apvma gazette no. 05, 10 march 2020 · commonwealth of australia gazette no. apvma 5, tuesday, 10...

Gazette

Agricultural and

Veterinary Chemicals

No. APVMA 5, Tuesday, 10 March 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.

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Commonwealth of Australia Gazette No. APVMA 5, Tuesday, 10 March 2020 Agricultural and Veterinary Chemicals Code Act 1994 3

CONTENTS

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

Veterinary Chemical Products and Approved Labels .................................................................................................... 17

Approved Active Constituents ....................................................................................................................................... 23

New agricultural active constituent: methiozolin ............................................................................................................ 25

New chemical product: Campbell Poacure Turf Herbicide containing methiozolin ........................................................ 27

New agricultural active constituent: tetraniliprole .......................................................................................................... 30

New chemical product: Vayego 200 SC Insecticide containing tetraniliprole ................................................................ 32

Amendments to the APVMA MRL Standard .................................................................................................................. 35

Proposal to amend Schedule 20 in the Australia New Zealand Food Standards Code ................................................. 36

Variations to Schedule 20 of the Australia New Zealand Food Standards Code ........................................................... 40

Notice of cancellation at the request of the holder ........................................................................................................ 44

Pesticide and veterinary medicines product sales 2018–19 financial year .................................................................... 47


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.: 122716

Product name: Farmalinx Sumo Selective Herbicide

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

Applicant name: Farmalinx Pty Ltd

Applicant ACN: 134 353 245

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

Date of registration: 17 February 2020

Product registration no.: 88876

Label approval no.: 88876/122716


Product name: JSAL Halosulfuron 750 WG Herbicide

Active constituent/s: 750 g/kg halosulfuron-methyl

Applicant name: Jiangsu Agrochem Laboratory Co Ltd

Applicant ACN: N/A

Summary of use: For selective post-emergence control of nutgrass in sugarcane, corn/maize and sorghum and for the selective post-emergence control of nutgrass and Mullumbimby couch in turf. Also for the control of nutgrass in cotton using shielded sprayers





Product name: Vitalyse Stabilised Multi Action Chlorine Tablets

Active constituent/s: 900 g/kg available chlorine (Cl) present as trichloroisocyanuric acid, 7.5 g/kg copper present as copper sulfate pentahydrate

Applicant name: Focus Products Pty Ltd


Summary of use: For the control of algae and bacteria in outdoor swimming pools





Product name: Fantastic Full 200 Herbicide

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

Applicant name: Sunrise Crop Science Co Ltd

Applicant ACN: N/A

Summary of use: For non-residual control of broadleaf and grass weeds in various situations







Product name: Epoxikey Fungicide

Active constituent/s: 125 g/L epoxiconazole

Applicant name: Industrial Quimica Key S A

Applicant ACN: N/A

Summary of use: For the control of leaf rust, stripe rust and Septoria nodorum blotch of wheat and leaf rust of barley





Product name: Exitox Miticide

Active constituent/s: 100 g/L hexythiazox


Applicant ACN: N/A

Summary of use: For the control of two-spotted mite (Tetranychus urticae) and European red mite (Panonychus ulmi) on apples, pears, stone fruit, and ornamentals and for control of two-spotted mite on strawberries





Product name: EuroChem Buffer 700 Surfactant

Active constituent/s: 350 g/L propionic acid, 350 g/L soyal phospholipids

Applicant name: Eurochem Pty Ltd


Summary of use: For acidifying and penetrating surfactant, reduces alkaline hydrolysis of dimethoate, assists with uptake of foliar fertilisers, assists in management of spray droplet size





Product name: Titan Fluazifop 212 Post-Emergence Selective Herbicide

Active constituent/s: 212 g/L fluazifop-p present as the butyl ester

Applicant name: Titan Ag Pty Ltd


Summary of use: For the control of certain grasses in crops





Product name: Flukey Fungicide

Active constituent/s: 250 g/L flutriafol


Applicant ACN: N/A

Summary of use: For the control of certain fungal diseases on wheat, barley and canola when mixed with fertiliser or applied as a foliar spray







Product name: Halo-Force 750 WG Herbicide

Active constituent/s: 750 g/kg halosulfuron-methyl

Applicant name: EnviroMint Ltd

Applicant ACN: N/A

Summary of use: For selective post-emergence control of nutgrass in sugarcane, corn/maize and sorghum and for the selective post-emergence control of nutgrass and Mullumbimby couch in turf. Also for the control of nutgrass in cotton using shielded sprayers





Product name: Pyrate Natural Insecticide

Active constituent/s: 160 g/L piperonyl butoxide, 40 g/L pyrethrins

Applicant name: Freezone Public Health Pty Ltd


Summary of use: For the control of a wide range of insects including insect pests of household and agricultural situations





Product name: Opal Penetrating Spray Adjuvant

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

Applicant name: Opal Australasia Pty Ltd


Summary of use: For assisting the effectiveness of herbicides and other agricultural chemicals





Product name: Apparent Azoxystrobin Extra Fungicide

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



Summary of use: For control of certain fungal diseases in barley, wheat and peanuts





Product name: Farmalinx DSMA 100 Herbicide

Active constituent/s: 100 g/L DSMA



Summary of use: For the control of certain broadleaf weeds and grasses in sports turf and lawn







Product name: Titan Bifenthrin 250 EC Insecticide

Active constituent/s: 250 g/L bifenthrin



Summary of use: For control of insect pests and mites of apricots, bananas, barley, canola, citrus, clover, cotton, faba beans, field peas, grapes, lucerne, lucerne seed crops, lupins, navy beans, nectarines, peaches, pears, plums, subterranean clover, sugarcane, tomatoes and wheat





Product name: Atlas Enviroshield 2 In 1 Automatic Insect Control System

Active constituent/s: 6 g/kg natural pyrethrins, 60 g/kg piperonyl butoxide

Applicant name: Pascoe's Pty Ltd


Summary of use: For use in the home and garden to repel flies and other insects





Product name: Surefire Trepidex 500 Insecticide

Active constituent/s: 500 g/L trichlorfon

Applicant name: PCT Holdings Pty Ltd


Summary of use: For the control of a wide variety of insect pests in various agricultural situations





Product name: 4Farmers Bifenthrin 300 EC Insecticide

Active constituent/s: 300 g/L bifenthrin

Applicant name: 4 Farmers Australia Pty Ltd


Summary of use: For the control of Helicoverpa spp. in cotton, tomatoes, lucerne seed crops, navy beans; certain species of mites in bananas, cotton and tomatoes; longtailed mealy bug in pears; banana weevil borer and banana rust thrips in bananas; mirids in cotton; whitefly in tomatoes; redlegged earth mite, blue oat mite, bryobia mite, webworm and brown pasture looper in faba beans, subterranean clover, clover, canola, wheat, barley, field peas, lupins and lucerne; and certain species of wireworms in cotton and sugarcane; fig longicorn in grapes and citrus leaf eating weevil in citrus







Product name: NAADCO Trifluralin 480 Herbicide

Active constituent/s: 480 g/L trifluralin

Applicant name: New Australia Agricultural Development Company Pty Ltd


Summary of use: For control of annual grasses and certain broadleaf weeds in certain horticultural and agricultural crops





Product name: AC Dizzy 800 Insecticide

Active constituent/s: 800 g/L diazinon

Applicant name: AxiChem Pty Ltd


Summary of use: For the control of many insect pests in fruit and vegetable crops, field crops, turf and various domestic, commercial and industrial areas





Product name: Kenso Agcare Mepiquat Xtra 250 Plant Growth Regulator

Active constituent/s: 250 g/L mepiquat present as the chloride salt

Applicant name: Kenso Corporation (m) Sdn Bhd

Applicant ACN: N/A

Summary of use: For the management of fruiting and vegetative growth in cotton





Product name: Anhui Guangxin Hexazinone Diuron 600 WG Herbicide

Active constituent/s: 468 g/kg diuron, 132 g/kg hexazinone

Applicant name: Anhui Guangxin Agrochemical Co Ltd

Applicant ACN: N/A

Summary of use: For the control of a wide range of annual and perennial grasses, broad leaf weeds, and vines in established sugarcane





Product name: Sabakem Propyzamide 500 WG Herbicide

Active constituent/s: 500 g/kg propyzamide

Applicant name: Sabakem Pty Ltd


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







Product name: Relyon MCPA LV 570 Herbicide

Active constituent/s: 570 g/L MCPA present as the 2-ethyl hexyl ester

Applicant name: Ruralco Holdings Ltd


Summary of use: For selective control of certain weeds in agricultural crops





Product name: Relyon Trifluralin 480 Herbicide

Active constituent/s: 480 g/L trifluralin



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

Date of registration: 2 March 2020



2. VARIATIONS OF REGISTRATION


Product name: EzyCrop S-Metolachlor 960 EC Herbicide

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

Applicant name: Ezycrop Pty Ltd


Summary of variation: To add the control of various weeds in sorghum treated with Concep II Sorghum Seed Safener

Date of variation: 20 January 2020




Product name: Weed Force Troll Broad Spectrum Knockdown Herbicide

Active constituent/s: 250 g/L amitrole, 220 g/L ammonium thiocyanate

Applicant name: Weed Force Pty Ltd


Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘weed force troll herbicide’ to ‘weed force troll broad spectrum knockdown herbicide ’

Date of variation: 10 February 2020






Product name: Relyon Bromo 200 Herbicide

Active constituent/s: 200 g/L bromoxynil present as the n-octanoyl ester



Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Bolt 200EC herbicide’ to ‘Relyon Bromo 200 herbicide’





Product name: Relyon Imazapic 240 Herbicide

Active constituent/s: 240 g/L imazapic as the ammonium salt



Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Flash 240 herbicide’ to ‘Relyon Imazapic 240 herbicide’





Product name: Relyon Paraquat 360 Herbicide

Active constituent/s: 360 g/L paraquat present as paraquat dichloride



Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Paraquick Plus 360 herbicide’ to ‘Relyon Paraquat 360 herbicide’





Product name: Relyon Brom-M Herbicide

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



Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Bolt MA herbicide’ to ‘Relyon Brom-M Herbicide





Product name: Relyon Propiconazole 250 EC Systemic Fungicide

Active constituent/s: 250 g/L propiconazole



Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Picaro 250EC Fungicide’ to ‘Relyon Propiconazole 250 EC Systemic Fungicide







Product name: Relyon Prothio T Fungicide

Active constituent/s: 210 g/L prothioconazole, 210 g/L tebuconazole



Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Raider 420SC Fungicide’ to ‘Relyon Prothio T Fungicide’





Product name: Relyon Tebuconazole 430 Fungicide

Active constituent/s: 430 g/L tebuconazole



Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Teboo 430SC Fungicide’ to ‘Relyon Tebuconazole 430 Fungicide’





Product name: Dry-Tec Disinfection Dry Chlorine

Active constituent/s: 680 g/kg chlorine present as calcium hypochlorite

Applicant name: Innovative Water Care International Pty Ltd


Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Frexus Disinfection Dry Chlorine’ to ‘Dry-Tec Disinfection Dry Chlorine’





Product name: Dry-Tec Granular Dry Chlorine




Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Frexus Granular Dry Chlorine’ to ‘Dry-Tec Granular Dry Chlorine’





Product name: Dry-Tec Duration Dry Chlorine




Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Frexus Duration Dry Chlorine’ to ‘Dry-Tec Duration Dry Chlorine’







Product name: Dry-Tec Briquettes Dry Chlorine




Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Frexus Briquettes Dry Chlorine’ to ‘Dry-Tec Briquettes Dry Chlorine’





Product name: Apparent Right Hook 800 EC Herbicide

Active constituent/s: 800 g/L prosulfocarb



Summary of variation: To update the label and formulation based on a nominated reference product





Product name: Coptrol Aquatic Algicide

Active constituent/s: 107 g/L copper as mixed copper chelates

Applicant name: Ruth Consolidated Industries Pty Ltd


Summary of variation: To update the safety directions of the product





Product name: Rainbow MCPA 750 Selective Herbicide

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

Applicant name: Shandong Rainbow International Co Ltd

Applicant ACN: N/A

Summary of variation: To add uses under the Permit to Label project and make minor updates to the label





Product name: Relyon Paraquat 250 Herbicide

Active constituent/s: 250 g/L paraquat present as paraquat dichloride



Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Relyon Paraquick 250 Herbicide’ to ‘Relyon Paraquat 250 Herbicide’







Product name: Genfarm Dicamba 500 Selective Herbicide

Active constituent/s: 500 g/L dicamba present as the dimethylamine salt

Applicant name: Landmark Operations Ltd


Summary of variation: To add use in pine plantations to encourage wood wasp attack and in rice to control dirty dora, docks, sedges and starfruit.





Product name: Farmalinx Zombie Fungicide

Active constituent/s: 200 g/L tebuconazole, 100 g/L trifloxystrobin



Summary of variation: To add use in ornamentals and add a disease in turf





Product name: Genfarm Tolex Liquid Fungicide

Active constituent/s: 500 g/L tolclofos-methyl

Applicant name: Landmark Operations Ltd


Summary of variation: Variation of product registration and label to add the use in lettuce to control Rhizoctonia solani





Product name: Kenso Agcare Ken-Mide 500 WG Herbicide


Applicant name: Kenso Corporation (M) Sdn Bhd

Applicant ACN: N/A

Summary of variation: To add pre-emergent uses in canola





Product name: Kenso Agcare Ken-Mide 900 WG Herbicide


Applicant name: Kenso Corporation (M) Sdn Bhd

Applicant ACN: N/A

Summary of variation: To add pre-emergent uses in canola







Product name: Coragen Insecticide

Active constituent/s: 200 g/L chlorantraniliprole

Applicant name: FMC Australasia Pty Ltd


Summary of variation: To add uses in strawberries and extend existing uses to include protected cropping situations





Product name: Tussock Herbicide

Active constituent/s: 745 g/L flupropanate present as the sodium salt

Applicant name: Grow Choice Pty Ltd


Summary of variation: To add use in tea tree for control of Giant Parramatta Grass





Product name: Lorox Linuron Flowable Herbicide

Active constituent/s: 480 g/L linuron

Applicant name: Tessenderlo Kerley Inc

Applicant ACN: N/A

Summary of variation: To register a new formulation and update the poison scheduling





Product name: Apparent Disturb 875 WG Herbicide

Active constituent/s: 875 g/kg terbuthylazine



Summary of variation: To include uses in chickpeas, faba beans, field peas, lupins, lentils, mung beans, soybeans, barley, oats and wheat





Product name: Apparent Atrazine 900 WG Herbicide

Active constituent/s: 900 g/kg atrazine



Summary of variation: To amend the label based on a reference product







Product name: Slasher Organic Weedkiller Ready To Use

Active constituent/s: 36.8 g/L nonanoic acid

Applicant name: Duluxgroup (Australia) Pty Ltd


Summary of variation: To add claims related to the fast action of the formulation and to add the situations of use bushland and forests





Product name: Slasher Organic Weedkiller

Active constituent/s: 525 g/L nonanoic acid

Applicant name: Duluxgroup (Australia) Pty Ltd


Summary of variation: To add claims related to the fast action of the formulation and to extend the current use pattern to include spot spraying in bushland and spot and band spraying in forestry situations





Product name: Smack Water Soluble Herbicide

Active constituent/s: 745 g/L flupropanate present as the sodium salt

Applicant name: Imtrade Australia Pty Ltd


Summary of variation: To add use in tea tree for control of Giant Parramatta Grass





Product name: Yates Home Pest Long Term Control Barrier Spray

Active constituent/s: 0.5 g/L lambda-cyhalothrin

Applicant name: Syngenta Australia Pty Ltd


Summary of variation: To change the product name to ‘Yates Home Pest Long Term Control Barrier Spray’, update statement of claims and directions for use to include control of all cockroaches





Product name: Apparent Diuron 900 WG Herbicide

Active constituent/s: 900 g/kg diuron



Summary of variation: To add uses in pulses, cereal rye and lucerne

Date of variation: 2 March 2020






Product name: Titan Clethodim 360 Selective Herbicide

Active constituent/s: 360 g/L clethodim



Summary of variation: To vary registration and label to add a formulation and formulation sites to registration details





Product name: Nufarm Crucial Advanced Technology Herbicide

Active constituent/s: 600 g/L glyphosate as potassium, monomethylamine & mono-ammonium salt

Applicant name: Nufarm Australia Ltd


Summary of variation: Variation of product registration and label approval to add use patterns in additional glyphosate tolerant crops




3. VARIATION OF LABEL APPROVAL


Product name: ProForce Regulate Plant Growth Regulator

Active constituent/s: 200 g/L paclobutrazol



Summary of variation: To approve a new label for the product 'Proforce Regulate Plant Growth Regulator' with the label name 'Farmalinx Pacman Turf Growth Regulator'





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: Clompoze 80 Tablets

Active constituent/s: 80 mg/tab clomipramine hydrochloride

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd


Summary of use: For treatment of stereotypic behaviours and anxiety disorders in dogs





Product name: Clompoze 20 Tablets

Active constituent/s: 20 mg/tab clomipramine hydrochloride

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd


Summary of use: For treatment of stereotypic behaviours and anxiety disorders in dogs





Product name: Solu-cillin FG

Active constituent/s: 870 g/kg amoxycillin as the trihydrate

Applicant name: South Yarra Pharma Pty Ltd


Summary of use: For the registration of a premix product for the treatment of amoxycillin susceptible infections of the alimentary, urogenital and respiratory tract of poultry, including organisms associated with Chronic Respiratory Disease (CRD) complex and diseases caused by E. coli





Product name: (Wagg & Purr) Puppies And Kittens Up To 2.5 Kg Fleas, Heartworm & Worms Spot On

Active constituent/s: 60 mg/mL selamectin

Applicant name: Avet Health Pty Ltd


Summary of use: For the registration of a spot-on parasiticide for puppies and kittens







Product name: (Wagg & Purr) Cats 2.6–7.5kg Fleas, Heartworm & Worms Spot On




Summary of use: For the registration of a spot-on parasiticide for cats





Product name: Duoshield LV + SE

Active constituent/s: 67.8 g/L levamisole (as levamisole hydrochloride), 50 g/L fenbendazole, 1 g/L selenium (as sodium selenate)



Summary of use: For the control of levamisole and fenbendazole sensitive mature and immature roundworms in sheep and lambs and as an aid in controlling selenium deficiencies in sheep and lambs





Product name: Restore CTC FG

Active constituent/s: 200 g/kg chlortetracycline hydrochloride (as calcium complex)

Applicant name: South Yarra Pharma Pty Ltd


Summary of use: For use as a feed supplement for prophylactic use when at risk from diseases and for the treatment of diseases caused by micro-organisms susceptible to chlortetracycline in calves, pigs and poultry





Product name: Covamectin Oral LV For Sheep

Active constituent/s: 2.0 g/L abamectin



Summary of use: For the treatment and control of abamectin sensitive strains of internal parasites (including benzimidazole, levamisole, and morantel resistant strains) of sheep and itch mite and nasal bot of sheep







Product name: Covine Moxy LA Injection For Sheep

Active constituent/s: 20 g/L moxidectin



Summary of use: For the treatment and control of roundworms, nasal bot and itch mite in sheep and for the protection against severe challenge by Haemonchus contortus (barber’s po le worm) for up to 4 months





Product name: (Wagg & Purr) Dogs 5.1–10kg Fleas & Heartworm Spot On




Summary of use: For the register of a spot-on parasiticide for dogs 5.1–10 kg





Product name: (Wagg & Purr) Puppies And Small Dogs Up To 4kg Fleas, Heartworm & Worms Spot On

Active constituent/s: 100 g/L imidacloprid, 25 g/L moxidectin



Summary of use: For registration of a spot-on parasiticide for puppies and small dogs up to 4 kg









Summary of use: For registration of a spot-on parasiticide for dogs 20.1–40 kg





Product name: (Wagg & Purr) Cats Over 4kg Fleas, Heartworm & Worms Spot On




Summary of use: For the registration of a spot-on parasiticide for cats







Product name: (Wagg & Purr) Dogs Over 25kg Fleas, Heartworm & Worms Spot On




Summary of use: To register a spot-on parasiticide for dogs





Product name: (Wagg & Purr) Dogs 10–25kg Fleas, Heartworm & Worms Spot On

Active constituent/s: 100 g/L imidacloprid, 25 g/L Moxidectin



Summary of use: To register spot-on parasiticide for dogs 10–25 kg









Summary of use: For the registration of a spot-on parasiticide for dogs 2.6–5 kg





Product name: (Wagg & Purr) Puppies And Small Dogs Up To 4kg Fleas, Heartworm & Worms Spot On




Summary of use: To register a spot-on parasiticide for puppies and small dogs up to 4 kg





Product name: (Wagg & Purr) Dogs 4–10kg Fleas, Heartworm & Worms Spot On




Summary of use: For registration of spot-on parasiticide for dogs 4–10 kg







Product name: Toromec LV Pour On For Cattle

Active constituent/s: 10 mg/mL ivermectin



Summary of use: For the treatment and control of ivermectin sensitive internal and external parasites of beef and dairy cattle




2. VARIATIONS OF REGISTRATION


Product name: Tulissin Injectable Solution

Active constituent/s: 100 mg/mL tulathromycin

Applicant name: Virbac (Australia) Pty Ltd

Applicant ACN: 77 003 268 871

Summary of variation: Variation of conditions of the product registration and label approval for Tulissin Injectable Solution, to vary the product shelf life and in-use shelf life




3. LABEL APPROVAL


Product name: Apex Meloxicam 20 mg/mL Solution For Injection For Cattle, Pigs, Horses And Sheep

Active constituent/s: 20 mg/mL meloxicam

Applicant name: Le Vet Beheer B V

Applicant ACN: N/A

Summary of variation: To approve a new label for the product 'Meloxidolor 20 MG/ML solution for injection for cattle, pigs, horses and sheep' with the new label name ‘Apex Meloxicam 20 mg/ml solution for injection for cattle, pigs, horses and sheep’





Product name: Apex Meloxicam 5mg/mL Solution for Injection for Dogs and Cats

Active constituent/s: 5 mg/mL meloxicam

Applicant name: Le Vet Beheer B V

Applicant ACN: N/A

Summary of variation: To approve a new label for the product 'Meloxidolor 5 mg/ml solution for injection for dogs and cats’ with the new label name 'Apex Meloxicam 5mg/ml solution for injection for dogs and cats’






4. VARIATION OF LABEL APPROVAL


Product name: Pastoral Ag Imidacloprid Pour-On Lice Treatment for Sheep

Active constituent/s: 35 g/L imidacloprid



Summary of variation: To update the label to include constituents, claims and safety information





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: Tetramethrin

Applicant name: Agro-Alliance (Australia) Pty Ltd


Summary of use: For use in agricultural chemical products

Date of approval: 17 February 2020

Approval no.: 87018


Active constituent/s: Neomycin sulfate

Applicant name: Newmarket Ingredients Pty Ltd


Summary of use: For use in veterinary chemical products


Approval no.: 88611


Active constituent/s: Moxidectin

Applicant name: Shanghai Neway Animal Health Co Ltd

Applicant ACN: N/A



Approval no.: 88678


Active constituent/s: Chlorthal-dimethyl

Applicant name: Imtrade Australia Pty Ltd




Approval no.: 88311


Active constituent/s: Pinoxaden





Approval no.: 88407




Active constituent/s: Ivermectin

Applicant name: Intervet Australia Pty Ltd




Approval no.: 88510


Active constituent/s: Tiafenacil

Applicant name: FarmHannong Co Ltd.

Applicant ACN: N/A



Approval no.: 86287


Active constituent/s: lotilaner

Applicant name: Elanco Australasia Pty Ltd




Approval no.: 88307


Active constituent/s: Spiropidion

Applicant name: Syngenta Australia Pty Ltd


Summary of use: For use in agricultural chemical products.


Approval no.: 86420


Active constituent/s: Aminopyralid

Applicant name: TGAC Australia Pty Ltd




Approval no.: 88517


Active constituent/s: Glufosinate-ammonium

Applicant name: Fufarm Co Pty Ltd



Date of approval: 2 March 2020

Approval no.: 87854


New agricultural active constituent: methiozolin


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

new active constituent, methiozolin, for control of winter grass in turf.

PARTICULARS OF THE ACTIVE CONSTITUENT

Common Name: Methiozolin

IUPAC Name: (5RS)-5-[(2,6-difluorobenzyloxy)methyl]-4,5-dihydro-5-methyl-3-(3-methyl-2-thienyl)-

1,2-oxazole

CAS Name: 5-[[(2,6-difluorophenyl)methoxy]methyl]-4,5-dihydro-5-methyl-3-(3-methyl-2-

thienyl)isoxazole

CAS Registry Number: 403640-27-7

Minimum Purity: 990 g/kg (dry weight basis)

Molecular Formula: C17H17F2NO2S

Molecular Weight: 337.4 gmol-1

Structure:

Chemical Family: Oxazole compound

SUMMARY OF THE APVMA’S EVALUATION OF METHIOZOLIN ACTIVE CONSTITUENT

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

identification, stability, 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 methiozolin. There are currently no proposed uses in food

crops, and neither an ADI nor an ARfD have been established.

The Scheduling Delegate has made an interim decision to include methiozolin in Schedule 5 of the Poison Standard, with

no cut-off, with a proposed date of effect of 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 methiozolin:

Constituent Level

Methiozolin Minimum 990 g/kg

Impurities of toxicological significance are not expected to occur in methiozolin as a result of the raw materials and the

synthetic route used.



The APVMA is satisfied that the proposed importation and use of methiozolin would not be an undue hazard to the safety

of people exposed to it during its handling and use.

MAKING A SUBMISSION

In accordance with section 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission

as to whether the application for approval of methiozolin 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)

postal address

email 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 Manufacture

Scientific Assessment and Chemical Review Program


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300


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



New chemical product: Campbell Poacure Turf Herbicide containing methiozolin


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

new product containing a new active constituent. The product is Campbell Poacure Turf Herbicide.

PARTICULARS OF THE APPLICATION

Proposed product name(s): Campbell Poacure Turf Herbicide

Applicant company: Colin Campbell (chemicals) Pty Ltd

Name of active constituent: Methiozolin

Signal heading: Schedule 5 (interim decision, proposed date of effect 1 June 2020)

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

Pack sizes: 500 mL and 1 L

Withholding period: Not applicable

SUMMARY OF THE APVMA’S EVALUATION OF CAMPBELL POACURE TURF HERBICIDE IN ACCORDANCE

WITH THE REQUIREMENTS OF SECTION 14(1)(C) OF THE AGRICULTURAL AND VETERINARY CHEMICALS

CODE (THE ‘AGVET CODE’), SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT

1994

1. The APVMA has considered the formulation of the product, Campbell Poacure Turf Herbicide. The toxicological profile of

all of the Campbell Poacure Turf Herbicide constituents is well established, and the key health hazards linked to use of

the formulated product Campbell Poacure Turf Herbicide are related to moderate eye and skin irritation. First Aid

Instructions and Safety Directions (FAISD) to be displayed on the product label have been developed to adequately

mitigate the risks resulting from use of the product.

The APVMA has evaluated the application and in its assessment in relation to whether the safety criteria have been met

in accordance with the definition set out in section 5A of the Agvet Code, and proposes to determine that:

(i) The APVMA is satisfied that the proposed use of Campbell Poacure Turf Herbicide would not be an undue hazard

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

The APVMA has conducted a risk assessment on the product and concluded that it can be used safely. Noting the

use of the product is in non-food producing situations, an ADI and ARfD have not been set for the active

constituent.

(ii) The APVMA is satisfied that the proposed use of Campbell Poacure Turf Herbicide will not be an undue hazard to

the safety of people using anything containing its residues.

The proposed product is for exclusive use on professionally prepared recreational turf such as golf clubs, bowling

clubs, and playing grounds (eg, ovals and stadia). The product is NOT intended to be use as a home garden

product so householders will not be applying it to their own lawns.

(iii) The APVMA is satisfied that the proposed use of Campbell Poacure Turf Herbicide containing the active

constituent methiozolin is not likely to be harmful to human beings if used according to the product label directions.



(iv) The APVMA is satisfied that the proposed use of the new product, Campbell Poacure Turf Herbicide, containing

the active constituent methiozolin would not be likely to have an unintended effect that is harmful to animals, plants

or things, or the environment.

The APVMA has considered the available environmental fate and effects data in support of the proposed use and

has concluded that the risks to the environment are acceptable.

Methiozolin is considered to be moderately persistent in soil under field conditions, with more rapid dissipation

when applied to turf. In aquatic system, methiozolin partitioned moderately fast from the water phase to the

sediment, with slow degradation in the whole system. Methiozolin is unlikely to be subject to long- or short-range

transport in the air.

Risks to terrestrial vertebrates and soil organisms were determined to be acceptable. A food chain assessment

indicated that any accumulated residues in earthworms or fish are not expected to reach levels harmful to

predators and biomagnification is not expected along the food chain. No specific protection statements are required

for these non-target taxa.

Methiozolin is highly toxic to aquatic plants, and moderately toxic to fish, aquatic invertebrates, and algae. Risks of

spray drift were determined to be acceptable with mandatory buffer zones ranging 30 to 90 metres depending on

the application rate and the boom height. Runoff risks were acceptable for recreational turf situations, with the

exception of use in Tasmania on golf courses. Therefore, the product is not permitted for use on golf fairways in

Tasmania adjacent to natural waterways. To minimise risks of runoff in all situations, the product must also not be

applied if heavy rains or storms are forecast within three days and the treatment area must not be irrigated to the

point of runoff for at least three days after application.

Long-term exposure of bee larvae to methiozolin resulted in reduced survival at high doses. Although risks are low,

as a precautionary measure, spray drift is not permitted to flowering plants and beekeepers must be notified if there

is potential for managed hives to be affected by the treatment.

Contact exposure to fresh-dried residues of methiozolin on a natural substrate resulted in a dose-response impact

on reproduction of the parasitic wasp. The product is not considered to be compatible with integrated pest

management programs (IPM) utilising beneficial arthropods.

Methiozolin was shown to be a selective herbicide and only certain non-target terrestrial plants were affected.

Spray drift risks were determined to be acceptable without buffer zones, provided the standard spray drift restraints

are followed.

Based on an assessment of the environmental data, it was considered that there should be no unacceptable

adverse effects on non-target organisms from the use of Campbell Poacure Turf Herbicide when used in

accordance with label directions.

2. The APVMA has evaluated the application and in its assessment in relation to whether the efficacy criteria have been

met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:

(i) In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials

supporting the efficacy of the product adequately demonstrate that, if used according to the product label

directions, the product is effective for its proposed uses.

3. The APVMA has evaluated the application and in its assessment in relation to whether the trade criteria have been met

in accordance with the definition set out in section 5C of the Agvet Code, and proposes to determine that:



(i) The APVMA is satisfied that the proposed use of Campbell Poacure Turf Herbicide would not adversely affect trade

between Australia and places outside Australia as the product is not for use in food crops or animals producing any

major Australian export commodities.

MAKING A SUBMISSION


as to whether Campbell Poacure Turf Herbicide should be registered. Submissions should relate only to matters that are

required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have

been met. Submissions should state the grounds on which they are based.



Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and

in determining appropriate conditions of registration and product labelling.

When making a submission please include:

contact name


postal address




confidentially.


Case Management and Administration Unit


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300





New active constituent: tetraniliprole

New agricultural active constituent: tetraniliprole

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

new active constituent, tetraniliprole, for use in agricultural chemical products as an insecticide.

Common Name: Tetraniliprole

IUPAC Name: 1-(3-chloropyridin-2-yl)-N-(4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide

CAS Name: 1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-[(methylamino)carbonyl]phenyl]-3-[[5-

(trifluoromethyl)-2H-tetrazol-2-yl]methyl]-1H-pyrazole-5-carboxamide

CAS Registry Number: 1229654-66-3

Manufacturer’s Codes: BCS-CL73507

Minimum Purity: 900 g/kg

Molecular Formula: C22H16ClF3N10O2

Molecular Weight: 544.88 g/mol

Structure:

Chemical Family: Anthranilamide insecticide.

Mode of Action: Tetraniliprole is a diamide insecticide of the anthranilamide group of insecticides that

works by activation of the ryanodine receptors in the calcium release channel, leading

to loss of muscle control and paralysis of the insects.

SUMMARY OF THE APVMA’S EVALUATION OF TETRANILIPROLE ACTIVE CONSTITUENT

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

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

and found them to be acceptable.

The APVMA has completed a toxicological evaluation of tetraniliprole.

An Acceptable Daily Intake (ADI) for tetraniliprole was established at 0.90 mg/kg bw/d. An Acute Reference Dose (ARfD)

for tetraniliprole was considered unnecessary.

The Scheduling Delegate made an interim decision to include tetraniliprole in Schedule 5, except in preparations

containing 20 per cent or less if tetraniliprole, with a proposed implementation date of 1 June 2020.


New active constituent: tetraniliprole

On the basis of the data provided, and the toxicological assessment, it is proposed that the following APVMA Active

Constituent Standard be established for tetraniliprole:

Specification Level

Tetraniliprole content Minimum 900 g/kg

Other compounds of toxicological significance are not expected to occur in tetraniliprole technical active constituent.

The APVMA is satisfied that the proposed importation and use of tetraniliprole 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 tetraniliprole should be granted. Submissions should relate only to matters

are considered in determining whether the safety criteria set out in section 5A of the Agvet Code are met. Submissions

should state the grounds on which they are based.



When making a submission please include a:

contact name


postal address




confidentially.

Submissions should be addressed in writing to:

Director Chemistry and Manufacture

Risk Assessment Capability


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300





New chemical product: Vayego 200 SC Insecticide containing tetraniliprole


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

new product containing a new active constituent. The product is Vayego 200 SC Insecticide.

PARTICULARS OF THE APPLICATION

Proposed product name(s): Vayego 200 SC Insecticide

Applicant company: Bayer CropScience Pty Ltd

Name of active constituent: Tetraniliprole

Signal heading: Unscheduled. Does not require control by scheduling

Summary of proposed use: For the control of various pests of almonds, macadamias, pome fruit and

stone fruit

Pack sizes: 1–110 L

Withholding period: Harvest (H)

Stone fruit: do not harvest for 3 days after application

Pome fruit: do not harvest for 7 days after application

Tree nuts: do not harvest for 10 days after application

Grazing (G)

Pome fruit, stone fruit, tree nuts: do not graze treated orchard

SUMMARY OF THE APVMA’S EVALUATION OF VAYEGO 200 SC INSECTICIDE IN ACCORDANCE WITH THE

REQUIREMENTS OF SECTION 14(1)(C) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (THE

‘AGVET CODE’), SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994

1. The APVMA has evaluated the application and in its assessment in relation to whether the safety criteria have been met

in accordance with the definition set out in section 5A of the Agvet Code, and proposes to determine that:

(i) The APVMA is satisfied that the proposed use of Vayego 200 SC Insecticide would not be an undue hazard to the

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

(ii) The APVMA is satisfied that the proposed use of Vayego 200 SC Insecticide will not be an undue hazard to the

safety of people using anything containing its residues.

(iii) The APVMA is satisfied that the proposed use of Vayego 200 SC Insecticide is not likely to be harmful to human

beings if used according to the product label directions.

(iv) The APVMA is satisfied that the proposed use of Vayego 200 SC Insecticide is not likely to have an unintended

effect that is harmful to animals, plants, or things or the environment if used according to the product label

directions.



2. The APVMA has evaluated the application and in its assessment in relation to whether the efficacy criteria have been

met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:

(i) In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials

supporting the efficacy of the product adequately demonstrate that if used according to the product label directions,

the product is effective for its proposed uses.

3. The APVMA has evaluated the application and in its assessment in relation to whether the trade criteria have been met

in accordance with the definition set out in section 5C of the Agvet Code, and proposes to determine that:

(i) The APVMA is satisfied that the proposed use of Vayego 200 SC Insecticide would not adversely affect trade

between Australia and places outside Australia.

FURTHER INFORMATION

A Public Release Summary (PRS) of the evaluation of the product Vayego 200 SC Insecticide is available from the

APVMA website’s ‘Public Consultation’ page, or by contacting the APVMA as listed below.

MAKING A SUBMISSION


as to whether Vayego 200 SC Insecticide should be registered. Submissions should relate only to matters that are

required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have

been met. Submissions should state the grounds on which they are based.



Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and

in determining appropriate conditions of registration and product labelling.

When making a submission please include:

contact name


postal address




confidentially.


https://apvma.gov.au/node/64526




Case Management and Administration Unit


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300




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. 2) 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/F2019L01105



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

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

In the previous notice on page 35 of APVMA Gazette No. 5, 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. 2) 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

(2 March 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: paracetamol

Permitted residue: paracetamol

Pig fat/skin *0.1

Pig kidney *0.1

Pig liver *0.1

Pig 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: cyazofamid

All 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 T0.3

Soya bean (dry) T0.3

Agvet chemical: fludioxonil

Permitted residue: commodities of animal origin: Sum of fludioxonil and oxidisable metabolites, expressed as fludioxonil

Permitted residue—commodities of plant origin: Fludioxonil

Papaya T5



Agvet chemical: fluopicolide

Permitted residue: fluopicolide

Basil T30

Agvet chemical: indoxacarb

Permitted residue: Sum of indoxacarb and its R-isomer

Walnuts T0.02

Agvet chemical: metolachlor

Permitted residue: metolachlor

Pulses [except soya beans (dry); adzuki beans (dry)]

*0.01

Agvet chemical: napropamide

Permitted residue: napropamide


*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: fluopicolide

Brassica (cole or cabbage) 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*0.05

Pulses [except adzuki bean (dry); mung bean (dry); soya bean (dry)]

*0.01

Agvet chemical: propamocarb

Permitted residue: propamocarb (base)

Leafy vegetables 70



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) 7 APRIL 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


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2401




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

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

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

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

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

Standards Code. This notice pertains to proposals (No. 3) gazetted on 19 November 2019 (No. APVMA 23).

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

2, 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 Officer


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2383


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 2, 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 Second day of March 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 2, 2020.

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 20maximum residue limits in the Australia New Zealand Food Standards Code to include or change maximum residue limits pertaining to agricultural and veterinary chemical products.

4 Interpretation

In this instrument:—

APVMA means the Australian Pesticides and Veterinary Medicines Authority established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; and

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

Part 2 Variations to Schedule 20—maximum residue limits

5 Variations to Schedule 20

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



Schedule

Variations to Schedule 20–maximum residue limits

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

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

Agvet chemical: 2,4-D

Permitted residue: 2,4-D

Walnuts *0.05

Agvet chemical: bifenthrin

Permitted residue: bifenthrin

Truffle T*0.01

Agvet chemical: glufosinate and glufosinate-ammonium

Permitted residue: sum of glufosinate-ammonium, N-acetyl glufosinate and 3-[hydroxy(methyl)-phosphinoyl] propionic acid, expressed as glufosinate (free acid)


0.1

Truffle T*0.2

Agvet chemical: glyphosate

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

Truffle T*0.05

Agvet chemical: mesotrione

Permitted residue: mesotrione

Barley *0.01

Edible offal (mammalian) *0.01

Eggs *0.01

Meat (mammalian) *0.01

Milks *0.01

Poultry, edible offal of *0.01

Poultry meat *0.01

Wheat *0.01

Agvet chemical: methiocarb

Permitted residue: sum of methiocarb, its sulfoxide and sulfone, expressed as methiocarb

Truffle T0.05


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

Number

Name Type of approval or

registration

Holder Date of

Cancellation

30616/0501

30616/50624

Campbell Flowable

Tmtd Fungicide

Label approvals Colin Campbell

(Chemicals) Pty Ltd

11 February 2020

31364 Watrol Non-Residual

Herbicide

Product registration Nch Australia Pty Ltd 11 February 2020

46227/02

46227/0505

46227/0710

46227/0805

46227/0899

46227/0901

46227/1004

46227/1099

46227/1102

46227/58490

46227/58490AA

Gaucho 600 Flowable

Seed Treatment

Insecticide

Label approvals Bayer Cropscience Pty

Ltd

16 January 2020

54548 Malice Insecticide Product registration Nch Australia Pty Ltd 11 February 2020

54659/0203 Barmac Thiram Liquid

Fungicide

Label approval Amgrow Pty Ltd 11 February 2020

54886/0602 Chemag Dicamba -

Mcpa Herbicide

Label approval Imtrade Australia Pty Ltd 11 February 2020

56254/0614 Wsd Command Pour-

On Lousicide For

Sheep

Label approval Wsd Agribusiness Pty

Ltd

16 January 2020

60646 Carbofuran Active Sinon Australia Pty Ltd 31 January 2020

60752/38820

60752/55289

60752/55679

Eclipse Combination

Pour-On For Cattle

Label approvals Boehringer Ingelheim

Animal Health Australia

Pty Ltd

11 February 2020

60935/0506 Smart Metribuzin 750

Wg Herbicide

Label approval Crop Smart Pty Ltd 16 January 2020

63128/0808 Set-Up Dry 680

Herbicide

Label approval Imaspro Resources Sdn

Bhd

16 January 2020



Approval or

Registration

Number

Name Type of approval or

registration

Holder Date of

Cancellation

63372/0808 Aw Muffle 480 Sc

Herbicide

Label approval Agri West Pty Ltd 16 January 2020

63488/0409

63488/0110

Fido's Flea And Tick

Rinse Concentrate For

Dogs

Label approvals Mavlab Pty Ltd 16 January 2020

64104/49905 Imbrex Fungicide Label approval Basf Australia Ltd 16 January 2020

64337/1009 Titan Mcpa 750

Selective Herbicide

Label approval Titan Ag Pty Ltd 16 January 2020

64451/0410

64451/59895

Accensi

Thiram/Thiabendazole

Fungicidal Liquid Seed

Dressing

Label approvals Accensi Pty Ltd 16 January 2020

64746/53709 Garlon Fallowmaster

Herbicide

Label approval Dow Agrosciences

Australia Limited

16 January 2020

65917/52295

65917/112708

Imtrade Hurricane

Ultimate 750 Herbicide

Label approvals Imtrade Australia Pty Ltd 15 January 2020

67545/56338 Genfarm Thiram 600

Fungicide

Label approval Landmark Operations

Limited

16 January 2020

68150/57634

68150/102740

68150/113852

Nobility Systemic

Fungicide

Label approvals Crop Culture Pty 16 January 2020

80874/ 101859 Eureka! Triadimefon

125 Ec Fungicide

Label approval Eureka! Agresearch Pty

Ltd

16 January 2020

82050/104872 Agro-Essence Fipronil

200sc Insecticide

Label approval Agro-Alliance (Australia)

Pty Ltd

16 January 2020

82974/107245 Imtrade Triclopyr 750

Ec Herbicide

Label approval Imtrade Australia Pty Ltd 16 January 2020

83387/108161 Sharda Fipronil 200 Sc

Insecticide

Label approval Sharda Cropchem

Espana S.L

16 January 2020

83396/108178 4farmers Triclopyr 755

Herbicide

Label approval 4 Farmers Australia Pty

Ltd

16 January 2020

85020 Lsa Crop-Assist Product registration Bernadini Pty Ltd 11 February 2020

86643/116252 Dynasty Pd Fungicide

Seed Treatment

Label approval Syngenta Australia Pty

Ltd

11 February 2020

In accordance with section 45A(1)(b) of the Agvet Code, the APVMA publishes this notice of the cancellation, including

the following instructions 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.



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

45B(3) 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.

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 Review


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2400




Pesticide and veterinary medicines product sales 2018–19 financial year


This notice provides the collated final product sales information provided to the APVMA for the 2018–19 financial year.

AGRICULTURAL (PESTICIDES) PRODUCT SALES FOR THE 2018–19 FINANCIAL YEAR

AGRICULTURAL PRODUCT TYPES NO OF PRODUCTS DECLARED SALES $

Adjuvants/surfactants 458 95 049 718.00

Antifouling—boat 52 17 468 648.00

Dairy cleanser 124 12 224 060.00

Disinfectant/sanitiser 106 13 046 023.00

Fungicide 1 088 242 806 378.00

Growth promoters/regulators 279 44 932 865.00

Herbicide 3 643 1 507 043 933.00

Household insecticide 640 144 051 003.00

Insecticide 1 570 358 955 459.00

Misc (eg: seed safeners, markers etc) 77 7 048 108.00

Miticide 134 25 338 495.00

Mixed function pesticide 145 32 161 047.00

Molluscicide 51 13 048 179.00

Nematicide 17 3 277 307.00

Pool products/algicide 642 69 820 910.00

Repellent—dogs/birds etc 19 1 356 692.00

Seed treatments 177 70 474 922.00

Vertebrate poison 239 17 338 060.00

Wood preservative 117 61 159 317.00

Grand Total 9 578 2 736 601 124.00



VETERINARY MEDICINES PRODUCT SALES FOR THE 2018–19 FINANCIAL YEAR

VETERINARY PRODUCT

TYPES USES

NO OF

PRODUCTS TOTAL $

Alimentary system Anti-bloat 18 1 870 946.00

Alimentary system Antidiarrhoeals and scour treatments 17 1 216 825.00

Alimentary system Laxatives, purgatives, lubicants,

antispasmodics 15 6 165 044.00

Anaesthetics/analgesics Anaesthetics—local and general 54 15 953 104.00

Anaesthetics/analgesics Analgesics 20 10 479 198.00

Antibiotic & related Antibiotic—intramammary 31 23 199 618.00

Antibiotic & related Antibiotic—oral 219 52 231 785.00

Antibiotic & related Antibiotic—parenteral 72 28 682 608.00

Antibiotic & related Other anti-infective agents 43 1 549 589.00

Antibiotic & related Sulfonamides 37 3 646 611.00

Antidotes Antidotes 15 1 462 980.00

Cardiovascular system Cardiac reactants, clotting agents 69 9 917 312.00

Central nervous system Hypnotics, tranquilizers, emetics, antiemetics 43 7 399 323.00

Dermatological preps. Antibiotics, antifungals, corticosteroid

combinations 28 4 490 469.00

Dermatological preps. Antiseptics (dermatological and general) 131 22 473 762.00

Dermatological preps. Nonsteroidal antipruritics, keratolyics 28 5 893 301.00

Ear,nose,throat preps. Aural 26 8 681 187.00

Endocrine system Anabolic steroids 21 449 290.00

Endocrine system Corticosteroids and adrenal compounds 31 3 873 017.00

Endocrine system Sex hormones 55 13 707 574.00

Endocrine system Tropic hormones (pituitary) & insulin

preparations 39 23 985 696.00

Genitourinary system Diuretics, acidifiers, alkanisers 26 2 027 559.00

Genitourinary system Uterine or vaginal acting agents 7 611 868.00

Immunotherapy Antisera, antivenom 9 2 582 226.00

Immunotherapy Immunomodifying agents 11 1 578 147.00

Immunotherapy Injectable vaccines 183 171 723 204.00



VETERINARY PRODUCT

TYPES USES

NO OF

PRODUCTS TOTAL $

Immunotherapy Nasal, oral, opthalmic vaccines 37 31 473 290.00

Misc.

Eg: equipment disinfectants, behaviour

modifiers, general dermatological

preparations, antihistamines, miscellaneous

etc.

95 44 238 253.00

Musculoskeletal system Anti-inflammatory agents 225 39 187 478.00

Musculoskeletal system Counter-irritants, rubefacients, poultices 12 2 801 384.00

Nutrition & metabolism Antibiotic and anti-infective supplements 41 6 725 867.00

Nutrition & metabolism Dietary/therapeutic pet foods 16 2 844 568.00

Nutrition & metabolism Digestive enzyme supplements 11 1 928 199.00

Nutrition & metabolism Electrolytes 51 4 060 296.00

Nutrition & metabolism Growth promotants 57 31 553 368.00

Nutrition & metabolism Iron and haemopoietic agents 22 1 621 783.00

Nutrition & metabolism Probiotic and prebiotic 7 1 953 165.00

Nutrition & metabolism Tonics, stimulants 12 352 655.00

Nutrition & metabolism Vitamin, mineral, & nutritional supplements 187 31 820 697.00

Ophthalmic preparations Ophthalmic preparations 19 5 325 785.00

Parasiticides Birds—external 9 418 078.00

Parasiticides Birds—internal 31 3 929 262.00

Parasiticides Large & small animals external 17 1 943 153.00

Parasiticides Large animals—external 245 78 465 154.00

Parasiticides Large animals—internal 291 73 940 867.00

Parasiticides Large animals—internal & external 138 65 630 990.00

Parasiticides Small animals—external 229 101 844 093.00

Parasiticides Small animals—internal 248 82 382 854.00

Parasiticides Small animals internal and external 71 55 807 373.00

Respiratory system Expectorants, mucolytics, decongestants,

bronchodilators, resp. Stim 18 1 105 216.00

Grand Total 3 337 1 097 206 071.00



APVMA CONTACT


Finance Officer

Corporate Services


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2355



apvma gazette no. 05, 10 march 2020 · commonwealth of australia gazette no. apvma 5, tuesday, 10...

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