PRIMARY SUNSCREENS AND COSMETIC SUNSCREENS

Australian sunscreens legislation and standards are among the most complex in the world – products are regulated differently depending on whether or not they also have a cosmetic function.

a) Primary sunscreens (with no cosmetic function) are therapeutic products – this means they must be produced in a TGA approved facility approved to medicinal standards.

b) Secondary sunscreens (which included a cosmetic function) are divided into two groups –

        • Moisturisers which are regulated as cosmetics (up to SPF 15) or as therapeutic products (up to SPF 50+)
        • Colour and Lip products which are cosmetics up to SPF50+

c) Sunscreens must also comply with the AS/NZ52604 2012 . This standard separates sunscreens into primary sunscreens and secondary sunscreens based on purpose.

As the regulatory and test requirements vary based on the above we have prepared a summary of  sunscreen classification which can be found here .

TABLE OF SUNSCREEN TGA NICNAS SPF BROADSPECTRUM TESTING FOR TGA AICIS NICNAS - AU AND NZ
Click to enlarge

Engel Hellyer & Partners founding Directors were participating members in the development of the standard dating back to initial discussions in 1977 and our involvement has continued ever since! The first standard was commissioned to the Federal Government and issued in 1983. The seventh revision of the standard is currently under way.

Therapeutic Sunscreens
Click here to read about Therapeutic Sunscreens

Therapeutic sunscreens have the following requirements

a) They must be made in a TGA approved facility. Local facilities are inspected by the TGA and give a GMP license for 1-4 years if approved. Overseas facilities may qualify for TGA licens under the expedited MRA (EU, Canda) whereas other sites require a more detailed TGA Compliance Verification such as those in USA. Other facilities may require inspections by TGA and they may cost approximately $50,000 every 1-3 years. We are experienced with all of these processes and can advise you accordingly.

b) All the ingredients must be known to the TGA and be on a list known as Therapeutic Products (Permitted Ingredient) Determinations 2020. This list is regularly updated. Ingredients not on the list will need to be evaluated for safety by the TGA.

c) All product formulas and claims need to be approved by the TGA and a number (AUSTL xxxx) assigned to be displayed on packs.

d) Other items include: unique labeling pharmacovigilance and therapeutic product recall adherence and stability tests.

Cosmetic Sunscreens
Click here to read about Cosmetic Sunscreens

Cosmetic sunscreens have the following requirements

a) Must meet the definitions for cosmetic sunscreens according to the Standard.

b) Cosmetic sunscreens ingredients are also individual chemicals and hence need to meet all the introduction requirements of the regulator, Australian Industrial Chemical Introduction Scheme (AICIS) from 1 July 2020 (known as NICNAS prior to 1 July 2020).

c) All the other requirements in regard to ingredient labeling for cosmetics, unit measure, placement size, country of origin and poison standards apply.

Sunscreen regulations compliance and advice. Sunscreen classification and claims restrictions usually require in-depth guidance which we are well-placed to provide. Please feel free to contact us to discuss further.