Excluded (non-industrial) use chemicals on AICS
IMAP Tranche 24
Tranche 24 assessments were published on 29 June 2018 and are open for public comment until 24 August 2018.
As part of this work, we've updated our excluded use chemicals list. You can read more about our approach to identifying them and how we define them.
To see what has been added, read our lists of excluded use chemicals [Excel 139KB].
Submit your comments here
Our work to date
In Stage 2 of IMAP, we are screening the Australian Inventory of Chemical Substances (the Inventory) for chemicals that are only used, or suspected of only being used, in applications that are not “industrial”. That is, they only have 'excluded uses' under the ICNA Act. These excluded uses include therapeutic, agricultural, veterinary or food use.
Learn more about excluded use chemicals
Chemicals used in these ways are not considered to be industrial chemicals (even if they are listed on the Inventory) and do not need Tier II IMAP assessment.
This work will help identify higher risk industrial chemicals that we need to assess. We use a range of sources to help us decide which chemicals are likely to only have excluded uses, including legislative sources, consultations with relevant Australian Government agencies, general information searches and public consultation on assessments.
Relevant legislation that these chemicals are also subject to:
Therapeutic Goods Act and the Agricultural and Veterinary Chemicals Code Act
Excluded uses of chemicals include those uses subject to the Therapeutic Goods Act 1989 (TG Act) and the Agricultural and Veterinary Chemicals Code Act 1994. If a chemical has an industrial use in addition to any excluded use(s), it is considered to be an industrial chemical.
We have identified lists of excluded use chemicals [Excel 139KB] (on the Inventory) that are also listed in schedules to the Poisons Standard (Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP) made under the TG Act in:
- Schedule 4 (Prescription Only Medicine, or Prescription Animal Remedy) without specific use conditions or use exemptions
- Schedule 4 with specific exemptions, including entries in other schedules of the SUSMP, which are highly restrictive and preclude industrial use
- Schedule 8 (Controlled Drug)
- Schedule 9 (Prohibited Substance)
Download excluded chemicals list [Excel 139KB]
The salts and derivatives of the chemicals listed in the above Schedules are also included as excluded use chemicals (See Part 1 (2) (c) of the Poisons Standard).
Most of these chemicals have been considered by us in IMAP Tranches 20 and 21 as Tier I (human health and environment).
Go to Tier I human health assessments
Go to Tier I environment assessments [Excel 100KB]
Chemicals in Schedules 4, 8 and 9 of the Poisons Standard
These Schedules include important restrictions on the supply of the chemicals. Schedules 4 and 8 are for prescription medicines, while Schedule 9 is for prohibited substances. They are described in the Poisons Standard as:
- Schedule 4 — Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.
- Schedule 8 — Controlled Drug – Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.
- Schedule 9 — Prohibited Substance – Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.
The Poisons Standard further states:
- "The SUSMP contains the decisions of the Secretary of the Department of Health or the Secretary's delegates regarding the classification of poisons into Schedules, as recommendations to Australian States and Territories. The scheduling classification sets the level of control on the availability of poisons. The scheduling of poisons is implemented through relevant State and Territory legislation."
- "Poisons which are packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in the SUSMP as they are covered by labelling requirements under applicable jurisdictional Work Health and Safety laws, as amended from time to time. Note, however that this exemption does not extend to controls on supply of these poisons."
Chemicals listed in any of these Schedules without qualifications cannot be used for industrial purposes in Australia. Many of the chemicals listed on these schedules with qualifications have exclusions from the relevant schedule only under narrowly defined conditions that do not include industrial use. Thus, they cannot be supplied for industrial purposes. Please let us know if you are aware of any of these chemicals being used in Australia for industrial purposes.
Probable 'excluded use' chemicals
Agricultural and veterinary chemicals
Another large group of chemicals placed on the Inventory but did not have any industrial uses, were pesticide compounds. For example, dichlorodiphenyltrichloroethane (DDT) and dieldrin are listed on the Inventory. Most of these chemicals are not prohibited from industrial use but we believe that they have never had an industrial use.
We have consulted with the Australian Pesticides and Veterinary Medicines Authority (APVMA) to identify chemicals which may be used, or may have been used, in pesticides and veterinary medicines but have not been used industrially. There are no absolute restrictions preventing industrial use of these chemicals. Therefore, there is a possibility that industrial uses may exist. If you are aware of any such industrial use, please let us know.
Download Probable agricultural and veterinary excluded use chemicals [Excel 139KB]
Approved therapeutics in other Schedules of the SUSMP
Apart from chemicals approved for therapeutic use in Schedules 4 and 8 of the SUSMP, there are therapeutics included in Schedules 2 and 3 (which are less restrictive). While these Schedules do not prohibit their supply for non-therapeutic uses, it is unlikely that they would have industrial uses (for example, paracetamol). Instead, it is likely that listing of these chemicals when the Inventory was created (it was originally created as a list of chemicals, not just industrial chemicals, used in Australia) was not as a result of any known industrial use. If you are aware of any industrial use of these chemicals, please let us know.
Download Probable excluded use therapeutic chemicals [Excel 139KB]
Therapeutics not approved for use in Australia
There are chemicals listed on the Inventory with known therapeutic use internationally, but which have never been approved for therapeutic use in Australia. The listing of these chemicals on the Inventory and their lack of approval for therapeutic use in Australia could suggest they have industrial uses in Australia. However, this is considered unlikely based on their chemical identification and their known biological activities. Alternatively, these chemicals may have had historical uses in biomedical research that led to their introducers proposing them for inclusion on the Inventory. If you are aware of any current or likely future industrial use, please let us know.
Download Probable excluded use therapeutic chemicals [Excel 139KB]
Remaining excluded use chemicals on the Inventory
In Tranche 24, we have included additional chemicals listed on the Inventory but suspected of having excluded uses. These include chemicals suspected of having therapeutic use, but not listed as constituents of therapeutic goods in Australia. We have also included chemicals not captured previously, that are suspected of being used solely in agricultural or veterinary medicine applications.
Outcomes of previous tranches
In Tranche 22, we included chemicals known to have agricultural and/or veterinary use that are not prohibited by scheduling and are listed on the Inventory. We received feedback that helped us to better characterise some of these chemicals and confirm whether they have an industrial use. This information has also been useful to help us decide if we need to do any further assessment of the chemicals for the risks associated with their industrial use. We consider such feedback very helpful.
Last update 11 July 2018