Sunscreen legislation and Sunscreen Standards in Australia are the most complex in the world.
Marketers need to be aware that:
a) All primary sunscreens are therapeutic products
b) Sunscreens must comply with the AS/NZ52604 2012 requirements. This standard separates sunscreens into primary sunscreens and secondary sunscreens based on purpose.
c) Secondary sunscreens are divided into two groups –
- Secondary Sunscreen – Skin Care which are therapeutic products over SPF15 and;
- Secondary Sunscreen – Colour Cosmetic and Lip Products which are cosmetics.
A summary of the sunscreen classification can be found HERE Sunscreen Categories EHP 01072020
Engel Hellyer & Partners’ Directors have been participating members in the development and updating of the Australia and New Zealand Sunscreen Products Standard since 1977. The first standard was commissioned to the Federal Government and issued in 1983. The seventh revision of the standard is currently under way.
If you are interested in the requirements for therapeutic sunscreens please click here
If you are interested in importing or manufacturing cosmetic sunscreens please click here
Sunscreen classification and claims restrictions usually require some guidance and can be provided by Engel Hellyer & Partners in depth. To contact us click here
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 1-3 years if approved. Overseas facilities may qualify for TGA check claims such as those in USA or NZ. Other facilities will require inspections by TGA and they may cost approximately $50,000 every 1-3 years.
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 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) for 1 July 2020. Current regulator is NICNAS.
c) All the other requirements in regard to ingredient labeling for cosmetics, unit measure, placement size, country of origin and poison standards apply.