Sunscreen Regulation in Australia – What you need to know
If you are thinking about importing or manufacturing sunscreens here in Australia, one of the things you need to do understand is whether your sunscreen is regarded as Primary (Therapeutic) or Secondary (Cosmetic). Depending on which type your sunscreen falls under will depend on which government body it is regulated by, and what requirements you must follow to ensure it meets the specific regulations.
Primary Sunscreens – regulated by the Therapeutic Goods Administration (TGA)
- Products primary function is protection from UV Radiation SPF4 or more
- Moisturisers containing sunscreen with SPF Greater than 15.
- All sunscreens (PF4 or more) that contain an insect repellent
- Sunscreens with ingredients that are from humans or particular organs from:
- Cows, sheep, goats, mule deer.
Secondary Sunscreens – regulated by ACCC and NICNAS
- Moisturisers with Sunscreen with SPF rating up to 15
- Sunbathing products (oils, creams or gels, including products for tanning without sun and after sun care products) with SPF rating between 4 and 15
- Make-up products (tinted bases and foundations) any SPF
- LIP-STICKS and LIP-BALMS with sunscreen with any SPF.
NB: Cosmetic products presented as primary sunscreens, because of labelling issues, will be treated as primary sunscreens.
Once you have figured out whether your Sunscreen type is a Primary or Secondary, you must ensure they follow the particular requirements below.
Primary Sunscreens – Particular Requirements
- List with the TGA to obtain an AUST L number
- Obtain approval of the manufacturing site. GMP Medicinal standard.
- Tested to AS/NZS 2604:2012 and reproducibility of test results
- Use permitted ingredients
- Responsibility to report adverse reactions
- Stability testing
Secondary Sunscreens – Particular Requirments
- Primary function is as a cosmetic
- No therapeutic claims
- No claims of sun protection, prevention of burns, cancer etc
- If making SPF claims, they must be supported
- Testing needs to be done to AS/NZS 2604:2012
- Ingredients must meet NICNAS, SUSMP regulations.
- Packaging/labelling to meet ACCC and SUSMP (where applicable).
Our Consultants can guide you through each step of the process.
- Check Ingredients
- List the products on the ARTG
- Check you have the appropriate Permissible Indications
- Help get the Evidence for the claimed indications
- Check your Labels and Advertising for compliance
- If you Toll Manufacture. Help find a Manufacturer
- If you set-up own manufacturing
– Prepare GMP Processes and Documentation
– Recruit Staff
– Perform Audits
• Or use selectively for advice in areas of concern.