GUIDELINES
Applying for certain information to be exempt from
publication by NICNAS
and
Establishing a case for confidential listing of chemicals on
the Australian Inventory of Chemical Substances
December 2014
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Contents
Background .................................................................................................................... 3
Purpose of these guidelines ............................................................................................ 3
Making an application.................................................................................................... 4
Exempt information ................................................................................................... 4
Confidential listing..................................................................................................... 5
Forms ......................................................................................................................... 5
What information is required from the applicant? ......................................................... 6
Commercial interest criteria ........................................................................................... 6
Public interest criteria .................................................................................................... 8
Making a decision ........................................................................................................ 11
Exempt information ................................................................................................. 11
Confidential listing................................................................................................... 12
Options available to an applicant if the decision is to reject an application ................ 12
Exempt information ................................................................................................. 12
Confidential listing................................................................................................... 13
The AAT .................................................................................................................. 13
Attachment A ............................................................................................................... 14
Attachment B ............................................................................................................... 17
Attachment C ............................................................................................................... 19
Attachment D ............................................................................................................... 20
Attachment E ............................................................................................................... 21
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Background
In Australia, industrial chemicals are regulated under the Industrial Chemicals
(Notification and Assessment) Act 1989 (the ICNA Act). The National Industrial
Chemicals Notification and Assessment Scheme (NICNAS) administers the ICNA
Act to aid in the protection of the Australian people and the environment by assessing
the risks of industrial chemicals and providing information to promote their safe use.
NICNAS maintains the Australian Inventory of Chemical Substances (AICS), which
is the legal device that distinguishes new industrial chemicals from existing industrial
chemicals in Australia. The AICS consists of a confidential section and a nonconfidential section. The purpose of the confidential section of the AICS is to allow
introducers of chemicals to maintain confidentiality over a chemical’s particulars,
subject to legislated criteria being met.
Purpose of these guidelines
These guidelines are intended to assist:
 applicants to prepare applications for:
o listing/re-listing of an industrial chemical on the confidential section of
the AICS (referred to in these guidelines as a confidential listing
application); and
o certain information given to NICNAS to be treated as exempt from
publication (referred to in these guidelines as an exempt information
application);
 NICNAS staff to review applications for exempt information and confidential
listing/relisting; and
 the Director of NICNAS (the Director) to make decisions on these
applications.
These guidelines are not intended to:
 specify the information that must be provided with each application;
 provide legal advice on the interpretation of the various sections of the ICNA
Act governing confidential listing or exempt information applications;
 detail the steps applicants must take when seeking review of a decision in the
Administrative Appeals Tribunal (AAT—refer below for further information);
or
 provide an exhaustive list of what data/arguments might satisfy the statutory
test (refer below for details on the statutory test) in all situations.
Applicants should consider how the information contained in these guidelines could
be relevant to their own particular circumstances when making an application.
Attachment A provides answers to some common questions about these processes.
Background information on the AICS and provisions for exempt information and
confidential listing are provided in Attachment B. Flow charts of the process
undertaken by NICNAS for confidential listing/re-listing and exempt information
applications are in Attachments C and D, respectively. Attachment E contains
hypothetical examples of successful and unsuccessful applications for confidential
listing and exempt information for new chemical applications.
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Making an application
The ICNA Act sets out the process (known as a ‘statutory test’—see Attachment A
Q2 for further information) to be followed when:
a) including a chemical in the confidential section of the AICS;
b) transferring a chemical from the non-confidential section to the confidential
section of the AICS (and vice versa); and
c) granting exemption from publication for certain information given to
NICNAS.
The statutory test is identical in all these circumstances. It requires that the decision
maker, who is the Director or delegate of the Director1, be satisfied that publishing
some or all of the information could reasonably be expected to prejudice substantially
the commercial interests of the applicant, and that this prejudice outweighs the public
interest with respect to publishing that information. It is assumed the information is
confidential in nature and the test does not require the applicant to prove the
information is confidential. Rather, the test is to decide if NICNAS is justified in not
publishing the confidential information.
The terms ‘commercial interest’ and ‘public interest’ are not defined in the ICNA Act
or Regulations, but in all cases their scope will be limited by the objects of the Act.
Further explanation of these terms is provided in Attachment A (Q6 and Q7).
Applicants are free to provide all relevant information and argument they consider
would help the Director to make a decision. It is important to note that the Director
can only take relevant considerations into account and cannot take into account
irrelevant considerations. Further explanation of these terms is provided in
Attachment A (Q9 and Q10).
While the statutory test is the same under circumstances a, b and c above, this does
not mean that the type of relevant information and argument that might satisfy the
decision maker would be the same for each case. Each of the above categories will
have different types and levels of information available to applicants and will require
differing arguments to support applications.
Exempt information
For any information to be exempted from publication, a person must make an
application to the Director, providing reasoned argument supported by data and/or
other evidence where available. There are fees associated with making an application
(see the NICNAS website www.nicnas.gov.au).
Applications for information to be exempted from publication can be submitted with:
 Annual reporting obligations
 Commercial evaluation permit applications or renewal applications
 Low volume chemical permit applications or renewal applications
 Controlled use permit applications or renewal applications
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References in these guidelines to decisions made by the Director include decisions made by a delegate
of the Director where appropriate.
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Non-self-assessed and self-assessed assessment certificate applications, further
information supplied by the applicant and associated requests from the
Director for further information.
Extension of original assessment certificate applications
Early introduction permit applications
A statement of matters given to the Director under approved state and territory
notification procedures [Note, none currently in operation]
Particulars about a new industrial chemical where the chemical has been
notified and assessed under an approved foreign scheme
Information about the use and introduction of existing chemicals given to the
Director for decision on recommendation to declare a priority existing
chemical
Information about a priority existing chemical
Secondary notification applications
An exempt information application will be considered internally within NICNAS and
a decision made by the Director.
The Director must not grant an exempt information application in relation to ‘basic
information’ about a chemical. The definition of ‘basic information’ in the ICNA Act
and Regulations and is reproduced in Attachment A, Q12.
Confidential listing
To list a chemical in the confidential section of the AICS (or to maintain listing in the
confidential section, which is reviewed every five years), the holder of the assessment
certificate must make an application to the Director. There are fees associated with
making an application (refer to the NICNAS website www.nicnas.gov.au). For an
application to be successful (that is, for the Director to be satisfied that the
requirements of the statutory test have been met), reasoned argument supported by
data (where available) and/or other relevant evidence should be provided with the
application.
A confidential listing application is initially considered within NICNAS and a
recommendation made to the Director. The Director will then decide whether to grant
confidential listing.2
Forms
Applications are to be made on the approved form. Approved forms are available
from the NICNAS website (http://www.nicnas.gov.au). Approved forms are intended
to help applicants provide information expected to be relevant to the consideration of
their application. Applicants may provide additional information that they regard as
relevant to their application. Forms include a declaration, which must be signed by an
authorised officer of the applicant. In making the declaration, applicants should be
aware that penalties can apply for making statements that are false or misleading.3
2
Under the ICNA Act this power cannot be delegated by the Director.
3
Criminal Code Act 1995 Part 7.4
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What information is required from the applicant?
Decisions are made on a case-by-case basis and NICNAS might seek clarification or
further information from the applicant. If so, the applicant is given a specific
timeframe within which to respond, generally not less than 28 days.
The applicant may provide whatever reasoned argument and available data or other
evidence that they feel addresses the commercial and public interest elements of the
statutory test supporting their exempt information application or confidential listing
application. The types of information that may help the Director to make a decision
are discussed below.
Data and arguments supporting an exempt information application might be different
from data and arguments supporting a confidential listing. While applicants for
exempt information might not have commercial sales data to which they can refer,
they still need to consider relevant matters and provide data where available. If data
are not available, an estimate would assist the decision-maker. In general, the more
data provided in support of an application, the stronger the case is likely to be.
Where applicable, applicants seeking confidential listing should provide information
that might have become available since the NICNAS new chemical assessment was
completed. Similarly, applications for confidential re-listing could include
information that has become available since the previous confidential listing decision.
This enables NICNAS to check that the conclusions and recommendations of the
original assessment are still relevant, or whether new information requires
consideration.
Applicants are reminded that information relating to secondary notification
requirements should be provided to NICNAS within 28 days of the applicant
becoming aware of the information. Further information on secondary notification is
provided on the NICNAS website (www.nicnas.gov.au).
Commercial interest criteria
The first part of the statutory test relates to an applicant’s commercial interests. In
particular, the Director must consider whether the applicant’s commercial interests
could reasonably be expected to be prejudiced by publishing some or all of the
information. Furthermore, the Director must be satisfied that the prejudice to the
applicant’s commercial interests is substantial. If the Director is not satisfied of this,
the application cannot be granted. A commercial interest regarding the chemical is
assumed if the application is for exempt information accompanying a notification of a
new chemical; however, the Director must still consider whether the prejudice to the
applicant’s commercial interests is ‘substantial’ before weighing that commercial
interest against the public interest.
It is the responsibility of the applicant to explain why public disclosure of the
information would have a substantially detrimental effect on the applicant’s business.
This may be done by:
 describing the pathway from publication of the information to commercial
loss, such as competitive advantage, intellectual property, or product and/or
corporate viability;
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describing or estimating (where possible) the loss in the context of the
business entity; and/or
describing or estimating (where possible) the potential damage to the business
(in Australia and/or globally), or to developing the next generation technology,
where applicable.
Answers to the following questions might be relevant to the Director’s consideration
of the first part of the statutory test, although not all matters will be relevant to every
application, and other matters may also be relevant. It is recognised that information
available and relevant at pre-market notification (i.e. request for exempt information)
could be different from that available and relevant once the chemicals are on the
market (i.e. confidential listing application). Applicants should use this list as a guide
only—it is neither exhaustive nor applicable to every situation, and should not limit
the type of supporting information provided.
(a)
How will disclosure of the chemical identity/information lead to commercial
loss for your business?
Estimate the loss if possible. Consider factors such as:
1. immediate and longer-term losses;
2. the potential for commercial loss locally and internationally;
The estimated loss could be supported by information/data such as:
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modelling and statement of assumptions regarding the commercial
impact from publishing the information, which could include an
estimation of the decrease in dollar value and/or market share of sales
of the chemical if the information were published, and an explanation
of how that decrease was estimated;
data estimating the actual or expected market share of sales of the
chemical;
projected figures on the commercial interest and market value of the
chemical developed as part of a business plan;
data on the size of the market for the chemical, for example, a small
dollar value loss of sales could be relevant in a small total market;
description of the role of the chemical as part of new technology that
has not, at the time of application, reached its full commercial
potential.
(b)
Has the chemical been publicly identified in a chemical inventory of another
country? If so, in which country(ies) or inventory(ies) is it published? Discuss
how confidential listing or exemption from publication in Australia will
protect commercial interests despite publication of this information elsewhere.
(c)
Has the substance already been granted confidential status in a chemical
inventory of another country, based on commercial interests? If so, this
information should be provided.
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(d)
Has confidential listing in any jurisdiction been sought and denied? If so, the
reasons should be provided, if available.
(e)
What measures have been taken by the owner to protect the confidential nature
of the information, including in manufacturing and importing the substance?
(f)
Has the substance been identified by other than trade or generic names in
journals, books or other public sources. If so, information should be provided
on why granting confidential status in Australia is required to protect
commercial interests.
(g)
Has the substance and/or its use been patented? Applicants should provide
copies of patent(s) relevant to the use of the chemical in Australia and
comment as to how the failure to grant confidential status will harm their
commercial interests. Patent coverage may not necessarily involve transparent
disclosure of the substance, the manufacturing process, or the use/application
of the chemical.
Provided the application has adequate justification, the existence of a patent
does not militate against granting the application when it does not specifically
reveal the chemical name (or it cannot be gleaned from the patent). However,
the case for confidential listing might be weakened when patents disclose
sufficient detail to bring the chemical identity into the public domain.
Applicants should state what is disclosed by the patent, and argument as to
why publication of a chemical’s particulars, or listing on the non-confidential
AICS, provides information that is not otherwise available.
(h)
Is the name of the substance required to be disclosed on an SDS? Applicants
should provide a copy of any relevant SDS. Provided the application has
adequate justification, the existence of an SDS disclosing the chemical name
does not militate against granting the application. There are cases where a
chemical’s SDS is not available to the public, but only available to commercial
clients who may, for example, be using small quantities of the chemical in a
reformulation. In such cases, access to the SDS may be restricted and the
chemical’s identity is thus not publicly known.
When the applicant has demonstrated that the publication of some, or all, of the
information could reasonably be expected to substantially prejudice the commercial
interests of the applicant, the second part of the statutory test is applied.
Public interest criteria
The second part of the statutory test relates to the public interest. In particular, the
Director must consider the relative weight to be given to the substantial prejudice
caused to the applicant’s commercial interests, against the interests of the Australian
people, in publishing the information.
There is no definition of what ‘the public interest’ is in any given set of circumstances
(see Attachment A Q7). However, information the disclosure of which is justified as
being in the public interest, is not the same as information that is merely of interest to
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some members of the public. The Explanatory Memorandum to the Industrial
Chemicals (Notification and Assessment) Amendment Bill 1997 suggests that the
public interest, in this particular context, can include whether or not the chemical is
hazardous and whether the chemical is published in relevant inventories overseas.
Consideration of the public interest is also limited by the objects of the ICNA Act
(refer to Attachment A Q8 for details).
Applicants need to be aware of the matters of most concern to the general public.
These include (but are not limited to):
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how much is known of the toxicity and ecotoxicity of the chemical;
whether or not there is wide consumer use and hence potential exposure to the
chemical and/or its degradation products;
whether or not the chemical is taken up by living organisms (persistent and
bioaccumulative); and
the means used to dispose of chemical waste.
Applicants should provide all relevant information accessible to them. Applicants do
not need to undertake additional chemical testing or provide additional test reports
unless requested by NICNAS to address gaps in relevant information. Where a
substance has been identified as hazardous, providing monitoring data will assist in
consideration of the application. Chemicals in this category would include those of
international concern, such as potential endocrine disrupters. Occasionally, where
NICNAS has assessed the chemical, the assessment report might note that future
monitoring or testing is to be undertaken. Applicants subsequently seeking
confidential listing or re-listing on the AICS should check if this work has been done,
and include the outcomes in their application.
Confidential listing applications should:
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ideally, refer to the original NICNAS assessment
provide any new information relevant to the application
provide information addressing the matters listed below.
While applications for exempt information may not have a previous NICNAS
assessment to refer to, applicants still need to consider relevant matters and provide
data where available. If information is not available, an explanation is required. In
general, the more data provided in support of an application, the stronger the case.
The case is strengthened, particularly for hazardous substances, by the provision of
monitoring data on the fate of and on the human health and environmental effects of
the chemical.
The following matters might be relevant to the public interest component of the
statutory test, although not all matters will be relevant to every application (applicants
should treat this list as a guide only—it is neither exhaustive nor applicable to every
situation).
(a)
The likelihood of beneficial impacts flowing from using the chemical.
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Examples could include benefits to society from its use such as replacement of
old, more harmful chemistry (replacing chemicals or processes harmful to
human health and the environment, with less harmful ones).
(b)
The potential impact on innovation in Australia, or available to Australians.
(c)
The public availability of data, including data from other countries, concerning
the properties, fate or effects of the chemical substance.
Chemical information might be available in literature reports, media reports
and other published sources including the Internet.
(d)
Exposure patterns for workers, the public and the environment, both short and
long term, in manufacturing, using, transporting and disposing of the chemical.
While exposure scenarios considered in the new chemical assessment do not
need to be reproduced, applicants need to describe new exposure scenarios that
might not have been assessed by NICNAS. Information on special or new
technological controls to reduce exposure (for example, using special
containment facilities, special training for workers, or special packaging)
might need to be included.
Similarly, situations likely to increase exposure (such as using casual or
contract workers) might need to be mentioned, with an explanation of how risk
controls for these workers (transferring information on chemical hazards,
exposure controls and worker training) are being implemented to minimise
exposure. Exposure patterns will be used to consider the risks posed by
hazardous substances.
(e)
The type of information available to the public (in Australia) on the chemical,
for example product sheets and brochures for the chemical and its products, or
on the operations of the chemical industry sites that handle the chemical
substance.
(f)
Information on adverse incident reporting mechanisms for workers, including
contract workers, to alert employers to problems with chemicals.
(g)
Information on the potential of the chemical substance or degradation products
or by-products or wastes from its manufacture or formulation to cause adverse
short-term or long-term impacts directly or synergistically on human health
and/or in the environment.
(h)
Results from monitoring studies for the chemical, by-products, degradation
products, or wastes; and their level of compliance with State and Territory
standards and licences, where relevant.
(i)
Whether disclosure of the chemical identity is required under other Australian
Commonwealth State or Territory legislation. For example, hazardous
substances regulations, poisons scheduling, environmental regulations, the
National Pollutant Inventory etc.
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(j)
How environmental, public and workers’ health and safety could be
compromised by the chemical’s inclusion on the confidential section of AICS.
(k)
That the applicant has made sufficient information available to enable the
substance to be tracked, including residues, metabolites and/or degradation
products, in the environment.
(l)
Whether a safety data sheet (SDS) is available to workers and the public, and
describe how a person can access the SDS.
Note: a current SDS is required with an application for confidential listing.
Making a decision
Exempt information
For an application for exempt information to succeed, the Director must be satisfied
(taking into account information provided by the applicant and the objects of the
ICNA Act) that the:
 applicant’s commercial interests would be prejudiced by the publication of the
information;
 prejudice to the applicant’s commercial interests would be ‘substantial’; and
 public interest in the publication of the information is outweighed by the
substantial prejudice to the applicant’s commercial interests.
Decisions are made on a case-by-case basis. Reasoned argument supported by
relevant data and other relevant evidence submitted by the applicant will be
considered.
Applications for exempt information relating to a new chemical assessment cannot
generally be decided until the assessment is complete. However, because of the many
different new chemical notification categories (eg standard, polymer of low concern,
controlled use permit) and the different data that applicants could seek as exempt from
publication, it is sometimes possible for a decision to be made in a shorter time frame.
NICNAS will aim to give applicants an indication of any issues with the exempt
information application at screening. Applicants may withdraw a new chemical
assessment before the certificate or permit is issued. A partial refund of the new
chemical assessment application fee may be possible (see the refund policy table in
the NICNAS handbook – screening applications to notify a new chemical).
Applications that relate to matters other than a new chemical will be generally be
decided with 20 business days of receipt by NICNAS of payment of any applicable
fee and all data needed for the Director to make a decision.
Applicants are notified of the Director’s decision in writing (subsection 75(3)). Refer
below for the applicant’s right to apply for the Director’s decision to be reviewed by
the Administrative Appeals Tribunal (AAT).
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Confidential listing
For an application for confidential listing to succeed, the Director must be satisfied
(taking into account information provided by the applicant and the objects of the
ICNA Act) that the:
a) applicant’s commercial interests would be prejudiced by the publication of the
information;
b) prejudice to the applicant’s commercial interests would be ‘substantial’; and
c) public interest inherent in the publication of the information is outweighed by
the substantial prejudice to the applicant’s commercial interests.
The Director is required to make a decision based on the information provided by the
applicant. It would be difficult for the Director to decide in favour of the applicant on
the basis of assertions by an applicant that are not substantiated by reasoned argument
or data (refer to Attachment A Q4) that demonstrate the substantial nature of the
prejudice to the commercial interests of the applicant that would arise from listing the
chemical in the non-confidential section of the AICS.
The Director is more likely to be able to decide in favour of the applicant if the
application is supported by relevant evidence and reasoned argument demonstrating
the prejudice that could reasonably be expected to arise from publishing information
about the chemical, and why this prejudice outweighs the public interest from
publishing this information.
In making a decision on any aspect of the test, the Director will not be justified in
granting the application unless, at the time the decision is made, the Director has real
and substantial grounds for thinking that publishing the information could be expected
to substantially prejudice the applicant’s commercial interests and that any such
prejudice would outweigh the public interest from publishing the information.
Applications that relate to matters other than a new chemical will generally be decided
with 20 business days of receipt by NICNAS of payment of any applicable fee and all
data needed for the Director to make a decision.
Applicants are notified of the Director’s decision in writing (subsection 14(5)). Refer
below for the applicant’s right to apply for the Director’s decision to be reviewed by
the Administrative Appeals Tribunal (AAT).
Options available to an applicant if the decision is to reject an application
Exempt information
If an exempt information application accompanying a new chemical assessment is
refused, the assessment application may be withdrawn before the certificate or permit
is issued. A partial refund of the new chemical assessment application fee may be
possible (see the refund policy table in the NICNAS handbook – screening
applications to notify a new chemical).
Decisions made by the Director regarding exempt information applications are
reviewable by the AAT under section 102 of the ICNA Act. Under section 75(4) of
the ICNA Act, an application is not taken as finalised for the purposes of exempt
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information for 28 (calendar) days after the giving notice of the decision or, where the
applicant applies during that time to the Tribunal under section 102 for review of the
decision, until the application to the Tribunal is finalised.
Confidential listing
Decisions made by the Director regarding confidential listing applications are
reviewable by the AAT under section 102 of the ICNA Act. Under section 14(6) of
the ICNA Act, where the Director decides not to include the chemical in the
confidential section, he or she must delay including the chemical in the Inventory for
28 (calendar) days after giving notice of the decision or, where the applicant applies
during that time to the Tribunal under section 102 for review of the decision, until the
application to the Tribunal is finalised.
Should an applicant apply to the AAT for review and the Director’s decision is
affirmed, the chemical will be listed on the non-confidential section of the AICS,
unless an appeal from the AAT decision is made to the Federal Court of Australia.
Once a chemical is listed on the non-confidential section of the AICS there are limited
circumstances in which the chemical can be transferred to the confidential section, or
alternatively removed from the AICS entirely.
The AAT
An application for review to the AAT must be lodged within 28 days of the Director’s
decision.
Information that is the subject of an exempt information application cannot be
published before the AAT review of the Director’s decision is finalised. In the case of
an exempt information application relating to a new chemical, the permit or certificate
will not be issued until this period has elapsed or any available appeal has been
finalised.
Similarly, a chemical that is the subject of a confidential listing application cannot be
listed in the non-confidential section until an AAT review is finalised.
To assist applicants in deciding whether to appeal the Director’s decision, the decision
will set out the findings on material questions of fact, refer to the evidence or other
material on which those findings were based and give the reasons for the decision (see
Attachment E).
Further information on the AAT review process can be found at
http://www.aat.gov.au/
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Attachment A
Frequently asked questions and answers
Q1: How is commercially sensitive material provided to NICNAS protected?
Commercially sensitive material provided to NICNAS is treated with the utmost
caution. Access to such material is restricted and is not disclosed by NICNAS without
the consent of the applicant. Please see the NICNAS website for more information.
Q2: What factors are considered by NICNAS when making a decision on an
exempt information application or a confidential listing application?
The statutory test requires that the decision maker must be satisfied (taking into
account all relevant information provided by the applicant and the objects of the
ICNA Act) that:
a. the applicant’s commercial interests would be prejudiced by the publication of
the information; and
b. the prejudice to the applicant’s commercial interests would be ‘substantial’;
and
c. the public interest in the publication of the information is outweighed by the
substantial prejudice to the applicant’s commercial interests.
Q3: What data or argument would satisfy the decision maker when applying the
statutory test?
Each application is different and is assessed on its own merits. NICNAS is not able to
specify the information required to satisfy the statutory test in every instance,
although unsubstantiated assertions are unlikely to allow the decision-maker to decide
in favour of the applicant. All relevant information and arguments will be considered,
and therefore applicants should not feel constrained in the data and argument they put
forward.
Q4: What is meant by the term ‘unsubstantiated assertions’?
An unsubstantiated assertion is a simple statement in support of a proposition without
reasoned argument or other evidence to justify the statement. For example, an
application accompanied only by the statement “We will suffer substantial prejudice
to our commercial interests if the chemical is listed in the non-confidential section of
the AICS, and this prejudice would outweigh any interest of the public in having the
chemical’s particulars published” is not sufficient.
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Q5: Can NICNAS provide examples of acceptable and unacceptable
applications?
Examples of hypothetical successful/non successful applications for both confidential
listing applications and exempt information applications are provided in Attachment
E. As all applications involve different considerations and are treated individually on
their merits, NICNAS is not able to provide examples that would illustrate every
situation.
Q6: What is the definition of ‘commercial interest’?
Commercial interest is not defined in the ICNA Act. Applicants may submit any
arguments supported by any available data to show its commercial interest could be
substantially prejudiced by NICNAS publishing commercially sensitive information
in assessment reports or listing the chemical on the non-confidential section of the
AICS.
Q7: What is ‘public interest’?
Public interest is not defined in the ICNA Act, but the objects of the ICNA Act imply
that there is a public interest in having details of chemicals published. Applicants may
submit any arguments supported by any available data to show that the substantial
prejudice to their commercial interests outweighs the public interest in listing the
chemical on the non-confidential section of the AICS or publishing commercially
sensitive information in assessment reports.
Q8: What are the objects of the ICNA Act?
The objects of the ICNA Act are to provide for:
a. a national system of notification and assessment of industrial chemicals for the
purposes of:
(i) aiding in the protection of the Australian people and the environment by
finding out the risks to occupational health and safety, to public health
and to the environment that could be associated with the importation,
manufacture or use of the chemicals; and
(ii)
providing information, and making recommendations, about the
chemicals to Commonwealth, State and Territory bodies with
responsibilities for regulating industrial chemicals; and
(iii) giving effect to Australia’s obligations under international agreements
relating to the regulation of chemicals; and
(iv) collecting statistics in relation to the chemicals;
being a system under which information about the properties and effects of the
chemicals is obtained from importers and manufacturers of the chemicals; and
b. national standards for cosmetics imported into, or manufactured in, Australia
and the enforcement of those standards.
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Q9: What is considered ‘relevant information’ when applying the statutory test?
Relevant information is information or material that rationally or reasonably relates to
the statutory test and its elements (the balance of commercial prejudice and public
interest). Relevant information would include evidence or reasoned argument
regarding the commercial implications of publication of information about the
chemical, or information about the chemical that is already in the public domain.
Q10: What is considered ‘irrelevant information’ when applying the statutory
test?
Irrelevant information is information that has no bearing on the application of the
statutory test in a particular circumstance, and could not be taken into account in
reaching a fair decision.
Q11: What types of information can be granted exemption from publication
(‘exempt information’)?
Exemption from publication means the information will not be included in publiclyavailable versions of the assessment report or in the Chemical Gazette. Common
examples of exempt information include the chemical name and CAS number, exact
function of the chemical in a product, and exact introduction volume. These details
are covered in the public reports by using the name by which the chemical is publicly
known (e.g. trade name), generic function of the chemical and a volume range or
upper limit.
NICNAS cannot exempt certain items of 'basic information' from publication— refer
to Q12 below.
Q12: What information is considered ‘basic information’ under the ICNA Act?
The ICNA Act defines basic information, in relation to a chemical, as:
a. the name or names by which the chemical is known to the public or is intended
by its importer or manufacturer to be known;
b. the chemical’s general uses;
c. the precautions and restrictions to be observed in the manufacture, handling,
storage, use and disposal of the chemical;
d. recommendations arising from the assessment of the chemical under [the
ICNA] Act that relate to disposing of the chemical and rendering it harmless;
e. the procedures to be following in the event of an emergency involving the
chemical;
f. prescribed physical and chemical data about the chemical, not being data that
would reveal the chemical’s composition;
g. prescribed data relating to the health effects or the environmental effects of the
chemical.
Prescribed data relevant to f. and g. above are specified in the schedules to the ICNA
Act (http://www.comlaw.gov.au/Details/C2013C00643/Html/Text#_Toc370725447).
16
Attachment B
The Australian Inventory of Chemical Substances
The Australian Inventory of Chemical Substances (AICS) is the legal device that
distinguishes new industrial chemicals from existing industrial chemicals in Australia.
All chemicals on the AICS are defined as existing industrial chemicals, while
industrial chemicals not included on AICS are defined as new industrial chemicals
that must be notified and/or assessed by NICNAS before they can be introduced (by
import or manufacture), unless exempt under the ICNA Act.
The AICS consists of a non-confidential section and a confidential section. The
current AICS lists approximately 40,000 non-confidential, and fewer than 100
confidential chemicals. Both sections include only the chemical name, Chemical
Abstracts Service Registry Number (CAS number) (or an AICS number in certain
circumstances), molecular formula and synonyms.
The non-confidential section of AICS is publicly available and can be searched
through the NICNAS website (www.nicnas.gov.au). The confidential section is kept
electronically in a secure form by NICNAS. Access to the confidential section of the
AICS is restricted to the Director of NICNAS and NICNAS staff who require access
to this information in carrying out their duties under the ICNA Act.
Exempt information
The ICNA Act allows applications to be made for information accompanying
different applications and provision of information, under other specified
circumstances to be treated as exempt information.
An application for exempt information can be submitted with:

Annual Reporting obligations;

Commercial evaluation permit applications or renewal applications;

Low volume chemical permit applications or renewal applications;

Controlled use permit applications or renewal applications;

Non-self-assessed and self-assessed assessment certificate applications, further
information supplied by the applicant and associated requests from the
Director for further information;

Extension of original assessment certificate applications;

Early introduction permit applications;
17

A statement of matters given to the Director under approved state and territory
notification procedures [Note, none currently in operation];

Particulars about a new industrial chemical where the chemical has been
notified and assessed under an Approved Foreign Scheme;

Information about the use and introduction of existing chemicals given to the
Director for decision on recommendation to declare a priority existing
chemical;

Information about a priority existing chemical;

Secondary notification applications.
A person can also apply for exempt information status for information supplied, or
information in a document produced, or information obtained because of the entry or
the exercise of powers of an inspector to monitor compliance with the ICNA Act.
Unlike confidential listing, there is no legislated requirement to re-apply for
information to be kept exempt from publication.
Confidential listing
New chemicals that have been assessed by NICNAS and for which an assessment
certificate has been issued (that is, standard, limited and polymer of low concern
notifications) are included on the AICS five years after the date that the assessment
certificate was issued. The initial five-year term is to prevent others from benefiting
from the costs the introducer has borne in complying with the NICNAS requirements.
At the end of five years, the holder of the assessment certificate (i.e. the ‘holder of the
confidence’) can apply to have the chemical listed in the confidential section
(subsection 14(1)). If no such application is made, or the application is refused, then
the chemical will be automatically listed on the non-confidential section (subject to
any available appeal).
A chemical is only permitted to remain in the confidential section for a five-year
period. At the end of each five-year period, a new application is required and a new
decision is taken as to whether or not it should remain for another five-year term (a
process known as re-listing). There is no limit to the number of times an introducer
can apply for re-listing, but the statutory test must be met on each occasion (taking
into account information relevant to the circumstances regarding the chemical at the
time of each application) for re-listing to occur.
18
Attachment C
APPLICATIONS FOR CONFIDENTIAL LISTING
NICNAS screens the application.
Has the applicant addressed the
different parts of the statutory
test?
NO
Give the applicant an
opportunity to correct any
deficiency in the application.
NO
Recommend the Director
refuses confidential listing.
NO
Recommend the Director
refuses confidential listing.
Y
E
S
Consider the application
Is there evidence the applicant has a
commercial interest?
Y
E
S
Has the applicant shown that their
commercial interest could
reasonably be substantially
prejudiced?
Y
E
S
Does the substantial prejudice to
commercial interests outweigh the
public interest* in publication?
Y
E
S
Recommend the Director
approves application.
NO
Recommend the Director
refuses confidential listing.
* A public interest regarding
chemicals is assumed as a
consequence of the legislative
test.
19
20
Attachment D
APPLICATIONS FOR EXEMPT INFORMATION
NICNAS screens the application.
Has the applicant addressed the
different parts of the statutory
test?
Y
E
S
Give the applicant an opportunity
to correct any deficiency in the
application.
Consider application
Is there evidence the applicant has
a commercial interest**?
Y
E
S
NO
NO
The Delegate refuses to exempt
particulars from publication.
Consider application
Has the applicant shown that its
commercial interest could
reasonably be prejudiced
substantially?
NO
The Delegate refuses to exempt
particulars from publication.
Y
E
S
Does the substantial prejudice to
commercial interests outweigh the
public interest* in publication?
NO
The Delegate refuses to exempt
particulars from publication.
Y
E
S
The Delegate approves exemption
of particulars from publication.
** A commercial interest regarding the chemical is assumed if the application accompanies a
notification of a new chemical.
*A public interest regarding chemicals is assumed as a consequence of the legislative test.
21
20
Attachment E
The examples below are presented in the format of the
internal decision document
Example of a hypothetical successful confidential listing application
Applicants should note that the figures for business dollar value and market share loss
provided in this example should not be taken to mean all applications which disclose
those exact or similar quantum losses will be successful.
Background
On XX January 2014 the applicant lodged an application under s 14(3) of
the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) to list
XXXX in the confidential section of the AICS. That application is accompanied by:
1.
2.
3.
4.
Form AICS-1 including responses to the questions on the form.
Search results of CAS number on the Chemlist database.
Search results of CAS number on Google.
MSDS for XXXXX.
Additional material considered in making a recommendation
1. New Chemicals assessment report number STD/0000 dated XX February
2009, including information exempted from publication.
Findings of fact
Based on the information submitted by the applicant and contained in the NICNAS
assessment report, the following findings of fact are made:
1. The chemical is a hardener for two-part epoxy resin.
2. The applicant advises that the chemical and/or products containing it are not
available to the public.
3. The applicant submits that the chemical use and estimated import volume have
not changed since the original application.
4. The chemical is classified as a dangerous good under the UN guidelines (UN
2735).
5. The applicant advised that the chemical has not been publicly identified on
overseas inventories.
6. The applicant advises that chemical has been granted confidential status under
the Toxic Substances Control Act (US EPA).
7. The applicant submits that the identity of the chemical is protected through
treating manufacturing instructions as commercial-in-confidence and with a
need-to-know basis. The chemical is not identified on the MSDS, technical
data sheet or other public documentation (commercial name is recorded).
8. The applicant advises that it would be difficult to reverse engineer the
chemical from the commercial product.
9. The applicant advises that the name of the commercial product appears in
some patents, but the notified chemical has not been described or covered by
any patents.
10. The applicant has estimated the loss of competitive advantage as >$5 million
if the chemical is listed on the public AICS, and provided a discussion of how
that figure was calculated.
21
11. The applicant advises its product holds 70% of the market in Australia for the
particular use.
12. The applicant estimates it could lose up to 60% of its market share if the
chemical’s details are made public, and provided a discussion of how that
figure was calculated.
13. The chemical is not considered to pose a risk to the environment based on its
reported use pattern.
14. There is moderate concern for occupational health and safety under the
conditions of the chemical’s occupational use.
15. There is negligible concern to public health based on the chemical’s reported
use pattern.
Consideration of the application
1. Has the applicant established a relevant commercial interest?
Yes √
No
Reasons
The company developed and introduced the chemical.
The company has put in place measures to protect the confidentiality of the
chemical’s identity.
The company’s product accounts for 70% of the Australian market in the
product category.
2. Has the applicant demonstrated that the publication of some or all of the
chemical’s particulars could reasonably be expected to prejudice substantially
the commercial interests of the applicant?
Yes √
No
Not applicable
Reasons
The applicant has estimated the loss of competitive advantage at >$5million
and described how they think a competitor will use the chemical’s identity to
the applicant’s disadvantage, which could result in a loss of up to 60% of
market share. The applicant provided a detailed discussion of its estimated
market share loss if the chemical’s particulars are published.
Does the prejudice to the applicant’s commercial interest outweigh the public
interest in disclosure of the chemical’s particulars?
Yes √
No
Not applicable
Reasons
The company has identified that the chemical’s use would reduce the need to
use product formulations that are high in volatile organic compounds, which is
of benefit to the public and the environment.
There is low public exposure to the chemical and, based on the use pattern
described, there is negligible concern about public health. The notified
chemical is not considered to pose a risk to the environment. The applicant has
advised that there has been no increase to the import volume of the chemical
and the release levels have not changed.
22
Example of a hypothetical unsuccessful confidential listing application
Applicants should note that the figures for business dollar value and market share loss
provided in this example should not be taken to mean all applications which disclose those
exact or similar quantum losses will be unsuccessful.
Background
On 00 January 2014 the applicant lodged an application under s 19(4) of the Industrial
Chemicals (Notification and Assessment) Act 1989 (the Act) to re-list XXXX in the
confidential section of the AICS. That application is accompanied by:
1.
2.
3.
4.
Form AICS-1 including responses to the questions on the form.
Copy of United States Patent number 0,000,000 dated 00 March, 1995.
Safety Data Sheet for XXXX dated 14/07/2011.
Product information brochure for XXXX.
Additional material considered in making a recommendation
1. New Chemicals assessment report number STD/0000 dated XX February 2004
including information exempted from publication.
Findings of fact
Based on the information submitted by the applicant and contained in the NICNAS
assessment report, the following findings of fact are made:
1. The chemical is used as a surfactant in detergent products for industrial use.
2. Originally the product was not sold to the general public, though the public could be
exposed as a result of accidental spillage during chemical transport. Since June last
year, the applicant has been marketing the detergent product to consumers as well as
industrial users.
3. The chemical is not classified as hazardous under the NOHSC Approved criteria for
classifying hazardous substances but is classified under the Globally harmonized
system for classification and labelling of chemicals as ‘Harmful to aquatic life with
long lasting effects’.
4. Based on the changed use-pattern, the chemical could pose a risk to the environment.
5. There is low concern for occupational health and safety under the conditions of the
chemical’s occupational use.
6. There is negligible concern to public health based on the chemical’s reported use
pattern.
7. The chemical has not been publicly identified on overseas inventories.
8. The applicant has in place significant measures to protect the identity and
manufacturing process of the chemical.
9. The chemical would be difficult to identify from analysis of the product in which it is
used (reverse engineer).
10. Manufacturing the chemical uses a unique proprietary process, making it difficult for
third parties to produce it.
11. The chemical is included in an active patent, but it is not identified in the patent.
12. The applicant values the global business in the chemical at a total of US $15 million.
13. The chemical is not manufactured in Australia.
14. The volume of the chemical introduced into Australia has decreased by 40% since the
chemical’s introduction.
23
15. The applicant will provide the chemical’s identity if requested by a medical
practitioner or a Poisons Information Centre.
Consideration of the application
3. Has the applicant established a relevant commercial interest?
Yes √
No
Reasons
The company developed and introduced the chemical.
The company has put in place measures to protect the confidentiality of the
chemical’s identity.
The company values its global business in the chemical at $US15 million.
4. Has the applicant demonstrated that the publication of some or all of the chemical’s
particulars could reasonably be expected to prejudice substantially the commercial
interests of the applicant?
Yes
No
√
Not applicable
Reasons
The applicant has estimated the value of the chemical to the business at US$15
million and states that releasing the chemical’s particulars would result in a
substantial loss of market share. The applicant did not provide any evidence to
support these assertions. No data on the estimated loss of market share nor data on
current market share were made available, so a consideration of loss of market share
compared with actual market share could not be made.
Although the applicant states that import volume into Australia has decreased, no data
are provided on whether globally sales have decreased, hence it cannot be determined
whether the decrease in Australia is indicative of a global decrease in sales or is
limited to Australia only. Noting the decline in import volume since the chemical was
first introduced, the uncertain quantum of commercial loss and the lack of data on
global sales, the applicant has not demonstrated that publication of some or all of the
chemical’s particulars could reasonably be expected to prejudice substantially its
commercial interests.
5. Does the prejudice to the applicant’s commercial interest outweigh the public interest
in disclosure of the chemical’s particulars?
Yes
No
Not applicable √
Reasons
The company has not satisfied the second arm of the statutory test therefore it is not
necessary to consider whether prejudice to the applicant’s commercial interest
outweigh the public interest in disclosure of the chemical’s particulars.
24
Example of a hypothetical successful exempt information application
Applicants should note that the figures for business dollar value and market share loss
provided in this example should not be taken to mean all applications which disclose
those exact or similar quantum losses will be successful.
Background
The notifier submitted an application for an assessment certificate under the Polymer
of Low Concern category, which was accompanied by an application for exempt
information. The data items requested to be treated as exempt information were the
chemical identity details (including the chemical name, CAS number, structural
formula and polymer constituents), as well as use details (specifically the
concentration of the notified polymer in the final product).
Additional material considered in making a recommendation
A Google search did not reveal a connection between the trade name and the chemical
identity of the polymer.
Findings of fact
Based on the information submitted by the applicant and that determined during the
NICNAS assessment process, the following findings of fact are made:
1. The chemical is used as an ingredient of coatings used in the industrial sector
only.
2. The applicant advises that the polymer and/or products containing it are not
available to the public.
3. The applicant advises that the polymer identity has not been revealed in other
jurisdictions where it has undergone new chemicals assessment, including US
and Canada.
4. The applicant submits that the identity of the polymer is protected through
treating manufacturing instructions as commercial-in-confidence and on a
need-to-know basis. The polymer is not identified on the MSDS, technical
data sheet or other public documentation (commercial name is recorded).
5. The applicant advises that it would be difficult to reverse engineer the polymer
from the commercial product.
6. The applicant advises that revealing the exact concentration would reveal
important formulation details to their competitors and has provided a nonconfidential concentration (as a limit value) which can be used in the public
report.
7. The applicant has estimated the loss of competitive advantage as $1.5 million
if the chemical identity is revealed in the public assessment report based on
their projected sales and market share.
8. The applicant has described how a competitor would use the identity of the
polymer to develop their own competing product, and thus reduce the market
share of the notifier before they can recover the substantial costs that were
invested into the R&D for this polymer (estimated at $500,000)
9. The polymer meets the PLC criteria and so is deemed to be low hazard. There
is therefore negligible concern for the environment and human health.
25
Consideration of the application
1. Has the applicant established a relevant commercial interest?
Yes √
No
Reasons
The company developed the polymer and intends to introduce under the
assessment certificate, if granted.
The company has put in place measures to protect the confidentiality of the
chemical’s identity.
2. Has the applicant demonstrated that the publication of some or all of the
chemical’s particulars could reasonably be expected to prejudice substantially
the commercial interests of the applicant?
Yes √
No
Not applicable
Reasons
The applicant has estimated the loss of competitive advantage at $1.5million
and described how they think a competitor will use the polymer’s identity to
the applicant’s disadvantage before the notifier can recoup some of the R&D
costs spent on the polymer (estimated at $500,000).
3. Does the prejudice to the applicant’s commercial interest outweigh the public
interest in disclosure of the chemical’s particulars?
Yes √
No
Not applicable
Reasons
The polymer meets the PLC criteria and is therefore considered to be low
hazard. The identified use is for the industrial sector only and so there will be
no public exposure.
26
Example of a hypothetical exempt information application with unsuccessful and
successful elements
Background
The notifier submitted an application for an assessment certificate under the Limited category
which was accompanied by an application for exempt information. The data items requested
to be treated as exempt information were the chemical identity details (including the chemical
name, CAS number, structural formula and molecular weight) and use details (the specific
concentration in the end-use formulations).
Additional material considered in making a recommendation
A Google search on the INCI name for the chemical (which is the name which must be on
product labels and is therefore ‘basic information’) revealed a number of sites in which the
CAS number (and therefore chemical identity) was disclosed.
Findings of fact
Based on the information submitted by the applicant and that determined during the NICNAS
assessment process, the following findings of fact are made:
1. The chemical is used as a cosmetics ingredient.
2. The notifier asserted that revealing the chemical identity in the NICNAS report is
detrimental as it is ‘CBI and thus should be protected’.
3. The notifier indicated that publishing the exact concentration in the public report
could reveal important formulation details to their competitors and then quantified the
money spent on developing the formulation.
4. The notifier provided a non-confidential value for the use concentrations that could be
used in the public report (<10%).
Consideration of the application
1. Has the applicant established a relevant commercial interest?
No for chemical ID, Yes for use details
Reasons
The company has not established a relevant commercial interest in protection of the
chemical identity as the identity of the chemical is already in the public domain and
connected with the INCI name (which is required to be on the consumer product
label). No further consideration is required for the decision regarding chemical
identity and the application for these data items will be rejected.
The company has established a commercial interest in keeping the use details exempt
from publication as they have developed the formulation and have kept the exact use
concentrations confidential.
2. Has the applicant demonstrated that the publication of some or all of the chemical’s
particulars could reasonably be expected to prejudice substantially the commercial
interests of the applicant?
Yes √
No
Not applicable
Reasons
For the use details the notifier has demonstrated that the publication of the exact
concentration in the end use products could cause substantial prejudice by describing
the link between the publication of the information and use by competitors, and then
estimating the amount spent on developing the formulation which would be lost if the
27
competitor was able to reproduce the formulation without having to expend this
money.
3. Does the prejudice to the applicant’s commercial interest outweigh the public interest
in disclosure of the chemical’s particulars?
Yes √
No
Not applicable
Reason
The notifier provided a non-confidential value to be used in the published risk
assessment, which reveals the maximum concentration the chemical could be in the
products and therefore the public interest in disclosure of the exact concentration in
the formulation is diminished.
28
Example of a hypothetical exempt information application requiring further
justification
Background
The notifier submitted an application for an assessment certificate under the Standard
category which was accompanied by an application for exempt information. The data items
requested to be treated as exempt information were the chemical identity details (including
the chemical name, CAS number, structural formula and molecular weight).
Additional material considered in making a recommendation
A Google search on the published name for the chemical did not reveal a link to the chemical
identity of the notified chemical.
Findings of fact
Based on the information submitted by the applicant and contained in the NICNAS
assessment report, the following findings of fact are made:
1. The chemical is used in household and industrial cleaners.
2. The chemical is classified as hazardous for acute toxicity, corrosivity and ecotoxicity.
3. The notifier asserts that the company has ‘spent a lot on R&D and revealing the
chemical identity would give our competitors knowledge of the chemical’.
4. The notifier described the agreements in place with its customers to protect
confidentiality.
Consideration of the application
1. Has the applicant established a relevant commercial interest?
Yes √
No
Reasons
The company has developed the chemical and intends to introduce the chemical under
the assessment certificate, if granted. The notifier has described the measures taken to
protect the confidentiality of the chemical identity.
2. Has the applicant demonstrated that the publication of some or all of the chemical’s
particulars could reasonably be expected to prejudice substantially the commercial
interests of the applicant?
Yes
No
√
Not applicable
Reasons
The notifier has only provided an unsupported assertion that the company ‘has spent a
lot on R&D and revealing the chemical identity would give our competitors
knowledge of the chemical’. Without further evidence (such as quantitative
information or reasoned argument) to back this up the delegate cannot determine
whether the prejudice arising from publishing the chemical identity information will
be substantial.
In this case the notifier will be asked at the time of screening the assessment to
provide further justification before a decision is made.
3. Does the prejudice to the applicant’s commercial interest outweigh the public interest
in disclosure of the chemical’s particulars?
Yes
No
Not applicable √
Reasons
A decision for this arm of the statutory test cannot be made until further details are
provided by the notifier. However there is a public interest in the publication of the
29
chemical identity details given that the chemical will be used in household cleaners
and has hazardous properties to both human health and the environment.
30