Australian Government No. C 12 Tuesday 4 December 2012 Published by the National Industrial Chemicals Notification and Assessment Scheme - NICNAS Gazette CHEMICAL © Commonwealth of Australia 2012 ISBN 1035-9877 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 Commonwealth available from the Attorney-General’s Department. Requests and inquiries concerning reproduction and rights should be addressed to: Commonwealth Copyright Administration Copyright Law Branch Attorney-General's Department Robert Garran Offices National Circuit Canberra ACT 2600 e-mail: Commonwealth.Copyright@ag.gov.au <mailto:Commonwealth.Copyright@ag.gov.au> web: <http://www.ag.gov.au/cca> The Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) commenced on 17 July 1990. As required by Section 5 of the Act, a Chemical Gazette is published on the first Tuesday in any month or on any days prescribed by the regulations. CONTENTS CONSULTATIONS 1 PG CONSULTATION ON REGULATORY IMPACTS OF A PROPOSAL TO ADOPT THE REVISED AUSTRALIAN AND NEW ZEALAND SUNSCREEN STANDARD (AS/NZS 2604:2012) FOR COSMETIC SUNSCREEN PRODUCTS—CLOSING ON 25 JANUARY 2013 5 SPECIAL NOTICES 2 OFFICE CLOSURE-CHRISTMAS AND NEW YEAR 2012–13 7 3 ACCELERATED ASSESSMENT AND PRIORITISATION OF EXISTING CHEMICALS—STAGE ONE 8 NEW CHEMICALS FULL PUBLIC REPORTS 4 LTD/1616 CHEMICAL IN EUMULGIN L & EUMULGIN HPS LTD/1618 POLYMER IN BETAPRIME 5500 & 5504G LTD/1619 DISPERSANT IN HP DESIGNJET COMMERCIAL AND INDUSTRIAL PRINTER INKS LTD/1622 POLYMER IN DISPERBYK 2091 LTD/1623 POLYMER IN DISPERBYK 2092 STD/1421 ANHYDROXYLITOL STD/1422 XYLITYLGLUCOSIDE PLC/1084 KEIL-FLO 195 PLC/1088 POLYMER IN BYK-415 PLC/1091 POLYMER IN NEOPAC E-122 SAPLC/143 POLYMER IN SCR-500/SCR-500L SAPLC/144 1,4-BENZENEDICARBOXYLIC ACID, 9 POLYMER WITH 1,3-PROPANEDIOL EX/174 5 POLYMER IN SOLSPERSE 76500 ACCESS TO FULL PUBLIC REPORTS 11 PERMITS ISSUED 6 EARLY INTRODUCTION PERMITS 12 7 LOW VOLUME CHEMICAL PERMITS 13 AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES 8 NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES FIVE YEARS AFTER ISSUING OF ASSESSMENT CERTIFICATES 14 9 NOTICE OF CHEMICALS ELIGIBLE FOR IMMEDIATE LISTING ON THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES AFTER ISSUING OF ASSESSMENT CERTIFICATES 16 10 NOTICE OF AMENDMENTS TO THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES 17 11 NOTICE OF AMENDMENTS TO THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES 18 5 1 CONSULTATION ON REGULATORY IMPACTS OF A PROPOSAL TO ADOPT THE REVISED AUSTRALIAN AND NEW ZEALAND SUNSCREEN STANDARD (AS/NZS 2604:2012) FOR COSMETIC SUNSCREEN PRODUCTS— CLOSING ON 25 JANUARY 2013 Purpose NICNAS is consulting on the regulatory impacts on industry, community, and government of the proposed adoption of the revised Australian and New Zealand Sunscreen Standard (AS/NZS 2604:2012 Sunscreen products—Evaluation and classification) in the Cosmetics Standard 2007. If adopted in the Cosmetics Standard 2007, the revised Sunscreen Standard would be applicable to all cosmetic sunscreen products regulated by NICNAS. Background Standards Australia and Standards New Zealand published the revised Sunscreen Standard (AS/NZS 2604:2012) on 30 May 2012. The Cosmetics Standard 2007 currently requires compliance with the old Sunscreen Standard (AS/NZS 2604:1998). The Therapeutic Goods Administration (TGA) amended the Therapeutic Goods Regulation 1990 on 13 November 2012 to recognise the revised Sunscreen Standard. If the revised Sunscreen Standard were adopted by NICNAS, there would be a consistent application of the revised Sunscreen Standard across cosmetic and therapeutic sunscreen products regulated by NICNAS and the TGA, respectively. Proposal The public consultation document is published on the consultation section of the NICNAS website at http://www.nicnas.gov.au/consultation.asp. It is based on the Regulatory Impact Statement (RIS) developed by the TGA in relation to the adoption of the revised Sunscreen Standard for therapeutic sunscreen products, and modified in light of initial comments from industry on its applicability to cosmetic sunscreen products. This approach is based on the similar issues and overlap in manufacturers between the two sectors. However, there is likely to be significant differences between the impact of the revised Sunscreen Standard on cosmetic sunscreen products and therapeutic sunscreen products. Therefore, the consultation document seeks further information on aspects specific to cosmetic sunscreen products. How to express your comments and opinions? A Questionnaire sheet is available on the NICNAS website at http://www.nicnas.gov.au/consultation.asp. Please fill out and send back the Questionnaire sheet. You may attach additional comments if you would like to provide information not addressed in the Questionnaire. If you require further information, please contact Dr Harjit Deol at NICNAS on Tel: 02 85778843; e-mail: harjit.deol@nicnas.gov.au The period for public comments on this consultation will finish at close of business on 25 January 2013. Please submit the Questionnaire addressed to the attention of Dr Harjit Deol: Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012 6 Fax: (02) 8577 8888; e-mail: harjit.deol@nicnas.gov.au, or; Post (no stamp required): Dr Harjit Deol, NICNAS Reply Paid 58 Sydney, NSW 2001 Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012 7 2 OFFICE CLOSURE-CHRISTMAS AND NEW YEAR 2012–13 The NICNAS office will be closed from 3pm Monday 24 December 2012 and re-open on Wednesday 2 January 2013. If you need urgent assistance during this time, please call 0407 228 285. NICNAS staff would like to wish you all a safe and enjoyable holiday season. Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012 8 3 ACCELERATED ASSESSMENT AND PRIORITISATION OF EXISTING CHEMICALS—STAGE ONE As part of the reform regarding assessment of Existing Chemicals, NICNAS is implementing a new framework for the assessment and prioritisation of previously unassessed chemicals that are listed on the Australian Inventory of Chemical Substances (AICS). The new Inventory Multitiered Assessment and Prioritisation (IMAP) Framework is being implemented in a staged manner, with a focus on a subset of chemicals on the AICS meeting characteristics confirmed through stakeholder consultation. This new program will deliver more timely information about the hazards and risks associated with the use of industrial chemicals and identify chemicals which may require risk mitigation to ensure safe use. From July 2012, NICNAS began assessing around 3,000 existing chemicals on AICS using the IMAP Framework (Stage One chemicals). The first tranche of assessments for the Stage One chemicals will be published on the NICNAS website this week. NICNAS is giving interested parties an opportunity to comment on the draft IMAP assessment reports within two months of their initial publication. A guidance document is being published to assist interested parties submitting comments on the IMAP assessment reports. For further information on the new program visit the NICNAS website or contact the Existing Chemicals Program: NICNAS GPO Box 58 Sydney NSW 2001 Tel: 02 8577 8870 e-mail: imap@nicnas.gov.au Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012 9 4 NEW CHEMICALS FULL PUBLIC REPORTS Reference Number Applicant Chemical or Trade Name Hazardous Substance Introduction Volume (per annum) Use LTD/1616 BASF Australia Ltd Yes ≤ 1 tonnes per annum LTD/1618 Dow Chemical Australia Ltd Chemical in Eumulgin L & Eumulgin HPS Polymer in Betaprime 5500 & 5504G Yes <20 tonnes per annum Component of cosmetic products Component of primers for automotive windscreens LTD/1619 Hewlett Dispersant in HP Packard Designjet Australia Pty Lt Commercial and Industrial Printer Inks ND ≤ 0.3 tonnes per annum Component of commercial and industrial printer inks contained in sealed cartridges LTD/1622 Nuplex Industries (Aust) Pty Ltd Polymer in Disperbyk 2091 ND < 30 tonnes per annum Component of industrial coatings and ink The Valspar (Australia) Corporation Pty Ltd STD/1421 Bronson and Jacobs Pty Ltd Anhydroxylitol No 30 tonnes per annum Conditioning agent and humectant for use in cosmetic products, paper and textiles STD/1422 Bronson and Jacobs Pty Ltd Xylitylglucoside No 50 tonnes per annum Conditioning agent and humectant for use in cosmetic products, paper and textiles Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012 10 ≤ 2 tonnes per annum Lubricating oil additive Polymer in BYK- No 415 ≤ 25 tonnes per annum Component of coatings Polymer in NeoPac E-122 No ≤ 50 tonnes per annum A component of floor and industrial coatings Halliburton Australia Pty Ltd Polymer in SCR500/SCR-500L No <0.5 tonnes per annum Component of oil and gas well cements SAPLC/144 DuPont (Australia) Pty Ltd 1,4Benzenedicarbox ylic acid, polymer with 1,3-propanediol No ≤ 5745 tonnes per annum Manufacture of carpets EX/174 Lubrizol International Inc ≤ 10 tonnes per annum Polymeric dispersant at less than 5% in solvent based automotive and industrial paints PLC/1084 Kluber Lubrication Australia Pty Ltd Akzo Nobel Car Refinishes Australia Pty Ltd Nuplex Industries (Aust) Pty Ltd ResChem Technologies Pty Ltd Keil-Flo 195 SAPLC/143 PLC/1088 PLC/1091 Chromaflo Technologies Australia Pty Ltd Polymer in Solsperse 76500 No ND Based on the information available, the notified chemical cannot be classified according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia, or the Approved Criteria for Classifying Hazardous Substances [NOHSC: 1008(2004)] *Select link to view Full Public Report from the NICNAS website Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012 11 5 ACCESS TO FULL PUBLIC REPORT NICNAS publishes a Full Public Report for each new chemical assessed. These reports are available for inspection at our NICNAS office by appointment only at Level 7, 260 Elizabeth Street, SURRY HILLS NSW 2010. Reports can also be viewed and downloaded free of charge from our website at http://www.nicnas.gov.au/. Copies of these reports may also be requested, free of charge, by contacting the Administration Section of NICNAS, Tel: 02 8577 8800 or Fax: 02 8577 8888. Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012 12 6 EARLY INTRODUCTION PERMITS FOR NON-HAZARDOUS INDUSTRIAL CHEMICALS The permits listed in Table 1 were issued to import or manufacture the following chemicals prior to the issue of their respective assessment certificates under section 30A of the Act. Table 1 Early Introduction Permits PERMIT NUMBER COMPANY NAME CHEMICAL OR TRADE NAME 871 Reschem Technologies Pty Ltd 872 Sabic Innovative Lexan CFR Plastics Australia Pty Ltd Component of plastics 873 Bayer MaterialScience Pty Ltd Component of powder coatings Chemical Gazette 2012 Polymer in NeoRez R-9029 USE Crelan EF 403 Component of floor and industrial coatings Commonwealth of Australia Gazette No. C 12, 04 December 2012 13 7 LOW VOLUME CATEGORY PERMITS The permits listed in Table 2 were issued to import or manufacture the following chemicals under section 21U of the Industrial Chemicals (Notification and Assessment) Act 1989. Low Volume Category Permits are approved for 36 months. Table 2 Low Volume Category Permits PERMIT NUMBER COMPANY NAME COMPANY POSTCODE CHEMICAL OR TRADE NAME HAZARDOUS SUBSTANCE USE 983 Merck PtyLtd 3137 RM105 Yes Component of printing ink 984 Merck PtyLtd 3137 RM257 Yes Component of printing ink 987 Lanxess Pty Ltd 2127 Ethanaminium, N,N,N-triethyl-, 1,1,2,2,3,3,4,4,4nonafluoro-1butanesulfonate (1:1) Yes Wetting agent to suppress spray mist in chromium electroplating Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012 14 8 NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES FIVE YEARS AFTER ISSUING OF ASSESSMENT CERTIFICATES Notice is given in accordance with section 14(1) of the Industrial Chemicals (Notification and Assessment) Act 1989, that the following chemicals have been added to the Australian Inventory of Chemical Substances. Table 3 Chemicals Eligible for Listing on the Australian Inventory of Chemical Substances CHEMICAL NAME MOLECULAR FORMULA Neodecanoic acid, ethenyl ester, polymer with N-(1,1-dimethyl-3oxobutyl)-2-propenamide, 2ethylhexyl 2-propenoate and methyl 2-methyl-2-propenoate (C12H22O2.C11H20O2.C9H15NO2. C5H8O2)x CAS NUMBER 1401299-85-1 2-Propenoic acid, 2-methyl-, 2Unspecified hydroxyethyl ester, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, methyl 2-methyl-2propenoate and 2-propenoic acid, bis(1-methyl-1-phenylethyl) peroxideinitiated 1401715-25-0 1,3-Benzenedisulfonic acid, 4-[[2,7dihydro-3-methyl-2,7-dioxo-1-(3sulfobenzoyl)-3H-naphtho[1,2,3de]quinolin-6-yl]amino]-, ammonium salt (1:3) 878651-25-3 C30H20N2O12S3.3H3N Phenol, 4,4'-(1-methylethylidene)bis-, Unspecified polymer with 2-(chloromethyl)oxirane and 1,2-ethanediamine, N(dithiocarboxy) derivs., potassium salts) 1067676-04-3 Thioimidodicarbonic acid ((HO)C(O)NHC(S)(OH)), C,C'dibutyl ester C10H19NO3S 39142-36-4 2-Propenoic acid, 2-methyl-, methyl ester, polymer with butyl 2propenoate and ethenyl acetate (C7H12O2.C5H8O2.C4H6O2)x 30229-42-6 Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012 15 Benzoic acid, 3,5-diamino-2-[2-[2sulfo-4-[2-(4sulfophenyl)diazenyl]phenyl]diazenyl ]-, sodium salt (1:?), reaction products with diazotized 2-[(4aminophenyl)sulfonyl]ethyl hydrogen sulfate, sodium salts Unspecified 298214-91-2 Benzoic acid, 3,5-diamino-2-[2-(1,5disulfo-2-naphthalenyl)diazenyl]-4,6bis[2-[4(ethenylsulfonyl)phenyl]diazenyl]-, sodium salt (1:?) C33H26N8O12S4.xNa 247061-21-8 1,2-Cyclohexanedicarboxylic acid, 1,2-diisononyl ester Fatty acids, linseed-oil, polymers with benzoic acid, iso-Bu methacrylate, methacrylic acid, styrene, sunfloweroil fatty acids, 3a, 4, 7, 7a-tetrahydro1,3-isobenzofurandione and trimethylolpropane, tert-Bu benzenecarboperoxoate-initiated C26H48O4 166412-78-8 Unspecified 916664-96-5 2-Propenoic acid, 2-methyl-, 2hydroxyethyl ester, polymer with butyl 2-propenoate, 2,2-dimethyl-1,3propanediol, ethenylbenzene, 2-ethyl2-(hydroxymethyl)-1,3-propanediol, hexahydro-1,3-isobenzofurandione and 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane, 3,5,5trimethylhexanoate (ester), 12hydroxyoctadecanoic acid-blocked Unspecified 1402597-01-6 2-Propenoic acid, 2-methyl-, polymer with N-(1,1-dimethyl-3-oxobutyl)-2propenamide, ethenylbenzene, 2ethylhexyl 2-propenoate and methyl 2-methyl-2-propenoate (C11H20O2.C9H15NO2.C8H8.C5H8O2. C4H6O2)x 177155-60-1 Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012 16 9 NOTICE OF CHEMICALS ELIGIBLE FOR IMMEDIATE LISTING ON THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES AFTER ISSUING OF ASSESSMENT CERTIFICATES Notice is given in accordance with section 13B of the Industrial Chemicals (Notification and Assessment) Act 1989, that the following chemicals have been added to the Australian Inventory of Chemical Substances. Table 4 Chemicals Eligible for Immediate Listing on the Australian Inventory of Chemical Substances CHEMICAL NAME MOLECULAR FORMULA CAS NUMBER D-Xylitol, 1,4-Anhydro C5H10O4 53448-53-6 D-Glucose, polymer with xylitol (C6H12O6.C5H12O5)x 101469-75-4 Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012 17 10 NOTICE OF AMENDMENTS TO THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES Notice is given, in accordance with subsection 20(b) of the Industrial Chemicals (Notification and Assessment) Act 1989 that the following amendment has been made to the Australian Inventory of Chemical Substances (AICS). Table 5 Amendment to the Australian Inventory of Chemical Substances Based on improved analytical techniques, the original nominator has informed NICNAS that the chemical in the table below, as formulated at the time of nomination, has been found to form a significant part of their product, and thus it has now been added to the AICS. CHEMICAL NAME Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, polymer with 12,12-dimethyl-2,5,8,11,13,16,19,22-octaoxa12-silatricosane Chemical Gazette 2012 CAS NUMBER MOLECULAR FORMULA 86356-30-1 (C16H36O8Si.C6H14O4)x Commonwealth of Australia Gazette No. C 12, 04 December 2012 18 11 NOTICE OF AMENDMENTS TO THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES Notice is given in accordance with section 20AA of the Industrial Chemicals (Notification and Assessment) Act 1989 that, given there were no comments from industry following the publication in the Gazette (Notice 18 in the June 2012) of the Director’s intent to remove 2-decanol, benzoate (CAS RN 31637-00-0) from the Australian Inventory of Chemical Substances (AICS), the chemical has now been removed and benzoic acid, C9-11 branched alkyl esters (CAS RN 131298-44-7) has been added to the AICS. This amendment to the AICS is based on advice from Industry which indicated that CAS RN 31637-00-0 was erroneously nominated instead of CAS RN 131298-44-7. Table 6 Chemical added to the AICS CHEMICAL NAME CAS NUMBER MOLECULAR FORMULA Benzoic acid, C9-11 branched alkyl esters 131298-44-7 Unspecified Chemical Gazette 2012 Commonwealth of Australia Gazette No. C 12, 04 December 2012