apvma gazette no. 11, 5 june 2018 · for the control of subterranean termites and ants around...

No. APVMA 11, Tuesday, 5 June 2018

Published by The Australian Pesticides and Veterinary Medicines Authority

AGRICULTURAL AND

VETERINARY CHEMICALS

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 Gazette No. APVMA 11, Tuesday, 5 June 2018 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2018

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:

Director, Public Affairs and Communications

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

Kingston ACT 2604

Email: [email protected]

Website: www.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 activ ity in

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

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

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

If you would like to receive email notification when a new edition is published, please subscribe on the APVMA website.

APVMA CONTACTS

For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4812

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

mailto:[email protected]

http://www.apvma.gov.au/

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


CONTENTS

Agricultural Chemical Products and Approved Labels................................................................................................. 4 Veterinary Chemical Products and Approved Labels ................................................................................................ 16 Licensing of Veterinary Chemical Manufacturers ...................................................................................................... 20 Affirmation of Product Registration and Associated Labels Notice Under s 34AC(1)(b) of the Agvet Code .................. 22 Amendments to the APVMA MRL Standard ............................................................................................................. 25 Proposal to Amend Schedule 20 in the Australia New Zealand Food Standards Code............................................... 26


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.: 107182

Product name: Alpha-Scud 300 SC Insecticide

Active constituent/s: 300 g/L alpha-cypermethrin

Applicant name: Adama Australia Pty Limited

Applicant ACN: 050 328 973

Summary of use: For the control of various pests including red legged earth mite and blue oat mite

in field crops and pastures, fruit and vegetable crops

Date of registration: 14 May 2018

Product registration no.: 82944

Label approval no.: 82944/107182


Product name: Terminade Max Residual Termiticide and Insecticide

Active constituent/s: 200 g/L fipronil

Applicant name: PCT Holdings Pty Ltd


Summary of use: For pre and post-construction protection from subterranean termite damage and for the control of subterranean termites and ants around domestic and commercial

structures





Product name: Bobcat i-MAXX SG Herbicide

Active constituent/s: 150 g/kg imazapic, 750 g/kg hexazinone



Summary of use: For the control of grasses and broadleaf weeds in sugar cane





Product name: Sorcerer 36 Insecticide

Active constituent/s: 36 g/L abamectin



Summary of use: For the control of a range of mite and insect pests in apples, blackcurrants, capsicums, citrus, hops, ornamentals, pears, tomatoes, soybeans, strawberries

and vegetables







Product name: Genfarm Terbuthylazine 875 WG Herbicide

Active constituent/s: 875 g/kg terbuthylazine

Applicant name: Landmark Operations Limited


Summary of use: For the control of weeds in cereals (barley, oats, wheat), chickpeas, faba beans,

fallows, field peas, lentils, lupins, sorghum and triazine tolerant canola





Product name: Campbell Fludy 230SC Fungicide

Active constituent/s: 230 g/L fludioxonil

Applicant name: Colin Campbell (Chemicals) Pty Ltd


Summary of use: For the control of postharvest diseases of certain fruit





Product name: GP Regain 600 Herbicide

Active constituent/s: 600 g/kg tebuthiuron

Applicant name: Granular Products Assets Pty Ltd


Summary of use: For control of brigalow and tea tree regrowth, Mimosa pigra and woody weeds on

grazing lands





Product name: Agrevo Clethodim 240EC Herbicide

Active constituent/s: 240 g/L clethodim

Applicant name: Agrevo Australia Pty Ltd


Summary of use: For the control of certain grass weeds in beetroot, cabbage, canola, celery,

chickpeas, cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans







Product name: Kesai Atrazine 900 WG Herbicide

Active constituent/s: 900 g/kg atrazine

Applicant name: Shandong Kesai Eagrow Co Ltd

Applicant ACN: N/A

Summary of use: For the control of annual grasses and broadleaf weeds in sorghum, maize, sugar

cane, TT-canola and lucerne, and for fallow area maintenance and other situations as per the directions for use table





Product name: Ozcrop Imazapic 700 WG Herbicide

Active constituent/s: 700 g/kg imazapic

Applicant name: Ozcrop Pty Ltd


Summary of use: For the pre-emergence control of certain annual grass and broadleaf weeds in fallow situations and sugar cane





Product name: Eurochem Knocker 240 EC Herbicide

Active constituent/s: 240 g/L carfentrazone-ethyl

Applicant name: Ronic International Pty Limited


Summary of use: For improvement in the control of marshmallow and certain other broadleaf weeds

prior to establishment of broad acre crops, fallows or forest plantations, in commercial, industrial and public service areas, and around agricultural buildings and yards, in tree fruits, nuts, grapevines, in tank mixture with knockdown

herbicides, for the control of marshmallow and annual nettles in grass pastures and rough grass/turf areas, and control of volunteer cotton seedlings including roundup ready cotton and desiccation of cotton re-growth





Product name: Farmalinx Zilch Miticide

Active constituent/s: 100 g/L hexythiazox

Applicant name: Farmalinx Pty Ltd


Summary of use: For the control of two-spotted mite (Tetranychus urticae) and European red mite

(Panonychus ulmi) on apples, pears, stone fruit and ornamentals, and for the control of two-spotted mite on strawberries







Product name: Sabakem Metaldehyde Snail and Slug Pellets

Active constituent/s: 15 g/kg metaldehyde

Applicant name: Sabakem Pty Ltd


Summary of use: For the control of slugs and snails in agricultural and horticultural crops,

vineyards, and other agricultural, industrial and commercial situations





Product name: Greenzone Perimeter Barrier

Active constituent/s: 2 g/kg deltamethrin (Equivalent to 1 g/m2 deltamethrin)

Applicant name: Green Zone Pty Ltd


Summary of use: For control of subterranean termites in commercial, industrial, domestic and public

buildings under construction





Product name: Splat lbam HD-O Mating Disruption Agent

Active constituent/s: 95 g/kg E-11-tetradecen-1-yl acetate, 5 g/kg E-9-E-11-Tetradecadien-1yl acetate

Applicant name: Organic Crop Protectants Pty Ltd


Summary of use: For control of light brown apple moth in orchards, vineyards and other crops or situations





Product name: Smart Nostra Seed Dressing

Active constituent/s: 25 g/L tebuconazole, 4g/L triflumuron

Applicant name: Crop Smart Pty Ltd


Summary of use: For the control of bunt, flag smut and loose smut of wheat and covered and loose

smut of barley and oats, and protection against insect pests of stored grain in storage







Product name: EmuAg Trifluralin 480EC Herbicide

Active constituent/s: 480 g/L trifluralin

Applicant name: EmuAg Pty Ltd


Summary of use: For use as a pre-emergent herbicide for the control of annual grasses and

broadleaf weeds in horticultural and agricultural crops





Product name: Raingran Herbicide

Active constituent/s: 400 g/L bentazone (present as the sodium salt), 60 g/L MCPA (present as the

potassium salt)

Applicant name: Shandong Rainbow International Co Ltd

Applicant ACN: N/A

Summary of use: For the post-emergence control of certain broadleaf weeds in rice





Product name: Kenso Agcare Captan 900 WG Fungicide

Active constituent/s: 900 g/kg captan

Applicant name: Kenso Corporation (M) SDN BHD

Applicant ACN: N/A

Summary of use: For the control of certain diseases in a range of fruit crops, turf and ornamentals





Product name: Sinon Gowel 240 Herbicide

Active constituent/s: 240 g/L oxyfluorfen

Applicant name: Sinon Australia Pty Limited


Summary of use: For the selective control of broadleaf weeds and some grasses as specified in the

directions for use table





Product name: Puraway Ultracide Tropical Strength Algaecide

Active constituent/s: 19 g/L copper (Cu) present as a complex blend of copper salts, 100 g/L

benzalkonium chloride

Applicant name: Bundalo Pty Ltd


Summary of use: For use in tropical pools for the control of blue-green, black and mustard algae







Product name: Agmate Prosulfocarb 800 Herbicide

Active constituent/s: 800 g/L prosulfocarb

Applicant name: Agcare Pty Ltd


Summary of use: For the control of annual ryegrass (Lolium rigidum) in barley and wheat





Product name: Dais Gold Medal Pool Products MultiPurpose Plus Algaecide

Active constituent/s: 400 g/L benzalkonium chloride

Applicant name: Chemistry House Pty Ltd


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





Product name: EmuAg Simazine 900WG Herbicide

Active constituent/s: 900 g/kg simazine



Summary of use: For control of weeds in almonds, asparagus, berry fruit, chickpeas, citrus, faba

beans, gladioli, hops, lupins, pome fruit, roses, vineyards, TT-canola and other crops





Product name: Chippolay Selective Herbicide

Active constituent/s: 700 g/kg methabenzthiazuron

Applicant name: Agnova Technologies Pty Ltd


Summary of use: For the control of annual broadleaf weed seedlings in onions





Product name: Dais Gold Medal Pool Products Ducks Away

Active constituent/s: 100 g/L benzalkonium chloride, 23.5 g/L alcohol ethoxylate

Applicant name: Chemistry House Pty Ltd


Summary of use: To deter ducks from swimming pools







Product name: EmuAg Metribuzin 750WG Herbicide

Active constituent/s: 750 g/kg metribuzin



Summary of use: For selective weed control in potatoes, peas, soybeans, faba beans, tomatoes,

barley and white lupins




2. VARIATIONS OF REGISTRATION


Product name: Mortein Powergard The Expert's Cockroach Baits

Active constituent/s: 2.5 g/kg indoxacarb

Applicant name: Reckitt Benckiser (Australia) Pty Limited


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘MORTEIN POWERGARD COCKROACH BAITS ’ to ‘MORTEIN

POWERGARD THE EXPERT'S COCKROACH BAITS ’

Date of variation: 16 April 2018




Product name: Mortein Powergard The Expert's DIY Indoor & Outdoor Surface Spray

Active constituent/s: 0.6 g/L deltamethrin



Summary of variation: To change the distinguishing product name and the name that appears on the

label from ‘MORTEIN POWERGARD DIY PROFESSIONAL OUTDOOR & INDOOR SURFACE SPRAY’ to ‘MORTEIN POWERGARD THE EXPERT'S DIY

INDOOR & OUTDOOR SURFACE SPRAY’





Product name: Mortein Powergard The Expert's Flea & Crawling Insect Control Bomb

Active constituent/s: 1.07 g/kg fenoxycarb, 10 g/kg permethrin




label from ‘MORTEIN POWERGARD FLEA & CRAWLING INSECT CONTROL BOMB’ to ‘MORTEIN POWERGARD THE EXPERT'S FLEA & CRAWLING

INSECT CONTROL BOMB’







Product name: Mortein Powergard The Expert’s Flying Insect Killer

Active constituent/s: 0.9 g/kg D-allethrin 20:80, 0.9 g/kg D-phenothrin 20:80, 3.15 g/kg tetramethrin

20:80




label from ‘MORTEIN POWERGARD FLYING INSECT KILLER ’ to ‘MORTEIN POWERGARD THE EXPERT’S FLYING INSECT KILLER’





Product name: Mortein Powergard The Expert’s Flying Insect Killer Odourless

Active constituent/s: 0.9 g/kg D-allethrin, 0.9 g/kg D-phenothrin, 3.15 g/kg tetramethrin




label from ‘MORTEIN POWERGARD FLYING INSECT KILLER ODOURLESS ’ to ‘MORTEIN POWERGARD THE EXPERT’S FLYING INSECT KILLER ODOURLESS’





Product name: Mortein Powergard The Expert’s Cockroach Gel

Active constituent/s: 2.5 g/kg indoxacarb




label from ‘MORTEIN POWERGARD COCKROACH GEL’ to ‘MORTEIN POWERGARD THE EXPERT’S COCKROACH GEL’





Product name: Grochem Ziram WG Fungicide

Active constituent/s: 760 g/kg ziram

Applicant name: Grochem Australia Pty Ltd



label from ‘MELPAT ZIRAM WG FUNGICIDE’ to ‘GROCHEM ZIRAM WG FUNGICIDE’







Product name: Grochem Dusting Sulphur Fungicide/Miticide

Active constituent/s: 930 g/kg sulphur (S) present as powdered sulphur




label from ‘MELPAT DUSTING SULPHUR FUNGICIDE - MITICIDE’ to ‘GROCHEM DUSTING SULPHUR FUNGICIDE/MITICIDE ’





Product name: Coppox WP Fungicide/Bactericide

Active constituent/s: 500 g/kg copper (Cu) present as copper oxychloride



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘MELPAT COPPOX WP AGRICULTURAL FUNGICIDE/BACTERICIDE ’

to ‘COPPOX WP FUNGICIDE/BACTERICIDE’





Product name: Nufarm Bromicide 200 Selective Herbicide

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

Applicant name: Nufarm Australia Limited


Summary of variation: To update pasture and certain other sections of the label and add pack size range

of 1L–1000L

Date of variation: 14 May 2018


Label approval no.: 31614/ 113089


Product name: Titan Atlas 500 WG Aphicide

Active constituent/s: 500 g/kg pirimicarb (an anti-cholinesterase compound)

Applicant name: Titan Ag Pty Ltd


Summary of variation: To remove use in knapsacks and add a restraint stating ‘do not apply by

equipment carried on the back of the user’. Safety directions and first aid statements have also been updated



Label approval no.: 61797/ 115153




Product name: Karate Zeon Insecticide

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

Applicant name: Syngenta Australia Pty Ltd


Summary of variation: To extend use to include control of Russian wheat aphid in wheat and barley and

to remove state restriction where it occurs in barley, wheat, canola, legumes, cotton, lucerne and pasture





Product name: Microsul WG Elite Fungicide/Miticide

Active constituent/s: 800 g/kg sulphur (S) as sulphur



Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘MICROSUL WG ELITE WETTABLE GRANULAR SULPHUR

FUNGICIDE/MITICIDE’ to ‘MICROSUL WG ELITE FUNGICIDE/MITICIDE’





Product name: Thermo Flush Liquid Acid Dairy Detergent

Active constituent/s: 750 g/L phosphoric acid, 100 g/L glycolic acid, 12.5 g/l dodicin

Applicant name: Tasman Chemicals Pty Limited


Summary of variation: To approve a new label for the registered product 'THERMO FLUSH LIQUID ACID

DAIRY DETERGENT' with the label name 'KONFLICT LIQUID ACID DAIRY DETERGENT'





Product name: Roundup Ready Herbicide With Plantshield By Monsanto

Active constituent/s: 690 g/kg glyphosate present as the mono-ammonium salt

Applicant name: Monsanto Australia Ltd


Summary of variation: To remove NSW and QLD states restriction at a particular growth stage of

roundup ready flex cotton







Product name: Mesh For Mosquito And Moth Control

Active constituent/s: 100 g/kg metofluthrin

Applicant name: Sumitomo Chemical Australia Pty Limited


Summary of variation: To extend use to include control of clothing moth in household situations and t o

change the distinguishing product name and the name that appears on the label from ‘MOZZIEMESH MOSQUITO CONTROL’ to ‘MESH FOR MOSQUITO AND MOTH CONTROL’





Product name: Roundup Ready PL Herbicide

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

Applicant name: Monsanto Australia Ltd


Summary of variation: To remove NSW and QLD states restriction at a particular growth stage of

roundup ready flex cotton





Product name: Stamina Systemic Fungicide

Active constituent/s: 400 g/kg myclobutanil

Applicant name: Agrinova New Zealand Limited

Applicant ACN: N/A

Summary of variation: To extend use to include control of powdery mildew on grape vines





Product name: Rainbow Pirimicarb 500 WG Aphicide


Applicant name: Shandong Rainbow International Co Ltd

Applicant ACN: N/A

Summary of variation: To remove knapsack or backpack use and to update the safety directions





Product name: Conquest Pirimidex WG Aphicide


Applicant name: Conquest Crop Protection Pty Ltd


Summary of variation: To remove knapsack or backpack use and to update the safety directions







Product name: Cheminova Pirimicarb WG Aphicide


Applicant name: FMC Australasia Pty Ltd


Summary of variation: To amend the safety directions, remove knapsack use from the directions for use,

and to add a restraint to not apply by equipment carried on the back of the user





Product name: Mortein Powergard The Expert's Crawling Insect Surface Spray

Active constituent/s: 0.7 g/kg imiprothrin, 2 g/kg cypermethrin



Summary of variation: To vary claims to include long reach spray up to 2m and to change the distinguishing

product name and the name that appears on the label from ‘MORTEIN POWERGARD CRAWLING INSECT SURFACE SPRAY’ to ‘MORTEIN POWERGARD THE EXPERT'S

CRAWLING INSECT SURFACE SPRAY’





Product name: Nufarm Tally 800WG Aphicide


Applicant name: Nufarm Australia Limited


Summary of variation: To update restraints and safety directions





Product name: Imtrade Pirimicarb 500 WG Aphicide


Applicant name: Imtrade Australia Pty Ltd


Summary of variation: To update the label to amend the safety directions, remove knapsack use from the directions for use, and to add a restraint to not apply by equipment carried on the back

of the user





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: Aba Low Volume Abamectin Broad Spectrum Antiparasitic For Sheep And Lambs

Active constituent/s: 2 g/L abamectin

Applicant name: Abbey Laboratories Pty Ltd


Summary of use: For the treatment and control of abamectin sensitive strains of internal parasites

(including benzimidazole, levamisole and morantel resistant strains), itch mite and nasal bot of sheep





Product name: Zolvix Monepantel Broad Spectrum Oral Anthelmintic for Cattle

Active constituent/s: 25 mg/mL monepantel

Applicant name: Elanco Animal Health a Div Of Eli Lilly Aust Pty Ltd


Summary of use: For the treatment and control of amino-acetonitrile derivative (add)-sensitive

gastrointestinal nematodes in beef and non-lactating dairy cattle





Product name: Enduramec Horse Paste

Active constituent/s: 18.7 g/kg ivermectin

Applicant name: Pullulo Pharm 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)







Product name: Abamec LV Plus Selenium Broad Spectrum Antiparasitic For Sheep And Lambs

Active constituent/s: 2.0 g/L abamectin,1.0 g/L selenium (as sodium selenate)

Applicant name: Abbey Laboratories Pty Ltd


Summary of use: For the treatment and control of abamectin sensitive strains of gastrointestinal

roundworms and lungworms in sheep, including benzimidazole and levamisole resistant strains. For the treatment and control of nasal bot and for the treatment and prevention of selenium deficiencies in sheep




2. VARIATIONS OF REGISTRATION


Product name: Independents Own Metaject CBG Calcium Borogluconate Injection

Active constituent/s: 29.7 g/L calcium as calcium borogluconate

Applicant name: The Hunter River Company Pty Limited


Summary of variation: To change the distinguishing product name and the name that appears on the label

from ‘BOUNCE CBG CALCIUM BOROGLUCONATE INJECTION ’ to ‘INDEPENDENTS OWN METAJECT CBG CALCIUM BOROGLUCONATE

INJECTION’





Product name: Fido's Pyrethrin Shampoo For Cats And Dogs

Active constituent/s: 1 g/L pyrethrins, 10 g/L piperonyl butoxide

Applicant name: Mavlab Pty Ltd


Summary of variation: To approve a new label for the registered product 'FIDO'S PYRETHRIN SHAMPOO

FOR CATS AND DOGS' with the label name 'WELL AND GOOD FLEA SHAMPOO FOR DOGS AND CATS'





Product name: Bravecto 1400 mg Fluralaner Chewable Tablets For Very Large Dogs

Active constituent/s: 136.4 g/kg fluralaner

Applicant name: Intervet Australia Pty Limited


Summary of variation: To extend the claim to treatment and control of bush ticks (Haemaphysalis

longicornis), to update the flea allergy dermatitis claim, and to update compatibility and side effect statement







Product name: Bravecto 112.5 mg Fluralaner Chewable Tablets For Very Small Dogs












Product name: Bravecto 500 mg Fluralaner Chewable Tablets For Medium Dogs










Product name: Bravecto 1000 mg Fluralaner Chewable Tablets For Large Dogs




Summary of variation: To extend the claim to treatment and control of bush ticks (Haemaphysalis longicornis), to update the flea allergy dermatitis claim, and to update compatibility and

side effect statement





Product name: Bravecto 250 mg Fluralaner Chewable Tablets For Small Dogs










Product name: Elanco AF0602 Paylean 20 Ractopamine Hydrochloride Premix

Active constituent/s: 20 g/kg ractopamine hydrochloride

Applicant name: Elanco Australasia Pty Ltd


Summary of variation: To extend the use to breeding sows





* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides

Category 4: Premixes and supplements Category 5: Exempt Category 6: Single-step manufacturer

Licensing of Veterinary Chemical Manufacturers


Pursuant to Part 8 of the Agricultural and Veterinary Chemicals Code (Agvet Code), scheduled to the Agricultural and

Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has taken action with respect to the

licensing of the following veterinary chemical manufacturers with effect from the dates shown.

For a comprehensive listing of all licensed manufacturers please see the APVMA’s website www.apvma.gov.au.

1. NEW LICENCES

The APVMA has issued the following licences under subsection 123(1) of the Agvet Code:

VETLAB STERILE PTY LTD Licence number: 1112

ACN: 616 832 010

41 Harris Street

NORTH ST MARYS NSW 2760

Product types:*

Category 1: Sterile products

Steps of manufacture: Quality assurance (QA) of raw materials, formulation

including blending, filling, aseptic filling, sterilisation (heat and filtration),

microbiological reduction treatment (heat and filtration), packaging, labelling,

analysis and testing (physical), storage and release for supply.

Licence issued: 18 April 2018

2. CHANGES TO EXISTING LICENCES

The APVMA has issued the following licences under subsection 123(1) of the Agvet Code:

Nil

3. LICENCE CANCELLATIONS

The APVMA has cancelled the following licences under subsection 127(1) of the Agvet Code:

Nil

4. LICENCE SUSPENSIONS

The APVMA has suspended the following licences under subsection 127(1) of the Agvet Code:

Nil

5. REVOCATION OF LICENCE CANCELLATION

The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agvet Code:

Nil

http://www.apvma.gov.au/


* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides

Category 4: Premixes and supplements Category 5: Exempt Category 6: Single-step manufacturer


6. REVOCATION OF LICENCE SUSPENSION

The APVMA has revoked the suspension of the following licences under subsection 127(7) of the Agvet Code:

Nil

APVMA CONTACT

Manufacturing Quality and Licensing


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4899




Affirmation of Product Registration and Associated Labels Notice Under s 34AC(1)(b) of the Agvet Code


On 17 May 2018, the APVMA:

1. Under s 34(1) of the Agvet Code, affirmed the registrations of polihexanide products listed in Table 1;

2. Affirmed the approval of labels for containers of the Polihexanide products listed in Table 1 column 5;

3. Under s 81(3) of the Agvet Code, determined that a one year period from the date of this decision shall

apply for the continued supply of registered products bearing earlier approved labels listed in column 4 of

Table 1.

Table 1: Polihexanide products and label approvals

APVMA

product

registration

number

(1)

Product name

(2)

Registration holder

(3)

Previously

approved

labels, now

varied as an

outcome of

the review

(4)

New label

approval

number

(5)

48356 HTL Bio-Blu Swimming Pool and

Spa Water Treatment and

Sanitiser

HTL Pty Ltd 48356/107402 48356/RV05

18A

49284 King Neptune’s Ozone Clear Pool

Sanitiser

Isaac Technologies Pty

Ltd

49284/1098 49284/

RV0518B

57606 Aquafresh by Lo-Chlor Pool

Sanitiser

M I International Pty Ltd

T/A Lo-Chlor

Chemicals

57606/56365 57606/

RV0518C

59949 Aquaspa By Lo-Chlor Spa

Sanitiser

M I International Pty Ltd

T/A Lo-Chlor

Chemicals

59949/0509 59949/

RV0518D

61106

Clark Rubber Filtrite Sanit-Eezy

for Family Pools Eezy Sanitiser

Clark Rubber

Franchising pty Ltd

61106/59508

61106/

RV0518E

64278 Nature Spa Spa Water Treatment

& Sanitiser

Enviro Spa & Pool Pty

Ltd

64278/0909 64278/

RV0518F

64823 Clark Rubber Filtrite Sanit-Eezy

Eezy Sanitiser

Clark Rubber

Franchising pty Ltd

64823/50208 64823/

RV0518G

66624 Crystal Waters Spa Sanitiser M I International Pty Ltd

T/A Lo-Chlor

Chemicals

66624/56198 66624/

RV0518H

66943 Crystal Waters Pool Sanitiser M I International Pty Ltd

T/A Lo-Chlor

Chemicals

66943/57122 66943/

RV0518I



APVMA

product

registration

number

(1)

Product name

(2)

Registration holder

(3)

Previously

approved

labels, now

varied as an

outcome of

the review

(4)

New label

approval

number

(5)

68964 Filtrite Sanit-Eezy Eezy Sanitiser

for Spas Spa Sanitiser

Clark Rubber

Franchising pty Ltd

68964/59507 68964/

RV0518J

82162 Spa Soft Spa Sanitiser M I International Pty

Ltd T/A Lo-Chlor

Chemicals

82162/105117 82162/

RV0518K

54149 F10SC Veterinary Disinfectant Health & Hygiene Pty

Ltd

54149/0502 54149/

RV0518L

59720 F10SCXD Veterinary Disinfectant

Cleanser

Health & Hygiene Pty

Ltd

59720/1105 59720/

RV0518M

59998 Trigene II Virucidal Disinfectant

Concentrate

Ceva Animal Health

Pty Ltd (formerly

Delvet Pty Ltd)

59998/0906 59998/

RV0518N

62103 Microtech 7000 General Purpose

Disinfectant

Chemetall (Australasia)

Pty Ltd

62103/0508 62103/

RV0518O

70073 Safe4 Disinfectant Cleaner

Concentrate

Safe4 All (Aust) Pty Ltd 70073/106951 70073/

RV0518P

58543 F10 Germicidal Treatment

Shampoo

Health & Hygiene Pty

Ltd

58543/0207 58543/

RV0518Q

58544 F10 Germicidal Barrier Ointment Health & Hygiene Pty

Ltd

58544/1105 58544/

RV0518R

60080 Dermcare Otoflush Dermcare-Vet Pty Ltd 60080/0407 60080/

RV0518S

BRIEF STATEMENT OF REASONS

Decision to affirm the registration of polihexanide products

The APVMA was not satisfied that the products, specified in Table 1 above, would meet the safety criteria for the purposes of s 34(1)(a) of the Agvet Code when used according to the previously approved instructions (as listed in column 4 of Table 1).

However, the APVMA was satisfied for the purposes of s 34A(1)(b) that the relevant particulars of product registrations and label approvals (namely, signal headings, first aid instructions and safety directions) were capable of being varied in such a way as to allow the APVMA to be satisfied. Having so varied those particulars of the products specified in Table 1, the registration Table 1 column 1 and label approval Table 1 column 5 were affirmed.

SUPPLY OF PRODUCTS BEARING PREVIOUSLY APPROVED LABELS

As the relevant particulars of polihexanide products have been varied, it is more likely than not that there are products which have left the custody of the manufacturer bearing labels which were the approved label (that is, the labels stated the relevant particulars that were required to be stated on the label prior to the decisions of 17 May 2018), but which are now unapproved labels.



The APVMA has determined, in accordance with s 81(3)(b) of the Agvet Code, that a one year period from the date of this decision shall apply for the continued supply and use of registered products bearing the earlier approved labels as specified in column 4 of Table 1. During this time, products may continue to be used according to the earlier approved label instructions. After that period all product that is supplied should bear the varied approved label.

APVMA CONTACT

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

Chemical Review


PO Box 6182

SYMONSTON ACT 2609

Phone: +61 2 6210 4749

Fax: +61 2 6210 4773




Amendments to the APVMA MRL Standard

Amendments to the APVMA MRL Standard

The Australian Pesticides and Veterinary Medicines Authority (APVMA) approves maximum residue limits (MRLs) of

agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. The MRLs

approved by the APVMA are associated with a regulatory decision to register a product, grant a permit approval, or as an

outcome from a review decision and are set out in the Agricultural and Veterinary Chemicals Code 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 2018 (No. 6).

The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code Instrument

No. 4 (MRL Standard) 2012.

The MRL Standard is accessible via the Federal Register of Legislation website www.legislation.gov.au or the links

above.

For further information please contact:

MRL Contact Officer


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4897

Fax: +61 2 6210 4840


http://www.comlaw.gov.au/Current/F2012L02501

http://www.comlaw.gov.au/Current/F2012L02501

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

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 25 of APVMA Gazette No. 11, the APVMA gazetted amendments which it has approved

to vary maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set

out as in the APVMA’s MRL Standard.

Under section 82 of the Food Standards Australia New Zealand Act 1991, the APVMA is proposing to incorporate those

variations (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2018

(No. 6)) 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

(5 June 2018)

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: Pendimethalin

Permitted residue: Pendimethalin

Root and tuber vegetables *0.05

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

Agvet chemical: Aminoethoxyvinylglycine

Permitted residue: Aminocyclopyrachlor

Almonds *0.05

Agvet chemical: Pendimethalin

Permitted residue: Pendimethalin

Carrot T0.3

Root and tuber vegetables [except carrot]

*0.05

Agvet chemical: Pyridate

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

Poppy seed T0.05



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) 3 July 2018

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


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4897

Fax: +61 2 6210 4840



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