Cosmetics Registration in Australia
Regulatory Authority:
Therapeutic Goods Administration (TGA)
Link for RA:
Local regulation:
Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act)
Who can register :
- Manufacturers
- Importers
Data to be communicated :
- Commercial evaluation permit application CEC application form
- The total quantity of chemicals to be introduced, including a written explanation justifying the quantity
- The total time period for the introduction
- Use of the chemical, clearly indicating the purpose for which it is being evaluated—describe distribution arrangements and identify all users, including end-users
- Details of previous or current permits for the chemical, with particulars, if you know of permits previously issued in Australia for the chemical under any legislation, including the Act
- A User Agreement that you and each proposed user of the chemical have signed, indicating you will comply with permit conditions
- A summary of the chemical’s occupational health and safety, public health and environmental effects
- Information about the chemical
- Any application for exempt (confidential) information, with your payment
- The CEC checklist indicates which items on the CEC application form you have completed and items for which you are applying for confidential information
- A statement that you are entitled to use and to give NICNAS all the data in the notification statement
- A declaration that you have submitted all available information
Process:
After business registration and before importing and manufacturing a cosmetic, enterprises must check if all the cosmetic ingredients of a product are listed in the AICS and comply with the conditions of usage. If yes, the product can be imported or manufactured without notifying NICNAS, provided it meets any relevant requirements. Suppose any one of the ingredients is not listed on the Inventory or has a condition of use different to the intended use. In that case, it is a new industrial chemical in Australia. Unless an exemption applies, the new industrial chemical will need to be notified and assessed by NICNAS for environmental and human health risks before importing and manufacturing.
Once enterprises have established the necessity to notify NICNAS about the new chemical to import or manufacture (excluding a chemical introduced under an exemption), they will have to determine the most appropriate notification category.
Timeframe and fees:
The registration cost is a flat fee plus a charge that depends on the total value of industrial chemicals that you imported and/or manufactured (introduced) in the previous financial year (1 July -30 June).