1. Home
  2. News

Australia New TGA Excluded Goods Determination Replaces Cosmetic Standard 2007 from October 1st

  •   12 Nov 2018
  •    Winnie Xu
  •  564
  •   Post a comment

     Takehome: On October 19, Australia NICNAS announced that Cosmetic Standard 2007 has been repealed and replaced by a new instrument—Therapeutic Goods (Excluded Goods) Determination 2018 (effective Oct 1st 2018).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. Examples of their differences in regard to claims are listed below:

    Different Claims between Cosmetics and Therapeutic Products

    Cosmetics

    Therapeutic products

    Soothes dry skin

    Relieves rashes

    Covers pimples

    Heals pimples

    Smooths wrinkles

    Aids in repair of skin tissue

    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.

    You are a visitor, Please login.

    Share this:

    ABOUT THE AUTHOR

    ChemLinked Editor

    She has expertise in China cosmetic regulations especially in CBEC, cosmetic registration/filing compliance requirements.

    COPYRIGHT: You may circulate web links to the web and contents, but they are intended for your personal, non-commercial use only. For other use of any materials, you can contact with editor@chemlinked.com to seek consent. Find out more about our copyright policy here.
    CORRECTIONS: we do our best to provide you with accurate information. However sometimes errors slip under the radar. If you notice any errors contact us on: editor@chemlinked.com
    Content sharing or co-authoring: just send messages to our editor team.