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Statutory Test

This AICIS guidance is for anyone who is applying for protection of their confidential business information (CBI) and members of the public who wish to know more about how we apply the 'statutory test'

We use a statutory test to decide on applications for protection of CBI. If we grant protection of CBI, we won't publish certain commercially sensitive information about the introduction. Before we grant CBI protection, we also look at the public interest in full information about the introduction being published.

Commercial interest and commercial prejudice

For your CBI application to succeed, you must be able to prove to us that:

  • You have a commercial interest and it’s reasonable to expect that if we publish certain information, your commercial interests could be substantially prejudiced (harmed)
  • This commercial prejudice outweighs the public interest in having access to this information

Addressing the statutory test in your application

We make decisions on a case by case basis. You should submit whatever reasons and data you have and any other evidence you think is relevant.

Mandatory aspects of the test you must address

The following 2 elements are mandatory:

  1. Proof that you have a commercial interest
  2. The degree of prejudice to your commercial interests if the information was disclosed

If you do not address the mandatory aspects of statutory test

If you have not provided the information we need to allow us to consider your application, we'll notify you. You'll have at least 20 working days to provide us the information we request - if don't respond / contact us, we'll consider your application to have been withdrawn.

Other aspects you can address (public interest) (optional)

You don't need to address the public interest aspect of the test as we look at this. But, if you have information you feel is relevant, you can provide it. For example, if you can provide us with information you believe shows prejudice to your commercial interests outweighs public interest.

Example of where you're unlikely to prove commercial prejudice

If there's public information already available about chemical

A scenario here is if you apply for protection of your chemical's molecular or structural formula, but not the chemical name.

We do a public search for the chemical by its name after we receive your application and our search reveals details about the chemical's molecular and structural formula. Because we've found information about your chemical that you've asked to protect, your application is weakened and unlikely to succeed.

In these circumstances, you have not shown to us that your business will experience commercial prejudice if we publish formulae details about your chemical.

Commercial interest (unlisted chemicals)

If you apply for an assessment certificate or a commercial evaluation authorisation, we're likely to consider that you have a commercial interest if the information is not already publicly available. Your next step will be to to provide evidence to us about the prejudice to your commercial interest.  We'll then weigh this evidence against the public interest in publication.

Commercial interest (listed chemicals)

If a chemical is already listed, you'll have to demonstrate that you have a continuing commercial interest. We cannot assume you still have a commercial interest in confidentiality. This is relevant if you are applying for any of the following:

  • to vary an Inventory listing
  • to continue your CBI protection
  • a confidential Inventory listing (if your chemical was assessed by NICNAS (before 1 July 2020))

Ways you can demonstrate commercial interest / substantial prejudice in your application

  • Describe the pathway from publication of the information to commercial loss, such as through loss of competitive advantage, intellectual property, or product and/or corporate viability.
  • Describe and estimate commercial damage that would occur to your business in Australia and/or globally if we publish the information.·
  • Describe and estimate the potential damage to the future commercial use of the chemical. For example, next generation technology).

Examples of demonstrating substantial prejudice to commercial interest

The following is provided as a guide only. It's not exhaustive and will not be relevant to every situation

1. How will you experience commercial loss if we disclose the chemical identity / information?

Estimate the loss if possible and consider factors such as:

  • Immediate and longer-term losses and
  • The potential for commercial loss at a local and international level.

You could support this estimation by giving us information such as:

  • Modelling and statement of assumptions about the commercial impact from publishing the information. This could include:
    • an estimation of the decrease in dollar value and/or market share of sales of the chemical if the information is published and
    • an explanation of how you estimated the decrease
  • Data estimating the actual or expected market share of sales of the chemical
  • Projected figures on the chemical's commercial interest and market value. This could be 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
  • Describe the role of the chemical as part of new technology that has not (at the time of application) reached its full commercial potential.

2. Has the chemical been publicly identified in a chemical inventory of another country?

If yes, 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 the fact that information is published elsewhere.

3. Does the substance already have confidential status in a chemical inventory of another country? (based on commercial interests)

If yes, provide details.

4. Has confidential listing in any jurisdiction been sought and denied?

If yes, provide the reasons if available to you.

5. What measures has the owner taken to protect the confidential nature of the information?  (including in manufacturing and importing the substance?

How is the information protected within the company? Are details of the chemical subject to non-disclosure agreements?

6. Has the substance been identified other than by trade or generic names in journals, books or other public sources?

If yes, give us the information that supports why we should grant confidential status in Australia, to protect your commercial interests.

7. Has the substance and/or its use been patented?

You should provide copies of any patents relevant to the use of the chemical in Australia. Comment on how the failure to grant confidential status will harm your commercial interests. For example, you could highlight where the coverage of the patents do not disclose the identity of the substance, the manufacturing process, or the use/application of the chemical.

As long as you have provided adequate justification, the existence of a patent does not prevent granting the application. This is as long as patent does not specifically reveal the chemical name (or it cannot be obtained from the patent).

But, your case for confidential listing may be weakened where a patent discloses enough detail to bring the chemical identity into the public domain.

You should state what the patent discloses. You should discuss why publication of a chemical’s details, or listing on the non-confidential Inventory, provides information that is not otherwise available.

8. Is the substance's name required to be on a Safety Data Sheet (SDS)?

Provide a copy of any relevant SDS. The existence of an SDS that discloses the chemical name does not mean we can't approve your application. But you will need to provide adequate justification. There are examples where access to the SDS may be restricted and the chemical’s identity is not known publicly. For example where a chemical’s SDS is only available to commercial clients who have signed a non-disclosure agreement.

Public interest

While there's no statutory definition of “public interest” that we rely on, the objects of our legislation are taken to define the public interest. One of these objects is to protect human and health and the environment. One way we do this is by publishing information about industrial chemicals.

You can submit any arguments that you believe support your application such as:

  • Information that you believe shows that you have:
    • Substantial prejudice to your commercial interests that
    • Outweigh public interest in publishing

Things you should consider

The matters of public interest can include (but are not limited to):

  • Whether a chemical is hazardous
  • How much is known of the toxicity and ecotoxicity of the chemical
  • Whether there is wide consumer use
  • Whether there is potential human or environmental exposure to the chemical and/or its degradation products
  • Whether the chemical is taken up by living organisms (persistent and/or bio-accumulative)

You should provide all relevant information that you have.

You do not need to do more chemical testing or provide more test reports (unless we ask for this to address information gaps). If you provide monitoring data with a confidential listing application, it will assist us when we assess hazardous chemicals. This includes those of international concern (such as potential endocrine disrupters).

How you can address public interest (not mandatory)

If you are applying for continued CBI protection or confidential Inventory listing, you should check if the AICIS chemical assessment report has recommendations for future monitoring or testing. If testing has been performed, you should include the outcomes in your application.

How to address public interest - examples

The is a guide only. It is not exhaustive, and will not be relevant to every situation.

  1. The likelihood of any beneficial impacts from use of the chemical - this may include replacing chemicals or processes harmful to human health and the environment, with less harmful ones.
  2. The potential impact on innovation in Australia or available to Australians.
  3. The public availability of data in literature, media, internet or other published sources - this includes data from other countries about the properties, fate or effects of the chemical substance.
  4. Short and long term exposure patterns for workers, the public and the environment in manufacturing, use, transport and disposal of the chemical. Exposure patterns will be used to consider the risks posed by hazardous substances. If you are applying for a new confidential listing, you don't need to reproduce exposure scenarios. This applies we've already considered them when we did a new chemical assessment. But you do need to describe new exposure scenarios that NICNAS may not have assessed. Information on special or new technological controls to reduce exposure. For example include, containment facilities, special training for workers, or special packaging). You may also need to mention situations likely to increase exposure This could be, for example casual or contract workers are used. Here you'll need to explain how you'll put in place risk controls for these workers. Risk controls might include: - communicating information on chemical hazards -  exposure controls and worker training) are being implemented to minimise exposure could be included.
  5. The type of information available to the Australian public on the chemical. For example are there product sheets and brochures for the chemical and associated products or on the operations of the chemical industry sites that handle the chemical substance.
  6. Information on adverse incident reporting methods available to all workers to alert employers to any problems with the chemical.
  7. 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.
  8. Results from monitoring studies for the chemical, by-products, degradation products, or wastes. Where relevant, what is their level of compliance with State and Territory standards and licences? You may strengthen your case if you provide monitoring data on the fate of the chemical and on the its effects on human health and the environment.
  9. Whether Australian Commonwealth, State or Territory laws require the disclosure of the chemical identity. For example: -hazardous substances regulations -  poisons scheduling, - environmental regulations, - the National Pollutant Inventory etc.
  10. Whether there could be compromise to environmental, public and workers’ health and safety through inclusion of the chemical on the confidential section of the Inventory.
  11. Has the applicant made provided enough information to allow tracking of a substance? ,This includes residues, metabolites and/or degradation products, in the environment.
  12. Whether a safety data sheet (SDS) is available to workers and the public.

Public interest test - consultation with risk managers

The public interest test takes into account the hazards of (and potential exposure to) the chemical. For chemicals with a higher hazard and/or exposure, the public interest in accessing information may be greater. This test also allows us to consider the need for risk managers to impose controls so the chemical can be safely used - where a risk manager must disclose information publicly about a chemical to manage risk. In these circumstances, the public interest in such disclosure is more likely to outweigh your commercial interests.

We will consult with sector risk managers on the need for specific elements of disclosure necessary for effective risk management.

 

 

 

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