apvma gazette no. 11, 8 june 2010 · 2014-09-25 · applicant acn: 130 864 603 summary of use: for...

No. APVMA 11, Tuesday, 8 June 2010 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 11, Tuesday, 8 June 2010 Agricultural and Veterinary Chemicals Code Act 1994 2

© Commonwealth of Australia 2010

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:

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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.

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For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.

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CONTENTS

Notice of Registrations 4 Agricultural Chemical Products ..............................................................................................................................................4 Veterinary Chemical Products..............................................................................................................................................11

Notice – New Veterinary Chemical Products 13 Monepantel in the product Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep ..............................................13

Other Notices 18 Licensing of Veterinary Chemical Manufacturers .................................................................................................................18 Amendments to the MRL Standard ......................................................................................................................................22 Application Summaries.........................................................................................................................................................28


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. RESTRICTED PRODUCT

No entries.

2. AGRICULTURAL PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS

No entries.

3. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: AW Announce Miticide / Insecticide Active Constituent/s: 18g/L abamectin Applicant Name: Agri West Pty Limited Applicant ACN: 108 899 181 Summary of Use: For the control of certain mites on cotton, citrus, apples, capsicums, hops, pears, tomatoes,

ornamentals and strawberries and native budworm on cotton. Date of Registration: 19 May 2010 Label Approval No: 64372/1L/0909, 64372/5L/0909, 64372/20L/0909, 64372/0909

Product Name: Agrismart Triclopyr 600 Herbicide Active Constituent/s: 600g/L triclopyr present as the butoxyethyl ester Applicant Name: Goobang Pty Ltd Applicant ACN: 091 240 265 Summary of Use: For the control of various woody and broadleaf weeds. Date of Registration: 20 May 2010 Label Approval No: 64060/5L/1109, 64060/10L/1109, 64060/20L/1109, 64060/110L/1109, 64060/200L/1109,

64060/1109

Product Name: Overture Fungicide Active Constituent/s: 125g/L epoxiconazole Applicant Name: Sipcam Pacific Australia Pty Ltd Applicant ACN: 073 176 888 Summary of Use: For the control of leaf rust, stripe rust and septoria nodorum blotch of wheat and leaf rust of

barley. Date of Registration: 24 May 2010 Label Approval No: 63994/0410, 63994/5L/0410, 63994/10L/0410, 63994/20L/0410

Notice of Registrations


Product Name: Hortiphos 600 Systemic Fungicide Active Constituent/s: 600g/L phosphorous (phosphonic) acid present as mono & di-potassium phosphonate Applicant Name: Trace Elements Supplies Pty Limited Applicant ACN: 007 419 981 Summary of Use: For use as a systemic fungicide against phytophtora disease and downy mildew in various

situations. Date of Registration: 25 May 2010 Label Approval No: 64160/20L/0310, 64160/200L/0310, 64160/1000L/0310

Product Name: Alliance Herbicide Glyphosate 450SL Active Constituent/s: 450g/L glyphosate present as the isopropylamine salt Applicant Name: Agro-Alliance (Australia) Pty Ltd Applicant ACN: 130 864 603 Summary of Use: For non-selective control of most perennial and annual weeds in conservation tillage

situations. Date of Registration: 26 May 2010 Label Approval No: 64733/0210, 64733/20L/0210

Product Name: Aqua Pure Multi-Action Jumbo Tabs Active Constituent/s: 800g/kg chlorine (CI) present as trichloroisocyanuric acid, 3g/kg available copper present as

copper sulphate pentahydrate Applicant Name: Pool Products of Australia Pty Ltd Applicant ACN: 085 385 511 Summary of Use: For control of algae and bacteria in swimming pools. Date of Registration: 26 May 2010 Label Approval No: 62895/1kg/1009, 62895/2kg/1009, 62895/10kg/1009

Product Name: Amgrow Tomato & Vegetable Dust Active Constituent/s: 10g/kg piperonyl butoxide, 880g/kg diatomaceous earth, 1g/kg pyrethrins Applicant Name: Ecofertiliser Pty Ltd Applicant ACN: 100 684 786 Summary of Use: For control of insect pests in the garden and outdoors in home garden situations. Date of Registration: 27 May 2010 Label Approval No: 64126/150G/0310, 64126/200G/0310

Product Name: Country Clopyralid 300 Selective Herbicide Active Constituent/s: 300g/L clopyralid present as the triisopropanolamine salt Applicant Name: Accensi Pty Ltd Applicant ACN: 079 875 184 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: 27 May 2010 Label Approval No: 64448/5-10L/0510, 64448/20-200L/0510, 64448/5-10LL/0510, 64448/20-200LL/0510

Product Name: Excel Sentricon AG Termite Bait Active Constituent/s: 5g/kg hexaflumuron Applicant Name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of Use: For the control of subterranean termites. Date of Registration: 27 May 2010 Label Approval No: 64761/100IP/0410, 64761/100/0410, 64761/400/0410



Product Name: Farmalinx Tripicloram 400 Herbicide Active Constituent/s: 100g/L picloram present as the hexyloxypropylamine salt, 300g/L triclopyr present as the

butoxyethyl ester Applicant Name: Farmalinx Pty Ltd Applicant ACN: 134 353 245 Summary of Use: For the control of a range of environmental and noxious woody and herbaceous weeds. Date of Registration: 27 May 2010 Label Approval No: 64324/1-5L/0809, 64324/10-1000L/0809, 64324/0809

Product Name: Country Atrazine 500 Flowable Herbicide Active Constituent/s: 500g/L atrazine Applicant Name: Accensi Pty Ltd Applicant ACN: 079 875 184 Summary of Use: For the control of annual grasses and broadleaf weeds. Date of Registration: 28 May 2010 Label Approval No: 64182/5-10L/0410, 64182/5-10LL/0410, 64182/20-1000L/0410,

64182/20-1000LL/0410

Product Name: Smasha 960 Herbicide Active Constituent/s: 960g/L metolachlor Applicant Name: Agritrading Pty Limited Applicant ACN: 134 291 295 Summary of Use: For the control of a range of annual grasses and broadleaf weeds in a range of broadacre

crops, vegetables and pasture situations. Date of Registration: 28 May 2010 Label Approval No: 64600/200L/0410, 64600/1000L/0410, 64600/0410

Product Name: Yates Buffalo Pro Bindii & Broadleaf Weed Killer Hose-On Active Constituent/s: 6g/L bromoxynil (present as potassium salt), 6g/L MCPA (present as potassium salt) Applicant Name: Duluxgroup (Australia) Pty Ltd Applicant ACN: 000 049 427 Summary of Use: For the selective control of broadleaf weeds in home garden lawns. Date of Registration: 31 May 2010 Label Approval No: 63008/2L/0510, 63008/2.4L/0510, 63008/4L/0510

Product Name: Praise 500WG Insecticide Active Constituent/s: 500g/kg buprofezin Applicant Name: Agrisource Australia Pty Ltd Applicant ACN: 107 288 344 Summary of Use: For use in citrus to control red scale, white louse scale, jassids (leafhoppers) and longtailed,

citrus and Citrophilous mealy bugs; for use in grapes and pears to control mealybugs; for use in persimmons, custard apples and passionfruit to control mealybugs and scale and for use in mangoes to control mango scale.

Date of Registration: 31 May 2010 Label Approval No: 59177/0809, 59177/500gMP/0809, 59177/1kg/0809



Product Name: AC Frenzy Herbicide Active Constituent/s: 75g/L picloram present as the triisopropanolamine salt, 300g/L 2,4-D present as the

triisopropanolamine salt Applicant Name: Agrochem Pty Ltd Applicant ACN: 131 628 594 Summary of Use: For the control of a wide range of annual and perennial broadleaf weeds. Date of Registration: 31 May 2010 Label Approval No: 64859/0210, 64859/5L/0210, 64859/20L/0210

Product Name: PCT Reactor Crop Spray Oil Active Constituent/s: 840g/L canola oil Applicant Name: PCT Holdings Pty Ltd Applicant ACN: 099 023 962 Summary of Use: For use as a spray adjuvant in agricultural spray mixes. Date of Registration: 31 May 2010 Label Approval No: 64662/1L/0410, 64662/5L/0410, 64662/20L/0410, 64662/200L/0410, 64662/1000L/0410

Product Name: 4Farmers Triadimefon 500WG Fungicide Active Constituent/s: 500g/kg triadimefon Applicant Name: 4 Farmers Pty Ltd Applicant ACN: 067 443 485 Summary of Use: For the control of fungal diseases in wheat and barley Date of Registration: 2 June 2010 Label Approval No: 64590/1kg/0110, 64590/10kg/0110, 64590/0110

Product Name: Sumi-Alpha Home Garden Insecticide Concentrate Active Constituent/s: 50g/L esfenvalerate Applicant Name: Sumitomo Chemical Australia Pty Limited Applicant ACN: 081 096 255 Summary of Use: For the control of a range of insect pests in and around domestic, public service, commercial

and industrial buildings/premises and around the home and garden on indoor and outdoor ornamental plants, flowers, shrubs, trees, non-bearing fruit trees and lawns.

Date of Registration: 3 June 2010 Label Approval No: 61383/100mL/0210, 61383/500mL/0210, 61383/1L/0210

Product Name: Sumi-Alpha Ready To Use Home Garden Insecticide Active Constituent/s: 1g/L esfenvalerate Applicant Name: Sumitomo Chemical Australia Pty Limited Applicant ACN: 081 096 255 Summary of Use: For the control of a range of insect pests in and around domestic, public service, commercial

and industrial buildings/premises and around the home and garden on indoor and outdoor ornamental plants, flowers, shrubs, trees, non-bearing fruit trees and lawns.

Date of Registration: 3 June 2010 Label Approval No: 61384/500mL/0210, 61384/750mL/0210, 61384/1L/0210, 61384/2L/0210

4. LISTED REGISTRATIONS

No entries.



5. VARIATIONS

Product Name: Nufarm Surpass 475 Herbicide Applicant Name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of Variation: To extend the use to include the control of volunteer canola including Roundup Ready

varieties in cereals and fallow situations. Date of Variation: 20 May 2010 Label Approval No: 61515/15L/0310, 61515/20L/0310, 61515/20LS/0310, 61515/110L/0310, 61515/110LS/0310,

61515/500L/0310, 61515/1000L/0310, 61515/0310

Product Name: Hussar OD Selective Herbicide Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Variation: To include control of annual ryegrass, wild oats and annual phalaris in barley. Date of Variation: 21 May 2010 Label Approval No: 61992/0410, 61992/1/0410, 61992/1L/0410, 61992/3/0410

Product Name: Nufarm Pristine Fungicide Applicant Name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of Variation: To extend the label claims to include control of black spot on pears, Alternaria (A.mali) leaf

blotch and Alternaria fruit spot on apples; to reduce the WHP for apples from 4 weeks to 14 days.

Date of Variation: 24 May 2010 Label Approval No: 62974/0410, 62974/1-10kg/0410

Product Name: Yates Lime Sulfur Insect & Disease Control Applicant Name: Duluxgroup (Australia) Pty Ltd Applicant ACN: 000 049 427 Summary of Variation: To change the product name from YATES INSECT & DISEASE CONTROL LIME SULPHUR

SPRAY to YATES LIME SULFUR INSECT & DISEASE CONTROL; copy uses from closely similar reference products; update the label lay-out and add additional formulation sites.

Date of Variation: 24 May 2010 Label Approval No: 59403/500mL/0210

Product Name: AC Quiza 99.5 EC Herbicide Applicant Name: Agrochem Pty Ltd Applicant ACN: 131 628 594 Summary of Variation: To change the product name from GEMAX QUIZALOFOP 99.5EC HERBICIDE to AC QUIZA

99.5 EC HERBICIDE; update company details on the label and add 110L pack size. Date of Variation: 24 May 2010 Label Approval No: 58770/10/1009, 58770/20/1009, 58770/110/1009, 58770/1009

Product Name: Coles Crawling Insect Killer High Performance Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Variation: To change product name from COLES CRAWLING INSECT KILLER HIGH PERFORMANCE

KILLS COCKROACHES FAST KILLS COCKROACHES FOR UP TO 6 MONTHS to COLES CRAWLING INSECT KILLER HIGH PERFORMANCE and other minor label amendments.

Date of Variation: 25 May 2010 Label Approval No: 63064/350g/0210



Product Name: Coles Flying Insect Killer Fast Knockdown Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Variation: To change product name from COLES FLYING INSECT KILLER FAST KNOCKDOWN FAST

KILL FORMULATION to COLES FLYING INSECT KILLER FAST KNOCKDOWN and other minor amendments.


Product Name: Coles Crawling Insect Killer Odourless Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Variation: To change product name from COLES CRAWLING INSECT KILLER ODOURLESS KILLS

COCKROACHES FAST DEVELOPED FOR PEOPLE WITH SENSITIVE NOSES to COLES CRAWLING INSECT KILLER ODOURLESS and other minor label amendments.


Product Name: Sumi-Alpha Flex Insecticide Applicant Name: Sumitomo Chemical Australia Pty Limited Applicant ACN: 081 096 255 Summary of Variation: To add additional formulation and to extend the use to include additional pests in existing

crops including canola, field peas, lentils, lucerne, lupins, pastures, cereal crops; the addition of the crops grapes and faba beans.

Date of Variation: 25 May 2010 Label Approval No: 53047/5L/0110, 53047/20L/0110, 53047/200L/0110, 53047/0110

Product Name: Optigard Ant Bait Gel Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 Summary of Variation: To include specific situations and identify pests by specific names on the label. Date of Variation: 27 May 2010 Label Approval No: 63523/30a/0310, 63523/30b/0310, 63523/0310

Product Name: Coles Personal Insect Repellent Spray Tropical Strength 6 Hour Protection Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Variation: To change the product name from COLES PERSONAL INSECT REPELLENT SPRAY 6

HOUR PROTECTION TROPICAL STRENGTH INSECT REPELLENT to COLES PERSONAL INSECT REPELLENT SPRAY TROPICAL STRENGTH 6 HOUR PROTECTION.


Product Name: Ospray Blackout Herbicide Applicant Name: Ospray Pty Ltd Applicant ACN: 110 199 169 Summary of Variation: To change the product name from TRADEWYNS DICAMBA M SELECTIVE HERBICIDE to

OSPRAY BLACKOUT HERBICIDE; to amend the pack sizes to 1L, 5L, 10L and 20L. Date of Variation: 2 June 2010 Label Approval No: 58442/0410, 58442/1L/0410, 58442/5L/0410, 58442/10L/0410, 58442/20L/0410,

58442/1LL/0410



Product Name: Campbell Magnate 750WG Fungicide Applicant Name: Colin Campbell (Chemicals) Pty Ltd Applicant ACN: 000 045 590 Summary of Variation: To add an additional pack size and extend the use to the control of a range of fungal

diseases in Rockmelons. Date of Variation: 2 June 2010 Label Approval No: 52223/1kg/0110, 52223/1M/0110, 52223/25kg/0110

6. RESTRICTED PRODUCT VARIATION

No entries.



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.

7. RESTRICTED PRODUCT

No entries.

8. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS

No entries.

9. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: Morabec Allworming Horse Paste Active Constituent/s: Each gram of paste contains 4mg abamectin, 167mg morantel tartrate Applicant Name: Arkolette Pty Ltd T/A Riverside Veterinary Products Applicant ACN: 059 860 589 Summary of Use: For the treatment and control of roundworms (including arterial larval stages of Strongylus

vulgaris and benzimidazole resistant small strongyles), lungworms, tapeworms, bots and skin lesions caused by larvae of Habronema spp. And Draschia spp (summer sores) and the microfilaria of Onchocera spp

Date of Registration: 10 May 2010 Label Approval No: 60383/32.5/0310

Product Name: Ilium Medetomidine Injection Active Constituent/s: 1mg/mL medetomidine hydrochloride Applicant Name: Troy Laboratories Pty Ltd Applicant ACN: 000 283 769 Summary of Use: An injectable sedative and analgesic for use in cats and dogs. Date of Registration: 20 May 2010 Label Approval No: 64251/10ML/0410, 64251/0410

Product Name: Stockrite Ivermectin Pour-On For Beef And Dairy Cattle Active Constituent/s: 5g/L ivermectin Applicant Name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of Use: For the control of ivermectin-sensitive internal and external parasites of cattle. Date of Registration: 31 May 2010 Label Approval No: 64771/500/0110, 64771/1/0110, 64771/2/0110, 64771/2.25/0110, 64771/5/0110,

64771/6/0110, 64771/10/0110, 64771/12/0110¸64771/15/0110, 64771/17/0110, 64771/20/0110, 64771/25/0110



Product Name: Pharmachem Meloxivet Active Constituent/s: 1.5mg/mL meloxicam Applicant Name: Bocko Pty Ltd & Flexsky Pty Ltd (In Partnership) T/A Pharmachem Applicant ACN: 078 722 371 Summary of Use: For the alleviation of inflammation and pain in both acute and chronic musculoskeletal

disorders in dogs. Date of Registration: 31 May 2010 Label Approval No: 64854/10mL/0310, 64854/30mL/0310, 64854/100mL/0310, 64854/0310

10. LISTED REGISTRATIONS

No entries.

11. VARIATIONS

Product Name: Cartrophen Vet Injection Of Pentosan Polysulfate Applicant Name: Biopharm Australia Pty Ltd Applicant ACN: 003 425 803 Summary of Variation: Extend use to include aid in treatment of non-infectious anti-inflammatory joint disease in

horses. Date of Variation: 25 May 2010 Label Approval No: 36037/1/0310, 36037/12/0310, 36037/0310

12. RESTRICTED PRODUCT VARIATION

No entries.



NOTICE – NEW VETERINARY CHEMICAL PRODUCTS

Monepantel in the product Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Novartis Animal Health Australasia Pty Ltd, for registration of a new product containing monepantel. The product is ZOLVIX MONEPANTEL BROAD SPECTRUM ORAL ANTHELMINTIC FOR SHEEP. The product is for use in sheep for the treatment and control of amino-acetonitrile derivative (AAD) sensitive strains of gastro-intestinal roundworms (nematodes), including macrocyclic lactone, benzimidazole, levamisole and morantel-resistant strains.

PARTICULARS OF THE ACTIVE CONSTITUENT

Common Name: Monepantel (INN)

Chemical Name: N-[(1S)-1-Cyano-2-(5-cyano-2-fluoromethylphenoxy)-1-methylethyl]-4-trifluoromethylsulfanylbenzamide

CAS Registry Number: 887148-69-8

Molecular Formula: C20H13F6N3O2S

Molecular Weight: 473.39

Structure:

Chemical Family: Amino-Acetonitrile Derivatives (AAD)

O

HN

O

SCF3

NC

CN

CF3

SUMMARY OF THE APVMA’S EVALUATION OF MONEPANTEL ACTIVE CONSTITUENT

Monepantel is a new active constituent and there is no compendial specification available.

The Pharmaceutical Chemistry Section of the APVMA has evaluated the chemistry and manufacturing aspects of monepantel and is satisfied that all the data requirements (including the physico-chemical properties, spectral identification, manufacturing and quality control aspects, impurity formation, active constituent specification, stability, batch analysis data, analytical methods and packaging information) necessary for the approval of this new active constituent have been met.

Notice – New Veterinary Chemical Products - Monepantel in the product Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep


PARTICULARS OF THE APPLICATION

Proposed Product Name(s): ZOLVIX MONEPANTEL BROAD SPECTRUM ORAL ANTHELMINTIC FOR SHEEP

Applicant Company: Novartis Animal Health Australasia Pty Ltd

Name of Active Constituent: Monepantel

Signal Heading: Schedule 5

Summary of Proposed Use: Treatment and control of AAD-sensitive strains of gastro-intestinal roundworms (nematodes), including macrocyclic lactone, benzimidazole, levamisole and morantel-resistant strains in sheep.

Pack Sizes: 0.25L, 0.5L, 1L, 2.5L, 5L, 10L

Table 1

MM 0822 Sheep muscle 0.7 mg/kg

MF 0822 Sheep fat 7 mg/kg

MO 1288 Sheep kidney 2 mg/kg

Maximum Residue Limits:

MO 1289 Sheep liver 5 mg/kg

Residue Definition: Table 3

Monepantel sulphone

Withholding Period: Withholding Periods:

MEAT: DO NOT USE less than 14 days before slaughter for human consumption.

MILK: DO NOT USE in female sheep which are producing or may in the future produce milk or milk products for human consumption.

Retreatment interval:

DO NOT re-treat less than 21 days after the last treatment. After three consecutive treatments, 115 days must elapse before treating again with Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep.

Trade Advice:

EXPORT SLAUGHTER INTERVAL (ESI): DO NOT slaughter for export less than 115 days after treatment.



SUMMARY OF THE APVMA’S EVALUATION OF ZOLVIX 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 ZOLVIX MONEPANTEL BROAD SPECTRUM ORAL ANTHELMINTIC FOR SHEEP would not be an undue hazard to the safety of people exposed to it during its handling and use.

The Office of Chemical Safety and Environmental Health (OCSEH) in the Department of Health and Ageing has conducted a risk assessment on the product and concluded that it can be used safely.

The active constituent, monepantel, has low acute oral and dermal toxicity. It is not a skin irritant or skin sensitiser but it is a slight eye irritant. No information is available on its acute inhalational toxicity. Studies showed that monepantel is not carcinogenic, mutagenic, genotoxic or a developmental toxicant.

The product, Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep, has low acute oral and dermal toxicity. It is a slight skin and eye irritant and a skin sensitiser. No information is available on its acute inhalational toxicity.

First aid instructions and safety directions are required and are included on the label.

The APVMA has considered the findings and recommendations of the OCSEH evaluation and accepts these findings and recommendations.

(ii) The APVMA is satisfied that the proposed use of ZOLVIX MONEPANTEL BROAD SPECTRUM ORAL ANTHELMINTIC FOR SHEEP will not be an undue hazard to the safety of people using anything containing its residues.

The APVMA has assessed the residues data and Maximum Residue Limits (MRLs) are recommended for Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep. Withholding periods and re-treatment intervals have been established. The product is not for use in female sheep which are producing or may in the future produce milk or milk products for human consumption. The APVMA has conducted a dietary risk assessment and has found that the chronic dietary exposures to monepantel residues are acceptable. An estimate of the acute dietary exposure to monepantel has not been performed.

(iii) The APVMA is satisfied that the proposed use of ZOLVIX MONEPANTEL BROAD SPECTRUM ORAL ANTHELMINTIC FOR SHEEP containing the active constituent, monepantel, is not likely to be harmful to human beings if used according to the product label directions.

The APVMA has evaluated and proposes to approve the active constituent, monepantel, and finds that the chemistry and manufacturing details of the product, Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep, are acceptable. The National Drugs and Poisons Scheduling Committee has assessed monepantel and has included it in Schedule 5 of the Standard for the Uniform Scheduling of Drugs and Poisons. The signal heading that corresponds to Schedule 5 and the first aid instructions and safety directions recommended by OCSEH appear on the product label.



Monepantel is not classified as a hazardous substance but Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep is determined to be a hazardous substance.

The APVMA has considered the findings of its advisors on this criterion and accepts their recommendations.

(iv) The APVMA is satisfied that the proposed use of ZOLVIX MONEPANTEL BROAD SPECTRUM ORAL ANTHELMINTIC FOR SHEEP containing the active constituent, monepantel, is not likely to have an unintended effect that is harmful to animals, plants or the environment if used according to the product label instructions.

The APVMA is satisfied that the proposed use of the new product, Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep, containing the new active constituent, monepantel, would not be likely to have an unintended effect that is harmful to animals, plants or things, or to the environment.

Monepantel is slightly to fairly degraded in aerobic soils and is not persistent. It is considered to be immobile in soils. Based on the determined log Kow of 4.2-4.7, it has the potential for bioaccumulation in aquatic organisms but metabolism is high and aquatic exposure is low.

Monepantel is considered to be non-toxic to fish, aquatic invertebrates and algae up to its limit of water solubility. Risk assessment of the proposed use indicates acceptable risk to the aquatic compartment. Given its low toxicity to terrestrial organisms and low concentration in soils, there is unlikely to be an unacceptable risk to the terrestrial compartment.

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

The APVMA has considered the findings of DEWHA and accepts its recommendations on this criterion.

(v) The APVMA is considering whether the proposed use of ZOLVIX MONEPANTEL BROAD SPECTRUM ORAL ANTHELMINTIC FOR SHEEP would not adversely affect trade between Australia and places outside Australia.

Codex has not considered monepantel. The EU has established MRLs/tolerances for monepantel and these are the same as the proposed Australian MRLs. However, other countries considered by the APVMA when determining ESIs have not established MRLs/tolerances for monepantel in sheep commodities, therefore these countries are considered to be the most sensitive export markets for Australian sheep commodities containing monepantel. In the absence of importing standards in China, CIS, Japan, Saudi Arabia, UAE, USA and Codex for monepantel residues in edible tissues, the APVMA has concluded that the appropriate ‘endpoint’ for determination of the Export Slaughter Interval (ESI) for Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep is the Limit of Quantitation (LOQ) of the validated analytical method (0.01 mg/kg). The APVMA has assessed the residues data and has determined that an export slaughter interval of 115 days would be required for monepantel residues to decline to below the LOQ.

The APVMA has concluded that the risk to Australia’s export trade in sheep commodities is considered to be low when the recommended ESI of 115 days is observed for Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Sheep.

(vi) In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials supporting the efficacy of the product adequately demonstrate that if used according to the product label directions, the product is effective for its proposed uses.



FUTHER INFORMATION

A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Consultation’ section, www.apvma.gov.au or by contacting the evaluator listed below.

MAKING A SUBMISSION

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 of ZOLVIX MONEPANTEL BROAD SPECTRUM ORAL ANTHELMINTIC FOR SHEEP should be granted. Submissions should relate only to matters that the APVMA is required by legislation to take into account in deciding whether to grant the application. These grounds include occupational health and safety, chemistry and manufacture, residues, safety and first aid, environmental fate and toxicity, trade and efficacy. Submissions should state the grounds on which they are based. Comments received outside these grounds cannot be considered by the APVMA.

Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and in determining appropriate conditions of registration and product labelling.

When making a submission please include:

• Contact name • Company or Group name (if relevant) • Postal Address • Email Address (if available) • The date you made the submission.

All personal and confidential commercial information (CCI)1 material contained in submissions will be treated confidentially.

Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for registration should be addressed in writing to:

Zuzanna Rajczyk Veterinary Medicines Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4733 Fax: (02) 6210 4741 Email: [email protected]

1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.



http://www.comlaw.gov.au/ComLaw/Legislation/ActCompilation1.nsf/current/bytitle/A06DDA96E680781ECA2573120082EBE6?OpenDocument&mostrecent=1


* 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 Other Notices - Licensing of Veterinary Chemical Manufacturers

OTHER NOTICES

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 website, www.apvma.gov.au.

1. NEW LICENCES

JALCO PHARMACEUTICALS PTY LIMITED

LICENCE NO: 2209

Product Types:* • Category 2: Tablets, creams/lotions, ointments, pastes, powders, liquids,

suspensions and gels.

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, dry milling, wet milling, granulation, filling, packaging, labelling, strip, blister or sachet packaging, tableting, tablet coating, analysis and testing (physical and chemical), storage and release for supply.

ACN: 136 806 936

19A Garema Circuit

KINGSGROVE NSW 2208

Licence Issued: 30/04/2010

RAPIDVITE INDUSTRIES AUSTRALASIA PTY. LTD.

LICENCE NO: 2208

Product Types:* • Category 2: Pastes, powders and liquids • Category 4: Premixes and supplements

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, dry milling, filling, packaging, labelling, analysis and testing (physical), storage and release for supply.

ACN: 006 269 683

Factory 2, 49 Power Road

BAYSWATER VIC 3153





ZAMIRA LIFE SCIENCES PTY LTD

LICENCE NO: 6156

Product Types:* • Category 6: Single Step

Step(s) of Manufacture: Quality assurance (QA) of raw materials, secondary packaging, labelling, analysis and testing (physical), storage and release for supply.

ACN: 130 641 502

24 Parkhurst Drive

KNOXFIELD VIC 3180


2. CHANGES TO EXISTING LICENCES

CLYDE CONTRACT FILLERS PTY LTD

LICENCE NO: 6131

Product Types: * • Category 6: Single step manufacture

Step(s) of Manufacture: Filling, packaging, labelling, analysis and testing (physical) and storage.

ACN: 000 533 684

5 Kelray Place

ASQUITH NSW 2077

Amended Licence Issued: 21/04/2010

Change of key personnel and variation of licence conditions

RUAKURA PTY LIMITED LICENCE NO: 2022

Product Types: * • Category 2: Liquids

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, analysis and testing (physical and chemical), storage and release for supply.

ACN: 003 632 120

Unit 2, 12 Blackmore Road NARELLAN NSW 2567

Amended Licence Issued: 26/03/2010, change to key personnel



ORION LABORATORIES PTY. LTD.

LICENCE NO: 2177

Product Types: * • Category 2: Creams/lotions, ointments, pastes, powders, liquids • Category 4: Premixes and supplements

Step(s) of Manufacture: Formulation including blending, filling, packaging, labelling, analysis and testing (physical, chemical), storage and release for supply.

ACN: 009 293 136

25-29 Delawney Street

BALCATTA WA 6021

Amended Licence Issued: 30/04/2010

Removal of licence condition

3. LICENCE CANCELLATIONS

The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’].

Nil

4. LICENCE SUSPENSIONS

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

Nil

5. REVOCATION OF LICENCE CANCELLATION

The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’].

Nil

6. REVOCATION OF LICENCE SUSPENSION

The APVMA has revoked the suspension of the following licences under subsection 127(7) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’].

Nil



APVMA CONTACT

Dounia Houzaife GMP Officer, GMP Section Veterinary Medicines Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4808 Fax: (02) 6210 4741 Email: [email protected]


Amendments to the MRL Standard

AMENDMENT NO. 12M

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 website, www.apvma.gov.au

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)

Boscalid

DELETE:

FP 0226 Apple 2

ADD:

FP 0009 Pome fruits 2

Other Notices - Amendments to the MRL Standard




Etoxazole

ADD:

FI 0327 Banana T0.05

Fenvalerate

DELETE:

FB 0269 Grapes *0.05

ADD:

DF 0269 Dried grapes (= currants, Raisins and Sultanas) 0.5

FB 0269 Grapes 0.1

Fludioxonil

ADD:

FS 0240 Apricot 10

FC 0001 Citrus fruits 10

FI 0341 Kiwifruit 15

FS 0247 Peach 10


FS 0012 Stone fruits [except apricots and peaches] 5

Iodosulfuron methyl

ADD:

GC 0640 Barley *0.01

ADD:

Ipconazole

GC 0080 Cereal grains *0.01

MO 0105 Edible offal (Mammalian) *0.01

PE 0112 Eggs *0.01

MM 0095 Meat [mammalian] *0.01




ML 0106 Milks *0.01

PO 0111 Poultry, Edible offal of *0.01

PM 0110 Poultry meat *0.01

Oxyfluorfen

ADD:

FT 0305 Olives 0.05

Pyraclostrobin

DELETE:

FP 0226 Apple 1

MO 0105 Edible offal (Mammalian) *0.05

ADD:

MO 0105 Edible offal (Mammalian) 0.1

VO 0050 Fruiting vegetables, other than Cucurbits 0.3

FI 0345 Mango 0.1


SO 0698 Poppy seed *0.05

TABLE 3: RESIDUE DEFINITION

Where MRL(s) are recommended, the following residue definitions are applicable.

COMPOUND RESIDUE

ADD:

Ipconazole Ipconazole

DELETE:

Mefenpyr-diethyl Mefenpyr-diethyl



COMPOUND RESIDUE

ADD:

Mefenpyr-diethyl Commodities of plant origin: Sum of mefenpyr-diethyl and metabolites hydrolysed to 1-(2,4-dichlorophenyl)-5-methyl-2-pyrazoline-3,5-dicarboxylic acid, and 1-(2,4-dichlorophenyl)-5-methyl-pyrazole-3-carboxylic acid, expressed as mefenpyr-diethyl.

Commodities of animal origin: Sum of mefenpyr-diethyl and 1-(2,4-dichlorophenyl)-5-ethoxycarbonyl-5-methyl-2-pyrazoline-3-carboxylic acid, expressed as mefenpyr-diethyl.

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)

Boscalid

DELETE:

AB 0226 Apple pomace, dry 20

ADD:


Fenvalerate

DELETE:

AL 1020 Alfalfa fodder 2

AL 1021 Alfalfa forage (green) 2

ADD:

AL 1020 Alfalfa fodder 5

AL 1021 Alfalfa forage (green) 5

AB 0269 Grape pomace, dry 0.5

Fludioxonil

ADD:


AB 0001 Citrus pulp, dry 30



COMPOUND ANIMAL FEED COMMODITY MRL (mg/kg)

Iodosulfuron methyl

DELETE:

Wheat forage (fresh weight) *0.05

AS 0654 Wheat, straw and fodder, dry *0.05

ADD:

AF 0081 Forage of cereal grains 0.5

AS 0081 Straw and fodder (dry) of cereal grains *0.05

ADD:

Ipconazole

AF 0081 Forage of cereal grains *0.01


Mefenpyr-diethyl

DELETE:

Cereal forage (fresh weight) *0.1


ADD:

AF 0081 Forage of cereal grains 3

AS 0081 Straw and fodder (dry) of cereal grains 1

Propiconazole

DELETE:

SO 0702 Sunflower seed T7

Pyraclostrobin

ADD:

Tomato pomace (dry) 5



TABLE 5: USES OF SUBSTANCES WHERE MAXIMUM RESIDUE LIMITS ARE NOT NECESSARY

SUBSTANCE USE

ADD:

Endothal For use in irrigation channels for the control of various aquatic weeds

Gonadotrophin Releasing Factor (GnRF)-protein conjugate

ADD: Vaccine for the suppression of progesterone production in female cattle

APVMA CONTACT

For further information please contact:

Michelle Hemming 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]



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. 10, 25 MAY 2010.

Application No. Name

48054 NOT AVAILABLE

49057 MACPHERSONS HYMAX AQUATIC HERBICIDE

49196 4FARMERS PROPYZAMIDE 500SC HERBICIDE

49323 DIFENOCONAZOLE

49597 CLIK SPRAY-ON SHEEP BLOWFLY TREATMENT

49645 IMAX CD POUR-ON FOR CATTLE

49801 NOT AVAILABLE

49824 GENFARM DIFLU- MCPA SELECTIVE HERBICIDE

49918 NOT AVAILABLE

49922 IMTRADE LIONEX SELECTIVE HERBICIDE

49959 BIOCLEAR PARAFFINIC OIL

49972 TERMGUARD MAXXTHOR 100 WATER-BASED TERMITICIDE AND INSECTICIDE

49982 BLUE STAR GLYPHOSATE 450 HERBICIDE

49985 SURFS UP 700 SURFACTANT

49990 SMART METSULFRON 600 WG HERBICIDE

50001 NOT AVAILABLE

50002 NOT AVAILABLE

50027 CONQUEST EXPLODE 250 HERBICIDE

50040 TILT 250 EC FUNGICIDE

50050 IMTRADE CYPERSHIELD 200 INSECTICIDE

47988 CHEMFORCE METSULFURON 600WG HERBICIDE

Other Notices - Application Summaries



Application No. Name

48624 PHYTOCLEAN SANITISER

48779 COLES CRAWLING INSECT KILLER HIGH PERFORMANCE

48780 COLES CRAWLING INSECT KILLER ODOURLESS

49135 AQUA-HEALTH CHLORINE CONCENTRATE

49496 COOPERS IMIZOL

49565 POOL MAGIC TRICHLOR STICKS STABILISED CHLORINE STICKS

49594 TORPEDO HERBICIDE

49610 NOT AVAILABLE

49638 YATES TOMATO DUST

49742 CHEMFORCE PROPYZAMIDE 500 SELECTIVE HERBICIDE

49797 MORTEIN ODOURLESS MOZZIE AND FLY ZAPPER

49800 RYGEL HALOXYFOP 520 HERBICIDE

49813 YATES KILLS WEEDS LUSH BINDII & BROADLEAF WEEDER

49847 BOMECTIN F BROAD-SPECTRUM ANTIPARASITIC INJECTION FOR CATTLE

49856 BIOTIS CLETHODIM 240EC SELECTIVE HERBICIDE

49873 POOL MAGIC MINI TABLETS STABALISED POOL TABLETS

49876 SEQUENCE HERBICIDE

49991 FARMALINX SNAIL TRAIL SNAIL AND SLUG PELLETS

50011 TIMTECH BLOCKADE ""TRUE BLUE"" TERMITICIDE & INSECTICIDE

50014 SQUARE DOWN 450 HERBICIDE

50016 SQUARE DOWN 480 SELECTIVE HERBICIDE

50018 TITAN QUIZALOFOP-P-ETHYL 99.5 HERBICIDE

50022 NOT AVAILABLE

50025 NOT AVAILABLE

50033 NOT AVAILABLE

50054 GUARDEX POOL SANITISER ADVANTAGE CHLOR

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



Application No. Product/Active Constituent Name

46508 CARTROPHEN VET INJECTION OF PENTOSAN POLYSULFATE

45789 VIVANDO FUNGICIDE

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 4700 Fax: (02) 6210 4721


apvma gazette no. 11, 8 june 2010 · 2014-09-25 · applicant acn: 130 864 603 summary of use: for...

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