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Antibacterial skin care products

Antibacterial skin care products are determined to be either therapeutic goods or cosmetics, based on their composition, proposed use and the way they’re marketed. 
 

What are antibacterial skin care products? 

Antibacterial skin care products are applied to the surface of the skin and contain ingredients that destroy bacteria or suppress their growth or ability to reproduce. They include: 

  • cleansers and gels 
  • face scrubs 
  • masks 
  • anti-bacterial hand lotions 
  • sanitisers 
  • wipes 

Note: Due to COVID-19, we’ve received a lot of enquiries about hand sanitisers. Learn more about the regulation of hand sanitisers in Australia. 

Who regulates antibacterial skin care products? 

In Australia, antibacterial skin care products are regulated as either therapeutic goods or cosmetics, depending on: 

  • how the product is advertised or presented for supply 
  • the claims made for the product 
  • the product’s intended use 
  • the product’s ingredients 

Under the Therapeutic Goods (Excluded Goods) Determination 2018, certain products are considered to be of lower regulatory risk and are excluded from regulation by the TGA under certain circumstances. 

The Therapeutic Goods Administration (TGA) is responsible for regulating antibacterial skin care products that are medicines or marketed as having therapeutic effects, including: 

  • products that are presented or promoted for use in hospitals or other health care settings, or in connection with medical conditions 
  • products that claim to be active against any micro-organisms other than bacteria, such as ‘effective against viruses’ 

We’re responsible for regulating the chemical ingredients in these products excluded from regulation by the TGA, including antibacterial skin care products that do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard, and are advertised or presented as being active against bacteria. 

However, they must not be advertised or presented as being: 

  • active against viruses, fungi or other microbial organisms (other than bacteria) 
  • for use in connection with disease, disorders or medical conditions 
  • active against a named bacterium that is known to be associated with a disease, disorder or medical condition 
  • for use in connection with piercing of the skin or mucous membrane, for cosmetic or any other purpose 
  • for use in connection with any procedure associated with the risk of transmission of disease from contact with blood or other bodily fluids 
  • for use before physical contact with a person who is accessing medical or health services, or who is undergoing any medical or health care procedure 
  • for use in connection with a procedure involving venepuncture or delivery of an injection 

Still not sure? Our decision tree tool can help you determine whether the ingredients in your product are cosmetics or therapeutic goods

What are my obligations if I want to import or manufacture antibacterial skin care products? 

Registration 

Ingredients in antibacterial products that 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 your product is formulated in Australia by blending (mixing) ingredients that you bought locally in Australia, you do not need to register with us for this purpose.

Learn more about the difference between blending and manufacturing chemicals.

Categorisation 

Every industrial chemical in the antibacterial skin care products 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. 

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

Reporting 

If you’re introducing antibacterial skin care 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 antibacterial skin care products containing 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 antibacterial skin care products 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? 

Antibacterial skin care products may include flavour and fragrance chemicals. If the chemical identity of these ingredients is 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 ask0ed questions 

Q. I am planning to import an anti-bacterial hand lotion. Would you please confirm the packaging and labelling requirements for this type of product? 

First, you will need to check whether your product is regulated as a therapeutic good or a cosmetic. 

If your product is a cosmetic, it must comply with the mandatory standard for cosmetic labelling, which includes the listing of ingredients, and any other relevant regulations. 

Note that we don't set or enforce labelling requirements for 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 have developed my own anti-bacterial hand wash using natural ingredients, and I want to sell it at my local outdoor market. Do I need to register with you? 

You will need to check the Therapeutic Goods (Excluded Goods) Determination 2018 to make sure you are not advertising your hand wash as a therapeutic good. 

If you’ve purchased the ingredients for your hand wash locally and simply blended them to make your products, then you don’t need to register with us. (The Australian business that 

imported the ingredients must register with us.) Learn more about the difference between blending and manufacturing chemicals

If all the ingredients in your products meet our legal definition of a naturally occurring chemical (and you don’t introduce any other industrial chemicals), then you do not need to register with us. 

However, if you are using any ingredients that are not naturally-occurring chemicals and you’ve manufactured those ingredients yourself or imported the ingredients for your hand wash from overseas, and you will be selling your product for a profit over and above the cost of the ingredients, then you must register your business with us for this purpose. 

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

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