apvma gazette no. 11, 31 may 2016

No. APVMA 11, Tuesday, 31 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 11, Tuesday, 31 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 activity in

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

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www.apvma.gov.au/news-and-publications/publications/gazette

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For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.

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http://www.apvma.gov.au/news-and-publications/publications/gazette


CONTENTS

Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and Approved Labels .................................................................................................... 11 Approved Active Constituents ....................................................................................................................................... 13 New Active Constituent Pyriofenone ............................................................................................................................. 14 New Active Constituent Momfluorothrin ........................................................................................................................ 16 Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations ............................... 18 Cancellation of Registration at the Request of the Holder ............................................................................................. 22 Cancellation of Label Approval at the Request of the Holder ........................................................................................ 23 Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code ................................................. 25 Variations to Schedule 20 of the Australia New Zealand Food Standards Code ........................................................... 29

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 3, Tuesday, 9 February 2016.

In the Notice, the product name ‘Dobabait PAPP Wild Dog Bait’ was incorrect.

The correct entry for the Notice of Registration for ‘Dogabait PAPP Wild Dog Bait’ is on page 4 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.: 50136 Product name: Dogabait PAPP Wild Dog Bait Active constituent/s: 16.8 g/kg para-aminopropiophenone (PAPP). Each 60 g bait contains 1000 mg para-

aminopropiophenone (PAPP) Applicant name: Animal Control Technologies (Australia) Pty Ltd Applicant ACN: 137 868 449 Summary of use For the reduction in wild dog numbers Date of registration/approval: 22 January 2016 Product registration no.: 65094 Label approval no.: 65094/50136

2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Application no.: 104770 Product name: Relyon Mantra 750WG Fungicide Active constituent/s: 750 g/kg mancozeb Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For the control of certain fungus diseases of fruit, field crops, tobacco, turf, vegetables and

ornamentals Date of registration/approval: 11 May 2016 Product registration no.: 81991 Label approval no.: 81991/104770

Application no.: 100311 Product name: Impala Fungicide Active constituent/s: 96 g/L azoxystyrobin and 194 g/L triticonazole Applicant name: Turf Culture Pty Ltd Applicant ACN: 117 986 615 Summary of use For broad spectrum control of fungal diseases in turf Date of registration/approval: 12 May 2016 Product registration no.: 80146 Label approval no.: 80146/100311



Application no.: 105638 Product name: Relyon Mueso Stick 720 Fungicide Active constituent/s: 720 g/L chlorothalonil Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For the control of fungal diseases on almonds, bananas, cucurbits, grapes,

ornamentals, peanuts, stone fruit, tobacco and vegetables Date of registration/approval: 12 May 2016 Product registration no.: 82389 Label approval no.: 82389/105638

Application no.: 101811 Product name: Genfarm Isoxaflutole 750 WG Herbicide Active constituent/s: 750 g/kg isoxaflutole Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use For the control and suppression of various broadleaf weeds and grasses in

sugarcane and chickpeas Date of registration/approval: 13 May 2016 Product registration no.: 80855 Label approval no.: 80855/101811

Application no.: 106116 Product name: Confiprem 200SC Termiticide Active constituent/s: 200 g/ imidacloprid Applicant name: Premier Shukuroglou AU Pty Ltd Applicant ACN: N/A Summary of use For use in the management of subterranean and drywood termites Date of registration/approval: 16 May 2016 Product registration no.: 82574 Label approval no.: 82574/106116

Application no.: 101126 Product name: Tizca Fungicide Active constituent/s: 500 g/L fluazinam Applicant name: FMC Australasia Pty Ltd Applicant ACN: 095326891 Summary of use For the control of club root of broccoli, brussels sprouts, cabbage, cauliflower and

kohlrabi: the pre-bud burst suppression of phomopsis cane and leaf blight in grape vines and the control of white root rot in apples

Date of registration/approval: 13 May 2016 Product registration no.: 80568 Label approval no.: 80568/101126



Application no.: 104778 Product name: CGS Dropp Liquid Cotton Defoliant Active constituent/s: 500 g/L thidiazuron Applicant name: Cotton Growers Services Pty Ltd Applicant ACN: 001 723 048 Summary of use For the defoliation of cotton prior to harvest Date of registration/approval: 16 May 2016 Product registration no.: 81998 Label approval no.: 81998/104778

Application no.: 102445 Product name: Surefire Macromite Miticide Active constituent/s: 480 g/L bifenazate Applicant name: PCT Holdings Pty Ltd Applicant ACN: 099 023 962 Summary of use For the control of mites in pome and stone fruit Date of registration/approval: 17 May 2016 Product registration no.: 81158 Label approval no.: 81158/102445

Application no.: 105908 Product name: Eureka! Bromoxynil-MCPA Herbicide Active constituent/s: 200 g/L bromoxynil present as the octanoate 200 g/L MCPA present as the ethyl

hexyl ester Applicant name: Eureka! Agresearch Pty Ltd Applicant ACN: 086 194 738 Summary of use For the control of weeds in wheat, oats, barley, cereal rye, triticale, linseed, grass

pastures and turf Date of registration/approval: 17 May 2016 Product registration no.: 82500 Label approval no.: 82500/105908

Application no.: 37055 Product name: Antracol 700 Wg Fungicide Active constituent/s: 700 g/kg propineb Applicant name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of use For the control of certain diseases of cucurbits, onions, potatoes, and tomatoes as

well as black spot and citrus mite of citrus Date of registration/approval: 19 May 2016 Product registration no.: 59925 Label approval no.: 59925/37055



Application no.: 105479 Product name: Relyon Clethora 240EC Herbicide Active constituent/s: 240 g/L clethodim Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas,

cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, lettuce, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans

Date of registration/approval: 19 May 2016 Product registration no.: 82344 Label approval no.: 82344/105479

3. VARIATIONS OF REGISTRATION

Application no: 106315 Product name: Rometri 750 WG Herbicide Active constituent/s: 750 g/kg metribuzin Applicant name: Rotam Agrochemical Co., Ltd Applicant ACN: N/A Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘REMETRI 750 WG HERBICIDE’ to ‘ROMETRI 750 WG HERBICIDE’ Date of variation: 13 April 2016 Product registration no.: 82085 Label approval no.: 82085/106315

Application no: 106330 Product name: Maxi Block SPF 30+ Sunscreen With Insect Repellent Very High Protection For Sun

Sensitive Skin 2 Hours Water Resistant Broad Spectrum Active constituent/s: 20 mg/g octylbicycloheptenedicarboximide, 15 mg/g di-n-propyl isocinchomeronate,

40 mg/g diethyl toluamide Applicant name: Baxter Laboratories Pty Ltd Applicant ACN: 093 625 435 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘SUN SAVE SPF 30+ SUNSCREEN WITH INSECT REPELLENT VERY HIGH PROTECTION FOR SUN SENSITIVE SKIN 2 HOURS WATER RESISTANT BROAD SPECTRUM PABA FREE’ to ‘MAXI BLOCK SPF 30+ SUNSCREEN WITH INSECT REPELLENT VERY HIGH PROTECTION FOR SUN SENSITIVE SKIN 2 HOURS WATER RESISTANT BROAD SPECTRUM’

Date of variation: 15 April 2016 Product registration no.: 59863 Label approval no.: 59863/106330

Application no: 105486 Product name: Genfarm Clethodim 360 Selective Herbicide Active constituent/s: 360 g/L clethodim Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of variation: To correct the use rates Date of variation: 11 May 2016 Product registration no.: 81849 Label approval no.: 81849/105486



Application no: 102822 Product name: Wildebeest 700 Herbicide Active constituent/s: 700 g/kg glyphosate present as the mono-ammonium salt Applicant name: Crop Culture Pty Ltd Applicant ACN: 142 860 473 Summary of variation: To change the product name ‘CROP CULTURE WILDEBEEST 700 HERBICIDE’ to

‘WILDEBEEST 700 HERBICIDE’, amend the pack size range and to add uses from reference products

Date of variation: 12 May 2016 Product registration no.: 68797 Label approval no.: 68797/102822

Application no: 101328 Product name: Nufarm Digger Fungicide Active constituent/s: 250 g/L difenoconazole Applicant name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of variation: To add a new major crop- grapevines (except wine grapes) and two minor crops (celery and

beetroot) Date of variation: 12 May 2016 Product registration no.: 65130 Label approval no.: 65130/101328

Application no: 101374 Product name: Cavalry Weatherguard Fungicide Active constituent/s: 720 g/L chlorothalonil Applicant name: Adama Australia Pty Limited Applicant ACN: 050 328 973 Summary of variation: To extend use into chickpeas and lentils Date of variation: 13 May 2016 Product registration no.: 59986 Label approval no.: 59986/101374

Application no.: 104936 Product name: Komondor 200 Insecticide Active constituent/s: 200 g/L imidacloprid Applicant name: Crop Culture Pty Ltd Applicant ACN: 142 860 473 Summary of variation: To extend the uses to include soil applied treatment for the control of greyback and childers

canegrub in sugarcane and silverleaf whitefly in various vegetable crops Date of variation: 13 May 2016 Label approval no.: 67913/104936

Application no: 104419 Product name: Uniform Fungicide Active constituent/s: 124 g/L metalaxyl-m 322 g/L azoxystrobin Applicant name: Syngenta Australia Pty Ltd Applicant ACN: 002 933 717 Summary of variation: To extend control of leaf rust in barley and suppression of net blotch and powdery mildew in

barley and modify label instructions for mixing with liquid fertilizer Date of variation: 16 May 2016 Product registration no.: 69673 Label approval no.: 69673/104419



Application no: 105686 Product name: Yates Zero Weedkiller 490 g/L Super Concentrate Active constituent/s: 490 g/L glyphosate as isopropylamine salt Applicant name: DULUXGROUP (AUSTRALIA) PTY LTD Applicant ACN: 000 049 427 Summary of variation: To update the pack size range Date of variation: 18 May 2016 Product registration no.: 58024 Label approval no.: 58024/105686

Application no: 105637 Product name: Talon Rat & Mouse Killer Pellet Trays Active constituent/s: 0.05 g/kg brodifacoum Applicant name: Syngenta Australia Pty Ltd Applicant ACN: 002 933 717 Summary of variation: To change the product name from ‘TALON RAT & MOUSE KILLER’ to ‘TALON RAT &

MOUSE KILLER PELLET TRAYS’ Date of variation: 18 May 2016 Product registration no.: 58338 Label approval no.: 58338/105637

Application no: 105625 Product name: Spalding Glufosinate 200 Herbicide Active constituent/s: 200 g/L glufosinate-ammonium Applicant name: Spalding Holdings Pty. Ltd. Applicant ACN: 010 155 852 Summary of variation: To add an additional pack size Date of variation: 19 May 2016 Product registration no.: 70193 Label approval no.: 70193/105625

Application no: 101239 Product name: Success Neo Insecticide Active constituent/s: 120 g/L spinetoram Applicant name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of variation: To amend the WHP statements with regard to forage brassica, to add an export animal feed

interval (EAFI) and to extend use into pulses and cotton Date of variation: 20 May 2016 Product registration no.: 64109 Label approval no.: 64109/101239

Application no: 103521 Product name: Farmalinx Oxafert Herbicide And Fertiliser Active constituent/s: 10 g/kg oxadiazon Applicant name: Farmalinx Pty Ltd Applicant ACN: 134 353 245 Summary of variation: To extend the use for control of various weeds in woody ornamental shrubs, trees and vines

in nurseries and field grown ornamental crops Date of variation: 23 May 2016 Product registration no.: 70376 Label approval no.: 70376/103521



Application no.: 106081 Product name: Tricup 500 EC Herbicide Active constituent/s: 500 g/L tri-allate

Applicant name: Rotam Agrochemical Co., Ltd

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’ Date of variation: 29 March 2016 Product registration no.: 81147

Label approval no.: 81147/106081

4. LABEL APPROVAL

Application no.: 105542 Product name: Pool Pro Tropix Algaecide Active constituent/s: 40 g/L copper (cu) present as cupric ammonium complex Applicant name: The Pops Group Pty Ltd Applicant ACN: 095 828 461 Summary of use: To add an additional label name to the product under ‘POOLWARE TROPIX ALGAECIDE’ Date of approval: 15 May 2016 Label approval no.: 67418/105542

Application no.: 105851 Product name: Hymenopthor Ultra Granular Ant and Cockroach Bait Active constituent/s: 0.1 g/kg fipronil Applicant name: Ensystex Australasia Pty Ltd Applicant ACN: 102 221 965 Summary of use: To add an additional label name to the product under ‘PROTECT-US INVADER MAX ANT

& COCKROACH GRANULAR BAIT’ Date of approval: 18 May 2016 Label approval no.: 65833/105851



Veterinary Chemical Products and Approved Labels

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Application no.: 62284 Product name: ENGAIN 20 Ractopamine Hydrochloride Premix Active constituent/s: 20 g/kg ractopamine hydrochloride Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use For increased carcass leanness and increased dressing percentage in finisher pigs Date of registration/approval: 18 May 2016 Product registration no.: 70005 Label approval no.: 70005/62284

Application no.: 62285 Product name: ENGAIN 100 Ractopamine Hydrochloride Premix Active constituent/s: 20 g/kg ractopamine hydrochloride Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use For increased carcass leanness and increased dressing percentage in finisher pigs Date of registration/approval: 18 May 2016 Product registration no.: 70006 Label approval no.: 70006/62285

2. VARIATIONS OF REGISTRATION

Application no: 106421 Product name: Advantage Seresto For Dogs Over 8 Kg Fleas & Ticks Collar Active constituent/s: 100 mg/g imidacloprid, 45 mg/g flumethrin Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘ADVANTAGE SERESTO TICK AND FLEA COLLAR FOR DOGS OVER 8 KG (4 MONTHS TICK PROTECTION/ 8 MONTHS FLEA PROTECTION)’ to ‘ADVANTAGE SERESTO FOR DOGS OVER 8 KG FLEAS & TICKS COLLAR’




Application no: 106422 Product name: Advantage Seresto For Dogs And Puppies Up To 8 Kg Fleas & Ticks Collar Active constituent/s: 100 mg/g imidacloprid, 45 mg/g flumethrin Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘ADVANTAGE SERESTO TICK AND FLEA COLLAR FOR DOGS OVER 8 KG (4 MONTHS TICK PROTECTION/ 8 MONTHS FLEA PROTECTION)’ to ‘ADVANTAGE SERESTO FOR DOGS OVER 8 KG FLEAS & TICKS COLLAR’


Application no: 106453 Product name: Advantage Seresto For Kittens And Cats Fleas Collar Active constituent/s: 100 mg/g imidacloprid, 45 mg/g flumethrin Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘ADVANTAGE SERESTO FLEA COLLAR FOR KITTENS AND CATS (8 MONTHS FLEA PROTECTION)’ to ‘ADVANTAGE SERESTO FOR KITTENS AND CATS FLEAS COLLAR’


Application no.: 105049 Product name: Equivac HEV Hendra Virus Vaccine for Horses Active constituent/s: 100 μg/mL g-protein (sg) of hendra virus, 0.1 mg/mL thiomersal Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of variation: To amend the dosing schedule to allow ongoing annual booster doses Date of variation: 13 May 2016 Product registration no.: 68996 Label approval no.: 68996/105049

3. VARIATION OF LABEL APPROVAL

Application no.: 102836 Product name: Proheart SR-12 Injection Once-A-Year Heartworm Preventative for Dogs Active constituent/s: 100 mg/g moxidectin Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of variation: To include advice for concurrent treatment with revolution (selamectin) Date of variation: 13 May 2016 Label approval no.: 51805/102836



Approved Active Constituents

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of the approval of the following active constituents, with effect from the dates shown.

1. ACTIVE CONSITUTENT

Application no.: 103167 Active constituent/s: Prohexadione-calcium Applicant name: Fine Agrochemicals Limited Applicant ACN: N/A Summary of use: For use in agricultural chemical products Date of approval: 17 May 2016 Approval no.: 81468

Application no.: 102380 Active constituent/s: Mecoprop Applicant name: Ciech Sarzyna Spolka Akcyjna Applicant ACN: N/A Summary of use: For use in agricultural chemical products Date of approval: 17 May 2016 Approval no.: 81122

Application no.: 104089 Active constituent/s: Carfentrazone-ethyl Applicant name: Agroshine Australia Pty Ltd. Applicant ACN: 105 873 023 Summary of use: For use in agricultural chemical products Date of approval: 18 May 2016 Approval no.: 81809

Approved Active Constituents


New Active Constituent Pyriofenone

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new active constituent, pyriofenone.

Common Name: Pyriofenone

IUPAC Name: 5-chloro-2-methoxy-4-methylpyridin-3-yl 2,3,4-trimethoxy-6-methylphenyl ketone

CAS Name: (5-chloro-2-methoxy-4-methyl-3-pyridinyl)(2,3,4-trimethoxy-6-methylphenyl)methanone

CAS Registry Number: 688046-61-9

Manufacturer’s Code: IKF-309

Minimum Purity: 965 g/kg

Molecular Formula: C18H20ClNO5

Molecular Weight: 539.52

Structure:

Chemical Family: aryl phenyl ketone

Mode of Action: Fungicide

SUMMARY OF THE APVMA’S EVALUATION OF PYRIOFENONE ACTIVE CONSTITUENT

The Scientific Assessment and Chemical Review Program of the APVMA has evaluated the chemistry aspects of pyriofenone active constituent (manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.

On the basis of the data provided, and the toxicological assessment, it is proposed that the following APVMA Active Constituent Standard be established for pyriofenone active constituent:

Constituent Specification Level

Pyriofenone Pyriofenone Not less than 965 g/kg

Compounds of toxicological significance are not expected to occur in Pyriofenone TGAC as a result of the raw materials and the synthetic route used.

The Office of Chemical Safety has considered the toxicological aspects of pyriofenone TGAC, and advised that there are no toxicological objections to the approval of this chemical.

An Acceptable Daily Intake (ADI) of 0.09 mg/kg bw/d has been set, based on a No-Observed Effect Level (NOEL) of 9 mg/kg bw/d in both a 1 and 2–year dietary study, after applying a 100 fold safety factor (consisting of a 10–fold safety factor for both intra- and inter-species variation).



An Acute Reference Dose (ARfD) was not established and is not necessary, based on the low acute toxicity profile of pyriofenone and the results of available repeat dose toxicity, genotoxicity and reproductive/developmental studies that indicate pyriofenone is unlikely to present an acute hazard to humans after single dose administration.

Based on the toxicity profile, it was recommended to the Chemicals Scheduling Delegate (the Delegate) of the Secretary of the Department of Health that consideration be given to including pyriofenone in Schedule 6 of the Poisons Standard with no cut offs.

The Advisory Committee on Chemicals Scheduling (ACCS) considered pyriofenone to be appropriate for inclusion in Schedule 6 of the Poisons Standard at the meeting of 28 October 2014 with the implementation date of 1 February 2015.

The OCS has not specified toxicologically significant impurities for the technical grade active constituent.

The APVMA accepts the findings and recommendations of its advisers on these criteria.

The APVMA is satisfied that the proposed importation and use of pyriofenone would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use.

MAKING A SUBMISSION

In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for approval of pyriofenone should be granted. Submissions should relate only to matters that are considered in determining whether the safety criteria set out in section 5A of the Agvet Code have been met. Submissions should state the grounds on which they are based.

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.

When making a submission please include a:

• contact name • company or group name (if relevant) • email or postal address • date you made the submission.

All personal and confidential commercial information (CCI)1 material contained in submissions will be treated confidentially.

Written submissions should be addressed in writing to:

Chemistry and Manufacture Director Scientific Assessment and Chemical Review Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4701 Fax: +61 2 6210 4721 Email: [email protected]

1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.



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Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 16

New Active Constituent Momfluorothrin

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new active constituent, momfluorothrin for use as an insecticide.

Common Name: Momfluorothrin

IUPAC Name: 2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (EZ)-(1RS,3RS;1RS,3SR)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate

CAS Name: [2,3,5,6-tetrafluoro-4-(methoxymethyl)phenyl] methyl 3-(2-cyano-1-propen-1-yl)-2,2-dimethylcyclopropanecarboxylate

CAS Registry Number: 609346-29-4

Manufacturer’s Code: S-1563

Minimum Purity: 930 g/kg

Molecular Formula: C19H19F4NO3

Molecular Weight: 385.35

Structure:

Chemical Family: synthetic pyrethroid

Mode of Action: insecticide

SUMMARY OF THE APVMA’S EVALUATION OF MOMFLUOROTHRIN ACTIVE CONSTITUENT

The Scientific Assessment and Chemical Review Program of the APVMA has evaluated the chemistry aspects of momfluorothrin active constituent (manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.

On the basis of the data provided, and the toxicological assessment, it is proposed that the following APVMA Active Constituent Standard be established for momfluorothrin active constituent:

Constituent Specification Level

Momfluorothrin Momfluorothrin Not less than 930 g/kg, comprising of

2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (Z)-(1R,3R)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclo propanecarboxylate; RTZ isomer and

2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (E)-(1R,3R)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclo propanecarboxylate; RTE isomer

at an approximate ratio of 9:1 respectively.


Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 17

Compounds of toxicological significance are not expected to occur in momfluorothrin TGAC as a result of the raw materials and the synthetic route used.

The Office of Chemical Safety has considered the toxicological aspects of momfluorothrin TGAC, and advised that there are no toxicological objections to the approval of this active constituent.

An ADI and ARfD for momfluorothrin have not been set as momfluorothrin is not proposed for food-producing uses at this time.

Momfluorothrin was referred to the Delegate of the Secretary of the Department of Health for scheduling consideration. Subsequently, the Delegate referred the application to the Advisory Committee for Chemicals Scheduling (ACCS) for advice in August 2015. The ACCS recommended inclusion of momfluorothrin in Schedule 6. The reasons for the recommendation were that the toxicity of momfluorothrin was consistent with Schedule 6 factors.

On 19 November 2015 the Delegate to the Secretary of the Department of Health accepted the advice from the ACCS and published a final scheduling decision to create a new Schedule 6 listing of momfluorothrin in the Poisons Standard index of the SUSMP. The delegate confirmed the proposed implementation date of 1 February 2016.

The OCS has not specified any toxicologically significant impurities in technical grade momfluorothrin.

The APVMA accepts the findings and recommendations of its advisers on these criteria.

The APVMA is satisfied that the proposed importation and use of momfluorothrin would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use.

MAKING A SUBMISSION

In accordance with section 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for approval of momfluorothrin should be granted. Submissions should relate only to matters that are considered in determining whether the safety criteria set out in section 5A of the Agvet Code have been met. Submissions should state the grounds on which they are based.

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.

When making a submission please include a:

• contact name • company or group name (if relevant) • email or postal address • date you made the submission.

All personal and confidential commercial information (CCI)1 material contained in submissions will be treated confidentially.

Written submissions should be addressed in writing to:

Chemistry and Manufacture Director Scientific Assessment and Chemical Review Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4701 Fax: +61 2 6210 4721 Email: [email protected]

1 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


Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations

The APVMA, in accordance with subsection 31(1) of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code), has initiated a reconsideration of the active constituent approvals and product registrations listed in Attachment 1. These active constituents and products were approved or registered after the commencement of the original reconsideration.

From 1 July 2015, new legislative requirements became applicable to all reconsiderations. These requirements include the preparation of a work plan for each reconsideration and that each reconsideration must be completed within the timeframe prescribed by the regulations.

The APVMA has published the work plans along with the prescribed timeframes on its website for all the reconsiderations currently in progress.

In order to apply all the legislative requirements uniformly to all the approvals and registrations when the corresponding chemical is under review, the APVMA will cease the practice of placing a condition at the time of granting the approval or registration, providing that they would be subject to the outcomes of the corresponding chemical review. Instead, it will reconsider the new approvals and registrations under subsection 31(1) of the Agvet Code.

Further details about the APVMA chemical review program or details of individual chemical reviews can be obtained from the APVMA website www.apvma.gov.au or by request to the Chemical Review Liaison Officer on +61 2 6210 4749 or [email protected].

APVMA CONTACT

Liaison Officer Chemical Review Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604

Phone: +61 2 6210 4749 Fax: +61 2 6210 4776 Email: [email protected]





ATTACHMENT 1: ACTIVE CONSTITUENT APPROVALS AND PRODUCT REGISTRATIONS PLACED UNDER RECONSIDERATION

2,4-D

Active constituent approvals included in the 2,4-D review

Active number Active name Holder 70447 2,4-D SABAKEM PTY LTD 70214 2,4-D UPL AUSTRALIA LIMITED

Registered products (along with their labels) included in the 2,4-D review

Product number Product name Holder 81968 AC RAMPANT SELECTIVE HERBICIDE AXICHEM PTY LTD 81945 ROTAM 2,4-D AMINE 625 HERBICIDE ROTAM AGROCHEMICAL CO., LTD 81936 ROTAM 2,4-d ESTER 680 HERBICIDE ROTAM AGROCHEMICAL CO., LTD 81794 ACP AMINEX 700 SELECTIVE HERBICIDE AUSTRALIS CROP PROTECTION

PTY LTD 81788 REYLON OPTANE LV 680 HERBICIDE RURALCO HOLDINGS LIMITED 81704 APPARENT HARDBALL 700 DUAL SELECTIVE

HERBICIDE APPARENT PTY. LTD

81242 NUFARM NUCOL HERBICIDE NUFARM AUSTRALIA LIMITED 80713 APPARENT RAMJET 75-D HERBICIDE APPARENT PTY. LTD 80105 WELLFARM 2,4-D ETHYL-ESTER 680 EC

HERBICIDE WELLFARM PTY LTD

70408 ACCENSI 2,4-D AMINE 700 DUAL SELECTIVE HERBICIDE

ACCENSI PTY LTD

70159 LOVELAND PRODUCTS WHITEOUT 2,4-D HERBICIDE

LOVELAND PRODUCTS, INC.

81288 VORTEX HERBICIDE ADAMA AUSTRALIA PTY LIMITED

Chlorpyrifos

Active constituent approvals included in the chlorpyrifos review

Active number Active name Holder 81656 CHLORPYRIFOS SANONDA (AUSTRALIA) PTY LTD 80115 CHLORPYRIFOS AIMCO KR AUSTRALIA PTY LTD

Registered products (along with their labels) included in the chlorpyrifos review

Product number Product name Holder 81786 REYLON CHLORPHOS 500EC INSECTICIDE RURALCO HOLDINGS LIMITED 81398 PRESOR TC TERMITICIDE & INSECTICIDE PREMIER SHUKUROGLOU AU PTY

LTD 81041 PRESOR 45 EC TERMITICIDE & INSECTICIDE PREMIER SHUKUROGLOU

CYPRUS LTD 80093 OZTEC CHLORPYRIFOS 500EC INSECTICIDE OZTEC RURAL PTY LTD 70410 PYRIGRAN INSECTICIDE SULPHUR MILLS AUSTRALIA PTY

LIMITED



Fipronil

Active constituent approvals included in the fipronil review

Active number Active name Holder 81180 FIPRONIL AGRO-ALLIANCE (AUSTRALIA)

PTY LTD

Registered products (along with their labels) included in the fipronil review

Product number Product name Holder 82098 PURINA TOTAL CARE FLEA CONTROL FOR

CATS NESTLE PURINA PETCARE A DIV OF NESTLE AUSTRALIA LTD

82097 PURINA TOTAL CARE FLEA AND TICK CONTROL FOR LARGE DOGS

NESTLE PURINA PETCARE A DIV OF NESTLE AUSTRALIA LTD

82050 AGRO-ESSENCE FIPRONIL 200SC INSECTICIDE

AGRO-ALLIANCE (AUSTRALIA) PTY LTD

81036 SUREFIRE PRO COCKROACH GEL BAIT PCT HOLDINGS PTY LTD 80985 SN ROACH BAIT SHANGHAI SHENGNONG

INTERNATIONAL CO., LTD 80736 ENVIROMAX FIPRONIL COCKROACH GEL

BAIT ENVIROMAX TECHNOLOGIES PTY LTD

80591 PROFILL FIP GRANULAR ANT KILLER PROFILL INDUSTRIES PTY LTD 70346 TERMIDOR FOAM TERMITICIDE &

INSECTICIDE BASF AUSTRALIA LTD

67414 FLEAAWAY SPRAY FOR CATS AND DOGS ARKOLETTE PTY LTD T/A RIVERSIDE VETERINARY PRODUCTS

80107 SMAL FIPRONIL GEL COCKROACH BAIT SULPHUR MILLS AUSTRALIA PTY LIMITED

66187 MONARCH INSECTICIDE TURF CULTURE PTY LTD 67882 CROP CULTURE ANCESTOR INSECTICIDE CROP CULTURE PTY LTD 67546 GENFARM FIPRONIL 200 INSECTICIDE LANDMARK OPERATIONS LIMITED 65422 ALBATROSS 200SC INSECTICIDE ADAMA AUSTRALIA PTY LIMITED 65307 ENVIROMAX FIPRONIL 100SC TERMITICIDE &

INSECTICIDE ENVIROMAX TECHNOLOGIES PTY LTD

63502 TERMINADE RESIDUAL TERMITICIDE AND INSECTICIDE

PCT HOLDINGS PTY LTD

82100 PURINA TOTAL CARE FLEA AND TICK CONTROL FOR SMALL DOGS


82099 PURINA TOTAL CARE FLEA AND TICK CONTROL FOR MEDIUM DOGS


67463 WARDEN RESIDUAL TERMITICIDE ADAMA AUSTRALIA PTY LIMITED



Paraquat

Registered products (along with their labels) included in the paraquat review

Product number Product name Holder 81974 NORWEED 250SL HERBICIDE ROTAM AGROCHEMICAL CO., LTD 81797 REYLON PARAQUICK 250 HERBICIDE RURALCO HOLDINGS LIMITED

Registered paraquat and diquat combination products (along with their labels) included in the paraquat review

Product number Product name Holder 81790 REYLON SPRAYQUICK HERBICIDE RURALCO HOLDINGS LIMITED

Polihexanide

Registered products (along with their labels) included in the polihexanide review

Product number Product name Holder 70073 SAFE4 DISINFECTANT CLEANER

CONCENTRATE SAFE4 ALL (AUST) PTY LTD

Dimethoate

Active constituent approvals included in the dimethoate review

Active number Active name Holder 80465 DIMETHOATE SHANDONG RAINBOW

INTERNATIONAL CO., LTD

Registered products (along with their labels) included in the polihexanide review

Product number Product name Holder 66538 ACP DIMETHOATE 400 SYSTEMIC

INSECTICIDE AUSTRALIS CROP PROTECTION PTY LTD

Procymidone

Registered products (along with their labels) included in the procymidone review

Product number Product name Holder 70284 IMTRADE NOSCLEX 800 WG FUNGICIDE IMTRADE AUSTRALIA PTY LTD



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

54128 INTERNATIONAL TRILUX HARD ANTIFOULING FOR ALUMINIUM

AKZO NOBEL PTY LIMITED 17 May 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 17 May 2016 at wholesale and retail level, until the 17 May 2017.

After 17 May 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 17 May 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 17 May 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 Australian Pesticides and Veterinary Medicines Authority PO Box 6182 SYMONSTON ACT 2609 Phone: +61 2 6210 4749 Fax: +61 2 6210 4776 Email: [email protected]

Cancellation of Registration at the Request of the Holder



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 Holder Cancelled Label Approvals

Date of effect

60493 ECOPAR HERBICIDE SIPCAM PACIFIC AUSTRALIA PTY LTD

60493/59329 17 May 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 17 May 2016 at wholesale and retail level, until 17 May 2017.

After 17 May 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 17 May 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 17 May 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 Australian Pesticides and Veterinary Medicines Authority PO Box 6182 SYMONSTON ACT 2609 Phone: +61 2 6210 4749 Fax: +61 2 6210 4776 Email: [email protected]

Cancellation of Label Approval at the Request of the Holder



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. 7).

The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012.

The MRL Standard is accessible via the ComLaw website www.comlaw.gov.au or the links above.

For further information please contact:

MRL Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4897 Fax: +61 2 6210 4840 Email: [email protected]

Amendments to the APVMA MRL Standard

http://www.comlaw.gov.au/Current/F2012L02501

http://www.comlaw.gov.au/Current/F2012L02501


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. 7)) 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.

Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code


PROPOSED AMENDMENT (AGRICULTURAL AND VETERINARY CHEMICALS CODE INSTRUMENT NO. 4 (MRL STANDARD) AMENDMENT INSTRUMENT 2016 (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

[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: prothioconazole

Permitted residue—commodities of plant origin: Sum of prothioconazole and prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole

Permitted residue—commodities of animal origin: Sum of prothioconazole, prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-3-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol) and prothioconazole-4-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-4-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole

Pulses T0.1

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

Agvet chemical: azoxystrobin

Permitted residue: azoxystrobin Rape seed (canola) T0.7

Agvet chemical: buprofezin

Permitted residue: buprofezin Walnut T0.05

Agvet chemical: cyproconazole

Permitted residue: cyproconazole, sum of isomers Rape seed (canola) T0.7



Agvet chemical: prothioconazole

Permitted residue—commodities of plant origin: Sum of prothioconazole and prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole

Permitted residue—commodities of animal origin: Sum of prothioconazole, prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-3-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol) and prothioconazole-4-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-4-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole Chick-pea (dry) T0.7 Lentil (dry) T0.7 Pulses [except Chick-pea (dry) and Lentil (dry)]

T0.1

Agvet chemical: spirotetramat

Permitted residue: 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

Pineapple T0.1



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) 28 June 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.






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. 3) gazetted on 8 March 2016 (No. APVMA 5).

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 5, 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.




http://www.comlaw.gov.au/


Australia New Zealand Food Standards Code—Schedule 20—Maximum residue

limits Variation Instrument No. APVMA 5, 2016

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 Twenty sixth day of May 2016



Part 1 Preliminary 1 Name of instrument This instrument is the Australia New Zealand Food Standards Code—

Schedule 20–Maximum residue limits Variation Instrument No. APVMA 5, 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 11 of 31 May 2016.

3 Object

The object of this instrument is for the APVMA to make variations to Schedule 20–Maximum 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 20–Maximum 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.

Variations to Schedule 20 of the Australia New Zealand Food Standards Code 31


Schedule

Variations to Schedule 20–Maximum residue limits

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

[1.1] omitting the chemical residue definition for Glyphosate and substituting the following

Permitted residue: Sum of glyphosate, N-acetyl-glyphosate and aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosate

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

Agvet chemical: acetamiprid

Permitted residue—commodities of plant origin: Acetamiprid

Permitted residue—commodities of animal origin: Sum of acetamiprid and N-demethyl acetamiprid ((E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyanoacetamidine), expressed as acetamiprid Pome fruits T0.5

Agvet chemical: acibenzolar-S-methyl

Permitted residue: acibenzolar-S-methyl and all metabolites containing the benzo[1,2,3]thiadiazole-7-carboxyl moiety hydrolysed to benzo[1,2,3]thiadiazole-7-carboxylic acid, expressed as acibenzolar-S-methyl Tomato 1

Agvet chemical: boscalid

Permitted residue—commodities of plant origin: Boscalid

Permitted residue—commodities of animal origin: Sum of boscalid, 2-chloro-N-(4′-chloro-5-hydroxybiphenyl-2-yl) nicotinamide and the glucuronide conjugate of 2-chloro-N-(4′-chloro-5-hydroxybiphenyl-2-yl) nicotinamide, expressed as boscalid equivalents Adzuki bean T3

Agvet chemical: clothianidin

Permitted residue: clothianidin Common bean (dry) (navy bean) T0.1 Mung bean (dry) T0.1



Agvet chemical: flonicamid

Permitted residue: flonicamid [N -(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide] and its metabolites TFNA [4-trifluoromethylnicotinic acid], TFNA-AM [4-trifluoromethylnicotinamide] TFNG [N -(4-trifluoromethylnicotinoyl)glycine]

Tomato T0.5

Agvet chemical: metalaxyl

Permitted residue: metalaxyl

Walnuts T0.3

Agvet chemical: metsulfuron-methyl

Permitted residue: metsulfuron-methyl Mung bean (dry) T0.2

Agvet chemical: pymetrozine

Permitted residue: pymetrozine Strawberry T0.3

Agvet chemical: sulfoxaflor

Permitted residue: sulfoxaflor Pineapple T0.1 Strawberry T0.7

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

Agvet chemical: acetamiprid

Permitted residue—commodities of plant origin: Acetamiprid

Permitted residue—commodities of animal origin: Sum of acetamiprid and N-demethyl acetamiprid ((E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyanoacetamidine), expressed as acetamiprid

Cotton seed 0.07


apvma gazette no. 11, 31 may 2016

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