07 February 2012

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Australian Government
No. C 02, Tuesday, 7 February 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
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email: 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
CALL FOR SUBMISSIONS ON THE REGULATION IMPACT
STATEMENT FOR CHEMICALS OF SECURITY CONCERN
6
2
REMINDER ABOUT PUBLIC CONSULTATION ON IMPROVING
ACCESS TO INFORMATION TO SUPPORT INTRODUCERS OF
NICNAS ASSESSED CHEMICALS TO NOTIFY THE DIRECTOR
OF CHANGED CIRCUMSTANCES – CLOSING 29 FEBRUARY
2012
7
3
NOTICE REGARDING PROPOSED MINOR AMENDMENT TO
TRANSHIPMENT EXEMPTION PROVISION UNDER THE
INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT)
ACT 1989
9
SPECIAL NOTICES
4
NOTICE OF PROPOSED TRANSFER TO THE AUSTRALIAN
INVENTORY OF CHEMICAL SUBSTANCES OF CERTAIN
COSMETIC INGREDIENTS IN PRODUCTS PREVIOUSLY
REGULATED BY THE THERAPEUTIC GOODS ADMINISTRATION
11
5
NOTICE OF INCLUSION ON THE AUSTRALIAN INVENTORY OF
CHEMICAL SUBSTANCES OF CERTAIN COSMETIC
INGREDIENTS IN PRODUCTS PREVIOUSLY REGULATED BY
THE THERAPEUTIC GOODS ADMINISTRATION
20
6
POST IMPLEMENTATION SURVEY ON IMPACTS OF THE
RESTRICTION OF LEAD COMPOUNDS IN INDUSTRIAL
SURFACE COATINGS AND INKS
26
7
SECONDARY NOTIFICATION OF NOTIFIED CHEMICAL - GTL
DIESEL - STD/1270
27
8
NOTICE REGARDING THE IMPACT OF RECENT CHANGES TO
THE WORK HEALTH AND SAFETY LEGISLATION ON
OBLIGATIONS UNDER THE INDUSTRIAL CHEMICALS
(NOTIFICATION AND ASSESSMENT) ACT 1989
28
NEW CHEMICALS FULL PUBLIC REPORTS
9
LTD/1551
POLYMER IN SYNOLITE 7044-M-1
LTD/1553
ADDITIVE IN COSMONATE T-80
LTD/1557
POLYMER A IN CA1000
LTD/1558
POLYMER B IN CA1000
PLC/1013
Z-116
PLC/1027
POLYMER IN SYNOLAC 1001
STD/1401
CHEMICAL IN PETROSTEP S-2/S-2 HA
STD/1402
CHEMICAL IN PETROSTEP S-3B/S-3B HA
SAPLC/129
POLYMER IN CLEROL PLB 847
LTD/1538
POLYMER IN UVIVID FLEXO JD INK SERIES
SAPLC/128
POLYMER IN DP3000 ENVIRO PRIMER
SURFACER
LTD/1523
POLYMER IN SPECTRALOCK TILE GROUT
LTD/1518
AMPS/ACRYLAMIDE COPOLYMER,
AMMONIUM SALT
PLC/1002
POLYMER IN ACUDYNE DHR
PLC/1028
POLYMER IN AUTOCOAT BT LV 351
PLC/1003
DISPERSANT SK 001
EX/168
POLYMER IN INFINEUM C9290
PLC/1023
POLYMER IN ALKYD RESIN 5056 XX-80
PLC/1024
POLYMER IN ACRYLIC CCBY212 BA-60
31
10
ACCESS TO FULL PUBLIC REPORTS
33
PERMITS ISSUED
11
COMMERCIAL EVALUATION CATEGORY PERMITS
34
12
EARLY INTRODUCTION PERMITS
35
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES
13
NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES FIVE
YEARS AFTER ISSUING OF ASSESSMENT CERTIFICATES
36
14
NOTICE OF CHEMICALS ELIGIBLE FOR IMMEDIATE LISTING ON
THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES
AFTER ISSUING OF ASSESSMENT CERTIFICATES
38
1
CALL FOR SUBMISSIONS ON THE REGULATION IMPACT
STATEMENT FOR CHEMICALS OF SECURITY CONCERN
The Attorney-General’s Department (AGD) invites submissions on the Regulation
Impact Statement (RIS) on precursor chemicals to homemade explosives. The RIS
analyses a number of options to treat the security risks posed by precursor chemicals to
homemade explosives. AGD is seeking input from the general public and industry on
several key issues, including the perceived effectiveness of the proposed measures and
their respective costs to industry.
AGD is particularly interested in receiving input from businesses that manufacture,
handle or use any products that contain the following chemicals:
 Hydrogen peroxide (H2O2)
 Ammonium perchlorate (NH4ClO4)
 Sodium chlorate (NaClO3)
 Sodium nitrate (NaNO3)
 Nitric acid (HNO3)
 Potassium nitrate (KNO3)
 Potassium chlorate (KClO3)
 Nitromethane (CH3NO2)
 Sodium perchlorate (NaClO4)
 Sodium azide (NaN3)
 Potassium perchlorate (KClO4)
To access a copy of the Consultation RIS and to find out how to make a submission,
please refer to the AGD Chemical Security program website at
www.chemicalsecurity.gov.au/RIS.
For further information you can also contact AGD on (02) 6141 2925 or (02) 6141 3012.
The public consultation period will commence on Friday 3 February and end on Friday
30 March 2012.
7
2
REMINDER ABOUT PUBLIC CONSULTATION ON IMPROVING
ACCESS TO INFORMATION TO SUPPORT INTRODUCERS OF NICNAS
ASSESSED CHEMICALS TO NOTIFY THE DIRECTOR OF CHANGED
CIRCUMSTANCES – CLOSING 29 FEBRUARY 2012
Purpose
To remind stakeholders that NICNAS is seeking public comment on a proposal to
provide introducers of NICNAS assessed chemicals with improved access to information
that will help fulfill obligations to notify the Director of NICNAS when a significant
change in circumstances occurs relative to the original assessment. The initial
announcement of the public consultation was in the Chemical Gazette of 1 November
2011. Stakeholders are reminded that comments should be submitted by 29 February
2012.
Background
The Industrial Chemicals (Notification and Assessment Act) 1989 (the Act) specifies
circumstances in which secondary notification of a previously assessed chemical may be
required. However, a high proportion of assessment reports for new chemicals published
on the NICNAS web site do not contain the identity of the assessed chemical. For
chemicals where the record on the Australian Inventory of Chemical Substances (AICS)
contains the chemical name and number and indicates that the chemical has been
assessed, it is often difficult to know the circumstances of that assessment. Therefore, it is
difficult for introducers of previously assessed chemicals to fulfill their obligations under
the Act.
Proposal
NICNAS is proposing to provide information on the AICS records of previously assessed
chemicals to aid potential introducers in fulfilling their obligations under the Act by
improving access to information about the original chemical assessment with regard to
secondary notification. This public consultation document is published on the
consultation section of the NICNAS website at
http://www.nicnas.gov.au/Consultations.asp and on the Australian Government Business
website at https://consultation.business.gov.au/consultation.
The NICNAS web page provides more information on the submission process.
Submissions
Written submissions can be provided to:
Dr Bill Diver
Reform Section
NICNAS
Phone 02 8577 8862
Fax: 02 8577 8888
e-mail: bill.diver@nicnas.gov.au
Submissions should be received by 29 February 2012.
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Please note that all submissions will be published on the NICNAS website. If you wish to
have material exempt from publication, you must provide a reason for claiming
confidentiality and clearly mark any confidential material contained within your
submission.
Chemical Gazette
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No. C 02, 07 February 2012
9
3
NOTICE REGARDING PROPOSED MINOR AMENDMENT TO
TRANSHIPMENT EXEMPTION PROVISION UNDER THE INDUSTRIAL
CHEMICALS (NOTIFICATION AND ASSESSMENT) ACT 1989
Purpose
NICNAS seeks views by COB Friday 2 March 2012 on a proposed amendment to the
wording of the transhipment exemption provision (Sn 21(6)(b)) of the Industrial
Chemicals (Notification and Assessment) Act 1989 (the Act) to better reflect transhipment
of industrial chemicals through Australia.
Background
Section 21 of the Act provides for a number of exemptions to the requirement for the
notification and assessment of new industrial chemicals, that is, chemicals not already
listed on the Australian Inventory of Chemical Substances. One of these exemptions
addresses new chemicals that will be transported to a third country via Australia, but will
not be used or released in Australia.
This transhipment exemption was introduced into the Act in 2004 on the basis of a
recommendation arising from consultations on the NICNAS Low Regulatory Concern
Chemicals (LRCC) Initiative in 2003. The relevant recommendation was to “introduce a
Transhipment Exemption for instances when chemicals are offloaded at an Australian
port of entry and remain in containment unopened for a short period (30 days) before
reshipment out of Australia.”
The legislative provision at Sn21(6)(b) was drafted to state that the chemical “remains
subject to the control of Customs … at the port or airport [of introduction] at all times
before leaving Australia”(see Table 1 for a full reproduction of Sn 21(6)(b)).
A further consultation as part of a 2009 evaluation of the impact of the implementation
of recommendations from the 2004 LRCC Initiative lead to the proposal that the
transhipment exemption “be extended to include custom-bonded warehouses”. The
rationale was that the transhipment exemption has extremely low uptake by industry and
that “larger companies who have need of such an exemption often prefer to keep goods in
their own custom-bonded warehouses”.
Proposal
To address the proposal from the 2009 evaluation, NICNAS proposes to remove a
reference in Sn21(6)(b)(ii) to “at the port or airport” in regard to where the chemicals
must be sited when remaining under the control of Customs (see Table 2 for the full,
amended provision),. This amendment is intended to provide an exemption to the
notification and assessment of a new chemical when the chemical remains under Customs
control in a slightly broader range of situations.
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Table 1 – current wording of Sn 21(6)(b) under the Act
21(6)(b) a new industrial chemical:
(i)
that is introduced by a person at a port or airport in Australia; and
(ii)
that remains subject to the control of Customs (within the meaning of
the Customs Act 1901) at the port or airport at all times before leaving
Australia; and
(iii) that leaves Australia less than 30 days after the day of introduction
Table 2 – proposed wording of Sn 21(6)(b) under the Act (redacted words highlighted
by strike through)
21(6)(b) a new industrial chemical:
(i)
that is introduced by a person at a port or airport in Australia; and
(ii)
that remains subject to the control of Customs (within the meaning of
the Customs Act 1901) at the port or airport at all times before leaving
Australia; and
(iii) that leaves Australia less than 30 days after the day of introduction
NICNAS seeks views as to whether the proposed adjustment to the wording of
Sn21(6)(b) correctly describes how chemicals are transhipped and are maintained under
the control of Customs.
Please provide comments by COB Friday 2 March 2012 by:



email to Dr Matthew Gredley, Head of Reform Program, NICNAS
(matthew.gredley@nicnas.gov.au);
fax to 02 8777 8888 (marked ATTN: Matt Gredley);
mail to GPO Box 58, Sydney, NSW 2001 (marked ATTN Matt Gredley).
Chemical Gazette
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No. C 02, 07 February 2012
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4
NOTICE OF PROPOSED TRANSFER TO THE AUSTRALIAN
INVENTORY OF CHEMICAL SUBSTANCES OF CERTAIN COSMETIC
INGREDIENTS IN PRODUCTS PREVIOUSLY REGULATED BY THE
THERAPEUTIC GOODS ADMINISTRATION
In accordance with sections 15AA(1) and 15AA(2) of the Industrial Chemicals
(Notification and Assessment) Act 1989 (the Act) the Director proposes to include the
chemicals listed in Table 1 in the public section of the Australian Inventory of Chemical
Substances (AICS) for cosmetic use only, along with certain conditions of use. These
chemicals are currently regulated by NICNAS as new chemicals. Comments on this
proposal should be made by close of business (5.30 pm) 6 March 2012.
Background
The regulatory responsibility for chemicals in certain cosmetic products that were
previously regulated by the Therapeutic Goods Administration (TGA) was transferred to
NICNAS under the cosmetic reforms in 2007. As a result of the transfer, those chemicals
not already on the AICS were recognised as new industrial chemicals and therefore
required notification and assessment as new chemicals before being imported or
manufactured, and/or are subject to post market reporting.
The intent of the cosmetic reform was that the transfer of responsibility would occur
whilst maintaining health and safety standards and without posing unnecessary burden on
industry. Therefore, it was envisioned that those chemicals not already on the AICS
would be recognised as existing industrial chemicals by listing them on the public AICS
subject to controls that are not less stringent than those previously required by the TGA.
A mechanism to list certain chemicals on the public section of the AICS that were
previously regulated by another Commonwealth regulator came into force on 27
September 2011. This occurred following modification of the Act by the Industrial
Chemicals (Notification and Assessment) Amendment (Inventory) Bill 2011. NICNAS
published a notice in the October 2011 Chemical Gazette detailing the resulting changes
to the Act and how NICNAS will be implementing those changes.
Requirements for proposing to list chemicals on the AICS
In order to be considered by the Director, NICNAS for possible transfer onto the AICS
under the cosmetic reforms, chemicals need to meet two sets of criteria.
The first set of criteria is legislated under Section 15AA of the Act, and applies to any
group of chemicals proposed by the Director, NICNAS for listing on the AICS as a result
of regulatory reform. These criteria are:



the chemical was previously regulated by another Commonwealth regulator, or
was in a product regulated by another Commonwealth regulator; and
there is no NICNAS assessment certificate in force for the chemical; and
the chemical is currently in use in Australia.
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In addition, consideration must be given as to whether the chemical poses an
unreasonable risk to occupational health and safety, public health or the environment.
The second set of criteria is specific to the particular circumstances of the cosmetic
reforms. These criteria are:
 the chemical was an ingredient in at least one of the products that were regulated
under TGA; and
 the product(s) meets the definition of a cosmetic under the Act and any
requirements in the Cosmetic Standard 2007; and
 the product(s) was in commerce at some time during the three-year period
preceding the cosmetic reforms, that is, September 2004 to September 2007; and
 the chemical is not currently listed on the AICS.
NICNAS has been actively considering 62 chemicals or substances for possible listing on
the AICS. Previously 61 chemicals were under consideration but one chemical, which
was notified for assessment, has been added to the list as the notifier indicated an
intention to withdraw the notification pending the outcome of the listing process.
In the Chemical Gazette of 1 November 2011, the Director, NICNAS, proposed the
listing of an initial group of 34 chemicals for use in cosmetic products together with
proposed controls.
Three chemicals are still being considered and advice will be provided shortly.
This notice proposes the listing of a further group of 25 chemicals for use in cosmetic
products and in accordance with the proposed conditions of use.
Proposal
In accordance with sections 15AA(1) and 15AA(2) of the Act, the Director proposes to
include the 25 chemicals and associated conditions of use listed in Table 1 in the public
section of the AICS for cosmetic use only, or a subset of cosmetic products.
Section 15AA(5)(e) requires the Director, NICNAS, to state the reasons why these
chemicals are proposed for listing on the AICS. These reasons are:



listing these chemicals on the AICS fulfils the intent of the cosmetic reforms to
recognise certain chemicals in cosmetic products previously regulated by the
TGA as industrial chemicals whilst maintaining health and safety standards and
without posing unnecessary burden on industry;
the chemicals fulfil the eligibility criteria specific to the cosmetics reforms and
legislated criteria for listing as described in Section 15AA(1);
although these chemicals have not been subject to a full assessment by NICNAS,
the Director considers that, when used in cosmetic products only and in
accordance with the proposed conditions of use, these chemicals do not pose an
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unreasonable risk to occupational health and safety, public health and the
environment.
In determining that these chemicals pose no unreasonable risk when used within the
proposed conditions of use, the Director noted that some of the chemicals possessed
certain properties that may pose a risk to human health and/or the environment when used
outside of the proposed conditions of use. The chemicals in Table 1 can be considered in
4 groups:




Group 1: 14 chemicals for which existing TGA controls are adequate when
applied to any cosmetic product.
Group 2: 6 chemicals which may pose an unreasonable risk to the
environment only. The additional control specified is to restrict these
chemicals to the product class in which they were nominated so that the risk is
mitigated to being reasonable. In all cases this is a secondary sunscreen with
an SPF up to 15.
Group 3: 4 chemicals which may pose an unreasonable risk to both health and
the environment. The additional condition of use specified is to restrict these
chemicals to the product class in which they were nominated. In all cases this
is a secondary sunscreen with an SPF up to 15.
Group 4: 1 chemical which may pose an unreasonable risk to health. The
additional control is to restrict the concentration in any cosmetic product to
5%.
This notice is published in the Chemical Gazette in accordance with section 15AA(4) of
the Act.
Statements about the Proposal
For any of the chemicals listed in Table 1, in accordance with section 15AA(5)(g) of the
Act, a person may give a statement to the Director, within 28 days of the date of
publication of this notice, giving reasons why the person objects to the Director’s
proposal.
Persons who wish to make a statement in relation to this proposal should do so in writing
by close of business (5.30pm) Tuesday 6 March 20121. The statement should address
specific chemicals (ie not be a generic statement) and provide relevant argument relating
to the stated reasons given in this notice as to why the Director, NICNAS, is proposing to
list the chemical on the AICS.
Statements should be provided to the contact officer detailed below.
Next Steps
1
The Acts Interpretation Act 1901 requires that a time period commences with day 1 being the day after
the publication of a notice. Therefore 28 days from publication of this notice is 6 March 2012.
Chemical Gazette
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14
In accordance with section 15AA(7) of the Act, once the 28 days have passed, the
Director will, having regard to any statements received, make a final decision to include
or not include any chemical and associated conditions of use on the AICS for which a
statement has been received.
Under section 15AA(8), the Director will then publish a notice in the Chemical Gazette
listing any final decisions that have been made. An application can be made to the
Administrative Appeals Tribunal (AAT) for a review of a final decision by the Director.
Given the close of comments is COB 6 March 2012, the earliest opportunity to publish
the notice will be the April 2012 Chemical Gazette.
Under Section 15AB, after at least 28 days has passed since the publication of the
Director’s decision and an application to the AAT has not been made, or with regard to
the finalisation of any appeal that has been made to the AAT, the Director must include
the chemical in the AICS, along with any conditions of use, and give notice of this action
in the Chemical Gazette.
Following these processes, the relevant chemical will be regarded as an existing chemical
within the context of the conditions of use, and so can be introduced into Australia
without pre market notification or post market reporting to NICNAS if it is used in
accordance with the conditions of use. Under Section 15A of the Act, failure to comply
with these conditions of use is an offence, and will require the chemical to be notified to
NICNAS as a new industrial chemical, unless an exemption applies.
Introduction of a chemical for such other uses (for example, for a non-cosmetic use; or
for a cosmetic use but at a higher concentration than specified in the condition of use)
would mean the chemical is a new chemical as defined under Section 5 of the Act. The
introduction of such a new chemical is subject to Section 21 of the Act and the associated
requirements prescribed in the Industrial Chemicals (Notification and Assessment)
Regulations 1990.
Arrangements for annually reporting of chemicals proposed for listing on the AICS
The chemicals in Table 1 proposed for transfer to the AICS under section 15AA of the
Act are currently considered new chemicals and so are subject to the premarket
notification and assessment requirements and/or post market reporting obligations under
Part 3 Division 1 of the Act. These reporting obligations currently apply for these
chemicals, however if the chemicals are ultimately transferred to the AICS, annual
reports will no longer be required if used in cosmetic products under the specified
conditions of use.
In order to reduce the impact of the uncertainty on business about the annual reporting
arrangements for 2011-12 while the chemicals are being proposed for transfer to the
AICS, the Director, NICNAS, has decided not to seek reports under s21AA for the
chemicals in Table 1 that are introduced as new chemicals for use in cosmetics within the
Chemical Gazette
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15
specified conditions of use during the current registration year between 1 September 2011
and 31 August 2012.
Further information on annual reporting arrangements are outlined in a notice in the
November 2011 Chemical Gazette:
http://www.nicnas.gov.au/Publications/Chemical_Gazette/Chemical_Gazette_November
_2011/Notice_6.asp.
If you require further information please contact:
Dr Bill Diver
Reform Section
NICNAS
Phone 02 8577 8862
Fax: 02 8577 8888
email: bill.diver@nicnas.gov.au
GPO Box 58
Sydney
NSW 2110
Chemical Gazette
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Table 1 Chemicals proposed for inclusion in the public section of the Australian Inventory of Chemical Substances under Sections
15AA(1) and 15AA(2) of the Industrial Chemicals (Notification and Assessment) Act 1989
Group 1 Chemicals for which existing controls are adequate
INCI name/AAN
CAS name
Acetyl Carnitine HCL (AAN:
Acetyllevocarnitine
hydrochloride)
1-Propanaminium, 2(acetyloxy)-3-carboxyN,N,N-trimethyl-, chloride,
(2R)Laminaria, ext.
Algae Extract
Butyrospermum Parkii (Shea)
Butter Unsaponifiables
CAS
No.
508050-2
Fats and Glyceridic oils, shea
butter, unsaponifiable
fraction
L-Glutamic acid, N-(1oxododecyl)-, mixed
(3.beta.)-cholest-5-en-3-yl
Cholesteryl/behenyl/octyldodecyl and docosyl and octyldodecyl
lauroyl glutamate
esters
Ethylbisiminomethylguaiacol
Manganese, chloro[[2,2'manganese chloride
[1,2-ethanediylbis[(nitrilo.kappa.N)methylidyne]]bis[6methoxyphenolato.kappa.O]](2-)]-, (SP-5-13)Lauryl laurate
Micrococcus lysate (AAN
Micrococcus luteus lysate)
Chemical Gazette
Dodecanoic acid, dodecyl
ester
Micrococcus luteus, lysate
Conditions of Use
For Cosmetic Use Only.
92128- For Cosmetic Use Only.
82-0
225234- For Cosmetic Use Only.
14-0
For Cosmetic Use Only. For dermal
use only. The concentration is not to
exceed 0.5%. It is not to be included in
244023- topical products intended for use in the
78-7
eye.
81065- For Cosmetic Use Only. For dermal
76-1
use only. The concentration is not to
exceed 0.002%. It is not to be included
in topical products intended for use in
the eye.
13945- For Cosmetic Use Only.
76-1
158765- For Cosmetic Use Only. For dermal
79-8
use only. The concentration is not to
exceed 0.002% and is not intended for
Commonwealth of Australia Gazette
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17
use in the eye.
Octyldodecyl Neopentanoate*
Palmitoyl
hydroxypropyltrimonium
amylopectin/glycerin
crosspolymer
Propanoic acid, 2,2-dimethyl, 2-octyldodecyl ester
Waxes and Waxy substances,
orange roughy
Amylopectin, 2-hydroxy-3(trimethylammonio)propyl
ether, polymer with 1,2,3propanetriol, hexadecanoate
15856766-9
9107899-8
52885560-9
Phospholipids
Phospholipids
123465- For dermal use only. The
35-0
concentration is not to exceed 20%
and is not to be used in topical
products intended for use in the eye.
Polyquaternium-51
3,5,8-Trioxa-4phosphaundec-10-en-1aminium, 4-hydroxyN,N,N,10-tetramethyl-9-oxo, inner salt, 4-oxide, polymer
with butyl 2-methyl-2propenoate
Sanguisorba officinalis, ext.
125275- For Cosmetic Use Only. For dermal
25-4
use only. The concentration is not to
exceed 5% and is not to be used in
topical products intended for use in the
eye.
8478771-3
For Cosmetic Use Only.
Glycoproteins, bovine-whey
8408251-9
For Cosmetic Use Only.
Orange roughy oil
Sanguisorba Officinalis Root
Extract (TGA name: Poterium
officinale)
Whey Protein
Chemical Gazette
none
For Cosmetic Use Only.
For Cosmetic Use Only. For dermal
use only. The concentration is not to
exceed 0.01% and is not to be used in
topical products intended for use in the
eye.
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Group 2: Chemicals which may pose an unreasonable risk to the environment.
INCI name/AAN
CAS name
Diethylamino Hydroxybenzoyl Hexyl
Benzoate (Uvinul A Plus)
Benzoic acid, 2-[4(diethylamino)-2hydroxybenzoyl]-,
hexyl ester
Hexanoic acid, 2ethyl-, 1,1'-(2,2dimethyl-1,3propanediyl) ester
Neopentyl Glycol Diethylhexanoate
Propylene Glycol Myristyl Ether
Acetate
CAS
No.
30277668-7
2851023-8
Propanol,
(tetradecyloxy)-,
acetate
Trihydroxypalmitamidohydroxypropyl Hexadecanamide,
Myristyl Ether
9,10,16-trihydroxy-N[2-hydroxy-3(tetradecyloxy)propyl]-
13532654-4
Bertholletia Excelsa Extract
16096504-8
Chemical Gazette
Brazil nut, ext.
13127637-4
Conditions of Use
For Cosmetic Use Only. For use in
topical (dermal) sunscreen products
with an SPF up to 15 only. The
concentration is not to exceed 10%.
For Cosmetic Use Only. To be used
only as an ingredient in topical
sunscreen product s with an SPF up to
15. The concentration of this
ingredient in the final product should
be 5% or less. It should not be used in
topical preparations intended for the
eye.
For Cosmetic Use Only. For use only
in sunscreen products with an SPF up
to 15.
For Cosmetic Use Only. For dermal
use only. For use only in sunscreen
products with an SPF up to 15. The
concentration is not to exceed 0.02%
and is not to be used in topical
products intended for use in the eye.
For Cosmetic Use Only. For use only
in sunscreen products with an SPF up
to 15.
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Potentilla erecta root extract
Potentilla erecta, ext.
9008309-3
For Cosmetic Use Only. For use only
in sunscreen products with an SPF up
to 15.
Group 3: Chemicals (plant extracts) which may pose an unreasonable risk to health and the environment.
INCI name/AAN
Aspalathus linearis Extract
CAS name
Aspalathus linearis, ext.
CAS No.
776295-36-4
Boswellia serrata extract
Salai, ext.
97952-72-2
Poria Cocos Sclerotium
Extract (TGA name: Poria
cocos)
Scutellaria Baicalensis
Extract/Root Extract
Poria cocos, ext.
168456-53-9
Scutellaria baicalensis,
ext.
94279-99-9
Conditions of Use
For Cosmetic Use Only. For use only
in sunscreen products with an SPF up
to 15.
For Cosmetic Use Only. For use only
in sunscreen products with an SPF up
to 15.
For Cosmetic Use Only. For use only
in sunscreen products with an SPF up
to 15.
For Cosmetic Use Only. For use only
in sunscreen products with an SPF up
to 15.
Group 4: Chemical which may pose an unreasonable risk to health.
INCI name/AAN
Cetearyl octanoate
Chemical Gazette
CAS name
Hexanoic acid, 2-ethyl-,
C16-18-alkyl esters
CAS No.
90411-680
Conditions of Use
For Cosmetic Use Only. The
concentration is not to exceed 5%.
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
20
5
NOTICE OF INCLUSION ON THE AUSTRALIAN INVENTORY OF
CHEMICAL SUBSTANCES OF CERTAIN COSMETIC INGREDIENTS IN
PRODUCTS PREVIOUSLY REGULATED BY THE THERAPEUTIC GOODS
ADMINISTRATION
In accordance with Subsection 15AB(2) of the Industrial Chemicals (Notification and
Assessment) Act 1989 (the Act), this notice is to advise that the Director, NICNAS, has
included on the public section of the Australian Inventory of Chemical Substances (AICS) 34
chemicals for cosmetic use only, along with associated conditions of use (see Table 1).
Background
The regulatory responsibility for chemicals in certain cosmetic products that were previously
regulated by the Therapeutic Goods Administration (TGA) was transferred to NICNAS under
the cosmetic reforms in 2007.
The Director, NICNAS proposed, via a notice published in the Chemical Gazette of 1
November 2011, an initial list of 34 chemicals for transfer to the AICS, along with associated
conditions of use in accordance with subsections 15AA(1) and 15AA(2) of the Act.
The Decision
No statements objecting to the proposal for transfer to the AICS of any of the 34 chemicals
were received within the 28 day time limit. Therefore, the Director, NICNAS decided to
include each of these chemicals in the public section of the AICS for cosmetic use only,
together with an associated conditions of use.
Notice of this decision was given in the Chemical Gazette of 6 December 2011. Included in
this notice was advice that, under subsection 15AB(1) of the Act, each decision to include a
chemical on the AICS was subject to appeal to the Administrative Appeals Tribunal (AAT).
No applications for review of the decision were received.
Inclusion of Chemicals on the AICS
Under Section 15AB, after at least 28 days has passed since the publication of the Director’s
decision and if an application to the AAT has not been made, or with regard to the
finalisation of any appeal that has been made to the AAT, the Director must include the
chemical in the public section of the AICS, along with any conditions of use, and give notice
of this action in the Chemical Gazette.
Notice is hereby given that each of the chemicals listed in Table 1 have been placed on the
non-confidential section of the AICS for cosmetic use only within the listed conditions of
use.
Chemical Gazette
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
21
Consequence of inclusion on the AICS
Status as an existing chemical when introduced within condition of use
Under subsection 11(4) of the Act, each chemical listed in Table 1 is regarded as an existing
chemical within the context of the conditions of use, and so the chemical may only be
imported or manufactured as an existing chemical if the importation or manufacture is in
accordance with the condition of use included on the AICS. Failure to comply with these
conditions of use when introducing as an existing chemical is an offence under Section 15A
of the Act.
These chemicals are now no longer subject to new chemical annual reporting requirements
under Section 21AA when used in cosmetics and within the specified conditions of use.
Status as a new chemical when introduced outside condition of use
Introduction of the chemicals listed in Table 1 for uses other than those specified (for
example, for a non-cosmetic use; or for a cosmetic use but at a higher concentration than
specified in the condition of use) results in the chemical being considered a new chemical as
defined under Section 5 of the Act. The introduction of such a new chemical is subject to
Section 21 of the Act and the associated requirements prescribed in the Industrial Chemicals
(Notification and Assessment) Regulations 1990.
Note that in determining that the chemicals listed in Table 1 pose no unreasonable risk when
used within the conditions of use listed on the AICS, the Director has noted that various of
the chemicals possess certain properties that may pose a risk to human health or the
environment when used outside of these conditions.
If you require further information please contact:
Dr Bill Diver
Reform Section
NICNAS
Phone 02 8577 8862
Fax: 02 8577 8888
email: bill.diver@nicnas.gov.au
GPO Box 58
Sydney
NSW 2110
Chemical Gazette
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
22
Table 1 Chemicals included in the public section of the Australian Inventory of Chemical Substances under Sections 15AB(2) of the
Industrial Chemicals (Notification and Assessment) Act 1989
INCI name/AAN
Acetyl
trifluoromethylphenyl
valylglycine
Aminopropyl Ascorbyl
Phosphate
Arginine ferulate
Ascorbyl
Tetraisopalmitate (AAN:
Tetrahexyldecyl
ascorbate)
Ascorbyl Tocopheryl
Maleate
Benzylidene camphor
sulfonic acid
Butylene glycol
dicaprylate/dicaprate
Chemical Gazette
CAS name
Glycine, N-Acetyl-N-[3(trifluoromethyl)phenyl]valyl-
CAS No.
379685-96-8
L-Ascorbic acid, 2-(3aminopropyl hydrogen phosphate)
(9CI)
L-Arginine, 3-(4-hydroxy-3methoxyphenyl)-2-propenoate
(1:1)
L-Ascorbic acid, tetrakis(2hexyldecanoate)
220644-17-7
L-Ascorbic acid, 2-[(2R)-3,4dihydro-2,5,7,8-tetramethyl-2[(4R,8R)-4,8,12trimethyltridecyl]-2H-1benzopyran-6-yl (2Z)-2butenedioate], compd. with 1propanol (1:1) (9CI)
Benzenesulfonic acid, 4-[(4,7,7trimethyl-3oxobicyclo[2.2.1]hept-2ylidene)methyl]Decanoic acid, mixed diesters
with 1,2-butanediol and octanoic
acid
488109-67-7
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.0575%. It is not to be included in topical products intended for
use in the eye.
56039-58-8
For Cosmetic Use Only. For dermal use only. The concentration of this
ingredient as an active sunscreen ingredient is 6% (as acid).
686341-29-7
For Cosmetic Use Only. To be used an excipient ingredient in dermal
products only. The concentration is not to exceed 10% and this ingredient
is not intended for use in the eye.
950890-74-1*
183476-82-6
Conditions of Use
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.5%. It is not to be included in topical products intended for use
in the eye.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.1%. It is not to be included in topical products intended for use
in the eye.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.05% and is not to be used in topical products intended for use in
the eye.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 1%. It is not to be included in topical products intended for use in
the eye.
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
23
C10-30
Cholesterol/Lanosterol
Lanolin ester
Ceramide 1
Ceramide 2
Ceramide 3
Decarboxy Carnosine HCl
Dipotassium glycyrrhizate
Disodium Phenyl
Dibenzimidazole
Tetrasulfonate
Disteardimonium hectorite
Erythrulose
Chemical Gazette
Fatty acids, C10-30, esters with
lanolin alcs.
97862-72-1
For Cosmetic Use Only.
9,12-Octadecadienoic acid
(9Z,12Z)-, 30-[[(1S,2R,3E)-2hydroxy-1-(hydroxymethyl)-3heptadecen-1-yl]amino]-30oxotriacontyl ester
Octadecanamide, N-[(1S,2R)-2hydroxy-1(hydroxymethyl)heptadecyl]Octadecanamide, N[(1S,2S,3R)-2,3-dihydroxy-1(hydroxymethyl)heptadecyl]Propanamide, 3-amino-N-[2(1H-imidazol-5-yl)ethyl]-,
hydrochloride (1:2)
α-D-Glucopyranosiduronic acid,
(3β,20β)-20-carboxy-11-oxo30-norolean-12-en-3-yl-2-O-βD-glucopyranuronosyl-,
potassium salt (1:2)
1H-Benzimidazole-4,6disulfonic acid, 2,2’-(1,4phenylene)bis-, disodium salt
Quaternary ammonium
compounds, di-C16-18alkyldimethyl, salts with
hectorite
2-Butanone, 1,3,4-trihydroxy
156170-27-3
For Cosmetic Use Only.
2304-80-5
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.05%. It is not to be included in topical products intended for use
in the eye.
For Cosmetic Use Only.
34354-88-6
57022-38-5
68797-35-3
180898-37-7
94891-31-3
40031-31-0
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.05%. It is not to be included in topical products intended for use
in the eye.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.2%. It is not to be included in topical products intended for use
in the eye.
For Cosmetic Use Only. Approved as an active ingredient (UV filter) for
use in sunscreen preparations. The concentration level is not to exceed
10% in the final finished product.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 2%. It is not to be included in topical products intended for use in
the eye.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 2%. It is not to be included in topical products intended for use in
the eye. There was no data submitted examining the effect of Erythrulose
on the eye, which does not allow for an assessment of its potential ocular
irritancy.
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
24
Glucosylrutin
4H-1-Benzopyran-4-one, 3-[(O6-deoxy-.alpha.-Lmannopyranosyl-(1.fwdarw.6)O-[.alpha.-D-glucopyranosyl(1.fwdarw.4)]-.beta.-Dglucopyranosyl)oxy]-2-(3,4dihydroxyphenyl)-5,7dihydroxy2-Propenoic acid,
homopolymer, ester with 1,2,3propanetriol
Poly(oxy-1,2-ethanediyl),
.alpha.-hydro-.omega.-hydroxy, ether with methyl .beta.-dglucopyranoside (4:1)
L-Lysine, N-(1oxohexadecyl)glycyl-L-histidylL-Serine, N2-(1-oxohexadecyl)L-lysyl-L-threonyl-L-threonylL-lysyl1,3,4-Octadecanetriol, 2-amino, (2S, 3S, 4R)-
130603-71-3
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.1%. It is not to be included in topical products intended for use
in the eye.
104365-75-5
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.15%. It is not to be included in topical products intended for use
in the eye.
For Cosmetic Use Only.
Polyglyceryl-3
methylglucose distearate
alpha-D-glycopyranoside,
methyl, monoether with
triglycerol, dioctadecanoate
157175-98-9
PPG-20 Methyl Glucose
Ether
Poly[oxy(methyl-1,2ethanediyl)], .alpha.-hydro.omega.-hydroxy-, ether with
methyl .beta.-d-glucopyranoside
(4:1)
Retinol, 15-[(9Z,12Z)-9,12octadecadienoate]
61849-72-7
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.5% and is not to be used in topical products intended for use in
the eye.
631-89-0
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.1% and is not to be used in topical products intended for use in
the eye.
Glyceryl polyacrylate
Methyl gluceth-20
Palmitoyl oligopeptide
Palmitoyl Pentapeptide-4
(was called Palmitoyl
Pentapeptide-3)
Phytosphingosine
Retinyl Linoleate
Chemical Gazette
68239-42-9
147732-56-7
214047-00-4
554-62-1
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.002% and is not intended for use in the eye.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.0005% and is not intended for use in the eye.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.1% and is not to be used in topical products intended for use in
the eye.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 6.0% and is not to be used in topical products intended for use in
the eye.
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
25
Sodium carbomer
Sodium Carboxymethyl
Betaglucan
Sodium Carboxymethyl
Dextran
Sodium DNA
Carbomer, sodium salt
.beta.-D-Glucan, (1.fwdarw.3)-,
carboxymethyl ether, sodium
salt
Dextran, carboxymethyl ether,
sodium salt
DNA, sodium complexes
Sodium Lauroyl Lactylate
73298-57-4
9050-93-5
39422-83-8
438545-06-3
Dodecanoic acid, 2-(1carboxyethoxy)-1-methyl-2oxoethyl ester, sodium salt
Sodium stearoyl glutamate
L-Glutamic acid, N-(1oxooctadecyl)-, monosodium
salt
Tetrahydrodiferuloylmethane 3,5-Heptanedione, 1,7-bis(4hydroxy-3-methoxyphenyl)-
13557-75-0
Tridecyl salicylate
Benzoic acid, 2-hydroxy-,
tridecyl ester
19666-16-1
Trioctyldodecyl citrate
1,2,3-Propanetricarboxylic acid,
2-hydroxy-, 1,2,3-tris(2octyldodecyl) ester
126121-35-5
Chemical Gazette
38517-23-6
36062-04-1
For Cosmetic Use Only.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.005% and is not to be used in topical products intended for use
in the eye.
For Cosmetic Use Only.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.1% and is not to be used in topical products intended for use in
the eye.
For Cosmetic Use Only.
For Cosmetic Use Only. Approved for dermal use only as an excipient
ingredient. The concentration is not to exceed 2.5% in the finished
product and is not be used in topical preparations intended for the eye.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 0.1% and is not to be used in topical products intended for use in
the eye.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 5% and is not to be used in topical products intended for use in
the eye.
For Cosmetic Use Only. For dermal use only. The concentration is not to
exceed 12% and is not to be used in topical products intended for use in
the eye.
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
26
6
POST IMPLEMENTATION SURVEY ON IMPACTS OF THE RESTRICTION
OF LEAD COMPOUNDS IN INDUSTRIAL SURFACE COATINGS AND INKS
This notice is directed to persons who



Import or manufacture industrial surface coatings and/or inks.
Import or manufacture components of industrial surface coatings and/or inks.
Use industrial surface coatings and/or ink products/components.
NICNAS is conducting a review of the impact on industry, workers and the public of
restricting the concentration of lead in industrial surface coatings and inks. We are seeking to
collect data by way of a voluntary, web based survey which will run until Friday 27 April
2012. The restrictions have now been fully implemented since January 2009 and the Office of
Best Practice Regulation (OBPR) requires this review to be undertaken post implementation,
as a Regulatory Impact Statement was not completed prior to introduction of the restrictions.
The review will consider impacts across industry, the public and the not for profit sector and
will consider not only financial, but health and safety impacts as well.
In September 2007, NICNAS published its assessment report on the health effects of certain
lead compounds used in industrial surface coatings and inks
http://www.nicnas.gov.au/Publications/CAR/PEC/PEC29.asp ). The report recommended that
the Australian Inventory of Chemical Substances (AICS) be annotated to restrict the
concentration of lead to 0.1% or less. The Director of NICNAS accepted the recommendation
and annotated the AICS, in accordance with S13 of the Industrial Chemicals (Notification
and Assessment) Act (1989), via a phased approach to minimise the impact on business.
Industrial surface coatings, which include liquid products and powder coatings, are those not
typically used in domestic situations. For example, painting of factories, bridges, motor
vehicles, machinery and equipment, and coating of materials used in commercial buildings
such as window frames. Restrictions on lead compounds in inks relate not only to industrial
uses, but to any uses of inks.
The survey can be completed and submitted online and is available on the NICNAS website
at http://www.nicnas.gov.au/Consultations.asp.
For further information contact Stephen Zaluzny on 02 8577 8883, or if outside the 02 STD
area freecall 1800 638 528, or by e-mail at Stephen.zaluzny@nicnas.gov.au
Chemical Gazette
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
27
7
SECONDARY NOTIFICATION OF NOTIFIED CHEMICAL
GTL DIESEL
STD/1270
Under subsection 65(2) of the Industrial Chemical (Notification and Assessment) Act 1989
(the Act), the Director requires the secondary notification of GTL Diesel by:
The Shell Company of Australia Limited
8 Redfern Road
Hawthorn East
Melbourne, VIC 3123
The data required are as follows:
Any changes in the following data items from that submitted in the original notification:
a) proposed uses and concentrations of the chemical;
b) import quantity (and transportation and packaging);
c) operation description;
d) occupational, public and environmental exposure associated with the proposed uses
(including introduction, reformulation, use, recovery and disposal);
e) physico-chemical properties; and
f) any additional toxicity or ecotoxicity data that is available.
The required information or alternatively, a timetable for the provision of the requested
information, should be provided to the Director within 28 days of the publication of this
notice.
Chemical Gazette
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
28
8
NOTICE REGARDING THE IMPACT OF RECENT CHANGES TO THE
WORK HEALTH AND SAFETY LEGISLATION ON OBLIGATIONS UNDER THE
INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT) ACT 1989
Purpose
To advise of the impact of recent changes to the Work Health and Safety Legislation on
hazard classification of new and existing chemicals by NICNAS.
Background
Work Health and Safety Legislation
New work health and safety laws commenced in New South Wales, Queensland, the
Australian Capital Territory, the Commonwealth and the Northern Territory on 1 January
2012. These new laws are based on the Model Work Health and Safety legislation developed
by Safe Work Australia. More information on the model legislation, as well as the progress of
other jurisdictions to implementing the new laws, can be found at
http://www.safeworkaustralia.gov.au/Legislation/Pages/ModelWHSLegislation.aspx
Under the new legislation the hazard classification of chemicals will be conducted in
accordance with the Globally Harmonised System of Classification and Labelling of
Chemicals (GHS), as adopted in the Model Work Health and Safety Regulations2. A 5 year
transition period will apply in which classifications under the Approved Criteria for
Classifying Hazardous Substances [NOHSC: 1008(2004)] will be acceptable in addition to
the GHS.
Issues
Implications for classifying new chemicals
From 1 January 2012 all new chemicals will be assessed primarily against the criteria for
classification under the GHS as adopted in the Model Work Health and Safety Regulations
and appropriate recommendations made for classification to the introducer and provided to
Safe Work Australia. Recommendations for classifications under the Approved Criteria for
Classifying Hazardous Substances will continue to be provided during the 5 year transition
period. As is the current practice, new chemicals assessments will include environmental
GHS classifications for information purposes.
Hazard criteria for assessment of new chemicals
If only GHS information is available to the introducer, NICNAS will consider a chemical as a
hazardous chemical if it satisfies the criteria for a hazard class in the GHS (3rd edition),
except where that chemical satisfies the criteria solely for one of the following hazard classes:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
acute toxicity – oral- category 5;
acute toxicity – dermal – category 5;
acute toxicity – inhalation – category 5;
skin corrosion/irritation – category 3;
serious eye damage/eye irritation – category 2B;
aspiration hazard – category 2;
flammable gas – category 2;
acute hazard to the aquatic environment – category 1, 2 or 3;
2
Information on the Model Work Health and Safety Regulations can be found at:
http://www.safeworkaustralia.gov.au/Legislation/AdministrativeRegulations/Pages/Model%20work%20health%
20and%20safety%20Regulations.aspx.
Chemical Gazette
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
29
(i) chronic hazard to the aquatic environment – category 1, 2, 3 or 4;
(j) hazardous to the ozone layer.
Note: This definition of a hazardous chemical is consistent with that set out in the Model
Work Health and Safety Regulations.
For some new chemical permit categories, the hazard eligibility criteria are associated with
specific risk phrases. In these instances, the equivalent GHS classes that are outlined in Table
1 will apply.
Table 1: New Chemical Permit Categories Hazard Criteria
Hazard
Irritating to skin
Irritating to eyes
Risk Phrase under
Approved Criteria
R38
R36
carcinogenic effects
R40, R45, R49
mutagenic effects
R46
reproductive effects
R60-64
very toxic and toxic acute
lethal effects
corrosive effects
R23-28
sensitising effects
R42, R43
non-lethal irreversible
effects after a single
exposure
R39, R68
severe effects after
repeated or prolonged
exposure
R48
Chemical Gazette
R34, R35, R41
Hazard class in the GHS
Skin irritation – category 2
Eye irritation – category
2A
Carcinogen - category 1A,
1B or 2
Germ cell mutagen category 1A or 1B
Reproductive toxicant –
category 1A, 1B or 2; or
Effects on or via lactation
Acute toxicity – category
1, 2 or 3
Skin corrosion – category
1A , 1B or 1C; or Eye
damage – category 1
Respiratory sensitiser –
category 1A or 1B; or Skin
sensitiser – category 1A or
1B
Specific target organ
toxicity single – category 1
or 2; or Germ cell mutagen
– category 2
Specific target organ
toxicity repeat – category
1 or 2
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
30
Implications for existing chemicals
Assessments of existing chemicals will continue to include recommendations under both the
GHS, as adopted in the Model Work Health and Safety Regulations, and Approved Criteria
for Classifying Hazardous Substances until the end of the 5 year transition period.
If you require further information please contact:
Dr Sarah Rumble
New Chemicals Assessment Program
sarah.rumble@nicnas.gov.au
Chemical Gazette
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
31
9
NEW CHEMICALS FULL PUBLIC REPORTS
Table 1
New Chemical Full Public Report
Reference
Number
Applicant
Chemical or Trade
Name
Hazardous
Substance
Introduction
Volume (per
annum)
Use
LTD/1551
Karpelo
Holdings Pty
Ltd
Polymer in Synolite
7044-M-1
ND*
≤ 3 tonnes per
annum
A component of
automobile putties
LTD/1553
Mitsubishi
Australia Ltd
Additive in
Cosmonate T-80
ND*
≤ 1 tonne per
annum
A component of
polyurethane foam
LTD/1557
PPG
Industries
Australia Pty
Ltd
PPG
Industries
Australia Pty
Ltd
Lubrizol
International
Inc.
PPG
Industries
Australia Pty
Ltd
Nalco
Australia Pty
Ltd
Polymer A in
CA1000
ND*
≤ 1 tonnes per
annum
Component of sealants
Polymer B in
CA1000
ND*
≤ 3 tonnes per
annum
Component of sealants
Z-116
No
≤300 tonnes per
annum
Component of engine
oils
Polymer in Synolac
1001
No
< 1 tonne per
annum
Component of coatings
Chemical in
PETROSTEP S-2/S2 HA
Yes
≤ 1,500 tonnes per
annum
STD/1402
Nalco
Australia Pty
Ltd
Chemical in
PETROSTEP S3B/S-3B HA
Yes
≤ 1,500 tonnes per
annum
A component in a
surfactant blend for use
in enhanced oil
recovery operations
A component in a
surfactant blend for use
in enhanced oil
recovery operations
SAPLC/129
BASF
Australia Ltd
Polymer in Clerol
PLB 847
No
? 10 tonnes per
annum
LTD/1538
FUJIFILM
Australia Pty
Ltd
Polymer in UVIVID
FLEXO JD Ink
Series
ND*
≤ 5000 tonnes per
annum
Component of
plasterboard jointing
products
Component of ink for
flexographic printing
SAPLC/128
PPG
Industries
Australia Pty
Ltd
Laticrete Pty
Ltd
Polymer in DP3000
Enviro Primer
Surfacer
No
< 3 tonnes per
annum
Component of coating
for automobiles
Polymer in
SpectraLOCK Tile
Grout
AMPS/acrylamide
copolymer,
ammonium salt
Yes
< 1 tonne per
annum
ND*
≤30 tonnes per
annum
Ingredient in a three
part tile grout system at
< 2.5%.
cement applications in
the oil and gas industry
LTD/1558
PLC/1013
PLC/1027
STD/1401
LTD/1523
LTD/1518
Schlumberger
Australia Pty
Ltd
Chemical Gazette
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
32
PLC/1002
PLC/1002
PLC/1002
PLC/1028
Rohm & Haas
Australia Pty.
Ltd.
Dow
Chemicals
Australia Ltd
Capitol
Ingredients
Aust Pty Ltd
Akzo Nobel
Car Refinishes
PLC/1003
3M Australia
Pty Ltd
PLC/1003
International
Sales &
Marketing Pty
Ltd
Australasian
Lubricants
Manufacturing
Company Pty
Ltd
Akzo Nobel
Car Refinishes
EX/168
PLC/1023
PLC/1024
Akzo Nobel
Car Refinishes
Polymer in Acudyne
DHR
No
≤30 tonnes per
annum
Component of
hairstyling products
Polymer in Autocoat
BT LV 351
No
≤ 20 tonnes per
annum
Surface Coatings
Dispersant SK 001
No
No
≤ 20 tonnes per
annum
Component of printing
inks and coatings
Polymer in Infineum
C9290
No
≤ 50 tonnes per
annum
Lubricant component in
engine oil
Polymer in Alkyd
Resin 5056 XX-80
No
≤ 20 tonnes per
annum
Surface Coatings
Polymer in Acrylic
CCBY212 BA-60
No
≤ 20 tonnes per
annum
Surface Coatings
N.D.: not determined; insufficient data available to effect a health effects classification under Approved Criteria
[NOHSC:1008(2004)]
*Select link to view Full Public Report from the NICNAS website
Chemical Gazette
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
33
10
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 260 Elizabeth
St 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 by phone: (02) 8577 8800 or fax:
(02) 8577 8888.
Chemical Gazette
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
34
11
COMMERCIAL EVALUATION CATEGORY PERMIT
The permits listed in Table 2 were issued to import or manufacture the following chemicals
for commercial evaluation under section 21G of the Industrial Chemicals (Notification and
Assessment) Act 1989.
Table 2
Commercial Evaluation Category Permits
PERMIT
COMPANY
COMPANY
CHEMICAL
HAZARDOUS
NUMBER
NAME
POSTCODE
OR TRADE
SUBSTANCE
QUANTITY
USE
PERIOD
APPROVED
NAME
786
Toyota Tsusho
(Australasia) Pty
Ltd
3026
KAOLIZER
P200
ND
4000
Catalyst for
use in
production of
polyurethane
6 Jan 2012
to 6 Jan
2014
N.D.: not determined; insufficient data available to effect a health effects classification under
Approved Criteria [NOHSC:1008(1999)]
Chemical Gazette
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
35
12
EARLY INTRODUCTION PERMITS FOR NON-HAZARDOUS INDUSTRIAL
CHEMICALS
The permits listed in Table 3 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 3
Early Introduction Permits
PERMIT
NUMBER
793
794
795
796
797
798
799
800
801
804
Chemical Gazette
COMPANY
NAME
CHEMICAL OR
TRADE NAME
DSM Nutritional
Products
Australia Pty Ltd
Rohm & Haas
Australia Pty Ltd
Dow Chemical
(Australia) Pty
Ltd
DuluxGroup
(Australia) Pty
Ltd
International
Sales &
Marketing Pty
Ltd
Chemiplas
Australia Pty Ltd
Polymer in Tilamar Fix A140
Component of haircare products
Polymer in Acusol 420N
Component of dishwashing and laundry
products
Component of dishwashing and laundry
products
Amtrade
International Pty
Ltd
DuPont
(Australia) Ltd
Evonik Australia
Pty Ltd
All Raw
Materials Pty Ltd
Polymer in Acusol 420N
USE
Vestagon EP-BF 1321
Used in industrial metal coatings
Vestagon EP-BF 1321
Used in industrial metal coatings
Polymer in Basoplast PX
7305 X ap / Basoplast 8903
ap
Polymer in VECTRA E
9501RX
Component in the manufacture of paper
Component in plastic cookware
Fluorinated Chemical in
TLF10620
Polymer in Viscoplex 6/6887
Surfactant for use in water-based surface
coatings at ≤0.1%.
Lubricating additive for engine oils
UNI-REZ 138
Component of printing inks
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
36
13
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 4
Chemicals Eligible for Listing on the Australian Inventory of Chemical Substances
CHEMICAL NAME
Boron, trifluoro(tetrahydrofuran)-, (T-4)-,
polymer with alpha-hydro-omegahydroxypoly(oxy-1,2-ethanediyl) and 3methyl-3-[(2,2,3,3,3pentafluoropropoxy)methyl]oxetane
Boron, trifluoro (tetrahydrofuran)-, (T-4)-,
polymer with 2-methyloxirane, 3-methyl-3[(2,2,3,3,3pentafluoropropoxy)methyl]oxetane, oxirane
and tetrahydrofuran
Phosphonic acid, P-octadecyl-, monomethyl
ester
Oxirane, methyl-, polymer with oxirane,
mono(3,5,5-trimethylhexyl) ether
Cuprate (3-), [2-[[[[3-amino-2-(hydroxy.kappa.O]-5-sulfophenyl]azo.kappa.N2]phenylmethyl]azo-kappaN1]-4sulfobenzoato (5-)-.kappa.O]-trisodium,
reaction products with 2-[[2-[(4,6-difluoro1,3,5-triazin-2yl)phenylamino]ethyl]sulfonyl]ethyl
hydrogen sulfate
2,5-Cyclohexadien-1-one, 2,6-bis(1,1dimethylethyl)-4-(phenylmethylene)Acetamide, 2-hydroxy-, N,N-dicoco alkyl
derivs.
Ethanol, 2,2'-sulfonylbis2,5-Furandione, polymer with .alpha.-[4(ethenyloxy)butyl]-.omega.hydroxypoly(oxy-1,2-ethanediyl), sodium
salt
Phosphorodithioic acid, O,O-bis(1,3dimethylbutyl) S-(2-hydroxypropyl) ester,
phosphate, compd. with 2-ethyl-1hexanamine
Chemical Gazette
MOLECULAR
FORMULA
CAS NUMBER
(C8H11F5O2.C4H8BF3O.(C2
H4O)nH2O)x
753501-43-8
(C8H11F5O2.C4H8BF3O.C4H
8O.C3H6O.C2H4O)x
864910-70-3
C19H41O3P
25371-55-5
C9H20O.(C3H6O.C2H4O)x
204336-40-3
Unspecified
898565-48-5
C21H26O
7078-98-0
Unspecified
866259-61-2
C4H10O4S
2580-77-0
(C4H2O3.(C2H4O)n.C6H12O2)
250591-55-0
x.xNa
C15H33O3PS2.xC8H19N.xH3
O4P
1345023-51-9
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
37
Poly[oxy(methyl-1-2-ethanediyl)], .alpha.-(1oxotetradecyl)-.omega.-(phenylmethoxy)-
Chemical Gazette
(C3H6O)nC21H34O2
642443-86-5
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
38
14
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 5
Chemicals Eligible for Immediate Listing on the Australian Inventory of Chemical
Substances
CHEMICAL NAME
Fatty acids, C18-unsatd., dimers,
hydrogenated, polymers with
ethylenediamine and stearyl alc.
Chemical Gazette
MOLECULAR FORMULA
Unspecified
CAS
NUMBER
951153-32-5
Commonwealth of Australia Gazette
No. C 02, 07 February 2012
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