No. APVMA 7, Tuesday, 10 April 2012 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. ISSN 1837 - 7629
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APVMA Gazette no. 7, 10 April 2012 · No. APVMA 7, Tuesday, 10 April 2012 AGRICULTURAL AND Published by The Australian Pesticides & Veterinary Medicines Authority VETERINARY CHEMICALS
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No. APVMA 7, Tuesday, 10 April 2012
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.
ISSN 1837 - 7629
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 2
Commonwealth of Australia 2012
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:
The Manager, Public Affairs
The Australian Pesticides and Veterinary Medicines Authority
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Notice of Registrations 4 Agricultural Chemical Products .............................................................................................................................................. 4 Veterinary Chemical Products .............................................................................................................................................. 13
Notice – New Agricultural Chemical Products 15 Prosulfuron in the product Casper Turf Herbicide ................................................................................................................ 15 Particulars of The Application ............................................................................................................................................... 15
Other Notices 19 Licensing of Veterinary Chemical Manufacturers ................................................................................................................. 19 Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene ........................................................................................................................................ 22 Cancellation of Label Approvals of Products Containing Virginiamycin................................................................................ 25 Voluntary Cancellation of Label Approvals at the Request of the Registrants...................................................................... 27 Amendments to the APVMA MRL Standard ......................................................................................................................... 29 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code................................................... 34 Addendum to the Record of Approved Active Constituents .................................................................................................. 37 Application Summaries ......................................................................................................................................................... 39
Erratum Notice
The Australian Pesticides and Veterinary Medicines Authority advises that an error was published in the
Commonwealth of Australia Gazette for Agricultural and Veterinary Chemicals, No. APVMA 5, Tuesday 13 March 2012.
In the Notice for Excede Sterile Suspension, the active constituent was misspelled.
The correct entry for the Notice of Registration for Excede Sterile Suspension appears on page 13 of this Gazette.
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 4
Notice of Registrations
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
Summary of Use: For the reduction of vegetative growth in mango, stonefruit and apple trees
Date of Registration: 23 March 2012
Label Approval No: 66861/54546
Product Name: Agspray 2,4-D IPA 300 Herbicide
Active Constituent/s: 300g/L 2,4-D present as the isopropylamine salt
Applicant Name: Agspray Chemical Co. Pty. Ltd.
Applicant ACN: 005 329 573
Summary of Use: For the control of emerged broadleaf weeds prior to sowing crops and pastures in conservation tillage situations and for selective weed control in crops
Date of Registration: 23 March 2012
Label Approval No: 67141/55302
Product Name: Value Fluroxypyr 200 Herbicide
Active Constituent/s: 200g/L fluroxypyr present as the methyl heptyl ester
Applicant Name: Value Chem Pty Ltd
Applicant ACN: 151 004 223
Summary of Use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, pastures, sorghum, sugar cane, sweet corn, winter cereals
Date of Registration: 23 March 2012
Label Approval No: 66991/54883
Product Name: Nova Agro Chlorsulfuron 750 WG Herbicide
Active Constituent/s: 750g/kg chlorsulfuron
Applicant Name: Nova Agro Pty Ltd
Applicant ACN: 153 121 156
Summary of Use: For the control of annual (Wimmera) ryegrass and certain broadleaved weeds in wheat, barley, oats, cereal rye and triticale
Date of Registration: 23 March 2012
Label Approval No: 67097/55197
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 6
Active Constituent/s: 330g/kg phosphine (PHз) present as aluminium phosphide
Applicant Name: Apparent Pty. Ltd.
Applicant ACN: 143 724 136
Summary of Use: For the control of insect pests in certain situations and control of rabbits in burrows
Date of Registration: 23 March 2012
Label Approval No: 67374/55902
Product Name: Kenso Agcare Captan 800 WG Fungicide
Active Constituent/s: 800g/kg captan
Applicant Name: Kenso Corporation (M) Sdn. Bhd.
Applicant ACN: N/A
Summary of Use: For the control of certain diseases in a range of fruit crops, turf and ornamentals
Date of Registration: 26 March 2012
Label Approval No: 66892/54638
Product Name: Value Glyphosate 450 SL Herbicide
Active Constituent/s: 450g/L glyphosate present as the isopropylamine salt
Applicant Name: Value Chem Pty Ltd
Applicant ACN: 151 004 223
Summary of Use: For the non-selective herbicide control of most emerged weeds and plants in situations as indicated in the directions for use table
Date of Registration: 26 March 2012
Label Approval No: 66992/54884
Product Name: Nova Agro Paraquat 250 SL Herbicide
Active Constituent/s: 250g/L paraquat present as paraquat dichloride
Applicant Name: Nova Agro Pty Ltd
Applicant ACN: 153 121 156
Summary of Use: For the control of a wide range of grasses and broadleaf weeds
Date of Registration: 26 March 2012
Label Approval No: 67163/55370
Product Name: Freezone Fenitrothion Insecticide
Active Constituent/s: 1000g/L fenitrothion
Applicant Name: Freezone Public Health Pty Ltd
Applicant ACN: 132 080 098
Summary of Use: For the control of locust and grasshopper pests of broad acre and horticultural crops, for the protection of cereal grain against stored product insect pests and for the control of various pests of pasture
Date of Registration: 26 March 2012
Label Approval No: 67186/55411
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 7
Notice of Registrations
Product Name: Value MCPA 500 Selective Herbicide
Active Constituent/s: 500g/L MCPA present as the dimethylamine salt
Applicant Name: Value Chem Pty Ltd
Applicant ACN: 151 004 223
Summary of Use: For selective control of broadleaf weeds in cereals, field peas, linseed, pastures, sugar cane and turf
Date of Registration: 26 March 2012
Label Approval No: 66993/54885
Product Name: Protect-Us Crawling Insect Spray
Active Constituent/s: 0.7g/kg imiprothrin, 2g/kg cypermethrin
Applicant Name: Ensystex Australasia Pty Ltd
Applicant ACN: 102 221 965
Summary of Use: For use in domestic and commercial situations for control of f lying and crawling insect pests
Date of Registration: 27 March 2012
Label Approval No: 67040/55010
Product Name: Protect-Us Fast Knockdown Aerosol Insecticide
Active Constituent/s: 3.82g/kg tetramethrin, 1.19g/kg bioallethrin, 0.75g/kg bioresmethrin
Applicant Name: Ensystex Australasia Pty Ltd
Applicant ACN: 102 221 965
Summary of Use: For control of flying and crawling insect pests
Date of Registration: 27 March 2012
Label Approval No: 67041/55012
Product Name: Country Triclopyr 600 Herbicide
Active Constituent/s: 600g/L triclopyr present as butoxyethyl ester
Applicant Name: Accensi Pty Ltd
Applicant ACN: 079 875 184
Summary of Use: For the control of a range of woody weeds and melons
Date of Registration: 28 March 2012
Label Approval No: 67235/55541
Product Name: Zelam Brushweed Herbicide
Active Constituent/s: 75g/L triclopyr present as the butoxyethyl ester, 28g/L metsulfuron-methyl
Applicant Name: Zelam Pty Ltd
Applicant ACN: 082 428 028
Summary of Use: For the control of certain brush species in native pasture, rights of way and commercial and industrial areas
Date of Registration: 28 March 2012
Label Approval No: 67234/55539
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 8
Notice of Registrations
Product Name: Fabulous Fly And Insect Spray Regular
Summary of Use: For protection against flying and crawling insects
Date of Registration: 28 March 2012
Label Approval No: 67133/55292
Product Name: Coles Smart Buy Surface Spray Low Irritant
Active Constituent/s: 2.79g/kg permethrin 25:75, 1.38g/kg tetramethrin 20:80
Applicant Name: Coles Supermarkets Australia Pty Ltd
Applicant ACN: 004 189 708
Summary of Use: For control of cockroaches, silverfish, ants, carpet beetles, fleas, spiders, bedbugs and clothes moths in household situations
Date of Registration: 28 March 2012
Label Approval No: 67106/55221
Product Name: Triasulflex 750 WG Herbicide
Active Constituent/s: 750g/kg triasulfuron
Applicant Name: Hextar Chemicals Pty Ltd
Applicant ACN: 114 525 709
Summary of Use: For pre-plant control of annual ryegrass, Paradoxa grass and certain broadleaf weeds in wheat and for post-emergent control of wild radish in wheat, oats and barley
Date of Registration: 29 March 2012
Label Approval No: 66902/54658
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 9
Notice of Registrations
Product Name: Agrocelhone C Soil Fumigant
Active Constituent/s: 985g/kg chloropicrin
Applicant Name: Agroquimicos De Levante, S.A.
Applicant ACN: N/A
Summary of Use: For the control of certain soil-borne pests
Date of Registration: 2 April 2012
Label Approval No: 67260/55639
Product Name: Rainbow Imazethapyr 700 WG Herbicide
Active Constituent/s: 700g/kg imazethapyr
Applicant Name: Shandong Rainbow International Co., Ltd.
Applicant ACN: N/A
Summary of Use: For the pre-or post-emergence control of certain weeds in centrosema (cavalcade), chickpeas, faba beans, field peas, lucerne, mung beans, peanuts, serradella, soybeans and subterranean clover
Date of Registration: 3 April 2012
Label Approval No: 67297/55709
Product Name: Searles Trifend Garden Spray
Active Constituent/s: 9.6g/L tau-fluvalinate, 4.4g/L myclobutanil
Applicant Name: J C & A T Searle Pty Ltd
Applicant ACN: 002 898 893
Summary of Use: For use as an insecticide to kill aphids, thrips, whitefly, budworm and earworm caterpillars; as fungicide for the systemic control of blackspot, rust and powdery mildew; and as a miticide to control two-spotted mite in the home garden
Date of Registration: 3 April 2012
Label Approval No: 67250/55595
Product Name: AC Orca 700 Surfactant
Active Constituent/s: 350g/L soyal phospholipids, 353g/L propionic acid
Applicant Name: Axichem Pty Ltd
Applicant ACN: 131 628 594
Summary of Use: For the use as an acidifying and penetrating surfactant
Date of Registration: 3 April 2012
Label Approval No: 67023/55432
Product Name: Protect-Us Ensystex Professional Gel Cockroach Bait
Active Constituent/s: 0.5g/kg fipronil
Applicant Name: Ensystex Australasia Pty Ltd
Applicant ACN: 102 221 965
Summary of Use: For the control of cockroaches in domestic and commercial premises.
Date of Registration: 3 April 2012
Label Approval No: 67049/55079
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 10
Summary of Variation: To change the product name from ‘CHEMAG CARBENDAZIM 500 SC FUNGICIDE’ to ‘IMTRADE CARBENDAZIM 500 SC FUNGICIDE’, and to remove the use patterns for apples, pears, citrus, grapes, mango, stone fruit, cucurbits and turf
Summary of Variation: To vary the product name from ‘UNITED FARMERS T-OIL SPRAY TANK ADJUVANT’ to ‘RAVENSDOWN T-OIL SPRAY TANK ADJUVANT’
Date of Variation: 27 March 2012
Label Approval No: 60715/53699
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 11
Notice of Registrations
Product Name: Yates Tree And Blackberry Killer
Applicant Name: Duluxgroup (Australia) Pty Ltd
Applicant ACN: 000 049 427
Summary of Variation: To add additional uses for a range of weeds in the home and garden and change the product name from ‘YATES NON SELECTIVE ZERO WOODY WEEDER’ to ‘YATES TREE AND BLACKBERRY KILLER’
Date of Variation: 28 March 2012
Label Approval No: 58023/55097
Product Name: Cropro Pounce Insecticide
Applicant Name: PCT Holdings Pty Ltd
Applicant ACN: 099 023 962
Summary of Variation: To copy uses from a closely similar reference product and to add additional pack sizes
Date of Variation: 28 March 2012
Label Approval No: 51760/55136
Product Name: Elantra Xtreme Herbicide
Applicant Name: Sipcam Pacific Australia Pty Ltd
Applicant ACN: 073 176 888
Summary of Variation: To change the compatibilities to allow tank mixing with oil-based adjuvants
Date of Variation: 28 March 2012
Label Approval No: 65044/51880
Product Name: Milbeknock Miticide
Applicant Name: Sipcam Pacific Australia Pty Ltd
Applicant ACN: 073 176 888
Summary of Variation: To extend the label claims to include control of two-spotted mite in capsicums
Date of Variation: 29 March 2012
Label Approval No: 61269/54102
Product Name: Ecopar Herbicide
Applicant Name: Sipcam Pacific Australia Pty Ltd
Applicant ACN: 073 176 888
Summary of Variation: To include control of various broadleaf weeds in pastures and include use as tank m ix with glyphosate formulations
Date of Variation: 29 March 2012
Label Approval No: 60493/55023
Product Name: Blue Planet Algae Cure
Applicant Name: Beaphar Australia Pty Ltd
Applicant ACN: 145 418 882
Summary of Variation: To change product name from ‘ARISTOPET AQUA MASTER ALGAE CURE’ to ‘BLUE PLANET ALGAE CURE’
Date of Variation: 2 April 2012
Label Approval No: 46813/54744
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 12
Notice of Registrations
Product Name: Zolo 430 SC Fungicide
Applicant Name: United Phosphorus Ltd.
Applicant ACN: 066 391 384
Summary of Variation: To approve an extension of use on grapes, lettuce and sugarcane
Summary of Variation: To change product name from ‘MORTEIN LOW ALLERGENIC FLY & MOSQUITO KILLER’ to ‘MORTEIN FAST KNOCKDOWN FLY & MOSQUITO KILLER LOW ALLERGENIC’
Date of Variation: 3 April 2012
Label Approval No: 54137/55708
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 13
Notice of Registrations
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: Excede Sterile Suspension
Active Constituent/s: 200mg/mL ceftiofur as ceftiofur crystalline free acid
Applicant Name: Pfizer Animal Health A Div Of Pfizer Australia Pty Ltd
Applicant ACN: 008 422 348
Summary of Use: For the treatment of bovine respiratory diseases caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 22
Other Notices - Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene
Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene
The APVMA has decided to continue the suspension of the active constituent approvals for quintozene listed in Table 1
and the product registrations and label approvals of products containing quintozene listed in Table 2.
Table 1: Active constituent approvals for quintozene
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 23
Other Notices - Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene
The active constituent approval suspensions are in effect from 14 April 2012 until 14 April 2013.
The product and label suspensions apply as a consequence of the decision to continue the suspension of quintozene
active constituent approvals and are in effect from 14 April 2012 until 14 April 2013.
BASIS FOR CONTINUED SUSPENSION
The APVMA became aware of information in 2010 indicating the presence of undeclared dioxins as impurities in
products that contain quintozene as the active constituent. On this basis, the APVMA suspended quintozene active
approvals, effective 9 April 2010 until 12 April 2011. In April 2011, the APVMA acted again to continue the suspension of
all approvals of the active constituent quintozene for a further 12 months, to allow the manufacturer additional time to
generate the necessary data. The manufacturer has recently provided the APVMA with additional data and to allow
sufficient time to consider this application, the APVMA has continued the suspension of all approvals of the active
constituent quintozene for a further 12 months until 14 April 2013. Dioxins are listed as toxicologically significant
impurities in the Definition of Standards for Active Constituents (see
http://www.apvma.gov.au/products/constituents/standards/actives_definition.php). The presence of any impurity that is
listed as toxicologically significant is a matter that the APVMA considers to be a relevant particular to the approval of an
active constituent.
As stated in the Agricultural Manual of Requirements and Guidelines (AgMORAG)
(http://www.apvma.gov.au/products/constituents/standards/actives_definition.php), an active constituent approval is not
supportable unless any known impurities of toxicological significance have been adequately evaluated. AgMORAG
specifies that an impurity that is present at levels above 0.1 mg/kg should be declared and evaluated, and also
emphasises that toxicologically significant impurities in the active constituent should be declared when present,
regardless of the level present.
The APVMA considers that the active constituent quintozene may be an undue hazard to the safety of people exposed to
it during its handling and may have an effect that is harmful to human beings. A full assessment of the dioxin impurities
has not been conducted in accordance with section 14 of the Agvet Code Act. On this basis the APVMA has concluded
that it cannot allow the active constituent to be supplied and used in chemical products when it contains undeclared
dioxins. Consequently, the APVMA has suspended the approvals of quintozene active constituents.
The Agvet Code provides that if the APVMA suspends the only approval, or all the approvals, of an active constituent for
an existing chemical product, it must also suspend any registration of that product. In addition, if the APVMA suspends
the registration of a chemical product, it may also suspend any approval relating to a label for containers for the product.
IMPACT ON PRODUCT REGISTRANTS
Suspension action is based on the concern that undeclared dioxins may be present in quintozene active constituents and
formulated products. The APVMA considers that it may be possible to allow some use of existing stocks of quintozene
products during the period of suspension. Continued uses will only be permitted on the basis of test results for total
dioxins in each batch of product proposed for use, and following evaluation by the Office of Chemical Safety and
Environmental Health, to ensure that any continued use does not pose a risk to users.
INSTRUCTIONS FOR DEALING WITH SUSPENDED ACTIVE CONSTITUENTS AND PRODUCTS
Unless authorised by the APVMA, the following instructions apply for persons having possession or custody of stocks,
and are considering using or otherwise dealing with suspended active constituent and product during the period of
Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 24
Other Notices - Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene
INSTRUCTIONS FOR POSSESSING, HAVING CUSTODY OF, USING OR DEALING WITH SUSPENDED ACTIVE
CONSTITUENTS AND PRODUCTS
Possession and custody
Possession and custody of existing stocks of quintozene active constituent and/or products is permitted.
Supply
No supply of the active constituent quintozene and/or any product that contains it as an active constituent is permitted.
Use
No use of suspended product containing quintozene is permitted.
Any person who possesses or has custody of, or otherwise deals with the active constituents or products listed in Tables
1 and 2 (above) in accordance with the instructions in this notice is taken to have been issued with a permit to possess,
have custody of, or deal with the active constituents or products during the period of suspension or until further notice.
WARNING
A person must not possess with the intent to supply, or deal with any materials containing quintozene during this period,
except in accordance with the instructions contained in this notice. A failure to comply with these instructions will result in
an offence against the Agvet Codes and the APVMA will take appropriate compliance action. It is an offence for any
person to possess with the intent to supply, use or deal with the active constituent after 9 April 2010 unless authorised to
do so by the APVMA. Similarly, it is an offence for any person to possess with the intent to supply, use or deal with
quintozene products after 12 April 2010, unless authorised to do so by the APVMA.
APVMA CONTACT
For further information please contact:
Contact Officer
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority