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TABLE OF CONTENTS

Notice of Registrations Agricultural Chemical Products Page 4 Veterinary Chemical Products 1 Notice – New Agricultural & Veterinary Chemical Products florasulam [in the product: TORPEDO HERBICIDE] Page 14 Other Notices Reconsideration of Registrations of Products Which Contain Neomycin Page 18 and their Associated Approved Labels Licensing of Veterinary Chemical Manufacturers Page 21 Application Summaries Page 26 Amendments to the MRL Standard Page 29 Addendum List of Approved Active Constituents Page 33

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: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Label Approval No: “ No entries” 3. AGRICULTURAL PRODUCTS

BASED ON EXISTING ACTIVE CONSTITUENTS:

Product Name: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Label Approval No: Product Name: Scotts Lawnbuilder + Grub & Insect Control Active Constituent/s: 0.86 g/kg bifenthrin Applicant Name: Scotts Australia Pty Ltd Applicant ACN: 003 123 162

Summary of Use: A slow release fertiliser with bifenthrin product to control lawn grubs and other insect pests in the home garden. Date of Registration: 5 December 2006 Label Approval No: 57766/2.5/0206 Product Name: Mortein High Performance Cockroach Killer Active Constituent/s: 0.30 g/kg imiprothrin, 1.5 g/kg cypermethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: Controls insects in the home including cockroaches, spiders, ants, carpet beetles, fleas, clothes moths, silverfish, millipedes and bed bugs. Date of Registration: 5 December 2006 Label Approval No: 58716/250g/0906, 58716/350g/0906 Product Name: Coles Reliance Pool Chlorine Granular Active Constituent/s: 650 g/kg chlorine (Cl) present as calcium hypochlorite. Applicant Name: Hy-Clor (Australia) Pty Ltd Applicant ACN: 000 655 381 Summary of Use: For the control of algae and bacteria in swimming pools. Date of Registration: 5 December 2006 Label Approval No: 61342/2/0906, 61342/4/0906, 61342/10/0906 Product Name: Searles Rose Pro Bsmartlack Spot & Insect Killer Active Constituent/s: 0.10g/L tau-fluvalinate, .05g/L myclobutanil. Applicant Name: J C & A T Searle Pty Ltd Applicant ACN: 002 898 893 Summary of Use: For the control of insect pests and diseases of roses and other ornamentals in the home garden. Date of Registration: 6 December 2006 Label Approval No: 61489/1/1106 Product Name: Genfarm Clopyralid 300 SC Herbicide Active Constituent/s: 300 g/L clopyralid present as the triisopropanolamine salt Applicant Name: Genfarm Crop Protection Pty Ltd Applicant ACN: 115 327 378 Summary of Use: For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures, fallow land, forests and industrial situations. Date of Registration: 6 December 2006 Label Approval No: 61344/20L/0906, 61344/0906

Product Name: Mortein Dettol With Germ Stop Cockroach Killer Household Protection Active Constituent/s: 0.70 g/kg imiprothrin, 1 g/kg alkyl dimethyl benzyl ammonium saccharinate, 2 g/kg cypermethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: A ready-to-use aerosol that provides protection against crawling insects and spiders in the home. Date of Registration: 6 December 2006 Label Approval No: 60629/200g/0706, 60629/300g/0706 Product Name: Fresh Is Best Pools Copper / Silver Rods Active Constituent/s: 90 g/kg silver (as the metal), 910 g/kg copper (as the metal). Applicant Name: Fresh Poolwater Pty Ltd Applicant ACN: 103 344 869 Summary of Use: For control of algae in swimming pools and spas. Date of Registration: 6 December 2006 Label Approval No: 61361/01/0906 Product Name: Smart Glyphosate 450 Herbicide Active Constituent/s: 450 g/L glyphosate. Applicant Name: Crop Smart Pty Ltd Applicant ACN: 093 927 961 Summary of Use: For the non-selective control of many annual and perennial weeds in a range of situations. Date of Registration: 11 December 2006 Label Approval No: 60952/20-1000L/1106, 60952/1106 Product Name: Gladiator Maximus Herbicide Active Constituent/s: 510 g/L glyphosate present as the isopropylamine salt Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Use: A non-selective water soluble herbicide for the control of a wide range of annual and perennial weeds in a wide variety of situations. Date of Registration: 12 December 2006 Label Approval No: 61448/20L/1206, 61448/110L/1206, 61448/1000L/1206, 61448/1206 Product Name: Kills Up To 6 Months Select Woolworths High Performance Surface Spray Active Constituent/s: 0.7 g/kg imiprothrin, 2 g/kg cypermethrin Applicant Name: Woolworths Ltd Applicant ACN: 000 014 675 Summary of Use: Insect surface spray to kill

crawling insects for up to six months. Date of Registration: 12 December 2006 Label Approval No: 61346/350g/1006 Product Name: Farmoz Cotnion Insecticide Active Constituent/s: 200 g/L azinphos-methyl Applicant Name: Farmoz Pty Limited Applicant ACN: 050 328 973 Summary of Use: Control of certain insect and mite pests on pome fruit, stone fruit, berries, citrus, tropical fruit and nut crops. Date of Registration: 12 December 2006 Label Approval No: 60948/1ML/1206, 60948/1MLL/1206, 60948/5ML/1206, 60948/5MLL/1206, 60948/10ML/1206, 60948/10MLL/1206, 60948/20ML/1206, 60948/20MLL/1206, 60948/1206 Product Name: Ospray Mancozeb 750WG Fungicide Active Constituent/s: 750 g/kg mancozeb Applicant Name: Ospray Pty Ltd Applicant ACN: 110 199 169 Summary of Use: For the control of certain diseases of fruit, field crops, tobacco, turf, vegetables and ornamentals. Date of Registration: 13 December 2006 Label Approval No: 61485/25KG/1106 Product Name: Forgo Plus Seed Dressing Fungicide Active Constituent/s: 4 g/L cypermethrin, 200 g/L triticonazole. Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: For the control or suppression of various diseases in wheat and barley and control of various pests of stored wheat and barley. Date of Registration: 14 December 2006 Label Approval No: 60579/10/0806, 60579/0806 Product Name: Combik 250 Herbicide Active Constituent/s: 115 g/L diquat present as diquat dibromide, 135 g/L paraquat present as paraquat dichloride Applicant Name: Sinon Australia Pty Limited Applicant ACN: 102 741 024 Summary of Use: For the control of a wide range of grasses and broadleaf weeds in a range of situations including crop establishment. Date of Registration: 15 December 2006 Label Approval No: 60287/20L/0906, 60287/100L/0906, 60287/200L/0906, 60287/1000L/0906, 60287/0906

Product Name: Melpat Coppox WG Agricultural Fungicide/Bactericide Active Constituent/s: 500g/kg copper present as copper oxychloride. Applicant Name: Melpat International Pty Ltd Applicant ACN: 066 067 507 Summary of Use: For control of certain diseases on a range of fruit, vegetable and nut crops and ornamentals. Date of Registration: 18 December 2006 Label Approval No: 59562/1/1006, 59562/2/1006, 59562/5/1006, 59562/10/1006, 59562/12/1006, 59562/15/1006, 59562/20/1006, 59562/25/1006, 59562/100/1006, 59562/1006 Product Name: Agspray Chlorpyrifos 500EC Insecticide Active Constituent/s: 500 g/L chlorpyrifos Applicant Name: Agspray Chemical Co Pty Ltd Applicant ACN: 005 329 573 Summary of Use: For control of a range of insect pest of fruit, vegetables, oilseeds, cotton, cereals, pasture and turf. Date of Registration: 18 December 2006 Label Approval No: 60611/1/0806, 60611/5/0806, 60611/10/0806, 60611/20/0806, 60611/0806 Product Name: David Grays Thermal Fogging And ULV Insecticide Concentrate Active Constituent/s: 400 g/L piperonyl butoxide, 50 g/L bioresmethrin Applicant Name: David Gray & Co. Pty Limited Applicant ACN: 008 671 127 Summary of Use: For the indoor and outdoor control of flying insect pests and American cockroaches. Date of Registration: 19 December 2006 Label Approval No: 61237/1L/0706, 61237/2.5L/0706, 61237/5L/0706, 61237/10L/0706, 61237/20L/0706, 61237/50L/0706, 61237/60L/0706, 61237/100L/0706, 61237/110L/0706, 61237/200L/0706, 61237/210L/0706, 61237/1000L/0706 Product Name: Acclaim Herbicide Active Constituent/s: 200 g/L fluroxypyr as the methyl heptyl ester Applicant Name: Sipcam Pacific Australia Pty Ltd Applicant ACN: 073 176 888 Summary of Use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, millets, pastures, poppies, sorghum, sugar cane, sweet corn, winter cereals and for the control of woody weeds in agricultural non-

crop areas, commercial and industrial areas, forests, pastures and rights-of-way. Date of Registration: 19 December 2006 Label Approval No: 60495/20L/1006, 60495/110L/1006, 60495/1000L/1006, 60495/1006 Product Name: Amgrow Chemspray Disease Control Lime Sulphur Fungicide And Miticide Active Constituent/s: 190 g/L sulfur (s) present as polysulfide sulfur, 25 g/L sulfur as thiosulfate Applicant Name: Envirogreen Pty Ltd Applicant ACN: 069 900 456 Summary of Use: For control of certain insects, mites and fungus diseases on apples, pears, stone fruit, grapes, citrus, tomatoes and ornamentals. Date of Registration: 19 December 2006 Label Approval No: 61088/1/1006 Product Name: Miller Nu-Film-17 Non Ionic Extender-Sticker-Spreader Active Constituent/s: 904 g/L di-1-p-menthene Applicant Name: Miller Chemical & Fertilizer (Australia) Pty Ltd Applicant ACN: 086 969 628 Summary of Use: Non-ionic extender-sticker-spreader designed to control the life of pesticides. Date of Registration: 20 December 2006 Label Approval No: 61397/1-208L/0906 Product Name: Rural Telone Soil Fumigant Active Constituent/s: 945g/kg 1,3-dichloropropene. Applicant Name: S.A. Rural Agencies Pty Ltd Applicant ACN: 074644394 Summary of Use: For the control of plant parasitic nematodes in soil. Date of Registration: 20 December 2006 Label Approval No: 60921/80KG/0706 Product Name: Forgo Seed Dressing Fungicide/Insecticide Active Constituent/s: 4 g/L cypermethrin, 25 g/L triticonazole Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: For the control of covered smut, flag smut, and loose smut in wheat, covered smut and loose smut in barley and oats and for protection against pests of stored grain. Date of Registration: 21 December 2006 Label Approval No: 60578/10/0806, 60578/100/0806, 60578/0806

Product Name: Nufarm Agritone 750 Selective Herbicide Active Constituent/s: 750 g/L mcpa present as the dimethylamine salt Applicant Name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of Use: For selective control of broadleaf weeds in cereals, linseed, pastures, rice, sugarcane, field peas, linseed, flax and turf. Date of Registration: 22 December 2006 Label Approval No: 60505/20L/1206, 60505/110L/1206, 60505/1000L/1206, 60505/1206 Product Name: Kills Fast! Select Woolworths Low Irritant Surface Spray Active Constituent/s: 2.79 g/kg permethrin 25:75, 1.38 g/kg tetramethrin 20:80 Applicant Name: Woolworths Ltd Applicant ACN: 000 014 675 Summary of Use: Low irritant surface spray to kill crawling insects fast. Date of Registration: 22 December 2006 Label Approval No: 61349/350/1106 Product Name: Baygon Odourless Crawling Insect Surface Spray Active Constituent/s: 0.15 g/kg imiprothrin, 2.79 g/kg permethrin Applicant Name: S.C. Johnson & Son Pty Ltd Applicant ACN: 000 021 009 Summary of Use: For control of crawling and flying insects in the home. Date of Registration: 22 December 2006 Label Approval No: 60831/250/0107, 60831/350/0107 Product Name: Baygon Odourless Fast Knockdown Flying Insect Spray Active Constituent/s: 0.9 g/kg allethrin 20:80, 0.9 g/kg d-phenothrin, 4.05 g/kg tetramethrin Applicant Name: S.C. Johnson & Son Pty Ltd Applicant ACN: 000 021 009 Summary of Use: For the control of various flying and crawling insect pests in various situations in the home. Date of Registration: 22 December 2006 Label Approval No: 61386/200/0906 Product Name: Conquest Camquesta 500 Selective Herbicide Active Constituent/s: 500 g/L dicamba present as the dimethylamine salt Applicant Name: Conquest Agrochemicals Pty Ltd Applicant ACN: 098 814 932 Summary of Use: For the control of certain broadleaf weeds in winter cereals, pastures, conservation tillage, sugarcane, turf, rice and

non-crop areas. Date of Registration: 02 January 2007 Label Approval No: 61353/5L/0906, 61353/10L/0906, 61353/20L/0906, 61353/0906 Product Name: Barrell Chemicals Pool Calcium Hypochlorite Active Constituent/s: 700 g/kg chlorine present as calcium hypochlorite. Applicant Name: Arbay Pty Ltd T/A Barrell Chemicals Applicant ACN: 010 872 170 Summary of Use: For the control of algae and bacteria in swimming pools. Date of Registration: 03 January 2007 Label Approval No: 61314/10/1206, 61314/20/1206, 61314/40/1206 Product Name: Drax Ant Kill PF Active Constituent/s: 9 g/kg BORON as Boric Acid Applicant Name: Barmac Industries Pty Ltd Applicant ACN: 009 674 953 Summary of Use: For the control of Coastal Brown Ants in domestic, commercial and industrial situations, including food handling establishments. Date of Registration: 05 January 2007 Label Approval No: 54035/30/1205, 54035/60/1205 Product Name: Dow Agrosciences LV Ester 600 Herbicide Active Constituent/s: 600 g/L 2,4-D as the ethyl hexyl ester Applicant Name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of Use: A low-volatile, selective, systemic herbicide that is principally foliarly absorbed, applied post-emergence-weed and either post-emergence-crop or pre-sowing/fallow or for pre-harvest preparation, for the control of a wide range of broad leaf weeds, in a range of crops, pastures and non-agricultural situations. Date of Registration: 08 January 2007 Label Approval No: 61030/20/1206, 61030/100/1206, 61030/110/1206, 61030/1000/1206, 61030/1206

Product Name: Mortein Outdoor Easy Reach Crack And Crevice Spray Active Constituent/s: 0.30 g/kg imiprothrin, 0.30 g/kg deltamethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: Crack and crevice spray to kill hidden insects in cracks and crevices for up to 3 months. Date of Registration: 9 January 2007 Label Approval No: 61473/350g/1106 Product Name: Nufarm Cabrio 200 WG Fungicide Active Constituent/s: 200 g/kg pyraclostrobin Applicant Name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of Use: For the control of downy and powdery mildew in grapevines. Date of Registration: 10 January 2007 Label Approval No: 61205/2-10kg/0806 Product Name: Garden King Grubkil Lawn Grub & Beetle Killer Active Constituent/s: 50g/L chlorpyrifos. Applicant Name: Envirogreen Pty Limited Applicant ACN: 069 900 456 Summary of Use: For the control of lawn beetles, lawn grubs, armyworms, African black beetle, ants, spiders and cockroaches in the home garden. Date of Registration: 11 January 2007 Label Approval No: 61257/500/1106 Product Name: Agrifop 375 Selective Herbicide Active Constituent/s: 375 g/L diclofop-methyl Applicant Name: Agri Environmental Pty Ltd Applicant ACN: 105 841 110 Summary of Use: For the post-emergent control of annual ryegrass, common barb grass and wild oats in peas, linseed and other crops as well as the control of crowsfoot grass in turf. Date of Registration: 12 January 2007 Label Approval No: 59988/20/1106, 59988/55/1106, 59988/110/1106, 59988/200/1106, 59988/1106 Product Name: Senator 600 Red Flowable Seed Treatment Active Constituent/s: 600 g/L imidacloprid Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Use: Seed dressing for the control of various soil and foliar pests in a range of field crops and the prevention of spread of barley yellow dwarf virus in cereal crops.

Date of Registration: 12 January 2007 Label Approval No: 61163/10L/1106, 61163/100L/1106, 61163/200L/1106 Product Name: Crop Care LV Ester 680 Herbicide Active Constituent/s: 680g/L 2,4-D present as the 2-ethyl hexyl ester Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Use: A low-volatile, selective, systemic herbicide that is principally foliar absorbed, applied post-emergence-weed and either post-emergence-crop or pre-sowing/fallow or for pre-harvest preparation, for the control of a wide range of broadleaf weeds, in a range of crops, pastures and non-agricultural situations. Date of Registration: 16 January 2007 Label Approval No: 61166/20L/1106, 61166/110L/1106, 61166/1000L/1106, 61166/1106 Product Name: Ripper 480 Herbicide Active Constituent/s: 480 g/L glyphosate present as the isopropylamine salt. Applicant Name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of Use: For the control of many annual, perennial and woody weeds. Date of Registration: 18 January 2007 Label Approval No: 60370/20/0806, 60370/100/0806, 60370/110/0806, 60370/1000/0806, 60370/0806 Product Name: Mortein 30 Nights Protection Odourless Mozzie Zapper Active Constituent/s: 14.22 g/L esbiothrin, 773 g/L hydrocarbon liquid. Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: For use with an electrical device as a mosquito repellent in the home. Date of Registration: 18 January 2007 Label Approval No: 60592/25mL/0606, 60592/25mLP/0606

Product Name: Nufarm Nuprid 600 Flowable Seed Dressing Insecticide Active Constituent/s: 600 g/L imidacloprid Applicant Name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of Use: For the control of various soil and foliar pests in a range of field crops and the prevention of spread of barley yellow dwarf virus in cereal crops. Date of Registration: 18 January 2007 Label Approval No: 60858/10L/0107, 60858/100L/0107, 60858/200L/0107, 60858/1000L/0107 Product Name: Senator 600 Flowable Seed Treatment Active Constituent/s: 600 g/L imidacloprid. Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Use: For the control of various soil and foliar pests in a range of field crops and the prevention of spread of barley yellow dwarf virus in cereal crops. Date of Registration: 19 January 2007 Label Approval No: 60857/10L/0107, 60857/100L/0107, 60857/200L/0107, 60857/1000L/0107 Product Name: Ospray Spray-Out 250 Herbicide Active Constituent/s: 115 g/L diquat present as diquat dibromide, 135 g/L paraquat present as paraquat dichloride Applicant Name: Ospray Pty Ltd Applicant ACN: 110 199 169 Summary of Use: For control of a wide range of grasses and broadleaf weeds. Can be utilised in crop establishment programs. Date of Registration: 19 January 2007 Label Approval No: 60991/5L/1106, 60991/20L/1106, 60991/110/1106, 60991/200L/1106, 60991/1000L/1106, 60991/1106 Product Name: Farmoz Clincher Plus Herbicide Active Constituent/s: 960 g/L metolachlor. Applicant Name: Farmoz Pty Limited Applicant ACN: 050 328 973 Summary of Use: For the control of certain annual grasses and broadleaf weeds in certain crops. Date of Registration: 19 January 2007 Label Approval No: 60767/20/0107, 60767/20R/0107, 60767/110/0107, 60767/110L/0107, 60767/1000/0107, 60767/0107

4.VARIATIONS Product Name Applicant Name: Applicant ACN: Summary of Variation: Date of Variation: Label Approval No: Product Name: Macphersons Zest Non-Ionic Surfactant Applicant Name: Ronic International Pty Limited Applicant ACN: 101 193 131 Summary of Variation: Variation of label approval to vary the application use rate in certain situations and add 200L pack size to registration details. Date of Variation: 08 December 2006 Label Approval No: 58169/5L/0406, 58169/10L/0406, 58169/20L/0406, 58169/200L/0406 Product Name: Superway Glyphosate CT 450 Herbicide Applicant Name: Superway Garden Ag & Pest Products Pty Ltd Applicant ACN: 056 553 274 Summary of Variation: Variation of the label approval to copy uses from a closely similar reference product, update the label in accordance with the Ag labeling code and add additional pack sizes. Date of Variation: 11 December 2006 Label Approval No: 47743/5L/0306, 47743/20L/0306, 47743/110L/0306, 47743/200L/0306, 47743/1000L/0306, 47743/0306 Product Name: Hammer Herbicide Applicant Name: FMC Australasia Pty Ltd Applicant ACN: 095 326 891 Summary of Variation: Variation of the label approval to extend the use to include weed control in forestry plantations, all treefruits, grass based pastures and for desuckering in grapevines. Date of Variation: 13 December 2006 Label Approval No: 53696/1L/1006, 53696/2L/1006, 53696/5L/1006, 53696/10L/1006, 53696/1006

Product Name: Dupont Vydate L Insecticide/Nematicide Applicant Name: Du Pont (Australia) Ltd Applicant ACN: 000 716 469 Summary of Variation: Variation of label approval to extend the use to include control of Root knot nematode in capsicum. Date of Variation: 21 December 2006 Label Approval No: 33297/10/1206, 33297/50-200/1206 Product Name: Nufarm Unite 720 Fungicide Applicant Name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of Variation: Variation to include control of various diseases of turf, lawns, bowling greens & golf greens in various states and to include an additional pack size (1000L). Date of Variation: 11 January 2007 Label Approval No: 58564/5L/1106, 58564/10L/1106, 58564/20L/1106, 58564/200L/1106, 58564/1000L/1106 Product Name: Bollgard II Cotton Event 15985 Applicant Name: Monsanto Australia Limited Applicant ACN: 006 725 560 Summary of Variation: Product label and conditions of registration varied to remove restriction on planting Bollgard II Cotton Event 15985 north of 22 degrees south. Date of Variation: 16 January 2007 Label Approval No: 55786/1206 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: NV Transam Injection Active Constituent/s: 200 mg/mL dimethyl sulfone Applicant Name: Nature Vet Pty Limited Applicant ACN: 002 692 426 Summary of Use: An intravenous injection containing sulfur to be used by or under the direction of a registered veterinarian in horses with selected musculo-skeletal disorders. Date of Registration: 2 January 2007 Label Approval No: 59545/100ML/0107 3. VETERINARY PRODUCTS BASED

ON EXISTING ACTIVE CONSTITUENTS:

Product Name: Summerland Serums' Multi-Brown Snake Antivenom Active Constituent/s: 1500 units brown snake antivenom Applicant Name: K.J, J.A And J.M Curtin T/A Summerland Serums Summary of Use: To treat animals that are suffering from the neurotoxic effects of envenomation by the three species of Brown Snake most commonly found in Australia – Common Brown Snake (Pseudonaja textilis), the Western Brown Snake (P nuchalis), and the Dugite (P affinis).

Date of Registration: 27 November 2006 Label Approval No: 56843/10/0906 Product Name: Summerland Serums' Tiger/Multi-Brown Snake Antivenom Active Constituent/s: 4000 units brown snake antivenom, 3000 units tiger snake antivenom. Applicant Name: K.J, J.A And J.M Curtin T/A Summerland Serums Summary of Use: To treat animals that are suffering from the neurotoxic effects of envenomation by either the Tiger Snake (Notechis scutatus) or one of three species of Brown Snake most commonly found in Australia – the Common Brown Snake (Pseudonaja textilis), the Western Brown Snake (P nuchalis), and the Dugite (P affinis). It also neutralises the effects of the Black Snakes (Pseudechis species), including the Mulga or King Brown Snake (Pseudechis australis) and the Red-bellied Black Snake (Pseudechis porphyriacus), as well as the Copperhead Snake (Austrelaps superbus), the Rough Scaled or Clarence River Snake (Tropidechis carinatus), the Small-Eyed Snake (Cryptophis nigresens), and the Whip Snake (Demansia species), and the Tasmanian and Chappell Island Black Tiger Snakes (Notechis ater). Date of Registration: 27 November 2006 Label Approval No: 56767/20/0906 Product Name: Lethapharm Euthanasia Injection Active Constituent/s: 200 mg/mL pentobarbitone sodium Applicant Name: Bomac Animal Health Pty Limited Applicant ACN: 084 248 206 Summary of Use: Euthanasia solution for cats and dogs. Date of Registration: 5 December 2006 Label Approval No: 59941/100mL/1206, 59941/500mL/1206 Product Name: IVX Clindamycin Hydrochloride Oral Solution Active Constituent/s: 25 mg/mL clindamycin as clindamycin hydrochloride Applicant Name: IVX Animal Health Inc Summary of Use: For the treatment of infected wounds, abcesses, dental infections and osteomyelitis in dogs and cats caused by aerobic and anaerobic bacteria susceptible to clindamycin. Date of Registration: 5 December 2006 Label Approval No: 60039/20mL/0606 Product Name: IVX Oxytocin 20 IU/mL Injection Active Constituent/s: 20 IU/mL oxytocin.

Applicant Name: IVX Animal Health Inc Summary of Use: For obstetrical use in domestic animals and mild letdown in cows and sows. Date of Registration: 6 December 2006 Label Approval No: 59012/100ML/0606, 59012/0606 Product Name: Biomin C-Ex Active Constituent/s: Stabilised lactic acid bacteria of enterococcus faecium strain Biomin IMB 52 1 x 1013 CFU/kg Applicant Name: Biomin (Australia) Pty Ltd Applicant ACN: 102 287 570 Summary of Use: An aid in the establishment of gastrointestinal microflora of day old poultry chicks. Date of Registration: 6 December 2006 Label Approval No: 59446/300/1106, 59446/600/1106 Product Name: Coopers Tasvax 5in1 Vaccine For Sheep, Cattle And Goats Plus Selenium For Lambs Active Constituent/s: 0.5 g/L selenium as sodium selenate, Meets Ph.Eur. clostridium chauvoei toxoid and inactivated cells, 3.5 U/mL clostridium novyi Type B toxoid and inactivated cells, 5.0 U/mL clostridium perfringens Type D toxoid, 2.5 U/mL clostridium septicum toxoid, 2.5 U/mL clostridium tetani toxoid Applicant Name: Schering-Plough Pty Limited Applicant ACN: 000 235 245 Summary of Use: For use in cattle, sheep and goats against Pulpy Kidney, Blackleg, Malignant Oedema, Black Disease and Tetanus and to protect against selenium deficiency in lambs. Date of Registration: 7 December 2006 Label Approval No: 61165/500/0906, 61165/0906 Product Name: Noromectin Plus Broadspectrum Antiparasitic Injection For Cattle Active Constituent/s: 100 mg/mL clorsulon, 10 mg/mL ivermectin Applicant Name: Norbrook Laboratories Australia Pty Limited Applicant ACN: 080 972 596 Summary of Use: For the treatment and control of gastrointestinal roundworms, lungworms, eyeworms and adult liver flukes. Date of Registration: 12 December 2006 Label Approval No: 60795/50mL/1006, 60795/100mL/1006, 60795/250mL/1006, 60795/500mL/1006, 60795/1L/1006, 60795/1006 Product Name: Calcium Syrup Active Constituent/s: 24.25 g/100mL calcium lactobionate, 10.39 g/100mL calcium gluconate

Applicant Name: Novartis Animal Health Australasia Pty Limited Applicant ACN: 076 745 198 Summary of Use: A dietary supplement for the treatment of calcium deficiency in dogs and cats. Date of Registration: 21 December 2006 Label Approval No: 61111/200mL/1106, 61111/1L/1106 Product Name: Flopak VB12 Active Constituent/s: 28g/L calcium as calcium borogluconate, 0.02g/L vitamin b12 = cyanocobalamin. Applicant Name: Bomac Animal Health Pty Limited Applicant ACN: 084 248 206 Summary of Use: For the treatment of milk fever in cattle. Date of Registration: 9 January 2007 Label Approval No: 61443/500mL/1206 Product Name: Value Plus Prevent Tying-Up Powder Active Constituent/s: 90g Calcium (present as calcium carbonate), 95g Chloride (present as potassium chloride), 105g Potassium (present as potassium chloride), 91g Magnesium (present as magnesium oxide), 7mg Selenium (present as sodium selenite), 180mg Riboflavin, 1.4g Thiamine nitrate, 7.1g Alpha-tocopheryl acetate (Vitamin E). Applicant Name: Value Plus Animal Health Care Products Pty Ltd Applicant ACN: 094 221 913 Summary of Use: Oral mineral and vitamin powder for use in horses to aid in the prevention of ‘tying-up’. Date of Registration: 15 January 2007 Label Approval No: 60318/2kg/1106, 60318/4kg/1106, 60318/10kg/1106 Product Name: Ilium Pentobarbitone Sodium Anaesthetic Injection Active Constituent/s: 60 mg/mL pentobarbitone sodium Applicant Name: Troy Laboratories Pty Ltd Applicant ACN: 000 283 769 Summary of Use: For intravenous use as a general anaesthetic in dogs, cats, horses, cows, pigs and sheep. Date of Registration: 16 January 2007 Label Approval No: 61108/100MLP(1206), 61108/100MLG(1206), 61108/(1206) Product Name: Vet's Choice Ivermectin Pour On For Cattle Active Constituent/s: 10 mg/mL ivermectin. Applicant Name: Bomac Animal Health Pty Limited Applicant ACN: 084 248 206

Summary of Use: For the treatment and control of ivermectin-sensitive internal and external parasites of beef and cattle. Date of Registration: 18 January 2007 Label Approval No: 61297/500mL/1206, 61297/2.5L/1206, 61297/10L/1206 Product Name: Troy Applyte Rehydration Solution For Horses Active Constituent/s: 260 g/L glucose, 23.17 g/L phosphate as sodium phosphate dodecahydrate, 63.96 g/L chloride as sodium chloride and potassium chloride, 30.36 g/L potassium as potassium chloride, 2.93 g/L magnesium as magnesium sulfate heptahydrate, 11.59 g/L sulphate as magnesium sulphate heptahydrate, 40.45 g/L sodium as sodium chloride and sodium phosphate dodecahydrate Applicant Name: Troy Laboratories Pty Ltd Applicant ACN: 000 283 769 Summary of Use: Registration of an oral electrolyte rehydration solution for horses containing sodium, potassium, magnesium, chloride, sulphate, phosphate and glucose. Date of Registration: 18 January 2007 Label Approval No: 61017/1L/1206, 61017/5L/1206 4.VARIATIONS Product Name: Delaval Spray And Dip RTU Pre And Post Milking Teat Sanitiser With Emollient Applicant Name: Delaval Pty Ltd Applicant ACN: 004 210 459 Summary of Variation: Technical label change to add pre-milking to post milking product use as an aid in reducing the spread of mastitis-causing organisms. Date of Variation: 19 December 2006 Label Approval No: 58771/25L/1106, 58771/110L/1106, 58771/205L/1106, 58771/1000L/1106 5.. RESTRICTED PRODUCT

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

NOTICE

florasulam

in the product: TORPEDO HERBICIDE

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Dow AgroSciences Australia Ltd for the registration of a new product containing the active constituent florasulam in combination with another currently approved active clopyralid. The product, TORPEDO HERBICIDE, is for the residual broadleaf weed control in winter cereal crops.

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: TORPEDO HERBICIDE Applicant Company: Dow AgroSciences Australia Ltd. Active Constituents: Florasulam and Clopyralid Poisons Sheduling: Schedule 5 Statement of Claims: For the control of broadleaf weeds in barley triticale and wheat Pack sizes: 5L, 10L, 20L Withholding Period: Barley, wheat and triticale: Harvest: Not required when used as directed.

Grazing: Do not graze or cut treated crops for stock feed for 7 days after application.

Summary of the APVMA’s evaluation of TORPEDO HERBICIDE 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 TORPEDO HERBICIDE would not be

an undue hazard to the safety of people exposed to it during its handling and use. The Department of Health and Ageing, Office of Chemical Safety (Occupational Health and Safety) [OCS (OHS)] section has conducted a risk assessment on TORPEDO HERBICIDE and having set the appropriate personal protective equipment (PPE) requirements concluded that it can be used safely when used in accordance with the prescribed safety directions.

Florasulam has displayed low acute oral, dermal and inhalational toxicity in mice, rats and rabbits and is a slight skin and eye irritant in rabbits, but not a skin sensitiser in guinea pigs. The product, TORPEDO HERBICIDE, was considered likely to exhibit low acute oral, dermal and inhalational toxicity but likely to be a moderate skin and eye irritant; it is not likely to cause skin-sensitisation. The APVMA having considered the findings and recommendations of the OCS (OHS) evaluation accepts these findings and recommendations.

(ii) The APVMA is satisfied that the proposed use of TORPEDO HERBICIDE will not be an undue hazard to the safety of people using anything containing its residues. Residue data were assessed by the APVMA and Maximum Residue Limits (MRLs) and associated Withholding Periods (WHPs) are recommended for TORPEDO HERBICIDE when used on barley, triticale and wheat.

The recommended WHPs for TORPEDO HERBICIDE are stated on the draft label. Florasulum MRLs are recommended for cereal grains (*0.01mg/kg), edible offal (mammalian) (*0.01mg/kg), eggs (*0.01mg/kg), meat (mammalian) (*0.01mg/kg), milks (*0.01mg/kg), poultry meat (*0.01mg/kg), poultry, edible offal of (*0.01mg/kg). The relevant MRLs for the currently approved active chlorpyralid are already established. * denotes that the MRL was set at the limit of quantitation (LOQ).

(iii) The APVMA is satisfied that the proposed use of TORPEDO HERBICIDE is not likely to be harmful to human beings if used according to the product label directions. The proposed product has been assessed by the National Drugs and Poisons Scheduling Committee and has been included in Schedule 5 of the SUSDP. The appropriate Signal Heading appears on the label. First Aid and Safety Directions (hazard statements) for florasulam and TORPEDO HERBICIDE have been recommended by the Commonwealth Department of Health and Ageing, OCS (toxicology) section, and have been included on the label. The product will be formulated overseas and imported ready to use in HDPE containers. TORPEDO HERBICIDE is determined to be a hazardous substance, based on NOHSC hazard classification of active and non-active constituents and product toxicology information provided. The APVMA has considered the findings of its advisers on this criterion and accepts their recommendations.

(iv) The APVMA is satisfied that the proposed use of the product TORPEDO HERBICIDE

containing the new active constituent, florasulam, and the already registered active constituent, clopyralid for the post-emergent control or suppression of broadleaf weeds in barley, triticale and wheat is not likely to have an unintended effect that is harmful to harmful to animals, plants or things or to the environment.

The Department of the Environment and Heritage (DEH) has assessed the data in support of this product. Environmental fate studies indicate that florasulam is not expected to persist in soils. Similarly, florasulam is not expected to persist in aquatic systems. This lack of persistence coupled with the low application rate means that levels of florasulam in the environment from the proposed use will be low.

The proposed use of TORPEDO HERBICIDE is not likely to present unacceptable risk to birds, mammals, aquatic species other than algae and aquatic plants, beneficials, soil respiration processes or non-target plants. Risk to algae and aquatic plants is expected to be acceptable as a result of mitigation resulting from the specification of buffer distances with respect to water bodies and non-target vegetation and the recommendation that spraying not take place for 48 hours if heavy rains are expected. The APVMA has considered the findings of DEH and accepts its recommendations on this criterion.

(v) The APVMA is satisfied that the proposed use of TORPEDO HERBICIDE would not

adversely affect trade between Australia and places outside Australia. No detectable residues of florasulam are expected to occur in cereal grains, and therefore, unlikely to unduly prejudice trade in cereal. Furthermore, no export intervals are required for florasulam as there will be no detectable residues in the exported commodity; wheat and barley grain or processed wheat and barley foods. Forage and fodder treated crops, as well as grain, may be used as livestock feeds. Residues of florasulam in all of these commodities are expected to be below the LOQ. The feeding of these commodities to livestock is not expected to result in detectable residues in animal commodities, and thus prejudice trade in animal commodities. The overall risk to export trade in cereal and animal commodities from the registration of TORPEDO HERBICIDE is considered to be negligible.

In relation to its assessment of efficacy under section 14(3)(f), the APVMA proposes to determine that: (i) The APVMA is satisfied the data from trials supporting the efficacy of TORPEDO

HERBICIDE adequately demonstrates that under local conditions this product will be effective for the proposed uses.

Public Release Summary A Public Release Summary of the evaluation is available by contacting David Hutchison on telephone (02) 6210 4748 Written submissions on the APVMA’s proposal to grant the application for registration should be addressed in writing to: Ranjit Gajanayake Pesticides Program Australian Pesticides and Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604 Phone: (02) 6210 4760 Fax: (02) 6210 4776

NOTICE

THE RECONSIDERATION OF REGISTRATIONS OF PRODUCTS WHICH CONTAIN NEOMYCIN AND THEIR ASSOCIATED APPROVED LABELS

In accordance with Part 2, Division 4 of the Agvet Codes, the APVMA has commenced its reconsideration (hereafter referred to as review) of the registrations of oral, intra-mammary and injectable preparations of neomycin (including combination products with other antibiotics) and their associated approved labels. Neomycin is an aminoglycoside antibiotic contained in a variety of veterinary preparations including topical creams/ointments, eye drops/ointments, oral tablets, oral suspensions, injectables, and intra-mammary preparations for use in food-producing and non-food-producing animals. Two major uses of neomycin are for control of scours in calves and for treatment of mastitis in dairy cattle. The principal concerns raised by State departments of primary industry which led to the nomination of neomycin for review relate to (1) residue violations in food-producing animals treated with oral, intra-mammary and injectable preparations of neomycin, and (2) target animal safety. No residue or animal safety concerns have been identified for topical formulations, neomycin used as an antibiotic preservative in small animal vaccines, and semen extender powder preparations. Therefore, the review of neomycin will only consider oral, intra-mammary and injectable preparations products used to treat food-producing animals. The APVMA has commenced this review in order to assess whether it can be satisfied that continued use of, or any other dealing with, oral, intra-mammary and injectable preparations containing neomycin in accordance with the approved instructions for use: • would not be an undue hazard to the safety of people exposed to them during their

handling or people using anything containing their residues; and/or • would not unduly prejudice trade or commerce between Australia and other places outside

Australia; and/or • would not be likely to have an unintended effect that is harmful to animals, plants, things

or the environment. It also appears that the labels for products containing neomycin may not comply with the requirements provided by paragraph 14(3)(d) of the AgVet Codes and may not contain adequate instructions relating to the matters referred to in paragraph 14 (3)(g). The APVMA will review the following aspects of oral, intra-mammary and injectable preparations of neomycin and their associated approved labels:

a) Residues: i) the potential for residues to exceed standards, and thus pose an undue hazard

to the safety of people using anything containing their resides. i) the adequacy of withholding periods for the use of neomycin in food-

producing species.

b) Trade:

i) the potential for residues in export commodities to exceed the tolerances of importing countries, and unduly prejudice trade or commerce between Australia and places outside Australia.

c) Animal Safety:

i) the potential for products which contain neomycin to result in ototoxicity and nephrotoxicity in target food-producing animals.

The APVMA will also consider whether product labels carry adequate instructions and warning statements. Such instructions include:

• the circumstances in which the product should be used; • how the product should be used; • the times when the product should be used; • the frequency of the use of the product; • the re-treatment interval for the product; • the withholding period after the use of the product; • the disposal of the product and its container; • the safe handling of the product and first aid in the event of an accident caused by

handling the product; • any other matter prescribed by the regulations. The registered products which are oral, intra-mammary and injectable preparations of neomycin and which are within the scope of the review are listed in Tables 1 to 3 below. Table 1: Oral preparations Product number

Product Name Registrant Label approval number

36026

Scourban Oral Anti-diarrhoeal Suspension

Bomac Laboratories Limited (NZ)

36026/1201 36026/01

41468 Bronson and Jacobs Pty Ltd Neomycin Sulphate AG Grade

Bronson and Jacobs Pty Limited

Ψ

46414

VR Neo-Sulcin Scour Tablets Jurox Pty Limited 46414/0101

49788

Scour-X Oral Anti-diarrhoeal Suspension

Jurox Pty Limited 49788/0101 49788/01

52621 Neomycin Sulphate Upjohn Feed Additive Powder

Pfizer Animal Health a Div of Pfizer Australia Pty Ltd

52621/0802 52621/0100

52782 CCD Neomycin (Neomycin Sulphate Water Soluble Powder)

Ridley Agriproducts Pty Ltd T/A CCD Animal Health

52782/2/0705 52782/1003 52782/1100

54091 AAH Neomycin Sulphate Feed Additive Powder

Goodwale Pty Ltd T/A Allied Animal Health

54091/0802 54091/0901

58671 Neopharm Antibiotic Feed Additive Bomac Animal Health Pty Limited

58671/500g/0205 58671/1kg/0205 58671/10kg/0205

Ψ Labels transitioned from the States and not having an approval number

Table 2: Intra-mammary preparations Product number


38696 Special Formula 17900 Forte-V Lactating Intramammary Antibiotic Suspension

Pfizer Animal Health (a Div’n of Pfizer Australia Pty Ltd)

38696/0402 38696/0899

38698 Lincocin Forte Lactating Intramammary Antibiotic Solution


38698/0402 38698/0699

49851 Mastalone Blue Intramammary Suspension for Lactating cows


49851/01

Table 3: Injectable preparations Product number


36237

Jurox Neomycin Sulphate Injection Jurox Pty Limited 36237/100mL/0305 36237/02

36693

Neoject 200 Antibiotic Injection Delvet Pty Ltd Ψ

37241 Neomycin Penicillin 100/200 Aqueous Suspension for Intramuscular Injection

Intervet Australia Pty Limited

37241/100M/0405 37241/250M/0405 37241/100M/0504 37241/250M/0504 37241/0301

Ψ Labels transitioned from the States and not having an approval number The APVMA’s detailed reasons for the review can be found in the APVMA Neomycin Review Scope document, available on the APVMA website (http://www.apvma.gov.au). Interested parties are invited to make comments or submissions on the review scope document. These should reach the APVMA by 11 MAY 2007, by email to [email protected] or by mail to: Evaluator, Neomycin Review Australian Pesticides & Veterinary Medicines Authority PO Box E 240 KINGSTON ACT 2604 For further information, contact (02) 6210 4700 or [email protected].

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

mailto:[email protected]


_________________________________________________________________________________________________________________ * 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 OF 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: AUSTRALIAN PHARMACEUTICAL SERVICES PTY LIMITED ACN: 101 752 121 Units 21 & 23 APP House 14 Rodborough Rd FRENCHS FOREST NSW 2086

Product Types:* Category 6: Single Step Step(s) of Manufacture: Quality assurance (QA) of raw materials, analysis and testing (physical). Licence No: 6119 Full licence issued 06/12/06, with special conditions

AUSVETLAB PTY LTD trading as Australian Veterinary Serum Laboratories, as Trustee for David K Jones Family Settlement ACN for Trustee: 001 611 516 Kays Lane ALSTONVILLE NSW 2477

Product Types:* Category 1: Immunobiologicals (tick antiserum), immunobiologicals (snake antivenoms) Step(s) of Manufacture: Quality assurance (QA) of raw materials, serum collection, management and immunisation of donor animals, formulation including blending, aseptic filling, sterilisation (filtration), packaging, labelling, analysis and testing (physical, sterility testing), storage and release for supply. Licence No: 1063 Full licence issued 07/12/06

CONTRACT PHARMACEUTICAL SERVICES OF AUSTRALIA PTY LIMITED ACN: 003 131 548 5 Eden Park Drive NORTH RYDE NSW 2113

Product Types:* Category 6: Single Step Step(s) of Manufacture: Quality assurance (QA) of raw materials,filling, packaging and labelling, strip, blister and sachet packaging, storage and release for supply. Licence No: 6113 Full licence issued 06/12/06, with special conditions


2PHARMAPAK TECHNOLOGIES PTY LTD ACN: 093 794 104 7 Inman Road DEE WHY NSW 2099

Product Types:* Category 6: Single Step Step(s) of Manufacture: Quality assurance (QA) of raw materials, filling, packaging, labelling, strip, blister and sachet packaging, storage, and release for supply Licence No: 6107 Full licence issued 06/12/06, with special conditions

2. CHANGES TO EXISTING LICENCES: ARISTOPET PTY LTD ACN: 009 697 152 110 Lavarack Ave EAGLE FARM QLD 4009

Product Types:* Category 2: Tablets, capsules, creams/lotions, ointments, sprays, aerosols, liquids. Category 3: Liquids, sprays, powders and tablets (soluble for aquarium). Step(s) of Manufacture: Quality Assurance (QA) of raw materials, formulation including blending, granulation, dry milling of powders, tableting, filling, packaging, labelling, analysis and testing (physical), storage and release for supply. Licence No: 2085 Amended licence issued 04/12/06, change of key personnel.

CUMBERLAND INDUSTRIES LTD T/As: FILPAC ACN: 002 534 670 59-65 Kurrajong Avenue MT DRUITT NSW 2770

Product Types:* Category 4: Premixes, supplements Step(s) of Manufacture: Formulation including blending, filling, packaging, labelling, strip, blister or sachet packaging, storage, and release for supply. Licence No: 4070 Amended licence issued 05/12/06, change of key personnel.


3DAVID GRAY & CO PTY LIMITED ACN: 008 671 127 2 Rawlinson Street O’CONNOR WA 6163

Product Types:* Category 3: Liquids, sprays and powders Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, aerosol filling from bulk, analysis and testing (physical and chemical), storage and release for supply. Licence No: 3003 Amended licence issued 15/12/06, extension of licence scope.

EFFEM FOODS PTY LTD Trading As: Masterfoods Australia/New Zealand ACN: 008 454 313 Howard Street WODONGA VIC 3690

Product Types:* Category 2: Palatable ingestable chews Category 4: Moist therapeutic pet foods Step(s) of Manufacture: Formulation including blending, filling (including canning), packaging, labelling, strip, blister or sachet packaging, microbiological reduction treatment (heat), analysis and testing (physical, chemical and microbiological), storage and release for supply. Licence No: 2106 Amended licence issued 05/12/06, change of key personnel.

NEW HORIZONS ENTERPRISES LIMITED ACN: 002 066 604 15 Twin Road NORTH RYDE NSW 2113

Product Types:* Category 6: Single Step Step(s) of Manufacture: Secondary packaging and secondary labelling. Licence No: 6076 Amended licence issued 05/12/06, change of key personnel.


4SYPHARMA PTY. LTD. ACN: 114 895 064 27 Healey Road DANDENONG VIC 3175

Product Types:* Category 1: Sterile products Category 2: Creams/lotions, ointments, pastes, powders, liquids, suspensions Category 4: Premixes, supplements Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, wet milling, filling, aseptic filling, packaging, labelling, sterilisation (heat, filtration), analysis and testing (physical, chemical, microbiological, sterility testing), storage and release for supply. Licence No: 1082 Amended licence issued 20/12/06, extension of scope, variation of condition.

TROY LABORATORIES PTY LTD ACN: 000 283 769 98 Long Street SMITHFIELD NSW 2164

Product Types:* Category 1: Sterile products. Category 2: Creams/lotions, ointments, pastes, powders, sprays, suspensions and liquids. Category 3: Liquids, sprays and powders. Category 4: Supplements. Step(s) of Manufacture: Quality Assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, aseptic filling, sterilisation (heat and filtration), microbiological reduction treatment (heat and filtration), analysis and testing (physical and chemical), storage and release for supply. Licence No: 1006 Amended licence issued 15/12/06, extension of licence scope, change of key personnel.

3. LICENCE CANCELLATIONS: (The APVMA has cancelled the following licences under section 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code]). AUSTRALIAN VETERINARY SERUM LABORATORIES 20-22 Uralba Street LISMORE NSW 2480

Licence No: 1024 Cancelled: 15/12/06 Reason for cancellation: s127(1)(e)


5CONTRACT PHARMACEUTICAL SERVICES OF AUSTRALIA PTY LIMITED ACN: 003 131 548 44-48 Waterloo Road NORTH RYDE NSW 2113

Licence No: 2114 Cancelled: 15/12/06 Reason for cancellation: s127(1)(d)

PHARMAPAK TECHNOLOGIES PTY LTD ACN: 093 794 104 Unit 10, 7 Jubilee Avenue WARRIEWOOD NSW 2102

Licence No: 2136 Cancelled: 15/12/06 Reason for cancellation: s127(1)(d) & (e)

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

APVMA Contact: Kathryn Winterton Quality Assurance and Compliance Australian Pesticides and Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604 Ph: (02) 6210 4804 Fax: (02) 6210 4813 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, 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 APVMA Gazette No.1, 2 January 2007. Application No Product/Active Constituent Name

37521 NOT AVAILABLE 39090 DUPONT DIURON XG HERBICIDE 39968 FARMOZ AMPLIFY SPRAY TANK ADJUVANT 40067 STARANE 333 HERBICIDE 40615 RYGEL CROPWETT 1000 40696 NOT AVAILABLE 39567 CCD VIRELIM 40454 BUFF-IT SPRAY ADJUVANT 40511 AEROGARD FAMILY PROTECTION LOW IRRITANT INSECT REPELLENT ROLL ON 40512 AEROGARD FAMILY PROTECTION LOW IRRITANT INSECT REPELLENT SPRAY 40513 AEROGARD FAMILY PROTECTION LOW IRRITANT INSECT REPELLENT 40628 NOT AVAILABLE 40926 COUNTRY BIFENTHRIN DUO 100 EC TERMITICIDE & INSECTICIDE 40955 MCPA-2-ETHYLHEXYL ESTER 41047 NOT AVAILABLE 41064 ELANCO AF0248 TYLAN GRANULAR TYLOSIN PHOSPHATE 41083 NOT AVAILABLE 41234 INNOVA IPRODIONE 250 FLOWABLE SEED DRESSING 41251 NOT AVAILABLE 41255 NOT AVAILABLE 41322 NOT AVAILABLE 41323 NOT AVAILABLE 40887 DURAFLO T SEED TREATMENT 41018 OSPRAY CLODINAFOP 240 EC SELECTIVE HERBICIDE 41236 FARMOZ WIPE-OUT BIO NON-RESIDUAL HERBICIDE 41252 HORTICO TRIFORINE ROSE FUNGICIDE 39615 CLARK RUBBER FILTRITE SPA BROMINE GRANULES 39931 NOT AVAILABLE 39946 NOT AVAILABLE 39955 H20 LITHIUM HYPOCHLORITE 39979 DAVID GRAYS CARBARYL GARDEN INSECTICIDE 40136 GRAMOXONE 250 HERBICIDE 40336 GENFARM CLODINAFOP 240EC SELECTIVE HERBICIDE 40349 SOLFAC PRO RESIDUAL INSECTICIDE 40469 NOT AVAILABLE 40622 MACSPRED SIMAZINE 900 DF HERBICIDE 40658 MAXIMXL FUNGICIDE SEED TREATMENT 40862 NOT AVAILABLE 40990 NOT AVAILABLE 40992

40995 NOT AVAILABLE 40999 NOT AVAILABLE 41009 ACTARA INSECTICIDE 41060 POWER PAK HEAVY DUTY DAIRY CLEANER 41079 NOT AVAILABLE 41080 NOT AVAILABLE 41095 DIETHYLTOLUAMIDE 41097 NOT AVAILABLE 41098 FLUQUINCONAZOLE 41152 NOT AVAILABLE 41174 CRUISER 500 FS INSECTICIDE SEED TREATMENT 41194 OSPRAY COURAZE 350 SC INSECTICIDE 41211 FARMOZ APHIDEX WG APHICIDE 41219 FLUMETSULAM 41221 CLODINAFOP-PROPARGYL 41222 2,4-D-2-ETHYLHEXYL ESTER 41253 INNOVA TRIFLURALIN 480 HERBICIDE 41272 INNOVA PICLORAM + MCPA 242 HERBICIDE 41279 VALOR 500 WG HERBICIDE 41285 NOT AVAILABLE 41297 INNOVA FLUTRIAFOL 250 IN-FURROW + FOLIAR FUNGICIDE 41298 NOT AVAILABLE 41301 TRADELANDS ORYZALIN 500 FLOWABLE HERBICIDE 41302 NOT AVAILABLE 41303 ELANCO AFO252 NARASIN GRANULAR 41327 TITAN TEBUCONAZOLE 430SC FUNGICIDE 41328 SMARTFILM TERMITE PROTECTION 41329 INNOVA FLUROXYPYR 200 HERBICIDE 41345 MATTER 240EC SELECTIVE HERBICIDE 41358 RENTOKIL BROMAKIL KILLS RATS AND MICE! 41363 OSMOSE DETERMITE ULTRA LOW ODOUR TIMBER FRAMING INSECTICIDE 41372 MITE MASTER 290 INSECTICIDE 41371 AW OMETHOATE 290SL INSECTICIDE 41373 NOT AVAILABLE 41384 AQUAVIC ""ALGAENON+"" POOL ALGAECIDE AND SANITISING SYSTEM 41402 NOT AVAILABLE 41404 PLASMITE PATROL 400 MASONRY & TIMBER INSECTICIDE 37426 NOT AVAILABLE 39361 NOT AVAILABLE 40882 FARMOZ GEM FUNGICIDE 40951 PHIBROMONENSIN 400 MONENSIN FEED ADDITIVE PREMIX 40986 PERMATEK IM 30 INSECTICIDE 41206 SELECT HERBICIDE 41375 NOT AVAILABLE 38751 UNITED FARMERS T-OIL SPRAY TANK ADJUVANT 39566 CROP CARE JOCKEY SYSTEMIC SEED TREATMENT 40164 NOT AVAILABLE 40169 NOT AVAILABLE 40412 RAINBOW TELCO & POWER WASP & ANT SPRAY 41103 OSMOSE DETERMITE ULTRA LOW ODOUR TIMBER FRAMING INSECTICIDE RTU 41147 CROP CARE COBBER 475 HERBICIDE 41154 NOT AVAILABLE 41164 NOT AVAILABLE 41300 UNITED FARMERS LV ESTER 600 HERBICIDE

A change or correction has been made to the following summaries:

Application No Product/Active Constituent Name 39945 COOPERS TASVAX 5IN1 VACCINE FOR SHEEP, CATTLE AND GOATS PLUS

SELENIUM FOR LAMBS

AMENDMENT No.8J

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_standard.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) Abamectin DELETE: VL 0482 Lettuce, Head T0.05 ADD: VL 0482 Lettuce, Head 0.05 VL 0483 Lettuce, Leaf T0.2 Azoxystrobin DELETE: TN 0085 Tree nuts T0.02 ADD: TN 0660 Almonds *0.01 TN 0085 Tree nuts (except almonds) T0.02 Bifenazate ADD: TN 0660 Almonds T0.1 Carfentrazone-ethyl DELETE: FT 0305 Olives *0.05 ADD: FT 0026 Assorted tropical and sub tropical fruits (edible peel) *0.05 FI 0030 Assorted tropical and sub tropical fruits (inedible peel) *0.05 FC 0001 Citrus fruits *0.05 Fenvalerate DELETE: SO 0088 Oilseed 0.5

ADD: SO 0089 Oilseed, except peanut 0.5 SO 0697 Peanut T0.1 Imidacloprid ADD: FT 0307 Persimmon, Japanese T1 Oxamyl ADD: VO 0445 Peppers, Sweet [capsicums] 1 Tebufenozide ADD: FI 0358 Rambutan T3 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) Azoxystrobin DELETE: Almond Hulls T5 ADD: Almond Hulls 5 Bifenazate ADD: Almond Hulls T5 Carfentrazone-ethyl ADD: Pastures *0.05

TABLE 5: USES OF SUBSTANCES WHERE MAXIMUM RESIDUE LIMITS ARE NOT NECESSARY SUBSTANCE USE Hydramethylnon ADD: For use as an insecticide to control ants on fallow sugarcane situations Note The following is a correction from the APVMA Gazette dated 2nd January 2007, 7J page 21. Iodine (elemental) DELETE: For use as a teat dip (pre-milking and post-milking) at up to 1.0% available iodine from iodine or iodine-complexes ADD: For use as a pre-milking teat dip at up to 0.1% available iodine from iodine or iodine-complexes For use as a post-milking teat dip at up to 0.5% available iodine from iodine or iodine-complexes For further information please contact: Joan Downing Chemistry & Residues Program Phone: (02) 6272 3795 Fax: (02) 6272 3551

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. 1, 2 January 2007

For Use in Agricultural Chemical Products:

http://www.apvma.gov.au/actives/downloads/aa_AK.pdf

http://www.apvma.gov.au/actives/downloads/aa_LZ.pdf

Amicarbazone ARYSTA LIFESCIENCE NORTH AMERICA CORPORATION

M & H LABORATORIES CO LTD 425 WOLHADONG YEOSU CITY JEON-NAM 555-290 KOREA

60115

Alpha-cypermethrin UNITED PHOSPHORUS LIMITED

UNITED PHOSPHORUS LIMITED 3-11 G.I.D.C., VAPI 396195 GUJARAT STATE INDIA

60753

Carbofuran SINON AUSTRALIA PTY LIMITED

SINON CORPORATION NO 111, CHUNG SHAN RD TA-TU HSIANG TAICHUNG HSIEN 432 TAIWAN OR SINON CORPORATION NO 2, XINSHEN ROAD XINSI TOWN FENGXIAN DISTRICT SHANGHAI P.R. CHINA

60646

Clethodim FARMOZ PTY LIMITED HEBEI WANQUAN PESTICIDE FACTORY KONGJIAZHUANG, WANQUAN, 072609 P.R. CHINA

61330

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

61318

Imazapic ECHEM (AUST) PTY LIMITED LIANYUNGANG HETIAN CHEMICAL CO LTD NO 1 JINGSHI ROAD GUANNAN INDUSTRY DEV ZONE LIANYUNGANG JIANGSU PR CHINA

61266

Iodomethane ARYSTA LIFESCIENCE NORTH AMERICA CORPORATION

DEEPWATER CHEMICALS INC 1210 AIRPARK DR WOODWARD OKLAHOMA 73801 USA

59053

Metarhizium anisopliae var. acridum

BECKER UNDERWOOD PTY LTD

BECKER UNDERWOOD PTY LTD RMB 1084 PACIFIC HWY SOMERSBY NSW 2250 AUSTRALIA

61092

Metham-sodium manufacturing concentrate

PACIFIC AGRISCIENCE PTY LTD

CORONA INDUSTRIES PTY LTD 38A THOMAS RD KWINANA WA 6167 AUSTRALIA

60773

Prosulfocarb SYNGENTA CROP PROTECTION PTY LIMITED

IHARA CHEMICAL INDUSTRY CO LTD 1800 NAKANOKO FUJIKAWA-CHO IHARA-GUN SHIZUOKA JAPAN

60358

Tolclofos-methyl GENFARM CROP PROTECTION PTY LTD

JIANGSU LIANYUNGANG DONGJIN CHEMICAL CO. LTD JIANGSU LIANYUNGANG, JIANGSU PROVINCE P.R. CHINA

61288

For enquiries please contact: Chemistry & Residues Program Australian Pesticides and Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604 Phone: 02 6210 4818 Fax: 02 6210 4840 Email: [email protected]

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