Response to feedback on proposed changes to AICIS categorisation, reporting & record keeping requirements

Overview

From September to November 2023, we asked for feedback on a suite of changes to the Industrial Chemicals (General) Rules 2019 (Rules). The proposals related to categorisation of chemical introductions as well as reporting and record keeping requirements for listed, exempted and reported introductions. These proposals were designed to:

• address some of the challenges that stakeholders told us they experienced when trying to meet their obligations
• strengthen the categorisation criteria and/or reporting requirements to better protect human health and the environment or clarify the requirements.

Proposals that would benefit introducers were based on mechanisms that could lower regulatory burden while maintaining regulatory intent. We received over 40 stakeholder submissions about these proposals. 

Amended Rules will commence 24 April 2024
In general, stakeholders supported the proposed changes and gave valuable feedback on areas they believed could be improved. We respond to feedback we received below. The below table provides a summary of notable changes made based on consideration of feedback received.

During these consultations, we received some feedback or questions that were outside the scope of these consultations or specific to certain stakeholders. We have not covered those issues below. Feedback on matters outside the scope of the planned amendments will be considered in the future. 

We continue to explore options to resolve difficulties that industry stakeholders told us they face when trying to meet their ‘specific information requirement’ obligations, where the chemical identity is held by an overseas supplier or manufacturer. Although we don’t cover this topic here, this work is ongoing and we will continue to engage with stakeholders.

In several submissions, we were asked questions about existing requirements and some asked if we could provide additional record-keeping templates. We will consider revising our website guidance to help clarify requirements and make it easier to comply with record-keeping obligations.

More guidance will be available

We will publish new web guidance when the new rules take effect. Until then, introducers can look at the original proposals for information about categorising introductions (such as manufacture of soaps) and for examples of the types of information that can be kept in different record-keeping circumstances.
  
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Listed introductions: more practicable record-keeping requirements (Schedule 1, Part 1)

From 24 April, changes to record-keeping requirements for listed introductions will take effect as described in the original proposals, except for the ones outlined below which were revised following stakeholder feedback.

Feedback we received for listed introductions – option 5

Some submissions mentioned that proposed record-keeping requirements for listed introductions could be difficult to comply with, where the introducer does not know the CAS number, CAS name, IUPAC name, eligible INCI plant extract name or AACN for their chemical (but their chemical supplier/manufacturer knows this information).

For chemicals introduced in flavour or fragrance blends, we were asked if the option to hold the blend name could be amended so as not to require that chemicals are on the IFRA Transparency List.

Our response

We considered the feedback and changes were made to option 5 of the original proposal for listed introductions:

• Simplified the record-keeping requirements around the name(s) that must be held, where the introducer does not know CAS number, CAS name, IUPAC name, eligible INCI plant extract name nor an AACN. This includes amending the proposed option related to chemicals in flavour or fragrance blends not to require that chemicals are on the IFRA Transparency List. 
• Removed the proposed requirement to keep records related to maximum concentration, introduction volume and known hazard classification. 

These changes were made after further consideration of what is reasonable and appropriate for the Rules to require that an introducer holds for listed introductions. The amendments provide increased flexibility for introducers whilst ensuring that AICIS has adequate information to accurately identify the Inventory listing for a chemical.

Revised option 5 after stakeholder feedback

There are 5 options related to chemical identity and introducers will be expected to fulfil options 1,2,3 or 4 (in that order), before resorting to option 5. Options 1-4 relate to the introducer knowing the CAS number, CAS name, IUPAC name, eligible INCI plant extract name and/or AACN for their chemical. Otherwise, at option 5, they need to keep:

• A record that shows the chemical is listed on the Inventory (generally provided by the chemical supplier).
• One of the following:
  • Names they know the chemical by. This could be a Trade Name.
  • Names of any products they’ve imported that contain the industrial chemical.
  • Name of the flavour or fragrance blend that the industrial chemical is to be introduced as part of.
• The name of the person or business who they reasonably believe would supply the CAS number (if assigned), and the CAS name or IUPAC name of the chemical, if requested by the introducer, following a request from the Executive Director. They will also need a record of the reasons why they believe this. For example, this could be information in an email from the chemical identity holder or minutes of a meeting.  

Current record keeping requirements relating to any terms of listing for a chemical will remain. This means introducers must keep records that prove they are complying with any applicable terms of listing for a chemical:

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

Other feedback we received for listed introductions (presented in Q and A format)

1. If I know the INCI name of a chemical, do I need to know who can supply the CAS number for the chemical that I’m introducing?
   
   Yes – unless the introducer holds an ‘eligible INCI plant extract name’ for their chemical.
   
   To be a listed introduction under the Industrial Chemicals Act 2019, the chemical must be on the Inventory and introduced in accordance with the terms of the Inventory listing. A term of listing includes the CAS name and CAS number for the chemical.
   
   Amendments to the Rules include that if an ‘eligible INCI plant extract name’ for a chemical is held, then the introducer doesn’t need to know who can provide the CAS number. This is as long as they keep records to show that the chemical is on the Inventory and it is being introduced or used in accordance with any terms of listing.
   
   Some stakeholders told us that there are many chemicals used in cosmetics that have an INCI name, but no corresponding CAS number or name. If a CAS number or name has not been assigned to a chemical, then it is unlikely to be on the Inventory. This is because a term of listing includes the CAS name and CAS number for the chemical.
    
2. I comply with current written undertaking rules for listed introductions – can the requirements be amended so that these remain valid and I don’t need to source additional information to be compliant?
   
   Yes – if an introducer is meeting the record keeping requirements in the current Rules (including holding of a written undertaking from their chemical identity holder), then they will meet the requirements in the amended Rules.
   
   Several stakeholders indicated a preference for the holding of written undertakings – if an introducer chooses, these could continue to be sourced for future chemical introductions. The amended Rules create greater flexibility and options for the types of records that may be kept.
    
3. Can there be a transition period for listed introduction changes, so I make sure I comply?
   
   This is not needed because record keeping requirements have been simplified. If you are meeting the current record keeping requirements in the Rules for your listed introduction, you will also meet the amended Rules requirements.

Exempted and reported introductions: more practicable requirements (Schedule 1, Part 2)

From 24 April, changes to reporting and record-keeping requirements for exempted and reported introductions will take effect as described in the original proposals, except for the ones outlined below which were revised following stakeholder feedback.

Feedback we received related to INCI names for exempted / reported introductions

Some submissions mentioned there should be greater acceptance of INCI names for exempted and reported introductions. For example, in situations where a CAS number or name has not been assigned to a chemical used in a cosmetic and the introducer doesn’t know the IUPAC name.

Our response

There will be more instances where introducers can keep/provide INCI names to meet their reporting and record keeping requirements, where CAS or IUPAC name is not known. 

Under the original proposal – if the CAS or IUPAC name for a chemical is not known – there were already more instances where the introducer could provide or keep INCI names without them needing to have details of the person/business that would provide the CAS or IUPAC name for the chemical.

Post-consultation, we further considered what requirements are reasonable and appropriate for the Rules to require introducers to hold/provide for each type of exempted and reported introduction. The circumstances where the introducer can keep or provide the INCI name have since been expanded – see below.

INCI names will be able to be provided/kept for more types of exempted and reported introductions

INCI names will also be able to be kept or provided for these types of exempted/reported introductions, where CAS or IUPAC name is not known:

• Chemicals imported and subsequently exported (at step 2 of the categorisation process)
• Research and development (at step 2 and 3 of categorisation)
• Highest indicative risk is low risk – all reported introductions of this type (human health exposure band 1-4 and environment exposure band 1-4)

Consistent with the Rules changes that we consulted on, where appropriate for the types of introductions and proportionate to risk, there will still be instances in the amended Rules where either 1 or 2 applies:

1. An ‘eligible INCI plant extract name’ (meaning only a subset of INCI names) could be provided/kept in the absence of a CAS/IUPAC name.
2. Introducer can provide/keep any INCI name, but they must also know who can supply more information about the chemical’s identity (such as the CAS number, CAS name or IUPAC name) - see example below.

Example: Introduction of a polymer where the introducer only knows the INCI name
 
Polymer Products Pty Ltd are planning to introduce a polymer.

They know the INCI name but don’t know any details such as the CAS or IUPAC name or polymer composition and molecular weight. They also don’t know who can provide this detailed information about the polymer to AICIS, if asked.

Polymer Products Pty Ltd cannot categorise their introduction as exempted, based on the polymer being a polymer of low concern (PLC) at step 2 of the categorisation process because they have insufficient information to show that it meets the PLC criteria and they don’t know who can provide this information to AICIS, if requested.

Polymer Products Pty Ltd should continue with the categorisation process to see if they have enough information: 

• for their introduction to be categorised as exempted or reported at other steps of the categorisation process 
• to meet their reporting and record-keeping requirements.

Feedback we received about R&D introductions

Some submissions asked about the possibility of reduced record-keeping requirements for certain research and development (R&D) introductions.

Our response

The amended Rules will give more options and flexibility to introducers of chemicals for R&D. For example, INCI names can be reported/kept, and written undertakings have been replaced with more practical record keeping requirements.

However, amendments to the exposure-related records are outside the scope of the current amendments. As is the case now, an R&D introducer will still need to keep records showing that the criteria at either step 2 or 3 of the categorisation process, to limit exposure of the chemical to humans and the environment, are being met. If they can’t demonstrate that they meet the R&D criteria, they could continue to work through steps 4-6 of the categorisation process to check if they have enough information to categorise their introduction and meet reporting and record-keeping requirements.  

Other feedback we received for exempted / reported introductions (presented in Q and A format)

1. Why is the term ‘proper name’ in the Rules being replaced in most reported and exempted introduction circumstances?
   
   Under the amended Rules, the term ‘proper name’ will be replaced in most instances for reported and exempted introductions with the precise types of chemical names that would be accepted for each type of introduction. This follows consideration of what is reasonable and appropriate for the Rules to require introducers to hold/provide for each type of exempted and reported introduction and allows for expanded circumstances where INCI names could be used. These changes give more clarity and certainty for introducers and will make it easier for them to meet their reporting and record keeping obligations.
    

2. Do I still need to supply the AICIS Business (NIC) ID for the person who holds the identity of my chemical?
   
   Introducers need to supply the AICIS Business ID so we can contact a chemical identity holder directly for information relating to a pre-introduction report or post-introduction declaration. The instances where introducers will need to do this has been reduced – see examples below.
    

   Examples: Pre-introduction report – ‘highest indicative risk is low risk’ – AICIS Business ID is or is not needed
   
   1: Introducer does not know the CAS or IUPAC name, but they can supply the INCI name.
   
   Introducer will not need to provide the AICIS Business ID of the person who holds the CAS/IUPAC name of the chemical.
   
   2: Introducer does not know the CAS or IUPAC name and they do not know the INCI name.
   
   Introducer will need to provide the AICIS Business ID of the person who holds the CAS/IUPAC name of the chemical. 

3. I comply with written undertaking requirements in the current Rules. Will written undertakings for exempted and reported introductions still be valid under the amended Rules?
   
   Yes. If an introducer is meeting the record-keeping requirements in the current Rules, including holding a written undertaking from the information holder, they will continue to meet requirements under the amended Rules. 

Soap makers: reducing regulatory obligations (Schedule 1, Part 3)

From 24 April, changes to reduce obligations for soap makers will take effect as described in the original proposals.

Feedback we received about introduction of soaps

Some stakeholders asked us if reduced obligations for soap manufacturers could also be considered for soap importers.

Our response

No. The existing requirements for manufacture of soaps by small or home-based businesses are not proportionate to the risk of the introductions. The amendments create more fit-for-purpose regulation for these introductions. 

Feedback we received about the volume thresholds

Some stakeholders asked us to consider increasing the maximum volume thresholds for excluded (from 10 kg) and exempted (from 100 kg) introductions.

Our response

The maximum volume thresholds will not change from those proposed in the original consultation. The requirements under the amended Rules are proportionate to the risk of the introductions. 

Note: the thresholds will apply to each oil or fat that is used to manufacture soap in a registration year. For exempted introductions as an example, an introducer can use 100 kg of oil A, 100 kg of oil B, 100 kg of oil C and so on.

Feedback we received about ‘other’ soap ingredients

Some submissions asked whether ‘other’ chemical ingredients used in manufactured soap also had reduced obligations.

Our response

The reduced requirements apply only to the soap-chemical that is being made by mixing lye (sodium hydroxide or potassium hydroxide) with an oil or fat. 

If a soap maker uses other chemical ingredients to blend with the manufactured soap chemical, such as a fragrance, then the introducer must comply with obligations under AICIS for those other ingredients. These will depend on whether they are:

• imported or manufactured (obligations under AICIS apply) or
• sourced from local suppliers (no obligations under AICIS related to those chemicals – these will already have been met by the supplier at the point of entry into Australia).

More guidance will be available

We will publish new and updated web guidance for soap manufacturers when the new rules and guidelines take effect. Until then, categorisation information and examples are provided in the original proposals.  

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Flavour or fragrance blend chemicals: expanding the eligibility criteria (Schedule 1, Part 4)

From 24 April, changes to eligibility criteria for low-risk flavour or fragrance blend introductions in the reported category will take effect as described in the original proposals, except for the ones outlined below which were revised following stakeholder feedback.

Feedback we received about chemicals being on the IFRA Transparency List

Some feedback indicated that the proposal could be improved if it were amended so that chemicals not on the IFRA Transparency List could also meet the expanded criteria for low-risk flavour or fragrance blend introductions in the reported category.

Our response

The criterion related to the chemical being on the IFRA Transparency List has been amended after reviewing feedback. A chemical can be either on the IFRA Transparency List or AICIS must receive certain details about the chemical before introduction – see below.

Changes made to this criterion after stakeholder feedback

Under the amended Rules, and consistent with the requirement for current low-risk flavour or fragrance blend introductions (step 3 of the categorisation process), either A or B must apply.

A.    the chemical must be on the IFRA Transparency List at the time an introducer submits their pre-introduction report

B.    information about the chemical introduction must be given to AICIS before the chemical (in the blend) is introduced:
       o    the CAS number (if assigned)
       o    the CAS name, the IUPAC name, or an eligible INCI plant extract name
       o    any hazard characteristics of the chemical that are known to the person providing
             the information
       o    the maximum concentration of the chemical in the blend, at both introduction and
             end use
       o    the name by which the blend containing the chemical is known to the introducer.

This change was made after further considering what is reasonable and appropriate for the categorisation of the introduction of chemicals in flavour and fragrance blends as reported at step 3 of the categorisation process.

Feedback we received about other flavour or fragrance blend criteria

Some feedback asked for the expanded criteria to be amended by removing requirements around concentration, volumes and known hazards. In other words, to only require that chemicals are on the IFRA Transparency List and used in accordance with IFRA standards.

Our response

The criteria related to concentration, volumes and known hazards have not been removed. These safeguards are included to ensure sufficient protection of human health and the environment. Removing them would not be risk-proportionate or appropriate for introductions categorised as reported (low risk) at step 3 of the categorisation process, with minimal reporting and record keeping requirements.

Feedback we received about flavour and fragrance blends

Some submissions asked whether the criteria could be amended to apply to the flavour and fragrance blend, instead of applying to chemicals in the blend.

Our response

No, it is not possible to amend the criteria so that it applies to the blend. This is because the Industrial Chemicals Act 2019 regulates the introduction of chemicals, not the products or mixtures containing them.

Other feedback we received for flavour or fragrance blend introductions  

Can written undertakings still be provided to Australian importers?

Yes – while there will be greater flexibility and options for the types of records that may be kept, chemical suppliers can choose to continue to provide them to Australian importers as a way for the importer to meet their record keeping requirements under the amended Rules.

Fluorinated chemicals: categorisation changes for health and environmental protection (Schedule 1, Part 7)

From 24 April, categorisation changes for fluorinated chemicals will take effect as described in the original proposals.

Can there be a transition period for chemical introductions that are currently in the reported category, but will be categorised as assessed following the Rules amendments?

No, there will not be a transition period. The amendments take effect from 24 April 2024. 

Fluorinated chemicals are of high concern to human health and the environment. The changes will clarify the types of chemicals, including ‘next generation’ type fluorinated chemicals, that warrant an AICIS assessment and approval before anyone can introduce them into Australia.

Only a small number of businesses will be affected by these changes based on information provided in current pre-introduction reports for reported introductions. We have already contacted those introducers about the amendments.

Chemicals containing hazardous elements added to human health hazard band C (Schedule 1, Part 8)

From 24 April, changes to add certain chemicals to human health hazard band C will take effect as described in the original proposals.

If chemicals containing these elements would already have one or more of the current hazard characteristics in human health hazard band C, what is the benefit of specifically adding the elements to human health hazard band C? 

Adding these elements to human health hazard band C will give clarity for introducers and make it easier for them to work out the introduction category. It will also reduce the likelihood of introducers incorrectly, or inadvertently, categorising introductions of chemicals containing these elements as low or very low risk.

Exempted introductions: annual declaration change to improve AICIS monitoring (Schedule 1, Part 9)

From 24 April, annual declaration changes will take effect as described in the original proposals.

Why did AICIS consult on this again? You asked for feedback in 2021 but the proposal did not proceed (Rules were not amended back then).

We revisited this and carefully weighed up the effort and burden to introducers against the benefits to Australians and the environment from targeted compliance monitoring that would result from this change.

The extra information will help us better prioritise our compliance monitoring activities. It will also allow us to more easily verify whether introducers that are required to submit a post-introduction declaration are complying with that obligation.

Minor changes to clarify information and requirements (Schedule 1, Parts 10-12)

From 24 April, the minor Rules changes to clarify information and requirements will take effect as described in the original proposals, except for the ones outlined below which were revised following stakeholder feedback.

Feedback we received about the ‘biological chemical’ definition

We received feedback indicating that the proposed biological chemical definition could be improved if it were amended to replace ‘extracted from’ with ‘derived from’. 

We also received feedback asking if it was necessary that the biological chemical definition includes a chemical that “is a living or once-living organism, without further modification”.

Our response

• ‘extracted from’ has been replaced with ‘derived from’.
• ‘is a living or once-living organism, without further modification’ has been removed from the definition.

These changes were made after reviewing the feedback and considering the intended scope of the definition. See the full amended definition below.

Revised definition of biological chemical after stakeholder feedback

Biological chemical means an industrial chemical that: 
(a)    is derived from a living or once-living organism, without further modification; or 
(b)    is produced by a living or once-living organism, without further modification.

Feedback we received about the PBT criteria 

Why change the AICIS persistent, bioaccumulative and toxic (PBT) criteria to the Australian environmental criteria for Persistent, Bioaccumulative and/or Toxic Chemicals at step 3 of the categorisation process?

Our response

The Australian environmental criteria for Persistent, Bioaccumulative and/or Toxic Chemicals were finalised and published after the original Rules were drafted. 

The criteria in the two information sources are very similar. But referring to these criteria may make it easier for introducers when working out if their introduction can be reported (at step 3 of the categorisation process).

Date published: 21 March 2024