Personal care, skincare, make-up and other cosmetic products

What are personal care, skin care, make-up and cosmetic products?

Most personal care, skin care, make-up and cosmetic products may be described as ‘cosmetics’. A cosmetic is defined in our legislation as a substance or preparation intended for placement in contact with any part of the human body, including the mucous membranes of the oral cavity and the teeth, with a view to:

• altering the odours of the body
• changing its appearance
• cleansing it
• maintaining it in good condition
• perfuming it
• protecting it

Cosmetics include soap, shampoo and conditioner, moisturiser, 'bath bombs', hair dye, perfume, lipstick, mascara, nail polish, deodorant and many other products.

However, items such as tissues, cotton swabs and nail files are defined as ‘articles’ and are not regulated as industrial chemicals.

Learn more about how we define an article.

We’re often asked who is responsible for regulating the introduction of cosmetic products in Australia. It’s best described as a process of exclusion:

• The Therapeutic Goods Administration is responsible for regulating chemicals in personal care, skin care, make-up and cosmetic products that are medicines or marketed as having therapeutic effects. This includes most skin-whitening lotions, primary sunscreens, disinfectants, complementary medicines and blood products.
• We’re responsible for regulating the chemical ingredients in personal care, skin care, make-up and other cosmetic products that are not medicines or marketed as having therapeutic effects. These ingredients are therefore considered to have an 'industrial' use.

Learn more about the difference between cosmetics and therapeutics. 

If you’re not sure, our decision tool can help you determine whether your product is a cosmetic or therapeutic good. 

Complete our self-guided decision tool: Is my product a cosmetic?

It’s important to note that almost all cosmetic ingredients are regulated as industrial chemicals, including those described as 'natural' or 'organic' such as oils, extracts and plant essences. Chemicals that meet our definition of a ‘naturally occurring chemical’ are still industrial chemicals, but are excluded from some legal obligations.

Download our information sheet

Our information sheet explains whether you need to register with AICIS if you make or import cosmetics. Click on the image to view and download the PDF file:
 

What are my obligations as an importer or manufacturer of cosmetics?

Registration

Importers

If you plan to sell any cosmetics in Australia that you bought from overseas, you must register your business with us before you import (introduce) into Australia. There is no threshold value or limit so you must register regardless of how much you sell.

Registration still applies for these situations:

• even if another business is already importing the same (or similar) chemicals or products
• the cosmetics are branded and fully packaged
• you are importing a small number or low quantity of cosmetics

Learn more about registration and who must register.

Manufacturers (including home-based and small businesses)

If you intend to make cosmetics for sale in Australia where one or more ingredients were purchased from overseas, then you must register your business with us beforehand. There is no threshold value or limit so you must register regardless of the quantity and how much you sell.

If you purchase all ingredients locally and you blend these together to make your cosmetics, then you don't need to register with us. But if your process of mixing ingredients results in a chemical reaction, then we consider this to be manufacturing and you must register with us.

Categorisation

Every relevant industrial chemical in the personal care, skin care, make-up and cosmetic products that you want to introduce must be authorised under one of our 5 main categories:

• Listed
• Exempted
• Reported
• Assessed
• Commercial Evaluation Authorisation

Your obligations for each category will depend on the level of risk to human health and the environment from your introduction.

We don’t generally regulate the chemical ingredients of articles unless the article is designed to release the chemical. 

Reporting

If you’re introducing personal care, skin care, make-up and cosmetic products containing ingredients that are authorised under our exempted category ('very low risk' to human health and the environment), you must submit a once-off exempted introduction declaration after you import or manufacture them. This obligation is separate to your annual declaration obligations.

Learn more about exempted introduction declarations.

If you’re introducing personal care, skin care, make-up and cosmetic products that are authorised under our reported category ('low risk' to human health and the environment), you must submit a once-off pre-introduction report before you import or manufacture them. This obligation is separate to your annual declaration obligations.

Learn more about pre-introduction reports. 

If you’re introducing personal care, skin care, make-up and cosmetic products containing ingredients that are not on the Inventory and are in the assessed category, you must apply for an assessment certificate before you can introduce the chemicals. 

Learn how to apply for an assessment certificate.

Record keeping

You must keep certain records about your chemical introductions to confirm they comply with our laws. You must keep these records for 5 years, even after you’ve stopped introducing your chemical.

Learn more about your reporting and record-keeping obligations.

Annual declarations

Regardless of the introduction category, you must submit an annual declaration by 30 November after the end of every registration year. This is a declaration you make about the industrial chemicals you imported or manufactured in the previous registration year and confirms that your introductions were authorised under our laws.

Learn more about annual declarations.

Other government standards

If your introduction is for an end use in cosmetics or consumer goods, you must ensure that it complies with other government standards including those established by:

• the Poisons Standard
• the Mandatory Standard for Labelling Cosmetics

See also:

• Difference between blending and manufacturing
• Making products to sell using imported or local ingredients
• Business or hobby

Does your product include a flavour or fragrance chemical?

Personal care, skin care, make-up and cosmetic products often include flavour and fragrance chemicals and blends. If the chemical identity of these ingredients are protected as a trade secret, you can choose to introduce them using the ‘reported introduction — low-risk flavour or fragrance blend’ pathway — without going through the process of working out the highest indicative risk. However, they must meet the requirements of this pathway.

If you use this pathway, you will need to nominate a chemical data provider who can provide information about the chemicals.

Learn more about categorisation of flavour and fragrance blends.

Use of animal test data

The ban on the use of new animal test data for ingredients solely used in cosmetics started on 1 July 2020. There are also restrictions on using new animal test data for chemicals with multiple end uses (including in cosmetics). If the chemical ingredients you want to introduce have an end use in cosmetics (or multiple end uses that include cosmetics), you must confirm that you have complied with the rules on using animal test data to categorise your introduction.

You do this when you either:

• submit an exempted introduction declaration (if relevant)
• submit a pre-introduction report (if relevant)

Learn more about the rules on using animal test data.

Which chemicals are allowed in cosmetics?

We're often asked which chemicals are 'allowed' in cosmetics. However, in Australia there is no single list of chemicals that are banned or restricted in products. The best place to start is the Standard for the Uniform Scheduling of Medicines and Poisons – also known as the Poisons Standard. This is a record of decisions about the classification of medicines and chemicals used in consumer products. It may be helpful to refer to this resource when determining if you can market your product as a cosmetic.

You can also refer to our page on banned or restricted chemicals for more information on the regulation of chemicals in Australia.

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.

Frequently asked questions

Q. I’m trying to register my products in Australia. Can you please advise the correct category for registering cosmetics, and any other requirements?

If your products contain ingredients that are regulated as industrial chemicals, you must register with us. Note that you register your business with us, not the ingredients or products. Learn more about registration and who must register.

After registering, you must check that each ingredient in the product you want to introduce is listed on the Inventory. If an ingredient is not listed on the Inventory, you must categorise it as an exempted, reported or assessed introduction.

Q. I can’t find one of the ingredients in my product on the Inventory. How do I find out whether there are any restrictions or regulations attached to its introduction?

There are several reasons why you may not be able to find a chemical on our Inventory:

• it doesn’t need to be listed because it's a chemical that’s legally defined as ‘naturally-occurring’
• it’s on our comparable chemicals list
• it's available to introduce but the information is protected as confidential business information
• it’s not listed and is new to Australia

You can ask us to find out if a chemical is protected as confidential business information. However, we need to be satisfied you are genuinely intending to manufacture or import the chemical.

Learn more about what to do if you can't find your chemical on the Inventory

Q. I am looking to start a skin care line using natural products from plants. Do I still need to register? How do I go about getting the product tested and approved?

Firstly, you should read our legal definition of a naturally-occurring chemical. If the ingredient is NOT legally defined as naturally occurring, then it’s regulated as an industrial chemical.

If this is the case — and you plan to import the ingredients for your products from overseas — you must register with us and check if the ingredients are listed on our Inventory.

This is because many ingredients that are described as 'natural' or 'organic’ are made using a process that involves a chemical reaction — such as steam distillation or solvent extraction.

Learn more about organic and natural ingredients.

However, if you’re buying the ingredients locally and simply blending them to make your products, then you don’t need to register with us.

Learn more about the difference between blending and manufacturing chemicals.  

We don’t test or approve products. Whether a product needs to be tested or approved under other legislation depends on the type of product and the ingredients. 

Q. I would like to confirm the packaging and labelling requirements for a direct-to-public teeth-whitening system.

Consumer and cosmetic products must comply with Australian laws for labelling and product safety. However, we don't set or enforce labelling requirements for consumer and cosmetics in Australia and we don’t provide specific advice about this.

For more help on this topic, see labelling, SDS and packaging.

Q. I am planning to start an online retail shop for Korean and Japanese skin-care products. Do I need to register to sell to Australian customers?

Registration depends on whether you’re introducing cosmetics that contain ingredients regulated as industrial chemicals for personal, hobby or commercial use.

If your online business is located overseas and you sell a cosmetic product to an Australian customer for their personal use, the customer doesn’t need to register with us for this purpose.

But if your online business sells cosmetic products to an Australian customer — and the customer resells the products for a profit — we consider it to be commercial use and the customer must register their business with us for this purpose.

If your online business is located in Australia and you import or manufacture products to sell for a profit, you must register your business with us for this purpose.

Learn more about whether you’re running a business or hobby.

Need help?

Contact us to ask a question, request information or give feedback.