Takehome: On October 19, Australia NICNAS announced that Cosmetic Standard 2007 has been repealed and replaced by a new instrument—Therapeutic Goods (Excluded Goods) Determination 2018 (effective Oct 1st 2018).

The new determination is formulated by Therapeutic Goods Administration under section 7AA of Therapeutic Goods Act 1989 which excludes a number of goods from the operation of the 1989 Act. Key elements of the new determination are highlighted below:

1   Cosmetic Standard 2007’s relevant requirements of therapeutic goods have been reproduced directly in the new determination. Namely cosmetic products that are imported, exported or supplied in Australia in a manner consistent with the terms of exclusion included in the previous standard will continue to be exempted from stringent regulatory requirements of therapeutic goods under the new TGA exclude goods determination. Stakeholders’ obligations in respect of cosmetic ingredients and cosmetic products are essentially the same as before.

2   Topical antiperspirants and ear candles are currently excluded from therapeutic goods regulatory framework. Chemicals in these products are now subject to registration obligations stipulated under the Industrial Chemicals (Notification and Assessment) Act.

Therapeutic products

Generally, therapeutic products refer to products that possess similar attributes of cosmetics and are intended for therapeutic use, such as primary sunscreens. The difference between therapeutic products and cosmetics is not always clear. Product claims are one of the key factors to distinguish between the two.

Excluded goods are therapeutic products to some extent and fall under the TGA’s oversight, but they are subject to considerably relaxed regulatory requirements including GMP compliance exemptions.

Source: Chemlinked by REACH14H Consulting Group