In Australia, cosmetics that contain sunscreens (UV filters) are regulated by the Health Authority Therapeutic Goods Administration (TGA). It is important to understand that in Australia almost all cosmetic ingredients are regulated as industrial chemicals, this includes those described as ‘natural’ or ‘organic’ such as oils and extracts.The cosmetic can only be approved for market if it meets the legal definition of either ‘therapeutic’ or ‘cosmetic’.
Therapeutic Vs Cosmetic
Products are determined to be either ‘cosmetics’ or ‘therapeutic goods’ based on three factors:
- the primary use of the product
- the ingredients in the product
- the claims made about the product
A cosmetic product is a substance designed to be used on any external part of the body – or inside the mouth – to change its odour or appearance, cleanse it, keep it in good condition or protect it.
A therapeutic product is used to prevent, diagnose or treat a disease or its symptoms, or affect the structure or functions of the human body.
Therapeutic sunscreens can include:
- Primary Sunscreens: products having a Sun Protection Factor (SPF) of 4 or more and are primarily used for the protection from UV radiations
- Secondary Sunscreens: these products include SPF of 15 or more and are added as a secondary purpose, for example with moisturizers.
- Some insect repellant having SPF or 4 or sunscreens with specific ingredients included in Schedule 5 of TGA 1990.
Ingredients in Cosmetic Sunscreens:
Ingredients that meet all the relevant requirements of Therapeutic Goods (Excluded Goods) Determination 2018 like:
- Products containing SPF 4 or more applied to lips, foundations and tinctures
- Products containing SPF between 4 and 15 and are sunbathing or moisturizing skin-care products having a pack size up to 300ml or 300g.
To register a product containing sunscreen and which meet the definition of cosmetics as per the Therapeutic Goods, manufacturers should:
Every chemical to be introduced in Australia should be authorized under 1 of the following:
The manufacturer should follow the following obligations for reporting cosmetics with sunscreens that contain ingredients that are:
|Record Keeping||Records should be maintained for 5 years for the introduced chemicals irrespective of the chemical in the market.|
|Annual Declaration||These are submitted at the end of every year to confirm the introduction of chemicals are authorized under TGA’s laws.|
Since July 1,2020 Australia banned the use of new animal test data for ingredients solely used in cosmetics. If the chemical ingredients has multiple end uses including its use in a cosmetic the manufacturer must confirm that the ingredient complies with the rules on using animal test data.
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