Webinar video now available - Overview of proposed changes to categorisation, reporting and record keeping

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.