What are toothpaste and oral hygiene products?
Maintaining oral health requires the use of dental hygiene products and cosmetic toothpaste. The following are some of them:
- Pastes, gels, powders
- mouth washes
- breath fresheners
What regulations apply to toothpastes?
Toothpaste and oral hygiene products may be considered therapeutic or cosmetic in Australia, depending on:
- Product presentation or advertisement
- Describe the product’s claims
- How the product is intended to be used
- Ingredients in a product
The Therapeutic Goods Administration (TGA) must approve Toothpaste suppliers or oral hygiene products marketed as medicines or having therapeutic effects. In order to qualify as a ‘therapeutic’ item, a tooth paste or dental hygiene product must:
- Determination 2018 Intended Use (Excluded Goods) – These goods do not meet the criteria
- Certain cosmetic ingredients are prohibited by the Poisons Standard
- Claim of phytotherapeutic properties
For example:
- According to its label, mouthwash is a therapeutic product for preventing gingivitis
- An item named as a therapeutic good on its label must cure gingivitis
TGA regulation regarding toothpaste and oral hygiene products is exempted by the Therapeutic Goods (Excluded Goods) Determination 2018, since they are categorized as cosmetics.
The following criteria must be met for us to regulate the ingredients in these products:
- There is no application of Standard Schedules 2, 3, 4 and 8 to them
- Advertisements or product lists describe the benefits associated with improved oral health, such as preventing tooth decay with fluoride.
- Aside from the benefits claimed for preventing gum disease and periodontal disease, the product offers no other health benefits.
Manufacturers or importers of cosmetic toothpaste have what obligations?
Registration
The Australian government regulates cosmetic toothpaste manufacturers and oral hygiene products containing industrial chemicals. You must register your business before importing, manufacturing (or otherwise introducing) these products commercially. Your business needs to be registered with us, not your products.
No matter whether another company imports the same (or similar) chemicals, the registrant must still register.
Categorisation
You must list any chemical in oral hygiene and cosmetic toothpastes under one of our five categories:
- Listed
- Exempted
- Reported
- Assessed
- Permission to evaluate commercially
There are different categories of obligations based on the potential health and environmental impact of your introduction.
Reporting
In order to import or manufacture cosmetic toothpaste and oral hygiene products containing ingredients approved under our exempted category of environmental and human health risk (‘very low risk’) you must submit a once-off exempted introduction declaration. The requirements for your annual declaration are separate from this one.
Those cosmetic toothpastes and oral hygiene products containing ingredients under our Low Risk category (‘low risk’) require a one-time pre-introduction report. In addition to this requirement, you have annual declaration obligations.
