APVMA Gazette no. 1, 15 January 2013

No. APVMA 1, Tuesday, 15 January 2013

Published by The Australian Pesticides & Veterinary Medicines Authority

AGRICULTURAL AND

VETERINARY CHEMICALS

The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The

Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be

published in the Gazette containing details of the registration of agricultural and veterinary chemical products

and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code

and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet

Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.

ISSN 1837 - 7629

Commonwealth of Australia Gazette No. APVMA 1, Tuesday, 15 January 2013 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2013

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

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 granted by the APVMA, notices as requi red

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 53(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 4871

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

mailto:[email protected]

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

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


CONTENTS

Notice of Registrations 4 Agricultural Chemical Products .............................................................................................................................................. 4 Veterinary Chemical Products .............................................................................................................................................. 11

Notice – New Agricultural Chemical Products 15 312 g/Kg metofluthrin in the product Off! Clip-On Mosquito Repellent ................................................................................. 15

Other Notices 19 Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code ............................................................. 19 Addendum to the Record of Approved Active Constituents .................................................................................................. 24 Application Summaries ......................................................................................................................................................... 26


Notice of Registrations – Agricultural Chemical Products

NOTICE OF REGISTRATIONS

Agricultural Chemical Products

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 registration in respect of the following

products, with effect from the dates shown.

1. AGRICULTURAL PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS

Product Name: EverGol Prime Seed Treatment

Active Constituent/s: 240g/L penflufen

Applicant Name: Bayer Cropscience Pty Ltd

Applicant ACN: 000 226 022

Summary of Use: For suppression of Rhizoctonia root rot and control or suppression of smut diseases of wheat and barley

Date of Registration: 19 December 2012

Label Approval No: 64744/49879

2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: Preminator Termiticide

Active Constituent/s: 200g/L imidacloprid

Applicant Name: Imaspro Resources SDN BHD

Applicant ACN: N/A

Summary of Use: For use in the management of subterranean termites



Product Name: FMC Triclopyr 600 Herbicide

Active Constituent/s: 600g/L triclopyr present as the butoxyethyl ester

Applicant Name: FMC Australasia Pty Ltd


Summary of Use: For the control of various woody and broadleaf weeds



Product Name: Chaochen Glyphosate 700 SG Herbicide

Active Constituent/s: 700g/kg glyphosate present as the mono-ammonium salt

Applicant Name: Jiangyin No 2 Pesticides Co., Ltd

Applicant ACN: N/A

Summary of Use: For the control of many annual and perennial weeds in certain situations



Product Name: Chaochen Glyphosate 450 SL Herbicide

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

Applicant Name: Jiangyin No 2 Pesticides Co., Ltd

Applicant ACN: N/A

Summary of Use: For use as non-residual herbicide for the control of a broad range of annual, perennial and woody weeds and for the use in conservation tillage





Product Name: EzyCrop Glyphosate 510SL Herbicide

Active Constituent/s: 510g/L glyphosate present as the isopropylamine salt

Applicant Name: EzyCrop Pty Ltd


Summary of Use: For the control of a wide range of annual and perennial weeds in a wide variety of situations



Product Name: Novaguard Bifenthrin 100 EC Insecticide And Miticide

Active Constituent/s: 100g/L bifenthrin

Applicant Name: Novaguard Pty Ltd


Summary of Use: For installing chemical soil barriers for new building work in accord with AS 3660.1; the post -construction management of subterranean termites in accord with AS 3660.2, and the control of a range of urban pests in urban and domestic situations



Product Name: Accensi 2,4-D / Picloram Herbicide

Active Constituent/s: 75g/L picloram present as the triisopropanolamine salt, 300g/L 2,4-D present as the triisopropanolamine salt

Applicant Name: Accensi Pty Ltd


Summary of Use: For the control of a wide range of annual and perennial broadleaf weeds



Product Name: DualiS 960 EC Herbicide

Active Constituent/s: 960g/L S-metolachlor

Applicant Name: United Phosphorus Ltd.


Summary of Use: For the control of a range of annual grasses and broadleaf weeds in a range of crops



Product Name: Hovex Germgard Flea Control Bomb

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

Applicant Name: Pascoe's Pty Ltd


Summary of Use: For use in the home to control fleas



Product Name: Novaguard Paraquat-Diquat 250 Herbicide

Active Constituent/s: 115g/L diquat present as diquat dibromide, 135g/L paraquat present as paraquat dichloride



Summary of Use: For the control of a wide range of grasses and broadleaf weeds





Product Name: EzyCrop Propyzamide 500 SC Herbicide

Active Constituent/s: 500g/L propyzamide



Summary of Use: For selective control of certain grasses and broadleaf weeds in lettuce, sports turf, home lawns and legumes, seed crops and pastures



Product Name: Vita 500 Herbicide

Active Constituent/s: 500g/L tri-allate

Applicant Name: Hextar Chemicals Pty Ltd


Summary of Use: For the control of wild oats in wheat, triticale, chickpeas, barley, peas, linseed, lupins, canola (rapeseed), faba beans and safflower and for control of a range of grass and broadleaf weeds in no-till/min-till cropping systems, pre-sowing or incorporated by sowing (IBS)



Product Name: EzyCrop Clethodim 240 Herbicide

Active Constituent/s: 240g/L clethodim.



Summary of Use: For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas, cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans



Product Name: Farmalinx Stuka Flexi Herbicide

Active Constituent/s: 240g/L picloram present as the potassium salt

Applicant Name: Farmalinx Pty Ltd


Summary of Use: For the control of various annual and perennial weeds in cereals, pastures and fallow situations



Product Name: Hovex Germgard Insect Control Bomb

Active Constituent/s: 0.77g/kg fenoxycarb, 10g/kg permethrin.

Applicant Name: Pascoe's Pty Ltd


Summary of Use: For the control of cockroaches, fleas, spiders, moths, carpet beetles and ants in home and garden situations



Product Name: Yates Complete Lawn Insect Control

Active Constituent/s: 15g/L imidacloprid, 3g/L beta-cyfluthrin

Applicant Name: Bayer Cropscience Pty Ltd


Summary of Use: For the control of armyworm, cutworm, webworm, curl grub and billbug larvae in domestic lawns





Product Name: Termatrix Termite Foam Insecticide

Active Constituent/s: 0.5g/kg imidacloprid

Applicant Name: Sherwood Chemicals Public Company Limited

Applicant ACN: N/A

Summary of Use: For control of termites



Product Name: SAS PRO Professional Granule Ant Killer

Active Constituent/s: 0.25 g/kg fipronil

Applicant Name: Sundew Solutions Pty Ltd


Summary of Use: For control of ants in turf, external surrounds of buildings and structures



Product Name: FMC Metolachlor 960 Herbicide

Active Constituent/s 960g/L metolachlor



Summary of Use: For the control of seed-borne & seedling root pathogens of peas, chickpeas, lentils, faba beans and vetch



Product Name: Novaguard Tebuconazole 430 SC Fungicide

Active Constituent/s: 430g/L tebuconazole



Summary of Use: For the control of leaf spot and leaf speckle on bananas; rust, leaf spot and net blotch of peanuts; foliar diseases on cereal crops; and other diseases on beans, peas, onions, pawpaw, pyrethrum and ryegrass and fescue seed crops



Product Name: FMC Omethoate 290 Miticide

Active Constituent/s: 290g/L omethoate (an anti-cholinesterase compound)



Summary of Use: For control of redlegged earth mite, blue oat mite and lucerne flea on pastures, cereals, oilseed and legume crops and bluegreen aphid and cowpea aphid on pasture legumes, lucerne, faba beans and vetch



Product Name: Agro-Essence Chlorpyrifos 500 Insecticide

Active Constituent/s: 500g/L chlorpyrifos (an anti-cholinesterase compound)

Applicant Name: Agro-Alliance (Australia) Pty Ltd


Summary of Use: For the control of certain insect pests of: cassava, cereals, forage crops, fruit, ginger, grapevines, hops, oilseed, pasture, pineapples, sugarcane, vegetable crops and other situations





Product Name: Transit Herbicide

Active Constituent/s: 300g/L clopyralid present as the triisopropanolamine salt

Applicant Name: Crop Care Australasia Pty Ltd


Summary of Use: For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures, fallow land, forests and industrial situations



Product Name: Novaguard Paraquat 250 SL Herbicide

Active Constituent/s: 250g/L paraquat present as paraquat dichloride



Summary of Use: For the control of a wide range of grasses and broadleaf weeds



Product Name: Pacific Tralkoxydim 400 WG Herbicide

Active Constituent/s: 400g/kg tralkoxydim

Applicant Name: Pacific Agriscience Pty Ltd


Summary of Use: For the control of wild oats and annual ryegrass and suppression of annual phalaris in wheat, barley, rye and triticale



Product Name: Genfarm Azoxystrobin 250 SC Fungicide

Active Constituent/s: 250g/L azoxystrobin

Applicant Name: Landmark Operations Limited


Summary of Use: For the control of various diseases of grapes, potatoes, tomatoes, cucurbits, avocados, mangoes, passionfruit and poppies



Product Name: Crop Care Sentry Herbicide

Active Constituent/s: 525g/kg imazapic, 175g/kg imazapyr

Applicant Name: Crop Care Australasia Pty Ltd


Summary of Use: For control of certain weeds in imidazolinone-tolerant canola and wheat



Product Name: Proteku Sulphur Dioxide Laminated Pads

Active Constituent/s: 240g/kg sodium metabisulphite

Applicant Name: E.E. Muir & Sons Pty Limited


Summary of Use: For the control of Botrytis in packaged grapes

Date of Registration: 4 January 2013




Product Name: Farmoz Triadex Selective Herbicide

Active Constituent/s: 500g/L triallate

Applicant Name: Farmoz Pty Limited


Summary of Use: For control of wild oats in wheat, triticale, chickpeas, barley, peas, linseed, lupins, canola (rapeseed), faba beans and safflower



Product Name: Mettle 40ME Fungicide

Active Constituent/s: 40g/L tetraconazole

Applicant Name: Isagro Australia Pty Limited


Summary of Use: For systemic control of powdery mildew on grapevines



Product Name: Nufarm Protector 400SC Fungicide

Active Constituent/s: 400g/L pyrimethanil

Applicant Name: Nufarm Australia Limited


Summary of Use: For the control of certain fungus diseases of fruit, field crops, tobacco, turf, vegetables and ornamentals



3. LISTED REGISTRATIONS

Product Name: Poolking Aqua Guard

Applicant Name: Agent Sales & Services Pty Ltd


Summary of Use: For control of bacteria, viruses and protozoa in swimming pools and spas


Product Number: 68308

4. VARIATIONS

Product Name: Roundup Attack Herbicide With IQ Inside

Applicant Name: Monsanto Australia Ltd


Summary of Variation: To extend the use to include a pre-harvest/cutting application in hay/silage and adding relevant use patterns from registered products

Date of Variation: 20 December 2012


Product Name: Antagonist Professional Residual Ant Insecticide

Active Constituent/s: 80g/L bifenthrin

Applicant Name: Sundew Solutions Pty Ltd


Summary of Use: For control of a range of ant species ants in external urban areas





Product Name: Intervix Herbicide For Clearfield Crops

Applicant Name: BASF Australia Ltd.


Summary of Variation: To include uses for Clearfield plus wheat and Clearfield barley and to instigate a 110L pack size

Date of Variation: 3 January 2013


Product Name: Mortein Rat Kill Professional Household Protection

Applicant Name: Reckitt Benckiser (Australia) Pty Limited


Summary of Variation: To change the product name from "MORTEIN RAT KILL HOUSEHOLD PROTECTION" to "MORTEIN RAT KILL PROFESSIONAL HOUSEHOLD PROTECTION" and update the label particulars



Product Name: Prospect Post Harvest Fruit Treatment

Applicant Name: Caltex Australia Petroleum Pty Ltd


Summary of Variation: To extend the post-harvest use for control of citrophilus mealybug in citrus



Product Name: EnviroMax Fipronil 100SC Termiticide & Insecticide

Applicant Name: EnviroMax Technologies Pty Ltd


Summary of Variation: To include uses in pre-construction situations via certain reticulation systems, foam application and to extend the period of protection to 8 years



Product Name: Protim Timbercare CN Timber Oil

Applicant Name: Osmose Australia Pty Ltd


Summary of Variation: To change the product name from 'PROTIM SOLIGNUM CN TIMBER OIL' to 'PROTIM TIMBERCARE CN TIMBER OIL' and to update the RLP’s




Notice of Registrations – Veterinary Chemical Products

Veterinary Chemical Products

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 registration in respect of the following

products, with effect from the dates shown.

5. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS

Product Name: Felimazole 2.5mg Coated Tablet

Active Constituent/s: 2.5mg thiamazole (methimazole)

Applicant Name: Dermcare-Vet Pty. Ltd


Summary of Use: For the stabilisation of feline hyperthyroidism as a pre-operative therapy and for the long-term treatment of feline hyperthyroidism



6. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: StrikeForce Spray-On Sheep Blowfly Treatment

Active Constituent/s: 50g/L dicyclanil

Applicant Name: Jurox Pty Limited


Summary of Use: Registration and approval of RLPs for a 50g/L dicyclanil spray-on product for the protection of sheep against blowfly strike



Product Name: Dormosedan Gel

Active Constituent/s: 7.6mg/mL detomidine hydrochloride

Applicant Name: Pfizer Animal Health Australia Pty Ltd


Summary of Use: For sedation and restraint in horses



Product Name: Moxitak Se Oral Drench For Sheep

Active Constituent/s: 1g/L moxidectin, 0.50 g/L selenium as sodium selenate

Applicant Name: Bayer Australia Ltd (Animal Health)


Summary of Use: For the control of moxidectin sensitive strains of gastro-intestinal helminths, lungworms and itchmite and to aid in the control of selenium responsive conditions in sheep



Product Name: Effipro Spot-On Solution For Cats

Active Constituent/s: 100g/L fipronil

Applicant Name: Virbac (Australia) Pty Ltd


Summary of Use: For the treatment and prevention of flea infestations and control of flea allergy dermatitis on cats





Product Name: Fensolve Anthelmintic For Cattle And Horses

Active Constituent/s: 100g/L fenbendazole

Applicant Name: Virbac (Australia) Pty Ltd


Summary of Use: For the control of Benzimidazole-sensitive mature and immature roundworms (including inhibited Ostertagia), lungworms and as an aid in the control of tapeworms in cattle. For the treatment and control of roundworms, bloodworms, redworms and pinworms in horses



Product Name: Theraspray 20 Iodophor Teat Sanitiser

Active Constituent/s: 20g/L available iodine

Applicant Name: Ecolab Pty Limited


Summary of Use: For use as an aid in the control of mastitis in cattle



Product Name: GSE Udder Emollient

Active Constituent/s: 643g/L sorbitol, 113g/L glycerol

Applicant Name: Ecolab Pty Limited


Summary of Use: For use in enhancing teat condition in cattle.



7. LISTED REGISTRATIONS

Product Name: Paw Pure Animal Wellbeing By Blackmores Osteocare Joint Health Chews

Applicant Name: Blackmores Limited


Summary of Variation: To change product name from "PAW PURE ANIMAL WELLBEING OSTEOCARE JOINT HEALTH CHEWS" to "PAW PURE ANIMAL WELLBEING BY BLACKMORES OSTEOCARE JOINT HEALTH CHEWS"


Product No: 65683

8. VARIATIONS

Product Name: Hill's Prescription Diet K/D Canine Renal Health

Applicant Name: Hill's Pet Nutrition Pty Limited


Summary of Variation: To change the name from ‘HILL'S PRESCRIPTION DIET K/D CANINE’ to ‘HILL'S PRESCRIPTION DIET K/D CANINE RENAL HEALTH’ and approval of label variation


Label Approval No: 36459/370g/1210

Product Name: Renal Canine

Applicant Name: Royal Canin Australia Pty Ltd


Summary of Variation: To change the product name from ‘RENAL’ to ‘RENAL CANINE’, approval of a pack size variation and variation to label approval





Product Name: Hill's Prescription Diet R/D Canine Weight Loss - Low Calorie



Summary of Variation: To change the name from ‘HILL'S PRESCRIPTION DIET R/D CANINE’ to ‘HILL'S PRESCRIPTION DIET R/D CANINE WEIGHT LOSS - LOW CALORIE’ and variation to the label approval



Product Name: Hill's Prescription Diet I/D Feline Gastrointestinal Health



Summary of Variation: To change the name from ‘HILL'S PRESCRIPTION DIET I/D FELINE’ to ‘HILL'S PRESCRIPTION DIET I/D FELINE GASTROINTESTINAL HEALTH’ and variation to label approval



Product Name: Equivac EST Equine Salmonella Typhimurium Vaccine



Summary of Variation: To change the immediate container from 5mL plastic syringe to 3mL glass syringe and variation to the product shelf life from 18 to 15 months when stored a 2-8

oC



Product Name: Hill's Prescription Diet S/D Feline Dissolution



Summary of Variation: To change the product name from 'HILL'S PRESCRIPTION DIET FELINE S/D CAN' to 'HILL'S PRESCRIPTION DIET S/D FELINE DISSOLUTION', approval of a pack size variation and variation to label approval



Product Name: Hill's Prescription Diet I/D Canine Gastrointestinal Health



Summary of Variation: To change the product name from ‘HILL'S PRESCRIPTION DIET I/D CANINE’ to ‘HILL'S PRESCRIPTION DIET I/D CANINE GASTROINTESTINAL HEALTH’ and variation to label approval



Product Name: Hill's Prescription Diet S/D Canine Dissolution



Summary of Variation: To change name from ‘HILL'S PRESCRIPTION DIET S/D CANINE’ to ‘HILL'S PRESCRIPTION DIET S/D CANINE DISSOLUTION ’ and variation to label approval





Product Name: Hill's Prescription Diet M/D Feline Weight Loss - Low Carbohydrate - Diabetic



Summary of Variation: To change the product name from 'HILL'S PRESCRIPTION DIET FELINE M/D CAN' to 'HILL'S PRESCRIPTION DIET M/D FELINE WEIGHT LOSS - LOW CARBOHYDRATE – DIABETIC' and variation to label approval



Product Name: Hill's Prescription Diet L/D Feline Hepatic Health

Applicant Name:

Applicant ACN:

Hill's Pet Nutrition Pty Limited

003 954 550

Summary of Variation: To change the product name from ‘HILL'S PRESCRIPTION DIET FELINE L/D CAN’ to ‘HILL'S PRESCRIPTION DIET L/D FELINE HEPATIC HEALTH’ and variation to label approval



Product Name: Hill's Prescription Diet A/D Canine/Feline Critical Care



Summary of Variation: To change name from ‘HILL'S PRESCRIPTION DIET CANINE/FELINE A/D ’ to ‘HILL'S PRESCRIPTION DIET A/D CANINE/FELINE CRITICAL CARE ’ and variation to label approval



Product Name: Eryvac Vaccine



Summary of Variation: To include the use of vaccine in lambs




Notice – New Agricultural Chemical Products – 312 g/Kg metofluthrin in the product Off! Clip-On Mosquito Repellent

NOTICE – NEW AGRICULTURAL CHEMICAL PRODUCTS

312 g/Kg metofluthrin in the product Off! Clip-On Mosquito Repellent

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from S.C. Johnson &

Son PTY LTD for registration of a new product containing the active constituent metofluthrin. The product is Off! Clip-On

Mosquito Repellent. The product is for use as a personal insect repellent.

PARTICULARS OF THE APPLICATION

Proposed Product Name(s): OFF! CLIP-ON MOSQUITO REPELLENT

Applicant Company: S.C. Johnson & Son PTY LTD

Name of Active Constituent: Metofluthrin

Signal Heading: Schedule 6

Summary of Proposed Use: Liquid vaporizer for use as a personal insect repellent

Pack Sizes: 46mg; 92mg

Withholding Period: Not applicable

SUMMARY OF THE APVMA’S EVALUATION OF OFF! CLIP-ON MOSQUITO REPELLENT IN ACCORDANCE WITH

SECTION 14(3)(E) AND (F) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (THE ‘AGVET

CODE’), SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994

The APVMA has evaluated the application and in its assessment in relation to human and environmental safety under

section 14(3)(e) of the Agvet Code, it proposes to determine that:

(i) The APVMA is satisfied that the proposed use of OFF! CLIP-ON MOSQUITO REPELLENT would not be an undue

hazard to the safety of people exposed to it during its handling and use.

The Office of Chemical Safety (OCS) in the Department of Health and Ageing has conducted a risk assessment on

the product and concluded that it can be used safely.

Metofluthrin is a synthetic pyrethroid insecticide. This class of chemicals act on the nervous system of insects,

disturbing the function of neurons by interacting with sodium channels. The product, Off! Clip-on Mosquito

Repellent containing metofluthrin at 322.6 g/L is a battery powered vaporizer device intended to be used as a

personal insect repellent for the control of flying insects. There are no proposed agricultural uses for metofluthrin.

The submitted studies on the active constituent in rats showed that following single and repeat-dose oral

administration of metofluthrin, absorption was rapid (detectable plasma residues within 30 min, Tmax 3-7 h) and

thorough (up to 80%). At 168 h post dosing, urinary and faecal excretion accounted for 10-26% and 30-56% of

the total administered dose, respectively. Absorbed metofluthrin was nearly completely metabolised, with some

unchanged metofluthrin detected in faeces, presumably representing unabsorbed compound. The highest level of

metofluthrin was found in the liver following single and repeat-dose administration and accumulation of radiocarbon

in the tissues was low. Thirty-three metabolites were identified, none of which were toxicologically significant. An

in vivo dermal absorption study in male rats indicated that metofluthrin is moderately absorbed through the skin.



Metofluthrin was found to be of low acute toxicity via the oral and dermal routes and of moderate toxicity via the

inhalational route in rats. Metofluthrin caused slight skin irritation, but was not an eye irritant, in rabbits. There is

no evidence of skin sensitisation potential for metofluthrin, as determined in guinea pigs.

Repeat-dose studies on metofluthrin indicated that the liver is the main target organ in rodents. Liver effects

common to most repeat-dose studies included: increased liver weight, incidence of dark and enlarged livers,

hepatocellular hypertrophy and biochemical changes. Other systemic effects noted in mice, rats, rabbits and dogs

following exposure to metofluthrin were decreased bodyweight and bodyweight gain, decreased food consumption

and symptoms of neurotoxicity, which is expected for pyrethroid insecticides.

Metofluthrin was not mutagenic or genotoxic in vitro, or genotoxic in vivo. Metofluthrin was found to be

carcinogenic in the liver in a long term study in rats, but was not carcinogenic in a long term study in mice.

However, it is considered that metofluthrin induced liver tumours in the rat via a mode of action that is similar to

phenobarbital and is not relevant to humans.

In rats, metofluthrin did not affect reproductive performance or the reproductive system. Metofluthrin was not a

developmental toxicant in rats or rabbits.

The applicant indicated that the toxicity of the end-use product is the same as that of the active constituent and did

not provide a separate dossier for the acute toxicity studies of the product.

The OCS considered the formulation of the proposed product, and agreed that because metofluthrin will be

dispersed directly onto an inert substrate during manufacturing of the product without any additional formulation

steps, the acute toxicity will be the same as that of metofluthrin TGAC. Therefore, for the purposes of this risk

assessment, the acute toxicity of the active constituent (OCS 2009) has been used as a surrogate for the toxicity of

the proposed end-use product.

Based on the findings of the toxicological studies evaluated, the product Off! Clip-on Mosquito Repellent has low

acute oral and dermal toxicity and moderate inhalational toxicity in rats. It is not an eye irritant in rabbits but a slight

skin irritant in the same species, and was not a skin sensitiser in guinea pigs.

The APVMA has considered and accepts the findings and recommendations of the OCS evaluation.

(ii) The APVMA is satisfied that the proposed use of OFF! CLIP-ON MOSQUITO REPELLENT will not be an undue

hazard to the safety of people using anything containing its residues. The product will not be applied to crops or

animals destined for consumption by humans.

(iii) The APVMA is satisfied that the proposed use of OFF! CLIP-ON MOSQUITO REPELLENT containing the active

constituent metofluthrin is not likely to be harmful to human beings if used according to the product label directions.

The product will be used domestically. The most likely route of human exposure to the product is inhalational, with

the possibility of dermal exposure. Further exposure to skin may also occur while changing the refill to the device.

The applicant considers that the duration of exposure of domestic users is the duration of the device’s working life.

Therefore, the product could potentially be used throughout the year.

Exposure data and a risk assessment were provided by the applicant that allowed the daily exposure to be

determined. Exposure to the product during its use was determined to be at an acceptable level. No personal

protective equipment is required during use of the product.



Based on an assessment of the toxicology and occupational health and safety, it was considered that there should

be no adverse effects on human health from the use of Off! Clip-on Mosquito Repellent when used in accordance

with the label directions.

The active constituent has been evaluated and approved and the product is Schedule 6. The appropriate Signal

Heading is on the label. First Aid Instructions and Safety Directions for metofluthrin, as recommended by the OCS

have been included on the label.

(iv) The APVMA is satisfied that the proposed use of OFF! CLIP-ON MOSQUITO REPELLENT is not likely to have an

unintended effect that is harmful to animals, plants or the environment if used according to the product label

directions. The product is designed to be used as a personal insect repellent so little exposure to the environment

is expected.

(v) The APVMA is satisfied that the proposed use of OFF! CLIP-ON MOSQUITO REPELLENT would not adversely

affect trade between Australia and places outside Australia as the product is not for use in crops or animals

producing any major Australian export commodities.

(vi) In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials

supporting the efficacy of the product adequately demonstrate that if used according to the product label directions,

the product is effective for its proposed uses.

MAKING A SUBMISSION

In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written

submission as to whether the application for registration of OFF! CLIP-ON MOSQUITO REPELLENT should be granted.

Submissions should relate only to matters that the APVMA is required by legislation to take into account in deciding

whether to grant the application. These grounds include occupational health and safety, chemistry and manufacture,

residues, safety and first aid, environmental fate and toxicity, trade and efficacy. 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

listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and

in determining appropriate conditions of registration and product labelling.

When making a submission please include:

Contact name

Company or Group name (if relevant)

Email or postal address

The date you made the submission.

All personal and confidential commercial information (CCI)1 material contained in submissions will be treated

confidentially.

Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for

registration should be addressed in writing to:

1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.

http://www.comlaw.gov.au/ComLaw/Legislation/ActCompilation1.nsf/current/bytitle/A06DDA96E680781ECA2573120082EBE6?OpenDocument&mostrecent=1



Pesticides Coordinator

Pesticide Registration

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: (02) 6210 4700

Fax: (02) 6210 4776


mailto:[email protected]


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

OTHER NOTICES

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 (numbered 5P) gazetted on 6th

November 2012 (APVMA 22).

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 1, 2013) 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 http://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. Separate consultations are continuing in response to this 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


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4837

Fax: +61 2 6210 4840


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



Australia New Zealand Food Standards Code —

Standard 1.4.2 — Maximum Residue Limits Amendment Instrument No. APVMA 1, 2013

I, Rajumati Bhula, Program Manager, Pesticides Program 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

Program Manager

Pesticides Program

Dated this eleventh day of January 2013



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 1, 2013.

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 1 of

15th

January 2013.

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 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. 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 20002.

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.

2 Note An amendment history from 20 December 2000 appears at the beginning of the Australia New Zealand Food

Standard 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 –

Glyphosate

Sum of glyphosate and Aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosate

Oilseed [except cotton seed; linseed; rape seed (canola); sunflower seed]

T*0.1

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

Glyphosate

Sum of glyphosate and Aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosate

Oilseed [except cotton seed; peanut; poppy seed; linseed; rape seed (canola); sunflower seed]

T*0.1

Poppy seed T20

Imidacloprid

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

imidacloprid

Blueberries T0.1 Hops, dry T10

Methoxyfenozide

Methoxyfenozide

Almonds T0.2

Spinetoram

Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L

Rape seed (canola) *0.01

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

Glufosinate and Glufosinate-ammonium

Sum of glufosinate-ammonium, N-acetyl glufosinate and 3-[hydroxy(methyl)-phosphinoyl] propionic acid,

expressed as glufosinate (free acid)

Hops, dry T1



Iprodione

Iprodione

Egg plant T1

Spinetoram

Sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L

Milk fats 0.03


Other Notices – Addendum to the Record of Approved Active Constituents

Addendum to the Record of Approved Active Constituents

The current Record of Approved Active Constituents for Registered Chemical Products is also accessible from the

APVMA website, www.apvma.gov.au

APPROVED SINCE GAZETTE NO. 25, 18 DECEMBER 2012

For use in agricultural and/or veterinary chemical products:

Common Name Approval Holder Manufacturer and Site of Manufacture Approval No.

PENFLUFEN BAYER

CROPSCIENCE PTY

LTD

BAYER CROPSCIENCE AG

ALTE HEERSTRASSE

D-41538 DORMAGEN

GERMANY

65142

PICLORAM SHANDONG

RAINBOW

INTERNATIONAL

CO., LTD.

SHANDONG WEIFANG RAINBOW

CHEMICAL CO LTD

1 HAIGANG ROAD, BINHAI ECONOMIC

DEVELOPMENT AREA

WEIFANG, SHANDONG

CHINA

66576

TEBUCONAZOLE SULPHUR MILLS

LIMITED

G.I.D.C. PLOT NO. 1904

A-18/18 PANOLI DIST BHARUCH

STATE GUJARAT

INDIA

67729

NOVALURON UNITED

PHOSPHORUS LTD.

UNITED PHOSPHORUS LIMITED

SURVEY NO 225 GOPIPURA HALOL

GUJARAT 389350

INDIA

67677

IMAZAPYR NUFARM

AUSTRALIA

LIMITED

YANCHENG SOUTH CHEMICALS CO.,

LTD

CHENJIAGANG CHEMICALS DISTRICT

OF XIANGSHUI

YANCHENG CITY 224631

JIANGSU PROVINCE P.R

CHINA

67696

CARFENTRAZONE-

ETHYL

FMC AUSTRALASIA

PTY LTD

FMC CORPORATION

JIANGSU LIANHE CHEMICAL

TECHNOLOGY CO LT

WEISAN ROAD CHENJIAGANG

XIANGSHUI JIANGSU 224631

PR CHINA

68334



Other Notices – Addendum to the Record of Approved Active Constituents

Common Name Approval Holder Manufacturer and Site of Manufacture Approval No.

GLYPHOSATE FOSTERRA PTY

LTD

NANTONG LIHUA AGROCHEMICAL CO.,

LTD.

1 ST ROAD, HUANGHAI

(XIAOYANGKOU, RUDONG COUNTY),

COASTAL ECONOMIC AND

TECHNOLOGICAL

DEVELOPMENT ZONE, RUDONG

CHEMICAL INDUST

PARK, 226407 JIANGSU

PR CHINA

66140

EMAMECTIN

BENZOATE

SINOCHEM

SHANGHAI CO., LTD

17-19/F

NO. 33 HENAN RD. S.,

SHANGHAI, 200002

CHINA

68187

FLUMETSULAM

FARMALINX PTY

LTD

ROBUST FINE CHEMICAL CO., LTD

QING HE INDUSTRIAL ESTATE,

HUA YANG TOWN

CHENGDU, SICHUAN 610213

PR CHINA

67728

DIAFENTHIURON FARMOZ PTY

LIMITED

YANCHENG SOUTH CHEMICALS CO

LTD

CHENJIAGANG CHEMICAL INDUSTRY

DISTRICT

XIANGSHUI COUNTY

YANCHENG CITY, JIANGSU PROVINCE

224631

P.R CHINA

68014

FLUAZINAM PCT HOLDINGS PTY

LTD

YOUTH CHEMICAL CO., LTD

3 DALIAN ROAD,

YANGZHOU CHEMICAL INDUSTRY

ZONE,

YIZHENG, JIANGSU, 211402

PR CHINA

68026

APVMA CONTACT


Application Management & Enquiries


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4701

Fax: +61 2 6210 4721


Other Notices – Application Summaries

Application Summaries

The APVMA publishes complete application summaries on the APVMA website, www.apvma.gov.au. They are

published in weekly instalments using the date the application was accepted for assessment. If an application summary

has been amended, the APVMA will publish the amended version on the website and list it separately in the APVMA

Gazette Notice for Application Summaries.

As a requirement of Regulations 8C and E of the Agvet Code, some product names will appear as 'NOT AVAILABLE'.

A summary will be removed from the website 28 days after the application has been finalised. Therefore, some

summaries published in this notice may have already been removed prior to the Gazette being published.

APPLICATION SUMMARIES PUBLISHED SINCE THOSE PUBLISHED IN APVMA GAZETTE NO.25, 18 DECEMBER

2012

Application No. Name

50096 QUEENSLAND 1080 CONCENTRATE

51427 NOT AVAILABLE

51441 NOT AVAILABLE

51445 NOT AVAILABLE

51447 NOT AVAILABLE

51448 NOT AVAILABLE

56010 CHORULON CHORIONIC GONADOTROPHIN 1500 IU

56011 CHORULON CHORIONIC GONADOTROPHIN 10000 I.U.

56012 CHORULON CHORIONIC GONADOTROPHIN 5000 IU

56767 NOT AVAILABLE

57271 NOT AVAILABLE

57395 NOT AVAILABLE

57792 NOT AVAILABLE

57858 TERMIDOR RESIDUAL TERMITICIDE AND INSECTICIDE

57981 PETS QUALITY AQUARIUM PRODUCTS ALGAE KILLER

58169 CHIPCO ROVRAL GT FUNGICIDE

58217 TRIFLOXYSULFURON SODIUM

58256 SHARP SHOOTER RAPID ACTION WEED KILLER 360 GLYPHOSATE CONCENTRATE

58289 APPARENT BROMOXYNIL + MCPA SELECTIVE HERBICIDE

58327 PRO WET 1000 WETTING AGENT

58328 TRIO WETTA 1000 WETTING AGENT

58357 NOT AVAILABLE

58362 NOT AVAILABLE





58364 NOT AVAILABLE

58376 NOT AVAILABLE

53590 ISK CYAZOFAMID 400 SC FUNGICIDE

55562 FENOXAPROP-P-ETHYL

56708 NOT AVAILABLE

57142 NOT AVAILABLE

57144 NOT AVAILABLE

57145 NOT AVAILABLE

57146 NOT AVAILABLE

57344 PALLADIA 50MG

57345 PALLADIA 15MG

57346 PALLADIA 10MG

57749 RADIAL FUNGICIDE

57919 GHARDA FIPRONIL 800 WG INSECTICIDE

58141 POULVAC LARYNGO A20

58208

PESTXPERT DIY PEST CONTROL LIKE THE PROFESSIONALS PRO-SPRAY FLYING MULTI-

INSECT POWER SPRAY

58209

PESTXPERT DIY PEST CONTROL LIKE THE PROFESSIONALS PRO-SPRAY CRAWLING MULTI-

INSECT CONTACT AND RESIDUAL BARRIER SPRAY

58255 SMART OX 240 HERBICIDE

58261 FIPRONIL

58274 NUFARM CONQUEROR HERBICIDE

58281 WEEDFREE GLYPHOSATE GRANULES HERBICIDE

58286 SUREFIRE TERMITICIDE

58294 RAINBOW GLYPHOSATE 450 HERBICIDE

58350 THIAMETHOXAM

58351 RAID OUTDOOR & SPIDER SURFACE SPRAY

58352 RAID MAX SPIDER KILLER SURFACE SPRAY

58353 RAID MAX ANT KILLER SURFACE SPRAY

58354 RAID INDOOR HOME SURFACE SPRAY

58414 MACPHERSONS CHOPPER 750 SG HERBICIDE

58423 AGMATE GLYPHOSATE 450 SL HERBICIDE

58424 AGMATE 2,4-D 300 SL HERBICIDE




58425 AGMATE TRIFLURALIN 480 EC HERBICIDE

58428 AGMATE PARAQUAT & DIQUAT 250 SL HERBICIDE

58435 PROTECT-US PROFESSIONAL CLEAR GEL COCKROACH BAIT

58462 NOT AVAILABLE

58467 AAKO RIDACIDE 400 EC INSECTICIDE

58475 MEDIFUME NON-FLAMMABLE FUMIGANT

55608 ECLIPSE F ORAL DRENCH FOR CATTLE

56474 OSMOSE MICRONISED TEBUCONAZOLE TIMBER PRESERVATIVE

56609 COUNTRY GLYPHOSATE 600 HERBICIDE

56669 SMART PROPICONAZOLE 250 EC FUNGICIDE

56692 PHD MOTHBALLS

56888 NOT AVAILABLE

57487 BAYCOX COCCIDIOCIDE SOLUTION

57704 VETIMEC IVERMECTIN INJECTION FOR CATTLE

57768 NOT AVAILABLE

57873 LAMBDA CYHALOTHRIN

57876 TOPSHOT ANTIPARASITIC INJECTION FOR CATTLE

57893 SACOX 200 MICROGRANULATE

57927 MAMYZIN ESTER OF BENZYL PENICILLIN FOR INTRAMUSCULAR INJECTION

57975 EUROCHEM DOMICLO 400 WP FUNGICIDE

58052 NOT AVAILABLE

58120

HEARTGARD 30 PLUS (IVERMECTIN/PYRANTEL) CHEWABLES EACH CHEWABLE CONTAINS

272UG IVERMECTIN AND 227MG PYRANTEL (AS EMBONATE SALT)

58121


136UG IVERMECTIN AND 114MG PYRANTEL (AS EMBONATE SALT)

58122


68UG IVERMECTIN & 57MG PYRANTEL (AS EMBONATE SALT)

58130 TOPBAIT GEL COCKROACH BAIT

58132 BRUMBY 480 SC FUNGICIDE

58254 SMART CLOPYRALID 300 HERBICIDE

58260 MACROLONE 20 ANTI-INFLAMMATORY ANTI-ALLERGY

58306 SOLFAC DUO RESIDUAL INSECTICIDE

58326 NOT AVAILABLE




58366 APPARENT GOLD WETTER 1000

58368 THIAMETHOXAM

58369 NOT AVAILABLE

58370 NOT AVAILABLE

58371 NOT AVAILABLE

58372 NOT AVAILABLE

58373 NOT AVAILABLE

58375 NOT AVAILABLE

58377 NOT AVAILABLE

58378 NOT AVAILABLE

58379 NOT AVAILABLE

58380 NOT AVAILABLE

58381 NOT AVAILABLE

58385 TITAN PROPYZAMIDE 500SC HERBICIDE

58398 CONAN 720 FUNGICIDE

58413 MACPHERSONS IMAX 700WDG HERBICIDE

58421 AGRITRADING ORGANOSILICONE SURFACTANT

58422 AGMATE ATRAZINE 900 WG HERBICIDE

58427 AGMATE PROPYZAMIDE 500 SC HERBICIDE

58429 AGMATE 2,4-D 625 SL HERBICIDE

58434 CLEAR WATER ALGAECIDE

58445 OSPRAY RUSTLER SELECTIVE HERBICIDE

58447 NOT AVAILABLE

58460 MASMART CARBENDAZIM SYSTEMIC FUNGICIDE

A change or correction has been made to the following summaries:

Application No. Product/Active Constituent Name

54266 TOUGH ROUNDUP READY TO USE WEEDKILLER

55115 EQUIHEAL STABLE OINTMENT

53830 DUPONT ADVION FIRE ANT BAIT



APVMA CONTACT


Application Management and Enquiries Team (AME)


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4701

Fax: +61 2 6210 4721

Documents

APVMA Gazette no. 1, 15 January 2013