No. APVMA 16, Tuesday, 11 August 2015
Published by The Australian Pesticides and 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. A reference to Agvet Codes
in this publication is a reference to the Agvet Code in each state and territory jurisdiction.
ISSN 1837 - 7629
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
2
 Commonwealth of Australia 2015
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 Australian Pesticides and Veterinary Medicines Authority. Requests and
inquiries concerning reproduction and rights should be addressed to:
The Manager, Public Affairs and Communications
The Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Email: communications@apvma.gov.au
Website: www.apvma.gov.au.
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 grant ed 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 8J(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 activ ity in
quarterly statistical reports.
DISTRIBUTION AND SUBSCRIPTION
The APVMA Gazette is published in electronic format only and is available from the APVMA website,
www.apvma.gov.au/publications/gazette/.
If you would like to receive email notification when a new edition is published, please subscribe on the APVMA website.
APVMA CONTACTS
For enquiries regarding the publishing and distribution of the APVMA Gazette:
Telephone: +61 2 6210 4870
For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
3
CONTENTS
Errata .............................................................................................................................................................................. 3
Agricultural Chemical Products and Approved Labels..................................................................................................... 4
Veterinary Chemical Products and Approved Labels .................................................................................................... 10
Approved Active Constituents ....................................................................................................................................... 12
Appointment of Approved Analysts—Subsection 69G(2) of the Agricultural and Veterinary Chemicals (Administration)
Act 1992 ........................................................................................................................................................................ 13
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS............................................................................. 14
Buprenorphine in BUPREDYNE INJECTION ................................................................................................................ 21
Amendments to the APVMA MRL Standard.................................................................................................................. 28
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code ............................................ 29
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code ....................................................... 33
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations ............................... 40
Errata
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 14, Tuesday, 14 July 2015
In the Notice, the ‘Summary of use’ for Oxysept Agri Peroxyacetic Acid Sanitiser product 70095/62499 was incorrect.
The correct entry for the Notice of Registration for Oxysept Agri Peroxyacetic Acid Sanitiser is on page 4 of this Gazette.
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 15, 28 July 2015.
In the Notice, the Approved Analysts—Subsection 69G(2) of the Agricultural and Veterinary Chemicals (Administration)
Act 1992 the appointment numbers for the two new analysts were incorrectly reported.
The correct entry for the Notice of Appointment of Approved Analysts—Subsection 69G(2) of the Agricultural and
Veterinary Chemicals (Administration) Act 1992 is on page 13 of this Gazette.
The Australian Pesticides and Veterinary Medicines Authority advises that the notice published on page 12 in the
Commonwealth of Australia Gazette for Agricultural and Veterinary Chemicals, No. APVMA 15, Tuesday 28 July 2015
did not contain the attachments referred to in the notice.
The correct entry and attachment for the Notice of Inclusion of Active Constituent Approvals and Product Registration in
current Reconsiderations is on page 40 of this Gazette.
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
4
Agricultural Chemical Products and Approved Labels
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 relevant particulars or conditions of
the registration in respect of the following products and has approved the label or varied the relevant particulars or
conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1.
2.
RESTRICTED PRODUCT
Application no.:
102204
Product name:
Presor 45 EC Termiticide & Insecticide
Active constituent/s:
450 g/L chlorpyrifos (an anti-cholinesterase compound)
Applicant name:
Premier Shukuroglou Cyprus Ltd
Applicant ACN:
N/A
Summary of use
Date of registration/approval:
For the protection of structures from subterranean termite damage and for the control of termites
and a range of other urban pests
28 July 2015
Product registration no.:
81041
Label approval no.:
81041/102204
AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.:
62499
Product name:
Oxysept Agri Peroxyacetic Acid Sanitiser
Active constituent/s:
299 g/L hydrogen peroxide, 50 g/L peroxyacetic acid
Applicant name:
Ecolab Pty Limited
Applicant ACN:
000 449 990
Summary of use
For use as sanitiser on hard, non-porous surfaces on automated milking equipment
Date of registration/approval:
29 June 2015
Product registration no.:
70095
Label approval no.:
70095/62499
Application no.:
102028
Product name:
Baracuda Weekly Chlorine Tablets
Active constituent/s:
900 g/kg chlorine present as trichloroisocyanuric acid
Applicant name:
Zodiac Group Australia Pty Ltd
Applicant ACN:
002 641 965
Summary of use
For the control of bacteria, viruses and algae in swimming pools
Date of registration/approval:
22 July 2015
Product registration no.:
80979
Label approval no.:
80979/102028
Application no.:
102094
Product name:
Baracuda Salt Water Boost
Active constituent/s:
504 g/kg sodium dichlorisocyanurate; also contains 100 g/kg sodium tetraborate pentahydrate
Applicant name:
Zodiac Group Australia Pty Ltd
Applicant ACN:
002 641 965
Summary of use
For the control of bacteria and algae in outdoor swimming pools
Date of registration/approval:
22 July 2015
Product registration no.:
80998
Label approval no.:
80998/102094
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
5
Application no.:
101313
Product name:
R70 Spa Chlor
Active constituent/s:
350 g/kg available chlorine (Cl) present as lithium hypochlorite
Applicant name:
Pool Resources Pty Limited
Applicant ACN:
062 201 441
Summary of use:
Date of registration/approval:
For the control of bacteria, viruses and algae in spas and kills blackspot algae
23 July 2015
Product registration no.:
80633
Label approval no.:
80633/101313
Application no.:
101477
Product name:
Applicant name:
Apparent Ramjet 75-D Herbicide
300 g/L 2,4-D, present as the triisopropanolamine salt , 75 g/L picloram,
present as the triisopropanolamine salt
Apparent Pty. Ltd
Applicant ACN:
143 724 136
Summary of use:
For the control of a wide range of annual and perennial broadleaf weeds
Date of registration/approval:
23 July 2015
Product registration no.:
80713
Label approval no.:
80713/101477
Application no.:
100836
Product name:
Sinochem Flumetsulam 800 WG Herbicide
Active constituent/s:
800 g/kg flumetsulam
Applicant name:
Sinochem Agro Co., Ltd
Applicant ACN:
N/A
Summary of use:
For the control of pre-emergence control of certain broadleaf weeds in maize and soybeans
Date of registration/approval:
24 July 2015
Product registration no.:
80422
Label approval no.:
80422/100836
Application no.:
102270
Product name:
Weedstrike 100 Non-Selective Herbicide
Active constituent/s:
100 g/L glyphosate present as the isopropylamine salt
Applicant name:
Loral Ipsum (Aust) Pty. Ltd
Applicant ACN:
103 393 255
Summary of use:
Date of registration/approval:
For the control of weeds
27 July 2015
Product registration no.:
81073
Label approval no.:
81073/102270
Application no.:
102199
Product name:
Surefire Pro Cockroach Gel Bait
Active constituent/s:
0.5 g/kg fipronil
Applicant name:
PCT Holdings Pty Ltd
Applicant ACN:
099 023 962
Summary of use:
For the treatment of cockroach infestations in urban situations
Date of registration/approval:
28 July 2015
Product registration no.:
81036
Label approval no.:
81036/102199
Active constituent/s:
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
6
Application no.:
101780
Product name:
Crossbar 240 Selective Herbicide
Active constituent/s:
240 g/L oxyfluorfen
Applicant name:
UPL Australia Limited
Applicant ACN:
066 391 384
Summary of use
Date of registration/approval:
For the selective control of certain broadleaf and grass weeds in various situations
28 July 2015
Product registration no.:
80849
Label approval no.:
80849/101780
Application no.:
63397
Product name:
Accensi 2,4-D Amine 700 Dual Selective Herbicide
Active constituent/s:
700 g/L 2,4-D present as dimethylamine and diethanolamine salts
Applicant name:
Accensi Pty Ltd
Applicant ACN:
Date of registration/approval:
079 875 184
For the control of broadleaf weeds in fallow before direct drilling or sowing of cereals and
pastures; and in cereal crops, pastures, sugar cane, peanutsand non-agricultural areas
28 July 2015
Product registration no.:
70408
Label approval no.:
70408/63397
Application no.:
102083
Product name:
Baracuda Xtreme Shock
Active constituent/s:
700 g/kg available chlorine (Cl) present as calcium hypochlorite
Applicant name:
Zodiac Group Australia Pty Ltd
Applicant ACN:
002 641 965
Summary of use:
For controlling bacteria and algae in swimming pools
Date of registration/approval:
30 July 2015
Product registration no.:
80991
Label approval no.:
80991/102083
Application no.:
102240
Product name:
4Farmers Amitrole 250 Herbicide
Active constituent/s:
250 g/L amitrole
Applicant name:
4 Farmers Australia Pty Ltd
Applicant ACN:
160 092 428
Summary of use:
Date of registration/approval:
For the control of weeds in orchards, vineyards, irrigation ditches and drains, eucalyptus and
pine plantations, roadsides, pre-plant wheat and barley, and for general industrial situations
30 July 2015
Product registration no.:
81051
Label approval no.:
81051/102240
Application no.:
102344
Product name:
AC Petulant 250 EC Fungicide
Active constituent/s:
250 g/L Propiconazole
Applicant name:
Axichem Pty Ltd
Applicant ACN:
131 628 594
Summary of use:
Date of registration/approval:
For the control of certain fungal diseases of bananas, peanuts, pineapples, stone fruit, sugar
cane, wheat and other crops in certain states
30 July 2015
Product registration no.:
81115
Label approval no.:
81115/102344
Summary of use:
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
3.
Agricultural and Veterinary Chemicals Code Act 1994
7
Application no.:
101074
Product name:
Bachlor 125 SC Fungicide
Active constituent/s:
125 g/L epoxiconazole
Applicant name:
AAKO Australia Pty Limited
Applicant ACN:
122 279 109
Summary of use
Date of registration/approval:
For the control of leaf rust, stripe rust, septoria nodorum blotch and powdery mildew of wheat,
leaf rust, net form of net blotch, leaf scald and powdery mildew of barley and leaf spot and leaf
speckle in bananas
3 August 2015
Product registration no.:
80541
Label approval no.:
80541/101074
VARIATIONS OF REGISTRATION
Application no:
103312
Product name:
Methograin Fenitrothion 1000 Insecticide
Active constituent/s:
1000 g/L fenitrothion
Applicant name:
Babolna Bioenvironmental Centre Ltd
Applicant ACN:
Date of variation:
N/A
To change the distinguishing product name and the name that appears on the label from
‘RENTOKIL FENITROTHION 1000 INSECTICIDE’ to ‘METHOGRAIN FENITROTHION 1000
INSECTICIDE’
21 July 2015
Product registration no.:
46127
Label approval no.:
46127/103312
Application no:
103313
Product name:
Methograin IGR Grain Protectant
Active constituent/s:
30 g/L (s)-methoprene
Applicant name:
Babolna Bioenvironmental Centre Ltd
Applicant ACN:
Date of variation:
N/A
To change the distinguishing product name and the name that appears on the label from
‘RENTOKIL IGR GRAIN PROTECTANT’ to ‘METHOGRAIN IGR GRAIN PROTECTANT’
21 July 2015
Product registration no.:
53038
Label approval no.:
53038/103313
Application no:
103314
Product name:
Methograin IGR 300 Grain Protectant
Active constituent/s:
300 g/L (s)-methoprene
Applicant name:
Babolna Bioenvironmental Centre Ltd
Applicant ACN:
Date of variation:
N/A
To change the distinguishing product name and the name that appears on the label from
‘RENTOKIL IGR 300 GRAIN PROTECTANT’ to ‘METHOGRAIN IGR 300 Grain Protectant’
21 July 2015
Product registration no.:
61969
Label approval no.:
61969/103314
Summary of variation:
Summary of variation:
Summary of variation:
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
8
Application no:
102279
Product name:
Nail 600EC Herbicide
Active constituent/s:
600 g/L carfentrazone-ethyl
Applicant name:
Crop Care Australasia Pty Ltd
Applicant ACN:
061 362 347
Summary of variation:
To amend the solvent statement on the label
Date of variation:
23 July 2015
Product registration no.:
69772
Label approval no.:
69772/102279
Application no:
103366
Product name:
Monaco Herbicide
Active constituent/s:
750 g/kg sulfosulfuron
Applicant name:
Crop Culture Pty Ltd
Applicant ACN:
Date of variation:
142 860 473
To change the distinguishing name and the name that appears on the label from ‘CROP
CULTURE MONACO HERBICIDE’ to ‘MONACO HERBICIDE’
27 July 2015
Product registration no.:
68230
Label approval no.:
68230/103366
Application no:
102072
Product name:
Steer 750 Herbicide
Active constituent/s:
750 g/kg quinclorac
Applicant name:
Turf Culture Pty Ltd
Applicant ACN:
117 986 615
Summary of variation:
To change the product name from ‘TURF CULTURE STEER 750 HERBICIDE’ to
‘STEER 750 HERBICIDE’ and add a pack range from 1 kg–10 kg
Date of variation:
28 July 2015
Product registration no.:
70424
Label approval no.:
70424/102072
Application no:
102074
Product name:
Unimaz 250 SL Herbicide
Active constituent/s:
250 g/L imazapyr present as isopropylamine salt
Applicant name:
UPL Australia Limited
Applicant ACN:
066 391 384
Summary of variation:
To amend the label to include lockable irrigation channels in settling ponds
Date of variation:
28 July 2015
Product registration no.:
63546
Label approval no.:
63546/102074
Application no:
103380
Product name:
Mortein Peaceful Nights Mosquito and Fly Repellent
Active constituent/s:
99 g/L transfluthrin
Applicant name:
Reckitt Benckiser (Australia) Pty Limited
Applicant ACN:
Date of variation:
003 274 655
To change the distinguishing product name and the name that appears on the label from
‘MORTEIN PEACEFUL NIGHTS MOZZIE ZAPPER UP TO 30 NIGHTS PROTECTION AGAINST
MOSQUITOES and FLIES ODOURLESS’ to ‘MORTEIN PEACEFUL NIGHTS MOSQUITO AND
FLY REPELLENT’
28 July 2015
Product registration no.:
68926
Label approval no.:
68926/103380
Summary of variation:
Summary of variation:
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
9
Application no:
102145
Product name:
Rotary Max Herbicide
Active constituent/s:
240 g/L imazapyr present as isopropylamine salt
Applicant name:
Adama Australia Pty Limited
Applicant ACN:
050 328 973
Summary of variation:
To amend the current uses to include irrigation channels and add the control of rubber vine and
thumbergia
Date of variation:
29 July 2015
Product registration no.:
65787
Label approval no.:
65787/102145
Application no:
102184
Product name:
Merit Turf and Ornamental Insecticide
Active constituent/s:
200 g/L imidacloprid
Applicant name:
Bayer CropScience Pty Ltd
Applicant ACN:
000 226 022
Summary of variation:
To change the pack range to 1 L–5 L
Date of variation:
31 July 2015
Product registration no.:
59696
Label approval no.:
59696/102184
Application no:
102552
Product name:
Alkaforce Soluble Concentrated C.I.P. Alkaline Detergent
Active constituent/s:
125 g/L potassium hydroxide, 375 g/L sodium hydroxide
Applicant name:
Dasco Proprietary Limited
Applicant ACN:
004 581 113
Summary of variation:
To add an additional label name to the product ‘GUARD 100 SOLUBLE CONCENTRATED C.I.P.
ALKALINE DETERGENT’ for cleaning milking machines and bulk tanks
Date of variation:
3 August 2015
Product registration no.:
70056
Label approval no.:
70056/102552
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
10
Veterinary Chemical Products and Approved Labels
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 relevant particulars or conditions of
the registration in respect of the following products and has approved the label or varied the relevant particulars or
conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1.
2.
VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.:
60898
Product name:
Carbidox 1000
Active constituent/s:
980 g/kg nicarbazin
Applicant name:
Dox-al Australia Pty Ltd
Applicant ACN:
079 454 265
Summary of use:
For the prevention of coccidiosis in broiler chickens
Date of registration/approval:
24 July 2015
Product registration no.:
67009
Label approval no.:
67009/60989
Application no.:
102097
Product name:
IO Independents Own Pig and Poultry Wormer
Active constituent/s:
14 g/L levamisole (equivalent to 16.5 g/L levamisole hydrochloride)
Applicant name:
C M Laboratories Pty Ltd
Applicant ACN:
098 897 637
Summary of use
Oral solution product for the treatment of sensitive strains of roundworms in pigs and poultry
Date of registration/approval:
27 July 2015
Product registration no.:
81000
Label approval no.:
81000/102097
Application no.:
102239
Product name:
Independents Own Fenbender 100 Oral Drench for Cattle and Horses
Active constituent/s:
100 g/L fenbendazole
Applicant name:
Apparent Pty. Ltd
Applicant ACN:
143 724 136
Summary of use
For the control of benzimidazole sensitive mature and immature roundworms (including inhibited
Ostertagia), lungworms and as an aid in the control of tape worms in cattle. For the treatment
and control of roundworms, bloodworms, redworms and pinworms in horses
Date of registration/approval:
29 July 2015
Product registration no.:
81050
Label approval no.:
81050/102239
VARIATIONS OF REGISTRATION
Application no.:
103352
Product name:
Advantage Drontal for Cats Allwormer Tablet
Active constituent/s:
80 mg/tb pyrantel as pyrantel embonate, 20 mg/tb praziquantel
Applicant name:
Bayer Australia Ltd (Animal Health)
Applicant ACN:
Date of variation:
000 138 714
To change the distinguishing name and the name that appears on the label from ‘VETS
CHOICE FOR CAT ALLWORMER TABLET’ to ‘ADVANTAGE DRONTAL FOR CATS
ALLWORMER TABLET’
24 July 2015
Product registration no.:
80141
Label approval no.:
80141/103352
Summary of variation:
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
11
Application no.:
103350
Product name:
Advantage Drontal for Large Cats Allwormer Tablet
Active constituent/s:
120 mg/tb pyrantel as pyrantel embonate, 30 mg/tb praziquantel
Applicant name:
Bayer Australia Ltd (Animal Health)
Applicant ACN:
Date of variation:
000 138 714
To change the distinguishing product name and the name that appears on the label from ‘VETS
CHOICE FOR LARGE CATS ALLWORMER TABLET’ to ‘ADVANTAGE DRONTAL FOR
LARGE CATS ALLWORMER TABLET’
24 July 2015
Product registration no.:
80143
Label approval no.:
80143/103350
Summary of variation:
3.
Agricultural and Veterinary Chemicals Code Act 1994
VARIATION OF LABEL APPROVAL
Application no.:
101040
Product name:
Vetmedin 1.25 MG Chewable Tablets for Dogs
Active constituent/s:
each tablet contains 1.25 mg pimobendan
Applicant name:
Boehringer Ingelheim Pty Limited, Vetmedica Division
Applicant ACN:
000 452 308
Summary of variation:
To update the claims to include use in large breed dogs with preclinical DCM
Date of variation:
23 July 2015
Product registration no.:
60800
Label approval no.:
60800/101040
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Approved Active Constituents
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 approved or varied the relevant particulars or conditions of
the approval of the following active constituents, with effect from the dates shown.
1.
ACTIVE CONSITUTENT
Application no.:
101047
Active constituent/s:
Dicamba
Applicant name:
Adama Australia Pty Limited
Applicant ACN:
050 328 973
Summary of use:
For use in agricultural chemical products
Date of approval:
22 July 2015
Approval no.:
80526
Application no.:
100165
Active constituent/s:
Florasulam
Applicant name:
Dow AgroSciences Australia Limited
Applicant ACN:
003 771 659
Summary of use:
For use in agricultural chemical products
Date of approval:
29 July 2015
Approval no.:
80078
Approved Active Constituents
12
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
13
Appointment of Approved Analysts—Subsection 69G(2) of the Agricultural and Veterinary
Chemicals (Administration) Act 1992
Notice is hereby given that the persons described in Schedule 1 below were duly appointed on 14 July 2015 in
accordance with subsection 69G (1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992, as approved
analysts for the purposes of the Agvet Code.
Schedule 1
Appointment Number: AN087
Dr Rama Nimmagadda
Advanced Analytical Australia Pty Ltd
11 Julius Ave, North Ryde NSW
02 9888 9077
Appointment Number: AN088
Dr Mark Lewin
Advanced Analytical Australia Pty Ltd
11 Julius Ave, North Ryde NSW
02 9888 9077
APVMA CONTACT
Compliance and Monitoring
Legal and Compliance Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Phone: +61 2 6210 4821
Fax:
+61 2 6210 4813
Email: compliance@apvma.gov.au
Appointment of Approved Analysts—Subsection 69G(2) of the Agricultural and Veterinary Chemicals (Administration) Act 1992
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
14
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from BOEHRINGER
INGELHEIM PTY LIMITED, VETMEDICA DIVISION for the approval of a new active constituent telmisartan. The APVMA
also has before it an application from the same applicant for the registration of a new product containing the new active
constituent. SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS is for the reduction of proteinuria in cats with chronic
kidney disease.
PARTICULARS OF THE ACTIVE CONSTITUENT
Common Name:
Telmisartan
IUPAC Name:
2-(4-{[4-methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1yl]methyl}phenyl)benzoic acid
CAS Name:
[1,1'-Biphenyl]-2-carboxylic acid, 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]1'-yl)methyl]-
CAS Registry Number:
144701-48-4
Manufacturer’s Codes:
BIBR 277 SE
Minimum Purity:
99.0%
Molecular Formula:
C33H30N4O2
Molar Mass:
514.6
Structure:
Chemical Family:
Benzimidazole
Mode of Action:
Non-peptide angiotensin II receptor with high affinity for angiotensin receptor type 1.
It is used to reduce proteinuria associated with chronic kidney disease.
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
15
SUMMARY OF THE APVMA’S EVALUATION OF THE ACTIVE CONSTITUENT TELMISARTAN IN ACCORDANCE
WITH SECTION 5A 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 new active constituent telmisartan under sections 5A(1)(a),(b) and (c) of the Agvet Code
and proposes to be satisfied that the active constituent is not, or would not: be an undue hazard to the safety of people
exposed to it during its handling or people using anything containing its residues; be likely to have an effect that is harmful
to human beings; or be likely to have an unintended effect that is harmful to animals, plants or things or to the environment.
The APVMA has evaluated the chemistry and manufacturing aspects of telmisartan in SEMINTRA 4MG/ML ORAL
SOLUTION FOR CATS through data provided by the applicant (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) and is satisfied that the safety criteria relevant to the
approval of the active constituent and registration of the product have been met.
An external toxicologist has conducted a risk assessment and found that the submitted data supports the safe use of the
product from a toxicological perspective.
Results of the dermal tolerance studies did not reveal the active ingredient to be a skin irritant, and acute oral toxicity
studies on the active ingredient indicated low acute oral toxicity. Mild, reversible eye irritation was observed in an eye
irritation study which may have been due to the mechanical properties of the powder. In the absence of skin sensitisation
data on either the product or active ingredient the reviewer considered other data on drugs of this class (angiotensin ll
receptor antagonists) no evidence was found that they have skin sensitising potential.
Nonclinical studies have shown that telmisartan crosses the placenta. Although telmisartan was not found to be
teratogenic in the nonclinical studies and although there is no clinical experience with telmisartan in pregnant women, in
utero exposure to drugs that act directly on the renin-angiotensin system can cause foetal and neonatal morbidity and
even death. Angiotensin II receptor antagonist exposure during the second and third trimesters is known to induce
human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal
failure, hypotension, hyperkalaemia). These adverse effects do not appear to occur when drug exposure has been
limited to the first trimester.
As the product is to be used only in cats, telmisartan is unlikely to enter the food chain and therefore the determination of
an Acceptable Daily Intake, Acute Reference Dose and Maximum Residue Limits are not considered necessary.
Telmisartan is listed on the TGA’s Australian Register of Therapeutic Goods (ARTG) for use in humans as tablets (40 mg
and 80 mg) for the treatment of the hypertension and the prevention of cardiovascular morbidity and mortality in patients
with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes
with evidence of end organ damage. Telmisartan is approved for therapeutic use in humans, and is listed in Schedule 4
of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) with no exceptions. Semintra 4 mg/mL
Oral Solution for Cats is classified as a Schedule 4 prescription animal remedy. Based on the concentration of
telmisartan and the toxicology profile of the product, this classification is considered appropriate. The appropriate
Schedule 4 signal heading and the first aid instructions and safety directions will appear on the product label.
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
16
PARTICULARS OF SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS APPLICATION
Proposed Product Name(s):
SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
Applicant Company:
BOEHRINGER INGELHEIM PTY LIMITED, VETMEDICA DIVISION
Name of Active Constituent:
Telmisartan
Signal Heading:
Prescription Animal Remedy - Schedule 4
Summary of Proposed Use:
For the reduction of proteinuria in cats with chronic kidney disease.
Pack Sizes:
30 mL
Withholding Period:
N/A
SUMMARY OF THE APVMA’S EVALUATION OF SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS IN
ACCORDANCE WITH SECTION 5A, 5B AND 5C OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE
(THE ‘AGVET CODE’), SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994
1.
The APVMA has evaluated the product and in its assessment in relation to human and environmental safety under
section 5A(1)(a),(b) and (c) and 5C(1) of the Agvet Code, it proposes to determine that:
(i)
The APVMA is satisfied that the proposed use of SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
would not be an undue hazard to the safety of people exposed to it during its handling (section 5A(1)(a)).
No toxicity studies conducted on the formulated product were submitted. Product toxicity has been
estimated based on available data for the active ingredient and the excipients. The product has been
determined to be of low acute oral toxicity, is not expected to be an acute dermal irritant, could possibly be
a slight eye irritant, and is unlikely to have skin sensitising potential. Based on these acute hazards the
external reviewer has recommended that first aid instructions and safety directions appear on the product
labelling. Further, given the adverse findings seen following exposure in pregnant women to drugs that act
directly on the renin-angiotensin system, an additional user safety statement has been recommended. The
proposed label statements are as follows:
FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 13 11 26;
New Zealand 0800 764 766.
SAFETY DIRECTIONS May be harmful if swallowed. May irritate the eyes. Avoid contact with eyes. Wash
hands after use.
Additional user safety: Pregnant women should use gloves when handling and administering Semintra
4 mg/mL oral solution for cats.
The APVMA has considered and accepted the findings and recommendations of the external reviewer.
(ii)
The APVMA is satisfied that the proposed use of SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS will
not be an undue hazard to the safety of people using anything containing their residues (section 5A(1)(a)).
The product is for use on cats only. Telmisartan is unlikely to enter the food chain and therefore the
determination of an Acceptable Daily Intake, Acute Reference Dose and Maximum Residue Limits are not
considered necessary.
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
(iii)
Agricultural and Veterinary Chemicals Code Act 1994
17
The APVMA is satisfied that the proposed use of SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
containing the active constituent telmisartan is not likely to be harmful to human beings (section 5A(1)(b)) if
used according to SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS label directions.
Telmisartan is listed on the TGA’s Australian Register of Therapeutic Goods (ARTG) for use in humans as
tablets (40 mg and 80 mg) for the treatment of the hypertension and the prevention of cardiovascular
morbidity and mortality in patients with coronary artery disease, peripheral artery disease, previous stroke,
transient ischaemic attack or high risk diabetes with evidence of end organ damage. Telmisartan is approved
for therapeutic use in humans, and is listed in Schedule 4 of the Standard for the Uniform Scheduling of
Medicines and Poisons (SUSMP) with no exceptions. Semintra 4 mg/mL Oral Solution for Cats is classified
as a Schedule 4 prescription animal remedy. Based on the concentration of telmisartan and the toxicology
profile of the product, this classification is considered appropriate. The appropriate Schedule 4 signal heading
and the first aid instructions and safety directions will appear on the product label.
2.
The APVMA has evaluated the product and in its assessment in relation to environmental safety under section 5A(1)(c)
of the Agvet Code, it proposes to determine that:
(i)
The APVMA is satisfied that the proposed use of SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
containing the active constituent telmisartan would not be likely to have an unintended effect that is harmful
to animals, plants or things or the environment if used according to SEMINTRA 4MG/ML ORAL SOLUTION
FOR CATS label directions.
The Department of the Environment has evaluated the environmental aspects of SEMINTRA 4MG/ML
ORAL SOLUTION FOR CATS and has advised that the product meets the criteria for the environmental
risk assessment to stop at VICH Phase I (where the potential for environmental exposure is assessed
based on the intended use of the product—in this case for companion animals only). The Department of the
Environment has recommended to the APVMA that the use of the product on cats under the proposed use
pattern is unlikely to have an unintended effect that is harmful to the environment. The APVMA has
considered these findings and accepts the recommendations of the Department of the Environment. The
product labels will contain a suitable disposal statement.
3.
The APVMA has evaluated the product and in its assessment in relation to whether the trade criterion has been met
in accordance with section 5C(1) of the Agvet Code, it proposes to determine that:
(i)
The APVMA is satisfied that the proposed use of SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
would not unduly prejudice trade or commerce between Australia and places outside Australia as
SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS is for use in cats, which are not food-producing
animals nor do they produce any major Australian export commodities.
4.
The APVMA has evaluated the product and in its assessment in relation to target animal safety under section
5A(1)(c) of the Agvet Code, it proposes to determine that:
(i)
The APVMA is satisfied that SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS if used according to
SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS label directions, is not, or would not be, likely to have
an unintended effect that is harmful to animals.
An external reviewer evaluated the data provided and found that the submitted data supports the safety of
the proposed product when used for the reduction of proteinuria in cats with chronic kidney disease.
A margin of safety study was conducted to evaluate the safety SEMINTRA 4MG/ML ORAL SOLUTION
FOR CATS when administered once daily for 6 months to adult cats at 0, 1, 3 and 5 times the maximum
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
18
daily targeted dose. The target animal safety study used 40 cats (20 male and 20 female). Cats were
randomly allocated to 5 groups receiving: placebo, 1, 3, and 5 mg/kg orally once a day for 183 days. Study
observations were blinded. Expected pharmacological effects of lower blood pressure were noted from
week four in the 1mg group, week 2 in the 3mg group and the first week in the 5mg group, when compared
with the placebo group.
Test article related lower food consumption was observed in the 3 and 5 mg group females compared to
the placebo group. Minimal to mild hypertrophy of the juxtaglomerular apparatus of the kidney was
observed in the 1, 3 and 5 mg groups. This is consistent with renin cells as the target cell population of the
test article and the pharmacologic response to blockage of the angiotensin II receptors. Although expected
pharmacological effects were observed, adverse test article effects on the erythron, heart organ weight and
serum chemistry were observed, especially in females, and the NOAEL is therefore 3 mg/kg orally once a
day for 183 days. This represents a 3 x safety margin for the proposed product administered as directed for
6 months in cats. The data supports the safety of the proposed product administered as directed to cats
greater 8 months old for 6 months.
The APVMA has considered these findings and accepts the recommendations of the external reviewer. Any
adverse effects noted in the margin of safety study and the clinical efficacy studies were used to create
label statements on side effects. As the safety of telmisartin in breeding, pregnant and lactating cats or in
cats under 6 months of age has not been established, a label statement reflecting this will be included on
the label.
5.
The APVMA has evaluated the product and in its assessment in relation to efficacy under section 5B(1) of the Agvet
Code, it proposes to determine that:
(i)
The APVMA is satisfied that SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS if used according to
SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS label directions, would be effective when used for the
reduction of proteinuria in cats with chronic kidney disease.
An external reviewer evaluated the data provided and found that the submitted data supports the efficacy of
the proposed product when used for the reduction of proteinuria in cats with chronic kidney disease. The
proposed dose rate is 1 mg/kg bodyweight per day. In addition to published studies from the literature, the
pivotal studies provided to support the efficacy of the product included pharmacokinetic data, dose
determination, dose confirmation and clinical efficacy studies.
Following oral administration telmisartan is rapidly absorbed, achieving maximum plasma concentration
after 30 minutes. Telmisartan is highly lipophilic which facilitates easy distribution into tissue. Based on the
area under the curve and maximum concentration data, exposure was found to be generally higher for
females than for males. Food consumption does not affect the overall extent of absorption of telmisartan.
Telmisartan is effectively glucuronidated in the cat. After oral administration, telmisartan is almost
exclusively excreted with faeces mainly as unchanged compound.
The dose determination and confirmation studies supported the proposed dose rate of 1 mg/kg bodyweight
per day. A confirmatory clinical study was conducted to demonstrate the efficacy of telmisartan compared
to benazepril in controlling proteinuria in cats with chronic kidney disease. The study used 224 cats
between 2–22 years of age of multiple breeds with clinical evidence of chronic kidney disease. This study
was a blinded, multi-centre, parallel-group, positive-controlled, prospective, randomised clinical study in
client-owned cats. Cats were randomly allocated to treatment groups and observers were blinded to
treatment group. Dispensed outer packs looked the same and were adjusted to the same weight. The
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
19
dosing regimen used was telmisartan at 0.25 mL/kg BW once a day (equivalent to 1 mg/kg telmisartan
orally once a day).
The Mean Urine Protein:Creatine ratio (UP:C) was decreased in both groups at 180 days compared to
baseline. Mean urine protein decreased in the telmisartan group compared to baseline and this was
statistically significant (p<0.05) for all time points except at 120 days. The effect of Telmisartan on UP:C
was non-inferior to that of benazepril, as the 95% confidence interval of the adjusted mean differences of
the primary variable lies entirely above the non-inferiority margin. Around 30% of cats in each group
showed a decrease from borderline proteinuria to non-proteinuric during the course of the study. This effect
was more pronounced in the telmisartan group where more cats showed the decrease.
Adverse reactions attributable to the product were found to be rare; though gastrointestinal signs such as
mild and intermittent regurgitation, vomiting, diarrhoea or soft faeces can occur. Elevated liver enzymes
were very rarely observed and values normalized within a few days following cessation of therapy. Effects
attributable to the pharmacological activity of the product on the Renin-Angiotensin-Aldosterone System
(RAAS), observed at the recommended treatment dose, included reductions in blood pressure and
decreases in red blood cell counts.
The data supports the safety of the proposed formulation at 1 mg/kg orally once a day in cats with chronic
kidney disease for up to 180 days. The safety profile is comparable with benazepril (used as directed). The
data supports the non-inferiority of the applicant formulation, compared to benazepril (used as directed), in
the reduction of UP:C in cats with chronic kidney disease when administered at 1 mg/kg orally once a day
for up to 180 days. No significant drug incompatibilities were noted.
The APVMA has considered these findings and accepts the recommendations of the external reviewer.
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 active telmisartan should be approved and whether the application for registration of the
product SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS should be granted. Submissions should relate only to
matters that the APVMA is required by legislation to take into account in deciding whether to approve the active or grant
the registration application for SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS. These grounds include: for approval
of the active constituent, the safety criteria. For the registration applications for SEMINTRA 4MG/ML ORAL SOLUTION
FOR CATS: the safety, efficacy and trade criteria. 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 active constituent should be
approved and whether SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS should be registered and in determining
appropriate conditions of registration and product labelling.
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
20
When making a submission please include:




contact name
company or group name (if relevant)
email or postal address
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 approve the active constituent and grant the application for registration
that relate to the grounds for active approval and/or product registration should be addressed in writing to:
Enquiries
Registration Management and Evaluation
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4700
Fax:
+61 2 6210 4741
Email: enquiries@apvma.gov.au
1
A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
21
Buprenorphine in BUPREDYNE INJECTION
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Jurox Pty Ltd
for the approval of a new active constituent buprenorphine. The APVMA also has before it an application from the same
applicant for the registration of a new product, BUPREDYNE INJECTION, containing the new active constituent.
BUPREDYNE INJECTION is proposed to be registered as an analgesic injection for use in dogs and cats.
PARTICULARS OF THE ACTIVE CONSTITUENT
Common Name:
Buprenorphine hydrochloride
IUPAC Name:
(2S)-2-[17-(Cyclopropylmethyl)-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14αmorphinan-7α-yl]- 3,3-dimethylbutan-2-ol hydrochloride
CAS Name:
[αS, 5α,7α]-17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3hydroxy-6-methoxy-α-methyl- 6,14-Ethenomorphinan-7-methanol, hydrochloride (1:1)
CAS Registry Number:
53152-21-9
Manufacturer’s Codes:
n/a
Minimum Purity:
98.5% (w/w)
Molecular Formula:
C29H42ClNO4
Molar Mass:
504.1
Structure:
Chemical Family:
opioids
Mode of Action:
opioid receptor partial agonist
SUMMARY OF THE APVMA’S EVALUATION OF THE ACTIVE CONSTITUENT BUPRENORPHINE IN
ACCORDANCE WITH SECTION 5A 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 new active constituent buprenorphine under sections 5A(1)(a),(b) and (c) of the Agvet Code
and proposes to be satisfied that the active constituent is not, or would not: be an undue hazard to the safety of people
exposed to it during its handling or people using anything containing its residues; be likely to have an effect that is harmful
to human beings; or be likely to have an unintended effect that is harmful to animals, plants or things or to the environment.
The APVMA has evaluated the chemistry and manufacturing aspects of buprenorphine in BUPREDYNE INJECTION
through data provided by the applicant (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) and is satisfied that the safety criteria relevant to the approval of the active
constituent and registration of the product have been met.
Buprenorphine in BUPREDYNE INJECTION
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
22
The Office of Chemical Safety (OCS) in the Department of Health has evaluated the toxicological profile of
buprenorphine through data provided by the applicant. Based on available data, buprenorphine has been reported to
have moderate oral toxicity in mice and low oral toxicity in rats. Buprenorphine is approximately an order of magnitude
less potent when administered orally compared with intravenous administration, indicating poor systemic oral
bioavailability. Systemic bioavailability of buprenorphine is increased when administered by intramuscular or intravenous
injection.
Distribution studies in rats soon after intravenous (IV) or intramuscular (IM) dosing have shown tissues with the highest
buprenorphine-related residue levels are fat, lung, heart, kidney, liver and brain. Buprenorphine readily crosses the
blood-brain barrier, and most of this is the unchanged drug. The major oxidative metabolite, norbuprenorphine, probably
because of its much lower lipophilicity, has limited distribution into the brain. Buprenorphine is able to cross the placenta.
After IM administration of radiolabelled buprenorphine, levels of radioactivity in plasma (total and free) and selected
tissues of pregnant and non-pregnant female rats were similar, indicating a similar buprenorphine distribution irrespective
of pregnancy state. Additional distribution investigations indicated that buprenorphine is highly bound to plasma proteins.
Buprenorphine was noted to induce a dose-related statistically significant increase in foetal mortality, and decrease body
weight gain in pups exposed to buprenorphine during the post-natal period. However, developmental milestones were
generally unaffected by treatment.
As the product is to be used only in dogs and cats, buprenorphine is unlikely to enter the food chain and therefore the
determination of an Acceptable Daily Intake, Acute Reference Dose and Maximum Residue Limits are not considered
necessary.
Buprenorphine is currently included in Schedule 8 of the Standard for the Uniform Scheduling of Medicines and Poisons
(SUSMP) with no cut-offs or exceptions. Buprenorphine is also listed in Appendix K of the SUSMP (chemicals that require
a sedation warning). The currently listings for buprenorphine were determined to be appropriate for this product. The
appropriate Schedule 8 signal heading and first aid instructions and safety directions will appear on the product label.
The APVMA has considered and accepted the findings and recommendations of the advice providers.
PARTICULARS OF THE PRODUCT BUPREDYNE INJECTION
Proposed Product Name(s):
BUPREDYNE INJECTION
Applicant Company:
Jurox Pty Limited
Name of Active Constituent:
Buprenorphine hydrochloride
Signal Heading:
Controlled Drug - Schedule 8
Summary of Proposed Use:
An analgesic injection for use in dogs and cats.
Pack Sizes:
10 mL
Withholding Period:
N/A
SUMMARY OF THE APVMA’S EVALUATION OF BUPREDYNE INJECTION IN ACCORDANCE WITH SECTION 5A,
5B AND 5C OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (THE ‘AGVET CODE’), SCHEDULED
TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994
1.
The APVMA has evaluated the product and in its assessment in relation to human and environmental safety under
section 5A(1)(a),(b) and (c) and 5C(1) of the Agvet Code, it proposes to determine that:
Buprenorphine in BUPREDYNE INJECTION
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
(i)
Agricultural and Veterinary Chemicals Code Act 1994
23
The APVMA is satisfied that the proposed use of BUPREDYNE INJECTION would not be an undue hazard
to the safety of people exposed to it during its handling (section 5A(1)(a)).
The Office of Chemical Safety (OCS) in the Department of Health has conducted a risk assessment and
found that the submitted data support the safe use of the product from a toxicological perspective.
Based on the formulation composition of the product, the product is expected to have low acute oral toxicity
(by estimation). No other data on acute dermal and inhalational toxicity endpoints were available, and no
irritancy or sensitisation data were available. However, noting that the product is for injection only, acute
dermal, inhalational and ocular exposures are not considered to be likely under normal conditions of
product use.
Buprenorphine was noted to induce a dose-related statistically significant increase in foetal mortality, and
decrease body weight gain in pups exposed to buprenorphine during the post-natal period. However,
developmental milestones were generally unaffected by treatment. It is noted that buprenorphine is
contraindicated for use during pregnancy and lactation, therefore precautionary statements to this effect
must be included on the product label.
Based on these findings the OCS has recommended that the following first aid instructions, safety
directions and precautionary statement appear on the product labelling:
FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 13 11 26.
If poisoning occurs, get to a doctor or hospital quickly.
SAFETY DIRECTIONS Avoid contact with eyes and skin. Wash hands after use.
Precautionary Statement: Buprenorphine is listed as a TGA Pregnancy Category C chemical (Drugs which,
owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the
human foetus or neonate without causing malformation. These effects may be reversible). Appropriate
precautions to minimise exposure to buprenorphine during use are recommended. For animal treatment
only.
The APVMA has considered and accepted the findings and recommendations of the OCS.
(ii)
The APVMA is satisfied that the proposed use of BUPREDYNE INJECTION will not be an undue hazard to
the safety of people using anything containing their residues (section 5A(1)(a)).
The product is for use on companion animals (dogs and cats) only. Buprenorphine is unlikely to enter the
food chain and therefore the determination of an Acceptable Daily Intake, Acute Reference Dose and
Maximum Residue Limits are not considered necessary.
(iii)
The APVMA is satisfied that the proposed use of BUPREDYNE INJECTION containing the active
constituent buprenorphine is not likely to be harmful to human beings (section 5A(1)(b)) if used according to
BUPREDYNE INJECTION label directions.
Buprenorphine is currently included in Schedule 8 of the SUSMP with no cut-offs or exceptions.
Buprenorphine is also listed in Appendix K of the SUSMP (chemicals that require a sedation warning). The
currently listings for buprenorphine were determined to be appropriate for this product. The appropriate
Schedule 8 signal heading and first aid instructions and safety directions will appear on the product label.
Buprenorphine in BUPREDYNE INJECTION
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
2.
Agricultural and Veterinary Chemicals Code Act 1994
24
The APVMA has evaluated the product and in its assessment in relation to environmental safety under section 5A(1)(c)
of the Agvet Code, it proposes to determine that:
(i)
The APVMA is satisfied that the proposed use of BUPREDYNE INJECTION containing the active
constituent buprenorphine would not be likely to have an unintended effect that is harmful to animals, plants
or things or the environment if used according to BUPREDYNE INJECTION label directions.
The Department of the Environment has evaluated the environmental aspects of BUPREDYNE INJECTION
and has advised that the product meets the criteria for the environmental risk assessment to stop at VICH
Phase I (where the potential for environmental exposure is assessed based on the intended use of the
product—in this case for companion animals only). The Department of the Environment have
recommended to the APVMA that the use of the product on dogs and cats under the proposed use pattern
is unlikely to have an unintended effect that is harmful to the environment. The APVMA has considered
these findings and accepts the recommendations of the Department of the Environment. The product labels
will contain a suitable disposal statement.
3.
The APVMA has evaluated the product and in its assessment in relation to whether the trade criteria have been met
in accordance with section 5C(1) of the Agvet Code, it proposes to determine that:
(i)
The APVMA is satisfied that the proposed use of BUPREDYNE INJECTION would not unduly prejudice
trade or commerce between Australia and places outside Australia as BUPREDYNE INJECTION is for use
in dogs and cats, which are not food-producing animals nor do they produce any major Australian export
commodities.
4.
The APVMA has evaluated the product and in its assessment in relation to target animal safety under section
5A(1)(c) of the Agvet Code, it proposes to determine that:
(i)
The APVMA is satisfied that BUPREDYNE INJECTION if used according to BUPREDYNE INJECTION
label directions, is not, or would not be, likely to have an unintended effect that is harmful to animals.
An external reviewer evaluated the data provided and found that the submitted data support the safety of
the proposed product when used as an analgesic injection for dogs and cats. As with all opioid drugs, care
should be taken when using Bupredyne Injection in animals with impaired respiratory function, impaired
liver function or bile tract disease.
Safety in dogs
In addition to published literature provided to support the safety of the proposed product at the proposed
dose rate, the applicant also conducted a safety study using 0, 1, 3 and 5 times the recommended dose
rate. The four period, dose escalation, target animal safety study used the same dogs in each treatment
phase, with a 7 day washout period between treatment phases. The trial design contained no parallel
control dogs.
The effects observed at 1x the recommend dose (0.02 mg/kg) given at 6 hourly intervals on 4 occasions
were consistent with the known pharmacological effects of the applicant active constituent, including; slight
to moderate sedation, decreased rectal temperature, slight ataxia, slow proprioceptive reflexes, slow pinch
reflexes, decreased heart rate, decreased respiration rate, and salivation. Even though this study contained
no parallel control dogs, combined with the other safety data provided, the data support the safety of the
proposed product in healthy dogs from 5 months of age when given at the recommended dose of
0.02 mg/kg.
Buprenorphine in BUPREDYNE INJECTION
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
25
Safety in cats
Multiple published studies from the literature were provided to support the safety of buprenorphine in cats.
The reviewer considered that the publicly available information demonstrated the safety of buprenorphine
to cats. Data were also provided to demonstrate that the product excipients are not expected to result in
adverse effects to either efficacy or safety.
The APVMA agrees with the recommendations of the external reviewer and is satisfied that the product
would not have an unintended effect that is harmful to dogs and cats. Contraindications, precautions and
side effects statements will be included on the label.
5.
The APVMA has evaluated the product and in its assessment in relation to efficacy under section 5B(1) of the Agvet
Code, it proposes to determine that:
(i)
The APVMA is satisfied that BUPREDYNE INJECTION, if used according to BUPREDYNE INJECTION
label directions, BUPREDYNE INJECTION would be effective as an analgesic injection for dogs and cats.
An external reviewer evaluated the data provided and found that the submitted data support the efficacy of
the proposed product as an analgesic injection for dogs and cats. Specifically, the reviewer has supported
the indication for the control of postoperative pain associated with surgical procedures in dogs and cats. It
is intended that the first dose of buprenorphine is given as part of a premedication regimen prior to general
anaesthesia and surgery. Dogs are to be given 0.02 mg/kg bodyweight, repeated if necessary after
5– 6 hours. Cats are to be given 0.02 mg/kg bodyweight, repeated if necessary once as required.
Efficacy in dogs
Multiple published studies from the literature were provided to support the efficacy of buprenorphine in
dogs, as well as two pivotal clinical efficacy trials and pharmacokinetic information. Buprenorphine is rapidly
absorbed after intramuscular injection in various animal species and humans. The substance is highly
lipophilic and the volume of distribution in body compartments is large. The available studies suggest that
buprenorphine has a maximum concentration of 26.1 ng/mL and an area under the curve (AUC) of
633.0 ng/min/mL after intravenous administration of 20 μg/kg buprenorphine in dogs. The mean terminal
half-life was 9 hours and the mean clearance was 24 mL/kg/min, however, there is considerable inter-dog
variability in pharmacokinetic parameters. Oral bioavailability (following gastric tube dosing), was estimated
from AUC following intravenous (IV) and oral administration was 3–6%, owing to buprenorphine being a
highly protein bound drug. Buprenorphine is highly bound to plasma proteins (78–81% in dogs), and in
protein-binding studies in rats is has been shown to bind principally to alpha and beta globulins.
Buprenorphine undergoes N-dealkylation and glucuronide conjugation by the intestinal wall and the liver.
Most of the buprenorphine dose is excreted unchanged via the bile into the gastro-intestinal tract.
Buprenorphine metabolites are also excreted in the urine to a minor extent. The major route of excretion in
all species except the rabbit (where urinary excretion predominates) is the faeces.
The efficacy studies examined administration of buprenorphine at various doses in dogs presented for
surgical castration or ovariohysterectomy. The study results indicate that buprenorphine at 0.02 mg/kg
intramuscularly (IM) preoperative is the optimal dose for producing preoperative sedation and perioperative
analgesia in dogs undergoing soft tissue surgery. The data further support that administration of a second
dose of buprenorphine four to six hours later at 0.02 mg/kg IM is clinically relevant. The data support the
safety of perioperative use of buprenorphine in an anaesthetic regimen including acepromazine,
thiopentone, propofol and isoflurane.
Buprenorphine in BUPREDYNE INJECTION
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
26
Efficacy in cats
An efficacy study, published studies from literature and pharmacokinetic information were provided to
support the efficacy of buprenorphine in cats.
Buprenorphine is rapidly absorbed after intramuscular injection in various animal species and humans. The
substance is highly lipophilic and the volume of distribution in body compartments is large. The available
studies suggest that buprenorphine has an area under the curve of 2713 ng/min/mL and a mean terminal
half-life of approximately 6 hours after intravenous administration of 20 μg/kg buprenorphine in cats. There
was found to be a distinct hysteresis between plasma drug concentration and effect; attributed to slow
receptor binding. The pharmacokinetics of buprenorphine in cats differs from the dog in a shorter
elimination half-life following intravenous (IV) administration (6 hours in cats vs 9 hours in dogs), and a
lower steady state volume of distribution (7.1 L/kg in cats vs 24.0 L/kg in dogs).
The efficacy study examined administration of buprenorphine at a dose rate of 0.01–0.02 mg/kg when
compared to 0.04 mg/kg butorphanol in cats presented for various surgical procedures. The results
indicated that buprenorphine provided better and longer lasting postoperative analgesia than butorphanol
when administered to cats. This study and the other published safety data presented support the efficacy of
buprenorphine when used in anaesthetic regimens that include propofol, alfaxalone/alfadalone,
thiopentone, halothane or isoflurane.
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 active buprenorphine should be approved and whether the application for registration of
the product BUPREDYNE INJECTION should be granted. Submissions should relate only to matters that the APVMA is
required by legislation to take into account in deciding whether to approve the active or grant the registration application
for BUPREDYNE INJECTION. These grounds include: for approval of the active constituent, the safety criteria. For the
registration application for BUPREDYNE INJECTION: the safety, efficacy and trade criteria. 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 active constituent should be
approved and whether BUPREDYNE INJECTION 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)
email or postal address
the date you made the submission.
All personal and confidential commercial information (CCI)2 material contained in submissions will be treated
confidentially.
2
A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
Buprenorphine in BUPREDYNE INJECTION
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
27
Written submissions on the APVMA’s proposal to approve the active constituent and grant the application for registration
that relate to the grounds for active approval and/or product registration should be addressed in writing to:
Enquiries
Registration Management and Evaluation
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4700
Fax:
+61 2 6210 4741
Email: enquiries@apvma.gov.au
Buprenorphine in BUPREDYNE INJECTION
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
28
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 Agricultural and Veterinary Chemicals Code Instrument No. 4
(MRL Standard) 2012. The MRL Standard lists MRLs of substances that 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 APVMA has amended the MRL Standard and the changes will have affect the day after the instrument is registered.
Details of the amendment can be found in the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL
Standard) Amendment Instrument 2015 (No. 7).
The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code Instrument
No. 4 (MRL Standard) 2012.
The MRL Standard is accessible via the ComLaw website www.comlaw.gov.au or the links above.
For further information please contact:
MRL Contact Officer
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4897
Fax:
+61 2 6210 4840
Email: enquiries@apvma.gov.au
Amendments to the APVMA MRL Standard
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
29
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
In the previous notice, the APVMA gazetted that 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, have been made.
Under Section 82 of the Food Standards Australia New Zealand Act 1991 the APVMA is proposing to incorporate those
variations (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2015
(No. 7)) to MRLs into Standard 1.4.2. Maximum Residue Limits of the Australia New Zealand Food Standards Code.
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 and FSANZ are satisfied, based on dietary exposure assessments and current health standards, that the
proposed limits are not harmful to public health.
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.
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
30
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 (AGRICULTURAL AND VETERINARY CHEMICALS CODE INSTRUMENT NO. 4 (MRL
STANDARD) AMENDMENT INSTRUMENT 2015 (NO. 7))
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
Standard 1.4.2 of the Australia New Zealand Food Standards Code is varied by –
1.
omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –
Methomyl
Methomyl
Beetroot
Cassava
Potato
Radish
Swede
Sweet potato
Taro
Turnip, garden
1
T1
1
T1
T1
T1
T1
T1
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
Garlic
T0.5
Leafy vegetables [except brassica leafy
5
vegetables; lettuce, head]
Onion, bulb
0.5
2.
omitting from Schedule 1, under the entries for the following chemicals, the maximum residue limit for the food,
substituting –
Fenpyrazamine
Fenpyrazamine
Dried grapes (currants, raisins and
sultanas)
Table grapes
10
2
Iprodione
Iprodione
Pistachio nut
T0.2
Methomyl
Methomyl
Chard
2
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
31
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
Lettuce, head
7
3.
–
inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals
Glufosinate and Glufosinate ammonium
Sum of glufosinate-ammonium, N-acetyl glufosinate
and 3-[hydroxy(methyl)-phosphinoyl] propionic acid,
expressed as glufosinate (free acid)
Common bean (pods and immature
T*0.05
seeds)
Methomyl
Methomyl
Ginger, Japanese
Onion, Chinese
Root and tuber vegetables
Methoxyfenozide
Methoxyfenozide
Podded pea (young pods) (snow and
sugar snap)
T2
T1
1
T3
Quizalofop-ethyl
Sum of quizalofop-ethyl and quizalofop acid and
other esters, expressed as quizalofop-ethyl
Quinoa
T*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
Bulb vegetables
0.5
Herbs
15
Leafy vegetables [except brassica
5
leafy vegetables; lettuce, head; lettuce,
leaf]
Lettuce, leaf
15
Rhubarb
5
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
32
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.
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: 6 pm (AEST) 8 September 2015
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:
MRL Contact Officer
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4897
Fax:
+61 2 6210 4840
Email: enquiries@apvma.gov.au
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
33
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code
The APVMA has previously gazetted particular amendments which it had made to the APVMA MRL Standard and which
have been proposed as variations to maximum residue limits (MRLs) for substances contained in agricultural and
veterinary chemical products as set out as in Standard 1.4.2–Maximum Residue Limits of the Australia New Zealand
Food Standards Code. This notice pertains to proposals (No. 4) gazetted on 19 May 2015 (No. APVMA 10).
Submissions have been sought on these proposals and the APVMA has written separately to each person or
organisation that made a submission. All matters raised in the submissions have been resolved.
Under subsection 82(1) of the Food Standards Australia New Zealand Act 1991, the APVMA has, by legislative
instrument, incorporated these variations to MRLs into Standard 1.4.2. A copy of the Amendment Instrument (No.
APVMA 6, 2015) accompanies this notice. For a complete and up-to-date version of Standard 1.4.2, including these
amendments together with their Explanatory Statement, please refer to the Federal Register of Legislative Instrument
available on the Comlaw website at www.comlaw.gov.au.
Based on dietary exposure assessments and current health standards, the APVMA and FSANZ are satisfied that these
MRLs are not harmful to public health. 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 by minimising residues in foods consistent with the effective control of pests and
diseases.
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) made Sanitary and Phytosanitary (SPS) notification to the World Trade
Organization (WTO) in relation to these variations and no comment was received in response to that notice.
A copy of these variations have been given to FSANZ.
The variations take effect as from the date of this notice.
This notice is published in accordance with subsection 82(7) of the Food Standards Australia New Zealand Act 1991.
For further information please contact:
Residues Contact Officer
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4897
Fax:
+61 2 6210 4840
Email: enquiries@apvma.gov.au
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
34
Australia New Zealand Food Standards Code—
Standard 1.4.2—Maximum Residue Limits
Amendment Instrument No. APVMA 6, 2015
I, Rajumati Bhula, Executive Director, Scientific Assessment and Chemical Review and delegate of
the Australian Pesticides and Veterinary Medicines Authority, acting in accordance with my powers
under subsection 11(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992,
make this instrument for the purposes of subsection 82(1) of the Food Standards Australia New
Zealand Act 1991.
Rajumati Bhula
Delegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines
Authority
Dated this Sixth day of August 2015
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Part 1
1
Agricultural and Veterinary Chemicals Code Act 1994
35
Preliminary
Name of Instrument
This Instrument is the Australia New Zealand Food Standards Code—Standard 1.4.2—
Maximum Residue Limits Amendment Instrument No. APVMA 6, 2015.
2
Commencement
Pursuant to subsection 82(8) of the Food Standards Australia New Zealand Act 1991,
this Amendment Instrument commences on the day a copy of it is published in the
Gazette.
Note: A copy of the variations made by the Amendment Instrument was published in the Commonwealth of
Australia Agricultural and Veterinary Chemicals Gazette No. APVMA 16 of 11 August 2015.
3
Object
The object of this Instrument is for the APVMA to make variations to Standard 1.4.2—
Maximum Residue Limits of the Australia New Zealand Food Standards Code to
include or change maximum residue limits pertaining to agricultural and veterinary
chemical products.
4
Interpretation
In this Instrument: —
APVMA means the Australian Pesticides and Veterinary Medicines Authority
established by section 6 of the Agricultural and Veterinary Chemicals (Administration)
Act 1992; and
Principal Instrument means Standard 1.4.2 — Maximum Residue Limits of the
Australia New Zealand Food Standard Code as defined in Section 4of the Food
Standards Australia New Zealand Act 1991 being the code published in Gazette
No. P 27 on 27 August 1987 together with any amendments of the standards in that
code. The whole of the Australia New Zealand Food Standard Code (including Standard
1.4.2) was further published in Gazette P 30 of 20 December 2000.
Part 2
5
Variations to Standard 1.4.2—Maximum
Residue Limits
Variations to Standard 1.4.2
The Schedule to this Instrument sets out the variations made to the Principal Instrument
by this Amendment Instrument.
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
36
Schedule
Variations to Standard 1.4.2—Maximum Residue Limits
1
Variations
(1)
The Principal Instrument is varied by:
(a)
omitting from Schedule 1 the chemical residue definition for Fluxapyroxad and substituting the following
chemical residue definitionFluxapyroxad
(b)
inserting in alphabetical order in Schedule 1 –
Bixafen
Commodities of plant origin: Bixafen
Commodities of animal origin: Sum of bixafen and N(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-3(difluoromethyl)-1H-pyrazole-4-carboxamide
(bixafen-desmethyl), expressed as bixafen
Barley
T0.3
Eggs
T*0.02
Edible offal (mammalian)
T1
Meat (mammalian) (in the fat)
T0.3
Milks
T*0.02
Poultry, edible offal of
T*0.02
Poultry meat (in the fat)
T*0.02
Pulses
T0.1
Rape seed
T*0.01
Wheat
T0.5
(c)
–
inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals
Azoxystrobin
Azoxystrobin
Anise myrtle leaves (dried)
Lemon myrtle leaves (dried)
T3
T3
Bifenazate
Sum of bifenazate and bifenazate diazene
(diazenecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl3-yl] 1-methylethyl ester), expressed as bifenazate
Eggs
*0.01
Fruiting vegetables, cucurbits
1
Fruiting vegetables, other than
1
cucurbits [except mushrooms; sweet
corn (corn-on-the-cob)]
Poultry, edible offal of
*0.01
Poultry meat
*0.01
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Cyprodinil
Cyprodinil
Bulb vegetables [except fennel, bulb;
garlic; onion, bulb]
Chives
Difenoconazole
Difenoconazole
Anise myrtle (dried)
Lemon myrtle leaves (dried)
Riberries
Agricultural and Veterinary Chemicals Code Act 1994
T3
T3
T10
T10
T1
Fludioxonil
Commodities of animal origin: Sum of fludioxonil and
oxidisable metabolites, expressed as fludioxonil
Commodities of plant origin: Fludioxonil
Bulb vegetables [except fennel, bulb;
T3
garlic; onion, bulb]
Chives
T3
Dewberries (including loganberry)
T5
[except boysenberry]
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-2ol), expressed as prothioconazole
Commodities of animal origin: Sum of
prothioconazole, prothioconazole desthio (2-(1chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxydesthio (2-(1-chlorocyclopropyl)-1-(2-chloro-3hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol)
and prothioconazole-4-hydroxy-desthio (2-(1chlorocyclopropyl)-1-(2-chloro-4-hydroxyphenyl)-3(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as
prothioconazole
Pulses
T0.1
Tebuconazole
Tebuconazole
Anise myrtle leaves (dried)
Lemon myrtle leaves (dried)
(d)
T5
T5
omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –
Azoxystrobin
Azoxystrobin
Anise myrtle leaves
Lemon myrtle leaves
T100
T100
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code
37
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
38
Bifenazate
Sum of bifenazate and bifenazate diazene
(diazenecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl3-yl] 1-methylethyl ester), expressed as bifenazate
Bitter melon
T0.5
Cucumber
T0.5
Egg plant
T0.1
Melons, except watermelon
T0.3
Peppers
T0.5
Sinkwa or Sinkwa towel gourd
T0.5
Squash, Summer
T0.5
Tomato
T1
Watermelon
T0.3
Fludioxonil
Commodities of animal origin: Sum of fludioxonil and
oxidisable metabolites, expressed as fludioxonil
Commodities of plant origin: Fludioxonil
Dewberries (including boysenberry and
T5
loganberry)
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-2ol), expressed as prothioconazole
Commodities of animal origin: Sum of
prothioconazole, prothioconazole desthio (2-(1chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxydesthio (2-(1-chlorocyclopropyl)-1-(2-chloro-3hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol)
and prothioconazole-4-hydroxy-desthio (2-(1chlorocyclopropyl)-1-(2-chloro-4-hydroxyphenyl)-3(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as
prothioconazole
Chick-pea (dry)
T0.7
Lentil (dry)
T0.7
(e)
omitting from Schedule 1, under the entries for the following chemicals, the maximum residue limit for the food,
substituting –
Azoxystrobin
Azoxystrobin
Riberries
T1
Bifenazate
Sum of bifenazate and bifenazate diazene
(diazenecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl3-yl] 1-methylethyl ester), expressed as bifenazate
Papaya (pawpaw)
2
Strawberry
2
Fluxapyroxad
Commodities of plant origin: Fluxapyroxad
Commodities of animal origin for enforcement:
Fluxapyroxad
Milk fats
0.1
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Indoxacarb
Sum of indoxacarb and its R-isomer
Chia
T0.5
Triadimenol
Triadimenol
see also Triadimefon
Riberries
T0.3
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code
39
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
40
Inclusion of Active Constituent Approvals and Product Registrations in current
Reconsiderations
The APVMA, in accordance with subsection 31(1) of the Agricultural and Veterinary Chemicals Code scheduled to the
Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code), has initiated a reconsideration of the active
constituent approvals and product registrations listed in Attachment 1. These active constituents and products were
approved or registered after the commencement of the original reconsideration.
From 1 July 2015, new legislative requirements became applicable to all reconsiderations. These requirements include
the preparation of a work plan for each reconsideration and that each reconsideration must be completed within the
timeframe prescribed by the regulations.
The APVMA has published the work plans along with the prescribed timeframes on its website for all the
reconsiderations currently in progress.
In order to apply all the legislative requirements uniformly to all the approvals and registrations when the corresponding
chemical is under review, the APVMA will cease the practice of placing a condition at the time of granting the approval or
registration, providing that they would be subject to the outcomes of the corresponding chemical review. Instead, it will
reconsider the new approvals and registrations under subsection 31(1) of the Agvet Code.
Further details about the APVMA chemical review program or details of individual chemical reviews can be obtained from
the APVMA website www.apvma.gov.au or by request to the Chemical Review Liaison Officer on +61 2 6210 4700 or
chemicalreview@apvma.gov.au.
APVMA CONTACT
Liaison Officer
Chemical Review
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4700
Fax:
+61 2 6210 4776
Email:
chemicalreview@apvma.gov.au
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Attachment 1: Active constituent approvals and product registrations placed under reconsideration
2,4-D
Active constituent approvals included in the 2,4-D review
Active number
Active name
Holder
60565
2,4-D-2-ETHYLHEXYL ESTER
RUNGE AGRICHEMS PTY LTD
61329
2,4-D-2-ETHYLHEXYL ESTER
NUFARM AUSTRALIA LIMITED
61699
2,4-D-2-ETHYLHEXYL ESTER
PACIFIC AGRISCIENCE PTY LTD
62068
2,4-D-2-ETHYLHEXYL ESTER
DOW AGROSCIENCES AUSTRALIA LIMITED
64071
2,4-D
IMTRADE AUSTRALIA PTY LTD
64097
2,4-D
CHEMINOVA AUSTRALIA PTY LIMITED
64787
2,4-D
ADAMA AUSTRALIA PTY LIMITED
65372
2,4-D
SHARDA WORLDWIDE EXPORTS PVT LTD
65431
2,4-D-2-ETHYLHEXYL ESTER
ACCENSI PTY LTD
66594
2,4-D TECHNICAL
AGRI ENVIRONMENTAL PTY LTD
67099
2,4-D
68068
2,4-D-2-ETHYLHEXYL ESTER
ADAMA AUSTRALIA PTY LIMITED
68844
2,4-D
AGROGILL CHEMICALS PTY LTD
68950
2,4-D
KINGTAI CHEMICALS CO., LIMITED
69040
2,4-D-2-ETHYLHEXYL ESTER
TOLLMAN PTY LTD
69783
2,4-D
GOLD ZONE ENTERPRISES LTD
JIANGSU GOOD HARVEST-WEIEN
AGROCHEMICAL CO LTD
Registered products (along with their labels) included in the 2,4-D review
Active number
48066
57926
58308
58435
58439
Active name
MULTICROP PYRETHRUM
LONGLIFE INSECT SPRAY
COBBER HERBICIDE
GENEREX 2,4-D AMINE 625
HERBICIDE
OSPRAY 2,4-D 300 HERBICIDE
OSPRAY 2,4-D LOW ODOUR 500
SELECTIVE HERBICIDE
Holder
MULTICROP (AUST.) PTY.LTD
CROP CARE AUSTRALASIA PTY LTD
MACSPRED PTY. LTD
CHEMINOVA AUSTRALIA PTY LIMITED
CHEMINOVA AUSTRALIA PTY LIMITED
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
41
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
58508
58762
58811
58914
58915
58917
58925
58927
58990
59436
59600
59649
59795
59868
Agricultural and Veterinary Chemicals Code Act 1994
Active name
AMINOZ 625 SELECTIVE
WEEDKILLER BY SANONDA
DOW AGROSCIENCES 2,4-D
AMINE 625 HERBICIDE
RYGEL AMINE 625 SELECTIVE
HERBICIDE
INCA 625 HERBICIDE
CHOICE LOW ODOUR AMINE 625
HERBICIDE
INCA 300 HERBICIDE
PACIFIC 2,4-D AMINE 625
HERBICIDE
PACIFIC 2,4-D IPA 300 HERBICIDE
ZEPHYR 625 2,4-D LOW ODOUR
HERBICIDE
CHEMAG SMASH 625 LOW
SELECTIVE HERBICIDE
AMINOZ CT 300 HERBICIDE BY
SANONDA
CONQUEST LV ESTER 600
HERBICIDE
RYGEL 2,4-D IPA 300 HERBICIDE
FARMOZ 2,4-D LV ESTER 600
HERBICIDE
Holder
SANONDA (AUSTRALIA) PTY LTD
DOW AGROSCIENCES AUSTRALIA LIMITED
PROFENG AUSTRALIA PTY LTD
PROTERRA PTY LTD
GROW CHOICE PTY LIMITED
PROTERRA PTY LTD
PACIFIC AGRISCIENCE PTY LTD
PACIFIC AGRISCIENCE PTY LTD
CROP CARE AUSTRALASIA PTY LTD
IMTRADE AUSTRALIA PTY LTD
SANONDA (AUSTRALIA) PTY LTD
CONQUEST CROP PROTECTION PTY LTD
PROFENG AUSTRALIA PTY LTD
ADAMA AUSTRALIA PTY LIMITED
59972
TOWELUP 2,4-D HERBICIDE
GROW CHOICE PTY LIMITED
60216
ESTERON LV HERBICIDE
DOW AGROSCIENCES AUSTRALIA LIMITED
60394
KENDON 2,4-D AMINE 625
KENDON CHEMICALS & MNFG CO PTY LTD
60545
60651
60938
61116
61117
61166
61182
CHEMINOVA 2,4-D AMINE 625
SELECTIVE HERBICIDE
CP-AMINE 500 SELECTIVE
HERBICIDE
NUFARM ESTERCIDE XTRA 680
HERBICIDE
STATESMAN 720 HERBICIDE
DOW AGROSCIENCES AMINE 625
HERBICIDE
CROP CARE LV ESTER 680
HERBICIDE
ABOUND 400 HERBICIDE
CHEMINOVA AUSTRALIA PTY LIMITED
CP MANUFACTURING SDN BHD
NUFARM AUSTRALIA LIMITED
DOW AGROSCIENCES AUSTRALIA LIMITED
DOW AGROSCIENCES AUSTRALIA LIMITED
CROP CARE AUSTRALASIA PTY LTD
DOW AGROSCIENCES AUSTRALIA LIMITED
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
42
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
61222
61327
61328
61380
61482
61515
61565
61893
61895
61896
61931
61935
Agricultural and Veterinary Chemicals Code Act 1994
Active name
OSPRAY 2,4-D LV ESTER 600
HERBICIDE
SMART 2,4-D AMINE 625
HERBICIDE
PYRESTA LV HERBICIDE
RYGEL LOW VOLATILE ESTER 600
HERBICIDE
WSD 2,4-D ESTER 600 HERBICIDE
NUFARM SURPASS 475
HERBICIDE
CROP CARE COBBER 475
HERBICIDE
KENSO AGCARE KEN-STAR 450
HERBICIDE
ADAMA 2,4-D LV ESTER 680
HERBICIDE
4FARMERS 2,4-D AMINE 625
HERBICIDE
CHEMFORCE 2,4-D AMINE 625
HERBICIDE
CHEMFORCE 2,4-D LV 600
HERBICIDE
Holder
CHEMINOVA AUSTRALIA PTY LIMITED
CROP SMART PTY LTD
SIPCAM PACIFIC AUSTRALIA PTY LTD
PROFENG AUSTRALIA PTY LTD
WSD AGRIBUSINESS PTY LTD
NUFARM AUSTRALIA LIMITED
CROP CARE AUSTRALASIA PTY LTD
KENSO CORPORATION (M) SDN. BHD.
ADAMA AUSTRALIA PTY LIMITED
4 FARMERS AUSTRALIA PTY LTD
CHEMFORCE 2010 PTY LTD
CHEMFORCE 2010 PTY LTD
62001
RICOCHET HERBICIDE
CHEMINOVA AUSTRALIA PTY LIMITED
62198
SIPCAM LV ESTER 680 HERBICIDE
SIPCAM PACIFIC AUSTRALIA PTY LTD
62330
62342
62347
62550
62684
62691
62751
62817
62823
62914
4FARMERS 2,4-D AMINE 625
SELECTIVE HERBICIDE
4FARMERS 2,4-D LV ESTER 680
SELECTIVE HERBICIDE
GENFARM LV ESTER 600
HERBICIDE
APPARENT 2,4-D 625 AMINE
HERBICIDE
GENFARM 2,4-D LV ESTER 680
HERBICIDE
NUFARM AMICIDE 720 SELECTIVE
HERBICIDE
NUFARM TROOPER 75-D
HERBICIDE
4FARMERS 2, 4-D AMINE 750
SELECTIVE HERBICIDE
4 FARMERS AUSTRALIA PTY LTD
4 FARMERS AUSTRALIA PTY LTD
LANDMARK OPERATIONS LIMITED
APPARENT PTY. LTD
LANDMARK OPERATIONS LIMITED
NUFARM AUSTRALIA LIMITED
NUFARM AUSTRALIA LIMITED
4 FARMERS AUSTRALIA PTY LTD
SUPERWAY 2,4-D AMINE 625
SUPERWAY GARDEN AG & PEST PRODUCTS
HERBICIDE
PTY LTD
CHEMINOVA 2,4-D ESTER 680
HERBICIDE
CHEMINOVA AUSTRALIA PTY LIMITED
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
43
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Active number
Active name
Holder
62926
WEEDS OUT 300 HERBICIDE
BIOTIS LIFE SCIENCE PTY LTD
63140
AW ANGUISH 625 HERBICIDE
AGRI WEST PTY LIMITED
63141
AW APPLAUSE 300 HERBICIDE
AGRI WEST PTY LIMITED
63271
63272
63282
63327
63386
63412
63495
63538
63668
63775
63813
GENFARM 2,4-D AMINE 625
HERBICIDE
GENFARM 2,4-D AMINE 300
HERBICIDE
IMTRADE SMASH 625 SELECTIVE
HERBICIDE
IMTRADE COMMANDER 75-D
HERBICIDE
NUFARM AMICIDE 500 SELECTIVE
HERBICIDE
TITAN LV ESTER 680 HERBICIDE
ACCENSI AMINE 625 DUAL SALT
SELECTIVE HERBICIDE
IMTRADE SMASH 300 SELECTIVE
HERBICIDE
BIOTIS AMINE 720 SELECTIVE
HERBICIDE
BIOTIS AMINE 625 SELECTIVE
HERBICIDE
PUTRA-AMINE 625 SELECTIVE
HERBICIDE
LANDMARK OPERATIONS LIMITED
LANDMARK OPERATIONS LIMITED
IMTRADE AUSTRALIA PTY LTD
IMTRADE AUSTRALIA PTY LTD
NUFARM AUSTRALIA LIMITED
TITAN AG PTY LTD
ACCENSI PTY LTD
IMTRADE AUSTRALIA PTY LTD
BIOTIS LIFE SCIENCE PTY LTD
BIOTIS LIFE SCIENCE PTY LTD
HEXTAR CHEMICALS PTY LTD
63815
PUTRA-AMINE 300 HERBICIDE
HEXTAR CHEMICALS PTY LTD
63833
AW FRENZY HERBICIDE
AGRI WEST PTY LIMITED
63863
TITAN AMINE 300 AC HERBICIDE
TITAN AG PTY LTD
63999
ACCENSI 2,4-D AMINE 300
SELECTIVE HERBICIDE
64122
TRAPPER HERBICIDE
64206
ENFORCER 75-D HERBICIDE
64350
64351
64387
64419
FARMALINX 2,4-D LV ESTER 680
HERBICIDE
FARMALINX 2,4-D 625 HERBICIDE
IMTRADE LV ESTER 680
HERBICIDE
FARMALINX 2,4-D 300 HERBICIDE
ACCENSI PTY LTD
GLENCORE LAND (AUSTRALIA) P/L T/A
CORPORATE CROPPING
ADAMA AUSTRALIA PTY LIMITED
FARMALINX PTY LTD
FARMALINX PTY LTD
IMTRADE AUSTRALIA PTY LTD
FARMALINX PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
44
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Active number
Active name
Holder
64433
TITAN AMINE 475 HERBICIDE
TITAN AG PTY LTD
64535
AW RANKLE 680 HERBICIDE
AGRI WEST PTY LIMITED
64539
D CLEAN ESTER 680 HERBICIDE
MACROFERTIL AUSTRALIA PTY LTD
64545
NAADCO 2,4-D 300 HERBICIDE
64551
64700
GENFARM GEN-AMINE 625
HERBICIDE
RC AMINE 625 SELECTIVE
HERBICIDE
NEW AUSTRALIA AGRICULTURAL
DEVELOPMENT COMPANY PTY LTD
LANDMARK OPERATIONS LIMITED
RURALCHEM PTY LTD
64728
AGRO-ESSENCE 2,4-D 625SL
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
64758
AC JOKER 625 HERBICIDE
AXICHEM PTY LTD
64793
ACCENSI 2,4-D 475 DUAL
SELECTIVE HERBICIDE
ACCENSI PTY LTD
64806
RC AMINE 300 HERBICIDE
RURALCHEM PTY LTD
64837
RC LV ESTER 680 HERBICIDE
RURALCHEM PTY LTD
64859
AC PULVERIZE HERBICIDE
AXICHEM PTY LTD
64951
64960
65006
65116
65153
65224
65226
65302
65309
65634
65638
65665
CONQUEST LV ESTER 680
HERBICIDE
FARMALINX STUKA 75-D
HERBICIDE
BIOTIS 2,4-D ESTER 680
HERBICIDE
SMART ESTER 680 HERBICIDE
APPARENT 2,4-D ESTER 680
HERBICIDE
KENSO AGCARE KEN-ESTER LV
680 SELECTIVE HERBICIDE
CONQUEST CROP PROTECTION PTY LTD
FARMALINX PTY LTD
BIOTIS LIFE SCIENCE PTY LTD
CROP SMART PTY LTD
APPARENT PTY. LTD
KENSO CORPORATION (M) SDN. BHD
PACIFIC 2,4-D LVE 680 HERBICIDE
PACIFIC AGRISCIENCE PTY LTD
RAINBOW 2,4-D AMINE 625
SHANDONG RAINBOW INTERNATIONAL CO.,
HERBICIDE
LTD
RAINBOW 2,4-D IPA 300
SHANDONG RAINBOW INTERNATIONAL CO.,
HERBICIDE
LTD
CROP CARE 2,4-D AMINE 500
HERBICIDE
KENSO AGCARE KEN-AMINE 720
SELECTIVE HERBICIDE
SMART 2, 4-D 300 HERBICIDE
CROP CARE AUSTRALASIA PTY LTD
KENSO CORPORATION (M) SDN. BHD
CROP SMART PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
45
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Active number
Active name
Holder
65701
GF-2576 HERBICIDE
DOW AGROSCIENCES AUSTRALIA LIMITED
RAINBOW 2,4-D ESTER 680
SHANDONG RAINBOW INTERNATIONAL CO.,
HERBICIDE
LTD
65815
65849
66069
66167
66321
66332
66440
66459
66472
66525
66526
66528
66567
66569
66582
FOSTERRA 2,4-D AMINE 625
SELECTIVE HERBICIDE
SMART PASS 450 HERBICIDE
NUFARM AMICIDE ADVANCE 700
SELECTIVE HERBICIDE
OZCROP 2,4-D AMINE 625
HERBICIDE
OZCROP 2,4-D IPA 300 HERBICIDE
ECHEM 2,4-D 625 AMINE
HERBICIDE
MISSION PICLORAM 75-D
HERBICIDE
CHOICE 2,4-D ESTER 680
HERBICIDE
ACP AMINEX 300 SELECTIVE
HERBICIDE
ACP AMINEX 625 SELECTIVE
HERBICIDE
ACP AMINEX 475 SELECTIVE
HERBICIDE
ACP SILVESTER 680 HERBICIDE
MIRACLE-GRO SLOW RELEASE
LAWN FOOD WEED CONTROL
4FARMERS 2,4-D PLUS PICLORAM
HERBICIDE
66625
TRIO 2,4-D AMINE 625 HERBICIDE
66630
PRO 2,4-D AMINE 625 HERBICIDE
66749
66751
66830
67109
67141
67219
CHEMTURA LANTERN 625
HERBICIDE
CHEMTURA BASILICA 300
HERBICIDE
MISSION 2,4-D ESTER 680 EC
HERBICIDE
KENSO AGCARE BUCKO 75-D
HERBICIDE
AGSPRAY 2,4-D IPA 300
HERBICIDE
EASYFARM 2,4-D IPA 300
HERBICIDE
FOSTERRA PTY LTD
CROP SMART PTY LTD
NUFARM AUSTRALIA LIMITED
OZCROP PTY. LTD
OZCROP PTY. LTD
ECHEM (AUST) PTY LIMITED
MISSION BELL HOLDINGS PTY LTD
GROW CHOICE PTY LIMITED
AUSTRALIS CROP PROTECTION PTY LTD
AUSTRALIS CROP PROTECTION PTY LTD
AUSTRALIS CROP PROTECTION PTY LTD
AUSTRALIS CROP PROTECTION PTY LTD
SCOTTS AUSTRALIA PTY LTD
4 FARMERS AUSTRALIA PTY LTD
AUSTRALIAN PROGRESSIVE SUPPLIES PTY
LTD
AUSTRALIAN PROGRESSIVE SUPPLIES PTY
LTD
CHEMTURA AUSTRALIA PTY LTD
CHEMTURA AUSTRALIA PTY LTD
MISSION BELL HOLDINGS PTY LTD
KENSO CORPORATION (M) SDN. BHD
AGKARE PTY LTD
EASYFARM PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
46
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
67221
67261
67300
67357
Agricultural and Veterinary Chemicals Code Act 1994
Active name
NOVAGUARD 2,4-D AMINE 625
HERBICIDE
AGRO-ESSENCE 2,4-D 300
HERBICIDE
AGSPRAY 2,4-D AMINE 625
SELECTIVE HERBICIDE
MISSION 2,4-D AMINE 625
SELECTIVE HERBICIDE
Holder
NOVAGUARD PTY LTD
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
AGKARE PTY LTD
MISSION BELL HOLDINGS PTY LTD
67360
AGRI 2,4-D AMINE 625 HERBICIDE
AGRI ENVIRONMENTAL PTY LTD
67398
SABAKEM 2,4-D 300 HERBICIDE
SABAKEM PTY LTD
67401
67490
67556
SABAKEM 2,4-D 625 SELECTIVE
HERBICIDE
ACCENSI 2,4-D / PICLORAM
HERBICIDE
FMC 2,4-D IPA 300 SELECTIVE
HERBICIDE
SABAKEM PTY LTD
ACCENSI PTY LTD
FMC AUSTRALASIA PTY LTD
67557
FMC 2,4-D AMINE 625 HERBICIDE
FMC AUSTRALASIA PTY LTD
67579
TITAN PICLORAM 75-D HERBICIDE
TITAN AG PTY LTD
67615
67648
67886
67923
68007
68049
68115
68117
68145
68199
68240
AGRO-ESSENCE 2,4-D ESTER 680
HERBICIDE
AUSAGRI 2,4-D AMINE 625
HERBICIDE
SPALDING AMINE 625 SELECTIVE
HERBICIDE
SPALDING 2,4-D IPA 300
HERBICIDE
FARMALINX 2,4-D LV ESTER 450
HERBICIDE
EZYCROP 2,4-D IPA 300
HERBICIDE
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
AUSAGRI IP PTY LTD
SPALDING HOLDINGS PTY. LTD
SPALDING HOLDINGS PTY. LTD
FARMALINX PTY LTD
EZYCROP PTY LTD
CROPPRO 2,4-D ESTER 680
ZHEJIANG XINAN CHEMICAL INDUSTRIAL
HERBICIDE
GROUP CO., LTD
CROPPRO 2,4-D AMINE 625
ZHEJIANG XINAN CHEMICAL INDUSTRIAL
HERBICIDE
GROUP CO., LTD
RAINBOW 2,4-D AMINE 800 SG
SHANDONG RAINBOW INTERNATIONAL CO.,
HERBICIDE
LTD
NOVAGUARD 2,4-D IPA 300
HERBICIDE
FMC 2,4-D LV ESTER 680
HERBICIDE
68241
FMC 2,4-D IPA 400 HERBICIDE
68270
RAINBOW 2,4-D 450 SL HERBICIDE
NOVAGUARD PTY LTD
FMC AUSTRALASIA PTY LTD
FMC AUSTRALASIA PTY LTD
SHANDONG RAINBOW INTERNATIONAL CO.,
LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
47
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Active number
Active name
Holder
68352
FMC LV ESTER 680 HERBICIDE
FMC AUSTRALASIA PTY LTD
68363
UMINE 625 SELECTIVE HERBICIDE
UPL AUSTRALIA LIMITED
68429
OZCROP 2,4-D ESTER 680
HERBICIDE
OZCROP PTY. LTD
68475
AGMATE 2,4-D 300 SL HERBICIDE
AGCARE PTY LTD
68480
AGMATE 2,4-D 625 SL HERBICIDE
AGCARE PTY LTD
68535
68558
ACCENSI 2,4-D LOW ODOUR 500
SELECTIVE HERBICIDE
EZYCROP 2,4-D AMINE 625
HERBICIDE
ACCENSI PTY LTD
EZYCROP PTY LTD
68586
ACP BROADLEAF 75-D HERBICIDE
AUSTRALIS CROP PROTECTION PTY LTD
68933
ZULU EVO 720 HERBICIDE
ADAMA AUSTRALIA PTY LIMITED
68986
68995
CONQUEST DEPIC 75-D
HERBICIDE
CONQUEST AMINE PLUS 475
SELECTIVE HERBICIDE
CONQUEST CROP PROTECTION PTY LTD
CONQUEST CROP PROTECTION PTY LTD
69019
JNO 2,4-D AMINE 625 HERBICIDE
JNO INVESTMENT HOLDINGS PTY LTD
69020
JNO 2,4-D ESTER 680 HERBICIDE
JNO INVESTMENT HOLDINGS PTY LTD
69060
69074
69095
69106
APPARENT 2,4-D 450 IPA
HERBICIDE
OZCROP 2,4-D IPA 450 SL
HERBICIDE
FARMALINX 2,4-D 450 SL
HERBICIDE
FALLOWBOSS TORDON
HERBICIDE
APPARENT PTY. LTD
OZCROP PTY. LTD
FARMALINX PTY LTD
DOW AGROSCIENCES AUSTRALIA LIMITED
69205
APPARENT EXCEED HERBICIDE
APPARENT PTY. LTD
69213
FORWARD AMINE 625 HERBICIDE
FORWARD AUSTRALIA PTY LTD
69214
69247
69446
69663
69770
FORWARD 2,4-D ESTER 680
HERBICIDE
SABAKEM 2,4-D LVE 680
HERBICIDE
AC ESCORT 680 HERBICIDE
AGROCN 2,4-D 625 SL SELECTIVE
HERBICIDE
FORWARD AUSTRALIA PTY LTD
SABAKEM PTY LTD
AXICHEM PTY LTD
SHANGHAI AGROCHINA CHEMICAL CO LTD
RAINBOW PICLORAM 75-D
SHANDONG RAINBOW INTERNATIONAL CO.,
HERBICIDE
LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
48
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
69835
69915
Agricultural and Veterinary Chemicals Code Act 1994
Active name
Holder
MACRO PROTECT 2,4-D AMINE 625
LOUIS DREYFUS COMMODITIES AUSTRALIA
AC HERBICIDE
PTY. LTD
FORWARD 2,4-D IPA 300
HERBICIDE
FORWARD AUSTRALIA PTY LTD
69921
OZTEC 2,4-D IPA 300 HERBICIDE
OZTEC RURAL PTY LTD
69952
PYRESTA XTREME LV HERBICIDE
SIPCAM PACIFIC AUSTRALIA PTY LTD
70018
KELPIE AMINE 625 HERBICIDE
70110
KELPIE AMINE 300 HERBICIDE
70153
70166
70174
OZCROP PICLORAM 75-D
HERBICIDE
WELLFARM 2,4-D AMINE 625 SL
HERBICIDE
PILAR-2,4-D 625 SL HERBICIDE
SINOCHEM INTERNATIONAL AUSTRALIA PTY
LTD
SINOCHEM INTERNATIONAL AUSTRALIA PTY
LTD
OZCROP PTY. LTD
WELLFARM PTY LTD
PILARQUIM (SHANGHAI) CO LTD
Chlorpyrifos
Active constituent approvals included in the chlorpyrifos review
Active number
Active name
Holder
44111
CHLORPYRIFOS
DOW AGROSCIENCES AUSTRALIA LIMITED
44112
CHLORPYRIFOS
DOW AGROSCIENCES AUSTRALIA LIMITED
44113
CHLORPYRIFOS
DOW AGROSCIENCES AUSTRALIA LIMITED
44160
CHLORPYRIFOS
DOW AGROSCIENCES AUSTRALIA LIMITED
47155
CHLORPYRIFOS
EXCEL CROP CARE (AUSTRALIA) PTY LTD
49124
49340
CHLORPYRIFOS
MANUFACTURING CONCENTRATE
CHLORPYRIFOS
MANUFACTURING CONCENTRATE
DOW AGROSCIENCES AUSTRALIA LIMITED
DOW AGROSCIENCES AUSTRALIA LIMITED
50886
CHLORPYRIFOS
IMTRADE AUSTRALIA PTY LTD
55457
CHLORPYRIFOS
AGROGILL CHEMICALS PTY LTD
56174
CHLORPYRIFOS
DOW AGROSCIENCES AUSTRALIA LIMITED
58019
CHLORPYRIFOS
SABERO AUSTRALIA PTY LIMITED
60079
CHLORPYRIFOS
AGROGILL CHEMICALS PTY LTD
62025
CHLORPYRIFOS
AGKARE PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
49
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Active number
Active name
Holder
64006
CHLORPYRIFOS
NETMATRIX LIMITED
65331
CHLORPYRIFOS
LANDMARK OPERATIONS LIMITED
65346
CHLORPYRIFOS
IMTRADE AUSTRALIA PTY LTD
65403
CHLORPYRIFOS
SINON AUSTRALIA PTY LIMITED
67013
CHLORPYRIFOS
SHARDA WORLDWIDE EXPORTS PVT LTD
67331
CHLORPYRIFOS
AGROSHINE AUSTRALIA PTY LTD
70330
CHLORPYRIFOS
ZHEJIANG HENGDIAN IMP. & EXP. CO LTD
70430
CHLORPYRIFOS
SABAKEM PTY LTD
Registered products (along with their labels) included in the chlorpyrifos review
Active number
Active name
Holder
32887
LORSBAN 500 EC INSECTICIDE
DOW AGROSCIENCES AUSTRALIA LIMITED
47760
MASTER 250 CS INSECTICIDE
ADAMA AUSTRALIA PTY LIMITED
48770
48998
49315
49666
50232
50387
50416
50452
50639
FARMOZ STRIKE-OUT PC
TERMITICIDE AND INSECTICIDE
ADAMA AUSTRALIA PTY LIMITED
CYREN 500 EC INSECTICIDE
CHEMINOVA AUSTRALIA PTY LIMITED
RICHGRO GARDEN PRODUCTS
A. RICHARDS PTY LTD T/A RICHGRO GARDEN
LAWN BEETLE AND GRUB KILLER
PRODUCTS
BARMAC CHLORPYRIFOS G
GRANULAR INSECTICIDE
FARMOZ INSTINCT 300 COTTON
INSECTICIDE
TITAN CHLORPYRIFOS 500
TERMITICIDE AND INSECTICIDE
SUSCON GREEN SOIL
INSECTICIDE
TITAN CHLORPYRIFOS PC 450
INSECTICIDE
BARMAC KILLMASTER
INSECTICIDE
AMGROW PTY LTD
ADAMA AUSTRALIA PTY LIMITED
TITAN AG PTY LTD
CROP CARE AUSTRALASIA PTY LTD
TITAN AG PTY LTD
AMGROW PTY LTD
CREOFOS PRE-CONSTRUCTION 50956
POST-CONSTRUCTION
CREEPY CRAWLY PEST CONTROL PTY LTD
TERMITICIDE & INSECTICIDE
51107
SUSCON ULTRA SOIL
INSECTICIDE
CROP CARE AUSTRALASIA PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
50
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
Agricultural and Veterinary Chemicals Code Act 1994
Active name
Holder
COUNTRY PRE51151
CONSTRUCTION/POSTCONSTRUCTION TERMITICIDE
GARRARDS PTY LTD
AND INSECTICIDE
51190
IMTRADE CHLORPYRIFOS 500
INSECTICIDE
IMTRADE AUSTRALIA PTY LTD
51211
LORSBAN 750 WG INSECTICIDE
DOW AGROSCIENCES AUSTRALIA LIMITED
51513
CYREN 500 WP INSECTICIDE
CHEMINOVA AUSTRALIA PTY LIMITED
51524
Y-TEX WARRIOR INSECTICIDAL
CATTLE EAR TAGS
LANDMARK OPERATIONS LIMITED
51592
PREFOS TERMITICIDE
IMTRADE AUSTRALIA PTY LTD
51624
PROWLER 300 INSECTICIDE
IMTRADE AUSTRALIA PTY LTD
51769
GARRARDS ANT KILLER 50
GARRARDS PTY LTD
PIDGEON'S PEST CONTROLLER
51875
500 TERMITICIDE AND
INSECTICIDE
52045
CYREN 300 ULV/EC INSECTICIDE
SUPERWAY GARDEN AG & PEST PRODUCTS
PTY LTD
CHEMINOVA AUSTRALIA PTY LIMITED
MUNNS LAWN GRUBS, LAWN
52167
BEETLE GRUBS & SLATER KILLER
WITH LONG LIFE ORGANICALLY
MUNNS LAWN COMPANY PTY LTD
ADVANCED WETA-LAWN
52235
FARMOZ CYREN 500 WP
INSECTICIDE
ADAMA AUSTRALIA PTY LIMITED
DAVID GRAYS ANTEX 50
52564
GRANULAR PROFESSIONAL
DAVID GRAY & CO. PTY LIMITED
INSECTICIDE
RAVENSDOWN CHLORPYRIFOS
52596
500 INSECTICIDE AND
MACROFERTIL AUSTRALIA PTY LTD
TERMITICIDE
53013
OPTEM DUO TERMITICIDE AND
INSECTICIDE
PCT HOLDINGS PTY LTD
COUNTRY MICRO-LO PRE53192
CONSTRUCTION/POSTCONSTRUCTION TERMITICIDE
GARRARDS PTY LTD
AND INSECTICIDE
53428
GENERIFOS 500EC INSECTICIDE
GROW CHOICE PTY LIMITED
53771
SUSCON PLUS SOIL INSECTICIDE
CROP CARE AUSTRALASIA PTY LTD
54546
PYRITILENE BANANA BAGS
ADAMA AUSTRALIA PTY LIMITED
54957
WSD CHLORPYRIFOS 500 EC
INSECTICIDE
WSD AGRIBUSINESS PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
51
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Active number
Active name
Holder
54963
SUSCON RIBBON INSECTICIDE
CROP CARE AUSTRALASIA PTY LTD
HALLEY CHLORPYRIFOS 500
HALLEY INTERNATIONAL ENTERPRISE
INSECTICIDE
(AUSTRALIA) PTY LTD
55208
55213
55755
55897
55961
55961
56209
56495
56616
56817
57758
58188
KENSO AGCARE KENSBAN 500
INSECTICIDE
FORTUNE 500 MULTI-PURPOSE
INSECTICIDE AND TERMITICIDE
CONQUEST CHLORPYRIFOS 500
INSECTICIDE
SEARLES LAWN GRUB KILLER
GRANULES
SUPERWAY GARDEN AG & PEST PRODUCTS
CONTROLLER
PTY LTD
RICHGRO HOME GARDEN ANT
A. RICHARDS PTY LTD T/A RICHGRO GARDEN
KILLER
PRODUCTS
AMGROW PATROL LAWN GRUB &
BEETLE KILLER GRANULES
SEARLES KILL ANT 50 GRANULES
DAVID GRAYS LAWN BEETLE &
GRUB KILLER INSECTICIDE
SUREFIRE LAWN GRUB,ANT AND
OUTDOOR PEST INSECTICIDE
RICHGRO SLATER KILLER
58294
RICHGRO LAWN BEETLE KILLER
61071
61257
61354
61533
62672
J C & A T SEARLE PTY LTD
SUPERWAY GRUB, ANT AND PEST
58287
60611
CONQUEST CROP PROTECTION PTY LTD
J C & A T SEARLE PTY LTD
RICHGRO ANT KILLER
60188
PCT HOLDINGS PTY LTD
SEARLES ANT KILL 50 GRANULES
58286
58479
KENSO CORPORATION (M) SDN. BHD
GRASS GARD LAWN BEETLE &
GRUB SPRAY
GENFARM CHLORPYRIFOS 500
INSECTICIDE
AGSPRAY CHLORPYRIFOS 500EC
INSECTICIDE
STRIKE-OUT 500 WP INSECTICIDE
GARDEN KING GRUBKIL LAWN
GRUB & BEETLE KILLER
SEARLES LAWN GRUB KILLER
HOSE ON
AMGROW SIR WALTER BUFFALO
LAWN PEST CONTROL
SABERO CHLORPYRIFOS 500EC
INSECTICIDE
AMGROW PTY LTD
J C & A T SEARLE PTY LTD
DAVID GRAY & CO. PTY LIMITED
PCT HOLDINGS PTY LTD
A. RICHARDS PTY LTD T/A RICHGRO GARDEN
PRODUCTS
A. RICHARDS PTY LTD T/A RICHGRO GARDEN
PRODUCTS
A. RICHARDS PTY LTD T/A RICHGRO GARDEN
PRODUCTS
HEINIGER HOME & GARDEN CARE PTY LTD
LANDMARK OPERATIONS LIMITED
AGKARE PTY LTD
ADAMA AUSTRALIA PTY LIMITED
AMGROW PTY LTD
J C & A T SEARLE PTY LTD
AMGROW PTY LTD
SABERO AUSTRALIA PTY LIMITED
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
52
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Active number
Active name
Holder
63086
CHEMICIDE 500 INSECTICIDE
HEXTAR CHEMICALS PTY LTD
63145
63548
64319
64936
65160
65556
66354
66467
66886
67170
AW CUFT 500 INSECTICIDE AND
TERMITICIDE
CHEMFORCE CHLORPYRIFOS 500
INSECTICIDE
FARMALINX CHLORPOS 500 EC
INSECTICIDE
AMGROW PATROL FIX ANT
APPARENT DINGO 500
INSECTICIDE
AGRI WEST PTY LIMITED
CHEMFORCE 2010 PTY LTD
FARMALINX PTY LTD
AMGROW PTY LTD
APPARENT PTY. LTD
RAINBOW CHLORPYRIFOS 500
SHANDONG RAINBOW INTERNATIONAL CO.,
INSECTICIDE
LTD
OZCROP CHLORPYRIFOS 500 EC
INSECTICIDE
MISSION CHLORPYRIFOS 500 EC
INSECTICIDE
CUTTER CHLORPYRIFOS 500 EC
INSECTICIDE
NOVAGUARD CHLORPYRIFOS 500
INSECTICIDE
OZCROP PTY. LTD
MISSION BELL HOLDINGS PTY LTD
IVORYCHEM AUSTRALIA PTY LTD
NOVAGUARD PTY LTD
67248
SEARLES ANT KILL 50
J C & A T SEARLE PTY LTD
67249
SEARLES LAWN GRUB KILLER
J C & A T SEARLE PTY LTD
67451
67832
67833
67834
67887
67984
68279
68467
68561
SABAKEM CHLORPYRIFOS 500EC
INSECTICIDE
FORTUNE 500 (PUBLIC HEALTH)
INSECTICIDE
FORTUNE 500 EC (AGRICULTURE)
INSECTICIDE
FORTUNE 500 TERMI-EC
(TERMITE) TERMITICIDE
SPALDING CHLORPYRIFOS 500
INSECTICIDE
EZYCROP CHLORPYRIFOS 500
INSECTICIDE
AGRO-ESSENCE CHLORPYRIFOS
500 INSECTICIDE
CHLORBAN 500 EC INSECTICIDE
FMC CHLORPYRIFOS 500
INSECTICIDE
SABAKEM PTY LTD
PCT HOLDINGS PTY LTD
PCT HOLDINGS PTY LTD
PCT HOLDINGS PTY LTD
SPALDING HOLDINGS PTY. LTD
EZYCROP PTY LTD
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
UPL AUSTRALIA LIMITED
FMC AUSTRALASIA PTY LTD
ACCENSI MICRO-LO PRE68574
CONSTRUCTION/POSTCONSTRUCTION TERMITICIDE
ACCENSI PTY LTD
AND INSECTICIDE
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
53
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
Agricultural and Veterinary Chemicals Code Act 1994
Active name
Holder
ACCENSI PRE68575
CONSTRUCTION/POSTCONSTRUCTION TERMITICIDE
ACCENSI PTY LTD
AND INSECTICIDE
68678
68729
68745
68781
69048
69671
69776
69990
70062
70266
COBALT ADVANCED INSECTICIDE
CONTRAFORCE TERMITICIDE &
INSECTICIDE
AC CHOP 500 INSECTICIDE AND
TERMITICIDE
PYRINEX SUPER INSECTICIDE /
MITICIDE
SMART CHLORPYRIFOS 500
INSECTICIDE
AGROCN CHLORPYRIFOS 500 EC
INSECTICIDE AND TERMITICIDE
ACCENSI CHLORPYRIFOS 500
INSECTICIDE
AGVANTAGE CHLORPYRIFOS 500
EC INSECTICIDE
MACPHERSONS CHLORPYRIFOS
500 INSECTICIDE
WELLFARM CHLORPYRIFOS 500
EC INSECTICIDE
DOW AGROSCIENCES AUSTRALIA LIMITED
CONTRAFORCE TERMITICIDE & INSECTICIDE
AXICHEM PTY LTD
ADAMA AUSTRALIA PTY LIMITED
CROP SMART PTY LTD
SHANGHAI AGROCHINA CHEMICAL CO LTD
ACCENSI PTY LTD
LANDMARK OPERATIONS LIMITED
TGAC AUSTRALIA PTY. LTD
WELLFARM PTY LTD
Diazinon
Active constituent approvals included in the diazinon review
Active number
Active name
Holder
44033
DIAZINON
ADAMA AUSTRALIA PTY LIMITED
44289
DIAZINON
ZAGRO SINGAPORE PTE LTD
44290
DIAZINON
ZAGRO SINGAPORE PTE LTD
44291
DIAZINON MANUFACTURING
CONCENTRATE
ZAGRO SINGAPORE PTE LTD
44430
DIAZINON
VIRBAC (AUSTRALIA) PTY LTD
44561
DIAZINON
ZAGRO SINGAPORE PTE LTD
46132
DIAZINON
NIPPON KAYAKU CO LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
54
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Registered products (along with their labels) included in the diazinon review
Active number
Active name
Holder
WSD MULESING POWDER WOUND
DRESSING FOLLOWING MULES
39574
OPERATION GENERAL WOUND
WSD AGRIBUSINESS PTY LTD
DRESSING FOR SHEEP, CATTLE
AND GOATS
48917
49876
50007
CRAWLY CRUNCHER HOUSEHOLD
INSECTICIDE SURFACE SPRAY
NUCIDOL 200 EC INSECTICIDE
AND ACARICIDE
BARMAC DIAZINON INSECTICIDE
MATCHLAND PTY LTD
ZAGRO ANIMAL HEALTH PTE LTD
AMGROW PTY LTD
VIRBAC 5 MONTH FLEA & TICK
50145
COLLAR FOR DOGS WATER
VIRBAC (AUSTRALIA) PTY LTD
RESISTANT
EXELPET FLEABAN WATER
50846
RESISTANT 5 MONTH FLEA
COLLAR FOR CATS
EXELPET FLEABAN WATER
50849
RESISTANT 5 MONTH FLEA
COLLAR FOR DOGS
EXELPET PRODUCTS A DIV OF MARS
AUSTRALIA PTY LTD
EXELPET PRODUCTS A DIV OF MARS
AUSTRALIA PTY LTD
DUOGARD BAND FOR DOGS 5
50998
MONTH INTEGRATED FLEA AND
VIRBAC (AUSTRALIA) PTY LTD
TICK CONTROL
DUOGARD BAND FOR CATS 5
50999
MONTH INTEGRATED FLEA
VIRBAC (AUSTRALIA) PTY LTD
CONTROL
VIRBAC PROTECT-A-CAT DOUBLE
51000
ACTION 5 MONTH FLEA BAND FOR
VIRBAC (AUSTRALIA) PTY LTD
CATS
VIRBAC PROTECT-A-DOG DOUBLE
51001
ACTION 5 MONTH FLEA AND TICK
VIRBAC (AUSTRALIA) PTY LTD
BAND FOR DOGS
EUREKA GOLD OP SPRAY-ON
51290
OFF-SHEARS SHEEP LICE
ZAGRO ANIMAL HEALTH PTE LTD
TREATMENT
51524
Y-TEX WARRIOR INSECTICIDAL
CATTLE EAR TAGS
LANDMARK OPERATIONS LIMITED
VITAPET 5 MONTH FLEA COLLAR
53661
FOR CATS WATER RESISTANT,
VIRBAC (AUSTRALIA) PTY LTD
WITH ELASTIC SAFETY STRAP
53669
53910
55722
VITAPET 5 MONTH FLEA COLLAR
FOR DOGS WATER RESISTANT
PATRIOT INSECTICIDE EAR TAG
FOR CATTLE
TERMINATOR INSECTICIDE EAR
TAG FOR CATTLE
VIRBAC (AUSTRALIA) PTY LTD
BAYER AUSTRALIA LTD (ANIMAL HEALTH)
BAYER AUSTRALIA LTD (ANIMAL HEALTH)
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
55
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
58014
Agricultural and Veterinary Chemicals Code Act 1994
Active name
VITAPET 5 MONTH FLEA COLLAR
FOR CATS
Holder
VITAPET CORPORATION PTY LTD
VITAPET 5 MONTH/WATER
58017
RESISTANT FLEA COLLAR FOR
VITAPET CORPORATION PTY LTD
DOGS
58505
59707
60662
61782
61783
DAVID GRAYS DIAZINON 800
INSECTICIDE
FARMOZ DIAZOL 800 INSECTICIDE
CO-RAL PLUS INSECTICIDE
CATTLE EAR TAG
DAVID GRAY & CO. PTY LIMITED
ADAMA AUSTRALIA PTY LIMITED
BAYER AUSTRALIA LTD (ANIMAL HEALTH)
PURINA TOTALCARE FLEA
NESTLE PURINA PETCARE A DIV OF NESTLE
COLLAR FOR DOGS
AUSTRALIA LTD
PURINA TOTALCARE FLEA
NESTLE PURINA PETCARE A DIV OF NESTLE
COLLAR FOR CATS
AUSTRALIA LTD
COOPERS DIAZINON SHEEP
62353
BLOWFLY DRESSING AND
INTERVET AUSTRALIA PTY LIMITED
CATTLE, GOAT AND PIG SPRAY
65776
65779
BOB MARTIN SINCE 1892 FLEA RID
FOR CATS COLLAR
BOB MARTIN SINCE 1892 FLEA RID
FOR DOGS COLLAR
BOB MARTIN (AUSTRALIA) PTY LTD
BOB MARTIN (AUSTRALIA) PTY LTD
NUCIDOL GOLD OP SPRAY-ON
68253
OFF-SHEARS SHEEP LICE
ZAGRO ANIMAL HEALTH PTE LTD
TREATMENT
68534
ACCENSI DIAZINON 800
INSECTICIDE
ACCENSI PTY LTD
Dimethoate
Active constituent approvals included in the dimethoate review
Active number
Active name
Holder
65605
DIMETHOATE
SINON AUSTRALIA PTY LIMITED
66093
DIMETHOATE
FARMALINX PTY LTD
66494
DIMETHOATE
FARMALINX PTY LTD
67003
DIMETHOATE
AGROGILL CHEMICALS PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
56
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Registered products (along with their labels) included in the dimethoate review
Active number
Active name
Holder
58374
CROPRO STALK INSECTICIDE
PCT HOLDINGS PTY LTD
58375
59001
59469
61916
62511
63470
64309
SUREFIRE ORCHARD & GARDEN
INSECTICIDE
AMGROW INSECT & MITE
SYSTEMIC INSECTICIDE
AW DIMETHOATE 400 SYSTEMIC
INSECTICIDE
PCT HOLDINGS PTY LTD
AMGROW PTY LTD
AGRI WEST PTY LIMITED
RICHGRO FRUIT FLY & GARDEN
A. RICHARDS PTY LTD T/A RICHGRO GARDEN
INSECTICIDE
PRODUCTS
TITAN DIMETHOATE 400
SYSTEMIC INSECTICIDE.
COUNTRY DIMETHOATE 400
SYSTEMIC INSECTICIDE
FARMALINX DIMETHOLINX
INSECTICIDE
TITAN AG PTY LTD
ACCENSI PTY LTD
FARMALINX PTY LTD
65259
ROVER SYSTEMIC INSECTICIDE
SIPCAM PACIFIC AUSTRALIA PTY LTD
65260
ROGOR UPGRADE INSECTICIDE
CHEMINOVA AUSTRALIA PTY LIMITED
69555
70165
80540
IMTRADE DIMETHOATE 400 EC
INSECTICIDE
APPARENT DIMETHOATE 400
INSECTICIDE
GENFARM DIMETHOATE 400
INSECTICIDE
IMTRADE AUSTRALIA PTY LTD
APPARENT PTY. LTD
LANDMARK OPERATIONS LIMITED
Diquat
Active constituent approvals included in the diquat review
Active number
44219
56655
56808
58221
58386
59111
Active name
DIQUAT DIBROMIDE
MANUFACTURING CONCENTRATE
Holder
SYNGENTA AUSTRALIA PTY LTD
DIQUAT DIBROMIDE
HALLEY INTERNATIONAL ENTERPRISE
MANUFACTURING CONCENTRATE
(AUSTRALIA) PTY LTD
DIQUAT DIBROMIDE
MANUFACTURING CONCENTRATE
DIQUAT DIBROMIDE
MANUFACTURING CONCENTRATE
DIQUAT DIBROMIDE
MANUFACTURING CONCENTRATE
DIQUAT DIBROMIDE
MANUFACTURING CONCENTRATE
CONQUEST CROP PROTECTION PTY LTD
SINON AUSTRALIA PTY LIMITED
ADAMA AUSTRALIA PTY LIMITED
PACIFIC AGRISCIENCE PTY LTD
62650
DIQUAT DIBROMIDE
AGROGILL CHEMICALS PTY LTD
64501
DIQUAT DIBROMIDE
SHARDA WORLDWIDE EXPORTS PVT LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
57
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Active number
Active name
Holder
67123
DIQUAT DIBROMIDE
AGPRO IP CO. PTY LTD
Registered products included in the diquat review
Active number
Active name
Holder
ROOT OUT SEWER
54668
RECONDITIONING AND
LINCOLN SPECIALTY CHEMICALS PTY LTD
PROTECTION SYSTEM
58411
58833
59332
63173
64177
64311
64829
64889
65909
66064
66120
66685
68432
IMTRADE DIQUAT 200 NONRESIDUAL HERBICIDE
CONQUEST SANCTION 200 NONRESIDUAL HERBICIDE
KENSO AGCARE DIQUAT 200
HERBICIDE
ACCENSI DIQUAT 200 NONRESIDUAL HERBICIDE
TITAN DIQUAT 200 NON-RESIDUAL
HERBICIDE
FARMALINX DIQUAT 200
HERBICIDE
IMTRADE AUSTRALIA PTY LTD
CONQUEST CROP PROTECTION PTY LTD
KENSO CORPORATION (M) SDN. BHD
ACCENSI PTY LTD
TITAN AG PTY LTD
FARMALINX PTY LTD
HYDROGEL D NON-RESIDUAL
BETTER SAFE PEST & WEED MANAGEMENT
HERBICIDE
PTY. LTD
GENFARM DIQUAT 200 NONRESIDUAL HERBICIDE
LANDMARK OPERATIONS LIMITED
RAINBOW DIQUAT 200 NON-
SHANDONG RAINBOW INTERNATIONAL CO.,
RESIDUAL HERBICIDE
LTD
KDPC DESIQUAT NON-RESIDUAL
HERBICIDE
CHEMINOVA DIQUAT 200
HERBICIDE
MACPHERSONS DESI-TEX 200
HERBICIDE
OZCROP DIQUAT 200 HERBICIDE
KD PLANT CARE PTY LTD
CHEMINOVA AUSTRALIA PTY LIMITED
RONIC INTERNATIONAL PTY LIMITED
OZCROP PTY. LTD
Fenitrothion
Active constituent approvals included in the fenitrothion review
Active number
Active name
44499
FENITROTHION
65380
FENITROTHION
Holder
SUMITOMO CHEMICAL AUSTRALIA PTY
LIMITED
IMTRADE AUSTRALIA PTY LTD
Registered products (along with their labels) included in the fenitrothion review
Active number
50774
50775
Active name
Holder
SUMITOMO SUMITHION ULV
SUMITOMO CHEMICAL AUSTRALIA PTY
PREMIUM GRADE INSECTICIDE
LIMITED
SUMITHION 1000EC INSECTICIDE
SUMITOMO CHEMICAL AUSTRALIA PTY
LIMITED
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
58
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
56170
63674
66520
67186
67567
Agricultural and Veterinary Chemicals Code Act 1994
Active name
KENDON FENITROTHION 1000EC
INSECTICIDE
SUREFIRE FENITROTHION 1000EC
INSECTICIDE
GRAIN-GUARD DUO INSECTICIDE
FREEZONE FENITROTHION
INSECTICIDE
FREEZONE SMART GRAIN DUAL
INSECTICIDE
Holder
KENDON PLANT CARE PTY LTD
PCT HOLDINGS PTY LTD
SUMITOMO CHEMICAL AUSTRALIA PTY
LIMITED
FREEZONE PUBLIC HEALTH PTY LTD
FREEZONE PUBLIC HEALTH PTY LTD
Fipronil
Active constituent approvals included in the fipronil review
Active number
Active name
Holder
46789
FIPRONIL
BASF AUSTRALIA LTD.
58418
FIPRONIL
GHARDA AUSTRALIA PTY LTD
59286
FIPRONIL
BASF AUSTRALIA LTD
63161
FIPRONIL
64070
FIPRONIL
ADAMA AUSTRALIA PTY LIMITED
64725
FIPRONIL
IMTRADE AUSTRALIA PTY LTD
65337
FIPRONIL
AGROGILL CHEMICALS PTY LTD
65338
FIPRONIL
CHEMINOVA AUSTRALIA PTY LIMITED
65350
FIPRONIL
KENSO CORPORATION (M) SDN. BHD.
65729
FIPRONIL
ADAMA AUSTRALIA PTY LIMITED
65799
FIPRONIL
BIO QUEST INTERNATIONAL PRIVATE LTD
66043
FIPRONIL
VIRBAC (AUSTRALIA) PTY LTD
66849
FIPRONIL
SINOCHEM NINGBO CHEMICALS CO LTD
67064
FIPRONIL
YONGNONG BIOSCIENCES CO., LTD
67155
FIPRONIL
NUFARM AUSTRALIA LIMITED
68382
FIPRONIL
ENVIROMAX TECHNOLOGIES PTY LTD
68973
FIPRONIL
70260
FIPRONIL
SHANGHAI SAFE-CHEM INTERNATIONAL
TRADE CO LIMITED
SHANDONG RAINBOW INTERNATIONAL CO.,
LTD
JIANGSU FLAG CHEMICAL INDUSTRY CO.,
LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
59
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Registered products (along with their labels) included in the fipronil review
Active number
68315
58478
58661
60654
60664
Active name
TITAN FIPRONIL 200SC
INSECTICIDE
AMULET CUE LURE FRUIT FLY
STATIONS
Holder
TITAN AG PTY LTD
BASF AUSTRALIA LTD
MORTEIN RAT KILL WITH FLEA
RECKITT BENCKISER (AUSTRALIA) PTY
ELIMINATOR
LIMITED
TERMIDOR DRY TERMITICIDE &
INSECTICIDE
CROP CARE AMULET CUE-LURE
FRUIT FLY STATIONS
BASF AUSTRALIA LTD
CROP CARE AUSTRALASIA PTY LTD
60887
ILIUM FRONTERA SPRAY
TROY LABORATORIES PTY LTD
63004
WOLSIT T-35
BASF WOLMAN GMBH
MORTEIN RAT KILL THROWPACKS
RECKITT BENCKISER (AUSTRALIA) PTY
HOUSEHOLD PROTECTION
LIMITED
63885
64194
64195
64196
64197
64226
64373
64449
64884
EFFIPRO SPOT-ON SOLUTION
FOR SMALL DOGS
EFFIPRO SPOT-ON SOLUTION
FOR EXTRA LARGE DOGS
EFFIPRO SPOT-ON SOLUTION
FOR LARGE DOGS
EFFIPRO SPOT-ON SOLUTION
FOR MEDIUM DOGS
EFFIPRO SPOT-ON SOLUTION
FOR CATS
EFFIPRO CUTANEOUS SPRAY
SOLUTION FOR CATS AND DOGS
ULTRATHOR WATER-BASED
TERMITICIDE
COUNTRY FIPRONIL RESIDUAL
TERMITICIDE
PURINA TOTALCARE FLEA SHIELD
65098
SPOT-ON FLEA TREATMENT FOR
SMALL DOGS
PURINA TOTALCARE FLEA SHIELD
65099
SPOT-ON FLEA TREATMENT FOR
MEDIUM DOGS
PURINA TOTALCARE FLEA SHIELD
65100
SPOT-ON FLEA TREATMENT FOR
CATS
PURINA TOTALCARE FLEA SHIELD
65101
SPOT-ON FLEA TREATMENT FOR
LARGE DOGS
65457
FRONTLINE ORIGINAL FOR CATS
VIRBAC (AUSTRALIA) PTY LTD
VIRBAC (AUSTRALIA) PTY LTD
VIRBAC (AUSTRALIA) PTY LTD
VIRBAC (AUSTRALIA) PTY LTD
VIRBAC (AUSTRALIA) PTY LTD
VIRBAC (AUSTRALIA) PTY LTD
ENSYSTEX AUSTRALASIA PTY LTD
GARRARDS PTY LTD
NESTLE PURINA PETCARE A DIV OF NESTLE
AUSTRALIA LTD
NESTLE PURINA PETCARE A DIV OF NESTLE
AUSTRALIA LTD
NESTLE PURINA PETCARE A DIV OF NESTLE
AUSTRALIA LTD
NESTLE PURINA PETCARE A DIV OF NESTLE
AUSTRALIA LTD
MERIAL AUSTRALIA PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
60
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Active number
Active name
Holder
65533
AMULET GEL INSECTICIDE
BASF AUSTRALIA LTD
65572
65655
65660
65661
65663
BLATTATHOR ULTRA GEL
COCKROACH BAIT
FRONTLINE ORIGINAL FOR LARGE
DOGS
FRONTLINE ORIGINAL FOR
MEDIUM DOGS
FRONTLINE ORIGINAL FOR SMALL
DOGS
FRONTLINE ORIGINAL FOR EXTRA
LARGE DOGS
EXELPET VET SERIES SPOT-ON
65778
FLEA TREATMENT FOR SMALL
DOGS
EXELPET VET SERIES SPOT-ON
65780
FLEA TREATMENT FOR LARGE
DOGS
EXELPET VET SERIES SPOT-ON
65781
FLEA TREATMENT FOR MEDIUM
DOGS
ENSYSTEX AUSTRALASIA PTY LTD
MERIAL AUSTRALIA PTY LTD
MERIAL AUSTRALIA PTY LTD
MERIAL AUSTRALIA PTY LTD
MERIAL AUSTRALIA PTY LTD
EXELPET PRODUCTS A DIV OF MARS
AUSTRALIA PTY LTD
EXELPET PRODUCTS A DIV OF MARS
AUSTRALIA PTY LTD
EXELPET PRODUCTS A DIV OF MARS
AUSTRALIA PTY LTD
HYMENOPTHOR ULTRA
65833
GRANULAR ANT AND
ENSYSTEX AUSTRALASIA PTY LTD
COCKROACH BAIT
MAGNATHOR MAGNETIC
66106
COCKROACH BAIT WITH
ENSYSTEX AUSTRALASIA PTY LTD
MAGTHANITE
66708
66878
67049
67629
68053
68276
APITHOR HIVE BEETLE
HARBOURAGE INSECTICIDE
HYMENOPTHOR MAGNETIC ANT
KILLER WITH MAGTHANITE
PROTECT-US PROFESSIONAL GEL
COCKROACH BAIT
SAS PRO PROFESSIONAL
GRANULE ANT KILLER
ATTRATHOR TARGETED
INSECTICIDE
GHARDA FIPRONIL 800 WG
INSECTICIDE
ENSYSTEX AUSTRALASIA PTY LTD
ENSYSTEX AUSTRALASIA PTY LTD
ENSYSTEX AUSTRALASIA PTY LTD
SUNDEW SOLUTIONS PTY LTD
ENSYSTEX AUSTRALASIA PTY LTD
GHARDA AUSTRALIA PTY LTD
68330
TOPBAIT GEL COCKROACH BAIT
BLANBON PTY LTD
68398
SUREFIRE TERMITICIDE
PCT HOLDINGS PTY LTD
68515
RADIATE TERMITICIDE
FMC AUSTRALASIA PTY LTD
68569
ACCENSI FIPRONIL RESIDUAL
TERMITICIDE
ACCENSI PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
61
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
68695
68749
68751
68911
68919
68941
68975
68977
69421
69450
69524
69556
69567
Agricultural and Veterinary Chemicals Code Act 1994
Active name
KENSO AGCARE BRUTUS 800
INSECTICIDE
APPARENT STRONG-WOOD
TERMITICIDE
APPARENT ONSLAUGHT
INSECTICIDE
COVERT GOLD COCKROACH GEL
BAIT
AC EMPORIUM 500 SEED
TREATMENT
FARMALINX CANNONBALL 200 SC
INSECTICIDE
Holder
KENSO CORPORATION (M) SDN. BHD.
APPARENT PTY. LTD.
APPARENT PTY. LTD.
PCT HOLDINGS PTY LTD
AXICHEM PTY LTD
FARMALINX PTY LTD
INSTAR GRANULAR INSECTICIDE
SUNDEW SOLUTIONS PTY LTD
ULTRAFORCE TERMITE FOAM
SHERWOOD CHEMICALS PUBLIC COMPANY
INSECTICIDE
LIMITED
HYMENOPTHOR ULTRA LIQUID
ANT KILLER
SINOCHEM SEEKER 200SC
INSECTICIDE
ENSYSTEX AUSTRALASIA PTY LTD
SINOCHEM AGRO CO., LTD
ULTRAFORCE AQUA TERMITICIDE
SHERWOOD CHEMICALS AUSTRALASIA PTY
& INSECTICIDE
LTD
ANTHEM 100 INSECTICIDE
ACCENSI FIPRONIL 200 SC
INSECTICIDE
69588
ULTRAFORCE DUST TERMITICIDE
69773
AC EMPORIUM INSECTICIDE
SHERWOOD CHEMICALS PUBLIC COMPANY
LIMITED
ACCENSI PTY LTD
SHERWOOD CHEMICALS PUBLIC COMPANY
LIMITED
AXICHEM PTY LTD
AMGROW PATROL FIXANT
69907
ADVANCED ANT SAND
SUNDEW SOLUTIONS PTY LTD
INSECTICIDE
69919
69924
70024
70090
70230
70278
70280
NUFARM MAESTRO 200SC
INSECTICIDE
NUFARM AUSTRALIA LIMITED
EXELPET VET SERIES SPOT-ON
EXELPET PRODUCTS A DIV OF MARS
FLEA TREATMENT FOR CATS
AUSTRALIA PTY LTD
COMBAT ANT-RID ANT KILLING
BAIT STRIPS
ULTRAFORCE COCKROACH BAIT
SUREFIRE FIPRONIL GRANULAR
ANT KILLER
LEGION INSECTICIDAL SEED
TREATMENT
MAESTRO 200SC INSECTICIDE
HENKEL AUSTRALIA PTY LTD
SHERWOOD CHEMICALS PUBLIC COMPANY
LIMITED
PCT HOLDINGS PTY LTD
CROP CARE AUSTRALASIA PTY LTD
NUFARM AUSTRALIA LIMITED
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
62
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
70308
80043
80096
Agricultural and Veterinary Chemicals Code Act 1994
Active name
COMBAT ROACH KILLING BAIT
STRIPS
Holder
HENKEL AUSTRALIA PTY LTD
ULTRAFORCE COCKROACH
SHERWOOD CHEMICALS PUBLIC COMPANY
POWDER
LIMITED
RULER 200 INSECTICIDE
GROW CHOICE PTY LIMITED
Methidathion
Registered products (along with their labels) included in the methidathion review
Active number
Active name
Holder
55599
SUPRATHION 400 EC INSECTICIDE
ADAMA AUSTRALIA PTY LIMITED
65291
AAKO RIDACIDE 400 EC
INSECTICIDE
AAKO AUSTRALIA PTY LIMITED
Methiocarb
Active constituent approvals included in the methiocarb review
Active number
Active name
Holder
44212
METHIOCARB
BAYER CROPSCIENCE PTY LTD
55824
METHIOCARB
BAYER CROPSCIENCE PTY LTD
Registered products (along with their labels) included in the methiocarb review
Active number
Active name
Holder
33274
MESUROL SNAIL AND SLUG BAIT
BAYER CROPSCIENCE PTY LTD
51851
BAYSOL SNAIL & SLUG BAIT
BAYER CROPSCIENCE PTY LTD
Molinate
Registered product (along with their labels) included in the molinate review
Active number
Active name
Holder
56744
SIRION HERBICIDE
SIPCAM PACIFIC AUSTRALIA PTY LTD
Neomycin
Registered products (along with their labels) included in the neomycin review
Active number
67805
Active name
ABBEYNEO ANTIBIOTIC FEED
ADDITIVE
Holder
ABBEY LABORATORIES PTY LTD
Omethoate
Active constituent approvals included in the omethoate review
Active number
Active name
Holder
59132
OMETHOATE
IMTRADE AUSTRALIA PTY LTD
69005
OMETHOATE
AGROSERVE PTY LTD
69935
OMETHOATE
ARYSTA LIFESCIENCE NORTH AMERICA LLC
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
63
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Registered products (along with their labels) included in the omethoate review
Active number
Active name
Holder
59576
ALL-MITEY 290 SL INSECTICIDE
CHEMINOVA AUSTRALIA PTY LIMITED
59872
61681
61682
62022
63676
65414
66938
68169
69096
69166
69636
69703
69899
70131
80532
CHEMAG SENTINEL 800
INSECTICIDE SPRAY
AW OMETHOATE 290 SL
INSECTICIDE
MITE MASTER 290 INSECTICIDE
4FARMERS OMETHOATE 290
INSECTICIDE
IMTRADE OMEN 290 INSECTICIDE
FARMALINX OMETHO-MITE 290 SL
INSECTICIDE
MISSION OMETHOATE 290
INSECTICIDE
IMTRADE AUSTRALIA PTY LTD
AGRI WEST PTY LIMITED
GROW CHOICE PTY LIMITED
4 FARMERS AUSTRALIA PTY LTD
IMTRADE AUSTRALIA PTY LTD
FARMALINX PTY LTD
MISSION BELL HOLDINGS PTY LTD
FMC OMETHOATE 290 MITICIDE
FMC AUSTRALASIA PTY LTD
RAINBOW OMETHOATE 290
SHANDONG RAINBOW INTERNATIONAL CO.,
INSECTICIDE
LTD
SABAKEM OMETHOATE 290SL
MITICIDE & INSECTICIDE
FOKUS 800 INSECTICIDE
CONQUEST OVID 290
INSECTICIDE
K-MITE 800 INSECTICIDE
APPARENT OMETHOATE 290
INSECTICIDE
GENFARM OMETHOATE 290
INSECTICIDE
SABAKEM PTY LTD
HEXTAR CHEMICALS PTY LTD
CONQUEST CROP PROTECTION PTY LTD
SHANDONG RAINBOW INTERNATIONAL CO.,
LTD
APPARENT PTY. LTD.
LANDMARK OPERATIONS LIMITED
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
64
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Paraquat
Active constituent approvals included in the paraquat review
Active number
44249
44387
47747
48278
51041
51678
52712
53214
54043
54131
55327
55682
55966
56809
58230
59171
64565
64765
69493
70155
80528
Active name
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
Holder
SYNGENTA AUSTRALIA PTY LTD
NUFARM AUSTRALIA LIMITED
UPL AUSTRALIA LIMITED
SYNGENTA AUSTRALIA PTY LTD
RONIC INTERNATIONAL PTY LIMITED
UNISUN CHEMICALS PTY LTD
GRIFFIN CORPORATION AUSTRALIA PTY LTD
GRIFFIN CORPORATION AUSTRALIA PTY LTD
PARAQUAT DICHLORIDE
HALLEY INTERNATIONAL ENTERPRISE
MANUFACTURING CONCENTRATE
(AUSTRALIA) PTY LTD
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
PARAQUAT DICHLORIDE
MANUFACTURING CONCENTRATE
WELLFARM PARAQUAT 250 SL
HERBICIDE
MISSION PARAGLIDE HERBICIDE
CAPITAL COMMODITIES (VIC) PTY. LTD
ADAMA AUSTRALIA PTY LIMITED
IMTRADE AUSTRALIA PTY LTD
SYNGENTA AUSTRALIA PTY LTD
CONQUEST CROP PROTECTION PTY LTD
SINON AUSTRALIA PTY LIMITED
AGROGILL CHEMICALS PTY LTD
CHEMINOVA AUSTRALIA PTY LIMITED
SHARDA WORLDWIDE EXPORTS PVT LTD
GROW CHOICE PTY LIMITED
WELLFARM PTY LTD
MISSION BELL HOLDINGS PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
65
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Registered products (along with their labels) included in the paraquat review
Active number
51958
52141
Active name
ACCENSI PARAQUAT 250
HERBICIDE
KENDON SPRAYQUAT 250
HERBICIDE
Holder
ACCENSI PTY LTD
KENDON CHEMICALS & MNFG CO PTY LTD
NUFARM NUQUAT 250 NON53221
RESIDUAL KNOCKDOWN
NUFARM AUSTRALIA LIMITED
HERBICIDE
53381
53919
54520
54522
56102
57817
58075
58734
58841
IMTRADE PARAQUAT 250
HERBICIDE
IMTRADE AUSTRALIA PTY LTD
SHIRQUAT 250 HERBICIDE
CROP CARE AUSTRALASIA PTY LTD
HALLEY PARAQUAT 250
HALLEY INTERNATIONAL ENTERPRISE
HERBICIDE
(AUSTRALIA) PTY LTD
SPRAYTOP 250 SL HERBICIDE
ADAMA AUSTRALIA PTY LIMITED
KENSO AGCARE PARA-KEN 250
HERBICIDE
CONQUEST EXPLODE 250
HERBICIDE
RAVENSDOWN PARAQUAT 250
HERBICIDE
4FARMERS PARAQUAT 250
HERBICIDE
GENFARM PARAQUAT 250
HERBICIDE
KENSO CORPORATION (M) SDN. BHD
CONQUEST CROP PROTECTION PTY LTD
MACROFERTIL AUSTRALIA PTY LTD
4 FARMERS AUSTRALIA PTY LTD
LANDMARK OPERATIONS LIMITED
58992
SINMOSA 250 HERBICIDE
SINON AUSTRALIA PTY LIMITED
59078
RYGEL PARAQUAT 250 HERBICIDE
PROFENG AUSTRALIA PTY LTD
59418
INFERNO HERBICIDE
SIPCAM PACIFIC AUSTRALIA PTY LTD
60444
60473
FORWARD PARAQUAT 250
HERBICIDE
CHEMINOVA PARAQUAT 250 SL
HERBICIDE
FORWARD AUSTRALIA PTY LTD
CHEMINOVA AUSTRALIA PTY LIMITED
61254
BIOTIS PARAQUAT 250 HERBICIDE
BIOTIS LIFE SCIENCE PTY LTD
61869
TITAN PARAQUAT 250 HERBICIDE
TITAN AG PTY LTD
62042
CROP CARE ALLIANCE HERBICIDE
CROP CARE AUSTRALASIA PTY LTD
62096
62540
63090
CHOICE PARAQUAT 250
HERBICIDE
CHEMFORCE PARAQUAT 250
HERBICIDE
OZCROP PARAQUAT 250
HERBICIDE
GROW CHOICE PTY LIMITED
CHEMFORCE 2010 PTY LTD
OZCROP PTY. LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
66
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Agricultural and Veterinary Chemicals Code Act 1994
Active number
Active name
Holder
63565
OZCROP BLOWOUT HERBICIDE
OZCROP PTY. LTD
63617
QUASH 250 HERBICIDE
HEXTAR CHEMICALS PTY LTD
64281
64430
64588
64651
64706
64731
FARMALINX PARQUAT 250
HERBICIDE
KENSO AGCARE PARA-KEN 334
HERBICIDE
SMART PARAQUAT 250
HERBICIDE
RC PARAQUAT 250 HERBICIDE
FOSTERRA PARAQUAT 250
HERBICIDE
AGRO-ESSENCE PARAQUAT
250SL
65148
TRIO PARAQUAT 250 HERBICIDE
65149
PRO PARAQUAT 250 HERBICIDE
65524
65537
65694
65713
65839
66103
66249
66309
66531
66548
66809
66853
67163
67307
PROTERRA PARAQUAT 250
HERBICIDE
SANONDA HERBICIDE PARAQUAT
250SL
FARMALINX PTY LTD
KENSO CORPORATION (M) SDN. BHD
CROP SMART PTY LTD
RURALCHEM PTY LTD
FOSTERRA PTY LTD
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
AUSTRALIAN PROGRESSIVE SUPPLIES PTY
LTD
AUSTRALIAN PROGRESSIVE SUPPLIES PTY
LTD
PROTERRA PTY LTD
SANONDA (AUSTRALIA) PTY LTD
RAINBOW PARAQUAT 250 SL
SHANDONG RAINBOW INTERNATIONAL CO.,
HERBICIDE
LTD
PACIFIC PARAQUAT 250
HERBICIDE
MACPHERSONS PARAQUAT 250
HERBICIDE
APPARENT PARAQUAT 250
HERBICIDE
AW PUTOUT 250 HERBICIDE
AGSPRAY PARAQUAT 250
HERBICIDE
ACP PARAQUAT 250 HERBICIDE
ECHEM PARAQUAT 250
HERBICIDE
KEY PARAQUAT 250 HERBICIDE
MISSION PARAQUAT 250
HERBICIDE
EASYFARM PARAQUAT 250 SL
HERBICIDE
AC PISTON 250 HERBICIDE
PACIFIC AGRISCIENCE PTY LTD
RONIC INTERNATIONAL PTY LIMITED
APPARENT PTY. LTD
AGRI WEST PTY LIMITED
AGKARE PTY LTD
AUSTRALIS CROP PROTECTION PTY LTD
ECHEM (AUST) PTY LIMITED
KEYPORT NOMINEES PTY LTD
MISSION BELL HOLDINGS PTY LTD
EASYFARM PTY LTD
AXICHEM PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
67
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
67344
Agricultural and Veterinary Chemicals Code Act 1994
Active name
IMTRADE PARA-TROOPER
HERBICIDE
Holder
IMTRADE AUSTRALIA PTY LTD
67437
AGROQUAT 250 HERBICIDE
AGROGILL CHEMICALS PTY LTD
67563
FMC PARAQUAT 250 HERBICIDE
FMC AUSTRALASIA PTY LTD
67650
67888
67977
68112
68196
68477
68577
69274
AUSAGRI PARAQUAT 250
HERBICIDE
SPALDING PARAQUAT 250
HERBICIDE
EZYCROP PARAQUAT 250 SL
HERBICIDE
AUSAGRI IP PTY LTD
SPALDING HOLDINGS PTY. LTD
EZYCROP PTY LTD
CROPPRO PARAQUAT 250 SL
ZHEJIANG XINAN CHEMICAL INDUSTRIAL
HERBICIDE
GROUP CO., LTD
NOVAGUARD PARAQUAT 250 SL
HERBICIDE
AGMATE PARAQUAT 250 SL
HERBICIDE
GRAMOXONE 360 PRO HERBICIDE
SABAKEM PARAQUAT 250SL
HERBICIDE
NOVAGUARD PTY LTD
AGCARE PTY LTD
SYNGENTA AUSTRALIA PTY LTD
SABAKEM PTY LTD
69382
JNO PARAQUAT 250 HERBICIDE
JNO INVESTMENT HOLDINGS PTY LTD
69502
CRUZE 300 HERBICIDE
SPALDING HOLDINGS PTY. LTD.
69712
PARADOX 250 HERBICIDE
SINON AUSTRALIA PTY LIMITED
MACRO PROTECT PARAQUAT 250
LOUIS DREYFUS COMMODITIES AUSTRALIA
SL HERBICIDE
PTY. LTD
69833
69986
70143
70305
AGVANTAGE PARAQUAT 250 SL
HERBICIDE
FARMALINX POWERQUAT 300 SL
HERBICIDE
CHEMINOVA PARAQUAT 350 SL
HERBICIDE
LANDMARK OPERATIONS LIMITED
FARMALINX PTY LTD
CHEMINOVA AUSTRALIA PTY LIMITED
Registered paraquat and diquat combination products (along with their labels) included in the paraquat review
Active number
64704
58336
58412
58470
58728
Active name
FOSTERRA PARAQUAT / DIQUAT
HERBICIDE
HALLEY PREMIER 250 HERBICIDE
IMTRADE SPRAYKILL 250
HERBICIDE
CONQUEST SCORCHER 250
HERBICIDE
MACPHERSONS PARADYM 250
HERBICIDE
Holder
FOSTERRA PTY LTD
HALLEY INTERNATIONAL ENTERPRISE
(AUSTRALIA) PTY LTD
IMTRADE AUSTRALIA PTY LTD
CONQUEST CROP PROTECTION PTY LTD
RONIC INTERNATIONAL PTY LIMITED
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
68
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
58733
Agricultural and Veterinary Chemicals Code Act 1994
Active name
4FARMERS BROWN OUT 250
HERBICIDE
Holder
4 FARMERS AUSTRALIA PTY LTD
58908
RYGEL PRE-SEED 250 HERBICIDE
PROFENG AUSTRALIA PTY LTD
59098
SPRAY-PLANT 250 HERBICIDE
SIPCAM PACIFIC AUSTRALIA PTY LTD
59311
NUFARM REVOLVER HERBICIDE
NUFARM AUSTRALIA LIMITED
59333
59878
59879
60287
60991
61138
KENSO AGCARE SPEEDY 250
HERBICIDE
GENFARM DI-PAR 250 HERBICIDE
FARMOZ SPRAY & SOW
HERBICIDE
COMBIK 250 HERBICIDE
OSPRAY SPRAY-OUT 250
HERBICIDE
RAVENSDOWN WILDFIRE 250
HERBICIDE
KENSO CORPORATION (M) SDN. BHD
LANDMARK OPERATIONS LIMITED
ADAMA AUSTRALIA PTY LIMITED
SINON AUSTRALIA PTY LIMITED
CHEMINOVA AUSTRALIA PTY LIMITED
MACROFERTIL AUSTRALIA PTY LTD
61460
ALARM HERBICIDE
SIPCAM PACIFIC AUSTRALIA PTY LTD
61860
TITAN EOS HERBICIDE
TITAN AG PTY LTD
62495
62631
SANONDA PARAQUAT/DIQUAT
HERBICIDE
ACCENSI PARAQUAT/DIQUAT 250
HERBICIDE
SANONDA (AUSTRALIA) PTY LTD
ACCENSI PTY LTD
63274
UNI-SPRAY 250 HERBICIDE
UPL AUSTRALIA LIMITED
63565
OZCROP BLOWOUT HERBICIDE
OZCROP PTY. LTD.
64325
FARMALINX PARADAT HERBICIDE
FARMALINX PTY LTD
NAADCO PARAQUAT DIQUAT 250
NEW AUSTRALIA AGRICULTURAL
HERBICIDE
DEVELOPMENT COMPANY PTY LTD
KWICKNOCK 250 HERBICIDE
GROW CHOICE PTY LIMITED
RAINBOW DIQU-PARA 250
SHANDONG RAINBOW INTERNATIONAL CO.,
HERBICIDE
LTD
64549
64802
65295
65708
66197
66327
PACIFIC DIQUAT/PARAQUAT 250
HERBICIDE
UNITED PHOSPHORUS UNISPRAY
250 HERBICIDE
AW DISMANTLE HERBICIDE
PACIFIC AGRISCIENCE PTY LTD
UPL AUSTRALIA LIMITED
AGRI WEST PTY LIMITED
AGRO-ESSENCE
66788
PARAQUAT+DIQUAT 250
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
HERBICIDE
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
69
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
66852
67323
67399
67562
67627
67707
67891
68075
68125
68202
68280
68479
80357
Agricultural and Veterinary Chemicals Code Act 1994
Active name
MISSION PARA-DIQUAT 250 SC
HERBICIDE
FORWARD PARAQUAT + DIQUAT
HERBICIDE
EASYFARM PARAQUAT-DIQUAT
250 HERBICIDE
FMC PARAQUAT + DIQUAT
HERBICIDE
APPARENT PARAQUAT 135 +
DIQUAT 115 HERBICIDE
SMART COMBINATION 250
HERBICIDE
SPALDING EXOCET 250
HERBICIDE
EZYCROP PARAQUAT-DIQUAT 250
HERBICIDE
DIBROMQUAT 250 HERBICIDE
NOVAGUARD PARAQUAT-DIQUAT
250 HERBICIDE
AGRO BURNER 250 HERBICIDE
AGMATE PARAQUAT & DIQUAT
250 SL HERBICIDE
AGVANTAGE DI-PAR 250
HERBICIDE
Holder
MISSION BELL HOLDINGS PTY LTD
FORWARD AUSTRALIA PTY LTD
EASYFARM PTY LTD
FMC AUSTRALASIA PTY LTD
APPARENT PTY. LTD
CROP SMART PTY LTD
SPALDING HOLDINGS PTY. LTD
EZYCROP PTY LTD
HEXTAR CHEMICALS PTY LTD
NOVAGUARD PTY LTD
AGROGILL CHEMICALS PTY LTD
AGCARE PTY LTD
LANDMARK OPERATIONS LIMITED
Polihexanide
Registered products (along with their labels) included in the polihexanide review
Active number
59720
59949
59998
60080
Active name
F10SCXD VETERINARY
DISINFECTANT CLEANSER
Holder
HEALTH AND HYGIENE (PTY) LTD
AQUASPA BY LO-CHLOR SPA
M I INTERNATIONAL PTY LTD T/A LO-CHLOR
SANITISER
CHEMICALS
TRIGENE II VIRUCIDAL
DISINFECTANT CONCENTRATE
DERMCARE OTOFLUSH
CEVA ANIMAL HEALTH PTY LTD
DERMCARE-VET PTY. LTD
CLARK RUBBER FILTRITE SANIT61106
EEZY FOR FAMILY POOLS EEZY
CLARK RUBBER FRANCHISING PTY LTD
SANITISER
62103
64278
64823
MICROTECH 7000 GENERAL
PURPOSE DISINFECTANT
NATURE SPA SPA WATER
TREATMENT & SANITISER
CLARK RUBBER FILTRITE SANITEEZY EEZY SANITISER
CHEMETALL (AUSTRALASIA) PTY LTD
ENVIRO SPA & POOL PTY LTD
CLARK RUBBER FRANCHISING PTY LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
70
Commonwealth of Australia Gazette
No. APVMA 16, Tuesday, 11 August 2015
Active number
66624
66943
Agricultural and Veterinary Chemicals Code Act 1994
Active name
Holder
CRYSTAL WATERS SPA
M I INTERNATIONAL PTY LTD T/A LO-CHLOR
SANITISER
CHEMICALS
CRYSTAL WATERS POOL
M I INTERNATIONAL PTY LTD T/A LO-CHLOR
SANITISER
CHEMICALS
FILTRITE SANIT-EEZY EEZY
68964
SANITISER FOR SPAS SPA
CLARK RUBBER FRANCHISING PTY LTD
SANITISER
Procymidone
Registered products (along with their labels) included in the procymidone review
Active number
59268
63494
64293
65892
67183
67536
69208
69322
80001
Active name
GENFARM PROFLEX 500
FUNGICIDE
ACCENSI PROCYMIDONE 500
FUNGICIDE
FARMALINX METAPRIS FUNGICIDE
TITAN PROCYMIDONE 500
FUNGICIDE
4FARMERS PROCYMIDONE 500 SC
SEED DRESSING
4FARMERS PROCYMIDONE 500
FUNGICIDE
APPARENT PROCYMIDONE 500
FUNGICIDE
FARMALINX METAPRIS 500 SC
FUNGICIDE
PROCLEX 500 FUNGICIDE
Holder
LANDMARK OPERATIONS LIMITED
ACCENSI PTY LTD
FARMALINX PTY LTD
TITAN AG PTY LTD
4 FARMERS AUSTRALIA PTY LTD
4 FARMERS AUSTRALIA PTY LTD
APPARENT PTY. LTD.
FARMALINX PTY LTD
SHANDONG RAINBOW INTERNATIONAL CO.,
LTD
Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations
71