Australian Government
No. C 04 Tuesday, 02 April 2013
Published by the National Industrial Chemicals
Notification and Assessment Scheme - NICNAS
Gazette
CHEMICAL
© Commonwealth of Australia 2013
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
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and inquiries concerning reproduction and rights should be addressed to:
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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
CONSULTATION OUTCOMES
1
SUMMARY OF OUTCOMES FROM NICNAS
CONSULTATION ON PROPOSAL TO ADOPT THE
REVISED AUSTRALIAN/NEW ZEALAND SUNSCREEN
STANDARD (AS/NZS 2604:2012 SUNSCREEN
PRODUCTS – EVALUATION AND CLASSIFICATION)
FOR COSMETIC SUNSCREEN PRODUCTS
PG
5
SPECIAL NOTICES – NICNAS
2
NOTICE OF DECISION TO INCLUDE ON THE
AUSTRALIAN INVENTORY OF CHEMICAL
SUBSTANCES CERTAIN COSMETIC INGREDIENTS IN
PRODUCTS PREVIOUSLY REGULATED BY THE
THERAPEUTIC GOODS ADMINISTRATION
6
3
NOTICE OF DECISION TO NOT INCLUDE ON THE
AUSTRALIAN INVENTORY OF CHEMICAL
SUBSTANCES CERTAIN COSMETIC INGREDIENTS IN
PRODUCTS PREVIOUSLY REGULATED BY THE
THERAPEUTIC GOODS ADMINISTRATION
14
SPECIAL NOTICE – OFFICE OF CHEMICAL SAFETY
4
REVIEW OF ARRANGEMENTS FOR SCHEDULING
SUBSTANCES
22
NEW CHEMICALS FULL PUBLIC REPORTS
5
LTD/1544
WALNUT ESTER
LTD/1604 POLYMER IN SUNCURE STARLUXE &
SUNCURE LAZER INKS
LTD/1645 1,2,3-PROPANETRIOL, HOMOPOLYMER,
ETHER WITH METHYL DGLUCOPYRANOSIDE
DIOCTADECANOATE (INCI NAME:
POLYGLYCERYL-3 METHYLGLUCOSE
DISTEARATE)
23
STD/1400 CHEMICAL IN AEROSHELL ASCENDER
STD/1416 OC-1600 CROSSLINKING AGENT
STD/1430 DISTEARYL ETHER
STD/1445 CHEMICAL IN HITEC 4898C FUEL
ADDITIVE
PLC/1111 NEJI-34
EX/177 POLYMER IN SYNOLITE 7044-M-1
6ACCESS TO FULL PUBLIC REPORTS
25
PERMITS ISSUED
7
EARLY INTRODUCTION PERMITS
26
8
LOW VOLUME CHEMICAL PERMITS
27
9
CONTROLLED USE PERMITS
28
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES
10
NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON
THE AUSTRALIAN INVENTORY OF CHEMICAL
SUBSTANCES FIVE YEARS AFTER ISSUING OF
ASSESSMENT CERTIFICATES
29
11
NOTICE OF CHEMICALS ELIGIBLE FOR IMMEDIATE
LISTING ON THE AUSTRALIAN INVENTORY OF
CHEMICAL SUBSTANCES AFTER ISSUING OF
ASSESSMENT CERTIFICATES
32
5
1
SUMMARY OF OUTCOMES FROM NICNAS CONSULTATION ON
PROPOSAL TO ADOPT THE REVISED AUSTRALIAN/NEW ZEALAND
SUNSCREEN STANDARD (AS/NZS 2604:2012 SUNSCREEN PRODUCTS –
EVALUATION AND CLASSIFICATION) FOR COSMETIC SUNSCREEN
PRODUCTS
Purpose
To inform interested parties on the outcomes of the NICNAS consultation on a proposal
to adopt the revised Australian/New Zealand Sunscreen Standard (AS/NZS 2604:2012
Sunscreen products – Evaluation and classification) for cosmetic sunscreen products.
This consultation opened on 4 December 2012 and closed on 25 January 2013.
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
Regulations 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.
The purpose of this consultation was to assess any regulatory impacts on businesses,
community, and government of a proposal by NICNAS to adopt the revised Australian
and New Zealand Sunscreen Standard (AS/NZS 2604:2012) in the Cosmetics Standard
2007.
A notice advertising the consultation was published in the Chemical Gazette of 4
December 2012, on the Australian Government Business website, and also on the
Australian Government public consultation website. A reminder notice was also
published in the Chemical Gazette of 2 January 2013.
A total of fourteen responses were received, with thirteen from industry (including three
industry associations) and one from a community association. A summary analysis of
results is published on the Consultations section of the NICNAS website at
http://www.nicnas.gov.au/Consultations/Proposal_To_Adopt_Sunscreen_Standard.asp.
Next steps
As required by the Government’s best practice regulatory requirements, NICNAS is
drafting a Regulatory Impact Statement to inform any Government decision on this
matter.
Enquiries
For more information please contact Dr Bin Fang on (02) 8577 8825 or e-mail
bin.fang@nicnas.gov.au
Chemical Gazette 2013
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No. C 01, 02 January 2013
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2
NOTICE OF DECISION TO INCLUDE ON THE AUSTRALIAN
INVENTORY OF CHEMICAL SUBSTANCES CERTAIN COSMETIC
INGREDIENTS IN PRODUCTS PREVIOUSLY REGULATED BY THE
THERAPEUTIC GOODS ADMINISTRATION
In accordance with Section 15AA(8) of the Industrial Chemicals (Notification and
Assessment) Act 1989 (the Act), this notice gives the final decision of the Director,
NICNAS, to include on the public section of the Australian Inventory of Chemical
Substances (AICS) one chemical 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 intent of the reforms is that the
transfer of responsibility would occur whilst maintaining health and safety standards and
without posing unnecessary burden on industry.
As a result of this transfer, the chemicals in these cosmetic products that were not
already on the AICS became new industrial chemicals, and therefore required
notification and assessment unless exemptions applied. A mechanism to list certain
chemicals on the AICS as existing chemicals came into force on 27 September 2011
with amendments to the Act.
In order to be considered by the Director, NICNAS, for placement on the AICS, these
chemicals needed to meet two sets of criteria: a generic set under the amended
legislation; and a second set specific to the cosmetic reforms. To ascertain which
chemicals were to be considered for transfer, NICNAS undertook a call for information
in the February 2010 Chemical Gazette. As a result of clarifying identity information
and applying the eligibility criteria, the Director, NICNAS identified 62 chemicals or
substances for possible listing on the AICS. In addition, the Director, NICNAS must
consider whether these chemicals pose an unreasonable risk to occupational health and
safety, public health or the environment.
The proposal for listing
This chemical was proposed for listing on the AICS via Notice 9 in the Chemical
Gazette of 5 June 2012.
In this Notice the Director, NICNAS stated reasons why this chemical was proposed for
listing on the AICS in accordance with section 15AA(5)(e) of the Act. Briefly, these
reasons were that:



listing this chemical on the AICS fulfils the intent of the 2007 cosmetic reforms;
the chemical fulfilled eligibility criteria; and
the Director considers that the chemical does not pose an unreasonable risk to
occupational health and safety, public health and the environment, when used in
accordance with the proposed conditions of use.
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Statements on the proposal were due within 28 days of the notice, by 3 July 2012.
Stakeholder response to the proposal for listing the chemical
One statement was received in regard to the chemical within the 28 day period specified
under section 15AA(5)(g) of the Act. The Director, NICNAS, proposed conditions of
use for the chemical, noting that the chemical possessed certain properties that may pose
a risk to human health and/or the environment when used outside of the proposed
conditions of use. Whilst the submission supported the listing of the chemical on the
AICS, the submission objected to the proposed condition of use on the basis that:
 the submitter did not accept that certain components of the extract have possible
endocrine disrupting activity and oestrogen receptor binding effects in addition
to other biological effects.
 NICNAS did not present any sound scientific evidence that the ingredient poses
an unreasonable risk to public health and/or the environment;
 NICNAS has no power to make risk management decisions in regard to the
chemical;
 the NICNAS restrictions are inconsistent with the use of these chemicals
internationally;
 as this proposal will have a significant detrimental impact on the commercial
operations of many companies and the supply of product into the market place,
an impact assessment is required; and
 the introduction of unique Australian requirements in the absence of any sound
scientific evidence will provide a barrier to trade and could lead to challenges
through the World Trade Organisation.
The statement included an alternative proposed condition of use within which any
unreasonable risk was proposed to be mitigated. This is shown in Table 1.
The Director’s consideration of statements received
General considerations
In relation to the statement provided above by the submitter:


the Director noted in the proposal notice 9 of June 2012 that “the chemical
possessed certain properties that may pose a risk to human health and/or the
environment when used outside of the proposed conditions of use”. This
observation was informed by the application of a hazard screening process
involving Quantitative Structure Activity Relationship (QSAR) modelling and a
review of literature; and
the new legislative mechanism provides the power for the Director to annotate
the AICS with conditions of use under Section 15AA(2).
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Considerations regarding unreasonable risk
Section 15AA (3) requires the Director to consider whether the use of the chemical
poses an unreasonable risk to occupational health and safety, public health or the
environment.
The Director considered that the submitter did not provide any data to conclude that this
chemical does not pose an unreasonable risk to human health and the environment
within the conditions of use proposed by submitter. As a result, the Director decided on
the basis of the available information that the original view about the unreasonable risk
which may be posed by this chemical remains unchanged, and therefore appropriate
conditions of use to mitigate this risk should be maintained.
The Decision
The Director therefore makes the following decision regarding the listing of the
chemical in table 1 on the public AICS in accordance with section 15AA(7). Moreover,
the table is prefaced with a statement concerning how the Director took account of the
statement received.
For ease of reference, Table 1 contains:



the CAS number and INCI name/AAN in the first column;
the original conditions of use proposed by the Director in the June 2012 notice,
the conditions proposed in the stakeholder submission along with the final
conditions of use decided by the Director in the second column; and
the reasons for decision, including a summary of the scientific evidence that the
ingredient poses an unreasonable risk to public health and/or the environment, in
the third column.
Your right to apply for a review of this Decision
Under Section 15AB(1) of the Act, for each decision to include a chemical listed in
Tables 1 and 2 on the AICS, a period of at least 28 days is allowed for persons to apply
to the Administrative Appeals Tribunal (AAT) for a review of that decision.
Information concerning the right to apply to the AAT and the means of doing so is
included in an attachment to this notice. In particular, you must apply to the AAT
within 28 days of the date of this notice.
Next Steps
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. Pending any application for
review to the AAT, NICNAS expects these processes to occur on 7 May 2013 at the
earliest.
Chemical Gazette 2013
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No. C 01, 02 January 2013
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If listed on the AICS, the chemical will be regarded as an existing chemical within the
context of the conditions of use, and so can be introduced into Australia without premarket 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.
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) would mean the chemical remains as 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.
In order to reduce the impact of the uncertainty on business about annual reporting
arrangements, in the proposal of June 2012, the Director, NICNAS advised that reports
would not be sought for this chemical during the registration year between 1 September
2011 and 31 August 2012. The Director has decided to continue this arrangement for
this chemical during the current registration year between 1 September 2012 and
31 August 2013.
Hence the Director will not seek reports under s21AA for the chemical in Table 1 that is
introduced as a new chemical for cosmetic use within the specified conditions of use
while the chemical is in the process of proposed transfer to the AICS.
If you require further information please contact Dr Bin Fang, bin.fang@nicnas.gov.au
Reform Section, NICNAS
GPO Box 58
Sydney, NSW 2001s
Freecall: 1800 638 528
Phone: 02 8577 8825
Fax: 02 8577 8888
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
10
Table 1: Chemical decided for inclusion in the public section of the Australian Inventory of Chemical Substances under Section 15AA(7) of the
Industrial Chemicals (Notification and Assessment) Act 1989
The following chemical was proposed for listing with a condition of use. One statement was received and it proposed a removal of the
concentration limit. No data were provided to support the submission that the chemicals do not pose an unreasonable risk to human safety and
the environment if appropriate conditions of use to mitigate this risk are not maintained. Therefore a change to the proposed condition of use is
not considered warranted, and the decision is to maintain the conditions proposed.
CAS No.
INCI
name/AAN
1174920-93-4
Morus Bombycis
Root Extract
Conditions of Use:
1. As originally proposed
2. As proposed in statement received
3. Conditions of use decided
1. For Cosmetic Use Only. The concentration
in products is not to exceed 0.015%.
2. For Cosmetic Use Only.
3. For Cosmetic Use Only. The concentration
in products is not to exceed 0.015%.
Reasons for Decision
Three identified components of the chemical (Albafuran A,
Albanin A and Mulberrofuran H) were profiled in the OECD
QSAR Tool box for oestrogen receptor binding as ‘very strong
binder, OH group’. This prediction is on the basis that the
chemicals have a molecular weight > 200 and < 500 and contain
two non-impaired OH groups attached to two different 5 to 6 Catom rings.
Oestrogen receptor binding is a molecular initiating event that
leads to a series of adverse outcomes, which are typically
considered reproductive and development hazards. No relevant
in vitro and in vivo assay data as per the OECD conceptual
framework for testing and assessment of endocrine disrupting
chemicals have been identified. No national or international risk
assessments for the chemical have been identified.
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In the absence of further information, there is uncertainty about
the potential impact on human health and the environment. The
uncertainty in these effects on human health or the environment
may be mitigated at low concentrations, as similar chemicals are
commonly found in food at low levels.
The chemical is reported to have biological effects (inhibition of
melanin production) (Maeda 1996; Hwang 2007). As a result, the
concentration that can be used in cosmetic products would be
limited. The proposed concentration condition is close to the
concentrations known to be currently in use in Australia.
References
Hwang JH, Lee BM (2007) Inhibitory Effects of Plant Extracts on Tyrosinase, l-DOPA Oxidation, and Melanin Synthesis. Journal of
Toxicology and Environmental Health, Part A, 70(5), 393-407.
Maeda K and Fukuda M (1996) Arbutin: mechanism of its depigmenting action in human melanocyte culture. Journal of Pharmacology and
Experimental Therapeutics, 276 (2), 765-769.
OECD conceptual framework for testing and assessment of endocrine disrupting chemicals accessed at
http://www.oecd.org/env/ehs/testing/OECD%20Conceptual%20Framework%20for%20Testing%20and%20Assessment%20of%20Endocrine%2
0Disrupters%20for%20the%20public%20website.pdf
OECD QSAR Toolbox version 3.0 accessed at http://www.oecd.org/chemicalsafety/assessmentofchemicals/theoecdqsartoolbox.htm
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
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Attachment
REVIEW RIGHTS INFORMATION
If you think this decision is wrong you have the right to apply to the Administrative
Appeals Tribunal (AAT) for a review of this decision. The AAT is independent of
NICNAS.
If you want the AAT to review the decision, you must apply to the AAT within 28 days
of the date the decision was published or you received the decision. If you have good
reason for not meeting the time limit, you can write to the AAT and ask for an extension
of time, giving details of your reason(s).
Application forms are available from the AAT’s website: www.aat.gov.au.
Alternatively, you can make an application by writing a letter to the AAT. The letter
should include:





your full name
your residential and postal address(es)
your telephone number(s) and email address
the date you received the decision you want reviewed
brief reason(s) why you think the decision is wrong.
If you can, send a copy of the decision with your letter. If you can’t, include the
following details in your letter:




a brief description of the decision
the name and address of the person or organisation that made the decision
the date the decision was made
the reference number of the decision
For further information you can phone the AAT on (02) 9391 2400. If you live outside a
metropolitan area you can phone the AAT on 1300 366 700, for the cost of a local call.
If you are deaf or have a hearing or speech impairment, you can call through the
National Relay Service (www.relayservice.com.au).
The AAT’s office is at:
Level 7, City Centre Tower
55 Market Street
Sydney NSW 2000
The address for mail is:
Administrative Appeals Tribunal
GPO Box 9955
Sydney NSW 2001
Fax (02) 9283 4881
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
13
An application fee of $816 is normally payable. However, you might not have to pay all
of it. For example, if you hold a health care card or a Commonwealth seniors health card
you only pay a reduced fee of $100. If you believe you can’t afford to pay the full fee,
you can apply to pay the reduced fee of $100.
If you pay the full application fee and the application is resolved in your favour, you will
receive a partial refund. There is no refund if you have paid a reduce fee. If the
application is not resolved in your favour, you will not have to pay NICNAS’ costs.
Legal Aid offices, Community Legal Centres, or a lawyer may be able to help you with
your application. You can phone or visit the AAT to receive information about these
organisations.
Under the Freedom of Information Act 1982, any person has the right to seek access to
documents about the decision(s).
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
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3
NOTICE OF DECISION TO NOT INCLUDE ON THE AUSTRALIAN
INVENTORY OF CHEMICAL SUBSTANCES CERTAIN COSMETIC
INGREDIENTS IN PRODUCTS PREVIOUSLY REGULATED BY THE
THERAPEUTIC GOODS ADMINISTRATION
In accordance with Section 15AA(8) of the Industrial Chemicals (Notification and
Assessment) Act 1989 (the Act), this notice gives the final decision of the Director,
NICNAS, to not include two chemicals (see Table 1) on the public section of the
Australian Inventory of Chemical Substances (AICS).
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 intent of the reforms is that the
transfer of responsibility would occur whilst maintaining health and safety standards and
without posing unnecessary burden on industry.
As a result of this transfer, the chemicals in these cosmetic products that were not
already on the AICS became new industrial chemicals, and therefore required
notification and assessment unless exemptions applied. A mechanism to list certain
chemicals on the AICS as existing chemicals came into force on 27 September 2011
with amendments to the Act.
In order to be considered by the Director, NICNAS, for placement on the AICS, these
chemicals needed to meet two sets of criteria: a generic set under the amended
legislation; and a second set specific to the cosmetic reforms. To ascertain which
chemicals were to be considered for transfer, NICNAS undertook a call for information
in the February 2010 Chemical Gazette. As a result of clarifying identity information
and applying the eligibility criteria, the Director, NICNAS identified 62 chemicals or
substances for possible listing on the AICS. In addition, the Director, NICNAS must
consider whether these chemicals pose an unreasonable risk to occupational health and
safety, public health or the environment.
The proposal for not listing
These chemicals were proposed for not listing on the AICS via Notice 10 in the
Chemical Gazette of 5 June 2012.
In this Notice the Director, NICNAS stated reasons why these chemicals were proposed
for not listing on the AICS in accordance with section 15AA(5)(e) of the Act. Briefly,
these reasons were that:


when used in cosmetic products only, these chemicals may pose an unreasonable
risk to occupational health and safety, public health and the environment; and
there is insufficient information available to determine conditions under which
risk mitigation could be achieved.
Statements on the proposal were due within 28 days of the notice, by 3 July 2012.
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
15
Stakeholder response to the proposal for not listing the chemicals
One statement was received in regard to the chemicals within the 28 day period
specified under section 15AA(5)(g) of the Act. The Director, NICNAS, proposed not to
list the chemicals on AICS, noting that the chemicals possessed certain properties that
may pose a risk to human health and/or the environment. The submission objected to
the proposal not to list these chemicals on AICS on the basis that:
 NICNAS did not present any sound scientific evidence that the ingredient poses
an unreasonable risk to public health and/or the environment;
 the NICNAS restrictions are inconsistent with the use of these chemicals
internationally;
 as this proposal will have a significant detrimental impact on the commercial
operations of many companies and the supply of product into the market place,
an impact assessment is required; and
 the introduction of unique Australian requirements in the absence of any sound
scientific evidence will provide a barrier to trade and could lead to challenges
through the World Trade Organisation.
The statement included alternative proposed conditions of use within which any
unreasonable risk was proposed to be mitigated. These are shown in Table 1.
The Director’s consideration of statements received
General considerations
In relation to the statement provided above by the submitter, the Director noted in
proposal notice 10 of June 2012 that “some of the chemicals possessed certain properties
that may pose a risk to human health and/or the environment”. This observation was
informed by the application of a hazard screening process involving Quantitative
Structure Activity Relationship (QSAR) modelling and a review of literature.
Considerations regarding unreasonable risk
Section 15AA (3) requires the Director to consider whether the use of the chemical
poses an unreasonable risk to occupational health and safety, public health or the
environment.
The Director considered that the submitter did not provide any data to conclude that
these chemicals do not pose an unreasonable risk to human health and the environment,
nor to allow the determination of conditions under which risk mitigation could be
achieved. The Director has therefore determined on the basis of the available
information (see Table 1) that the original view about the unreasonable risk which may
be posed by these chemicals remains unchanged and appropriate conditions of use to
mitigate the risk cannot be prescribed.
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
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The Decision
The Director therefore makes the following decisions regarding the non-listing of the
two chemicals on the public AICS in accordance with section 15AA(7) (Table 1).
Moreover, the table is prefaced with a statement concerning how the Director took
account of the statement received.
For ease of reference, Table 1 contains:



the CAS number and INCI name/AAN in the first column;
the original conditions of use proposed by the Director in the June 2012 notice,
the conditions proposed in the stakeholder submission along with the final
conditions of use decided by the Director in the second column; and
the reasons for decision, including a summary of the scientific evidence that the
ingredient poses an unreasonable risk to public health and/or the environment, in
the third column.
Your right to apply for a review of this Decision
Under Section 15AB(1) of the Act, for each decision to not include a chemical listed in
Table 1 on the AICS, a period of at least 28 days is allowed for persons to apply to the
Administrative Appeals Tribunal (AAT) for a review of that decision. Information
concerning the right to apply to the AAT and the means of doing so is included in an
attachment to this notice. In particular, you must apply to the AAT within 28 days of
the date of this notice.
Next Steps
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 will not
include the chemicals in the public section of the AICS, and will give notice of this
action in the Chemical Gazette. Pending any application for review to the AAT,
NICNAS expects these processes to occur on 7 May 2013 at the earliest.
Arrangements for annual reporting of chemicals under Sn15AA process
The chemicals in Table 1 which the Director has decided not to transfer to the AICS under
section 15AA of the Act will continue to be new chemicals and so remain subject to the
premarket notification and assessment requirements and/or post market reporting obligations
under Part 3 Division 1 of the Act.
If you require further information please contact Dr Bin Fang, bin.fang@nicnas.gov.au,
Reform Section, NICNAS
GPO Box 58
Sydney NSW 2001
Freecall: 1800 638 528
Phone: 02 8577 8825
Fax: 02 8577 8888
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
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Table 1: Chemicals decided not to be included on the Australian Inventory of Chemical Substances under Section 15AA(7) of the Industrial
Chemicals (Notification and Assessment) Act 1989
The following chemicals were proposed for not listing on the AICS. The statement received requested listing of these chemicals on the AICS
with a condition of use based on the controls imposed by the previous regulator (the Therapeutic Goods Administration). No data were provided
by the submitter to support that the chemicals do not pose an unreasonable risk to human safety and the environment. Therefore the Director has
determined on the basis of the available information that the original view about the unreasonable risk which may be posed by these chemicals
remains unchanged.
CAS No.
INCI name/AAN
329360-59-0
Ajuga Turkestanica
Extract
Conditions of Use:
4. As originally proposed
5. As proposed in statement received
6. As decided
4. Not listed on the AICS.
5. Listed on the AICS for Cosmetic Use Only. For
topical use only and not to exceed a concentration
of 0.08%.
6. Not listed on the AICS.
Reasons for Decision
Based on the potential for adverse effects to
insects and in the absence of information to
alleviate these concerns, it is decided that ajuga
turkenstanica extract be not listed on AICS.
The chemical has concerns relating to anabolic
activity. Ajuga contains at least three classes of
potentially bioactive compounds: clerodane
diterpenes, phytoecdysteroids and iridoid
glycosides. Clerodane diterpenes are known for
their activity as insect allelochemicals (Camps F,
1993; Klein Gebbinck EA, 2002). Both the
clerodane diterpenoids and the phytoecdysteroids
with potential insect antifeedant and moulting
hormone activities, respectively, may work
interactively to potentiate the bioactivity of the
Ajuga plants (Camps F, 1993). No national or
international assessment of the risk to the
Chemical Gazette 2013
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223748-52-5
Coleus Barbatus Extract
(AHN: Coleus forskohlii)
1. Not listed on the AICS
2. Listed on the AICS for Cosmetic Use Only.
3. Not listed on the AICS
environment from wide dispersive release has
been identified.
Based on the potential for adverse reproductive
effects and in the absence of additional
information to alleviate these concerns, it is
decided that coleus barbatus extract be not listed
on AICS.
The chemical has been reported to affect embryo
implantation rates in rats and induce
cardiovascular malformations in the chick
embryo (Almeida, 2000; Nishikawa,1989;
Nishokawa 1995). No national or international
risk assessments of the chemical have been
identified. A level for which no adverse effects
are observed could not be established from the
available data and hence a concentration which
would establish an adequate margin of safety
could not be defined.
References
Almeida FCG, Lemonica IP (2000). The toxic effects of Coleus barbatus B. on the different periods of pregnancy in rats. J Ethnopharmacol,
73: 53-60.
Camps F (1993) Insect allelochemicals from Ajuga plants. Phytochemistry, 32 (6), 1361-1370.
Klein Gebbinck EA, Jansen BJ, de Groot A (2002) Insect antifeedant activity of clerodane diterpenes and related model compounds.
Phytochemistry, 61(7):737-70.
Nishikawa T et al. (1989). A tetratogenic effect of forskolin on cardiovascular development in the chick embryo. Reprod Toxicol., 3(2);139-42.
Nishikawa T et al. (1995). The effect of forskolin on tetratogenicity of methylxanthines in the chick embryo heart. Reprod Toxicol., 9(2):165-8.
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
20
Attachment
REVIEW RIGHTS INFORMATION
If you think this decision is wrong you have the right to apply to the Administrative Appeals
Tribunal (AAT) for a review of this decision. The AAT is independent of NICNAS.
If you want the AAT to review the decision, you must apply to the AAT within 28 days of the
date the decision was published or you received the decision. If you have good reason for not
meeting the time limit, you can write to the AAT and ask for an extension of time, giving
details of your reason(s).
Application forms are available from the AAT’s website: www.aat.gov.au. Alternatively you
can make an application by writing a letter to the AAT. The letter should include:





your full name
your residential and postal address(es)
your telephone number(s) and email address
the date you received the decision you want reviewed
brief reason(s) why you think the decision is wrong.
If you can, send a copy of the decision with your letter. If you can’t, include the following
details in your letter:




a brief description of the decision
the name and address of the person or organisation that made the decision
the date the decision was made
the reference number of the decision
For further information you can phone the AAT on (02) 9391 2400. If you live outside a
metropolitan area you can phone the AAT on 1300 366 700, for the cost of a local call. If you
are deaf or have a hearing or speech impairment, you can call through the National Relay
Service (www.relayservice.com.au).
The AAT’s office is at:
Level 7, City Centre Tower
55 Market Street
Sydney NSW 2000
The address for mail is:
Administrative Appeals Tribunal
GPO Box 9955
Sydney NSW 2001
Fax (02) 9283 4881
An application fee of $816 is normally payable. However, you might not have to pay all of it.
For example, if you hold a health care card or a Commonwealth seniors health card you only
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
21
pay a reduced fee of $100. If you believe you can’t afford to pay the full fee, you can apply to
pay the reduced fee of $100.
If you pay the full application fee and the application is resolved in your favour, you will
receive a partial refund. There is no refund if you have paid a reduce fee. If the application is
not resolved in your favour, you will not have to pay NICNAS’ costs.
Legal Aid offices, Community Legal Centres, or a lawyer may be able to help you with your
application. You can phone or visit the AAT to receive information about these organisations.
Under the Freedom of Information Act 1982, any person has the right to seek access to
documents about the decision(s).
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
22
4
REVIEW OF ARRANGEMENTS FOR SCHEDULING SUBSTANCES
The Australian Government Department of Health and Ageing is facilitating a review of the
arrangements for the scheduling of medicines and poisons in accordance with Section 52EC of
the Therapeutic Goods Act 1989 (the Act). The review will be undertaken by an independent
panel and will have particular regard to amendments made by Parliament to Part 6-3 of the Act
in 2009. The review will report on:
(a)
the system of access controls for goods containing scheduled substances
(b)
the outcomes of the administration of scheduled substances by the Secretary and by
the associated committees
(c)
the effect of the amendments on the therapeutic goods industry and on individual
parties within the industry
(d)
whether there are adequate avenues for review of decisions made by the Secretary
and may make recommendations of further changes to the scheduling regime.
For more information about the review and how to make a submission please visit
http://www.health.gov.au/internet/main/publishing.nsf/content/ohp-ocs.htm
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
23
5
NEW CHEMICALS FULL PUBLIC REPORTS
Reference
Number
Applicant
Chemical or
Trade Name
Hazardous
Substance
LTD/1544
Firmenich
Limited
Walnut Ester
Yes
LTD/1604
DIC Australia
Pty Ltd
ND
≤ 10 tonnes
per annum
LTD/1645
Unilever Asia
Private
Limited
No
≤ 1 tonne per
annum
STD/1400
Shell
Company of
Australia Ltd
Polymer in
Suncure Starluxe
& Suncure Lazer
Inks
1,2,3Propanetriol,
homopolymer,
ether with methyl
Dglucopyranoside
dioctadecanoate
(INCI name:
Polyglyceryl-3
Methylglucose
Distearate)
Chemical in
Aeroshell
Ascender
No
≤ 200 tonnes
per annum
STD/1416
Honeywell Ltd
OC-1600
Crosslinking
agent
Yes
≤ 10 tonnes
per annum
STD/1430
L'Oreal
Australia Pty
Ltd
Distearyl Ether
No
≤ 10 tonnes
per annum
STD/1445
Afton
Chemical Asia
Pacific LLC
Epson
Australia Pty
Ltd
U-POL
Australia Pty
Ltd
Chemical in
HiTEC 4898C
Fuel Additive
NEJI-34
ND
≤ 150 tonnes
per annum
No
≤ 1 tonne
per annum
Polymer in
Synolite 7044-M1
ND
<3 tonnes per
annum
PLC/1111
EX/177
Chemical Gazette 2013
Introduction
Volume (per
annum)
≤ 1 tonne per
annum
Use
Component
of cosmetic
and
household
cleaning
products
Component
of ink for
lithographic
printing
Component
of rinse-off
and leave-on
cosmetic
products
Component
of engine oil
for aviation
applications
Crosslinking
agent for
silicone
sealant and
adhesive
formulations
Component
of rinse-off
and leave-on
cosmetic
products
Diesel fuel
additive
Component
of inkjet
printer ink
Component
of automobile
putties
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
24
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 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
25
6
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 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 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
26
7
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
889
890
891
892
896
Chemical Gazette 2013
COMPANY
NAME
Akzo Nobel
Pty Ltd
M-I Australia
Pty Ltd
Akzo Nobel
Pty Ltd
M-I Australia
Pty Ltd
Ricoh
Australia Pty
Ltd
CHEMICAL OR
TRADE NAME
USE
Chemical 1 in Dissolvine Chelating agent used in offshore
GL-NA-33
oil and gas production processes
Chemical 2 in Dissolvine Chelating agent used in offshore
GL-NA-33
oil and gas production processes
Polymer in SU-U1244
Component of ink for commercial
inkjet printers
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
27
8
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
990
Océ Australia
Ltd
3168
Setafix 1077
No
Component
of ink for
ink jet
printers
991
Océ Australia
Limited
3168
Setafix 1079
No
Component
of ink for
ink jet
printers
997
(Renewal)
Canon Australia 2113
Pty Ltd
Chemical in Canon
Yellow Ink Tank for
Ink Jet Printer
ND
Component
of ink for
ink jet
printers
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)]
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
28
9
CONTROLLED USE PERMITS
The permits listed in Table 3 were issued to import or manufacture the following chemicals for
controlled use under section 22B of the Industrial Chemicals (Notification and Assessment) Act
1989.
Table 3
Controlled Use Permit
PERMIT
NUMBER
19
COMPANY
NAME
IMCD
Australia Ltd
Chemical Gazette 2013
COMPANY
POSTCODE
3170
CHEMICAL OR
TRADE NAME
Polyhexamethyl
biguanide stearate
HAZARDOUS
SUBSTANCE
Yes
QUANTITY
KG
4000
USE
Ingredient
in personal
deodorants
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
PERIOD
APPROVED
MONTHS
36
29
10
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
MOLECULAR FORMULA
CAS NUMBER
Oxirane, methyl-, polymer with 2,4diisocyanato-1-methylbenzene and
oxirane, 1H-imidazole-1propanamine- and 2-oxepanone
homopolymer C10-rich C9-11branched and linear alkyl esterblocked
Unspecified
398475-97-3
Hexanedioic acid, polymer with 5amino-1,3,3trimethylcyclohexanemethanamine,
1,4-butanediol, 2,2-dimethyl-1,3propanediol, 1,6-hexanediol, 5isocyanato-1-(isocyanatomethyl)1,3,3-trimethylcyclohexane, 4,4'-(1methylethylidene)bis[phenol] and 2methyloxirane, 2-ethyl-1-hexanolblocked
(C15H16O2.C12H18N2O2.C10H22N2.C8
H18O.C6H14O2.C6H10O4.C5H12O2.C4
H10O2.C3H6O)x
109159-24-2
2H-Azepin-2-one, 1ethenylhexahydro-, telomer with 1ethenyl-2-pyrrolidinone and 2propanol
(C8H13NO.C6H9NO)x.C3H8O
683239-21-6
Benzenesulfonamide, 2-methyl-,
reaction products with bisphenol Aepichlorhydrin polymer and 4methylbenzenesulfonamide
(C15H16O2.C7H9NO2S.C7H9NO2S.C3
H5ClO)x
130353-62-7
2-Oxepanone, polymer with 1,6diisocyanatohexane and 2-ethyl-2(hydroxymethyl)-1,3-propanediol
(C8H12N2O2.C6H14O3.C6H10O2)x
129757-76-2
Fatty acids, soya, polymers with
benzoic acid, 3-hydroxy-2(hydroxymethyl)-2-methylpropanoic
acid, 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane, isophthalic
(C12H18N2O2.C8H6O4.C8H4O3.C7H6O
106214-63-5
2.C6H15N.C5H12O4.C5H10O4.Unspeci
fied)x
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
30
acid, pentaerythritol and phthalic
anhydride, compds. with
triethylamine
1,2-Propanediol, 3-amino-, N,Ndicoco alkyl derivs.
Methanone, bis(4-fluorophenyl)-,
polymer with 1,4-benzenediol
2-Propenoic acid, 2-methyl-, sodium
salt (1:1), polymer with
ethenylbenzene telomer with 3mercaptopropanoic acid 2-hydroxy-3[(2-methyl-1-oxo-2-propen-1yl)oxy]propyl ester, .alpha.-(2methyl-1-oxo-2-propen-1-yl).omega.-hydroxypoly[oxy(methyl-1
,2-ethanediyl)] and .alpha.-(2methyl-1-oxo-2-propen-1-yl).omega.-methoxypoly(oxy-1,2ethanediyl)
Unspecified
897393-64-5
(C13H8F2O.C6H6O2)x
29658-26-2
((C8H8)x.xC7H12O4.C4H6O2.C3H6O2S
.(C3H6O)nC4H6O2.(C2H4O)nC5H8O2. 1418831-87-4
Na)x
2-Propenoic acid, 2-methyl-, polymer
with ethenylbenzene telomer with 3mercaptopropanoic acid 2-hydroxy-3[(2-methyl-1-oxo-2-propen-1yl)oxy]propyl ester, .alpha.-(2methyl-1-oxo-2-propen-1-yl).omega.-hydroxypoly[oxy(methyl1,2-ethanediyl)], .alpha.-(2-methyl-1oxo-2-propen-1-yl)-.omega.methoxypoly(oxy-1,2-ethanediyl) and
phenylmethyl 2-methyl-2-propenoate,
sodium salt
(C11H12O2.(C8H8)x.xC7H12O4.C4H6O
2.C3H6O2S.(C3H6O)nC4H6O2.(C2H4O
)nC5H8O2)x.xNa
1423729-41-2
2-Butenedioic acid (2Z)-, 1-methyl
ester, polymer with 1,2-propanediol
mono(2-methylpropenoate) and 2propenoic acid, ammonium salt, tertBu peroxide-initiated
Unspecified
1424937-23-4
Butanoic acid, 3-oxo-, ethyl ester,
reaction products with acetylacetone,
acrylic acid-bisphenol A diglycidyl
ether-2-[(C10-16alkyloxy)methyl]oxirane polymer,
and N-butyl-1-butanamine,
diethanolamine, 1,6-hexanediyl
diacrylate and trimethylolpropane
triacrylate
Unspecified
1424938-28-2
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
31
2-Propenoic acid, 2-methyl-, butyl
ester, polymer with ethenylbenzene,
ethenylbenzene telomer with 3mercaptopropanoic acid 2-hydroxy-3[(2-methyl-1-oxo-2-propen-1yl)oxy]propyl ester, 2-methyloxirane
polymer with oxirane mono(2methyl-2-propenoate) 2-ethylhexyl
ether, and sodium 2-methyl-2propenoate (1:1)
Chemical Gazette 2013
(C8H18O.C8H14O2.(C8H8)x.C8H8.xC7
H12O4.C4H6O2.C4H6O2.C3H6O2S.(C3
H6O.C2H4O)x.Na)x
1423729-43-4
Commonwealth of Australia Gazette
No. C 01, 02 January 2013
32
11
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
MOLECULAR FORMULA
CAS
NUMBER
2-Pentandione, O,O',O"(methylsilylidyne)trioxime
C16H33N3O3Si
37859-55-5
1,6-Hexanediamine, N1,N6-bis(1,2,2trimethylpropyl)-
C18H40N2
957787-76-7
Pentanoic acid, 3-methyl-2-oxo-, ethyl
ester
C8H14O3
26516-27-8
1,2,3-Propanetriol, homopolymer, ether
with methyl D-glucopyranoside
dioctadecanoate
C43H82O8.x(C3H8O3)x
187339-62-4
Chemical Gazette 2013
Commonwealth of Australia Gazette
No. C 01, 02 January 2013