Our response to feedback on proposed changes to AICIS Categorisation Guidelines

Overview 

We asked for feedback on proposed changes to the Industrial Chemicals Categorisation Guidelines (the Guidelines) in 2 separate consultations from September to November 2023 (which included both Guidelines and Rules proposals) and from January to February 2024 (only Guidelines proposals). These proposals were designed to:

• update and refine certain technical aspects related to categorisation of chemical introductions
• clarify information and requirements. 

We received more than 10 submissions relating to the Guidelines proposals from each of these consultations.

Commencement of changes to the Guidelines

Feedback from stakeholders informed the decision that some changes to the Guidelines commence as first suggested, in April, and others commence later, which will be September, as set out below.

• 24 April 2024: Most changes will commence on this date, consistent with the commencement of Rules amendments.
• 24 September 2024: Commencement of certain changes that could take introducers more time to prepare for.

This table is a summary of the Guidelines consultation topics and what changes we made after we considered your feedback. It also outlines whether the April or September date applies to the change. We explore these topics and your feedback further below.

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.  

More guidance will be available

We will publish new web guidance when the new Guidelines take effect. 

Until then, introducers can look at the full details of the proposals in our consultation material and the final draft of version 2 of the Guidelines that will take effect on 24 April 2024.

Changes to the Guidelines

List of chemicals with high hazards for categorisation

The List of chemicals with high hazards for categorisation (the List) is a list of chemicals that trusted national and international sources consider to be highly hazardous to human health or the environment, with hazard characteristics that are in the highest AICIS hazard bands (human health hazard band C or environment hazard band C or D). At steps 4 and 5 of the categorisation process, when working out if an introduction can be categorised as exempted (very low risk) or reported (low risk), in most circumstances the Guidelines require the List to be checked in order to demonstrate that a chemical does not have these high concern hazard characteristics.  To date, the List has included by default all salts and esters of each chemical specifically included on the List.

Changes to the Guidelines text

Proposal  

We proposed to add/change text in part 6 and appendix 8.1 of the Guidelines that more clearly align with the purpose/function of the List and how it is accessed in practice, as well as providing greater clarity around what substances have been included in the List, for all the sources.

We did not receive feedback directly related to this proposal.

The proposed amendment has been made and will commence on 24 April 2024. This means that the Guidelines will be amended as shown in part 6 and appendix 8.1 of the final draft of version 2 of the Guidelines.  

Adding chemicals to the List based on current sources  

Proposal  

We planned to add chemicals to the List that have been added to the information sources for the List (appendix 8.1 of the Guidelines) since it was published in 2020. This will add nearly 600 unique entries to the List. Future updates to the List were planned to be made yearly, with a 3-month notice period given in advance of an update taking effect.

Summary of feedback  

Some stakeholders questioned the implications of adding substances to the List that are already in commerce.  

Our response

The additions to the List will be made. However, to allow introducers to prepare for this change, these additions to the List will be made on 24 September 2024.  

View additions to the List to be made on 24 September 2024  

Additions to the List of chemicals with high hazards 26 March 2024.XLSX

AICIS will contact introducers that we can identify as being affected by the additions and guide them through the required changes.  

Future updates to the List will be made yearly, with a 6-month notice period.

The substances that will be added to the List are considered to be highly hazardous (i.e. have a human health hazard band C or environment hazard band D or C hazard characteristic) based on trusted domestic or international sources. Adding these chemicals to the List will make it quicker and easier for introducers to work out that their chemical has high concern hazard characteristics and decrease the likelihood of incorrectly or inadvertently miscategorising chemical introductions into a lower introduction category. 

If these additions to the List make an introducer aware of a high concern hazard characteristic of a chemical they are introducing, in most circumstances this will mean a change to the introduction category from exempted or reported to assessed. This is an appropriate and correct categorisation outcome for chemicals that have been established internationally to be highly hazardous.

Adding information sources  

Proposal  

We proposed to:

• add the European Commission Endocrine Disruptor List (List I) to appendix 8.1 of the Guidelines as an information source for the List of chemicals with high hazards for categorisation, to capture chemicals that have been identified as endocrine disruptors at the EU level.
• add chemicals to the List, at the discretion of the Executive Director of AICIS, that have been assessed or evaluated by AICIS and determined to possess a hazard characteristic in human health hazard band C or environment hazard bands D or C.

Summary of feedback  

One submission expressed concern at the addition of the European Commission Endocrine Disruptor List based on the process by which chemicals are added to this list. In contrast, another submission indicated their agreement with the addition of this list.

Some submissions sought more clarity on the process for AICIS assessment or evaluation outcomes to be added to the List. Some were concerned that other introducers might be impacted by these additions but not have the opportunity to input into the decisions that are made.

Our response

The proposed amendment to add the European Endocrine Disruptor List to appendix 8.1 of the Guidelines will be made. To allow introducers to prepare for this change, the additions to the List and the update to appendix 8.1 will be made on 24 September 2024. This means that appendix 8.1 of the Guidelines will be amended on 24 September 2024 as shown below. The substances that will be added at this time due to their presence on this list source are included in the additions to the List to be made on 24 September. 

European Commission Endocrine Disruptor List – list of substances identified as endocrine disruptors. Substances included on the list of chemicals with high hazards for categorisation are those on List I, identified as endocrine disruptors at EU level.

The proposed amendment to enable AICIS assessment or evaluation outcomes to be added to the List will be made. This means that the Guidelines will be amended as shown in appendix 8.1 of the final draft of version 2 of the Guidelines.  However, no such entries will be added to the List in this current round of updates. 

AICIS will consider the process for these additions to be made and the chemicals that are appropriate to add. Chemicals may be added to the List during future updates to the Guidelines.

Removing certain chemicals from the List

Proposal  

We proposed to remove the following information sources from the List:  

1. Class II chemicals on the Chemical Substances Control Law of Japan (CSCL)
2. Schedule 1 in the Government of Canada Toxic Substances List  
3. Substances with ‘equivalent level of concern’ in the European Chemicals Agency (ECHA) REACH Annex XIV Authorisation
4. Substances with ‘equivalent level of concern’ in the EU Substances of Very High Concern (SVHC)

We proposed to remove the following entries from the List as they did not align with the hazard characteristics in human health hazard band C:

• Substances with ‘respiratory sensitising properties’ in the EU SVHC
• Group 3 carcinogens on the International Agency for Research on Cancer (IARC) Monographs

We also proposed to remove entries from the List that are not industrial chemicals, i.e. those that:  

• are not a chemical element
• are not a compound or complex of a chemical element
• are not a UVCB substance
• meet the definition of a radioactive chemical in the Industrial Chemicals (General) Rules 2019.

We did not publish as part of our consultations the entries from the List that would be removed.  

Summary of feedback  

There was general support for the proposed removals. Some stakeholders suggested other entries that should be removed from the List based on them not being industrial chemicals, such as viruses, medicines, etc.  

Our response

The proposed amendments to remove the information sources from the List will be made and will commence on 24 April 2024. This means that the Guidelines will be amended as shown in appendix 8.1 of the final draft of version 2 of the Guidelines. The entries that will be removed from the List are shown in Attachment 1 to this document.

The proposed amendments to remove entries that are not industrial chemicals will be made and will commence on 24 April 2024. The entries that will be removed from the List will be identified when the updated List is published on 24 April 2024. The entries removed are those that are unambiguously not industrial chemicals. Some entries suggested to us for removal have been retained as industrial uses are conceivable. AICIS may remove entries in the future if they can unambiguously be shown not to be industrial chemicals.

High hazard esters and salts of chemicals on the List

Proposal  

We proposed to reduce regulatory burden by making it quicker and easier for introducers to check the List by:

1. Removing the current requirement to check for esters and salts of most chemicals on the List
2. Separately specifying the chemicals that introducers must check to see if their chemical is an ester or salt of those specified chemicals
3. Defining any exceptions that apply for the esters and salts

Summary of feedback on the proposal itself

Stakeholders supported this proposal as it narrows the scope of the additional checks needed for esters and salts of chemicals on the List.  

Our response

The proposed amendment has been made and will commence on 24 April 2024. This means the Guidelines will be amended as shown in parts 6.3, 6.4, 6.5, 6.6, 6.7, 6.25, 6.26, 6.27, and 6.28 of the final draft of version 2 of the Guidelines.

Other feedback relating to the high hazard esters and salts of chemicals on the List

Question: Why do additional checks need to be done for esters and salts of chemicals on the List?  

The prediction of hazards based on ready conversion to chemicals with known hazards is well established nationally and internationally. After absorption, esters undergo rapid hydrolysis by non-specific esterases (enzymes) present in the body, and salts are expected to dissociate in biological media.  Data on the parent acid/base for salts and expected metabolites for esters (acid and alcohols) are commonly used to inform human health assessments. 

In the environment, several classes of esters can undergo hydrolysis and/or other degradation. Salts, acids, and bases will dissociate, depending on the chemical. These processes can produce degradants or species that are hazardous to the environment. Environmental risk assessment of esters and salts will often require assessing the hazards of the parent chemical and the hazards of any degradants/species that may be formed.

A similar approach is taken in the Poison Standard, where a reference to a substance is defined as including every salt, active principle or derivative of the substance, including esters and ethers, and every salt of such an active principle or derivative.

Question: What is the justification for the certain esters and salts that will be specified in the Guidelines as requiring the additional checks?  

The targeted list of chemicals for additional salts and esters checks was identified by considering:

• whether the chemicals would be categorised as medium to high risk based on other parts of the legislation (and so it should not be necessary to include it in the targeted list of salts and esters)
• whether the salt or ester of the chemical would be likely to be introduced into Australia for industrial use  
• the available toxicological data and information on national/international regulatory actions on identified salts and esters. This analysis also informed whether any exception criteria (such as molecular weight cut-offs) may be applicable. 

Question: Will CAS numbers be provided for the chemicals that will require checking for esters and salts? 

Most of these chemicals had their CAS numbers given in our consultation material (Jan – Feb 2024). Only those where there could be various, or multiple CAS numbers associated with them were not identified by CAS number. Some of the entries relate to classes of chemicals with multiple CAS numbers associated with those classes.  It is not possible to identify all the CAS numbers associated with these entries. AICIS may add such CAS numbers to the entries during future updates to the Guidelines.

Other feedback relating to the List

Question: Why are there chemicals on the List that are already risk managed through other mechanisms?

Substances on the List are considered to be highly hazardous (i.e. have a human health hazard band C or environment hazard band D or C hazard characteristic) based on trusted domestic or international sources. It is appropriate that the risks of their industrial uses be assessed by AICIS in most circumstances in which an introduction is being categorised at steps 4 and 5 of the categorisation process.

Question: Will CAS numbers be provided for all substances on the List?

No. Many of the information sources that the List is drawn from include entries without CAS numbers. Some of the entries relate to classes of chemicals with multiple CAS numbers associated with those classes. There may be some entries where it is possible to unambiguously determine what the CAS number should be. AICIS may add such CAS numbers to these entries during future updates to the Guidelines.  

CAS number is not the only means by which the List can be searched. Even if the CAS number is found on the List, it is important that an introducer also checks the chemical name column to ensure that their substance is covered by the List entry and thus is considered to have the high concern hazard characteristics. 

Example

Margosa, ext. (CAS number 84696-25-3) is a chemical that will be added to the List on 24 September 2024. An introducer could find its entry on the List when searching by its CAS number. The CAS number covers multiple extracts. The chemical name column of its List entry reads ‘Margosa,ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents]’  i.e. it specifies that only this extract has been found to have high concern hazard characteristics. Other forms of Margosa ext. would not currently be “on the List”.  

Question: Why are chemicals that are listed on the Inventory being retained on the list of chemicals with high hazards for categorisation?  

The List will retain Inventory-listed chemicals. AICIS will further consider this suggestion in the future. Some of the listed chemicals may have certain terms of listing that mean some introductions of the chemical may still need to be categorised.  The List clearly shows whether a chemical is listed publicly on the AICIS Inventory.

Question: In the list of additions that AICIS proposed adding to the List based on updates to the information sources there appeared to be many duplicates of the same chemical. Why is AICIS including these duplicate chemicals?

This was a result of the way the list was presented rather than there being duplicates. When we presented the list of proposed additions in the consultation each chemical had a separate entry for each information source that it was included on, hence some chemicals had more than one row in the spreadsheet. Note that the additions to the List to be made in September 2024 has retained this format.  

Question: Can substances that are included on the List be introduced in the listed category?  

Yes.  If your chemical is on the Inventory, its introduction is a listed introduction as long as you meet the terms of the inventory listing.  

If your introduction does not meet the terms of the inventory listing (for example, you are introducing outside the parameters of a defined scope of assessment), you may be required to categorise accordingly.    

Options on how to show the absence of hazards in categorisation

More models for in silico predictions and added test guideline for ready biodegradability

Proposal  

We proposed to add the following in silico models to appendix 8.2 of the Guidelines:

1. iSafeRat® Desktop added as an option in:  
   1. Table 1 of appendix 8.2 - In silico models for human health hazard characteristics, for eye damage/eye irritation
   2. Table 2 of appendix 8.2 – In silico models for environment hazard characteristics, for acute aquatic toxicity and bioaccumulation (as a function of Log Kow)  
2. OASIS-CATALOGIC  - added as an option in Table 2 of appendix 8.2 – In silico models for environment hazard characteristics, for persistence (as a function of half-life), bioaccumulation (as a function of Log Kow), and acute aquatic toxicity.  

We also proposed to add OECD guideline no. 310 as an acceptable test guideline in appendix 8.4.2 of the Guidelines.

Summary of feedback  

Stakeholders generally supported the proposed additions. Some requested that other in silico models and test guidelines also be added.

Our response

The proposed amendment has been made and will commence on 24 April 2024. This means the Guidelines will be amended as shown in appendix 8.2 of the final draft of version 2 of the Guidelines [link].

AICIS will consider the other in silico models and test guidelines suggested by stakeholders, and these may be incorporated in future updates of the Guidelines.

Skin irritation

Proposal  

We proposed to amend part 6.20.2 of the Guidelines to specify that we will accept an in vivo study to show the absence of the skin irritation hazard characteristic, but the study must not show ‘Category 2’ skin reactions.

Summary of feedback  

Stakeholders generally supported these changes.

Our response

The proposed amendment has been made and will commence on 24 April 2024. This means the Guidelines will be amended as shown in part 6.20.2 of the final draft of version 2 of the Guidelines [link].

Skin sensitisation

Proposal  

We proposed to:

• add OECD guideline no. 497 as an acceptable test guideline to appendix 8.4.1 of the Guidelines
• amend part 6.14.2 of the Guidelines so that it is consistent with and better reflects the defined approaches in OECD guideline no. 497.

Summary of feedback on the proposal  

Stakeholders generally supported these changes.

Our response

The proposed amendment has been made and will commence on 24 April 2024. This means the Guidelines will be amended as shown in part 6.14 of the final draft of version 2 of the Guidelines.

Specific target organ toxicity after repeated exposure and bioaccumulation potential

Proposals  

We proposed to:

• remove one of the options for demonstrating that a high molecular weight polymer does not have the specific target organ toxicity after repeated exposure hazard characteristic that relies on the absence of the skin corrosion hazard characteristic. Add an option where the levels of low molecular weight species in the polymer can be used to prove the absence of this hazard.
• remove the options for demonstrating that a chemical does not have the bioaccumulation potential hazard characteristic that rely on the results of a ready biodegradability test (part 6.31.2 of the Guidelines).

Summary of feedback  

Some stakeholders were concerned about the impact of these changes on current introductions.

Our response

The proposed amendments will be made. However, to allow introducers to prepare for this change, commencement of these changes would be on 24 September 2024. This means the Guidelines will be amended as shown below, with changes coming into effect in September 2024.  

AICIS will contact introducers that we can identify as being affected by the amendments and guide them through the required changes.  

Sections to be changed

In part 6.16.2 the dot point:

• information that demonstrates that the chemical is a high molecular weight polymer that does not have the hazard characteristic, skin corrosion, or

will be changed to:

• information that demonstrates that the chemical is a high molecular weight polymer that has:  
  • < 5% by mass of molecules with molecular weight < 1000 g/mol, and  
  • < 2% by mass of molecules with molecular weight < 500 g/mol, or  

In part 6.31.2 the following dot points, including the footnote, will be deleted:

• if the chemical is not a highly branched organic ^{chemicalfootnote} – a test result from a study on the chemical or suitable read across information, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method:
  • tests based on dissolved organic carbon (DOC) - ≥ 70% DOC removal, or 
  • tests based on carbon dioxide generation - ≥ 60% theoretical carbon dioxide, or 
  • tests based on oxygen depletion - ≥ 60% theoretical oxygen demand, or
• a test result from a study on the chemical, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method: 
  • tests based on dissolved organic carbon (DOC) - ≥ 70% DOC removal, or
  • tests based on carbon dioxide generation - ≥ 60% theoretical carbon dioxide, or
  • tests based on oxygen depletion - ≥ 60% theoretical oxygen demand, or

Footnote: If the chemical is a highly branched organic chemical, in silico predictions and read across information cannot be used to demonstrate that the chemical does not have the bioaccumulation potential hazard characteristic – only studies on the chemical itself, as described in the next dot point, are acceptable.

Other changes to clarify information and requirements

Proposals  

We proposed to make several relatively minor changes to clarify information and requirements (refer to the minor amendments section of the Jan-Feb guidelines consultation).

Summary of feedback

Stakeholders were supportive of these changes.

Our response

The proposed amendments have been made and will commence on 24 April 2024. This means that the Guidelines will be amended as shown in various parts of the amendment history in endnote 2 of the final draft of version 2 of the Guidelines.

Attachment 1 – entries removed from the List as a result of removing information sources of the List

The following chemicals have been removed from the List as a result of the removal of information sources of the List, or due to them not aligning with the hazard characteristics in human health hazard band C. Note that some chemicals on the removed sources are not being entirely removed from the List, due to their presence on another list source. Also note that these chemicals may still be captured under their chemical group name by other information sources that make up our List, or under one of the categorisation steps as ‘medium to high risk’ introductions. 

Table 1. Japan’s CSCL Class II chemicals proposed to be removed from the List

Table 2. Canada’s Schedule 1 chemicals removed from the List

Table 3. EU SVHC 'equivalent level of concern' chemicals removed from the List

Table 4. EU SVHC respiratory sensitising chemicals removed from the List.

Table 5. IARC 'Group 3' chemicals removed from the List

Published: 26 March 2024