04 December 2012

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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
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