APVMA Gazette No. 04, 26 February 2019 · Web viewCommonwealth of Australia Gazette No. APVMA 4, Tuesday, 26 February 2019.Agricultural and Veterinary Chemicals Code Act 199419 Commonwealth

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

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.

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


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..................................................................


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


Product name: Four Seasons Agribusiness Glyphosate 450 Herbicide

Active constituent/s: 450 g/L glyphosate present as the isopropylamine salt



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



87054



Product name: Titan Fluquinconazole 167 SC Seed Treatment

Active constituent/s: 167 g/L fluquinconazole

Applicant name: Titan Ag Pty Ltd


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



86641



Product name: Bosco Fungicide

Active constituent/s: 500 g/kg boscalid

Applicant name: Turf Culture Pty Ltd


Summary of use: For control of dollar spot in turf



85970





Product name: F.S.A. Trifluralin 480 Herbicide

Active constituent/s: 480 g/L trifluralin



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



87455



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


Summary of use: For the control of household ants and cockroaches in various indoor and outdoor situations



87483



Product name: Monarch G Insecticide

Active constituent/s: 0.5 g/kg fipronil

Applicant name: Turf Culture Pty Ltd


Summary of use: For the control of argentine stem weevil, ants and mole crickets in home lawns, gardens, recreational, domestic and commercial turf



86567



Product name: Sanonda Insecticide Abamectin 18 EC

Active constituent/s: 18 g/L abamectin

Applicant name: Sanonda (Australia) Pty Ltd


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



87379



Product name: Sanonda Fungicide Captan 900WG

Active constituent/s: 900 g/kg captan

Applicant name: Sanonda (Australia) Pty Ltd


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





87381


2. VARIATIONS OF REGISTRATION


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


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


87165



Product name: Steri-Max Biocide

Active constituent/s: 120 g/L didecyl dimethyl ammonium chloride

Applicant name: Sipcam Pacific Australia Pty Ltd


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’



59462



Product name: Gro-Slow Plant Growth Regulator

Active constituent/s: 250 g/L paclobutrazol



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


63348



Product name: Prolan 500 Herbicide

Active constituent/s: 500 g/L oryzalin



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’



60335





Product name: Opera Fungicide

Active constituent/s: 85 g/L pyraclostrobin, 62.5 g/L epoxiconazole

Applicant name: BASF Australia Ltd


Summary of variation: To add a new 5 L and 110 L pack size


Product registration no.: 62753



Product name: Sabakem Imidacloprid 600FS Seed Treatment Insecticide

Active constituent/s: 600 g/L imidacloprid

Applicant name: Sabakem Pty Ltd


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





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





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


Summary of variation: To incorporate spray drift instructions from APVMA reconsideration





Product name: Terrain 500 WG Herbicide

Active constituent/s: 500 g/kg flumioxazin

Applicant name: Sumitomo Chemical Australia Pty Limited


Summary of variation: To expand the use pattern to include non-crop boundary areas







Product name: Lazco Binkill Protector

Active constituent/s: 186 g/kg dichlorvos (an anticholinesterase compound)

Applicant name: Lazco Investments Pty Ltd


Summary of variation: To add uses to control cockroaches, moths, silverfish, ants, flies and other insects in storage areas and store rooms



67600



Product name: Titan Glufosinate 200 Herbicide

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

Applicant name: Titan Ag Pty Ltd


Summary of variation: To add uses in summer fallows, forestry plantations and the use of knapsacks and handguns in commercial and industrial areas



66364



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


Summary of variation: To incorporate spray drift instructions from the APVMA’s reconsideration



85354



Product name: Big Red Spray Marker Dye

Active constituent/s: 150 g/L rhodamine B



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’



56461





Product name: Vendex Miticide

Active constituent/s: 550 g/L fenbutatin oxide

Applicant name: UPL Australia Limited


Summary of variation: To remove state restrictions in the Directions for Use and to increase the pack size range



68860




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: Omoshield Oral Paste for Horses

Active constituent/s: 92.5 mg/g omeprazole

Applicant name: Ceva Animal Health Pty Ltd


Summary of use: For the prevention and treatment of gastric ulcers in horses



85518



Product name: Randlab Ketamine Injection

Active constituent/s: 100 mg/mL ketamine as hydrochloride

Applicant name: Randlab Australia Pty Ltd


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



87454



Product name: AbbeyFlor Oral For Pigs

Active constituent/s: 23 g/L florfenicol

Applicant name: Abbey Laboratories Pty Ltd


Summary of use: For the treatment of pig respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma spp. and Streptococcus suis type 2.



87009



Product name: AbbeyFlor Injection For Cattle And Pigs

Active constituent/s: 300 mg/mL florfenicol



Summary of use: For the treatment of bacterial infections in cattle and pigs susceptible to florfenicol



87488





Product name: TeatPlug

Active constituent/s: 650 mg/g bismuth subnitrate



Summary of use: For the prevention of mastitis in dairy cows during the non-lactating (dry) period and early post-calving



86681


2. VARIATIONS OF REGISTRATION


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


Summary of variation:

To add in-use shelf life



36680



Product name: Enro 50 Antibiotic Tablets

Active constituent/s: 50 mg enrofloxacin

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd



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’



59484



Product name: Di-Fly SPRAY-ON BLOWFLY TREATMENT FOR SHEEP

Active constituent/s: 50 g/L dicyclanil




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’



86844





Product name: Sedator Injection

Active constituent/s: 10 mg/mL detomidine hydrochloride

Applicant name: Randlab Australia Pty Ltd



To add an additional pack size



82623



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



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'



70317



Product name: Flusapex Drops Diuretic For Dogs & Cats

Active constituent/s: 10 mg/ml frusemide

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd



To update the label’s contraindication, precaution and side effect statements



35636




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


Active constituent/s:

cloquintocet-mexyl



Summary of use: For use in agricultural chemical products

Date of approval: 8 February 2019

Approval no.: 86869



imazapic





Approval no.: 86545



pyraclostrobin

Applicant name: Agroshine Australia Pty Ltd




Approval no.: 86792

Approved Active Constituents


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


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


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




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]



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

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

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

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

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


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.



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




Permitted residue: Cyprodinil

Bulb vegetables [except fennel, bulb; onion, bulb]

T3


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



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



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



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.





mailto:[email protected]

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.





mailto:[email protected]

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

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


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


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





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


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


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


0.01

Rape seed (canola) *0.01



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


0.02

Mung bean (dry) 0.3

Agvet chemical: Ethephon

Permitted residue: EthephonAll other foods except animal commodities

0.1

Blueberries T10


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



Root and tuber vegetables (except potato)

T100

Potato T700

Agvet chemical: Praziquantel

Permitted residue: PraziquantelTuna T*0.01



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


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



Agvet chemical: Tebuconazole

Permitted residue: Tebuconazole

Pulses [except soya bean (dry)] 1


Documents

APVMA Gazette No. 04, 26 February 2019 · Web viewCommonwealth of Australia Gazette No. APVMA 4, Tuesday, 26 February 2019.Agricultural and Veterinary Chemicals Code Act 199419 Commonwealth