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Register your business for the 2020-21 registration year

Cosmetics with sunscreen

In Australia, most secondary sunscreens are classed as cosmetic products. If you’re importing or manufacturing (‘introducing’) a product that meets the criteria for a cosmetic with sunscreen, you must register with us. If you’re blending ingredients purchased in Australia, you do not need to register. 

Who regulates cosmetics with sunscreen? 

We’re often asked who is responsible for regulating the introduction of cosmetics that contain sunscreen in Australia. It depends on whether the product meets the legal definition of a ‘therapeutic’ or a ‘cosmetic’. 

The Therapeutic Goods Administration (TGA) regulates therapeutic sunscreens, including: 

  • primary sunscreens - products used primarily for protection from UV radiation that have a rated sun protection factor (SPF) of 4 or more 
  • some secondary sunscreens - such as moisturisers that contain sunscreen with an SPF greater than 15 
  • sunscreens with an SPF of 4 or more that contain an insect repellent 
  • sunscreens with specific ingredients listed in Schedule 5 of the Therapeutic Goods Regulations 1990 

We are responsible for regulating the introduction of the ingredients in cosmetic sunscreens that meet all the relevant requirements of the Therapeutic Goods (Excluded Goods) Determination 2018, including: 

  • products applied to the lips (such as lipsticks and lip balms) that contain sunscreen with an SPF of 4 or more 
  • tinted bases and foundations (including liquids, pastes and powders) that contain sunscreen with an SPF of 4 or more 
  • moisturising skin-care products that contain sunscreen with an SPF of 15 or less, that are in a pack size no larger than 300ml or 300g 
  • sunbathing skin-care products with sunscreen that contain an SPF between 4 and 15, and are in a pack size no larger than 300ml or 300g 

Note that a cosmetic sunscreen product must meet the legal definition of a cosmetic. Learn more about the difference between cosmetics and therapeutics

What are my obligations? 

Registration 

Ingredients in products that contain sunscreen and meet the definition of cosmetics and all the relevant requirements of the Therapeutic Goods (Excluded Goods) Determination 2018 are regulated as industrial chemicals in Australia. Therefore, you must register your business with us before you import or manufacture (‘introduce’) these types of products for commercial purposes. You register your business with us, not your products or ingredients. 

Registration applies even if another business is already importing the same (or similar) chemicals. Learn more about registration and who must register

Note: If you are blending ingredients purchased in Australia, you do not need to register with us. Learn more about the difference between blending and manufacturing chemicals

Categorisation 

Every industrial chemical in a cosmetic with sunscreen that you want to introduce must be authorised under 1 of our 5 main categories:

  • Listed (on our Inventory) 
  • 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. 

Reporting 

If you’re introducing cosmetics with sunscreen that contain 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 cosmetics with sunscreen that contain ingredients 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 cosmetics with sunscreen that contain 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 compliance, reporting and record-keeping obligations.

Annual declarations 

Regardless of the introduction category, you must submit an annual declaration at 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. 
 

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: 

Does your product include a flavour or fragrance chemical? 

Cosmetics with sunscreen often include flavour and fragrance chemicals. 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 category. 

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. 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

Frequently asked questions 

Q. I want to import a product that is a moisturiser and tinted face cream, but also has a sunscreen. Is this product considered to be a secondary sunscreen and therefore exempt from TGA approval? 

In Australia, tinted bases and foundations (including liquids, pastes and powders) that contain sunscreen with an SPF of 4 or more are classed as cosmetics if they meet the definition of a cosmetic and comply with all the relevant requirements of the Therapeutic Goods (Excluded Goods) Determination 2018. You will need to register your business with us and categorise the chemical ingredients in your product before you introduce it into Australia. 

Q. How do the new AICIS regulations affect cosmetic sunscreens? 

If your product meets the criteria for a cosmetic sunscreen, you must register your business with us before you introduce the product into Australia. 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 would like to confirm the packaging and labelling requirements for cosmetic sunscreens. 

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

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