Step 2: Introductions that are categorised as exempted

2.1 Australian-made soap using lye and maximum of 100 kg of fat/oil a year

For the purposes of this guide, ‘soap-chemical’ refers to the chemical that is made by mixing lye (sodium hydroxide or potassium hydroxide) with an oil or fat. 

2.1.1 Is your soap-chemical made (manufactured) in Australia?

If yes, go to 2.1.2.

If no, go to 2.2 or skip to Step 3 if your introduction is not covered elsewhere on this page.

2.1.2 Is your soap-chemical made using a saponification process with a fat or oil and lye (either aqueous sodium hydroxide or aqueous potassium hydroxide)?

If yes, go to 2.1.3.

If no, go to 2.2 or skip to Step 3 if your introduction is not covered elsewhere on this page.

2.1.3    Is the total volume of the fat or oil used to make the soap-chemical no more than 100 kg in an AICIS registration year (1 September to 31 August)?

If yes, then your introduction is in the exempted category for introduction of manufactured soap. Skip to Your obligations after categorisation.

If no, go to 2.2 or skip to Step 3 if your introduction is not covered elsewhere on this page.

Example 1

Alita makes soap in Australia using aqueous sodium hydroxide and 100 kg of coconut oil per AICIS registration year (1 September to 31 August).

Introduction of Alita's soap-chemical can be categorised as exempted as all criteria are met.

Example 2

Darren makes soap in Australia using aqueous sodium hydroxide, 50 kg of cottonseed oil and 80 kg of linseed oil per AICIS registration year (1 September to 31 August).

Introductions of Darren's soap-chemicals can be categorised as exempted as all criteria are met.

2.2 Chemicals that are imported and subsequently exported

Your introduction is categorised as exempted if all of the following apply:

• the entire volume is imported and subsequently exported out of Australia
• the packaging in which your chemical is immediately contained is never opened
• whilst your chemical is in Australia, it remains under the control of either customs (for longer than 25 working days) or the introducer.

Note: if your chemical is under customs controls whilst in Australia and leaves Australia within 25 days, then your introduction is an excluded introduction.

2.3 Chemicals that are only used for research and development

Your introduction is categorised as exempted if all of the following apply (note that the volume of chemical that you can introduce in a registration year is lower, unless you can demonstrate that the nanoscale criteria do not apply to your introduction):

• you only use your chemical for research and development, or you make it available to another person who only uses it for research and development
• you don’t make your chemical available to the public on its own, in combination with other industrial chemicals or as part of an article
• you use control measures to eliminate or minimise any risks to the environment and any risks to the people involved in using the chemical for research and development

and point 1 or 2 or 3 applies:

1. You will introduce up to 250 kg of your chemical in a registration year and you can demonstrate that all quantities of your chemical are not introduced as a solid or in a dispersion. To prove that your chemical is not introduced as a solid or in a dispersion, you might have an SDS or product information sheet that indicates the appearance (for example, in liquid form).
2. You will introduce up to 250 kg of your chemical in a registration year and you can demonstrate that all quantities of your chemical do not consist of solid particles in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the particle size range of 1 to 100 nm. To prove that your chemical does not consist of solid particles in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale, you might have a study report about the particle size distribution of your chemical.
3. You will introduce up to 10 kg of your chemical in a registration year.

Learn more about categorising chemicals introduced for research and development

2.4 Polymers of low concern (PLC)

Your introduction is categorised as exempted if it meets the criteria for a polymer of low concern and it’s not a high molecular weight polymer that has lung overloading potential.

Learn about PLC criteria

If you are introducing polymers of low concern, you must submit a once-off exempted introduction declaration by 30 November (following the end of our registration year).

2.5 Low-concern biological polymers

Your introduction is categorised as exempted if it’s a low-concern biological polymer that meets all of the following criteria:

• the chemical is a biological chemical (that is, it’s derived from a living or once-living organism, without further modification, or produced by a living or once-living organism, without further modification)
• the chemical is a polymer
• the polymer meets most of the polymer of low concern criteria, except that it’s not stable, meaning that it substantially degrades, decomposes or depolymerises during use into simpler, smaller weight chemicals

Examples of low-concern biological polymers are keratin and collagen. Enzymes are not polymers because of the lack of variability in molecular weight.

If you are introducing low-concern biological polymers, you must submit a once-off exempted introduction declaration by 30 November (following the end of our registration year).

2.6 Polymers that are comparable to listed polymers

Your introduction is categorised as exempted if ALL of the following apply:

• your chemical is a polymer
• your polymer contains exactly the same reactants (must have each of the reactants) as another polymer that is already listed on the Inventory
• your polymer contains one or more other reactants (the additional reactants) that the listed polymer does not
• each additional reactant is present at no more than 2% by weight of the polymer

You must also comply with any regulatory requirements associated with the listed polymer.

Example 1

Sean plans to introduce a polymer manufactured from reactants A, B and C (Polymer ABC), which is not on the Inventory.

He knows that reactant C is present at no more than 2% by weight of the polymer. He searches the Inventory for the comparable polymer, Polymer AB, and finds that it is listed on the Inventory. This means Sean can introduce Polymer ABC as an exempted introduction if he's registered with us and his introduction meets any regulatory obligations for the listed polymer, Polymer AB.

Later, Sean decides he wants to introduce Polymer ABC with reactant C present at greater than 2% by weight of the polymer. This would mean it is no longer comparable to the listed polymer, Polymer AB. Sean must re-categorise his introduction.

Example 2

Kate plans to introduce a polymer manufactured from reactants W, X, Y and Z (Polymer WXYZ), which is not on the Inventory. She knows that reactants Y and Z are each present at no more than 2% by weight of the polymer.

She searches the Inventory for the comparable polymers (i.e., Polymer WX, Polymer WXY or Polymer WXZ) and finds that Polymer WXY is listed on the Inventory.

This means Kate can introduce Polymer WXYZ as an exempted introduction if she's registered with us and her introduction meets any regulatory obligations for the listed polymer, Polymer WXY.

Later, Kate plans to introduce Polymer WXYZ with reactant Z present at greater than 2% by weight of the polymer.  This would mean it is no longer comparable to the listed polymer, Polymer WXY. Kate must re-categorise her introduction.

Determining percent by weight

The ‘percent by weight’ of each reactant may be determined by the percent charged to the reactor, or the percent incorporated in the polymer as established analytically. When using the percent incorporated method, the percent by weight of the reactant is based on the minimum weight of reactant to account for the actual weight of the reactant or fragments of the reactant incorporated in the polymer.

Example 1 – percent incorporated method

Kamal manufactures his polymer using the radical initiator azobis[isobutyronitrile] (AIBN, MW = 164 g/mol), charged into the reactor at 3%. This class of initiator is known to produce radicals that contain the nitrile moiety (CN, MW = 26 g/mol). Kamal analyses the polymer and finds that it contains 0.39% by weight nitrile, which originates only from AIBN. This 0.39 g of nitrile fragment in 100 g of polymer corresponds to 0.015 moles of nitrile fragment (0.39 g / 26 g/mol = 0.015 moles) in 100 g of polymer. As 1 mole of AIBN reactant produces 2 moles of nitrile fragment, the amount of AIBN reactant to account for the actual amount of nitrile fragment incorporated in the polymer is 0.015/2 = 0.0075 moles AIBN in 100 g of polymer, or 1.23 g (0.0075 mol x 164 g/mol) AIBN in 100 g of polymer. This corresponds to a weight percent of AIBN reactant incorporated of 1.23%. 

Example 2 – percent incorporated method

Sienna manufactures a polymer containing free carboxylic acid groups which is neutralised using a large excess of sodium hydroxide (NaOH, MW = 40 g/mol). The total amount of base charged to the reactor is 10%. Sienna analyses the resulting polymer salt and find that it contains 1.52% by weight of sodium (atomic weight = 23 g/mol), which originates only from the base. This 1.52 g of sodium in
100 g of polymer corresponds to 0.066 moles (1.52 g / 23 g/mol) of sodium in 100 g of polymer. The amount of NaOH reactant to account for the actual amount of sodium incorporated in the polymer is 0.066 moles NaOH in 100 g of polymer, or 2.64 g (0.066 mol x 40 g/mol) NaOH in 100 g of polymer. This corresponds to a weight percent of NaOH reactant incorporated of 2.64%.

2.7 Chemicals that are comparable to listed chemicals

If you’re introducing any of the chemicals in column B of the table below, your introduction could be categorised as exempted.

If your chemical is in the comparable chemicals table

If your chemical is in column B of the table, it means that it has a comparable chemical that is already listed on the Inventory. Go to column C of the same row to find it. Next, search for the comparable chemical on the Inventory using the CAS number in column C to check whether there are any regulatory requirements or obligations for the listed chemical.

If your search results show:

• there are no regulatory requirements for the chemical, your introduction is categorised as exempted 
• there are regulatory requirements for the chemical and you can meet these requirements, your introduction is categorised as exempted 
• there are regulatory requirements for the chemical, but you cannot meet these requirements and none of the other introductions described on this page apply to you, move onto step 3: Introductions that are categorised as reported.

If your chemical is not in the comparable chemicals table

If your chemical is not in the table below and none of the other introductions described on this page apply to you, move on to step 3: Introductions that are categorised as reported.

Examples

Your proposed introduction: 
You plan to introduce ‘fatty acids, palm-oil, sodium salts’ (CAS No. 61790‑79‑2), which is not on the Inventory, but is in column B of the comparable chemicals table. In column C of the same row you find ‘fatty acids, C14‑18 and C16‑18‑unsaturated, sodium salts’ (CAS No. 67701‑11‑5), which means this chemical is comparable to your chemical and listed on the Inventory. You search this chemical (CAS No. 67701‑11‑5) on the Inventory and find there are no regulatory requirements associated with the introduction of this chemical. This means you can introduce your chemical (CAS No. 61790‑79‑2) as an exempted introduction if you're registered with us.

Your proposed introduction:
You plan to introduce 'soya phospholipids' (CAS No.308069‑41‑2) in end use products at a concentration level of 30%. Soya phospholipids is in column B of the comparable chemicals table. In column C of the same row, you find 'phospholipids' (CAS No. 123465‑35‑0) which means this chemical is comparable to your chemical and listed on the Inventory. You search this chemical (CAS No. 123465‑35‑0) on the Inventory and find there are regulatory conditions under the term ‘defined scope of assessment'. It says 'This chemical has been assessed as a component of dermal cosmetic products at concentrations no more than 20%. This chemical is not to be used in topical products intended for the eye'.

You don't meet this condition because you plan to use your chemical – soya phospholipids – at a concentration of 30% in end use products. This means your introduction is not categorised as exempted. If none of the other introductions described on this page apply to you, go to step 3: Introductions that are categorised as reported.

2.8 Chemicals resulting from non-functionalised surface treatment of listed chemicals

Your chemical introduction is categorised as exempted if the chemical is a non-functionalised surface-treated chemical resulting from a reaction of chemicals that are all listed on the Inventory. To be an exempted introduction, your chemical must meet all of the following criteria:

• it is the result of a reaction between 2 or more chemicals, all of which are listed on the Inventory
• the reaction to produce the chemical occurs at the surface of one of the chemicals (the substrate chemical) and the substrate chemical is listed on the Inventory
• it does not have any reactive functional groups that were not already on the substrate chemical before the reaction occurred
• it is not introduced as a solid or in a dispersion that consist of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the particle size range of 1 to 100 nm.

Step 2 outcome

My introduction meets the criteria on this page.

This means that your introduction is in the 'exempted' category. 

Skip to Your obligations after categorisation to learn about your reporting and record-keeping obligations.

My introduction does not meet criteria on this page

If your introduction is not covered on this page, go to step 3.

Next – Step 3: Introductions that are categorised as reported