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Transcript of APVMA Gazette no. 9, 10 May 2011 - Australian Pesticides ...
No. APVMA 9, Tuesday, 10 May 2011 Published by The Australian Pesticides & Veterinary Medicines Authority
AGRICULTURAL AND
VETERINARY CHEMICALS
The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be published in the Gazette containing details of the registration of agricultural and veterinary chemical products and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code and related legislation also requires certain other notices to be published in the Gazette.
26466 Cat. No. 0189623
ISSN 1837 - 7629
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 2
© Commonwealth of Australia 2011
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process
without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be
addressed to:
Commonwealth Copyright Administration
Copyright Law Branch
Attorney-General’s Department
Robert Garran Offices
National Circuit
CANBERRA ACT 2600
Email: [email protected]
Website: www.ag.gov.au/cca
GENERAL INFORMATION
The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of the
registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as required by the
Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material issued by the
APVMA.
Pursuant to section 53(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications made
for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in quarterly
statistical reports.
DISTRIBUTION AND SUBSCRIPTION
From February 2010, the APVMA will publish the APVMA Gazette in electronic format only. The APVMA Gazette and information
about subscribing to the gazette alert service are available on the APVMA website, www.apvma.gov.au.
Copies of the APVMA Gazette from November 1999 until July 2009 will remain available from the APVMA website.
APVMA CONTACTS
For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4871
For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Notice of Registrations 4 Agricultural Chemical Products ..............................................................................................................................................4 Veterinary Chemical Products..............................................................................................................................................12
Other Notices 17 Preliminary Review Findings Related to Approvals and Registrations of Carbendazim.......................................................17 Amendments to the APVMA MRL Standard.........................................................................................................................22 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code ..................................................28 Addendum to the Record of Approved Active Constituents..................................................................................................33 Application Summaries.........................................................................................................................................................35
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 4
NOTICE OF REGISTRATIONS
Agricultural 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.
1. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Titan Diflufenican + MCPA Selective Herbicide Active Constituent/s: 25g/L Diflufenican, 250g/L MCPA present as the Ethyl Hexyl Ester Applicant Name: Titan AG Pty Ltd Applicant ACN: 122 081 574 Summary of Use: For control of certain broadleaf weeds in winter cereals and clover. Date of Registration: 18 April 2011 Label Approval No: 65650/51496
Product Name: Grazit Herbicide Active Constituent/s: 100g/L Picloram present as the Hexyloxypropylamine Salt, 300g/L Triclopyr present as the
Butoxyethyl Ester Applicant Name: Hextar Chemicals Pty Ltd Applicant ACN: 114 525 709 Summary of Use: For control of a range of environmental and noxious woody and herbaceous weeds. Date of Registration: 18 April 2011 Label Approval No: 64736/49102
Product Name: Coles Outdoor & Indoor Surface Spray Active Constituent/s: 0.5g/L Bifenthrin. Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: For repellency and control of various household insect pests. Date of Registration: 18 April 2011 Label Approval No: 65987/52437
Product Name: Contax Winter Oil Insecticide Active Constituent/s: 861g/L Petroleum Oil. Applicant Name: Victorian Chemical Company Proprietary Limited Applicant ACN: 004 188 863 Summary of Use: For dormant season control of certain mite and scale insects on pome and stone fruit trees
and grapevines. Date of Registration: 18 April 2011 Label Approval No: 66156/52883
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 5
Product Name: Raid Max Bug Defence Do-It-Yourself Outdoor Home Surface Spray Active Constituent/s: 0.5g/L Bifenthrin. Applicant Name: S.C. Johnson & Son Pty Ltd Applicant ACN: 000 021 009 Summary of Use: For use in outdoor situations to control cockroaches, ants, mosquitoes, spiders, flies, fleas
and papernest wasps. Date of Registration: 18 April 2011 Label Approval No: 66045/52586
Product Name: Resource Gardening Glypho 360 Non Selective Herbicide Active Constituent/s: 360g/L glyphosate present as the isopropylamine salt Applicant Name: Amgrow Pty Ltd Applicant ACN: 100 684 786 Summary of Use: For use in various situations to control annual and perennial broadleaf and grass weeds. Date of Registration: 19 April 2011 Label Approval No: 66086/52672
Product Name: Ridomil Gold 480 SL Systemic Fungicide Active Constituent/s: 480g/L metalaxyl-m Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 Summary of Use: For the control of pink rot in potatoes, blue mould in tobacco seedbeds and heart rot and root
rot in pineapples. Date of Registration: 20 April 2011 Label Approval No: 64812/49362
Product Name: Talon Ant Killer Gel Active Constituent/s: 0.1g/kg thiamethoxam Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 Summary of Use: For the control of ants. Date of Registration: 20 April 2011 Label Approval No: 65959/52384
Product Name: Chaindrite Utility Insecticide Active Constituent/s: 200g/L Imidacloprid. Applicant Name: Sherwood Chemicals Public Company Limited Applicant ACN: N/A Summary of Use: For use in the control of various insect pests in cotton, fruit, vegetable and ornamentals. Date of Registration: 20 April 2011 Label Approval No: 64198/49707
Product Name: Pacific Fire Spray Adjuvant Active Constituent/s: 116g/L Non-ionic Surfactant, 700g/L Ethyl and Methyl Esters of Vegetable Oil. Applicant Name: Pacific Agriscience Pty Ltd Applicant ACN: 096 082 316 Summary of Use: For assisting the effectiveness of herbicides and other agricultural chemicals. Date of Registration: 20 April 2011 Label Approval No: 65914/52285
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 6
Product Name: Country Phospot 200 Systemic Fungicide Active Constituent/s: 200g/L Phosphorous Acid present as Mono-Di Potassium Phosphite. Applicant Name: Accensi Pty Ltd Applicant ACN: 079 875 184 Summary of Use: For the control of root rot, collar rot, downy mildew for citrus, avocadoes, grapes and
ornamentals. Date of Registration: 20 April 2011 Label Approval No: 65828/52122
Product Name: Amgrow Fruit Fly Control Active Constituent/s: 0.24g/L Spinosad. Applicant Name: Amgrow Pty Ltd Applicant ACN: 100 684 786 Summary of Use: For control of fruit flies on fruit and vegetables in the home garden. Date of Registration: 20 April 2011 Label Approval No: 66030/52545
Product Name: Atlas Pantry Moth Trap Active Constituent/s: 4.9g/kg (Z,E)-9,12-tetradecadien-1-yl acetate Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: For use in pantries to control Indian Meal Moth, Almond Moth and Raisin Moth. Date of Registration: 20 April 2011 Label Approval No: 65974/52424
Product Name: Hombre Ultra Cereal Seed Treatment Active Constituent/s: 360g/L Imidacloprid, 12.5g/L Tebuconazole. Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: For the control of various pests and diseases in cereal crops. Date of Registration: 28 April 2011 Label Approval No: 65040/49942
Product Name: Zorro Ultra Cereal Seed Treatment Active Constituent/s: 360g/L imidacloprid, 112g/L triadimenol Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: Flowable concentrate seed treatment for the control of various insects and fungal diseases in
cereal crops. Date of Registration: 21 April 2011 Label Approval No: 65031/49933
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 7
Product Name: Imtrade Bifenthrin Ultra 400 EC Termiticide & Insecticide Active Constituent/s: 100g/L n-methyl-2-pyrrolidone, 400g/L bifenthrin, 426g/L hydrocarbon liquid Applicant Name: Imtrade Australia Pty Ltd Applicant ACN: 090 151 134 Summary of Use: For the pre and post construction management of subterranean termites and for the control
of a range of urban pests and for the protection of timber and timber-based product from damage by borers and termites.
Date of Registration: 27 April 2011 Label Approval No: 65402/50844
Product Name: Crop Care Vivando Fungicide Active Constituent/s: 500g/L metrafenone Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Use: For use in cucurbits and grapevines for the control of powdery mildew. Date of Registration: 28 April 2011 Label Approval No: 66118/52764
Product Name: Freestyle Premium Pool Products Triple Action Chlorine Active Constituent/s: 560g/kg chlorine present as sodium dichloroisocyanurate dihydrate Applicant Name: Pool Resources Pty Limited Applicant ACN: 062 201 441 Summary of Use: For control of algae and bacteria in swimming pools. Date of Registration: 29 April 2011 Label Approval No: 65944/52369
Product Name: Supremo 450 Herbicide Active Constituent/s: 450g/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 broad range of annual and perennial weeds in various situations. Date of Registration: 29 April 2011 Label Approval No: 66039/52574
Product Name: Enviromax Bifenthrin 250 EC Insecticide & Miticide Active Constituent/s: 250g/L Bifenthrin. Applicant Name: Enviromax Technologies Pty Ltd Applicant ACN: 132 643 577 Summary of Use: For the control of insect pests and mites of apricots, bananas, barley, canola, citrus, clover,
faba beans, field peas, grapes, lucerne, lucerne seed crops, lupins, navy beans, nectarines, peaches, pears, plums, subterranean clover, sugarcane, tomatoes and wheat.
Date of Registration: 29 April 2011 Label Approval No: 65395/50827
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 8
Product Name: Omni Spa Sanitising Granules Sanitiser & Oxidiser Active Constituent/s: 150g/kg sodium bromide, 530g/kg chlorine present as sodium dichloroisocyanurate Applicant Name: Chemtura Australia Pty Ltd Applicant ACN: 005 225 507 Summary of Use: For use in outdoor spas to control algae and bacteria. Date of Registration: 29 April 2011 Label Approval No: 66018/52485
Product Name: Omni Spa Spa Shock Oxidiser Active Constituent/s: 372g/kg chlorine present as sodium dichloroisocyanurate Applicant Name: Chemtura Australia Pty Ltd Applicant ACN: 005 225 507 Summary of Use: For oxidising spa water. Date of Registration: 2 May 2011 Label Approval No: 66260/53094
Product Name: Agrismart Tri-Allate 500 Herbicide Active Constituent/s: 500g/L Triallate. Applicant Name: Goobang Pty Ltd Applicant ACN: 091 240 265 Summary of Use: For the control of wild oats in a range of crops. Date of Registration: 2 May 2011 Label Approval No: 64581/50393
Product Name: Opal Liquid Ammonium Sulfate Adjuvant Active Constituent/s: 417g/L ammonium sulphate Applicant Name: Opal Australasia Pty Ltd Applicant ACN: 103 454 879 Summary of Use: For use as an adjuvant with glyphosate based herbicides to minimise antagonism when tank
mixing with flowable herbicides and to improve performance under adverse environmental conditions as per with directions for use.
Date of Registration: 3 May 2011 Label Approval No: 65735/51730
Product Name: Nufarm Flight EC Herbicide Active Constituent/s: 210g/L Bromoxynil present as the N-Octanoyl Ester, 350g/L MCPA present as the Ethyl
Hexyl Ester, 35g/L Picolinafen. Applicant Name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of Use: For the control of certain broadleaf weeds including wild radish in winter cereals. Date of Registration: 4 May 2011 Label Approval No: 65242/50503
Product Name: AgNova Fongarid 250 WP Systemic Fungicide Active Constituent/s: 250g/kg furalaxyl Applicant Name: AgNova Technologies Pty Ltd Applicant ACN: 097 705 158 Summary of Use: For control of damping off and root rot diseases in home garden situations. Date of Registration: 4 May 2011 Label Approval No: 66210/52997
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 9
Product Name: Arysta Select Xtra Herbicide Active Constituent/s: 360g/L clethodim Applicant Name: Arysta Lifescience North America Corporation Applicant ACN: N/A Summary of Use: Herbicide for the control of certain grass weeds in pulse crops, pasture legume, cotton and
forestry. Date of Registration: 4 May 2011 Label Approval No: 65513/51084
Product Name: Detia Gas Ex B Fumigation Blankets Active Constituent/s: 330g/kg phosphine (ph3) present as aluminium phosphide Applicant Name: Detia Degesch GmbH Applicant ACN: N/A Summary of Use: Aluminium Phosphide product for use as a fumigant for the control of stored product pests in
stored commodities and well sealed empty structures such as mills and warehouses. Date of Registration: 4 May 2011 Label Approval No: 63587/45988
Product Name: Contax Summer Oil Insecticide Active Constituent/s: 825g/L petroleum oil Applicant Name: Victorian Chemical Company Proprietary Limited Applicant ACN: 004 188 863 Summary of Use: For the control of scale insects on citrus, mites on pome and stone fruit and cercospora,
cordana, leaf spots and leaf speckle on bananas and for use as a spreader. Date of Registration: 5 May 2011 Label Approval No: 66157/52884
2. VARIATIONS
Product Name: Imtrade Whack 720 Fungicide Applicant Name: Imtrade Australia Pty Ltd Applicant ACN: 090 151 134 Summary of Variation: To product name from WHACK FUNGICIDE to IMTRADE WHACK 720 FUNGICIDE and
RLP's (Fungicide Group) Date of Variation: 18 April 2011 Label Approval No: 53613/53227
Product Name: Titan Procymidone 500 Fungicide Applicant Name: Titan Ag Pty Ltd Applicant ACN: 122 081 574 Summary of Variation: To include use on canola and lentils. Date of Variation: 20 April 2011 Label Approval No: 65892/52791
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 10
Product Name: Solfac Pro Residual Insecticide Applicant Name: Bayer CropScience Pty Ltd Applicant ACN: 000 226 022 Summary of Variation: To add uses from closely similar product. Date of Variation: 19 April 2011 Label Approval No: 59424/52555
Product Name: Precept 300 EC Selective Herbicide Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Variation: To include control of bedstraw, volunteer lentil, paterson's curse and yellow burrweed,
addition of critical comments, new recropping instructions and new compatability statements. Date of Variation: 21 April 2011 Label Approval No: 62652/48977
Product Name: Imtrade Mancozeb 800 WP Fungicide Applicant Name: Imtrade Australia Pty Ltd Applicant ACN: 090 151 134 Summary of Variation: To change product name from CHEMFARM MANCOZEB 800 WP FUNGICIDE to IMTRADE
MANCOZEB 800 WP FUNGICIDE Date of Variation: 21 April 2011 Label Approval No: 57749/53230
Product Name: Crop Care Stomp Xtra Herbicide Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Variation: To extend the uses to include, lucerne, pyrethrum and turf. Date of Variation: 21 April 2011 Label Approval No: 58924/52690
Product Name: Crusader Herbicide Applicant Name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of Variation: Variation of registration and label approval to extend the use to add additional weed species
(deadnettle and small flowered mallow) and alter tank mix rate for MCPA. Date of Variation: 27 April 2011 Label Approval No: 61277/51143
Product Name: Omni Advantage Tabs Pool Sanitiser Applicant Name: Chemtura Australia Pty Ltd Applicant ACN: 005 225 507 Summary of Variation: To change the product name from GUARDEX POOL SANITISER ADVANTAGE TABS to
OMNI ADVANTAGE TABS POOL SANITISER and change pack size to range (1.6-12.8kg). Date of Variation: 28 April 2011 Label Approval No: 53367/50063
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 11
Product Name: Imtrade Dazomet 980 Granular Fumigant Applicant Name: Imtrade Australia Pty Ltd Applicant ACN: 090 151 134 Summary of Variation: To change product name from IMTRADE DAZOMET 980 GRANULAR SOIL FUMIGANT to
IMTRADE DAZOMET 980 GRANULAR FUMIGANT, add uses to label, for the control of fungi and insects including termites inside wood products such as utility poles and pilings, add pack sizes and to update sites of manufacture.
Date of Variation: 27 April 2011 Label Approval No: 63823/50517
Product Name: Flutifol 250 SC Fungicide Applicant Name: United Phosphorus Ltd Applicant ACN: 066 391 384 Summary of Variation: Variation to product to change name from 'United Phosphorus Flutriafol 250 SC Fungicide' to
'Flutifol 250 SC Fungicide' Date of Variation: 3 May 2011 Label Approval No: 65007/53478
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 12
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.
3. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Clear Cough Oral Decongestant For Horses Active Constituent/s: 27mL/L Squill - Liquid Extract, 20g/L Potassium Iodide, 20g/L Ammonium Chloride. Applicant Name: Medivet Pty Ltd Applicant ACN: 130 317 010 Summary of Use: An aid in the treatment of coughing and other clinical signs associated with respiratory
infections in horses. Date of Registration: 19 April 2011 Label Approval No: 64871/49499
Product Name: Vital Cyromazine Spray-On Sheep Blowfly Treatment Active Constituent/s: 60g/L Cyromazine. Applicant Name: Langey Holdings Pty Ltd Applicant ACN: 003 352 529 Summary of Use: For the protection of long wool sheep against fly strike for eleven weeks Date of Registration: 19 April 2011 Label Approval No: 66034/52560
Product Name: Cartrophen Equine Active Constituent/s: 100mg/mL pentosan polysulfate sodium Applicant Name: Biopharm Australia Pty Ltd Applicant ACN: 003 425 803 Summary of Use: An injection to aid in the treatment of non-inflammatory joint disease in horses. Date of Registration: 20 April 2011 Label Approval No: 65191/50370
Product Name: Natugrain TS Active Constituent/s: 2500units/gm endo-1,4-ß-glucanase (EC 3.2.1.4), 5600units/gm endo-1,4-B ß -xylanase (EC
3.2.1.8) Applicant Name: BASF Australia Ltd Applicant ACN: 008 437 867 Summary of Use: For use in poultry and pigs that acts as a digestive enhancer for diets containing high levels
of non-starch polysaccharides. Date of Registration: 20 April 2011 Label Approval No: 63979/47128
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 13
Product Name: Natugrain TS L Active Constituent/s: 2500units/gm endo-1,4- ß -glucanase (ec 3.2.1.4), 5600units/gm endo-1,4- ß -xylanase (ec
3.2.1.8) Applicant Name: BASF Australia Ltd Applicant ACN: 008 437 867 Summary of Use: An enzymatic feed additive for use in poultry and pigs that acts as a digestive enhancer for
diets containing high levels of non-starch polysaccharides. Date of Registration: 21 April 2011 Label Approval No: 63980/47129
Product Name: Rhinogard Bovine Herpesvirus 1 Live Intranasal Liquid Vaccine For Feedlot Cattle Active Constituent/s: ≥104TCID50/doseBHV1 Applicant Name: Pfizer Animal Health A Div Of Pfizer Australia Pty Ltd Applicant ACN: 008 422 348 Summary of Use: As an aid in the control of bovine herpesvirus 1 infection in feedlot cattle. Date of Registration: 28 April 2011 Label Approval No: 65951/52376
Product Name: Cartrophen Equine Forte Active Constituent/s: 250mg/mL Pentosan Polysulfate Sodium. Applicant Name: Biopharm Australia Pty Ltd Applicant ACN: 003 425 803 Summary of Use: For use as an aid in the treatment of non-infectious, inflammatory joint disease in horses. Date of Registration: 29 April 2011 Label Approval No: 65177/50333
Product Name: Bob Martin Since 1892 Puppy Chocolate Dewormer Active Constituent/s: 143mg Pyrantel Embonate per square Applicant Name: Bob Martin (Australia) Pty Ltd Applicant ACN: 062 627 883 Summary of Use: To aid in the control and treatment of roundworm (toxocara canis) and hookworm
(ancylostoma canium and Uncinaria stenocephala) in puppies and dogs. Date of Registration: 2 May 2011 Label Approval No: 66063/52621
Product Name: Fresofol Vet Intravenous Anaesthetic For Dogs And Cats Active Constituent/s: 10mg/mL propofol Applicant Name: Fresenius Kabi Australia Pty Limited Applicant ACN: 109 383 593 Summary of Use: For intravenous anaesthesia in dogs and cats. Date of Registration: 2 May 2011 Label Approval No: 62816/44033
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 14
4. VARIATIONS
Product Name: Hills's Prescription Diet L/D Canine Applicant Name: Hill's Pet Nutrition Inc Applicant ACN: 003 954 550 Summary of Variation: To change name from HILL’S PRESCRIPTION DIET CANINE L/D CAN to HILL’S
PRESCRIPTION DIET L/D CANINE and variation to label approval. Date of Variation: 19 April 2011 Label Approval No: 55403/370g/0409
Product Name: Bay-O-Pet Drontal Allwormer For Medium Dogs Applicant Name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of Variation: To change product name from BAY-O-PET DRONTAL ALLWORMER FOR MEDIUM DOGS
CONTROLS ALL 11 GASTROINTESTINAL WORMS to BAY-O-PET DRONTAL ALLWORMER FOR MEDIUM DOGS and to add a claim for control of shedding of Giardia Oocystes.
Date of Variation: 20 April 2011 Label Approval No: 46213/52957
Product Name: Bay-O-Pet Drontal Allwormer For Large Dogs Applicant Name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of Variation: To change product name from BAY-O-PET DRONTAL ALLWORMER FOR LARGE DOGS
CONTROLS ALL 11 GASTROINTESTINAL WORMS to BAY-O-PET DRONTAL ALLWORMER FOR LARGE DOGS and to add claim for control of shedding of Giardia Oocysts.
Date of Variation: 20 April 2011 Label Approval No: 46219/52958
Product Name: Bay-O-Pet Drontal Allwormer Chewable For Large Dogs Applicant Name: BAYER AUSTRALIA LTD (ANIMAL HEALTH) Applicant ACN: 000 138 714 Summary of Variation: To change product name from BAY-O-PET DRONTAL ALLWORMER CHEWABLE FOR
LARGE DOGS CONTROLS ALL 11 GASTROINTESTINAL WORMS to BAY-O-PET DRONTAL ALLWORMER CHEWABLE FOR LARGE DOGS and to add claim for control of Giardia Oocysts.
Date of Variation: 21 April 2011 Label Approval No: 59289/52959
Product Name: Bay-O-Pet Drontal Allwormer Chewable For Dogs Applicant Name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of Variation: To change product name from BAY-O-PET DRONTAL ALLWORMER CHEWABLE FOR
DOGS CONTROLS ALL 11 GASTROINTESTINAL WORMS to BAY-O-PET DRONTAL ALLWORMER CHEWABLE FOR DOGS and add claim for control of shedding of Giardia Oocystes.
Date of Variation: 21 April 2011 Label Approval No: 59292/52960
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 15
Product Name: Bay-O-Pet Drontal Allwormer For Small Dogs And Puppies Applicant Name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of Variation: To change product name from BAY-O-PET DRONTAL ALLWORMER FOR SMALL DOGS
AND PUPPIES CONTROLS ALL 11 GASTROINTESTINAL WORMS to BAY-O-PET DRONTAL ALLWORMER FOR SMALL DOGS AND PUPPIES and add claim for control of shredding of Giardia Oocysts.
Date of Variation: 21 April 2011 Label Approval No: 46214/52956
Product Name: Cerenia 160mg Tablets For Dogs Applicant Name: Pfizer Animal Health A Div Of Pfizer Australia Pty Ltd Applicant ACN: 008 422 348 Summary of Variation: Variation to registration and label approval to add a claim for the prevention of nausea. Date of Variation: 28 April 2011 Label Approval No: 62421/50739
Product Name: Cerenia 60mg Tablets For Dogs Applicant Name: Pfizer Animal Health A Div Of Pfizer Australia Pty Ltd Applicant ACN: 008 422 348 Summary of Variation: Variation to registration and label approval to add a claim for the prevention of nausea. Date of Variation: 28 April 2011 Label Approval No: 62422/50741
Product Name: Cerenia 24mg Tablets For Dogs Applicant Name: Pfizer Animal Health A Div Of Pfizer Australia Pty Ltd Applicant ACN: 008 422 348 Summary of Variation: Variation to registration and label approval to add claim for the prevention of nausea. Date of Variation: 28 April 2011 Label Approval No: 62423/50742
Product Name: Cerenia 16mg Tablets For Dogs Applicant Name: Pfizer Animal Health A Div Of Pfizer Australia Pty Ltd Applicant ACN: 008 422 348 Summary of Variation: Variation to registration and label approval to add a claim for the prevention of nausea. Date of Variation: 28 April 2011 Label Approval No: 62424/50740
Product Name: Elanco AF1404 Rumensin 100 Monensin Sodium Applicant Name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd Applicant ACN: 000 233 992 Summary of Variation: Approval of the extension of use in sheep for the prevention of ovine coccidiosis and for
improved weight gain and feed efficiency. Date of Variation: 28 April 2011 Label Approval No: 47359/41873
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 16
Product Name: Prednoderm Dermal Ointment Applicant Name: Jurox Pty Limited Applicant ACN: 000 932 230 Summary of Variation: Variation to registration and label approval to change the trade name from VR Prednoderm
Dermal Ointment to Prednoderm Dermal Ointment. Date of Variation: 3 May 2011 Label Approval No: 36186/53221
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 17
OTHER NOTICES
Preliminary Review Findings Related to Approvals and Registrations of Carbendazim
Carbendazim is a systemic benzimidazole fungicide used to control a range of fungal diseases on pulses, fruits, macadamia nuts, cucurbits, pastures, roses, timber and turf, as well as post-harvest treatment of fruits. The APVMA acted in January 2010 to prohibit the use of carbendazim on turf, grapes, citrus, custard apples, mangoes, cucurbits, pome fruits and stone fruit. Carbendazim products are not registered for home garden use.
The APVMA reviewed aspects of active constituent approvals, product registrations and label approvals for carbendazim, in accordance with Part 2, Division 4, of the Agvet Codes.
The review of carbendazim and thiophanate-methyl commenced in February 2007 and addressed public health, occupational health and safety and residues in food concerns. The APVMA also considered whether product labels carry adequate instructions and warning statements.
Following the completion of the assessment of data for the review of carbendazim, the APVMA has found it necessary to mitigate the risks arising from exposure to carbendazim by changing the instructions on labels and deleting a number of uses. The APVMA is satisfied that the use of products containing carbendazim in accordance with proposed amended label instructions would not be likely to have a harmful effect on human health.
In view of these findings, the APVMA proposes to take the following regulatory actions. It should be noted that those label changes annotated below as implemented January 2010 have already been included on labels or included as additional instructions affixed to product containers:
a) Affirm active constituent approvals (Table 1)
b) To satisfy the requirements for continued registration of products, vary the most recent label approval (as marked in Table 2) as follows:
a. Signal heading and storage instructions appropriate for Schedule 7 are to be included in all labels (implemented Jan 2010)
b. Amendment of the safety directions to include:
i. The statements “Very dangerous, particularly the concentrate” and “Poisonous if absorbed by skin contact, inhaled or swallowed”;
ii. the use of a face shield when mixing and loading 80 - 500 g/L SC products;
iii. The use of a full facepiece respirator (with dust cartridge or canister) when mixing and loading wettable powder products; and
iv. Additional instructions ‘Will damage the eyes and skin’ for the 75 g/L timber protection product.
c. Instructions for treatment of turf are to be deleted from labels due to potentially unacceptable risks to the public (implemented Jan 2010)
d. Instructions for use on grapes, citrus, custard apples and mangoes, cucurbits (including melons), pome fruits and stone fruit are to be deleted from labels due to potentially unacceptable dietary risks to humans (implemented Jan 2010)
Other Notices - Preliminary Review Findings Related to Approvals and Registrations of Carbendazim
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 18
e. The label warning statements regarding birth defects (added to labels in May 2007 as an interim action of this review) are to be extended to include male infertility as follows: "Contains carbendazim which causes birth defects and (irreversible) male infertility in laboratory animals. Avoid contact with carbendazim" (Implemented Jan 2010)
f. Instructions for use on bananas, strawberries, ginger seed pieces, sugar cane setts, pasture, red clover and subterranean clover are to be deleted from labels at the time of finalisation of the review because of a lack of data to assess residue concerns,
g. Instructions for use on roses are to be deleted from labels because of OHS concerns
c) If the proposed label variations are made then the product registrations and label approvals of the products listed in Table 2 can be affirmed.
d) Cancel product label approvals.The APVMA is not satisfied that the label instructions on previously approved labels of carbendazim products meet the requirements for continued registration of carbendazim as they do not include current safety directions and warnings and include use patterns that are not acceptable. Therefore, it proposes to cancel all previous label approvals for carbendazim as noted in Table 2.
The APVMA’s detailed findings can be found in the APVMA’s Carbendazim Preliminary Review Findings Report, available on the APVMA website, http://www.apvma.gov.au.
MAKING A SUBMISSION
The APVMA invites persons and organisations to submit their comments and suggestions on this Preliminary Review Findings document directly to the APVMA. These comments will assist the APVMA in preparing the Final Review Report and Regulatory Decision. Submissions specifically addressing the areas of concern noted in the Preliminary Review Findings report must be in writing and reach the APVMA by 05 August 2011.
Please note that subject to the Freedom of Information Act 1982, the Privacy Act 1988 and the Agvet Codes all submissions received may be made publicly available. They may be listed or referred to in any papers or reports prepared on this subject matter.
The APVMA reserves the right to reveal the identity of a respondent unless a request for anonymity accompanies the submission. If no request for anonymity is made, the respondent will be taken to have consented to the disclosure of their identity for the purposes of Information Privacy Principle 11 of the Privacy Act 1988.
The contents of any submission will not be treated as confidential or confidential commercial information unless they are marked as such and the respondent has provided justification such that the material is capable of being classified as confidential or confidential commercial information in accordance with the Freedom of Information Act 1982 or the Agvet Codes as the case may be.
When making a submission please include:
• Contact name • Company or Group name (if relevant) • Postal Address • Email Address (if available) • The date you made the submission.
Other Notices - Preliminary Review Findings Related to Approvals and Registrations of Carbendazim
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 19
Written submissions specifically addressing the areas of concern noted in the Preliminary Review Findings report should be addressed in writing to:
Manager Chemical Review Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4700 Fax: (02) 6210 4776 Email: [email protected]
Other Notices - Preliminary Review Findings Related to Approvals and Registrations of Carbendazim
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 20
Table 1: Active constituent approvals for carbendazim
Approval No. Approval Holder
44446 4Farmers Pty Ltd
52717 Colin Campbell (Chemicals) Pty Ltd
52720 Farmoz Pty Limited
55520 Imtrade Australia Pty Ltd
58049 Redox Pty Ltd
58228 Sinon Australia Pty Limited
61982 Sinon Australia Pty Limited
64891 Agpro IP Co. Pty Ltd
Table 2: Registered products containing carbendazim
Product No. Product Name Registrant Label Approval No.
30740 Hylite Timber Preservative Osmose Australia Pty Ltd 30740/0799 to be cancelled 30740/0500 to be cancelled 30740/1100 to be varied
50528 4Farmers Carbendazim 500 Fungicide WP
4Farmers Pty Ltd 50528/0599 to be varied
52878 Farmoz Howzat SC Systemic Fungicide
Farmoz Pty Limited 52878/0600 to be cancelled 52878/0202 to be cancelled 52878/0906 to be varied 52878/1005 to be cancelled 52878/1204 to be cancelled
53061 Boomer Systemic Fungicide Sipcam Pacific Australia Pty Ltd 53061/0600 to be cancelled 53061/0505 to be varied
53390 Chemag Carbendazim 500 SC Fungicide
Imtrade Australia Pty Ltd 53390/0101 to be cancelled 53390/0203 to be varied
54167 Kendon Carbendazim SC Systemic Fungicide
Kendon Plant Care Pty Ltd 54167/1201 to be varied
56692 Superway Carbendazim 500 Systemic Fungicide
Superway Garden Ag & Pest Products Pty Ltd
56692/0703 to be varied
56783 Halley Carbendazim 500 Systemic Fungicide
Halley International Enterprise (Australia) Pty Ltd
56783/0103 to be varied
59434 Shincar 500 SC Fungicide Sinon Australia Pty Limited 59434/0905 to be varied
59815 Nufarm Spin Flo Systemic Fungicide
Nufarm Australia Limited 59815/0705 to be cancelled 59815/1105 to be varied
61334 ¥ 4Farmers Carbendazim 500 SC Fungicide 4 Farmers Pty Ltd 61334/0907 to be varied
63167 ¥ Country Carbendazim 500 Fungicide Accensi Pty Ltd 63167/0808 to be varied
Other Notices - Preliminary Review Findings Related to Approvals and Registrations of Carbendazim
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 21
Product No. Product Name Registrant Label Approval No.
64490 ¥ Carazim 500 Fungicide Hextar Chemicals Pty Ltd 64490/1009 to be cancelled 64490/51141 to be varied
65561 ¥ Masmart Carbendazim Systemic Fungicide Masmart Pty Ltd 65561/51293 to be varied
66094 ¥ Sumitomo Motac 500 SC Fungicide
Sumitomo Chemical Australia Pty Limited 66094/52713 to be varied
¥ Product registered after commencement of the review but registration conditional on the outcomes of the review.
Other Notices - Preliminary Review Findings Related to Approvals and Registrations of Carbendazim
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 22
Amendments to the APVMA MRL Standard
The Australian Pesticides and Veterinary Medicines Authority (APVMA) approves maximum residue limits (MRLs) of agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. The MRLs approved by the APVMA are associated with a regulatory decision to register a product, grant a permit approval, or as an outcome from a review decision and are set out in the MRL Standard published by the APVMA. The MRL Standard lists MRLs of substances which may arise from the approved use of agricultural and veterinary chemical products containing those substances on commodities used for human consumption as well as livestock feeds. The MRL Standard also provides the relevant residue definitions to which these MRLs apply. There may be situations where the residue definition for monitoring and enforcement is different to the definition used for dietary risk assessment purposes.
MRLs are set at levels which are not likely to be exceeded if the agricultural or veterinary chemicals are used in accordance with approved label instructions. In considering MRLs and variation to MRLs, the APVMA takes into account studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice and dietary exposure. In approving MRLs, the APVMA is satisfied, from dietary exposure assessment, that the levels set are not an undue hazard to human health.
The MRL Standard is accessible via the APVMA website, www.apvma.gov.au
The APVMA has varied the MRL Standard as set out below with effect from the date of this notice.
For further information please contact:
Residues Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4837 Fax: (02) 6210 4840
Email: [email protected]
Other Notices - Amendments to the APVMA MRL Standard
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 23
AMENDMENT No. 11N, 2011
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.
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)
Dimethenamid-P
ADD:
SO 0495 Rape seed [canola] T*0.01
Methomyl
DELETE:
Chia T0.5
ADD:
Chia T1
Monensin
ADD:
MF 0822 Sheep fat 0.07
MO 1288 Sheep, kidney 0.015
MO 1289 Sheep, liver 0.2
Sheep muscle 0.005
Other Notices - Amendments to the APVMA MRL Standard
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 24
COMPOUND FOOD MRL (mg/kg)
Propachlor
ADD:
VL 0464 Chard [silver beet] T*0.02
VL 0502 Spinach T*0.02
Propyzamide
ADD:
SO 0698 Poppy seed T*0.02
Prothioconazole
ADD:
SO 0495 Rape seed [canola] T*0.02
Spinetoram
DELETE:
MM 0095 Meat (mammalian)[in the fat] *0.01
FM 0183 Milk fats *0.01
ADD:
FI 0030 Assorted tropical and sub-tropical fruits - inedible peel 0.3
FB 0018 Berries and other small fruits 0.5
VB 0040 Brassica (cole or cabbage) vegetables, Head cabbages, Flowerhead brassicas
0.2
FC 0001 Citrus fruits 0.2
SB 0716 Coffee beans *0.01
Coriander (leaves, roots and stems) 5
HS 0779 Coriander, seed 5
HS 0730 Dill seed 5
DF 0269 Dried grapes (= currants, Raisins and Sultanas) 1
HS 0731 Fennel, seed 5
VC 0045 Fruiting vegetables, Cucurbits 0.05
VO 0050 Fruiting vegetables, other than Cucurbits [except sweet corn] 0.1
Other Notices - Amendments to the APVMA MRL Standard
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 25
COMPOUND FOOD MRL (mg/kg)
HH 0092 Herbs 1
Kaffir lime leaves 5
VL 0053 Leafy vegetables 0.7
VP 0060 Legume vegetables 0.2
Lemon grass 5
DT 1111 Lemon verbena (dry leaves) 5
MM 0095 Meat (mammalian) [in the fat] 0.05
FM 0183 Milk fats 0.02
Mizuna 0.7
VR 0075 Root and tuber vegetables 0.02
VS 0078 Stalk and stem vegetables 2
HS 0794 Turmeric, root 0.02
Spirotetramat
DELETE:
MO 0105 Edible offal (Mammalian) 0.05
VO 0050 Fruiting vegetables, other than Cucurbits 7
VL 0053 Leafy vegetables [except Lettuce, Head] 5
VP 0060 Legume vegetables T2
MM 0095 Meat (mammalian) *0.01
ADD:
VL 0054 Brassica leafy vegetables 10
MO 0105 Edible offal (Mammalian) 0.5
VO 0050 Fruiting vegetables, other than Cucurbits [except sweet corn (corn-on-the-cob)]
7
VL 0053 Leafy vegetables [except Lettuce, Head; Brassica leafy vegetables]
5
VP 0060 Legume vegetables 2
MM 0095 Meat (mammalian) 0.02
VO 0447 Sweet corn (corn-on-the-cob) 1
Other Notices - Amendments to the APVMA MRL Standard
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 26
COMPOUND FOOD MRL (mg/kg)
Tebuconazole
ADD:
SO 0495 Rape seed [canola] T0.3
Thiodicarb
ADD:
Chia T0.5
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)
Dimethenamid-P
DELETE:
AL 0061 Bean fodder *0.02
AL 1030 Bean forage (green) *0.02
Forage and fodder of pulses *0.02
AL 0072 Pea hay or Pea fodder (dry) *0.02
AL 0528 Pea vines (green) *0.02
ADD:
AL 0157 Legume animal feeds 0.07
Rape seed [canola] forage, fodder and straw [fresh weight] T*0.01
ADD:
Piperonyl butoxide
Cotton seed meal T*0.05
Prothioconazole
ADD:
Rape seed [canola] forage, fodder and straw T2
Other Notices - Amendments to the APVMA MRL Standard
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 27
COMPOUND ANIMAL FEED COMMODITY MRL (mg/kg)
ADD:
Pyrethrins
Cotton seed meal T*0.05
Spinetoram
ADD:
AB 0001 Citrus pulp, dry 0.2
AB 0269 Grape pomace, dry 2
AL 0157 Legume animal feeds 1
Tomato pomace, dry 1
Spirotetramat
ADD:
AL 0157 Legume animal feeds 20
Sweet corn forage and fodder 5
Other Notices - Amendments to the APVMA MRL Standard
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 28
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
In the previous notice, the APVMA gazetted particular amendments which it has approved varying maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in the APVMA’s MRL Standard.
Under Section 82 of the Food Standards Australia New Zealand Act 1991 the APVMA is proposing to incorporate these variations 11N to MRLs into Standard 1.4.2 - Maximum Residue Limits of the Australia New Zealand Food Standards Code. Details of the gazettal of these earlier variations are available from the APVMA (see contact details at the end of this notice).
MRLs contained in Standard 1.4.2 provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this means, Standard 1.4.2 permits the sale of treated foods and protects public health and safety by minimising residues in foods consistent with the effective control of pests and diseases.
The APVMA is satisfied that dietary exposure assessments indicate that in relation to current reference health standards, setting the MRLs as proposed does not present any public health and safety concern.
The Agreement between the Government of Australia and the Government of New Zealand concerning a Joint Food Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.
Food Standards Australia New Zealand (FSANZ) will make a Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO).
The APVMA invites comment on these proposals. Details on how to make a submission appear near the end of this Notice below the details of the proposed amendment.
The APVMA will consider any public comments made in response to this proposal. If the APVMA decides to proceed with the proposal, it will further notify any variations it makes to Standard 1.4.2 in the APVMA Gazette. The variations will take effect as from the date of that subsequent notice.
Other Notices - Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 29
DRAFT VARIATIONS TO THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE
Note: The following amendments are in a format that accords with the proposed amending Legislative Instrument which, in turn, has to be consistent with the existing format of Standard 1.4.2 (Maximum Residue Limits) of the Australia New Zealand Food Standards Code.
PROPOSED AMENDMENT NO. 11N
Note: Subsection 82(2) of the Food Standards Australia New Zealand Act 1991 provides that variations to standards are legislative instruments, but are not subject to disallowance or sunsetting.
To commence: on gazettal of variation [1] Standard 1.4.2 of the Australia New Zealand Food Standards Code is varied by – [1.1] omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –
Spirotetramat Sum of spirotetramat, and cis-3-(2,5-
dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, expressed as
spirotetramat Fruiting vegetables, other than
cucurbits 7
Leafy vegetables [except lettuce, head]
5
[1.2] inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals –
Dimethenamid-P Sum of dimethenamid-P and its (R)-isomer
Rape seed (canola) T*0.01
Monensin Monensin
Sheep fat 0.07Sheep kidney 0.015Sheep liver 0.2Sheep muscle 0.005
Propachlor Sum of propachlor and metabolites hydrolysable to
N-isopropylaniline, expressed as propachlor Chard (silver beet) T*0.02Spinach T*0.02
Propyzamide Propyzamide
Poppy seed T*0.02
Other Notices - Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 30
Prothioconazole Commodities of plant origin: Sum of prothioconazole
and prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-
triazol-1-yl)-propan-2-ol), expressed as prothioconazole
Commodities of animal origin: Sum of prothioconazole, prothioconazole desthio (2-(1-
chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxy-
desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-3-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol)
and prothioconazole-4-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-4-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as
prothioconazole Rape seed (canola) T*0.02
Spinetoram Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L
Assorted tropical and sub-tropical fruits - inedible peel
0.3
Berries and other small fruits 0.5Brassica (cole or cabbage)
vegetables, Head cabbages, Flowerhead brassicas
0.2
Citrus fruits 0.2Coffee beans *0.01Coriander (leaves, stem, roots) 5Coriander, seed 5Dill, seed 5Dried grapes (currants, raisins and
sultanas) 1
Fennel, seed 5Fruiting vegetables, cucurbits 0.05Fruiting vegetables, other than
cucurbits [except sweet corn (corn-on-the-cob)]
0.1
Herbs 1Kaffir lime leaves 5Leafy vegetables 0.7Legume vegetables 0.2Lemon grass 5Lemon verbena (dry leaves) 5Mizuna 0.7Root and tuber vegetables 0.02Stalk and stem vegetables 2Turmeric, root 0.02
Spirotetramat Sum of spirotetramat, and cis-3-(2,5-
dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, expressed as
spirotetramat Brassica leafy vegetables 10Fruiting vegetables, other than
cucurbits [except sweet corn (corn-on-the-cob)]
7
Leafy vegetables [except lettuce, head; brassica leafy vegetables]
5
Sweet corn (corn-on-the-cob) 1
Other Notices - Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 31
Tebuconazole Tebuconazole
Rape seed (canola) T0.3
Thiodicarb
Sum of thiodicarb, methomyl and methomyloxime, expressed as thiodicarb
see also Methomyl Chia T0.5
[1.3] omitting from Schedule 1, under the entries for the following chemicals, the maximum residue limit for the food, substituting –
Methomyl Sum of methomyl and methyl hydroxythioacetimidate
(‘methomyl oxime’), expressed as methomyl see also thiodicarb
Chia T1
Spinetoram Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L
Meat (mammalian) (in the fat) 0.05Milk fats 0.02
Spirotetramat Sum of spirotetramat, and cis-3-(2,5-
dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, expressed as
spirotetramat Edible offal (mammalian) 0.5Legume vegetables 2Meat (mammalian) 0.02
INVITATION FOR SUBMISSIONS
Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the proposal to vary Standard 1.4.2 (Maximum Residue Limits) of the Australia New Zealand Food Standards Code. Submissions should be strictly confined to relevant matters that the APVMA must consider (such as public health and safety) which are associated with the occurrence of the proposed residues in foods. Comments received outside these grounds will not be considered by the APVMA. Claims made in submissions should be supported wherever possible by referencing or including relevant studies, research findings, trials, surveys etc. Technical information should be in sufficient detail to allow independent scientific assessment.
Please note that FSANZ will make a SPS notification to the WTO and submissions related to impacts on international trade should be made to FSANZ in response to that notification.
Other Notices - Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 32
All personal and confidential commercial information (CCI)1 material contained in submissions to the APVMA will be treated confidentially.
Submissions must be made in writing and should be clearly marked as a ‘submission on the proposed amendment to Standard 1.4.2’ and quote the correct amendment number.
DEADLINE FOR PUBLIC SUBMISSIONS: 6pm (Canberra time) 7 June 2011 SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL ONLY BE CONSIDERED BY PRIOR ARRANGEMENT
Submissions received after this date will only be considered if agreement for an extension has been given prior to this closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to the submission period.
For further information please contact:
Residues Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4837 Fax: (02) 6210 4840
Email: [email protected]
1 A full definition of "confidential commercial information" is contained in the Agricultural and Veterinary Chemicals Code (Agvet Code), which is scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.
Other Notices - Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 33
Addendum to the Record of Approved Active Constituents
The current Record of Approved Active Constituents for Registered Chemical Products is also accessible from the APVMA website, www.apvma.gov.au
APPROVED SINCE GAZETTE NO. 7, APRIL 2011
For use in agricultural and/or veterinary chemical products:
Common Name Approval Holder Manufacturer Site Approval No.
Sulfosulfuron MONSANTO AUSTRALIA LTD
SUMITOMO CHEMICAL CO LTD HIKARI PLANT 4720 TAKEDA MITSUI HIKARI YAMAGUCHI 743 8502
JAPAN
44058
Pendimethalin IMTRADE AUSTRALIA PTY LTD
GSP CROPSCIENCE PRIVATE LIMITED PLOT NO 100-103, G.V.M.M. INDUSTRIAL ESTATE ODHAV AHMEDABAD GUJARAT 382410
INDIA
65343
Chlorpyrifos LANDMARK OPERATIONS LIMITED
JIANGSU FENGSHAN GROUP CO LTD
CAOMIAO TOWNDAFENG CITYJIANGSU PROVINCEPR CHINA
65331
Glufosinate-ammonium YONGNONG BIOSCIENCES CO., LTD
LANTIAN YONGQIANG WENZHOU CITY ZHEJIANG PROVINCE
PR CHINA
64779
Beta-cyfluthrin SUNDEW SOLUTIONS PTY LTD
JIANGSU YANGNONG CHEMICAL CO. LTD 39 WENFENG RD YANGZHOU JIANGSU 225009
PR CHINA
64264
Terbutryn AGPRO IP CO. PTY LTD
SHANDONG WEIFANG RAINBOW CHEMICAL CO LTD 1 HAIGANG ROAD, BINHAI ECONOMIC DEVELOPMENT AREA WEIFANG, SHANDONG
CHINA
65152
Propyzamide AGROSHINE LTD NANTONG JIAHE CHEMICALS CO LTD QINGLONGGANG CHEMICAL DISTRICT HAIMEN 226121 JIANGSU PROVINCE
CHINA
65202
Other Notices - Addendum to the Record of Approved Active Constituents
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 34
APVMA CONTACT
For further information please contact:
Application Management & Enquiries Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4701 Fax: (02) 6210 4721
Other Notices - Addendum to the Record of Approved Active Constituents
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 35
Application Summaries
The APVMA publishes complete application summaries on the APVMA website, www.apvma.gov.au. 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.8, 27 APRIL 2011
Application No. Name
52978 CANYON 600 WG HERBICIDE
44444 DAVID GRAYS GRAYBATE 50 SG MOSQUITO LARVICIDE GRANULES
47244 NOT AVAILABLE
47915 MABON'S PESTBOR INDUSTRIAL WOOD PROTECTION
48984 TRINEXAPAC-ETHYL
49111 NOT AVAILABLE
50870 INTERNATIONAL BIOLUX SELF POLISHING COPOLYMER MICRON 66 ANTIFOULING
50871 INTERNATIONAL BIOLUX NEW TECHNOLOGY TRILUX 33 HARD ANTIFOULING FOR ALUMINIUM
50937 AXTRA XB 201 TPT
50952 AXTRA XB 201 L
51075 HOMEWARE PRODUCTS MOTHBALLS
51003 CSA PARAFORMALDEHYDE
51862 YATES LIQUID COPPER FUNGICIDE
52141 RAINBOW CLOPYRALID 300 SELECTIVE HERBICIDE
52157 REDOX AMMONIUM SULPHATE HERBICIDE ADJUVANT
52242 DEPOSEL SLOW RELEASE SELENIUM INJECTION FOR CATTLE AND SHEEP
52313 VITRA 400 WG FUNGICIDE
52423 NOT AVAILABLE
52456 TWILIGHT LEMON & EUCALYPTUS MOSQUITO & FLY COILS
52646 FOSETYL-ALUMINIUM
Other Notices - Application Summaries
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 36
Application No. Name
52718 ENVIROMAX IMIDACLOPRID 200SC TURF CROP & ORNAMENTAL INSECTICIDE
52752 PERMETHRIN
52755 PACIFIC MCPA LVE 570 EC SELECTIVE HERBICIDE
52758 NOT AVAILABLE
52763 PINTOBI HERBICIDE
52765 CLOMAZONE
52789 PROGUARD DICHLOR 56 GRANULES POOL SANITISER
52875 NOT AVAILABLE
52897 NOT AVAILABLE
52931 CRESTAR FOR OESTRUS CONTROL IN BREEDING CATTLE
52944 APPARENT DIURON 500 SC HERBICIDE
52971 INTERVET NOBILIS IB VACCINE
52976 COOPERS BLOCKADE 'S' CATTLE DIP AND SPRAY
52985 NOT AVAILABLE
53038 BEAT-A-BUG POSS OFF NATURAL POSSUM DETERRENT
53184 SINMOSA 250 HERBICIDE
53191 FARMOZ AVAMIX ELITE SELECTIVE PRE-EMERGENCE HERBICIDE
53195 APPROVE SELECTIVE HERBICIDE
53198 YATES ZERO AQUA HERBICIDE
53226 CHEMAG DICHLORVOS INSECTICIDE
53233 GENFARM TRIALLATE GOLD 500 SELECTIVE HERBICIDE
52247 CREOSOTE
52459 TWILIGHT LEMON & EUCALYPTUS MOSQUITO & FLY STICKS
53174 OMNI SPA SANITISING TABLETS SANITISER
52786 HILL'S PRESCRIPTION DIET U/D CANINE
52950 HILL'S PRESCRIPTION DIET U/D CANINE
49354 METAREX SNAIL AND SLUG BAIT
49499 NOT AVAILABLE
50173 ILIUM THIOPENTONE
50487 TROY IODIN SPRAY SKIN & WOUND DRESSING
Other Notices - Application Summaries
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 37
Application No. Name
50638 PURINA TOTALCARE FLEA COLLAR FOR CATS
50649 PURINA TOTALCARE FLEA COLLAR FOR DOGS
51822 NOT AVAILABLE
52430 ATLAS MOSQUITO COILS
52435 HOVEX MOSQUITO STICKS
52449 TRICHLORFON TECHNICAL
52697 NOT AVAILABLE
52738 MACSPRED BARRIER G ORNAMENTAL HERBICIDE
52874 NOT AVAILABLE
52876 NOT AVAILABLE
52877 NOT AVAILABLE
52892 KENSO AGCARE VEL-KEN 750 WG HERBICIDE
52943 CAPSULE FOR 20-40KG SHEEP
52972 COMPANION C3 TRIVALENT LIVING VACCINE FOR DOGS
52981 NOT AVAILABLE
53007 GALA SURFACE INSECT SPRAY
53078 LONGRANGE BOTULINUM VACCINE
53349 FARMALINX TRI-ALLATE 500 EC SELECTIVE HERBICIDE
39401 HEPTAMAX BROADSPECTRUM ANTIPARASITIC INJECTION FOR CATTLE
50983 AGROREG DICAMBA 500 SELECTIVE HERBICIDE
51079 BLUE STAR ATRAZINE 900 WG HERBICIDE
51687 JUROX EPRINOMECTIN POUR-ON FOR BEEF AND DAIRY CATTLE
51766 NOT AVAILABLE
52282 NOT AVAILABLE
52415 AQUA-HEALTH POOL SHOCK POOL WATER OXIDISER
52452 TWILIGHT LAVENDAR & TEA TREE OIL MOSQUITO & FLY COILS
52458 TWILIGHT SANDALWOOD & JASMINE MOSQUITO & FLY STICKS
52460 TWILIGHT LAVENDAR & TEA TREE OIL MOSQUITO & FLY STICKS
52461 TWILIGHT ROSE & GERANIUM MOSQUITO & FLY STICKS
52462 TWILIGHT ROSE & GERANIUM MOSQUITO & FLY COILS
Other Notices - Application Summaries
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 38
Application No. Name
52464 TWILIGHT SANDALWOOD & JASMINE MOSQUITO & FLY COILS
52690 CROP CARE STOMP XTRA HERBICIDE
52764 NOT AVAILABLE
52791 TITAN PROCYMIDONE 500 FUNGICIDE
52911 PUREX POOL ALGAECIDE
52963 PROGUARD ALGAECIDE
52973 UNITED PHOSPHORUS UNISPRAY 250 HERBICIDE
52987 NOT AVAILABLE
53020
ZODIAC POWER PURIFIER TABLETS SLOW RELEASE EASY TO USE UV BLOCKOUT FOR LONG LASTING PROTECTION CONTROLS BACTERIA, VIRUSES AND ALGAE IN SWIMMING POOLS. THIS PRODUCT IS STABILISED TO INCREASE THE LONGE
53022 VALBAZEN BROAD SPECTRUM SHEEP LAMB AND GOAT DRENCH
53039 NOT AVAILABLE
53088 COUNTRY WHITE OIL RTU INSECT SPRAY
53098 NUFARM BROMICIDE MA SELECTIVE HERBICIDE
53156 METAREX SNAIL AND SLUG BAIT
53160 KDPC PROPICOL 250EC SYSTEMIC FUNGICIDE
53186 SABOTEUR SYSTEMIC INSECTICIDE
53189 NUFARM DIMETHOATE SYSTEMIC INSECTICIDE
53240 NOT AVAILABLE
53261 NOT AVAILABLE
53292 NOT AVAILABLE
53379 PIRIMOR WG APHICIDE
A change or correction has been made to the following summaries:
Application No. Product/Active Constituent Name
none
Other Notices - Application Summaries
Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 10 May 2011 Agricultural and Veterinary Chemicals Code Act 1994 39
APVMA CONTACT
For further information please contact:
Application Management and Enquiries Team (AME) Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4701 Fax: (02) 6210 4721
Other Notices - Application Summaries