APVMA Gazette No. 16, 11 August 2015...Date of registration/approval: 28 July 2015 Product...
Transcript of APVMA Gazette No. 16, 11 August 2015...Date of registration/approval: 28 July 2015 Product...
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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
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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: [email protected]
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.
mailto:[email protected]://www.apvma.gov.au/http://www.apvma.gov.au/publications/gazette/
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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.
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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
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. 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 For the protection of structures from subterranean termite damage and for the control of termites and a range of other urban pests
Date of registration/approval: 28 July 2015
Product registration no.: 81041
Label approval no.: 81041/102204
2. 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
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 5
Agricultural Chemical Products and Approved Labels
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: For the control of bacteria, viruses and algae in spas and kills blackspot algae
Date of registration/approval: 23 July 2015
Product registration no.: 80633
Label approval no.: 80633/101313
Application no.: 101477
Product name: Apparent Ramjet 75-D Herbicide
Active constituent/s: 300 g/L 2,4-D, present as the triisopropanolamine salt , 75 g/L picloram, present as the triisopropanolamine salt
Applicant name: 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: For the control of weeds
Date of registration/approval: 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
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 6
Agricultural Chemical Products and Approved Labels
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 For the selective control of certain broadleaf and grass weeds in various situations
Date of registration/approval: 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: 079 875 184
Summary of use: 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
Date of registration/approval: 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: 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
Date of registration/approval: 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: For the control of certain fungal diseases of bananas, peanuts, pineapples, stone fruit, sugar cane, wheat and other crops in certain states
Date of registration/approval: 30 July 2015
Product registration no.: 81115
Label approval no.: 81115/102344
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 7
Agricultural Chemical Products and Approved Labels
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 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
Date of registration/approval: 3 August 2015
Product registration no.: 80541
Label approval no.: 80541/101074
3. 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: N/A
Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RENTOKIL FENITROTHION 1000 INSECTICIDE’ to ‘METHOGRAIN FENITROTHION 1000 INSECTICIDE’
Date of variation: 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: N/A
Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RENTOKIL IGR GRAIN PROTECTANT’ to ‘METHOGRAIN IGR GRAIN PROTECTANT’
Date of variation: 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: N/A
Summary of variation: 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’
Date of variation: 21 July 2015
Product registration no.: 61969
Label approval no.: 61969/103314
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 8
Agricultural Chemical Products and Approved Labels
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: 142 860 473
Summary of variation: To change the distinguishing name and the name that appears on the label from ‘CROP CULTURE MONACO HERBICIDE’ to ‘MONACO HERBICIDE’
Date of variation: 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: 003 274 655
Summary of variation: 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’
Date of variation: 28 July 2015
Product registration no.: 68926
Label approval no.: 68926/103380
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 9
Agricultural Chemical Products and Approved Labels
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
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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
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. 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
2. 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: 000 138 714
Summary of variation: 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’
Date of variation: 24 July 2015
Product registration no.: 80141
Label approval no.: 80141/103352
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 11
Veterinary Chemical Products and Approved Labels
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: 000 138 714
Summary of variation: 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’
Date of variation: 24 July 2015
Product registration no.: 80143
Label approval no.: 80143/103350
3. 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
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 12
Approved Active Constituents
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
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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
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: [email protected]
mailto:[email protected]
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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
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-1-
yl]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.
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 15
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
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.
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 16
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
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.
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 17
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
(iii) 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
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 18
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
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
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 19
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
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
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 20
Telmisartan in SEMINTRA 4MG/ML ORAL SOLUTION FOR CATS
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: [email protected]
1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.
mailto:[email protected]://www.comlaw.gov.au/ComLaw/Legislation/ActCompilation1.nsf/current/bytitle/A06DDA96E680781ECA2573120082EBE6?OpenDocument&mostrecent=1
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 21
Buprenorphine in BUPREDYNE INJECTION
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-14α-
morphinan-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-3-
hydroxy-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.
http://www.pharmacopoeia.co.uk/bp2015updated/ixbin/bp.cgi?a=imagezoom&file=bp2015_v1_07_medicinal_and_pharmaceutical_substances_03/large/buprenorphine_hydrochloride_cf1181-b.png
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 22
Buprenorphine in BUPREDYNE INJECTION
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:
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 23
Buprenorphine in BUPREDYNE INJECTION
(i) 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.
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 24
Buprenorphine in BUPREDYNE INJECTION
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 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.
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 25
Buprenorphine in BUPREDYNE INJECTION
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.
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 26
Buprenorphine in BUPREDYNE INJECTION
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.
http://www.comlaw.gov.au/ComLaw/Legislation/ActCompilation1.nsf/current/bytitle/A06DDA96E680781ECA2573120082EBE6?OpenDocument&mostrecent=1
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 27
Buprenorphine in BUPREDYNE INJECTION
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: [email protected]
mailto:[email protected]
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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
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: [email protected]
http://www.comlaw.gov.au/Current/F2012L02501http://www.comlaw.gov.au/Current/F2012L02501http://www.comlaw.gov.au/mailto:[email protected]
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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
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.
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 30
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
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 1
Cassava T1
Potato 1
Radish T1
Swede T1
Sweet potato T1
Taro T1
Turnip, garden 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 vegetables; lettuce, head]
5
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)
10
Table grapes 2
Iprodione
Iprodione
Pistachio nut T0.2
Methomyl
Methomyl
Chard 2
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 31
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
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 seeds)
T*0.05
Methomyl
Methomyl
Ginger, Japanese T2
Onion, Chinese T1
Root and tuber vegetables 1
Methoxyfenozide
Methoxyfenozide
Podded pea (young pods) (snow and sugar snap)
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 leafy vegetables; lettuce, head; lettuce, leaf]
5
Lettuce, leaf 15
Rhubarb 5
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 32
Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code
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: [email protected]
mailto:[email protected]
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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
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: [email protected]
http://www.comlaw.gov.au/mailto:[email protected]
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 34
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code
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
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 35
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code
Part 1 Preliminary
1 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 Variations to Standard 1.4.2—Maximum
Residue Limits
5 Variations to Standard 1.4.2
The Schedule to this Instrument sets out the variations made to the Principal Instrument by this Amendment Instrument.
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Commonwealth of Australia Gazette No. APVMA 16, Tuesday, 11 August 2015 Agricultural and Veterinary Chemicals Code Act 1994 36
Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code
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 definiti