Commonwealth of Australia	Gazette	
No. APVMA 8, Tuesday, 21 April 2015
Published by The Australian Pesticides  and Veterinary Medicines Authority	Agricultural and Veterinary Chemicals	
Australian Government
	
Australian Pesticides and Veterinary Medicines Authority
The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. 
The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be published in the Gazette containing details of the registration of agricultural and veterinary chemical products and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.
ISSN 1837 - 7629
 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: communications@apvma.gov.au 
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/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.

CONTENTS
Agricultural Chemical Products and Approved Labels
Veterinary Chemical Products and approved labels
Approved Active Constituents
New Agricultural Active Constituent Approved Under Section 14a—Rosemary Oil
New Agricultural Active Constituent approved under Section 14a—Cedar Oil
Licensing of Veterinary Chemical Manufacturers
Amendments to the APVMA MRL Standard
Proposal to Amend Standard 1.4.2 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.	Restricted Product
Application no.:	62938	
Product name:	Wellfarm Bifenthrin 100 EC Insecticide	
Active constituent/s:	100 g/L bifenthrin	
Applicant name:	Wellfarm Pty Ltd	
Applicant ACN:	158 518 551	
Summary of use	For installation of chemical soil barriers for new building work in accordance with AS 3660.1; the post-construction management of subterranean termites in accordance with AS 3660.2 and the control of a range of other urban pests	
Date of registration/approval:	2 April 2015	
Product registration no.:	70288	
Label approval no.:	70288/62938	

2.	agricultural Products Based on Existing Active Constituents

Application no.:	100032	
Product name:	Imark 700 WG Herbicide	
Active constituent/s:	700 g/kg imazapic	
Applicant name:	Shandong Rainbow International Co., Ltd	
Applicant ACN:	N/A	
Summary of use	For the pre-emergence control of certain annual grass and broadleaf weeds in fallow situations and sugarcane	
Date of registration/approval:	30 March 2015	
Product registration no.:	80013	
Label approval no.:	80013/100032	

Application no.:	63470	
Product name:	Bespray 500 Herbicide	
Active constituent/s:	500 g/L 2,4–DB (present as the dimethylamine salt)	
Applicant name:	Shandong Rainbow International Co., Ltd	
Applicant ACN:	N/A	
Summary of use	For the control of broadleaf weeds in seedling and established lucerne, medic and clover pasture, peanuts and cereal crops undersown with lucerne, medic or clover		
Date of registration/approval:	30 March 2015	
Product registration no.:	70446	
Label approval no.:	70446/63470	

Application no.:	62926	
Product name:	Wellfarm Lambda-Cyhalothrin 250 CS Insecticide	
Active constituent/s:	250 g/L lambda-cyhalothrin	
Applicant name:	Wellfarm Pty Ltd	
Applicant ACN:	158 518 551	
Summary of use	For the control of certain insect pests in cotton, barley, wheat and various field crops	
Date of registration/approval:	30 March 2015	
Product registration no.:	70282	
Label approval no.:	70282/62926	

Application no.:	100901	
Product name:	Brunnings Citrus & Fruit Spray	
Active constituent/s:	20 g/L petroleum oil	
Applicant name:	Brunnings Garden Products Pty Ltd	
Applicant ACN:	050 655 760	
Summary of use	For the control of scale on citrus, roses and ornamentals	
Date of registration/approval:	30 March 2015	
Product registration no.:	80462	
Label approval no.:	80462/100901	

Application no.:	62459	
Product name:	Farmalinx Quinfen 250 SC Fungicide	
Active constituent/s:	250 g/L quinoxyfen	
Applicant name:	Farmalinx Pty Ltd	
Applicant ACN:	134 353 245	
Summary of use	For use as a protectant against powdery mildew in grapevines	
Date of registration/approval:	30 March 2015	
Product registration no.:	70081	
Label approval no.:	70081/62459	

Application no.:	62690	
Product name:	Wellfarm Trifluralin 480 EC Herbicide	
Active constituent/s:	480 g/L trifluralin	
Applicant name:	Wellfarm Pty Ltd	
Applicant ACN:	158 518 551	
Summary of use	For the pre-emergent control of annual grasses and certain broadleaf weeds in certain horticultural and agricultural crops	
Date of registration/approval:	31 March 2015	
Product registration no.:	70183	
Label approval no.:	70183/62690	

Application no.:	62674	
Product name:	Pilar-2,4-D 625 SL Herbicide	
Active constituent/s:	625 g/L 2,4–D present as the dimethylamine and diethanolamine salt	
Applicant name:	Pilarquim (Shanghai) Co Ltd	
Applicant ACN:	N/A	
Summary of use	For the control of broadleaf weeds in fallow before direct drilling or sowing of cereals and pastures; and in cereal crops, pastures, sugarcane, peanuts, and non-agricultural areas	
Date of registration/approval:	31 March 2015	
Product registration no.:	70174	
Label approval no.:	70174/62674	

Application no.:	63336	
Product name:	Hy-Clor Super Algaecide	
Active constituent/s:	400 g/L benzalkonium chloride	
Applicant name:	Hy-Clor (Australia) Pty Ltd	
Applicant ACN:	000 655 381	
Summary of use	For the control of algae in swimming pools	
Date of registration/approval:	31 March 2015	
Product registration no.:	70386	
Label approval no.:	70386/63336	

Application no.:	62935	
Product name:	GOKU Growth Regulator	
Active constituent/s:	720 g/L ethephon (an anti-cholinesterase compound)	
Applicant name:	Proplan Plant Protection Company S.L	
Applicant ACN:	N/A	
Summary of use	For anti-lodging in barley or crop thinning, loosening or ripening in various crops and for accelerating boll opening, defoliation and pre-conditioning before defoliation of cotton	
Date of registration/approval:	31 March 2015	
Product registration no.:	70287	
Label approval no.:	70287/62935	

Application no.:	63489	
Product name:	Hammersley Litter Beetle Insecticide	
Active constituent/s:	12.75 g/L eucalyptus oil, 7.65 g/L tea tree oil	
Applicant name:	Hammersley Industries Pty Limited	
Applicant ACN:	001 919 973	
Summary of use	To assist control of lesser mealworm (alphitobius diaperinus) in poultry sheds	
Date of registration/approval:	31 March  2015	
Product registration no.:	70464	
Label approval no.:	70464/63489	

Application no.:	63472	
Product name:	Peroxsil395 Chlorine Free Pool Sanitiser	
Active constituent/s:	395 g/L hydrogen peroxide, 0.33 g/L silver as silver nitrate	
Applicant name:	Waterco Limited	
Applicant ACN:	002 070 733	
Summary of use	For control of bacteria and algae in private (domestic) swimming pools and spas	
Date of registration/approval:	1 April 2015	
Product registration no.:	70448	
Label approval no.:	70448/63472	

Application no.:	101171	
Product name:	Weed Force Evict 700 Herbicide	
Active constituent/s:	700 g/kg glyphosate (present as the mono-ammonium salt)	
Applicant name:	Weed Force Pty Ltd	
Applicant ACN:	602 207 152	
Summary of use	For use as a non-selective herbicide in various situations	
Date of registration/approval:	1 April 2015	
Product registration no.:	80586	
Label approval no.:	80586/101171	

Application no.:	100947	
Product name:	Pest Defence Rat & Mouse Block Bait	
Active constituent/s:	0.05 g/kg brodifacoum	
Applicant name:	Zapi S.P.A	
Applicant ACN:	N/A	
Summary of use	For the control of rodents resistant to other anticoagulants, including warfarin, coumatetralyl and bromadiolone	
Date of registration/approval:	1 April 2015	
Product registration no.:	80485	
Label approval no.:	80485/100947	

Application no.:	101172	
Product name:	Weed Force Longreach Herbicide	
Active constituent/s:	900 g/kg simazine	
Applicant name:	Weed Force Pty Ltd	
Applicant ACN:	602 207 152	
Summary of use	For use in commercial and industrial areas, around agricultural buildings, fence lines, rights of way, forestry and a range of horticultural and broadacre crops to control certain annual and perennial weeds	
Date of registration/approval:	2 April 2015	
Product registration no.:	80587	
Label approval no.:	80587/101172	

Application no.:	101001	
Product name:	Pest Defence Rat & Mouse Soft Bait	
Active constituent/s:	0.05 g/kg brodifacoum	
Applicant name:	Zapi S.P.A	
Applicant ACN:	N/A	
Summary of use	For effective control of rodents around industrial, commercial, agricultural and residential buildings. Controls rodents resistant to other anticoagulants, including warfarin, coumatetralyl and bromadiolone	
Date of registration/approval:	7 April 2015	
Product registration no.:	80508	
Label approval no.:	80508/101001	

Application no.:	100886	
Product name:	Whitestar Flutriafol SC Fungicide	
Active constituent/s:	500 g/L flutriafol	
Applicant name:	Agricultural Product Services Pty Ltd	
Applicant ACN:	092 350 279	
Summary of use	For control of certain fungal diseases on wheat, barley and canola when mixed with fertiliser	
Date of registration/approval:	7 April 2015	
Product registration no.:	80450	
Label approval no.:	80450/100886	

Application no.:	62664	
Product name:	Wellfarm 2,4–D Amine 625 SL Herbicide	
Active constituent/s:	625 g/L 2,4–D present as the dimethylamine and diethanolamine salts	
Applicant name:	Wellfarm Pty Ltd	
Applicant ACN:	158 518 551	
Summary of use	For the control of broadleaf weeds in fallow before direct drilling or sowing of cereals and pastures; and in cereal crops, pastures, sugarcane, peanuts, and non-agricultural areas	
Date of registration/approval:	7 April 2015	
Product registration no.:	70166	
Label approval no.:	70166/62664	
3.	Variations of registration 

Application no:	101950	
Product name:	Strident Insecticide	
Active constituent/s:	440 g/L buprofezin	
Applicant name:	Cheminova Australia Pty Limited 	
Applicant ACN:	110 199 169	
Summary of variation:	To change the product name from ‘PATRON INSECTICIDE’ to ‘STRIDENT INSECTICIDE’	
Date of variation:	13 March 2015	
Product registration no.:	62616	
Label approval no.:	62616/101950	

Application no:	101962	
Product name:	Yates Weed N' Feed Hose On	
Active constituent/s:	2.3 g/L dicamba present as the dimethylamine salt, 15 g/L MCPA present as the dimethylamine salt	
Applicant name:	Duluxgroup (Australia) Pty Ltd	
Applicant ACN:	000 049 427	
Summary of variation:	To change the product name from ‘YATES DOUBLE ACTION WEED'N'FEED LIQUID’ to ‘YATES WEED N' FEED HOSE ON’	
Date of variation:	16 March 2015	
Product registration no.:	67217	
Label approval no.:	67217/101962	

Application no:	62534	
Product name:	Temprid 75 Residual Insecticide	
Active constituent/s:	50 g/L imidacloprid, 25 g/L beta-cyfluthrin	
Applicant name:	Bayer CropScience Pty Ltd	
Applicant ACN:	000 226 022	
Summary of variation:	To include control of a range of insects in turf and ornamentals and add a pack size range (0.5 L—10 L)	
Date of variation:	31 March 2015	
Product registration no.:	64371	
Label approval no.:	64371/62534	

Application no:	100398	
Product name:	Senator 600 Red Flowable Seed Treatment	
Active constituent/s:	600 g/L imidacloprid	
Applicant name:	Crop Care Australasia Pty Ltd	
Applicant ACN:	061 362 347	
Summary of variation:	To update registration details and to include protection against insect pests of stored cereal grain	
Date of variation:	1 April 2015	
Product registration no.:	61163	
Label approval no.:	61163/100398	

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.:	100936	
Product name:	Paragard Allwormer Tablets For Large Dogs	
Active constituent/s:	100 mg praziquantel, 450 mg oxibendazole	
Applicant name:	Merial Australia Pty Ltd	
Applicant ACN:	071 187 285	
Summary of use	To treat and control roundworm, hookworm, whipworm and tapeworm in large dogs	
Date of registration/approval:	1 April 2015	
Product registration no.:	80476	
Label approval no.:	80476/100936	

Application no.:	100937	
Product name:	Paragard Allwormer Tablets For Small Dogs And Puppies	
Active constituent/s:	25 mg praziquantel, 112.5 mg oxibendazole	
Applicant name:	Merial Australia Pty Ltd	
Applicant ACN:	071 187 285	
Summary of use	For the treatment and control of roundworm, hookworm, whipworm and 
tapeworm in small dogs and puppies	
Date of registration/approval:	1 April 2015	
Product registration no.:	80477	
Label approval no.:	80477/100937	

Application no.:	100938	
Product name:	Paragard Allwormer Tablets For Medium Dogs	
Active constituent/s:	50 mg praziquantel, 225 mg oxibendazole	
Applicant name:	Merial Australia Pty Ltd	
Applicant ACN:	071 187 285	
Summary of use	To treat and control roundworm, hookworm, whipworm and tapeworm in medium dogs	
Date of registration/approval:	2 April 2015	
Product registration no.:	80478	
Label approval no.:	80478/100938	

Application no.:	59748	
Product name:	RevitaCAM 5mg/mL Oromucosal Spray for Dogs	
Active constituent/s:	5 mg/mL meloxicam	
Applicant name:	Abbott Laboratories	
Applicant ACN:	N/A	
Summary of use	For the alleviation of inflammation and pain in acute and chronic musculoskeletal disorders in dogs	
Date of registration/approval:	7 April 2015	
Product registration no.:	69059	
Label approval no.:	69059/59748	

2.	Variations of registration 
Application no.:	100037	
Product name:	Voren Dexamethasone Ester for Injection	
Active constituent/s:	1 mg/ml dexamethasone isonicotinate	
Applicant name:	Boehringer Ingelheim Pty Limited, Vetmedica Division	
Applicant ACN:	000 452 308	
Summary of variation:	To remove use in cattle, sheep and pigs and intravenous dosage instruction	
Date of variation:	7 April 2015	
Product registration no.:	35959	
Label approval no.:	35959/100037	

Approved Active Constituents
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of the approval of the following active constituents, with effect from the dates shown.
1.	active consitutent
Application no.:	80007	
Active constituent/s:	Propyzamide	
Applicant name:	Shandong Rainbow International Co., Ltd	
Applicant ACN:	N/A	
Summary of use:	For use in agricultural chemical products	
Date of approval:	31 March 2015	
Approval no.:	80007/100027	

New Agricultural Active Constituent Approved Under Section 14a—Rosemary Oil
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is proposing to add Rosemary oil to the list of Active Constituents Not Requiring Evaluation. Rosemary oil has been evaluated and has met the criteria under Section 14A of the Agvet Code.
Rosemary oil is listed on the US-EPA list of pesticides: Minimum Risk Exemptions. The following link is to the US-EPA www.regulations.gov/ Document ID: EPA-HQ-OPP-2010-0305-0006.
Rosemary oil is not toxicologically significant to humans: Journal of Food Protection, Vol. 71, No. 4, 2008, Pages 790–795 International Association for Food Protection.
The APVMA is satisfied of Section 14A(b) of the Agvet Code, which refers to having regard to matters (relevant matters) mentioned in subsection 14(4), specifically (a), (b), (c), (d), (e).

Common Name:			Rosemary oil
Scientific Information:		Extracted from Rosmarinum officinalis, Labiatae.
Making a Submission
In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission to the proposal to include Rosemary oil on the list of Active Constituents Not Requiring Evaluation. Submissions should relate only to matters that the APVMA is required by legislation to consider in deciding whether to grant the approval via the section 14A route. These grounds include chemistry and manufacture, and toxicity. Submissions should state the grounds on which they are based. Comments received outside these grounds cannot be considered by the APVMA. 
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact below. All submissions to the APVMA will be acknowledged in writing via email or by post. A summary of relevant comments and the APVMA’s response will be published on the APVMA website.
When making a submission please include a:
•	contact name
•	company or group name (if relevant)
•	postal address
•	email address (if available)
•	the date you made the submission.
All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially.

Written submissions on the APVMA’s proposal to grant approval for clove oil that relate to the grounds for approval should be marked attention to the Director, Chemistry and Manufacture Section, Scientific Assessment and Chemical Review Program in writing to:
The Director
Chemistry and Manufacture Section
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4936
Fax:	+61 2 6210 4840
Email:	chemistry@apvma.gov.au 

New Agricultural Active Constituent approved under Section 14a—Cedar Oil
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is proposing to add Cedar oil to the list of Active Constituents Not Requiring Evaluation. Cedar oil has been evaluated and has met the criteria under Section 14A of the Agvet Code.
Cedar oil is an extract from the Cupressaceae family, which includes true cedars, junipers, and cypresses. As a biochemical active ingredient, products containing Cedar oil are approved as repellents in the United States of America. A non-toxic mode of action has been confirmed and risk assessments have accounted for the potential hazards posed by each use. Information submitted in support of USA registered products containing Cedar oil uniformly confirms that no adverse human health or ecological risk are expected as a result of exposure to this compound, when used according to label directions. 
The following link to the US-EPA toxicology document was used in determining the toxicology of Cedar oil http://southwesterncedaroil.com/downloads/EPA_Cedar_Oil_Report.pdf
Cedar oil is not toxicologically significant to humans.
The APVMA is satisfied of Section 14A(b) of the Agvet Code, which refers to having regard to matters (relevant matters) mentioned in subsection 14(4), specifically (a), (b), (c), (d), (e).
Common Name:			Cedar oil
Scientific Information:		Cedar oil is an extract from the Cupressaceae family
Making a Submission
In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission to the proposal to include Cedar oil on the list of Active Constituents Not Requiring Evaluation. Submissions should relate only to matters that the APVMA is required by legislation to consider in deciding whether to grant the approval via the section 14A route. These grounds include chemistry and manufacture, and toxicity. Submissions should state the grounds on which they are based. Comments received outside these grounds cannot be considered by the APVMA.
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact below. All submissions to the APVMA will be acknowledged in writing via email or by post. A summary of relevant comments and the APVMA’s response will be published on the APVMA website.
When making a submission please include a:
•	contact name
•	company or group name (if relevant)
•	postal address
•	email address (if available)
•	the date you made the submission
All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially.
Written submissions on the APVMA’s proposal to grant approval for Cedar oil that relate to the grounds for approval should be marked attention to the Director, Chemistry and Manufacture Section, Scientific Assessment and Chemical Review in writing to:
The Director
Chemistry and Manufacture Section
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4936
Fax:	+61 2 6210 4840
Email:	chemistry@apvma.gov.au 

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]
CCD Animal Health Pty Ltd	LICENCE NO: 6195	
ACN: 151 737 950
Unit 16
84–92 Barnes Street
TAMWORTH NSW 2340	Product Types:*	
	•	Category 6: Single step manufacture	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, filling, packaging, sachet packaging, labelling, storage and release for supply.	
	Licence Issued: 2 February 2015 	
eimeria pty. limited	LICENCE NO: 6157	
ACN: 075 153 472
University of Melbourne
School of Veterinary Sciences
250 Princes Highway
WERRIBEE  VIC  3030
	Product Types:*	
	•	Category 6: Single step manufacture	
	Step(s) of Manufacture: Analysis and testing (immunobiological)	
	Licence Issued: 24 February 2015	
Dermcare-Vet Pty. Ltd.	LICENCE NO: 1109	
ACN: 010 280 010
7 Centenary Road
Slacks Creek, QLD 4127	Product Types: *	
	•	Category 1: Sterile and immunobiological products 	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, aseptic filling, packaging, labelling, analysis and testing (physical), storage and release for supply	
	Licence Issued: 10 March 2015 	

WSD AGRIBUSINESS PTY. LTD.	LICENCE NO: 2231	
ACN:  600 111 135
7 Koojan Avenue 
SOUTH GUILFORD,  PERTH  WA  6055
	Product Types: *	
	•	Category 2: powders and liquids
•	Category 3: liquids and powders
•	Category 4: premixes and supplements	
	Step(s) of Manufacture: Quality Assurance of raw materials, formulation including blending, filling, packaging, labelling, analysis and testing (physical), storage and release for supply.	
	Licence Issued: 13 March 2015	
Landmark Operations Limited	LICENCE NO: 6202	
ACN: 008 743 217
71 Colebard Street West
ACACIA RIDGE QLD 4110	Product Types:*	
	•	Category 6: Single step manufacture	
	Step(s) of Manufacture: secondary packaging, secondary labelling, storage and release for supply	
	Licence Issued: 23 March 2015	
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
Equivet Pty. Limited	LICENCE NO: 2034	
ACN: 003 837 492
37 Lord Fury Court
DARLING DOWNS WA 6122	Product Types: *	
	•	Category 2: Pastes, powders	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, storage and release for supply.	
	Amended Licence Issued: 2 February 2015 	

CUSTOM CHEMICALS INTERNATIONAL PTY LTD	LICENCE NO: 3030	
ACN:  050 573 674
103–107 Potassium St
NARANGBA QLD 4504
	Product Types: *	
	•	Category 3: Liquids and sprays	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, analysis and testing (physical), storage and release for supply.	
	Amended Licence Issued: 9 February 2015 	

bioproperties pty. ltd.	LICENCE NO: 1061	
ACN: 007 303 728
11–15 Moores Road
GLENORIE  NSW  2157	Product Types: *	
	•	Category 1: Immunobiologicals, sterile diluents	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, management of donor animals, virus cultivation, mycoplasma cultivation, bacterial fermentation, oocyst antigen production, oocyst processing, formulation including blending, aseptic filling, filling, packaging, labelling, microbiological reduction treatment (heat, chemical, filtration), sterilisation (heat, chemical, filtration), freeze-drying, analysis and testing (physical, immunobiological, microbiological, oocyst counts), storage and release for supply.	
	Amended Licence Issued: 23 February 2015 	
Australian Contract Manufacturing (ACM) Pty Ltd	LICENCE NO: 2065	
ACN: 052 052 196
92 Antimony Street
CAROLE PARK QLD 4300	Product Types: *	
	•	Category 2: tablets, creams/lotions, ointments, pastes, powders, sprays and liquids
•	Category 3: liquids, pastes, sprays and powders
•	Category 4: liquids, powders and pastes	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, dry milling of powders, granulation, wet milling of powders, packaging, labelling, strip, blister or sachet packaging, tableting, tablet coating, analysis and testing (physical), storage and release for supply	
	Amended Licence Issued: 2 March 2015 	

boehringer ingelheim pty ltd	LICENCE NO: 6187	
ACN: 000 452 308
Level 1, 78 Waterloo Road
NORTH RYDE NSW 2113	Product Types: *	
	•	Category 6: Single step manufacture	
	Step(s) of Manufacture: Release for supply	
	Amended Licence Issued: 10 March 2015 	
TREIDLIA BIOVET PTY LTD	LICENCE NO: 1096	
ACN:  150 496 138
Unit 76, Power Business Park
45 Powers Road
SEVEN HILLS  NSW 2147
	Product Types:*	
	•	Category 1: Immunobiologicals (Inactivated autogenous or minor use bacterial, fungal and wart vaccines)
	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, bacterial fermentation, fungal fermentation, wart tissue extraction, formulation including blending, filling, aseptic filling, packaging, labelling, sterilisation (heat, chemical and filtration), microbiological reduction treatment (heat, filtration and chemical), analysis and testing (physical, chemical, microbiological and sterility testing), storage and release for supply.	
	Amended Licence Issued: 10 March 2015	
Austasia animal products pty ltd	LICENCE NO: 4090	
ACN: 083 458 566
29 Wongajong Road
FORBES NSW 2871	Product Types: *	
	•	Category 4: Premixes and supplements	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, dry milling, packaging, labelling, pellet extrusion, storage and release for supply.	
	Amended Licence Issued: 13 March 2015 	
CCD Animal health pty ltd	LICENCE NO: 6195	
ACN: 151 737 950
Unit 16
84–92 Barnes Street
TAMWORTH NSW 2340	Product Types: *	
	•	Category 6: Single step manufacture	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, filling, packaging, sachet packaging, labelling, storage and release for supply.	
	Amended Licence Issued: 24 March 2015 	

baxter healthcare pty ltd	LICENCE NO: 1026	
ACN: 000 392 781
1 Baxter Drive 
OLD TOONGABBIE NSW 2146	Product Types: *	
	•	Category 1: Sterile products (liquids)	
	Step(s) of Manufacture: Formulation including blending, filling, packaging, labelling, sterilisation (heat), analysis and testing (physical, chemical, Limulus Amoebocyte Lysate test [LAL] and microbiological), storage and release for supply.	
	Amended Licence Issued: 30 March 2015 	
Starward Pty Ltd trading as INline Cosmetic Laboratories	LICENCE NO: 2198	
ACN: 120 276 995
28 Horizon Drive
BEENLEIGH QLD 4207	Product Types: *	
	•	Category 2: creams/lotions, ointments, pastes, sprays and liquids	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, analysis and testing (physical), storage and release for supply.	
	Amended Licence Issued: 31 March 2015 	
3.	LICENCE CANCELLATIONS
The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].
National chemical pty ltd	LICENCE NO: 2155	
ACN: 077 738 740
262 Evans Road
Salisbury QLD 4107	Date Cancelled: 27 February 2015	
		
G S Packaging Pty Ltd	LICENCE NO: 6185	
ACN: 160 337 011
1/137 Long Street
SMITHFIELD NSW 2164	Date Cancelled: 12 March 2015	

Royal Melbourne Institute of Technology Trading as RMIT University	LICENCE NO: 1060	
ABN: 49 781 030 034
Department of Biotechnology and Environmental Biology
Level 1, Building 223
RMIT University (Bundoora Campus)
Plenty Road
BUNDOORA VIC 3083	Date Cancelled: 24 March 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].
Nil
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
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone:	+61 2 6210 4899
Fax:	+61 2 6210 4813
Email:	mls@apvma.gov.au 
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 effect 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. 3).
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:	enquiries@apvma.gov.au  

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. 3)) 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.

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. 3))
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 with the associated chemical definitions—

Fluopyram	
Commodities of plant origin:  Fluopyram
Commodities of animal origin for enforcement:  Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyram
Commodities of animal origin for dietary exposure assessment:  Sum of fluopyram, 2-(trifluoromethyl) benzamide and the combined residues of N-{(E)-2-[3-chloro-5-(trifluoromethyl)pyridin-2-yl]ethenyl}-2-(trifluoromethyl) benzamide and N-{(Z)-2-[3-chloro-5-(trifluoromethyl)pyridin-2-yl]ethenyl}-2-(trifluoromethyl) benzamide, all expressed as fluopyram	

Fluopyram	
Fluopyram	

2.	inserting in alphabetical order in Schedule 1—

Fenpyrazamine	
Fenpyrazamine	
Dried grapes (currants, raisins and sultanas)	20	
Edible offal (mammalian)	*0.01	
Eggs	*0.01	
Meat (mammalian)	*0.01	
Milks	*0.005	
Poultry, edible offal of	*0.01	
Poultry meat	*0.01	
Table grapes	5	
Wine grapes	0.05	

Fluopyram	
Commodities of plant origin:  Fluopyram
Commodities of animal origin:  Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyram 	
Almonds	T0.5	
Banana	0.1	
Cherries 	T5	
Dried grapes (currants, raisins and sultanas) 	15	
Edible offal (mammalian)	T0.7	
Grapes	2	
Hops, dry	100	
Meat (mammalian)	T0.05	
Milks	T0.2	
Pome fruits	T0.5	
Stone fruits [except cherries]	T2	

3.	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	
Fruiting vegetables, cucurbits [except cucumber and squash, Summer]	T*0.01	
Litchi	T0.05	
		
Azoxystrobin	
Azoxystrobin	
Oats	0.1	
		
Difenoconazole	
Difenoconazole	
Coriander (leaves, stems, roots)	T20	
		
Mandipropamid	
Mandipropamid	
Leafy vegetables	T20	

Sulfoxaflor	
Sulfoxaflor	
Persimmon, Japanese	T1	

4.	omitting from 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	
Melons, except watermelon	T0.02	
Watermelon	T0.02	

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

Azoxystrobin	
Azoxystrobin	
Barley	0.2	
Wheat	0.1	
		
Cyfluthrin	
Cyfluthrin, sum of isomers	
Litchi	T0.3	
		
Difenoconazole	
Difenoconazole	
Parsley	T20	

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) 19 May 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:	enquiries@apvma.gov.au