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Gazette Agricultural andVeterinary Chemicals

No. APVMA 11, Tuesday, 2 June 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 2023

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Australian Pesticides and Veterinary Medicines Authority

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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 11, Tuesday, 2 June 2020 Agricultural and Veterinary Chemicals Code Act 1994

CONTENTS

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

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

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

New veterinary active constituent: itraconazole.....................................................................................................................

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..................................................................

Notice of cancellation at the request of the holder.................................................................................................................


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 NEW ACTIVE CONSTITUENTS

Application no.: 123022

Product name: Campbell Sceptre 230SC Fungicide

Active constituent/s: 230 g/L fludioxonil

Applicant name: Colin Campbell (Chemicals) Pty Ltd

Applicant ACN: 000 045 590

Summary of use: For the control of certain disease of recreational turf

Date of registration: 15 May 2020

Product registration no.:

88955

Label approval no.: 88955/123022


Product name: Campbell Poacure Turf Herbicide

Active constituent/s: 240 g/L methiozolin



Summary of use: For the control of winter grass (Poa annua) in turf



87357



Product name: Surefire Chlorantraniliprole 350 WG Insecticide

Active constituent/s: 350 g/kg chlorantraniliprole

Applicant name: PCT Holdings Pty Ltd


Summary of use: For the control of lepidopteran species of insect pests in cotton and pulse crops



88598



Product name: Trezac Arylex Active Herbicide

Active constituent/s: 30g/L halauxifen present as the methyl ester, 30g/L cloquintocet-mexyl, 25g/L aminopyralid

Applicant name: Dow Agrosciences Australia Limited


Summary of use: For control of broadleaf weeds in winter cereals and fallow, and control of woody weeds in agricultural non-crop areas, commercial and industrial areas, forests, pastures, and rights-of-way



88180




2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Apparent Shaft Herbicide

Active constituent/s: 100 g/L pinoxaden, 25 g/L cloquintocet- mexyl

Applicant name: Titan Ag Pty Ltd


Summary of use: For the control of key grass weeds and selective spray topping of wild oats in wheat and barley



89220



Product name: Imtrade Gallardo 900 WG Fungicide

Active constituent/s: 900 g/kg carbendazim

Applicant name: Imtrade Australia Pty Ltd


Summary of use: For the control of fungal diseases in various crops



87698



Product name: Kelpie Oxy-F 240 Herbicide

Active constituent/s: 240 g/L oxyfluorfen

Applicant name: Sinochem International Australia Pty Ltd


Summary of use: For the selective control of certain broadleaf weeds and some grasses



89064



Product name: Hemani Mancozeb 750 WG Fungicide

Active constituent/s: 750 g/kg mancozeb

Applicant name: Hemani Australia Pty Ltd


Summary of use: For the control of certain fungus diseases of fruit, field crops, tobacco, turf, vegetables and ornamentals



89262





Product name: Farmalinx Brut Herbicide

Active constituent/s: 525 g/L nonanoic acid

Applicant name: Farmalinx Pty Ltd


Summary of use: For non-selective control of seedling and young broadleaf and grass weeds, for suppression of established weeds and perennial species and for control of moss and algae



89257



Product name: Surefire Dimethomorph 500 SC Fungicide

Active constituent/s: 500 g/L dimethomorph

Applicant name: PCT Holdings Pty Ltd


Summary of use: For use on various crops to control various fungicidal diseases when mixed with protectant fungicides



88374



Product name: Apparent Pendimethalin 440 Herbicide

Active constituent/s: 440 g/L pendimethalin



Summary of use: For the control of wireweed, annual grasses (including ryegrass) and certain broadleaved weeds in various crops



89253



Product name: Axiom Gold Plus Fungicide

Active constituent/s: 390 g/kg copper (Cu) present as 600 g/kg copper hydroxide, 50 g/kg metalaxyl-m

Applicant name: Adama Australia Pty Ltd


Summary of use: For the control of various fungal diseases on brassica vegetables, cucumbers, leeks, grapevines, macadamias, potatoes, radishes, swedes, spring onions, turnips and ornamentals



89261





Product name: Gharda Triclopyr 600 EC Herbicide

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

Applicant name: Gharda Australia Pty Ltd


Summary of use: For control of woody weeds and melons in a range of situations



88445



Product name: F.S.A. Terbuthylazine 875 WG Herbicide

Active constituent/s: 875 g/kg terbuthylazine

Applicant name: Four Seasons Agribusiness Pty Ltd


Summary of use: For the control of weeds in chickpeas, faba beans, field peas, lentils, lupins, sorghum and triazine tolerant canola



88546



Product name: The Big Cheese Home Choice Rat & Mouse Killer Ready To Use Bait Station

Active constituent/s: 0.025 g/kg difenacoum

Applicant name: Pelgar International (Aus) Pty Ltd


Summary of use: For control of rats and mice in indoor and outdoor household situations



89203





Product name: The Big Cheese Home Choice Rat Killer Bait Station

Active constituent/s: 0.025 g/kg difenacoum

Applicant name: Pelgar International (Aus) Pty Ltd


Summary of use: For control of rats in indoor and outdoor household situations



89206


3. VARIATIONS OF REGISTRATION


Product name: Final Banquet Mouse Bait

Active constituent/s: 25 g/kg zinc phosphide

Applicant name: Agroserve Pty Ltd


Summary of variation:

To vary the distinguishing product name and the name that appears on the label from ‘Final Feast Mouse Bait’ to ‘Final Banquet Mouse Bait’

Date of variation: 5 May 2020


86877



Product name: Chemron Sentinel Automatically Dispensed Pyrethrum Insecticide Spray

Active constituent/s: 45 g/kg piperonyl butoxide, 9 g/kg pyrethrins

Applicant name: Chemlux Pty Ltd



To vary the distinguishing product name and the name that appears on the label from ‘Cyndan Sentinel Automatically Dispensed Pyrethrum Insecticide’ to ‘Chemron Sentinel Automatically Dispensed Pyrethrum Insecticide Spray’



54165



Product name: Chemron Wasp Eliminator Insecticide

Active constituent/s: 1.3 g/kg d-allethrin, 1.2 g/kg d-phenothrin




To vary the distinguishing product name and the name that appears on the label from ‘Cyndan Wasp Eliminator Insecticide’ to ‘Chemron Wasp Eliminator Insecticide’



60519





Product name: Campbell Absolve Peracetic Acid Biocide

Active constituent/s: 160 g/L peroxyacetic acid, 110 g/L hydrogen peroxide




To vary the distinguishing product name and the name that appears on the label from ‘Campbell Perasan Peracetic Acid Biocide’ to ‘Campbell Absolve Peracetic Acid Biocide’



87664



Product name: Chemron Algae-Died 'B' For Killing Algae And Black Spot

Active constituent/s: 142.5 g/L quaternary ammonium compound




To vary the distinguishing product name and the name that appears on the label from ‘Cyndan Algae-Died 'B' For Killing Algae And Black Spot’ to ‘Chemron Algae-Died 'B' For Killing Algae And Black Spot’ and to add pack sizes



47349



Product name: Bushman Plus Personal Insect Repellent Pump Spray

Active constituent/s: 200g/L diethyltoluamide, 11g/L N-octyl bicycloheptene dicarboximide

Applicant name: Juno Limited

Applicant ACN: N/A


Remove di-n-propyl isocinchomeronate from the ingredients in the formulation



69463



Product name: Conquest Glisarin 704 Spray Adjuvant

Active constituent/s: 704 g/L ethyl and methyl esters of canola oil fatty acids

Applicant name: Conquest Crop Protection Pty Ltd



To include additional use patterns



61791





Product name: Eezi Pool Shock Treatment

Active constituent/s: 650 g/kg chlorine (Cl) present as calcium hypochlorite

Applicant name: Eezi Pool Australia Pty Ltd



To change the name from ‘Eezi Pool Eezi Pool Shock Treatment’ to ‘Eezi Pool Shock Treatment’



85069



Product name: Chemron Glyphocyde 450 Weedkiller

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




To vary the distinguishing product name and the name that appears on the label from ‘Cyndan Glyphocyde 450 Weedkiller’ to ‘Chemron Glyphocyde 450 Weedkiller’ and to add pack sizes



46086



Product name: Hy-Clor Super-Shock Granular Pool Chlorine

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

Applicant name: Hy-Clor (Australia) Pty Ltd



To vary the name that appears on the label from ‘Swimgo Shock Treatment’ to ‘Swim ABC Shock Treatment’



56110



Product name: Hy-Clor Long Lasting Swimming Pool Tablets

Active constituent/s: 850 g/kg available chlorine (Cl) present as trichloroisocyanuric acid




To vary the name that appears on the label from ‘Swimgo Multi Tablets’ to ‘Swim ABC Multi Tablets’



56112





Product name: Hy-Clor Long Lasting Swimming Pool Tablets

Active constituent/s: 850 g/kg available chlorine (Cl) present as trichloroisocyanuric acid




To vary the name that appears on the label from ‘Swimgo Long Lasting Swimming Pool Tablets’ to ‘Swim ABC Long Lasting Swimming Pool Tablets’



56112



Product name: Hy-Clor Granular Pool Chlorine

Active constituent/s: 650 g/kg available chlorine (Cl) present as calcium hypochlorite




To vary the name that appears on the label from ‘Swimgo Granular Chlorine’ to ‘Swim ABC Granular Chlorine’



56157



Product name: Hy-Clor Liquid Chlorine

Active constituent/s: 125 g/L available chlorine (Cl) present as sodium hypochlorite




To vary the name that appears on the label from ‘Swimgo Liquid Chlorine’ to ‘Swim ABC Liquid Chlorine’



66166



Product name: Hy-Clor Algaecide

Active constituent/s: 150 g/L benzalkonium chloride




To vary the name that appears on the label from ‘Swimgo Algaecide’ to ‘Swim ABC Algaecide’



66276





Product name: Hy-Clor 3 In 1 Concentrated Pool Chlorine

Active constituent/s: 560 g/kg chlorine (Cl) present as sodium dichloroisocyanurate dihydrate




To vary the name that appears on the label from ‘Swimgo 3 In 1 Granular Pool Chlorine’ to ‘Swim ABC 3 In 1 Granular Pool Chlorine’



66084



Product name: Titan Methomyl 225 Insecticide

Active constituent/s: 593 g/L methanol, 225 g/L methomyl




To add use in lettuce



69047



Product name: Combat Roach-Rid Roach Killing Bait Strips

Active constituent/s: 0.1 g/kg fipronil

Applicant name: Henkel Australia Pty Ltd



To vary the distinguishing product name and the name that appears on the label from ‘Combat Roach Killing Bait Strips’ to ‘Combat Roach-Rid Roach Killing Bait Strips’



70308



Product name: Gardenline Weed Terminator RTU

Active constituent/s: 90 g/L acetic acid

Applicant name: Amgrow Pty Ltd



To vary the distinguishing product name and the name that appears on the label from ‘Gardenline Weed Terminator’ to ‘Gardenline Weed Terminator RTU’



88254





Product name: Suspectin 18EC Insecticide/Miticide

Active constituent/s: 18 g/L abamectin

Applicant name: Ruralco Holdings Limited



To add use in lettuce, snow peas, sugar snap peas, cultivated mushrooms, citrus trees, rhubarb, duboisia, raspberry, blackberry, blackcurrant, papaya (pawpaw), blueberries, sweet corn, chillies, paprika, spring onions and shallots, avocadoes, passionfruit, capsicum, cucumber, eggplant, zucchini, tomato, citrus, mung bean, adzuki bean, navy bean, tea tree oil, custard apples, nursery stock, cut flowers and litchi as part of the permit to label project



83210



Product name: Bollgard 3

Active constituent/s: Bacillus thuringiensis subsp. kurstaki delta endotoxins as produced by the Cry1Ac and Cry2Ab genes and their controlling sequences, bacillus thuringiensis strain AB88 exotoxin as produced by the Vip3A(a) gene and its controlling sequence

Applicant name: Monsanto Australia Pty Ltd



To vary the conditions of registration and associate resistance management plans



69656



Product name: 4Farmers Prosulfocarb Herbicide

Active constituent/s: 800 g/L prosulfocarb

Applicant name: 4 Farmers Australia Pty Ltd



To include early post-emergence application for the control of annual ryegrass in wheat and barley



82536



Product name: Accensi Abamectin Insecticide


Applicant name: Accensi Pty Ltd






53080





Product name: Combat Ant-Rid Indoor Ant Liquid Relief From Tough Ant Problems

Active constituent/s: 11.83 g/L boron (B) present as 104.4 g/l borax decahydrate

Applicant name: Henkel Australia Pty Ltd



To vary the distinguishing product name and the name that appears on the label from ‘Combat Ant-Rid Relief From Tough Ant Problems Indoor Ant Liquid’ to ‘Combat Ant-Rid Indoor Ant Liquid Relief From Tough Ant Problems’. To vary the instructions for storage and disposal of containers or products, in line with the relevant requirements for the type of container as specified in the Agricultural Labelling Code made by the APVMA



50920



Product name: Bushman Repellent Plus Personal Insect Repellent

Active constituent/s: 200 g/kg diethyltoluamide, 11 g/kg N-octyl bicycloheptene dicarboximide

Applicant name: Juno Limited

Applicant ACN: N/A


Remove di-n-propyl isocinchomeronate from the ingredients in the formulation



47106



Product name: Boxer Gold Herbicide

Active constituent/s: 800 g/L prosulfocarb, 120 g/L S-metolachlor

Applicant name: Syngenta Australia Pty Ltd



To include a new early post-emergent rate in wheat and barley



61234



Product name: Barmac Abamectin Insecticide


Applicant name: Amgrow Pty Ltd






83173





Product name: Roundup Ultra Max Herbicide

Active constituent/s: 570 g/L glyphosate present as the potassium salt

Applicant name: Monsanto Australia Pty Ltd



To add pre-harvest use in barley as a harvest aid and weed control



68506



Product name: Kenso Agcare Indy 150 OD Insecticide

Active constituent/s: 200 g/L indoxacarb (3:1), sufficient to give 150 g/L of the active S-indoxacarb isomer

Applicant name: Kenso Corporation (M) Sdn Bhd

Applicant ACN: N/A


To include control of lepidopteran species of insect pests in certain vegetable crops



88131



Product name: Campbell Fludy 230SC Fungicide





To add the following use instructions: suppression of surface moulds and fungal rots in chestnuts; and post-harvest moulds in pineapple to product containing 230 g/L fludioxonil



83843



Product name: Vivus Armigen Helicoverpa Biocontrol

Active constituent/s: 7.5 x 109 polyhedral inclusion bodies of the nucleopolyhedrovirus of Helicoverpa armigera per millilitre

Applicant name: AgBiTech Pty Ltd



To change the product name from ‘Armigen Helicoverpa Biocontrol’ to ‘Vivus Armigen Helicoverpa Biocontrol’



70336





Product name: Starling Fungicide


Applicant name: Grochem Australia Pty Ltd



To add suppression of surface moulds and fungal rots in chestnuts; and post-harvest moulds in pineapple as part of the permit to label project



84680



Product name: Genfarm Diclofop-Methyl 375 Selective Herbicide

Active constituent/s: 375 g/L diclofop-methyl

Applicant name: Nutrien Ag Solutions Limited



To add an additional formulation



59527


4. VARIATION OF LABEL APPROVAL


Product name: Hyclor Long Life Algaecide

Active constituent/s: 40 g/L copper (Cu) present as a cupric ammonium complex




To vary the name that appears on the label from ‘Swimgo Long Life Algaecide’ to ‘Swim ABC Long Life Algaecide’



59579



Product name: Farmalinx Oat Master Herbicide

Active constituent/s: 90 g/L flamprop-m-methyl

Applicant name: Farmalinx Pty Ltd



To increase the application growth stage window for desi variety chickpeas



69871




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 NEW ACTIVE CONSTITUENTS


Product name: FelineGuard FeLV

Active constituent/s: Each 1 mL dose contains inactivated feline leukaemia virus (FeLV) subtypes A, B and C (Kawakami-Theilen strain) including gp70 sub-unit antigen

Applicant name: Zoetis Australia Pty Ltd


Summary of use: Registration of a 218.4 ug/m L inactivated feline leukaemia virus subtypes A, B and C (Kawakami-Theilen strain) and gp70 sub-unit antigen product to protect susceptible cats against persistent feline leukaemia virus (FeLV) infection and associated clinical disease



80322


2. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Multitrace Injection For Cattle

Active constituent/s: 40 g/L zinc as disodium zinc EDTA, 15 g/L copper as disodium copper EDTA, 10 g/L manganese as disodium manganese EDTA, 5 g/L selenium as sodium selenite

Applicant name: Intervet Australia Pty Ltd


Summary of use: For the registration of an injectable solution for use in cattle deficient in and/or responsive to manganese, zinc, selenium and/or copper supplementation



89168



Product name: Imperial Pour-On Fly And Lice Treatment For Cattle And Horses

Active constituent/s: 15 g/L deltamethrin

Applicant name: WSD Agribusiness Pty Ltd


Summary of use: For control of stable fly (Stomoxys calcitrans), house fly (Musca domestica), and lice (Bovicola bovis, Linognathus vituli and Haematopinus eurysternus) and synthetic pyrethroid susceptible buffalo fly (Haematobia irritans exigua) on beef and dairy cattle. For control of synthetic pyrethroid susceptible buffalo fly (Haematobia irritans exigua) for up to 3 weeks and for control of stable fly (Stomoxys calcitrans) for up to 1 week on horses. Provides protection from Culicoides brevitarsus for at least 14 days with effective control of blood feeding C.brevitarsus for 6 days post treatment



89229




3. VARIATIONS OF REGISTRATION


Product name: Gleptosil Iron Injection

Active constituent/s: 463 mg/mL gleptoferron equivalent to elemental iron 200 mg/mL

Applicant name: Ceva Animal Health Pty Ltd



To vary the product registration and label approval to add a new pack size, packaging and to update the shelf life and storage conditions



52474



Product name: Pastoral Ag Iverlab Blowfly And Lice Jetting Fluid For Sheep

Active constituent/s: 16 g/L ivermectin

Applicant name: The Hunter River Company Pty Ltd



To vary the distinguishing product name and the name that appears on the label from ‘Pastoral Ag Ivermectin Blowfly and Lice Jetting Fluid For Sheep’ to ‘Pastoral Ag Iverlab Blowfly And Lice Jetting Fluid For Sheep’



88811



Product name: Pastoral Ag Eprinolab Pour-On For Beef And Dairy Cattle

Active constituent/s: 5 mg/mL eprinomectin




To vary the distinguishing product name and the name that appears on the label from ‘Pastoral Ag Eprinomectin Pour-On For Beef And Dairy Cattle’ to ‘Pastoral Ag Eprinolab Pour-On For Beef And Dairy Cattle’



88823



Product name: Pastoral Ag Iverlab LV Pour-On For Cattle

Active constituent/s: 10 g/L ivermectin




To vary the distinguishing product name and the name that appears on the label from ‘Pastoral Ag Ivermectin LV Pour-On For Cattle’ to ‘Pastoral Ag Iverlab LV Pour-On For Cattle’



88831





Product name: Websters 5 In 1 Se Vaccine

Active constituent/s: 5.0 IU/mL clostridium perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. tetani, 2.5 IU/mL Cl. septicum, ≥ 0.15% pcv/mL Cl. chauvoei, 0.5mg/mL selenium as sodium selenate

Applicant name: Virbac (Australia) Pty Ltd



To vary the product registration and label approval to update relevant particulars



47952



Product name: Cydectin Weanerguard SE B12 6 In 1 Vaccine And Wormer With Selenium And Vitamin B12 For Sheep

Active constituent/s: 5.0 IU/mL Cl. perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. septicum, 2.5 mg/mL moxidectin, 2.5 IU/mL Cl. tetani, 1.0 mg/mL vitamin B12 (hydroxocobalamin acetate), 1.0 U/mL C. pseudotuberculosis (ovis), ≥ 0.15% pcv/mL Cl. chauvoei, 0.5 mg/mL selenium as sodium selenate




Variation of product registration and label approval to update relevant particulars



59350



Product name: Cydectin Eweguard SE B12 6 In 1 Vaccine And Wormer With Selenium And Vitamin B12 For Sheep

Active constituent/s: 5.0 mg/mL moxidectin, 5.0 IU/mL Cl. perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. septicum, 2.5 IU/mL Cl. tetani, 1.0 U/mL C. pseudotuberculosis (ovis),1 mg/mL vitamin B12 (hydroxocobalamin acetate), ≥ 0.15% pcv/mL Cl. chauvoei, 1.0 mg/mL selenium as sodium selenate







58527



Product name: Cydectin Eweguard 6 In 1 Vaccine And Wormer For Sheep

Active constituent/s: 5.0 g/L moxidectin, 5.0 IU/mL Cl. perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. septicum, 2.5 IU/mL Cl. tetani, 1.0 U/mL C. pseudotuberculosis (ovis), ≥ 0.15% pcv/mL Cl. chauvoei







47607





Product name: Cydectin Weanerguard 6 In 1 Vaccine And Wormer For Sheep

Active constituent/s: 5.0 IU/mL Cl. perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 g/L moxidectin, 2.5 IU/mL Cl. septicum, 2.5 IU/mL Cl. tetani, 1.0 U/mL c. pseudotuberculosis (ovis), ≥ 0.15% pcv/mL Cl. chauvoei







47608



Product name: NV Pentosan Gold Injection For Horses

Active constituent/s: 200 mg/mL acetyl glucosamine, 125 mg/mL pentosan polysulfate sodium

Applicant name: Ceva Animal Health Pty Ltd



To add an additional 50 mL pack size to the registered product NV Pentosan Gold Injection For Horses



63195



Product name: Coopers Cattlevax LC 7 In 1 Leptospiral And Clostridial Vaccine For Beef, Dairy Cattle And Calves

Active constituent/s: 5.0 IU/mL Clostridium perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. septicum, 2.5 IU/mL Cl. tetani, 0.5 x 109 org/mL Leptospira interrogans serovar Hardjo, 0.5 x 109 org/mL Leptospira interrogans serovar pomona, ≥ 0.15% pcv/mL Cl. chauvoei

Applicant name: Intervet Australia Pty Ltd






53206



Product name: Allfarm Piperazine Wormer For Poultry

Active constituent/s: 530 mg/g piperazine as piperazine dihydrochloride

Applicant name: Parafarm Pty Ltd



To update the label particulars by addition of a new pack size



45124




4. LABEL APPROVAL


Product name: Ilium Meloxicam Anti-Inflammatory Oral Suspension For Dogs

Active constituent/s: 1.5 mg/mL meloxicam

Applicant name: Troy Laboratories Pty Ltd



To update label



60023




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:

Meloxicam

Applicant name: South Yarra Pharma Pty Ltd


Summary of use: For use in veterinary chemical products

Date of approval: 12 May 2020

Approval no.: 88953



Oxytetracycline dihydrate

Applicant name: South Yarra Pharma Pty Ltd


Summary of use: For use in veterinary chemical products


Approval no.: 88961



Methiozolin



Summary of use: For use in agricultural chemical products


Approval no.: 87356



Pinoxaden

Applicant name: Foison Scitech Co Limited

Applicant ACN: N/A



Approval no.: 88716



Clethodim

Applicant name: Sinochem Agro Co Ltd

Applicant ACN: N/A



Approval no.: 88720



2. VARIATIONS OF ACTIVE CONSTITUENT



Chlorpheniramine maleate

Applicant name: Jurox Pty Ltd



Variation of relevant particulars or conditions of an approved active constituent


Approval no.: 54859



Morantel citrate monohydrate




Variation of relevant particulars or conditions of an approved active constituent


Approval no.: 83043



New veterinary active constituent: itraconazole

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new veterinary active constituent, itraconazole, for use in the treatment of fungal infections in companion animals.

Common name: Itraconazole

IUPAC name: 1-((2RS)-Butan-2-yl)-4-{4-[4-(4-{[(2RS,4SR)-2-(2,4-dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one

Chemical abstracts name: rel-4-[4-[4-[4[[(2R,4S)2-(2, 4-Dichlorophenyl)-2-(1H-1, 2,4-triazol-1-ylmethyl)-1, 3-dioxolan-4-yl] methoxy] phenyl]-1-piperazinyl]phenyl]-2, 4-dihydro-2-(1-methylpropyl)-3H-1,2, 4-triazol-3-one

CAS number: 84625-61-6

Molecular formula: C35H38Cl2N8O4

Molecular weight: 705.64 g/mol

Structure:

Chemical family: Synthetic triazole compound

Mode of action: Inhibition of cytochrome P450 enzymes and decreasing fungal ergosterol synthesis and/or affecting their metabolism

SUMMARY OF THE APVMA’S EVALUATION

The APVMA has evaluated the chemistry aspects of itraconazole active constituent (identification, physicochemical properties, manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.

Itraconazole will be manufactured to the standard of the British Pharmacopoeia monograph.

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

The APVMA has considered the toxicological aspects of itraconazole, and concluded that there are no toxicological concerns to the approval of this active constituent. As there are currently no proposed uses in food producing animals, neither an Acceptable Daily Intake (ADI) nor an Acute Reference Dose (ARfD) has been established.

As a result of its use in human pharmaceuticals, itraconazole is already included in Schedule 4 of the Poison Standard, and this listing remains appropriate.

The APVMA is satisfied that the proposed importation and use of itraconazole 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 itraconazole should be granted. Submissions should relate only to matters that are considered in determining whether the safety criteria set out in section 5A of the Agvet Code have been met. Submissions should state the grounds on which they are based.

Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

When making a submission please include a:

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

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

Written submissions should be addressed in writing to:

Director of Chemistry and ManufactureRisk Assessment CapabilityAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001

Phone: +61 2 6770 2300Email: [email protected]

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


mailto:[email protected]


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) 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 Australian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001




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 25 of APVMA Gazette No. 11, 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) 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 (19 May 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] inserting in alphabetical order

Agvet chemical: aclonifen

Permitted residue: aclonifenBarley T*0.01Edible offal (mammalian) T*0.01Eggs T*0.01Meat (mammalian) T*0.01Milks T*0.01Poultry meat T*0.01Poultry, edible offal of T*0.01Triticale T*0.01Wheat T*0.01

Agvet chemical: metcamifen

Permitted residue—commodities of plant origin: metcamifenPermitted residue—commodities of animal origin: sum of metcamifen and 4-(3-methyl-ureido)-benzensulfonamide, expressed as metcamifenEdible offal (mammalian) *0.03Eggs *0.03Meat (mammalian) *0.03Milks *0.03Poultry, edible offal of *0.03Poultry meat *0.03Sorghum *0.01

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

Agvet chemical: azoxystrobin

Permitted residue: azoxystrobin

Rye 0.1Triticale 0.1



Agvet chemical: chlorantraniliprole

Permitted residue—plant commodities and animal commodities other than milk: chlorantraniliprolePermitted residue—milk: sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliproleMaize cereals T*0.01Sugar cane T0.5

Agvet chemical: cyproconazole

Permitted residue: cyproconazole, sum of isomersOats 0.05Rye *0.02Triticale *0.02

Agvet chemical: emamectin

Permitted residue: sum of emamectin B1a and emamectin B1bMaize cereals T*0.01Wheat, similar grains, and pseudocereals without husks

T*0.01

Agvet chemical: etoxazole

Permitted residue: etoxazole

Cane berries T0.5

Agvet chemical: flonicamid

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

Blackberries T2Bulb vegetables T0.2Raspberries, red, black T2

Agvet chemical: fludioxonil

Permitted residue—commodities of animal origin: sum of fludioxonil and oxidisable metabolites, expressed as fludioxonilPermitted residue—commodities of plant origin: fludioxonil

Eggs T*0.01Poultry meat T*0.01Poultry, edible offal of T*0.01



Pulses T0.1

Agvet chemical: indoxacarb

Permitted residue: sum of indoxacarb and its R-isomerMaize cereals T*0.01Peppers 0.5

Agvet chemical: linuron

Permitted residue: sum of linuron plus 3,4-dichloroaniline, expressed as linuronCoriander (leaves, roots, stems) T1

Agvet chemical: napropamide

Permitted residue: napropamideAll other foods except animal food commodities

0.02

Agvet chemical: novaluron

Permitted residue: novaluron

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

0.3

Fruiting vegetables, other than cucurbits 0.2Leafy vegetables 5

Agvet chemical: permethrin

Permitted residue: permethrin, sum of isomersPoppy seed T0.2

Agvet chemical: prothioconazole

Permitted residue—commodities of plant origin: sum of prothioconazole and prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazolePermitted residue—commodities of animal origin: sum of prothioconazole, prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-3-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol) and prothioconazole-4-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-4-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazoleWatermelon T0.2



Agvet chemical: pyridate

Permitted residue: sum of pyridate and metabolites containing 6 chloro-4-hydroxyl-3-phenyl pyridazine, expressed as pyridate

Chick-pea (dry) *0.05

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


Permitted residue: sum of indoxacarb and its R-isomer

Peppers, sweet [capsicum] 0.5

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

Agvet chemical: etoxazole

Permitted residue: etoxazoleAvocado T0.05

Agvet chemical: fludioxonilPermitted residue—commodities of animal origin: sum of fludioxonil and oxidisable metabolites, expressed as fludioxonilPermitted residue—commodities of plant origin: fludioxonilRape seed (canola) T0.2

Agvet chemical: glufosinate and glufosinate-ammoniumPermitted residue: sum of glufosinate-ammonium, N-acetyl glufosinate and 3-[hydroxy(methyl)-phosphinoyl] propionic acid, expressed as glufosinate (free acid)Rape seed (canola) 0.5

Agvet chemical: glyphosate

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

Barley 20



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) 30 June 2020.

SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL ONLY BE CONSIDERED BY PRIOR ARRANGEMENT

Submissions received after this date will only be considered if agreement for an extension has been given prior to this closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to the submission period.


MRL Contact Officer Australian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney 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. 2) gazetted on 10 March 2020 (No. APVMA 5).

Submissions have been sought on these proposals and the APVMA has written separately to each person or organisation that made a submission. All matters raised in the submissions have been resolved.

Under subsection 82(1) of the Food Standards Australia New Zealand Act 1991, the APVMA has, by legislative instrument, incorporated these variations to MRLs into Schedule 20. A copy of the Amendment Instrument (No. APVMA 4, 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.

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 OfficerAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney 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 4, 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 LutzeDelegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority

Dated this Twenty sixth day of May 2020



Part 1 Preliminary1 Name of instrument

This instrument is the Australia New Zealand Food Standards Code–Schedule 20maximum residue limits Variation Instrument No. APVMA 4, 2020.

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 20Maximum residue limits in the Australia New Zealand Food Standard Code as defined in Section 4 of the Food Standards Australia New Zealand Act 1991 being the Code published in Gazette No. P 27 on 27 August 1987 together with any amendments of the standards in that Code. Schedule 20 was published in the Food Standards Gazette FSC 96 on Thursday 10 April 2015 and was registered as a legislative instrument on 1 April 2015 (F2015L00468).

Part 2 Variations to Schedule 20–Maximum Residue Limits

5 Variations to Schedule 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: paracetamol

Permitted residue: paracetamolPig fat/skin *0.1Pig kidney *0.1Pig liver *0.1Pig muscle *0.1

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

Agvet chemical: bupirimate

Permitted residue: bupirimate

Tomato T1

Agvet chemical: cyanamide

Permitted residue: cyanamide

Almonds *0.01

Agvet chemical: cyazofamid

Permitted residue: cyazofamidAll other foods except animal food commodities

0.04

Poppy seed T*0.01

Agvet chemical: diafenthiuron

Permitted residue: sum of diafenthiuron; N-[2,6-bis(1-methylethyl)-4-phenoxyphenyl]-N′-(1,1-dimethylethyl)urea; and N-[2,6-bis(1-methylethyl)-4-phenoxyphenyl]- N′-(1,1-dimethylethyl)carbodiimide, expressed as diafenthiuron

Peanut T0.3Soya bean (dry) T0.3

Agvet chemical: fludioxonil

Permitted residue: commodities of animal origin: Sum of fludioxonil and oxidisable metabolites, expressed as fludioxonilPermitted residue—commodities of plant origin: fludioxonilPapaya T5



Agvet chemical: fluopicolide

Permitted residue: fluopicolide

Basil T30


Permitted residue: sum of indoxacarb and its R-isomer

Walnuts T0.02

Agvet chemical: metolachlor

Permitted residue: metolachlorPulses [except soya beans (dry); adzuki beans (dry)]

*0.01

Agvet chemical: propamocarb

Permitted residue: propamocarb (base)Basil T150

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

Agvet chemical: cyanamide

Permitted residue: cyanamide

Walnuts *0.02

Agvet chemical: fluopicolide

Permitted residue: fluopicolideBrassica (cole or cabage) vegetables, head cabbages, flowerhead brassicas

5

Agvet chemical: linuron

Permitted residue: permitted residue: sum of linuron plus 3,4-dichloroaniline, expressed as linuron

Celeriac T3

Agvet chemical: metolachlor

Permitted residue: metolachlor

Mung bean (dry) T*0.05Pulses [except adzuki bean (dry); mung bean (dry); soya bean (dry)]

*0.01

Agvet chemical: propamocarb

Permitted residue: propamocarb (base)Leafy vegetables 70



Notice of cancellation at the request of the holder

At the request of the holder, in accordance with section 42(1) of the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code), the Australian Pesticides and Veterinary Medicines Authority (APVMA) has cancelled the approvals and/or registrations set out in the table below.

Approval or registration N=number

Name Type of approval or registration

Holder Date of cancellation

44220 Phenylmercury acetate manufacturing concentrate

Active constituent Alpha Chemicals Pty Ltd

26 May 2020

44221 Methoxyethylmercuric acetate manufacturing concentrate


26 May 2020

44222 Methoxyethylmercuric chloride manufacturing concentrate


26 May 2020

44223 Methoxyethylmercuric chloride manufacturing concentrate


26 May 2020

In accordance with section 45A(1)(b) of the Agvet Code, the APVMA publishes this notice of the cancellation, including the following reasons, instructions, and warnings which set out how a person can deal with the cancelled active constituent, cancelled product or product bearing a cancelled label referred to in the above table.

BRIEF REASONS

Pursuant to section 42(1)(b) of the Agvet Code, the APVMA was satisfied that there are no valid reasons why the APVMA should not agree to the request of the holder to cancel the approvals and/or registrations set out in the above table.

INSTRUCTIONS FOR PERSONS WHO POSSESS, HAVE CUSTODY OF OR USE THE CANCELLED ACTIVE CONSTITUENT, CANCELLED PRODUCT, OR THE PRODUCT BEARING A CANCELLED LABEL UNDER SECTION 45A(2)OF THE AGVET CODE

A person who possesses, has custody of or uses the cancelled active constituent, cancelled product or product bearing a cancelled label referred to in the above table in accordance with the instructions contained in this notice, is taken to have been issued with a permit under section 45B(3) of the Agvet Code to possess, have custody of or use the cancelled active constituent, cancelled product or product bearing a cancelled label, in accordance with those instructions.

POSSESSION OR CUSTODY

A person may possess the cancelled active constituent, cancelled product or product bearing a cancelled label referred to in the above table in accordance with its label instructions for 12 months from the date of cancellation.



USE, SUPPLY OR OTHERWISE DEAL WITH

A person may use the cancelled active constituent, cancelled product or products bearing a cancelled label referred to in the above table according to its label instructions, including any conditions relating to shelf life or expiry date, for 12 months after the date of cancellation.

A person may supply or cause to be supplied at wholesale or retail level the cancelled active constituent, cancelled product, or product bearing a cancelled label referred to in the above table, for 12 months after the date of cancellation.

WARNING - CONTRAVENTIONS

After the day that is 12 months from the date of cancellation it will be an offence against the Agvet Code to have possession or custody of the cancelled active constituents, cancelled products or products bearing a cancelled label with the intention to supply, or to supply the cancelled active constituent, cancelled product, or product bearing a cancelled label.

It is an offence to possess, have custody of, use, or otherwise deal with the cancelled active constituents, cancelled products or products bearing the cancelled label listed in the table above in a manner that contravenes the above instructions.

APVMA CONTACT

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

Chemical ReviewAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001

Phone: +61 2 6770 2400

Email: [email protected]



apvma gazette no. 11, 2 june 2020 · web viewcommonwealth of australia gazette no. apvma 11,...

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