AICIS Industrial Chemicals (General) Rules 2019

AICIS logo - new scheme starting on 1 July 2020 that replaces NICNAS

The Industrial Chemicals (General) Rules 2019 (General Rules) are now final. They set out the details for the regulation of the importation and manufacture of industrial chemicals in Australia under the new scheme.

View the General Rules

Key changes in the final General Rules

On this page we give you a snapshot of the main changes we've made since we published the draft General Rules for consultation.

This page contains a lot of information, so we've grouped some topics to reduce the need for a lot of scrolling:

Categorisation topics — key changes

Skip to next section (use of animal test data)


Introductions that cannot be exempted or reported (section 25)

These types of introductions cannot be exempted or reported.  The following is a full list as specified in the Rules:

  • chemicals listed on the Rotterdam or Stockholm Conventions:
    • where no action has yet been taken to restrict the chemicals in Australia
  • a chemical listed on the Inventory with conditions 
    • and you intend to introduce outside the conditions
  • the AICIS Executive Director has requested information about an introduction 
    • and the information requested has not been provided

Introductions that are exempted (section 26)

We’ve made the following changes:

  • increased the volume threshold for chemicals that are introduced solely for use in research and development, and are not at the nanoscale to 250 kg (from the previous threshold of 100 kg), and
  • added a scenario for introduction of industrial chemicals resulting from non-functionalised surface treatment of listed industrial chemicals.

Introductions that are reported (section 27)

We’ve added these scenarios:

New scenario: Chemicals introduced for research and development only

Applies where the:

  • chemical is not at the nanoscale
  • chemical’s use is subject to the introducer’s control
  • chemical meets other criteria
  • chemical’s introduction volumes are greater than 250 kg

New scenario: Low-risk flavour or fragrance blend introductions

To ensure that these introductions can be considered low risk, they must meet certain criteria, including concentration and hazard criteria. This scenario covers the fairly common situation where an introducer doesn’t know all the ingredients in the fragrance or flavour blend. Rather than expecting an introducer to know all the ingredients in the fragrance or flavour blend, either:

  • the chemical can be on the public International Fragrance Association (IFRA) Transparency List when the pre-introduction report is submitted, or
  • information about the chemical identity, its hazard characteristics, concentration at introduction and end use, and names of the flavour or fragrance blends can be given to the Executive Director (eg by the fragrance supplier) before the introduction occurs.

Note we’ve changed this scenario following stakeholder feedback. We received this feedback in our most recent consultation on the General Rules (April 2019). This consultation arose after the passage of the Industrial Chemicals Act.


Determining indicative human health risk for an introduction (section 28)

Introductions that will always be medium to high indicative risk for human health

You don’t have to consider the detailed exposure and hazard band criteria for:

  • introductions of certain chemicals at the nanoscale that:
    • are not soluble, and
    • are not incidental to the introduction of the non-nanoscale portion of the industrial chemical
  • introductions of industrial chemicals that:
    • have a sequence of greater than or equal to 4
    • but no more than 20, fully fluorinated carbon atoms
  • introductions of polyhalogenated organic chemicals that:
    • are persistent, or have environmental degradation products known to be persistent
    • where the industrial chemical is introduced in volumes greater than 100 kg/year.

Industrial chemicals that are internationally-assessed for human health and meet additional criteria

These can be low indicative human health risk and you don’t have to consider the detailed exposure and hazard band criteria.

They could be very low indicative human health risk if further consideration is given to exposure and hazard band criteria.

Introductions that will have an indicative human health risk that is at least low risk

They can’t be very low risk, but could be low risk or medium to high risk:

  • introduction of UV filters, and
  • introduction of certain chemicals at the nanoscale that:
    • are not soluble, and
    • are incidental to the introduction of the non-nanoscale portion of the industrial chemical

Determining indicative environment risk for an introduction (section 29)

Introductions that will always be medium to high indicative risk for environment

You don’t have to consider the detailed exposure and hazard band criteria for:

  • introductions of certain chemicals at the nanoscale that
    • are not soluble, and
    • are not incidental to the introduction of the non-nanoscale portion of the industrial chemical
  • introductions of industrial chemicals that:
    • have a sequence of greater than or equal to 4
    • but no more than 20, fully fluorinated carbon atoms
  • introductions of polyhalogenated organic chemicals that:
    • are persistent or have environmental degradation products that are known to be persistent
    • where the industrial chemical is introduced in volumes greater than 100 kg/year
  • introductions of persistent gases where the volume introduced in a year is more than 100 kg, and
  • introductions of organotin chemicals where the volume introduced in a year is more than 10 kg.

Industrial chemicals that are internationally-assessed for environment and meet additional criteria

These can be can be low indicative environment risk and you don't have to consider the detailed exposure and hazard band criteria.

They could be very low indicative environment risk if further consideration is given to exposure and hazard band criteria.

These introductions will have an indicative environment risk that is at least low risk. They can’t be very low risk, but could be low risk or medium to high risk Introduction of:

  • organotin chemicals
  • polyhalogenated organic chemicals
  • industrial chemicals for an end use as a biocidal active, and
  • certain chemicals at the nanoscale that are:
    • not soluble and
    • incidental to the introduction of the non-nanoscale portion of the industrial chemical.

Human health exposure band (Schedule 1, Part 1)

The determination of the human health exposure band for an introduction can depend on the following parameters:

  • the human health categorisation volume for the industrial chemical
  • the concentration of the industrial chemical at introduction
  • the concentration of the industrial chemical at end use
  • whether the introduction will involve exposures from end use in tattoo inks or personal vaporisers, and
  • whether the introduction of the industrial chemical involves any consumer end uses.

We’ve made other changes to human health exposure band criteria:

  • added a lowest exposure band (now exposure band 1). This allows for different indicative risk outcomes for chemicals:
    • used at very low concentrations
    • that have no consumer exposure in their end use
  • increased the volume threshold for 1 of the scenarios in what is now exposure band 2 from 10 kg to 25kg or 250 kg (depending on the end uses)
  • removed the exposure band scenario for introductions with end uses in cosmetics that required both very low volume and very low concentration
  • these introductions will now always be in the highest exposure band:
    • end use is in tattoo inks or
    • end use is in personal vaporisers.

Human health hazard band (Schedule 1, Part 1)

We’ve made these changes:

  • reordering of items in the hazard band table to allow a more logical presentation in the Categorisation Guidelines
  • changed descriptions of certain hazard characteristics
  • condensed mutagenicity and genotoxicity to the single characteristic, genetic toxicity
  • removed certain hazard band criteria relating to high molecular weight polymers. This is because the waivers in the Categorisation Guidelines will deal with high molecular weight polymers with other characteristics.

Environment exposure band (Schedule 1, Part 2)

We’ve increased environment categorisation volume in exposure band 1 to 25 kg.


Environment hazard band (Schedule 1, Part 2)

We’ve made these changes:

  • reordered items in the hazard band table to allow a more logical presentation in the Categorisation Guidelines
  • changed descriptions of certain hazard characteristics.

Information required to demonstrate categorisation (section 30)

We’ve made several changes to this section. It’s more specific now about the type of information you need.


Use of new animal test data (sections 8, 19-22, 31-34)

The Rules restrict the use of new animal test data for applications and for categorisation purposes if a chemical has any of these end uses:

  • end use solely in cosmetics, and
  • multiple end uses, with one of those end uses being in cosmetics, and one or more end uses being non-cosmetic.

There are exceptions to these restrictions

There are exceptions to these restrictions for particular types of new animal test data, which are necessary to continue to protect human health and the environment, and to align as far as possible with comparable international restrictions on animal test data.

The exceptions are where new animal test data:

  1. Demonstrates that the chemical has a hazard characteristic. The details of this exception differ and depend on whether the data is for application or categorisation purposes. Refer to the Rules for details.
  2. Is the only information that can demonstrate whether or not the chemical has a particular environment hazard characteristic. This exception applies if there are no validated alternative tests to determine this characteristic other than animal tests.
  3. Where tests have been done on a different, but related chemical (ie not the chemical you’re introducing). This exception only applies if you’re not introducing the other (related) chemical for an end use in cosmetics.

Where a chemical introduction has multiple end uses (including an end use in cosmetics)

Here, an introducer will have to apply to the Executive Director to approve the use of certain animal test data. An introducer will need this approval for applications or for categorisation purposes.

The reason for this exception is to take into account any human health or environment exposure that may arise from the non-cosmetic end uses of the introduction.


Compliance topics — key changes

Skip to the next section - other topics


Post-introduction declarations for exempted introductions (sections 36, 37)

Exempted declarations are required for introductions:

  • of PLCs (polymers of low concern)
  • of low concern biological polymers, and
  • where the highest indicative risk is very low risk.

The information you need for a declaration varies. It depends on the type of exempted introduction. In some cases, it also depends on the volume introduced during the registration year.

You do not have to submit an exempted declaration for industrial chemicals that are:

  • imported and subsequently exported
  • solely for use in research and development
  • polymers that are comparable to listed polymers
  • comparable to listed industrial chemicals, and
  • chemicals that result from non-functionalised surface treatment of listed industrial chemicals.

We've published more content on exempted declarations


Pre-introduction reports for reported introductions (sections 38-43)

We’ve made changes to sections of the Rules that set out reporting requirements for reported introductions.

Some changes we’ve made include:

  • restructuring the sections – now all reporting requirements for a particular type of reported introduction are together
  • allowing for the chemical identity of the industrial chemical to be provided to the Executive Director by the chemical identity holder if the introducer doesn’t know it.

Record keeping (Chapter 4)

We’ve made changes to the sections of the Rules that set out the record keeping requirements.

We’ve made these changes:

  • you can now use the INCI name for the industrial chemical as a record of the chemical name, as long as it has an assigned CAS number (for certain types of introductions)
  • expanding the circumstances in which written undertakings from a chemical identity holder can be kept as records instead of:
    • specific information about the chemical identity of an industrial chemical, or
    • information that relies on the chemical identity of the chemical being known.
  • your written undertaking must specify that you’ll give the Executive Director the necessary records if requested.

Other topics — key changes


Internationally-assessed chemicals (sections 6, 28, 29)

We’ve made the following changes:

  • criteria for internationally-assessed industrial chemicals (rather than introductions). Industrial chemicals that are internationally-assessed for human health or the environment must meet additional criteria in order to be of low indicative risk for human health or the environment
  • changes to the trusted international bodies and type of assessments:
    • addition of opinions from the European Food Safety Authority (EFSA) on materials and articles intended to come into contact with food
    • removal of risk assessments done by applicants for authorisation under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
    • amendments to the description of  Scientific Committee on Consumer Safety (SCCS) opinions
    • addition of risk assessments for the approval of biocidal active substances in Europe.

Commercial evaluation authorisations (section 18)

Some changes to the circumstances in which an industrial chemical that is eligible for a CEA cannot be made available to the general public as part of an article.


Specified classes of introduction (section 7)

We’ve:

  • added introductions of an industrial chemical for an end use in an article that is a children’s toy or a children’s care product, and
  • removed introductions of monohalogenated organic chemicals.

Definitions in the General Rules (section 5)

We’ve clarified wording and terminology used in certain definitions.

We’ve also defined some further terms.

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Last update 3 December 2019