Categorisation of chemicals in cosmetics

Who should read this?

Importers and manufacturers ('introducers') of industrial chemicals (and products that contain industrial chemicals) that are for use in cosmetics. This guidance will help you work out whether your introduction will be an exempted, reported or assessed introduction. You must read this in conjunction with our Guide to categorising your chemical introduction.

What is a cosmetic?

See our definition of a cosmetic or use our decision tool.

Is your introduction exempted, reported or assessed?

You must work out if your introduction meets the criteria for the exempted or reported categories by going through steps 0-6 of our Guide to categorising your chemical introduction. If your introduction does not meet the criteria for the exempted or reported categories, it will be an assessed introduction.

Note, as chemicals in cosmetics are available to the general public, you cannot apply for a commercial evaluation authorisation for the introduction of your chemical.

Notes:

You need to know if your introduction is a specified class of introduction. There may be additional or different requirements when working out your category of introduction as well as additional record keeping obligations.

If you're introducing a chemical in a flavour or fragrance blend, you may meet our criteria for an introduction that's categorised as reported.

Step 2: Introductions that are categorised as exempted and Step 3: Introductions that are categorised as reported in our Categorisation Guide will allow you to work out if your introduction can be exempted or reported and quickly get your answer. Otherwise, if you don't meet criteria at either of these steps, you need to continue with steps 4-6 of the Categorisation Guide. Your introduction may still be exempted or reported if it can meet criteria after your work through these extra steps.

What is the human health exposure band?

If your chemical will also have an end use in tattoo inks, then your introduction involves a 'designated kind of human exposure' and the human health exposure band for your introduction is 4.

See Categorisation of chemicals in tattoo inks for further information.

Otherwise, the human health exposure band for your introduction could be 2, 3 or 4, depending on the human health categorisation volume (HHCV) for your chemical and/or its concentration at introduction and end use.

If your chemical will only have end uses in cosmetics, the HHCV for your introduction will be the same as the total volume of your chemical that you will introduce in a registration year.

If your chemical will have other end uses, you can work out your HHCV to see which human health exposure band applies to your introduction. If you do this, the HHCV for your introduction may be less than (or equal to) the total volume of your chemical that you will introduce in a registration year.

The human health exposure band is 2 if the:

• HHCV for your introduction is less than or equal to 25 kg or
• concentration of your chemical at introduction AND at all end uses will be less than 0.1%.

The human health exposure band is 3 if the:

• HHCV for your introduction is less than or equal to100 kg or
• concentration of your chemical at introduction AND at all end uses will be less than or equal to 1%.

The human health exposure band is 4 if the scenarios described for exposure bands 2 and 3 do not apply to your introduction.

Information you need to show that your chemical does not have human health hazard characteristics

Read Step 4.4 of the Guide to categorising your chemical introduction

Use of animal test data for chemicals in cosmetics

We do not require you to have data to demonstrate the absence of hazard characteristics for many introductions (for example, PLCs and those that fall into lower environment exposure bands). The circumstances where we do require information to demonstrate the absence of hazard characteristics to categorise your introduction are outlined in the Industrial Chemicals Categorisation Guidelines. For each hazard characteristic we provide details of all acceptable alternatives that you can use instead of animal test data.

Note: If your introduction is a 'specified class of introduction' (for example, introductions of UV filters), you may need additional or different information to show your chemical doesn’t have particular human health hazard characteristics.

What is the environment exposure band?

The environment exposure band for your introduction could be 1, 2, 3 or 4.

Release into the environment from end use in cosmetics is not a “designated kind of release into the environment”. Introductions of chemicals used in cosmetics are not ‘intentionally released to the environment during use’. These chemicals are disposed to landfill or wastewater after end use. Wastewater is then treated at sewage treatment plants, which typically removes a large portion of the chemical before release of the treated water to the environment. However, you need to consider if this definition is met for any other uses that your chemical has. If the introduction of your chemical involves a designated kind of release into the environment, the environment exposure band is 4.

Otherwise, the environment exposure band for your introduction could be 1, 2, 3 or 4, depending on the environment categorisation volume (ECV) for your chemical.

The ECV for your introduction will be the same as the total volume of your chemical that you will introduce in a registration year, unless you choose to work out a lower ECV due to your chemical having:

• an end use in products meeting our definition of 'Personal care products - limited environmental release' (for example, nail polish)
• other end uses in addition to cosmetics

The environment exposure band for your introduction is:

• 1 if the ECV for your introduction is less than or equal to 25 kg
• 2 if the ECV is greater than 25 kg and less than or equal to 1,000 kg
• 3 if the ECV is greater than 1,000 kg and less than or equal to 10,000 kg
• 4 if the ECV is greater than 10,000 kg.

Information you need to show that your chemical does not have environment hazard characteristics

Read Step 5.4 of the Guide to categorising your chemical introduction

Read Use of animal test data for chemicals in cosmetics

We do not require you to have data to demonstrate the absence of hazard characteristics for many introductions (for example, PLCs and those that fall into lower environment exposure bands).

The circumstances where we do require information to demonstrate the absence of hazard characteristics to categorise your introduction are outlined in steps 4.4 and 5.4 of the Categorisation Guide. For each hazard characteristic we provide details of all acceptable alternatives that you can use instead of animal test data.

Reporting and record keeping obligations

Make sure you can meet your reporting and record keeping obligations for your introductions. For requirements that apply to all chemical introductions see our guidance on reporting and record-keeping obligations.

Do I need to complete any testing?

We need test results for your cosmetic ingredients only under very specific circumstances. They are as follows:

• Whenever we ask you to keep information about your cosmetic ingredient for record keeping purposes, this can include test results where appropriate.
• Whenever we ask you to provide information about your cosmetic ingredient for categorisation purposes, this can include test results where appropriate.

We don’t require any kind of product testing of your cosmetic. Our focus is on the ingredients of your cosmetics.

What about cosmetic injectables?

Cosmetic injections are medical procedures that involve injecting a substance under your skin to change an aspect of your appearance. These products include:

• Botox and similar neurotoxins designed to temporarily relax facial muscles
• dermal fillers

We do not regulate the chemicals in cosmetic injectables – the TGA regulates these products.

Note: The chemicals used in tattoo and permanent make-up inks are classified as industrial chemicals in Australia. Learn more about tattoo and permanent make-up (PMU) inks.