of Use: For the control of a wide range of broadleaf weeds in agricultural crops and for the control of woody weeds in non-crop areas and other situations. Date of Registration: 25 June 2008 Label Approval No: 62603/1107, 62603/1-10L/1107, 62603/20-1000L/1107 Product Name: Mortein Do-It-Yourself Professional Indoor Surface Spray Same Technology Used By Professionals Household Protection Active Constituent/s: 0.60 g/L deltamethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: Surface spray for the prevention of insect infestations for up to 6 months in household situations. Date of Registration: 25 June 2008 Label Approval No: 62413/1L/0408 Product Name: Hussar OD Selective Herbicide Active Constituent/s: 100 g/L iodosulfuron-methyl-sodium, 300 mefenpyr diethyl

Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: For control and suppression of a wide range of grass and broadleaf weeds in wheat. Date of Registration: 27 June 2008 Label Approval No: 61992/3/0508, 61992/0508 Product Name: Barmac BTI 1200 Biological Mosquito Larvicide Active Constituent/s: Bacillus thuringiensis subspecies israelensis serotype H14 Applicant Name: Barmac Industries Pty Ltd Applicant ACN: 009 674 953 Summary of Use: For control of mosquito larvae in salt and fresh water breeding areas by ground or aerial application by Ultra Low Volume techniques or diluted with water. Date of Registration: 1 July 2008 Label Approval No: 62305/10/0108 Product Name: Titan Picloram + Triclopyr 400 Herbicide Active Constituent/s: 100 g/L picloram present as the hexyloxypropylamine salt, 300 g/L triclopyr present as the butoxyethyl ester Applicant Name: Titan Ag Pty Ltd Applicant ACN: 122 081 574 Summary of Use: For control of a range of environmental and noxious woody and herbaceous weeds. Date of Registration: 1 July 2008 Label Approval No: 62484/1L/1207, 62484/1LL/1207, 62484/5L/1207, 62484/10L/1207, 62484/20L/1207, 62484/1207 Product Name: AW Flupropanate Herbicide Active Constituent/s: 745 g/L flupropanate present as the sodium salt Applicant Name: Agri West Pty Limited Applicant ACN: 108 899 181 Summary of Use: For control of certain grasses in industrial areas, pastures and non-crop situations. Date of Registration: 1 July 2008 Label Approval No: 62827/1L/0208, 62827/5L/0208, 62827/20L/0208, 62827/0208 Product Name: Mancozz 750 WG Fungicide Active Constituent/s: 750 g/kg mancozeb Applicant Name: Hextar Chemicals Pty Ltd

Applicant ACN: 114 525 709 Summary of Use: For control of certain fungal diseases of fruit, field crops, tobacco, turf, vegetables and ornamentals. Date of Registration: 1 July 2008 Label Approval No: 62791/5kg/0208, 62791/10kg/0208, 62791/15kg/0208, 62791/20kg/0208, 62791/25kg/0208, 62791/0208 Product Name: Biopren 4GR Mosquito Larvicide Active Constituent/s: 4 g/kg (s)-methoprene Applicant Name: Babolna Bioenvironmental Centre Ltd Summary of Use: For the prevention of adult mosquito emergence in freshwater swamps and marshes, salt and fresh water lagoons, salt marshes, mangrove swamps, estuarine areas, woodland pools, and any natural water holding feature. Date of Registration: 1 July 2008 Label Approval No: 62018/20KG/0208 Product Name: Airomist Pest Insect Control With Natural Pyrethrins Active Constituent/s: 42.3 g/kg piperonyl butoxide, 9 g/kg pyrethrins Applicant Name: Ardrich Limited Summary of Use: For control of flying insects in household situations. Date of Registration: 1 July 2008 Label Approval No: 62543/150G/0308 Product Name: Spalding Canola Oil Crop Spray Oil Concentrate Active Constituent/s: 840 g/L canola oil Applicant Name: Spalding Holdings Pty Ltd Applicant ACN: 010 155 852 Summary of Use: For the use as an adjuvant to improve chemical uptake and rainfastness, improve drift control and droplet deposition and to assist with odour reduction and evaporation. Date of Registration: 1 July 2008 Label Approval No: 62831/5L/0208, 62831/20L/0208, 62831/110L/0208, 62831/200L/0208, 62831/1000L/0208 Product Name: Raid Commercial Automatic Insect Control System Active Constituent/s: 60 g/kg piperonyl butoxide, 14 g/kg pyrethrins Applicant Name: S.C. Johnson & Son Pty Ltd Applicant ACN: 000 021 009 Summary of Use: For the control of flies and insects.

Date of Registration: 1 July 2008 Label Approval No: 63083/305G/0508 Product Name: Termguard Maxxthor 100 Water-Based Termiticide And Insecticide Active Constituent/s: 100 g/L bifenthrin Applicant Name: Ensystex Australasia Pty Ltd Applicant ACN: 102 221 965 Summary of Use: For chemical soil barriers for the management of subterranean termites and the control of a range of other urban pests. Date of Registration: 1 July 2008 Label Approval No: 62968/5L/0408, 62968/0408 Product Name: Baygon Targetkill Crawling Insect Spray Antibacterial Active Constituent/s: 0.70 g/kg imiprothrin, 2 g/kg cypermethrin Applicant Name: S.C. Johnson & Son Pty Ltd Applicant ACN: 000 021 009 Summary of Use: For the control of crawling insects. Date of Registration: 1 July 2008 Label Approval No: 63081/250g/0508, 63081/350g/0508 Product Name: AW Growler 450 Herbicide Active Constituent/s: 450 g/L glyphosate present as the isopropylamine salt Applicant Name: Agri West Pty Limited Applicant ACN: 108 899 181 Summary of Use: For control of a broad range of annual and perennial weeds. Date of Registration: 1 July 2008 Label Approval No: 62836/10L/0208, 62836/20L/0208, 62836/110L/0208, 62836/200L/0208, 62836/1000L/0208, 62836/0208 Product Name: Superway 2,4-D Amine 625 Herbicide Active Constituent/s: 625 g/L 2,4-D present as the dimethylamine and diethanolamine salts Applicant Name: Superway Garden Ag & Pest Products Pty Ltd Applicant ACN: 056 553 274 Summary of Use: For control of broadleaf weeds in fallow before direct drilling or sowing of cereals and pastures; and in cereal crops, pastures, sugar cane, peanuts and non-agricultural areas. Date of Registration: 1 July 2008 Label Approval No: 62823/1L/0208, 62823/2.5L/0208, 62823/5L/0208, 62823/10L/0208, 62823/20L/0208,

62823/110L/0208, 62823/200L/0208, 62823/1000L/0208, 62823/0208 Product Name: H2O Pool Chemicals Stabilised Pool Chlorine Active Constituent/s: 560 g/kg chlorine present as sodium dichloroisocyanurate Applicant Name: Kleenco Australia Pty Limited Applicant ACN: 003 131 539 Summary of Use: For the control of algae and bacteria in outdoor pools. Date of Registration: 1 July 2008 Label Approval No: 62953/1/0508, 62953/2/0508, 62953/4/0508, 6953/10/0508, 62953/20/0508¸62953/40/0508, 62953/50/0508 Product Name: Advance Cockroach Gel Bait Active Constituent/s: 0.5 g/kg abamectin Applicant Name: Sorex Ltd Summary of Use: For control of German and American cochroaches in commerical, residential and industrial premises by professional pest control. Date of Registration: 1 July 2008 Label Approval No: 60703/1/0107, 60703/2/0107 Product Name: 4Farmers Trifluralin-Oryzalin 250 EC Selective Herbicide Active Constituent/s: 125 g/L oryzalin, 125g/L trifluralin Applicant Name: 4 Farmers Pty Ltd Applicant ACN: 067 443 485 Summary of Use: For the pre-emergence control of annual ryegrass, phalaris, wireweed (hogweed) and deadnettle in wheat, barley and canola. Date of Registration: 1 July 2008 Label Approval No: 62818/20L/0308, 62818/100L/0308, 62818/110L/0308, 62818/120L/0308, 62818/200L/0308, 62818/1000L/0308, 62818/0308 Product Name: Macspred Glymac Dri 700 Herbicide Active Constituent/s: 700 g/kg glyphosate present as the mono-ammonium salt Applicant Name: Macspred Pty Ltd Applicant ACN: 001 029 495 Summary of Use: For control of many annual and perennial weeds in a range of situations. Date of Registration: 1 July 2008 Label Approval No: 61986/10/0408, 61986/0408

Product Name: Pets Quality Aquarium Products Algae Blocks Active Constituent/s: 1.875 g/kg diuron Applicant Name: Australian Pet Supplies Pty Ltd Applicant ACN: 000 316 790 Summary of Use: For control of algae and green water in aquariums and fish bowls. Date of Registration: 1 July 2008 Label Approval No: 59978/20g/0508 Product Name: Country Metalaxyl Systemic Fungicide Granules Active Constituent/s: 50 g/kg metalaxyl Applicant Name: Accensi Pty Ltd Applicant ACN: 079 875 184 Summary of Use: For the control of phytophthora root rot of avocados, phytophthora root rot and trunk canker of macadamia nuts, phytophthora root rot on peaches and damping off of certain vegetable crops. Date of Registration: 1 July 2008 Label Approval No: 62579/5kg/1107, 62579/10kg/1107, 62579/15-25kg/1107 Product Name: Spa Protector Pool & Spa Sanitiser Active Constituent/s: 598 g/L hydrogen peroxide Applicant Name: Pool Ranger Pty Limited Applicant ACN: 078 758 040 Summary of Use: For use in swimming pools and spas for the control od algae and bacteria. Date of Registration: 1 July 2008 Label Approval No: 62939/5/0408, 62939/20/0408 Product Name: Grandpar K4 Cane Herbicide Active Constituent/s: 132 g/kg hexazinone, 468 g/kg diuron Applicant Name: Sipcam Pacific Australia Pty Ltd Applicant ACN: 073 176 888 Summary of Use: For control of a wide range of annual and perennial grasses, broadleaf weeds and vines in established sugar cane. Date of Registration: 1 July 2008 Label Approval No: 62797/2/0508, 62797/10KgA/0508, 62797/10Kg/0508, 62797/12Kg/0508, 62797/15Kg/0508 Product Name: Raid Automatic Insect Control System Indoor/Outdoor Active Constituent/s: 45 g/kg piperonyl butoxide, 4.4 g/kg allethrin 20:80, 1.1 g/kg pyrethrins, 3.5 g/kg tetramethrin

Applicant Name: S.C. Johnson & Son Pty Ltd Applicant ACN: 000 021 009 Summary of Use: For the control of flying and crawling insects. Date of Registration: 1 July 2008 Label Approval No: 63084/185G/0608, 63084/305G/0608 Product Name: Ospray MCPA 750 Herbicide Active Constituent/s: 750 g/L MCPA present as the dimethylamine salt Applicant Name: Ospray Pty Ltd Applicant ACN: 110 199 169 Summary of Use: For use in cereals, linseed, pastures, rice, sugar cane and turf for the selective control of broadleaf weeds. Date of Registration: 1 July 2008 Label Approval No: 62913/20/0408, 62913/110/0408, 62913/1000/0408, 62913/0408 Product Name: Hometeam Eco-Bor Mould Fungicide Active Constituent/s: 23 g/L boron present as disodium octaborate tetrahydrate, 22 g/L benzalkonium chloride Applicant Name: Hometeam Australia Pty Ltd Applicant ACN: 000 217 568 Summary of Use: For the treatment of surfaces attacked or susceptible to mould, algae, fungus, lichen and moss. Date of Registration: 1 July 2008 Label Approval No: 62136/1L/0508, 62136/5L/0508, 62136/10L/0508¸62136/20L/0508, 62136/200L/0508 Product Name: Agroshine Triasulfuron 750 WG Selective Herbicide Active Constituent/s: 750 g/kg triasulfuron Applicant Name: Agroshine Australia Pty Ltd Applicant ACN: 105 873 023 Summary of Use: For pre-plant control of annual ryegrass, paradoxa grass and certain broadleaf weeds in wheat and for post-emergent control of wild radish in wheat, oats and barley. Date of Registration: 1 July 2008 Label Approval No: 62488/1KG/0208, 62488/2KG/0208, 62488/0208 Product Name: Country Tebuconazole 430 Fungicide Active Constituent/s: 430 g/L tebuconazole Applicant Name: Accensi Pty Ltd Applicant ACN: 079 875 184

Summary of Use: For the control of leaf spot and leaf speckle on bananas; rust, leaf spot and net blotch of peanuts; foliar diseases on cereal crops; and other diseases on beans, peas, onions, pawpaw, pyrethrum and ryegrass seed crops and fescue seed crops. Date of Registration: 1 July 2008 Label Approval No: 62612/1–10L/1107, 62612/20–200/1107, 62612/110–1000/1107 Product Name: Suria 450 CT Non-Selective, Translocated Herbicide Active Constituent/s: 450 g/L glyphosate present as the isopropylamine salt Applicant Name: Hextar Chemicals Pty Ltd Applicant ACN: 114 525 709 Summary of Use: For the control of a wide range of annual and perennial weeds in a wide variety of situations. Date of Registration: 1 July 2008 Label Approval No: 62243/5L/0308, 62243/20L/0308, 62243/110L/0308, 62243/120L/0308, 62243/200L/0308, 62243/800L/0308, 62243/1000L/0308, 62243/BULK/0308, 62243/0308 Product Name: Hovex Home Protection Crawling Insect Spray Active Constituent/s: 0.70 g/kg imiprothrin, 2 g/kg cypermethrin Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: For protection against a range of crawling insects. Date of Registration: 1 July 2008 Label Approval No: 62773/350/0408 Product Name: Distance Ant Bait Active Constituent/s: 5 g/kg pyriproxyfen Applicant Name: Sumitomo Chemical Australia Pty Limited Applicant ACN: 081 096 255 Summary of Use: An insect growth regulator bait for the control of red imported fire ants. Date of Registration: 1 July 2008 Label Approval No: 55784/500g/0408, 55784/1kg/0408, 55784/12.5kg/0408 Product Name: Spalding Surfactant 700 Active Constituent/s: 350 g/L soyal phospholipids, 350 g/L propionic acid Applicant Name: Spalding Holdings Pty Ltd Applicant ACN: 010 155 852 Summary of Use: For use as a surfactant. Date of Registration: 1 July 2008 Label Approval No: 62810/1L/0208, 62810/5L/0208, 62810/20L/0208,

62810/110L/0208, 62810/200L/0208, 62810/1000L/0208 Product Name: 4Farmers Fenamiphos 400 Nematicide And Insecticide Active Constituent/s: 400 g/L fenamiphos Applicant Name: 4 Farmers Pty Ltd Applicant ACN: 067 443 485 Summary of Use: For control of nematodes and sucking insects in crops and turf. Date of Registration: 1 July 2008 Label Approval No: 62574/5L/0408, 62574/20L/0408, 62574/0408 Product Name: Garden Pro Outdoor Insect Spray Active Constituent/s: 0.50 g/L bifenthrin Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: Surface spray for the control of crawling and flying insects around the home. Date of Registration: 1 July 2008 Label Approval No: 61280/2L/0208, 61280/3L/0208, 61280/4L/0208, 61280/5L/0208 Product Name: Genfarm 2,4-D LV Ester 680 Herbicide Active Constituent/s: 680 g/L 2,4-D as the ethyl hexyl ester Applicant Name: Genfarm Crop Protection Pty Ltd Applicant ACN: 115 327 378 Summary of Use: For the control of various weeds in crops, pastures and non-agricultural areas. Date of Registration: 2 July 2008 Label Approval No: 62684/5L/0108, 62684/20L/0108, 62684/100L/0108, 62684/100LA/0108, 62684/100LB/0108, 62684/1000L/0108, 62684/5Lbook/0108, 62684/0108 Product Name: Earthcare Liquid GA 100 Plant Growth Regulator Active Constituent/s: 100 g/L gibberellic acid Applicant Name: Seasol International Pty Ltd Applicant ACN: 006 490 240 Summary of Use: For promoting harvest effects on certain varieties of grapes, citrus and prunes. Date of Registration: 2 July 2008 Label Approval No: 62002/500mL/0308, 62002/1L/0308, 62002/5L/0308, 62002/10L/0308, 62002/20L/0308, 62002/0308

Product Name: Nufarm Pristine Fungicide Active Constituent/s: 252 g/kg boscalid, 128 g/kg pyraclostrobin Applicant Name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of Use: A fungicide for the control of blackspot and powdery mildew in apples. Date of Registration: 3 July 2008 Label Approval No: 62974/1-10kg/0508 Product Name: Allfire Chlorpyrifos 500 Insecticide Active Constituent/s: 500 g/L chlorpyrifos Applicant Name: Agvantage Pty Ltd Applicant ACN: 097 970 280 Summary of Use: For the control of certain insect pests in fruit, vegetables, field crops and pasture and the control of Argentine Ant in agricultural, domestic, commercial and industrial situations. Date of Registration: 3 July 2008 Label Approval No: 62909/1/0308, 62909/5/0308, 62909/20/0308, 62909/100/0308, 62909/200/0308, 62909/0308 Product Name: Aqua Pure Low Residue Granular Pool Chlorine Active Constituent/s: 650 g/kg chlorine (Cl) present as calcium hypochlorite Applicant Name: Pool Products of Australia Pty Ltd Applicant ACN: 085 385 511 Summary of Use: For the control of algae and bacteria in swimming pools. Date of Registration: 3 July 2008 Label Approval No: 62893/500g/0408, 62893/1kg/0408, 62893/2kg/0408, 62893/4kg/0408, 62893/10kg/0408, 62893/20kg/0408, 62893/40kg/0408 Product Name: Aqua Pure Liquid Chlorine Active Constituent/s: 125 g/L chlorine (Cl) present as sodium hypochlorite Applicant Name: Pool Products of Australia Pty Ltd Applicant ACN: 085 385 511 Summary of Use: Liquid product for control of algae and bacteria in swimming pools and spas. Date of Registration: 3 July 2008 Label Approval No: 62907/5L/0408, 62907/10L/0408, 62907/15L/0408, 62907/20L/0408, 62907/25L/0408 Product Name: Maxcel Plant Growth Regulator Active Constituent/s: 20 g/L 6-benzyladenine.

Applicant Name: Valent Biosciences A Div of Sumitomo Chemical Australia Pty Limited Applicant ACN: 081 096 255 Summary of Use: A plant growth regulator for reducing fruit set, increasing fruit size and improving firmness of harvested apples. Date of Registration: 4 July 2008 Label Approval No: 61799/1-20L/0608 Product Name: Greenseal Pruning Wound Dressing Active Constituent/s: 10 g/L tebuconazole Applicant Name: Primaxa Limited Summary of Use: For the control of Eutypa dieback in grapevines. Date of Registration: 4 July 2008 Label Approval No: 61873/2-10L/0608 Product Name: Hometeam Eco-Bor Industrial Timber Treatment Active Constituent/s: 111 g/L boron present as disodium octaborate tetrahydrate, 13.2 g/L benzalkonium chloride Applicant Name: Hometeam Australia Pty Ltd Applicant ACN: 111 217 568 Summary of Use: For treatment of timber against decay and insects. Date of Registration: 7 July 2008 Label Approval No: 62138/1L/0508, 62138/5L/0508, 62138/10L/0508, 62138/20L/0508, 62138/200L/0508 Product Name: Akopic 240 EC Herbicide Active Constituent/s: 60 g/L cloquintocet-mexyl, 240 g/L clodinafop-propargyl Applicant Name: Aako Australia Pty Limited Applicant ACN: 122 279 109 Summary of Use: For the control of wild oats, paradoxa grass, canary grass and annual ryegrass in wheat. Date of Registration: 7 July 2008 Label Approval No: 63087/1/0508, 63087/5/0508, 63087/10/0508, 63087/20/0508, 63087/0508 Product Name: Nuturf Transact Fungicide Active Constituent/s: 250 g/L iprodione Applicant Name: Nuturf Australia Pty Limited Applicant ACN: 115 077 800 Summary of Use: For use in ornamentals and recreational turf. Date of Registration: 7 July 2008 Label Approval No: 62775/5L/0308 Product Name: Aqua Pure Stabilized Pool Chlorine

Active Constituent/s: 560 g/kg chlorine present as sodium dichloroisocyanurate. Applicant Name: Pool Products of Australia Pty Ltd Applicant ACN: 085 385 511 Summary of Use: For the control of algae and bacteria in swimming pools. Date of Registration: 7 July 2008 Label Approval No: 62899/500g/0408, 62899/1kg/0408, 62899/2kg/0408, 62899/4kg/0408, 62899/10kg/0408, 62899/25kg/0408, 62899/50kg/0408 Product Name: Mortein Do-It-Yourself Surface Spray Outdoor Same Technology Used By Professionals Household Protection Active Constituent/s: 0.6 g/L deltamethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: For control of crawling insects in outdoor household situations. Date of Registration: 7 July 2008 Label Approval No: 62985/2L/0608 Product Name: Superway Tri-Pic Herbicide Active Constituent/s: 100 g/L picloram present as the hexyloxypropylamine salt, 300 g/L triclopyr present as the butoxyethyl ester Applicant Name: Superway Garden Ag & Pest Products Pty Ltd Applicant ACN: 056 553 274 Summary of Use: For control of a range of environmental and noxious woody and herbaceous weeds. Date of Registration: 8 July 2008 Label Approval No: 62824/1L/0208, 62824/2.5L/0208, 62824/5L/0208, 62824/10L/0208, 62824/20L/0208, 62824/110L/0208, 62824/200L/0208, 62824/0208 Product Name: Mortein Do-It-Yourself Surface Spray Indoor Same Technology Used By Professionals Household Protection Active Constituent/s: 0.6 g/L deltamethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: For the control of crawling insects in household situations. Date of Registration: 9 July 2008 Label Approval No: 62986/1L/0608 Product Name: AW Mincer 750 Herbicide Active Constituent/s: 750 g/kg metribuzin Applicant Name: Agri West Pty Limited

Applicant ACN: 108 899 181 Summary of Use: For selective weed control in potatoes, peas, soybeans, faba beans, tomatoes, barley, and white lupins. Date of Registration: 9 July 2008 Label Approval No: 62828/5kg/0208, 62828/10kg/0208, 62828/20kg/0208, 62828/0208 Product Name: Dow Agrosciences Dimension Herbicide Active Constituent/s: 240 g/L dithiopyr Applicant Name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of Use: For selective pre-emergent and post-emergent weed control of summer grass and certain other annual grasses and broadleaf weeds in turf. Date of Registration: 10 July 2008 Label Approval No: 62298/1/0708, 62298/2/0708, 62298/5/0708, 62298/10/0708, 62298/20/0708 Product Name: Macphersons Glyphosate Hi-Light Blue Herbicide Active Constituent/s: 700 g/kg glyphosate present as the mono-ammonium salt. Applicant Name: Ronic International Pty Limited Applicant ACN: 101 193 131 Summary of Use: For the control of annual, perennial and aquatic weeds in forestry, pasture, designated aquatic situations, commercial, industrial and public service areas. Date of Registration: 14 July 2008 Label Approval No: 61985/1KGW/1007, 61985/1KGP/1007, 61985/3KGP/1007, 61985/3KGW/1007, 61985/5KG/1007, 61985/10KG/1007, 61985/15KG/1007, 61985/500GP/1007, 61985/500GW/1007, 61985/1007 Product Name: Hovex Ant Granules Active Constituent/s: 2 g/kg bifenthrin Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: For control of ants, fleas and ticks in the home garden. Date of Registration: 15 July 2008 Label Approval No: 62781/500g/0408, 62781/1Kg/0408, 62781/2.5Kg/0408 Product Name: Yates Tomato Dust Active Constituent/s: 0.5 g/kg spinosad, 40 g/kg copper present as copper oxychloride, 400 g/kg sulfur as elemental sulfur. Applicant Name: Yates Australia A Div Of Orica Australia Pty Ltd

Applicant ACN: 004 117 828 Summary of Use: For the control of pests and diseases in tomatoes. Date of Registration: 15 July 2008 Label Approval No: 61795/500/0508 Product Name: Country Flutriafol 250 In-Furrow And Foliar Fungicide Active Constituent/s: 250 g/L flutriafol Applicant Name: Accensi Pty Ltd Applicant ACN: 079 875 184 Summary of Use: For the control of certain fungal diseases on wheat, barley and canola when mixed with fertiliser or applied as a foliar spray. Date of Registration: 16 July 2008 Label Approval No: 62589/1L/1107, 62589/1LL/1107, 62589/5-10-20-200L/1107, 62589/5-10-20-200LL/1107, 62589/100-110-1000L/1107, 62589/100-110-1000LL/1107 Product Name: Hovex Home Protection Ant Granules Active Constituent/s: 2 g/kg bifenthrin Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: For control of ants, fleas and ticks in the home garden. Date of Registration: 16 July 2008 Label Approval No: 62779/500g/0408, 62779/1Kg/0408, 62779/2.5Kg/0408 Product Name: Mortein Do-It-Yourself Control Bomb Indoor Active Constituent/s: 0.77 g/kg fenoxycarb, 10 g/kg permethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: For houshold crawling insect control. Date of Registration: 16 July 2008 Label Approval No: 62992/125g/0608, 62992/375g/0608 Product Name: Mortein Do-It-Yourself Ant Killer Active Constituent/s: 2 g/kg bifenthrin. Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: For outdoor household use for the control of ants. Date of Registration: 17 July 2008 Label Approval No: 62987/1kg/0608 Product Name: Hovex Extra Strength Flying Insect Spray

Active Constituent/s: 6.36 g/kg n-octyl bicycloheptene dicarboximide, 4.34 g/kg piperonyl butoxide, 0.50 g/kg phenothrin 20:80, 2.16 g/kg tetramethrin 20:80 Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: For the control of certain flying insects Date of Registration: 17 July 2008 Label Approval No: 62772/250g/0708, 62772/350g/0708 4. VARIATIONS Re-Issue 59591 Product Name: Osmose Determite Glue Line Insecticide Applicant Name: Osmose Australia Pty Ltd Applicant ACN: 088 260 575 Summary of Variation: Variation of label approval to add new use in plywood and LVL made using Lyctus susceptible timbers of veneer thickness of 2.2mm or less. Date of Variation: 12 June 2008 Label Approval No: 59591/1L/0408, 59591/5L/0408, 59591/20L/0408, 59591/200L/0408, 59591/1000L/0408, 59591/0408 Re-Issue 54934 Product Name: Blitzem! Insect Killer Concentrate Applicant Name: Orica Australia Pty Ltd Applicant ACN: 004 117 828 Summary of Variation: Variation of the label approval to change the product name from Yates Ant, Roach & Spider Killer to Blitzem! Insect Killer Concentrate. Date of Variation: 21 May 2008 Label Approval No: 54934/200mL/1107, 54934/100mL/1107, 54934/500mL/1107 Product Name: Mortein Easy Reach Surface Spray Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Variation: Variation of registration to change product name from Mortein Easy Reach Surface Spray Kills Cockroaches Fast to Mortein Easy Reach Surface Spray And Other Minor Label Changes. Date of Variation: 17 June 2008 Label Approval No: 55217/250g/0508, 55217/350g/0508

Product Name: Multicrop Ecopest Oil Ready-To-Use Insect Spray Applicant Name: SBC Asia Pacific Pty Ltd Applicant ACN: 099 546 415 Summary of Variation: Variation of the label approval to change product name from Ecopest Oil Ready-To-Use Insect Spray to Multicrop Ecopest Oil Ready-To-Use Insect Spray; to change the shape of the existing 750mL packsize and add an additional packsize 1L. Date of Variation: 17 June 2008 Label Approval No: 60340/750ml/0108, 60340/1L/0108 Product Name: United Farmers Blade 240EC Herbicide Applicant Name: United Farmers Co-Operative Company Ltd Summary of Variation: Variation of registration to change product name from United Farmers Clethodim 240EC Herbicide to United Farmers Blade 240EC Herbicide; add additional sites of formulation. Date of Variation: 17 June 2008 Label Approval No: 60717/10L/0408, 60717/20L/0408, 60717/0408 Product Name: Blitzem! Ant Flea & Tick Killer Applicant Name: Yates Australia A Div Of Orica Australia Pty Ltd Applicant ACN: 004 117 828 Summary of Variation: Variation of registration to change product name from Blitz-Em! Ant Flea & Tick Killer to Blitzem! Ant Flea & Tick Killer; other minor label changes. Date of Variation: 18 June 2008 Label Approval No: 60360/600/1107 Product Name: United Farmers Sanction 99.5EC Herbicide Applicant Name: United Farmers Co-Operative Company Ltd Summary of Variation: Variation of registration to change product name from United Farmers Quizalofop-P-Ethyl 100 EC Herbicide to United Farmers Sanction 99.5ec Herbicide; addtional formulation sites and formulation; update label layout. Date of Variation: 19 June 2008 Label Approval No: 58610/5L/0208, 58610/10L/0208, 58610/20L/0208, 58610/110L/0208, 58610/200L/0208, 58610/1000L/0208, 58610/0208 Product Name: Titan Bifenthrin 100 Termiticide & Insecticide Applicant Name: Titan AG Pty Ltd

Applicant ACN: 122 081 574 Summary of Variation: Change of product name from QM Profen 100 Termiticide And Insecticide to Titan Bifenthrin 100 Termiticide & Insecticide. Date of Variation: 1 July 2008 Label Approval No: 57837/1-200/0207, 57837/0207 Product Name: Mortein Rat Kill With Flea Eliminator Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Variation: Change of product name from Mortein Rat Kill to Mortein Rat Kill With Flea Eliminator. Date of Variation: 10 July 2008 Label Approval No: 58661/15g/0208, 58661/30g/0208, 58661/60g/0208 5. RESTRICTED PRODUCT

VARIATION Product Name: Applicant Name: Applicant ACN: Summary of Variation: Date of Variation: Label Approval No: “No entries”

NOTICE OF REGISTRATION OF AGRICULTURAL AND VETERINARY

CHEMICAL PRODUCTS

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 registration in respect of the following products, with effect from the dates shown.

VETERINARY CHEMICAL PRODUCTS

1. RESTRICTED PRODUCT: Product Name: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Label Approval No: “No entries” 2. VETERINARY PRODUCTS BASED ON

NEW ACTIVE CONSTITUENTS: Product Name: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Label Approval No: “No entries” 3. VETERINARY PRODUCTS BASED ON

EXISTING ACTIVE CONSTITUENTS: Product Name: Outback Vet Prime-D Nutrient Uptake Powder For Dogs Active Constituent/s: 718.8 g/kg sodium bentonite, 7.2 g/kg digestive enzymes (with lipase, protease & amylase) Applicant Name: Nature Vet Pty Limited Applicant ACN: 002 692 426 Summary of Use: For the reduction of faecal odour and fluid bowel motions of canine diets. Date of Registration: 1 July 2008 Label Approval No: 62666/600G/0308 Product Name: Paw Pure Animal Wellbeing Probiotic Powder Active Constituent/s: 1 mg/g calcium ascorbate, 10,000,000 cfu/g lactobacillus acidophilus, <500 cfu/g saccharomyces boulardii, <500 cfu/g

saccharomyces cerevisiae Applicant Name: Pure Animal Wellbeing Pty Limited Applicant ACN: 114 807 475 Summary of Use: For improving intestinal balance and general health in dogs. Date of Registration: 1 July 2008 Label Approval No: 62580/150g/0308, 62580/300g/0308 Product Name: Outback Vet Joint Maintain Powder For Dogs Active Constituent/s: Each 2.5g contains: 400 mg chondroitin sulfate, 500 mg glucosamine hydrochloride. Applicant Name: Nature Vet Pty Limited Applicant ACN: 002 692 426 Summary of Use: For the reduction of non-infectious joint inflammation in dogs. Date of Registration: 1 July 2008 Label Approval No: 62825/400G/0308 Product Name: Tilmovet 200 Granular Premix Active Constituent/s: 200 g/kg tilmicosin as the tilmicosin phosphate Applicant Name: Huvepharma Summary of Use: For the control of bacterial respiratory disease in pigs caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida Date of Registration: 1 July 2008 Label Approval No: 61874/20G/0208, 61874/100G/0208, 61874/500G/0208, 61874/1 KG/0208¸61874/10 KG/0208, 61874/25 KG/0208 Product Name: Nature's Answer Glucosamine Tablets Nature's Answer Active Constituent/s: Each tablet contains 500 mg glucosamine hydrochloride Applicant Name: Mavlab Pty Ltd Applicant ACN: 009 708 187 Summary of Use: Oral tablet product for use in dogs where long term use may help to reduce non-infectious joint inflammation. Date of Registration: 1 July 2008 Label Approval No: 61587/100/0508, 61587/250/0508, 61587/500/0508 Product Name: Nature's Pet Joint Formula Powder Active Constituent/s: 600 g/kg green lipped mussel, 200 g/kg shark cartilage, 200 g/kg abalone Applicant Name: V M Supplies Pty Ltd Applicant ACN: 007 002 495 Summary of Use: May help in the relief of arthritic symptons in dogs Date of Registration: 1 July 2008

Label Approval No: 60526/250g-1kg/0608, 60526/1kg/0608 Product Name: Imax Soluble Wormer For Pigs Active Constituent/s: 10 mg/mL ivermectin. Applicant Name: Bomac Research Pty Ltd Applicant ACN: 125 425 149 Summary of Use: For the treatment and control of gastrointestinal roundworms, kidney worms and lungworms in pigs. Date of Registration: 3 July 2008 Label Approval No: 60022/100mL/0208, 60022/2L/0208 Product Name: Coalition Mineralised Sheep Drench Active Constituent/s: 8.6 g/L zinc EDTA, 80 g/L levamisole hydrochloride, 2.9 g/L cobalt EDTA, 2.4 g/L sodium selenate, 45.3 g/L oxfendazole. Applicant Name: Norbrook Laboratories Australia Pty Limited Applicant ACN: 080 972 596 Summary of Use: An oral solution for the control of gastrointestinal nematodes including macrocyclic lactone, levamisole or benzimidazole resistant strains and to supplement diets which may be deficient in selenium, cobalt and zinc in sheep and lambs. Date of Registration: 4 July 2008 Label Approval No: 62750/8L/0408, 62750/10L/0408, 62750/15L/0408 Product Name: Juroclav 50 Broad Spectrum Antibiotic Tablets Active Constituent/s: Each tablet contains 40 mg amoxicillin as amoxicillin trihydrate, 10 mg clavulanic acid as clavulanate potassium. Applicant Name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of Use: For the treatment of bacterial infections sensitive to clavulanic acid and amoxicillin in dogs and cats. Date of Registration: 10 July 2008 Label Approval No: 61669/100 Tab/0408, 61669/0408 Product Name: Juroclav 250 Broad Spectrum Antibiotic Tablets Active Constituent/s: Each tablet contains 200 mg amoxicillin as amoxicillin trihydrate, 50 mg clavulanic acid as clavulanate potassium. Applicant Name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of Use: For the treatment of bacterial infections sensitive to clavulanic acid and amoxicillin in dogs and cats. Date of Registration: 10 July 2008 Label Approval No: 61670/250 Tab/0408, 61670/0408

Product Name: Juroclav 500 Broad Spectrum Antibiotic Tablets Active Constituent/s: Each tablet contains 400 mg amoxicillin as amoxicillin trihydrate, 100 mg clavulanic acid as clavulanate potassium. Applicant Name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of Use: For the treatment of bacterial infections sensitive to clavulanic acid and amoxicillin in calves and dogs. Date of Registration: 10 July 2008 Label Approval No: 61671/100 Tab/0408, 61671/0408 Product Name: Flukeject Injectable Flukicide For Cattle Active Constituent/s: 100 mg/mL clorsulon. Applicant Name: Novartis Animal Health Australasia Pty Limited Applicant ACN: 076 745 198 Summary of Use: For the treatment and control of clorsulon sensitive adult liver fluke in beef and dairy cattle. Date of Registration: 16 July 2008 Label Approval No: 61621/500mL/0308 4. LISTED REGISTERED CHEMICAL

PRODUCTS Product Name: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Product No: “No entries” 5. VARIATIONS Product Name: Bayer Advantix For Dogs Over 25kg Applicant Name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of Variation: Change to product name from “Advantix For Dogs Over 25kg” to “Bayer Advantix For Dogs Over 25kg” and extension claim to include the repelling of stable (biting) flies (Stomoxys calcitrans). Date of Variation: 24 June 2008 Label Approval No: 58262/1/0707, 58262/3/0707, 58262/6/0707, 58262/0707 Product Name: Bayer Advantix For Dogs 4-10kg Applicant Name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of Variation: Change to product name from “Advantix For Dogs 4-10kg” to

“Bayer Advantix For Dogs 4-10kg” and extension claim to include the repelling of stable (biting) flies (Stomoxys calcitrans). Date of Variation: 25 June 2008 Label Approval No: 58261/1/0707, 58261/3/0707, 58261/6/0707, 58261/0707 Product Name: Urinary S/O With Chicken Feline Applicant Name: Royal Canin Australia Pty Ltd Applicant ACN: 092 020 178 Summary of Variation: Variation to registration to change the product name from “Urinary S/O With Chicken “ To “Urinary S/O With Chicken Feline” and have variations to the label approved. Date of Variation: 25 June 2008 Label Approval No: 58592/100g/0308, 58592/12x100g/0308 Product Name: Bayer Advantix For Puppies And Small Dogs Up To 4kg Applicant Name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of Variation: Change to product name from “Advantix For Puppies And Small Dogs Up to 4kg” to “Bayer Advantix For Puppies And Small Dogs Up To 4kg” and extension claim to include the repelling of stable (biting) flies (Stomoxys calcitrans). Date of Variation: 25 June 2008 Label Approval No: 58259/1/0707, 58259/3/0707, 58259/6/0707, 58259/0707 Product Name: Bayer Advantix For Dogs 10-25kg Applicant Name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of Variation: Change to product name from “Advantix For Dogs 10-25kg” to “Bayer Advantix For Dogs 10-25kg” and extension claim to include the repelling of stable (biting) flies (Stomoxys calcitrans). Date of Variation: 25 June 2008 Label Approval No: 58260/1/0707, 58260/3/0707, 58260/6/0707, 58260/0707 Product Name: Urinary S/O LP 34 Feline Applicant Name: Royal Canin Australia Pty Ltd Applicant ACN: 092 020 178 Summary of Variation: Variation to registration particulars to change the product name from “Urinary S/O LP 34” to “Urinary S/O LP 34 Feline”. Date of Variation: 26 June 2008 Label Approval No: 54491/0.4kg/0308,

54491/1.5kg/0308, 54491/3.5kg/0308, 54491/6kg/0308 Product Name: Renal With Chicken Feline Applicant Name: Royal Canin Australia Pty Ltd Applicant ACN: 092 020 178 Summary of Variation: Variation to registration to change the product name from "Renal S/O With Chicken" to "Renal With Chicken Feline" and have variations to the label approved. Date of Variation: 4 July 2008 Label Approval No: 58591/100g/0308, 58591/12x100g/0308 Product Name: Renal RF 23 Feline Applicant Name: Royal Canin Australia Pty Ltd Applicant ACN: 092 020 178 Summary of Variation: Variation to registration particulars to change name from “Royal Canin/Waltham Renal RF23” to “Renal RF 23 Feline”. Date of Variation: 8 July 2008 Label Approval No: 54489/0.5kg/0308, 54489/2kg/0308, 54489/4kg/0308 6. RESTRICTED PRODUCT VARIATION Product Name: Applicant Name: Applicant ACN: Summary of Variation: Date of Variation: Label Approval No: “No entries”

NOTICE

Spinetoram The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new active constituent, spinetoram. Spinetoram belongs to the spinosyn chemical class of insecticides. Spinetoram is derived through the fermentation of a naturally occurring organism (Saccharopolyspora spinosa) followed by chemical modifications. In accordance with section 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for approval of spinetoram should be granted. Submissions should state the grounds on which they are based. Such grounds should relate only to the matters that the APVMA is required to take into account in deciding whether to grant the approval. Comments must be received by the APVMA within 28 days of the date of this Notice. Particulars of the Active Constituent Common Name: Spinetoram

Major Component (J form) :

IUPAC Name: IUPAC Name:

(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-13-{[(2S,5S,6R)-5-(dimethylamino)-6-methyltetrahydro-2H-pyran-2-yl]oxy}-9-ethyl-14-methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-1H-as-indaceno[3,2-d] oxacyclododecin-2-yl 6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranoside and Minor Component (L form):

(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-13-{[(2S,5S,6R)-5-(dimethylamino)-6-methyltetrahydro-2H-pyran-2-yl]oxy}-9-ethyl-4,14-dimethyl-7,15-dioxo-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-1H-as-indaceno[3,2-d] oxacyclododecin-2-yl 6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranoside

CAS Name: CAS Name:

Major Component (J form):

(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione and Minor Component (L form):

(2R,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione

CAS Number: Major Component (J form): 187166-40-1 Minor Component (L form): 187166-15-0

Molecular Formula: Major Component (J form): C42H69NO10 Minor Component (L form): C43H69NO10

Molecular Weight: Major Component (J form): 748.02 g/mol Minor Component (L form): 760.03 g/mol

Structure: Major component (J form)

Minor component (L form)

O

OO

OO

O

OO

OO

N

O

OO

OO

O

OO

OO

N

Summary of the APVMA’s Evaluation of Spinetoram Active Constituent The Chemistry Section of the APVMA has evaluated the chemistry aspects of the spinetoram active constituent (manufacturing process, quality control procedures, batch analysis results and analytical methods). On the basis of the data provided, it is proposed that the following APVMA Active Constituent Standard be established for spinetoram active constituent: Constituent Specification Level Spinetoram Spinetoram Not less than 820 g/kg Major Component (J form)

Major Component Not less than 50 % Not more than 95 %

Minor Component (L form)

Minor Component Not less than 5 % Not more than 50%

Other compounds of toxicological significance are not expected to occur in spinetoram as a result of the raw materials and the synthetic route used.

The Office of Chemical Safety of the Australian Government Department of Health and Ageing has considered the toxicological aspects of spinetoram, and advised that there are no toxicological objections to the approval of this chemical. The group acceptable daily intake (ADI) for spinetoram is 0.06 mg/kg bw/d based on a no observed adverse effect level (NOAEL) of 6 mg/kg bw/d in a 28 day dietary study in dogs, and using a 100-fold safety factor. No group acute reference dose (ARfD) has been established for spinetoram and no data were submitted to enable an ARfD to be set. The National Drugs and Poisons Schedule Committee (NDPSC) has included spinetoram in Schedule 5 in the Standard for the Uniform Scheduling of Drugs and Poisons. The APVMA accepts the findings and recommendations of its advisers on these criteria. The APVMA is satisfied that the proposed importation and use of spinetoram would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use. Written submissions on the APVMA’s proposal to grant approval for spinetoram should be addressed in writing to: Dr Paul Sethi Principal Chemist Pesticides Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4821 Fax: (02) 6210 4840

NOTICE

spinetoram

[in the product: Delegate Insecticide] The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Dow AgroSciences Australia Limited for registration of a new product containing the active constituent spinetoram. The product is DELEGATE INSECTICIDE. It is for use on pome and stone fruit. In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for registration should be granted. Submissions should state the grounds on which they are based. Such grounds should relate only to matters outlined below that the APVMA is required to take into account in deciding whether to grant the application. Comments must be received by the APVMA within 28 days of the date of this notice. Particulars of Application Proposed product name: DELEGATE INSECTICIDE Applicant company: Dow AgroSciences Australia Limited Name of active constituent: spinetoram Signal heading: Schedule 5 Statement of claims: For the control of codling moth, light brown apple

moth and oriental fruit moth in pome and stone fruit.

Pack sizes: 500g, 1kg, 2.5kg, 5kg Withholding periods: Pome fruit: Do not harvest for 7 days after the last

application Stone fruit: Do not harvest for 3 days after the last

application Grazing: Do not graze any treated area or cut for stockfood.

Summary of the APVMA’s evaluation of DELEGATE INSECTICIDE in accordance with Section 14(3)(e) and (f) of the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 The APVMA has evaluated the application and in its assessment in relation to human and environmental safety under section 14(3)(e) of the Agvet Code, it proposes to determine that: (i) The APVMA is satisfied that the proposed use of DELEGATE INSECTICIDE

would not be harmful to human beings or be an undue hazard to the safety of people exposed to it during its handling and use if used according to the product label directions .

The Australian Government Department of Health and Ageing, Office of Chemical Safety (OCS) has conducted a risk assessment on spinetoram/DELEGATE INSECTICIDE and concluded that it can be used safely. The active constituent has been evaluated and approved and the product is scheduled as 5. The appropriate Signal Heading is on the label. First Aid and Safety Directions for spinetoram have been recommended by OCS and have been included on the label. Spinetoram is not listed on the Australian Safety and Compensation Council Hazardous Substances Information System Database and DELEGATE INSECTICIDE is not a hazardous substance according to the NOHSC Approved Criteria for Classifying Hazardous Substances. The APVMA has considered the findings of the OCS assessment and accepts their recommendations on these criteria.

(ii) The APVMA is satisfied that the proposed use of Delegate Insecticide in accordance with the required label instructions would not be harmful or an undue hazard to the safety of people exposed to residues in food. Residues data were assessed by the APVMA and Maximum Residue Limits (MRLs) and associated Withholding Periods (WHPs) are recommended for Delegate Insecticide when used on pome and stone fruit. Based on the metabolism data provided, the following residue definition is considered appropriate for Delegate Insecticide; “Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L”. Spinetoram MRLs are recommended for pome fruit (0.1 mg/kg); stone fruit (0.2 mg/kg); edible offal (mammalian) (*0.01 mg/kg); eggs (*0.01 mg/kg); meat (mammalian) [in the fat] (*0.01 mg/kg); milks (*0.01 mg/kg); milk fats (*0.01 mg/kg); poultry, edible offal of (*0.01 mg/kg); and poultry meat [in the fat] (*0.01 mg/kg). The recommended WHPs for Delegate Insecticide are stated on the draft label. The following grazing restraint is also applicable: “DO NOT GRAZE ANY TREATED AREA OR CUT FOR STOCKFOOD”.

(iii) The APVMA is satisfied that the proposed use of the new product DELEGATE Insecticide containing the new active constituent, spinetoram, would not be likely to have an unintended effect that is harmful to animals, plants or things or the environment.

The Department of the Environment, Heritage, Water and the Arts has assessed data in support of the proposed use and has concluded that the risks to the environment from this use are acceptable.

Spinetoram preferentially partitions to sediment but rapidly degrades in water via photodegradation, and is not expected to reach sediment in natural environments. On soil, degradation is also rapid and occurs via photolysis and metabolism. Spinetoram is not expected to persist in water or soil between spray applications, and has low mobility in soil. However, spinetoram is more persistent on foliage and some additive effects from multiple applications may be expected.

Spinetoram is not expected to be toxic to birds and to have a low to moderate toxicity to fish. Spinetoram is highly toxic to some aquatic invertebrates and algae, and consistent with its insecticidal nature, is highly toxic to some terrestrial invertebrates. Terrestrial plants and soil microorganisms were generally insensitive to spinetoram.

The risk to aquatic species is acceptable based on the results of spray drift modelling, with no buffers required for ground applications on environmental grounds. There is likely to be acceptable risk to terrestrial invertebrates from the proposed ground application provided there is compliance with amendments of the label to specify the dangers to bees and to beneficial insects in Integrated Pest Management (IPM) orchards.

The APVMA has considered the findings of the Department of the Environment, Water, Heritage and the Arts and accepts their recommendations on this criterion.

(iv) The APVMA advises that use of the product in accordance with the required

instructions could potentially unduly prejudice trade and commerce between Australia and places outside of Australia as per section 14(3)(e)(iv) of the AgVet Codes. Pome fruit and stone fruit are exported and detectable residues are expected to occur above the standards of key export markets.

The following trade advice is on the label: “CAUTION: Delegate Insecticide may leave detectable chemical residues in harvested produce. Overseas markets may not have appropriate residue tolerances in place or may have established tolerances which are lower than Australian maximum residue limits. Some crops for export to these destinations may require a longer harvesting withholding period. If you are using this product on crops destined for export, please contact your exporter for advice.” The likelihood of detectable residues occurring in livestock and poultry commodities as a result of animal exposure to dry apple pomace from treated crops is considered small. Accordingly, the use of Delegate Insecticide on pome fruit and stone fruit is not expected to unduly prejudice Australian trade in livestock and poultry commodities. A determination of undue prejudice to trade or commerce should be made following the completion of the trade consultation process. Any areas of concern and possible management strategies have been outlined in the Public Release Summary

In relation to its assessment of efficacy under section 14(3)(f), the APVMA proposes to determine that:

(v) The APVMA is satisfied the data from trials supporting the efficacy of DELEGATE

INSECTICIDE adequately demonstrates that under local conditions this product is effective for the proposed uses.

Public Release Summary A Public Release Summary of the evaluation is available on the APVMA website www.apvma.gov.au or by contacting Colin McCormack on telephone (02) 6210 4709. Written submissions on the APVMA’s proposal to grant the application for registration should be addressed in writing to: Pat Robinson Pesticides Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4756 Fax: (02) 6210 4776

http://www.apvma.gov.au/

NOTICE

[Clorsulon, Ivermectin and Nitroxynil]

[in the product: Virbac Nitromec Injection Endectocide and Flukicide for Cattle] The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Virbac (Australia) Pty Limited to register a new combination product, Virbac Nitromec Injection Endectocide and Flukicide for Cattle, (‘the product’) which contains the currently approved actives clorsulon (67 mg/mL), ivermectin (6.7 mg/mL) and nitroxynil (340 mg/mL). The new product is to be administered by subcutaneous injection to beef cattle and non-lactating (dry) dairy cattle, for the treatment and control of sensitive strains of internal and external parasites, including early immature, immature and adult liver fluke. The application involves the establishment of an Australian Maximum Residue Limit (MRL) for nitroxynil in cattle milk. Additionally, the application requires the setting of meat and milk withholding periods (WHPs), establishment of an export slaughter interval (ESI), and approval of the proposed product label. The APVMA invites any person to submit a relevant written submission as to whether the application to register the use of this product in beef cattle and non-lactating (dry) dairy cattle should be granted. Such submissions should detail comments stating the grounds on which the submission is based. Such grounds should relate only to the trade implications associated with use of the product. Comments must be received by the APVMA within 28 days of the date of this notice. Particulars of Application Product Name: VIRBAC NITROMEC INJECTION

ENDECTOCIDE AND FLUKICIDE FOR CATTLE

Applicant Company: Virbac (Australia) Pty Limited] Active Constituents: Clorsulon (67 mg/mL), ivermectin (6.7

mg/mL) and nitroxynil (340 mg/mL) Signal Heading: Schedule 6 Statement of Claim: For the treatment and control of roundworms,

liver fluke, lice and ticks in cattle. Pack Sizes: 500mL, 1L, 2.5L Proposed MRLs: 0.5 mg/kg for nitroxynil in milk Withholding Periods (WHPs): MEAT: DO NOT USE less than 56 days before

slaughter for human consumption. Calves born to cows that have been treated with Virbac Nitromec Injection Endectocide and Flukicide for Cattle during pregnancy must not be slaughtered for human consumption for 56 days after treatment of the dam.

MILK: DO NOT USE in lactating cows or within 30 days of calving. For 84 hours (7 milkings) after calving, all colostrum and milk collected from treated cows MUST BE DISCARDED, and not be used or processed for human consumption or fed to calves. If cows calve earlier than 30 days after treatment, consult your veterinarian for advice on the milk discard period.

Export Slaughter Interval (ESI): DO NOT USE less than 120 days (4 months) before slaughter for export. Calves born to cows that were treated with Virbac Nitromec Injection Endectocide and Flukicide for Cattle during pregnancy must not be slaughtered for export for 120 days (4 months) after treatment of the dam.

Summary of the APVMA’s assessment of the application in accordance with section 14(3)(e) of the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 The APVMA has evaluated the application and in its assessment in relation to human and environmental safety under section 14(3)(e) of the Agvet Code, it proposes to determine that: (i) The APVMA is satisfied that the use of this product would not present an undue

hazard to the safety of people consuming produce from animals treated with this product.

(ii) The APVMA has completed an evaluation of the data and has supported the proposed MRLs and Withholding Periods for this product and use patterns.

Residues Evaluation The APVMA has evaluated the residues aspects of the product.

Meat: When the recommended 56 day meat WHP is observed, the concentrations of nitroxynil residues in all edible bovine tissues (liver, kidney, muscle, peri-renal fat and injection site tissues) comply with the existing Australian nitroxynil MRLs. Similarly, residues of ivermectin and clorsulon in all edible tissues from treated cattle comply with the relevant Australian MRLs.

Milk: When the 30 day treatment-to-calving interval and milk WHP of 84 hours (7 milkings) are observed, clorsulon residues in milk are non-detectable (<0.02 mg/kg) and comply with the existing Australian MRL of 1.5 mg/kg for clorsulon in milk. Similarly, ivermectin residues in milk are below 0.005 mg/kg, which is below the existing Australian MRL of 0.05 mg/kg for ivermectin in milk.

To date, there is no Australian MRL for nitroxynil residues in milk. The data provided in support of the current application show that nitroxynil residues in milk are below 0.5 mg/kg when the milk WHP of 84 hours (7 milkings) is observed. These data support the establishment of a milk MRL of 0.5 mg/kg for nitroxynil.

Trade Evaluation The APVMA has also evaluated the residues in trade aspects of the product.

Meat: When the recommended ESI of 120 days (4 months) is observed, the concentrations of nitroxynil, ivermectin and clorsulon residues in all edible bovine tissues (liver, kidney, muscle, peri-renal fat and injection site tissues) are expected to be below the relevant method LOQs for each analyte. Therefore, the risk to Australia’s export trade in beef/veal and live cattle, arising from the use of the product is considered to be low when the recommended ESI of 120 days (4 months) is observed.

Milk: The use of the product in non-lactating (dry) dairy cows, with a 30 day treatment-to-calving interval and milk WHP of 84 hours (7 milkings), results in detectable levels of nitroxynil in milk. [Clorsulon residues in milk are non-detectable (<0.02 mg/kg). Ivermectin residues in milk are below 0.005 mg/kg, which is below the relevant Codex CXL of 0.01 mg/kg.]

Nitroxynil has not been considered by Codex. Further, there are no overseas MRLs or import tolerances for nitroxynil residues in milk. Therefore, use of the new combination product in non-lactating (dry) dairy cows has the potential to unduly prejudice Australia’s export trade in dairy commodities, due to the presence of nitroxynil residues in milk.

Accordingly, the APVMA invites comment from industry groups and stakeholders in relation to the perceived level of risk to Australia’s export trade in dairy commodities, and whether there are industry-based strategies available to manage the identified trade risks.

A Trade Advice Notice (TAN) has been circulated to industry peak bodies to allow comment on the trade aspects of the application prior to the determination of the application. Copies of the TAN are available on request or from the website www.apvma.gov.au Other Criteria During the evaluation of this application, the APVMA addressed and is satisfied of the following criteria for registration: Chemistry and Manufacture Toxicology Occupational Health and Safety Environmental Safety Target Species Efficacy and Safety Submissions Submissions relating to the trade implications of the proposal to grant this application for variation of registration should be addressed in writing to: Dr Judith Platt Veterinary Medicines Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4735 Fax: (02) 6210 4741 Email: [email protected]

Addendum list of Approved

ACTIVE CONSTITUENTS

The current Record of Approved Active Constituents is also accessible via the APVMA web page on: http://www.apvma.gov.au/actives/downloads/aa_AK.pdf and http://www.apvma.gov.au/actives/downloads/aa_LZ.pdf

Approved since Gazette No. 6, 1st December 2007

For Use in Agricultural Chemical Products:

METHAM POTASSIUM MANUFACTURING CONCENTRATE

IMTRADE AUSTRALIA PTY LTD

TAMINCO NV 207 PANTSERSCHIP STR B-9000 GHENT BELGIUM

60794

DELTAMETHRIN FORWARD AUSTRALIA PTY LTD

TAGROS CHEMICALS INDIA LIMITED A 4/1, SIPCOT INDUSTRIAL COMPLEX PACHAYANKUPPAM CUDDALORE 607005 INDIA

62142

PRODIAMINE SYNGENTA CROP PROTECTION PTY LIMITED

ELGIN FINE CHEMICALS INC 2114 LARRY ROAD ELGIN SOUTH CAROLINA USA

63027

OXYFLUORFEN GENFARM CROP PROTECTION PTY LTD

JIANGSU AGROCHEM LABORATORY CO LTD 98 MINJIANG RD HI-TECH DEVELOPMENT ZONE CHANGZHOU JIANGSU 213022 PR CHINA

62858

BRODIFACOUM 4 FARMERS PTY LTD NANJING ZHICHENG CHEMICAL CO LTD LAIYINDA ROAD, JIANGNING ECONOMIC DEVELOPMENT AREA, NANKING, JIANGSU CHINA

62292

TERBUTHYLAZINE AGROGILL CHEMICALS PTY LTD

MEGHMANI INDUSTRIES LIMITED BLOCK NO 401, VILLAGE CHHARODI TALUKA SANAND, DISTRICT AHMEDABAD STATE GUJARAT 382 170 INDIA

62651

FLUTRIAFOL OSPRAY PTY LTD CHEMINOVA AGRO A/S THYBORONVEJ 76-78 DK-7673 HARBOORE DENMARK

62658

For enquiries please contact: Chemistry & Residues Pesticides Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: 02 6210 4818 Fax: 02 6210 4840 Email: [email protected]

NOTICE

Application Summaries

The APVMA publishes complete application summaries on the APVMA website (http://www.apvma.gov.au/data_protection/appl_summaries.shtml). They are published in weekly instalments using the date the application was accepted for assessment. If an application summary has been amended, the APVMA will publish the amended version on the website and list it separately in the APVMA Gazette Notice for Application Summaries. As a requirement of Regulations 8C and E of the Agvet Code, some product names will appear as 'NOT AVAILABLE'. A summary will be removed from the website 28 days after the application has been finalised. Therefore, some summaries published in this notice may have already been removed prior to the Gazette being published. Application summaries published since those published in APVMA Gazette No. 7, 1st July 2008.

Application No. Name

41739 MORTEIN ULTRA KILL ALL INSECT KILLER HOUSEHOLD PROTECTION 42325 OSPRAY TRIBENURON-METHYL 750 WG HERBICIDE 42350 BIOGUARD SPA PURITY OXIDISER 42411 HOMETEAM ECO-BOR TIMBER PRESERVATIVE & FUNGICIDE 42665 4 FARMERS POTASSIUM GLYPHOSATE 500 HERBICIDE 42773 TRIFERT TOMATO FLOWER SET GROWTH REGULANT 42796 IMAZALIL SULFATE 42808 PROCARE TIK BOS POUR-ON TICK DEVELOPMENT INHIBITOR 42810 TALSTAR 3ME INSECTICIDE/MITICIDE 42825 TALSTAR 3ME INSECTICIDE/MITICIDE 42898 4FARMERS IMIDACLOPRID 600 SC INSECTICIDE 43006 TELCHEM CHLOR 100 100% SOLUBLE STABILISED CHLORINE

43008 TELCHEM SALT-SHOCK 100% SOLUBLE STABILISED CHLORINE ALGAECIDE-BACTERCIDE

43030 NOT AVAILABLE 43061 BIOPROTON PHYTASE 43106 ULTIMATE BRUSHWEED HERBICIDE 43256 EXODUS PLUS SELENIUM MOXIDECTIN DRENCH FOR SHEEP 43281 ISOMATE C-S PHEROMONE INSECT CONFUSION AGENT 43335 NOT AVAILABLE 43759 NOT AVAILABLE 43791 NOT AVAILABLE 43821 KONDEMN HERBICIDE ADJUVANT 43840 RIDDLER HERBICIDE 43936 FARMOZ URAGAN WG HERBICIDE 44003 NOT AVAILABLE 44103 NETVAX VACCINE FOR POULTRY 44109 NOT AVAILABLE 44110 SUMMIT ECOPAR 20 SC HERBICIDE 44139 COMPONENT S WITH TYLAN GROWTH AND FINISHING IMPLANTS FOR STEERS 44143 NOT AVAILABLE 44177 NOT AVAILABLE 44210 AQUA PURE POOL ALGAECIDE 44229 PURE BLUE LOW RESIDUE GRANULAR POOL CHLORINE 44239 PURE BLUE POOL ALGAECIDE

44514 WORKS ON ALL LAWNS INCLUDING BUFFALO ADVANCED YATES DOUBLE ACTION LIQUID WEED'N'FEED

44529 SOCCER 750 WG HERBICIDE 44531 NOT AVAILABLE 44602 NOT AVAILABLE 44634 ATRAZINE 44655 SUMITOMO SAMURAI SYSTEMIC INSECTICIDE 44680 OZCROP PARAQUAT 250 HERBICIDE 44682 NOT AVAILABLE 44746 HOVEX 2 IN 1 OUTDOOR & INDOOR SURFACE SPRAY 44748 HOVEX HOME PROTECTION 2 IN 1 OUTDOOR & INDOOR SURFACE SPRAY 44777 MEDALLION-G GRANULAR INSECT BAIT 44816 AW BROMO 200 HERBICIDE 44835 WILCHEM SPRAY GRADE AMMONIUM SULFATE HERBICIDE ADJUVANT 44835 WILCHEM SPRAY GRADE AMMONIUM SULFATE HERBICIDE ADJUVANT 44844 ECO - NEEM BOTANICAL INSECTICIDE 44865 COUNTRY BIFENTHRIN AQUA TURF INSECTICIDE 44875 MANCOZEB MANUFACTURING CONCENTRATE 44876 MANCOZEB MANUFACTURING CONCENTRATE 44922 COUNTRY CARBENDAZIM 500 FUNGICIDE 44952 NOT AVAILABLE 44979 OSPRAY TROJAN INSECTICIDE 44985 YATES ROSE SHIELD BLACK SPOT AND INSECT PEST KILLER 44985 YATES ROSE SHIELD BLACK SPOT AND INSECT PEST KILLER 45006 NOT AVAILABLE 45012 NOT AVAILABLE 45025 COUNTRY MEPIQUAT 38 COTTON GROWTH REGULATOR 45026 COUNTRY CHLOROTHALONIL 720 FUNGICIDE 45027 COUNTRY FLUTRIAFOL 25/CYPERMETHRIN 4 LIQUID SEED DRESSING 45047 NOT AVAILABLE 45068 SURIA 500 HERBICIDE 45082 NOT AVAILABLE 45097 CHOICE HEXAZINONE 250 HERBICIDE 45104 TITAN IMIDACLOPRID 200 INSECTICIDE 45109 NOT AVAILABLE 45156 MYCOFIX PLUS 3.0 45178 AW MUZZLE HERBICIDE 45179 AW HARPOON 520 HERBICIDE 45181 AW CLASH 300 HERBICIDE 45201 GENFARM 2,4-D AMINE 625 HERBICIDE 45203 AW STOUSH 900 WG HERBICIDE 45205 UNI-SPRAY 250 HERBICIDE 45275 NOT AVAILABLE 45276 NOT AVAILABLE

A change or correction has been made to the following summaries: Application No. Product/Active Constituent Name

39732 SLIMEBUSTER: THE POWER PELLET SNAIL AND SLUG BAIT 42602 RADIX FLOWABLE SEED DRESSING

Contact: Application Management and Enquiries Unit (AME) Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604

Ph: 6210 4701 Fax: 6210 4721

_____________________________________________________________________________________________________________ * Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer

NOTICE

Licensing of Veterinary Chemical Manufacturers _________________________________________________________________________ Pursuant to Part 8 of the Agricultural and Veterinary Chemical Codes scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has issued, amended or cancelled the manufacturing licences in respect of the following veterinary chemical manufacturers, with effect from the dates shown. For a comprehensive listing of all licensed manufacturers please see the APVMA’s web site: http://www.apvma.gov.au. _________________________________________________________________________ 1. NEW LICENCES: ANNEX HOLDINGS PTY LTDACN: 080 349 828 114 Fairbank Road CLAYTON SOUTH VIC 3169

Product Types:* Category 6: Single Step Step(s) of Manufacture: Secondary packaging, secondary labelling, repackaging, relabelling, storage. Licence No: 6141 Full licence issued 26/06/08, with special conditions.

2. CHANGES TO EXISTING LICENCES: AGRISEARCH ANALYTICAL PTY LIMITED ACN: 094 752 959 Level 1, 48 Victoria Road ROZELLE NSW 2039

Product Types:* Category 6: Single Step Step(s) of Manufacture: Analysis and testing (chemical) Licence No: 6106 Amended licence issued 26/06/08, change of key personnel.

BETTER SACHETS PTY LTD ACN: 003 441 441 Units 5 & 6 17 King Road HORNSBY NSW 2077

Product Types:* Category 6: Single Step Step(s) of Manufacture: Strip, blister or sachet packaging, large hard gelatine capsule filling, and labelling Licence No: 6081 Amended licence issued 06/06/08, variation to conditions, change of key personnel, correction of address.

DELTA LABORATORIES PTY LTD ACN: 050 324 742 8 Warringah Close SOMERSBY NSW 2250

Product Types:* Category 1: Sterile products Category 2: Creams, lotions, ointments, pastes, sprays, liquids. Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, aseptic filling, packaging, labelling, sterilisation (heat and filtration), analysis and testing (physical, chemical and microbiological), storage, and release for supply Licence No: 1056 Amended licence issued 30/06/08, variation to conditions, extension to licence scope, change of key personnel.

FELTON GRIMWADE & BOSISTO’S PTY LTD ACN: 004 809 161 61-69 Clarinda Road OAKLEIGH SOUTH VIC 3167

Product Types:* Category 2: Liquids (eucalyptus oil and eucalyptus oil based products and other liquid preparations) Step(s) of Manufacture: Formulation including blending, filling, packaging, labelling, analysis and testing (physical and chemical), storage and release for supply. Licence No: 2053 Amended licence issued 23/06/08, change of key personnel, change to company name.

INSTITUTE OF MEDICAL & VETERINARY SCIENCE ABN: 35 302 506 443 Veterinary Services Division 101 Blacks Road GILLIS PLAINS SA 5086

Product Types:* Category 6: Single Step Step(s) of Manufacture: Analysis and testing (serological, immunobiological) Licence No: 6132 Amended licence issued 12/06/08


MARS AUSTRALIA PTY LTD Trading as MARS PETCARE AUSTRALIA ACN: 008 454 313 Petcare Place WODONGA VIC 3690

Product Types:* Category 2: Palatable ingestable chews. Category 4: Moist therapeutic pet foods. Step(s) of Manufacture: Quality Assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, strip, blister or sachet packaging, microbial reduction treatment (heat), analysis and testing (physical, chemical and microbiological), storage and release for supply. Licence No: 2106 Amended licence issued 26/06/08, change of key personnel.

MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED ACN: 106 340 667 Factory 7,8 & 10 56 Smith Road SPRINGVALE VIC 3171

Product Types:* Category 2: Liquids (Methoxyflurane only) Step(s) of Manufacture: Quality Assurance (QA) of raw materials, chemical synthesis, filling, packaging, labelling, storage and release for supply. Licence No: 2196 Amended licence issued 26/06/08, change to key personnel.

PHEBRA PTY LTD ACN: 059 357 890 332 Burns Bay Road LANE COVE NSW 2066

Product Types:* Category 1: Sterile Products (liquids) Category 2: Liquids Step(s) of Manufacture: Formulation including blending, filling, packaging, labelling, strip, blister or sachet packaging, microbiological reduction treatment (heat), storage and release for supply. Licence No: 1062 Amended licence issued 26/06/08, change of company name.

QEA AUSTRALIA PTY LIMITED ACN: 114 603 968 Unit 4/ 127 Magowar Road GIRRAWEEN NSW 2145

Product Types:* Category 6: Single Step Step(s) of Manufacture: Quality assurance (QA) of raw materials, secondary/supplementary labelling, storage and release for supply. Licence No: 6116 Amended licence issued 28/05/08, change to format.


RIDLEY AGRIPRODUCTS PTY LTD ACN: 006 544 145 1325 Boundary Road WACOL QLD 4076

Product Types:* Category 4: Supplements Step(s) of Manufacture: Quality Assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, tableting, storage and release for supply. Licence No: 4011 Amended licence issued 27/06/08, change to key personnel.

RUDDUCKS PTY LTD ABN: 6000 4666 871 894-906 Taylors Rd LYDHURST VIC 3975

Product Types:* Category 2: Pastes, powders, sprays and liquids. Category 3: Liquids, pastes, sprays and powders. Step(s) of Manufacture: Quality Assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, analysis and testing (physical), storage and release for supply Licence No: 2192 Amended licence issued 26/06/08, change of key personnel.

SPHERE HEALTHCARE PTY LIMITED ACN: 054 309 705 10-12 Church Street MOOREBANK NSW 2170

Product Types:* Category 2: Tablets, pellets, capsules, capsules (soft gelatine), creams/lotions, ointments, pastes, powders, liquids and suspensions Category 4: Premixes, supplements and probiotics Step(s) of Manufacture: Quality Assurance (QA) of raw materials, formulation including blending, dry milling of powders, wet milling of powders, granulation, filling, packaging, labelling, strip, blister or sachet packaging, soft gelatine capsule manufacture, tableting, tablet coating, capsule filling from bulk, analysis and testing (physical, chemical), storage and release for supply. Licence No: 2187 Amended licence issued 26/06/08, change to key personnel.


THE PHARMACEUTICAL PLANT COMPANY PTY. LTD. ACN: 058 801 355 2/24 London Drive BAYSWATER NORTH VIC 3153

Product Types:* Category 2: Creams (herbal), ointments (herbal), pastes (herbal), powders (herbal), sprays (herbal) and liquids (herbal). Category 4: Premixes (herbal) and supplements (herbal) Step(s) of Manufacture: Formulation including blending, filling, packaging, labelling, strip, blister or sachet packaging, sterilisation (filtration), microbiological reduction treatment (filtration), analysis and testing (physical, chemical, pharmalogical and microbiological), storage and release for supply. Licence No: 2157 Amended licence issued 26/06/08, change to key personnel.

TRIPAK PHARMACEUTICALS PTY LTD ACN: 010 856 569 22 Neumann Road CAPALABA QLD 4157

Product Types:* Category 6: Single Step Step(s) of Manufacture: Filling, packaging and labelling Licence No: 6080 Amended licence issued 13/06/08, change to company name

3. LICENCE CANCELLATIONS: (The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’]). AMDEL LIMITED ACN: 008 127 802 Unit 1/21 Smallwood Place MURARRIE QLD 4172

Licence No: 6095 Cancelled: 17/06/08 Reason for cancellation: s127 (1)(d),(e) and (f)

AMS LABORATORIES PTY LIMITED ACN: 075 467 757 118 Hattersley Street ROCKDALE NSW 2216

Licence No: 6057 Cancelled: 18/06/08 Reason for cancellation: s127 (1)(d)

CONSULCHEM PTY LTD ACN: 005 377 613 Unit 1-2, 7-11 Rocco Drive SCORESBY VIC 3179

Licence No: 6051 Cancelled: 17/06/08 Reason for cancellation: s127 (1)(d),(e) and (f)


DIFA CHEMICAL INDUSTRIES PTY LTD ACN: 010 679 955 3507 Pacific Highway SLACKS CREEK QLD 4127

Licence No: 3011 Cancelled: 28/08/07 Reason for cancellation: s127 (1)(d)

4. LICENCE SUSPENSIONS: (The APVMA has suspended the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’]). NIL

5. REVOCATION OF LICENCE CANCELLATION: (The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’]). NIL

6. REVOCATION OF LICENCE SUSPENSION: (The APVMA has revoked the suspension of the following licences under subsection 127(7) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’]). NIL

APVMA Contact: Kathryn Winterton GMP Section Veterinary Medicines Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Ph: (02) 6210 4804 Fax: (02) 6210 4813 Email: [email protected]


mailto:[email protected]

Notice Under Section 101 of the Agvet Codes

No.0007 of 2008

“Recall” of Unregistered Agricultural Chemical Products

On 14 July 2008 the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a Notice to Christos Costi (“the supplier”) pursuant to Section 101 of the Agvet Codes, in relation to the following products:

Garden Spray; manufactured and labeled by Christos Costi; Batches: All Insect Spray; manufactured and labeled by Christos Costi; Batches: All

The Notice requires the supplier to recall all stocks of the product in the possession of End Users, to stop supply and quarantine any stocks of the product the supplier holds or is returned as result of the recall. The supplier must report to the APVMA in regard to the actions taken to give effect to the recall. The products are agricultural chemical products and the APVMA has not registered the products under the Agvet Code. Supplier Details Christos Costi 17 Scott Street WEST END BRISBANE QLD, 4101 This matter is published in accordance with section 104 of the Agvet Codes. For further information about this matter, please contact: Drew Ward A/g Senior Compliance Analyst Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: 02 6210 4800 Email: [email protected]

mailto:[email protected]

AMENDMENT No. 1L

AMENDMENTS TO THE MRL STANDARD

The Australian Pesticides and Veterinary Medicines Authority (APVMA) sets maximum residue limits (MRLs) of agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. These 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. At the same time the APVMA is satisfied, from dietary exposure assessment, that the levels are not an undue hazard to human health. The MRL Standard lists MRLs of substances which may arise from the approved use of those substances or other substances, and provides the relevant residue definitions to which these MRLs apply. The evaluation process takes into account studies on chemistry, metabolism, analytical methodology, residues, good agricultural practice, toxicology and dietary exposure. From time to time the evaluation process results in amendments to the MRL Standard. It should be noted that relevant MRLs are referred to Food Standards Australia New Zealand for incorporation into Standard 1.4.2 of the Food Standards Code entitled “Maximum Residue Limits”. Note: ‘*’ denotes that the maximum residue limit (MRL) has been set at or about the limit

of analytical quantitation (see: Residue Guideline No.4, Maximum Residue Limit Proposals ‘At or about the Limit of Analytical Quantitation’, published in NRA Gazette No.9, p44, 5/9/95).

‘T’ denotes that the MRL, residue definition or use is temporary to enable further

experimental work to be carried out in Australia or overseas, and will be reconsidered at some future date.

The MRL Standard is also accessible via the APVMA web page. http://www.apvma.gov.au/residues/mrl.shtml

http://www.apvma.gov.au/residues/mrl.shtml

TABLE 1: MAXIMUM RESIDUE LIMITS OF PESTICIDES,

AGRICULTURAL CHEMICALS, FEED ADDITIVES, VETERINARY MEDICINES AND ASSOCIATED SUBSTANCES IN FOOD COMMODITIES

Residues of substances which may occur in food commodities and for which the following maximum residue limits (MRLs) apply. COMPOUND FOOD MRL (mg/kg) Bifenazate ADD:

VC 0424 Cucumber T0.5 VO 0445 Peppers, Sweet T2 VO 0448 Tomato T0.5

Bifenthrin DELETE: VO 0440 Egg plant T0.5 VO 0442 Okra T0.5

VO 0051 Peppers 0.5 VO 0448 Tomato 0.5

ADD: VO 0050 Fruiting vegetables, other than

Cucurbits 0.5

Flubendiamide ADD:

VB 0040 Brassica (cole or cabbage) vegetables, Head cabbages, Flowerhead brassicas T3 VL 0482 Lettuce, Head T5 VL 0483 Lettuce, Leaf T5 VO 0447 Sweet corn (corn-on-the-cob) T*0.05

Methomyl ADD: VR 0494 Radish T1

VA 0389 Spring onion 1 VR 0497 Swede T1 VR 0506 Turnip, Garden T1

Pymetrozine DELETE: TN 0660 Almonds T*0.02 ADD:

TN 0660 Almonds T*0.01

ADD: Pyroxsulam

MO 0105 Edible offal (Mammalian) *0.01 PE 0112 Eggs *0.01 MM 0095 Meat [mammalian] *0.01 ML 0106 Milks *0.01 PO 0111 Poultry, Edible offal of *0.01 PM 0110 Poultry meat *0.01 GC 0654 Wheat *0.01

TABLE 3: RESIDUE DEFINITION Where MRL(s) are recommended, the following residue definitions are applicable. COMPOUND RESIDUE DELETE: Propachlor Propachlor ADD: Propachlor Sum of propachlor and metabolites hydrolysable to N-isopropylaniline, expressed as propachlor

ADD: Pyroxsulam Pyroxsulam

TABLE 4: MAXIMUM RESIDUE LIMITS FOR PESTICIDES IN ANIMAL FEED

COMMODITIES Residues of substances which may occur in animal feed commodities and for which the following maximum residue limits (MRLs) apply. COMPOUND ANIMAL FEED COMMODITY MRL (mg/kg) Pymetrozine ADD: Almond Hulls T0.05 ADD: Pyroxsulam

AS 0654 Wheat straw and fodder, dry 0.1 Wheat forage, dry 0.1

For further information please contact: Michelle Hemming Residues Contact Officer Australian Pesticides & Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4837 Fax: (02) 6210 4840 Email: [email protected]

AMENDMENT No. 2L

AMENDMENTS TO THE MRL STANDARD

The Australian Pesticides and Veterinary Medicines Authority (APVMA) sets maximum residue limits (MRLs) of agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. These 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. At the same time the APVMA is satisfied, from dietary exposure assessment, that the levels are not an undue hazard to human health. The MRL Standard lists MRLs of substances which may arise from the approved use of those substances or other substances, and provides the relevant residue definitions to which these MRLs apply. The evaluation process takes into account studies on chemistry, metabolism, analytical methodology, residues, good agricultural practice, toxicology and dietary exposure. From time to time the evaluation process results in amendments to the MRL Standard. It should be noted that relevant MRLs are referred to Food Standards Australia New Zealand for incorporation into Standard 1.4.2 of the Food Standards Code entitled “Maximum Residue Limits”. Note: ‘*’ denotes that the maximum residue limit (MRL) has been set at or about the limit

of analytical quantitation (see: Residue Guideline No.4, Maximum Residue Limit Proposals ‘At or about the Limit of Analytical Quantitation’, published in NRA Gazette No.9, p44, 5/9/95).

‘T’ denotes that the MRL, residue definition or use is temporary to enable further

experimental work to be carried out in Australia or overseas, and will be reconsidered at some future date.

The MRL Standard is also accessible via the APVMA web page. http://www.apvma.gov.au/residues/mrl.shtml

http://www.apvma.gov.au/residues/mrl.shtml

TABLE 1: MAXIMUM RESIDUE LIMITS OF PESTICIDES,

AGRICULTURAL CHEMICALS, FEED ADDITIVES, VETERINARY MEDICINES AND ASSOCIATED SUBSTANCES IN FOOD COMMODITIES

Residues of substances which may occur in food commodities and for which the following maximum residue limits (MRLs) apply. COMPOUND FOOD MRL (mg/kg) Dithiocarbamates (mancozeb, metham, metiram, propineb, thiram, zineb and ziram) DELETE:

FI 0343 Litchi T5

ADD: FI 0343 Litchi 5

Indoxacarb DELETE:

FB 0275 Strawberry T1 ADD:

FB 0018 Berries and other small fruits (excluding grapes) T1

TABLE 5: USES OF SUBSTANCES WHERE MAXIMUM RESIDUE

LIMITS ARE NOT NECESSARY SUBSTANCE USE DELETE: Canola Oil

- As a miticide/insecticide in home gardens, ornamentals floriculture, and vegetable crops grown in protected environments

ADD: Canola Oil

- As a miticide/insecticide in home gardens, ornamentals floriculture, and vegetable and fruits

DELETE: Potassium linoleate

- Insecticide on fruit, vegetables and cotton DELETE: Potassium oleate

- Insecticide on fruit, vegetables and cotton DELETE: Potassium palmitate

- Insecticide on fruit, vegetables and cotton DELETE: Potassium stearate

- Insecticide on fruit, vegetables and cotton ADD: Potassium salts of fatty acids

- Fungicide on grapevines - Insecticide on fruit, vegetables and cotton

For further information please contact: Michelle Hemming Residues Contact Officer Australian Pesticides & Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4837 Fax: (02) 6210 4840 Email: [email protected]

TABLE OF CONTENTS · 2014-09-30 · TABLE OF CONTENTS Notice of ... Clorsulon, Ivermectin and...

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