APVMA Gazette No. 14, 14 July 2020 · Web viewEurovet Animal Health BV Applicant ACN: N/A Summary of variation: To extend uses in large breed of dogs with preclinical dilated cardiomyopathy

Gazette Agricultural andVeterinary Chemicals

No. APVMA 14, Tuesday, 14 July 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

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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 14, Tuesday, 14 July 2020 Agricultural and Veterinary Chemicals Code Act 1994

CONTENTS

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

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

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

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

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

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

Notice of Cancellation at the Request of the Holder..............................................................................................................


Agricultural Chemical Products and Approved Labels

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

1. RESTRICTED PRODUCT

Application no.: 125195

Product name: Flexi Collars Termite Protection Barrier

Active constituent/s: 1g/kg bifenthrin

Applicant name: FMC Australasia Pty Ltd

Applicant ACN: 095 326 891

Summary of variation:

To approve a new label for the product 'Flexi Collars Termite Protection Barrier' with the label name 'Homeguard Flexicollar Termite Protection Barrier'

Date of variation: 24 June 2020

Product registration no.:

64393

Label approval no.: 64393/125195

2. AGRICULTURAL PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS


Product name: Ecothor Active Nature Cellmesh Insecticide

Active constituent/s: 37 g/L hydroxypropyl methylcellulose

Applicant name: Ensystex Australasia Pty Ltd


Summary of use: For control of a range of insect pests in urban and rural situations

Date of registration: 2 July 2020


87721



Product name: SCAL 5169 CIK

Active constituent/s: 2.0 g/kg d-phenothrin, 1.0 g/kg momfluorothrin

Applicant name: Sumitomo Chemical Australia Pty Ltd


Summary of use: For the control of crawling insects in a home and garden situation



86714


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



Product name: PestXpert DIY Like The Professionals Pro Spray Rapid Knockdown Flying Insect Killer

Active constituent/s: 2.0 g/kg d-phenothrin, 1.0 g/kg momfluorothrin

Applicant name: Sumitomo Chemical Australia Pty Ltd


Summary of use: For the control of flying insects



86704


3. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Mortein Powergard Flying Crawling All In One Insect Killer Germs Fragrance Free

Active constituent/s: 1.2 g/kg esbiothrin, 0.5 g/kg permethrin, 0.2 g/kg imiprothrin

Applicant name: RB (Hygiene Home) Australia Pty Ltd


Summary of use: To kill flying and crawling insects and the germs they carry

Date of registration: 22 June 2020


89130



Product name: Mortein Powergard Flying Crawling All In One Insect Killer Germs Eucalyptus

Active constituent/s: 1.2 g/kg esbiothrin, 0.5 g/kg permethrin, 0.2 g/kg imiprothrin

Applicant name: RB (Hygiene Home) Australia Pty Ltd


Summary of use: To kill flying and crawling insects and the germs they carry



89128



Product name: Antifouling SeaForce Active Plus

Active constituent/s: 432 g/L copper as cuprous oxide, 85 g/L Zineb, 24 g/L copper pyrithione

Applicant name: Jotun Australia Pty Ltd


Summary of use: For control of marine growth below the waterline on vessels



87840





Product name: Prizm Industrial Herbicide

Active constituent/s: 880 g/kg terbacil, 40 g/kg sulfometuron methyl

Applicant name: EnviroMint Ltd

Applicant ACN: N/A

Summary of use: For control of certain annual and perennial weeds in commercial and industrial areas



89240



Product name: Farmalinx Bingo ME 120 Growth Regulator

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

Applicant name: Farmalinx Pty Ltd


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



89394



Product name: TRS Flying Insect Killer

Active constituent/s: 1.1 g/kg esbiothrin, 0.5g/kg permethrin

Applicant name: Pascoe's Pty Ltd


Summary of use: For control of flying insects



89631



Product name: Wild Wonderer Insect Shield Apparel and Gear

Active constituent/s: 5.2 g/kg permethrin

Applicant name: Beach To Bush Outdoor Clothing Pty Ltd


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



89166





Product name: Salve Herbicide

Active constituent/s: 375 g/kg aminopyralid present as the potassium salt, 300 g/kg metsulfuron-methyl

Applicant name: Grow Choice Pty Ltd


Summary of use: For the control of weeds in pastures, non-agricultural areas, commercial and industrial areas, and rights-of-way



88260



Product name: Rid Australia Rid Insect Repellent Tropical Strength Spray 6 Hour Mosquito Protection

Active constituent/s: 191 g/kg diethyltoluamide, 40 g/kg N-octyl bicycloheptene dicarboximide

Applicant name: Cavalieri Investing Pty Ltd


Summary of use: For 6 hour tropical strength protection against mosquitoes. Repels mosquitoes, flies, sandflies, ticks, leeches, fleas and other annoying biting insects



89385



Product name: Dualquat-10 Sanitiser

Active constituent/s: 100 g/L quaternary ammonium compounds

Applicant name: IWTS Group Pty Ltd


Summary of use: For use as a broad-spectrum disinfectant to disinfect pre-cleaned surfaces on poultry, pig, dairy and vegetable farms



89404



Product name: Devastate Plus Glyphosate 580 Herbicide

Active constituent/s: 580 g/L glyphosate (present as the potassium and monoethanolamine salts)

Applicant name: Tollman Pty Ltd


Summary of use: For non-selective control of many annual and perennial weeds



88095





Product name: Titan Halosulfuron 750 WG Herbicide

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

Applicant name: Titan Ag Pty Ltd


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



89388



Product name: Eradicate Eco Snail And Slug Bait

Active constituent/s: 10 g/kg iron powder

Applicant name: Wattleglen Projects Pty Ltd


Summary of use: For the control of slugs, snails and woodlice in the home garden



86914



Product name: Obama Insecticide

Active constituent/s: 18 g/L abamectin

Applicant name: Sharda Cropchem Espana S.L

Applicant ACN: N/A

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



89694



Product name: Clip Insecticide

Active constituent/s: 500 g/L chlorpyrifos (an anti-cholinesterase compound)

Applicant name: Sharda Cropchem Espana S.L

Applicant ACN: N/A

Summary of use: For control of a wide range of insect pests on fruit, vegetables, oilseeds, cotton, cereals, pasture, turf and other situations



89696





Product name: TRS Multi Insect Killer

Active constituent/s: 1.1 g/kg esbiothrin, 0.5 g/kg permethrin



Summary of use: For control of most flying and crawling insects



89632



Product name: Coles Personal Insect Repellent Odourless

Active constituent/s: 95 g/kg picaridin



Summary of use: For use to repel mosquitoes, flies, sand flies and other annoying and biting insects for up to 4 hours



89710



Product name: Genfarm Imaze 700 Herbicide

Active constituent/s: 700 g/kg imazamox

Applicant name: Nutrien Ag Solutions Limited


Summary of use: For the post-emergence control of certain annual grass and broadleaf weeds in field peas, legume-based pastures, lucerne, peanuts and soybeans



89352



Product name: JSAL Mesosulfuron-methyl 30 + Mefenpyr-diethyl 90 OD Herbicide

Active constituent/s: 90 g/L mefenpyr-diethyl, 30 g/L mesosulfuron-methyl

Applicant name: Jiangsu Agrochem Laboratory Co Ltd

Applicant ACN: N/A

Summary of use: For the post-emergent control of wild oats and annual phalaris, and suppression of brome grass, barley grass and annual ryegrass in wheat



88314





Product name: Gharda Fipronil 200 SC Insecticide

Active constituent/s: 200 g/L fipronil

Applicant name: Gharda Australia Pty Ltd


Summary of use: For the control of insect pests in bananas, brassicas, cotton, forestry, ginger, wine grapevines, pasture, potatoes, sorghum, sugarcane, and swede



88200



Product name: Eureka! Prosulfocarb 800 EC Herbicide

Active constituent/s: 800 g/L prosulfocarb

Applicant name: Eureka! Agresearch Pty Ltd


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



86588



Product name: Roundup 360 Concentrate Weedkiller

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

Applicant name: Evergreen Garden Care Australia Pty Ltd


Summary of use: For the control of various weeds in home-garden and commercial situations



87668



Product name: Fosetyl 800 WP Fungicide

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

Applicant name: Turf Culture Pty Ltd


Summary of use: For the prevention and control of phytophthora rots in ornamentals and pythium in turf



88283



Product name: Agriclean Alkali Dairy Detergent

Active constituent/s: 390 g/L sodium hydroxide

Applicant name: Sopura Australia Pty Ltd


Summary of use: For use as a low-foaming alkali dairy detergent



88621





Product name: Relyon Clodinafop 240EC Selective Herbicide

Active constituent/s: 240 g/L clodinafop-propargyl, 60 g/L cloquintocet-mexyl

Applicant name: Ruralco Holdings Limited


Summary of use: For the control of wild oats, paradoxa grass (annual phalaris), canary grass and annual ryegrass in wheat



89434


4. VARIATIONS OF REGISTRATION


Product name: Fludora Co-Max Insecticide

Active constituent/s: 52.5 g/L transfluthrin, 26.3 g/L flupyradifurone

Applicant name: Bayer CropScience Pty Ltd



To vary the distinguishing product name and the name that appears on the label from ‘Fludora Co-Max Insecticide Space Spray Concentrate’ to ‘Fludora Co-Max Insecticide’



87732



Product name: Cambistat Plant Growth Regulator

Active constituent/s: 250 g/L paclobutrazol

Applicant name: Arbor Scientific Pty Ltd



To include additional tree species



83951



Product name: Surefire Slayer Organic Herbicide

Active constituent/s: 525 g/L nonanoic acid

Applicant name: PCT Holdings Pty Ltd



To vary the distinguishing product name and the name that appears on the label from ‘Surefire Erazer Organic Herbicide’ to ‘Surefire Slayer Organic Herbicide’



89368





Product name: Relyon Azoxystrobin 250 SC Fungicide

Active constituent/s: 250 g/L azoxystrobin

Applicant name: Nutrien Ag Solutions Limited



To vary the distinguishing product name and the name that appears on the label from ‘Galoxy 250SC Fungicide’ to ‘Relyon Azoxystrobin 250 SC Fungicide’



83086



Product name: Monarch 100 Insecticide

Active constituent/s: 100 g/L fipronil

Applicant name: Turf Culture Pty Ltd



To add various pests and update restraints



84556



Product name: Vantal Upgrade Miticide/Insecticide


Applicant name: FMC Australasia Pty Ltd



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



67524



Product name: Flute 50 EW Fungicide

Active constituent/s: 50 g/L cyflufenamid

Applicant name: Agnova Technologies Pty Ltd



To vary directions for use on grapevines and to add use on strawberry runners and plug plants



66970





Product name: Kenso Agcare Lance 200 SG Plant Growth Regulator

Active constituent/s: 200 g/kg gibberellic acid

Applicant name: Kenso Corporation (M) Sdn. Bhd.

Applicant ACN: N/A


To add use in pasture



86286



Product name: Conquest Stallion 480 SC Fungicide

Active constituent/s: 480 g/L prothioconazole

Applicant name: Conquest Crop Protection Pty Ltd



Extension of use in barley, oats, pyrethrum, triticale and wheat as a tank mix with Conquest Stingray 430 Fungicide



87362



Product name: Titan Chlorothalonil 900WG Fungicide

Active constituent/s: 900 g/kg chlorothalonil

Applicant name: Titan Ag Pty Ltd



Variation of label approval to extend the use to include the control various diseases on chickpeas, lentils, lawn, and turf



85398



Product name: Vertimec Pro Insecticide / Miticide


Applicant name: Syngenta Australia Pty Ltd



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



69685





Product name: Rainbow Abamectin Insecticide / Miticide


Applicant name: Shandong Rainbow International Co Ltd

Applicant ACN: N/A


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

Date of variation: 3 July 2020


65750




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: Independents Own Bounce Vitamin B12 Plus Selenium For Sheep And Cattle

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

Applicant name: Vetpharm Pty Ltd


Summary of use: For the registration of an injectable solution for use in sheep and cattle for the treatment and control of vitamin B12 and selenium deficiency



89176



Product name: Bimectin Paste Oral Broad Spectrum For Horses

Active constituent/s: 18.7 g/kg ivermectin

Applicant name: Bimeda (Australia) Pty Ltd


Summary of use: For treatment and control of roundworms (including arterial larval stages of Strongylus vulgaris and benzimidazole resistant small strongyles), bots, and skin lesions caused by Habronema and Draschia spp. (summer sores) and Onchocerca spp. microfilariae (cutaneous onchocerciasis)



80615



Product name: Toltrox 50 mg/mL Suspension

Active constituent/s: Toltrazuril 50 mg/mL

Applicant name: Chanelle Pharmaceuticals Manufacturing Ltd

Applicant ACN: N/A

Summary of use: For the control and prevention of coccidiosis caused by Isospora suis in piglets and coccidiosis caused by Eimeria bovis or Eimeria zuernii in cattle (calves up to 9 months of age)



88320




2. VARIATIONS OF REGISTRATION


Product name: Enduramec With Tape Horse Paste

Active constituent/s: 140.3 mg/g praziquantel, 18.7 mg/g ivermectin

Applicant name: The Hunter River Company Pty Ltd



To vary the distinguishing product name and the name that appears on the label from ‘Enduramec And Tape Horse Paste’ to ‘Enduramec With Tape Horse Paste’



86692



Product name: Previcox 57mg Hi-Select Cox-2 Flavoured Tablets: Pain & Inflammation Control

Active constituent/s: 57 mg firocoxib

Applicant name: Boehringer Ingelheim Animal Health Australia Pty Ltd



To vary the product name and to include an additional species—horses



58093


3. VARIATION OF LABEL APPROVAL


Product name: Larvadex 1% Feed Premix

Active constituent/s: 10 g/kg cyromazine

Applicant name: Elanco Australasia Pty Ltd



To update label to align with vet labelling code



52307



Product name: Cardisure Flavoured 5mg Tablets For Dogs

Active constituent/s: 5 mg/tablet pimobendan

Applicant name: Eurovet Animal Health BV

Applicant ACN: N/A


To extend uses in large breed of dogs with preclinical dilated cardiomyopathy (DCM)



81942





Product name: Cardisure Flavoured 2.5mgTablets For Dogs

Active constituent/s: 2.5 mg/tablet pimobendan


Applicant ACN: N/A


To extend uses in large breed of dogs with preclinical DCM



81946



Product name: Cardisure Flavoured 1.25mg Tablets For Dogs

Active constituent/s: 1.25 mg/tablet pimobendan


Applicant ACN: N/A





81948



Product name: Cardisure Flavoured 10mg Tablets For Dogs

Active constituent/s: 10 mg/tablet pimobendan


Applicant ACN: N/A





81944




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:

Toltrazuril

Applicant name: South Yarra Pharma Pty Ltd


Summary of use: For use in veterinary chemical products

Date of approval: 23 June 2020

Approval no.: 88414



Simazine

Applicant name: Zhejiang Zhongshan Chemical Industry Group Co Ltd

Applicant ACN: N/A

Summary of use: For use in agricultural chemical products


Approval no.: 88937



Ammonium chloride

Applicant name: RWR Veterinary Products Pty Ltd


Summary of use: For use in veterinary chemical products


Approval no.: 89034



Hydroxypropyl methylcellulose

Applicant name: Ensystex Australasia Pty Ltd



Date of approval: 2 July 2020

Approval no.: 87720



Imidacloprid

Applicant name: Shanghai E-Tong Chemical Co Ltd

Applicant ACN: N/A


Date of approval: 6 July 2020

Approval no.: 89069



2. VARIATIONS OF ACTIVE CONSTITUENT



Praziquantel

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd



Variation of relevant particulars or conditions of an approved active constituent


Approval no.: 85864



Oxytetracycline dihydrate

Applicant name: Troy Laboratories Pty Ltd



Variation of relevant particulars or conditions of an approved active constituent


Approval no.: 85630



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. 5) 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 OfficerAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001

Phone: +61 2 6770 2401Email: [email protected].


mailto:[email protected]

https://www.legislation.gov.au/Series/F2019L01105



In the previous notice on page 18 of APVMA Gazette No. 14, 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. 5) 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 (7 July 2020)Note: Subsection 82(2) of the Food Standards Australia New Zealand Act 1991 provides that variations to standards are legislative instruments, but are not subject to disallowance or sunsetting.

To commence: on gazettal of variation

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

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

Agvet chemical: buprofezin

Permitted residue: buprofezinCotton seed oil, crude T0.3

Agvet chemical: cyazofamid

Permitted residue: cyazofamid

Broccoli 2

Agvet chemical: glyphosate

Permitted residue: sum of glyphosate, N-acetyl-glyphosate and aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosateCereal grains [except barley; maize; sorghum; wheat]

T*0.1

Agvet chemical: methomyl

Permitted residue: methomylCeleriac 0.1

Agvet chemical: spinosad

Permitted residue: sum of spinosyn A and spinosyn DBurnet, salad 5Coriander (leaves, roots, stems) 5Kaffir lime leaves 5Lemon grass 5

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

Agvet chemical: ametoctradin

Permitted residue—commodities of plant origin: ametoctradinPermitted residue—commodities of animal origin: sum of ametoctradin and 6-(7-amino-5-ethyl [1,2,4] triazolo [1,5-a]pyrimidin-6-yl) hexanoic acidBasil T20




Permitted residue: buprofezin

Cereal grains *0.01Oilseed [except cotton seed] *0.01Pulses *0.01

Agvet chemical: cyazofamid

Permitted residue: cyazofamidBrassica (cole or cabbage) vegetables, head cabbages, flowerhead brassicas

2

Brassica leafy vegetables 15Parsley T10

Agvet chemical: glyphosate

Permitted residue: sum of glyphosate, N-acetyl-glyphosate and aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosateCereal grains [except barley; maize; popcorn; sorghum; wheat]

T*0.1

Popcorn T2

Agvet chemical: propyzamide

Permitted residue: propyzamide

Safflower seed T0.02

Agvet chemical: proquinazid

Permitted residue—commodities of plant origin: proquinazidPermitted residue—commodities of animal origin: sum of proquinazid and 3-(6-iodo-4-oxo-3-propyl-3H-quinazolin-2-yloxy)propionic acid, expressed as proquinazid

All other foods except animal food commodities

0.1

Pome fruits 0.3

Agvet chemical: spinosad

Permitted residue: sum of spinosyn A and spinosyn D

Herbs 5Rhubarb 2

Agvet chemical: uniconazole-p

Permitted residue: sum of uniconazole-p and its Z-isomer expressed as uniconazole-pWalnuts T*0.01



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

Agvet chemical: amisulbrom

Permitted residue: amisulbromPotato 0.3

Agvet chemical: azoxystrobin

Permitted residue: azoxystrobin

Basil T50


Permitted residue: buprofezinAll other foods except animal food commodities

0.1

Cotton seed 0.3

Agvet chemical: chlorantraniliprole

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

Safflower seed T0.1



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) 11 AUGUST 2020

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

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


MRL Contact Officer Australian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001

Phone: +61 2 6770 2401Email: [email protected]




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

The APVMA has previously gazetted particular amendments which it had made to the APVMA MRL Standard and which have been proposed as variations to maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in Schedule 20—Maximum Residue Limits of the Australia New Zealand Food Standards Code. This notice pertains to proposals (No. 3) gazetted on 7 April 2020 (No. APVMA 7).

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 5, 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.

Based on dietary exposure assessments and current health standards, the APVMA and Food Standards Australia and New Zealand (FSANZ) are satisfied that these MRLs are not harmful to public health. MRLs contained in Schedule 20 provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this means, Schedule 20 permits the sale of treated foods and protects public health by minimising residues in foods consistent with the effective control of pests and diseases.

The agreement between the Australian Government and the New Zealand Government concerning a Joint Food Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.

FSANZ made Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO) in relation to these variations and no comment was received in response to that notice.

A copy of these variations have been given to FSANZ.

The variations take effect as from the date of this notice.

This notice is published in accordance with subsection 82(7) of the Food Standards Australia New Zealand Act 1991.


MRL Contact Officer Australian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001

Phone: +61 2 6770 2401Email: [email protected]



http://www.legislation.gov.au/


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

Instrument No. APVMA 5, 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 Seventh day of July 2020



Part 1 Preliminary1 Name of instrument

This instrument is the Australia New Zealand Food Standards Code—Schedule 20maximum residue limits Variation Instrument No. APVMA 5, 2020.

2 CommencementIn accordance with subsection 82(8) of the Food Standards Australia New Zealand Act 1991, this instrument commences on the day it is published in the Gazette.

Note: A copy of the variations made by the Amendment Instrument was published in the Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette.

3 ObjectThe object of this instrument is for the APVMA to make variations to Schedule 20Maximum residue limits in the Australia New Zealand Food Standards Code to include or change maximum residue limits pertaining to agricultural and veterinary chemical products.

4 InterpretationIn this instrument: —

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

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

Part 2 Variations to Schedule 20—Maximum Residue Limits

5 Variations to Schedule 20The Schedule to this instrument sets out the variations made to the Principal Instrument by this instrument.



Schedule

Variations to Schedule 20—Maximum residue limits

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

[1.1] inserting in alphabetical order

Agvet chemical: tetraniliprole

Permitted residue: tetraniliprole

Almonds 0.05Apricots, dried 3Banana *0.01Cherries 1Edible offal (mammalian) 0.02Eggs *0.01Macadamia nuts *0.01Milks *0.01Pome fruits 0.5Poultry, edible offal of *0.01Poultry meat *0.01Prunes 3Stone fruits (except cherries) 0.7

Agvet chemical: trifludimoxazin

Permitted residue: trifludimoxazinBarley *0.01Edible offal (mammalian) *0.01Eggs *0.01Meat (mammalian) *0.01Milks *0.001Poultry, edible offal of *0.01Poultry meat *0.01Wheat *0.01

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


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

Almonds 0.1Pistachio nut T0.05Root and tuber vegetables T0.05Walnuts T0.05



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


Permitted residue—plant commodities and animal commodities other than milk: chlorantraniliprolePermitted residue—milk: sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliprolePotato *0.01Root and tuber vegetables (except potato)

T0.5

Tree nuts 0.1

Agvet chemical: methomyl

Permitted residue: methomyl

Brassica leafy vegetables T0.7Fennel, bulb T0.2Fennel, leaf T3Leek T0.5Onion, bulb T0.1Spinach T0.7

Agvet chemical: spinetoram

Permitted residue: sum of Ethyl-spinosyn-J and Ethyl-spinosyn-LMaize cereals T*0.01Olives for oil production T0.07Onion, bulb T*0.01Sorghum grains and millet T*0.01Table olives T0.07

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

Agvet chemical: fluopyram

Permitted residue—commodities of plant origin: fluopyramPermitted residue—commodities of animal origin: sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyramAssorted tropical and sub-tropical fruits—inedible peel (except banana; pineapple)

2



Agvet chemical: trifloxystrobin

Permitted residue: sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)-ethylideneaminooxymethyl] phenyl] acetic acid), expressed as trifloxystrobin equivalents

Assorted tropical and sub-tropical fruits—inedible peel (except banana; pineapple)

2



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 on the date nominated by the holder.

Approval or registration number

Name Type of approval or registration

Holder Date of cancellation

46641/123931 TimTech CuAz Wood Preservative

Label approval Arch Wood Protection (Aust) Pty Ltd

19 May 2020

55597/59872

55597/1002

Accensi Dicamba 500 Selective Herbicide

Label approvals Accensi Pty Ltd 6 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 ReviewAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001

Phone: +61 2 6770 2400

Email: [email protected]



Documents

APVMA Gazette No. 14, 14 July 2020 · Web viewEurovet Animal Health BV Applicant ACN: N/A Summary of variation: To extend uses in large breed of dogs with preclinical dilated cardiomyopathy