APVMA Gazette No. 9, 4 May 2021 · Web view2021/05/04 · Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 3

Gazette Agricultural andVeterinary Chemicals

No. APVMA 9, Tuesday, 4 May 2021

Published by the Australian Pesticides and Veterinary Medicines Authority

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 2023

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process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and

inquiries concerning reproduction and rights should be addressed to:

Assistant Director, Communications

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Sydney NSW 2001

Email: [email protected]

Website: 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.

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Commonwealth of Australia GazetteNo. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994

CONTENTS

Agricultural Chemical Products and Approved Labels.............................................................................................................

Veterinary Chemical Products and Approved Labels............................................................................................................

Approved Active Constituents................................................................................................................................................

New agricultural active constituent: polyoxin D zinc salt technical concentrate....................................................................

Amendments to the APVMA MRL Standard..........................................................................................................................

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

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


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. AGRICULTURAL PRODUCTS BASED ON EXSITING ACTIVE CONSTITUENTS

Application no.: 129486

Product name: IW Formaldehyde Solution

Active constituent/s: 400 g/L formaldehyde

Applicant name: IWTS Group Pty Ltd

Applicant ACN: 152 692 969

Summary of use: For use as a disinfectant for poultry houses

Date of registration: 13 April 2021

Product registration no.:

90609

Label approval no.: 90609/129486


Product name: Nufarm Low Volume Application Spreader

Active constituent/s: 500 g/L trisiloxane ethoxylate

Applicant name: Nufarm Australia Limited


Summary of use: For use as a low volume application spreader to be used with a range of fungicides, insecticides, plant regulators and foliar nutrients



90892



Product name: Raticate All-Weather Block - Difenacoum

Active constituent/s: 0.05 g/kg difenacoum

Applicant name: Freezone Public Health Pty Ltd


Summary of use: For the control of rats and mice in and around buildings



89556



Product name: Raticate All-Weather Block - Brodifacoum

Active constituent/s: 0.05 g/kg brodifacoum

Applicant name: Freezone Public Health Pty Ltd


Summary of use: For the control of rats and mice in and around buildings



89557





Product name: Titan Diflufenican Bromoxynil MCPA Herbicide

Active constituent/s: 250 g/L MCPA present as the ethyl hexyl ester, 150 g/L bromoxynil present as the octanoate, 25 g/L diflufenican

Applicant name: Titan Ag Pty Ltd


Summary of use: For the control of certain broadleaf weeds in winter cereals



90054



Product name: BroadForce MA Selective Herbicide

Active constituent/s: 200 g/L bromoxynil present as the octanoate, 200 g/L MCPA present as the ethyl hexyl ester

Applicant name: EnviroMint Ltd

Applicant ACN: N/A

Summary of use: For the control of weeds in commercial and home garden situations



90749



Product name: RAMIK Bars Rodenticide

Active constituent/s: 50 mg/kg diphacinone

Applicant name: Neogen Corporation

Applicant ACN: N/A

Summary of use: For the control of mice in and around industrial, commercial, agricultural and domestic buildings



89433



Product name: Apparent Imazing Herbicide

Active constituent/s: 33 g/L imazamox present as the ammonium salt, 15 g/L imazapyr present as the ammonium salt

Applicant name: Titan Ag Pty Ltd


Summary of use: For the early post-emergence control of certain annual grass and broadleaf weeds in imidazolinone-tolerant wheat, imidazolinone-tolerant barley and imidazolinone-tolerant canola



90651





Product name: Trio Bromoxynil MCPA 200 EC Herbicide

Active constituent/s: 200 g/L bromoxynil present as the octanoate, 200 g/L MCPA present as the ethyl hexyl ester

Applicant name: CTS Chemicals Pty Ltd


Summary of use: For the control of weeds in wheat, barley, cereal rye, triticale, linseed, grass pastures and turf



90631



Product name: Shin Etsu MD C Flex Pheromone Mating Disruption Agent

Active constituent/s: 41.7 g/400 dispensers (E,E) 8,10 dodecadien-1-ol, 21.7 g/400 dispensers dodecanol, 5.1 g/400 dispensers tetradecanol

Applicant name: Shin Etsu Chemical Co Ltd

Applicant ACN: N/A

Summary of use: For management of codling moth (Cydia pomonella) in apples and pears



89649



Product name: International Micron One Ablative Antifouling

Active constituent/s: Red: 516 g/L copper present as cuprous oxide, 46 g/L zineb. Blue: 514 g/L copper present as cuprous oxide, 46 g/L zineb. Black: 514 g/L copper present as cuprous oxide, 46 g/L zineb. Dover white: 489 g/L copper present as cuprous oxide, 44 g/L zineb

Applicant name: Akzo Nobel Pty Ltd


Summary of use: For use below the waterline on vessels to prevent marine growth



89985



Product name: MLChem Spray Grade Ammonium Sulphate 980 Herbicide Adjuvant

Active constituent/s: 980 g/kg ammonium sulphate

Applicant name: AgMerch Pty Ltd


Summary of use: For use with glyphosate based herbicides to minimise antagonism when tank mixing with flowable herbicides, and to improve performance under adverse environmental conditions



90633





Product name: Submarino Glyphosate 540 K Herbicide

Active constituent/s: 540 g/L glyphosate present as the potassium salt

Applicant name: Submarino Pty Ltd


Summary of use: For the control of many annual and perennial weeds



90634



Product name: CropSure Putback 250SC Plant Growth Regulator

Active constituent/s: 250 g/L paclobutrazol

Applicant name: CropSure Pty Ltd


Summary of use: To reduce vegetative growth in mango, stone fruit and apple trees



90638



Product name: Quali-Pro Nutmeg Herbicide

Active constituent/s: 480 g/L bentazone present as sodium salt

Applicant name: ADAMA Australia Pty Ltd


Summary of use: For control of nutgrass, Mullumbimby couch and certain broadleaf weeds in turf



90028



Product name: Deadant Fire Ant & Nuisance Ants Killer Granules

Active constituent/s: 0.25 g/kg fipronil

Applicant name: Sundew Solutions Pty Ltd


Summary of use: For control of argentine stem weevil and ants (including fire ants) in lawns, external surrounds of buildings and structures in the home garden



90647





Product name: Termicoat

Active constituent/s: 108 g/L of boron present as 350 g/L disodium octoborate tetrahydrate, 200 g/L orthoboric acid, 20 g/L benzalkonium chloride

Applicant name: Ian Marchesi

Applicant ACN: N/A

Summary of use: For control of termites, borers and insects in timber and masonry



89414



Product name: Sanonda Fluroxypyr 400 Herbicide

Active constituent/s: 400 g/L fluroxypyr present as the methyl heptyl ester

Applicant name: Sanonda (Australia) Pty Ltd


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



90653



Product name: Worthide Xtra Insecticide

Active constituent/s: 500 g/kg pymetrozine

Applicant name: Shandong Rainbow International Co Ltd

Applicant ACN: N/A

Summary of use: For the control of aphids in cotton, brassica vegetables, potatoes and stone fruit



89471



Product name: Earthcare Organic Weedkiller Ready To Use

Active constituent/s: 36.8 g/L nonanoic acid

Applicant name: Seasol International Pty Ltd


Summary of use: For the control of weeds, moss and algae in gardens, paths and driveways



90632





Product name: Gro-Sure Fluroxypyr 200 Herbicide

Active constituent/s: 200 g/L fluroxypyr present as the methyl heptyl ester

Applicant name: Agritrading Pty Ltd


Summary of use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, millets, pastures, sorghum, sugar cane, sweet corn and winter cereals. Also for the control of woody weeds in agricultural non-crop areas, commercial and industrial areas, pastures and right-of-ways



90693



Product name: CropSure Garnisha 600EC Herbicide

Active constituent/s: 600 g/L triclopyr present as the butoxyethyl ester

Applicant name: CropSure Pty Ltd


Summary of use: For the control of various woody and broadleaf weeds



90658



Product name: Prolink Liquid Larvicide Concentrate

Active constituent/s: 205.2 g/L (S)-methoprene

Applicant name: Wellmark International (Australia) Pty Ltd


Summary of use: For the prevention of adult mosquito emergence in a range of natural water harbourages



89714



Product name: Agro-Essence Clethodim 360 EC Herbicide

Active constituent/s: 360 g/L clethodim

Applicant name: Agro-Alliance (Australia) Pty Ltd


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, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans



90675





Product name: Clama 50SC Insecticide

Active constituent/s: 50 g/L emamectin present as emamectin benzoate

Applicant name: AgriNova New Zealand Limited

Applicant ACN: N/A

Summary of use: For the control of certain insect pests in brassica vegetables, grapes, capsicum, lettuce, sweet corn and tomatoes



89922



Product name: Trio Bromoxynil 250 Diflufenican 25 EC Herbicide

Active constituent/s: 250 g/L bromoxynil present as the octanoate ester, 25 g/L diflufenican

Applicant name: CTS Chemicals Pty Ltd


Summary of use: For the control of certain broadleaf weeds in winter cereals and pastures



90709


2. VARIATIONS OF REGISTRATION


Product name: Dreamstate Australian Bed Bug Killing Powder

Active constituent/s: 900 g/kg amorphous silica

Applicant name: Bed Bug Wholesale

Applicant ACN: N/A

Summary of variation:

To vary the distinguishing product name and the name that appears on the label from ‘Trident Australian Bed Bug Killing Powder’ to ‘Dreamstate Australian Bed Bug Killing Powder’

Date of variation: 7 April 2021


88325



Product name: Smart Scavenge Sterilised Grain Mouse Bait

Active constituent/s: 25 g/kg zinc phosphide

Applicant name: Crop Smart Pty Ltd



To vary the distinguishing product name and the name that appears on the label from ‘Smart Terminator Grain Mouse Bait’ to ‘Smart Scavenge Sterilised Grain Mouse Bait’



90334





Product name: Cavalier 500 SC Herbicide

Active constituent/s: 500 g/L oxyfluorfen

Applicant name: ADAMA Australia Pty Ltd



To add integrated vegetation management use in industrial areas, non-crop situations, roadside, rail and rights of way and in ornamental trees and to amend personal protective equipment for aerial and backpack applications



81077



Product name: Greenzone Termite Perimeter System

Active constituent/s: 1.2 g/kg bifenthrin

Applicant name: Green Zone Pty Ltd



To vary the distinguishing product name and the name that appears on the label from ‘Greenzone Perimeter System’ to ‘Greenzone Termite Perimeter System’



89294



Product name: Hy-Clor Blackout

Active constituent/s: 18.2 g/L copper (Cu) present as a complex blend of copper salts, 96 g/L benzalkonium chloride

Applicant name: Hy-Clor (Australia) Pty Ltd



To vary the name that appears on the label from ‘Hy-Clor SaltActive Salt Water Algaecide’ to ‘Hy-Clor SaltActiv Salt Water Algaecide’



66999



Product name: Bromakil Power Block For Rats And Mice

Active constituent/s: 0.05 g/kg bromadiolone

Applicant name: Liphatech S.A.S.

Applicant ACN: N/A


To vary the distinguishing product name and the name that appears on the label from ‘Generation Green Rodenticide Block’ to ‘Bromakil Power Block For Rats and Mice’



80388





Product name: Sabakem Imidacloprid 350SC Soil Insecticide

Active constituent/s: 350 g/L imidacloprid

Applicant name: Sabakem Pty Ltd



To add uses for banana weevil borer in bananas (lady finger) and banana rust and weevil borer in banana (cavendish)



69122



Product name: Salve Herbicide

Active constituent/s: 375 g/kg aminopyralid, 300 g/kg metsulfuron-methyl

Applicant name: Grow Choice Pty Ltd



To add uses for control of weeds in wheat, barley, triticale and cereal rye



88260



Product name: AC Pulverize 75-D Herbicide

Active constituent/s: 300 g/L 2,4-D present as the triisopropyl amine salt, 75 g/L picloram present as the triisopropyl amine salt

Applicant name: Axichem Pty Ltd



To amend the product label in line with the 2,4-D reconsideration final regulatory decision and add the uses in agricultural non-crop areas, commercial and industrial areas, pastures and rights of way under the permit to label project



64859



Product name: Farmalinx 2,4-D 625 Herbicide

Active constituent/s: 625 g/L 2,4-D present as the dimethylamine and diethanolamine salts

Applicant name: Farmalinx Pty Ltd



To amend the product label in line with the 2,4-D reconsideration final regulatory decision and add uses in fallow, hardwood and softwood plantations, cavendish bananas, agricultural non-crop areas, commercial and industrial areas, pastures, rights of way and oil tea tree under the permit to label project



64351





Product name: Ambitious Plant Growth Regulator

Active constituent/s: 10 g/L forchlorfenuron

Applicant name: AgriNova New Zealand Limited

Applicant ACN: 34 004 099 592


To extend the use to apples and cherries



65381



Product name: Macspred Trimac Industrial Herbicide

Active constituent/s: 880 g/kg terbacil, 40 g/kg sulfometuron-methyl

Applicant name: Macspred Pty Ltd.



To add the use in eucalypt plantations



54812



Product name: Instar Granular Insecticide

Active constituent/s: 0.25 g/kg fipronil

Applicant name: Sundew Solutions Pty Ltd



To add control of red imported fire ant and yellow crazy ant and updating the first aid instructions



68975



Product name: Dithane Rainshield Neo Tec Fungicide

Active constituent/s: 750 g/kg mancozeb

Applicant name: Corteva Agriscience Australia Pty Ltd



To update the first aid instructions and safety directions as per the FAISD Handbook



59688





Product name: Thiragranz Fungicide

Active constituent/s: 800 g/kg thiram




To add new uses in avocado and mango and extend vegetable uses to cover beans, cabbage and carrot



48621



Product name: Nufarm Intercept Herbicide

Active constituent/s: 33 g/L imazamox as the ammonium salt, 15 g/L imazapyr present as the ammonium salt




To add use in imidazolinone herbicide tolerant faba beans



69353



Product name: Amistar Xtra Fungicide

Active constituent/s: 200 g/L azoxystrobin, 80 g/L cyproconazole

Applicant name: Syngenta Australia Pty Ltd



To include the control of various diseases in pulses, sweet corn and maize



57949



Product name: Versys Insecticide

Active constituent/s: 100 g/L afidopyropen

Applicant name: BASF Australia Ltd



To extend uses to barley, wheat, canola and certain horticultural crops; to add claims for additional pests; and to allow aerial application in broadacre crops



82738




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


Product name: Ceftiofur – Ketoprofen Injectable

Active constituent/s: 150 mg/mL ketoprofen, 50 mg/mL ceftiofur (as hydrochloride)

Applicant name: South Yarra Pharma Pty Ltd


Summary of use: For the treatment of bovine respiratory disease (BRD) caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to ceftiofur and the reduction of associated clinical signs of inflammation or pyrexia



90614



Product name: Prolet 20 Mg Tablets For Dogs

Active constituent/s: 20 mg/tablets carprofen

Applicant name: Jurox Pty Ltd


Summary of use: For the relief of pain and inflammation in dogs



90710



Product name: Nilablend Lasalocid/Nicarbazin Anticoccidial Premix

Active constituent/s: 100 g/kg lasalocid sodium, 100 g/kg nicarbazin

Applicant name: Zoetis Australia Pty Ltd


Summary of use: For the prevention of coccidiosis in broiler chickens caused by E acervulina, E maxima, E tenella, E brunetti, E necatrix, E mitis and E praecox



89199





Product name: Vetmec Moxiguard Long Acting Injection For Sheep

Active constituent/s: 20 g/L moxidectin

Applicant name: Chemvet Australia Pty Ltd


Summary of use: For the registration of an injectable parasiticide indicated for the treatment and control of roundworms, nasal bot and itchmite in sheep and for protection against barber's pole for up to 4 months



90630





Product name: Proguard Jetting Liquid Sheep Blowfly Treatment

Active constituent/s: 500 g/L cyromazine

Applicant name: Nutrien Ag Solutions Limited


Summary of use: For the protection of long wool sheep against strike by blowfly (Lucilia cuprina), including organophosphate resistant strains



90649


2. LISTED REGISTRATIONS


Product name: Zamijoint For Dogs

Active constituent/s: 560 mg/g glucosamine hydrochloride (shellfish origin), 336 mg/g chondroitin sulphate (bovine origin)

Applicant name: Zamira Life Sciences Pty Ltd


Summary of use: For the long-term use to help improve joint health and function in dogs



90533


3. VARIATIONS OF REGISTRATION


Product name: Randlab Meloxicam Injection Anti-inflammatory Injection

Active constituent/s: 20 mg/mL meloxicam

Applicant name: Randlab Australia Pty Ltd



To vary the product registration and label approval to extend the use to sheep and align the label with the Veterinary Labelling Code



68070


4. VARIATION OF LABEL APPROVAL


Product name: Apex Clindamycin 75 Tablets

Active constituent/s: 75 mg/tablet clindamycin as clindamycin hydrochloride

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd



To amend the dosage and administration and storage sections of the label as well as to update the label to the current Veterinary Labelling Code



87331





Product name: Apex Clindamycin 150 Tablets

Active constituent/s: 150 mg/tablet clindamycin as clindamycin hydrochloride

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd



To amend the dosage and administration and storage sections of the label and update the label to the current Veterinary Labelling Code



70247



Product name: Eimeriavax 3M

Active constituent/s: Eimeria acervulina strain RA3+20 (greater or equal to) 50 oocysts, eimeria maxima strain MCK+10 (greater or equal to) 100 oocysts, eimeria tenella strain Rt3+15 (greater or equal to) 150 oocysts

Applicant name: Eimeria Pty Ltd



To update label instructions for diluting the vaccine



63631



Product name: Ceva Ketamine Injection

Active constituent/s: 100 mg/mL ketamine as hydrochloride

Applicant name: Ceva Animal Health Pty Ltd



To include in-use shelf life statement



37711




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 CONSTITUENT


Active constituent/s:

Oestriol

Applicant name: Intervet Australia Pty Ltd


Summary of use: For use in veterinary chemical products

Date of approval: 12 April 2021

Approval no.: 90810



Pentobarbital sodium

Applicant name: Virbac (Australia) Pty Ltd




Approval no.: 90759



Neomycin sulfate

Applicant name: Avet Health Pty Ltd




Approval no.: 90499



Lufeneron

Applicant name: Elanco Australasia Pty Ltd




Approval no.: 90513



Meloxicam

Applicant name: Abbey Laboratories Pty Ltd




Approval no.: 90428





Nicarbazin

Applicant name: Zoetis Australia Pty Ltd




Approval no.: 89603



Cyromazine

Applicant name: Elanco Australasia Pty Ltd




Approval no.: 89963



Metribuzin

Applicant name: Agrow Allied Ventures Pvt Ltd

Applicant ACN: N/A

Summary of use: For use in agricultural chemical products


Approval no.: 89825



Trifluralin

Applicant name: Zhejiang Yingxin Chemical Co Ltd

Applicant ACN: N/A



Approval no.: 90187



Pyroxasulfone

Applicant name: Grow Choice Pty Ltd




Approval no.: 90188

2. VARIATIONS OF ACTIVE CONSTITUENT



Triamcinolone acetonide

Applicant name: Jurox Pty Ltd



Variation of relevant particulars or conditions of an approved active constituent


Approval no.: 84374



New agricultural active constituent: polyoxin D zinc salt technical concentrate

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has an application for the approval of a new agricultural active constituent, polyoxin D zinc salt (which will be manufactured as a technical concentrate of the active constituent), for use as a fungicide.

Common name: Polyoxin D zinc salt

IUPAC name: Zinc 5-(2-amino-5-O-carbamoyl-2-deoxy-L-xylonamido)-1-(5-carboxy-1,2,3,4-tetrahydro-2,4-dioxopyrimidinyl)-1,5-dideoxy- ß-D-allofuranuronate

Chemical abstracts name: Zinc 5-[[2-amino-5-O-(aminocarbonyl)-2-deoxy-L-xylonoyl]amino]-1-(5-carboxy-3,4-dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,5-dideoxy-β-D-allofuranuronate

CAS number: 146659-78-1 (1:1 zinc salt)

Molecular formula: C17H21N5O14Zn (1:1 zinc salt)

Molecular weight: 586.76 g/mol (1:1 zinc salt)

Structure:

Chemical family: Peptide nucleosides.

Mode of action: Polyoxin D, the active portion of the polyoxin D zinc salt, competitively inhibits chitin synthase enzymes, leading to inhibition of septation, chaining, and osmotic swelling of the fungal cell.

SUMMARY OF THE APVMA’S EVALUATION

The APVMA has evaluated the chemistry aspects of polyoxin D zinc salt technical concentrate (identification, stability, physicochemical properties, manufacturing process, specifications, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.

The APVMA has considered the toxicological aspects of polyoxin D zinc salt, and concluded that there are no toxicological concerns regarding the approval of this active constituent. Neither an Acceptable Daily Intake (ADI) nor an Acute Reference Dose (ARfD) value is required for polyoxin D zinc salt due to its anticipated low levels of residues in food and low oral toxicity.

After consideration of recommendations by the Advisory Committee on Chemical Scheduling, the Scheduling Delegate made a final decision to include polyoxin D zinc salt in schedule 5 of the Standard for the Uniform Scheduling of Medicines and Poisons, with an implementation date of 1 October 2020.

On the basis of the data provided, and the toxicological assessment, it is proposed that the following active constituent standard be established for polyoxin D zinc salt technical concentrate:

Constituent Level



Polyoxin D zinc salt 209 g/kg minimum

Other compounds of toxicological significance are not expected to occur in polyoxin D zinc salt technical concentrate based on the raw materials and the manufacturing route used.

The APVMA is satisfied that the proposed use of polyoxin D zinc salt 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 polyoxin D zinc salt technical concentrate 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.

Please note: submissions will be published on the APVMA’s website, unless you have asked for the submission to remain confidential (see public submission coversheet).

Please lodge your submission with a public submission coversheet, which provides options for how your submission will be published.

Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.

Please send your written submission and coversheet by email or post to:

Email: [email protected]

Post:

Director Chemistry and Manufacture

Risk Assessment Capability


GPO Box 3262

Sydney NSW 2001


mailto:[email protected]

https://apvma.gov.au/node/72856

https://apvma.gov.au/node/72856


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 (MRL Standard) Instrument 2019. 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 (MRL Standard) Amendment Instrument (No. 4) 2021

The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code (MRL Standard) Instrument 2019.

The MRL Standard is accessible via the Federal Register of Legislation website.

For further information please contact:

MRL Contact Officer


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2401Email: [email protected]

Amendments to the APVMA MRL Standard


https://www.legislation.gov.au/Series/F2019L01105


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

In the previous notice on page 21 of APVMA Gazette No. 9, the APVMA gazetted amendments which it has approved to vary maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in the APVMA’s MRL Standard.

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 (MRL Standard) Amendment Instrument (No. 4) 2021) 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 Food Standards Australia New Zealand (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 Australian Government and the New Zealand Government 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.

A Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO) will be made.

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 VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE (4 May 2021)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

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

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

Cyantraniliprole

Permitted residue: Cyantraniliprole

Celery T7

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]

Fruiting vegetables, other than cucurbits T0.5Rape seed (canola) 0.5

Fluxapyroxad

Permitted residue: FluxapyroxadOats T0.2

Mefentrifluconazole

Permitted residue: MefentrifluconazoleBarley T0.2Oats T0.2Rape seed (canola) T0.05Wheat T0.03

Mesotrione

Permitted residue: Mesotrione

All other foods except animal commodities

0.01

Linseed T*0.01



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

Azoxystrobin

Permitted residue: AzoxystrobinBeetroot T*0.005

Carbendazim

Permitted residue: Sum of carbendazim and 2-aminobenzimidazole, expressed as carbendazim

Mushrooms T1

Imazapyr

Permitted residue: Imazapyr

Broad bean (dry) 0.07

Mefentrifluconazole

Permitted residue: Mefentrifluconazole

Edible offal (mammalian) T0.3Meat (mammalian) (in the fat) T0.2

Spiroxamine

Permitted residue: Commodities of plant origin: SpiroxaminePermitted residue: Commodities of animal origin: Spiroxamine carboxylic acid, expressed as spiroxamineBarley 0.03Podded pea (young pods) (snow and sugar snap)

T0.6



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) 1 JUNE 2021

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.

Please note: submissions will be published on the APVMA’s website, unless you have asked for the submission to remain confidential, or if the APVMA chooses at its discretion not to publish any submissions received (refer to the public consultation coversheet).

Please lodge your submission using the public consultation coversheet, which provides options for how your submission will be published.

Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.


MRL Contact Officer


GPO Box 3262

Sydney NSW 2001





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 proposal (No. 1) gazetted on 27 January 2021 (No. APVMA 2).

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 1, 2021) 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 Legislation available on the Legislation website.

Based on dietary exposure assessments and current health standards, the APVMA and Food Standards Australia and New Zealand (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 Australian Government and the New Zealand Government 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


GPO Box 3262

Sydney NSW 2001




http://www.legislation.gov.au/

http://www.legislation.gov.au/

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

Instrument No. APVMA 3, 2021

I, Sheila Logan, 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.

Sheila LoganDelegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority

Dated this Twenty-third day of April 2021


Part 1 Preliminary1 Name of instrument

This instrument is the Australia New Zealand Food Standards Code—Schedule 20maximum residue limits Variation Instrument No. APVMA 3, 2021 (Amendment Instrument).

2 CommencementIn 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.

3 ObjectThe 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 InterpretationIn this instrument: —APVMA means the Australian Pesticides and Veterinary Medicines Authority established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; andPrincipal 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 20The 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: Fomesafen

Permitted residue: Fomesafen

Edible offal (mammalian) *0.02Eggs *0.02Meat (mammalian) *0.02Milks *0.02Poultry, Edible offal of *0.02Poultry meat *0.02Pulses *0.01

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

Agvet chemical: Fluopyram

Permitted residue: Commodities of plant origin: FluopyramPermitted residue: Commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyram

Rape seed (canola) *0.01

Agvet chemical: Pyraflufen-ethyl

Permitted residue: Sum of pyraflufen-ethyl and its acid metabolite (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxyacetic acid)

Field pea (dry) *0.02

Agvet chemical: Spinetoram

Permitted residue: Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L

Leek T0.2Onion, bulb T*0.01Onion, Welsh T0.3Shallot T0.3Spring onion T0.3



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

Agvet chemical: Azoxystrobin

Permitted residue: AzoxystrobinSweet corn (corn-on-the-cob) *0.01

Agvet chemical: Bromoxynil

Permitted residue: Bromoxynil

Walnuts T*0.01

Agvet chemical: Diflufenican

Permitted residue: DiflufenicanWalnuts T*0.01


Permitted residue: Commodities of plant origin: FluopyramPermitted residue: Commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyram

Cereal grains 0.03Lettuce, head 15Lettuce, leaf 15Oilseed 0.03

Agvet chemical: Spinetoram

Permitted residue: Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-LBulb vegetables (alliums) 0.1Cacao beans *0.01Carob 0.1

Agvet chemical: Trifloxystrobin

Permitted residue: Sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)-ethylideneaminooxymethyl] phenyl] acetic acid), expressed as trifloxystrobin equivalents

Lettuce, head 15Lettuce, leaf 15



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


Permitted residue: Commodities of plant origin: FluopyramPermitted residue: Commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyramAll other foods except animal food commodities 0.2

Agvet chemical: Metalaxyl

Permitted residue: MetalaxylWalnuts T*0.01

Agvet chemical: Methomyl

Permitted residue: Methomyl

Mango T*0.01


Documents

APVMA Gazette No. 9, 4 May 2021 · Web view2021/05/04 · Commonwealth of Australia Gazette No. APVMA 9, Tuesday, 4 May 2021 Agricultural and Veterinary Chemicals Code Act 1994 3