Last update 29 July 2018
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The Australian Government has decided to reform the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to:
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:
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:
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:
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
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The Australian Government has decided to reform the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to:
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:
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.
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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:
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:
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.
Delegated legislation (as set out in Consultation Paper 5) | Characterisation Guide and guidance documents (as set out in supporting material) |
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Figure 2 Stakeholder consultation to date
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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:
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.
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.
| Exempted introductions | Reported introductions | Assessed introductions |
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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
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:
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:
To determine the human health introduction category, introducers must identify the:
This information gives the human health introduction category.
To determine the environment introduction category, an introducer must identify the:
This information gives the environment 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
We 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
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:
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
Go back to the start Part 3 Categorisation of chemical introductions
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).
Exposure Band | Criteria for human health Exposure Bands | |
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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 |
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2 |
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3 |
or
or
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or
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4 |
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5 |
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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.
Have your sayAre there any other use types that result in "intentional human exposure" that may be incidental to the end use? We would like to clarify whether these are or are not intended to be captured by the definition. |
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).
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.
Have your sayAre the criteria for determining the Exposure Bands for human health clear and unambiguous? |
Hazard Band | Criteria for human health hazard characteristics | Classifications under the GHS that will meet the criteria for the Hazard Band |
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D | Any of the following:
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C | Any of the following:
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B | Any of the following:
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A |
| - |
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.
Have your sayAre the criteria for determining the Hazard Bands for human health clear and unambiguous? |
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
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:
If a chemical introduction is in Exposure Band 3 for human health, the chemical introduction category will be:
If a chemical introduction is in Exposure Band 4 or 5 for human health, the chemical introduction category will be:
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).
Introduction category for human health | Exposure Band | Restrictions on hazard characteristics |
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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
Go back to the start of Part 3 Categorisation of chemical introductions
This part discusses:
Exposure Band | Criteria for environment Exposure Bands |
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1 |
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2 |
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3 |
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4 |
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5 |
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6 |
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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:
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.
Examples of treatment | Examples of release without treatment |
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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.
Have your sayAre the criteria for determining the Exposure Bands for environment clear and unambiguous? |
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).
Hazard Band | Criteria for Environment Hazard Characteristics | Classifications under the GHS that will meet the criteria for the Hazard Band |
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E | Any of the following:
| N/A |
D | Any of the following:
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C |
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B | Any of the following:
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A |
| - |
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:
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.
Have your sayAre the criteria for determining the Hazard Bands for environment clear and unambiguous? |
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:
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:
If a chemical introduction is in Exposure Band 3 or 4 for environment, the chemical introduction category will be:
If a chemical introduction is in Exposure Band 5 for environment, the chemical introduction category will be:
If a chemical introduction is in Exposure Band 6 for environment, the chemical introduction category will be:
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.
Introduction category for environment | Exposure Band | Chemical must not have the following hazard characteristics |
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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
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.
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.
Assessment type | Relevant international body |
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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:
| An EU Member State Authority or ECHA, as reviewed by the ECHA Risk Assessment Committee. |
Risk assessments done by applicants for authorisation that:
| 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
| 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.
For use of this pathway, the international risk assessment/evaluation performed by a trusted international prescribed body must:
The risk of introduction into Australia must be no higher than that identified in the overseas jurisdiction. This must take into account:
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
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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:
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
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).
Required information related to chemical identity:
If your chemical is a polymer, in addition to the above, you will also need:
Required information related to exposure characterisation:
Required information related to the hazard characterisation:
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.
Required information related to chemical identity:
If your chemical is a polymer, in addition to the above, you will also need:
Introducers would select from a list such as:
Required information related to exposure characterisation:
Required information related to the hazard characterisation:
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.
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:
|
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:
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. |
Required information related to chemical identity:
If your chemical is a polymer, in addition to the above, you will also need:
Required information related to physico-chemical properties:
Required general introduction information:
Required exposure and release information:
Required hazard and fate information:
Next - Part 5: Categorising an unlisted chemical introduction - hazard information requirements
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The following links take you to the various parts of this section.
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.
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:
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:
|
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:
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:
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
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:
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.
Hazard characteristics | Minimum information requirements (per Exposure Band) | ||||
---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | |
If known (based on specified lists6 and existing information):
| - | 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.
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.
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:
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.
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:
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.
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:
The Minimum information requirements will be:
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.
Additional considerations for polymers with NAMW ≥1,000 Da may result in the polymer introduction being categorised as Exempted. This could involve consideration of:
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.
Minimum information requirements will apply to address the following hazard characteristics:
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.
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:
The minimum information requirements will be:
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.
Additional considerations for polymers with NAMW ≥1,000 Da may result in the polymer introduction being categorised as Exempted. This could involve consideration of:
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.
Minimum information requirements will apply to address the following hazard characteristics:
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.
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.
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
This section outlines what hazard characteristics for the environment need to be addressed (per Exposure Band). Details include the:
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.
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):
| - | 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.
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.
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.
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:
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.
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:
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:
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.
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):
To show that the chemical does not possess these characteristics the following minimum information would be needed:
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.
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:
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:
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.
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):
To show that the chemical does not possess these characteristics the following minimum information would be needed:
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.
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:
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:
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.
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):
To show that the chemical does not possess these characteristics the following additional minimum information would be needed:
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:
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:
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.
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):
To show that the chemical does not possess these characteristics the following additional minimum information would be needed:
Next - 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:
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:
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.
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:
|
|
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. |
|
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:
| 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:
| 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
| These polymers have the potential to be mutagenic. |
|
Halogenated organic chemicals | Halogenated organic chemicals apart from acyl halides. | These chemicals can potentially have the following effects:
| 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 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
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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:
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:
The proposal outlines the:
Further background details are included in section 7.2.
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:
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).
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:
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.
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.
Elements | Size and distribution | Intentionally manufactured | Size dependent properties | Aggregates and agglomerates | Solubility/dissolution rate and persistence at the nanoscale |
---|
The current working definition includes a nanoscale range, defined as:
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:
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 sayWhich size distribution threshold should be used in the categorisation criteria?
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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):
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:
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:
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:
Have your sayWhich option (1, 2 or 3) is appropriate for incorporation into categorisation criteria? |
The current working definition includes:
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 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 sayShould size-dependent properties be included as a criterion for categorisation of unlisted chemicals? |
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:
Have your say
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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
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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:
unless the:
Note that this example incorporates the following elements:
The example does not incorporate the following elements:
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:
Notes to the working definition:
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:
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:
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.
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The following links will take you to various parts of this section:
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:
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:
The introducer would be required to:
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).
The information requirements outlined below are required to:
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.
Example Scenarios | Activities that would meet commercial evaluation authorisation criteria | Activities that would not meet commercial evaluation authorisation criteria |
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Introduction of a chemical for use in coatings |
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Introduction of a chemical for use in inks |
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Introduction of a chemical for use as an additive in fuel |
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Introduction of a chemical for use in mining |
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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.
Have your sayAre the types of activities that would and would not meet the commercial evaluation criteria clear? |
Next - 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:
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.
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 sayWhat 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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The following links take you to various parts of this section.
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:
We assess a chemical. We conclude that the risks it poses are unmanageable. This conclusion will lead to one of the following actions:
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.
Category | Prescribed bodies |
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National risk managers |
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Other national authorities |
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State/territory risk managers |
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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:
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:
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:
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.
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.
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:
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:
Next - 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:
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:
This will be implemented in the delegated legislation by:
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 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:
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.
An introducer intends to introduce a polymer (Polymer 1) that consists of 4 monomers in the following proportions:
Polymer of A, B and C (Polymer 2) is listed on the Inventory.
The proposed introduction volume is 10,000 kg per annum.
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.
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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.
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.
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:
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:
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.
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.
Polymer of low concern, as detailed further in Table 22, means a polymer that either:
A polymer of low concern has the following characteristics:
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:
Note that the level of concern for certain reactive functional groups is shown in Table 24.
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.
In addition, a polymer with NAMW ≥ 10,000 Da must not be capable of absorbing its own weight in water.
Characteristic | Definition |
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Has a low charge density | A polymer has a low charge density if:
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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 atoms | N/A. |
Contains at least 2 atomic elements from the list outlined in the definition column |
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Does not contain (except as impurities) atomic elements other than those from the list outlined in the definition column. |
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Part 1 Di and tri basic acids | ||
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Item | Substance | CAS number |
101 | 1,2‑Benzenedicarboxylic acid | 88‑99‑3 |
102 | 1,3‑Benzenedicarboxylic acid | 121‑91‑5 |
103 | 1,3‑Benzenedicarboxylic acid, dimethyl ester | 1459‑93‑4 |
104 | 1,4‑Benzenedicarboxylic acid | 100‑21‑0 |
105 | 1,4‑Benzenedicarboxylic acid, diethyl ester | 636‑09‑9 |
106 | 1,4‑Benzenedicarboxylic acid, dimethyl ester | 120‑61‑6 |
107 | 1,2,4‑Benzenetricarboxylic acid | 528‑44‑9 |
108 | Butanedioic acid | 110‑15‑6 |
109 | Butanedioic acid, diethyl ester | 123‑25‑1 |
110 | Butanedioic acid, dimethyl ester | 106‑65‑0 |
111 | 2‑Butenedioic acid (E)‑ | 110‑17‑8 |
111A | 1,4‑Cyclohexanedicarboxylic acid | 1076‑97‑7 |
112 | Decanedioic acid | 111‑20‑6 |
113 | Decanedioic acid, diethyl ester | 110‑40‑7 |
114 | Decanedioic acid, dimethyl ester | 106‑79‑6 |
115 | Dodecanedioic acid | 693‑23‑2 |
116 | Fatty acids, C18‑unsaturated, dimers | 61788‑89‑4 |
116A | 2,5‑Furandione, dihydro‑ | 108‑30‑5 |
117 | Heptanedioic acid | 111‑16‑0 |
118 | Heptanedioic acid, dimethyl ester | 1732‑08‑7 |
119 | Hexanedioic acid | 124‑04‑9 |
120 | Hexanedioic acid, dimethyl ester | 627‑93‑0 |
121 | Hexanedioic acid, diethyl ester | 141‑28‑6 |
121A | 5‑Isobenzofurancarboxylic acid, 1,3‑dihydro‑1,3‑dioxo‑ | 552‑30‑7 |
121B | 1,3‑Isobenzofurandione | 85‑44‑9 |
122 | Nonanedioic acid | 123‑99‑9 |
123 | Nonanedioic acid, dimethyl ester | 1732‑10‑1 |
124 | Nonanedioic acid, diethyl ester | 624‑17‑9 |
125 | Octanedioic acid | 505‑48‑6 |
126 | Octanedioic acid, dimethyl ester | 1732‑09‑8 |
127 | Pentanedioic acid | 110‑94‑1 |
128 | Pentanedioic acid, dimethyl ester | 1119‑40‑0 |
129 | Pentanedioic acid, diethyl ester | 818‑38‑2 |
130 | Undecanedioic acid | 1852‑04‑6 |
131 | Unsaturated fatty acids, C18, dimers, hydrogenated | 68783‑41‑5 |
Part 2 Modifiers | ||
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Item | Substance | CAS number |
201 | Acetic acid, 2,2´‑oxybis‑ | 110‑99‑6 |
202 | 1‑Butanol (other than 1‑butanol that is used to manufacture a polyester with maleic or fumaric acid) | 71‑36‑3 |
203 | Cyclohexanol | 108‑93‑0 |
204 | Cyclohexanol, 4,4´‑(1‑methylethylidene)bis | 80‑04‑6 |
204A | Ethanol | 64‑17‑5 |
205 | Ethanol, 2‑(2‑butoxyethoxy)‑ | 112‑34‑5 |
206 | 1‑Hexanol | 111‑27‑3 |
206A | Methanol | 67‑56‑1 |
207 | Methanol, hydrolysis products with trichlorohexylsilane and trichlorophenylsilane | 72318‑84‑4 |
208 | 1‑Phenanthrenemethanol, tetradecahydro‑1,4a‑dimethyl‑7‑(1‑methylethyl)‑ | 13393‑93‑6 |
209 | Phenol, 4,4´‑(1‑methylethylidene)bis‑, polymer with 2,2´‑[(1‑methylethylidene)bis(4,1‑phenyleneoxymethylene)]bis[oxirane] | 25036‑25‑3 |
209A | 1‑Propanol, 2‑methyl‑ | 78‑83‑1 |
210 | Siloxanes and Silicones, dimethyl, diphenyl, polymers with phenyl silsesquioxanes, methoxy‑terminated | 68440‑65‑3 |
211 | Siloxanes and Silicones, dimethyl, methoxy phenyl, polymers with phenyl silsesquioxanes, methoxy‑terminated | 68957‑04‑0 |
212 | Siloxanes and Silicones, methyl phenyl, methoxy phenyl, polymers with phenyl silsesquioxanes, methoxy‑ and phenyl‑terminated | 68957‑06‑2 |
213 | Silsesquioxanes, phenyl propyl | 68037‑90‑1 |
Part 3 Monobasic acids and natural oils | ||
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Item | Substance | CAS number |
301 | Benzoic acid | 65‑85‑0 |
302 | Canola oil | 120962‑03‑0 |
302A | Castor oil | 8001‑79‑4 |
302B | Castor oil, dehydrated | 64147‑40‑6 |
302C | Castor oil, dehydrated, polymerised | 68038‑02‑8 |
303 | Coconut oil | 8001‑31‑8 |
303A | Coconut oil, hydrogenated | 84836‑98‑6 |
304 | Corn oil | 8001‑30‑7 |
304A | Corn‑oil fatty acids | 68308‑50‑9 |
305 | Cottonseed oil | 8001‑29‑4 |
306 | Dodecanoic acid | 143‑07‑7 |
307 | Fats and glyceridic oils, anchovy | 128952‑11‑4 |
308 | Fats and glyceridic oils, babassu | 91078‑92‑1 |
309 | Fats and glyceridic oils, herring | 68153‑06‑0 |
310 | Fats and glyceridic oils, menhaden | 8002‑50‑4 |
311 | Fats and glyceridic oils, sardine | 93334‑41‑9 |
312 | Fats and glyceridic oils, oiticica | 8016‑35‑1 |
312A | Fatty acids, C8‑10 | 68937‑75‑7 |
312B | Fatty acids, C14‑18 and C16‑18‑unsaturated | 67701‑06‑8 |
313 | Fatty acids, C16‑18 and C18‑unsaturated | 67701‑08‑0 |
314 | Fatty acids, castor‑oil | 61789‑44‑4 |
315 | Fatty acids, coco | 61788‑47‑4 |
316 | Fatty acids, dehydrated castor‑oil | 61789‑45‑5 |
317 | Fatty acids, linseed oil | 68424‑45‑3 |
317A | Fatty acids, olive‑oil | 92044‑96‑7 |
318 | Fatty acids, safflower oil | 93165‑34‑5 |
319 | Fatty acids, soya | 68308‑53‑2 |
320 | Fatty acids, sunflower oil | 84625‑38‑7 |
321 | Fatty acids, sunflower‑oil, conjugated | 68953‑27‑5 |
322 | Fatty acids, tall‑oil | 61790‑12‑3 |
323 | Fatty acids, tall‑oil, conjugated | |
324 | Fatty acids, vegetable oil | 61788‑66‑7 |
324A | Fish oil | 8016‑13‑5 |
325 | Glycerides, C16‑18 and C18‑unsaturated | 67701‑30‑8 |
326 | Heptanoic acid | 111‑14‑8 |
326A | Hexadecanoic acid | 57‑10‑3 |
326B | 9‑Hexadecenoic acid, (9Z)‑ | 373‑49‑9 |
327 | Hexanoic acid | 142‑62‑1 |
328 | Hexanoic acid, 3,5,5‑trimethyl | 3302‑10‑1 |
328A | Hexanoic acid, 3,3,5-trimethyl | 23373-12-8 |
329 | Linseed oil | 8001‑26‑1 |
330 | Linseed oil, oxidised | 68649‑95‑6 |
330A | Linseed oil, polymerised | 67746‑08‑1 |
331 | Nonanoic acid | 112‑05‑0 |
331A | Octadecanoic acid | 57‑11‑4 |
331B | 9‑Octadecenoic acid (9Z)‑ | 112‑80‑1 |
331C | 9,12‑Octadecadienoic acid (9Z,12Z)‑ | 60‑33‑3 |
332 | Oils, Cannabis | |
333 | Oils, palm kernel | 8023‑79‑8 |
334 | Oils, perilla | 68132‑21‑8 |
335 | Oils, walnut | 8024‑09‑7 |
335A | Olive oil | 8001‑25‑0 |
336 | Safflower oil | 8001‑23‑8 |
337 | Soybean oil | 8001‑22‑7 |
338 | Sunflower oil | 8001‑21‑6 |
339 | Tung oil | 8001‑20‑5 |
Part 4 Polyols | ||
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Item | Substance | CAS number |
401 | 1,3‑Butanediol | 107‑88‑0 |
402 | 1,4‑Butanediol | 110‑63‑4 |
403 | 1,4‑Cyclohexanedimethanol | 105‑08‑8 |
404 | 1,2‑Ethanediol | 107‑21‑1 |
405 | Ethanol, 2,2´‑oxybis‑ | 111‑46‑6 |
406 | 1,6‑Hexanediol | 629‑11‑8 |
407 | 1,3‑Pentanediol, 2,2,4‑trimethyl‑ | 144‑19‑4 |
408 | 1,2‑Propanediol | 57‑55‑6 |
408A | 1,3‑Propanediol | 504‑63‑2 |
409 | 1,3‑Propanediol, 2,2‑bis(hydroxymethyl)‑ | 115‑77‑5 |
410 | 1,3‑Propanediol, 2,2‑dimethyl‑ | 126‑30‑7 |
411 | 1,3‑Propanediol, 2‑ethyl‑2‑(hydroxymethyl)‑ | 77‑99‑6 |
412 | 1,3‑Propanediol, 2‑(hydroxymethyl)‑2‑methyl | 77‑85‑0 |
413 | 1,3‑Propanediol, 2‑methyl | 2163‑42‑0 |
414 | 1,2,3‑Propanetriol | 56‑81‑5 |
415 | 1,2,3‑Propanetriol, homopolymer | 25618‑55‑7 |
416 | 2‑Propen‑1‑ol, polymer with ethenylbenzene | 25119‑62‑4 |
The following sets out substances that are derivatives of substances set out in parts 1 and 3.
Part 5 Derivatives | |
---|---|
Item | Substance |
1 | A diethyl or triethyl ester of a substance listed in Part 1. |
2 | A dimethyl or trimethyl ester of a substance listed in Part 1. |
3 | A methyl ester of a substance listed in Part 1 or 3. |
4 | An anhydride of a substance listed in Part 1 or 3. |
5 | An ethyl ester of a substance listed in Part 1 or 3. |
Low concern reactive functional groups | |
---|---|
Item | Reactive functional group |
1 | Aliphatic hydroxyls. |
2 | Blocked isocyanates (including ketoxime‑blocked isocyanates). |
3 | Butenedioic acid groups. |
4 | Carboxylic acids. |
5 | Conjugated olefinic groups contained in naturally occurring fats, oils and carboxylic acids. |
6 | Halogens (except reactive halogen‑containing groups such as benzylic or allylic halides). |
6A | Imidazolidinone groups. |
6B | Imides. |
6C | Organic phosphate esters. |
7 | Thiols. |
8 | Unconjugated nitriles. |
9 | Unconjugated olefinic groups considered ’ordinary‘ (that is, unconjugated olefinic groupsnot specifically activated by being part of a larger functional group or by other activating influences). |
Moderate concern reactive functional groups | |
---|---|
Item | Reactive functional group |
1 | Acid anhydrides. |
2 | Acid halides. |
3 | Aldehydes. |
4 | Alkoxysilanes (with alkoxy greater than C2‑alkoxysilane). |
5 | Allyl ethers. |
6 | Conjugated olefinic groups not contained in naturally occurring fats, oils and carboxylic acids. |
7 | Cyanates. |
8 | Epoxides. |
9 | Hemiacetals. |
10 | Imines (ketimines and aldimines). |
11 | Methylol‑amides. |
12 | Methylol‑amines. |
13 | Methylol‑ureas. |
14 | Unsubstituted positions ortho and para to phenolic hydroxyl. |
High concern reactive functional groups | |
---|---|
Item | Reactive functional group |
1 | Alkoxysilanes (with alkoxy of C1‑ or C2‑ alkoxysilane). |
2 | Alpha lactones. |
3 | Aziridines. |
3A | Azo groups. |
4 | Beta lactones. |
5 | Carbodi‑imides. |
5A | Disulfides. |
6 | Halosilanes. |
7 | Hydrazines. |
8 | Hydrosilanes. |
9 | Isocyanates. |
10 | Isothiocyanates. |
11 | Partially‑hydrolysed acrylamides. |
12 | Pendant acrylates. |
13 | Pendant methacrylates. |
13A | Trithiocarbonates. |
14 | Vinyl sulfones or analogous compounds. |
15 | Any 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
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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.
Hazard characteristic | Environmental medium (or compartment or trophic level) | Indicators and numerical thresholds for positive hazard categorisation |
---|---|---|
Persistence | Air | Half-life in air (T½) ≥2 days |
Water | Half-life in water (T½) ≥60 days | |
Soil | Half-life in soil (T½) ≥6 months | |
Sediment | Half-life in sediment (T½) ≥6 months | |
Bioaccumulation | Aquatic | BAF ≥2000 or BCF ≥2000 or log Kow ≥4.2 (if BAF and BCF are not available) |
Terrestrial | log Koa >6 and log Kow ≥2 | |
Food-chain bioaccumulation potential | BMF >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.
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Abbreviation | Full 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 REACH | European 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 product | Genetically modified product |
ICNA Act | The Commonwealth Industrial Chemicals (Notification and Assessment) Act 1989 |
ISO | International Organisation for Standardisation |
Kow | Octanol/water partition coefficient |
LC50 | Median lethal concentration |
IUPAC | International 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 |
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.
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:
|
Categorisation/Categorise/Categorised | Relates to the process and outcome of determining the appropriate chemical introduction category. |
Characterisation Guide | A 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:
|
*Contained import/export | Introduction of a chemical that:
|
Delegated legislation | Legislation 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:
|
*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:
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.
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:
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:
|