APVMA Gazette No. 9, 3 May 2016 · 2016. 5. 3. · No. APVMA 9, Tuesday, 3 May 2016 Published by The Australian Pesticides and Veterinary Medicines Authority AGRICULTURAL AND VETERINARY

No. APVMA 9, Tuesday, 3 May 2016

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 9, Tuesday, 3 May 2016 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2016

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:

Director, Public Affairs and Communications

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 granted by the APVMA, notices as required

by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material

issued by the APVMA.

Pursuant to section 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/news-and-publications/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 4988

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/news-and-publications/publications/gazette


CONTENTS

Erratum Notice ....................................................................................................................................................................... 3 Agricultural Chemical Products and Approved Labels............................................................................................................ 4 Veterinary Chemical Products and Approved Labels ........................................................................................................... 13 Approved Active Constituents .............................................................................................................................................. 16 Amendments to the APVMA MRL Standard ......................................................................................................................... 18 Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code ........................................................ 19 Variations to Schedule 20 of the Australia New Zealand Food Standards Code .................................................................. 23 Cancellation of Registration at the Request of the Holder .................................................................................................... 29 Cancellation of Label Approval at the Request of the Holder ............................................................................................... 30

Erratum Notice

The Australian Pesticides and Veterinary Medicines Authority advises that an error was published in the Commonwealth

of Australia Gazette for Agricultural and Veterinary Chemicals, APVMA No. 8, Tuesday, 19 April 2016.

In the Notice, the active constituent unit was incorrect.

The correct entry for the Notice of Registration for ‘EXELPET INTESTINAL ALL-WORMER TABLETS FOR DOGS’ is on

page 13 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.: 100372

Product name: RHDV K5

Active constituent/s: Rabbit Haemorrhagic Disease Virus, 08q712 strain >30,000 id50 units

Applicant name: NSW Department Of Primary Industries

Applicant ACN: N/A

Summary of use For the control of infection of wild European rabbits

Date of registration/approval: 21 April 2016

Product registration no.: 80188

Label approval no.: 80188/100372

2. AGRICULTURAL PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS


Product name: Deluge TX Surfactant

Active constituent/s: 1040 g/L octyl phenol ethoxylate

Applicant name: Victorian Chemical Company Proprietary Limited

Applicant ACN: 004 188 863

Summary of use For use as wetting agent / surfactant for use with glyphosate herbicides




3. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Agro-Essence Boxmate A Herbicide

Active constituent/s: 960 g/L s-metolachlor

Applicant name: Agro-Alliance (Australia) Pty Ltd


Summary of use For the control of certain annual grasses and broadleaf weeds in certain crops





Product name: Time's Up Fast Action Baited Mouse Station

Active constituent/s: 0.05 g/kg brodifacoum

Applicant name: Pelgar International (Aus) Pty Ltd


Summary of use For the control of mice in various urban situations







Product name: Relyon Steady 750WG Herbicide

Active constituent/s: 750 g/kg isoxaflutole

Applicant name: Ruralco Holdings Limited


Summary of use For the control and suppression of various broadleaf weeds and grasses in sugercane and chickpeas





Product name: Centurion Xtra Herbicide

Active constituent/s: 360 g/L clethodim

Applicant name: Arysta Lifescience Australia Pty Ltd


Summary of use For the control of certain weeds in beetroot, cabbage, canola, celery, cotton, forestry, lettuce, non-bearing fruit trees, onions, ornamentals, peanuts, pulses, potatoes, soybeans and pasture legume, seed crops





Product name: Fairway Selective Herbicide

Active constituent/s: 280 g/L mcpa present as the iso-octyl ester 140 g/L bromoxynil present as the octanoate ester 40 g/L dicamba present as the acid

Applicant name: Adama Australia Pty Limited


Summary of use For the control of certain broadleaf weeds in wheat, barley, cereal rye, oats, triticale and turf





Product name: AC Fend Flowable Seed Dressing

Active constituent/s: 25 g/L tebuconazole 4 g/L cypermethrin

Applicant name: Axichem Pty Ltd


Summary of use For the control of a range of fungi and insects in wheat, oats and barley





Product name: Hovex Vaporgard Outdoor Fly & Mosquito Shield

Active constituent/s: 0.5 g/kg permethrin, 5 g/kg transfluthrin

Applicant name: Pascoe's Pty Ltd


Summary of use For the use as a repellent of flying insects for up to six hours







Product name: Chemforce Ammonium Sulphate Herbicide Adjuvant

Active constituent/s: 980 g/kg ammonium sulphate

Applicant name: Chemforce 2010 Pty Ltd


Summary of use For the use of minimising antagonism when tank mixing with flowable herbicides and to improve performance under adverse environmental conditions





Product name: Precare 500 SC Herbicide

Active constituent/s: 500 g/L propyzamide.

Applicant name: Shandong Rainbow International Co., Ltd

Applicant ACN: N/A

Summary of use For the selective control of certain grasses and broad leaf weeds in lettuce,

sports turf, home lawns and legume seed crops and pastures





Product name: Ozcrop Hexazinone 750 SG Herbicide

Active constituent/s: 750 g/kg hexazinone

Applicant name: Ozcrop Pty Ltd


Summary of use For the control of certain sedges, perennial grasses, broadleaf and woody weeds in

pinus radiata forests and industrial weed control





Product name: AC Haven Flowable Seed Dressing

Active constituent/s: 4 g/L cypermethrin and 150 g/L tridimenol

Applicant name: Axichem Pty Ltd


Summary of use For the control of various fungi and insects





Product name: Raid One Shot Crawling Insects Surface Spray Targetkill

Active constituent/s: 2.0 g/kg cypermethrin, 0.7 g/kg imiprothrin

Applicant name: S.C. Johnson & Son Pty Ltd


Summary of use For the control of cockroaches, ants, spiders, silverfish, fleas, clothes moths, carpet beetles and millipedes in household situations







Product name: ACP Diuron 900 WG Herbicide

Active constituent/s: 900 g/kg diuron

Applicant name: Australis Crop Protection Pty Ltd


Summary of use For selective weed control in various situations





Product name: Shamal 500 WG Herbicide

Active constituent/s: 500 g/kg propyzamide

Applicant name: Rotam Agrochemical Co., Ltd


Summary of use For the selective control of certain grasses and broad leaf weeds in lettuce, sports turf, home lawns and legume seed crops and pastures





Product name: Amgrow Feeder Weeder Hose On

Active constituent/s: 15 g/L MCPA present as dimethylamine salt, 2.3 g/L dicamba present as

dimethylamine salt

Applicant name: Amgrow Pty Ltd


Summary of use For killing broadleaf weeds and feeding the lawn





Product name: Nufarm PreCut Plant Growth Regulator

Active constituent/s: 100 g/kg prohexadione-calcium

Applicant name: Nufarm Australia Limited


Summary of use For the use of reduction of shoot growth in apples





Product name: ACP MCPA 750 Selective Herbicide

Active constituent/s: 750 g/L MCPA present as the dimethylamine salt

Applicant name: Australis Crop Protection Pty Ltd


Summary of use For the selective control of broadleaf weeds in cereals, linseed, oilseed poppies,

pastures, rice, sugarcane and turf







Product name: Freezone Tuffpest Residual Insecticide

Active constituent/s: 250 g/kg permethrin 25:75

Applicant name: Freezone Public Health Pty Ltd


Summary of use For the control of a range of insect pests





Product name: Tomcat Bait Packs

Active constituent/s: 0.05 g/kg bromadiolone

Applicant name: Scotts Australia Pty Ltd


Summary of use For control of rats and mice





Product name: Raid Max Ant Killer Indoor & Outdoor Surface Spray

Active constituent/s: 2.0 g/kg cypermethrin, 0.7 g/kg imiprothrin

Applicant name: S.C. Johnson & Son Pty Ltd


Summary of use For the control of cockroaches, ants, spiders, silverfish, fleas, clothes moths, carpet beetles and millipedes in household situations





Product name: Titan Imazamox 700 WG Herbicide

Active constituent/s: 700 g/kg imazamox

Applicant name: Titan Ag Pty Ltd


Summary of use For post-emergence control of certain annual grass and broadleaf weeds

in field peas, legume based pastures, Lucerne, peanuts and soybeans




4. VARIATIONS OF REGISTRATION

Application no: 105634

Product name: Talon Rat & Mouse Killer Ezy Throw Pellets


Applicant name: Syngenta Australia Pty Ltd


Summary of variation: To change product name from ‘TALON RAT & MOUSE KILLER EZY THROW’ to ‘TALON RAT & MOUSE KILLER EZY THROW PELLETS’ and to make minor label amendments

Date of variation: 12 April 2016






Product name: Talon Rat & Mouse Killer Pellets


Applicant name: Syngenta Australia Pty Ltd


Summary of variation: To change the product name from ‘TALON RODENTICIDE PELLETS’ to ‘TALON RAT & MOUSE KILLER PELLETS’ and make minor label amendments





Product name: Farmalinx Flufol 500 SC Fungicide

Active constituent/s: 500 g/L flutriafol

Applicant name: Farmalinx Pty Ltd


Summary of variation: To add a pack size range



Label approval no.: 65535100949


Product name: Couraze 200 Insecticide

Active constituent/s: 200 g/L imidacloprid

Applicant name: Cheminova Australia Pty Limited


Summary of variation: To change the product name from ‘CHEMINOVA COURAZE 200 SC INSECTICIDE’ to ‘COURAZE 200 INSECTICIDE’





Product name: Surefire Termiticide and Insecticide

Active constituent/s: 100 g/L fipronil

Applicant name: PCT Holdings Pty Ltd


Summary of variation: To extend label claims to include control of ants in urban situations





Product name: Impede Insecticide

Active constituent/s: 1 g/kg fipronil

Applicant name: BASF Australia Ltd


Summary of variation: To extend the use for funnel ants to include a general claim for nesting ants and to include spot treatments for control of nesting ants, nuisance ants, cockroaches and earwigs

Date of registration/approval:

Product registration no.:

20 April 2016

57764





Product name: Ecopar Herbicide

Active constituent/s: 20 g/L pyraflufen-ethyl

Applicant name: Sipcam Pacific Australia Pty Ltd


Summary of use To increase the maximum application rate in cereals and pasture and to extend the application window in cereals





Product name: Farmalinx Stuka Flexi Herbicide

Active constituent/s: 240 g/L picloram present as the potassium salt

Applicant name: Farmalinx Pty Ltd


Summary of use To extend the claims for use in various crops and for the control of a range of environmental and noxious woody and herbaceous weeds





Product name: Kenso Agcare Radicle 600 FS Flowable Seed Dressing

Active constituent/s: 600 g/L imidacloprid

Applicant name: Kenso Corporation (M) Sdn. Bhd

Applicant ACN: N/A

Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘KENSO AGCARE SAVAGE 600 FLOWABLE SEED DRESSING INSECTICIDE’ to ‘KENSO AGCARE RADICLE 600 FS FLOWABLE SEED DRESSING’

Date of variation: 23 March 2016

Product no.: 62062



Product name: Tricup 500 EC Herbicide

Active constituent/s: 500 g/L tri-allate


Applicant ACN: N/A

Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘ROTAM TRIALLATE 500 EC HERBICIDE’ to ‘TRICUP 500 EC HERBICIDE’


Product no.: 81147





Product name: Nadal Extra Herbicide

Active constituent/s: 300 g/L triclopyr present as the butoxyethyl ester, 100 g/L picloram present as hexyloxypropylamine salt


Applicant ACN: N/A

Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘ROTAM PICLORAM + TRICLOPYR (100 + 300) HERBICIDE’ to ‘NADAL EXTRA HERBICIDE’


Product no.: 81179



Product name: Macro Protect Massacre 450 Herbicide

Active constituent/s: 450 g/L glyphosate present as the isopropylamine salt

Applicant name: Macrofertil Australia Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RAVENSDOWN MASSACRE 450 HERBICIDE’ to ‘MACRO PROTECT MASSACRE 450 HERBICIDE’


Product no.: 47335



Product name: Macro Protect Clodinafop Herbicide

Active constituent/s: 240 g/L clodinafop-propargyl 60 g/L cloquintocet-mexyl

Applicant name: Macrofertil Australia Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RAVENSDOWN OAT-X HERBICIDE’ to ‘MACRO PROTECT CLODINAFOP HERBICIDE’


Product no.: 66092


5. LABEL APPROVAL


Product name: Orthene Xtra Insecticide

Active constituent/s: 970 g/kg acephate

Applicant name: Arysta Lifescience North America LLC

Applicant ACN: N/A

Summary of use: To add an additional label name to the product under ‘ARYSTA MATAK XTRA INSECTICIDE’

Date of approval: 15 April 2016





Product name: Arysta Select Xtra Herbicide

Active constituent/s: 360 g/L clethodim

Applicant name: Arysta Lifescience North America LLC

Applicant ACN: N/A

Summary of use: To add an additional label name to the product under ‘ARYSTA CENTURION XTRA HERBICIDE’




Product name: Trithor Termite Protection

Active constituent/s: 2 g/kg deltamethrin

Applicant name: Ensystex Australia Pty Ltd


Summary of use: To add an additional label name to the product under ‘TRITHOR ECOGUARD TERMITE PROTECTION’




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: Exelpet Intestinal All-Wormer Tablets for Dogs

Active constituent/s: Each tablet contains 542 mg/Tb oxantel embonate, 143 mg pyrantel embonate and 50 mg praziquantel

Applicant name: Exelpet Products A Div Of Mars Australia Pty Ltd


Summary of use For the control of roundworm, hookworm, whipworm and tapeworm in dogs. Also controls hydatid tapeworm

Date of registration/approval: 30 March 2016




Product name: Equistar Elite Horse Worming Paste

Active constituent/s: Each gram of paste contains: 167 mg morantel tartrate and 4 mg abamectin

Applicant name: The Hunter River Company Pty Limited


Summary of use For use in the treatment and control of tapeworms, roundworms, bots and skin lesions in horses





Product name: Advantage Seresto Flea collar for Kittens and Cats (8 months Flea Protection)

Active constituent/s: 100 mg/g imidacloprid, 45 mg/g flumethrin

Applicant name: Bayer Australia Ltd (Animal Health)


Summary of use For the treatment and prevention of flea infestations for up to 8 months





Product name: Purina Total Care Flea Control For Cats


Applicant name: Nestle Purina Petcare A Div of Nestle Australia LTD


Summary of use For use in the treatment and prevention of flea infestations, control of flea allergy dermatitis,

and biting lice on cats







Product name: Deccox Medicated Premix

Active constituent/s: 60 g/kg Decoquinate

Applicant name: Zoetis Australia Pty Ltd


Summary of use For use in the treatment and prevention of coccidiosis in broiler chickens





Product name: Purina Total Care Flea and Tick Control For Large Dogs


Applicant name: Nestle Purina Petcare A Div of Nestle Australia LTD


Summary of use For use in the treatment and prevention of flea infestations, control of flea allergy dermatitis,

control of ticks and biting lice on large dogs





Product name: Equistar Contest Oral Paste For Horses

Active constituent/s: Each gram of paste contains: 140 mg praziquantel and 18.7 mg ivermectin

Applicant name: The Hunter River Company Pty Limited


Summary of use For use in the treatment and control of tapeworms, roundworms, bots, and skin lesions in horses




2. VARIATIONS OF REGISTRATION


Product name: Advantage Seresto Tick and Flea Collar for Dogs over 8 kg (4 Months Tick Protection/ 8 Months Flea Protection)




Summary of variation: To change the product name from ‘BAY-O-PET TICK COLLAR FOR DOGS OVER 8 KG’ to ‘ADVANTAGE SERESTO TICK AND FLEA COLLAR FOR DOGS OVER 8 KG (4 MONTHS TICK PROTECTION/ 8 MONTHS FLEA PROTECTION)’ and extend the claims to the treatment and prevention of flea infestations for up to 8 months







Product name: Advantage Seresto Tick and Flea Collar for Dogs and Puppies up to 8 kg (4 Months Tick Protection / 8 Months Flea Protection)




Summary of variation: To change the product name from ‘BAY-O-PET TICK COLLAR FOR DOGS AND PUPPIES LESS THAN 8 KG’ to ‘ADVANTAGE SERESTO TICK AND FLEA COLLAR FOR DOGS AND PUPPIES UP TO 8 KG (4 MONTHS TICK PROTECTION/ 8 MONTHS FLEA PROTECTION)’, and to extend shelf life and claims to the treatment and prevention of flea infestations for up to 8 months




3. VARIATION OF LABEL APPROVAL


Product name: Relsure PCV

Active constituent/s: RP >=1.0 inactivated porcine circovirus type 1–type 2 chimera

Applicant name: Zoetis Australia Pty Ltd


Summary of variation: To add an additional dosing to inject 2 x 1 mL doses intramuscularly into pigs 3 weeks of age or older at a 3 week interval




Approved Active Constituent

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: Propineb

Applicant name: Sinon Australia Pty Limited


Summary of use: For use in agricultural chemical products


Approval no.: 81394


Active constituent/s: Hexazinone

Applicant name: Zhejiang Yingxin Chemical Co. Ltd

Applicant ACN: N/A



Approval no.: 81698


Active constituent/s: Atrazine

Applicant name: Shandong Kesai Eagrow Co Ltd

Applicant ACN: N/A



Approval no.: 81685


Active constituent/s: Glufosinate-ammonium

Applicant name: Hebei Bestar Commerce and Trade Co., Ltd

Applicant ACN: N/A



Approval no.: 81694


Active constituent/s: Indoxacarb

Applicant name: Zhejiang Yingxin Chemical Co. Ltd

Applicant ACN: N/A



Approval no.: 81715


Approved Active Constituent


Active constituent/s: Trifluralin

Applicant name: Shandong Binnong Technology Co., Ltd

Applicant ACN: N/A



Approval no.: 81751


Active constituent/s: Rabbit Haemorrhagic Disease Virus, 08q712 Strain

Applicant name: NSW Department Of Primary Industries

Applicant ACN: N/A



Approval no.: 82012


Active constituent/s: Chlorpyrifos

Applicant name: Sanonda (Australia) Pty Ltd




Approval no.: 81656


Active constituent/s: cloquintocet-mexyl

Applicant name: Grow Choice Pty Limited




Approval no.: 81717


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 2016 (No. 5).

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 Schedule 20 in the Australia New Zealand Food Standards Code


In the previous notice, the APVMA gazetted 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 2016

(No. 5)) to MRLs into Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code.

MRLs contained in Schedule 20 provide the limits for residues of agricultural and veterinary chemicals that may

legitimately occur in foods. By this means, Schedule 20 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 Schedule 20 in the APVMA Gazette. The variations will take

effect as from the date of that subsequent notice.



PROPOSED AMENDMENT (AGRICULTURAL AND VETERINARY CHEMICALS CODE INSTRUMENT NO. 4 (MRL

STANDARD) AMENDMENT INSTRUMENT 2016 (NO. 5))

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

[1] The table to section S20–3 in Schedule 20 is varied by

[1.1] omitting from each of the following chemicals, the foods and associated MRLs

Agvet chemical: Flamprop-methyl

Permitted residue: Flamprop-methyl

Lupin (dry) 0.05

[1.2] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order

Agvet chemical: Azoxystrobin

Permitted residue: Azoxystrobin

Egg plant T2

Okra T2

Sweet corn (kernels) T0.05

Agvet chemical: Chloridazon

Permitted residue: Chloridazon

Beetroot leaves 1

Chard (silver beet) 1

Spinach 1

Agvet chemical: Fluensulfone

Permitted residue: Sum of fluensulfone, 3,4,4-trifluorobut-3-ene-1-sulfonic acid (M-3627) and 5-chloro-thiazole-2-sulfonic acid (M-3625)

Sweet potato T1

Agvet chemical: Mandipropamid

Permitted residue: Mandipropamid

Mizuna 30

Agvet chemical: Meloxicam

Permitted residue: Meloxicam

Sheep fat 0.01

Sheep kidney 0.01

Sheep liver 0.01

Sheep meat 0.01



[1.3] omitting for each of the following chemicals, the maximum residue limit for the food and substituting

Agvet chemical: Mandipropamid

Permitted residue: Mandipropamid

Leafy vegetables 30



INVITATION FOR SUBMISSIONS

Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the

proposal to vary Schedule 20–Maximum residue limits in 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

Schedule 20’ and quote the correct amendment number.

DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (AEST) 31 May 2016

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


mailto:[email protected]


Variations to Schedule 20 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 Schedule 20–Maximum Residue Limits of the Australia New Zealand Food

Standards Code. This notice pertains to proposals (No. 2) gazetted on 9 February 2016 (No. APVMA 3).

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 Schedule 20. A copy of the Amendment Instrument

(No. APVMA 4, 2016) accompanies this notice. For a complete and up-to-date version of Schedule 20, 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 Schedule 20 provide the limits for residues of agricultural and

veterinary chemicals that may legitimately occur in foods. By this means, Schedule 20 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.


MRL 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—Schedule 20–Maximum residue limits Variation

Instrument No. APVMA 4, 2016

I, Matthew O’Mullane, Acting 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.

Matthew O’Mullane

Delegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines

Authority

Dated this Twenty Eighth day of April 2016



Part 1 Preliminary

1 Name of instrument

This instrument is the Australia New Zealand Food Standards Code—Schedule 20Maximum residue limits Variation Instrument No. APVMA 4, 2016.

2 Commencement

In accordance with subsection 82(8) of the Food Standards Australia New Zealand Act 1991, this instrument commences on the day 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 9 of 3 May 2016.

3 Object

The object of this instrument is for the APVMA to make variations to Schedule 20Maximum residue limits in 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 Schedule 20Maximum residue limits in the Australia New Zealand Food Standard Code as defined in Section 4 of 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. Schedule 20 was published in the Food Standards Gazette FSC 96 on Thursday 10 April 2015 and was registered as a legislative instrument on 1 April 2015 (F2015L00468).

Part 2 Variations to Schedule 20—Maximum Residue

Limits

5 Variations to Schedule 20

The Schedule to this instrument sets out the variations made to the Principal Instrument by this instrument.



Schedule

Variations to Schedule 20–Maximum residue limits

[1] The table to section S20—3 in Schedule 20 is varied by

[1.1] inserting in alphabetical order

Agvet chemical: Decoquinate Permitted residue: Decoquinate

Chicken kidney 0.8

Chicken liver 1

Chicken meat 0.5

Chicken fat/skin 1

[1.2] omitting from each of the following chemicals, the foods and associated MRLs

Agvet chemical: Bifenthrin Permitted residue: Bifenthrin

Brassica (cole or cabbage) vegetables, head cabbages, flowerhead brassicas [except cabbages, head]

T1

Cabbages, head T7

Agvet chemical: Maldison Permitted residue: Maldison

Egg plant 0.5

Fruit [except citrus fruits; currant, black; dried fruits; grapes; pear; strawberry]

2

Pear 0.5

Peppers, sweet 0.5

Tomato 3

Vegetables [except beans (dry); cauliflower; chard (silver beet); egg plant; garden pea; kale; kohlrabi; lentil (dry); onion, Welsh; peppers, sweet; root and tuber vegetables; shallot; spring onion; tomato; turnip, garden]

2

[1.3] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order

Agvet chemical: Bifenthrin Permitted residue: Bifenthrin

Brassica (cole or cabbage) vegetables, head cabbages, flowerhead brassicas

T1

Celery T*0.01

Agvet chemical: Cyproconazole Permitted residue: Cyproconazole, sum of isomers

Maize T*0.01

Agvet chemical: Difenoconazole Permitted residue: Difenoconazole

Cotton seed T0.05



Agvet chemical: Ethephon Permitted residue: Ethephon

Lychee T*0.05

Agvet chemical: Etoxazole Permitted residue: Etoxazole

Mango T0.1

Agvet chemical: Maldison Permitted residue: Maldison

Berries and other small fruits [except grapes; strawberry]

10

Cucumber 3

Fruiting vegetables, other than cucurbits

3

Fruits [except berries and other small fruits; citrus fruits; dried fruits; stone fruits]

2

Stone fruits 5

Vegetables [except beans (dry); cauliflower; chard; cucumber; fruiting vegetables, other than cucurbits; garden pea; kale; kohlrabi; lentil (dry); onion, Welsh; root and tuber vegetables; shallot; spring onion; turnip, garden]

2

Agvet chemical: Spinetoram Permitted residue: Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L

Cotton seed *0.01

Pulses 0.01



[1.4] omitting for each of the following chemicals, the maximum residue limit for the food and substituting

Agvet chemical: Azoxystrobin Permitted residue: Azoxystrobin

Cotton seed T0.05

Agvet chemical: Spinetoram Permitted residue: Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L

Milk fats 0.2

Milks 0.01


Cancellation of Registration at the Request of the Holder


At the request of the holder, the APVMA has cancelled the registration and the associated label approvals of the following product:

Product no. Product name Approval holder Date of effect

37556 ENZYPLEX ENZYME COMPLEX FOR

DOGS

CEVA ANIMAL HEALTH PTY LTD 19 April 2016

The following instructions set out how a person can deal with the cancelled product.

SUPPLY

A person may supply or cause to be supplied product manufactured prior to 19 April 2016 at wholesale and retail level,

until the 19 April 2017.

After 19 April 2017 it will be an offence against the Agvet Codes to have possession or custody of the product with the

intention to supply, or to supply the product.

USE

A person may continue to use the product according to its label instructions until 19 April 2017.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product in accordance with the

above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of,

use or otherwise deal with the product after the registration has been cancelled until 19 April 2017.

The supply and use of the product must be in accordance with the conditions of registration or approval, including any

conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the product listed in the table in a manner that contravenes

the above instructions.

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Chemical Review


PO Box 6182

SYMONSTON ACT 2609

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776





Cancellation of Label Approval at the Request of the Holder

At the request of the Holder, the APVMA has cancelled the following label approval:

Product no. Product name Approval holder Cancelled label approvals Date of effect

62394 ABBEY TIAMULIN

PREMIX

ABBEY LABORATORIES

PTY LTD

62394/47876 19 April 2016

The following instructions set out how a person can deal with product bearing a cancelled label.

SUPPLY

A person may supply or cause to be supplied product bearing a cancelled label manufactured prior to 19 April 2016 at

wholesale and retail level, until 19 April 2017.

After 19 April 2017 it will be an offence against the Agvet Codes to have possession or custody of the product bearing a

cancelled label with the intention to supply, or to supply the product bearing a cancelled label.

USE

A person may continue to use the product bearing a cancelled label according to its label instructions until 19 April 2017.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product bearing a cancelled label in

accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess,

have custody of, use or otherwise deal with the product bearing a cancelled label after the approval has been cancelled

until 19 April 2017.

The supply and use of the product bearing a cancelled label must be in accordance with the conditions of registration or

approval, including any conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the product bearing a cancelled label listed in the table in a

manner that contravenes the above instructions.

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Chemical Review


PO Box 6182

SYMONSTON ACT 2609

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776


Documents

APVMA Gazette No. 9, 3 May 2016 · 2016. 5. 3. · No. APVMA 9, Tuesday, 3 May 2016 Published by The Australian Pesticides and Veterinary Medicines Authority AGRICULTURAL AND VETERINARY