apvma gazette no. 18, 8 september 2015 · commonwealth of australia gazette no. apvma 18, tuesday,...

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No. APVMA 18, Tuesday, 8 September 2015 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

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Page 1: APVMA Gazette No. 18, 8 September 2015 · Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 6 * Category

No. APVMA 18, Tuesday, 8 September 2015

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

Page 2: APVMA Gazette No. 18, 8 September 2015 · Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 6 * Category

Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2015

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:

The Manager, Public Affairs and Communications

The 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 grant ed 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/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 4870

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

Page 3: APVMA Gazette No. 18, 8 September 2015 · Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 6 * Category

Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 3

CONTENTS

Cancellation of Registration at the Request of the Holder ...................................................................................................... 4 Approval of New Agricultural Active Constituents under section 14A of the Agvet Code Act ................................................. 5 Licensing of Veterinary Chemical Manufacturers ................................................................................................................... 6 Amendments to the APVMA MRL Standard ........................................................................................................................... 9 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code ................................................... 10 Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code .............................................................. 15

Page 4: APVMA Gazette No. 18, 8 September 2015 · Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 6 * Category

Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 4

Cancellation of Registration at the Request of the Holder

Cancellation of Registration at the Request of the Holder

At the request of the holder, the APVMA has cancelled the registration and the associated label approvals of the following products:

Product no. Product name Approval holder Date of effect

57919 SASHAS BLEND JOINT HEALTH

CAPSULES

INTERPATH PTY LTD 31 August 2015

54231 SASHAS BLEND JOINT HEALTH POWDER INTERPATH PTY LTD 31 August 2015

68795 SMART FENAMIPHOS 400 EC

INSECTICIDE

CROP SMART PTY LTD 31 August 2015

The following instructions set out how a person can deal with the cancelled products.

SUPPLY

A person may supply or cause to be supplied products manufactured prior to 31 August 2015 at wholesale and retail

level, until the 31 August 2016.

After 31 August 2016 it will be an offence against the Agvet Codes to have possession or custody of the products with

the intention to supply, or to supply the products.

USE

A person may continue to use the products according to label instructions until 31 August 2016.

Any person who possesses, has custody of, uses, or otherwise deals with the listed products in accordance with the

above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of,

use or otherwise deal with the products after the registration has been cancelled until 31 August 2016.

The supply and use of the products must be in accordance with the conditions of registration or approval, including any

conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the products listed in the table in a manner that

contravenes the above instructions.

APVMA CONTACT

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

Chemical Review

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

SYMONSTON ACT 2609

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776

Email: [email protected]

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Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 5

Approval of New Agricultural Active Constituents under section 14A of the Agvet Code Act

Approval of New Agricultural Active Constituents under section 14A of the Agvet Code Act

Under section 14A of the Agvet Code Act, the APVMA may approve an active constituent for which information is not

readily available, however the APVMA must have regard to the safety of that active constituent. Further details are

available at www.comlaw.gov.au.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it a consideration for the approval of

six new active constituents, as listed in Table 1.

Table 1

Name: CAS Number: Other Information:

Sodium Lauryl Sulfate 151–21–3 Sulfuric acid monododecyl ester sodium salt (1:1)

Peppermint Oil 8006–90–4 Extractives and their physically modified derivatives. Mentha piperita,

Labiatae.

Cinnamon leaf Oil 8015–91–6 Extractives and their physically modified derivatives. Cinnamomum

zeylanicum, Lauraceae.

Lemongrass Oil 72869–82–0 Terpenes and Terpenoids

Thyme Oil 8007–46–3 Extractives and their physically modified derivatives. Thymus vulgaris

or Thymus zygis, Labiatae.

Geranium Oil 8000–46–2 Extractives and their physically modified derivatives. Pelargonium

graveolens or Pelargonium radula, Geraniaceae.

SUMMARY OF THE APVMA’S EVALUATION OF THE ACTIVES IN TABLE 1

The Chemistry and Manufacture Section of the APVMA has evaluated the actives in table 1 and found them to be

acceptable.

The APVMA is satisfied that the statutory requirements of Section 14A of the Agvet Code Act of 1994 regarding the

toxicological hazard and the safety of people exposed to these actives during the handling and use, have been met.

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Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 6

* 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: One-step manufacturer

Licensing of Veterinary Chemical Manufacturers

Licensing of Veterinary Chemical Manufacturers

Pursuant to Part 8 of the Agricultural and Veterinary Chemical Codes 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 Agricultural and Veterinary

Chemicals Code [the Agvet Code]

Nil

2. CHANGES TO EXISTING LICENCES

The APVMA has issued the following licences under subsection 123(1) of the Agricultural and Veterinary

Chemicals Code [the Agvet Code

PADULA SERUMS PTY. LTD. LICENCE NO: 1105

ACN: 167 348 610

26 Howitt Ave

BAIRNSDALE VIC 3875

Product Types: *

Category 1: Immunobiologicals (snake antivenom, tetanus antitoxin and

equine plasma products)

Step(s) of Manufacture: Quality assurance (QA) of raw materials, blood

collection, plasma separation*, management and immunisation of donor animals,

labelling, analysis and testing (physical, chemical, serological, immunobiological,

mouse bioassay for potency), storage and release for supply.

Amended Licence Issued: 3 August 2015

UNIVERSITY OF NEW

ENGLAND

LICENCE NO: 6142

ABN: 75 792 454 315

Reproductive & Metabolic

Endocrinology Laboratory

School of Science & Technology

McClymont Building

University of New England

ARMIDALE NSW 2351

Product Types: *

Category 6: Single Step Manufacture

Step(s) of Manufacture: Quality assurance (QA) of raw materials, analysis and

testing (physical, chemical, pharmacological and immunological)

Amended Licence Issued: 6 August 2015

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Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 7

* 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: One-step manufacturer

Licensing of Veterinary Chemical Manufacturers

CEVA ANIMAL HEALTH PTY

LTD

LICENCE NO: 1070

ACN: 002 692 426

11 Moores Road

GLENORIE NSW 2157

Product Types: *

Category 1: Sterile products

Category 2: creams, lotions, pastes, powders, granules, tablets and

liquids.

Category 4: Premixes and supplements

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation

including blending, dry milling, wet milling, granulation, tableting, filling, aseptic

filling, packaging, labelling, sterilisation (heat and filtration), microbiological

reduction treatment (heat and filtration), analysis and testing (physical and

chemical), storage and release for supply.

Amended Licence Issued: 20 August 2015

THE STATE OF QUEENSLAND

ACTING THROUGH THE

DEPARTMENT OF

AGRICULTURE AND

FISHERIES

LICENCE NO: 1018

ABN: 66 934 348 189

Tick Fever Centre

280 Grindle Road

WACOL QLD 4076

Product Types: *

Category 1: Immunobiologicals

Step(s) of Manufacture: Quality assurance (QA) of raw materials, management

and inoculation of donor animals, blood collection, formulation including blending,

aseptic filling, filling, packaging, labelling, sterilisation (heat and filtration),

microbiological reduction treatment (heat and filtration), analysis and testing

(physical, sterility, microbiological, serological and other pharmacological test),

storage and release for supply.

Amended Licence Issued: 20 August 2015

HY GAIN FEEDS PTY. LIMITED LICENCE NO: 6088

ACN: 006 198 821

10 Hickson Road

OFFICER VIC 3809

Product Types: *

Category 6: Single Step

Step(s) of Manufacture: Quality assurance (QA) of raw materials, labelling,

storage and release for supply

Amended Licence Issued: 27 August 2015

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Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 8

* 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: One-step manufacturer

Licensing of Veterinary Chemical Manufacturers

3. LICENCE CANCELLATIONS

The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary

Chemicals Code [the Agvet Code].

ARUMPO BENTONITE PTY

LIMITED

LICENCE NO: 4065

ACN: 001 831 483

Arumpo Road

BURONGA NSW 2739

Date Cancelled: 17 August 2015

4. LICENCE SUSPENSIONS

The APVMA has suspended the following licences under subsection 127(1) of the Agricultural and Veterinary

Chemicals Code [the Agvet Code].

AUSTRALIAN ANIMAL BLOOD

BANK PTY LTD

LICENCE NO: 1101

ACN: 140 128 990

50 Wills Road

LONG POINT NSW 2564

Date Suspended: 14 August 2015 (to 14 November 2015)

5. REVOCATION OF LICENCE CANCELLATION

The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agricultural and

Veterinary Chemicals Code [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 Agricultural and

Veterinary Chemicals Code [the Agvet Code].

Nil

APVMA CONTACT

Manufacturing Quality and Licensing Section

Legal and Compliance Program

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4899

Fax: +61 2 6210 4813

Email: [email protected]

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Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 9

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 2015 (No. 8).

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 ComLaw website www.comlaw.gov.au or the links above.

For further information please contact:

MRL Contact Officer

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4897

Fax: +61 2 6210 4840

Email: [email protected]

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Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 10

Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code

Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code

In the previous notice, the APVMA gazetted that amendments which it has approved varying maximum residue limits

(MRLs) for substances contained in agricultural and veterinary chemical products as set out as in the APVMA’s MRL

Standard, have been made.

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 2015

(No. 8)) to MRLs into Standard 1.4.2. Maximum Residue Limits of the Australia New Zealand Food Standards Code.

MRLs contained in Standard 1.4.2 provide the limits for residues of agricultural and veterinary chemicals that may

legitimately occur in foods. By this means, Standard 1.4.2 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 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 Government of Australia and the Government of New Zealand 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.

Food Standards Australia New Zealand (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 Standard 1.4.2 in the APVMA Gazette. The variations will

take effect as from the date of that subsequent notice.

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Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 11

Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code

DRAFT VARIATIONS TO THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE

Note: The following amendments are in a format that accords with the proposed amending Legislative Instrument

which, in turn, has to be consistent with the existing format of Standard 1.4.2 (Maximum Residue Limits) of the

Australia New Zealand Food Standards Code.

PROPOSED AMENDMENT (AGRICULTURAL AND VETERINARY CHEMICALS CODE INSTRUMENT NO. 4 (MRL

STANDARD) AMENDMENT INSTRUMENT 2015 (NO. 8))

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

Standard 1.4.2 of the Australia New Zealand Food Standards Code is varied by –

1. omitting from Schedule 1 all entries for the following chemicals–

Dinotefuran

2. inserting in Schedule 1 –

Dinotefuran Commodities of plant origin: Dinotefuran

Commodities of animal origin: Sum of Dinotefuran and 1-methyl-3-(tetrahydro-3-furylmethyl) urea (UF)

expressed as dinotefuran

Cotton seed 0.1

Cranberry 0.2

Edible offal (mammalian) *0.02

Eggs *0.02

Grapes 0.9

Meat (mammalian) *0.02

Milks *0.02

Poultry, edible offal of *0.02

Poultry meat *0.02

3. omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –

Bifenazate

Sum of bifenazate and bifenazate diazene (diazenecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl-3-yl] 1-methylethyl ester), expressed as bifenazate

Peas T0.5

Phosphorous acid

Phosphorous acid

Berries and other small fruits [except riberries]

T50

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Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 12

Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code

4. inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals –

Abamectin

Sum of avermectin B1a, avermectin B1b and (Z)-8,9 avermectin B1a, and (Z)-8,9 avermectin B1b

Pome fruits [except apple; pear] T0.01

Bifenazate

Sum of bifenazate and bifenazate diazene (diazenecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl-3-yl] 1-methylethyl ester), expressed as bifenazate

Podded pea (young pods) (snow and sugar snap)

T1

Cyflufenamid

Cyflufenamid

Strawberry T*0.01

Emamectin

Sum of emamectin B1a and emamectin B1b

Chia T0.05

Fluazifop-p-butyl

Sum of fluazifop-butyl, fluazifop and their conjugates, expressed as fluazifop

Olives T0.05

Phosphorous acid

Phosphorous acid

Berries and other small fruit [except riberries; strawberry]

T50

Strawberry T500

Pyraclostrobin Commodities of plant origin: Pyraclostrobin

Commodities of animal origin: Sum of pyraclostrobin and metabolites hydrolysed to 1-(4-chloro-phenyl)-

1H-pyrazol-3-ol, expressed as pyraclostrobin

Chick-pea (dry) T0.5

Lentil (dry) T0.5

Sethoxydim

Sum of sethoxydim and metabolites containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulfoxides and sulfones,

expressed as sethoxydim

Quinoa T0.5

Spirotetramat

Sum of spirotetramat, and cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one,

expressed as spirotetramat

Chia T1

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Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 13

Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code

5. omitting from Schedule 1, under the entries for the following chemicals, the maximum residue limit for the food, substituting –

Cypermethrin

Cypermethrin, sum of isomers

Poppy seed T*0.05

Dimethoate

Sum of dimethoate and omethoate, expressed as dimethoate

see also Omethoate

Oilseed [except peanut] 0.2

Imidacloprid

Sum of imidacloprid and metabolites containing the 6-chloropyridinylmethylene moiety, expressed as

imidacloprid

Peanut *0.05

Omethoate

Omethoate see also Dimethoate

Oilseed 0.05

Thiamethoxam Commodities of plant origin: Thiamethoxam

Commodities of animal origin: Sum of thiamethoxam and N-(2-chloro-thiazol-5-ylmethyl)-N′-methyl-N′-

nitro-guanidine, expressed as thiamethoxam

Mango 0.07

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Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 14

Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code

INVITATION FOR SUBMISSIONS

Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the

proposal to vary Standard 1.4.2 Maximum Residue Limits of 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

Standard 1.4.2’ and quote the correct amendment number.

DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (AEST) 6 October 2015

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

Submissions received after this date will only be considered if agreement for an extension has been given prior to this

closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to

the submission period.

For further information please contact:

MRL Contact Officer

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4897

Fax: +61 2 6210 4840

Email: [email protected]

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Commonwealth of Australia Gazette No. APVMA 18, Tuesday, 8 September 2015 Agricultural and Veterinary Chemicals Code Act 1994 15

Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code

Variations to Standard 1.4.2 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 Standard 1.4.2–Maximum Residue Limits of the Australia New Zealand

Food Standards Code. This notice pertains to proposals (No. 5) gazetted on 16 June 2015 (No. APVMA 12).

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 Standard 1.4.2. A copy of the Amendment Instrument

(No. APVMA 7, 2015) accompanies this notice. For a complete and up-to-date version of Standard 1.4.2, including these

amendments together with their Explanatory Statement, please refer to the Federal Register of Legislative Instrument

available on the Comlaw website at www.comlaw.gov.au.

Based on dietary exposure assessments and current health standards, the APVMA and FSANZ are satisfied that these

MRLs are not harmful to public health. MRLs contained in Standard 1.4.2 provide the limits for residues of agricultural

and veterinary chemicals that may legitimately occur in foods. By this means, Standard 1.4.2 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 Government of Australia and the Government of New Zealand 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.

Food Standards Australia New Zealand (FSANZ) made Sanitary and Phytosanitary (SPS) notification to the World Trade

Organization (WTO) in relation to these variations and no comment was received in response to that notice.

A copy of these variations have been given to FSANZ.

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

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

For further information please contact:

Residues Contact Officer

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4897

Fax: +61 2 6210 4840

Email: [email protected]

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Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code

Australia New Zealand Food Standards Code — Standard 1.4.2 — Maximum Residue Limits Amendment Instrument No. APVMA 7, 2015

I, Rajumati Bhula, Executive Director, Scientific Assessment and Chemical Review 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.

Rajumati Bhula

Delegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines

Authority

Dated this Second day of September 2015

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Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code

Part 1 Preliminary

1 Name of Instrument

This Instrument is the Australia New Zealand Food Standards Code—Standard 1.4.2—Maximum Residue Limits Amendment Instrument No. APVMA 7, 2015.

2 Commencement

Pursuant to subsection 82(8) of the Food Standards Australia New Zealand Act 1991, this Amendment Instrument commences on the day a copy of 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 No. APVMA 18 of 8 September 2015.

3 Object

The object of this Instrument is for the APVMA to make variations to Standard 1.4.2—Maximum Residue Limits of the Australia New Zealand Food Standards Code to include or change maximum residue limits pertaining to agricultural and veterinary chemical products.

4 Interpretation

In 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 Standard 1.4.2—Maximum Residue Limits of the Australia New Zealand Food Standard Code as defined in Section 4of 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. The whole of the Australia New Zealand Food Standard Code (including Standard 1.4.2) was further published in Gazette P 30 of 20 December 2000.

Part 2 Variations to Standard 1.4.2—Maximum Residue Limits

5 Variations to Standard 1.4.2

The Schedule to this Instrument sets out the variations made to the Principal Instrument by this Amendment Instrument.

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Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code

Schedule

Variations to Standard 1.4.2—Maximum Residue Limits

1 Variations

(1) The Principal Instrument is varied by:

(a) omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –

Pirimicarb

Sum of pirimicarb, demethyl-pirimicarb and the N-formyl-(methylamino) analogue (demethylformamido-

pirimicarb), expressed as pirimicarb

Vegetables [except adzuki bean (dry); celeriac; leafy vegetables; lupin (dry); mung bean (dry); onion, Welsh; shallot; soya bean (dry); spring onion; sweet corn (corn-on-the-cob)]

1

Pymetrozine

Pymetrozine

Leafy vegetables [except mizuna] T5

(b) inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals –

Acifluorfen

Acifluorfen

Chia T*0.01

Difenoconazole

Difenoconazole

Poppy seed T*0.01

Pirimicarb Sum of pirimicarb, demethyl-pirimicarb and the N-

formyl-(methylamino) analogue (demethylformamido-pirimicarb), expressed as pirimicarb

Celery T15

Vegetables [except adzuki bean (dry); celeriac; celery; leafy vegetables; lupin (dry); mung bean (dry); onion, Welsh; shallot; soya bean (dry); spring onion; sweet corn (corn-on-the-cob)]

1

Pymetrozine

Pymetrozine

Leafy vegetables T5

Sedaxane

Sedaxane, sum of isomers

Poppy seed T*0.01

(c) omitting from Schedule 1, under the entries for the following chemicals, the maximum residue limit for the food, substituting –

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Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code

Benzyladenine

Benzyladenine

Pear *0.005

Dimethoate

Sum of dimethoate and omethoate, expressed as dimethoate

see also Omethoate

Egg plant T0.2

Fluopyram

Commodities of plant origin: Fluopyram Commodities of animal origin: Sum of fluopyram and

2-(trifluoromethyl)-benzamide, expressed as fluopyram

Almonds 0.05

Cherries 3

Edible offal (mammalian) 0.2

Meat (mammalian) *0.02

Milks *0.02

Pome fruits 0.5

Stone fruits [except cherries] 2

Penflufen

Penflufen

Potato *0.01

Pirimicarb Sum of pirimicarb, demethyl-pirimicarb and the N-

formyl-(methylamino) analogue (demethylformamido-pirimicarb), expressed as pirimicarb

Onion, Welsh T7

Shallot T7

Spring onion T7

Terbuthylazine

Terbuthylazine

Cotton seed 0.01

Trifloxystrobin

Sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)-

ethylideneaminooxymethyl]phenyl] acetic acid), expressed as trifloxystrobin equivalents

Almonds 0.05

Stone fruits 5