APVMA Gazette No. 22, 5 November 2019€¦ · Web viewand skin lesions caused by Habronema and Draschia species and Onchocerca species Date of registration: 24 October 2019 Product

Gazette Agricultural andVeterinary Chemicals

No. APVMA 22, Tuesday, 5 November 2019

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

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 required

by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material

issued by the APVMA.

Pursuant to section 8J(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications

made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

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

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

form .

APVMA CONTACTS

For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6770 2300.

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

https://apvma.us2.list-manage.com/subscribe?u=f09f7f9ed2a2867a19b99e2e4&id=a025640240

https://apvma.us2.list-manage.com/subscribe?u=f09f7f9ed2a2867a19b99e2e4&id=a025640240

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

Commonwealth of Australia GazetteNo. APVMA 22, Tuesday, 5 November 2019 Agricultural and Veterinary Chemicals Code Act 1994

CONTENTS

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

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

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

New Chemical Product: Vedira suite of products containing the new active broflanilide.......................................................

New Active Constituent: Broflanilide......................................................................................................................................


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.: 121132

Product name: Chemblend White Ant Termite Bait

Active constituent/s: 1.0 g/kg chlorfluazuron

Applicant name: Vaughany Holdings Pty Ltd

Applicant ACN: 630 311 036

Summary of use: For use as part of a termite interception and baiting system, an integrated system for the management of subterranean termite infestations (except Mastotermes darwiniensis)

Date of registration: 15 October 2019

Product registration no.:

88373

Label approval no.: 88373/121132


Product name: Long Life Liquid Chlorine Pool And Spa Sanitiser

Active constituent/s: 110 g/L available chlorine (Cl) present as sodium hypochlorite

Applicant name: Bond Chemicals Pty Ltd


Summary of use: For control of bacteria, viruses and protozoa in swimming pools and spas



87738



Product name: Genfarm Fipronil 800 WG Insecticide

Active constituent/s: 800 g/kg fipronil

Applicant name: Landmark Operations Limited


Summary of use: For use in bananas, brassicas, cotton, wine grapevines, mushrooms, pasture, potatoes, sorghum and sugarcane



88394



Product name: Richgro Cockroach Killer Gel

Active constituent/s: 0.5 g/kg fipronil

Applicant name: A Richards Pty Ltd


Summary of use: For control of cockroaches



87748





Product name: HTH Granular+ Mineralsoft Pool Chlorine

Active constituent/s: 600 g/kg available chlorine (Cl) present as calcium hypochlorite

Applicant name: Innovative Water Care International Pty Ltd


Summary of use: For control of bacteria, viruses and protozoa in swimming pools



87626



Product name: Roundup Natural* Weedkiller

Active constituent/s: 18.3 g/L nonanoic Acid

Applicant name: Evergreen Garden Care Australia Pty Ltd


Summary of use: For treatment of broadleaf weeds, clover, grasses, algae and moss on paths, garden beds, rockeries, lawns, driveways, lawn edges and fences



87008



Product name: Onil Fungicide

Active constituent/s: 250 g/L triadimenol

Applicant name: Industrial Quimica Key SA

Applicant ACN: N/A

Summary of use: For systemic control of Ring Spot in Brassica vegetables (cabbage, cauliflower, broccoli and brussels sprouts), control of powdery mildew in Cucurbits, eggplant, grapevines, tomatoes, papaws and peppers and control of Pineapple disease in sugar cane



88395



Product name: Firepower 900 Herbicide

Active constituent/s: 900 g/L haloxyfop present as haloxyfop-p methyl ester

Applicant name: Adama Australia Pty Limited


Summary of use: For the control of various weeds



87107



Product name: Insect Shield Apparel & Gear

Active constituent/s: 5.2 g permethrin active per kg of garment fabric

Applicant name: Insect Shield LLC

Applicant ACN: N/A

Summary of use: For use to repel mosquitoes, ticks files, ants, chiggers and midges



86205





Product name: Spalding Pic-T Herbicide

Active constituent/s: 200 g/L triclopyr present as the triethylamine salt, 100 g/L picloram present as triisopropanolamine salt

Applicant name: Spalding Holdings Pty Ltd


Summary of use: For the control of unwanted timber by stem injection or cut stump/brush cutter application and control of blackberry, gorse and harrisia cactus by foliage spray



88416



Product name: Vitalyse Poly Pro Algaecide

Active constituent/s: 685 g/L poly[oxyethylene(dimethyliminio)ethylene(dimethyliminio)ethylene dichloride]polymeric quaternary ammonium compound

Applicant name: Focus Products Pty Ltd


Summary of use: For the control of algae in swimming pools



88326



Product name: Pureblue Spa Sanitiser

Active constituent/s: 510 g/kg available chlorine (CI) present as sodium dichloroisocyanurate, 150 g/kg sodium bromide

Applicant name: United Eastern Chemicals Pty Ltd


Summary of use: For control of algae and bacteria in spas



88422



Product name: Unison Herbicide

Active constituent/s: 208 g/L 2,4-D acid

Applicant name: Helena Agri-Enterprises LLC

Applicant ACN: N/A

Summary of use: For the control of broadleaf weeds in fallow before direct drilling or sowing of cereals and pastures; and in cereal crops, pastures, sugar cane, peanuts and non-agricultural areas



86960





Product name: Rodenthor Gel Rodenticide

Active constituent/s: 0.05 g/kg brodifacoum

Applicant name: Zapi SPA

Applicant ACN: N/A

Summary of use: For control of rats and mice in various situations



87706



Product name: Macspred BestWet Organosilicone Penetrant And Wetting Agent

Active constituent/s: 1020 g/L polyether modified polysiloxane

Applicant name: Macspred Pty Ltd


Summary of use: For use as a wetter/spreader/penetrant for use with agricultural pesticides



88408



Product name: Smart Team T Seed Dressing

Active constituent/s: 360 g/L thiram, 200 g/L thiabendazole

Applicant name: Crop Smart Pty Ltd


Summary of use: For the control of seed-borne and seedling root pathogens of peas, chickpeas, lentils, faba beans and vetch



88390



Product name: Scotts Performance Naturals Weedkiller

Active constituent/s: 18.3 g/L nonanoic acid

Applicant name: Evergreen Garden Care Australia Pty Ltd


Summary of use: For treatment of broadleaf weeds, clover, grasses, algae and moss on paths, garden beds, rockeries, lawns, driveways, lawn edges and fences



87420



Product name: Lambdaplus Insecticide

Active constituent/s: 50 g/L lambda-cyhalothrin, 20 g/L pyriproxyfen

Applicant name: Sherwood Chemicals Australasia Pty Ltd


Summary of use: For the control of various insect pests in commercial, domestic, industrial and public situations



86720





Product name: Marisol Insecticide

Active constituent/s: 18 g/L abamectin

Applicant name: Industrial Quimica Key SA

Applicant ACN: N/A

Summary of use: For the control of pest mites and native budworm on cotton. For control of pest mites on pears, apples, capsicums, tomatoes, strawberries and ornamentals



88427



Product name: Midas Turf Fungicide

Active constituent/s: 500 g/kg boscalid

Applicant name: BASF Australia Ltd


Summary of use: For use in turf



88429



Product name: Imtrade Diazinon 800 EC Insecticide

Active constituent/s: 800 g/L diazinon (an anticholinesterase compound)

Applicant name: Imtrade Australia Pty Ltd


Summary of use: For the control of macadamia leafminer and felted coccid in macadamias



87681



Product name: Farmalinx Challenger Fungicide

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

Applicant name: Farmalinx Pty Ltd


Summary of use: For the control of blackleg and sclerotinia stem rot in canola



86333



Product name: Methograin Delta IGR Grain Protectant

Active constituent/s: 400 g/L piperonyl butoxide, 50 g/L deltamethrin, 30 g/L s-methoprene

Applicant name: Babolna Bioenvironmental Centre Ltd

Applicant ACN: N/A

Summary of use: For use as a grain protectant for protection against various stored grain insect pests, including organophosphate-resistant strains



86506





Product name: 4Farmers Paraquat 300 Herbicide

Active constituent/s: 300 g/L paraquat, present as paraquat dichloride

Applicant name: 4 Farmers Australia Pty Ltd


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



87191



Product name: Titan AMS Liquid Herbicide Adjuvant

Active constituent/s: 417 g/L ammonium sulphate

Applicant name: Titan Ag Pty Ltd


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



88452



Product name: Huilong Methomyl 225 Insecticide

Active constituent/s: 225 g/L methomyl (an anti-cholinesterase compound)

Applicant name: Huilong Agrochemicals Australia Pty Ltd


Summary of use: For the control of insect pests in various crops as specified in the directions for use



88438



Product name: Mozzigear Natural Armour Tropical Strength Insect Repellent Spray

Active constituent/s: 360 g/L oil of lemon eucalyptus (hydrated, cyclized)

Applicant name: Franbar Glen Pty Ltd


Summary of use: For use as a personal insect repellent



88415



Product name: Pacific Glyphosate Potassium Salt 540 SL Herbicide

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

Applicant name: Pacific Agriscience Pty Ltd


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



88450




2. VARIATIONS OF REGISTRATION


Product name: Sharpen WG Herbicide

Active constituent/s: 700 g/kg saflufenacil

Applicant name: BASF Australia Ltd


Summary of use: Variation of product registration and label approval to add additional weeds to the label



62853



Product name: Intake Combi Sapphire In-furrow Fungicide

Active constituent/s: 500 g/L flutriafol

Applicant name: Nufarm Australia Limited


Summary of variation:

To add additional formulations and update the product name

Date of variation: 15 October 2019


66358



Product name: Intake Combi Sapphire In-furrow Fungicide





To register additional approved formulations and update product name



66358



Product name: Intake Combi Sapphire In-Furrow Fungicide





To register additional approved formulations and update product name



66358





Product name: Pronamide Selective Herbicide

Active constituent/s: 500 g/L propyzamide

Applicant name: Amgrow Pty Ltd



To update the product registration and label approval to include additional critical comments for use on turf



66067



Product name: Genfarm Diuron 900WG Herbicide

Active constituent/s: 900 g/kg diuron




To add new uses and vary existing uses as per the reference product



60286



Product name: Rudduck Alpha Rapid Rodenticide

Active constituent/s: 35 g/kg alphachloralose

Applicant name: Rentokil Initial Pty Ltd



To change the distinguishing product name and the name that appears on the label from ‘Rentokil Alpha Rapid Rodenticide’ to ‘Rudduck Alpha Rapid Rodenticide’



62084



Product name: Virkill FarmFluid S Concentrated Disinfectant

Active constituent/s: 419.2 g/L tar acid high boiling, 52.4 g/L cresylic acid

Applicant name: Abbey Laboratories Pty Ltd



To change the distinguishing product name and the name that appears on the label from ‘Abbey FarmFluid S Concentrated Disinfectant’ to ‘Virkill FarmFluid S Concentrated Disinfectant’



88332





Product name: Farmalinx Axyturf-M Fungicide

Active constituent/s: 240 g/L metalaxyl-M




To approve a new label for the product 'Farmalinx Axyturf -M Fungicide' with the label name 'ProForce Solitaire 240 ME Fungicide'



80045



Product name: Titan Diuron 900 WG Herbicide

Active constituent/s: 900 g/kg diuron

Applicant name: Titan Ag Pty Ltd



To add uses in lucerne and pulses and amend the use pattern for sugarcane



62189



Product name: Choice Low Odour Amine 625 Herbicide

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

Applicant name: Grow Choice Pty Limited



To incorporate spray drift instructions from APVMA reconsideration



58915



Product name: Farmalinx Gaff Selective Herbicide

Active constituent/s: 15 g/L diflufenican, 300 g/L MCPA present as the potassium salt, 20 g/L clopyralid present as the potassium salt




To approve a new label for the product 'Farmalinx Gaff Selective Herbicide' with the label name 'Proforce Warhead Trio Herbicide'



70225





Product name: Farmalinx Dimop 375 EC Herbicide

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




To approve a new label for the product 'Farmalinx Dimop 375 EC Herbicide' with the label name 'Proforce Destro 375 Herbicide'



70403



Product name: Genfarm Glufosinate 200 Herbicide

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




Variation of product registrations and labels to add use instructions for blackcurrant, blueberries, green bean (french bean) (field use only), date palms, green tea, native foods, duboisia, pyrethrum, oil tea tree, nursery stock (nonfood), tropical and sub-tropical fruits – inedible peel (including pitaya (dragon fruit), to products containing 200 g/L glufosinate-ammonium



66314



Product name: Surefire Gamma Herbicide

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

Applicant name: PCT Holdings Pty Ltd



Variation of product registrations and labels to add use instructions for blackcurrant, blueberries, green bean (french bean) (field use only), date palms, green tea, native foods, duboisia, pyrethrum, oil tea tree, nursery stock (nonfood), tropical and sub-tropical fruits – inedible peel (including pitaya (dragon fruit), to products containing 200 g/L glufosinate-ammonium



66733



Product name: Armoury Herbicide

Active constituent/s: 150 g/L imazapyr present as the potassium salt, 150 g/L glyphosate present as the potassium salt

Applicant name: Crop Culture Pty Ltd



To make a number of minor text changes to the label



67206





Product name: Easyfarm Tri-allate 500 EC Herbicide

Active constituent/s: 500 g/L triallate, 471 g/L hydrocarbon liquid

Applicant name: Easyfarm Pty Ltd



To correct the withholding periods and resistance warning, and to update the first aid instructions



67425



Product name: Farmalinx Chlornil 720 SC Fungicide

Active constituent/s: 720 g/L chlorothalonil




To approve a new label for the product 'Farmalinx Chlornil 720 SC Fungicide' with the label name 'Proforce Squadron Weatherace 720 SC Fungicide'



65924



Product name: Farmalinx Foset 800 WG Fungicide

Active constituent/s: 800 g/kg fosetyl-aluminium




To approve a new label for the product 'Farmalinx Foset 800 WG Fungicide' with the label name 'ProForce Grenadier 800 WG Fungicide'



80220



Product name: Farmalinx Frontrow 500 SC Herbicide

Active constituent/s: 500 g/L propyzamide, 42 g/L ethylene glycol




To approve a new label for the product 'Farmalinx Frontrow 500 SC Herbicide' with the label name 'Proforce Checkpoint 500 SC Herbicide'



66492




3. VARIATION OF LABEL APPROVAL


Product name: Eezi Pool All-In-One Monthly Pool Care

Active constituent/s: 75 g/kg copper sulfate present as copper sulfate pentahydrate, 650 g/kg chlorine (Cl) present as calcium hypochlorite

Applicant name: Iain Lowe Ta Eezi-pool Australia



To modify the label to clarify the directions for use



81351



Product name: Macspred Glymac Bio 510 Herbicide

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

Applicant name: Macspred Pty Ltd



To make a number of minor variations to the label



83385



Product name: Towelup 2,4-D Herbicide

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







59972



Product name: Choice 2,4-D Ester 680 Herbicide

Active constituent/s: 680 g/L 2,4-D present as the ethyl hexyl ester







66472




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: Dalmazin

Active constituent/s: 75 µg/mL d-cloprostenol

Applicant name: Ethical Agents Australia Pty Limited


Summary of use: For the induction of oestrus in mares, synchronisation or induction of oestrus in cows and induction of parturition in cows and sows. The product is also indicated for the expulsion of mummified foetus, induction of abortion, ovarian dysfunction (persistent corpus luteum, luteal cyst) treatment, endometritis/pyometra and delayed uterine involution treatment in cows



66024


2. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Tilmovet 300 Injection

Active constituent/s: 300 mg/mL tilmicosin

Applicant name: Huvepharma EOOD

Applicant ACN: N/A

Summary of use: For use in lot-fed cattle for treatment of Bovine Respiratory Disease (BRD) associated with Mannheimia (Pasturella) haemolytica, Pasturella multicoda, and other organisms that are susceptible to tilmicosin



87117



Product name: VB12 Plus Selenium For Sheep And Cattle

Active constituent/s: 2 mg/mL hydroxocobalamin as hydroxocobalamin acetate Vitamin B12, 4 mg/mL selenium as sodium selenate



Summary of use: For the treatment and control of vitamin B12 and selenium deficiency in sheep and cattle



88380





Product name: VB12 For Sheep And Cattle

Active constituent/s: 2 mg/mL hydroxocobalamin as hydroxocobalamin acetate Vitamin B12



Summary of use: For treatment and control of vitamin B12 deficiency



88382



Product name: Moximax Moxidectin Oral Drench For Sheep With Selenium

Active constituent/s: 1 mg/mL moxidectin, 0.5 mg/mL selenium as sodium selenate



Summary of use: For use as an oral drench for sheep



88392



Product name: Independents Own Blade Equine Wormer

Active constituent/s: 100 mg/g praziquantel, 8 mg/g ivermectin

Applicant name: The Hunter River Company Pty Limited


Summary of use: For oral use in horses for the treatment and control of roundworms, tapeworms, botsand skin lesions caused by Habronema and Draschia species and Onchocerca species



88466



Product name: Independents Own Essential Oral Paste For Horses

Active constituent/s: 50 mg/mL praziquantel, 4 mg/mL abamectin



Summary of use: For the treatment and control of tapeworms, roundworms, bots and skin lesions caused by Habronema and Draschia species and Onchocerca species microfilariae



88469





Product name: Moximax LA Injectable For Sheep

Active constituent/s: 20 g/L moxidectin



Summary of use: For the treatment and control of roundworms, nasal bot and itchmite in sheep, and protection against severe challenge by Haemonchus contortus (barber's pole worm) for up to four months



88432



Product name: Independents Own Essential Liquid Allwormer Allwormer Tubing Liquid For Horses

Active constituent/s: 10 g/L praziquantel, 0.8 g/L abamectin



Summary of use: For the treatment and control of tapeworms, roundworms, bots and skin lesions caused by Habronema and Draschia species and Onchocerca species microfilariae



88467


3. VARIATIONS OF REGISTRATION


Product name: Nitromec Injection Endectocide and Flukicide for Cattle

Active constituent/s: 340 g/L nitroxynil as eglumine, 67 g/L clorsulon, 6.7 g/L ivermectin

Applicant name: Virbac (Australia) Pty Ltd


Summary of use: To change the distinguishing product name and the name that appears on the label from ‘Virbac Nitromec Injection Endectocide And Flukicide For Cattle’ to ‘Nitromec Injection Endectocide and Flukicide for Cattle’



59844



Product name: Equivac HeV Hendra Virus Vaccine For Horses

Active constituent/s: 100 µg/mL G glycoprotein of Hendra virus (SG-protein)

Applicant name: Zoetis Australia Pty Ltd



To amend the batch release specifications and remove test procedure No 8645



68996





Product name: Independents Own Venus Spray-on Sheep Blowfly Treatment

Active constituent/s: 60 g/L cyromazine




To update the claims, restraints, contraindications, dosage and administration and disposal sections of the label in accordance with the Vet Labelling Code



52745



Product name: Independents Own Venus Liquid Sheep Blowfly Treatment

Active constituent/s: 500 g/L cyromazine




To update claims, contraindications, general directions, withholding period and environmental statements on the label



53023




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: florasulam

Applicant name: Jiangsu Agrochem Laboratory Co Ltd

Applicant ACN: N/A

Summary of use: For use in agricultural chemical products

Date of approval: 21 October 2019

Approval no.: 87855


Active constituent/s: deslorelin acetate

Applicant name: Randlab Australia Pty Ltd


Summary of use: For use in veterinary chemical products


Approval no.: 87931


Active constituent/s: cetrimide

Applicant name: Animal Ethics Pty Ltd




Approval no.: 87937


Active constituent/s: oxfendazole

Applicant name: Randlab Australia Pty Ltd




Approval no.: 87945

2. VARIATIONS OF ACTIVE CONSTITUENT


Active constituent/s: transfluthrin

Applicant name: Agro-Alliance (Australia) Pty Ltd


Summary of use: Variation of relevant particulars or conditions of an approved active constituent


Approval no.: 87400




Active constituent/s: disodium cobalt EDTA

Applicant name: Boehringer Ingelheim Animal Health Australia Pty Ltd




Approval no.: 83626


Active constituent/s: ceftiofur hydrochloride

Applicant name: Zoetis Australia Pty Ltd




Approval no.: 83178



New Chemical Product: Vedira suite of products containing the new active broflanilide

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it applications for registration of a suite of new products containing the new active constituent broflanilide.

PARTICULARS OF THE APPLICATIONS

Applicant company: BASF AUSTRALIA PTY LTD

Name of active constituent: Broflanilide

Signal heading (all products): Schedule 5

Proposed product name(s)

Concentration of broflanilide

Pack sizes Formulation type

Summary of proposed use

Vedira Granular Fly Bait

0.25 g/kg 100 g, 200 g, 300 g, 400 g, 450 g, 454 g, 500 g, 680 g, 700 g, 800 g, 900 g, 1 kg, 2 kg, 5 kg

Ready to use bait

For the control of flies in commercial, industrial, agricultural and domestic situations

Vedira Granular Ant Bait

0.05 g/kg 100g, 200g, 300g, 400g, 450 g, 454 g, 500 g, 680 g, 1 kg, 5 kg, 11.34 kg

Ready to use bait

For the control of ants in commercial, industrial, agricultural and domestic situations

Vedira Pressurised Bait

1.25 g/kg 400g, 454 g, 500g, 567g, 600g

Aerosol foam Spot treatment in the control of flies, cockroaches and house ants in commercial, industrial and agricultural situations

Vedira Gel Cockroach Bait

2.5 g/kg 1 x 20 g, 1 x 25 g, 1 x 30 g, 1 x 35 g, 2 x 20 g, 2 x 25 g, 2 x 30 g, 2 x 35 g, 4 x 20 g, 4 x 25 g, 4 x 30 g, 4 x 35 g

Ready to use bait

Crevice, crack or spot treatment control of cockroaches in domestic, commercial and public service buildings

Vedira Gel Ant Bait

0.2 g/kg 20g, 25g, 30g, 35g, 2 x 20g, 2 x 25g, 2 x 30g, 2 x 35g, 4 x 20g, 4 x 25g, 4 x 30g, 4 x 35g

Ready to use bait

Crevice, crack or spot treatment control of ants in and around domestic, commercial and industrial buildings

Vedira Pressurised Insecticide

2 g/kg

AND

0.5 g/kg alpha-cypermethrin

400 g, 454 g, 500 g, 567 g, 600 g

Aerosol For crack and crevice treatment control of ants, cockroaches, stored product pests, bed bugs, silverfish, flies, house crickets, paper wasps and spiders

Terinda Foam Termiticide & Insecticide

0.045 g/kg 454 g, 500 g, 567 g Aerosol foam For control of existing infestations of subterranean termites, drywood termites and



Proposed product name(s)

Concentration of broflanilide

Pack sizes Formulation type

Summary of proposed use

carpenter ants in commercial, industrial and public health situations

SUMMARY OF THE APVMA’S EVALUATION OF VEDIRA SUITE OF PRODUCTS 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 applications 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 ALL PRODUCTS 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 ALL PRODUCTS 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 ALL PRODUCTS containing the active constituent broflanilide 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 ALL PRODUCTS is not likely to have an unintended effect that is harmful to animals, plants 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 labels directions, the products are effective for their proposed uses.

3. The APVMA has evaluated the applications 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:

(ii) The APVMA is satisfied that the proposed use of ALL PRODUCTS would not adversely affect trade between Australia and places outside Australia.

FURTHER INFORMATION

A Public Release Summary (PRS) of the evaluation of these products is available from the APVMA website’s ‘Public Consultation’ page, or by contacting the APVMA as listed below.

MAKING A SUBMISSION

In accordance with section 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the products 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.


https://apvma.gov.au/news-and-publications/public-consultations



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.

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

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

Written submissions should be addressed in writing to:

Case Management and Administration Unit

Australian Pesticides and Veterinary Medicines AuthorityGPO Box 3262SYDNEY NSW 2001 Australia

Phone: +61 2 6770 2300

Email: [email protected]



New Active Constituent: Broflanilide

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new active constituent, broflanilide. Broflanilide is a meta-diamide insecticide for controlling social insects and non-social solitary or gregarious insects, such as, ants, wasps, termites and cockroaches. Particulars of the Active Constituent

Common name: Broflanilide

IUPAC name: N-[2-Bromo-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)-6-(trifluoromethyl)phenyl]-2-fluoro-3-(N-methylbenzamido)benzamide

CAS name: 3-(Benzoylmethylamino)-N-[2-bromo-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]-6-(trifluoromethyl)phenyl]-2-fluorobenzamide

CAS registry number: 1207727-04-5

Manufacturer’s codes: MCI-8007 (BAS 450 I)

Minimum purity: 966.8 g/kg

Molecular formula: C25H14BrF11N2O2

Molecular weight: 663.3 g.mol-1

Structure:

Chemical family: Meta-diamide

Mode of action: Broflanilide is a meta-diamide insecticide, which is metabolized to desmethyl-broflanilide to act as a noncompetitive resistant-to-dieldrin (RDL) γ-aminobutyric acid (GABA) receptor antagonist.

SUMMARY OF THE APVMA’S EVALUATION OF BROFLANILIDE ACTIVE CONSTITUENT

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

An Acceptable Daily Intake (ADI) and an Acute Reference Dose (ARfD) have not been set noting that the proposed use patterns do not involve uses on food crops.

No toxicologically significant impurities have been identified in technical broflanilide.

New Active Consitutent: Broflanilide


A delegate to the Secretary of the Department of Health has made an interim decision to amend the Poisons Standard in relation to broflanilide as follows:

A new entry will be made to Schedule 6 to include BROFLANILIDE except when included in Schedule 5. A new entry will be made to Schedule 5 to include BROFLANILIDE in preparations containing 0.3 per cent or less of broflanilide. If the above scheduling recommendations are adopted as final, all of the proposed end-use-products would be captured by the Schedule 5 entry.

The final decision of the scheduling delegate is to be published on 28 November 2019.

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

Specification Level

Broflanilide Minimum 965 g/kg

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

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

FURTHER INFORMATION

A Public Release Summary (PRS) of the evaluations of the active and seven products is available from the APVMA website’s ‘Public Consultation’ page.

MAKING A SUBMISSION

In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether broflanilide should be approved. 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 the date you made the submission.

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

Written submissions should be addressed in writing to:

Case Management and Administration Unit

Australian Pesticides and Veterinary Medicines AuthorityGPO Box 3262SYNDEY NSW 2001




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


APVMA Gazette No. 22, 5 November 2019€¦ · Web viewand skin lesions caused by Habronema and Draschia species and Onchocerca species Date of registration: 24 October 2019 Product

Documents