apvma gazette no. 20, 08 october 2019 · web view000 049 427 summary of variation: to change the...

Gazette Agricultural andVeterinary Chemicals

No. APVMA 20, Tuesday, 8 October 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

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Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

Sydney NSW 2001

Email: [email protected]

Website: apvma.gov.au

GENERAL INFORMATION

The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of

the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as required

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

issued by the APVMA.

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

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

quarterly statistical reports.

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Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 8 October 2019 Agricultural and Veterinary Chemicals Code Act 1994

CONTENTS

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

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

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

Suspension of 2,4-D Active Constituent Approval No. 68950...............................................................................................

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

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

New Chemical Products Luximax Herbicide containing cinmethylin.....................................................................................


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. RESTRICTED PRODUCT

Application no.: 117422

Product name: CPE PAPP Fox Capsules

Active constituent/s: 980 mg/g para-aminopropiophenone

Applicant name: Animal Control Technologies (Australia) Pty Ltd

Applicant ACN: 137 868 449

Summary of use: For reduction in fox numbers

Date of registration: 25 September 2019

Product registration no.:

87036

Label approval no.: 87036/117422


Product name: CPE PAPP Wild Dog Capsules

Active constituent/s: 980 mg/g para-aminopropiophenone

Applicant name: Animal Control Technologies (Australia) Pty Ltd


Summary of use: For reduction in wild dog numbers



87033


2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Tri-form 80 Soil Fumigant

Active constituent/s: 795 g/kg chloropicrin, 195 g/kg 1,3-dichloropropene

Applicant name: Trical Australia Pty Ltd


Summary of use: To approve a new label for the product 'TRI-FORM 80 SOIL FUMIGANT' with the label name 'STRIKE 80 SOIL FUMIGANT'



70117





Product name: Imtrade Dalbie 800 WG Fungicide

Active constituent/s: 800 g/kg prothioconazole

Applicant name: Imtrade Australia Pty Ltd


Summary of use: For the control of various diseases in peanuts as specified in the Directions for Use table



87492



Product name: Amgrow Naturals Weed Terminator RTU

Active constituent/s: 90 g/L acetic acid

Applicant name: Amgrow Pty Ltd


Summary of use: For the control of weeds in gardens, paths, driveways, around sheds and spot spraying in lawns and turf; also controls moss and algae



88254



Product name: Campbell Shadow Ultra Plant Growth Regulator

Active constituent/s: 120 g/L trinexapac-ethyl

Applicant name: Colin Campbell (Chemicals) Pty Ltd


Summary of use: For the regulation of leaf and stem growth of grass species and as an aid in turf management



88267



Product name: Sabakem Prosulfocarb 800EC Herbicide

Active constituent/s: 800 g/L prosulfocarb

Applicant name: Sabakem Pty Ltd


Summary of use: For the control of annual ryegrass in wheat and barley



87618



Product name: Apparent Fipronil 800 WG Insecticide

Active constituent/s: 800 g/kg fipronil

Applicant name: Apparent Pty Ltd


Summary of use: For the control of various insect pests in bananas, brassicas, cotton, wine grapevines, potatoes and sugarcane



88184





Product name: Weed Force Evict 540 Potassium Salt Herbicide

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

Applicant name: Weed Force Pty Ltd


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



88178



Product name: Greenzone Termite Management Film

Active constituent/s: 1 g/kg bifenthrin

Applicant name: PC Plastics Pty Ltd


Summary of use: For the protection of structures from concealed termite entry



88186



Product name: Titan Metalaxyl 50G Granular Systemic Fungicide

Active constituent/s: 50 g/kg metalaxyl

Applicant name: Titan Ag Pty Ltd


Summary of use: For the control of phytophthora root rot of avocados, phytophthora root rot and trunk canker of macadamia nuts, phytophthora trunk rot of peaches and damping off of certain vegetable crops



88207



Product name: Titan Metalaxyl 250 EC Systemic Fungicide

Active constituent/s: 250 g/L metalaxyl



Summary of use: For the control of phytophthora root rot and heart rot in pineapples



88211



Product name: Conquest Stalwart 150 EC Insecticide

Active constituent/s: 150 g/L s-indoxacarb

Applicant name: Conquest Crop Protection Pty Ltd


Summary of use: For the control of various species of insect pests in cotton



87447





Product name: Rid Australia Rid Insect Repellent Tropical Strength Roll-on 6 Hours Mosquito Protection Neutral Scent Protection Against Mosquitoes That May Carry Ross River Virus And Dengue

Active constituent/s: 191 g/L n,n-diethly-m-toluamide, 40 g/L n-octyl bicycloheptene dicarboximide, 20 g/L di-n-propyl isocinchomeronate

Applicant name: Cavalieri Investing Pty Ltd


Summary of variation:

To approve a new label for the product 'Rid Australia Rid Insect Repellent Tropical Strength Roll-on 6 Hours Mosquito Protection Neutral Scent Protection Against Mosquitoes That May Carry Ross River Virus and Dengue' with the label name 'REPELLEX ® PERSONAL INSECT REPELLENT TROPICAL STRENGTH PROTECTS AGAINST MOSQUITOES, FLIES, TICKS, FLEAS, LEECHES, SANDFLIES, BITING MIDGE 6 HOURS MOSQUITO PROTECTION'

Date of variation: 24 September 2019


84614



Product name: DYNASTY PD Fungicide Seed Treatment

Active constituent/s: 32 g/kg azoxystrobin, 20 g/kg fludioxonil, 4 g/kg metalaxyl-m

Applicant name: Syngenta Australia Pty Ltd


Summary of use: Dry seed treatment product for control of soil and seed borne diseases in peanuts



86643



Product name: Termidor HP II Residual Termiticide

Active constituent/s: 96 g/L fipronil

Applicant name: BASF Australia Ltd


Summary of use: For the control of subterranean termites around domestic and commercial structures as specified in the Directions for Use Table. To be used by licensed pest control operators only. To be used in conjunction with the Termidor HP injection system



87825



Product name: IA Triallate 625 EC Herbicide

Active constituent/s: 625 g/L triallate

Applicant name: Imtrade Australia Pty Ltd


Summary of use: For the control of wild oats in wheat, triticale, chickpeas, barley, peas, linseed, lupins, canola (rapeseed), faba beans and safflower



88293





Product name: Garden Basics Insect and Pest Spray

Active constituent/s: 0.1 g/L tau-fluvalinate, 0.05 g/L myclobutanil

Applicant name: Pinegro Products Proprietary Limited


Summary of use: For systemic control of black spot, powdery mildew and rust. Kills aphids, thrips, caterpillars, budworm and mites on roses and ornamentals



87982



Product name: Spalding Camouflage Selective Herbicide

Active constituent/s: 500 g/L 2,4-DB present as the dimethylamine salt

Applicant name: Spalding Holdings Pty Ltd


Summary of use: For the control of broadleaf weeds in seedling and established lucerne, medic and clover pastures, peanuts and cereal crops undersown with lucerne, medic or sub-clover



88304



Product name: Alkakleen Concentrated Low Foam Alkaline Cleaner

Active constituent/s: 399 g/L sodium hydroxide

Applicant name: IWTS Group Pty Ltd


Summary of use: For use as a concentrated low foaming alkaline detergent for removal of stubborn soils for use in most automatic wash systems where liquids are preferred



88092



Product name: Garden Basics Rose Spray

Active constituent/s: 0.1 g/L tau-fluvalinate, 0.05 g/L myclobutanil

Applicant name: Pinegro Products Proprietary Limited


Summary of use: For systemic control of black spot, powdery mildew and rust. Kills aphids, thrips, caterpillars, budworm, and mites on roses and ornamentals



87984





Product name: Copprex Fungicide

Active constituent/s: 350 g/kg copper present as copper oxychloride, 150 g/kg metalaxyl

Applicant name: Sanonda (Australia) Pty Ltd


Summary of use: For control of downy mildew on grapevines, and phytophthora trunk canker and root rot of macadamia nuts



87998


3. VARIATIONS OF REGISTRATION


Product name: Yates Buffalo Pro Lawn Weedkiller Bindi & Clover Hose-on

Active constituent/s: 6 g/L bromoxynil present as the potassium salt, 6 g/L MCPA present as the potassium salt

Applicant name: Duluxgroup (Australia) Pty Ltd



To change the distinguishing product name and the name that appears on the label from ‘Yates Buffalo Pro Bindii & Broadleaf Weed Killer Hose-On’ to ‘Yates Buffalo Pro Lawn Weedkiller Bindi & Clover Hose-on’



63008



Product name: Genfarm 2,4-D LV Ester 680 Herbicide

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

Applicant name: Landmark Operations Limited



To add the restraints required as per the review of 2,4-D



62684



Product name: Genfarm 2,4-D Amine 625 Herbicide

Active constituent/s: 625 g/L 2,4-D present as the dimethyl amine salt

Applicant name: Landmark Operations Limited



To add the restraints required as per the review of 2,4-D



63271





Product name: Eureka! Triadimefon 125 EC Fungicide

Active constituent/s: 125 g/L triadimefon

Applicant name: Eureka! Agresearch Pty Ltd



To vary the label to include scheduled excipient polyethanoxy (15) tallow amine in the constituents statement of the product label



80874



Product name: Imbrex Fungicide

Active constituent/s: 62.5 g/L fluxapyroxad




To vary the label to include scheduled excipients, N,N-dimethyloctanamide and N,N-dimethyldecanamide in the constituents statements of the product label and update the signal heading to ‘POISON’ on the product label and update the PubCRIS database to include the correct scheduling



64104



Product name: F.S.A. Spraying Oil

Active constituent/s: 582 g/L paraffinic oil, 120 g/L nonyl phenol ethoxylate, 120 g/L alcohol ethoxylate

Applicant name: Four Seasons Agribusiness Pty Ltd



To change the distinguishing product name and the name that appears on the label from ‘F.S.A. Spraying Oil Adjuvant’ to ‘F.S.A. Spraying Oil’



87386



Product name: AW Muffle 480 SC Herbicide

Active constituent/s: 480 g/L metribuzin

Applicant name: Agri West Pty Limited



To vary the label to update the scheduling of the active metribuzin to ‘POISON’



63372





Product name: Timorex Gold Fungicide

Active constituent/s: 222 g/L tea tree oil

Applicant name: Stockton (Israel) Ltd

Applicant ACN: N/A


To extend the use to include control of powdery mildew and botrytis in grape vines and to amend the use rate in currently registered crops



63549



Product name: Versys Insecticide

Active constituent/s: 100 g/L afidopyropen




To modify the restraints to allow use in ornamental crops grown in a protected cropping situations



82738



Product name: Sky-7th 200 Herbicide

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

Applicant name: Grow Choice Pty Limited



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)



66397



Product name: Crop Culture Azoxy 250 Fungicide

Active constituent/s: 250 g/L azoxystrobin

Applicant name: Crop Culture Pty Ltd



To add a number of additional claims to the label



66927





Product name: Eliminate Herbicide

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




To add uses in Pinus radiata and Eucalyptus plantation forestry



66088



Product name: Agro-Essence Glufosinate 200 Herbicide


Applicant name: Agro-Alliance (Australia) Pty Ltd



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)



67619



Product name: Guillotine Herbicide





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)



65157



Product name: Accensi Glufosinate-Ammonium Herbicide


Applicant name: Accensi Pty Ltd



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)



68603





Product name: Apparent Dingo 500 Insecticide

Active constituent/s: 500 g/L chlorpyrifos

Applicant name: Apparent Pty Ltd



To amend the product label in line with the regulatory decision relating to chlorpyrifos home garden and domestic pest control uses



65160



Product name: Fumithor Delta Insecticide Smoke Generator

Active constituent/s: 20 g/kg deltamethrin

Applicant name: Ensystex Australasia Pty Ltd



To include an additional use for control of bed bugs



70128



Product name: Yates Buffalo Pro Lawn Weedkiller Bindii & Clover Hose-on

Active constituent/s: 6 g/L bromoxynil present as the potassium salt, 6 g/L MCPA present as the potassium salt

Applicant name: Duluxgroup (Australia) Pty Ltd



To change the distinguishing product name and the name that appears on the label from ‘Yates Buffalo Pro Lawn Weedkiller Bindi & Clover Hose-on’ to ‘Yates Buffalo Pro Lawn Weedkiller Bindii & Clover Hose-on’



63008



Product name: Kenso Agcare Taekwando 250 CS Insecticide

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

Applicant name: Kenso Corporation (M) Sdn Bhd

Applicant ACN: N/A


To include uses in brassicas, citrus, onions, potatoes and tomatoes



85948





Product name: Conquest Pro 500 In-furrow Fungicide

Active constituent/s: 500 g/L flutriafol

Applicant name: Conquest Crop Protection Pty Ltd



To add a new application method and vary the product name to ‘Conquest Pro 500 In- Furrow Fungicide’



80012



Product name: Titan Glufosinate 200 Herbicide





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)



66364


4. VARIATION OF LABEL APPROVAL


Product name: Sharda Fipronil 200 SC Insecticide

Active constituent/s: 200 g/L fipronil

Applicant name: Sharda Cropchem Espana SL

Applicant ACN: N/A


To correct an error in the application rate for forestry plantations



83387



Product name: F.S.A. Sulfosulfuron 750WG Herbicide

Active constituent/s: 680 g/kg glyphosate present as the mono-ammonium salt

Applicant name: Four Seasons Agribusiness Pty Ltd



To incorporate crop rotation and crop safety instructions from APVMA reconsiderations



87121





Product name: Set-up Dry 680 Herbicide

Active constituent/s: 680 g/kg glyphosate present as the mono-ammonium salt

Applicant name: Imaspro Resources Sdn Bhd

Applicant ACN: N/A


To vary the label to include scheduled excipient polyethanoxy (15) tallow amine in the constituents statement



63128




Veterinary Chemical Products and Approved Labels

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Pharmasin 200 mg/mL Solution for Injection

Active constituent/s: 200 mg/mL tylosin

Applicant name: Huvepharma EOOD

Applicant ACN: N/A

Summary of use: For the treatment of tylosin susceptible bacterial and mycoplasmal infections in cattle and pigs



87518


2. VARIATIONS OF REGISTRATION


Product name: UniPRBC Canine

Active constituent/s: 500 - 550 mL/L Canine Erythrocytes (RBC)

Applicant name: Plasvacc Pty Ltd


Summary of use: To alter the nutrient solution, change expiry date, change the pack size and align the label to the current Vet Labelling Code and to the nominated reference product



60275



Product name: Eradicator Pour-on Blowfly Strike Prevention and Lousicide for Sheep

Active constituent/s: 35 g/L imidacloprid

Applicant name: Jurox Pty Limited



To add new target species and to vary the name of the registered product



81540




3. VARIATION OF LABEL APPROVAL


Product name: Imax Cd Pour-On for Cattle

Active constituent/s: 10 mg/mL ivermectin

Applicant name: Bayer Australia Ltd (Animal Health)



To correct label actives, include a schedule 5 solvent and amend first aid and safety directions



59344



Product name: Biomectin Pour-On for Cattle








62048



Product name: Lignomav 20mg/mL Local Anaesthetic

Active constituent/s: 17.2 mg/mL lignocaine (present as 20 mg/mL lignocaine hydrochloride)

Applicant name: Mavlab Pty Ltd



To extend product use in sheep and pigs



37429



Product name: Felimazole 2.5 mg Coated Tablet

Active constituent/s: 2.5 mg/Tb thiamazole (methimazole)

Applicant name: Dermcare-Vet Pty Ltd



To amend the storage statement



63927





Product name: Felimazole 5 mg Coated Tablet

Active constituent/s: 5 mg/Tb thiamazole (methimazole)

Applicant name: Dermcare-Vet Pty Ltd



To amend the storage statement



63928



Product name: Top End Mectin Pour-on For Cattle








65017



Product name: Coopers Sovereign Pour-on Flukicide and Anthelmintic for Cattle

Active constituent/s: 240 g/L triclabendazole, 15 g/L ivermectin

Applicant name: Intervet Australia Pty Limited



To amend first aid instructions and safety directions



58611



Product name: Vetsense Permetrol Insecticidal Spray and Rinse Concentrate for Dogs and Horses

Active constituent/s: 40 g/L permethrin (25:75 cis:trans)

Applicant name: Vetsense Pty Ltd



To amend first aid instructions and safety directions



60919





Product name: Ovu-mate Oral Progestagen to Regulate Oestrus in Horses

Active constituent/s: 2.2 mg/mL altrenogest

Applicant name: Randlab Australia Pty Ltd



To add an additional 2 L pack size



65653



Product name: Virbac Virbamec Pour-on Endectocide for Cattle

Active constituent/s: 5 mg/mL abamectin

Applicant name: Virbac (Australia) Pty Ltd






56753



Product name: Selpor Selenium Pour-on for Cattle

Active constituent/s: 5 g/L selenium as sodium selenite




To update a solvent constituent, safety directions and First Aid sections



47057




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:

d-allethrin

Applicant name: Endura SPA

Applicant ACN: N/A

Summary of use: For use in agricultural chemical products

Date of approval: 18 September 2019

Approval no.: 87686



diquat dibromide

Applicant name: Agrogill Chemicals Pty Ltd




Approval no.: 87160



benzovindiflupyr

Applicant name: Syngenta Australia Pty Ltd




Approval no.: 86309



paraquat dichloride

Applicant name: Agrogill Chemicals Pty Ltd




Approval no.: 87171



prochloraz

Applicant name: Stotras Pty Ltd




Approval no.: 87675





sodium selenite

Applicant name: Vetpharm Pty Limited


Summary of use: For use in veterinary chemical products


Approval no.: 87835



meloxicam

Applicant name: Alberta Veterinary Laboratories Ltd

Applicant ACN: N/A



Approval no.: 87801



meloxicam

Applicant name: Le Vet Beheer B V

Applicant ACN: N/A



Approval no.: 87888



hexazinone

Applicant name: Jiangsu Lanfeng Biochemical Co Ltd

Applicant ACN: N/A



Approval no.: 87682



bifenthrin

Applicant name: Jiangsu ChunjiangRun Tian Agrochemical Co Ltd

Applicant ACN: N/A



Approval no.: 87766



amoxicillin trihydrate

Applicant name: South Yarra Pharma Pty Ltd




Approval no.: 87889



2. VARIATIONS OF ACTIVE CONSTITUENT


Active constituent/s: sodium selenite



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


Approval no.: 83575


Active constituent/s: milbemycin oxime

Applicant name: Elanco Australasia Pty Ltd


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


Approval no.: 55841



Suspension of 2,4-D Active Constituent Approval No. 68950

The APVMA has suspended the following 2,4-D active constituent approval:

Table 1: Suspended 2,4-D active constituent approval

Approval No. Approval Holder

68950 Kingtai Chemicals Co., Limited

The suspension of 2,4-D active constituent approval No. 68950 is in effect from 8 October 2019 until 8 October 2020. The APVMA also declares that section 45B(2) of the Code ceases to apply in respect of the suspension of 2,4-D active constituent approval No. 68950 and thereby brings the deemed permit under section 45B(1) of the Code to an end.

REASONS

The reasons for the suspension of 2,4-D active constituent approval No. 68950 are:

On 23 March 2018 the APVMA issued all holders of active constituents containing 2,4-D a notice under section 33 of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (Code). The holder has failed to supply, without reasonable excuse, chemical analytical data on the dioxin and dioxin-like impurity content for 2,4-D active constituent approval No. 68950 as required under the notice.

Based on the above, the APVMA is suspending the approval of 2,4-D active constituent approval No. 68950 in accordance with section 38 of the Code.

There are no instructions for the supply, possession, custody or use of 2,4-D active constituent approval No. 68950 since the supply, possession, custody or use of 2,4-D active constituent approval No. 68950 is prohibited.

WARNING

2,4-D active constituent approval No. 68950 is not approved and any associated products are unregistered and any associated labels are not approved during the period of suspension. A person must not possess with the intent to supply, or deal with, have custody of, or use 2,4-D active constituent approval No. 68950 or any products containing 2,4-D active constituent approval No. 68950 during this period. A failure to comply with the suspension will result in an offence against the Agvet Codes and the APVMA will take appropriate compliance action. It is an offence for any person to possess with the intent to supply, or deal with, have custody of or use 2,4-D active constituent approval No. 68950 after 8 October 2019.

APVMA CONTACT

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

Chemical Review

Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

SYDNEY NSW 2001

Phone: +61 2 6700 2400Email: [email protected]

Suspension of 2,4-D Active Constituent Approval No. 68950

mailto:[email protected]

Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 8 October 2019. Agricultural and Veterinary Chemicals Code Act 1994 24

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 Instrument No. 4 (MRL Standard) 2012. 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 Instrument No. 4 (MRL Standard) Amendment Instrument 2019 (No. 2).

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 legislation.gov.au/Series/F2019L01105

For further information please contact:

MRL Contact Officer Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

SYDNEY NSW 2001


Amendments to the APVMA MRL Standard

https://edrms/id:A147213/document/versions/[email protected]


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

In the previous notice on page 24 of APVMA Gazette No. 20, 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 Instrument No. 4 (MRL Standard) Amendment Instrument 2019 (No. 2)) 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.

FSANZ will make a Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO).

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 (8 October 2019)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: Cinmethylin

Permitted residue: CinmethylinEdible offal (mammalian) *0.01Eggs *0.01Meat (mammalian) *0.01Milks *0.01Poultry, edible offal of *0.01Poultry meat *0.01Wheat *0.01

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

Agvet chemical: Bixafen

Permitted residue—commodities of plant origin: BixafenPermitted residue—commodities of animal origin: Sum of bixafen and N-(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1H-pyrazole-4-carboxamide (bixafen-desmethyl), expressed as bixafenOilseed *0.01

Agvet chemical: Dithiocarbamates

Permitted residue: Total dithiocarbamates, determined as carbon disulphide evolved during acid digestion and expressed as milligrams of carbon disulphide per kilogram of food

Olives T2

Agvet chemical: Indoxacarb

Permitted residue: Sum of indoxacarb and its R-isomer

Chervil T10Leafy vegetables [except chervil; lettuce, head; mizuna; rucola]

5

Mizuna T10Rucola (rocket) T20



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

Agvet chemical: Afidopyropen

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

Carrot T*0.01

Agvet chemical: Bixafen

Permitted residue—commodities of plant origin: BixafenPermitted residue—commodities of animal origin: Sum of bixafen and N-(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1H-pyrazole-4-carboxamide (bixafen-desmethyl), expressed as bixafen

Cotton seed T0.3Cotton seed oil, crude T0.5Oilseed [except cotton seed] *0.01

Agvet chemical: Dithiocarbamates

Permitted residue: Total dithiocarbamates, determined as carbon disulphide evolved during acid digestion and expressed as milligrams of carbon disulphide per kilogram of foodOlives for oil production T30Table olives T30

Agvet chemical: Etofenprox

Permitted residue: EtofenproxEdible offal (mammalian) *0.01Eggs *0.01Meat (mammalian) (in the fat) *0.01Milks *0.01Poultry, edible offal of *0.01Poultry meat (in the fat) *0.01Stone fruits [except cherries] 5

Agvet chemical: Etoxazole

Permitted residue: Etoxazole

Passionfruit T0.1




Permitted residue: Sum of indoxacarb and its R-isomerFennel, leaf 5Fruiting vegetables, cucurbits 0.2Leafy vegetables [except lettuce, head] 5

Agvet chemical: Iprodione

Permitted residue: Iprodione

Beetroot leaves T20Chicory leaves T20Cucumber T0.5Endive T20

Agvet chemical: Prothioconazole

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

Cotton seed T0.2

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

Agvet chemical: Amoxycillin

Permitted residue: Inhibitory substance, identified as amoxycillin

Eggs 0.05

Agvet chemical: Emamectin

Permitted residue: Sum of emamectin B1a and emamectin B1b

Leafy vegetables [except lettuce, head and lettuce, leaf]

T0.5



Agvet chemical: Imidacloprid

Permitted residue: Sum of imidacloprid and metabolites containing the 6-chloropyridinylmethylene moiety, expressed as imidaclopridPodded pea (young pods) (snow and sugar snap)

T0.2


Permitted residue: Sum of indoxacarb and its R-isomer

Asparagus *0.01Celery 3Cherries 1Edible offal (mammalian) [except kidney]

0.02

Kidney (mammalian) 0.5Meat (mammalian) (in the fat) 3Milk fats 2Tomato 0.2



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) 5 November 2019

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.

For further information please contact:

MRL Contact Officer Australian Pesticides and Veterinary Medicines Authority

GPO Box 3262

SYDNEY NSW 2001




Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 8 October 2019. Agricultural and Veterinary Chemicals Code Act 1994

New Chemical Products Luximax Herbicide containing cinmethylin

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 LUXIMAX HERBICIDE.

PARTICULARS OF THE APPLICATION

Proposed product name(s):

Luximax Herbicide

Applicant company: BASF AUSTRALIA LTD

Name of active constituent:

cinmethylin

Signal heading: Schedule 5

Summary of proposed use:

For the pre-emergence control of annual ryegrass (Lolium rigidum) and suppression of certain grass weeds in wheat (not durum wheat).

Pack sizes: 10L, 20L, 110L, 1000L

Withholding period: HARVEST: NOT REQUIRED WHEN USED AS DIRECTED

GRAZING: DO NOT GRAZE OR CUT FOR STOCK FOOD FOR 7 WEEKS AFTER APPLICATION.

SUMMARY OF THE APVMA’S EVALUATION OF LUXIMAX 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 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 Luximax Herbicide 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 Luximax Herbicide 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 Luximax Herbicide containing the active constituent cinmethylin 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 Luximax Herbicide 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:


Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 8 October 2019. Agricultural and Veterinary Chemicals Code Act 1994

(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:

(ii) The APVMA is considering whether the proposed use of Luximax Herbicide would not adversely affect trade between Australia and places outside Australia.

FURTHER INFORMATION

A Public Release Summary (PRS) of the evaluation of this product 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 Luximax 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.

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



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

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

apvma gazette no. 20, 08 october 2019 · web view000 049 427 summary of variation: to change the...

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