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From 24 April 2024 there will be changes to categorisation, reporting & record keeping requirements - see announcements on changes to the General Rules & changes to the Categorisation Guidelines.

Proposed changes to the List of chemicals with high hazards for categorisation

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This consultation is closed.

Background information

The ‚ÄėList of chemicals with high hazards for categorisation‚Äô (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 our highest hazard bands ‚Äď human health hazard band C and environment hazard band C or D.¬†

The list is a screening tool that introducers must use at steps 4-6 of the categorisation process when working out if their introduction can be categorised as exempted or reported. The introducer must check if their chemical is on the List and if it is, then the chemical has one or more of the hazard characteristics in the highest hazard bands. All esters and salts of chemicals on the List are currently considered to have the same high hazard characteristics as the chemical that is on the List. Introductions of chemicals on the List and with hazard characteristics in our highest hazard bands (such as carcinogenicity) could be categorised as assessed (medium to high risk), depending on the circumstances of the introduction.  

For many chemicals, data to allow the characterisation of hazards in the highest hazard bands for human health or environment may not be available. It may also be expensive and time-consuming to generate the studies. The List is a screening tool that:

  • helps introducers to categorise the introduction of their chemical based on known information and¬†
  • prevents chemicals that are known to be of high concern from being categorised as very low risk (exempted introductions) or low risk (reported introductions), depending on the circumstances of the introduction.¬†

The List is defined in Part 6 of the Industrial Chemicals Categorisation Guidelines (the Guidelines), with the sources of the chemicals on the List identified in Appendix 8.1 of the Guidelines. 

The List is presented as an Excel spreadsheet that introducers access on our website.

Changes to the Guidelines text

We propose additions to the definition text in Part 6 of the Guidelines to make it more clearly align with the purpose/function of the List and how it is accessed, in practice. Proposed additions are shown in bold below.
 

List of chemicals with high hazards for categorisation means a list of chemicals that have hazard characteristics in human health hazard band C or environment hazard bands D or C based on at least one of the information sources shown in Appendix 8.1 of these Guidelines. This list is part of Appendix 8.1 of these Guidelines and is published as an Excel spreadsheet on the AICIS website. It is used as a screening tool for categorisation.

We also propose changes to the text at the beginning of Appendix 8.1. Proposed additions are shown in bold below.

The list of chemicals with high hazards for categorisation is part of this appendix. It is published as an excel spreadsheet on the AICIS website. It consists of chemicals that are present on the following information sources: 

To improve clarity, we also propose to amend the wording in Appendix 8.1 around what substances have been included in the List, for all the sources. Instead of saying ‚ÄėIncluded substances are those classified for‚Ķ‚Äô, it will now state ‚ÄėSubstances included on the list of chemicals with high hazards for categorisation are those classified for‚Ķ‚Äô. ¬†For example, see below.

Example - changes for the source Safe Work Australia’s Hazardous Chemical Information System (HCIS) are shown in bold and strike-through: 

Safe Work Australia‚Äôs Hazardous Chemical Information System (HCIS) ‚ÄĒ list of substances classified for physical-chemical and (eco)toxicological hazards. Substances included substances on the list of chemicals with high hazards for categorisation are those classified for CMR and PBT.¬†

Adding chemicals to the List based on updates to current sources

In our last consultation, we noted that since originally publishing the List in 2020, the information sources have been updated to include more chemicals and that we would add these chemicals to the List. We are now providing the identities of the chemicals that will be added. 

View the additions to the List

There are nearly 600 unique entries that will be added to the List, as it has not been updated for approximately 4 years. Based on information provided to us in pre-introduction reports and post-introduction declarations, we will contact (or are already in contact with) the very few current introducers of the chemicals being added that could potentially be affected by this update.

Future updates to the List will be made yearly unless urgency dictates a shorter period, with a 3-month notice period given in advance of the update taking effect.  

Adding an information source

We propose to add the following information source to Appendix 8.1 of the Guidelines. Proposed additions are shown below.

European Commission Endocrine Disruptor List (https://edlists.org/) ‚Äď 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.

This list captures chemicals that have been identified as endocrine disruptors at the EU level, so it is appropriate that they are incorporated into the List of chemicals with high hazards for categorisation.

Removing certain chemicals from the List

Last year, we consulted on a proposal to remove: 

  • some information sources from the List, for example, Class II chemicals on the Chemical Substances Control Law of Japan
  • some entries from the List, for example, those that are neither a chemical element, a compound or complex of a chemical element nor, UVCB substance

We will proceed with the removal of these sources/entries and update Appendix 8.1 of the Guidelines accordingly. The full details of all entries that will be removed from the List will be published before the amended Guidelines commencement date. The details are not being published at this time, due to the negligible or very minor expected effect on current introducers, based on the type of entries being removed. Note that while some sources will be removed, in some instances a chemical would still be on the List based on other information sources, or the introductions of the chemicals would still be medium to high risk based on other categorisation steps.


Next steps in this proposal

High hazard esters and salts of chemicals on the List

As indicated above, all esters and salts of chemicals on the List are currently considered to have the same high hazard characteristics as the parent chemical that is on the List. Last year, we consulted on a proposal that responded to feedback from introducers that it is both time-consuming and difficult to go through the entire List and work out if their chemical is an ester or salt of any of the chemicals on the List. The proposal was 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 (i.e. if the chemical being introduced meets the exception criteria then it is not considered to have the hazard characteristic).

We have considered all the feedback we received on the general proposal and now seek your views about the identity of the chemicals that we would specify as requiring checking for esters and salts and the associated exceptions ‚Äď see table below.  

To be clear, if these changes proceed, there would not be any additional regulatory burden for introducers. Esters and salts of each of the chemicals in the table below are currently considered to have one or more of the hazard characteristics in human health hazard band C or environment hazard bands C or D. Steps 4 and 5 of the categorisation process would be easier for introducers of salts and esters ‚Äď to search the List, they would:  

  1. check, as they must do now, if their chemical is included on the List and  
  2. check if their chemical is an ester or salt of any of the chemicals identified below (instead of all chemicals on the List as is currently required) and if it is, whether or not an exception applies ‚Äď there are currently no exceptions. 
     

Table intro

The following table contains the subset of chemicals already on the List that we propose to specify in the Guidelines as requiring checking for salts and esters, along with the relevant hazard characteristics for each chemical, and any exceptions that would apply. 

An ester or salt of any of these chemicals would be considered to have the hazard characteristic (for example reproductive toxicity) unless it meets the exception criteria.

table

CAS no.Chemical nameHazard characteristics that 
apply to esters/salts
Exception criteria1
149-57-5Hexanoic acid, 2-ethyl  (2-EHA)Developmental toxicity

Salts: no exceptions

Esters: 1, 2 or 3

  1. The ester is a high molecular weight polymer, with low levels of low molecular weight species2
  2. The molecular weight of the chemical is greater than or equal to 500 g/mol
  3. Each product contains 5% or less, calculated as hexanoic acid, 2-ethyl-3
     
104-76-71-Hexanol, 2-ethyl- Developmental toxicity

Salts: no exceptions

Esters: 1, 2 or 3

  1. The ester is a high molecular weight polymer, with low levels of low molecular weight species2
  2. The molecular weight of the chemical is greater than or equal to 500 g/mol
  3. Each product contains 5% or less, calculated as 1-hexanol, 2-ethyl-

 

69-72-7Benzoic acid, 2-hydroxy-
(salicylic acid)
Developmental toxicity

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
     
110-80-5Ethanol, 2-ethoxy-Reproductive toxicity 
Developmental toxicity  

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
109-86-4Ethanol, 2-methoxy-Reproductive toxicity 
Developmental toxicity  

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
111-77-3Ethanol, 2-(2-methoxyethoxy)-Developmental toxicity

Salts and esters: 1, 2 or 3

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
  3. The concentration of the salt/ester at introduction and at all end uses is less than 3%
98-73-7Benzoic acid, 4-(1,1-dimethylethyl)- Reproductive toxicity

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
97-99-42-Furanmethanol, tetrahydro- (tetrahydro-2-furylmethanol) Reproductive toxicity
Developmental toxicity 

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
VariousBoric acidReproductive toxicity
Developmental toxicity

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
80-05-7Phenol, 4,4'-(1-methylethylidene)bis- (Bisphenol A)

Reproductive toxicity

Adverse effects mediated by an endocrine mode of action (human health and environment)

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
80-09-1Phenol, 4,4'-sulfonylbis- (Bisphenol S)

Reproductive toxicity

Adverse effects mediated by an endocrine mode of action (human health and environment)

Developmental toxicity

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
98-54-4    Phenol, 4-(1,1-dimethylethyl)-

Reproductive toxicity

Adverse effects mediated by an endocrine mode of action (environment)

Salts and esters: 1 or 2

  1. the salt/ester is a high molecular weight polymer that:
    a.    is not an ethoxylate polymer and
    b.    has low levels of low molecular weight species2
  2. the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
     
80-46-6Phenol, 4-(1,1-dimethylpropyl)-Adverse effects mediated by an endocrine mode of action (environment)

Salts and esters: 1 or 2

  1. the salt/ester is a high molecular weight polymer that:
    a.    is not an ethoxylate polymer and
    b.    has low levels of low molecular weight species2
  2. the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
VariousHeptylphenols on the List ‚Äď includes linear and branched isomers¬†Adverse effects mediated by an endocrine mode of action (environment)

Salts and esters: 1 or 2

  1. the salt/ester is a high molecular weight polymer that:
    a.    is not an ethoxylate polymer and
    b.    has low levels of low molecular weight species2
  2. the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
VariousOctylphenols on the List ‚Äď includes linear and branched isomers¬†Adverse effects mediated by an endocrine mode of action (environment)

Salts and esters: 1 or 2

  1. the salt/ester is a high molecular weight polymer that:
    a.    is not an ethoxylate polymer and
    b.    has low levels of low molecular weight species2
  2. the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
VariousNonylphenols on the List ‚Äď includes linear and branched isomers¬†Reproductive toxicity

Developmental toxicity

Adverse effects mediated by an endocrine mode of action (environment)
 

Salts and esters: 1 or 2

  1. the salt/ester is a high molecular weight polymer that:
    a.    is not an ethoxylate polymer and
    b.    has low levels of low molecular weight species2
  2. the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
VariousDodecylphenols on the List ‚Äď includes linear and branched isomersReproductive toxicity

Adverse effects mediated by an endocrine mode of action (health and environment)

Salts and esters: 1 or 2

  1. the salt/ester is a high molecular weight polymer that:
    a.    is not an ethoxylate polymer and
    b.    has low levels of low molecular weight species2
  2. the molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
VariousOctyl and Nonylphenol ethoxylates on the ListAdverse effects mediated by an endocrine mode of action (environment) Salts and esters: no exceptions
108-78-11,3,5-Triazine-2,4,6-triamine
(Melamine)
Carcinogenicity 

Salts: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 

Esters: not applicable

139-13-9Glycine, N,N-bis(carboxymethyl)- Carcinogenicity 

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
90-43-7[1,1’-Biphenyl]-2-olCarcinogenicity 

Genetic toxicity  

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
615-05-41,3-Benzenediamine, 4-methoxy- (diaminoanisole)Carcinogenicity 

Genetic toxicity  

Salts: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 

Esters: not applicable

123-30-8Phenol, 4-amino-Genetic toxicity

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
95-55-6Phenol, 2-amino-Genetic toxicity

Salts and esters: 1 or 2

  1. The salt/ester is a high molecular weight polymer, with low levels of low molecular weight species2 
  2. The molecular weight of the salt/ester is greater than or equal to 1,000 g/mol 
1 An ester or salt has one or more high hazard characteristics, unless one or more exception criteria are met 
2‚ÄėLow levels of low molecular weight species‚Äô means less than 10% (by mass) of molecules with a molecular weight that is less than 500 g/mol and less than 25% (by mass) of molecules with a molecular weight that is greater than 1,000 g/mol
3 Consistent with the entry in the Poisons Standard [Therapeutic Goods (Poisons Standard ‚Äď February 2023) Instrument 2023]

Example - ester and/or salt - introduction is outside boundaries (does not meet exceptions)

Example 1 ‚Äď chemical does not have high hazard characteristic

Corinne wants to introduce an ester of benzoic acid, 4-(1,1-dimethylethyl)- that has a molecular weight of 2,000 g/mol. She has reached step 4 in the categorisation process and must check the ‚ÄėList of chemicals with high hazards for categorisation‚Äô when working out if her chemical has any hazard characteristics in the highest human health hazard band (C).¬†

The ester itself is not on the List, but as her chemical is an ester of benzoic acid, 4-(1,1-dimethylethyl)-, she needs to consider whether an exception applies to her chemical. If an exception does not apply, the ester that she wants to introduce would be considered to have the same high hazard characteristics as benzoic acid, 4-(1,1-dimethylethyl)-. 

Because Corinne‚Äôs chemical has a molecular weight ‚Č•1,000 g/mol, it meets the exception criteria (exception 2 in this case). Corinne‚Äôs ester is not considered to have the hazard characteristics. Corinne continues through step 4 of the categorisation process.

Example - introduction is within boundaries (meets exceptions)

Example 2 ‚Äď chemical does not have high hazard characteristic

Joe wants to introduce an ester of hexanoic acid, 2-ethyl-. He has reached step 4 in the categorisation process and must check the ‚ÄėList of chemicals with high hazards for categorisation‚Äô when working out if his chemical has any hazard characteristics in the highest human health hazard band (C).¬†

The ester itself is not on the List, but as his chemical is an ester of hexanoic acid, 2-ethyl-, he needs to consider whether an exception applies to his chemical. If an exception does not apply, the ester that he wants to introduce would be considered to have the same high hazard characteristics as hexanoic acid, 2-ethyl-. 

The molecular weight of Joe’s ester is 450 g/mol which does not satisfy the molecular weight exception criterion (exception 2 in this case). The maximum concentration of the ester at introduction and all end uses is 9%. Assuming complete hydrolysis of the ester to release the acid, Joe calculates the concentration as hexanoic acid, 2-ethyl- is 3%. Therefore, it meets the concentration exception criteria (exception 3 in this case). Joe’s ester is not considered to have the hazard characteristics. Joe continues through step 4 of the categorisation process. band C. 
 

Example 3 ‚Äď most introductions¬†

Reagan wants to introduce a salt of a chemical other than one proposed in the table above. ¬†They have reached step 4 in the categorisation process and must check the ‚ÄėList of chemicals with high hazards for categorisation‚Äô when working out if their chemical has any hazard characteristics in the highest human health hazard band (C).¬†

The salt itself is not on the List, and because their chemical is a salt of a chemical other than one included in the table above, Reagan’s check of the List no longer needs to consider the salts of all chemicals on the List, and so their check of the List is complete. 

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