APVMA Gazette No. 16, 11 August 2015...Date of registration/approval: 28 July 2015 Product registration no.: 81041 Label approval no.: 81041/102204 2. AGRICULTURAL PRODUCTS BASED ON

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: [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/


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.


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


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 name: Baracuda Weekly Chlorine Tablets

Active constituent/s: 900 g/kg chlorine present as trichloroisocyanuric acid

Applicant name: Zodiac Group Australia Pty Ltd


Summary of use For the control of bacteria, viruses and algae in swimming pools





Product name: Baracuda Salt Water Boost

Active constituent/s: 504 g/kg sodium dichlorisocyanurate; also contains 100 g/kg sodium tetraborate pentahydrate



Summary of use For the control of bacteria and algae in outdoor swimming pools







Product name: R70 Spa Chlor

Active constituent/s: 350 g/kg available chlorine (Cl) present as lithium hypochlorite

Applicant name: Pool Resources Pty Limited


Summary of use: For the control of bacteria, viruses and algae in spas and kills blackspot algae





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


Summary of use: For the control of a wide range of annual and perennial broadleaf weeds





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





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


Summary of use: For the control of weeds





Product name: Surefire Pro Cockroach Gel Bait

Active constituent/s: 0.5 g/kg fipronil

Applicant name: PCT Holdings Pty Ltd


Summary of use: For the treatment of cockroach infestations in urban situations







Product name: Crossbar 240 Selective Herbicide

Active constituent/s: 240 g/L oxyfluorfen

Applicant name: UPL Australia Limited


Summary of use For the selective control of certain broadleaf and grass weeds in various situations





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


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





Product name: Baracuda Xtreme Shock

Active constituent/s: 700 g/kg available chlorine (Cl) present as calcium hypochlorite



Summary of use: For controlling bacteria and algae in swimming pools





Product name: 4Farmers Amitrole 250 Herbicide

Active constituent/s: 250 g/L amitrole

Applicant name: 4 Farmers Australia Pty Ltd


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





Product name: AC Petulant 250 EC Fungicide

Active constituent/s: 250 g/L Propiconazole

Applicant name: Axichem Pty Ltd


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







Product name: Bachlor 125 SC Fungicide

Active constituent/s: 125 g/L epoxiconazole

Applicant name: AAKO Australia Pty Limited


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



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 name: Methograin IGR Grain Protectant

Active constituent/s: 30 g/L (s)-methoprene


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’





Product name: Methograin IGR 300 Grain Protectant

Active constituent/s: 300 g/L (s)-methoprene


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’







Product name: Nail 600EC Herbicide

Active constituent/s: 600 g/L carfentrazone-ethyl

Applicant name: Crop Care Australasia Pty Ltd


Summary of variation: To amend the solvent statement on the label





Product name: Monaco Herbicide

Active constituent/s: 750 g/kg sulfosulfuron

Applicant name: Crop Culture Pty Ltd


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘CROP CULTURE MONACO HERBICIDE’ to ‘MONACO HERBICIDE’





Product name: Steer 750 Herbicide

Active constituent/s: 750 g/kg quinclorac

Applicant name: Turf Culture Pty Ltd


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





Product name: Unimaz 250 SL Herbicide

Active constituent/s: 250 g/L imazapyr present as isopropylamine salt

Applicant name: UPL Australia Limited


Summary of variation: To amend the label to include lockable irrigation channels in settling ponds





Product name: Mortein Peaceful Nights Mosquito and Fly Repellent

Active constituent/s: 99 g/L transfluthrin

Applicant name: Reckitt Benckiser (Australia) Pty Limited


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’







Product name: Rotary Max Herbicide

Active constituent/s: 240 g/L imazapyr present as isopropylamine salt

Applicant name: Adama Australia Pty Limited


Summary of variation: To amend the current uses to include irrigation channels and add the control of rubber vine and thumbergia





Product name: Merit Turf and Ornamental Insecticide

Active constituent/s: 200 g/L imidacloprid

Applicant name: Bayer CropScience Pty Ltd


Summary of variation: To change the pack range to 1 L–5 L





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


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




Veterinary Chemical Products and Approved Labels



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


Product name: Carbidox 1000

Active constituent/s: 980 g/kg nicarbazin

Applicant name: Dox-al Australia Pty Ltd


Summary of use: For the prevention of coccidiosis in broiler chickens





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


Summary of use Oral solution product for the treatment of sensitive strains of roundworms in pigs and poultry





Product name: Independents Own Fenbender 100 Oral Drench for Cattle and Horses

Active constituent/s: 100 g/L fenbendazole

Applicant name: Apparent Pty. Ltd


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




2. VARIATIONS OF REGISTRATION


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)


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’







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)


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’




3. VARIATION OF LABEL APPROVAL


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


Summary of variation: To update the claims to include use in large breed dogs with preclinical DCM





Approved Active Constituents

Approved Active Constituents


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


Active constituent/s: Dicamba

Applicant name: Adama Australia Pty Limited


Summary of use: For use in agricultural chemical products

Date of approval: 22 July 2015

Approval no.: 80526


Active constituent/s: Florasulam

Applicant name: Dow AgroSciences Australia Limited


Summary of use: For use in agricultural chemical products

Date of approval: 29 July 2015

Approval no.: 80078


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


mailto:[email protected]


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.



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.



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.



(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:


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:


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



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



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



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


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4700

Fax: +61 2 6210 4741


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


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



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:



(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.



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.



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.



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



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


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4700

Fax: +61 2 6210 4741




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


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4897

Fax: +61 2 6210 4840


http://www.comlaw.gov.au/Current/F2012L02501http://www.comlaw.gov.au/Current/F2012L02501http://www.comlaw.gov.au/mailto:[email protected]


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.



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



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



Bulb vegetables 0.5

Herbs 15

Leafy vegetables [except brassica leafy vegetables; lettuce, head; lettuce, leaf]

5

Lettuce, leaf 15

Rhubarb 5



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.


MRL Contact Officer


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4897

Fax: +61 2 6210 4840




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.


Residues Contact Officer


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4897

Fax: +61 2 6210 4840


http://www.comlaw.gov.au/mailto:[email protected]



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



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.



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

Documents

APVMA Gazette No. 16, 11 August 2015...Date of registration/approval: 28 July 2015 Product registration no.: 81041 Label approval no.: 81041/102204 2. AGRICULTURAL PRODUCTS BASED ON