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

July 2016

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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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BackgroundIn 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 non-confidential 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 guidelinesThese 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 Non-self-assessed and self-assessed assessment certificate applications, further

information supplied by the applicant and associated requests from the Director for further information.

1 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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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

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.

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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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;

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.

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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:

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.

(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?

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(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 criteriaThe 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 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).

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Applicants need to be aware of the matters of most concern to the general public. These include (but are not limited to):

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:

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.

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.

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(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.

(j) How environmental, public and workers’ health and safety could be compromised by the chemical’s inclusion on the confidential section of AICS.

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(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).

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;

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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 applicationExempt 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 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.

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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. Where a chemical’s particulars are listed on the confidential section of the AICS, or where information is exempt from publication, the ICNA Act prohibits disclosure by NICNAS officers except in the circumstances set out in the ICNA Act. For example, in both instances a NICNAS officer may disclose the information ‘in the course of carrying out duties or functions’ under the ICNA Act. 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 publicly-available 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).

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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 informationThe 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;

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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 listingNew 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.

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Attachment C

APPLICATIONS FOR CONFIDENTIAL LISTING

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Consider the application

Recommend the Director approves application.

YES

YES

YES

YES

NO

NO

NO

NO

Recommend the Director refuses confidential listing.

Does the substantial prejudice to commercial interests outweigh the

public interest* in publication?

Recommend the Director refuses confidential listing.

Has the applicant shown that their commercial interest could

reasonably be substantially prejudiced?

Recommend the Director refuses confidential listing.

Is there evidence the applicant has a commercial interest?

Give the applicant an opportunity to correct any

deficiency in the application.

NICNAS screens the application. Has the applicant addressed the

different parts of the statutory test?

* A public interest regarding chemicals is assumed as a consequence of the legislative test.

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Attachment D

APPLICATIONS FOR EXEMPT INFORMATION

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Consider application

** 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

Consider application

NOThe Delegate refuses to exempt

particulars from publication.

YES

Is there evidence the applicant has a commercial interest**?

YES

YES

YES

NO

NO

NO

The Delegate approves exemption of particulars from publication.

The Delegate refuses to exempt particulars from publication.

Does the substantial prejudice to commercial interests outweigh the

public interest* in publication?

The Delegate refuses to exempt particulars from publication.Has the applicant shown that its

commercial interest could reasonably be prejudiced

substantially?

Give the applicant an opportunity to correct any deficiency in the

application.

NICNAS screens the application. Has the applicant addressed the

different parts of the statutory test?

Attachment E

The examples below are presented in the format of the internal decision document

Example of a hypothetical successful confidential listing applicationApplicants 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.

BackgroundOn 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. Form AICS-1 including responses to the questions on the form.2. Search results of CAS number on the Chemlist database.3. Search results of CAS number on Google.4. MSDS for XXXXX.

Additional material considered in making a recommendation1. New Chemicals assessment report number STD/0000 dated XX February

2009, including information exempted from publication.

Findings of factBased 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.

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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 application1. Has the applicant established a relevant commercial interest?

Yes √ NoReasonsThe 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 applicableReasonsThe 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 applicableReasonsThe 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.

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Example of a hypothetical unsuccessful confidential listing applicationApplicants 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.

BackgroundOn 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. Form AICS-1 including responses to the questions on the form.2. Copy of United States Patent number 0,000,000 dated 00 March, 1995.3. Safety Data Sheet for XXXX dated 14/07/2011.4. Product information brochure for XXXX.

Additional material considered in making a recommendation1. New Chemicals assessment report number STD/0000 dated XX February 2004

including information exempted from publication.

Findings of factBased 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.

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15. The applicant will provide the chemical’s identity if requested by a medical practitioner or a Poisons Information Centre.

Consideration of the application3. Has the applicant established a relevant commercial interest?

Yes √ NoReasonsThe 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 applicableReasonsThe 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 √ReasonsThe 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.

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Example of a hypothetical successful exempt information applicationApplicants 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.

BackgroundThe 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 recommendationA Google search did not reveal a connection between the trade name and the chemical identity of the polymer.

Findings of factBased 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 non-confidential 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.

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Consideration of the application1. Has the applicant established a relevant commercial interest?

Yes √ NoReasonsThe 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 applicableReasonsThe 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 applicableReasonsThe 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.

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Example of a hypothetical exempt information application with unsuccessful and successful elements

BackgroundThe 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 recommendationA 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 factBased 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 application1. Has the applicant established a relevant commercial interest?

No for chemical ID, Yes for use detailsReasonsThe 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 applicableReasonsFor 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

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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 applicableReasonThe 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.

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Example of a hypothetical exempt information application requiring further justification

BackgroundThe 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 recommendationA Google search on the published name for the chemical did not reveal a link to the chemical identity of the notified chemical.

Findings of factBased 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 application1. Has the applicant established a relevant commercial interest?

Yes √ NoReasonsThe 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 applicableReasonsThe 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 √ReasonsA 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

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chemical identity details given that the chemical will be used in household cleaners and has hazardous properties to both human health and the environment.

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