Events

Slide 1

Good morning everyone. 
I’m Graeme Barden, Executive Director of the Australian Industrial Chemicals Introduction Scheme (or AICIS), joining you from Gadigal country.
Today we'd like to provide you with an overview of proposed changes to the Rules and Guidelines relating to categorisation, reporting and record keeping requirements for certain introductions.
I would first like to acknowledge the traditional owners and custodians of the lands on which we variously meet today.  For me and the AICIS team here, that is the Gadigal people of the Eora Nation.
We pay our respects to Elders past, present and emerging.
And we extend that acknowledgment to any aboriginal and Torres Strait Islander people joining us today.

Slide 2

To begin, I will explain:

• why we’re proposing changes
• what the consultation process involves, and 
• the next steps

I’ll then hand over to Jacki Kitching and Rebecca Janson, who’ll provide an overview of the changes we’re proposing.

Today is an opportunity for you to hear about the proposed changes, so that: 

• you understand the implications of these changes; and thus
• provide an informed submission to the consultation, should you choose to provide feedback.

At the end of the presentation, we’ll verbally address relevant questions that have been asked via the chat box that is available to you. If you intend to provide any feedback on the proposals themselves, please do so through the forms on our website, not through the chat box during this webinar.

Given the number of changes being proposed, the technical nature of some of these changes and the variety of participants that we have with us today, we won’t go into each of the proposals in detail. Instead, we intend to hold 2 more webinars in October, where we will talk through selected proposals in detail and provide examples. Each webinar would be targeted to different audiences:

• One could primarily focus on proposed changes that are of more relevance to those introducing chemicals for use in cosmetics;
• The other could focus on proposed changes that are of more relevance to those introducing chemicals with other end-uses.

Details on these additional webinars will be provided shortly, although their dates are 17 and 19 October.  

Slide 3

The consultation process for these proposed changes to the Rules and Guidelines is now open, and closes 9 November.

To give some context, this slide demonstrates the hierarchy of legislation and guidance that govern AICIS regulation.

Like all Acts, the Industrial Chemicals Act came into life via the federal parliament and can only be changed by the parliament.  None of the proposals we’re consulting on involve changes to the Industrial Chemicals Act 2019.

The Act authorises the Minister to make the Rules, which establish the technical and operational details of AICIS.  This arrangement allows some flexibility to adapt AICIS in light of scientific and regulatory developments. Your feedback on proposed changes to the Rules will inform the Minister’s considerations.
The Categorisation Guidelines are issued by me as the Executive Director of AICIS. The Guidelines include technical detail to support introducers to categorise their introductions, for example, how to determine hazard characteristics when working out if an introduction can be categorised as exempted or reported. Your feedback on proposed changes to the Guidelines will inform my considerations.

Slide 4

So, why are we proposing changes? The short answer is that we’ve explored possible solutions to address stakeholder advice that certain requirements of the General Rules are challenging to comply with. For example, the difficulties that introducers were having in sourcing information to meet AICIS requirements, where information about a chemical is confidential or commercially sensitive.
At the same time, we have identified aspects of the Rules and Guidelines that we think should be strengthened to ensure protection of human health and the environment or clarify the intent of certain requirements.

Slide 5

The proposals that we're consulting on were developed using an evidence- and risk-based approach to regulation, as appropriate to each circumstance. We’re trying to make requirements more practicable and proportionate to the risk of certain introductions.
I want to be very clear that in each case, the proposals are about changing mechanisms of compliance but not the objective to protect human health and the environment from the introduction and use of industrial chemicals.

Some of the proposals that we’re consulting on include: 

• replacing written undertakings with requirements that would be easier for introducers to comply with 
  • greater acceptance of INCI names for reporting and record keeping 
  • changes to the categorisation criteria to benefit: 
    • soap makers;
    • introducers of chemicals in flavour and fragrance blends; and
    • introducers of hazardous chemicals where the introduction and use of the chemical are controlled; and
• strengthening criteria and/or reporting requirements for health and environmental protection, for example, to prevent persistent organic pollutants (POPs) from being categorised as exempted or reported introductions.

Slide 6

The explanatory information to support this consultation was drafted for viewing online. We have made an offline version available for stakeholder convenience, but you should note that it is essentially just the online content combined into a single document. 

The explanatory information focuses on what is being proposed, why, and suggests impacts.  Full details of the proposed amendments to the Rules are provided in the exposure draft. These are lengthy because a single proposal, if agreed, may cause multiple changes to the Rules, with a single change expressed many times throughout the various places in the Rules where it is relevant.

I’d also like to point out that the provision of an exposure draft is a normal step for government agencies, allowing interested stakeholders to see and provide feedback on the details underpinning the proposal as described in the consultation paper.  An exposure draft can be amended through minor editing through to removal of whole elements if appropriate.  As I said, your feedback will absolutely be considered before the Minster makes any changes to the Rules.

There's no similar exposure draft for proposed changes to the Categorisation Guidelines – the details of these changes are in the explanatory material. We would also publish a notice of and Guideline amendments prior to any changes coming into effect.

To provide feedback - you can comment on all or any of the proposals via our website. There is a single form that allows you to comment on multiple proposals, or there is a form at the bottom of each online proposal to allow to have your say on single proposals. 

All views will be considered once the consultation period has closed on 9 November this year. The detail and type of feedback that we receive will impact on what the next steps are and how long these steps will take, however, if the Minister agrees to amend the Rules, it is expected that amendments would take effect from April 2024. Any amendments to the Guidelines would also take effect at this time. 

In our usual manner, we will publish a summary of feedback we receive and our responses on our website when the final decisions have been taken.

With a reminder that you can ask questions in the chat, I’ll now hand over to Jacki and Rebecca to provide an overview of the proposed amendments.  

Slide 7

Hello everyone, I’m Jacki and I’m going to provide you with an overview of some of the changes that we’re proposing to the Rules to help introducers to meet their obligations.

The items that I'm going to talk to you about are on the left of this slide and are in parts 1 to 5 of Schedule 1 of the exposure draft.

1. Listed introductions: more practicable record-keeping requirements
2. Exempted and reported introductions: more practicable reporting and record-keeping requirements 
3. Soap makers: reducing obligations
4. Flavour/fragrance blend chemicals: expanding the eligibility criteria;

and the first part of item 5, Controlled introduction and use of chemicals: eligibility criteria for low-risk to human health

Rebecca will then take over to provide an overview of changes in the remainder of item 5 and the items on the right of the slide.

As Graeme mentioned, I won’t be going into all of the proposals in detail – this is just to provide you with a sense of the types of changes we’re proposing and their implications.

Firstly, let's talk about listed introductions and our proposals to make the record keeping requirements more practicable. The details of this proposal are in part 1 of Schedule 1 of the exposure draft.

A reminder that a listed introduction is one where the chemical is listed on the AICIS Inventory, and it is being introduced within the terms of the inventory listing.

So before talking about the records that would be needed, I’ll first give a bit of context about record-keeping requirements more generally.

Introducers of industrial chemicals must keep records about their introductions, and these must be held for five years, including for chemicals that are no longer being introduced. 

The information that is needed is prescribed in the Rules and the types of records depend on the introduction category. For example, the information needed for introductions in the exempted category is different than those in the listed category. 

The records help introducers to know that their chemical introductions are authorised; and they must be provided to the Executive Director, if requested. For example, if we ask for the information as part of our compliance monitoring.

Chemicals can be described using various naming conventions and the information conveyed by these naming conventions varies. Currently, for the majority of listed introductions, the CAS name of a chemical is required – where an introducer is unable to get a CAS name for their chemical, they are required to obtain a written undertaking from the person who holds the identity, such as the overseas chemical supplier or chemical manufacturer. The written undertaking must confirm that information can be provided to AICIS, if requested.

There is currently an administrative record keeping arrangement for NICNAS listed introductions in place – I won’t go into the details of this, except to say that this arrangement will expire when amended Rules take effect.

Slide 10

The proposed amendments would make record-keeping obligations simpler and easier for listed introductions where the introducer does not know the chemical's CAS name.
An introducer would have more options of records they can keep. These options are intended to provide flexibility for introducers and also ensure that AICIS has adequate information to accurately identify the Inventory listing for a chemical.

The requirement for an introducer to hold a written undertaking would be replaced with other items, for all listed introductions, regardless of introduction volume.

The existing options in the Rules for listed introductions of 10 kg or less of chemical in a registration year would remain, with only minor consistency amendments proposed.

Slide 11

The proposal is to provide a sequence of 5 options related to chemical identity, with introducers expected to try to fulfil options 1, 2, 3 or 4 (in that order), before resorting to option 5. 

These options would allow for certain names to be held by an introducer (instead of a CAS name) to meet their record keeping obligations for a listed introduction, provided that they also keep records that indicate that the chemical is listed on the Inventory. The names include:

• IUPAC name;
• eligible INCI plant extract name – which are a defined sub-set of INCI names that are considered to provide sufficient chemical identity information; and
• AACN (the AICIS approved chemical name) – which is the approved name that a chemical is introduced under following issuing of an assessment certificate and prior to its listing on the Inventory.
• Each of these names provides adequate information for AICIS to be able to accurately identify the relevant Inventory listing for a chemical and the changes would make it easier for introducers with access to this information to meet their obligations under AICIS.

If it would be reasonably practicable for the introducer to find out the CAS number (if assigned), and the CAS, IUPAC or eligible INCI plant extract name of the chemical, then the introducer is taken to have known it. This ensures that an introducer would actively try to find this information.

Slide 12

If the introducer is unsuccessful in obtaining the information to satisfy options 1-4, then option 5 would apply. The current requirement for them to hold a written undertaking from the person who holds the identity information is proposed to be replaced with requirements that are easier for introducers to comply with, such as:

• the name of a person whom the introducer believes on reasonable grounds, would provide the CAS name and number (if assigned) or IUPAC name, when requested to do so; and
• maintain records of the basis on which the introducer holds this belief. For example, this information could be in an email from the information holder or in minutes of a meeting.

To maintain protections for human health and the environment and ensure that introducers know and hold adequate information about their chemical introductions, this option would also require an introducer to hold a number of other records. We’ll go through these items in more detail in the webinars that will be held in October, but for now, I will say that while the number of records that an introducer would need to hold for this option is more than current, the records should still be easier for an introducer to access and comply with.

Slide 13

The current record keeping requirements relating to any terms of listing for a chemical would remain. We are exploring options to address issues that have been raised by industry regarding their ability to meet their specific information requirement obligations, in cases where the identity of the chemical being introduced is held by the overseas chemical supplier or manufacturer. The options being considered are administrative and/or are related to IT-developments that would assist introducers to meet their obligations. Further engagement on this will occur in 2024. In the meantime, as is currently the case, if an introducer is not confident that they can comply with all terms of listing, they should consider whether their chemical can be introduced in a different introduction category – for example, by following the categorisation process to see if their introduction can be exempted or reported.

Slide 14

Now I’d like to talk about exempted and reported introductions and our proposals to make the reporting and record keeping requirements more practicable. The details of this proposal are in part 2 of Schedule 1 of the exposure draft.

Slide 15

To start off with – I’d like to remind you that exempted introductions are very low risk introductions and reported introductions are low risk. An introducer could work out that their introduction is categorised as exempted or reported at steps 2, 3 and 6 of the categorisation process. I’m not going to go through this process today, for details on that, I suggest that you look at our online Categorisation Guide.

Slide 16

An introducer is required to submit:

• a post-introduction declaration for exempted introductions and
• a pre-introduction report for reported introductions.

Similarly to listed introductions, the introducer is also required to keep records about their exempted and reported introductions. 

This proposal would make reporting and record-keeping obligations simpler and easier for exempted and reported introductions, where the introducer does not know the chemical's CAS name because it is proprietary information of another party.

Slide 17

We’re proposing changes to the reporting and record-keeping requirements, because introducers are experiencing difficulties meeting their obligations when importing chemicals and products from overseas, particularly when the chemical identity information is proprietary. The proposed amendments would provide flexibility for introducers whilst ensuring that AICIS would have access to adequate information for effective compliance monitoring.

As Graeme noted earlier, a single proposal, if agreed, may cause multiple changes to the Rules, with a single change expressed many times throughout the various places in the Rules where it is relevant. This is particularly true for this part of the exposure draft. Our proposals would result in many instances of change to the Rules – they are repetitive and largely relate to these 3 points:

1. Clarifying the type of chemical name that would be accepted in pre-introduction reports, post-introduction declarations and for record keeping purposes – including acceptance of INCI names for certain, lower exposure introductions.
2. Replacing written undertakings with a more practical set of records introducers could keep when they are unable to obtain the chemical identity details. 
3. Reduced, risk-based approach to records that would need to be kept about ‘specified classes of introductions’ when there will be lower exposure to humans and the environment.

These proposals apply across all types of exempted and reported introductions. However, the extent of the proposed changes and requirements differ depending on the type of introduction and/or level of exposure to humans or the environment.

To make these changes, some sections of the current rules would be repealed and restructured, for example, to separate the requirements for introductions that have lower exposure to humans and the environment, versus those with higher exposure.

Slide 18

To clarify the chemical identity reporting and record-keeping requirements, we are proposing to replace the term ‘proper name’ for a chemical in most instances for exempted and reported introductions, with the specific, acceptable name types. This includes either the CAS name or IUPAC name. 

If neither of these names are known to the introducer, a risk-based approach is proposed to be applied whereby INCI names would be accepted, depending on the circumstances of the introduction. This would be an expansion on current requirements, but to be clear, not all INCI names would be accepted in all circumstances. 

• INCI names would be accepted for certain lower exposure introductions
• only ‘eligible INCI plant extract names’ would be accepted for other introductions. 

Further details on this will be provided in the webinar that will be held in October. 

Slide 19

The 2nd type of change to make the requirements for exempted and reported introductions more practicable is to replace written undertakings. 

Written undertakings for exempted and reported introductions could contain different information, depending on the introduction type. For example, an undertaking could be related to:

• chemical identity information 
• properties of the chemical or
• hazard characteristics of the chemical

The proposed requirements that would replace written undertakings would therefore vary depending on the type of introduction and the type of information to which the written undertaking currently applies.

For example, the proposed requirements could include:

• the name of the person or business who the introducer believes on reasonable grounds, would provide certain information to us, if requested PLUS why the introducer believes they would provide this information, and/or
• the basis of the introducers belief that categorisation criteria have been met.

Slide 20

The 3rd type of change relates to a reduced, risk-based approach to records that would need to be kept about ‘specified classes of introductions’ when there will be lower exposure to humans and the environment. 
There is an increased level of concern associated with ‘specified classes of introductions’, because of a greater potential for particular hazards or high levels of human or environmental exposure. There are 14 specified classes of introductions in the Rules, for example UV filters, biochemicals or chemicals with an end use in tattoo inks.

Currently, introducers must know whether their introduction is a specified class of introduction and keep technical information about it, regardless of the circumstances of the introduction. This is proposed to be replaced by a more risk-proportionate approach, whereby for certain lower exposure introductions, information would only need to be held if the chemical was known to the introducer to be a specified class of introduction. 

Slide 21

Now I’d like to talk about our proposals to reduce the regulatory obligation for small-scale soap makers. The details of this proposal are in part 3 of Schedule 1 of the exposure draft. 

This proposal is intended to make it easier and simpler for small-scale soap makers to comply with AICIS registration, categorisation, reporting and record keeping requirements. It is intended to help small or home-based businesses that locally make and sell small amounts of soap, for example at markets. 

The changes that we are proposing are intended to address (or partially address) feedback from small-scale soap makers, that it can be time-intensive and difficult to meet current regulatory requirements under AICIS. The proposed changes achieve a more fit-for-purpose regulation for these types of very low risk introductions. It would make it easier for small-scale soap manufacturers to comply with the requirements and allow AICIS to direct its efforts towards the compliance monitoring of higher risk introductions.

Slide 22

It is important to clarify that these proposals relate to situations where a chemical reaction is occurring to make the soap chemical. We have guidance for soap makers on our website on when a soap maker is required to categorise their introductions. If they are making a soap in Australia using a fat or oil and lye (or aqueous sodium or potassium hydroxide) then these proposals may be relevant to them.

In short, there are 2 proposals, the first where manufacture of the soap chemical would be an exempted introduction and the second where introduction of the chemical would be an excluded introduction. The primary difference between the proposed excluded and exempted criteria relates to the amount of oil the introducer uses to make their soaps in a registration year, i.e. ≤ 10 kg of oil or fat for excluded introductions and ≤ 100 kg of oil or fat for exempted introductions.

Importantly – the soap maker would not need to know the identity (such as CAS number and name) of the soap chemical that they are making. They must know the name of the oil or fat they are using to make the soap – AICIS can then work out the chemical identity of the soap, if needed.   

Slide 23

Practically, these proposed changes would make it easier for small-scale soap makers.

If the introduction is an exempted introduction, the introducer must:

• be registered with AICIS;
• keep records about their introduction; and
• submit an annual declaration.

They would need to keep minimal records about their introduction – i.e. the name of the fat/oil that they used to manufacture the soap and records to show that the criteria are met, such as showing the total volume of fat or oil that they have used in a registration year.

A post-introduction declaration, that is required for other exempted introductions, would not be required for manufactured soaps meeting these proposed criteria.

If all of the soap maker’s introductions are excluded introductions, the introducer would not need to:

• be registered with AICIS;
• categorise their introductions; or
• submit an annual declaration.

If the soap maker imports any ingredients to make their soap or if any of their other introductions are not excluded, they would still need to register with AICIS and meet their obligations for those introductions.
Again, these proposals seek to reduce the regulatory obligation for small-scale soap makers and are not intended to change the regulatory arrangements for commercial soap manufacturers.

Slide 24

The next proposal relates to chemicals introduced in flavour and fragrance blends. The details of this proposal are in part 4 of Schedule 1 of the exposure draft. 

Slide 25

We propose to expand the eligibility criteria so that more introductions of chemicals in flavour and fragrance blends could be categorised as reported introductions at step 3 of the categorisation process. 

Slide 26

The current Rules allow for introductions of chemicals in flavour or fragrance blends that meet specific criteria to be reported (low risk) introductions, with minimal reporting and record keeping requirements. There is no limit on the volume of chemical that may be introduced as part of these criteria, but detailed knowledge about the absence of high-concern hazard characteristics is required, which can only be provided by the person who knows the identity of the chemical.

This proposal is in response to feedback from introducers about issues they have with categorising their introductions and meeting their reporting and record-keeping requirements, due to:

• the chemical identity being proprietary information; and
• the difficulty sourcing information about chemicals in flavour and fragrance blends due to the complex nature of supply chains. 

I won’t go through the criteria in detail today, but put simply, the proposed amendments involve expanding the criteria for chemicals in flavour or fragrance blends to be reported introductions, based on chemicals being on the IFRA Transparency List and being used in accordance with IFRA standards. Additional safeguards are also included to ensure sufficient protection of human health and the environment, including: 

• thresholds on volume and/or concentration of chemicals at introduction and use; and
• criteria that chemicals with known high hazard characteristics would be ineligible (for example, if the chemical is known to meet the GHS criteria for carcinogenicity or the Australian definition for a PBT chemical).

Slide 27

It is worth highlighting that the introduction of any chemical in a flavour or fragrance blend (including chemicals on the Inventory) could be introduced in the reported category, if: 

• the proposed eligibility criteria would be met; and
• the proposed reporting and record-keeping requirements would be met. 

Introducers could submit a single pre-introduction report (PIR) for all chemicals that meet the criteria for ‘low-risk flavour or fragrance blend introductions’. Fit-for-purpose record keeping requirements would also apply.

Slide 28

The final proposal that I will speak with you about relates to eligibility criteria for chemicals that are introduced and used in controlled circumstances to be low risk to human health. The details of this proposal are in part 5 of Schedule 1 of the exposure draft. 

The general concept of there being different regulatory treatment in situations where chemicals are used in controlled circumstances is not new. This concept is already part of our current Rules and it also existed under our former scheme, NICNAS, with controlled use permits.

Slide 29

In this instance, we’re proposing to establish criteria at step 4 of the categorisation process, so that the introductions of hazardous chemicals could be ‘low risk’ for human health, if the introduction and use of the chemicals are strictly controlled. 

This proposal is in response to feedback from introducers that the introductions of hazardous chemicals shouldn’t be in the assessed category, if the chemicals are used in highly controlled settings that would mitigate the risk. Assessed introductions require an application for an assessment certificate to be submitted prior to introduction of the chemical. There is a fee associated with the application and it takes time for AICIS to assess the chemical. 

Slide 30

Risk is a function of both a chemical’s hazards and the level of human or environmental exposure to that chemical. Thus, the premise of this proposal, is that if exposure to the chemical is sufficiently limited, then the risk from introduction of the chemical could be low risk (reported introduction); not very low risk (these would be exempted introductions) and not without risk. The intention is to make the regulatory obligations more proportionate to the risks of these types of introductions.

There are currently criteria in human health exposure band 1 that enable introductions of hazardous chemicals to be low risk to human health. The criteria to limit exposure relate to concentration of the chemical and who can use it. We’re proposing that additional criteria be added to human health exposure band 1, that would effectively mean that more chemicals with characteristics in human health hazard band C, such as carcinogenicity, could be low risk to human health when introduced and used in controlled ways.

Slide 31

The proposed criteria include: 

• limit on the volume of chemical introduced per year;
• the chemical must not have a consumer end use;
• restrictions on who can use the chemical; and
• control measures (such as isolation or engineering controls) that must be in place for those using the chemical. 

Slide 32

An introduction of a chemical that has hazard characteristics in human health hazard band C, such as carcinogenicity, could only be categorised as reported (low risk) if it is also low or very low risk to the environment (step 5 of the categorisation process). Introduction of a chemical that is highly hazardous to the environment, such as those that are persistent, bioaccumulative and toxic (PBT), would still be categorised as assessed.

It is also proposed that the introducer would provide details of the control measures that will be used, in their pre-introduction report that is submitted to AICIS – this way AICIS can prioritise monitoring of introductions, if needed. We are also proposing to update the consumer end use definition to provide further clarity for introducers about when an introduction would have a consumer end use.

Further details on this proposal will be provided at the webinar in October. In the meantime, there are further details, including examples of scenarios that would or wouldn’t meet the criteria in the explanatory information.
I’ll now hand over to Rebecca who will talk through the remainder of the proposals.

Slide 33 

I’ll first be talking to you about some proposals relating to the List of Chemicals with High Hazards for Categorisation, or “the List”. These are proposals for changes to the Guidelines. I won’t go into much detail about these proposals but you can find more information about them in our consultation materials on the website. Also note that these changes are not included in the exposure draft. 

Slide 34

The List of Chemicals with High Hazards for Categorisation is a list of chemicals that are regarded as highly hazardous to human health or the environment by trusted national and international sources. 

Slide 35

Introducers must check this list at steps 4.4 and 5.4 of the categorisation process when working out if their chemical introduction could be categorised as exempted or reported. If a chemical is on the List, it will most likely have to be categorised as assessed.

Slide 36

Our proposals aim to refine the List and streamline the categorisation process for introducers

Four main changes are proposed to the List. 

1. Remove some information sources for the List, including some of the international sources of the list.
2. Remove chemicals from the List that do not meet the definition of an industrial chemical.
3. Add chemicals to the List that have been assessed or evaluated by AICIS and found to have human health hazard band C characteristics or environment hazard band C or D characteristics
4. Refine the current requirement for additional checking of the List if the introduced chemical is a salt or ester

The reasons and details about these proposals are outlined in our consultation material on our website.

Slide 37

The next set of proposals also relate to changes to the Guidelines. Again, I won’t go into much detail about these proposals but you can find more information about them in our consultation materials on the website.

Also note that these changes are not included in the exposure draft. 

Slide 38

We propose to amend some of the options in the Guidelines that introducers can use to demonstrate the absence of certain human health and environment hazard characteristics at steps 4 and 5 of the categorisation process, when working out if their introduction can be categorised as exempted or reported.
The proposed amendments would generally help introducers to categorise their introductions as exempted or reported and meet their record-keeping obligations – for example, more models that can be used for computer predictions of a chemical’s hazard characteristics, i.e. in silico predictions and more OECD test guidelines that can be used to test a chemical’s hazards. We are also proposing to refine some existing requirements.
Please refer to our website consultation material for details.

Slide 39

We’ve finished discussing this first group of proposals now and so we’ll now shift focus and move onto the group of proposals that are intended to strengthen categorisation criteria and reporting to ensure protection of Australians and the environment. 

Slide 40

The first of these relates to fluorinated chemicals. The details of this proposal are in part 7 of Schedule 1 of the exposure draft.

Slide 41

Certain fluorinated chemicals, or their degradation products, may be persistent in the environment, bioaccumulate and be highly toxic. In most circumstances, fluorinated chemicals of high concern are already categorised as assessed. This is the most appropriate outcome, and this proposal will not change this. Rather, the proposal will clarify the fluorinated chemicals of highest concern and align more closely with recent international progress, research and definitions, so they are subject to the appropriate level of regulation. 

Slide 42

This proposal is relevant to steps 4 and 5 of the categorisation process. If you’d like to know more, see our website for more details about this process.

Slide 43

This slide shows the proposed definition. You can also find this in the consultation material on our website. 

Slide 44

Some important aspects to point out are that chemicals meeting the proposed definition of ‘designated fluorinated chemical’:

• could have a linear, branched or cyclic sequence of carbon atoms
• could have a sequence that has multiple breaks
• could be polyfluorinated

Further descriptions and examples of the types of fluorinated chemicals that do and do not fit the proposed definition are provided in the consultation material on our website.

Slide 45

Now another proposal that intends to strengthen protections. This one relates to chemicals with persistent organic pollutant (known as POPs) characteristics. The details of this proposal are in part 6 of Schedule 1 of the exposure draft that you can find on our website.

Slide 46

POPs are chemicals that are of high concern worldwide. This proposal is designed so that chemicals with POPs characteristics are given the same regulatory treatment as those that are formally recognised as POPs under the Stockholm Convention.

We already have strict categorisation rules for POPs that are listed in certain parts of the Stockholm Convention. In most cases, these chemicals cannot be categorised as exempted or reported introductions. We propose to extend this to include chemicals that have POPs characteristics but are yet to be listed in Annex A-C of the Stockholm Convention. This will provide greater protections to Australians and the environment.

Slide 47

This proposal is relevant to step 1 of the categorisation process, which relates to section 25 of the Rules. This means that these high concern chemicals are screened out at the early stages of the categorisation process without needing to interact with the remaining steps of the process.

Slide 48

This slide shows the proposed amendment that would be made to section 25 of the Rules, with the changed text highlighted in yellow. 

In addition to screening out chemicals that are already listed on the Stockholm or Rotterdam conventions at Step 1, we propose to include here chemicals with POPs characteristics that are not yet listed on the Stockholm Convention but have been identified as a persistent organic pollutant by the POPs Review Committee, or meet the screening criteria used by the Review Committee as determined by the Executive Director of AICIS as a result of one of our assessments or evaluations.

You can read more about the exception to the current version of this rule, and the proposed amendment to it, in the consultation material on our website. 

Slide 49

Now another proposal that intends to clarify and strengthen criteria for human health protection. The details of this proposal are in part 8 of Schedule 1 of the exposure draft that you can find on our website. 

Slide 50

This proposal is relevant to step 4 of the categorisation process, where human health risk is considered. See our website for more information about this process.

Slide 51

Chemicals containing certain types of chemical elements are known to be of high concern for human health toxicity. We are proposing to add inorganic arsenic compounds and chemicals containing beryllium, cadmium, chromium (VI), lead or nickel to human health hazard band C, the highest human health hazard band.  
In general, this proposed amendment would not change the categorisation outcome for the chemical introductions to which it would apply, but would make it easier for introducers to work out their applicable introduction category, and decrease the chance of an introducer incorrectly categorising their introduction as exempted or reported. 

Slide 52

This proposal relates to changes to annual declaration requirements. For details, see part 9 of Schedule 1 of the exposure draft of the Rules that you can find on our website. 

Slide 53

The annual declaration is a requirement for all introducers of industrial chemicals. It’s a declaration made about the industrial chemicals that an introducer imported or manufactured during the previous registration year. In it, they need to state the introduction categories that they’ve used and confirm that all their introductions were authorised under our laws. 

We propose to change the annual declaration form so that businesses that imported or manufactured a chemical under the exempted category would need to specify which type of exempted introduction they used. Knowing which types of exempted introductions are being used will provide valuable information for appropriately targeting our compliance activity where it is most needed.

Slide 54

There are currently 8 types of exempted introductions. These are shown on this slide. The proposal regarding small-scale soap manufacturers that we spoke about earlier would add another one, so there would be 9 types of exempted introductions. If the proposed change goes ahead, when an introducer submits their annual declaration in AICIS Business Services and selects ‘exempted introduction’, a checkbox list will appear with these options. The introducer would need to click on each type of exempted introduction relevant to their importation or manufacture for that registration year. 

The proposed change would mean that an introducer’s annual declaration will require slightly more information to be provided, but only if they used the exempted introduction category. Only the types of exempted introduction would be required – not detailed information about the specific chemicals. We expect that most introducers would already know and have records of the information that would be required here. These changes will apply to annual declarations that are made on or after the amended Rules come into force

Slide 55

So we’ve finished talking about the 2 main themes of our proposals. The only remaining theme is the minor proposals that are intended to clarify information and requirements.

Slide 56

These relate to changes that we propose to make to the rules and the guidelines. For  details about these proposals you can refer to parts 10-12 of the exposure draft for the rules related ones, and to our website consultation material for the Guidelines ones. 

Slide 57

These are all quite minor in nature and are not expected to have a significant impact on introducers. These mainly relate to clarifying definitions and criteria. For example, the proposed change for particles in the nanoscale is intended to clarify that when we use the word ‘particles’ in relation to nanoscale particles, that we mean ‘solid particles’.

Slide 58

In summary, we’re proposing to make a number of changes to the Rules and Guidelines to make requirements more practicable and proportionate to the risk of the introductions. 
Many of the proposals are intended to address stakeholder advice that certain requirements are challenging to comply with, and we think the proposed changes will benefit introducers. For example, we’re proposing:

• To replace written undertakings with records that’ll make compliance easier;
• Greater acceptance of INCI names for reporting and record keeping; and
• Changes to the categorisation criteria to benefit:
  • small-scale soap makers
  • introducers of chemicals in flavour and fragrance blends; and
  • introducers of hazardous chemicals where introduction and use are controlled.

We are also proposing some changes to strengthen categorisation criteria and reporting requirements to protect Australians and the environment, and some minor proposals to clarify some specific information and requirements.

Slide 59

So that brings us to the end of today’s webinar. A reminder that the consultation period finishes on the 9th of November, and you can submit your feedback about the consultation through our website up until this date.
Today has been about providing you with an overview of proposed changes to the Rules and Guidelines.

We will be holding two more webinars to give more details about our proposed changes, talk through selected proposals in detail, and provide examples to give them life.

Each webinar would be targeted to different audiences, although everyone is welcome to participate in each.

These webinars will be on the 17th and 19th of October, and we’ll provide all the necessary details on our website.

Thanks very much for joining today’s webinar.

It’s important to us that our communication with you does the job, whether our it’s our specific news items, stakeholder newsletter, regulatory notices, consultation webpages and webinars like this.

So, to finish up, we’d greatly appreciate you taking a few moments to let us know what you thought of today’s webinar. We'll leave the chat function open for anyone who would like to add any comments.Thanks again for joining us today.

I wish you all a great day and close the webinar.

Published date

Slide 1

Good morning, everyone. 

I’m Graeme Barden, Executive Director of the Australian Industrial Chemicals Introduction Scheme (or AICIS), joining you from Gadigal country. And I acknowledge the traditional owners and custodians of the lands on which we variously meet today.

We pay our respects to Elders past, present, and emerging. And we extend that acknowledgment to any aboriginal and Torres Strait Islander people joining us today.
This is the 2nd in our series of three webinars about proposed changes to the Industrial Chemicals General

Rules and the Industrial Chemicals Categorisation Guidelines relating to categorisation, reporting and record keeping requirements for certain introductions. 
The first webinar gave an overview of all of the changes that we are proposing to make. Today's webinar, and the one scheduled for later this week, will detail particular proposals and provide examples. Today we’ll focus on the proposals that are of particular relevance to the introduction of chemicals with end uses other than in cosmetics.

Slide 2

To begin, I'll do a bit of scene-setting for the benefit of any who might not have seen the overview webinar, to remind you of what we’re proposing through this consultation and why, as well as the next steps.
I’ll then pass over to Jacki Kitching and Rebecca Janson, who’ll provide details about the proposals being covered in today's webinar. For each proposal that we detail today, we’ll include examples to give the proposals life so that you can better understand their practical implications.

Throughout the course of the webinar, you can put any questions you have into the chat box, and we’ll verbally address relevant questions at the end of the webinar. A reminder that this is not the place to give feedback on the proposals themselves. There are forms on our website where you can provide your feedback on the proposals.

Slide 3

The final webinar in our series will be held on Thursday this week and will focus on proposals of interest to introducers of chemicals with end use in cosmetics. The webinars will have some overlap in terms of the proposals that will be discussed, because many of the proposals are relevant to all types of introducers and introductions. For the proposals common to the 2 webinars, we’ll provide examples relevant to the target audience of the webinar. You are most welcome, of course, to attend both webinars if you wish. 

Video recordings and transcripts from all webinars in this series will be available on our website shortly after the webinars are complete.  This is already available for the overview webinar. 

Today's webinar will assume some familiarity with AICIS and our processes and current obligations, so it will focus on the proposals themselves.

Slide 4

We are proposing changes to the Rules and the Guidelines. Consultation on these proposals is open until 9 November.

Just a quick reminder about the hierarchy of legislation and guidance that govern AICIS regulation.

The Act sits at the top of the hierarchy and provides the legislative framework of the AICIS scheme. We are not proposing changes to the Act.

The Rules are the next level down. These are made by the Minister and establish the technical and operational details of AICIS. We are proposing changes to the Rules in our current consultation. Your feedback about these proposals will help to inform the Minister's considerations before the amended Rules are finalised.

Those Rules call on the Categorisation Guidelines, which are issued by me as the Executive Director of AICIS. The Guidelines include technical detail to support introducers to categorise their introductions, such as how to determine hazard characteristics when working out if an introduction can be categorised as exempted or reported. Your feedback on proposed changes to the Guidelines will inform my considerations before the amended Guidelines are finalised.

Finally, we have other guidance materials that are found on our website. These aim to help you understand and follow AICIS requirements. After the amended Rules and Guidelines are finalised, our website guidance will be updated to reflect any changes that are made.

Slide 5

So, why are we proposing changes? Stakeholders told us that certain AICIS requirements are challenging to comply with. For example, because Australia is a relatively small market on a global scale, introducers often have difficulty getting the information in the required format to meet AICIS requirements. This is particularly the case where information about a chemical is confidential or commercially sensitive.

Today we’ll take you through proposed changes to assist introducers achieve compliance, for example:

• to replace written undertakings with easier mechanisms,
• to clarify the requirements for obtaining chemical identity information and provide more options,
• to change categorisation criteria where the introduction and use of a chemical are controlled and human exposures are limited,
• and others.

The proposals are designed to change mechanisms of compliance – to help introducers meet their obligations – but not change the objective to protect human health and the environment from the introduction and use of industrial chemicals.

Slide 6

We have also identified aspects of the Rules and Guidelines that we think should be strengthened to ensure the intended protection of human health and the environment. 

We’ll take you through proposals that would prevent fluorinated chemicals of concern, chemicals with persistent organic pollutant (POPs) characteristics, and chemicals containing hazardous elements from being categorised as exempted or reported introductions in most circumstances. 

We are also proposing changes to the annual declaration requirements so that more information is known about the types of exempted introductions, allowing our compliance monitoring to be more targeted and effective.

Slide 7

And we recognised that there were certain requirements that could do with greater clarity. These include clarifying the definition of a biological chemical, clarifying that when the Rules refer to nanoscale 'particles' our interest is in solid particles only, and making some relatively minor Guidelines changes for clarity.
I'll hand over to Jacki in a moment to start providing you with the detail that you joined us today to hear.

Remember that you can ask questions in the chat function of the webinar at any time during the webinar and we’ll come to them at the end. Jacki.

Slide 8

Firstly, I’d like to talk about listed introductions and our proposals to make the record keeping requirements more practicable. A listed introduction is one where the chemical is listed on our Inventory, and the chemical is being introduced in accordance with the terms of the Inventory listing. Stakeholders told us that it can be challenging for them to obtain the records that they need to hold, particularly when the Australian introducer doesn’t know the CAS name of the chemical that they’re introducing. The details of these proposed amendments are in part 1 of Schedule 1 of the exposure draft. Today, I'll explain aspects of the amendments that we think are of more relevance to the audience today. I won’t go into detail about all aspects (for example, record keeping proposals specific to listed introductions of chemicals in flavour and fragrance blends), but if you’re interested in these other aspects, they’ll be covered in our webinar on Thursday.  

Slide 9

Introducers of industrial chemicals must keep records about their introductions, and these must be held for five years, including for chemicals that are no longer being introduced. The records help introducers to know that their chemical introductions are authorised; and they must be provided to the Executive Director, if requested.

For example, if we ask for the information as part of our compliance monitoring.

Currently, there are 2 sets of requirements for listed introductions that are prescribed in the Rules. 

• If 10 kg or less of a chemical will be introduced in a registration year, then the introducer can keep a simpler set of records. 
• Alternatively, the Rules prescribe a set of records to be kept, regardless of the introduction volume of the chemical. 

It is proposed that there would still be 2 sets of requirements for listed introductions. The option for introducers of 10 kg or less of a chemical to keep a simpler set of records would remain, with just a few minor amendments proposed to the requirements to ensure consistency with other amendments that are being proposed. More significant amendments are proposed to be made to the general requirements and the remainder of the slides for this part will be spent talking about some of the proposed changes to these general requirements.

There is currently an administrative record keeping arrangement for certain NICNAS listed introductions that is in place. This arrangement can only be accessed by a subset of introducers who were introducing chemicals that were on the NICNAS Inventory and who continue to introduce those chemicals. It is important to note that this arrangement will no longer be available after the amended Rules take effect.

Slide 10

Currently, the general record-keeping requirements include records related to the identity of the chemical and records to demonstrate that any terms of the listing are met. These records give the introducer confidence that their introduction meets the criteria to be a listed introduction and enable AICIS to confirm that an introduction is authorised as a listed introduction, if the records are requested.

With regards to identity, there are currently options for the records that must be kept, depending on what the introducer knows about the chemical. 

• The first option is that if an introducer knows the CAS number of the chemical, they need to keep a record of this number, as well as the CAS or INCI name. 
• The second option is if the introducer knows the CAS name, then they would keep a record of it. This option applies if the CAS number is not assigned, or not known to the introducer. 
• The final option applies if the introducer doesn’t know the CAS number or CAS name of the chemical.

They’d need to keep a record of the names they use to refer to the chemical, or the names of all products containing the chemical that they import into Australia. They must also hold a written undertaking from the chemical identity holder that they will give AICIS the CAS name and number, if we ask for it. So, if the introducer doesn’t know the CAS name or the CAS number of the chemical, they need to have a written undertaking instead. 

There is also a requirement with all of these options that records are held that demonstrate that any terms of the listing are met. For example, if the terms of the listing includes a defined scope of assessment, the introducer would need to have records that demonstrate that the chemical is being introduced or used in accordance with the defined scope.

Slide 11

Before we go on, a bit more about the current written undertaking requirement. A written undertaking is basically written confirmation from a third-party information holder that certain information will be provided directly to AICIS, if we ask for it. It is only required when the introducer doesn’t know this information themselves. For a listed introduction, it confirms that the person who knows the identity of the chemical (for example, the chemical supplier or manufacturer) will provide the CAS number (if assigned) and CAS name for the chemical, if we ask for it, for example, as part of our compliance monitoring.

It’s not enough for the Australian introducer to just be told that the chemical is on our Inventory. If an introducer doesn’t know the CAS number or CAS name of the chemical that they’re introducing, then they need to contact their supplier to source the written undertaking from the chemical identity holder.
Industry stakeholders have told us that obtaining a written undertaking when the chemical identity is proprietary information can be challenging, particularly when:

• there are multiple steps in the supply chain, or
• the overseas chemical identity holder doesn’t understand the requirements of the Australian market.

So, we’re proposing some changes. The proposed amendments would make record-keeping obligations simpler and easier for listed introductions where the introducer doesn’t know the chemical's CAS name. An introducer would have more options of records they can keep. These options are intended to provide flexibility for introducers and also ensure that AICIS has adequate information to accurately identify the Inventory listing for a chemical.

Slide 12

The proposal is to provide a sequence of 5 options related to chemical identity, with introducers expected to try to fulfil options 1, 2, 3 or 4 (in that order), before resorting to option 5, which I’ll come to. 

This slide shows proposed options 1-4. You'll see that there are more options being proposed, and that these would allow for certain other names to be held by an introducer instead of a CAS name, provided that they also keep records that indicate that the chemical is listed on the Inventory. In comparison to current requirements,

• if an introducer knows the CAS number, option 1 allows more flexibility so that an IUPAC name for the chemical can be held (instead of the current CAS or INCI name only);
• option 2 allows more flexibility, so that if an introducer doesn’t know the CAS number, but they know either the CAS or IUPAC name, then they can keep a record of this plus a record of the information that gave them confidence that the chemical is listed on the Inventory (such as information from their chemical supplier);
• similarly, option 3 allows for certain INCI names to be held. If you’re interested in this option, I suggest you attend our webinar on Thursday or look at our online consultation explanatory materials for further information;
• option 4 allows more flexibility, so that an introducer who previously held an assessment certificate for a chemical that has an AICIS approved chemical name can continue to hold that name once the chemical is listed on our Inventory. 

It is important to note that if it would be reasonably practicable for the introducer to find out the CAS number (if assigned), and the CAS, IUPAC, or eligible INCI plant extract name of the chemical, then the introducer is taken to have known it. This ensures that an introducer would actively try to find this information. If the introducer is unsuccessful in obtaining the information to satisfy options 1-4, then option 5 on the next slide would apply. 

The proposed changes shown in this slide and on the next slide, are really about providing more flexibility and more options for introducers, to make it easier for them to meet their obligations under AICIS. They also ensure that AICIS has adequate information to accurately identify the Inventory listing for a chemical.

Slide 13

Option 5 is shown on this slide. The current requirement for an introducer to hold a written undertaking from the person who holds the identity information is proposed to be replaced with requirements that are easier for introducers to comply with.

While the number of records that an introducer would need to hold for this option is more than current (i.e., more than holding a single written undertaking), the records should be easier for an introducer to access and comply with.

So instead of sourcing a written undertaking from the chemical identity holder, it is proposed that the introducer would need to keep other records, such as:

• the names that they know the chemical by, such as a trade name, and the names of products that they import that contain the chemical,
• a record of the information that gave the introducer confidence that the chemical is listed on the Inventory (such as information from their chemical supplier), and
• the name of the person or business who the introducer reasonably believes would provide the CAS number (if assigned) and the CAS or IUPAC name of the chemical, when requested to do so, plus why the introducer believes this. What we’re seeking is who holds the identity of the chemical and why the introducer thinks that they would give this information to us when requested by them, if we were to audit their introductions. For example, the introducer could hold an email from the identity holder that indicates this, or they could have had a meeting with the identity holder and the introducer has recorded minutes of the meeting indicating that information would be provided on request.

To maintain protections for human health and the environment and ensure that introducers know and hold adequate information about their chemical introductions, this option would also require an introducer to hold a number of other records, including:

1. Information about the volume introduced each year for the chemical or the products containing it. This can be the estimated total volume introduced, such as 1 tonne or less. Remember that records need to be kept for 5 years, including for chemicals that are no longer being introduced. If there is an incident, it is useful for us to be able to know whether only a small amount of chemical is introduced (e.g., 20 kg) or whether a large amount of chemical has been introduced (e.g., 20 tonnes). If you don’t know how much chemical has been introduced, you can keep a record of the volume of product introduced – and remember, the volume can be an estimate.
2. Information about the maximum concentration of the chemical in imported products. We appreciate that the exact concentration of a chemical in a specific product is often proprietary information. Instead of this, we would be seeking the maximum concentration of chemical across types of imported products, for example, if an introducer imports a chemical that is in both paints and inks, then we want to know the maximum concentration in paint and the maximum concentration in ink. We don’t need it broken down into the concentration in each specific colour of paint or ink. The intention is that the introducer would keep general information about what they know about the concentration.
   
   For example:
   
   a. if the SDS for a series of paints containing a chemical indicates that the chemical is present at 30-60% concentration, the maximum would be 60% across all paint products. 
   
   b. if the introducer knows that products contain 50% water, then the introducer knows that the maximum concentration of the chemical in those products is 50%. it is useful for us to know if an imported chemical is present at a high or low concentration in products.
    
3. Finally, any hazard classification for the chemical that the introducer knows. For example, this may be recorded on their SDS.

This option would make it easier for those introducers who know who holds the identity and can show that they will provide information to us on request. If an introducer doesn’t know the identity of a chemical and they don’t know who holds it, then as current, that introducer would not be able to meet their record-keeping obligations.

Slide 14

Regardless of whether option 1-5 applies to an introduction, as current, an introducer would also need to keep records to show that they are complying with any applicable terms of listing for a chemical, i.e.: 

• defined scope of assessment
• conditions relating to introduction or use, or
• specific information requirements.

We are exploring options to address issues that have been raised by industry regarding their ability to meet their specific information requirement obligations, in cases where the identity of the chemical being introduced is held by the overseas chemical supplier or manufacturer. The options being considered are administrative and/or are related to IT-developments that would assist introducers to meet their obligations. Further engagement on this will occur in 2024. In the meantime, as is currently the case, if an introducer is not confident that they can comply with all terms of listing, they should consider whether their chemical can be introduced in a different introduction category – for example, by following the categorisation process to see if their introduction can be exempted or reported.

Slide 15

We’ll now discuss an example of the types of records a person could keep for a listed introduction, if the proposed amendments go ahead.
In this example, a company wants to import a cleaning product, Ultimate cleaner, containing chemicals that are listed on our inventory, but the introducer doesn’t know the CAS name or CAS number of one of the chemicals in the product, as it is proprietary information (Cleaner ingredient #37). 

Currently, the introducer would be required to keep a written undertaking from the chemical identity holder, Cleaning Supplies Co. This means the introducer would need to contact their supplier, and to be able to meet their record keeping obligations, Cleaning Supplies Co. would need to provide the introducer with a written undertaking that they’ll disclose the chemical identity to AICIS, if requested. Cleaning Supplies Co. may or may not be willing to provide this document and if they do, it is likely to require some time to do so. 
Under the proposed amendments, Cleaning Supplies Co. would not need to provide a written undertaking to the introducer. Instead, they can provide an indication that they would provide the CAS number and name to us, if requested. In this case, the introducer had a meeting with Cleaning Supplies Co., and they recorded in the meeting minutes that Cleaning Supplies Co. would provide the CAS number and name to us if requested. They also confirmed that there are no terms of listing that the introducer needs to be aware of. The introducer would need to keep these minutes as their record. They would also keep: 

• The name they know the chemical by, cleaner ingredient #37 
• The name of the finished product they’re importing, Ultimate cleaner 
• The volume of Ultimate cleaner that they import in a registration year, ≤1,000 L
• Now, they don’t have the exact concentration of the chemical in the cleaner. They can see from the SDS that there are 6 other ingredients. They know the typical concentrations of the other ingredients in these types of products, so in this case, they think it is in the range of 20-50% concentration, so they record a maximum concentration of 50%.

· A copy of the product SDS which does not state any hazards, and indicated that all chemicals in the product are listed on the Inventory.

These more practicable requirements would mean that the introducer is able to meet their record-keeping obligations to import Ultimate Cleaner.

Slide 16

So how would these changes affect introducers? Well, we think more introducers who don’t know the CAS names of their chemicals will be able to meet the record-keeping obligations for listed introductions. In particular, the requirement to hold a written undertaking would be replaced by requirements that are more flexible and easier to comply with. 

Introducers that currently hold a written undertaking would need to meet the amended requirements – in practice, the written undertaking would serve as the record for some of the items, but they’d also need to hold:

• information on the volume of chemical or products containing it introduced each year,
• information about the maximum concentration of the chemical in imported products, and
• any hazard classification for the chemical that the introducer knows.

While this is additional items, we are trying to balance adding flexibility in the requirements whilst minimising additional complexity. Also, as demonstrated in previous slides these additional items are quite general and it is expected that introducers would be able to readily meet these requirements.

We are keen to hear from introducers and suppliers. Would this help or are there other options that would make it easier for introducers in situations where they don’t know the chemical's CAS name but that still ensure that AICIS has adequate information to accurately identify the Inventory listing for a chemical.

Slide 17

The remainder of the slides relate to criteria or information required to work out if a chemical can be exempted (very low risk introductions) or reported (low risk introductions) or the obligations (including reporting and record keeping requirements) that apply to these introductions. Some of this information is quite technical. In order for us to get into the detail within the webinar timeframe, we do need to assume a basic level of knowledge about the current categorisation process and the obligations that are associated with exempted and reported introductions. Remember that this webinar is being recorded and it will be made available on our website. So, if you do find that we’re moving too quickly for you, you can always watch it again when we put it on our website, perhaps in conjunction with our categorisation guide or other guidance on our website.
 In this section, I’d like to talk about exempted and reported introductions and our proposal to make the reporting and record keeping requirements more practicable. The details of this proposal are in part 2 of Schedule 1 of the exposure draft. Essentially, this proposal would make reporting and record-keeping obligations simpler and easier, where the introducer does not know the chemical's CAS name because it is proprietary information of another party.

Slide 18

A significant point to note for this part, is that a single proposal, if agreed, could cause multiple changes to the Rules. These proposals would result in many instances of change to the Rules – they are repetitive and largely relate to these 3 points:

1. clarifying the type of chemical name that would be accepted in pre-introduction reports, post-introduction declarations and for record keeping purposes,
2. replacing written undertakings with a more practical set of records introducers could keep when they are unable to obtain the chemical identity details, and
3. a reduced, risk-based approach to records that would need to be kept about ‘specified classes of introductions’ when there will be lower exposure to humans and the environment.

These proposals apply across all types of exempted and reported introductions. However, the extent of the proposed changes and requirements differ depending on the type of introduction and/or level of exposure to humans or the environment. I’ll go through these in more detail in the coming slides, but another point to note is that to make these changes, some sections of the current rules would be repealed and restructured, for example, to separate the requirements for introductions that have lower exposure to humans and the environment, versus those with higher exposure. Ultimately, we think that the changes would make the Rules clearer to introducers.

Slide 19

To clarify the chemical identity reporting and record-keeping requirements, we are proposing to replace the term ‘proper name’ for a chemical in most instances for exempted and reported introductions, with the specific, acceptable name types. This includes either the CAS name or IUPAC name. 

The instances where we are retaining reference to proper name for reporting or record keeping purposes are those related to internationally assessed reported introductions. Internationally assessed introductions are the only reported introduction type where we publish information about the introductions, so it is important to retain the ‘proper name’ term as information holders can apply for the proper name to be protected as confidential business information. The process to protect these names is in our Act. 

If neither the CAS nor IUPAC name is known to the introducer, a risk-based approach is proposed to be applied whereby INCI names would be accepted, depending on the circumstances of the introduction. This would be an expansion on current requirements, but not all INCI names would be accepted in all circumstances. If you’re interested in the circumstances where an INCI name would be accepted, I suggest you attend our webinar on Thursday or look at our online consultation explanatory materials.

Slide 20

The 2nd type of change that we’re proposing, to make the requirements for exempted and reported introductions more practicable, is to replace written undertakings with a more practical set of records introducers could keep when they’re unable to obtain the chemical identity details or other information they need to categorise their introduction or meet their reporting or record-keeping obligations.

The essential elements of a written undertaking are:

• Who knows the information;
• What information do they know; 
• What have they told the introducer to allow them to categorise their introduction; and
• Why does the introducer believe that information will be given to AICIS, on request.

So, in proposing to replace written undertakings with other records, in a general sense, we’re still focusing on these elements, but removing the requirement to hold a written undertaking means greater flexibility for introducers in how they meet their record-keeping obligations.

Slide 21

Unlike listed introductions where written undertakings are all the same and relate to identity of the chemical, written undertakings for exempted and reported introductions could contain very different information, depending on the introduction type and type of information to which the undertaking applies. For example, an undertaking could be related to:

• chemical identity information 
• properties of the chemical or
• hazard characteristics of the chemical.

As the contents of a written undertaking currently varies, the proposed requirements that would replace each undertaking would also vary depending on the type of introduction and the type of information to which the undertaking applies. In each case, what the introducer is required to keep would be stipulated in the Rules and would be expanded on in our online guidance and record-keeping checklists.

For example, for chemical identity, instead of a written undertaking it is proposed that the introducer would keep similar records to what we described for listed introductions, i.e., the name of the person or business who the introducer believes on reasonable grounds, would provide the CAS number (if assigned) and the CAS, IUPAC or eligible INCI plant extract name, if requested PLUS why the introducer believes that they would provide this information.

Similar to listed introductions, what we’re seeking is who holds the identity of the chemical and why the introducer thinks that they would give this information to us when requested by them, if we were to audit their introductions. For example, the introducer could hold an email from the identity holder that indicates this, or they could have had a meeting with the identity holder and the introducer has recorded minutes of the meeting indicating that information would be provided on request.

As I mentioned, we are proposing to replace all references to written undertakings in the Rules with the information that would be required in each case. I won’t go through every case – if you want this level of detail, I suggest that you look at Part 2 of Schedule 1 of the exposure draft, but I will go through a few examples in the coming slides.

Slide 22

Example 2 provides an indication of what is proposed to replace a written undertaking where specific requirements need to be met to be an exempted or reported introduction, i.e., there is an additional record to keep, which is the basis of the introducers belief that the criteria are being met. 
In this example, we’re referring to the polymer of low concern criteria to be an exempted introduction at step 2 of the categorisation process. So, in addition to knowing who would provide the information to us, if requested, and why they believe they’d provide it, the introducer would also need to keep a record of the information that gave them confidence that the chemical is actually a polymer of low concern. For example, the introducer could hold an email from the identity holder that indicates this, or they could have had a meeting with the identity holder and the introducer has recorded minutes of the meeting indicating that the chemical is a polymer of low concern, and that relevant information would be provided to AICIS on request.

Example 3 provides an indication of what is proposed to replace written undertakings to demonstrate the absence of hazard characteristics for higher exposure band introductions. Currently, if the introducer does not have detailed information, including full study reports, of the kind specified in the Industrial Chemicals Categorisation Guidelines, then the introducer needs to hold a written undertaking from the person who holds the detailed information to indicate that the information they hold is of the kind specified in the Guidelines and that this information will be provided to AICIS, if requested. The introducer also needs to hold the outcomes of these studies. It is proposed that the introducer would still need to hold the outcomes, but the written undertaking requirement would be replaced. Instead, in addition to knowing who would provide the information to us, if requested, and why they believe they’d provide it, the introducer would also need to keep a record of why they think the person or business they nominate does hold detailed information, including full study reports, of the kind specified in the Industrial Chemicals Categorisation Guidelines. Essentially, what we’re looking for is who holds the information, why the introducer believes they’ll provide the information to us, if requested, and why the introducer believes that the information that they hold is of the quality that we require to demonstrate the absence of hazard characteristics.

Slide 23

The 3rd type of change that we’re proposing to make so that the requirements are more practicable for exempted and reported introductions relates to a reduced, risk-based approach to records that would need to be kept about ‘specified classes of introductions’ when there will be lower exposure to humans and the environment. This is relevant to chemical introductions categorised as exempted or reported at steps 4-6 of the categorisation process.

There is an increased level of concern associated with ‘specified classes of introductions’, because of a greater potential for particular hazards or high levels of human or environmental exposure. There are 14 specified classes of introductions in the Rules, for example UV filters, biochemicals or chemicals with an end use in tattoo inks.

Currently, introducers must know whether their introduction is a specified class of introduction and keep technical information about it, regardless of the circumstances of the introduction. This is proposed to be replaced by a more risk-proportionate approach, whereby for certain lower exposure introductions, information would only need to be held if the chemical was known to the introducer to be a specified class of introduction.

For exempted introductions, this includes those where the human health exposure band is 1 or 2 and the environment exposure band is 1. For example, introductions of 250 kg or less of a chemical for use in paints.
· For reported introductions, this includes those where the human health exposure band is 1, 2 or 3 and the environment exposure band is 1 or 2. For example, introductions of 1,000 kg or less of a chemical for use in paints (at an introduction or end use concentration greater than 1%).

Note that if it would be reasonably practicable for the introducer to find out that their introduction is one of the 14 specified classes of introduction, then the introducer is taken to have known it. This ensures that an introducer would actively try to find this information. In practice, the introducer could show this by keeping a record to show that they’ve checked this with their chemical supplier.

Slide 24

So how would these changes affect introducers? Well, we think these changes would provide clarity for introducers about the chemical information that is needed for exempted and reported introductions. More introducers who don’t know the CAS or IUPAC names of their chemicals would be able to meet their reporting and record-keeping obligations. In particular, the requirement to hold a written undertaking would be replaced by requirements that are more flexible and easier to comply with. 

Introducers that currently hold a written undertaking would need to meet the amended requirements – however, the written undertaking would serve as the record for those amended items and they wouldn’t need to hold any additional items for those exempted or reported introductions.

As for listed introductions, we are keen to hear from introducers and suppliers about the practicability of these proposed changes compared to current requirements.

Slide 25

The final proposal that I will speak with you about relates to eligibility criteria for chemicals that are introduced and used in controlled circumstances to be low risk to human health. The details of this proposal are in part 5 of Schedule 1 of the exposure draft. 

This proposal is in response to feedback from introducers that the introductions of hazardous chemicals shouldn’t be in the assessed category, if the chemicals are used in highly controlled settings that would mitigate the risk of the introduction.

Slide 26

In this instance, we’re proposing to establish criteria at step 4 of the categorisation process, so that the introductions of hazardous chemicals could be ‘low risk’ for human health, if the introduction and use of the chemicals are strictly controlled. Since risk is a function of both a chemical’s hazards and the level of human or environmental exposure to that chemical, the premise of this proposal, is that if exposure to the chemical is sufficiently limited, then the risk from introduction of the chemical could be low risk (reported introduction); not very low risk (these would be exempted introductions) and not without risk. The intention is to make the regulatory obligations more proportionate to the risks of these types of introductions.

Before we progress to the proposed amended criteria, it is important to note that there are currently criteria in human health exposure band 1 that enable introductions of hazardous chemicals to be low risk to human health – these criteria are shown on the right of this slide. The criteria include:

a) That the introduction of the chemical doesn’t involve a designated kind of human exposure. This effectively means that the chemical can’t be used in tattoo inks or personal vaporisers.

b) That the introduction isn’t for any consumer end use. This is a defined term that I’ll come back to later, but in a general sense, this criterion is to prevent members of the general public from being exposed to the chemical; and

c) That the concentration of the chemical at introduction and at all end uses is less than 0.1%.

So, these existing criteria to limit exposure of humans to the chemical relate to the concentration of the chemical and who can use it. 

We’re proposing that additional criteria be added to human health exposure band 1. I’ll go through these on the next slide, but note that criteria a) and b) from the existing criteria would also apply to the additional criteria. We’re just replacing criterion c) with a set of criteria so that chemicals introduced and used at concentrations of less than 0.1 % could also be low risk, if exposure is strictly controlled.

Slide 27

Proposed criteria c-f are summarised on this slide. 

The human health categorisation volume must be ≤ 25 kg. Now since we’re not talking about consumer products, this effectively means an introduction volume of ≤ 250 kg of chemical per registration year.

During introduction and use of the chemical, control measures to eliminate or minimise exposure of people to the chemical must be implemented. This includes isolating the chemical from people and/or use of engineering controls (including a mechanical device or process). If exposure of people could still occur, that then needs to be minimised, so far as is reasonably practicable, by the implementation of other suitable control measures, which would depend on the circumstances, but include the provision and use of suitable personal protective equipment.

The final criterion is that the industrial chemical is subject to the control of the person who introduces the chemical. This ensures that the person or business that introduces the chemical remains aware of the control measures that are in place and any changes that would impact categorisation.

Slide 28

The proposed additional criteria in human health exposure band 1, would effectively mean that more chemicals with characteristics in human health hazard band C, such as carcinogenicity, could be low risk to human health when introduced and used in controlled ways. In practice, it would mean that some introductions where the human health indicative risk is currently medium to high in exposure band 2 would be shifted to exposure band 1 where the human health indicative risk would be low, and the introduction be in the reported category.
It is important to note that introduction of a chemical that has hazard characteristics in human health hazard band C, could only be categorised as reported (low risk) if it is also low or very low risk to the environment (step 5 of the categorisation process). The introduction of a chemical that is highly hazardous to the environment, such as those that are persistent, bioaccumulative and toxic (PBT), would still be categorised as assessed.

Slide 29

So, let’s look at an example. Our online consultation explanatory material talks through an example where a chemical is used in the manufacture of another chemical. In the example on this slide, a carcinogenic chemical is imported at 5% concentration in paints for use in spray booths. It would only be used by the importer and the controls in place would limit any exposure of humans to the chemical. 200 kg of chemical would be introduced each year and because the chemical is introduced at >0.1% concentration, the current categorisation outcome would be assessed (human health exposure band 2). If the proposed changes go ahead, the human health exposure band would be 1 instead of 2 and the categorisation outcome would be reported. The impact for the introducer is that instead of having to submit a costly application for an assessment certificate, they could submit a free pre-introduction report. There would also be no time-to-market delay due to the assessment process.

Slide 30

Those familiar with the reported introduction pathway, would note that there are 6 pre-introduction report types. The most common or default type that an introducer would use is ‘highest indicative risk is low risk and the other types do not apply’. If this proposal goes ahead, this report type would be amended to account for the additional exposure band criteria and also so that introducers could provide details of the control measures that would be in place during introduction and use of their chemical. Exactly how introducers would provide this information is still to be determined, for example free text, use of picklists or a combination of these, but importantly, based on the information provided in the report, prior to chemical introduction, for these controlled-use introduction types, AICIS would have access to information about:

• the chemical identity,
• known hazards,
• how the chemical would be used, and
• the controls that would be in place.

AICIS could then prioritise monitoring of the introduction, if needed.

If, following introduction of the chemical, the circumstances of the introduction or use would change, the introducer would then need to consider if the introduction remained in this reported introduction type. The introducer may need to vary their pre-introduction report (for example, to update the controls that would be in place), or they may need to re-categorise their introduction.

Slide 31

So how would these changes affect introducers? Well, I hope it’s clear from the preceding slides that these proposed changes could mean that some introductions that would currently be categorised as assessed (medium to high risk) would be able to be categorised as reported (low risk). Introducers would have to meet all reporting and record-keeping requirements for reported introductions – including being able to provide information to AICIS about their introduction if we ask for it.

We are keen to get your feedback on this. For example:

• do you think this would help introducers? or
• are there use scenarios that you’re not sure whether they would fall in or out of the criteria? This sort of feedback is particularly helpful, as if the proposed changes go ahead, it’ll help us avoid ambiguity either through the wording in the Rules itself, or through the online guidance material and examples that would support any Rules amendments.

Slide 32

I mentioned earlier that I would come back to the ‘consumer end use’ defined term. As I said, this term is currently in the Rules for the existing human health exposure band 1 criteria and would also be part of the proposed addition human health exposure band 1 criteria. The criteria not allowing consumer end use is to prevent members of the general public from being exposed to the chemical. We are proposing to add a ‘to avoid doubt’ element to the existing definition, to make it clear that consumer end use includes end use of a chemical in an inhabited residential building (such as a house or unit block) or otherwise, end use of a chemical in areas accessible to the general public (such as shopping centres) before the chemical has been rendered unavailable for human exposure (for example, a chemical in a paint is unavailable for exposure once it has cured).

That brings me to the end of my part of the webinar today. I’m now going to hand over to Bec and she’ll talk through some of the other changes that we’re proposing to make.

Slide 33

We are proposing some refinements relating to the List of Chemicals with High Hazards for Categorisation. These changes would be made in the Guidelines, so they are not detailed in the exposure draft. More information is available on the consultation page of our website. 

Slide 34

The List of Chemicals with High Hazards for Categorisation is a list of chemicals that are recognised nationally and internationally as being highly hazardous to human health or the environment. You can find the List in Appendix 8.1 of the Categorisation Guidelines, available on our website. It’s a collation of chemicals that have been identified by trusted sources as having hazards that are equivalent to the hazard characteristics in human health hazard band C, or environment hazard bands D or C. We've put all the chemicals in one place to make it easier for an introducer to search them. If a chemical is on the List, it is considered by AICIS to have the hazards identified there, without this needing to be verified by separate test results or other information.

Slide 35

At steps 4 and 5 of the categorisation process, an introducer needs to work out the indicative risk of their introduction, first for human health at step 4 and then for the environment at step 5. Then at step 6, the 'highest indicative risk' of the 2 outcomes is considered to get to a final categorisation result. 

Specifically, at steps 4.4 and 5.4 of the categorisation process, an introducer must check the List. If a chemical is on the List, it has one or more of the hazard characteristics in human health hazard band C or environment hazard band D or C, and it will most likely have to be categorised as assessed.

Slide 36

Our proposals aim to refine the List and streamline the categorisation process for introducers to make it simpler to use and quicker to check. We propose that this be done by removing certain entries from the List, adding some entries, and refining the current requirement for additional checking of the List if the introduced chemical is a salt or ester. I'll explain these in the next few slides.

Slide 37

This slide shows the information sources that we are proposing to remove from the information sources for the List. We plan to remove Japan Class II CSCL, noting that Class I would remain. Also schedule 1 of the Canada Toxic Substances List, and substances with an 'equivalent level of concern' from the ECHA REACH Annex XIV Authorisation listing and EU SVHC, and those with 'respiratory sensitising properties' from EU SVHC, as well as Group 3 carcinogens from IARC would be removed. 

Slide 38

Many of the substances on the Class II CSCL are organotin chemicals. These are already captured as being medium to high risk to the environment at step 5.1 of the categorisation process and usually requiring an assessment for introduction volumes greater than 10kg per registration year. So, it is not necessary for the list of chemicals with high hazards for categorisation to be capturing these chemicals later in the process at step 5.4.

It’s appropriate to remove the Canada Toxic Substances List, as this list is risk based, rather than hazard based, and does not clearly align with the relevant hazard characteristics in our highest hazard bands. Given that most of the schedule 1 chemicals would already be captured by other information sources of the list of chemicals with high hazards for categorisation, and so would still end up being in the assessed category.

Slide 39

Currently in appendix 8.1 of the Guidelines, when describing REACH Annex 14 Authorisations and the EU SVHC as sources of the List it says that 'substances with equivalent level of concern" would be on our List. We propose to remove this part of the Guidelines descriptions because substances with equivalent level of concern does not correspond to a specific hazard in human health hazard band C or environment hazard bands D or C. 
There are currently some chemicals that are on the List only because of their listing on the EU SVHC of 'respiratory sensitising properties', or only because of their IARC listing as a group 3 carcinogen by IARC. We propose to remove these respiratory sensitisers from the List because it is not a hazard characteristic in human health hazard band C. We also propose to remove the group 3 carcinogens from the List because the criteria for group 3 does not align with the definitions of carcinogenicity used in the Guidelines. Note that IARC groups 1, 2A and 2B would remain as sources of the List.

If these sources are removed or modified in the ways we propose, relevant chemicals may be removed from the List. However, in most cases, introductions of these chemicals are expected to remain in the assessed category because many of the chemicals on the List are there due to their presence on more than one list source so may not actually be taken off. Or, because the chemicals would be captured as medium to high risk by one of the other categorisation steps. The benefit to introducers is in simplifying the path to this categorisation outcome.

Slide 40

Currently, there are entries on the list of chemicals with high hazards for categorisation that do not meet the definition of an industrial chemical. We propose to remove these entries, as only industrial chemicals are regulated by AICIS. We’ll remove entries that are not chemical elements, those that are not compounds or complexes of chemical elements, and those that are not UVCB substances. For example, currently the List has an entry for occupational exposure as a fire fighter. Entries like this would be removed. We would also remove entries that meet the definition of a radioactive chemical that is given in the Rules. This tidying up of the List would help to avoid potential confusion. 

We also propose that some chemicals would be added to the List at the discretion of the Executive Director of AICIS. These would be chemicals determined by assessment or evaluation by AICIS to have hazard characteristics in Human Health Hazard Band C or Environment Hazard Bands C or D. Confidentiality of chemical identity would be maintained if this has already been granted by AICIS. This proposal would mean that chemicals that have been assessed by AICIS as having the highest hazards would generally not be able to be categorised as exempted or reported at steps 4-6 of the categorisation process.

Slide 41

The final part of this proposal relates to the current additional requirements for chemicals that are esters and salts. Currently, introducers of esters and salts need to check whether their chemical is an ester or salt of every chemical on the List. Rather than requiring introducers to do this for all chemicals, our proposal is that we would specify which chemicals from the List an introducer would need to check if their chemical is an ester or salt of it, and set any applicable boundaries for the chemicals we specify, such as molecular weight cut offs.

This would narrow down the requirement so that it only applies to esters and salts of chemicals expected to be of higher concern. To assist with this, we also propose to add a definition of ester to the Guidelines, i.e., a chemical that can form alcohols and acids by the action of water, dilute acid, or dilute alkali. 

It’s important to note for this last item, that at this stage, we’re consulting on the concept only. The identities of the specific chemicals and applicable boundaries is still being determined. We’ve provided an example in the explanatory consultation material, using the chemical diethanolamine, about how this could work in practice, and this is summarised on this slide. Essentially, it’s intended that by specifying chemicals, we’ll be greatly reducing the number of entries on the List that introducers would need to check to determine if their introduced chemical is an ester or salt and making it easier for introducers to be able to categorise their introductions.
We’ll seek public feedback on the identity of chemicals proposed to be specified, along with any boundaries early 2024, prior to amending the Categorisation Guidelines.

Slide 42

We propose to amend some of the options in the guidelines that introducers can use to demonstrate the absence of certain human health and environment hazard characteristics at steps 4 and 5 of the categorisation process, when working out if their introduction can be categorised as exempted or reported. These proposals are only for the Guidelines so they are not detailed in the exposure draft. More information about them is available on our website. 

The Guidelines provides definitions for most of the hazard characteristics in each hazard band. It also describes the options for information that an introducer can use to demonstrate that a chemical does NOT have these hazard characteristics.

Slide 43

Many of the proposals in this section would help introducers to categorise their introductions as exempted or reported and meet their record-keeping obligations, such as providing more options for demonstrating that a chemical does not have certain hazard characteristics, such as by adding more in silico prediction models that can be used, as well as more test guidelines. We are also proposing to refine or update some of the existing requirements.  

Slide 44

We are proposing to add more in silico models to the Guidelines. The iSafeRat Desktop model and the OASIS CATALOGIC model have been found to give suitable predictions for several end-points.
We propose to include iSafeRat as a model that can be used to demonstrate the absence of: eye damage and eye irritation, acute aquatic toxicity, and bioaccumulation as a function of log Kow. 

And we propose to include OASIS CATALOGIC as a model that can be used for demonstrating the absence of: persistence (as a function of half-life), bioaccumulation (as a function of Log KOW), and acute aquatic toxicity. 

This would give introducers more options to prove that their chemicals do not have certain hazard characteristics.

Slide 45

We propose to add OECD test Guideline 310 as an acceptable test guideline for ready biodegradability in the Guidelines. Currently there is only one other acceptable test guideline for this – OECD test guideline 301. Ready biodegradability test results can be used to demonstrate the absence of a number of environment hazard characteristics in step 5 of the categorisation process, such as the persistence part of the persistent and bioaccumulative hazard characteristic.

We also propose to update the skin sensitisation section of the Guidelines to add an option for proving the absence of this hazard characteristic that is consistent with OECD test guideline 497 – defined approaches for skin sensitisation. This was only published in 2021, so it is appropriate that the guidelines be updated to account for it.

And we are also proposing a small change to the skin irritation section of the Guidelines so that a study showing only GHS category 3 skin reactions would be able to be used to demonstrate the absence of skin irritation. This is an appropriate outcome because category 3 skin reactions are not considered hazardous in Australia.

These extra options should mean that the absence of hazard characteristics should be able to be demonstrated for more introductions.

Slide 46

We are also proposing a change relating to the options in the Guidelines to demonstrate the absence of Specific Target Organ Toxicity after Repeated Exposure for high molecular weight polymers. This hazard characteristic is found in human health hazard band B.

Under this proposal, we would remove the current option where the absence of this hazard can be demonstrated by the polymer not having the skin corrosion hazard characteristic. It would be replaced by an option where the proportion of low molecular weight species in the chemical should be considered. Specifically, an introducer should demonstrate that less than 5% of molecules have a molecular weight lower than 1000 g/mol, and less than 2% of molecules have a molecular weight lower than 500 g/mol. This is an appropriate change because higher levels of low molecular weight species mean that the polymer has greater potential to be of systemic toxicity concern.

It should be noted that this addition would mainly impact on introducers of high molecular weight polymers where the human health exposure band is 4. This proposal would also mean that current introducers of high molecular weight polymers that relied on the skin corrosion option at step 4 of the categorisation process could no longer rely on this information. For such introductions to be categorised as exempted or reported after the amended Guidelines take effect, introducers would instead need to consider other information, such as the level of low molecular weight species. It is only expected to impact a very small number of introducers. We would contact introducers who may be affected by this change, prior to amendments taking effect.

Slide 47

Bioaccumulation potential is a hazard characteristic in environment hazard band A. We propose to remove ready biodegradability test results from the available options for demonstrating the absence of the bioaccumulation potential hazard characteristic. Demonstrating the absence of bioaccumulation potential is only necessary for introductions with an environment exposure band of 3 or 4, where the introducer wants to get to an outcome of very low risk, and thus to be in the exempted introduction category. Note that the results of ready biodegradability tests would still be able to be used for several other environment hazard characteristics in accordance with the Guidelines.

We are proposing this change because the ready biodegradability of a chemical by micro-organisms doesn’t mean that the chemical could not bioaccumulate in other organisms. 

This proposal would mean that future introducers of industrial chemicals would no longer have this option available to them for meeting the bioaccumulation information requirement, and instead would need to use other information to meet the requirements for this end-point. There are a number of other ‘non-study’ options available in the Guidelines, including consideration of molecular weight, levels of low molecular weight species for polymers and the use of in silico predictions. The proposal is only expected to impact a very small number of introducers. We would contact introducers who may be affected by this change, prior to amendments taking effect. 

Slide 48

The next proposal is about fluorinated chemicals. The details of this proposal are in part 7 of Schedule 1 of the exposure draft.​ This is the first of the proposals discussed today that relates to the strengthening of categorisation criteria and reporting requirements to protect Australians and the environment.
​Certain fluorinated chemicals, or their degradation products, may be persistent in the environment, bioaccumulate and be highly toxic. This includes the group of chemicals known as PFAS – per- and poly-fluoroalkyl substances.

Slide 49

At steps 4 and 5 of the categorisation process, an introducer needs to work out the indicative risk of their introduction, first for human health at Step 4 and then for the environment at Step 5. Then at Step 6, the ‘highest indicative risk’ of the 2 outcomes is considered to get to a final categorisation result. 

Slide 50

So, if the indicative risk to human health is medium to high, and the indicative risk to the environment is also medium to high, the outcome will be assessed.

The existing criteria in both steps 4 and 5 captures industrial chemicals that contain a sequence of 4 to 20 fully fluorinated carbon atoms as being medium to high risk for human health and the environment. This means that introductions of such chemicals will be in the assessed category and not in the exempted or reported categories. This is an appropriate outcome, as it means that AICIS will conduct a risk assessment of these chemicals. The first part of our proposal is to replace the term currently in the Rules – 'industrial chemical contains a sequence of greater than or equal to 4, but no more than 20, fully fluorinated carbon atoms' with the term 'designated fluorinated chemical'. All parts of the process that I've just described here will not change. It also means that the final outcome of assessed would remain unchanged for most fluorinated chemicals of highest concern. 

Slide 51

The second part of this proposal is to define the term 'designated fluorinated chemical' in the Rules. This will involve refining the definition that we already have for chemicals containing 4 to 20 fully fluorinated carbon atoms and should clarify and more accurately capture the fluorinated chemicals of highest concern to human health and the environment, aligning more closely with recent international progress, research, and definitions. 

Slide 52

Both the current and the proposed terms and their definitions are shown on this slide. The proposed definition would be added into the “Definitions” in Section 5 of the Rules. We have recognised the need for a clearer definition with less ambiguity, so you may notice that the proposed definition spells out much more explicitly than the current one what structural features would and would not be part of a designated fluorinated chemical.​ I’ll let you take a moment to compare and highlight some key points about the proposed definition on the next slide.

Slide 53

The proposed definition clarifies that the sequence of carbon atoms in a designated fluorinated chemical can be linear, branched, or cyclic, but not part of conjugated double bonds. The sequence could have multiple breaks, as long as those breaks are by a single atom, such as an ether linkage, or by a single substituted atom, such as a carbonyl group. This means that counting the length of the sequence to determine if it has a length of between 4 and 20 does not stop and restart if there are one or more breaks in the sequence. Also, a designated fluorinated chemical could be polyfluorinated, as long as it has at least one CF3 or CF2 group.

Slide 54

The chemical on this slide meets the proposed definition of a designated fluorinated chemical. Parts (a) and (b) of the proposed definition are met – there are 5 fluorinated carbon atoms in the sequence, with the numbering shown in blue. Note that the total length of the sequence is 5 even though it is broken by a non-fluorinated atom. This is allowed because the break consists of only one atom. Part (c) of the definition is also met because the chemical contains a perfluorinated methyl group.​

​Further descriptions and examples of the types of fluorinated chemicals that do and do not fit the proposed definition are provided in the consultation material on our website. 

Slide 55

So, to summarise, the main reasons why we are proposing this change – we considered recent scientific progress in this field and want to ensure that the chemicals captured by our definition are closely aligned with the latest thinking of the types of fluorinated chemicals that are of the highest concern that warrant an AICIS assessment and approval before being introduced into Australia. We also wanted to make the definition clearer so that it is easier for introducers to determine whether their chemical meets the definition or not.​
If the proposed changes to the Rules take effect, anyone who had been introducing a chemical that meets the definition of 'designated fluorinated chemical' – under the exempted category (of the type ‘highest indicative risk is very low’) or reported category (of the type, ‘highest indicative risk is low’) – would have to cease any further introduction of the chemical under those categories.​

If they wished to continue introducing their chemical into Australia, it would be an assessed introduction.​

We plan to contact any affected introducers who had submitted a post-introduction declaration or a pre-introduction report for a designated fluorinated chemical prior to amendments taking effect.

Slide 56

Now moving on to another proposed amendment, which relates to Persistent Organic Pollutants, or POPs. This is another one that aims to strengthen protections. The details of this proposal are in part 6 of Schedule 1 of the exposure draft that you can find on our website.  

Slide 57

At step 1 of the categorisation process, before diving into some of the more detailed considerations to get to the category outcome, an introducer needs to consider whether their introduction can be quickly ruled out of being in the exempted or reported introduction categories. One part of this consideration is whether their chemical is subject to an international agreement or arrangement including those that are listed on the Rotterdam Convention and the Stockholm Convention. Note that the Stockholm Convention is for POPs chemicals. If a chemical is listed on one of these conventions, in most circumstances it will be in the assessed category and an introducer does not need to continue through the remaining steps of the categorisation process. This is an appropriate outcome, as it means that AICIS will conduct a risk assessment of these chemicals of international concern. The proposal we are talking about today will not change this process. 

What we are proposing is to expand the chemicals that would be captured by this part of step 1 of the categorisation process. 

These changes will provide greater protections to Australians and the environment from these chemicals of high concern.

Slide 58

So in addition to screening out chemicals that are already listed on the Stockholm or Rotterdam conventions at Step 1, we propose to also include chemicals with POPs characteristics that are not yet listed on the Stockholm Convention but have been identified as persistent organic pollutants by the POPs Review Committee, or meet the screening criteria used by the Review Committee as determined by the Executive Director of AICIS as a result of one of our assessments or evaluations. Basically, this means that chemicals with POPs characteristics, regardless of whether they have already been formally recognised or not, will have the same regulatory treatment under AICIS. It is designed to appropriately capture more POPs chemicals as assessed introductions instead of exempted or reported introductions and ensure that this happens even if the listing of a chemical on the Stockholm convention takes some time to be finalised. 

If this change goes ahead, we will publish guidance on our website in the categorisation guide to help introducers to understand this requirement. This guidance would include a list of chemicals that have been assessed by us as having POPs characteristics. 

I've mentioned already that introductions of chemicals that have POPs characteristics will, in the majority of circumstances, be in the assessed category, both currently, as well as if the proposed changes are made. There are some exceptions to this outcome. The main one is for chemicals only used for research or analysis that are introduced at 100 kg or less in an AICIS registration year. The category for these introductions would be determined using the AICIS categorisation guide, which you can find on our website.

Slide 59

An example of a chemical that would be captured by this proposed change is DBDPE. AICIS has conducted an assessment that concluded that DBDPE has POPs characteristics. If the proposed change is implemented, introduction of DBDPE could not be in the exempted or reported categories and would need to be assessed.

Slide 60

The details of this next proposal are in part 8 of Schedule 1 of the exposure draft. 

Slide 61

Chemicals containing certain types of chemical elements are known to be of high concern for human health toxicity. 

We are proposing to add to human health hazard band C inorganic arsenic compounds and chemicals containing beryllium, cadmium, chromium (VI), lead or nickel to the highest human health hazard band.   

Slide 62

This proposal is relevant to step 4 of the categorisation process, where human health risk is determined, in particular, where human health hazard characteristics need to be considered, which is called step 4.4 in our website categorisation guide.  

Slide 63

The proposal is to add to Human Health Hazard Band C chemicals that contain any of these hazardous elements. It would be added to the Rules as shown in red on the left of this slide, joining the likes of the highest concern hazards already there, like carcinogenicity, reproductive toxicity, and developmental toxicity. Introductions of chemicals with hazards in human health hazard band C have an indicative Human Health Risk of low if in exposure band 1 or medium-to-high for introductions in exposure bands 2, 3, or 4, as shown on the right-hand side of this slide. So, in most cases introduction of these chemicals will be in the assessed category.
This proposal would not change the categorisation processes at step 4.4. Introductions of any chemical with hazards in human health hazard band C would still have the same indicative risk outcomes of medium to high unless in exposure band 1. 

Also note that introductions of chemicals containing these hazardous elements would already be of medium to high indicative risk to human health under the current Rules because these chemicals have established high toxicity and in most cases are already included on the list of chemicals with high hazards for categorisation. This proposal is not planning to change any of this. Rather, it aims to make it easier for an introducer to get to this outcome. Under this proposal, they would not need to look at the list of chemicals with high hazards for categorisation to work out if their chemical has hazard characteristics that are in human health hazard band C. Instead, they would just need to consider if the chemical contains any of these elements, a much quicker and simpler process for introducers. It should also decrease the chance of an introducer incorrectly categorising their introduction as exempted or reported.

Slide 64

For example, if company ABC wants to introduce nickel oxalate under the current Rules, when they get to step 4.4, to work out the human health hazard characteristics of the chemical they need to start at hazard band C. They read the instructions on our website and realise that they need to check the list of chemicals with high hazards for categorisation to determine whether the chemical has any of the hazard characteristics in hazard band C. They search this list and find that nickel oxalate is on it, and that the list identifies it as having the carcinogenicity hazard characteristic, which is in human health hazard band C. At earlier steps in the categorisation process they already worked out that their introduction is in human health exposure band 3. This means that the indicative human health risk of the introduction is medium to high, and their introduction would be in the assessed category.

Slide 65

Under the proposed rules, if company ABC wants to introduce nickel oxalate, when they get to step 4.4 and start considering hazard band C, they would see that it includes chemicals that contain nickel. They can immediately conclude that the indicative human health risk of the introduction is medium to high, and that the introduction will be in the assessed category, given their established exposure band of 3.

Slide 66

Our next proposed amendment relates to annual declaration requirements. We propose to ask introducers of exempted introductions to specify which types of exempted introductions they have introduced when they complete their Annual Declaration online form at the end of the registration year.  

Slide 67

The annual declaration is a requirement for all introducers of industrial chemicals. It requires an introducer to identify the introduction categories of the chemicals they imported or manufactured during an AICIS registration year. Namely: listed, exempted, reported, assessed, and commercial evaluation. They also need to confirm that all their introductions were authorised under our laws. 

Our proposal applies only to introducers of exempted introductions: when completing an annual declaration, introducers of exempted introductions would be asked to specify which type of exempted introduction they used. Knowing which types of exempted introductions are being used will provide valuable information for appropriately targeting our compliance activity where it is most needed.

Slide 68

If the proposed change goes ahead, when an introducer submits their annual declaration in AICIS Business Services and selects ‘exempted introduction’, a new checkbox list will appear with these options, which are the 8 different types of exempted introductions. The introducer would need to click on each type that is relevant to their importation or manufacture for that registration year. 

The proposed change would mean that an introducer’s annual declaration will require slightly more information to be provided, but only for those that used the exempted introduction category. Only the types of exempted introduction would be required – not detailed information about the specific chemicals. We expect that most introducers would already know and have records of the information that would be required here. These changes will apply to annual declarations that are made on or after the amended Rules come into force.

Exempted introductions are those that are categorised as very low risk to human health and the environment, and they have a corresponding lower level of pre-introduction AICIS requirements because of this. To ensure that exempted introductions are categorised correctly, it is important that we are able to effectively monitor them and check the categorisation criteria have been met. Only the 3 types of exempted introductions that are shown at the top of this slide in orange text require a post introduction declaration to be submitted. A post introduction declaration is a separate requirement to the annual declaration and requires information to be given to AICIS about the introduction of the chemical. This proposed change will allow us to know which types of exempted introductions an introducer uses so we are able to more easily verify whether introducers are complying with their obligation to submit a post-introduction declaration.

Slide 69

To give an example. It has just past the end of the AICIS registration year and Company XYZ wants to do their annual declaration. Under the current Rules, when they go into the AICIS Business Services portal, for their annual declaration they need to select the boxes of the introduction categories that they used during the past registration year. They know they introduced using the listed category and the reported category, and that they had several exempted introductions that they commenced introducing during that year. So, they tick the appropriate boxes and continue on with the remaining parts of their annual declaration to confirm that their introductions were authorised.

Slide 70

Under the proposed rules, the same company would still first select the boxes for listed, reported, and exempted. Because they select exempted, they would be given a set of check boxes with the types of exempted introductions. They know that the types of exempted introductions they used are 'introductions where the highest indicative risk is very low', 'polymers of low concern' and 'introductions for R&D only'. So, they tick these boxes and then go on to the rest of their declaration, which would be the same as it currently is. 

Now I'll hand back over to Graeme.

Slide 71

In summary, we’re proposing a number of changes to the Rules and Guidelines to make requirements more practicable and proportionate to the risk of the introductions. 

Many of the proposals are intended to address stakeholder advice that certain requirements are challenging to comply with. For example, we’re proposing:

• to replace written undertakings with records that will make compliance easier for listed, exempted, and reported introductions; and
• changes to the categorisation criteria to benefit introducers of hazardous chemicals where introduction and use are controlled.

We’re also proposing some changes to strengthen categorisation criteria and reporting requirements to protect Australians and the environment, and some minor proposals to clarify some specific information and requirements that we haven’t detailed today. 

Slide 72

A reminder that you can find information about the proposed amendments to the Rules and Guidelines in the explanatory information on our website. This material is available in both online and offline versions. The content of these two versions is the same, with the offline version just being a collation of the online content into a single document, for convenience.

The explanatory information focusses on what is being proposed, and why, and suggests impacts of the proposed changes.

For the Rules proposals, you can also look at the exposure draft that can be downloaded from our website. This provides full details of the words and sections of the rules that would be changed, allowing stakeholders to see exactly what the changes would entail. 

Note that the exposure draft could be significantly amended after feedback has been received and considered. There's no equivalent to an exposure draft for the proposed changes to the Categorisation Guidelines – the details of these changes are in the explanatory material only. We would also publish a notice of Guideline amendments prior to any changes coming into effect.

To provide feedback - you can comment on any or all the proposals via our website. There is a single form that allows you to comment on multiple proposals, or there is a form at the bottom of each online proposal to allow to have your say on single proposals. 

All views will be considered once the consultation period has closed and before the Minister makes considers changes to the Rules. The detail and type of feedback that we receive will impact on what the next steps are and how long these steps will take, however, if the Minister agrees to amend the Rules, it is expected that amendments would take effect from April 2024. Any amendments to the Guidelines would also take effect at this time. 

Slide 73

So that brings us to the end of the formal part of today’s webinar. A reminder that the consultation period finishes on the 9th of November, and you can submit your feedback about the consultation through our website up until this date.

We’ll be holding another webinar on Thursday which will provide details of proposed changes with a focus on introductions of chemicals with an end use in cosmetics. 

Slide 1

Good morning, everyone. 

I’m Graeme Barden, Executive Director of the Australian Industrial Chemicals Introduction Scheme (or AICIS), joining you from Gadigal country. And I acknowledge the traditional owners and custodians of the lands on which we variously meet today.

We pay our respects to Elders past, present and emerging. And we extend that respect to any aboriginal and Torres Strait Islander people joining us today.

This is the final webinar about proposed changes to the Industrial Chemicals General Rules and the Industrial Chemicals Categorisation Guidelines relating to categorisation, reporting and record keeping requirements for certain introductions. 

The first webinar gave an overview of all of the changes that we are proposing to make. The 2nd webinar that was held on Tuesday this week provided details of proposals that were of particular relevance to the introductions of chemicals with end uses other than in cosmetics. In today's webinar, we’ll provide details of proposals that are of more relevance to the introduction of chemicals with end uses in cosmetics. We can’t provide details of every proposal today – for example, we won’t be talking about proposals to benefit small-scale soap introducers – if you’re interested in this see our first webinar available on our website or our explanatory consultation materials.

If you joined us for the webinar on Tuesday, then you will see that for proposals that are being discussed at both webinars, there is a lot of content overlap. This is because many of the proposals are relevant to both cosmetic and non-cosmetic end uses. We will however reframe the examples that we’re presenting so that they are more relevant to cosmetic end uses.

Slide 2

To begin, I'll do a bit of scene-setting for the benefit of any who might not have seen our earlier webinars, to remind you of what we’re proposing through this consultation and why, as well as the next steps.
I’ll then pass over to Jacki Kitching and Rebecca Janson, who’ll provide details about the proposals being covered in today's webinar. For each proposal that we detail today, we’ll include examples to give the proposals life so that you can better understand their practical implications.

Throughout the course of the webinar, you can put any questions you have into the chat box, and we’ll verbally address relevant questions at the end of the webinar. A reminder that this is not the place to give feedback on the proposals themselves. There are forms on our website where you can provide your feedback on the proposals.

Also, a reminder that video recordings and transcripts from all webinars in this series will be available on our website shortly after the webinars are complete. These are already available for the overview webinar. 
Today's webinar will assume some familiarity with AICIS and our processes and current obligations, so it will focus on the proposals themselves.

Slide 3

We’re proposing changes to the Rules and the Guidelines. Consultation on these proposals is open until 9 November.

Just a quick reminder about the hierarchy of legislation and guidance that govern AICIS regulation.
The Act sits at the top of the hierarchy and provides the legislative framework of the AICIS scheme. We are not proposing changes to the Act.

The Rules are the next level down. These are made by the Minister and establish the technical and operational details of AICIS. We are proposing changes to the Rules in our current consultation. Your feedback about these proposals will help to inform the Minister's considerations before the amended Rules are finalised.

Those Rules call on the Categorisation Guidelines, which are issued by me as the Executive Director of AICIS.

The Guidelines include technical detail to support introducers to categorise their introductions, such as how to determine hazard characteristics when working out if an introduction can be categorised as exempted or reported. Your feedback on proposed changes to the Guidelines will inform my considerations before the amended Guidelines are finalised.

Finally, we have other guidance materials that are found on our website. These aim to help you understand and follow AICIS requirements. After the amended Rules and Guidelines are finalised, our website guidance will be updated to reflect any changes that are made.

Slide 4

So, why are we proposing changes? Stakeholders told us that certain AICIS requirements are challenging to comply with. For example, because Australia is a relatively small market on a global scale, introducers often have difficulty getting the information in the required format to meet AICIS requirements. This is particularly the case where information about a chemical is confidential or commercially sensitive.

Today, we’ll take you through proposed changes to assist introducers achieve compliance, for example:

• to replace written undertakings with easier mechanisms
• to clarify the requirements for obtaining chemical identity information and provide more options, such as greater acceptance of INCI names
• to change categorisation criteria to benefit introducers of chemicals in flavour and fragrance blends
• and others

The proposals are designed to change mechanisms of compliance – to help introducers meet their obligations – but not change the objective to protect human health and the environment from the introduction and use of industrial chemicals.  And not to completely remove AICIS’ ability to know the specific chemical identity of chemicals introduced into Australia.

Slide 5

We have also identified aspects of the Rules and Guidelines that we think should be strengthened to ensure the intended protection of human health and the environment. These include proposals that would prevent fluorinated chemicals of concern, chemicals with persistent organic pollutant (POPs) characteristics, and chemicals containing hazardous elements from being categorised as exempted or reported introductions in most circumstances. These proposals were discussed at our webinar on Tuesday and we won’t be going through them today, but if you’re interested you can view the recorded webinar when it becomes available or look at our explanatory consultation materials. 

We are also proposing changes to the annual declaration requirements so that more information is known about the types of exempted introductions, allowing our compliance monitoring to be more targeted and effective. We’ll talk more about this later in the webinar.

Slide 6

And we recognised that there were certain requirements that could do with greater clarity. These include clarifying the definition of a biological chemical, clarifying that when the Rules refer to nanoscale 'particles' our interest is in solid particles only, and making some relatively minor Guidelines changes for clarity.

I'll hand over to Jacki in a moment to start providing you with the detail that you joined us today to hear.

Remember that you can ask questions in the chat function of the webinar at any time during the webinar and we’ll come to them at the end. Note that these questions are sent directly to AICIS and are not visible by other attendees. Jacki.

Slide 7

Firstly, I’d like to talk about listed introductions and our proposals to make the record keeping requirements more practicable. A listed introduction is one where the chemical is listed on our Inventory, and the chemical is being introduced in accordance with the terms of the Inventory listing. Stakeholders told us that it can be challenging for them to obtain the records that they need to hold, particularly when the Australian introducer doesn’t know the CAS name of the chemical that they’re introducing. The details of these proposed amendments are in part 1 of Schedule 1 of the exposure draft. 

Slide 8

Introducers of industrial chemicals must keep records about their introductions, and these must be held for five years, including for chemicals that are no longer being introduced. The records help introducers to know that their chemical introductions are authorised; and they must be provided to the Executive Director, if requested.

For example, if we ask for the information as part of our compliance monitoring.

Currently, there are 2 sets of requirements for listed introductions that are prescribed in the Rules. 

• If 10 kg or less of a chemical will be introduced in a registration year, then the introducer can keep a simpler set of records. 
• Alternatively, the Rules prescribe a set of records to be kept, regardless of the introduction volume of the chemical. 

It is proposed that there would still be 2 sets of requirements for listed introductions. The option for introducers of 10 kg or less of a chemical to keep a simpler set of records would remain, with minor amendments proposed to the requirements to ensure consistency with other amendments that are being proposed. I’ll talk more about these later on. More significant amendments are proposed to be made to the general requirements and the bulk of the slides for this part will be spent talking about the proposed changes to these general requirements.
 There is currently an administrative record keeping arrangement for certain NICNAS listed introductions that is in place. This arrangement can only be accessed by a subset of introducers who were introducing chemicals that were on the NICNAS Inventory and who continue to introduce those chemicals. It is important to note that this arrangement will no longer be available after the amended Rules take effect.

Slide 9

Currently, the general record-keeping requirements include records related to the identity of the chemical and records to demonstrate that any terms of the listing are met. These records give the introducer confidence that their introduction meets the criteria to be a listed introduction and enable AICIS to confirm that an introduction is authorised as a listed introduction, if the records are requested.

With regards to identity, there are currently options for the records that must be kept, depending on what the introducer knows about the chemical. 

• The first option is that if an introducer knows the CAS number of the chemical, they need to keep a record of this number, as well as the CAS or INCI name. 
• The second option is if the introducer knows the CAS name, then they would keep a record of it. This option applies if the CAS number is not assigned, or not known to the introducer. 
• The final option applies if the introducer doesn’t know the CAS number or CAS name of the chemical. They’d need to keep a record of the names they use to refer to the chemical, or the names of all products containing the chemical that they import into Australia. They must also hold a written undertaking from the chemical identity holder that they will give AICIS the CAS name and number, if we ask for it. So, if the introducer doesn’t know the CAS name or the CAS number of the chemical, they need to have a written undertaking instead. 

There is also a requirement with all of these options that records are held that demonstrate that any terms of the listing are met. For example, if the terms of the listing includes a defined scope of assessment, the introducer would need to have records that demonstrate that the chemical is being introduced or used in accordance with the defined scope.

Slide 10

Before we go on, a bit more about the current written undertaking requirement. A written undertaking is basically written confirmation from a third-party information holder that certain information will be provided directly to AICIS, if we ask for it. It is only required when the introducer doesn’t know this information themselves. For a listed introduction, it confirms that the person who knows the identity of the chemical (for example, the chemical supplier or manufacturer) will provide the CAS number (if assigned) and CAS name for the chemical, if we ask for it, for example, as part of our compliance monitoring.

It’s not enough for the Australian introducer to just be told that the chemical is on our Inventory. If an introducer doesn’t know the CAS number or CAS name of the chemical that they’re introducing, then they need to contact their supplier to source the written undertaking from the chemical identity holder.

Industry stakeholders have told us that obtaining a written undertaking when the chemical identity is proprietary information can be challenging, particularly when:

• there are multiple steps in the supply chain, or
• the overseas chemical identity holder doesn’t understand the requirements of the Australian market.

So we’re proposing some changes. The proposed amendments would make record-keeping obligations simpler and easier for listed introductions where the introducer doesn’t know the chemical's CAS name. An introducer would have more options of records they can keep. These options are intended to provide flexibility for introducers and also ensure that AICIS has adequate information to accurately identify the Inventory listing for a chemical.

Slide 11

The proposal is to provide a sequence of 5 options related to chemical identity, with introducers expected to try to fulfil options 1, 2, 3 or 4 (in that order), before resorting to option 5, which I’ll come to. 

This slide shows proposed options 1 and 2. In comparison to current requirements,

• If an introducer knows the CAS number, option 1 allows more flexibility so that an IUPAC name for the chemical can be held (instead of the current CAS or INCI name only)
• Option 2 allows more flexibility, so that if an introducer doesn’t know the CAS number, but they know either the CAS or IUPAC name, then they can keep a record of this plus a record of the information that gave them confidence that the chemical is listed on the Inventory (such as information from their chemical supplier).

Slide 12

This slide shows proposed option 3. It allows for eligible INCI plant extract names to be held. The proposed definition of an eligible INCI plant extract name that would be included in the Rules is shown on this slide. These are a defined sub-set of INCI names that are considered to provide sufficient chemical identity information. 

• The chemical must be a plant extract that has not intentionally undergone any chemical processes, or treatments, to change its chemical structure. For example, the chemical cannot be hydrolysed, acetylated or hydrogenated (for example, hydrogenated sweet almond oil would not be eligible).
• The INCI name must be based on a botanical name for the relevant plant, so for example Helianthus annuus Leaf/Stem Extract is based on a botanical name whereas sunflower extract is not.  

Slide 13

It is important to note that if it would be reasonably practicable for the introducer to find out the CAS number (if assigned), and the CAS, IUPAC or eligible INCI plant extract name of the chemical, then the introducer is taken to have known it. This ensures that an introducer would actively try to find this information. 
Moving on to option 4 – it allows more flexibility, so that an introducer who previously held an assessment certificate for a chemical that has an AICIS approved chemical name can continue to hold that name once the chemical is listed on our Inventory. So as you can see, there are more options being proposed, and these would allow for certain other names to be held by an introducer instead of a CAS name, provided that the introducer also keep records that indicate that the chemical is listed on the Inventory.

If the introducer is unsuccessful in obtaining the information to satisfy options 1-4, then option 5 on the next slide would apply. 

The proposed changes shown in these slides are really about providing more flexibility and more options for introducers, to make it easier for them to meet their obligations under AICIS. They also ensure that AICIS has adequate information to accurately identify the Inventory listing for a chemical.

Slide 14

Option 5 is shown on this slide. The current requirement for an introducer to hold a written undertaking from the person who holds the identity information is proposed to be replaced with requirements that are easier for introducers to comply with.

While the number of records that an introducer would need to hold for this option is more than current (i.e. more than holding a single written undertaking), the records should be easier for an introducer to access and comply with. 

So instead of sourcing a written undertaking from the chemical identity holder, it is proposed that the introducer would need to keep other records, such as:

• The names of products that they import that contain the chemical.
• Either: 
  • the names that they know the chemical by, such as a trade name, or
  • both the name of the flavour or fragrance blend that the chemical is to be introduced as part of and records that show the chemical is included on the IFRA Transparency List. This could be provided by the chemical supplier. 
• A record of the information that gave the introducer confidence that the chemical is listed on the Inventory (such as information from their chemical supplier).
• The name of the person or business who the introducer reasonably believes would provide the CAS number (if assigned) and the CAS or IUPAC name of the chemical, when requested to do so, plus why the introducer believes this. What we’re seeking is who holds the identity of the chemical and why the introducer thinks that they would give this information to us when requested by them, if we were to audit their introductions. For example, the introducer could hold an email from the identity holder that indicates this, or they could have had a meeting with the identity holder and the introducer has recorded minutes of the meeting indicating that information would be provided on request.

To maintain protections for human health and the environment and ensure that introducers know and hold adequate information about their chemical introductions, this option would also require an introducer to hold a number of other records, including:

1. Information about the volume introduced each year for the chemical or the products containing it. This can be the estimated total volume introduced, such as 1 tonne or less. Remember that records need to be kept for 5 years, including for chemicals that are no longer being introduced. If there is an incident, it is useful for us to be able to know whether only a small amount of chemical is introduced (e.g. 20 kg) or whether a large amount of chemical has been introduced (e.g. 20 tonnes). If you don’t know how much chemical has been introduced, you can keep a record of the volume of product introduced – and remember, the volume can be an estimate.
2. Information about the maximum concentration of the chemical in imported products. We appreciate that the exact concentration of a chemical in a specific product is often proprietary information. Instead of this, we would be seeking the maximum concentration of chemical across types of imported products, for example, if an introducer imports a chemical that is in both lipsticks and body lotions, then we want to know the maximum concentration in lipstick and the maximum concentration in body lotion. We don’t need it broken down into the concentration in each specific shade of lipstick or type of body lotion. The intention is that the introducer would keep general information about what they know about the concentration.
   
   For example:
   
   - if the technical documentation for a suite of body lotions indicates that the chemical is present at 20-40% concentration, the maximum would be 40% across the body lotions. 
   - if the introducer has no idea what the specific concentration is, but knows that products contain 50% water, then the introducer knows that the maximum concentration of the chemical in those products is 50%. It is useful for us to know if an imported chemical is present at a high or low concentration in products.
3. Finally, any hazard classification for the chemical that the introducer knows. For example, this may be recorded on their SDS. The intention here is that if the introducer knows that a chemical they are importing has a hazard classification, then they keep a record of it.

This option would make it easier for those introducers who know who holds the identity, and can show that they will provide information to us on request. If an introducer doesn’t know the identity of a chemical and they don’t know who holds it, then as current, that introducer would not be able to meet their record-keeping obligations.

Slide 15

Regardless of whether option 1-5 applies to an introduction, as current, an introducer would also need to keep records to show that they are complying with any applicable terms of listing for a chemical, i.e.: 

• defined scope of assessment
• conditions relating to introduction or use, or
• specific information requirements.

We are exploring options to address issues that have been raised by industry regarding their ability to meet their specific information requirement obligations, in cases where the identity of the chemical being introduced is held by the overseas chemical supplier or manufacturer. The options being considered are administrative and/or are related to IT-developments that would assist introducers to meet their obligations. Further engagement on this will occur in 2024. In the meantime, as is currently the case, if an introducer is not confident that they can comply with all terms of listing, they should consider whether their chemical can be introduced in a different introduction category – for example, by following the categorisation process to see if their introduction can be exempted or reported.

Slide 16

We’ll now discuss an example of the types of records a person could keep for a listed introduction, if the proposed amendments go ahead.

In this example, a company wants to import a moisturiser, Amazing skin lotion, containing chemicals that are listed on our inventory, but the introducer doesn’t know the CAS name or CAS number of 2 of the chemicals in the product. They work out that they have an eligible INCI plant extract name for one of these ingredients, so under amended Rules, they would be able to keep a record of this name plus the information that gave them confidence that the extract is listed on our Inventory.

For the other ingredient, currently, the introducer would be required to keep a written undertaking from the chemical identity holder, Cosmetic Supplies Co. This means the introducer would need to contact their supplier, and to be able to meet their record keeping obligations, Cosmetic Supplies Co. would need to provide the introducer with a written undertaking that they’ll disclose the chemical identity to AICIS, if requested. Cosmetic Supplies Co. may or may not be willing to provide this document and if they do, it is likely to require some time to do so. 

Under the proposed amendments, Cosmetics Supplies Co. would not need to provide a written undertaking to the introducer. Instead, they can provide an indication that they would provide the CAS number and name to us, if requested. In this case, the introducer had a meeting with Cosmetic Supplies Co. and they recorded in the meeting minutes that Cosmetic Supplies Co. would provide the CAS number and name to us if requested. They also confirmed that there are no terms of listing that the introducer needs to be aware of. The introducer would need to keep these minutes as their record. They would also keep: 

• The name they know the chemical by, moisturiser ingredient #101 
• The name of the finished product they’re importing, Amazing skin lotion 
• The volume of Amazing skin lotion that they import in a registration year, ≤1,000 L
• Now, they don’t know the concentration of the chemical in the lotion. They can see from the SDS that there are many other ingredients. They know that the lotion contains 60% water, so they record a maximum concentration of 40% chemical.
• A copy of the product SDS which does not state any hazards, and indicated that all chemicals in the product are listed on the Inventory.

These more practicable requirements would mean that the introducer is able to meet their record-keeping obligations to import Amazing skin lotion.

Slide 17

So I’ve talked about the changes that we’re proposing to make to the general record-keeping requirements for listed introductions. Now I’ll briefly talk about the changes that we’re proposing for requirements for introductions of 10 kg or less of chemical in a registration year. As I mentioned earlier, only a minor amendment is proposed, that is, to provide a new option for introductions of chemicals in flavour and fragrance blends that are on the IFRA Transparency List, so that the introducer could keep a record of the name of the blend, rather than the name that they know the chemical by. This change is largely to ensure consistency with other amendments that are being proposed.

Slide 18

So how would these changes affect introducers? Well, we think more introducers who don’t know the CAS names of their chemicals will be able to meet the record-keeping obligations for listed introductions. In particular, the requirement to hold a written undertaking would be replaced by requirements that are more flexible and easier to comply with. 

Introducers that currently hold a written undertaking would need to meet the amended requirements – in practice, the written undertaking would serve as the record for some of the items, but they’d also need to hold:

• information on the volume of chemical or products containing it introduced each year
• information about the maximum concentration of the chemical in imported products 
• any hazard classification for the chemical that the introducer knows.

While these are additional items, we are trying to balance adding flexibility in the requirements and minimising additional complexity. Also, as demonstrated in previous slides, these proposed items are quite general and it is expected that introducers would be able to readily meet these requirements.

We are keen to hear from introducers and suppliers. Would this help or are there other options that would make it easier for introducers in situations where they don’t know the chemical's CAS name but that still ensure that AICIS has adequate information to accurately identify the Inventory listing for a chemical.

Slide 19

The remainder of the slides relate to criteria or information required to work out if a chemical can be exempted (very low risk introductions) or reported (low risk introductions) or the obligations (including reporting and record keeping requirements) that apply to these introductions. Some of this information is quite technical. In order for us to get into the detail within the webinar timeframe, we do need to assume a basic level of knowledge about the current categorisation process and the obligations that are associated with exempted and reported introductions. Remember that this webinar is being recorded and it will be made available on our website. So if you do find that we’re moving too quickly for you, you can always watch it again when we put it on our website, perhaps in conjunction with our categorisation guide or other guidance on our website.
 
In this section, I’d like to talk about exempted and reported introductions and our proposal to make the reporting and record keeping requirements more practicable. The details of this proposal are in part 2 of Schedule 1 of the exposure draft. Essentially, this proposal would make reporting and record-keeping obligations simpler and easier, where the introducer does not know the chemical's CAS name because it is proprietary information of another party.

Slide 20

A significant point to note for this part, is that a single proposal, if agreed, could cause multiple changes to the Rules. These proposals would result in many instances of change to the Rules – they are repetitive and largely relate to these 3 points:

1. Clarifying the type of chemical name that would be accepted in pre-introduction reports, post-introduction declarations and for record keeping purposes
2. Replacing written undertakings with a more practical set of records introducers could keep when they are unable to obtain the chemical identity details, and
3. A reduced, risk-based approach to records that would need to be kept about ‘specified classes of introductions’ when there will be lower exposure to humans and the environment.

These proposals apply across all types of exempted and reported introductions. However, the extent of the proposed changes and requirements differ depending on the type of introduction and/or level of exposure to humans or the environment. I’ll go through these in more detail in the coming slides, but another point to note is that to make these changes, some sections of the current rules would be repealed and restructured, for example, to separate the requirements for introductions that have lower exposure to humans and the environment, versus those with higher exposure. Ultimately, we think that the changes would make the Rules clearer to introducers.

Slide 21

To clarify the chemical identity reporting and record-keeping requirements, we are proposing to replace the term ‘proper name’ for a chemical in most instances for exempted and reported introductions, with the specific, acceptable name types. This includes either the CAS name or IUPAC name. 

The instances where we are retaining reference to proper name for reporting or record keeping purposes are those related to internationally assessed reported introductions. Internationally assessed introductions are the only reported introduction type where we publish information about the introductions, so it is important to retain the ‘proper name’ term as information holders can apply for the proper name to be protected as confidential business information. The process to protect these names is in our Act. 

If neither the CAS or IUPAC name is known to the introducer, a risk-based approach is proposed to be applied whereby INCI names would be accepted, depending on the circumstances of the introduction. This would be an expansion on current requirements, but not all INCI names would be accepted in all circumstances. 

Slide 22

So INCI names would be accepted for certain lower exposure introductions and only ‘eligible INCI plant extract names’ would be accepted for other introductions.

The level of detail that INCI names convey about a chemical is often not as precise as other naming conventions, such as CAS names and IUPAC names. For example, INCI names are used to convey information about ingredients on cosmetic product labels – a simpler chemical name may be suitable for this purpose, but the name may not contain the level of information about the chemical’s identity necessary for regulatory certainty. Therefore, a risk-based approach is proposed, where INCI names would only be accepted for certain lower exposure introductions.

For introductions that are categorised as exempted at steps 4-6 of the categorisation process, INCI names would be accepted in circumstances where the human health exposure band is 1 or 2 and the environment exposure band is 1. For example, introductions of 25 kg or less of a chemical for use in cosmetics.
For introductions that are categorised as reported at steps 4-6 of the categorisation process, INCI names would be accepted in circumstances where the human health exposure band is 1, 2 or 3 and the environment exposure band is 1 or 2. For example, introductions of 100 kg or less of a chemical for use in cosmetics (or 1000 kg if the concentration of the chemical at introduction and at all end uses is 1% or less).

Slide 23

So how would this benefit introducers? To demonstrate this, I’m going to use the example of a pre-introduction report that needs to be submitted for reported introductions.

In this case, the introducer knows the INCI name for the chemical, but not the CAS number or CAS or IUPAC name. The chemical is also not a plant extract. 

A maximum of 100 kg of chemical will be imported in formulated cosmetic products per registration year. The introducer works out that the introduction is categorised as reported.

• It’s in human health exposure band 3 and environment exposure band 2 and 
• The chemical has none of the hazard characteristics in the highest human health and environment hazard bands.

Under the current requirements, the introducer would need the AICIS business services ID of the chemical identity holder. The CAS number (if assigned) and CAS or IUPAC name of the chemical would then need to be entered into the pre-introduction report by the chemical identity holder, before the introducer could submit their report and introduce the products containing the chemical. 
If the proposed changes go ahead, the introducer could just submit the pre-introduction report with the INCI name – they wouldn’t need the AICIS business services ID for the chemical identity holder and there would be no time delay in submitting their report. 

Slide 24

The 2nd type of change that we’re proposing, to make the requirements for exempted and reported introductions more practicable, is to replace written undertakings with a more practical set of records introducers could keep when they’re unable to obtain the chemical identity details or other information they need to categorise their introduction or meet their reporting or record-keeping obligations.

The essential elements of a written undertaking are:

• Who knows the information;
• What information do they know; 
• What have they told the introducer to allow them to categorise their introduction; and
• Why does the introducer believe that information will be given to AICIS, on request.

So in proposing to replace written undertakings with other records, in a general sense, we’re still focusing on these elements, but removing the requirement to hold a written undertaking means greater flexibility for introducers in how they meet their record-keeping obligations.

It’s important to remember though, that if the changes that we’re proposing related to greater acceptance of INCI names go ahead, then there would be less introductions of chemicals with an end use in cosmetics that written undertakings would apply to anyway.

Slide 25

Unlike listed introductions where written undertakings are all the same and relate to identity of the chemical, written undertakings for exempted and reported introductions could contain very different information, depending on the introduction type and type of information to which the undertaking applies. For example, an undertaking could be related to:

• chemical identity information 
• properties of the chemical or
• hazard characteristics of the chemical.

As the contents of a written undertaking currently varies, the proposed requirements that would replace each undertaking would also vary depending on the type of introduction and the type of information to which the undertaking applies. In each case, what the introducer is required to keep would be stipulated in the Rules and would be expanded on in our online guidance and record-keeping checklists.
 
For example, for chemical identity, instead of a written undertaking it is proposed that the introducer would keep similar records to what we described for listed introductions, i.e., the name of the person or business who the introducer believes on reasonable grounds, would provide the CAS number (if assigned) and the CAS, IUPAC or eligible INCI plant extract name, if requested PLUS why the introducer believes that they would provide this information.

Similar to listed introductions, what we’re seeking is who holds the identity of the chemical and why the introducer thinks that they would give this information to us when requested by them, if we were to audit their introductions. For example, the introducer could hold an email from the identity holder that indicates this, or they could have had a meeting with the identity holder and the introducer has recorded minutes of the meeting indicating that information would be provided on request.

As I mentioned, we are proposing to replace all references to written undertakings in the Rules with the information that would be required in each case. I won’t go through every case – if you want this level of detail, I suggest that you look at Part 2 of Schedule 1 of the exposure draft, but I will go through a few examples in the coming slides.

Slide 26

Example 2 provides an indication of what is proposed to replace a written undertaking where specific requirements need to be met to be an exempted or reported introduction, i.e. there is an additional record to keep, which is the basis of the introducers belief that the criteria are being met. 

In this example, we’re referring to the polymer of low concern criteria to be an exempted introduction at step 2 of the categorisation process. So, in addition to knowing who would provide the information to us, if requested, and why they believe they’d provide it, the introducer would also need to keep a record of the information that gave them confidence that the chemical is actually a polymer of low concern. For example, the introducer could hold an email from the identity holder that indicates this, or they could have had a meeting with the identity holder and the introducer has recorded minutes of the meeting indicating that the chemical is a polymer of low concern and that relevant information would be provided to AICIS on request.

Example 3 provides an indication of what is proposed to replace written undertakings to demonstrate the absence of hazard characteristics for higher exposure band introductions. Currently, if the introducer does not have detailed information, including full study reports, of the kind specified in the Industrial Chemicals Categorisation Guidelines, then the introducer needs to hold a written undertaking from the person who holds the detailed information to indicate that the information they hold is of the kind specified in the Guidelines and that this information will be provided to AICIS, if requested. The introducer also needs to hold the outcomes of these studies. It is proposed that the introducer would still need to hold the outcomes, but the written undertaking requirement would be replaced. Instead, in addition to knowing who would provide the information to us, if requested, and why they believe they’d provide it, the introducer would also need to keep a record of why they think the person or business they nominate does hold detailed information, including full study reports, of the kind specified in the Industrial Chemicals Categorisation Guidelines. Essentially, what we’re looking for is who holds the information, why the introducer believes they’ll provide the information to us, if requested, and why the introducer believes that the information that they hold is of the quality that we require to demonstrate the absence of hazard characteristics.

Slide 27

The 3rd type of change that we’re proposing to make so that the requirements are more practicable for exempted and reported introductions relates to a reduced, risk-based approach to records that would need to be kept about ‘specified classes of introductions’ when there will be lower exposure to humans and the environment. This is relevant to chemical introductions categorised as exempted or reported at steps 4-6 of the categorisation process.

There is an increased level of concern associated with ‘specified classes of introductions’, because of a greater potential for particular hazards or high levels of human or environmental exposure. There are 14 specified classes of introductions in the Rules, for example UV filters, biochemicals or chemicals with an end use in tattoo inks.

Currently, introducers must know whether their introduction is a specified class of introduction and keep technical information about it, regardless of the circumstances of the introduction. This is proposed to be replaced by a more risk-proportionate approach, whereby for certain lower exposure introductions, information would only need to be held if the chemical was known to the introducer to be a specified class of introduction.

Similar to the lower exposure introductions that were previously described:

• For introductions that are categorised as exempted at steps 4-6 of the categorisation process, this includes circumstances where the human health exposure band is 1 or 2 and the environment exposure band is 1. For example, introductions of 25 kg or less of a chemical for use in cosmetics.
• For introductions that are categorised as reported at steps 4-6 of the categorisation process, this includes circumstances where the human health exposure band is 1, 2 or 3 and the environment exposure band is 1 or 2. For example, introductions of 100 kg or less of a chemical for use in cosmetics (or 1000 kg if the concentration of the chemical at introduction and at all end uses is 1% or less).

Note that if it would be reasonably practicable for the introducer to find out that their introduction is one of the 14 specified classes of introduction, then the introducer is taken to have known it. This ensures that an introducer would actively try to find this information. In practice, the introducer could show this by keeping a record to show that they’ve checked this with their chemical supplier.

Slide 28

So how would these changes affect introducers? Well, we think these changes would provide clarity for introducers about the chemical information that is needed for exempted and reported introductions. More introducers who don’t know the CAS or IUPAC names of their chemicals would be able to meet their reporting and record-keeping obligations. In particular, the requirement to hold a written undertaking would be replaced by requirements that are more flexible and easier to comply with. 

Introducers that currently hold a written undertaking would need to meet the amended requirements – however, the written undertaking would serve as the record for those amended items and they wouldn’t need to hold any additional items for those exempted or reported introductions.

As for listed introductions, we are keen to hear from introducers and suppliers about the practicability of these proposed changes compared to current requirements.

Slide 29

The next proposal relates to chemicals introduced in flavour and fragrance blends. The details of this proposal are in part 4 of Schedule 1 of the exposure draft. 

Slide 30

Before going into details about this proposal, I’d like to briefly talk about current requirements. The current categorisation criteria allow certain introductions of chemicals in flavour or fragrance blends to be categorised as reported (low risk) introductions at step 3 of the categorisation process. Some key points to note are that:

• this excludes any chemical that is ineligible for the reported category at step 1 – for example, chemicals subject to international agreements or arrangements, including the Rotterdam or Stockholm Conventions.
• specific low-risk flavour or fragrance blend introduction criteria apply at step 3 and these must be met. I’ll talk more about these criteria on the next slide.
• the introduction of any chemical in a flavour or fragrance blend (including chemicals on the Inventory) could be categorised as reported if the criteria are met, as well as the reporting and record-keeping requirements; and
• the reporting and record-keeping requirements are specific to low-risk flavour or fragrance blend introductions – for example, the current Rules specify that a single pre-introduction report could be submitted for all chemicals in the blend that meet the criteria.

It is also worth noting that we have several defined terms in the Rules around flavour and fragrance blend introductions. Importantly, these clarify that chemicals may be introduced as part of the blend itself, or in combination with other chemicals, such as in formulated cosmetic products. 

Slide 31

So we propose to expand the eligibility criteria so that more introductions of chemicals in flavour and fragrance blends that are on the IFRA Transparency List and used in accordance with IFRA standards, could be categorised as reported introductions at step 3 of the categorisation process.

The current Rules criteria are summarised on the left of this slide. There is no limit on the volume of chemical that may be introduced as part of these criteria, but there are limits associated with concentration and detailed knowledge about the absence of high-concern hazard characteristics is required, which can only be provided by the person who knows the identity of the chemical.

Our proposal to expand the criteria, is in response to feedback from introducers about issues they have with categorising their introductions and meeting their reporting and record-keeping requirements, due to:

• the chemical identity being proprietary information; and
• the difficulty sourcing information about chemicals in flavour and fragrance blends due to the complex nature of supply chains. 

As the introducer may not be as confident about the hazard characteristics of chemicals they are introducing, the proposed criteria include volume and/or concentration limitations. That is, either:

• the volume of chemical introduced in a registration year would be ≤1,000 kg and the maximum concentration of the chemical at introduction and at all end uses is 1%, or
• the volume of chemical introduced in a registration year would be 10 kg or less (with no concentration limit).

As a safeguard, the chemical could not be known by the introducer to be:

• carcinogen, mutagen or toxic to reproduction (CMR)
• persistent, bioaccumulative and toxic (PBT) or
• cause adverse effects mediated by an endocrine mode of action.

We know that there would be some chemicals in flavour or fragrance blends that would not meet these criteria. However, we are proposing to expand the criteria, whilst ensuring sufficient protections for human health and the environment.

Slide 32

So let’s look at an example. In this case, Company A will import up to 300 kg per year of a face cream containing up to 1% of a fragrance blend. The identities of the chemicals in the blend and the concentrations of those chemicals is proprietary information, but Company A knows who holds this information and that the CAS numbers and CAS names of the chemicals in the blend will be given to AICIS, if requested.

Based on the information from their supplier, they know that all chemicals in the blend are on the Inventory, except 1 and that all chemicals in the blend are on the IFRA Transparency List and use will be in accordance with IFRA standards. Their supplier has also indicated that there are no chemicals in the blend that are excluded from being reported at step 1 of the categorisation process and none known to be CMR, PBT or cause adverse effects by an endocrine mode of action.

Under the current criteria, this would not be sufficient for the introducer to categorise their introduction as a low-risk flavour or fragrance blend introduction at step 3 of the categorisation process. The introducer would need to have more information to demonstrate the absence of the highest concern human health and environment hazard characteristics, and in fact, currently they would need this confidence through holding of a written undertaking.

Slide 33

This introduction would meet the proposed new criteria to be a reported, low-risk flavour or fragrance blend introduction at step 3 of the categorisation process. Note that even though they don’t know the exact concentration of chemical, based on knowing the maximum concentration of the blend, they can confidently meet both concentration and/or volume criteria (but they only need to meet 1 of them).
Company A can categorise the introductions of all chemicals in the blend as reported and submit a single pre-introduction report for the blend that covers all chemicals.

Slide 34

Moving on to the pre-introduction report now. The single report for all chemicals in a blend that meet the criteria for ‘low-risk flavour or fragrance blend introductions’ would be regardless of whether the existing or new criteria are met.

We are proposing some changes to the report requirements. These would apply to any report submitted or varied on or after the amendments take effect. Any reports submitted prior to that date would still be valid.

So, introducers would still need to provide the name of the blend. The clarification changes around chemical identity that we discussed for exempted and reported introductions earlier would apply, i.e. replacing proper name with specific names, including CAS, IUPAC and eligible INCI plant extract name. Consistent with the proposed replacement of written undertaking requirements that we discussed earlier, in their pre-introduction report, the introducer would provide details of who holds the identity of the chemical and why the introducer thinks that they would give this information to us when requested by them, if we were to audit their introductions. For example, the introducer could hold an email from the identity holder that indicates this, or they could have had a meeting with the identity holder and the introducer has recorded minutes of the meeting indicating that information would be provided on request. 

The other current report requirements, shown in the yellow box, are proposed to be replaced with more meaningful requirements that would assist AICIS monitoring of introductions and that are consistent with information provided for other types of reported introductions. In this case, it is proposed that the introducer would provide an indication of whether the current or amended criteria apply and a declaration that the criteria are being met. 

Slide 35

With regards to record-keeping requirements, as previously mentioned, the current written undertaking requirement is proposed to be replaced with more practicable requirements, similar to other exempted and reported introductions.

All other records are similar to those that are currently required to be kept for low-risk flavour or fragrance blend introductions. These are based around information that an introducer should know or should have access to. 
Introducers that currently hold a written undertaking would need to meet the amended requirements – however, the written undertaking would serve as the record for those amended items and they wouldn’t need to hold any additional items for those exempted or reported introductions.

Slide 36

So how would these changes affect introducers? Well, we think these changes would mean that introductions of more chemicals that are on the IFRA Transparency List and used in accordance with IFRA standards could be categorised as reported at step 3 of the categorisation process. Introducers would also be able to meet their reporting and record keeping obligations more easily.

As for other introductions, we are keen to hear from introducers and suppliers about the practicability of these proposed changes compared to current requirements.

I’ll now hand over to Bec to talk through some of the other proposals.

Slide 37

We are proposing some refinements relating to the List of Chemicals with High Hazards for Categorisation. These changes would be made in the Guidelines so they are not detailed in the exposure draft. More information is available on the consultation page of our website. 

Slide 38

The List of Chemicals with High Hazards for Categorisation is a list of chemicals that are recognised nationally and internationally as being highly hazardous to human health or the environment. You can find the List in Appendix 8.1 of the Categorisation Guidelines, available on our website. It's a collation of chemicals that have been identified by trusted sources as having hazards that are equivalent to the hazard characteristics in human health hazard band C, or environment hazard bands D and C. We've put all the chemicals in one place to make it easier for an introducer to search them. If a chemical is on the List, it is considered by AICIS to have the hazards identified there, without this needing to be verified by separate test results or other information.

Slide 39

At steps 4 and 5 of the categorisation process, an introducer needs to work out the indicative risk of their introduction, first for human health at step 4 and then for the environment at step 5. Then at step 6, the 'highest indicative risk' of the 2 outcomes is considered to get to a final categorisation result. 
Specifically, its at steps 4.4 and 5.4 of the categorisation process that an introducer must check the List. If a chemical is on the List, it has one or more of the hazard characteristics in human health hazard band C or environment hazard band D or C, and it will most likely have to be categorised as assessed.

Slide 40

Our proposals aim to refine the List and streamline the categorisation process for introducers to make it simpler to use and quicker to check. We propose that this be done by removing certain entries from the List, adding some entries, and refining the current requirement for additional checking of the List if the introduced chemical is a salt or ester. I'll explain these in the next few slides.

Slide 41

This slide shows the information sources that we are proposing to remove from the information sources for the List. We plan to remove Japan Class II CSCL, noting that Class I would remain. Also schedule 1 of the Canada Toxic Substances list, and substances with an 'equivalent level of concern' from the ECHA REACH Annex XIV Authorisation listing and EU SVHC, and those with 'respiratory sensitising properties' from EU SVHC, as well as Group 3 carcinogens from IARC would be removed. 

Slide 42

Many of the substances on the Class II CSCL are organotin chemicals. These are already captured as being medium to high risk to the environment at step 5.1 of the categorisation process and usually requiring an assessment for introduction volumes greater than 10kg per registration year. So its not necessary for the list of chemicals with high hazards for categorisation to be capturing these chemicals later in the process at step 5.4.
Its appropriate to remove the Canada Toxic Substances List, as it is risk based, rather than hazard based, and does not clearly align with the relevant hazard characteristics in our highest hazard bands. Also, most of the schedule 1 chemicals would already be captured by other information sources of the list of chemicals with high hazards for categorisation, and so would still end up being in the assessed category.

Slide 43

Currently in appendix 8.1 of the Guidelines, when describing REACH Annex 14 Authorisations and the EU SVHC as sources of the List it says that 'substances with equivalent level of concern’ would be on our List. We propose to remove this part of the Guidelines descriptions because ‘substances with equivalent level of concern’ does not correspond to a specific hazard in human health hazard band C or environment hazard bands D or C. 

There are currently some chemicals that are on the List only because of their listing on the EU SVHC of 'respiratory sensitising properties', or only because of their listing as a group 3 carcinogen by IARC. We propose to remove these respiratory sensitisers from the List because it is not a hazard characteristic in human health hazard band C. We also propose to remove the group 3 carcinogens from the List because the criteria for group 3 does not align with the definitions of carcinogenicity used in the Guidelines. Note that IARC groups 1, 2A and 2B would remain as sources of the List.

If these sources are removed or modified in the ways we propose, relevant chemicals may be removed from the List. However, in most cases, introductions of these chemicals are expected to remain in the assessed category because many of the chemicals on the List are there due to their presence on more than one list source so may not actually be taken off. Also, many of these chemicals would be captured as medium to high risk by one of the other categorisation steps anyway. The benefit to introducers is in simplifying the path to this categorisation outcome.

Slide 44

Currently, there are entries on the list of chemicals with high hazards for categorisation that do not meet the definition of an industrial chemical. We propose to remove these entries, as only industrial chemicals are regulated by AICIS. We’ll remove entries that are not chemical elements, those that are not compounds or complexes of chemical elements, and those that are not UVCB substances. For example, currently the List has an entry for occupational exposure as a fire fighter. Entries like this would be removed. We would also remove entries that meet the definition of a radioactive chemical that is given in the Rules. This tidying up of the List would help to avoid potential confusion. 

We also propose that some chemicals would be added to the List at the discretion of the Executive Director of AICIS. These would be chemicals determined by assessment or evaluation by AICIS to have hazard characteristics in Human Health Hazard Band C or Environment Hazard Bands C or D. Confidentiality of chemical identity would be maintained if this has already been granted by AICIS. This proposal would mean that chemicals that have been assessed by AICIS as having the highest hazards would generally not be able to be categorised as exempted or reported at steps 4-6 of the categorisation process.

Slide 45

The final part of this proposal relates to the current requirements for chemicals that are esters and salts. Currently, introducers of esters and salts need to check whether their chemical is an ester or salt of every chemical on the List. Rather than requiring introducers to do this for all chemicals, we propose to specify which chemicals from the List an introducer would need to check if their chemical is an ester or salt of it, and set any applicable boundaries for the chemicals we specify, such as molecular weight cut offs. This would narrow down the requirement so that it only applies to esters and salts of chemicals expected to be of higher concern. To assist with this, we also propose to add a definition of ester to the Guidelines, which would be -  a chemical that can form alcohols and acids by the action of water, dilute acid or dilute alkali. 

It’s important to note for this last item that, at this stage, we’re consulting on the concept only. The identities of the specific chemicals and applicable boundaries is still being determined. We’ve provided an example in the explanatory consultation material, using the chemical diethanolamine, about how this could work in practice and its summarised on this slide. Essentially, it’s intended that by specifying chemicals, we’ll be greatly reducing the number of entries on the List that introducers would need to check to determine if their introduced chemical is an ester or salt, and making it easier for introducers to be able to categorise their introductions.

We’ll seek public feedback on the identity of chemicals proposed to be specified, along with any boundaries early 2024, prior to amending the Categorisation Guidelines.

Slide 46

We propose to amend some of the options in the guidelines that introducers can use to demonstrate the absence of certain human health and environment hazard characteristics at steps 4 and 5 of the categorisation process, when working out if their introduction can be categorised as exempted or reported. These proposals are only for the Guidelines so they are not detailed in the exposure draft. More information is available on our website. 

The Guidelines provides definitions for most of the hazard characteristics in each hazard band. It also describes the options for information that an introducer can use to demonstrate that a chemical does NOT have these hazard characteristics.

Slide 47

Many of the proposals in this section would help introducers to categorise their introductions as exempted or reported, such as providing more options for demonstrating that a chemical does not have certain hazard characteristics, for example, by adding more in silico prediction models that can be used, as well as more test guidelines. We are also proposing to refine or update some of the existing requirements.  

Slide 48

We are proposing to add more in silico models to the Guidelines. The iSafeRat Desktop model and the OASIS CATALOGIC model have been found to give suitable predictions for several end-points.

We propose to include iSafeRat as a model that can be used to demonstrate the absence of: eye damage and eye irritation, acute aquatic toxicity and bioaccumulation as a function of log Kow. 

And we propose to include OASIS CATALOGIC as a model that can be used for demonstrating the absence of: persistence (as a function of half-life), bioaccumulation (as a function of Log KOW), and acute aquatic toxicity. 

This would give introducers more options to prove that their chemicals do not have certain hazard characteristics.

Slide 49

We propose to add OECD test Guideline 310 as an acceptable test guideline for ready biodegradability in the Guidelines. Currently there is only one other acceptable test guideline for this – OECD test guideline 301. Ready biodegradability test results can be used to demonstrate the absence of a number of environment hazard characteristics in step 5 of the categorisation process, such as the persistence part of the persistent and bioaccumulative hazard characteristic.

We also propose to update the skin sensitisation section of the Guidelines to add an option for proving the absence of this hazard characteristic that is consistent with OECD test guideline 497 – defined approaches for skin sensitisation. This was only published in 2021, so it is appropriate that the guidelines be updated to account for it.

And we are also proposing a small change to the skin irritation section of the Guidelines so that a study showing only GHS category 3 skin reactions would be able to be used to demonstrate the absence of skin irritation. This is an appropriate outcome because category 3 skin reactions are not considered hazardous in Australia.

These extra options should mean that the absence of hazard characteristics can be demonstrated for more introductions.

Slide 50

We are also proposing a change relating to the options in the Guidelines to demonstrate the absence of Specific Target Organ Toxicity after Repeated Exposure for high molecular weight polymers. This hazard characteristic is found in human health hazard band B.

Under this proposal, we would remove the current option where the absence of this hazard can be demonstrated by the polymer not having the skin corrosion hazard characteristic. It would be replaced by an option where the proportion of low molecular weight species in the polymer should be considered. Specifically, an introducer should demonstrate that less than 5% of molecules have a molecular weight lower than 1000 g/mol, and less than 2% of molecules have a molecular weight lower than 500 g/mol. This is an appropriate change because higher levels of low molecular weight species mean that the polymer has greater potential to be of systemic toxicity concern.
 
It should be noted that this addition would mainly impact on introducers of high molecular weight polymers where the human health exposure band is 4. This proposal would also mean that current introducers of high molecular weight polymers that relied on the skin corrosion option at step 4 of the categorisation process could no longer rely on this information. For such introductions to be categorised as exempted or reported after the amended Guidelines take effect, introducers would instead need to consider other information, such as the level of low molecular weight species. It is only expected to impact a very small number of introducers. We would contact introducers who may be affected by this change, prior to amendments taking effect.

Slide 51

Bioaccumulation potential is a hazard characteristic in environment hazard band A. We propose to remove ready biodegradability test results from the available options for demonstrating the absence of the bioaccumulation potential hazard characteristic. Demonstrating the absence of bioaccumulation potential is only necessary for introductions with an environment exposure band of 3 or 4, where the introducer wants to get to an outcome of very low risk, and thus to be in the exempted introduction category. Note that the results of ready biodegradability tests would still be able to be used for several other environment hazard characteristics in accordance with the Guidelines.

We are proposing this change because the ready biodegradability of a chemical by micro-organisms doesn’t mean that the chemical could not bioaccumulate in other organisms. 

If this change is made, introducers would have fewer options available to them for meeting the information requirement for bioaccumulation potential, and instead would need to use other information to meet the requirements for this end-point. There are a number of other ‘non-study’ options available in the Guidelines, including consideration of molecular weight, levels of low molecular weight species for polymers and the use of in silico predictions. The proposal is only expected to impact a very small number of introducers. We would contact introducers who may be affected by this change, prior to amendments taking effect. 

Slide 52

Our next proposed amendment relates to annual declaration requirements. We propose to ask introducers of exempted introductions to specify which types of exempted introductions they have introduced when they complete their Annual Declaration online form at the end of the registration year.  

Slide 53

The annual declaration is a requirement for all introducers of industrial chemicals. It requires an introducer to identify the introduction categories of the chemicals they imported or manufactured during an AICIS registration year. Namely: listed, exempted, reported, assessed, and commercial evaluation. They also need to confirm that all their introductions were authorised under our laws. 

Our proposal applies only to introducers of exempted introductions: when completing an annual declaration, introducers of exempted introductions would be asked to specify which type of exempted introduction they used. Knowing which types of exempted introductions are being used will provide valuable information for appropriately targeting our compliance activity where it is most needed.

Slide 54

If the proposed change goes ahead, when an introducer submits their annual declaration in AICIS Business Services and selects ‘exempted introduction’, a new checkbox list will appear with these options, which are the 8 different types of exempted introductions. The introducer would need to click on each type that is relevant to their importation or manufacture for that registration year. 

The proposed change would mean that an introducer’s annual declaration will require slightly more information to be provided, but only for those that used the exempted introduction category. Only the types of exempted introduction would be required – not detailed information about the specific chemicals. We expect that most introducers would already know and have records of the information that would be required here. These changes will apply to annual declarations that are made on or after the amended Rules come into force.

Exempted introductions are those that are categorised as very low risk to human health and the environment, and they have a corresponding lower level of pre-introduction AICIS requirements because of this. To ensure that exempted introductions are categorised correctly, it's important that we are able to effectively monitor them and check the categorisation criteria have been met. Only the 3 types of exempted introductions that are shown at the top of this slide in orange text require a post introduction declaration to be submitted. A post introduction declaration is a separate requirement to the annual declaration and requires information to be given to AICIS about the introduction of the chemical. This proposed change will allow us to know which types of exempted introductions an introducer uses so we are able to more easily verify whether introducers are complying with their obligation to submit a post-introduction declaration.

Slide 55

To give an example. It has just past the end of the AICIS registration year and Company XYZ wants to do their annual declaration. Under the current Rules, when they go into the AICIS Business Services portal, for their annual declaration they need to select the boxes of the introduction categories that they used during the past registration year. They know they introduced using the listed category and the reported category, and that they had several exempted introductions that they commenced introducing during that year. So, they tick the appropriate boxes and continue on with the remaining parts of their annual declaration to confirm that their introductions were authorised.

Slide 56

Under the proposed rules, the same company would still first select the boxes for listed, reported and exempted. Because they select exempted, they would be given a set of check boxes with the types of exempted introductions. They know that the types of exempted introductions they used are 'introductions where the highest indicative risk is very low', 'polymers of low concern' and 'introductions for R&D only'. So they tick these boxes and then go on to the rest of their declaration, which would be the same as it currently is. 
Now I'll hand back over to Graeme.

Slide 57

In summary, we’re proposing a number of changes to the Rules and Guidelines to make requirements more practicable and proportionate to the risk of the introductions. 
Many of the proposals are intended to address stakeholder advice that certain requirements are challenging to comply with. For example, we’re proposing:

• to replace written undertakings with records that’ll make compliance easier for listed, exempted and reported introductions;
• expand the circumstances in which INCI names can be used for reporting and record keeping purposes; and
• changes to the categorisation criteria to benefit introducers of chemicals in flavour and fragrance blends.

We’re also proposing some changes to strengthen categorisation criteria and reporting requirements to protect Australians and the environment, and some minor proposals to clarify some specific information and requirements that we haven’t detailed today. 

Slide 58

A reminder that you can find information about the proposed amendments to the Rules and Guidelines in the explanatory information on our website. This material is available in both online and offline versions. The content of these two versions is the same, with the offline version just being a collation of the online content into a single document, for convenience.

The explanatory information focusses on what is being proposed, and why, and suggests impacts of the proposed changes.

For the Rules proposals, you can also look at the exposure draft that can be downloaded from our website. This provides full details of the words and sections of the rules that would be changed, allowing stakeholders to see exactly what the changes would entail. 

Note that the exposure draft could be significantly amended after feedback has been received and considered.

There's no equivalent to an exposure draft for the proposed changes to the Categorisation Guidelines – the details of these changes are in the explanatory material only. We would also publish a notice of Guideline amendments prior to any changes coming into effect.

To provide feedback - you can comment on any or all of the proposals via our website. There is a single form that allows you to comment on multiple proposals, or there is a form at the bottom of each online proposal to allow you to have your say on single proposals. 

All views will be considered once the consultation period closes and before the Minister makes changes to the Rules. The detail and type of feedback that we receive will impact on what the next steps are and how long these steps will take, however, if the Minister agrees to amend the Rules, it is expected that amendments would take effect from April 2024. Any amendments to the Guidelines would also take effect at this time. 

Slide 59

So that brings us to the end of the formal part of today’s webinar. A reminder that the consultation period finishes on the 9th of November, and you can submit your feedback about the consultation through our website up until this date.