No. APVMA 4, Tuesday, 26 February 2019Published 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 GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
Commonwealth of Australia 2023
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any
process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and
inquiries concerning reproduction and rights should be addressed to:
Director, Communications and Parliamentary
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 activity 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
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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.
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
CONTENTS
Agricultural Chemical Products and Approved Labels.............................................................................................................Veterinary Chemical Products and Approved Labels..............................................................................................................Approved Active Constituents................................................................................................................................................Licensing of Veterinary Chemical Manufacturers..................................................................................................................Amendments to the APVMA MRL Standard..........................................................................................................................Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code........................................................Variations to Schedule 20 of the Australia New Zealand Food Standards Code..................................................................
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
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.: 118352
Product name: F.S.A. Gly 360 Herbicide
Active constituent/s: 360 g/L glyphosate present as the isopropylamine salt
Applicant name: Four Seasons Agribusiness Pty Ltd
Applicant ACN: 115 133 189
Summary of use: For the control of a broad range of annual, perennial, and aquatic weeds
Date of registration: 7 February 2019
Product registration no.:
87438
Label approval no.: 87438/11832
Application no.: 117449
Product name: Four Seasons Agribusiness Glyphosate 450 Herbicide
Active constituent/s: 450 g/L glyphosate present as the isopropylamine salt
Applicant name: Four Seasons Agribusiness Pty Ltd
Applicant ACN: 115 133 189
Summary of use: For non-selective control of many annual and perennial weeds
Date of registration: 7 February 2019
Product registration no.:
87054
Label approval no.: 87054/117449
Application no.: 116249
Product name: Titan Fluquinconazole 167 SC Seed Treatment
Active constituent/s: 167 g/L fluquinconazole
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of use: For the control of a range of foliar and head diseases in wheat and barley, plus the suppression of take-all and Septoria tritici blotch in wheat and blackleg in canola
Date of registration: 7 February 2019
Product registration no.:
86641
Label approval no.: 86641/116249
Application no.: 114310
Product name: Bosco Fungicide
Active constituent/s: 500 g/kg boscalid
Applicant name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of use: For control of dollar spot in turf
Date of registration: 8 February 2019
Product registration no.:
85970
Label approval no.: 85970/114310
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 118396
Product name: F.S.A. Trifluralin 480 Herbicide
Active constituent/s: 480 g/L trifluralin
Applicant name: Four Seasons Agribusiness Pty Ltd
Applicant ACN: 115 133 189
Summary of use: For use as a pre-emergence herbicide for the control of annual grasses and certain broadleaf weeds in certain horticultural and agricultural crops
Date of registration: 12 February 2019
Product registration no.:
87455
Label approval no.: 87455/118396
Application no.: 118442
Product name: Yates Home Pest Ant and Cockroach Killer Ready to Use Bait
Active constituent/s: 0.1 g/kg fipronil
Applicant name: Ensystex Australasia Pty Ltd
Applicant ACN: 102 221 965
Summary of use: For the control of household ants and cockroaches in various indoor and outdoor situations
Date of registration: 13 February 2019
Product registration no.:
87483
Label approval no.: 87483/118442
Application no.: 116060
Product name: Monarch G Insecticide
Active constituent/s: 0.5 g/kg fipronil
Applicant name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of use: For the control of argentine stem weevil, ants and mole crickets in home lawns, gardens, recreational, domestic and commercial turf
Date of registration: 13 February 2019
Product registration no.:
86567
Label approval no.: 86567/116060
Application no.: 118232
Product name: Sanonda Insecticide Abamectin 18 EC
Active constituent/s: 18 g/L abamectin
Applicant name: Sanonda (Australia) Pty Ltd
Applicant ACN: 059 813 973
Summary of use: For the control of pest mites and native budworm on cotton, and pest mites on pears, apples, capsicums, tomatoes, strawberries and ornamentals
Date of registration: 13 February 2019
Product registration no.:
87379
Label approval no.: 87379/118232
Application no.: 118234
Product name: Sanonda Fungicide Captan 900WG
Active constituent/s: 900 g/kg captan
Applicant name: Sanonda (Australia) Pty Ltd
Applicant ACN: 059 813 973
Summary of use For the control of certain diseases in a range of fruit crops, turf and ornamentals
Date of registration: 14 February 2019
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
Product registration no.:
87381
Label approval no.: 87381/118234
2. VARIATIONS OF REGISTRATION
Application no.: 118865
Product name: Kelpie Pro-Carb Duo TF Herbicide
Active constituent/s: 250 g/L trifluralin, 670 g/L prosulfocarb
Applicant name: Sinochem International Australia Pty Ltd
Applicant ACN: 160 164 616
Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘MISSION BOLTA DUO EC HERBICIDE’ to ‘KELPIE PRO-CARB DUO TF HERBICIDE’
Date of variation: 16 January 2019
Product registration no.:
87165
Label approval no.: 87165/118865
Application no.: 118951
Product name: Steri-Max Biocide
Active constituent/s: 120 g/L didecyl dimethyl ammonium chloride
Applicant name: Sipcam Pacific Australia Pty Ltd
Applicant ACN: 073 176 888
Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘AGRICROP STERI-MAX BIOCIDE’ to ‘STERI-MAX BIOCIDE’
Date of variation: 25 January 2019
Product registration no.:
59462
Label approval no.: 59462/118951
Application no.: 119017
Product name: Gro-Slow Plant Growth Regulator
Active constituent/s: 250 g/L paclobutrazol
Applicant name: Sipcam Pacific Australia Pty Ltd
Applicant ACN: 073 176 888
Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘AGRICROP GRO-SLOW PLANT GROWTH REGULATOR’ to ‘GRO-SLOW PLANT GROWTH REGULATOR’
Date of variation: 1 February 2019
Product registration no.:
63348
Label approval no.: 63348/119017
Application no.: 119018
Product name: Prolan 500 Herbicide
Active constituent/s: 500 g/L oryzalin
Applicant name: Sipcam Pacific Australia Pty Ltd
Applicant ACN: 073 176 888
Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘AGRICROP PROLAN 500 HERBICIDE’ to ‘PROLAN 500 HERBICIDE’
Date of variation: 1 February 2019
Product registration no.:
60335
Label approval no.: 60335/119018
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 115978
Product name: Opera Fungicide
Active constituent/s: 85 g/L pyraclostrobin, 62.5 g/L epoxiconazole
Applicant name: BASF Australia Ltd
Applicant ACN: 008 437 867
Summary of variation: To add a new 5 L and 110 L pack size
Date of variation: 7 February 2019
Product registration no.: 62753
Label approval no.: 62753/115978
Application no.: 118042
Product name: Sabakem Imidacloprid 600FS Seed Treatment Insecticide
Active constituent/s: 600 g/L imidacloprid
Applicant name: Sabakem Pty Ltd
Applicant ACN: 151 682 138
Summary of variation: To extend the use of the product to include the protection against insect pests of stored grains during storage for cereal crops, include an additional application rate for use in cotton to control thrips, aphids and brown flea beetle and extend the withholding period for grazing lupins from 9 weeks to 16 weeks
Date of variation: 6 February 2019
Product registration no.: 68994
Label approval no.: 68994/118042
Application no.: 118372
Product name: Kenso Agcare Bucko 75-D Herbicide
Active constituent/s: 300 g/L 2,4-D present as the triisopropanolamine salt, 75 g/L picloram present as the triisopropanolamine salt
Applicant name: Kenso Corporation (M) Sdn Bhd
Applicant ACN: N/A
Summary of variation: To incorporate spray drift instructions from APVMA reconsideration
Date of variation: 7 February 2019
Product registration no.: 67109
Label approval no.: 67109/118372
Application no.: 118328
Product name: Ezycrop 2,4-D Amine 625 Herbicide
Active constituent/s: 625 g/L 2,4-D present as the dimethylamine and diethanolamine salts
Applicant name: Ezycrop Pty Ltd
Applicant ACN: 156 476 827
Summary of variation: To incorporate spray drift instructions from APVMA reconsideration
Date of variation: 7 February 2019
Product registration no.: 68558
Label approval no.: 68558/118328
Application no.: 118337
Product name: Terrain 500 WG Herbicide
Active constituent/s: 500 g/kg flumioxazin
Applicant name: Sumitomo Chemical Australia Pty Limited
Applicant ACN: 081 096 255
Summary of variation: To expand the use pattern to include non-crop boundary areas
Date of variation: 11 February 2019
Product registration no.: 69830
Label approval no.: 69830/118337
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 118136
Product name: Lazco Binkill Protector
Active constituent/s: 186 g/kg dichlorvos (an anticholinesterase compound)
Applicant name: Lazco Investments Pty Ltd
Applicant ACN: 069 972 354
Summary of variation: To add uses to control cockroaches, moths, silverfish, ants, flies and other insects in storage areas and store rooms
Date of variation: 12 February 2019
Product registration no.:
67600
Label approval no.: 67600/118136
Application no.: 118440
Product name: Titan Glufosinate 200 Herbicide
Active constituent/s: 200 g/L glufosinate-ammonium
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of variation: To add uses in summer fallows, forestry plantations and the use of knapsacks and handguns in commercial and industrial areas
Date of variation: 13 February 2019
Product registration no.:
66364
Label approval no.: 66364/118440
Application no.: 118157
Product name: Kojak 75D Herbicide
Active constituent/s: 300 g/L 2,4-D as the triisopropanolamine salt, 75 g/L picloram as the triisopropanolamine salt
Applicant name: Crop Culture Pty Ltd
Applicant ACN: 142 860 473
Summary of variation: To incorporate spray drift instructions from the APVMA’s reconsideration
Date of variation: 14 February 2019
Product registration no.:
85354
Label approval no.: 85354/118157
Application no.: 118333
Product name: Big Red Spray Marker Dye
Active constituent/s: 150 g/L rhodamine B
Applicant name: Sipcam Pacific Australia Pty Ltd
Applicant ACN: 073 176 888
Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘AGRICROP BIG RED SPRAY MARKER DYE’ to ‘BIG RED SPRAY MARKER DYE’
Date of variation: 14 February 2019
Product registration no.:
56461
Label approval no.: 56461/118333
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 118327
Product name: Vendex Miticide
Active constituent/s: 550 g/L fenbutatin oxide
Applicant name: UPL Australia Limited
Applicant ACN: 066 391 384
Summary of variation: To remove state restrictions in the Directions for Use and to increase the pack size range
Date of variation: 14 February 2019
Product registration no.:
68860
Label approval no.: 68860/118327
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
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
Application no.: 113495
Product name: Omoshield Oral Paste for Horses
Active constituent/s: 92.5 mg/g omeprazole
Applicant name: Ceva Animal Health Pty Ltd
Applicant ACN: 002 692 426
Summary of use: For the prevention and treatment of gastric ulcers in horses
Date of registration: 7 February 2019
Product registration no.:
85518
Label approval no.: 85518/113495
Application no.: 118395
Product name: Randlab Ketamine Injection
Active constituent/s: 100 mg/mL ketamine as hydrochloride
Applicant name: Randlab Australia Pty Ltd
Applicant ACN: 114 948 837
Summary of use: For use as a dissociative anaesthetic for use singly or in combination with muscle relaxants and tranquilisers in horses, camels, dogs, cats, cattle, sheep, goats, deer, kangaroos, koalas, wombats, pigs, birds and reptiles
Date of registration: 12 February 2019
Product registration no.:
87454
Label approval no.: 87454/118395
Application no.: 117314
Product name: AbbeyFlor Oral For Pigs
Active constituent/s: 23 g/L florfenicol
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of use: For the treatment of pig respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma spp. and Streptococcus suis type 2.
Date of registration: 13 February 2019
Product registration no.:
87009
Label approval no.: 87009/117314
Application no.: 118473
Product name: AbbeyFlor Injection For Cattle And Pigs
Active constituent/s: 300 mg/mL florfenicol
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of use: For the treatment of bacterial infections in cattle and pigs susceptible to florfenicol
Date of registration: 14 February 2019
Product registration no.:
87488
Label approval no.: 87488/118473
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 116349
Product name: TeatPlug
Active constituent/s: 650 mg/g bismuth subnitrate
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of use: For the prevention of mastitis in dairy cows during the non-lactating (dry) period and early post-calving
Date of registration: 14 February 2019
Product registration no.:
86681
Label approval no.: 86681/116349
2. VARIATIONS OF REGISTRATION
Application no.: 116029
Product name: ACP 2 Anaesthetic Premedication Tranquilliser & Travel Sickness Injection
Active constituent/s: acepromazine maleate 2.9 mg/ml equivalent to acepromazine 2 mg/ml
Applicant name: Ceva Animal Health Pty Ltd
Applicant ACN: 002 692 426
Summary of variation:
To add in-use shelf life
Date of variation: 21 January 2019
Product registration no.:
36680
Label approval no.: 36680/116029
Application no.: 118983
Product name: Enro 50 Antibiotic Tablets
Active constituent/s: 50 mg enrofloxacin
Applicant name: Dechra Veterinary Products (Australia) Pty Ltd
Applicant ACN: 614 716 700
Summary of variation:
To change the distinguishing product name and the name that appears on the label from ‘APEX ENROFLOXACIN 50 ANTIBIOTIC TABLETS’ to ‘ENRO 50 ANTIBIOTIC TABLETS’
Date of variation: 31 January 2019
Product registration no.:
59484
Label approval no.: 59484/118983
Application no.: 119019
Product name: Di-Fly SPRAY-ON BLOWFLY TREATMENT FOR SHEEP
Active constituent/s: 50 g/L dicyclanil
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of variation:
To change the distinguishing product name and the name that appears on the label from ‘FLYGUARD SPRAY-ON SHEEP BLOWFLY TREATMENT’ to ‘Di-Fly SPRAY-ON BLOWFLY TREATMENT FOR SHEEP’
Date of variation: 5 February 2019
Product registration no.:
86844
Label approval no.: 86844/119019
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 115971
Product name: Sedator Injection
Active constituent/s: 10 mg/mL detomidine hydrochloride
Applicant name: Randlab Australia Pty Ltd
Applicant ACN: 114 948 837
Summary of variation:
To add an additional pack size
Date of variation: 07 February 2019
Product registration no.:
82623
Label approval no.: 82623/115971
Application no.: 118929
Product name: Starmec Pour-On For Beef and Dairy Cattle
Active constituent/s: 5 g/L ivermectin
Applicant name: The Hunter River Company Pty Limited
Applicant ACN: 133 798 615
Summary of variation:
Approval of a new label for the product 'STARMEC POUR-ON FOR BEEF AND DAIRY CATTLE' with the label name 'INDEPENDENTS OWN MECTEC POUR-ON FOR BEEF AND DAIRY CATTLE'
Date of variation: 11 February 2019
Product registration no.:
70317
Label approval no.: 70317/118929
Application no.: 117417
Product name: Flusapex Drops Diuretic For Dogs & Cats
Active constituent/s: 10 mg/ml frusemide
Applicant name: Dechra Veterinary Products (Australia) Pty Ltd
Applicant ACN: 614 716 700
Summary of variation:
To update the label’s contraindication, precaution and side effect statements
Date of variation: 13 February 2019
Product registration no.:
35636
Label approval no.: 35636/117417
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
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.
3. ACTIVE CONSTITUENT
Application no.: 116859
Active constituent/s:
cloquintocet-mexyl
Applicant name: BASF Australia Ltd
Applicant ACN: 008 437 867
Summary of use: For use in agricultural chemical products
Date of approval: 8 February 2019
Approval no.: 86869
Application no.: 116018
Active constituent/s:
imazapic
Applicant name: BASF Australia Ltd
Applicant ACN: 008 437 867
Summary of use: For use in agricultural chemical products
Date of approval: 14 February 2019
Approval no.: 86545
Application no.: 116579
Active constituent/s:
pyraclostrobin
Applicant name: Agroshine Australia Pty Ltd
Applicant ACN: 105 873 023
Summary of use: For use in agricultural chemical products
Date of approval: 14 February 2019
Approval no.: 86792
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
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:
VERITA PHARMA PTY LTD Licence number: 2250
ACN: 604 520 532
Unit 3, 4 Endeavour Road
TAREN POINT NSW 2229
Product types:*
Category 2: Pastes, powders and suspensions
Category 4: Premixes – Powder, Supplements - Powder
Steps of manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, storage and release for supply
Licence issued: 11 December 2018
2. CHANGES TO EXISTING LICENCES
The APVMA has issued the following licences under subsection 123(1) of the Agvet Code:
LUINA BIO PTY LTD LICENCE NO: 1086
ACN: 074 656 509
2806 Ipswich Road
DARRA QLD 4076
Product Types: *
Category 1: Vaccine (Low bioburden processing)
Step(s) of Manufacture: Quality assurance (QA) of raw materials, cell propagation, virus cultivation, bacterial fermentation, low bioburden filling, packaging, labelling, microbiological reduction treatment (heat, filtration, chemical), freeze drying, analysis and testing (physical, chemical), release for supply, storage
Amended Licence Issued: 18 December 2018
*Category 1: Immunobiologicals and sterile veterinary preparationsCategory 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplementsCategory 3: EctoparasiticidesCategory 4: Premixes and supplementsCategory 5: ExemptCategory 6: One-step manufacturer
Licensing of Veterinary Chemical Manufacturers
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
PARAFARM PTY LTD LICENCE NO: 2246
ACN: 161 661 696
Factory 2, 3 Bray Street
HASTINGS VIC 3915
Product Types:*
Category 2: Powders, liquids
Category 3: Powders
Category 4: Premixes, supplements
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, dry milling, packaging, labelling, analysis and testing (physical), storage and release for supply.
Licence Issued: 18 December 2018
3. LICENCE CANCELLATIONS
The APVMA has cancelled the following licences under subsection 127(1) of the Agvet Code:
MCKINNON DIRECT PACKAGING & FULFILMENT PTY LTD
Licence number: 6207
ACN: 068 259 496
Unit A 2 Hudson Avenue
CASTLE HILL NSW 2154
Date cancelled: 18 December 2018
NEW HORIZONS ENTERPRISES LIMITED
Licence number: 6076
ACN: 002 066 604
15 Twin Road
NORTH RYDE NSW 2113
Date cancelled: 02 January 2019
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
*Category 1: Immunobiologicals and sterile veterinary preparationsCategory 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplementsCategory 3: EctoparasiticidesCategory 4: Premixes and supplementsCategory 5: ExemptCategory 6: One-step manufacturer
Licensing of Veterinary Chemical Manufacturers
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994
6. REVOCATION OF LICENCE SUSPENSION
The APVMA has revoked the suspension of the following licences under subsection 127(7) of the Agvet Code:
KATO LABORATORIES PTY LTD
LICENCE NO: 2119
ACN: 000 397 240
61 Chivers Road
SOMERSBY NSW 2250
Date Suspension revoked: 18 January 2019
APVMA CONTACT
Manufacturing Quality and Licensing
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4899
Email: [email protected]
*Category 1: Immunobiologicals and sterile veterinary preparationsCategory 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplementsCategory 3: EctoparasiticidesCategory 4: Premixes and supplementsCategory 5: ExemptCategory 6: One-step manufacturer
Licensing of Veterinary Chemical Manufacturers
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994 17
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 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 Australian Pesticides and Veterinary Medicines AuthorityPO Box 6182KINGSTON ACT 2604
Phone: +61 2 6210 4897Fax: +61 2 6210 4840Email: [email protected]
Amendments to the APVMA MRL Standard
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994 18
Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code
In the previous notice on page 16 of APVMA Gazette No. 4, 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.
Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994 19
PROPOSED VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE 21 February 2019Note: 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: Cyprodinil
Permitted residue: CyprodinilBulb vegetables [except Fennel, Bulb; Garlic; Onion, Bulb]
T3
Agvet chemical: Fludioxonil
Permitted residue: Fludioxonil
Bulb vegetables [except fennel, bulb; garlic; onion, bulb]
T3
Agvet chemical: Phosphorous acid
Permitted residue: Phosphorous acid
Assorted tropical and sub-tropical fruits – inedible peel [except avocado]
T100
Agvet chemical: Haloxyfop
Permitted residue: Sum of haloxyfop, its esters and conjugates, expressed as haloxyfopGarlic T0.05Guar bean (dry) T2Sugar cane T0.03
[1.2] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order
Agvet chemical: Acetamiprid
Permitted residue—commodities of plant origin: AcetamipridPermitted residue—commodities of animal origin: Sum of acetamiprid and N-demethyl acetamiprid ((E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyanoacetamidine), expressed as acetamiprid
Avocado 0.05Macadamia nuts *0.01Mango 0.05
Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994 20
Agvet chemical: Cyprodinil
Permitted residue: Cyprodinil
Bulb vegetables [except fennel, bulb; onion, bulb]
T3
Agvet chemical: Fludioxonil
Permitted residue: Fludioxonil
Bulb vegetables [except fennel, bulb; onion, bulb]
T3
Agvet chemical: Haloxyfop
Permitted residue: Sum of haloxyfop, its esters and conjugates, expressed as haloxyfopSesame seed T0.1
Agvet chemical: Metolachlor
Permitted residue: Metolachlor
Sesame seed T*0.02
Agvet chemical: PenthiopyradPermitted residue—commodities of plant origin: PenthiopyradPermitted residue—commodities of animal origin: Sum of penthiopyrad and 1-methyl-3-(trifluoromethyl)-1H-pyrazol-4-ylcarboxamide, expressed as penthiopyradBayberries T5Bayberry, red T5
Agvet chemical: Phosphorous acid
Permitted residue: Phosphorous acid
Assorted tropical and sub-tropical fruits – inedible peel [except avocado; passionfruit]
T100
Passionfruit T500
Agvet chemical: Pirimicarb
Permitted residue: Sum of pirimicarb, demethyl-pirimicarb and the N-formyl-(methylamino) analogue (demethylformamido-pirimicarb), expressed as pirimicarbSesame seed T0.05
Agvet chemical: Pyripoxyfen
Permitted residue: Pyripoxyfen
Avocado 0.05
Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994 21
Macadamia nuts *0.01
[1.3] omitting for each of the following chemicals, the maximum residue limit for the food and substituting
Agvet chemical: Cyfluthrin
Permitted residue: Cyfluthrin, sum of isomersChia T*0.05
Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019 Agricultural and Veterinary Chemicals Code Act 1994 22
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) 26 March 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 AuthorityPO Box 6182KINGSTON ACT 2604
Phone: +61 2 6210 4897Fax: +61 2 6210 4840Email: [email protected]
Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019. Agricultural and Veterinary Chemicals Code Act 1994 23
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. 11) gazetted on 4 December 2018 (No. APVMA 24).
Submissions have been sought on these proposals and the APVMA has written separately to each person or organisation that made a submission. All matters raised in the submissions have been resolved.
Under subsection 82(1) of the Food Standards Australia New Zealand Act 1991, the APVMA has, by legislative instrument, incorporated these variations to MRLs into Schedule 20. A copy of the Amendment Instrument (No. APVMA 2, 2019) accompanies this notice. For a complete and up-to-date version of Schedule 20, including these amendments together with their Explanatory Statement, please refer to the Federal Register of Legislation available on the Legislation website at www.legislation.gov.au
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 comment was received in response to that notice that resulted in the decision to not progress the imidacloprid MRL reduction for carrot at this time.
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.
For further information please contact:
MRL Contact Officer Australian Pesticides and Veterinary Medicines AuthorityPO Box 6182KINGSTON ACT 2604
Phone: +61 2 6210 4897Fax: +61 2 6210 4840Email: [email protected]
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Australia New Zealand Food Standards Code—Schedule 20—Maximum residue
limits Variation Instrument No. APVMA 2, 2019
I, Jason Lutze, Executive Director, Risk Assessment Capability and 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 twenty first day of February 2019
Variations to Schedule 20 of the Australia New Zealand Food Standards Code
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019. Agricultural and Veterinary Chemicals Code Act 1994
Part 1 Preliminary1 Name of instrument
This instrument is the Australia New Zealand Food Standards Code—Schedule 20maximum residue limits Variation Instrument No. APVMA 2, 2019.
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.
Variations to Schedule 20 of the Australia New Zealand Food Standards Code 25
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019. Agricultural and Veterinary Chemicals Code Act 1994
Schedule
Variations to Schedule 20–Maximum residue limits
[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: Azoxystrobin
Permitted residue: Azoxystrobin
Adzuki bean (dry) T0.7Broad bean (dry) (fava bean) T0.05Chick-pea (dry) T0.5Common bean (dry) (navy bean) T0.7Field Pea (dry) T0.05Lentil (dry) T0.5Lupin (dry) T0.05Mung bean (dry) T0.7
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 bixafenPulses *0.01
Agvet chemical: Fluensulfone
Permitted residue: Sum of fluensulfone, 3,4,4-trifluorobut-3-ene-1-sulfonic acid (M-3627) and 5-chloro-thiazole-2-sulfonic acid (M-3625)Sweet potato T1
Agvet chemical: Imidacloprid
Permitted residue: Sum of imidacloprid and metabolites containing the 6-chloropyridinylmethylene moiety, expressed as imidacloprid
Assorted tropical and sub-tropical fruits – inedible peel [except banana]
T1
Bergamot T5Burnet, salad T5Coriander, seed T5Dill, seed T5Fennel, bulb T0.1Fennel, seed T5Ginger, Japanese T5
Variations to Schedule 20 of the Australia New Zealand Food Standards Code 26
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019. Agricultural and Veterinary Chemicals Code Act 1994
Agvet chemical: Phosphorous acid
Permitted residue: Phosphorous acid
Root and tuber vegetables T100
[1.2] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order
Agvet chemical: Amisulbrom
Permitted residue: Amisulbrom
All other foods except animal commodities
0.02
Potato T0.3
Agvet chemical: Azoxystrobin
Permitted residue: AzoxystrobinPulses 0.3
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
Pulses [except lupin (dry)] *0.01Lupin (dry) T0.1
Agvet chemical: Cyprodinil
Permitted residue: Cyprodinil
Bayberries T3Bayberry, red T3
Agvet chemical: Diafenthiuron
Permitted residue: Sum of diafenthiuron; N-[2,6-bis(1-methylethyl)- 4-phenoxyphenyl]-N'-(1,1-dimethylethyl)urea; and N-[2,6-bis(1-methylethyl)-4-phenoxyphenyl]- N'-(1,1-dimethylethyl)carbodiimide, expressed as diafenthiuron
All other foods except animal commodities
0.01
Rape seed (canola) *0.01
Variations to Schedule 20 of the Australia New Zealand Food Standards Code 27
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019. Agricultural and Veterinary Chemicals Code Act 1994
Agvet chemical: Dinotefuran
Permitted residue—commodities of plant origin: DinotefuranPermitted residue—commodities of animal origin: Sum of Dinotefuran and 1-methyl-3-(tetrahydro-3-furylmethyl) urea (UF) expressed as dinotefuran
All other foods except animal commodities
0.02
Mung bean (dry) 0.3
Agvet chemical: Ethephon
Permitted residue: EthephonAll other foods except animal commodities
0.1
Blueberries T10
Agvet chemical: Fludioxonil
Permitted residue—commodities of animal origin: sum of fludioxonil and oxidizable metabolites, expressed as fludioxonil Permitted residue—commodities of plant origin: fludioxonil
Bayberries T2Bayberry, red T2
Agvet chemical: Indoxacarb
Permitted residue: Sum of Indoxacarb and it’s R-isomerBayberry, red T1
Agvet chemical: Phosphine
Permitted residue: All phosphides, expressed as hydrogen phosphide (phosphine)Garlic T*0.01
Agvet chemical: Phosphorous acid
Permitted residue: Phosphorous acid
Root and tuber vegetables (except potato)
T100
Potato T700
Agvet chemical: Praziquantel
Permitted residue: PraziquantelTuna T*0.01
Variations to Schedule 20 of the Australia New Zealand Food Standards Code 28
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019. Agricultural and Veterinary Chemicals Code Act 1994
Agvet chemical: Spinetoram
Permitted residue: Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-LBayberry, red T0.5Fig T0.1
Agvet chemical: Tebuconazole
Permitted residue: TebuconazoleSweet corn (corn-on-the-cob) T0.7
[1.3] omitting for each of the following chemicals, the maximum residue limit for the food and substituting
Agvet chemical: Azoxystrobin
Permitted residue: Azoxystrobin
Rape seed (canola) 0.01
Agvet chemical: Bifenthrin
Permitted residue: BifenthrinCherries T3
Agvet chemical: Clothianidin
Permitted residue: ClothianidinAlmonds T0.05Citrus fruits 0.5
Agvet chemical: Fluopyram
Permitted residue—commodities of plant origin: FluopyramPermitted residue—commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyramEdible offal (mammalian) 0.3Pome fruits 1
Agvet chemical: Sulfoxaflor
Permitted residue: SulfoxaflorCherimoya T0.5Custard apple T0.5Ilama T0.5Soursop T0.5Sugar apple T0.5
Variations to Schedule 20 of the Australia New Zealand Food Standards Code 29
Commonwealth of Australia GazetteNo. APVMA 4, Tuesday, 26 February 2019. Agricultural and Veterinary Chemicals Code Act 1994
Agvet chemical: Tebuconazole
Permitted residue: Tebuconazole
Pulses [except soya bean (dry)] 1
Variations to Schedule 20 of the Australia New Zealand Food Standards Code 30