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Is my product a cosmetic?

Cosmetics include a wide range of products. They include hair dyes, bath bombs, soaps, moisturisers, perfumes, lipsticks and secondary sunscreens. We regulate the ingredients of cosmetics.

This decision tool asks you 1 to 5 questions to help you work out if we consider your product to be a cosmetic.

  • Where the product will be used.
  • What the product does to the human body.
  • Why people use your product.
  • If any of your ingredients are on a list of poisons and medicines, the Poisons Standard
  • If you’re following the relevant requirements for any of your ingredients in the Poisons Standard.

Depending on your answers, we'll tell you if your product is a cosmetic or isn't a cosmetic. If it's a cosmetic, we regulate the ingredients.

We'll give you instructions about:

  • your obligations with AICIS so you can legally import or manufacture (introduce) your cosmetic ingredients
  • who to contact to help you find out your other obligations for your product

There are a few things you should know before starting...

  • AICIS doesn’t regulate therapeutic goods. These are products which change or claim to change the way the human body works. You can read about the differences. If a product is a therapeutic good, it isn't a cosmetic.
  • We don’t ‘ban’ the use of ingredients in products. We can restrict the concentrations you can use and put other conditions on them you’ll need to follow. We’ve got detailed guidance about prohibited and restricted chemicals.
  • Most restrictions are in the Poisons Standard. The full name is the Standard for the Uniform Scheduling of Medicines and Poisons, or SUSMP.
  • We don’t have anything to do with labelling cosmetics. We’ve put together a list of who you ought to contact if you need to know about labelling.
  • We’ve got a specific definition of naturally-occurring. We’ve put together guidance explaining how our definition works.

There’s a list of exceptions you’ll need to check before you proceed. They're products that aren't therapeutic goods. The TGA maintains this list. It calls it the Therapeutic Goods (Excluded Goods) Determination (EGD). You’ll want to check your product against sections 1 and 2. If the section lists your product as not being a therapeutic good, your product may be a cosmetic. However, it would still need to meet our criteria. Remember what EGD told you when you complete the decision tool.

Question 1

For our definition of a cosmetic, it's important where the product will be used.

Will your product be used on any of the following?

  • skin
  • hair
  • nails
  • teeth
  • inside of the mouth

Question 2

For our definition of a cosmetic, it's important what the product does to the human body.

Does your product do any of the following?

  • protect the body
  • alter the body’s odours
  • perfume the body
  • change the body’s appearance (e.g. colouring, tinting or bleaching)
  • cleanse the body
  • maintain the body in good condition (e.g. moisturising, exfoliating or drying)

Not sure? Not sure? See examples of cosmetics in our glossary. Check the EGD for more. 

Question 3

For our definition of a cosmetic, it's important why people use your product.

Do you intend for your product to be used for any of the following reasons?

  • preventing, curing or alleviating a disease, ailment, defect or injury
  • influencing, inhibiting or modifying the way the body works for any reason (e.g. regenerate skin to delay ageing, reduce melanin production to whiten skin or boost metabolism to burn fat)

Not sure? See examples of cosmetics in our glossary. Check the EGD for more. 

Question 4

For our definition of a cosmetic, it's important if any of your product's ingredients are in the Poisons Standard.

Are any of your product's ingredients in the Poisons Standard?

Question 5

For ingredients in the Poisons Standard, it’s important that you’re following all relevant requirements of the Poisons Standard.

Do your product’s ingredients in the Poisons Standard follow all relevant requirements?

We don't consider your product to be a cosmetic.

This is because you've told us it:

  • isn't used on a relevant part of the human body

What do I do now?

Your product may be a therapeutic. If it is, you'll need to contact the TGA. They regulate therapeutic products. You can read our guidance on cosmetics and therapeutics.

If the TGA don’t regulate your product, we might still regulate it. This might be because the TGA doesn’t recognise the therapeutic purpose of your product. In this case, we’d regulate the ingredients as industrial chemicals. Continue to 'Further actions'.

Further actions

Use our ‘Do I need to register’ decision tool to work out if you need to register your business with us.

You don't need to register with us if any of the following apply:

  • you're re-selling chemicals you bought in Australia
  • you're mixing or blending chemicals you bought in Australia
  • you're not selling your chemical for commercial purposes

Registration and further steps

Once you’ve registered your business with us, you need to separately categorise the introduction of each ingredient in your product. Note that each ingredient could have a different introduction category. You should read our guidance about categorisation of chemicals. This includes checking each ingredient of your product in our chemical database, the Inventory. If the ingredient is on our Inventory, you need to make sure that your introduction of it meets any terms of the Inventory listing. This could include:

  • concentration limits
  • other restrictions

If your ingredient’s in the Inventory and you’re following all the terms of the Inventory listing, your introduction of it can be a listed introduction. You can read our guide to help you understand. You’ll have to:

If the ingredient's not in the Inventory, you've got to work out what introduction category applies. 

Depending on the risks of your use, you may be eligible for an exempted introduction. You’ll have to make a once-off declaration, but otherwise you’d be able to introduce it without telling us beforehand. Otherwise, you may be eligible for another category of introduction. You can read our guide to help you understand. Keep in mind each introduction category has criteria and obligations you'll need to meet.

We've put together a list of who you ought to contact to check your labelling requirements.

We don't consider your product to be a cosmetic.

This is because you've told us it:

  • doesn't do anything relevant to the human body

What do I do now?

Your product may be a therapeutic. If it is, you'll need to contact the TGA. They regulate therapeutic products. You can read our guidance on cosmetics and therapeutics.

If the TGA don’t regulate your product, we might still regulate it. This might be because the TGA doesn’t recognise the therapeutic purpose of your product. In this case, we’d regulate the ingredients as industrial chemicals. Continue to 'Further actions'.

Further actions

Use our ‘Do I need to register’ decision tool to work out if you need to register your business with us.

You don't need to register with us if any of the following apply:

  • you're re-selling chemicals you bought in Australia
  • you're mixing or blending chemicals you bought in Australia
  • you're not selling your chemical for commercial purposes

Registration and further steps

Once you’ve registered your business with us, you need to separately categorise the introduction of each ingredient in your product. Note that each ingredient could have a different introduction category. You should read our guidance about categorisation of chemicals. This includes checking each ingredient of your product in our chemical database, the Inventory. If the ingredient is on our Inventory, you need to make sure that your introduction of it meets any terms of the Inventory listing. This could include:

  • concentration limits
  • other restrictions

If your ingredient’s in the Inventory and you’re following all the terms of the Inventory listing, your introduction of it can be a listed introduction. You can read our guide to help you understand. You’ll have to:

If the ingredient's not in the Inventory, you've got to work out what introduction category applies. 

Depending on the risks of your use, you may be eligible for an exempted introduction. You’ll have to make a once-off declaration, but otherwise you’d be able to introduce it without telling us beforehand. Otherwise, you may be eligible for another category of introduction. You can read our guide to help you understand. Keep in mind each introduction category has criteria and obligations you'll need to meet.

We've put together a list of who you ought to contact to check your labelling requirements.

We don't consider your product to be a cosmetic.

This is because you've told us it:

  • has therapeutic uses

What do I do now?

You'll need to contact the TGA, who regulate therapeutic products. They'll be able to guide you on what to do next. You can read our guidance on cosmetics and therapeutics.

If the TGA don’t regulate your product, we might still regulate it. This might be because the TGA doesn’t recognise the therapeutic purpose of your product. In this case, we’d regulate the ingredients as industrial chemicals. Continue to 'Further actions'.

Further actions

Use our ‘Do I need to register’ decision tool to work out if you need to register your business with us.

You don't need to register with us if any of the following apply:

  • you're re-selling chemicals you bought in Australia
  • you're mixing or blending chemicals you bought in Australia
  • you're not selling your chemical for commercial purposes

Registration and further steps

Once you’ve registered your business with us, you need to separately categorise the introduction of each ingredient in your product. Note that each ingredient could have a different introduction category. You should read our guidance about categorisation of chemicals. This includes checking each ingredient of your product in our chemical database, the Inventory. If the ingredient is on our Inventory, you need to make sure that your introduction of it meets any terms of the Inventory listing. This could include:

  • concentration limits
  • other restrictions

If your ingredient’s in the Inventory and you’re following all the terms of the Inventory listing, your introduction of it can be a listed introduction. You can read our guide to help you understand. You’ll have to:

If the ingredient's not in the Inventory, you've got to work out what introduction category applies. 

Depending on the risks of your use, you may be eligible for an exempted introduction. You’ll have to make a once-off declaration, but otherwise you’d be able to introduce it without telling us beforehand. Otherwise, you may be eligible for another category of introduction. You can read our guide to help you understand. Keep in mind each introduction category has criteria and obligations you'll need to meet.

We've put together a list of who you ought to contact to check your labelling requirements.

We do consider your product to be a cosmetic.

This is because you've told us it:

  • is used on a relevant part of the human body
  • does relevant things to the human body
  • has no therapeutic uses
  • has no ingredients in the Poisons Standard

Further actions

Use our ‘Do I need to register’ decision tool to work out if you need to register your business with us.

You don't need to register with us if any of the following apply:

  • you're re-selling chemicals you bought in Australia
  • you're mixing or blending chemicals you bought in Australia
  • you're not selling your chemical for commercial purposes

Registration and further steps

Once you’ve registered your business with us, you need to separately categorise the introduction of each ingredient in your product. Note that each ingredient could have a different introduction category. You should read our guidance about categorisation of chemicals. This includes checking each ingredient of your product in our chemical database, the Inventory. If the ingredient is on our Inventory, you need to make sure that your introduction of it meets any terms of the Inventory listing. This could include:

  • concentration limits
  • other restrictions

If your ingredient’s in the Inventory and you’re following all the terms of the Inventory listing, your introduction of it can be a listed introduction. You can read our guide to help you understand. You’ll have to:

If the ingredient's not in the Inventory, you've got to work out what introduction category applies. 

Depending on the risks of your use, you may be eligible for an exempted introduction. You’ll have to make a once-off declaration, but otherwise you’d be able to introduce it without telling us beforehand. Otherwise, you may be eligible for another category of introduction. You can read our guide to help you understand. Keep in mind each introduction category has criteria and obligations you'll need to meet.

We've put together a list of who you ought to contact to check your labelling requirements.

We do consider your product to be a cosmetic.

This is because you've told us it:

  • is used on a relevant part of the human body
  • does relevant things to the human body
  • has no therapeutic uses
  • has ingredients in the Poisons Standard you're using for non-therapeutic reasons

Further actions

Use our ‘Do I need to register’ decision tool to work out if you need to register your business with us.

You don't need to register with us if any of the following apply:

  • you're re-selling chemicals you bought in Australia
  • you're mixing or blending chemicals you bought in Australia
  • you're not selling your chemical for commercial purposes

Registration and further steps

Be sure you're following restrictions in the Poisons Standard for your chemical.

Once you’ve registered your business with us, you need to separately categorise the introduction of each ingredient in your product. Note that each ingredient could have a different introduction category. You should read our guidance about categorisation of chemicals. This includes checking each ingredient of your product in our chemical database, the Inventory. If the ingredient is on our Inventory, you need to make sure that your introduction of it meets any terms of the Inventory listing. This could include:

  • concentration limits
  • other restrictions

If your ingredient’s in the Inventory and you’re following all the terms of the Inventory listing, your introduction of it can be a listed introduction. You can read our guide to help you understand. You’ll have to:

If the ingredient's not in the Inventory, you've got to work out what introduction category applies. 

Depending on the risks of your use, you may be eligible for an exempted introduction. You’ll have to make a once-off declaration, but otherwise you’d be able to introduce it without telling us beforehand. Otherwise, you may be eligible for another category of introduction. You can read our guide to help you understand. Keep in mind each introduction category has criteria and obligations you'll need to meet.

We've put together a list of who you ought to contact to check your labelling requirements.

We don't consider your product to be a cosmetic.

This is because you've told us it:

  • has ingredients in the Poisons Standard you're using for therapeutic reasons

What do I do now?

You'll need to contact the TGA, who regulate therapeutic products. They'll be able to guide you on what to do next. You can read our guidance on cosmetics and therapeutics.

If the TGA don’t regulate your product, we might still regulate it. This might be because the TGA doesn’t recognise the therapeutic purpose of your product. In this case, we’d regulate the ingredients as industrial chemicals. Continue to 'Further actions'.

Further actions

Use our ‘Do I need to register’ decision tool to work out if you need to register your business with us.

You don't need to register with us if any of the following apply:

  • you're re-selling chemicals you bought in Australia
  • you're mixing or blending chemicals you bought in Australia
  • you're not selling your chemical for commercial purposes

Registration and further steps

Be sure you're following restrictions in the Poisons Standard for your chemical.

Once you’ve registered your business with us, you need to separately categorise the introduction of each ingredient in your product. Note that each ingredient could have a different introduction category. You should read our guidance about categorisation of chemicals. This includes checking each ingredient of your product in our chemical database, the Inventory. If the ingredient is on our Inventory, you need to make sure that your introduction of it meets any terms of the Inventory listing. This could include:

  • concentration limits
  • other restrictions

If your ingredient’s in the Inventory and you’re following all the terms of the Inventory listing, your introduction of it can be a listed introduction. You can read our guide to help you understand. You’ll have to:

If the ingredient's not in the Inventory, you've got to work out what introduction category applies. 

Depending on the risks of your use, you may be eligible for an exempted introduction. You’ll have to make a once-off declaration, but otherwise you’d be able to introduce it without telling us beforehand. Otherwise, you may be eligible for another category of introduction. You can read our guide to help you understand. Keep in mind each introduction category has criteria and obligations you'll need to meet.

We've put together a list of who you ought to contact to check your labelling requirements.

We don't consider your product to be a cosmetic.

This is because you've told us it:

  • has ingredients in the Poisons Standard and you're not following all restrictions for the ingredients

What do I do now?

Your product may be a therapeutic. If it is, you'll need to contact the TGA. They regulate therapeutic products. They'll be able to guide you on what to do next. You can read our guidance on cosmetics and therapeutics.

For more information on banned and restricted chemicals, read our guidance.

For any questions about the Poisons Standard, contact state and territory regulators.

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