Consultation Paper 5

Last update 22 March 2018

Contents

  1. Executive Summary
  2. Part 1: About the NICNAS reforms
  3. Part 2: Development of reforms implementation detail
  4. Part 3: Categorisation of chemical introductions
    1. 3.1 Key features of the categories for unlisted introductions
    2. 3.2 How to categorise unlisted chemical introductions
    3. 3.3 Previous consultation on categorisation criteria
    4. 3.4 Criteria to determine the human health introduction category
    5. 3.5 Criteria to determine the environment category
    6. 3.6 Criteria for categorisation as Reported using the international pathway
  5. Part 4: Information requirements for categorisation and assessment of unlisted chemical introductions
    1. 4.1 Exempted introductions
    2. 4.2 Reported introductions
    3. 4.3 Assessed introductions
  6. Part 5: Categorising an unlisted chemical introduction – hazard information requirements
    1. 5.2 Information requirements to determine the human health introduction category
    2. 5.3 Information requirements to determine the environment introduction category
  7. Part 6: Specified chemical introductions - additional requirements
  8. Part 7: Regulatory treatment of unlisted chemicals introduced at the nanoscale
    1. 7.1 Proposal for regulatory treatment of nanoscale chemicals
    2. 7.2 Background on regulatory treatment of nanoscale chemicals
  9. Part 8: Commercial evaluation authorisation
  10. Part 9: Ban on the use of new animal test data for cosmetic ingredients
  11. Part 10: Other matters
  12. Attachment A: Introductions of chemicals that are comparable to listed chemicals
  13. Attachment B: Polymer of low concern criteria
  14. Attachment C: Persistent Bioaccumulative and Toxic substances criteria
  15. Abbreviated terms
  16. Defined terms

Executive Summary

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Read this paper in conjunction with Consultation Paper 5 supporting material

The Australian Government has decided to reform the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to:

  • make regulatory effort more proportionate to risk
  • promote safer innovation by encouraging the introduction of lower risk chemicals
  • continue to protect the Australian people (both workers and the public) and the environment from any harmful effects of industrial chemicals.

We have published 4 previous consultation papers over the past 2 years, and have received a considerable amount of feedback from stakeholders.

The consultation process has helped us develop advice for Government on the best way to implement the reforms. The result is the introduction of legislation to Parliament to establish a new scheme called the Australian Industrial Chemicals Introduction Scheme (AICIS).

The legislation is principles-based. It will establish a new legal framework for the regulation of industrial chemicals in Australia. Much of the technical detail supporting the new framework will be in delegated legislation. This will allow flexibility to adapt to scientific and regulatory developments.

Through Consultation Paper 5, we seek feedback on matters to go into the delegated legislation.

Mostly, these are technical matters. They relate in particular to the categorisation and assessment of unlisted chemical introductions. That is, the introduction of industrial chemicals not included on the Australian Inventory of Industrial Chemicals (the Inventory).

This paper is detailed because we wish to present the new scheme in a transparent way. Not all stakeholders will need to engage in the level of technical detail presented in this paper.

The technical matters in this paper (and the companion Supporting Material) take into account:

  • the latest international developments in chemical risk assessment and regulatory science
  • the need to implement a practicable scheme that is proportionate in the requirements it sets.

Figure 1 illustrates how the parts of this paper relate to the new scheme’s categorisation and assessment process.

Part 1 gives context about this consultation. It is a general overview of the NICNAS reforms, announced in May 2015 by the Australian Government.

Part 2 talks about consultation to date on the implementation of the reforms. It focuses on the development of the technical detail to be set out in the delegated legislation and guidance material. Our Response to feedback on technical details, which accompanies Consultation Paper 5, provides more detail about how we have used the feedback that we have received.

Part 3 describes the objective hazard and exposure criteria. These criteria will provide a structured and transparent approach to self-categorisation of industrial chemical introductions. The chemical categorisation outcomes (Exempted, Reported or Assessed) will allow risk-based regulation. Because of this, we will be able to focus our regulatory efforts on higher risk chemicals.

Part 4 describes the requirements for information that:

  • an introducer must consider in categorising their chemical introduction
  • we will need as part of an assessment certificate application.

Part 5 provides the detail of the hazard information required to categorise chemical introductions the right way for both human health and environmental risks. The level of hazard characterisation required will vary with the predicted level of exposure.

Part 6 describes additional information requirements. These will apply for a limited set of specified chemical introductions where minimum information requirements will not be enough to determine the indicative risk, and thus the appropriate introduction category.

Read more about the information requirements framework in our Supporting Material, which accompanies Consultation Paper 5. It includes guidance on the hazard information that will be sufficient for categorisation. It takes into account the latest scientific developments, including in vitro tests and in silico modelling and the more traditional toxicological data derived from tests using animals.

Part 7 is a proposal for the categorisation of industrial chemicals introduced at the nano-scale. It presents options for the properties of nano-scale chemicals that should be used as criteria to define the chemicals that require pre-introduction assessment.

Part 8 describes the criteria for the commercial evaluation authorisation pathway that will be prescribed in the delegated legislation. It will include the volume threshold and the circumstances related to public exposure. It also talks about the information requirements for this pathway.

Part 9 presents the details to be included in the delegated legislation to implement the national ban on the use of new animal test data for chemicals used exclusively as cosmetic ingredients.

Part 10 discusses other matters to be included in the delegated legislation including:

  • prescribed bodies for consultation
  • prescribed bodies for disclosure of confidential business information (CBI)
  • definitions to be elaborated on in the delegated legislation (including article and industrial chemical)
  • requirements for the annual compliance declaration.

We are seeking your feedback on the proposed implementation detail in this paper.

We will consider your feedback. After this, we will draft the delegated legislation. Consultation on the delegated legislation should occur in the second half of 2017.

Figure 1 - Relationship between sections of this consultation paper and the categorisation process

This flowchart is in the Executive summary of NICNAS Consultation Paper 5. It shows how parts of the paper relate to the new scheme's categorisation and assessment process.


Next - About the NICNAS reforms

Part 1: About the NICNAS reforms

Download Consultation Paper 5 [PDF 2.8 MB]

Go to the start of Consultation Paper 5

Read Consultation Paper 5 supporting material

The Australian Government has decided to reform the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to:

  • make regulatory effort more proportionate to risk
  • promote safer innovation by encouraging the introduction of lower risk chemicals
  • continue to protect the Australian people (both workers and the public) and the environment from any harmful effects of industrial chemicals.

As part of the 2015-16 Budget, the Australian Government announced a range of reforms to the regulation of industrial chemicals. The goal is that the assessment effort would better reflect the risks posed by industrial chemicals, while maintaining Australia’s robust health and safety standards. The reforms would include:

  • rebalancing pre-and post-introduction regulatory requirements to match the indicative risk profile of a new chemical
  • streamlining the current risk assessment process for new and existing industrial chemicals
  • greater use of international assessment materials
  • more appropriate monitoring and compliance tools.

An important benefit of re-directing regulatory effort towards chemicals with a higher risk profile is that there will be reduced costs to businesses and consumers using lower risk chemicals. Industry utilising Exempted and Reported introduction categories will benefit from reduced direct costs (i.e. no notification fees) and reductions in the time taken to introduce the chemicals to market (i.e. no imposed assessment time frame), when compared to the current scheme.

The faster regulatory pathway to introduce lower risk chemicals is an incentive to introduce safer new industrial chemicals, including replacing more hazardous existing chemicals. Although there will be less emphasis on pre-introduction assessment of lower risk new chemicals, more focus on post-introduction assessment and monitoring will help maintain the protection of health and safety of the public, workers and the environment.

Because of the reforms, the number of industrial chemicals subject to a pre-introduction assessment by us is expected to decrease by over 70%, with pre-introduction assessments dropping from around 3% of all new chemicals to 0.3%.

The reforms also improve protections for the public, workers, and the environment from higher risk chemicals by giving us the ability to impose conditions of introduction on higher risk chemicals. If risk managers cannot manage an identified risk, the Executive Director could refuse to allow introduction of the chemical or stop its introduction. Improved monitoring and compliance powers will help us better identify and manage non-compliance to maintain current levels of health and environmental protection.


Next - Development of reforms implementation detail

Part 2: Development of reforms implementation detail

Download Consultation Paper 5 [PDF 2.8 MB]

Go to the start of Consultation Paper 5

Read Consultation Paper 5 supporting material

Since September 2015, there has been extensive consultation with stakeholders to develop the implementation detail for the reforms. Figure 2 shows the stakeholder consultation process to date (note ‘CP’ refers to Consultation Paper). We have previously released an implementation plan and 4 consultation papers, held public workshops and reviewed written submissions.

There has been a high level of engagement throughout the consultation process to date.

We have received 148 submissions and consulted with almost 200 organisations.

We have held 8 public workshops. We organised these to give industry, community and regulatory stakeholders the opportunity to engage with the details of the proposed regulatory framework. Over 350 stakeholders attended.

The fourth in this series of consultation papers (Consultation Paper 4) summarised the overall approach to implementation of the reforms and outlined the proposed overarching framework for the reforms to be set out in new legislation.

The focus of Consultation Paper 4 was therefore on the primary legislation. It did not cover the technical detail that will be in the delegated legislation.

Some of this detail was included in previous consultation papers, at the request of stakeholders, so they could understand how the regulatory framework would operate in its entirety. For example, Consultation Papers 1 to 3 described the indicative criteria for hazard and exposure bands for categorising chemicals for health and environmental risks, and Consultation Paper 3 proposed an approach to the categorisation of polymers. It is proposed that this level of detail (e.g. technical details relating to hazard and exposure bands) will be fully described in delegated legislation and supporting guidance material.

This approach:

  • is consistent with good regulatory practice
  • enables adjustments to more readily be made to the categorisation of chemical introductions (and the data required to support categorisation) as new information comes to light about determining the risks of those chemicals
  • allows the legislative framework establishing the new scheme to be flexible and adaptable to future regulatory and chemical developments.

While there will still be Parliamentary scrutiny of the delegated legislation, this approach allows the scheme to remain responsive, risk-based and risk-proportionate over time.

The purpose of this fifth consultation paper (Consultation Paper 5) is to seek stakeholder feedback on matters to be included in delegated legislation. Consultation Paper 5 takes into account feedback on the technical details already provided in response to Consultation Papers 1-3. Our ‘Response to stakeholders on technical details’ document accompanies this paper. It provides more detail about stakeholder feedback. It also provides details about what feedback we have and have not been able to incorporate so far.

In developing the technical details presented in this paper (and in the Supporting Material that accompanies it), we have taken into account:

  • the latest developments in chemical risk assessment and regulatory science, including the newer types of information now available to characterise the hazards of chemicals (such as in vitro tests and in silico modelling)
  • the latest knowledge on the chemical classes and chemical properties that are of concern to human health and the environment
  • the need for a practicable scheme that facilitates compliance
  • the need to be proportionate in the requirements we set for industry

We will review the feedback we receive on this paper and use it to develop our advice to the Australian Government on the delegated legislation. Like the approach taken in the drafting of previous consultation papers, some details that will only be included in guidance and not in delegated legislation have also been included in this suite of papers (mainly in the Supporting Material). This is to give stakeholders a sense of how the framework would work in its entirety.

Table 1 shows the breakdown of the topics to be included in delegated legislation or guidance material (including a characterisation guide, which will be referenced in the delegated legislation).

Other aspects of the reformed scheme are not included in this paper, because they will not be prescribed in the delegated legislation. These include evaluations initiated by AICIS and the details of how the new confidential business information protections will work (e.g. AICIS Approved Chemical Names). We will consult on these aspects later in 2017.

Table 1 Breakdown of topics to be included in delegated legislation or guidance material
Delegated legislation (as set out in Consultation Paper 5)Characterisation Guide and guidance documents
(as set out in supporting material)
  • Categorisation criteria for unlisted chemical introductions
  • Certain definitions
  • CEA criteria – elaboration of public exposure and volume threshold criteria
  • Categorisation criteria for chemicals introduced at the nanoscale
  • Information requirements for categorisation and assessment (high-level):
    • Chemical identity
    • Physico-chemical information
    • Hazard & fate information
    • Introduction/use/exposure details
  • PLC criteria
  • International pathway criteria
  • Definition of specified chemical introductions (for which additional information requirements will apply)
  • Prescribed bodies for consultation
  • Prescribed bodies for disclosure of CBI
  • Required content of annual declarations
  • PBT criteria
  • Specifics of the hazard information considered sufficient to meet the requirements for categorisation
    • Types of information
    • Information sources
  • Information waivers
    • Hazard endpoints
    • Non-hazard endpoints
  • Release factors
  • Suitable analogue criteria/definition
  • Additional information requirements for specified chemical introductions

Figure 2 Stakeholder consultation to date

Figure 2 stakeholder consultation to date Consultation Paper 5


Next - Part 3: Categorisation of chemical introductions

Part 3: Categorisation of chemical introductions

Download Consultation Paper 5 [PDF 2.8 MB]

Go to the start of Consultation Paper 5

Read Consultation Paper 5 supporting material

The following links take you to the various parts of this section.

The primary legislation will describe the regulatory requirements for the introduction of industrial chemicals. This includes that any introductions must meet the requirements of one of the following categories:

  • listed introductions (the chemical is listed on the Inventory and introduction is within the terms of the listing (if any))
  • Exempted introductions (very low risk)
  • Reported introductions (low risk)
  • Assessed introductions (medium to high risk)
  • commercial evaluation introductions
  • exceptional circumstances introductions (Ministerial authorisation to allow urgent introduction to protect public health or the environment).

This means that, for each chemical you introduce, you should first check to see if the chemical is listed on the Inventory and, if so, whether your proposed introduction is within the terms of this listing. If you are introducing chemicals in a mixture1, then each chemical should be checked separately.

If the chemical is not listed on the Inventory (or the introduction is outside of the terms of the listing), it should be further categorised. The delegated legislation will describe the criteria and information needed to categorise an unlisted chemical introduction. In other words, it sets out how to determine if the unlisted chemical is Exempted, Reported or Assessed.

We provide details about the hazard and exposure criteria used for categorisation. This presents the framework in a transparent way.

Part 8 describes commercial evaluation authorisations. Exceptional circumstances introductions are not discussed further in this paper, as there is no need to prescribe any elements of these authorisations in the delegated legislation.

1 We will develop guidance to help introducers determine if what they are introducing is a UVCB (which is categorised as a single chemical) or a mixture.


Next - Part 4: Information requirements for categorisation and assessment of unlisted chemical introductions

3.1 Key features of the categories for unlisted introductions

Go back to the start Part 3 Categorisation of chemical introductions

Some key features of the Exempted, Reported and Assessed introduction categories are included in Table 2.

Table 2 - Key features of the Exempted, Reported and Assessed chemical introduction categories

Exempted introductions

Reported introductions

Assessed introductions

Indicative risk

Very low risk

Low risk

Medium to high risk

Pathway to Inventory inclusion

No - Chemicals will not be included on the Inventory

No - Chemicals will not be included on the Inventory

Yes - Chemicals will be ultimately included on the Inventory

Level of interaction with AICIS

No pre-introduction interaction with AICIS

Must be reported to AICIS prior to introduction

Must be assessed by AICIS prior to introduction

Record keeping and/or information requirements

Record keeping requirements

Record keeping requirements and specified information submitted as part of report to AICIS

Specified information must be submitted to AICIS

Details published

Identifying information on introduced chemicals not published

Limited information on specified chemical introductions published (e.g. introductions via the International pathway)

Assessment statement published and linked to later Inventory listing

Continuing obligations

Annual declaration of whether chemicals have been introduced in this category

Annual declaration that the chemical introduction still meets the criteria for this category

Post-assessment information obligations

Monitoring by AICIS

Post-introduction monitoring

Post-introduction monitoring

Post-introduction monitoring

For commercial or other reasons (for example, wanting an eventual listing of the chemical on the Inventory), introducers may apply for an assessment certificate for chemical introductions meeting Exempted or Reported criteria.


Next - Section 3.2: How to categorise unlisted chemical introductions

3.2 How to categorise unlisted chemical introductions

Go back to the start Part 3 Categorisation of chemical introductions

This section describes the steps to follow to determine the introduction category for a chemical not listed on the Inventory. Later sections of this paper provide detailed descriptions of the human health and environmental criteria for each introduction category. Please note that, throughout this paper, ‘chemical’ refers to both chemicals and polymers, unless otherwise stated.

To categorise an unlisted chemical introduction, an introducer must first determine if it is of a type that delegated legislation explicitly requires to be in a particular category (Exempted, Reported or Assessed), and/or excluded from categorisation in a particular category. Examples include:

  • chemical introductions via the international pathway can be categorised as Reported (see section 3.6 for further details on this pathway)
  • introductions of chemicals at the nanoscale will be categorised as Assessed, except under specific circumstances (see Part 7 for further details)
  • introductions of chemicals that are identified in international conventions, that Australia has ratified (such as the Stockholm Convention), will be categorised as Assessed, if their introduction is not prohibited or restricted
  • introductions of chemicals comparable to chemicals on the Inventory (including polymers meeting a modified version of the “2% rule”) will be categorised as Exempted (see Attachment A for further details)
  • introductions of chemicals that meet the (internationally harmonised) criteria for Polymers of Low Concern will be categorised as Exempted, except under specific circumstances. (Refer to Attachment B for PLC criteria details, including proposed changes).

If the unlisted chemical introduction is not allocated by delegated legislation to a particular category, then categorisation based on the indicative risk is undertaken. This takes into account both exposure and hazard characteristics (as represented in the risk matrices). This requires determining the introduction category for both:

  • human health risks
  • environmental risks.

Step 1: Determine the human health introduction category

To determine the human health introduction category, introducers must identify the:

  • Exposure Band for human health
  • health hazards relevant to that Exposure Band.

This information gives the human health introduction category.

Step 2: Determine the environment introduction category

To determine the environment introduction category, an introducer must identify the:

  • Exposure Band for the environment
  • environmental hazards relevant to that Exposure Band.

This information gives the environment introduction category.

Step 3: Determine the chemical introduction category

If the human health and environment introduction categories are the same, then the chemical introduction category is also the same.

If the human health and environment introduction categories are different, the chemical introduction category is the higher of the two. Table 3 details the outcomes.

Table 3 - Categorisation outcomes for unlisted chemical introductions

Table 3 - Categorisation outcomes for unlisted chemical introductionsWe will develop online tools prior to commencement of the new scheme to assist introducers to determine the correct introduction category.


Next - Section 3.3: Previous consultation on categorisation criteria

3.3 Previous consultation on categorisation criteria

Go back to the start Part 3 Categorisation of chemical introductions

Earlier consultation papers for the NICNAS reforms described indicative criteria for the hazard and exposure bands for health and the environment.

We received a range of stakeholder feedback about the categorisation criteria and matrices in response to Consultation Papers 1-4. Following this feedback, further internal review of the risk-based categorisation framework has occurred.

The criteria in the following sections are the result of these considerations. They incorporate suggestions from stakeholders where these resulted in regulatory outcomes that are:

  1. risk-based
  2. proportionate, and
  3. protective of workers, public health and the environment.

Some of these refinements of the regulatory treatment, particularly for low volume chemical introductions, have resulted in added exposure bands. Whilst this does increase the size of the visual representations (the risk matrices), there will only be one added option for the introducer to consider, and it may result in reduced regulatory burden for a significant number of introductions.


Next - Section 3.4: Criteria to determine the human health introduction category

3.4 Criteria to determine the human health introduction category

Go back to the start Part 3 Categorisation of chemical introductions

Determining the Exposure Band for human health

The criteria to allow the relevant Exposure Band for human health to be determined are in Table 4. The introduction volume to be used when determining the Exposure Band for your introduction is the total introduction volume across all end uses. If at least one of your end uses results in intentional human exposure then the criteria applicable to  that use type applies to the total introduction volume. Definitions of key terms are included in the Defined terms section (and/or in the text below the table).

Table 4 - Criteria for human health Exposure Bands

Exposure Band

Criteria for human health Exposure Bands

Use type

Chemicals with end uses that will not result in intentional human exposure

Chemicals with end uses that will result in intentional human exposure

1

or

  • Contained import/export.

2

  • Introduction volume ≤10 kg per annum.
  • Introduction volume ≤10 kg per annum and end use concentration ≤0.1%.

3

or

  • introduction volume >10 and ≤1,000 kg per annum

or

  • introduced and used at a concentration ≤1%.
  • Introduction volume >10 and ≤100 kg per annum

or

  • introduced and used at a concentration ≤1%.

4

  • Introduction volume >1,000 and ≤10,000 kg per annum.
  • Introduction volume >100 and ≤1,000 kg per annum.

5

  • Does not meet the criteria for human health exposure bands 1, 2, 3 or 4.
  • Does not meet the criteria for human health exposure bands 1, 2, 3 or 4.

2 Research and development does not include introduction of a chemical that is made available to the public on its own, in combination with other chemicals or in an article. At the point of research and development (e.g. on cosmetic formulations), the chemical introduction is considered to have an end use that will not result in intentional human exposure.

There have been three key changes to the Exposure Band criteria since Consultation Paper 3.

Firstly, there was a change in exposure-type terminology to include end uses that will and will not result in “intentional human exposure”. This recognises that cosmetics are not the only chemicals associated with intentional exposure to the public.

“Intentional human exposure”, with respect to the end use of industrial chemicals, is defined as deliberate placement of an industrial chemical or a product containing one directly in contact with any part of the human body due to its intended end use. This includes end use in cosmetics, electronic cigarettes (e-cigarettes) and tattoo inks.

Intentional human exposure will not include exposures that are incidental to the end use, including exposure to household cleaning products and chemicals used to adjust the pH in swimming pools.

There will be some overlap in the extent of exposure expected from chemical uses that are and are not considered to meet the definition of intentional human exposure (for example, some rinse-off cosmetic uses versus some household cleaning product uses). While the inclusion of broader use types in the definition was largely based on the general expected exposure level, it was also done for practicality and compliance reasons.

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Secondly, a low volume threshold exposure band (Exposure Band 2) was added to provide a risk-proportionate reduction in the regulatory burden for chemicals (except those of highest concern) introduced at very low volumes (<10 kg/annum).

For chemicals introduced at this very low volume with end uses resulting in intentional human exposure, there is an additional requirement to have an end use concentration of 0.1% or less. This is because effects associated with some hazards (such as skin sensitisation and toxicity from repeated exposure) can occur even at very low concentrations. When introduced at low volumes, relevant hazard characterisation information on chemicals may be unavailable. Thus, the combined volume and concentration limit aims to minimise the risks to the public from the use of these chemicals in which they are directly applied to the body.

Thirdly, the research and development criteria have been refined for chemical introductions, particularly those at >100 kg per annum. This is to minimise worker exposure to the chemicals (consistent with scenarios in lower Exposure Bands), while maintaining opportunities for chemical industry innovation. We define research and development in the Defined terms section at the end of this paper. The revised definition (compared to the one in Consultation Paper 3) reflects the refinements to the criteria and the assumptions (e.g. with respect to the level of public exposure) consistent with the Exposure Band characterisation.

Research and development activities for chemicals introduced at volumes >100 kg per annum will be limited to a single user/business entity. We will permit experimentation and/or analysis at multiple sites (in different geographical locations), if the same user/business entity operates all of them and the sites are identified. We will permit small-scale off-site analytical testing (e.g. NMR analysis of samples).

Hazard Bands for human health

The Hazard Bands showing the possible hazard characteristics of chemicals for human health (including uncertainties with respect to hazards for human health) are in Table 5. Some of the criteria included in the table relate to chemicals (i.e. both chemicals and polymers), and others relate only to high molecular weight polymers.

Hazard Band D includes hazard characteristics of highest concern to human health and characteristics with highest uncertainty with respect to concern to, or effects on, human health. We defined hazard criteria so that classification under the GHS will meet the criteria for that health effect. How the introducer demonstrates hazard characteristics will vary depending on the Exposure Band (see Part 4 for further details), so that the information requirements are commensurate with the anticipated level of exposure.

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Table 5 - Criteria for human health Hazard Bands

Hazard Band

Criteria for human health hazard characteristics

Classifications under the GHS that will meet the criteria for the Hazard Band

D

Any of the following:

  • carcinogenicity (chemicals that may cause cancer or are suspected of causing cancer)
  • mutagenicity/genotoxicity (chemicals that may cause genetic defects or are suspected of causing genetic defects)
  • reproductive and developmental toxicity (chemicals that may damage or that are suspected of damaging fertility or the unborn child, or chemicals that may cause harm breast-fed children)
  • chemicals with adverse effects known to be mediated by an endocrine disruption mode of action
  • chemicals that contain a sequence of ≥4 and ≤20 fully fluorinated carbon atoms.
  • carcinogenicity (category 1 and 2)
  • mutagenicity (category 1 and 2)
  • toxic to reproduction (category 1 and 2)
  • effects on or via lactation

C

Any of the following:

  • acute toxicity (chemicals that are fatal or toxic by any exposure route)
  • specific target organ toxicity (chemicals that cause damage to organs by any route  following single exposure or that cause or may cause damage to organs by any route through prolonged or repeated exposure)
  • skin corrosion or eye damage (chemicals that cause severe skin burns and eye damage or serious eye damage)
  • skin or respiratory sensitisation (chemicals that may cause an allergic skin reaction  or that may cause allergy or asthma symptoms or breathing difficulties if inhaled)
  • respiratory corrosion
  • high molecular weight polymer water absorbing if NAMW > 10,000 Da
  • high molecular weight polymers with reactive functional groups if:
    • NAMW ≥1,000 and <10,000 Da and
    • ≥5% low MW oligomeric species <1,000 Da or ≥2% low MW oligomeric species <500 Da and
    • combined FGEW <1,000 (moderate concern groups only) or combined FGEW <5,000 (high concern and moderate concern groups)
  • high molecular weight polymers containing elements of concern (i.e. that fail the chemical composition criterion for PLCs) and have NAMW ≥1,000 and <10,000 Da
  • acute toxicity (category 1, 2 and 3)
  • specific target organ toxicity – repeated exposure (category 1 and 2)
  • specific target organ toxicity – single exposure (category 1)
  • respiratory sensitisation (category 1)
  • skin sensitisation (category 1)
  • skin corrosion (category 1)
  • eye damage (category 1)
  • non-GHS statements: toxic by eye contact (AUH070) and corrosive to the respiratory tract (AUH071)

B

Any of the following:

  • acute toxicity (chemicals that are harmful by any exposure route)
  • specific target organ toxicity (chemicals that may cause damage to organs by any route following single exposure, or may cause respiratory irritation or drowsiness or dizziness)
  • skin or eye irritation (chemicals that cause skin irritation or serious eye irritation)
  • aspiration hazard (chemicals that may be fatal if swallowed and enters airways)
  • high molecular weight polymers with NAMW >70,000 Da if the:
    • polymer is insoluble in water and
    • polymer is intended to be used in aerosol cosmetics.
  • high molecular weight polymers that are not PLCs (and do not meet the criteria for Hazard Bands C and D)
  • chemicals that contain a sequence of ≤3 or ≥21 fully fluorinated carbon atoms.
  • specific target organ toxicity – single exposure (category 2 and 3)
  • eye irritation (category 2A)
  • skin irritation (category 2)
  • aspiration hazard (category 1)

A

  • chemicals that do not meet the criteria for Hazard Bands B–D.
-

There are 4 key changes to the Hazard Band criteria since Consultation Paper 3.

We removed nanomaterials from Hazard Band D (see Part 7 for further details).

Secondly, text has been included to reflect some non-GHS hazard statements that are applicable in Australia.

Thirdly, we omitted physical hazards from Hazard Band B. We will consider associated physical hazards when assessing a chemical. However, the presence of a physical hazard will not be a basis for determining the chemical introduction category. This takes into account other legislated obligations of introducers with respect to the introduction and transport of chemicals with associated physical-chemical hazards.

Fourthly, the categorisation outcomes for polymers and chemicals with sequences of fully fluorinated carbon atoms were refined (which involved changes to the Hazard Band criteria). See Part 6 for further details. Chemicals and polymers with fully fluorinated segments have known human health concerns. This is particularly the case for longer fluorinated chain lengths. This is the reason for the placement in Hazard Band D of chain lengths between 4 and 20. Shorter chain lengths may also present some concerns. This is the reason for their placement in Hazard Band B (together with very long chain lengths that present less of a concern). These changes ensure that chemicals and polymers containing fluorinated chains of any length are Reported or Assessed, rather than Exempted.

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Determining the introduction category for human health

The combination of Exposure Band and health hazards gives the human health introduction category. Figure 3 outlines the way exposure and hazard bands interact to determine the relevant introduction category for human health:

Figure 3 - Determining the introduction category for human health using the Hazard Band and Exposure Band

Figure 3 - Determining the introduction category for human health using the Hazard Band and Exposure Band

If a chemical introduction is in Exposure Band 1 for human health, its chemical introduction category is Exempted for human health irrespective of its hazard characteristics.

If a chemical introduction is in Exposure Band 2 for human health, its chemical introduction category will be:

  • Exempted for human health if the chemical does not have the hazard characteristics described in Hazard Band D or
  • Assessed for human health, in all other circumstances.

If a chemical introduction is in Exposure Band 3 for human health, the chemical introduction category will be:

  • Exempted for human health if the chemical does not have the hazard characteristics described in Hazard Band B, C or D or
  • Reported for human health if the chemical does not have the hazard characteristics described in Hazard Band D or
  • Assessed for human health in all other circumstances.

If a chemical introduction is in Exposure Band 4 or 5 for human health, the chemical introduction category will be:

  • Exempted for human health if the chemical does not have the hazard characteristics described in Hazard Band B, C or D or
  • Reported for human health if the chemical does not have the hazard characteristics described in Hazard Band C or D or
  • Assessed for human health in all other circumstances.

While the regulatory outcomes for Exposure Bands 4 and 5 are the same, the information requirements to characterise the hazards for these two exposure bands are different (see Part 5 for further details).

Table 6 - Determining the introduction category for human health

Introduction category for human health

Exposure Band
(Health)

Restrictions on hazard characteristics

Exempted for human health

Exposure Band 1

Not applicable – the introduction will be Exempted irrespective of any known hazards of the chemical.

Exposure Band 2

Chemical must not have any of the hazard characteristics in Hazard Band D.

Exposure Band 3-5

Chemical must not have any of the hazard characteristics in Hazard Bands B-D.

Reported for human health

Exposure Band 3

Chemical must not have any of the hazard characteristics in Hazard Band D.

Exposure Band 4-5

Chemical must not have any of the hazard characteristics in Hazard Band C or D.

Assessed for human health

Exposure Band 2-5

Not applicable – this is the default category if the chemical introduction cannot be categorised as Exempted or Reported.


Next - Section 3.5: Criteria to determine the environment category

3.5 Criteria to determine the environment category

Go back to the start of Part 3 Categorisation of chemical introductions

This part discusses:

Determining the Exposure Band for environment

The criteria to enable the relevant Exposure Band for environment to be determined are in Table 7. Definitions of key terms are included in our Defined terms section (and/or in the text below the table).
Table 7 - Criteria for environment Exposure Bands

Exposure Band

Criteria for environment Exposure Bands

1

2

  • Treated release volume ≤10 kg per annum.

3

  • Treated release volume >10 kg and ≤100 kg per   annum.

4

  • Treated release volume >100 kg and ≤1,000 kg   per annum.

5

  • Treated release volume >1,000 kg and ≤10,000   kg per annum.

6

  • Does not meet the criteria for environmental   Exposure Bands 1, 2, 3, 4 or 5.

3 Research and development does not include where release of hazardous chemicals to landfill or sewer occurs prior to treatment to render them no longer hazardous.

In contrast to the criteria for human exposure (largely related to introduction volume), the criteria for the environment exposure largely relates to the treated release volume.

Treated release volume means the maximum volume of chemical expected to be released to the environment during the specified period:

  • following some form of treatment and/or
  • where treatment is not required because the chemical is released to the air in a dispersive manner from:
    • small-scale, consumer uses, including (but not limited to) aerosols
    • end use of volatile substances, where the release is incidental.

Treatment means some form of intervention (including capture, destruction, irreversible transformation or disposal to landfill) to minimise release of a chemical into the environment.

The treated release volume is estimated as a percentage of the maximum introduction volume expected to be released. It relies on the use of release factors. Further discussion on our approach to developing default release factors, for use when determining the Exposure Band for environment, is included in the Consultation Paper 5 Supporting Material.

Release without treatment would fall into the highest Exposure Band. Examples of appropriate treatment of chemicals and releases without treatment are provided in Table 8.

Table 8 - Examples of treatment and releases without treatment

Examples of treatment

Examples of release without treatment

  • Capture and treatment of industrial   effluent or air emissions through a licensed trade waste facility or at an   onsite treatment facility
  • Treatment of industrial solid waste at a   licensed treatment facility
  • Incineration or irreversible transformation   of industrial effluent or air emissions at an onsite treatment facility
  • Disposal of domestic and commercial solid   waste to landfill
  • Combustion of fuels
  • Disposal to sewer
  • Irreversible binding of a chemical within   an inert matrix, such as concrete, UV/EB-cured inks or stable plastic/polymer articles.
  • Disposal of industrial wastes to the ocean   following offshore use, or to a natural waterway or body of water following   onshore use
  • Intentional industrial scale release of a   chemical to the environment during use, where release is not minimised by   engineering controls.

There are 3 key changes to the Exposure Band criteria since Consultation Paper 3.

Firstly, there was a change in terminology to refer to ‘treated release volume’, which is more explicit and allows for dispersive releases to air (which are untreated, but not of concern) to be captured in lower Exposure Bands.

Secondly, a low volume threshold exposure band (Exposure Band 2) was added to decrease the regulatory burden associated with introduced chemicals (excluding those of highest concern) with very low treated release volumes (≤10 kg/annum).

Thirdly, the ‘irreversibly bound within an inert matrix’ criterion in Exposure Band 5 was removed. Chemicals bound within an inert matrix will be considered in the development of default environmental release factors. Thus, the introductions of such chemicals should be categorised similarly to other introduced chemicals.

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Hazard Bands for environment

The Hazard Bands depicting the possible hazard characteristics of chemicals for environment (and/or uncertainties with respect to hazards for environment) are in Table 9. Hazard Band E includes hazard characteristics of highest concern to the environment and characteristics with greatest uncertainty with respect to concern to or effects on, the environment. How the introducer demonstrates hazard characteristics will vary depending on the Exposure Band (the information requirements will vary based on the anticipated release to the environment; see Part 5 for further details).

Table 9 - Criteria for environment Hazard Bands

Hazard Band

Criteria for Environment Hazard Characteristics

Classifications under the GHS that will meet the criteria for the Hazard Band

E

Any of the following:

N/A

D

Any of the following:

  • very toxic to any aquatic life (chemicals that are very toxic to aquatic life or very toxic to aquatic life with long lasting effects)
  • chemicals that are Persistent and Bioaccumulative (PB), but not Toxic
  • chemicals that contain a sequence of ≤3 or ≥21 fully fluorinated carbon atoms
  • acute aquatic toxicity (Category 1)
  • chronic aquatic toxicity (Category 1)

C

  • toxic to any aquatic life (chemicals that are toxic to aquatic life or toxic to aquatic life with long lasting effects)
  • acute aquatic toxicity (Category 2)
  • chronic aquatic toxicity (Category 2)

B

Any of the following:

  • harmful to any aquatic life (chemicals (including polymers) that are harmful to aquatic life or harmful to aquatic   life with long lasting effects or that may cause long lasting harmful effects   to aquatic life)
  • chemicals (including polymers) that have bioaccumulation potential
  • chemicals (excluding polymers) that do not have ready biodegradability only
  • chemicals (including polymers) that contain copper, nickel, zinc, silver, chromium, or aluminium.
  • Polymers that:
    • have an overall cationic charge at pH 4-9 or
    • are not stable (excluding biopolymers).
  • acute aquatic toxicity (Category 3)
  • chronic aquatic toxicity (Category 3 and 4)
A
  • Chemicals that do not meet the criteria for Hazard bands B-E.
-

4 See Attachment C for national PBT criteria and/or Defined terms for further details on criteria. Note that while based on the GHS toxicity criteria, the term ‘Toxic’ in this instance relates to a specific threshold used for the purposes of defining PBT in Australia.

The PBT criteria in the delegated legislation will align with the national PBT criteria as set out in Attachment C – Persistent bioaccumulative and toxic substances (PBT) Criteria.

There are 4 key changes to the Hazard Band criteria since Consultation Paper 3:

  1. we removed nanomaterials from Hazard Band E (see Part 7 for further details)
  2. we added synthetic greenhouse gas chemicals to Hazard Band E
  3. we refined the Hazard Band B criteria for polymers and inorganic chemicals
  4. we refined and clarified the categorisation outcomes for polymers and chemicals containing sequences of fully fluorinated carbon atoms (which involved changes to the Hazard Band criteria). See Part 6 for further details.

Chemicals and polymers with fully fluorinated segments have the potential to degrade to chemicals that may be persistent in the environment, may bioaccumulate, and may be highly toxic. Longer fluorinated chain lengths are of greater concern. This is the reason for the placement in Hazard Band E of chain lengths between 4 and 20. Shorter chain lengths may also present some concerns. This is the reason for their placement in Hazard Band D (together with very long chain lengths that present less of a concern). These changes ensure that chemicals and polymers containing fluorinated chains of any length are Reported or Assessed, rather than Exempted.

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Determining the introduction category for environment

The combination of Exposure Band and environment hazards gives the environment introduction category. Figure 4 outlines the way exposure and hazard bands interact to determine the relevant introduction category for environment:

Figure 4 - Determining the introduction category for environment using the Hazard Band and Exposure Band

Figure 4 Determining the introduction category for environment using the Hazard Band and Exposure Band

If a chemical introduction is in Exposure Band 1 for environment, the chemical introduction category will be Exempted for environment. This is irrespective of the hazard characteristics of the chemical.

If a chemical introduction is in Exposure Band 2 for environment, the chemical introduction category will be:

  • Exempted for environment if the chemical does not have the hazard characteristics described in Hazard Band D or E or
  • Reported for environment if the chemical does not have the hazard characteristics described in Hazard Band E
  • Assessed for environment in all other circumstances.

If a chemical introduction is in Exposure Band 3 or 4 for environment, the chemical introduction category will be:

  • Exempted for environment if the chemical does not have the hazard characteristics described in Hazard Band C, D or E or
  • Reported for environment if the chemical does not have the hazard characteristics described in Hazard Band E or
  • Assessed for environment in all other circumstances.

If a chemical introduction is in Exposure Band 5 for environment, the chemical introduction category will be:

  • Exempted for environment if the chemical does not have the hazard characteristics described in Hazard Band B, C, D or E or
  • Reported for environment if the chemical does not have the hazard characteristics described in Hazard Band D or E or
  • Assessed for environment in all other circumstances.

If a chemical introduction is in Exposure Band 6 for environment, the chemical introduction category will be:

  • Exempted for environment if the chemical does not have the hazard characteristics described in Hazard Band B, C, D or E or
  • Reported for environment if the chemical does not have the hazard characteristics described in Hazard Band C, D or E or
  • Assessed for environment in all other circumstances.

Note that while the regulatory outcomes for Exposure Bands 3 and 4 are the same, the information requirements to characterise the hazards for these two exposure bands are different (see Part 5 for further details).

Table 10 presents an alternate way to consider the above, focusing on the category outcome.

Table 10 - Determining the introduction category for environment

Introduction category for environment

Exposure Band
(Environment)

Chemical must not have the following hazard characteristics

Exempted for environment

Exposure Band 1

Not applicable – the introduction will be Exempted irrespective of any known hazards of the chemical.

Exposure Band 2

Chemical must not have any of the hazard characteristics in Hazard Bands D-E.

Exposure Band 3-4

Chemical must not have any of the hazard characteristics in Hazard Bands C-E.

Exposure Band 5-6

Chemical must not have any of the hazard characteristics in Hazard Bands B-E.

Reported for environment

Exposure Band 2-4

Chemical must not have any of the hazard characteristics in Hazard Band E.

Exposure Band 5

Chemical must not have any of the hazard characteristics in Hazard Bands D-E.

Exposure Band 6

Chemical must not have any of the hazard characteristics in Hazard Bands C-E.

Assessed for environment

Exposure Band 2-6

Not applicable – this is the default category if the chemical introduction cannot be categorised as Exempted or Reported.


Next - Section 3.6: Criteria for categorisation as Reported using international pathways

3.6 Criteria for categorisation as Reported using the international pathway

Go back to the start Part 3 Categorisation of chemical introductions

Reported chemical introductions can include the introduction of potentially higher risk chemicals (that would otherwise be categorised as Assessed) using the international pathway. Such chemicals must have had a risk assessment or evaluation undertaken by, or in association with, a trusted prescribed international body (refer to the following section). There are also further criteria relating to the risk assessment and its outcomes, as detailed below.

Trusted prescribed international bodies for the international pathway

Table 11 lists the trusted prescribed international bodies. These bodies have been assessed as meeting the Health portfolio regulators criteria for the adoption of international standards and risk assessments5 (i.e. the criteria to be a trusted prescribed international body for the international pathway). They will be prescribed in delegated legislation.

Table 11 - Trusted prescribed international bodies

Assessment type

Relevant international body

New Substance assessments under the Canadian Environmental Protection Act, 1999 (CEPA, 1999).

Environment and Climate Change Canada/Health Canada

Opinions from the European Scientific Committee on Consumer Safety (SCCS) that have then been taken up in the Annexes of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.

European Scientific Committee on Consumer Safety

Risk assessments done by an EU Member State Authority or ECHA that:

  • are in accordance with the Regulation (EC)   No 1907/2006 of the European Parliament and of the Council of 18   December 2006 on the Registration, Evaluation, Authorisation and Restriction   of Chemicals (REACH), and
  • are then reviewed by the ECHA Risk Assessment   Committee (in the context of restrictions under the REACH Regulation).

An EU Member State Authority or ECHA, as reviewed by the ECHA Risk Assessment Committee.

Risk assessments done by applicants for authorisation that:

  • are in accordance with the Regulation (EC)   No 1907/2006 of the European Parliament and of the Council of 18   December 2006 on the Registration, Evaluation, Authorisation and Restriction   of Chemicals (REACH),and
  • are then reviewed by the ECHA Risk Assessment   Committee (in the context of authorisation under the REACH Regulation).

An applicant for authorisation in accordance with REACH Regulation, as reviewed by the ECHA Risk Assessment Committee.

New chemicals assessments (for which Australia has been involved as a secondary jurisdiction in an international parallel process) undertaken under either the

  • Canadian Environmental Protection Act, 1999   (CEPA, 1999) or
  • the United States Toxic Substances Control Act,  1976 (TSCA, 1976) as amended by the Frank R. Lautenberg Chemical Safety for   the 21st Century Act, 2016

Environment and Climate Change Canada/Health Canada

United States Environmental Protection Agency

5 http://www.health.gov.au/internet/main/publishing.nsf/Content/RPF-International-stds

Additional international bodies may be added to the delegated legislation later if they meet the criteria to be a trusted prescribed international body for the international pathway.

Stakeholder feedback from previous consultation papers suggested other international bodies that could be trusted prescribed bodies for the international pathway. At this time, no other international bodies meet the relevant criteria.

The acceptability of assessments undertaken through the Frank R. Lautenberg Chemical Safety for the 21st Century Act (i.e. the amended Toxic Substances Control Act of the US EPA) for the international pathway is uncertain at this time. This is because it is still early in the implementation of these amendments and there have been relatively few assessments undertaken and published. We will consider this further after we know more about the implementation of the amended US legislation and the assessments being undertaken under it. Note that parallel process assessments are the exception to this, as mentioned in Table 11.

Further requirements for use of the international pathway

For use of this pathway, the international risk assessment/evaluation performed by a trusted international prescribed body must:

  • take into account both hazard and exposure, and the chemical must have been assessed for both health and environmental risks (not necessarily by the same trusted international prescribed body) unless
    • the international risk assessment is for human health risks only, and the chemical is categorised as Exempted or Reported for environment
    • the international risk assessment is for environmental risks only, and the chemical is categorised as Exempted or Reported for human health.
  • be for the same end use as the proposed chemical introduction into Australia
  • be for the same or higher introduction volume compared  to the proposed chemical introduction into Australia
  • be for the same or higher use concentration compared to the proposed chemical introduction into Australia.

The risk of introduction into Australia must be no higher than that identified in the overseas jurisdiction. This must take into account:

  • the risk assessment assumptions applied by the international regulator and the relevance to the Australian context
  • any risk management conditions from the international risk assessment that must be able to be met in Australia
  • any information that has become available since the overseas assessment/approval.

The international pathway does not provide a route to listing on the Inventory. This is consistent with the fact that other chemicals in this category (Reported chemical introductions) will not be entered on the Inventory.

We would review the information reported by introducers in reliance on the international pathway and, if necessary, make recommendations to risk managers.

If we determine that the criteria have not been met, and the chemical introduction properly requires assessment, the introducer would need to comply with the requirements of the Assessed category in order to continue to introduce the chemical.


Next - Part 4: Information requirements for categorisation and assessment of unlisted chemicals

Part 4: Information requirements for categorisation and assessment of unlisted chemical introductions

Download Consultation Paper 5 [PDF 2.8 MB]

Go to the start of Consultation Paper 5

Read Consultation Paper 5 supporting material

The following links take you to the various parts of this section:

The delegated legislation will outline information needed by introducers to categorise their chemical. It will also explain record-keeping and documentation requirements for introducers as well as information that is needed to apply for an assessment certificate or commercial evaluation authorisation.

This information may include:

  • chemical identity information
  • physico-chemical properties
  • hazard and fate information
  • introduction/use/exposure information.

Introducers will need to keep records to demonstrate that they have identified and categorised all chemical introductions.

For unlisted chemical introductions, introducer information requirements will depend on the indicative risk of the chemical introduction. Information needs will vary according to Exposure Band or type of introduction within an introduction category (e.g. Exempted introduction of a polymer of low concern (PLC), or Reported introduction under the international pathway). Part 5 describes the hazard information requirements and Part 6 explains the extra information needed for chemical introductions with increased levels of concern.


Next - Part 5: Categorising an unlisted chemical introduction - hazard information requirements

4.1 Exempted introductions

Go back to the start of Part 4 Information requirements for categorisation and assessment of unlisted chemicals

Exempted introductions do not need pre-introduction reporting or assessment. The introducer must still maintain and provide records, on request, for an introduced chemical’s identity and the basis on which the categorisation was determined (i.e. information on the exposure and hazard characterisation).

Chemical identity

Required information related to chemical identity:

  • proper chemical name, i.e. CAS name and/or IUPAC name
  • CAS registry number (if available)
  • common or trade name (if available)
  • synonyms (if available), and
  • as complete a description as possible if the chemical is a UVCB (e.g. CAS description, details of the immediate precursors/natural sources).

If your chemical is a polymer, in addition to the above, you will also need:

  • identity of all polymer constituents that are present at >2% (by weight) prior to polymerisation
  • molecular weight distribution of the polymer:
  • polydispersity index (WAMW/NAMW)
  • the percentage of low molecular weight oligomeric species:
    • below 1,000 Daltons, and
    • below 500 Daltons.

Exposure characterisation

Required information related to exposure characterisation:

  • the Exposure Bands for human health and the environment
  • annual introduction volume
  • use of the chemical (including end-uses and likely end-of-life disposal pathways)
  • calculated release volume.

Hazard characterisation

Required information related to the hazard characterisation:

  • the minimum information requirements for categorisation (as applicable for the Exposure Band) and
  • the additional information used to categorise as Exempted (if applicable).

Next - Section 4.2: Reported introductions

4.2 Reported introductions

Go back to the start of Part 4 Information requirements for categorisation and assessment of unlisted chemicals

As with Exempted introductions, introducers must maintain and be able to provide records of the chemical identity of the introduced chemical and be able to support the categorisation decision (i.e. have information on the exposure and hazard characterisation).

Introducers will also have to submit information via the online portal before they introduce the chemical. A third party can do this if the information is confidential from the introducer.

Information submitted prior to introduction will aid in targeted post-introduction monitoring efforts. As there will be a reduction in pre-introduction assessments by us (of lower risk chemical introductions), there will be more post-introduction monitoring to ensure human health and environmental protections are maintained.

The report submitted to us prior to introduction will include the following items.

Chemical identity

Required information related to chemical identity:

  • proper chemical name, i.e. CAS name and/or IUPAC name
  • CAS registry number (if available)
  • common or trade name (if available)
  • synonyms (if available)
  • as complete a description as possible if the chemical is a UVCB (e.g. CAS description, details of the immediate precursors/natural sources)

If your chemical is a polymer, in addition to the above, you will also need:

  • identity of all polymer constituents that are present at >2% (by weight) prior to polymerisation
  • molecular weight distribution of the polymer:
  • the percentage of low molecular weight oligomeric species:
    • below 1,000 Daltons, and
    • below 500 Daltons.

Identification of the type of Reported introduction

Introducers would select from a list such as:

  • chemical introduction categorised as Reported based on the relevant Exposure and Hazard Band criteria
  • chemical introduction categorised as Exempted but chosen by introducer to report
  • introduction via the international pathway of a chemical otherwise categorised as an Assessed introduction.

Exposure characterisation of the chemical introduction

Required information related to exposure characterisation:

  • the Exposure Bands for human health and the environment
  • volume:
    • annual introduction volume (within defined bands)
    • release volume (using default release factors)
  • concentration – maximum introduction and end use concentrations (within defined bands)
  • end use (using high-level use descriptors)
  • confirmation that any relevant Exposure Band criteria are met (tick-box style; e.g. treatment prior to release, criteria related to research and development).

Hazard characterisation of the chemical

Required information related to the hazard characterisation:

  • the Hazard Bands of the chemical for human health and the environment
  • the known hazard classification
  • confirmation that the minimum information requirements for categorisation (if applicable for the Exposure Band) have been met
  • if the applicable Hazard Band was based on structural considerations (e.g. chemicals that contain a sequence of ≤3 or ≥21 fully fluorinated carbon atoms) and/or uncertainties associated with the hazard characteristics.

International pathway information

  • The name of the trusted international prescribed body that undertook the assessment/evaluation
  • the scope of the assessment/evaluation (including use, volume and concentration)
  • confirmation that the risk of introduction into Australia is no higher than that identified in the overseas jurisdiction, taking into account the risk assessment assumptions applied by the international regulator
  • the date of the assessment
  • the assessment reference and permission from the original overseas notifier to allow us access to any unpublished assessment reports held by the overseas body
  • information about any conditions recommended as part of the assessment or that formed part of any subsequent regulatory approval by the relevant body, and a statement describing how those conditions would be met by the introducer in Australia
  • confirmation the introducer is not aware of any new information, since the international assessment/approval, that adversely affects the hazard profile of the chemical.

Next - Section 4.3: Assessed introductions

4.3 Assessed introductions

Go back to the start of Part 4 Information requirements for categorisation and assessment of unlisted chemicals

For Assessed introductions, introducers must submit information to us for a risk assessment and be given an assessment certificate before introducing a chemical. Third parties can submit information if it is confidential from the introducer. The risk assessment will focus on issues of particular concern to human health and/or the environment.

The information needed to support an application for assessment will be set out in delegated legislation. Further details will be set out in the Characterisation Guide (and associated guidance materials) and on the approved application form.

Some general comments on required information are included in Table 12 in question and answer style. We provide more detail on the requirements below the table.

Table 12 - General comments on the required information for Assessed introductions

Question

Answer

How were the requirements and the types of information that may be used to address the requirements determined?

The requirements were determined based on consideration of:

  • the information required for chemicals to be added to the Inventory following assessment
  • the information that may be available to address each of the endpoints, taking into account information requirements of other jurisdictions
  • the information required to undertake risk assessments and make recommendations to risk managers
  • the practicality of obtaining the information
  • the need for reduced reliance on information obtained using animal testing
  • the level of acceptance and validation of alternatives to animal testing
  • feedback obtained on previous Consultation Papers
  • risk-based and proportionate regulatory impacts and outcomes.

Are the requirements the same for all applications for assessment?

As all chemicals in this category will be ultimately included on the Inventory, the chemical identity requirements will be the same for all applications.

The hazard requirements will generally correspond to the minimum information requirements for categorisation according to the Exposure Band (see Part 5 for further details); i.e. the level of hazard characterisation required will be commensurate with the predicted level of exposure. An introducer will need to provide all available data on the chemical, which may be more than the minimum requirements.

Other general requirements (including physico-chemical and introduction/use/exposure) will be the same for all applications for assessment. However, as the assessment will focus on the issues of concern for human health and/or the environment, the level of information that will be required in the approved form to address the requirements may vary depending on the circumstances of the assessment; e.g. depending on if the introduction is categorised as:

  • Assessed due to categorisation for human health and the environment as Assessed
  • Assessed due to categorisation for human health or the environment as Assessed (with the other being categorised as Exempted or Reported), or
  • Exempted or Reported, with the introducer choosing to apply for an assessment.

The requirements are detailed below this table. Information to address the requirements will be detailed in the Characterisation Guide (and associated guidance materials) and on the approved application form, and will be consulted on later in the year.

Additional specified information requirements will apply in some circumstances (see Part 6 for further details).

Additional information may also be requested from the applicant over the course of an assessment.

Will there be any information waivers available when submitting an application for assessment?

Specified information waivers will apply for certain hazard endpoints. These are largely expected to align with those identified for the minimum information requirements (see Part 5 for further details).

Specified information waivers will also apply for certain physico-chemical endpoints (see Consultation Paper 5 Supporting Material for further details). The waivers may vary based on the circumstances of the assessment (similar to the information to address the requirements, as discussed above).

It will also be possible to apply for case-by-case information waivers when submitting applications for assessment.

Chemical identity

Required information related to chemical identity:

  • proper chemical name, i.e. CAS name and/or IUPAC name
  • CAS number (if available)
  • proposed AICIS approved chemical name (AACN, if relevant)
  • common name/trade name/marketing name
  • synonyms (if available, e.g. chemical identifiers in study reports)
  • molecular formula (if defined)
  • structural formula (if defined)
  • molecular weight or weight range (if defined)
  • composition (e.g. purity, identity of impurities, reactants, and additives/adjuvants), identity and ratio of component chemicals as far as is known if a UVCB, and if such composition changes batch-to-batch)
  • analytical information (enough information sufficiently characterise the chemical) and
  • as complete a description as possible if the chemical is a UVCB (e.g. CAS description, details of the immediate precursors/natural sources).

If your chemical is a polymer, in addition to the above, you will also need:

  • identity and percentage of all polymer constituents prior to polymerisation
  • the percentage residual of each constituent remaining (by weight) following completion of the polymerisation
  • molecular weight distribution of the polymer:
  • the percentage of low molecular weight oligomeric species:
    • below 1,000 Daltons, and
    • below 500 Daltons.

Physico-chemical properties

Required information related to physico-chemical properties:

  • melting point/freezing point
  • boiling point
  • density
  • vapour pressure
  • water solubility
  • hydrolysis as a function of pH
  • partition coefficient (n-octanol/water)
  • adsorption and desorption
  • dissociation constant
  • particle size (distribution)/fibre length (for solids only)
  • flashpoint
  • flammability limits
  • auto-ignition temperature
  • explosive properties, and
  • reactivity (oxidising properties, conditions causing instability, decomposition products).

General introduction information

Required general introduction information:

  • mode of introduction (import or manufacture)
  • introduction volume of the chemical for each of the first five years
  • proposed end use(s) for the chemical, and proportion of the introduction volume expected to be associated with each end use sector
  • proposed Safety Data Sheet and labels, and
  • details of any known assessments of the chemical by other national or international regulatory agencies (e.g. agency and year).

Exposure and release information

Required exposure and release information:

  • the manufacture and reformulation processes
  • details relevant to worker exposure (e.g. who will handle the chemical and in what form/concentration; any controls, including engineering, PPE and administrative, that will be in place to prevent exposure to the chemical)
  • whether members of the public will handle the chemical or products containing the chemical, and if so, in what form and concentration, and
  • details relevant to environmental exposure (e.g. sites of manufacture/reformulation and end use, anticipated environmental release/disposal methods at the end of the chemical’s useful life).

Hazard and fate information:

Required hazard and fate information:

  • human health hazard information requirements, generally consistent with the minimum requirements identified in Part 5 and Part 6, and any other hazard information available to the introducer
  • environmental hazard and fate information requirements to address:
    • persistence in the environment (e.g. biodegradability data)
    • bioaccumulation potential (partition coefficient or bioaccumulation factor data)
    • toxicity to organisms (e.g. data for fish, invertebrates and algae).

Next - Part 5: Categorising an unlisted chemical introduction - hazard information requirements

Part 5: Categorising an unlisted chemical introduction – hazard information requirements

Download Consultation Paper 5 [PDF 2.8 MB]

Go to the start of Consultation Paper 5

Read Consultation Paper 5 supporting material

The following links take you to the various parts of this section.

5.1 General overview

Following determination of the appropriate Exposure Band for human health and the environment, it is necessary to identify the hazards relevant to the Exposure Band. This is so the relevant human health and environment introduction categories may be determined.

A number of concepts apply to the information requirements for human health and the environment. We discuss these concepts (in question and answer style) in Table 13.

Table 13 - General information on the hazard requirements for categorisation

Question

Answer

What is the structure of the information requirements for the purposes of categorising an unlisted chemical introduction?

In general, two sets of information requirements apply for the Exposure Bands when categorising an unlisted introduction:

  • Minimum information requirements, which vary according to the Exposure Band, so that the level of hazard characterisation required will be commensurate with the predicted level of exposure.
  • Information requirements for a chemical to be categorised as Exempted for human health or the environment. To determine that a chemical can be categorised as Exempted, additional information beyond the minimum requirements for the relevant Exposure Band is generally required (with the level of information required also varying according to the Exposure Band).

We provide more details on these requirements below this table. The information requirements for high molecular weight polymers (i.e. with NAMW ≥1000 Da) may be different to those needed for chemicals and low molecular weight polymers (i.e. with NAMW <1000 Da) in the same Exposure Band (discussed further below).

Note that this section concerns the information requirements that will apply in most circumstances. In specified cases, additional information requirements may apply (see Part 6 for further details).

Where can I find more details on the information that may be used to address each of the requirements?

Consultation Paper 5 Supporting Material describes, in detail, information that may be used to address each requirement for chemicals and low molecular weight polymers. Although this level of detail will not be in the delegated legislation (but rather in the Characterisation Guide and supporting guidance material), it is being consulted on now so that stakeholders can see how the information requirements will work and provide early feedback.

We will consult on the information to address requirements for high molecular weight polymers later in the year.

How were the requirements and the types of information that may be used to address the requirements determined?

The requirements for each Exposure Band were determined based on consideration of:

  • the information that may be available to address each of the hazard endpoints, taking into account information requirements of other jurisdictions
  • the practicality of obtaining the information
  • the information required to undertake risk assessments and make recommendations to risk managers
  • the need for reduced reliance on information obtained using animal testing
  • the level of acceptance and validation of alternatives to animal testing
  • feedback obtained on previous Consultation Papers
  • risk-based and proportionate regulatory impacts   and outcomes.

What do I need to consider when addressing the requirements?

Introducers need to consider all hazard information available to them when characterising the hazard for the purpose of categorisation. This may also be more than the specified information requirements for the relevant Exposure Band.

If existing in vivo data on the chemical (or suitable analogue(s)) are available, the information requirements will be satisfied without the need for further testing.

Introducers need to consider data ownership and any relevant permissions required to use data for this purpose.

With respect to the hazard characteristics of highest concern (and uncertainty) to human health or the environment, the minimum information requirements will often be a determination of whether the chemical is known to have the characteristics based on specified lists and existing information. If the chemical is identified as having the hazard characteristics it will fall under Hazard Band D for human health or Hazard Band E for environment. For categorisation purposes, if the introduced chemical is an ester or salt of a chemical identified as having these characteristics, the introduced chemical should also be considered to have these characteristics.

We will draft and consult on guidance on the suitability of analogues later this year. For further details of the planned guidance, see Consultation Paper 5 Supporting Material.

Where possible, we have provided options to address each requirement. In choosing the most appropriate option, consider:

  • the nature of the chemical
  • the availability of existing information on the chemical (or suitable analogue) that meets the information requirements
  • the applicability of the different prediction and testing options (in silico, in chemico, in vitro and in vivo)
  • for example, in silico predictions may be acceptable in some instances, if the chemical is within the applicability domain of the in silico model

In general, where positive results are obtained, the ‘weight’ given to the type of data to inform a particular hazard will be prioritised as follows: in silico < in chemico < in vitro < in vivo.

Will there be any information waivers available when categorising an introduction?

Specified information waivers will apply for certain hazard endpoints for the purposes of categorising an introduction:

  • the waivers may be used to negate, replace, or supplement the corresponding information requirement
  • in many cases, the waivers vary with exposure band.

Examples of the types of waivers that may apply are included in Consultation Paper 5 Supporting Material.

Can I consider my chemical to be positive for a particular hazard for the purposes of categorisation, in lieu of hazard information

For the purposes of categorising an introduction, instead of information being obtained to address a particular hazard characteristic, introducers may choose to have the chemical considered as being positive for the endpoint. This may result, for example, in the introduction being categorised as Assessed.

Information requirements when applying for an assessment by us will still apply. However, it may be possible to apply for case-by-case waivers in these instances (only specified waivers will apply for the purposes of categorising an introduction).

Will the information requirements for high and low molecular weight polymers be the same?

No, the information requirements for high and low molecular weight polymers may be different, depending on the Exposure Band. We will consult on the information to address requirements for high molecular weight polymers later in the year.

For example, it will not generally be necessary to hold or generate human health hazard information on high molecular weight polymers. However, if such information exists (such as existing hazard classifications or available toxicity information) it should be considered when determining the polymer’s human health hazard band. The polymer’s expected human health hazard will largely be based on structural considerations.


Next - Part 6: Specified chemical introductions - additional requirements

5.2 Information requirements to determine the human health introduction category

Go back to the start of Part 5 Categorising an unlisted chemical introduction - hazard information requirements

We outline the hazard characteristics for human health that you must address (per Exposure Band) in this section. Details include:

The reason additional information is required for categorising as Exempted for most Exposure Bands is because there will be no pre-introduction interactions with us for Exempted introductions (and we will not be advised of the chemical details). Thus, the introducer must have the information that shows the chemical is not hazardous to human health.

The information requirements do not necessarily address all Hazard Band criteria. In some cases, the chemical would only be in the Hazard Band:

  1. based on structural considerations and uncertainties associated with the hazard characteristics
  2. because the chemical was already known to have that hazard
  3. if the hazard characteristic was noted while addressing other specified requirements (e.g. specific target organ toxicity (single exposure) effects evident when addressing the requirements for acute toxicity).

The minimum information requirements to categorise a high molecular weight polymer are based mainly on structural considerations. In most cases, it will not be necessary to hold or generate human health hazard information on these polymers. However, if such information already exists, it should be used when determining the appropriate hazard band for the polymer.

For the minimum information requirements, Table 14 provides a summary of the hazard characteristics that must be addressed for each Exposure Band for chemicals and for low molecular weight polymers. Detailed discussion follows the table. For the actual information requirements to address each hazard characteristic, see Consultation Paper 5 Supporting Material.

Table 14 - Minimum information requirements per human health Exposure Band

Hazard characteristics

Minimum information requirements (per Exposure Band)

1

2

3

4

5

If known (based on specified lists6 and existing information):

  • carcinogenicity
  • reproductive and developmental toxicity
  • adverse effects known to be mediated by an endocrine disruption mode of action.

-

Yes

Yes

Yes

Yes

Mutagenicity/genotoxicity (For Exposure Bands 2 and 3 this is based on specified lists6 and existing information)

-

Yes

Yes

Yes

Yes

Acute toxicity (oral, or whichever other exposure route is most relevant)

-

-

-

Yes

Yes

Skin corrosion and eye damage

-

-

-

Yes

Yes

Skin sensitisation

-

-

-

Yes

Yes

Skin and eye irritation

-

-

-

-

Yes

Specific target organ toxicity (repeated exposure)

-

-

-

-

Yes

6 The specified lists will be publicly available. Refer to Section 3 of Consultation Paper 5 Supporting Material for further information.

Exposure Band 1 (chemicals and polymers)

There will be no information requirements when categorising the chemical introduction for human health for this Exposure Band. This is because the very low indicative risk for these chemicals is based on the very low expected human exposure.

Exposure Band 2 (chemicals and polymers)

The minimum information requirements will be a determination of whether the chemical is known to be any of the following based on specified lists and existing information:

  • carcinogenic
  • mutagenic/genotoxic
  • a reproductive or developmental toxicant
  • a chemical with adverse effects known to be mediated by an endocrine disruption mode of action.

Further information on how an introducer shows this for chemicals and polymers with NAMW ≤1,000 Da is included in Consultation Paper 5 Supporting Material. If the chemical is identified as having these hazard characteristics (and/or uncertainties with respect to hazard characteristics), it falls under Hazard Band D.

If the chemical falls under Hazard Band D, the introduction will be categorised as Assessed for human health. If it does not fall under Hazard Band D, because it does not have any of the above characteristics, the introduction may be categorised as Exempted for human health.

Exposure Band 3

Exposure Band 3 (chemicals and low molecular weight polymer)

Like Exposure Band 2, the minimum information requirements will be a determination of whether the chemical is known to be any of the following based on specified lists and existing information:

  • carcinogenic
  • mutagenic/genotoxic
  • a reproductive or developmental toxicant
  • a chemical with adverse effects known to be mediated by an endocrine disruption mode of action.

If the chemical falls under Hazard Band D, the introduction will be categorised as Assessed for human health. If it does not fall under Hazard Band D, because it does not have any of the above characteristics, the introduction may be categorised as Reported for human health.

Exposure Band 3 (optional) – additional requirements to demonstrate that a chemical or a low molecular weight polymer is not hazardous

For introductions to be categorised as Exempted it will be necessary to show that the chemical does not have the characteristics described in Hazard Bands B, C, and D. Additional information requirements apply to address these hazard characteristics:

  • mutagenicity/genotoxicity (information additional to checking of specified lists)
  • acute toxicity (oral, or whichever exposure route is most relevant)
  • specific target organ toxicity (repeated exposure)
  • skin and eye damage/irritation
  • skin sensitisation.

Exposure Band 3 (high molecular weight polymer)

The Minimum information requirements will be:

  • a determination of whether the polymer is known to be any of the following based on specified lists and existing information:
    • carcinogenic
    • mutagenic/genotoxic
    • a reproductive or developmental toxicant
    • a chemical with adverse effects known to be mediated by an endocrine disruption mode of action.
    • consideration of any existing hazard information on the polymer
    • consideration of the other hazard band criteria relevant to polymers

If the polymer falls under Hazard Band D, the introduction will be categorised as Assessed for human health. If the polymer does not fall under Hazard Band D, the introduction may be categorised as Reported for human health.

Exposure Band 3 (optional) – additional requirements to demonstrate that a high molecular weight polymer is not hazardous

Additional considerations for polymers with NAMW ≥1,000 Da may result in the polymer introduction being categorised as Exempted. This could involve consideration of:

  • the PLC criteria – if the polymer meets the PLC criteria, it will be categorised as Exempted, except under specific circumstances (see Part 3).
  • any existing hazard information on the polymer that could rule out hazards in Hazard Bands B or C.
  • the minimum information (on the polymer itself or a suitable analogue) required to demonstrate that a polymer is not hazardous is:
    • acute toxicity by a relevant route of exposure
    • skin irritation
    • eye irritation
    • mutagenicity/genotoxicity – bacterial reverse mutation.

If the polymer contains one or more high concern RFGs with a functional group equivalent weight <5,000, as defined in the PLC criteria, you are also required to have information on skin sensitisation potential. This does not apply to un-substituted positions ortho and para to phenolic hydroxyl or partially-hydrolysed acrylamides.

All such information should indicate that the polymer is not hazardous.

Exposure Band 4 (chemicals and low molecular weight polymer)

Minimum information requirements will apply to address the following hazard characteristics:

  • carcinogenicity (if known)
  • reproductive or developmental toxicity (if known)
  • adverse effects known to be mediated by an endocrine disruption mode of action (if known)
  • mutagenicity/genotoxicity
  • acute toxicity (oral, or whichever other exposure route is most relevant)
  • skin corrosion and eye damage
  • skin sensitisation.

If the chemical falls under Hazard Band C or D, the introduction will be categorised as Assessed for human health. If it does not fall under Hazard Band C or D, the introduction may be categorised as Reported for human health.

As previously indicated, the information requirements do not necessarily address all Hazard Band criteria. An example of this is specific target organ toxicity (repeated exposure), which is included in Hazard Band C. Information on toxicity after repeated exposure is not a requirement for chemical introductions in Exposure Band 4 to be categorised as Reported. If such information is available however, it should be considered to determine whether the chemical should be placed in Hazard Band C.

Exposure Band 4 (optional) – additional requirements to demonstrate that a chemical or a low molecular weight polymer is not hazardous

For introductions to be categorised as Exempted, it will be necessary to have information to show that the chemical does not have the characteristics described in Hazard Bands B, C, and D. Additional information requirements apply to address these hazard characteristics:

  • specific target organ toxicity (repeated exposure)
  • skin and eye irritation.

Exposure Bands 4 – 5 (high molecular weight polymer)

The minimum information requirements will be:

  • a determination of whether the polymer is known to be any of the following based on specified lists and existing information:
    • carcinogenic
    • mutagenic/genotoxic
    • a reproductive or developmental toxicant
    • a chemical with adverse effects known to be mediated by an endocrine disruption mode of action.
  • consideration of any existing hazard information on the polymer
  • consideration of the other hazard band criteria relevant to polymers

If the polymer falls under Hazard Band D, the introduction will be categorised as Assessed for human health. If the polymer does not fall under Hazard Band D, it may fall into Hazard Band B or C, and its introduction categorised as Reported or Assessed for human health.

Exposure Bands 4 and 5 (optional) – additional requirements to demonstrate that a high molecular weight polymer is not hazardous

Additional considerations for polymers with NAMW ≥1,000 Da may result in the polymer introduction being categorised as Exempted. This could involve consideration of:

  • the PLC criteria - if the polymer meets the PLC criteria, it will be categorised as Exempted, except under specific circumstances (see Part 3)
  • any existing hazard information on the polymer that could rule out hazards in Hazard Bands B or C
  • the minimum information (on the polymer itself or a suitable analogue) required to demonstrate that a polymer is not hazardous is:
    • acute toxicity by a relevant route of exposure
    • skin irritation
    • eye irritation
    • mutagenicity/genotoxicity – bacterial reverse mutation.

If the polymer contains one or more high concern RFGs with a functional group equivalent weight <5,000 Da, as defined in the PLC criteria, you are also required to have information on skin sensitisation potential. This does not apply to un-substituted positions ortho and para to phenolic hydroxyl or partially-hydrolysed acrylamides.

All such information should indicate that the polymer is not hazardous.

Exposure Band 5 (chemicals and low molecular weight polymers)

Minimum information requirements will apply to address the following hazard characteristics:

  • carcinogenicity (if known)
  • reproductive or developmental toxicity (if known)
  • adverse effects known to be mediated by an endocrine disruption mode of action (if known)
  • mutagenicity/genotoxicity
  • acute toxicity (oral, or whichever other exposure route is most relevant)
  • specific target organ toxicity (repeated exposure)
  • skin corrosion/irritation and eye damage/irritation
  • skin sensitisation.

If the chemical falls under Hazard Band C or D, the introduction will be categorised as Assessed for human health. If it does not fall under Hazard Band C or D, the introduction may be categorised as Reported for human health.

In this Exposure Band, the same information requirements apply when categorising the introduction for human health and when demonstrating that a chemical is not hazardous. This greater level of information to characterise the hazards is commensurate with the potential for increased exposure in this highest Exposure Band.

Options to demonstrate that a chemical is not hazardous to human health

To characterise chemicals (and low molecular weight polymers) in Exposure Bands 3-5 as non-hazardous, it is necessary to show the chemical does not have the hazard characteristics associated with Hazard Bands B-D. Consultation Paper 5 Supporting Material provides further details on information requirements to address each hazard characteristic.

A summary of the types of information you can provide to show that a chemical is not hazardous is included in Table 15. Where possible, options are provided that take into account in silico, in chemico, in vitro and in vivo information sources, with the level of information required commensurate with the predicted level of exposure.

Table 15 - Information types to demonstrate a chemical is not hazardous

Hazard characteristics

Options to demonstrate that a chemical is not hazardous for human health (per Exposure Band)

Exposure Band 3

Exposure Band 4

Exposure Band 5

In silico

In silico / in chemico/in vitro7

In chemico / in vitro

In vivo8

In silico

In silico / in chemico / in vitro

In vitro

In vivo

In silico

In silico / in chemico / in vitro

In vitro

In vivo

Mutagenicity/genotoxicity

 

Yes

 

Yes#

  

Yes

Yes#

  

Yes

Yes#

Acute toxicity

 

Yes

 

Yes

   

Yes

   

Yes

Specific target organ toxicity (repeated exposure)

   

Yes

   

Yes

   

Yes

Serious eye damage

Yes

 

Yes

Yes

  

Yes

Yes

  

Yes

Yes

Eye irritation

Yes

 

Yes

Yes

  

Yes

Yes

  

Yes

Yes

Skin corrosion

Yes

 

Yes

Yes

  

Yes

Yes

  

Yes

Yes

Skin irritation

Yes

 

Yes

Yes

  

Yes

Yes

  

Yes

Yes

Skin sensitisation

 

Yes

 

Yes

 

Yes

 

Yes

 

Yes

 

Yes

7 Combination of in silico and in chemico/in vitro required.

8 Level of information required (e.g. existing published information vs test report) depends on hazard characteristic and Exposure Band.

# For categorisation, an available in vivo test result is an acceptable option in all circumstances to meet the information requirements to demonstrate the chemical is not genotoxic or mutagenic. Generation of new in vivo information is only required under certain circumstances e.g. to meet information requirements for Assessed chemicals, where an in vitro assay has predicted a positive mechanism an in vivo study addressing that mechanism is required.


Next - Section 5.3: Information requirements to determine the environment introduction category

5.3 Information requirements to determine the environment introduction category

Go back to the start of Part 5 Categorising an unlisted chemical introduction - hazard information requirements

This section outlines what hazard characteristics for the environment need to be addressed (per Exposure Band). Details include the:

  • minimum information requirements to categorise a chemical introduction for the environment as either Assessed or not Assessed (which in most cases will mean that the introduction will default to Reported)
  • information required if you want to demonstrate that a chemical introduction is Exempted.

The reason additional information is required for categorising as Exempted for most Exposure Bands is because there will be no pre-introduction interactions with us for Exempted introductions (and we will not be advised of the chemical details). Thus, the introducer must have the information that shows the chemical is very low risk to the environment.

For the minimum information requirements, Table 16 provides a summary of the hazard characteristics that must be addressed for each Exposure Band to determine if the chemical introduction is Assessed or not Assessed. If the chemical introduction is not Assessed, it will default to being Reported.

Table 17 outlines additional hazard characteristics that must be addressed for each Exposure Band to determine if a chemical introduction that is not Assessed is Exempted. Detailed discussion follows the table. Measured, analogue or modelled data may be used in different circumstances. The detailed information requirements to address each hazard characteristic are outlined in Consultation Paper 5 Supporting Material.

Table 16 - Minimum information requirements per environment Exposure Band (to determine if a chemical introduction is Assessed or not Assessed)

Hazard characteristics

Minimum information requirements (per Exposure Band)

1

2

3

4

5

6

If known to be (based on specified lists9 and existing information):

  • Persistent, Bioaccumulative and Toxic (PBT)
  • an ozone depleting chemical
  • a chemical that contains a sequence of one or more fully fluorinated carbon atoms
  • a chemical that contains high concern inorganic elements (mercury, lead, cadmium, and arsenic)
  • a chemical with adverse effects known to be mediated by an endocrine disruption mode of action.

-

Yes

Yes

Yes

Yes

Yes

Persistence information (P): Biodegradability (ready/inherent)

-

-

-

Yes*

Yes #

Yes #

Bioaccumulation information (B): Bioaccumulation potential (partition coefficient (log Kow or BAF/BCF)

-

-

-

Yes*

Yes #

Yes #

Toxicity information (T): Acute aquatic toxicity for the three trophic levels (fish, invertebrates and algae)

-

-

-

Yes*

Yes

Yes

9 The specified lists will be publicly available. Refer to Section 3 of Consultation Paper 5 Supporting Material for further information.

* Only one end point that demonstrates a chemical is either not P, not B or not T (and therefore not PBT) is required.

# Information on both P and B may not be required for categorisation, depending on the acute aquatic toxicity of the chemical.

Table 17 - Information requirements to categorise a chemical for the environment as Exempted

Hazard characteristics

Information requirements (per Exposure Band)

1

2

3

4

5

6

Very toxic to aquatic organisms (based on specified lists and existing information)

-

Yes

-

-

-

-

Persistent and Bioaccumulative (PB) (based on specified lists and existing information)

-

Yes ^

-

-

-

-

Persistence information (P): Biodegradability (ready/inherent)

-

-

Yes ^

Yes ^

Yes

Yes

Bioaccumulation information (B): Bioaccumulation potential (partition coefficient (logKow) or BAF/BCF)

-

-

Yes ^

Yes ^

Yes

Yes

Toxicity information (T): Acute aquatic toxicity for the three trophic levels (fish, invertebrates and algae)

-

-

Yes

Yes

Yes

Yes

^ Only one endpoint to demonstrate a chemical is either not P or not B (and therefore not PB) is required.

Exposure Band 1

There will be no information requirements when categorising the chemical introduction for environment for this Exposure Band. This is because the very low indicative risk for these chemicals is based on the very low expected environmental exposure.

Exposure Band 2

The minimum information requirement will be a determination of whether the chemical is known to be any of the following (characteristics found in Hazard Band E) based on specified lists and existing information:

  • Persistent, Bioaccumulative and Toxic (PBT, according to the national PBT criteria)
  • ozone depleting
  • a chemical that contains a sequence of ≥4 and ≤20 fully fluorinated carbon atoms
  • a chemical that contains high concern inorganic elements (mercury, lead, cadmium, and arsenic)
  • a chemical with adverse effects known to be mediated by an endocrine disruption mode of action.

If the chemical has any of these characteristics, it falls under Hazard Band E and the introduction will be categorised as Assessed for environment. If the chemical is not known to have any of these characteristics then it will be categorised as Reported for environment.

Exposure Band 2 – requirements to categorise as Exempted

For introductions to be categorised as Exempted it will be necessary to know that the chemical does not have any of the following (characteristics described in Hazard Band D) based on specified lists and existing information:

  • very toxic to aquatic organisms or
  • Persistent and Bioaccumulative (PB).

Exposure Band 3

The minimum information requirements will be a determination of whether or not the chemical is known to be any of the following based on specified lists and existing information:

  • Persistent, Bioaccumulative and Toxic (PBT, according to the national PBT criteria)
  • ozone depleting
  • a chemical that contains a sequence of ≥4 and ≤20 fully fluorinated carbon atoms
  • a chemical that contains high concern inorganic elements (mercury, lead, cadmium and arsenic)
  • a chemical with adverse effects known to be mediated by an endocrine disruption mode of action.

If the chemical has any of these characteristics, it falls under Hazard Band E and the introduction will be categorised as Assessed for environment. If it does not have any of the above characteristics, the introduction may be categorised as Reported for environment.

Exposure Band 3 (optional) – additional requirements to categorise as Exempted

For introductions to be categorised as Exempted it will be necessary to show that the chemical does not have the characteristics described in Hazard Bands C, D, and E. In addition to the compulsory considerations, the chemical must not have any of the following additional hazard characteristics (that are found in Hazard Band D and C):

  • toxic to aquatic organisms
  • Persistent and Bioaccumulative (PB).

To show that the chemical does not possess these characteristics the following minimum information would be needed:

  • Acute aquatic toxicity for the three trophic levels (fish, invertebrates and algae)
  • at least one of the following:
    • persistence information: biodegradation (ready or inherent)
    • bioaccumulation information: partition coefficient (log Kow) or bioaccumulation (BAF / BCF).

However, if either the persistence or bioaccumulation information indicates a P or B result, the other test is needed to show if the chemical is PB.

Exposure Band 4

The first step in characterising the hazard for chemicals in these exposure bands is determining if the chemical is already known (based on specified lists and existing information) to have any of the characteristics in Hazard Band E, that is:

  • Persistent, Bioaccumulative and Toxic (PBT, according to the national PBT criteria)
  • ozone depleting
  • a chemical that contains a sequence of ≥4 and ≤20 fully fluorinated carbon atoms
  • high concern inorganic elements (mercury, lead, cadmium, and arsenic)
  • a chemical with adverse effects known to be mediated by an endocrine disruption mode of action.

If the chemical is identified as having any of these characteristics it falls under Hazard Band E and the introduction will be categorised as Assessed for environment.

If the above information is not available (i.e. the chemical is not found on specified lists or there is no existing information available), then at least one of the following minimum information requirements will be needed to characterise the hazards of the chemical to determine if it has PBT characteristics:

  • acute aquatic toxicity for the three trophic levels (fish, invertebrates and algae)
  • persistence information: biodegradability (ready or inherent)
  • bioaccumulation potential: partition coefficient (logKow) or bioaccumulation (BAF/BCF).

If the toxicity, persistence or bioaccumulation information indicates a T or P or B result, the other tests may be required to show if the chemical is PBT.

Depending on the hazard characterisation arising from this information, the chemical introduction may be categorised as either Assessed or not Assessed (default to Reported) for the environment.

Exposure Band 4 (optional) – additional requirements to categorise as Exempted

As for Exposure Band 3, for introductions to be categorised as Exempted it will be necessary to show that the chemical does not have the characteristics described in Hazard Bands C, D and E. In addition to the compulsory considerations, the chemical must not have any of the following additional hazard characteristics (that are found in Hazard Band D and C):

  • toxic to aquatic organisms (according to the GHS)
  • Persistent and Bioaccumulative (PB)
  • fully fluorinated carbon atoms in a sequence of ≤3 or ≥21.

To show that the chemical does not possess these characteristics the following minimum information would be needed:

  • acute aquatic toxicity for the three trophic levels (fish, invertebrates and algae)
  • information to indicate if the chemical has fully fluorinated carbon atoms in a sequence of ≤3 or ≥21.
  • At least one of the following:
    • persistence information: biodegradation (ready or inherent)
    • bioaccumulation potential: partition coefficient (log Kow) or bioaccumulation (BAF / BCF).

However, if either the persistence or bioaccumulation information indicates a P or B result, the other test is needed to show if the chemical is PB.

Exposure Band 5

The first step in characterising the hazard for chemicals in these exposure bands is determining if the chemical is already known (based on specified lists and existing information) to have any of the characteristics in Hazard Band E, that is:

  • Persistent, Bioaccumulative and Toxic (PBT, according to the national PBT criteria)
  • a chemical with adverse effects known to be mediated by an endocrine disruption mode of action
  • ozone depleting
  • a chemical that contains a sequence of ≥4 and ≤20 fully fluorinated carbon atoms
  • high concern inorganic elements (mercury, lead, cadmium, and arsenic).

If the chemical is identified as having any of these characteristics it falls under Hazard Band E and the introduction will be categorised as Assessed for environment.

If the chemical does not fall under Hazard Band E then the following minimum information will be needed to characterise the hazards of the chemical to determine if it meets the criteria for Hazard Band D:

  • acute aquatic toxicity for the three trophic levels (fish, invertebrates and algae)
  • information to indicate if the chemical has fully fluorinated carbon atoms in a sequence of ≤3 or ≥21
  • at least one of the following:
    • persistence information: biodegradability (ready or inherent)
    • bioaccumulation potential: partition coefficient (log Kow) or bioaccumulation (BAF/BCF).

However, if either the persistence or bioaccumulation information indicates a P or B result, the other test is required to show if the chemical is PB.

Depending on the hazard characterisation arising from this information, the chemical introduction may be categorised as either Assessed or not Assessed (default to Reported) for the environment.

Exposure Band 5 (optional) – additional requirements to categorise as Exempted

For introductions to be categorised as Exempted it will be necessary to show that the chemical does not have the characteristics described in Hazard Bands B, C, D and E. In addition to the compulsory considerations, the chemical must not have any of the following additional hazard characteristics (that are found in Hazard Band B and C):

  • Bioaccumulative
  • not readily biodegradable
  • contain copper, nickel, zinc, silver, chromium or aluminium
  • polymers that have an overall cationic charge at pH 4-9
  • polymers that are not stable (unless a biopolymer).

To show that the chemical does not possess these characteristics the following additional minimum information would be needed:

  • Both of:
    • persistence information: biodegradation (ready or inherent)
    • bioaccumulation potential: partition coefficient (log Kow) or bioaccumulation (BAF / BCF).

Exposure Band 6

The first step in characterising the hazard for chemicals in these exposure bands is determining if the chemical is already known (based on specified lists and existing information) to have any of the characteristics in Hazard Band E, that is:

  • Persistent, Bioaccumulative and Toxic (PBT, according to the national PBT criteria)
  • ozone depleting
  • a chemical that contains a sequence of ≥4 and ≤20 fully fluorinated carbon atoms
  • high concern inorganic elements (mercury, lead, cadmium, and arsenic)
  • a chemical with adverse effects known to be mediated by an endocrine disruption mode of action.

If the chemical is identified as having any of these characteristics it falls under Hazard Band E and the introduction will be categorised as Assessed for environment.

If the chemical does not fall under Hazard Band E then the following minimum information will be needed to characterise the hazards of the chemical to determine if it meets the criteria for Hazard Band C or D:

  • acute aquatic toxicity for the three trophic levels (fish, invertebrates and algae)
  • information to indicate if the chemical has fully fluorinated carbon atoms in a sequence of ≤3 or ≥21
  • at least one of the following:
    • persistence information: biodegradability (ready or inherent)
    • bioaccumulation potential: partition coefficient (log Kow) or bioaccumulation (BAF/BCF).

However, if either the persistence or bioaccumulation information indicates a P or B result, the other test is required to show if the chemical is PB.

Depending on the hazard characterisation arising from this information, the chemical introduction may be categorised as either Assessed or not Assessed (default to Reported) for the environment.

Exposure Band 6 (optional) – additional requirements to categorise as Exempted

These requirements will be the same as for the optional requirements under Exposure Band 5. For introductions to be categorised as Exempted it will be necessary to show that the chemical does not have the characteristics described in Hazard Bands B, C, D and E. In addition to the compulsory considerations, the chemical must not have any of the following additional hazard characteristics (that are found in Hazard Band B and C):

  • Bioaccumulative
  • not readily biodegradable
  • contain copper, nickel, zinc, silver, chromium or aluminium
  • polymers that have an overall cationic charge at pH 4-9
  • polymers that are not stable  (unless a biopolymer).

To show that the chemical does not possess these characteristics the following additional minimum information would be needed:

  • Both of:
    • persistence information: biodegradation (ready or inherent); and
    • bioaccumulation potential: partition coefficient (log Kow) or bioaccumulation (BAF / BCF).

Next - Part 6: Specified chemical introductions - additional requirements

Part 6: Specified chemical introductions - additional requirements

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For some chemical introductions (see Table 18) the minimum information requirements will not be enough to determine the indicative risk, and thus the appropriate introduction category. This is because some classes of chemicals are known to have:

  • increased potential for adverse health and environmental effects (such as halogenated organic chemicals and biocides)
  • some end uses result in increased exposure to humans or the environment (such as chemicals in food contact materials and water treatment chemicals).

Under the current scheme, some of these chemicals have clearly stated additional information requirements (such as UV filters, and certain perfluorinated chemicals). For others we routinely request additional information during an assessment to address the known concerns.

We expect that it will be quite rare for these classes of chemicals to be introduced (see the description of the chemical introductions in the table below).

We propose to define these classes of chemical introductions in the delegated legislation because:

  • of the increased level of concern for many of these chemicals
  • to ensure increased transparency for introducers.

Our hazard characterisation guidance material will set out the extra information required for categorisation (see Consultation Paper 5 Supporting Material for examples).

Some of these chemical introductions will not be able to be categorised as Exempted (as it is most appropriate for us to have some information about their introduction). The exception to this is where they meet Exposure Band 1 requirements.

To allow us to conduct an adequate risk assessment during an assessment of these specified chemical introductions, we may request further information from introducers.

Table 18 - Specified chemical introductions with additional requirements

Class

Definition of the chemicals and end uses to which additional information will apply

Brief description of concern

Categorisation rules

Ultraviolet (UV) filters

A chemical that is solely or mainly intended to protect the skin against certain UV radiation by absorption, reflection or scattering of UV radiation.

UV filters have the potential to:

  • trigger photoallergenic contact dermatitis
  • be photo-unstable and potentially lead to phototoxic or photoallergic reactions
  • be dermally absorbed and be biologically active (e.g. endocrine disruption).
  • Cannot be Exempted (unless in Exposure Band 1)
  • additional information required for   categorisation and record keeping.

Genetically modified products (GM products)

Refer to the Gene Technology Act 2000.

There is potential for adverse effects from exposure to GM products, depending on the nature of the genetic modification.

Additional information required for record keeping.

Chemicals in food contact materials

A chemical with an end use that results in intentional direct contact with food (including drinking water). For example, packaging, containers, kitchenware, tableware, pipes, filters, coatings and adhesives.

Potential for leaching or migration from the food contact material into the food. This may result in ingestion.

Additional information required for categorisation and record keeping.

Certain chemicals with fluorinated functionality

Chemicals and polymers containing a sequence of ≥ 4 and ≤ 20 fully fluorinated carbon atoms.

Potential for degradation to chemicals that may be persistent in the environment, may bioaccumulate and may be highly toxic.

  • All introductions categorised as Assessed (unless in Exposure Band 1)
  • additional information required for assessment and record keeping.

Chemicals delivered directly to the lungs

Chemicals intended to be delivered directly to the lungs via an aerosol vapour. Examples include e-cigarettes, personal vaporisers, e-pens, e-cigars and e-hookah pens.

Potential for inhalation toxicity due to direct and intentional delivery to the respiratory system.

Additional information required for categorisation and record keeping.

Chemicals in tattoo inks

A chemical with an end use that involves direct injection into the dermis of the skin.

Chemicals in tattoo inks can persist in the body for many years.

Additional information required for categorisation and record keeping.

Chemicals with aspiration hazard potential

Chemicals containing the following structural characteristics/moieties:

  • n-primary alcohols with a composition of at least 3 carbon atoms but not more than 13
  • terpene alcohols
  • ketones with a composition of at least 3 carbon atoms but not more than 13
  • hydrocarbons with a composition of at least 3 carbon atoms but not more than 13.

Chemicals may be fatal if swallowed and they enter the airways.

Additional information required for categorisation and record keeping.

Biochemicals and biopolymers

Biochemical means a chemical, including a polymer, that is:

  1. directly produced by living or once-living cells or cellular components or
  2. a derivative or modification of a chemical referred to in paragraph (a) in which the original chemical remains substantially intact.

Viable production organism remaining in the biopolymer or biochemical may cause adverse effects.

Additional information required for categorisation and record keeping.

Biopolymers and biochemicals - enzymes

Any protein capable of catalysing a chemical reaction.

Many enzymes are known to be respiratory sensitisers.

Assumed to be respiratory sensitisers unless proven otherwise.

Chemicals with lung waterproofing effects

Chemicals that contain one or more hydrophilic groups, together with domains that are both hydrophobic and oleophobic.

These chemicals have the potential to spread across the alveolar surface of the lung and interfere with the oxygen exchange function.

Assumed to be fatal by inhalation (following single and repeated exposure) unless proven otherwise

Reactive polymers

Polymer with reactive functional groups if

  • NAMW ≥1,000 and <10,000 Da and
  • ≥5% low MW oligomeric species <1,000 Da or ≥2% low MW oligomeric species <500 Da
  • combined FGEW <1,000 (moderate concern groups only) or combined FGEW <5,000 (high concern and moderate concern groups)

These polymers have the potential to be mutagenic.

  • Additional information not required for categorisation
  • additional information required for assessment when in Exposure Band 4 or 5 and categorised as Assessed.

Halogenated organic chemicals

Halogenated organic chemicals apart from acyl halides.

These chemicals can potentially have the following effects:

  • persistence
  • bioaccumulation
  • endocrine disruption
  • cancer.

Additional information required for categorisation and record keeping.

Highly branched chemicals

Organic chemical which has a hydrocarbon chain containing one or more quaternary carbon atoms or more than one tertiary carbon atom.

These chemicals tend to be more resistant to degradation, leading to increased residence time in the environment, and the potential for accumulation in the environment.

Additional information required for categorisation and record keeping.

Chemicals released directly to the environment during use

Chemicals released directly to the environment during use. For example, dust suppression chemicals, water treatment chemicals, and other chemicals excluded from the Agvet Code

The end use of the chemicals involve direct release to the environment.

Additional information required for record keeping, especially detailed exposure information.

Biocides

Biocides that are excluded from APVMA and TGA legislation.

These chemicals are intended to have biological effects and are likely to have significant toxicity to certain organisms.

Additional information required for categorisation and record keeping.

Chemicals with uses resulting in significant diffuse emissions to areas of ecological significance

  • The Great Barrier Reef Marine Park
  • Commonwealth Marine Reserves
  • Ramsar Wetlands
  • World Heritage properties (such as Kakadu and Fraser Island).

The Australian Government recognises several areas that are of particular ecological significance that should be protected.

Additional information required for categorisation and record keeping.


Next - Part 7: Regulatory treatment of unlisted chemicals introduced at the nanoscale

Part 7: Regulatory treatment of unlisted chemicals introduced at the nanoscale

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The following links will take you to the various parts of this section:

Our previous consultation papers proposed the following for the regulatory treatment of unlisted nanomaterials:

  • that we assess all nanomaterials due to their uncertain hazards to human health and the environment
  • a definition of nanomaterials that is consistent with the current NICNAS working definition (see section 7.2 for the full definition).

We have modified our proposal to address stakeholder feedback and concerns. This proposal further refines the regulatory treatment of chemicals introduced at the nanoscale. It aims to ensure that these chemicals:

  • are appropriately categorised
  • the pre-introduction assessment focuses on those of most concern.

The proposal outlines the:

  • appropriate introduction categories, depending on the introduction volumes and uses
  • options for categorisation criteria to use to determine whether a pre-introduction assessment is required.

Further background details are included in section 7.2.


Next - Part 8: Commercial evaluation authorisation

7.1 Proposal for regulatory treatment of nanoscale chemicals

Go back to the start of Part 7 Regulatory treatment of unlisted chemicals introduced at the nanoscale

Categorisation outcomes

In order to refine their regulatory treatment and focus on the chemicals of most concern, it is proposed that introductions of unlisted chemicals consisting of particles at the nanoscale will not be categorised using the same hazard and exposure band criteria proposed for other chemicals.

Instead, criteria will be set using properties important for establishing which nano-scale chemicals require pre-introduction assessment.  The categorisation outcomes for unlisted chemicals consisting of particles at the nanoscale that meet the specific nano-scale criteria (discussed below) will be:

  • Exempted if introduced at ≤10 kg/annum for the purposes of research and development, or as a contained import/export introduction
  • Reported if introduced at >10 kg/annum and ≤100 kg/annum for the purposes of research and development
  • Assessed in all other circumstances.

The information we will need as part of the application for an Assessed introduction will be commensurate with the Exposure Band (similar to other types of industrial chemicals). We will consult further on these requirements later in the year.

For the introduction of chemicals consisting of particles at the nanoscale that do not meet the criteria discussed below, the categorisation will be the same as other unlisted industrial chemicals and may result in it being categorised as Assessed, Reported or Exempted. It will therefore depend on the exposure (volume and use) and the hazard characteristics of the chemical (with information requirements for hazard depending on the Exposure Band).

Categorisation criteria

We propose that criteria be prescribed to determine if the introduction of an unlisted chemical consisting of particles at the nanoscale will be categorised as Assessed, Reported or Exempted. This would be instead of having a static definition of a ‘nanomaterial’. This allows flexibility as criteria for industry self-categorisation could be different to the criteria we would use to appropriately focus an AICIS initiated evaluation of listed chemicals.

The categorisation criteria may incorporate some or all of the below elements:

  • size and distribution
  • intentionally manufactured
  • size-dependent properties
  • aggregates and agglomerates
  • solubility/dissolution rate.

Many of these elements are in our current working definition of nanomaterial and international definitions. We have reviewed each of these elements to consider their appropriateness in setting criteria to determine the categorisation outcomes for unlisted chemicals under the new framework.

Several options exist for which elements to include and how to incorporate each of the elements in the categorisation criteria. We have considered the impact of these elements (and how clearly they are expressed) on the ability to aid and enforce compliance under the new scheme, with its shift to more industry self-categorisation.

We discuss the relevant considerations for each of these elements below, as well as the possible categorisation criteria structure.

Possible elements of the categorisation criteria

The sections below outline the options for each of the possible elements of the categorisation criteria, listed in Table 19. This includes consideration of whether to include the element and options on incorporating it into the criteria.

Table 19 – Possible elements of the categorisation criteria for nanomaterials
Elements Size and distribution Intentionally manufactured Size dependent properties Aggregates and agglomerates Solubility/dissolution rate and persistence at the nanoscale
Size and distribution

The current working definition includes a nanoscale range, defined as:

  • ‘typically between 1 and 100 nm’, and
  • there is an interpretative note that ‘where a material includes 10% or more number of particles that meet the above definition (size, unique properties, intentionally produced) we will consider this to be a nanomaterial’.

The term ‘typically’ is ambiguous. It may cause issues for compliance and enforcement when applied in the context of industry self-categorisation. For this reason, an objective size range of 1-100 nm (as used in some overseas definitions or criteria) will be used. This has the advantage of being enforceable criteria if a compliance issue arises.

The use of a size distribution threshold is desirable but should be included with the size aspect so that these two closely related concepts are considered together.

We could maintain the current ‘10% by number’ threshold in the working definition, or alternatives could be considered, such as aligning with those implemented overseas:

  • 50% or more of the particles in the number size distribution (EU)
  • 10% by weight (US).

These distribution threshold options would need to be considered in conjunction with other criteria such as the size-dependent properties that may need to be included.

Both approaches have limitations. A size distribution based on particle number can bias the distribution to the smallest particles and so categorise a chemical at the nanoscale when the majority of particles are not in the nanoscale. Whereas a weight (or mass) based distribution has the potential to underestimate the true size distribution as the number of particles in any given mass of substance increases disproportionately as the size of the particle decreases.

Current state technology for measuring distribution thresholds for particles in the nanoscale also needs to be taken into account. For example, measuring particle numbers in the nanoscale with precision can be challenging, particularly when the threshold is low.

Have your say

Which size distribution threshold should be used in the categorisation criteria?

  1. 10% by number
  2. 50% by number
  3. 10% by weight?

Submit your comments here

Intentionally manufactured

The current working definition includes ‘intentionally produced, manufactured or engineered’ as well as an interpretative note that ‘intentionally produced, manufactured or engineered materials are distinct from accidentally produced materials’.

When considering this criterion in the context of unlisted chemicals, it is worth noting that under the reformed scheme, the following will be considered as excluded introductions (not needing categorisation):

  • naturally occurring nanoforms of chemicals
  • incidentally introduced chemicals.

The exclusion of these chemicals will thus not need to be taken into account when deciding what chemicals should be excluded through the nanoscale criteria.

Chemicals that are ‘incidentally introduced’ include those introduced because of:

  • impurities in other introduced chemicals
  • the occurrence of a chemical reaction during the manufacture or use of another chemical.

This applies only where the introduction of the incidentally introduced chemical has no commercial value, separate from the other chemical.

This exclusion of incidentally introduced chemicals would not cover the situation where only a proportion of the unlisted chemical is introduced at the nanoscale, but the introducer was not intending introduction at the nanoscale. Some of these situations may be covered if a size distribution threshold (such as 10% by number discussed above) was incorporated into the categorisation criteria for nanoscale chemicals.

The inclusion of an ‘intentionally introduced’ criterion may be challenging. It may create issues for compliance and enforcement, when trying to determine:

  • the introducer’s intent and
  • if the introducer has miscategorised their chemical introduction by declaring they did not intend for the nanoscale form to be present in the introduced chemical.

For introduction at the nanoscale it may be easier in some cases to determine the introducer’s intent if they are seeking specific properties that only occur at the nanoscale.

There is also the question if the potential risk to human health and the environment is any different when the nanoscale form is intended for introduction, as opposed to when it is unintentional.

The option for this criterion would be:

  1. not include the requirement for ‘intentionally produced, manufactured or engineered’
  2. include this requirement as a criterion that a chemical at the nanoscale (and with all other criteria fulfilled) would only be categorised as Assessed if the introducer intended its introduction at the nanoscale.
  3. include it as an exclusion criterion that a chemical at the nanoscale (and with all other criteria fulfilled) would be categorised as Assessed, unless the introducer could show that the introduction of the nanoscale form of the chemical is incidental to the introduction of the non-nanoscale form.

Have your say

Which option (1, 2 or 3) is appropriate for incorporation into categorisation criteria?

Submit your comments here

Size-dependent properties

The current working definition includes:

  • ‘unique properties or specific composition at the nanoscale’
  • there is an interpretive note that ’unique properties' refers to chemical and/or physical properties that are different because of a material’s nanoscale features when compared with the same material without nanoscale features, and result in ‘unique phenomena’
  • e.g. increased strength, chemical reactivity or conductivity that enables novel applications.

This criterion’s purpose would be to help focus regulatory activities on chemicals that have the potential for increased risk compared to their non-nano forms.

Including this criterion may cause difficulty for industry self-categorisation of unlisted chemicals as:

  • it is descriptive in nature
  • its interpretation may be subjective.

It would also be difficult to define and measure. This would increase the complexity in applying it. Also, this criterion assumes that there is a non-nanoscale form available for comparison. This may not be true for some unlisted chemicals.

This criterion may increase the likelihood of miscategorisation by an introducer. It may be difficult for us to determine compliance with the categorisation criteria.

It could be an exclusion criterion such that a chemical at the nanoscale (and with all other criteria fulfilled) would be categorised as Assessed, unless the introducer could show that the nanoscale form of the chemicals had the same reactivity and toxicity as the non-nanoscale form.

Some overseas regulatory definitions (e.g. EU and Canada) do not include size-dependent properties for chemicals introduced at the nanoscale of 1-100 nm. Others have included it in criteria where it has been appropriate for the context (e.g. US in the criteria for their “Nanoscale – Reporting Rule”).

Have your say

Should size-dependent properties be included as a criterion for categorisation of unlisted chemicals?

Submit your comments here

Aggregates and agglomerates

The current working definition includes materials that are ‘nanostructured (i.e. having an internal or surface structure at the nanoscale)’. The interpretative note says that ‘aggregates and agglomerates are considered to be nanostructured substances’.

Many other definitions/criteria are explicit in their consideration of aggregates and agglomerates, and do not include the term ‘nanostructured’.

An option to consider for the categorisation criteria is to replace ‘nanostructured substances’ with an explicit description of the inclusion of aggregates and agglomerates.

This would ensure the treatment of aggregates and agglomerates of nanoparticles is clear. Also, this would mean the criterion would not capture other type of materials such as nanoporous materials.

The options for this criterion would be:

  1. Keep the term ‘nanostructured’ and be explicit in the criterion (rather than a note) that this includes aggregates and agglomerates; or
  2. Remove the term ‘nanostructured’ and refer to particles (when describing the size range and distribution threshold) as being in the ‘unbound state or as a constituent of aggregates or agglomerates’.

Have your say

  1. Are there nanostructured chemicals (other than aggregates and agglomerates) that we should be capturing with this criterion?
  2. Which option (1 or 2) is appropriate for incorporation into categorisation criteria?

Submit your comments here

Solubility/dissolution rate and persistence at the nanoscale

The current working definition does not include the solubility/dissolution rate element, and it is not included in many other overseas definitions. It is included as a criterion in deciding which nanomaterials may need extra information to be submitted under the current notification and assessment framework.

It has been identified as a key parameter by the OECD Working Party on Manufactured Nanomaterials (WPMN).

If this were to be included as a criterion, the dissolution rate that triggered categorisation would need to be objectively defined in accordance with international guidelines. This is an active area of development under the OECD WPMN guidelines program.

In addition, we could take into account whether the chemical introduced at the nanoscale persisted at the nanoscale during its use. For example, polymer micelles at the nanoscale often do not persist outside of the environment in which they are contained.

Have your say

  1. Should solubility/dissolution rate be included as a criterion for categorisation of unlisted chemicals?
  2. Should the persistence at the nanoscale during use be included as a criterion for categorisation of unlisted chemicals?

Submit your comments here

Possible structure for categorisation criteria

We provide an example below of how some of the elements could be combined into categorisation criteria for unlisted chemicals. As this possible structure is just for example purposes, it makes a number of assumptions about which option is used for each of the elements.

Introduction of an unlisted chemical consisting of particles at the nanoscale will be categorised as Assessed if:

  1. The introduced chemical consists of particles, in an unbound state or as an aggregate or as an agglomerate, 10% of which (by number size distribution) have at least one external dimension in the nanoscale range of 1-100 nm, AND
  2. The chemical is introduced as a solid or in a dispersion.

unless the:

  • introduction is for the purposes of research and development and the introduction volume is less than 100 kg (Categorisation outcome = Reported or Exempted) OR
  • introduction is contained import/export (Categorisation outcome = Exempted) OR
  • introduced chemical rapidly dissolves in water (categorise in the same way as other unlisted chemicals) OR
  • introduced chemical does not persist at the nanoscale during its intended use (categorise in the same way as other unlisted chemicals) OR
  • the introduction of the nanoscale form of the chemical is incidental to the introduction of the non-nanoscale form (categorise in the same way as other unlisted chemicals).

Note that this example incorporates the following elements:

  • size and distribution
  • aggregates and agglomerates
  • solubility/dissolution rate and persistence at the nanoscale.

The example does not incorporate the following elements:

  • size-dependent properties.

Next - Section 7.2: Background

7.2 Background on regulatory treatment of nanoscale chemicals

Go back to the start of Part 7 Regulatory treatment of unlisted chemicals introduced at the nanoscale

In previous consultation papers, we proposed that nanomaterials would be characterised in the highest hazard bands for human health and the environment (due to the uncertainty about their risks and the complexity of the required risk assessment). Thus, they would be categorised as Assessed, except when introduced in scenarios fitting into Exposure Band 1 (i.e. Research and development ≤ 100 kg/annum, or contained import/export).

Stakeholders expressed concern about the way nanomaterials were being represented in the matrix, as well as views that the research and development volume threshold for Exposure Band 1 (≤ 100 kg/annum) was too high for nanomaterials.

Previous consultation papers also proposed that nanomaterials be defined in the new legislation using our current working definition for industrial nanomaterials, which is:

  • industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale)

Notes to the working definition:

  • intentionally produced, manufactured or engineered materials are distinct from accidentally produced materials
  • 'unique properties' refers to chemical and/or physical properties that are different because of a material's nanoscale features when compared with the same material without nanoscale features, and result in unique phenomena (e.g. increased strength, chemical reactivity or conductivity) enabling novel applications
  • aggregates and agglomerates are considered to be nanostructured substances
  • where a material includes 10% or more number of particles that meet the above definition (size, unique properties, intentionally produced) we will consider this to be a nanomaterial.

Stakeholder feedback on the proposal to use the working definition included concerns that the definition was too conservative in its use of a 10% by number particle threshold, with calls to align with other international definitions (US or EU).

We have used the working definition to:

  • facilitate voluntary calls for information
  • identify new chemicals unsuitable for current exemption categories
  • identify the notified chemicals that require additional data when assessed under the current ICNA Act.

The use of this definition for determining chemicals unsuitable for current exemption categories has involved self-assessment against the working definition by industry, but this has been limited to the low volumes allowable under the exemption categories (e.g. <100 kg/year).

The proposed categorisation framework for the reformed scheme is, however, significantly different to the current new chemicals notification framework, due to a greater reliance on self-categorisation by industry (including of higher volume introductions), in which the outcomes are:

  • Exempted (no reporting to us)
  • Reported (pre-introduction report to us)
  • Assessed (pre-introduction assessment by us).

The context in which a definition or set of criteria are being used to determine what is considered a ‘nanomaterial’ needing pre-introduction assessment is therefore different between the current and reformed schemes. Although the working definition has been very useful in administering the ICNA Act, it may not be directly applicable to the new risk-proportionate regulatory scheme the Australian Government has agreed. This new scheme has a very different balance of pre-and post-introduction assessment, with industry self-categorisation.

Since we developed our current working definition, considerable work on nanomaterials by bodies such as the OECD has taken place. Many other regulatory agencies have also now developed definitions and/or criteria to support their own work in this area. It is an opportune time to review our working definition and to decide how to use it (or elements of it) in the reformed industrial chemicals scheme.


Next - Part 8: Commercial evaluation authorisation

Part 8: Commercial evaluation authorisation

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8.1 General information and criteria

An application for a commercial evaluation authorisation could be made by any person proposing to introduce an industrial chemical for the purposes of ascertaining its potential for commercial application. The introduction and use of the chemical for this purpose must not involve:

  • the chemical being made available to the general public on its own, in combination with other chemicals or in an article
  • release of the chemical to the environment without prior treatment
  • uncontrolled use in the workplace.

Authorisations would be for a maximum of 4 years. However, our Director will refuse an application if reasonably satisfied that there are risks to human health and/or the environment that cannot be adequately managed (e.g. PBT chemicals).

The commercial evaluation authorisation pathway provides a means of bypassing the full assessment process in cases where the introduction is for the sole purpose of commercial evaluation, while still ensuring adequate safeguards. Given the focus of commercial evaluation authorisations and short assessment timeframe, we would not undertake a detailed assessment. Instead we would rely on the narrow scope of use and imposition of authorisation conditions in order to manage risk (including managing the uncertainty of the risk). Such conditions could include:

  • how the chemical may be used
  • the duration of the authorisation
  • the quantity of the chemical that may be introduced
  • the location(s) at which the commercial evaluation (use) may occur
  • any other condition reasonably necessary to manage any risks (or uncertainty regarding the risks) to human health and/or the environment.

The introducer would be required to:

  • apply only for the introduction volume and duration that is needed to conduct the commercial evaluation and provide adequate justification to support the purpose of the introduction, volume and duration
  • show that the risks to human health and the environment can be adequately managed
  • this includes known risks as well as the risk arising from the uncertainty of the hazards of the chemical.

Much of the above information will be included in primary legislation (and/or has already been consulted in previous consultation papers), but has been included here to provide context to the items discussed below.

Additional information that will be included in delegated legislation (and associated guidance materials and/or on the approved application form), relates to the applicable introduction volume application limit and the information requirements for an application for a commercial evaluation authorisation.

The introduction volume application limit would in general be 10 tonnes for the period of the commercial evaluation authorisation (i.e. up to 4 years), unless it could be demonstrated through additional justification that a higher volume was required. In this case, additional information requirements apply (see below for further details).

8.2 Information requirements

The information requirements outlined below are required to:

  • show that the proposed chemical introduction meets the requirements for the commercial evaluation authorisation pathway
  • ensure we receive enough information to enable the imposition of conditions to manage any potential risks, noting that a detailed risk assessment will not be conducted.

Chemical identity

  • Proper chemical name, i.e. CAS name and/or IUPAC name.
  • CAS registry number (if available).
  • Proposed AICIS approved chemical name (if relevant).
  • Common or trade name (if available).
  • Synonyms (if available).
  • Structural formula.
  • Molecular weight or molecular weight range.
  • If the chemical is a UVCB, the introducer must provide us with enough information to describe the chemical and provide the details of immediate precursors/natural sources.
  • Whether the chemical contains nanoscale particles.
  • Whether the chemical is or contains a GM product.

Introduction and evaluation details

  • Mode of introduction (import or manufacture).
  • Introduction volume for the purposes of commercial evaluation.
  • Proposed duration of commercial evaluation.
  • Proposed end use for the chemical.
  • Details to substantiate that the introduction is for commercial evaluation purposes, including (but not limited to):
    • purpose of the evaluation (what specifically is being evaluated)
    • description/plan of the evaluation/trials to be conducted
    • justification for the proposed volume and duration.
  • Identification of sites at which manufacture, reformulation and/or evaluation will occur.
  • Details of any previous applications by the applicant(s) for the same chemical.
  • Details of any known assessments of the chemical by other national or international regulatory agencies (e.g. agency and year).

Matters relevant to human health and the environment

  • A summary of any known hazards to human health and the environment (substantiated, for example, through the provision of a Safety Data Sheet on the chemical and/or introduced product, if available and/or product label, if available).
  • A list of any available toxicological and ecotoxicological study reports (reports only provided to us on request).
  • Details relevant to worker exposure, including:
    • categories of workers who will handle the chemical
    • the form (e.g. powder, solution etc.) and concentration of the chemical that each category of worker will handle
    • the nature of the work to be done by each category of workers
    • any controls (including engineering, PPE and administrative) that will be in place to prevent worker exposure to the chemical.
  • Confirmation that the chemical will not be made available to the public at any time on its own, in combination with other chemicals or in an article.
  • Where use of the chemical will result in (treated) environmental release greater than 100 kg/annum, information on the likely timeframe for the release for each physical location.
  • e.g. if the chemical will be predominantly released to a single sewage system, the timescale, weeks/months/years, over which the release is expected to occur.

Additional requirements for applications for introduction volumes exceeding 10 tonnes

  • Details to substantiate why the evaluation could not be conducted using an introduction volume ≤10 tonnes (including quantitative details, e.g. volume/test evaluation, number of evaluations required).
  • Details of how the users plan to mitigate release of the chemical to the environment.
  • Modelled data on fate and ecotoxicity (if possible, based on structural considerations).

8.3 Example scenarios

Table 20 provides some examples of scenarios, with specific activities that generally would and would not be considered to meet the proposed commercial evaluation authorisation criteria.

Table 20  – Example activities that would and would not meet the commercial evaluation authorisation criteria.
Example ScenariosActivities that would meet commercial evaluation authorisation criteriaActivities that would not meet commercial evaluation authorisation criteria
Introduction of a chemical for use in coatings
  • formulation processes (trial/optimise)
  • application conditions/techniques/surfaces (trial/optimise)
  • weather testing
  • test marketing11 (sale of formulated coatings to a limited number of potential (industrial) customers).
  • the chemical, formulated coatings (e.g. for DIY use) or articles to which the coating has been applied being made available to the general public (including during weather testing)
  • release of the chemical to the environment without prior treatment
  • uncontrolled use in the workplace.
Introduction of a chemical for use in inks
  • formulation processes (trial/optimise)
  • test marketing and/or to test application conditions/techniques/surfaces (sale of formulated inks to a limited number of potential (industrial) customers).
  • the chemical, formulated inks or articles to which the coating has been applied (e.g. printed posters/flyers/consumer labels) being made available to the general public
  • release of the chemical to the environment without prior treatment
  • uncontrolled use in the workplace.
Introduction of a chemical for use as an additive in fuel
  • formulation processes (trial/optimise)
  • test marketing and/or for efficiency/quality testing (sale of formulated fuels to a limited number of potential (industrial) customers).
  • the chemical, formulated fuels (e.g. for cars/retail sale) or vehicles containing the fuels (e.g. buses/marine) being made available to the general public
  • release of the chemical to the environment without prior treatment (treatment includes combustion to form simple molecules of carbon, hydrogen and oxygen)
  • uncontrolled use in the workplace.
Introduction of a chemical for use in mining
  • formulation processes (trial/optimise)
  • test marketing and/or for efficiency/quality testing, including where the chemical will become irreversibly bound within an inert matrix during use, e.g. in hardened cement (sale of formulated products to a limited number of potential (industrial) customers).
  • the chemical, formulated products or articles containing the chemical being made available to the general public
  • release of the chemical to the environment without prior treatment (e.g. chemicals used in drilling muds for onshore/offshore drilling operations unless all of the chemical was being collected and safely disposed of)
  • uncontrolled use in the workplace.

11 Test marketing, with respect to a chemical or product containing a chemical, means distribution to no more than a defined number of potential customers to explore market capability in a competitive situation before broader distribution in commerce.

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Are the types of activities that would and would not meet the commercial evaluation criteria clear?

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Next - Part 9: Ban on the use of new animal test data for cosmetic ingredients

Part 9: Ban on the use of new animal test data for cosmetic ingredients

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The use of animal test data to support the introduction of cosmetic chemicals is decreasing. Cheaper and equally reliable non-animal alternatives have become increasingly available since the introduction of a ban in the European Union (EU). The broader reforms further encourage the use of these alternative methods to support the introduction of chemicals onto the Australian market, through the information acceptable for categorisation and assessment (see Supporting material).

The Australian Government announced a package of initiatives to ban cosmetic testing on animals. The ban will improve animal welfare in Australia while maintaining Australia’s strong human health and environmental protection standards.

As a part of implementing this policy, a national ban on the use of new animal test data to support the introduction of chemicals used exclusively as cosmetic ingredients will be introduced through the new Industrial Chemicals Bill. This will mean that animal test data produced after 1 July 2018 cannot be used to meet the information requirements for categorisation or assessment of unlisted chemical introductions, where the only end use is cosmetics.

The ban also seeks to align its regulatory approach with those taken internationally, in particular the EU. The EU Cosmetics Regulation prohibits the use of animal test data to support the introduction of a cosmetic product onto the market. However, in limited circumstances animal test data is permitted to protect workers and the environment under the Registration, Evaluation, Authorisation and Restriction of Chemicals regulation (REACH).

To maintain current levels of human health and environment protection and align with the EU, it is proposed that the rules accompanying the new legislation will provide for limited circumstances where data may need to be considered to protect human health and the environment. These protections would be:

Human health

If animal test data produced after 1 July 2018 was generated for other purposes (e.g. for compliance with overseas chemical regulations) and showed that the chemical was potentially hazardous to human health, this information may need to be considered in categorising the chemical, and submitted to AICIS if categorised as Assessed.  This protection prevents an introducer from ignoring adverse information that is already available to them. It is similar to the EU, where manufacturers cannot produce animal test data for the EU, but also cannot ignore existing data.

Environment

If animal test data produced after 1 July 2018 was to assess environmental hazards, it could be used for categorisation or submitted to AICIS as part of an assessment certificate application. This would apply only where there were no validated non-animal alternatives. This protection would be aligned with the situation in the EU under REACH.

Have your say

What are your views on the proposed limited circumstances in which animal test data would be permitted to protect human health and the environment?

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Next - Part 10: Other matters

Part 10: Other matters

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The following links take you to various parts of this section.

10.1 Prescribed bodies for consultation

As discussed in previous consultation papers, the primary legislation will set out circumstances where the Executive Director must consult with bodies prescribed in delegated legislation (“prescribed bodies”).

Generally, this obligation to consult will arise when the Director:

  • is making a decision that may have regulatory impact, or
  • has made a decision, which will lead to action with regulatory impact.

Example

We assess a chemical. We conclude that the risks it poses are unmanageable. This conclusion will lead to one of the following actions:

  • we will refuse the assessment certificate (in the case of chemicals not on the Inventory and categorised as Assessed), or
  • we will remove the chemical from the Inventory (in the case of an evaluation of a listed chemical initiated by the Director), or
  • We will add or change the condition of introduction on the Inventory.

Before any final decision and action, the Executive Director will need to consult with the relevant prescribed bodies.

The relevant body will depend on the purpose and context of the consultation. Table 21 sets out the bodies that we propose to prescribe in the rules, noting that different bodies may be consulted for differing purposes.

Table 21 –  Proposed prescribed bodies.
Category Prescribed bodies
National risk managers
  • Department of the Environment and Energy (environmental risk management)
  • Safe Work Australia (workplace risk management)
  • Australian Competition and Consumer Commission (consumer products risk management)
  • Therapeutic Goods Administration – Delegate of the Secretary of the Department of Health for chemicals scheduling, and the scheduling secretariat (public health risk management)
  • Attorney-General’s Department (chemicals of security concern)
  • National Transport Commission (transport of chemicals)
Other national authorities
  • Office of the Gene Technology Regulator
  • National Health and Medical Research Council
  • Food Standards Australia & New Zealand
  • Clean Energy Regulator
State/territory risk managers
  • Environment protection bodies
    • ACT EPA
    • NSW EPA
    • NT EPA
    • Department of Environment and Heritage Protection, QLD
    • EPA SA
    • EPA Tasmania
    • EPA Victoria
    • EPA WA
  • Departments of Health (for scheduled substances – public health)
    • Department of Health WA
    • Department of Health and Human Services (Victoria)
    • Department of Health and Human Services Tasmania
    • Department for Health and Ageing SA
    • Queensland Health
    • Department of Health NT
    • Department of Health NSW
    • Department of Health ACT
  • Work Health and Safety bodies
    • WorkSafe WA
    • WorkSafe Victoria
    • WorkSafe Tasmania
    • SafeWork SA
    • Workplace Health and Safety Queensland, Office of Industrial Relations
    • NT WorkSafe
    • SafeWork NSW
    • WorkSafe ACT

Some bodies may be prescribed for a number of functions. For example the Department of Environment and Energy may be consulted in their capacity as any one of the following:

  • administering the Ozone Protection and Synthetic Greenhouse Gas Management Act (1989)
  • administering the Environment Protection and Biodiversity Conservation Act (1999)
  • administering the Fuel Quality Standards Act (2000) - currently the Department of the Environment and Energy
  • administering the Hazardous Waste (Regulation of Exports and Imports) Act (1989)
  • leading international engagement on the Stockholm Convention on Persistent Organic Pollutants, Rotterdam Convention, Minamata Convention, Basel Convention, Montreal Protocol, and Kyoto Protocol
  • future administration of the proposed legislation enacting the National Standard for environmental risk management of industrial chemicals.

10.2 Prescribed bodies for disclosure of confidential business information (CBI)

Consultation Paper 4 outlined a framework for protecting the confidentiality of information. This included full chemical identity, detailed end use, and other commercial information such as sites, concentrations and formulation processes.

This framework is included in the primary legislation and gives us authorisation to disclose information, including CBI, to:

  • national and state/territory government agencies, including risk management agencies (with legislated obligations for receiving agencies to maintain confidentiality)
  • a national regulatory authority of  another country, or an international organisation, with which Australia has co-operative arrangements
  • where necessary for Australia to meet its obligations under international conventions, and/or
  • by order of a court.

We propose that the national and state/territory bodies listed as prescribed bodies for risk management consultation also be prescribed in delegated legislation for CBI disclosure purposes.

The legislation will include obligations on any receiving body to maintain confidentiality.

In regards to national regulatory authorities of other countries, or other international organisations, the importance of having confidentiality maintained by the receiving organisation is paramount.

For this reason, we propose that the only organisations that are prescribed for this will be those with whom we have formal bilateral arrangements that have explicit terms requiring CBI protection.  Organisations meeting this requirement are:

  • Environment Canada
  • Health Canada
  • New Zealand EPA
  • European Chemicals Agency (ECHA)
  • US EPA.

10.3 Definitions to be made in delegated legislation

The primary legislation will include definitions of terms used in the Act.  Some definitions will be able to be supplemented by delegated legislation, by adding to or removing from the primary definition.

Article – exclusion of particles

The primary legislation makes it clear that it is the chemicals released from articles that are regulated by us, rather than the articles themselves. It also includes a definition of article.  We propose that delegated legislation will be able to supplement the definition of article. This will include the exclusion of particles and fluids.  Particles and fluids will be considered industrial chemicals (if they have an industrial use).

We propose to use the common definition of ‘fluids’ to inform this term in delegated legislation.

We propose to define ‘particle’ in line with the International Organization for Standardization (ISO), as a “minute piece of matter with defined physical boundaries” (ISO/TS 27687:2008)12.

12 Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, page 130, accessed 24 April 2017.

Industrial chemical – exclusion of radioactive chemicals

The primary definition of ‘industrial chemical’ will allow for certain chemicals to be excluded in the delegated legislation. We propose to exclude ‘radioactive chemicals’, which is consistent with the current ICNA Act (which excludes them from the definition of ‘chemical’).

We propose to define this term in alignment with the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) definition, as follows:

  • “radioactive chemical means a controlled material as defined in the Australian Radiation Protection and Nuclear Safety Act 1998 and the Exempt Dealings of the Australian Radiation Protection and Nuclear Safety Regulations 1999”.

10.4 Annual declaration by registrants

Under primary legislation, registrants will have to make an annual declaration to us about all chemicals introduced during a registration year.  Delegated legislation will set out what has to be declared. We intend this declaration to present the minimum regulatory burden required to provide the information we need to fulfil our legislative mandate, both in terms of the amount of information needed, and how to provide it (automated, pre-populated). We propose that annual declarations will require:

  • a declaration about Exempted introductions, i.e. whether such introductions have occurred, and confirming relevant criteria are satisfied (tick boxes)
  • a declaration about Reported introductions, i.e. confirming relevant criteria are satisfied (tick box)
  • a declaration about the Assessed and/or Inventory status of any other introductions (tick box)
  • a declaration about information requirements i.e. confirming post-assessment obligations and mandatory calls for information requirements have been met (tick box).

Next - Attachment A: Introductions of chemicals that are comparable to listed chemicals

Attachment A: Introductions of chemicals that are comparable to listed chemicals

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The Inventory relies on the system used by the Chemical Abstracts Service (CAS) for both nomenclature – Chemical Abstracts Index Name (CAS name), and identification number – CAS Registry Number (CAS number).

When 2 chemicals have different CAS numbers, they are generally regarded as being different chemicals. However, there are a number of situations where the same chemical is represented by multiple CAS identifiers and where only one CAS identifier is on the Inventory.

In some situations the Executive Director may decide that the CAS identifier not on the Inventory describes the chemical on the Inventory. In these cases the CAS identifier not on the Inventory can be added to the listing on the Inventory using the ‘minor variation’ provision of the new Act. For example:

  • The system of assigning a Color Index (CI) identifier to pigments and dyes often results in two CAS identifiers for the same chemical. For example “C.I. Reactive Yellow 37 (CAS RN 12237-16-0)” describes the CI identifier while another CAS identifier (CAS RN 85940-63-2) describes the chemical structure of the dye.
  • Polymers can be named according to the reactants used to form them (‘source-based representation’) or according to the final structure of the polymer (’structure-based representation’).This practice results in multiple CAS identifiers for the same chemical.

In other situations the Executive Director may decide that the CAS identifier not on the Inventory does not describe the chemical on the Inventory but is comparable to the listed chemical. In these situations the chemical with the CAS identifier not on the Inventory may be introduced under the Exempted category. For example:

  • polymers that are substantially the same because they meet a modified version of the current ‘2% rule’
  • extracts from two different species of plants that are deemed to be botanically equivalent, e.g. Chamomilla recuitita (matricaria) ext. (84082-60-0) and Oils, chamomile, German (8002-66-2).

This will be implemented in the delegated legislation by:

  • prescribing the criteria for a modified 2% rule for polymers
  • listing the chemicals in the delegated legislation that are comparable to specified listed chemicals.

To be eligible for categorisation as Exempted, the introduction of these chemicals must also meet the terms of the listing for the specified listed chemical.

Polymers meeting a 2% rule

Polymers that meet the below criteria (i.e. a modified version of the current ‘2% rule’) will be comparable to chemicals listed on the Inventory.

A polymer that is substantially the same as a polymer listed on the Inventory in that:

  • it contains all the monomers and reactants in the listed polymer, and
  • any additional monomers and reactants in the unlisted polymer constitute no greater than 2% by weight of the unlisted polymer, and
  • any such additional monomers and reactants that constitute no greater than 2% weight of the unlisted polymer must not be known or suspected of being:
    • persistent, bioaccumulative and toxic (PBT) according to the national PBT criteria, or
    • chemicals containing a sequence of one or more fully fluorinated carbon atoms, or
    • chemicals that contain mercury, lead, cadmium or arsenic.

The criteria are similar to the current “2% rule”, with the exception of the third dot point, relating to the presence of certain monomers and reactants. We consider the addition of this requirement to be consistent with a risk-based and proportionate approach, as it will ensure appropriate oversight for polymers that may be of high hazard. The presence of these monomers and reactants at low concentrations and/or low volumes warrant further consideration.

Consideration of whether the additional monomers and reactants are of the types outlined in the third dot point would not require full hazard characterisation of each monomer and reactant. Rather, considerations would be based on what is known about the monomers and reactants in terms of structural considerations, existing hazard classifications, modelling, etc.

If a polymer meets the requirements of the “2% rule” and the introducer decides that they would like to categorise its introduction as Exempted, they would be able to decide if the polymer name used for the purposes of their introduction into Australia contains the monomers and reactants that are present at ≤ 2%.

If a polymer does not meet the 2% rule on the basis of monomers or reactants of the types outlined in the third dot point, the polymer must be categorised in accordance with the risk matrices. In considering the hazard information requirements necessary for categorisation, any hazards of these monomers and reactants must be appropriately accounted for.

Example

An introducer intends to introduce a polymer (Polymer 1) that consists of 4 monomers in the following proportions:

  • monomer A: 70%
  • monomer B: 20%
  • monomer C: 8.5%
  • monomer D: 1.5% (a long chain fluorinated chemical that is a known precursor of PFOS).

Polymer of A, B and C (Polymer 2) is listed on the Inventory.

The proposed introduction volume is 10,000 kg per annum.

Outcome

Monomer D is present at ≤2% but is a fluorinated chemical containing a sequence of one or more fully fluorinated carbon atoms. Thus, Polymer 1 cannot be an Exempted chemical and requires categorisation.


Next - Attachment B: Polymer of low concern criteria

Attachment B: Polymer of low concern criteria

In Consultation Paper 3, we outlined an initial proposal to exclude certain fluorinated polymers from being PLCs under the new legislation. This was closely based on the US EPA Polymer Exemption Rule, which excludes many perfluorinated polymers (those containing certain perfluoroalkyl moieties consisting of a CF3- or longer chain length). This initial proposal has now been further refined and simplified. The current proposal is that the following type of polymers cannot be PLCs:

A polymer that contains a sequence of one or more fully fluorinated carbon atoms.

This is consistent with current practice where polymers containing a perfluorinated group cannot be considered to be PLCs. It is also consistent with the US Polymer Exemption Rule. This additional criterion should ensure that polymers for which any uncertainty or concerns exist will be either Reported to AICIS or Assessed rather than Exempted, thus allowing for appropriate oversight.

Stability criterion

Clarification of the polymer stability criterion for the purposes of determining if a polymer is a PLC. The definition of stable polymer has been revised to be harmonised with the definitions used by US and Canada.

Reactive functional groups (RFGs)

As outlined in Consultation Paper 3, the level of concern of certain reactive functional groups has been changed so it more closely aligns with USA and Canada. Table 24 lists the RFGs per level of concern.

There have also been a few additions to the RFGs lists. The following RFGs have been added to the low concern RFG list:

  • imidazolidinone
  • imides
  • organic phosphate esters.

These groups have previously been determined to be low concern reactive functional groups (and have been communicated to stakeholders through our website), although they are not currently listed in the Regulations.

The following functional groups were added to the high concern RFG list:

  • azo groups
  • disulfides
  • trithiocarbonates

These groups are known to be of high concern. Their addition clarifies the outcomes for polymers containing these functional groups (even though, without listing, they would default to being of high concern). This is particularly important for the new framework, where introducers will be required to self-determine if their polymer is a PLC.

Polyesters

Additions have been made to the list of prescribed reactants for polyesters, based on assessments undertaken jointly by NICNAS, US EPA, Health Canada and Environment Canada as part of a project under the OECD Clearing House for New Chemicals. These changes are consistent with Consultation Paper 3. Table 23 lists the revised prescribed reactants.

Revised PLC criteria

Polymer of low concern, as detailed further in Table 22, means a polymer that either:

  • has a number average molecular weight that is greater than or equal to 1,000 Da (as outlined below) or
  • is made from a prescribed reactant and has molecules that contain 2 or more carboxylic acid ester linkages, one or more of which links internal monomer units together (Table 23 lists the revised prescribed reactants).

A polymer of low concern has the following characteristics:

  • has a low charge density (defined below)
  • is stable (defined below)
  • does not contain a sequence of one or more fully fluorinated carbon atoms
  • contains at least 2 atomic elements from the list prescribed below
  • does not contain (except as impurities) atomic elements other than those from the list prescribed below
  • is not known to have any of the hazard characteristics in Hazard Bands B-D for human health or Hazard Bands B-E for environment.

Number-average molecular weight (NAMW)

Criteria for 1,000 ≤ NAMW < 10,000 Daltons

The polymer must:

a.  have less than 10% by mass of molecules with molecular weight that is less than 500 Da

b.  have less than 25% by mass of molecules with molecular weight that is less than 1,000 Da.

In addition, if the polymer includes:

  • moderate concern reactive functional groups, and does not include high concern reactive functional groups
  • high concern reactive functional groups
    • it must have a combined functional group equivalent weight of at least 5,000, calculated based on all moderate and high concern reactive functional groups present in the polymer.

Note that the level of concern for certain reactive functional groups is shown in Table 24.

Criteria for NAMW ≥ 10,000 Daltons

The polymer must:

(a)   have less than 2% by mass of molecules with molecular weight that is less than 500 Da; and

(b)   have less than 5% by mass of molecules with molecular weight that is less than 1,000 Da.

Water absorbing polymers

In addition, a polymer with NAMW ≥ 10,000 Da must not be capable of absorbing its own weight in water.

Table 22 – Characteristics of a polymer of low concern.
CharacteristicDefinition
Has a low charge density

A polymer has a low charge density if:

  • it is both:
    • not cationic
    • not likely to become cationic in an aquatic environment that has a pH value greater than 4 and less than 9
  • it is a solid that is:
    • not soluble or dispersible in water
    • to be used only in its solid phase
  • for a polymer that includes 1 or more cationic groups, the total combined functional group equivalent weight of any cationic group is at least 5,000.
Is stable

A polymer cannot be a PLC if it is designed or can be expected  to substantially degrade, decompose or depolymerise, including polymers that substantially degrade, decompose or depolymerise after manufacture and end use, even though they are not intended to do so.

Degradation, decomposition and depolymerisation mean the types of chemical changes that break down a polymer into simpler, smaller substances, through processes including but not limited to oxidation, hydrolysis, attack by solvents, heat, light and microbial action.

Does not contain a sequence of one or more fully fluorinated carbon atomsN/A.
Contains at least 2 atomic elements from the list outlined in the definition column
  • Carbon
  • Hydrogen
  • Nitrogen
  • Oxygen
  • Silicon
  • Sulfur.
Does not contain (except as impurities) atomic elements other than those from the list outlined in the definition column.
  • Aluminium as the monatomic counterion Al3+
  • Bromine as the monatomic counterion Br
  • Bromine covalently bound to carbon
  • Calcium as the monatomic counterion Ca2+
  • Carbon
  • Chlorine as the monatomic counterion Cl
  • Chlorine covalently bound to carbon
  • Fluorine covalently bound to carbon
  • Hydrogen
  • Iodine as the monatomic counterion I
  • Iodine covalently bound to carbon
  • Magnesium as the monatomic counterion Mg2+
  • Nitrogen
  • Oxygen
  • Potassium as the monatomic counterion K+
  • Silicon
  • Sodium as the monatomic counterion Na+
  • Sulfur
  • Less than 0.2% (by weight) of any combination of the following atomic elements:
    • Boron
    • Copper
    • Iron
    • Lithium
    • Manganese
    • Nickel
    • Phosphorus
    • Tin
    • Titanium
    • Zinc
    • Zirconium.
Table 23 - List of prescribed reactants
Part 1 Di and tri basic acids
ItemSubstanceCAS number
1011,2‑Benzenedicarboxylic acid88‑99‑3
1021,3‑Benzenedicarboxylic acid121‑91‑5
1031,3‑Benzenedicarboxylic acid, dimethyl ester1459‑93‑4
1041,4‑Benzenedicarboxylic acid100‑21‑0
1051,4‑Benzenedicarboxylic acid, diethyl ester636‑09‑9
1061,4‑Benzenedicarboxylic acid, dimethyl ester120‑61‑6
1071,2,4‑Benzenetricarboxylic acid528‑44‑9
108Butanedioic acid110‑15‑6
109Butanedioic acid, diethyl ester123‑25‑1
110Butanedioic acid, dimethyl ester106‑65‑0
1112‑Butenedioic acid (E)‑110‑17‑8
111A1,4‑Cyclohexanedicarboxylic acid1076‑97‑7
112Decanedioic acid111‑20‑6
113Decanedioic acid, diethyl ester110‑40‑7
114Decanedioic acid, dimethyl ester106‑79‑6
115Dodecanedioic acid693‑23‑2
116Fatty acids, C18‑unsaturated, dimers61788‑89‑4
116A2,5‑Furandione, dihydro‑108‑30‑5
117Heptanedioic acid111‑16‑0
118Heptanedioic acid, dimethyl ester1732‑08‑7
119Hexanedioic acid124‑04‑9
120Hexanedioic acid, dimethyl ester627‑93‑0
121Hexanedioic acid, diethyl ester141‑28‑6
121A5‑Isobenzofurancarboxylic acid, 1,3‑dihydro‑1,3‑dioxo‑552‑30‑7
121B1,3‑Isobenzofurandione85‑44‑9
122Nonanedioic acid123‑99‑9
123Nonanedioic acid, dimethyl ester1732‑10‑1
124Nonanedioic acid, diethyl ester624‑17‑9
125Octanedioic acid505‑48‑6
126Octanedioic acid, dimethyl ester1732‑09‑8
127Pentanedioic acid110‑94‑1
128Pentanedioic acid, dimethyl ester1119‑40‑0
129Pentanedioic acid, diethyl ester818‑38‑2
130Undecanedioic acid1852‑04‑6
131Unsaturated fatty acids, C18, dimers, hydrogenated68783‑41‑5
Table 23 - List of Prescribed reactants
Part 2 Modifiers
ItemSubstanceCAS number
201Acetic acid, 2,2´‑oxybis‑110‑99‑6
2021‑Butanol (other than 1‑butanol that is used to manufacture a polyester with maleic or fumaric acid)71‑36‑3
203Cyclohexanol108‑93‑0
204Cyclohexanol, 4,4´‑(1‑methylethylidene)bis80‑04‑6
204AEthanol64‑17‑5
205Ethanol, 2‑(2‑butoxyethoxy)‑112‑34‑5
2061‑Hexanol111‑27‑3
206AMethanol67‑56‑1
207Methanol, hydrolysis products with trichlorohexylsilane and trichlorophenylsilane72318‑84‑4
2081‑Phenanthrenemethanol, tetradecahydro‑1,4a‑dimethyl‑7‑(1‑methylethyl)‑13393‑93‑6
209Phenol, 4,4´‑(1‑methylethylidene)bis‑, polymer with 2,2´‑[(1‑methylethylidene)bis(4,1‑phenyleneoxymethylene)]bis[oxirane]25036‑25‑3
209A1‑Propanol, 2‑methyl‑78‑83‑1
210Siloxanes and Silicones, dimethyl, diphenyl, polymers with phenyl silsesquioxanes, methoxy‑terminated68440‑65‑3
211Siloxanes and Silicones, dimethyl, methoxy phenyl, polymers with phenyl silsesquioxanes, methoxy‑terminated68957‑04‑0
212Siloxanes and Silicones, methyl phenyl, methoxy phenyl, polymers with phenyl silsesquioxanes, methoxy‑ and phenyl‑terminated68957‑06‑2
213Silsesquioxanes, phenyl propyl68037‑90‑1
Table 23 - List of Prescribed reactants
Part 3 Monobasic acids and natural oils
ItemSubstanceCAS number
301Benzoic acid 65‑85‑0
302Canola oil 120962‑03‑0
302ACastor oil 8001‑79‑4
302BCastor oil, dehydrated 64147‑40‑6
302CCastor oil, dehydrated, polymerised 68038‑02‑8
303Coconut oil 8001‑31‑8
303ACoconut oil, hydrogenated 84836‑98‑6
304Corn oil 8001‑30‑7
304ACorn‑oil fatty acids 68308‑50‑9
305Cottonseed oil 8001‑29‑4
306Dodecanoic acid 143‑07‑7
307Fats and glyceridic oils, anchovy 128952‑11‑4
308Fats and glyceridic oils, babassu 91078‑92‑1
309Fats and glyceridic oils, herring 68153‑06‑0
310Fats and glyceridic oils, menhaden 8002‑50‑4
311Fats and glyceridic oils, sardine 93334‑41‑9
312Fats and glyceridic oils, oiticica 8016‑35‑1
312AFatty acids, C8‑10 68937‑75‑7
312BFatty acids, C14‑18 and C16‑18‑unsaturated 67701‑06‑8
313Fatty acids, C16‑18 and C18‑unsaturated 67701‑08‑0
314Fatty acids, castor‑oil 61789‑44‑4
315Fatty acids, coco 61788‑47‑4
316Fatty acids, dehydrated castor‑oil 61789‑45‑5
317Fatty acids, linseed oil 68424‑45‑3
317AFatty acids, olive‑oil 92044‑96‑7
318Fatty acids, safflower oil 93165‑34‑5
319Fatty acids, soya 68308‑53‑2
320Fatty acids, sunflower oil 84625‑38‑7
321Fatty acids, sunflower‑oil, conjugated 68953‑27‑5
322Fatty acids, tall‑oil 61790‑12‑3
323Fatty acids, tall‑oil, conjugated 
324Fatty acids, vegetable oil 61788‑66‑7
324AFish oil 8016‑13‑5
325Glycerides, C16‑18 and C18‑unsaturated 67701‑30‑8
326Heptanoic acid 111‑14‑8
326AHexadecanoic acid 57‑10‑3
326B9‑Hexadecenoic acid, (9Z)‑ 373‑49‑9
327Hexanoic acid 142‑62‑1
328Hexanoic acid, 3,5,5‑trimethyl 3302‑10‑1
328AHexanoic acid, 3,3,5-trimethyl 23373-12-8
329Linseed oil 8001‑26‑1
330Linseed oil, oxidised 68649‑95‑6
330ALinseed oil, polymerised 67746‑08‑1
331Nonanoic acid 112‑05‑0
331AOctadecanoic acid 57‑11‑4
331B9‑Octadecenoic acid (9Z)‑ 112‑80‑1
331C9,12‑Octadecadienoic acid (9Z,12Z)‑ 60‑33‑3
332Oils, Cannabis 
333Oils, palm kernel 8023‑79‑8
334Oils, perilla 68132‑21‑8
335Oils, walnut 8024‑09‑7
335AOlive oil 8001‑25‑0
336Safflower oil 8001‑23‑8
337Soybean oil 8001‑22‑7
338Sunflower oil 8001‑21‑6
339Tung oil 8001‑20‑5
Table 23 - List of Prescribed reactants
Part 4 Polyols
ItemSubstanceCAS number
4011,3‑Butanediol107‑88‑0
4021,4‑Butanediol110‑63‑4
4031,4‑Cyclohexanedimethanol105‑08‑8
4041,2‑Ethanediol107‑21‑1
405Ethanol, 2,2´‑oxybis‑111‑46‑6
4061,6‑Hexanediol629‑11‑8
4071,3‑Pentanediol, 2,2,4‑trimethyl‑144‑19‑4
4081,2‑Propanediol57‑55‑6
408A1,3‑Propanediol504‑63‑2
4091,3‑Propanediol, 2,2‑bis(hydroxymethyl)‑115‑77‑5
4101,3‑Propanediol, 2,2‑dimethyl‑126‑30‑7
4111,3‑Propanediol, 2‑ethyl‑2‑(hydroxymethyl)‑77‑99‑6
4121,3‑Propanediol, 2‑(hydroxymethyl)‑2‑methyl77‑85‑0
4131,3‑Propanediol, 2‑methyl2163‑42‑0
4141,2,3‑Propanetriol56‑81‑5
4151,2,3‑Propanetriol, homopolymer25618‑55‑7
4162‑Propen‑1‑ol, polymer with ethenylbenzene25119‑62‑4

The following sets out substances that are derivatives of substances set out in parts 1 and 3.

Table 23 - List of Prescribed reactants
Part 5 Derivatives
ItemSubstance
1A diethyl or triethyl ester of a substance listed in Part 1.
2A dimethyl or trimethyl ester of a substance listed in Part 1.
3A methyl ester of a substance listed in Part 1 or 3.
4An anhydride of a substance listed in Part 1 or 3.
5An ethyl ester of a substance listed in Part 1 or 3.
Table 24 - List of reactive functional groups
Low concern reactive functional groups
ItemReactive functional group
1Aliphatic hydroxyls.
2Blocked isocyanates (including ketoxime‑blocked isocyanates).
3Butenedioic acid groups.
4Carboxylic acids.
5Conjugated olefinic groups contained in naturally occurring fats, oils and carboxylic acids.
6Halogens (except reactive halogen‑containing groups such as benzylic or allylic halides).
6AImidazolidinone groups.
6BImides.
6COrganic phosphate esters.
7Thiols.
8Unconjugated nitriles.
9Unconjugated olefinic groups considered ’ordinary‘ (that is, unconjugated olefinic groupsnot specifically activated by being part of a larger functional group or by other activating influences).
Table 24 - List of reactive functional groups
Moderate concern reactive functional groups
ItemReactive functional group
1Acid anhydrides.
2Acid halides.
3Aldehydes.
4Alkoxysilanes (with alkoxy greater than C2‑alkoxysilane).
5Allyl ethers.
6Conjugated olefinic groups not contained in naturally occurring fats, oils and carboxylic acids.
7Cyanates.
8Epoxides.
9Hemiacetals.
10Imines (ketimines and aldimines).
11Methylol‑amides.
12Methylol‑amines.
13Methylol‑ureas.
14Unsubstituted positions ortho and para to phenolic hydroxyl.
Table 24 - List of reactive functional groups
High concern reactive functional groups
ItemReactive functional group
1Alkoxysilanes (with alkoxy of C1‑ or C2‑ alkoxysilane).
2Alpha lactones.
3Aziridines.
3AAzo groups.
4Beta lactones.
5Carbodi‑imides.
5ADisulfides.
6Halosilanes.
7Hydrazines.
8Hydrosilanes.
9Isocyanates.
10Isothiocyanates.
11Partially‑hydrolysed acrylamides.
12Pendant acrylates.
13Pendant methacrylates.
13ATrithiocarbonates.
14Vinyl sulfones or analogous compounds.
15Any other reactive functional group that is not a low concern reactive functional group or a moderate concern reactive functional group.

Next - Attachment C: Persistent bioaccumulative and toxic substances criteria

Attachment C: Persistent Bioaccumulative and Toxic substances criteria

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Persistent, Bioaccumulative and Toxic (PBT) chemicals are of particular concern to the environment. PBT chemicals persist for long periods, accumulate in biota and can give rise to toxic effects after a greater time and at a greater distance from the source than chemicals without PBT properties. Also concerning is that a cessation of emissions of these chemicals will not necessarily result in a reduction in concentration in the environment, that is, their effects following release may be irreversible. Australia is a Party to the Stockholm Convention on Persistent Organic Pollutants (POP) and has an obligation to prevent further production or release of POP-like substances, such as PBT chemicals.

For the substance to be considered persistent, bioaccumulative and toxic, it must meet all three hazard characteristics (P and B and T) of the National PBT Criteria. Chemicals deemed to be PBT may not be adequately addressed by traditional risk assessment methodologies.

The National PBT criteria are outlined in Table 25. Note that these are general criteria and may not be directly applicable to difficult to test substances such as some surfactants or inorganic chemicals.

Table 25 – PBT criteria.

Hazard characteristicEnvironmental medium (or compartment or trophic level)Indicators and numerical thresholds for positive hazard categorisation
PersistenceAirHalf-life in air (T½) ≥2 days
WaterHalf-life in water (T½) ≥60 days
SoilHalf-life in soil (T½) ≥6 months
SedimentHalf-life in sediment (T½) ≥6 months
BioaccumulationAquaticBAF ≥2000 or BCF ≥2000 or log Kow ≥4.2 (if BAF and BCF are not available)
Terrestriallog Koa >6 and log Kow ≥2
Food-chain bioaccumulation potentialBMF >1
Toxicity

Aquatic – Acute

Fish

Invertebrates

Algae or other aquatic plants

96 h LC50 ≤1 mg/L and/or

48 h EC50 ≤1 mg/L and/or

72 or 96 h ErC50 ≤1 mg/L.

Aquatic – Chronic

 

Fish

Invertebrates

Algae or other aquatic plants

Chronic NOEC or ECx ≤0.1 mg/L and/or

Chronic NOEC or ECx ≤0.1 mg/L and/or

Chronic NOEC or ECx ≤0.1 mg/L.

Note: BCF = bioconcentration factor; BAF = bioaccumulation factor; Kow = n-octanol/water partition coefficient; Koa = octanol/air partition coefficient; BMF = biomagnification factor; LC50 = concentration lethal to 50% of the population; E(r)C50(x) = concentration that has adverse effects to 50% of the population (or growth rate for algae); NOEC = No Observable Effect Concentration.


Next - Abbreviated terms

Abbreviated terms

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Abbreviations and their definitions
AbbreviationFull name / meaning
AICIS Australian Industrial Chemicals Introduction Scheme
APVMA Australian Pesticides and Veterinary Medicines Authority
ARPANSA Australian Radiation Protection and Nuclear Safety Agency
BAF Bioaccumulation factor
BCF Bioconcentration factor
CAS Chemical Abstracts Service
CAS RN CAS Registry Number
CBI Confidential business information
CEPA Canadian Environmental Protection Act, 1999
CP Consultation paper
Da Dalton (unified atomic mass unit)
DIY Do it yourself
EC European Commission
ECHA European Chemicals Agency
EC50 Median effect concentration
ECx Effect concentration at the given percentage
EU European Union
EU REACHEuropean Union’s regulation for Registration, Evaluation, Authorisation and Restriction of Chemical substances
ErC50 Medium effect concentration for growth rate
FGEW Functional group equivalent weight
GHS Globally Harmonised System of Classification and Labelling of Chemicals
GMO Genetically modified organism
GM productGenetically modified product
ICNA Act The Commonwealth Industrial Chemicals (Notification and Assessment) Act 1989
ISOInternational Organisation for Standardisation
KowOctanol/water partition coefficient
LC50 Median lethal concentration
IUPACInternational Union for Pure and Applied Chemistry
MW Molecular weight
NAMW Number average molecular weight
NICNAS National Industrial Chemicals Notification and Assessment Scheme
NMR Nuclear magnetic resonance spectroscopy
NOEC No-observed effect concentration
OECD Organisation for Economic Co-operation and Development
OECD WPMN OECD Working Party on Manufactured Nanomaterials
PLC Polymer of low concern
PBT Persistent bioaccumulative and toxic substance
PB Persistent and bioaccumulative substance
POPs Persistent organic pollutants
PPE Personal protective equipment
RFG Reactive functional group
RIS Regulation Impact Statement
SCCS Scientific Committee on Consumer Safety
TSCA The United States Toxic Substances Control Act, 1976
US United States of America
US EPA United States Environmental Protection Agency
UV Ultraviolet
UVCB Substance of unknown or variable composition, complex reaction products and biological materials
UV/EB cured inks Ultraviolet/electron beam cured inks

Next - Defined terms

Defined terms

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Are the definitions of terms to be included in delegated legislation (those marked with an *) clear and unambiguous?

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These definitions closely align with the equivalent OECD and other international regulatory definitions wherever possible. Terms with an adjacent asterisk (*) are proposed to be included in delegated legislation. Terms without an adjacent asterisk are not proposed to be included in delegated legislation, but may have a similarly defined term intended to be included in primary legislation (e.g. UVCB) and/or have just been included for the benefit of readers.

A list of terms and definitions
Term Meaning of term
*Agglomerate A collection of weakly bound particles, aggregates or mixtures of the two where the resulting external surface area is similar to the sum of the surface areas of the individual components.

*Aggregate

A particle comprising strongly bonded or fused particles where the resulting external surface area may be significantly smaller than the sum of calculated surface areas of the individual components.

Analogue

A chemical whose intrinsic physical-chemical, environmental or toxicological properties are likely to be similar to another chemical based upon a number of potential properties, including structural, physical-chemical and toxicological.

*Aquatic life

Fish, invertebrates and/or algae.

*Bioaccumulation potential

Refers to a bioconcentration factor of BCF ≥ 500 (or partition coefficient of log Kow ≥ 4.0 where BCF is not available). These threshold values are aligned with the GHS. For polymers, this means having ≥25% low molecular weight oligomeric species <1,000 Da and ≥10% low molecular weight oligomeric species <500 Da.
*Biochemical

A chemical, including a polymer, that is:

  • directly produced by living or once-living cells or cellular components or
  • a derivative or modification of a chemical referred to in paragraph (a) in which the original chemical remains substantially intact

Categorisation/Categorise/Categorised

Relates to the process and outcome of determining the appropriate chemical introduction category.
Characterisation GuideA guide to characterise the exposure and hazard information when you introduce an unlisted chemical into Australia.
Chemical A chemical or a polymer.
Chemical introduction category

One of six possible introduction categories for which the regulatory requirements for the introduction are described in the primary legislation. The possible categories include:

  • listed introductions
  • Exempted introductions
  • Reported introductions
  • Assessed introductions
  • commercial evaluation introductions
  • exceptional circumstances introductions.
*Contained import/export

Introduction of a chemical that:

  • is imported into Australia and the entire quantity is subsequently exported out of Australia and
  • does not undergo any form of treatment or processing during its time in Australia (i.e. the packaging in which the new chemical is contained remains unopened) and
  • remains the responsibility of the importer/exported at all times whilst it is in Australia.
Delegated legislationLegislation subordinate to the primary Industrial Chemicals legislation.
Exposure characterisation The consideration of the relevant exposure factors/details related to the introduction of the chemical. These factors/details include the annual introduction volume, release volume, concentration and use of the chemical and physico-chemical endpoints. Exposure characterisation contributes to the determination of both the human health and environment introduction categories. The factors/details AICIS requires to be informed about may vary dependent on the chemical introduction category (being commensurate with the predicted exposure) and/or the nature/class of the chemical.
*Functional group equivalent weight The ratio of the molecular weight to the number of occurrences of that functional group in the molecule. It is the weight of chemical that contains one formula-weight of the functional group.
Hazard characterisation The consideration of all available information on the relevant hazard characteristics of the chemical. This information includes the minimum information requirements for categorisation (if applicable for the Exposure Band) and the additional information constituting full hazard characterisation used to characterise the chemical as not hazardous (if applicable). Hazard characterisation contributes to the determination of both the human health and environment introduction categories. The level of hazard characterisation information required to be informed to AICIS may vary dependent on the chemical introduction category (being commensurate with the predicted exposure) and/or the nature/class of the chemical.
Hazard characteristics The established or potential hazardous properties of the chemical related to the nature of the chemical and its introduction. The possible hazard characteristics of chemicals for human health and environment (and/or uncertainties with respect to the hazards) are represented as hazard endpoints in the respective hazard band tables. The hazard characteristics with greatest uncertainty with respect to concern to, or effects on, human health or the environment are represented first. Consideration of the established absence of hazard characteristics forms the regulatory treatment of not hazardous chemicals.
High molecular weight polymer A polymer with NAMW≥ 1000 Da.
Information waivers Information on the chemical that may not be required for the purposes of categorising a chemical introduction, or for submitting an application for assessment, to AICIS. A waiver may be used to negate, replace, or supplement the corresponding information requirement. In many cases, the waivers vary with Exposure Band:
  • specified information waivers will apply for certain hazard and physico-chemical endpoints for the purposes of categorisation and when submitting applications for assessment
  • case-by-case information waivers will apply only when submitting applications for assessment.
*Intentional human exposure With respect to the end use of industrial chemicals, means deliberate placement of an industrial chemical or a product containing an industrial chemical directly in contact with any part of the human body as a result of its intended end use, including (but not limited to) end use in cosmetics, electronic cigarettes (e-cigarettes) and tattoo inks. Intentional human exposure will not include exposures that are incidental to the end use, including (but not limited to) exposure to household cleaning products and chemicals used to adjust the pH in swimming pools.
International pathway The introduction of a chemical for which an international risk assessment has been conducted by a prescribed international body, where the risk assessment meets the criteria for adoption of international standards and risk assessments by the Health portfolio. Acceptance by AICIS of the chemical introduction via this pathway enables the chemical to be introduced under the Reported chemical introduction category.
Introduction Of an industrial chemical means the importation, or the manufacture in Australia, of the industrial chemical.
*Introduction volume The total volume of chemical imported and manufactured by the introducer for all industrial uses during the specified period.
Listed introduction The introduction of a chemical that is listed on the Inventory and introduction is in accordance with the terms of the listing.
Low molecular weight polymer A polymer with NAMW <1000 Da.
Minimum information requirements The minimum amount of information needed to sufficiently determine the indicative risk of a chemical. The indicative risk informs the determination of the appropriate chemical introduction category.
*Mixture A combination of two or more industrial chemicals in which the chemicals do not react, but does not include a UVCB substance
*Number average molecular weight The arithmetic average (mean) of the molecular weight of all molecules in a polymer

*Ozone Depleting
Ozone Depleting Chemicals will be those chemicals (including volatile organic compounds) which meet the definition of Ozone Depleting Substances (ODSs) in the Montreal Protocol and Australia’s Ozone Protection and Synthetic Greenhouse Gas Management Act 1989.
*Persistent, Bioaccumulative and Toxic (PBT) Has the meaning as described in Attachment C.
*Polymer

A chemical that consists of:

  • molecules that are characterised by the sequence of one or more types of monomer units; and
  • molecules that are distributed over a range of molecular weights whose differences in the molecular weight are primarily attributable to differences in the number of monomer units; and
  • greater than 50% by weight of molecules having a sequence of at least three monomer units covalently bound to at least one other monomer unit or other reactant.

Where:

Monomer means a chemical that is capable of forming covalent bonds with two or more like or unlike molecules under the conditions of the relevant polymer‑forming reactions used for a particular process of polymer formation.

monomer unit means reacted form of a monomer in a polymer.

reactant, in respect of a polymer, means a chemical that is used in the polymer-forming reactions to become chemically a part of the polymer composition, and includes a monomer.

Other reactant means a molecule linked to one or more sequences of monomer units but which, under the conditions of the relevant reaction conditions used for the particular process cannot become a repeating unit in the polymer structure.

*Polymer of Low Concern Has the meaning as described in Attachment B.
*Reactive functional group Atoms or an associated group of atoms in a chemical that are intended or may reasonably be expected to undergo facile chemical reaction.
*Release factor The fraction of chemical released to all environmental compartments.
*Research and development

Introduction of an industrial chemical for the purpose of systematic investigation or research, by means of experimentation or analysis, other than test marketing.

  • With respect to determining the introduction category for human health, research and development does not include introduction:
  • of a chemical that is made available to the general public on its own, in combination with other chemicals or in an article or
  • involving uncontrolled use in the workplace or
  • of an industrial chemical at an introduction volume exceeding 100 kg/annum, unless the experimentation and analysis (excluding small-scale off-site testing) is being conducted at sites operated by a single user/business entity.
  • With respect to determining the introduction category for environment, research and development does not include introduction:
    • of an industrial chemical with a treated release volumeexceeding 100 kg/annum or
    • involving release of hazardous chemicals to landfill or sewer prior to treatment to render them no longer hazardous

Where:

Test marketing, with respect to a chemical or product containing a chemical, means distribution to no more than a defined number of potential customers to explore market capability in a competitive situation before broader distribution in commerce.

Uncontrolled use, in relation to workplace use, means use of the chemical with no control measures implemented to eliminate or minimise the risk.

*Stable polymer A polymer that is not designed or reasonably anticipated to substantially degrade, decompose or depolymerise.

Where:

Degradation, decomposition and depolymerisation mean the types of chemical changes that break down a polymer into simpler, smaller substances, through processes including but not limited to oxidation, hydrolysis, attack by solvents, heat, light and microbial action.
*Synthetic greenhouse gas Has the same meaning as in the Ozone Protection and Synthetic Greenhouse Gas Management Act 2000
*Treated release volume

The maximum volume of chemical expected to be released to the environment during the specified period:

  • following some form of treatment and/or
  • where treatment is not required because the chemical is released to the air in a dispersive manner from:
    • small-scale, consumer uses, including (but not limited to) aerosols
    • end use of volatile substances, where the release is incidental

where treatment means some form of intervention (including capture, destruction or irreversible transformation or disposal to landfill) to minimise release of a chemical into the environment.

Unlisted chemical introduction The introduction of a chemical that’s not listed on the Inventory. The primary introduction categories for these introductions are Exempted, Reported and Assessed.
UVCB

A substance that is any of the following:

  • a chemical of unknown or variable composition
  • a complex product of a chemical reaction
  • biological material, other than a whole animal or a whole plant.

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