apvma gazette no. 24, 1 december 2020...gazette agricultural and veterinary chemicals no. apvma 24,...

Gazette Agricultural and

Veterinary Chemicals

No. APVMA 24, Tuesday, 1 December 2020

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 2020

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:

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 requi red

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

The APVMA Gazette is published in electronic format only and is available from the APVMA website.

If you would like to subscribe to receive email notification when a new edition is published, please complete the subscription

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APVMA CONTACTS

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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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Commonwealth of Australia Gazette No. APVMA 24, Tuesday, 1 December 2020 Agricultural and Veterinary Chemicals Code Act 1994 3

CONTENTS

Agricultural Chemical Products and Approved Labels ..................................................................................................... 4

Veterinary Chemical Products and Approved Labels .................................................................................................... 14

Approved Active Constituents ....................................................................................................................................... 17

New Agricultural Active Constituent: Acequinocyl ......................................................................................................... 19

Amendments to the APVMA MRL Standard .................................................................................................................. 21

Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code ................................................. 22

Variations to Schedule 20 of the Australia New Zealand Food Standards Code ........................................................... 27

Stop Supply: Fleamail Pty Ltd (ACN 637 942 128)........................................................................................................ 32

Stop Supply: Ausrichter Pty Ltd (ACN 000 908 529) ..................................................................................................... 34


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 EXISTING ACTIVE CONSTITUENTS

Application no.: 124765

Product name: HL Clethodim 240 Herbicide

Active constituent/s: 240 g/L clethodim

Applicant name: Hebei Lansheng Biotech Co Ltd

Applicant ACN: N/A

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: 3 July 2020

Product registration no.: 89416

Label approval no.: 89416/124765


Product name: Yates Grub Kill & Protect For Lawns C Up To 6 Months Protection Against Curl Grub

Active constituent/s: 200 g/L chlorantraniliprole

Applicant name: Syngenta Australia Pty Ltd

Applicant ACN: 002 933 717

Summary of use: For the control of lawn grubs in the home garden

Date of registration: 10 July 2020




Product name: Searles Dead Grub Pro Hose-On For Lawns

Active constituent/s: 4.8 g/L bifenthrin

Applicant name: J.C. & A.T. Searle Pty Ltd


Summary of use: To control lawn beetles and lawn grubs in the home garden

Date of registration: 13 August 2020




Product name: eChem e-Strobin 250 SC Fungicide

Active constituent/s: 250 g/L azoxystrobin

Applicant name: eChem (Australia) Pty Ltd


Summary of use: For the control of various diseases of grapes, potatoes, tomatoes, cucurbits, avocados, mangoes, passionfruit and poppies

Date of registration: 28 October 2020






Product name: Nufarm Amishield 500WG Fungicide

Active constituent/s: 500 g/kg amisulbrom

Applicant name: Nufarm Australia Limited


Summary of use: For control of clubroot and suppression of damping off in brassicas and the control of powdery scab and suppression of pink rot in potatoes

Date of registration: 9 November 2020




Product name: Retacel 720 Plant Growth Regulant

Active constituent/s: 558 g/L chlormequat present as chlormequat chloride

Applicant name: Draslovka Services Pty Ltd


Summary of use: For use as an aid in increasing grain yield and prevention of lodging in wheat





Product name: Coromandel Fipronil 800 WG Insecticide

Active constituent/s: 800 g/kg fipronil

Applicant name: Sabero Australia Pty Ltd


Summary of use: For the control of various insect pests in bananas, brassicas, cotton, wine grapes, mushrooms, pasture, potatoes, sorghum and sugarcane





Product name: eChem e-Grex Selective Herbicide

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

Applicant name: Echem (Aust) Pty Ltd


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





Product name: JURA Herbicide

Active constituent/s: 667 g/L prosulfocarb, 14 g/L diflufenican

Applicant name: Globachem N.V.

Applicant ACN: N/A

Summary of use: For control of annual rye grass in wheat and barley







Product name: eChem Lambda 250 CS Insecticide

Active constituent/s: 250 g/L lambda-cyhalothrin

Applicant name: eChem (Aust) Pty Ltd


Summary of use: For the control of certain insect pests in cotton, barley, wheat and various field crops





Product name: Wynsate PRO 480 DMA Herbicide

Active constituent/s: 480 g/L glyphosate present as the dimethylammonium salt

Applicant name: Zhejiang Xinan Chemical Industrial Group Co Ltd

Applicant ACN: N/A

Summary of use: For non-selective control of many annual and perennial weeds in conservation tillage, pre - and post-harvest uses, agricultural and non-agricultural situations





Product name: Protim Optimum PTB Concentrate

Active constituent/s: 180 g/L tebuconazole, 180 g/L propiconazole, 34 g/L bifenthrin

Applicant name: Koppers Performance Chemicals Australia Pty Ltd


Summary of use: For the protection of softwood and hardwood timber in hazard level H3 (outside and above ground) situations





Product name: Hemani Jolt 800 EC Herbicide

Active constituent/s: 800 g/L prosulfocarb

Applicant name: Hemani Industries Limited

Applicant ACN: N/A

Summary of use: For the control of annual ryegrass (Lolium rigidum) and other grass and broadleaf weeds in barley and wheat





Product name: Sinon Pardnar 600 Herbicide

Active constituent/s: 600 g/kg metsulfuron-methyl

Applicant name: Sinon Australia Pty Ltd


Summary of use: For the control of brush and broadleaf weeds in native pastures, rights of way, commercial and industrial areas, for the control of certain broadleaf weeds in winter cereal crops and for pre-harvest desiccation in mung beans






2. VARIATIONS OF REGISTRATION


Product name: Rainbow Glufosinate 200 Herbicide

Active constituent/s: 200 g/L glufosinate-ammonium

Applicant name: Shandong Rainbow International Co Ltd

Applicant ACN: N/A

Summary of variation: To add uses in turf, summer fallow situations (cereal grains, pulses and oilseeds), commercial and industrial areas, forest plantations, rights-of-way and other non-agricultural areas

Date of variation: 8 October 2020




Product name: Kermit Bio 360 Herbicide

Active constituent/s: 360 g/L glyphosate present as the isopropylamine salt

Applicant name: Crop Culture Pty Ltd


Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Kermit 360 Herbicide’ to ‘Kermit Bio 360 Herbicide’





Product name: Kermit Bio 510 Herbicide

Active constituent/s: 510 g/L glyphosate present as the isopropylamine salt



Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Kermit 510 Herbicide’ to ‘Kermit Bio 510 Herbicide’





Product name: Accensi Oryzalin 500 Herbicide

Active constituent/s: 500 g/L oryzalin

Applicant name: Accensi Pty Ltd


Summary of variation: To add use against broadleaf and grass weeds in ginger and duboisia







Product name: Pooled Energy Bromide Up

Active constituent/s: 995 g/kg sodium bromide

Applicant name: Pooled Energy Pty Ltd


Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Pooled Energy Pool Sanitizer Precursor’ to ‘Pooled Energy Bromide Up’





Product name: ProGuard Granular Pool Sanitiser

Active constituent/s: 660 g/kg chlorine present as trichloroisocyanuric acid

Applicant name: Biolab Australia Pty Ltd


Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Proguard Trichlor Plus Granules Pool Sanitiser’ to ‘Proguard Granular Pool Sanitiser’





Product name: Barmac Trifluralin 480 Herbicide

Active constituent/s: 480 g/L trifluralin

Applicant name: Amgrow Pty Ltd


Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Barmac Tri-Max 480 Herbicide’ to ‘Barmac Trifluralin 480 Herbicide’

Date of variation: 6 November 2020




Product name: Skope Insecticide

Active constituent/s: 218 g/L acetamiprid, 32.5 g/L emamectin present as emamectin benzoate

Applicant name: ADAMA Australia Pty Ltd


Summary of variation: To extend use to include control of various pests in pulses and control of jassids and two-spotted mite in cotton







Product name: Accensi Metolachlor 960 Herbicide

Active constituent/s: 960 g/L metolachlor

Applicant name: Accensi Pty Ltd


Summary of variation: To add the instructions for multiple pests in mustard, various broadleaf and grass weeds in spinach, silverbeet, spring onions, shallots, green beans and navy beans and certain annual grasses and broadleaf weeds in adzuki beans and mung beans





Product name: Family Protection Aerogard Body Odourless Protection 6 Hours Protection Low Irritant* Great For Kids 12 Months+ Insect Repellent Spray

Active constituent/s: 92.8 g/L picaridin

Applicant name: RB (Hygiene Home) Australia Pty Ltd


Summary of variation: To change product name, expand registered pack sizes, add additional manufacturing sites and amend approved label





Product name: Oskar 540 Herbicide

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



Summary of variation: To add additional situations including control of various weeds in pasture





Product name: Imtrade Simazine 900 WG Herbicide

Active constituent/s: 900 g/kg simazine

Applicant name: Imtrade Australia Pty Ltd


Summary of variation: To add the following uses under the Permit to Label Project: broadleaf weeds and grasses in almonds, various pests in pyrethrum crops, weed control in walnuts, specified grass and broadleaf weeds in leeks, various pests and diseases in tea tree oil, broadleaf and grass weeds in ginger (Zingiber officinale), weed and sucker control in hazel nuts, various weeds in nursery stock (non-food), foliage, cut flowers and wildflowers







Product name: Chemag Thor 250EC Herbicide

Active constituent/s: 125 g/L oryzalin, 125 g/L trifluralin



Summary of variation: To add a use for the control of weeds in mustard





Product name: Trelona Termite Bait

Active constituent/s: 5 g/kg novaluron

Applicant name: BASF Australia Ltd


Summary of variation: To include use in above ground baiting stations for the control of subterranean termites and the protection of structures





Product name: Imtrade Tebuconazole 430 SC Fungicide

Active constituent/s: 430 g/L tebuconazole



Summary of variation: To add the following use instructions: duboisia, anise myrtle, lemon myrtle, oil tea tree, beetroot, beetroot leaves, carrots, chicory, endive, radish, silverbeet, spinach, mung beans, faba beans, broad beans, soya beans, garlic, walnuts and non-food producing plants including nursery stock





Product name: Nufarm Avadex Xtra Selective Herbicide

Active constituent/s: 500 g/L triallate



Summary of variation: To add a new use in wheat and to add uses under the Permit to Label Project





Product name: Timbertreat A Azole Insecticide/Fungicide Wood Preservative

Active constituent/s: 125 g/L propiconazole, 125 g/L tebuconazole, 83 g/L permethrin

Applicant name: Kop-Coat Australia Pty Ltd


Summary of variation: To add uses for the treatment of eucalyptus nitens timber decking using a spray flood coating system







Product name: Conquest Tricon Flexi 480 Selective Herbicide

Active constituent/s: 480 g/L trifluralin

Applicant name: Conquest Crop Protection Pty Ltd


Summary of variation: To add uses in legumes, oilseeds, peppers and eggplant, quinoa, parsnips, swede, turnip, duboisia and industrial hemp





Product name: Conquest Triagra 500 EC Selective Herbicide

Active constituent/s: 500 g/L triallate

Applicant name: Conquest Crop Protection Pty Ltd


Summary of variation: To add new uses for control of grasses and broadleaf weeds in wheat, barley, triticale and canola





Product name: Biotrap DDVP Cubes

Active constituent/s: 186 g/kg dichlorvos (an anticholinesterase compound)

Applicant name: Bio-trap Australia Pty Ltd


Summary of variation: To extend the use of the product to monitor/control insects more broadly in commercial orchards and other horticultural crops





Product name: Apparent Expunge 600 FS Insecticide

Active constituent/s: 600 g/L imidacloprid

Applicant name: Titan Ag Pty Ltd


Summary of variation: To amend the formulation type of the product and update the product name to ‘Apparent Expunge 600 FS Insecticide’







Product name: Imtrade Metal Gold 960 EC Herbicide

Active constituent/s: 960 g/L S-Metolachlor



Summary of variation: To add the control of various weeds in rhubarb, various broadleaf and grass weeds in brassica leafy vegetables, multiple pests in mustard, various broadleaf and grass weeds in spinach, silverbeet, spring onions, shallots, green beans and navy beans and various weeds in culinary herbs





Product name: Agri-Fos 600 Systemic Fungicide

Active constituent/s: 600 g/L phosphorous (phosphonic) acid as mono-di k phosphonate

Applicant name: Liquid Fertiliser Pty Ltd


Summary of variation: To shorten the withholding period for macadamias from 28 days to 14 days





Product name: Amgrow Chemspray Weed Control Tree & Blackberry Killer

Active constituent/s: 50 g/L triclopyr present as the butoxyethyl ester

Applicant name: Amgrow Pty Ltd


Summary of variation: To include additional pack sizes





Product name: Imtrade Metal Plus 960 EC Herbicide

Active constituent/s: 960 g/L metolachlor



Summary of variation: To add uses for multiple pests in mustard, various broadleaf and grass weeds in spinach, silverbeet, spring onions, shallots, green beans and navy beans, certain annual grasses and broadleaf weeds in adzuki beans and mung beans







Product name: Surefire Tusk Fungicide

Active constituent/s: 430 g/L tebuconazole

Applicant name: PCT Holdings Pty Ltd


Summary of variation: To add uses in duboisia, oil tea tree, anise myrtle, lemon myrtle, non-food producing plants and vegetation, beetroot, beetroot leaves, chicory, endive, radish, silverbeet, spinach, carrots, mung beans, faba beans, broad beans, soya beans, walnuts and garlic





Product name: Sinker Fungicide

Active constituent/s: 500 g/L flutriafol



Summary of variation: To update first aid instructions and storage and disposal directions




3. VARIATION OF LABEL APPROVAL


Product name: Chippolay Selective Herbicide

Active constituent/s: 700 g/kg methabenzthiazuron

Applicant name: Agnova Technologies Pty Ltd


Summary of variation: To delete a maximum rate on the product label and add a recommendation to tank mix





Veterinary Chemical Products and Approved Labels



Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of

the registration in respect of the following products and has approved the label or varied the relevant particulars or

conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Cura-Linc 790 g/kg Antibiotic Soluble Powder

Active constituent/s: 1,000 g/kg lincomycin hydrochloride equivalent to not less than 790 g/kg lincomycin base

Applicant name: Probus Pharmaceuticals Pty Ltd


Summary of use: For treatment of swine dysentery caused by Serpulina hyodysenteriae in pigs





Product name: Di-Fly Extra Spray-On Blowfly Treatment For Sheep

Active constituent/s: 65 g/L dicyclanil

Applicant name: Abbey Laboratories Pty Ltd


Summary of use: For the protection of sheep against fly strike and the protection of mulesing and marking wounds on sheep against fly strike during the wound healing process





Product name: Vanguard Intranasal Resp 3 Live Vaccine For Dogs

Active constituent/s: Each dose contains live attenuated: Canine Adenovirus Type 2 (≥10^3.1 TCID50), Canine Parainfluenza Virus (≥10^5.0 TCID50), Bordetella bronchiseptica (≥1.3 x 10^6 CFU)

Applicant name: Zoetis Australia Pty Ltd


Summary of use: For the active immunisation of healthy dogs and puppies from 8 weeks of age to reduce clinical signs associated with respiratory tract disease and shedding induced by Bordetella bronchiseptica, Canine Parainfluenza Virus (CPI) and Canine Adenovirus Type 2 (CAV-2)







Product name: Kefvet Oral Antibiotic Drops For Dogs And Cats

Active constituent/s: 150 mg/g cephalexin

Applicant name: Bocko P/L & Flexsky P/L In Partnership

Applicant ABN: 57 147 389 678

Summary of use: For treatment of susceptible infections of the respiratory tract, urogenital tract, the skin and localised infections in soft tissues of dogs and cats




2. VARIATIONS OF REGISTRATION


Product name: ZeroMec Premix For Pigs

Active constituent/s: 6 g/kg ivermectin

Applicant name: Abbey Laboratories Pty Ltd


Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘I-Mec Premix For Pigs’ to ‘ZeroMec Premix For Pigs’



Label approval no.: 87145 / 128488

Application no: 126120

Product name: Equine Joint Support Formula 2

Active constituent/s: 200 g/kg glucosamine sulphate (marine exoskeleton), 60 g/kg sodium chondroitin sulphate (bovine cartilage)

Applicant name: International Animal Health Products Pty Ltd


Summary of variation: To vary the claim statement and to add 2 pack sizes





Product name: Milbemax Tablets for Small Cats

Active constituent/s: 10 mg/tb praziquantel, 4 mg/tb milbemycin oxime

Applicant name: Elanco Australasia Pty Ltd


Summary of variation: To update the wording of the approved label







Product name: Milbemax Tablets for Cats

Active constituent/s: 40 mg/tb praziquantel, 16 mg/tb milbemycin oxime

Applicant name: Elanco Australasia Pty Ltd


Summary of variation: To update the wording of the approved label





Product name: Clomav 80mg Tablets

Active constituent/s: 80 mg/tb clomipramine hydrochloride equivalent to 72 mg clomipramine

Applicant name: Mavlab Pty Ltd


Summary of variation: To add 2 additional pack sizes






Active constituent/s: 20 mg/tb clomipramine hydrochloride equivalent to 18 mg clomipramine









Active constituent/s: 5 mg/tb clomipramine hydrochloride equivalent to 4.5 mg clomipramine








Product name: Troy Behave Equine – Tryptophan and Vitamin Supplement Paste

Active constituent/s: 333 mg/mL L-tryptophan

Applicant name: Troy Laboratories Pty Ltd


Summary of variation: To add a new pack size





Approved Active Constituents



Code Act 1994, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of

the approval of the following active constituents, with effect from the dates shown.

1. ACTIVE CONSTITUENT


Active constituent/s: Clothianidin



Summary of use: For use in agricultural chemical products

Date of approval: 10 November 2020

Approval no.: 89452


Active constituent/s: Clothianidin





Approval no.: 89418


Active constituent/s: 2,4-D 2-ethylhexyl ester

Applicant name: Kenso Corporation (M) Sdn Bhd

Applicant ACN: N/A



Approval no.: 89105


Active constituent/s: 2,4-D isobutyl ester

Applicant name: 4 Farmers Australia Pty Ltd




Approval no.: 88976


Active constituent/s: Maropitant citrate

Applicant name: Zoetis Australia Ltd


Summary of use: For use in veterinary chemical products


Approval no.: 89769




Active constituent/s: 2,4-D-2-ethylhexyl ester

Applicant name: Niensis Pty Ltd




Approval no.: 89021


Active constituent/s: Bordetella bronshiseptica

Applicant name: Zoetis Australia Pty Ltd


Summary of use: For use in veterinary chemical products


Approval no.: 83114


Active constituent/s: Fluazifop-P-butyl

Applicant name: Shandong Binnong Technology Co Ltd

Applicant ACN: N/A



Approval no.: 89506


Active constituent/s: Abamectin

Applicant name: Shanghai E-Tong Chemical Co Ltd

Applicant ACN: N/A



Approval no.: 89524


New Agricultural Active Constituent: Acequinocyl


The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a

new active constituent, acequinocyl, for use in the control of all immature life stages of spider mites in greenhouses and

shade houses on container-grown ornamental, floral, foliage and nursery crops as well as on field-grown ornamentals

and pome fruit using ground application equipment.

PARTICULARS OF THE ACTIVE CONSTITUENT

Common name: Acequinocyl

IUPAC name: 3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate

CAS name: 2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione

CAS registry number: 57960-19-7

Minimum purity: 960 g/kg

Molecular formula: C24H32O4

Molecular weight: 384.5 gmol-1

Structure:

Chemical family: 1,4-naphthoquinone

SUMMARY OF THE APVMA’S EVALUATION OF ACEQUINOCYL ACTIVE CONSTITUENT

The APVMA has evaluated the chemistry aspects of active constituent acequinocyl (physico-chemical properties,

identification, spectra, manufacturing process, quality control procedures, batch analysis results and analytical methods)

and found them to be acceptable.

The APVMA has considered the toxicological aspects of acequinocyl, and concluded that there are no toxicological

concerns regarding the approval of this active constituent. An acceptable daily intake (ADI) for acequinocyl was

established at 0.023 mg/kg bw/day, while an acute reference dose (ARfD) was established at 0.08 mg/kg bw. No

toxicologically significant impurities have been identified in acequinocyl technical active constituent.

The Scheduling Delegate made a final decision to included acequinocyl in Schedule 5 of the SUSMP with no cut-off or

exemption, and with effect from 1 June 2020.

On the basis of the data provided, and the toxicological assessment, it is proposed that the following active constituent

standard be established for acequinocyl:

Constituent Level

Acequinocyl Minimum purity 960 g/kg



Other compounds of toxicological significance are not expected to occur in acequinocyl as a result of the raw materials

and the synthetic route used.

The APVMA is satisfied that the proposed importation and use of acequinocyl would not be an undue toxicological

hazard to the safety of people exposed to it during its handling and use.

FURTHER INFORMATION

A Public Release Summary (PRS) of the evaluations of the active and the associated product is available from the APVMA

website’s ‘Public Consultation’ page.

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 acequinocyl 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:


Post:

Director of Chemistry and Manufacture

Risk Assessment Capability


GPO Box 3262

Sydney NSW 2001

https://apvma.gov.au/news-and-publications/public-consultationshttps://apvma.gov.au/node/72856https://apvma.gov.au/node/72856mailto:[email protected]


Amendments to the APVMA MRL Standard

Amendments to the APVMA MRL Standard

The Australian Pesticides and Veterinary Medicines Authority (APVMA) approves maximum residue limits (MRLs) of

agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. The MRLs

approved by the APVMA are associated with a regulatory decision to register a product, grant a permit approval, or as an

outcome from a review decision and are set out in the Agricultural and Veterinary Chemicals Code (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. 10) 2020.

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 2401


https://www.legislation.gov.au/Series/F2019L01105mailto:[email protected]


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


In the previous notice on page 21 of APVMA Gazette No. 24, 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. 10) 2020) 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

(1 December 2020)

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: 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

Avocado 0.05

Mango 0.05

Agvet chemical: cyproconazole

Permitted residue – cyproconazole, sum of isomers

Chick-pea (dry) 0.03

Lentil (dry) 0.03

Agvet chemical: pyriproxyfen

Permitted residue – pyriproxyfen

Avocado 0.05

Mango 0.05

Olives 1

[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

Assorted tropical and sub-tropical fruits – inedible peel

0.2

Olives for oil production T0.5

Persimmon, Japanese T0.3

Table olives T0.5



Agvet chemical: afidopyropen

Permitted residue – commodities of plant origin: afidopyropen

Permitted residue – commodities of animal origin: afidopyropen and the carnitine conjugate of cyclopropanecarboxylic acid (M440I060), expressed as afidopyropen

Artichoke, globe 0.1

Barley *0.01

Rape seed [canola] *0.01

Rhubarb 0.1

Sweet corn (corn-on-the-cob) *0.01

Wheat *0.01



Pulses 0.05

Sweet corn (corn-on-the-cob) *0.01

Agvet chemical: flumioxazin

Permitted residue – flumioxazin

Banana T*0.02

Agvet chemical: pyriproxyfen

Permitted residue – pyriproxyfen

Assorted tropical and sub-tropical fruits – inedible peel

0.3

Olives for oil production 1

Persimmon, Japanese T0.2

Table olives 1

Agvet chemical: tetraniliprole

Permitted residue – tetraniliprole

All other foods except animal commodities

0.02

Mango T0.2

Meat (mammalian) *0.01



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

Agvet chemical: afidopyropen

Permitted residue – commodities of plant origin: Afidopyropen

Permitted residue – commodities of animal origin: Afidopyropen and the carnitine conjugate of cyclopropanecarboxylic acid (M440I060), expressed as afidopyropen

Carrot *0.01

Strawberry 0.2

Agvet chemical: azoxystrobin

Permitted residue – azoxystrobin

Maize *0.01



Maize *0.01



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 (AEDT) 4 JANUARY 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

Phone: +61 2 6770 2401


https://apvma.gov.au/node/72856https://apvma.gov.au/node/72856https://apvma.gov.au/node/72856mailto:[email protected]


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


The APVMA has previously gazetted particular amendments which it had made to the APVMA MRL Standard and which

have been proposed as variations to maximum residue limits (MRLs) for substances contained in agricultural and

veterinary chemical products as set out as in Schedule 20 – Maximum residue limits of the Australia New Zealand Food

Standards Code. This notice pertains to proposals (No. 7) gazetted on 8 September 2020 (No. APVMA 18).

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

10, 2020) 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.

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

Phone: +61 2 6770 2383


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



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

Instrument No. APVMA 9, 2020

I, Jason Lutze, 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.

Jason Lutze

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

Authority

Dated this Twenty Fourth day of November 2020



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 9. 2020 (Amendment Instrument).

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.

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.



Schedule

Variations to Schedule 20 – Maximum residue limits

[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: metribuzin

Permitted residue – metribuzin

Root and tuber vegetables [except carrot; potato]

T*0.05

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)

Broad bean (dry) (fava bean) *0.02

Field bean (dry) *0.02

Agvet chemical: saflufenacil

Permitted residue – commodities of plant origin: sum of saflufenacil, N′-{2-chloro-4-fluoro-5-[1,2,3,6-tetrahydro-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]benzoyl-N-isopropyl sulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino} carbonyl)phenyl]urea, expressed as saflufenacil equivalents

Permitted residue – commodities of animal origin: saflufenacil

Cereal grains 0.2

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

Agvet chemical: imidacloprid

Permitted residue – sum of imidacloprid and metabolites containing the 6-chloropyridinylmethylene moiety, expressed as imidacloprid

Galangal, lesser T0.05

Ginger, Japanese T0.05

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)

Pulses *0.02



Agvet chemical: saflufenacil

Permitted residue – commodities of plant origin: sum of saflufenacil, N′-{2-chloro-4-fluoro-5-[1,2,3,6-tetrahydro-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]benzoyl-N-isopropyl sulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino} carbonyl)phenyl]urea, expressed as saflufenacil equivalents

Permitted residue – commodities of animal origin: saflufenacil

Cereal grains (except rice) 0.2

Rice *0.01

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

Agvet chemical: clothianidin

Permitted residue: clothianidin

see also thiamethoxam

Almonds 0.05

Agvet chemical: fluralaner

Permitted residue – fluralaner

Cattle fat T0.7

Cattle kidney T0.25

Cattle liver T0.6

Cattle muscle T0.07

Agvet chemical: metribuzin

Permitted residue – metribuzin

Ginger root T*0.01


Stop Supply: Fleamail Pty Ltd (ACN 637 942 128)


NOTICE UNDER SECTION 103 OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE SCHEDULED TO

THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994 (CTH) (AGVET CODE) – NO. 23 OF 2020

On 24 November 2020, the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to

Fleamail Pty Ltd ACN 637 942 128 (‘the Company’), pursuant to section 103 of the Agvet Code in relation to the

registered chemical products set out in the Schedule below (‘the Products’).

This notice required the Company to immediately not supply, or stop supplying, to any person, stocks of the Products

which do not have an Approved Label.

PRODUCTS WITH AN APVMA APPROVED LABEL ARE NOT AFFECTED BY THIS NOTICE.

COMPANY DETAILS

Fleamail Pty Ltd ACN 637 942 128

Level 3, 155 Queen Street

Brisbane City QLD 4000

APVMA CONTACT


Director, Compliance and Monitoring


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2304


mailto:[email protected]



SCHEDULE OF PRODUCTS

Product name APVMA approval number

Simparica Chews for Dogs 1.3 – 2.5 kg 80951

Simparica Chews for Dogs 2.6 – 5 kg 80950





Valuheart Monthly Heartworm Tablets for Small Dogs 66289

Valuheart Monthly Heartworm Tablets for Large Dogs 66288

Valuheart Monthly Heartworm Tablets for Medium Dogs 66287

Cazitel Flavoured Allwormer Tablets for Dogs 66818

Cazitel Flavoured Allwormer Tablets for Large Dogs 66816

Revolution for Puppies And Kittens 50867

Revolution for Cats 50881

Revolution Plus (selamectin/sarolaner) monthly topical solution for large cats

5.1 – 10 kg

87222

Revolution Plus (selamectin/sarolaner) monthly topical solution for medium cats

2.6 – 5 kg

87224

Revolution Plus (selamectin/sarolaner) monthly topical solution for small cats

and kittens 1.25 – 2.5 kg

87225

Advocate for Kittens and Small Cats up to 4 kg 55325

Advocate for Cats Over 4 kg 55326


Stop Supply: Ausrichter Pty Ltd (ACN 000 908 529)

Stop Supply: Ausrichter Pty Ltd (ACN 000 908 529)

NOTICE UNDER SECTION 102 OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE SCHEDULED TO

THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994 (CTH) (AGVET CODE) – NO. 24 OF 2020

On 20 November 2020, the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a notice to

Ausrichter Pty Ltd (ACN 000 908 529) (‘the Company’), pursuant to section 102 of the Agvet Code in relation to the

registered chemical product labelled or known as Equisedan Vet 10 mg/ml Solution for injection

(APVMA 61880/10 ml/109), labelled or known as batch 5823-04.

This notice required the Company to immediately stop supply of all stocks of batch 5823-04 of Equisedan Vet 10 mg/ml

Solution for injection; to immediately notify any person who has possession or custody of stocks of batch 5823-04 of

Equisedan Vet 10 mg/ml Solution for injection (either directly or indirectly because of a supply by the Company) that they

must stop supply of stocks of batch 5823-04 of Equisedan Vet 10 mg/ml Solution for injection and return it to the

Company immediately; take all necessary steps to recover all stocks of batch 5823-04 of Equisedan Vet 10 mg/ml

Solution for injection from any person to whom the Company has either directly or indirectly supplied batch 5823-04 of

Equisedan Vet 10 mg/ml Solution for injection; appropriately test any recovered units of batch 5823-04 of the product

Equisedan Vet 10 mg/ml Solution for injection to ensure that they meet the safety, trade and efficacy criteria before

resupply; and quarantine or destroy any defective units of batch 5823-04 of Equisedan Vet 10 mg/ml Solution for

injection in the possession or custody of, or recovered by, the Company.

SUPPLIER DETAILS

Ausrichter Pty Ltd (ACN 000 908 529)

Unit 2/21 Chester Street

Camperdown NSW 2050

APVMA CONTACT


Director, Compliance and Monitoring


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2304 Email: [email protected]

mailto:[email protected]

Agricultural Chemical Products and Approved Labels Veterinary Chemical Products and Approved Labels Approved Active Constituents New Agricultural Active Constituent: Acequinocyl 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 Stop Supply: Fleamail Pty Ltd (ACN 637 942 128) Stop Supply: Ausrichter Pty Ltd (ACN 000 908 529)

apvma gazette no. 24, 1 december 2020...gazette agricultural and veterinary chemicals no. apvma 24,...

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